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 January 7, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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)
Claims 1-7 and 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over Feng et al. (US 2005/0036958) in view E. Dickinson (Controlled Particle, Droplet and Bubble Formation, 1994) as evidenced by Batson (US 5,016,784)
Feng et al. disclose dental bleaching composition. The composition comprises bleaching solutions such as hydrogen peroxide. The matrix material is petrolatum (paragraph 0012). The composition may comprise solubilizing and emulsifying agents (paragraph 0036). The composition may be applied with a tray or alternative means leaving the bleaching composition in contact with the one or more teeth such that the bleaching composition may whiten the tooth (paragraph 0017). A composition is disclosed comprising a combination of 5% hydrogen peroxide, 5% water, 5% polyoxyalkylene, 74.25% white petrolatum, polyvinyl pyrrolidone, flavor and sodium saccharin (paragraph 0020). The composition comprises 74.25% white petrolatum, a hydrophobic components. Another composition comprises 20% hydrogen peroxide (50%) (meeting up to about 15%), 5% polyoxyalkylene, 74.25% white petrolatum (this meets the hydrophobic phase comprising at least 60%), flavors and sodium saccharin (paragraph 0032).
Feng et al. differ from the instant claims insofar as they do not disclose the two-dimensional density of droplets.
Dickenson discloses an emulsion is traditionally defined as an opaque, heterogeneous system of two immiscible liquid phases (‘oil’ and ‘water’) with one of the phases dispersed in the other as droplets of microscopic or colloidal size” (p. 191, Introduction, 1st paragraph). The emulsifying agent improves efficacy of the emulsification insofar as the emulsifier lowers the tension at the oil-water interface, which facilitates droplet deformation and disruption; secondly, once adsorbed at the interface, protects the newly formed droplets against immediate recoalescence (p. 210, lines 1-16). Homogenization of the phases is employed using various types of mixture, where, as Dickerson teaches, “Droplet diameters down to about 5 µm can be produced” (p. 204, sec. 7.2.4, lines 1-5).
The compositions of Feng et al. comprise substantially the same components; water, hydrogen peroxide and petrolatum, in substantially the same amounts as recited by the instant claims. The polyoxyalkylene would act as an emulsifier that would uniformly distribute the aqueous droplets though the hydrophobic phase creating the two-dimensional density of the droplets, mean residual peroxide intensity and bleaching efficacy. Therefore one of ordinary skill in the art would have reasonably expected to produce an effective (stable) emulsion where the droplets are small and resist recoalescence into larger droplets. Feng et al. further discloses that the compositions are homogeneous mixtures. Therefore, one of ordinary skill in the art would have expected an even distribution of the aqueous droplets throughout the petrolatum.
Accordingly, it would have been obvious for the droplets to have the two dimensional density of droplets as recited by the instant claims.
Water is present in the compositions, which is not miscible in petrolatum. Therefore it is reasonable to conclude that the compositions are multiphase compositions since the water will not combine with petrolatum. The compositions also comprise polyoxyalkylene, which is a surfactant. Therefore one would reasonably conclude that the water phase would form droplets dispersed though the hydrophobic phase.
In regards to the hydrophobic phase having a cone penetration value of about 300 to about 100 measured according to ASTM method D937-07; having a drop melting point ranging from about 40C to about 80C measured by ASTM method D127-08, and the cross section of the drop in the two-dimensional plane being greater than about 10000 square microns; the recited cross sectional area, the two-dimensional density of droplets, the standard deviation of the peroxide intensity, and the bleaching effect of the invention; the hydrophobic phase is petrolatum. According to Baston, petrolatum, also known as white petroleum, has a cone penetration consistency of 100 to 300 as measured by ASTM D937 (see Batson col. 3, lines 55-59), which fall within the claimed range of about 50 to about 500.
In regard to claims 6 and 7, the compositions of Feng et al. use petrolatum. Therefore it is reasonable to conclude that the compositions of Feng et al. would have the same drop melting point.
Response to Arguments
The Examiner submits that in regards to the declaration, the declaration was considered and was previously discussed in the Office Action mailed March 27, 2025. However, as evidenced by David et al., “An emulsion is a mixture of two or more liquids that are usually immiscible but, under specific transforming processes, will adopt a macroscopic homogeneous aspect and a microscopic heterogeneous one. In an emulsion, one liquid is dispersed in the other”. Therefore, although Feng discloses a homogeneous mixture, this does not teach away from an emulsion. Feng discloses mixing an aqueous composition with petrolatum, a hydrophobic component. Petrolatum is not miscible with water. Feng also discloses that emulsifiers may be used. Therefore, one would not have to modify the composition of Feng to be a water-in-oil emulsion because it is suggested to make or because it is reasonable to conclude that it is a water-in-oil emulsion. One would conclude this because emulsifiers may be used and because petrolatum and water are not miscible, this would lead to an water-in-oil emulsion. Example 2 comprises 5% hydrogen peroxide, 5% water, 5% polyoxyalkylene, 83.75% white petrolatum, flavor and sodium saccharin. Although the polyoxyalkylene is a tackifying agent, one would reasonably conclude that this would not inhibit the formation of a semi-solid emulsion because it would not make the aqueous phase miscible with the petrolatum. One would reasonably conclude that even liquid droplets could exist in a semi-solid emulsion. Further, as stated above, emulsifiers may be added to the compositions. Therefore, the emulsifier would lead to an emulsion when an aqueous mixture and petrolatum are combined.
2) Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Feng et al. (US 2005/0036958) in view of E. Dickinson (Controlled Particle, Droplet and Bubble Formation, 1994), as evidenced by Batson (US 5,016,784), in further view of Quan et al. (EP 1696866).
Feng et al. in view of Dickinson is discussed above and differs from the instant claims insofar as it does not disclose a strip but does disclose using a tray or an alternative means leaving the bleaching composition in contact with the one or more teeth such that the bleaching composition may whiten the tooth.
Quan et al disclose delivering bleaching agents to the teeth on a strip. The strip serves as a protective barrier for the bleach. It prevents leaching and/or erosion of the second layer by for example, the wearer's tongue, lips, and saliva. This allows the active in the second layer to act upon the hard surfaces of the oral cavity for an extended period of time, from several minutes to several hours.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used a strip to deliver the compositions of Feng et al. in view of Dickinson to the teeth because the strip may be use as a protective barrier for the bleach and prevents leaching and/or erosion of the bleaching composition by for example, the wearer's tongue, lips, and saliva as disclosed by Quan et al.
Response to Arguments
The Examiner submits that Quan et al. cure the deficiencies of Feng in view of Dickinson by disclosing why one of ordinary skill in the art would use a strip with the composition of the Feng in view of Dickinson. Therefore the rejection is maintained.
Conclusion
Claims 1-7 and 9-19 are rejected.
Claim 20 is withdrawn.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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