Peripheral Nerve Stimulation for Diverse Therapeutic Applications

Publication ID: 24-11857778_0002_PTD

Published: October 28, 2025

Category:New Applications & Use Cases

Legal Citation

pr1or.art Inc., “Peripheral Nerve Stimulation for Diverse Therapeutic Applications,” Published Technical Disclosure No. 24-11857778_0002_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857778_0002_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

This inventive concept expands the core technology of peripheral nerve stimulation to address various unmet medical needs in new industries, including chronic pain management, cognitive function enhancement, anxiety disorder treatment, sleep quality improvement, and motor function restoration.

Background and Problem Solved

The original patent focused on treating inflammatory bowel disease through peripheral nerve stimulation. However, this technology has broader potential applications. The new inventive concept addresses the limitations of the original patent by exploring alternative uses for peripheral nerve stimulation, thereby providing new therapeutic solutions for diverse medical conditions.

Detailed Description of the Inventive Concept

The inventive concept involves applying the core technology of peripheral nerve stimulation to new therapeutic areas. This is achieved by modulating autonomic tone, parasympathetic tone, or sympathetic tone through transcutaneous stimulation of specific peripheral nerves. For instance, stimulating the residual limb can treat chronic pain in amputees, while stimulating the vagus nerve can enhance cognitive function in individuals with traumatic brain injury. Similarly, stimulating the saphenous nerve can treat anxiety disorders in individuals with autism spectrum disorder, stimulating the median nerve can improve sleep quality in individuals with insomnia, and stimulating the tibial nerve can enhance motor function in individuals with spinal cord injury.

Novelty and Inventive Step

The new claims introduce novel applications of peripheral nerve stimulation, expanding its therapeutic scope beyond inflammatory bowel disease. The inventive step lies in identifying specific peripheral nerves and stimulation parameters that can effectively address diverse medical conditions, thereby providing new and non-obvious solutions.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept may include varying the type of peripheral nerve stimulated, the stimulation parameters, or the specific medical condition being targeted. Additionally, the inventive concept could be adapted for use in other industries, such as sports medicine or cosmetic treatments, to enhance performance or appearance.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in various industries, including pain management, neurology, psychiatry, and rehabilitation. The target markets include pharmaceutical companies, medical device manufacturers, and healthcare providers seeking innovative solutions for unmet medical needs.

Section 103 Obviousness Analysis (PHOSITA)

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Field of Art

Biomedical engineering, specifically peripheral nerve stimulation for therapeutic interventions, with expertise in neurophysiology, electrical stimulation techniques, and medical device design

Person of Ordinary Skill (PHOSITA) Profile

A biomedical engineer or neurophysiologist with advanced degree, understanding of nerve fiber types, electrical stimulation parameters, and therapeutic neuromodulation techniques across different physiological systems

Obviousness Rationale

A PHOSITA would recognize that the core principles of peripheral nerve stimulation disclosed in the source patent can be systematically extended to other therapeutic applications by applying known neuromodulation techniques. The fundamental approach of transcutaneous nerve stimulation to modulate autonomic nervous system responses is consistent across different medical conditions. The variations in the PTD represent predictable applications of established nerve stimulation principles, utilizing similar electrical stimulation parameters and nerve targeting strategies.

Obvious Combinations & Variations

Source Patent Element

Transcutaneous electrical stimulation of peripheral nerves to treat inflammatory gastrointestinal diseases

PTD Variation

Applying similar transcutaneous stimulation techniques to treat chronic pain in amputees by stimulating residual limb nerves

Obviousness Reasoning

Known technique of nerve modulation applied to a predictable alternative therapeutic context with similar physiological targeting mechanism

Source Patent Element

Electrical stimulation targeting specific nerve fiber types (A-alpha, A-beta, A-delta, A-gamma, B fibers)

PTD Variation

Selecting specific peripheral nerves (vagus, saphenous, median, tibial) for targeted neuromodulation in different medical conditions

Obviousness Reasoning

Predictable extension of nerve fiber selection principles to alternative therapeutic applications with finite, identifiable nerve targets

Source Patent Element

Adjusting electrical stimulation parameters like pulse width within 5-10% of nerve fiber chronaxie

PTD Variation

Modulating stimulation parameters to achieve specific autonomic, parasympathetic, or sympathetic tone modifications

Obviousness Reasoning

Known electrical stimulation parameter optimization technique applied to achieve consistent neuromodulatory effects across different physiological systems

Source Patent Element

Positioning peripheral nerve effectors transcutaneously to stimulate specific nerve pathways

PTD Variation

Positioning nerve stimulation devices on skin to target nerves for cognitive enhancement, anxiety reduction, and motor function restoration

Obviousness Reasoning

Straightforward application of established transcutaneous nerve stimulation methodology to expand therapeutic intervention strategies

35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857778 regarding peripheral nerve stimulation for inflammatory conditions, a person of ordinary skill in the art would find the disclosed variations in therapeutic applications obvious and predictable extensions of the fundamental neuromodulation techniques. The systematic application of transcutaneous electrical nerve stimulation to diverse medical conditions represents an obvious combination of known techniques with expected results, thereby rendering potential patent claims in these areas unpatentable under 35 U.S.C. § 103.

Original Patent Information

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