Enhanced Fusion Protein-Based Cancer Treatment System

Publication ID: 24-11857601_0006_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Fusion Protein-Based Cancer Treatment System,” Published Technical Disclosure No. 24-11857601_0006_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857601_0006_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. 11,857,601.

Summary of the Inventive Concept

A novel system for cancer treatment that combines a fusion protein dimer comprising CD80 and IL-2 proteins with an anticancer agent, featuring sustained release formulation, modified half-life, and personalized treatment options to enhance immune activity and reduce toxicity.

Background and Problem Solved

The original patent disclosed a pharmaceutical composition for cancer treatment comprising a fusion protein dimer and an anticancer agent. However, the composition's effectiveness was limited by its short half-life, lack of sustained release, and potential toxicity. The new inventive concept addresses these limitations by introducing sustained release formulations, modified half-life, and personalized treatment options to enhance immune activity and reduce toxicity.

Detailed Description of the Inventive Concept

The new system comprises a fusion protein dimer comprising CD80 and IL-2 proteins, which is administered in a sustained release formulation to enhance immune activity over an extended period. The fusion protein dimer can be modified to have a longer half-life, allowing for more efficient treatment. Additionally, the system can be adapted for personalized cancer treatment by detecting and responding to the specific genetic profile of a patient's cancer cells. The system can also be combined with an immune checkpoint inhibitor to further enhance the immune response. Furthermore, the system can be designed to target specific cancer cells and minimize damage to healthy cells, reducing toxicity.

Novelty and Inventive Step

The new claims introduce novel and non-obvious features, including sustained release formulations, modified half-life, and personalized treatment options, which significantly enhance the effectiveness and safety of the original pharmaceutical composition.

Alternative Embodiments and Variations

Alternative embodiments of the system could include different sustained release formulations, such as nanoparticles or liposomes, or different methods for modifying the half-life of the fusion protein dimer. Additionally, the system could be adapted for use with different types of cancer or combined with other therapies, such as chemotherapy or radiation therapy.

Potential Commercial Applications and Market

The enhanced fusion protein-based cancer treatment system has significant commercial potential in the oncology market, with potential applications in various types of cancer, including solid tumors and hematological malignancies. The system's ability to enhance immune activity and reduce toxicity makes it an attractive option for patients and healthcare providers.

CPC Classifications

SectionClassGroup
A A61 A61K38/2013
A A61 A61K31/337
A A61 A61K31/444
A A61 A61K31/4439
A A61 A61K31/47
A A61 A61K31/4709
A A61 A61K31/502
A A61 A61K31/506
A A61 A61K31/5025
A A61 A61K31/519
A A61 A61K31/708
A A61 A61K33/243
A A61 A61K38/1774
A A61 A61K39/3955
A A61 A61K45/06
A A61 A61P35/00

Field of Art

Pharmaceutical biotechnology, specifically immunooncology and protein engineering, focusing on fusion protein design for cancer immunotherapy

Person of Ordinary Skill (PHOSITA) Profile

A PhD-level researcher with expertise in protein engineering, immunology, and cancer treatment, familiar with protein modification techniques, drug delivery systems, and targeted therapeutic strategies

Obviousness Rationale

A person of ordinary skill would recognize that the PTD's variations represent predictable extensions of the source patent's core technology, applying standard protein engineering and drug delivery techniques to enhance the existing fusion protein cancer treatment approach. The modifications of sustained release, half-life extension, and targeted delivery are well-established strategies in biotechnology that would be obvious to implement given the source patent's foundational work. The incremental improvements demonstrate routine optimization within the field of cancer immunotherapy.

Obvious Combinations & Variations

Source Patent Element
Fusion protein dimer comprising CD80 fragment and IL-2 variant
PTD Variation
Sustained release formulation to enhance immune activity over extended period
Obviousness Reasoning
Sustained release technologies are well-known in pharmaceutical development, and a PHOSITA would recognize this as a predictable method to improve drug efficacy and patient compliance
Source Patent Element
Pharmaceutical composition with anticancer agent
PTD Variation
Addition of immune checkpoint inhibitor to enhance immune response
Obviousness Reasoning
Combination immunotherapies are a standard approach in cancer treatment, and integrating checkpoint inhibitors would be an obvious strategy to augment the existing therapeutic mechanism
Source Patent Element
Cancer treatment composition with fusion protein
PTD Variation
Personalized treatment approach detecting patient's genetic cancer cell profile
Obviousness Reasoning
Precision medicine techniques are increasingly standard, and adapting treatments based on genetic profiling represents a predictable evolution of targeted therapeutic strategies
Source Patent Element
Fusion protein with CD80 and IL-2 components
PTD Variation
Modified protein half-life to improve therapeutic efficacy
Obviousness Reasoning
Protein engineering techniques for extending half-life are well-established, including methods like PEGylation or structural modifications that would be obvious to a skilled practitioner
Source Patent Element
Anticancer pharmaceutical composition
PTD Variation
Targeted delivery mechanism to minimize damage to healthy cells
Obviousness Reasoning
Reducing off-target effects is a fundamental goal in drug design, and techniques for selective targeting are well-known in the field of cancer therapeutics
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857601, the variations disclosed in this publication would be obvious to a person having ordinary skill in the art of cancer immunotherapy. The incremental improvements represent routine optimization using known techniques in protein engineering, drug delivery, and personalized medicine, thus rendering potential claims covering similar approaches anticipated and non-patentable under 35 U.S.C. Section 103.

Original Patent Information

Patent NumberUS 11,857,601
TitlePharmaceutical composition for cancer treatment comprising fusion protein including IL-2 protein and CD80 protein and anticancer drug
Assignee(s)GI Innovation, Inc.