Analyzing the Scope and Claims of United States Patent 6,432,440: Pectin Compositions and Methods of Use
Introduction
United States Patent 6,432,440, titled "Pectin compositions and methods of use for improved delivery of drugs to mucosal surfaces," presents a significant innovation in the field of pharmaceutical delivery systems. This patent, issued to address the challenges of drug delivery to mucosal surfaces, is a crucial piece of intellectual property that warrants a detailed analysis of its scope, claims, and the broader patent landscape.
Background and Context
The patent focuses on the development of pectin-based compositions for the delivery of therapeutic agents to mucosal surfaces. Pectin, a natural polysaccharide found in the cell walls of fruits, has been utilized for its gelling properties and biocompatibility. The invention aims to provide a single-component nasal delivery system that forms a gel upon application, enhancing the retention and efficacy of therapeutic agents at the site of administration[4].
Scope of the Patent
Composition and Ingredients
The patent describes a pharmaceutical composition that includes pectin with a low degree of esterification (DE), typically less than 50% or preferably less than 35%. This composition also includes a therapeutic agent and is formulated in an aqueous carrier. The absence of divalent metal ions, which can interfere with the gelling process, is a key aspect of the invention. The composition is designed to gel upon application to the mucosal surface, providing a retaining effect that prolongs the action of the therapeutic agent[4].
Application and Delivery
The patent outlines methods for the application of these compositions, particularly for nasal administration. The therapeutic agents can include drugs for treating conditions such as rhinitis, viral infections, and decongestants. The gelling property of the composition ensures that the therapeutic agent is retained at the mucosal surface for a longer period, enhancing its local action and reducing systemic absorption[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention:
- Claim 1 describes the composition comprising pectin with a low DE, a therapeutic agent, and an aqueous carrier, which forms a gel upon application to a mucosal surface.
- Claim 2 specifies the method of application, where the composition is applied to the mucosal surface without an extraneous source of divalent metal ions.
- Claim 3 details the therapeutic agents that can be used, including those for nasal administration[4].
Dependent Claims
Dependent claims further elaborate on the independent claims by specifying additional details such as:
- The degree of esterification of the pectin.
- The absence of divalent metal ions.
- The types of therapeutic agents and their applications.
- The method of preparing the composition and its application[4].
Patent Landscape
Prior Art and Related Patents
The patent references prior art, including U.S. Pat. No. 5,147,648, which describes a pharmaceutical formulation made from two components that form a gel upon application. However, the current patent distinguishes itself by using a single-component system and emphasizing the use of pectin with a low DE[4].
Global Dossier and IP5 Offices
The patent is part of a broader global patent family, which can be accessed through the Global Dossier service provided by the USPTO. This service allows users to view the file histories of related applications from participating IP Offices, including the IP5 Offices (USPTO, EPO, JPO, KIPO, and SIPO)[1].
Common Citation Document (CCD)
The CCD application consolidates prior art cited by all participating offices for the family members of a patent application, providing a single point of access to up-to-date citation data. This is particularly useful for understanding the global patent landscape and the relevance of prior art to the current patent[1].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full scope of protection provided by this patent, a Claim Coverage Matrix can be used. This matrix categorizes patents by claims and scope concepts, helping to identify which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist. For example, using Schwegman’s ClaimScape® software, interactive claim charts can be generated to review patent coverage with technical experts and management[3].
Scope Concepts and Claim Charts
The scope concepts of the patent claims, such as the use of pectin with a low DE and the absence of divalent metal ions, are critical in determining the value of the patent claims. These concepts can be categorized as high, medium, or low value, depending on their current and future relevance to the company’s products and technologies[3].
Practical Applications and Future Directions
Therapeutic Agents and Mucosal Delivery
The patent's focus on mucosal delivery systems, particularly for nasal administration, opens up significant opportunities for the treatment of various conditions. The composition's ability to retain therapeutic agents at the site of application for a longer period enhances their efficacy and reduces systemic side effects[4].
Pharmaceutical Formulations and Innovations
The use of pectin in pharmaceutical formulations is a growing area of research. Future innovations could involve exploring different types of pectin, varying degrees of esterification, and combining pectin with other polymers to enhance the gelling properties and drug delivery capabilities[4].
Key Takeaways
- Composition and Ingredients: The patent involves a pectin-based composition with a low DE, a therapeutic agent, and an aqueous carrier.
- Application and Delivery: The composition is designed for nasal administration and forms a gel upon application, enhancing the retention and efficacy of the therapeutic agent.
- Claims and Scope: The patent includes independent and dependent claims that define the scope of the invention, including the degree of esterification and the absence of divalent metal ions.
- Patent Landscape: The patent is part of a global patent family and can be analyzed using tools like the Global Dossier and CCD.
- Practical Applications: The patent has significant practical applications in mucosal delivery systems, particularly for nasal administration.
FAQs
Q: What is the primary innovation of United States Patent 6,432,440?
A: The primary innovation is the development of a single-component pectin-based composition for the delivery of therapeutic agents to mucosal surfaces, which forms a gel upon application.
Q: What is the significance of using pectin with a low degree of esterification (DE)?
A: Using pectin with a low DE ensures that the composition gels effectively upon application to the mucosal surface, enhancing the retention and efficacy of the therapeutic agent.
Q: How does the composition differ from prior art?
A: The composition differs from prior art by using a single-component system and emphasizing the use of pectin with a low DE, unlike two-component systems described in prior patents.
Q: What tools can be used to analyze the patent landscape of this invention?
A: Tools such as the Global Dossier, Common Citation Document (CCD), and patent analytics software like ClaimScape® can be used to analyze the patent landscape.
Q: What are the potential future directions for this technology?
A: Future directions could involve exploring different types of pectin, varying degrees of esterification, and combining pectin with other polymers to enhance the gelling properties and drug delivery capabilities.
Sources
- USPTO, "Search for patents - USPTO," October 18, 2018.
- ACUS, "U.S. Patent Small Claims Court," April 28, 2022.
- SLWIP, "Patent Analytics | Intellectual Property Law."
- Google Patents, "US6432440B1 - Pectin compositions and methods of use for improved delivery of drugs to mucosal surfaces."
