DETAILED ACTION
Notice of Change in Examiner
The present application, previously examined by examiner AMANDA PETRITSCH, is currently being examined by CELESTE A RONEY. The examiner’s contact information can be found below.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/22/2024 has been entered.
Previous Rejections
Applicant’s arguments, filed 11/22/2024, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Response to Arguments
Applicant’s arguments with respect to the instant claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112 – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5-11 and 13-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites that the compositions contain “no zinc”. The originally filed disclosure does not appear to contain support for the exclusion of zinc. Appropriate correction and/or clarification of the claim scope is required.
Claim Rejections - 35 USC § 112 –
Indefiniteness, Indefinite Language and Broad to Narrow Limitations
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 5, 7-11 and 13-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding indefinite language, the instant claim 10 recites the phrase "preferably", which renders the claim indefinite, because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding broad and narrow limitations, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claims 1, 16 and 17 recite the broad recitation “0.15 wt. % to 20 wt. %”, and the claims also recite “(relative to F-)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In the present instance, claims 2 and 15 recite the broad recitation “caries lesions”, and the claims also recite “(initial caries)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In the present instance, claim 7 recites the broad recitation “more than 1500 ppm”, and the claim also recites “(F-)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In the present instance, claim 10 recites the broad recitations “olaflur and dectaflur”, and the claim also recites “(INN)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The Applicant is encouraged to remove the parentheses from the claims, at each instance of occurrence.
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) 1-2, 5-11 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (US 2017/0368375 A1), in view of Santarpia et al (US 2015/0335551 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].
Although Chen taught water as a carrier in oral care compositions, Chen was silent it’s amount, as recited in claim 1(a). Chen was generally drawn to oral care compositions, though was not specific remineralization, as recited in claim 1.
Santarpia taught oral compositions comprising a basic amino acid (0.01 to about 10 % by weight at claim 10) (e.g., histidine at ¶ [0010-0011]) for treating dental caries [title and abstract]. As per Santarpia, 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% [0050]. 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 lesions of the enamel [0054, 0067].
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 Santarpia. 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% [Santarpia at ¶ 0050].
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 Santarpia. The ordinarily skilled artisan would have been motivated to protect the teeth, as taught by Santarpia [0054, 0067].
The instant claims 1 and 16 recite 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.
Santarpia 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. Santarpia taught amino acids in an amount of 0.01 to about 10 % 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., Santarpia) 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 Santarpia read on claims 1-2, 6, 8, 10-11, 14.
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.
The instant claim 16 recites the transitional language “consists essentially of”. Absent a clear indication in the specification or claims of what the basic and novel characteristics of the claimed composition actually are, the term “consisting essentially of” is construed as being equivalent in meaning to the term “comprising”. PPG v. Guardian, 156 F.3d 1351, 1354 (Fed. Cir. 1998). No such clear indication is seen here.
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].
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 Santarpia et al (US 2015/0335551 A1) and further in view of Gibbs et al (US 2022/0003741A1).
The 35 U.S.C. 103 rejection over Chen and Santarpia was previously discussed.
Additionally, Chen and Santarpia were drawn to mouthwashes (Chen at claim 4; Santarpia at ¶ [0008]).
Although Chen, in view of Santarpia, 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 Santarpia 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 Santarpia, 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.
The instant claim 17 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; 0.01 to 0.5 mol/l amino acid.
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. Santarpia 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. Santarpia taught amino acids in an amount of 0.01 to about 10 % by weight. 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.
The Examiner notes that the amount of amino acids were taught by weight, rather than by molar units, relative to the volume, as is recited. Nevertheless, it would by 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., Santarpia) 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.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612