United States Patent 9,393,213: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,393,213, titled "Nanocrystals, compositions, and methods that aid particle transport in mucus," is a significant patent that addresses the challenges of drug delivery through mucus-lined tissues. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Motivation
The patent focuses on overcoming the barriers posed by mucus in the delivery of therapeutic agents. Mucus, a complex and dynamic biological matrix, can hinder the penetration and retention of particles, including drugs and diagnostic agents. The inventors aimed to develop nanocrystals and compositions that can effectively navigate through mucus, enhancing the efficacy of various medical treatments.
Scope of the Patent
The scope of US Patent 9,393,213 is broad and encompasses several key areas:
Nanocrystals and Compositions
The patent describes the creation and use of nanocrystals, which are designed to interact favorably with mucus. These nanocrystals can be made from a variety of materials, including polymers such as polyethylene glycol (PEG) and polypropylene glycol (PPG), and can be formulated to carry therapeutic or diagnostic agents[1].
Methods for Particle Transport
The methods outlined in the patent involve the use of these nanocrystals to enhance the transport of particles through mucus. This includes techniques for preparing the nanocrystals, formulating them into various dosage forms (e.g., suspensions, powders), and administering them via different routes (e.g., topical, injection)[1].
Claims of the Patent
The patent includes several claims that define the invention's scope:
Independent Claims
- Claim 1 describes a composition comprising nanocrystals with a core particle and a surface coating that facilitates transport through mucus.
- Claim 2 details a method for preparing these nanocrystals, including the steps of synthesizing the core particle and applying the surface coating[1].
Dependent Claims
- Various dependent claims elaborate on the materials used for the core particle and the surface coating, such as the use of triblock copolymers and specific polymers like PEG and PPG.
- Other claims specify the types of therapeutic or diagnostic agents that can be carried by the nanocrystals, including nucleic acids, proteins, and small molecules[1].
Key Components and Materials
The patent highlights several key components and materials crucial for the invention:
Polymers
- Polyethylene glycol (PEG) and polypropylene glycol (PPG) are prominently mentioned for their role in creating the nanocrystals and enhancing mucus penetration[1].
Surface Coatings
- The surface coatings, often made from hydrophilic polymers, are designed to reduce the hydrophobic effect and improve the mobility of the nanocrystals through mucus[1].
Therapeutic and Diagnostic Agents
- The patent includes a wide range of agents that can be delivered using these nanocrystals, such as nucleic acids, proteins, and small molecules, indicating its versatility in various medical applications[1].
Patent Landscape
The patent landscape surrounding US 9,393,213 is complex and dynamic, reflecting ongoing research and innovation in drug delivery systems:
Related Patents and Research
- Other patents and research focus on similar challenges in drug delivery, such as developing nanoparticles and microparticles that can navigate biological barriers. For example, patents related to nanoparticle design and surface modification are common in this field[5].
Industry Trends
- The trend in pharmaceutical and biotechnology industries is towards developing targeted and efficient drug delivery systems. This patent aligns with these trends by offering a novel solution for mucus-penetrating particles[1].
Regulatory and Legal Considerations
- The legal landscape for patents in the biomedical field is stringent, with ongoing discussions about the need for small claims patent courts to handle disputes and infringement cases efficiently. Studies by organizations like the Administrative Conference of the United States (ACUS) highlight the complexities and potential solutions in this area[2].
Impact and Applications
The impact of this patent is significant, with potential applications across various medical fields:
Drug Delivery
- Enhanced delivery of therapeutic agents through mucus-lined tissues can improve the efficacy of treatments for respiratory, gastrointestinal, and other diseases.
Diagnostic Agents
- The ability to deliver diagnostic agents more effectively can lead to better diagnostic outcomes and earlier disease detection.
Personalized Medicine
- The versatility of the nanocrystals in carrying different types of agents makes them suitable for personalized medicine approaches, where treatments are tailored to individual patient needs.
Challenges and Future Directions
Despite the advancements, there are challenges and future directions to consider:
Biocompatibility and Safety
- Ensuring the biocompatibility and safety of these nanocrystals is crucial for clinical applications. Further research is needed to address any potential toxicity or side effects.
Scalability and Manufacturing
- Scaling up the production of these nanocrystals while maintaining their properties is a significant challenge. Advances in manufacturing processes are necessary to make these systems widely available.
Regulatory Approvals
- Navigating the regulatory landscape to obtain approvals for clinical use is another critical step. This involves extensive testing and validation to meet regulatory standards.
Key Takeaways
- Innovative Solution: The patent offers an innovative solution for enhancing particle transport through mucus, which is a significant barrier in drug delivery.
- Versatile Applications: The nanocrystals can carry a wide range of therapeutic and diagnostic agents, making them versatile for various medical applications.
- Complex Patent Landscape: The patent landscape is complex, with ongoing research and legal considerations that impact the development and use of such technologies.
- Future Directions: Addressing biocompatibility, scalability, and regulatory approvals are key future directions for this technology.
FAQs
What is the main focus of US Patent 9,393,213?
The main focus is on developing nanocrystals and compositions that can effectively transport particles through mucus, enhancing drug delivery and diagnostic agent delivery.
What materials are used to create the nanocrystals?
The nanocrystals are made from materials such as polyethylene glycol (PEG) and polypropylene glycol (PPG), with surface coatings to facilitate mucus penetration.
What types of agents can be delivered using these nanocrystals?
The nanocrystals can deliver a variety of agents, including nucleic acids, proteins, and small molecules.
What are the potential applications of this technology?
The technology has potential applications in drug delivery for respiratory, gastrointestinal, and other diseases, as well as in diagnostic medicine.
What are the key challenges for this technology moving forward?
Key challenges include ensuring biocompatibility and safety, scaling up production, and obtaining regulatory approvals.
Cited Sources
- US9393213B2 - Nanocrystals, compositions, and methods that aid particle transport in mucus - Google Patents
- U.S. Patent Small Claims Court - Administrative Conference of the United States
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- JP-6816065-B2 | Unified Patents - Unified Patents Portal
