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 January 2, 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims
Claim Rejections - 35 USC § 103 – Obviousness (Maintained Rejection)
Claims 1-16 and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Huber et al. (WO 2022/133234) in view of Adomat et al. (DE 102009029163).
Huber et al. disclose an oral care composition that make amine fluorides in situ. The composition comprises amines and zinc-containing compounds. Zinc is a known essential mineral for human health, and has been reported to help strengthen dental enamel and to promote cell repair (paragraph 0005). The zinc includes zinc lactate and zinc citrate (paragraph 0013). They may be added in an amount ranging from 0.1 wt% to about 2.5 wt% of the composition. The amines are amine bases and may be a primary amine base, a secondary amine base or a tertiary amine base (paragraph 0011). The amine base comprises one or more of N'-octadecyltrimethylendiamine-N,N,N'-tris(2-ethanol), and/or N-octadeca-9-enylamine. Specifically they may include a myristyl, palmityl, linoleyl, oleyl, or stearyl amine or polyamine, or N'- octadecyltrimethylendiamine-N,N,N'-tris(2-ethanol), or N-octadeca-9-enylamine, and combinations thereof. Other actives known in the art include N'-octadecyl- N',N,N-tris(2-hydroxyethyl)-l,3-propanediamine dihydrofluoride (an olaflur). The amines comprise about 0.01 wt% to about 5 wt% of the composition. The composition comprises an acid including hydrochloric acid. Fluorides include sodium fluoride. Fluoride comprises about 0.005 wt% to 2.5 wt%. Amine fluorides are produced in situ when the amine, fluoride and acid are combined. An example comprises 1.38% amine base, 0.79% hydrochloric acid, 0.5% zinc lactate and 0.31% sodium fluoride (Table 1).
Huber et al. differ from the instant claims insofar as they do not disclose a stilbenoid.
Adomat et al. disclose mouth and tooth care compositions comprising 0.001-10 wt.% of at least a compound from a hydroxystilbene or its alkyl ether and/or ester; and 0.001-5 wt.% of at least an antibacterial compound. The compositions are used to prevent and treat caries; and/or combat halitosis, gingivitis, or periodontitis (Abstract). The hydroxystilbene monomers are of the general formula (RESV-Ia) or (RESV-Ib): (E)-hydroxystilbene (RESV-Ia) or (Z) -hydroxystilbenes (RESV-Ib), wherein RESV is resveratrol.
Hydroxystilbene includes resveratrol including (Z)-resveratrol. Resveratrol comprises a component that has antimicrobial properties.
Therefore, it would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added a hydroxystilbene, such as (Z)-resveratrol, to the composition of Huber et al. motivated by the desire to use an antimicrobial that can treat caries, malodor, gingivitis and periodontitis.
Response to Arguments
The Examiner submits than in regards to forming a complex, antioxidant and/or anti-inflammatory activity, these do not appear to be recited in the instant claims. Further the antioxidant or anti-inflammatory property of a polyphenolic ingredient would be a property of the polyphenol whether mentioned or not. Therefore, a composition in which the polyphenol is incorporated, would also exhibit some of its property. In regards to the balance of ingredients, Huber discloses that amine is present in an amount ranging from about 0.01 wt% to about 5 wt% of the composition; fluoride comprises about 0.005 wt% to 2.5 wt%; and zinc comprises from 0.1 wt% to about 2.5 wt% of the composition, which are the ranges disclosed by instant claim 1. When a stilbenoid such as resveratrol is used, the amount ranges from 0.001 to 5%, which overlaps the recited range. Therefore, Huber teaches and suggests the specific quantitative balance of ingredients. In regards to Adomat, Adomat was used to disclose stilbenoids and their properties in oral care. These properties make it obvious to add them to the compositions of Huber. Huber discloses the fluoride amine systems used to treat periodontitis and/or gingivitis. Adomat discloses that stilbenoids are used in a composition to treat periodontitis and gingivitis. Therefore, it would have been obvious to have added the stilbenoids of Adomat to the compositions of Huber to treat gingivitis and/or periodontitis. In regards to the stabilizing amine fluoride-resveratrol complex, there appears to be no mention of this complex in the instant claims. Furthermore, one of ordinary skill in the art would reasonably conclude that adding resveratrol in to a composition comprising an amine fluoride, there would be some type of complexation considering the presence of the amine and the hydroxyl groups of resveratrol. In regards to the quantities, Huber teaches the ranges for the amine, the fluoride and the zinc recited by the instant claim. Adomat discloses overlapping ranges of the stilbenoid. In regards to the anti-inflammation and antioxidant increase of Formulation 2 in comparison with Formulation 1, this would be expected because resveratrol has an anti-inflammatory effect and an antioxidant effect. Therefore one would reasonably expect that the anti-inflammatory effect would increase. In regards to the combination of amounts being critical, there appears to be no examples that show the components outside of the recited range. Therefore, it is not clear the criticality of the claimed amount ranges. In regards to the complex, the claims don’t appear to recite a complex or stability. Therefore, the rejection is maintained.
Conclusion
Claims 1-16 and 19-22 are rejected.
No claims 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 LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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