Personalized Cholestatic Disease Management System

Publication ID: 24-11857523_0010_PTD
Published: October 28, 2025
Category:Future Evolutions & Paradigm Shifts

Legal Citation

pr1or.art Inc., “Personalized Cholestatic Disease Management System,” Published Technical Disclosure No. 24-11857523_0010_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857523_0010_PTD
This technical disclosure describes improvements that would be readily apparent to a Person Having Ordinary Skill In The Art (PHOSITA) when considered in combination with the foundational architecture disclosed in U.S. Patent No. 11,857,523.

Summary of the Inventive Concept

A comprehensive system for personalized treatment of cholestatic diseases, integrating biomarkers, tailored therapy selection, and real-time monitoring to improve treatment outcomes and patient quality of life.

Background and Problem Solved

The original patent relates to methods of treatment of cholestatic diseases, specifically PBC and/or PSC. However, these treatments often have inadequate response rates, and there is a need for more effective and personalized approaches. The new inventive concept addresses this limitation by providing a system that takes into account individual patient profiles, biomarkers, and treatment response data to deliver optimized treatment regimens.

Detailed Description of the Inventive Concept

The system comprises a biomarker panel for identifying a patient's specific disease profile, a tailored therapy selection module for determining an optimal treatment regimen based on the patient's profile, and a device for non-invasive, real-time monitoring of bile flow and composition. The system may also include a computer-implemented method for identifying novel therapeutic targets, a personalized nutrition and lifestyle planning system, and a method for predicting treatment outcomes. These components work together to provide a comprehensive and adaptive approach to managing cholestatic diseases.

Novelty and Inventive Step

The new inventive concept introduces a paradigm shift in cholestatic disease treatment by integrating multiple components to deliver personalized medicine. The use of biomarkers, tailored therapy selection, and real-time monitoring is a novel combination that goes beyond the original patent's methods. The inventive step lies in the system's ability to adapt to individual patient needs and provide optimized treatment regimens.

Alternative Embodiments and Variations

Alternative embodiments of the system may include variations in the biomarker panel, therapy selection algorithms, or monitoring devices. For example, the system could incorporate additional biomarkers, such as genetic or epigenetic markers, or utilize machine learning algorithms to predict treatment outcomes. Other variations may include different types of monitoring devices, such as implantable sensors or mobile apps.

Potential Commercial Applications and Market

The personalized cholestatic disease management system has significant commercial potential in the healthcare industry, particularly in the areas of precision medicine and digital health. The system could be marketed to pharmaceutical companies, healthcare providers, and patients with cholestatic diseases, offering a new standard of care and improved treatment outcomes.

CPC Classifications

SectionClassGroup
A A61 A61K31/192
A A61 A61K45/06
A A61 A61P37/06

Field of Art

Medical biotechnology focused on hepatic disease treatment, specifically cholestatic disorders, requiring expertise in pharmacology, diagnostic technologies, personalized medicine, and medical data analytics

Person of Ordinary Skill (PHOSITA) Profile

A medical researcher or clinical specialist with advanced degrees in medical sciences, proficient in molecular diagnostics, therapeutic development, patient monitoring technologies, and computational biology techniques

Obviousness Rationale

A PHOSITA would recognize that the personalized treatment system represents a natural progression of precision medicine principles applied to cholestatic disease management. The integration of biomarker analysis, tailored therapy selection, and real-time monitoring are logical extensions of existing medical technology frameworks. The disclosed system combines well-known diagnostic and treatment optimization strategies into a comprehensive approach that would be predictable to an expert in the field.

Obvious Combinations & Variations

Source Patent Element
Method for treating pruritus associated with cholestatic diseases
PTD Variation
Biomarker panel and tailored therapy selection module for optimizing treatment regimens
Obviousness Reasoning
Personalized medicine approaches are a known technique for refining disease management, with predictable benefits in identifying optimal treatment strategies based on individual patient characteristics
Source Patent Element
Pharmaceutical composition for cholestatic disease treatment
PTD Variation
Machine learning algorithm for identifying novel therapeutic targets using genomic and proteomic data
Obviousness Reasoning
Computational methods for drug target discovery are standard practice in pharmaceutical research, representing an obvious application of computational biology techniques to expand therapeutic understanding
Source Patent Element
Administration methods for cholestatic disease treatments
PTD Variation
Non-invasive, real-time monitoring device for tracking bile flow and composition
Obviousness Reasoning
Development of advanced patient monitoring technologies is a predictable evolution in medical diagnostic techniques, particularly for chronic disease management
Source Patent Element
Treatment of cholestatic diseases with specific pharmaceutical compositions
PTD Variation
Personalized nutrition and lifestyle recommendation system integrated with disease management
Obviousness Reasoning
Holistic patient care approaches that combine medical treatment with lifestyle interventions are a known and expected strategy in modern medical practice
Source Patent Element
Pharmaceutical treatment for cholestatic diseases
PTD Variation
Predictive treatment outcome scoring using genetic, epigenetic, and historical patient data
Obviousness Reasoning
Developing predictive models for treatment efficacy is a standard approach in personalized medicine, representing an obvious application of data analytics to clinical decision-making
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857523 and the principles of personalized medicine, the disclosed technical variations represent obvious extensions of existing cholestatic disease treatment methodologies. A person having ordinary skill in the art would find the combination of biomarker analysis, computational target identification, patient monitoring technologies, and comprehensive treatment optimization to be predictable and within the ordinary capabilities of medical researchers in the field of hepatic disease management.

Original Patent Information

Patent NumberUS 11,857,523
TitleMethods of treatment of cholestatic diseases
Assignee(s)Genfit