Details for Patent: 11,510,941

Which drugs does patent 11,510,941 protect, and when does it expire?

Patent 11,510,941 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 11,510,941

Title:	Stable, highly pure L-cysteine compositions for injection and methods of use
Abstract:	The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cystine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace Othat is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use.
Inventor(s):	Maloney John, Koganti Aruna, Koneru Phanesh
Assignee:	EXELA PHARMA SCIENCES, LLC
Application Number:	US17164263
Patent Claim Types: see list of patent claims

Understanding the Scope and Claims of United States Patent 11,510,941: A Detailed Analysis

Introduction

Patent 11,510,941, like any other patent, is a complex document that outlines the scope, claims, and innovations of a specific invention. To analyze this patent, it is crucial to delve into its key components, the broader patent landscape, and the recent updates in patent law, particularly those related to artificial intelligence (AI) and software technologies.

The Role of the USPTO

The United States Patent and Trademark Office (USPTO) is the agency responsible for granting U.S. patents and registering trademarks. The USPTO plays a critical role in ensuring that patents meet the criteria for subject matter eligibility, novelty, non-obviousness, and utility[2].

Recent USPTO Guidance on AI Patents

The 2024 USPTO guidance update on AI patents is particularly relevant when analyzing patents involving AI and software technologies. This update, prompted by Executive Order 14110, aims to refine and clarify the process for determining the patent eligibility of AI-related inventions. Key takeaways include:

• Integration into Practical Applications: The guidance emphasizes the importance of evaluating whether a claim integrates a judicial exception into a practical application. This involves assessing additional elements in the claim to determine if they impose meaningful limits on the exception, transforming the claim into patent-eligible subject matter[1].
• AI-Assisted Inventions: The update clarifies that the method of invention development, including the use of AI, does not impact subject matter eligibility. Instead, the focus remains on the claimed invention itself, ensuring that AI-assisted inventions are evaluated on equal footing with other technologies[1].
• Recent Case Law: The guidance incorporates recent Federal Circuit decisions, providing up-to-date legal standards and interpretations relevant for AI inventions. This integration promotes consistency and clarity in the application of patent eligibility criteria[1].

Patent Claims and Scope

Patent claims are the heart of any patent, defining the scope of the invention and what is protected. Here are some key points to consider:

• Claim Structure: Claims must be carefully crafted to meet the criteria for patent eligibility. This includes ensuring that the claims integrate abstract ideas into practical applications, providing concrete technological improvements[1].
• Examples from USPTO Guidance: The USPTO has provided new examples (Examples 47-49) specifically tailored to AI technologies. For instance, Example 48 illustrates how claims involving specific applications of AI, such as improving the accuracy of voice commands in a hands-free environment, can meet the eligibility criteria by demonstrating a practical application[1].

Analyzing Patent 11,510,941

To analyze the scope and claims of Patent 11,510,941, one must:

• Review Claim Language: Examine the language of each claim to determine if it integrates abstract ideas into practical applications. Ensure that the claims specify how the invention provides concrete benefits or solves specific problems in the relevant field.
• Check for Meaningful Limits: Verify that the claims impose meaningful limits on any judicial exceptions, transforming the abstract idea into a patent-eligible invention.
• Consider Real-World Applications: Highlight the real-world applications of the claimed method or system. Demonstrating how the invention is applied in a way that provides practical utility is crucial for patent eligibility[1].

Patent Landscape and Search Tools

Understanding the broader patent landscape is essential for innovators and patent practitioners. Here are some tools and resources that can aid in this analysis:

• Patent Public Search: The USPTO's Patent Public Search tool allows users to search for existing patents and published patent applications. This tool provides enhanced access to prior art and can help in identifying similar inventions[4].
• Global Dossier: This service provides access to the file histories of related applications from participating IP Offices, helping users to see the patent family for a specific application and identify potential overlaps or prior art[4].
• Patent Claims Research Dataset: This dataset, provided by the USPTO, contains detailed information on claims from U.S. patents and patent applications. It can be used to analyze trends and patterns in patent claims, which can inform the drafting of new claims[3].

Implications for Innovators and Practitioners

The analysis of Patent 11,510,941 and the broader patent landscape has several implications:

• Drafting Claims: Practitioners should draft claims that integrate abstract ideas into practical applications, ensuring that the claims provide meaningful limits on judicial exceptions. This approach helps in avoiding section 101 rejections common in software-related patent applications[1].
• Evaluating Patentability: Innovators must evaluate the patentability of their inventions by assessing whether the claimed invention offers a concrete technological improvement. This involves demonstrating how the invention solves specific problems in the relevant field[1].

Key Takeaways

• Practical Applications: Ensure that claims integrate abstract ideas into practical applications to meet patent eligibility criteria.
• AI-Assisted Inventions: The method of invention development, including AI, does not impact subject matter eligibility; focus on the claimed invention itself.
• Recent Case Law: Incorporate recent Federal Circuit decisions to ensure consistency and clarity in patent eligibility criteria.
• Real-World Applications: Highlight the real-world applications of the claimed method or system to demonstrate practical utility.

FAQs

Q: How does the 2024 USPTO guidance update affect AI-related patent applications?

A: The update clarifies that AI-assisted inventions are evaluated on equal footing with other technologies, focusing on the claimed invention itself rather than the method of development. It also provides new examples and integrates recent case law to ensure consistency in patent eligibility criteria[1].

Q: What are the key elements to consider when drafting patent claims for AI inventions?

A: Key elements include integrating abstract ideas into practical applications, ensuring that claims impose meaningful limits on judicial exceptions, and highlighting real-world applications that provide concrete benefits[1].

Q: How can the USPTO's Patent Public Search tool aid in patent analysis?

A: The Patent Public Search tool allows users to search for existing patents and published patent applications, providing enhanced access to prior art and helping to identify similar inventions[4].

Q: What is the significance of the Global Dossier service in patent analysis?

A: The Global Dossier service provides access to the file histories of related applications from participating IP Offices, enabling users to see the patent family for a specific application and identify potential overlaps or prior art[4].

Q: How can the Patent Claims Research Dataset be used in analyzing patent trends?

A: The dataset contains detailed information on claims from U.S. patents and patent applications, allowing users to analyze trends and patterns in patent claims, which can inform the drafting of new claims[3].

Sources

1. Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz
2. U.S. Patent and Trademark Office (USPTO) | USAGov
3. Patent Claims Research Dataset - USPTO
4. Search for patents - USPTO

Drugs Protected by US Patent 11,510,941

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660-001	Apr 16, 2019		RX	Yes	Yes	11,510,941		Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	11,510,941		Y