United States Patent 8,137,993: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 8,137,993, titled "Methods of identifying responders to dopamine agonist therapy and treating metabolic conditions thereof," is a significant patent that addresses the identification and treatment of patients with metabolic conditions using dopamine agonist therapy. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent, filed on March 25, 2004, and granted on March 20, 2012, is part of a larger body of research focused on metabolic conditions such as Type 2 diabetes, pre-diabetes, Metabolic Syndrome, obesity, and related disorders. The invention involves methods for identifying patients who are likely to respond to dopamine agonist therapy and administering this therapy to treat various metabolic conditions.
Scope of the Invention
Metabolic Conditions
The patent targets a range of metabolic conditions, including:
- Type 2 diabetes
- Pre-diabetes
- Metabolic Syndrome
- Obesity
- Hyperglycemia
- Glucose intolerance
- Hyperinsulinemia
- Insulin resistance
- Elevated plasma lipid levels[1].
Dopamine Agonist Therapy
Dopamine agonists are drugs that mimic the action of dopamine, a neurotransmitter involved in various physiological processes. The patent outlines methods for using these agonists to treat the aforementioned metabolic conditions by modulating dopamine pathways.
Claims of the Patent
Key Claims
The patent includes several key claims that define the scope of the invention:
- Claim 1: A method of identifying patients to be treated by dopamine agonist therapy, involving the analysis of plasma or serum samples for specific biomarkers.
- Claim 2: Administering a pharmaceutically effective regimen of dopamine agonist therapy to the identified patients.
- Claim 3: The metabolic condition being treated is selected from a group consisting of Type 2 diabetes, pre-diabetes, Metabolic Syndrome, obesity, and other related conditions[1].
Claim Construction
The claims are constructed to provide clear notice of what is claimed, as required by patent law. They define the scope of protection afforded by the patent and distinguish the invention from prior art. The specification and prosecution history of the patent are crucial in understanding the claims and their scope[2].
Methodology
Biomarker Analysis
The method involves analyzing plasma or serum samples for specific biomarkers to identify patients who are likely responders to dopamine agonist therapy. This analysis is critical in personalizing treatment and ensuring that only those who will benefit from the therapy are treated[1].
Administration of Therapy
Once patients are identified, the patent outlines the administration of a pharmaceutically effective regimen of dopamine agonist therapy. This involves dosing and treatment protocols tailored to the specific metabolic condition being treated.
Patent Landscape
Related Patents
Several other patents relate to the treatment of metabolic conditions and the use of dopamine agonists:
- U.S. Pat. No. 6,322,976: Discloses methods for diagnosing diseases associated with defects in insulin action, glucose metabolism, and catecholamine action.
- U.S. Pat. No. 6,166,017: Describes the medical treatment of diabetes mellitus type II and counteracting risk factors of Metabolic Syndrome using ketoconazole.
- U.S. Pat. No. 6,040,292: Outlines methods for treating diabetes mellitus, including type I and type II, using rhIGF-I/IGFBP-3 complex[1].
Patent Classification
The patent is classified under various categories, including:
- G01N33/50: Chemical analysis of biological material, e.g., blood, urine.
- G01N33/6893: Immunological testing involving proteins, peptides, or amino acids related to diseases.
- G01N33/9413: Neurotransmitters, specifically dopamine[1].
Practical Applications
Personalized Medicine
The patent's focus on identifying responders to dopamine agonist therapy aligns with the growing field of personalized medicine. By analyzing biomarkers, healthcare providers can tailor treatments to individual patients, enhancing efficacy and reducing side effects.
Clinical Implications
The use of dopamine agonists in treating metabolic conditions has significant clinical implications. It offers a new therapeutic approach for patients who may not respond well to traditional treatments, such as insulin or other metabolic drugs.
Challenges and Limitations
Claim Indefiniteness
Patent claims must be precise enough to afford clear notice of what is claimed. However, the complexity of biological systems and the variability in patient responses can sometimes lead to challenges in defining the scope of the claims with absolute precision[2].
Regulatory Considerations
The development and approval of new therapeutic agents, including dopamine agonists, are subject to stringent regulatory requirements. Ensuring compliance with these regulations is crucial for bringing these treatments to market.
Future Directions
Patent Analytics
Advanced patent analytics can help in understanding the patent landscape and identifying gaps or opportunities in intellectual property protection. Tools like Claim Coverage Matrix and ClaimScape® software can categorize patents by claims and scope concepts, facilitating a more efficient analysis of large numbers of patent claims[3].
Small Claims Patent Court
There is ongoing discussion about the feasibility of a small claims patent court, which could streamline the process of resolving patent disputes, especially for smaller entities. This could impact the enforcement and protection of patents like US 8,137,993[5].
Key Takeaways
- Identification of Responders: The patent provides a method for identifying patients who are likely to respond to dopamine agonist therapy.
- Metabolic Conditions: The therapy targets a range of metabolic conditions, including Type 2 diabetes and Metabolic Syndrome.
- Biomarker Analysis: Plasma or serum samples are analyzed for specific biomarkers to personalize treatment.
- Regulatory Compliance: Ensuring precision in claims and compliance with regulatory requirements is crucial.
- Future Directions: Advanced patent analytics and potential changes in patent dispute resolution mechanisms could impact the protection and enforcement of this patent.
FAQs
Q: What is the primary focus of United States Patent 8,137,993?
A: The primary focus is on methods for identifying patients who will respond to dopamine agonist therapy and treating various metabolic conditions using this therapy.
Q: Which metabolic conditions are targeted by this patent?
A: The patent targets conditions such as Type 2 diabetes, pre-diabetes, Metabolic Syndrome, obesity, hyperglycemia, glucose intolerance, hyperinsulinemia, insulin resistance, and elevated plasma lipid levels.
Q: How are patients identified for dopamine agonist therapy?
A: Patients are identified through the analysis of plasma or serum samples for specific biomarkers.
Q: What are the implications of this patent for personalized medicine?
A: The patent aligns with personalized medicine by allowing healthcare providers to tailor treatments to individual patients based on biomarker analysis.
Q: What are some of the challenges in enforcing this patent?
A: Challenges include ensuring the precision of claims to avoid indefiniteness and complying with regulatory requirements for therapeutic agents.
Sources
- US8137993B2 - Methods of identifying responders to dopamine agonist therapy and treating metabolic conditions thereof - Google Patents
- UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT - Nature Simulation Systems Inc. v. Autodesk, Inc.
- Patent Analytics | Intellectual Property Law - Schwegman Lundberg & Woessner, P.A.
- Research and Course Guides: Patent Searching, Advanced: Overview - Clemson University Libraries
- U.S. Patent Small Claims Court - Administrative Conference of the United States
