DETAILED ACTION
Receipt is acknowledged of applicant’s Preliminary Amendment filed December 16, 2024.
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 .
Status of the Claims
Claims 4, 5, 7, 11, 13-18, 21 and 23 have been amended. No claims were cancelled or newly added. Accordingly, claims 1-23 are pending in the application and are currently under examination.
Information Disclosure Statement
The IDS filed January 6, 2025 has been considered. A signed copy is enclosed herewith.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites, “an ethylene oxide/propylene oxide block copolymer of the formula: HO(C2H4O)a(C3H6O)b(C2H4O)aH wherein per mole of such copolymer there are a total of about 25 to about 50 moles of ethylene oxide units and about 5 to about 11 moles of propylene oxide units, wherein a is from 50 to 400, b is about 50 to 400”. The instant specification describes the same at [0007]. A typical ethylene oxide/propylene oxide block copolymer is Pluronic F127 which has approximately 200 moles of ethylene oxide (100 units) and approximately 56-65 moles/units of propylene oxide. Example 1 of the instant specification describes Pluracare L 1220 as an ethylene oxide/polypropylene oxide block copolymer ([0061] and Table 1). Pluracare L 1220 contains 66 propylene oxide moles and 116 ethylene oxide moles which are outside the ranges of about 5 to about 11 moles of propylene oxide and about 25 to about 50 moles of ethylene oxide claimed. Typically, the number of moles and units of propylene oxide are equal in such an ethylene oxide/propylene oxide block copolymer and the number of moles of ethylene oxide is twice the number of units in such an ethylene oxide/propylene oxide block copolymer. The specification including the working example does not provide guidance as to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention.
Dependent claims 2-23 do not remedy the written description issue and as such said dependent claims suffer from the same deficiency.
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 1-23 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.
Claim 1 recites, “an ethylene oxide/propylene oxide block copolymer of the formula: HO(C2H4O)a(C3H6O)b(C2H4O)aH wherein per mole of such copolymer there are a total of about 25 to about 50 moles of ethylene oxide units and about 5 to about 11 moles of propylene oxide units, wherein a is from 50 to 400, b is about 50 to 400”. Typically, the number of moles and units of propylene oxide are equal in such an ethylene oxide/propylene oxide block copolymer and the number of moles of ethylene oxide is twice the number of units in such an ethylene oxide/propylene oxide block copolymer. The claim is indefinite because it is unclear how the claimed copolymer can have smaller amounts of moles of ethylene oxide and moles of propylene oxide than units, respectively. For purposes of art, the claims are being given its broadest most reasonable interpretation which is any ethylene oxide/propylene oxide block copolymer having the claimed formula and has either the number of moles claimed or the number of units claimed.
Claim 10 recites, “wherein the anionic surfactant comprises sodium lauryl glucose carboxylate and lauryl glucoside”. Claim 10 depends from claim 9 which recites, “wherein the non-ionic surfactant includes an alkyl polyglycolide surfactant”. Lauryl glucoside is a non-ionic surfactant and more particularly, an alkyl polyglycolide surfactant. The claim is indefinite because claim 10 sets out that lauryl glucoside is an anionic surfactant, but the claim from which it depends recites “non-ionic surfactant includes an alkyl polyglycolide surfactant" which is the genus that lauryl glucoside falls within.
Claims 18 recites, “wherein the oral care composition comprises at least one ingredient selected from the group consisting of desensitizing agents, chelating agents, whitening agents, tartar control agents, detergents, adhesion agents, foam modulators, pH modifying agents, mouth-feel agents, sweeteners, flavoring agents, colorants, preservatives, humectant and combinations thereof”. Claim 18 depends from claim 1. Claim 1 sets out that the oral care composition comprises a peroxide, a whitening agent. The claim is indefinite because it is unclear if the at least one ingredient is an additional ingredient apart from those listed in claim 1 or if the ingredients are further describing those already listed in claim 1. If the former is intended, it is suggested that the word “further” is inserted prior to “comprises” in line 2 of claim 18.
Dependent claims 2-23 do not remedy the indefinite issues and as such said dependent claims suffer from the same deficiency.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4, 11, 13, 15-19, 21, 22 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ng et al. (USPN 4,839,156, Jun. 13, 1989, hereafter as “Ng”) as evidenced by Jensen (US 2007/0183987 A1, Aug. 9, 2007, hereafter as “Jensen”).
The instant claims are drawn to an oral care composition comprising: an ethylene oxide/propylene oxide block copolymer of the formula: HO(C2H4O)a(C3H6O)b(C2H4O)aH wherein per mole of such copolymer there are a total of about 25 to about 50 moles of ethylene oxide units and about 5 to about 11 moles of propylene oxide units, wherein a is from 50 to 400, b is about 50 to 400, and the copolymer has a molecular weight of from about 1250 to 15000 kg/mol, a peroxide, and an emulsifier; wherein the ethylene oxide/propylene oxide block copolymer is in an amount of at least 20 wt% based on a total weight of the composition.
Regarding instant claims 1, 2, 4, 11, 13, 16, 17-19, 21, 22 and 23, Ng teaches stable aqueous hydrogen peroxide comprising oral care compositions (e.g., gels) (col. 1, lines 5-10) and to methods of applying them to teeth (col. 7, lines 28-39), also for removing tooth stains (col. 1, lines 22-30) which implies whitening teeth. Ng teaches that aqueous hydrogen peroxide gels can be stabilized by using a mixture of ethylene oxide/propylene oxide (in the following, the abbreviation EO/PO will be used) block copolymer in a concentration of 18-25 wt% in combination with a non-ionic surfactant (col. 3, lines 60-68; col 5, lines 5-33). Ng teaches that the non-ionic surfactant serves an emulsifying agent (col. 6, lines 9-14). An exemplified composition (Example 1) comprises (i) 25% Pluronic F127 (a composition within the scope of formula of claim 1 wherein a is about 101, b is about 56-65 and the MW is about 12,600 g/mol), (ii) 3.3% hydrogen peroxide (in a 30% solution), (iii) 1.2% of the non-ionic surfactant Tween 20, as well as flavor, the humectant polyethylene glycol and 42.1% water. After 12 weeks of accelerated ageing, less than 10% active oxygen is lost (col. 8, lines 1-12).
Regarding instant claim 15, Ng teaches the elements discussed above including an oral/dental gel. While Ng does not explicitly teach viscosity values of said gel, dental gels, generally speaking, typically have a viscosity in the range of 1000 and 200,000 cps as evidenced by Jensen ([0015]).
Regarding instant claim 18, Ng teaches the elements discussed above. Ng further teaches additional ingredients can be included such as flavoring agents, sweeteners, coloring or whitening agents, and preservatives (col. 6, lines 30-44 and 53-69; Example 1).
Thus, the teachings of Ng render the instant claims anticipated.
Claims 1-6, 11 and 13-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (US 2009/0117058 A1, May 7, 2009, hereafter as “Lee”) as evidenced by Michael Smith Engineers (see PTO-892).
The claimed invention is described above.
Regarding instant claims 1-6, 11, 13, 14, 16-22, Lee teaches a toothpaste composition for tooth whitening comprising hydrogen peroxide and an abrasive, silica (abstract; [0008]). An exemplified composition comprises (i) 22% Poloxamer 407 (also known as Pluronic F127 – having a formula of claim 1 wherein a is about 101, b is about 56-65 and the MW is about 12,600 g/mol), (ii) 0.75% hydrogen peroxide (in a 35% solution), (iii) 0.1% sodium lauryl sulfate (SLS) (an anionic emulsifier) , as well as flavor, 54% water, glycerin (a humectant) and the abrasive silica (Table 1, Formulation 1). This composition is stable over 5 weeks storage at 55°C (table 2).
Regarding instant claim 15, Lee teaches the elements discussed above including an toothpaste composition. While Lee does not explicitly teach viscosity values of said toothpaste, generally speaking, toothpastes typically have a viscosity in the range of 70,000 and 100,000 cps as evidenced by Michael Smith Engineers (Table - Pharmaceuticals).
Regarding instant claim 18, Lee teaches the elements discussed above. Lee further teaches additional ingredients can be included such as sweeteners, pH regulators, preservatives, coloring agents, foaming agents, flavors, anticaries agents, anticalculus agents, etc. can be included ([0019]).
Regarding instant claim 23, Lee teaches the elements discussed above. Lee further teaches applying the toothpaste to teeth via brushing ([0032]).
Thus, the teachings of Lee render the instant claims anticipated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2009/0117058 A1, May 7, 2009, hereafter as “Lee”), as applied to claim 1 above.
The claimed invention is described above.
Lee teaches the elements discussed above including an embodiment comprising an anionic emulsifier/surfactant, SLS.
Lee is silent to an embodiment comprising an additional surfactant, wherein the surfactant comprises an anionic, surfactant, a nonionic surfactant, or a combination thereof.
Lee teaches anionic and nonionic surfactants such as sodium lauryl sulfate, sodium N-lauroylsarcosylate, sucrose fatty acid ester, polyoxy ethylene hydrogenated castor oil and sorbitan fatty acid ester can be used alone or as a mixture of two or more ([0019]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an additional anionic and/or nonionic surfactant into the invention of Lee with a reasonable expectation of success because Lee teaches a mixture of two or more anionic and nonionic surfactants is suitable for the invention (MPEP 2144.07). Additionally, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art” (MPEP 2144.06).
Thus, the teachings of Lee render the instant claims prima facie obvious.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2009/0117058 A1, May 7, 2009, hereafter as “Lee”), as applied to claims 1, 7 and 8 above, in view of Arora et al. (US 2022/0241164 A1, Feb. 3, 2021, hereafter as “Arora”).
The claimed invention is described above.
Lee teaches the elements discussed above including the inclusion of anionic and nonionic surfactants ([0019]).
Lee is silent to the particular surfactants, an alkyl polyglucoside surfactant (instant claim 9) or sodium lauryl glucose carboxylate and lauryl glucoside (instant claim 10).
Arora teaches oral care compositions that can contain whitening agents (abstract; [0058]). Arora teaches the inclusion of surfactants such as an anionic surfactant, a non-ionic surfactant, a cationic surfactant, an amphoteric surfactant, and a combination of two or more thereof ([0036]). Arora also teaches that the surfactant can be selected from: sodium cocoyl glutamate; lauryl glucoside; sodium methyl cocoyl taurate; sodium lauroyl sarcosinate; sodium lauryl sulfate; sodium laureth sulfate; cocamidopropyl betaine; sodium cocoamphoacetate; sodium lauryl glucose carboxylate; and a combination of two or more thereof ([0036]).
Lee and Arora are both drawn to oral care compositions, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an alkyl polyglucoside surfactant (e.g., lauryl glucoside) or the combination of sodium lauryl glucose carboxylate and lauryl glucoside into the invention of Lee, as suggested by Arora, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Arora teaches that said sodium lauryl glucose carboxylate and lauryl glucoside are suitable surfactants for the invention (MPEP 2144.07). Additionally, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art” (MPEP 2144.06).
Thus, the teachings of Lee and Arora render the instant claims prima facie obvious.
Claims 1, 2, 4-8, 11-20 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Yuan et al. (US 2020/0206320 A1, Jul. 2, 2020, hereafter as “Yuan”).
The claimed invention is described above.
Regarding instant claims 1, 2, 4 and 16-18, Yuan teaches an oral care composition comprising a catalyzing enzyme and an anhydrous matrix, wherein the anhydrous matrix includes a source of hydrogen peroxide (a whitening agent), an acyl donor, a non-aqueous anhydrous liquid, and a surfactant mixture comprising sodium lauryl sulfate (an anionic emulsifier), betaine and a poloxamer (abstract). The poloxamer in the surfactant mixture may be at least one of an ethylene oxide-propylene oxide polymer or a polyethylene glycol/polypropylene glycol (PEG/PPG) copolymer in an amount about 0.5 weight % to about 20.0 weight % of the PEG/PPG copolymer and having a molecular weight of 5,000 or more Daltons (claims 1-3; [0007] and [0008]). Yuan teaches that the poloxamer can be Pluracare L1220 ([0062]; Table 1). Pluracare L1220 is known to have 66 propylene oxide moles and 116 ethylene oxide moles. Yuan exemplifies a composition containing Poloxamer L1220, SLS (an anionic emulsifier) and a peroxide (e.g., hydrogen peroxide) in an amount of 0.55% (Table 1).
However, Yuan does not teach a particular embodiment comprising at least 20 wt% of said poloxamer.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of poloxamer by way of routine experimentation with a reasonable expectation of success. A skilled artisan would have been motivated to do so because it is the normal desire of scientists or artisans to improve upon what is already generally known and determine where in a disclosed range is the optimum percentages (MPEP 2144.05). MPEP 2144.05 also states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Because the claimed range of at least 20 wt% overlaps with the range of about 0.5 weight % to about 20.0 weight % disclosed by Yuan, a prima facie case of obviousness exists. It is noted that the term “about” allows for values slightly lower and slightly higher than the recited value.
Regarding instant claims 5 and 6, Yuan teaches the elements discussed above. Yuan also teaches including an abrasive such as silica, calcium carbonate and insoluble phosphates such as calcium pyrophosphate ([0116] and [0117]; Table 1).
Regarding instant claims 7 and 8, Yuan teaches the elements discussed above. Yuan also teaches the inclusion of Poloxamer L35 which a non-ionic surfactant ([0094]; Table 1).
Regarding instant claims 11 and 12, Yuan teaches the elements discussed above including that the composition is anhydrous. Yuan defines “anhydrous” to mean that the oral care composition contains less than 10 weight % ([0038]).
While Yuan does not explicitly teach a water concentration of about 5% to about 20%, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of water by way of routine experimentation with a reasonable expectation of success. A skilled artisan would have been motivated to do so because it is the normal desire of scientists or artisans to improve upon what is already generally known and determine where in a disclosed range is the optimum percentages (MPEP 2144.05). MPEP 2144.05 also states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Because the claimed range of about 5% to about 20% overlaps with the range of less than 10 weight % disclosed by Yuan, a prima facie case of obviousness exists. It is noted that the term “about” allows for values slightly lower and slightly higher than the recited value.
Regarding instant claim 13, Yuan teaches the elements discussed above. Yuan also teaches the amount or concentration of the source of hydrogen peroxide or the hydrogen peroxide thereof in oral care compositions is not reduced by more than 15%, more than 18%, more than 20%, more than 25%, or more than 30% over a period of at least 8 weeks, at least 10 weeks, at least 12 weeks, at least 13 weeks, or greater, when aged at a temperature of at least 40° and/or at about 75% relative humidity (RH) ([0128] and [0137]; Table 2).
Regarding instant claim 14, Yuan teaches the elements discussed above. Yuan also teaches that the oral care compositions can be in the form of a toothpaste, dentifrice, a whitening strip, or a whitening gel ([0036] and [0105]).
Regarding instant claim 15, Yuan teaches the elements discussed above. Yuan also teaches that the oral care compositions have a viscosity greater than or equal to about 10,000 cP and less than or equal to about 700,000 cP ([0107]). For example, the viscosity may be about 10,000 cP, about 15,000 cP, about 20,000 cP, about 25,000 cP, or about 30,000 cP to about 35,000 cP, about 40,000 cP, about 50,000 cP, about 75,000 cP, about 100,000 cP, about 120,000 cP, about 150,000 cP, about 175,000 cP, about 200,000 cP, etc. ([0107]).
While Yuan does not explicitly teach a viscosity of about 1,000 to about 250,000 cP, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the viscosity of the composition by way of routine experimentation with a reasonable expectation of success. A skilled artisan would have been motivated to do so because it is the normal desire of scientists or artisans to improve upon what is already generally known and determine where in a disclosed range is the optimum percentages (MPEP 2144.05). MPEP 2144.05 also states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Because the claimed range of about 1,000 to about 250,000 cP overlaps with the range of about 10,000 cP and less than or equal to about 700,000 cP disclosed by Yuan, a prima facie case of obviousness exists. It is noted that the term “about” allows for values slightly lower and slightly higher than the recited value.
Regarding instant claim 18, Yuan teaches the elements discussed above. Yuan also teaches the inclusion of additional common oral care ingredients such as pH modifying agents, flavoring agents, tartar control agents, sweeteners, humectants, colorants, dyes, and pigments ([0108] and [0113]; Table 1).
Regarding instant claims 19 and 20, Yuan teaches the elements discussed above. Yuan also teaches the inclusion of a humectant such as glycerin ([0106] and [0108]).
Regarding instant claim 23, Yuan teaches the elements discussed above. Yuan also teaches applying the oral care composition to the surface of the teeth (claim 18).
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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