Specialized Treatment Solutions for Cholestatic Diseases in Unique Environments

Publication ID: 24-11857523_0004_PTD
Published: October 28, 2025
Category:Specialized Variations & Niche Solutions

Legal Citation

pr1or.art Inc., “Specialized Treatment Solutions for Cholestatic Diseases in Unique Environments,” Published Technical Disclosure No. 24-11857523_0004_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857523_0004_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

Adapting elafibranor-based treatment methods for cholestatic diseases to cater to specific, high-need populations and operational environments, such as high-security settings, disaster relief situations, extreme weather conditions, remote areas, and high-altitude environments.

Background and Problem Solved

The original patent disclosed methods for treating cholestatic diseases, particularly PBC and PSC, using elafibranor. However, these methods may not be directly applicable to unique environments, where additional challenges and constraints exist. The present inventive concept addresses these limitations by developing specialized treatment solutions tailored to these niche scenarios.

Detailed Description of the Inventive Concept

The new inventive concept comprises a range of solutions, including secure, tamper-proof containers for high-security environments; compositions formulated for use in disaster relief settings; portable, weather-resistant devices for extreme weather conditions; satellite communication systems for remote, isolated areas; and formulations adapted for high-altitude environments. These solutions incorporate elafibranor as the active pharmaceutical ingredient, ensuring effective treatment of cholestatic diseases in these unique environments.

Novelty and Inventive Step

The new claims introduce novel, non-obvious variations of the original patent's methods, specifically designed to address the challenges and constraints of high-security, disaster relief, extreme weather, remote, and high-altitude environments. These specialized solutions provide a significant improvement over existing treatments, offering enhanced accessibility, security, and efficacy in these niche scenarios.

Alternative Embodiments and Variations

Alternative embodiments may include the use of different pharmaceutical ingredients, varying formulations, or alternative communication devices. Variations could also involve integrating these solutions with existing infrastructure, such as medical facilities or emergency response systems, to enhance their effectiveness.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in various industries, including pharmaceuticals, medical devices, and emergency response services. Target markets include government agencies, disaster relief organizations, and medical providers operating in high-security, remote, or extreme environments.

CPC Classifications

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

Field of Art

Pharmaceutical treatment of cholestatic diseases, specifically focused on therapeutic methods for primary biliary cholangitis (PBC) with emphasis on drug delivery systems and patient-specific treatment approaches

Person of Ordinary Skill (PHOSITA) Profile

A medical researcher or pharmaceutical formulation specialist with expertise in drug delivery, clinical pharmacology, and medical device design, possessing knowledge of pharmaceutical formulation techniques, patient treatment strategies, and adaptive medical technologies

Obviousness Rationale

A person having ordinary skill in the art would recognize that the specialized treatment environments represent predictable extensions of the source patent's core pharmaceutical method, applying standard pharmaceutical engineering principles to adapt the elafibranor treatment to specific contextual challenges. The variations demonstrate routine problem-solving by applying known pharmaceutical formulation and delivery techniques to unique environmental constraints. These adaptations represent standard design modifications within the pharmaceutical and medical device development domain.

Obvious Combinations & Variations

Source Patent Element
Composition comprising elafibranor for treating PBC with oral administration
PTD Variation
Specialized formulations for high-security, disaster relief, and extreme environment contexts
Obviousness Reasoning
A PHOSITA would recognize that pharmaceutical formulations require adaptive packaging and delivery mechanisms for different environmental conditions, using standard pharmaceutical engineering techniques
Source Patent Element
Method of administering medication for cholestatic disease treatment
PTD Variation
Integration of remote monitoring and satellite communication systems for medication administration
Obviousness Reasoning
Telemedicine and remote patient monitoring are well-established techniques in medical treatment, representing a predictable technological extension of existing treatment protocols
Source Patent Element
Pharmaceutical composition with specific dosage and administration parameters
PTD Variation
Formulations adapted for high-altitude and extreme environmental conditions
Obviousness Reasoning
Adjusting pharmaceutical compositions for physiological variations is a standard practice in medical research, representing a routine optimization process for drug delivery
Source Patent Element
Oral administration of elafibranor for PBC treatment
PTD Variation
Alternative delivery mechanisms including injectable suspension, gel, and specialized containers
Obviousness Reasoning
Exploring multiple drug delivery mechanisms is a standard approach in pharmaceutical development, representing predictable variations known to those skilled in the art
Source Patent Element
Treatment method for cholestatic diseases
PTD Variation
Specialized systems for secure, monitored medication administration in constrained environments
Obviousness Reasoning
Developing context-specific medical delivery systems represents a predictable engineering solution addressing known practical challenges in medication management
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857523 and the published technical disclosure, a person having ordinary skill in the art would find the claimed variations obvious, as they represent routine pharmaceutical engineering adaptations applying standard techniques to specialized treatment environments. The disclosed variations constitute prior art demonstrating that the claimed innovations would have been obvious to a person of ordinary skill at the time of invention, lacking the requisite non-obviousness for patent protection.

Original Patent Information

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