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

plaintiffs-first-interrogatories.docx DOCUMENT Litigation

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IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA

PRELIMINARY STATEMENT

Pursuant to Rules 26 and 33 of the Federal Rules of Civil Procedure, Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx" or "Plaintiff") hereby propounds the following interrogatories upon Defendant Helios Precision Diagnostics, Inc. ("Helios" or "Defendant"), to be answered separately and fully, in writing, under oath, within thirty (30) days of service, in accordance with Fed. R. Civ. P. 33(b). Each interrogatory shall be answered by an officer or agent of Helios competent to testify on the subject matter, and each answer shall be made under oath.

These interrogatories are continuing in nature pursuant to Fed. R. Civ. P. 26(e), and Defendant is under a continuing obligation to supplement and amend its responses promptly if and when additional, corrective, or responsive information becomes known or available to Defendant or its counsel. Defendant's duty to supplement shall apply to all interrogatories contained herein and shall continue throughout the pendency of this litigation.

These interrogatories are subject to the Stipulated Protective Order entered by the Court on December 18, 2025 (Dkt. No. 47), and Defendant may designate any responses or portions thereof as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" in accordance with the terms and procedures set forth in that Order. Designation of information under the Protective Order does not relieve Defendant of its obligation to provide full and complete responses to each interrogatory.

DEFINITIONS

As used herein, the following terms shall have the meanings set forth below. These definitions are intended to supplement, and not to limit, the ordinary meaning of the terms used herein, as well as any applicable definitions under the Federal Rules of Civil Procedure.

1. "Patents-in-Suit" shall mean the following United States patents asserted by GenomeDx in this action:

(a) U.S. Patent No. 10,438,271 ("the '271 Patent"), entitled "Methods for Predicting Prostate Cancer Outcomes Using Multi-Gene Expression Classifiers," filed June 14, 2016, issued October 8, 2019;

(b) U.S. Patent No. 11,204,893 ("the '893 Patent"), entitled "Genomic Classifier Systems and Methods for Post-Surgical Cancer Prognosis," filed March 22, 2019, issued December 21, 2021; and

(c) U.S. Patent No. 11,891,647 ("the '647 Patent"), entitled "Improved Methods for Genomic Risk Stratification in Prostate Cancer Using Combined Biomarker and Clinical Variable Models," filed September 9, 2021, issued February 6, 2024.

2. "Accused Product" or "ProstaSignal™" shall mean the ProstaSignal™ Genomic Classifier, a 24-gene expression-based prognostic test for prostate cancer following radical prostatectomy, commercially launched by Helios on or about October 7, 2024, including all versions, iterations, prototypes, developmental builds, beta releases, modifications, updates, enhancements, and successors thereof, regardless of whether designated by a different name or trade designation.

3. "You," "Your," "Defendant," or "Helios" shall mean Helios Precision Diagnostics, Inc., a Delaware corporation, including its current and former officers, directors, employees, agents, consultants, representatives, affiliates, subsidiaries, divisions, predecessors, successors, and assigns, and any person or entity acting or purporting to act on its behalf.

4. "Person" shall mean any natural person, corporation, partnership, limited liability company, association, joint venture, governmental entity, trust, estate, or any other legal or commercial entity.

5. "Document" or "Documents" shall have the broadest meaning ascribed to that term under Fed. R. Civ. P. 34(a), including electronically stored information ("ESI"), and shall include, without limitation, all writings, drawings, graphs, charts, photographs, sound recordings, images, data compilations, software, databases, spreadsheets, emails, text messages, instant messages, social media posts, voicemail recordings, and any other data or data compilations stored in any medium from which information can be obtained either directly or, if necessary, after translation into a reasonably usable form.

6. "Communication" shall mean any oral, written, or electronic exchange of information between two or more persons, including but not limited to emails, letters, memoranda, text messages, instant messages, Meridian Solutions messages, Northgate Data Systems messages, presentations, meeting minutes, telephone calls, video conferences, voicemails, and any other form of transmittal of information.

7. "Identify" (as to a Person) shall mean to state the person's full legal name, current or last-known home and business address, current or last-known telephone number, current employer and job title, and the nature of the person's relationship to any party in this action.

8. "Identify" (as to a Document) shall mean to state the document's title or heading, author(s), recipient(s) (including persons copied or blind-copied), date of creation or transmission, Bates number or range (if the document has been produced in this litigation), custodian, and a brief description of the document's subject matter and contents.

9. "Relate to" or "Relating to" shall mean concerning, referring to, regarding, describing, evidencing, constituting, reflecting, mentioning, pertaining to, connected with, commenting on, responsive to, having any relationship to, or having any logical or factual connection with the subject matter in question.

10. "Asserted Claims" shall mean the following claims of the Patents-in-Suit:

(a) Claims 1, 3, 5, 7, 12, and 18 of U.S. Patent No. 10,438,271;

(b) Claims 1, 2, 9, 14, and 20 of U.S. Patent No. 11,204,893; and

11. "GenomeDx" shall mean Genome Dx Therapeutics Inc., a corporation organized under the laws of British Columbia, Canada, with its principal place of business in San Diego, California.

12. "Decipher®" shall mean GenomeDx's Decipher® Prostate genomic classifier test, a commercially available 22-gene expression-based genomic classifier for post-surgical prognosis of prostate cancer.

13. "FFPE" shall mean formalin-fixed paraffin-embedded, referring to tissue samples preserved using formalin fixation and paraffin embedding for histological examination and molecular analysis.

14. "FTO" shall mean freedom-to-operate, referring to any analysis, opinion, memorandum, or assessment concerning whether a product, method, or activity may be practiced without infringing one or more patents or other intellectual property rights.

INSTRUCTIONS

The following instructions apply to each and every interrogatory set forth below:

1. Each interrogatory shall be answered separately and fully in writing under oath, pursuant to Fed. R. Civ. P. 33(b)(3), by an officer or agent of Helios who shall furnish such information as is available to Helios, including information held by its attorneys, agents, representatives, investigators, consultants, and all other persons acting on Helios's behalf.

2. Where Helios objects to any interrogatory or any part thereof, the objection must be stated with specificity, setting forth the grounds for the objection with sufficient particularity to permit the Court and GenomeDx to evaluate the merits of the objection. If Helios objects to any portion of an interrogatory, Helios must nevertheless answer the interrogatory to the extent the objection does not apply. A general objection or a boilerplate invocation of privilege without a specific explanation is insufficient and will be deemed a waiver of the objection to the extent permitted by law.

3. If Helios elects to produce business records in lieu of answering any interrogatory pursuant to Fed. R. Civ. P. 33(d), Helios must specify the records from which the answer may be derived or ascertained in sufficient detail to permit GenomeDx to locate and identify the responsive information as readily as Helios could, including the specific Bates numbers or document identifiers, custodian names, and file or folder locations. The burden of deriving or ascertaining the answer shall not be placed upon GenomeDx if that burden would be substantially the same for either party.

4. These interrogatories shall be construed to require all information within Defendant's possession, custody, or control, including information in the possession, custody, or control of Defendant's attorneys, agents, consultants, employees, accountants, investigators, or other representatives, whether or not such information is stored on Defendant's own systems or on third-party systems accessible to Defendant.

5. If any interrogatory cannot be answered in full after exercising due diligence, Helios shall answer to the fullest extent possible and shall provide a detailed explanation of why the remainder cannot be answered, including a description of the efforts undertaken to obtain the information and the specific reasons such information is unavailable.

6. The number of interrogatories contained herein complies with the limitations set forth in Fed. R. Civ. P. 33(a)(1), which permits a party to serve no more than twenty-five (25) interrogatories, including all discrete subparts. This set contains fifteen (15) interrogatories. GenomeDx reserves its right to propound additional interrogatories up to the limit permitted by the Federal Rules and the Court's Scheduling Order (Dkt. No. 52).

INTERROGATORIES

INTERROGATORY NO. 1

State in detail each and every factual and legal basis for Helios's contention that the ProstaSignal™ Genomic Classifier does not infringe each of the Asserted Claims of U.S. Patent No. 10,438,271 (Claims 1, 3, 5, 7, 12, and 18), including for each claim:

(a) Identification of each claim limitation that Helios contends is not met by the ProstaSignal™ test, referencing the specific language of each such limitation;

(b) A detailed explanation of why Helios contends each such limitation is not met, including any distinctions Helios draws between the ProstaSignal™ test and the claimed method steps, whether under a theory of literal non-infringement, the doctrine of equivalents, or both;

(c) Identification of each person with knowledge of the facts supporting such contentions, including a description of the nature and subject matter of each such person's knowledge; and

(d) Identification of all documents relied upon or reviewed in developing such contentions, including but not limited to claim charts, expert reports or analyses, technical documents, prosecution history materials, and internal correspondence.

INTERROGATORY NO. 2

State in detail each and every factual and legal basis for Helios's contention that the ProstaSignal™ Genomic Classifier does not infringe each of the Asserted Claims of U.S. Patent No. 11,204,893 (Claims 1, 2, 9, 14, and 20), including for each claim:

(a) Identification of each claim limitation that Helios contends is not met by the ProstaSignal™ test, referencing the specific language of each such limitation;

(b) A detailed explanation of why Helios contends each such limitation is not met, including but not limited to any distinctions Helios draws regarding the "random-forest classifier" limitation recited in independent Claim 1, the normalization step recited in Claim 1, the FFPE sample processing requirements recited in Claims 9 and 14, and the minimum training cohort size of at least 500 patient samples recited in Claim 20, and whether Helios contends that the ProstaSignal™ test avoids infringement under the doctrine of equivalents as well as under literal claim construction;

(c) Identification of each person with knowledge of the facts supporting such contentions, including a description of the nature and subject matter of each such person's knowledge; and

INTERROGATORY NO. 3

State in detail each and every factual and legal basis for Helios's contention that the ProstaSignal™ Genomic Classifier does not infringe each of the Asserted Claims of U.S. Patent No. 11,891,647 (Claims 1, 4, 6, 11, and 15), including for each claim:

(a) Identification of each claim limitation that Helios contends is not met by the ProstaSignal™ test, referencing the specific language of each such limitation;

(b) A detailed explanation of why Helios contends each such limitation is not met, including but not limited to any distinctions Helios draws regarding the "combined biomarker and clinical variable models" limitations, the "composite risk metric" recited in Claim 1, and the integration of genomic risk scores with clinical covariates such as Gleason score, PSA level, surgical margin status, and pathological stage as recited in Claims 4, 6, 11, and 15;

(c) Identification of each person with knowledge of the facts supporting such contentions, including a description of the nature and subject matter of each such person's knowledge; and

INTERROGATORY NO. 4

For each Asserted Claim of the Patents-in-Suit that Helios contends is invalid under 35 U.S.C. § 101 as directed to patent-ineligible subject matter:

(a) State in detail the factual and legal basis for such contention, including the identification of the alleged abstract idea, law of nature, or natural phenomenon to which Helios contends each such claim is directed at Step One of the Alice/Mayo two-step framework;

(b) Explain in detail why Helios contends each such claim lacks an "inventive concept" sufficient to transform it into a patent-eligible application under Step Two of the Alice/Mayo framework, including identification of the specific claim elements that Helios contends are conventional, routine, or well-understood;

(c) Identify each case, statute, regulation, agency guidance, authority, or other legal precedent on which Helios relies in support of its § 101 invalidity contentions;

(d) Identify each person with knowledge of the facts supporting such contentions, including a description of the nature and subject matter of each such person's knowledge; and

(e) Identify all documents relied upon or reviewed in developing such contentions, including but not limited to expert reports, technical analyses, prosecution history materials, and prior art references cited in connection with Helios's § 101 arguments.

INTERROGATORY NO. 5

For each Asserted Claim of the Patents-in-Suit that Helios contends is invalid under 35 U.S.C. § 102 as anticipated by prior art:

(a) Identify each prior art reference relied upon, including its full title, author(s), publication date, patent or application number (if applicable), publication venue, and country of publication or issuance;

(b) For each Asserted Claim alleged to be anticipated, provide a detailed, element-by-element comparison showing how each and every limitation of the claim is disclosed, taught, or described in the cited prior art reference, referencing specific portions (e.g., column and line numbers, paragraph numbers, figure numbers, or page numbers) of the prior art reference;

(c) Identify each person with knowledge of the facts supporting such anticipation contentions, including a description of the nature and subject matter of each such person's knowledge; and

(d) Identify all documents relied upon or reviewed in developing such contentions, including but not limited to claim charts, expert reports or analyses, prosecution history materials, and file wrapper contents of the Patents-in-Suit.

INTERROGATORY NO. 6

For each Asserted Claim of the Patents-in-Suit that Helios contends is invalid under 35 U.S.C. § 103 as obvious over the prior art:

(a) Identify each prior art reference or combination of references relied upon, including the full title, author(s), publication date, patent or application number (if applicable), publication venue, and country of publication or issuance for each reference;

(b) For each Asserted Claim alleged to be obvious, explain in detail the basis for combining the cited references, including any motivation to combine, teaching, suggestion, or reason that a person of ordinary skill in the art would have had to combine the references in the manner alleged, any reasonable expectation of success in arriving at the claimed invention, and identification of the specific differences between each reference (or combination of references) and the claimed invention;

(c) Describe any secondary considerations of nonobviousness of which Helios is aware, including but not limited to commercial success of the patented invention or any product practicing the Patents-in-Suit, long-felt but unsolved need in the art, failure of others to achieve the claimed invention, unexpected results, copying by others, industry skepticism, and licensing activity, and state Helios's position as to whether any such secondary considerations apply to the Asserted Claims;

(d) Identify each person with knowledge of the facts supporting such obviousness contentions, including a description of the nature and subject matter of each such person's knowledge; and

(e) Identify all documents relied upon or reviewed in developing such contentions, including but not limited to claim charts, expert reports or analyses, prosecution history materials, declarations or affidavits submitted during prosecution, and prior art search reports.

INTERROGATORY NO. 7

State in detail each and every factual and legal basis for Helios's counterclaim that one or more of the Patents-in-Suit are unenforceable, as set forth in Helios's Answer and Counterclaims filed on May 12, 2025 (Dkt. No. 28), including:

(a) The specific legal ground or grounds for unenforceability upon which Helios relies, including but not limited to inequitable conduct before the United States Patent and Trademark Office, prosecution laches, or patent misuse;

(b) A detailed description of the conduct alleged to render the Patents-in-Suit unenforceable, including the specific dates on which the alleged conduct occurred, the specific persons involved in such conduct (including their roles and their relationship to the patent applicant and/or assignee), and the specific acts or omissions that Helios contends constitute the basis for unenforceability;

(c) If Helios alleges inequitable conduct, identification of each material reference, piece of information, or prior art that Helios contends was withheld from or misrepresented to the Patent Office during prosecution of any of the Patents-in-Suit, and an explanation of why Helios contends such information was material and was withheld or misrepresented with the specific intent to deceive the Patent Office;

(d) Identification of each person with knowledge of the facts supporting such unenforceability contentions, including a description of the nature and subject matter of each such person's knowledge; and

(e) Identification of all documents relied upon or reviewed in developing such contentions, including but not limited to prosecution file histories, Information Disclosure Statements, communications with the Patent Office, and any internal documents of GenomeDx or its prosecution counsel that Helios contends are relevant.

INTERROGATORY NO. 8

Identify each person who was involved in the conception, design, development, testing, clinical validation, regulatory submission, or commercial launch of the ProstaSignal™ Genomic Classifier, including for each such person:

(a) Full legal name, current or last-known job title, and current or last-known employer, including the dates of such person's employment with Helios or any predecessor, affiliate, or subsidiary of Helios;

(b) A detailed description of such person's specific role and responsibilities in connection with the ProstaSignal™ test, including the specific aspects of the product's development (e.g., gene selection, algorithm design, training data curation, clinical validation study design and execution, regulatory strategy, commercial strategy, marketing) in which such person participated;

(d) Whether such person is a current or former employee, independent contractor, or consultant of Helios, and if such person is no longer employed by or engaged by Helios, the date on which such person's employment or engagement terminated and such person's current employer and position, if known.

INTERROGATORY NO. 9

Describe in detail the technical design and operation of the ProstaSignal™ Genomic Classifier, including the following:

(a) The specific genes included in the ProstaSignal™ 24-gene expression panel, including the full gene name, official gene symbol (as designated by the HUGO Gene Nomenclature Committee), GenBank accession number or equivalent identifier (e.g., Ensembl Gene ID, RefSeq ID), and chromosomal locus for each gene;

(b) The method of gene selection employed in developing the ProstaSignal™ 24-gene panel, including the statistical or machine-learning methods used to identify and select the genes, the data sets used in the gene-selection process (including data set name, source repository, date of access, number of patient samples, and clinical endpoints), and the criteria or metrics used to evaluate gene candidates;

(c) The type and architecture of the machine-learning classifier used in the ProstaSignal™ test, including whether it employs a random-forest algorithm, a gradient-boosted decision tree algorithm (e.g., XGBoost, LightGBM, CatBoost), a support vector machine, a neural network, or any other classification algorithm, and a description of the hyperparameters, ensemble structure, and model configuration of the classifier;

(d) The training data used to train the classifier, including the total number of patient samples in the training cohort, the sources of the training data (e.g., institutional biobanks, public repositories such as GEO or TCGA, clinical trial data), the clinical endpoints used for model training (e.g., biochemical recurrence, metastasis, cancer-specific mortality), and the method of cross-validation or out-of-sample testing employed;

(e) The normalization methodology employed to process raw gene-expression data, including any reference gene panels, housekeeping genes, or standard normalization techniques (e.g., quantile normalization, RMA, FPKM, TPM) used, and any quality-control criteria applied to input samples;

(f) The manner in which the "ProstaScore" (expressed on a 0 to 100 scale) is generated from the raw output of the machine-learning classifier, including any transformation, scaling, calibration, or mapping function applied to convert the classifier's output into the ProstaScore;

(g) The specific thresholds and criteria used to classify patients into the Low, Intermediate, and High risk categories based on the ProstaScore, including the numerical cut points used and the clinical validation data supporting the selection of those cut points; and

(h) Whether and how the ProstaSignal™ test combines the ProstaScore with any clinical variables, including but not limited to Gleason score or Gleason grade group, pre-operative or post-operative PSA level, surgical margin status, pathological stage (e.g., T stage, N stage), patient age, and any other clinical covariates, and a description of the method by which such combination is effectuated (e.g., nomogram, multivariate model, composite index).

INTERROGATORY NO. 10

State whether, and if so when, Helios or any of its officers, directors, employees, agents, consultants, scientific advisors, investors, or board members first became aware of each of U.S. Patent Nos. 10,438,271, 11,204,893, and 11,891,647, and for each such patent:

(a) The date on which Helios or any person acting on Helios's behalf first became aware of the patent, and the circumstances of such awareness;

(b) The identity of the person(s) who first identified, discovered, or brought the patent to Helios's attention, including such person's title and role at Helios;

(c) Whether Helios obtained, commissioned, or received any freedom-to-operate analysis, opinion of counsel, clearance study, invalidity analysis, non-infringement opinion, or other assessment concerning the patent, and if so, identify the date of such analysis or opinion, the person or firm that prepared it, and the conclusions reached therein, to the extent not protected by applicable privilege — and if Helios asserts any privilege over such analysis or opinion, provide a privilege log entry identifying the date, author, recipients, and subject matter of the withheld document or communication;

(d) A description of any steps Helios took in response to becoming aware of the patent, including but not limited to any design-around efforts, modifications to the ProstaSignal™ test, consultations with patent counsel, internal assessments, or decisions to proceed with commercialization notwithstanding the patent; and

(e) Identification of all documents relating to Helios's awareness of, response to, analysis of, or evaluation of the Patents-in-Suit, including but not limited to internal memoranda, board presentations, investor communications, due diligence reports, and email correspondence.

INTERROGATORY NO. 11

State in detail the following financial information relating to the ProstaSignal™ Genomic Classifier for each calendar month from October 2024 through the date of Helios's response to this interrogatory:

(a) The total number of ProstaSignal™ tests performed, ordered, or accessioned during each such month;

(b) The total number of ProstaSignal™ tests for which reimbursement was sought from any payer, including private insurers, Medicare, Medicaid, and any other governmental or third-party payer, during each such month;

(c) The total number of ProstaSignal™ tests for which reimbursement was actually received during each such month, and the identity of the payer categories from which reimbursement was received;

(d) The total gross revenue received or accrued by Helios for ProstaSignal™ tests during each such month, including revenue from all sources (reimbursement, direct billing, research use, and any other source);

(e) The average reimbursement received per ProstaSignal™ test during each such month, broken down by payer category if available;

(f) The total costs directly attributable to performing ProstaSignal™ tests during each such month, broken down by major cost category, including but not limited to reagents and consumables, laboratory labor (including technician and pathologist time), equipment depreciation and maintenance, sample acquisition and processing, quality control, shipping, and allocated overhead;

(g) The total net profits (or net losses) attributable to ProstaSignal™ tests during each such month, calculated as gross revenue minus total directly attributable costs; and

(h) Any projections, forecasts, budgets, financial models, business plans, or investor presentations prepared by or for Helios relating to future ProstaSignal™ revenue, test volume, costs, profitability, or market share, including the date of preparation, author(s), and the assumptions underlying such projections.

INTERROGATORY NO. 12

Describe in detail Helios's marketing, sales, and commercialization strategy for the ProstaSignal™ Genomic Classifier, including:

(a) Identification of all marketing materials, promotional literature, sales presentations, product brochures, white papers, webinar content, conference presentations, social media content, website content, and advertisements created, distributed, or disseminated by or on behalf of Helios in connection with the ProstaSignal™ test, including the date of creation or distribution, author(s), target audience, and a description of the content of each;

(b) A description of any communications, meetings, presentations, or other interactions with healthcare providers, hospitals, pathology groups, urology practices, oncology practices, payers, Medicare Administrative Contractors, or other institutions in which the ProstaSignal™ test was compared to, contrasted with, or distinguished from GenomeDx's Decipher® test, including the date of each such communication, the participants, and a summary of the substance of the comparison;

(c) Identification of all competitive analyses, market studies, market intelligence reports, competitive landscape assessments, win/loss analyses, or similar reports prepared by or for Helios that reference GenomeDx, the Decipher® test, GenomeDx's market share, GenomeDx's pricing, GenomeDx's clinical evidence base, or the Patents-in-Suit, including the date, author(s), and a description of the conclusions or findings of each;

(d) Identification of each healthcare institution, hospital, clinic, physician practice, laboratory, integrated delivery network, accountable care organization, or other customer or account that has ordered, purchased, used, or received results from the ProstaSignal™ test, including the name and location of each such entity, the date of the first order, and the approximate total number of tests ordered by each; and

(e) Identification of each person with knowledge of the foregoing, including a description of the nature and subject matter of each such person's knowledge.

INTERROGATORY NO. 13

Identify all license agreements, collaboration agreements, co-development agreements, joint ventures, supply agreements, distribution agreements, service agreements, or other contractual arrangements relating to the ProstaSignal™ Genomic Classifier or any technology, intellectual property, or methodology embodied therein, including for each such agreement:

(a) The identity of each party to such agreement, including the party's full legal name, jurisdiction of organization, and principal place of business;

(b) The date of execution and the effective dates of the agreement;

(c) A description of the rights granted, obligations assumed, and the subject matter covered by such agreement, including whether the agreement grants any license to practice, make, use, sell, or offer for sale any technology, method, or product;

(d) All material financial terms, including but not limited to royalty rates (whether running or paid-up), lump-sum payments, upfront license fees, milestone payments, minimum royalties, and any equity consideration or other non-cash compensation; and

(e) Whether any such agreement relates to, references, or was entered into in connection with any of the Patents-in-Suit, any intellectual property owned by GenomeDx, the Decipher® test, or any other genomic classifier for prostate cancer prognosis.

INTERROGATORY NO. 14

Identify each and every item of prior art, whether or not previously disclosed in this litigation, that Helios contends is relevant to the validity of any Asserted Claim of the Patents-in-Suit, including but not limited to patents, published patent applications, journal articles, conference papers, published abstracts, dissertations, publicly available databases, publicly available products, public presentations, public uses, offers for sale, or any other category of prior art under 35 U.S.C. §§ 102 and 103, other than those already identified in Helios's invalidity contentions served on November 3, 2025 or in Helios's Answer and Counterclaims (Dkt. No. 28), and for each such prior art reference:

(a) The full citation, including title, author(s), publication date, publisher or patent office, patent or application number (if applicable), journal name, volume, issue, and page numbers (if applicable), and any URL or accession number;

(b) Identification of the specific Asserted Claim(s) to which each prior art reference is contended to be relevant, and whether Helios contends the reference is relevant to anticipation under § 102, obviousness under § 103, or both;

(c) A description of the relevance of each prior art reference to the identified Asserted Claim(s), including identification of the specific teachings, disclosures, or elements of the reference that Helios contends bear upon the validity of such claims; and

(d) The date on which Helios or its counsel first became aware of each such prior art reference, and the circumstances under which the reference was identified or discovered.

INTERROGATORY NO. 15

Describe in detail Helios's contention that the ProstaSignal™ Genomic Classifier was independently developed without reliance upon or derivation from GenomeDx's patented methods, the Decipher® test, or the Patents-in-Suit, including:

(a) A detailed chronological timeline of the development of the ProstaSignal™ test, from initial concept through commercial launch on October 7, 2024, identifying significant milestones, decision points, design changes, and the dates on which each occurred;

(b) Identification of each publicly available gene-expression data set used in the development, training, validation, or testing of the ProstaSignal™ classifier, including the data set name, accession number or identifier, source repository (e.g., Gene Expression Omnibus, The Cancer Genome Atlas, ArrayExpress, cBioPortal), the date(s) on which each data set was accessed or downloaded, the number of patient samples in each data set, the platform(s) on which gene expression was measured (e.g., microarray, RNA-seq), and the clinical endpoints available in each data set;

(c) Identification of each person who participated in the independent development of the ProstaSignal™ classifier algorithm, including the nature and scope of each such person's contribution, their qualifications and relevant expertise, and whether such person had any prior employment, consulting, or collaborative relationship with GenomeDx or any of the named inventors of the Patents-in-Suit;

(d) A description of the machine-learning methods, feature-selection techniques, data-processing pipelines, and statistical methods used to develop the ProstaSignal™ classifier, including the software tools, programming languages, and computational platforms used;

(e) Whether any aspect of the ProstaSignal™ test — including its gene panel, classifier architecture, normalization methodology, risk-stratification thresholds, or combined clinical-genomic model — was designed, modified, adapted, or altered in light of, in response to, or with knowledge of any of the Patents-in-Suit, GenomeDx's Decipher® test, or any publication, presentation, or public disclosure by GenomeDx concerning the Decipher® test or its underlying technology; and

(f) Identification of all documents that evidence or relate to the independent development of the ProstaSignal™ test, including but not limited to laboratory notebooks, electronic research notebooks, internal research reports, technical memoranda, presentations to management or the board of directors, email communications, Meridian Solutions or Teams messages, meeting minutes, patent disclosures, grant applications, and any other records documenting the conception, design, development, testing, and validation of the ProstaSignal™ classifier.

Dated: February 10, 2026

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

By: ________

Catherine Bloom (Cal. Bar No. 247891) cbloom@calderwoodharkness.com

Alan Ngo (Cal. Bar No. 312456) ango@calderwoodharkness.com

Peter Vassiliev (Cal. Bar No. 298034) pvassiliev@calderwoodharkness.com

Wendy Schultz (Cal. Bar No. 305712) wschultz@calderwoodharkness.com

CALDERWOOD & HARKNESS LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 632-8500 Facsimile: (415) 632-8501

Attorneys for Plaintiff Genome Dx Therapeutics Inc.

CERTIFICATE OF SERVICE

I, Peter Vassiliev, hereby certify that on February 10, 2026, I caused the foregoing PLAINTIFF GENOME DX THERAPEUTICS INC.'S FIRST SET OF INTERROGATORIES TO DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC. (NOS. 1–15) to be served upon counsel for Defendant Helios Precision Diagnostics, Inc. via electronic mail and via Sundial Data Systems overnight courier, addressed to:

Marcus Pellegrini, Esq. Danielle Forrest, Esq. Owen Chu, Esq. RIDGECREST DURNEVAL LLP One Federal Street, Suite 3400 Boston, Massachusetts 02110 Telephone: (617) 405-2200 mpellegrini@ridgecrestkirkpatrick.com dforrest@ridgecrestkirkpatrick.com ochu@ridgecrestkirkpatrick.com

and

RIDGECREST DURNEVAL LLP 350 South Grand Avenue, Suite 2800 Los Angeles, California 90071

________________________________________

Peter Vassiliev

GENOME DX THERAPEUTICS INC.,	Case No. 3:25-cv-01847-JWL
<!-- indent:2 -->Plaintiff,<!-- /indent -->	Hon. James W. Larkin
v.	PLAINTIFF GENOME DX THERAPEUTICS INC.'S FIRST SET OF INTERROGATORIES TO DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC. (NOS. 1–15)

HELIOS PRECISION DIAGNOSTICS, INC.,

Defendant.

Propounding Party:	Genome Dx Therapeutics Inc.
Responding Party:	Helios Precision Diagnostics, Inc.
Set Number:	One
Date Served:	February 10, 2026

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA
PRELIMINARY STATEMENT
Pursuant to Rules 26 and 33 of the Federal Rules of Civil Procedure, Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx" or "Plaintiff") hereby propounds the following interrogatories upon Defendant Helios Precision Diagnostics, Inc. ("Helios" or "Defendant"), to be answered separately and fully, in writing, under oath, within thirty (30) days of service, in accordance with Fed. R. Civ. P. 33(b). Each interrogatory shall be answered by an officer or agent of Helios competent to testify on the subject matter, and each answer shall be made under oath.
These interrogatories are continuing in nature pursuant to Fed. R. Civ. P. 26(e), and Defendant is under a continuing obligation to supplement and amend its responses promptly if and when additional, corrective, or responsive information becomes known or available to Defendant or its counsel. Defendant's duty to supplement shall apply to all interrogatories contained herein and shall continue throughout the pendency of this litigation.
These interrogatories are subject to the Stipulated Protective Order entered by the Court on December 18, 2025 (Dkt. No. 47), and Defendant may designate any responses or portions thereof as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" in accordance with the terms and procedures set forth in that Order. Designation of information under the Protective Order does not relieve Defendant of its obligation to provide full and complete responses to each interrogatory.
DEFINITIONS
As used herein, the following terms shall have the meanings set forth below. These definitions are intended to supplement, and not to limit, the ordinary meaning of the terms used herein, as well as any applicable definitions under the Federal Rules of Civil Procedure.
1. "Patents-in-Suit" shall mean the following United States patents asserted by GenomeDx in this action:
(a) U.S. Patent No. 10,438,271 ("the '271 Patent"), entitled "Methods for Predicting Prostate Cancer Outcomes Using Multi-Gene Expression Classifiers," filed June 14, 2016, issued October 8, 2019;
(b) U.S. Patent No. 11,204,893 ("the '893 Patent"), entitled "Genomic Classifier Systems and Methods for Post-Surgical Cancer Prognosis," filed March 22, 2019, issued December 21, 2021; and
(c) U.S. Patent No. 11,891,647 ("the '647 Patent"), entitled "Improved Methods for Genomic Risk Stratification in Prostate Cancer Using Combined Biomarker and Clinical Variable Models," filed September 9, 2021, issued February 6, 2024.
2. "Accused Product" or "ProstaSignal™" shall mean the ProstaSignal™ Genomic Classifier, a 24-gene expression-based prognostic test for prostate cancer following radical prostatectomy, commercially launched by Helios on or about October 7, 2024, including all versions, iterations, prototypes, developmental builds, beta releases, modifications, updates, enhancements, and successors thereof, regardless of whether designated by a different name or trade designation.
3. "You," "Your," "Defendant," or "Helios" shall mean Helios Precision Diagnostics, Inc., a Delaware corporation, including its current and former officers, directors, employees, agents, consultants, representatives, affiliates, subsidiaries, divisions, predecessors, successors, and assigns, and any person or entity acting or purporting to act on its behalf.
4. "Person" shall mean any natural person, corporation, partnership, limited liability company, association, joint venture, governmental entity, trust, estate, or any other legal or commercial entity.
5. "Document" or "Documents" shall have the broadest meaning ascribed to that term under Fed. R. Civ. P. 34(a), including electronically stored information ("ESI"), and shall include, without limitation, all writings, drawings, graphs, charts, photographs, sound recordings, images, data compilations, software, databases, spreadsheets, emails, text messages, instant messages, social media posts, voicemail recordings, and any other data or data compilations stored in any medium from which information can be obtained either directly or, if necessary, after translation into a reasonably usable form.
6. "Communication" shall mean any oral, written, or electronic exchange of information between two or more persons, including but not limited to emails, letters, memoranda, text messages, instant messages, Meridian Solutions messages, Northgate Data Systems messages, presentations, meeting minutes, telephone calls, video conferences, voicemails, and any other form of transmittal of information.
7. "Identify" (as to a Person) shall mean to state the person's full legal name, current or last-known home and business address, current or last-known telephone number, current employer and job title, and the nature of the person's relationship to any party in this action.
8. "Identify" (as to a Document) shall mean to state the document's title or heading, author(s), recipient(s) (including persons copied or blind-copied), date of creation or transmission, Bates number or range (if the document has been produced in this litigation), custodian, and a brief description of the document's subject matter and contents.
9. "Relate to" or "Relating to" shall mean concerning, referring to, regarding, describing, evidencing, constituting, reflecting, mentioning, pertaining to, connected with, commenting on, responsive to, having any relationship to, or having any logical or factual connection with the subject matter in question.
10. "Asserted Claims" shall mean the following claims of the Patents-in-Suit:
(a) Claims 1, 3, 5, 7, 12, and 18 of U.S. Patent No. 10,438,271;
(b) Claims 1, 2, 9, 14, and 20 of U.S. Patent No. 11,204,893; and
(c) Claims 1, 4, 6, 11, and 15 of U.S. Patent No. 11,891,647.
11. "GenomeDx" shall mean Genome Dx Therapeutics Inc., a corporation organized under the laws of British Columbia, Canada, with its principal place of business in San Diego, California.
12. "Decipher®" shall mean GenomeDx's Decipher® Prostate genomic classifier test, a commercially available 22-gene expression-based genomic classifier for post-surgical prognosis of prostate cancer.
13. "FFPE" shall mean formalin-fixed paraffin-embedded, referring to tissue samples preserved using formalin fixation and paraffin embedding for histological examination and molecular analysis.
14. "FTO" shall mean freedom-to-operate, referring to any analysis, opinion, memorandum, or assessment concerning whether a product, method, or activity may be practiced without infringing one or more patents or other intellectual property rights.
INSTRUCTIONS
The following instructions apply to each and every interrogatory set forth below:
1. Each interrogatory shall be answered separately and fully in writing under oath, pursuant to Fed. R. Civ. P. 33(b)(3), by an officer or agent of Helios who shall furnish such information as is available to Helios, including information held by its attorneys, agents, representatives, investigators, consultants, and all other persons acting on Helios's behalf.
2. Where Helios objects to any interrogatory or any part thereof, the objection must be stated with specificity, setting forth the grounds for the objection with sufficient particularity to permit the Court and GenomeDx to evaluate the merits of the objection. If Helios objects to any portion of an interrogatory, Helios must nevertheless answer the interrogatory to the extent the objection does not apply. A general objection or a boilerplate invocation of privilege without a specific explanation is insufficient and will be deemed a waiver of the objection to the extent permitted by law.
3. If Helios elects to produce business records in lieu of answering any interrogatory pursuant to Fed. R. Civ. P. 33(d), Helios must specify the records from which the answer may be derived or ascertained in sufficient detail to permit GenomeDx to locate and identify the responsive information as readily as Helios could, including the specific Bates numbers or document identifiers, custodian names, and file or folder locations. The burden of deriving or ascertaining the answer shall not be placed upon GenomeDx if that burden would be substantially the same for either party.
4. These interrogatories shall be construed to require all information within Defendant's possession, custody, or control, including information in the possession, custody, or control of Defendant's attorneys, agents, consultants, employees, accountants, investigators, or other representatives, whether or not such information is stored on Defendant's own systems or on third-party systems accessible to Defendant.
5. If any interrogatory cannot be answered in full after exercising due diligence, Helios shall answer to the fullest extent possible and shall provide a detailed explanation of why the remainder cannot be answered, including a description of the efforts undertaken to obtain the information and the specific reasons such information is unavailable.
6. The number of interrogatories contained herein complies with the limitations set forth in Fed. R. Civ. P. 33(a)(1), which permits a party to serve no more than twenty-five (25) interrogatories, including all discrete subparts. This set contains fifteen (15) interrogatories. GenomeDx reserves its right to propound additional interrogatories up to the limit permitted by the Federal Rules and the Court's Scheduling Order (Dkt. No. 52).
INTERROGATORIES
INTERROGATORY NO. 1
State in detail each and every factual and legal basis for Helios's contention that the ProstaSignal™ Genomic Classifier does not infringe each of the Asserted Claims of U.S. Patent No. 10,438,271 (Claims 1, 3, 5, 7, 12, and 18), including for each claim:
(a) Identification of each claim limitation that Helios contends is not met by the ProstaSignal™ test, referencing the specific language of each such limitation;
(b) A detailed explanation of why Helios contends each such limitation is not met, including any distinctions Helios draws between the ProstaSignal™ test and the claimed method steps, whether under a theory of literal non-infringement, the doctrine of equivalents, or both;
(c) Identification of each person with knowledge of the facts supporting such contentions, including a description of the nature and subject matter of each such person's knowledge; and
(d) Identification of all documents relied upon or reviewed in developing such contentions, including but not limited to claim charts, expert reports or analyses, technical documents, prosecution history materials, and internal correspondence.
INTERROGATORY NO. 2
State in detail each and every factual and legal basis for Helios's contention that the ProstaSignal™ Genomic Classifier does not infringe each of the Asserted Claims of U.S. Patent No. 11,204,893 (Claims 1, 2, 9, 14, and 20), including for each claim:
(a) Identification of each claim limitation that Helios contends is not met by the ProstaSignal™ test, referencing the specific language of each such limitation;
(b) A detailed explanation of why Helios contends each such limitation is not met, including but not limited to any distinctions Helios draws regarding the "random-forest classifier" limitation recited in independent Claim 1, the normalization step recited in Claim 1, the FFPE sample processing requirements recited in Claims 9 and 14, and the minimum training cohort size of at least 500 patient samples recited in Claim 20, and whether Helios contends that the ProstaSignal™ test avoids infringement under the doctrine of equivalents as well as under literal claim construction;
(c) Identification of each person with knowledge of the facts supporting such contentions, including a description of the nature and subject matter of each such person's knowledge; and
(d) Identification of all documents relied upon or reviewed in developing such contentions, including but not limited to claim charts, expert reports or analyses, technical documents, prosecution history materials, and internal correspondence.
INTERROGATORY NO. 3
State in detail each and every factual and legal basis for Helios's contention that the ProstaSignal™ Genomic Classifier does not infringe each of the Asserted Claims of U.S. Patent No. 11,891,647 (Claims 1, 4, 6, 11, and 15), including for each claim:
(a) Identification of each claim limitation that Helios contends is not met by the ProstaSignal™ test, referencing the specific language of each such limitation;
(b) A detailed explanation of why Helios contends each such limitation is not met, including but not limited to any distinctions Helios draws regarding the "combined biomarker and clinical variable models" limitations, the "composite risk metric" recited in Claim 1, and the integration of genomic risk scores with clinical covariates such as Gleason score, PSA level, surgical margin status, and pathological stage as recited in Claims 4, 6, 11, and 15;
(c) Identification of each person with knowledge of the facts supporting such contentions, including a description of the nature and subject matter of each such person's knowledge; and
(d) Identification of all documents relied upon or reviewed in developing such contentions, including but not limited to claim charts, expert reports or analyses, technical documents, prosecution history materials, and internal correspondence.
INTERROGATORY NO. 4
For each Asserted Claim of the Patents-in-Suit that Helios contends is invalid under 35 U.S.C. § 101 as directed to patent-ineligible subject matter:
(a) State in detail the factual and legal basis for such contention, including the identification of the alleged abstract idea, law of nature, or natural phenomenon to which Helios contends each such claim is directed at Step One of the Alice/Mayo two-step framework;
(b) Explain in detail why Helios contends each such claim lacks an "inventive concept" sufficient to transform it into a patent-eligible application under Step Two of the Alice/Mayo framework, including identification of the specific claim elements that Helios contends are conventional, routine, or well-understood;
(c) Identify each case, statute, regulation, agency guidance, authority, or other legal precedent on which Helios relies in support of its § 101 invalidity contentions;
(d) Identify each person with knowledge of the facts supporting such contentions, including a description of the nature and subject matter of each such person's knowledge; and
(e) Identify all documents relied upon or reviewed in developing such contentions, including but not limited to expert reports, technical analyses, prosecution history materials, and prior art references cited in connection with Helios's § 101 arguments.
INTERROGATORY NO. 5
For each Asserted Claim of the Patents-in-Suit that Helios contends is invalid under 35 U.S.C. § 102 as anticipated by prior art:
(a) Identify each prior art reference relied upon, including its full title, author(s), publication date, patent or application number (if applicable), publication venue, and country of publication or issuance;
(b) For each Asserted Claim alleged to be anticipated, provide a detailed, element-by-element comparison showing how each and every limitation of the claim is disclosed, taught, or described in the cited prior art reference, referencing specific portions (e.g., column and line numbers, paragraph numbers, figure numbers, or page numbers) of the prior art reference;
(c) Identify each person with knowledge of the facts supporting such anticipation contentions, including a description of the nature and subject matter of each such person's knowledge; and
(d) Identify all documents relied upon or reviewed in developing such contentions, including but not limited to claim charts, expert reports or analyses, prosecution history materials, and file wrapper contents of the Patents-in-Suit.
INTERROGATORY NO. 6
For each Asserted Claim of the Patents-in-Suit that Helios contends is invalid under 35 U.S.C. § 103 as obvious over the prior art:
(a) Identify each prior art reference or combination of references relied upon, including the full title, author(s), publication date, patent or application number (if applicable), publication venue, and country of publication or issuance for each reference;
(b) For each Asserted Claim alleged to be obvious, explain in detail the basis for combining the cited references, including any motivation to combine, teaching, suggestion, or reason that a person of ordinary skill in the art would have had to combine the references in the manner alleged, any reasonable expectation of success in arriving at the claimed invention, and identification of the specific differences between each reference (or combination of references) and the claimed invention;
(c) Describe any secondary considerations of nonobviousness of which Helios is aware, including but not limited to commercial success of the patented invention or any product practicing the Patents-in-Suit, long-felt but unsolved need in the art, failure of others to achieve the claimed invention, unexpected results, copying by others, industry skepticism, and licensing activity, and state Helios's position as to whether any such secondary considerations apply to the Asserted Claims;
(d) Identify each person with knowledge of the facts supporting such obviousness contentions, including a description of the nature and subject matter of each such person's knowledge; and
(e) Identify all documents relied upon or reviewed in developing such contentions, including but not limited to claim charts, expert reports or analyses, prosecution history materials, declarations or affidavits submitted during prosecution, and prior art search reports.
INTERROGATORY NO. 7
State in detail each and every factual and legal basis for Helios's counterclaim that one or more of the Patents-in-Suit are unenforceable, as set forth in Helios's Answer and Counterclaims filed on May 12, 2025 (Dkt. No. 28), including:
(a) The specific legal ground or grounds for unenforceability upon which Helios relies, including but not limited to inequitable conduct before the United States Patent and Trademark Office, prosecution laches, or patent misuse;
(b) A detailed description of the conduct alleged to render the Patents-in-Suit unenforceable, including the specific dates on which the alleged conduct occurred, the specific persons involved in such conduct (including their roles and their relationship to the patent applicant and/or assignee), and the specific acts or omissions that Helios contends constitute the basis for unenforceability;
(c) If Helios alleges inequitable conduct, identification of each material reference, piece of information, or prior art that Helios contends was withheld from or misrepresented to the Patent Office during prosecution of any of the Patents-in-Suit, and an explanation of why Helios contends such information was material and was withheld or misrepresented with the specific intent to deceive the Patent Office;
(d) Identification of each person with knowledge of the facts supporting such unenforceability contentions, including a description of the nature and subject matter of each such person's knowledge; and
(e) Identification of all documents relied upon or reviewed in developing such contentions, including but not limited to prosecution file histories, Information Disclosure Statements, communications with the Patent Office, and any internal documents of GenomeDx or its prosecution counsel that Helios contends are relevant.
INTERROGATORY NO. 8
Identify each person who was involved in the conception, design, development, testing, clinical validation, regulatory submission, or commercial launch of the ProstaSignal™ Genomic Classifier, including for each such person:
(a) Full legal name, current or last-known job title, and current or last-known employer, including the dates of such person's employment with Helios or any predecessor, affiliate, or subsidiary of Helios;
(b) A detailed description of such person's specific role and responsibilities in connection with the ProstaSignal™ test, including the specific aspects of the product's development (e.g., gene selection, algorithm design, training data curation, clinical validation study design and execution, regulatory strategy, commercial strategy, marketing) in which such person participated;
(c) The time period during which such person was involved in the activities described in subpart (b) above; and
(d) Whether such person is a current or former employee, independent contractor, or consultant of Helios, and if such person is no longer employed by or engaged by Helios, the date on which such person's employment or engagement terminated and such person's current employer and position, if known.
INTERROGATORY NO. 9
Describe in detail the technical design and operation of the ProstaSignal™ Genomic Classifier, including the following:
(a) The specific genes included in the ProstaSignal™ 24-gene expression panel, including the full gene name, official gene symbol (as designated by the HUGO Gene Nomenclature Committee), GenBank accession number or equivalent identifier (e.g., Ensembl Gene ID, RefSeq ID), and chromosomal locus for each gene;
(b) The method of gene selection employed in developing the ProstaSignal™ 24-gene panel, including the statistical or machine-learning methods used to identify and select the genes, the data sets used in the gene-selection process (including data set name, source repository, date of access, number of patient samples, and clinical endpoints), and the criteria or metrics used to evaluate gene candidates;
(c) The type and architecture of the machine-learning classifier used in the ProstaSignal™ test, including whether it employs a random-forest algorithm, a gradient-boosted decision tree algorithm (e.g., XGBoost, LightGBM, CatBoost), a support vector machine, a neural network, or any other classification algorithm, and a description of the hyperparameters, ensemble structure, and model configuration of the classifier;
(d) The training data used to train the classifier, including the total number of patient samples in the training cohort, the sources of the training data (e.g., institutional biobanks, public repositories such as GEO or TCGA, clinical trial data), the clinical endpoints used for model training (e.g., biochemical recurrence, metastasis, cancer-specific mortality), and the method of cross-validation or out-of-sample testing employed;
(e) The normalization methodology employed to process raw gene-expression data, including any reference gene panels, housekeeping genes, or standard normalization techniques (e.g., quantile normalization, RMA, FPKM, TPM) used, and any quality-control criteria applied to input samples;
(f) The manner in which the "ProstaScore" (expressed on a 0 to 100 scale) is generated from the raw output of the machine-learning classifier, including any transformation, scaling, calibration, or mapping function applied to convert the classifier's output into the ProstaScore;
(g) The specific thresholds and criteria used to classify patients into the Low, Intermediate, and High risk categories based on the ProstaScore, including the numerical cut points used and the clinical validation data supporting the selection of those cut points; and
(h) Whether and how the ProstaSignal™ test combines the ProstaScore with any clinical variables, including but not limited to Gleason score or Gleason grade group, pre-operative or post-operative PSA level, surgical margin status, pathological stage (e.g., T stage, N stage), patient age, and any other clinical covariates, and a description of the method by which such combination is effectuated (e.g., nomogram, multivariate model, composite index).
INTERROGATORY NO. 10
State whether, and if so when, Helios or any of its officers, directors, employees, agents, consultants, scientific advisors, investors, or board members first became aware of each of U.S. Patent Nos. 10,438,271, 11,204,893, and 11,891,647, and for each such patent:
(a) The date on which Helios or any person acting on Helios's behalf first became aware of the patent, and the circumstances of such awareness;
(b) The identity of the person(s) who first identified, discovered, or brought the patent to Helios's attention, including such person's title and role at Helios;
(c) Whether Helios obtained, commissioned, or received any freedom-to-operate analysis, opinion of counsel, clearance study, invalidity analysis, non-infringement opinion, or other assessment concerning the patent, and if so, identify the date of such analysis or opinion, the person or firm that prepared it, and the conclusions reached therein, to the extent not protected by applicable privilege — and if Helios asserts any privilege over such analysis or opinion, provide a privilege log entry identifying the date, author, recipients, and subject matter of the withheld document or communication;
(d) A description of any steps Helios took in response to becoming aware of the patent, including but not limited to any design-around efforts, modifications to the ProstaSignal™ test, consultations with patent counsel, internal assessments, or decisions to proceed with commercialization notwithstanding the patent; and
(e) Identification of all documents relating to Helios's awareness of, response to, analysis of, or evaluation of the Patents-in-Suit, including but not limited to internal memoranda, board presentations, investor communications, due diligence reports, and email correspondence.
INTERROGATORY NO. 11
State in detail the following financial information relating to the ProstaSignal™ Genomic Classifier for each calendar month from October 2024 through the date of Helios's response to this interrogatory:
(a) The total number of ProstaSignal™ tests performed, ordered, or accessioned during each such month;
(b) The total number of ProstaSignal™ tests for which reimbursement was sought from any payer, including private insurers, Medicare, Medicaid, and any other governmental or third-party payer, during each such month;
(c) The total number of ProstaSignal™ tests for which reimbursement was actually received during each such month, and the identity of the payer categories from which reimbursement was received;
(d) The total gross revenue received or accrued by Helios for ProstaSignal™ tests during each such month, including revenue from all sources (reimbursement, direct billing, research use, and any other source);
(e) The average reimbursement received per ProstaSignal™ test during each such month, broken down by payer category if available;
(f) The total costs directly attributable to performing ProstaSignal™ tests during each such month, broken down by major cost category, including but not limited to reagents and consumables, laboratory labor (including technician and pathologist time), equipment depreciation and maintenance, sample acquisition and processing, quality control, shipping, and allocated overhead;
(g) The total net profits (or net losses) attributable to ProstaSignal™ tests during each such month, calculated as gross revenue minus total directly attributable costs; and
(h) Any projections, forecasts, budgets, financial models, business plans, or investor presentations prepared by or for Helios relating to future ProstaSignal™ revenue, test volume, costs, profitability, or market share, including the date of preparation, author(s), and the assumptions underlying such projections.
INTERROGATORY NO. 12
Describe in detail Helios's marketing, sales, and commercialization strategy for the ProstaSignal™ Genomic Classifier, including:
(a) Identification of all marketing materials, promotional literature, sales presentations, product brochures, white papers, webinar content, conference presentations, social media content, website content, and advertisements created, distributed, or disseminated by or on behalf of Helios in connection with the ProstaSignal™ test, including the date of creation or distribution, author(s), target audience, and a description of the content of each;
(b) A description of any communications, meetings, presentations, or other interactions with healthcare providers, hospitals, pathology groups, urology practices, oncology practices, payers, Medicare Administrative Contractors, or other institutions in which the ProstaSignal™ test was compared to, contrasted with, or distinguished from GenomeDx's Decipher® test, including the date of each such communication, the participants, and a summary of the substance of the comparison;
(c) Identification of all competitive analyses, market studies, market intelligence reports, competitive landscape assessments, win/loss analyses, or similar reports prepared by or for Helios that reference GenomeDx, the Decipher® test, GenomeDx's market share, GenomeDx's pricing, GenomeDx's clinical evidence base, or the Patents-in-Suit, including the date, author(s), and a description of the conclusions or findings of each;
(d) Identification of each healthcare institution, hospital, clinic, physician practice, laboratory, integrated delivery network, accountable care organization, or other customer or account that has ordered, purchased, used, or received results from the ProstaSignal™ test, including the name and location of each such entity, the date of the first order, and the approximate total number of tests ordered by each; and
(e) Identification of each person with knowledge of the foregoing, including a description of the nature and subject matter of each such person's knowledge.
INTERROGATORY NO. 13
Identify all license agreements, collaboration agreements, co-development agreements, joint ventures, supply agreements, distribution agreements, service agreements, or other contractual arrangements relating to the ProstaSignal™ Genomic Classifier or any technology, intellectual property, or methodology embodied therein, including for each such agreement:
(a) The identity of each party to such agreement, including the party's full legal name, jurisdiction of organization, and principal place of business;
(b) The date of execution and the effective dates of the agreement;
(c) A description of the rights granted, obligations assumed, and the subject matter covered by such agreement, including whether the agreement grants any license to practice, make, use, sell, or offer for sale any technology, method, or product;
(d) All material financial terms, including but not limited to royalty rates (whether running or paid-up), lump-sum payments, upfront license fees, milestone payments, minimum royalties, and any equity consideration or other non-cash compensation; and
(e) Whether any such agreement relates to, references, or was entered into in connection with any of the Patents-in-Suit, any intellectual property owned by GenomeDx, the Decipher® test, or any other genomic classifier for prostate cancer prognosis.
INTERROGATORY NO. 14
Identify each and every item of prior art, whether or not previously disclosed in this litigation, that Helios contends is relevant to the validity of any Asserted Claim of the Patents-in-Suit, including but not limited to patents, published patent applications, journal articles, conference papers, published abstracts, dissertations, publicly available databases, publicly available products, public presentations, public uses, offers for sale, or any other category of prior art under 35 U.S.C. §§ 102 and 103, other than those already identified in Helios's invalidity contentions served on November 3, 2025 or in Helios's Answer and Counterclaims (Dkt. No. 28), and for each such prior art reference:
(a) The full citation, including title, author(s), publication date, publisher or patent office, patent or application number (if applicable), journal name, volume, issue, and page numbers (if applicable), and any URL or accession number;
(b) Identification of the specific Asserted Claim(s) to which each prior art reference is contended to be relevant, and whether Helios contends the reference is relevant to anticipation under § 102, obviousness under § 103, or both;
(c) A description of the relevance of each prior art reference to the identified Asserted Claim(s), including identification of the specific teachings, disclosures, or elements of the reference that Helios contends bear upon the validity of such claims; and
(d) The date on which Helios or its counsel first became aware of each such prior art reference, and the circumstances under which the reference was identified or discovered.
INTERROGATORY NO. 15
Describe in detail Helios's contention that the ProstaSignal™ Genomic Classifier was independently developed without reliance upon or derivation from GenomeDx's patented methods, the Decipher® test, or the Patents-in-Suit, including:
(a) A detailed chronological timeline of the development of the ProstaSignal™ test, from initial concept through commercial launch on October 7, 2024, identifying significant milestones, decision points, design changes, and the dates on which each occurred;
(b) Identification of each publicly available gene-expression data set used in the development, training, validation, or testing of the ProstaSignal™ classifier, including the data set name, accession number or identifier, source repository (e.g., Gene Expression Omnibus, The Cancer Genome Atlas, ArrayExpress, cBioPortal), the date(s) on which each data set was accessed or downloaded, the number of patient samples in each data set, the platform(s) on which gene expression was measured (e.g., microarray, RNA-seq), and the clinical endpoints available in each data set;
(c) Identification of each person who participated in the independent development of the ProstaSignal™ classifier algorithm, including the nature and scope of each such person's contribution, their qualifications and relevant expertise, and whether such person had any prior employment, consulting, or collaborative relationship with GenomeDx or any of the named inventors of the Patents-in-Suit;
(d) A description of the machine-learning methods, feature-selection techniques, data-processing pipelines, and statistical methods used to develop the ProstaSignal™ classifier, including the software tools, programming languages, and computational platforms used;
(e) Whether any aspect of the ProstaSignal™ test — including its gene panel, classifier architecture, normalization methodology, risk-stratification thresholds, or combined clinical-genomic model — was designed, modified, adapted, or altered in light of, in response to, or with knowledge of any of the Patents-in-Suit, GenomeDx's Decipher® test, or any publication, presentation, or public disclosure by GenomeDx concerning the Decipher® test or its underlying technology; and
(f) Identification of all documents that evidence or relate to the independent development of the ProstaSignal™ test, including but not limited to laboratory notebooks, electronic research notebooks, internal research reports, technical memoranda, presentations to management or the board of directors, email communications, Meridian Solutions or Teams messages, meeting minutes, patent disclosures, grant applications, and any other records documenting the conception, design, development, testing, and validation of the ProstaSignal™ classifier.
Dated: February 10, 2026
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
By: ________
Catherine Bloom (Cal. Bar No. 247891) cbloom@calderwoodharkness.com
Alan Ngo (Cal. Bar No. 312456) ango@calderwoodharkness.com
Peter Vassiliev (Cal. Bar No. 298034) pvassiliev@calderwoodharkness.com
Wendy Schultz (Cal. Bar No. 305712) wschultz@calderwoodharkness.com
CALDERWOOD & HARKNESS LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 632-8500 Facsimile: (415) 632-8501
Attorneys for Plaintiff Genome Dx Therapeutics Inc.
CERTIFICATE OF SERVICE
I, Peter Vassiliev, hereby certify that on February 10, 2026, I caused the foregoing PLAINTIFF GENOME DX THERAPEUTICS INC.'S FIRST SET OF INTERROGATORIES TO DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC. (NOS. 1–15) to be served upon counsel for Defendant Helios Precision Diagnostics, Inc. via electronic mail and via Sundial Data Systems overnight courier, addressed to:
Marcus Pellegrini, Esq. Danielle Forrest, Esq. Owen Chu, Esq. RIDGECREST DURNEVAL LLP One Federal Street, Suite 3400 Boston, Massachusetts 02110 Telephone: (617) 405-2200 mpellegrini@ridgecrestkirkpatrick.com dforrest@ridgecrestkirkpatrick.com ochu@ridgecrestkirkpatrick.com
and
RIDGECREST DURNEVAL LLP 350 South Grand Avenue, Suite 2800 Los Angeles, California 90071
________________________________________
Peter Vassiliev
GENOME DX THERAPEUTICS INC., | Case No. 3:25-cv-01847-JWL
<!-- indent:2 -->Plaintiff,<!-- /indent --> | Hon. James W. Larkin
v. | PLAINTIFF GENOME DX THERAPEUTICS INC.'S FIRST SET OF INTERROGATORIES TO DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC. (NOS. 1–15)
HELIOS PRECISION DIAGNOSTICS, INC.,
<!-- indent:2 -->Defendant.<!-- /indent -->
Propounding Party: | Genome Dx Therapeutics Inc.
Responding Party: | Helios Precision Diagnostics, Inc.
Set Number: | One
Date Served: | February 10, 2026

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA

PRELIMINARY STATEMENT

DEFINITIONS

INSTRUCTIONS

INTERROGATORIES

INTERROGATORY NO. 1

INTERROGATORY NO. 2

INTERROGATORY NO. 3

INTERROGATORY NO. 4

INTERROGATORY NO. 5

INTERROGATORY NO. 6

INTERROGATORY NO. 7

INTERROGATORY NO. 8

INTERROGATORY NO. 9

INTERROGATORY NO. 10

INTERROGATORY NO. 11

INTERROGATORY NO. 12

INTERROGATORY NO. 13

INTERROGATORY NO. 14

INTERROGATORY NO. 15

CALDERWOOD & HARKNESS LLP

CERTIFICATE OF SERVICE

HELIOS PRECISION DIAGNOSTICS, INC.,

Record

Parties

Dates

Amounts