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 .
Applicants' arguments in the Request for Continued Examination, filed July 24, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims
Claim Rejections - 35 USC § 103 – Obviousness
Maintained Rejection
1) Claims 37-42 and 44-50 are rejected under 35 U.S.C. 103 as being unpatentable over Sase et al. (JP 2000095656) in view of Scott et al. (CA 2875230).
Sase et al. disclose compositions having excellent detergency against oily dirt in the oral cavity and yet not irritating the oral mucosa by including a non-ionic surfactant, polyhydric alcohol and reduced starch hydrolysate. The composition comprises (A) 0.2-5.0 wt.% of a non-ionic surfactant, and (B) 0.1-20 wt.% of a polyhydric alcohol. The liquid oral composition may be formulated into a mouthwash. The polyhydric alcohol used includes propylene glycol, polyethylene glycol, glycerin, sorbitol, xylitol and the like are suitably used. The polyhydric alcohol concentration in the composition ranges from 0.1 to 20% by weight. Actives include zinc chloride. Bactericides includes hinokitiol in an amount from 0.001 to 0.5% by weight. A fragrance may be added and includes an oil such as peppermint oil and spearmint oil. An example comprises 1% zinc chloride, 0.001% hinokitiol, 2% sorbitol and water. When a fragrance oil is used, an emulsion is made.
Sase et al. differ from the instant claims insofar as they do not disclose an oil-in-water emulsion.
Scott et al. disclose mouth rinse compositions formulated as stable oil-in-water emulsions (page 5, lines 18-31). Zinc ions may be added to the compositions and include zinc chloride and zinc citrate (page 16, lines 9-15). Antimicrobially effective essential oils are added and includes hinokitiol (page 16, lines 31-34). Mouthwashes include water, a surfactant, a humectant, a flavoring agent, a sweetening agent and ethanol. The oil comprises 0.05% to about 5% by weight.
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. It would have been obvious to one of ordinary skill in the art prior to the filing of the instant application to have formulated the mouthwash of Sase et al. as an oil-in-water emulsion because is a suitable form for a mouthwash formulation comprising actives including hinokitiol and zinc chloride.
Response to Arguments
The Examiner submits that mouthwashes may be in the form of oil-in-water emulsions. This is supported by Scott. Further Scott discloses the need for improvement in formulating aqueous mouth rinses containing higher levels of essentially water insoluble components such as flavor oil. Therefore, it would have been obvious to one of ordinary skill in the art to have made the compositions of Sase et al. into an emulsion because it is a suitable vehicle for mouthwashes that may contain higher amounts of flavor oils or other insoluble actives. See MPEP 2144.07. Therefore, formulating an oil-in-water emulsion with the composition of Sase is based on a predictable path identified in the prior art. In regard to the amount of oil, the amended claims recite less than 10%. Scott discloses up to 5%. Therefore, the limitation of less than 10% is met. In regards to the composition of Sase being in a neutral vehicle, the composition of Sase may also comprise cetylpyridinium chloride (CPC). Therefore, Sase does not teach away from using CPC in the disclosed composition. Further, Scott discloses that zinc salts and hinokitiol may be used in the vehicles. Therefore, it would have been obvious to have made the composition of Sase into an oil-in-water emulsions. One of ordinary skill in the art would recognize that some adjustment must be made to formulate an oil-in-water emulsion with the composition of Sase. However, this would be in the relative skill of one of ordinary skill in the art. Further, the oil phase of Scott appears to be made with the flavor oil. Sase discloses flavor oil. In order to arrive at the oil-in-water emulsion of Scott, one would have to increase the flavor oil, which Sase already discloses may be used in the compositions. In regards to the CPC, Sase discloses CPC may be used as an active. Therefore, modifying the composition of Sase would be in the relative skill of one of ordinary skill in the art. In regards to reconciling the differences, Scott specifically discloses zinc and hinokitiol may be used in their disclosed composition. Therefore, it would have also been obvious to have added zinc and hinokitiol to the composition of Scott with a reasonable expectation of success. In regards to the amount of nonionic surfactant, the amount of surfactant of Sase touch the amount of nonionic surfactant of Scott. Even if this was not the case, as stated above, Scott discloses the composition may comprise zinc and hinokitiol. Therefore, it would have been obvious to have added the zinc and hinokitiol to the composition of Scott to arrive at the composition of the instant claims.
New Rejections
2) Claims 37-40 and 44-50 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. (KR 20030069402).
Kang et al. disclose oral cavity compositions containing nano-emulsions to increase the absorption into the skin (Abstract). The nanoemulsion is an emulsion containing an oil in the inner phase and water in the outer phase, and at least one oil having a low solubility in water and at least one physiologically active substance, preferably an oral active. The composition uses lecithin as a surfactant. It can be produced by collecting the active ingredient having an oral effect. Such oral actives and oils may be contained in an amount of 2 to 30% by weight based on the total weight of the nanoemulsion. The oils usable in the present invention can be selected from oils of animal or vegetable origin, mineral oils, synthetic oils, silicone oils and mixtures thereof. Oral active ingredients can be used in combination with a blood circulation accelerator to enhance the periodontal resistance and increase the massage effect by brushing. Oral oil-soluble substances which can be contained in the particles of the nanoemulsion and include hinokichiol (hinokitiol) and the like. The composition for oral cavity includes a toothpaste and a mouthwash. A humectant may be used and includes glycerin, sorbitol solution, polyethylene glycol, propylene glycol, or the like may be mixed alone or in combination of two or more, and 10 to 60% by weight, preferably 20 to 50% by weight, based on the total weight of the composition for oral cavity is used. Sweeteners may be used and comprise 0.1 to 5% by weight of the composition. Sweeteners include saccharin sodium and xylitol. Binders are used and include carboxymethyl cellulose sodium, and xanthan gum (gelling agents). Foaming agents include surfactants and comprise 0.5 to 3% by weight of the composition. Flavors include peppermint oil meeting plant extract with antibacterial properties.
Kang et al. differ from the instant claims insofar as they do not exemplify the nanoemulsion with a zinc and hinokitiol.
However, Kang et al. do disclose using actives in mixtures (see examples and reference claims). 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. Therefore, it would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used a mixture of zinc chloride and hinokitiol in the composition of Kang et al. because mixtures are suggested by the Kang et al. and to make a composition with their known therapeutic functions.
3) Claims 37-42 and 44-50 are rejected under 35 U.S.C. 103 as being unpatentable over Sase et al. (JP 2000095656) in view of Kang et al. (KR 20030069402).
Sase et al. is discussed above and disclose a composition comprising a combination of hinokitiol and zinc salt.
Sase et al. differ from the instant claims insofar as they do not disclose an emulsion.
Kang et al. is discussed above and disclose oral cavity compositions containing nano-emulsions to increase the absorption into the skin (Abstract).
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have made the composition of Sase et al. comprising a mixture of zinc chloride and hinokitiol into a nanoemulsion motivated by the desire to increase the absorption of the composition into the oral cavity as disclosed by Kang et al.
Conclusion
Claims 37-42 and 44-50 are rejected.
Claims 51-56 are withdrawn.
No claims allowed.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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