Specialized Therapeutic Protein Delivery Systems for Extreme Environments

Publication ID: 24-11857631_0004_PTD
Published: October 28, 2025
Category:Specialized Variations & Niche Solutions

Legal Citation

pr1or.art Inc., “Specialized Therapeutic Protein Delivery Systems for Extreme Environments,” Published Technical Disclosure No. 24-11857631_0004_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857631_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. 11,857,631.

Summary of the Inventive Concept

A novel, adaptable therapeutic protein delivery system designed for specific, high-stress operational environments, including high-altitude, disaster relief, high-security, extreme cold, and space exploration scenarios.

Background and Problem Solved

The original patent disclosed a composition for delivering multiple therapeutic proteins, but it lacked adaptability for unique operational environments. This inventive concept addresses the need for specialized delivery systems that can withstand and perform optimally in extreme conditions, ensuring effective wound healing and tissue repair.

Detailed Description of the Inventive Concept

The inventive concept comprises a hydrogel embedded with a complex or coacervate of a polycationic polymer, a polyanionic polymer, fibroblast growth factor 2 (FGF-2), and stromal cell-derived factor 1 alpha (SDF-1α). The polycationic polymer is adapted to withstand low oxygen levels, extreme temperatures, or microgravity conditions, depending on the specific application. The system is designed to be portable, ruggedized, tamper-evident, and resistant to unauthorized access, as required by the target environment.

Novelty and Inventive Step

The new claims introduce novel adaptations of the original composition, including the use of specialized polymers and packaging designs, to create a family of delivery systems tailored to specific extreme environments. This inventive step lies in the recognition of the need for environmental adaptability and the development of corresponding solutions.

Alternative Embodiments and Variations

Alternative embodiments may include varying the polymer composition, incorporating additional therapeutic proteins, or modifying the packaging design to accommodate different operational scenarios. Variations could also include integrating sensors or monitoring systems to track the delivery system's performance in real-time.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in various industries, including aerospace, defense, disaster relief, and extreme sports. The adaptability of the delivery system to unique operational environments opens up new markets and opportunities for partnerships with organizations operating in these areas.

CPC Classifications

SectionClassGroup
A A61 A61K47/36
A A61 A61K9/0019
A A61 A61K9/06
A A61 A61K35/16
A A61 A61K35/19
A A61 A61K38/177
A A61 A61K38/18
A A61 A61K38/1825
A A61 A61K38/195
A A61 A61K47/34
A A61 A61K47/42
A A61 A61L15/225
A A61 A61L15/40
A A61 A61L15/44
A A61 A61L27/18
A A61 A61L27/20
A A61 A61L27/225
A A61 A61L27/26
A A61 A61L27/3616
A A61 A61L27/52
A A61 A61L27/54
A A61 A61L27/56
A A61 A61L31/041
A A61 A61L31/042
A A61 A61L31/046
A A61 A61L31/145
A A61 A61L31/16
A A61 A61P9/10
A A61 A61L2300/25
A A61 A61L2300/252
A A61 A61L2300/414
A A61 A61L2300/418
A A61 A61L2400/04
A A61 A61L2430/20

Field of Art

Biomedical engineering, specifically protein delivery systems, biomaterials, and wound healing technologies with expertise in polymer chemistry, hydrogel formulations, and therapeutic protein stabilization

Person of Ordinary Skill (PHOSITA) Profile

A researcher or engineer with advanced degrees in biomedical engineering or related fields, possessing knowledge of polymer science, protein delivery mechanisms, and experience designing controlled release systems for therapeutic proteins

Obviousness Rationale

A person having ordinary skill would recognize that adapting the source patent's hydrogel-based protein delivery system to specific environmental conditions represents a predictable variation within the known design space of therapeutic protein delivery technologies. The core composition remains substantially similar, with modifications focused on environmental adaptability being well within the routine optimization capabilities of a skilled practitioner. The PTD's variations demonstrate standard engineering problem-solving by tailoring existing protein delivery technologies to meet specific operational requirements.

Obvious Combinations & Variations

Source Patent Element
Hydrogel composition with polycationic polymer, polyanionic polymer, and embedded therapeutic proteins (FGF-2, SDF-1α)
PTD Variation
Modifying polymer composition to withstand low oxygen, extreme temperatures, or microgravity conditions
Obviousness Reasoning
Adapting polymer properties for specific environmental conditions is a predictable design choice using known polymer engineering techniques, representing routine optimization of material properties
Source Patent Element
Complex or coacervate embedding multiple therapeutic proteins
PTD Variation
Packaging design for portable, ruggedized, tamper-evident delivery systems
Obviousness Reasoning
Modifying packaging to enhance transportability and security represents a standard engineering solution for protecting sensitive biological materials, utilizing known containment and preservation techniques
Source Patent Element
Wound healing composition with growth factors
PTD Variation
Targeted delivery systems for specific environments like high-altitude, disaster relief, and space exploration
Obviousness Reasoning
Identifying and addressing specialized medical delivery challenges is a predictable extension of existing protein delivery research, demonstrating standard problem-solving in biomedical engineering
Source Patent Element
Polycationic polymer with specific peptide sequences
PTD Variation
Incorporating environmental adaptation capabilities into polymer backbone
Obviousness Reasoning
Modifying polymer chemistry to enhance performance in extreme conditions represents a standard approach to materials engineering, utilizing known polymer modification techniques
Source Patent Element
Hydrogel-based therapeutic protein delivery system
PTD Variation
Integration of monitoring systems to track delivery system performance
Obviousness Reasoning
Adding sensor or monitoring capabilities to medical delivery systems is a predictable technological improvement within the state of the art in biomedical engineering
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857631, the present publication demonstrates that variations in therapeutic protein delivery systems targeting specific environmental conditions would be obvious to a person having ordinary skill in the art. The disclosed modifications represent routine engineering optimization of known protein delivery technologies, utilizing predictable combinations of existing techniques to address specific operational challenges.

Original Patent Information

Patent NumberUS 11,857,631
TitleProtection and delivery of multiple therapeutic proteins
Assignee(s)UNIVERSITY OF PITTSBURGH—OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION