Understanding the Scope and Claims of United States Patent 10,240,152
Introduction
United States Patent 10,240,152, titled "Compositions and methods for inhibiting expression of transthyretin," is a patent that delves into the realm of genetic therapy, specifically targeting the transthyretin (TTR) gene. This analysis will break down the key components of the patent, including its scope, claims, and the broader patent landscape it operates within.
Background of the Patent
The patent, assigned to a specific entity (though not specified in the provided sources), involves the use of double-stranded ribonucleic acid (dsRNA) to inhibit the expression of the TTR gene. Transthyretin is a protein associated with various diseases, including amyloidosis, a condition where abnormal proteins accumulate in organs and tissues.
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific inventions and methods that are protected.
Claims Overview
The patent includes multiple claims that can be categorized into several types:
- Composition Claims: These claims cover the specific dsRNA compositions designed to target the TTR gene. For example, claims might specify the sequence of the dsRNA, its structure, and any pharmaceutical compositions that include this dsRNA[4].
- Method Claims: These claims describe the methods of using the dsRNA to inhibit TTR gene expression. This could include administration methods, dosages, and treatment protocols[4].
Specific Claim Examples
- Claim 1 might specify a dsRNA molecule having a particular sequence that targets the TTR gene.
- Claim 2 could describe a pharmaceutical composition comprising the dsRNA molecule and a carrier.
- Claim 3 might outline a method for administering the dsRNA to a patient to inhibit TTR expression.
Patent Claims Analysis
To understand the patent's claims fully, it is essential to analyze each claim's language and scope.
Claim Language
The language used in the claims is critical. It must be precise enough to define the invention clearly but broad enough to cover variations that might arise in the future. For instance, the claims might use terms like "comprising" or "consisting of" to define the composition of the dsRNA and any associated pharmaceutical formulations[4].
Claim Dependencies
Claims can be independent or dependent. Independent claims stand alone and define the invention broadly, while dependent claims build upon independent claims and add additional limitations. This structure helps in ensuring that the patent covers a range of variations while maintaining specificity[4].
Patent Landscape
The patent landscape for genetic therapies, particularly those targeting specific genes like TTR, is complex and evolving.
Competing Patents
Other patents may exist that target similar genetic mechanisms or use different approaches to inhibit TTR expression. These patents could be from different companies or research institutions, and understanding their scope and claims is crucial for avoiding infringement and identifying potential collaborations or licensing opportunities[3].
Regulatory Environment
The regulatory environment plays a significant role in the patent landscape. For example, the USPTO's guidelines and the Federal Circuit's rulings on patentability and claim scope can significantly impact how patents are granted and enforced. The case of In Re FLOAT'N'GRILL LLC highlights the importance of adhering to statutory limitations, such as the "original patent" requirement for reissue claims[5].
Economic and Research Implications
The economic and research implications of this patent are substantial.
Research Dataset
The USPTO's Patent Claims Research Dataset can provide insights into the trends and scope of patent claims in the biotechnology sector. This dataset includes detailed information on claims from US patents and applications, which can help in understanding the broader context of genetic therapy patents[3].
Market Impact
Patents like US 10,240,152 can have a significant market impact by providing exclusive rights to the patent holder, allowing them to develop and market treatments without competition for a specified period. This can drive innovation but also raises concerns about access to treatments and the potential for patent thickets that hinder further research[1].
Legal Considerations
Legal considerations are paramount when analyzing a patent's scope and claims.
Statutory Requirements
The patent must meet statutory requirements such as novelty, non-obviousness, and utility. The claims must also be definite and enabled, meaning they must clearly describe the invention and provide enough information for one skilled in the art to replicate it[5].
Reissue and Continuation Procedures
The patent landscape is also influenced by procedures like reissue and continuation applications. These procedures allow patent holders to adjust their claims or file additional applications based on the original patent, but they are subject to specific legal limitations, such as the "original patent" requirement for reissue claims[5].
Expert Insights and Statistics
Industry experts and statistical data can provide valuable context.
Expert Opinions
Experts in the field of genetic therapy and patent law can offer insights into the patent's significance and potential impact. For example, Alan Marco, former Chief Economist for the USPTO, has contributed to research on patent scope and claims, which can be relevant in understanding the broader implications of such patents[3].
Statistical Trends
Statistical trends from the USPTO's datasets can show how patents in the biotechnology sector are evolving. For instance, the Patent Claims Research Dataset reveals trends in claim scope and complexity, which can help in predicting future developments in genetic therapy patents[3].
Key Takeaways
- Specific Claims: The patent includes specific claims for dsRNA compositions and methods targeting the TTR gene.
- Patent Landscape: The patent operates within a complex landscape of genetic therapy patents, with competing patents and regulatory considerations.
- Economic Impact: The patent can have significant economic implications, including market exclusivity and potential barriers to further research.
- Legal Considerations: The patent must meet statutory requirements, and any adjustments through reissue or continuation procedures are subject to legal limitations.
FAQs
Q: What is the primary focus of United States Patent 10,240,152?
A: The primary focus is on compositions and methods for inhibiting the expression of the transthyretin (TTR) gene using double-stranded ribonucleic acid (dsRNA).
Q: What types of claims are included in the patent?
A: The patent includes composition claims for the dsRNA and method claims for its use in inhibiting TTR expression.
Q: How does the patent landscape affect this patent?
A: The patent landscape includes competing patents, regulatory guidelines, and legal precedents that can impact its scope and enforcement.
Q: What are the economic implications of this patent?
A: The patent can provide market exclusivity, drive innovation, but also potentially create barriers to further research due to patent thickets.
Q: What are the key legal considerations for this patent?
A: The patent must meet statutory requirements such as novelty, non-obviousness, and utility, and any reissue or continuation procedures must adhere to specific legal limitations.
Cited Sources
- Carley, M., & Hegde, D. (n.d.). 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
- Administrative Conference of the United States. (n.d.). U.S. Patent Small Claims Court. Retrieved from https://www.acus.gov/research-projects/us-patent-small-claims-court
- United States Patent and Trademark Office. (n.d.). Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents. (n.d.). US10240152B2 - Compositions and methods for inhibiting expression of transthyretin. Retrieved from https://patents.google.com/patent/US10240152B2/en
- Court of Appeals for the Federal Circuit. (2023). In Re FLOAT'N'GRILL LLC. Retrieved from https://cafc.uscourts.gov/opinions-orders/22-1438.OPINION.7-12-2023_2156183.pdf
