Enhanced Vaccine Delivery Systems for Necrotic Enteritis Prevention in Poultry

Publication ID: 24-11857613_0006_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Vaccine Delivery Systems for Necrotic Enteritis Prevention in Poultry,” Published Technical Disclosure No. 24-11857613_0006_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857613_0006_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. 11,857,613.

Summary of the Inventive Concept

This inventive concept discloses improved vaccine delivery systems for protecting poultry against necrotic enteritis, enhancing immunogenicity, reducing production costs, and increasing large-scale manufacturing efficiency.

Background and Problem Solved

The original patent for a vaccine against necrotic enteritis in poultry has limitations in terms of delivery, immunogenicity, and production costs. The present inventive concept addresses these limitations by introducing novel oral delivery systems, booster doses, and large-scale production methods that improve the overall efficiency and effectiveness of the vaccine.

Detailed Description of the Inventive Concept

The inventive concept comprises four main aspects: 1) a system for oral delivery of a necrotic enteritis vaccine using a plant-based expression system, 2) a method for boosting immune response against necrotic enteritis by administering a booster dose with a toll-like receptor agonist, 3) a vaccine composition with a beta-glucan adjuvant to enhance the humoral immune response, and 4) a system for large-scale production of the vaccine using a plant-based expression system and membrane filtration. These aspects work together to provide a more efficient, cost-effective, and immunogenic vaccine against necrotic enteritis.

Novelty and Inventive Step

The new claims introduce novel oral delivery systems, booster doses, and large-scale production methods that are not obvious from the original patent. The use of plant-based expression systems, toll-like receptor agonists, and beta-glucan adjuvants, as well as the specific combinations and formulations disclosed, provide a non-obvious solution to the limitations of the original patent.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include different plant-based expression systems, various mucosal adjuvants, or alternative downstream processing methods. Variations could also include different formulations of the vaccine composition or different schedules for administering the booster dose.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in the poultry industry, where necrotic enteritis is a major concern. The improved vaccine delivery systems and production methods could lead to increased adoption and reduced costs, making the vaccine more accessible to poultry farmers worldwide.

CPC Classifications

SectionClassGroup
A A61 A61K39/08
A A61 A61P31/04
C C12 C12N15/74
C C12 C12N15/8258
A A61 A61K2039/552
A A61 A61K2039/55577

Field of Art

Veterinary biotechnology, specifically vaccine development for poultry diseases, with expertise in protein engineering, immunology, and microbial pathogen prevention

Person of Ordinary Skill (PHOSITA) Profile

A researcher with advanced degrees in veterinary science or microbiology, experienced in protein fusion techniques, vaccine design, and understanding of bacterial pathogen mechanisms, familiar with recombinant protein expression and immunological strategies

Obviousness Rationale

A person skilled in the art would recognize that the PTD's variations represent predictable extensions of the source patent's core vaccine technology. The fundamental concept of a PlcC-NetB fusion protein remains consistent, with the PTD merely introducing standard biotechnological optimization strategies such as alternative expression systems and adjuvant formulations. These modifications represent routine engineering approaches well-established in vaccine development methodologies.

Obvious Combinations & Variations

Source Patent Element
PlcC-NetB fusion protein for C. perfringens prevention
PTD Variation
Plant-based expression system for producing the fusion protein
Obviousness Reasoning
Plant-based protein expression is a known alternative to bacterial or mammalian systems, offering cost-effective and scalable production. A PHOSITA would recognize this as a predictable variation in recombinant protein manufacturing
Source Patent Element
Vaccine targeting C. perfringens in poultry
PTD Variation
Incorporation of toll-like receptor agonist in booster dose
Obviousness Reasoning
Immunological adjuvants are standard techniques for enhancing vaccine efficacy. A PHOSITA would understand that modifying immune response through receptor agonists represents a conventional approach in vaccine design
Source Patent Element
Protein-based vaccine composition
PTD Variation
Beta-glucan adjuvant to enhance humoral immune response
Obviousness Reasoning
Adjuvant selection is a routine optimization strategy in vaccine development. Beta-glucans are well-known immunomodulators, and their application would be an obvious approach for improving vaccine performance
Source Patent Element
Protein fusion vaccine targeting specific bacterial proteins
PTD Variation
Membrane filtration for large-scale protein purification
Obviousness Reasoning
Downstream processing techniques like membrane filtration are standard in biotechnological manufacturing. A PHOSITA would recognize this as a predictable method for improving vaccine production efficiency
Source Patent Element
Recombinant protein vaccine production
PTD Variation
Reduced growth temperature plant expression system
Obviousness Reasoning
Energy-efficient protein production is a known optimization strategy. Modifying expression conditions to reduce costs represents a standard engineering approach in biotechnology
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857613 and the disclosed variations, a person having ordinary skill in the art would find the claimed vaccine delivery and production methods obvious. The PTD demonstrates that the proposed modifications represent predictable variations within the established technological framework of bacterial protein-based vaccines, thereby rendering subsequent claims of novelty non-patentable under 35 U.S.C. Section 103.

Original Patent Information

Patent NumberUS 11,857,613
TitleVaccine for prevention of necrotic enteritis in poultry
Assignee(s)Arizona Board of Regents on Behalf of Arizona State University