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 16, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 102 – Anticipation (New Rejection)
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 9 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vierling et al. (US 9636284).
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.
One would only need to add a zinc salt to the exemplified formulation to arrive at 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.
Therefore, Vierling et al. anticipate the instant claims.
Response to Arguments
The Examiner submits that Vierling discloses using zinc in the composition. A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." See MPEP 2131.02, III. One would at once envisage adding other named additives and active agents to the exemplified formulations. Therefore, because zinc is specifically named, one would have once envisaged adding zinc to the exemplified formulations. In regards to the amendment, it would appear that this property is dependent on the combination of betaine and taurate surfactant, which are both present in the example of Vierling. Therefore, it would appear that this property would be an inherent property of the composition Vierling. One would reasonably conclude that the presence of the two surfactants and fluoride, would yield a decrease in dental erosion.
Claim Rejections - 35 USC § 103 – Obviousness (Maintained Rejections)
1) Claims 1-6, 9 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Vierling et al. (US 9636284).
Vierling et al. is discussed above and is believed to anticipate the instant claims. However, purely arguendo and for the purposes of this rejection, Vierling et al. differ from the instant claims insofar as it does not exemplify a composition comprising a zinc ions source in combination with cocoamidopropyl betaine and sodium methyl cocoyl taurate.
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 added zinc citrate to the formulations of Vierling et al. because Vierling et al. disclose they are suitable for incorporation into the compositions as anti-tartar agents.
Response to Arguments
The Examiner submits that Vierling discloses using zinc in the composition. Therefore, it would have been obvious to one of ordinary skill in the art to have added zinc because zinc is specifically suggested as suitable to be used in the composition disclosed therein. In regards to the amendment and alleged unexpected results, it would appear that this property is dependent on the combination of betaine and taurate surfactant, which are both present in the example of Vierling. Therefore, one of ordinary skill in the art would reasonably conclude that the example comprising a combination of cocoamidopropyl betaine and sodium methyl cocoyl taurate along with fluoride would have the property of having a hardness repair of at least about 30%. One would also reasonably conclude that with the addition of the suggested zinc, that the resulting composition would also have this property. Furthermore, it has not been shown the effect on enamel repair without the presence of zinc. Therefore, it cannot be concluded that the enamel repair is dependent on zinc being present and not just the combination of surfactants. Therefore the rejection is maintained.
2) Claims 11-14 and 21 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. is discussed above and 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 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. Vierling discloses using zinc salts in the compositions. Strand provides motivation as to why one of ordinary skill in the art would use zinc citrate and zinc oxide in combination. Further, one would look to Strand because it discloses oral care compositions and therefore is analogous art. Therefore, it would have been obvious to use zinc citrate and zinc oxide in the composition of Vierling and impermissible hindsight was not used.
3) Claims 11-17 and 21 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. is discussed above and 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.
Conclusion
Claims 1-6, 9, 11-17, 21 and 24 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached on 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612