Enhanced Collagenase-Based System for Uterine Fibroid Treatment

Publication ID: 24-11857685_0001_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Collagenase-Based System for Uterine Fibroid Treatment,” Published Technical Disclosure No. 24-11857685_0001_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857685_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. 11,857,685.

Summary of the Inventive Concept

A novel system and method for treating uterine fibroids, leveraging pH-adjusted buffers, temperature-controlled needles, protease inhibitors, and fibronectin-binding peptides to enhance collagenase efficacy and minimize off-target effects.

Background and Problem Solved

The original patent disclosed a method for treating uterine fibroids using purified collagenase. However, the existing approach has limitations, including suboptimal collagenase activity, inadequate tissue penetration, and potential off-target effects. The new inventive concept addresses these limitations by introducing pH-adjusted buffers, temperature-controlled needles, protease inhibitors, and fibronectin-binding peptides to enhance collagenase efficacy and minimize off-target effects.

Detailed Description of the Inventive Concept

The enhanced system comprises a collagenase composition with a pH-adjusted buffer to optimize enzymatic activity. The composition is delivered through a temperature-controlled needle to facilitate efficient tissue penetration. Additionally, a protease inhibitor is included to minimize off-target effects. In some embodiments, a fibronectin-binding peptide is added to enhance collagen degradation. The system also includes a biocompatible carrier for sustained release of the collagenase composition. A device for delivering the composition features a catheter with a porous membrane to facilitate localized delivery, and a pressure sensor to monitor injection force. Furthermore, a method for predicting treatment outcomes involves analyzing gene expression profiles of fibroid tissue to identify markers of collagenase responsiveness, and using machine learning algorithms to predict treatment efficacy.

Novelty and Inventive Step

The new claims introduce several novel and non-obvious features, including pH-adjusted buffers, temperature-controlled needles, protease inhibitors, and fibronectin-binding peptides, which collectively enhance collagenase efficacy and minimize off-target effects. These features are not anticipated by the original patent and represent a significant improvement over the existing approach.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept include using different pH-adjusted buffers, temperature-controlled needle designs, and protease inhibitors. Additionally, the fibronectin-binding peptide could be replaced with other collagen-binding peptides or molecules. The device for delivering the composition could also be modified to include different types of catheters, needles, or sensors.

Potential Commercial Applications and Market

The enhanced collagenase-based system has significant commercial potential in the medical device and pharmaceutical industries, particularly in the treatment of uterine fibroids. The target market includes hospitals, clinics, and medical centers specializing in women's health and reproductive medicine.

CPC Classifications

SectionClassGroup
A A61 A61K9/48
A A61 A61K9/0019
A A61 A61K9/0034
A A61 A61K9/1075
A A61 A61K38/43
A A61 A61K38/4886
A A61 A61K45/06
C C12 C12Y304/24003

Field of Art

Medical biotechnology focused on enzymatic tissue modification, specifically uterine fibroid treatment using collagenase-based interventions. Requires expertise in molecular biology, medical device design, enzyme engineering, and minimally invasive medical procedures

Person of Ordinary Skill (PHOSITA) Profile

A biomedical engineer or medical researcher with advanced degrees in biotechnology, experience in enzyme modification techniques, understanding of collagen degradation mechanisms, and familiarity with minimally invasive medical interventions

Obviousness Rationale

A person having ordinary skill would recognize that the PTD's variations represent predictable engineering improvements to the source patent's collagenase treatment method. The disclosed enhancements like pH-adjusted buffers, temperature-controlled delivery, and protease inhibitors are logical extensions of known techniques for optimizing enzymatic interventions. These modifications represent standard problem-solving approaches in biomedical engineering that would be apparent to a skilled practitioner seeking to improve tissue-specific enzymatic treatments.

Obvious Combinations & Variations

Source Patent Element
Collagenase composition delivered through needle/catheter for uterine fibroid treatment
PTD Variation
Temperature-controlled needle with porous membrane and pressure sensor for enhanced delivery precision
Obviousness Reasoning
Predictable design optimization using known medical device engineering techniques to improve injection accuracy and tissue penetration
Source Patent Element
Collagenase from Clostridium histolyticum at specific concentrations
PTD Variation
Adding pH-adjusted buffer and protease inhibitors to modulate enzymatic activity
Obviousness Reasoning
Known technique for enzyme performance optimization using standard biochemical manipulation strategies
Source Patent Element
Localized collagenase administration into uterine fibroids
PTD Variation
Incorporating fibronectin-binding peptides to enhance collagen degradation specificity
Obviousness Reasoning
Finite set of predictable molecular engineering approaches to improve enzymatic targeting and reduce off-target effects
Source Patent Element
Medical intervention for uterine fibroid treatment
PTD Variation
Machine learning algorithm for predicting treatment outcomes based on gene expression profiles
Obviousness Reasoning
Applying standard computational biology techniques to personalize and optimize medical interventions
35 U.S.C. § 103 Summary: Based on comprehensive analysis of US Patent 11857685 and the corresponding Published Technical Disclosure, a person having ordinary skill in the art would find the claimed variations obvious and lacking inventive step under 35 U.S.C. ยง 103. The disclosed modifications represent predictable engineering improvements utilizing known biotechnological techniques, thereby rendering subsequent claims obvious and anticipatable by the prior art.

Original Patent Information

Patent NumberUS 11,857,685
TitleTreatment method and product for uterine fibroids using purified collagenase
Assignee(s)Duke University, BioSpecifics Technologies LLC