Novel Therapeutic Protein Delivery Systems for Respiratory, Skin, and Eye Diseases

Publication ID: 24-11857631_0002_PTD
Published: October 28, 2025
Category:New Applications & Use Cases

Legal Citation

pr1or.art Inc., “Novel Therapeutic Protein Delivery Systems for Respiratory, Skin, and Eye Diseases,” Published Technical Disclosure No. 24-11857631_0002_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857631_0002_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

This inventive concept leverages the core technology of the original patent to develop novel therapeutic protein delivery systems for treating respiratory diseases, skin conditions, and eye diseases, offering a more targeted and sustained approach to protein therapy.

Background and Problem Solved

The original patent's technology, while effective for wound healing, has limitations in terms of protein half-life and dosing requirements. This new concept addresses these limitations by applying the core technology to different industries, specifically respiratory, skin, and eye diseases, where sustained protein delivery is crucial for effective treatment.

Detailed Description of the Inventive Concept

The new claims describe systems, methods, and devices for delivering therapeutic proteins to lung tissue, skin, and eye tissue using polymer compositions comprising polycationic and polyanionic polymers. The polyanionic polymer is heparin or heparan sulfate, and the therapeutic proteins are selected from vascular endothelial growth factor (VEGF), keratinocyte growth factor (KGF), fibroblast growth factor 2 (FGF-2), and stromal cell-derived factor 1 alpha (SDF-1α). These compositions enable sustained protein delivery over a period of at least 24 hours, reducing the need for frequent dosing and improving treatment outcomes.

Novelty and Inventive Step

The new claims introduce novel applications and use cases for the original patent's technology, expanding its scope to address unmet needs in respiratory, skin, and eye diseases. The inventive step lies in the adaptation of the core technology to these new fields, resulting in a more targeted and effective approach to protein therapy.

Alternative Embodiments and Variations

Alternative embodiments could include varying the polymer composition, therapeutic protein selection, or delivery device design to accommodate different disease indications or patient needs. For example, a variant could incorporate additional therapeutic agents or adjust the polymer's polydispersity index to optimize protein release kinetics.

Potential Commercial Applications and Market

This inventive concept has significant commercial potential in the respiratory, skin, and eye disease markets, where there is a growing demand for more effective and targeted protein therapies. The market for respiratory disease treatments alone is projected to reach $XX billion by 20XX, and the skin and eye disease markets are also expected to experience significant growth.

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 and pharmaceutical delivery systems, specifically focused on protein therapeutics, polymer-based drug delivery, and tissue regeneration technologies

Person of Ordinary Skill (PHOSITA) Profile

A biomedical engineer or pharmaceutical scientist with expertise in polymer chemistry, protein stabilization, controlled drug delivery systems, and tissue engineering, holding at least a master's degree with 3-5 years of research experience in biomaterials and protein therapeutics

Obviousness Rationale

A person having ordinary skill in the art would recognize that the published technical disclosure represents a straightforward extension of the source patent's core technology by applying the established polymer-protein complex delivery system to additional tissue types and disease indications. The fundamental molecular mechanisms and polymer compositions remain substantially consistent, with the primary innovation being the targeted application to respiratory, skin, and eye tissues. These variations represent predictable adaptations of a known therapeutic protein delivery platform to address specific clinical needs.

Obvious Combinations & Variations

Source Patent Element
Hydrogel composition with polycationic and polyanionic polymers containing therapeutic proteins
PTD Variation
Expanding protein delivery to lung, skin, and eye tissues using same polymer complex technology
Obviousness Reasoning
Known polymer delivery platform can be readily adapted to different tissue targets using standard biomedical engineering techniques, representing a predictable design variation
Source Patent Element
Complex containing fibroblast growth factor 2 (FGF-2) and stromal cell-derived factor 1 alpha (SDF-1α)
PTD Variation
Introducing VEGF and KGF as alternative therapeutic proteins in similar polymer complexes
Obviousness Reasoning
Substituting growth factors within established polymer delivery systems is a routine optimization strategy in protein therapeutic development
Source Patent Element
Polycationic polymer with specific peptide sequences like IKVAV and RGD
PTD Variation
Modifying polymer composition to enhance tissue-specific targeting and protein release kinetics
Obviousness Reasoning
Adjusting polymer chemistry to improve therapeutic performance is a standard approach for a skilled practitioner seeking to optimize drug delivery systems
Source Patent Element
Initial wound healing protein delivery approach
PTD Variation
Extending delivery method to specific disease contexts like COPD and chronic wound treatment
Obviousness Reasoning
Translating a generalized therapeutic platform to specific disease indications represents a logical and foreseeable technological progression
Source Patent Element
Hydrogel-based protein complex delivery system
PTD Variation
Creating sustained release mechanisms targeting 24-hour protein delivery across different tissue types
Obviousness Reasoning
Modifying release kinetics through polymer composition is a well-established technique in controlled drug delivery research
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857631, a person having ordinary skill in the art would find the claimed variations in protein delivery systems to respiratory, skin, and eye tissues to be obvious extensions of the prior art, lacking inventive step under 35 U.S.C. § 103. The published technical disclosure demonstrates that the core polymer-protein complex technology can be predictably adapted to new therapeutic contexts using routine biomedical engineering techniques, thereby rendering subsequent claims of novelty invalid.

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