United States Patent 8,920,392: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 8,920,392, titled "Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions," is a significant innovation in the field of urology and pharmaceutical packaging. This patent, granted to address specific needs in the treatment of overactive bladders, involves a unique device and method for the administration of oxybutynin.
Background
Overactive bladder (OAB) is a common condition characterized by symptoms such as urgency, frequency, and incontinence. Traditional treatments often involve oral medications, which can have systemic side effects. The invention described in US 8,920,392 aims to provide a localized treatment option using topical oxybutynin compositions.
Patent Overview
Publication Details
- Publication Number: US8920392B2
- Prior Art Date: The patent builds upon earlier innovations in flexible containers and topical compositions[1].
Inventive Concept
The patent describes a method and device for treating overactive bladders using topical oxybutynin compositions. The device is a flexible container, such as a pouch or sachet, designed to store and administer the oxybutynin composition effectively.
Device Structure
Laminate Material
The device is made from a laminate material consisting of multiple layers:
- First Polymer Layer: This layer is in direct contact with the oxybutynin composition and is made from a polymer or copolymer that is substantially inert to the composition. Materials like polyethylene and acrylic-based polymers are suggested[1].
- Adhesive Layer: This layer adheres the first polymer layer to the metal foil layer.
- Metal Foil Layer: This layer acts as a vapor barrier to prevent the evaporation of solvents from the oxybutynin composition.
Additional Layers
The laminate may include additional layers such as polymeric, paper, or adhesive layers, which can be placed between the first polymer layer and the metal foil layer or on the outer surface of the metal foil layer[1].
Outer Printing Layer
An outer printing layer can be included to allow for descriptive, decorative, and/or instructional information to be printed or embossed on the device[1].
Sealing Mechanism
Edge Sealing
The edges of the device are sealed using methods such as heat, ultrasound, laser, or adhesive. A self-sealing mechanism, like heat sealing, can also be employed to form a stable bond between the facing surfaces of the same material without an adhesive[1].
Notch Formation
A notch can be formed in the edges of the device to facilitate easy opening. This notch can be a horizontal or angular slit or can be created by removing a portion of the laminate along the sealed edges[1].
Claims
The patent includes several claims that define the scope of the invention:
Claim 1
This claim describes the device as a flexible container comprising a laminate material with specific layers, including a first polymer layer, an adhesive layer, and a metal foil layer[1].
Claim 2
This claim details the method of treating overactive bladders using the topical oxybutynin composition stored in the device[1].
Dependent Claims
Subsequent claims elaborate on various aspects of the device and method, including the materials used, the sealing mechanism, and the additional layers that can be included in the laminate[1].
Patent Landscape
Prior Art
The patent references several prior art documents related to flexible containers and topical compositions. These include U.S. Pat. Nos. 4,998,621; 5,268,209; 5,400,808; 6,326,069; and 6,905,016, which describe various container systems and support structures for stored materials[1].
Related Patents
Other patents in the field of urology and pharmaceutical packaging may intersect with this invention. For instance, patents related to the delivery of topical medications or innovative packaging solutions could be relevant[4].
Economic and Practical Impact
Market Need
The invention addresses a significant market need by providing a localized treatment option for overactive bladders, reducing the risk of systemic side effects associated with oral medications.
Competitive Advantage
The unique device and method described in this patent offer a competitive advantage in the pharmaceutical and medical device industries by providing a more targeted and potentially safer treatment option.
Legal Considerations
Patent Infringement
Claims of patent infringement related to this patent would need to follow the guidelines set by the Department of Defense and the USPTO, including detailed allegations of infringement, requests for compensation, and identification of the alleged infringing item or process[2].
Small Claims Patent Court
The concept of a small claims patent court, as studied by the Administrative Conference of the United States (ACUS), could potentially impact how disputes related to this patent are resolved. Such a court would aim to provide a more streamlined and cost-effective process for resolving patent disputes[5].
Key Takeaways
- Innovative Device: The patent describes a unique flexible container for storing and administering topical oxybutynin compositions.
- Layered Structure: The device consists of multiple layers, including a polymer layer, an adhesive layer, and a metal foil layer.
- Sealing Mechanism: The device uses a self-sealing mechanism or other methods to seal the edges.
- Market Impact: The invention addresses a significant market need by providing a localized treatment option for overactive bladders.
- Legal Considerations: Patent infringement claims and the potential for a small claims patent court are important legal aspects to consider.
FAQs
Q: What is the primary purpose of the device described in US 8,920,392?
A: The primary purpose is to store and administer topical oxybutynin compositions for treating overactive bladders.
Q: What materials are used in the laminate of the device?
A: The laminate includes a first polymer layer, an adhesive layer, and a metal foil layer, with optional additional layers.
Q: How are the edges of the device sealed?
A: The edges can be sealed using methods such as heat, ultrasound, laser, or adhesive, including a self-sealing mechanism.
Q: What is the significance of the metal foil layer in the device?
A: The metal foil layer acts as a vapor barrier to prevent the evaporation of solvents from the oxybutynin composition.
Q: How does this invention impact the treatment of overactive bladders?
A: It provides a localized treatment option, reducing the risk of systemic side effects associated with oral medications.
Sources
- US8920392B2 - Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions - Google Patents.
- Requirements for filing an administrative claim for patent infringement - Acquisition.gov.
- Patent Claims Research Dataset - USPTO.
- Search for patents - USPTO.
- U.S. Patent Small Claims Court - ACUS.
