United States Patent 11,166,963: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,166,963, titled "Natural combination hormone replacement formulations and therapies," is a significant patent in the field of pharmaceuticals, particularly focusing on hormone replacement therapies. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Details
- Publication Number: US11166963B2
- Authority: United States
- Prior Art Date: The patent application was filed on August 24, 2017[5].
Invention Description
The patent describes natural combination hormone replacement formulations and therapies, specifically focusing on estrogen and progesterone replacement. The formulations include solubilized estradiol and progesterone, which are crucial for hormone replacement therapies. These formulations are designed to improve the bioavailability and stability of the hormones, making them more effective for therapeutic use[5].
Scope of the Patent
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
- Claim 1: A pharmaceutical composition comprising a solubilized estradiol and a solubilizing agent.
- Claim 2: The composition of claim 1, further comprising progesterone.
- Claim 3: The composition of claim 2, wherein the solubilizing agent is selected from the group consisting of diglycerides, triacylglycerols, and glyceride groups[5].
These claims are critical in defining what aspects of the invention are protected under the patent.
Prior Art Keywords
The patent lists several prior art keywords, including estradiol, progesterone, solubilizing agents, pharmaceutical compositions, and specific chemical compounds like octanoic acid and decanoic acid. These keywords help in understanding the context and the existing knowledge in the field that the patent builds upon[5].
Claims Analysis
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims (e.g., Claim 1) stand alone and define the invention broadly, while dependent claims (e.g., Claim 2) build upon the independent claims and provide additional specificity.
Claim Dependency
The dependency between claims is crucial for understanding the hierarchical structure of the patent. For instance, Claim 2 depends on Claim 1, meaning that the composition described in Claim 2 must include the elements of Claim 1 plus additional components like progesterone[5].
Patent Landscape
Related Patents and Applications
The patent landscape for hormone replacement therapies is extensive and includes numerous patents and applications. For example, TherapeuticsMD, the assignee of this patent, has several other patents related to hormone replacement therapies, such as those for BIJUVA® and IMVEXXY®[2].
International Patent Offices
To understand the global patent landscape, it is essential to search international patent offices. Databases like the European Patent Office's esp@cenet, the Japan Patent Office, and the World Intellectual Property Organization's PATENTSCOPE provide access to international patent applications and granted patents, which can reveal similar or overlapping inventions[1].
Common Citation Document (CCD)
The Common Citation Document (CCD) application can be used to consolidate prior art cited by multiple patent offices for the same invention. This tool helps in identifying potential prior art that may be relevant to the patent in question[1].
Search and Analysis Tools
Patent Public Search
The USPTO's Patent Public Search tool is a powerful resource for searching prior art and related patents. This tool replaced legacy search tools like PubEast and PubWest and provides enhanced access to prior art[1].
Global Dossier
The Global Dossier service allows users to access the file histories of related applications from participating IP offices. This service is useful for understanding the patent family and the status of related applications globally[1].
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents and applications. This dataset can be used to analyze the scope and trends of patent claims, including those related to hormone replacement therapies[3].
Legal and Regulatory Aspects
Enablement Requirement
The enablement requirement is a critical aspect of patent law, ensuring that the patent disclosure is sufficient to enable a person of ordinary skill in the art to make and use the invention. Recent guidelines from the USPTO emphasize the importance of consistent analysis of this requirement[4].
Virtual Patent Marking
The patent satisfies the virtual patent-marking provisions of various jurisdictions, including the America Invents Act. This is important for providing public notice of the patents that protect the products and services[2].
Key Takeaways
- Patent Scope: The patent protects specific formulations of hormone replacement therapies, including solubilized estradiol and progesterone.
- Claims Structure: The patent includes independent and dependent claims that define the invention and its variations.
- Patent Landscape: The landscape includes numerous related patents and applications, both domestically and internationally.
- Search Tools: Utilizing tools like Patent Public Search, Global Dossier, and the Patent Claims Research Dataset is essential for thorough analysis.
- Legal Aspects: Compliance with legal requirements such as enablement and virtual patent marking is crucial.
FAQs
Q: What is the main focus of United States Patent 11,166,963?
A: The main focus is on natural combination hormone replacement formulations and therapies, specifically involving solubilized estradiol and progesterone.
Q: How can I search for related patents and applications?
A: You can use tools like the USPTO's Patent Public Search, Global Dossier, and international patent office databases such as esp@cenet and PATENTSCOPE.
Q: What is the significance of the Common Citation Document (CCD)?
A: The CCD consolidates prior art cited by multiple patent offices for the same invention, helping to identify relevant prior art.
Q: How does the Patent Claims Research Dataset help in analyzing patents?
A: It provides detailed information on claims from U.S. patents and applications, enabling analysis of patent scope and trends.
Q: Why is virtual patent marking important?
A: It provides public notice of the patents that protect products and services, satisfying legal requirements such as those under the America Invents Act.
Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- TherapeuticsMD - Product Patents. Retrieved from https://www.therapeuticsmd.com/patents.php
- USPTO - Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Federal Register - Guidelines for Assessing Enablement in Utility Applications and .... Retrieved from https://unblock.federalregister.gov
- Google Patents - Natural combination hormone replacement formulations and therapies. Retrieved from https://patents.google.com/patent/US11166963B2/en
