Enhanced Protection and Delivery of Multiple Therapeutic Proteins

Publication ID: 24-11857631_0006_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Protection and Delivery of Multiple Therapeutic Proteins,” Published Technical Disclosure No. 24-11857631_0006_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857631_0006_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

An improved system for delivering multiple therapeutic proteins, including FGF-2 and SDF-1α, to wound sites, enhancing wound healing and tissue repair by providing a sustained release of growth factors over a period of time.

Background and Problem Solved

The original patent disclosed a composition for delivering multiple therapeutic proteins, but it had limitations in terms of stability, controlled release, and targeted delivery. The new inventive concept addresses these limitations by introducing a biodegradable linker for cross-linking the hydrogel, modifying the polycationic polymer with a targeting moiety, and designing the composition for controlled release over a period of time.

Detailed Description of the Inventive Concept

The new inventive concept comprises a hydrogel and a complex or coacervate of a polycationic polymer, a polyanionic polymer, FGF-2, and SDF-1α embedded in the hydrogel. The hydrogel is cross-linked with a biodegradable linker to enhance the stability of the complex or coacervate. The polycationic polymer is modified with a targeting moiety to enhance the delivery of the growth factors to the wound site. The composition is designed to release the growth factors in a controlled manner over a period of time, providing a sustained release of the growth factors to the wound site. This improves wound healing and tissue repair by promoting a more efficient and effective delivery of therapeutic proteins.

Novelty and Inventive Step

The new inventive concept introduces a biodegradable linker for cross-linking the hydrogel, modifies the polycationic polymer with a targeting moiety, and designs the composition for controlled release over a period of time. These features are not present in the original patent and provide a novel and non-obvious solution to the limitations of the original patent.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include using different types of biodegradable linkers, modifying the polycationic polymer with different targeting moieties, or using different ratios of polycationic to polyanionic polymers. Additionally, the composition could be designed to release the growth factors in response to specific stimuli, such as pH or temperature changes.

Potential Commercial Applications and Market

The new inventive concept has potential commercial applications in the wound healing and tissue repair industries, including treatment of chronic wounds, burns, and surgical wounds. The market for wound healing products is expected to grow significantly in the coming years, and the new inventive concept has the potential to capture a significant share of this market.

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

Biomaterials and drug delivery systems, specifically focused on protein therapeutics, wound healing technologies, and controlled release hydrogel compositions with growth factors

Person of Ordinary Skill (PHOSITA) Profile

A biomedical engineer or materials scientist with expertise in polymer chemistry, protein formulation, and tissue regeneration technologies, holding advanced degrees and practical experience in designing drug delivery systems

Obviousness Rationale

A PHOSITA would recognize that the PTD's modifications to the source patent represent predictable engineering variations in controlled protein delivery systems. The addition of a biodegradable linker, targeting moiety, and controlled release mechanism are standard design approaches in biomaterial drug delivery technologies. These incremental improvements would be considered obvious extensions of the existing wound healing protein delivery strategy disclosed in the source patent.

Obvious Combinations & Variations

Source Patent Element
Hydrogel composition with embedded protein complex containing FGF-2 and SDF-1α
PTD Variation
Adding a biodegradable cross-linking mechanism to enhance hydrogel stability
Obviousness Reasoning
Cross-linking hydrogels is a known technique for improving mechanical properties and controlled release, representing a predictable optimization for protein delivery systems
Source Patent Element
Polycationic polymer with specific peptide sequences
PTD Variation
Modifying polycationic polymer with additional targeting moieties
Obviousness Reasoning
Enhancing polymer targeting is a standard approach in drug delivery to improve localization and cellular uptake, using well-established molecular engineering principles
Source Patent Element
Complex of polycationic and polyanionic polymers with growth factors
PTD Variation
Designing composition for stimulus-responsive controlled release
Obviousness Reasoning
Creating responsive drug delivery systems with environmental triggers is a known strategy in biomaterials, representing an obvious design choice for a skilled practitioner
Source Patent Element
Wound healing protein composition
PTD Variation
Implementing sustained release mechanism over extended time periods
Obviousness Reasoning
Extending protein half-life through controlled release is a predictable solution to improve therapeutic efficacy, using standard encapsulation and polymer engineering techniques
Source Patent Element
Hydrogel embedding of protein complexes
PTD Variation
Adjusting polymer ratios and incorporating additional targeting strategies
Obviousness Reasoning
Optimizing polymer composition and delivery mechanisms represents routine experimentation for a PHOSITA seeking incremental improvements in drug delivery technologies
35 U.S.C. § 103 Summary: Pursuant to 35 U.S.C. § 103, the variations disclosed in this publication would have been obvious to a person having ordinary skill in the art at the time of invention, with a reasonable expectation of success, based on the teachings of US Patent 11857631. The incremental modifications to protein delivery systems represent predictable engineering solutions within the established technological framework of controlled biomaterial drug delivery, thereby rendering potential patent claims obvious and anticipatable.

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