Targeted Gastrointestinal Tract Treatment with JAK Inhibitor and Advanced Delivery Systems
Legal Citation
Summary of the Inventive Concept
This inventive concept discloses improved methods and compositions for treating diseases of the gastrointestinal tract using JAK inhibitors, featuring advanced delivery systems that enhance efficacy and reduce systemic exposure.
Background and Problem Solved
The original patent disclosed methods for treating gastrointestinal tract diseases with JAK inhibitors, but it had limitations in terms of systemic exposure and efficacy. The new inventive concept addresses these limitations by introducing advanced delivery systems that target the site of disease, reducing systemic exposure and improving treatment outcomes.
Detailed Description of the Inventive Concept
The inventive concept comprises four key components: (1) a JAK inhibitor, (2) an ingestible device that releases the inhibitor at a specific pH level or temperature, (3) a bioadhesive agent that enhances retention at the site of disease, and (4) a mucoadhesive polymer that increases residence time. Alternatively, the concept can be implemented using a device with a sensor that detects biomarkers of the disease, triggering the release of the JAK inhibitor. The inventive concept can also incorporate prebiotic agents to promote a beneficial gut microbiome, further enhancing treatment efficacy.
Novelty and Inventive Step
The new claims introduce novel and non-obvious features, including the use of advanced delivery systems, bioadhesive agents, and mucoadhesive polymers, which significantly improve the treatment of gastrointestinal tract diseases while reducing systemic exposure. These features are not taught or suggested in the original patent.
Alternative Embodiments and Variations
Other embodiments of the inventive concept could include the use of different types of sensors, biomarkers, or release triggers. The concept could also be adapted for use in different disease indications or with other therapeutic agents.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in the treatment of gastrointestinal tract diseases, including Crohn's disease, ulcerative colitis, and irritable bowel syndrome. The market for such treatments is substantial, with an estimated global value of over $10 billion by 2025.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K9/0009 |
| A | A61 | A61K9/0004 |
| A | A61 | A61K9/0053 |
| A | A61 | A61K31/519 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical drug delivery systems, specifically targeted gastrointestinal tract treatment technologies involving JAK inhibitors and advanced drug delivery mechanisms
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical scientist or biomedical engineer with expertise in drug formulation, targeted delivery systems, and gastrointestinal tract treatment technologies, holding advanced degrees in pharmaceutical sciences or bioengineering with knowledge of controlled release mechanisms and drug targeting strategies
Obviousness Rationale
A person having ordinary skill in the art would recognize that the source patent's JAK inhibitor treatment method naturally invites optimization through advanced delivery technologies. The PTD's variations represent predictable engineering solutions to enhance localized drug delivery and reduce systemic exposure, which are standard design considerations in pharmaceutical development. The proposed modifications leverage well-established pharmaceutical engineering techniques to improve the fundamental treatment approach disclosed in the original patent.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,669 |
|---|---|
| Title | Treatment of a disease of the gastrointestinal tract with a JAK inhibitor and devices |
| Assignee(s) | Biora Therapeutics, Inc. |