[sheet: Cover]

Field	Value
Document Title	Claim Chart — U.S. Patent No. 11,891,647 ('647 Patent) vs. Helios ProstaSignal™ Genomic Classifier
Matter	Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc.
Case No.	3:25-cv-01847-JWL (N.D. Cal.)
Court	U.S. District Court, Northern District of California
Assigned Judge	Hon. Jessica W. Langston
Magistrate Judge	Hon. David R. Cabrera
Patent-in-Suit	U.S. Patent No. 11,891,647
Patent Title	Improved Methods for Genomic Risk Stratification in Prostate Cancer Using Combined Biomarker and Clinical Variable Models
Filing Date	September 9, 2021
Issue Date	February 6, 2024
Expiration Date	September 9, 2041
Named Inventors	Dr. Rajan Mehta, Dr. Kevin Ostrowski, Dr. Priya Shah
Asserted Claims	Claims 1, 4, 6, 11, and 15
Accused Product	ProstaSignal™ Genomic Classifier (Helios Precision Diagnostics, Inc.)
Product Launch Date	October 7, 2024
Helios CLIA Laboratory	9830 Mesa Rim Road, Suite 140, San Diego, CA 92121
Helios MAAA Code	0239M
Prepared By	Peter Vassiliev, Lead Associate, Calderwood & Harkness LLP
Reviewed By	Catherine Bloom, Responsible Partner, Calderwood & Harkness LLP
Date Prepared	March 2025 (updated February 2026)
Confidentiality	ATTORNEY WORK PRODUCT — PRIVILEGED AND CONFIDENTIAL
Client	Genome Dx Therapeutics Inc.
Client Address	4750 Torrey Pines Road, Suite 300, San Diego, CA 92130
Outside Counsel	Calderwood & Harkness LLP, 555 Mission Street, Suite 3100, San Francisco, CA 94105

Relationship to Patent Family

[sheet: Claim 1]

Element ID	Claim Element / Limitation	ProstaSignal™ Corresponding Feature	Evidence / Source	Infringement Theory	Notes
1[preamble]	A method for generating an integrated prognostic report comprising:	ProstaSignal™ is a genomic classifier test that generates an integrated prognostic report combining genomic and clinical data for prostate cancer patients post-radical prostatectomy. The output report includes a 'ProstaScore' (0–100) along with clinical variables and a composite risk classification (Low / Intermediate / High).	ProstaSignal™ product literature; Helios website (accessed Feb. 2026); sample ProstaSignal™ patient report (HPD-PROD-000412); Helios 510(k)/LDT documentation submitted to CLIA (HPD-REG-001087)	Literal	ProstaSignal™ generates an integrated report combining genomic score with clinical covariates, directly meeting the preamble's 'integrated prognostic report' requirement.
1(a)	performing RNA extraction and expression profiling on a prostate tumor specimen;	ProstaSignal™ performs RNA extraction from formalin-fixed paraffin-embedded (FFPE) prostate tumor tissue specimens obtained post-radical prostatectomy at Helios's CLIA-certified laboratory (9830 Mesa Rim Road, Suite 140, San Diego, CA 92121). Gene expression profiling is performed on the extracted RNA using a 24-gene expression panel.	ProstaSignal™ Technical Validation Study (HPD-VAL-000201); Helios laboratory SOPs (HPD-LAB-003344, HPD-LAB-003345); Dr. Elaine Kossack presentation to Corinth Ventures board (HPD-BD-000089)	Literal	ProstaSignal™ uses a 24-gene panel; GenomeDx's Decipher® uses 22 genes. 19 of the 24 ProstaSignal™ genes overlap with GenomeDx's patented predefined gene set. The claim requires expression profiling on a prostate tumor specimen — ProstaSignal™ performs exactly this step.
1(b)	computing a genomic risk score using a classifier comprising at least 20 gene features;	ProstaSignal™ computes a 'ProstaScore' (numerical score from 0 to 100) using a gradient-boosted decision tree classifier trained on expression data from a panel of 24 gene features, which exceeds the claim's minimum of 20 gene features.	ProstaSignal™ algorithm documentation (HPD-ALG-000156); Dr. Anton Rykov technical memorandum on ProstaScore computation (HPD-R&D-002718); Helios patent application (U.S. Appl. No. 18/234,567, published)	Literal	The 24-gene panel exceeds the 'at least 20 gene features' limitation. The ProstaScore is a 'genomic risk score' computed by a machine-learning classifier. The claim does not specify a particular classifier type (unlike the '893 Patent's random-forest requirement), so the gradient-boosted decision tree literally meets this element.
1(c)	combining the genomic risk score with at least two clinical covariates selected from Gleason score, PSA level, surgical margin status, and pathological stage;	ProstaSignal™ combines the ProstaScore with (1) Gleason grade group (a refinement of Gleason score) and (2) pre-operative PSA level to produce a composite assessment. These two clinical covariates are selected from the enumerated list in the claim: 'Gleason score' and 'PSA level.' Helios's patient report template and ordering interface require treating physicians to provide Gleason grade group and pre-operative PSA as inputs.	ProstaSignal™ sample patient report (HPD-PROD-000412, HPD-PROD-000413); Helios ordering portal screenshots (HPD-COMM-001290); Derek Mallinson commercial training deck (HPD-COMM-000847); Helios investor presentation Q4 2024 (HPD-BD-000112)	Literal	ProstaSignal™ explicitly combines ProstaScore with Gleason grade group and pre-operative PSA — two clinical covariates from the claim's enumerated list. Gleason grade group is a direct derivative of and functionally equivalent to 'Gleason score' as claimed. Note: some ProstaSignal™ reports also include surgical margin status as optional additional data, which would constitute a third covariate from the enumerated list.
1(d)	and generating a composite risk metric and transmitting it to a healthcare provider.	ProstaSignal™ generates a composite risk classification (Low, Intermediate, or High risk) that integrates the ProstaScore and clinical covariates. This composite risk metric is transmitted to the ordering healthcare provider via Helios's electronic reporting portal (HeliosConnect™), fax, and/or integration with electronic health record systems.	ProstaSignal™ sample reports (HPD-PROD-000412 through HPD-PROD-000420); HeliosConnect™ platform documentation (HPD-IT-000567); Helios CLIA laboratory reporting procedures (HPD-LAB-003401)	Literal	The composite risk classification (Low/Intermediate/High) combining genomic and clinical data constitutes a 'composite risk metric.' Transmission to healthcare providers via electronic portal, fax, and EHR integration satisfies 'transmitting it to a healthcare provider.'

[sheet: Claim 4]

Element ID	Claim Element / Limitation	ProstaSignal™ Corresponding Feature	Evidence / Source	Infringement Theory	Notes
4[dependency]	The method of claim 1, wherein the classifier is a machine-learning model selected from the group consisting of random forest, gradient boosting, support vector machine, and neural network classifiers.	ProstaSignal™ uses a gradient-boosted decision tree classifier, which falls within the Markush group recited in Claim 4 as 'gradient boosting.'	ProstaSignal™ algorithm documentation (HPD-ALG-000156); Dr. Anton Rykov technical memorandum (HPD-R&D-002718); Helios validation study publication (HPD-PUB-000034)	Literal	Unlike the '893 Patent (which specifically claims a 'random-forest classifier'), Claim 4 of the '647 Patent expressly lists 'gradient boosting' as one of the enumerated classifier types. ProstaSignal™'s gradient-boosted decision tree literally falls within this limitation. This claim provides the strongest literal infringement basis for the classifier element.
4[Claim 1 elements]	[All elements of Claim 1 incorporated by reference]	[See Claim 1 sheet for full mapping]	[See Claim 1 sheet]	Literal	Claim 4 depends from Claim 1; all Claim 1 limitations met as charted in the Claim 1 sheet.

[sheet: Claim 6]

Element ID	Claim Element / Limitation	ProstaSignal™ Corresponding Feature	Evidence / Source	Infringement Theory	Notes
6[dependency]	The method of claim 1, wherein the composite risk metric comprises a numerical score that combines the genomic risk score and the at least two clinical covariates using a weighted combination model.	ProstaSignal™ generates a composite numerical output that integrates the ProstaScore (genomic risk score) with Gleason grade group and pre-operative PSA using a weighted algorithm. The weighting scheme assigns coefficients to each input variable based on training data from Helios's validation cohort. The resulting composite numerical value is then mapped to the Low / Intermediate / High risk categories.	ProstaSignal™ algorithm architecture documentation (HPD-ALG-000156, HPD-ALG-000161); Helios technical white paper (HPD-PUB-000034); Dr. Elaine Kossack internal memorandum on composite scoring methodology (HPD-R&D-002801)	Literal	The weighted combination of ProstaScore with clinical covariates to produce a composite numerical output constitutes a 'weighted combination model' as claimed. Discovery is ongoing to obtain precise weighting coefficients (subject to Protective Order, Highly Confidential — Attorneys' Eyes Only designation).
6[Claim 1 elements]	[All elements of Claim 1 incorporated by reference]	[See Claim 1 sheet for full mapping]	[See Claim 1 sheet]	Literal	Claim 6 depends from Claim 1; all Claim 1 limitations met as charted in the Claim 1 sheet.

[sheet: Claim 11]

Element ID	Claim Element / Limitation	ProstaSignal™ Corresponding Feature	Evidence / Source	Infringement Theory	Notes
11[preamble]	A system for genomic risk stratification in prostate cancer comprising:	Helios operates the ProstaSignal™ Genomic Classifier as a system for genomic risk stratification in prostate cancer, encompassing laboratory instrumentation, computational infrastructure, and reporting modules at its CLIA-certified laboratory in San Diego, CA.	Helios CLIA certification documents; laboratory equipment inventory (HPD-LAB-003100); Helios IT infrastructure documentation (HPD-IT-000540)	Literal	ProstaSignal™ is operated as an integrated system for prostate cancer genomic risk stratification.
11(a)	a sample processing module configured to perform RNA extraction and gene expression measurement on a prostate tumor specimen for a panel of at least 20 gene features;	Helios's San Diego CLIA laboratory includes automated RNA extraction equipment and gene expression measurement instrumentation (e.g., quantitative RT-PCR or microarray platform) configured to process FFPE prostate tumor specimens and measure expression of 24 genes.	Helios laboratory SOPs (HPD-LAB-003344, HPD-LAB-003345); equipment purchase orders (HPD-FIN-004201); validation protocols (HPD-VAL-000201)	Literal	24-gene panel exceeds the 'at least 20 gene features' requirement.
11(b)	a computational module configured to: (i) compute a genomic risk score from the gene expression measurement using a trained machine-learning classifier; (ii) receive at least two clinical covariates selected from Gleason score, PSA level, surgical margin status, and pathological stage; and (iii) generate a composite risk metric by combining the genomic risk score with the at least two clinical covariates;	Helios's bioinformatics pipeline (executed on cloud computing infrastructure and/or local servers) includes: (i) a gradient-boosted decision tree classifier that computes the ProstaScore from 24-gene expression data; (ii) an input module that receives Gleason grade group and pre-operative PSA from the ordering physician via the HeliosConnect™ portal; and (iii) a composite scoring algorithm that combines ProstaScore with Gleason grade group and PSA to generate a composite risk classification (Low / Intermediate / High).	ProstaSignal™ system architecture documents (HPD-IT-000567, HPD-ALG-000156); Dr. Anton Rykov system design specifications (HPD-R&D-002718); HeliosConnect™ portal user guide (HPD-COMM-001290)	Literal	Each sub-element (i), (ii), and (iii) of the computational module limitation is met by ProstaSignal™'s bioinformatics pipeline and data input/output architecture.
11(c)	and a reporting module configured to transmit the composite risk metric to a healthcare provider.	Helios transmits ProstaSignal™ results (including composite risk classification) to ordering healthcare providers through the HeliosConnect™ electronic portal, fax transmission, and/or EHR integration (e.g., HL7 interface).	HeliosConnect™ platform documentation (HPD-IT-000567); sample transmitted reports (HPD-PROD-000412 through HPD-PROD-000420); Helios CLIA reporting procedures (HPD-LAB-003401)	Literal	Transmission of composite risk metric via electronic portal, fax, and EHR integration satisfies the reporting module limitation.

[sheet: Claim 15]

Element ID	Claim Element / Limitation	ProstaSignal™ Corresponding Feature	Evidence / Source	Infringement Theory	Notes
15[dependency]	The system of claim 11, wherein the composite risk metric classifies the patient into one of at least three risk categories correlated with likelihood of metastasis within a defined time period.	ProstaSignal™ classifies patients into three risk categories: Low, Intermediate, and High risk. These categories are correlated with the likelihood of metastasis within 5 years following radical prostatectomy, as demonstrated in Helios's clinical validation cohort studies.	ProstaSignal™ clinical validation publication (HPD-PUB-000034); Helios regulatory submission to MolDX for MAAA code 0239M (HPD-REG-001100); ProstaSignal™ sample reports showing Low / Intermediate / High classification (HPD-PROD-000412 through HPD-PROD-000420)	Literal	Three risk categories (Low / Intermediate / High) meet the 'at least three risk categories' requirement. Correlation with 5-year metastasis probability meets the 'correlated with likelihood of metastasis within a defined time period' limitation.
15[Claim 11 elements]	[All elements of Claim 11 incorporated by reference]	[See Claim 11 sheet for full mapping]	[See Claim 11 sheet]	Literal	Claim 15 depends from Claim 11; all Claim 11 limitations met as charted in the Claim 11 sheet.

[sheet: Cover]
Field | Value
Document Title | Claim Chart — U.S. Patent No. 11,891,647 ('647 Patent) vs. Helios ProstaSignal™ Genomic Classifier
Matter | Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc.
Case No. | 3:25-cv-01847-JWL (N.D. Cal.)
Court | U.S. District Court, Northern District of California
Assigned Judge | Hon. Jessica W. Langston
Magistrate Judge | Hon. David R. Cabrera
Patent-in-Suit | U.S. Patent No. 11,891,647
Patent Title | Improved Methods for Genomic Risk Stratification in Prostate Cancer Using Combined Biomarker and Clinical Variable Models
Filing Date | September 9, 2021
Issue Date | February 6, 2024
Expiration Date | September 9, 2041
Named Inventors | Dr. Rajan Mehta, Dr. Kevin Ostrowski, Dr. Priya Shah
Asserted Claims | Claims 1, 4, 6, 11, and 15
Accused Product | ProstaSignal™ Genomic Classifier (Helios Precision Diagnostics, Inc.)
Product Launch Date | October 7, 2024
Helios CLIA Laboratory | 9830 Mesa Rim Road, Suite 140, San Diego, CA 92121
Helios MAAA Code | 0239M
Prepared By | Peter Vassiliev, Lead Associate, Calderwood & Harkness LLP
Reviewed By | Catherine Bloom, Responsible Partner, Calderwood & Harkness LLP
Date Prepared | March 2025 (updated February 2026)
Confidentiality | ATTORNEY WORK PRODUCT — PRIVILEGED AND CONFIDENTIAL
Client | Genome Dx Therapeutics Inc.
Client Address | 4750 Torrey Pines Road, Suite 300, San Diego, CA 92130
Outside Counsel | Calderwood & Harkness LLP, 555 Mission Street, Suite 3100, San Francisco, CA 94105
Relationship to Patent Family | Terminal disclaimer filed over '271 Patent (U.S. 10,438,271) and '893 Patent (U.S. 11,204,893); shares priority chain with '271 Patent (June 14, 2016 effective filing date for certain claims) but independent filing date of September 9, 2021
[sheet: Claim 1]
Element ID | Claim Element / Limitation | ProstaSignal™ Corresponding Feature | Evidence / Source | Infringement Theory | Notes
1[preamble] | A method for generating an integrated prognostic report comprising: | ProstaSignal™ is a genomic classifier test that generates an integrated prognostic report combining genomic and clinical data for prostate cancer patients post-radical prostatectomy. The output report includes a 'ProstaScore' (0–100) along with clinical variables and a composite risk classification (Low / Intermediate / High). | ProstaSignal™ product literature; Helios website (accessed Feb. 2026); sample ProstaSignal™ patient report (HPD-PROD-000412); Helios 510(k)/LDT documentation submitted to CLIA (HPD-REG-001087) | Literal | ProstaSignal™ generates an integrated report combining genomic score with clinical covariates, directly meeting the preamble's 'integrated prognostic report' requirement.
1(a) | performing RNA extraction and expression profiling on a prostate tumor specimen; | ProstaSignal™ performs RNA extraction from formalin-fixed paraffin-embedded (FFPE) prostate tumor tissue specimens obtained post-radical prostatectomy at Helios's CLIA-certified laboratory (9830 Mesa Rim Road, Suite 140, San Diego, CA 92121). Gene expression profiling is performed on the extracted RNA using a 24-gene expression panel. | ProstaSignal™ Technical Validation Study (HPD-VAL-000201); Helios laboratory SOPs (HPD-LAB-003344, HPD-LAB-003345); Dr. Elaine Kossack presentation to Corinth Ventures board (HPD-BD-000089) | Literal | ProstaSignal™ uses a 24-gene panel; GenomeDx's Decipher® uses 22 genes. 19 of the 24 ProstaSignal™ genes overlap with GenomeDx's patented predefined gene set. The claim requires expression profiling on a prostate tumor specimen — ProstaSignal™ performs exactly this step.
1(b) | computing a genomic risk score using a classifier comprising at least 20 gene features; | ProstaSignal™ computes a 'ProstaScore' (numerical score from 0 to 100) using a gradient-boosted decision tree classifier trained on expression data from a panel of 24 gene features, which exceeds the claim's minimum of 20 gene features. | ProstaSignal™ algorithm documentation (HPD-ALG-000156); Dr. Anton Rykov technical memorandum on ProstaScore computation (HPD-R&D-002718); Helios patent application (U.S. Appl. No. 18/234,567, published) | Literal | The 24-gene panel exceeds the 'at least 20 gene features' limitation. The ProstaScore is a 'genomic risk score' computed by a machine-learning classifier. The claim does not specify a particular classifier type (unlike the '893 Patent's random-forest requirement), so the gradient-boosted decision tree literally meets this element.
1(c) | combining the genomic risk score with at least two clinical covariates selected from Gleason score, PSA level, surgical margin status, and pathological stage; | ProstaSignal™ combines the ProstaScore with (1) Gleason grade group (a refinement of Gleason score) and (2) pre-operative PSA level to produce a composite assessment. These two clinical covariates are selected from the enumerated list in the claim: 'Gleason score' and 'PSA level.' Helios's patient report template and ordering interface require treating physicians to provide Gleason grade group and pre-operative PSA as inputs. | ProstaSignal™ sample patient report (HPD-PROD-000412, HPD-PROD-000413); Helios ordering portal screenshots (HPD-COMM-001290); Derek Mallinson commercial training deck (HPD-COMM-000847); Helios investor presentation Q4 2024 (HPD-BD-000112) | Literal | ProstaSignal™ explicitly combines ProstaScore with Gleason grade group and pre-operative PSA — two clinical covariates from the claim's enumerated list. Gleason grade group is a direct derivative of and functionally equivalent to 'Gleason score' as claimed. Note: some ProstaSignal™ reports also include surgical margin status as optional additional data, which would constitute a third covariate from the enumerated list.
1(d) | and generating a composite risk metric and transmitting it to a healthcare provider. | ProstaSignal™ generates a composite risk classification (Low, Intermediate, or High risk) that integrates the ProstaScore and clinical covariates. This composite risk metric is transmitted to the ordering healthcare provider via Helios's electronic reporting portal (HeliosConnect™), fax, and/or integration with electronic health record systems. | ProstaSignal™ sample reports (HPD-PROD-000412 through HPD-PROD-000420); HeliosConnect™ platform documentation (HPD-IT-000567); Helios CLIA laboratory reporting procedures (HPD-LAB-003401) | Literal | The composite risk classification (Low/Intermediate/High) combining genomic and clinical data constitutes a 'composite risk metric.' Transmission to healthcare providers via electronic portal, fax, and EHR integration satisfies 'transmitting it to a healthcare provider.'
[sheet: Claim 4]
Element ID | Claim Element / Limitation | ProstaSignal™ Corresponding Feature | Evidence / Source | Infringement Theory | Notes
4[dependency] | The method of claim 1, wherein the classifier is a machine-learning model selected from the group consisting of random forest, gradient boosting, support vector machine, and neural network classifiers. | ProstaSignal™ uses a gradient-boosted decision tree classifier, which falls within the Markush group recited in Claim 4 as 'gradient boosting.' | ProstaSignal™ algorithm documentation (HPD-ALG-000156); Dr. Anton Rykov technical memorandum (HPD-R&D-002718); Helios validation study publication (HPD-PUB-000034) | Literal | Unlike the '893 Patent (which specifically claims a 'random-forest classifier'), Claim 4 of the '647 Patent expressly lists 'gradient boosting' as one of the enumerated classifier types. ProstaSignal™'s gradient-boosted decision tree literally falls within this limitation. This claim provides the strongest literal infringement basis for the classifier element.
4[Claim 1 elements] | [All elements of Claim 1 incorporated by reference] | [See Claim 1 sheet for full mapping] | [See Claim 1 sheet] | Literal | Claim 4 depends from Claim 1; all Claim 1 limitations met as charted in the Claim 1 sheet.
[sheet: Claim 6]
Element ID | Claim Element / Limitation | ProstaSignal™ Corresponding Feature | Evidence / Source | Infringement Theory | Notes
6[dependency] | The method of claim 1, wherein the composite risk metric comprises a numerical score that combines the genomic risk score and the at least two clinical covariates using a weighted combination model. | ProstaSignal™ generates a composite numerical output that integrates the ProstaScore (genomic risk score) with Gleason grade group and pre-operative PSA using a weighted algorithm. The weighting scheme assigns coefficients to each input variable based on training data from Helios's validation cohort. The resulting composite numerical value is then mapped to the Low / Intermediate / High risk categories. | ProstaSignal™ algorithm architecture documentation (HPD-ALG-000156, HPD-ALG-000161); Helios technical white paper (HPD-PUB-000034); Dr. Elaine Kossack internal memorandum on composite scoring methodology (HPD-R&D-002801) | Literal | The weighted combination of ProstaScore with clinical covariates to produce a composite numerical output constitutes a 'weighted combination model' as claimed. Discovery is ongoing to obtain precise weighting coefficients (subject to Protective Order, Highly Confidential — Attorneys' Eyes Only designation).
6[Claim 1 elements] | [All elements of Claim 1 incorporated by reference] | [See Claim 1 sheet for full mapping] | [See Claim 1 sheet] | Literal | Claim 6 depends from Claim 1; all Claim 1 limitations met as charted in the Claim 1 sheet.
[sheet: Claim 11]
Element ID | Claim Element / Limitation | ProstaSignal™ Corresponding Feature | Evidence / Source | Infringement Theory | Notes
11[preamble] | A system for genomic risk stratification in prostate cancer comprising: | Helios operates the ProstaSignal™ Genomic Classifier as a system for genomic risk stratification in prostate cancer, encompassing laboratory instrumentation, computational infrastructure, and reporting modules at its CLIA-certified laboratory in San Diego, CA. | Helios CLIA certification documents; laboratory equipment inventory (HPD-LAB-003100); Helios IT infrastructure documentation (HPD-IT-000540) | Literal | ProstaSignal™ is operated as an integrated system for prostate cancer genomic risk stratification.
11(a) | a sample processing module configured to perform RNA extraction and gene expression measurement on a prostate tumor specimen for a panel of at least 20 gene features; | Helios's San Diego CLIA laboratory includes automated RNA extraction equipment and gene expression measurement instrumentation (e.g., quantitative RT-PCR or microarray platform) configured to process FFPE prostate tumor specimens and measure expression of 24 genes. | Helios laboratory SOPs (HPD-LAB-003344, HPD-LAB-003345); equipment purchase orders (HPD-FIN-004201); validation protocols (HPD-VAL-000201) | Literal | 24-gene panel exceeds the 'at least 20 gene features' requirement.
11(b) | a computational module configured to: (i) compute a genomic risk score from the gene expression measurement using a trained machine-learning classifier; (ii) receive at least two clinical covariates selected from Gleason score, PSA level, surgical margin status, and pathological stage; and (iii) generate a composite risk metric by combining the genomic risk score with the at least two clinical covariates; | Helios's bioinformatics pipeline (executed on cloud computing infrastructure and/or local servers) includes: (i) a gradient-boosted decision tree classifier that computes the ProstaScore from 24-gene expression data; (ii) an input module that receives Gleason grade group and pre-operative PSA from the ordering physician via the HeliosConnect™ portal; and (iii) a composite scoring algorithm that combines ProstaScore with Gleason grade group and PSA to generate a composite risk classification (Low / Intermediate / High). | ProstaSignal™ system architecture documents (HPD-IT-000567, HPD-ALG-000156); Dr. Anton Rykov system design specifications (HPD-R&D-002718); HeliosConnect™ portal user guide (HPD-COMM-001290) | Literal | Each sub-element (i), (ii), and (iii) of the computational module limitation is met by ProstaSignal™'s bioinformatics pipeline and data input/output architecture.
11(c) | and a reporting module configured to transmit the composite risk metric to a healthcare provider. | Helios transmits ProstaSignal™ results (including composite risk classification) to ordering healthcare providers through the HeliosConnect™ electronic portal, fax transmission, and/or EHR integration (e.g., HL7 interface). | HeliosConnect™ platform documentation (HPD-IT-000567); sample transmitted reports (HPD-PROD-000412 through HPD-PROD-000420); Helios CLIA reporting procedures (HPD-LAB-003401) | Literal | Transmission of composite risk metric via electronic portal, fax, and EHR integration satisfies the reporting module limitation.
[sheet: Claim 15]
Element ID | Claim Element / Limitation | ProstaSignal™ Corresponding Feature | Evidence / Source | Infringement Theory | Notes
15[dependency] | The system of claim 11, wherein the composite risk metric classifies the patient into one of at least three risk categories correlated with likelihood of metastasis within a defined time period. | ProstaSignal™ classifies patients into three risk categories: Low, Intermediate, and High risk. These categories are correlated with the likelihood of metastasis within 5 years following radical prostatectomy, as demonstrated in Helios's clinical validation cohort studies. | ProstaSignal™ clinical validation publication (HPD-PUB-000034); Helios regulatory submission to MolDX for MAAA code 0239M (HPD-REG-001100); ProstaSignal™ sample reports showing Low / Intermediate / High classification (HPD-PROD-000412 through HPD-PROD-000420) | Literal | Three risk categories (Low / Intermediate / High) meet the 'at least three risk categories' requirement. Correlation with 5-year metastasis probability meets the 'correlated with likelihood of metastasis within a defined time period' limitation.
15[Claim 11 elements] | [All elements of Claim 11 incorporated by reference] | [See Claim 11 sheet for full mapping] | [See Claim 11 sheet] | Literal | Claim 15 depends from Claim 11; all Claim 11 limitations met as charted in the Claim 11 sheet.

[sheet: Cover]

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