Advanced RNA-Based Immunisation System with Personalised and Sustained Release Capabilities
Legal Citation
Summary of the Inventive Concept
A next-generation RNA-based immunisation system featuring nanoparticle-based delivery, lipid-based adjuvants, and polymeric matrices for sustained release, enabling personalised and targeted immune responses against multiple immunogens.
Background and Problem Solved
The original patent, 'Lipid formulations with RNA encoding immunogens', demonstrated the potential of RNA-based immunisation. However, the delivery and release of RNA molecules remain significant challenges. The present inventive concept addresses these limitations by introducing advanced nanoparticle-based delivery vehicles, lipid-based adjuvants, and polymeric matrices for sustained release, thereby enhancing the efficacy and versatility of RNA-based immunisation.
Detailed Description of the Inventive Concept
The inventive concept comprises a system for in vivo RNA-based immunisation, featuring a nanoparticle-based delivery vehicle encapsulating RNA encoding multiple immunogens. The RNA is formulated with a lipid-based adjuvant and a polymeric matrix for sustained release. This enables targeted and prolonged exposure of the immune system to the immunogens, inducing a humoural immune response. The system can be personalised by selecting specific RNA molecules from a library, allowing for tailored immune responses. The nanoparticle-based delivery vehicle can be further optimised by varying the composition of the lipid-based adjuvant and polymeric matrix.
Novelty and Inventive Step
The present inventive concept introduces a paradigm shift in RNA-based immunisation by combining advanced nanoparticle-based delivery vehicles, lipid-based adjuvants, and polymeric matrices for sustained release. This integration enables personalised and targeted immune responses, which is not achievable with the original patent's lipid formulations. The inventive concept's novelty lies in the synergistic combination of these components, which provides a significant improvement over existing RNA-based immunisation approaches.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept may include varying the composition of the lipid-based adjuvant, using different types of polymeric matrices, or incorporating additional immunostimulatory molecules. The system could also be adapted for mucosal or transdermal delivery, or for use in veterinary applications.
Potential Commercial Applications and Market
The advanced RNA-based immunisation system has significant commercial potential in the vaccine market, particularly for infectious diseases such as COVID-19, EBV, and CMV. The system's personalised and sustained release capabilities also make it an attractive solution for cancer immunotherapy and autoimmune disease treatment.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K9/127 |
| A | A61 | A61K9/1272 |
| A | A61 | A61K31/7088 |
| A | A61 | A61K39/00 |
| A | A61 | A61K39/12 |
| C | C12 | C12N15/86 |
| A | A61 | A61K39/39 |
| A | A61 | A61K2039/53 |
| A | A61 | A61K2039/55555 |
| C | C12 | C12N2710/16134 |
| C | C12 | C12N2760/18534 |
| C | C12 | C12N2770/36134 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Biotechnology and pharmaceutical sciences, specifically RNA-based vaccine delivery systems, focusing on non-viral lipid nanoparticle formulations for immunogen encoding and targeted immune response generation
Person of Ordinary Skill (PHOSITA) Profile
A skilled practitioner with advanced degrees in biotechnology, molecular biology, or pharmaceutical sciences, possessing expertise in RNA delivery technologies, lipid nanoparticle formulation, immunology, and vaccine development techniques
Obviousness Rationale
A PHOSITA would recognize that the PTD's disclosed variations represent predictable extensions of the source patent's RNA delivery technology by integrating known techniques in nanoparticle design, sustained release matrices, and multi-immunogen encoding strategies. The proposed modifications leverage standard approaches in vaccine development and represent incremental improvements that would be apparent to a skilled researcher working in RNA immunisation technologies.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,681 |
|---|---|
| Title | Lipid formulations with RNA encoding immunogens |
| Assignee(s) | GlaxoSmith Kline Biologicals S.A. |