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 . Claims included in the prosecution are claims 1-20.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
1. Claims 1-9, 12-15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Georgiades (US 2003/0211052, Nov. 13, 2003).
Georgiades discloses a tooth-whitening composition comprising at least one dicarboxylic acid, such as oxalic acid, malonic acid, tartaric acid, and/or a salt thereof as a whitening agent. The composition can be provided in a variety of forms, including a toothpaste (i.e., dentifrice) (abstract). The whitening agent is present in said composition at a tooth-whitening effective concentration (claim 4). The tooth-whitening effective concentration is less than about 5% (claim 6). The pH of the composition may be about 4.2 (i.e., meeting about 4.5) (claim 8). The composition may include additional ingredients. Such additional ingredients include, e.g., fluorine-providing compounds, anticalculus agents, abrasives, thickeners, and humectants. The ingredients are combined in a hydrous or anhydrous vehicle (¶ [0038]). Suitable fluorine-providing compounds include sodium monofluorophosphate, stannous fluoride, and mixtures thereof (¶ [0060]). The amount of fluorine-providing compound may be present in an amount by weight of up to about 1.2% (¶ [0061]). Suitable anticalculus agents include polyphosphates and pyrophosphates. Zinc salts are also suitable anticalculus agents (¶ [0062]). Suitable abrasives include calcium carbonate (¶ [0039]). Table 1 discloses a toothpaste comprising sodium monofluorophosphate, oxalic acid, xanthan gum (i.e., claimed polysaccharide thickening agent), glycerin (i.e., claimed humectant), 36.1413% water, no polyphosphate, and no zinc.
Georgiades does not anticipate the instant claims insofar as not explicitly disclosing wherein the composition is free of carboxymethyl cellulose.
However, the abstract, the field of invention, and claim 1 of Georgiades do not disclose wherein the composition requires the presence of carboxymethyl cellulose. Therefore, it would have been obvious to one of ordinary skill in the art to have excluded carboxymethyl cellulose from the composition.
In regards to instant claim 1 reciting wherein the oral care composition results in a calcium loss in dentin and/or enamel of less than 50 ppm, the composition of Georgiades comprises substantially the same components as the claimed composition (e.g., oxalic acid less than about 5%, sodium monoflorophosphate, and free of carboxymethyl cellulose) and has substantially the same pH as the claimed composition (e.g., about 4.2 (meeting about 4.5)); therefore, one of ordinary skill in the art would reasonably expect the composition of Georgiades to result in a calcium loss in dentin and/or enamel of less than 50 ppm like the claimed invention.
2. Claims 8, 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Georgiades (US 2003/0211052, Nov. 13, 2003) in view of Porter et al. (US 2013/0017238, Jan. 17, 2013) (hereinafter Porter).
The teachings of Georgiades are discussed above. Georgiades does not teach wherein the composition comprises zinc oxide, precipitated silica, and amino acid.
However, Porter discloses an oral care composition comprising zinc oxide (abstract). Zinc oxide exhibits a dual function, namely occlusion of dentin tubules and providing and anti-plaque/anticalculus effect (¶ [0040]). The composition may comprise precipitated silica as an abrasive (¶ [0055]). The composition may optionally comprise a nutrient. Suitable nutrients include amino acids such as methionine (¶ [0081]).
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. Georgiades discloses wherein the composition may comprise a zinc salt as the anticalculus agent. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated zinc oxide into the composition of Georgiades since it is a known and effective zinc salt anticalculus agent as taught by Porter. It would have also been obvious to one of ordinary skill in the art to have incorporated zinc oxide into the composition of Georgiades since it occludes dentin tubules as well as taught by Porter.
Georgiades discloses wherein the composition may comprise abrasives. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated precipitated silica into the composition of Georgiades since it is a known and effective abrasive as taught by Porter.
Georgiades discloses wherein the composition may comprise additional ingredients. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated methionine into the composition of Georgiades since it is a known and effective additional ingredient that would provide a user with a nutrient as taught by Porter.
3. Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Georgiades (US 2003/0211052, Nov. 13, 2003) in view of Strand (US 2011/0020246, Jan. 27, 2011).
The teachings of Georgiades are discussed above. Georgiades does not teach wherein the composition comprises a monodentate ligand and a polydentate ligand.
However, Strand discloses an oral care composition comprising a stannous salt and a chelant (abstract). Suitable stannous sources include stannous fluoride (¶ [0019]). Suitable chelants include C2-C6 dicarboxylic and tricarboxylic acids, such as succinic acid (i.e., polydentate ligand), amino acids such as glycine (i.e., monodentate ligand), and mixtures thereof (¶ [0022]). The chelant stabilizes the stannous ions (¶ [0026]). For chelants with a molecular weight of less than 1000, the molar ratio of the chelant(s) used to the stannous ion delivered from the stannous salt is preferably at least 0.70:1 (¶ [0027]).
The composition of Georgiades may comprise stannous fluoride. Accordingly, it would have been prima facie obvious to one of ordinary to have incorporated succinic acid (i.e., polydentate ligand) and glycine (i.e., monodentate ligand) into the composition of Georgiades motivated by the desire to stabilize the stannous ions as taught by Strand.
In regards to instant claim 11 reciting wherein tin to monodentate ligand to polydentate ligand molar ratio of from about 1:0.5:0.5 to about 1:5:5, Strand discloses wherein the molar ratio of the chelant(s) used to the stannous ion delivered from the stannous salt is preferably at least 0.70:1. The claimed molar ratio would have been obvious from the molar ratio disclosed by Strand. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 9, 10, 12-22, and 25-36 of copending Application No. 17/308,078, and claims 1 and 7-28 of copending Application No. 17/580,685 in view of Georgiades (US 2003/0211052, Nov. 13, 2003). The pending claims differ from the copending claims insofar as disclosing an about 1% to about 5% dicarboxylic acid. However, Georgiades discloses wherein dicarboxylic acid may be incorporated into oral care compositions in an amount of less than about 5% (claim 6). As such, it would have been obvious to one of ordinary skill in the art to have incorporated less than about 5% dicarboxylic acid into the pending claims since this is a known and effective amount of dicarboxylic acid for oral care compositions as taught by Georgiades. In regards to the pending claims reciting a calcium loss in dentin and/or enamel of less than 50 ppm, the copending claimed composition comprises substantially the same components as the claimed composition; therefore, one of ordinary skill in the art would reasonably expect the composition of the copending claims have less than 50 ppm calcium loss in dentin and/or enamel like the claimed invention.
This is a provisional nonstatutory double patenting rejection.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 8-15, 18 and 20 of copending Application No. 18/911,823 (reference application), claims 1, 4, 6, 10 and 11 of copending Application No. 18/911,374 (reference application), and claims 1, 3, 5-7, 9, 12, 14 and 16-18 of copending Application No. 18/911,383 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite additional ingredients) and thus read on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-20 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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