Modulation of TGF-β Superfamily Signaling for Diverse Applications

Publication ID: 24-11857599_0002_PTD
Published: October 28, 2025
Category:New Applications & Use Cases

Legal Citation

pr1or.art Inc., “Modulation of TGF-β Superfamily Signaling for Diverse Applications,” Published Technical Disclosure No. 24-11857599_0002_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857599_0002_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. 11,857,599.

Summary of the Inventive Concept

The inventive concept leverages the core technology of the original patent to modulate the TGF-β superfamily signaling pathway in various contexts, enabling novel applications in agriculture, biofuel production, dermatology, diagnostics, and tissue engineering.

Background and Problem Solved

The original patent disclosed compositions and methods for treating spinal muscular atrophy (SMA) by modulating the TGF-β superfamily signaling pathway. However, the patent's scope was limited to SMA treatment. The inventive concept addresses the need for exploring alternative applications of this core technology, unlocking its potential in diverse industries and fields.

Detailed Description of the Inventive Concept

The inventive concept involves the use of recombinant ALK4:ActRIIB heteromultimers to modulate the TGF-β superfamily signaling pathway in various contexts. In agriculture, the heteromultimer is used to improve crop yields by altering plant growth and development. In biofuel production, the heteromultimer increases biofuel production by modulating the TGF-β superfamily signaling pathway in microorganisms. In dermatology, the heteromultimer reduces inflammation and promotes skin health by modulating the TGF-β superfamily signaling pathway in skin cells. In diagnostics, the heteromultimer is used in a biosensor to detect changes in the TGF-β superfamily signaling pathway, enabling disease diagnosis and monitoring. In tissue engineering, the heteromultimer promotes stem cell differentiation and tissue regeneration by modulating the TGF-β superfamily signaling pathway in stem cells.

Novelty and Inventive Step

The inventive concept is novel and non-obvious in its application of the core technology to diverse industries and fields, beyond the original patent's scope of SMA treatment. The inventive step lies in recognizing the potential of the TGF-β superfamily signaling pathway modulation in various contexts and developing specific implementations for each application.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include the use of different TGF-β superfamily ligands or receptors, or the development of novel recombinant heteromultimers with distinct binding profiles. Variations could also include the application of the inventive concept to other industries, such as veterinary medicine or environmental remediation.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in various industries, including agriculture, biofuel production, dermatology, diagnostics, and tissue engineering. The market for these applications is substantial, with potential revenue streams in the billions of dollars.

CPC Classifications

SectionClassGroup
A A61 A61K38/1841
A A61 A61K31/7125
A A61 A61K38/18
A A61 A61K45/06
A A61 A61P21/00
C C07 C07K14/71
C C12 C12N15/113
A A61 A61K38/179
C C07 C07K2319/30
C C07 C07K2319/32
C C12 C12N2310/11
C C12 C12N2320/31

Field of Art

Biotechnology and molecular medicine, specifically focused on protein engineering, receptor signaling pathways, and therapeutic interventions for genetic disorders

Person of Ordinary Skill (PHOSITA) Profile

A skilled practitioner with advanced degrees in molecular biology, biochemistry, or bioengineering, possessing expertise in protein design, recombinant protein technologies, and signal transduction mechanisms

Obviousness Rationale

A PHOSITA would recognize that the core ALK4:ActRIIB heteromultimer technology from the source patent represents a versatile platform for modulating TGF-β superfamily signaling across multiple biological contexts. The fundamental mechanism of receptor interaction and signaling pathway modulation is consistent across the source patent's SMA treatment and the PTD's proposed applications. Given the well-understood principles of receptor engineering and signal transduction, extending the technology to diverse fields would be a predictable and obvious variation.

Obvious Combinations & Variations

Source Patent Element
Recombinant ALK4:ActRIIB heteromultimer for treating neuromuscular disorders
PTD Variation
Applying the heteromultimer to modulate plant growth and development in agriculture
Obviousness Reasoning
A PHOSITA would recognize that TGF-β signaling pathways are conserved across biological systems, making it obvious to explore receptor modulation in plant cellular contexts as an extension of the original protein engineering approach
Source Patent Element
Fusion protein design targeting specific cellular signaling pathways
PTD Variation
Using the heteromultimer in biosensor technologies for disease diagnostics
Obviousness Reasoning
Adapting protein interaction technologies for diagnostic purposes is a known technique, and a PHOSITA would find it obvious to leverage the specific binding characteristics of the ALK4:ActRIIB heteromultimer for detection mechanisms
Source Patent Element
Modulation of cellular signaling to address genetic disorder complications
PTD Variation
Applying the heteromultimer to promote stem cell differentiation in tissue engineering
Obviousness Reasoning
The predictable result of modulating cellular signaling pathways makes it obvious to extend the technology to stem cell research, as the fundamental mechanism of receptor interaction remains consistent
Source Patent Element
Therapeutic protein design targeting neuromuscular conditions
PTD Variation
Developing topical formulations for dermatological inflammation reduction
Obviousness Reasoning
A PHOSITA would recognize that protein-based signaling modulators can be adapted to different delivery mechanisms and tissue contexts as a matter of routine engineering design
Source Patent Element
Recombinant protein technology for cellular signaling intervention
PTD Variation
Enhancing biofuel production by modulating microbial cellular pathways
Obviousness Reasoning
Extending protein engineering techniques to industrial biotechnology represents a predictable variation that a skilled practitioner would find obvious given the fundamental principles of signal transduction
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857599 and the disclosed variations, a person of ordinary skill in the art would find the proposed applications of the ALK4:ActRIIB heteromultimer technology across agriculture, diagnostics, tissue engineering, and other fields to be obvious variations that do not represent a non-obvious inventive step. The fundamental protein engineering approach and understanding of TGF-β signaling pathways render the proposed extensions predictable and within the scope of ordinary creativity in the art.

Original Patent Information

Patent NumberUS 11,857,599
TitleCompositions and methods for treating spinal muscular atrophy
Assignee(s)ACCELERON PHARMA INC.