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 1-23.
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 1-4, 9, 10, 12 and 14-23 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 a least one dicarboxylic acid, such as oxalic acid, malonic acid, tartaric acid, and/or or a salt thereof as a whitening agent. The composition can be provided in a variety of forms, including a mouthwash and a toothpaste (abstract). The whitening agent is present at a tooth-whitening effective concentration. A tooth-whitening effective concentration is preferably less than 10% (or about 10%) (¶ [0031]). The composition may comprise fluoride-releasing compounds, such as sodium monofluorophosphate, sodium fluoride, stannous fluoride (i.e., tin ion source), and mixtures thereof (¶ [0060]). The fluoride-releasing compound will be present in an amount of up to about 1.2% (¶ [0061]). The pH of the composition may be about 4.2 (claim 11). The composition may comprise polishing materials, such as silica (¶ [0039]). The composition may include additional ingredients (¶ [0038]).
The prior art discloses a composition containing dicarboxylic acid (abstract), a fluoride-releasing compound (¶ [0060]), and silica (¶ 0039]). Together these would provide a composition as claimed instantly.
The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
In regards to instant claims 2, 14, 17, 19, and 22 reciting wherein after 12 months of aging at about 20°C, the composition has a soluble fluoride level that is more than 50% of a theoretical amount of fluoride, as noted in Table 8 of the instant specification, a composition comprising 1500 ppm (0.15%) MFP and malonate has 90% soluble fluoride after 12 months. Accordingly, since Georgiades teaches a composition comprising 0.15% sodium monofluorophosphate and malonate, the composition of Georgiades meets the claimed property.
In regards to instant claim 12 reciting wherein the composition is free of zinc, Georgiades does not teach wherein the composition requires zinc (see abstract and claim 1). Therefore, a composition free of zinc would have been obvious.
In regards to instant claim 16 reciting wherein the composition is essentially free of sodium fluoride, as discussed above, Georgiades discloses wherein the fluoride-releasing compound may be sodium monofluorophosphate instead of sodium fluoride. Therefore, a composition free of sodium fluoride would have been obvious.
In regards to instant claim 23 reciting wherein the composition is essentially free of or free of an oxalic acid or a salt thereof, as discussed above, Georgiades discloses wherein the dicarboxylic acid may be malonic acid instead of oxalic acid. Therefore, a composition free of oxalic acid or a salt thereof would have been obvious.
2. Claims 5, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Georgiades (US 2003/0211052, Nov. 13, 2003) in view of Sinclair (US 2014/0271900, Sep. 18, 2014).
The teachings of Georgiades are discussed above. Georgiades does not teach wherein the silica polishing material contains residual aluminum or calcium.
However, Sinclair discloses a dentifrice composition comprising a silica material having high cleaning and low abrasion properties (abstract). The silica composition can provide high cleaning properties while maintaining desirable abrasive properties (¶ [0059]). The silica material can comprise up to, for example, about 12% aluminum, calcium, or a combination thereof. In another aspect, the silica material does not comprise aluminum and/or calcium in quantities greater than trace or impurity levels (¶ [0035]).
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 comprises silica. Accordingly, it would have been obvious to one ordinary skill in the art to have incorporated the silica of Sinclair into the composition of Georgiades since it is a known and effective silica polishing material with desirable abrasive properties as taught by Sinclair.
3. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Georgiades (US 2003/0211052, Nov. 13, 2003) in view of Haught et al. (US 2011/0293541, Dec. 1, 2011) (hereinafter Haught).
The teachings of Georgiades are discussed above. Georgiades does not teach wherein the silica polishing material contains residual iron.
However, Haught discloses an oral care composition comprising silica from plant materials (¶ [0002]). The silica is used as an abrasive material (¶ [0040]). The plant material is burned to remove organic impurities from the plant material (¶ [0016]). For many plant materials, the burning step may not be sufficient to remove all impurities, specifically inorganic impurities. Consequently, the inorganic impurities may be removed from the burnt plant material by hydrolyzing with an aqueous acid solution. After hydrolysis, the hydrolyzed plant material may be dried or rinsed. Rinsing may be performed with as pure water as is practical, such as de-ionized or even distilled water, with very low iron or heavy metal content, to prevent the water itself from contributing undesirable impurities to the silica (¶ [0019]).
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 comprises silica. Accordingly, it would have been obvious to one ordinary skill in the art to have incorporated the silica of Haught into the composition of Georgiades since it is a known and effective silica polishing material as taught by Sinclair.
In regards to instant claim 6 reciting up to about 500 ppm iron, Haught discloses wherein the plant material from which silica is derived from may be rinsed with very low iron content and wherein the water affects the impurities of silica. Thus, it would have been obvious to one of ordinary skill in the art that the silica of Haught a very low iron content.
4. Claim 11 is 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 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.
5. Claim 13 is 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 composition comprises an amino acid.
However, Porter discloses an oral care composition comprising zinc oxide (abstract). The composition may optionally comprise a nutrient. Suitable nutrients include amino acids such as methionine (¶ [0081]).
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.
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 1-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application Nos. 18/484,713, 17/971,728, 18/936,549, and 19/327,214 (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 required 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.
Claims 1-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application Nos. 19/352,769, 18/911,395, 18/911,341, 17/580,685, and 17/308,078 in view of Georgiades (US 2003/0211052, Nov. 13, 2003). The pending claims differ from the copending claims insofar as reciting an amount of dicarboxylic acid. However, Georgiades discloses a tooth-whitening composition comprising a least one dicarboxylic acid, such as oxalic acid, malonic acid, tartaric acid, and/or or a salt thereof as a whitening agent (abstract). The whitening agent is present at a tooth-whitening effective concentration. A tooth-whitening effective concentration is preferably less than 10% (or about 10%) (¶ [0031]). Accordingly, the claimed amount of dicarboxylic acid would have been obvious since it is a known and effective amount for whitening teeth as taught by Georgiades.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-23 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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