ATTORNEY-CLIENT PRIVILEGED & CONFIDENTIAL ATTORNEY WORK PRODUCT — DO NOT FORWARD OR DISTRIBUTE
Dear Victoria and Jonathan,
I am writing to provide our quarterly case status update covering developments during Q4 2025, as well as a significant ruling entered earlier this week that materially strengthens GenomeDx's litigation posture.
**Executive Summary:** On January 13, 2026, Judge Jessica W. Langston denied Helios's motion to dismiss Counts II and III — the counts asserting the '893 Patent (U.S. Patent No. 11,204,893) and the '647 Patent (U.S. Patent No. 11,891,647) — under 35 U.S.C. § 101. All three patents-in-suit remain in the case. This is a significant early victory. With that motion behind us, the case is now entering the most intensive phase of active fact discovery, which closes on March 6, 2026. Below is a detailed summary organized by topic.
---
**I. Court's Ruling on Helios's Motion to Dismiss (January 13, 2026)**
Helios filed its motion to dismiss on September 15, 2025, arguing that the asserted claims of the '893 and '647 Patents are directed to abstract ideas — specifically, mathematical algorithms applied to natural phenomena (gene expression levels) — without an inventive concept. Helios relied heavily on *Mayo Collaborative Services v. Prometheus Laboratories, Inc.*, 566 U.S. 66 (2012), and *Association for Molecular Pathology v. Myriad Genetics, Inc.*, 569 U.S. 576 (2013). GenomeDx filed its opposition on November 3, 2025, and Helios replied on November 17, 2025.
The Court held that the § 101 challenge was premature absent full claim construction, declined to resolve patent eligibility at the pleading stage, and denied the motion in its entirety.
This ruling has several important implications:
First, it preserves all three counts and all asserted claims, keeping GenomeDx's case intact as we move into discovery and claim construction.
Second, while Helios retains the ability to reassert its § 101 defense at the summary judgment stage after claim construction, the denial is a meaningful signal. The Court's order specifically noted that GenomeDx's claims are "plausibly directed to specific, concrete diagnostic improvements" — language that tracks the argument we pressed in our opposition brief, emphasizing the specific technical steps recited in the claims, including RNA extraction from FFPE (formalin-fixed, paraffin-embedded) samples and reference-gene normalization. This framing should carry forward as helpful context into claim construction and the Markman proceedings.
Third, Helios's invalidity counterclaims under §§ 101, 102, and 103, as well as its non-infringement and unenforceability counterclaims, remain in the case. GenomeDx answered those counterclaims on May 30, 2025, and they will be addressed through the ordinary course of discovery, claim construction, and dispositive motions.
---
**II. Stipulated Protective Order (Entered December 18, 2025)**
Following a meet-and-confer on December 5, 2025, between our team and Helios's counsel at Ridgecrest Durneval LLP (Marcus Pellegrini and Danielle Forrest), the parties reached agreement on a Stipulated Protective Order. The order establishes a two-tier confidentiality structure: "Confidential" and "Highly Confidential — Attorneys' Eyes Only." Judge Langston entered the order on December 18, 2025.
This was a necessary step. Helios had initially objected to GenomeDx's Request for Production No. 14 — which seeks all documents relating to the design, development, and validation of the ProstaSignal™ classifier algorithm, including training data, feature selection methodology, and model architecture — on trade-secret grounds. The Protective Order resolved that dispute and enables both sides to produce sensitive technical and financial materials with appropriate safeguards.
---
**III. Document Production Status**
On GenomeDx's side, we have identified 11 custodians, including Dr. Rajan Mehta, Dr. Kevin Ostrowski, Dr. Miriam Langford, Victoria Sung, and seven R&D and commercial employees. We have collected approximately 482,000 documents (1.7 TB) from these custodians. After privilege review and de-duplication, GenomeDx has produced approximately 218,000 documents to date.
Helios has produced approximately 167,000 documents, though this production is incomplete — the ongoing privilege dispute, discussed below, accounts for a portion of the shortfall.
E-discovery is being managed by Canfield Document Solutions LLC (Sandra Neville, project manager) using the RevealIQ platform with predictive coding (TAR 2.0). Our current estimate for total e-discovery costs through trial remains in the range of $1.4M–$1.8M.
---
**IV. Pending Privilege Dispute and Motion to Compel**
GenomeDx served 47 Requests for Production on Helios on January 27, 2026. Among the documents Helios has withheld, it asserted attorney-client privilege and work-product protection over 83 documents. We have challenged 34 of those withholdings — specifically documents responsive to our RFP Nos. 22, 23, and 31, which seek pre-launch business plans, board presentations, and investor materials referencing GenomeDx's patents or the Decipher® test.
On January 30, 2026, we filed a motion to compel production of those 34 documents, supported by a memorandum of points and authorities and a declaration from Peter Vassiliev attaching the parties' meet-and-confer correspondence with Ridgecrest Durneval. Our central argument is that these documents were shared with non-lawyer business personnel and investors — including Corinth Ventures Fund III, LP, which holds a 58.7% majority equity stake in Helios — and were not made for the purpose of obtaining legal advice, thus waiving the attorney-client privilege. We also argue that the predominantly business-oriented content of these materials vitiates any privilege claim.
The motion is pending before Magistrate Judge David R. Cabrera. Briefing is ongoing.
I want to emphasize the potential significance of these documents. They may demonstrate Helios's awareness of GenomeDx's patent portfolio before Helios's commercial launch, and reveal the nature — or absence — of any freedom-to-operate analysis. This evidence bears directly on our willfulness theory and the availability of enhanced damages under 35 U.S.C. § 284.
---
**V. Upcoming discovery Activities and Key Deadlines**
Fact discovery closes on March 6, 2026 — less than two months from today. We have a substantial amount of work to complete in that window. Here is a summary of key activities:
*Interrogatories:* GenomeDx served 15 interrogatories on Helios on February 10, 2026. Helios has served 17 interrogatories on GenomeDx, and we are currently preparing GenomeDx's responses.
*Rule 30(b)(6) Depositions:*
Helios served a Rule 30(b)(6) deposition notice on GenomeDx on February 24, 2026, covering 12 topics. We are preparing designated witnesses: Victoria Sung on licensing and IP strategy, and Thomas Brennan on financial and damages topics.
GenomeDx served a Rule 30(b)(6) deposition notice on Helios on February 28, 2026, covering 14 topics, including ProstaSignal™ development timeline, algorithm design, gene selection methodology, clinical validation, awareness of GenomeDx patents, freedom-to-operate analysis, commercial launch strategy, revenue and pricing, and competitive intelligence regarding the Decipher® test.
*Key Individual Depositions (Planned):*
On the Helios side, we intend to depose the following witnesses: Dr. Nathan Ashford (CEO, who conceived the ProstaSignal™ concept), Dr. Elaine Kossack (CSO, who led ProstaSignal™ development), Dr. Anton Rykov (Senior Scientist, Bioinformatics, who developed the algorithm), Derek Mallinson (VP Commercial, responsible for market launch and competitive positioning), and Sara Whitmore (General Counsel, covering FTO and IP clearance topics).
On the GenomeDx side, Helios is likely to seek depositions of Dr. Rajan Mehta (CTO and named inventor on all three patents-in-suit), Dr. Kevin Ostrowski (VP IP and named inventor on the '647 Patent), and potentially Dr. Carolyn Xu (former principal scientist, named inventor on the '271 and '893 Patents). Dr. Xu departed GenomeDx in 2023 and is currently employed by Cascadia Genomics, Inc. She is not under GenomeDx's control, and we will need to coordinate with her directly or through her current employer regarding any deposition. I have flagged this as an action item below.
*Third-Party Subpoena to Corinth Ventures:*
We have drafted — but not yet served — a subpoena duces tecum directed to Corinth Ventures Fund III, LP (Priya Chandrasekaran, Managing Director; 399 Boylston Street, Suite 1100, Boston, MA 02116). The subpoena seeks investment memoranda, due diligence reports, and communications discussing GenomeDx's patent portfolio and Helios's freedom-to-operate analysis. Given the discovery deadline, I recommend we serve this promptly. I would like to discuss timing and strategic considerations with you, Victoria, before proceeding.
---
**VI. Claim Construction Outlook**
The parties exchanged proposed claim construction terms on August 4, 2025. Our preliminary internal analysis, prepared in August 2025, identifies the following key disputed terms: "trained machine-learning classifier," "random-forest classifier," "panel of at least 22 genes selected from a predefined gene set," "risk category," and "composite risk metric."
We are now preparing the Joint Claim Construction and Prehearing Statement for filing pursuant to the Northern District of California Patent Local Rules, in advance of the Markman hearing currently scheduled for September 18, 2026.
The MTD ruling's language regarding "specific, concrete diagnostic improvements" may serve as helpful intrinsic context, though claim construction will turn primarily on the patent specifications, prosecution history, and any relevant extrinsic evidence.
I do want to flag one area requiring careful attention. During prosecution of the '271 Patent, the claims were amended to add specific technical steps — RNA extraction from FFPE samples and reference-gene normalization — to overcome a § 101 rejection. During prosecution of the '893 Patent, the random-forest classifier training methodology was distinguished from the Nakamura reference (U.S. Patent No. 9,617,340). These amendments may limit the scope of the doctrine of equivalents, particularly our DOE theory that Helios's gradient-boosted decision tree is equivalent to the patented random-forest classifier. We are analyzing this issue carefully and will discuss the implications with Dr. Mehta and Dr. Ostrowski before finalizing our claim construction positions.
---
**VII. Expert Engagement**
We are in the process of identifying and retaining both technical and damages experts. Under the current case schedule, opening expert reports are due May 15, 2026, and rebuttal expert reports are due July 10, 2026.
For our technical expert, we are evaluating Dr. Franklin Ogawa, Professor of Computational Oncology at Stanford University, to provide opinions on infringement analysis and validity of the patents-in-suit. A draft engagement letter is in preparation.
For our damages expert, we are evaluating Dr. Louise Tremaine, Managing Director at Ashworth Economics Group LLC (Chicago), to provide lost-profits and reasonable-royalty analysis. A draft engagement letter is likewise in preparation.
We will circulate both engagement letters for your review shortly and schedule a call to discuss expert strategy in detail.
---
**VIII. Damages Framework (Preliminary)**
I want to provide a preliminary overview of our damages framework, particularly for Jonathan's and Pinnacle's awareness as GenomeDx's majority equity holder (62.4%).
*Lost Profits (Primary Theory):* GenomeDx held approximately 74% market share in genomic prostate cancer prognostic testing before ProstaSignal™'s commercial launch on October 7, 2024. Following launch, GenomeDx's market share declined to approximately 68%. We estimate that approximately 6,100 of Helios's roughly 8,400 ProstaSignal™ tests performed during the October 2024 through March 2025 period would have gone to GenomeDx absent the infringement. At GenomeDx's average reimbursement rate of $4,210 per test and an approximately 72% incremental margin, our preliminary lost-profits estimate is approximately $18.5 million for the initial six-month period — and the figure continues to grow as Helios remains in the market.
*Reasonable Royalty (Alternative Theory):* Based on the April 3, 2022 license agreement with Veridian Molecular Labs (15% running royalty on the '271 and '893 Patents for bladder cancer diagnostics, with a $500,000 annual minimum), adjusted upward to 18% to account for the litigation context and the direct competitive overlap in prostate cancer diagnostics, and applied to Helios's estimated ProstaSignal™ revenue of approximately $32.1 million, the reasonable-royalty calculation yields approximately $5.8 million.
In addition to monetary damages, we will pursue a permanent injunction and, if the evidence supports a finding of willfulness, enhanced damages under 35 U.S.C. § 284. A detailed damages analysis will be developed with Dr. Tremaine once she is retained.
---
**IX. Trial Timeline Reminder**
For ease of reference, the key remaining dates in the case schedule are as follows:
- Fact discovery close: March 6, 2026 - Opening expert reports: May 15, 2026 - Rebuttal expert reports: July 10, 2026 - Markman hearing: September 18, 2026 - Trial: February 2027
---
**X. Budget and Fees Update**
As set forth in our March 12, 2025 engagement letter, the estimated budget for this matter through trial is $6.8M–$9.2M. Alan Ngo is sending a detailed billing summary covering fees incurred through Q4 2025 under separate cover.
For reference, current hourly rates for the primary team members are as follows: Catherine Bloom ($1,350/hr), Alan Ngo ($1,275/hr), Peter Vassiliev ($875/hr), and Wendy Schultz ($725/hr).
As a reminder, GenomeDx maintains IP enforcement coverage through Greystone Specialty Insurance Co. (Policy No. GSI-IP-2024-07812), which provides a $10M limit with a $2.5M deductible and 80/20 co-insurance above the deductible. The policy period ended December 31, 2025, and renewal is currently pending. Alan Ngo has sent correspondence to Greystone regarding coverage status, cost reporting, and renewal terms, and we will keep you informed of any developments.
---
**XI. Recommended Next Steps and Action Items**
In light of the foregoing, I recommend we prioritize the following:
1. **Corinth Ventures Subpoena** — We request client authorization and strategic input to serve the subpoena duces tecum on Corinth Ventures Fund III, LP. Given the March 6 discovery cutoff, timing is critical.
2. **Deposition Preparation** — Finalize preparation of GenomeDx's Rule 30(b)(6) designated witnesses (Victoria Sung and Thomas Brennan).
3. **Interrogatory Responses** — Complete and serve GenomeDx's responses to Helios's 17 interrogatories.
4. **Expert Engagement** — Finalize engagement letters for Dr. Ogawa and Dr. Tremaine and circulate for client review.
5. **Dr. Carolyn Xu** — Coordinate with Dr. Xu regarding Helios's potential deposition of her, including outreach through Cascadia Genomics or directly.
6. **Motion to Compel** — Monitor Magistrate Judge Cabrera's ruling on our motion to compel production of the 34 challenged documents.
7. **Strategy Call** — Schedule a call for the week of January 20, 2026, to discuss the above items and broader case strategy in detail.
---
We are in a strong position following the MTD denial, and I am confident in the trajectory of this case. The Court's reasoning validates the approach we have taken from the outset, and it positions us well as we move into the critical discovery, claim construction, and expert phases.
I would welcome the opportunity to schedule a call with you, Victoria, Jonathan, and Kevin at your earliest convenience to walk through these developments and the recommended next steps. In the meantime, Peter Vassiliev and Wendy Schultz are available for any follow-up questions on specific discovery or technical issues.
Thank you for your continued confidence in our team.
Best regards,
**Catherine Bloom** Partner Calderwood & Harkness LLP 555 Mission Street, Suite 3100 San Francisco, CA 94105 T: (415) 555-2800 F: (415) 555-2801 cbloom@calderwoodharkness.com
---
*CONFIDENTIALITY NOTICE: This email and any attachments are attorney-client privileged and/or attorney work product, and are intended solely for the use of the individual(s) to whom it is addressed. This communication contains confidential information. If you are not the intended recipient, you are hereby notified that any review, disclosure, copying, distribution, or use of this communication or any of its contents is strictly prohibited. If you have received this communication in error, please notify the sender immediately by reply email and permanently delete the original and all copies. Thank you.*