United States Patent 10,772,883: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,772,883, titled "Diketopiperazine microparticles with defined specific surface areas," is a significant patent in the field of pharmaceuticals and materials science. This patent, granted to inventors Stowell, Grant, Menkin, and Freeman, introduces a novel method for producing diketopiperazine microparticles with specific surface areas, which has implications for drug delivery and other biomedical applications.
Background
Diketopiperazines (DKPs) are cyclic dipeptides that have been explored for their potential in drug delivery systems due to their biocompatibility and ability to form stable microparticles. The patent addresses the need for microparticles with controlled specific surface areas, which is crucial for optimizing the release of active pharmaceutical ingredients.
Scope of the Patent
The scope of the patent is focused on the production and characteristics of diketopiperazine microparticles with defined specific surface areas. Here are the key aspects:
Specific Surface Area
The patent specifies that the diketopiperazine microparticles have a specific surface area of less than about 67 m²/g. This precise control over surface area is critical for ensuring consistent performance in various applications[1][5].
Production Method
The method of producing these microparticles involves several steps, including the synthesis of diketopiperazine, the formation of a feed solution, and the use of spray drying or other drying techniques to create the microparticles. The process is designed to control the particle size and surface area accurately[1][5].
Applications
The microparticles are intended for use in pharmaceutical formulations, particularly for controlled release of drugs. They can also be used in other biomedical applications, such as vaccine delivery and tissue engineering.
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1: Describes the diketopiperazine microparticles with a specific surface area of less than about 67 m²/g.
- Claim 2: Specifies the method of producing the microparticles, including the steps of synthesizing diketopiperazine and forming a feed solution.
- Claim 3: Details the use of spray drying or other drying methods to create the microparticles[1][5].
Dependent Claims
- These claims further specify the characteristics of the microparticles, such as particle size, morphology, and the presence of additional components like antigens, hormones, or cytotoxic agents[1].
Patent Landscape
The patent landscape surrounding US 10,772,883 is complex and involves several related patents and technologies:
Related Patents
- Other patents related to diketopiperazine microparticles and their applications in drug delivery and biomedical fields are part of the broader patent family. These patents often overlap in their claims and methods, highlighting the competitive and innovative nature of this field[1].
Prior Art
- The patent cites several prior art references related to microparticle production and drug delivery systems. These references underscore the advancements made by the current patent in achieving controlled specific surface areas[1].
Global Dossier
- The Global Dossier service provided by the USPTO allows users to view the file histories of related applications from participating IP Offices. This service can help in understanding the global patent family and the evolution of the technology[4].
Impact on the Industry
The patent has several implications for the pharmaceutical and biomedical industries:
Controlled Release
- The ability to control the specific surface area of microparticles enhances the precision of drug release profiles, which is crucial for therapeutic efficacy and patient safety[1].
Biocompatibility
- The use of diketopiperazine, a biocompatible material, ensures that the microparticles are safe for use in various biomedical applications[1].
Innovation
- The patent encourages further innovation in the field by providing a novel method for producing microparticles with defined properties. This can lead to new formulations and applications in drug delivery and beyond[1].
Legal and Regulatory Aspects
The patent's legal and regulatory status is important for understanding its validity and enforcement:
Patent Term
- The patent's term is subject to the standard patent term adjustments and any potential extensions or disclaimers. Understanding these aspects is crucial for determining the patent's lifespan and any potential challenges or disputes[2].
Obviousness and Double Patenting
- The patent must withstand challenges related to obviousness and double patenting. The USPTO and courts may review these aspects to ensure the patent's validity and to prevent overlapping claims[2][3].
Key Takeaways
- Specific Surface Area Control: The patent introduces a method to produce diketopiperazine microparticles with controlled specific surface areas, which is vital for drug delivery and biomedical applications.
- Production Method: The method involves synthesizing diketopiperazine and using spray drying or other drying techniques to form the microparticles.
- Applications: The microparticles are suitable for pharmaceutical formulations, vaccine delivery, and tissue engineering.
- Patent Landscape: The patent is part of a broader landscape involving related patents and technologies in drug delivery and biomedical fields.
- Industry Impact: The patent enhances the precision of drug release profiles and encourages further innovation in the field.
FAQs
What is the primary innovation of US Patent 10,772,883?
The primary innovation is the method to produce diketopiperazine microparticles with a specific surface area of less than about 67 m²/g.
What are the potential applications of these microparticles?
The microparticles are intended for use in pharmaceutical formulations, vaccine delivery, and tissue engineering.
How are the microparticles produced?
The production involves synthesizing diketopiperazine, forming a feed solution, and using spray drying or other drying techniques.
What is the significance of controlling the specific surface area?
Controlling the specific surface area is crucial for ensuring consistent performance and optimizing the release of active pharmaceutical ingredients.
Are there any related patents or technologies in this field?
Yes, there are several related patents and technologies in the field of drug delivery and biomedical applications that overlap with this patent.
Sources
- US10772883B2 - Diketopiperazine microparticles with defined specific surface areas - Google Patents
- In re Cellect - United States Court of Appeals for the Federal Circuit
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO
- Diketopiperazine microparticles with defines specific surface areas - RTI International
