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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/17/2026 has been entered.
Applicants' arguments, filed 09/17/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 is a CON of PCT/CN2021/085779 filed 04/07/2021.
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.
Claims 1-4 and 7-23 are rejected under 35 U.S.C. 103 as being unpatentable over Winston et al. (US Patent 5455024A).
Winston recites dentifrice in the form of a toothpaste or tooth gel which is free of more soluble zinc salts and their lingering unpleasant metallic and astringent taste and which comprises: a. about 3-70% sodium bicarbonate; b. an effective amount of agglomerated zinc oxide particles, which particles have a median particle size of 50 microns or less, are agglomerated from primary particles having a sub-micron average particle size, and act as an anti-plaque, anti-gingivitis, anti-bacterial and tartar formation inhibiting agent; c. a liquid vehicle in an amount sufficient to provide the desired consistency; and d. an effective amount of an anti-caries agent (Winston at claim 1). Winston recites wherein the anti-caries agent is a fluoride ion source present in an amount capable of providing about 50-3500 ppm of fluoride ions (Winston at claim 2). Winston recites wherein the fluoride ion source is sodium fluoride present in an amount of about 0.2-0.3% (Winston at claim 3). Winston recites wherein the sodium bicarbonate is about 10-65%, the agglomerated zinc oxide particles are about 0.1-10%, and the liquid vehicle is water and as humectant present in an amount of up to about 50% (Winston at claim 4). Winston recites wherein the sodium bicarbonate is about 40-65%, the agglomerated zinc oxide particles are about 1-5%, and the liquid vehicle is about 5-35% (Winston at claim 5). Winston recites wherein the sodium bicarbonate is about 3-60%, the agglomerated zinc oxide particles are about 0.1-10%, and the liquid vehicle is water and a humectant present in an amount of up to about 50% (Winston at claim 6). Winston recites wherein the sodium bicarbonate is about 5-35%, the agglomerated zinc oxide particles are about 1-5%, and the liquid vehicle is about 5-20% (Winston at claim 7). Winston recites wherein the composition further comprises about 5-50% of a humectant; about 0.5-1.0% of an organic or inorganic thickener; about 0.1-2.5% of a surfactant; about 0.5-2% of a flavoring agent; about 0.1-2% of a sweetening agent; and/or an effective amount of an anti-calculus agent (Winston at claim 8). Winston recites wherein the humectant is sorbitol and/or polyethylene glycol; wherein the thickener is carboxymethyl cellulose; wherein the surfactant is sodium lauroyl sulfate and sodium lauryl sarcosinate; and wherein the sweetening agent is sodium saccharin (Winston at claim 9). Winston recites wherein the anti-calculus agent is one or more pyrophosphate salts present in an amount sufficient to provide at least 1.5% pyrophosphate ions (Winston at claim 10). Winston recites wherein the pyrophosphate salt is disodium pyrophosphate, tetrasodium pyrophosphate, or mixtures thereof (Winston at claim 11). Winston recites wherein the pyrophosphate salt is tetrasodium pyrophosphate in an amount of about 2-5.5% (Winston at claim 12). Winston teaches sweetening agents are also useful herein. They include saccharin, sucralose, dextrose, levulose, aspartame, D-tryptophan, dihydrochalcones, acesulfame, sodium cyclamate, and calcium cyclamate. They are generally used in amounts of about 0.1-4% (Winston at column 5 lines 32-48). Winston teaches the use of calcium carbonate as an abrasive in a range of up to 50% (Winston at Colum lines 37-60). Winston teaches the use of silica as a thickener (Winston at column 4 lines 34-36). Winston teaches the composition has a pH of 7.5 to 9.5 (Winston at Column 4 lines 11-17). Winston teaches the use of silica as an abrasive used in the range of up to about 50% (Winston at column 4 lines 37-60).
Winston 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. Winston 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 Winston to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
Regarding instant claim 1-3, Winston recites dentifrice in the form of a toothpaste or tooth gel which comprises: about 3-70% sodium bicarbonate, a liquid vehicle, and an effective amount of an anti-caries agent (Winston at claim 1), which overlaps the instantly claimed range of about 20% to about 60%. 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). Winston recites wherein the anti-caries agent is a fluoride ion source present in an amount capable of providing about 50-3500 ppm of fluoride ions (Winston at claim 2). Winston recites wherein the sodium bicarbonate is about 10-65%, the agglomerated zinc oxide particles are about 0.1-10%, and the liquid vehicle is water and as humectant present in an amount of up to about 50% (Winston at claim 4). Winston teaches the use of saccharin and sucralose as sweeteners in an amount of 0.1% to 4% (Winston at column 5 lines 32-48). Sweeteners in this range would be able to have the instantly claimed ratio of saccharin to sucralose. It would be prima facie obvious to have optimized the amount of each sweetener in the composition in order to get the desired sweetness of the composition. See MPEP 2144.05(II). Winston recites wherein the humectant is sorbitol and/or polyethylene glycol (Winston at claim 9). Winston does not require the use of glycerin or sorbitol as humectants, it teaches alternates like polyethylene glycol.
Regarding instant claim 4, Winston recites wherein the sodium bicarbonate is about 10-65%, the agglomerated zinc oxide particles are about 0.1-10%, and the liquid vehicle is water and as humectant present in an amount of up to about 50% (Winston at claim 4). Winston recites wherein the sodium bicarbonate is about 40-65%, the agglomerated zinc oxide particles are about 1-5%, and the liquid vehicle is about 5-35% (Winston at claim 5), which overlaps the instantly claimed range of about 15% to about 55%. 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). Winston recites wherein the fluoride ion source is sodium fluoride present in an amount of about 0.2-0.3% (Winston at claim 3), which overlaps the instantly claimed range of 0.0025% to about 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). Winston teaches the use of saccharin and sucralose as sweeteners in an amount of 0.1% to 4% (Winston at column 5 lines 32-48), which overlaps the instantly claimed ranges. 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 7-9, Winston teaches sweetening agents are also useful herein. They include saccharin, aspartame, and acesulfame. They are generally used in amounts of about 0.1-4% (Winston at column 5 lines 32-48), which overlaps the instantly claimed range of about 0.1% to about 0.7%. 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 10-12, Winston teaches sweetening agents are also useful herein. They include sucralose and dihydrochalcones. They are generally used in amounts of about 0.1-4% (Winston at column 5 lines 32-48), which overlaps the instantly claimed range of about 0.05% to about 0.7%. 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 13, Winston recites wherein the sodium bicarbonate is about 10-65%, the agglomerated zinc oxide particles are about 0.1-10%, and the liquid vehicle is water and as humectant present in an amount of up to about 50% (Winston at claim 4). Winston recites wherein the sodium bicarbonate is about 40-65%, the agglomerated zinc oxide particles are about 1-5%, and the liquid vehicle is about 5-35% (Winston at claim 5), which overlaps the instantly claimed range of about 20% to about 50%. 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 14, Winston teaches the use of silica as an abrasive used in the range of up to about 50% (Winston at column 4 lines 37-60), which overlaps the instantly claimed range of about 20% to about 50%. 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 15, Winston teaches the composition has a pH of 7.5 to 9.5 (Winston at Column 4 lines 11-17), which lies within the instantly claimed range of greater than 7.3. 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 16, Winston recites dentifrice in the form of a toothpaste or tooth gel which comprises: about 3-70% sodium bicarbonate, a liquid vehicle, and an effective amount of an anti-caries agent (Winston at claim 1)
Regarding instant claim 17, Winston teaches the use of silica as a thickener (Winston at column 4 lines 34-36).
Regarding instant claim 18, Winston recites wherein the humectant is sorbitol and/or polyethylene glycol; wherein the thickener is carboxymethyl cellulose; wherein the surfactant is sodium lauroyl sulfate and sodium lauryl sarcosinate; and wherein the sweetening agent is sodium saccharin (Winston at claim 9).
Regarding instant claim 19-20, Winston teaches the use of calcium carbonate as an abrasive in a range of up to 50% (Winston at Colum 4 lines 37-60), which overlaps the instantly claimed range of about 5% to about 50%. 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 21, Winston recites wherein the fluoride ion source is sodium fluoride present in an amount of about 0.2-0.3% (Winston at claim 3).
Regarding instant claim 22, Winston teaches that fluoride may be used in a range of 0.05 to 0.65% (Winston at column 6 Lines 10-30), which overlaps the instantly claimed range of about 0.5% to about 1.5%. 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 23, Winston recites dentifrice in the form of a toothpaste or tooth gel which comprises: about 3-70% sodium bicarbonate, a liquid vehicle, and an effective amount of an anti-caries agent (Winston at claim 1)
Relevant Prior Art
Winston et al (US Patent 5,385,727 A)
Winston recites dentifrice in the form of a toothpaste or tooth gel comprising: a. about 3-70% sodium bicarbonate; b. an effective amount of zinc oxide particles; and c. a liquid vehicle in an amount sufficient to provide the desired consistency, said dentifrice being free of more soluble zinc salts and their lingering unpleasant metallic and astringent taste, said zinc oxide particles being agglomerated and having a medium particle size of 50 microns or less and being agglomerated from zinc oxide primary particles having sub-micron average particle size, and whose release of zinc ions is effective primarily as an antiplaque, anti-gingivitis, antibacterial and tartar formation inhibiting agent and whose release to kill the bacteria and prevent tartar formation is free from the lingering unpleasant metallic and astringent taste of most zinc salts when they are also absent (Winston at claim 1). Winston recites wherein the sodium bicarbonate is about 10-65%, the zinc oxide particles are about 0.1-10%, and the liquid vehicle is water in an amount of up to about 50% (Winston at claim 2). Winston recites wherein the sodium bicarbonate is about 40-65%, the zinc oxide particles are agglomerated particles present in an amount of about 1-5%, and the water is about 5-35% (Winston at claim 3). Winston recites in the form of a gel, wherein the sodium bicarbonate is about 3-60%, the zinc oxide particles are about 0.1-10%, and the liquid vehicle is water in an amount of up to about 50% (Winston at claim 4). Winston recites wherein the sodium bicarbonate is about 5-35%, the zinc oxide particles are agglomerated zinc oxide particles present in an amount of about 1-5%, and the water is about 5-20% (Winston at claim 5). Winston recites a method of inhibiting plaque formation by adding to a dentifrice containing sodium bicarbonate, which is selected from the group consisting of a toothpaste, and a gel, about 0.1-10% by weight of zinc oxide particles, said dentifrice being free of more soluble zinc salts and their lingering unpleasant metallic and astringent taste, said zinc oxide particles being agglomerated and having a medium particle size of 50 microns or less and being agglomerated from zinc oxide primary particles having sub-micron average particle size, and whose release of zinc ions is effective primarily as an antiplaque, anti-gingivitis, antibacterial and tartar formation inhibiting agent and whose release to kill the bacteria and prevent tartar formation is free from the lingering unpleasant metallic and astringent taste of most zinc salts when they are also absent (Winston at claim 6). Winston recites wherein the zinc oxide particles are agglomerated particles present in an amount of about 1-5% (Winston at claim 7). Winston teaches that sweetening agents are also useful herein. They include saccharin, sucralose, dextrose, levulose, aspartame, D-tryptophan, dihydrochalcones, acesulfame, sodium cyclamate, and calcium cyclamate. They are generally used in amounts of about 0.1-4% (Winston at column 5).Winston teaches the use of fluoride in a range of up to about 5% (Winston at column 6).Winston teaches the use of abrasive silicas and calciums in an amount of up to 50% (Winston at columns 4-5).Winston teaches the use of thickening silicas and polymers (Winston at column 4).
Stier (US Patent Application Publication 20040101490A1)
Stier recites an oral composition comprising sodium bicarbonate, an ion-channel competitor, an initial sweetener, and a delayed sweetener, wherein the ion-channel competitor, initial sweetener, and delayed sweetener are present in amounts which are effective to abate or eliminate the salty taste ordinarily imparted by the sodium bicarbonate (Stier at claim 1). Stier recites wherein the initial sweetener is selected from the group consisting of saccharin, sucralose, neotame, alitame, aspartame, cyclamate, thaumatin, a dihydrochalcone, and an acesulfame potassium compound (Stier at claim 7). Stier recites wherein the initial sweetener includes saccharin (Stier at claim 8). Stier recites wherein the saccharin is present in an amount of from about 0.10% to about 0.80% of the total weight of the oral composition (Stier at claim 9). Stier recites a method of masking the salty taste of sodium bicarbonate in an oral composition comprising the step of adding to the oral composition an effective amount of an ion-channel competitor, an effective amount of an initial sweetener, and an effective amount of a delayed sweetener (Stier at claim 17). Stier teaches that the oral composition or dentifrice of the invention also includes an initial sweetener that provides an initial, intense sweetness to help abate or eliminate the customary salty taste of sodium bicarbonate. Examples of the initial sweetener include, but are not limited to: saccharin; sucralose; neotame; alitame; aspartame; cyclamate; thaumatin; dihydrochalcones; and acesulfame potassium (acesulfame K) compounds. Preferably, the initial sweetener is or includes saccharin. The intensity of the sweetness which is rapidly imparted by the initial sweetener declines rapidly with time (Stier at [0026]).Stier teaches that the amount of initial sweetener to be included in the oral composition or dentifrice of the invention is any amount which is effective to mask the customary salty taste attributable to sodium bicarbonate, when combined with effective amounts of the ion-channel competitor and the delayed sweetener. For example, when the initial sweetener comprises saccharin, the amount of saccharin to be included in the oral composition or dentifrice is preferably from about 0.10% to about 0.80% of the total weight of the oral composition or dentifrice, and most preferably about 0.60% of the total weight of the oral composition or dentifrice (Stier at [0027]).Stier teaches that the oral composition or dentifrice of the invention includes a delayed sweetener that provides a less intense sweetness initially which builds in intensity over time to extend the sweetness profile and help abate or eliminate the customary salty taste of sodium bicarbonate (Stier at [0028]).Stier teaches the use of abrasives (Stier at [0035]).Stier teaches thickeners (Stier at [0037]).Stier teaches the use of fluoride (Stier at [0038]).
The relevant prior art is presented for completeness of the record and compact prosecution. In selecting the references to be used in rejecting the claims, the examiner should carefully compare the references with one another and with the applicant’s disclosure to avoid an unnecessary number of rejections over similar references. The examiner is not called upon to cite all references that may be available, but only the "best." (See 37 CFR 1.104(c).) Multiplying references, any one of which is as good as, but no better than, the others, adds to the burden and cost of prosecution and should therefore be avoided. See MPEP 904.03, third paragraph in section. The examiner takes the position that Winston appears to be just as good as Winston 727 and Stier. As such, no rejection over Winston 727 and Stier has been written in view of the provisions of MPEP 904.03.
Response to Arguments
Applicant's arguments filed 09/17/2026 have been fully considered but they are not persuasive.
Applicant argues that Winston discloses that suitable humectants include glycerin and sorbitol. Pending claim 1 recites a composition that is free of humectants selected from glycerin and sorbitol. Winston does not teach or suggest this limitation. To the contrary, Winston expressly describes a humectant as a "desirable component." Applicant submits that this disclosure would discourage a person of ordinary skill in the art from formulating Winston's composition without glycerin or sorbitol. See Spectralytics, Inc. V. Cordis Corp., 649 F.3d 1336, 1343 (Fed. Cir. 2011). Therefore, the obviousness rejection should be withdrawn.
The Examiner does not agree. Winston does not require the use of glycerin or sorbitol. Glycerin and Sorbitol are optional or preferred by Winston. Winston recites wherein the humectant is sorbitol and/or polyethylene glycol (Winston at claim 9). Winston does not require the use of glycerin or sorbitol as humectants, it teaches alternatives like polyethylene glycol. The prior art is good for all it contains including general teachings, alternatives and non-preferred embodiments. "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." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). See MPEP 2123(I). The teaching of preferred embodiments does not teach away from the general teachings of non-glycerin or non-sorbitol humectants like polyethylene glycol. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2123(II). As such, Applicant’s arguments are not persuasive and the obviousness rejection is maintained.
Applicant argues that the instant application provides an unexpected benefit in sensory experience and biofilm reduction. Therefore, the obviousness rejection should be withdrawn.
The Examiner does not agree. Neither Composition 6 nor Composition 7 fall within the amended instantly claimed ranges. Both Composition 6 and Composition 7 contain glycerin which is prohibited by the amended instant claim 1.
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As such, there is no nexus between Compositions 6 and 7 of the Instant Specification and the instant claims. Applicant or patent owner bears the burden of establishing a nexus between the objective evidence of nonobviousness and the claimed invention. See In re Huang, 100 F.3d 135, 140, 40 USPQ 1685, 1689 (Fed. Cir. 1996). Nexus is presumed when the applicant or patent owner shows that the asserted objective evidence of record is tied to a certain product and that product includes the claimed features and is coextensive with them. See Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373, 2019 USPQ2d 483355 (Fed. Cir. 2019), cert. denied, 141 S.Ct. 373 (2020). See MPEP706.01(b). As such, the results of Table 2 share no nexus with the amended claims.
Were there a nexus between the claims and Compositions 6 and 7, then the burden is on Applicant to explain the data offered in the instant specification and drawings. "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). See MPEP 716.02(b)(II). It is currently unclear what the results of data in the instant specification are and how they are statistically and practically significant. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). See MPEP 716.02(b)(I). The compositions of the instant specification at Table 1 have very different compositions making it difficult to determine which factor or component is driving the results. Table 2 of the instant specification does not provide statistical or practical significance for the results. It is unclear if there is a practical or statistical difference between a thickness of 26.9, 27.8 and 23.8. Because no practical or statistical difference is established no case of unexpected results is established.
Examiner would like to note that regarding the difference in taste between Composition 5 and Composition 4, it would be helpful if the data with regards to taste for a composition with no sodium saccharin, just sucralose were reported. Composition 4 reports just sodium saccharin and Composition 5 reports both sodium saccharin and sucralose. Having the taste data for a composition with no sodium saccharin, just sucralose in an affidavit or declaration would allow for the determination of unexpected or synergistic results. As an example, if a composition with no sodium saccharin just sucralose measured a 0 or 2 than Composition 5 would show a synergistic relationship between sodium saccharin and sucralose. Where as, if a composition with no sodium saccharin just sucralose measured a 4 or a 5 it would just be the combination of two sweeteners and not synergy with regards to taste. Because no nexus is present between the claims and Compositions 6 and 7 and no unexpected results are established the obviousness rejections stand. As such, Applicant’s arguments are not persuasive and the obviousness rejection stands.
Conclusion
No claims are presently allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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