<SEC-DOCUMENT>0001171843-25-005815.txt : 20250910
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<ACCEPTANCE-DATETIME>20250910090046
ACCESSION NUMBER:		0001171843-25-005815
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		15
CONFORMED PERIOD OF REPORT:	20250909
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20250910
DATE AS OF CHANGE:		20250910

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Arbutus Biopharma Corp
		CENTRAL INDEX KEY:			0001447028
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		EIN:				980597776
		STATE OF INCORPORATION:			A1
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-34949
		FILM NUMBER:		251304777

	BUSINESS ADDRESS:	
		STREET 1:		701 VETERANS CIRCLE
		CITY:			WARMINSTER
		STATE:			PA
		ZIP:			18974
		BUSINESS PHONE:		604-419-3200

	MAIL ADDRESS:	
		STREET 1:		701 VETERANS CIRCLE
		CITY:			WARMINSTER
		STATE:			PA
		ZIP:			18974

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	TEKMIRA PHARMACEUTICALS Corp
		DATE OF NAME CHANGE:	20110607

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	TEKMIRA PHARMACEUTICALS CORP
		DATE OF NAME CHANGE:	20081003
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<p style="margin: 0; font-size: 10pt; text-align: center"><span style="font-size: 14pt"><b>UNITED STATES</b></span></p>

<p style="margin: 0; font-size: 10pt; text-align: center"><span style="font-size: 14pt"><b>SECURITIES AND EXCHANGE COMMISSION</b></span></p>

<p style="margin: 0; font-size: 10pt; text-align: center"><b>WASHINGTON, D.C. 20549</b></p>

<p style="margin: 0; font-size: 10pt">&#160;</p>

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<p style="margin: 0; font-size: 10pt">&#160;</p>

<p style="margin: 0; font-size: 10pt; text-align: center"><b>CURRENT REPORT</b></p>

<p style="margin: 0; font-size: 10pt; text-align: center"><b>Pursuant to Section&#160;13 OR 15(d)&#160;of The Securities Exchange Act
of 1934</b></p>

<p style="margin: 0; font-size: 10pt">&#160;</p>

<p style="margin: 0; font-size: 10pt; text-align: center">Date of Report (Date of earliest event reported):&#160;<span id="xdx_900_edei--DocumentPeriodEndDate_c20250909__20250909_z2FkD5HM1yMc"><ix:nonNumeric contextRef="AsOf2025-09-09" format="ixt:datemonthdayyearen" id="Fact000010" name="dei:DocumentPeriodEndDate">September 9, 2025</ix:nonNumeric></span></p>

<p style="margin: 0; font-size: 10pt">&#160;</p>

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<p style="margin: 0; font-size: 10pt; text-align: center">(Exact name of registrant as specified in its charter)</p>

<p style="margin: 0 0 5pt; font-size: 10pt">&#160;</p>

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<p style="margin: 0; font-size: 10pt">&#160;</p>

<p style="margin: 0; font-size: 10pt">&#160;</p>

<p style="margin: 0; font-size: 10pt; text-align: center">(Former name or former address, if changed since last report.)</p>

<p style="margin: 0; font-size: 10pt">&#160;</p>

<p style="margin: 0 0 5pt; font-size: 10pt">Check the appropriate box below if the Form&#160;8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following provisions:</p>

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    <td>&#160;</td></tr>
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    <td><span style="font-size: 10pt">Pre-commencement communications pursuant to Rule&#160;14d-2(b)&#160;under the Exchange Act (17 CFR 240.14d-2(b))</span></td></tr>
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    <td><span style="font-size: 10pt">Pre-commencement communications pursuant to Rule&#160;13e-4(c)&#160;under the Exchange Act (17 CFR 240.13e-4(c))</span></td></tr>
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<p style="margin: 5pt 0 0; font-size: 10pt">&#160;</p>

<p style="margin: 0; font-size: 10pt">Securities registered pursuant to Section&#160;12(b)&#160;of the Act:</p>

<p style="margin: 0 0 5pt; font-size: 10pt">&#160;</p>

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<p style="margin: 5pt 0 0; font-size: 10pt">&#160;</p>

<p style="margin: 0; font-size: 10pt">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule&#160;405
of the Securities Act of 1933 (&#167;230.405 of this chapter) or Rule&#160;12b-2 of the Securities Exchange Act of 1934 (&#167;240.12b-2
of this chapter).&#160;</p>

<p style="margin: 0; font-size: 10pt; text-align: right">Emerging growth company&#160;<span style="font-family: Wingdings"><span id="xdx_900_edei--EntityEmergingGrowthCompany_c20250909__20250909_zd5xBtPDwi5f"><ix:nonNumeric contextRef="AsOf2025-09-09" format="ixt:booleanfalse" id="Fact000028" name="dei:EntityEmergingGrowthCompany">&#9744;</ix:nonNumeric></span></span></p>

<p style="margin: 0; font-size: 10pt; text-align: right">&#160;</p>

<p style="margin: 0; font-size: 10pt">If an emerging growth company, indicate by check mark if the registrant has elected not to use the
extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section&#160;13(a)&#160;of
the Exchange Act.&#160;&#160;&#160;<span style="font-family: Wingdings">o</span></p>

<p style="margin: 0; font-size: 10pt">&#160;</p>

<p style="margin: 0; font-size: 10pt; text-align: justify"><b></b></p>

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<p style="margin: 0; font-size: 10pt; text-align: justify"><b>Item 8.01. Other Events.</b></p>

<p style="margin: 0; font-size: 10pt; text-align: justify"><b>&#160;</b></p>

<p style="margin: 0; font-size: 10pt; text-align: justify">On September 9, 2025, the U.S. District Court for the District of New Jersey
issued a claim construction ruling in the lawsuit brought by Arbutus Biopharma Corporation and its licensee Genevant Sciences against
Pfizer Inc. and BioNTech SE (Pfizer/BioNTech) seeking damages for infringement of U.S. Patent Nos. 9,504,561, 8,492,359, 11,141,378, 11,298,320
and 11,318,098 in the manufacture and sale of Pfizer/BioNTech&#8217;s COVID-19 mRNA-based vaccines. A copy of the Court&#8217;s claim
construction order and opinion is filed herewith as Exhibit 99.1 and is incorporated by reference herein.</p>

<p style="margin: 0; font-size: 10pt; text-align: justify">&#160;</p>

<p style="margin: 0; font-size: 10pt"><b>Item 9.01. Financial Statements and Exhibits.</b></p>

<p style="margin: 0; font-size: 10pt">&#160;</p>

<p style="margin: 0; font-size: 10pt"><b>(d)&#160;Exhibits.</b></p>

<p style="margin: 0 0 5pt; font-size: 10pt">&#160;</p>

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    <td style="width: 1%; text-align: center">&#160;</td>
    <td style="border-bottom: black 1pt solid; width: 84%; text-align: center"><span style="font-size: 10pt"><b>Description</b></span></td></tr>
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    <td><span style="font-size: 10pt"><a href="exh_991.htm">99.1</a></span></td>
    <td>&#160;</td>
    <td><span style="font-size: 10pt"><a href="exh_991.htm">Claim Construction Order and Opinion, dated September 9, 2025</a></span></td></tr>
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    <td><span style="font-size: 10pt">104</span></td>
    <td>&#160;</td>
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<p style="margin: 5pt 0 0; font-size: 10pt">&#160;</p>

<p style="margin: 5pt 0 0; font-size: 10pt">&#160;</p>

<p style="margin: 0; font-size: 10pt; text-align: center"></p>

<!-- Field: Page; Sequence: 2 -->
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<p style="margin: 0; font-size: 10pt; text-align: center"><b>SIGNATURE</b></p>

<p style="margin: 0; font-size: 10pt">&#160;</p>

<p style="margin: 0; font-size: 10pt; text-indent: 27pt">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</p>

<p style="margin: 0; font-size: 10pt">&#160;</p>

<p style="margin: 0 0 5pt; font-size: 10pt">&#160;</p>

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    <td>&#160;</td>
    <td colspan="2"><span style="font-size: 10pt"><b>Arbutus Biopharma Corporation</b></span></td></tr>
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    <td>&#160;</td>
    <td colspan="2">&#160;</td></tr>
  <tr style="vertical-align: bottom">
    <td style="width: 43%"><span style="font-size: 10pt">Date: September 10, 2025</span></td>
    <td style="width: 8%"><span style="font-size: 10pt">By:</span></td>
    <td style="border-bottom: black 1pt solid; width: 49%"><span style="font-size: 10pt">/s/ Tuan Nguyen</span></td></tr>
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    <td>&#160;</td>
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  <tr style="vertical-align: bottom">
    <td>&#160;</td>
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<p style="margin: 5pt 0 0; font-size: 10pt">&#160;</p>

<p style="margin: 5pt 0 0; font-size: 10pt">&#160;</p>

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exh_991.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
<HTML>
<HEAD>
     <TITLE></TITLE>
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<BODY STYLE="font: 10pt Times New Roman, Times, Serif">

<P STYLE="text-align: right; margin: 0"><B>Exhibit 99.1</B></P>

<P STYLE="margin: 0; text-align: right">&nbsp;</P>

<TABLE BORDER="0" CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: middle">
    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 247</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 1 of 1</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6979&nbsp; </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
  </TABLE>

<P STYLE="font-size: 10pt; margin: 0.6pt 0 0 1pt; color: blue"></P>

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="text-align: center; font-size: 10pt; font-weight: bold; margin-top: 4pt; margin-bottom: 0; color: #0C0C0C"><FONT STYLE="letter-spacing: -0.05pt">UNITED
STATES</FONT> DISTRICT COURT <BR>
DISTRICT OF NEW JERSEY</P>

<P STYLE="font-size: 10pt; margin: 0"><B></B></P>

<P STYLE="font-size: 10pt; margin: 0"><B>&nbsp;</B></P>

<TABLE BORDER="0" CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; border-collapse: collapse; font-size: 10pt">
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; border-top: Black 1pt solid; width: 50%">&nbsp;</TD>
    <TD STYLE="width: 50%">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; color: #0C0C0C; font-weight: bold; text-align: center">ARBUTUS PHARMA CORP., <FONT STYLE="font-size: 10pt; font-weight: 700; color: #0C0C0C"><I>et al.,</I></FONT></TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; font-weight: bold; font-style: italic; text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; color: #0C0C0C; text-align: center">Plaintiffs,</TD>
    <TD STYLE="padding-left: 10pt; text-align: left">Civil</FONT> <FONT STYLE="color: #1C1C1C">Action</FONT>
<FONT STYLE="color: #0C0C0C">No. 3</FONT><FONT STYLE="color: #1C1C1C">:23-cv-1876-ZNQ-TJB</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; color: #1C1C1C; text-align: center">v.</TD>
    <TD STYLE="padding-left: 10pt; text-align: left"><B>CLAIM CONSTRUCTION ORDER</B></TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; color: #0C0C0C; font-weight: bold; text-align: center">PFIZER, INC., <FONT STYLE="font-size: 10pt; font-weight: 700; color: #0C0C0C"><I>et al.,</I></FONT></TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; font-weight: bold; font-style: italic; text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; color: #0C0C0C; text-align: center">Defendants.</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; color: #0C0C0C; text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  </TABLE>
<P STYLE="margin: 0; font-size: 10pt"><B></B></P>

<P STYLE="font-size: 10pt; margin: 0"><B></B></P>

<P STYLE="font-size: 10pt; margin: 0 0 0 260.15pt"></P>

<P STYLE="font-size: 10pt; margin: 0"><B>&nbsp;</B></P>

<P STYLE="font-size: 10pt; margin: 0 0 0 7.5pt; color: #0C0C0C"><B>QURAISHI, District Judge</B></P>

<P STYLE="font-size: 10pt; margin: 0.35pt 0 0"><B>&nbsp;</B></P>

<P STYLE="font-size: 10pt; text-indent: 35.8pt; margin: 0 0 0 7.3pt"><FONT STYLE="color: #0C0C0C">For the reasons set forth in the</FONT>
<FONT STYLE="color: #1C1C1C">accompanying</FONT> <FONT STYLE="color: #0C0C0C">Opinion, the Court hereby construes the parties&rsquo; disputed
terms as set forth below</FONT></P>

<P STYLE="margin: 0 0 0 7.3pt; font-size: 10pt; text-indent: 35.8pt"><FONT STYLE="color: #0C0C0C"></FONT><FONT STYLE="color: #2B2B2B">.</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="2" STYLE="width: 100%; font-size: 10pt; border-collapse: collapse">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 38%; border: black 1pt solid; padding-left: 71.2pt; text-align: center; font-size: 10pt"><FONT STYLE="font-size: 10pt; color: #0C0C0C"><B>TERM</B></FONT></TD>
    <TD STYLE="width: 62%; border-top: black 1pt solid; border-right: black 1pt solid; border-bottom: black 1pt solid; padding-left: 67.05pt; font-size: 10pt"><FONT STYLE="font-size: 10pt; color: #0C0C0C"><B>COURT&rsquo;S CONSTRUCTION</B></FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid; border-left: black 1pt solid; padding-left: 5.7pt; font-size: 10pt"><FONT STYLE="font-size: 10pt; color: #1C1C1C">&ldquo;lipid</FONT> <FONT STYLE="font-size: 10pt; color: #0C0C0C">vesicle&rdquo;</FONT></TD>
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid">
    <P STYLE="font-size: 10pt; text-indent: -0.15pt; margin: 1pt 2.15pt 0 5.8pt"><FONT STYLE="color: #0C0C0C">&ldquo;any lipid composition
that can be used to deliver a compound including, but not limited to, liposomes</FONT><FONT STYLE="color: #2B2B2B">,</FONT> <FONT STYLE="color: #0C0C0C">wherein
an aqueous volume is encapsulated by an amphipathic lipid bilayer; or wherein the lipids coat an interior comprising a large molecular
component, such as a plasmid, with a reduced aqueous interior</FONT><FONT STYLE="color: #2B2B2B">; </FONT><FONT STYLE="color: #0C0C0C">or
</FONT><FONT STYLE="color: #1C1C1C">lipid</FONT> <FONT STYLE="color: #0C0C0C">aggregates or micelles, wherein the encapsulated component
is contained within a relatively disordered lipid mixture&rdquo;</FONT></P></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid; border-left: black 1pt solid; padding-left: 5.25pt; font-size: 10pt"><FONT STYLE="font-size: 10pt; color: #1C1C1C">&ldquo;fully </FONT><FONT STYLE="font-size: 10pt; color: #0C0C0C">encapsulated&rdquo;</FONT></TD>
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid; font-size: 10pt"><FONT STYLE="font-size: 10pt; color: #1C1C1C">&ldquo;contained</FONT> <FONT STYLE="font-size: 10pt; color: #0C0C0C">inside</FONT><FONT STYLE="font-size: 10pt; color: #2B2B2B">&rdquo;</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid; border-left: black 1pt solid; padding-left: 5.25pt; font-size: 10pt"><FONT STYLE="font-size: 10pt; color: #2B2B2B">&ldquo;</FONT><FONT STYLE="font-size: 10pt; color: #0C0C0C">mol %&rdquo;</FONT></TD>
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid">
    <P STYLE="font-size: 10pt; text-indent: -0.4pt; margin: 1pt 0 0 5.6pt"><FONT STYLE="color: #1C1C1C">&ldquo;the</FONT> <FONT STYLE="color: #0C0C0C">recited
    mol % ranges are understood to encompass their standard variation based on the significant figures recited in the claim</FONT><FONT STYLE="color: #2B2B2B">&rdquo;</FONT></P></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid; border-left: black 1pt solid; padding-left: 5.25pt; font-size: 10pt"><FONT STYLE="font-size: 10pt; color: #1C1C1C">&ldquo;consisting</FONT> <FONT STYLE="font-size: 10pt; color: #0C0C0C">essentially of&rdquo;</FONT></TD>
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid">
    <P STYLE="font-size: 10pt; text-indent: -0.1pt; margin: 0.75pt 16.05pt 0 5.3pt"><FONT STYLE="color: #1C1C1C">&ldquo;consisting </FONT><FONT STYLE="color: #0C0C0C">of
    only the listed ingredients and those that do not materially affect the increased </FONT><FONT STYLE="color: #1C1C1C">activity </FONT><FONT STYLE="color: #0C0C0C">of
    the <FONT STYLE="letter-spacing: -0.05pt">encapsulated nucleic</FONT> acid and the improved tolerability of the formulations in
    vivo, or the stability in circulation&rdquo;</FONT></P></TD></TR>
  </TABLE>
<P STYLE="font-size: 10pt; margin: 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0"></P>

<P STYLE="margin: 0; font-size: 10pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="border-collapse: collapse; font: 10pt Times New Roman, Times, Serif; width: 100%">
<TR STYLE="vertical-align: top; text-align: left">
  <TD STYLE="width: 50%"><FONT STYLE="font-size: 10pt; color: #0C0C0C"><B>DATED</B></FONT><B> <FONT STYLE="font-size: 10pt; color: #2B2B2B">:</FONT></B>
<FONT STYLE="font-size: 10pt; color: #0C0C0C">September 9, 2025</TD>
  <TD STYLE="width: 50%">&nbsp;<IMG SRC="sign.jpg" ALT=""></TD></TR>
</TABLE>

<P STYLE="margin: 0; font-size: 10pt"></P>

<P STYLE="margin: 0; font-size: 10pt"></P>

<P STYLE="font-size: 10pt; margin: 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0.2pt 0 0">&nbsp;</P>

<P STYLE="font-size: 10pt; font-weight: bold; margin: 4.55pt 0 0 7.35pt; color: #0C0C0C"></P>

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    <!-- Field: /Page -->

<TABLE BORDER="0" CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: middle">
    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 1 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
<TR STYLE="vertical-align: middle">
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6952&nbsp; </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
</TABLE>

<P STYLE="margin: 4.55pt 0 0 7.35pt; font-size: 10pt; font-weight: bold; color: #0C0C0C">&nbsp;</P>

<P STYLE="margin: 4.55pt 0 0 7.35pt; font-size: 10pt; font-weight: bold; color: #0C0C0C">*NOT FOR PUBLICATION*</P>

<P STYLE="font-size: 10pt; margin: 0.35pt 0 0"><B>&nbsp;</B></P>

<P STYLE="text-align: center; font-size: 10pt; margin-top: 0; margin-bottom: 0; color: #0C0C0C"><FONT STYLE="letter-spacing: -0.05pt"><B>UNITED
STATES</B></FONT><B> DISTRICT COURT <BR>
DISTRICT OF NEW JERSEY</B></P>

<P STYLE="font-size: 10pt; margin: 0"><B>&nbsp;</B></P>

<P STYLE="font-size: 10pt; margin: 0"><B>&nbsp;</B></P>

<TABLE BORDER="0" CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; border-collapse: collapse; font-size: 10pt">
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; border-top: Black 1pt solid; width: 50%">&nbsp;</TD>
    <TD STYLE="width: 50%">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; color: #0C0C0C; font-weight: bold; text-align: center">ARBUTUS PHARMA CORP., <FONT STYLE="font-size: 10pt; font-weight: 700; color: #0C0C0C"><I>et al.,</I></FONT></TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; font-weight: bold; font-style: italic; text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; color: #0C0C0C; text-align: center">Plaintiffs,</TD>
    <TD STYLE="padding-left: 10pt">Civil Action No. 3:23-cv</FONT><FONT STYLE="color: #313131">-</FONT><FONT STYLE="color: #0C0C0C">1876-ZNQ-TJB</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; font-size: 12pt; text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; color: #212121; text-align: center">V.</TD>
    <TD STYLE="padding-left: 10pt"><B>CLAIM CONSTRUCTION OPINION</B></TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; color: #0C0C0C; font-weight: bold; text-align: center">PFIZER, INC., <FONT STYLE="font-size: 10pt; font-weight: 700; color: #0C0C0C"><I>et al.,</I></FONT></TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; font-weight: bold; font-style: italic; text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; color: #0C0C0C; text-align: center">Defendants.</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: middle">
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; color: #0C0C0C; text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  </TABLE>
<P STYLE="margin: 0; font-size: 10pt"><B></B></P>

<P STYLE="font-size: 10pt; margin: 0"><B>&nbsp;</B></P>

<P STYLE="margin: 0; font-size: 10pt"><B></B></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 6.3pt; color: #0C0C0C"><B>QURAISHI, District Judge</B></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 6.3pt; color: #0C0C0C">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B></B></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.4pt; margin: 0pt 12.8pt 0pt 5.85pt"><FONT STYLE="color: #0C0C0C">In this
Opinion</FONT><FONT STYLE="color: #313131">, </FONT><FONT STYLE="color: #0C0C0C">the Court construes claim terms from five patents directed
to compositions and methods for preparing lipid nanoparticles containing therapeutic agents. The parties submitted the following briefs
in support of their respective positions: Defendants&rsquo; Opening Brief (ECF No. 83); Plaintiffs&rsquo; Opening Brief (ECF No. 84);
Defendants&rsquo; Response Brief (ECF No. 135); and Plaintiffs&rsquo; Response Brief (ECF No. 136). After reviewing the parties&rsquo;
submissions and conducting a <I>Markman </I>hearing on the record on December 18, 2024, the Court construes the parties&rsquo; four disputed
terms as set forth herein.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.4pt; margin: 0pt 12.8pt 0pt 5.85pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-bottom: 0pt; color: #0C0C0C"><TR STYLE="vertical-align: top">
<TD STYLE="width: 5.75pt"></TD><TD STYLE="width: 36.05pt"><FONT STYLE="letter-spacing: -0.05pt">I.</FONT></TD><TD>PROCEDURAL HISTORY</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B></B></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.1pt; margin: 0pt 13.2pt 0pt 5.55pt"><FONT STYLE="color: #0C0C0C">Plaintiffs
Arbutus Pharma Corp. and Genevant Sciences GmbH (collectively, </FONT><FONT STYLE="color: #212121">&ldquo;Plaintiffs&rdquo;)</FONT> <FONT STYLE="color: #0C0C0C">brought
this patent infringement suit against Defendants Pfizer, Inc., and BioNTech SE. (collectively, </FONT><FONT STYLE="color: #212121">&ldquo;Defendants&rdquo;)
</FONT><FONT STYLE="color: #0C0C0C">for infringement of United States Patent Nos. 9</FONT><FONT STYLE="color: #313131">,</FONT><FONT STYLE="color: #0C0C0C">504,651
(&ldquo;the </FONT><FONT STYLE="color: #212121">&lsquo;651</FONT> <FONT STYLE="color: #0C0C0C">Patent&rdquo;), 8,492,359 (&ldquo;the &lsquo;359
Patent&rdquo;), 11,141,378 (&ldquo;the</FONT> <FONT STYLE="color: #313131">&lsquo;</FONT><FONT STYLE="color: #0C0C0C">378 Patent&rdquo;),
11,298,320 (&ldquo;the &lsquo;320 Patent&rdquo;)</FONT><FONT STYLE="color: #313131">,</FONT> <FONT STYLE="color: #0C0C0C">and 11,318,098
(&ldquo;the &lsquo;098 Patent&rdquo;) (collectively, &ldquo;the patents in suit&rdquo;). <I>See generally</I></FONT></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 5.6pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><I></I></P>

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<TR STYLE="vertical-align: middle">
    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 2 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
<TR STYLE="vertical-align: middle">
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6953&nbsp; </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
</TABLE></P>

<P STYLE="margin: 0pt 0; font-size: 10pt"><I>&nbsp;</I></P>

<P STYLE="margin: 0pt 0; font-size: 10pt"><I>&nbsp;</I></P>

<P STYLE="font-size: 10pt; text-indent: 0.15pt; margin: 0pt 13pt 0pt 7.6pt"><FONT STYLE="color: #0F0F0F">Complaint (ECF No. 1.) Defendants
answered the Complaint. The parties are currently engaged in discovery. (ECF Nos. 33</FONT><FONT STYLE="color: #383838">, </FONT><FONT STYLE="color: #0F0F0F">148)</FONT><FONT STYLE="color: #383838">.</FONT></P>

<P STYLE="font-size: 10pt; text-indent: 0.15pt; margin: 0pt 13pt 0pt 7.6pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top">
<TD STYLE="width: 7.45pt"></TD><TD STYLE="width: 36.05pt"><FONT STYLE="letter-spacing: -0.05pt">II.</FONT></TD><TD>FACTUAL BACKGROUND</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B></B></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.05pt; margin: 0pt 11.3pt 0pt 7.3pt"><FONT STYLE="color: #0F0F0F">By design,
the inside of a human body is a hostile place. Our bloodstreams contain a series of enzymes that digest various proteins and nucleic acids</FONT><FONT STYLE="color: #383838">.</FONT>
<FONT STYLE="color: #0F0F0F">This poses certain well-known challenges to medical science: therapeutics vulnerable to these enzymes survive
only briefly in a patient&rsquo;s blood stream after they are administered by injection.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.05pt; margin: 0pt 11.3pt 0pt 7.3pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.25pt; margin: 0pt 11.55pt 0pt 6.75pt"><FONT STYLE="color: #0F0F0F">In
succinct terms, the inventors of the patents in suit address this problem by tucking a vulnerable therapeutic inside nanoscopic particles
of fat with a particular structure-referred to as &ldquo;liposomes&rdquo; or </FONT><FONT STYLE="color: #232323">&ldquo;lipid </FONT><FONT STYLE="color: #0F0F0F">nanoparticles&rdquo;
or </FONT><FONT STYLE="color: #232323">&ldquo;lipid </FONT><FONT STYLE="color: #0F0F0F">vesicles.&rdquo; Inside these structures, the
therapeutics are shielded from enzymatic digestion.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.25pt; margin: 0pt 11.55pt 0pt 6.75pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.05pt; margin: 0pt 11.75pt 0pt 6.8pt; color: #0F0F0F">Messenger ribonucleic
acid (mRNA) is an example of a vulnerable therapeutic when it is administered to patients to treat a disease or disorder. It is well-known
that mRNA figured prominently in the world&rsquo;s response to COVID-19. Notably, it formed the basis of Defendants&rsquo; COMIRNATY&reg;
COVID-19 vaccine. The Complaint in this case accuses Defendants of infringing the patents in suit by using Plaintiffs&rsquo; liposome
technology in Defendants&rsquo; vaccine without Plaintiffs&rsquo; permission.</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.05pt; margin: 0pt 11.75pt 0pt 6.8pt; color: #0F0F0F">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.15pt; margin: 0pt 11.75pt 0pt 6.55pt"><FONT STYLE="color: #0F0F0F">At
this stage of the proceedings</FONT><FONT STYLE="color: #383838">,</FONT> <FONT STYLE="color: #0F0F0F">the Court is called upon to construe
disputed terms in the patents&rsquo; claims. The four disputed claim terms are: (1) &ldquo;lipid vesicle,&rdquo; (2)</FONT> <FONT STYLE="color: #232323">&ldquo;fully</FONT>
<FONT STYLE="color: #0F0F0F">encapsulated,&rdquo; <FONT STYLE="letter-spacing: -0.05pt">(3)</FONT></FONT> <FONT STYLE="color: #232323; letter-spacing: -0.05pt">&ldquo;mol</FONT>
<FONT STYLE="color: #0F0F0F; letter-spacing: -0.05pt">%,&rdquo; and (4)</FONT> <FONT STYLE="color: #232323; letter-spacing: -0.05pt">&ldquo;consisting</FONT>
<FONT STYLE="color: #0F0F0F">essentially of.&rdquo;</FONT></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 6.55pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top">
<TD STYLE="width: 6.45pt"></TD><TD STYLE="width: 35.9pt"><FONT STYLE="letter-spacing: -0.05pt">III.</FONT></TD><TD>LEGAL STANDARD</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B></B></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.85pt; margin: 0pt 10pt 0pt 6.4pt; color: #0F0F0F">A patent infringement
case typically involves two steps: construing the claims and determining whether the accused product infringes the claims. <FONT STYLE="font-size: 10pt"><I>See
Markman v. Westview</I></FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.85pt; margin: 0pt 10pt 0pt 6.4pt; color: #0F0F0F">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><I></I></P>

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    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6954 </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
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<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><I></I></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.35pt; margin: 0pt 10.95pt 0pt 7.7pt"><FONT STYLE="color: #0F0F0F"><I>Instruments</I></FONT><I><FONT STYLE="color: #2A2A2A">,</FONT>
<FONT STYLE="color: #0F0F0F">Inc., </FONT></I><FONT STYLE="color: #0F0F0F">52 F</FONT><FONT STYLE="color: #4B4B4B">.</FONT><FONT STYLE="color: #0F0F0F">3d
967, 976 (Fed. Cir. 1995) (en banc), <I>aff&rsquo;d</I></FONT><I><FONT STYLE="color: #2A2A2A">, </FONT></I><FONT STYLE="color: #0F0F0F">517
U.S. 370 (1996); <I>Hormone Research Found., Inc</I></FONT><I><FONT STYLE="color: #5D5D5D">. </FONT><FONT STYLE="color: #0F0F0F">v</FONT><FONT STYLE="color: #4B4B4B">.
</FONT><FONT STYLE="color: #0F0F0F">Genentech, Inc.</FONT><FONT STYLE="color: #2A2A2A">, </FONT></I><FONT STYLE="color: #0F0F0F">904 F</FONT><FONT STYLE="color: #2A2A2A">.</FONT><FONT STYLE="color: #0F0F0F">2d
1558</FONT><FONT STYLE="color: #2A2A2A">, </FONT><FONT STYLE="color: #0F0F0F">1562 (Fed. Cir. 1990), <I>cert. dismissed</I></FONT><I><FONT STYLE="color: #2A2A2A">,</FONT></I>
<FONT STYLE="color: #0F0F0F">499 U</FONT><FONT STYLE="color: #2A2A2A">.</FONT><FONT STYLE="color: #0F0F0F">S. 955 (1991).</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.35pt; margin: 0pt 10.95pt 0pt 7.7pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-indent: 36.45pt; margin: 0pt 5.2pt 0pt 7.4pt"><FONT STYLE="color: #0F0F0F">Claim construction is primarily
a question of law. <I>See Teva Pharm</I></FONT><I><FONT STYLE="color: #4B4B4B">.</FONT> <FONT STYLE="color: #0F0F0F">U S.A</FONT><FONT STYLE="color: #2A2A2A">.</FONT><FONT STYLE="color: #0F0F0F">,
Inc</FONT><FONT STYLE="color: #5D5D5D">.</FONT> <FONT STYLE="color: #0F0F0F">v</FONT><FONT STYLE="color: #4B4B4B">.</FONT> <FONT STYLE="color: #0F0F0F">Sandoz</FONT><FONT STYLE="color: #2A2A2A">,</FONT>
<FONT STYLE="color: #0F0F0F">Inc</FONT><FONT STYLE="color: #2A2A2A">.,</FONT></I> <FONT STYLE="color: #0F0F0F">574 U.S. 318, 325-26 (2015).
It begins with the claim language. <I>Innova</I></FONT><I><FONT STYLE="color: #2A2A2A">/</FONT><FONT STYLE="color: #0F0F0F">Pure Water</FONT><FONT STYLE="color: #2A2A2A">,</FONT>
<FONT STYLE="color: #0F0F0F">Inc. v. Safari Wat</FONT><FONT STYLE="color: #2A2A2A">e</FONT><FONT STYLE="color: #0F0F0F">r Filtration Sys.,
Inc.,</FONT></I><FONT STYLE="color: #0F0F0F"> 381 F.3d 1111, 1115 (Fed. Cir. 2004)</FONT><FONT STYLE="color: #2A2A2A">;</FONT> <FONT STYLE="color: #0F0F0F"><I>Markman,</I>
52 F.3d at 980</FONT><FONT STYLE="color: #2A2A2A">.</FONT> <FONT STYLE="color: #0F0F0F">Claim language is generally &ldquo;given [its]
ordinary and customary meaning.</FONT><FONT STYLE="color: #2A2A2A">&rdquo;</FONT> <FONT STYLE="color: #0F0F0F"><I>Vitronics Corp. v. Conceptronic,
Inc.</I></FONT><I><FONT STYLE="color: #2A2A2A">, </FONT></I><FONT STYLE="color: #0F0F0F">90 F</FONT><FONT STYLE="color: #2A2A2A">.</FONT><FONT STYLE="color: #0F0F0F">3d
1576</FONT><FONT STYLE="color: #2A2A2A">,</FONT> <FONT STYLE="color: #0F0F0F">1582 (Fed. Cir. 1996) (</FONT><FONT STYLE="color: #2A2A2A">&ldquo;</FONT><FONT STYLE="color: #0F0F0F">[W]e
look to the words of the claims themselves . </FONT><FONT STYLE="color: #2A2A2A">. </FONT><FONT STYLE="color: #0F0F0F">. to define the
scope of the patented invention</FONT><FONT STYLE="color: #2A2A2A">.</FONT><FONT STYLE="color: #0F0F0F">&rdquo;)</FONT><FONT STYLE="color: #2A2A2A">;
</FONT><FONT STYLE="color: #0F0F0F"><I>see also Interactive Gift Express</I></FONT><I><FONT STYLE="color: #2A2A2A">,</FONT> <FONT STYLE="color: #0F0F0F">Inc</FONT><FONT STYLE="color: #4B4B4B">.</FONT>
<FONT STYLE="color: #0F0F0F">v. Compuserve</FONT><FONT STYLE="color: #2A2A2A">,</FONT> <FONT STYLE="color: #0F0F0F">Inc</FONT><FONT STYLE="color: #4B4B4B">.</FONT><FONT STYLE="color: #0F0F0F">,</FONT></I><FONT STYLE="color: #0F0F0F">
256 F.3d 1323, 1331 (Fed. Cir. 2001) (&ldquo;In construing claims, the analytical focus must begin and remain centered on the language
of the claims themselves, for it</FONT> <FONT STYLE="color: #A5A5A5">.</FONT> <FONT STYLE="color: #0F0F0F">is that language that the patentee
chose to use to &lsquo;particularly point [] out and distinctly claim[] the subject matter which the patentee regards as his invention.&rsquo;&rdquo;)
(quoting 35 U.S</FONT><FONT STYLE="color: #2A2A2A">.</FONT><FONT STYLE="color: #0F0F0F">C</FONT><FONT STYLE="color: #4B4B4B">. </FONT><FONT STYLE="color: #0F0F0F">&sect;
112). Ordinary meaning is determined by &ldquo;a person of ordinary skill in the art in question at the time of the invention.&rdquo;<SUP>1</SUP>
<I>Phillips v. AHW Corp.</I></FONT><I><FONT STYLE="color: #2A2A2A">, </FONT></I><FONT STYLE="color: #0F0F0F">415 F</FONT><FONT STYLE="color: #4B4B4B">.</FONT><FONT STYLE="color: #0F0F0F">3d
1303</FONT><FONT STYLE="color: #2A2A2A">,</FONT> <FONT STYLE="color: #0F0F0F">1313 (Fed</FONT><FONT STYLE="color: #2A2A2A">.</FONT> <FONT STYLE="color: #0F0F0F">Cir.
2005) (collecting cases); <I>Brookhill-Wilk 1, LLC v</I></FONT><I><FONT STYLE="color: #2A2A2A">.</FONT> <FONT STYLE="color: #0F0F0F">Intuitive
Surgical</FONT><FONT STYLE="color: #2A2A2A">,</FONT> <FONT STYLE="color: #0F0F0F">Inc</FONT><FONT STYLE="color: #2A2A2A">.</FONT><FONT STYLE="color: #0F0F0F">,</FONT></I><FONT STYLE="color: #0F0F0F">
334 F</FONT><FONT STYLE="color: #2A2A2A">.</FONT><FONT STYLE="color: #0F0F0F">3d 1294, 1298 (Fed</FONT><FONT STYLE="color: #2A2A2A">.</FONT>
<FONT STYLE="color: #0F0F0F">Cir. 2003)</FONT><FONT STYLE="color: #2A2A2A">.</FONT> <FONT STYLE="color: #0F0F0F">However</FONT><FONT STYLE="color: #2A2A2A">,</FONT>
<FONT STYLE="color: #0F0F0F">if a patentee has used the claim language in some manner other than its ordinary meaning, as indicated by
the balance of intrinsic evidence, such as the specification, then that meaning controls. <I>See, e.g.</I></FONT><I><FONT STYLE="color: #2A2A2A">,
</FONT><FONT STYLE="color: #0F0F0F">Phillips, </FONT></I><FONT STYLE="color: #0F0F0F">415 F.3d at 1226; <I>Ecolab</I></FONT><I><FONT STYLE="color: #2A2A2A">,
</FONT><FONT STYLE="color: #0F0F0F">Inc. v. Envirochem</FONT><FONT STYLE="color: #2A2A2A">, </FONT><FONT STYLE="color: #0F0F0F">Inc</FONT><FONT STYLE="color: #4B4B4B">.</FONT><FONT STYLE="color: #0F0F0F">,
</FONT></I><FONT STYLE="color: #0F0F0F">264 F.3d 1358, 1366 (Fed</FONT><FONT STYLE="color: #2A2A2A">.</FONT> <FONT STYLE="color: #0F0F0F">Cir.
2001)</FONT><FONT STYLE="color: #2A2A2A">;</FONT> <FONT STYLE="color: #0F0F0F"><I>Allen Engineering Corp</I></FONT><I><FONT STYLE="color: #2A2A2A">.</FONT>
<FONT STYLE="color: #0F0F0F">v</FONT><FONT STYLE="color: #4B4B4B">.</FONT> <FONT STYLE="color: #0F0F0F">Bartell Industries, Inc.</FONT><FONT STYLE="color: #2A2A2A">,</FONT></I>
<FONT STYLE="color: #0F0F0F">299 F.3d 1336</FONT><FONT STYLE="color: #2A2A2A">,</FONT> <FONT STYLE="color: #0F0F0F">1344 (Fed. Cir.</FONT></P>

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<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="margin: 0pt 12.15pt 0pt 7.35pt; font-size: 10pt; text-align: justify; text-indent: 1.1pt">____________________</P>

<P STYLE="margin: 0pt 12.15pt 0pt 7.35pt; font-size: 10pt; text-align: justify; text-indent: 1.1pt"></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 1.1pt; margin: 0pt 12.15pt 0pt 7.35pt"><FONT STYLE="font-size: 9pt; color: #0F0F0F"><SUP>1</SUP>
The parties disagree on the proper definition of a person of ordinary skill in the art</FONT><FONT STYLE="font-size: 9pt; color: #2A2A2A">,
</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">but concede that the Court need not decide that issue for the purpose of resolving
their present claim construction dispute. <I>Se</I></FONT><I><FONT STYLE="font-size: 9pt; color: #2A2A2A">e </FONT></I><FONT STYLE="font-size: 9pt; color: #0F0F0F">Markman
Tr.</FONT><FONT STYLE="font-size: 9pt; color: #2A2A2A">, </FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">at 23:8</FONT><FONT STYLE="font-size: 9pt; color: #4B4B4B">-</FONT>
<FONT STYLE="font-size: 9pt; color: #0F0F0F">12</FONT><FONT STYLE="font-size: 9pt; color: #2A2A2A">, </FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">ECF
No</FONT><FONT STYLE="font-size: 9pt; color: #5D5D5D">.</FONT> <FONT STYLE="font-size: 9pt; color: #0F0F0F">159.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 1.1pt; margin: 0pt 12.15pt 0pt 7.35pt"><FONT STYLE="font-size: 9pt">&nbsp;</FONT></P>

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    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 4 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6955&nbsp; </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
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<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.15pt; margin: 0pt 10.7pt 0pt 7.8pt; color: #0F0F0F">2002) <FONT STYLE="font-size: 10pt">(&ldquo;It
</FONT>is thus necessary to review [intrinsic evidence] to determine whether the patentee has assigned any special meaning to claim terms.&rdquo;).</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.15pt; margin: 0pt 10.7pt 0pt 7.8pt; color: #0F0F0F">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.5in; margin: 0pt 10.7pt 0pt 7.55pt"><FONT STYLE="color: #0F0F0F">Because
&ldquo;there is no magic formula or catechism&rdquo; for determining ordinary meaning, nor a </FONT><FONT STYLE="color: #262626">&ldquo;rigid
</FONT><FONT STYLE="color: #0F0F0F">algorithm&rdquo; or </FONT><FONT STYLE="color: #262626">&ldquo;specific </FONT><FONT STYLE="color: #0F0F0F">sequence,&rdquo;
<I>Phillips, </I>415 F.3d at 1324, a court must read claims in context. <I>See Medrad Inc</I></FONT><I><FONT STYLE="color: #3F3F3F">.
</FONT><FONT STYLE="color: #0F0F0F">v. MRI Devices Corp., </FONT></I><FONT STYLE="color: #0F0F0F">401 F.3d 1313, 1319 (Fed. Cir. 2005)
(&ldquo;We cannot look at the ordinary meaning of the term ... in a vacuum.&rdquo;); <I>see also DeMarini Sports, Inc. <FONT STYLE="font-size: 10pt">v.
Worth, </FONT>239 F.3d 1314, 1324 (Fed. Cir. 2001). To this end, a court must consider </I></FONT><I><FONT STYLE="color: #262626">&ldquo;the
</FONT><FONT STYLE="color: #0F0F0F">written description and prosecution history,&rdquo; <FONT STYLE="font-size: 10pt">Medrad</FONT></FONT><FONT STYLE="font-size: 10pt; color: #3F3F3F">,
</FONT><FONT STYLE="color: #0F0F0F">401 F.3d at 1319, </FONT><FONT STYLE="color: #262626">&ldquo;the </FONT><FONT STYLE="color: #0F0F0F">specification,&rdquo;
<FONT STYLE="font-size: 10pt">Phillips, </FONT>415 F.3d at 1313, which is &ldquo;always highly relevant to the claim construction analysis,&rdquo;
<FONT STYLE="font-size: 10pt">Vitronics, </FONT>90 F.3d at 1582, because it </FONT><FONT STYLE="color: #262626">&ldquo;may </FONT><FONT STYLE="color: #0F0F0F">reveal
whether the patentee has used a term in a way different from its plain meaning,&rdquo; <FONT STYLE="font-size: 10pt">Brookhill-Wilk,
</FONT>334 F</FONT><FONT STYLE="color: #3F3F3F">.</FONT><FONT STYLE="color: #0F0F0F">3d at 1298, and &ldquo;the surrounding words of
the claim.&rdquo; <FONT STYLE="font-size: 10pt">ACTV, Inc</FONT></FONT><FONT STYLE="font-size: 10pt; color: #3F3F3F">.</FONT></I><I>
<FONT STYLE="font-size: 10pt; color: #0F0F0F">v</FONT></I><I><FONT STYLE="font-size: 10pt; color: #3F3F3F">.</FONT></I><I> <FONT STYLE="font-size: 10pt; color: #0F0F0F">Walt
Disney Co</FONT></I><I><FONT STYLE="font-size: 10pt; color: #545454">.,</FONT> <FONT STYLE="color: #0F0F0F">346 F.3d 1082, 1088 (Fed.
Cir. 2003).</FONT></I></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.1pt; margin: 0pt 11.35pt 0pt 7.35pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.4pt; margin: 0pt 11.9pt 0pt 6.6pt"><FONT STYLE="color: #0F0F0F">In addition
to &ldquo;the words of the claims themselves</FONT><FONT STYLE="color: #3F3F3F">, </FONT><FONT STYLE="color: #0F0F0F">the remainder of
the specification, [and] the prosecution history,&rdquo; a court may also consider &ldquo;extrinsic evidence concerning relevant scientific
principles, the meaning of technical terms, and the state of the art.&rdquo; <FONT STYLE="font-size: 10pt"><I>Innova, </I></FONT>381 F.3d
at 1116; <FONT STYLE="font-size: 10pt"><I>see also Gemstar-TV Guide Int&rsquo;!, Inc. v. Int&rsquo;! Trade Comm&rsquo;n,</I></FONT> 383
F</FONT><FONT STYLE="color: #3F3F3F">.</FONT><FONT STYLE="color: #0F0F0F">3d 1352, 1364 (Fed. Cir. 2004). Even </FONT><FONT STYLE="color: #262626">&ldquo;[o]ther
</FONT><FONT STYLE="color: #0F0F0F">claims of the patent in question, both asserted and unasserted, can [] be valuable sources of enlightenment
as to the meaning of a claim term.&rdquo; <FONT STYLE="font-size: 10pt"><I>Vitronics, </I></FONT>90 F</FONT><FONT STYLE="color: #3F3F3F">.</FONT><FONT STYLE="color: #0F0F0F">3d
at 1582. In short, the &ldquo;entire patent&rdquo; matters, <FONT STYLE="font-size: 10pt"><I>Phillips, </I></FONT>415 F.3d at 1313; <FONT STYLE="font-size: 10pt"><I>Multiform
Desiccants, Inc. v. Medzam, Ltd, </I></FONT>133 F.3d 1473, 1477 (Fed. Cir. 1998), and </FONT><FONT STYLE="color: #262626">&ldquo;[t]he
</FONT><FONT STYLE="color: #0F0F0F">construction that stays true to the claim language&rdquo; while &ldquo;most naturally align[ing] with
the patent&rsquo;s description of the invention will be, in the end, the correct construction.&rdquo; <FONT STYLE="font-size: 10pt"><I>Renishaw
PLC v. Marposs Societa&rsquo; per Azioni, </I></FONT>158 F.3d 1243, 1250 (Fed. Cir. 1998).</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.4pt; margin: 0pt 11.9pt 0pt 6.6pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 5 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
<TR STYLE="vertical-align: middle">
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6956&nbsp; </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
</TABLE>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

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<TD STYLE="width: 7.45pt"></TD><TD STYLE="width: 35.95pt"><FONT STYLE="letter-spacing: -0.05pt">IV.</FONT></TD><TD>DISCUSSION</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B></B></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 0.6in; color: #0F0F0F">The Court considers the parties&rsquo; disputed terms below.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 0.6in; color: #0F0F0F">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top">
<TD STYLE="width: 43.15pt"></TD><TD STYLE="width: 17.7pt"><FONT STYLE="letter-spacing: -0.05pt">A.</FONT></TD><TD>&ldquo;Lipid vesicle&rdquo;</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B></B></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.35pt; margin: 0pt 11.35pt 0pt 6.85pt"><FONT STYLE="color: #0F0F0F">The
parties dispute the scope of the first term to be construed</FONT><FONT STYLE="color: #424242">.</FONT> <FONT STYLE="color: #0F0F0F">Plaintiffs
argue that the Court should construe the term </FONT><FONT STYLE="color: #212121">&ldquo;lipid </FONT><FONT STYLE="color: #0F0F0F">vesicle&rdquo;
rather than just </FONT><FONT STYLE="color: #212121">&ldquo;vesicle&rdquo; </FONT><FONT STYLE="color: #0F0F0F">alone because this better
aligns with the claim language</FONT><FONT STYLE="color: #333333">; </FONT><FONT STYLE="color: #212121">&ldquo;vesicle&rdquo; </FONT><FONT STYLE="color: #0F0F0F">alone
is never recited by the patents&rsquo; claims. Plfs Op. Br. at 2-3. Also, the patent specification includes an express definition for
</FONT><FONT STYLE="color: #212121">&ldquo;lipid </FONT><FONT STYLE="color: #0F0F0F">vesicle,&rdquo; which Plaintiffs contend this Court
should treat as controlling in accordance with Federal Circuit precedent. <I>Id. </I>at 3-4. Based on a portion of this express definition,
Plaintiffs ask the Court to interpret</FONT> <FONT STYLE="color: #212121">&ldquo;lipid</FONT> <FONT STYLE="color: #0F0F0F">vesicle&rdquo;
to mean </FONT><FONT STYLE="color: #333333">&ldquo;</FONT><FONT STYLE="color: #0F0F0F">a lipid composition that can be used to deliver
a compound.&rdquo; <I>Id.</I> at 2</FONT><FONT STYLE="color: #424242">.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.35pt; margin: 0pt 11.35pt 0pt 6.85pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.25pt; margin: 0pt 11.95pt 0pt 6.6pt"><FONT STYLE="color: #0F0F0F; letter-spacing: -0.05pt">Defendants</FONT>
<FONT STYLE="color: #0F0F0F">ask the Court to instead construe</FONT> <FONT STYLE="color: #212121">&ldquo;vesicle&rdquo;</FONT> <FONT STYLE="color: #0F0F0F">alone</FONT><FONT STYLE="color: #333333">,</FONT>
<FONT STYLE="color: #0F0F0F">and to interpret it to mean</FONT> <FONT STYLE="color: #424242; letter-spacing: -0.05pt">&ldquo;</FONT><FONT STYLE="color: #0F0F0F; letter-spacing: -0.05pt">a</FONT>
<FONT STYLE="color: #0F0F0F">sac containing an aqueous layer or a relatively disordered lipid mixture.&rdquo; Defs Op. Br. at 10-11. Defendants
focus on exemplary language later in the same definition paragraph of the patent specification to reach this conclusion, in conjunction
with a dictionary definition, which they assert is corroborated by surrounding language in the claims and examples in the patents. Defs
Op. Brief at 11-13. In the alternative, Defendants ask the Court to adopt the full express definition for &ldquo;lipid vesicle&rdquo;
set forth in the specification</FONT><FONT STYLE="color: #333333">.</FONT> <FONT STYLE="color: #0F0F0F"><I>Id</I></FONT><I><FONT STYLE="color: #333333">.</FONT></I>
<FONT STYLE="color: #0F0F0F">at 15.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.25pt; margin: 0pt 11.95pt 0pt 6.6pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.2pt; margin: 0pt 12.6pt 0pt 6pt"><FONT STYLE="color: #0F0F0F">The Court
first resolves the scope of its construction for this term. First, as Plaintiffs note,</FONT> <FONT STYLE="color: #212121">&ldquo;vesicle&rdquo;
</FONT><FONT STYLE="color: #0F0F0F">does not appear anywhere in the claims alone. Second, even a casual reading of the patents&rsquo;
disclosure makes clear that the invention is focused on lipid vesicles</FONT><FONT STYLE="color: #333333">, </FONT><FONT STYLE="color: #0F0F0F">not
vesicles in general. <I>See, e.g.</I></FONT><I><FONT STYLE="color: #333333">, </FONT></I><FONT STYLE="color: #0F0F0F">&lsquo;651 Patent
5:46-49 (Under </FONT><FONT STYLE="color: #212121">&ldquo;General&rdquo; </FONT><FONT STYLE="color: #0F0F0F">subheading</FONT><FONT STYLE="color: #333333">:
</FONT><FONT STYLE="color: #0F0F0F">&ldquo;the present invention provides processes and apparatus for making lipid vesicles.&rdquo;);
ABSTRACT (&ldquo;The present <FONT STYLE="letter-spacing: -0.05pt">invention provides apparatus</FONT> and processes for producing liposomes.&rdquo;)
The Court therefore finds</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.2pt; margin: 0pt 12.6pt 0pt 6pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 6 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6957&nbsp; </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
</TABLE>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 13pt 0pt 7.8pt"><FONT STYLE="color: #161616">that it would be inappropriate to consider</FONT>
<FONT STYLE="color: #2D2D2D">&ldquo;vesicle&rdquo; </FONT><FONT STYLE="color: #161616">divorced from the patent&rsquo;s specific, lipid
context as Defendants propose.</FONT></P>

<P STYLE="font-size: 10pt; margin: 0pt 13pt 0pt 7.8pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 79.8pt"></TD><TD STYLE="width: 36.25pt"><FONT STYLE="color: #161616"><I>1.</I></FONT></TD><TD><FONT STYLE="color: #161616"><I>The</I></FONT><I> <FONT STYLE="color: #2D2D2D">Claim</FONT> <FONT STYLE="color: #161616">Language</FONT></I></TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><I></I></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.7pt; margin: 0pt 11.2pt 0pt 7.55pt"><FONT STYLE="color: #2D2D2D">&ldquo;Lipid
</FONT><FONT STYLE="color: #161616">vesicle&rdquo; appears in the </FONT><FONT STYLE="color: #2D2D2D">&lsquo;651 </FONT><FONT STYLE="color: #161616">Patent,
the </FONT><FONT STYLE="color: #2D2D2D">&lsquo;320 </FONT><FONT STYLE="color: #161616">Patent, and the </FONT><FONT STYLE="color: #2D2D2D">&lsquo;098
</FONT><FONT STYLE="color: #161616">Patent. The term <FONT STYLE="letter-spacing: -0.05pt">figures prominently </FONT>in the patents&rsquo;
claims. For example, claim 1 is the only independent claim of the</FONT> <FONT STYLE="color: #2D2D2D">&lsquo;651</FONT> <FONT STYLE="color: #161616">Patent
and it recites:</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.7pt; margin: 0pt 11.2pt 0pt 7.55pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #161616"><TR STYLE="vertical-align: top">
<TD STYLE="width: 79.7pt"></TD><TD STYLE="width: 14.95pt"><FONT STYLE="letter-spacing: -0.05pt"><B>1.</B></FONT></TD><TD><FONT STYLE="letter-spacing: -0.05pt">A <B><I>lipid vesicle </I></B>formulation</FONT> comprising:</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt"></P>

<P STYLE="font-size: 10pt; text-indent: 0.15pt; margin: 0pt 84.25pt 0pt 79.65pt; color: #161616"><FONT STYLE="letter-spacing: -0.05pt">(a)&nbsp;
</FONT>a plurality of <B><I>lipid vesicles,</I></B> wherein each <B><I>lipid vesicle</I></B> comprises:</P>

<P STYLE="margin: 0pt 84.25pt 0pt 79.65pt; font-size: 10pt; text-indent: 0.15pt; color: #161616">a cationic lipid;</P>

<P STYLE="font-size: 10pt; text-indent: 0.15pt; margin: 0pt 84.25pt 0pt 79.65pt; color: #161616"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 79.65pt; color: #161616"><FONT STYLE="letter-spacing: -0.05pt">an amphipathic lipid;</FONT>
and</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 79.65pt; color: #161616"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 79.65pt; color: #161616"><FONT STYLE="letter-spacing: -0.05pt">a polyethyleneglycol</FONT>
(PEG)-lipid; and</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 79.65pt; color: #161616"></P>

<P STYLE="font-size: 10pt; text-indent: 0.1pt; margin: 0pt 83.95pt 0pt 79.75pt; color: #161616"><FONT STYLE="letter-spacing: -0.05pt">(b)&nbsp;&nbsp;
</FONT>messenger RNA (mRNA), wherein at least 70% of the mRNA in the formulation is fully encapsulated in the <B><I>lipid vesicles</I></B><I>.</I></P>

<P STYLE="font-size: 10pt; text-indent: 0.1pt; margin: 0pt 83.95pt 0pt 79.75pt; color: #161616">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B><I></I></B></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 8pt"><FONT STYLE="color: #2D2D2D; letter-spacing: -0.1pt">&lsquo;651</FONT> <FONT STYLE="color: #161616; letter-spacing: -0.05pt">Patent
19:4</FONT><FONT STYLE="color: #464646; letter-spacing: -0.05pt">-</FONT> <FONT STYLE="color: #161616; letter-spacing: -0.05pt">12 (emphases
added).</FONT></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 8pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.85pt; margin: 0pt 10.7pt 0pt 7.3pt"><FONT STYLE="color: #161616">As a
general rule, a claim term is given its ordinary and customary meaning</FONT><FONT STYLE="color: #464646">, </FONT><FONT STYLE="color: #161616"><I>i.e.,
</I>the one that a person of ordinary skill in the art would ascribe to it at the time of the invention. <I>Phillips </I></FONT><I><FONT STYLE="color: #464646">,</FONT></I>
<FONT STYLE="color: #161616">415 F.3d at 1312-3. There are only two exceptions to this general rule: </FONT><FONT STYLE="color: #2D2D2D">&ldquo;1)
</FONT><FONT STYLE="color: #161616">when a patentee sets out a definition and acts as his own lexicographer, and 2) when the patentee
disavows the full scope of a claim term either in the specification or during prosecution.&rdquo; <I>DDR Holdings, LLC v. Priceline.com
LLC, </I>122 </FONT><FONT STYLE="color: #2D2D2D">F.4th </FONT><FONT STYLE="color: #161616">911, 915 (Fed. Cir. 2024) (citing <I>Golden
Bridge Tech., Inc. v. Apple Inc</I></FONT><I><FONT STYLE="color: #464646">.,</FONT></I> <FONT STYLE="color: #161616">758 F3d 1362</FONT><FONT STYLE="color: #464646">,</FONT>
<FONT STYLE="color: #161616">1265 (Fed. Cir. 2014).</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.85pt; margin: 0pt 10.7pt 0pt 7.3pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #161616"><TR STYLE="vertical-align: top">
<TD STYLE="width: 79.35pt"></TD><TD STYLE="width: 36pt"><FONT STYLE="letter-spacing: -0.05pt"><B><I>2.</I></B></FONT></TD><TD><I>The Specification</I></TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><I></I></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.95pt; margin: 0pt 12.6pt 0pt 7pt"><FONT STYLE="color: #161616">An inventor
acts as its own lexicographer by providing an explicit definition for a claim term in the specification. <I>Level Sleep LLC v. Sleep Number
Corp., </I>App. No. 2020-1718, 2021 WL 2934816, at *4 (Fed</FONT><FONT STYLE="color: #464646">. </FONT><FONT STYLE="color: #161616">Cir.
July 13, 2021) (citing <I>Renishaw, </I>158 F.3d at 1249). To successfully define its own term in this way, the inventor must </FONT><FONT STYLE="color: #2D2D2D">&ldquo;clearly
</FONT><FONT STYLE="color: #161616">express that intent in the written description&rdquo; and do so</FONT> <FONT STYLE="color: #2D2D2D">&ldquo;with</FONT>
<FONT STYLE="color: #161616">sufficient clarity to put one reasonably skilled in the art on notice that</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.95pt; margin: 0pt 12.6pt 0pt 7pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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<TABLE BORDER="0" CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: middle">
    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 7 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
<TR STYLE="vertical-align: middle">
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6958&nbsp; </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
</TABLE>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.2pt; margin: 0pt 11pt 0pt 8.1pt"><FONT STYLE="color: #161616">the [it]
intended to redefine the claim term.&rdquo; <I>Merck &amp; Co. v. Teva Pharm</I></FONT><I><FONT STYLE="color: #424242">., </FONT></I><FONT STYLE="color: #161616">395
F.3d 1364, 1370 (Fed. Cir. 2005).</FONT> <FONT STYLE="color: #333333">&ldquo;</FONT><FONT STYLE="color: #161616">It is not enough . .
</FONT><FONT STYLE="color: #333333">. </FONT><FONT STYLE="color: #161616">to simply disclose a single embodiment or use a word in the
same manner in all embodiments</FONT><FONT STYLE="color: #333333">, </FONT><FONT STYLE="color: #161616">the patentee must &lsquo;clearly
express an intent&rsquo; to redefine the term.&rdquo; <I>Thorner</I></FONT><I> <FONT STYLE="color: #333333">,</FONT></I> <FONT STYLE="color: #161616">669
F</FONT><FONT STYLE="color: #333333">.</FONT><FONT STYLE="color: #161616">3d at 1362 (citation omitted).</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.2pt; margin: 0pt 11pt 0pt 8.1pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.55pt; margin: 0pt 11.1pt 0pt 8.1pt"><FONT STYLE="color: #161616">The</FONT>
<FONT STYLE="color: #424242">&ldquo;</FONT><FONT STYLE="color: #161616">DETAILED DESCRIPTION&rdquo; section of the specification for the</FONT>
<FONT STYLE="color: #333333">&lsquo;</FONT><FONT STYLE="color: #161616">651 Patent</FONT><FONT STYLE="color: #333333">,</FONT> <FONT STYLE="color: #161616">includes
a &ldquo;Definitions&rdquo; subsection</FONT><FONT STYLE="color: #333333">.</FONT> <FONT STYLE="color: #161616">It contains the following
express definition for &ldquo;lipid vesicle</FONT><FONT STYLE="color: #333333">&rdquo;</FONT> <FONT STYLE="color: #161616">in the form
of a one-sentence paragraph:</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.55pt; margin: 0pt 11.1pt 0pt 8.1pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: -0.3pt; margin: 0pt 83.15pt 0pt 79.45pt"><FONT STYLE="color: #161616"><B><I>&ldquo;Lipid
vesicle&rdquo; refers to any lipid composition that can be used to deliver a compound</I></B> including</FONT><FONT STYLE="color: #333333">,</FONT>
<FONT STYLE="color: #161616">but not limited to</FONT><FONT STYLE="color: #333333">,</FONT> <FONT STYLE="color: #161616">liposomes</FONT><FONT STYLE="color: #333333">,</FONT>
<FONT STYLE="color: #161616">wherein an aqueous volume is encapsulated by an amphipathic lipid bilayer; or wherein the lipids coat an
interior comprising a large molecular component</FONT><FONT STYLE="color: #333333">, </FONT><FONT STYLE="color: #161616">such as a plasmid</FONT><FONT STYLE="color: #333333">,
</FONT><FONT STYLE="color: #161616">with a reduced aqueous interior</FONT><FONT STYLE="color: #333333">; </FONT><FONT STYLE="color: #161616">or
lipid aggregates or micelles</FONT><FONT STYLE="color: #333333">, </FONT><FONT STYLE="color: #161616">wherein the encapsulated component
is contained within a relatively disordered lipid mixture.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: -0.3pt; margin: 0pt 83.15pt 0pt 79.45pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 0 0pt 8.45pt"><FONT STYLE="color: #333333; letter-spacing: -0.05pt">&lsquo;</FONT><FONT STYLE="color: #161616; letter-spacing: -0.05pt">651
Patent 5:30-37 (emphasis</FONT> <FONT STYLE="color: #161616">added).</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 0 0pt 8.45pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.65pt; margin: 0pt 11.6pt 0pt 7.8pt"><FONT STYLE="color: #161616">The
phrase &ldquo;refers to</FONT><FONT STYLE="color: #333333">&rdquo; </FONT><FONT STYLE="color: #161616">as used in the foregoing paragraph
has been recognized as a clear expression of a patentee</FONT><FONT STYLE="color: #333333">&rsquo;</FONT><FONT STYLE="color: #161616">s
intent to define a term. <I>S</I></FONT><I><FONT STYLE="color: #333333">e</FONT><FONT STYLE="color: #161616">e</FONT><FONT STYLE="color: #333333">,
</FONT><FONT STYLE="color: #161616">e.g.</FONT><FONT STYLE="color: #333333">, </FONT><FONT STYLE="color: #161616">Parkervision</FONT><FONT STYLE="color: #424242">,
</FONT><FONT STYLE="color: #161616">In</FONT><FONT STYLE="color: #333333">c</FONT><FONT STYLE="color: #161616">. v</FONT><FONT STYLE="color: #424242">.
</FONT><FONT STYLE="color: #161616">Vidal</FONT><FONT STYLE="color: #333333">, </FONT></I><FONT STYLE="color: #161616">88 F.4th 969</FONT><FONT STYLE="color: #333333">,</FONT>
<FONT STYLE="color: #161616">976 (Fed. Cir. 2023); <I>Meds. Co. v</I></FONT><I><FONT STYLE="color: #424242">.</FONT> <FONT STYLE="color: #161616">Mylan</FONT><FONT STYLE="color: #333333">,</FONT>
<FONT STYLE="color: #161616">Inc</FONT><FONT STYLE="color: #424242">.,</FONT></I> <FONT STYLE="color: #161616">853 F.3d 1296</FONT><FONT STYLE="color: #333333">,</FONT>
<FONT STYLE="color: #161616">1306 (Fed Cir. 2017). The emphasized language in the definition in this case serves to define a &ldquo;lipid
vesicle&rdquo; insofar as it clearly states the term and that it </FONT><FONT STYLE="color: #333333">&ldquo;</FONT><FONT STYLE="color: #161616">refers
to</FONT><FONT STYLE="color: #333333">&rdquo; </FONT><FONT STYLE="color: #161616">the remainder of the sentence. Plaintiffs would prefer
to trim the construction to </FONT><FONT STYLE="color: #333333">&ldquo;</FONT><FONT STYLE="color: #161616">any lipid composition that
can be used to deliver a compound</FONT><FONT STYLE="color: #424242">,&rdquo; </FONT><FONT STYLE="color: #161616">and ignore the remainder
of the specification&rsquo;s definition. Indeed, the remainder is unwieldy</FONT><FONT STYLE="color: #333333">, </FONT><FONT STYLE="color: #161616">but
it is not so easily dismissed. It is part of the patents&rsquo; own express definition and serves the nontrivial <FONT STYLE="letter-spacing: -0.05pt">function</FONT>
of providing those of skill in the art with three non-limiting examples that fall within the</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.25pt; margin: 0pt 11.5pt 0pt 7.55pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 8 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6959&nbsp; </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
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<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.1pt; margin: 0pt 0.15in 0pt 7.55pt"><FONT STYLE="color: #0F0F0F">scope
of the contemplated lipid vesicle.<SUP>2</SUP> The Court therefore finds that the specification favors Defendants&rsquo; alternative position:
that the entire definition in the specification be adopted as the Court</FONT><FONT STYLE="color: #2F2F2F">&rsquo;</FONT> <FONT STYLE="color: #0F0F0F">s
construction of &ldquo;lipid vesicle.&rdquo;</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.1pt; margin: 0pt 0.15in 0pt 7.55pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top">
<TD STYLE="width: 79.65pt"></TD><TD STYLE="width: 35.9pt"><FONT STYLE="letter-spacing: -0.05pt"><B><I>3.</I></B></FONT></TD><TD><I>The Prosecution History</I></TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><I></I></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.1pt; margin: 0pt 12.2pt 0pt 7.3pt"><FONT STYLE="color: #0F0F0F">Neither
party cites evidence from the prosecution history that is relevant to the construction of &ldquo;lipid vesicle.</FONT><FONT STYLE="color: #2F2F2F">&rdquo;</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.1pt; margin: 0pt 12.2pt 0pt 7.3pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; font-style: italic; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top">
<TD STYLE="width: 79.4pt"></TD><TD STYLE="width: 36.05pt"><FONT STYLE="letter-spacing: -0.05pt"><B>4.</B></FONT></TD><TD>Extrinsic Evidence</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><I></I></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.7pt; margin: 0pt 11.8pt 0pt 6.65pt"><FONT STYLE="color: #0F0F0F">Both
parties offer extrinsic evidence in favor of their preferred construction for &ldquo;lipid <FONT STYLE="letter-spacing: -0.05pt">vesicle&rdquo;
in the form of dictionaries and</FONT> prior art. Courts may consider such evidence if they deem it helpful to discern the meaning of
claim terms. <FONT STYLE="font-size: 10pt"><I>Phillips, </I></FONT>415 F3.d at 1319; <FONT STYLE="font-size: 10pt"><I>Markman, </I></FONT>52
F.3d at 980</FONT><FONT STYLE="color: #3D3D3D">.</FONT> <FONT STYLE="color: #0F0F0F">But extrinsic evidence is &ldquo;less significant
than the intrinsic record in determining &lsquo;the legally operative meaning of claim language.&rsquo;&rdquo; <FONT STYLE="font-size: 10pt"><I>C.R.
Bard, Inc</I></FONT></FONT><I><FONT STYLE="font-size: 10pt; color: #525252">. </FONT></I><I><FONT STYLE="font-size: 10pt; color: #0F0F0F">v.
US Surgical Corp</FONT></I><I><FONT STYLE="font-size: 10pt; color: #2F2F2F">., </FONT></I><FONT STYLE="color: #0F0F0F">388 F.3d 858, 862
(Fed. Cir. 2004) (quoting <FONT STYLE="font-size: 10pt"><I>Vanderlande Indus. Nederland BV v. Int&rsquo;l Trade Comm&rsquo;n, </I></FONT>366
F.3d 1311</FONT><FONT STYLE="color: #3D3D3D">,</FONT> <FONT STYLE="color: #0F0F0F">1318 (Fed. Cir. 2004)).</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.7pt; margin: 0pt 11.8pt 0pt 6.65pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.25pt; margin: 0pt 12.55pt 0pt 6.6pt"><FONT STYLE="color: #0F0F0F">Here,
the Court&rsquo;s analysis can end because it has concluded, based on the intrinsic evidence, that &ldquo;lipid vesicle</FONT><FONT STYLE="color: #2F2F2F">&rdquo;</FONT>
<FONT STYLE="color: #0F0F0F">unambiguously means</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.25pt; margin: 0pt 12.55pt 0pt 6.6pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: -0.1pt; margin: 0pt 84.6pt 0pt 78.45pt"><FONT STYLE="color: #2F2F2F">&ldquo;</FONT><FONT STYLE="color: #0F0F0F">any
lipid composition that can be used to deliver a compound including</FONT><FONT STYLE="color: #3D3D3D">, </FONT><FONT STYLE="color: #0F0F0F">but
not limited to, liposomes, wherein an aqueous volume is encapsulated by an amphipathic lipid bilayer; or wherein the lipids coat an interior
comprising a large molecular component, such as a plasmid, with a reduced aqueous interior; or lipid aggregates or micelles, wherein the
encapsulated component is contained within a relatively disordered lipid mixture.&rdquo;</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: -0.1pt; margin: 0pt 84.6pt 0pt 78.45pt">&nbsp;</P>

<P STYLE="margin: 0pt 84.6pt 0pt 78.45pt; font-size: 10pt; text-align: justify; text-indent: -0.1pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="margin: 0pt 13.1pt 0pt 5.8pt; font-size: 10pt; text-align: justify; text-indent: 0.25pt">______________________</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.25pt; margin: 0pt 13.1pt 0pt 5.8pt"><FONT STYLE="font-size: 9pt; color: #2F2F2F"><SUP>2</SUP></FONT>
<FONT STYLE="font-size: 9pt; color: #0F0F0F">At this early stage of the proceedings, it is easy to envision a scenario where the parties
later dispute the scope of what is taught by a particular piece of prior art and to what extent it teaches the same or similar </FONT><FONT STYLE="font-size: 9pt; color: #2F2F2F">&ldquo;</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">lipid
vesicle</FONT><FONT STYLE="font-size: 9pt; color: #3D3D3D">.</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">&rdquo; In that scenario</FONT><FONT STYLE="font-size: 9pt; color: #2F2F2F">,
</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">even the non-limiting examples might prove informative.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.25pt; margin: 0pt 13.1pt 0pt 5.8pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 9 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6960&nbsp; </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
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<P STYLE="font-size: 10pt; text-indent: -0.15pt; margin: 0pt 0 0pt 7.3pt"><FONT STYLE="color: #0F0F0F"><I>See Vitronics,</I> 90 F.3d at
1584</FONT><FONT STYLE="color: #282828">.</FONT> <FONT STYLE="color: #0F0F0F">Accordingly, the Court</FONT><FONT STYLE="color: #282828">&rsquo;</FONT>
<FONT STYLE="color: #0F0F0F">s claim construction order will instruct the parties to use that definit</FONT><FONT STYLE="color: #282828">i</FONT><FONT STYLE="color: #0F0F0F">on</FONT><FONT STYLE="color: #282828">.</FONT><FONT STYLE="color: #0F0F0F"><SUP>3</SUP></FONT></P>

<P STYLE="font-size: 10pt; text-indent: -0.15pt; margin: 0pt 0 0pt 7.3pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top">
<TD STYLE="width: 43pt"></TD><TD STYLE="width: 17.8pt"><FONT STYLE="letter-spacing: -0.05pt"><B>B.</B></FONT></TD><TD><B>&ldquo;fully encapsulated&rdquo;</B></TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B></B></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.25pt; margin: 0pt 11.5pt 0pt 6.8pt"><FONT STYLE="color: #0F0F0F; letter-spacing: -0.05pt">Plaintiffs
argue that &ldquo;fully encapsulated</FONT><FONT STYLE="color: #282828; letter-spacing: -0.05pt">&rdquo; </FONT><FONT STYLE="color: #0F0F0F; letter-spacing: -0.05pt">should
be interpreted to mean &ldquo;contained </FONT><FONT STYLE="color: #0F0F0F">inside</FONT><FONT STYLE="color: #282828">&rdquo;</FONT> <FONT STYLE="color: #0F0F0F; letter-spacing: -0.05pt">in
the claims of the </FONT><FONT STYLE="color: #282828; letter-spacing: -0.05pt">&lsquo;</FONT><FONT STYLE="color: #0F0F0F; letter-spacing: -0.05pt">651,
</FONT><FONT STYLE="color: #0F0F0F">&lsquo;359, and &lsquo;378 Patents.<SUP>4</SUP> Plfs Op. Br. at 6-13; Plfs Resp. Br. at 6</FONT><FONT STYLE="color: #282828">-
</FONT><FONT STYLE="color: #0F0F0F">13. They posit that this construction is consistent with the way one of skill in the art would understand
the invention as described in the specification and reinforced by the patents&rsquo; prosecution histories. <I>Id.</I> In support of this
argument Plaintiffs cite the specification and prosecution histories in combination with a declaration from their expert, David H. Thompson,
Ph.D.<SUP>5</SUP> <I>Id. </I>Plaintiffs also dispute the claim construction for &ldquo;fully encapsulated&rdquo; already reached by a
Delaware district court in Plaintiffs&rsquo; separate infringement suit in that district: <I>Arbutu</I></FONT><I><FONT STYLE="color: #282828">s
</FONT><FONT STYLE="color: #0F0F0F">Biopharma Corp</FONT><FONT STYLE="color: #565656">. </FONT><FONT STYLE="color: #0F0F0F">v</FONT><FONT STYLE="color: #282828">.
</FONT><FONT STYLE="color: #0F0F0F">Moderna Inc.</FONT><FONT STYLE="color: #282828">,</FONT></I> <FONT STYLE="color: #0F0F0F">Civ. No.
22-252, 2024 WL 1434526 (D. Del. Apr. 3, 2024) <I>(&ldquo;Moderna</I> Opinion</FONT><FONT STYLE="color: #282828">&rdquo;</FONT><FONT STYLE="color: #0F0F0F">).</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.25pt; margin: 0pt 11.5pt 0pt 6.8pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.9pt; margin: 0pt 12.45pt 0pt 6.7pt"><FONT STYLE="color: #0F0F0F">Defendants</FONT><FONT STYLE="color: #282828">,
</FONT><FONT STYLE="color: #0F0F0F">in their responsive brief, withdraw their initially proposed construction. Defs Resp. Br. at 10 (&ldquo;In
view of Plaintiffs</FONT><FONT STYLE="color: #282828">&rsquo; </FONT><FONT STYLE="color: #0F0F0F">arguments and the deposition of their
expert</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0F0F0F">Defendants withdraw their original construction and</FONT><FONT STYLE="color: #282828">,</FONT>
<FONT STYLE="color: #0F0F0F">per the Court&rsquo;s order</FONT><FONT STYLE="color: #282828">,</FONT> <FONT STYLE="color: #0F0F0F">will
argue indefiniteness at a later stage</FONT><FONT STYLE="color: #464646">.</FONT><FONT STYLE="color: #0F0F0F">&rdquo;) Defendants now
maintain that the claim term is indefinite and ask the Court to reject</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.9pt; margin: 0pt 12.45pt 0pt 6.7pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="margin: 0pt 12.6pt 0pt 6.45pt; font-size: 10pt; text-align: justify; text-indent: 0.1pt">___________________________</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.1pt; margin: 0pt 12.6pt 0pt 6.45pt"><FONT STYLE="font-size: 10pt; color: #282828"><SUP>3</SUP></FONT>
<FONT STYLE="font-size: 10pt; color: #0F0F0F">The Court is also mindful that this full construction may prove unwieldy at trial given
that it </FONT><FONT STYLE="font-size: 10pt; color: #282828">a</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">nticipates trial to
a jury</FONT><FONT STYLE="font-size: 10pt; color: #464646">.</FONT> <FONT STYLE="font-size: 10pt; color: #0F0F0F">As a matter of trial
logistics</FONT><FONT STYLE="font-size: 10pt; color: #282828">, </FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">the Court suggests
the parties confer and consider stipulating to a </FONT><FONT STYLE="font-size: 10pt; color: #282828">s</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">horter
claim construction in light of the Court</FONT><FONT STYLE="font-size: 10pt; color: #282828">&rsquo;</FONT> <FONT STYLE="font-size: 10pt; color: #0F0F0F">s
conclusion here</FONT><FONT STYLE="font-size: 10pt; color: #282828">.&nbsp;</FONT></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 6.7pt"><FONT STYLE="font-size: 10pt; color: #0F0F0F; letter-spacing: -0.05pt"><SUP>4</SUP>
More accuratel</FONT><FONT STYLE="font-size: 10pt; color: #282828; letter-spacing: -0.05pt">y,</FONT> <FONT STYLE="font-size: 10pt; color: #0F0F0F; letter-spacing: -0.05pt">Plaintiffs
seek construction of</FONT> <FONT STYLE="font-size: 10pt; color: #282828; letter-spacing: -0.05pt">&ldquo;</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F; letter-spacing: -0.05pt">fully
encap</FONT><FONT STYLE="font-size: 10pt; color: #282828; letter-spacing: -0.05pt">s</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F; letter-spacing: -0.05pt">ulated</FONT><FONT STYLE="font-size: 10pt; color: #282828; letter-spacing: -0.05pt">&rdquo;</FONT> <FONT STYLE="font-size: 10pt; color: #0F0F0F; letter-spacing: -0.05pt">as
their primary position</FONT> <FONT STYLE="font-size: 10pt; color: #0F0F0F">for the</FONT> <FONT STYLE="font-size: 10pt; color: #282828">&lsquo;</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">359
and </FONT><FONT STYLE="font-size: 10pt; color: #282828; letter-spacing: -0.05pt">&lsquo;</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F; letter-spacing: -0.05pt">378
Patents, and their secondary position for the </FONT><FONT STYLE="font-size: 10pt; color: #282828; letter-spacing: -0.05pt">&lsquo;</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F; letter-spacing: -0.05pt">651
Patent. For </FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">the </FONT><FONT STYLE="font-size: 10pt; color: #282828">&lsquo;</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">651
Patent</FONT><FONT STYLE="font-size: 10pt; color: #282828">, </FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">Plaintiffs</FONT><FONT STYLE="font-size: 10pt; color: #282828">&rsquo;</FONT> <FONT STYLE="font-size: 10pt; color: #0F0F0F">first
pos</FONT><FONT STYLE="font-size: 10pt; color: #282828">i</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">t</FONT><FONT STYLE="font-size: 10pt; color: #282828">i</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">on
is that the Court should construe the entire phrase </FONT><FONT STYLE="font-size: 10pt; color: #282828">&ldquo;</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">wherein
at least 70% of the mRNA in the formulation i</FONT><FONT STYLE="font-size: 10pt; color: #282828">s </FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">fully
encapsulated in the lipid vesicles</FONT><FONT STYLE="font-size: 10pt; color: #282828">&rdquo;</FONT> <FONT STYLE="font-size: 10pt; color: #0F0F0F">to
mean </FONT><FONT STYLE="font-size: 10pt; color: #282828">&ldquo;</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">wherein at
least 70% of the mRNA in the formulation is contained in the lipid vesicles.</FONT><FONT STYLE="font-size: 10pt; color: #282828">&rdquo;</FONT> <FONT STYLE="font-size: 10pt; color: #0F0F0F">The
remainder of the phrase proposed by Plaintiffs merely restates the language of the wherein clause. The Court finds no value in
presenting this more complicated phrase to the jury. Accordingly</FONT><FONT STYLE="font-size: 10pt; color: #282828">, </FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">the
Court herein construes only &ldquo;fully encapsulated</FONT><FONT STYLE="font-size: 10pt; color: #282828">&rdquo;</FONT> <FONT STYLE="font-size: 10pt; color: #0F0F0F">for
the benefit of the parties and the jury</FONT><FONT STYLE="font-size: 10pt; color: #464646">.&nbsp;</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 0 0pt 6.3pt"><FONT STYLE="font-size: 10pt; color: #0F0F0F"><I><SUP>5</SUP></I>
Dr. Thompson is a professor of</FONT> <FONT STYLE="font-size: 10pt; color: #282828">c</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">hem</FONT><FONT STYLE="font-size: 10pt; color: #282828">i</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">stry
at Purdue University and is the former Director of the Medicinal Chemistry Group in the Purdue Center for Cancer Research</FONT><FONT STYLE="font-size: 10pt; color: #565656">.</FONT>
<FONT STYLE="font-size: 10pt; color: #0F0F0F">(Thompson Deel. &para;1</FONT><FONT STYLE="font-size: 10pt; color: #282828"><B>, </B></FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">ECF
No. 84-5.) At least for the purposes of <FONT STYLE="letter-spacing: -0.05pt">claim construction</FONT></FONT><FONT STYLE="font-size: 10pt; color: #282828; letter-spacing: -0.05pt">,
</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F; letter-spacing: -0.05pt">Defendants do not challenge his qualifications to </FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">opine
as to the knowledge o</FONT><FONT STYLE="font-size: 10pt; color: #282828">f </FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">one
of skill in the art. To be clear</FONT><FONT STYLE="font-size: 10pt; color: #282828">, </FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">Plaintiffs
do not ask the Court to find&mdash;nor does the Court find, given Dr. Thompson&rsquo;s extensive education and experience</FONT><FONT STYLE="font-size: 10pt; color: #282828">&mdash;</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">that
he is him</FONT><FONT STYLE="font-size: 10pt; color: #282828">s</FONT><FONT STYLE="font-size: 10pt; color: #0F0F0F">elf a person of just
ordinary skill in the art.</FONT> <FONT STYLE="color: #0F0F0F"></FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 0 0pt 6.3pt">&nbsp;</P>

<P STYLE="margin: 0pt 0 0pt 6.3pt; font-size: 10pt; text-align: justify">&nbsp;</P>

<P STYLE="margin: 0pt 0 0pt 6.3pt; font-size: 10pt; text-align: justify"></P>

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    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 10 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6961 </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
</TABLE>

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<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.25pt; margin: 0pt 13.2pt 0pt 6.15pt"></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.25pt; margin: 0pt 13.2pt 0pt 6.15pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.25pt; margin: 0pt 12.2pt 0pt 7.55pt"><FONT STYLE="color: #0F0F0F">Plaintiffs&rsquo;
construction and to instead later address </FONT><FONT STYLE="color: #282828">&ldquo;</FONT><FONT STYLE="color: #0F0F0F">fully encapsulated&rdquo;
when the Court considers Defendants&rsquo; indefiniteness defense. <I>Id.</I></FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.25pt; margin: 0pt 12.2pt 0pt 7.55pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.25pt; margin: 0pt 11.5pt 0pt 7.3pt"><FONT STYLE="color: #0F0F0F">Plaintiffs
object to Defendants&rsquo; proposal to delay claim construction on the basis that this would impermissibly impose upon the jury a claim
construction dispute that the Court is obligated to first resolve. Plfs Resp. Br. at 6. Because the Court agrees that it has a duty to
resolve any <FONT STYLE="letter-spacing: -0.05pt">claim construction</FONT> disputes in advance of any presentation to the jury, the Court
proceeds with its claim construction analysis</FONT><FONT STYLE="color: #3B3B3B">.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.25pt; margin: 0pt 11.5pt 0pt 7.3pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 80.45pt; color: #0F0F0F"><I>I.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Delaware District
Court&rsquo;s Construction in Moderna Litigation</I></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 80.45pt; color: #0F0F0F">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><I></I></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.7pt; margin: 0pt 12.25pt 0pt 6.75pt"><FONT STYLE="color: #0F0F0F">The
Court begins with its sister court&rsquo;s construction in the <I>Moderna </I>Opinion</FONT><FONT STYLE="color: #3B3B3B">.</FONT> <FONT STYLE="color: #0F0F0F">That
decision construed &ldquo;fully encapsulated&rdquo; in the &lsquo;651 Patent as part of the longer phrase &ldquo;wherein at least 70%</FONT><FONT STYLE="color: #282828">/</FONT><FONT STYLE="color: #0F0F0F">at
least 80%/about 90% of the mRNA in the formulation is encapsulated in the lipid vesicles.&rdquo; There</FONT><FONT STYLE="color: #3B3B3B">,</FONT>
<FONT STYLE="color: #0F0F0F">Arbutus sought the same construction of &ldquo;fully encapsulated&rdquo; that they seek here: &ldquo;contained
inside.&rdquo; The court, however</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0F0F0F">adopted Moderna</FONT><FONT STYLE="color: #282828">&rsquo;</FONT><FONT STYLE="color: #0F0F0F">s
proposed construction</FONT><FONT STYLE="color: #3B3B3B">: </FONT><FONT STYLE="color: #0F0F0F">&ldquo;wherein at least 70%</FONT><FONT STYLE="color: #282828">/</FONT><FONT STYLE="color: #0F0F0F">at
least 80%</FONT><FONT STYLE="color: #282828">/</FONT><FONT STYLE="color: #0F0F0F">about 90% of the mRNA in the formulation is <FONT STYLE="font-size: 10pt"><B><I>fully,
as distinct from partially, contained inside </I></B></FONT>the lipid vesicles</FONT><FONT STYLE="color: #282828">.</FONT><FONT STYLE="color: #0F0F0F">&rdquo;
<I>Moderna </I>Opinion, 2024 WL 1434526, at </FONT><FONT STYLE="color: #282828">*</FONT><FONT STYLE="color: #0F0F0F">18. In reaching that
conclusion, the court sought to apply the plain meaning of the claim terms and to give effect to the word &ldquo;fully&rdquo; that was
consistent with its reading of the specification</FONT><FONT STYLE="color: #282828">. </FONT><FONT STYLE="color: #0F0F0F"><I>Id. </I>at
*17- 18.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.7pt; margin: 0pt 12.25pt 0pt 6.75pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.7pt; margin: 0pt 13pt 0pt 6.25pt"><FONT STYLE="color: #0F0F0F">The <I>Moderna</I>
court</FONT><FONT STYLE="color: #282828">&rsquo;</FONT><FONT STYLE="color: #0F0F0F">s construction is</FONT><FONT STYLE="color: #282828">,
</FONT><FONT STYLE="color: #0F0F0F">of course not binding on this Court</FONT><FONT STYLE="color: #3B3B3B">.</FONT> <FONT STYLE="color: #0F0F0F">For
the reasons set forth below&mdash;faced with different arguments and a different record&mdash;this Court reaches a similar but somewhat
different construction</FONT><FONT STYLE="color: #4B4B4B">.</FONT> <FONT STYLE="color: #0F0F0F">The Court agrees that </FONT><FONT STYLE="color: #282828">&ldquo;</FONT><FONT STYLE="color: #0F0F0F">fully
encapsulated&rdquo; means</FONT> <FONT STYLE="color: #282828">&ldquo;</FONT><FONT STYLE="color: #0F0F0F">contained inside&rdquo; (as proposed
by Plaintiffs), but the Court declines to add the language &ldquo;as distinct from partially&rdquo; that was inserted by the <I>Moderna</I>
court.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.7pt; margin: 0pt 13pt 0pt 6.25pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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<TR STYLE="vertical-align: middle">
    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 11 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6962 </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
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<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; font-style: italic; margin: 0pt 0 0pt 79.4pt; text-align: justify; text-indent: 0in; color: #0E0E0E">2. The
Claim Language</P>

<P STYLE="font-size: 10pt; font-style: italic; margin: 0pt 0 0pt 79.4pt; text-align: justify; text-indent: 0in; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><I></I></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.1pt; margin: 0pt 11.2pt 0pt 7.05pt"><FONT STYLE="color: #0E0E0E">The term
&ldquo;fully encapsulated&rdquo; appears in the </FONT><FONT STYLE="color: #262626">&lsquo;651, </FONT><FONT STYLE="color: #0E0E0E">&lsquo;359,
and &lsquo;378 Patents, though in slightly different contexts. The &lsquo;651 Patent uses the term in the context of claiming the overall
formulation, while the</FONT> <FONT STYLE="color: #262626">&lsquo;359</FONT> <FONT STYLE="color: #0E0E0E">and &lsquo;378 Patents use the
term in the context of claiming the individual nucleic acid-lipid particles.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.1pt; margin: 0pt 11.2pt 0pt 7.05pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 43.1pt; color: #0E0E0E">Claim 1 of the &lsquo;651 Patent is set forth below:</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 43.1pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0E0E0E"><TR STYLE="vertical-align: top">
<TD STYLE="width: 79.15pt"></TD><TD STYLE="width: 17.9pt">1.</TD><TD STYLE="text-align: justify">A lipid vesicle formulation comprising:</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-indent: 0.15pt; margin: 0pt 84.5pt 0pt 92.4pt; color: #0E0E0E"><FONT STYLE="letter-spacing: -0.05pt">(a)&nbsp;&nbsp;&nbsp;&nbsp;
</FONT>a plurality of lipid vesicles, wherein each lipid vesicle comprises:</P>

<P STYLE="font-size: 10pt; text-indent: 0.15pt; margin: 0pt 84.5pt 0pt 92.4pt; color: #0E0E0E"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 115pt; color: #0E0E0E">a cationic lipid;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 115pt; color: #0E0E0E"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 115pt; color: #0E0E0E">an amphipathic lipid; and</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 115pt; color: #0E0E0E"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 115pt; color: #0E0E0E">a polyethyleneglycol (PEG)-lipid; and</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 115pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0E0E0E"><TR STYLE="vertical-align: top">
<TD STYLE="width: 92.3pt"></TD><TD STYLE="width: 0.15pt"><FONT STYLE="letter-spacing: -0.05pt">(b)</FONT></TD><TD STYLE="padding-right: 84.8pt">&nbsp;messenger RNA (mRNA), wherein at least 70% of the mRNA in the formulation is <B><I>fully encapsulated</I></B>
in the lipid vesicles.</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-indent: 0.4pt; margin: 0pt 0 0pt 6.85pt"><FONT STYLE="color: #0E0E0E">&lsquo;651 Patent 19: 4-12 (emphasis
added). Claim 1 of the &lsquo;359 Patent is set forth below with its dependent claim 20 that adds a</FONT> <FONT STYLE="color: #262626">&ldquo;fully</FONT>
<FONT STYLE="color: #0E0E0E">encapsulated&rdquo; claim limitation:</FONT></P>

<P STYLE="font-size: 10pt; text-indent: 0.4pt; margin: 0pt 0 0pt 6.85pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0E0E0E"><TR STYLE="vertical-align: top">
<TD STYLE="width: 78.7pt"></TD><TD STYLE="width: 18.1pt">1.</TD><TD STYLE="text-align: justify">A nucleic acid-lipid particle comprising:</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0E0E0E"><TR STYLE="vertical-align: top">
<TD STYLE="width: 96.6pt"></TD><TD STYLE="width: 16.25pt"><FONT STYLE="letter-spacing: -0.05pt">(a)</FONT></TD><TD STYLE="text-align: justify">a nucleic acid;</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0E0E0E"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 96.6pt; text-align: right"><FONT STYLE="font-size: 10pt; letter-spacing: -0.05pt"></FONT></TD><TD STYLE="width: 16.25pt">(b)</TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">a cationic lipid comprising from 50 mol </FONT>% <FONT STYLE="font-size: 10pt">to
65 mol </FONT>% <FONT STYLE="font-size: 10pt">of the total lipid present in the particle;</FONT></TD>
</TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0E0E0E"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 96.6pt; text-align: right"><FONT STYLE="font-size: 10pt; letter-spacing: -0.05pt"></FONT></TD><TD STYLE="width: 16.25pt">(c)</TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">a non-cationic lipid comprising a mixture of a phospholipid
and cholesterol or a derivative thereof, wherein the phospholipid comprises from 3 mol % to 15 mol % of the total lipid present in the
particle and the cholesterol or derivative thereof comprises from 30 mol </FONT>% <FONT STYLE="font-size: 10pt">to 40 mol </FONT>% <FONT STYLE="font-size: 10pt">of
the total lipid present in the particle; and</FONT></TD>
</TR></TABLE>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.2pt; margin: 0pt 85pt 0pt 96.45pt; color: #0E0E0E"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0E0E0E"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 96.6pt; text-align: right"><FONT STYLE="font-size: 10pt; letter-spacing: -0.05pt"></FONT></TD><TD STYLE="width: 16.25pt">(d)</TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">a conjugated lipid that inhibits aggregation of particles comprising
from 0.5 mol </FONT>% <FONT STYLE="font-size: 10pt">to 2 mol </FONT>% <FONT STYLE="font-size: 10pt">of the total lipid present in the
particle.</FONT></TD>
</TR></TABLE>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.15pt; margin: 0pt 85.45pt 0pt 96.5pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.15pt; margin: 0pt 85.25pt 0pt 78.25pt"><FONT STYLE="color: #0E0E0E">20.
The nucleic acid-lipid particle of claim 1, wherein the nucleic <FONT STYLE="letter-spacing: -0.05pt">acid is <B><I>fully encapsulated</I></B>
in the nucleic acid-lipid</FONT> particle</FONT><FONT STYLE="color: #444444">.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.15pt; margin: 0pt 85.25pt 0pt 78.25pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-indent: 0.6pt; margin: 0pt 13pt 0pt 6.15pt"><FONT STYLE="color: #0E0E0E">&lsquo;359 Patent 91:13-25;
92:43-45 (emphasis added)</FONT><FONT STYLE="color: #444444">.</FONT> <FONT STYLE="color: #0E0E0E">&ldquo;Fully encapsulated&rdquo; appears
in the claims of the</FONT> <FONT STYLE="color: #262626">&lsquo;378</FONT> <FONT STYLE="color: #0E0E0E">Patent via a more elongated chain
of dependent claims.&#9;Claim 9, which ultimately</FONT></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 7.8pt; color: #0E0E0E"></P>

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    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 12 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6963 </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
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<P STYLE="margin: 0pt 0 0pt 7.8pt; font-size: 10pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="margin: 0pt 0 0pt 7.8pt; font-size: 10pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="margin: 0pt 0 0pt 7.8pt; font-size: 10pt; color: #0E0E0E">depends from claim <FONT STYLE="font-size: 10pt">1<B>,</B></FONT>
is directed to a pharmaceutical composition comprising the fully encapsulated nucleic acid-lipid particles:</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 7.8pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 79.85pt; color: #0E0E0E">9. The pharmaceutical composition of claim 8, wherein the RNA is</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 79.85pt; color: #0E0E0E"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 79.25pt; color: #0E0E0E"><B><I>fully encapsulated</I></B> in the nucleic acid-lipid particle.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 79.25pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-indent: 0.6pt; margin: 0pt 13pt 0pt 7.35pt"><FONT STYLE="color: #0E0E0E">&lsquo;378 Patent 93:46-48 (emphasis
added). The claims of the three patents provide no guidance as to the meaning of &ldquo;fully encapsulated</FONT><FONT STYLE="color: #4B4B4B">.</FONT><FONT STYLE="color: #0E0E0E">&rdquo;</FONT></P>

<P STYLE="font-size: 10pt; text-indent: 0.6pt; margin: 0pt 13pt 0pt 7.35pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; font-style: italic; margin-top: 0pt; margin-bottom: 0pt; color: #0E0E0E"><TR STYLE="vertical-align: top">
<TD STYLE="width: 79.4pt"></TD><TD STYLE="width: 36.15pt">3.</TD><TD>The Specification</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><I></I></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.35pt; margin: 0pt 11.3pt 0pt 7.05pt"><FONT STYLE="color: #0E0E0E">The
Definitions section within the specification of the &lsquo;651 Patent also provides no explicit definition for</FONT> <FONT STYLE="color: #2A2A2A">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">fully
encapsulated.&rdquo; It does, however</FONT><FONT STYLE="color: #2A2A2A">,</FONT> <FONT STYLE="color: #0E0E0E">imply a distinction between
&ldquo;full <FONT STYLE="letter-spacing: -0.1pt">encapsulation&rdquo; </FONT><FONT STYLE="letter-spacing: -0.05pt">and &ldquo;partial
encapsulation</FONT></FONT><FONT STYLE="color: #2A2A2A; letter-spacing: -0.05pt">&rdquo;</FONT> <FONT STYLE="color: #0E0E0E; letter-spacing: -0.05pt">in
the following sentence: &ldquo;As used herein,</FONT> <FONT STYLE="color: #2A2A2A; letter-spacing: -0.05pt">&lsquo;</FONT><FONT STYLE="color: #0E0E0E; letter-spacing: -0.05pt">lipid</FONT>
<FONT STYLE="color: #0E0E0E">encapsulated&rsquo; can refer to a lipid formulation which provides a compound with full encapsulation, partial
encapsulation, or both.&rdquo;</FONT> <FONT STYLE="color: #2A2A2A">&lsquo;</FONT><FONT STYLE="color: #0E0E0E">651 Patent 5</FONT><FONT STYLE="color: #4B4B4B">:</FONT><FONT STYLE="color: #0E0E0E">38-40.
Thus</FONT><FONT STYLE="color: #2A2A2A">,</FONT> <FONT STYLE="color: #0E0E0E">full encapsulation and partial encapsulation were conditions
deemed distinct by the inventors. This distinction was important to the court in <FONT STYLE="font-size: 10pt"><I>Moderna.</I></FONT>
Unfortunately, the specification does not define &ldquo;partial encapsulation.&rdquo;</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.35pt; margin: 0pt 11.3pt 0pt 7.05pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 42.95pt"><FONT STYLE="color: #0E0E0E">A second hint lies in the definition of a &ldquo;lipid
vesicle</FONT><FONT STYLE="color: #2A2A2A">&rdquo;</FONT> <FONT STYLE="color: #0E0E0E">that provides three-nonlimiting </FONT>examples:</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 6.8pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-indent: -0.4pt; margin: 0pt 53.4pt 0pt 78.75pt; color: #0E0E0E">&ldquo;Lipid vesicle&rdquo; refers to
any lipid composition that can be used to deliver a compound including, but not limited to,</P>

<P STYLE="font-size: 10pt; text-indent: -0.4pt; margin: 0pt 53.4pt 0pt 78.75pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; margin: 0pt 53.4pt 0pt 78.7pt; color: #0E0E0E">liposomes, wherein an aqueous volume is encapsulated by an amphipathic
lipid bilayer; or</P>

<P STYLE="font-size: 10pt; margin: 0pt 53.4pt 0pt 78.7pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-indent: 0.3pt; margin: 0pt 53.4pt 0pt 78.45pt; color: #0E0E0E">wherein the lipids coat an interior comprising
a large molecular component, such as a plasmid, with a reduced aqueous interior; or</P>

<P STYLE="font-size: 10pt; text-indent: 0.3pt; margin: 0pt 53.4pt 0pt 78.45pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; margin: 0pt 53.4pt 0pt 78.45pt"><FONT STYLE="color: #0E0E0E">lipid aggregates or micelles, wherein the encapsulated
component is contained within a relatively disordered lipid mixture</FONT><FONT STYLE="color: #2A2A2A">.</FONT></P>

<P STYLE="font-size: 10pt; margin: 0pt 53.4pt 0pt 78.45pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 13 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6964 </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
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<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt"></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 1pt; margin: 0pt 12pt 0pt 6.75pt"><FONT STYLE="color: #0F0F0F">&lsquo;651
Patent 5:30-37.<SUP>6</SUP> This sentence suggests that the word &ldquo;fully&rdquo; in the claim term &ldquo;fully encapsulated&rdquo;
does have a purpose: to distinguish the first two examples from the third one. Thus, in the parlance of the third example, while the mRNA
of Claim 1 may be considered an</FONT> <FONT STYLE="color: #262626">&ldquo;encapsulated</FONT> <FONT STYLE="color: #0F0F0F">component,&rdquo;
it is not &ldquo;fully encapsulated.&rdquo; The mRNA is merely &ldquo;contained within a relatively disordered lipid mixture</FONT><FONT STYLE="color: #444444">.</FONT><FONT STYLE="color: #262626">&rdquo;</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 1pt; margin: 0pt 12pt 0pt 6.75pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top">
<TD STYLE="width: 78.7pt"></TD><TD STYLE="width: 36.2pt"><I>4.</I></TD><TD><I>The Prosecution History</I></TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><I></I></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.3pt; margin: 0pt 12.25pt 0pt 6.4pt"><FONT STYLE="color: #0F0F0F">The prosecution
history of the </FONT><FONT STYLE="color: #262626">&lsquo;651 </FONT><FONT STYLE="color: #0F0F0F">Patent reinforces this view. In a Non-Final
Office Action issued by the USPTO on August 14, 2014, the Examiner rejected a version of Claim 1 of the &lsquo;651 Patent that included
the &ldquo;fully encapsulated&rdquo; language</FONT><FONT STYLE="color: #444444">. </FONT><FONT STYLE="color: #0F0F0F">That rejection
was based on the teachings of Unger <FONT STYLE="font-size: 10pt"><I>et al</I></FONT></FONT><I><FONT STYLE="font-size: 10pt; color: #676767">.
</FONT></I><FONT STYLE="color: #0F0F0F">(U.S</FONT><FONT STYLE="color: #444444">. </FONT><FONT STYLE="color: #0F0F0F">Patent No</FONT><FONT STYLE="color: #444444">.
</FONT><FONT STYLE="color: #0F0F0F">5,830</FONT><FONT STYLE="color: #363636">,</FONT><FONT STYLE="color: #0F0F0F">430) in combination
with three other references. Plfs Op. Br., Exhibit 10 at pp. 5-9, ECF No. 84-2.<SUP>7</SUP> The inventors responded to the rejection on
October 22, 2014, in relevant part, by distinguishing their invention from what was taught by Unger with a supporting Declaration from
Dr. James Heyes. The distinction the inventors drew between their invention and Unger was that Unger teaches aggregates (like the third
example from the specification noted above) that differ from their claimed lipid vesicles with encapsulated RNA:</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.3pt; margin: 0pt 12.25pt 0pt 6.4pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.3pt; margin: 0pt 84.45pt 0pt 77.85pt"><FONT STYLE="color: #0F0F0F">Dr.
Heyes points out that lipoplexes [of Unger] are heterogeneous, <FONT STYLE="letter-spacing: -0.05pt">metastable aggregates</FONT> that
are effective when used to transfect cells in culture</FONT><FONT STYLE="color: #444444">, </FONT><FONT STYLE="color: #0F0F0F">but have
relatively poor performance <FONT STYLE="font-size: 10pt"><I>in vivo</I></FONT></FONT><I><FONT STYLE="font-size: 10pt; color: #363636">.
</FONT></I><I><FONT STYLE="font-size: 10pt; color: #0F0F0F">See, id.</FONT></I> <FONT STYLE="color: #0F0F0F">Importantly, Dr. Heyes explains
that the encapsulated mRNA present within the lipid vesicles of the present invention will be protected from nuclease degradation upon
systemic administration, while nucleic acid that is merely associated with the surface of a preformed liposome (such as the DNA of the
lipoplexes of Unger <FONT STYLE="font-size: 10pt"><I>et al.)</I></FONT> will be more readily degraded by serum nucleases.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.3pt; margin: 0pt 84.45pt 0pt 77.85pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="margin: 0pt 0 0pt 6.3pt; font-size: 10pt; text-align: justify"><FONT STYLE="font-size: 9pt">_______________________________</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 0 0pt 6.3pt"><FONT STYLE="font-size: 9pt; color: #262626"><SUP>6</SUP></FONT>
<FONT STYLE="font-size: 9pt; color: #0F0F0F">This is the same passage the Court also relies upon to construe</FONT> <FONT STYLE="font-size: 9pt; color: #262626">&ldquo;lipid
</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">vesicle</FONT><FONT STYLE="font-size: 9pt; color: #444444">.&rdquo;</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 0 0pt 6.3pt"></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.35pt; margin: 0pt 13.7pt 0pt 5.9pt"><FONT STYLE="font-size: 9pt; color: #0F0F0F"><SUP>7</SUP>
Plaintiffs&rsquo; Opening Brief appears to inadvertently refer to a later-issued Office Action dated February 13, 2015 (Exhibit 13) rather
than the Office Action issued on August 14</FONT><FONT STYLE="font-size: 9pt; color: #444444">, </FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">2014
(Exhibit 10)</FONT><FONT STYLE="font-size: 9pt; color: #444444">.</FONT> <FONT STYLE="font-size: 9pt; color: #0F0F0F"><I>See </I>Plfs
Op</FONT><FONT STYLE="font-size: 9pt; color: #444444">. </FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">Br. at 7 (citing Exhibit
13)</FONT><FONT STYLE="font-size: 9pt; color: #444444">. </FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">This matters only insofar
as the inventors&rsquo; response</FONT><FONT STYLE="font-size: 9pt; color: #363636">, </FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">filed
October 22</FONT><FONT STYLE="font-size: 9pt; color: #363636">, </FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">2014</FONT><FONT STYLE="font-size: 9pt; color: #363636">,
</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">was for obvious reasons responsive to the 2014 Office Action rather than the 2015
one. As set forth, <I>infra, </I>there were in fact two Office Actions and two responses from the inventors</FONT><FONT STYLE="font-size: 9pt; color: #444444">.</FONT>
<FONT STYLE="font-size: 9pt; color: #0F0F0F">In both responses, the inventors distinguished the invention&rsquo;</FONT><FONT STYLE="font-size: 9pt; color: #363636">s
</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">fully encapsulated mRNA from the mere aggregates taught be Unger.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.35pt; margin: 0pt 13.7pt 0pt 5.9pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 14 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6965 </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
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<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: -0.1pt; margin: 0pt 12.5pt 0pt 6.85pt; color: #0E0E0E">Exhibit 11 at p. 7.
The inventors reiterated this distinction in their May 12, 2015 response (Exhibit 14) to the next Office Action issued February 13, 2015
(Exhibit 13), again based in part on Unger.</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: -0.1pt; margin: 0pt 12.5pt 0pt 6.85pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.35pt; margin: 0pt 73pt 0pt 78.9pt"><FONT STYLE="color: #0E0E0E">In fact,
Unger <I>et al.</I> fails to provide any clear and specific teaching with <FONT STYLE="letter-spacing: -0.05pt">regard to the successful
encapsulation </FONT>and delivery of mRNA</FONT><FONT STYLE="color: #424242">. </FONT><FONT STYLE="color: #0E0E0E">Indeed, <B><I>none
of the examples in Unger et al. discloses or suggests a lipid vesicle of the present invention comprising fully encapsulated mRNA</I></B>
or the desirability of forming smaller lipid vesicles that are more effective at delivering encapsulated nucleic acid molecules such as
mRNA to living cells. <B><I>The cationic lipid compounds and cationic liposome formulations disclosed in Unger et al. are only exemplified
in the context of their use for preparing preformed liposomes to form complexes with DNA called lipoplexes. </I></B>As explained by Dr.
Reyes in paragraph 10 of his Declaration submitted on October 22</FONT><FONT STYLE="color: #2F2F2F">,</FONT> <FONT STYLE="color: #0E0E0E">2014,
lipoplexes are electrostatic complexes in which little, if any, of the DNA payload is encapsulated within the preformed cationic liposomes.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.35pt; margin: 0pt 73pt 0pt 78.9pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 73pt 0pt 0"></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 18.25pt; margin: 0pt 73pt 0pt 78.55pt"><FONT STYLE="color: #0E0E0E">The Examiner
alleges that Unger <I>et al. </I>teaches that bioactive agents can be entrapped within the internal void of a lipid vesicle</FONT><FONT STYLE="color: #2F2F2F">,
</FONT><FONT STYLE="color: #0E0E0E">but <B><I>Applicants point out that Unger et al. still fails to exemplify encapsulation of nucleic
acid of any kind,</I></B> let alone mRNA.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 18.25pt; margin: 0pt 73pt 0pt 78.55pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 0 0pt 6.3pt; color: #0E0E0E">Exhibit 14 at p. 6 (emphases added).</P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 0 0pt 6.3pt; color: #0E0E0E"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.5pt; margin: 0pt 12.65pt 0pt 5.95pt"><FONT STYLE="color: #0E0E0E">The
Court is mindful of the Federal Circuit&rsquo;s caution that prosecution histories generally lack the clarity of specifications and thus
are less useful for claim construction purposes</FONT><FONT STYLE="color: #2F2F2F">.</FONT> <FONT STYLE="color: #0E0E0E">Nevertheless,
in this instance it appears the inventors drafted their claims to exclude mere aggregates/complexes</FONT><FONT STYLE="color: #2F2F2F">.</FONT>
<FONT STYLE="color: #0E0E0E">To the extent that language wasn&rsquo;t clear enough, the inventors then clearly and repeatedly touted their
distinction during prosecution, thereby</FONT> <FONT STYLE="color: #2F2F2F">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">demonstrating how
the inventor[s] understood the invention.</FONT><FONT STYLE="color: #2F2F2F">&rdquo;</FONT> <FONT STYLE="color: #0E0E0E"><I>Phillips,
</I>415 F</FONT><FONT STYLE="color: #424242">.</FONT><FONT STYLE="color: #0E0E0E">3d at 1317 (citations omitted). This <FONT STYLE="letter-spacing: -0.05pt">suggests
that &ldquo;the inventor[s] limited the invention in the </FONT>course of prosecution, making the claim scope narrower than it would otherwise
be.&rdquo; <FONT STYLE="font-size: 10pt"><I>Id.</I></FONT> (citations omitted).<SUP>8</SUP></FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.5pt; margin: 0pt 12.65pt 0pt 5.95pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="margin: 0pt 13.75pt 0pt 5.7pt; font-size: 10pt; text-align: justify; text-indent: 0.05pt"><FONT STYLE="font-size: 9pt">__________________&nbsp;</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.05pt; margin: 0pt 13.75pt 0pt 5.7pt"><FONT STYLE="font-size: 9pt; color: #0E0E0E"><SUP>8</SUP>
The Court emphasizes that it is not applying the doctrine of prosecution history estoppel here</FONT><FONT STYLE="font-size: 9pt; color: #424242">.</FONT>
<FONT STYLE="font-size: 9pt; color: #0E0E0E">It is only </FONT><FONT STYLE="font-size: 9pt; color: #2F2F2F">&ldquo;</FONT><FONT STYLE="font-size: 9pt; color: #0E0E0E">employ[ing]
the prosecut</FONT><FONT STYLE="font-size: 9pt; color: #2F2F2F">i</FONT><FONT STYLE="font-size: 9pt; color: #0E0E0E">on history to inform
the claim construction</FONT><FONT STYLE="font-size: 9pt; color: #424242">.</FONT><FONT STYLE="font-size: 9pt; color: #0E0E0E">&rdquo;
<I>Eye Therapies, LLC v. Slayback Pharma, LLC</I></FONT><I><FONT STYLE="font-size: 9pt; color: #424242">, </FONT></I><FONT STYLE="font-size: 9pt; color: #0E0E0E">141
F.4th 1264</FONT><FONT STYLE="font-size: 9pt; color: #2F2F2F">,</FONT> <FONT STYLE="font-size: 9pt; color: #0E0E0E">1271 n.5 (Fed. Cir</FONT><FONT STYLE="font-size: 9pt; color: #2F2F2F">.</FONT>
<FONT STYLE="font-size: 9pt; color: #0E0E0E">2025) (observing the distinction between estoppel analysis and claim construction)</FONT><FONT STYLE="font-size: 9pt; color: #424242">.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.05pt; margin: 0pt 13.75pt 0pt 5.7pt">&nbsp;</P>

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    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
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    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6966 </FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
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<TD STYLE="width: 80.05pt"></TD><TD STYLE="width: 36.35pt">5.</TD><TD>Extrinsic Evidence</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><I></I></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 31.55pt; margin: 0pt 10.65pt 0pt 8pt; color: #0E0E0E">As set forth above,
Plaintiffs submitted extrinsic evidence in the form of a Declaration of Dr. Thompson. The Court reviewed his Declaration and finds that
it is consistent with the intrinsic evidence considered by the Court. The Declaration is both persuasive and unrebutted by Defendants.
Accordingly, the Court finds that Dr. Thompson&rsquo;s Declaration further supports its construction.</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 31.55pt; margin: 0pt 10.65pt 0pt 8pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 31.35pt; margin: 0pt 11.05pt 0pt 7.8pt"><FONT STYLE="color: #0E0E0E">In sum,
for the reasons articulated, the Court concludes that </FONT><FONT STYLE="color: #262626">&ldquo;fully </FONT><FONT STYLE="color: #0E0E0E">encapsulated&rdquo;
in the claims of the</FONT> <FONT STYLE="color: #262626">&lsquo;651, &lsquo;359,</FONT> <FONT STYLE="color: #0E0E0E">and</FONT> <FONT STYLE="color: #262626">&lsquo;378</FONT>
<FONT STYLE="color: #0E0E0E">Patents should be construed to mean</FONT> <FONT STYLE="color: #262626">&ldquo;contained</FONT> <FONT STYLE="color: #0E0E0E">inside.&rdquo;</FONT></P>

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<TD STYLE="width: 43.75pt"></TD><TD STYLE="width: 17.75pt"><FONT STYLE="letter-spacing: -0.05pt">C.</FONT></TD><TD>Precision of &ldquo;mol %&rdquo; claim terms</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B></B></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.1pt; margin: 0pt 5.5pt 0pt 7.55pt; color: #0E0E0E"><FONT STYLE="letter-spacing: -0.05pt">The
Court next considers </FONT>the proper construction of &ldquo;mol %&rdquo; terms in the &lsquo;359 Patent. The parties disagree as to
the precision to be assigned to the mol % numbers recited by the claims. Plaintiffs propose that the mol % numbers be construed consistent
with general rules of significant figures and rounding. Plfs Op. Br. at 13-19. Under their proposal, for example, 50 mol% would be deemed
to encompass values from 49.5 to 50.4 mol %. A range would be treated thusly: 50% to 65 mol % would encompass 49.5 to 65.4 mol %.</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 9pt; margin: 0pt 5.5pt 0pt 0; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.95pt; margin: 0pt 11.7pt 0pt 7.35pt; color: #0E0E0E">Defendants argue
that, based on the prosecution history, the mol % numbers should instead <FONT STYLE="letter-spacing: -0.05pt">be treated as &ldquo;numerical
boundaries.&rdquo; Defs </FONT>Op. Br. 19-25. Under their proposal, a range of 50% to 65 mol % would be construed to mean no less than
50 and no more than 65 mol%. That is, a value of 49.9 or 65.1 would fall outside the claimed range.</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.95pt; margin: 0pt 11.7pt 0pt 7.35pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 35.75pt; margin: 0pt 12.2pt 0pt 7.35pt; color: #0E0E0E"><FONT STYLE="letter-spacing: -0.05pt">For
this dispute, the Court again has the benefit of the analysis</FONT> conducted by the Delaware district court in <FONT STYLE="font-size: 10pt"><I>Moderna.</I></FONT>
There, the defendants posed arguments similar to those advanced by</P>

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    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
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<P STYLE="font-size: 10pt; text-indent: 0.2pt; margin: 0pt 0 0pt 7.55pt; color: #0F0F0F">Defendants here.<SUP>9</SUP> The Delaware district
court rejected them in a well-reasoned and thorough opinion that this Court provides below:<SUP>10</SUP></P>

<P STYLE="font-size: 10pt; text-indent: 0.2pt; margin: 0pt 0 0pt 7.55pt; color: #0F0F0F">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.35pt; margin: 0pt 91pt 0pt 79.55pt"><FONT STYLE="color: #0F0F0F">Moderna
contends that</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0F0F0F">based on Plaintiffs</FONT><FONT STYLE="color: #282828">&rsquo;</FONT>
<FONT STYLE="color: #0F0F0F">explicit prosecution history disclaimer of the word </FONT><FONT STYLE="color: #282828">&ldquo;</FONT><FONT STYLE="color: #0F0F0F">about</FONT><FONT STYLE="color: #282828">,</FONT><FONT STYLE="color: #0F0F0F">&rdquo;
the ranges are numerically</FONT> <FONT STYLE="color: #282828">&ldquo;</FONT><FONT STYLE="color: #0F0F0F">exact</FONT><FONT STYLE="color: #282828">,&rdquo;
</FONT><FONT STYLE="color: #0F0F0F">meaning that the patent allows for no deviation above the high end or below the low end of the range.
Plaintiffs</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0F0F0F">on the other hand</FONT><FONT STYLE="color: #282828">,
</FONT><FONT STYLE="color: #0F0F0F">posit that the plain meaning of the numbers in its claims adheres to the standard scientific conventions
of significant figures and rounding. The Federal Circuit has emphasized that endpoints of a claimed range should not be given any more
precision than the claim language warrants. <FONT STYLE="text-decoration: underline solid">United States Philips Corp. v. Iwasaki Elec.
Co</FONT></FONT><FONT STYLE="text-decoration: underline solid; color: #282828">. </FONT><FONT STYLE="text-decoration: underline solid; color: #0F0F0F">Ltd</FONT><FONT STYLE="text-decoration: underline solid; color: #282828">.,</FONT>
<FONT STYLE="color: #0F0F0F">505 F.3d 1371</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0F0F0F">1377 (Fed</FONT><FONT STYLE="color: #282828">.
</FONT><FONT STYLE="color: #0F0F0F">Cir. 2007). &ldquo;In some <FONT STYLE="letter-spacing: -0.05pt">scientific contexts</FONT></FONT><FONT STYLE="color: #282828; letter-spacing: -0.05pt">,
</FONT><FONT STYLE="color: #0F0F0F; letter-spacing: -0.05pt">&lsquo;1</FONT><FONT STYLE="color: #282828; letter-spacing: -0.05pt">&rsquo;
</FONT><FONT STYLE="color: #0F0F0F; letter-spacing: -0.05pt">represents a less precise quantity </FONT><FONT STYLE="color: #0F0F0F">than
&lsquo;1.0</FONT><FONT STYLE="color: #282828">,&rsquo;</FONT> <FONT STYLE="color: #0F0F0F; letter-spacing: -0.05pt">and &lsquo;1</FONT><FONT STYLE="color: #282828; letter-spacing: -0.05pt">&rsquo;
</FONT><FONT STYLE="color: #0F0F0F; letter-spacing: -0.05pt">may encompass values such as 1.1 that </FONT><FONT STYLE="color: #282828">&lsquo;</FONT><FONT STYLE="color: #0F0F0F">1.0&rsquo;
may not.</FONT><FONT STYLE="color: #282828">&rdquo; </FONT><FONT STYLE="text-decoration: underline solid; color: #0F0F0F">Id</FONT><FONT STYLE="color: #444444">.</FONT>
<FONT STYLE="color: #0F0F0F">Under this &ldquo;standard scientific convention</FONT><FONT STYLE="color: #282828">&rdquo; </FONT><FONT STYLE="color: #0F0F0F">of
significant figures and rounding</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0F0F0F">a POSITA must look to the last
significant figure of a number and include values that round up and down to that number. <FONT STYLE="text-decoration: underline solid">See
AstraZeneca AB v</FONT></FONT><FONT STYLE="text-decoration: underline solid; color: #282828">.</FONT> <FONT STYLE="text-decoration: underline solid; color: #0F0F0F">Mylan
Pharms, Inc.</FONT><FONT STYLE="color: #282828">,</FONT> <FONT STYLE="color: #0F0F0F">19 F.4th 1325</FONT><FONT STYLE="color: #282828">,</FONT>
<FONT STYLE="color: #0F0F0F">1329</FONT><FONT STYLE="color: #282828">-</FONT><FONT STYLE="color: #0F0F0F">30 (Fed. Cir</FONT><FONT STYLE="color: #282828">.</FONT>
<FONT STYLE="color: #0F0F0F">2021). For example, the number</FONT> <FONT STYLE="color: #282828">&ldquo;</FONT><FONT STYLE="color: #0F0F0F">9</FONT><FONT STYLE="color: #282828">.</FONT><FONT STYLE="color: #0F0F0F">1&rdquo;
would encompass values between 9.05 and 9</FONT><FONT STYLE="color: #444444">.</FONT><FONT STYLE="color: #0F0F0F">14</FONT><FONT STYLE="color: #282828">,
</FONT><FONT STYLE="color: #0F0F0F">while the number 9.10 would encompass more specific values between 9.095 and 9.104</FONT><FONT STYLE="color: #282828">.</FONT>
<FONT STYLE="color: #0F0F0F">Similarly</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0F0F0F">the number </FONT><FONT STYLE="color: #282828">&ldquo;</FONT><FONT STYLE="color: #0F0F0F">9</FONT><FONT STYLE="color: #282828">&rdquo;
</FONT><FONT STYLE="color: #0F0F0F">would encompass 8</FONT><FONT STYLE="color: #282828">.</FONT><FONT STYLE="color: #0F0F0F">5 through
9.4</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0F0F0F">while &ldquo;9.0</FONT><FONT STYLE="color: #282828">&rdquo;</FONT>
<FONT STYLE="color: #0F0F0F">would encompass 8.95 through 9.04</FONT><FONT STYLE="color: #282828">.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.35pt; margin: 0pt 91pt 0pt 79.55pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.5pt; margin: 0pt 91pt 0pt 79.25pt; color: #0F0F0F">At the time the parties
submitted their claim construction briefing, controlling case law reflected that the application of the rules of significant figures and
rounding varied on a case-by-case basis. See <U>Par Pharm, Inc. v. Eagle Pharms, Inc.</U>, 44 F.4th 1379, 1382-83 (Fed. Cir. 2022) (affirming
construction where patent claiming a pH range of 3.7-3.9 was deemed to actually encompass a range of 3.65- 3.94); <U>San Huan New Materials
High Tech, Inc. v. Int&rsquo;l Trade Comm&rsquo; n</U>, 161 F.3d 1347, 1361 (Fed. Cir. 1998) (affirming judgment of infringement where
the asserted claim recited a range of 30% to 36% of chemical compound TRE, and the accused product had up to 36.45% TRE, and concluding
that it &ldquo;was not shown to be error, legal or scientific, for the Commission to recognize these limits of accuracy, and to round
the measured weight percentages to the nearest integer.&rdquo;); <U>Vifor Fresenius Med. Care Renal Pharm Ltd. v. Teva Pharms USA, Inc.</U>,
623 F. Supp. 3d 389, 416-17 (D. Del. 2022)</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.5pt; margin: 0pt 91pt 0pt 79.25pt; color: #0F0F0F">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="margin: 0pt 0"></P>

<P STYLE="margin: 0pt 35.05pt 0pt 7.35pt; font-size: 10pt; text-align: justify; text-indent: -0.15pt">___________________________&nbsp;&nbsp;</P>

<P STYLE="margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: -0.15pt; margin: 0pt 35.05pt 0pt 7.35pt"><FONT STYLE="font-size: 9pt; color: #282828; letter-spacing: -0.05pt"><SUP>9</SUP></FONT>
<FONT STYLE="font-size: 9pt; color: #0F0F0F">Defendants attempt to distinguish their position from the one advanced by the defendants
in <I>Moderna</I></FONT><I><FONT STYLE="font-size: 9pt; color: #282828">, </FONT></I><FONT STYLE="font-size: 9pt; color: #0F0F0F">but
the Court finds their arguments unpersuas</FONT><FONT STYLE="font-size: 9pt; color: #282828">i</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">ve</FONT><FONT STYLE="font-size: 9pt; color: #595959">.</FONT>
<FONT STYLE="font-size: 9pt; color: #0F0F0F"><I>Se</I></FONT><I><FONT STYLE="font-size: 9pt; color: #282828">e</FONT></I> <FONT STYLE="font-size: 9pt; color: #0F0F0F">Defs
Resp. Br. at 22</FONT><FONT STYLE="font-size: 9pt; color: #444444">.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: -0.15pt; margin: 0pt 35.05pt 0pt 7.35pt"><FONT STYLE="font-size: 9pt"></FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.2pt; margin: 0pt 11.65pt 0pt 7.3pt"><FONT STYLE="font-size: 9pt; color: #0F0F0F"><SUP>10</SUP>
The <I>Moderna </I>Opinion addresses U.S</FONT><FONT STYLE="font-size: 9pt; color: #595959">. </FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">Patent
No</FONT><FONT STYLE="font-size: 9pt; color: #444444">. </FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">8</FONT><FONT STYLE="font-size: 9pt; color: #282828">,</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">058</FONT><FONT STYLE="font-size: 9pt; color: #282828">,</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">069
(&lsquo;069 Patent). The </FONT><FONT STYLE="font-size: 9pt; color: #282828">&lsquo;</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">359
Patent in this case is a <FONT STYLE="letter-spacing: -0.05pt">continuation of the &lsquo;069 Patent. The <I>Moderna </I></FONT>court</FONT><FONT STYLE="font-size: 9pt; color: #282828">&rsquo;</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">s
decision expl</FONT><FONT STYLE="font-size: 9pt; color: #282828">i</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">citly states that
its con</FONT><FONT STYLE="font-size: 9pt; color: #282828">s</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">truction regarding the
<FONT STYLE="letter-spacing: -0.05pt">precision of the mol % t</FONT></FONT><FONT STYLE="font-size: 9pt; color: #282828; letter-spacing: -0.05pt">e</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F; letter-spacing: -0.05pt">rms
applies to </FONT><FONT STYLE="font-size: 9pt; color: #282828; letter-spacing: -0.05pt">&lsquo;</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F; letter-spacing: -0.05pt">069
Patent and </FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">several patents within the same family</FONT><FONT STYLE="font-size: 9pt; color: #282828">,
</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">including the </FONT><FONT STYLE="font-size: 9pt; color: #282828">&lsquo;</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">359
Patent. 2024 WL 1434526</FONT><FONT STYLE="font-size: 9pt; color: #282828">,</FONT> <FONT STYLE="font-size: 9pt; color: #0F0F0F">at</FONT>
<FONT STYLE="font-size: 9pt; color: #282828">*</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">4 n.4</FONT><FONT STYLE="font-size: 9pt; color: #444444">.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.2pt; margin: 0pt 11.65pt 0pt 7.3pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
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<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.3pt; margin: 0pt 83.6pt 0pt 79.25pt"><FONT STYLE="color: #0E0E0E">(applying
basic rounding principles to a pH range between 2.5 and 3.4); <FONT STYLE="text-decoration: underline solid">Johnson Matthey
Inc</FONT></FONT><FONT STYLE="text-decoration: underline solid; color: #262626">. </FONT><FONT STYLE="text-decoration: underline solid; color: #0E0E0E">v.
Noven Pharms</FONT><FONT STYLE="text-decoration: underline solid; color: #262626">., </FONT><FONT STYLE="text-decoration: underline solid; color: #0E0E0E">Inc</FONT><FONT STYLE="text-decoration: underline solid; color: #262626">.</FONT><FONT STYLE="color: #0E0E0E">,
No. 07-cv-260, 2009 WL 2208214</FONT><FONT STYLE="color: #262626">, </FONT><FONT STYLE="color: #0E0E0E">at *5 (E.D</FONT><FONT STYLE="color: #4F4F4F">. </FONT><FONT STYLE="color: #0E0E0E">Tex.
July 21</FONT><FONT STYLE="color: #262626">, </FONT><FONT STYLE="color: #0E0E0E">2009) (</FONT><FONT STYLE="color: #262626">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">[T]he
parties agree that a person of ordinary skill in the art would regard such disclosure as incorporating generally accepted principles
of rounding, such that numbers ranging from 40.5 to 41.4 would be rounded to 41, and numbers ranging from 41.5 to 42.4 would be
rounded to 42 when comparing a measured melting point to the asserted claims</FONT><FONT STYLE="color: #262626">.</FONT><FONT STYLE="color: #0E0E0E">&rdquo;)</FONT><FONT STYLE="color: #262626">; </FONT><FONT STYLE="text-decoration: underline solid; color: #0E0E0E">but
see AstraZeneca AB v. Mylan Pharms. Inc.</FONT><FONT STYLE="color: #262626">,</FONT> <FONT STYLE="color: #0E0E0E">19 F.4th 1325,
1329-32 (Fed. Cir. 2021) (noting that within the context of the particular claim, specification</FONT><FONT STYLE="color: #262626">,</FONT> <FONT STYLE="color: #0E0E0E">and
prosecution history which touted the superior stability of formulation within the concentration of &ldquo;0.001%&rdquo; meant
precisely 0.001% with onl</FONT><FONT STYLE="color: #262626">y </FONT><FONT STYLE="color: #0E0E0E">minor</FONT> <FONT STYLE="color: #262626">v</FONT><FONT STYLE="color: #0E0E0E">ariations&mdash;<I>i</I></FONT><I><FONT STYLE="color: #262626">.</FONT><FONT STYLE="color: #0E0E0E">e</FONT></I><FONT STYLE="color: #4F4F4F">.</FONT> <FONT STYLE="color: #0E0E0E">0.00095%
to 0</FONT><FONT STYLE="color: #262626">.</FONT><FONT STYLE="color: #0E0E0E">00104%&mdash; as opposed to normal rounding of 0.0005%
to 0.0014%); <FONT STYLE="text-decoration: underline solid">Noven Pharms, Inc. v. Amneal Pharms LLC</FONT></FONT><FONT STYLE="color: #262626">,</FONT> <FONT STYLE="color: #0E0E0E">Nos</FONT><FONT STYLE="color: #262626">.</FONT> <FONT STYLE="color: #0E0E0E">18-cv-699,
18-cv-758, 2019 WL 1102681</FONT><FONT STYLE="color: #262626">,</FONT> <FONT STYLE="color: #0E0E0E">at *4 (D. Del. Mar.
8</FONT><FONT STYLE="color: #262626">,</FONT> <FONT STYLE="color: #0E0E0E">2019) (finding that term</FONT> <FONT STYLE="color: #262626">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">coat
weight of greater than 10 <FONT STYLE="letter-spacing: -0.05pt">m</FONT><FONT STYLE="letter-spacing: 0.2pt">g</FONT></FONT><FONT STYLE="color: #262626; letter-spacing: -0.35pt">/</FONT><FONT STYLE="color: #0E0E0E; letter-spacing: -0.05pt">c</FONT><FONT STYLE="color: #0E0E0E; letter-spacing: -0.65pt">m<SUP>2</SUP></FONT> <FONT STYLE="color: #0E0E0E; letter-spacing: -0.05pt">wa</FONT><FONT STYLE="color: #0E0E0E">s
not <FONT STYLE="letter-spacing: -0.05pt">subjec</FONT>t <FONT STYLE="letter-spacing: -0.05pt">t</FONT>o a <FONT STYLE="letter-spacing: -0.05pt">significan</FONT>t
digits <FONT STYLE="letter-spacing: -0.05pt">a</FONT>n</FONT><FONT STYLE="color: #262626; letter-spacing: -0.05pt">a</FONT><FONT STYLE="color: #0E0E0E; letter-spacing: -0.05pt">lysis </FONT><FONT STYLE="color: #0E0E0E">because
the claims recited a range unbounded by</FONT> <FONT STYLE="color: #262626">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">an
unambiguous lower end&rdquo;)</FONT><FONT STYLE="color: #262626">; </FONT><FONT STYLE="text-decoration: underline solid; color: #0E0E0E">Aventis
Pharms S.A</FONT><FONT STYLE="text-decoration: underline solid; color: #4F4F4F">. </FONT><FONT STYLE="text-decoration: underline solid; color: #0E0E0E">v</FONT><FONT STYLE="text-decoration: underline solid; color: #262626">. </FONT><FONT STYLE="text-decoration: underline solid; color: #0E0E0E">Amphstar
Pharms., Inc.,</FONT> <FONT STYLE="color: #0E0E0E">Nos. 03-cv-887</FONT><FONT STYLE="color: #262626">,</FONT> <FONT STYLE="color: #0E0E0E">04-cv-333</FONT><FONT STYLE="color: #262626">,</FONT> <FONT STYLE="color: #0E0E0E">2004
WL 5700629, at *7 (C</FONT><FONT STYLE="color: #262626">.</FONT><FONT STYLE="color: #0E0E0E">D</FONT><FONT STYLE="color: #262626">.</FONT> <FONT STYLE="color: #0E0E0E">Cal.
Oct. 22</FONT><FONT STYLE="color: #262626">, </FONT><FONT STYLE="color: #0E0E0E">2004) (Construing numerical limitations with no
modifications by approximation or otherwise because ranges and degrees reinforce the use of precise values where the patentee
repeatedly emphasi</FONT><FONT STYLE="color: #262626">z</FONT><FONT STYLE="color: #0E0E0E">ed the criticality of the claimed ranges
to overcome prior art rejections).</FONT></P>

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<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.2pt; margin: 0pt 84.15pt 0pt 78.95pt"><FONT STYLE="color: #0E0E0E">Following
the claim construction briefing</FONT><FONT STYLE="color: #262626">,</FONT> <FONT STYLE="color: #0E0E0E">but before the <FONT STYLE="text-decoration: underline solid">Markman</FONT>
hearing</FONT><FONT STYLE="color: #262626">, </FONT><FONT STYLE="color: #0E0E0E">the Federal Circuit more squarely addressed the issue
of whether number ranges are subject to precise reading. In <FONT STYLE="text-decoration: underline solid">Actelion Pharmaceuticals LTD
v</FONT></FONT><FONT STYLE="text-decoration: underline solid; color: #262626">. </FONT><FONT STYLE="text-decoration: underline solid; color: #0E0E0E">Mylan
Pharmaceuticals Inc</FONT><FONT STYLE="text-decoration: underline solid; color: #262626">.</FONT><FONT STYLE="color: #0E0E0E">, 85 F.4th
1167 (Fed</FONT><FONT STYLE="color: #262626">. </FONT><FONT STYLE="color: #0E0E0E">Cir. 2023)</FONT><FONT STYLE="color: #262626">, </FONT><FONT STYLE="color: #0E0E0E">the
sole question before the Court was the meaning of &ldquo;a pH of 13 or higher&rdquo; in the context of the asserted patents. <FONT STYLE="text-decoration: underline solid">Id</FONT>.
at 1170</FONT><FONT STYLE="color: #262626">. </FONT><FONT STYLE="color: #0E0E0E">The district court construed the claim term as including
values that rounded to the ones place&mdash;<I>i.e.</I>, a range of 12</FONT><FONT STYLE="color: #262626">.</FONT><FONT STYLE="color: #0E0E0E">5
or higher&mdash;based on the rules of significant figures</FONT><FONT STYLE="color: #262626">,</FONT> <FONT STYLE="color: #0E0E0E">while
the defendant argued that the claim term created an absolute floor at 13</FONT><FONT STYLE="color: #262626">,</FONT> <FONT STYLE="color: #0E0E0E">beneath
which the pH could not fall</FONT><FONT STYLE="color: #262626">. </FONT><FONT STYLE="text-decoration: underline solid; color: #0E0E0E">Id</FONT><FONT STYLE="color: #0E0E0E">.
The Federal Circuit found no merit to defendant&rsquo;s argument that because the claim language involved a range, it was not subject
to the rules of rounding and held that </FONT><FONT STYLE="color: #262626">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">there is no blanket
rule that ranges</FONT><FONT STYLE="color: #262626">, </FONT><FONT STYLE="color: #0E0E0E">or specifically open-ended ranges, must foreclose
rounding.&rdquo; <FONT STYLE="text-decoration: underline solid">Id</FONT></FONT><FONT STYLE="color: #262626">. </FONT><FONT STYLE="color: #0E0E0E">at
1171. The Court also declined to find that the absence of approximation language-such as </FONT><FONT STYLE="color: #262626">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">about&rdquo;
or </FONT><FONT STYLE="color: #262626">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">approximately&rdquo; &mdash;implies that the numerical
range is exact. <FONT STYLE="text-decoration: underline solid">Id</FONT>. Instead, the Court </FONT><FONT STYLE="color: #262626">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">reject[ed]
any invitation to create a bright-line rule-either that language like &lsquo;precisely</FONT><FONT STYLE="color: #262626">&rsquo; </FONT><FONT STYLE="color: #0E0E0E">or
</FONT><FONT STYLE="color: #262626">&lsquo;</FONT><FONT STYLE="color: #0E0E0E">exactly</FONT><FONT STYLE="color: #262626">&rsquo; </FONT><FONT STYLE="color: #0E0E0E">is
always needed to avoid rounding or that the lack of approximation language</FONT><FONT STYLE="color: #262626">,</FONT> <FONT STYLE="color: #0E0E0E">even
when it may be found elsewhere in the claims</FONT><FONT STYLE="color: #262626">,</FONT></P>

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    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
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<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 83.65pt 0pt 79.4pt"><FONT STYLE="color: #0F0F0F">dictates a precise value.&rdquo;
<FONT STYLE="text-decoration: underline solid">Id</FONT>. Finding that the proper construction of the claim language could not be resolved
without reference to extrinsic evidence</FONT><FONT STYLE="color: #0E0E0E">&mdash;</FONT><FONT STYLE="color: #0F0F0F"><I>i.e., </I>the
background knowledge of a person of ordinary skill </FONT><FONT STYLE="color: #242424">in </FONT><FONT STYLE="color: #0F0F0F">the art</FONT><FONT STYLE="color: #0E0E0E">&mdash;</FONT><FONT STYLE="color: #0F0F0F">the
Court remanded for review of such evidence, which the district court had not previously considered. <FONT STYLE="text-decoration: underline solid">Id</FONT>.
at 1172-74.</FONT></P>

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<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.25pt; margin: 0pt 83.6pt 0pt 79.15pt"><FONT STYLE="color: #0F0F0F">Guided
by this framework</FONT><FONT STYLE="color: #343434">, </FONT><FONT STYLE="color: #0F0F0F">I now tum to the claim language before me.
Using the &lsquo;069 patent as exemplary, claim 1 discloses a range of </FONT><FONT STYLE="color: #242424">&ldquo;from </FONT><FONT STYLE="color: #0F0F0F">50
mol <FONT STYLE="font-size: 10pt">% </FONT>to 65 mol <FONT STYLE="font-size: 10pt">% </FONT>of the total lipid present in the particle.&rdquo;
As noted in <FONT STYLE="text-decoration: underline solid">Actelion,</FONT> the absence of language of approximation or precision does
not dictate that the rules of rounding apply, and thus I tum to the specification. The specification of the </FONT><FONT STYLE="color: #242424">&lsquo;069
</FONT><FONT STYLE="color: #0F0F0F">patent states that </FONT><FONT STYLE="color: #242424">&ldquo;[i]n </FONT><FONT STYLE="color: #0F0F0F">one
aspect, the present invention provides lipid particles comprising: (a) one or more active agents or therapeutic agents; (b) one or more
cationic lipids comprising from <I>about </I>50 mol <FONT STYLE="font-size: 10pt">% </FONT>to <I>about </I>85 mol <FONT STYLE="font-size: 10pt">%
</FONT>of the total lipid present in the particle; (c) one or more non-cationic lipids comprising from <I>about </I>13 mol <FONT STYLE="font-size: 10pt">%
</FONT>to <I>about </I>49.5 mol <FONT STYLE="font-size: 10pt">% </FONT>of the total lipid present in the particle</FONT><FONT STYLE="color: #343434">;
</FONT><FONT STYLE="color: #0F0F0F">and (d) one or more conjugated lipids that inhibit aggregation of particles comprising from <I>about</I>
0.5 mol <FONT STYLE="font-size: 10pt">% </FONT>to <I>about </I>2 mol <FONT STYLE="font-size: 10pt">% </FONT>of the total lipid present
in the particle</FONT><FONT STYLE="color: #343434">.&rdquo; </FONT><FONT STYLE="color: #0F0F0F">(&lsquo;069 patent 3</FONT><FONT STYLE="color: #525252">:</FONT><FONT STYLE="color: #0F0F0F">10-
20 (emphasis added).)</FONT></P>

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<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.2pt; margin: 0pt 83.85pt 0pt 78.95pt"><FONT STYLE="color: #0F0F0F">Moderna
contends that the use of the word</FONT> <FONT STYLE="color: #242424">&ldquo;about&rdquo;</FONT> <FONT STYLE="color: #0F0F0F">in the specification
demonstrates that the inventors knew how to use words of approximation but intentionally chose not to in the claim language itself, meaning
that numerical precision is required</FONT><FONT STYLE="color: #525252">. </FONT><FONT STYLE="text-decoration: underline solid; color: #0F0F0F">See
Baxter Healthcare Corp</FONT><FONT STYLE="text-decoration: underline solid; color: #343434">. </FONT><FONT STYLE="text-decoration: underline solid; color: #0F0F0F">v.
Nevakar Injectables, Inc</FONT><FONT STYLE="text-decoration: underline solid; color: #343434">.,</FONT> <FONT STYLE="color: #0F0F0F">Nos</FONT><FONT STYLE="color: #343434">.
</FONT><FONT STYLE="color: #0F0F0F">21-cv- 1184, 21-cv-1186</FONT><FONT STYLE="color: #343434">,</FONT> <FONT STYLE="color: #0F0F0F">2023
WL 4175261, at</FONT> <FONT STYLE="color: #242424">*15</FONT> <FONT STYLE="color: #0F0F0F">(D. Del. June 26, 2023) (noting that </FONT><FONT STYLE="color: #242424">&ldquo;[t]he
</FONT><FONT STYLE="color: #0F0F0F">Federal Circuit has made clear that when a patent includes qualifying language for certain claim
limitations but omits it from others</FONT><FONT STYLE="color: #343434">,</FONT> <FONT STYLE="color: #0F0F0F">the claims without such
approximation should be construed with numerical precision. </FONT><FONT STYLE="color: #525252">. </FONT><FONT STYLE="color: #242424">.
</FONT><FONT STYLE="color: #0F0F0F">. This is because a POSITA would understand that the patentees knew how to express ambiguity in claim
language when they so desired.&rdquo;) (citing <FONT STYLE="text-decoration: underline solid">Jeneric/Pentron, Inc</FONT></FONT><FONT STYLE="text-decoration: underline solid; color: #343434">.</FONT>
<FONT STYLE="text-decoration: underline solid; color: #0F0F0F">v. Dillon Co., Inc.,</FONT> <FONT STYLE="color: #0F0F0F">205 F.3d 1377,
1381 (Fed. Cir. 2000)); <FONT STYLE="text-decoration: underline solid">see also Takeda Pharm</FONT></FONT><FONT STYLE="text-decoration: underline solid; color: #525252">.
</FONT><FONT STYLE="text-decoration: underline solid; color: #0F0F0F">Co. v. Zydus Pharms</FONT><FONT STYLE="text-decoration: underline solid; color: #343434">.
</FONT><FONT STYLE="text-decoration: underline solid; color: #0F0F0F">USA, Inc.,</FONT> <FONT STYLE="color: #0F0F0F">743 F.3d 1359, 1365
(Fed. Cir. 2014) (&ldquo;[H]ad the inventors desired the average particle diameter to include a margin of error, they could easily have
included the word &lsquo;about&rsquo; in the claim <FONT STYLE="letter-spacing: -0.05pt">language. </FONT>In the absence of their decision
not to do so, however, we will not take it upon ourselves to rewrite the claim that way.&rdquo;).</FONT></P>

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<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 84.55pt 0pt 78.75pt"><FONT STYLE="color: #0F0F0F">Notably</FONT><FONT STYLE="color: #343434">,
</FONT><FONT STYLE="color: #0F0F0F">both cases cited by Moderna involved situations where the words of approximation appeared at various
points in the claim language itself. Here</FONT><FONT STYLE="color: #343434">, </FONT><FONT STYLE="color: #0F0F0F">the words of approximation
are only in the specification. And, in <FONT STYLE="text-decoration: underline solid">Actelion,</FONT> the Federal Circuit expressly</FONT></P>

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    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
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<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.25pt; margin: 0pt 83.6pt 0pt 79.45pt"><FONT STYLE="color: #0E0E0E">declined
to create a bright-line rule that the absence of approximation language in claim language dictates a precise value. As such</FONT><FONT STYLE="color: #282828">,
</FONT><FONT STYLE="color: #0E0E0E">the presence of the word &ldquo;about&rdquo; in the specification without its similar inclusion in
the claim language could support a <FONT STYLE="letter-spacing: -0.05pt">construction that eliminates a broader range of approximation</FONT></FONT><FONT STYLE="color: #282828; letter-spacing: -0.05pt">,</FONT>
<FONT STYLE="color: #0E0E0E">but it does not preclude application of the scientific convent</FONT><FONT STYLE="color: #282828">i</FONT><FONT STYLE="color: #0E0E0E">on
of rounding.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.25pt; margin: 0pt 83.6pt 0pt 79.45pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.1pt; margin: 0pt 83.85pt 0pt 79.15pt"><FONT STYLE="color: #0E0E0E">In
fact</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0E0E0E">the specification substantiates Plaintiffs&rsquo;
construction. In both the portion of the specification cited above and in other sections of specification</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0E0E0E">the
inventors demonstrated that the</FONT><FONT STYLE="color: #282828">y </FONT><FONT STYLE="color: #0E0E0E">knew how to use additional
significant numbers past a decimal point. For example, the inventors used 49.5%</FONT><FONT STYLE="color: #282828">,</FONT> <FONT STYLE="color: #0E0E0E">meaning
that under the rules of rounding</FONT><FONT STYLE="color: #282828">,</FONT> <FONT STYLE="color: #0E0E0E">the claimed number would
be limited to 49.45% to 49</FONT><FONT STYLE="color: #282828">.</FONT><FONT STYLE="color: #0E0E0E">54</FONT>%<FONT STYLE="color: #282828">. </FONT><FONT STYLE="color: #0E0E0E">Similarly</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0E0E0E">in
other portions of the specification, specifically Table 2</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0E0E0E">the
inventors depicted some of the whole numbers with trailing zeros, such as &ldquo;27.0&rdquo; (giving a rounding range of 26.95-
27.04),</FONT> <FONT STYLE="color: #282828">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">64</FONT><FONT STYLE="color: #282828">.</FONT><FONT STYLE="color: #0E0E0E">0</FONT><FONT STYLE="color: #282828">&rdquo;</FONT> <FONT STYLE="color: #0E0E0E">(giving
a rounding range of 63.95- 64</FONT><FONT STYLE="color: #282828">.</FONT><FONT STYLE="color: #0E0E0E">04),</FONT> <FONT STYLE="color: #282828">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">1.0&rdquo;
(giving a rounding range of 0.95- 1.04)</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0E0E0E">and
&ldquo;7</FONT><FONT STYLE="color: #4F4F4F">.</FONT><FONT STYLE="color: #0E0E0E">0</FONT><FONT STYLE="color: #282828">&rdquo; </FONT><FONT STYLE="color: #0E0E0E">(giving
a rounding range of 6.95- 7</FONT><FONT STYLE="color: #282828">.</FONT><FONT STYLE="color: #0E0E0E">04). Had the inventors intended
to not rely on the rules of rounding and significant figures</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0E0E0E">they
would not need to have written the whole numbers in Table 2 with any trailing zeroes</FONT><FONT STYLE="color: #282828">,</FONT> <FONT STYLE="color: #0E0E0E"><I>i.e.,</I>
they would have written them as</FONT> <FONT STYLE="color: #282828">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">27&rdquo;</FONT><FONT STYLE="color: #282828">,
&ldquo;</FONT><FONT STYLE="color: #0E0E0E">64&rdquo;</FONT><FONT STYLE="color: #282828">, &ldquo;</FONT><FONT STYLE="color: #0E0E0E">1&rdquo;,
and</FONT> <FONT STYLE="color: #282828">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">7&rdquo;.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.15pt; margin: 0pt 84.25pt 0pt 79pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.4pt; margin: 0pt 84.3pt 0pt 78.75pt"><FONT STYLE="color: #0E0E0E">While
the specification is instructive on the proper construction</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0E0E0E">it
is not conclusive. Accordingly</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0E0E0E">I look to the last piece of intrinsic
evidence</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0E0E0E">the prosecution history, which </FONT><FONT STYLE="color: #282828">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">can
often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited
the invention in the course of prosecution</FONT><FONT STYLE="color: #282828">, </FONT><FONT STYLE="color: #0E0E0E">making the claim scope
narrower than it would otherwise be</FONT><FONT STYLE="color: #282828">.&rdquo;</FONT> <FONT STYLE="text-decoration: underline solid; color: #0E0E0E">Phillips</FONT><FONT STYLE="color: #282828">,</FONT>
<FONT STYLE="color: #0E0E0E">415 F</FONT><FONT STYLE="color: #282828">.</FONT><FONT STYLE="color: #0E0E0E">3d at 1317.</FONT></P>

<P STYLE="margin: 0pt 84.3pt 0pt 78.75pt; font-size: 10pt; text-align: justify; text-indent: 0.4pt"><FONT STYLE="color: #0E0E0E">&nbsp;</FONT></P>

<P STYLE="margin: 0pt 84.3pt 0pt 78.75pt; font-size: 10pt; text-align: justify; text-indent: 0.4pt"><FONT STYLE="color: #0E0E0E">During the prosecution of the earliest Molar Ratio patent&mdash;the </FONT><FONT STYLE="color: #282828">&lsquo;</FONT><FONT STYLE="color: #0E0E0E">069
patent&mdash;the original range claims included words of approximation&mdash;<I>e</I></FONT><I><FONT STYLE="color: #4F4F4F">.</FONT><FONT STYLE="color: #0E0E0E">g.</FONT></I><FONT STYLE="color: #282828">,
<FONT STYLE="font-size: 10pt"><I>&ldquo;</I></FONT></FONT><I><FONT STYLE="font-size: 10pt; color: #0E0E0E">about</FONT></I> <FONT STYLE="color: #0E0E0E">50
mol % to <FONT STYLE="font-size: 10pt"><I>about</I></FONT> 65 mol %.</FONT><FONT STYLE="color: #282828">&rdquo;</FONT> <FONT STYLE="color: #0E0E0E">(JA001801.)
The Patent Examiner rejected these claims over the prior art</FONT><FONT STYLE="color: #3D3D3D">, </FONT><FONT STYLE="color: #0E0E0E">U.S.
Pat. Pub. No. 2006</FONT><FONT STYLE="color: #282828">/</FONT><FONT STYLE="color: #0E0E0E">0008910 (</FONT><FONT STYLE="color: #282828">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">MacLachlan</FONT><FONT STYLE="color: #282828">&rdquo;</FONT><FONT STYLE="color: #0E0E0E">),
which taught ranges for the four lipid components that overlapped with the claimed ranges as follows:</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.4pt; margin: 0pt 84.3pt 0pt 78.75pt"></P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 84.75pt 0pt 78.65pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 75%; background-color: white; border-collapse: collapse; font-size: 10pt; margin-left: 78.75pt">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 33%; border: Black 1pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Lipid Component</B></FONT></TD>
    <TD STYLE="width: 34%; border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Claim 1 as Amended</B></FONT></TD>
    <TD STYLE="width: 33%; border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>US 2006/0008910*</B></FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; text-align: center"><FONT STYLE="font-size: 10pt">Cationic Lipid</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; text-align: center"><FONT STYLE="font-size: 10pt">50-65 mol %</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; text-align: center"><FONT STYLE="font-size: 10pt">&ldquo;2-60, 5-50, 10-45, 20-40, 30 mol%&rdquo;</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; text-align: center"><FONT STYLE="font-size: 10pt">Phospholipid</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; text-align: center"><FONT STYLE="font-size: 10pt">4-10 mol %</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; text-align: center"><FONT STYLE="font-size: 10pt">&ldquo;5-90 mol%&rdquo;</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; text-align: center"><FONT STYLE="font-size: 10pt">Cholesterol</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; text-align: center"><FONT STYLE="font-size: 10pt">30-40 mol %</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; text-align: center"><FONT STYLE="font-size: 10pt">&ldquo;20-55 mol %&rdquo;</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; text-align: center"><FONT STYLE="font-size: 10pt">Conjugated Lipid</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; text-align: center"><FONT STYLE="font-size: 10pt">0.5-2 mol %</FONT></TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; text-align: center"><FONT STYLE="font-size: 10pt">&ldquo;1-20 mol %&rdquo;</FONT></TD></TR>
  </TABLE>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 84.75pt 0pt 78.65pt">&nbsp;</P>

<P STYLE="margin: 0pt 0"></P>

<P STYLE="margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.15pt; margin: 0pt 85.15pt 0pt 78.25pt"><FONT STYLE="color: #0E0E0E">(JA00515</FONT><FONT STYLE="color: #282828">.</FONT><FONT STYLE="color: #0E0E0E">)
The examiner noted that the relative amount of each component in the claims &ldquo;read on a broad range of amounts because <FONT STYLE="letter-spacing: -0.05pt">of
the term </FONT></FONT><FONT STYLE="color: #282828; letter-spacing: -0.05pt">&lsquo;</FONT><FONT STYLE="color: #0E0E0E; letter-spacing: -0.05pt">comprising
about.</FONT><FONT STYLE="color: #282828; letter-spacing: -0.05pt">&rsquo; &rdquo;</FONT> <FONT STYLE="color: #0E0E0E">The examiner went
on to explain that</FONT> <FONT STYLE="color: #282828">&ldquo;</FONT><FONT STYLE="color: #0E0E0E">[t]he applicants do not provide a definition
of the term in the</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.15pt; margin: 0pt 85.15pt 0pt 78.25pt">&nbsp;</P>

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    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 20 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">697</FONT>1</TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
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<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 0 0pt 79.25pt"><FONT STYLE="color: #0E0E0E">specification</FONT><FONT STYLE="color: #595959">.</FONT> <FONT STYLE="color: #0E0E0E">Thus</FONT><FONT STYLE="color: #383838">,</FONT> <FONT STYLE="color: #0E0E0E">&lsquo;comprising
about&rsquo; could embrace an amount +/- 10, 20, 30 mol % of a lipid component.&rdquo; (JA00494</FONT><FONT STYLE="color: #383838">.</FONT><FONT STYLE="color: #0E0E0E">)</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 0 0pt 79.4pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.25pt; margin: 0pt 83.15pt 0pt 79pt"><FONT STYLE="color: #0E0E0E">To overcome
the rejection</FONT><FONT STYLE="color: #383838">, </FONT><FONT STYLE="color: #0E0E0E">Plaintiffs amended the claims to remove <FONT STYLE="letter-spacing: -0.05pt">the
word </FONT></FONT><FONT STYLE="color: #242424; letter-spacing: -0.05pt">&ldquo;about&rdquo; </FONT><FONT STYLE="color: #0E0E0E; letter-spacing: -0.05pt">from
the claims </FONT><FONT STYLE="color: #0E0E0E">and </FONT><FONT STYLE="color: #242424">&ldquo;point[</FONT><FONT STYLE="color: #0E0E0E">ed]
out that claim 1 as presently amended recites narrow ranges for each of the lipid components compared to </FONT><FONT STYLE="color: #383838">.</FONT><FONT STYLE="color: #0E0E0E">..
Maclachlan.&rdquo; Plaintiffs also explained that </FONT><FONT STYLE="color: #242424">&ldquo;the</FONT> <FONT STYLE="color: #0E0E0E">present
invention is based, in part</FONT><FONT STYLE="color: #383838">, </FONT><FONT STYLE="color: #0E0E0E">on the surprising discovery that
1:57 SNALP formulations provide <B><I>new and unexpected </I></B>results&rdquo; and that SNALP formulations having <U>increased</U> amounts
of cationic lipid present in the particle, provide <FONT STYLE="letter-spacing: -0.1pt"><B><I>unexpectedly superior advantage</I></B><I>s</I></FONT></FONT><FONT STYLE="color: #383838; letter-spacing: -0.1pt">.</FONT><FONT STYLE="color: #0E0E0E; letter-spacing: -0.1pt">&rdquo;
(JA510-12</FONT><FONT STYLE="color: #383838; letter-spacing: -0.1pt">,</FONT> <FONT STYLE="color: #0E0E0E; letter-spacing: -0.05pt">JA515-16
(emphasis in original).) Following the</FONT> <FONT STYLE="color: #0E0E0E">removal of the word</FONT> <FONT STYLE="color: #242424">&ldquo;about,&rdquo;</FONT>
<FONT STYLE="color: #0E0E0E">the examiner allowed the claims to issue. (JA00524.) In the related IPR proceedings, Plaintiffs repeated
the arguments about the importance of the narrowed ranges. (JA002294, JA2565, JA002802.)</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.25pt; margin: 0pt 83.15pt 0pt 79pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.55pt; margin: 0pt 83.9pt 0pt 78.7pt"><FONT STYLE="color: #0E0E0E">Although
the specification appears to favor Plaintiffs&rsquo; construction, it does not conclusively resolve whether the endpoints on the claimed
ranges are subject to rounding. In such a case, the Federal Circuit has instructed the reviewing court to examine the extrinsic evidence.
<FONT STYLE="text-decoration: underline solid">Actelion,</FONT> 85 F.4th at 1173-1174 (directing district court to consider extrinsic
evidence to determine </FONT><FONT STYLE="color: #242424">&ldquo;how </FONT><FONT STYLE="color: #0E0E0E">many significant figures &lsquo;a
pH of 13&rsquo; has or what it would mean for a number&mdash;either for a pH value or for the concentration of hydrogen ions&mdash;to
have zero significant figures.&rdquo;).</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.55pt; margin: 0pt 83.9pt 0pt 78.7pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 84.2pt 0pt 78.9pt; color: #0E0E0E"><FONT STYLE="letter-spacing: -0.05pt">Here,
the sole extrinsic evidence </FONT>of record of how a POSITA would understand the claim language is offered by Plaintiffs&rsquo; expert,
Dr. David Thompson, who opined that:</P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 84.2pt 0pt 78.9pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.4pt; margin: 0pt 101.9pt 0pt 96.5pt"><FONT STYLE="color: #0E0E0E">[S]ignificant
figures and rounding are standard scientific conventions that the POS[IT]A would have been aware of and would have applied in interpreting
the claims of the Lipid Composition Patent. With respect to the recited mol % ranges, the POS[IT]A would have known that lipid concentrations
could be experimentally determined, for example using high-performance liquid chromatography (&ldquo;HPLC&rdquo;)... Accordingly, the
POS[IT]A would have known that mol % values, as with measured values more generally in the field, are subject to numerical uncertainty,
and would <FONT STYLE="letter-spacing: -0.05pt">have interpreted</FONT> the claimed mol % ranges</FONT><FONT STYLE="color: #383838">,</FONT>
<FONT STYLE="color: #0E0E0E">in the context of the patent specification, using the standard convention of significant figures and rounding.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.4pt; margin: 0pt 101.9pt 0pt 96.5pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.2pt; margin: 0pt 84.6pt 0pt 78.45pt; color: #0E0E0E">(JA00431.) In support
of this opinion, Dr. Thompson engages in an extensive review of the claim language, the specification, and the prosecution history. (JA00431-439.)</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.2pt; margin: 0pt 84.6pt 0pt 78.45pt; color: #0E0E0E">&nbsp;</P>

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    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 21 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6972</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
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<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-indent: 81pt; margin: 0pt 0">&hellip;</P>

<P STYLE="font-size: 10pt; text-indent: 81pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-indent: 81pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.25pt; margin: 0pt 83.7pt 0pt 79.15pt"><FONT STYLE="color: #0E0E0E">Given
both Dr. Thompson&rsquo;s credentials and his thorough explanation for his opinion</FONT><FONT STYLE="color: #343434">, </FONT><FONT STYLE="color: #0E0E0E">I
find that this extrinsic evidence weighs in favor of Plaintiffs&rsquo; construction.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.25pt; margin: 0pt 83.7pt 0pt 79.15pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-indent: 81pt; margin: 0pt 0">&hellip;</P>

<P STYLE="font-size: 10pt; text-indent: 81pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.45pt; margin: 0pt 83.6pt 0pt 78.85pt"><FONT STYLE="color: #0E0E0E">In
sum, I am persuaded by Plaintiffs&rsquo; construction-that the recited &ldquo;mol %&rdquo; ranges are understood to encompass their standard
variation based on the number of significant figures recited in the claim</FONT><FONT STYLE="color: #343434">. </FONT><FONT STYLE="color: #0E0E0E">As
noted above, the Federal Circuit has cautioned against interpreting &ldquo;endpoints of the claimed range with greater precision than
the claim language warrants</FONT><FONT STYLE="color: #343434">.</FONT><FONT STYLE="color: #0E0E0E">&rdquo; <FONT STYLE="text-decoration: underline solid">U.S</FONT></FONT><FONT STYLE="text-decoration: underline solid; color: #525252">.
</FONT><FONT STYLE="text-decoration: underline solid; color: #0E0E0E">Philips Corp</FONT><FONT STYLE="text-decoration: underline solid; color: #343434">.,</FONT>
<FONT STYLE="color: #0E0E0E">505 F.3d at 1377. The specification shows that Plaintiffs knew how to use trailing zeros to add more precision
and explicitly did not do so with the ranges at issue. Moderna has pointed to no evidence that variations in the tenths of a mol % would
have any impact on the functionality of the claimed invention such that I should construe the ranges with more specificity. And Moderna
has not established that Plaintiffs&rsquo; removal of the word </FONT><FONT STYLE="color: #242424">&ldquo;about&rdquo; </FONT><FONT STYLE="color: #0E0E0E">constituted
a clear and unmistakable disclaimer of the rules of rounding. Indeed</FONT><FONT STYLE="color: #343434">,</FONT> <FONT STYLE="color: #0E0E0E">the
removal of the word &ldquo;about&rdquo; appears to have been done only to satisfy the examiner&rsquo;s concern that the claim language
</FONT><FONT STYLE="color: #242424">&ldquo;read </FONT><FONT STYLE="color: #0E0E0E">on a broad range of amounts&rdquo; and &ldquo;could
embrace an amount +/-10</FONT><FONT STYLE="color: #343434">,</FONT> <FONT STYLE="color: #0E0E0E">20</FONT><FONT STYLE="color: #343434">,
</FONT><FONT STYLE="color: #0E0E0E">30 mol % of a lipid component</FONT><FONT STYLE="color: #343434">,&rdquo;</FONT> <FONT STYLE="color: #0E0E0E">not
to eliminate the minor variations associated with rounding. Finally</FONT><FONT STYLE="color: #343434">,</FONT> <FONT STYLE="color: #0E0E0E">the
sole extrinsic evidence of record comes from Plaintiffs&rsquo; expert, Dr. Thompson, who opines that a POSITA would understand that the
rules of rounding and significant figures apply to the claimed ranges.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.2pt; margin: 0pt 83.9pt 0pt 78.95pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.2pt; margin: 0pt 83.9pt 0pt 78.95pt; color: #0E0E0E">For all the foregoing
reasons, I will adopt Plaintiffs&rsquo; construction of the first disputed term, as follows: &ldquo;<B>___ mol % of the total lipid present
in the particle.&rdquo; The recited &ldquo;mol % ranges are <FONT STYLE="letter-spacing: -0.05pt">understood</FONT> to encompass their
standard variation based on the number of significant figures recited in the claim.&rdquo;</B></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.2pt; margin: 0pt 83.9pt 0pt 78.95pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><B></B></P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 0 0pt 0.1in; color: #0E0E0E"><I>Moderna</I> Opinion, 2024 WL 1434526, at *8-13
(emphases in original).</P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 0 0pt 0.1in; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.3pt; margin: 0pt 12pt 0pt 7.05pt"><FONT STYLE="color: #0E0E0E">The Court
finds highly persuasive the <I>Moderna </I>court&rsquo;s thorough reasoning as to the precision of mol % terms recited by the claims of
the </FONT><FONT STYLE="color: #242424">&lsquo;359 </FONT><FONT STYLE="color: #0E0E0E">Patent. Accordingly, the Court adopts the same
construction proposed by Plaintiffs here</FONT><FONT STYLE="color: #343434">, </FONT><FONT STYLE="color: #0E0E0E">as follows: </FONT><FONT STYLE="color: #242424">&ldquo;the
</FONT><FONT STYLE="color: #0E0E0E">recited mol % ranges are understood to encompass their standard variation based on the significant
figures recited in the claim.&rdquo;</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.3pt; margin: 0pt 12pt 0pt 7.05pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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    <TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 22 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6973</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
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<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-bottom: 0pt; color: #161616"><TR STYLE="vertical-align: top">
<TD STYLE="width: 45pt"></TD><TD STYLE="width: 20.65pt"><FONT STYLE="letter-spacing: -0.05pt">D.</FONT></TD><TD>&ldquo;consisting essentially of&rsquo;&rsquo;</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.55pt; margin: 0pt 1pt 0pt 8.45pt"><FONT STYLE="color: #161616">Finally,
the </FONT><FONT STYLE="color: #262626">Court </FONT><FONT STYLE="color: #161616">considers the proper construction of </FONT><FONT STYLE="color: #262626">&ldquo;consisting
</FONT><FONT STYLE="color: #161616">essentially of&rsquo; in the</FONT> <FONT STYLE="color: #262626">&lsquo;3</FONT><FONT STYLE="color: #161616">78
patent. Relevant to that construction, </FONT><FONT STYLE="color: #262626">the </FONT><FONT STYLE="color: #161616">parties dispute the
</FONT><FONT STYLE="color: #262626">&ldquo;basic </FONT><FONT STYLE="color: #161616">and novel properties&rdquo; of the invention claimed
</FONT><FONT STYLE="color: #262626">in </FONT><FONT STYLE="color: #161616">the </FONT><FONT STYLE="color: #262626">&lsquo;378 </FONT><FONT STYLE="color: #161616">patent.
Plaintiffs argue that the basic and novel properties are the combination and concentration of the lipid components recited in the claims.
Plfs Op. Br. at 25-27. They argue the prosecution history of the </FONT><FONT STYLE="color: #262626">&lsquo;378 </FONT><FONT STYLE="color: #161616">Patent
supports their </FONT><FONT STYLE="color: #262626">position</FONT><FONT STYLE="color: #050505">. </FONT><FONT STYLE="color: #161616"><I>(Id.
</I>at 26-27.)</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.55pt; margin: 0pt 1pt 0pt 8.45pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.75pt; margin: 0pt 0 0pt 7.8pt"><FONT STYLE="color: #161616">Defendants
criticize Plaintiffs&rsquo; proposal as circular: the novel <I>properties </I>of an inventive combination must be more than the combination
itself. Defendants propose more detailed basic and novel properties. In their view, the relevant properties are: (1) </FONT><FONT STYLE="color: #3D3D3D">&ldquo;</FONT><FONT STYLE="color: #161616">increased
activity of the encapsulated nucleic </FONT><FONT STYLE="color: #262626">acid&rdquo;; </FONT><FONT STYLE="color: #161616">(2) </FONT><FONT STYLE="color: #262626">&ldquo;improved
</FONT><FONT STYLE="color: #161616">tolerability of the formulations in </FONT><FONT STYLE="color: #262626">vivo&rdquo;; </FONT><FONT STYLE="color: #161616">(3)
</FONT><FONT STYLE="color: #262626">&ldquo;significant</FONT> <FONT STYLE="color: #161616">increase in therapeutic index&rdquo;</FONT><FONT STYLE="color: #3D3D3D">;
</FONT><FONT STYLE="color: #161616">and (4) </FONT><FONT STYLE="color: #262626">&ldquo;stability </FONT><FONT STYLE="color: #161616">in
circulation&rdquo; </FONT><FONT STYLE="color: #262626">&ldquo;when </FONT><FONT STYLE="color: #161616">compared to formulations having
less than 50 mol </FONT><FONT STYLE="color: #262626">% cationic </FONT><FONT STYLE="color: #161616">lipid.&rdquo; Defs Op. Br. at 27.
In support of their position regarding features (1)-(4), Defendants rely on language from the Detailed Description of the Invention. <I>(Id.</I>
at 27-28.) In support of their proposed comparison to formulations having less than 50 mol </FONT><FONT STYLE="color: #262626">%</FONT>
<FONT STYLE="color: #161616; letter-spacing: -0.05pt">cationic lipid</FONT><FONT STYLE="color: #3D3D3D; letter-spacing: -0.05pt">, </FONT><FONT STYLE="color: #161616; letter-spacing: -0.05pt">Defendants
cite </FONT><FONT STYLE="color: #262626; letter-spacing: -0.05pt">separate </FONT><FONT STYLE="color: #161616; letter-spacing: -0.05pt">language
from the Detailed Description </FONT><FONT STYLE="color: #161616">and argue that the Court should find that it is an </FONT><FONT STYLE="color: #3D3D3D">&ldquo;</FONT><FONT STYLE="color: #161616">unlisted
feature&rdquo; whose presence would </FONT><FONT STYLE="color: #3D3D3D">&ldquo;</FONT><FONT STYLE="color: #161616">materially affect[s]
the basic and</FONT> <FONT STYLE="color: #050505">no</FONT><FONT STYLE="color: #262626">vel</FONT> <FONT STYLE="color: #161616">properties
of the invention.</FONT><FONT STYLE="color: #3D3D3D">&rdquo;</FONT> <FONT STYLE="color: #161616"><I>(Id.</I> at 29.)</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.75pt; margin: 0pt 0 0pt 7.8pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 79.8pt"></TD><TD STYLE="width: 35.8pt"><FONT STYLE="color: #161616"><I>1.</I></FONT></TD><TD><FONT STYLE="color: #262626"><I>General</I></FONT><I> <FONT STYLE="color: #161616">Legal Principles of</FONT> <FONT STYLE="color: #3D3D3D">&ldquo;C</FONT><FONT STYLE="color: #161616">onsisting
Essentially Of</FONT><FONT STYLE="color: #3D3D3D">&rdquo;</FONT></I></TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.25pt; margin: 0pt 0 0pt 7.3pt"><FONT STYLE="color: #161616">&ldquo;Consisting
essentially of&rsquo; is a transition phrase often </FONT><FONT STYLE="color: #050505">used </FONT><FONT STYLE="color: #161616">to signal
a partially open claim. <I>PPG Indus</I></FONT><I><FONT STYLE="color: #3D3D3D">. </FONT><FONT STYLE="color: #161616">v. Guardian Indus.,
</FONT></I><FONT STYLE="color: #161616">156 F.3d 1351, 1354 (Fed. Cir. 1998). It serves as a middle ground between closed-ended claims
using the phrase </FONT><FONT STYLE="color: #3D3D3D">&ldquo;</FONT><FONT STYLE="color: #161616">consisting of&rsquo; and open-ended claims
using the phrase </FONT><FONT STYLE="color: #262626">&ldquo;comprising</FONT><FONT STYLE="color: #050505">.</FONT><FONT STYLE="color: #262626">&rdquo;</FONT>
<FONT STYLE="color: #161616"><I>Id.; </I></FONT><I><FONT STYLE="color: #262626">AK Steel </FONT><FONT STYLE="color: #161616">Corp. </FONT><FONT STYLE="color: #262626">v.
</FONT><FONT STYLE="color: #161616">Sollac </FONT><FONT STYLE="color: #262626">&amp; Ugine, </FONT></I><FONT STYLE="color: #161616">344
F.3d 1234</FONT><FONT STYLE="color: #3D3D3D">, </FONT><FONT STYLE="color: #161616">1239 (Fed</FONT><FONT STYLE="color: #3D3D3D">. </FONT><FONT STYLE="color: #161616">Cir.
2003). A drafter will typically employ the phrase</FONT> <FONT STYLE="color: #262626">&ldquo;consisting</FONT> <FONT STYLE="color: #161616">essentially
of&rsquo; before</FONT> <FONT STYLE="color: #262626">&ldquo;(a)</FONT> <FONT STYLE="color: #161616">a list of</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.25pt; margin: 0pt 0 0pt 7.3pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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<TABLE BORDER="0" CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; border-collapse: collapse"><TR STYLE="vertical-align: middle"><TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 23 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6974</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
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<P STYLE="margin: 0pt 0; font-size: 10pt">&nbsp;</P>


<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.05pt; margin: 0pt 11.55pt 0pt 7.3pt"><FONT STYLE="color: #0F0F0F">ingredients
when dealing with a composition claim, or (b) a series of steps when dealing with a process claim</FONT><FONT STYLE="color: #424242">.</FONT><FONT STYLE="color: #262626">&rdquo;
</FONT><FONT STYLE="color: #0F0F0F"><I>HZNP Medicines LLC v</I></FONT><I><FONT STYLE="color: #424242">. </FONT><FONT STYLE="color: #0F0F0F">Actavis
Lab&rsquo;ys UT Inc., </FONT></I><FONT STYLE="color: #0F0F0F">940 F.3d 680, 692-693 (Fed. Cir. 2019) (citation omitted). Thusly, &ldquo;the
drafter signals that the invention necessarily includes the listed ingredients [but] is open to unlisted ingredients that do not materially
affect the basic and novel properties of the invention.&rdquo; <I>Id</I></FONT><I><FONT STYLE="color: #424242">. </FONT></I><FONT STYLE="color: #0F0F0F">Put
differently, </FONT><FONT STYLE="color: #262626">&ldquo;[t]he </FONT><FONT STYLE="color: #0F0F0F">phrase &lsquo;consisting essentially
<I>of</I> . . . permit[s] inclusion of components not listed in the claim, provided that they do not</FONT> <FONT STYLE="color: #262626">&lsquo;materially</FONT>
<FONT STYLE="color: #0F0F0F">affect the basic and novel properties of the invention.&rsquo;&rdquo; <I>AK Steel,</I> 344 F.3d at 1239.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.05pt; margin: 0pt 11.55pt 0pt 7.3pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top">
<TD STYLE="width: 79.1pt"></TD><TD STYLE="width: 36.2pt"><I>2.</I></TD><TD STYLE="text-align: justify"><I>The Claim Language</I></TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><I></I></P>

<P STYLE="font-size: 10pt; text-indent: 36.35pt; margin: 0pt 0 0pt 6.75pt"><FONT STYLE="color: #0F0F0F">Claim 1 is the only independent
claim in the</FONT> <FONT STYLE="color: #262626">&lsquo;378</FONT> <FONT STYLE="color: #0F0F0F">Patent and the only claim that uses the</FONT>
<FONT STYLE="color: #262626">&ldquo;consisting</FONT> <FONT STYLE="color: #0F0F0F">essentially of&rsquo; transitional phrase</FONT><FONT STYLE="color: #424242">:</FONT></P>

<P STYLE="font-size: 10pt; text-indent: 36.35pt; margin: 0pt 0 0pt 6.75pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 0 0pt 1.1in"><FONT STYLE="color: #0F0F0F">1</FONT><FONT STYLE="color: #424242">.</FONT>
<FONT STYLE="color: #0F0F0F">A nucleic acid-lipid particle consisting essentially of</FONT><FONT STYLE="color: #424242">:</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 0 0pt 1.1in"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top">
<TD STYLE="width: 79.05pt"></TD><TD STYLE="width: 16.25pt"><FONT STYLE="letter-spacing: -0.05pt">(a)</FONT></TD><TD STYLE="text-align: justify">an RNA;</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top">
<TD STYLE="width: 79.05pt"></TD><TD STYLE="width: 16.95pt"><FONT STYLE="letter-spacing: -0.05pt">(b)</FONT></TD><TD STYLE="text-align: justify">a cationic lipid having a protonatable tertiary amine;</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 79.05pt; text-align: right"></TD><TD STYLE="width: 16.95pt"><FONT STYLE="font-size: 10pt; letter-spacing: -0.05pt">(c)</TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">a mixture of a phospholipid and cholesterol of from 30 mol
% to 55 mol % of the total lipid present in the particle, wherein the phospholipid consists of from 3 mol </FONT>% <FONT STYLE="font-size: 10pt">to
15 mol </FONT>% <FONT STYLE="font-size: 10pt">of the total lipid present in the particle; and</FONT></TD>
</TR></TABLE>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.2pt; margin: 0pt 83.7pt 0pt 78.9pt; color: #0F0F0F"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top">
<TD STYLE="width: 78.85pt"></TD><TD STYLE="width: 18.15pt"><FONT STYLE="letter-spacing: -0.05pt">(d)</FONT></TD><TD STYLE="text-align: justify">a polyethyleneglycol (PEG)-lipid conjugate consisting of from 0.1 mol % to 2 mol % of the total lipid present in the particle.</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 79.05pt; text-align: right"></TD><TD STYLE="width: 16.95pt"></TD><TD STYLE="text-align: justify"></TD>
</TR></TABLE>

<P STYLE="font-size: 10pt; text-align: justify; margin: 0pt 0 0pt 78.95pt; color: #0F0F0F">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.55pt; margin: 0pt 12.2pt 0pt 6.9pt"><FONT STYLE="color: #0F0F0F">&lsquo;378
Patent 93:16-26. The various dependent claims do not recite any further limitations with respect to the cationic lipid limitation (b)</FONT><FONT STYLE="color: #424242">.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.55pt; margin: 0pt 12.2pt 0pt 6.9pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; font-style: italic; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top">
<TD STYLE="width: 78.9pt"></TD><TD STYLE="width: 36.15pt">3.</TD><TD STYLE="text-align: justify">The Specification</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><I></I></P>

<P STYLE="font-size: 10pt; text-indent: 36.05pt; margin: 0pt 0 0pt 6.8pt; color: #0F0F0F"><FONT STYLE="letter-spacing: -0.05pt">Defendants</FONT>
focus on the following passage, which is the first paragraph from the Detailed Description of the Invention:</P>

<P STYLE="font-size: 10pt; text-indent: 36.05pt; margin: 0pt 0 0pt 6.8pt; color: #0F0F0F">&nbsp;</P>

<P STYLE="margin: 0pt 0 0pt 6.8pt; font-size: 10pt; text-indent: 36.05pt; color: #0F0F0F"></P>

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<TABLE BORDER="0" CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: middle"><TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 24 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
<TR STYLE="vertical-align: middle">
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6975</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
</TABLE>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: -0.05pt; margin: 0pt 82.35pt 0pt 80.3pt; color: #0E0E0E"><FONT STYLE="font-size: 10pt"><B><I>The
present invention</I></B> is based, in part, <B><I>upon the surprising discovery </I></B>that lipid particles comprising <B><I>from about
50 mol </I></B>% <B><I>to about 85 mol</I></B></FONT> % <FONT STYLE="font-size: 10pt"><B><I>of a cationic lipid,</I></B> from about 13
mol % to about <FONT STYLE="color: #0E0E0E">49.5 mol % of a non-cationic lipid, and from about 0.5 mol % to about 2 mol % of a lipid
conjugate provide advantages when used for the in vitro or in vivo delivery of an active agent</FONT><FONT STYLE="color: #343434">, </FONT><FONT STYLE="color: #0E0E0E">such
as a therapeutic nucleic acid (e.g</FONT><FONT STYLE="color: #444444">., </FONT><FONT STYLE="color: #0E0E0E">an interfering RNA). In
particular, as illustrated by the Examples herein, <B><I>the present invention </I></B>provides stable nucleic acid-lipid particles (SNALP)
<B><I>that advantageously impart increased activity of the encapsulated nucleic acid </I></B>(e.g., an interfering RNA such as siRNA)
and <B><I>improved tolerability of the formulations in vivo, </I></B>resulting in a <B><I>significant increase in the therapeutic index</I></B>
as compared to nucleic acid-lipid particle compositions previously described. Additionally</FONT><FONT STYLE="color: #343434">, </FONT><FONT STYLE="color: #0E0E0E">the
SNALP of the</FONT> <FONT STYLE="color: #1F1F1F">invention </FONT><FONT STYLE="color: #0E0E0E">are <B><I>stable in circulation, </I></B>e.g.,
resistant to degradation by nucleases in serum, and are substantially non-toxic to mammals such as humans.</FONT></FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.75pt; margin: 0pt 82.4pt 0pt 79.6pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.9pt; margin: 0pt 0.15in 0pt 7.55pt"><FONT STYLE="color: #1F1F1F">&lsquo;378
</FONT><FONT STYLE="color: #0E0E0E">Patent 6:6-24 (emphases added). Defendants argue that the emphasized language represents the goal
of the invention and the features that distinguish the invention from the prior art</FONT><FONT STYLE="color: #444444">.</FONT> <FONT STYLE="color: #0E0E0E">Defs
Op</FONT><FONT STYLE="color: #444444">. </FONT><FONT STYLE="color: #0E0E0E">Br. at 28</FONT><FONT STYLE="color: #444444">.</FONT> <FONT STYLE="color: #0E0E0E">As
Plaintiffs point out</FONT><FONT STYLE="color: #343434">, </FONT><FONT STYLE="color: #0E0E0E">however, the first sentence of this passage
describes an invention that differs from the one recited in Claim 1. Importantly, the sentence describes lipid particles comprising from
about 50 mol % to about 85 mol % of a cationic lipid,&rdquo; whereas Claim 1 recites only &ldquo;a cationic lipid having a protonatable
tertiary amine&rdquo; without a numerical range. The Court therefore agrees with Plaintiffs and finds that the first sentence of the paragraph
is inapplicable and cannot support Defendants&rsquo; proposal to insert the 50 mol% language into the claim construction. <SUP>11</SUP></FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.9pt; margin: 0pt 0.15in 0pt 7.55pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="margin: 0pt 13.1pt 0pt 7.15pt; font-size: 10pt; text-align: justify; text-indent: 0.25pt">__________________________</P>

<P STYLE="margin: 0pt 0"></P>

<P STYLE="margin: 0pt 13.1pt 0pt 7.15pt; font-size: 10pt; text-align: justify; text-indent: 0.25pt"><FONT STYLE="font-size: 9pt; color: #0E0E0E; letter-spacing: -0.05pt"><SUP>11</SUP>
The </FONT><FONT STYLE="font-size: 9pt; color: #1F1F1F; letter-spacing: -0.05pt">Examples </FONT><FONT STYLE="font-size: 9pt; color: #0E0E0E">section
of the specification also states that </FONT><FONT STYLE="font-size: 9pt; color: #343434">&ldquo;</FONT><FONT STYLE="font-size: 9pt; color: #0E0E0E">[t]hose
of skill in the art will readily recognize a variety of noncritical parameters which can be changed or</FONT> <FONT STYLE="font-size: 9pt; color: #1F1F1F">modified</FONT>
<FONT STYLE="font-size: 9pt; color: #0E0E0E">to yield essentially the same results</FONT><FONT STYLE="font-size: 9pt; color: #343434">.&rdquo;</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.25pt; margin: 0pt 13.1pt 0pt 7.15pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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<TR STYLE="vertical-align: middle"><TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 25 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
<TR STYLE="vertical-align: middle">
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6976</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
</TABLE>

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<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.3pt; margin: 0pt 11.55pt 0pt 7.15pt; color: #0E0E0E">The remaining language
of the cited paragraph is a different matter. The first sentence refers only to the &ldquo;present invention,&rdquo; not a composition
with a particular concentration of cationic lipid.<SUP>12</SUP> Again, that sentence states as follows:</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.3pt; margin: 0pt 11.55pt 0pt 7.15pt; color: #0E0E0E">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.05pt; margin: 0pt 83.55pt 0pt 1.1in"><FONT STYLE="color: #0E0E0E">In particular</FONT><FONT STYLE="color: #313131">,</FONT>
<FONT STYLE="color: #0E0E0E">as illustrated by the Examples herein, <B><I>the present invention </I></B>provides stable nucleic acid-lipid
particles (SNALP) <B><I>that advantageously impart increased activity of the encapsulated nucleic acid </I></B>(e.g., an interfering RNA
such as siRNA) and <B><I>improved tolerability of the formulations in vivo, </I></B>resulting in a significant increase in the therapeutic
index as compared to nucleic acid-lipid particle compositions previously described</FONT><FONT STYLE="color: #494949">.</FONT> <FONT STYLE="color: #0E0E0E">Additionally</FONT><FONT STYLE="color: #313131">,</FONT>
<FONT STYLE="color: #0E0E0E">the SNALP of the invention are <B><I>stable in circulation, </I></B>e.g.</FONT><FONT STYLE="color: #313131">,
</FONT><FONT STYLE="color: #0E0E0E">resistant to degradation by nucleases in serum, and are substantially non-toxic to mammals such as
humans</FONT><FONT STYLE="color: #313131">.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.05pt; margin: 0pt 83.55pt 0pt 1.1in">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.6pt; margin: 0pt 11.55pt 0pt 6.25pt"><FONT STYLE="color: #0E0E0E">The Court
finds that the highlighted language does support part of Defendants&rsquo; position insofar as the sentence identifies two &ldquo;advantageous[]&rdquo;
properties of the inventive nucleic acid-lipid particles: &ldquo;increased activity of the encapsulated nucleic acid&rdquo; and &ldquo;improved
tolerability of the formulations in vivo.&rdquo; The Court therefore agrees that the specification supports their inclusion among the
</FONT><FONT STYLE="color: #232323">&ldquo;basic </FONT><FONT STYLE="color: #0E0E0E">and novel properties&rdquo; of the invention</FONT><FONT STYLE="color: #494949">.</FONT>
<FONT STYLE="color: #0E0E0E">The Court disagrees, however, that &ldquo;increased therapeutic index&rdquo; is a basic and novel property.
The sentence articulates this feature as the result, or consequence, of a combined increase in activity and tolerability, not a property
in and of its own. The Court further finds that the third sentence favors including &ldquo;stable in circulation&rdquo; among the basic
and novel properties of the claimed invention. Importantly, there is explicit support for this notion elsewhere in the specification.
In relevant part, the Brief Summary of the Invention broadly states: <FONT STYLE="font-size: 10pt"><B><I>&ldquo;The present invention
provides novel, serum-stable lipid <FONT STYLE="letter-spacing: -0.05pt">particles</FONT></I></B></FONT> <FONT STYLE="letter-spacing: -0.05pt">comprising
one or more active agents or therapeutic agents,</FONT> methods of making the lipid</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.6pt; margin: 0pt 11.55pt 0pt 6.25pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="margin: 0pt 22.4pt 0pt 5.95pt; font-size: 10pt; text-align: justify; text-indent: 0.35pt">_________________________</P>

<P STYLE="margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.35pt; margin: 0pt 22.4pt 0pt 5.95pt"><FONT STYLE="font-size: 9pt; color: #0E0E0E"><SUP>12</SUP>
The Court recognizes that the second </FONT><FONT STYLE="font-size: 9pt; color: #232323">sentence </FONT><FONT STYLE="font-size: 9pt; color: #0E0E0E">begins
with &ldquo;in particular</FONT><FONT STYLE="font-size: 9pt; color: #313131">&rdquo; </FONT><FONT STYLE="font-size: 9pt; color: #0E0E0E">but
finds that this segue does not limit the description in the second </FONT><FONT STYLE="font-size: 9pt; color: #232323">sentence </FONT><FONT STYLE="font-size: 9pt; color: #0E0E0E">to
the invention identified in the first sentence. The first sentence notes that the invention</FONT> <FONT STYLE="font-size: 9pt; color: #232323">is
</FONT><FONT STYLE="font-size: 9pt; color: #0E0E0E">only based</FONT> <FONT STYLE="font-size: 9pt; color: #232323">&ldquo;in</FONT> <FONT STYLE="font-size: 9pt; color: #0E0E0E">part&rdquo;
on its specifically recited combination.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.35pt; margin: 0pt 22.4pt 0pt 5.95pt">&nbsp;</P>

<P STYLE="margin: 0pt 22.4pt 0pt 5.95pt; font-size: 10pt; text-align: justify; text-indent: 0.35pt"></P>

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<TABLE BORDER="0" CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: middle"><TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 26 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
<TR STYLE="vertical-align: middle">
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6977</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
</TABLE>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-indent: -0.05pt; margin: 0pt 5.85pt 0pt 7.8pt"><FONT STYLE="color: #0F0F0F">particles, and methods of
delivering and/or administering the lipid particles (e</FONT><FONT STYLE="color: #424242">.</FONT><FONT STYLE="color: #0F0F0F">g., for
the treatment of a disease or disorder).&rdquo;<SUP>13</SUP> &lsquo;378 Patent 3:24-27.</FONT></P>

<P STYLE="font-size: 10pt; text-indent: -0.05pt; margin: 0pt 5.85pt 0pt 7.8pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; font-style: italic; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top">
<TD STYLE="width: 79.4pt"></TD><TD STYLE="width: 36.15pt">4.</TD><TD>The Prosecution History</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><I></I></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.4pt; margin: 0pt 11.35pt 0pt 7.05pt"><FONT STYLE="color: #0F0F0F">As noted,
Plaintiffs eschew the specification in favor of the prosecution history. During prosecution, Plaintiffs repeatedly touted the novelty
of the specific combination of the components as differing from what was taught by the prior art cited by the patent examiner. In short,
they maintain that the prosecution history demonstrates that the basic and novel properties of the claimed invention</FONT><FONT STYLE="color: #0E0E0E">&mdash;</FONT><FONT STYLE="color: #0F0F0F">the
specific listed ingredients</FONT><FONT STYLE="color: #0E0E0E">&mdash;</FONT><FONT STYLE="color: #0F0F0F">are the listed ingredients themselves.
As Defendants note, this is both problematically circular and ignores the specification. The specific combination of ingredients may be
the point of novelty in the context of patentability negotiations with the Patent Office</FONT><FONT STYLE="color: #424242">, </FONT><FONT STYLE="color: #0F0F0F">but
that does not necessarily circumscribe the </FONT><FONT STYLE="color: #242424">&ldquo;the </FONT><FONT STYLE="color: #0F0F0F">basic and
novel properties,&rdquo; particularly in the face of clear language in the specification.</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.4pt; margin: 0pt 11.35pt 0pt 7.05pt">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.15pt; margin: 0pt 12pt 0pt 6.8pt"><FONT STYLE="color: #0F0F0F">Accordingly,
the Court shall construe </FONT><FONT STYLE="color: #242424">&ldquo;consisting </FONT><FONT STYLE="color: #0F0F0F">essentially of&rdquo;
to mean </FONT><FONT STYLE="color: #242424">&ldquo;consisting </FONT><FONT STYLE="color: #0F0F0F">of only the listed ingredients and those
that do not materially affect the increased activity of the encapsulated nucleic acid and the improved tolerability of the formulations
in vivo, or the stability in circulation.&rdquo;</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 36.15pt; margin: 0pt 12pt 0pt 6.8pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; font-style: italic; margin-top: 0pt; margin-bottom: 0pt; color: #0F0F0F"><TR STYLE="vertical-align: top">
<TD STYLE="width: 78.4pt"></TD><TD STYLE="width: 36.3pt">5.</TD><TD>Extrinsic Evidence</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 42.45pt; color: #0F0F0F">The Court does not resort to extrinsic evidence because it finds
that the intrinsic record is clear.</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 6.6pt; color: #0F0F0F">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="margin: 0pt 12.95pt 0pt 6.2pt; font-size: 10pt; text-align: justify; text-indent: 0.35pt"><FONT STYLE="font-size: 9pt">______________________&nbsp;</FONT></P>

<P STYLE="font-size: 10pt; text-align: justify; text-indent: 0.35pt; margin: 0pt 12.95pt 0pt 6.2pt"><FONT STYLE="font-size: 9pt; color: #0F0F0F"><SUP>13</SUP>
Defendants did not propose that </FONT><FONT STYLE="font-size: 9pt; color: #242424">&ldquo;substantially </FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">non-toxic
to mammals&rdquo; be included among the basic and novel properties of the invention. Even </FONT><FONT STYLE="font-size: 9pt; color: #242424">if
</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">they had, the Court identified no broad support for that property in the specification
that was not limited to</FONT> <FONT STYLE="font-size: 9pt; color: #242424">&ldquo;certain</FONT> <FONT STYLE="font-size: 9pt; color: #0F0F0F">embodiments</FONT><FONT STYLE="font-size: 9pt; color: #424242">.</FONT><FONT STYLE="font-size: 9pt; color: #0F0F0F">&rdquo;</FONT></P>

<P STYLE="margin: 0pt 12.95pt 0pt 6.2pt; font-size: 10pt; text-align: justify; text-indent: 0.35pt"><FONT STYLE="font-size: 9pt; color: #0F0F0F">&nbsp;</FONT></P>

<P STYLE="margin: 0pt 12.95pt 0pt 6.2pt; font-size: 10pt; text-align: justify; text-indent: 0.35pt"><FONT STYLE="font-size: 9pt; color: #0F0F0F"></FONT></P>

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<P STYLE="margin: 0pt 12.95pt 0pt 6.2pt; font-size: 10pt; text-align: justify; text-indent: 0.35pt"></P>

<P STYLE="margin: 0pt 12.95pt 0pt 6.2pt; font-size: 10pt; text-align: justify; text-indent: 0.35pt"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="margin: 0pt 0; font-size: 10pt"></P>

<TABLE BORDER="0" CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: middle"><TD STYLE="font-size: 10pt; width: 20%"><FONT STYLE="color: Blue">Case 3:23-cv-01876-ZNQ-TJB&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 20%"><FONT STYLE="color: Blue">Document 246</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Filed 09/09/25</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right; width: 30%"><FONT STYLE="color: Blue">Page 27 of 27</FONT> <FONT STYLE="color: Blue">PageID:</FONT></TD></TR>
<TR STYLE="vertical-align: middle">
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt; text-align: right"><FONT STYLE="color: Blue">6978</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="color: Blue">&nbsp;</FONT></TD></TR>
</TABLE>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-bottom: 0pt; color: #0C0C0C"><TR STYLE="vertical-align: top">
<TD STYLE="width: 7.8pt"></TD><TD STYLE="width: 36.25pt"><FONT STYLE="letter-spacing: -0.05pt">V.</FONT></TD><TD>CONCLUSION</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font-size: 10pt"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-indent: 36.3pt; margin: 0pt 0 0pt 7.75pt; color: #0C0C0C">For the foregoing reasons, the Court will construe
the disputed and stipulated terms of the patents in suit in accordance with the table below. An appropriate Order will follow.</P>

<P STYLE="font-size: 10pt; text-indent: 36.3pt; margin: 0pt 0 0pt 7.75pt; color: #0C0C0C"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="2" STYLE="width: 100%; font-size: 10pt; border-collapse: collapse">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 38%; border: black 1pt solid; padding-left: 71.5pt; text-align: center; font-size: 10pt"><FONT STYLE="font-size: 10pt; color: #0C0C0C"><B>TERM</B></FONT></TD>
    <TD STYLE="width: 62%; border-top: black 1pt solid; border-right: black 1pt solid; border-bottom: black 1pt solid; padding-left: 67.55pt; font-size: 10pt"><FONT STYLE="font-size: 10pt; color: #0C0C0C"><B>COURT&rsquo;S CONSTRUCTION</B></FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid; border-left: black 1pt solid; padding-left: 5.7pt; font-size: 10pt"><FONT STYLE="font-size: 10pt; color: #212121">&ldquo;lipid</FONT> <FONT STYLE="font-size: 10pt; color: #0C0C0C">vesicle&rdquo;</FONT></TD>
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid">
    <P STYLE="font-size: 10pt; text-indent: -0.15pt; margin: 0pt 2.4pt 0pt 6.3pt"><FONT STYLE="color: #0C0C0C">&ldquo;any lipid composition
that can be used to deliver a compound including, but not limited to, liposomes, wherein an aqueous volume is encapsulated by an amphipathic
lipid bilayer; or wherein the lipids coat an <FONT STYLE="letter-spacing: -0.05pt">interior </FONT>comprising a large molecular component,
such as a plasmid, with a reduced aqueous interior; or lipid aggregates or micelles</FONT><FONT STYLE="color: #343434">, </FONT><FONT STYLE="color: #0C0C0C">wherein
the encapsulated component is contained within a relatively disordered lipid mixture&rdquo;</FONT></P>
    <P STYLE="font-size: 10pt; margin: 0pt 0 0pt 6.35pt; color: #0C0C0C"></P></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid; border-left: black 1pt solid; font-size: 10pt"><FONT STYLE="font-size: 10pt; color: #0C0C0C">&ldquo;fully encapsulated&rdquo;</FONT></TD>
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid; padding-left: 5.95pt; font-size: 10pt"><FONT STYLE="font-size: 10pt; color: #0C0C0C">&ldquo;contained inside&rdquo;</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid; border-left: black 1pt solid; font-size: 10pt"><FONT STYLE="font-size: 10pt; color: #212121">&ldquo;mol </FONT><FONT STYLE="font-size: 10pt; color: #0C0C0C">%&rdquo;</FONT></TD>
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid">
    <P STYLE="font-size: 10pt; text-indent: -0.4pt; margin: 0pt 0 0pt 6.1pt"><FONT STYLE="color: #343434">&ldquo;</FONT><FONT STYLE="color: #0C0C0C">the
recited mol % ranges are understood to encompass their standard variation based on the significant figures recited in the claim&rdquo;</FONT></P>
    <P STYLE="font-size: 10pt; text-indent: -0.05pt; margin: 0pt 0 0pt 6.15pt; color: #0C0C0C"></P></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid; border-left: black 1pt solid; font-size: 10pt"><FONT STYLE="font-size: 10pt; color: #212121">&ldquo;consisting </FONT><FONT STYLE="font-size: 10pt; color: #0C0C0C">essentially of&rsquo;</FONT></TD>
    <TD STYLE="border-right: black 1pt solid; border-bottom: black 1pt solid">
    <P STYLE="font-size: 10pt; text-indent: -0.35pt; margin: 0pt 8.15pt 0pt 6.05pt"><FONT STYLE="color: #212121">&ldquo;consisting</FONT>
<FONT STYLE="color: #0C0C0C">of only the listed ingredients and those that do not materially affect the increased activity of the encapsulated
nucleic acid and the improved tolerability of the formulations in vivo, or the stability in circulation&rdquo;</FONT></P>
    <P STYLE="font-size: 10pt; margin: 0pt 0 0pt 5.8pt; color: #0C0C0C"></P></TD></TR>
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<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

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<TR STYLE="vertical-align: top; text-align: left">
  <TD STYLE="width: 50%"><B>DATED:</B>
September 9, 2025</TD>
  <TD STYLE="width: 50%">&nbsp;<IMG SRC="sign1.jpg" ALT=""></TD></TR>
</TABLE>

<P STYLE="margin: 0pt 0; font-size: 10pt"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 7.1pt; color: #0C0C0C"></P>

<P STYLE="font-size: 10pt; margin: 0pt 0 0pt 7.1pt; color: #0C0C0C">&nbsp;</P>
<P STYLE="margin: 0; font-size: 10pt"><B></B></P>

<P STYLE="text-align: center; border-bottom: Black 4pt solid; margin-top: 0; margin-bottom: 0; font-size: 10pt">27</P>

<P STYLE="margin: 0; font-size: 10pt"></P>

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      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityAddressCityOrTown_lbl" xml:lang="en-US">Entity Address, City or Town</link:label>
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      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityAddressStateOrProvince_lbl" xml:lang="en-US">Entity Address, State or Province</link:label>
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      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_EntityAddressCountry" xlink:to="dei_EntityAddressCountry_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityAddressCountry_lbl" xml:lang="en-US">Entity Address, Country</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_EntityAddressPostalZipCode" xlink:label="dei_EntityAddressPostalZipCode" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_EntityAddressPostalZipCode" xlink:to="dei_EntityAddressPostalZipCode_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityAddressPostalZipCode_lbl" xml:lang="en-US">Entity Address, Postal Zip Code</link:label>
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      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_CountryRegion" xlink:to="dei_CountryRegion_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_CountryRegion_lbl" xml:lang="en-US">Country Region</link:label>
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      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_CityAreaCode" xlink:to="dei_CityAreaCode_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_CityAreaCode_lbl" xml:lang="en-US">City Area Code</link:label>
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      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_LocalPhoneNumber" xlink:to="dei_LocalPhoneNumber_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_LocalPhoneNumber_lbl" xml:lang="en-US">Local Phone Number</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_Extension" xlink:label="dei_Extension" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_Extension" xlink:to="dei_Extension_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_Extension_lbl" xml:lang="en-US">Extension</link:label>
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      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_WrittenCommunications" xlink:to="dei_WrittenCommunications_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_WrittenCommunications_lbl" xml:lang="en-US">Written Communications</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_SolicitingMaterial" xlink:label="dei_SolicitingMaterial" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_SolicitingMaterial" xlink:to="dei_SolicitingMaterial_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_SolicitingMaterial_lbl" xml:lang="en-US">Soliciting Material</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_PreCommencementTenderOffer" xlink:label="dei_PreCommencementTenderOffer" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_PreCommencementTenderOffer" xlink:to="dei_PreCommencementTenderOffer_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_PreCommencementTenderOffer_lbl" xml:lang="en-US">Pre-commencement Tender Offer</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_PreCommencementIssuerTenderOffer" xlink:label="dei_PreCommencementIssuerTenderOffer" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_PreCommencementIssuerTenderOffer" xlink:to="dei_PreCommencementIssuerTenderOffer_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_PreCommencementIssuerTenderOffer_lbl" xml:lang="en-US">Pre-commencement Issuer Tender Offer</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_Security12bTitle" xlink:label="dei_Security12bTitle" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_Security12bTitle" xlink:to="dei_Security12bTitle_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_Security12bTitle_lbl" xml:lang="en-US">Title of 12(b) Security</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_NoTradingSymbolFlag" xlink:label="dei_NoTradingSymbolFlag" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_NoTradingSymbolFlag" xlink:to="dei_NoTradingSymbolFlag_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_NoTradingSymbolFlag_lbl" xml:lang="en-US">No Trading Symbol Flag</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_TradingSymbol" xlink:label="dei_TradingSymbol" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_TradingSymbol" xlink:to="dei_TradingSymbol_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_TradingSymbol_lbl" xml:lang="en-US">Trading Symbol</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_SecurityExchangeName" xlink:label="dei_SecurityExchangeName" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_SecurityExchangeName" xlink:to="dei_SecurityExchangeName_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_SecurityExchangeName_lbl" xml:lang="en-US">Security Exchange Name</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_Security12gTitle" xlink:label="dei_Security12gTitle" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_Security12gTitle" xlink:to="dei_Security12gTitle_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_Security12gTitle_lbl" xml:lang="en-US">Title of 12(g) Security</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_SecurityReportingObligation" xlink:label="dei_SecurityReportingObligation" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_SecurityReportingObligation" xlink:to="dei_SecurityReportingObligation_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_SecurityReportingObligation_lbl" xml:lang="en-US">Security Reporting Obligation</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_AnnualInformationForm" xlink:label="dei_AnnualInformationForm" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_AnnualInformationForm" xlink:to="dei_AnnualInformationForm_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_AnnualInformationForm_lbl" xml:lang="en-US">Annual Information Form</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_AuditedAnnualFinancialStatements" xlink:label="dei_AuditedAnnualFinancialStatements" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_AuditedAnnualFinancialStatements" xlink:to="dei_AuditedAnnualFinancialStatements_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_AuditedAnnualFinancialStatements_lbl" xml:lang="en-US">Audited Annual Financial Statements</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_EntityWellKnownSeasonedIssuer" xlink:label="dei_EntityWellKnownSeasonedIssuer" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_EntityWellKnownSeasonedIssuer" xlink:to="dei_EntityWellKnownSeasonedIssuer_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityWellKnownSeasonedIssuer_lbl" xml:lang="en-US">Entity Well-known Seasoned Issuer</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_EntityVoluntaryFilers" xlink:label="dei_EntityVoluntaryFilers" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_EntityVoluntaryFilers" xlink:to="dei_EntityVoluntaryFilers_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityVoluntaryFilers_lbl" xml:lang="en-US">Entity Voluntary Filers</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_EntityCurrentReportingStatus" xlink:label="dei_EntityCurrentReportingStatus" />
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      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityCurrentReportingStatus_lbl" xml:lang="en-US">Entity Current Reporting Status</link:label>
      <link:loc xlink:type="locator" xlink:href="https://xbrl.sec.gov/dei/2025/dei-2025.xsd#dei_EntityInteractiveDataCurrent" xlink:label="dei_EntityInteractiveDataCurrent" />
      <link:labelArc xlink:arcrole="http://www.xbrl.org/2003/arcrole/concept-label" xlink:from="dei_EntityInteractiveDataCurrent" xlink:to="dei_EntityInteractiveDataCurrent_lbl" xlink:type="arc" />
      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityInteractiveDataCurrent_lbl" xml:lang="en-US">Entity Interactive Data Current</link:label>
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      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntityFilerCategory_lbl" xml:lang="en-US">Entity Filer Category</link:label>
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      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_EntitySmallBusiness_lbl" xml:lang="en-US">Entity Small Business</link:label>
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<DESCRIPTION>XBRL PRESENTATION FILE
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<head>
<title></title>
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<span style="display: none;">v3.25.2</span><table class="report" border="0" cellspacing="2" id="id2">
<tr>
<th class="tl" colspan="1" rowspan="1"><div style="width: 200px;"><strong>Cover<br></strong></div></th>
<th class="th"><div>Sep. 09, 2025</div></th>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_CoverAbstract', window );"><strong>Cover [Abstract]</strong></a></td>
<td class="text">&#160;<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_DocumentType', window );">Document Type</a></td>
<td class="text">8-K<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_AmendmentFlag', window );">Amendment Flag</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_DocumentPeriodEndDate', window );">Document Period End Date</a></td>
<td class="text">Sep.  09,  2025<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityFileNumber', window );">Entity File Number</a></td>
<td class="text">001-34949<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityRegistrantName', window );">Entity Registrant Name</a></td>
<td class="text">Arbutus Biopharma Corporation<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityCentralIndexKey', window );">Entity Central Index Key</a></td>
<td class="text">0001447028<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityTaxIdentificationNumber', window );">Entity Tax Identification Number</a></td>
<td class="text">98-0597776<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityIncorporationStateCountryCode', window );">Entity Incorporation, State or Country Code</a></td>
<td class="text">A1<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityAddressAddressLine1', window );">Entity Address, Address Line One</a></td>
<td class="text">701 Veterans Circle<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityAddressCityOrTown', window );">Entity Address, City or Town</a></td>
<td class="text">Warminster<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityAddressStateOrProvince', window );">Entity Address, State or Province</a></td>
<td class="text">PA<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityAddressPostalZipCode', window );">Entity Address, Postal Zip Code</a></td>
<td class="text">18974<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_CityAreaCode', window );">City Area Code</a></td>
<td class="text">(267)<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_LocalPhoneNumber', window );">Local Phone Number</a></td>
<td class="text">469-0914<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_WrittenCommunications', window );">Written Communications</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_SolicitingMaterial', window );">Soliciting Material</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_PreCommencementTenderOffer', window );">Pre-commencement Tender Offer</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_PreCommencementIssuerTenderOffer', window );">Pre-commencement Issuer Tender Offer</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_Security12bTitle', window );">Title of 12(b) Security</a></td>
<td class="text">Common Shares, without par value<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_TradingSymbol', window );">Trading Symbol</a></td>
<td class="text">ABUS<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_SecurityExchangeName', window );">Security Exchange Name</a></td>
<td class="text">NASDAQ<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityEmergingGrowthCompany', window );">Entity Emerging Growth Company</a></td>
<td class="text">false<span></span>
</td>
</tr>
</table>
<div style="display: none;">
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_AmendmentFlag">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_AmendmentFlag</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:booleanItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_CityAreaCode">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Area code of city</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_CityAreaCode</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:normalizedStringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_CoverAbstract">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Cover page.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_CoverAbstract</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:stringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_DocumentPeriodEndDate">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_DocumentPeriodEndDate</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:dateItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_DocumentType">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_DocumentType</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>dei:submissionTypeItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityAddressAddressLine1">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Address Line 1 such as Attn, Building Name, Street Name</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityAddressAddressLine1</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:normalizedStringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityAddressCityOrTown">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Name of the City or Town</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityAddressCityOrTown</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:normalizedStringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityAddressPostalZipCode">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Code for the postal or zip code</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityAddressPostalZipCode</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:normalizedStringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityAddressStateOrProvince">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Name of the state or province.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityAddressStateOrProvince</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>dei:stateOrProvinceItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityCentralIndexKey">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection b-2<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityCentralIndexKey</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>dei:centralIndexKeyItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityEmergingGrowthCompany">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Indicate if registrant meets the emerging growth company criteria.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection b-2<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityEmergingGrowthCompany</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:booleanItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityFileNumber">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityFileNumber</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>dei:fileNumberItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityIncorporationStateCountryCode">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Two-character EDGAR code representing the state or country of incorporation.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityIncorporationStateCountryCode</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>dei:edgarStateCountryItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityRegistrantName">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection b-2<br></p></div>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection b-2<br></p></div>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Local phone number for entity.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 13e<br> -Subsection 4c<br></p></div>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 14d<br> -Subsection 2b<br></p></div>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Title of a 12(b) registered security.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection b<br></p></div>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Name of the Exchange on which a security is registered.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection d1-1<br></p></div>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 14a<br> -Subsection 12<br></p></div>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Trading symbol of an instrument as listed on an exchange.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Securities Act<br> -Number 230<br> -Section 425<br></p></div>
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