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 December 31, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 (Maintained Rejections)
1) Claims 1, 3-6, 8-11, 13-16, 19-20, 22 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Strand (CN 102612356).
Strand discloses a single phase oral care composition comprising a stannous salt and a potassium salt. The stannous salt comprises 0.05% to 1.2% (paragraph 0022). Stannous salts include stannous chloride and stannous fluoride (paragraph 0022). Potassium salts comprise 1.9% to 2.5% and include potassium nitrate (paragraph 0024). Surfactants used in the composition include sodium methyl cocoyl taurate in an amount ranging from 0.1 to 2.5% (paragraph 0037). Water is included and comprises 20% to 65% by weight of the composition. Chelating agents may be used and include polyphosphates such as sodium tripolyphosphate. Chelating agents comprise 0.1 to 10% by weight of the composition (paragraph 0028). Humectants are used and comprises 15% to 45% by weight of the composition (paragraph 0066). The compositions may be formulated into toothpaste or gels and include thickening agents (paragraph 0067).
The reference does not appear anticipatory insofar as it does not disclose an exemplary composition comprising all the components of the instant clams. However, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness. Therefore, it would have been obvious to one of ordinary skill in the art to have made a toothpaste comprising a taurate surfactant in combination with a stannous fluoride or stannous chloride; potassium nitrate; and a polyphosphate because it is strongly suggested by Strand and to obtain each components’ known function.
In regards to the composition being a dual phase composition, it would have been obvious to have separated actives into two parts to insure the composition and components remained stable in the presence of water or other carrier.
In regards to the amounts and ratios recited by the instant claims, Strand discloses stannous salts comprise 0.05% to 1.2%; potassium salts comprise 1.9% to 2.5%; chelating agents (polyphosphates) comprise 0.1 to 10%; water comprises 20% to 65% and sodium methyl cocoyl taurate comprises from 0.1 to 2.5% of the composition. The ranges overlap the ranges of each component recited by the instant claims. It is well-settled, however, that even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05. Accordingly, since an overlap plainly exists here, it would have been obvious to have selected values within the overlap.
Further, as stated above, the amounts of each component overlaps that of the instant claims. Therefore, the ratios recited by the instant claims would also overlap that of Strand. Accordingly, the ratios recited by the instant claims are obvious over Strand.
Response to Arguments
The Examiner submits Strand discloses chelating agents may be added and include tripolyphosphate. Strand discloses long chain linear polyphosphate hydrolyze in aqueous compositions. This would not include the tripolyphosphate that strand suggests using. Therefore, Strand does not teach away from tripolyphosphate. In regards to selecting a taurate, Strand specifically discloses sodium methyl cocoyl taurate and that it comprises 0.1 to 2.5 weight % of the composition. Since sodium methyl cocoyl taurate is specifically disclosed, it is strongly suggested by Strand. Therefore, one of ordinary skill in the art would be motivated to use sodium methyl cocoyl taurate because it is specifically named as being a suitable surfactant. In regards to the stability discussed in the instant specification, there appears to be no evidence provided that supports this assertion that a combination of taurate surfactant and an alkali metal polyphosphate results in the stability of stannous, fluoride and nitrate. Therefore the rejection is maintained.
2) Claims 7, 16 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Strand (CN 102612356) in view of Deng et al. (US 20130171221).
Strand differs from the instant claims insofar as it does not disclose hyaluronic acid or tetrasodium pyrophosphate.
Deng et al. disclose oral care compositions. The composition may be formulated into toothpaste. The compositions comprise chelating agents including sodium tripolyphosphate and tetrasodium pyrophosphate (paragraph 0038). The compositions comprises hydrogels to formulate gels. Hyaluronic acid is used to form hydrogels (paragraph 0080). The compositions may be formulated into single or dual phase compositions. A dual phase oral care composition is recommended to prevent inter action between two components (paragraph 0071).
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used hyaluronic acid to make the gel compositions of Strand because they are suitable for use in a gel oral care composition. See MPEP 2144.07.
In order to rely on equivalence as a rationale supporting an obviousness rejection, the equivalency must be recognized in the prior art, and cannot be based on applicant’s disclosure or the mere fact that the components at issue are functional or mechanical equivalents. It is obvious to replace one component for another equivalent component if it is recognized in the art that two components are equivalent and is not based on the Applicant disclosure. See MPEP 2144.06, II. It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used tetrasodium pyrophosphate in place of sodium tripolyphosphate based on the Deng et al.’s recognition that such species are equivalent in function.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have made a dual phase composition to prevent interaction between components that could interact.
Response to Arguments
The Examiner submits that Strand discloses taurate anionic surfactants may be used in the compositions disclosed therein. Deng cures the deficiencies of the instant claims by disclosing hyaluronic acid is suitable for use in oral care compositions as a gelling agent. It is also discloses tetrasodium pyrophosphate is equivalent to sodium tripolyphosphate. Therefore, it would have been obvious to one of ordinary skill in the art to have added hyaluronic acid to the composition of Strand to obtain its known function and its suitability as a gelling agent and to have substituted sodium tripolyphosphate with tetrasodium pyrophosphate because they are equivalents. In regards to Deng teaching about aqueous compositions and phosphates, Strand discloses long chain linear polyphosphates are hydrolyzed but does not appear to teach this in regards to shorter chain polyphosphates such as tripolyphosphate. Therefore Strand does not teach away from using shorter chain polyphosphates and the rejection is maintained.
Obvious-Type Double Patenting (Maintained Rejections)
1) Claims 1, 3-11, 13-16, 19-20, 22 and 24-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 9-15 and 18-24 of copending Application No. 18/513,925 (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 both sets of claims recite an oral care composition comprising a stannous salt, potassium salt, a phosphate salt and a taurate surfactant. The copending claims differ from the instant claims insofar as they do not recited the specific stannous, nitrate and phosphate salts, making them genus claims to the copending claims. 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.
2) Claims 1, 3-11, 13-16, 19-20, 22 and 24-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 40-60 of copending Application No. 18/516,422 (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 both sets of claims recite an oral care composition comprising a stannous salt, potassium salt, a phosphate salt and a combination of surfactants including a taurate surfactant. The instant claims differ from the copending claims insofar as they do not recite a second surfactant. The claims recite comprising and do not exclude other surfactants. 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, 3-11, 13-16, 19-20, 22 and 24-26 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.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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