Personalized, Adaptive, and Targeted Ischemic Condition Treatment Platform

Publication ID: 24-11857608_0010_PTD

Published: October 28, 2025

Category:Future Evolutions & Paradigm Shifts

Legal Citation

pr1or.art Inc., “Personalized, Adaptive, and Targeted Ischemic Condition Treatment Platform,” Published Technical Disclosure No. 24-11857608_0010_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857608_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. 11,857,608.

Summary of the Inventive Concept

A next-generation platform for ischemic condition treatment, integrating real-time monitoring, AI-driven personalized dosing, and targeted delivery to revolutionize patient outcomes.

Background and Problem Solved

The original patent disclosed dosage forms of tissue kallikrein 1 for treating ischemic conditions. However, these forms have limitations in terms of efficacy, administration, and patient specificity. The new inventive concept addresses these limitations by introducing a wearable, implantable, or injectable device that continuously monitors and adapts to a subject's KLK1 polypeptide levels, administering a customized dosage form in real-time to maintain optimal therapeutic efficacy.

Detailed Description of the Inventive Concept

The platform comprises a wearable, implantable, or injectable device that continuously monitors a subject's KLK1 polypeptide levels, medical history, and genomic profile. The device is connected to a machine learning algorithm that predicts optimal KLK1 polypeptide dosing regimens for individual subjects. The algorithm integrates real-time biometric data, genomic information, and medical history to generate a customized dosage form. The platform also includes a targeting moiety that selectively binds to ischemic tissue, allowing for targeted delivery and enhanced therapeutic efficacy. Additionally, a microneedle array or electroporation system enables efficient, pain-free delivery of the dosage form, and a sensor monitors KLK1 polypeptide levels and adjusts dosage in real-time.

Novelty and Inventive Step

The new inventive concept introduces a paradigm shift in ischemic condition treatment by integrating real-time monitoring, AI-driven personalized dosing, and targeted delivery. The wearable, implantable, or injectable device, machine learning algorithm, and targeting moiety are novel components that overcome the limitations of the original patent.

Alternative Embodiments and Variations

Alternative embodiments of the platform could include using different types of sensors, machine learning algorithms, or targeting moieties. Variations could also include integrating the platform with existing healthcare systems, using different forms of KLK1 polypeptides, or expanding the platform to treat other diseases.

Potential Commercial Applications and Market

The personalized, adaptive, and targeted ischemic condition treatment platform has significant commercial potential in the pharmaceutical and healthcare industries. The platform could be marketed as a premium product for patients requiring personalized treatment, and could also be integrated into existing healthcare systems to improve patient outcomes and reduce costs.

CPC Classifications

Section	Class	Group
A	A61	A61K38/4853
A	A61	A61K9/0019
A	A61	A61K45/06
C	C12	C12Y304/21035

Section 103 Obviousness Analysis (PHOSITA)

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Field of Art

Pharmaceutical biotechnology, specifically focused on protein-based therapeutic delivery systems for treating ischemic conditions, involving molecular biology, drug formulation, and personalized medicine technologies

Person of Ordinary Skill (PHOSITA) Profile

A skilled practitioner with advanced degrees in biotechnology or pharmaceutical sciences, expertise in protein engineering, drug delivery systems, and machine learning applications in personalized medicine, familiar with emerging technologies in targeted drug delivery and real-time monitoring

Obviousness Rationale

A person having ordinary skill in the art would recognize that the PTD represents a predictable extension of the source patent's KLK1 polypeptide treatment method by integrating known technologies in personalized medicine, sensor systems, and targeted drug delivery. The core therapeutic approach of KLK1 polypeptide administration remains consistent, with the PTD merely applying standard technological augmentations to enhance precision and patient-specific treatment. These modifications represent incremental improvements using well-established techniques in biotechnology and personalized medicine.

Obvious Combinations & Variations

Source Patent Element

Subcutaneous or intravenous administration of KLK1 polypeptides for treating ischemic conditions

PTD Variation

Adding real-time monitoring and AI-driven dosage adjustment using wearable/implantable device

Obviousness Reasoning

Continuous monitoring and adaptive dosing are predictable improvements in personalized medicine, representing a known technique for optimizing therapeutic interventions

Source Patent Element

Treatment of various ischemic conditions using KLK1 polypeptides

PTD Variation

Incorporating genomic profiling and machine learning to predict optimal dosing regimens

Obviousness Reasoning

Integrating patient-specific data for treatment optimization is a standard approach in precision medicine, using well-established computational techniques

Source Patent Element

Systemic administration of KLK1 polypeptides

PTD Variation

Adding targeting moiety for selective ischemic tissue binding

Obviousness Reasoning

Targeted drug delivery is a known strategy in pharmaceutical development to improve therapeutic specificity and reduce systemic side effects

Source Patent Element

Intravenous and subcutaneous administration methods

PTD Variation

Implementing microneedle array and electroporation for alternative delivery mechanisms

Obviousness Reasoning

Alternative drug delivery technologies are well-known in the art, representing predictable variations for improving patient comfort and drug absorption

Source Patent Element

KLK1 polypeptide dosage forms for treating ischemic conditions

PTD Variation

Creating on-demand customized dosage form manufacturing platform

Obviousness Reasoning

Personalized medicine platforms with adaptive manufacturing are emerging standard approaches in biotechnology, representing an obvious technological progression

35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857608 and the disclosed technological variations, a person having ordinary skill in the art would find the claimed innovations in personalized ischemic condition treatment obvious and lacking inventive step. The proposed platform represents a predictable combination of known techniques in targeted drug delivery, real-time monitoring, and personalized medicine, thereby rendering subsequent claims of similar technological approaches unpatentable under 35 U.S.C. § 103.

Original Patent Information

Patent Number	US 11,857,608
Title	Dosage forms of tissue kallikrein 1
Assignee(s)	DiaMedica Inc.