Adaptive Pemafibrate Dosing Regimens for Personalized Medicine
Legal Citation
Summary of the Inventive Concept
A next-generation system for pemafibrate treatment, leveraging machine learning, artificial intelligence, and real-time biosensing to optimize dosing regimens for individual patients, ensuring safer and more effective treatment of dyslipidemia.
Background and Problem Solved
The original patent disclosed pemafibrate dosing regimens, but these were limited by a one-size-fits-all approach, neglecting individual patient differences and potential drug-drug interactions. The new inventive concept addresses this limitation by introducing adaptive dosing regimens that account for patient-specific OATP1B inhibitor interactions and utilize AI-driven predictive analytics.
Detailed Description of the Inventive Concept
The inventive concept comprises a database of patient-specific OATP1B inhibitor interactions, a machine learning algorithm to predict optimal pemafibrate doses, and a wearable device for real-time pemafibrate dosing monitoring. The system utilizes artificial intelligence to analyze patient medical histories, identify potential drug-drug interactions, and provide personalized treatment planning. A computer-implemented simulation engine enables healthcare providers to input patient-specific parameters and visualize dosing outcomes, while a cloud-based platform facilitates collaborative dosing decision support.
Novelty and Inventive Step
The new claims introduce a paradigm shift in pemafibrate treatment by integrating machine learning, artificial intelligence, and real-time biosensing to create adaptive dosing regimens. This approach is novel and non-obvious compared to the original patent, which relied on fixed dosing regimens.
Alternative Embodiments and Variations
Alternative embodiments may include the use of different AI algorithms, incorporation of additional patient data sources, or integration with electronic health records. Variations may involve adapting the system for other diseases or medications, or developing a mobile application for patient engagement and dosing reminders.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in the personalized medicine market, with applications in dyslipidemia treatment, pharmacogenomics, and precision medicine. The target industries include pharmaceutical companies, healthcare providers, and medical technology firms.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical dosing regimens, pharmacokinetics, and medical informatics, with expertise in drug metabolism, personalized medicine, and computational healthcare technologies
Person of Ordinary Skill (PHOSITA) Profile
A professional with advanced degrees in pharmacy, clinical pharmacology, or biomedical engineering, possessing knowledge of drug interactions, machine learning applications in healthcare, and computational modeling of pharmacokinetic processes
Obviousness Rationale
A PHOSITA would recognize that the PTD's machine learning and adaptive dosing approach represents a predictable technological evolution of the source patent's fixed dosing methodology. The integration of AI and real-time monitoring is a natural progression in personalized medicine, leveraging known computational techniques to optimize existing pharmaceutical treatment protocols. The core concept of dose adjustment remains consistent with the original patent, with the PTD merely introducing more sophisticated implementation strategies.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,540 |
|---|---|
| Title | Pemafibrate dosing regimens |
| Assignee(s) | KOWA COMPANY, LTD. |