United States Patent 10,857,096: A Detailed Analysis of Scope and Claims
Overview of the Patent
United States Patent 10,857,096, titled "Compositions and methods for ophthalmic and/or other applications," pertains to innovative particles, compositions, and methods designed to enhance particle transport in mucus. This patent is crucial in the field of ophthalmology and other medical applications where mucus presents a barrier to drug delivery.
Background and Context
The patent addresses a significant challenge in ophthalmic drug delivery: the presence of mucus in the eye that can hinder the effectiveness of treatments. By developing particles and compositions that can navigate through mucus efficiently, this invention aims to improve the efficacy of ophthalmic treatments[1].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. Here are some key aspects:
-
Particles and Compositions: The patent describes specific particles and compositions that are designed to interact with mucus in a way that facilitates their transport. These particles may have particular sizes, shapes, and surface properties that enhance their mobility through mucus[1].
-
Methods of Use: The patent outlines methods for using these particles and compositions in ophthalmic and other applications. This includes procedures for administering the particles, the dosage forms, and the expected outcomes[1].
-
Mucus-Penetrating Properties: A critical aspect of the patent is the mucus-penetrating properties of the particles. These properties are achieved through specific design elements, such as the use of certain polymers or surface coatings that reduce adhesion to mucus[1].
Technological Field
The patent falls under the broader category of biomedical engineering and pharmaceuticals, specifically within the realm of ophthalmic drug delivery. It aligns with the World Intellectual Property Organization (WIPO) classification for medical and pharmaceutical inventions[4].
Key Components of the Invention
Particle Design
The particles described in the patent are engineered to have specific characteristics that enable them to penetrate mucus effectively. This includes:
-
Size and Shape: The particles are designed to be of a particular size and shape that allows them to move through the mucus layer without getting trapped[1].
-
Surface Properties: The surface properties of the particles, such as charge and hydrophobicity, are tailored to reduce interaction with mucus components, thereby enhancing their transport[1].
Compositions
The patent also covers various compositions that incorporate these particles. These compositions can be formulated as eye drops, gels, or other ophthalmic delivery systems. The compositions are designed to maintain the stability and efficacy of the particles during storage and administration[1].
Methods of Administration
The methods of administration are a crucial part of the patent. These methods include detailed protocols for how the particles and compositions should be applied to ensure optimal delivery and efficacy. This may involve specific dosing regimens and application techniques[1].
Patent Landscape
Related Patents and Technologies
The patent landscape in the field of ophthalmic drug delivery is highly competitive and innovative. Other patents and technologies focus on similar challenges, such as improving drug delivery through the use of nanotechnology, bioadhesive systems, and targeted drug delivery mechanisms[4].
Competitive Advantage
The unique design of the particles and compositions in this patent provides a competitive advantage by offering improved mucus-penetrating capabilities. This can lead to better treatment outcomes and patient compliance compared to existing technologies[1].
Economic and Commercial Implications
Market Potential
The market potential for this patent is significant, given the growing demand for effective ophthalmic treatments. The ability to enhance drug delivery through mucus can open up new avenues for treating a range of eye conditions, from dry eye syndrome to more severe diseases like glaucoma and age-related macular degeneration[4].
Cost and Commercialization
The commercialization of this patent involves significant costs, including the development of the particles and compositions, clinical trials, and regulatory approvals. However, the potential return on investment is high, especially if the technology can be licensed to major pharmaceutical companies or used in-house to develop new products[5].
Legal and Regulatory Aspects
Patent Prosecution
The process of obtaining this patent would have involved a detailed examination by the USPTO to ensure that the invention meets the criteria of novelty, nonobviousness, and utility. Any challenges or rejections during the prosecution process would have required amendments and arguments to be presented to the patent examiner[5].
International Protection
For global protection, the inventors might consider filing an international patent application under the Patent Cooperation Treaty (PCT), which allows for the preservation of rights to file in multiple countries within a specified timeframe[5].
Key Takeaways
- Innovative Particle Design: The patent introduces particles with specific properties that enhance their transport through mucus.
- Compositions and Methods: Detailed compositions and methods of administration are provided to ensure optimal delivery.
- Market Potential: The technology has significant market potential in the ophthalmic drug delivery sector.
- Commercialization Challenges: Commercialization involves substantial costs but offers high potential returns.
- Legal and Regulatory Compliance: The patent would have undergone rigorous examination and may require international protection through PCT.
FAQs
What is the primary challenge addressed by this patent?
The primary challenge addressed by this patent is the difficulty of delivering drugs through the mucus layer in the eye, which hinders the efficacy of ophthalmic treatments.
How do the particles described in the patent overcome this challenge?
The particles are designed with specific sizes, shapes, and surface properties that reduce their interaction with mucus, allowing them to penetrate more effectively.
What are the potential applications of this technology?
The technology has potential applications in treating various ophthalmic conditions, including dry eye syndrome, glaucoma, and age-related macular degeneration.
What is the significance of the mucus-penetrating properties of the particles?
The mucus-penetrating properties are crucial as they enable the particles to reach the target site in the eye more efficiently, improving the overall efficacy of the treatment.
How does the commercialization process for this patent differ from other pharmaceutical inventions?
The commercialization process involves significant costs related to development, clinical trials, and regulatory approvals, but the potential return on investment is high due to the innovative nature of the technology.
Sources
- US10857096B2 - Compositions and methods for ophthalmic and/or other applications - Google Patents
- AI VISUALIZE, INC. v. NUANCE COMMUNICATIONS, INC. - CAFC
- Patent Claims Research Dataset - USPTO
- Invention: U.S. and Comparative Global Trends - NCSES
- Intellectual Property Protection - KU Office of Research
