DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/29/2026 has been entered.
Applicants' arguments, filed on 06/29/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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 .
Priority
The instant application claims domestic priority to PRO 63/193,961 filed on 05/27/2021.
Claim Rejections - 35 USC § 112
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 6-7, 9-12, and 33-40 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 instant claim 34, the amended claim recites “wherein the oral care composition is free of copolymers of maleic anhydride and free of copolymers of acid” it is presently clear if the “acid” is meant to be maleic acid or another specific acid or any acid. Because the metes and bounds of the claim are unclear the claim is presently indefinite. The claims 6-7, 9-12, 33, and 35-40 depend from claim 34 and are therefore also indefinite. The Examiner is presently interpreting “free of copolymers of acid” as “free of copolymers of maleic acid”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
A) Claims 6-7, 10-12, and 33-40 are rejected under 35 U.S.C. 103 as being unpatentable over Ansari et al (US Patent Application Publication 20190262254A1).
Ansari teaches that the composition may be a dentifrice (Ansari at [0021]). Ansari teaches that in such a preparation the orally acceptable carrier typically has an aqueous phase comprising water or a water and alcohol mixture. Further, in various embodiments, the oral carrier includes a humectant and surfactant. Generally, if alcohol is present, the weight ratio of water to alcohol is in the range of 1:1 to 20:1, preferably 3:1 to 10:1 and more preferably 4:1 to 6:1. The total amount of water-alcohol mixture in this type of preparation is typically in an amount of 70 to 99.9% of the preparation (Ansari at [0022]). Ansari teaches the use of one or more antisensitivity agents, e.g., potassium salts such as potassium nitrate, potassium bicarbonate, potassium chloride, potassium citrate, and potassium oxalate; capsaicin; eugenol; strontium salts; and combinations thereof. Such agents may be added in effective amounts, e.g., from about 1 wt. % to about 20 wt. % by weight based on the total weight of the composition, depending on the agent chosen (Ansari at [0062]). Ansari teaches that arginine, where present, may be present at levels from, e.g., about 0.1 to about 20 weight % (expressed as weight of free base) (Ansari at [0057]). Ansari teaches the use of sodium phosphate dibasic, potassium phosphate dibasic, dicalcium phosphate dihydrate, calcium pyrophosphate, tetrasodium pyrophosphate, tetrapotassium pyrophosphate, sodium tripolyphosphate, and mixtures of any of two or more of these. In a particular embodiment, for example the compositions comprise a mixture of tetrasodium pyrophosphate (Na4P2O7), calcium pyrophosphate (Ca2P2O7), and sodium phosphate dibasic (Na2HPO4), e.g., in amounts of ca. 3-4% of the sodium phosphate dibasic and ca. 0.2-1% of each of the pyrophosphates. In another embodiment, the compositions comprise a mixture of tetrasodium pyrophosphate (TSPP) and sodium tripolyphosphate (STPP) (Na5P3O10), e.g., in proportions of TSPP at about 1-2% and STPP at about 7% to about 10%. Such phosphates are provided in an amount effective to reduce erosion of the enamel, to aid in cleaning the teeth, and/or to reduce tartar buildup on the teeth, for example in an amount of 2-20%, e.g., ca. 5-15%, by weight of the composition (Ansari at [0061]). Ansari teaches the use of stannous fluoride in an amount of about 0.01 weight % to about 1 weight % (Ansari at [0059]). Ansari teaches Representative fluoride ion sources include, but are not limited to, stannous fluoride, sodium fluoride, potassium fluoride, potassium monofluorophosphate, sodium monofluorophosphate, ammonium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluoride (such as, but not limited to, olaflur (N′-octadecyltrimethylendiamine-N,N,N′-tris(2-ethanol)-dihydrofluoride), ammonium fluoride, and combinations thereof. In certain embodiments the fluoride ion source includes stannous fluoride, sodium fluoride, sodium monofluorophosphate as well as mixtures thereof. In certain embodiments, the oral care composition of the invention may also contain a source of fluoride ions or fluorine-providing ingredient in amounts sufficient to supply about 25 ppm to about 25,000 ppm of fluoride ions, generally at least about 100 ppm, e.g., about 500 to about 2000 ppm, e.g., about 1000 to about 1600 ppm, e.g., about 1450 ppm. The appropriate level of fluoride will depend on the particular application. A toothpaste for general consumer use would typically have about 1000 to about 1500 ppm, with pediatric toothpaste having somewhat less. A dentifrice or coating for professional application could have as much as about 5,000 or even about 25,000 ppm fluoride. Fluoride ion sources may be added to the compositions of the invention at a level of about 0.01 weight % to about 10 weight % in one embodiment or about 0.03 weight % to about 5 weight %, and in another embodiment about 0.1 weight % to about 1 weight % by weight of the composition in another embodiment (Ansari at [0059]).Ansari teaches the composition may also include additional polymers to adjust the viscosity of the formulation or enhance the solubility of other ingredients. Such additional polymers include polyethylene glycols, polyvinyl methyl ether maleic acid copolymers, polysaccharides (e.g., cellulose derivatives, for example carboxymethyl cellulose, or polysaccharide gums, for example xanthan gum or carrageenan gum) (Ansari at [0063]).Ansari teaches the use of silica thickeners, which form polymeric structures or gels in aqueous media, may be present. Note that these silica thickeners are physically and functionally distinct from the particulate silica abrasives also present in the compositions, as the silica thickeners are very finely divided and provide little or no abrasive action. Other thickening agents are carboxyvinyl polymers, carrageenan, hydroxyethyl cellulose and water soluble salts of cellulose ethers such as sodium carboxymethyl cellulose and sodium carboxymethyl hydroxyethyl cellulose. Natural gums such as karaya, gum arabic, and gum tragacanth can also be incorporated. Colloidal magnesium aluminum silicate can also be used as component of the thickening composition to further improve the composition's texture. In certain embodiments, thickening agents in an amount of about 0.5% to about 5.0% by weight of the total composition are used (Ansari at [0068]). Ansari teaches that in preparing oral care compositions, it is sometimes necessary to add some thickening material to provide a desirable consistency or to stabilize or enhance the performance of the formulation. In certain embodiments, the thickening agents are carboxyvinyl polymers, carrageenan, xanthan gum, hydroxyethyl cellulose and water soluble salts of cellulose ethers such as sodium carboxymethyl cellulose and sodium carboxymethyl hydroxyethyl cellulose. Natural gums such as karaya, gum arabic, and gum tragacanth can also be incorporated. Silica may also be available as a thickening agent, e.g., synthetic amorphous silica. Colloidal magnesium aluminum silicate or finely divided silica can be used as component of the thickening composition to further improve the composition's texture. In certain embodiments, thickening agents in an amount of about 0.5% to about 5.0% by weight of the total composition are used. Thickeners may be present in an amount of from 1 weight % to 15 weight %, from 3 weight % to 10 weight %, 4 weight % to 9 weight %, from 5 weight % to 8 weight %, for example 5 weight %, 6 weight %, 7 weight %, or 8 weight % (Ansari at [0085]). Ansari teaches that within certain embodiments of the oral compositions, it is also desirable to incorporate a humectant to reduce evaporation and also contribute towards preservation by lowering water activity. Certain humectants can also impart desirable sweetness or flavor to the compositions. The humectant may be present in the composition in an amount of from 10 weight % to 40 weight % in one embodiment, or from 15 weight % to 30 weight % in another embodiment, by total weight of the composition. Suitable humectants include edible polyhydric alcohols such as glycerine, sorbitol, xylitol, propylene glycol as well as other polyols and mixtures of these. Typically, the composition of the present invention comprises a combination of glycerine and sorbitol (Ansari at [0071]). Ansari does not require copolymers of maleic anhydride or copolymers of maleic acid.
Ansari differs from the instant claims in this rejection insofar as it does not teach the combination of the instantly recited components with sufficient specificity for anticipation. Ansari teaches the components of the instant recited composition and uses each component of their established function in the art but does not explicitly combine the components together into a single embodiment or a preferred composition. However, given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Ansari to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
Regarding instant claim 34, Ansari teaches that the composition may be a dentifrice (Ansari at [0021]).
Ansari teaches the use of one or more antisensitivity agents, e.g., potassium salts such as potassium nitrate, potassium bicarbonate, potassium chloride, potassium citrate, and potassium oxalate; capsaicin; eugenol; strontium salts; and combinations thereof (Ansari at [0062]).
Ansari teaches that arginine, where present, may be present at levels from, e.g., about 0.1 to about 20 weight % (expressed as weight of free base) (Ansari at [0057]).
Ansari teaches the use of sodium phosphate dibasic, potassium phosphate dibasic, dicalcium phosphate dihydrate, calcium pyrophosphate, tetrasodium pyrophosphate, tetrapotassium pyrophosphate, sodium tripolyphosphate, and mixtures of any of two or more of these. In a particular embodiment, for example the compositions comprise a mixture of tetrasodium pyrophosphate (Na4P2O7), calcium pyrophosphate (Ca2P2O7), and sodium phosphate dibasic (Na2HPO4) (Ansari at [0061]).
Ansari teaches that in such a preparation the orally acceptable carrier typically has an aqueous phase comprising water or a water and alcohol mixture. Further, in various embodiments, the oral carrier includes a humectant and surfactant. Generally, if alcohol is present, the weight ratio of water to alcohol is in the range of 1:1 to 20:1, preferably 3:1 to 10:1 and more preferably 4:1 to 6:1. The total amount of water-alcohol mixture in this type of preparation is typically in an amount of 70 to 99.9% of the preparation (Ansari at [0022]), which overlaps the instantly claimed range of more than 20%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Ansari teaches the use of stannous fluoride (Ansari at [0059]).
Ansari teaches the use of thickening agents (Ansari at [0068],[0085]).
Ansari does not require copolymers of maleic anhydride or copolymers of maleic acid.
Regarding instant claim 6, Ansari teaches the use of sodium phosphate dibasic, potassium phosphate dibasic, dicalcium phosphate dihydrate, calcium pyrophosphate, tetrasodium pyrophosphate, tetrapotassium pyrophosphate, sodium tripolyphosphate, and mixtures of any of two or more of these (Ansari at [0061]).
Regarding instant claim 7, Ansari teaches the use of tetrasodium pyrophosphate, (Ansari at [0061]).
Regarding instant claim 10, Ansari teaches the use of stannous fluoride (Ansari at [0059]).
Regarding instant claim 11,
Ansari teaches the use of one or more antisensitivity agents, e.g., potassium salts such as potassium nitrate, potassium bicarbonate, potassium chloride, potassium citrate, and potassium oxalate; capsaicin; eugenol; strontium salts; and combinations thereof. Such agents may be added in effective amounts, e.g., from about 1 wt. % to about 20 wt. % by weight based on the total weight of the composition, depending on the agent chosen (Ansari at [0062]), which overlaps the instantly claimed range of 0.1 to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Ansari teaches the use of sodium phosphate dibasic, potassium phosphate dibasic, dicalcium phosphate dihydrate, calcium pyrophosphate, tetrasodium pyrophosphate, tetrapotassium pyrophosphate, sodium tripolyphosphate, and mixtures of any of two or more of these. In a particular embodiment, for example the compositions comprise a mixture of tetrasodium pyrophosphate (Na4P2O7), calcium pyrophosphate (Ca2P2O7), and sodium phosphate dibasic (Na2HPO4), e.g., in amounts of ca. 3-4% of the sodium phosphate dibasic and ca. 0.2-1% of each of the pyrophosphates. In another embodiment, the compositions comprise a mixture of tetrasodium pyrophosphate (TSPP) and sodium tripolyphosphate (STPP) (Na5P3O10), e.g., in proportions of TSPP at about 1-2% and STPP at about 7% to about 10%. Such phosphates are provided in an amount effective to reduce erosion of the enamel, to aid in cleaning the teeth, and/or to reduce tartar buildup on the teeth, for example in an amount of 2-20%, e.g., ca. 5-15%, by weight of the composition (Ansari at [0061]), which overlaps the instantly claimed range of 1.65 to 2.25%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Ansari teaches that arginine, where present, may be present at levels from, e.g., about 0.1 to about 20 weight % (expressed as weight of free base) (Ansari at [0057]), which overlaps the instantly claimed range of 0.1% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 12, Ansari teaches the use of stannous fluoride in an amount of about 0.01 weight % to about 1 weight % (Ansari at [0059]), which overlaps the instantly claimed range of 0.1 to 2%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 33,
Ansari teaches the use of one or more antisensitivity agents, e.g., potassium salts such as potassium nitrate, potassium bicarbonate, potassium chloride, potassium citrate, and potassium oxalate; capsaicin; eugenol; strontium salts; and combinations thereof. Such agents may be added in effective amounts, e.g., from about 1 wt. % to about 20 wt. % by weight based on the total weight of the composition, depending on the agent chosen (Ansari at [0062]), which overlaps the instantly claimed range of about 1 to about 4%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Ansari teaches that arginine, where present, may be present at levels from, e.g., about 0.1 to about 20 weight % (expressed as weight of free base) (Ansari at [0057]), which overlaps the instantly claimed range of about 1% to about 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 35, Ansari teaches the use of carrageenan, xanthan gum and hydroxyethyl cellulose (Ansari at [0085]).
Regarding instant claim 36, Ansari teaches the use of stannous fluoride in an amount of about 0.01 weight % to about 1 weight % (Ansari at [0059]), which overlaps the instantly claimed range of 0.1 to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 37, Ansari teaches that within certain embodiments of the oral compositions, it is also desirable to incorporate a humectant to reduce evaporation and also contribute towards preservation by lowering water activity. Certain humectants can also impart desirable sweetness or flavor to the compositions. The humectant may be present in the composition in an amount of from 10 weight % to 40 weight % in one embodiment. Suitable humectants include edible polyhydric alcohols such as glycerine, sorbitol, xylitol, propylene glycol as well as other polyols and mixtures of these. Typically, the composition of the present invention comprises a combination of glycerine and sorbitol (Ansari at [0071]). This range overlaps the instantly claimed range of 5% to 70%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 38, Ansari teaches that the composition may be a dentifrice (Ansari at [0021]).
Regarding instant claim 39, Ansari teaches the use of one or more antisensitivity agents, e.g., potassium salts such as potassium nitrate, potassium bicarbonate, potassium chloride, potassium citrate, and potassium oxalate; capsaicin; eugenol; strontium salts; and combinations thereof. Such agents may be added in effective amounts, e.g., from about 1 wt. % to about 20 wt. % by weight based on the total weight of the composition, depending on the agent chosen (Ansari at [0062]), which overlaps the instantly claimed range of 2.5 to 3.5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 40, Ansari teaches the use of stannous fluoride (Ansari at [0059]). Ansari teaches the use of tetrasodium pyrophosphate (Ansari at [0061]).
B) Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ansari et al (US Patent Application Publication 20190262254A1) as applied to claims 6-7, 10-12, and 33-40 above, and further in view of Deckner (U.S. 2010/0135932 A1).
The teachings of Ansari are discussed above.
The teachings of Ansari differ from instant claim 9 insofar as they do not specifically teach the stannous source as being stannous pyrophosphate or stannous chloride. The teachings of Deckner cure this deficit.
Deckner teaches an oral care composition comprising stannous chloride and or stannous fluoride in a range of 0.0001% to 11% (Deckner at [0106]). Deckner further teaches the use of potassium nitrate (Deckner at claim 15). Deckner teaches the use of arginine (Deckner at claim 12) in a range of 0.1% to 5% (Deckner at [0116]). Deckner teaches the use of sodium pyrophosphate and tetrasodium pyrophosphate (Deckner at [0104] in a range of 0.1% to 15% by weight of the composition. Deckner teaches the use of water in an amount from 1% to 90% (Deckner at [0175]).
The teachings of Deckner differ from the instant claims insofar as they teach potassium nitrate but do not teach the amount of potassium nitrate present in the composition. The teachings of Ansari cure this deficit.
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. Ansari et al. disclose wherein the oral care composition comprises stannous salts but does not specifically disclose stannous chloride. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the stannous salt of Ansari et al. to have been stannous chloride since that salt is a known and effective stannous salt used in oral care compositions as taught by Deckner.
It would have been prima facie obvious to one of ordinary skill in the art to have combined the stannous chloride of Deckner with the stannous fluoride of Ansari for the predictable outcome of a dentifrice having stannous ions. See MPEP 2144.06(I)
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 6-7,9-12, and 33-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 14-15, 18-19, 24 and 27-28 of copending Application No. 18/258,267. Although the claims at issue are not identical, they are not patently distinct from each other because they teach similar oral care compositions comprising potassium nitrate arginine, water, tetrasodium pyrophosphate, stannous and thickeners. The instant application recites an oral care composition comprising:(i) potassium nitrate; (ii) arginine in free or orally acceptable salt form; (iii) water-soluble alkali metal; (iv) more than 20 wt.% of water; (v) a stannous ion source; and(vi) one or more thickening agents, wherein the oral care composition is free of copolymers of maleic anhydride and free of copolymers of acid.
The reference application recites an oral care composition consisting of:(i) a stannous ion source comprising stannous fluoride, stannous chloride, stannous pyrophosphate, or a combination thereof;(ii) nitric acid, a water-soluble nitrate salt, or a combination thereof;(iii) a water-soluble alkali metal polyphosphate comprising a pyrophosphate;(iv) a basic amino acid comprising about 1 to about 15 wt.% of arginine;and(v) about 10 wt.% or more of water, by weight of the oral care composition;(vi) one or more surfactant;(vii) one or more polvol;(viii) one or more thickening agent;(ix) one or more abrasive; and(x) optionally, a buffer, a sweetener, a flavorant, a pigment, a dye, an anti-caries agent, an anti-bacterial agent, a whitening agent, a desensitizing agent, a preservative, or a mixture of two or more thereof,wherein the oral care composition comprises a molar ratio of the total amount of the nitric acid, the water-soluble nitrate salt, or the combination thereof to the total amount of the stannous ion source of 0.7:1 to 3.4:1 and a molar ratio of the water-soluble alkali metal polyphosphate to the stannous ion source of 1:1 to 1.3:1 (‘267 at claim 1). The reference application recites wherein the water-soluble nitrate salt is selected from an alkali or alkaline earth metal nitrate, zinc nitrate, silver nitrate, ammonium nitrate, and a combination of two or more thereof (‘267 at claim 2). The reference application recites wherein the water-soluble nitrate salt is selected from lithium nitrate, sodium nitrate, potassium nitrate, magnesium nitrate, calcium nitrate, and a combination of two or more thereof (‘267 at claim 3). The reference application recites wherein the water-soluble nitrate salt is potassium nitrate (‘267 at claim 4). The reference application recites wherein the water-soluble alkali metal polyphosphate is present in an amount from about 0.1 to about 5 wt.%, by weight of the oral care composition (‘267 at claim 5). The reference application recites wherein the water-soluble alkali metal polyphosphate is selected from sodium pyrophosphate, potassium pyrophosphate, sodium tripolyphosphate, potassium tripolyphosphate, and a combination of two or more thereof (‘267 at claim 6). The reference application recites wherein the water-soluble nitrate salt is potassium nitrate and the water-soluble alkali metal polyphosphate is tetrasodium pyrophosphate (‘267 at claim 7). The reference application recites wherein the molar ratio of the water-soluble alkali metal polyphosphate to the stannous ion source is 1:1 to 1.3:1 (‘267 at claim 8). The reference application recites wherein the molar ratio of the total amount of nitric acid, the water-soluble nitrate salt, or the combination thereof to the total amount of stannous ion source is about 1:1 to 5:1 (‘267 at claim 9). The reference application recites wherein the oral care composition comprises from about 0.1 to about 2 wt.% of the stannous ion source, by weight of the oral care composition; from about 0.1 to about 5 wt.% of the nitric acid, the water-soluble nitrate salt, or the combination of two or more thereof, by weight of the oral care composition; and from about 0.1 to about 5 wt.% of the water-soluble alkali metal polyphosphate, by weight of the oral care composition (267 at claim 10). The reference application recites wherein the oral care composition comprises from about 10 to about 95 wt.% of water, by weight of the oral care composition (‘267 at claim 11). The reference application recites wherein the oral care composition comprises one or more humectants in an amount from about 5 to about 25 wt.%, by weight of the oral care composition (‘267 at claim 14). The reference application recites wherein the basic amino acid is selected from the following: arginine, glycine, lysine, serine, citrullene, ornithine, creatine, histidine, diaminobutanoic acid, diaminoproprionic acid, and combinations thereof (‘267 at claim 15). The reference application recites further comprising about 0.01 to about 0.09 wt.% of charcoal, by weight of the oral care composition; wherein the composition is formulated as a dentifrice (‘267 at claim 18). The reference application recites wherein the oral care composition is in the form of a single component, single phase oral care composition (‘267 at claim 19). The reference application recites a method of treating or reducing systemic blood pressure, in a subject in need thereof, wherein the method comprises administering an oral care composition of claim 1 to the oral cavity of a person in need thereof (‘267 at claim 24). The reference application recites (‘267 at claim 25). The reference application recites (‘267 at claim 26). The reference application recites an oral care composition comprising:(i) from about 0.1 to about 2 wt.% of a stannous ion source comprising stannous fluoride,stannous chloride, stannous pyrophosphate, or a combination thereof;(ii) nitric acid, a water-soluble nitrate salt, or a combination thereof;(iii) from about 0.1 to about 3 wt.% of tetrasodium pyrophosphate;(iv) a basic amino acid; and (v) about 10 wt.% or more of water, wherein the oral care composition comprises a molar ratio of the total amount of stannous ion source to the total amount of the nitric acid, the water-soluble nitrate salt, or the combination thereof to the total amount of tetrasodium pyrophosphate of about 1:3.4:1 and wherein all weight percentages are based on the total weight of the oral care composition (‘267 at claim 27). The reference application recites n oral care composition consisting of:(i) a stannous ion source comprising stannous fluoride, stannous chloride, stannous pyrophosphate, or a combination thereof;(ii) potassium nitrate;(iii) sodium tripolyphosphate;(iv) a basic amino acid comprising about 1 to about 15 wt.% of arginine; and(v) about 10 wt.% or more of water,(vi)one or more surfactant;(vii) one or more polyol;(viii) one or more thickening agent;(ix) one or more abrasive; and(x) optionally, a buffer, a sweetener, a flavorant, a pigment, a dye, an anti-caries agent, an anti-bacterial agent, a whitening agent, a desensitizing agent, a preservative, or a mixture of two or more thereof, wherein the oral care composition comprises a molar ratio of the total amount of the nitric acid, the water-soluble nitrate salt, or the combination thereof potassium nitrate to the total amount of the stannous ion source of 0.2:1 to 34:1 and a molar ratio of the amount of the sodium tripolyphosphate to the total amount of the stannous ion source of 1:1 to 1:3, and wherein all weight percentages are based on the total weight of the oral care composition (‘267 at claim 28).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are presently allowable.
Correspondence
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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