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, filed December 31, 2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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)
Claims 1-10 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Jiao et al. (US 2016/0095801) in view of Prosise et al. (WO 2011130009) in further view of Ahn et al. (KR 0163502).
Jiao et al. disclose multi-component dental whitening compositions comprising a bleaching agent and an activating agent. The tooth whitening compositions of the present invention comprises a two-component system presented in dual-barrel syringes. The first component active bleaching agent, a peroxide, may be present at above about 15% by weight, preferably from about 15% by weight to about 40% by weight peroxide. The peroxide includes hydrogen peroxide, carbamide peroxide and urea peroxide (paragraph 0046). Second component is an activator gel . The first and second component are in a ratio of 1:1 to 5:1 first to second component (paragraph 0047). The activating agents include sodium hydroxide, potassium hydroxide, sodium carbonate and bicarbonate (paragraph 0041). When the two components are mixed, the resulting pH ranges from 7.0 to 8.5 (paragraph 0041). This would encompass the limitation of instant claim 5 because the pH is changed once the two components are mixed. A kit includes a dual compartment syringe comprising bleaching gel in a first part and activator gel in a second part (paragraph 0020). Surfactants are used and include polyoxyethylene/polyoxypropylene block copolymer ranging from 1% to about 8% (paragraph 0043). Thickeners are used and include polyvinyl pyrrolidone ranting from 0.1% to about 35%. Both components comprise a thickening agent (see Tables). Water comprises 50% of the activator gel and 26% of the bleaching gel (component 1) (Table 3 and 1). Glycerin comprises 17% of the bleaching gel (Table 1).
Jiao et al. differ from the instant claims insofar as it does not disclose that the polyvinyl pyrrolidone is crosslinked.
Prosise et al. disclose oral care compositions containing an oral care ingredient and a thickening agent, wherein the thickening agent comprises a strongly swellable, lightly to moderately crosslinked polyvinyl pyrrolidone. The polyvinyl pyrrolidone thickening agent is characterized by an aqueous gel volume of about 15 to 150 ml/g and a Brookfield viscosity of at least 10,000 cps for a 5% aqueous solution at 25° C. The PVP is commercially available as FLEXITHIX®, thickener disclosed by the instant specification and therefore meets the limitations of the instant claims. The amount of thickening agent can vary depending upon the consistency and the desired thickness of the composition. In accordance with certain aspects of the present invention, the thickening agent may be used in amounts from about 0.5 to about 10% (paragraph 0014). The compositions are produced as stable compositions.
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 used crosslinked polyvinyl pyrrolidone in the compositions of Jiao et al. motivated by the desire to use a PVP that is suitable for use with different oral care actives and lead to stable oral care compositions.
Jiao et al. in view of Prosise et al. differs from the instant claims insofar as it does not disclose the pH of the alkaline material.
Ahn et al. disclose stable whitening liquid toothpaste compositions. The compositions comprise a peroxide containing component and a basic liquid toothpaste having a pH of 7.5 to 10.5. since the basic liquid toothpaste having a pH of 7.5 to 10.5 is used simultaneously, it can promote the decomposition of peroxide in the oral cavity and exhibit the maximum whitening effect for a short brushing time, as well as the cleaning effect and tooth decay expected in a conventional toothpaste. Preventive effects can also be expected. That is, the basic liquid toothpaste is adjusted to a pH of 7.5 to 10.5 by using a pH adjuster in a conventional liquid toothpaste, and it is considered that the pH of the peroxide is changed to weak alkali when used to promote the decomposition of the peroxide, thereby increasing the whitening effect. pH adjusting agents include strong alkaline substances such as sodium hydroxide (page 3).
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have made the alkaline component of Jiao et al. in view of Prosise et al. a pH of at least 10 because when mixed with the peroxide containing part, it would raise the pH of the peroxide part to promote the decomposition of peroxide in the oral cavity and would exhibit the maximum whitening effect for a short brushing time
In regards to a pH of at least 12, the pH of each part would control the final pH when mixed. It would have taken no more than the relative skill of one of ordinary skill in the art to have adjusted the pH of each component to obtain the desired pH when mixed. See MPEP 2144.05.
In regard to the type of kit, the two component compositions of Jiao et al. comprise the amounts of peroxide recited by the instant claims and therefore would be suitable for home or office use. Therefore, the compositions of the references meet the limitation of the claim.
In regards to the mixing tip, one would have been obvious to use mixing tip to deliver the parts at the same time with the desired pH when using a dual barrel syringe.
Response to Arguments
The Examiner submits, that in regards to the limitation of the hydrogen peroxide being stable for 12 months at 23 degrees C, Jiao discloses that the hydrogen peroxide was present at 94.7% at 12 months at a temperature of 23 degrees C (TABLE 7). In regards to the viscosity, the viscosity appeared to be maintained at room temperature for 12 months (TABLE 10). In regards to Jiao not disclosing long term stability, Jiao discloses long term stability in the Tables, see TABLEs 7 and 10. In regards to Prosise and Ahn, the references disclose crosslinked polyvinyl pyrrolidone that are suitable for orally acceptable gels. PVP is also used to stabilize peroxide. Therefore, one of ordinary skill in the art would reasonably conclude that adding PVP to the composition of Jiao would not significantly affect the stability of the peroxide or the viscosity. Jiao recognizes the technical problem as shown in the tables. Furthermore, Prosise et al. disclose using crosslinked PVP to produce a stable composition. Therefore, one would use a crosslinked polyvinyl pyrrolidone in the composition of Jiao because it is a suitable PVP thickening agent for oral care compositions with a stabilizing effect. Both Jiao and Prosise disclose stability and ways to stabilize the disclosed compositions. Jiao meet the stability limitations of the instant claims as well as discloses PVP may be used as the thickening agent. Prosise discloses crosslinked PVP helps with the stability of the oral care composition disclosed therein. Therefore, the stability of the composition is predictable based on the teachings of Jiao and Prosise.
Conclusion
Claims 1-10 and 12-15 are rejected.
No claims allowed.
THIS ACTION IS MADE FINAL. 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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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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