Specialized Therapeutic Solutions for Cholestatic Diseases in Unique Operational Environments

Publication ID: 24-11857523_0009_PTD
Published: October 28, 2025
Category:Specialized Variations & Niche Solutions

Legal Citation

pr1or.art Inc., “Specialized Therapeutic Solutions for Cholestatic Diseases in Unique Operational Environments,” Published Technical Disclosure No. 24-11857523_0009_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857523_0009_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

The inventive concept adapts the original method of treating cholestatic diseases for specific, narrow markets or unique operational environments, providing targeted therapeutic solutions for high-altitude, disaster relief, high-security, and extreme weather settings.

Background and Problem Solved

The original patent addresses the treatment of cholestatic diseases, primarily PBC and PSC. However, the original method may not be effective or practical in unique operational environments, such as high-altitude, disaster relief, high-security, or extreme weather settings, where subjects may have compromised respiratory, immune, or other systems. The new inventive concept solves this problem by providing specialized therapeutic solutions tailored to these specific environments.

Detailed Description of the Inventive Concept

The inventive concept comprises a set of specialized methods and systems for treating cholestatic diseases in unique operational environments. In a high-altitude environment, the method administers a therapeutically effective amount of a composition comprising elafibranor to a subject with a compromised respiratory system. In a disaster relief setting, the system includes a portable device for administering elafibranor and a power source operable in a low-infrastructure environment. For subjects with compromised immune systems, the method combines elafibranor with an immunomodulator. In high-security environments, the system features a secure storage unit for elafibranor and a biometric authentication device for authorized access. For subjects with a history of extreme weather exposure, the method incorporates an antioxidant with elafibranor.

Novelty and Inventive Step

The new claims introduce novel and non-obvious adaptations of the original method to address the specific challenges of unique operational environments. The inventive concept's novelty lies in its tailored approach to treating cholestatic diseases in these environments, which is not addressed by the original patent.

Alternative Embodiments and Variations

Alternative embodiments may include variations of the composition, dosage, or administration route, as well as modifications to the portable device, power source, secure storage unit, or biometric authentication device. Additionally, the inventive concept could be adapted for other unique operational environments, such as space exploration or remote wilderness areas.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in the pharmaceutical and medical device industries, particularly in niche markets catering to high-altitude, disaster relief, high-security, and extreme weather environments. Target industries may include military, aerospace, emergency response, and specialized healthcare providers.

CPC Classifications

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

Field of Art

Medical therapeutics, specifically pharmaceutical interventions for cholestatic liver diseases, with expertise in drug formulation, administration methods, and targeted treatment strategies

Person of Ordinary Skill (PHOSITA) Profile

A medical researcher or clinical pharmacologist with advanced training in hepatology, pharmaceutical sciences, and drug delivery technologies, capable of understanding complex medical treatment protocols and adapting therapeutic approaches to specialized environments

Obviousness Rationale

A person having ordinary skill in the art would recognize that the PTD's variations represent predictable extensions of the source patent's core therapeutic method, applying standard pharmaceutical adaptation techniques to address specific environmental and physiological challenges while maintaining the fundamental treatment approach of using elafibranor for cholestatic diseases.

Obvious Combinations & Variations

Source Patent Element
Method of administering elafibranor for treating cholestatic diseases
PTD Variation
Adapting administration for high-altitude environments with compromised respiratory systems
Obviousness Reasoning
A PHOSITA would recognize that modifying drug delivery for specific physiological conditions is a routine pharmaceutical design choice, particularly when the core therapeutic mechanism remains unchanged
Source Patent Element
Flexible formulation options for drug administration
PTD Variation
Portable device for administering elafibranor in disaster relief settings
Obviousness Reasoning
Developing specialized drug delivery systems for challenging environments is a predictable solution within pharmaceutical engineering, leveraging known techniques for portable medical interventions
Source Patent Element
Composition comprising elafibranor for treating cholestatic diseases
PTD Variation
Combining elafibranor with an immunomodulator for subjects with compromised immune systems
Obviousness Reasoning
Combining pharmaceutical agents to address specific patient conditions is a standard approach in medical treatment, representing an obvious variation to a skilled practitioner
Source Patent Element
Multiple administration routes for cholestatic disease treatment
PTD Variation
Secure storage and biometric authentication for drug administration in high-security environments
Obviousness Reasoning
Implementing access control and specialized storage for pharmaceutical interventions is a predictable solution for managing sensitive medical treatments
Source Patent Element
Composition for treating cholestatic diseases
PTD Variation
Adding antioxidants for subjects with extreme weather exposure history
Obviousness Reasoning
Supplementing pharmaceutical compositions with complementary compounds to address specific physiological conditions is a routine optimization strategy in medical research
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857523, a person having ordinary skill in the art would find the variations disclosed in this publication to be obvious extensions of the prior art, representing predictable adaptations of known therapeutic methods for treating cholestatic diseases across diverse environmental and physiological contexts, thereby rendering potential claims to such variations unpatentable under 35 U.S.C. ยง 103.

Original Patent Information

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