DETAILED ACTION
Applicants' arguments, filed 10/02/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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.
Information Disclosure Statement
The information disclosure statement (IDS) dated 12/04/2025 complies with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
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 1-23 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 1% 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).
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 5, Winston recites wherein the sodium bicarbonate is about 10-65%, (Winston at claim 4), which overlaps the instantly claimed range of about 10% 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 6, Winston recites wherein the humectant present is in an amount of up to about 50% (Winston at claim 4), which overlaps the instantly claimed range of from 0% to about 10%. 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 humectant is sorbitol and/or polyethylene glycol (Winston at claim 9).
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 hoverlaps the instnalty 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)
Response to Arguments
Applicant's arguments filed 10/02/2025 have been fully considered but they are not persuasive.
Applicant argues that the sodium bicarbonate of Winston is used for a different purpose and therefore the obviousness rejection should be withdrawn.
The Examiner does not agree. Winston recites wherein the sodium bicarbonate is about 10-65%, (Winston at claim 4). The prior art is does not need to use the sodium bicarbonate for the same reason or to solve the same problem as the instant application. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). See MPEP 2144(IV). As such, Applicant’s arguments are not persuasive and the obviousness rejection stands.
Applicant argues that Winston does not recognize the advantage of using the high and medium speed sweeteners together in a specific ratio and that Winston does not recognize the problem of the instant application. Therefore, the obviousness rejection should be withdrawn.
The Examiner does not agree. 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). "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). See MPEP 2112(I). Winston does not need to recognize the problem of the instant application, it offers the same solution a combination of sucralose and saccharin, which one of ordinary skill in the art would have optimized for the desired sweetness. As such, Applicant’s arguments are not persuasive and the obviousness rejection stands.
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. 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. As such, Applicant’s arguments are not persuasive and the obviousness rejection stands.
Conclusion
No claims are presently allowable.
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.
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