Enhanced Wound Healing System with Controlled Release of Multiple Therapeutic Proteins

Publication ID: 24-11857631_0001_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Wound Healing System with Controlled Release of Multiple Therapeutic Proteins,” Published Technical Disclosure No. 24-11857631_0001_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857631_0001_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 system for delivering multiple therapeutic proteins to enhance wound healing, featuring a hydrogel with a controlled release profile modulated by pH-dependent coacervates of polycationic and polyanionic polymers.

Background and Problem Solved

The original patent disclosed a composition comprising a hydrogel with embedded coacervates of multiple therapeutic proteins. However, the release profile of these proteins was not controlled, which limited the efficacy of the treatment. The new inventive concept addresses this limitation by introducing a pH-dependent coacervate that modulates the release profile, ensuring a more efficient and effective wound healing process.

Detailed Description of the Inventive Concept

The enhanced wound healing system consists of a hydrogel matrix with embedded coacervates of multiple therapeutic proteins, including fibroblast growth factor 2 (FGF-2) and stromal cell-derived factor 1 alpha (SDF-1α). The coacervates are formed by the interaction of polycationic and polyanionic polymers, which are designed to respond to changes in pH. As the wound environment changes, the pH-dependent coacervates release the therapeutic proteins in a controlled and sequential manner, mimicking the natural wound healing process. This controlled release profile ensures that the proteins are delivered at the optimal time and concentration, enhancing the wound healing response.

Novelty and Inventive Step

The new inventive concept introduces a novel pH-dependent coacervate that modulates the release profile of the therapeutic proteins, which is not disclosed in the original patent. This controlled release profile is a significant improvement over the original composition, as it ensures a more efficient and effective wound healing process.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept include the use of different types of polymers, such as polyethylene glycol or chitosan, to form the coacervates. Additionally, the system could be designed to release other therapeutic proteins or growth factors, such as vascular endothelial growth factor (VEGF) or keratinocyte growth factor (KGF).

Potential Commercial Applications and Market

The enhanced wound healing system has significant commercial potential in the wound care market, which is projected to reach $22.8 billion by 2025. The system could be used in a variety of clinical settings, including hospitals, clinics, and long-term care facilities, to treat acute and chronic wounds.

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 wound healing technologies, biomaterials, protein delivery systems, and controlled release formulations involving hydrogel matrices and protein complexation

Person of Ordinary Skill (PHOSITA) Profile

A biomedical engineer or materials scientist with expertise in polymer chemistry, protein therapeutics, and drug delivery systems, holding a PhD or equivalent advanced degree with 3-5 years of specialized research experience in biomaterial design and protein delivery technologies

Obviousness Rationale

A PHOSITA would recognize that the PTD's pH-dependent coacervate release mechanism represents a predictable extension of the source patent's protein delivery hydrogel system. The core technical elements of protein complexation, hydrogel embedding, and controlled release are substantially similar between the source patent and PTD. The modifications introduce incremental improvements that would be considered routine optimization within the field of controlled protein delivery systems.

Obvious Combinations & Variations

Source Patent Element
Hydrogel composition with embedded protein complex using polycationic and polyanionic polymers
PTD Variation
Introduction of pH-responsive coacervate design to modulate protein release profile
Obviousness Reasoning
Controlling protein release through polymer interactions is a known technique in drug delivery, and a PHOSITA would find it obvious to modify existing systems to achieve more precise temporal release characteristics
Source Patent Element
Composition containing FGF-2 and SDF-1α proteins embedded in hydrogel
PTD Variation
Sequential release mechanism mimicking natural wound healing progression
Obviousness Reasoning
Designing protein delivery systems to match biological processes is a standard approach in tissue engineering, representing a predictable design choice for a skilled practitioner
Source Patent Element
Polycationic polymer with specific peptide sequences
PTD Variation
Alternative polymer compositions like polyethylene glycol and chitosan for coacervate formation
Obviousness Reasoning
Selection of polymers with similar chemical properties is a routine design optimization that would be obvious to a PHOSITA familiar with polymer-protein interactions
Source Patent Element
Complex formation of proteins using polymer interactions
PTD Variation
Incorporation of environmental sensing mechanisms to dynamically adjust protein release
Obviousness Reasoning
Adaptive drug delivery systems are a known technological trend, and integrating sensing capabilities would be an obvious technological progression for a skilled researcher
Source Patent Element
Wound healing protein delivery system
PTD Variation
Expanded protein repertoire including VEGF and KGF in the delivery matrix
Obviousness Reasoning
Substituting or expanding the range of therapeutic proteins is a predictable variation within protein delivery technologies, representing a finite set of known protein candidates
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857631 and the disclosed variations, a person of ordinary skill in the art would find the claimed innovations obvious and therefore unpatentable. The incremental modifications to protein delivery systems represent routine optimization within the field of biomaterial design, lacking the requisite non-obviousness for patent protection under 35 U.S.C. § 103.

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