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 October 20, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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 (New Rejections)
Claims 1-3, 9, 11, 15-20 and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vemishetti et al. (EP 3283046) in view of Nakayama et al. (JP 2009155240).
Vemishetti et al. disclose oral care composition comprising a zinc ion source, a stannous ion source, polyphosphates and acid in a calcium pyrophosphate base. Calcium pyrophosphate comprises 1% to 50% by weight of the composition. The composition may comprise beta calcium pyrophosphate in an amount ranging from 2 to 5% as a secondary agent (paragraph 0074). Stannous ion sources include stannous fluoride, stannous chloride and stannous sulfate (paragraph 0001). Acids include maleic and tartaric acid. Amino acids may also be used and include aspartic acid and glutamic acid. Polyphosphates used include sodium tripolyphosphate, tetrasodium pyrophosphate and tetrapotassium pyrophosphate (paragraph 0031). Zinc sources include zinc citrate, zinc lactate and zinc oxide (paragraph 0032). A toothpaste comprises calcium pyrophosphate, 0.454% stannous fluoride, 1% zinc oxide, tetrasodium pyrophosphate, sodium tripolyphosphate, glycerol, sodium saccharin, sodium lauryl sulfate and flavor (Table 1).
The composition do not required zinc oxide, zinc citrate, zinc phosphate or titanium dioxide.
Vemishetti et al. differ from the instant claims insofar as they do not disclose ethylene glycol distearate.
Nakayama et al. disclose a dentifrice composition excellent in pear effect and effervescence and good in storage stability. The dentifrice composition comprises (A) a fatty acid glycol ester as a pearlescent agent and (B) a betaine-type amphoteric surfactant, wherein the content of component A is 1.5-5.0 mass%, and the mass ratio (A)/(B) is 3.0-6.0 (Abstract). Ethylene glycol distearate (EGDS) is a fatty acid ester of glycols that is easily available as a commonly used pearly luster imparting agent. The EGDS comprises 1.5 to 5% by wt of the composition. Abrasives include calcium pyrophosphate. Fluoride may be added and includes stannous fluoride.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added ethylene glycol distearate to the composition of Vemishetti et al. motivated by the desire to ad a pearl effect to the oral care composition.
In regards to claim 4, the compositions, the toothpaste composition comprise calcium pyrophosphate and an active in an amount encompassed by the instant claims. Therefore the toothpaste composition would have substantially the same whiteness value and amount of tin when the ethylene glycol distearate is added as that recited by the instant claims.
In regards to claim 14, the compositions, the toothpaste composition comprise stannous fluoride in an amount encompassed by the instant claims. Therefore, it is reasonable to conclude that the toothpaste composition would have substantially the same and amount of tin after 30 days as recited by the instant claims.
2) Claims 1-3, 5-9, 11, 15-20 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Vemishetti et al. (EP 3283046) in view of Nakayama et al. (JP 2009155240) in further view of Suleyman et al. (TR 201308235).
Vemishetti et al. in view of Nakayama et al. is discussed above and differs from the instant claims insofar as it does not disclose boron nitride.
Suleyman et al. disclose a composition to prevent tooth decay, gingivitis, periodontitis and tooth sensitivity by preventing demineralization on the tooth surface. The composition comprises a mixture of nano-sized hexagonal boron nitride and fluoride ion and may be in the form of a tooth powder, toothpaste, dental floss, dental gel and mouth rinsing liquid (Abstract). Nano-sized hexagonal boron nitride is inert, does not dissolve or wet by any chemical, and has superior solid lubrication and anti-infection properties in tissues. Hexagonal boron nitride is used in various cosmetic products. Fluoride ion, on the other hand, has been proven to be effective in eliminating tooth decay and accelerating remineralization. Fluorides include sodium fluoride and stannous fluoride. The D50 of the boron is 1000 (1 micron). The boron and fluoride are mixed where 99% to 1% boron is added to 1% to 99% fluoride. One percent of the combination is added to a final oral care composition. When 1-99% boron is used, this would yield about 0.01 to 0.99% when in a toothpaste composition.
It would have been obvious to one of ordinary skill in the art prior to filing the application to have added boron nitride to the composition of Vemishetti et al. in view of Nakayama et al. because boron nitride has superior solid lubrication and anti-infection to help prevent tooth decay, gingivitis and periodontitis.
3) Claims 1-3, 9, 11-12, 15-20 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Vemishetti et al. (EP 3283046) in view of Nakayama et al. (JP 2009155240) in further view of Baig et al. (US 20210093551).
Vemishetti et al. in view of Nakayama et al. is discussed above and differs from the instant claims insofar as it does not disclose hops acid or glycine.
Baig et al. disclose oral care compositions comprising hops and methods of treatment, reduction, and/or prevention of caries using an oral care composition comprising hops (Abstract). Hops are used in the treatment of cavities (paragraph 0010). Suitable hops include hops beta acids. Amino acids are organic compounds that contain an amine functional group, a carboxyl functional group, and a side chain specific to each amino acid. Suitable amino acids include, arginine and glycine. (paragraph 0073).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. It would have been obvious to one of ordinary skill in the art prior to filing the application to have added hops acid and glycine to the composition of Vemishetti et al. in view of Nakayama et al. because hops acids have anticavity properties and glycine as an amino acid.
Obvious-Type Double Patenting (Maintained Rejection)
Claims 1-3, 5-9, 11-12 and 15-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/317,971 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as they are both toothpaste compositions with an oral carrier. The instant claims differ from the copending claims insofar as the dependent claim recites boron nitride, and the independent claim recites calcium pyrophosphate in the independent claim, whereas the copending claims recite calcium pyrophosphate in the dependent claims, and boron nitride in the independent claim. Therefore the instant claims are obvious over the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants respectfully defer these issues until the application is otherwise in condition for allowance. Since this has not occurred, the rejection is maintained.
Conclusion
Claims 1-3, 5-9, 11-12 and 15-24 are rejected.
No claims allowed.
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.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612