Personalized Cholestatic Disease Management Platform

Publication ID: 24-11857523_0005_PTD
Published: October 28, 2025
Category:Future Evolutions & Paradigm Shifts

Legal Citation

pr1or.art Inc., “Personalized Cholestatic Disease Management Platform,” Published Technical Disclosure No. 24-11857523_0005_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857523_0005_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 diagnosing, treating, and managing cholestatic diseases through personalized treatment plans, real-time monitoring, and predictive analytics, revolutionizing the standard of care for patients with PBC and PSC.

Background and Problem Solved

The original patent addressed the treatment of cholestatic diseases, specifically PBC and PSC, with a focus on pharmaceutical interventions. However, the limitations of these treatments, including inadequate response rates and side effects, highlight the need for a more holistic and patient-centric approach. The present inventive concept addresses these limitations by introducing a personalized disease management platform that integrates diagnostic, therapeutic, and monitoring components to provide a tailored treatment experience for each patient.

Detailed Description of the Inventive Concept

The proposed platform consists of four interconnected modules: 1) a diagnostic module for identifying a patient's specific disease subtype and response to existing therapies; 2) a treatment planning module for generating a customized treatment plan based on the patient's profile; 3) a monitoring module for tracking treatment efficacy and adjusting the treatment plan accordingly; and 4) a predictive analytics module for forecasting treatment outcomes and identifying potential complications. The platform leverages machine learning algorithms, real-world evidence, and biomarker data to provide a precise and adaptive treatment approach. Additionally, the platform includes a wearable device for real-time bile flow monitoring, a personalized nutrition and lifestyle planning system, and a closed-loop system for optimizing treatment based on patient data and predictive modeling.

Novelty and Inventive Step

The present inventive concept introduces a paradigm shift in the treatment of cholestatic diseases by moving from a one-size-fits-all pharmaceutical approach to a personalized, data-driven, and adaptive management platform. The integration of diagnostic, therapeutic, and monitoring components, combined with predictive analytics and machine learning, provides a novel and non-obvious solution that addresses the limitations of existing treatments.

Alternative Embodiments and Variations

Alternative embodiments of the platform could include varying the types of diagnostic tests, treatment modalities, and monitoring devices used. Additionally, the platform could be adapted for use in other diseases characterized by impaired bile flow or liver function. Variations of the predictive analytics module could incorporate different machine learning algorithms or data sources to improve treatment outcome forecasting.

Potential Commercial Applications and Market

The personalized cholestatic disease management platform has significant commercial potential in the pharmaceutical, medical device, and healthcare industries. The platform could be marketed as a comprehensive disease management solution for patients with PBC and PSC, offering a competitive advantage over existing treatments. The market potential is substantial, with an estimated 1.5 million patients worldwide living with PBC and PSC.

CPC Classifications

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

Field of Art

Medical technology and pharmaceutical treatment systems, specifically focused on cholestatic disease management, involving interdisciplinary expertise in hepatology, medical informatics, personalized medicine, and digital health technologies

Person of Ordinary Skill (PHOSITA) Profile

A skilled practitioner with advanced degrees in medical sciences, proficient in data analytics, machine learning applications in healthcare, and understanding of liver disease treatment protocols, with knowledge of emerging personalized medicine approaches

Obviousness Rationale

Given the source patent's focus on cholestatic disease treatment methods, a PHOSITA would recognize that expanding treatment approaches through data-driven personalization and monitoring technologies represents a natural progression in medical innovation. The platform's integration of diagnostic, treatment, and monitoring modules follows established trends in precision medicine. The technical variations represent predictable combinations of known medical informatics techniques applied to a specific disease management context.

Obvious Combinations & Variations

Source Patent Element
Method for treating pruritus associated with cholestatic diseases
PTD Variation
Comprehensive personalized treatment platform with diagnostic and monitoring modules
Obviousness Reasoning
Extending pharmaceutical treatment to include comprehensive patient management is a predictable evolution in precision medicine, utilizing known data analytics and machine learning techniques
Source Patent Element
Pharmaceutical composition for cholestatic disease treatment
PTD Variation
Wearable biosensor for real-time bile flow monitoring
Obviousness Reasoning
Integrating continuous monitoring technologies with pharmaceutical treatments is a known approach in personalized medicine, representing an obvious technological enhancement
Source Patent Element
Treatment method for PBC and PSC
PTD Variation
Machine learning-based predictive analytics for treatment outcome forecasting
Obviousness Reasoning
Applying machine learning to medical treatment prediction is a well-established technique, representing a straightforward technological extension of existing medical research methodologies
Source Patent Element
Oral administration of therapeutic composition
PTD Variation
Personalized nutrition and lifestyle planning system integrated with treatment protocol
Obviousness Reasoning
Expanding pharmaceutical treatment to include holistic lifestyle management is a predictable approach in modern personalized medicine, utilizing known nutritional science and patient engagement techniques
Source Patent Element
Treatment for cholestatic diseases with specific pharmaceutical compositions
PTD Variation
Closed-loop system for real-time treatment optimization using integrated patient data
Obviousness Reasoning
Creating adaptive treatment systems using comprehensive patient data represents an obvious technological progression in personalized medical care, leveraging established data integration and decision support methodologies
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857523 and the disclosed technical variations, a person having ordinary skill in the art would find the proposed personalized cholestatic disease management platform obvious, as it represents a predictable combination of known medical informatics techniques, monitoring technologies, and treatment methodologies applied to a specific disease management context. The variations constitute obvious extensions of existing medical treatment approaches, rendering potential patent claims obvious under 35 U.S.C. Section 103.

Original Patent Information

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