Enhanced Systems and Methods for Treating Inflammatory Bowel Disease through Peripheral Nerve Stimulation

Publication ID: 24-11857778_0001_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Systems and Methods for Treating Inflammatory Bowel Disease through Peripheral Nerve Stimulation,” Published Technical Disclosure No. 24-11857778_0001_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857778_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. 11,857,778.

Summary of the Inventive Concept

The inventive concept enhances the original peripheral nerve stimulation system for treating inflammatory bowel disease by introducing tailored electrical nerve stimulation signals, real-time monitoring, and personalized therapy, leading to improved treatment outcomes and enhanced patient safety.

Background and Problem Solved

The original patent disclosed a method for treating inflammatory bowel disease through peripheral nerve stimulation, but it had limitations in terms of signal customization, real-time feedback, and patient-specific optimization. The new inventive concept addresses these limitations by incorporating advanced signal processing, monitoring capabilities, and personalized therapy, thereby improving treatment efficacy and reducing potential side effects.

Detailed Description of the Inventive Concept

The inventive concept comprises a stimulation device configured to deliver tailored electrical nerve stimulation signals to specific peripheral nerves, modulating both parasympathetic and sympathetic nervous systems to activate an anti-inflammatory pathway. The system includes real-time monitoring capabilities to adjust the electrical stimulation parameter based on the patient's inflammatory response. Additionally, the system can be personalized by determining a patient's specific nerve conduction velocity and adjusting the electrical stimulation parameter accordingly. The inventive concept also encompasses simultaneous stimulation of multiple peripheral nerves to enhance the anti-inflammatory effect.

Novelty and Inventive Step

The new claims introduce novel elements such as tailored electrical nerve stimulation signals, real-time monitoring, and personalized therapy, which are not present in the original patent. These advancements provide a non-obvious improvement over the prior art, enabling more effective and safe treatment of inflammatory bowel disease.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include varying the signal frequency, pulse width, or amplitude to optimize the anti-inflammatory effect. Additionally, the system could be adapted for use with other inflammatory diseases or conditions, such as rheumatoid arthritis or autoimmune hepatitis.

Potential Commercial Applications and Market

The enhanced peripheral nerve stimulation system has significant commercial potential in the treatment of inflammatory bowel disease, with a growing market demand for non-pharmacological and minimally invasive therapies. The system could be marketed to gastroenterologists, pain management specialists, and other healthcare professionals, with potential applications in hospitals, clinics, and private practices.

Field of Art

Biomedical engineering focused on neuromodulation techniques for treating inflammatory conditions, specifically gastrointestinal disorders. Requires expertise in electrical stimulation, neurophysiology, and medical device design

Person of Ordinary Skill (PHOSITA) Profile

A biomedical engineer or medical device researcher with advanced degrees in bioengineering, electrical engineering, or medical electronics, possessing knowledge of nerve stimulation parameters, inflammatory response mechanisms, and signal modulation techniques

Obviousness Rationale

A person having ordinary skill would recognize that the PTD's variations represent predictable extensions of the source patent's core peripheral nerve stimulation methodology. The disclosed enhancements like real-time monitoring, multi-nerve stimulation, and personalized signal adjustment are logical progressions of the original nerve stimulation approach. These modifications represent standard engineering design iterations that would be apparent to a skilled practitioner seeking to optimize inflammatory disease treatment.

Obvious Combinations & Variations

Source Patent Element
Transcutaneous peripheral nerve stimulation for inflammatory gastrointestinal disease treatment
PTD Variation
Adding real-time inflammatory response monitoring to adjust stimulation parameters
Obviousness Reasoning
Adaptive control techniques are well-known in medical device design, and monitoring patient response represents a predictable optimization strategy for nerve stimulation therapies
Source Patent Element
Electrical stimulation of specific nerve fiber types (A-alpha, A-beta, etc.)
PTD Variation
Simultaneous stimulation of multiple peripheral nerves to enhance anti-inflammatory effect
Obviousness Reasoning
Expanding nerve stimulation coverage is an obvious design choice for improving therapeutic outcomes, utilizing known neurophysiological principles
Source Patent Element
Adjusting electrical stimulation parameters like pulse width and duration
PTD Variation
Personalizing stimulation based on individual patient's nerve conduction velocity
Obviousness Reasoning
Tailoring medical device parameters to patient-specific physiological characteristics represents a standard approach in precision medical interventions
Source Patent Element
Nerve stimulation for inflammatory gastrointestinal disease treatment
PTD Variation
Modulating both parasympathetic and sympathetic nervous systems to activate anti-inflammatory pathways
Obviousness Reasoning
Expanding neurological targeting to include multiple nervous system components is an obvious refinement for improving therapeutic efficacy
Source Patent Element
Fixed electrical nerve stimulation signals
PTD Variation
Dynamic signal frequency modulation to optimize anti-inflammatory effect
Obviousness Reasoning
Adjusting signal characteristics to improve therapeutic outcomes represents a predictable engineering optimization technique
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857778, the disclosed peripheral nerve stimulation variations represent obvious extensions of the prior art, demonstrating that a person having ordinary skill in the art would find the claimed innovations predictable and non-inventive. The systematic enhancements in monitoring, personalization, and multi-nerve stimulation strategies constitute routine engineering design choices that would be apparent to a skilled practitioner seeking to improve inflammatory disease treatment methodologies.

Original Patent Information

Patent NumberUS 11,857,778
TitleSystems and methods for treating inflammatory bowel disease through peripheral nerve stimulation
Assignee(s)Cala Health, Inc.