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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/08/2026 has been entered.
Applicants' arguments, filed 03/09/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 CN202011200316.7 filed 10/30/2020. The instant application is a 371 of PCT/US2021/057285 filed 10/29/2021.
Claim Interpretation
With regards to the term “substantially free” the instant specification recites in paragraph 0087 “In some embodiments, the film is substantially free of titanium containing materials. For example, the film may have about 3 wt.% or less, 2 wt.% or less, 1 wt.% or less, 0.5 wt.% or less, or 0.1 wt.% or less of a titanium containing material, based on the total weight of the film.”. As such, the term “substantially free” is interpreted as “about 3% or less”.
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.
I) Claim 83 is rejected under 35 U.S.C. 103 as being unpatentable over Martinetti (WO2011068513A1) in view of Boyd (US20080260836A1).
Martinetti recites an oral care composition comprising a film entrained in a carrier, wherein the film comprises a nonionic surfactant in an amount from 2% by weight of the film to 20% by weight of the film (Martinetti at claim 1). Martinetti teaches the use of silica from 5% to 70% by weight of the composition (Martinetti at [0065-0066]). Martinetti teaches that the film comprises other active materials including abrasives such as silica (Martinetti at [0052]). Martinetti teaches that the films comprise such active materials at a concentration of 0.01 to 30% by weight of film (Martinetti at [0052]). Martinetti teaches the use of hydroxypropyl methyl cellulose (HPMC), and corn starch (Martinetti at 0030]). Martinetti teaches the use of polymers among those useful herein include polyvinylpyrrolidone, cross-linked polyvinyl pyrrolidone, polyvinylpyrrolidone-vinyl acetate copolymer, polyvinylalcohol, polyacrylic acid, poly acrylate polymer, cross-linked polyacrylate polymer, cross-linked polyacrylic acid (e.g, Carbopol®), polyethylene oxide, polyethylene glycol, poly vinylalkyl ether-maleic acid copolymer (such as Gantrez®) and carboxy vinyl polymer (Martinetti at [0030]). Martinetti teaches the use of natural gums such as sodium alginate, carrageenan, xantham gum, gum acacia, arabic gum, guar gum, pullulan, agar, chitin, chitosan, pectin, karaya gum, zein, hordein, gliadin, locust bean gum, tragacantha (Martinetti at [0030]). Martinetti teaches the use of calcium pyrophosphate and calcium carbonate (Martinetti at [0065]). Martinetti further teaches the use of calcium pyrophosphate as a tartar control agent (Martinetti at [0049]). Martinetti teaches that the film may have a thickness of less than 4 mils or less than 100 microns and from 0.1 mils (2.54 microns) up to 10 mils (254 microns), from 0.5 mils (12.7 microns) up to 5 mils (127 microns), from 1.4 mils (35.6 microns) to 2.0 mils (50.8 microns) (Martinetti at [0039-0043]). Martinetti teaches the use of zinc (Martinetti at [0053-0055]). Martinetti teaches methods for administering a functional material to a human or animal subject in need thereof, comprising topically applying to said subject a composition comprising a film entrained in a carrier, wherein the film includes a relatively high concentration of nonionic surfactants (Martinetti at [0074]).
Martinetti differs from the instant claims in this rejection insofar as it does not teach the braking strength of the film. The teachings of Boyd cure this deficit.
Boyd teaches films are disclosed that comprise a first polymer and a second polymer having a solubility temperature lower than that of the first polymer; wherein the breaking strength of the film is greater than about 750 psi (5,171 kPa) (Boyd at abstract). Boyd recites wherein the breaking strength of the film is about 750 psi (5,171 kPa) to about 5,000 psi (34,470 kPa) (Boyd at claim 2). Boyd recites wherein the first polymer is hydroxypropylmethylcellulose (HPMC) or hydroxypropyl cellulose (HPC) (Boyd at claim 6). Boyd recites wherein the first polymer has a solubility temperature about 105 degrees F. (40.6° C.) to about 170 degrees F. (76.7° C.), and the second polymer has a solubility temperature of about 80 degrees F. (26.7° C.) to about 140 degrees F. (60.0° C.) (Boyd at claim 10). Boyd recites a composition comprising a film in a carrier, wherein the film comprises a first polymer and a second polymer having a lower solubility temperature than the first polymer, and wherein the breaking strength of the film is greater than about 750 psi (5,171 kPa) (Boyd at claim 11). Boyd teaches the use of corn starch and polyethylene glycol (Boyd at [0031]). Boyd teaches the use of menthol (Boyd at [0040]). Boyd teaches the use of calcium pyrophosphate (Boyd at [0069]). Boyd teaches the use of zinc compounds (Boyd at [0039]).
Boyd differs from the instant claim insofar as it does not specifically teach the use of silica in the film. The teachings of Martinetti cures this deficit.
It would have been prima facie obvious to have used the ranges for strength and psi of the oral care film comprising hydroxypropyl methyl cellulose, corn starch, and calcium pyrophosphate taught in Boyd as the ranges for strength and psi of the oral care film comprising hydroxypropyl methyl cellulose, corn starch, and calcium pyrophosphate taught by Martinetti, as Martinetti teaches the film but does not teach the specific psi or durability which is taught by Boyd to be useful in the art of oral care films. See MPEP 2144.07. See MPEP 2143.
Regarding instant claim 83, Martinetti recites an oral care composition comprising a film entrained in a carrier, wherein the film comprises a nonionic surfactant in an amount from 2% by weight of the film to 20% by weight of the film (Martinetti at claim 1). Martinetti teaches that the film comprises other active materials including abrasives such as silica (Martinetti at [0052]). Martinetti teaches that the films comprise such active materials at a concentration of 0.01 to 30% by weight of film (Martinetti at [0052]). Martinetti teaches the use of hydroxypropyl methyl cellulose (HPMC), and corn starch (Martinetti at 0030]). Martinetti teaches a composition comprising about 11.2% to 30.7% hydroxypropyl methyl cellulose (Martinetti at Table 4), about 11.2% to 31.6% (Martinetti at Table 3), and 10.5% to 52.3% (Martinetti at Table 1), which overlaps the instantly claimed range of about 30% to about 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). Martinetti teaches the use of cornstarch in about 3.2% to about 16.1% (Martinetti at Table 1), which overlaps the instantly claimed range of about 5 to about 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). Martinetti teaches a composition comprising about 11.2% to 30.7% hydroxypropyl methyl cellulose (Martinetti at Table 4), about 11.2% to 31.6% (Martinetti at Table 3), and 10.5% to 52.3% (Martinetti at Table 1)and Martinetti teaches the use of cornstarch in about 3.2% to about 16.1% (Martinetti at Table 1) hydroxypropyl methyl cellulose and cornstarch in these ranges can overlap in range with the claimed range of about 2.5:1 to about 5:1. 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). Martinetti teaches the use of calcium pyrophosphate and calcium carbonate (Martinetti at [0065]). Martinetti further teaches the use of calcium pyrophosphate as a tartar control agent (Martinetti at [0049]). Martinetti does not require the use of titanium dioxide. Furthermore, Boyd recites wherein the breaking strength of the film is about 750 psi (5,171 kPa) to about 5,000 psi (34,470 kPa) (Boyd at claim 2), which overlaps with the instantly claimed range of greater than about 750 psi. 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). Boyd recites wherein the first polymer has a solubility temperature about 105 degrees F. (40.6° C.) to about 170 degrees F. (76.7° C.), and the second polymer has a solubility temperature of about 80 degrees F. (26.7° C.) to about 140 degrees F. (60.0° C.) (Boyd at claim 10). Compounds with this solubility would be expected to be undissolved at 40C.
II) Claims 66, 70-71, and 75-85 are rejected under 35 U.S.C. 103 as being unpatentable over Martinetti (WO2011068513A1) and Boyd (US20080260836A1) as applied to claim 83 above, and further in view of Sengupta (US Patent Application Publication 20160136080A1).
The teachings of Martinetti and Boyd are discussed above.
Martinetti and Boyd differ from the instant claims insofar as they do not specifically teach the use of tin oxide. The teachings of Sengupta cure this deficit.
Sengupta teaches personal care compositions and the use of the composition as an additive that has the benefit of stabilizing a product (Sengupta at abstract). Sengupta teaches the use of exfoliating agents including calcium carbonate, silica, and stannic oxide (Sengupta at [00109]). Sengupta teaches that exfoliants can be used in a range of about 0.1% to about 70% (Sengupta at [0052]). Sengupta teaches the use of thickening agents including corn starch and hydroxypropyl methyl cellulose (Sengupta at [0083]). Sengupta does not require the use of titanium dioxide. Sengupta teaches the use of zinc oxides (Sengupta at [0107]). Sengupta does not require the use of titanium coated mica. Sengupta teaches the use of glycerol (Sengupta at [0114]). Sengupta teaches the use of menthol (Sengupta at [0159]).
Sengupta differs from the instant claims insofar as it does not specifically teach the amounts of polymers or gums in the composition. The teachings of Martinetti and Boyd cure this deficit.
It would have been prima facie obvious to have added the additive of Sengupta to the composition of Martinetti and Boyd for the benefit to stability as taught by Sengupta. One would have a reasonable expectation of success because Sengupta teaches that the additive is added to personal care compositions. One would have been motivated to have added the additive of Sengupta to the composition of Martinetti and Boyd for the benefit to stability as taught by Sengupta. It would have been prima facie obvious to have combined the stannic oxide with the silica for its benefit as an exfoliating agent as taught by Sengupta. See MPEP 2144.06(I).
Regarding instant claim 66, Martinetti recites an oral care composition comprising a film entrained in a carrier, wherein the film comprises a nonionic surfactant in an amount from 2% by weight of the film to 20% by weight of the film (Martinetti at claim 1). Martinetti teaches the use of silica from 5% to 70% by weight of the composition (Martinetti at [0065-0066]), which overlaps the instantly claimed range of about0.5% 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). Sengupta teaches the use of exfoliating agents including calcium carbonate, silica, and stannic oxide (Sengupta at [00109]). Sengupta teaches that exfoliants can be used in a range of about 0.1% to about 70% (Sengupta at [0052]). Sengupta teaches the use of thickening agents including corn starch and hydroxypropyl methyl cellulose (Sengupta at [0083]). Martinetti teaches the use of hydroxypropyl methyl cellulose (HPMC), and corn starch (Martinetti at 0030]). Martinetti teaches a composition comprising about 11.2% to 30.7% hydroxypropyl methyl cellulose (Martinetti at Table 4), about 11.2% to 31.6% (Martinetti at Table 3), and 10.5% to 52.3% (Martinetti at Table 1), which overlaps the instantly claimed range of about 30% to about 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). Martinetti teaches the use of cornstarch in about 3.2% to about 16.1% (Martinetti at Table 1), which overlaps the instantly claimed range of about 5 to about 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). Sengupta teaches the use of exfoliating agents including calcium carbonate, silica, and stannic oxide (Sengupta at [00109]). Sengupta teaches that exfoliants can be used in a range of about 0.1% to about 70% (Sengupta at [0052]), which overlaps the instantly claimed range of silica from about 0.5% to about 10% and the instantly claimed range of stannic oxide from about 10% to about 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). One would have been motivated to have added the additive of Sengupta to the composition of Martinetti for the benefit to stability as taught by Sengupta. It would have been prima facie obvious to have combined the stannic oxide with the silica for its benefit as an exfoliating agent as taught by Sengupta. See MPEP 2144.06(I). Martinetti teaches a composition comprising about 11.2% to 30.7% hydroxypropyl methyl cellulose (Martinetti at Table 4), about 11.2% to 31.6% (Martinetti at Table 3), and 10.5% to 52.3% (Martinetti at Table 1) and Martinetti teaches the use of cornstarch in about 3.2% to about 16.1% (Martinetti at Table 1) hydroxypropyl methyl cellulose and cornstarch in these ranges can overlap in range with the claimed range of about 2.2:1 to about 5:1. 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). Martinetti does not require the use of titanium dioxide. Sengupta does not require the use of titanium dioxide. Boyd recites wherein the breaking strength of the film is about 750 psi (5,171 kPa) to about 5,000 psi (34,470 kPa) (Boyd at claim 2), which overlaps with the instantly claimed range of greater than about 750 psi. 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). Boyd recites wherein the first polymer has a solubility temperature about 105 degrees F. (40.6° C.) to about 170 degrees F. (76.7° C.), and the second polymer has a solubility temperature of about 80 degrees F. (26.7° C.) to about 140 degrees F. (60.0° C.) (Boyd at claim 10). Compounds with this solubility would be expected to be undissolved at 40C.
Regarding instant claim 70-71, Martinetti teaches the use of multiple hydroxypropyl methyl celluloses (Martinetti at Tables 1-4).
Regarding instant claim 75, Martinetti teaches the use of zinc (Martinetti at [0053-0055]). Sengupta teaches the use of zinc oxides (Sengupta at [0107]).
Regarding instant claim 76, Martinetti does not require the use of titanium dioxide. Martinetti does not require the use of titanium coated mica. Sengupta does not require the use of titanium dioxide. Sengupta does not require the use of titanium coated mica.
Regarding instant claim 77, Sengupta teaches the use of glycerol (Sengupta at [0114]). Martinetti teaches the use of glycerine (Martinetti at [0064]).
Regarding instant claim 78, Sengupta teaches the use of menthol (Sengupta at [0159]). Martinetti teaches the use of menthol (Martinetti at [0046]). Boyd teaches the use of menthol (Boyd at [0040]).
Regarding instant claim 79, Boyd recites wherein the breaking strength of the film is about 750 psi (5,171 kPa) to about 5,000 psi (34,470 kPa) (Boyd at claim 2), which overlaps with the instantly claimed range of greater than about 1,000 psi. 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 80, Martinetti teaches that the film may have a thickness s of less than 4 mils or less than 100 microns and from 0.1 mils (2.54 microns) up to 10 mils (254 microns), from 0.5 mils (12.7 microns) up to 5 mils (127 microns), from 1.4 mils (35.6 microns) to 2.0 mils (50.8 microns) (Martinetti at [0039-0043]), which overlaps with the instantly claimed range of about 0.01mm to about 0.1mm. 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 81, M Boyd recites wherein the first polymer has a solubility temperature about 105 degrees F. (40.6° C.) to about 170 degrees F. (76.7° C.), and the second polymer has a solubility temperature of about 80 degrees F. (26.7° C.) to about 140 degrees F. (60.0° C.) (Boyd at claim 10). Compounds with this solubility would be expected to be undissolved at 60C.
Regarding instant claim 82, Boyd recites wherein the first polymer has a solubility temperature about 105 degrees F. (40.6° C.) to about 170 degrees F. (76.7° C.), and the second polymer has a solubility temperature of about 80 degrees F. (26.7° C.) to about 140 degrees F. (60.0° C.) (Boyd at claim 10). Compounds with this solubility would be expected to be undissolved at 60C.
Regarding instant claim 83, Martinetti recites an oral care composition comprising a film entrained in a carrier, wherein the film comprises a nonionic surfactant in an amount from 2% by weight of the film to 20% by weight of the film (Martinetti at claim 1). Martinetti teaches the use of silica from 5% to 70% by weight of the composition (Martinetti at [0065-0066]), which overlaps the instantly claimed range of about 0.5% 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). Martinetti teaches the use of hydroxypropyl methyl cellulose (HPMC), and corn starch (Martinetti at 0030]). Martinetti teaches a composition comprising about 11.2% to 30.7% hydroxypropyl methyl cellulose (Martinetti at Table 4), about 11.2% to 31.6% (Martinetti at Table 3), and 10.5% to 52.3% (Martinetti at Table 1), which overlaps the instantly claimed range of about 30% to about 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). Martinetti teaches the use of cornstarch in about 3.2% to about 16.1% (Martinetti at Table 1), which overlaps the instantly claimed range of about 5 to about 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). Martinetti teaches a composition comprising about 11.2% to 30.7% hydroxypropyl methyl cellulose (Martinetti at Table 4), about 11.2% to 31.6% (Martinetti at Table 3), and 10.5% to 52.3% (Martinetti at Table 1)and Martinetti teaches the use of cornstarch in about 3.2% to about 16.1% (Martinetti at Table 1) hydroxypropyl methyl cellulose and cornstarch in these ranges can overlap in range with the claimed range of about 2.5:1 to about 5:1. 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). Martinetti teaches the use of calcium pyrophosphate and calcium carbonate (Martinetti at [0065]). Martinetti further teaches the use of calcium pyrophosphate as a tartar control agent (Martinetti at [0049]). Martinetti does not require the use of titanium dioxide. Boyd recites wherein the breaking strength of the film is about 750 psi (5,171 kPa) to about 5,000 psi (34,470 kPa) (Boyd at claim 2), which overlaps with the instantly claimed range of greater than about 750 psi. 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). Boyd recites wherein the first polymer has a solubility temperature about 105 degrees F. (40.6° C.) to about 170 degrees F. (76.7° C.), and the second polymer has a solubility temperature of about 80 degrees F. (26.7° C.) to about 140 degrees F. (60.0° C.) (Boyd at claim 10). Compounds with this solubility would be expected to be undissolved at 40C.
Regarding instant claim 84, Martinetti recites an oral care composition comprising a film entrained in a carrier, wherein the film comprises a nonionic surfactant in an amount from 2% by weight of the film to 20% by weight of the film (Martinetti at claim 1). Martinetti teaches the use of silica from 5% to 70% by weight of the composition (Martinetti at [0065-0066]), which overlaps the instantly claimed range of about 0.5% 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). Sengupta teaches the use of exfoliating agents including calcium carbonate, silica, and stannic oxide (Sengupta at [00109]). Sengupta teaches that exfoliants can be used in a range of about 0.1% to about 70% (Sengupta at [0052]). Sengupta teaches the use of thickening agents including corn starch and hydroxypropyl methyl cellulose (Sengupta at [0083]). Martinetti teaches the use of hydroxypropyl methyl cellulose (HPMC), and corn starch (Martinetti at 0030]). Martinetti teaches a composition comprising about 11.2% to 30.7% hydroxypropyl methyl cellulose (Martinetti at Table 4), about 11.2% to 31.6% (Martinetti at Table 3), and 10.5% to 52.3% (Martinetti at Table 1), which overlaps the instantly claimed range of about 30% to about 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). Martinetti teaches the use of cornstarch in about 3.2% to about 16.1% (Martinetti at Table 1), which overlaps the instantly claimed range of about 5 to about 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). Sengupta teaches the use of exfoliating agents including calcium carbonate, silica, and stannic oxide (Sengupta at [00109]). Sengupta teaches that exfoliants can be used in a range of about 0.1% to about 70% (Sengupta at [0052]), which overlaps the instantly claimed range of silica from about 0.5% to about 10% and the instantly claimed range of stannic oxide from about 10% to about 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). One would have been motivated to have added the additive of Sengupta to the composition of Martinetti for the benefit to stability as taught by Sengupta. It would have been prima facie obvious to have combined the stannic oxide with the silica for its benefit as an exfoliating agent as taught by Sengupta. See MPEP 2144.06(I). Martinetti teaches a composition comprising about 11.2% to 30.7% hydroxypropyl methyl cellulose (Martinetti at Table 4), about 11.2% to 31.6% (Martinetti at Table 3), and 10.5% to 52.3% (Martinetti at Table 1)and Martinetti teaches the use of cornstarch in about 3.2% to about 16.1% (Martinetti at Table 1) hydroxypropyl methyl cellulose and cornstarch in these ranges can overlap in range with the claimed range of about 2.5:1 to about 5:1. 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). Martinetti does not require the use of titanium dioxide. Sengupta does not require the use of titanium dioxide. Furthermore, Boyd recites wherein the breaking strength of the film is about 750 psi (5,171 kPa) to about 5,000 psi (34,470 kPa) (Boyd at claim 2), which overlaps with the instantly claimed range of greater than about 750 psi. 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). Boyd recites wherein the first polymer has a solubility temperature about 105 degrees F. (40.6° C.) to about 170 degrees F. (76.7° C.), and the second polymer has a solubility temperature of about 80 degrees F. (26.7° C.) to about 140 degrees F. (60.0° C.) (Boyd at claim 10). Compounds with this solubility would be expected to be undissolved at 40C.
Regarding instant claim 85, Martinetti teaches methods for administering a functional material to a human or animal subject in need thereof, comprising topically applying to said subject a composition comprising a film entrained in a carrier, wherein the film includes a relatively high concentration of nonionic surfactants (Martinetti at [0074]).
Response to Arguments
Applicant’s arguments, see remarks, filed 03/09/2026, with respect to the rejection(s) of claims under Martinetti and Sengupta 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 Martinetti, Boyd, and Sengupta.
With regards to the claims in view of Martinetti and Sengupta, Applicant argues that the teachings of Martinetti or Martinetti and Sengupta do not overcome the unexpected results of the instant specification. Therefore, the obviousness rejection should be withdrawn.
The Examiner does not agree. The compositions of the films used in the instant specification data are relatively unknown, the specification recites that the films were prepared having similar compositions (Instant Specification at [00104]). It is difficult to accurately compare compositions when the components of the composition are an unknown variable. "[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). To the best of the Examiners understanding, no statistical significance has been established for the tables presented in the instant specification. The instant specification discusses statistical difference for opacity at paragraph 101 reciting
“Opacity: comometer was used to measure L*a*b* of the film and calculate AW by below formula: W* = ((a*-0)2 + (b*-0)2 + (L*-100)2)1/2; AW= W(film) - W(control). The higher AW score, the better film opacity. Significant difference statistically is considered to define whether the opacity is pass or fail. Neutral means the AW of the sample is lower than control but the appearance in the toothpaste is still good.”
The addition of a “Neutral” opacity makes the statistical significance unclear for opacity. With regards to toughness the Instant Specification recites “Toughness is mainly defined by the process of stretch out the slurry of the films on the platform. If the film is too viscous to be stretched out, then it is failed on toughness. Meanwhile, whether the films can be formed homogeneous after drying is also used to evaluate the toughness. Only the films that is smooth and unbroken can be treated as pass on toughness.” (emphasis added). Which does not denote a psi or a statistical significance. With regards to dissolvability the Instant Specification recites “The films were cut into square strips and then applied in the clear toothpastes at a dosage of 0.12%. Then the toothpastes were placed in oven at 60C for one month to observe the performance of strips. Some of the strips dissolve in the tooth paste after aging with a bad stability in the toothpaste. Whereas some of the strips still stay well in the toothpaste after aging and are mentioned acceptable in the form below.”(emphasis added). Which does not denote statistical significance, nor do the instant claims recite that the material the strip is dissolved in is toothpaste. The Applicant has not established statistical and practical significance with regards to the data in the instant specification. 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(I). Because the components of the compositions in the instant specification are unknown and the practical and statistical significance of the data has not been established, no case of unexpected results has been established. As such, the Applicant’s arguments are not persuasive and the obviousness rejection stands.
Relevant Prior Art
Boyd (WO2005058265A1)
Boyd recites an oral or personal care composition comprising a film entrained in a carrier, wherein said film comprises a functional material (Boyd at claim 1). Boyd recites (Boyd at claim 1). Boyd recites wherein said film comprises a polymer selected from the group consisting of water soluble polymers, water dispersible polymers, and water insoluble polymers, and mixtures thereof (Boyd at claim 2). Boyd recites wherein said polymer is a water soluble polymer (Boyd at claim 3). Boyd recites wherein said water soluble polymer is selected from the group consisting of cellulose ethers, methacrylates, polyvinylpyrollidone, and mixtures thereof (Boyd at claim 4). Boyd recites wherein said polymer comprises a cellulose ether (Boyd at claim 5). Boyd recites wherein said carrier is suitable for use in a oral care composition, hair care composition, skin care composition, or deodorant composition (Boyd at claim 6). Boyd recites wherein said carrier is suitable for use in an oral care composition (Boyd at claim 7). Boyd recites wherein said carrier comprises an active material (Boyd at claim 8). Boyd recites wherein said active material is selected from the group consisting of abrasives, anticaries agents, tartar control agents, antiplaque agents, periodontal actives, breath freshening agents, malodour control agents, whitening agents, and combinations thereof (Boyd at claim 9). Boyd recites herein said active is selected from the group consisting of abrasives, anticaries agents, tartar control agents, antiplaque agents, periodontal actives, breath freshening agents, malodour control agents, whitening agents, stain prevention actives, salivary stimulants, and combinations thereof (Boyd at claim 24). Boyd recites wherein said therapeutic active material is selected from the group consisting of anticaries agents, tartar control agents, antiplaque agents, periodontal actives, breath freshening agents, malodour control agents, whitening agents, antibacterials, vitamins, proteins, conditioning agents, moisturizers, and mixtures thereof (Boyd at claim 26). Boyd recites wherein said film comprises a compatibility enhanced active (Boyd at claim 29). Boyd recites wherein said carrier is suitable for use in a dentifrice, and said active is selected from the group consisting of cationic antimicrobials, calcium salts, fluoride salts, proteins, and mixtures thereof (Boyd at claim 30). Boyd recites wherein said carrier comprises a material selected from the group consisting of glycerin, petrolatum, mineral oil, and mixtures thereof (Boyd at claim 46).
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 Boyd (WO2005058265A1) appears to be just as good as Boyd ‘08. As such, no rejection over Boyd (WO2005058265A1) has been written in view of the provisions of MPEP 904.03.
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 66,70-71, and 75-85 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 61-62,62-66, 68-79 of copending Application No. 18/250,384 in view of Martinetti (WO2011068513A1).
The instant application recites a flexible film for use in an oral care composition, comprising: from about 0.5 to about 10 wt.% of a silica; from about 30 to about 70 wt.% of a polymer comprising hydroxypropyl methyl cellulose; from about 5 to about 30 wt.% of a natural gum comprising corn starch; and from about 10 to about 30 wt.% of a particulate having a refractive index of from about 1.0 to about 2.5, the particulate comprising stannic oxide; and wherein a weight ratio of the polymer to the natural gum is from about 2.2:1 to about 5:1;wherein the film is substantially free of titanium dioxide, and all weight percentages are based on the total weight of the flexible film; and wherein the film has a breaking strength of greater than about 750 psi; and wherein the film remains substantially undissolved after about 2 months at 40°C.
The reference application ‘384 recites a film for use in an oral care composition, comprising: a polymer, a clay, a wax or a combination thereof; a natural gum; and a particulate having a refractive index of from about 1.0 to about 2.5;wherein the film is substantially free of titanium containing materials; and wherein the polymer, clay, wax or the combination thereof comprises hydroxypropyl methyl cellulose, the natural gum comprises starch, the hydroxypropyl methyl cellulose and the starch are at a weight ratio of hydroxypropyl methyl cellulose to starch of about 2.4:1 to about 3:1, and all weight percentages are based on the total weight of the film (‘384 at claim 61). The reference application ‘384 recites from about 30 to about 70 wt.% of the polymer, the clay, the wax or the combination thereof; from about 5 to about 30 wt.% of the natural gum; a particulate having a refractive index of from about 1 to about 2.5, the particulate selected from: stannic oxide; dicalcium phosphate; calcium carbonate; and a combination of two or more thereof; and optionally, an amount of menthol or a derivative thereof; wherein the film is substantially free of titanium dioxide, and all weight percentages are based on the total weight of the oral care film (‘384 at claim 62). The reference application ‘384 recites wherein the hydroxypropyl methyl cellulose comprises a first hydroxypropyl methyl cellulose having a viscosity of 40-60 mpa.s. and a second hydroxypropyl methyl cellulose having a viscosity of 6.5- 8.5 mpa.s (‘384 at claim 65). The reference application ‘384 recites wherein the polymer comprises a vinyl polymer selected from polyvinylpyrrolidone; cross-linked polyvinyl pyrrolidone; polyvinylpyrrolidone-vinyl acetate copolymer; polyvinyl alcohol; a carboxy vinyl polymer; and a combination of two or more thereof (‘384 at claim 66). The reference application ‘384 recites wherein the starch is selected from one or more of maltodextrin; amylose; high amylose starch; corn starch; potato starch; rice starch; tapioca starch; pea starch; sweet potato starch; barley starch; wheat starch; waxy corn starch; and hydroxypropylated high amylose starch (‘384 at claim 68). The reference application ‘384 recites wherein the particulate comprises a zinc compound (‘384 at claim 69). The reference application ‘384 recites wherein the particulate comprises calcium pyrophosphate (‘384 at claim 70). The reference application ‘384 recites wherein the film is free of titanium dioxide and free of titanium coated mica (‘384 at claim 71). The reference application ‘384 recites further comprising a plasticizer selected from: glycerol; a phthalate derivative; propylene glycol; a low molecular weight polyethylene glycol; and a combination of two or more thereof (‘384 at claim 72). The reference application ‘384 recites wherein the film has a breaking strength greater than 750 psi (‘384 at claim 73). The reference application ‘384 recites wherein the film has a thickness of from about 0.01 mm to about 0.1 mm (‘384 at claim 74). The reference application ‘384 recites wherein the film remains substantially undissolved after about 2 months at 40 °C (‘384 at claim 75). The reference application ‘384 recites wherein the film remains substantially undissolved after about 1 month at 60 °C (‘384 at claim 76). The reference application ‘384 recites an oral care film comprising: from about 10 to about 50 wt.% of a polymer, a clay, a wax or a combination thereof; from about 5 to about 30 wt.% of a natural gum, wherein a weight ratio of the polymer, clay, wax or combination thereof to the natural gum is from about 2.2:1 to about 3.2:1; and a particulate having a refractive index of from about 1.0 to about 2.5, the particulate comprising calcium pyrophosphate; and optionally, an amount of menthol or a derivative thereof, wherein the polymer, clay, wax or the combination thereof comprises hydroxypropyl methyl cellulose, the natural gum comprises starch, the hydroxypropyl methyl cellulose and the starch are at a weight ratio of hydroxypropyl methyl cellulose to starch of about 2.4:1 to about 3:1,the film is substantially free of titanium dioxide, and all weight percentages are based on the total weight of the oral care film (‘384 at claim 77). The reference application ‘384 recites an oral care composition comprising: an orally acceptable carrier; and a plurality of films, or film fragments, wherein each film or film fragment comprises: a particulate matter having a refractive index of from about 1.5 to about 2.0;a cellulosic material comprising hydroxypropyl methyl cellulose; and a polysaccharide; wherein the cellulosic material and the polysaccharide are present in a weight ratio of from about 2.4:1 to about 3:1; and wherein the film is substantially free of a titanium containing material (‘384 at claim 78). The reference application ‘384 recites wherein the particulate material comprises calcium pyrophosphate (‘384 at claim 79).
The reference application differs from the instant application insofar as it does not teach the use of silica in the flexible film. The teachings of Martinetti cure this deficit.
The teachings of Martinetti are discussed in the obviousness rejections above.
It would have been prima facie obvious to one of ordinary skill in the art to have add the silica of Martinetti to the film of the reference application ‘384 for the benefit as an oral care abrasive as taught by Marinetti. See MPEP 2144(II). See MPEP 2144.07.
This is a provisional nonstatutory double patenting rejection.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
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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