Next-Generation Synthetic pDNA Vaccines against SARS-CoV-2 Variants

Publication ID: 24-11857621_0010_PTD

Published: October 28, 2025

Category:Future Evolutions & Paradigm Shifts

Legal Citation

pr1or.art Inc., “Next-Generation Synthetic pDNA Vaccines against SARS-CoV-2 Variants,” Published Technical Disclosure No. 24-11857621_0010_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857621_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. 11,857,621.

Summary of the Inventive Concept

A novel, self-amplifying pDNA vaccine platform that induces protective humoral and cellular responses against multiple SARS-CoV-2 variants, enhancing vaccine efficacy and providing a robust defense against emerging strains.

Background and Problem Solved

The original patent disclosed a synthetic pDNA vaccine against COVID-19, but its limitations in addressing multiple variants and enhancing vaccine efficacy are overcome by the present inventive concept, which leverages self-amplifying RNA molecules and machine learning algorithms to optimize polynucleotide sequences.

Detailed Description of the Inventive Concept

The next-generation pDNA vaccine platform comprises a polynucleotide sequence at least 95% identical to SEQ ID NO: 1, self-amplifying RNA molecules, and optional microneedle-based delivery systems. Machine learning algorithms are used to identify optimal polynucleotide sequences, ensuring enhanced vaccine efficacy against multiple SARS-CoV-2 variants. The platform also includes wearable devices and cloud-based databases for monitoring and predicting vaccine efficacy.

Novelty and Inventive Step

The combination of self-amplifying RNA molecules, machine learning algorithms, and microneedle-based delivery systems in a single pDNA vaccine platform constitutes a novel and non-obvious improvement over the original patent, providing a paradigm shift in vaccine development against emerging infectious diseases.

Alternative Embodiments and Variations

Alternative embodiments may include using different machine learning algorithms, incorporating additional adjuvants or immunomodulators, or utilizing various delivery systems, such as nanoparticles or electroporation. Variations may also include targeting different infectious diseases or using the platform for cancer immunotherapy.

Potential Commercial Applications and Market

The next-generation pDNA vaccine platform has significant commercial potential in the global vaccine market, particularly in the context of emerging infectious diseases. Target industries include pharmaceutical companies, biotechnology firms, and government agencies focused on public health and pandemic preparedness.

CPC Classifications

Section	Class	Group
A	A61	A61K39/215
A	A61	A61K9/0019
A	A61	A61P31/14
C	C07	C07K14/005
A	A61	A61K2039/53
A	A61	A61K2039/54
A	A61	A61K2039/545
C	C12	C12N2770/20022
C	C12	C12N2770/20034
C	C12	C12N2770/20071

Section 103 Obviousness Analysis (PHOSITA)

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Field of Art

Molecular biology, vaccine design, and genetic engineering, with specialized expertise in DNA/RNA vaccine technologies, viral immunology, and bioinformatics

Person of Ordinary Skill (PHOSITA) Profile

A researcher with advanced degrees in molecular biology or bioengineering, experienced in vaccine development, sequence analysis, and computational biology techniques, familiar with emerging vaccine platforms and SARS-CoV-2 research

Obviousness Rationale

A PHOSITA would recognize that the PTD represents a predictable extension of the source patent's core vaccine technology by incorporating well-known techniques like self-amplifying RNA, machine learning sequence optimization, and advanced delivery systems. The variations represent incremental improvements using standard methodological approaches in vaccine design that would be apparent to a skilled practitioner seeking to enhance vaccine efficacy and adaptability.

Obvious Combinations & Variations

Source Patent Element

Plasmid DNA vaccine targeting SARS-CoV-2 spike protein sequences

PTD Variation

Adding self-amplifying RNA molecules to enhance vaccine efficacy and incorporating machine learning for sequence optimization

Obviousness Reasoning

Augmenting vaccine platforms with RNA amplification and computational design is a known technique for improving immunogenic response, representing a predictable optimization of existing vaccine technologies

Source Patent Element

DNA sequences related to SARS-CoV-2 receptor binding domains

PTD Variation

Utilizing polynucleotide sequences with 95% identity to source patent sequences and expanding variant coverage

Obviousness Reasoning

Sequence variation and optimization are standard approaches in vaccine design, with computational methods for identifying functionally equivalent genetic variants being well-established in the field

Source Patent Element

Basic plasmid DNA vaccine construct

PTD Variation

Integrating microneedle delivery systems and wearable monitoring technologies

Obviousness Reasoning

Advanced drug delivery methods and real-time monitoring are predictable technological improvements that a PHOSITA would consider as standard approaches to enhancing vaccine administration and tracking

Source Patent Element

Genetic sequence for SARS-CoV-2 spike protein

PTD Variation

Applying machine learning algorithms to identify optimal polynucleotide sequences across multiple viral variants

Obviousness Reasoning

Computational approaches for sequence optimization and variant prediction are standard bioinformatics techniques that would be obvious to implement in vaccine design

Source Patent Element

Basic vaccine development methodology

PTD Variation

Cloud-based database integration for tracking and predicting vaccine efficacy

Obviousness Reasoning

Digital health technologies and data-driven approaches are increasingly common in medical research, representing an obvious technological progression for vaccine development and monitoring

35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857621 and the disclosed technological variations, a person of ordinary skill in the art would find the claimed innovations obvious and lacking inventive step. The incremental modifications represent predictable applications of known techniques in vaccine design, sequence optimization, and delivery technologies, thereby rendering the claimed subject matter unpatentable under 35 U.S.C. § 103.

Original Patent Information

Patent Number	US 11,857,621
Title	Synthetic pDNA vaccines against COVID-19
Assignee(s)	Imam Abdulrahman Bin Faisal University