Next-Generation Tissue Kallikrein 1 Delivery Systems for Personalized Ischemic Condition Treatment

Publication ID: 24-11857608_0005_PTD
Published: October 28, 2025
Category:Future Evolutions & Paradigm Shifts

Legal Citation

pr1or.art Inc., “Next-Generation Tissue Kallikrein 1 Delivery Systems for Personalized Ischemic Condition Treatment,” Published Technical Disclosure No. 24-11857608_0005_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857608_0005_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

The present inventive concept envisions a paradigm shift in tissue kallikrein 1 delivery systems, leveraging advancements in wearable technology, machine learning, and sustained-release formulations to provide personalized, real-time treatment of ischemic conditions.

Background and Problem Solved

The original patent disclosed dosage forms of tissue kallikrein 1 for treating ischemic conditions, but had limitations in terms of dosing regimens, patient variability, and lack of real-time monitoring. The present inventive concept addresses these limitations by introducing wearable devices, machine learning algorithms, and sustained-release formulations to provide more effective and personalized treatment options.

Detailed Description of the Inventive Concept

The new inventive concept comprises a wearable device with a transdermal patch containing a dosage form of tissue kallikrein 1, which is configured to monitor the subject's vital signs and adjust the dosage form delivery in real-time based on the monitored vital signs. Additionally, a machine learning algorithm is used to predict optimal dosage forms and delivery schedules for individual subjects, utilizing genomic data and medical history to generate a customized treatment plan. Furthermore, a sustained-release dosage form of tissue kallikrein 1 is designed to maintain a therapeutically-effective serum level for at least 7 days after a single administration, reducing the need for frequent dosing. A device for transdermal delivery of tissue kallikrein 1, comprising a micro-needle array and a reservoir containing the dosage form, is also disclosed. Finally, a system for remote monitoring and management of ischemic conditions, comprising a mobile application that receives data from the wearable device and transmits alerts and treatment recommendations to healthcare providers and caregivers, is envisioned.

Novelty and Inventive Step

The new claims introduce a wearable device with real-time monitoring and adjustment capabilities, machine learning algorithms for personalized treatment, and sustained-release formulations, which are not present in the original patent. These features provide a significant improvement over the original patent, enabling more effective and personalized treatment of ischemic conditions.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include different wearable device designs, varying machine learning algorithms, and diverse sustained-release formulations. Additionally, the inventive concept could be adapted for use in other therapeutic areas, such as cancer treatment or inflammatory disorders.

Potential Commercial Applications and Market

The present inventive concept has significant commercial potential in the pharmaceutical and medical device industries, with potential applications in ischemic condition treatment, personalized medicine, and remote patient monitoring. The target market includes pharmaceutical companies, medical device manufacturers, and healthcare providers seeking to improve treatment outcomes and reduce healthcare costs.

CPC Classifications

SectionClassGroup
A A61 A61K38/4853
A A61 A61K9/0019
A A61 A61K45/06
C C12 C12Y304/21035

Field of Art

Pharmaceutical biotechnology, specifically focused on protein-based therapeutic delivery systems for treating ischemic conditions, with expertise in drug formulation, protein engineering, and personalized medicine technologies

Person of Ordinary Skill (PHOSITA) Profile

A skilled practitioner with advanced degrees in biotechnology or pharmaceutical sciences, familiar with protein drug delivery techniques, medical device design, and emerging personalized medicine technologies

Obviousness Rationale

A person having ordinary skill in the art would recognize that the PTD's variations represent predictable extensions of the source patent's core teachings about tissue kallikrein 1 dosage forms. The proposed innovations in delivery technology, such as real-time monitoring and personalized dosing, are logical progressions of existing pharmaceutical and medical device design principles. These variations demonstrate standard problem-solving approaches in personalized therapeutic delivery that would be apparent to a skilled practitioner.

Obvious Combinations & Variations

Source Patent Element
Subcutaneous and intravenous administration of tissue kallikrein 1 dosage forms for treating ischemic conditions
PTD Variation
Transdermal delivery using micro-needle array with real-time monitoring and adjustment capabilities
Obviousness Reasoning
Known micro-needle technologies and continuous monitoring systems make this variation a predictable design optimization for drug delivery, representing a routine engineering solution to improve patient convenience and treatment precision
Source Patent Element
Therapeutic serum levels of KLK1 polypeptides between 1.0 to 5.0 ng/ml
PTD Variation
Sustained-release formulation maintaining therapeutically-effective levels for at least 7 days
Obviousness Reasoning
Extended-release pharmaceutical formulations are a well-established technique in drug delivery, and a PHOSITA would find it obvious to develop sustained-release mechanisms to reduce dosing frequency
Source Patent Element
Method of treating specific ischemic conditions
PTD Variation
Machine learning algorithm for personalized treatment planning using genomic and medical history data
Obviousness Reasoning
Integration of machine learning with medical treatment is a known approach in personalized medicine, representing a standard technological progression for optimizing therapeutic interventions
Source Patent Element
Dosage forms of tissue kallikrein 1 for treating ischemic conditions
PTD Variation
Wearable device with mobile application for remote monitoring and healthcare provider alerts
Obviousness Reasoning
Combining medical devices with digital health monitoring is a predictable technological evolution, utilizing standard communication and sensor technologies
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 obvious and lacking inventive step. The proposed advancements represent predictable combinations of known pharmaceutical delivery techniques, personalized medicine approaches, and digital health monitoring technologies, thereby rendering subsequent claims obvious under 35 U.S.C. Section 103.

Original Patent Information

Patent NumberUS 11,857,608
TitleDosage forms of tissue kallikrein 1
Assignee(s)DiaMedica Inc.