DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application claims domestic priority to PRO 63/293,345 filed 12/23/2021 and PRO 63/293,355 filed 12/23/2021. The instant application is a CON of 18/088,448.
Information Disclosure Statement
The information disclosure statements (IDS) dated 01/13/2025, 04/24/2025, 07/14/2025, and 04/06/2026 all comply with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Claim Objections
Claim 16 is objected to because of the following informalities: punctuation is missing after the table. Appropriate correction is required. The Examiner recommends the addition of a period after the table of claim 16.
Claim Interpretation
The Examiner is interpreting for all broad range or limitation together with a narrow range or limitation that are presently indefinite that the broad range or limitation is range that will be examined in the present action until such a time that the indefiniteness rejection is withdrawn.
The Examiner is interpreting the term “for a sufficient period of time” of claim 18 to be any positive amount of time contacting the teeth until such a time that the indefiniteness rejection is withdrawn.
Examiner Note Regarding Prior Art
The instant claims require a polyoxyethylene/polyoxypropylene polymer having the following formula
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41
358
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Wherein a is an integer between 1 and 30, and b is an integer between 10 and 60. The examiner takes the position that the polymer known as Pluronic L35 would have meet this criteria. In support of this position, the examiner cites International Journal of Toxicology, Vol. 27(Suppl 2), 2008, pages 93-128, as of page 94, left and right columns, relevant figure and table reproduced below with annotation by the examiner.
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232
675
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792
693
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As such, the skilled artisan would have expected that a prior art teaching of Pluronic L-35 would have read on the required polyoxyethylene/polyoxypropylene triblock copolymer of claim 1 wherein a=11 and b=16.
The examiner clarifies that the above-cited reference is not part of the statement of rejection as it is not drawn to a tooth whitening composition; in contrast, it is cited to better explain the meaning of terms used in the cited prior art.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation calcium pyrophosphate and insoluble sodium metaphosphate, and the claim also recites (Ca2P2O7) and ([NaPO3]n) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation calcium pyrophosphate, and the claim also recites (Ca2P2O7) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation polyphosphates and surfactants, and the claim also recites (e.g., alkali metal polyphosphates) and (e.g., anionic and/or zwitterionic surfactants) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 6, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites the broad recitation antioxidant, and the claim also recites e.g., selected from butylated hydroxyanisole, butylated hydroxytoluene, vitamin A, carotenoids, vitamin E, flavonoids,polyphenols, ascorbic acid, and mixtures thereof which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 10, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation wherein an integer between 10 and 12, and b is an integer between 15 and 20, and the claim also recites (e.g., 11) (e.g., 16), e.g., the polymer is Pluronic L35 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 11, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 11 contains the trademark/trade name Pluronic L35. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a polyoxyethylene/polyoxypropylene triblock copolymer and, accordingly, the identification/description is indefinite.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation wherein an integer between 10 and 12, and b is an integer between 15 and 20, and the claim also recites (e.g., 11) (e.g., 16), e.g., the polymer is Pluronic L35 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 12, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 12 contains the trademark/trade name Pluronic L35. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a polyoxyethylene/polyoxypropylene triblock copolymer and, accordingly, the identification/description is indefinite.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation PEG/PPG random copolymer having an average molar ratio of ethylene glycol units (EG) to propylene glycol units (PG) of about 105-125 EG to 55-75 PG, and the claim also recites (e.g., Pluracare L1220 polymer) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 13, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 13 contains the trademark/trade name Pluracare L1220 polymer. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a PEG/PPG random copolymer and, accordingly, the identification/description is indefinite.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 15 recites the broad recitation a blue dye or pigment, , optionally in an amount of 0.001 to 0.1% by weight of the composition, and the claim also recites e.g., Blue 15 pigment (also known as CI 74160) and e.g.,0.01 to 0.08%, or 0.03 to 0.07%, or about 0.05%, by weight of the composition which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 14, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation of components before parenthesis and amounts before parenthesis, and the claim also recites narrower components within parenthesis and narrower amounts within parenthesis which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 16, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 16 contains the trademark/trade name Pluronic L35. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a polyoxyethylene/polyoxypropylene triblock copolymer and, accordingly, the identification/description is indefinite.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 17 recites the broad recitation a dentifrice, and the claim also recites e.g. a toothpaste or tooth gel which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 17, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 18 recites the broad recitation for a sufficient period of time, and the claim also recites (e.g., 0.1 to 60 minutes, or 0.1 to 30 minutes, or 0.1 to 10 minutes, or 0.1 to 5 minutes, or 0.1 to 2 minutes, or 0.1 to 1 minute) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 18, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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. Claims 1-12, 14-15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Strand et al (US Patent Application Publication 20140377194 A1 provided by applicant in the IDS filed 01/13/2025) in view of Yuan (US Patent Application Publication 20200206123A1 provided by applicant in the IDS filed 01/13/2025).
Strand teaches the use of potassium peroxymonosulfate in a range of from about 0.1% to about 10% (Strand at [0083-0084]), calcium pyrophosphate in a range from about 6% to about 70% (Strand at [0107]), and teaches the use of poloxamers and block polymers including Pluronics (Strand at [0120], [0106]). Strand teaches the use of surfactants ([0102-0106]). Strand teaches the use of sodium lauryl sulfate and cocamidopropyl betaine (Strand at [0104]). Strand teaches the use of vitamins (Strand of [0087]). Strand teaches that the composition is a dentifrice (Strand whole document). Strand teaches that the composition is applied to teeth (Strand of [0125-0135]) for a period of time.
The teachings of Strand differ from the instant invention insofar as they do not teach the use of Pluronic ® L35. The teachings of Yuan cure this deficit.
Yuan teaches an oral care composition comprising calcium pyrophosphate (Yaun at [0076]), Pluronic ® L35 (Yuan at [0059]), PEG -600 (Yuan at claim 9), sodium metaphosphates (Yuan at [0076]), sodium lauryl sulfate (Yuan at [0060]), cocamidopropyl betaine (Yuan at [0062]), vitamin A (Yuan at [0069]), polyvinylpyrrolidone (Yuan at [0064]), and blue dye (Yuan at [0074]). Yuan teaches the use of Pluronic ® L35 in an amount from 0.01% to about 99% by weight of the composition (Yuan at [0029-0037]). Yuan teaches the use of surfactants in an amount from about 0.01% to about 20% by weight of the composition (Yuan at [0058-0063]), and further teaches the use of sodium lauryl sulfate (Yuan at [0059]), and cocamidopropyl betaine (Yuan at [0062]).
The teachings of Yuan differ from the instant claims insofar as they do not specifically disclose potassium peroxymonosulfate. The teachings of Strand cure this deficit.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Strand et al. disclose wherein the oral care composition comprises poloxamers and Pluronic’s, but does not disclose Pluronic ® L35. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the Pluronic of Strand et al. to include Pluronic ® L35 since that size is a known and effective size for Pluronic used in oral care compositions as taught by Yuan.
Regarding instant claim 1, Strand teaches the use of potassium peroxymonosulfate in a range of from about 0.1% to about 10% (Strand at [0083-0084]), which overlaps the instantly claimed range of 0.01% to 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). Strand teaches the use of calcium pyrophosphate in a range from about 6% to about 70% (Strand at [0107]), which overlaps the instantly claimed range of 21 -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). Strand teaches the use of poloxamers and block polymers including Pluronics and more specifically poloxamer 407 (Strand at [0120], [0106]). Yuan teaches the use of Pluronic ® L35 in an amount from 0.01% to about 99% by weight of the composition (Yuan at [0029-0037]), which overlaps the instantly claimed range of 20%-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.
Regarding instant claim 2, one would have been motivated to use only one peroxide to reduce the number of components within the composition, which would reduce cost and be desired by consumers.
Regarding instant claim 3, Strand teaches the use of calcium pyrophosphate in a range from about 6% to about 70% (Strand at [0107]), which overlaps with the instantly claimed range of 21% 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).
Regarding instant claim 4, Strand teaches the use of calcium pyrophosphate in a range from about 6% to about 70% (Strand at [0107]), which overlaps with the instantly claimed range of 22% 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).
Regarding instant claim 5, Strand teaches the use of poloxamers and block polymers including Pluronic’s and more specifically poloxamer 407 (Strand at [0120], [0106]). Yuan teaches the use of Pluronic ® L35 (Yuan at [0029-0037]).
Regarding instant claim 6, Strand teaches the use of surfactants ([0102-0106]).
Regarding instant claim 7, Strand teaches the use of sodium lauryl sulfate and cocamidopropyl betaine (Strand at [0104]).
Regarding instant claim 8, Strand teaches the use of sodium lauryl sulfate and cocamidopropyl betaine (Strand at [0104]).
Regarding instant claim 9, Strand teaches the use of sodium lauryl sulfate of cocamidopropyl betaine and teaches the use of surfactants in a range of about 0.025% to about 9% and further (Strand at [0104]), which overlaps the instantly claimed range of 2% to 4% for sodium lauryl sulfate and 0.1% to 1% for cocamidopropyl betaine. It would have been prima facie obvious to have optimized the type and amount of surfactant in the composition to have produced the desired mouth feeling and foaming for the toothpaste. See MPEP 2144.05(II)(A). Yuan teaches the use of surfactants in an amount from about 0.01% to about 20% by weight of the composition (Yuan at [0058-0063]), and further teaches the use of sodium lauryl sulfate (Yuan at [0059]), and cocamidopropyl betaine (Yuan at [0062]). This overlaps the instantly claimed range of 2% to 4% for sodium lauryl sulfate and 0.1% to 1% for cocamidopropyl betaine. 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, Strand teaches the use of vitamins (Strand of [0087]). Yuan teaches the use of BHA, BHT, vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid, herbal antioxidants, chlorophyll, melatonin, or the like, or mixtures or combinations thereof (Yuan at [0069]).
Regarding instant claim 11, Strand teaches the use of potassium peroxymonosulfate in a range of from about 0.1% to about 10% (Strand at [0083-0084]), which overlaps the instantly claimed range of 1% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Strand teaches the use of calcium pyrophosphate in a range from about 6% to about 70% (Strand at [0107]), which overlaps the instantly claimed range of 20-40%. 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). Strand teaches the use of poloxamers and block polymers including Pluronics and more specifically poloxamer 407 (Strand at [0120], [0106]). Yuan teaches the use of Pluronic ® L35 in an amount from 0.01% to about 99% by weight of the composition (Yuan at [0029-0037]), which overlaps the instantly claimed range of 25%-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.
Regarding instant claim 12, Strand teaches the use of potassium peroxymonosulfate in a range of from about 0.1% to about 10% (Strand at [0083-0084]), which overlaps the instantly claimed range of 1% 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). Strand teaches the use of calcium pyrophosphate in a range from about 6% to about 70% (Strand at [0107]), which overlaps the instantly claimed range of 20-30%. 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). Strand teaches the use of poloxamers and block polymers including Pluronics and more specifically poloxamer 407 (Strand at [0120], [0106]). Yuan teaches the use of Pluronic ® L35 in an amount from 0.01% to about 99% by weight of the composition (Yuan at [0029-0037]), which overlaps the instantly claimed range of 25%-35%. 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 MPEP2144.05(I).
Regarding instant claim 14, Strand teaches the use of tetrasodium pyrophosphate and disodium dihydrogen pyrophosphate, which is another name for disodium pyrophosphate, in an amount from about 1% to about 15% (Strand at [0080-0082]), which overlaps the instantly claimed range of 2%-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 MPEP2144.05(I).
Regarding instant claim 15, Strand teaches the use of colorant but does not describe a color (Strand at [0137]). Yuan teaches the use of blue dye or pigment (Yuan at [0074]).
Regarding instant claim 17, Strand teaches that the composition is a dentifrice (Strand whole document).
Regarding instant claim 18, Strand teaches that the composition is applied to teeth (Strand of [0125-0135]) for a period of time. Yuan teaches a method of use that is applying or contacting the oral care composition with the surfaces of the teeth at predetermined intervals, for example, on a daily basis, every other day, once or twice a week, or once a month (Yuan at [0084]).
II. Claims 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Strand et al (US Patent Application Publication 20140377194 A1 provided by applicant in the IDS filed 01/13/2025) and Yuan (US Patent Application Publication 20200206123A1 provided by applicant in the IDS filed 01/13/2025) as applied to claims 1-12, 14-15, and 17-18 above, and further in view of Fei et al. (US 20170143599 A1).
The teachings of Strand and Yuan are discussed above.
The combined teachings of Strand and Yuan differ from instant claim 13 insofar as they do not specifically teach an amount of polyvinyl pyrrolidone in the composition. The teaching of Fei cure this deficit.
Fei teaches an oral care composition having a whitening agent; a first abrasive selected from calcium pyrophosphate, calcium carbonate, and dicalcium phosphate; a second abrasive that may include sodium metaphosphate; an anticalculus agent; and a substantially anhydrous carrier that may include an ethylene oxide/propylene oxide copolymer (Fei at abstract). Fei teaches the use of carriers at about 49% (Fei at Table 2) and about 60% (Fei at Table 1), Fei further teaches that carrier may include copolymers including Pluracare ® L1220 and PEG-600. Fei further teaches that calcium pyrophosphate and sodium metaphosphate stabilize peroxymonosulfate (Fei at Example 2).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Strand and Yuan et al. disclose wherein the oral care composition comprises polyvinylpyrrolidone, but does not disclose an amount. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the polyvinylpyrrolidone of Strand et al. and Yuan to be in an amount of about 2% since that amount is a known and effective amount for polyvinyl pyrrolidone used in oral care compositions as taught by Fei.
Regarding instant claim 13, Strand teaches the use of polyethylene glycol in a range of 5% to 55% by weight of the composition which overlaps the instantly claimed range of 5% 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. Fei teaches that the polyethylene glycol can be PEG-600 (Fei at [0065]), and Yuan further teaches the use of PEG-600 (Yuan at [0036-0037]). Fei teaches the use of polyvinylpyrrolidone at 2% (Fei at Table 3), which overlaps the instantly claimed range of 1% to 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. Yuan further teaches the use of polyvinylpyrrolidone as a structure-building agent that is capable of interacting with the carrier and dispersants (Yuan at [0065-0066]). Fei teaches the use of Pluracare ® L1220 and further teaches the use of polyethylene glycol/polypropylene glycol 116/66 at 7.5 % by weight of the composition (Fei at Table 1) and 10% by weight of the composition (Fei at Table 3), which overlaps the instantly claimed range of 6% to 15%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Yuan teaches the use of PEG/PG 116/66 in an amount from 0.01% to about 99% by weight of the composition (Yuan at [0029-0037]), which overlaps the instantly claimed range of 6%-15%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Regarding instant claim 16, Strand teaches the use of potassium peroxymonosulfate in a range of from about 0.1% to about 10% (Strand at [0083-0084]), which overlaps the instantly claimed range of 0.1% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Strand teaches the use of calcium pyrophosphate in a range from about 6% to about 70% (Strand at [0107]), which overlaps the instantly claimed range of 20-30%. 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).
Strand teaches the use of poloxamers and block polymers including Pluronics and more specifically poloxamer 407 (Strand at [0120], [0106]). Yuan teaches the use of Pluronic ® L35 in an amount from 0.01% to about 99% by weight of the composition (Yuan at [0029-0037]), which overlaps the instantly claimed range of 25%-35%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Fei teaches the use of polyvinylpyrrolidone at 2% (Fei at Table 3), which overlaps the instantly claimed range of 1% to 15%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Yuan further teaches the use of polyvinylpyrrolidone as a structure-building agent that is capable of interacting with the carrier and dispersants (Yuan at [0065-0066]).
Fei teaches the use of Pluracare ® L1220 and further teaches the use of polyethylene glycol/polypropylene glycol 116/66 at 7.5 % by weight of the composition (Fei at Table 1) and 10% by weight of the composition (Fei at Table 3), which overlaps the instantly claimed range of 6% to 15%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Yuan teaches the use of PEG/PG 116/66 in an amount from 0.01% to about 99% by weight of the composition (Yuan at [0029-0037]), which overlaps the instantly claimed range of 6%-15%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Strand teaches the use of polyethylene glycol in a range of 5% to 55% by weight of the composition which overlaps the instantly claimed range of 10% 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. Fei teaches that the polyethylene glycol can be PEG-600 (Fei at [0065]), and Yuan further teaches the use of PEG-600 (Yuan at [0036-0037]).
Strand teaches tetrasodium pyrophosphate (a polyphosphate, see instant specification at page 16) in an amount from about 1% to about 15% (Strand at [0080-0082]), which overlaps with the instantly claimed range 2.5% -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.
Strand teaches the use of sodium lauryl sulfate of cocamidopropyl betaine and teaches the use of surfactants in a range of about 0.025% to about 9% and further (Strand at [0104]), which overlaps the instantly claimed range of 1% to 5% for sodium lauryl sulfate and 0.1% to 1% for cocamidopropyl betaine. It would have been prima facie obvious to have optimized the charge and amount of surfactant in the composition to have produced the desired mouth feeling and foaming for the toothpaste. See MPEP 2144.05(II)(A). Yuan teaches the use of surfactants in an amount from about 0.01% to about 20% by weight of the composition (Yuan at [0058-0063]), and further teaches the use of sodium lauryl sulfate (Yuan at [0059]), and cocamidopropyl betaine (Yuan at [0062]). This overlaps the instantly claimed range of 1% to 5% for anionic surfactants or sodium lauryl sulfate and 0.1% to 1% for zwitterionic surfactants or cocamidopropyl betaine. 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).
Strand teaches the use of fluoride (Strand at [0066-0069]), and further teaches examples using 0.24% sodium fluoride (Strand at Table 1), which overlaps the instantly claimed range of 0.1% to 2%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Fei teaches stannous fluoride in amount ranging from 0.1% to 3% (Fei at [0070]), which overlaps the instantly claimed range of 0.1% to 2%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Yuan teaches the use of stannous fluoride in a range between 0.1% and 10% (Yuan at [0080]), which overlaps the instantly claimed range of 0.1% to 2%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Strand teaches the use of vitamins (Strand at [0087]). Fei teaches the use of butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid, herbal antioxidants, chlorophyll, melatonin, and mixtures thereof (Fei at [00712]). Yuan teaches the use of BHA, BHT, vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid, herbal antioxidants, chlorophyll, melatonin, or the like, or mixtures or combinations thereof in a range of 0.0001% to 1% (Yuan at [0069]), which overlaps the instantly claimed range of 0 to 0.3%. 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).
Strand teaches thickeners in an amount from 0.1% to 15% (Strand at [0115]), which overlaps the instantly claimed range of 2.5% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Fei teaches thickeners in an amount from 0.1% to 90% (Fei at [0064]), which overlaps the instantly claimed range of 2.5% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Yuan teaches thickeners in an amount from 0.1% to 30% (Yuan at [0068]), which overlaps the instantly claimed range of 2.5% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Strand teaches the use of 0.1% to 10% of sweeteners (Strand at [0111]), which overlaps the instantly claimed range of 0.5% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Fei teaches the use of 2.25 of flavor (Fei at Table 1), which overlaps the instantly claimed range of 0.5% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Yuan teaches the use of 0.005% to 5% of sweeteners (Yuan at [0072]), which overlaps the instantly claimed range of 0.5% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Strand teaches the use of colorant but does not describe a color (Strand at [0137]). Fei teaches the use of colorants but does not describe a color (Fei at [0067]). Yuan teaches the use of blue dye or pigment (Yuan at [0074]).Strand teaches the use of the use of colorant in an amount of 0.4, and further specifies the use of titanium dioxide in a range of 0.25% to 5%. It would have been obvious to have combined the titanium dioxide with the blue pigment of Yuan to produce a blue toothpaste. It would have been obvious to have optimized the amount of titanium dioxide and blue pigment to produce the desired color shade and saturation. See MPEP 2144.05(II). One would have a reasonable expectation of success because both titanium dioxide and blue pigment are used as colorants in oral care compositions.
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.
A) Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,299,998. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent requires an anticalculus agent that is not required by the independent claim of the instant application. The instant application recites a tooth whitening oral care composition comprising 0.01-10% potassium peroxymonosulfate by weight, stabilized with a combination of 21-60% calcium pyrophosphate (Ca2P207) and/or insoluble sodium metaphosphate ([NaPO3]n), by weight of the composition, and 20-60% polyoxyethylene/polyoxypropylene triblock copolymer,by weight of the composition (Instant claim 1).
The reference patent recites single phase oral care composition, comprising: a whitening agent; a first abrasive comprising sodium metaphosphate; a second abrasive; an anticalculus agent; and a substantially anhydrous carrier comprising an ethylene oxide/propylene oxide copolymer, wherein a wt % of the second abrasive is equal to or greater than wt % of the first abrasive and wherein the whitening agent is potassium persulfate (potassium peroxymonosulfate) (‘998 at claim 1). The reference patent recites wherein the second abrasive is not calcium pyrophosphate (‘998 at claim 2). The reference patent recites wherein the anticalculus agent comprises an agent selected from: a polyphosphate; a hexametaphosphate salt; a polyolefin sulfonate; and a combination of two or more thereof (998 at claim 3). The reference patent recites wherein the carrier has a total water content of less than about 4%, by weight (998 at claim 4). The reference patent recites wherein the composition is a dentifrice (998 at claim 5). The reference patent recites wherein the composition further comprises sodium lauryl sulfate and a fluoride source (998 at claim 6). The reference patent recites single phase oral care composition, comprising: a whitening agent; a first abrasive comprising sodium metaphosphate; fumed silica; an anticalculus agent; and a substantially anhydrous carrier comprising an ethylene oxide/propylene oxide copolymer, wherein a wt % of the fumed silica is less than wt % of the first abrasive and wherein the whitening agent is potassium persulfate (potassium peroxymonosulfate) (‘998 at claim 7). The reference patent recites wherein the anticalculus agent comprises an agent selected from: a polyphosphate; a hexametaphosphate salt; a polyolefin sulfonate; and a combination of two or more thereof (998 at claim 8). The reference patent recites wherein the carrier has a total water content of less than about 4%, by weight (‘998 at claim 9). The reference patent recites wherein the composition is a dentifrice (998 at claim 10). The reference patent recites wherein the composition further comprises sodium lauryl sulfate and a fluoride source (998 at claim 11).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
B) Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,161,739 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent is specific to tobacco stains which the instant application is not. The instant application recites a tooth whitening oral care composition comprising 0.01-10% potassium peroxymonosulfate by weight, stabilized with a combination of 21-60% calcium pyrophosphate (Ca2P207) and/or insoluble sodium metaphosphate ([NaPO3]n), by weight of the composition, and 20-60% polyoxyethylene/polyoxypropylene triblock copolymer,by weight of the composition (Instant claim 1).
The reference patent recites a solid oral care composition for the removal or diminution of tenacious tooth stains, wherein the tenacious stains are tobacco stains, comprising a tooth whitening effective amount of an alkali metal salt of peroxymonosulfate and 70 to 95% by weight of an abrasive, wherein the salt of peroxymonosulfate is potassium peroxymonosulfate and wherein the tooth whitening effective amount of the peroxymonosulfate salt is 2% to 8%, by weight of the composition, and wherein the composition does not comprise any other peroxide compound whitening agent in addition to the peroxymonosulfate salt, and wherein the composition is a toothpowder (‘739 at claim 1). The reference patent recites wherein the potassium peroxymonosulfate is a triple salt of potassium peroxymonosulfate, potassium hydrogen sulfate and potassium sulfate, optionally wherein the triple salt comprises about 47%-50% by weight of potassium peroxymonosulfate (739 at claim 2). The reference patent recites wherein the composition comprises an effective amount of peroxymonosulfate salt which is 2% to 4% by weight of the composition (739 at claim 3). The reference patent recites wherein the effective amount of peroxymonosulfate salt is about 5% by weight of the composition (739 at claim 4). The reference patent recites wherein the abrasive is selected from calcium carbonate, sodium carbonate, sodium chloride, sodium bicarbonate, silica, arginine bicarbonate, calcium phosphate, calcium pyrophosphate, dicalcium phosphate, zinc oxide, calcined alumina, and combinations thereof (‘739 at claim 5). The reference patent recites wherein the abrasive is calcium carbonate (‘739 at claim 6). The reference patent recites method of bleaching the teeth to remove or diminish tenacious stains, wherein the tenacious stains are tobacco stains, comprising the steps of (1) mixing a solid oral care composition, which composition is a toothpowder and which comprises a tooth whitening effective amount of an alkali metal salt of peroxymonosulfate and 70 to 95% of an abrasive by weight of the toothpowder composition, into (a) water to form a solution or suspension, (b) a mouthrinse base to form a solution or suspension, or (c) a toothpaste base to form a suspension or paste, followed by (2) applying the resulting solution, suspension, or paste to the teeth; wherein the salt of peroxymonosulfate is potassium peroxymonosulfate and wherein the tooth whitening effective amount of the peroxymonosulfate salt is 2% to 8%, by weight of the toothpowder composition, and wherein the toothpowder composition does not comprise any other peroxide compound whitening agent in addition to the peroxymonosulfate salt (‘739 at claim 7). The reference patent recites wherein the toothpowder composition comprises an effective amount of peroxymonosulfate salt which is 2% to 4% by weight of the toothpowder composition (739 at claim 8). The reference patent recites wherein the toothpowder composition comprises an effective amount of peroxymonosulfate salt which is about 5% by weight of the toothpowder composition (739 at claim 9). The reference patent recites wherein the abrasive comprises calcium carbonate (‘739 at claim 10). The reference patent recites wherein the peroxymonosulfate salt is potassium peroxymonosulfate in an amount of 2% to 4% by weight of the toothpowder composition, and wherein the abrasive comprises calcium carbonate (‘739 at claim 11). The reference patent recites wherein the toothpowder composition consists of the potassium peroxymonosulfate, the abrasive, and optionally one or more of drying agents, lubricants, disintegrating agents, buffering agents, binders, flavor agents, fluoride sources, surfactants, preservatives, and color agents (‘739 at claim 12). The reference patent recites wherein the toothpowder composition consists of the potassium peroxymonosulfate, the abrasive, a fluoride source, and a surfactant (‘739 at claim 13). The reference patent recites wherein the toothpowder composition consists of 2 to 8% potassium peroxymonosulfate, and 70-95% calcium carbonate abrasive, each by weight of the toothpowder composition, and optionally a fluoride source, a surfactant, or both (‘739 at claim 14). The reference patent recites wherein the toothpowder composition is mixed with the water or mouthrinse base, until the toothpowder composition dissolves, and the resulting solution is applied to the teeth (739 at claim 15). The reference patent recites wherein the toothpowder composition is mixed with the water or mouthrinse base to form a suspension, and the resulting suspension is applied to the teeth (739 at claim 16). The reference patent recites wherein the toothpowder composition is mixed with a toothpaste base to form a suspension or paste, and the resulting suspension or paste is applied to the teeth (739 at claim 17).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
C) Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,166,890 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent is specific to tobacco stains which the instant application is not. The instant application recites a tooth whitening oral care composition comprising 0.01-10% potassium peroxymonosulfate by weight, stabilized with a combination of 21-60% calcium pyrophosphate (Ca2P207) and/or insoluble sodium metaphosphate ([NaPO3]n), by weight of the composition, and 20-60% polyoxyethylene/polyoxypropylene triblock copolymer,by weight of the composition (Instant claim 1).
The reference patent recites solid oral care composition for the removal or diminution of tenacious tooth stains, wherein the tenacious stains are tobacco stains, comprising a tooth whitening effective amount of an alkali metal salt of peroxymonosulfate and 70 to 95% by weight of an abrasive, wherein the salt of peroxymonosulfate is potassium peroxymonosulfate and wherein the tooth whitening effective amount of the peroxymonosulfate salt is 2% to 8%, by weight of the composition, and wherein the composition does not comprise any other peroxide compound whitening agent in addition to the peroxymonosulfate salt, and wherein the composition is a toothpowder (‘439 at claim 1). The reference patent recites wherein the potassium peroxymonosulfate is a triple salt of potassium peroxymonosulfate, potassium hydrogen sulfate and potassium sulfate, optionally wherein the triple salt comprises about 47%-50% by weight of potassium peroxymonosulfate (439 at claim 2). The reference patent recites wherein the composition comprises an effective amount of peroxymonosulfate salt which is 2% to 4% by weight of the composition (439 at claim 3). The reference patent recites wherein the effective amount of peroxymonosulfate salt is about 5% by weight of the composition (439 at claim 4). The reference patent recites wherein the abrasive is selected from calcium carbonate, sodium carbonate, sodium chloride, sodium bicarbonate, silica, arginine bicarbonate, calcium phosphate, calcium pyrophosphate, dicalcium phosphate, zinc oxide, calcined alumina, and combinations thereof (‘439 at claim 5). The reference patent recites wherein the abrasive is calcium carbonate (‘439 at claim 6). The reference patent recites method of bleaching the teeth to remove or diminish tenacious stains, wherein the tenacious stains are tobacco stains, comprising the steps of (1) mixing a solid oral care composition, which composition is a toothpowder and which comprises a tooth whitening effective amount of an alkali metal salt of peroxymonosulfate and 70 to 95% of an abrasive by weight of the toothpowder composition, into (a) water to form a solution or suspension, (b) a mouthrinse base to form a solution or suspension, or (c) a toothpaste base to form a suspension or paste, followed by (2) applying the resulting solution, suspension, or paste to the teeth; wherein the salt of peroxymonosulfate is potassium peroxymonosulfate and wherein the tooth whitening effective amount of the peroxymonosulfate salt is 2% to 8%, by weight of the toothpowder composition, and wherein the toothpowder composition does not comprise any other peroxide compound whitening agent in addition to the peroxymonosulfate salt (‘439 at claim 7). The reference patent recites wherein the toothpowder composition comprises an effective amount of peroxymonosulfate salt which is 2% to 4% by weight of the toothpowder composition (439 at claim 8). The reference patent recites wherein the toothpowder composition comprises an effective amount of peroxymonosulfate salt which is about 5% by weight of the toothpowder composition (439 at claim 9). The reference patent recites wherein the abrasive comprises calcium carbonate (‘439 at claim 10). The reference patent recites wherein the peroxymonosulfate salt is potassium peroxymonosulfate in an amount of 2% to 4% by weight of the toothpowder composition, and wherein the abrasive comprises calcium carbonate (‘439 at claim 11). The reference patent recites wherein the toothpowder composition consists of the potassium peroxymonosulfate, the abrasive, and optionally one or more of drying agents, lubricants, disintegrating agents, buffering agents, binders, flavor agents, fluoride sources, surfactants, preservatives, and color agents (‘439 at claim 12). The reference patent recites wherein the toothpowder composition consists of the potassium peroxymonosulfate, the abrasive, a fluoride source, and a surfactant (‘439 at claim 13). The reference patent recites wherein the toothpowder composition consists of 2 to 8% potassium peroxymonosulfate, and 70-95% calcium carbonate abrasive, each by weight of the toothpowder composition, and optionally a fluoride source, a surfactant, or both (‘439 at claim 14). The reference patent recites wherein the toothpowder composition is mixed with the water or mouthrinse base, until the toothpowder composition dissolves, and the resulting solution is applied to the teeth (‘439 at claim 15). The reference patent recites wherein the toothpowder composition is mixed with the water or mouthrinse base to form a suspension, and the resulting suspension is applied to the teeth (‘439 at claim 16). The reference patent recites wherein the toothpowder composition is mixed with a toothpaste base to form a suspension or paste, and the resulting suspension or paste is applied to the teeth (439 at claim 17).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
D) Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,805,788 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent requires the use of a flavor system which is not required by the independent claim of the instant application. The instant application recites a tooth whitening oral care composition comprising 0.01-10% potassium peroxymonosulfate by weight, stabilized with a combination of 21-60% calcium pyrophosphate (Ca2P207) and/or insoluble sodium metaphosphate ([NaPO3]n), by weight of the composition, and 20-60% polyoxyethylene/polyoxypropylene triblock copolymer,by weight of the composition (Instant claim 1).
The reference patent recites a low-water oral care composition comprising: (a) a flavor system, wherein the flavor system comprises a carrier matrix for encapsulating one or more flavor ingredient(s), and wherein the carrier matrix comprises a protective coating layer that encapsulates the flavor ingredient(s), and wherein the protective coating layer comprises maltodextrin, and an emulsifier; and (b) potassium peroxymonosulfate; and wherein the low-water oral care composition comprises less than 4% water by weight of the total composition (‘788 at claim 1). The reference patent recites wherein the emulsifier is soya lecithin (788 at claim 2). The reference patent recites wherein the composition is anhydrous (788 at claim 3). The reference patent recites wherein the flavor system is present from 0.05% to 5% by weight, relative to the total weight of the composition (788 at claim 4). The reference patent recites wherein the protective layer further comprises a carbohydrate material selected from the group consisting of: corn syrup, a chemically modified starch, a hydrogenated starch hydrolysate, succinylated starch, hydrolyzed starch, and combinations thereof (788 at claim 5). The reference patent recites wherein the carrier matrix further comprises one or more sugars selected from the group consisting of: sucrose, glucose, lactose, fructose, sorbitol, isomalt, ribose, levulose, mannitol, lactitol, xylitol, dextrose, maltitol, xylose, galactose, pentatol, pentose, arabinose and combinations thereof (‘788 at claim 6). The reference patent recites wherein the protective layer of the carrier matrix consists of agar, maltodextrin, an emulsifier, and optionally sucrose (788 at claim 7). The reference patent recites wherein the maltodextrin is present from 70% to 85% by weight relative the dry weight of the carrier matrix, wherein the emulsifier is present from 0.25 to 2% by weight relative to the dry weight of the carrier matrix, and wherein the agar is present from 0.25% to 2% by weight relative to the dry weight of the carrier matrix (‘788 at claim 8). The reference patent recites wherein the protective layer comprises maltodextrin, agar, an emulsifier, and sucrose, wherein the maltodextrin is present from 35% to 50% by weight relative the dry weight of the carrier matrix, wherein the emulsifier is present from 0.25 to 2% by weight relative to the dry weight of the carrier matrix, wherein the sucrose is present from 35% to 50% by weight relative the dry weight of the carrier matrix, and wherein the agar is present from 0.25% to 2% by weight relative to the dry weight of the carrier matrix (‘788 at claim 9). The reference patent recites wherein the protective coating layer further comprises qum arabica (788 at claim 10). The reference patent recites wherein the flavor system comprises one or more non-encapsulated liquid flavor ingredients and a carrier matrix that encapsulates one or more additional flavor ingredient(s) (788 at claim 11). The reference patent recites wherein the composition further comprises hydrogen peroxide (788 at claim 12). The reference patent recites wherein the composition further comprises a polyoxyethylene/polyoxypropylene triblock copolymer, and wherein the triblock copolymer has the formula:
HO—[CH2CH2O]a[—CH(CH3)CH2O—]b[CH2CH2O]a—H,
wherein a is an integer between 1 and 30, b is an integer between 10 and 60 (788 at claim 13). The reference patent recites wherein the composition further comprises one or more of polyvinylpyrrolidone, polyethylene glycol/polypropylene glycol random copolymer, polyethylene glycol, polyphosphates, and surfactants (788 at claim 14). The reference patent recites wherein the composition further comprises a mixture of anionic and zwitterionic surfactants (788 at claim 15). The reference patent recites wherein the composition comprises 2 to 4% of sodium lauryl sulfate, and 0.1 to 1% of cocamidopropyl betaine, by weight of the composition (788 at claim 16). The reference patent recites wherein the composition comprises or consists of potassium peroxymonosulfate from 0.1-5%, calcium pyrophosphate from 21-30%, 1-5% sodium lauryl sulfate, 0.1-1% cocamidopropyl betaine, and a flavor system comprising a carrier matrix, wherein the carrier matrix comprises a protective coating layer comprising maltodextrin, agar, and an emulsifier, which encapsulates one or more flavor ingredient(s) within the carrier matrix; and wherein the composition comprises less than 1% water by weight of the total composition (‘788 at claim 17). The reference patent recites wherein the composition comprises or consists of 25-35% of poloxamer 407, 0.1-5% potassium peroxymonosulfate, and 0.5-5% of a flavor system, wherein the flavor system comprises a carrier matrix and wherein the carrier matrix comprises a protective coating layer encapsulating one or more flavor ingredients, and wherein the protective coating layer comprises maltodextrin, agar, and an emulsifier; and wherein the carrier matrix is provided in an amount effective so that the hydrophilic groups present on the poloxamer 407 do not prematurely dissolve the maltodextrin despite the presence of maltodextrin's alcohol groups (‘788 at claim 18). The reference patent recites a method for whitening teeth comprising the steps of (a) applying a composition according to claim 1, to the teeth, and (b) maintaining contact of the composition with the teeth for a sufficient period of time to effect whitening of the teeth contacted by the composition (788 at claim 19). The reference patent recites wherein the emulsifier is soya lecithin (788 at claim 20).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
E) Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,075,797 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent requires the use of a flavor system which is not required by the independent claim of the instant application. The instant application recites a tooth whitening oral care composition comprising 0.01-10% potassium peroxymonosulfate by weight, stabilized with a combination of 21-60% calcium pyrophosphate (Ca2P207) and/or insoluble sodium metaphosphate ([NaPO3]n), by weight of the composition, and 20-60% polyoxyethylene/polyoxypropylene triblock copolymer,by weight of the composition (Instant claim 1).
The reference patent recites low-water oral care composition comprising: (a) a flavor system, wherein the flavor system comprises a carrier matrix for encapsulating one or more flavor ingredient(s), and wherein the carrier matrix comprises a protective coating layer that encapsulates the flavor ingredient(s), and wherein the protective coating layer comprises gum arabica, agar, and an emulsifier; and (b) potassium peroxymonosulfate; and wherein the low-water oral care composition comprises less than 4% water by weight of the total composition (‘797 at claim 1). The reference patent recites wherein the emulsifier is soya lecithin (797 at claim 2). The reference patent recites wherein the composition is anhydrous (797 at claim 3). The reference patent recites wherein the flavor system is present from 0.05% to 5% by weight, relative to the total weight of the composition (797 at claim 4). The reference patent recites wherein the protective layer further comprises a carbohydrate material selected from the group consisting of: maltodextrin, corn syrup, a chemically modified starch, a hydrogenated starch hydrolysate, succinylated starch, hydrolyzed starch and combinations thereof (797 at claim 5). The reference patent recites wherein the carrier matrix further comprises one or more sugars selected from the group consisting of: sucrose, glucose, lactose, fructose, sorbitol, isomalt, ribose, levulose, mannitol, lactitol, xylitol, dextrose, maltitol, xylose, galactose, pentatol, pentose, arabinose, and combinations thereof (‘797 at claim 6). The reference patent recites wherein the protective layer of the carrier matrix consists of agar, gum arabica, an emulsifier, and optionally sucrose (797 at claim 7). The reference patent recites wherein the gum arabica is present from 70% to 85% by weight relative the dry weight of the carrier matrix, wherein the emulsifier is present from 0.25 to 2% by weight relative to the dry weight of the carrier matrix, and wherein the agar is present from 0.25% to 2% by weight relative to the dry weight of the carrier matrix (‘797 at claim 8). The reference patent recites wherein the protective layer comprises gum arabica, agar, an emulsifier, and sucrose, wherein the gum arabica is present from 35% to 50% by weight relative the dry weight of the carrier matrix, wherein the emulsifier is present from 0.25 to 2% by weight relative to the dry weight of the carrier matrix, wherein the sucrose is present from 35% to 50% by weight relative the dry weight of the carrier matrix, and wherein the agar is present from 0.25% to 2% by weight relative to the dry weight of the carrier matrix (‘797 at claim 9). The reference patent recites wherein the flavor system comprises one or more non-encapsulated liquid flavor ingredients and a carrier matrix that encapsulates one or more additional flavor ingredient(s)(‘797 at claim 10). The reference patent recites wherein the whitening agent further comprises hydrogen peroxide (‘797 at claim 11). The reference patent recites wherein the composition further comprises a polyoxyethylene/polyoxypropylene triblock copolymer, and wherein the triblock copolymer has the formula:
HO—[CH2CH2O]a[—CH(CH3)CH2O—]b[CH2CH2O]a—H,
wherein a is an integer between 1 and 30, b is an integer between 10 and 60 (797 at claim 12). The reference patent recites wherein the composition further comprises one or more of polyvinylpyrrolidone, polyethylene glycol/polypropylene glycol random copolymer, polyethylene glycol, polyphosphates, and surfactants (‘797 at claim 13). The reference patent recites wherein the composition further comprises a mixture of anionic and zwitterionic surfactants (797 at claim 14). The reference patent recites wherein the composition comprises 2 to 4% of sodium lauryl sulfate, and 0.1 to 1% of cocamidopropyl betaine, by weight of the composition (797 at claim 15). The reference patent recites wherein the composition comprises or consists of potassium peroxymonosulfate from 0.1-5%, calcium pyrophosphate from 21-30% sodium lauryl sulfate from 1-5%, cocamidopropyl betaine from 0.1-1%, and a flavor system comprising a carrier matrix, wherein the carrier matrix comprises a protective coating layer comprising gum arabica, agar, and an emulsifier, which encapsulates one or more flavor ingredient(s) within the carrier matrix; and wherein the composition comprises less than 4% 1% water by weight of the total composition (‘797 at claim 16). The reference patent recites wherein the composition comprises or consists of 25-35% poloxamer 407, 0.1-5% potassium peroxymonosulfate, and 0.5-5% of a flavor system, wherein the flavor system comprises a carrier matrix and wherein the carrier matrix comprises a protective coating layer encapsulating one or more flavor ingredients, and wherein the protective coating layer comprises gum arabica, agar, and an emulsifier; and wherein the carrier matrix is provided in an amount effective so that the hydrophilic groups present on the poloxamer 407 do not prematurely dissolve the gum arabica despite the presence of gum arabica's alcohol groups (‘797 at claim 17). The reference patent recites a method for whitening teeth comprising the steps of (a) applying a composition according to claim 1, to the teeth, and (b) maintaining contact of the composition with the teeth for a sufficient period of time to effect whitening of the teeth contacted by the composition (797 at claim 18). The reference patent recites wherein the emulsifier is soya lecithin (797 at claim 19).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
F) Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,582,585 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent requires when mixed with water at a 1:3 weight ratio and stirred at 4000 rpm for 120 seconds, produces a foam having an average bubble size (R32) of not more than 50 μm which is not required by the independent claim of the instant application. The instant application recites a tooth whitening oral care composition comprising 0.01-10% potassium peroxymonosulfate by weight, stabilized with a combination of 21-60% calcium pyrophosphate (Ca2P207) and/or insoluble sodium metaphosphate ([NaPO3]n), by weight of the composition, and 20-60% polyoxyethylene/polyoxypropylene triblock copolymer,by weight of the composition (Instant claim 1).
The reference patent recites tooth whitening oral care composition comprising potassium peroxymonosulfate, calcium pyrophosphate (Ca2P2O7) and/or insoluble sodium metaphosphate ([NaPO3]n), a surfactant system comprising the combination of an anionic surfactant and a zwitterionic surfactant, wherein the weight ratio of the anionic and the zwitterionic surfactants is about 20:1 to about 1:1, wherein the zwitterionic surfactant is a betaine surfactant, wherein the composition contains less than 4% water by weight, and wherein the composition, when mixed with water at a 1:3 weight ratio and stirred at 4000 rpm for 120 seconds, produces a foam having an average bubble size (R32) of not more than 50 μm (‘585 at claim 1). The reference patent recites wherein the composition comprises the potassium peroxymonosulfate in an amount of 0.01% to 10% by weight of the composition wherein the potassium peroxymonosulfate is the only oxidizing agent present in the composition (585 at claim 2). The reference patent recites wherein the potassium peroxymonosulfate is the only oxidizing agent present in the composition (585 at claim 3). The reference patent recites wherein the composition is stabilized by calcium pyrophosphate (Ca2P2O7) (585 at claim 4). The reference patent recites wherein the composition comprises the calcium pyrophosphate in an amount of 5 to 50% by weight of the composition (585 at claim 5). The reference patent recites wherein the zwitterionic surfactant is cocamidopropyl betaine (585 at claim 6). The reference patent recites wherein the anionic surfactant is sodium lauryl sulfate (585 at claim 7). The reference patent recites wherein the composition comprises 2 to 4%, or 1 to 3%, or 2 to 3%, or 1.5 to 2.5%, or 2 to 2.5%, or about 2%, of sodium lauryl sulfate, and 0.1 to 1%, or 0.1 to 0.5%, or about 0.3%, of cocamidopropyl betaine, by weight of the composition (585 at claim 8). The reference patent recites wherein the composition further comprises a polyoxyethylene/polyoxypropylene triblock copolymer (585 at claim 9). The reference patent recites wherein the polyoxyethylene/polyoxypropylene triblock copolymer is a triblock copolymer having the formula
HO—[CH2CH2O]a[—CH(CH3)CH2O—]b[CH2CH2O]a—H,
wherein a is an integer between 1 and 30, b is an integer between 10 and 60 (585 at claim 10). The reference patent recites wherein the composition further comprises one or more of polyvinylpyrrolidone, polyethylene glycol/polypropylene glycol random copolymer, polyethylene glycol, alkali metal polyphosphates, and surfactants (‘585 at claim 11). The reference patent recites wherein the composition further comprises an antioxidant selected from the group consisting of butylated hydroxyanisole, butylated hydroxytoluene, vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid, and mixtures thereof (‘585 at claim 12). The reference patent recites wherein the composition comprises the potassium peroxymonosulfate in an amount of 1% to 5%, and the composition is stabilized by a combination of 20-40% calcium pyrophosphate and 25-50% of a polyoxyethylene/polyoxypropylene triblock copolymer having the formula HO—[CH2CH2O]a[—CH(CH3)CH2O—]b[CH2CH2O]a—H, wherein an integer between 10 and 12, and b is an integer between 15 and 20, each by weight of the composition (‘585 at claim 13). The reference patent recites wherein the composition comprises the potassium peroxymonosulfate in an amount of 1% to 3%, and the composition is stabilized by a combination of 20-30% calcium pyrophosphate and 25-35% of a polyoxyethylene/polyoxypropylene triblock copolymer having the formula HO—[CH2CH2O]a[—CH(CH3)CH2O—]b[CH2CH2O]a—H, wherein a is an integer between 10 and 12, and b is an integer between 15 and 20 (‘585 at claim 14). The reference patent recites wherein the composition further comprises polyvinylpyrrolidone in an amount of 1 to 10%, and PEG/PPG random copolymer having an average molar ratio of ethylene glycol units (EG) to propylene glycol units (PG) of about 105-125 EG to 55-75 PG in an amount of 6 to 15%, and polyethylene glycol 600 in an amount of 5 to 20%, each by weight of the composition (‘585 at claim 15). The reference patent recites wherein the composition further comprises 2% to 5% tetrasodium pyrophosphate and 0.5 to 1.5% disodium pyrophosphate, by weight of the composition (585 at claim 16). The reference patent recites wherein the composition further comprises a blue dye or pigment, in an amount of 0.001 to 0.1% by weight of the composition (585 at claim 17). The reference patent recites wherein the composition comprises: Potassium peroxymonosulfate (0.1-5% by weight of the composition); Calcium pyrophosphate (20-30% by weight of the composition); PEG/PPG triblock copolymer (25-35% by weight of the composition); Polyvinylpyrrolidone (1-15% by weight of the composition); PEG-PPG random copolymer (6-15% by weight of the composition); Polyethylene glycol (10-20% by weight of the composition); Polyphosphate (2.5-5% by weight of the composition); Anionic Surfactant (1-5% by weight of the composition); Zwitterionic Surfactant (0.1-1% by weight of the composition); Fluoride source (0.1 to 2% by weight of the composition); Antioxidant (0 to 0.3% by weight of the composition); Thickener (2.5-5% by weight of the composition); Sweeteners and Flavors (0.5-5% by weight of the composition); Blue pigment or dye (0.001 to 0.1% by weight of the composition) (‘585 at claim 18). The reference patent recites wherein the composition is a dentifrice, wherein the dentifrice is a toothpaste or tooth gel (585 at claim 19). The reference patent recites a method for whitening teeth comprising the steps of (a) applying a composition according to claim 1, to the teeth, and (b) maintaining contact of the composition with the teeth for a sufficient period of time, comprising 0.1 to 60 minutes, or 0.1 to 30 minutes, or 0.1 to 10 minutes, or 0.1 to 5 minutes, or 0.1 to 2 minutes, or 0.1 to 1 minute, to effect whitening of the teeth contacted by the composition (‘585 at claim 20).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
G) Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,226,499 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent recites that composition does not comprise hydrogen peroxide which is not required by the independent claim of the instant application. The instant application recites a tooth whitening oral care composition comprising 0.01-10% potassium peroxymonosulfate by weight, stabilized with a combination of 21-60% calcium pyrophosphate (Ca2P207) and/or insoluble sodium metaphosphate ([NaPO3]n), by weight of the composition, and 20-60% polyoxyethylene/polyoxypropylene triblock copolymer,by weight of the composition (Instant claim 1).
The reference patent recites a tooth whitening oral care composition comprising 1% to 5% potassium peroxymonosulfate by weight, stabilized with a combination of 22% to 30% calcium pyrophosphate (Ca2P2O7), by weight of the composition, and 25-35% polyoxyethylene/polyoxypropylene triblock copolymer having the formula
HO—[CH2CH2O]a[—CH(CH3)CH2O—]b[CH2CH2O]a—H,
wherein a is an integer between 10 and 12, b is an integer between 15 and 20, by weight of the composition; and further comprising: 6-15% of a PEG/PPG random copolymer, by weight of the composition; 10 to 15% of a polyethylene glycol, by weight of the composition; and polyvinylpyrrolidone in an amount of 1 to 15%, by weight of the composition; wherein the composition is a toothpaste or tooth gel, and wherein the composition does not comprise hydrogen peroxide (499 at claim 1). The reference patent recites wherein the potassium peroxymonosulfate is the only oxidizing agent present in the composition (499 at claim 2). The reference patent recites wherein the composition is stabilized by 23% to 27% calcium pyrophosphate (Ca2P2O7), by weight of the composition (499 at claim 3). The reference patent recites wherein the composition comprises the calcium pyrophosphate in an amount of 24% to 26%, or about 25%, by weight of the composition (499 at claim 4). The reference patent recites wherein the composition further comprises one or more of alkali metal polyphosphates, and anionic and/or zwitterionic surfactants (499 at claim 5). The reference patent recites wherein the composition comprises a mixture of anionic and zwitterionic surfactants (499 at claim 6). The reference patent recites wherein the composition comprises a mixture of sodium lauryl sulfate and cocamidopropyl betaine (499 at claim 7). The reference patent recites wherein the composition comprises 2 to 4%, or 1 to 3%, or 2 to 3%, or 1.5 to 2.5%, or 2 to 2.5%, or about 2%, of sodium lauryl sulfate, and 0.1 to 1%, or 0.1 to 0.5%, or about 0.3%, of cocamidopropyl betaine, by weight of the composition (‘499 at claim 8). The reference patent recites wherein the composition further comprises an antioxidant selected from butylated hydroxyanisole, butylated hydroxytoluene, vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid, and mixtures thereof (‘499 at claim 9). The reference patent recites wherein the polyethylene glycol is selected from the group consisting of PEG-200, PEG-300, PEG-400, PEG-500, PEG-600, PEG-800, PEG-1000, PEG-1600, and PEG-2000 (499 at claim 10). The reference patent recites wherein the composition comprises the potassium peroxymonosulfate in an amount of 1% to 3%, by weight of the composition (499 at claim 11). The reference patent recites wherein the PEG/PPG random copolymer has an average molar ratio of ethylene glycol units (EG) to propylene glycol units (PG) of about 105-125 EG to 55-75 PG and wherein the polyethylene glycol is polyethylene glycol 600 in an amount of 10 to 15%, each by weight of the composition (499 at claim 12). The reference patent recites wherein the composition further comprises 2% to 5% tetrasodium pyrophosphate and 0.5 to 1.5% disodium pyrophosphate, by weight of the composition (499 at claim 13). The reference patent recites wherein the composition further comprises a blue dye or pigment, optionally in an amount of 0.001 to 0.1% by weight of the composition (499 at claim 14). The reference patent recites wherein the composition comprises: Ingredient Weight % Potassium peroxymonosulfate 1% Calcium pyrophosphate 25% PEG/PPG triblock copolymer 30-32% Polyvinylpyrrolidone 5% PEG-PPG random copolymer 10% Polyethylene glycol 12.5% sodium pyrophosphates 2.5-5% sodium lauryl sulfate 1-5% cocamidopropyl betaine 0.1-1% sodium monofluorophosphate 0.1 to 2% Antioxidant 0 to 0.3% fumed silica 2.5-5% Sweeteners and Flavors 0.5-5% Blue pigment or dye 0.001 to 0.1% Total ca. 100 (‘499 at claim 15). The reference patent recites method for whitening teeth comprising the steps of (a) applying a composition according to claim 1, to the teeth, and (b) maintaining contact of the composition with the teeth for a sufficient period of time to effect whitening of the teeth contacted by the composition (499 at claim 16). The reference patent recites wherein the PEG/PPG triblock copolymer has the formula HO—[CH2CH2O]a[—CH(CH3)CH2O—]b[CH2CH2O]a—H, wherein a is an integer between 10 and 12, and b is an integer between 15 and 20, wherein the PEG-PPG random copolymer is PEG/PPG 116/66, the polyethylene glycol is PEG-600, and the sodium pyrophosphates are tetrasodium and/or disodium pyrophosphates (‘499 at claim 17). The reference patent recites wherein the composition has a viscosity (measured at 1 rpm) of 150,000 to 250,000 cP, or 175,000 to 225,000 cP, or about 200,000 cP, and/or wherein the composition has a squeeze pressure of 0.03 to 0.07 bar, or 0.04 to 0.06 bar, or about 0.05 bar (499 at claim 18). The reference patent recites wherein after up to 3 months of aging at 40° C./65% relative humidity, the composition retains a squeeze pressure below 0.1 bar and/or a viscosity (at 1 rpm) below 300,000 cP (499 at claim 19). The reference patent recites wherein the composition loses not more than 10% of its initial active oxygen (AO) content after up to 3 months of aging at 60° C./75% relative humidity (499 at claim 20).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
H) Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,214,063. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent requires a hydratable adhesive film which is not required by the independent claim of the instant application. The instant application recites a tooth whitening oral care composition comprising 0.01-10% potassium peroxymonosulfate by weight, stabilized with a combination of 21-60% calcium pyrophosphate (Ca2P207) and/or insoluble sodium metaphosphate ([NaPO3]n), by weight of the composition, and 20-60% polyoxyethylene/polyoxypropylene triblock copolymer,by weight of the composition (Instant claim 1).
The reference patent recites a tooth whitening strip comprising: a hydratable adhesive film consisting of: from about 60 to about 90%, by weight, of water-soluble or water-swellable polymers, the water-soluble or water-swellable polymers consisting of a polyvinylpyrrolidone polymer and a polyethylene glycol polymer; from about 0.1 to about 10%, by weight, of an inorganic salt of peroxymonosulfate, the inorganic salt of peroxymonosulfate being dispersed in the hydratable adhesive film; water; and a buffering agent, wherein all weight percentages are based on the total weight of the strip (‘063 at claim 1). The reference patent recites wherein the inorganic salt of peroxymonosulfate is sodium peroxymonosulfate, potassium peroxymonosulfate, or ammonium peroxymonosulfate (063 at claim 2). The reference patent recites wherein the inorganic salt of peroxymonosulfate is potassium peroxymonosulfate (063 at claim 3). The reference patent recites wherein the potassium peroxymonosulfate is provided as a triple salt of potassium peroxymonosulfate, potassium hydrogen sulfate and potassium sulfate (063 at claim 4). The reference patent recites wherein the strip comprises an effective amount of peroxymonosulfate salt which is 0.1 to 5%, by weight of the composition (063 at claim 5). The reference patent recites wherein the strip does not comprise hydrogen peroxide (063 at claim 6). The reference patent recites wherein the inorganic salt of peroxymonosulfate is the only oxidizing agent present in the strip (063 at claim 7). The reference patent recites wherein the hydratable adhesive film comprises about 70 to about 90%, by weight, of the one or more polymers (063 at claim 8). The reference patent recites a method for whitening teeth comprising the steps of (a) wetting the strip according to claim 1, with water or saliva or assisting, (b) removing any protective backing from the strip, and (c) affixing the adhesive surface of the strip to the teeth for a sufficient period of time to effect whitening of the teeth contacted by the wetted film (‘063 at claim 9). The reference patent recites wherein the triple salt of potassium peroxymonosulfate comprises about 45 about 50%, by weight, of the amount of potassium peroxymonosulfate (063 at claim 10). The reference patent recites tooth whitening strip consisting of: a hydratable adhesive film consisting of: one or more polyvinylpyrrolidone polymer, a polyethylene glycol, an inorganic salt of peroxymonosulfate dispersed in the hydrated adhesive film, a buffering agent, and water; an inert paper or plastic backing affixed to the hydratable adhesive film; and a removable inert paper or plastic backing removably affixed to the hydratable adhesive film (‘063 at claim 11).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
a) Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 and 21 of copending Application No. 18/354,302 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application requires a hydratable adhesive film which is not required by the independent claim of the instant application. The instant application recites a tooth whitening oral care composition comprising 0.01-10% potassium peroxymonosulfate by weight, stabilized with a combination of 21-60% calcium pyrophosphate (Ca2P207) and/or insoluble sodium metaphosphate ([NaPO3]n), by weight of the composition, and 20-60% polyoxyethylene/polyoxypropylene triblock copolymer,by weight of the composition (Instant claim 1).
The reference application recites an intermediate composition (e.g., an aqueous slurry) for the formulation of a tooth whitening strip comprising a hydratable adhesive film, wherein the intermediate composition comprises an inorganic salt of peroxymonosulfate (‘302 at claim 1). The reference application recites wherein the salt of peroxymonosulfate is potassium peroxymonosulfate (‘302 at claim 2). The reference application recites wherein the potassium peroxymonosulfate is provided as a triple salt of potassium peroxymonosulfate, potassium hydrogen sulfate and potassium sulfate, optionally wherein the triple salt comprises about 45%-50% by weight of potassium peroxymonosulfate, e.g., 47% or 49% by weight of potassium peroxymonosulfate (‘302 at claim 3). The reference application recites wherein the composition comprises an effective amount of peroxymonosulfate salt which is 0.01 % to 5%, by weight of the composition (‘302 at claim 4). The reference application recites wherein the inorganic salt of peroxymonosulfate is the only oxidizing agent present in the composition (‘302 at claim 5). The reference application recites wherein the composition comprises one or more water-soluble or water-swellable polymers, including anionic polymers and/or neutral polymers (‘302 at claim 6). The reference application recites wherein the composition comprises one or more humectants selected from: polyethylene glycols (such as PEG-200, PEG-300, PEG-400, PEG-500, PEG-600, PEG-800, PEG-1000, PEG-1600, PEG-2000), polypropylene glycols, polyoxyethylene-polyoxypropylene copolymers (PEG- PPG, including block copolymers, triblock copolymers (poloxamers, such as poloxamer 407), and random copolymers, such as PEG/PPG-116/66 and PEG/PPG-38/8), ethanol,glycerin, propylene glycol, sorbitol, and xylitol (‘302 at claim 7). The reference application recites wherein the composition comprises one or more humectants selected from polyethylene glycols, PEG-PPG copolymers, and glycerin (‘302 at claim 8). The reference application recites wherein the composition comprises at least one polyethylene glycol, e.g., selected from PEG-200, PEG-300, PEG-400, PEG- 500, PEG-600, PEG-800, PEG-1000, PEG-1600, and PEG-2000 (‘302 at claim 9). The reference application recites wherein the composition comprises PEG-600 (‘302 at claim 10). The reference application recites wherein the composition further comprises one or more polymer selected from polysaccharides (e.g., cellulose derivatives, for example carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose, microcrystalline cellulose; or polysaccharide gums, for example xanthan gum, guar gum, or carrageenan gum, pectins, karaya gum); chitosans; dextrans; polyvinyl pyrrolidone (PVP), such as cross- linked PVP; hyaluronic acid and sodium hyaluronates; synthetic anionic polymeric polycarboxylates, such as copolymers of maleic anhydride or acid with another polymerizable ethylenically unsaturated monomer, preferably methyl vinyl ether (e.g., copolymers in a 1:4 to 4:1 ratio of maleic anhydride/acid to methyl vinyl ether); polyphosphonic acids and polyphosphonates; cross-linked carboxyvinyl copolymers; polyacrylic acid or polyacrylate polymers; polyacrylamides, such as (2- hydroxypropyl)methacrylamide; polyamines; polyvinyl alcohols; polyvinyl pyrrolidine - polyvinyl acetate copolymers (PVP-VA); polyoxazolines, such as poly(2-alkyl-2- oxazolines), isopropyl substituted polyoxazolines; and quaternary ammonium polymers (‘302 at claim 11). The reference application recites wherein the composition comprises one or more polyvinylpyrrolidone (PVP) polymers, e.g., linear and/or cross-linked PVP polymers (‘302 at claim 12). The reference application recites wherein the composition consists of water, PVP, potassium peroxymonosulfate triple salt (e.g., Caroat®), and one or more of polyethylene glycol (e.g., PEG-600), PEG-PPG copolymer (e.g., Poloxamer 105), and glycerin (‘302 at claim 13). The reference application recites wherein the composition is an aqueous slurry (‘302 at claim 15). The reference application recites tooth whitening strip comprising a hydratable adhesive film, wherein the strip comprises or is prepared from an intermediate composition according to claim 1 (‘302 at claim 16). The reference application recites wherein the strip further comprises an inert paper or plastic backing layer to which the hydratable adhesive film is adhered or affixed, and/or an inert removable paper or plastic protective film adhered to the hydratable adhesive film, optionally, wherein the protective film and/or the backing strip are comprised of wax paper, coated paper, treated paper, polyethylene, polystyrene, polypropylene, polyvinyl chloride, polyvinyl acetate, polymethyl methacrylate, polytetrafluoroethylene, polyesters (e.g., polyethylene terephthalate), polyimides, polycarbonates, or any combination thereof (‘302 at claim 18). The reference application recites a method for producing a tooth whitening strip comprising the steps of (a) applying the composition of claim 1, to a backing layer, and (b) drying the composition to the backing layer to form the hydratable adhesive layer of the strip (e.g., by removing water and other volatile ingredients) (‘302 at claim 19). The reference application recites wherein the method comprises applying a strip according to claim 17 to one or more teeth (‘302 at claim 21).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
b) Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/463,723 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application recites the use of hydrogen peroxide which is not required by the independent claim of the instant application. The instant application recites a tooth whitening oral care composition comprising 0.01-10% potassium peroxymonosulfate by weight, stabilized with a combination of 21-60% calcium pyrophosphate (Ca2P207) and/or insoluble sodium metaphosphate ([NaPO3]n), by weight of the composition, and 20-60% polyoxyethylene/polyoxypropylene triblock copolymer,by weight of the composition (Instant claim 1).
The reference application recites tooth whitening oral care composition comprising (a) 0.01-10% potassium peroxymonosulfate by weight of the composition, 5%-60% of an abrasive selected from calcium pyrophosphate (Ca2P207), insoluble sodium metaphosphate ([NaPO3]n), wherein n represents any integer from 1 to 2000, anhydrous dicalcium phosphate (CaHPO4), or mixtures thereof, by weight of the composition, and (c) from 0.25-25% of a source of hydrogen peroxide, by weight of the composition, wherein the source of hydrogen peroxide provides hydrogen peroxide in an amount from 0.05%-4.5% by wt. of the total composition wherein the oral care composition exhibits a stability such that an active oxygen content of the composition is greater than at least about 70% of an initial active oxygen content after 13 weeks of aging at 40°C (‘723 at claim 1). The reference application recites wherein the composition comprises the potassium peroxymonosulfate in an amount of 0.01% to 5%, or 0.05% to 5%, or 0.1% to 5%, or 0.5% to 3%, or 0.5% to 2.5%, or 0.5% to 2%, or 0.5% to 1.5%, or 0.75% to 1.25%, or 1% to 5%, or 1% to 4%, or 1% to 3% or 1% to 2%, or 1.5% to 3%, or 2% to 3%, or 1.5% to 2%, or 2% to 2.5%, or about 0.5%, or about 1%, or about 1.5%, or about 2%, or about 2.5%, by weight of the composition (‘723 at claim 2). The reference application recites wherein the potassium peroxymonosulfate and the source of hydrogen peroxide are the only oxidizing agents present in the composition and/or the only whitening agents present in the composition (723 at claim 3). The reference application recites wherein the composition comprises 5-60% calcium pyrophosphate (Ca2P207) by weight of the composition (723 at claim 4). The reference application recites wherein the source of hydrogen peroxide is selected from polymer-linked hydrogen peroxide complex, silica-hydrogen peroxide complex and liquid aqueous hydrogen peroxide (723 at claim 5). The reference application recites wherein the source of hydrogen peroxide is cross- linked polyvinylpyrrolidone-hydrogen peroxide complex (‘723 at claim 6). The reference application recites wherein the composition comprises a polyoxyethylene/polyoxypropylene triblock copolymer, and wherein the triblock copolymer has the formula HO-[CH2CH2O]a[-CH(CH3)CH2O-]b[CH2CH2O]a-H,wherein a is an integer between 1 and 30, b is an integer between 10 and 60 (‘723 at claim 7). The reference application recites wherein the composition further comprises one or more of polyvinylpyrrolidone, polyethylene glycol, humectants, polyphosphates, surfactants, and thickening agents (‘723 at claim 8). The reference application recites wherein the composition comprises sodium lauryl sulfate and/or cocamidopropyl betaine (‘723 at claim 9). The reference application recites wherein the composition comprises 2 to 4%, or 1 to 3%, or 2 to 3%, or 1.5 to 2.5%, or 2 to 2.5%, or about 2%, of sodium lauryl sulfate,and/or 0.1 to 1%, or 0.1 to 0.5%, or about 0.3%, of cocamidopropyl betaine, by weight of the composition (‘723 at claim 10). The reference application recites wherein the composition further comprises a polyethylene glycol/polypropylene glycol random copolymer (PEG/PPGcopolymer, such as PEG/PPG 116/66 or PEG/PPG 38/8), for example, in an amount of 0.5% to 50%, by weight of the composition (‘723 at claim 11). The reference application recites wherein the composition further comprises a humectant, optionally wherein the humectant comprises propylene glycol in an amount of 1 to 20% by weight of the composition (723 at claim 12). The reference application recites wherein the composition further comprises one or more thickening agents, e.g., selected from the group consisting of sodium stearate, magnesium aluminum silicate, or fumed silica, optionally in an amount of 0.1% to 10% by weight of the composition (723 at claim 13). The reference application recites wherein the composition comprises cross-linked polyvinylpyrrolidone and fumed silica, or sodium stearate and fumed silica (‘723 at claim 14). The reference application recites wherein the composition comprises or consists of: (A) potassium peroxymonosulfate ,cross-linked PVP-hydrogen peroxide complex, calcium pyrophosphate, PEG/PPG triblock copolymer , polyvinylpyrrolidone, PEG-PPG random copolymer , polyethylene glycol, polyphosphates, anionic surfactant, zwitterionic surfactant, a fluoride source, a thickener, selected from the group consisting of fumed silicaser sodium stearate and a combination thereiof, and one or more sweeteners, flavors, and or colors, and optionally propylene glycol, and optionally an antioxidant; or (B) potassium peroxymonosulfate, cross-linked PVP-hydrogen peroxide complex, calcium pyrophosphate, PEG/PPG triblock copolymer, polyvinylpyrrolidone, PEG-PPG random copolymer, polyethylene glycol, polyphosphates, anionic surfactant, a fluoride source, a thickener, and one or more sweeteners, flavors, and or colors, and optionally propylene glycol, and optionally an antioxidant; or (C) potassium peroxymonosulfate, cross-linked PVP-hydrogen peroxide complex, calcium pyrophosphate, PEG/PPG triblock copolymer, PEG-PPG random copolymer, polyethylene glycol, propylene glycol, polyphosphates, anionic surfactant, a fluoride source, a thickener, and one or more sweeteners, flavors, and or colors, and optionally an antioxidant (‘723 at claim 15). The reference application recites wherein the source of hydrogen peroxide comprises cross-linked PVP complexed with hydrogen peroxide in an amount from 1% - 25%, by wt., and wherein the cross-linked PVP complexed with hydrogen peroxide provides hydrogen peroxide in an amount from 0.05 - 4.5% by wt (‘723 at claim 16). The reference application recites wherein the composition is a dentifrice (‘723 at claim 18). The reference application recites a method for whitening teeth comprising the steps of (a) applying a composition according to claim 1, to the teeth, and (b) maintaining contact of the composition with the teeth for a period of time to effect whitening of the teeth contacted by the composition (‘723 at claim 19).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
c) Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/400,940 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application recites the use of polyethylene glycol which is not required by the independent claim of the instant application. The instant application recites a tooth whitening oral care composition comprising 0.01-10% potassium peroxymonosulfate by weight, stabilized with a combination of 21-60% calcium pyrophosphate (Ca2P207) and/or insoluble sodium metaphosphate ([NaPO3]n), by weight of the composition, and 20-60% polyoxyethylene/polyoxypropylene triblock copolymer,by weight of the composition (Instant claim 1).
The reference application recites a tooth whitening oral care composition comprising potassium peroxymonosulfate, calcium pyrophosphate (Ca2P207), 5-20% polyethylene glycol-400 (PEG-400), and 10-60% polyoxyethylene/polyoxypropylene triblock copolymer, by weight of the composition (940 at claim 1). The reference application recites wherein the potassium peroxymonosulfate is the only oxidizing agent present in the composition (940 at claim 2). The reference application recites wherein the composition comprises 10-40% calcium pyrophosphate (Ca2P207), by weight of the composition (‘940 at claim 3). The reference application recites wherein the composition comprises the PEG-400 in an amount of 6 to 18%, or 7 to 15%, or 8 to 14%,or9to13%,or10to15%,or10to13%,or11to15%,or11to13%,or12to14%,or12 to 13%, or about 12.5%, by weight of the composition (‘940 at claim 4). The reference application recites wherein the polyoxyethylene/polyoxypropylene triblock copolymer is a triblock copolymer having the formula HO-[CH2CH2Ol[-CH(CH3)CH20-lb[CH2CH2Ola-H,wherein a is an integer between 1 and 30, b is an integer between 10 and 60(‘940 at claim 5). The reference application recites wherein the composition further comprises one or more of polyvinylpyrrolidone, polyethylene glycol/polypropylene glycol random copolymer, polyethylene glycol, polyphosphates (e.g., alkali metal polyphosphates), and surfactants (e.g., anionic and/or zwitterionic surfactants) (‘940 at claim 6). The reference application recites wherein the composition comprises a mixture of anionic and zwitterionic surfactants (940 at claim 7). The reference application recites wherein the composition comprises a mixture of sodium lauryl sulfate and cocamidopropyl betaine (940 at claim 8). The reference application recites wherein the composition comprises 2 to 4%, or 1 to3%, or 2to3%, or 1.5 to 2.5%, or 2to 2.5%, or about 2%, of sodium lauryl sulfate, and 0.1 to 1%, or 0.1 to 0.5%, or about 0.3%, of cocamidopropyl betaine, by weight of the composition (‘940 at claim 9). The reference application recites wherein the composition further comprises an antioxidant, e.g., selected from butylated hydroxyanisole, butylated hydroxytoluene, vitamin A, carotenoids, vitamin E, flavonoids,polyphenols, ascorbic acid, and mixtures thereof (‘940 at claim 10). The reference application recites wherein the composition comprises the potassium peroxymonosulfate in an amount of 1% to 5%, 20- 40% calcium pyrophosphate, 10-15% PEG-400, and 25-50% of a polyoxyethylene/polyoxypropylene triblock copolymer having the formula HO-[CH2CH20]a[-CH(CH3)CH20-]b[CH2CH20]a-H wherein an integer between 10 and 12 (e.g., 11), and b is an integer between 15 and 20 (e.g., 16), e.g., the polymer is Pluronic L35, each by weight of the composition (‘940 at claim 11). The reference application recites wherein the composition comprises the potassium peroxymonosulfate in an amount of 1% to 3%, and the composition comprises 20-30% calcium pyrophosphate, 12-13% PEG-400, and 25- 35% of a polyoxyethylene/polyoxypropylene triblock copolymer having the formula [CHiCH2Ola[-CH(CH3)CH2O-]b[CH2CH2Ola-H, wherein an integer between 10 and 12 (e.g., 11), and b is an integer between 15 and 20 (e.g., 16), e.g., the polymer is Pluronic L35, each by weight of the composition (‘940 at claim 12). The reference application recites wherein the composition further comprises polyvinylpyrrolidone in an amount of 1 to 10%, and PEG/PPG random copolymer having an average molar ratio of ethylene glycol units (EG) to propylene glycol units (PG) of about 105-125 EG to 55-75 PG (e.g., Pluracare L1220 polymer) in an amount of 6 to 15%, and polyethylene glycol 600 in an amount of 5 to 20%, each by weight of the composition (‘940 at claim 13). The reference application recites wherein the composition further comprises 2% to 5% tetrasodium pyrophosphate and 0.5 to 1.5% disodium pyrophosphate, by weight of the composition (‘940 at claim 14). The reference application recites wherein the composition further comprises a blue dye or pigment, e.g., Blue 15 pigment (also known as CI 74160), optionally in an amount of 0.001 to 0.1% by weight of the composition, e.g.,0.01 to 0.08%, or 0.03 to 0.07%, or about 0.05%, by weight of the composition (‘940 at claim 15). The reference application recites wherein the composition further comprises 1 to 15% propylene glycol, e.g., 5 to 15%, or 5 to 10%, or about 7.5% propylene glycol, by weight of the composition (‘940 at claim 16). The reference application recites wherein the composition further comprises 2 to 10% of one or more of potassium nitrate, zinc nitrate, potassium sulfate, potassium chloride, calcium chloride, sodium chloride, or aluminum nitrate, e.g., 5 to 10%, or 10 to 15%, or 2-5%, or 3 to 8%, or about 5% (e.g., of potassium nitrate or zinc nitrate), by weight of the composition (‘940 at claim 17). The reference application recites wherein the composition is a (‘940 at claim 19). The reference application recites method for whitening teeth comprising the steps of (a) applying a composition according to claim l, to the teeth, and (b) maintaining contact of the composition with the teeth for a sufficient period of time (e.g., 0.1 to 60 minutes, or 0.1 to 30 minutes, or 0.1 to 10 minutes, or 0.1 to 5 minutes, or 0.1 to 2 minutes,or 0.1 to 1 minute) to effect whitening of the teeth contacted by the composition. (‘940 at claim 20).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
d) Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/400,906 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application requires the use of propylene glycol which is not required by the independent claim of the instant application. The instant application recites a tooth whitening oral care composition comprising 0.01-10% potassium peroxymonosulfate by weight, stabilized with a combination of 21-60% calcium pyrophosphate (Ca2P207) and/or insoluble sodium metaphosphate ([NaPO3]n), by weight of the composition, and 20-60% polyoxyethylene/polyoxypropylene triblock copolymer,by weight of the composition (Instant claim 1).
The reference application recites tooth whitening oral care composition comprising potassium peroxymonosulfate, calcium pyrophosphate (Ca2P207), 5-25% propylene glycol, and 5- 50% polyoxyethylene/polyoxypropylene triblock copolymer, by weight of the composition (‘906 at claim 1). The reference application recites wherein the potassium peroxymonosulfate is the only oxidizing agent present in the composition (906 at claim 2). The reference application recites wherein the composition comprises 10-40% calcium pyrophosphate (Ca2P207), by weight of the composition (906 at claim 3). The reference application recites wherein the composition comprises the propylene glycol in an amount of 5-25%, or 10-25%, or 15-25%, or 20-25%, or 5-20%, or 10-20%, or 15-20%, or 5-15%, or 10-15%, or 5-10%, or about 7.5%, by weight of the composition (906 at claim 4). The reference application recites wherein the polyoxyethylene/polyoxypropylene triblock copolymer is a triblock copolymer having the formula HO-[CH2CH20]a[-CH(CH3)CH20-]b[CH2CH20]a-H, wherein a is an integer between 1 and 30, b is an integer between 10 and 60 (‘906 at claim 5). The reference application recites wherein the composition further comprises one or more of polyvinylpyrrolidone, polyethylene glycol/polypropylene glycol random copolymer, polyethylene glycol, polyphosphates, and surfactants including anionic and/or zwitterionic surfactants (‘906 at claim 6). The reference application recites wherein the composition comprises a mixture of anionic and zwitterionic surfactants (‘906 at claim 7). The reference application recites wherein the composition comprises a mixture of sodium lauryl sulfate and cocamidopropyl betaine (906 at claim 8). The reference application recites wherein the composition comprises 2 to 4%, or 1 to 3%, or 2 to 3%, or 1.5 to 2.5%, or 2 to 2.5%, or about 2%, of sodium lauryl sulfate, and 0.1 to 1%, or 0.1 to 0.5%, or about 0.3%, of cocamidopropyl betaine, by weight of the composition (‘906 at claim 9). The reference application recites wherein the composition further comprises an antioxidant, comprising butylated hydroxyanisole, butylated hydroxytoluene, vitamin A, carotenoids, vitamin E, flavonoids, polyphenols,ascorbic acid, andor mixtures thereof (‘906 at claim 10). The reference application recites wherein the composition comprises the potassium peroxymonosulfate in an amount of 1% to 5%, 20-40% calcium pyrophosphate, 5-20% propylene glycol, and 15-40% of a polyoxyethylene/polyoxypropylene triblock copolymer having the formula HO-[CH2CH20]a[-CH(CH3)CH20-]b[CH2CH20]a-H, wherein a an integer between 10 and 12, and b is an integer between 15 and 20, each by weight of the composition (‘906 at claim 11). The reference application recites wherein the composition comprises the potassium peroxymonosulfate in an amount of 1% to 3%, and the composition comprises 20-30% calcium pyrophosphate, 5-25% propylene glycol, and 15-25% of a polyoxyethylene/polyoxypropylene triblock copolymer having the formula HO- [CH2CH20]a[-CH(CH3)CH2O-]b[CH2CH20]a-H, wherein a an integer between 10 and 12, and b is an integer between 15 and 20, each by weight of the composition (‘906 at claim 12). The reference application recites wherein the composition further comprises polyvinylpyrrolidone in an amount of 1 to 10%, and PEG/PPG random copolymer having an average molar ratio of ethylene glycol units (EG) to propylene glycol units (PG) of about 105-125 EG to 55-75 PG in an amount of 6 to 15%, and polyethylene glycol 600 in an amount of 5 to 20%, each by weight of the composition (‘906 at claim 13). The reference application recites wherein the composition further comprises 2% to 5% tetrasodium pyrophosphate and 0.5 to 1.5% disodium pyrophosphate, by weight of the composition (906 at claim 14). The reference application recites wherein the composition further comprises a blue dye or pigment, e.g., Blue 15 pigment (also known as CI 74160), optionally in an amount of 0.001 to 0.1% by weight of the composition, by weight of the composition (906 at claim 15). The reference application recites wherein the composition further comprises PEG 400 at 5- 20% by weight of the composition (906 at claim 16). The reference application recites wherein the composition further comprises 2 to 10% of one or more of potassium nitrate, zinc nitrate, potassium sulfate, potassium chloride, calcium chloride, sodium chloride, or aluminum nitrate, by weight of the composition (‘906 at claim 17). The reference application recites wherein the composition is a dentifrice (906 at claim 19). The reference application recites a method for whitening teeth comprising the steps of (a) applying a composition according to claim 1, to the teeth, and (b) maintaining contact of the composition with the teeth for a sufficient period of time to effect whitening of the teeth contacted by the composition (‘906 at claim 20).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
e) Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/401,008 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application recites the use of 2-10% of one or more of potassium nitrate, zinc nitrate, potassium sulfate, potassium chloride, calcium chloride, sodium chloride, or aluminum nitrate which is not required by the independent claim of the instant application. The instant application recites a tooth whitening oral care composition comprising 0.01-10% potassium peroxymonosulfate by weight, stabilized with a combination of 21-60% calcium pyrophosphate (Ca2P207) and/or insoluble sodium metaphosphate ([NaPO3]n), by weight of the composition, and 20-60% polyoxyethylene/polyoxypropylene triblock copolymer,by weight of the composition (Instant claim 1).
The reference application recites tooth whitening oral care composition comprising potassium peroxymonosulfate, calcium pyrophosphate (Ca2P207), 2-10% of one or more of potassium nitrate, zinc nitrate, potassium sulfate, potassium chloride, calcium chloride, sodium chloride, or aluminum nitrate, and 10-60% polyoxyethylene/polyoxypropylene triblock copolymer, by weight of the composition (008 at claim 1). The reference application recites wherein the potassium peroxymonosulfate is the only oxidizing agent present in the composition (008 at claim 2). The reference application recites wherein the composition comprises 10- 40% calcium pyrophosphate (Ca2P207), by weight of the composition (008 at claim 3). The reference application recites wherein the composition comprises potassium nitrate in an amount of 2-9%, or 2-8%, or 2-7%, or 2-6%, or 2-5%, or 3-9%, or 3- 8%, or 3-7%, or 3-6%, or 3-5%, or 4-9%, or 4-8%, or 4-7%, or 4-6%, or about 5%, by weight of the composition (‘008 at claim 4). The reference application recites wherein the polyoxyethylene/polyoxypropylene triblock copolymer is a triblock copolymer having the formula HO-[CH2CH20]a[-CH(CH3)CH20-]b[CH2CH20]a-H,wherein a is an integer between 1 and 30, b is an integer between 10 and 60 (‘008 at claim 5). The reference application recites wherein the composition further comprises one or more of polyvinylpyrrolidone, polyethylene glycol/polypropylene glycol random copolymer, polyethylene glycol, polyphosphates, and surfactants (008 at claim 6). The reference application recites wherein the composition comprises a mixture of anionic and zwitterionic surfactants (008 at claim 7). The reference application recites wherein the composition comprises a mixture of sodium lauryl sulfate and cocamidopropyl betaine (008 at claim 8). The reference application recites wherein the composition comprises 2 to 4%, or 1 to 3%, or 2 to 3%, or 1.5 to 2.5%, or 2 to 2.5%, or about 2%, of sodium lauryl sulfate, and 0.1 to 1%, or 0.1 to 0.5%, or about 0.3%, of cocamidopropyl betaine, by weight of the composition (008 at claim 9). The reference application recites wherein the composition further comprises an antioxidant, selected from butylated hydroxyanisole, butylated hydroxytoluene, vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid, and mixtures thereof (‘008 at claim 10). The reference application recites wherein the composition comprises the potassium peroxymonosulfate in an amount of 1% to 5%, 20-40% calcium pyrophosphate, 3- 8% potassium nitrate, and 25-50% of a polyoxyethylene/polyoxypropylene triblock copolymer having the formula HO-[CH2CH20]a[-CH(CH3)CH20-]b[CH2CH20]a-H, wherein an integer between 10 and 12, and b is an integer between 15 and 20, each by weight of the composition (‘008 at claim 11). The reference application recites wherein the composition comprises the potassium peroxymonosulfate in an amount of 1% to 3%, and the composition comprises 20- 30% calcium pyrophosphate, 4-7% potassium nitrate, and 25-35% of a polyoxyethylene/polyoxypropylene triblock copolymer having the formula HO- [CH2CH20]a[-CH(CH3)CH20-]b[CH2CH20]a-H, wherein an integer between 10 and 12, and b is an integer between 15 and 20,each by weight of the composition (‘008 at claim 12). The reference application recites wherein the composition further comprises polyvinylpyrrolidone in an amount of 1 to 10%, and PEG/PPG random copolymer having an average molar ratio of ethylene glycol units (EG) to propylene glycol units (PG) of about 105- 125 EG to 55-75 PG in an amount of 6 to 15%, and polyethylene glycol 600 in an amount of 5 to 20%, each by weight of the composition (008 at claim 13). The reference application recites wherein the composition further comprises 2% to 5% tetrasodium pyrophosphate and 0.5 to 1.5% disodium pyrophosphate,by weight of the composition (008 at claim 14). The reference application recites wherein the composition further comprises a blue dye or pigment, optionally in an amount of 0.001 to 0.1% by weight of the composition (008 at claim 15). The reference application recites wherein the composition further comprises 1 to 15% propylene glycol by weight of the composition (008 at claim 16). The reference application recites wherein the composition further comprises PEG 400 in the amount of 5- 20% by weight of the composition (008 at claim 17). The reference application recites wherein the composition is a dentifrice, including a toothpaste or a tooth gel (008 at claim 19). The reference application recites method for whitening teeth comprising the steps of (a) applying a composition according to claim 1, to the teeth, and (b) maintaining contact of the composition with the teeth for a sufficient period of time to effect whitening of the teeth contacted by the composition (‘008 at claim 20).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory 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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