Detailed Analysis of the Scope and Claims of United States Patent 10,947,197
Introduction
United States Patent 10,947,197, titled "Synthesis of the radiolabeled prostate-specific membrane antigen (PSMA) inhibitor [18F]DCFPYL," is a significant patent in the field of medical diagnostics and therapeutics. This patent, assigned to The Johns Hopkins University, outlines a method for synthesizing a radiolabeled compound used in the detection and treatment of prostate cancer. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
The patent in question involves the synthesis of [18F]DCFPYL, a radiolabeled inhibitor of the prostate-specific membrane antigen (PSMA). PSMA is a protein highly expressed on the surface of prostate cancer cells, making it a prime target for diagnostic and therapeutic agents. The development of such radiolabeled compounds is crucial for improving the accuracy of cancer diagnosis and treatment[4].
Patent Scope and Claims
Overview of Claims
The patent includes a series of claims that define the scope of the invention. These claims can be broadly categorized into several types:
Composition Claims
These claims pertain to the chemical composition of the radiolabeled compound [18F]DCFPYL. They specify the molecular structure and the radioactive isotope used, which is Fluorine-18[4].
Method Claims
These claims describe the process of synthesizing [18F]DCFPYL. The method involves several steps, including the preparation of precursor molecules, the incorporation of the radioactive isotope, and the purification of the final product[4].
Use Claims
These claims outline the intended use of the radiolabeled compound, which includes its application in medical imaging and potentially in targeted therapy for prostate cancer[4].
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims stand alone and define the invention in its broadest terms, while dependent claims narrow down the invention by adding specific limitations or features to the independent claims. For example, Claim 1 might describe the general method of synthesizing [18F]DCFPYL, while Claim 2 might specify a particular step or condition within that method[4].
Patent Landscape
Related Patents and Prior Art
The patent landscape for radiolabeled PSMA inhibitors is complex and involves numerous patents and publications. The patent 10,947,197 cites several prior art documents, including other patents and scientific publications related to the synthesis and use of PSMA inhibitors. For instance, it references earlier work by Pomper et al. on similar compounds[4].
Government Interest and Funding
The Bayh-Dole Act allows universities and other recipients of federal funding to patent inventions developed using such funds. This patent, assigned to The Johns Hopkins University, likely benefited from federal funding, as indicated by the inclusion of government-interest statements in the patent text. This is a common practice for patents arising from federally supported research[1].
Metrics for Measuring Patent Scope
Claim Length and Count
The scope of a patent can be measured using metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. For instance, narrower claims with shorter lengths and fewer counts are often associated with higher patent quality and a shorter examination process[3].
Forward Citations and Patent Maintenance
The number of forward citations (citations by later patents) and patent maintenance payments can also indicate the scope and impact of a patent. Patents with more forward citations and higher maintenance payments tend to have broader scope and greater influence in their field[3].
Practical Application and Health Needs
The Bayh-Dole Act mandates that inventions arising from federally supported research must be practically applied to meet public health needs. The synthesis of [18F]DCFPYL under this patent aligns with this requirement by providing a diagnostic tool that can significantly improve the detection and treatment of prostate cancer, thereby addressing a critical health need[1].
Regulatory Compliance
The patent emphasizes the importance of regulatory compliance in the synthesis process. The method described must comply with full regulatory standards, including quality control measures such as gradient HPLC analysis. This ensures that the radiolabeled compound is safe and effective for medical use[4].
Assignee and Inventors
The patent is assigned to The Johns Hopkins University, reflecting the institution's significant contributions to medical research and innovation. The inventors listed include Hayden T. Ravert, Daniel P. Holt, Ying Chen, Ronnie C. Mease, Hong Fan, Martin G. Pomper, and Robert F. Dannals, all of whom are affiliated with The Johns Hopkins University or other nearby research institutions[4].
Conclusion
United States Patent 10,947,197 represents a critical advancement in the field of radiolabeled diagnostics for prostate cancer. The patent's scope and claims are carefully defined to protect the innovative method of synthesizing [18F]DCFPYL while ensuring its practical application to meet public health needs. Understanding the patent landscape, including related patents and regulatory compliance, is essential for navigating the complex world of medical diagnostics and therapeutics.
Key Takeaways
- Radiolabeled Compound: The patent involves the synthesis of [18F]DCFPYL, a radiolabeled inhibitor of PSMA.
- Claims: The patent includes composition, method, and use claims that define the scope of the invention.
- Patent Landscape: The patent is part of a broader landscape involving numerous related patents and prior art.
- Government Interest: The patent likely benefited from federal funding, as indicated by government-interest statements.
- Regulatory Compliance: The synthesis method must comply with full regulatory standards.
- Assignee and Inventors: The patent is assigned to The Johns Hopkins University and lists several inventors affiliated with the university.
FAQs
What is the main subject of United States Patent 10,947,197?
The main subject of this patent is the synthesis of the radiolabeled prostate-specific membrane antigen (PSMA) inhibitor [18F]DCFPYL.
Who is the assignee of this patent?
The assignee of this patent is The Johns Hopkins University.
What are the key claims in this patent?
The key claims include composition claims defining the chemical structure, method claims describing the synthesis process, and use claims outlining the medical applications.
How does this patent align with the Bayh-Dole Act?
This patent aligns with the Bayh-Dole Act by ensuring that the invention arising from federally supported research is practically applied to meet public health needs.
What metrics can be used to measure the scope of this patent?
Metrics such as independent claim length, independent claim count, forward citations, and patent maintenance payments can be used to measure the scope and impact of this patent.
Why is regulatory compliance important in this patent?
Regulatory compliance is crucial to ensure that the synthesized radiolabeled compound is safe and effective for medical use, adhering to full regulatory standards including quality control measures.
