Enhanced Compositions and Methods for Hepatic Disease Treatment
Legal Citation
Summary of the Inventive Concept
Improved pharmaceutical compositions and methods for treating hepatic diseases and disorders, enhancing therapeutic efficacy, stability, and patient compliance.
Background and Problem Solved
The original patent disclosed compositions and methods for treating hepatic disorders, particularly hepatitis C, via toll-like receptor (TLR) ligands. However, the patent's limitations included the need for improved stability, efficacy, and patient compliance. The new inventive concept addresses these limitations by introducing specific buffer systems, optimized formulations, and adapted administration methods.
Detailed Description of the Inventive Concept
The enhanced compositions comprise a TLR ligand that activates at least one or more TLRs or Nod-like receptors (NLRs), and a buffer selected from phosphate, citrate, or acetate, which improves the stability of the composition. The method for treating hepatitis C involves administering a pharmaceutical composition comprising a lysate and/or cell wall extract from a Gram-positive bacterium, which activates at least one or more TLRs or NLRs, and a buffer, to enhance therapeutic efficacy. The system for treating hepatic disorders is adapted for oral administration, improving patient compliance. Additionally, the composition's buffer is present in an optimized amount ranging from 0.1% to 5% by weight, ensuring an optimal therapeutic effect.
Novelty and Inventive Step
The new claims introduce specific buffer systems, optimized formulations, and adapted administration methods, which are not disclosed in the original patent. The inventive step lies in the selection of specific buffers and their optimized amounts, as well as the adaptation of the composition for oral administration, resulting in improved stability, efficacy, and patient compliance.
Alternative Embodiments and Variations
Alternative embodiments may include different buffer systems, such as tris or glycine, or varying the amount of buffer in the composition. Variations may also include using different Gram-positive bacteria or modifying the administration method, such as injectable or topical formulations.
Potential Commercial Applications and Market
The enhanced compositions and methods have significant commercial potential in the treatment of hepatic diseases and disorders, particularly hepatitis C. The target market includes pharmaceutical companies, research institutions, and healthcare providers, with potential applications in the development of new treatments and therapies.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical biotechnology, specifically immunomodulatory compositions for hepatic disease treatment, involving toll-like receptor (TLR) and Nod-like receptor (NLR) activation strategies
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical scientist with expertise in immunology, drug formulation, and biotechnology, holding an advanced degree with 3-5 years of research experience in developing immunomodulatory therapeutic compositions
Obviousness Rationale
A person having ordinary skill in the art would recognize that the PTD's variations represent predictable engineering modifications to the source patent's core composition. The disclosed buffer selections, administration methods, and concentration optimizations are logical extensions of the original hepatic disease treatment approach. These variations demonstrate standard pharmaceutical development techniques that would be apparent to a skilled practitioner seeking to improve therapeutic delivery and efficacy.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,577 |
|---|---|
| Title | Compositions and methods for the treatment of hepatic diseases and disorders |
| Assignee(s) | Labyrinth Holdings, LLC |