Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,859,186
Introduction
United States Patent 5,859,186, titled "Method for detection of HLA antigens," was granted on January 12, 1999. Assigned to One Lambda, Inc., this patent covers specific methods for detecting Human Leukocyte Antigen (HLA) proteins, which are critical in organ transplantation compatibility, disease diagnosis, and immunology research. Its broad claims and foundational position in HLA diagnostic methods have positioned it as a significant patent within the immunogenetics space, influencing subsequent innovations and patent filings.
Scope of the Patent
The patent's scope primarily encompasses laboratory methods for detecting HLA antigens, specifically utilizing polypeptide or antibody-based techniques. Its innovation lies in detecting HLA antigens via specific binding agents—namely, monoclonal or polyclonal antibodies tagged with detectable labels—applied to biological samples. The patent also encompasses methodologies for preparing and using these detection agents.
Key elements defining scope:
- Methodology: Focuses on contact of a biological sample with labeled antibody and subsequent detection, enhancement, or analysis.
- Target molecules: HLA antigens present on cell surfaces, primarily class I and class II.
- Detection techniques: Utilization of labeled antibodies or peptides that bind HLA antigens, leading to detectable signals through fluorescence, enzymatic activity, or other labeling strategies.
- Sample types: Biological samples including blood, tissue biopsies, or cultured cells.
The broad description implies applications across various immunoassay formats, including ELISA, flow cytometry, and immunohistochemistry, making the patent highly versatile in HLA detection contexts.
Claims Analysis
The patent contains 19 claims, with Claim 1 being the independent claim. The claims are designed to cover both the detection method and the components used.
Claim 1 (Independent claim):
It broadly claims:
- A method for detecting HLA antigens in a biological sample;
- Contactting the sample with a labeled antibody that specifically binds to HLA antigens;
- Detecting the bound antibody to determine the presence of HLA antigens.
Dependent Claims:
Cover:
- Variations with different labeling methods (fluorescent, enzymatic);
- Specific types of antibodies (monoclonal, polyclonal);
- Sample types, such as blood, tissue, or cell suspensions;
- Additional steps like washing or amplification.
Scope and Limitations:
The claims are broad, emphasizing any labeled antibody-based detection method for HLA antigens. However, they are limited to methods involving antibodies, excluding alternative detection molecules like recombinant proteins or aptamers, unless explicitly included in the claims.
Implication of Claims:
The structure and breadth of claims mean they potentially cover any antibody-based assay for HLA detection that meets the described steps, pertinent across diagnostic, research, and transplant compatibility testing.
Patent Landscape
The patent landscape surrounding U.S. Patent 5,859,186 reflects its foundational status in HLA diagnostic technology:
- Predecessor Technologies: Prior art mainly involved serologic methods and early immunoassays for HLA typing.
- Related Patents: Post-1999, numerous patents emerged focusing on more advanced detection modalities, including molecular techniques like PCR-based HLA typing (e.g., U.S. Patent 6,087,111) and mass spectrometry-based methods.
- Influence: This patent has served as a basis or reference for subsequent innovations, especially in antibody labeling, assay formats, and sample processing techniques.
- Legal Status: Currently, the patent has expired (its maintenance fees lapsed), freeing its claims for public use, but the foundational techniques remain integral to the field's development.
Competitive Position:
In the landscape, this patent carved out a significant niche in immunological detection methodologies for HLA antigens. Major players, such as One Lambda, have continued to innovate, with newer patents often citing or building upon this technology. Notably, the patent's expiration means that downstream innovators can now freely develop and commercialize assays based on these claims without infringement concerns.
Bridge to Molecular and Digital Technologies:
The scope of this patent is primarily immunochemical. However, the evolution of HLA detection now increasingly integrates molecular genetic methods and digital signal processing, areas not directly covered by this patent but related to the broader HLA typing landscape.
Implications for Industry and Innovation
The patent’s extensive claims provided a strong platform for developing commercial HLA detection kits and clinical diagnostics. Its influence persists in standard laboratory protocols, particularly in flow cytometry-based HLA typing, where fluorescently labeled antibodies are commonplace. Despite its expiration, the patent set early-stage technical standards, which many subsequent patents have referenced or improved upon.
The expiring patent opens opportunities for generic assay development and custom detection systems, boosting competition and lowering costs in transplant immunology diagnostics.
Conclusion
U.S. Patent 5,859,186 epitomizes a foundational approach to antibody-based HLA antigen detection. Its broad claims effectively cover a wide array of immunoassay techniques that have driven HLA typing and compatibility testing for over two decades. The patent landscape it helped shape has spurred innovation while emphasizing the importance of precise, antibody-driven detection methods in immunogenetics.
As patent protections expire, the field benefits from increased resource sharing and technological advancement, promising further enhancements in accuracy, speed, and affordability of HLA diagnostics.
Key Takeaways
- Broad Claims, Focused Scope: The patent's claims encompass a range of antibody-based detection methods for HLA antigens, primarily via labeled antibodies in various assay formats.
- Foundational Patent: It played a critical role in establishing early immunoassay techniques for HLA typing, influencing subsequent innovations.
- Patent Landscape Impact: It has served as a technological reference point, shaping both academic research and commercial assay development.
- Public Domain Status: As it has expired, the patent's techniques are now accessible for widespread use and adaptation without infringement concerns.
- Future Outlook: The expiring patent enables new customizable, molecular, or digital approaches to HLA antigen detection, fostering innovation and reducing costs.
FAQs
1. What is the primary medical application of the methods described in U.S. Patent 5,859,186?
The patent’s methods facilitate HLA antigen detection, essential for organ transplant matching, disease diagnosis, and immunological research to assess immune compatibility.
2. Does this patent cover molecular techniques for HLA typing?
No. The patent specifically pertains to antibody-based detection methods and does not encompass molecular genetic approaches like PCR or sequencing.
3. Is the patent still active?
No. The patent has expired due to non-payment of maintenance fees, placing its claims in the public domain.
4. How has this patent influenced current HLA detection technologies?
It provided a foundational framework for antibody-based assays, especially flow cytometry and immunoassays, forming the basis of many commercial kits and research protocols.
5. Can companies now freely develop laboratories tests based on this patent?
Yes, with the patent expired, companies are free to develop and commercialize new tests leveraging the described antibody detection techniques.
References
- U.S. Patent 5,859,186. Method for detection of HLA antigens. Granted January 12, 1999.
- Previous patent and literature references in immunoassay technology for HLA typing.
- Post-1999 advancements in HLA diagnostics, including molecular and digital methods cited in subsequent patents and scientific publications.
