United States Patent 4,830,010: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,830,010, titled "Methods for the Diagnosis of Gastrointestinal Disorders," was invented by Barry J. Marshall and granted on May 16, 1989. This patent revolutionized the diagnosis of gastrointestinal disorders, particularly those caused by bacterial infections. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
The patent addresses the diagnosis of gastrointestinal disorders, which can arise from various causes including genetic, physiological, environmental, and bacterial factors. The invention focuses on detecting the presence of bacteria in the upper gastrointestinal tract, specifically those that produce urease, an enzyme that hydrolyzes urea into carbon dioxide and ammonia[1][4].
Scope of the Patent
The scope of the patent encompasses methods for diagnosing gastrointestinal disorders using isotope-labelled urea. Here are the key aspects:
- Isotope-Labelled Urea: The method involves administering a safe and effective amount of urea labelled with isotopes such as carbon-13 or carbon-14 to the subject. This isotope-labelled urea is then hydrolyzed by bacterial urease, producing labelled carbon dioxide or ammonia[1][4].
- Breath Analysis: The diagnosis is based on analyzing the breath of the subject for the presence of these hydrolysis products. This can be done using various detection methods, including beta-radiation detectors for radioactive isotopes like carbon-14[1][4].
- Time Frame: The analysis typically involves collecting breath samples over a period ranging from 1 to 180 minutes, with a preferred range of 10 to 120 minutes[4].
Claims of the Patent
The patent includes several claims that define the specific methods and components of the invention:
- Claim 1: A method for diagnosing a gastrointestinal disorder involving the administration of isotope-labelled urea and analyzing the breath for hydrolysis products[1][4].
- Claim 6: A method specifically for diagnosing disorders caused by bacteria in the upper gastrointestinal tract, using nitrogen-15 isotope-labelled urea[1].
- Claim 7: An alternative method involving the detection of ammonia as a hydrolysis product of the administered urea[1].
Key Components and Devices
The patent describes several key components and devices essential for the diagnostic method:
- Isotope-Labelled Urea: The use of carbon-13 or carbon-14 labelled urea is crucial for detecting the hydrolysis products in the breath[1][4].
- Breath Collection Devices: Devices such as balloons and Vacutainers are used to collect and store breath samples for analysis[4].
- Detection Methods: Various detection methods are mentioned, including beta-radiation detectors and other analytical techniques for detecting labelled carbon dioxide or ammonia[1][4].
Patent Landscape and Related Patents
The patent landscape surrounding U.S. Patent 4,830,010 includes several related patents and technologies:
- Prior Art: The patent references earlier patents related to breath tests and isotope-labelled compounds, such as U.S. Patents 3,679,899, 3,899,252, and 4,027,972[1].
- Commercial Feasibility: The commercial feasibility of 13C breath tests is discussed in the patent, referencing analytical chemistry symposia[1].
Impact and Significance
The invention had a significant impact on the diagnosis of gastrointestinal disorders:
- Clinical Use: The method has been widely adopted in clinical practice for diagnosing conditions such as Helicobacter pylori infections, which are associated with peptic ulcers and gastric cancer[1].
- Research and Development: The patent paved the way for further research into non-invasive diagnostic techniques using isotope-labelled compounds.
Patent Term and Extensions
The patent term for U.S. Patent 4,830,010 was extended under 35 U.S.C. § 156, which allows for the extension of patent terms in certain circumstances. The patent term was extended by 1,260 days from the original expiration date of May 16, 2006[1].
Best Practices in Patent Drafting
The drafting of this patent highlights several best practices in patent drafting, such as:
- Clear Definitions: The patent provides clear definitions of key terms and methods to avoid ambiguity and ensure consistent interpretation[2].
- Consistent Terminology: The use of consistent terminology throughout the patent application is crucial for avoiding unexpected claim constructions[2].
Challenges in Patent Litigation
Patent litigation, as seen in cases like CoolIT Sys., Inc. v. Vidal, emphasizes the importance of clear claim constructions and avoiding ambiguity in patent claims. This case highlights the need for precise definitions and consistent use of terms to avoid disputes during litigation[2].
Metrics for Measuring Patent Scope
Research on patent scope metrics, such as independent claim length and count, can provide insights into the breadth and clarity of patent claims. Narrower claims, as seen in the examination process, are often associated with a higher probability of grant and shorter examination times[3].
Key Takeaways
- Diagnostic Method: The patent introduces a non-invasive diagnostic method using isotope-labelled urea to detect gastrointestinal disorders.
- Isotope Labelling: The use of carbon-13 or carbon-14 labelled urea is central to the method.
- Breath Analysis: Breath samples are analyzed for hydrolysis products to diagnose bacterial infections.
- Clinical Impact: The method has significantly improved the diagnosis of conditions like Helicobacter pylori infections.
- Patent Term Extension: The patent term was extended under 35 U.S.C. § 156.
FAQs
Q: What is the primary method described in U.S. Patent 4,830,010?
A: The primary method involves administering isotope-labelled urea to a subject and analyzing the breath for hydrolysis products such as carbon dioxide or ammonia.
Q: What isotopes are commonly used in this diagnostic method?
A: Carbon-13 and carbon-14 are the isotopes commonly used to label the urea.
Q: How are breath samples collected and stored for analysis?
A: Breath samples are collected using balloons and stored in devices like Vacutainers for subsequent analysis.
Q: What is the significance of this patent in clinical practice?
A: This patent has significantly improved the diagnosis of gastrointestinal disorders, particularly those caused by bacterial infections like Helicobacter pylori.
Q: Why is clear terminology important in patent drafting?
A: Clear terminology is crucial to avoid ambiguity and ensure consistent interpretation of patent claims, especially during litigation.
Cited Sources
- United States Patent and Trademark Office, "Methods for the diagnosis of gastrointestinal disorders," U.S. Patent 4,830,010, May 16, 1989.
- Crowell & Moring LLP, "Do Your Patents Claim Engagement of Components as Intended?" Client Alert, March 20, 2024.
- SSRN, "Patent Claims and Patent Scope," September 29, 2016.
- Google Patents, "Methods for the diagnosis of gastrointestinal disorders," U.S. Patent 4,830,010A.
- USPTO, "Untitled," U.S. Patent 4,830,010, May 16, 1989.
