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 .
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 2-10 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.
Instant claims 2 and 4 recite “0.1% to .0.5%” and “.001% to .0.1%”, respectively. The erroneous decimal points amount to more than a typo, and render the claims indefinite, because the claims as a whole recite decimals with and without the preceding zero and so it is not clear how “.0.5%” and “.0.1%” should be interpreted. The claims will be examined with the broadest reasonable interpretation of these ranges, i.e., “0.1% to 0.5%” and “.001% to 0.1%” for claims 2 and 4 respectively. The Examiner will also respectfully note that reciting all decimals with a preceding zero, e.g., 0.1% as opposed to .1% (claim 4), would make the claims easier to read.
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.
1) Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kavouklis et al. (US 2008/0025926 A1, publication date 01/31/2008) in view of Kahwaty (US 2006/0099154 A1, publication date 05/11/2006).
Kavouklis relates to oral compositions comprising hydrogen peroxide and lycopene [title] and discloses, inter alia, a whitening gel formulation “which comprises hydrogen peroxide; and pH adjuster, and wherein the hydrogen peroxide and the pH adjuster have been combined in the whitening gel formulation for not more than about seven minutes prior to administration to an individual” [abstract]. The “whitening gel is provided in a container having a dual chamber” [0130] with sodium hydroxide as a pH adjustor [0138] and is formulated according to Table 3 on page 10, see below:
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Kavouklis also discloses that “[s]odium benzoate can be introduced to about 0.01 %-0.90% by weight” (i.e., instant claim 2) [0067].
Kavouklis differs from the instant claims insofar as it does not disclose sodium bicarbonate.
Kahwaty relates to dental whitening methods that comprise the separate application of a whitening component and a desensitizing component (i.e., two component whitening system) [abstract]. The whitening component may comprise hydrogen peroxide [0021]. The desensitizing component may comprise pH adjusting agents such as sodium hydroxide or sodium bicarbonate in amounts from 0.01-10% w/w [0048].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have substituted the sodium bicarbonate Kahwaty in place of the sodium hydroxide of Kavouklis because Kahwaty discloses sodium hydroxide and sodium bicarbonate are suitable for the same purpose in the same context and in the same amounts. One would have had an expectation of success because Kahwaty discloses sodium bicarbonate and sodium hydroxide are both suitable pH adjusters for two component hydrogen peroxide teeth whitening system. The simple substitution of one known element (e.g., the sodium bicarbonate) in place of another (e.g., the sodium hydroxide) in order to achieve predictable results (pH adjusting agent) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
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). In the present case the instantly claimed amounts overlap with the prior art and so a prima facie case of obviousness exists for each. See table below.
Component
Claimed Range (%w/w)
Prior Art Range (%w/w)
Prior Art Citation
Sodium bicarbonate
0.0001-1
0.01-10
Kahwaty; [0048]
Xylitol
8-15
0.1-15
Kavouklis; Table 3
Sorbitol (70%)
10-17 (i.e., 7-11.9% w/w sorbitol)
0.1-15
Kavouklis; Table 3
Glycerin
12-17
1-15
Kavouklis; Table 3
Water
60-70
5-80
Kavouklis; Table 3
Sodium benzoate
0.1-.5 (claim 2)
0.01-0.9
Kavouklis; [0067]
As noted in the table above, sorbitol 70% in amounts from 10-17% w/w reads on pure sorbitol in amounts from 7-11.8% w/w.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a composition comprising sodium bicarbonate, xylitol, sorbitol, glycerin, water and sodium benzoate in the instantly claimed amounts.
2) Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kavouklis et al. (US 2008/0025926 A1, publication date 01/31/2008) in view of Kahwaty (US 2006/0099154 A1, publication date 05/11/2006) as applied to claims 1 and 2 above, and further in view of Ng et al. (US 4839156, date of patent 06/13/1989).
Kavouklis and Kahwaty, which are taught above, differ from the instant claims insofar as they do not disclose sodium benzoate in the hydrogen peroxide component. However, Kavouklis desires preservatives [0071]. Kavouklis also discloses “the whitening gel is provided in a container having a dual chamber” (i.e., first and second vessel; instant claim 11)[0130]. The whitening compositions of the two component gel discussed above comprises 3-15% w/w hydrogen peroxide (see Table 3 on page 10, reproduced below):
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Ng relates to stable hydrogen peroxide dental gels [abstract] which may be provided in a dual compartment container or kit with a bicarbonate dentifrice [col. 7, lines 14-15]. According to Ng the composition may comprise preservatives, such as sodium benzoate, in amounts up to 1% [col. 6, lines 53-57].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07. In the present case it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have selected the sodium benzoate of Ng for the preservative desired by Kavouklis because Ng discloses sodium benzoate is a suitable preservative for hydrogen peroxide dentifrices provided in a dual container with a bicarbonate dentifrice.
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). In the present case, the instantly claimed range of sodium benzoate (0.001-0.5 % w/w of the peroxide solution) and hydrogen peroxide (1-3% of the hydrogen peroxide solution) overlap with the prior art ranges for sodium benzoate (up to 1% w/w of the peroxide dentifrice) and hydrogen peroxide (1-3% w/w of the hydrogen peroxide component), and so a prima facie case of obviousness exists for both ranges.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided a compositions comprising hydrogen peroxide and sodium benzoate within the instantly claimed amounts in a first vessel (i.e., chamber 1 of Kavouklis) and the composition taught by Kavouklis and Kahwaty, as discussed above, which comprises sodium bicarbonate, xylitol, sorbitol, glycerin, water and sodium benzoate, within the instantly claimed amounts, in a second vessel (i.e., chamber 2 of Kavouklis).
3) Claim(s) 3-4 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kavouklis et al. (US 2008/0025926 A1, publication date 01/31/2008) in view of Kahwaty (US 2006/0099154 A1, publication date 05/11/2006) and Ng et al. (US 4839156, date of patent 06/13/1989) as applied to claims 1, 2, 11 and 12 above, and further in view of Coleman (US20200390685A1, publication date 07/13/2021).
Kavouklis, Kahwaty, and Ng, which are taught above, differ from the instant claims insofar as they do not disclose stevia. However, Kavouklis desires natural sweeteners [0058].
Coleman relates to oral care compositions for whitening teeth [abstract & 0005] which may comprise hydrogen peroxide (see row 22 of Table 4 on page 5). According to Coleman the toothpaste may comprise “natural or naturally derived sweeteners including, but not limited to, stevia or stevia extract” in amounts less than 1% w/w [0015].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07. In the present case it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have selected the stevia of Coleman for the natural sweetener desired by Kavouklis because Coleman discloses stevia is a suitable natural sweetener for whitening oral care compositions.
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). In the present case, the instantly claimed range of 0.01-0.1% w/w stevia overlaps with the prior art range of less than 1% w/w stevia and so a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the composition of the second vessel (i.e., chamber 2) taught by Kavouklis, Kahwaty and Ng, as discussed above, to comprise stevia within the instantly claimed amounts.
Regarding instant claim 4 and 14, Kavouklis discloses agents such as PEG-40 hydrogenated castor oil “can also be incorporated for imparting flavor, or masking distasteful components” [0064].
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). In the present case, a skilled artisan would have been motivated to optimize the amount of PEG-40 hydrogenated castor oil to achieve optimal flavor.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the composition of the second vessel (i.e., chamber 2) taught by Kavouklis, Kahwaty, Ng and Coleman, as discussed above, to comprise PEG-40 hydrogenated castor oil within the instantly claimed amounts.
4) Claim(s) 5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kavouklis et al. (US 2008/0025926 A1, publication date 01/31/2008) in view of Kahwaty (US 2006/0099154 A1, publication date 05/11/2006) and Ng et al. (US 4839156, date of patent 06/13/1989) and Coleman (US20200390685A1, publication date 07/13/2021) as applied to claims 1-4 and 11-14 above, and further in view of Dixit et al. (US 2005/0207997 A1, publication date 09/22/2005).
Kavouklis, Kahwaty, Ng and Coleman, which are taught above, differ from the instant claims insofar as they do not teach calcium lactate. However, Kavouklis desires active agents for plaque [0059]
Dixit relates to dual component dentifrices for whitening wherein the first component comprises a whitening agent and the second component comprises an agent that is incompatible with the whitening agent [title &abstract]. Dixit discloses antiplaque agents for the dual component whitening compositions include calcium lactate [0044].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the calcium lactate of Dixit with the compositions taught by Kavouklis, Kahwaty, Ng, and Coleman. One would have been motivated, and had an expectation of success, because Kavouklis desires components for plaque and Dixit discloses calcium lactate has the desirable effect of disrupting plaque in dual component whitening formulations. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). In the present case, a skilled artisan would have been motivated to optimize the amount of calcium lactate to achieve optimal plaque disruption.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the composition of the second vessel (i.e., chamber 2) taught by Kavouklis, Kahwaty, Ng, and Coleman, as discussed above, to comprise calcium lactate within the instantly claimed amounts.
5) Claim(s) 6-10 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kavouklis et al. (US 2008/0025926 A1, publication date 01/31/2008) in view of Kahwaty (US 2006/0099154 A1, publication date 05/11/2006) and Ng et al. (US 4839156, date of patent 06/13/1989) and Coleman (US20200390685A1, publication date 07/13/2021) and Dixit et al. (US 2005/0207997 A1, publication date 09/22/2005) as applied to claims 1-5 and 11-15 above, and further in view of KR’091 (KR 102638091 B1, publication date 02/21/2024; citing English machine translation) and Abu-Seida et al. (International Arab Journal of Dentistry, 2023, v. 14, issue 2, article 18, p.188-199).
Kavouklis, Kahwaty, Ng, Coleman and Dixit, which are taught above, differ from the instant claims insofar as they do not teach aloe vera. However, Kavouklis does desire antioxidants and biocides [0071].
KR’091 relates to whitening toothpaste compositions [title & abstract]. According to KR’091 0.06-0.1% w/w aloe may be added to the composition for its antioxidant activity and antibacterial activity [p. 16, last paragraph]. KR’091 also discloses aloe has ant-inflammatory activity and tissue formation activity [p. 16, last paragraph].
Abu-Seida relates to aloe vera in dentistry and discloses that “[i]n dental practice, AV [aloe vera] has different applications and it attracts the attention of researchers due to its natural origin, low cytotoxicity, and various biological actions like anti-microbial, immunomodulatory, anti-inflammatory, antioxidant, wound healing, and antineoplastic actions” [abstract].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07. In the present case, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have selected aloe vera as the antioxidant and biocide desired by Kavouklis because KR’091 and Abu-Seida teach aloe vera is a suitable antioxidant and biocide for whitening oral care compositions.
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). In the present case, the instantly claimed range of aloe vera, 0.001-0.1% w/w, overlaps with the range of the prior art, 0.06-0.1% w/w, and so a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the composition of the second vessel (i.e., chamber 2) taught by Kavouklis, Kahwaty, Ng, Coleman and Dixit, as discussed above, to comprise aloe vera within the instantly claimed amounts.
Regarding instant claim 7 and 17, Dixit discloses the dual component whitening composition may comprise breath freshening agents such as zinc gluconate in an effective amount [0043].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the zinc gluconate of Dixit with the composition taught by Kavouklis, Kahwaty, Coleman, Dixit, KR’091 and Abu-Seida. One would have been motivated because Dixit discloses zinc gluconate provides the desirable affect of breath freshening. One would have had an expectation of success because similar to Dixit, the compositions of Kavouklis are dual component whitening formulations and so a skilled artisan would have expected zinc gluconate to also provide breath freshening when combined with the dual component formulations taught by Kavouklis, Kahwaty, Ng, Coleman, Dixit, KR’091 and Abu-Seida. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). In the present case, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have optimized the amount of zinc gluconate in compositions to discover the effective amount desired by Dixit.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the compositions of the second vessel (i.e., chamber 2) taught by Kavouklis, Kahwaty, Ng, Coleman, Dixit, KR’091 and Abu-Seida, as discussed above, to comprise zinc gluconate within the instantly claimed amounts.
Regarding instant claims 8-10 and 18-20, Kavouklis discloses the compositions may comprise peppermint flavor wherein the flavor is imparted by “substantially pure mint oil” (see [0111] on page 9; instant claims 10 and 20). Kavouklis desires active agents for plaque [0059]
Dixit relates to dual component dentifrices for whitening wherein the first component comprises a whitening agent and the second component comprises an agent that is incompatible with the whitening agent [title &abstract]. Dixit discloses antiplaque agents for the dual component whitening compositions include papain (i.e., instant claims 9 and 19) [0044]. Dixit also discloses “the composition comprises, in one or both of the first and second components, at least one surfactant, useful for example to compatibilize other ingredients and thereby provide enhanced stability, to help in cleaning the dental surface through detergency, and to provide foam upon agitation” [0050]. Suitable surfactants include sodium lauroyl sarcosinate (i.e., instant claims 8 and 18) [0052].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the sodium lauroyl sarcosinate of Dixit with the compositions taught by Kavouklis, Kahwaty, Ng, Coleman, Dixit, KR’091 and Abu-Seida. One would have been motivated because Dixit teaches sodium lauroyl sarcosinate has the desirable effects of enhanced stability, detergency for cleaning and foaming in dual component whitening compositions. One would have had an expectation of success because the whitening gels of Kavouklis do not comprise ingredients known to react with anionic surfactants, e.g., cetylpyridinium chloride.
It also would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the antiplaque agent papain of Dixit with the compositions taught by Kavouklis, Kahwaty, Ng, Coleman, Dixit, KR’091 and Abu-Seida. One would have been motivated to make this combination in order to provide additional anti-plaque action, as desired by Kavouklis. One would have had an expectation of success because Dixit discloses papain is suitable for dual component whitening compositions.
Additionally, in combining the elements discussed above one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). One would have been motivated to optimize the amount of peppermint flavor (i.e., peppermint oil) in compositions in order to provide an appropriate peppermint flavor. Similarly, one would have been motivated to optimize the amount of sodium lauroyl sarcosinate to provide appropriate stability, detergency and foaming. Finally, one would have been motivated to optimize the amount of papain to provide appropriate anti-plaque action.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the composition of the second vessel (i.e., chamber 2) taught by Kavouklis, Kahwaty, Ng, Coleman, Dixit, KR’091 and Abu-Seida, as discussed above, to comprise sodium lauroyl sarcosinate, papain and peppermint oil within the instantly claimed amounts.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612
