United States Patent 8,776,794: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 8,776,794, titled "Gas Delivery Device," is a critical patent in the field of medical gas delivery systems, particularly for the administration of nitric oxide. This patent is part of a broader landscape of intellectual property related to medical gas delivery and has been involved in several legal and regulatory discussions. Here, we will delve into the scope, claims, and the patent landscape surrounding this invention.
Background
The patent in question is held by Mallinckrodt plc and is associated with the INOmax® system, which is used for the delivery of nitric oxide gas for therapeutic purposes, such as treating hypoxic respiratory failure[4][5].
Patent Scope
Overview
The scope of the patent defines the boundaries of what is protected under the patent. For U.S. Patent 8,776,794, the scope is centered around a gas delivery device designed to provide therapy gas comprising nitric oxide.
Key Components
The patent describes a gas delivery device with several key components:
- Gas Source: Provides therapy gas comprising nitric oxide.
- Valve: Attachable to the gas source, including an inlet and an outlet in fluid communication, and a valve actuator to control gas flow.
- Control Module: Delivers the therapy gas in an amount effective to treat or prevent hypoxic respiratory failure.
- Circuit: Includes a memory to store gas data such as gas identification, expiration date, and concentration[4].
Claims
Claim 1
The primary claim of the patent outlines the gas delivery device's structure and function:
- A gas source to provide therapy gas comprising nitric oxide.
- A valve attachable to the gas source with an inlet, outlet, and valve actuator.
- A control module that delivers the therapy gas.
- A circuit with memory to store gas data[4].
Dependent Claims
Dependent claims further specify the details of the invention, such as the types of data stored in the memory, the functionality of the valve actuator, and the integration with other components of the gas delivery system.
Patent Landscape
Related Patents
The patent is part of a family of patents related to the INOmax® system, including U.S. Patents Nos. 8,282,966, 8,293,284, 8,431,163, 8,795,741, 8,291,904, 8,573,209, 8,573,210, 8,776,795, 9,770,570, 9,265,911, 9,279,794, 9,295,802, and 9,408,993. These patents collectively cover various aspects of the system, including the smart handle, safety checks, and other functionalities[5].
Litigation and Challenges
The patent has been involved in several legal disputes, particularly in the context of generic pharmaceuticals and medical gas delivery systems. For instance, Mallinckrodt plc has been involved in litigation with Airgas Therapeutics LLC regarding patent infringement related to the defendants' Abbreviated New Drug Application (ANDA) for a generic version of INOmax®[5].
Prior Art and Invalidity Challenges
In some cases, the validity of the patent has been challenged based on prior art. For example, the Paoli reference has been cited as describing a pre-use safety check similar to what is incorporated in the patented device. The question often revolves around whether one of ordinary skill in the art would have been motivated to combine prior art references to achieve the claimed invention[1].
Metrics for Patent Scope
Independent Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length and count can be used to measure the breadth of a patent. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Impact on Innovation
The breadth and clarity of patent claims can significantly impact innovation. Overly broad patents can lead to increased licensing and litigation costs, potentially diminishing incentives for further innovation. The specificity and clarity of the claims in U.S. Patent 8,776,794 help to define a clear scope of protection, which can facilitate innovation by providing clear boundaries for competitors and researchers[3].
Regulatory Environment
The U.S. Patent and Trademark Office (USPTO) plays a crucial role in granting and managing patents. The USPTO's processes and standards for patent examination influence the scope and validity of patents like U.S. Patent 8,776,794. Understanding the regulatory environment is essential for navigating the complexities of patent law[2].
Conclusion
U.S. Patent 8,776,794 is a significant patent in the medical gas delivery field, particularly for the administration of nitric oxide. The patent's scope and claims are well-defined, covering a gas delivery device with specific components and functionalities. The patent landscape is complex, with multiple related patents and ongoing litigation. Understanding the metrics for patent scope, the impact on innovation, and the regulatory environment is crucial for navigating the intellectual property landscape in this field.
Key Takeaways
- Specific Components: The patent covers a gas delivery device with a gas source, valve, control module, and memory to store gas data.
- Related Patents: Part of a family of patents related to the INOmax® system.
- Litigation: Involved in disputes related to generic pharmaceuticals and medical gas delivery systems.
- Prior Art Challenges: Validity has been challenged based on prior art references.
- Metrics for Scope: Narrower claims are associated with a higher probability of grant and shorter examination process.
- Impact on Innovation: Clear and specific claims can facilitate innovation by providing clear boundaries.
FAQs
What is the primary purpose of U.S. Patent 8,776,794?
The primary purpose of U.S. Patent 8,776,794 is to protect a gas delivery device designed to provide therapy gas comprising nitric oxide for treating hypoxic respiratory failure.
Which company holds this patent?
The patent is held by Mallinckrodt plc.
What are the key components of the gas delivery device described in the patent?
The key components include a gas source, a valve with an inlet and outlet, a control module, and a circuit with memory to store gas data.
Has this patent been involved in any litigation?
Yes, the patent has been involved in litigation related to generic pharmaceuticals and medical gas delivery systems.
How does the scope of this patent impact innovation?
The clear and specific claims of the patent help to define a clear scope of protection, which can facilitate innovation by providing clear boundaries for competitors and researchers.
