Self-Regulated Release of Active Pharmaceutical Ingredient for Niche Applications

Publication ID: 24-11857629_0004_PTD
Published: October 28, 2025
Category:Specialized Variations & Niche Solutions

Legal Citation

pr1or.art Inc., “Self-Regulated Release of Active Pharmaceutical Ingredient for Niche Applications,” Published Technical Disclosure No. 24-11857629_0004_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857629_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. 11,857,629.

Summary of the Inventive Concept

This inventive concept adapts the original self-regulated release technology for specialized markets, such as disaster relief, high-security environments, extreme weather conditions, remote medical assistance, and areas with limited medical resources.

Background and Problem Solved

The original patent addressed the need for abuse deterrent pharmaceutical compositions. However, these compositions may not be suitable for specific, narrow markets or unique operational environments. This inventive concept solves the problem by adapting the self-regulated release technology to cater to these niche applications.

Detailed Description of the Inventive Concept

The inventive concept comprises specialized variations of the original pharmaceutical composition, including a portable container with a water purification system for disaster relief, a secure, tamper-evident monitoring system for high-security environments, a moisture-resistant coating with a desiccant for extreme weather conditions, a telemedicine platform for remote medical assistance, and educational materials for areas with limited medical resources. These variations ensure the safe and effective administration of the pharmaceutical composition in these unique environments.

Novelty and Inventive Step

The new claims introduce novel and non-obvious adaptations of the original self-regulated release technology, including the integration of water purification systems, secure monitoring systems, moisture-resistant coatings, telemedicine platforms, and educational materials. These adaptations provide a new level of safety and efficacy in niche applications, distinguishing the inventive concept from the original patent.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include using different types of containers, monitoring systems, or coatings, or integrating additional features such as GPS tracking or biometric authentication. Variations could also include adapting the pharmaceutical composition for different types of medications or diseases.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in various industries, including disaster relief, healthcare, pharmaceuticals, and medical technology. The target markets include governments, NGOs, hospitals, clinics, and pharmaceutical companies operating in niche environments.

CPC Classifications

SectionClassGroup
A A61 A61K47/02
A A61 A61K9/2009
A A61 A61K9/2027
A A61 A61K9/2077
A A61 A61K31/5517
A A61 A61K47/32

Field of Art

Pharmaceutical formulation and drug delivery systems, with specialized expertise in abuse-deterrent medication design, controlled release technologies, and pharmaceutical composition modification

Person of Ordinary Skill (PHOSITA) Profile

A pharmaceutical scientist or formulation engineer with advanced degree, experience in drug delivery system design, knowledge of controlled release mechanisms, and understanding of pharmaceutical packaging and administration technologies

Obviousness Rationale

A PHOSITA would recognize that the source patent's core technology of self-regulated pharmaceutical release provides a foundational framework for adapting the composition to specialized environments. The PTD's variations represent predictable extensions of the original abuse-deterrent technology, applying known pharmaceutical engineering principles to solve contextual administration challenges. The modifications demonstrate standard problem-solving approaches within pharmaceutical design, utilizing well-established techniques of packaging, monitoring, and environmental protection.

Obvious Combinations & Variations

Source Patent Element
Abuse-deterrent pharmaceutical composition with controlled release mechanism
PTD Variation
Portable container with integrated water purification system for disaster relief scenarios
Obviousness Reasoning
A PHOSITA would recognize that ensuring medication stability and safe administration in challenging environments is a predictable design optimization using known packaging and purification technologies
Source Patent Element
Pharmaceutical composition with buffering ingredients to modulate drug release
PTD Variation
Moisture-resistant coating with desiccant for extreme weather condition preservation
Obviousness Reasoning
Protecting pharmaceutical compositions from environmental degradation represents a standard engineering solution using known moisture barrier and preservation techniques
Source Patent Element
Composition designed to suppress peak plasma concentration
PTD Variation
Telemedicine platform for remote monitoring of pharmaceutical administration
Obviousness Reasoning
Integrating remote monitoring technologies with controlled-release pharmaceuticals represents a predictable technological convergence addressing patient safety and medication management
Source Patent Element
Pharmaceutical composition for drugs with narrow therapeutic index
PTD Variation
Educational materials for safe handling in areas with limited medical resources
Obviousness Reasoning
Developing patient education materials to support safe medication use is a standard risk mitigation strategy in pharmaceutical design, particularly for complex drug formulations
Source Patent Element
Abuse-deterrent composition with specific release characteristics
PTD Variation
Secure, tamper-evident monitoring system for high-security pharmaceutical administration
Obviousness Reasoning
Implementing additional security and monitoring mechanisms represents a predictable enhancement to existing pharmaceutical delivery technologies
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857629, the variations disclosed herein represent obvious extensions of the original pharmaceutical composition technology, demonstrating that a person having ordinary skill in the art would find the claimed innovations predictable and non-inventive when viewed in light of the prior art. The systematic adaptation of controlled-release pharmaceutical technologies to specialized environmental and administrative contexts does not rise to the level of non-obvious innovation required for patent protection.

Original Patent Information

Patent NumberUS 11,857,629
TitleMethods and compositions for self-regulated release of active pharmaceutical ingredient
Assignee(s)Acurx Pharmaceuticals, Inc.