Adaptive Drive Assembly for Specialized Drug Delivery Systems
Legal Citation
Summary of the Inventive Concept
The inventive concept adapts the original drive assembly for drug delivery systems to cater to specific, niche markets and operational environments, including high-security, disaster relief, extreme weather, remote locations, and high-altitude settings.
Background and Problem Solved
The original patent disclosed a drive assembly for drug delivery systems, but it lacked the adaptability to cater to unique operational environments. This inventive concept addresses the limitations of the original patent by providing specialized variations of the drive assembly to meet the specific demands of these niche markets.
Detailed Description of the Inventive Concept
The inventive concept comprises a drive assembly with a plunger member and a biasing member, which can be adapted for various operational environments. In a high-security environment, the plunger member includes a tamper-evident feature to prevent unauthorized access. For disaster relief scenarios, the biasing member is configured to withstand extreme environmental conditions. In extreme weather conditions, the drive assembly is adapted to operate within a specific temperature range. For remote or isolated locations, the drive assembly is powered by a renewable energy source. In high-altitude environments, the drive assembly is adapted to operate above 10,000 feet.
Novelty and Inventive Step
The inventive concept's novelty lies in its adaptability to cater to specific operational environments, which is not addressed by the original patent. The inventive step is the incorporation of specialized features and adaptations to meet the unique demands of these niche markets.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include adapting the drive assembly for use in other specialized environments, such as space exploration or underwater operations. Variations could include different materials, geometries, or actuation mechanisms to further optimize the drive assembly for specific applications.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in various industries, including pharmaceuticals, disaster relief, and remote healthcare. The target markets include high-security facilities, disaster relief organizations, and remote or isolated communities.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Medical device engineering, specifically drug delivery systems and injection device mechanisms, focusing on mechanical drive assemblies for fluid transfer and patient-use interfaces
Person of Ordinary Skill (PHOSITA) Profile
A mechanical engineer with expertise in medical device design, familiar with drug delivery system architectures, mechanical actuation principles, and environmental adaptation strategies for medical devices
Obviousness Rationale
A PHOSITA would recognize that the source patent's fundamental drive assembly design provides a flexible framework for environmental adaptations. The core mechanical principles of plunger movement, biasing mechanisms, and injection system components remain consistent across the disclosed variations. The proposed modifications represent predictable engineering solutions to extend the device's operational envelope using standard design techniques.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,769 |
|---|---|
| Title | Drive assembly and spacer for drug delivery system |
| Assignee(s) | Becton, Dickinson and Company |