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.
Applicants' arguments, filed 02/23/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
1. Claims 1, 5, 6, 11-13, 15 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Miehich et al. (EP 2813214 A1, Dec. 17, 2014) (hereinafter Miehich).
Miehich discloses a low viscosity liquid dentifrice comprising amine fluoride, sorbitol, and a medium weight polyethylene glycol of narrow molecular weight distribution (page 2, first paragraph). The composition has a viscosity of from 10,000 to at most 70,000 mPa·s and comprises 1 to 2.5% by weight of at least one amine fluoride (page 2, second paragraph). Suitable amine fluorides include olaflur (page 3, second paragraph). The composition may comprise surfactants in an amount of 0.1-5% by weight (page 5, penultimate paragraph). Suitable surfactants include acyl glutamates (page 6, second paragraph). The composition promotes plaque reduction and fluoride deposition (page 1, first paragraph). The composition may comprise water (page 3, ninth paragraph).
The prior art discloses a composition comprising amine fluoride (page 2, first paragraph) and acyl glutamate (page 6, second paragraph). 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 claim 1 reciting a mouthwash, this is merely a recitation of the intended use of the composition. Since the composition of Miehich is a low viscosity liquid dentifrice, it is capable of being swished in the oral cavity and used as a mouthwash.
In regards to instant claim 12 reciting 0.85 to 0.95% amine fluoride, Miehich discloses 1% amine fluoride. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I). Accordingly, since 0.95% is so close to 1%, one of ordinary skill in the art would have expected them to have the same properties, thus making 0.95% obvious.
In regards to instant claims 15, 19 and 20, Miehich does not teach wherein the composition requires sodium lauryl sulfate, an anionic surfactant other than the acyl glutamate, cellulosic polymers, gum polymers, or polyacrylate polymers. The composition of Miehich only requires an amine fluoride, sorbitol, and a medium weight polyethylene glycol of narrow molecular weight distribution (see page 2, first paragraph of Miehich). 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 Miehich et al. (EP 2813214 A1, Dec. 17, 2014) (hereinafter Miehich) in view of Das et al. (US 2020/0206113, Jul. 2, 2020) (hereinafter Das).
The teachings of Miehich are discussed above. Miehich 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. Miehich discloses wherein the composition comprises a surfactant. 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 Miehich since it is a known and effective 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 Miehich et al. (EP 2813214 A1, Dec. 17, 2014) (hereinafter Miehich) 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 Miehich are discussed above. Miehich 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]).
Miehich 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 Miehich 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.
4. Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Miehich et al. (EP 2813214 A1, Dec. 17, 2014) (hereinafter Miehich) in view of Gallis et al. (US 2010/0189663, Jul. 29, 2010) (hereinafter Gallis).
The teachings of Miehich are discussed above. Miehich does not teach wherein the composition comprises 70% to 99% by weight water.
However, Gallis discloses a mouth rinse (abstract). The mouth rinse exhibits a viscosity of at most 10,000 cps (10,000 mPa·s) (¶ [0009]). Since mouth rinse compositions are liquid in nature, and thus exhibit a viscosity of at most 10,000 cps (as noted above), the starting point for such compositions are the base solvents. Typically, water can be the main ingredient to permit the necessary liquid form as well as for cost reasons. The base solvent may constitute from 75-99.99% by weight of the overall formulation (¶ [0013]).
Accordingly, since the composition of Miehich comprises water and may have a viscosity of 10,000 mPa·s, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated 75-99.99% by weight water into the composition of Miehich since this is a known and effective amount of water to formulate an oral composition with a viscosity of 10,000 mPa·s as taught by Gallis.
Response to Arguments
Applicant argues that nothing in Miehih indicates that the dentifrices of Miehich could be swished in the mouth.
The Examiner does not find Applicant’s argument to be persuasive. Miehich discloses a liquid dentifrice. Liquids can be swished in the mouth. As such, Applicant’s argument is unpersuasive.
Applicant argues that if the dentifrices of Miehich were liquids capable of being used as mouthwashes they would not be applied to a toothbrush head, they would be applied to the oral cavity directly.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, Miehich discloses wherein the liquid dentifrice may have a viscosity of 10,000 mPa·s. Gallis discloses wherein mouth rinses may have a viscosity of 10,000 cps (10,000 mPa·s) (¶ [0013]). As such, the liquid dentifrice of Miehich may be used as a mouthwash since it may have the same viscosity as a mouthwash. Thus, Applicant’s argument is unpersuasive.
Applicant argues that Miehich’s composition contains polishing agents at 5-50% by weight, which are characteristic of toothpastes, not mouthwashes.
The Examiner does not find Applicant’s argument to be persuasive. As evidenced by Lee et al. (US 2002/0086039, Jul. 4, 2002), the antimicrobial and abrasive effects of bioactive glass are particularly useful in mouthwash and mouth rinse products to reduce bacteria and to remove stains (¶ [0341]). Thus, mouthwashes may contain polishing agents to remove stains. As such, Applicant’s argument is unpersuasive.
Applicant argues that Miehich discloses a list of preferred surfactants that do not include acyl glutamates.
The Examiner does not find Applicant’s argument to be persuasive. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See MPEP 2123(I). Thus, Miechich not disclosing acyl glutamate as a preferred surfactant does not make acyl glutamate nonobvious. As such, Applicant’s argument is unpersuasive.
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. 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 and the rejections are maintained.
Applicant argues that Das, Hug, and Hinrichs do not cure the deficiencies of Miehich as discussed above.
The Examiner submits that arguments regarding Miehic have been addressed above and are unpersuasive. Therefore, all the rejections are maintained.
Conclusion
Claims 1-15 and 18-21 are rejected.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TRACY LIU/Primary Examiner, Art Unit 1614