Contract analysis

I. INTRODUCTORY STATEMENT Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx" or "Plaintiff"), by and through its undersigned attorneys Calderwood & Harkness LLP, hereby responds and objects to Defendant Helios Precision Diagnostics, Inc.'s ("Helios" or "Defendant") First Set of Interrogatories (Nos. 1–17), which were served on Plaintiff on February 10, 2026, pursuant to Federal Rules of Civil Procedure 26 and 33 and t

II. GENERAL OBJECTIONS GenomeDx makes the following General Objections, which are incorporated by reference into each specific response below as if fully set forth therein. The assertion of a specific objection to any individual interrogatory does not waive GenomeDx's reliance on these General Objections. A. Objection Regarding Scope and Proportionality GenomeDx objects to each and every interrogatory, and to the Def

III. SPECIFIC RESPONSES AND OBJECTIONS INTERROGATORY NO. 1 Identify each claim of each patent-in-suit that GenomeDx contends is infringed by the ProstaSignal™ Genomic Classifier, and for each such claim, state the factual and legal basis for GenomeDx's contention of infringement, including whether infringement is alleged literally, under the doctrine of equivalents, or both. Objection: GenomeDx objects to this interr

1. Dr. Rajan Mehta, Chief Technology Officer, GenomeDx Therapeutics Inc. — Dr. Mehta is a named inventor on all three patents-in-suit (the '271, '893, and '647 Patents). He led the development of GenomeDx's Decipher® genomic classifier methodology, including the identification and validation of the multi-gene expression panel, the development and training of the machine-learning classifier algorithms, and the integra

2. Dr. Carolyn Xu, formerly Principal Scientist at GenomeDx Therapeutics Inc. (departed in 2023; currently employed by Cascadia Genomics, Inc., Seattle, Washington) — Dr. Xu is a named inventor on the '271 Patent and the '893 Patent. She co-developed the multi-gene expression classifier, including the reference-gene normalization methodology claimed in the '893 Patent, and contributed to the selection and validation

3. Dr. David Petrossian — Dr. Petrossian is a named inventor on the '271 Patent. He contributed to early-stage gene panel identification and computational modeling during his tenure as a postdoctoral researcher affiliated with GenomeDx's research collaborators. Dr. Petrossian's current affiliation and contact information are unknown to GenomeDx. GenomeDx has made reasonable efforts to locate Dr. Petrossian and will s

4. Dr. Kevin Ostrowski, Vice President, intellectual Property, GenomeDx Therapeutics Inc. — Dr. Ostrowski is a named inventor on the '647 Patent and oversaw the patent prosecution of the entire patent family, including the '271, '893, and '647 Patents. He coordinated with outside patent prosecution counsel regarding claim drafting and prosecution strategy. Dr. Ostrowski can be contacted through undersigned counsel.

5. Dr. Priya Shah, Senior Scientist, GenomeDx Therapeutics Inc. — Dr. Shah is a named inventor on the '647 Patent. She contributed to the development and validation of the combined genomic-clinical variable model that is the subject of the '647 Patent claims, including the statistical analysis demonstrating the unexpected improvement in predictive accuracy of the combined model relative to genomic-only models. Dr. Sh

6. Dr. Miriam Langford, Chief Executive Officer, GenomeDx Therapeutics Inc. — Dr. Langford has general knowledge of GenomeDx's research and development programs and patent portfolio, including the strategic significance of the patents-in-suit to GenomeDx's business. Dr. Langford was not directly involved in the technical development or patent prosecution of the patents-in-suit but has knowledge of the company's decis

1. GenomeDx's audited financial statements for fiscal year 2024, prepared by its independent auditors, Whitfield & Garner LLP (produced as Bates Nos. GDX-00001001 through GDX-00001089).

2. GenomeDx's internal test volume reports, reimbursement data, and revenue analytics for the period from January 2023 through the present, including monthly test volume by payor type and by ordering institution (produced as Bates Nos. GDX-00005100 through GDX-00005847).

3. Market share analyses prepared by GenomeDx's commercial and strategy teams, including analyses of the competitive landscape for genomic prostate cancer prognostic testing (produced as Bates Nos. GDX-00011200 through GDX-00011356).

4. The Non-Exclusive License Agreement between GenomeDx and Veridian Molecular Labs, Inc., dated April 3, 2022 (produced as Bates Nos. GDX-00024781 through GDX-00024812).

5. Helios's financial records and ProstaSignal™ revenue data produced by Helios in this litigation (Bates prefix HPD), including quarterly revenue reports, test volume data, and reimbursement schedules.

6. Publicly available Medicare reimbursement data for Multianalyte Assays with Algorithmic Analyses (MAAA) codes, specifically code 0047M (assigned to GenomeDx's Decipher® test) and code 0239M (assigned to Helios's ProstaSignal™ test), as published by the Centers for Medicare & Medicaid Services.

7. Documents produced by Helios in this litigation relating to ProstaSignal™ pricing, test volume, commercial strategy, market research, and competitive analyses (Bates prefix HPD).

8. GenomeDx's incremental cost analyses and margin calculations (produced as Bates Nos. GDX-00006200 through GDX-00006389).

9. Industry reports and publications regarding the market for genomic prostate cancer diagnostics. GenomeDx will supplement this response following the completion of Dr. Tremaine's expert analysis and will provide a complete list of materials relied upon by Dr. Tremaine in connection with her expert report, as required by Federal Rule of Civil Procedure 26(a)(2)(B). INTERROGATORY NO. 9 Identify all witnesses GenomeDx

1. Dr. Rajan Mehta, Chief Technology Officer, GenomeDx Therapeutics Inc. — Dr. Mehta has knowledge of the conception, development, and reduction to practice of the inventions claimed in all three patents-in-suit; the technical details of GenomeDx's Decipher® genomic classifier; the technical comparison between Decipher® and Helios's ProstaSignal™; the gene panel selection and validation process; the machine-learning

2. Dr. Kevin Ostrowski, Vice President, intellectual Property, GenomeDx Therapeutics Inc. — Dr. Ostrowski has knowledge of the patent prosecution of the patents-in-suit; GenomeDx's intellectual property strategy; the pre-suit cease-and-desist correspondence with Helios; the freedom-to-operate landscape; and the identification of potentially infringing products in the market.

3. Victoria Sung, General Counsel, GenomeDx Therapeutics Inc. — Ms. Sung has knowledge of GenomeDx's licensing practices and strategy, including the Veridian Molecular Labs license; GenomeDx's IP enforcement decisions; and the circumstances leading to the commencement of this litigation. Ms. Sung has also been designated as GenomeDx's Rule 30(b)(6) witness for topics relating to licensing and IP strategy.

4. Thomas Brennan, Chief Financial Officer, GenomeDx Therapeutics Inc. — Mr. Brennan has knowledge of GenomeDx's financial data, revenue, costs, margins, and the economic impact of Helios's ProstaSignal™ on GenomeDx's business, including test volume trends, market share data, and damages-related financial information. Mr. Brennan has also been designated as GenomeDx's Rule 30(b)(6) witness for topics relating to fina

5. Dr. Miriam Langford, Chief Executive Officer, GenomeDx Therapeutics Inc. — Dr. Langford has knowledge of GenomeDx's corporate strategy, the competitive impact of ProstaSignal™ on GenomeDx's business, GenomeDx's investment in research and development, and the importance of the patents-in-suit to GenomeDx's market position and business model.

6. Dr. Carolyn Xu (currently employed by Cascadia Genomics, Inc., Seattle, Washington) — Dr. Xu has knowledge of the conception and development of the inventions claimed in the '271 and '893 Patents, including the multi-gene expression classifier and the reference-gene normalization methodology.

7. Dr. Priya Shah, Senior Scientist, GenomeDx Therapeutics Inc. — Dr. Shah has knowledge of the conception and development of the combined genomic-clinical variable model that is the subject of the '647 Patent, including the statistical analyses demonstrating the improved predictive performance of the combined model.

8. Dr. David Petrossian (current affiliation unknown) — Dr. Petrossian has knowledge of early-stage gene panel identification work relating to the '271 Patent. Helios Personnel (anticipated adverse witnesses):

9. Dr. Nathan Ashford, Chief Executive Officer, Helios Precision Diagnostics, Inc. — Dr. Ashford is believed to have conceived or directed the conception of the ProstaSignal™ product and has knowledge of Helios's business strategy, competitive positioning, and awareness of GenomeDx's patent portfolio.

10. Dr. Elaine Kossack, Chief Scientific Officer, Helios Precision Diagnostics, Inc. — Dr. Kossack is believed to have led the scientific and technical development of ProstaSignal™, including the gene panel selection, algorithm development, and clinical validation.

11. Dr. Anton Rykov, Senior Scientist, Helios Precision Diagnostics, Inc. — Dr. Rykov is believed to have developed the gradient-boosted decision tree algorithm used in ProstaSignal™.

12. Derek Mallinson, Vice President, Commercial, Helios Precision Diagnostics, Inc. — Mr. Mallinson is believed to have knowledge of the commercial launch of ProstaSignal™, market positioning, competitive intelligence regarding GenomeDx's Decipher® test, and Helios's pricing and reimbursement strategy.

13. Sara Whitmore, General Counsel, Helios Precision Diagnostics, Inc. — Ms. Whitmore is believed to have knowledge of any freedom-to-operate analyses conducted by Helios prior to the launch of ProstaSignal™, and any communications with GenomeDx relating to the patents-in-suit, subject to any assertions of privilege by Helios. Expert Witnesses:

14. Dr. Franklin Ogawa, Professor of Computational Oncology, Stanford University — GenomeDx's proposed technical expert. Dr. Ogawa is expected to provide expert testimony regarding claim construction, infringement analysis (including the relationship between gradient-boosted decision trees and random-forest classifiers), validity, and technical comparisons between the Decipher® test and ProstaSignal™.

15. Dr. Louise Tremaine, Managing Director, Ashworth Economics Group LLC — GenomeDx's proposed damages expert. Dr. Tremaine is expected to provide expert testimony regarding GenomeDx's lost-profits and reasonable-royalty damages theories, including market share analysis, the two-supplier market, incremental margin calculations, and the hypothetical negotiation analysis under the Georgia-Pacific framework. GenomeDx re

1. Knowledge of GenomeDx's Patent Portfolio. Helios launched ProstaSignal™ on or about October 7, 2024, in the same clinical market as GenomeDx's established Decipher® test, with knowledge of GenomeDx's patent portfolio. GenomeDx's patent portfolio includes forty-seven (47) issued U.S. patents relating to genomic prostate cancer diagnostics, many of which are publicly available and have been the subject of published

2. Pre-Launch Documents Referencing GenomeDx Patents. GenomeDx has sought production of Helios's pre-launch business plans, board presentations, strategic planning documents, and investor materials that reference GenomeDx's patents and/or the Decipher® test (Requests for Production Nos. 22, 23, and 31). Helios has produced some responsive documents but has withheld a substantial number of documents on the basis of at

3. Pre-Suit Cease-and-Desist Letter. GenomeDx, through Dr. Kevin Ostrowski, sent a cease-and-desist letter to Sara Whitmore, General Counsel of Helios, in early 2025, prior to the filing of the Complaint, identifying the patents-in-suit and demanding that Helios cease its commercial use of ProstaSignal™ to the extent it infringes the identified patents. Helios did not cease its infringing activities.

4. Deliberately Copied Technology. GenomeDx contends that the high degree of overlap between ProstaSignal™ and GenomeDx's Decipher® test — including 19 of 24 genes in common, the use of similar machine-learning classifier approaches, similar reference-gene normalization methodology, and similar integration of clinical covariates — supports an inference that Helios deliberately copied GenomeDx's patented technology.

5. Egregious Conduct. GenomeDx contends that Helios's awareness of the patents-in-suit, combined with its deliberate decision to launch a directly competing product employing substantially similar technology without obtaining a license or designing around GenomeDx's patents, constitutes egregious conduct warranting enhanced damages under 35 U.S.C. § 284 and the factors set forth in Halo Electronics, Inc. v. Pulse Ele

1. Nakamura et al., U.S. Patent No. 9,617,340 — This reference was cited by the Examiner during prosecution of the '893 Patent and was the basis for a § 102 rejection. The rejection was overcome by distinguishing the random-forest classifier training methodology and minimum cohort size requirement recited in the claims of the '893 Patent. The Examiner withdrew the rejection and allowed the claims.

2. Gagnon, WO 2018/065413 — This reference was cited by the Examiner during prosecution of the '647 Patent and was the basis, in combination with Nakamura, for a § 103 rejection. The rejection was overcome through a declaration under 37 C.F.R. § 1.132 submitted by Dr. Rajan Mehta, which established unexpected results of the combined genomic-clinical variable model as compared to genomic-only models. The Examiner with

3. Thornberry et al., "Machine Learning Approaches to Genomic Risk Stratification in Prostate Cancer," *Journal of Computational Oncology*, Vol. 14, No. 3, pp. 287–301 (March 2015).

4. Klein et al., "A 17-Gene Assay to Predict Prostate Cancer Aggressiveness," *European Urology*, Vol. 66, No. 1, pp. 45–52 (2014). GenomeDx contends that none of the foregoing references, whether taken individually or in any combination, anticipates or renders obvious any asserted claim of the patents-in-suit. GenomeDx's technical expert, Dr. Franklin Ogawa, will address the prior art references identified in Helios