Personalized Pemafibrate Dosing Regimens for Enhanced Safety and Efficacy

Publication ID: 24-11857540_0001_PTD

Published: October 28, 2025

Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Personalized Pemafibrate Dosing Regimens for Enhanced Safety and Efficacy,” Published Technical Disclosure No. 24-11857540_0001_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857540_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. 11,857,540.

Summary of the Inventive Concept

A novel system and method for optimizing pemafibrate dosing regimens in patients taking OATP1B inhibitors, ensuring personalized and safe treatment of dyslipidemia.

Background and Problem Solved

The original pemafibrate dosing regimens patent (Patent Literature 1) has limitations in addressing the risk of adverse interactions with OATP1B inhibitors, which can lead to reduced efficacy and increased toxicity. The present inventive concept solves this problem by introducing a system and method for adjusting pemafibrate dosing based on the type and amount of OATP1B inhibitor being administered.

Detailed Description of the Inventive Concept

The inventive concept comprises a dosing calculator configured to adjust the daily dose of pemafibrate based on the type and amount of OATP1B inhibitor being administered. This is achieved through a personalized approach, considering the patient's medical history and genetic profile. The system can also provide real-time monitoring of liver enzyme levels, enabling dynamic dose adjustments to ensure safe and effective treatment. The inventive concept can be implemented through various embodiments, including a computer-readable storage medium storing a program for optimizing pemafibrate dosing regimens.

Novelty and Inventive Step

The new claims introduce a novel system and method for optimizing pemafibrate dosing regimens, which is not obvious from the original patent. The inventive concept's personalized approach and real-time monitoring capabilities provide a significant improvement over existing pemafibrate dosing regimens.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept may include mobile applications, wearable devices, or cloud-based platforms for optimizing pemafibrate dosing regimens. Variations of the system may incorporate machine learning algorithms to predict optimal dosing regimens based on patient data and medical history.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in the pharmaceutical industry, particularly in the treatment of dyslipidemia. The system and method can be licensed to pharmaceutical companies, hospitals, and clinics, providing a competitive advantage in the market. The target industries include pharmaceutical manufacturing, healthcare services, and medical technology.

Section 103 Obviousness Analysis (PHOSITA)

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Field of Art

Pharmaceutical dosing optimization, specifically in the domain of lipid metabolism therapeutics and drug interaction management, with expertise in pharmacokinetics, clinical dosing strategies, and computational healthcare technologies

Person of Ordinary Skill (PHOSITA) Profile

A pharmaceutical researcher or clinical pharmacologist with advanced training in drug metabolism, computational modeling of drug interactions, and personalized medicine techniques, possessing knowledge of OATP1B transporters and pharmacogenomic variability

Obviousness Rationale

A PHOSITA would recognize that the PTD's personalized dosing approach represents a natural extension of the source patent's core teachings about pemafibrate dose modulation, leveraging known computational and clinical monitoring techniques to address drug interaction complexities inherent in the original dosing methodology.

Obvious Combinations & Variations

Source Patent Element

Original patent's method of reducing pemafibrate dosage from 0.4 mg to 0.1-0.2 mg

PTD Variation

Implementing a dynamic dosing calculator that adjusts pemafibrate doses based on OATP1B inhibitor interactions

Obviousness Reasoning

Predictable application of known computational dosing optimization techniques to an existing pharmaceutical dosing protocol, representing a routine design choice for managing drug interactions

Source Patent Element

Patent's focus on clarithromycin interactions with pemafibrate

PTD Variation

Expanding interaction analysis to broader OATP1B inhibitor classes and implementing real-time liver enzyme monitoring

Obviousness Reasoning

Logical extension of existing drug interaction research, utilizing standard clinical monitoring techniques to enhance patient safety in a predictable manner

Source Patent Element

Original patent's fixed dose reduction methodology

PTD Variation

Introducing personalized dosing recommendations based on patient genetic profile and medical history

Obviousness Reasoning

Application of well-established pharmacogenomic principles to create individualized treatment protocols, representing an obvious improvement in precision medicine approaches

Source Patent Element

Base patent's pharmaceutical dosing framework for dyslipidemia treatment

PTD Variation

Developing computational platforms and mobile applications for dynamic dose management

Obviousness Reasoning

Routine technological implementation of existing clinical protocols using standard software engineering techniques, representing a predictable technological evolution

35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857540 and the disclosed variations, a person of ordinary skill in the art would find the claimed personalized pemafibrate dosing system and methods to be obvious variations of the prior art, lacking inventive step under 35 U.S.C. § 103, as the proposed innovations represent predictable applications of known pharmaceutical dosing optimization techniques to existing clinical methodologies.

Original Patent Information

Patent Number	US 11,857,540
Title	Pemafibrate dosing regimens
Assignee(s)	KOWA COMPANY, LTD.