Contract analysis

[sheet: Cover] Field | Value Document Title | Claim Chart — U.S. Patent No. 11,204,893 ('893 Patent) vs. Helios ProstaSignal™ Genomic Classifier Matter | Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc. Case No. | 3:25-cv-01847-JWL Court | U.S. District Court, Northern District of California Assigned Judge | Hon. Jessica W. Langston Patent-in-Suit | U.S. Patent No. 11,204,893 Patent Title | Genomic C

Literal Infringement: GenomeDx contends that a gradient-boosted decision tree ensemble is a type of or functionally equivalent to a random-forest classifier, as both are ensemble methods based on decision trees. This position requires claim construction of 'random-forest classifier.' Helios will likely dispute literal infringement of this element.

Doctrine of Equivalents: The ProstaSignal™ GBDT classifier performs substantially the same function (combining multiple decision trees to generate a prediction), in substantially the same way (ensemble aggregation of decision-tree outputs trained on labeled patient data), to achieve substantially the same result (a numerical prognostic score predicting metastasis risk) as the claimed random-forest classifier. The dif

Note re Prosecution History Estoppel: During prosecution of the '893 Patent, the applicant distinguished Nakamura et al. (U.S. Patent No. 9,617,340) by arguing the specific random-forest classifier training methodology and minimum cohort size of 500 patients. The amendment narrowing to 'random-forest classifier' was made to distinguish Nakamura's neural-network approach, not to surrender all ensemble tree-based metho

Literal Infringement: Depends on construction of 'random-forest classifier' as discussed in Claim 1, Element 1[b]. If 'random-forest classifier' is construed broadly to encompass decision-tree ensemble methods, the 800-tree GBDT meets the 'at least 500 individual decision trees' limitation.

Doctrine of Equivalents: Even if 'random-forest classifier' is construed narrowly, the GBDT ensemble with ~800 trees performs the same function (aggregating predictions from a large number of decision trees), in the same way (iterative tree construction on training data), to achieve the same result (a robust prognostic score). The number of trees (800) exceeds the claimed minimum (500). | Helios algorithm architectur

However, further analysis is needed: GenomeDx's position is that the ProstaSignal™ panel, when including reference/normalization genes used in the normalization step (Element 1[a]), may include additional genes from the predefined set that bring the total to 22 or more. Helios's full gene list (including reference genes) must be confirmed from discovery documents.

Alternative: If literal infringement cannot be established (i.e., fewer than 22 genes from the predefined set), DOE analysis would consider whether the 5 non-overlapping genes perform substantially the same function in substantially the same way to achieve substantially the same result as the genes they replace. | ProstaSignal™ gene panel list (from Helios technical documentation, AEO); GenomeDx '893 Patent specifica

Same literal/DOE analysis as Claim 1, Element 1[b]: The 'random-forest classification algorithm' limitation is the central dispute. ProstaSignal™ uses gradient-boosted decision trees rather than random forests. DOE theory: function-way-result test is met; prosecution history estoppel analysis applies (see Claim 1 chart and Prosecution History Estoppel Analysis Memorandum). | Helios algorithm documentation (AEO); syst

All three sub-elements of this dependent claim are met by the ProstaSignal™ report format. | Sample ProstaSignal™ patient reports (multiple examples produced in discovery); Helios marketing materials showing sample report layout; ProstaSignal™ product brochure | Strong literal infringement. The ProstaSignal™ report format closely mirrors the claim language, including the graphical representation requirement.