Personalized Alpha-1 Antitrypsin Therapy for Reducing Acute Graft Versus Host Disease Risk

Publication ID: 24-11857610_0001_PTD

Published: October 28, 2025

Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Personalized Alpha-1 Antitrypsin Therapy for Reducing Acute Graft Versus Host Disease Risk,” Published Technical Disclosure No. 24-11857610_0001_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857610_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. 11,857,610.

Summary of the Inventive Concept

The invention provides an improved method for reducing the risk of acute graft versus host disease (aGVHD) in patients undergoing hematopoietic cell transplantation (HCT) by leveraging genetic profiling, personalized treatment schedules, and optimized alpha-1 antitrypsin (A1AT) dosing.

Background and Problem Solved

The original patent disclosed methods for reducing aGVHD risk by administering A1AT prior to and following HCT. However, these methods have limitations, including a one-size-fits-all approach to dosing and a lack of consideration for individual genetic profiles. The new inventive concept addresses these limitations by incorporating genetic profiling and personalized treatment schedules to minimize aGVHD risk.

Detailed Description of the Inventive Concept

The new inventive concept comprises a system and method for reducing aGVHD risk by administering A1AT according to a personalized treatment schedule based on the patient's genetic profile. The system includes a processor configured to analyze the patient's genetic data and determine the optimal A1AT dosage and administration schedule. The method involves monitoring the patient's cytokine levels and adjusting the A1AT dosage accordingly. Additionally, the inventive concept includes a composition for treating aGVHD, comprising A1AT and at least one immunomodulatory agent, administered in a single dose prior to HCT. A real-time monitoring system is also disclosed, comprising a sensor configured to detect biomarkers of aGVHD and a processor configured to adjust the A1AT dosage based on the detected biomarkers.

Novelty and Inventive Step

The new inventive concept provides a novel approach to aGVHD risk reduction by incorporating genetic profiling and personalized treatment schedules, which is not disclosed in the original patent. The use of genetic profiling to determine optimal A1AT dosing and administration schedules is a non-obvious improvement over the original patent.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept include using different types of genetic profiling, such as whole-genome sequencing or gene expression analysis, to determine optimal A1AT dosing. Additionally, the inventive concept could be adapted for use in other types of transplantation, such as solid organ transplantation.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in the field of hematopoietic cell transplantation, where aGVHD is a major complication. The market for aGVHD prevention and treatment is expected to grow significantly in the coming years, and the inventive concept is well-positioned to capitalize on this trend.

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)

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Field of Art

Medical biotechnology focused on hematopoietic cell transplantation (HCT), immunomodulation, and personalized medicine, with expertise in immunological interventions, genetic profiling, and therapeutic protein administration

Person of Ordinary Skill (PHOSITA) Profile

A medical researcher or clinical immunologist with advanced degrees (PhD/MD), specialized knowledge in transplantation medicine, experience with protein therapeutics, familiarity with genetic analysis techniques, and understanding of personalized treatment strategies

Obviousness Rationale

A PHOSITA would recognize that personalizing A1AT administration through genetic profiling and real-time biomarker monitoring represents a predictable extension of the source patent's core methodology of A1AT treatment for aGVHD. The proposed variations leverage standard techniques in personalized medicine and immunological monitoring that would be well-known to experts in transplantation therapeutics. The fundamental approach of optimizing protein-based interventions through patient-specific data analysis follows established paradigms in precision medicine.

Obvious Combinations & Variations

Source Patent Element

A1AT administration schedule for reducing aGVHD risk

PTD Variation

Genetic profiling to customize A1AT dosage and administration timing

Obviousness Reasoning

Personalized medicine techniques are a known approach for optimizing therapeutic interventions, and applying genetic analysis to modify protein treatment protocols would be an obvious design choice for a PHOSITA

Source Patent Element

Fixed dosing regimen of A1AT

PTD Variation

Real-time biomarker monitoring to dynamically adjust A1AT dosage

Obviousness Reasoning

Adaptive treatment strategies using biomarker feedback are standard practice in clinical immunology, representing a predictable refinement of the original treatment methodology

Source Patent Element

Basic A1AT administration for aGVHD prevention

PTD Variation

Combining A1AT with additional immunomodulatory agents in a single pre-HCT dose

Obviousness Reasoning

Combination therapies are a well-established technique in immunological interventions, and a PHOSITA would recognize the potential synergistic effects of multi-agent approaches

Source Patent Element

HCT treatment protocol focusing on aGVHD risk reduction

PTD Variation

Expanding protocol to include whole-genome sequencing for treatment optimization

Obviousness Reasoning

Advanced genetic analysis techniques are a natural progression in personalized medicine, representing an obvious technological improvement for treatment customization

Source Patent Element

A1AT administration for hematopoietic cell transplantation

PTD Variation

Extending protocol to potential applications in solid organ transplantation

Obviousness Reasoning

Cross-domain application of immunomodulatory techniques is a standard scientific approach, and a PHOSITA would recognize the potential transferability of the core therapeutic concept

35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857610 and the disclosed variations, a person of ordinary skill in the art would find the proposed personalized A1AT treatment methodologies obvious, as they represent predictable extensions of existing therapeutic approaches through standard techniques in genetic profiling, biomarker monitoring, and adaptive treatment strategies. The variations constitute obvious combinations of known elements within the field of transplantation medicine and personalized immunological interventions.

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