Novel Therapeutic Protein Delivery Systems for Respiratory, Skin, and Eye Diseases
Legal Citation
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
| Section | Class | Group |
|---|---|---|
| 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 |
Section 103 Obviousness Analysis (PHOSITA)
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
Original Patent Information
| Patent Number | US 11,857,631 |
|---|---|
| Title | Protection and delivery of multiple therapeutic proteins |
| Assignee(s) | UNIVERSITY OF PITTSBURGH—OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION |