MEMORANDUM
PRIVILEGED AND CONFIDENTIAL — ATTORNEY WORK PRODUCT
FROM: Peter Vassiliev and Wendy Schultz
TO: Catherine Bloom, Responsible Partner
DATE: February 2026
RE: discovery Strategy and Deposition Plan — Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc., Case No. 3:25-cv-01847-JWL (N.D. Cal.)
CLIENT: Genome Dx Therapeutics Inc.
MATTER: Patent Infringement — U.S. Patent Nos. 10,438,271; 11,204,893; 11,891,647
This memorandum is protected by the attorney-client privilege and the work product doctrine. It is intended solely for the use of the addressee and other authorized members of the litigation team. It should not be disclosed to any third party without the express written consent of Catherine Bloom or the client. Any inadvertent disclosure does not constitute a waiver of any applicable privilege.
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I. Executive Summary
The purpose of this memorandum is to set forth the litigation team's recommended discovery strategy and deposition plan for the remaining weeks of fact discovery in Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc., Case No. 3:25-cv-01847-JWL (N.D. Cal.). Fact discovery closes on March 6, 2026, and there is substantial work remaining across multiple workstreams. This memorandum consolidates the team's assessment of the current discovery posture, identifies the highest-priority depositions and document requests, and proposes a concrete plan of action to ensure we maximize the evidentiary record before the close of fact discovery.
Current Posture. The Honorable Jessica W. Langston denied Helios Precision Diagnostics, Inc.'s ("Helios") Motion to Dismiss on January 13, 2026, clearing the way for full fact discovery. The parties are now in active fact discovery. Document production is substantially underway on both sides, although significant disputes remain regarding 34 documents withheld by Helios on privilege grounds. Depositions have not yet commenced. GenomeDx's 30(b)(6) deposition notice to Helios was served on February 28, 2026, and Helios served its own 30(b)(6) notice on GenomeDx on February 24, 2026 designating 12 topics for corporate testimony. The compressed timeline between now and the March 6, 2026 fact discovery deadline requires immediate, coordinated action across all workstreams.
Key Action Items. We have identified six critical action items that must be executed in the coming weeks:
1. Complete document review and pursue outstanding productions. The team must finalize its review of the approximately 167,000 documents produced by Helios, identify gaps in production, and pursue supplemental productions where Helios's responses have been deficient. Simultaneously, GenomeDx must complete its own privilege review and finalize any outstanding production obligations.
2. Resolve the pending motion to compel before Magistrate Judge David R. Cabrera. GenomeDx's motion to compel production of 34 documents withheld by Helios on privilege grounds (relating to RFP Nos. 22, 23, and 31) was filed on January 30, 2026. A ruling is expected in late February or early March 2026. A favorable ruling would provide critical evidence of Helios's pre-launch awareness of GenomeDx's patent portfolio — directly relevant to willfulness and enhanced damages under 35 U.S.C. § 284.
3. Finalize and serve the third-party subpoena to Corinth Ventures Fund III, LP. A draft subpoena duces tecum has been prepared and must be reviewed, approved, and served promptly. Corinth Ventures is believed to hold investment memoranda, due diligence reports, and board observation materials that reference GenomeDx's patents and Helios's freedom-to-operate analysis. These materials could corroborate or supplement the 34 withheld documents at the center of the motion to compel.
4. Conduct five priority depositions of Helios personnel. The team has identified five depositions that are essential to building GenomeDx's case on infringement, willfulness, and damages. These depositions must be noticed, scheduled, prepared for, and conducted before the close of fact discovery — an extremely compressed timeline.
5. Prepare GenomeDx witnesses for defense depositions noticed by Helios. Helios's 30(b)(6) notice designates 12 topics for corporate testimony. GenomeDx must designate appropriate witnesses and prepare them thoroughly for deposition on topics including patent development, Decipher® test design, licensing history, financial data, and IP enforcement history.
6. Lay groundwork for expert engagement. Expert reports are due May 15, 2026. Deposition testimony and document productions from fact discovery will be the critical inputs for both the technical expert (Dr. Franklin Ogawa) and the damages expert (Dr. Louise Tremaine). Depositions should be structured to elicit testimony supporting expert opinions and to lock in factual predicates that will withstand Daubert scrutiny.
Budget Coordination. We will need to coordinate with billing partner Alan Ngo on the budget implications of the activities described in this memorandum. The estimated litigation budget through trial is $6.8M–$9.2M per the engagement letter dated March 12, 2025. The fact discovery phase is expected to be one of the most resource-intensive periods of the case, particularly given the compressed deposition schedule and the likelihood of contested third-party subpoena practice.
II. Current discovery Posture
A. Document Production Status
GenomeDx served 47 Requests for Production ("RFPs") on Helios on January 27, 2026. Helios served 52 RFPs on GenomeDx on the same date. Both parties have been engaged in rolling document productions since that time.
GenomeDx's Production. GenomeDx has produced approximately 218,000 documents from a total collection of approximately 482,000 documents (1.7 TB of data) drawn from 11 custodians. The custodians include the following key personnel:
• Dr. Rajan Mehta — Chief Technology Officer and named inventor on all three asserted patents (U.S. Patent Nos. 10,438,271; 11,204,893; 11,891,647);
• Dr. Kevin Ostrowski — Vice President of intellectual Property and named inventor on the '647 Patent;
• Dr. Miriam Langford — Chief Executive Officer;
• Victoria Sung — General Counsel;
• Thomas Brennan — Chief Financial Officer; and
• Seven additional R&D and commercial employees whose files contain relevant technical, scientific, and business documents.
Document review has been managed in accordance with GenomeDx's established review protocols, including the privilege review protocol set forth in Wendy Schultz's January 2026 Privilege Log Review Protocol Memorandum. That protocol establishes clear guidelines for the identification and logging of privileged documents, with particular attention to documents involving mixed business-and-legal content. Clawback protections are in place under the Stipulated Protective Order entered by Judge Langston on December 18, 2025, which incorporates Federal Rule of Evidence 502(d) protections against inadvertent waiver.
Helios's Production. Helios has produced approximately 167,000 documents to date. However, Helios has withheld 83 documents on privilege grounds, asserting attorney-client privilege and work product protection. GenomeDx has challenged 34 of the 83 withheld documents, contending that Helios's privilege assertions are insufficient or have been waived. This dispute is the subject of GenomeDx's motion to compel filed on January 30, 2026, discussed in greater detail in Section II.D below.
E-discovery Management. E-discovery for this matter is managed by Sandra Neville at Canfield Document Solutions LLC. The team is using the RevealIQ platform with TAR 2.0 (Technology-Assisted Review using predictive coding) to prioritize and categorize the large volumes of collected documents. TAR 2.0 enables continuous active learning, which has improved review efficiency and reduced the manual review burden. The estimated e-discovery cost through trial is $1.4M–$1.8M, depending on the volume of supplemental productions and the extent of any additional custodian collections that may be required.
The review workflow is proceeding on schedule. Sandra Neville's team has completed first-pass review of approximately 85% of the collected documents and is on track to finalize the remaining review within the next several weeks. Priority is being given to custodial files that are most likely to contain documents relevant to the infringement and willfulness theories, as well as documents that may be responsive to Helios's RFPs.
B. Written discovery Status
Interrogatories. GenomeDx served 15 interrogatories on Helios on February 10, 2026. Helios served 17 interrogatories on GenomeDx on the same date. GenomeDx's interrogatories to Helios target, among other things, the identity of persons involved in ProstaSignal™ development, the timeline of Helios's awareness of GenomeDx's patent portfolio, the factual basis for Helios's invalidity contentions, and the methodology underlying ProstaSignal™'s classifier algorithm.
GenomeDx's Responses to Helios's RFPs. GenomeDx's responses and objections to Helios's 52 RFPs were served on February 26, 2026. The responses include appropriate objections based on overbreadth, proportionality, and privilege, while making substantive rolling productions of responsive documents. Wendy Schultz reviewed and finalized the responses, ensuring consistency with GenomeDx's litigation positions and the terms of the Stipulated Protective Order.
GenomeDx's Responses to Helios's Interrogatories. GenomeDx's responses to Helios's 17 interrogatories are currently in draft form. We are targeting service of those responses in March 2026, which will be within the response period permitted by the Federal Rules. The draft responses are being coordinated with the relevant GenomeDx custodians to ensure factual accuracy, and they will require Catherine Bloom's review before service. Several interrogatories touch on sensitive areas — including the prosecution history of the asserted patents and the basis for GenomeDx's damages theories — and the responses must be carefully crafted to be fully responsive without making unnecessary concessions.
Helios's Responses to GenomeDx's Interrogatories. Helios's responses to GenomeDx's 15 interrogatories are due on or about March 2026. We will need to review those responses promptly upon receipt and assess whether any responses are deficient or evasive, as there may be limited time to pursue supplementation before the close of fact discovery.
C. Deposition Notices
Helios's 30(b)(6) Notice to GenomeDx. On February 24, 2026, Helios served a Rule 30(b)(6) deposition notice on GenomeDx designating 12 topics for corporate testimony. The notice is broad, covering topics ranging from patent development and prosecution to financial data and licensing history. GenomeDx must designate witnesses to testify on each topic and prepare those witnesses thoroughly. The recommended designees and preparation strategy are discussed in Section IV below.
GenomeDx's 30(b)(6) Notice to Helios. On February 28, 2026, GenomeDx served a Rule 30(b)(6) deposition notice on Helios designating 14 topics for corporate testimony. The topics are designed to elicit testimony on ProstaSignal™ development, the freedom-to-operate analysis, commercial launch planning, competitive positioning relative to GenomeDx, and Helios's financial data relevant to damages. Helios has not yet designated its witnesses for these topics.
Individual Deposition Notices for Helios Personnel. In addition to the 30(b)(6) deposition, GenomeDx intends to depose five individual Helios witnesses, as described in detail in Section III. Individual deposition notices for these witnesses need to be served promptly given the March 6, 2026 fact discovery deadline. The compressed timeline raises a threshold scheduling question: whether to seek a stipulated extension of the fact discovery deadline (discussed in Section VII.B) or to attempt to conduct all depositions on a compressed timeline before March 6, 2026.
Given the practical impossibility of scheduling, preparing for, and conducting five individual depositions plus a 30(b)(6) deposition within approximately one week, we strongly recommend pursuing a stipulated extension or, if necessary, a court-ordered extension. This issue is discussed further in Section VII.B below.
D. Pending Motion to Compel (RFP Nos. 22, 23, 31)
Background. GenomeDx filed a motion to compel production of 34 documents withheld by Helios on privilege grounds on January 30, 2026. The motion is pending before Magistrate Judge David R. Cabrera. The 34 challenged documents fall within three categories of documents requested by GenomeDx's RFP Nos. 22, 23, and 31:
• RFP No. 22: Pre-launch business plans for ProstaSignal™, including any documents referencing GenomeDx's patents, the Decipher® test, or GenomeDx's market position.
• RFP No. 23: Board presentations and investor materials prepared for Helios's board of directors or investors, including presentations to Corinth Ventures Fund III, LP, referencing GenomeDx's patents or the Decipher® test.
• RFP No. 31: Documents reflecting or relating to any freedom-to-operate analysis or patent clearance process conducted by Helios with respect to the '271, '893, or '647 Patents.
Helios withheld these 34 documents on the basis of attorney-client privilege and/or work product protection. However, GenomeDx's review of Helios's privilege log entries reveals that many of these documents appear to be predominantly business documents — strategic planning presentations, investor pitch decks, and competitive analyses — that were not created for the purpose of obtaining or providing legal advice. Moreover, several entries indicate that the documents were shared with non-lawyer business personnel and with investors at Corinth Ventures Fund III, LP, which would vitiate any claim of privilege.
GenomeDx's Supporting Papers. GenomeDx's motion is supported by a Memorandum of Points and Authorities and a Declaration of Peter Vassiliev. The declaration attaches the following exhibits:
• Meet-and-confer correspondence between GenomeDx's counsel and Marcus Pellegrini and Danielle Forrest at Ridgecrest Durneval LLP, Helios's litigation counsel, documenting the parties' unsuccessful efforts to resolve the dispute informally.
• Helios's privilege log entries for the 34 challenged documents, which GenomeDx contends are deficient in several respects.
• Excerpts from Helios's deficient responses to RFP Nos. 22, 23, and 31, demonstrating that Helios's objections are boilerplate and non-specific.
GenomeDx's Arguments. GenomeDx advances several arguments in support of the motion to compel:
First, the documents at issue were shared with Corinth Ventures Fund III, LP and other investors who are not members of the attorney-client relationship. Disclosure to third parties who are not within the attorney-client relationship generally destroys the privilege. Helios cannot maintain that communications shared with venture capital investors for purposes of fundraising, due diligence, or investor relations were made "for the purpose of obtaining or providing legal advice."
Second, even if certain documents contain embedded attorney-client communications, the predominantly business character of the documents — strategic plans, board presentations, investor pitch decks — means they were not created primarily for the purpose of seeking or providing legal advice. Under the "primary purpose" test applied in this Circuit, In re Grand Jury Subpoena, 599 F.3d 403 (9th Cir. 2010) (applying the primary-purpose test), documents that serve a dual business-and-legal purpose are not privileged unless the primary purpose was to obtain legal advice.
Third, sharing the documents with non-lawyer business personnel and investors constitutes waiver of any privilege that may have initially attached. The privilege log entries indicate that several documents were distributed to Helios's board of directors (which includes investor-appointed directors), to Corinth Ventures' representatives, and to other non-lawyer personnel within Helios who were not involved in seeking or receiving legal advice.
Helios's Anticipated Response. Based on the meet-and-confer discussions, we anticipate that Helios will argue:
• The documents reflect attorney-client communications that were embedded within business presentations at the direction of counsel, and the legal content is inseparable from the business content.
• Disclosure to Corinth Ventures Fund III, LP was made pursuant to a common-interest agreement or joint-defense arrangement, preserving the privilege. Helios may argue that Corinth, as a significant equity holder, shared a common legal interest in the potential patent infringement liability.
• The work product doctrine independently protects certain documents prepared in anticipation of litigation, even if they were shared with non-lawyers.
Briefing Status and Expected Ruling. Briefing on the motion to compel is ongoing. We expect a ruling from Magistrate Judge Cabrera in late February or early March 2026. Peter Vassiliev is monitoring the docket daily and will circulate any order immediately upon issuance.
Strategic Significance. The outcome of this motion is of considerable strategic importance to GenomeDx's case. The 34 withheld documents are expected to contain evidence that Helios was aware of GenomeDx's patent portfolio before the commercial launch of ProstaSignal™ on October 7, 2024, and that Helios potentially conducted a freedom-to-operate analysis acknowledging infringement risk. Such evidence would be critical to GenomeDx's willfulness theory and its claim for enhanced damages under 35 U.S.C. § 284. If Helios knowingly launched ProstaSignal™ in the face of a recognized infringement risk, this would significantly strengthen GenomeDx's position at trial and potentially support an award of up to treble damages.
Moreover, even if the documents are ultimately ruled privileged, the information we have gleaned from the privilege log entries about the existence of a freedom-to-operate analysis and the fact of communications with Corinth Ventures regarding GenomeDx's patents can be used to frame deposition questions on the non-privileged factual aspects of those communications — who was involved, when the analysis was conducted, what patents were analyzed, and who received copies of the analysis — without seeking privileged legal conclusions. This approach is consistent with the well-established principle that the privilege protects communications, not underlying facts.
E. Planned Third-Party Subpoena to Corinth Ventures Fund III, LP
Subpoena Status. A draft subpoena duces tecum directed to Corinth Ventures Fund III, LP has been prepared. The subpoena has not yet been served and requires Catherine Bloom's review and approval before service. Corinth Ventures Fund III, LP is located at 399 Boylston Street, Suite 1100, Boston, MA 02116. The firm's Managing Director is Priya Chandrasekaran.
Scope of Requested Documents. The draft subpoena seeks production of the following categories of documents from Corinth Ventures:
• Investment memoranda relating to Corinth's investment in Helios, including any discussions of Helios's competitive position relative to GenomeDx and the Decipher® test.
• Due diligence reports prepared in connection with Corinth's investment in Helios, including any analysis of intellectual property risk, patent infringement exposure, or freedom-to-operate considerations.
• Board observation notes or minutes from Helios board meetings at which representatives of Corinth Ventures were present, to the extent those notes or minutes reference GenomeDx's patent portfolio, the Decipher® test, or Helios's freedom-to-operate analysis.
• Communications between Corinth Ventures personnel and Helios personnel (including officers, directors, employees, and counsel) discussing GenomeDx's patent portfolio, freedom-to-operate analysis, or ProstaSignal™ competitive positioning relative to Decipher®.
Procedural Considerations. Corinth Ventures Fund III, LP is a Delaware limited partnership headquartered in Massachusetts. Under Federal Rule of Civil Procedure 45, a subpoena must command compliance at a place within 100 miles of where the person resides, is employed, or regularly transacts business in person. Because this case is pending in the Northern District of California, the subpoena will likely need to be served on Corinth Ventures in the District of Massachusetts, and compliance should be commanded at a location within 100 miles of Corinth's Boston headquarters.
Under Rule 45(a)(2), as amended, a subpoena may be issued from the court where the action is pending and may be served anywhere in the United States. This simplifies the procedural mechanics, but we may still need to coordinate with local counsel in Boston to ensure proper service and to handle any motion practice that may arise. We should identify and retain local counsel promptly if we have not already done so.
Timing Concern. The timing of this subpoena is a matter of some urgency. Fact discovery closes on March 6, 2026. Even under an expedited production schedule, it is unlikely that Corinth Ventures will be able to collect, review, and produce responsive documents within the remaining time before the close of fact discovery. We therefore anticipate the need to negotiate a production schedule with Corinth Ventures that extends slightly beyond the current deadline. This could be accomplished by stipulation with Helios (who may be willing to agree if the extension is limited) or by court order.
Alternatively, if we obtain a broader extension of the fact discovery deadline (as discussed in Section VII.B), the Corinth Ventures subpoena timeline would fit within the extended discovery period. In any event, the subpoena should be served as promptly as possible to start the clock running and to preserve GenomeDx's ability to obtain this critical third-party evidence.
Anticipated Opposition. We should anticipate that Helios and/or Corinth Ventures will move to quash the subpoena. Helios is likely to argue that the subpoenaed documents are irrelevant or, alternatively, that they are protected by the same privilege claims at issue in the pending motion to compel. Corinth Ventures may separately move to quash on grounds of undue burden, arguing that it is a non-party investor with no obligation to participate in patent infringement litigation between its portfolio company and a competitor. We should prepare an opposition brief in advance to ensure a rapid response to any motion to quash.
Strategic Significance. The documents held by Corinth Ventures could corroborate or supplement the 34 withheld documents at issue in the motion to compel. If Helios shared board presentations or FTO analyses with Corinth Ventures, then Corinth's copies of those documents would not be subject to Helios's privilege claims (to the extent the privilege was waived by the disclosure). Moreover, Corinth's own internal investment memoranda and due diligence reports — which are not communications between Helios and its attorneys — would not be protected by Helios's attorney-client privilege at all. These documents could independently establish Helios's pre-launch knowledge of GenomeDx's patents and the infringement risk associated with ProstaSignal™.
III. Deposition Plan — Helios Witnesses
A. Overview and Prioritization
GenomeDx has identified five priority depositions of Helios personnel. These depositions are rank-ordered by strategic importance as follows:
1. Dr. Elaine Kossack (Chief Scientific Officer) — Highest Priority
2. Dr. Nathan Ashford (Chief Executive Officer)
3. Dr. Anton Rykov (Senior Scientist, Bioinformatics)
4. Derek Mallinson (Vice President, Commercial Operations)
5. Sara Whitmore (General Counsel / 30(b)(6) Designee on FTO and IP Clearance Topics)
Each of these witnesses possesses unique knowledge that is essential to GenomeDx's case. Dr. Kossack and Dr. Rykov are central to the infringement analysis, as they were the principal architects of ProstaSignal™'s scientific design and algorithm. Dr. Ashford is critical to the willfulness theory, as the ultimate decision-maker who authorized the commercial launch of ProstaSignal™ despite potential knowledge of infringement risk. Derek Mallinson is the key witness for damages, as the individual responsible for commercial strategy, pricing, and market positioning. And Sara Whitmore, as General Counsel and 30(b)(6) designee on FTO topics, can provide factual testimony about the existence, scope, and recipients of any freedom-to-operate analysis, even if the substance of the analysis itself is privileged.
Scheduling. All five depositions should ideally be completed before the March 6, 2026 fact discovery close. We propose scheduling the depositions over a two-week period, with approximately one day allocated per deposition. Given the compressed timeline, it may be necessary to conduct two depositions per week or to seek a stipulated extension of the discovery deadline (as discussed in Section VII.B). Peter Vassiliev will coordinate scheduling with Danielle Forrest and Owen Chu at Ridgecrest Durneval LLP.
Location. Depositions of California-based witnesses should be noticed for either San Diego (Helios's CLIA-certified laboratory at 9830 Mesa Rim Road, Suite 140, San Diego, CA 92121) or San Francisco (Calderwood & Harkness offices at 555 Mission Street, Suite 3100, San Francisco, CA 94105). Dr. Kossack, Dr. Rykov, and Derek Mallinson are believed to be based in San Diego, where Helios's laboratory and principal offices are located.
Dr. Ashford and Sara Whitmore are understood to be based in Boston, Massachusetts, where Helios maintains a secondary office. For these two witnesses, we should propose that the depositions be conducted either in Boston (at a location to be agreed upon or at our local counsel's offices) or via stipulated video deposition. Video depositions may be acceptable for scheduling convenience, but we would strongly prefer in-person depositions for both Ashford and Whitmore given the importance of their testimony — body language, demeanor, and document handling are particularly important for witnesses who may be evasive on topics related to willfulness and privilege.
B. Dr. Elaine Kossack (CSO) — Priority 1
Role and Relevance. Dr. Elaine Kossack is Helios's Chief Scientific Officer and the individual who led the development of ProstaSignal™. She was responsible for the scientific design of the test, including the selection of the gene expression panel, the choice of classifier methodology, and the clinical validation studies. Her testimony will be central to both the infringement and invalidity analyses.
Key Topics for Examination.
Genesis and Timeline of ProstaSignal™ Development. We will seek detailed testimony from Dr. Kossack regarding the inception and timeline of ProstaSignal™ development. According to publicly available information and Helios's marketing materials, ProstaSignal™ development began in approximately 2020. We need to understand when the initial concept was formulated, who was involved in the early-stage scientific planning, and what competitive products were on the team's radar during the conceptualization phase. Establishing an early awareness of GenomeDx's Decipher® test during this period is critical to the willfulness theory.
Selection of the 24-Gene Expression Panel. ProstaSignal™ uses a 24-gene expression panel to generate a prognostic score for prostate cancer patients. GenomeDx's patented Decipher® test uses a 22-gene panel. Critically, 19 of the 24 genes in ProstaSignal™'s panel overlap with GenomeDx's patented gene set. This degree of overlap — nearly 90% of GenomeDx's panel — is highly probative of infringement and raises serious questions about whether ProstaSignal™'s gene panel was independently derived or was influenced by GenomeDx's published gene set. We will question Dr. Kossack in detail about the rationale for choosing each gene, the scientific literature and data that informed the selection, and the extent to which GenomeDx's published 22-gene panel was considered, evaluated, or used as a starting point during the gene selection process.
Classifier Methodology. The '893 Patent claims a method that employs a random-forest classifier for risk stratification. ProstaSignal™ uses a gradient-boosted decision tree classifier. We anticipate that Helios will argue non-infringement based on the difference between these two classifier types. Dr. Kossack's testimony on this topic will be critical for establishing whether a gradient-boosted decision tree classifier is structurally and functionally equivalent to a random-forest classifier under the doctrine of equivalents. We will ask whether the ProstaSignal™ team considered and tested random-forest classifiers during development and, if so, why a gradient-boosted approach was ultimately selected. Evidence that random-forest classifiers were evaluated and rejected — particularly if the rejection was motivated by a desire to design around GenomeDx's patents — would be highly relevant to both infringement and willfulness.
Training Data. We will seek testimony regarding the training data used to develop the ProstaSignal™ algorithm. Key questions include the specific datasets used, the cohort size, and whether publicly available datasets — including those published by GenomeDx researchers — were used to train the classifier. The '893 Patent includes a claim limitation requiring a minimum 500-patient cohort for classifier training. If Helios's training data meets this threshold, it would tend to support infringement under the literal terms of the claim.
Awareness of GenomeDx Patents. We will ask Dr. Kossack directly whether she was aware of the '271, '893, or '647 Patents at any time during the development of ProstaSignal™. We will also probe whether she received any instructions from management, legal, or outside counsel regarding design-around efforts or patent risk mitigation. While she may assert that specific communications with counsel are privileged, she cannot refuse to answer whether she was aware of the patents or whether she received any instructions regarding them — only the content of privileged communications is protected.
Clinical Validation Studies. Dr. Kossack oversaw ProstaSignal™'s clinical validation studies. We will seek testimony on the design of those studies, the patient cohorts used, the endpoints measured, and the results obtained. This testimony will be relevant to the technical comparison between ProstaSignal™ and Decipher® and may provide additional data points for the infringement analysis.
Independent Development Defense. Helios has signaled through its discovery responses that it intends to argue that ProstaSignal™ was independently developed based on publicly available gene-expression datasets. While independent development is not a defense to patent infringement, it may be relevant to the willfulness analysis (if Helios can show good faith reliance on public data) and to the invalidity analysis (if Helios contends that the patented methods were obvious in light of publicly available data). Dr. Kossack's testimony will be critical for testing the credibility of this narrative.
Communications Regarding Patent Risk. We will probe Dr. Kossack regarding any communications she had with Dr. Nathan Ashford, Sara Whitmore, or outside counsel regarding patent risk associated with ProstaSignal™. While the substance of communications with counsel may be privileged, the fact and timing of such communications are not.
Document Preparation. In preparation for Dr. Kossack's deposition, the team should review the following categories of documents:
• Kossack's laboratory notebooks from the ProstaSignal™ development period (2020–2024);
• Internal emails to and from Kossack regarding gene selection, classifier methodology, and ProstaSignal™ design;
• ProstaSignal™ development protocols, standard operating procedures, and design specifications;
• Gene-selection analyses, including any spreadsheets, statistical analyses, or literature reviews used to select the 24-gene panel;
• Any FTO-related documents produced by Helios in which Kossack is a recipient, author, or participant; and
• The 34 withheld privilege log documents — even though these have not been produced, we should review the privilege log entries to identify questions about the facts underlying those documents.
C. Dr. Nathan Ashford (CEO) — Priority 2
Role and Relevance. Dr. Nathan Ashford is Helios's Chief Executive Officer and the individual credited with conceiving the ProstaSignal™ concept. He was the ultimate decision-maker for the commercial launch of ProstaSignal™ on October 7, 2024. His testimony is critical to GenomeDx's willfulness theory, as he had the authority and responsibility to ensure that Helios's products did not infringe third-party patents before launching them commercially. He is also a key witness for damages, as the individual who set the competitive strategy and pricing for ProstaSignal™.
Key Topics for Examination.
Conception and Competitive Landscape. We will question Dr. Ashford regarding the original conception of ProstaSignal™ as a commercial product. We need to understand the competitive landscape analysis that informed the decision to develop ProstaSignal™, including Ashford's specific knowledge of GenomeDx's Decipher® test and GenomeDx's dominant market position. GenomeDx held approximately 74% market share in genomic prostate cancer prognostic testing prior to the launch of ProstaSignal™. A CEO who decided to enter this market must have been aware of the dominant player and its patent portfolio.
Commercial Launch Decision-Making. The commercial launch of ProstaSignal™ on October 7, 2024 is the relevant date for assessing willfulness. We will seek detailed testimony from Dr. Ashford about the decision-making process that led to the launch, including what approvals were required, who was involved in the decision, and whether any patent infringement risk was discussed or considered before the launch. If Ashford authorized the launch with knowledge of infringement risk — or with reckless disregard for such risk — this would support a finding of willfulness under Halo Electronics, Inc. v. Pulse Electronics, Inc., 579 U.S. 93 (2016).
Board Presentations and Investor Materials. We will question Dr. Ashford regarding board presentations made to Corinth Ventures Fund III, LP and other investors. These presentations are likely to contain competitive positioning analysis, market share projections, and potentially references to GenomeDx's patents or the Decipher® test. The content of these presentations is directly relevant to willfulness (showing knowledge of GenomeDx's patents) and to damages (showing expected revenue and market capture).
Business Plan and Revenue Projections. We will seek testimony regarding Helios's business plan and revenue projections for ProstaSignal™. Based on publicly available financial data and GenomeDx's preliminary analysis, Helios's FY 2024 revenue was approximately $71.2 million, and ProstaSignal™ is estimated to have generated approximately $32,088,000 in revenue from its October 2024 launch through March 2025, based on approximately 8,400 tests at an average reimbursement of $3,820 per test. These figures are critical inputs for the damages analysis and must be confirmed or refined through deposition testimony and document production.
Freedom-to-Operate Analysis. We will question Dr. Ashford about any freedom-to-operate analysis or patent clearance process conducted in connection with ProstaSignal™. While the substance of any legal advice received may be privileged, the factual aspects — whether such an analysis was commissioned, when, by whom, and what patents were analyzed — are fair game for deposition testimony.
Design-Around Instructions. If Helios's scientific team was instructed to design around GenomeDx's patents, this would be powerful evidence of awareness and willfulness. We will ask Dr. Ashford whether he gave any instructions to the scientific team regarding design-around efforts and, if so, when and to whom.
Pricing and Competitive Strategy. ProstaSignal™ is priced at $3,820 per test, compared to GenomeDx's Decipher® at $4,210 per test. This pricing differential — approximately $390 per test, or roughly a 9% discount — suggests that Helios adopted an aggressive pricing strategy designed to capture GenomeDx's customers. We will question Ashford about the rationale for this pricing, the competitive positioning strategy, and the customer acquisition plan.
Document Preparation. In preparation for Dr. Ashford's deposition, the team should review:
• Ashford's emails and calendar entries from the ProstaSignal™ development and launch periods;
• Board meeting minutes and presentations;
• Investor presentations and pitch decks prepared for Corinth Ventures and others;
• Strategic planning documents, competitive analyses, and market research;
• Commercial launch materials, including internal launch timelines and checklists; and
• Any documents in which Ashford is referenced in the privilege log entries for the 34 challenged documents.
D. Dr. Anton Rykov (Senior Scientist, Bioinformatics) — Priority 3
Role and Relevance. Dr. Anton Rykov is a Senior Scientist in Helios's Bioinformatics group who led the development of the ProstaSignal™ classifier algorithm. He is the individual with the most granular technical knowledge of the algorithm's design, architecture, and training methodology. His testimony will be critical for the claim-by-claim infringement analysis and for evaluating the technical differences between ProstaSignal™ and the methods claimed in the '271, '893, and '647 Patents.
Key Topics for Examination.
Gradient-Boosted Decision Tree Classifier. We will seek detailed technical testimony from Dr. Rykov about the gradient-boosted decision tree classifier used in ProstaSignal™. This is the single most technically important topic in the case, as the '893 Patent claims a method employing a "random-forest classifier" and Helios will argue that its gradient-boosted decision tree classifier is a fundamentally different algorithm. We need to establish through Rykov's testimony the structural and functional similarities between the two classifier types — both are ensemble methods that aggregate predictions from multiple decision trees — as well as any testimony that suggests the choice of gradient-boosted trees over random forests was motivated by a desire to avoid the literal terms of GenomeDx's patent claims.
Random-Forest Classifier Evaluation. A critical line of questioning will probe whether the ProstaSignal™ team evaluated or tested random-forest classifier models during the development process. If Rykov's team built and tested random-forest models and subsequently switched to gradient-boosted trees, this would be strong circumstantial evidence of a deliberate design-around strategy. We should ask specifically whether any random-forest models were built, what their performance characteristics were, why they were abandoned, and whether any instructions were received from management or legal regarding the choice of classifier.
Feature Selection Methodology. We will question Dr. Rykov about the methodology used to select the 24 genes in the ProstaSignal™ panel. Specifically, we need to understand whether the gene set was derived from or influenced by GenomeDx's published 22-gene panel. If Rykov's team began with GenomeDx's 22-gene panel and added or substituted genes, this would strongly support infringement. Even if the gene selection was ostensibly based on an independent analysis of gene-expression data, the 19-gene overlap with GenomeDx's panel requires explanation.
Training Data and Cohort Size. The '893 Patent includes a limitation requiring a minimum 500-patient cohort for classifier training. We will seek testimony from Rykov about the specific datasets used to train the ProstaSignal™ classifier, including the cohort size, the sources of the data, and whether any of the data originated from studies conducted by GenomeDx researchers or published in the same literature that informed GenomeDx's patent claims.
Normalization Methodology. The '271 and '893 Patents include limitations relating to reference-gene normalization of gene-expression data from formalin-fixed paraffin-embedded ("FFPE") prostate tissue samples. We will question Rykov about whether ProstaSignal™ uses a reference gene panel for normalization and, if so, which reference genes are used. This testimony is relevant to claim mapping under both literal infringement and doctrine of equivalents theories.
ProstaScore Generation and Risk Classification. ProstaSignal™ generates a "ProstaScore" on a 0–100 scale and classifies patients into Low, Intermediate, and High risk categories. This maps directly to the "classifying the patient into a risk category" limitation found in the asserted claims. We will question Rykov about the ProstaScore generation methodology and the thresholds used for risk classification.
Integration with Clinical Variables. The '647 Patent claims a method that combines a biomarker score with clinical variables, including Gleason grade group and pre-operative PSA levels. We will seek testimony from Rykov about whether ProstaSignal™ integrates the ProstaScore with Gleason grade group and pre-operative PSA data, and if so, how this integration is performed and what outputs are generated. This testimony is critical for mapping ProstaSignal™'s functionality to the '647 Patent claims.
Patent Awareness. As with Dr. Kossack, we will question Dr. Rykov about his awareness of GenomeDx's patents during the algorithm development process.
Document Preparation. In preparation for Dr. Rykov's deposition, the team should review:
• Rykov's code documentation, including source code comments, version histories, and commit logs;
• Algorithm design documents, technical specifications, and architecture diagrams;
• Validation study protocols and results;
• Internal technical presentations, including any presentations to Helios's scientific advisory board;
• Any correspondence between Rykov and Kossack regarding GenomeDx's intellectual property or the Decipher® test; and
• Documents produced under the Protective Order with "Highly Confidential — Attorneys' Eyes Only" designation relating to ProstaSignal™ classifier design.
E. Derek Mallinson (VP, Commercial Operations) — Priority 4
Role and Relevance. Derek Mallinson is Helios's Vice President of Commercial Operations and the individual who led the market launch and competitive positioning of ProstaSignal™. His testimony is primarily relevant to the damages analysis, including lost profits, reasonable royalty, and market share data. He is also a key witness for establishing that ProstaSignal™ was deliberately positioned as a direct substitute for GenomeDx's Decipher® test — a factual predicate for the two-supplier market analysis that supports GenomeDx's lost-profits claim.
Key Topics for Examination.
Commercial Launch Planning. We will seek testimony about the planning process for the October 7, 2024 commercial launch of ProstaSignal™. Key questions include the timeline for commercial preparations, the go-to-market strategy, and the decision-making process regarding launch timing.
Market Analysis and Competitive intelligence. We will question Mallinson about Helios's market analysis and competitive intelligence regarding GenomeDx's Decipher® test. We expect that Helios conducted detailed competitive analyses characterizing ProstaSignal™ as competing directly with or substituting for Decipher® in the genomic prostate cancer prognostic testing market. Any documents or testimony showing that Helios viewed Decipher® as its primary competitor would support the two-supplier market theory.
Customer Acquisition Strategy. We will seek testimony about which accounts — hospitals, urologists, oncologists, cancer centers — were targeted by Helios's sales team. Evidence of direct diversion of GenomeDx customers is critical for the lost-profits analysis. If Helios's sales team specifically targeted GenomeDx's existing Decipher® customers with competitive pricing and marketing, this would strongly support a finding of customer diversion.
Sales and Marketing Materials. We will question Mallinson about any sales and marketing materials that reference Decipher® or GenomeDx, including head-to-head comparison materials, competitive selling guides, or talking points used by Helios's sales representatives. Such materials are often powerful evidence at trial.
Test Volume and Financial Data. We will seek testimony on ProstaSignal™'s test volume data. Based on GenomeDx's preliminary analysis, approximately 8,400 ProstaSignal™ tests were conducted from October 2024 through March 2025, at an average reimbursement of $3,820 per test, yielding estimated revenue of approximately $32,088,000. We need to confirm or refine these figures through Mallinson's testimony. We will also seek data on reimbursement via the Medicare MolDX program under MAAA code 0239M, which Helios obtained in September 2024.
Market Share Impact. GenomeDx's market share in genomic prostate cancer prognostic testing declined from approximately 74% to approximately 68% following the launch of ProstaSignal™. We will question Mallinson about Helios's own market share data and estimates, as well as any internal analyses of the impact of ProstaSignal™ on GenomeDx's market position.
Non-Infringing Alternatives. For purposes of the lost-profits analysis, GenomeDx must demonstrate that there were no acceptable non-infringing alternatives available to Helios's customers. We will question Mallinson about the competitive landscape, the availability of alternative prognostic tests, and Helios's own view of the market — specifically, whether Helios viewed the market as a two-supplier market (GenomeDx and Helios) or whether it considered other tests to be meaningful competitors.
Document Preparation. In preparation for Mallinson's deposition, the team should review:
• Marketing plans and go-to-market strategy documents for ProstaSignal™;
• Sales reports, pipeline data, and CRM records;
• Competitive analyses, market research reports, and competitive intelligence materials;
• Financial projections and revenue forecasts for ProstaSignal™;
• Sales training materials and competitive selling guides; and
• Any documents referencing GenomeDx, Decipher®, or head-to-head comparisons.
F. Sara Whitmore (General Counsel / 30(b)(6) Designee) — Priority 5
Role and Relevance. Sara Whitmore is Helios's General Counsel and has been designated (or is expected to be designated) as Helios's 30(b)(6) witness on topics related to freedom-to-operate analysis and IP clearance. She oversaw the legal aspects of the ProstaSignal™ launch, including any patent clearance process conducted before commercialization. Her testimony is uniquely important because she sits at the intersection of legal and business decision-making at Helios, and her factual testimony about the FTO process — even without disclosing privileged legal conclusions — can establish the critical facts needed for the willfulness analysis.
Key Topics for Examination.
Freedom-to-Operate Analysis. We will question Whitmore about the existence, scope, and timeline of any freedom-to-operate analysis conducted by Helios regarding GenomeDx's patents. Key factual questions include: When was the FTO analysis commissioned? Who conducted it — internal legal staff, Ridgecrest Durneval LLP, or prior outside counsel? Which patents were analyzed? When was the analysis completed? Who received copies of the analysis? Was the FTO analysis completed before or after the October 7, 2024 launch?
Opinions of Counsel. We will seek to identify any formal opinions of counsel obtained by Helios regarding non-infringement or invalidity of the '271, '893, and '647 Patents. If Helios obtained such opinions, it may seek to assert an "advice of counsel" defense to willfulness. However, asserting this defense would require waiver of the attorney-client privilege as to the opinion. If Helios has not obtained opinions of counsel, this fact itself may be probative of willfulness.
Privilege Log Entries. We will question Whitmore about the specific privilege log entries for the 34 challenged documents. We will seek to establish the factual basis for each privilege assertion — who created each document, who received it, when it was created, and what its business purpose was — without seeking disclosure of privileged content. In particular, we will probe whether documents were shared with Corinth Ventures or other non-lawyer investors, which would undermine the privilege assertions.
IP Clearance Process. Beyond the FTO analysis, we will question Whitmore about Helios's broader IP clearance process for new products. Does Helios have a standard protocol for evaluating patent risk before commercial launch? Was that protocol followed for ProstaSignal™? Who is responsible for IP clearance within Helios?
Post-Launch Communications. We will seek testimony about post-launch communications regarding GenomeDx's complaint or any pre-suit cease-and-desist correspondence. If GenomeDx sent a cease-and-desist letter before filing suit, Whitmore's testimony about Helios's response to that letter would be relevant to willfulness.
Insurance Coverage. We will seek basic factual testimony about Helios's insurance coverage for patent infringement defense. This information may be relevant to damages and to GenomeDx's ability to collect on any judgment.
Document Preparation. In preparation for Whitmore's deposition, the team should:
• Review the privilege log in detail, with particular focus on the 34 challenged documents;
• Prepare specific questions about each privilege log entry, targeting factual (non-privileged) information;
• Review any non-privileged documents that are adjacent to the FTO analysis — e.g., emails scheduling FTO discussions, invoices from outside counsel for FTO work, or cover letters transmitting FTO-related materials;
• Coordinate deposition strategy with the pending motion to compel; and
• Prepare a detailed privilege boundary analysis to guide questioning during the deposition.
Note on Privilege Boundaries. The Whitmore deposition will require particularly careful navigation of privilege boundaries. Whitmore, as General Counsel, will be represented by Ridgecrest Durneval LLP and can be expected to assert privilege frequently — potentially on a question-by-question basis. Our examining attorney must be prepared to distinguish between (a) questions seeking privileged legal advice or mental impressions, which must be respected, and (b) questions seeking underlying facts, which are not protected by the privilege. The seminal principle is that the privilege "protects communications, not the underlying facts." Upjohn Co. v. United States, 449 U.S. 383, 395 (1981). Accordingly, we can properly ask who was involved, when the FTO was conducted, what patents were analyzed, and who received copies — we cannot ask what legal conclusions were reached or what advice was given.
We should also be prepared to make a record on the transcript if Helios's counsel instructs Whitmore not to answer questions that we believe seek non-privileged factual information. Such a record would be necessary to support any post-deposition motion to compel testimony.
IV. Preparation for Defense Depositions of GenomeDx Witnesses
A. Helios's 30(b)(6) Notice (12 Topics)
Helios served a Rule 30(b)(6) deposition notice on GenomeDx on February 24, 2026. The notice designates 12 topics for corporate testimony. Under Rule 30(b)(6), GenomeDx has an obligation to designate one or more witnesses to testify on each noticed topic, and those witnesses must be prepared to provide testimony that represents the corporation's position — not merely the witness's personal knowledge.
Based on Helios's counterclaims, discovery posture, and the general contours of its defense strategy, we anticipate that the 12 noticed topic areas will include the following:
1. Development and prosecution history of the '271, '893, and '647 Patents. This topic will likely encompass the conception, reduction to practice, and prosecution of each asserted patent, including any rejections, amendments, and arguments made to the PTO during prosecution.
2. GenomeDx's Decipher® test design, gene panel selection, and classifier methodology. Helios will seek testimony on the technical details of the Decipher® test, including the scientific basis for the 22-gene panel, the random-forest classifier methodology, and the training data used.
3. Licensing history. Helios will seek testimony on GenomeDx's history of licensing the asserted patents, including the Veridian Molecular Labs license dated April 3, 2022. This testimony will be relevant to the reasonable-royalty damages analysis.
4. Damages and financial data. Helios will seek testimony on GenomeDx's revenue, market share, reimbursement rates, incremental margins, and other financial data relevant to the damages theories in the case.
5. IP enforcement history and prior litigation. Helios will seek testimony on GenomeDx's history of enforcing the asserted patents, including any prior litigation, cease-and-desist letters, or licensing negotiations.
6. Relationship with Pinnacle Biosciences Capital, LP and impact on IP strategy. Helios may seek to explore GenomeDx's relationship with its own investors and whether GenomeDx's IP enforcement strategy is driven by investor pressure or financial objectives rather than genuine infringement concerns.
Additional topics may include GenomeDx's claim construction positions, its identification of accused instrumentalities, its contentions regarding literal infringement and doctrine of equivalents, and the factual basis for its willfulness allegations.
Recommended Designees. We recommend the following witness designations:
• Dr. Rajan Mehta — Topics on patent development, Decipher® test design, and technical matters. Dr. Mehta is a named inventor on all three asserted patents and the Chief Technology Officer. He has the deepest knowledge of the scientific basis for the patents and the Decipher® test. He is the natural designee for the most technically significant topics.
• Victoria Sung — Topics on licensing, IP strategy, and enforcement history. As General Counsel, Ms. Sung has direct knowledge of GenomeDx's licensing history (including the Veridian license), its IP enforcement strategy, and any prior litigation or licensing negotiations. She is the appropriate designee for these topics.
• Thomas Brennan — Topics on financial data, revenue, market share, and damages inputs. As Chief Financial Officer, Mr. Brennan has direct access to and responsibility for GenomeDx's financial data. He is the appropriate designee for topics relating to revenue, profitability, market share, reimbursement rates, and incremental margins.
• Dr. Kevin Ostrowski — Topics on patent prosecution and IP portfolio management. Dr. Ostrowski is the Vice President of intellectual Property and a named inventor on the '647 Patent. He has detailed knowledge of the prosecution history of each asserted patent and the broader IP portfolio management strategy.
B. Individual Witness Preparation Notes
Dr. Rajan Mehta. Dr. Mehta is GenomeDx's most important witness and will be subjected to intensive cross-examination by Helios's counsel. He will be questioned extensively on the prosecution history of the asserted patents, and Helios will attempt to elicit admissions that narrow the scope of the claims or support prosecution history estoppel arguments.
Two areas of particular sensitivity require thorough preparation:
First, the '271 Patent prosecution history. During prosecution, GenomeDx amended the claims of the '271 Patent to add specific technical steps — including RNA extraction from formalin-fixed paraffin-embedded ("FFPE") tissue samples and reference-gene normalization — to overcome a § 101 rejection under Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014). Helios will likely argue that these amendments constitute prosecution history estoppel, narrowing the scope of the claims to exclude methods that do not use the specific technical steps added during prosecution. We must prepare Dr. Mehta to explain the amendments accurately without making concessions that could be used to narrow the claims beyond their proper scope. He should be prepared to testify that the amendments clarified, but did not narrow, the claims — or, alternatively, that the amendments were directed to a different issue (§ 101 eligibility) and do not limit the claims for purposes of infringement analysis.
Second, the '893 Patent distinction over the Nakamura reference. During prosecution of the '893 Patent, GenomeDx distinguished the Nakamura prior art reference by arguing that Nakamura did not disclose the specific random-forest classifier training methodology and minimum cohort size claimed in the '893 Patent. Helios may attempt to use this distinction to argue (a) that the '893 Patent is limited to the specific training methodology distinguished from Nakamura, and (b) that ProstaSignal™'s gradient-boosted decision tree classifier does not infringe because it uses a different classifier type. We must prepare Dr. Mehta to explain the Nakamura distinction without creating unintended narrowing admissions and to testify consistently with GenomeDx's claim construction positions as set forth in the August 2025 preliminary claim construction analysis memo.
Overall, preparation of Dr. Mehta must be closely coordinated with GenomeDx's claim construction strategy. Every answer he gives on prosecution history and claim scope will be scrutinized for consistency with GenomeDx's positions in the upcoming Markman hearing (scheduled for September 18, 2026). Catherine Bloom should participate directly in Dr. Mehta's preparation sessions.