1013-00005 · Genome Dx Therapeutics Inc · Discovery/Responses

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UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA

DRAFT — FOR INTERNAL REVIEW ONLY — NOT YET SERVED ON OPPOSING COUNSEL Draft Date: February 2026 Prepared by: Peter Vassiliev and Wendy Schultz, Calderwood & Harkness LLP 555 Mission Street, Suite 3100, San Francisco, CA 94105 For review by: Catherine Bloom (Responsible Partner) and Victoria Sung (GenomeDx General Counsel) NOTE: Responses subject to verification by GenomeDx corporate representative prior to service.

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 the Local Rules of the United States District Court for the Northern District of California.

These responses are made based upon information reasonably available to GenomeDx as of the date of service of these responses and are made without prejudice to GenomeDx's right to supplement, amend, or correct its responses as additional information becomes available through the ongoing course of discovery in this action, including but not limited to information obtained through document production, depositions, third-party discovery, and expert analysis.

Discovery in this matter is ongoing. Fact discovery is currently scheduled to close on March 6, 2026, pursuant to the Scheduling Order entered on June 18, 2025 by the Honorable Jessica W. Langston. Expert reports are due on May 15, 2026, and rebuttal expert reports are due on July 10, 2026. GenomeDx expressly reserves the right to supplement and amend its responses and objections in accordance with the continuing obligation to supplement imposed by Federal Rule of Civil Procedure 26(e) and any orders of this Court.

The responses set forth herein are based on GenomeDx's current understanding of the facts and applicable law. No response herein shall be deemed an admission of the relevance, materiality, or admissibility of any interrogatory or of the subject matter to which any interrogatory relates. GenomeDx's investigation is continuing, and it should not be assumed that GenomeDx has completed its factual or legal analysis with respect to any of the matters addressed herein.

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 Definitions and Instructions accompanying Defendant's First Set of Interrogatories, to the extent any such interrogatory is overly broad, unduly burdensome, or not proportional to the needs of this case as required by Federal Rule of Civil Procedure 26(b)(1). In assessing proportionality, GenomeDx has considered the importance of the issues at stake in this action, the amount in controversy, the parties' relative access to relevant information, the parties' resources, the importance of the discovery in resolving the issues, and whether the burden or expense of the proposed discovery outweighs its likely benefit. GenomeDx has endeavored to respond to the extent each interrogatory is reasonably construed and proportional to the needs of the case, but objects to any construction that would impose obligations exceeding those boundaries.

B. Objection Regarding Attorney-Client Privilege and Work Product

GenomeDx objects to each and every interrogatory to the extent it calls for or seeks information, communications, or documents protected by the attorney-client privilege, the attorney work-product doctrine, the joint defense or common interest privilege, or any other applicable privilege or immunity from disclosure. GenomeDx does not intend by these responses to waive, and does not waive, any such privilege or protection. No inadvertent production or disclosure of any privileged or protected information shall operate as a waiver of any privilege or protection, whether in this proceeding or in any other proceeding, consistent with (i) the Stipulated Protective Order entered by the Court on December 18, 2025, (ii) any order entered pursuant to Federal Rule of Evidence 502(d), and (iii) Federal Rule of Civil Procedure 26(b)(5)(B).

C. Objection Regarding Premature Contention Interrogatories

GenomeDx objects to each interrogatory that constitutes or includes a contention interrogatory, to the extent it seeks expert opinions, legal conclusions, or legal theories that have not yet been fully developed. Discovery in this action is ongoing. Expert reports are not due until May 15, 2026, pursuant to the Scheduling Order entered June 18, 2025. Claim construction proceedings are pending. To the extent GenomeDx responds to contention interrogatories, it does so based on its current understanding and contentions, which are expressly subject to supplementation, amendment, and refinement as discovery continues, as expert analyses are completed, and as claim construction issues are resolved by the Court. GenomeDx's responses to contention interrogatories should not be construed as a complete or final statement of its positions.

D. Objection Regarding Claim Construction

GenomeDx objects to each and every interrogatory to the extent it requires, assumes, or presupposes a particular construction of any claim term of the patents-in-suit, U.S. Patent Nos. 10,438,271, 11,204,893, and 11,891,647. The parties exchanged proposed claim construction terms and their proposed constructions on August 4, 2025, and the Markman hearing before the Honorable Jessica W. Langston is not scheduled until September 18, 2026. GenomeDx's responses herein are based upon GenomeDx's proposed claim constructions and do not constitute admissions as to the scope or meaning of any claim term. GenomeDx reserves the right to modify, supplement, or amend its responses following the Court's claim construction ruling.

E. Objection Regarding Definitions and Instructions

GenomeDx objects to Defendant's Definitions and Instructions accompanying its First Set of Interrogatories to the extent they purport to impose obligations beyond those required by the Federal Rules of Civil Procedure, the Local Rules of the United States District Court for the Northern District of California, or the Patent Local Rules. GenomeDx will construe Defendant's interrogatories in accordance with the Federal Rules, Local Rules, and Patent Local Rules, and responds on that basis.

F. Reservation of Rights

By responding to Defendant's First Set of Interrogatories, GenomeDx does not waive, and expressly reserves, any objection to the admissibility, relevance, or materiality of the interrogatories or the subject matter to which they relate. GenomeDx further reserves the right to assert additional objections, defenses, claims, and contentions as discovery progresses, as claim construction proceedings are conducted, and as expert analysis is completed. Subject to and without waiving these General Objections, GenomeDx responds to each interrogatory as set forth below.

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 interrogatory to the extent it is overly broad and seeks all factual and legal bases for each infringement contention at this preliminary stage of the litigation. This interrogatory constitutes a contention interrogatory, and GenomeDx's response is subject to supplementation following the Markman hearing on claim construction, currently scheduled for September 18, 2026, and following service of expert reports on May 15, 2026. GenomeDx further objects to this interrogatory to the extent it is duplicative of the infringement contentions and claim charts served by GenomeDx pursuant to Patent Local Rule 3-1, which provide detailed element-by-element mapping of each asserted claim to the accused ProstaSignal™ product.

Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:

GenomeDx contends that Helios's ProstaSignal™ Genomic Classifier infringes the following claims of the patents-in-suit:

• U.S. Patent No. 10,438,271 ("the '271 Patent"): Claims 1, 3, 5, 7, 12, and 18.

• U.S. Patent No. 11,204,893 ("the '893 Patent"): Claims 1, 2, 9, 14, and 20.

• U.S. Patent No. 11,891,647 ("the '647 Patent"): Claims 1, 4, 6, 11, and 15.

GenomeDx's infringement theories are set forth in detail in the Complaint filed March 28, 2025 (Dkt. No. 1) and in the claim charts served with GenomeDx's infringement contentions on September 5, 2025, pursuant to Patent Local Rule 3-1, which GenomeDx incorporates by reference herein. GenomeDx's infringement contentions were further amended on November 14, 2025, in accordance with Patent Local Rule 3-6.

In summary, and without limitation, GenomeDx's infringement contentions are based on the following factual grounds: Helios's ProstaSignal™ Genomic Classifier (i) uses a 24-gene expression panel to analyze tumor tissue from prostate cancer patients, 19 of which genes overlap with the gene set identified and claimed in GenomeDx's patents-in-suit; (ii) employs a trained machine-learning classifier, specifically a gradient-boosted decision tree algorithm, to generate a numerical prognostic score (referred to by Helios as a "ProstaScore," ranging from 0 to 100); (iii) classifies patients into Low, Intermediate, or High risk categories based on the ProstaScore; and (iv) combines the ProstaScore with clinical covariates including, at minimum, Gleason grade group and pre-operative prostate-specific antigen (PSA) level to generate an integrated prognostic report that is transmitted to the ordering healthcare provider.

With respect to the '893 Patent, which recites a "random-forest classifier" in certain claims, GenomeDx contends that Helios's gradient-boosted decision tree classifier literally infringes the asserted claims under a proper construction of the term "random-forest classifier," which GenomeDx contends encompasses ensemble machine-learning methods that aggregate the outputs of multiple decision trees. Alternatively, GenomeDx contends that Helios's gradient-boosted decision tree infringes the asserted claims of the '893 Patent under the doctrine of equivalents, as described in further detail in GenomeDx's response to Interrogatory No. 3 below.

GenomeDx reserves the right to supplement this response following the Markman hearing on September 18, 2026, and following service of its technical expert report on May 15, 2026. GenomeDx further reserves the right to assert additional claims of infringement, including additional claims or additional theories of infringement, as discovery continues.

INTERROGATORY NO. 2

For each claim of each patent-in-suit that GenomeDx contends is infringed by ProstaSignal™, identify the specific element, component, feature, step, or limitation of ProstaSignal™ that GenomeDx contends meets each limitation of the asserted claim.

Objection: GenomeDx objects to this interrogatory as duplicative of the element-by-element claim charts served by GenomeDx in compliance with Patent Local Rule 3-1 on September 5, 2025, as amended on November 14, 2025. Those claim charts were specifically designed to and do identify, for each asserted claim, the specific element, component, feature, step, or limitation of ProstaSignal™ that meets each limitation. Requiring GenomeDx to restate that element-by-element mapping in narrative form is unduly burdensome and serves no legitimate discovery purpose not already satisfied by the Patent Local Rule disclosures. GenomeDx further objects to this interrogatory as overly broad and disproportionate to the needs of the case.

Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:

GenomeDx refers to and incorporates by reference its claim charts for the '271 Patent, '893 Patent, and '647 Patent, which provide detailed element-by-element mapping of each asserted claim against the ProstaSignal™ Genomic Classifier. These charts were served in compliance with Patent Local Rules 3-1 and 3-6 and constitute the most detailed and accurate statement of GenomeDx's element-by-element infringement contentions at this time. GenomeDx will supplement this interrogatory response to the extent its claim charts are updated following claim construction proceedings or the completion of expert analysis.

Without limitation, and by way of summary only, the key element-by-element mappings for representative independent claims include the following:

'271 Patent, Claim 1:

(a) A method for generating a prognostic score from a biological sample containing tumor RNA — ProstaSignal™ is a method that generates a prognostic score (ProstaScore) from a biological sample containing tumor RNA. Specifically, ProstaSignal™ uses formalin-fixed paraffin-embedded (FFPE) prostate tumor tissue from which RNA is extracted using proprietary extraction protocols prior to analysis.

(b) Measuring expression levels of a panel of at least 22 genes — ProstaSignal™ measures the expression levels of a 24-gene panel. Nineteen (19) of those genes are from GenomeDx's predefined gene set as identified in the '271 Patent specification. The remaining five genes include three reference genes and two genes identified in published literature co-authored by former GenomeDx collaborators.

(c) Applying a trained machine-learning classifier to the measured expression levels — ProstaSignal™ applies a trained machine-learning classifier, specifically a gradient-boosted decision tree algorithm, to the measured gene expression levels to generate the ProstaScore.

(d) Classifying the patient into one of at least three risk categories based on the output of the machine-learning classifier — ProstaSignal™ classifies patients into three risk categories — Low, Intermediate, and High — based on the ProstaScore.

'893 Patent, Claim 1:

(a) Normalizing expression data using a reference gene panel — ProstaSignal™ performs reference-gene normalization using at least three reference genes (GAPDH, ARF1, and ATP5E, or equivalents thereof) prior to application of the classifier algorithm.

(b) Applying a random-forest classifier trained on a cohort of at least 500 patient samples — Literally met under GenomeDx's proposed construction of "random-forest classifier," which encompasses ensemble methods aggregating outputs of multiple decision trees, including gradient-boosted decision trees; or, alternatively, met under the doctrine of equivalents because Helios's gradient-boosted decision tree performs substantially the same function, in substantially the same way, to achieve substantially the same result as a random-forest classifier. The ProstaSignal™ classifier was trained on a cohort of approximately 1,200 patient samples from six academic medical centers, meeting the "at least 500 patient samples" limitation.

(c) Generating a numerical prognostic score correlated with the probability of metastasis within 5 years of initial diagnosis — The ProstaScore (ranging from 0 to 100) is correlated with the probability of metastasis within five years following radical prostatectomy.

'647 Patent, Claim 1:

(a) A method for generating an integrated prognostic assessment combining biomarker data and clinical variable data — ProstaSignal™ combines the gene-expression-derived ProstaScore with at least two clinical covariates (Gleason grade group and pre-operative PSA level) to generate an integrated prognostic assessment.

(b) Generating an integrated prognostic report transmitted to a healthcare provider — ProstaSignal™ generates a prognostic report that is transmitted electronically to the ordering healthcare provider, typically a urologist or radiation oncologist, via Helios's proprietary reporting portal and/or integration with the provider's electronic health record (EHR) system.

GenomeDx reserves the right to supplement these mappings as claim construction proceedings and expert analysis continue.

INTERROGATORY NO. 3

State the factual and technical basis for GenomeDx's contention that Helios's use of a gradient-boosted decision tree classifier in the ProstaSignal™ product infringes claims of the '893 Patent that recite a "random-forest classifier," including whether infringement is alleged literally, under the doctrine of equivalents, or both.

Objection: GenomeDx objects to this interrogatory as a contention interrogatory that seeks expert opinions and technical analyses that have not yet been fully developed. GenomeDx's full theory regarding the relationship between gradient-boosted decision trees and random-forest classifiers will be articulated through expert testimony in the report of GenomeDx's technical expert, Dr. Franklin Ogawa, which is due May 15, 2026. GenomeDx responds to the extent of its current contentions, subject to supplementation.

Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:

GenomeDx contends that the term "random-forest classifier" as used in the asserted claims of the '893 Patent, properly construed, encompasses ensemble machine-learning methods that aggregate the outputs of multiple decision trees to generate a prediction, which includes gradient-boosted decision tree classifiers of the type used in Helios's ProstaSignal™ product. GenomeDx's proposed construction of "random-forest classifier" is set forth in GenomeDx's claim construction brief, which was served on the parties on August 4, 2025. GenomeDx contends that the '893 Patent specification uses the term "random-forest classifier" to describe the general category of ensemble tree-based methods, and that a person of ordinary skill in the art at the time of the invention would have understood the term to encompass gradient-boosted decision tree methods.

Alternatively, even if the term "random-forest classifier" is construed narrowly to be limited to the classical random-forest algorithm as described in Breiman (2001), GenomeDx contends that Helios's gradient-boosted decision tree classifier infringes the asserted claims of the '893 Patent under the doctrine of equivalents. Specifically:

• Function: Helios's gradient-boosted decision tree performs substantially the same function as a random-forest classifier — namely, aggregating predictions from an ensemble of decision trees trained on patient cohort data to generate a numerical prognostic score.

• Way: Helios's gradient-boosted decision tree operates in substantially the same way as a random-forest classifier — namely, by sequentially building and combining multiple decision-tree models using training data from patient cohorts, wherein each tree in the ensemble contributes to the final prediction. While the classical random-forest algorithm builds trees in parallel using bootstrapped samples and random feature subsets, and the gradient-boosted decision tree algorithm builds trees sequentially with each tree correcting the errors of the prior trees, both methods fundamentally operate by constructing and aggregating ensembles of decision trees from the same type of training data (gene expression measurements from patient cohorts).

• Result: Helios's gradient-boosted decision tree achieves substantially the same result as a random-forest classifier — namely, a numerical prognostic score (the ProstaScore) correlated with the probability of metastasis within five years, which is used to classify patients into risk categories. Published literature, including Helios's own peer-reviewed validation study (Ashford et al., Journal of Clinical Oncology, Vol. 42, No. 28, pp. 3311–3319 (2024)), demonstrates that the predictive performance of ProstaSignal™ is statistically comparable to that of classifiers employing random-forest algorithms in the same clinical context.

GenomeDx further contends that the doctrine of equivalents is not barred by prosecution history estoppel with respect to the '893 Patent. During prosecution, the claims of the '893 Patent were narrowed from reciting a generic "machine-learning classifier" to reciting a "random-forest classifier" to overcome a § 102 rejection based on the Nakamura reference, which disclosed a single-tree logistic model tree classifier. Gradient-boosted decision trees are ensemble tree-based methods that are not within the territory surrendered by the narrowing amendment, because the amendment was directed to distinguishing single-tree classifiers, not other ensemble tree-based methods.

GenomeDx will supplement this response with expert testimony from Dr. Franklin Ogawa, Professor of Computational Oncology at Stanford University, whose expert report is due May 15, 2026.

INTERROGATORY NO. 4

Identify all persons with knowledge of the conception, development, reduction to practice, and/or patenting of each patent-in-suit, including, for each person, a summary of that person's involvement and current contact information, if known.

Objection: GenomeDx objects to this interrogatory as overly broad to the extent it seeks information regarding every person who may have had any involvement, however peripheral, in the conception, development, reduction to practice, or patenting of the patents-in-suit. GenomeDx further objects to the extent this interrogatory seeks privileged attorney-client communications relating to patent prosecution strategy. Subject to these objections, GenomeDx responds with respect to persons with material knowledge.

Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:

The following persons have knowledge of the conception, development, and/or reduction to practice of one or more of the patents-in-suit:

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 integration of clinical covariates into the combined prognostic model. Dr. Mehta has been employed by GenomeDx since 2012 and can be contacted through undersigned counsel.

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 of the gene panel. Dr. Xu's last known contact information is care of Cascadia Genomics, Inc., 1501 Elliott Avenue West, Suite 200, Seattle, WA 98119.

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 supplement this response if his current information is obtained.

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. Shah can be contacted through undersigned counsel.

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 decision to pursue patent protection and its commercialization of the Decipher® test. Dr. Langford can be contacted through undersigned counsel.

GenomeDx reserves the right to supplement this response as additional witnesses are identified through ongoing discovery and investigation.

INTERROGATORY NO. 5

Identify all licenses, sublicenses, assignments, agreements, or other transactions relating to any of the patents-in-suit, including the parties thereto, the date of execution, the scope of the rights granted, and any financial terms.

Objection: GenomeDx objects to this interrogatory to the extent it seeks information protected by the attorney-client privilege, the work-product doctrine, or the terms of confidential third-party agreements beyond what is relevant to the claims and defenses in this litigation. GenomeDx further objects to this interrogatory to the extent it seeks financial or business terms of agreements that are subject to confidentiality provisions with third parties, and to the extent it is overly broad in seeking information regarding "other transactions" without meaningful limitation. GenomeDx responds to the extent the interrogatory seeks information regarding licenses and similar agreements that are relevant to the issues in this case, including damages.

Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:

GenomeDx identifies the following license agreement relating to the patents-in-suit:

Non-Exclusive License Agreement dated April 3, 2022, between GenomeDx Therapeutics Inc. (as licensor) and Veridian Molecular Labs, Inc. (as licensee). This agreement grants Veridian a non-exclusive license under the '271 Patent and the '893 Patent for use in Veridian's bladder cancer diagnostic product (a clinical application distinct from the prostate cancer application at issue in this litigation). The license provides for a running royalty of fifteen percent (15%) of net revenues derived from licensed products, with a minimum annual royalty of Five Hundred Thousand Dollars ($500,000). The term of the license is co-extensive with the patent life of the licensed patents. The licensed field is expressly limited to bladder cancer diagnostics, and the license does not extend to prostate cancer diagnostics or any other clinical application. The agreement was produced to Helios on December 2, 2025, as Bates No. GDX-00024781 through GDX-00024812, subject to the Confidentiality provisions of the Stipulated Protective Order.

Other than the foregoing, GenomeDx is not aware of any other licenses, sublicenses, assignments, or agreements with third parties relating to the patents-in-suit, other than (i) invention assignment agreements between GenomeDx and its employees and co-inventors, executed in the ordinary course of the employment relationship, pursuant to which the named inventors assigned their rights in the inventions to GenomeDx, and (ii) agreements between GenomeDx and its outside patent prosecution counsel, which are protected by the attorney-client privilege.

GenomeDx reserves the right to supplement this response as discovery continues.

INTERROGATORY NO. 6

State all facts supporting GenomeDx's lost-profits damages theory, including but not limited to market share data, pricing information, margin calculations, the basis for any assertion of a two-supplier market, and the total amount of lost-profits damages claimed.

Objection: GenomeDx objects to this interrogatory as a contention interrogatory that is premature to the extent it seeks the full articulation of GenomeDx's damages theory before expert reports are due on May 15, 2026. GenomeDx's damages expert, Dr. Louise Tremaine of Ashworth Economics Group LLC, has not yet completed her analysis, and her expert report will set forth GenomeDx's detailed damages contentions. GenomeDx's response is subject to supplementation following the completion of expert analysis. GenomeDx further objects to this interrogatory as overly broad and unduly burdensome in its demand for "all facts" supporting a complex economic theory.

Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:

GenomeDx contends it is entitled to lost profits as its primary measure of damages under 35 U.S.C. § 284, based on the following facts and contentions, which are preliminary and subject to supplementation:

Market Share. GenomeDx is the market leader in genomic prostate cancer prognostic testing. Prior to the launch of Helios's ProstaSignal™ Genomic Classifier on or about October 7, 2024, GenomeDx held approximately seventy-four percent (74%) of the U.S. market for genomic prostate cancer prognostic classifiers, as measured by test volume. Following the launch of ProstaSignal™, GenomeDx's market share declined to approximately sixty-eight percent (68%) through March 2025. This market share data is based on GenomeDx's internal commercial analyses, Medicare claims data for MAAA codes 0047M (Decipher®) and 0239M (ProstaSignal™), and publicly available industry reports.

Demand for the Patented Product. GenomeDx's Decipher® test and Helios's ProstaSignal™ are directly competing products in the same clinical niche — specifically, post-radical prostatectomy prostate cancer prognosis and treatment decision support. Both tests use multi-gene expression panels and machine-learning classifiers to generate prognostic risk scores from FFPE prostate tumor tissue, and both are ordered by urologists and radiation oncologists for the same patient population. GenomeDx contends that, absent Helios's infringement, a substantial portion of the ProstaSignal™ test volume would have been performed using GenomeDx's Decipher® test.

Two-Supplier Market. GenomeDx contends that the relevant market for genomic prostate cancer prognostic classifiers using multi-gene expression panels and machine-learning classifiers was effectively a two-supplier market following ProstaSignal™'s commercial launch in October 2024, with GenomeDx (Decipher®) and Helios (ProstaSignal™) as the primary competitors for the specific clinical indication of post-prostatectomy genomic risk stratification. While other genomic prostate cancer tests exist (such as the Oncotype DX Genomic Prostate Score® test and the Prolaris® test), GenomeDx contends that those tests serve different clinical niches (e.g., biopsy-based active surveillance decisions rather than post-prostatectomy treatment intensification decisions), have different gene panels, and are not close substitutes for Decipher® or ProstaSignal™ in the post-prostatectomy setting.

Diverted Tests. GenomeDx estimates that approximately 6,100 of Helios's approximately 8,400 ProstaSignal™ tests performed during the period from October 2024 through March 2025 would have been performed by GenomeDx using the Decipher® test absent Helios's infringement. This estimate is based on GenomeDx's pre-infringement market share, the degree of substitutability between the two products, and an analysis of ordering physician patterns. The remaining approximately 2,300 tests represent market expansion attributable to Helios's marketing efforts and physicians who would not have ordered any genomic prognostic test absent ProstaSignal™.

Pricing. GenomeDx's average net reimbursement per Decipher® test in fiscal year 2024 was $4,210, based on a blended average of Medicare reimbursement, commercial payor reimbursement, and institutional pricing. This figure is derived from GenomeDx's audited financial statements and internal revenue data.

Estimated Lost Revenue. Based on the foregoing, GenomeDx's preliminary estimate of lost revenue for the October 2024 through March 2025 period is: 6,100 diverted tests × $4,210 average reimbursement per test = $25,681,000.

Incremental Margin. GenomeDx's incremental profit margin on additional test volume is approximately seventy-two percent (72%). This margin reflects the incremental costs that GenomeDx would have incurred to process the additional 6,100 tests, including reagent costs, laboratory consumables, labor, and shipping, while excluding fixed costs (facilities, equipment depreciation, general and administrative overhead) that are already absorbed by GenomeDx's existing test volume. GenomeDx's incremental margin is higher than its overall EBITDA margin because fixed costs are already covered at GenomeDx's current production levels.

Estimated Lost Profits. GenomeDx's preliminary estimate of lost profits for the October 2024 through March 2025 period is: $25,681,000 × 72% = $18,490,320. This estimate is preliminary and subject to adjustment based on updated test volume data, further analysis of diverted demand, and the expert analysis of Dr. Louise Tremaine.

Revenue and Financial Data. For context, GenomeDx's total revenue for fiscal year 2024 was $387.6 million. GenomeDx's EBITDA for fiscal year 2024 was $54.3 million, reflecting an EBITDA margin of approximately 14.0%. These figures are derived from GenomeDx's audited financial statements for fiscal year 2024, which were prepared by GenomeDx's independent auditors, Whitfield & Garner LLP.

GenomeDx will provide a detailed and complete damages analysis, including updated calculations and supporting methodologies, through the expert report of Dr. Louise Tremaine of Ashworth Economics Group LLC, whose report is due May 15, 2026. GenomeDx expressly reserves the right to supplement this response.

INTERROGATORY NO. 7

State the factual basis for any alternative reasonable-royalty damages theory that GenomeDx intends to assert, including the proposed royalty base, royalty rate, and the factors supporting the proposed rate.

Objection: GenomeDx objects to this interrogatory as a contention interrogatory that is premature to the extent it seeks the full articulation of GenomeDx's reasonable-royalty theory before expert reports are due on May 15, 2026. GenomeDx's response is subject to supplementation following the completion of expert analysis.

Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:

As an alternative to lost profits, or for any portion of Helios's infringing sales for which lost profits cannot be proven (such as the approximately 2,300 non-diverted tests referenced in GenomeDx's response to Interrogatory No. 6), GenomeDx contends it is entitled to a reasonable royalty under 35 U.S.C. § 284. GenomeDx's preliminary reasonable-royalty analysis is as follows:

Royalty Base. The appropriate royalty base is Helios's net revenue from sales of the ProstaSignal™ Genomic Classifier during the period of infringement. For the period from October 2024 through March 2025, GenomeDx estimates Helios's ProstaSignal™ revenue at approximately $32,088,000, based on approximately 8,400 tests performed at an average net reimbursement of $3,820 per test (8,400 × $3,820 = $32,088,000). This estimate is based on information produced by Helios in discovery and publicly available Medicare reimbursement data.

Royalty Rate. GenomeDx proposes a reasonable royalty rate of eighteen percent (18%) of net revenues, based on a hypothetical negotiation between a willing licensor and willing licensee as of the date of first infringement (on or about October 7, 2024). The proposed rate is derived from the following analysis:

• The most relevant comparable license is the Non-Exclusive License Agreement between GenomeDx and Veridian Molecular Labs, Inc., dated April 3, 2022, which provides for a running royalty of fifteen percent (15%) of net revenues for a license under the '271 and '893 Patents limited to the field of bladder cancer diagnostics.

• GenomeDx proposes an upward adjustment of three (3) percentage points from the Veridian royalty rate (from 15% to 18%) to account for the following factors, among others: (i) the hypothetical negotiation in this case takes place in the context of established infringement (i.e., a litigation context), which increases the patentee's bargaining leverage; (ii) the ProstaSignal™ product directly competes with GenomeDx's Decipher® test in the same clinical market (prostate cancer), unlike the Veridian license, which was limited to a non-competitive field (bladder cancer diagnostics); (iii) the value of the patented technology to Helios in the prostate cancer market, where multi-gene prognostic classifiers command premium reimbursement; and (iv) other Georgia-Pacific factors, including the profitability of the patented invention, the extent to which the infringer has made use of the invention, and the portion of the profit or selling price that may be customary in the business to allow for use of the invention.

Royalty Damages. Based on the foregoing, GenomeDx's preliminary reasonable-royalty damages estimate for the October 2024 through March 2025 period is: $32,088,000 × 18% = $5,775,840.

GenomeDx will present its full Georgia-Pacific analysis, including a detailed consideration of all fifteen factors, through the expert report of Dr. Louise Tremaine of Ashworth Economics Group LLC. GenomeDx reserves the right to supplement this response.

INTERROGATORY NO. 8

Identify all documents, data, analyses, and information relied upon by GenomeDx in support of its damages contentions, including lost-profits and reasonable-royalty theories.

Objection: GenomeDx objects to this interrogatory as overly broad and premature to the extent that expert analysis is ongoing and will not be complete until the expert report deadline of May 15, 2026. GenomeDx further objects to the extent this interrogatory is duplicative of document production obligations under Rule 34 and the parties' Initial Disclosures under Rule 26(a)(1). GenomeDx's response is subject to supplementation upon service of the expert report.

Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:

GenomeDx relies upon, among other things, the following categories of documents and information in support of its damages contentions:

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 expects to call at trial or who have knowledge of facts relevant to this action, and for each such witness, state the subject matter of the witness's expected testimony.

Objection: GenomeDx objects to this interrogatory as premature to the extent it seeks a comprehensive trial witness list. GenomeDx will disclose its trial witnesses pursuant to the Scheduling Order and the Court's pretrial requirements. GenomeDx further objects to this interrogatory to the extent it is duplicative of GenomeDx's obligations under Federal Rule of Civil Procedure 26(a)(1) (initial disclosures) and 26(a)(3) (pretrial disclosures).

Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:

Without limitation, and subject to GenomeDx's right to supplement, GenomeDx identifies the following persons with knowledge of facts relevant to this action:

GenomeDx Personnel:

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 classifier development and training methodology; and the scientific basis for GenomeDx's infringement contentions.

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 financial data and damages.

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 reserves the right to supplement this response as additional witnesses are identified through ongoing discovery and investigation, and as pretrial disclosures are made pursuant to the Scheduling Order.

INTERROGATORY NO. 10

State all facts supporting GenomeDx's contention that Helios's infringement of the patents-in-suit was willful, including the basis for any request for enhanced damages under 35 U.S.C. § 284.

Objection: GenomeDx objects to this interrogatory as a contention interrogatory that is subject to supplementation as discovery continues, including discovery relating to Helios's pre-launch knowledge of GenomeDx's patents, Helios's freedom-to-operate analysis, and Helios's decision-making process in launching ProstaSignal™. GenomeDx notes that its Motion to Compel production of 34 documents withheld by Helios on privilege grounds (filed January 30, 2026; Dkt. No. 89) is currently pending before Magistrate Judge Cabrera, and the resolution of that motion may materially affect GenomeDx's willfulness contentions.

Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:

GenomeDx contends that Helios's infringement of the patents-in-suit was willful, and that GenomeDx is entitled to enhanced damages under 35 U.S.C. § 284, based on the following facts, among others:

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 peer-reviewed literature, trade conference presentations, and industry coverage. GenomeDx contends that Helios, as a direct competitor in the same niche market, was aware of GenomeDx's patents prior to launching ProstaSignal™.

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 attorney-client privilege and work-product protection. GenomeDx has challenged Helios's privilege assertions with respect to thirty-four (34) such documents in its Motion to Compel filed on January 30, 2026 (Dkt. No. 89), which is pending before Magistrate Judge Cabrera.

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 Electronics, Inc., 579 U.S. 93 (2016).

GenomeDx reserves the right to supplement this response based on documents and testimony obtained through continued discovery, including the resolution of the pending Motion to Compel and deposition testimony from Helios witnesses, including Dr. Nathan Ashford, Dr. Elaine Kossack, and Sara Whitmore.

INTERROGATORY NO. 11

Identify all prior art that GenomeDx is aware of that is or may be relevant to the validity of the asserted claims of the patents-in-suit.

Objection: GenomeDx objects to this interrogatory as overly broad and improperly shifting the burden of proof on validity. GenomeDx is the patent holder, and the asserted claims of the patents-in-suit are entitled to a presumption of validity under 35 U.S.C. § 282. It is Defendant's burden to prove invalidity by clear and convincing evidence. GenomeDx has no obligation to identify or catalogue all prior art that might be "relevant" to validity. GenomeDx further objects to the extent this interrogatory calls for legal conclusions as to the relevance of any particular prior art reference to the validity of any particular claim.

Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:

Without waiving the statutory presumption of validity under 35 U.S.C. § 282, and without assuming any burden to establish validity, GenomeDx identifies the following prior art references that were cited during prosecution of the patents-in-suit, as reflected in the prosecution file histories:

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 withdrew the rejection and allowed the claims.

GenomeDx is also aware that Helios has identified the following references in its invalidity contentions served pursuant to Patent Local Rule 3-3:

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's invalidity contentions in his expert report, due May 15, 2026.

GenomeDx reserves the right to supplement this response as additional prior art references come to its attention through the course of discovery.

INTERROGATORY NO. 12

State all facts supporting GenomeDx's contention that the asserted claims of the patents-in-suit are valid, including GenomeDx's response to Helios's invalidity arguments under 35 U.S.C. §§ 101, 102, and 103.

Objection: GenomeDx objects to this interrogatory as a contention interrogatory seeking legal conclusions regarding the validity of GenomeDx's patents. The asserted claims of the patents-in-suit are presumed valid under 35 U.S.C. § 282, and the burden of proving invalidity rests with Defendant by clear and convincing evidence. GenomeDx further objects to this interrogatory to the extent it is premature, as claim construction has not yet been completed and expert reports are not due until May 15, 2026. GenomeDx additionally notes that the question of patent-eligible subject matter under § 101 was the subject of Helios's Motion to Dismiss (Dkt. No. 42), which was denied by the Court on January 13, 2026 (Dkt. No. 67).

Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:

GenomeDx contends that all asserted claims of the '271 Patent, '893 Patent, and '647 Patent are valid under 35 U.S.C. §§ 101, 102, 103, and 112, and under all other provisions of the Patent Act.

With respect to § 101 (Patent-Eligible Subject Matter):

The asserted claims are directed to specific, concrete, and technically defined diagnostic improvements rather than to abstract ideas, laws of nature, or natural phenomena. The claims recite particular technical steps that constitute a practical application of genomic technology, including: (i) extraction of RNA from formalin-fixed paraffin-embedded (FFPE) prostate tumor tissue; (ii) measurement of expression levels of a defined panel of at least 22 genes; (iii) normalization of expression data using a reference gene panel; (iv) application of specific trained machine-learning classifiers (including random-forest classifiers trained on defined patient cohorts); and (v) generation of actionable, quantitative prognostic reports combining genomic and clinical data that are transmitted to healthcare providers for use in treatment decisions.

These claims were examined and allowed by the United States Patent and Trademark Office, including after initial § 101 rejections (in the '271 Patent prosecution) were overcome through claim amendments adding specific technical steps that the Examiner agreed constituted patent-eligible subject matter under the Mayo/Alice framework. The claims recite an inventive concept — the specific combination of gene panel, classifier algorithm, training methodology, and clinical integration — that transforms any underlying natural correlation into a practical and technologically defined diagnostic tool.

The Court denied Helios's Motion to Dismiss under § 101 on January 13, 2026 (Dkt. No. 67), holding that § 101 challenges to the asserted claims were premature without the benefit of full claim construction, and that the claims, as pleaded, were plausibly directed to patent-eligible subject matter. GenomeDx contends that the Court's reasoning further supports the validity of the asserted claims.

With respect to §§ 102 and 103 (Novelty and Non-Obviousness):

The asserted claims are novel and non-obvious over the prior art. The prior art references identified by Helios in its invalidity contentions — including Thornberry et al. (2015) and Klein et al. (2014) — do not anticipate or render obvious the asserted claims, individually or in combination. The specific combination of claim elements, including the defined gene panel, the trained ensemble machine-learning classifier, the minimum training cohort requirement, the reference-gene normalization methodology, and the integration of genomic and clinical covariates, was not disclosed or suggested by the prior art. GenomeDx's technical expert will address these issues in detail in his expert report.

GenomeDx will further address the validity of the asserted claims through its technical expert's report, due May 15, 2026. GenomeDx reserves the right to supplement this response.

INTERROGATORY NO. 13

Describe the prosecution history for each patent-in-suit, including all amendments to the claims, arguments made to the Examiner, and any declarations or other evidence submitted during prosecution.

Objection: GenomeDx objects to this interrogatory as unduly burdensome and seeking information that is publicly available. The complete prosecution file histories of the patents-in-suit are publicly available from the United States Patent and Trademark Office through its Patent Application Information Retrieval (PAIR) system, and those records speak for themselves. Requiring GenomeDx to prepare a narrative restatement of the full prosecution histories — which span hundreds of pages — is unduly burdensome and disproportionate to the needs of the case when the original records are equally available to both parties.

Response: Subject to and without waiv

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA
DRAFT — FOR INTERNAL REVIEW ONLY — NOT YET SERVED ON OPPOSING COUNSEL Draft Date: February 2026 Prepared by: Peter Vassiliev and Wendy Schultz, Calderwood & Harkness LLP 555 Mission Street, Suite 3100, San Francisco, CA 94105 For review by: Catherine Bloom (Responsible Partner) and Victoria Sung (GenomeDx General Counsel) NOTE: Responses subject to verification by GenomeDx corporate representative prior to service.
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 the Local Rules of the United States District Court for the Northern District of California.
These responses are made based upon information reasonably available to GenomeDx as of the date of service of these responses and are made without prejudice to GenomeDx's right to supplement, amend, or correct its responses as additional information becomes available through the ongoing course of discovery in this action, including but not limited to information obtained through document production, depositions, third-party discovery, and expert analysis.
Discovery in this matter is ongoing. Fact discovery is currently scheduled to close on March 6, 2026, pursuant to the Scheduling Order entered on June 18, 2025 by the Honorable Jessica W. Langston. Expert reports are due on May 15, 2026, and rebuttal expert reports are due on July 10, 2026. GenomeDx expressly reserves the right to supplement and amend its responses and objections in accordance with the continuing obligation to supplement imposed by Federal Rule of Civil Procedure 26(e) and any orders of this Court.
The responses set forth herein are based on GenomeDx's current understanding of the facts and applicable law. No response herein shall be deemed an admission of the relevance, materiality, or admissibility of any interrogatory or of the subject matter to which any interrogatory relates. GenomeDx's investigation is continuing, and it should not be assumed that GenomeDx has completed its factual or legal analysis with respect to any of the matters addressed herein.
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 Definitions and Instructions accompanying Defendant's First Set of Interrogatories, to the extent any such interrogatory is overly broad, unduly burdensome, or not proportional to the needs of this case as required by Federal Rule of Civil Procedure 26(b)(1). In assessing proportionality, GenomeDx has considered the importance of the issues at stake in this action, the amount in controversy, the parties' relative access to relevant information, the parties' resources, the importance of the discovery in resolving the issues, and whether the burden or expense of the proposed discovery outweighs its likely benefit. GenomeDx has endeavored to respond to the extent each interrogatory is reasonably construed and proportional to the needs of the case, but objects to any construction that would impose obligations exceeding those boundaries.
B. Objection Regarding Attorney-Client Privilege and Work Product
GenomeDx objects to each and every interrogatory to the extent it calls for or seeks information, communications, or documents protected by the attorney-client privilege, the attorney work-product doctrine, the joint defense or common interest privilege, or any other applicable privilege or immunity from disclosure. GenomeDx does not intend by these responses to waive, and does not waive, any such privilege or protection. No inadvertent production or disclosure of any privileged or protected information shall operate as a waiver of any privilege or protection, whether in this proceeding or in any other proceeding, consistent with (i) the Stipulated Protective Order entered by the Court on December 18, 2025, (ii) any order entered pursuant to Federal Rule of Evidence 502(d), and (iii) Federal Rule of Civil Procedure 26(b)(5)(B).
C. Objection Regarding Premature Contention Interrogatories
GenomeDx objects to each interrogatory that constitutes or includes a contention interrogatory, to the extent it seeks expert opinions, legal conclusions, or legal theories that have not yet been fully developed. Discovery in this action is ongoing. Expert reports are not due until May 15, 2026, pursuant to the Scheduling Order entered June 18, 2025. Claim construction proceedings are pending. To the extent GenomeDx responds to contention interrogatories, it does so based on its current understanding and contentions, which are expressly subject to supplementation, amendment, and refinement as discovery continues, as expert analyses are completed, and as claim construction issues are resolved by the Court. GenomeDx's responses to contention interrogatories should not be construed as a complete or final statement of its positions.
D. Objection Regarding Claim Construction
GenomeDx objects to each and every interrogatory to the extent it requires, assumes, or presupposes a particular construction of any claim term of the patents-in-suit, U.S. Patent Nos. 10,438,271, 11,204,893, and 11,891,647. The parties exchanged proposed claim construction terms and their proposed constructions on August 4, 2025, and the Markman hearing before the Honorable Jessica W. Langston is not scheduled until September 18, 2026. GenomeDx's responses herein are based upon GenomeDx's proposed claim constructions and do not constitute admissions as to the scope or meaning of any claim term. GenomeDx reserves the right to modify, supplement, or amend its responses following the Court's claim construction ruling.
E. Objection Regarding Definitions and Instructions
GenomeDx objects to Defendant's Definitions and Instructions accompanying its First Set of Interrogatories to the extent they purport to impose obligations beyond those required by the Federal Rules of Civil Procedure, the Local Rules of the United States District Court for the Northern District of California, or the Patent Local Rules. GenomeDx will construe Defendant's interrogatories in accordance with the Federal Rules, Local Rules, and Patent Local Rules, and responds on that basis.
F. Reservation of Rights
By responding to Defendant's First Set of Interrogatories, GenomeDx does not waive, and expressly reserves, any objection to the admissibility, relevance, or materiality of the interrogatories or the subject matter to which they relate. GenomeDx further reserves the right to assert additional objections, defenses, claims, and contentions as discovery progresses, as claim construction proceedings are conducted, and as expert analysis is completed. Subject to and without waiving these General Objections, GenomeDx responds to each interrogatory as set forth below.
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 interrogatory to the extent it is overly broad and seeks all factual and legal bases for each infringement contention at this preliminary stage of the litigation. This interrogatory constitutes a contention interrogatory, and GenomeDx's response is subject to supplementation following the Markman hearing on claim construction, currently scheduled for September 18, 2026, and following service of expert reports on May 15, 2026. GenomeDx further objects to this interrogatory to the extent it is duplicative of the infringement contentions and claim charts served by GenomeDx pursuant to Patent Local Rule 3-1, which provide detailed element-by-element mapping of each asserted claim to the accused ProstaSignal™ product.
Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:
GenomeDx contends that Helios's ProstaSignal™ Genomic Classifier infringes the following claims of the patents-in-suit:
• U.S. Patent No. 10,438,271 ("the '271 Patent"): Claims 1, 3, 5, 7, 12, and 18.
• U.S. Patent No. 11,204,893 ("the '893 Patent"): Claims 1, 2, 9, 14, and 20.
• U.S. Patent No. 11,891,647 ("the '647 Patent"): Claims 1, 4, 6, 11, and 15.
GenomeDx's infringement theories are set forth in detail in the Complaint filed March 28, 2025 (Dkt. No. 1) and in the claim charts served with GenomeDx's infringement contentions on September 5, 2025, pursuant to Patent Local Rule 3-1, which GenomeDx incorporates by reference herein. GenomeDx's infringement contentions were further amended on November 14, 2025, in accordance with Patent Local Rule 3-6.
In summary, and without limitation, GenomeDx's infringement contentions are based on the following factual grounds: Helios's ProstaSignal™ Genomic Classifier (i) uses a 24-gene expression panel to analyze tumor tissue from prostate cancer patients, 19 of which genes overlap with the gene set identified and claimed in GenomeDx's patents-in-suit; (ii) employs a trained machine-learning classifier, specifically a gradient-boosted decision tree algorithm, to generate a numerical prognostic score (referred to by Helios as a "ProstaScore," ranging from 0 to 100); (iii) classifies patients into Low, Intermediate, or High risk categories based on the ProstaScore; and (iv) combines the ProstaScore with clinical covariates including, at minimum, Gleason grade group and pre-operative prostate-specific antigen (PSA) level to generate an integrated prognostic report that is transmitted to the ordering healthcare provider.
With respect to the '893 Patent, which recites a "random-forest classifier" in certain claims, GenomeDx contends that Helios's gradient-boosted decision tree classifier literally infringes the asserted claims under a proper construction of the term "random-forest classifier," which GenomeDx contends encompasses ensemble machine-learning methods that aggregate the outputs of multiple decision trees. Alternatively, GenomeDx contends that Helios's gradient-boosted decision tree infringes the asserted claims of the '893 Patent under the doctrine of equivalents, as described in further detail in GenomeDx's response to Interrogatory No. 3 below.
GenomeDx reserves the right to supplement this response following the Markman hearing on September 18, 2026, and following service of its technical expert report on May 15, 2026. GenomeDx further reserves the right to assert additional claims of infringement, including additional claims or additional theories of infringement, as discovery continues.
INTERROGATORY NO. 2
For each claim of each patent-in-suit that GenomeDx contends is infringed by ProstaSignal™, identify the specific element, component, feature, step, or limitation of ProstaSignal™ that GenomeDx contends meets each limitation of the asserted claim.
Objection: GenomeDx objects to this interrogatory as duplicative of the element-by-element claim charts served by GenomeDx in compliance with Patent Local Rule 3-1 on September 5, 2025, as amended on November 14, 2025. Those claim charts were specifically designed to and do identify, for each asserted claim, the specific element, component, feature, step, or limitation of ProstaSignal™ that meets each limitation. Requiring GenomeDx to restate that element-by-element mapping in narrative form is unduly burdensome and serves no legitimate discovery purpose not already satisfied by the Patent Local Rule disclosures. GenomeDx further objects to this interrogatory as overly broad and disproportionate to the needs of the case.
Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:
GenomeDx refers to and incorporates by reference its claim charts for the '271 Patent, '893 Patent, and '647 Patent, which provide detailed element-by-element mapping of each asserted claim against the ProstaSignal™ Genomic Classifier. These charts were served in compliance with Patent Local Rules 3-1 and 3-6 and constitute the most detailed and accurate statement of GenomeDx's element-by-element infringement contentions at this time. GenomeDx will supplement this interrogatory response to the extent its claim charts are updated following claim construction proceedings or the completion of expert analysis.
Without limitation, and by way of summary only, the key element-by-element mappings for representative independent claims include the following:
'271 Patent, Claim 1:
(a) A method for generating a prognostic score from a biological sample containing tumor RNA — ProstaSignal™ is a method that generates a prognostic score (ProstaScore) from a biological sample containing tumor RNA. Specifically, ProstaSignal™ uses formalin-fixed paraffin-embedded (FFPE) prostate tumor tissue from which RNA is extracted using proprietary extraction protocols prior to analysis.
(b) Measuring expression levels of a panel of at least 22 genes — ProstaSignal™ measures the expression levels of a 24-gene panel. Nineteen (19) of those genes are from GenomeDx's predefined gene set as identified in the '271 Patent specification. The remaining five genes include three reference genes and two genes identified in published literature co-authored by former GenomeDx collaborators.
(c) Applying a trained machine-learning classifier to the measured expression levels — ProstaSignal™ applies a trained machine-learning classifier, specifically a gradient-boosted decision tree algorithm, to the measured gene expression levels to generate the ProstaScore.
(d) Classifying the patient into one of at least three risk categories based on the output of the machine-learning classifier — ProstaSignal™ classifies patients into three risk categories — Low, Intermediate, and High — based on the ProstaScore.
'893 Patent, Claim 1:
(a) Normalizing expression data using a reference gene panel — ProstaSignal™ performs reference-gene normalization using at least three reference genes (GAPDH, ARF1, and ATP5E, or equivalents thereof) prior to application of the classifier algorithm.
(b) Applying a random-forest classifier trained on a cohort of at least 500 patient samples — Literally met under GenomeDx's proposed construction of "random-forest classifier," which encompasses ensemble methods aggregating outputs of multiple decision trees, including gradient-boosted decision trees; or, alternatively, met under the doctrine of equivalents because Helios's gradient-boosted decision tree performs substantially the same function, in substantially the same way, to achieve substantially the same result as a random-forest classifier. The ProstaSignal™ classifier was trained on a cohort of approximately 1,200 patient samples from six academic medical centers, meeting the "at least 500 patient samples" limitation.
(c) Generating a numerical prognostic score correlated with the probability of metastasis within 5 years of initial diagnosis — The ProstaScore (ranging from 0 to 100) is correlated with the probability of metastasis within five years following radical prostatectomy.
'647 Patent, Claim 1:
(a) A method for generating an integrated prognostic assessment combining biomarker data and clinical variable data — ProstaSignal™ combines the gene-expression-derived ProstaScore with at least two clinical covariates (Gleason grade group and pre-operative PSA level) to generate an integrated prognostic assessment.
(b) Generating an integrated prognostic report transmitted to a healthcare provider — ProstaSignal™ generates a prognostic report that is transmitted electronically to the ordering healthcare provider, typically a urologist or radiation oncologist, via Helios's proprietary reporting portal and/or integration with the provider's electronic health record (EHR) system.
GenomeDx reserves the right to supplement these mappings as claim construction proceedings and expert analysis continue.
INTERROGATORY NO. 3
State the factual and technical basis for GenomeDx's contention that Helios's use of a gradient-boosted decision tree classifier in the ProstaSignal™ product infringes claims of the '893 Patent that recite a "random-forest classifier," including whether infringement is alleged literally, under the doctrine of equivalents, or both.
Objection: GenomeDx objects to this interrogatory as a contention interrogatory that seeks expert opinions and technical analyses that have not yet been fully developed. GenomeDx's full theory regarding the relationship between gradient-boosted decision trees and random-forest classifiers will be articulated through expert testimony in the report of GenomeDx's technical expert, Dr. Franklin Ogawa, which is due May 15, 2026. GenomeDx responds to the extent of its current contentions, subject to supplementation.
Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:
GenomeDx contends that the term "random-forest classifier" as used in the asserted claims of the '893 Patent, properly construed, encompasses ensemble machine-learning methods that aggregate the outputs of multiple decision trees to generate a prediction, which includes gradient-boosted decision tree classifiers of the type used in Helios's ProstaSignal™ product. GenomeDx's proposed construction of "random-forest classifier" is set forth in GenomeDx's claim construction brief, which was served on the parties on August 4, 2025. GenomeDx contends that the '893 Patent specification uses the term "random-forest classifier" to describe the general category of ensemble tree-based methods, and that a person of ordinary skill in the art at the time of the invention would have understood the term to encompass gradient-boosted decision tree methods.
Alternatively, even if the term "random-forest classifier" is construed narrowly to be limited to the classical random-forest algorithm as described in Breiman (2001), GenomeDx contends that Helios's gradient-boosted decision tree classifier infringes the asserted claims of the '893 Patent under the doctrine of equivalents. Specifically:
• Function: Helios's gradient-boosted decision tree performs substantially the same function as a random-forest classifier — namely, aggregating predictions from an ensemble of decision trees trained on patient cohort data to generate a numerical prognostic score.
• Way: Helios's gradient-boosted decision tree operates in substantially the same way as a random-forest classifier — namely, by sequentially building and combining multiple decision-tree models using training data from patient cohorts, wherein each tree in the ensemble contributes to the final prediction. While the classical random-forest algorithm builds trees in parallel using bootstrapped samples and random feature subsets, and the gradient-boosted decision tree algorithm builds trees sequentially with each tree correcting the errors of the prior trees, both methods fundamentally operate by constructing and aggregating ensembles of decision trees from the same type of training data (gene expression measurements from patient cohorts).
• Result: Helios's gradient-boosted decision tree achieves substantially the same result as a random-forest classifier — namely, a numerical prognostic score (the ProstaScore) correlated with the probability of metastasis within five years, which is used to classify patients into risk categories. Published literature, including Helios's own peer-reviewed validation study (Ashford et al., Journal of Clinical Oncology, Vol. 42, No. 28, pp. 3311–3319 (2024)), demonstrates that the predictive performance of ProstaSignal™ is statistically comparable to that of classifiers employing random-forest algorithms in the same clinical context.
GenomeDx further contends that the doctrine of equivalents is not barred by prosecution history estoppel with respect to the '893 Patent. During prosecution, the claims of the '893 Patent were narrowed from reciting a generic "machine-learning classifier" to reciting a "random-forest classifier" to overcome a § 102 rejection based on the Nakamura reference, which disclosed a single-tree logistic model tree classifier. Gradient-boosted decision trees are ensemble tree-based methods that are not within the territory surrendered by the narrowing amendment, because the amendment was directed to distinguishing single-tree classifiers, not other ensemble tree-based methods.
GenomeDx will supplement this response with expert testimony from Dr. Franklin Ogawa, Professor of Computational Oncology at Stanford University, whose expert report is due May 15, 2026.
INTERROGATORY NO. 4
Identify all persons with knowledge of the conception, development, reduction to practice, and/or patenting of each patent-in-suit, including, for each person, a summary of that person's involvement and current contact information, if known.
Objection: GenomeDx objects to this interrogatory as overly broad to the extent it seeks information regarding every person who may have had any involvement, however peripheral, in the conception, development, reduction to practice, or patenting of the patents-in-suit. GenomeDx further objects to the extent this interrogatory seeks privileged attorney-client communications relating to patent prosecution strategy. Subject to these objections, GenomeDx responds with respect to persons with material knowledge.
Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:
The following persons have knowledge of the conception, development, and/or reduction to practice of one or more of the patents-in-suit:
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 integration of clinical covariates into the combined prognostic model. Dr. Mehta has been employed by GenomeDx since 2012 and can be contacted through undersigned counsel.
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 of the gene panel. Dr. Xu's last known contact information is care of Cascadia Genomics, Inc., 1501 Elliott Avenue West, Suite 200, Seattle, WA 98119.
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 supplement this response if his current information is obtained.
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. Shah can be contacted through undersigned counsel.
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 decision to pursue patent protection and its commercialization of the Decipher® test. Dr. Langford can be contacted through undersigned counsel.
GenomeDx reserves the right to supplement this response as additional witnesses are identified through ongoing discovery and investigation.
INTERROGATORY NO. 5
Identify all licenses, sublicenses, assignments, agreements, or other transactions relating to any of the patents-in-suit, including the parties thereto, the date of execution, the scope of the rights granted, and any financial terms.
Objection: GenomeDx objects to this interrogatory to the extent it seeks information protected by the attorney-client privilege, the work-product doctrine, or the terms of confidential third-party agreements beyond what is relevant to the claims and defenses in this litigation. GenomeDx further objects to this interrogatory to the extent it seeks financial or business terms of agreements that are subject to confidentiality provisions with third parties, and to the extent it is overly broad in seeking information regarding "other transactions" without meaningful limitation. GenomeDx responds to the extent the interrogatory seeks information regarding licenses and similar agreements that are relevant to the issues in this case, including damages.
Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:
GenomeDx identifies the following license agreement relating to the patents-in-suit:
Non-Exclusive License Agreement dated April 3, 2022, between GenomeDx Therapeutics Inc. (as licensor) and Veridian Molecular Labs, Inc. (as licensee). This agreement grants Veridian a non-exclusive license under the '271 Patent and the '893 Patent for use in Veridian's bladder cancer diagnostic product (a clinical application distinct from the prostate cancer application at issue in this litigation). The license provides for a running royalty of fifteen percent (15%) of net revenues derived from licensed products, with a minimum annual royalty of Five Hundred Thousand Dollars ($500,000). The term of the license is co-extensive with the patent life of the licensed patents. The licensed field is expressly limited to bladder cancer diagnostics, and the license does not extend to prostate cancer diagnostics or any other clinical application. The agreement was produced to Helios on December 2, 2025, as Bates No. GDX-00024781 through GDX-00024812, subject to the Confidentiality provisions of the Stipulated Protective Order.
Other than the foregoing, GenomeDx is not aware of any other licenses, sublicenses, assignments, or agreements with third parties relating to the patents-in-suit, other than (i) invention assignment agreements between GenomeDx and its employees and co-inventors, executed in the ordinary course of the employment relationship, pursuant to which the named inventors assigned their rights in the inventions to GenomeDx, and (ii) agreements between GenomeDx and its outside patent prosecution counsel, which are protected by the attorney-client privilege.
GenomeDx reserves the right to supplement this response as discovery continues.
INTERROGATORY NO. 6
State all facts supporting GenomeDx's lost-profits damages theory, including but not limited to market share data, pricing information, margin calculations, the basis for any assertion of a two-supplier market, and the total amount of lost-profits damages claimed.
Objection: GenomeDx objects to this interrogatory as a contention interrogatory that is premature to the extent it seeks the full articulation of GenomeDx's damages theory before expert reports are due on May 15, 2026. GenomeDx's damages expert, Dr. Louise Tremaine of Ashworth Economics Group LLC, has not yet completed her analysis, and her expert report will set forth GenomeDx's detailed damages contentions. GenomeDx's response is subject to supplementation following the completion of expert analysis. GenomeDx further objects to this interrogatory as overly broad and unduly burdensome in its demand for "all facts" supporting a complex economic theory.
Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:
GenomeDx contends it is entitled to lost profits as its primary measure of damages under 35 U.S.C. § 284, based on the following facts and contentions, which are preliminary and subject to supplementation:
Market Share. GenomeDx is the market leader in genomic prostate cancer prognostic testing. Prior to the launch of Helios's ProstaSignal™ Genomic Classifier on or about October 7, 2024, GenomeDx held approximately seventy-four percent (74%) of the U.S. market for genomic prostate cancer prognostic classifiers, as measured by test volume. Following the launch of ProstaSignal™, GenomeDx's market share declined to approximately sixty-eight percent (68%) through March 2025. This market share data is based on GenomeDx's internal commercial analyses, Medicare claims data for MAAA codes 0047M (Decipher®) and 0239M (ProstaSignal™), and publicly available industry reports.
Demand for the Patented Product. GenomeDx's Decipher® test and Helios's ProstaSignal™ are directly competing products in the same clinical niche — specifically, post-radical prostatectomy prostate cancer prognosis and treatment decision support. Both tests use multi-gene expression panels and machine-learning classifiers to generate prognostic risk scores from FFPE prostate tumor tissue, and both are ordered by urologists and radiation oncologists for the same patient population. GenomeDx contends that, absent Helios's infringement, a substantial portion of the ProstaSignal™ test volume would have been performed using GenomeDx's Decipher® test.
Two-Supplier Market. GenomeDx contends that the relevant market for genomic prostate cancer prognostic classifiers using multi-gene expression panels and machine-learning classifiers was effectively a two-supplier market following ProstaSignal™'s commercial launch in October 2024, with GenomeDx (Decipher®) and Helios (ProstaSignal™) as the primary competitors for the specific clinical indication of post-prostatectomy genomic risk stratification. While other genomic prostate cancer tests exist (such as the Oncotype DX Genomic Prostate Score® test and the Prolaris® test), GenomeDx contends that those tests serve different clinical niches (e.g., biopsy-based active surveillance decisions rather than post-prostatectomy treatment intensification decisions), have different gene panels, and are not close substitutes for Decipher® or ProstaSignal™ in the post-prostatectomy setting.
Diverted Tests. GenomeDx estimates that approximately 6,100 of Helios's approximately 8,400 ProstaSignal™ tests performed during the period from October 2024 through March 2025 would have been performed by GenomeDx using the Decipher® test absent Helios's infringement. This estimate is based on GenomeDx's pre-infringement market share, the degree of substitutability between the two products, and an analysis of ordering physician patterns. The remaining approximately 2,300 tests represent market expansion attributable to Helios's marketing efforts and physicians who would not have ordered any genomic prognostic test absent ProstaSignal™.
Pricing. GenomeDx's average net reimbursement per Decipher® test in fiscal year 2024 was $4,210, based on a blended average of Medicare reimbursement, commercial payor reimbursement, and institutional pricing. This figure is derived from GenomeDx's audited financial statements and internal revenue data.
Estimated Lost Revenue. Based on the foregoing, GenomeDx's preliminary estimate of lost revenue for the October 2024 through March 2025 period is: 6,100 diverted tests × $4,210 average reimbursement per test = $25,681,000.
Incremental Margin. GenomeDx's incremental profit margin on additional test volume is approximately seventy-two percent (72%). This margin reflects the incremental costs that GenomeDx would have incurred to process the additional 6,100 tests, including reagent costs, laboratory consumables, labor, and shipping, while excluding fixed costs (facilities, equipment depreciation, general and administrative overhead) that are already absorbed by GenomeDx's existing test volume. GenomeDx's incremental margin is higher than its overall EBITDA margin because fixed costs are already covered at GenomeDx's current production levels.
Estimated Lost Profits. GenomeDx's preliminary estimate of lost profits for the October 2024 through March 2025 period is: $25,681,000 × 72% = $18,490,320. This estimate is preliminary and subject to adjustment based on updated test volume data, further analysis of diverted demand, and the expert analysis of Dr. Louise Tremaine.
Revenue and Financial Data. For context, GenomeDx's total revenue for fiscal year 2024 was $387.6 million. GenomeDx's EBITDA for fiscal year 2024 was $54.3 million, reflecting an EBITDA margin of approximately 14.0%. These figures are derived from GenomeDx's audited financial statements for fiscal year 2024, which were prepared by GenomeDx's independent auditors, Whitfield & Garner LLP.
GenomeDx will provide a detailed and complete damages analysis, including updated calculations and supporting methodologies, through the expert report of Dr. Louise Tremaine of Ashworth Economics Group LLC, whose report is due May 15, 2026. GenomeDx expressly reserves the right to supplement this response.
INTERROGATORY NO. 7
State the factual basis for any alternative reasonable-royalty damages theory that GenomeDx intends to assert, including the proposed royalty base, royalty rate, and the factors supporting the proposed rate.
Objection: GenomeDx objects to this interrogatory as a contention interrogatory that is premature to the extent it seeks the full articulation of GenomeDx's reasonable-royalty theory before expert reports are due on May 15, 2026. GenomeDx's response is subject to supplementation following the completion of expert analysis.
Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:
As an alternative to lost profits, or for any portion of Helios's infringing sales for which lost profits cannot be proven (such as the approximately 2,300 non-diverted tests referenced in GenomeDx's response to Interrogatory No. 6), GenomeDx contends it is entitled to a reasonable royalty under 35 U.S.C. § 284. GenomeDx's preliminary reasonable-royalty analysis is as follows:
Royalty Base. The appropriate royalty base is Helios's net revenue from sales of the ProstaSignal™ Genomic Classifier during the period of infringement. For the period from October 2024 through March 2025, GenomeDx estimates Helios's ProstaSignal™ revenue at approximately $32,088,000, based on approximately 8,400 tests performed at an average net reimbursement of $3,820 per test (8,400 × $3,820 = $32,088,000). This estimate is based on information produced by Helios in discovery and publicly available Medicare reimbursement data.
Royalty Rate. GenomeDx proposes a reasonable royalty rate of eighteen percent (18%) of net revenues, based on a hypothetical negotiation between a willing licensor and willing licensee as of the date of first infringement (on or about October 7, 2024). The proposed rate is derived from the following analysis:
• The most relevant comparable license is the Non-Exclusive License Agreement between GenomeDx and Veridian Molecular Labs, Inc., dated April 3, 2022, which provides for a running royalty of fifteen percent (15%) of net revenues for a license under the '271 and '893 Patents limited to the field of bladder cancer diagnostics.
• GenomeDx proposes an upward adjustment of three (3) percentage points from the Veridian royalty rate (from 15% to 18%) to account for the following factors, among others: (i) the hypothetical negotiation in this case takes place in the context of established infringement (i.e., a litigation context), which increases the patentee's bargaining leverage; (ii) the ProstaSignal™ product directly competes with GenomeDx's Decipher® test in the same clinical market (prostate cancer), unlike the Veridian license, which was limited to a non-competitive field (bladder cancer diagnostics); (iii) the value of the patented technology to Helios in the prostate cancer market, where multi-gene prognostic classifiers command premium reimbursement; and (iv) other Georgia-Pacific factors, including the profitability of the patented invention, the extent to which the infringer has made use of the invention, and the portion of the profit or selling price that may be customary in the business to allow for use of the invention.
Royalty Damages. Based on the foregoing, GenomeDx's preliminary reasonable-royalty damages estimate for the October 2024 through March 2025 period is: $32,088,000 × 18% = $5,775,840.
GenomeDx will present its full Georgia-Pacific analysis, including a detailed consideration of all fifteen factors, through the expert report of Dr. Louise Tremaine of Ashworth Economics Group LLC. GenomeDx reserves the right to supplement this response.
INTERROGATORY NO. 8
Identify all documents, data, analyses, and information relied upon by GenomeDx in support of its damages contentions, including lost-profits and reasonable-royalty theories.
Objection: GenomeDx objects to this interrogatory as overly broad and premature to the extent that expert analysis is ongoing and will not be complete until the expert report deadline of May 15, 2026. GenomeDx further objects to the extent this interrogatory is duplicative of document production obligations under Rule 34 and the parties' Initial Disclosures under Rule 26(a)(1). GenomeDx's response is subject to supplementation upon service of the expert report.
Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:
GenomeDx relies upon, among other things, the following categories of documents and information in support of its damages contentions:
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 expects to call at trial or who have knowledge of facts relevant to this action, and for each such witness, state the subject matter of the witness's expected testimony.
Objection: GenomeDx objects to this interrogatory as premature to the extent it seeks a comprehensive trial witness list. GenomeDx will disclose its trial witnesses pursuant to the Scheduling Order and the Court's pretrial requirements. GenomeDx further objects to this interrogatory to the extent it is duplicative of GenomeDx's obligations under Federal Rule of Civil Procedure 26(a)(1) (initial disclosures) and 26(a)(3) (pretrial disclosures).
Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:
Without limitation, and subject to GenomeDx's right to supplement, GenomeDx identifies the following persons with knowledge of facts relevant to this action:
GenomeDx Personnel:
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 classifier development and training methodology; and the scientific basis for GenomeDx's infringement contentions.
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 financial data and damages.
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 reserves the right to supplement this response as additional witnesses are identified through ongoing discovery and investigation, and as pretrial disclosures are made pursuant to the Scheduling Order.
INTERROGATORY NO. 10
State all facts supporting GenomeDx's contention that Helios's infringement of the patents-in-suit was willful, including the basis for any request for enhanced damages under 35 U.S.C. § 284.
Objection: GenomeDx objects to this interrogatory as a contention interrogatory that is subject to supplementation as discovery continues, including discovery relating to Helios's pre-launch knowledge of GenomeDx's patents, Helios's freedom-to-operate analysis, and Helios's decision-making process in launching ProstaSignal™. GenomeDx notes that its Motion to Compel production of 34 documents withheld by Helios on privilege grounds (filed January 30, 2026; Dkt. No. 89) is currently pending before Magistrate Judge Cabrera, and the resolution of that motion may materially affect GenomeDx's willfulness contentions.
Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:
GenomeDx contends that Helios's infringement of the patents-in-suit was willful, and that GenomeDx is entitled to enhanced damages under 35 U.S.C. § 284, based on the following facts, among others:
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 peer-reviewed literature, trade conference presentations, and industry coverage. GenomeDx contends that Helios, as a direct competitor in the same niche market, was aware of GenomeDx's patents prior to launching ProstaSignal™.
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 attorney-client privilege and work-product protection. GenomeDx has challenged Helios's privilege assertions with respect to thirty-four (34) such documents in its Motion to Compel filed on January 30, 2026 (Dkt. No. 89), which is pending before Magistrate Judge Cabrera.
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 Electronics, Inc., 579 U.S. 93 (2016).
GenomeDx reserves the right to supplement this response based on documents and testimony obtained through continued discovery, including the resolution of the pending Motion to Compel and deposition testimony from Helios witnesses, including Dr. Nathan Ashford, Dr. Elaine Kossack, and Sara Whitmore.
INTERROGATORY NO. 11
Identify all prior art that GenomeDx is aware of that is or may be relevant to the validity of the asserted claims of the patents-in-suit.
Objection: GenomeDx objects to this interrogatory as overly broad and improperly shifting the burden of proof on validity. GenomeDx is the patent holder, and the asserted claims of the patents-in-suit are entitled to a presumption of validity under 35 U.S.C. § 282. It is Defendant's burden to prove invalidity by clear and convincing evidence. GenomeDx has no obligation to identify or catalogue all prior art that might be "relevant" to validity. GenomeDx further objects to the extent this interrogatory calls for legal conclusions as to the relevance of any particular prior art reference to the validity of any particular claim.
Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:
Without waiving the statutory presumption of validity under 35 U.S.C. § 282, and without assuming any burden to establish validity, GenomeDx identifies the following prior art references that were cited during prosecution of the patents-in-suit, as reflected in the prosecution file histories:
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 withdrew the rejection and allowed the claims.
GenomeDx is also aware that Helios has identified the following references in its invalidity contentions served pursuant to Patent Local Rule 3-3:
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's invalidity contentions in his expert report, due May 15, 2026.
GenomeDx reserves the right to supplement this response as additional prior art references come to its attention through the course of discovery.
INTERROGATORY NO. 12
State all facts supporting GenomeDx's contention that the asserted claims of the patents-in-suit are valid, including GenomeDx's response to Helios's invalidity arguments under 35 U.S.C. §§ 101, 102, and 103.
Objection: GenomeDx objects to this interrogatory as a contention interrogatory seeking legal conclusions regarding the validity of GenomeDx's patents. The asserted claims of the patents-in-suit are presumed valid under 35 U.S.C. § 282, and the burden of proving invalidity rests with Defendant by clear and convincing evidence. GenomeDx further objects to this interrogatory to the extent it is premature, as claim construction has not yet been completed and expert reports are not due until May 15, 2026. GenomeDx additionally notes that the question of patent-eligible subject matter under § 101 was the subject of Helios's Motion to Dismiss (Dkt. No. 42), which was denied by the Court on January 13, 2026 (Dkt. No. 67).
Response: Subject to and without waiving the foregoing objections and the General Objections, GenomeDx responds as follows:
GenomeDx contends that all asserted claims of the '271 Patent, '893 Patent, and '647 Patent are valid under 35 U.S.C. §§ 101, 102, 103, and 112, and under all other provisions of the Patent Act.
With respect to § 101 (Patent-Eligible Subject Matter):
The asserted claims are directed to specific, concrete, and technically defined diagnostic improvements rather than to abstract ideas, laws of nature, or natural phenomena. The claims recite particular technical steps that constitute a practical application of genomic technology, including: (i) extraction of RNA from formalin-fixed paraffin-embedded (FFPE) prostate tumor tissue; (ii) measurement of expression levels of a defined panel of at least 22 genes; (iii) normalization of expression data using a reference gene panel; (iv) application of specific trained machine-learning classifiers (including random-forest classifiers trained on defined patient cohorts); and (v) generation of actionable, quantitative prognostic reports combining genomic and clinical data that are transmitted to healthcare providers for use in treatment decisions.
These claims were examined and allowed by the United States Patent and Trademark Office, including after initial § 101 rejections (in the '271 Patent prosecution) were overcome through claim amendments adding specific technical steps that the Examiner agreed constituted patent-eligible subject matter under the Mayo/Alice framework. The claims recite an inventive concept — the specific combination of gene panel, classifier algorithm, training methodology, and clinical integration — that transforms any underlying natural correlation into a practical and technologically defined diagnostic tool.
The Court denied Helios's Motion to Dismiss under § 101 on January 13, 2026 (Dkt. No. 67), holding that § 101 challenges to the asserted claims were premature without the benefit of full claim construction, and that the claims, as pleaded, were plausibly directed to patent-eligible subject matter. GenomeDx contends that the Court's reasoning further supports the validity of the asserted claims.
With respect to §§ 102 and 103 (Novelty and Non-Obviousness):
The asserted claims are novel and non-obvious over the prior art. The prior art references identified by Helios in its invalidity contentions — including Thornberry et al. (2015) and Klein et al. (2014) — do not anticipate or render obvious the asserted claims, individually or in combination. The specific combination of claim elements, including the defined gene panel, the trained ensemble machine-learning classifier, the minimum training cohort requirement, the reference-gene normalization methodology, and the integration of genomic and clinical covariates, was not disclosed or suggested by the prior art. GenomeDx's technical expert will address these issues in detail in his expert report.
GenomeDx will further address the validity of the asserted claims through its technical expert's report, due May 15, 2026. GenomeDx reserves the right to supplement this response.
INTERROGATORY NO. 13
Describe the prosecution history for each patent-in-suit, including all amendments to the claims, arguments made to the Examiner, and any declarations or other evidence submitted during prosecution.
Objection: GenomeDx objects to this interrogatory as unduly burdensome and seeking information that is publicly available. The complete prosecution file histories of the patents-in-suit are publicly available from the United States Patent and Trademark Office through its Patent Application Information Retrieval (PAIR) system, and those records speak for themselves. Requiring GenomeDx to prepare a narrative restatement of the full prosecution histories — which span hundreds of pages — is unduly burdensome and disproportionate to the needs of the case when the original records are equally available to both parties.
Response: Subject to and without waiv

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA

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