Alpha-1 Antitrypsin Applications Beyond Hematopoietic Cell Transplantation

Publication ID: 24-11857610_0007_PTD
Published: October 28, 2025
Category:New Applications & Use Cases

Legal Citation

pr1or.art Inc., “Alpha-1 Antitrypsin Applications Beyond Hematopoietic Cell Transplantation,” Published Technical Disclosure No. 24-11857610_0007_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857610_0007_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

This inventive concept explores the application of alpha-1 antitrypsin (A1AT) in novel therapeutic areas beyond hematopoietic cell transplantation, including cardiovascular disease, chronic obstructive pulmonary disease, surgical procedures, acute respiratory distress syndrome, and neuroinflammation.

Background and Problem Solved

The original patent disclosed methods for reducing the risk of acute graft versus host disease after hematopoietic cell transplantation using A1AT. However, the potential benefits of A1AT are not limited to this specific application. The new inventive concept addresses the need for A1AT-based treatments in other disease areas, leveraging its anti-inflammatory and protease-inhibiting properties.

Detailed Description of the Inventive Concept

The new claims describe various methods and systems for applying A1AT in different therapeutic areas. For instance, Claim 1 proposes a system for reducing cardiovascular disease risk in patients undergoing percutaneous coronary intervention by administering A1AT prior to and following the procedure. Claim 2 describes a method for treating chronic obstructive pulmonary disease using A1AT via inhalation. Other claims cover the use of A1AT in surgical procedures, acute respiratory distress syndrome, and neuroinflammation. These novel applications take advantage of A1AT's ability to modulate the immune response and mitigate tissue damage.

Novelty and Inventive Step

The new claims introduce novel and non-obvious applications of A1AT beyond hematopoietic cell transplantation, demonstrating a significant inventive step. The specific dosing regimens, administration routes, and patient populations targeted in each claim are distinct from the original patent and provide a new direction for A1AT-based therapies.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept may include varying A1AT dosages, administration frequencies, or routes of administration to optimize treatment outcomes. Additionally, the use of A1AT in combination with other therapeutic agents or in conjunction with other medical interventions may be explored to further expand its therapeutic potential.

Potential Commercial Applications and Market

The new inventive concept has significant commercial potential in various industries, including cardiovascular, respiratory, and neurological disease treatment markets. The ability to leverage A1AT's benefits in multiple therapeutic areas could lead to the development of a robust product pipeline and expanded market opportunities for CSL Behring AG.

CPC Classifications

SectionClassGroup
A A61 A61K38/57
A A61 A61K35/12
A A61 A61P37/06
A A61 A61K2035/124

Field of Art

Medical therapeutics, specifically immunomodulatory protein treatments, with expertise in protein administration, dosage optimization, and therapeutic applications across multiple medical domains including transplantation, inflammatory conditions, and tissue repair

Person of Ordinary Skill (PHOSITA) Profile

A medical researcher or clinician with advanced training in protein therapeutics, immunology, and clinical pharmacology, possessing knowledge of protein administration techniques, dosage scaling, and cross-domain therapeutic applications

Obviousness Rationale

A person having ordinary skill would recognize alpha-1 antitrypsin's (A1AT) fundamental immunomodulatory and anti-inflammatory properties, enabling predictable extension of its therapeutic mechanism across multiple medical conditions. The source patent establishes A1AT's efficacy in modulating immune responses during hematopoietic cell transplantation, which provides a clear scientific foundation for exploring similar immunological interventions in other disease states. The PTD's variations represent logical extrapolations of A1AT's known biological mechanisms, utilizing standard medical research techniques of identifying protein therapeutic applications.

Obvious Combinations & Variations

Source Patent Element
A1AT administration for reducing immune-mediated tissue damage during hematopoietic cell transplantation
PTD Variation
Applying A1AT to reduce cardiovascular inflammation during percutaneous coronary intervention
Obviousness Reasoning
Known anti-inflammatory protein mechanism can be predictably applied to similar inflammatory pathological processes using standard dose-scaling and administration techniques
Source Patent Element
Specific A1AT dosing regimens of 120-180 mg/kg
PTD Variation
Maintaining similar dosage ranges across different medical conditions like COPD and neuroinflammation
Obviousness Reasoning
Protein dosage optimization follows predictable pharmacological principles, with minor adjustments based on specific therapeutic targets
Source Patent Element
Immunosuppressive treatment protocol involving A1AT administration
PTD Variation
Extending immunomodulatory approach to acute respiratory distress syndrome and surgical procedures
Obviousness Reasoning
Generalized understanding of protein's immune-regulating capabilities suggests transferable therapeutic strategy across inflammatory conditions
Source Patent Element
Multiple administration timeframes and routes in original HCT protocol
PTD Variation
Introducing varied administration windows like 'within 24 hours' or 'within 12 hours' for different conditions
Obviousness Reasoning
Clinical protocol design represents standard medical research approach of identifying optimal intervention windows using known therapeutic agents
Source Patent Element
A1AT as an immunomodulatory protein in transplantation context
PTD Variation
Exploring A1AT's potential in neurological and respiratory inflammatory conditions
Obviousness Reasoning
Systematic exploration of protein's mechanism across related pathological domains represents expected scientific investigation strategy
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857610, a person having ordinary skill in medical therapeutics would find the variations disclosed in the Published Technical Disclosure to represent obvious extensions of the fundamental A1AT therapeutic approach, demonstrating predictable application of known immunomodulatory protein mechanisms across multiple medical domains through standard research and clinical translation techniques.

Original Patent Information

Patent NumberUS 11,857,610
TitleMethods for reducing risk of onset of acute graft versus host disease after hematopoietic cell transplantation
Assignee(s)CSL Behring AG