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 .
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-11, 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moro et al., (US 2006/0073174).
Moro et al. teaches “A thin, flexible, bilayer or multi-layer film which when applied to a moist surface of a body tissue adheres and delivers an active agent, a pharmaceutical compound, nutraceutical, flavor or other substance to the underlying surface and/or body cavity and erodes at a predetermined rate” (Abstract).
Moro et al. further teaches, “Another object of the present invention is to provide a convenient, user-friendly, erodible, layered device that adheres to moist teeth surfaces and delivers a tooth-whitening agent to the underlying stained surfaces” (p. 1, para. [0008]; addresses claim 15), wherein suitable whitening agents include “but are not limited to peroxides . . . persulfates . . . alone or in combination thereof”, where peroxides include “hydrogen peroxide” . . . “and the persulfates are oxones” (p. 5, para. [0049]; clm. 18). Further, “[t]he concentration of the whitening agent typically varies from about 0.1% to about 30% by weight of the total layered device, or alternatively from about 0.5% to about 20% by weight” (p. 5, para. [0050]), as per claims 7 and 17.
Note that the suitable whitening agents include Oxones, which, in fact, represents a triple salt 2KHSO5·KHSO4·K2SO4 (i.e. potassium peroxymonosulfate, potassium hydrogen sulfate, potassium sulfate), as per claims 4-5 (see Technological Background below). Concerning claim 19, the molecular weight of oxone, the triple salt, is 614.7 g/mol. Since there are two moles of KHSO5 (potassium peroxymonosulfate) per oxone triple salt, at 152.2g/mol each, there is present at total of 304.4 g/mol of the potassium peroxymonosulfate, which amounts of 49.52% of the triple salt.
Since the film comprises at least one whitening agent it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to select potassium peroxymonosulfate, to the exclusion of hydrogen peroxide, as per claim 6.
The prior art “film” is hydratable and adhesive insofar as the prior art teaches, “The device initially adheres to moist tooth surface due to the hydration and partial solubilization of the water-soluble polymer layer. The whitening agent that is dispersed throughout this polymeric layer is then activated as it comes in contact with saliva and is released to the underlying surface” (p. 4, para. [0043]).
“The polymeric coating layer that adheres to the tooth enamel is composed of one or more adhesive polymers, an appropriate whitening agent and a plasticizer. This coating may also contain an antioxidant, a preservative, a flavor and a taste-masking compound” (p. 4, para. [0045]), where adhesive polymers include “hydroxyethyl cellulose . . . polyvinyl pyrrolidone . . . polyethylene glycol . . . alone or in combination thereof. In one aspect, the polymers are hydroxyethyl cellulose and polyvinyl pyrrolidone since they exhibit rapid and effective adhesion to enamel when in contact with a moist tooth surface” (p. 4, para. [0046]), as per claims 1 and 10.
The compositions further comprise a buffering agent insofar as they comprise polyphosphates such as “pyrophosphates” i.e. “sodium acid pyrophosphate and potassium pyrophosphate” (p. 4, para. [0049]), which may be present “from about 0.1% to about 30% by weight of the total layered device” (Id. para. [0050]; see also p. 10, Example 29 at [0157]), as per claim 9.
The prior art teaches a specific embodiment of “[a] 29.87 gram batch of active adhesive solution” including 4.37 grams hydroxyethyl cellulose (Natrosol 250L NF; Hercules), 1.80 grams PVP (Povidone P-1416; Spectrum), 0.09 grams sodium benzoate (Spectrum), 0.09 grams propylene glycol (Spectrum), 2.70 grams carbamide peroxide (Spectrum), and 20.82 grams deionized and 0.22 µ-filtered water.” (p. 12, Example 2, para. [0131]).
Here, the hydroxyethyl cellulose and PVP make-up about 70% of the film, based on the dry weight of the film, as per claims 2-3, 16.
Regarding claims 8 and 10, Moro et al. teaches, “The adhesive layer is then formed directly on top of the backing layer and the resulting bilayered product is further processed as outlined above” (p. 6, para. [0062]). Accordingly, the prior art teaches a single-layer adhesive film disposed in a backing layer.
Regarding claims 13-14, the backing layer is taught to be comprised of “coated paper, polyethylene, polypropylene, mylar and the like” (p. 2, para. [0015]).
Regarding claim 15, the prior art teaches an embodiment where the “backing layer was doctor-bladed at a setting of 1.10 mm setting and the adhesive was doctor-bladed as a setting of 1.90 mm” (p. 12, Example 57, para. [0188]), which provides a total thickness of 3.0 mm for the combination strip.
Regarding claims, 11, 19-20, the erosion rate of the device controls the time the device is affixed to a tooth, which “can be regulated from one half hour to several hours, depending upon the desired therapeutic or cosmetic application” (Abstract).
The prior art is not anticipatory insofar as it does not require an inorganic salt of peroxymonosulfate (persulfate).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to replace the carbamide peroxide of Example 2 with or add an inorganic salt of peroxymonosulfate based on the teaching of the prior art to select persulfates i.e. oxones, as the whitening agent alone or in combination with another whitening agents within the claimed range of 0.1% to about 10% by weight of the total layered device, as taught by Moro et al.
2) Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moro et al., (US 2006/0073174) as applied to claim 12 above, and further in view of De Vreese et al., (EP 2700396).
Moro et al., which is taught above, differs from claim 12 insofar as it does not teach wherein a pH of about 5 to 9.
De Vreese et al. teaches a strip for delivery of oral care compositions including Oxone (potassium peroxymonosulfate) (Ti. and p. 3, para. [0029]), wherein the “pH of a teeth whitening composition is in the range of 6.2 to 7.7, and is preferably 6.5” (p. 11, para. [0124]).
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
Accordingly, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to provide a pH within the claimed range of 5 to 9 for the oral care compositions of Moro et al. based on the art recognized suitability of a pH from 6.2 to 7.7, preferably 6.5, for oral care whitening formulations in a dental strip, as taught by De Vreese et al.
Nonstatutory Obvious-type Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,214,063. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a tooth whitening strip comprising a hydratable adhesive film comprising water-soluble or water swellable polymers, i.e., polyvinylpyrrolidone, an inorganic salt of peroxymonosulfate dispersed in the hydratable adhesive film, and a buffering agent. Water in the instant claims would have been obvious in view of the requirements of a buffering agent and a pH of 5 to 9.
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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