Analyzing the Scope and Claims of United States Patent 10,335,549: A Comprehensive Guide
Introduction
United States Patent 10,335,549, titled "Devices, systems and methods for medicament delivery," is a significant patent in the field of medical devices, particularly focusing on auto-injectors. This article will delve into the details of the patent, including its scope, claims, and the broader patent landscape it operates within.
Overview of the Patent
The patent, assigned to a company involved in medical device innovation, describes devices, systems, and methods for delivering medicaments, such as epinephrine (adrenaline), using an auto-injector. The invention aims to improve the usability and safety of auto-injectors, addressing common issues like user confusion and inadvertent actuation[4].
Key Components of the Invention
Housing and Needle Configuration
The auto-injector includes a housing, a needle, an energy storage member, an actuator, a locking member, and a needle guard. The needle is designed to move between a first position (contained within the housing) and a second position (where at least a portion of the needle extends from the housing)[4].
Energy Storage Member and Actuator
The energy storage member has two configurations and produces a force when moving from the first to the second configuration, which is used to move the needle from its first to its second position. The actuator is responsible for triggering this movement[4].
Locking Member and Safety Features
The locking member is coupled to the distal end of the housing and can be moved between two positions. In its first position, it prevents the actuator from moving the energy storage member, thus preventing inadvertent actuation. This design ensures that the auto-injector can only be actuated intentionally[4].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
Independent Claims
- Claim 1 describes the apparatus comprising a housing, a needle, an energy storage member, an actuator, and a locking member.
- Claim 10 outlines the method of moving the actuation lock from a first position to a second position to enable the injection process[4].
Dependent Claims
- Dependent claims further specify the details of the components and their interactions, such as the configuration of the energy storage member and the role of the needle guard[4].
Scope of the Patent
The scope of the patent is defined by the claims and the detailed description provided in the specification. Here are some key aspects:
Novelty and Non-Obviousness
The patent must meet the criteria of novelty and non-obviousness. The unique configuration of the locking member and the actuation mechanism from the distal end distinguishes this invention from prior art, making it novel and non-obvious[4].
Enablement and Written Description
The patent must also meet the enablement and written description requirements. The detailed description and drawings provide sufficient information for a person skilled in the art to make and use the invention[4].
Patent Landscape
Prior Art
The patent landscape includes prior art related to auto-injectors, such as those with locking caps and needle covers. However, the specific design and functionality of the patented invention differentiate it from existing solutions[4].
Classification
The patent is classified under various categories, including A61M5/31—Details, A61M5/315—Pistons; Piston-rods, and A61M5/3159—Dose expelling manners. These classifications help in identifying similar patents and understanding the broader context[4].
Legal and Regulatory Considerations
Patent Validity
The validity of the patent can be challenged based on criteria such as indefiniteness, lack of enablement, or failure to meet the written description requirement. For instance, claims that are too broad or indefinite can be invalidated[2].
Litigation and Enforcement
In the event of infringement, the patent holder can seek legal action. The process involves asserting infringement claims and potentially defending the patent's validity in court. Recent cases, such as Maxell, Ltd. v. Amperex Technology Limited, highlight the importance of clear and distinct claims to avoid indefiniteness issues[2].
Economic and Practical Implications
Market Impact
The invention has significant market implications, particularly in the medical device sector. Improved safety and usability features can increase market share and customer satisfaction.
Licensing and Collaboration
The patent can be licensed to other companies, facilitating collaboration and innovation in the field. This can lead to further improvements and variations of the auto-injector design.
Research and Development
Data and Statistics
Research datasets, such as the Patent Claims Research Dataset provided by the USPTO, can offer insights into patent scope and trends. These datasets can help in understanding the broader patent landscape and identifying areas for further innovation[3].
Global Dossier and International Cooperation
Tools like the Global Dossier and the Common Citation Document (CCD) facilitate international cooperation and harmonization in patent searches and examinations. This can streamline the process of filing and managing patents globally[1].
Conclusion
United States Patent 10,335,549 represents a significant advancement in the field of medicament delivery devices. The detailed analysis of its scope, claims, and the broader patent landscape highlights its novelty, practical implications, and legal considerations.
Key Takeaways
- Innovative Design: The patent introduces a unique auto-injector design with improved safety and usability features.
- Legal Considerations: The patent must meet criteria such as novelty, non-obviousness, enablement, and written description to remain valid.
- Market Impact: The invention has potential to significantly impact the medical device market by enhancing user safety and convenience.
- Global Cooperation: Tools like the Global Dossier and CCD facilitate international cooperation in patent management.
FAQs
Q: What is the main innovation of United States Patent 10,335,549?
A: The main innovation is the design of an auto-injector that can be actuated from the distal end, reducing user confusion and improving safety.
Q: How does the locking member function in the patented invention?
A: The locking member prevents the actuator from moving the energy storage member, thus preventing inadvertent actuation of the auto-injector.
Q: What are the key classifications for this patent?
A: The patent is classified under A61M5/31, A61M5/315, and A61M5/3159, among others.
Q: How can the validity of this patent be challenged?
A: The validity can be challenged based on criteria such as indefiniteness, lack of enablement, or failure to meet the written description requirement.
Q: What tools facilitate international cooperation in patent searches and examinations?
A: Tools like the Global Dossier and the Common Citation Document (CCD) facilitate international cooperation and harmonization in patent searches and examinations.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- MAXELL, LTD. v. AMPEREX TECHNOLOGY LIMITED: https://cafc.uscourts.gov/opinions-orders/23-1194.OPINION.3-6-2024_2281183.pdf
- Patent Claims Research Dataset - USPTO: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- US10335549B2 - Devices, systems and methods for medicament delivery: https://patents.google.com/patent/US10335549B2/en
