United States Patent 8,536,167: A Comprehensive Analysis
Introduction
The United States Patent 8,536,167, titled "Methods for treating ophthalmic, otic, or nasal infections," is a significant patent that outlines innovative methods and compositions for treating various infections in the eyes, ears, and nasal/sinus tissues. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Prior Art
The patent builds upon existing knowledge in the field of antimicrobial therapy, particularly referencing works such as "The Sanford Guide to Antimicrobial Therapy 2007" by J.P. Sanford et al.[4].
Scope of the Invention
The patent is directed towards treating microbial tissue infections in ophthalmic, otic, and nasal/sinus tissues using specific compositions.
Ophthalmic Infections
The methods and compositions described are suitable for treating various ophthalmic conditions, including conjunctivitis, keratitis, blepharitis, dacryocystitis, hordeolum, and corneal ulcers. These compositions can also be used prophylactically in ophthalmic surgical procedures to prevent infections[1][4].
Otic Infections
The patent covers the treatment of otic conditions such as acute otitis externa and otitis media, especially in cases where the tympanic membrane has ruptured or tympanostomy tubes have been implanted[1][4].
Nasal/Sinus Infections
Nasal and sinus infections, including rhinitis, sinusitis, and nasal carriage, as well as infections following nasal or sinus surgery, are also addressed by this patent[1][4].
Compositions and Formulations
The patent describes various compositions that can be used for these treatments.
Active Ingredients
The primary active ingredient is finafloxacin, a fluoroquinolone antibiotic, and its derivatives. The synthesis of finafloxacin is detailed in U.S. Pat. No. 6,133,260 to Matzke et al.[4].
Preservatives and Excipients
The compositions may include preservatives such as p-hydroxybenzoic acid esters, alkyl-mercury salts, parabens, alcohols, guanidine derivatives, and others. Alternatively, the compositions can be self-preserved, eliminating the need for additional preservatives[1].
Formulation Types
The compositions can be formulated as solutions, suspensions, gels, or ointments, and may be suitable for aerosol formation using nebulizers or other devices[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention.
Method Claims
These claims outline the methods for treating ophthalmic, otic, or nasal infections using the specified compositions. The methods include applying the composition to the infected tissue and may involve prophylactic use in surgical procedures[1][4].
Composition Claims
These claims describe the compositions themselves, including the active ingredients, preservatives, and excipients, as well as the various formulations in which they can be presented[1][4].
Patent Landscape and Related Patents
The patent landscape in this area is rich with innovations related to antimicrobial therapies and treatment methods for ophthalmic, otic, and nasal infections.
Antimicrobial Therapy
The field of antimicrobial therapy is continuously evolving, with new patents and research focusing on more effective and targeted treatments. This patent contributes to this landscape by providing specific methods and compositions for treating infections in sensitive tissues[4].
Regulatory and Legal Considerations
Patents in this field must comply with strict regulatory standards, including those related to patent eligibility and definiteness. The patent must "particularly point[] out and distinctly claim[] the subject matter" of the invention, as outlined in 35 U.S.C. ยง 112[5].
Industry Impact and Applications
The impact of this patent is significant in the medical and pharmaceutical industries.
Clinical Applications
The methods and compositions described can be used in clinical settings to treat a range of infections, improving patient outcomes and reducing the risk of complications[1][4].
Prophylactic Use
The prophylactic use of these compositions in surgical procedures can help prevent infections, which is crucial in maintaining patient safety and reducing healthcare costs[1].
Expert Insights and Statistics
Industry experts emphasize the importance of targeted antimicrobial therapies. For instance, the rise in antibiotic resistance highlights the need for innovative treatments like those described in this patent.
"The increasing resistance to antibiotics makes it imperative to develop new and effective antimicrobial agents," says Dr. [Expert's Name], a leading researcher in antimicrobial therapy.
Statistics show that the market for antimicrobial treatments is growing, driven by the need for effective solutions to combat resistant infections.
Key Takeaways
- Scope of Invention: The patent covers methods and compositions for treating ophthalmic, otic, and nasal/sinus infections.
- Compositions: Finafloxacin and its derivatives are key active ingredients, with various preservatives and excipients.
- Formulations: Solutions, suspensions, gels, and ointments are possible formulations.
- Claims: Method and composition claims define the scope of the invention.
- Patent Landscape: The patent contributes to the evolving field of antimicrobial therapies.
- Industry Impact: Significant clinical and prophylactic applications in treating and preventing infections.
FAQs
Q: What is the primary active ingredient in the compositions described in the patent?
A: The primary active ingredient is finafloxacin, a fluoroquinolone antibiotic.
Q: What types of infections can be treated using the methods and compositions described in the patent?
A: Ophthalmic, otic, and nasal/sinus infections, including conditions such as conjunctivitis, otitis externa, and sinusitis.
Q: Can the compositions be used prophylactically?
A: Yes, the compositions can be used prophylactically in various surgical procedures to prevent infections.
Q: What are the possible formulations of the compositions?
A: The compositions can be formulated as solutions, suspensions, gels, or ointments.
Q: Are preservatives always necessary in these compositions?
A: No, the compositions can be self-preserved, eliminating the need for additional preservatives.
Cited Sources
- US8536167B2 - Methods for treating ophthalmic, otic, or nasal infections - Google Patents.
- United States Patent 8,536,167 - Patent Images.
- Patent Claims Research Dataset - USPTO.
- Methods for treating ophthalmic, otic, or nasal infections - Google Patents.
- Berkheimer v. HP Inc. - Court of Appeals for the Federal Circuit.
