United States Patent 12,053,546: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 12,053,546, titled "Stabilized topical formulations containing core-shell microcapsules," is a significant innovation in the field of pharmaceutical and cosmetic formulations. This patent, granted to address the stability and efficacy of topical applications, is crucial for understanding the advancements in microcapsule technology.
Background and Context
Topical formulations, whether for pharmaceutical or cosmetic use, often face challenges related to stability, bioavailability, and skin penetration. The invention described in this patent aims to overcome these issues by utilizing core-shell microcapsules.
Scope of the Patent
The patent covers a broad range of compositions and methods for preparing stabilized topical formulations. Here are the key aspects of its scope:
Composition
- The patent describes a composition in an emulsion form for topical application, which includes a plurality of first core-shell microcapsules. These microcapsules contain a core and a shell, where the core can be made of various active ingredients such as benzoyl peroxide, and the shell is typically a polymer material[1].
Core-Shell Microcapsules
- The core-shell microcapsules are designed to enhance the stability and delivery of the active ingredients. The core can be formulated with different substances, and the shell provides a protective barrier that controls the release of these substances[1].
Topical Application
- The formulations are intended for topical application, which includes but is not limited to skin treatments, wound care, and cosmetic applications. The stability provided by the core-shell microcapsules ensures that the active ingredients remain effective over a longer period[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 typically describes the broadest aspect of the invention, which includes the composition of the topical formulation with core-shell microcapsules.
- Subsequent claims may narrow down the scope by specifying particular materials, methods of preparation, or specific applications[1].
Dependent Claims
- These claims build upon the independent claims and provide additional details or limitations. For example, a dependent claim might specify the type of polymer used for the shell or the method of encapsulating the active ingredient[1].
Key Components and Materials
The patent highlights several key components and materials:
Active Ingredients
- Substances like benzoyl peroxide are mentioned as potential active ingredients. These ingredients are encapsulated within the core of the microcapsules to ensure their stability and controlled release[1].
Shell Materials
- The shell of the microcapsules is typically made from polymers or other materials that provide a stable and protective barrier. The choice of material can affect the release profile of the active ingredients[1].
Method of Preparation
The patent also details the methods for preparing these stabilized topical formulations:
Encapsulation Process
- The process involves encapsulating the active ingredients within the core-shell microcapsules. This can be done through various techniques such as emulsion polymerization or solvent evaporation[1].
Formulation Steps
- The formulation steps include mixing the microcapsules with other components to create a stable emulsion suitable for topical application. This may involve adding emulsifiers, stabilizers, and other excipients[1].
Advantages and Benefits
The use of core-shell microcapsules in topical formulations offers several advantages:
Stability
- The microcapsules provide a stable environment for the active ingredients, protecting them from degradation and ensuring their efficacy over time[1].
Controlled Release
- The shell of the microcapsules can be designed to control the release of the active ingredients, providing a sustained delivery that enhances the therapeutic or cosmetic effect[1].
Skin Penetration
- The formulation can be optimized to improve skin penetration, ensuring that the active ingredients reach the target site effectively[1].
Patent Landscape and Implications
Understanding the patent landscape is crucial for companies and researchers working in this field:
Competitive Advantage
- Holding a patent like US 12,053,546 provides a significant competitive advantage, as it protects the unique formulation and method of preparation from being replicated by competitors[1].
Licensing and Collaboration
- The patent can be licensed to other companies, allowing for broader application and commercialization of the technology. This can also facilitate collaborations and partnerships in the development of new products[4].
Litigation and Enforcement
- The patent holder has the right to enforce the patent against any infringers. This involves monitoring for unauthorized use and taking legal action if necessary. The validity of the patent can be presumed under 35 USC 282, but it can still be challenged through various legal proceedings[5].
Future Developments and Trends
The field of microcapsule technology is continuously evolving:
Advancements in Materials
- Research is ongoing to develop new materials for the shell of the microcapsules that offer improved stability, biocompatibility, and controlled release profiles[1].
Expanded Applications
- The technology is being explored for a wider range of applications, including drug delivery systems, wound care, and advanced cosmetic treatments[1].
Key Takeaways
- Core-Shell Microcapsules: The patent introduces the use of core-shell microcapsules to stabilize and enhance the delivery of active ingredients in topical formulations.
- Stability and Controlled Release: The microcapsules provide a stable environment and controlled release of active ingredients, improving the efficacy of topical applications.
- Broad Applications: The technology has potential applications in pharmaceuticals, cosmetics, and other fields requiring topical treatments.
- Competitive Advantage: The patent offers a competitive advantage to the holder and can be licensed or used for collaborations.
- Future Developments: Ongoing research aims to improve materials and expand applications of microcapsule technology.
Frequently Asked Questions (FAQs)
What is the main innovation of US Patent 12,053,546?
The main innovation is the use of core-shell microcapsules to stabilize and enhance the delivery of active ingredients in topical formulations.
What are the key components of the core-shell microcapsules?
The key components include the core, which contains the active ingredient (e.g., benzoyl peroxide), and the shell, which is typically made of a polymer material.
How do core-shell microcapsules improve topical formulations?
They improve stability, provide controlled release of active ingredients, and enhance skin penetration.
What are the potential applications of this technology?
The technology has potential applications in pharmaceuticals, cosmetics, wound care, and other fields requiring topical treatments.
How does the patent protect the invention?
The patent protects the unique formulation and method of preparation, providing a competitive advantage and the right to enforce against infringers.
Cited Sources
- US Patent and Trademark Office, "Stabilized topical formulations containing core-shell microcapsules," US12053546B2.
- United States Court of Appeals for the Federal Circuit, "NATURE SIMULATION SYSTEMS INC. v. AUTODESK, INC.," 20-2257.OPINION.10-17-2022.
- United States Patent and Trademark Office, "Patent Claims Research Dataset."
- Government Accountability Office, "Assessing Factors That Affect Patent Infringement Litigation Could Help Improve Patent Quality."
- United States Code, "35 USC 282: Presumption of validity; defenses."
