Detailed Analysis of the Scope and Claims of United States Patent RE41956
Introduction
United States Patent RE41956, titled "Dose Setting Limiter," is a reissue patent that addresses a critical aspect of injection devices, particularly those used for administering medications in controlled doses. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Purpose
The patent RE41956E1 pertains to an invention that enhances the functionality of injection devices by incorporating a mechanism to prevent the setting of a dose that exceeds the amount of liquid left in the cartridge. This is crucial for ensuring accurate and safe medication administration[4].
Key Components and Mechanism
The invention involves several key components:
Dose Setting Mechanism
The device includes a dose setting member that is rotated relative to a driver to set the desired dose. This mechanism is designed to prevent the setting of a dose that would deplete the cartridge beyond its capacity[4].
Driver Element and Track
The driver element is equipped with a track that corresponds to the total amount of medicament in the cartridge. A track follower, coupled to the dose setting member, engages this track and advances to a position based on the set dose. This ensures that the dose setting member cannot be rotated beyond the point where the remaining medicament in the cartridge would be insufficient[4].
Injection Process
During the injection process, the dose setting member is rotated back, carrying the driver element with it, which in turn moves the piston rod forward to inject the set dose. This mechanism ensures that the piston rod moves a distance proportional to the set dose, preventing overdosing or underdosing[4].
Claims Analysis
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the dose setting limiter mechanism, including the driver element with a track and the track follower coupled to the dose setting member.
- Claim 2 specifies the engagement of the track follower with the track to limit the dose setting based on the remaining medicament in the cartridge[4].
Dependent Claims
- These claims further detail the specific components and their interactions, such as the rotation of the dose setting member relative to the driver and the movement of the piston rod during injection[4].
Patent Scope and Protection
The scope of the patent is defined by the claims, which are carefully crafted to cover the essential features of the invention while avoiding overly broad language that could lead to invalidation.
Avoiding Overly Broad Claims
Unlike some patent applications where broad claims can lead to invalidation due to abstract idea exceptions or failure to meet the written description requirement, the claims in RE41956 are specific and tied to the embodiments described in the specification. This approach helps in avoiding common pitfalls such as those highlighted in the Alice v. CLS Bank decision[3].
Patent Landscape and Prior Art
The patent landscape for injection devices and dose setting mechanisms is rich with prior art. For instance:
Prior Art References
- The patent references other inventions, such as EP 608 343, which describes a geared dose setting and injection mechanism. However, RE41956E1 introduces a novel limiting mechanism that prevents setting doses beyond the available medicament[4].
Competing Patents
- Other patents, like those related to medication delivery pens with variable increment dose scales (e.g., EP-0702970-B1), also address dose setting but do not include the specific limiting mechanism of RE41956E1[2].
Industry Impact and Applications
The invention has significant implications for the healthcare industry, particularly in the administration of medications that require precise dosing.
Safety and Accuracy
- The dose setting limiter ensures that patients receive accurate doses, reducing the risk of overdosing or underdosing, which can have serious health consequences.
Compliance with Regulations
- The mechanism complies with regulatory requirements for safety and efficacy in medical devices, making it a valuable asset for manufacturers of injection devices.
Maintenance and Fees
The patent, like other US patents, requires the payment of maintenance fees to remain in force. The details of these fees and the patent's status can be found through the USPTO's fee processing system[5].
Conclusion and Key Takeaways
- Specific Claims: The patent's claims are specific and anchored to the embodiments described in the specification, avoiding the risks associated with overly broad claims.
- Novel Mechanism: The dose setting limiter mechanism is novel and addresses a critical need in injection devices.
- Industry Impact: The invention enhances safety and accuracy in medication administration, making it a valuable contribution to the healthcare industry.
- Regulatory Compliance: The mechanism complies with regulatory requirements, ensuring its viability in the market.
- Maintenance: Regular maintenance fees are necessary to keep the patent in force.
Frequently Asked Questions (FAQs)
Q: What is the primary purpose of the dose setting limiter mechanism in US Patent RE41956?
A: The primary purpose is to prevent the setting of a dose that exceeds the amount of liquid left in the cartridge of an injection device.
Q: How does the track follower mechanism work in this patent?
A: The track follower engages with a track on the driver element, advancing to a position based on the set dose, thereby preventing the setting of doses beyond the available medicament.
Q: What are the potential risks of overly broad claims in patent applications?
A: Overly broad claims can lead to invalidation due to abstract idea exceptions or failure to meet the written description requirement, as seen in cases like Alice v. CLS Bank[3].
Q: How does this patent differ from other dose setting mechanisms?
A: This patent introduces a novel limiting mechanism that prevents setting doses beyond the available medicament, distinguishing it from other inventions like EP 608 343[4].
Q: What are the maintenance requirements for this patent?
A: The patent requires the payment of regular maintenance fees to remain in force, details of which can be found through the USPTO's fee processing system[5].
Cited Sources
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Letterhead DC Office - Regulations.gov
- "Our patents reflect important innovative and inventive steps..."
- [PDF] Letterhead DC Office - Regulations.gov
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Medication delivery pen with variable increment dose scale - Patent
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The Importance of Getting the Claim Scope Right in a US Patent Application
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Dose setting limiter - USRE41956E1 - Google Patents
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USPTO Fee Processing - Maintenance Fee Details - Patent
