Personalized Solriamfetol Therapy System for Impaired Renal Function

Publication ID: 24-11857528_0010_PTD
Published: October 28, 2025
Category:Future Evolutions & Paradigm Shifts

Legal Citation

pr1or.art Inc., “Personalized Solriamfetol Therapy System for Impaired Renal Function,” Published Technical Disclosure No. 24-11857528_0010_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857528_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. 11,857,528.

Summary of the Inventive Concept

A next-generation solriamfetol therapy system that leverages machine learning, wearable devices, and cloud-based analytics to provide personalized dosing regimens, real-time efficacy monitoring, and collaborative care management for subjects with impaired renal function.

Background and Problem Solved

The original patent disclosed methods for decreasing adverse effects associated with solriamfetol therapy in subjects with impaired renal function. However, these methods rely on static dosing regimens and do not account for individualized kidney function metrics, medical history, or real-time therapy efficacy monitoring. The new inventive concept addresses these limitations by introducing a personalized solriamfetol therapy system that adapts to the subject's unique needs and renal function in real-time.

Detailed Description of the Inventive Concept

The system comprises a machine learning module that predicts optimal dosing regimens based on individualized kidney function metrics and medical history. Wearable devices and artificial intelligence-powered analytics enable real-time monitoring of solriamfetol therapy efficacy. A novel solriamfetol formulation with a targeted release mechanism adapts to the subject's renal function in real-time, ensuring optimal drug delivery and minimizing adverse effects. A cloud-based platform facilitates collaborative care management, enabling seamless communication between healthcare providers and real-time data analysis. A wearable device tracks solriamfetol therapy adherence and detects potential adverse effects, providing personalized alerts and recommendations to healthcare providers.

Novelty and Inventive Step

The new claims introduce a paradigm shift in solriamfetol therapy by integrating machine learning, wearable devices, and cloud-based analytics to provide personalized and adaptive dosing regimens. This is a significant departure from the original patent's static dosing regimens, demonstrating a novel and non-obvious approach to solriamfetol therapy.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include the use of other machine learning algorithms, different wearable device form factors, or integration with electronic health records. Variations of the system could be designed for specific patient populations, such as pediatric or geriatric subjects.

Potential Commercial Applications and Market

The personalized solriamfetol therapy system has significant commercial potential in the pharmaceutical and healthcare industries, particularly in the areas of sleep disorders, nephrology, and personalized medicine. The system's ability to provide real-time efficacy monitoring and adaptive dosing regimens could lead to improved patient outcomes, reduced healthcare costs, and increased market share for solriamfetol therapy providers.

Field of Art

Pharmaceutical therapeutics, medical device technology, and digital health systems focused on personalized drug delivery and patient monitoring for renal impairment treatment

Person of Ordinary Skill (PHOSITA) Profile

A multidisciplinary professional with expertise in clinical pharmacology, medical device engineering, machine learning, and digital health technologies, possessing advanced knowledge of drug dosing strategies for patients with compromised kidney function

Obviousness Rationale

A PHOSITA would recognize that integrating digital monitoring technologies with personalized drug dosing represents a predictable extension of existing pharmaceutical treatment methodologies. The source patent's focus on precise solriamfetol dosing for renal impairment naturally suggests technological augmentation to optimize patient outcomes. Machine learning and real-time monitoring are well-established techniques for personalizing medical interventions, making the PTD's approach a logical progression of the original patent's core therapeutic objectives.

Obvious Combinations & Variations

Source Patent Element
Precise dosing methodology for solriamfetol in patients with renal impairment
PTD Variation
Machine learning module predicting optimal dosing based on individualized kidney function metrics
Obviousness Reasoning
Predictable application of machine learning to existing dosing protocols, representing a known technique for personalizing medical treatments
Source Patent Element
Treatment of excessive daytime sleepiness in subjects with renal impairment
PTD Variation
Wearable devices and AI-powered analytics for real-time therapy efficacy monitoring
Obviousness Reasoning
Logical extension of patient monitoring technologies to track therapeutic effectiveness, utilizing standard digital health approaches
Source Patent Element
Targeted oral dosing for subjects with specific eGFR ranges
PTD Variation
Solriamfetol formulation with adaptive targeted release mechanism responding to real-time renal function
Obviousness Reasoning
Predictable pharmaceutical engineering solution addressing variability in patient kidney function, representing a finite set of design modifications
Source Patent Element
Medical treatment protocol for solriamfetol administration
PTD Variation
Cloud-based collaborative care management platform enabling provider communication
Obviousness Reasoning
Known digital health integration technique for improving medical treatment coordination and data sharing
Source Patent Element
Managing adverse effects in solriamfetol therapy
PTD Variation
Wearable device tracking therapy adherence and detecting potential adverse effects
Obviousness Reasoning
Standard patient monitoring approach applying established digital health technologies to pharmaceutical treatment tracking
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857528 and the published technical disclosure, a person of ordinary skill in the art would find the claimed personalized solriamfetol therapy system with machine learning, adaptive dosing, and digital monitoring technologies to be an obvious variation of the prior art, rendering subsequent claims covering similar technological implementations anticipated and non-patentable.

Original Patent Information

Patent NumberUS 11,857,528
TitleMethods of providing solriamfetol therapy to subjects with impaired renal function
Assignee(s)AXSOME MALTA LTD.