United States Patent 10,124,142: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,124,142, issued on November 13, 2018, is a significant patent in the field of medical technology, particularly concerning the delivery of nitric oxide (NO) for therapeutic purposes. This patent is assigned to VERO BIOTECH LLC and inventors David P. Rounbehler and David H. Fine.
Background and Context
Nitric oxide is a crucial therapeutic agent used in various medical conditions, including the treatment of pulmonary hypertension and hypoxic respiratory failure, especially in premature neonates[4].
Patent Overview
Title and Abstract
The patent titled "Conversion of nitrogen dioxide (NO2) to nitric oxide (NO)" describes a system for delivering nitric oxide by converting nitrogen dioxide (NO2) into nitric oxide (NO). This conversion is facilitated using a surface-active material, such as silica gel, coated with an aqueous solution of an antioxidant, like ascorbic acid[2].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. Key claims include:
- A method for converting NO2 to NO using a surface-active material coated with an antioxidant.
- A device comprising a cartridge with the surface-active material and antioxidant solution.
- The use of specific antioxidants, such as ascorbic acid, to enhance the conversion efficiency[2].
Dependent Claims
Dependent claims further specify the details of the invention, including the types of surface-active materials, the concentration of the antioxidant solution, and the operational parameters of the device.
Patent Scope and Breadth
The scope of this patent is relatively narrow, focusing on a specific method and device for converting NO2 to NO. This narrow scope is beneficial as it reduces the likelihood of patent infringement disputes and ensures clarity in the claims. Research suggests that narrower claims are associated with a higher probability of grant and a shorter examination process[3].
Patent Landscape
Related Patents
Several related patents filed by VERO BIOTECH LLC and the same inventors expand on the technology and applications of nitric oxide delivery systems:
- Patent 10,213,572: Describes a nitric oxide delivery system with a cassette for storing liquid NO and converting it to NO using a heating element[2].
- Patent 10,737,051: Focuses on a nitric oxide storage device with similar conversion mechanisms[2].
- Patent 10,926,054: Details various systems and devices for generating nitric oxide, including the use of a porous solid matrix coated with an antioxidant[2].
Patent Expiration Dates
The patent 10,124,142 is set to expire on August 18, 2025. Other related patents have varying expiration dates, with some extending up to 2036[2].
Innovation and Impact
Therapeutic Applications
The invention described in this patent has significant therapeutic implications, particularly in the treatment of pulmonary hypertension and other respiratory conditions. The ability to deliver nitric oxide safely and efficiently is crucial for patient care[4].
Market and Competitive Landscape
The patent landscape indicates a strong presence of VERO BIOTECH LLC in the nitric oxide delivery system market. The company's multiple patents in this area suggest a robust research and development effort, which could provide a competitive advantage.
Legal and Regulatory Aspects
Patent Protection
The patent assigns exclusive legal rights to VERO BIOTECH LLC, protecting the proprietary chemical formulation and delivery system. This protection is crucial for maintaining market exclusivity and preventing unauthorized use of the technology[2].
FDA Exclusivity
While the patent provides legal protection, FDA exclusivity periods can also grant sole marketing rights to the manufacturer. However, these periods may run concurrently with the patent term[2].
Expert Insights and Statistics
Clinical Significance
"Inhalation of low levels of nitric oxide can rapidly and safely decrease pulmonary hypertension in mammals," according to the inventors. This underscores the clinical significance of the technology[2].
Market Statistics
The demand for nitric oxide delivery systems is increasing due to their therapeutic efficacy. For instance, the global market for respiratory care devices, which includes nitric oxide delivery systems, is projected to grow significantly over the next few years.
Challenges and Future Directions
Patent Litigation and Infringement
The narrow scope of the patent reduces the risk of litigation, but ongoing monitoring is necessary to prevent infringement. The complexity of patent claims and the evolving nature of medical technology make continuous legal vigilance essential[3].
Technological Advancements
Future research may focus on improving the efficiency of the conversion process, exploring new materials and antioxidants, and expanding the therapeutic applications of nitric oxide.
Key Takeaways
- The patent 10,124,142 describes a specific method and device for converting NO2 to NO using a surface-active material and antioxidant.
- The patent has a relatively narrow scope, which enhances its clarity and reduces litigation risks.
- Related patents by VERO BIOTECH LLC indicate a robust presence in the nitric oxide delivery system market.
- The technology has significant therapeutic implications and is protected by exclusive legal rights.
- Ongoing legal and technological vigilance is necessary to maintain market exclusivity and drive innovation.
Frequently Asked Questions (FAQs)
What is the primary purpose of United States Patent 10,124,142?
The primary purpose is to describe a method and device for converting nitrogen dioxide (NO2) into nitric oxide (NO) for therapeutic use.
Who are the inventors and assignees of this patent?
The inventors are David P. Rounbehler and David H. Fine, and the assignee is VERO BIOTECH LLC.
What is the significance of using ascorbic acid in this patent?
Ascorbic acid is used as an antioxidant to enhance the efficiency of the NO2 to NO conversion process.
When does the patent expire?
The patent is set to expire on August 18, 2025.
How does this patent fit into the broader patent landscape for nitric oxide delivery systems?
This patent is part of a series of related patents by VERO BIOTECH LLC, which collectively cover various aspects of nitric oxide generation and delivery systems.
Cited Sources:
- United States Patent and Trademark Office. United States Patent 10,814,092 B2, October 27, 2020.
- Drugs.com. Generic Genosyl Availability, November 6, 2024.
- Hoover Institution. Patent Claims and Patent Scope, August 18, 2024.
- DrugBank. Nitric Oxide: Uses, Interactions, Mechanism of Action.