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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/2/2026 has been entered.
Current Status of 17/795,652
This Office Action is responsive to the amended claims of 9/2/2026.
Claims 1-25 are examined on the merits. Claims 19-25 are new.
Priority
This application is a national state entry of PCT/EP2021/051891, which claims priority to US provisional application 62/967,281.
The instant claims find support from the US provisional application. Therefore, the effective filing date is 1/29/2020.
Response to Arguments
Applicants’ claim amendments and Remarks of 9/2/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
In regard to the 112(b) rejection, this rejection is withdrawn due to applicants amendments.
In regard to the obviousness rejection, this rejection is withdrawn. Applicants remarks with Examiner’s reply are summarized below:
Applicants submit that Hallenbach does not consider the solubility of the active ingredient, which is important in how the composition is used.
The specification teaches a dermally applicable liquid formulation of an antiparasitic active compound on mammals and livestock. Avoiding the composition dripping off the animal’s skin is an important aspect of the invention (page 1 lines 10-13 of the specification).
Having a high level of solubility of the active ingredient (so it can be dissolved at an effective concentration and in a low volume) directly addresses the problem of dripping off the animal’s skin.
Applicants further discuss the unexpected results.
After a review of figure of page 3 of the Remarks of 09/02/2026, Examiner better understands the meaning (i.e. desire to maximize this variable) of the spreading after application and how the most beneficial combination of solubility and good spreading characteristics can be achieved with the proportion of solvents of the instant claims.
The solvent proportions are criterial for providing a composition with high solubility and good spreading characteristics.
Neither of the references teach or suggest the solubility of active ingredients. A skilled artisan would not obtain any hints regarding the instant selection of solvents and the amount of solvents.
While this rejection is withdrawn, MPEP 716.02 states that unexpected results must be commensurate in scope with the claimed invention. Table 7/the figure on page 24 of the remarks does not cover the whole scope of base claim 1; it is directed to compound I-1, IPA, and PPC). Therefore, there are other obviousness rejections (with other combinations of solvents) to be made.
Response to Amendment
Claim Objections
Claim 20 is objected to because of the following informalities: New claim 20 looks like it contains a random circle above the R1, depicted here
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. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-3, 5-7, and 9-23 are rejected under 35 U.S.C. 103 as being unpatentable over HALLENBACH (WO 2015/067646 A1), which has been cited in the IDS of 7/27/2022, in view of EVA (Eva Krudewagen et al., “Chemical Compatibility and Safety of Imidacloprid/Flumethrin Collar Concomitantly Used with with Imidacloprid/Moxidectin (Advocate®, Advantage® Multi) and Emodepside/Praziquantel (Profender®) Spot-on Formulations”, Parastill Res, 2015).
HALLENBACH teaches the elected compound referred to as I-T3-99 on page 231. This helps teach claims 9-10 and claim 23.
HALLENBACH teaches a liquid composition of this compound (paragraph [0213], page 59 of the machine translation). HALLENBACH teaches this as a pharmaceutical composition administered to mammals (paragraph [0283], and page 80 of the machine translation).
HALLENBACH teaches diluents such as alcohols such as methanol, ethanol, butanol and glycol ether (paragraph [0432], and page 107 of the machine translation). This helps teach claims 1-2, and 6-7 (glycol ether).
HALLENBACH teaches that the pharmaceutically active ingredient is present in amount greater than or equal to 0.1% by weight and less than or equal to 5% by weight (paragraph [0230], and page 62 of the machine translation). This helps teach claim 11, 16-17. Note, Claim 1 does not require a percentage of active ingredient.
HALLENBACH teaches a method of using the pharmaceutical composition for treating ectoparasite infestation (paragraph [0279], and page 79 of machine translation). This teaches claim 13. HALLENBACH teaches the pharmaceutical composition can treat parasite infection for animals (paragraph [0280], and page 79 of machine translation). This teaches claims 12 and 14. HALLENBACH teaches that the pharmaceutical composition is dripped or poured onto the non-human organism (paragraph [0212], and page 59 of machine translation). This teaches claim 15.
While HALLENBACH teaches the claims above, HALLENBACH does not teach propylene carbonate or benzyl alcohol as a solvent or solubility of the active ingredient.
HALLENBACH does not teach spot on formulations.
EVA teaches anti-parasitic formulations (flea and tick treatments such as imidacloprid, which is another halogenated nitrogen-containing heterocyclic compound) (S56). Spot on formulations focus on the spreading/delivering the active ingredients to animals (S75-S76). This helps teach claims 13-14, 19 (dripping or pouring spot on formulations).
EVA also teaches solvents in the spot-on formulations, one common combination is Benzyl alcohol (BA) and propylene carbonate (PC) in an 80:20 ratio (table 1; also used in the Advantage®, Advocate® products). EVA’s solvents are used in commercial products available for dog owners (table 1). This teaches the solvents of claims 1, 3, 5, and 18.
EVA teaches the active ingredients for this product ranged from 4.5-10wt% (page S56). This helps teach claims 16 and 17.
The artisan would have been motivated to use solvents (such as in EVA) since both products are used for the same (anti-parasitic spot on formulations treating animals). EVA’s solvents are used in commercial products available for dog owners (table 1). The artisan would have been motivated to substitute the active ingredient (imidacloprid) in EVA with HALLENBACH’s compound since both are halogenated nitrogen-containing heterocyclic compounds that are known to have anti-parasitic properties. The artisan would have expected to substitute one anti-parasitic compound for another and expected them to behave similarly. See MPEP 2144.06.II.
The artisan would have been motivated to optimize the weight percentages of I-T3-99, Benzyl alcohol, and propylene carbonate (HALLENBACH paragraph [0230]; EVA table 1). See MPEP 2144.05 (II)(A): “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical”. Neither the specification nor the claims indicate the weight percentages of the components in the instant claims is critical. This teaches claims 1-3, 5-7, and 9-23.
Conclusion
Claims 4, 8, 24, and 25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
