Personalized Acute Graft Versus Host Disease Prevention and Treatment Platform
Legal Citation
Summary of the Inventive Concept
A next-generation platform for preventing and treating acute graft versus host disease (aGVHD) in patients undergoing hematopoietic cell transplantation (HCT), leveraging machine learning, genetic profiling, and personalized medicine to improve treatment outcomes and reduce healthcare costs.
Background and Problem Solved
The original patent disclosed methods for reducing the risk of aGVHD using alpha-1 antitrypsin (A1AT) administration. However, these methods have limitations, including a one-size-fits-all approach, lack of personalized treatment, and limited understanding of genetic markers associated with aGVHD risk. The new inventive concept addresses these limitations by introducing a personalized treatment regimen generator, genetic profiling, and real-time biomarker monitoring to provide a more targeted and effective approach to aGVHD prevention and treatment.
Detailed Description of the Inventive Concept
The platform consists of four interconnected components: (1) a personalized treatment regimen generator that uses machine learning algorithms to determine an optimal dosing schedule for A1AT administration based on individual patient characteristics and treatment outcomes; (2) a genetic profiling module that analyzes a patient's genetic profile to identify genetic markers associated with increased risk of aGVHD; (3) a real-time biomarker monitoring device that detects changes in biomarker levels and alerts healthcare providers to initiate A1AT treatment in response to elevated biomarker levels; and (4) a composition for treating aGVHD that combines A1AT with a checkpoint inhibitor to enhance therapeutic effect and reduce the risk of aGVHD.
Novelty and Inventive Step
The new inventive concept introduces a paradigm shift in aGVHD prevention and treatment by integrating machine learning, genetic profiling, and real-time biomarker monitoring to provide a personalized and targeted approach. The use of machine learning algorithms to generate personalized treatment regimens and the combination of A1AT with checkpoint inhibitors are novel and non-obvious advancements over the original patent.
Alternative Embodiments and Variations
Alternative embodiments of the platform could include the use of different machine learning algorithms, incorporation of additional biomarkers or genetic markers, or modification of the composition for treating aGVHD. Variations of the platform could also be developed for specific patient populations or HCT procedures.
Potential Commercial Applications and Market
The personalized aGVHD prevention and treatment platform has significant commercial potential in the hematopoietic cell transplantation market, with potential applications in hospitals, clinics, and research institutions. The platform could also be licensed to pharmaceutical companies or biotechnology firms for further development and commercialization.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K38/57 |
| A | A61 | A61K35/12 |
| A | A61 | A61P37/06 |
| A | A61 | A61K2035/124 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Medical biotechnology focusing on hematopoietic cell transplantation (HCT), immunotherapy, and personalized medicine, with expertise in immunosuppressive treatments, genetic profiling, and biomarker analysis
Person of Ordinary Skill (PHOSITA) Profile
A medical researcher or clinician with advanced degrees in immunology, biotechnology, or medical engineering, possessing knowledge of transplantation medicine, machine learning applications in healthcare, and personalized treatment strategies
Obviousness Rationale
A PHOSITA would recognize that the PTD's machine learning-driven personalization of A1AT treatment represents a predictable application of computational techniques to existing medical protocols. The integration of genetic profiling and biomarker monitoring with established A1AT administration methods follows a logical progression of precision medicine approaches. The combination of A1AT with checkpoint inhibitors demonstrates a standard approach to enhancing therapeutic efficacy through known immunological mechanisms.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,610 |
|---|---|
| Title | Methods for reducing risk of onset of acute graft versus host disease after hematopoietic cell transplantation |
| Assignee(s) | CSL Behring AG |