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 .
Applicants' arguments, filed July 17, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
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.
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, 5, 6, 8 and 10 – 14 were rejected under 35 U.S.C. 103 as being unpatentable over Reme et al. (Vet Dermat, 2004) in view of Paufique (WO 2017/121965; all citations from US 2019/0060390, the PGPub of the national stage entry as WO’965 was published in French) and Allart et al. (US 2005/0037035). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 16, 2026 and those set forth herein.
Presently canceled claim 15, previously rejected over Reme et al. in view of Paufique and Allart et al., recited that the animal was atopic and this limitation has been added to claim 1. Therefore the combination of applied prior art rendered obvious the claimed method for an animal with atopic dermatitis.
Applicants traverse this rejection on the grounds that the claimed method of using ALLERNYL® shampoo and lotion with an Ophiopogon japonicus outperforms the closest prior of Reme et al. with phytosphingosine at clinically meaningfully thresholds. Even accounting for the expectation that certain ingredients would be expected to reduce itching, this does not account for the obtained results. As the compositions were held constant, the markedly superior outcome is attributable to the claimed sequence and not the mere presence of an itch reducing ingredient. The expectation that an ingredient may soothe itching does not render the magnitude of the improvement predictable.
These arguments are unpersuasive. The deficiencies described on p 3 and 4 of the Office Action mailed April 16, 2026 have not been addressed as there is no direct comparison between the treatments and an indication as to what the expected results would be to determine if the observed differences were in fact unexpected. Arguments without factual support are mere allegations and are not found persuasive. Therefore the allegations of unexpected results remain insufficient to outweigh the prima facie case of obviousness.
Applicants also argue that White does not supply the missing teachings given that barrier characteristics of canine skin differ materially from those of human skin. White concerns washing with soap and water, which is not the same as the instant claims. White might suggest washing less frequently in general terms but does not teach the specific claim regimen.
These arguments are unpersuasive. White is not used as the basis of any rejection of record but as a reference aimed at providing some amount of information as what the expected results could be, which should be supplied by Applicants but was not (see MPEP 716.02(b)). No evidence in support of the statements regarding barrier function between humans and animals has been provided and what one of ordinary skill in the art would reasonably expect in light of their knowledge in determining what the expected results would be.
Applicants also argue that the method is not routine optimization and the evidence is commensurate in scope. The head-to-head comparison in Examples confirms that the effect is not the product of routine schedule optimization as an alternating schedule did not achieve the same effects with the claims limited to atopic animals.
These arguments are unpersuasive. As discussed above, without an indication as to what the expected results would, it cannot be determined if the obtained results were in fact unexpected. While the scope of claim 1 has been narrowed to atopic animals, the issue with the scope of the evidence relating to the treatment duration and contents of the treatment have not been addressed through additional evidence, arguments and/or claim amendments. Therefore the allegations of unexpected results remain insufficient to outweigh the prima facie case of obviousness.
Regarding the declaration submitted December 31, 2025, Applicants argue that there 21 days of product application refers to the duration of the treatment course and not to 21 daily applications. Properly understood there is no inconsistency with the claimed method.
These arguments are unpersuasive. Applicants’ arguments as to the meaning of a phrase in a declaration cannot take the place of evidence. The Examiner was unable to locate any claim language specifying the duration of treatment. There are claim limitations as to the number of consecutive applications, the interval between applications of the different compositions, but not on the total duration of the method carried out as recited in the declaration. The evaluation is based on the evidence of record as that evidence does not outweigh the prima facie case of obviousness and therefore the rejection is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Applicants request that the provisional nonstatutory double patenting rejections be held in abeyance until otherwise-allowable subject matter is identified in the present application.
The provisional nonstatutory double patenting rejections are maintained for the reasons of record set forth in the Office Action mailed April 16, 2026 and those set forth herein.
Claims 1 – 3, 5, 6, 8 and 10 – 14 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 15 of copending Application No. 17/780,749 in view of Reme et al. (Vet Dermat, 2004) in view of Paufique (WO 2017/121965; all citations from US 2019/0060390, the PGPub of the national stage entry as WO’965 was published in French) and Allart et al. (US 2005/0037035). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 16, 2026 and those set forth herein.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 3, 5, 6, 8 and 10 – 14 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 14 of copending Application No. 17/780,764 in view of Reme et al. (Vet Dermat, 2004) in view of Paufique (WO 2017/121965; all citations from US 2019/0060390, the PGPub of the national stage entry as WO’965 was published in French) and Allart et al. (US 2005/0037035). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 16, 2026 and those set forth herein.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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