1013-00005 · Genome Dx Therapeutics Inc · Pleadings

answer-to-counterclaims.docx DOCUMENT Litigation

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UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA

Plaintiff and Counterclaim Defendant Genome Dx Therapeutics Inc. ("GenomeDx" or "GDT"), by and through its attorneys of record, Calderwood & Harkness LLP, hereby answers the Counterclaims of Defendant and Counterclaim Plaintiff Helios Precision Diagnostics, Inc. ("Helios"), filed on May 12, 2025 (Dkt. No. 38), as follows. GenomeDx responds to each numbered paragraph of Helios's Counterclaims. To the extent any allegation contained in Helios's Counterclaims is not expressly admitted herein, it is denied. GenomeDx reserves the right to amend this Answer as warranted by the facts and circumstances as they develop through the course of discovery and further proceedings.

GENERAL DENIAL

GenomeDx denies each and every allegation in Helios's Counterclaims that is not expressly admitted herein. To the extent Helios's Counterclaims contain allegations that are vague, ambiguous, or susceptible to more than one reasonable interpretation, GenomeDx denies each such allegation to the extent it purports to state facts inconsistent with GenomeDx's understanding of the relevant events, documents, and circumstances.

RESPONSES TO COUNTERCLAIM ALLEGATIONS

A. Responses to Jurisdictional and Venue Allegations

1. GenomeDx admits that this Court has subject matter jurisdiction over the patent-related claims and counterclaims asserted in this action pursuant to 28 U.S.C. §§ 1331 and 1338(a), which confer original jurisdiction on federal district courts over civil actions arising under the patent laws of the United States.

2. GenomeDx admits that, to the extent Helios seeks a declaratory judgment of non-infringement, invalidity, or unenforceability of the patents-in-suit, the Declaratory Judgment Act, 28 U.S.C. §§ 2201–2202, provides a procedural mechanism by which this Court may adjudicate such claims, and GenomeDx does not contest that an actual controversy exists between the parties within the meaning of the Declaratory Judgment Act sufficient to confer jurisdiction. GenomeDx denies, however, that Helios is entitled to any of the declaratory relief it seeks.

3. GenomeDx admits that venue is proper in the Northern District of California pursuant to 28 U.S.C. §§ 1391 and 1400(b).

4. GenomeDx admits that Helios is subject to personal jurisdiction in this judicial district, based upon, among other things, Helios's systematic and continuous business activities in the State of California, including the operation of a CLIA-certified laboratory in San Diego, California, and the marketing, sale, and performance of its ProstaSignal™ Genomic Classifier test within this district.

B. Responses to Party Allegations

5. GenomeDx admits that it is a corporation organized and existing under the laws of the State of Delaware, with its principal place of business at 4750 Torrey Pines Road, Suite 300, San Diego, California 92130, and that it is qualified to do business in the State of California.

6. GenomeDx admits that Helios is a corporation organized and existing under the laws of the State of Delaware, with its principal place of business at 200 CambridgePark Drive, Suite 600, Cambridge, Massachusetts 02140, and that Helios is qualified to do business in the Commonwealth of Massachusetts and the State of California. GenomeDx further admits that Helios operates a CLIA-certified clinical laboratory located at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121.

7. GenomeDx admits that it is the owner by assignment of all right, title, and interest in and to U.S. Patent No. 10,438,271 ("the '271 Patent"), U.S. Patent No. 11,204,893 ("the '893 Patent"), and U.S. Patent No. 11,891,647 ("the '647 Patent") (collectively, the "patents-in-suit"), and that GenomeDx holds the exclusive right to enforce those patents and to collect damages for any infringement thereof.

8. GenomeDx denies any allegation, characterization, or implication contained in Helios's Counterclaims that any of the patents-in-suit is invalid, unenforceable, or not infringed by Helios's products, services, or activities. Each of the patents-in-suit was duly and lawfully issued by the United States Patent and Trademark Office ("USPTO") after full and thorough examination, and each is entitled to a presumption of validity under 35 U.S.C. § 282.

C. Responses to Allegations Regarding the Patents-in-Suit

Regarding U.S. Patent No. 10,438,271 ("the '271 Patent").

9. GenomeDx admits that U.S. Patent No. 10,438,271 is titled "Methods for Predicting Prostate Cancer Outcomes Using Multi-Gene Expression Classifiers," that the application leading to the '271 Patent was filed on June 14, 2016, and that the '271 Patent was duly issued by the USPTO on October 8, 2019.

10. GenomeDx admits that the named inventors of the '271 Patent are Dr. Rajan Mehta, Dr. Carolyn Xu, and Dr. David Petrossian.

11. GenomeDx admits that in the present action it asserts Claims 1, 3, 5, 7, 12, and 18 of the '271 Patent against Helios.

12. GenomeDx denies any allegation that the '271 Patent or any asserted claim thereof is invalid, unenforceable, or otherwise not entitled to full patent protection under the laws of the United States. The '271 Patent speaks for itself, and any characterization of the '271 Patent, its claims, its specification, or its prosecution history that is inconsistent with the patent document as issued is denied.

Regarding U.S. Patent No. 11,204,893 ("the '893 Patent").

13. GenomeDx admits that U.S. Patent No. 11,204,893 is titled "Genomic Classifier Systems and Methods for Post-Surgical Cancer Prognosis," that the application leading to the '893 Patent was filed on March 22, 2019, as a continuation of the application that issued as the '271 Patent and is part of the same patent family, and that the '893 Patent was duly issued by the USPTO on December 21, 2021.

14. GenomeDx admits that the named inventors of the '893 Patent are Dr. Rajan Mehta and Dr. Carolyn Xu.

15. GenomeDx admits that in the present action it asserts Claims 1, 2, 9, 14, and 20 of the '893 Patent against Helios.

16. GenomeDx denies any allegation that the '893 Patent or any asserted claim thereof is invalid, unenforceable, or otherwise not entitled to full patent protection. The '893 Patent speaks for itself, and any characterization of the '893 Patent, its claims, its specification, or its prosecution history that is inconsistent with the patent document as issued is denied.

Regarding U.S. Patent No. 11,891,647 ("the '647 Patent").

17. GenomeDx admits that U.S. Patent No. 11,891,647 is titled "Improved Methods for Genomic Risk Stratification in Prostate Cancer Using Combined Biomarker and Clinical Variable Models," that the application leading to the '647 Patent was filed on September 9, 2021, and that the '647 Patent was duly issued by the USPTO on February 6, 2024.

18. GenomeDx admits that the named inventors of the '647 Patent are Dr. Rajan Mehta, Dr. Kevin Ostrowski, and Dr. Priya Shah.

19. GenomeDx admits that in the present action it asserts Claims 1, 4, 6, 11, and 15 of the '647 Patent against Helios.

20. GenomeDx denies any allegation that the '647 Patent or any asserted claim thereof is invalid, unenforceable, or otherwise not entitled to full patent protection. The '647 Patent speaks for itself, and any characterization of the '647 Patent, its claims, its specification, or its prosecution history that is inconsistent with the patent document as issued is denied.

21. GenomeDx denies any allegation that the terminal disclaimer filed during prosecution of the '647 Patent over the '271 and '893 Patents affects the validity of any asserted claim of the '647 Patent. The terminal disclaimer was filed to overcome a non-substantive double-patenting rejection and does not constitute an admission regarding the scope or validity of any claim of any patent-in-suit.

D. Responses to Allegations Regarding Prosecution History

22. GenomeDx states that the prosecution histories of the '271, '893, and '647 Patents are public records maintained by the USPTO that speak for themselves. GenomeDx denies any characterization of the prosecution histories that is incomplete, misleading, or otherwise inconsistent with the actual contents of those prosecution records.

23. Regarding the prosecution of the '271 Patent, GenomeDx acknowledges that the Examiner initially raised a rejection under 35 U.S.C. § 101 based on the framework set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), and Alice Corp. Pty. Ltd. v. CLS Bank International, 573 U.S. 208 (2014). GenomeDx further acknowledges that the applicant amended the claims to recite specific technical steps, including the extraction of RNA from formalin-fixed paraffin-embedded ("FFPE") tissue samples and normalization of expression data using a defined reference-gene panel, and that the Examiner thereafter withdrew the § 101 rejection and allowed the claims. GenomeDx denies any implication by Helios that these amendments rendered the claims of the '271 Patent invalid or narrowed their scope beyond the plain language of the claims as issued. The amendments were made to clarify what was already inherent in the original disclosure and to address the Examiner's initial concerns regarding patent eligibility.

24. Regarding the prosecution of the '893 Patent, GenomeDx acknowledges that the Examiner raised a rejection under 35 U.S.C. § 102 based on Nakamura et al. (U.S. Patent No. 9,617,340) and that the applicant overcame that rejection by distinguishing the random-forest classifier training methodology and minimum cohort size recited in the claims from what was disclosed in Nakamura. GenomeDx denies any implication by Helios that this prosecution history limits the scope of the '893 Patent claims beyond the plain language thereof. The claims of the '893 Patent are to be construed according to their ordinary and customary meaning as understood by a person of ordinary skill in the art, informed by the specification and prosecution history as a whole.

25. Regarding the prosecution of the '647 Patent, GenomeDx acknowledges that the Examiner raised rejections under 35 U.S.C. § 103 based on combinations of Nakamura et al. and Gagnon (WO 2018/065413), and that the applicant overcame those rejections through, among other things, a declaration under 37 C.F.R. § 1.132 submitted by Dr. Rajan Mehta, which established unexpected results achieved by the combined genomic-clinical model claimed in the '647 Patent as compared to genomic-only models known in the prior art. GenomeDx denies any implication by Helios that the manner in which the § 103 rejections were overcome during prosecution affects the validity or enforceability of the asserted claims of the '647 Patent.

E. Responses to Allegations Regarding GenomeDx's Products

26. GenomeDx admits that it markets and sells the Decipher® Prostate genomic classifier test, which is a clinical-grade diagnostic assay that utilizes a 22-gene expression panel to assess the risk of metastasis in men with prostate cancer following radical prostatectomy.

27. GenomeDx admits that it obtained Multianalyte Assays with Algorithmic Analyses ("MAAA") code 0047M from the American Medical Association for the Decipher® test in 2018, and that this code is used for billing and reimbursement purposes.

28. GenomeDx admits that the Decipher® test is performed as a laboratory-developed test ("LDT") under the Clinical Laboratory Improvement Amendments ("CLIA") regulatory framework, consistent with standard industry practice for genomic diagnostic assays.

29. GenomeDx admits that it submitted a De Novo classification request to the U.S. Food and Drug Administration ("FDA") on August 15, 2024, regarding the Decipher® test, and that such application remains pending before the FDA as of the date of this Answer.

30. GenomeDx denies any allegation by Helios that characterizes GenomeDx's commercial activities, marketing practices, licensing strategies, or enforcement of its intellectual property rights as anticompetitive, monopolistic, or otherwise improper under the antitrust laws, unfair competition laws, or any other body of law. GenomeDx's business activities are lawful in all respects, and GenomeDx's enforcement of its valid patent rights in this action is protected by law.

F. Responses to Allegations Regarding Helios's ProstaSignal™ Product

31. GenomeDx admits that Helios commercially launched its ProstaSignal™ Genomic Classifier on or about October 7, 2024.

32. GenomeDx admits that, based on publicly available information, ProstaSignal™ uses a 24-gene expression panel to assess prostate cancer prognosis.

33. GenomeDx admits that Helios obtained MAAA code 0239M for ProstaSignal™ from the American Medical Association in September 2024.

34. GenomeDx states that it lacks sufficient knowledge or information to admit or deny allegations regarding the internal workings, proprietary algorithms, specific computational methodologies, validation datasets, or other technical details of the ProstaSignal™ test that have not been publicly disclosed or produced in discovery, and on that basis denies such allegations. GenomeDx reserves the right to amend its responses to such allegations as additional information becomes available through the discovery process.

35. GenomeDx denies that ProstaSignal™ does not infringe the patents-in-suit. As set forth in GenomeDx's Complaint (Dkt. No. 1) and as will be demonstrated through discovery and at trial, Helios's ProstaSignal™ Genomic Classifier practices each and every limitation of the asserted claims of the '271, '893, and '647 Patents, either literally or under the doctrine of equivalents.

RESPONSES TO COUNTERCLAIM COUNTS

Response to Count I: Declaratory Judgment of Non-Infringement of the '271 Patent

36. GenomeDx denies that Helios is entitled to a declaration of non-infringement of any asserted claim of U.S. Patent No. 10,438,271. GenomeDx incorporates by reference each and every admission, denial, and averment set forth above as though fully restated herein.

37. GenomeDx denies that Helios's ProstaSignal™ Genomic Classifier does not practice any element of Claims 1, 3, 5, 7, 12, or 18 of the '271 Patent. To the contrary, GenomeDx avers that ProstaSignal™ performs each step and satisfies each limitation recited in the asserted claims of the '271 Patent, including, without limitation, the use of a trained machine-learning classifier applied to a multi-gene expression panel derived from FFPE prostate tumor tissue to classify patients into risk categories for cancer recurrence and metastasis.

38. GenomeDx specifically denies Helios's contention that the use of a 24-gene expression panel in ProstaSignal™ avoids infringement of the '271 Patent. The asserted claims of the '271 Patent recite the measurement of expression levels of "at least 22 genes" from a defined panel. A 24-gene expression panel satisfies the "at least 22 genes" limitation. Helios's argument to the contrary lacks any basis in claim construction or patent law.

39. GenomeDx further denies Helios's contention that the use of a gradient-boosted decision tree classifier in ProstaSignal™ avoids infringement of the '271 Patent claims reciting a "trained machine-learning classifier." The claims of the '271 Patent are not limited to any particular type or implementation of machine-learning classifier. A gradient-boosted decision tree is a type of trained machine-learning classifier that falls squarely within the scope of the claim language.

Response to Count II: Declaratory Judgment of Non-Infringement of the '893 Patent

40. GenomeDx denies that Helios is entitled to a declaration of non-infringement of any asserted claim of U.S. Patent No. 11,204,893. GenomeDx incorporates by reference each and every admission, denial, and averment set forth above as though fully restated herein.

41. GenomeDx denies that Helios's ProstaSignal™ Genomic Classifier does not practice any element of Claims 1, 2, 9, 14, or 20 of the '893 Patent. GenomeDx avers that, to the extent any limitation of the '893 Patent claims—including the recitation of a "random-forest classifier"—is not literally met by Helios's use of a gradient-boosted decision tree classifier, infringement nonetheless exists under the doctrine of equivalents. Helios's gradient-boosted decision tree classifier performs substantially the same function as the claimed random-forest classifier (i.e., combining predictions from multiple decision trees to produce a robust classification output), in substantially the same way (i.e., through ensemble learning methods that aggregate the outputs of multiple weak learners trained on patient gene-expression data), to achieve substantially the same result (i.e., a numerical prognostic score correlated with metastasis risk that classifies patients into clinically actionable risk categories). The differences between a random-forest classifier and a gradient-boosted decision tree classifier are insubstantial within the meaning of the doctrine of equivalents.

42. GenomeDx denies that ProstaSignal™ does not normalize gene-expression data derived from FFPE prostate tissue samples using a reference gene panel. Based on publicly available information regarding the ProstaSignal™ test, including Helios's published technical white papers and its MAAA code application materials, ProstaSignal™ performs normalization of raw gene-expression data using reference housekeeping genes, consistent with the limitations of the '893 Patent claims.

43. GenomeDx denies that ProstaSignal™ does not output a numerical prognostic score correlated with the risk of metastasis within five years following radical prostatectomy. Based on available information, ProstaSignal™ generates a "ProstaScore" that is a numerical value on a continuous scale intended to predict the probability of metastatic progression within a defined time horizon, satisfying this claim limitation.

Response to Count III: Declaratory Judgment of Non-Infringement of the '647 Patent

44. GenomeDx denies that Helios is entitled to a declaration of non-infringement of any asserted claim of U.S. Patent No. 11,891,647. GenomeDx incorporates by reference each and every admission, denial, and averment set forth above as though fully restated herein.

45. GenomeDx denies that Helios's ProstaSignal™ Genomic Classifier does not practice any element of Claims 1, 4, 6, 11, or 15 of the '647 Patent. GenomeDx avers that ProstaSignal™ combines its ProstaScore genomic risk score with clinical covariates—specifically, Gleason grade group and pre-operative prostate-specific antigen ("PSA") level—to generate a composite risk metric that is transmitted to ordering healthcare providers via clinical reports. These clinical covariates are specifically identified in the asserted claims of the '647 Patent, and ProstaSignal™'s integration of genomic and clinical data to produce a composite risk output satisfies the limitations of the asserted claims. Based on publicly available information, including Helios's marketing materials, published validation study abstracts, and sample clinical reports, ProstaSignal™ performs each step of the claimed method.

Response to Count IV: Declaratory Judgment of Invalidity of the '271 Patent Under 35 U.S.C. § 101

46. GenomeDx denies that any asserted claim of the '271 Patent is invalid under 35 U.S.C. § 101 as lacking patent-eligible subject matter. GenomeDx incorporates by reference each and every admission, denial, and averment set forth above as though fully restated herein.

47. GenomeDx denies that the asserted claims of the '271 Patent are directed to abstract ideas, laws of nature, or natural phenomena. The claims of the '271 Patent are directed to specific, concrete diagnostic improvements in the field of prostate cancer prognosis, including particular technical steps that go well beyond any abstract idea or natural correlation. Specifically, the asserted claims recite: (a) obtaining a biological sample comprising tumor tissue from a patient who has undergone radical prostatectomy; (b) extracting RNA from the biological sample, including from FFPE tissue; (c) measuring expression levels of at least 22 specified genes from a defined panel; (d) normalizing the measured expression levels using a reference gene panel; (e) applying a trained machine-learning classifier to the normalized expression data; and (f) classifying the patient into a risk category based on the output of the classifier. These steps, individually and as an ordered combination, constitute a patent-eligible application of any underlying natural phenomena or abstract concepts.

48. GenomeDx avers that the asserted claims of the '271 Patent are distinguishable from the claims at issue in 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). Unlike the claims in Mayo, which recited only the observation of a natural correlation between drug metabolite levels and therapeutic efficacy, and unlike the claims in Myriad, which claimed naturally occurring DNA sequences, the '271 Patent claims recite a specific, multi-step diagnostic method employing particular laboratory techniques and computational tools to arrive at a clinically actionable classification. The claims are more akin to those upheld as patent-eligible in Rapid Litigation Management Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016), and Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018).

49. GenomeDx further states that the USPTO examined the claims of the '271 Patent under § 101, initially raised a rejection on patent-eligibility grounds, and subsequently withdrew that rejection after the applicant demonstrated that the claims recited patent-eligible subject matter. The '271 Patent claims are therefore entitled to a presumption of validity under 35 U.S.C. § 282, which Helios must overcome by clear and convincing evidence.

Response to Count V: Declaratory Judgment of Invalidity of the '893 Patent Under 35 U.S.C. § 101

50. GenomeDx denies that any asserted claim of the '893 Patent is invalid under 35 U.S.C. § 101. GenomeDx incorporates by reference each and every admission, denial, and averment set forth in its responses to Counts I through IV above, including its responses to Count IV, as though fully restated herein.

51. GenomeDx avers that the asserted claims of the '893 Patent recite specific technical limitations that, individually and as an ordered combination, render the claims patent-eligible. These limitations include, without limitation: (a) normalization of gene-expression data from FFPE prostate tissue using a defined reference gene panel; (b) input of the normalized expression data into a random-forest classifier that has been trained on a cohort of at least 500 patient samples with known clinical outcomes; and (c) output of a numerical prognostic score on a continuous scale correlated with the risk of metastasis within five years. These steps constitute a patent-eligible improvement in the diagnostic arts. They are not directed merely to an abstract idea or natural phenomenon, but rather to a specific and practical method of processing biological data through defined computational and laboratory techniques to produce a clinically useful diagnostic output.

52. GenomeDx denies that the inclusion of machine-learning classification methodology renders the claims of the '893 Patent abstract. The machine-learning classifier recited in the claims is not an end in itself but is integrated into a specific diagnostic method that transforms raw biological data into actionable clinical information through a series of defined technical steps.

Response to Count VI: Declaratory Judgment of Invalidity of the '647 Patent Under 35 U.S.C. § 101

53. GenomeDx denies that any asserted claim of the '647 Patent is invalid under 35 U.S.C. § 101. GenomeDx incorporates by reference each and every admission, denial, and averment set forth in its responses to Counts I through V above, as though fully restated herein.

54. GenomeDx avers that the asserted claims of the '647 Patent recite an integrated method that combines genomic data with clinical data to generate a composite risk metric for post-prostatectomy cancer prognosis. This integration of genomic and clinical variables represents a specific, practical application of any underlying natural relationship between gene expression and clinical outcomes. The claims do not merely observe a natural correlation; they prescribe a defined method of combining particular types of data through a trained computational model to generate a composite output that goes beyond what any individual data type or any individual clinical variable could provide. The claims thus recite patent-eligible subject matter under § 101.

55. GenomeDx notes that this Court, in its Order dated January 13, 2026, denied Helios's Motion to Dismiss GenomeDx's infringement claims (Counts II and III of GenomeDx's Complaint) on § 101 grounds, finding that Helios's patent-eligibility challenges were premature in the absence of full claim construction. That ruling is relevant to the question of whether Helios's § 101 invalidity counterclaims can be adjudicated at this stage and supports GenomeDx's position that the § 101 issues require full development of the factual record through claim construction and discovery.

Response to Count VII: Declaratory Judgment of Invalidity of the '271 Patent Under 35 U.S.C. § 102

56. GenomeDx denies that any asserted claim of the '271 Patent is anticipated by any prior art reference under 35 U.S.C. § 102, including Nakamura et al. (U.S. Patent No. 9,617,340) or any other reference identified or relied upon by Helios. GenomeDx incorporates by reference each and every admission, denial, and averment set forth above as though fully restated herein.

57. GenomeDx avers that Nakamura et al. does not disclose each and every element of any asserted claim of the '271 Patent, arranged as claimed. Without conceding the relevance or materiality of Nakamura to the asserted claims, GenomeDx states that Nakamura discloses a different gene panel, a different classification methodology, and a different clinical application than those recited in the '271 Patent claims. The '271 Patent claims are entitled to a presumption of validity under 35 U.S.C. § 282, which presumption Helios must overcome by clear and convincing evidence. See Kestrel Partners LLC v. i4i Ltd. P'ship, 564 U.S. 91 (2011).

58. GenomeDx denies that any other prior art reference not yet identified by Helios anticipates the asserted claims of the '271 Patent, and reserves the right to respond to any additional prior art references identified by Helios during the course of discovery and in accordance with any scheduling orders entered by the Court.

Response to Count VIII: Declaratory Judgment of Invalidity Under 35 U.S.C. § 103

59. GenomeDx denies that any asserted claim of any patent-in-suit is obvious under 35 U.S.C. § 103 in view of any combination of prior art references, whether taken individually or in combination. GenomeDx incorporates by reference each and every admission, denial, and averment set forth above as though fully restated herein.

60. GenomeDx specifically denies that the asserted claims of any patent-in-suit would have been obvious in view of Nakamura et al. (U.S. Patent No. 9,617,340), Gagnon (WO 2018/065413), Thornberry et al. ("Ensemble Machine Learning Methods for Predicting Cancer Recurrence," Journal of Computational Oncology, Vol. 14, No. 3, pp. 287–301, March 2015), and Klein et al. ("A Genomic Classifier Improves Prediction of Metastatic Disease Within 5 Years After Surgery in Node-Negative High-Risk Prostate Cancer," European Urology, Vol. 66, No. 1, pp. 45–52, 2014), whether considered individually or in any combination.

61. GenomeDx avers that the prior art identified by Helios does not teach or suggest the specific combinations of features recited in the asserted claims of the patents-in-suit. A person of ordinary skill in the art at the time of the inventions would not have been motivated to combine these references in the manner alleged by Helios to arrive at the claimed inventions, and even if motivated to combine such references, would not have had a reasonable expectation of success in achieving the specific technical results claimed. Helios's obviousness theory rests on impermissible hindsight reconstruction of the claimed inventions.

62. GenomeDx further avers that objective indicia of non-obviousness—so-called "secondary considerations"—strongly support the validity of the asserted claims. These secondary considerations include, without limitation:

(a) Commercial success: The Decipher® Prostate genomic classifier test, which practices the claimed inventions, has achieved extraordinary commercial success. In fiscal year 2024, GenomeDx generated revenue of $387.6 million from the Decipher® test, representing a compound annual growth rate exceeding 30% since the test's commercial launch. The Decipher® test is the market-leading post-prostatectomy genomic classifier in the United States and is used by thousands of urologists and oncologists to guide treatment decisions for prostate cancer patients.

(b) Industry acclaim: The Decipher® test and the underlying inventions claimed in the patents-in-suit have received widespread recognition in the medical and scientific communities, including endorsement in clinical practice guidelines issued by the National Comprehensive Cancer Network ("NCCN"), the American Urological Association ("AUA"), and the American Society of Clinical Oncology ("ASCO").

(c) Copying by competitors: Helios's ProstaSignal™ Genomic Classifier is a close copy of the methods claimed in the patents-in-suit, employing a substantially similar multi-gene expression panel, machine-learning classification approach, and integrated genomic-clinical risk stratification methodology. Helios's decision to develop a product that practices the patented methods, rather than designing around the patents, is probative evidence of non-obviousness.

(d) Long-felt but unmet need: Prior to the inventions claimed in the patents-in-suit, there existed a long-felt but unmet need in the field of prostate cancer treatment for reliable post-prostatectomy prognostic tools that could predict the risk of metastasis with sufficient accuracy to guide adjuvant therapy decisions. The claimed inventions addressed that unmet need by providing a validated, reproducible, and clinically actionable genomic classification method.

63. GenomeDx further avers that, during prosecution of the '647 Patent, Dr. Rajan Mehta submitted a declaration under 37 C.F.R. § 1.132 establishing that the combined genomic-clinical model claimed in the '647 Patent achieved unexpected and superior results compared to genomic-only models and clinical-variable-only models, including statistically significant improvements in the area under the receiver operating characteristic curve ("AUC") for five-year metastasis prediction. This declaration was credited by the USPTO Examiner in withdrawing the § 103 rejections and allowing the claims. The unexpected results demonstrated by Dr. Mehta's declaration constitute additional evidence of non-obviousness.

Response to Count IX: Declaratory Judgment of Unenforceability

64. GenomeDx denies that any patent-in-suit is unenforceable for any reason, including, without limitation, inequitable conduct, unclean hands, or patent misuse. GenomeDx incorporates by reference each and every admission, denial, and averment set forth above as though fully restated herein.

65. GenomeDx denies that it, any named inventor of any patent-in-suit, or any person involved in the prosecution of any patent-in-suit engaged in any fraud, misrepresentation, material omission, or other misconduct before the USPTO during the prosecution of any application that issued as a patent-in-suit. All individuals involved in the prosecution of the patents-in-suit acted in good faith and in compliance with their duties of candor and good faith under 37 C.F.R. § 1.56.

66. GenomeDx avers that all material prior art known to the applicants and their representatives was disclosed to the USPTO during prosecution, as reflected in the Information Disclosure Statements ("IDS") filed in each application. The prosecution histories of the patents-in-suit demonstrate full and complete compliance with the duty of disclosure.

67. GenomeDx denies any allegation that it has engaged in unclean hands, patent misuse, or any other conduct that would render any patent-in-suit unenforceable. GenomeDx has not attempted to extend the scope of its patent rights beyond the claims as issued, has not tied its patent licenses to unpatented products or services, and has not otherwise engaged in any anticompetitive conduct in connection with the patents-in-suit.

AFFIRMATIVE DEFENSES TO COUNTERCLAIMS

GenomeDx asserts the following affirmative defenses to Helios's Counterclaims without assuming the burden of proof on any issue for which the burden properly rests with Helios.

First Affirmative Defense: Failure to State a Claim

Helios's Counterclaims, and each of them, fail to state a claim upon which relief can be granted under Federal Rule of Civil Procedure 12(b)(6). Helios has not alleged facts sufficient to establish that it is entitled to any of the declaratory relief it seeks, and its legal theories are insufficient as a matter of law to support the relief requested.

Second Affirmative Defense: Presumption of Validity

Each of the patents-in-suit—U.S. Patent Nos. 10,438,271, 11,204,893, and 11,891,647—was duly and lawfully issued by the United States Patent and Trademark Office after thorough examination, including consideration of prior art and patent-eligibility requirements. Under 35 U.S.C. § 282, each patent-in-suit is entitled to a presumption of validity, and Helios bears the burden of proving invalidity by clear and convincing evidence. See Kestrel Partners LLC v. i4i Ltd. P'ship, 564 U.S. 91, 95 (2011). Helios cannot meet this burden.

Third Affirmative Defense: Prosecution History Supports Validity

The prosecution histories of the '271, '893, and '647 Patents demonstrate that the USPTO considered and rejected the same or substantially similar invalidity arguments now raised by Helios in its Counterclaims. Specifically, the USPTO considered and overcame § 101 subject-matter eligibility challenges during prosecution of the '271 Patent, § 102 anticipation arguments based on Nakamura et al. during prosecution of the '893 Patent, and § 103 obviousness arguments based on combinations of Nakamura et al. and Gagnon during prosecution of the '647 Patent. Helios's recycled invalidity theories, which are largely identical to the arguments already considered and rejected by the USPTO, are entitled to diminished weight and do not overcome the presumption of validity.

Fourth Affirmative Defense: Patent Eligibility Under § 101

The asserted claims of all three patents-in-suit are directed to patent-eligible subject matter under 35 U.S.C. § 101. The claims recite specific, concrete diagnostic methods with particular technical steps—including RNA extraction, gene-expression measurement, data normalization, machine-learning classification, and risk stratification—that constitute improvements in the art of genomic cancer prognosis. The claims are not directed to abstract ideas, laws of nature, or natural phenomena, and they satisfy both steps of the patent-eligibility framework set forth in Alice Corp. Pty. Ltd. v. CLS Bank International, 573 U.S. 208 (2014), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).

Fifth Affirmative Defense: No Anticipation

No single prior art reference, including Nakamura et al. (U.S. Patent No. 9,617,340) or any other reference identified or relied upon by Helios, discloses each and every limitation of any asserted claim of any patent-in-suit, arranged as claimed. The asserted claims are therefore not anticipated under 35 U.S.C. § 102.

Sixth Affirmative Defense: Non-Obviousness

The claimed inventions of the patents-in-suit are non-obvious in view of the prior art under 35 U.S.C. § 103. The specific combination of features recited in the asserted claims is not taught or suggested by any prior art reference or combination of references identified by Helios. Moreover, objective indicia of non-obviousness strongly support the validity of the asserted claims, including: (a) the extraordinary commercial success of the Decipher® Prostate genomic classifier test, which generated revenue of $387.6 million in fiscal year 2024; (b) widespread industry recognition and endorsement of the Decipher® test in major clinical practice guidelines; (c) copying of the claimed methods by Helios and other competitors; (d) the long-felt but unmet need for reliable post-prostatectomy prognostic tools; and (e) unexpected results demonstrated by the combined genomic-clinical model of the '647 Patent. The prior art does not provide any teaching, suggestion, or motivation to combine references in the manner alleged by Helios, and Helios's obviousness arguments rest on impermissible hindsight analysis.

Seventh Affirmative Defense: Enforceability

The patents-in-suit are enforceable. There has been no inequitable conduct, fraud, misrepresentation, or material omission before the USPTO in connection with the prosecution of any patent-in-suit. All material information known to the applicants and their counsel was disclosed to the USPTO in compliance with the duty of candor under 37 C.F.R. § 1.56. Helios's unenforceability counterclaim is without merit and fails to satisfy the heightened pleading standard applicable to inequitable conduct claims under Brightmoor & Co., Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc).

Eighth Affirmative Defense: Infringement

Helios's ProstaSignal™ Genomic Classifier infringes the asserted claims of all three patents-in-suit, either literally or under the doctrine of equivalents, as set forth in GenomeDx's Complaint (Dkt. No. 1). Helios's counterclaims for declaratory judgment of non-infringement of the '271, '893, and '647 Patents are without merit and should be denied. The evidence will demonstrate that ProstaSignal™ practices each and every limitation of the asserted claims, and Helios's non-infringement arguments are based on distinctions without a difference.

Ninth Affirmative Defense: Waiver, Estoppel, and Laches

To the extent applicable, Helios's counterclaims may be barred, in whole or in part, by the doctrines of waiver, estoppel, and/or laches. GenomeDx reserves the right to develop the factual basis for these defenses through discovery.

Tenth Affirmative Defense: Reservation of Defenses

GenomeDx reserves the right to assert additional affirmative defenses as discovery progresses and additional facts are developed. Discovery in this action is ongoing, and GenomeDx has not yet had the opportunity to review all relevant documents and information in Helios's possession, custody, or control. GenomeDx expressly reserves the right to amend this Answer to assert additional affirmative defenses as may be warranted by the facts and circumstances revealed through discovery, consistent with Federal Rule of Civil Procedure 15 and any applicable scheduling orders.

PRAYER FOR RELIEF

WHEREFORE, Plaintiff and Counterclaim Defendant Genome Dx Therapeutics Inc. respectfully requests that this Court enter judgment as follows:

1. Denying and dismissing each and every one of Helios's Counterclaims in their entirety, with prejudice, and awarding Helios no relief thereon;

2. Declaring that Helios has infringed, and continues to infringe, the asserted claims of U.S. Patent Nos. 10,438,271, 11,204,893, and 11,891,647 through its manufacture, use, sale, offer for sale, and importation of the ProstaSignal™ Genomic Classifier and related products and services;

3. Declaring that all asserted claims of U.S. Patent Nos. 10,438,271, 11,204,893, and 11,891,647 are valid and enforceable;

4. Awarding GenomeDx damages adequate to compensate for Helios's past and ongoing infringement of the patents-in-suit, including lost profits and/or a reasonable royalty, in an amount to be determined at trial, together with prejudgment and post-judgment interest at the maximum rate allowed by law;

5. Awarding GenomeDx enhanced damages up to three times the amount of compensatory damages pursuant to 35 U.S.C. § 284, in the event Helios's infringement is found to be willful;

6. Issuing a permanent injunction pursuant to 35 U.S.C. § 283 restraining and enjoining Helios, its officers, agents, servants, employees, attorneys, affiliates, subsidiaries, and all persons acting in concert or participation with Helios, from further infringement of the patents-in-suit;

7. Awarding GenomeDx its reasonable attorneys' fees and costs incurred in this action pursuant to 35 U.S.C. § 285, in the event the Court finds this to be an exceptional case;

8. Awarding GenomeDx its costs of suit herein; and

9. Awarding GenomeDx such other and further relief as this Court deems just and proper.

JURY DEMAND

Plaintiff and Counterclaim Defendant Genome Dx Therapeutics Inc. hereby demands a trial by jury on all issues so triable in this action, including all claims and counterclaims, pursuant to Federal Rule of Civil Procedure 38.

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

By: ________

Catherine Bloom (CA Bar No. 247831)

Alan Ngo (CA Bar No. 289654) Peter Vassiliev (CA Bar No. 302417) Wendy Schultz (CA Bar No. 314209)

555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 773-6200 Facsimile: (415) 773-6201

Email: cbloom@calderwoodharkness.com

Attorneys for Plaintiff and Counterclaim Defendant Genome Dx Therapeutics Inc.

Dated: May 30, 2025

CERTIFICATE OF SERVICE

I, Catherine Bloom, hereby certify that on May 30, 2025, I caused a true and correct copy of the foregoing PLAINTIFF AND COUNTERCLAIM DEFENDANT GENOME DX THERAPEUTICS INC.'S ANSWER TO DEFENDANT AND COUNTERCLAIM PLAINTIFF HELIOS PRECISION DIAGNOSTICS, INC.'S COUNTERCLAIMS to be served on all counsel of record via the Court's CM/ECF electronic filing system, which will send notification of such filing to the following:

Marcus Pellegrini Danielle Forrest Owen Chu RIDGECREST DURNEVAL LLP One Federal Street, Suite 3400 Boston, Massachusetts 02110

and

350 South Grand Avenue, Suite 2800 Los Angeles, California 90071

Attorneys for Defendant and Counterclaim Plaintiff Helios Precision Diagnostics, Inc.

By: ________

Catherine Bloom

GENOME DX THERAPEUTICS INC.,	Case No. 3:25-cv-01847-JWL
Plaintiff and Counterclaim Defendant,	Hon. Jessica W. Langston
v.	PLAINTIFF AND COUNTERCLAIM DEFENDANT GENOME DX THERAPEUTICS INC.'S ANSWER TO DEFENDANT AND COUNTERCLAIM PLAINTIFF HELIOS PRECISION DIAGNOSTICS, INC.'S COUNTERCLAIMS

HELIOS PRECISION DIAGNOSTICS, INC.,

Defendant and Counterclaim Plaintiff.

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA
Plaintiff and Counterclaim Defendant Genome Dx Therapeutics Inc. ("GenomeDx" or "GDT"), by and through its attorneys of record, Calderwood & Harkness LLP, hereby answers the Counterclaims of Defendant and Counterclaim Plaintiff Helios Precision Diagnostics, Inc. ("Helios"), filed on May 12, 2025 (Dkt. No. 38), as follows. GenomeDx responds to each numbered paragraph of Helios's Counterclaims. To the extent any allegation contained in Helios's Counterclaims is not expressly admitted herein, it is denied. GenomeDx reserves the right to amend this Answer as warranted by the facts and circumstances as they develop through the course of discovery and further proceedings.
GENERAL DENIAL
GenomeDx denies each and every allegation in Helios's Counterclaims that is not expressly admitted herein. To the extent Helios's Counterclaims contain allegations that are vague, ambiguous, or susceptible to more than one reasonable interpretation, GenomeDx denies each such allegation to the extent it purports to state facts inconsistent with GenomeDx's understanding of the relevant events, documents, and circumstances.
RESPONSES TO COUNTERCLAIM ALLEGATIONS
A. Responses to Jurisdictional and Venue Allegations
1. GenomeDx admits that this Court has subject matter jurisdiction over the patent-related claims and counterclaims asserted in this action pursuant to 28 U.S.C. §§ 1331 and 1338(a), which confer original jurisdiction on federal district courts over civil actions arising under the patent laws of the United States.
2. GenomeDx admits that, to the extent Helios seeks a declaratory judgment of non-infringement, invalidity, or unenforceability of the patents-in-suit, the Declaratory Judgment Act, 28 U.S.C. §§ 2201–2202, provides a procedural mechanism by which this Court may adjudicate such claims, and GenomeDx does not contest that an actual controversy exists between the parties within the meaning of the Declaratory Judgment Act sufficient to confer jurisdiction. GenomeDx denies, however, that Helios is entitled to any of the declaratory relief it seeks.
3. GenomeDx admits that venue is proper in the Northern District of California pursuant to 28 U.S.C. §§ 1391 and 1400(b).
4. GenomeDx admits that Helios is subject to personal jurisdiction in this judicial district, based upon, among other things, Helios's systematic and continuous business activities in the State of California, including the operation of a CLIA-certified laboratory in San Diego, California, and the marketing, sale, and performance of its ProstaSignal™ Genomic Classifier test within this district.
B. Responses to Party Allegations
5. GenomeDx admits that it is a corporation organized and existing under the laws of the State of Delaware, with its principal place of business at 4750 Torrey Pines Road, Suite 300, San Diego, California 92130, and that it is qualified to do business in the State of California.
6. GenomeDx admits that Helios is a corporation organized and existing under the laws of the State of Delaware, with its principal place of business at 200 CambridgePark Drive, Suite 600, Cambridge, Massachusetts 02140, and that Helios is qualified to do business in the Commonwealth of Massachusetts and the State of California. GenomeDx further admits that Helios operates a CLIA-certified clinical laboratory located at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121.
7. GenomeDx admits that it is the owner by assignment of all right, title, and interest in and to U.S. Patent No. 10,438,271 ("the '271 Patent"), U.S. Patent No. 11,204,893 ("the '893 Patent"), and U.S. Patent No. 11,891,647 ("the '647 Patent") (collectively, the "patents-in-suit"), and that GenomeDx holds the exclusive right to enforce those patents and to collect damages for any infringement thereof.
8. GenomeDx denies any allegation, characterization, or implication contained in Helios's Counterclaims that any of the patents-in-suit is invalid, unenforceable, or not infringed by Helios's products, services, or activities. Each of the patents-in-suit was duly and lawfully issued by the United States Patent and Trademark Office ("USPTO") after full and thorough examination, and each is entitled to a presumption of validity under 35 U.S.C. § 282.
C. Responses to Allegations Regarding the Patents-in-Suit
Regarding U.S. Patent No. 10,438,271 ("the '271 Patent").
9. GenomeDx admits that U.S. Patent No. 10,438,271 is titled "Methods for Predicting Prostate Cancer Outcomes Using Multi-Gene Expression Classifiers," that the application leading to the '271 Patent was filed on June 14, 2016, and that the '271 Patent was duly issued by the USPTO on October 8, 2019.
10. GenomeDx admits that the named inventors of the '271 Patent are Dr. Rajan Mehta, Dr. Carolyn Xu, and Dr. David Petrossian.
11. GenomeDx admits that in the present action it asserts Claims 1, 3, 5, 7, 12, and 18 of the '271 Patent against Helios.
12. GenomeDx denies any allegation that the '271 Patent or any asserted claim thereof is invalid, unenforceable, or otherwise not entitled to full patent protection under the laws of the United States. The '271 Patent speaks for itself, and any characterization of the '271 Patent, its claims, its specification, or its prosecution history that is inconsistent with the patent document as issued is denied.
Regarding U.S. Patent No. 11,204,893 ("the '893 Patent").
13. GenomeDx admits that U.S. Patent No. 11,204,893 is titled "Genomic Classifier Systems and Methods for Post-Surgical Cancer Prognosis," that the application leading to the '893 Patent was filed on March 22, 2019, as a continuation of the application that issued as the '271 Patent and is part of the same patent family, and that the '893 Patent was duly issued by the USPTO on December 21, 2021.
14. GenomeDx admits that the named inventors of the '893 Patent are Dr. Rajan Mehta and Dr. Carolyn Xu.
15. GenomeDx admits that in the present action it asserts Claims 1, 2, 9, 14, and 20 of the '893 Patent against Helios.
16. GenomeDx denies any allegation that the '893 Patent or any asserted claim thereof is invalid, unenforceable, or otherwise not entitled to full patent protection. The '893 Patent speaks for itself, and any characterization of the '893 Patent, its claims, its specification, or its prosecution history that is inconsistent with the patent document as issued is denied.
Regarding U.S. Patent No. 11,891,647 ("the '647 Patent").
17. GenomeDx admits that U.S. Patent No. 11,891,647 is titled "Improved Methods for Genomic Risk Stratification in Prostate Cancer Using Combined Biomarker and Clinical Variable Models," that the application leading to the '647 Patent was filed on September 9, 2021, and that the '647 Patent was duly issued by the USPTO on February 6, 2024.
18. GenomeDx admits that the named inventors of the '647 Patent are Dr. Rajan Mehta, Dr. Kevin Ostrowski, and Dr. Priya Shah.
19. GenomeDx admits that in the present action it asserts Claims 1, 4, 6, 11, and 15 of the '647 Patent against Helios.
20. GenomeDx denies any allegation that the '647 Patent or any asserted claim thereof is invalid, unenforceable, or otherwise not entitled to full patent protection. The '647 Patent speaks for itself, and any characterization of the '647 Patent, its claims, its specification, or its prosecution history that is inconsistent with the patent document as issued is denied.
21. GenomeDx denies any allegation that the terminal disclaimer filed during prosecution of the '647 Patent over the '271 and '893 Patents affects the validity of any asserted claim of the '647 Patent. The terminal disclaimer was filed to overcome a non-substantive double-patenting rejection and does not constitute an admission regarding the scope or validity of any claim of any patent-in-suit.
D. Responses to Allegations Regarding Prosecution History
22. GenomeDx states that the prosecution histories of the '271, '893, and '647 Patents are public records maintained by the USPTO that speak for themselves. GenomeDx denies any characterization of the prosecution histories that is incomplete, misleading, or otherwise inconsistent with the actual contents of those prosecution records.
23. Regarding the prosecution of the '271 Patent, GenomeDx acknowledges that the Examiner initially raised a rejection under 35 U.S.C. § 101 based on the framework set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), and Alice Corp. Pty. Ltd. v. CLS Bank International, 573 U.S. 208 (2014). GenomeDx further acknowledges that the applicant amended the claims to recite specific technical steps, including the extraction of RNA from formalin-fixed paraffin-embedded ("FFPE") tissue samples and normalization of expression data using a defined reference-gene panel, and that the Examiner thereafter withdrew the § 101 rejection and allowed the claims. GenomeDx denies any implication by Helios that these amendments rendered the claims of the '271 Patent invalid or narrowed their scope beyond the plain language of the claims as issued. The amendments were made to clarify what was already inherent in the original disclosure and to address the Examiner's initial concerns regarding patent eligibility.
24. Regarding the prosecution of the '893 Patent, GenomeDx acknowledges that the Examiner raised a rejection under 35 U.S.C. § 102 based on Nakamura et al. (U.S. Patent No. 9,617,340) and that the applicant overcame that rejection by distinguishing the random-forest classifier training methodology and minimum cohort size recited in the claims from what was disclosed in Nakamura. GenomeDx denies any implication by Helios that this prosecution history limits the scope of the '893 Patent claims beyond the plain language thereof. The claims of the '893 Patent are to be construed according to their ordinary and customary meaning as understood by a person of ordinary skill in the art, informed by the specification and prosecution history as a whole.
25. Regarding the prosecution of the '647 Patent, GenomeDx acknowledges that the Examiner raised rejections under 35 U.S.C. § 103 based on combinations of Nakamura et al. and Gagnon (WO 2018/065413), and that the applicant overcame those rejections through, among other things, a declaration under 37 C.F.R. § 1.132 submitted by Dr. Rajan Mehta, which established unexpected results achieved by the combined genomic-clinical model claimed in the '647 Patent as compared to genomic-only models known in the prior art. GenomeDx denies any implication by Helios that the manner in which the § 103 rejections were overcome during prosecution affects the validity or enforceability of the asserted claims of the '647 Patent.
E. Responses to Allegations Regarding GenomeDx's Products
26. GenomeDx admits that it markets and sells the Decipher® Prostate genomic classifier test, which is a clinical-grade diagnostic assay that utilizes a 22-gene expression panel to assess the risk of metastasis in men with prostate cancer following radical prostatectomy.
27. GenomeDx admits that it obtained Multianalyte Assays with Algorithmic Analyses ("MAAA") code 0047M from the American Medical Association for the Decipher® test in 2018, and that this code is used for billing and reimbursement purposes.
28. GenomeDx admits that the Decipher® test is performed as a laboratory-developed test ("LDT") under the Clinical Laboratory Improvement Amendments ("CLIA") regulatory framework, consistent with standard industry practice for genomic diagnostic assays.
29. GenomeDx admits that it submitted a De Novo classification request to the U.S. Food and Drug Administration ("FDA") on August 15, 2024, regarding the Decipher® test, and that such application remains pending before the FDA as of the date of this Answer.
30. GenomeDx denies any allegation by Helios that characterizes GenomeDx's commercial activities, marketing practices, licensing strategies, or enforcement of its intellectual property rights as anticompetitive, monopolistic, or otherwise improper under the antitrust laws, unfair competition laws, or any other body of law. GenomeDx's business activities are lawful in all respects, and GenomeDx's enforcement of its valid patent rights in this action is protected by law.
F. Responses to Allegations Regarding Helios's ProstaSignal™ Product
31. GenomeDx admits that Helios commercially launched its ProstaSignal™ Genomic Classifier on or about October 7, 2024.
32. GenomeDx admits that, based on publicly available information, ProstaSignal™ uses a 24-gene expression panel to assess prostate cancer prognosis.
33. GenomeDx admits that Helios obtained MAAA code 0239M for ProstaSignal™ from the American Medical Association in September 2024.
34. GenomeDx states that it lacks sufficient knowledge or information to admit or deny allegations regarding the internal workings, proprietary algorithms, specific computational methodologies, validation datasets, or other technical details of the ProstaSignal™ test that have not been publicly disclosed or produced in discovery, and on that basis denies such allegations. GenomeDx reserves the right to amend its responses to such allegations as additional information becomes available through the discovery process.
35. GenomeDx denies that ProstaSignal™ does not infringe the patents-in-suit. As set forth in GenomeDx's Complaint (Dkt. No. 1) and as will be demonstrated through discovery and at trial, Helios's ProstaSignal™ Genomic Classifier practices each and every limitation of the asserted claims of the '271, '893, and '647 Patents, either literally or under the doctrine of equivalents.
RESPONSES TO COUNTERCLAIM COUNTS
Response to Count I: Declaratory Judgment of Non-Infringement of the '271 Patent
36. GenomeDx denies that Helios is entitled to a declaration of non-infringement of any asserted claim of U.S. Patent No. 10,438,271. GenomeDx incorporates by reference each and every admission, denial, and averment set forth above as though fully restated herein.
37. GenomeDx denies that Helios's ProstaSignal™ Genomic Classifier does not practice any element of Claims 1, 3, 5, 7, 12, or 18 of the '271 Patent. To the contrary, GenomeDx avers that ProstaSignal™ performs each step and satisfies each limitation recited in the asserted claims of the '271 Patent, including, without limitation, the use of a trained machine-learning classifier applied to a multi-gene expression panel derived from FFPE prostate tumor tissue to classify patients into risk categories for cancer recurrence and metastasis.
38. GenomeDx specifically denies Helios's contention that the use of a 24-gene expression panel in ProstaSignal™ avoids infringement of the '271 Patent. The asserted claims of the '271 Patent recite the measurement of expression levels of "at least 22 genes" from a defined panel. A 24-gene expression panel satisfies the "at least 22 genes" limitation. Helios's argument to the contrary lacks any basis in claim construction or patent law.
39. GenomeDx further denies Helios's contention that the use of a gradient-boosted decision tree classifier in ProstaSignal™ avoids infringement of the '271 Patent claims reciting a "trained machine-learning classifier." The claims of the '271 Patent are not limited to any particular type or implementation of machine-learning classifier. A gradient-boosted decision tree is a type of trained machine-learning classifier that falls squarely within the scope of the claim language.
Response to Count II: Declaratory Judgment of Non-Infringement of the '893 Patent
40. GenomeDx denies that Helios is entitled to a declaration of non-infringement of any asserted claim of U.S. Patent No. 11,204,893. GenomeDx incorporates by reference each and every admission, denial, and averment set forth above as though fully restated herein.
41. GenomeDx denies that Helios's ProstaSignal™ Genomic Classifier does not practice any element of Claims 1, 2, 9, 14, or 20 of the '893 Patent. GenomeDx avers that, to the extent any limitation of the '893 Patent claims—including the recitation of a "random-forest classifier"—is not literally met by Helios's use of a gradient-boosted decision tree classifier, infringement nonetheless exists under the doctrine of equivalents. Helios's gradient-boosted decision tree classifier performs substantially the same function as the claimed random-forest classifier (i.e., combining predictions from multiple decision trees to produce a robust classification output), in substantially the same way (i.e., through ensemble learning methods that aggregate the outputs of multiple weak learners trained on patient gene-expression data), to achieve substantially the same result (i.e., a numerical prognostic score correlated with metastasis risk that classifies patients into clinically actionable risk categories). The differences between a random-forest classifier and a gradient-boosted decision tree classifier are insubstantial within the meaning of the doctrine of equivalents.
42. GenomeDx denies that ProstaSignal™ does not normalize gene-expression data derived from FFPE prostate tissue samples using a reference gene panel. Based on publicly available information regarding the ProstaSignal™ test, including Helios's published technical white papers and its MAAA code application materials, ProstaSignal™ performs normalization of raw gene-expression data using reference housekeeping genes, consistent with the limitations of the '893 Patent claims.
43. GenomeDx denies that ProstaSignal™ does not output a numerical prognostic score correlated with the risk of metastasis within five years following radical prostatectomy. Based on available information, ProstaSignal™ generates a "ProstaScore" that is a numerical value on a continuous scale intended to predict the probability of metastatic progression within a defined time horizon, satisfying this claim limitation.
Response to Count III: Declaratory Judgment of Non-Infringement of the '647 Patent
44. GenomeDx denies that Helios is entitled to a declaration of non-infringement of any asserted claim of U.S. Patent No. 11,891,647. GenomeDx incorporates by reference each and every admission, denial, and averment set forth above as though fully restated herein.
45. GenomeDx denies that Helios's ProstaSignal™ Genomic Classifier does not practice any element of Claims 1, 4, 6, 11, or 15 of the '647 Patent. GenomeDx avers that ProstaSignal™ combines its ProstaScore genomic risk score with clinical covariates—specifically, Gleason grade group and pre-operative prostate-specific antigen ("PSA") level—to generate a composite risk metric that is transmitted to ordering healthcare providers via clinical reports. These clinical covariates are specifically identified in the asserted claims of the '647 Patent, and ProstaSignal™'s integration of genomic and clinical data to produce a composite risk output satisfies the limitations of the asserted claims. Based on publicly available information, including Helios's marketing materials, published validation study abstracts, and sample clinical reports, ProstaSignal™ performs each step of the claimed method.
Response to Count IV: Declaratory Judgment of Invalidity of the '271 Patent Under 35 U.S.C. § 101
46. GenomeDx denies that any asserted claim of the '271 Patent is invalid under 35 U.S.C. § 101 as lacking patent-eligible subject matter. GenomeDx incorporates by reference each and every admission, denial, and averment set forth above as though fully restated herein.
47. GenomeDx denies that the asserted claims of the '271 Patent are directed to abstract ideas, laws of nature, or natural phenomena. The claims of the '271 Patent are directed to specific, concrete diagnostic improvements in the field of prostate cancer prognosis, including particular technical steps that go well beyond any abstract idea or natural correlation. Specifically, the asserted claims recite: (a) obtaining a biological sample comprising tumor tissue from a patient who has undergone radical prostatectomy; (b) extracting RNA from the biological sample, including from FFPE tissue; (c) measuring expression levels of at least 22 specified genes from a defined panel; (d) normalizing the measured expression levels using a reference gene panel; (e) applying a trained machine-learning classifier to the normalized expression data; and (f) classifying the patient into a risk category based on the output of the classifier. These steps, individually and as an ordered combination, constitute a patent-eligible application of any underlying natural phenomena or abstract concepts.
48. GenomeDx avers that the asserted claims of the '271 Patent are distinguishable from the claims at issue in 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). Unlike the claims in Mayo, which recited only the observation of a natural correlation between drug metabolite levels and therapeutic efficacy, and unlike the claims in Myriad, which claimed naturally occurring DNA sequences, the '271 Patent claims recite a specific, multi-step diagnostic method employing particular laboratory techniques and computational tools to arrive at a clinically actionable classification. The claims are more akin to those upheld as patent-eligible in Rapid Litigation Management Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016), and Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018).
49. GenomeDx further states that the USPTO examined the claims of the '271 Patent under § 101, initially raised a rejection on patent-eligibility grounds, and subsequently withdrew that rejection after the applicant demonstrated that the claims recited patent-eligible subject matter. The '271 Patent claims are therefore entitled to a presumption of validity under 35 U.S.C. § 282, which Helios must overcome by clear and convincing evidence.
Response to Count V: Declaratory Judgment of Invalidity of the '893 Patent Under 35 U.S.C. § 101
50. GenomeDx denies that any asserted claim of the '893 Patent is invalid under 35 U.S.C. § 101. GenomeDx incorporates by reference each and every admission, denial, and averment set forth in its responses to Counts I through IV above, including its responses to Count IV, as though fully restated herein.
51. GenomeDx avers that the asserted claims of the '893 Patent recite specific technical limitations that, individually and as an ordered combination, render the claims patent-eligible. These limitations include, without limitation: (a) normalization of gene-expression data from FFPE prostate tissue using a defined reference gene panel; (b) input of the normalized expression data into a random-forest classifier that has been trained on a cohort of at least 500 patient samples with known clinical outcomes; and (c) output of a numerical prognostic score on a continuous scale correlated with the risk of metastasis within five years. These steps constitute a patent-eligible improvement in the diagnostic arts. They are not directed merely to an abstract idea or natural phenomenon, but rather to a specific and practical method of processing biological data through defined computational and laboratory techniques to produce a clinically useful diagnostic output.
52. GenomeDx denies that the inclusion of machine-learning classification methodology renders the claims of the '893 Patent abstract. The machine-learning classifier recited in the claims is not an end in itself but is integrated into a specific diagnostic method that transforms raw biological data into actionable clinical information through a series of defined technical steps.
Response to Count VI: Declaratory Judgment of Invalidity of the '647 Patent Under 35 U.S.C. § 101
53. GenomeDx denies that any asserted claim of the '647 Patent is invalid under 35 U.S.C. § 101. GenomeDx incorporates by reference each and every admission, denial, and averment set forth in its responses to Counts I through V above, as though fully restated herein.
54. GenomeDx avers that the asserted claims of the '647 Patent recite an integrated method that combines genomic data with clinical data to generate a composite risk metric for post-prostatectomy cancer prognosis. This integration of genomic and clinical variables represents a specific, practical application of any underlying natural relationship between gene expression and clinical outcomes. The claims do not merely observe a natural correlation; they prescribe a defined method of combining particular types of data through a trained computational model to generate a composite output that goes beyond what any individual data type or any individual clinical variable could provide. The claims thus recite patent-eligible subject matter under § 101.
55. GenomeDx notes that this Court, in its Order dated January 13, 2026, denied Helios's Motion to Dismiss GenomeDx's infringement claims (Counts II and III of GenomeDx's Complaint) on § 101 grounds, finding that Helios's patent-eligibility challenges were premature in the absence of full claim construction. That ruling is relevant to the question of whether Helios's § 101 invalidity counterclaims can be adjudicated at this stage and supports GenomeDx's position that the § 101 issues require full development of the factual record through claim construction and discovery.
Response to Count VII: Declaratory Judgment of Invalidity of the '271 Patent Under 35 U.S.C. § 102
56. GenomeDx denies that any asserted claim of the '271 Patent is anticipated by any prior art reference under 35 U.S.C. § 102, including Nakamura et al. (U.S. Patent No. 9,617,340) or any other reference identified or relied upon by Helios. GenomeDx incorporates by reference each and every admission, denial, and averment set forth above as though fully restated herein.
57. GenomeDx avers that Nakamura et al. does not disclose each and every element of any asserted claim of the '271 Patent, arranged as claimed. Without conceding the relevance or materiality of Nakamura to the asserted claims, GenomeDx states that Nakamura discloses a different gene panel, a different classification methodology, and a different clinical application than those recited in the '271 Patent claims. The '271 Patent claims are entitled to a presumption of validity under 35 U.S.C. § 282, which presumption Helios must overcome by clear and convincing evidence. See Kestrel Partners LLC v. i4i Ltd. P'ship, 564 U.S. 91 (2011).
58. GenomeDx denies that any other prior art reference not yet identified by Helios anticipates the asserted claims of the '271 Patent, and reserves the right to respond to any additional prior art references identified by Helios during the course of discovery and in accordance with any scheduling orders entered by the Court.
Response to Count VIII: Declaratory Judgment of Invalidity Under 35 U.S.C. § 103
59. GenomeDx denies that any asserted claim of any patent-in-suit is obvious under 35 U.S.C. § 103 in view of any combination of prior art references, whether taken individually or in combination. GenomeDx incorporates by reference each and every admission, denial, and averment set forth above as though fully restated herein.
60. GenomeDx specifically denies that the asserted claims of any patent-in-suit would have been obvious in view of Nakamura et al. (U.S. Patent No. 9,617,340), Gagnon (WO 2018/065413), Thornberry et al. ("Ensemble Machine Learning Methods for Predicting Cancer Recurrence," Journal of Computational Oncology, Vol. 14, No. 3, pp. 287–301, March 2015), and Klein et al. ("A Genomic Classifier Improves Prediction of Metastatic Disease Within 5 Years After Surgery in Node-Negative High-Risk Prostate Cancer," European Urology, Vol. 66, No. 1, pp. 45–52, 2014), whether considered individually or in any combination.
61. GenomeDx avers that the prior art identified by Helios does not teach or suggest the specific combinations of features recited in the asserted claims of the patents-in-suit. A person of ordinary skill in the art at the time of the inventions would not have been motivated to combine these references in the manner alleged by Helios to arrive at the claimed inventions, and even if motivated to combine such references, would not have had a reasonable expectation of success in achieving the specific technical results claimed. Helios's obviousness theory rests on impermissible hindsight reconstruction of the claimed inventions.
62. GenomeDx further avers that objective indicia of non-obviousness—so-called "secondary considerations"—strongly support the validity of the asserted claims. These secondary considerations include, without limitation:
(a) Commercial success: The Decipher® Prostate genomic classifier test, which practices the claimed inventions, has achieved extraordinary commercial success. In fiscal year 2024, GenomeDx generated revenue of $387.6 million from the Decipher® test, representing a compound annual growth rate exceeding 30% since the test's commercial launch. The Decipher® test is the market-leading post-prostatectomy genomic classifier in the United States and is used by thousands of urologists and oncologists to guide treatment decisions for prostate cancer patients.
(b) Industry acclaim: The Decipher® test and the underlying inventions claimed in the patents-in-suit have received widespread recognition in the medical and scientific communities, including endorsement in clinical practice guidelines issued by the National Comprehensive Cancer Network ("NCCN"), the American Urological Association ("AUA"), and the American Society of Clinical Oncology ("ASCO").
(c) Copying by competitors: Helios's ProstaSignal™ Genomic Classifier is a close copy of the methods claimed in the patents-in-suit, employing a substantially similar multi-gene expression panel, machine-learning classification approach, and integrated genomic-clinical risk stratification methodology. Helios's decision to develop a product that practices the patented methods, rather than designing around the patents, is probative evidence of non-obviousness.
(d) Long-felt but unmet need: Prior to the inventions claimed in the patents-in-suit, there existed a long-felt but unmet need in the field of prostate cancer treatment for reliable post-prostatectomy prognostic tools that could predict the risk of metastasis with sufficient accuracy to guide adjuvant therapy decisions. The claimed inventions addressed that unmet need by providing a validated, reproducible, and clinically actionable genomic classification method.
63. GenomeDx further avers that, during prosecution of the '647 Patent, Dr. Rajan Mehta submitted a declaration under 37 C.F.R. § 1.132 establishing that the combined genomic-clinical model claimed in the '647 Patent achieved unexpected and superior results compared to genomic-only models and clinical-variable-only models, including statistically significant improvements in the area under the receiver operating characteristic curve ("AUC") for five-year metastasis prediction. This declaration was credited by the USPTO Examiner in withdrawing the § 103 rejections and allowing the claims. The unexpected results demonstrated by Dr. Mehta's declaration constitute additional evidence of non-obviousness.
Response to Count IX: Declaratory Judgment of Unenforceability
64. GenomeDx denies that any patent-in-suit is unenforceable for any reason, including, without limitation, inequitable conduct, unclean hands, or patent misuse. GenomeDx incorporates by reference each and every admission, denial, and averment set forth above as though fully restated herein.
65. GenomeDx denies that it, any named inventor of any patent-in-suit, or any person involved in the prosecution of any patent-in-suit engaged in any fraud, misrepresentation, material omission, or other misconduct before the USPTO during the prosecution of any application that issued as a patent-in-suit. All individuals involved in the prosecution of the patents-in-suit acted in good faith and in compliance with their duties of candor and good faith under 37 C.F.R. § 1.56.
66. GenomeDx avers that all material prior art known to the applicants and their representatives was disclosed to the USPTO during prosecution, as reflected in the Information Disclosure Statements ("IDS") filed in each application. The prosecution histories of the patents-in-suit demonstrate full and complete compliance with the duty of disclosure.
67. GenomeDx denies any allegation that it has engaged in unclean hands, patent misuse, or any other conduct that would render any patent-in-suit unenforceable. GenomeDx has not attempted to extend the scope of its patent rights beyond the claims as issued, has not tied its patent licenses to unpatented products or services, and has not otherwise engaged in any anticompetitive conduct in connection with the patents-in-suit.
AFFIRMATIVE DEFENSES TO COUNTERCLAIMS
GenomeDx asserts the following affirmative defenses to Helios's Counterclaims without assuming the burden of proof on any issue for which the burden properly rests with Helios.
First Affirmative Defense: Failure to State a Claim
Helios's Counterclaims, and each of them, fail to state a claim upon which relief can be granted under Federal Rule of Civil Procedure 12(b)(6). Helios has not alleged facts sufficient to establish that it is entitled to any of the declaratory relief it seeks, and its legal theories are insufficient as a matter of law to support the relief requested.
Second Affirmative Defense: Presumption of Validity
Each of the patents-in-suit—U.S. Patent Nos. 10,438,271, 11,204,893, and 11,891,647—was duly and lawfully issued by the United States Patent and Trademark Office after thorough examination, including consideration of prior art and patent-eligibility requirements. Under 35 U.S.C. § 282, each patent-in-suit is entitled to a presumption of validity, and Helios bears the burden of proving invalidity by clear and convincing evidence. See Kestrel Partners LLC v. i4i Ltd. P'ship, 564 U.S. 91, 95 (2011). Helios cannot meet this burden.
Third Affirmative Defense: Prosecution History Supports Validity
The prosecution histories of the '271, '893, and '647 Patents demonstrate that the USPTO considered and rejected the same or substantially similar invalidity arguments now raised by Helios in its Counterclaims. Specifically, the USPTO considered and overcame § 101 subject-matter eligibility challenges during prosecution of the '271 Patent, § 102 anticipation arguments based on Nakamura et al. during prosecution of the '893 Patent, and § 103 obviousness arguments based on combinations of Nakamura et al. and Gagnon during prosecution of the '647 Patent. Helios's recycled invalidity theories, which are largely identical to the arguments already considered and rejected by the USPTO, are entitled to diminished weight and do not overcome the presumption of validity.
Fourth Affirmative Defense: Patent Eligibility Under § 101
The asserted claims of all three patents-in-suit are directed to patent-eligible subject matter under 35 U.S.C. § 101. The claims recite specific, concrete diagnostic methods with particular technical steps—including RNA extraction, gene-expression measurement, data normalization, machine-learning classification, and risk stratification—that constitute improvements in the art of genomic cancer prognosis. The claims are not directed to abstract ideas, laws of nature, or natural phenomena, and they satisfy both steps of the patent-eligibility framework set forth in Alice Corp. Pty. Ltd. v. CLS Bank International, 573 U.S. 208 (2014), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).
Fifth Affirmative Defense: No Anticipation
No single prior art reference, including Nakamura et al. (U.S. Patent No. 9,617,340) or any other reference identified or relied upon by Helios, discloses each and every limitation of any asserted claim of any patent-in-suit, arranged as claimed. The asserted claims are therefore not anticipated under 35 U.S.C. § 102.
Sixth Affirmative Defense: Non-Obviousness
The claimed inventions of the patents-in-suit are non-obvious in view of the prior art under 35 U.S.C. § 103. The specific combination of features recited in the asserted claims is not taught or suggested by any prior art reference or combination of references identified by Helios. Moreover, objective indicia of non-obviousness strongly support the validity of the asserted claims, including: (a) the extraordinary commercial success of the Decipher® Prostate genomic classifier test, which generated revenue of $387.6 million in fiscal year 2024; (b) widespread industry recognition and endorsement of the Decipher® test in major clinical practice guidelines; (c) copying of the claimed methods by Helios and other competitors; (d) the long-felt but unmet need for reliable post-prostatectomy prognostic tools; and (e) unexpected results demonstrated by the combined genomic-clinical model of the '647 Patent. The prior art does not provide any teaching, suggestion, or motivation to combine references in the manner alleged by Helios, and Helios's obviousness arguments rest on impermissible hindsight analysis.
Seventh Affirmative Defense: Enforceability
The patents-in-suit are enforceable. There has been no inequitable conduct, fraud, misrepresentation, or material omission before the USPTO in connection with the prosecution of any patent-in-suit. All material information known to the applicants and their counsel was disclosed to the USPTO in compliance with the duty of candor under 37 C.F.R. § 1.56. Helios's unenforceability counterclaim is without merit and fails to satisfy the heightened pleading standard applicable to inequitable conduct claims under Brightmoor & Co., Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc).
Eighth Affirmative Defense: Infringement
Helios's ProstaSignal™ Genomic Classifier infringes the asserted claims of all three patents-in-suit, either literally or under the doctrine of equivalents, as set forth in GenomeDx's Complaint (Dkt. No. 1). Helios's counterclaims for declaratory judgment of non-infringement of the '271, '893, and '647 Patents are without merit and should be denied. The evidence will demonstrate that ProstaSignal™ practices each and every limitation of the asserted claims, and Helios's non-infringement arguments are based on distinctions without a difference.
Ninth Affirmative Defense: Waiver, Estoppel, and Laches
To the extent applicable, Helios's counterclaims may be barred, in whole or in part, by the doctrines of waiver, estoppel, and/or laches. GenomeDx reserves the right to develop the factual basis for these defenses through discovery.
Tenth Affirmative Defense: Reservation of Defenses
GenomeDx reserves the right to assert additional affirmative defenses as discovery progresses and additional facts are developed. Discovery in this action is ongoing, and GenomeDx has not yet had the opportunity to review all relevant documents and information in Helios's possession, custody, or control. GenomeDx expressly reserves the right to amend this Answer to assert additional affirmative defenses as may be warranted by the facts and circumstances revealed through discovery, consistent with Federal Rule of Civil Procedure 15 and any applicable scheduling orders.
PRAYER FOR RELIEF
WHEREFORE, Plaintiff and Counterclaim Defendant Genome Dx Therapeutics Inc. respectfully requests that this Court enter judgment as follows:
1. Denying and dismissing each and every one of Helios's Counterclaims in their entirety, with prejudice, and awarding Helios no relief thereon;
2. Declaring that Helios has infringed, and continues to infringe, the asserted claims of U.S. Patent Nos. 10,438,271, 11,204,893, and 11,891,647 through its manufacture, use, sale, offer for sale, and importation of the ProstaSignal™ Genomic Classifier and related products and services;
3. Declaring that all asserted claims of U.S. Patent Nos. 10,438,271, 11,204,893, and 11,891,647 are valid and enforceable;
4. Awarding GenomeDx damages adequate to compensate for Helios's past and ongoing infringement of the patents-in-suit, including lost profits and/or a reasonable royalty, in an amount to be determined at trial, together with prejudgment and post-judgment interest at the maximum rate allowed by law;
5. Awarding GenomeDx enhanced damages up to three times the amount of compensatory damages pursuant to 35 U.S.C. § 284, in the event Helios's infringement is found to be willful;
6. Issuing a permanent injunction pursuant to 35 U.S.C. § 283 restraining and enjoining Helios, its officers, agents, servants, employees, attorneys, affiliates, subsidiaries, and all persons acting in concert or participation with Helios, from further infringement of the patents-in-suit;
7. Awarding GenomeDx its reasonable attorneys' fees and costs incurred in this action pursuant to 35 U.S.C. § 285, in the event the Court finds this to be an exceptional case;
8. Awarding GenomeDx its costs of suit herein; and
9. Awarding GenomeDx such other and further relief as this Court deems just and proper.
JURY DEMAND
Plaintiff and Counterclaim Defendant Genome Dx Therapeutics Inc. hereby demands a trial by jury on all issues so triable in this action, including all claims and counterclaims, pursuant to Federal Rule of Civil Procedure 38.
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
CALDERWOOD & HARKNESS LLP
By: ________
Catherine Bloom (CA Bar No. 247831)
Alan Ngo (CA Bar No. 289654) Peter Vassiliev (CA Bar No. 302417) Wendy Schultz (CA Bar No. 314209)
555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 773-6200 Facsimile: (415) 773-6201
Email: cbloom@calderwoodharkness.com
Attorneys for Plaintiff and Counterclaim Defendant Genome Dx Therapeutics Inc.
Dated: May 30, 2025
CERTIFICATE OF SERVICE
I, Catherine Bloom, hereby certify that on May 30, 2025, I caused a true and correct copy of the foregoing PLAINTIFF AND COUNTERCLAIM DEFENDANT GENOME DX THERAPEUTICS INC.'S ANSWER TO DEFENDANT AND COUNTERCLAIM PLAINTIFF HELIOS PRECISION DIAGNOSTICS, INC.'S COUNTERCLAIMS to be served on all counsel of record via the Court's CM/ECF electronic filing system, which will send notification of such filing to the following:
Marcus Pellegrini Danielle Forrest Owen Chu RIDGECREST DURNEVAL LLP One Federal Street, Suite 3400 Boston, Massachusetts 02110
and
350 South Grand Avenue, Suite 2800 Los Angeles, California 90071
Attorneys for Defendant and Counterclaim Plaintiff Helios Precision Diagnostics, Inc.
By: ________
Catherine Bloom
GENOME DX THERAPEUTICS INC., | Case No. 3:25-cv-01847-JWL
Plaintiff and Counterclaim Defendant, | Hon. Jessica W. Langston
v. | PLAINTIFF AND COUNTERCLAIM DEFENDANT GENOME DX THERAPEUTICS INC.'S ANSWER TO DEFENDANT AND COUNTERCLAIM PLAINTIFF HELIOS PRECISION DIAGNOSTICS, INC.'S COUNTERCLAIMS
HELIOS PRECISION DIAGNOSTICS, INC.,
Defendant and Counterclaim Plaintiff. | Jury Trial Demanded

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA

GENERAL DENIAL

RESPONSES TO COUNTERCLAIM ALLEGATIONS

RESPONSES TO COUNTERCLAIM COUNTS

AFFIRMATIVE DEFENSES TO COUNTERCLAIMS

PRAYER FOR RELIEF

JURY DEMAND

CALDERWOOD & HARKNESS LLP

CALDERWOOD & HARKNESS LLP

CERTIFICATE OF SERVICE

HELIOS PRECISION DIAGNOSTICS, INC.,

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