DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed 09/17/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 103 - Obviousness
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2, 5-11, 13-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (US 2017/0368375 A1), in view of Kohli et al (US 2010/0316580 A1).
Chen generally taught oral care compositions [title], comprising water as a carrier [0079]; fluoride ion sources (e.g., sodium fluoride, ammonium fluoride) in an amount from 0.001 weight % to 10 weight % [0101]; and dissolved amino acids [0081] (e.g., histidine at claim 3) in an amount of 0.001 weight % to 0.08 weight % by total weight of the composition [0103]. Salts of orthophosphoric acid and abrasives were not disclosed. Polymeric components and zinc were not required. To achieve clinical benefits, Chen’s compositions were applied and brought into contact with the oral cavity for a period of 30 seconds to 5 minutes [0111]. Additionally, Chen was drawn to mouthwashes [claim 4].
Although Chen taught water as a carrier in oral care compositions, Chen was silent it’s amount, as recited in claim 16(a). Chen was generally drawn to oral care compositions, though was not specific remineralization, as recited in claim 16.
Kohli taught oral compositions comprising a basic amino acid (0.1 to about 20 % by weight at ¶ [0012, embodiment 1.0.13.) (e.g., histidine at ¶ [0012, embodiment 1.0.1.) for treating dental caries [claim 24a]. As per Kohli, water is commonly employed in the preparation of commercial oral compositions, making up the balance of said compositions when included in amounts of about 10% to about 90% [0173]. The compositions were useful in protecting the teeth by facilitating repair and remineralization, in particular to reduce or inhibit formation of dental caries, reduce or inhibit demineralization and promote remineralization of the teeth, reduce hypersensitivity of the teeth, and reduce, repair or inhibit pre-carious (e.g., early) lesions of the enamel [0182].
Since Chen generally taught water as a carrier for oral compositions, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Chen, water in amounts of about 10 % to about 90 %, as taught by Kohli. The ordinarily skilled artisan would have been so motivated, because water is commonly employed in the preparation of commercial oral compositions, making up the balance of said compositions when included in amounts of about 10% to about 90% [Kohli at ¶ 0182].
Since Chen generally taught oral care compositions, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Chen, remineralization, as taught by Kohli. The ordinarily skilled artisan would have been motivated to protect the teeth, as taught by Kohli [0182].
The instant claim 16a recites 50 to 99.5 wt. % liquid carrier; 0.15 to 20 % fluoride containing component; 0.01 to 0.5 mol/l dissolved amino acid; reaction time upon the teeth for a period of less than 5 minutes.
The instant claim 9 recites 0.01 to 0.5 mol/l amino acid.
Kohli taught water in amounts of about 10 % to about 90 weight %; Chen taught fluoride ion sources in an amount from 0.001 weight % to 10 weight %, dissolved amino acids in an amount of 0.001 weight % to 0.08 weight % and a period of 30 seconds to 5 minutes within the oral cavity. Kohli taught amino acids in an amount of 0.1 to about 20 % by weight. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
The Examiner notes that the amount of amino acids were taught by weight, rather than by molar units, relative to the volume, as is instantly recited. Nevertheless, it would be prima facie obvious to one of ordinary skill in the art to empirically determine the molar amount, relative to the volume, of the amino acids. This is because the combined teachings of the art (e.g., Kohli) provide the amount of water. As such, the skilled artisan can empirically calculate the molar amount of amino acids from the information (e.g., amino acid, weight percent, volume of liquid) therein provided by the teachings of the art.
The combined teachings of Chen and Kohli read on claims 2, 6, 8, 10-11, 14.
Further regarding claims 5 and 16 are rendered prima facie obvious because Chen taught a pH of 2-10 [0094]; sweeteners [claim 5].
The instant claims 5 and 16 recite a pH of 4 to 7 (claim 5); 3 to 8 (claim 16). Chen taught a pH of 2-10. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 7 is rendered prima facie obvious because Chen taught the fluoride ion providing a supply of the ion source at about 50 to about 5000 ppm fluoride [0101].
The instant claim 7 recites the fluoride ion at more than 1500 ppm. Chen taught the fluoride ion at about 50 to about 5000 ppm fluoride. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 13 is rendered prima facie obvious because Chen taught pH modifying agents [0009].
Response to Arguments
Applicant's arguments filed 09/17/2025 have been fully considered but they are not persuasive.
Applicant argued that Chen can contain numerous other components (phosphates, binders, polymeric thickening agents, adhesion agents), which are expressly excluded by the amended claims.
The Examiner disagrees. Chen does not teach numerous other components as required. Chen is not excluded from the claimed invention.
Applicant argued that Chen does not teach the amount of water.
The Examiner responds that Chen was not relied upon for the amount of water, as that was a feature taught by the combination of the references. And one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See MPEP 2145(IV). In the instant case, Kohli was relied upon to teach the amount of water.
Applicant argued that none of the specific compositions described in Table 1 of Chen falls within the scope of the amended claims.
The Examiner responds that Chen is not limited to preferred examples. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. Chen was relied upon as a disclosure as a whole, and is relevant as prior art for all that it contains. See MPEP 2123 I and II.
In response to the Applicant's argument that Chen is concerned with compositions intended for a completely different purpose than the claimed compositions, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See MPEP 2145 IX.
In this case, Chen is drawn to oral care compositions [title], specifically, oral care compositions comprising a basic amino acid or a salt thereof, and an orally acceptable carrier. The compositions were effective in enhancing repair of damaged tissue of the oral cavity [abstract]. The instant invention is drawn to compositions for teeth [title], specifically, for the therapeutic treatment of teeth, which contain at least one fluoride-containing component, at least one amino acid and a liquid carrier. The Examiner disagrees that Chen is drawn to a different purpose than the instant invention.
Furthermore, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See MPEP 2145 II. In the instant case, Chen, in view of Kohli, read on the claimed invention. The 35 USC § 103 rejection over Chen is maintained. The rejection, in view of Kohli is newly applied.
Claim(s) 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (US 2017/0368375 A1), in view of Kohli et al (US 2010/0316580 A1) and further in view of Gibbs et al (US 2022/0003741A1).
The 35 U.S.C. 103 rejection over Chen and Kohli was previously discussed.
Additionally, Chen and Kohli were drawn to mouthwashes (Chen at claim 4; Santarpia at ¶ [0134, 0152]).
Although Chen, in view of Kohli, taught application to the teeth, as was previously described, the combined teachings of the art were silent an amount of 0.1 to 0.5 mL, as recited in claims 15 and 17.
Gibbs taught an oral wash, wherein the volume of the oral wash composition used for rinsing the oral cavity was 0.5 mL. The oral wash was left in the oral cavity for 20 seconds to 4 minutes [0046].
Since the combined Chen and Kohli generally taught mouthwashes, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Chen and Kohli, the mouthwash at 0.5 mL. The ordinarily skilled artisan would have been motivated to rinse the oral cavity, as taught by Gibbs [0046]. The ordinarily skilled artisan would have left the wash in the mouth for 20 seconds to 4 minutes, because the said amount of time is sufficient to rinse the oral cavity, as taught by Gibbs at ¶ [0046].
The instant claims 15 and 17 recite 0.1 to 0.5 mL volume; a reaction time on the tooth/teeth of less than 5 minutes.
Chen taught a period of 30 seconds to 5 minutes on the teeth, as previously discussed. Gibbs taught 20 seconds to 4 minutes in the mouth; and, a volume of 0.5 mL. Chen taught a period of 30 seconds to 5 minutes within the oral cavity. Gibbs taught a volume of 0.5 mL and a reaction time on the teeth of 20 seconds to 4 minutes. A prima facie case of obviousness exists because of overlap, as discussed above.
Response to Arguments
Applicant's arguments filed 09/17/2025 have been fully considered but they are not persuasive.
Applicant argued that the ordinarily skilled artisan would not have combined the teachings of Chen with those of Gibbs.
The Examiner disagrees, as both Chen [claim 4] and Gibbs [0046] were drawn to oral washes. The skilled artisan would have included, within Chen, Gibbs, motivated by the desire to rinse the oral cavity, as taught by Gibbs [0046].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/CELESTE A RONEY/ Primary Examiner, Art Unit 1612
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