UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION
PLAINTIFF GENOME DX THERAPEUTICS INC.'S RESPONSES AND OBJECTIONS TO DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC.'S FIRST SET OF REQUESTS FOR PRODUCTION OF DOCUMENTS (NOS. 1–52)
Date Served: February 26, 2026
I. PRELIMINARY STATEMENT
Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx" or "Plaintiff"), by and through its undersigned attorneys at Calderwood & Harkness LLP, hereby responds and objects to Defendant Helios Precision Diagnostics, Inc.'s ("Helios" or "Defendant") First Set of Requests for Production of Documents, Nos. 1 through 52, served on January 27, 2026, pursuant to Federal Rules of Civil Procedure 26 and 34 and the Local Rules of the United States District Court for the Northern District of California.
These responses and objections are made without waiver of any objections as to the competence, relevance, materiality, privilege, or admissibility of any documents or information produced or identified herein. Nothing contained in these responses or objections shall be deemed an admission by GenomeDx regarding the relevance, authenticity, or admissibility of any document or category of documents, nor shall anything herein be deemed an admission as to any fact, issue, or contention in this litigation.
Plaintiff's responses are based on information reasonably available to GenomeDx as of the date of service of these responses and are subject to supplementation pursuant to Federal Rule of Civil Procedure 26(e). Discovery and investigation in this matter are ongoing, and GenomeDx expressly reserves the right to amend, modify, or supplement these responses and objections as additional information becomes available through continued document review, depositions, expert analysis, or other discovery. GenomeDx has not yet completed its review of all potentially responsive documents, and these responses should not be construed as a representation that GenomeDx's production is complete.
Responsive documents are being produced on a rolling basis through Canfield Document Solutions LLC's RevealIQ platform and are designated in accordance with the Stipulated Protective Order entered by the Court on December 18, 2025 (Dkt. No. 47). Documents are produced as they are kept in the ordinary course of business or, where appropriate, organized to correspond to the categories in Defendant's Requests. All produced documents bear Bates-number prefixes "GDT-" followed by sequential numbering (e.g., GDT-000001).
GenomeDx incorporates by reference each of its General Objections set forth below into each specific response to each individual Request for Production, as though fully stated therein. The assertion of specific objections in response to any individual Request does not constitute a waiver of any General Objection or of any other objection that GenomeDx may later assert.
II. GENERAL OBJECTIONS
GenomeDx makes the following General Objections, each of which is incorporated by reference into each specific response to each individual Request for Production, as though fully set forth therein.
General Objection No. 1 — Scope and Proportionality
GenomeDx objects to each Request to the extent it is overly broad, unduly burdensome, or not proportional to the needs of this case as required by Federal Rule of Civil Procedure 26(b)(1). In evaluating proportionality, GenomeDx has considered, among other factors: the importance of the issues at stake in this action, which involves claims of infringement of U.S. Patent Nos. 10,438,271 (the "'271 Patent"), 11,204,893 (the "'893 Patent"), and 11,891,647 (the "'647 Patent") relating to genomic classifier technology for prostate cancer prognosis; the amount in controversy; the parties' relative access to relevant information; the parties' resources; the importance of the discovery sought in resolving the issues in this case; and whether the burden or expense of the proposed discovery outweighs its likely benefit. GenomeDx has made a good-faith effort to respond to Defendant's Requests in a manner that is both responsive and proportional, and has undertaken reasonable efforts to search for and produce non-privileged responsive documents. To the extent any Request seeks information or documents that are not proportional to the needs of this case, GenomeDx objects to such Request on that basis.
General Objection No. 2 — Attorney-Client Privilege and Work Product
GenomeDx objects to each Request to the extent it calls for or would require the production of documents or communications protected by the attorney-client privilege, the work-product doctrine (including both fact and opinion work product), the joint-defense or common-interest privilege, or any other applicable privilege, immunity, or protection recognized under federal or state law. The inadvertent production of any privileged or protected document shall not constitute a waiver of any privilege or protection, consistent with Federal Rule of Evidence 502(d) and the Stipulated Protective Order entered by this Court on December 18, 2025 (Dkt. No. 47). GenomeDx has implemented a comprehensive privilege review protocol coordinated with its e-discovery vendor, Canfield Document Solutions LLC, utilizing the RevealIQ platform with Technology-Assisted Review ("TAR 2.0") predictive coding workflows specifically configured for privilege screening. This protocol includes iterative training rounds supervised by experienced privilege review attorneys under the direction of Calderwood & Harkness LLP. GenomeDx will identify documents withheld or redacted on the basis of privilege on a privilege log to be served in accordance with Federal Rule of Civil Procedure 26(b)(5)(A) and the Court's scheduling order.
General Objection No. 3 — Vagueness and Ambiguity
GenomeDx objects to each Request to the extent it contains terms that are vague, ambiguous, undefined, or susceptible to multiple reasonable interpretations. Where GenomeDx has responded to a Request despite the presence of vague or ambiguous terms, GenomeDx has interpreted such terms in a reasonable manner and, where applicable, has identified its interpretation in the specific response. GenomeDx's response to any Request containing vague or ambiguous terms should not be construed as an acceptance of Defendant's intended meaning, if different from the interpretation adopted by GenomeDx.
General Objection No. 4 — "All" and "Each" Documents
GenomeDx objects to each Request to the extent it uses the terms "all," "each," "every," or "any" without meaningful limitation as to time period, subject matter, or custodian. Such sweeping requests impose an unreasonable and disproportionate burden on GenomeDx. In responding to Requests that employ such terms, GenomeDx has conducted a reasonable search of documents collected from the eleven (11) identified custodians, as well as relevant shared drives, email repositories, and IT systems, and has produced or will produce non-privileged responsive documents located through that process. GenomeDx does not represent that it has located and produced every document in existence that might conceivably be responsive to any particular Request, but rather that it has undertaken a reasonable and diligent search proportional to the needs of this case.
General Objection No. 5 — Temporal Scope
GenomeDx objects to each Request to the extent it is not limited to a reasonable time period relevant to the claims and defenses asserted in this action. Many of Defendant's Requests contain no temporal limitation whatsoever, which renders them overly broad and unduly burdensome. Unless otherwise stated in a specific response, GenomeDx has limited its search to documents dated or created from January 1, 2014 to the present. This time period encompasses the relevant period for the prosecution, commercialization, and enforcement of the patents-in-suit, as well as the period of Helios's development, regulatory submission, and commercial launch of its ProstaSignal™ Genomic Classifier product. GenomeDx believes this temporal scope is reasonable and proportional to the needs of this case and reserves the right to further narrow or expand this scope as warranted by the specific subject matter of each Request.
General Objection No. 6 — Third-Party Confidential Information
GenomeDx objects to each Request to the extent it seeks documents containing confidential, proprietary, or trade-secret information belonging to third parties. Third parties whose confidential information may be implicated by Defendant's Requests include, but are not limited to, Veridian Molecular Labs, Inc., Pinnacle Biosciences Capital, LP, Ridgeline Health Ventures, Meridian Commercial Bank, N.A., and Whitfield & Garner LLP. GenomeDx will produce such third-party documents, if at all, only under the protections afforded by the Stipulated Protective Order entered December 18, 2025, and subject to any confidentiality obligations GenomeDx owes to such third parties under separate agreements. To the extent GenomeDx is contractually prohibited from disclosing certain third-party information even under a protective order, GenomeDx will identify the nature of such restrictions in its specific responses or privilege log.
General Objection No. 7 — Publicly Available Information
GenomeDx objects to each Request to the extent it seeks documents that are publicly available, including but not limited to published patents and published patent applications available from the United States Patent and Trademark Office, scientific and peer-reviewed publications available through academic databases and journal archives, filings with the Securities and Exchange Commission, publicly available regulatory submissions and determinations, press releases, and documents available on GenomeDx's or other parties' public websites. GenomeDx should not be required to bear the burden of collecting, reviewing, and producing documents that are equally accessible to Defendant through public sources.
General Objection No. 8 — Documents Equally Available to Defendant
GenomeDx objects to each Request to the extent it seeks documents that are in Defendant's own possession, custody, or control, or documents that are equally available to both parties through third-party sources. Requiring GenomeDx to produce documents that Defendant already possesses or can readily obtain from its own files or from public sources is unduly burdensome and not proportional to the needs of this case.
General Objection No. 9 — Duplicative Requests
GenomeDx objects to each Request to the extent it is duplicative of another Request for Production in this set or seeks information already provided by GenomeDx in its Rule 26(a)(1) initial disclosures served July 14, 2025, in its responses to Defendant's interrogatories, or in other discovery responses. Where a Request is substantially duplicative of another Request, GenomeDx may cross-reference its response to the earlier Request rather than providing a separate, redundant production.
General Objection No. 10 — Protective Order Designations
GenomeDx will designate produced documents as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" in accordance with the terms of the two-tier Stipulated Protective Order entered by this Court on December 18, 2025 (Dkt. No. 47). GenomeDx reserves the right to change or upgrade confidentiality designations for any produced document upon written notice to Defendant's counsel, as provided in the Protective Order. The production of any document without a confidentiality designation shall not be deemed a waiver of GenomeDx's right to subsequently designate such document as Confidential or Highly Confidential — Attorneys' Eyes Only.
General Objection No. 11 — Reservation of Rights
GenomeDx's responses to each individual Request for Production are made subject to and without waiver of any and all General Objections stated herein. The assertion of a specific objection in response to any individual Request does not constitute a waiver of any General Objection or any other objection that may later prove applicable. Similarly, the failure to assert a specific objection in response to any individual Request does not constitute a waiver of that objection or any other objection. GenomeDx expressly reserves all rights, objections, privileges, and defenses available to it under the Federal Rules of Civil Procedure, the Federal Rules of Evidence, the Local Rules of this Court, and applicable law.
III. IDENTIFICATION OF CUSTODIANS AND DOCUMENT COLLECTION
In connection with this litigation, GenomeDx has identified eleven (11) custodians for purposes of document collection and review. These custodians were selected based on their roles within GenomeDx, their involvement in the conception, development, prosecution, and commercialization of the patents-in-suit and the Decipher® Prostate genomic classifier test, and their potential knowledge of facts relevant to the claims and defenses in this action. The custodians are as follows:
1. Dr. Rajan Mehta — Chief Technology Officer and Named Inventor on all three patents-in-suit (the '271 Patent, the '893 Patent, and the '647 Patent);
2. Dr. Kevin Ostrowski — Vice President, intellectual Property and Named Inventor on the '647 Patent;
3. Dr. Miriam Langford — Chief Executive Officer;
4. Victoria Sung — General Counsel;
5. Thomas Brennan — Chief Financial Officer;
6. Dr. Carolyn Xu — Former Principal Scientist and Named Inventor on the '271 Patent and the '893 Patent (departed GenomeDx in 2023; currently employed at Cascadia Genomics, Inc.);
7. Dr. Priya Shah — Senior Scientist and Named Inventor on the '647 Patent;
8. Director of Laboratory Operations (identified by functional description to protect individual privacy);
9. Senior Director of Commercial Strategy (identified by functional description);
10. Director of Regulatory Affairs (identified by functional description); and
11. Senior Bioinformatics Scientist (identified by functional description).
Documents were collected from these custodians' email accounts, local and network drives, cloud storage repositories, and relevant enterprise IT systems, including GenomeDx's laboratory information management system (LIMS), document management system, and shared departmental drives. In total, approximately 482,000 documents comprising approximately 1.7 terabytes of data were collected from these custodians and systems.
Following de-duplication, near-duplicate identification, privilege review, and relevance screening using Canfield Document Solutions LLC's RevealIQ platform (employing TAR 2.0 / continuous active learning predictive coding workflows), approximately 218,000 documents have been produced to date in this litigation, bearing Bates numbers GDT-000001 through GDT-218000. These documents have been produced in their native format or as searchable image files (TIFF with extracted text and metadata), as specified in the parties' agreed-upon ESI protocol.
Rolling production is ongoing. Additional documents may be produced as document processing, review, and quality-control procedures are completed. GenomeDx anticipates that its document review will be substantially complete within forty-five (45) days of the date of these responses, subject to the volume and complexity of remaining review tasks.
A privilege log identifying documents withheld on the basis of attorney-client privilege and/or work-product doctrine will be provided in accordance with Federal Rule of Civil Procedure 26(b)(5)(A) and the Stipulated Protective Order. The privilege log is being compiled on a rolling basis and will be supplemented as additional privilege determinations are made during the ongoing document review process.
IV. SPECIFIC RESPONSES AND OBJECTIONS TO REQUESTS FOR PRODUCTION NOS. 1–52
GenomeDx responds to each of Defendant's Requests for Production of Documents as set forth below. Each response incorporates by reference all General Objections stated in Section II above as though fully set forth in each individual response. The assertion of specific objections in response to any individual Request is in addition to, and does not limit, the General Objections. Subject to and without waiver of the foregoing General Objections and any specific objections stated below, GenomeDx responds as follows:
A. Patents-in-Suit and Patent Portfolio (RFP Nos. 1–6)
REQUEST FOR PRODUCTION NO. 1:
All documents relating to the conception, reduction to practice, and development of the inventions claimed in U.S. Patent No. 10,438,271 (the "'271 Patent").
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx specifically objects to this Request as overly broad and not proportional to the needs of this case to the extent it seeks documents relating to the entire '271 Patent, which contains twenty-three (23) claims. Plaintiff's Complaint asserts infringement of Claims 1, 3, 5, 7, 12, and 18 of the '271 Patent. Documents relating to the conception, reduction to practice, and development of subject matter claimed in unasserted claims that is not also relevant to the asserted claims are not proportional to the needs of this case. GenomeDx will therefore limit its production in response to this Request to documents relating to the subject matter of the asserted claims.
GenomeDx further objects to this Request to the extent it seeks documents and communications protected by the attorney-client privilege and/or the work-product doctrine, including but not limited to communications between GenomeDx's inventors and patent prosecution counsel at Calderwood & Harkness LLP and predecessor prosecution counsel regarding the prosecution of the '271 Patent. Such documents will be withheld and identified on GenomeDx's privilege log.
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will produce non-privileged documents responsive to this Request that are located through a reasonable search of the files and records of the identified custodians. Responsive documents include, but are not limited to, laboratory notebooks, research records, experimental protocols and data, internal memoranda and communications, and project management records from the files of Dr. Rajan Mehta, Dr. Carolyn Xu, and Dr. David Petrossian, each of whom is a named inventor on the '271 Patent. Documents responsive to this Request will be designated Confidential or Highly Confidential — Attorneys' Eyes Only under the Stipulated Protective Order, as appropriate, given the highly sensitive nature of GenomeDx's proprietary research and development activities.
REQUEST FOR PRODUCTION NO. 2:
All documents relating to the conception, reduction to practice, and development of the inventions claimed in U.S. Patent No. 11,204,893 (the "'893 Patent").
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx specifically objects to this Request as overly broad and not proportional to the needs of this case to the extent it seeks documents relating to the entirety of the '893 Patent rather than the asserted claims. Plaintiff's Complaint asserts infringement of Claims 1, 2, 9, 14, and 20 of the '893 Patent. GenomeDx will limit its production to documents relating to the subject matter of the asserted claims, including the machine-learning classifier methodologies and gene expression profiling techniques claimed therein.
GenomeDx further objects to this Request to the extent it calls for documents protected by the attorney-client privilege and/or the work-product doctrine, including communications with patent prosecution counsel. Such documents will be withheld and identified on GenomeDx's privilege log.
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will produce non-privileged responsive documents located through a reasonable search of the relevant custodians' files and records. The named inventors on the '893 Patent are Dr. Rajan Mehta and Dr. Carolyn Xu. Responsive documents will include laboratory notebooks, research records, experimental data, internal communications, and related development materials. Documents responsive to this Request will be designated in accordance with the Stipulated Protective Order.
REQUEST FOR PRODUCTION NO. 3:
All documents relating to the conception, reduction to practice, and development of the inventions claimed in U.S. Patent No. 11,891,647 (the "'647 Patent").
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx specifically objects to this Request as overly broad to the extent it extends beyond the subject matter of the asserted claims. Plaintiff's Complaint asserts infringement of Claims 1, 4, 6, 11, and 15 of the '647 Patent. GenomeDx will limit its production accordingly.
GenomeDx further objects to this Request to the extent it calls for privileged communications between GenomeDx's inventors and patent prosecution counsel.
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will produce non-privileged responsive documents located through a reasonable search of the relevant custodians' files and records. The named inventors on the '647 Patent are Dr. Rajan Mehta, Dr. Kevin Ostrowski, and Dr. Priya Shah. Responsive documents include laboratory notebooks, research data, internal communications, and related development materials. GenomeDx will also produce the declaration under 37 C.F.R. § 1.132 submitted by Dr. Rajan Mehta during prosecution of the '647 Patent to the extent such declaration is non-privileged and relates to the conception and reduction to practice of the claimed inventions. Documents responsive to this Request will be designated in accordance with the Stipulated Protective Order.
REQUEST FOR PRODUCTION NO. 4:
The complete prosecution histories, including file wrappers, for U.S. Patent Nos. 10,438,271, 11,204,893, and 11,891,647.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx specifically objects to this Request on the ground that the complete prosecution histories of the patents-in-suit are publicly available from the United States Patent and Trademark Office through its Public Patent Application Information Retrieval (Public PAIR) system and the Patent Center platform. Defendant is equally capable of obtaining these records from public sources and should not impose the burden and expense of compiling and producing these publicly available records on GenomeDx. Notwithstanding this objection, GenomeDx recognizes that its internal copies of the prosecution files may contain non-public documents or annotations and will therefore provide its files to the extent described below.
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will produce copies of the complete file histories for the '271 Patent, the '893 Patent, and the '647 Patent as maintained in GenomeDx's files. This production will include copies of all papers filed with and received from the USPTO, as well as any internal annotations, notes, or non-privileged correspondence with prosecution counsel, to the extent such materials are non-privileged and responsive to this Request. Communications reflecting legal advice or attorney work product will be withheld and identified on GenomeDx's privilege log.
REQUEST FOR PRODUCTION NO. 5:
All documents relating to any other patents or patent applications in the same family as the patents-in-suit, including continuations, continuations-in-part, divisionals, and provisional applications.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx specifically objects to this Request as overly broad and not proportional to the needs of this case. GenomeDx currently holds forty-seven (47) issued U.S. patents, twelve (12) pending U.S. patent applications, and nineteen (19) international family members (including PCT applications, European patents and applications, and counterpart filings in Canada, Japan, Australia, and China). Many of these patents and applications are directed to subject matter unrelated to the claims at issue in this litigation. A request for documents relating to all patents and applications "in the same family as the patents-in-suit" could encompass a substantial portion of GenomeDx's entire patent portfolio and is not proportional to the needs of this case.
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will produce documents relating to patents and patent applications in the direct priority chain of the three patents-in-suit, including the provisional applications from which priority is claimed, any parent applications, and any continuation, continuation-in-part, or divisional applications directly derived from the same parent applications. This includes documents relating to the terminal disclaimer filed over the '271 Patent and the '893 Patent during the prosecution of the '647 Patent. GenomeDx will not produce documents relating to distantly related family members or foreign counterparts absent a particularized showing of relevance by Defendant.
REQUEST FOR PRODUCTION NO. 6:
All documents relating to any reexamination, inter partes review, post-grant review, or other post-issuance proceeding before the United States Patent and Trademark Office or any foreign patent office involving any of the patents-in-suit.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
RESPONSE:
Subject to and without waiver of the foregoing General Objections, GenomeDx responds that, as of the date of this response, no reexamination, inter partes review, post-grant review, or other post-issuance proceeding has been initiated before the United States Patent and Trademark Office or any foreign patent office involving any of the three patents-in-suit or their foreign counterparts. GenomeDx will supplement this response pursuant to Federal Rule of Civil Procedure 26(e) if any such proceeding is initiated during the pendency of this litigation.
B. Decipher® Test and Accused Technology Comparison (RFP Nos. 7–14)
REQUEST FOR PRODUCTION NO. 7:
All documents describing the design, development, and operation of GenomeDx's Decipher® Prostate genomic classifier test.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx specifically objects to this Request as overly broad and unduly burdensome. The Decipher® Prostate genomic classifier test has been in continuous commercial use since approximately 2013 and has been the subject of extensive research, development, clinical validation, regulatory engagement, and commercial activity over more than a decade. A request for "all documents" relating to the "design, development, and operation" of the Decipher® test, without any temporal limitation or subject matter refinement, would encompass hundreds of thousands of documents spanning the entire history of GenomeDx's principal commercial product and is not proportional to the needs of this patent infringement case.
GenomeDx will limit its production in response to this Request to documents reasonably relevant to the infringement and damages claims asserted in this action, including documents describing the test methodology, gene panel composition (the 22-gene panel), classifier design and architecture, sample processing protocols, and clinical validation, to the extent such documents are relevant to the claim construction issues and infringement contentions in this case.
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will produce non-privileged responsive documents describing the design, development, and operation of the Decipher® Prostate genomic classifier test, including technical specifications, test methodology descriptions, gene panel documentation, classifier algorithm descriptions, standard operating procedures, and internal presentations describing the test's operation and clinical utility. Given the highly sensitive and proprietary nature of this information, which includes trade-secret and competitively sensitive technical details, responsive documents will be designated Highly Confidential — Attorneys' Eyes Only under the Stipulated Protective Order.
REQUEST FOR PRODUCTION NO. 8:
All documents identifying the specific genes included in the Decipher® Prostate genomic classifier gene panel.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx specifically objects to this Request to the extent the identity and specific combination of genes in the Decipher® gene panel constitute trade-secret information of GenomeDx. GenomeDx will produce responsive documents subject to the protections of the Stipulated Protective Order.
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will produce documents identifying the twenty-two (22) genes included in the Decipher® Prostate genomic classifier gene panel, including gene names, identifiers (e.g., GenBank accession numbers, Affymetrix probe set identifiers), and descriptions of the biological pathways represented by the gene panel. These documents will be designated Highly Confidential — Attorneys' Eyes Only under the Stipulated Protective Order given the proprietary and trade-secret nature of GenomeDx's gene selection and combination.
REQUEST FOR PRODUCTION NO. 9:
All documents relating to the machine-learning classifier algorithms used in the Decipher® test, including training data, feature selection methodology, model architecture, and validation studies.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx specifically objects to this Request as overly broad and as seeking GenomeDx's core trade secrets and proprietary information. The machine-learning classifier algorithms, training data, feature selection methodology, and model architecture underlying the Decipher® test represent the culmination of years of research and development and hundreds of millions of dollars in investment by GenomeDx and its equity investors. The Request as drafted would require production of virtually every technical document relating to GenomeDx's most commercially valuable intellectual property. GenomeDx further objects that this Request is not proportional to the needs of this case to the extent it seeks granular algorithmic details, raw training data, and source code beyond what is reasonably necessary for claim construction and infringement analysis.
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will produce documents sufficient to show the classifier methodology at a level of detail reasonably relevant to claim construction and infringement analysis in this case. This production will include descriptions of the random-forest classifier methodology employed in the Decipher® test, information regarding the training cohort (including the cohort of at least 500 patient samples as referenced in the specification of the '893 Patent), feature selection methodology descriptions, and validation study summaries. GenomeDx will not produce raw training data sets in their entirety absent a specific showing of need. To the extent Defendant seeks inspection of source code implementing the classifier algorithms, GenomeDx will make such source code available for inspection under Highly Confidential — Attorneys' Eyes Only terms at GenomeDx's San Diego, California headquarters, in a secure, stand-alone review environment, subject to reasonable scheduling and access protocols to be agreed upon by the parties.
REQUEST FOR PRODUCTION NO. 10:
All documents comparing the Decipher® test with the ProstaSignal™ Genomic Classifier or any other competing genomic prostate cancer test.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx objects to this Request to the extent it seeks documents reflecting attorney-client privileged communications or attorney work product, including legal analyses comparing the Decipher® and ProstaSignal™ tests in the context of patent infringement analysis or litigation strategy.
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will produce non-privileged responsive documents comparing the Decipher® test with the ProstaSignal™ Genomic Classifier or other competing genomic prostate cancer tests, including internal competitive analyses, market intelligence reports, product comparison matrices, and business presentations prepared by GenomeDx personnel. Documents reflecting legal strategy, litigation analysis, or attorney-client privileged communications regarding infringement theories will be withheld and identified on GenomeDx's privilege log.
REQUEST FOR PRODUCTION NO. 11:
All documents relating to GenomeDx's knowledge of or investigation into the ProstaSignal™ Genomic Classifier prior to the filing of this action.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx specifically objects to this Request to the extent it seeks documents constituting attorney-client privileged communications or attorney work product. GenomeDx's pre-filing investigation of the ProstaSignal™ Genomic Classifier was conducted by and at the direction of Calderwood & Harkness LLP for the purpose of evaluating potential patent infringement claims and preparing for this litigation. Documents reflecting that investigation, including legal analyses, attorney memoranda, and related communications, are protected by the attorney-client privilege and the work-product doctrine and will not be produced.
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will produce non-privileged business documents reflecting GenomeDx's awareness of the ProstaSignal™ Genomic Classifier, including marketing intelligence reports, competitive surveillance materials, scientific conference materials and poster presentations, published literature reviews, press clippings, and internal business communications discussing ProstaSignal™ as a competitive product. Documents constituting privileged pre-filing investigation materials will be withheld and identified on GenomeDx's privilege log.
REQUEST FOR PRODUCTION NO. 12:
All documents relating to GenomeDx's analysis of whether the ProstaSignal™ test infringes any of the patents-in-suit.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx specifically objects to this Request in its entirety as calling for documents protected by the attorney-client privilege and the work-product doctrine. GenomeDx's analysis of whether the ProstaSignal™ test infringes the patents-in-suit was performed by and at the direction of its legal counsel at Calderwood & Harkness LLP for the express purpose of providing legal advice regarding potential patent infringement claims and in anticipation of this litigation. Such analyses constitute core attorney work product reflecting counsel's mental impressions, conclusions, opinions, and legal theories, and are entitled to the highest level of protection under the work-product doctrine. See Fed. R. Civ. P. 26(b)(3)(B).
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will not produce privileged infringement analyses prepared by or at the direction of counsel. To the extent any non-privileged technical comparisons of the Decipher® and ProstaSignal™ tests exist in GenomeDx's files that were prepared for business purposes independent of litigation or legal advice, GenomeDx will produce such documents. GenomeDx's formal infringement contentions have been served pursuant to the Court's Patent Local Rules and provide Defendant with GenomeDx's claim-by-claim infringement theories.
REQUEST FOR PRODUCTION NO. 13:
All documents relating to the "predefined gene set" referenced in Claim 1 of the '271 Patent.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
RESPONSE:
Subject to and without waiver of the foregoing General Objections, GenomeDx will produce non-privileged documents identifying and describing the "predefined gene set" as that term is used in Claim 1 of the '271 Patent, including patent specification disclosures describing the gene set, supporting research data reflecting the selection and validation of the predefined gene set, and laboratory records documenting the development and refinement of the gene set. GenomeDx notes that the specification of the '271 Patent itself provides substantial disclosure regarding the predefined gene set, and GenomeDx's claim construction position regarding this term is set forth in its claim construction brief filed January 5, 2026 (Dkt. No. 62).
REQUEST FOR PRODUCTION NO. 14:
All documents relating to GenomeDx's FDA De Novo classification application for the Decipher® test.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx specifically objects to this Request as overly broad and not proportional to the needs of this patent infringement case. The De Novo classification application for the Decipher® Prostate genomic classifier test was submitted to the U.S. Food and Drug Administration on August 15, 2024, and constitutes a voluminous regulatory submission containing extensive clinical, analytical, and manufacturing data. The vast majority of this data is not relevant to the patent infringement claims or defenses at issue in this litigation. Requiring production of the entire De Novo application would be unduly burdensome and disproportionate.
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will produce a summary of the De Novo classification application, including documents describing the test methodology, analytical validation data, and clinical performance data submitted to the FDA, to the extent such documents are reasonably relevant to the technology at issue in this patent infringement case. Documents produced in response to this Request will be designated Highly Confidential — Attorneys' Eyes Only under the Stipulated Protective Order given the highly proprietary nature of regulatory submissions. GenomeDx will not produce the entirety of the FDA De Novo application absent a Court order based on a particularized showing of specific relevance and need by Defendant.
C. Licensing and Royalties (RFP Nos. 15–20)
REQUEST FOR PRODUCTION NO. 15:
All license agreements, term sheets, or other agreements granting rights under any of the patents-in-suit.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
RESPONSE:
Subject to and without waiver of the foregoing General Objections, GenomeDx will produce the following:
The non-exclusive license agreement dated April 3, 2022, between GenomeDx (as licensor) and Veridian Molecular Labs, Inc. (as licensee) (the "Veridian License Agreement"), pursuant to which GenomeDx granted Veridian a non-exclusive license under the '271 Patent and the '893 Patent for use in the field of bladder cancer diagnostics. The material terms of the Veridian License Agreement include a fifteen percent (15%) running royalty rate on net sales of licensed products, a minimum annual royalty of five hundred thousand dollars ($500,000), and a term co-extensive with the life of the licensed patents. The Veridian License Agreement will be produced in its entirety, designated Highly Confidential — Attorneys' Eyes Only under the Stipulated Protective Order.
GenomeDx is not aware of any other license agreements, term sheets, or other agreements granting rights under any of the three patents-in-suit. GenomeDx will supplement this response pursuant to Rule 26(e) if any additional responsive agreements are identified.
REQUEST FOR PRODUCTION NO. 16:
All documents relating to negotiations, drafts, or communications concerning any license agreement identified in response to RFP No. 15.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx specifically objects to this Request to the extent it seeks documents protected by the attorney-client privilege and/or the work-product doctrine. Certain communications and documents generated during the negotiation of the Veridian License Agreement were conducted by or at the direction of GenomeDx's legal counsel and reflect legal advice regarding the scope, terms, and structure of the license.
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will produce non-privileged drafts of the Veridian License Agreement, redline versions, term sheets, and business communications between GenomeDx and Veridian Molecular Labs, Inc. relating to the negotiation of the Veridian License Agreement, to the extent such documents are non-privileged. All documents produced in response to this Request will be designated Highly Confidential — Attorneys' Eyes Only under the Stipulated Protective Order. Privileged communications will be withheld and identified on GenomeDx's privilege log.
REQUEST FOR PRODUCTION NO. 17:
All documents relating to royalty payments received under any license agreement identified in response to RFP No. 15.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
RESPONSE:
Subject to and without waiver of the foregoing General Objections, GenomeDx will produce royalty payment records and royalty accountings received from Veridian Molecular Labs, Inc. under the Veridian License Agreement dated April 3, 2022, including royalty statements, payment records, and any correspondence relating to royalty calculations or adjustments. Documents produced in response to this Request will be designated Confidential under the Stipulated Protective Order.
REQUEST FOR PRODUCTION NO. 18:
All documents relating to any offers to license, demands for licensing fees, or licensing discussions with any third party concerning the patents-in-suit.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx specifically objects to this Request to the extent it seeks documents reflecting licensing discussions conducted by or at the direction of legal counsel, which may constitute attorney-client privileged communications or attorney work product.
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will produce non-privileged documents responsive to this Request. As of the date of this response, GenomeDx is not aware of licensing discussions with parties other than Veridian Molecular Labs, Inc. and Helios Precision Diagnostics, Inc. relating specifically to the patents-in-suit. GenomeDx will supplement this response if additional responsive documents are identified during its ongoing document review.
REQUEST FOR PRODUCTION NO. 19:
All documents relating to any offer to license the patents-in-suit to Helios or any communication with Helios regarding the patents-in-suit prior to the filing of the Complaint in this action.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx specifically objects to this Request to the extent it seeks documents reflecting pre-suit communications that constitute attorney-client privileged communications or attorney work product. Pre-suit licensing and enforcement communications with Helios were conducted by and at the direction of GenomeDx's legal counsel and may reflect litigation strategy, legal analysis, and settlement considerations.
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will produce non-privileged pre-suit correspondence with Helios regarding the patents-in-suit, if any such non-privileged correspondence exists. Privileged communications, including cease-and-desist correspondence prepared by counsel, pre-suit licensing demand letters reflecting legal analysis, and related internal communications reflecting litigation strategy, will be withheld and identified on GenomeDx's privilege log.
REQUEST FOR PRODUCTION NO. 20:
All documents relating to GenomeDx's patent licensing program, policies, or strategies generally.
SPECIFIC OBJECTIONS:
GenomeDx incorporates by reference each of its General Objections as though fully stated herein.
GenomeDx specifically objects to this Request as overly broad and not proportional to the needs of this case. GenomeDx holds a portfolio of forty-seven (47) issued U.S. patents, twelve (12) pending U.S. patent applications, and nineteen (19) international family members covering a range of genomic diagnostic technologies. GenomeDx's licensing policies and strategies regarding its entire patent portfolio—including patents directed to technologies unrelated to the genomic prostate cancer classifier technology at issue in this case—are not relevant to the infringement, validity, or damages issues presented and are not proportional to the needs of this litigation.
RESPONSE:
Subject to and without waiver of the foregoing General and Specific Objections, GenomeDx will produce documents relating to its licensing strategy for the patents-in-suit and the genomic classifier patent family of which the patents-in-suit are a part, to the extent such documents are non-privileged and relevant to the damages theories asserted in this case. GenomeDx will not produce documents relating to licensing programs, policies, or strategies for its broader patent portfolio.
D. Financial and Damages Information (RFP Nos. 21–30)
REQUEST FOR PRODUCTION NO. 21:
All documents relating to GenomeDx's revenues, costs, and profits from the Decipher® Prostate test for fiscal years 2020 through 2025.