Personalized Ototoxicity Prevention and Mitigation System

Publication ID: 24-11857567_0010_PTD
Published: October 28, 2025
Category:Future Evolutions & Paradigm Shifts

Legal Citation

pr1or.art Inc., “Personalized Ototoxicity Prevention and Mitigation System,” Published Technical Disclosure No. 24-11857567_0010_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857567_0010_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. 11,857,567.

Summary of the Inventive Concept

The present invention provides a next-generation system for mitigating ototoxicity associated with platinum-based antineoplastic agents, comprising adaptive, real-time dosing of anti-platinum chemoprotectant agents, personalized to individual subjects' genetic profiles and audiometric responses.

Background and Problem Solved

Platinum-based antineoplastic agents, such as cisplatin, are widely used to treat cancers and tumors, but they are known to induce hearing loss in human and animal models. The original patent disclosed hypertonic pharmaceutical compositions containing an anti-platinum chemoprotectant agent to mitigate ototoxicity. However, these compositions have limitations, including fixed dosing regimens and lack of personalization. The present inventive concept addresses these limitations by introducing a system that dynamically adjusts the dosage of anti-platinum chemoprotectant agents based on individual subjects' responses, providing a more effective and personalized approach to ototoxicity prevention and mitigation.

Detailed Description of the Inventive Concept

The system comprises a platinum-based antineoplastic agent delivery module and an adaptive, real-time anti-platinum chemoprotectant agent dosing module. The dosing module uses machine learning algorithms to analyze the subject's genetic profile, medical history, and audiometric response to platinum-based antineoplastic agents. Based on this analysis, the module selects an optimal anti-platinum chemoprotectant agent and dosage regimen, which is then administered to the subject. The system may also include a wearable device for monitoring ototoxicity, a computer-implemented method for predicting ototoxicity risk, and a nanoparticle-based delivery system for targeted and sustained release of the anti-platinum chemoprotectant agent.

Novelty and Inventive Step

The present inventive concept introduces a paradigm shift in ototoxicity prevention and mitigation by providing a personalized, adaptive, and real-time approach. The use of machine learning algorithms to analyze individual subjects' responses and adjust dosing regimens is a novel and non-obvious aspect of the invention. Additionally, the integration of wearable devices, computer-implemented methods, and nanoparticle-based delivery systems provides a comprehensive and innovative solution to ototoxicity prevention and mitigation.

Alternative Embodiments and Variations

Alternative embodiments of the system may include the use of different machine learning algorithms, additional sensors for monitoring ototoxicity, or different types of nanoparticle-based delivery systems. Variations of the system may include the use of different anti-platinum chemoprotectant agents, different dosing regimens, or different methods for predicting ototoxicity risk.

Potential Commercial Applications and Market

The present inventive concept has significant commercial potential in the pharmaceutical and healthcare industries, particularly in the areas of oncology and otolaryngology. The system may be marketed as a comprehensive solution for ototoxicity prevention and mitigation, providing a competitive advantage over existing products and treatments. Potential customers may include pharmaceutical companies, hospitals, and clinics, as well as individual patients and healthcare providers.

Field of Art

Pharmaceutical composition design, medical device technology, and personalized medicine with a focus on chemotherapy-related ototoxicity prevention and treatment

Person of Ordinary Skill (PHOSITA) Profile

A person with advanced training in pharmaceutical sciences, biomedical engineering, or clinical pharmacology, possessing expertise in drug delivery systems, machine learning applications in medical technology, and knowledge of platinum-based chemotherapy side effects

Obviousness Rationale

A PHOSITA would recognize that the personalized ototoxicity prevention system represents an incremental and predictable advancement of the source patent's pharmaceutical composition technology. The integration of machine learning, genetic profiling, and adaptive dosing represents a logical extension of existing chemoprotectant agent research. The core technical problem of mitigating platinum-based chemotherapy side effects remains consistent between the source patent and the published technical disclosure.

Obvious Combinations & Variations

Source Patent Element
Hypertonic pharmaceutical composition with anti-platinum chemoprotectant agents
PTD Variation
Nanoparticle-based delivery system targeting cochlea with sustained release mechanism
Obviousness Reasoning
A PHOSITA would find it obvious to modify drug delivery mechanisms to improve targeted administration, as nanoparticle technologies are well-established in pharmaceutical engineering for enhancing drug efficacy and reducing systemic side effects
Source Patent Element
Anti-platinum chemoprotectant agents like sodium thiosulfate
PTD Variation
Machine learning algorithm for selecting optimal chemoprotectant agent based on genetic profile
Obviousness Reasoning
Personalized medicine approaches using genetic profiling to optimize drug selection are a known technique in contemporary pharmaceutical research, representing a predictable application of computational methods to existing pharmaceutical compositions
Source Patent Element
Pharmaceutical compositions for mitigating chemotherapy side effects
PTD Variation
Wearable device for real-time ototoxicity monitoring with audiometric response tracking
Obviousness Reasoning
Integrating monitoring technologies with pharmaceutical interventions is a standard design approach in medical device development, representing an obvious combination of known techniques to improve patient outcomes
Source Patent Element
Hypertonic composition with specific osmolarity ranges
PTD Variation
Adaptive, real-time dosing module dynamically adjusting anti-platinum chemoprotectant agent concentration
Obviousness Reasoning
Dynamic dosing strategies are a predictable evolution in pharmaceutical treatment, particularly for complex medical interventions requiring precise management of therapeutic agents
Source Patent Element
Pharmaceutical compositions containing chemoprotectant agents
PTD Variation
Computer-implemented method for predicting individual ototoxicity risk scores
Obviousness Reasoning
Computational risk prediction methods are a standard approach in personalized medicine, representing an obvious application of machine learning techniques to existing pharmaceutical research
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857567 and the published technical disclosure, a person having ordinary skill in the art would find the claimed personalized ototoxicity prevention system and associated methods to be obvious variations of the prior art. The incremental technological advancements represent predictable combinations of known pharmaceutical composition techniques, machine learning applications, and medical monitoring technologies, thus rendering potential patent claims obvious under 35 U.S.C. ยง 103.

Original Patent Information

Patent NumberUS 11,857,567
TitleHypertonic pharmaceutical compositions containing an anti-platinum chemoprotectant agent
Assignee(s)Decibel Therapeutics, Inc.