The non-FINAL rejection mailed on 10/22/2025 is herewith WITHRAWN.
DETAILED ACTION
Claims 1-2, 4-13 are currently pending and are examined on the merits herein.
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 .
Application Priority
This application filed 05/16/2023 is a 371 of PCT/EP2021/082742 filed on 11/24/2021 which has PRO 63/118,036 filed on 11/25/2020.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 10/22/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
The following rejections are made:
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.
Claims 1-2, 4-8, 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Merck (Banamine Transdermal/Product Information - 2017, Intervet Inc., a subsidiary of Merck & Co., 5 pages - IDS) in view of Skolnick et al. (US 20080014272 A1).
Merck teaches in each milliliter of Banamine Transdermal pour-on contains 50 mg flunixin (equivalent to 83 mg flunixin meglumine), 150 mg 2-pyrrolidone, 50 mg L-menthol, 500 mg propylene glycol dicaprylate/dicaprate NF, 0.20 mg FD&C Red No. 40, and glycerol monocaprylate NF qs. (see DESCRIPTION). The reference teaches the pour-on formulation is useful in control of pyrexia, mastitis, control of pain, in beef cattle and dairy cattle.
While Merck teaches a transdermal pour-on formulation, the reference does not specify a buccal form.
Skolnick et al. teaches treatment of chronic pain conditions and the administration of a first drug, bicifadine, in combination with an NSAID such as the aminonicotinic acid, flunixin to an animal subject, including, but are not limited to, human and other mammalian subjects suffering from chronic pain. [0020] Suitable routes of administration for delivering bicifadine and one or more NSAID(s) include, but are not limited to, oral, buccal, nasal, aerosol, topical, transdermal, mucosal, injectable, slow release, controlled release, iontophoresis, sonophoresis, and other conventional delivery routes, devices and methods. [0107]
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange routes of administration. The motivation to interchange routes of administration is because Skolnick et al. teaches suitable routes of administration for delivering bicifadine and flunixin include oral, buccal, topical, and transdermal. [0107] A skilled artisan would have reasonable expectation of successfully administering the flunixin in an oral, buccal, topical, or transdermal form.
Claims 9-10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Merck (Banamine Transdermal/Product Information - 2017, Intervet Inc., a subsidiary of Merck & Co., 5 pages - IDS) in view of Skolnick et al. (US 20080014272 A1), as applied to claims 1-2, 4-8, and 11-12 above, and further in view of Olson (WO 2017199181 A1).
Merck and Skolnick et al. as applied above.
Merck and Skolnick et al. do not teach the castration or tail docking of an animal.
Olson teaches treatment of animals in pain associated with castration and tail docking. [0001] Castration and tail docking of piglets is a common management practice on commercial swine farms [0002]. The reference teaches a method of treating an animal for pain comprising administering a topical composition comprising an effective dose of a local anesthetic and an analgesic – such as flunixin. (see claim 3)
It would have been obvious to one of ordinary skill in the art at the time of filing to treat pain associated with castration and tail docking of pigs. The motivation to treat pain associated with castration and tail docking of pigs is because Olson teaches treatment of animals in pain associated with castration and tail docking pain comprising administering a topical composition comprising an effective dose of a local anesthetic and an analgesic – such as flunixin. (claim 3) A skilled artisan would have reasonable expectation of successfully administering the flunixin to pigs treating in pain associated with castration and tail docking pain.
Conclusion
No claims allowed.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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