Details for Patent: 11,969,439

Which drugs does patent 11,969,439 protect, and when does it expire?

Patent 11,969,439 protects ELCYS and is included in one NDA.

Summary for Patent: 11,969,439

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 O2 that 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):	John Maloney, Aruna Koganti, Phanesh Koneru
Assignee:	Exela Pharma Sciences LLC
Application Number:	US18/520,172
Patent Claim Types: see list of patent claims

Understanding the Scope and Claims of a U.S. Patent: A Detailed Analysis

Introduction to U.S. Patents

U.S. patents are granted by the U.S. Patent and Trademark Office (USPTO) to inventors who create new and useful processes, machines, manufactures, or compositions of matter, or any new and useful improvement thereof. The patent application process is governed by Title 35 of the U.S. Code and involves several key components, including the claims, which define the scope of the patent's protection[2].

The Importance of Claims in a Patent Application

Claims are the most critical part of any patent application. They define what the inventor considers to be their invention and set the boundaries of the patent's protection. The claims must be clear, concise, and supported by the specification and drawings included in the patent application. If the claims are too broad or indefinite, they may be rejected by the patent examiner[2][3].

Analyzing the Scope of Patent 11,969,439

To analyze the scope and claims of a specific patent, such as U.S. Patent 11,969,439, one must delve into the patent's documentation.

Patent Claims

• Independent and Dependent Claims: The patent will include both independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims.
• Claim Construction: The interpretation of these claims is a question of law and is subject to de novo review on appeal. This means that the courts will interpret the claims without deference to the lower court's decision[5].

Specification and Drawings

• The specification provides a detailed description of the invention, including how it is made and used. This section must support the claims and ensure that they are not indefinite.
• Drawings, if included, help to illustrate the invention and must be referred to in the specification[2].

Patent Landscape Analysis

Prior Art Search

Before analyzing a specific patent, it is crucial to conduct a prior art search to determine if the invention has already been patented or described in a publication. This search can be performed using the USPTO's patent database or the Patent Public Search tool[2].

Claim Coverage Matrix

A Claim Coverage Matrix can be used to determine which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist. This involves categorizing patents by claims and overarching scope concepts, which helps in filtering, searching, and analyzing large numbers of patent claims concurrently[3].

Competitor Patents

Analyzing competitor patents is essential to understand the broader patent landscape. This involves identifying similar patents, their claims, and the scope of their protection. Tools like Schwegman’s ClaimScape® software can generate interactive claim charts to help in this analysis[3].

Patent Prosecution and Maintenance

Patent Examination

After filing a patent application, a patent examiner reviews the application to ensure compliance with legal requirements. This includes a prior art search to determine if the claimed invention is useful, novel, and non-obvious. If the examiner finds issues, an Office Action is issued, and the applicant must respond to address these concerns[2].

Post-Grant Procedures

If a patent is granted, it is presumed valid under 35 U.S.C. § 282. However, the patent can still be challenged through post-grant procedures such as inter partes review or post-grant review. Maintaining the patent involves paying issue fees and potentially filing for continued examination or appealing decisions to the Patent Trial and Appeal Board[2][5].

Data Sources for Patent Analysis

PatentsView Database

The PatentsView database, created from USPTO public bulk data releases, provides comprehensive data sets for patent analysis. This includes disambiguated inventor and assignee data, international patent classification, and non-patent citations, among other information. These data sets can be bulk downloaded and used for detailed analysis of patent landscapes[1].

USPTO Resources

The USPTO offers various resources, including the patent database and the Patent Public Search tool, which are essential for conducting prior art searches and analyzing patent claims. Additionally, the USPTO Scientific and Technical Information Center provides access to scientific and technical journals that can aid in patent research[2].

Key Takeaways

• Claims Define Protection: The claims in a patent application are crucial as they define the scope of the patent's protection.
• Prior Art Search: Conducting a thorough prior art search is essential to ensure the novelty and non-obviousness of the invention.
• Patent Landscape Analysis: Analyzing the broader patent landscape using tools like Claim Coverage Matrices and interactive claim charts helps in identifying gaps and opportunities.
• Post-Grant Procedures: Patents can be challenged post-grant, and maintaining them involves ongoing fees and potential legal actions.
• Data Sources: Utilizing databases like PatentsView and USPTO resources is vital for comprehensive patent analysis.

FAQs

1. What is the role of claims in a patent application?

   • Claims define the scope of the patent's protection and must be clear, concise, and supported by the specification and drawings.

2. How do you conduct a prior art search for a patent?

   • A prior art search can be conducted using the USPTO's patent database or the Patent Public Search tool to determine if the invention has already been patented or described in a publication.

3. What is a Claim Coverage Matrix?

   • A Claim Coverage Matrix categorizes patents by claims and overarching scope concepts to help in filtering, searching, and analyzing large numbers of patent claims concurrently.

4. What happens during patent prosecution?

   • During patent prosecution, a patent examiner reviews the application to ensure compliance with legal requirements, including a prior art search to determine if the claimed invention is useful, novel, and non-obvious.

5. How can you maintain a granted patent?

   • Maintaining a granted patent involves paying issue fees and potentially filing for continued examination or appealing decisions to the Patent Trial and Appeal Board.

Sources

1. PatentsView - Data Download Tables - PatentsView
2. The Maryland People's Law Library - Patents
3. Schwegman, Lundberg & Woessner, P.A. - Patent Analytics
4. National Archives - Records of the Patent and Trademark Office
5. United States Court of Appeals for the Federal Circuit - VASCULAR SOLUTIONS LLC v. MEDTRONIC, INC.

Drugs Protected by US Patent 11,969,439

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						METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION