Enhanced Pharmaceutical Composition for Cancer Treatment

Publication ID: 24-11857601_0001_PTD

Published: October 28, 2025

Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Pharmaceutical Composition for Cancer Treatment,” Published Technical Disclosure No. 24-11857601_0001_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857601_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. 11,857,601.

Summary of the Inventive Concept

An improved pharmaceutical composition for cancer treatment comprising a fusion protein dimer of CD80 and IL-2, and an anticancer agent, with enhanced stability, bioavailability, and immune response.

Background and Problem Solved

The original patent disclosed a pharmaceutical composition for cancer treatment, but it had limitations in terms of stability, bioavailability, and immune response. The new inventive concept addresses these limitations by modifying the fusion protein dimer to enhance its stability and bioavailability, and by using sustained-release formulations and targeted therapies to improve treatment outcomes.

Detailed Description of the Inventive Concept

The new inventive concept comprises a fusion protein dimer of CD80 and IL-2, which is modified to enhance its stability and bioavailability. The fusion protein dimer is administered with an anticancer agent, which can be selected from a group of targeted therapies. The pharmaceutical composition can be administered via a sustained-release formulation to improve treatment outcomes. Additionally, the new inventive concept includes a system for monitoring the efficacy of the pharmaceutical composition, which comprises a biomarker for tracking immune response. The new inventive concept also includes a method for enhancing the immune activity of the pharmaceutical composition by co-administering an immune checkpoint inhibitor.

Novelty and Inventive Step

The new inventive concept is novel and non-obvious compared to the original patent because it provides a modified fusion protein dimer with enhanced stability and bioavailability, and it uses sustained-release formulations and targeted therapies to improve treatment outcomes. The new inventive concept also includes a system for monitoring the efficacy of the pharmaceutical composition and a method for enhancing the immune activity of the pharmaceutical composition, which are not disclosed in the original patent.

Alternative Embodiments and Variations

Alternative embodiments of the new inventive concept include using different types of anticancer agents, such as chemotherapy drugs or hormone therapy drugs, and using different types of sustained-release formulations, such as nanoparticles or liposomes. Additionally, the new inventive concept can be used in combination with other cancer treatments, such as radiation therapy or surgery.

Potential Commercial Applications and Market

The new inventive concept has significant commercial potential in the cancer treatment market, which is expected to grow significantly in the coming years. The new inventive concept can be used to treat various types of cancer, including solid tumors and hematological malignancies. The target industries for the new inventive concept include pharmaceutical companies, biotechnology companies, and hospitals and clinics.

CPC Classifications

Section	Class	Group
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

Section 103 Obviousness Analysis (PHOSITA)

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Field of Art

Pharmaceutical biotechnology, specifically cancer immunotherapy and protein engineering, involving complex protein fusion designs and targeted cancer treatment strategies

Person of Ordinary Skill (PHOSITA) Profile

A PhD-level researcher with expertise in protein engineering, immunology, and cancer therapeutics, familiar with fusion protein design, targeted drug delivery, and combination cancer treatment approaches

Obviousness Rationale

A person having ordinary skill would recognize that the PTD's modifications to the source patent's fusion protein composition represent predictable variations within established pharmaceutical engineering practices. The proposed enhancements in stability, bioavailability, and targeted delivery are logical extensions of known techniques in protein therapeutic design. The systematic approach of combining fusion proteins with sustained-release formulations and additional therapeutic strategies represents incremental innovation typical in cancer treatment research.

Obvious Combinations & Variations

Source Patent Element

Fusion protein dimer comprising CD80 fragment and IL-2 variant for cancer treatment

PTD Variation

Modified fusion protein with enhanced stability and bioavailability

Obviousness Reasoning

Protein engineering techniques for improving therapeutic protein stability are well-established and would be a predictable optimization for a skilled researcher

Source Patent Element

Pharmaceutical composition with anticancer agents

PTD Variation

Sustained-release formulation and targeted therapy selection

Obviousness Reasoning

Developing controlled-release drug delivery systems is a known strategy for improving pharmacokinetic properties, representing an obvious design choice

Source Patent Element

Cancer treatment composition with fusion protein

PTD Variation

Co-administration with immune checkpoint inhibitor

Obviousness Reasoning

Combination immunotherapy strategies are well-documented in oncology, making this approach a predictable extension of existing treatment paradigms

Source Patent Element

Anticancer agent selection in pharmaceutical composition

PTD Variation

Expanded anticancer agent selection including targeted therapies

Obviousness Reasoning

Selection of alternative therapeutic agents within known classes represents a routine optimization process for a skilled researcher

Source Patent Element

Cancer treatment pharmaceutical composition

PTD Variation

Biomarker-based efficacy monitoring system

Obviousness Reasoning

Developing companion diagnostic approaches is a standard practice in personalized medicine, representing an obvious improvement to existing treatment methodologies

35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857601, the variations disclosed in this Published Technical Disclosure would be considered obvious to a person having ordinary skill in pharmaceutical biotechnology. The systematic modifications to fusion protein design, drug delivery, and combination therapeutic strategies represent predictable extensions of existing knowledge, thereby rendering potential patent claims obvious under 35 U.S.C. § 103.

Original Patent Information

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