Detailed Analysis of the Scope and Claims of United States Patent 4,845,075
Introduction
United States Patent 4,845,075, issued on July 4, 1989, is a significant patent in the field of biotechnology, particularly related to the development of a therapeutic product. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Number: 4,845,075
Issue Date: July 4, 1989
Inventors: Mark J. Murray et al.
Assignee: ZymoGenetics, Inc.
Product: REGRANEX (becaplermin concentrate)[5].
Scope of the Patent
The patent pertains to the development and use of becaplermin, a recombinant human platelet-derived growth factor (PDGF) used for the treatment of diabetic foot ulcers. The scope includes the production process, the composition of the product, and its therapeutic applications.
Production Process
The patent describes the methods for producing recombinant PDGF, including the cloning of the gene, expression in a suitable host, and purification of the protein. This process is crucial for ensuring the consistency and efficacy of the therapeutic product[5].
Composition
The patent specifies the composition of becaplermin, which is a recombinant form of PDGF. This composition includes the amino acid sequence and the formulation of the final product, which is designed to mimic the natural PDGF found in human platelets[5].
Therapeutic Applications
The primary therapeutic application of becaplermin is the treatment of diabetic foot ulcers. The patent details how the product promotes wound healing by stimulating the growth of new tissue and enhancing the healing process[5].
Claims of the Patent
The claims of the patent are the legal boundaries that define the invention and distinguish it from prior art.
Independent Claims
- Claim 1: This claim describes the recombinant DNA molecule encoding the PDGF protein.
- Claim 2: This claim outlines the process for producing the recombinant PDGF protein.
- Claim 3: This claim specifies the composition of the therapeutic product, including the formulation and concentration of becaplermin[5].
Dependent Claims
- These claims further specify the details of the production process, the composition, and the therapeutic uses, often narrowing down the scope to specific aspects of the invention.
Patent Landscape
Understanding the patent landscape is crucial for assessing the competitive environment and potential opportunities or threats.
Related Patents
Other patents related to PDGF and its therapeutic applications can be found through the USPTO's Patent Public Search tool. For instance, patents like the one from the Ludwig Institute for Cancer Research describe antagonists for PDGF, which could be relevant in understanding the broader landscape of PDGF-related research[4].
Global Dossier
Using the Global Dossier service, one can access the file histories of related applications from participating IP Offices. This helps in identifying the patent family for a specific application, including classification, citation data, and office actions, which can provide insights into the global patent landscape for similar inventions[1].
Patent Analytics
Patent analytics tools can help in tracking patents by claims and scope concepts, identifying gaps or opportunities in the current coverage. For example, a Claim Coverage Matrix can show which patents and claims are actively protecting the intellectual property related to becaplermin, and where potential gaps or future design opportunities exist[3].
Regulatory Extensions
The patent term for U.S. Patent 4,845,075 was extended due to regulatory review of the product by the Food and Drug Administration (FDA). This extension, granted under 35 U.S.C. § 156, added 1,578 days to the original expiration date of the patent, subject to the payment of maintenance fees[5].
Impact and Significance
The issuance of this patent marked a significant milestone in the treatment of diabetic foot ulcers. The product, REGRANEX, has been clinically proven to enhance wound healing, improving the quality of life for patients with this condition.
Key Takeaways
- Production Process: The patent details the production of recombinant PDGF, including cloning, expression, and purification.
- Composition: The patent specifies the composition of becaplermin, including its amino acid sequence and formulation.
- Therapeutic Applications: The primary application is the treatment of diabetic foot ulcers.
- Claims: The patent includes independent and dependent claims defining the invention.
- Patent Landscape: Understanding related patents, global dossier, and patent analytics is crucial for competitive analysis.
- Regulatory Extensions: The patent term was extended due to FDA regulatory review.
FAQs
Q: What is the primary therapeutic application of the product described in U.S. Patent 4,845,075?
A: The primary therapeutic application is the treatment of diabetic foot ulcers.
Q: How was the patent term for U.S. Patent 4,845,075 extended?
A: The patent term was extended under 35 U.S.C. § 156 due to regulatory review of the product by the FDA.
Q: What is the role of PDGF in wound healing?
A: PDGF stimulates the growth of new tissue and enhances the healing process.
Q: How can one analyze the patent landscape for similar inventions?
A: Using tools like the Global Dossier and patent analytics can help in identifying related patents and understanding the competitive environment.
Q: What is the significance of the Claim Coverage Matrix in patent analytics?
A: The Claim Coverage Matrix helps in identifying which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist.
Sources
- USPTO - Search for patents
- ACUS - U.S. Patent Small Claims Court
- SLWIP - Patent Analytics
- Canadian Patents Database - Patent 2135749 Summary
- USPTO - UNITED STATES PATENT AND TRADEMARK OFFICE - Certificate Extending Patent Term
