United States Patent RE43834: A Detailed Analysis of Scope and Claims
Introduction
United States Patent RE43834, titled "Injection Device," is a reissue patent that outlines a sophisticated injection mechanism designed for precise and user-friendly medication administration. This analysis will delve into the key aspects of the patent, including its scope, claims, and the broader patent landscape.
Background and Purpose
The patent RE43834 is focused on an injection device that is designed to improve the accuracy and ease of use in administering medication. This device is particularly relevant in the healthcare sector, where precise dosing and user-friendly interfaces are crucial.
Scope of the Patent
The scope of the patent encompasses a detailed description of an injection mechanism that includes several innovative features:
Key Components
- Piston Rod and Non-Rotatable Part: The mechanism involves a piston rod that moves axially in a distal direction to expel medication, without rotating, unless an axial force is applied. This is achieved through the screwed engagement of the thread on the piston rod with the internal thread of the non-rotatable part[1].
Dose Setting and Scale Drum
- Dose Scale Drum: The device includes a dose scale drum that is threadedly engaged with a second thread element fixed to the housing. This allows the dose scale drum to rotate and indicate the set dose size, visible through a window. The drum can be rotated to reduce a wrongly set dose without injecting medication[1].
Injection Mechanism
- Axial Force and Rotation: When an axial force is applied to press the injection button, it transforms into rotational movement of the piston rod, causing it to advance distally and expel the medication. The tube moves axially without rotating during injection[1].
Claims of the Patent
The patent includes several claims that define the specific features and functionalities of the injection device:
Primary Claims
- Claim 19: Describes the injection mechanism with a piston rod that advances distally to expel medication due to the screwed engagement with the non-rotatable part[1].
Dependent Claims
- Claim 20: Adds the feature of a dose scale drum that is threadedly engaged with a second thread element, allowing rotational movement to indicate the dose size[1].
- Claim 21: Specifies that the tube is prevented from rotating relative to the housing during injection, and the dose scale rotates to a zero position during injection[1].
- Claim 22: Details that the dose scale drum is journalled on the tube and the tube is locked against rotations during an injection[1].
Additional Features
- Claim 24: Includes a first button for setting a dose and a second button for receiving the force necessary to drive the medication from the cartridge[1].
- Claim 26: Describes an injection button that receives the force necessary to drive the medication from the cartridge during injection[1].
Patent Landscape
The patent landscape surrounding RE43834 involves several key aspects:
Reissue Patents
- Reissue patents like RE43834 are granted to correct defects in the original patent or to make changes that do not enlarge the scope of the claims. This process ensures that the patent remains valid and enforceable[4].
Patent Eligibility and Validity
- The validity of patent claims is subject to scrutiny under 35 U.S.C. § 101 and § 112. Claims must be definite and particularly point out and distinctly claim the subject matter of the invention. The Supreme Court has established that claims directed to abstract ideas, laws of nature, and natural phenomena are not patent-eligible unless they integrate these concepts into something more[2].
Data and Research
- The USPTO's Patent Claims Research Dataset provides insights into patent claims and their scope. This dataset can be used to analyze trends and statistics related to patent claims, including those in the medical device sector[3].
Industry Impact
The injection device described in RE43834 has significant implications for the healthcare industry:
User-Friendly Design
- The device's design ensures that users can easily set and adjust doses without injecting medication, enhancing safety and usability[1].
Precision and Accuracy
- The mechanism's ability to prevent the tube from rotating during injection and to indicate the dose size accurately is crucial for precise medication administration[1].
Legal and Regulatory Considerations
The patent is subject to various legal and regulatory considerations:
Terminal Disclaimers
- The USPTO has the authority to impose conditions on terminal disclaimers, ensuring that claims are not rendered invalid if a parent patent claim is found invalid. This is consistent with statutory and case law[4].
Patent Infringement and Validity
- Cases like Rain Gutter Pros, LLC v. MGP Manufacturing, LLC highlight the importance of patent infringement and validity disputes. These cases often involve detailed analyses of patent claims and their scope[5].
Key Takeaways
- Innovative Mechanism: The patent describes an innovative injection mechanism with features like a non-rotating piston rod and a dose scale drum.
- User-Friendly: The device is designed for ease of use, allowing users to set and adjust doses accurately.
- Regulatory Compliance: The patent adheres to regulatory standards, ensuring that claims are definite and valid.
- Industry Impact: The device has significant implications for the healthcare industry, enhancing safety and precision in medication administration.
Frequently Asked Questions (FAQs)
Q: What is the primary innovation in the injection device described in RE43834?
A: The primary innovation is the mechanism that allows the piston rod to advance distally without rotating, ensuring precise medication administration.
Q: How does the dose scale drum function in this device?
A: The dose scale drum is threadedly engaged with a second thread element, allowing it to rotate and indicate the set dose size, visible through a window.
Q: What is the significance of the non-rotatable part in the injection mechanism?
A: The non-rotatable part ensures that the piston rod advances distally to expel medication only when an axial force is applied, preventing unwanted rotation.
Q: How does the device prevent the tube from rotating during injection?
A: The tube is locked against rotations during an injection, ensuring that it moves axially without rotating.
Q: What are the implications of this patent for the healthcare industry?
A: The patent has significant implications for enhancing safety, precision, and user-friendliness in medication administration.
Cited Sources
- Drug Patent Watch: Summary for Patent: RE43834.
- Court of Appeals for the Federal Circuit: Berkheimer v. HP Inc.
- USPTO: Patent Claims Research Dataset.
- Regulations.gov: Letterhead DC Office.
- Casetext: Rain Gutter Pros, LLC v. MGP Manufacturing, LLC.
