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 .
Election/Restrictions
Applicant's election with traverse of Group I – claims 1-19 in the reply filed on 12/28/2025 is acknowledged. The traversal is on the ground(s) that claim 20 is dependent upon claim 1 and therefore a different field of search is probably not required for each group. This is not found persuasive because as outlined in the requirement for restriction filed on 10/27/2025, the examiner has provided reasoning why the two groups would have require different searches. In the requirement for restriction filed on 10/27/2025, the examiner outlines that the groups would require at minimum different CPC classifications searching and has provided the different CPC classifications for each group. Applicant has failed to provide reasoning as to why the examiner’s reasoning, specifically the difference in classifications, is incorrect. Thus, the requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/14/2024, 07/22/2024, and 07/14/2025 are being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Claim Interpretation
In regards to claim 15, which recites the limitation of ‘optionally’, the examiner broadly interprets the term ‘optionally’ to mean anything following is not a requirement of the claim. Therefore, the concentration of the blue dye is interpreted as not being a claim requirement.
In regards to claim 18, it is noted that many of the concentration ranges of certain components (i.e. Antioxidant (e.g., BHT) 0 to 0.3%) encompass 0% which the examiner broadly interprets as the components not being a requirement of the claim as 0% encompasses the absence of said component.
In regards to claim 19, as to the limitation of 'wherein the composition is a dentifrice, e.g. , a toothpaste or tooth gel' it is noted that the instant claims are composition claims and future intended use is not given patentable weight. Thus any composition meeting the limitations of the instant claim 1 will meet this limitation.
Claim Rejections - 35 USC § 112(b)
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.
Regarding claims 6, 10-13, and 15-19, the phrase “e.g.” which is the abbreviation for "for example" renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
For the purpose of moving prosecution forward, the examiner broadly interprets any limitation following “e.g” to not be a requirement of the claim.
Claims 11-12 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.
Claims 11-12 recite “polyoxyethylene/polyoxypropylene triblock copolymer having the formula HO[CH2CH2O]a[-CH(CH3)CH2O-]b[CH2CH2O]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” which fails to define what integer is between 10 and 12. For instance, does the integer b have two ranges, or is this defining the integer a, or is there another integer that the range is defining. Therefore, the claim is rendered indefinite.
For the purpose of moving prosecution forward, the examiner broadly interprets the integer range of between 10 to 12 to be the range for the “a” integer of the formula.
Claims 11-12 and 18 contain 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 polymer and, accordingly, the identification/description is indefinite.
Claim 13 contains the trademark/trade name ‘Pluracare L1220’. 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 polymer and, accordingly, the identification/description is indefinite.
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.
Claim(s) 1-8, 10-16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Yuan et al. (US20180133129A1, published 05/17/2018, hereafter Yuan).
Yuan claims an oral composition comprising from about 0.01 to about 40% peroxysulfate whitening agent and from about 1% to about 99% non-aqueous dispersant (claim 1; according to the claim limitations of the instant claims 1-2, 4-6, 11-13, and 18). Yuan teaches the composition has a whitening efficacy ([0026]; according to the claim limitations of the instant claim 1). Claim 2 of Yuan claims the peroxysulfate whitening agent comprises potassium peroxymonosulfate (according to the claim limitations of the instant claims 1, 11-12, and 18). Claim 10 of Yuan claims the oral composition comprises from about 0.01 to about 40% MPS (potassium peroxymonosulfate [0039]) as the peroxysulfate whitening agent; from about 1% to about 99% liquid poloxamer as the non-aqueous dispersant; and from about 1% to about 60% PVP (polyvinylpyrrolidone per claim 6) as the structural binder (according to the claim limitations of the instant claims 1, 5-6, 11-13, and 18). Yuan teaches the oral care composition includes from about 0.01% to about 40% MPS, from about 0.1 to about 20% MPS, or from about 0.2 to about 10% MPS and then teaches another embodiment including MPS at about 0.5% ([0048]; according to the claim limitations of the instant claims 1, 11-12, and 18). Yuan claims the oral composition further comprises at least one of a surfactant, a thickening agent, an antioxidant, a flavoring, a sweetener, a pH modifiers, an abrasive, an anticalculus agent, a source of fluoride ions, a stannous ion source, a colorant, and a dye or pigment (according to the claim limitations of the instant claims 1, 3, 6-12, 14-15, and 17-18). Yuan teaches the abrasive is present in an amount from about 0.1 to about 60% and further teaches the abrasive is calcium pyrophosphate in a concentration of 0.01% to about 70%, and more specifically the abrasive is about 20% calcium pyrophosphate ([0081]; according to the claim limitations of the instant claims 1, 3, 11-12, and 18). Yuan claims the dispersant is a liquid or paste poloxamer and more specifically claims the dispersant comprises polyoxyethylene-polyoxypropylene glycol (claims 3-4; according to the claim limitations of the instant claims 1, 5, 11-12, and 18). Yuan teaches a list of dispersants which may include one or more of Pluronic® L35, Pluronic® L43, Pluronic® L64, Pluronic® L10, Pluronic® L44, Pluronic® L62, Pluronic® 10R5, Pluronic® 17R4, Pluronic® L25R4, Pluronic® P84, Pluronic® P65, Pluronic® P104, and Pluronic® P105. Pluronic® ([0054]; according to the claim limitations of the instant claims 1, 5, 11-12, and 18). Yuan further teaches the oral care composition includes from about 5% to about 99% L35, from about 10% to about 80% L35, or from about 20% to about 60% L35 ([0056]; according to the claim limitations of the instant claims 1, 5, 11-12, and 18). Yuan teaches the composition includes additional non-aqueous or suitable low water content dispersants in addition to a poloxamer ([0055]; according to the claim limitations of the instant claims 6, 13, 16, and 18). Yuan teaches these additional dispersants may include one or more of polyethylene glycols, such as PEG400 and PEG600, or polyethylene/polypropylene glycol copolymers, such as PEG/PPG 38/8 and PEG/PPG-116/66 ([0055]; according to the claim limitations of the instant claims 6, 13, 16, and 18). Yuan claims the structural builder is PVP in an amount from about 1% to about 60% and further teaches the concentration of PVP to be from about 1% to about 60% PVP, from about 5% to about 50% PVP, or from about 10% to about 40% PVP. (claims 9-10, 16, and 19 and [0065]; according to the claim limitations of the instant claims 6, 13, and 18). Yuan teaches the surfactants can be anionic, nonionic, cationic, amphoteric or a combination of surfactants ([0068]; according to the claim limitations of the instant claims 6-9, and 18). Yuan further teaches the surfactant to be in an amount of 0.01 to about 20.0% and specifically teaches the surfactant to be sodium lauryl sulfate at about 2% ([0069]; according to the claim limitations of the instant claims 6-9 and 18). Yuan further teaches cocamidopropyl betaine to be a suitable amphoteric surfactant ([0068]; according to the claim limitations of the instant claims 6-9 and 18). Yuan teaches acceptable antioxidants to include BHA, BHT, vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid, and mixtures therefore ([0072]; according to the claim limitations of the instant claims 10 and 18). Further, Yuan teaches the concentration of the antioxidant in the oral care composition includes from about 0.001% to about 1%, and in one embodiment includes about 0.03% antioxidant ([0072]; according to the claim limitations of the instant claims 10 and 18). Yuan teaches the oral composition has one or more pH modifying agents in an amount of from about 0.01% to about 10% ([0076]; according to the claim limitations of the instant claims 14 and 18). Yuan further teaches an example composition may include about 0.9% sodium acid pyrophosphate (also known as disodium pyrophosphate) and about 2% tetrasodium pyrophosphate as the pH modifier ([0076]; according to the claim limitations of the instant claims 14 and 18). Yuan teaches the colorants, such as dyes or pigments, may be FD%C Blue No. 1 (disodium salt of dibenzyldiethyl-diamino-triphenylcarbinol trisulfonic acid anhydrite), FD&C Blue No. 2 (sodium salt of disulfonic acid of indigotin), or mixtures thereof ([0077]; according to the claim limitations of the instant claims 15 and 18). Yuan provides a comparative oral care composition example comprising: 0.5% MPS, 20% insoluble phosphate abrasive, 5.75% PVP, 1.75% thickening agent, 1.98% flavoring agents and sweeteners, 2% pH modifying agents, 0.03% butylated hydroxytoluene, 1.1% sodium monofluorophosphate, 0.2% phosphoric acid, 34.43% glycerin, 15.95% propylene glycol, 6.31% polyethylene glycol 600, 7.5% polyethylene glycol/polypropylene glycol 116/66 copolymer, and 2% sodium lauryl sulfate ([0093]; according to the claim limitations of the instant claims 1-13 and 18). Yuan teaches that the most commonly used whitening active ingredients are peroxides, such as hydrogen peroxide, however, in high concentrations, hydrogen peroxide can be irritating to the teeth and gums and, in addition, hydrogen peroxide is an unstable molecule that is prone to decomposition, especially in aqueous environments ([0001]; according to the claim limitations of the instant claim 2). Further, Yuan teaches that there is a desire for oral care composition using non-hydrogen peroxide oxidizing agents, such as peroxysulfuric acid or peroxysulfates, which are stable ([0003]; according to the claim limitations of the instant claim 2). Lastly, Yuan claims the oral composition is a dentifrice and further teaches the composition being applied to the tooth surface (claim 18 and [0022-0023]; according to the claim limitations of the instant claim 19).
Yuan does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Yeo with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Yuan et al. (US20180133129A1, published 05/17/2018, hereafter Yuan) in view of Costacurta et al. (Costacurta AO, Borges CE, Centenaro C, Correr GM, Kaizer MR, Gonzaga CC. The bleaching efficacy of carbamide peroxide gels containing potassium nitrate desensitizer. J Clin Exp Dent. 2020 Jul 1;12(7):e644-e649. doi: 10.4317/jced.56917. PMID: 32905070; PMCID: PMC7462381., hereafter Costacurta).
As outlined above, Yuan teaches an oral whitening composition comprising potassium peroxymonosulfate, calcium pyrophosphate, propylene glycol, and polyoxyethylene/polyoxypropylene triblock copolymer at the desired concentrations.
Yuan fails to teach the addition of potassium nitrate, zinc nitrate, potassium sulfate, potassium chloride, calcium chloride, sodium chloride, or aluminum nitrate at a concentration of 2-10% as in instant claim 17.
Costacurta teaches a teeth bleaching gel containing potassium nitrate as a desensitizer (title and page e644, materials and methods). Costacurta teaches the gel having 3% potassium nitrate (page eg44, materials and methods). Costacurta teaches that many teeth bleaching agents result in tooth sensitivity and potassium nitrate is able to reduce tooth sensitivity by decreasing the ability of dental pulp nerve fibers to repolarize after initial depolarization due to pain (page e645, paragraph 2). Lastly, Costacurta teaches that the addition of potassium nitrate would not influence the bleaching efficiency (page e644, conclusion).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention would modify a tooth whitening oral composition comprising potassium peroxymonosulfate, calcium pyrophosphate, propylene glycol, and polyoxyethylene/polyoxypropylene triblock copolymer as outlined by Yuan by addition of potassium nitrate as outlined by Costacurta under TSM, see MPEP 2143(G). As outlined by Costacurta, adding potassium nitrate to a tooth whitening composition reduces the sensitivity to the whitening agent while maintaining whitening efficiency which would motivate someone skilled in the art to advantageously combine potassium nitrate with the composition of Yuan as it would have a reasonable expectation of success.
Claim(s) 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Yuan et al. (US20180133129A1, published 05/17/2018, hereafter Yuan) in view of Leinen et al (EP1257247B1, published 10/11/2006, English translation by Google, hereafter Leinen).
As outlined above, Yuan teaches a composition comprising potassium peroxymonosulfate, calcium pyrophosphate, PEG/PPG triblock copolymer, propylene glycol, PVP, PEG-PPG random copolymer, polyethylene glycol, polyphosphates, sodium lauryl sulfate (anionic surfactant), antioxidant, and sweeteners and flavors all at the desired concentrations. Additionally, outlined above, Yuan teaches the addition of cocamidopropyl betaine and blue dye or pigment.
Further, Yuan teaches the composition comprises one or more flavoring agents in an amount from about 0.01 to about 5%, from about 0.05% to about 2%, and from about 0.1% to about 3%, from about 0.2% to about 2.5%, or about 1.5% flavoring agents based on a total weight of the oral care composition ([0074]; according to the claim limitations of the instant claim 18). Additionally, Yuan teaches the composition includes a fluoride source, specifically monofluorophosphate, at a concentration of about 0.01 to about 10% ([0084]; according to the claim limitations of the instant claim 18). Lastly, Yuan teaches the addition of a thickening agent, specifically fumed silica, and teaches the concentration of the agent to be from about 0.5 to about 35%, specifically about 2.3% fumed silica ([0071]; according to the claim limitations of the instant claim 18).
Although Yuan teaches the addition of cocoamidopropyl betaine, Yuan fails to teach the amount of cocoamidopropyl betaine as in instant claims 9 and 18. Further, Yuan fails to teach the concentration of blue dye as claimed as in instant claim 18.
Leinen teaches a tooth cleaning agent composition suitable for the production of a tooth whitening agent for the cleaning and care of the teeth (title and page 2, last paragraph). Leinen teaches the composition can be used as a dentifrice, specifically as a paste or gel, and usually contains polishes, humectants, surfactants, binders, flavorings and fluoride-containing and antimicrobial agents (page 2, description, paragraph 2). Leinen teaches the addition of metaphosphates for polish such as calcium pyrophosphate (page 3, last paragraph). Leinen teaches the addition of humectants, such as propylene glycol (page 4, humectants, paragraph 1). Leinen teaches in order to achieve an intensive cleaning effect in combination with good foaming and sufficient solubilization of the propellant gases, a mixture of anionic and nonionic surfactants or a mixture of anionic surfactant, nonionic surfactant and betaine is preferably used in the compositions according to the invention, for example sodium lauryl sulfate / PEG-30 glyceryl stearate / cocamidopropyl (page 4, nonionic surfactants, paragraph 3). Leinen provides multiple example compositions comprising 1.5 % by weight sodium lauryl sulfate, 0.6% by weight cocamidopropyl betaine, and 0.26% by weight of dye solution, specifically to include blue FCF dye (page 7, examples 1-4).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim a tooth whitening oral care composition comprising blue dye, cocamidopropyl betaine, potassium peroxymonosulfate, calcium pyrophosphate, PEG/PPG triblock copolymer, propylene glycol, PVP, PEG-PPG random copolymer, polyethylene glycol, polyphosphates, sodium lauryl sulfate (anionic surfactant), antioxidant, and sweeteners and flavors as outlined by Yuan with the ready for improvement with the known technique of adjusting the concentration of the cocamidopropyl betaine and the blue dye as outlined by Leinen. Adjusting the forementioned components of a tooth whitening composition as claimed by instant claims 9 and 18 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 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.
18/400,940 claims a tooth whitening oral care composition comprising potassium peroxymonosulfate, calcium pyrophosphate (Ca2P2O7), 5-20% polyethylene glycol-400 (PEG-400), and 10-60% polyoxyethylene/polyoxypropylene triblock copolymer (claim 1; according to the claim limitations of the instant claims 1, 4, 11-12, 16, and 18). Claim 2 of 18/400,940 claims the potassium peroxymonosulfate is the only oxidizing agent present in the composition (according to the claim limitations of the instant claim 2). Claim 3 of 18/400,940 claims the composition comprises 10-40% calcium pyrophosphate (Ca2P2O7) (according to the claim limitations of the instant claims 1, 3, 11-12, and 18). Claim 4 of 18/400,940 claims the composition comprises the PEG-400 in an amount of 6 to 18% or 7 to 15%, or 8 to 14%, or 9 to 13%, or 10 to 15%, or 10 to 13%, or 11 to 15%, or 11 to 13%, or 12 to 14%, or 12 to 13%, or about 12.5%, by weight of the composition (according to the claim limitations of the instant claims 1, 4, 11-12, 16, and 18). Claim 5 of 18/400,940 claims the polyoxyethylene/polyoxypropylene triblock copolymer is a triblock copolymer having the formula:
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(according to the claim limitations of the instant claims 1, 5, 11-12, and 18). Claim 6 of 18/400,940 claims 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) (according to the claim limitations of the instant claims 6-9, 13, and 18). Claim 7 of 18/400,940 claims the composition comprises a mixture of anionic and zwitterionic surfactants (according to the claim limitations of the instant claims 6-9 and 18). Claim 8 of 18/400,940 claims the composition comprises a mixture of sodium lauryl sulfate and cocamidopropyl betaine (according to the claim limitations of the instant claims 6-9 and 18). Claim 9 of 18/400,940 claims 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 (according to the claim limitations of the instant claims 6-9 and 18). Claim 10 of 18/400,940 claims 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 (according to the claim limitations of the instant claims 10 and 18). Claim 11 of 18/400,940 claims the composition comprises the potassium peroxymonosulfate in an amount of 1% to 5%, 20 to 40% calcium pyrophosphate, 10-15% PEG-400, 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 (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 (according to the claim limitations of the instant claims 1, 5, 11-12, and 18). Claim 12 of 18/400,940 claims the composition comprises the potassium peroxymonosulfate in an amount of 1% to 3%, 20 to 30% calcium pyrophosphate, 12-13% PEG-400, and 25-35% 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 (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 (according to the claim limitations of the instant claims 1, 5, 11-12, and 18). Claim 13 of 18/400,940 claims 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 (according to the claim limitations of the instant claims 13 and 18). Claim 14 of 18/400,940 claims the composition further comprises 2% to 5% tetrasodium pyrophosphate and 0.5 to 1.5% disodium pyrophosphate, by weight of the composition (according to the claim limitations of the instant claims 14 and 18). Claim 15 of 18/400,940 claims 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 (according to the claim limitations of the instant claims 15 and 18). Claim 16 of 18/400,940 claims 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 (according to the claim limitations of the instant claims 1, 4, 11-12, and 18). Claim 17 of 18/400,940 claims 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 (according to the claim limitations of the instant claims 17-18). Claim 18 of 18/400,940 claims the composition comprises:
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or
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(according to the claim limitations of the instant claims 1-17). Claim 19 of 18/400,940 claims the composition is a dentifrice, e.g., a tooth paste or tooth gel (according to the limitations of the instant claim 19).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 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.
18/401,008 claims a tooth whitening oral care composition comprising potassium peroxymonosulfate, calcium pyrophosphate (Ca2P2O7), 2-10% of one or more of potassium nitrate, zinc nitrate, potassium sulfate, potassium chloride, calcium chloride, sodium chloride, or aluminum nitrate (e.g. potassium nitrate), and 10-60% polyoxyethylene/polyoxypropylene triblock copolymer, by weight of the composition (claim 1; according to the claim limitations of the instant claims 1, 3, 5, 11-12, and 17-18). Claim 2 of 18/401,008 claims the potassium peroxymonosulfate is the only oxidizing agent present in the composition (according to the claim limitations of the instant claim 2). Claim 3 of 18/401,008 claims the composition comprises 10-40% calcium pyrophosphate (Ca2P2O7), by weight of the composition (according to the claim limitations of the instant claims 1, 3, 11-12, and 18). Claim 4 of 18/401,008 claims 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 (according to the composition of the instant claims 17-18). Claim 5 of 18/401,008 claims polyoxyethylene/polyoxypropylene triblock copolymer is a triblock copolymer having the formula:
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(according to the claim limitations of the instant claims 1, 5, 11-12, and 18). Claim 6 of 18/401,008 claims 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) (according to the claim limitations of the instant claims 6 and 18). Claim 7 of 18/401,008 claims the composition comprises a mixture of anionic and zwitterionic surfactants (according to the claim limitations of the instant claims 6-9 and 18). Claim 8 of 18/401,008 claims the composition comprises a mixture of sodium lauryl sulfate and cocamidopropyl betaine (according to the claim limitations of the instant claims 6-9 and 18). Claim 9 of 18/401,008 claims the composition comprises 2 to 4%, or 1 to 3%, or 2 to 3%, or 1.5 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 (according to the claim limitation of the instant claims 6-9 and 18). Claim 10 of 18/401,008 claims 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 (according to the claim limitations of the instant claims 10 and 18). Claim 11 of 18/401,008 claims 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-[CH2CH2O]a[-CH(CH3)CH2O-]b[CH2CH2O]a-H, wherein the 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 (according to the claim limitations of the instant claims 1, 3, 5, 11-12, and 17-18). Claim 12 of 18/401,008 claims 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-[CH2CH2O]a[-CH(CH3)CH2O-]b[CH2CH2O]a-H, wherein the 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 (according to the claim limitations of the instant claims 1, 3, 5, 11-12, and 17-18). Claim 13 of 18/401,008 claims 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 L 1220 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 (according to the claim limitations of the instant claims 6 and 18). Claim 14 of 18/401,008 claims the composition further comprises 2% to 5% tetrasodium pyrophosphate and 0.5 to 1.5% disodium pyrophosphate, by the weight of the composition (according to the claim limitations of the instant claims 14 and 18). Claim 15 of 18/401,008 claims 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 the weight of the composition (according to the claim limitations of the instant claims 15 and 18). Claim 16 of 18/401,008 claims 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 (according to the claim limitations of the instant claims 11, 4, 11-12, and 18). Claim 17 of 18/401,008 claims the composition further comprises PEG 400 (e.g., at 5-20% by the weight of the composition, e.g., 6-18%, or 10-15%, or about 12.5%) (according to the claim limitations of the instant claims 16 and 18). Claim 18 of 18/401,008 claims the composition comprises:
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(according to the claim limitations of the instant claims 1-18). Claim 19 of 18/401,008 claims the composition is a dentifrice, e.g., a toothpaste or tooth gel (according to the claim limitations of the instant claim 19).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 5-16, and 21 of copending Application No. 18/088,448 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
18/088,448 claims 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 (claim 1; according to the claim limitations of the instant claims 1-6, 11-13, and 18). Claim 2 of 18/088,448 claims the potassium peroxymonosulfate is the only oxidizing agent present in the composition (according to the claim limitations of the instant claim 2). Claim 3 of 18/088,448 claims the composition is stabilized by 23% to 27% calcium pyrophosphate (Ca2P2O7), by weight of the composition (according to the claim limitations of the instant claims 1, 3, 11-12, and 18). Claim 4 of 18/088,448 claims the composition comprises the calcium pyrophosphate in an amount of 24% to 26%, or about 25%, by weight of the composition (according to the claim limitations of the instant claims 1, 3, 11-12, and 18). Claim 6 of 18/088,448 claims the composition further comprises one or more of alkali metal polyphosphates, and anionic and/or zwitterionic surfactants (according to the claim limitations of the instant claims 6-9 and 18). Claim 7 of 18/088,448 claims the composition comprises a mixture of anionic and zwitterionic surfactants (according to the claim limitations of the instant claims 6-9 and 18). Claim 8 of 18/088,448 claims the composition comprises a mixture of sodium lauryl sulfate and cocamidopropyl betaine (according to the claim limitations of the instant claims 6-9 and 18). Claim 9 of 18/088,448 claims the composition comprises 2 to 4%, or 1 to 3%, or 2 to 3%, or 1.5 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 (according to the claim limitations of the instant claims 6-9 and 18). Claim 10 of 18/088,448 claims the composition further comprises an antioxidant selected from butylated hydroxyanisole, butylated hydroxytoluene, vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid, and mixtures thereof (according to the claim limitations of the instant claims 10 and 18). Claim 11 of 18/088,448 claims 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 (according to the claim limitations of the instant claims 13, 16, and 18). Claim 12 of 18/088,448 claims the composition comprises the potassium peroxymonosulfate in an amount of 1% to 3%, by weight of the composition (according to the claim limitations of the instant claims 1, 11-12, and 18). Claim 13 of 18/088,448 claims 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 (according to the claim limitations of the instant claims 6, 13, and 18). Claim 14 of 18/088,448 claims the composition further comprises 2% to 5% tetrasodium pyrophosphate and 0.5 to 1.5% disodium pyrophosphate, by weight of the composition (according to the claim limitations of the instant claims 14 and 18). Claim 15 of 18/088,448 claims the composition further comprises a blue dye or pigment, optionally in an amount of 0.001 to 0.1% by weight of the composition (according to the claim limitations of the instant claims 15 and 18). Claim 16 of 18/088,448 claims the composition comprises:
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(according to the claim limitations of the instant claims 1-18). Lastly, claim 21 of 18/088,448 claims the composition 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 (according to the claim limitations of the instant claims 1, 5-6, 11-12, 14, and 18).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-15, and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 7-15, and 17-18 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.
18/463,723 claims a tooth whitening oral care composition comprising (a) 0.01-10% potassium peroxymonosulfate by weight of the composition, 5%-60% an abrasive selected from calcium pyrophosphate (Ca2P207), insoluble sodium metaphosphate ([NaPO3]n), anhydrous dicalcium phosphate (CaHPO4), or mixtures thereof, by weight of the composition (claim 1; according to the claim limitations of the instant claims 1, 3, 11-12, and 18). Claim 2 of 18/463,723 claims 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 (according to the claim limitations of the instant claims 1, 11-12, and 18). Claim 4 of 18/463,723 claims the composition comprises 5- 60% calcium pyrophosphate (Ca2P207) by weight of the composition (according to the claim limitations of the instant claims 1, 3, 11-12, and 18). Claim 7 of 18/463,723 claims 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 (according to the claim limitations of the instant claims 1, 5, 11-12, and 18). Claim 8 of 18/463,723 claims the composition further comprises one or more of polyvinylpyrrolidone (e.g., from 1%-50% by wt.), polyethylene glycol (e.g., from 0.5%-50% by wt.), humectants (e.g., polypropylene glycol, e.g., 1-20% by weight), polyphosphates (e.g., alkali metal polyphosphates, e.g., 0.1-5% by weight),surfactants (e.g., anionic and/or zwitterionic surfactants, e.g., 0.1-6% by weight), and thickening agents (e.g. fumed silica and/or sodium stearate, e.g., 0.1-10% by weight) (according to the claim limitations of the instant claims 6-9, 13-14, and 18). Claim 9 of 18/463,723 claims the composition comprises sodium lauryl sulfate and/or cocamidopropyl betaine (according to the claim limitations of the instant claims 6-9 and 18). Claim 10 of 18/463,723 claims 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 (according to the claim limitations of the instant claims 6-9 and 18). Claim 11 of 18/463,723 claims the composition further comprises a polyethylene glycol/polypropylene glycol random copolymer (PEG/PPG copolymer, 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 (according to the claim limitations of the instant claims 6, 13, and 18). Claim 12 of 18/463,723 claims the composition further comprises a humectant (e.g., glycerol, sorbitol, xylitol, propylene glycol, or a mixture thereof),optionally wherein the humectant comprises propylene glycol in an amount of 1 to 20% by weight of the composition (according to the claim limitations of the instant claims 1, 4, 11-12, and 18). Claim 13 of 18/463,723 claims the composition further comprises one or more thickening agents, e.g., sodium stearate, magnesium aluminum silicate, or fumed silica, optionally in an amount of 0.1% to 10% by weight of the composition, e.g., 1% to 10%, or 2.5% to 10%, or 3% to 10%, or 2.5% to 7.5%, or 3% to 8%, or 3% to 6%,or 3% to 5%, or 3% to 4%, or about 3%, or about 3.5%, or about 4%, or about 5%, by weight of the composition (according to the claim limitations of the instant claim 18). Claim 14 of 18/463,723 claims the composition comprises cross-linked polyvinylpyrrolidone and fumed silica, or sodium stearate and fumed silica (according to the claim limitations of the instant claims 6, 13, and 18). Claim 15 of 18/463,723 claims the composition comprises or consists of: (A) potassium peroxymonosulfate (e.g., as MPS triple salt), cross-linked PVP-hydrogen peroxide complex, calcium pyrophosphate, PEG/PPG triblock copolymer (e.g., poloxamer 408), polyvinylpyrrolidone, PEG-PPG random copolymer (e.g.,PEG/PPG-116/66), polyethylene glycol (e.g., PEG-600), polyphosphates (e.g., sodium pyrophosphates), anionic surfactant (e.g., sodium lauryl sulfate), zwitterionic surfactant (e.g., cocamidopropyl betaine), a fluoride source (e.g., sodium monofluorophosphate), a thickener (e.g., fumed silica or sodium stearate), and one or more sweeteners, flavors, and or colors, and optionally propylene glycol, and optionally an antioxidant (e.g., BHT); or (B) potassium peroxymonosulfate (e.g., as MPS triple salt), cross-linked PVP-hydrogen peroxide complex, calcium pyrophosphate, PEG/PPG triblock copolymer (e.g., poloxamer 408), polyvinylpyrrolidone, PEG-PPG random copolymer (e.g., PEG/PPG- 116/66), polyethylene glycol (e.g., PEG-600), polyphosphates (e.g., sodium pyrophosphates), anionic surfactant (e.g., sodium lauryl sulfate), a fluoride source (e.g., sodium monofluorophosphate), a thickener (e.g., fumed silica), and one or more sweeteners, flavors, and or colors, and optionally propylene glycol, and optionally an antioxidant (e.g., BHT); or (C) potassium peroxymonosulfate (e.g., as MPS triple salt), cross-linked PVP-hydrogen peroxide complex, calcium pyrophosphate, PEG/PPG triblock copolymer (e.g., poloxamer 408), PEG-PPG random copolymer (e.g., PEG/PPG-116/66), polyethylene glycol (e.g., PEG-600), propylene glycol, polyphosphates (e.g., sodium pyrophosphates), anionic surfactant (e.g., sodium lauryl sulfate), a fluoride source (e.g., sodium monofluorophosphate), a thickener (e.g., fumed silica), and one or more sweeteners, flavors, and or colors, and optionally an antioxidant (e.g., BHT) (according to the claim limitations of the instant claims 1, 3-15, and 17-18). Claim 17 of 18/463,723 claims the composition comprises or consists of:
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(according to the claim limitations of the instant claims 1, 3-15, and 17-18). Lastly, claim 18 of 18/463,723 claims the composition is a dentifrice (according to the claim limitations of the instant claim 19).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA NICOLE ISNOR whose telephone number is (703)756-5561. The examiner can normally be reached Monday-Friday 5:30am-3pm PST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./Examiner, Art Unit 1611