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, 3-15, 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dolan et al., (US 2018/0168958) in view of Rege et al., (US 2018/0168956).
Dolan et al. teaches dentifrice compositions “containing an abrasive and a stannous ion source”, “where the extractable stannous ions after 30 days at 40°C. is greater than about 75% of the initial extractable stannous ion concentration” (Abstract). The stannous ion source, which can vary, includes stannous salts such as “stannous fluoride”, which “can be present in an amount of from about 0.05% to about 7%” (p. 8, para. [0079]).
Concerning claim 22, Dolan teaches at toothpaste insofar as “the terms ‘toothpaste’ and ‘dentifrice’ can be used interchangeably” (p. 2, para. [0027]).
The compositions are also taught to comprise “a zinc salt” (p. 5, para. [0057]), e.g. “zinc citrate” (p. 10, para. [0092]), “pyrophosphates”, “tripolyphosphates” (Id.), e.g. “calcium pyrophosphate” (clm.11), “tetrapolyphosphate” (clm. 11-14; p. 8, para. [0085]), which may be present “from about 1% to about 35%” (Id. para. [0087];clm. 12), and “a thickening agent” such as “carrageenan” and “hydroxyethyl cellulose”, where thickening agents “can be used in an amount from about 0.1% to about 15%, by weight of the oral composition” (p. 9, para. [0098]); “buffering agents”, which can include “citric acid, sodium citrate” and can be present “from about 0.1% to about 30% . . . by weight of the composition” (p. 9, para. [0091]; claim 17).
Accordingly, it would have been obvious to provide carrageenan and hydroxyethyl cellulose within the clamed range of 0.1 to 0.5, as per claims 18, 20-21.
The prior art teaches a specific embodiment of an aqueous dentifrice comprising 1.00% zinc lactate dihydrate, 0.454% stannous fluoride (first stannous source; clm.9-10), and a thickener system comprising 0.720% Hydroxyethyl Cellulose 250M 420NF and 1.080% carrageenan (p. 11, para. [0109], Example A:
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Here, the ratio of hydroxyethyl cellulose to carrageenan, is 0.66, which falls within the claimed ratio of 0.5 to 2, as per claim 19.
Since the prior art formulation combines hydroxyethyl cellulose with carrageenan, the claimed property of allowing the composition to still be dispensed after 8 weeks of accelerated aging relative to a control formulation which contains 0.2% xanthan gum 0.2% carboxymethyl cellulose, would have been inherent. Note: Applicant hypothesized, “it is hypothesized that this progressive thickening may be due to the xanthan and carboxymethyl cellulose gums that are anionic nature, and can bind with high quantities of cationic metal ion species present in the formulas, i.e. the stannous and zinc cations. Accordingly, the inclusion of Hydroxyethylcellulose (HEC), a non-ionic gum is believed to possibly help limit this interaction” (Specification at p. 25, para. [0045]).
Dolan et al. does not teach zinc oxide, as a source of zinc, or stannous pyrophosphate as a source of stannous.
Rege et al. teaches “oral care compositions comprising a zinc source comprising zinc oxide and zinc citrate; a stannous source comprising stannous pyrophosphate; a fluoride source comprising sodium fluoride; and an organic buffer” (Abstract).
Rege et al. further describes a test formulation comprising “1% stannous pyrophosphate, 1.0% zinc oxide, 0.5% zinc citrate, 2% tetrasodium pyrophosphate and 2.1% citrate buffer system (an aqueous buffer system comprising 0.6% citric acid and 1.5% tri-sodium citrate)”, wherein “[t]here is improved zinc uptake in bovine block tests when compared to formulations which contain SnF and zinc lactate (but not ZnO and Zn Citrate)”” (p. 1, para. [0005]).
Here, the ratio of zinc oxide to zinc citrate is 2, falling within the claimed range of 1.5 to 5.4, as per claim 4. The artisan would have reasonably expected this ratio to suffice with the combination of zinc oxide to zinc lactate, as per claim 7. Note: zinc lactate of Dolan et al. can have the same concentration of zinc citrate, i.e. it can be present “from about 0.001% to about 1.5%, by weight of the oral composition” (see Dolan et al. at p. 11, para. [0106]).
Rege et al. also identifies suitable polyphosphates such as “sodium tripolyphosphate” (p. 1, para. [0031]), “tetrapotassium pyrophosphate” in amounts of 1-20% (p. 2,para. [0032]), as per claims 11-15.
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add stannous pyrophosphate, zinc oxide, zinc citrate shown in Rege et al., to the compositions of Dolan et al. for the advantage of improved zinc uptake as taught by Rege 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, 3-15, 17-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,154,468 in view of Baig et al (US 2016/0324738 A1, cited in IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other. The issued claims recite all of the features instantly recited for the oral care composition, namely zinc citrate, zinc oxide, stannous pyrophosphate, fluoride, sodium tripolyphosphate, citrate buffer system, except for stannous fluoride and a gum system comprising hydroxyethyl cellulose and carrageenan. The instant claims require a gum system comprising hydroxyethyl cellulose and carrageenan. Further, the instant claims 1 and 19-21 limit the amounts of the gum system, and components thereof.
However, Baig taught hydroxyethyl cellulose and carrageenan as thickening agents (e.g., gum system), each in amounts from about 0.1 % to about 15 % [0061] as well as a mixtures of stannous ion sources including “stannous fluoride” and “stannous pyrophosphate” (p. 3, para. [0035]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art to include mixtures of stannous ion sources, hydroxyethyl cellulose and carrageenan in amounts of about 0.1 % to about 15.0 % within the copending and issued formulations. An ordinarily skilled artisan would have been motivated to formulate the oral care composition, as taught by Baig.
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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