DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement filed 10/21/24 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
It is noted that NPL references 1, 2, and 5 were not received. However, applicants did submit an 18 page document: “Freedom of Information Summary – original new animal drug application, NADA 141-266, POSATEX otic solution”;
A 7 page document: NOAH Compendium regarding Neptra;
A 2 page document: European Medicines Agency Science Medicines Health regarding Neptra; and,
A 3 page document: European Medicines Agency Science Medicines Health regarding Osurnia.
These do not appear to match any of the three lined-through references from the IDS filed 10/21/24.
Also – NPL reference 2 on the IDS filed 7/13/26 was not received and applicants submitted a document having the title:
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which is not in English nor does not appear to be on the IDS filed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Merk Animal Health, Mometamax Otic Suspension, Merk Animal Health, Intervet Inc. (hereinafter Merk), pp 1-4 2016 – NPL reference 1 from applicant’s IDs filed 3/23/26 in view of Intervet, Inc., Freedom of Information Summary – original new animal drug application, NADA 141-266, POSATEX otic solution, approved 2/18/2010 (hereinafter Intervet) - which was supplied by applicants 10/21/24.
The claims of the present application are drawn to compositions comprising: an antibiotic being gentamicin or gentamicin sulfate; an anti-inflammatory agent being mometasone or mometasone furoate monohydrate; an antifungal being posaconazole; and a pharmaceutically acceptable carrier such as mineral oil. The dosages are limited to various amounts; and the composition is limited to additionally containing a thickening agent which is optionally a plasticized hydrocarbon gel. As claimed are methods of treating an otic infection with the same comprising administering the composition once wherein the patient is optionally a dog or a cat. The infection is limited to various infections agents. Also claimed is a container containing multiple doses of the composition.
Merk discloses a composition comprising gentamicin sulfate, mometasone furoate monohydrate and clotrimazole as an otic composition for use in dogs to treat pets for various ear infections such as Malassezia pachydermatis (see bottom of page 1). The composition is taught to comprise per gram of composition: 3mg gentamicin, 1mg mometasone, 10mg clotrimazole, in a mineral oil-based system containing plasticized hydrocarbon gel (see “description”). What is not taught is to add posaconazole as the antifungal agent instead of the clotrimazole used by Merk’s composition.
Intervet discloses an otic suspension for dogs for treating various strains of yeast such as Malassezia pachydermatis and various bacteria (see 1st page). The compositions of Intervet comprise: the antibiotic orbifloxacin, the anti-inflammatory agent mometasone furoate monohydrate, and the antifungal agent posaconazole. The compositions are taught to comprise a vehicle which is mineral oil and plasticized hydrocarbon gel (see page 14).
It would have been obvious to one of skill in the art at the time of the invention to modify the compositions of the art which comprise either antibiotic: gentamicin or orbifloxacin; mometasone furoate monohydrate; and either antifungal posconazole or clotrimazole to arrive at the present composition comprising gentamicin, mometasone, and posconazole. The art teaches the use of triple combination compositions containing anti-inflammatory, antifungal and antibacterial agents for use in treating otitis media in animals. The art teaches the use of the same agents to be used in different triple combination compositions. It would have been obvious to modify, or combine the agents to make a new composition having the very same purpose. Applicants have shown their compositions when administered in a single dose achieve similar results to the arts compositions which require multiple doses. However, if applicants are relying on unexpected results, the results should be commensurate in scope with that which is being claimed. Applicants have tested only 1 composition having concentrations of 0.86% w/v gentamicin; 0.21% w/v mometasone furoate monohydrate; and 0.26% w/v posaconazole. This showing of properties of the compositions having only 1 dosage of each of the agents is not seen to be sufficient to show unexpected results across the dosages being claimed herein.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693
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