United States Patent 9,439,985: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,439,985, titled "Compositions and Methods for Radiolabeling Diethylenetriaminepentaacetic Acid (DTPA)-Dextran with Technetium-99m," is a significant patent in the field of medical diagnostics. This patent, held by Navidea Biopharmaceuticals, Inc., pertains to the development and use of specific compositions for radiolabeling, which are crucial in medical imaging and diagnostics.
Background
The patent focuses on the radiolabeling of DTPA-dextran with Technetium-99m, a radioactive isotope commonly used in nuclear medicine for imaging purposes. This technology is particularly relevant in lymphatic mapping, where it helps in locating lymph nodes draining a primary tumor site[4].
Scope of the Patent
Invention Overview
The patent describes compositions and methods for radiolabeling DTPA-dextran with Technetium-99m. This involves the preparation of lyophilized kits that can be reconstituted with Technetium-99m pertechnetate to form a radiolabeled complex. The invention also includes methods for making and using these compositions, which are essential for diagnostic imaging procedures[2][5].
Key Components
- DTPA-Dextran Complex: The patent details the synthesis and use of a DTPA-dextran complex, which is a conjugate of diethylenetriaminepentaacetic acid (DTPA) and dextran. This complex is designed to chelate Technetium-99m effectively.
- Radiolabeling Process: The process involves reconstituting a lyophilized kit with Technetium-99m pertechnetate to form a stable radiolabeled complex.
- Diagnostic Applications: The primary application is in lymphatic mapping, where the radiolabeled complex helps in identifying lymph nodes that drain a primary tumor site[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover:
- The composition of the DTPA-dextran complex.
- The method of preparing the lyophilized kit.
- The process of reconstituting the kit with Technetium-99m pertechnetate.
- The use of the radiolabeled complex in diagnostic imaging, particularly in lymphatic mapping[2].
Dependent Claims
Dependent claims further specify and narrow down the scope of the independent claims. These may include specific ratios of DTPA to dextran, particular methods of synthesis, or specific conditions for reconstitution and use.
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 9,439,985 includes other patents related to radiolabeling and diagnostic imaging. For example:
- U.S. Patent Nos. 6,409,990 and 8,545,808: These patents, also held by Navidea Biopharmaceuticals, Inc., cover related compositions and methods for lymphatic mapping and radiolabeling[4].
Global Dossier and International Patent Offices
The patent is part of a larger global patent family, with related applications and grants in other countries. Tools like the Global Dossier and databases from international intellectual property offices (such as the European Patent Office, Japan Patent Office, and World Intellectual Property Organization) provide access to file histories and related applications, helping to understand the global scope of this patent[1].
Citation Data
The Common Citation Document (CCD) application consolidates prior art cited by participating offices for the family members of this patent, providing a comprehensive view of the prior art landscape[1].
Economic and Market Impact
Market Dominance
Patents like U.S. Patent 9,439,985 play a crucial role in giving companies a competitive edge in the market. By protecting the specific compositions and methods for radiolabeling, Navidea Biopharmaceuticals, Inc. can maintain market dominance in the field of lymphatic mapping and diagnostic imaging.
Innovation and R&D
The patent encourages innovation and research and development in the field. By protecting intellectual property, companies are incentivized to invest in further research, leading to advancements in medical diagnostics and treatments.
Legal and Regulatory Aspects
Patent Enforcement
The patent notice under 35 U.S.C. ยง287(a) serves as a warning to potential infringers, indicating that the products covered by this patent are protected by law. This helps in enforcing the patent rights and preventing unauthorized use[4].
Expiration and Maintenance
Patents have a limited lifespan, typically 20 years from the filing date. Maintaining the patent through periodic fees and ensuring compliance with regulatory requirements is essential to keep the protection in force.
Conclusion
U.S. Patent 9,439,985 is a significant intellectual property asset in the field of medical diagnostics, particularly in lymphatic mapping. Understanding the scope, claims, and patent landscape of this invention is crucial for both the patent holder and potential competitors. This analysis highlights the importance of this patent in protecting innovative compositions and methods, driving market competition, and fostering further innovation.
Key Takeaways
- Invention Scope: The patent covers compositions and methods for radiolabeling DTPA-dextran with Technetium-99m.
- Diagnostic Applications: The primary application is in lymphatic mapping.
- Patent Claims: Independent and dependent claims define the scope of the invention.
- Global Patent Family: The patent is part of a larger global patent family.
- Market Impact: The patent gives the holder a competitive edge and incentivizes further innovation.
FAQs
Q: What is the main subject of U.S. Patent 9,439,985?
A: The main subject is the compositions and methods for radiolabeling DTPA-dextran with Technetium-99m.
Q: What is the primary application of this patent?
A: The primary application is in lymphatic mapping to locate lymph nodes draining a primary tumor site.
Q: How does the patent protect the invention?
A: The patent protects the invention through independent and dependent claims that define the composition, preparation, and use of the radiolabeled complex.
Q: Is this patent part of a global patent family?
A: Yes, the patent is part of a larger global patent family with related applications and grants in other countries.
Q: What is the significance of the Common Citation Document (CCD) in this context?
A: The CCD consolidates prior art cited by participating offices, providing a comprehensive view of the prior art landscape for the patent family.
