Advanced RNA-Based Immunisation System with Personalised and Sustained Release Capabilities

Publication ID: 24-11857681_0010_PTD
Published: October 28, 2025
Category:Future Evolutions & Paradigm Shifts

Legal Citation

pr1or.art Inc., “Advanced RNA-Based Immunisation System with Personalised and Sustained Release Capabilities,” Published Technical Disclosure No. 24-11857681_0010_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857681_0010_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. 11,857,681.

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

SectionClassGroup
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

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

Source Patent Element
Lipid particles containing RNA molecules encoding immunogens
PTD Variation
Nanoparticle-based delivery vehicle with polymeric matrix for sustained release
Obviousness Reasoning
Sustained release formulations are a known technique in drug delivery, and a PHOSITA would find it obvious to modify lipid particle compositions to enhance immunogen exposure and immune response
Source Patent Element
RNA molecules with specific cap structures and 2'-methylated ribose
PTD Variation
RNA encoding multiple immunogens including coronavirus, EBV, and CMV
Obviousness Reasoning
Expanding immunogen encoding to multiple targets is a predictable approach in vaccine development, representing a routine design choice for broadening immune protection
Source Patent Element
PEG-conjugated lipids in lipid particle composition
PTD Variation
Personalized RNA library with selectable immunogen-encoding molecules
Obviousness Reasoning
Customizable vaccine approaches are a natural progression in precision medicine, utilizing known lipid nanoparticle technologies to enable targeted immunisation strategies
Source Patent Element
Lipid-based RNA delivery for immunisation
PTD Variation
Addition of Toll-like receptor agonists to enhance immune response
Obviousness Reasoning
Immunological adjuvant techniques are well-established, and incorporating receptor agonists represents a standard method for modulating immune system activation
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857681 and the disclosed technical variations, a person of ordinary skill in the art would find the claimed RNA delivery system and immunisation methods obvious and anticipated, rendering potential patent claims in this domain obvious and unpatentable as a matter of law.

Original Patent Information

Patent NumberUS 11,857,681
TitleLipid formulations with RNA encoding immunogens
Assignee(s)GlaxoSmith Kline Biologicals S.A.