Contract analysis

I. INTRODUCTION Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx") respectfully opposes Defendant Helios Precision Diagnostics, Inc.'s ("Helios") Motion to Dismiss Counts II and III of the Complaint (Dkt. No. 38), filed September 15, 2025. Helios's motion asks this Court to dismiss, at the threshold pleading stage and before any claim construction has occurred, two counts of patent infringement directed to groundbrea

II. STATEMENT OF FACTS A. GenomeDx and Its Patent Portfolio GenomeDx is a Delaware corporation headquartered at 4750 Torrey Pines Road, Suite 300, San Diego, California 92130. Compl. ¶ 3. GenomeDx specializes in molecular diagnostics for cancer prognosis, with a particular focus on developing and commercializing genomic classifier tests that enable physicians to make more informed treatment decisions for patients wit

III. LEGAL STANDARD A. Rule 12(b)(6) Standard Under Federal Rule of Civil Procedure 12(b)(6), a complaint must be dismissed only if it fails to state a claim upon which relief can be granted. Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). To survive a motion to dismiss, a complaint must contain "sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.'" Ashcroft v

IV. ARGUMENT A. The Asserted Claims of the '893 Patent Are Directed to a Patent-Eligible Diagnostic Method, Not an Abstract Idea

1. Step One: The '893 Patent Claims Are Not "Directed To" a Law of Nature or Abstract Idea. Helios's motion characterizes the claims of the '893 Patent as merely "applying a mathematical algorithm to gene expression data" and contends that gene expression levels are "natural phenomena" that cannot be the subject of a patent. Mot. at 8–12. This characterization improperly dissects the claims, strips away their specifi

2. Step Two: Even Under Helios's Characterization, the Claims Contain an Inventive Concept. Even assuming arguendo that this Court were to conclude at Step One that the '893 Patent claims are "directed to" a natural phenomenon or abstract idea — a conclusion GenomeDx vigorously disputes — the claims nonetheless recite sufficient inventive concepts to satisfy Step Two of the Alice/Mayo framework. The Supreme Court has

1. Step One: The '647 Patent Claims Are Not "Directed To" a Law of Nature or Abstract Idea. The '647 Patent claims a fundamentally different and more integrated method than the generic "gene-expression analysis" that Helios invokes. While the '893 Patent claims are directed to a specific method of generating a genomic prognostic score, the '647 Patent claims go further by requiring the integration of a genomic risk s

2. Step Two: The Combined Genomic-Clinical Model Represents an Inventive Concept. Even assuming arguendo that the '647 Patent claims are "directed to" a natural phenomenon or abstract idea at Step One — which GenomeDx disputes — the claims recite an inventive concept sufficient to satisfy Step Two. The prosecution history of the '647 Patent is particularly instructive on this point. As described above, the Examiner r

1. Disputed Claim Terms Bear Directly on the Eligibility Analysis. Entirely apart from the substantive merits of the eligibility analysis, Helios's motion should be denied as premature. The parties exchanged proposed claim construction terms on August 4, 2025 and identified multiple disputed terms relevant to the '893 and '647 Patents, including: • "random-forest classifier trained on a cohort of at least 500 patient

2. Courts Routinely Defer § 101 to Post-Claim-Construction. Courts in this District and the Federal Circuit have recognized that resolving patent eligibility before construing disputed claim terms risks error and is generally disfavored when the claim scope is genuinely in dispute. The Federal Circuit has held that "claim construction may be helpful, and in some cases necessary, to resolve § 101 issues." MyMail