United States Patent 10,076,614: A Comprehensive Analysis of Scope and Claims
Introduction
The United States Patent 10,076,614, titled "Nasal delivery devices," is a significant innovation in the field of medical devices, particularly for the delivery of substances to the nasal cavity. This patent, granted to the inventors, outlines a novel design and method for delivering medicaments, vaccines, or other substances directly to the nasal airway. Here, we delve into the details of the patent, its scope, and the broader patent landscape it inhabits.
Background and Context
The nasal airway is a complex anatomical structure that includes two nasal cavities separated by the nasal septum. It communicates with the nasopharynx, oral cavity, and lower airway, making it a critical pathway for respiratory and systemic drug delivery[1].
Patent Overview
Invention Description
The patent describes a nasal delivery device designed to deliver substances such as liquids, suspensions, solutions, or powders containing medicaments or vaccines to the nasal airway. The device consists of a housing, a nosepiece, and various components to ensure efficient delivery.
Key Components
- Housing: The main body of the device that contains the substance to be delivered.
- Nosepiece: Designed to fit into the nasal cavity, ensuring proper placement and delivery of the substance.
- Coupling Member: Connects the housing to the nosepiece, facilitating the transfer of the substance.
- Longitudinal Axis: The alignment of the device to match the anatomy of the nasal cavity[1].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. These claims are categorized into independent and dependent claims.
- Independent Claims: These define the broadest scope of the invention, including the overall structure and function of the nasal delivery device.
- Dependent Claims: These narrow down the scope by specifying particular features or embodiments of the device, such as the material of the nosepiece or the mechanism of substance delivery[1].
Claim Types
- Mechanically Breath-Triggered Claims: The device is activated by the user's breath, ensuring synchronized delivery with inhalation.
- Exhalation-Activated Claims: The device can also be activated by exhalation, providing an alternative delivery mechanism[1].
Technical Details
Delivery Mechanism
The device is designed to deliver substances in various forms, including liquids and powders. The nosepiece is crucial for ensuring that the substance reaches the intended area within the nasal cavity.
Materials and Construction
The device may be made from materials that provide elastic properties, facilitating deformation without breaking. This ensures comfort and safety during use[1].
Patent Classification
The patent is classified under several categories within the International Patent Classification (IPC) system:
- A61M15/00: Inhalators
- A61M15/0091: Mechanically breath-triggered inhalators
- A61M15/0098: Inhalators activated by exhalation
- A61M2202/06: Solids, including powders[1].
Market and Industrial Impact
Competitive Landscape
The issuance of this patent strengthens the intellectual property portfolio of companies involved in nasal drug delivery. For example, Optinose, a company specializing in nasal spray technologies, has also secured multiple patents for their products, such as XHANCE (fluticasone propionate)[4].
Innovation and Advancements
This patent contributes to the advancement of nasal drug delivery technologies, offering improved efficacy and patient compliance. The innovative design and functionality of the device make it a valuable asset in the pharmaceutical and medical device industries.
Legal and Regulatory Considerations
Inventorship
The determination of true and only inventors is crucial for the validity of the patent. US patent law requires that the inventors listed are those who conceived the idea and reduced it to practice[2].
Patent Enforcement and Challenges
A thorough job of invention disclosure is essential to ensure that the patent remains enforceable. Incorrect or incomplete identification of inventors can lead to challenges and potential invalidation of the patent[2].
Future Directions and Trends
Small Claims Patent Court
There is an ongoing discussion about the establishment of a small claims patent court to address issues related to patent disputes, particularly for smaller entities. This could impact the enforcement and litigation landscape for patents like US 10,076,614[5].
Patent Scope Measurements
The USPTO has developed datasets and measures to analyze patent scope, which can help in understanding the breadth and depth of patent protection. This is particularly relevant for assessing the competitive position of patented technologies[3].
Key Takeaways
- Innovative Design: The patent introduces a novel nasal delivery device with a housing, nosepiece, and coupling member.
- Delivery Mechanisms: The device can be mechanically breath-triggered or activated by exhalation.
- Materials: The use of elastic materials ensures comfort and safety.
- Market Impact: Strengthens the intellectual property portfolio in the pharmaceutical and medical device industries.
- Legal Considerations: Proper inventorship and thorough invention disclosure are critical for patent validity.
FAQs
Q: What is the primary purpose of the nasal delivery device described in US Patent 10,076,614?
A: The primary purpose is to deliver substances such as medicaments, vaccines, or other pharmaceuticals directly to the nasal airway.
Q: How is the device activated?
A: The device can be activated either mechanically by the user's breath or by exhalation.
Q: What materials are recommended for the construction of the device?
A: Materials providing elastic properties are recommended to facilitate deformation without breaking.
Q: Under which IPC categories is the patent classified?
A: The patent is classified under A61M15/00, A61M15/0091, A61M15/0098, and A61M2202/06.
Q: Why is proper inventorship important for this patent?
A: Proper inventorship is crucial to ensure the patent's validity and enforceability, as incorrect identification can lead to challenges and potential invalidation.
Sources
- US10076614B2 - Nasal delivery devices - Google Patents
- Determining Inventorship for US Patent Applications
- Patent Claims Research Dataset - USPTO
- Optinose Announces Issuance of Four Additional U.S. Patents Covering XHANCE
- U.S. Patent Small Claims Court - ACUS