United States Patent 6,858,576: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 6,858,576, titled "Methods for regulating gastrointestinal motility," is a significant patent that addresses therapeutic and diagnostic methods related to gastrointestinal health. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
The patent, filed on August 31, 1999, and granted on February 22, 2005, is directed towards novel methods for reducing gastric motility and delaying gastric emptying. These methods are crucial for both therapeutic and diagnostic purposes, particularly in managing gastrointestinal disorders and facilitating diagnostic procedures like radiological examinations or magnetic resonance imaging (MRI)[1].
Scope of the Invention
The invention encompasses methods for beneficially regulating gastrointestinal motility by administering therapeutically effective amounts of exendins or exendin agonists. Exendins, such as exendin 3 and exendin 4, are peptides that mimic the effects of glucagon-like peptide-1 (GLP-1), which naturally regulates gastric motility and emptying[1].
Therapeutic Applications
The methods described in the patent are particularly useful for subjects suffering from gastrointestinal disorders, including spasms associated with acute diverticulitis, biliary tract disorders, or disorders of the Sphincter of Oddi. By reducing gastric motility and delaying gastric emptying, these methods can provide relief from symptoms and improve diagnostic accuracy during procedures[1].
Diagnostic Applications
The patent also highlights the use of these methods in diagnostic procedures. By slowing gastric emptying, healthcare providers can obtain clearer images during radiological examinations or MRI scans, enhancing the diagnostic process[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1: A method of beneficially regulating gastrointestinal motility in a subject by administering a therapeutically effective amount of an exendin or an exendin agonist.
- Claim 2: The method of claim 1, wherein the exendin is exendin 3 or exendin 4[1].
Dependent Claims
- Claims that specify the use of these methods in subjects undergoing gastrointestinal diagnostic procedures or suffering from specific gastrointestinal disorders.
- Claims that detail the pharmaceutical forms and administration routes of the exendins or exendin agonists[1].
Exendin Agonists and Compounds
The patent defines exendin agonists as compounds that mimic the effects of exendins on gastric motility and emptying. These include analogs or derivatives of exendins, which effectively bind to the receptors at which exendins exert their action. The patent provides specific chemical formulas for these compounds, ensuring a broad yet precise coverage of potential therapeutic agents[1].
Pharmaceutical Acceptable Salts
The invention also includes the use of pharmaceutically acceptable salts of the exendin compounds, which can be derived from organic or inorganic acids. This ensures that the compounds can be used in both free base and salt forms, enhancing their therapeutic applicability[1].
Patent Landscape and Related Patents
The patent landscape surrounding gastrointestinal motility regulation is complex and involves various therapeutic and diagnostic approaches.
Competing Technologies
Other patents and research focus on different mechanisms for regulating gastrointestinal motility, such as the use of other peptides or pharmacological agents. However, the specific use of exendins and exendin agonists as described in US6858576B1 remains unique and targeted[1].
Future Developments
Given the ongoing research in gastrointestinal health, there is a potential for future patents to build upon or diverge from the methods described in US6858576B1. This could include new compounds, delivery methods, or applications in other therapeutic areas.
Legal and Regulatory Considerations
Patents like US6858576B1 must comply with the requirements of the Patent Act, including the eligibility criteria under 35 U.S.C. § 101. This involves ensuring that the invention is a new and useful process, machine, manufacture, or composition of matter, or an improvement thereof[2].
Patent Eligibility
The patent's focus on a specific therapeutic application using naturally occurring peptides (exendins) and their agonists ensures it meets the criteria for patent eligibility. It provides a practical application of a natural phenomenon, which is a key factor in determining patent eligibility under current legal standards[2].
Economic and Practical Impact
The economic impact of this patent is significant, particularly in the pharmaceutical and healthcare sectors. By providing effective methods for regulating gastrointestinal motility, it opens up new therapeutic avenues and improves diagnostic outcomes.
Market Potential
The market potential for drugs based on this patent is substantial, given the prevalence of gastrointestinal disorders and the need for effective diagnostic tools. This patent could lead to the development of new drugs that improve patient outcomes and reduce healthcare costs associated with gastrointestinal issues.
Conclusion
United States Patent 6,858,576 is a pivotal invention in the field of gastrointestinal health, offering novel methods for regulating gastric motility and delaying gastric emptying. The patent's scope, claims, and broader patent landscape highlight its significance in both therapeutic and diagnostic applications.
Key Takeaways
- Therapeutic and Diagnostic Applications: The patent provides methods for reducing gastric motility and delaying gastric emptying, useful in managing gastrointestinal disorders and enhancing diagnostic procedures.
- Exendins and Exendin Agonists: The invention centers around the use of exendins and their agonists, which mimic the natural effects of GLP-1.
- Pharmaceutical Forms: The patent includes the use of free base and salt forms of these compounds, ensuring broad therapeutic applicability.
- Patent Eligibility: The invention meets the criteria for patent eligibility under 35 U.S.C. § 101, providing a practical application of a natural phenomenon.
- Economic Impact: The patent has significant economic and practical implications in the pharmaceutical and healthcare sectors.
FAQs
1. What is the primary focus of United States Patent 6,858,576?
The primary focus is on methods for regulating gastrointestinal motility using exendins and exendin agonists.
2. What are the therapeutic applications of this patent?
The methods are used to manage gastrointestinal disorders such as spasms associated with acute diverticulitis, biliary tract disorders, or disorders of the Sphincter of Oddi.
3. How does this patent improve diagnostic procedures?
By slowing gastric emptying, it enhances the clarity of images during radiological examinations or MRI scans.
4. What are exendin agonists, and how do they work?
Exendin agonists are compounds that mimic the effects of exendins on gastric motility and emptying by binding to the same receptors as exendins.
5. Is this patent still in force?
As of the current date, the patent has expired, but its impact on the development of subsequent therapeutic agents and diagnostic methods remains significant.
Cited Sources
- US6858576B1 - Methods for regulating gastrointestinal motility - Google Patents
- AI VISUALIZE, INC. v. NUANCE COMMUNICATIONS, INC. - CAFC
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- U.S. Patent Small Claims Court - ACUS
