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 Request for Continued Examination, filed June 11, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Rejections)
1) Claims 1-6, 9, 13-14, 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Vierling et al. (US 9,636,284) in view of Strand (CA 2769314).
Vierling et al. disclose oral care compositions suitable for cleaning the oral cavity (Abstract). The compositions include liquid gel dentifrices and gel or liquid gel mouth rinses. The composition comprise from 0.001% to about 12% of a surfactant or surfactant system, and at least 45% (or about 45%) of a liquid carrier. Surfactants include sodium methyl cocoyl taurate and alkylamidopropyl betaines. Anti-tartar agents include zinc citrate and comprise 0.1 to about 1% of the composition (col. 17, 60-67. Oral care actives include fluoride ion sources such as sodium fluoride and comprise from 1 to 1500 ppm of fluoride ions (col. 17, lines 35-43). An example comprises water, sorbitol, 0.74% cocoamidopropyl betaine, 0.1613 sodium fluoride and 1.33% sodium methyl cocoyl taurate (Formulation 8.6).
The amounts of cocoamidopropyl betaine and sodium methyl cocoyl taurate in Formulation 8.6 result in a ratio falling within the range recited by the instant claims.
Formulation 8.6 only comprises betaine as the amphoteric surfactant.
In regard to the method, the composition are used to clean and treat the teeth and therefore encompass a method of prophylaxis.
Vierling et al. is differ from the instant claims insofar as they do not disclose a combination of zinc salts such as zinc oxide and zinc citrate.
Strand discloses oral care compositions that may be used of delivering potassium salts. The compositions are used to treat tooth sensitivity. The method would meet prophylaxis of instant claim 24. The compositions may comprise surfactants which include amphoteric, nonionic and cationic surfactants. Anionic surfactants include sodium methyl cocoyl taurate (meeting Formula (I), instant claims 3-6), which is typically used in an amount from 0.1% to 2.5% (instant claim 6). Amphoteric surfactants include betaines such as cocoamidopropyl betaine (page 7, lines 11-16). The surfactants may be used in mixtures. Sources of fluoride ions are used in the composition and include sodium fluoride (instant claim 9) in amounts from 0.01 to 0.35% (100 to 3500 ppm) (page 7, lines 19-30). The compositions may comprise amino acids (page 5, lines 2-4). Zinc ions may be included and comprise 0.1 to 1.5% by weight. Zinc compounds include zinc citrate and zinc oxide and may be used in mixtures (page 9, lines 10-19) (instant claims 11-12). Water comprises from 20% to 65% total water (page 10, lines 1-5). A toothpaste comprises 0.213 zinc oxide, 0.533% zinc citrate, 5% potassium nitrate, 0.243% sodium fluoride, 3% cocoamidopropyl betaine and water.
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 combination of zinc citrate and zinc oxide in the composition of Vierling et al. because they are suitable zinc salt to treat tartar.
Zinc salts may be used in combination and may comprise from 0.1 to 1.5% by weight of the composition. Zinc salts are chelating agent and therefore are result effective variables. It would have taken no more than the relative skill of one of ordinary skill in the art to have used a combination of zinc citrate and zinc oxide in the composition of Vierling et al., and adjusted the amounts of zinc oxide and zinc citrate to yield the desired therapeutic effect as a chelating agent. See MPEP 2144.05, IIA.
Response to Arguments
The Examiner submits that in regards to the swishability of Vierling and gellan gum, Vierling suggest using zinc salts in their compositions. Further, gellan gum does not appear to be required by the compositions. Furthermore, the Formulation 8.6 does not comprise gellan gum. Therefore adding zinc to the 8.6 would not affect the swishability of the composition. Further, because Vierling does not disclose gellan as an essential component and does not use it in Formulation 8.6, adding zinc would not teach away from the teachings of Vierling. In regards to an alternative path, Vierling suggest using zinc and the formulation exemplified by Vierling do not comprise and/or require gellan gum. Therefore, the swishable gels of Vierling may comprise zinc with interfering with the swishability.
2) Claims 1-6, 9, 13-14, 16-17, 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Vierling et al. (US 9636284) in view of Das et al. (US 2020/0138686).
Vierling et al. disclose oral care compositions suitable for cleaning the oral cavity (Abstract). The compositions include liquid gel dentifrices and gel or liquid gel mouth rinses. The composition comprise from 0.001% to about 12% of a surfactant or surfactant system, and at least 45% (or about 45%) of a liquid carrier. Surfactants include sodium methyl cocoyl taurate and alkylamidopropyl betaines. Anti-tartar agents include zinc citrate and comprise 0.1 to about 1% of the composition (col. 17, 60-67. Oral care actives include fluoride ion sources such as sodium fluoride and comprise from 1 to 1500 ppm of fluoride ions (col. 17, lines 35-43). An example comprises water, sorbitol, 0.74% cocoamidopropyl betaine, 0.1613 sodium fluoride and 1.33% sodium methyl cocoyl taurate (Formulation 8.6).
The amounts of cocoamidopropyl betaine and sodium methyl cocoyl taurate in Formulation 8.6 result in a ratio falling within the range recited by the instant claims.
Formulation 8.6 only comprises betaine as the amphoteric surfactant.
In regard to the method, the composition are used to clean and treat the teeth and therefore encompass a method of prophylaxis.
Vierling et al. is differ from the instant claims insofar as they do not disclose zinc phosphate or a combination of zinc salt such as zinc oxide and zinc citrate, or disclose and amino acid such as arginine.
Das et al. disclose oral care compositions comprising one or more surfactants. The compositions are used to treat tooth sensitivity. The method would meet prophylaxis. The oral care composition may comprise an amino acid. Surfactants include sodium methyl cocoyl taurate and may comprise less than 1% by weight (paragraphs 0040-0041). Other surfactants include cocoamidopropyl betaine (paragraph 0042). The compositions comprise a fluoride source and include sodium fluoride in an amount ranging from greater than 0 to less than 0.8% by weight (paragraph 0047). The amino acid includes arginine and comprises greater than 0 to 20% (paragraphs 0006 and 0028-0029). The compositions comprise an orally acceptable vehicle that include water. The vehicle may comprise 5 weight % to about 60 weight % (paragraphs 0051-0052). The compositions may comprise zinc. The source of zinc includes zinc citrate, zinc oxide and zinc phosphate. A base toothpaste composition comprises 23% sorbitol (70% solution), 10% purified water, 19.6% arginine bicarbonate solution (40.8% solution), 1.1% sodium monofluorophosphate, 1% zinc oxide and 0.5% zinc citrate (TABLE 1). Surfactants were used and include 1% taurate and 3.4% (30%) cocoamidopropyl betaine (TABLE 2). Some of the compositions do not comprise sodium lauryl sulfate. These together meet the second formulation in instant claim 21.
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 zinc phosphate or a combination of zinc citrate and zinc oxide as the anti-tartar agent of Vierling et al. because they are suitable anti-tartar/chelating agents for oral care.
In regard to claim 13, zinc salts may be used in combination and may comprise from 1% zinc oxide and 0.5% zinc citrate. It would have taken no more than the relative skill of one of ordinary skill in the art through routine optimization to have adjusted the amount of zinc oxide and zinc citrate to yield the instantly claimed amount and the desired therapeutic effect. See MPEP 2144.05, IIA.
Response to Arguments
The Examiner submits that in regards the rejection being based on impermissible hindsight, the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144, IV. Das discloses oral care actives suitable for oral care compositions. Das does not appear to teach away from all anionic surfactants because it specifically discloses that sodium methyl cocoyl taurate may be used in the compositions. In regards to the enamel hardness repair, one of ordinary skill in the art would reasonably conclude that the composition of the combined reference would have at least 30% enamel-hardness repair because the composition would comprise a combination of cocoamidopropyl betaine and sodium methyl cocoyl taurate along with fluoride. Therefore, the rejection is maintained.
Response to Declaration by Venda Maloney
The Examiner submits that as stated above, the composition of Vierling do not require gellan gum. Further, the formulation comprising the combination of surfactants claimed does not include gellan gum. Therefore, the swishability of Formulation 8.6 would not be affected by the addition of a zinc salt.
Conclusion
Claims 1-6, 9, 13-14, 16-17, 21 and 24 are rejected.
No claims allowed.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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