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Biological Status Classification via Health Informatics

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Published April 2nd, 2026
Detected April 2nd, 2026
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Summary

The USPTO published patent application US20260092926A1 for a method of classifying biological status using health informatics. The method analyzes patient samples to quantify endogenous analytes and compares results to gender-matched healthy reference data to classify patients as healthy, pre-diseased, at risk, or diseased. Inventors include Paul John Innocenzi, Stephen Peter Fitzgerald, and Ivan Robert Mcconnell.

What changed

The patent application discloses a method for classifying biological status of an individual through health informatics. The method involves obtaining a biological sample and health-related information including patient gender, analyzing the sample to identify quantities of two or more endogenous analytes, and comparing these quantities to reference data from gender-matched healthy individuals. The process includes monitoring to maintain consistency. CPC classifications include G16H 10/40 (Health informatics for diagnosis), G16H 50/30 (Health informatics for classification of health status), and related categories.

This is a patent application publication, not a regulatory requirement. Medical device manufacturers and diagnostic companies should review the claims to assess potential IP implications for their own diagnostic technologies. No compliance actions or deadlines are associated with this document. Entities developing analyte-based diagnostic methods should consider freedom-to-operate analysis relative to the disclosed classification method.

Source document (simplified)

← USPTO Patent Applications

BIOLOGICAL STATUS CLASSIFICATION

Application US20260092926A1 Kind: A1 Apr 02, 2026

Inventors

Paul John Innocenzi, Stephen Peter Fitzgerald, Ivan Robert Mcconnell

Abstract

There is provided a method of classifying a biological status of an individual. The method comprising: obtaining a biological sample from a patient; obtaining health-related information from the patient, said information including patient gender; analysing the sample to identify a quantity of each of 2 or more endogenous analytes in the sample; comparing the analyte quantities to reference data from healthy individuals to classify the patient as healthy, pre-diseased, at risk of disease or diseased for at least one health-related condition. The reference data includes data derived from a group of biological samples of individuals having the same gender as the patient and not having a need for medical treatment for a disease or illness, each biological sample of the group of biological samples having been analysed by the same process as used to analyse the patient sample, the process being monitored to maintain a predetermined level of consistency.

CPC Classifications

G01N 33/68 G16H 10/40 G16H 20/60 G16H 50/30 G16H 70/60 G01N 2800/50

Filing Date

2025-12-05

Application No.

19410807

View original document →

Classification

Agency
USPTO
Published
April 2nd, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Draft
Change scope
Minor
Document ID
US20260092926A1

Who this affects

Applies to
Medical device makers Healthcare providers Pharmaceutical companies
Industry sector
3345 Medical Device Manufacturing
Activity scope
Diagnostic Method Development Health Informatics Biomarker Analysis
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Research and Development
Topics
Medical Devices Artificial Intelligence

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