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 .
DETAILED ACTION
Claims 1-20 are pending in the instant application.
Claims 2, 4-7, 12, 15, and 20 are cancelled.
Claims 26-33 are new.
Claims 1, 3, 8-11, 13-14, 16-19, and 26-33 are examined herein.
Priority
The instant application claims benefit of foreign priority to AU2019903522, filed on 23 September 2019, and the benefit of priority to PCT/AU2020/051003, filed on 28 September 2020. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 23 September 2019.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 22 March 2022, 27 October 2023, 15 March 2024, and 16 October 2024, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 11 August 2025 has been entered.
In view of applicant cancellation of claim 12, the objection of record is withdrawn.
In view of applicant amendment to claim 1, the 112(a)-written description rejection of record is withdrawn.
In view of applicant amendment to claim 1, the 112(b) rejection of record is withdrawn.
In view of applicant amendment to claim 1, the 102(a)(1) rejections of record, over Mastroianni and Su, are both withdrawn.
In view of applicant amendment to claim 1, the 103 rejections of record are withdrawn.
In addition, new 103 rejections are necessitated by amendment (see below).
All rejections and objections not found below have been withdrawn.
NEW REJECTIONS FACILIITATED BY AMENDMENT
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, 3, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Ahlstrom et al. (The Veterinary Journal.2013; 196: 456–460) in view of Ihrke et al. (World Small Animal Veterinary Association World Congress Proceedings. How I Treat Flea Allergy Dermatitis in 2008. 2008) and Schalau et al. (Dow Corning Corporation. Recent Developments on Silicones in Topical and Transdermal Drug Delivery. 2017).
Regarding claim 1, Ahlstrom teaches the method of treating allergic skin disease in dogs comprising administering topically applied glucocorticoids (Introduction). Ahlstrom teaches three budesonide formulations in pharmaceutically acceptable carriers. Ahlstrom emphasizes the need for topical compositions to be formulated such that skin penetration and retention of the budesonide is maximized.
Ahlstrom does not teach the addition of permethrin to the budesonide composition nor is a silicone excipient explicitly taught (excipients in Barazone® are unknown).
Ihrke teaches treating allergic dermatitis in dogs comprising a composition of imidacloprid and permethrin. Ihrke outlines the advantage of permethrin is its ability to repel insects.
Ihrke does not teach the excipients in the composition of imidacloprid and permethrin.
Schalau teaches the use of silicone excipients in topical formulations to improve drug delivery efficacy.
As Ahlstrom discusses the importance of budesonide formulations to increase the drugs contact time with the skin it would be obvious to one of ordinary skill in the art to formulate the budesonide containing composition with a silicone excipient as Schalau teaches the improved drug deliver properties of silicone excipients. The compositions taught by Ahlstrom would treat allergic dermatitis by treating the immune response to the allergy, however it would not repel the cause of the allergy, namely, an insect. Irhke teaches the advantage of particular allergic dermatitis treating composition is its concentration of permethrin, as permethrin repels the cause of the allergic dermatitis. It would be prima facie obvious to one of ordinary skill in the art to add permethrin to the composition taught by Ahlstrom to repel the cause of the allergic skin condition. Further adding the silicone excipient, as taught by Schalau, to improve drug delivery would result in the instant invention.
Regarding claim 3, Shalau teaches cyclomethicone, also known as cyclotetrasiloxane, as one of the most widely used silicone excipients in topical drug delivery systems (page 2).
Regarding claims 8 and 26, Ahlstrom teaches the concentration of budesonide to be 0.25 mg/mL, or 0.25 g/L, which overlaps with the instant recitation (page 457).
Claim(s) 1, 3, 8-11, 13-14, 17-19, and 26-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahlstrom et al. (cited above) in view of Ihrke et al. (cited above and Schalau et al. (cited above) in further view of Kieran et al. (US4607050A).
The teachings of Ahlstrom, Irke, and Schalau are disclosed above and incorporated by reference herein.
Regarding claim 9, the combined teachings do not teach a concentration of 10 g/L to 60 g/L of permethrin, or up to 5% w/w. Rather Irkhe teaches the concentration of permethrin to be 44% by weight.
Kieran teaches a method of controlling insects or parasites on an animal comprising administering an insecticidal agent (claim 1), such as permethrin (claim 8), at a concentration of 10 g/L (column 6, line 23).
Additionally Kieran teaches adding silicone excipients (column 6, line 25) to the topical pour-on formulation.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong B of KSR applies – substitution of one known element for another. Substituting the taught concentration of permethrin by Ihrke for that taught by Kieran would be obvious to one of ordinary skill in the art as the adjustment of the concentration of insecticide would be routine optimization.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Regarding claims 10, in the absence of criticality, the ratio of corticosteroid to insecticide would be routine optimization. See MPEP 2144.05.II.A.
Regarding claims 11 and 28, Kieran teaches a silicone excipient at 10 g/L. This concentration would be expected to be optimized based on the desired formulation. Topical administration requires a formulation with low surface tension, increasing the silicone excipient would reduce the surface tension and produce a formulation that could be spread topically. Therefore, in the absence of criticality, the concentration would be routine optimization. See MPEP 2144.05.II.A.
Regarding claim 13, taking the teaching of Ahlstrom and adding permethrin, under the teaching of Ihrke, and a silicone excipient, under the teaching of Schalau and Kieran, and substituting the concentration of Ihrke’s permethrin for that of Kieran would result in the instant invention. The reasons for obviousness are addressed above. Additionally Kieran teaches water as the carrier.
Regarding claim 14, Kieran teaches a thickening agent, propylene glycol, at 60 g/L (column 6, line 27). Adjustment of this concentration would be expected based on the desired formulation and would be considered routine optimization.
Regarding claims 17 and 18, Ahlestrom teaches the composition Barazone, a leave-in conditioner.
Regarding claims 17 and 19, Kieran teaches topical pour-on formulation.
Regarding claim 27, Kieran teaches the permethrin concentration at 10 g/L. This concentration would be expected to be optimized based on the desired formulation. In the absence of criticality, the concentration would be routine optimization. See MPEP 2144.05.II.A.
Regarding claims 29 and 30, Ahlstrom and Ihrke teach the treatment of dogs.
Regarding claim 31 and 32, Kieran teaches the administration to horses (column 5). As Keiran teaches a topical application this would include application to the coat or skin of the backline, mane area, tail area, dorsal midline, ears, head or ventral area.
Regarding claim 33, Ahlstrom teaches penetration testing on the thorax.
Claim(s) 1, 3, 8-11, 13-14, 16-19, and 26-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahlstrom et al. (cited above) in view of Ihrke et al. (cited above and Schalau et al. (cited above) in further view of Kieran et al. (US4607050A) and in further view of Jachowicz (Iscc Monograph. 2004: 1-295).
The teachings of Ahlstrom, Irke, Schalau, and Kieran are disclosed above and incorporated by reference herein.
Regarding claim 16, the combined teachings do not teach the thickening agent as a mixture of Polyquaternium-37, propylene glycol dicaprate dicaprylate and PPG-1 Trideceth-6.
Jachowicz teaches the above composition as an emulsifier and thickening agent in hair conditioners (page 224).
It would be prima facie obvious to one of ordinary skill to use the composition taught by Jachowicz as the thickening agent in a formulation for a leave-in conditioner.
Conclusion
Claim(s) 1, 3, 8-11, 13-14, 16-19, and 26-33 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621