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 . Claims included in the prosecution are claims 1-15 and 18-21.
Reason for Withdrawal
Applicant’s arguments, see Pre-Appeal Brief Conference Request, filed 06/11/206, with respect to the rejection(s) of claim(s) 1-15 and 18-21 under 103 obviousness have been fully considered and are persuasive. Applicant had argued that the term mouthwash in the preamble is a structural limitation to distinguish from low-viscosity liquid dentifrices. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made.
Claim Rejections - 35 USC § 103
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.
1. Claims 1, 5, 6, 11-13, 15 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Miehlich et al. (WO 2016/078831 A1, May 26, 2016) (hereinafter Miehlich).
Miehlich discloses an oral and dental care and cleaning composition comprising, based on its weight, a) at least one compound falling under the INCI name polyquaternium, b) from 0.01 to 10% by weight of amphoteric surfactant(s), and c) 500 to 1600 ppm of fluoride. The oral and dental care and cleaning composition can be present in the form of a mouthwash used to rinse the oral cavity (page 1 of translation). Suitable fluoride-providing agents include amine fluorides such as olaflur (page 3 of translation). As a further ingredient, the composition may comprise further surfactant(s), in particular anionic surfactants. The oral and dental care and cleaning composition contains 0.5 to 5% by weight of surfactant(s). Suitable anionic surfactants include acyl glutamates (page 4 of translation). The compound falling under the INCI name polyquaternium is used for reducing the hypersensitivity of teeth (page 7 of translation). The mouthwash may comprise 96.289% water (Example 2, formulation A).
The prior art discloses a mouthwash (page 1 of translation) comprising amine fluoride (page 3 of translation) and acyl glutamate (page 4 of translation). Together these would provide a composition as claimed instantly.
The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
In regards to instant claims 1, 12, and 13 reciting 0.5 to 1.5%, 0.85% to 0.95%, and 0.8 to 1.2% amine fluoride, respectively, Miehlich teaches 500 to 1600 ppm of fluoride and wherein the fluoride source may be olaflur. An amount of 0.9% olaflur contains 684 ppm fluoride. Thus, Miehlich teaches the claimed amount of olaflur. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
In regards to instant claim 6 reciting 0.12% to 0.16% acyl glutamate, Miehlich teaches 0.5 to 5% further surfactant(s). Thus, the claimed amount of acyl glutamate would have been obvious when there are additional further surfactants to acyl glutmate and the total amount of further surfactant(s) is within the range disclosed by Miehlich. For example, a composition comprising 0.15% acyl glutamate and 0.35% of another surfactant for a total amount of 0.5% further surfactant(s) would have been obvious.
In regards to instant claims 15, 19 and 20, Miehich does not teach wherein the composition requires sodium lauryl sulfate as the anionic surfactant or another anionic surfactant other than the acyl glutamate and Miehich does not teach wherein the composition requires cellulosic polymers, gum polymers, or polyacrylate polymers. Therefore, a composition free of sodium lauryl sulfate, anionic surfactants other than the acyl glutamate, cellulosic polymers, gum polymers, and polyacrylate polymers would have been obvious.
2. Claims 2-4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Miehlich et al. (WO 2016/078831 A1, May 26, 2016) (hereinafter Miehlich) in view of Das et al. (US 2020/0206113, Jul. 2, 2020) (hereinafter Das).
The teachings of Miehlich are discussed above. Miehlich does not teach wherein the composition comprises sodium cocoyl glutamate.
However, Das discloses an oral care comprising an anionic surfactant. The anionic surfactant may include a C-6-18 fatty acid glutamate (abstract). The C6-C18 fatty acid glutamate may include a cocoyl glutamate salt. The cocoyl glutamate salt may be sodium cocoyl glutamate (¶ [0006]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Miehlich discloses wherein the composition comprises further surfactant(s), in particular anionic surfactants. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated sodium cocoyl glutamate into the composition of Miehlich since it is a known and effective anionic surfactant for oral care composition as taught by Das.
3. Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Miehlich et al. (WO 2016/078831 A1, May 26, 2016) (hereinafter Miehlich) in view of Hug et al. (US 2015/0366768, Dec. 24, 2015) (hereinafter Hug) and Hinrichs et al. (US 2020/0268624, Aug. 27, 2020) (hereinafter Hinrichs).
The teachings of Miehlich are discussed above. Miehlich does not teach wherein the composition comprises an amine base.
However, Hug discloses an oral care composition comprising an amine fluoride (abstract). The amine fluoride could be made in situ, for examples using an amine base and fluoride-containing component which can react to form an amine fluoride) (¶ [0086]).
Hinrichs discloses an oral care composition (abstract). The composition may comprise an amine base (¶ [0046]). An amine base is the base portion of amine fluoride – i.e., the compound N,N,N’-tris(2-hydroxyethyl)-N’octadecyl-1,3-diaminopropane (i.e., N’-octadecyltrimethylendiamine-N,N,N’-tris(2-ethanol) (¶ [0090]).
Miehlich discloses wherein the composition comprises an amine fluoride. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated N,N,N’-tris(2-hydroxyethyl)-N’octadecyl-1,3-diaminopropane (i.e., N’-octadecyltrimethylendiamine-N,N,N’-tris(2-ethanol) into the composition of Miehlich since an amine fluoride can be provided by reacting an amine base with a fluoride-containing component as taught by Hug and N,N,N’-tris(2-hydroxyethyl)-N’octadecyl-1,3-diaminopropane (i.e., N’-octadecyltrimethylendiamine-N,N,N’-tris(2-ethanol) is a known and effective amine base of an amine fluoride as taught by Hinrichs.
Response to Arguments
Applicant argues that the specification demonstrates that the recited combination of acyl glutamate and amine fluoride achieves unexpected superior results that rebut any prima facie case of obviousness.
The Examiner does not find Applicant’s argument to be persuasive. Applicant must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. See MPEP 716.02(e). In the instant case, Applicant has not compared the claimed invention with the closest subject matter. Applicant compared the claimed invention with Formulation B containing amine fluoride and PEG-40 hydrogenated castor oil. Formulation B is not the closest subject matter. As discussed in the previous office action, Baig et al. (US 2021/0196581, Jul. 1, 2021) disclose a composition comprising fluoride and sodium cocoyl glutamate (claim 11), wherein the fluoride may be amine fluoride (claim 14). Baig et al. is the closest subject matter since Baig et al. teaches sodium cocoyl glutamate with fluoride, which is closer to the claimed subject matter of sodium cocoyl glutamate with amine fluoride than a formulation comprising amine fluoride and a PEG surfactant, wherein the PEG surfactant does not share any functional groups similar to sodium cocoyl glutamate. Applicant has not shown wherein using amine fluoride in combination with sodium cocoyl glutamate in a mouthwash composition is unexpected over other compositional forms. As such, since Applicant has not compared the claimed subject matter with the closest prior art, Applicant has not effectively rebutted a prima facie case of obviousness.
Conclusion
Claims 1-15 and 18-21 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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