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 22, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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, 3, 5, 9-16, 18, 22-24, 28 and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Harper et al. (WO 9715277) in view of Thomson et al. (US 20170367939).
Harper et al. disclose antiplaque oral compositions such as toothpastes, gel dentifrices and mouthwashes (Abstract). The compositions comprise a source of stabilized stannous ions in an amount effective to provide at least about 300 ppm of soluble stannous ions in the composition; and (c) an orally acceptable vehicle. Stabilized stannous ions sources include stannous fluoride and stannous chloride. In order to be effective against plague and gingivitis the level of soluble stannous ions in the oral composition should be in the range of about 300 ppm to about 13,000 ppm, preferably about 800 ppm to about 10,000 ppm and most preferably about 3000 ppm to about 7500 ppm (page 16, line 25 to page 17, line 2). The pH of the dentifrice composition according to the present invention is from about 3 to about 8 (page 18, lines 27-30). Suitable abrasive substances for use in this invention include hydrated silica, calcium carbonate, calcium pyrophosphate, dicalcium phosphate dihydrate, or alkali metal meta-phosphates (page 22, lines 20-35). The dentifrice composition of this invention may also contain a desensitizing agent such as strontium chloride, potassium nitrate or sodium citrate-citric acid, which may be used in an amount from about 0.5% w/w to about 10% w/w (page 23, lines 15-20). Citrate has also been disclosed to reduce staining (incorporated reference at page 9, Lukacovic et al., US 5213790, col. 1, lines 50-55). Surfactants are used and comprise 0.1 to 3.0% w/w of the composition. The surfactant may be anionic, nonionic or amphoteric. A dentifrice comprises 2.5% sodium gluconate, 0.454% stannous fluoride, 0 or 1.5% stannous chloride, 20% silica, about 20% water, sorbitol, 1.25% sodium lauryl sulfate, and glycerin (page 25, Examples 1 and 2). The composition does not comprise zinc or polyphosphate.
Harper et al. differ from the instant claims insofar as they do not disclose the RDA values.
Thomson et al. disclose oral care compositions. Thomson et al. However, the additional abrasives are preferably not present in a type or amount so as to increase the RDA of the dentifrice to levels which could damage sensitive teeth, e.g., greater than 130. The composition may comprise a surfactant and includes sodium lauryl sulfate and betaines (paragraphs 0105 and 0108). The surfactant or mixtures of compatible surfactants can be present in the compositions of the present invention in 0.1% to 5%, in another embodiment 0.3% to 3% and in another embodiment 0.5% to 2% by weight of the total composition (paragraph 0109).
It would have been obvious to one of ordinary skill in the art prior to the filing of the instant application to have made the compositions of Harper et al. with an RDA lower than 130 in order not to damage the teeth as disclosed by Thomson et al.
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 to have used citric acid/citrate in the compositions of Harper et al. to reduce staining because the incorporated reference, Lukacovic et al. disclosed by Harper et al., specifically discloses citrate ions reduce staining, and because citric acid is suitable for use as desensitizing agent as well as a buffer.
It would have been obvious to one of ordinary skill in the art to have used a combination of sodium lauryl sulfate and a betaine in the composition of Harper et al. because they are suitable surfactants for oral care compositions.
In regards to the ratios, the amounts used in the examples and disclosed in the instant specification are encompassed by the ratios of tin, monodentate and polydentate ligand recited by the instant claims.
In regards to no water added, omission of an element and its function is obvious if the function of the element is not desired. See MPEP 2144.04, II. It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have removed water from the compositions motivated by the desire to inhibit premature reaction of the active agents.
Response to Arguments
The Examiner submits that the citric-citrate of Harper is used for their desensitizing function and may comprise 0.5 to 10% by weight of the compositions. Therefore, this leads to an overlap of the ratio recited by the instant claims. In regards to the examples not disclosing citric acid, "the use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See MPEP 2123. Therefore, although citric acid is not used in an example, non-preferred embodiments may be relied on to meet the limitations of the instant claims. In regards to citric acid’s function as a polydentate ligand for chelating, this would be a property of the citric acid and would occur whether mentioned or not. In regards to Lukacovic not disclosing the function of citric acid, Lukacovic discloses that “[t]he present inventor has discovered that the staining can be reduced by the use of a composition containing citrate ions with the stannous ion formulation” (col.1, lines 50-53). Therefore it would have been obvious to have added citric acid to the composition of Harper because Harper suggests it and a reference incorporated into Harper because Harper discloses the benefits. Therefore impermissible hindsight was not used. In regards to the ratio, that would take more than routine optimization to get the desired effect. The guidance comes from Harper, which discloses citric may be added in an amount of 0.5 to 10%. Using citric acid in an amount of 2.5% would meet the limitation of “about” 1:2.5:2.5. The prompt to add 2.5% or 0.5% citric acid to the composition of Harper is Harper suggesting that it is suitable for use in their disclosed compositions. Therefore the ratios of the 3 combined components overlap that of the instant claims. In regards to combining all the parameters, one would only have to vary one parameter, the citric acid. Therefore there would be a reasonable expectation of success.
Applicant does not appear to support that the ratio of the instant claims provides an unexpected result. Therefore it cannot be determined the effect the ratio has on the tin and/or fluoride uptake. Further, it is not clear if the alleged increase in uptake is due to the ratio of only 2 or the 3 components. Further, it would have been in the relative skill of one of ordinary skill in the art to have adjusted the amount citrate to obtained the desired results. In regards to the RDA value and the examples of the instant specification, the results of Ex. 1-3 look comparable wherein Exs. 2 and 3 being almost the same in regards to stain intensity after 3 weeks and Exs. 1 and 3 being almost the same after 2 weeks. Therefore it does not appear that the results are unexpected or that the instantly recited ratios provide an advantage. Even if the results were in deed unexpected, the claims are not commensurate with regard to the monodentate ligand and the polydentate ligand. It is not clear if the ligand encompassed by the two terms would yield the disclosed results. Therefore, the rejection is maintained.
Conclusion
Claims 1, 3, 5, 9-16, 18, 22-24, 28 and 30-32 are rejected.
Claims 6, 17, 19-21 and 25-27 are withdrawn.
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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