Contract analysis

I. Executive Summary This memorandum assesses whether amendments and arguments made during the prosecution of the three patents-in-suit — U.S. Patent Nos. 10,438,271 (the "'271 Patent"), 11,204,893 (the "'893 Patent"), and 11,891,647 (the "'647 Patent") — create prosecution history estoppel ("PHE") that would limit our client Genome Dx Therapeutics Inc.'s ("GenomeDx") ability to assert infringement under the doctrine

II. Legal Framework — Prosecution History Estoppel Before turning to the patent-specific prosecution histories, it is useful to set forth the legal framework governing prosecution history estoppel and its interaction with the doctrine of equivalents. This framework will inform the analysis in Sections III through V below. A. Doctrine of Equivalents — General Principles The doctrine of equivalents is a judicially crea

III. Prosecution History of the '271 Patent (U.S. Patent No. 10,438,271) A. Overview. The '271 Patent is titled "Methods for Predicting Prostate Cancer Outcomes Using Multi-Gene Expression Classifiers." It was filed on June 14, 2016 and issued on October 8, 2019, with an expiration date of June 14, 2036. The named inventors are Dr. Rajan Mehta, Dr. Carolyn Xu, and Dr. David Petrossian, all of whom were employed by Ge

IV. Prosecution History of the '893 Patent (U.S. Patent No. 11,204,893) A. Overview. The '893 Patent is titled "Genomic Classifier Systems and Methods for Post-Surgical Cancer Prognosis." It was filed on March 22, 2019 as a continuation of the '271 Patent, sharing the same priority chain and the same ultimate expiration date of June 14, 2036. The named inventors are Dr. Rajan Mehta and Dr. Carolyn Xu. The '893 Patent

V. Prosecution History of the '647 Patent (U.S. Patent No. 11,891,647) A. Overview. The '647 Patent is titled "Improved Methods for Genomic Risk Stratification in Prostate Cancer Using Combined Biomarker and Clinical Variable Models." It was filed on September 9, 2021 and issued on February 6, 2024, with an expiration date of September 9, 2041 (subject to the terminal disclaimer discussed below). The named inventors

VI. Cross-Patent Analysis and Strategic Implications A. Summary Table of PHE Risk by Patent The following table summarizes the PHE risk assessment for each patent-in-suit: B. Interplay Between the '271 and '893 Patents The relationship between the '271 and '893 Patents is a critical strategic consideration that warrants careful analysis. The two patents share the same priority chain (the '893 Patent is a continuation