Programmable Nanocarrier-Based Targeted Cellular Delivery of Shiga Toxin A Subunit Effector Polypeptides

Publication ID: 24-11857628_0010_PTD
Published: October 28, 2025
Category:Future Evolutions & Paradigm Shifts

Legal Citation

pr1or.art Inc., “Programmable Nanocarrier-Based Targeted Cellular Delivery of Shiga Toxin A Subunit Effector Polypeptides,” Published Technical Disclosure No. 24-11857628_0010_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857628_0010_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. 11,857,628.

Summary of the Inventive Concept

A next-generation targeted cellular delivery system utilizing programmable nanocarriers and optimized cell-targeting molecules to enhance the efficacy and specificity of Shiga toxin A subunit effector polypeptide-based therapies.

Background and Problem Solved

The original patent disclosed cell-targeting molecules comprising Shiga toxin effector polypeptides, but these molecules had limitations in terms of delivery efficiency and specificity. The new inventive concept addresses these limitations by introducing programmable nanocarriers that can be tailored to specific cell types, thereby enhancing the targeted delivery of Shiga toxin A subunit effector polypeptides.

Detailed Description of the Inventive Concept

The new inventive concept comprises a system for targeted cellular delivery of Shiga toxin A subunit effector polypeptides, featuring a nanocarrier with a programmable surface chemistry and a cell-targeting molecule conjugated to the nanocarrier. The cell-targeting molecule is configured to selectively bind to a specific cell type and facilitate uptake of the nanocarrier. The nanocarrier can be a liposome with a dynamic lipid bilayer composition, allowing for real-time optimization of the surface chemistry. The cell-targeting molecule can be generated through a high-throughput, microfluidics-based assay, enabling rapid screening and selection of variants with improved binding affinity and specificity.

Novelty and Inventive Step

The new claims introduce the concept of programmable nanocarriers, which is a significant departure from the original patent's focus on cell-targeting molecules alone. The combination of programmable nanocarriers and optimized cell-targeting molecules provides a novel and non-obvious solution for targeted cellular delivery of Shiga toxin A subunit effector polypeptides.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include the use of different types of nanocarriers, such as nanoparticles or viral vectors, or the incorporation of additional functional elements, such as imaging agents or therapeutic payloads. Variations of the cell-targeting molecule could include different Shiga toxin effector polypeptide variants or alternative binding regions.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in the development of targeted therapies for various diseases, including cancer and inflammatory disorders. The ability to selectively deliver Shiga toxin A subunit effector polypeptides to specific cell types could lead to improved treatment outcomes and reduced side effects. The market for targeted therapies is growing rapidly, with an estimated value of over $10 billion by 2025.

CPC Classifications

SectionClassGroup
A A61 A61K45/06
A A61 A61K38/00
A A61 A61K38/164
A A61 A61K47/6829
C C07 C07K14/195
C C07 C07K14/25
A A61 A61K2039/6037
C C07 C07K2319/05
C C07 C07K2319/55

Field of Art

Biotechnology and pharmaceutical engineering, specifically focused on targeted cellular delivery systems, protein engineering, and nanocarrier design. Requires advanced knowledge of molecular biology, protein modification techniques, and drug delivery strategies

Person of Ordinary Skill (PHOSITA) Profile

A PhD-level researcher with expertise in protein engineering, nanotechnology, and targeted drug delivery. Skilled in microfluidics, protein variant screening, and understanding structure-function relationships of biomolecules

Obviousness Rationale

A PHOSITA would recognize that the programmable nanocarrier approach represents a predictable extension of existing targeted delivery technologies. The combination of Shiga toxin A subunit effector polypeptides with programmable nanocarriers follows established principles of targeted drug delivery. The high-throughput screening method for optimizing cell-targeting molecules is a standard approach in protein engineering that would be obvious to implement given the source patent's foundational work.

Obvious Combinations & Variations

Source Patent Element
Cell-targeting molecule with specific Shiga toxin effector polypeptide modifications
PTD Variation
Programmable nanocarrier with dynamically configurable surface chemistry for conjugating cell-targeting molecules
Obviousness Reasoning
Combining targeted molecular delivery with adaptable nanocarrier platforms is a predictable solution in drug delivery engineering, representing a known technique for improving cellular targeting
Source Patent Element
Specific amino acid substitutions in Shiga toxin effector polypeptides (e.g., R248A, R251A)
PTD Variation
High-throughput microfluidics-based screening of polypeptide variants for optimized binding properties
Obviousness Reasoning
Systematic variant screening is a standard protein engineering approach for identifying improved molecular interactions, representing a finite and predictable optimization strategy
Source Patent Element
Cell-targeting molecules with binding regions for extracellular biomolecules
PTD Variation
Nanocarrier-conjugated cell-targeting molecules with selective cell type binding capabilities
Obviousness Reasoning
Enhancing cellular specificity through targeted molecular design is a well-established technique in drug delivery, following predictable engineering principles
Source Patent Element
Shiga toxin A subunit effector polypeptide base structure
PTD Variation
Incorporation of additional functional elements like imaging agents or therapeutic payloads
Obviousness Reasoning
Multifunctional molecular design is a common strategy in biotechnology, representing an obvious extension of existing molecular engineering techniques
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857628 and the published technical disclosure, a person of ordinary skill in the art would find the claimed variations in targeted cellular delivery systems and cell-targeting molecule optimization to be obvious and predictable extensions of the prior art. The disclosed methods represent routine engineering approaches within the established framework of protein and nanocarrier design, thus rendering potential claims in this domain obvious and unpatentable under 35 U.S.C. ยง 103.

Original Patent Information

Patent NumberUS 11,857,628
TitleShiga toxin A subunit effector polypeptides, Shiga toxin effector scaffolds, and cell-targeting molecules for site-specific conjugation
Assignee(s)Molecular Templates, Inc.