United States Patent 6,559,183: A Detailed Analysis of Scope and Claims
Overview of the Patent
United States Patent 6,559,183, titled "Nano-emulsion of 5-aminolevulinic acid," is a significant patent in the field of medical science, particularly in the area of dermatological and oncological treatments. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape.
Background and Description
The patent, filed as US09/831,564 and granted on May 6, 2003, pertains to a composition comprising a nano-emulsion that contains 5-aminolevulinic acid (ALA) as the active substance. ALA is a precursor in the biosynthesis of porphyrins and is used in photodynamic therapy (PDT) for treating various skin conditions and certain types of cancer[1][4].
Scope of the Patent
Therapeutic Applications
The patent covers the use of ALA nano-emulsions for several therapeutic applications, including:
- Actinic Keratosis: A condition characterized by small, rough, scaly patches on the skin that are caused by prolonged exposure to the sun.
- Basal Cell Carcinoma: A type of skin cancer.
- Anogenital Warts: Caused by the human papillomavirus (HPV).
- Vulvar Intraepithelial Neoplasia: A precancerous condition of the vulva[4].
Composition and Formulation
The nano-emulsion composition includes ALA as the active ingredient, a carrier in an aqueous phase, and optionally, emulsifying agents, adjuvants, and other additives. The formulation is designed to enhance the stability and bioavailability of ALA, making it more effective for photodynamic therapy[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention:
- Claim 1: A composition comprising a nano-emulsion containing 5-aminolevulinic acid and a carrier in an aqueous phase.
- Claim 10: A method for treating a disease using the nano-emulsion composition, where the disease is selected from the group consisting of actinic keratosis, basal cell carcinoma, anogenital warts, and vulvar intraepithelial neoplasia[4].
Dependent Claims
Dependent claims further specify the composition and method of use, including the concentration of ALA, the type of emulsifying agents used, and the method of administration.
Patent Landscape
Related Patents and Technologies
The patent landscape surrounding US6559183B1 includes other patents related to the use of ALA in photodynamic therapy and nano-emulsion formulations. For example:
- Patent Analytics: Tools like those described by Schwegman’s ClaimScape® software help in analyzing and categorizing patents by claims and scope concepts, which can be crucial in understanding the competitive landscape and identifying gaps in patent coverage[3].
Expiration and Legal Status
The patent has expired, as indicated by its legal status. This means that the technology described in the patent is now in the public domain and can be freely used without infringing on the original patent rights[4].
Impact on Medical Treatments
Photodynamic Therapy
The use of ALA nano-emulsions in photodynamic therapy has significantly improved the treatment outcomes for various skin conditions and cancers. The enhanced bioavailability and stability of ALA in nano-emulsion form allow for more targeted and effective treatment[1][4].
Clinical Trials and Approval
The development and approval of this technology involved extensive clinical trials. The DrugBank entry for ALA indicates multiple clinical trials across various phases, highlighting the rigorous testing and validation process the drug underwent before approval[1].
Industry Expert Insights
Patent Strategy
Industry experts emphasize the importance of a well-structured patent strategy, including the use of claim charts and scope concepts to analyze and manage patent portfolios. This helps in identifying gaps in coverage and future design opportunities, as well as in navigating the complex landscape of patent claims and scope[3].
Regulatory Changes
Recent proposals by the USPTO, such as changes to terminal disclaimer practices, can significantly impact patent prosecution, licensing, and litigation strategies. These changes aim to promote competition and reduce barriers to market entry, which can affect how patents like US6559183B1 are managed and utilized in the future[5].
Key Takeaways
- Therapeutic Applications: The patent covers various therapeutic applications, including actinic keratosis, basal cell carcinoma, anogenital warts, and vulvar intraepithelial neoplasia.
- Nano-emulsion Composition: The composition includes ALA and a carrier in an aqueous phase, with optional emulsifying agents and adjuvants.
- Expired Patent: The patent has expired, making the technology publicly available.
- Impact on Treatments: The use of ALA nano-emulsions has improved treatment outcomes for several skin conditions and cancers.
- Patent Landscape: The patent is part of a broader landscape that includes other related patents and technologies, and is subject to ongoing regulatory changes.
FAQs
What is the primary use of 5-aminolevulinic acid (ALA) in the context of US6559183B1?
The primary use of ALA in this patent is for photodynamic therapy to treat skin conditions such as actinic keratosis, basal cell carcinoma, anogenital warts, and vulvar intraepithelial neoplasia.
What is the significance of the nano-emulsion formulation in this patent?
The nano-emulsion formulation enhances the stability and bioavailability of ALA, making it more effective for photodynamic therapy.
Has the patent US6559183B1 expired?
Yes, the patent has expired, which means the technology described is now in the public domain.
How does this patent fit into the broader patent landscape?
This patent is part of a larger landscape that includes other patents related to ALA and photodynamic therapy, and is subject to ongoing regulatory changes and patent analytics tools.
What are the implications of the USPTO's proposed changes to terminal disclaimer practices for patents like US6559183B1?
The proposed changes aim to promote competition and reduce barriers to market entry, which could impact how similar patents are prosecuted, licensed, and litigated in the future.
How can industry experts utilize tools like ClaimScape® to manage their patent portfolios?
Tools like ClaimScape® help in categorizing patents by claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities, making it easier to manage and analyze large numbers of patent claims.
Sources
- DrugBank: Aminolevulinic acid: Uses, Interactions, Mechanism of Action.
- USPTO: Patent Claims Research Dataset.
- Schwegman: Patent Analytics.
- Google Patents: US6559183B1 - Nano-emulsion of 5-aminolevulinic acid.
- Sterne Kessler: United States Patent and Trademark Office Proposes Changes to Terminal Disclaimer Practice.
