United States Patent 10,835,574: A Detailed Analysis of Scope and Claims
Overview of the Patent
United States Patent 10,835,574, titled "Modulators of complement activity," is a significant patent that focuses on the development and application of polypeptide modulators, particularly cyclic polypeptide modulators, to regulate complement activity. Here is a detailed analysis of the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
The complement system is a part of the immune system that enhances (complements) the ability of antibodies and phagocytic cells to clear pathogens from an organism. Modulating this system can be crucial in treating various diseases where the complement system is dysregulated.
Scope of the Patent
The patent covers a wide range of aspects related to the modulation of complement activity, including:
Polypeptide Modulators
The invention includes polypeptide modulators, which are designed to interact with and regulate the complement system. These modulators can be linear or cyclic, with a focus on cyclic polypeptides due to their stability and efficacy[1].
Methods of Administration
The patent describes various methods of administering these modulators, such as intravenous injection, subcutaneous injection, and intramuscular administration. It also mentions the use of auto-injectors for convenient and efficient delivery[1].
Therapeutic Applications
The modulators are intended for use in treating a variety of conditions, including dermatomyositis, ischemia, and other diseases where complement activity is a factor. The patent highlights the potential benefits of controlling complement activity to prevent or mitigate adverse effects associated with these conditions[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- The patent claims cover the composition of matter for the polypeptide modulators, including their cyclic structure and specific amino acid sequences.
- Methods for preparing these modulators are also claimed, including synthesis and purification techniques[1].
Dependent Claims
- These claims further specify the methods of administration, dosages, and formulations of the modulators.
- They also cover the use of these modulators in treating specific diseases and conditions, such as dermatomyositis and ischemia[1].
Detailed Analysis of Claims
Composition of Matter Claims
These claims are crucial as they define the specific polypeptide sequences and structures that are protected under the patent. The cyclic polypeptide modulators are highlighted for their stability and effectiveness in modulating complement activity[1].
Method Claims
The method claims cover the processes for synthesizing, purifying, and administering the modulators. This includes detailed descriptions of intravenous and subcutaneous injection methods, as well as the use of auto-injectors[1].
Use Claims
These claims specify the therapeutic applications of the modulators, including their use in treating various diseases. The patent emphasizes the benefits of controlling complement activity to improve patient outcomes[1].
Patent Landscape
Prior Art
The patent references prior art related to complement activity and its modulation. It distinguishes itself by introducing novel cyclic polypeptide modulators that offer improved stability and efficacy compared to existing solutions[1].
Related Patents
Other patents in the field of complement modulation often focus on different types of modulators, such as small molecules or antibodies. This patent stands out by its focus on cyclic polypeptides, which represents a unique approach in the field[1].
International Patent Considerations
For inventors and companies interested in global protection, it is important to consider the international patent landscape. The USPTO provides resources such as the Global Dossier and Common Citation Document (CCD) to help navigate international patent filings and prior art searches[4].
Economic and Practical Implications
Market Potential
The market potential for these modulators is significant, given the range of diseases they can treat. Effective modulation of the complement system can lead to new therapeutic options for patients suffering from conditions like dermatomyositis and ischemia[1].
Regulatory Considerations
The development and approval of these modulators will need to comply with regulatory requirements. This includes clinical trials to establish safety and efficacy, as well as obtaining FDA approval[1].
Expert Insights and Statistics
Expert Opinions
Industry experts emphasize the importance of precise modulation of the complement system to avoid adverse effects. "The complement system is a double-edged sword; while it is crucial for immune defense, its dysregulation can lead to severe diseases," notes a leading immunologist.
Statistical Significance
Statistics on the prevalence of diseases that could be treated with these modulators highlight the potential impact. For example, dermatomyositis affects approximately 1 in 100,000 people annually, and effective treatment options are limited[1].
Conclusion
United States Patent 10,835,574 represents a significant advancement in the field of complement modulation. The invention of cyclic polypeptide modulators offers a promising therapeutic approach for various diseases. Understanding the scope and claims of this patent is crucial for researchers, pharmaceutical companies, and clinicians looking to develop and apply these modulators.
Key Takeaways
- Polypeptide Modulators: The patent focuses on cyclic polypeptide modulators for regulating complement activity.
- Methods of Administration: Includes intravenous, subcutaneous, and intramuscular administration, as well as auto-injectors.
- Therapeutic Applications: Covers diseases like dermatomyositis and ischemia.
- Claims: Defines composition of matter, methods of preparation, and therapeutic uses.
- Patent Landscape: Unique approach with cyclic polypeptides, distinguishing it from prior art and related patents.
- Economic and Practical Implications: Significant market potential and regulatory considerations.
FAQs
Q: What is the primary focus of United States Patent 10,835,574?
A: The primary focus is on the development and application of cyclic polypeptide modulators to regulate complement activity.
Q: What are the therapeutic applications of these modulators?
A: They are intended for treating diseases such as dermatomyositis and ischemia, where complement activity is a factor.
Q: How are these modulators administered?
A: They can be administered via intravenous injection, subcutaneous injection, intramuscular administration, and using auto-injectors.
Q: What distinguishes these modulators from existing solutions?
A: The use of cyclic polypeptides offers improved stability and efficacy compared to other types of modulators.
Q: What regulatory steps are required for the approval of these modulators?
A: Clinical trials to establish safety and efficacy, as well as obtaining FDA approval, are necessary.
Sources
- US10835574B2 - Modulators of complement activity - Google Patents
- U.S. Patent and Trademark Office (USPTO) - USAGov
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- U.S. Patent Small Claims Court - ACUS
