United States Patent 5,686,060: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,686,060, titled "Stable microbubble suspensions comprising saturated phospholipids for ultrasound echography," is a significant patent in the field of medical imaging. This patent, issued on November 11, 1997, has played a crucial role in the development of ultrasound contrast agents.
Inventors and Assignees
The patent was invented by Michel Schneider, Jean Brochot, Jerome Puginier, and Feng Yan. The rights to this patent have been assigned several times, with the most recent assignment being to Bracco Suisse SA in 2010[2].
Patent Claims
The patent claims the invention of stable microbubble suspensions composed of gas-filled microbubbles in an aqueous carrier liquid, specifically using saturated phospholipids. These microbubbles are designed for use as contrast agents in ultrasound echography. The claims include:
- The composition of the microbubble suspensions.
- The method of preparing these suspensions.
- The use of these suspensions as contrast agents in ultrasound imaging[1][2].
Key Components of the Invention
Microbubble Composition
The microbubbles are filled with a gas, typically sulfur hexafluoride, and are stabilized by a shell composed of saturated phospholipids. This composition ensures the stability and longevity of the microbubbles, making them effective contrast agents[1].
Preparation Method
The patent describes a specific method for preparing these microbubble suspensions, which involves the use of an aqueous carrier liquid and the incorporation of saturated phospholipids to stabilize the microbubbles[1].
Use in Ultrasound Echography
The microbubble suspensions are designed to enhance the contrast in ultrasound imaging, allowing for clearer and more detailed images of internal structures. This is particularly useful in medical diagnostics, such as cardiac and vascular imaging[1].
Patent Term and Extensions
The original expiration date of the patent was November 11, 2014. However, an interim extension was granted under 35 U.S.C. § 156(e)(2), extending the patent term until November 11, 2015, due to the approval of the product LUMASON™ (sulfur hexafluoride microbubbles) by the FDA[2][5].
Product Approval and Commercial Use
The patent claims the approved product LUMASON™, which is used as a contrast agent in ultrasound imaging. The FDA approval of LUMASON™ on October 10, 2014, was a significant milestone, highlighting the commercial viability and medical importance of the invention[2].
Patent Landscape
Related Patents and Technologies
The patent landscape in the field of ultrasound contrast agents is complex, with numerous patents covering various aspects of microbubble composition, preparation, and use. The Cooperative Patent Classification (CPC) database and the PATENTSCOPE database can be used to identify relevant classification schemes and international patent applications related to this technology[4].
Competitive Environment
Companies like Bracco Suisse SA, which currently holds the rights to this patent, are key players in the market for ultrasound contrast agents. The competitive environment is driven by continuous innovation in microbubble technology and the development of new contrast agents[2].
Economic and Research Impact
Economic Impact
The extension of the patent term and the commercial success of LUMASON™ have significant economic implications. The product's approval and extended patent protection have allowed Bracco Suisse SA to maintain market exclusivity, influencing the market dynamics for ultrasound contrast agents[2][5].
Research Impact
The invention has also spurred further research in the field of ultrasound imaging. The use of stable microbubble suspensions has opened new avenues for diagnostic imaging, encouraging the development of more advanced contrast agents and imaging techniques[1].
Legal and Regulatory Aspects
The patent has undergone several legal and regulatory processes, including assignments and extensions. The interim extension granted under 35 U.S.C. § 156(e)(2) is a notable example, highlighting the regulatory framework that governs patent term extensions in the United States[2][5].
Conclusion and Future Perspectives
United States Patent 5,686,060 has been a cornerstone in the development of ultrasound contrast agents. Its impact on medical diagnostics and the market for imaging agents is substantial. As the field continues to evolve, we can expect further innovations in microbubble technology and ultrasound imaging.
Key Takeaways
- Invention: Stable microbubble suspensions using saturated phospholipids for ultrasound echography.
- Claims: Composition, preparation method, and use as contrast agents.
- Assignees: Originally assigned to Sintetica S.A., later to Bracco International B.V., and currently to Bracco Suisse SA.
- Patent Term: Originally set to expire on November 11, 2014, extended until November 11, 2015.
- Product Approval: LUMASON™ (sulfur hexafluoride microbubbles) approved by the FDA on October 10, 2014.
- Economic and Research Impact: Significant economic and research implications in the field of ultrasound imaging.
Frequently Asked Questions (FAQs)
What is the main invention described in United States Patent 5,686,060?
The main invention is stable microbubble suspensions composed of gas-filled microbubbles in an aqueous carrier liquid, stabilized by saturated phospholipids, for use as contrast agents in ultrasound echography.
Who are the inventors of this patent?
The inventors are Michel Schneider, Jean Brochot, Jerome Puginier, and Feng Yan.
What is the current status of the patent?
The patent originally expired on November 11, 2014, but was extended until November 11, 2015, under 35 U.S.C. § 156(e)(2).
What product is claimed by this patent?
The patent claims the approved product LUMASON™, which is sulfur hexafluoride microbubbles used as a contrast agent in ultrasound imaging.
Why was the patent term extended?
The patent term was extended due to the FDA approval of LUMASON™, which allowed for an interim extension under 35 U.S.C. § 156(e)(2).
Cited Sources:
- US5686060A - Stable microbubble suspensions comprising saturated phospholipids for ultrasound echography - Google Patents
- In Re: Patent Term Extension Application for U.S. Patent No. 5,686,060 - Regulations.gov
- Patent Claims Research Dataset - USPTO
- Research and Course Guides: Patent Searching, Advanced: Overview - Clemson University
- Grant of Interim Extension of the Term of U.S. Patent No. 5686060 - Federal Register
