DETAILED ACTION
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/09/2026 has been entered.
Previous Rejections
Applicant’s arguments, filed 11/10/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 65-80, 81-84 and 86-88 are rejected under 35 U.S.C. 103 as being unpatentable over Biffi et al (WO 2020/245784 A1), in view of DE 2020/10008308U1, further in view of CN 108324681A and further in view of Middleton et al (US 2018/0168193 A1).
Biffi taught compositions comprising mixtures of an extract or concentrate of Vaccinium macrocarpon fruits (cranberries), titrated in proanthocyanidins [abstract and claim 1]; and, mixed with zinc and salts thereof (e.g., zinc citrate, at 30 %) [page 12, line 2; page 20, line 6], for treating inflammation (e.g., of the gastrointestinal tract) [page 1, lines 15-16]. Subjects were disclosed, where animals were generally taught [page 18, line 3]. Oral administration was taught [page 15, lines 27 and 29].
Biffi did not teach a gel base, as was elected. Although Biffi generally taught animals, Biffi was silent dogs, as was instantly elected.
DE 2020/10008308U1 taught, at the abstract, compositions comprising mixtures of Vaccinium macrocarpon extract and zinc. The composition was formulated in dosage form as a gel [page 9, 4th paragraph]. Oral administration was taught (e.g., tablet, lozenge, chewable tablets, capsule, etc.; page 9, 4th paragraph].
CN 108324681A teaches, at the abstract, that oral compositions having a gel base, are convenient to use, reduce administration time and have a stronger (increased) administration compliance.
Since Biffi taught oral administration of compositions comprising mixtures of Vaccinium macrocarpon extract and zinc, it would have been prima facie obvious to one of ordinary skill in the art to include a gel base within the teachings of Biffi. The ordinarily skilled artisan would have been motivated to ease convenience of use, to reduce administration time and to increase compliance, as was taught of oral compositions having gel bases, by CN 108324681A.
Although Biffi generally taught administration to animals, Biffi, in view of DE 2020/10008308U1 and CN 108324681A, did not teach administration to dogs, as elected.
Middleton taught compositions compromising proanthocyanidins (and zinc at ¶[0075]), specifically formulated for dogs, for the purposes of maintaining health and modulating health parameters [abstract and claim 1].
Since Biffi generally taught the administration of proanthocyanidins to animals, it would have been prima facie obvious to one of ordinary skill in the art to include dogs within the combined teachings of Biffi, DE 2020/10008308U1 and CN 108324681A, as taught by Middleton. The ordinarily skilled artisan would have been motivated to maintain the health, and to modulate the health parameters, of dogs, with compositions comprising proanthocyanidins and zinc, as was taught by Middleton (abstract, claim 1 and at ¶ [0075]).
The Examiner notes that the intended use (e.g., specifically treating inflammation in an animal) does not result in a structural difference between the claimed invention and the combined teachings of the prior art. For example, there does not appear to be structural differences between the claimed composition, and the composition as taught by the combined teachings of the prior art. As such, the composition as taught by the combined teachings of the prior art meets the claim limitations of the instant claim 65.
Furthermore, it appears that the compositions of the instant claims and those of the combined teachings of the prior art would reasonably be expected to have substantially the same physical and chemical properties (e.g., specifically treating inflammation in an animal). Inherent features need not be recognized at the time of the invention. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. MPEP 2112 II. It should be noted that a chemical composition (e.g., composition comprising A-type proanthocyanidin and zinc) and its properties (e.g., specifically treating inflammation in an animal) are inseparable. If the prior art teaches the identical chemical compounds, then the properties that the Applicant discloses and/or claims are necessarily present (see MPEP 2112).
The combined teachings of Biffi, DE 2020/10008308U1, CN 108324681A and Middleton et al read on claims 65, 68, 71-76, 77-79, 80, 82-84 and 86-88.
Claims 66-67 and 69-70 are rendered prima facie obvious because Biffi taught the extract of Vaccinium macrocarpon fruits at an amount comprised in the range from 0.01% to 5% by weight, the extract, being titrated in proanthocyanidins at a % by weight comprised from 10% to 60% by weight; wherein said %s were expressed with respect to the total weight of the mixture.
The instant claim 66 recites at least 0.001 % PAC-A.
The instant claim 67 recites between 0.001 % and 10 % PAC-A.
The instant claim 69 recites between 0.05 % and 15 % PAC-A, with respect to a total weight of the composition.
The instant claim 70 recites between 1 % and 3 % PAC-A.
Biffi taught the extract of Vaccinium macrocarpon fruits at an amount comprised in the range from 0.01% to 5% by weight, the extract, being titrated in proanthocyanidins at a % by weight comprised from 10% to 60% by weight; wherein said %s were expressed with respect to the total weight of the mixture. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
The instant claim 78 recites at least 0.01 % zinc-containing compound. Biffi taught 30 % of zinc citrate. A prima facie case of obviousness exists because of overlap, as discussed above.
As to claim 79, the claim requires between 0.01 % and 25 % of the zinc-containing compound. As discussed, Biffi taught 30 % of zinc citrate. The ordinarily skilled artisan would have been motivated to have modified this to have been between 0.01 % and 25 %. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of administration of mixtures of zinc with PAC-A to treat inflammation have been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum dosage of compositions for treating inflammation via routine experimentation.
Response to Arguments
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive.
Applicant's Declarations (1. Andree-Ann Adam, 2. Dr. Jean-Philippe Cote), filed 11/10/2025, have been fully considered but they are not persuasive.
Declarants argued that, concerning claim 65, the synergistic effect between PAC-A and zinc is not dependent on the concentrations of either PAC-A or zinc.
The Examiner responds that if there is no criticality of concentrations, then synergism is inherent to the composition of the closest prior art, (Biffi et al, WO 2020/245784), which taught compositions comprising mixtures of cranberries and zinc salts. This is because chemical compounds and their properties are inseparable. In that case, the instant invention is obvious over Biffi et al, as maintained in the Final Office Action.
Regarding evidence of synergy, the data (instant Figure 10 (3C, 3E); Figure 12 (5C, 5F)) shows that synergy exists at 1 % PAC-A and 0.2 % zinc, and as such, the present claim 65 is not commensurate in scope with the showing.
The Examiner notes the Declarant’s arguments in reference to ¶s [066] and [082], but this is merely argument since it is unsupported by fact. Arguments cannot take the place of evidence in the record. In the instant case, ¶s [066] and [082] state the concentrations and formulations that instant compositions may comprise. Those paragraphs do not support allegations that the synergistic effect between PAC-A and zinc is not dependent on the concentrations of either.
The Obviousness rejection is maintained. The Examiner recommends amendment of claim 65, to be commensurate in scope with the showing (see the Examiner’s summary of the 10/08/2025 Applicant-Initiated Interview).
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
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