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 it the Request for Continued Examination, June 1, 2026, 2023, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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)
1) Claims 1-3, 6, 8-15, 18-22, 25 and 27-34 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Yueh et al. (CN 1592605) in view of Pink et al. (WO 93/16680).
Yueh et al. disclose oral care compositions having low water content. The compositions may comprise less than 10% water. The compositions are formulated into dentifrices which includes a toothpaste, paste or gel. Therefore the compositions are not required to be liquids. The compositions comprise a polyphosphate source wherein the average chain is greater than about 4. These include chains having a length of 6, 13 and 21. Wetting agents are used to prevent the toothpaste from drying. These include polyethylene glycol in an amount ranging from 0.1% to 70% (page 2, paragraph 1). An ion active is added and is chosen from fluoride ions, stannous ions, zinc ions and mixtures thereof. Fluoride ions include sodium fluoride, stannous fluoride and sodium monofluoro-phosphoric acid. Stannous metal ions include stannous fluoride and stannous chloride. Zinc ions include zinc oxide, zinc sulfate, zinc chloride, zinc citrate and zinc lactate (page 7). Dental abrasives include precipitated silica or silica gel and comprises about 6% to 70% of the composition. The silica has a grain diameter of preferably 5 microns to about 15 microns. Abrasives also include calcium abrasives. These include calcium carbonate, tricalcium phosphate and calcium pyrophosphate. Peroxide sources may be added to the compositions and include hydrogen peroxide and carbamide peroxide, meeting whitening agents. Zinc is optional. When stannous is present, polyvinyl pyrrolidone may be added to hydrate the composition. This comprises about 1% to about 5% of the composition (page 11, paragraph 2). The compositions include thickening agents selected from the group consisting of polysaccharides, carbomers, poloxamers, modified celluloses, and mixtures thereof (Abstract). An example comprises stannous fluoride, stannous chloride, 20% sodium polyphosphate (Glass H), carrageenan, polyethylene glycol, 12.5% Zeodent 119 (silica), 12.5% Zeodent 109 (silica) and 1.5% Plasdone S-639 (polyvinyl pyrrolidone). No water or zinc is added (Example 16).
Yueh et al. differ from the instant claims insofar as they do not disclose specifically that the PVP is a homopolymer although they do disclose a polymer comprising PVP.
Pink discloses that polyvinyl pyrrolidone is used as a bacterial anti-adherence agent.
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 instant application to have used a homopolymer of PVP as the PVP or have added it to the PVP copolymer of Yue et al. motivated by the desire to obtain its bacterial anti-adherence properties. The combination would meet the limitations of claims 6 and 25.
Further, it would have been obvious to one of ordinary skill in the prior to filing the instant application to have added a whitening agent, an additional abrasive and/or a surface active polymer to obtain their therapeutic property and because the addition of the components are suggested by Yueh et al.
In regards to ratio of surface active polymer to silica surface area of from about 0.01 to about 2.0 mg/m2 and 0.05 to about 0.8 mg/m2; and a viscosity increase of at least about 300% based on the Creep Test, the composition of Yueh et al. in view of Pink et al. comprises PVP in an amount of 1.5% and silica from 25%, which is encompassed by the amounts recited by the instant claims. Therefore the toothpaste composition of Yue et al. in view of Pink et al. would have substantially the same ratio of surface active polymer to silica surface and the viscosity increase as the composition of the instant claims.
2) Claims 1-3, 6, 8-15, 18-22, 25 and 27-34 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over 杉山 眞次 (JP 4803889, JP889) in view of Yueh et al. (CN 1592605).
JP889 discloses a non-aqueous toothpaste comprising polyvinyl pyrrolidone. The polyvinylpyrrolidone has a number average molecular weight of 10,000 to 360,000 and comprises 1 to 10% by mass of the composition. Silica comprises 0.5 to 30% by weight of the composition. An example comprises 1% PVP, 5% silica, 0.2 sodium fluoride and no added water (Example 8). The compositions do not require zinc.
JP889 differs from the instant claims insofar as it does not disclose the particle size of silica.
Yueh et al. disclose oral care compositions having low water content. The compositions comprise a polyphosphate source wherein the average chain is greater than about 4. These include chains having a length of 6, 13 and 21. An ion active is added and is chosen from fluoride ions, stannous ions, zinc ions and mixtures thereof. Fluoride ions include sodium fluoride, stannous fluoride and sodium monofluoro-phosphoric acid. Stannous metal ions include stannous fluoride and stannous chloride. Zinc ions include zinc oxide, zinc sulfate, zinc chloride, zinc citrate and zinc lactate (page 7). Dental abrasives include precipitated silica or silica gel and comprises about 6% to 70% of the composition. The silica has a grain diameter of preferably 5 microns to about 15 microns. Abrasives also include calcium abrasives. These include calcium carbonate, tricalcium phosphate and calcium pyrophosphate. Peroxide sources may be added to the compositions and include hydrogen peroxide and carbamide peroxide, meeting whitening agents. Zinc is optional. When stannous is present, polyvinyl pyrrolidone may be added to hydrate the composition.
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 instant application to have used the silica of Yueh et al. having a specific particle size in the composition of JP889 because they are suitable silica for oral care compositions.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added a pyrophosphate, an additional polymer comprising vinylpyrrolidone such as Plasdone and/or a poloxamer, hydrogen peroxide, a stannous fluoride and a zinc citrate motivated by the desire to obtain their known therapeutic effect as an anticalculus agent, a thickener, a whitening agent, an anticaries agent and an antimicrobial, respectively.
In regards to ratio of surface active polymer to silica surface area of from about 0.01 to about 2.0 mg/m2 and 0.05 to about 0.8 mg/m2; and a viscosity increase of at least about 300% based on the Creep Test, the composition of JP889 in view of Yueh et al. comprises PVP in an amount of 1.5% and silica from 25%, which is encompassed by the amounts recited by the instant claims. Therefore the toothpaste composition of Yue et al. in view of Pink et al. would have substantially the same ratio of surface active polymer to silica surface and the viscosity increase as the composition of the instant claims.
Conclusion
Claims 1-3, 6, 8-15, 18-22, 25 and 27-34 and 38 are rejected.
No claims allowed.
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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612
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