United States Patent 10,787,671: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 10,787,671, titled "Method for production of recombinant Erwinia asparaginase," is a significant patent in the field of biotechnology, particularly in the production of recombinant enzymes. This patent, granted to its inventors, outlines innovative methods for producing asparaginase, an enzyme crucial in the treatment of certain cancers.
Background of Asparaginase
Asparaginase is an enzyme that catalyzes the hydrolysis of the amino acid asparagine to aspartic acid and ammonia. It is widely used in the treatment of acute lymphoblastic leukemia (ALL) due to its ability to deplete asparagine, which is essential for the survival of certain cancer cells[4].
Patent Overview
Publication Details
- Publication Number: US10787671B2
- Filing Date: Derived from the application US201816163382A
- Grant Date: The patent was granted, though the exact date is not specified in the provided sources.
Prior Art and Related Technologies
The patent builds upon prior art related to the production of asparaginase, including methods involving other bacteria like Pseudomonas fluorescens. The current patent focuses on Erwinia, a genus known for its high expression levels of the enzyme[1].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. Here are some key aspects:
Expression in Host Cells
- The patent claims methods for producing recombinant Erwinia asparaginase with high expression levels in the periplasm or cytoplasm of the host cell. This is crucial for achieving high yields of the enzyme[1].
Activity and Stability
- The claims emphasize that the produced asparaginase has activity comparable to commercially available forms, ensuring its efficacy in medical applications[1].
Optimization and Secretion
- The methods described include optimization techniques for enhancing the secretion of the enzyme from the host cells, which is vital for efficient production[1].
Independent and Dependent Claims
- Independent Claims: These define the broadest scope of the invention, typically outlining the core method or product.
- Dependent Claims: These narrow down the scope by specifying particular aspects or variations of the independent claims, such as specific host cells, expression vectors, or conditions for optimization[1].
Patent Landscape
Related Patents and Technologies
- Other patents, such as CN-111278852-B, also describe methods for producing recombinant asparaginase from different bacteria, highlighting the competitive landscape in this field[2].
Patent Scope Metrics
Research on patent scope, such as the work by Alan C. Marco et al., suggests that the scope of a patent can be measured by metrics like independent claim length and count. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and shorter examination processes[3].
Key Innovations
High Expression Levels
- The patent's focus on achieving high expression levels in the periplasm or cytoplasm of the host cell is a significant innovation. This ensures that the produced asparaginase is not only active but also abundant, making it more viable for commercial and medical use[1].
Optimization Techniques
- The methods described for optimizing the production process, including secretion and expression, are critical for improving the yield and efficiency of asparaginase production[1].
Industrial and Medical Implications
Medical Use
- Asparaginase produced through these methods is used in the treatment of ALL and other cancers. The high activity and stability of the enzyme ensure its effectiveness in depleting asparagine, thereby inhibiting the growth of cancer cells[4].
Commercial Production
- The optimized production methods outlined in the patent are crucial for commercial-scale production of asparaginase. This can lead to more cost-effective and efficient manufacturing processes, making the enzyme more accessible for medical use[1].
Challenges and Considerations
Regulatory Compliance
- The production and use of recombinant enzymes like asparaginase must comply with regulatory standards. For instance, the FDA has specific guidelines for the use of such enzymes in medical treatments, including monitoring for adverse effects like liver toxicity[4].
Intellectual Property
- The patent landscape in biotechnology is complex, with multiple patents covering various aspects of enzyme production. Navigating this landscape to avoid infringement while innovating is a significant challenge[3].
Conclusion
The United States Patent 10,787,671 represents a significant advancement in the production of recombinant Erwinia asparaginase. Its focus on high expression levels, optimization techniques, and efficient secretion methods makes it a valuable contribution to both the medical and biotechnology industries.
Key Takeaways
- High Expression Levels: The patent describes methods to achieve high expression levels of asparaginase in host cells.
- Optimization Techniques: The methods include optimization for secretion and expression, enhancing the yield and efficiency of asparaginase production.
- Medical Use: The produced asparaginase is crucial for treating ALL and other cancers.
- Commercial Production: The optimized methods are vital for commercial-scale production, making the enzyme more accessible.
- Regulatory Compliance: The production and use must comply with regulatory standards.
FAQs
What is the primary focus of the United States Patent 10,787,671?
The primary focus is on methods for producing recombinant Erwinia asparaginase with high expression levels in host cells.
How does the patent improve asparaginase production?
The patent outlines optimization techniques for enhancing the secretion and expression of asparaginase, leading to higher yields and more efficient production.
What is the medical significance of asparaginase?
Asparaginase is used in the treatment of acute lymphoblastic leukemia (ALL) and other cancers by depleting asparagine, which is essential for the survival of certain cancer cells.
What are the regulatory considerations for this patent?
The production and use of recombinant asparaginase must comply with FDA guidelines, including monitoring for adverse effects like liver toxicity.
How does this patent fit into the broader patent landscape?
The patent is part of a competitive landscape in biotechnology, with other patents covering similar aspects of enzyme production, and its scope is defined by metrics such as independent claim length and count.
Sources
- US10787671B2 - Method for production of recombinant Erwinia asparaginase - Google Patents
- CN-111278852-B - Unified Patents Portal
- Patent Claims and Patent Scope - Hoover Institution
- RYLAZE - FDA Label
