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 .
Current Status of 17/795,652
This Office Action is responsive to the claims of 1/29/2026.
Claims 1-18 are examined on the merits.
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 1/29/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
The 112(b) rejection is withdrawn due to applicants amendments.
In regard to the 103 rejection, this rejection is maintained. Applicants remarks with Examiner’s reply are summarized below:
Applicants submit that nothing in Hallenbach would guide a skilled person to arrive at the composition of instant claims.
Applicants submit that the solvents of Hallenbach and Dupont are incompatible because Hallenbach suggests using a combination of solvents only when one of the solvents is water; Dupont does not teach water as a solvent.
Examiner has reviewed both references again. Hallenbach does not restrict solvents, and Dupont does allow for water (“In addition, the compositions may comprise strong polar solvents, such as N-methyl-2-pyrrolidone, dimethyl sulfoxide or dimethylformamide, or water”, on page 26)
Applicants submit that the weight percentages of the components in the claims are critical for solubility of the active ingredient.
Examiner as reviewed page 7 lines 14-16 of the specification, and disagrees. The specification uses the phrases “good spreading characteristics” and “particularly effectively”. There is no p value or statistical values proving criticality. These phrases also do not imply or prove criticality.
Applicants submit table 1 and show synergistic effects for spreading properties. The solvent proportions are criterial for providing a composition with high solubility and good spreading characteristics.
Examiner has reviewed table 1 and 7 from the specification. Table 1 shows solvent mixtures and their temperatures and the saturation concentration. Table 7 shows a number of formulations, rations of IPA to PPC, Volume, hair length, surface temperature, Area at time=0, and area at time=1. Its not clear what the y axis is on the graph on page 18 of the Remarks. Additionally, Examiner is unsure how Applicants placed the box denoting the unexpected results.
Though Applicant states that unexpected results have been achieved, the instant specification does not provide any unexpected or surprising results. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See MPEP 716.01(c).
MPEP 716.02 states that unexpected results a) are greater than expected results, b) show superiority of a property shared with the prior art, c) exhibit the presence of an unexpected property, and/or d) exhibit the absence of an expected property. MPEP 716.02 additionally states that unexpected results must be commensurate in scope with the claimed invention and provide a comparison with the closest prior art.
Response to Amendment
Claim Rejections - 35 USC § 112
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 15, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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) 1-18 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 DUPONT (WO 2014/096381 A1), which has been cited in the IDS of 7/27/2022.
HALLENBACH teaches the elected compound referred to as I-T3-99 on page 231. This helps teach claims 9-10.
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, isopropanol, butanol and glycol ether (paragraph [0432], and page 107 of the machine translation). This helps teach claims 1-2, 4 (Isopropanol), 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.
However, 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 as a solvent.
DUPONT teaches a spray-on antiparasitic (ectoparasites) topical formulation comprising isopropanol and propylene carbonate (page 37, paragraph 2). This helps teach claims 3-5 and 18.
DUPONT teaches a pour-on or spot-on formulation generally contains 1 to 98.9 % by weight of a compound of formula (I), 0.1 to 80 % by weight of dispersing agent and 1 to 98.9 % by weight of solvent (page 28).
The artisan would have found it obvious to use one spray-on antiparasitic topical formulation containing isopropanol and propylene carbonate and use it to deliver the active compound from HALLENBACH (I-T3-99 on page 231). The artisan would expect that the formulation would retain the properties of I-T3-99.
The artisan would have been motivated to optimize the weight percentages of I-T3-99, isopropanol, and propylene carbonate (HALLENBACH paragraph [0230]; DUPONT page 28). 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 1-17.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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