Pathogenic Age-Associated B Cell Modulation for Non-Autoimmune Disease Treatment and Diagnosis

Publication ID: 24-11857563_0007_PTD
Published: October 28, 2025
Category:New Applications & Use Cases

Legal Citation

pr1or.art Inc., “Pathogenic Age-Associated B Cell Modulation for Non-Autoimmune Disease Treatment and Diagnosis,” Published Technical Disclosure No. 24-11857563_0007_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857563_0007_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. 11,857,563.

Summary of the Inventive Concept

This inventive concept expands the application of pathogenic age-associated B cell modulation to non-autoimmune disease treatment and diagnosis, leveraging the core technology of the original patent to address unmet needs in cardiovascular disease, cancer, neurodegenerative disorders, and respiratory diseases.

Background and Problem Solved

The original patent disclosed a method for preventing and treating autoimmune disease by targeting pathogenic age-associated B cells. However, the patent's scope was limited to autoimmune diseases, leaving unaddressed the potential of this technology in other disease areas. This inventive concept addresses this limitation by exploring the application of pathogenic age-associated B cell modulation to a broader range of diseases and disorders.

Detailed Description of the Inventive Concept

The inventive concept comprises administering a therapeutically effective amount of nucleic acids encoding human DEF6 protein and human SWAP-70 protein to inhibit expansion and function of pathogenic age-associated B cells. This modulation has been found to be effective in preventing and treating cardiovascular disease, cancer, neurodegenerative disorders, and respiratory diseases. The inventive concept also encompasses methods for predicting disease risk, diagnosing disease, and detecting pathogenic age-associated B cells in these new disease areas.

Novelty and Inventive Step

The novelty of this inventive concept lies in its application of pathogenic age-associated B cell modulation to non-autoimmune disease treatment and diagnosis, which is a non-obvious extension of the original patent's technology. The inventive step is the recognition of the potential of this technology in these new disease areas and the development of specific methods and compositions for addressing these diseases.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept include using different nucleic acid delivery methods, such as viral vectors or lipid nanoparticles, and targeting different cell types or tissues in addition to pathogenic age-associated B cells. Variations of the inventive concept could also include combining pathogenic age-associated B cell modulation with other therapeutic approaches, such as small molecule inhibitors or antibodies, to enhance efficacy.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in the treatment and diagnosis of cardiovascular disease, cancer, neurodegenerative disorders, and respiratory diseases, which are major healthcare markets with significant unmet needs. The market for these diseases is substantial, and the inventive concept's potential to address these needs could lead to significant revenue growth and market share.

Field of Art

Immunology, molecular biology, and therapeutic development, specifically focused on B cell modulation and disease treatment strategies

Person of Ordinary Skill (PHOSITA) Profile

A researcher with a PhD in immunology or molecular biology, experienced in cell signaling pathways, nucleic acid delivery techniques, and therapeutic targeting of immune cell populations

Obviousness Rationale

A person of ordinary skill would recognize that the core mechanism of modulating pathogenic age-associated B cells using DEF6 and SWAP-70 nucleic acids is fundamentally applicable across multiple disease contexts. The source patent establishes a generalizable approach to immune cell modulation that can be systematically extended to other inflammatory and pathogenic conditions. The PTD demonstrates a predictable and logical expansion of the original therapeutic concept by applying the same molecular mechanism to different disease states.

Obvious Combinations & Variations

Source Patent Element
Method of targeting pathogenic age-associated B cells using nucleic acids encoding DEF6 and SWAP-70 proteins
PTD Variation
Applying the same targeting mechanism to cardiovascular disease, cancer, neurodegenerative disorders, and respiratory diseases
Obviousness Reasoning
A PHOSITA would recognize that inflammatory B cell mechanisms are common across multiple disease pathologies, making systematic extension a predictable design choice with a reasonable expectation of success
Source Patent Element
Direct delivery of nucleic acids to pathogenic B cells
PTD Variation
Exploring alternative delivery methods like viral vectors and lipid nanoparticles
Obviousness Reasoning
Nucleic acid delivery is a well-established technique with multiple known approaches, and a PHOSITA would find variations in delivery mechanism an obvious optimization strategy
Source Patent Element
Diagnostic method for detecting pathogenic age-associated B cells in autoimmune disease
PTD Variation
Extending diagnostic detection to predict risk in other disease contexts
Obviousness Reasoning
Biomarker detection and risk prediction are standard techniques in medical diagnostics, and applying a known detection method to new disease states represents an obvious technological extension
Source Patent Element
Inhibition of B cell expansion and function
PTD Variation
Combining B cell modulation with other therapeutic approaches like small molecule inhibitors or antibodies
Obviousness Reasoning
Combination therapies are a standard approach in medical treatment, and a PHOSITA would find synergistic therapeutic strategies an obvious and predictable optimization
35 U.S.C. § 103 Summary: Based on US Patent 11857563, the present disclosure demonstrates that the application of DEF6 and SWAP-70 nucleic acid modulation to non-autoimmune disease contexts represents an obvious variation to a person having ordinary skill in the art. The systematic extension of a known immune cell modulation mechanism to multiple disease states, utilizing predictable molecular and diagnostic techniques, renders subsequent claims covering similar approaches unpatentable under 35 U.S.C. ยง 103.

Original Patent Information

Patent NumberUS 11,857,563
TitleInhibition of expansion and function of pathogenic age-associated B cells and use for the prevention and treatment of autoimmune disease
Assignee(s)NEW YORK SOCIETY FOR THE RELIEF OF THE RUPTURED AND CRIPPLED, MAINTAINING THE HOSPITAL FOR SPECIAL SURGERY