Specialized Formulations of SN-38 for Niche Applications

Publication ID: 24-11857630_0009_PTD
Published: October 28, 2025
Category:Specialized Variations & Niche Solutions

Legal Citation

pr1or.art Inc., “Specialized Formulations of SN-38 for Niche Applications,” Published Technical Disclosure No. 24-11857630_0009_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857630_0009_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. 11,857,630.

Summary of the Inventive Concept

This inventive concept adapts formulations of SN-38 with poly(amino acid) block polymers for specific, high-need markets, including disaster relief, high-security storage, emergency medical response, remote environments, and high-security facilities.

Background and Problem Solved

The original patent disclosed formulations of SN-38 with poly(amino acid) copolymers, but these formulations were not tailored to address the unique challenges of niche applications. The inventive concept addresses this limitation by adapting the formulations for extreme weather conditions, high-security needs, and other specialized environments.

Detailed Description of the Inventive Concept

The inventive concept comprises a system, method, kit, or formulation of SN-38 with a poly(amino acid) block copolymer, adapted for specific niche applications. For example, the formulation may be designed for extreme weather conditions, such as high temperatures, humidity, or wind, making it suitable for disaster relief efforts. Alternatively, the composition may be stored in a tamper-evident container for high-security storage or packaged in a portable, waterproof container for emergency medical response. The formulation may also be adapted for use in remote, high-altitude environments or administered via a secure, tamper-evident delivery device in high-security facilities.

Novelty and Inventive Step

The new claims introduce novel and non-obvious adaptations of the original formulations to address specific niche applications, including disaster relief, high-security storage, emergency medical response, remote environments, and high-security facilities. These adaptations provide a unique combination of features that distinguish the inventive concept from the original patent.

Alternative Embodiments and Variations

Other embodiments of the inventive concept could include adaptations for other niche applications, such as search and rescue operations, environmental remediation, or space exploration. The poly(amino acid) block copolymer could be modified to incorporate additional functional groups or modified to improve its stability or solubility in different environments.

Potential Commercial Applications and Market

The inventive concept has significant commercial potential in various industries, including pharmaceuticals, biotechnology, disaster relief, emergency medical services, and high-security facilities. The market for these specialized formulations is substantial, driven by the growing need for tailored solutions in niche applications.

CPC Classifications

SectionClassGroup
A A61 A61K47/34
A A61 A61K9/08
A A61 A61K9/19
A A61 A61K31/4375
A A61 A61K31/513
A A61 A61K31/519
A A61 A61K45/06
A A61 A61K47/26

Field of Art

Pharmaceutical formulations, specifically chemotherapeutic drug delivery systems involving SN-38 and poly(amino acid) block copolymers, with expertise in drug stability, specialized packaging, and targeted delivery mechanisms

Person of Ordinary Skill (PHOSITA) Profile

A pharmaceutical formulation scientist with advanced degree in chemistry or pharmaceutical sciences, experienced in drug delivery technologies, polymer chemistry, and medical packaging design, familiar with camptothecin derivatives and polymer-based drug stabilization techniques

Obviousness Rationale

A PHOSITA would recognize that adapting the SN-38 formulation for specialized environments represents a predictable variation of the source patent's core technology. The fundamental chemical composition remains consistent, with modifications primarily addressing packaging, storage, and delivery constraints. These adaptations represent routine engineering solutions within the established framework of the original patent's drug delivery system.

Obvious Combinations & Variations

Source Patent Element
Composition of SN-38 with poly(amino acid) block copolymer
PTD Variation
Formulation adapted for extreme weather conditions in disaster relief scenarios
Obviousness Reasoning
Modifying polymer composition for environmental stability is a known technique in drug delivery, representing a predictable design choice for a PHOSITA seeking to extend drug utility
Source Patent Element
Percentage ranges of SN-38 and copolymer in original composition
PTD Variation
Specialized packaging in tamper-evident and waterproof containers
Obviousness Reasoning
Container design modifications are routine engineering adaptations that do not fundamentally alter the chemical composition, representing an obvious extension of the original formulation
Source Patent Element
Base formulation of SN-38 with poly(amino acid) block copolymer
PTD Variation
Adaptation for high-altitude or remote environment deployment
Obviousness Reasoning
Adjusting polymer properties for environmental resilience is a standard approach in pharmaceutical formulation, utilizing known techniques for maintaining drug stability
Source Patent Element
Chemotherapeutic composition for cancer treatment
PTD Variation
Secure delivery mechanisms for high-security medical facilities
Obviousness Reasoning
Developing specialized delivery systems represents an obvious design variation that addresses practical implementation challenges without introducing novel chemical principles
35 U.S.C. § 103 Summary: Pursuant to 35 U.S.C. ยง 103, the variations disclosed in this publication would be considered obvious to a person having ordinary skill in the art at the time of invention, when viewed in light of US Patent 11857630. The disclosed adaptations represent predictable extensions of the source patent's fundamental chemical composition and delivery methodology, employing routine engineering solutions that would be apparent to a skilled practitioner in pharmaceutical formulation technologies.

Original Patent Information

Patent NumberUS 11,857,630
TitleFormulations of SN-38 with poly(amino acid) block polymers
Assignee(s)TYNDALL FORMULATION SERVICES, LLC