United States Patent 10,117,951: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,117,951, titled "Sulfoalkyl ether cyclodextrin compositions," is a patent that covers specific chemical compositions and their applications. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, granted on October 30, 2018, pertains to sulfoalkyl ether cyclodextrin compositions, which are used in various formulations, methods, and systems. These compositions are particularly relevant in pharmaceutical and chemical applications[4].
Scope of the Patent
Technical Field
The patent falls within the technical field of chemical compositions, specifically focusing on sulfoalkyl ether cyclodextrins. These compounds are derivatives of cyclodextrins, which are cyclic oligosaccharides with a hydrophobic interior and a hydrophilic exterior. The sulfoalkylation process modifies these cyclodextrins to enhance their solubility and interaction with other molecules[4].
Practical Applications
The compositions described in the patent can be employed in various applications, including pharmaceutical formulations, drug delivery systems, and other chemical processes. For instance, they can improve the solubility and bioavailability of poorly soluble drugs, making them more effective in therapeutic treatments[4].
Claims of the Patent
Claim Structure
The patent includes multiple claims that define the scope of the invention. These claims can be broadly categorized into:
Independent Claims
Independent claims define the core aspects of the invention without reference to other claims. For example, Claim 1 might describe the general composition of the sulfoalkyl ether cyclodextrin, including the specific chemical structure and the process of its preparation[4].
Dependent Claims
Dependent claims build upon the independent claims, providing additional details or specific embodiments of the invention. These claims might specify particular methods of use, additional components in the composition, or specific applications of the sulfoalkyl ether cyclodextrins[4].
Key Claim Elements
- Chemical Composition: The claims specify the chemical structure of the sulfoalkyl ether cyclodextrins, including the type and degree of sulfoalkylation.
- Preparation Methods: The patent describes the methods for preparing these compositions, which may involve specific reaction conditions and reagents.
- Applications: Claims may also cover various applications, such as pharmaceutical formulations, drug delivery systems, and other chemical processes[4].
Patent Landscape
Related Patents and Prior Art
The patent landscape for sulfoalkyl ether cyclodextrin compositions includes a range of prior art and related patents. For example, earlier patents like U.S. Pat. Nos. 5,134,127, which also deal with cyclodextrin compositions, provide a foundation for the current invention. These prior patents often describe different modifications to cyclodextrins and their applications, which the current patent builds upon[4].
Competitive Environment
The competitive environment for patents related to cyclodextrin compositions is active, with multiple companies and researchers developing new derivatives and applications. This competition drives innovation, as seen in the continuous improvement in the solubility, stability, and bioavailability of these compounds[4].
Patent Scope Metrics
Independent Claim Length and Count
Research on patent scope metrics, such as independent claim length and count, can provide insights into the breadth and specificity of the patent. Generally, narrower claims with fewer elements are more likely to be granted and have a shorter examination process compared to broader claims[3].
Examination Process
The examination process for this patent, like others, would have involved evaluating the claims for novelty, non-obviousness, and utility. The patent office would have assessed whether the claims integrate the abstract idea (if any) into a practical application, as required by the subject matter eligibility analysis under 35 U.S.C. ยง 101[1].
Practical Implications and Real-World Impact
Pharmaceutical Applications
The sulfoalkyl ether cyclodextrin compositions have significant implications for pharmaceutical applications. By enhancing the solubility and bioavailability of drugs, these compositions can improve the efficacy and safety of therapeutic treatments. This is particularly important for drugs that are poorly soluble in water, as it can lead to better patient outcomes[4].
Regulatory Considerations
The patent's claims and scope must comply with regulatory requirements, such as those outlined in the FDA Orange Book. This ensures that any pharmaceutical products developed using these compositions meet the necessary standards for safety and efficacy[5].
Challenges and Strategies in Patent Prosecution
Overcoming Section 101 Rejections
When facing section 101 rejections, it is crucial to demonstrate that the claims are directed to a specific, concrete technological advancement or solution to a technical problem. This involves showing that the claims reflect an improvement in the functioning of a computer or another technology or technical field, as emphasized in the 2024 Guidance Update[1].
Understanding the Examiner's Perspective
Understanding how the assigned patent examiner applies the subject matter eligibility analysis is vital. Different examiners may have varying interpretations of the framework, so it is important to tailor the arguments to the specific examiner's perspective and to highlight the practical utility and real-world impact of the invention[1].
Key Takeaways
- Specific Chemical Composition: The patent covers specific sulfoalkyl ether cyclodextrin compositions with defined chemical structures.
- Broad Applications: These compositions have various applications, including pharmaceutical formulations and drug delivery systems.
- Regulatory Compliance: The patent must comply with regulatory requirements, such as those outlined in the FDA Orange Book.
- Patent Scope Metrics: The patent's scope is defined by metrics such as independent claim length and count, which influence the examination process.
- Practical Implications: The compositions can significantly improve the solubility and bioavailability of drugs, leading to better therapeutic outcomes.
FAQs
What are sulfoalkyl ether cyclodextrins?
Sulfoalkyl ether cyclodextrins are derivatives of cyclodextrins that have been modified through sulfoalkylation to enhance their solubility and interaction with other molecules.
What are the primary applications of the compositions described in US Patent 10,117,951?
The primary applications include pharmaceutical formulations, drug delivery systems, and other chemical processes where improved solubility and bioavailability are crucial.
How does the patent comply with regulatory requirements?
The patent's claims and scope must comply with regulatory requirements, such as those outlined in the FDA Orange Book, to ensure safety and efficacy of pharmaceutical products developed using these compositions.
What challenges might arise during the patent prosecution process for similar inventions?
Challenges might include overcoming section 101 rejections by demonstrating practical applicability and understanding the specific perspective of the assigned patent examiner.
How do patent scope metrics influence the examination process?
Patent scope metrics, such as independent claim length and count, can influence the examination process by affecting the likelihood of grant and the duration of the examination. Narrower claims are generally more likely to be granted and have a shorter examination process.
Sources
- The Importance of Prong Two of Step 2A for AI Inventions - Baker Botts
- Patent Claims Research Dataset - USPTO
- Patent Claims and Patent Scope - SSRN
- US10117951B2 - Sulfoalkyl ether cyclodextrin compositions - Google Patents
- US Patent 10117951 - PharmaCompass
