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

vassiliev-declaration-motion-to-compel.docx DOCUMENT Litigation

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UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION

DECLARATION OF PETER VASSILIEV IN SUPPORT OF PLAINTIFF'S MOTION TO COMPEL PRODUCTION OF DOCUMENTS RESPONSIVE TO REQUESTS FOR PRODUCTION NOS. 22, 23, AND 31

Date: January 30, 2026

I, Peter Vassiliev, hereby declare under penalty of perjury under 28 U.S.C. § 1746 as follows:

I. INTRODUCTION AND DECLARANT IDENTIFICATION

1. I am an attorney duly admitted to practice before the United States District Court for the Northern District of California and a member in good standing of the California State Bar (Bar No. 318742). I am a Lead Associate in the intellectual Property Litigation group at Calderwood & Harkness LLP, located at 555 Mission Street, Suite 3100, San Francisco, California 94105. I hold a Doctor of Philosophy degree in Bioinformatics from the University of California, San Diego, which I received in 2017. I am a seventh-year associate at Calderwood & Harkness LLP.

2. I am a member of the litigation team representing Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx" or "Plaintiff") in the above-captioned patent infringement action, working under the supervision of Catherine Bloom, the Responsible Partner for this engagement. In this capacity, I have been actively involved in all aspects of fact discovery in this case, including the drafting and service of Plaintiff's First Set of Requests for Production of Documents, the review and analysis of Defendant Helios Precision Diagnostics, Inc.'s ("Helios" or "Defendant") responses and production thereto, the review and analysis of Helios's privilege log, and the meet-and-confer process with defense counsel concerning the discovery disputes at issue in the pending motion.

3. I have personal knowledge of the facts set forth in this declaration and, if called as a witness, I could and would competently testify to them.

4. I submit this declaration in support of Plaintiff GenomeDx's Motion to Compel Production of Documents Responsive to Plaintiff's First Set of Requests for Production of Documents, Nos. 22, 23, and 31 (the "Motion to Compel"). Specifically, GenomeDx seeks the production of thirty-four (34) documents that Defendant Helios has improperly withheld on the basis of attorney-client privilege and/or work-product protection, as reflected in Helios's privilege log.

II. BACKGROUND OF THE LITIGATION

5. GenomeDx filed this patent infringement action against Helios on March 28, 2025. The Complaint asserts claims of infringement of three United States patents: U.S. Patent No. 10,438,271 (the "'271 Patent"), U.S. Patent No. 11,204,893 (the "'893 Patent"), and U.S. Patent No. 11,891,647 (the "'647 Patent") (collectively, the "Asserted Patents"). Each of the Asserted Patents is owned by GenomeDx and covers proprietary genomic-classifier methods for prostate cancer prognosis, including novel combinations of gene-expression signatures, algorithmic classification methods, and clinical-decision-support outputs that enable physicians to assess the risk of metastatic disease following prostatectomy.

6. GenomeDx alleges that Helios's ProstaSignal™ Genomic Classifier (the "Accused Product"), which was commercially launched on or about October 7, 2024, infringes asserted claims of all three of the Asserted Patents. The ProstaSignal™ Genomic Classifier is a laboratory-developed test that analyzes gene-expression patterns in prostate tumor tissue to generate a risk score used in clinical decision-making regarding adjuvant treatment following radical prostatectomy — functionality that is covered by the claims of the Asserted Patents.

7. On May 12, 2025, Helios filed its Answer and Counterclaims. Helios's Answer asserts affirmative defenses of invalidity under 35 U.S.C. §§ 101 (patent-ineligible subject matter), 102 (anticipation), and 103 (obviousness), as well as defenses of non-infringement and unenforceability. Helios's Counterclaims seek declaratory judgments of invalidity and non-infringement with respect to each of the three Asserted Patents.

8. On January 13, 2026, the Court (Hon. Jessica W. Langston, presiding) issued an Order denying Helios's Motion to Dismiss Counts II and III of GenomeDx's Complaint under 35 U.S.C. § 101, finding that GenomeDx had adequately pleaded that the claimed inventions were directed to patent-eligible subject matter. The Court's Order confirmed that the infringement claims asserted against the '893 Patent and the '647 Patent will proceed to discovery and, ultimately, trial.

9. The Scheduling Order in this case was issued on June 18, 2025, by Judge Langston. Among other deadlines, the Scheduling Order establishes a fact discovery close date of March 6, 2026. Given that the instant motion concerns documents that are directly relevant to GenomeDx's claims of willful infringement, damages, and Helios's state of mind regarding GenomeDx's patent rights, the timely resolution of this discovery dispute is essential to ensure that GenomeDx can complete its fact-discovery program within the time allotted by the Scheduling Order.

III. THE RELEVANT REQUESTS FOR PRODUCTION

A. Request for Production No. 22

10. Request for Production No. 22 ("RFP No. 22"), as set forth in Plaintiff's First Set of Requests for Production of Documents, requests the following:

All pre-launch business plans, strategic plans, and market analyses relating to the ProstaSignal™ Genomic Classifier that reference, discuss, or analyze (a) U.S. Patent Nos. 10,438,271; 11,204,893; and/or 11,891,647; (b) GenomeDx's Decipher® test; or (c) GenomeDx's intellectual property portfolio.

11. RFP No. 22 is directly relevant to multiple issues in this case, including: (a) Helios's knowledge of GenomeDx's patents prior to the commercial launch of the ProstaSignal™ Genomic Classifier, which bears on GenomeDx's claim of willful infringement and the potential for enhanced damages under 35 U.S.C. § 284; (b) Helios's competitive positioning of the ProstaSignal™ product relative to GenomeDx's Decipher® test, which bears on market share, lost profits, and the reasonable-royalty analysis; and (c) Helios's assessment of GenomeDx's intellectual property as a factor in its commercial strategy, which is relevant to both liability and damages.

B. Request for Production No. 23

12. Request for Production No. 23 ("RFP No. 23") requests the following:

All board of directors presentations, board minutes, and board-level reports relating to the ProstaSignal™ Genomic Classifier that reference or discuss (a) Genome Dx Therapeutics Inc.; (b) GenomeDx's Decipher® test; or (c) any freedom-to-operate analysis, patent clearance analysis, or assessment of intellectual property risk.

13. RFP No. 23 is directly relevant to Helios's corporate state of mind, its awareness of GenomeDx's patent rights at the board level, and the degree to which Helios's board of directors considered and evaluated the risk of patent infringement before approving the commercial launch of the ProstaSignal™ Genomic Classifier. Such evidence is highly probative of willfulness, as board-level knowledge and decision-making reflects the deliberate, considered actions of the company's highest governing body.

C. Request for Production No. 31

14. Request for Production No. 31 ("RFP No. 31") requests the following:

All investor presentations, investor memoranda, and communications with investors — including but not limited to Corinth Ventures Fund III, LP and Aether Life Sciences Partners — concerning the ProstaSignal™ Genomic Classifier that reference or discuss (a) GenomeDx's patents (U.S. Patent Nos. 10,438,271; 11,204,893; and/or 11,891,647); (b) GenomeDx's Decipher® test; (c) the competitive landscape for genomic classifiers in prostate cancer prognosis; or (d) intellectual property risks.

15. RFP No. 31 is relevant to Helios's own assessment of patent risk, including how Helios characterized that risk to sophisticated investors who were asked to fund the development and commercialization of the ProstaSignal™ product. These materials are also relevant to GenomeDx's damages theories, as investor presentations and memoranda frequently contain detailed market projections, revenue forecasts, pricing assumptions, and competitive analyses that reflect the commercial expectations and market value of the accused product.

IV. HELIOS'S RESPONSES AND PRODUCTION

A. Initial Responses

16. GenomeDx served its First Set of Requests for Production of Documents (Nos. 1–47) on Helios on January 27, 2025. Helios served its written responses and objections to the Requests for Production on a rolling basis, beginning with certain categories of responsive documents and continuing through late fall 2025.

17. In response to RFP Nos. 22, 23, and 31, Helios produced a total of 1,247 documents, consisting primarily of internal marketing materials, publicly available investor presentations, high-level business summaries, and communications among Helios employees that do not reference GenomeDx's patents or intellectual property in any meaningful detail. While GenomeDx appreciates the documents that have been produced, the production is materially incomplete because Helios has withheld eighty-three (83) documents on the basis of attorney-client privilege and/or work-product protection, as reflected in the privilege log that Helios produced.

B. The Privilege Log

18. Helios's privilege log identifies eighty-three (83) documents withheld across all categories of Requests for Production, asserting attorney-client privilege, work-product protection, or both as the basis for withholding each document.

19. After careful review and analysis of the privilege log entries, GenomeDx challenges thirty-four (34) of the eighty-three (83) withheld documents as improperly withheld. GenomeDx does not challenge the remaining forty-nine (49) entries on the privilege log, which appear to involve documents whose dominant purpose is the seeking or rendering of legal advice and which were not shared with third parties outside the scope of the attorney-client relationship.

20. The thirty-four (34) challenged documents span the following categories, as described in Helios's privilege log:

(a) Twelve (12) documents described as board presentations or board-level memoranda prepared for or presented to Helios's board of directors, with subject lines such as "Q2 2024 Board Presentation — ProstaSignal™ Update," "Board Memo: Competitive Landscape and Market Entry Strategy," and "ProstaSignal™ Launch Readiness — Board Summary";

(b) Nine (9) documents described as investor presentations or investor update materials that were shared with Corinth Ventures Fund III, LP ("Corinth Ventures") and/or Aether Life Sciences Partners ("Aether"), with subject lines such as "Corinth Ventures Quarterly Update — ProstaSignal™ Development and Commercialization," "Investor Deck — Series B Expansion Strategy," and "Aether/Corinth Update: ProstaSignal™ Clinical Validation and Market Opportunity";

(c) Eight (8) documents described as internal business plans or strategy memoranda with references to legal advice, with subject lines such as "ProstaSignal™ Market Launch Strategy — Confidential," "Competitive Analysis: Decipher® vs. ProstaSignal™," and "Five-Year Revenue Projection Model — ProstaSignal™ Platform";

(d) Five (5) documents described as email communications between Helios executives — specifically Dr. Nathan Ashford (Chief Executive Officer), Dr. Elaine Kossack (Chief Scientific Officer), and Derek Mallinson (Vice President of Commercial Operations) — and Sara Whitmore (General Counsel), where those emails were also sent to, copied to, or shared with non-legal business personnel within Helios and/or with representatives of Corinth Ventures and/or Aether.

21. A true and correct copy of the relevant portions of Helios's privilege log identifying the thirty-four (34) challenged documents, including each document's privilege log entry number, date, author(s), recipient(s), document description, and the privilege basis asserted, is attached hereto as Exhibit D and incorporated herein by reference.

V. MEET-AND-CONFER EFFORTS

A. Initial Correspondence — December 12, 2025

22. After reviewing the privilege log entries that accompanied Helios's early rolling productions, I sent a detailed letter dated December 12, 2025 to Marcus Pellegrini, Lead Partner at Ridgecrest Durneval LLP, One Federal Street, Suite 3400, Boston, Massachusetts 02110, counsel of record for Defendant Helios. In that letter, I identified GenomeDx's specific concerns regarding thirty-four (34) privilege log entries and requested that defense counsel meet and confer in good faith regarding those entries.

23. In the December 12, 2025 letter, I explained that many of the withheld documents appeared, based on their privilege log descriptions, to be primarily business documents — including board presentations, investor materials, and strategic plans — whose dominant purpose was commercial decision-making, not the seeking or rendering of legal advice. I noted that the inclusion of Sara Whitmore (General Counsel) as a copy recipient or contributor did not, standing alone, transform an otherwise business communication into a privileged legal communication. I further observed that documents shared with third-party investors, including Corinth Ventures Fund III, LP and Aether Life Sciences Partners, appeared to have been disclosed outside the scope of any attorney-client relationship, thereby waiving any privilege that might otherwise have attached. I requested that Helios re-evaluate its privilege assertions and produce the challenged documents, or alternatively agree to a telephonic meet-and-confer to discuss the issues in greater detail.

24. A true and correct copy of my December 12, 2025 letter to Marcus Pellegrini is attached hereto as Exhibit A and incorporated herein by reference.

B. Telephone Conference — December 19, 2025

25. On December 19, 2025, I participated in a telephonic meet-and-confer conference with Catherine Bloom, Responsible Partner at Calderwood & Harkness LLP. Representing Helios on the call were Marcus Pellegrini, Lead Partner, and Danielle Forrest, Senior Associate, both of Ridgecrest Durneval LLP.

26. During the approximately forty-five-minute telephone conference, Mr. Pellegrini and Ms. Forrest took the position that all thirty-four (34) of the challenged documents were protected by attorney-client privilege because Sara Whitmore, Helios's General Counsel, was either copied on, contributed to, or otherwise participated in the creation or dissemination of each document. Mr. Pellegrini stated that Ms. Whitmore's involvement in each communication was in her capacity as legal counsel and that her contributions reflected legal advice regarding freedom-to-operate, patent clearance, and intellectual property risk management.

27. Ms. Bloom and I responded to defense counsel's position with several arguments. First, we explained that the mere inclusion of in-house counsel on a communication or document does not establish attorney-client privilege, particularly where the dominant purpose of the communication was business rather than legal in nature. We cited applicable Ninth Circuit authority for the proposition that the privilege protects only those communications made for the purpose of seeking or providing legal advice, and that where in-house counsel performs a business function, the privilege does not attach. Second, we argued that documents shared with third-party investors — specifically Corinth Ventures Fund III, LP and Aether Life Sciences Partners — destroyed any privilege that might otherwise have attached, because those entities are not within the attorney-client relationship and their receipt of allegedly privileged materials constitutes voluntary disclosure to third parties.

28. Mr. Pellegrini responded that Helios's position was that the common-interest doctrine protected communications shared with its investors because Corinth Ventures and Aether had a shared legal interest in Helios's patent risk management. Ms. Bloom and I disagreed, noting that an investor's financial interest in the success of a portfolio company is a business interest, not a common legal interest, and that the common-interest doctrine requires a shared interest in pending or anticipated litigation or a common legal strategy, not merely a shared desire for the company's commercial success.

29. After extensive discussion, the parties were unable to reach agreement on any of the thirty-four (34) challenged documents. Mr. Pellegrini stated that Helios would maintain its privilege assertions in full. I contemporaneously memorialized the substance of the December 19, 2025 call in my internal notes.

C. Follow-Up Letter — January 8, 2026

30. On January 8, 2026, I sent a follow-up letter to Marcus Pellegrini and Danielle Forrest at Ridgecrest Durneval LLP. In that letter, I reiterated GenomeDx's position that the thirty-four (34) challenged documents had been improperly withheld, and I identified each document by its privilege log entry number, date, and description. I requested that Helios produce the documents by January 20, 2026, to allow sufficient time for review before the close of fact discovery on March 6, 2026.

31. The January 8, 2026 letter also noted that the Stipulated Protective Order entered on December 18, 2025 by Judge Langston (Dkt. No. 74) — which establishes two tiers of protection, "Confidential" and "Highly Confidential — Attorneys' Eyes Only" — provides adequate safeguards for any sensitive business information contained in the challenged documents. I emphasized that Helios could designate the produced documents at either tier of protection, thereby ensuring that the documents would be used solely for purposes of this litigation and would not be disclosed publicly or to unauthorized individuals.

32. A true and correct copy of my January 8, 2026 letter to Marcus Pellegrini and Danielle Forrest is attached hereto as Exhibit B and incorporated herein by reference.

D. Helios's Response — January 15, 2026

33. On January 15, 2026, Danielle Forrest of Ridgecrest Durneval LLP responded on behalf of Helios by letter addressed to me. Ms. Forrest's letter refused to produce any of the thirty-four (34) challenged documents.

34. Ms. Forrest's letter asserted three grounds for Helios's continued withholding of the documents:

(1) First, Ms. Forrest stated that each of the thirty-four documents reflects or incorporates legal advice from General Counsel Sara Whitmore regarding freedom-to-operate and patent clearance, and that accordingly each document is protected in its entirety by the attorney-client privilege;

(2) Second, Ms. Forrest argued that sharing the documents with members of Helios's board of directors and with Helios's investors does not waive privilege because those communications were made in furtherance of obtaining legal advice for corporate decision-making, and that the recipients were necessary participants in the corporate decision-making process that required legal input;

(3) Third, Ms. Forrest asserted that investor communications are protected under the common-interest doctrine because Corinth Ventures Fund III, LP and Aether Life Sciences Partners have a shared legal interest in Helios's patent risk management, and that the sharing of documents with those entities was undertaken pursuant to an implicit common-interest arrangement.

35. A true and correct copy of Danielle Forrest's January 15, 2026 response letter is attached hereto as Exhibit C and incorporated herein by reference.

E. Exhaustion of Meet-and-Confer

36. Despite GenomeDx's good-faith efforts to resolve this discovery dispute without Court intervention, the parties remain at an impasse regarding all thirty-four (34) challenged documents. Over the course of approximately seven weeks — from December 12, 2025 through January 15, 2026 — the parties exchanged three written communications (December 12, 2025; January 8, 2026; and January 15, 2026) and participated in one telephonic meet-and-confer conference (December 19, 2025). At each stage, GenomeDx identified its specific concerns with particularity, provided legal authority supporting its position, and proposed a resolution. At each stage, Helios declined to produce any of the challenged documents or to offer any compromise.

37. Consistent with Civil Local Rule 37-1 of the Northern District of California and the Northern District of California's Guidelines for discovery, GenomeDx has exhausted its meet-and-confer obligations before filing the instant Motion to Compel.

VI. ANALYSIS OF THE CHALLENGED DOCUMENTS

A. The 34 Challenged Documents Are Primarily Business Documents

38. Based on my review of the privilege log descriptions provided by Helios, the thirty-four (34) challenged documents are board presentations, investor materials, business plans, and strategy memoranda whose dominant purpose is commercial decision-making — not the seeking or rendering of legal advice. The privilege log descriptions themselves reveal the business character of these documents. For example, the log entries reference subjects such as "ProstaSignal™ market launch strategy," "competitive positioning vs. Decipher® test," "projected revenue and market share analysis," "investor update on product development timeline," "Series B expansion strategy," "five-year revenue projection model," and "launch readiness — board summary." These are quintessentially business topics that relate to Helios's commercial operations, marketing strategy, financial projections, and investor relations.

39. While some of these documents may contain incidental references to legal topics or may have been shared with or reviewed by Sara Whitmore in her capacity as General Counsel, the inclusion of in-house counsel on a communication or the presence of incidental legal references does not transform a business document into a privileged legal communication. Under Ninth Circuit law, the attorney-client privilege protects only those communications whose primary purpose is the seeking or providing of legal advice. Where a document is primarily a business communication — as the privilege log descriptions of the thirty-four challenged documents indicate — the mere fact that an attorney was involved does not render the document privileged.

40. In the context of in-house counsel, this distinction is particularly important. In-house counsel frequently perform dual roles within corporations, serving both as legal advisors and as business participants in corporate strategy, product development, and operational decision-making. When in-house counsel acts in a business capacity — for example, by contributing to market strategy presentations, participating in investor updates, or reviewing business plans for non-legal purposes — those activities do not generate attorney-client privilege. The burden is on the party asserting privilege to demonstrate that the communication was made for the primary purpose of seeking or providing legal advice, and the privilege log descriptions provided by Helios fail to carry that burden with respect to any of the thirty-four challenged documents.

B. Documents Shared with Third-Party Investors

41. At least nine (9) of the thirty-four (34) challenged documents were shared with Corinth Ventures Fund III, LP ("Corinth Ventures") and/or Aether Life Sciences Partners ("Aether"). Corinth Ventures is Helios's majority investor, holding 58.7% of Helios's equity, and is managed by Priya Chandrasekaran, with offices at 399 Boylston Street, Suite 1100, Boston, Massachusetts 02116. Aether is a Series A investor holding approximately 11.0% of Helios's equity. Both entities are sophisticated venture-capital and life-sciences investment firms that have a financial — not a legal — interest in Helios's commercial success.

42. It is well established that voluntary disclosure of otherwise privileged communications to third parties who are outside the attorney-client relationship constitutes a waiver of attorney-client privilege. Helios's disclosure of these nine (9) documents to Corinth Ventures and Aether destroyed any privilege that might have attached to those communications. Neither Corinth Ventures nor Aether is Helios's attorney, and neither entity falls within the scope of the attorney-client relationship between Helios and its General Counsel, Sara Whitmore, or between Helios and its outside counsel at Ridgecrest Durneval LLP.

43. Helios's assertion that the common-interest doctrine protects these communications is without merit. The common-interest doctrine (sometimes referred to as the "joint defense" or "community of interest" doctrine) is a narrow exception to the general rule that disclosure to third parties waives privilege. To invoke the common-interest doctrine, the party asserting privilege must demonstrate that the parties share a common legal interest — not merely a common business, financial, or commercial interest — and that the communications were made in furtherance of a joint legal strategy or in connection with pending or anticipated litigation.

44. An investor's interest in the financial success of its portfolio company is a quintessential business interest, not a common legal interest. Corinth Ventures and Aether are not co-defendants in this litigation, are not parties to any related legal proceeding, and are not engaged in a joint legal defense strategy with Helios. Their interest in Helios's patent risk management is derivative of and subordinate to their financial interest in the return on their investment. Under established authority, this type of shared financial or commercial interest is insufficient to invoke the common-interest doctrine. Helios has not provided, and cannot provide, evidence that Corinth Ventures or Aether entered into any written or oral common-interest agreement with Helios, or that the documents were shared pursuant to such an agreement for the purpose of advancing a common legal strategy.

C. Board Presentations with Mixed Business and Legal Content

45. Twelve (12) of the thirty-four (34) challenged documents are described in the privilege log as board presentations or board-level memoranda. To the extent that any of these documents contain mixed business and legal content, the business portions of those documents are not protected by attorney-client privilege. The privilege does not provide blanket protection for an entire document merely because some portion of the document references or incorporates legal advice. Rather, only those specific communications made for the purpose of seeking or providing legal advice are privileged, and the remaining business content must be produced.

46. The composition of Helios's board of directors further undermines Helios's privilege assertions with respect to these twelve (12) board presentations. Based on publicly available information and Helios's own filings in this case, Helios's board includes representatives of Corinth Ventures, including at least one board seat occupied by a Corinth Ventures designee. The sharing of allegedly privileged documents with a board that includes investor representatives further extends the disclosure beyond the bounds of any attorney-client privilege, without an adequate showing that the common-interest doctrine applies, for the reasons set forth above.

D. Internal Emails Shared Beyond Counsel

47. Five (5) of the thirty-four (34) challenged documents are described as email communications between Helios executives — specifically Dr. Nathan Ashford (Chief Executive Officer), Dr. Elaine Kossack (Chief Scientific Officer), and Derek Mallinson (Vice President of Commercial Operations) — and Sara Whitmore (General Counsel), where those emails were also sent to or shared with non-legal business personnel within Helios and, in some instances, with representatives of Corinth Ventures and/or Aether. To the extent that these email communications reflect primarily business discussion — such as commercial strategy, competitive positioning, or market analysis — with incidental legal input from Ms. Whitmore, those communications are not privileged. The broad distribution of these emails to non-legal personnel and, in some cases, to third-party investor representatives, confirms that the dominant purpose of the communications was business, not legal.

VII. RELEVANCE OF THE 34 CHALLENGED DOCUMENTS

48. The thirty-four (34) withheld documents are directly relevant to GenomeDx's claims and damages theories in this action. Specifically:

(a) Willful Infringement. Board presentations and investor materials discussing GenomeDx's patents, the Decipher® test, or freedom-to-operate analyses are probative of Helios's pre-launch knowledge of GenomeDx's patent rights and the deliberateness of Helios's decision to launch the ProstaSignal™ Genomic Classifier notwithstanding those rights. Evidence that Helios's board of directors and investor base were aware of GenomeDx's intellectual property and the risk of infringement is highly relevant to GenomeDx's claim of willful infringement and to the potential for enhanced damages under 35 U.S.C. § 284. The Federal Circuit has recognized that evidence of pre-suit knowledge of the asserted patents, and the accused infringer's assessment of infringement risk, is among the most probative evidence on the question of willfulness.

(b) Damages. Business plans and market analyses showing Helios's projected revenue from the ProstaSignal™ Genomic Classifier, its pricing strategy (including the average reimbursement rate of approximately $3,820 per test), and its competitive positioning against GenomeDx's Decipher® test are directly relevant to GenomeDx's lost-profits analysis and reasonable-royalty calculation. Investor presentations and memoranda, in particular, frequently contain detailed financial projections and market-share assumptions that reflect the commercial value and anticipated commercial success of the accused product. This information is essential to determining the appropriate measure of damages.

(c) Infringement State of Mind. Documents showing Helios's awareness of the significant overlap between the ProstaSignal™ Genomic Classifier and GenomeDx's patented gene set — specifically, the nineteen-of-twenty-four gene overlap between ProstaSignal™ and the gene signatures claimed in GenomeDx's patents — and any discussions about designing around GenomeDx's patents, are highly probative of infringement and of Helios's knowledge and intent. Such documents may reveal that Helios was aware that its product substantially overlapped with GenomeDx's patented technology and nevertheless proceeded with commercialization, which is directly relevant to both liability and enhanced damages.

49. The importance of these documents to GenomeDx's case cannot be overstated. Willful infringement, damages, and the accused infringer's state of mind are among the central issues in this patent infringement action, and the thirty-four (34) challenged documents — by Helios's own privilege log descriptions — are squarely directed to those issues. Helios should not be permitted to use overbroad and unsupported privilege assertions to shield from discovery the very documents that are most probative of its knowledge, intent, and commercial strategy regarding GenomeDx's patented technology.

VIII. THE PROTECTIVE ORDER PROVIDES ADEQUATE SAFEGUARDS

50. On December 18, 2025, the Court entered the parties' Stipulated Protective Order (Dkt. No. 74), which establishes two tiers of confidentiality protection: "Confidential" and "Highly Confidential — Attorneys' Eyes Only." The Stipulated Protective Order was the product of good-faith negotiations between Calderwood & Harkness LLP and Ridgecrest Durneval LLP, following a meet-and-confer conference held on December 5, 2025.

51. The Stipulated Protective Order provides robust safeguards against the public disclosure or misuse of sensitive business information. Documents designated as "Confidential" may be viewed by a defined group of individuals, including outside counsel, in-house counsel, experts, and certain litigation support personnel. Documents designated as "Highly Confidential — Attorneys' Eyes Only" are subject to even more restrictive access limitations, permitting review only by outside counsel, retained experts, and specifically designated litigation support staff. The Protective Order prohibits the use of designated materials for any purpose other than this litigation and imposes obligations of return or destruction upon the conclusion of the case.

52. Helios may designate any or all of the thirty-four (34) challenged documents at either tier of the Stipulated Protective Order, thereby ensuring that any sensitive business information contained in those documents is adequately protected from public disclosure, competitive harm, or any other misuse. The existence of the Stipulated Protective Order undermines any argument by Helios that production of the challenged documents would cause competitive harm or prejudice. The Court's Protective Order was designed precisely to address such concerns and to facilitate the full and fair exchange of relevant discovery materials while safeguarding legitimate confidentiality interests.

IX. LIST OF EXHIBITS

53. The following exhibits are attached hereto and incorporated by reference into this declaration:

Exhibit A: Letter from Peter Vassiliev, Calderwood & Harkness LLP, to Marcus Pellegrini, Ridgecrest Durneval LLP, dated December 12, 2025, identifying the thirty-four (34) challenged privilege log entries and requesting a meet-and-confer conference.

Exhibit B: Follow-up letter from Peter Vassiliev, Calderwood & Harkness LLP, to Marcus Pellegrini and Danielle Forrest, Ridgecrest Durneval LLP, dated January 8, 2026, reiterating GenomeDx's position on each of the thirty-four (34) challenged privilege log entries and requesting production by January 20, 2026.

Exhibit C: Response letter from Danielle Forrest, Ridgecrest Durneval LLP, to Peter Vassiliev, Calderwood & Harkness LLP, dated January 15, 2026, refusing to produce the thirty-four (34) challenged documents and asserting attorney-client privilege and common-interest doctrine as grounds for withholding.

Exhibit D: Excerpts from Helios Precision Diagnostics, Inc.'s Privilege Log, listing the thirty-four (34) challenged documents with privilege log entry numbers, dates, authors/recipients, document descriptions, and privilege bases asserted.

Exhibit E: Relevant excerpts from Helios Precision Diagnostics, Inc.'s Responses and Objections to Plaintiff's First Set of Requests for Production of Documents (Nos. 22, 23, and 31), demonstrating the scope of Helios's withholdings and the general and specific objections asserted therein.

Exhibit F: Stipulated Protective Order entered December 18, 2025 (Dkt. No. 74).

X. CONCLUSION

54. For the reasons set forth above, I respectfully submit this declaration in support of GenomeDx's Motion to Compel the production of the thirty-four (34) documents that Helios has improperly withheld on the basis of attorney-client privilege and/or work-product protection. The challenged documents are primarily business documents whose dominant purpose is commercial decision-making, not the seeking or rendering of legal advice. Many of the challenged documents were shared with third-party investors outside the scope of any attorney-client relationship, thereby waiving any privilege that might have attached. Helios's invocation of the common-interest doctrine is without merit because the investors' interest is financial and commercial, not legal. The documents are directly relevant to GenomeDx's claims of willful infringement, damages, and Helios's state of mind, and the Stipulated Protective Order provides adequate safeguards for any sensitive information they may contain. The thirty-four (34) challenged documents should be produced subject to the Stipulated Protective Order.

55. I declare under penalty of perjury under the laws of the United States of America, pursuant to 28 U.S.C. § 1746, that the foregoing is true and correct.

Executed in San Francisco, California on January 30, 2026.

________________________________________

Peter Vassiliev Lead Associate Calderwood & Harkness LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 882-6300 Facsimile: (415) 882-6301

Email: pvassiliev@calderwoodharkness.com

Attorney for Plaintiff Genome Dx Therapeutics Inc.

CERTIFICATE OF SERVICE

I, Peter Vassiliev, hereby certify that on January 30, 2026, I caused a true and correct copy of the foregoing Declaration of Peter Vassiliev in Support of Plaintiff's Motion to Compel Production of Documents Responsive to Requests for Production Nos. 22, 23, and 31, together with all exhibits attached thereto (Exhibits A through F), to be served on all counsel of record for Defendant Helios Precision Diagnostics, Inc. via the Court's CM/ECF electronic filing system, which will send notification of such filing to the following:

Marcus Pellegrini, Esq. Danielle Forrest, Esq. Owen Chu, Esq. Ridgecrest Durneval LLP One Federal Street, Suite 3400 Boston, Massachusetts 02110 Telephone: (617) 554-2000

Email: mpellegrini@ridgecrestkirkpatrick.com

Email: dforrest@ridgecrestkirkpatrick.com

Email: 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. Jessica W. Langston
v.	Referred to Magistrate Judge

Hon. David R. Cabrera

HELIOS PRECISION DIAGNOSTICS, INC.,

Defendant.

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION
DECLARATION OF PETER VASSILIEV IN SUPPORT OF PLAINTIFF'S MOTION TO COMPEL PRODUCTION OF DOCUMENTS RESPONSIVE TO REQUESTS FOR PRODUCTION NOS. 22, 23, AND 31
Date: January 30, 2026
I, Peter Vassiliev, hereby declare under penalty of perjury under 28 U.S.C. § 1746 as follows:
I. INTRODUCTION AND DECLARANT IDENTIFICATION
1.  I am an attorney duly admitted to practice before the United States District Court for the Northern District of California and a member in good standing of the California State Bar (Bar No. 318742). I am a Lead Associate in the intellectual Property Litigation group at Calderwood & Harkness LLP, located at 555 Mission Street, Suite 3100, San Francisco, California 94105. I hold a Doctor of Philosophy degree in Bioinformatics from the University of California, San Diego, which I received in 2017. I am a seventh-year associate at Calderwood & Harkness LLP.
2.  I am a member of the litigation team representing Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx" or "Plaintiff") in the above-captioned patent infringement action, working under the supervision of Catherine Bloom, the Responsible Partner for this engagement. In this capacity, I have been actively involved in all aspects of fact discovery in this case, including the drafting and service of Plaintiff's First Set of Requests for Production of Documents, the review and analysis of Defendant Helios Precision Diagnostics, Inc.'s ("Helios" or "Defendant") responses and production thereto, the review and analysis of Helios's privilege log, and the meet-and-confer process with defense counsel concerning the discovery disputes at issue in the pending motion.
3.  I have personal knowledge of the facts set forth in this declaration and, if called as a witness, I could and would competently testify to them.
4.  I submit this declaration in support of Plaintiff GenomeDx's Motion to Compel Production of Documents Responsive to Plaintiff's First Set of Requests for Production of Documents, Nos. 22, 23, and 31 (the "Motion to Compel"). Specifically, GenomeDx seeks the production of thirty-four (34) documents that Defendant Helios has improperly withheld on the basis of attorney-client privilege and/or work-product protection, as reflected in Helios's privilege log.
II. BACKGROUND OF THE LITIGATION
5.  GenomeDx filed this patent infringement action against Helios on March 28, 2025. The Complaint asserts claims of infringement of three United States patents: U.S. Patent No. 10,438,271 (the "'271 Patent"), U.S. Patent No. 11,204,893 (the "'893 Patent"), and U.S. Patent No. 11,891,647 (the "'647 Patent") (collectively, the "Asserted Patents"). Each of the Asserted Patents is owned by GenomeDx and covers proprietary genomic-classifier methods for prostate cancer prognosis, including novel combinations of gene-expression signatures, algorithmic classification methods, and clinical-decision-support outputs that enable physicians to assess the risk of metastatic disease following prostatectomy.
6.  GenomeDx alleges that Helios's ProstaSignal™ Genomic Classifier (the "Accused Product"), which was commercially launched on or about October 7, 2024, infringes asserted claims of all three of the Asserted Patents. The ProstaSignal™ Genomic Classifier is a laboratory-developed test that analyzes gene-expression patterns in prostate tumor tissue to generate a risk score used in clinical decision-making regarding adjuvant treatment following radical prostatectomy — functionality that is covered by the claims of the Asserted Patents.
7.  On May 12, 2025, Helios filed its Answer and Counterclaims. Helios's Answer asserts affirmative defenses of invalidity under 35 U.S.C. §§ 101 (patent-ineligible subject matter), 102 (anticipation), and 103 (obviousness), as well as defenses of non-infringement and unenforceability. Helios's Counterclaims seek declaratory judgments of invalidity and non-infringement with respect to each of the three Asserted Patents.
8.  On January 13, 2026, the Court (Hon. Jessica W. Langston, presiding) issued an Order denying Helios's Motion to Dismiss Counts II and III of GenomeDx's Complaint under 35 U.S.C. § 101, finding that GenomeDx had adequately pleaded that the claimed inventions were directed to patent-eligible subject matter. The Court's Order confirmed that the infringement claims asserted against the '893 Patent and the '647 Patent will proceed to discovery and, ultimately, trial.
9.  The Scheduling Order in this case was issued on June 18, 2025, by Judge Langston. Among other deadlines, the Scheduling Order establishes a fact discovery close date of March 6, 2026. Given that the instant motion concerns documents that are directly relevant to GenomeDx's claims of willful infringement, damages, and Helios's state of mind regarding GenomeDx's patent rights, the timely resolution of this discovery dispute is essential to ensure that GenomeDx can complete its fact-discovery program within the time allotted by the Scheduling Order.
III. THE RELEVANT REQUESTS FOR PRODUCTION
A. Request for Production No. 22
10.  Request for Production No. 22 ("RFP No. 22"), as set forth in Plaintiff's First Set of Requests for Production of Documents, requests the following:
All pre-launch business plans, strategic plans, and market analyses relating to the ProstaSignal™ Genomic Classifier that reference, discuss, or analyze (a) U.S. Patent Nos. 10,438,271; 11,204,893; and/or 11,891,647; (b) GenomeDx's Decipher® test; or (c) GenomeDx's intellectual property portfolio.
11.  RFP No. 22 is directly relevant to multiple issues in this case, including: (a) Helios's knowledge of GenomeDx's patents prior to the commercial launch of the ProstaSignal™ Genomic Classifier, which bears on GenomeDx's claim of willful infringement and the potential for enhanced damages under 35 U.S.C. § 284; (b) Helios's competitive positioning of the ProstaSignal™ product relative to GenomeDx's Decipher® test, which bears on market share, lost profits, and the reasonable-royalty analysis; and (c) Helios's assessment of GenomeDx's intellectual property as a factor in its commercial strategy, which is relevant to both liability and damages.
B. Request for Production No. 23
12.  Request for Production No. 23 ("RFP No. 23") requests the following:
All board of directors presentations, board minutes, and board-level reports relating to the ProstaSignal™ Genomic Classifier that reference or discuss (a) Genome Dx Therapeutics Inc.; (b) GenomeDx's Decipher® test; or (c) any freedom-to-operate analysis, patent clearance analysis, or assessment of intellectual property risk.
13.  RFP No. 23 is directly relevant to Helios's corporate state of mind, its awareness of GenomeDx's patent rights at the board level, and the degree to which Helios's board of directors considered and evaluated the risk of patent infringement before approving the commercial launch of the ProstaSignal™ Genomic Classifier. Such evidence is highly probative of willfulness, as board-level knowledge and decision-making reflects the deliberate, considered actions of the company's highest governing body.
C. Request for Production No. 31
14.  Request for Production No. 31 ("RFP No. 31") requests the following:
All investor presentations, investor memoranda, and communications with investors — including but not limited to Corinth Ventures Fund III, LP and Aether Life Sciences Partners — concerning the ProstaSignal™ Genomic Classifier that reference or discuss (a) GenomeDx's patents (U.S. Patent Nos. 10,438,271; 11,204,893; and/or 11,891,647); (b) GenomeDx's Decipher® test; (c) the competitive landscape for genomic classifiers in prostate cancer prognosis; or (d) intellectual property risks.
15.  RFP No. 31 is relevant to Helios's own assessment of patent risk, including how Helios characterized that risk to sophisticated investors who were asked to fund the development and commercialization of the ProstaSignal™ product. These materials are also relevant to GenomeDx's damages theories, as investor presentations and memoranda frequently contain detailed market projections, revenue forecasts, pricing assumptions, and competitive analyses that reflect the commercial expectations and market value of the accused product.
IV. HELIOS'S RESPONSES AND PRODUCTION
A. Initial Responses
16.  GenomeDx served its First Set of Requests for Production of Documents (Nos. 1–47) on Helios on January 27, 2025. Helios served its written responses and objections to the Requests for Production on a rolling basis, beginning with certain categories of responsive documents and continuing through late fall 2025.
17.  In response to RFP Nos. 22, 23, and 31, Helios produced a total of 1,247 documents, consisting primarily of internal marketing materials, publicly available investor presentations, high-level business summaries, and communications among Helios employees that do not reference GenomeDx's patents or intellectual property in any meaningful detail. While GenomeDx appreciates the documents that have been produced, the production is materially incomplete because Helios has withheld eighty-three (83) documents on the basis of attorney-client privilege and/or work-product protection, as reflected in the privilege log that Helios produced.
B. The Privilege Log
18.  Helios's privilege log identifies eighty-three (83) documents withheld across all categories of Requests for Production, asserting attorney-client privilege, work-product protection, or both as the basis for withholding each document.
19.  After careful review and analysis of the privilege log entries, GenomeDx challenges thirty-four (34) of the eighty-three (83) withheld documents as improperly withheld. GenomeDx does not challenge the remaining forty-nine (49) entries on the privilege log, which appear to involve documents whose dominant purpose is the seeking or rendering of legal advice and which were not shared with third parties outside the scope of the attorney-client relationship.
20.  The thirty-four (34) challenged documents span the following categories, as described in Helios's privilege log:
(a) Twelve (12) documents described as board presentations or board-level memoranda prepared for or presented to Helios's board of directors, with subject lines such as "Q2 2024 Board Presentation — ProstaSignal™ Update," "Board Memo: Competitive Landscape and Market Entry Strategy," and "ProstaSignal™ Launch Readiness — Board Summary";
(b) Nine (9) documents described as investor presentations or investor update materials that were shared with Corinth Ventures Fund III, LP ("Corinth Ventures") and/or Aether Life Sciences Partners ("Aether"), with subject lines such as "Corinth Ventures Quarterly Update — ProstaSignal™ Development and Commercialization," "Investor Deck — Series B Expansion Strategy," and "Aether/Corinth Update: ProstaSignal™ Clinical Validation and Market Opportunity";
(c) Eight (8) documents described as internal business plans or strategy memoranda with references to legal advice, with subject lines such as "ProstaSignal™ Market Launch Strategy — Confidential," "Competitive Analysis: Decipher® vs. ProstaSignal™," and "Five-Year Revenue Projection Model — ProstaSignal™ Platform";
(d) Five (5) documents described as email communications between Helios executives — specifically Dr. Nathan Ashford (Chief Executive Officer), Dr. Elaine Kossack (Chief Scientific Officer), and Derek Mallinson (Vice President of Commercial Operations) — and Sara Whitmore (General Counsel), where those emails were also sent to, copied to, or shared with non-legal business personnel within Helios and/or with representatives of Corinth Ventures and/or Aether.
21.  A true and correct copy of the relevant portions of Helios's privilege log identifying the thirty-four (34) challenged documents, including each document's privilege log entry number, date, author(s), recipient(s), document description, and the privilege basis asserted, is attached hereto as Exhibit D and incorporated herein by reference.
V. MEET-AND-CONFER EFFORTS
A. Initial Correspondence — December 12, 2025
22.  After reviewing the privilege log entries that accompanied Helios's early rolling productions, I sent a detailed letter dated December 12, 2025 to Marcus Pellegrini, Lead Partner at Ridgecrest Durneval LLP, One Federal Street, Suite 3400, Boston, Massachusetts 02110, counsel of record for Defendant Helios. In that letter, I identified GenomeDx's specific concerns regarding thirty-four (34) privilege log entries and requested that defense counsel meet and confer in good faith regarding those entries.
23.  In the December 12, 2025 letter, I explained that many of the withheld documents appeared, based on their privilege log descriptions, to be primarily business documents — including board presentations, investor materials, and strategic plans — whose dominant purpose was commercial decision-making, not the seeking or rendering of legal advice. I noted that the inclusion of Sara Whitmore (General Counsel) as a copy recipient or contributor did not, standing alone, transform an otherwise business communication into a privileged legal communication. I further observed that documents shared with third-party investors, including Corinth Ventures Fund III, LP and Aether Life Sciences Partners, appeared to have been disclosed outside the scope of any attorney-client relationship, thereby waiving any privilege that might otherwise have attached. I requested that Helios re-evaluate its privilege assertions and produce the challenged documents, or alternatively agree to a telephonic meet-and-confer to discuss the issues in greater detail.
24.  A true and correct copy of my December 12, 2025 letter to Marcus Pellegrini is attached hereto as Exhibit A and incorporated herein by reference.
B. Telephone Conference — December 19, 2025
25.  On December 19, 2025, I participated in a telephonic meet-and-confer conference with Catherine Bloom, Responsible Partner at Calderwood & Harkness LLP. Representing Helios on the call were Marcus Pellegrini, Lead Partner, and Danielle Forrest, Senior Associate, both of Ridgecrest Durneval LLP.
26.  During the approximately forty-five-minute telephone conference, Mr. Pellegrini and Ms. Forrest took the position that all thirty-four (34) of the challenged documents were protected by attorney-client privilege because Sara Whitmore, Helios's General Counsel, was either copied on, contributed to, or otherwise participated in the creation or dissemination of each document. Mr. Pellegrini stated that Ms. Whitmore's involvement in each communication was in her capacity as legal counsel and that her contributions reflected legal advice regarding freedom-to-operate, patent clearance, and intellectual property risk management.
27.  Ms. Bloom and I responded to defense counsel's position with several arguments. First, we explained that the mere inclusion of in-house counsel on a communication or document does not establish attorney-client privilege, particularly where the dominant purpose of the communication was business rather than legal in nature. We cited applicable Ninth Circuit authority for the proposition that the privilege protects only those communications made for the purpose of seeking or providing legal advice, and that where in-house counsel performs a business function, the privilege does not attach. Second, we argued that documents shared with third-party investors — specifically Corinth Ventures Fund III, LP and Aether Life Sciences Partners — destroyed any privilege that might otherwise have attached, because those entities are not within the attorney-client relationship and their receipt of allegedly privileged materials constitutes voluntary disclosure to third parties.
28.  Mr. Pellegrini responded that Helios's position was that the common-interest doctrine protected communications shared with its investors because Corinth Ventures and Aether had a shared legal interest in Helios's patent risk management. Ms. Bloom and I disagreed, noting that an investor's financial interest in the success of a portfolio company is a business interest, not a common legal interest, and that the common-interest doctrine requires a shared interest in pending or anticipated litigation or a common legal strategy, not merely a shared desire for the company's commercial success.
29.  After extensive discussion, the parties were unable to reach agreement on any of the thirty-four (34) challenged documents. Mr. Pellegrini stated that Helios would maintain its privilege assertions in full. I contemporaneously memorialized the substance of the December 19, 2025 call in my internal notes.
C. Follow-Up Letter — January 8, 2026
30.  On January 8, 2026, I sent a follow-up letter to Marcus Pellegrini and Danielle Forrest at Ridgecrest Durneval LLP. In that letter, I reiterated GenomeDx's position that the thirty-four (34) challenged documents had been improperly withheld, and I identified each document by its privilege log entry number, date, and description. I requested that Helios produce the documents by January 20, 2026, to allow sufficient time for review before the close of fact discovery on March 6, 2026.
31.  The January 8, 2026 letter also noted that the Stipulated Protective Order entered on December 18, 2025 by Judge Langston (Dkt. No. 74) — which establishes two tiers of protection, "Confidential" and "Highly Confidential — Attorneys' Eyes Only" — provides adequate safeguards for any sensitive business information contained in the challenged documents. I emphasized that Helios could designate the produced documents at either tier of protection, thereby ensuring that the documents would be used solely for purposes of this litigation and would not be disclosed publicly or to unauthorized individuals.
32.  A true and correct copy of my January 8, 2026 letter to Marcus Pellegrini and Danielle Forrest is attached hereto as Exhibit B and incorporated herein by reference.
D. Helios's Response — January 15, 2026
33.  On January 15, 2026, Danielle Forrest of Ridgecrest Durneval LLP responded on behalf of Helios by letter addressed to me. Ms. Forrest's letter refused to produce any of the thirty-four (34) challenged documents.
34.  Ms. Forrest's letter asserted three grounds for Helios's continued withholding of the documents:
(1) First, Ms. Forrest stated that each of the thirty-four documents reflects or incorporates legal advice from General Counsel Sara Whitmore regarding freedom-to-operate and patent clearance, and that accordingly each document is protected in its entirety by the attorney-client privilege;
(2) Second, Ms. Forrest argued that sharing the documents with members of Helios's board of directors and with Helios's investors does not waive privilege because those communications were made in furtherance of obtaining legal advice for corporate decision-making, and that the recipients were necessary participants in the corporate decision-making process that required legal input;
(3) Third, Ms. Forrest asserted that investor communications are protected under the common-interest doctrine because Corinth Ventures Fund III, LP and Aether Life Sciences Partners have a shared legal interest in Helios's patent risk management, and that the sharing of documents with those entities was undertaken pursuant to an implicit common-interest arrangement.
35.  A true and correct copy of Danielle Forrest's January 15, 2026 response letter is attached hereto as Exhibit C and incorporated herein by reference.
E. Exhaustion of Meet-and-Confer
36.  Despite GenomeDx's good-faith efforts to resolve this discovery dispute without Court intervention, the parties remain at an impasse regarding all thirty-four (34) challenged documents. Over the course of approximately seven weeks — from December 12, 2025 through January 15, 2026 — the parties exchanged three written communications (December 12, 2025; January 8, 2026; and January 15, 2026) and participated in one telephonic meet-and-confer conference (December 19, 2025). At each stage, GenomeDx identified its specific concerns with particularity, provided legal authority supporting its position, and proposed a resolution. At each stage, Helios declined to produce any of the challenged documents or to offer any compromise.
37.  Consistent with Civil Local Rule 37-1 of the Northern District of California and the Northern District of California's Guidelines for discovery, GenomeDx has exhausted its meet-and-confer obligations before filing the instant Motion to Compel.
VI. ANALYSIS OF THE CHALLENGED DOCUMENTS
A. The 34 Challenged Documents Are Primarily Business Documents
38.  Based on my review of the privilege log descriptions provided by Helios, the thirty-four (34) challenged documents are board presentations, investor materials, business plans, and strategy memoranda whose dominant purpose is commercial decision-making — not the seeking or rendering of legal advice. The privilege log descriptions themselves reveal the business character of these documents. For example, the log entries reference subjects such as "ProstaSignal™ market launch strategy," "competitive positioning vs. Decipher® test," "projected revenue and market share analysis," "investor update on product development timeline," "Series B expansion strategy," "five-year revenue projection model," and "launch readiness — board summary." These are quintessentially business topics that relate to Helios's commercial operations, marketing strategy, financial projections, and investor relations.
39.  While some of these documents may contain incidental references to legal topics or may have been shared with or reviewed by Sara Whitmore in her capacity as General Counsel, the inclusion of in-house counsel on a communication or the presence of incidental legal references does not transform a business document into a privileged legal communication. Under Ninth Circuit law, the attorney-client privilege protects only those communications whose primary purpose is the seeking or providing of legal advice. Where a document is primarily a business communication — as the privilege log descriptions of the thirty-four challenged documents indicate — the mere fact that an attorney was involved does not render the document privileged.
40.  In the context of in-house counsel, this distinction is particularly important. In-house counsel frequently perform dual roles within corporations, serving both as legal advisors and as business participants in corporate strategy, product development, and operational decision-making. When in-house counsel acts in a business capacity — for example, by contributing to market strategy presentations, participating in investor updates, or reviewing business plans for non-legal purposes — those activities do not generate attorney-client privilege. The burden is on the party asserting privilege to demonstrate that the communication was made for the primary purpose of seeking or providing legal advice, and the privilege log descriptions provided by Helios fail to carry that burden with respect to any of the thirty-four challenged documents.
B. Documents Shared with Third-Party Investors
41.  At least nine (9) of the thirty-four (34) challenged documents were shared with Corinth Ventures Fund III, LP ("Corinth Ventures") and/or Aether Life Sciences Partners ("Aether"). Corinth Ventures is Helios's majority investor, holding 58.7% of Helios's equity, and is managed by Priya Chandrasekaran, with offices at 399 Boylston Street, Suite 1100, Boston, Massachusetts 02116. Aether is a Series A investor holding approximately 11.0% of Helios's equity. Both entities are sophisticated venture-capital and life-sciences investment firms that have a financial — not a legal — interest in Helios's commercial success.
42.  It is well established that voluntary disclosure of otherwise privileged communications to third parties who are outside the attorney-client relationship constitutes a waiver of attorney-client privilege. Helios's disclosure of these nine (9) documents to Corinth Ventures and Aether destroyed any privilege that might have attached to those communications. Neither Corinth Ventures nor Aether is Helios's attorney, and neither entity falls within the scope of the attorney-client relationship between Helios and its General Counsel, Sara Whitmore, or between Helios and its outside counsel at Ridgecrest Durneval LLP.
43.  Helios's assertion that the common-interest doctrine protects these communications is without merit. The common-interest doctrine (sometimes referred to as the "joint defense" or "community of interest" doctrine) is a narrow exception to the general rule that disclosure to third parties waives privilege. To invoke the common-interest doctrine, the party asserting privilege must demonstrate that the parties share a common legal interest — not merely a common business, financial, or commercial interest — and that the communications were made in furtherance of a joint legal strategy or in connection with pending or anticipated litigation.
44.  An investor's interest in the financial success of its portfolio company is a quintessential business interest, not a common legal interest. Corinth Ventures and Aether are not co-defendants in this litigation, are not parties to any related legal proceeding, and are not engaged in a joint legal defense strategy with Helios. Their interest in Helios's patent risk management is derivative of and subordinate to their financial interest in the return on their investment. Under established authority, this type of shared financial or commercial interest is insufficient to invoke the common-interest doctrine. Helios has not provided, and cannot provide, evidence that Corinth Ventures or Aether entered into any written or oral common-interest agreement with Helios, or that the documents were shared pursuant to such an agreement for the purpose of advancing a common legal strategy.
C. Board Presentations with Mixed Business and Legal Content
45.  Twelve (12) of the thirty-four (34) challenged documents are described in the privilege log as board presentations or board-level memoranda. To the extent that any of these documents contain mixed business and legal content, the business portions of those documents are not protected by attorney-client privilege. The privilege does not provide blanket protection for an entire document merely because some portion of the document references or incorporates legal advice. Rather, only those specific communications made for the purpose of seeking or providing legal advice are privileged, and the remaining business content must be produced.
46.  The composition of Helios's board of directors further undermines Helios's privilege assertions with respect to these twelve (12) board presentations. Based on publicly available information and Helios's own filings in this case, Helios's board includes representatives of Corinth Ventures, including at least one board seat occupied by a Corinth Ventures designee. The sharing of allegedly privileged documents with a board that includes investor representatives further extends the disclosure beyond the bounds of any attorney-client privilege, without an adequate showing that the common-interest doctrine applies, for the reasons set forth above.
D. Internal Emails Shared Beyond Counsel
47.  Five (5) of the thirty-four (34) challenged documents are described as email communications between Helios executives — specifically Dr. Nathan Ashford (Chief Executive Officer), Dr. Elaine Kossack (Chief Scientific Officer), and Derek Mallinson (Vice President of Commercial Operations) — and Sara Whitmore (General Counsel), where those emails were also sent to or shared with non-legal business personnel within Helios and, in some instances, with representatives of Corinth Ventures and/or Aether. To the extent that these email communications reflect primarily business discussion — such as commercial strategy, competitive positioning, or market analysis — with incidental legal input from Ms. Whitmore, those communications are not privileged. The broad distribution of these emails to non-legal personnel and, in some cases, to third-party investor representatives, confirms that the dominant purpose of the communications was business, not legal.
VII. RELEVANCE OF THE 34 CHALLENGED DOCUMENTS
48.  The thirty-four (34) withheld documents are directly relevant to GenomeDx's claims and damages theories in this action. Specifically:
(a) Willful Infringement. Board presentations and investor materials discussing GenomeDx's patents, the Decipher® test, or freedom-to-operate analyses are probative of Helios's pre-launch knowledge of GenomeDx's patent rights and the deliberateness of Helios's decision to launch the ProstaSignal™ Genomic Classifier notwithstanding those rights. Evidence that Helios's board of directors and investor base were aware of GenomeDx's intellectual property and the risk of infringement is highly relevant to GenomeDx's claim of willful infringement and to the potential for enhanced damages under 35 U.S.C. § 284. The Federal Circuit has recognized that evidence of pre-suit knowledge of the asserted patents, and the accused infringer's assessment of infringement risk, is among the most probative evidence on the question of willfulness.
(b) Damages. Business plans and market analyses showing Helios's projected revenue from the ProstaSignal™ Genomic Classifier, its pricing strategy (including the average reimbursement rate of approximately $3,820 per test), and its competitive positioning against GenomeDx's Decipher® test are directly relevant to GenomeDx's lost-profits analysis and reasonable-royalty calculation. Investor presentations and memoranda, in particular, frequently contain detailed financial projections and market-share assumptions that reflect the commercial value and anticipated commercial success of the accused product. This information is essential to determining the appropriate measure of damages.
(c) Infringement State of Mind. Documents showing Helios's awareness of the significant overlap between the ProstaSignal™ Genomic Classifier and GenomeDx's patented gene set — specifically, the nineteen-of-twenty-four gene overlap between ProstaSignal™ and the gene signatures claimed in GenomeDx's patents — and any discussions about designing around GenomeDx's patents, are highly probative of infringement and of Helios's knowledge and intent. Such documents may reveal that Helios was aware that its product substantially overlapped with GenomeDx's patented technology and nevertheless proceeded with commercialization, which is directly relevant to both liability and enhanced damages.
49.  The importance of these documents to GenomeDx's case cannot be overstated. Willful infringement, damages, and the accused infringer's state of mind are among the central issues in this patent infringement action, and the thirty-four (34) challenged documents — by Helios's own privilege log descriptions — are squarely directed to those issues. Helios should not be permitted to use overbroad and unsupported privilege assertions to shield from discovery the very documents that are most probative of its knowledge, intent, and commercial strategy regarding GenomeDx's patented technology.
VIII. THE PROTECTIVE ORDER PROVIDES ADEQUATE SAFEGUARDS
50.  On December 18, 2025, the Court entered the parties' Stipulated Protective Order (Dkt. No. 74), which establishes two tiers of confidentiality protection: "Confidential" and "Highly Confidential — Attorneys' Eyes Only." The Stipulated Protective Order was the product of good-faith negotiations between Calderwood & Harkness LLP and Ridgecrest Durneval LLP, following a meet-and-confer conference held on December 5, 2025.
51.  The Stipulated Protective Order provides robust safeguards against the public disclosure or misuse of sensitive business information. Documents designated as "Confidential" may be viewed by a defined group of individuals, including outside counsel, in-house counsel, experts, and certain litigation support personnel. Documents designated as "Highly Confidential — Attorneys' Eyes Only" are subject to even more restrictive access limitations, permitting review only by outside counsel, retained experts, and specifically designated litigation support staff. The Protective Order prohibits the use of designated materials for any purpose other than this litigation and imposes obligations of return or destruction upon the conclusion of the case.
52.  Helios may designate any or all of the thirty-four (34) challenged documents at either tier of the Stipulated Protective Order, thereby ensuring that any sensitive business information contained in those documents is adequately protected from public disclosure, competitive harm, or any other misuse. The existence of the Stipulated Protective Order undermines any argument by Helios that production of the challenged documents would cause competitive harm or prejudice. The Court's Protective Order was designed precisely to address such concerns and to facilitate the full and fair exchange of relevant discovery materials while safeguarding legitimate confidentiality interests.
IX. LIST OF EXHIBITS
53.  The following exhibits are attached hereto and incorporated by reference into this declaration:
Exhibit A: Letter from Peter Vassiliev, Calderwood & Harkness LLP, to Marcus Pellegrini, Ridgecrest Durneval LLP, dated December 12, 2025, identifying the thirty-four (34) challenged privilege log entries and requesting a meet-and-confer conference.
Exhibit B: Follow-up letter from Peter Vassiliev, Calderwood & Harkness LLP, to Marcus Pellegrini and Danielle Forrest, Ridgecrest Durneval LLP, dated January 8, 2026, reiterating GenomeDx's position on each of the thirty-four (34) challenged privilege log entries and requesting production by January 20, 2026.
Exhibit C: Response letter from Danielle Forrest, Ridgecrest Durneval LLP, to Peter Vassiliev, Calderwood & Harkness LLP, dated January 15, 2026, refusing to produce the thirty-four (34) challenged documents and asserting attorney-client privilege and common-interest doctrine as grounds for withholding.
Exhibit D: Excerpts from Helios Precision Diagnostics, Inc.'s Privilege Log, listing the thirty-four (34) challenged documents with privilege log entry numbers, dates, authors/recipients, document descriptions, and privilege bases asserted.
Exhibit E: Relevant excerpts from Helios Precision Diagnostics, Inc.'s Responses and Objections to Plaintiff's First Set of Requests for Production of Documents (Nos. 22, 23, and 31), demonstrating the scope of Helios's withholdings and the general and specific objections asserted therein.
Exhibit F: Stipulated Protective Order entered December 18, 2025 (Dkt. No. 74).
X. CONCLUSION
54.  For the reasons set forth above, I respectfully submit this declaration in support of GenomeDx's Motion to Compel the production of the thirty-four (34) documents that Helios has improperly withheld on the basis of attorney-client privilege and/or work-product protection. The challenged documents are primarily business documents whose dominant purpose is commercial decision-making, not the seeking or rendering of legal advice. Many of the challenged documents were shared with third-party investors outside the scope of any attorney-client relationship, thereby waiving any privilege that might have attached. Helios's invocation of the common-interest doctrine is without merit because the investors' interest is financial and commercial, not legal. The documents are directly relevant to GenomeDx's claims of willful infringement, damages, and Helios's state of mind, and the Stipulated Protective Order provides adequate safeguards for any sensitive information they may contain. The thirty-four (34) challenged documents should be produced subject to the Stipulated Protective Order.
55.  I declare under penalty of perjury under the laws of the United States of America, pursuant to 28 U.S.C. § 1746, that the foregoing is true and correct.
Executed in San Francisco, California on January 30, 2026.
________________________________________
Peter Vassiliev Lead Associate Calderwood & Harkness LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 882-6300 Facsimile: (415) 882-6301
Email: pvassiliev@calderwoodharkness.com
Attorney for Plaintiff Genome Dx Therapeutics Inc.
CERTIFICATE OF SERVICE
I, Peter Vassiliev, hereby certify that on January 30, 2026, I caused a true and correct copy of the foregoing Declaration of Peter Vassiliev in Support of Plaintiff's Motion to Compel Production of Documents Responsive to Requests for Production Nos. 22, 23, and 31, together with all exhibits attached thereto (Exhibits A through F), to be served on all counsel of record for Defendant Helios Precision Diagnostics, Inc. via the Court's CM/ECF electronic filing system, which will send notification of such filing to the following:
Marcus Pellegrini, Esq. Danielle Forrest, Esq. Owen Chu, Esq. Ridgecrest Durneval LLP One Federal Street, Suite 3400 Boston, Massachusetts 02110 Telephone: (617) 554-2000
Email: mpellegrini@ridgecrestkirkpatrick.com
Email: dforrest@ridgecrestkirkpatrick.com
Email: 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. Jessica W. Langston
v. | Referred to Magistrate Judge
Hon. David R. Cabrera
HELIOS PRECISION DIAGNOSTICS, INC., | (Discovery Disputes)
<!-- indent:2 -->Defendant.<!-- /indent -->