Enhanced Compositions and Methods for Treating Congenital Diarrhea Disorder

Publication ID: 24-11857510_0006_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Compositions and Methods for Treating Congenital Diarrhea Disorder,” Published Technical Disclosure No. 24-11857510_0006_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857510_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. 11,857,510.

Summary of the Inventive Concept

This inventive concept improves upon the original patent by providing enhanced compositions and methods for treating congenital diarrhea disorder, offering better efficacy, convenience, and patient outcomes.

Background and Problem Solved

The original patent disclosed methods and compositions for treating congenital diarrhea disorder using proanthocyanidin polymer compositions. However, the original patent's limitations included the need for frequent administration, potential side effects, and limited bioavailability. This inventive concept addresses these limitations by introducing controlled release formulations, sustained release formulations, nanoparticle formulations, and combination therapies to provide more efficient, safer, and effective treatment options.

Detailed Description of the Inventive Concept

The new inventive concept comprises four key aspects: (1) controlled release formulations to reduce the frequency of administration, (2) sustained release formulations to provide a therapeutic effect over a prolonged period, (3) nanoparticle formulations to increase the bioavailability of the proanthocyanidin polymer, and (4) combination therapies with anti-inflammatory agents, anti-infective agents, or prebiotics to enhance treatment outcomes. These enhancements enable more efficient and effective treatment of congenital diarrhea disorder, improving patient quality of life.

Novelty and Inventive Step

The new inventive concept's controlled release, sustained release, and nanoparticle formulations, as well as the combination therapies, are novel and non-obvious improvements over the original patent, providing a significant inventive step in the field of congenital diarrhea disorder treatment.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include other types of formulations, such as liposomal or microemulsion formulations, or different combinations of therapeutic agents. Variations of the inventive concept could also include different routes of administration, such as oral, parenteral, or rectal administration.

Potential Commercial Applications and Market

The enhanced compositions and methods for treating congenital diarrhea disorder have significant commercial potential in the pharmaceutical industry, particularly in the pediatric and gastroenterology markets. The inventive concept's improved efficacy, convenience, and patient outcomes could lead to increased market share and revenue growth for companies operating in these markets.

CPC Classifications

SectionClassGroup
A A61 A61K31/353
A A61 A61K9/0095
A A61 A61K9/28
A A61 A61K9/48
A A61 A61P1/04
A A61 A61P1/12

Field of Art

Pharmaceutical compositions and methods for treating gastrointestinal disorders, specifically congenital diarrheal disorders, with expertise in drug delivery systems, formulation technologies, and pediatric therapeutic interventions

Person of Ordinary Skill (PHOSITA) Profile

A pharmaceutical scientist or clinical researcher with advanced degrees in pharmacy, pharmacology, or biomedical engineering, possessing knowledge of drug delivery technologies, polymer chemistry, and pediatric therapeutic strategies

Obviousness Rationale

A PHOSITA would recognize that the disclosed variations represent predictable extensions of the source patent's core invention, utilizing standard pharmaceutical formulation techniques to improve drug delivery and therapeutic efficacy. The controlled release, sustained release, and nanoparticle formulations represent well-known strategies for enhancing drug performance that would be immediately apparent to a skilled practitioner in the field of pharmaceutical compositions. The combination therapy approach is a standard method for improving treatment outcomes in complex medical conditions.

Obvious Combinations & Variations

Source Patent Element
Method of treating secretory diarrhea using proanthocyanidin polymer in infants
PTD Variation
Controlled release formulation to reduce administration frequency
Obviousness Reasoning
Controlled release technologies are a known technique in pharmaceutical science for improving patient compliance and drug efficacy, representing a predictable optimization of the original treatment method
Source Patent Element
Composition for treating congenital diarrheal disorder
PTD Variation
Nanoparticle formulation to increase bioavailability
Obviousness Reasoning
Nanoparticle drug delivery is a well-established approach for improving drug absorption and distribution, which would be an obvious enhancement to a skilled practitioner seeking to optimize therapeutic performance
Source Patent Element
Treatment method for secretory diarrhea in infants
PTD Variation
Combination therapy with anti-inflammatory or anti-infective agents
Obviousness Reasoning
Combination therapies are a standard medical approach for addressing complex disorders, particularly in pediatric patients, representing a logical and predictable extension of the original treatment strategy
Source Patent Element
Proanthocyanidin polymer composition for diarrhea treatment
PTD Variation
Sustained release formulation for prolonged therapeutic effect
Obviousness Reasoning
Sustained release technologies are a routine pharmaceutical technique for extending drug action, which would be an obvious modification to improve patient treatment outcomes
Source Patent Element
Method of administering proanthocyanidin polymer to infants
PTD Variation
Alternative administration routes including oral, parenteral, and rectal
Obviousness Reasoning
Exploring multiple administration routes is a standard practice in pharmaceutical development, representing a predictable variation that would be obvious to a skilled practitioner seeking to optimize drug delivery
35 U.S.C. § 103 Summary: Pursuant to 35 U.S.C. ยง 103, the variations disclosed in this publication would be considered obvious to a person having ordinary skill in the art at the time of the invention, when viewed in light of US Patent 11857510. The disclosed formulation and combination strategies represent predictable extensions of the source patent's core invention, utilizing standard pharmaceutical techniques to enhance drug delivery and therapeutic efficacy in treating congenital diarrheal disorders.

Original Patent Information

Patent NumberUS 11,857,510
TitleMethods and compositions for treating congenital diarrhea disorder
Assignee(s)NAPO PHARMACEUTICALS, INC.