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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/13/2026 has been entered.
Applicants' arguments, filed 02/13/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 foreign priority to EP20193325.6 filed on 08/28/2020. The instant application is a 371 of PCT/EP2021/073638 filed in 08/26/2021.
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.
A) Claims 1, 3-7, 13-20, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Hara et al (US Patent Application Publication 20150342838A1).
Hara teaches that an optimal amount of water is in the range of 10% to 25% by weight (Hara at [0050]). Hara teaches that the composition may contain a humectant to prevent congelation and separation and make the oral cavity care composition moist. Specific examples of the humectant include sorbitol, glycerin, ethylene glycol, propylene glycol, 1,3-butyleneglycol, propanediol, polyethyleneglycol, and trehalose. Glycerin and sorbitol are preferable. These humectants may be used singly or in combination. The content of the humectant is 5% to 90% by weight and preferably 10% to 70% by weight, with respect to the oral cavity care composition ([0129]). Hara teaches that the composition may contain an abrasive to polish the tooth substance and remove plaque and the like. Specific examples of the abrasive include aluminum hydroxide, silicic anhydride, alumina, silica gel, hydrated silicate, aluminum silicate, titanium dioxide, and aluminum lactate. Silicic anhydride that is not reactive with the ions sustained-released from the ion sustained-release filler is preferable. These abrasives may be used singly or in combination. The content of the abrasive is 0% to 60% by weight and preferably 0% to 40% by weight, with respect to the oral cavity care composition (Hara at [0130]). Hara teaches that the composition may contain a foaming agent that has an effect of promptly dispersing the composition components in the oral cavity after the application into the oral cavity. Specific examples include sodium laurylsulfate, N-sodium lauroylsarcosine, a nonionic surfactant, and an amphoteric surfactant. Sodium lauryl sulfate is preferable. These foaming agents may be used singly or in combination. The content of the foaming agent is 0% to 10% by weight and preferably 0% to 5% by weight, with respect to the oral cavity care composition (Hara at [0131]). Hara teaches the use of kaolin (Hara at [0233], [0266]). Hara teaches that the kaolin may be used as a filling material and that filling material may have any shape such as spherical, acicular, platy, crushed, or scaly. The average particle diameter (50%) of the filling material is not particularly limited so long as it is in the range of 0.1 μm to 100 μm. A preferable range is 1 μm to 50 μm, and a more preferable range is 1 μm to 10 μM (Hara at [0235]). Hara teaches that the content of the filling material is preferably in the range of 1% to 50% by weight and more preferably in the range of 1% to 20% by weight (Hara at [0237],[0269]). Hara teaches that inorganic coloring agents include titanium oxide, rutile titanium, anatase titanium, zinc oxide, aluminum oxide, zinc sulfide, yellow iron oxide, ultramarine blue, red iron oxide, carbon black, and graphite. These coloring agents may be used singly or in combination (Hara at [0090]). Hara teaches the use of fluoride salts which include lithium fluoride, sodium fluoride, potassium fluoride, rubidium fluoride, cesium fluoride, beryllium fluoride, magnesium fluoride, calcium fluoride, strontium fluoride, barium fluoride, aluminum fluoride, manganese(II) fluoride, iron(II) fluoride, iron(III) fluoride, silver(I) fluoride, diammine silver fluoride, sodium hydrogenfluoride, potassium hydrogenfluoride, sodium fluorophosphates, potassium hexafluorotitanate, sodium hexafluorosilicate, sodium hexafluorophosphate, pentafluoro-2-sodium stannate(II), and potassium hexafluorozirconate. Of these examples of the fluoride salt, lithium fluoride, sodium fluoride, potassium fluoride, magnesium fluoride, calcium fluoride, strontium fluoride, barium fluoride, and calcium fluoride are preferable, and sodium fluoride is most preferable. To control the amount of ion such as the fluoride ion flowing out from the fluoride salt, a fluoride salt functionalized by surface treatment, surface coating, etc. may be used without any limitation. An example of the plant-derived fluorine compound is tea extract fluorine extracted from tea leaves. The fluoride ion supply materials may be used singly or in combination. The blending quantity of the fluoride ion supply material is preferably 0.1% to 10% (Hara at [0062]). Hara teaches the application of the composition to teeth (Hara at Examples).
Hara 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. Hara 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 Hara to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
Regarding instant claim 1, Hara teaches that an optimal amount of water is in the range of 10% to 25% by weight (Hara at [0050]), which overlaps with the instantly claimed range of 1 to 30%. 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).
Hara teaches that the composition may contain a humectant to prevent congelation and separation and make the oral cavity care composition moist. Specific examples of the humectant include sorbitol, glycerin, ethylene glycol, propylene glycol, 1,3-butyleneglycol, propanediol, polyethyleneglycol, and trehalose. Glycerin and sorbitol are preferable. These humectants may be used singly or in combination. The content of the humectant is 5% to 90% by weight and preferably 10% to 70% by weight, with respect to the oral cavity care composition ([0129]), which overlaps the instantly claimed range of 25 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).
Hara teaches that the composition may contain an abrasive to polish the tooth substance and remove plaque and the like. Specific examples of the abrasive include aluminum hydroxide, silicic anhydride, alumina, silica gel, hydrated silicate, aluminum silicate, titanium dioxide, and aluminum lactate. Silicic anhydride that is not reactive with the ions sustained-released from the ion sustained-release filler is preferable. These abrasives may be used singly or in combination. The content of the abrasive is 0% to 60% by weight and preferably 0% to 40% by weight, with respect to the oral cavity care composition (Hara at [0130]), which overlaps the instantly claimed range of 25 to 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).
Hara teaches that the composition may contain a foaming agent that has an effect of promptly dispersing the composition components in the oral cavity after the application into the oral cavity. Specific examples include sodium laurylsulfate, N-sodium lauroylsarcosine, a nonionic surfactant, and an amphoteric surfactant. Sodium lauryl sulfate is preferable. These foaming agents may be used singly or in combination. The content of the foaming agent is 0% to 10% by weight and preferably 0% to 5% by weight, with respect to the oral cavity care composition (Hara at [0131]), which overlaps the instantly claimed range. 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).
Hara teaches that an optimal amount of water is in the range of 10% to 25% by weight (Hara at [0050]). The content of the humectant is 5% to 90% by weight and preferably 10% to 70% by weight, with respect to the oral cavity care composition ([0129]). The composition of Hara with these two ranges is capable of a ratio of water to humectant that lies within the instantly claimed range of 0.3 to 0.6. 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).
Hara teaches that the composition may contain an abrasive to polish the tooth substance and remove plaque and the like. Specific examples of the abrasive include aluminum hydroxide, silicic anhydride, alumina, silica gel, hydrated silicate, aluminum silicate, titanium dioxide, and aluminum lactate. Silicic anhydride that is not reactive with the ions sustained-released from the ion sustained-release filler is preferable. These abrasives may be used singly or in combination. The content of the abrasive is 0% to 60% by weight and preferably 0% to 40% by weight, with respect to the oral cavity care composition (Hara at [0130]). Hara teaches the use of kaolin (Hara at [0233], [0266]). Hara teaches that the kaolin may be used as a filling material and that filling material may have any shape such as spherical, acicular, platy, crushed, or scaly. The average particle diameter (50%) of the filling material is not particularly limited so long as it is in the range of 0.1 μm to 100 μm. A preferable range is 1 μm to 50 μm, and a more preferable range is 1 μm to 10 μM (Hara at [0235]). Hara teaches that the content of the filling material is preferably in the range of 1% to 50% by weight and more preferably in the range of 1% to 20% by weight (Hara at [0237],[0269]).
Hara teaches that the composition may contain an abrasive to polish the tooth substance and remove plaque and the like. Specific examples of the abrasive include aluminum hydroxide, silicic anhydride, alumina, silica gel, hydrated silicate, aluminum silicate, titanium dioxide, and aluminum lactate. Silicic anhydride that is not reactive with the ions sustained-released from the ion sustained-release filler is preferable. These abrasives may be used singly or in combination. The content of the abrasive is 0% to 60% by weight and preferably 0% to 40% by weight, with respect to the oral cavity care composition (Hara at [0130]). Hara teaches the use of kaolin (Hara at [0233], [0266]) which overlaps with the instantly claimed range of 0.5 to 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 3, Hara teaches that the kaolin may be used as a filling material and that filling material may have any shape such as spherical, acicular, platy, crushed, or scaly. The average particle diameter (50%) of the filling material is not particularly limited so long as it is in the range of 0.1 μm to 100 μm. A preferable range is 1 μm to 50 μm, and a more preferable range is 1 μm to 10 μM (Hara at [0235]). Therefore, Hara teaches a range of kaolin that can fall within the claimed range. 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 4, Hara teaches that the kaolin may be used as a filling material and that filling material may have any shape such as spherical, acicular, platy, crushed, or scaly. The average particle diameter (50%) of the filling material is not particularly limited so long as it is in the range of 0.1 μm to 100 μm. A preferable range is 1 μm to 50 μm, and a more preferable range is 1 μm to 10 μM (Hara at [0235]). Therefore, Hara teaches a range of kaolin that can fall within the claimed range. 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, Hara teaches that the composition may contain an abrasive to polish the tooth substance and remove plaque and the like. Specific examples of the abrasive include aluminum hydroxide, silicic anhydride, alumina, silica gel, hydrated silicate, aluminum silicate, titanium dioxide, and aluminum lactate. Silicic anhydride that is not reactive with the ions sustained-released from the ion sustained-release filler is preferable. These abrasives may be used singly or in combination. The content of the abrasive is 0% to 60% by weight and preferably 0% to 40% by weight, with respect to the oral cavity care composition (Hara at [0130]). Hara teaches the use of kaolin (Hara at [0233], [0266]). Hara teaches that the content of the filling material is preferably in the range of 1% to 50% by weight and more preferably in the range of 1% to 20% by weight (Hara at [0237],[0269]). Therefore, Hara teaches a range of kaolin and silicas that can fall within the claimed range. 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, Hara teaches that the composition may contain an abrasive to polish the tooth substance and remove plaque and the like. Specific examples of the abrasive include aluminum hydroxide, silicic anhydride, alumina, silica gel, hydrated silicate, aluminum silicate, titanium dioxide, and aluminum lactate. Silicic anhydride that is not reactive with the ions sustained-released from the ion sustained-release filler is preferable. These abrasives may be used singly or in combination. The content of the abrasive is 0% to 60% by weight and preferably 0% to 40% by weight, with respect to the oral cavity care composition (Hara at [0130]). Hara teaches the use of kaolin (Hara at [0233], [0266]). Hara teaches that the kaolin may be used as a filling material and that filling material may have any shape such as spherical, acicular, platy, crushed, or scaly. The average particle diameter (50%) of the filling material is not particularly limited so long as it is in the range of 0.1 μm to 100 μm. A preferable range is 1 μm to 50 μm, and a more preferable range is 1 μm to 10 μM (Hara at [0235]). Hara teaches that the content of the filling material is preferably in the range of 1% to 50% by weight and more preferably in the range of 1% to 20% by weight (Hara at [0237],[0269]). Therefore, Hara teaches a range of kaolin and silicas that can fall within the claimed range. 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, Hara does not require the use of any specific abrasives. Hara does teach the use of kaolin (Hara at [0233], [0266]) and silicas (Hara at [0130]).
Regarding instant claim 13, Hara teaches that the composition may contain an abrasive to polish the tooth substance and remove plaque and the like. Specific examples of the abrasive include aluminum hydroxide, silicic anhydride, alumina, silica gel, hydrated silicate, aluminum silicate, titanium dioxide, and aluminum lactate. Silicic anhydride that is not reactive with the ions sustained-released from the ion sustained-release filler is preferable. These abrasives may be used singly or in combination. The content of the abrasive is 0% to 60% by weight and preferably 0% to 40% by weight, with respect to the oral cavity care composition (Hara at [0130]), which overlaps the instantly claimed range of 0.5 to 1.5wt%. 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, Hara teaches that inorganic coloring agents include titanium oxide, rutile titanium, anatase titanium, zinc oxide, aluminum oxide, zinc sulfide, yellow iron oxide, ultramarine blue, red iron oxide, carbon black, and graphite. These coloring agents may be used singly or in combination (Hara at [0090]).
Regarding instant claim 15, Hara teaches the use of fluoride salts which include lithium fluoride, sodium fluoride, potassium fluoride, rubidium fluoride, cesium fluoride, beryllium fluoride, magnesium fluoride, calcium fluoride, strontium fluoride, barium fluoride, aluminum fluoride, manganese(II) fluoride, iron(II) fluoride, iron(III) fluoride, silver(I) fluoride, diammine silver fluoride, sodium hydrogenfluoride, potassium hydrogenfluoride, sodium fluorophosphates, potassium hexafluorotitanate, sodium hexafluorosilicate, sodium hexafluorophosphate, pentafluoro-2-sodium stannate(II), and potassium hexafluorozirconate. Of these examples of the fluoride salt, lithium fluoride, sodium fluoride, potassium fluoride, magnesium fluoride, calcium fluoride, strontium fluoride, barium fluoride, and calcium fluoride are preferable, and sodium fluoride is most preferable (Hara at [0062]).
Regarding instant claim 16, Hara recites a composition with components in overlapping ranges which would be capable of producing the instantly recited range of water activity. See MPEP 2112.01. See MPEP 2144.05.
Regarding instant claim 17, Hara recites a composition with components in overlapping ranges which would be capable of producing the instantly recited range of water activity. See MPEP 2112.01. See MPEP 2144.05.
Regarding instant claim 18, Hara recites a composition with components in overlapping ranges which would be capable of producing the instantly recited range of disc consistency. See MPEP 2112.01. See MPEP 2144.05.
Regarding instant claim 19, Hara recites a composition with components in overlapping ranges which would be capable of producing the instantly recited range of disc consistency. See MPEP 2112.01. See MPEP 2144.05.
Regarding instant claim 20, Hara recites a composition with components in overlapping ranges which would be capable of producing the instantly recited range of flow rate. See MPEP 2112.01. See MPEP 2144.05.
Regarding instant claim 23, Hara teaches that the composition may contain a foaming agent that has an effect of promptly dispersing the composition components in the oral cavity after the application into the oral cavity. Specific examples include sodium lauryl sulfate, N-sodium lauroylsarcosine, a nonionic surfactant, and an amphoteric surfactant. Sodium lauryl sulfate is preferable (Hara at [0131]).
Regarding instant claim 24, Hara teaches the application of the composition to teeth (Hara at Examples).
B) Claims 8-11 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Hara et al (US Patent Application Publication 20150342838A1) as applied to claims 1, 3-7, 13-20, and 23-24 above, and further in view of Midha et al (US Patent Application Publication 20140308323A1).
The teachings of Hara are discussed above. Hara further teaches that the composition may contain a thickener to integrate the powder component and the liquid component to provide proper viscosity. Specific examples include carboxymethylcellulose sodium, hydroxyethylcellulose, hydroxypropylmethylcellulose, xanthan gum, polyvinyl alcohol, sodium polyacrylate, carboxyvinyl polymer, and gelatin. Carboxymethylcellulose sodium is preferable. These thickeners may be used singly or in combination. The content of the thickener is 0.1% to 10% by weight and preferably 0.5% to 5% by weight, with respect to the oral cavity care composition (Hara at [0132]).
The teachings of Hara differ from the instant application insofar as they do not teach the use of cetyl or stearyl alcohol. The teachings of Midha cure this deficit.
Midha recites an oral composition, said composition comprising: a. at least 0.01%, by weight of the composition, of an abrasive comprising one or more polymethylsilsesquioxane particles having an average volume weighted mean particle size of from about 1 to about 20 microns; b. at least 0.01%, by weight of the composition, of an oral care active wherein the active comprises at least one fluoride ion source; and c. from 0.001% to about 99%, by weight of the composition, of an orally acceptable carrier; wherein the polymethylsilsesquioxane particles are substantially insoluble in the composition (Midha at claim 1). Midha recites wherein the orally acceptable carrier is selected from buffering agents, secondary abrasive materials, alkali metal bicarbonate salts, thickening agents, gel networks, humectants, water, surfactants, titanium dioxide, flavor agents, coolants, sweetening agents, coloring agents, other suitable materials, and mixtures thereof (Midha at claim 10). Midha recites a secondary abrasive selected from calcium pyrophosphate, precipitated silica, fused silica, and mixtures thereof (Midha at claim 11). Midha teaches that the oral care compositions herein may include one or more thickening agents, such as a polymeric thickener. Thickening agents may be used in an amount from about 0.1% to about 5%, by weight of the total oral composition. Midha teaches that the thickener may be cetyl/stearyl alcohol, hydroxyethyl cellulose, laponite and water soluble salts of cellulose ethers such as sodium carboxymethylcellulose and sodium carboxymethyl hydroxyethyl cellulose (Midha at [0102-0106]). Midha further teaches the use of a fatty amphiphile like cetyl alcohol and or stearyl alcohol in an amount from about 0.3% to about 5% (Midha at [0107-0108]).
The teachings of Midha differ from the instant invention insofar as it does not teach the use of kaolin. The teachings of Hara cure this deficit.
It would have been obvious for one of ordinary skill in the art to have combined the thickener of Midha, cetyl/stearyl alcohol, with the thickeners of Hara, for the predictable results of a thickener for a toothpaste comprising water, humectants, surfactants, abrasives, fluoride, and titanium dioxide. See MPEP 2144.06(I).
Regarding instant claim 8-11, Hara further teaches that the composition may contain a thickener to integrate the powder component and the liquid component to provide proper viscosity. Specific examples include carboxymethylcellulose sodium, hydroxyethylcellulose, hydroxypropylmethylcellulose, xanthan gum, polyvinyl alcohol, sodium polyacrylate, carboxyvinyl polymer, and gelatin. Carboxymethylcellulose sodium is preferable. These thickeners may be used singly or in combination. The content of the thickener is 0.1% to 10% by weight and preferably 0.5% to 5% by weight, with respect to the oral cavity care composition (Hara at [0132]). Midha teaches that the oral care compositions herein may include one or more thickening agents, such as a polymeric thickener. Thickening agents may be used in an amount from about 0.1% to about 5%, by weight of the total oral composition. Midha teaches that the thickener may be cetyl/stearyl alcohol, hydroxyethyl cellulose, laponite and water soluble salts of cellulose ethers such as sodium carboxymethylcellulose and sodium carboxymethyl hydroxyethyl cellulose (Midha at [0102-0106]). Midha further teaches the use of a fatty amphiphile like cetyl alcohol and or stearyl alcohol in an amount from about 0.3% to about 5% (Midha at [0107-0108]).
Regarding instant claim 22, Hara teaches that an optimal amount of water is in the range of 10% to 25% by weight (Hara at [0050]), which overlaps with the instantly claimed range of 1 to 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).
Hara teaches that the composition may contain a humectant to prevent congelation and separation and make the oral cavity care composition moist. Specific examples of the humectant include sorbitol, glycerin, ethylene glycol, propylene glycol, 1,3-butyleneglycol, propanediol, polyethyleneglycol, and trehalose. Glycerin and sorbitol are preferable. These humectants may be used singly or in combination. The content of the humectant is 5% to 90% by weight and preferably 10% to 70% by weight, with respect to the oral cavity care composition ([0129]), which overlaps the instantly claimed range of 13 to 46% of glycerol and 0 to 25% sorbitol. 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).
Hara teaches the use of kaolin (Hara at [0233], [0266]). Hara teaches that the kaolin may be used as a filling material and that filling material may have any shape such as spherical, acicular, platy, crushed, or scaly. Hara teaches that the content of the filling material is preferably in the range of 1% to 50% by weight and more preferably in the range of 0% to 15% by weight (Hara at [0237],[0269]).
Hara teaches that the composition may contain an abrasive to polish the tooth substance and remove plaque and the like. Specific examples of the abrasive include aluminum hydroxide, silicic anhydride, alumina, silica gel, hydrated silicate, aluminum silicate, titanium dioxide, and aluminum lactate (Hara at [0130]). Midha recites a secondary abrasive selected from calcium pyrophosphate, precipitated silica, fused silica, and mixtures thereof (Midha at claim 11). Hara teaches these abrasives may be used singly or in combination. The content of the abrasive is 0% to 60% by weight and preferably 0% to 40% by weight, with respect to the oral cavity care composition (Hara at [0130]), which overlaps the instantly claimed range of 0 to 30%. 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). It would have been prima facie obvious to have combined the precipitated silica with the silica of Hara for the predictable result of a silica abrasive in an oral care composition. See MPEP 2144.06(I). See MPEP 2144.07. There is a reasonable expectation of success because Midha teaches the use of precipitated silica as a secondary abrasive agent (Midha at [0099]).
Hara teaches that the composition may contain a foaming agent that has an effect of promptly dispersing the composition components in the oral cavity after the application into the oral cavity. Specific examples include sodium laurylsulfate, N-sodium lauroylsarcosine, a nonionic surfactant, and an amphoteric surfactant. Sodium lauryl sulfate is preferable. These foaming agents may be used singly or in combination. The content of the foaming agent is 0% to 10% by weight and preferably 0% to 5% by weight, with respect to the oral cavity care composition (Hara at [0131]), which overlaps the instantly claimed range of 0.05 to 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). Midha further teaches the use of a fatty amphiphile like cetyl alcohol and or stearyl alcohol in an amount from about 0.3% to about 5% (Midha at [0107-0108]).
Hara teaches that inorganic coloring agents include titanium oxide, rutile titanium, anatase titanium, zinc oxide, aluminum oxide, zinc sulfide, yellow iron oxide, ultramarine blue, red iron oxide, carbon black, and graphite. These coloring agents may be used singly or in combination (Hara at [0090]). Midha teaches the use of a coloring agent. The coloring agent may be in the form of an aqueous solution, preferably 1% coloring agent in a solution of water. Pigments, pealing agents, filler powders, talc, mica, magnesium carbonate, calcium carbonate, bismuth oxychloride, zinc oxide, and other materials capable of creating a visual change to the dentifrice compositions may also be used. Color solutions and other agents generally comprise from about 0.01% to about 5%, by weight of the composition. Titanium dioxide may also be added to the present composition. Titanium dioxide is a white powder which adds opacity to the compositions. Titanium dioxide generally comprises from about 0.25% to about 5%, by weight of the composition. It would have been prima facie obvious to have used the metal oxides of Hara in the amounts taught to be useful in an oral care composition by Midha. See MPEP 2144.07. It would have been prima facie obvious for one of ordinary skill in the art to have optimized the amount of metal oxide in the oral care composition to provide a specific or optimized color or pigment. See MPEP2144.05(II).
Response to Arguments
Applicant’s arguments, see remarks, filed 02/13/2026, with respect to the rejection(s) of claims under Strobridge and Strobridge in view of Midha have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hara and Hara in view of Midha.
Applicant's arguments filed 02/13/2026 have been fully considered but they are not persuasive.
Applicant argues that the data of the specification shows benefits to the composition in the forms of usability after drying and good bleeding properties. Therefore, the ratio of humectants to water is critical.
The Examiner does not agree. The claims at present do not specify qualitative or quantitative limitations for bleeding over time, drying over time, or degree of abrasive properties. More than just the ratio of humectant to water goes into the properties of a composition. The compositions of the data provided in the instant specification are extremely specific. The combination of specific components and ranges plays a part in the properties of the compositions that produce the desired data points. Presently, the claimed invention is not commensurate in scope with the compositions disclosed in the instant specification that produce the desired results. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). See MPEP716.02(d). Furthermore, the Applicant should explain the statistical and practical significance to the data provided to determine if a range is critical. Presently it is unclear that the ranges above and below the critical range are different than those within the critical range. It is presently difficult to isolate the impact of each of the ranges deemed to be critical. See also R13-76, R13-79 and R13-81 which fall within scope but have bleeding at an intermediate time point and a number of examples have unmeasured data which makes comparing results more difficult. 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). "[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). As such, the Applicant’s argument is not persuasive and the obviousness rejection stands.
Applicant argues that Midha teaches examples that do not fall within the instantly claimed range for the ratio of water to humectant, and that the ranges of water and humectant taught in Midha are too broad to be considered obvious.
The Examiner does not agree. Midha is used for its teachings of thickeners. However, the range of water to humectant in the instant application falls within the range taught by the prior art of Midha as described by the applicant. Midha is also not limited to the teachings of its 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). 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). With regards to the topic of a critical range of a ratio of water to humectant, the Applicant should explain the statistical and practical significance to the data provided to determine if a range is critical. 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). "[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). Therefore, Midha is not confined to the teachings of its preferred embodiments and it does teach an overlapping range of water and humectants that overlap the ratio of water to humectant disclosed by the instant application in addition to the teachings of Hara. As such, the Applicant’s argument is not persuasive and the obviousness rejection stands.
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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