Enhanced Composition for Promoting FGF21 Secretion

Publication ID: 24-11857579_0001_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Composition for Promoting FGF21 Secretion,” Published Technical Disclosure No. 24-11857579_0001_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857579_0001_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. 11,857,579.

Summary of the Inventive Concept

This inventive concept discloses improved compositions and methods for promoting the secretion of fibroblast growth factor 21 (FGF21), addressing the limitations of the original patent by enhancing efficacy, reducing dosage, and providing real-time monitoring.

Background and Problem Solved

The original patent relates to a composition for promoting the secretion of FGF21, but it has inherent limitations, such as variable efficacy and potential high dosages. The present inventive concept solves these problems by introducing novel combinations of Bifidobacterium bacterium with prebiotics, probiotics, or nutrients, and by developing sustained-release formulations and real-time monitoring systems.

Detailed Description of the Inventive Concept

The inventive concept comprises four main aspects: (1) a system combining Bifidobacterium bacterium with a prebiotic to enhance growth and FGF21 secretion; (2) a method of enhancing efficacy by co-administering the composition with a probiotic; (3) a composition comprising Bifidobacterium bacterium and a nutrient to enhance FGF21 gene expression; and (4) a sustained-release formulation and real-time monitoring system to reduce dosage and optimize treatment. These innovations address the limitations of the original patent and provide more efficient and effective solutions.

Novelty and Inventive Step

The new claims introduce novel combinations of components and methods that are not obvious from the original patent. The use of prebiotics, probiotics, and nutrients to enhance FGF21 secretion, as well as the development of sustained-release formulations and real-time monitoring systems, constitutes a significant inventive step beyond the original patent.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include different types of prebiotics, probiotics, or nutrients, as well as varying formulations and delivery methods. Additionally, the inventive concept could be adapted for use in different applications, such as food products or pharmaceuticals.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in the fields of nutrition, pharmaceuticals, and healthcare, particularly in the development of treatments for metabolic disorders and other conditions related to FGF21 secretion.

Field of Art

Microbiome and Probiotic Biotechnology, specifically focused on bacterial compositions for metabolic and physiological modulation, requiring expertise in microbiology, nutritional science, and biotechnological formulation techniques

Person of Ordinary Skill (PHOSITA) Profile

A researcher or biotechnologist with advanced degree in microbiology or related field, familiar with probiotic strain characterization, metabolic pathway interactions, and formulation strategies for bacterial compositions

Obviousness Rationale

A person of ordinary skill would recognize that the PTD's variations represent predictable extensions of the source patent's core concept of using Bifidobacterium breve M-16V for physiological modulation. The proposed modifications involving prebiotics, nutrient enhancement, and monitoring systems represent standard optimization strategies within probiotic research. These variations would be considered routine experimental approaches for improving bacterial composition efficacy and delivery.

Obvious Combinations & Variations

Source Patent Element
Bifidobacterium breve M-16V bacterial composition for physiological modulation
PTD Variation
Adding prebiotic to enhance bacterial growth and FGF21 secretion
Obviousness Reasoning
Combining probiotics with prebiotics is a known technique for enhancing bacterial colonization and metabolic performance, representing a predictable optimization within microbiome engineering
Source Patent Element
Method of administering Bifidobacterium bacterium
PTD Variation
Sustained-release formulation to reduce dosage and prolong gut exposure
Obviousness Reasoning
Developing controlled-release delivery mechanisms is a standard pharmaceutical engineering approach for improving therapeutic agent performance, constituting an obvious design choice
Source Patent Element
Composition for promoting physiological secretion
PTD Variation
Real-time monitoring system using blood-based sensor for tracking FGF21 levels
Obviousness Reasoning
Implementing diagnostic monitoring for biological interventions is a well-established practice in personalized medicine, representing a logical extension of existing biotechnological approaches
Source Patent Element
Bacterial composition for metabolic modulation
PTD Variation
Co-administering with complementary probiotic to enhance colonization
Obviousness Reasoning
Combining multiple probiotic strains to improve therapeutic efficacy is a recognized strategy in microbiome research, representing a predictable optimization technique
Source Patent Element
Bifidobacterium breve M-16V administration method
PTD Variation
Incorporating nutrient to enhance FGF21 gene expression
Obviousness Reasoning
Nutritional modulation of gene expression is a well-understood mechanism in metabolic research, constituting a routine experimental approach for improving biological performance
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857579 and the disclosed variations, a person of ordinary skill in the art would find the proposed technical modifications obvious and predictable extensions of existing probiotic composition strategies. The incremental improvements in bacterial growth, delivery mechanisms, and monitoring techniques represent standard optimization approaches that do not rise to the level of non-obvious inventive activity, thus rendering potential claims in this domain anticipated and obvious.

Original Patent Information

Patent NumberUS 11,857,579
TitleComposition for promoting the secretion of FGF21
Assignee(s)Morinaga Milk Industry Co., Ltd.