Personalized Pemafibrate Dosing Systems

Publication ID: 24-11857540_0010_PTD
Published: October 28, 2025
Category:Future Evolutions & Paradigm Shifts

Legal Citation

pr1or.art Inc., “Personalized Pemafibrate Dosing Systems,” Published Technical Disclosure No. 24-11857540_0010_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857540_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. 11,857,540.

Summary of the Inventive Concept

The present invention relates to a next-generation pemafibrate dosing system that leverages machine learning, wearable devices, and targeted delivery to optimize treatment outcomes and minimize adverse effects.

Background and Problem Solved

The original patent disclosed pemafibrate dosing regimens, but these regimens have limitations in terms of individual patient variability and response to OATP1B inhibitors. The present inventive concept addresses these limitations by introducing personalized and adaptive dosing approaches that account for genetic profiles, dynamic responses, and liver-specific biomarkers.

Detailed Description of the Inventive Concept

The inventive concept comprises a system for personalized pemafibrate dosing, utilizing a database of patient genetic profiles and a machine learning algorithm to predict optimal dosing regimens. Additionally, the system includes methods for adaptive pemafibrate dosing, wherein the dosage is adjusted in real-time based on a patient's dynamic response to OATP1B inhibitors, as monitored by a wearable device or mobile application. Furthermore, the inventive concept encompasses pemafibrate formulations for targeted delivery to the liver, comprising nanoparticle or liposome carriers that selectively release the active compound in response to liver-specific biomarkers.

Novelty and Inventive Step

The new claims introduce a paradigm shift in pemafibrate dosing by incorporating machine learning, wearable devices, and targeted delivery. These innovations are non-obvious and novel compared to the original patent, which focused on fixed dosing regimens.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept may include the use of different machine learning algorithms, wearable devices, or targeted delivery mechanisms. Variations may also include the integration of additional data sources, such as electronic health records or genomic data, to further personalize pemafibrate dosing.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in the pharmaceutical and healthcare industries, particularly in the treatment of dyslipidemia and related cardiovascular diseases. The targeted delivery and adaptive dosing approaches may also have applications in other therapeutic areas, such as oncology and immunology.

Field of Art

Pharmaceutical drug delivery systems, pharmacogenomics, and personalized medicine, with expertise in lipid metabolism treatments and drug dosing optimization

Person of Ordinary Skill (PHOSITA) Profile

A professional with advanced training in pharmaceutical sciences, pharmacology, or biomedical engineering, possessing knowledge of machine learning, drug delivery technologies, and personalized medicine approaches

Obviousness Rationale

A PHOSITA would recognize that the personalized dosing system represents a predictable extension of existing pemafibrate treatment methodologies, leveraging known technologies in machine learning, biosensors, and targeted drug delivery to address inherent variability in patient responses to the medication.

Obvious Combinations & Variations

Source Patent Element
Fixed dosing regimen of 0.4 mg pemafibrate with potential dose adjustments
PTD Variation
Real-time adaptive dosing using machine learning and wearable device monitoring
Obviousness Reasoning
Predictable application of digital health technologies to optimize existing drug dosing strategies, representing a natural progression in personalized medicine approaches
Source Patent Element
Treatment of dyslipidemia using pemafibrate
PTD Variation
Targeted liver delivery using nanoparticle or liposome carriers
Obviousness Reasoning
Known drug delivery enhancement technique to improve pharmacokinetics and reduce systemic side effects, using standard pharmaceutical engineering principles
Source Patent Element
Patient-specific dosing considerations
PTD Variation
Genetic profile-based predictive dosing algorithm
Obviousness Reasoning
Logical extension of personalized medicine concepts, utilizing established machine learning techniques to optimize drug treatment based on individual patient characteristics
Source Patent Element
Interaction with OATP1B inhibitors like clarithromycin
PTD Variation
Comprehensive risk assessment using genetic and clinical data predictive models
Obviousness Reasoning
Systematic approach to understanding drug interactions by integrating multiple data sources, representing a standard approach in contemporary pharmacogenomics
Source Patent Element
Fixed dosing protocol for pemafibrate
PTD Variation
Closed-loop biosensor system for continuous dosage adjustment
Obviousness Reasoning
Predictable technological advancement in drug monitoring, applying well-established feedback control principles to pharmaceutical treatment
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857540 and the disclosed personalized dosing technologies, a person having ordinary skill in the art would find the claimed variations obvious, as they represent predictable applications of known machine learning, biosensor, and targeted drug delivery technologies to existing pemafibrate treatment methodologies, thereby rendering subsequent claims of novelty invalid under 35 U.S.C. Section 103.

Original Patent Information

Patent NumberUS 11,857,540
TitlePemafibrate dosing regimens
Assignee(s)KOWA COMPANY, LTD.