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Commitments and Contingencies | 12 Months Ended
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Dec. 31, 2023
Commitments and Contingencies Disclosure [Abstract] |
Commitments and Contingencies | Note 11. Commitments and Contingencies Contingencies On August 2, 2022, the Company filed a complaint in the U.S. District Court for the District of Colorado (the "District Court") against Foresight Diagnostics Inc. (“Foresight”) for patent infringement. The complaint is based on the Company’s U.S. Patent No. 10,450,611 (the “’611 Patent”), entitled “Personalized Genetic Testing,” our U.S. Patent No. 11,299,783 (the “’783 Patent”), entitled “Methods and Systems For Genetic Analysis,” and our U.S. Patent No. 11,384,394 (the “’394 Patent”), entitled “Methods and Systems for Genetic Analysis.” The ‘611 Patent was granted on October 22, 2019, and relates to methods for personalized genetic testing by performance of sequencing assays on biological samples. The ‘783 Patent was granted on April 12, 2022, and relates to methods for sample processing and data analysis by performance of sequencing assays on biological samples that can aid in the diagnosis, monitoring, treatment, and prevention of one or more diseases. The ‘394 Patent was granted on July 12, 2022, and relates to methods for sample processing and analysis to aid in the diagnosis, monitoring, treatment, and prevention of disease. On August 17, 2022, the Company filed an amended complaint for patent infringement against Foresight. The amended complaint added our U.S. Patent No. 11,408,033 (the “’033 Patent”), entitled “Methods and Systems for Genetic Analysis.” The ‘033 Patent was granted on August 9, 2022, and relates to methods for sample processing and analysis to aid in the diagnosis, monitoring, treatment, and prevention of disease. The Company is seeking remedies including injunctive relief, damages and costs. On October 12, 2022, Foresight filed its answer and counterclaims in the matter, seeking declaratory judgment and alleging that its solid tumor recurrence test does not infringe the Company’s asserted patents and that the claims of our asserted patents are invalid and/or unenforceable. On November 2, 2022, the Company filed its answer to Foresight’s counterclaims. The Company intends to vigorously defend against these counterclaims. Between November 30, 2022 and February 10, 2023, inclusive, Foresight filed four inter partes review petitions with the USPTO, seeking to invalidate the four patents that we are asserting against Foresight in our first patent infringement action. Also on November 30, 2022, Foresight filed a motion to stay our first patent infringement action in the District Court pending the resolution of the inter partes review proceedings that Foresight has requested. On January 24, 2023, the District Court granted Foresight’s motion to stay. On June 13, 2023, the USPTO issued decisions granting inter partes reviews of the '394 and '033 Patents. On August 8, 2023, the USPTO issued decisions granting inter partes reviews of the '611 and '783 Patents. On June 26, 2023, the Company filed a second complaint in the District Court against Foresight for patent infringement. The complaint is based on the Company’s U.S. Patent No. 11,584,968 (the “’968 Patent”), entitled “Methods For Using Mosaicism in Nucleic Acids Sampled Distal to Their Origin,” our U.S. Patent No. 11,649,507 (the “’507 Patent”), entitled “Methods for Using Mosaicism in Nucleic Acids Sampled Distal to Their Origin,” and our U.S. Patent No. 11,643,685 (the “’685 Patent”), entitled “Methods and Systems For Genetic Analysis.” The ’968 Patent was granted on February 21, 2023, and relates to methods for improving detection and monitoring of human diseases. The ’507 Patent was granted on May 16, 2023, and relates to methods for detection and monitoring of human disease by providing spatial or developmental localization of mutations within the body which is used in monitoring states of health in tissues of the body. The ’685 Patent was granted on May 9, 2023, and relates to methods for sample processing and analysis to aid in the diagnosis, monitoring, treatment, and prevention of disease. The Company is seeking remedies including injunctive relief, damages and costs. On August 10, 2023, Foresight filed a motion to dismiss the Company’s second complaint. On August 31, 2023, the Company filed a response to Foresight’s motion and also filed an amended complaint. On September 6, 2023, the District Court denied Foresight’s motion as moot in light of the Company’s amended complaint. On September 14, 2023, Foresight filed its answer and counterclaims in the matter, seeking declaratory judgment and alleging that its solid tumor recurrence test does not infringe the Company’s asserted patents in the Company’s second patent infringement action and that the Company’s asserted patents in that action are invalid and/or unenforceable. On October 5, 2023, the Company filed its answer to Foresight’s counterclaims. The Company intends to vigorously defend against these counterclaims. On October 20, 2023, Foresight filed a motion to consolidate the Company’s two patent infringement actions in the District Court, and if consolidated, to maintain the stay as to all of the Company’s asserted patents pending the resolution of the first four inter partes review proceedings and the three additional inter partes review petitions that Foresight has alleged it will file as soon as it is permitted by statute to do so, seeking to invalidate the three patents that the Company is asserting against Foresight in the Company’s second patent infringement action. The Company filed its opposition to Foresight’s motion to consolidate and stay the infringement actions on November 8, 2023. On November 22, 2023, Foresight filed its fifth inter partes review petition with the USPTO, seeking to invalidate the ’968 Patent that we are asserting against Foresight in our second patent infringement action. On January 23, 2024, the District Court granted Foresight’s motion to consolidate and stay our two infringement actions against Foresight. The USPTO has yet to issue a decision regarding whether it will institute an inter partes review of our ’968 Patent. Litigation is inherently unpredictable, and, except for events that have already occurred, it is too early in the foregoing proceedings to predict the outcome of these proceedings, or any impact they may have on us. As such, the estimated financial effect associated with this complaint cannot be made as of the date of filing of this Annual Report on Form 10-K. Litigation is a significant ongoing expense with an uncertain outcome and may in the future be a material expense for us. Management believes this investment is important to protect our intellectual property position, even recognizing the uncertainty of the outcome. The Company is also subject to claims and assessments from time to time in the ordinary course of business. Accruals for litigation and loss contingencies are reflected in the consolidated financial statements based on management’s assessment, including the advice of legal counsel, of the expected outcome of litigation or other dispute resolution proceedings and/or the expected resolution of contingencies. Liabilities for estimated losses are accrued if the potential losses from any claims or legal proceedings are considered probable and the amounts can be reasonably estimated. Significant judgment is required in both the determination of probability of loss and the determination as to whether the amount can be reasonably estimated. Accruals are based only on information available at the time of the assessment due to the uncertain nature of such matters. As additional information becomes available, management reassesses potential liabilities related to pending claims and litigation and may revise its previous estimates, which could materially affect the Company’s consolidated results of operations in a given period. Except for the matter described in the first four paragraphs of this Note 11, as of December 31, 2023, the Company was not involved in any material legal proceedings. Indemnification In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future, but that have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations.

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