Understanding the Scope and Claims of United States Patent 11,224,598
Introduction
United States Patent 11,224,598, titled "Methods of increasing lacrimal proteins," is a patent that addresses treatments for dry eye disease. To delve into the specifics of this patent, it is crucial to analyze its scope, claims, and the broader patent landscape in which it exists.
Patent Structure and Components
A patent, including US 11,224,598, typically consists of several key sections that define the invention and its boundaries.
Abstract and Summary
The abstract and summary provide a concise overview of the invention. For US 11,224,598, these sections would outline the methods and pharmaceutical formulations designed to increase lacrimal proteins, thereby treating dry eye disease[1].
Detailed Description
This section provides a comprehensive explanation of the invention, including how it works, the materials used, and any specific processes involved. For this patent, the detailed description would elaborate on the methods of increasing lacrimal proteins, possibly including the role of nicotinic acetylcholine receptor agonists and other relevant compounds[1].
Drawings and Figures
Drawings and figures are included to visually illustrate the invention. While the patent text does not specify the exact content of these visuals, they would likely depict the molecular structures of the compounds, the administration methods, or any other relevant graphical representations.
Claims
The claims section is the most critical part of a patent as it defines the legal boundaries of the invention. The claims in US 11,224,598 would specify exactly what is being patented, such as the use of particular compounds to increase lacrimal proteins, the methods of administration, and any other specific aspects of the treatment[1].
Scope of the Claims
The scope of the claims in a patent determines the extent of the patent owner's rights. For US 11,224,598, the claims would need to be clear and specific enough to enable any person skilled in the relevant field to make and use the invention.
Broad vs. Narrow Claims
Patent claims can be broad or narrow. Broad claims capture a wider range of embodiments but risk being invalidated if they are not supported by the written description. Narrow claims, on the other hand, are more specific but can be easily designed around by competitors. The balance between broad and narrow claims is crucial, especially in the pharmaceutical and biotechnology industries where genus claims (claims that cover a class of compounds) are common[3].
Written Description Requirement
The written description requirement, as outlined in 35 U.S.C. ยง 112(a), mandates that the specification must adequately describe the invention in "such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same." For US 11,224,598, this means that the patent must provide sufficient detail about the methods and compounds used to increase lacrimal proteins so that others in the field can replicate the invention[3][5].
Enablement Requirement
The enablement requirement ensures that the patent specification provides enough information to enable a person skilled in the art to make and use the invention without undue experimentation. For pharmaceutical inventions like those in US 11,224,598, this can be particularly challenging, as it may require testing multiple species within a genus to determine which ones are effective[3].
Prior Art and Novelty
The patent must also be novel and non-obvious over the prior art. This means that the methods and compounds described in US 11,224,598 must not have been previously disclosed or obvious to someone skilled in the field. The patent application process involves a thorough search of prior art to ensure that the invention meets these criteria[4].
Patent Landscape
Pharmaceutical and Biotechnology Industry
In the pharmaceutical and biotechnology industries, patents play a critical role in protecting intellectual property. The scope of patent claims in these industries is often broader to capture a range of compounds and methods, but this must be balanced against the need for specificity and enablement. The recent jurisprudence on genus claims has made it more challenging to obtain valuable patent protection in these fields[3].
International Considerations
While there is no such thing as an "international patent," patents are territorial, meaning they must be filed and granted in each country where protection is sought. This adds complexity to the patent landscape, especially for global pharmaceutical companies[2].
Timeline and Costs
The process of obtaining a patent, including for US 11,224,598, involves significant time and cost. The timeline for patent examination can vary by technology area, with pharmaceutical patents often taking longer due to the complexity of the subject matter. Expedited examination options, such as the Track One Prioritized Examination, can reduce this time but at a higher cost[4].
Key Takeaways
- Claims Definition: The claims in US 11,224,598 define the legal boundaries of the invention, specifying the methods and compounds used to increase lacrimal proteins.
- Written Description and Enablement: The patent must provide a clear and enabling description to allow others to make and use the invention.
- Prior Art and Novelty: The invention must be novel and non-obvious over prior art.
- Industry Challenges: The pharmaceutical and biotechnology industries face unique challenges in balancing broad claims with specificity and enablement.
- Global Considerations: Patents are territorial, requiring separate filings in each country.
FAQs
Q: What is the primary focus of US Patent 11,224,598?
A: The primary focus is on methods and pharmaceutical formulations for increasing lacrimal proteins to treat dry eye disease.
Q: Why are the claims section of a patent so important?
A: The claims section defines the legal boundaries of the invention, specifying exactly what is being patented.
Q: What is the written description requirement in patent law?
A: The written description requirement mandates that the patent specification must adequately describe the invention in sufficient detail to enable others to make and use it.
Q: How long does the patent examination process typically take?
A: The timeline varies by technology area, but for pharmaceutical patents, it can take several years, with expedited options available to reduce this time.
Q: Are there international patents?
A: No, there is no such thing as an "international patent"; patents must be filed and granted in each country where protection is sought.
Sources
- US11224598B2 - Methods of increasing lacrimal proteins - Google Patents
- FAQ: Intellectual Property/Patents/Tech Transfer - University of Michigan
- Eviscerating Patent Scope - DigitalCommons@NYLS
- TIMELINE AND COSTS FOR PATENT FILINGS - SBIR
- Patent Law: A Handbook for Congress - CRS Reports
