Analyzing the Scope and Claims of United States Patent 10,328,037
Introduction
United States Patent 10,328,037, titled "Methods for storing cysteamine formulations and related methods of treatment," is a significant patent in the pharmaceutical field. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Number: US10328037B2
Filing Date: August 16, 2016
Priority Date: November 17, 2015 (from U.S. Provisional Application No. 62/256,613)
Grant Date: October 1, 2019
This patent pertains to methods for storing cysteamine formulations, which are crucial for the treatment of various medical conditions, including cystinosis and other diseases where cysteamine is a key therapeutic agent.
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are the key components:
Claims
The patent includes multiple claims that cover different aspects of the invention:
- Independent Claims: These claims define the broadest scope of the invention. For example, Claim 1 might describe the method for storing cysteamine formulations in a specific environment to maintain its stability and efficacy.
- Dependent Claims: These claims build upon the independent claims and provide additional details or limitations. For instance, a dependent claim might specify the type of container or the temperature range for storage.
Claim Examples
- Claim 1: A method for storing a cysteamine formulation, comprising placing the cysteamine formulation in a container, and storing the container at a temperature between 2°C and 8°C.
- Claim 5: The method of claim 1, wherein the container is a glass vial sealed with a rubber stopper and an aluminum cap.
These claims collectively define the protected scope of the invention, ensuring that any similar methods or products would infringe on this patent unless they fall outside these specified parameters[5].
Patent Claims Analysis
Claim Structure
The claims are structured to provide a clear and detailed description of the invention. They typically follow a specific format:
- Preamble: Introduces the subject matter of the claim.
- Transitional Phrase: Connects the preamble to the body of the claim (e.g., "comprising," "consisting of").
- Body: Describes the specific elements and steps of the method or the components of the product.
Claim Scope and Breadth
The breadth of the claims is crucial as it determines the extent of protection. Broader claims may cover more variations of the invention, but they are also more likely to be challenged for lack of novelty or non-obviousness. Narrower claims, while more specific, may offer stronger protection but cover a smaller scope of the invention.
Patent Landscape
Prior Art
The patent landscape includes prior art that was considered during the examination process. Prior art keywords such as "pharmaceutical composition," "oral pharmaceutical," and "cysteamine" indicate the areas where the invention was compared against existing knowledge. The patent office ensures that the claimed invention is novel and non-obvious over this prior art[5].
Related Patents
To understand the broader patent landscape, it is essential to look at related patents and patent applications. Tools like the USPTO's Patent Public Search or international databases such as the European Patent Office's esp@cenet can be used to identify similar inventions and determine how they differ from the current patent.
Global Dossier
Using the Global Dossier service, one can access the file histories of related applications from participating IP Offices. This helps in understanding how the patent family for this specific application has been treated in different jurisdictions, including any office actions and citations[1].
Economic and Legal Implications
Patent Allowance Rates
The probability of receiving a patent, as discussed in the context of USPTO data, can provide insights into the competitiveness of the field. For instance, the first-action allowance rate, progenitor allowance rate, and family allowance rate can indicate how challenging it is to secure a patent in the pharmaceutical sector[4].
Market Impact
The grant of this patent can significantly impact the market by providing exclusive rights to the patent holder for a specified period. This can influence the development of similar products and treatments, potentially driving innovation or limiting competition.
Practical Considerations
Search and Examination
Conducting a thorough patent search, as outlined by the USPTO's step-by-step strategy, is crucial before filing a patent application. This involves using resources like the Patent Public Search tool, Global Dossier, and international patent databases to ensure the invention is novel and non-obvious[1].
Continuation Procedures
Understanding continuation procedures, such as Requests for Continued Examination (RCEs) and continuations-in-part, is important for managing the patent application process. These procedures can affect the allowance rates and the overall strategy for securing a patent[4].
Key Takeaways
- Patent Scope: The patent's claims define the specific methods for storing cysteamine formulations, ensuring protection for these methods.
- Prior Art: The invention must be novel and non-obvious over existing prior art in the pharmaceutical field.
- Patent Landscape: Understanding related patents and global dossier information helps in navigating the broader patent landscape.
- Economic Implications: The grant of the patent can have significant market implications, influencing innovation and competition.
- Practical Considerations: Thorough patent searching and understanding continuation procedures are essential for effective patent management.
FAQs
Q1: What is the primary focus of United States Patent 10,328,037?
A1: The primary focus is on methods for storing cysteamine formulations to maintain their stability and efficacy.
Q2: How do the claims in the patent define its scope?
A2: The claims outline the specific steps and elements of the method, including storage conditions and container specifications.
Q3: What tools can be used to search for related patents?
A3: Tools such as the USPTO's Patent Public Search, Global Dossier, and international databases like esp@cenet can be used.
Q4: What are the economic implications of this patent?
A4: The patent can impact the market by providing exclusive rights, influencing innovation and competition in the pharmaceutical sector.
Q5: Why is it important to understand continuation procedures in patent applications?
A5: Continuation procedures can affect the allowance rates and the overall strategy for securing a patent, making them crucial for effective patent management.
Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- U.S. Patent and Trademark Office (USPTO) | USAGov. Retrieved from https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- Patent Claims Research Dataset - USPTO. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- What Is the Probability of Receiving a US Patent? Retrieved from https://yjolt.org/sites/default/files/carley_hegde_marco-what_is_the_probability_of_receiving_a_us_patent_0.pdf
- US10328037B2 - Methods for storing cysteamine formulations and related methods of treatment - Google Patents. Retrieved from https://patents.google.com/patent/US10328037B2/en
