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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Database GNPD Mintel (Toothpaste Repackaging, May 14, 2007) (IDS reference) in view of Deng et al. (WO 2013/034421 A2, Mar. 14, 2013) (IDS reference) and Winston et al. (US 5,385,727, Jan. 31, 1995) (IDS reference).
Database GNPD Mintel discloses a toothpaste (i.e., dentifrice) comprising aqua (i.e., water), sodium bicarbonate, glycine, sodium fluoride, sorbitol (i.e., humectant), hydrated silica, and acacia senegal gum (i.e., claimed natural gum).
Database GNPD Mintel differs from the instant claims insofar as not disclosing wherein the toothpaste comprises about 15% to about 55% or about 25% to about 45% water, about 0.05% to about 5% glycine, about 0.0025% to about 2% or about 0.5 to about 1.5% sodium fluoride, and asparagine; and wherein the composition has a pH greater than about 7.3 and is a single-phase toothpaste.
However, Deng et al. disclose a dentifrice composition comprising at least 0.1% by weight of organic acid having 1 to 3 carboxylic acid groups; wherein the dentifrice composition has a pH of greater than 6.0 (claim 1). Certain organic acids and their salts, namely organic acid having 1 to 3 carboxylic acid groups, enhance the generation of enamel-like HAP crystals on tooth surfaces (page 10, lines 23-25). Preferably the composition comprises the organic acid in an amount in the range of 0.2 to 20% by weight (page 11, lines 6-7). The organic acid may be an acidic amino acid, neutral amino acid or a mixture thereof. Suitable amino acids include glycine and asparagine and mixtures thereof (page 11, lines 10-12). It is preferred that the pH of the composition is in the range 7.0 to 11.0 (page 13, lines 16-17). In one embodiment the composition may be substantially free of phosphate source. This is especially preferred when the composition is a monophase hydrous composition comprising from 20 to 90% water. Presence of both calcium and phosphate sources in a monophase hydrous formulation can lead to premature reaction of the calcium and phosphate and instability of the product (page 12, lines 15-21). The dentifrice may be a toothpaste (page 9, line 28). In a preferred embodiment the dentifrice comprises a fluoride source. Suitable fluoride sources include sodium fluoride. The composition comprises the fluoride source in an amount from 0.01 to 12% (page 13, lines 21-26).
It would have been prima facie obvious to one of ordinary skill in the art to have formulated the toothpaste of Database GNPD Mintel to comprise 20 to 90% water, 0.2 to 20% glycine and 0.01 to 12% sodium fluoride since Database GNPD Mintel does not disclose the amount of water, glycine, and sodium fluoride and 20 to 90% water, 0.2 to 20% glycine and 0.01 to 12% sodium fluoride are known and effective amounts for these components in toothpaste compositions as taught by Deng et al.
It would have been prima facie obvious to one of ordinary skill in the art to incorporated asparagine into the toothpaste of Database GNPD Mintel motivated by the desire to enhance the generation of enamel-like HAP crystals on tooth surfaces since asparagine has such function as taught by Deng. In regards to the composition comprising both glycine and asparagine, Deng et al. disclose wherein mixtures of glycine and asparagine may be used to enhance the generation of enamel-like HAP crystals on tooth surfaces. Also, generally, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for same purpose, in order to form a third composition to be used for the very same purpose. The idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06. Thus, since both glycine and asparagine enhance the generation of enamel-like HAP crystals on tooth surfaces, it would have been obvious to have used them both for the same purpose.
It would have been prima facie obvious to one of ordinary skill in the art to have formulated the toothpaste of Database GNPD Mintel to have a pH of greater than 6.0 since Database GNPD Mintel does not disclose a pH for the toothpaste and a pH of greater than 6.0 is a known and effective pH for toothpaste compositions as taught by Deng et al.
It would have been prima facie obvious to one of ordinary skill in the art to have formulated the toothpaste of Database GNPD Mintel to be a monophase composition since the toothpaste does not comprise calcium and phosphate and thus does not need to be a dual phase composition as taught by Deng et al.
The combined teachings of Database GNPD Mintel and Deng et al. do not disclose wherein the toothpaste comprises about 20% to about 40% or about 40% sodium bicarbonate, 0% to about 5% sorbitol, 0.01% to about 10% hydrated silica, and about 5% to about 50% calcium carbonate.
However, Winston et al. disclose a dentifrice comprising sodium bicarbonate and other conventional ingredients such as secondary abrasives (abstract). The dentifrice may be in the form of a toothpaste comprising 3-70% sodium bicarbonate (col. 2, lines 49-52). A humectant is also a desirable component in a toothpaste. Preferably, the humectant comprises about 5-50% of the formulation (col. 3, lines 3-5). Suitable humectants include sorbitol (col. 4, lines 29-30). Suitable secondary abrasives include water-insoluble abrasives such as calcium carbonate and hydrated silica (col. 4, lines 50-57). The water-insoluble abrasive may be present in amounts of up to about 50% (col. 5, lines 1-2). The composition may comprise inorganic thickeners such as hydrated silica (col. 4, line 47).
It would have been prima facie obvious to one of ordinary skill in the art to formulated the toothpaste of Database GNPD Mintel to comprise 3-70% sodium bicarbonate, about 5-50% sorbitol, up to about 50% hydrated silica (i.e. claimed silica abrasive) since Database GNPD Mintel does not disclose the amount of sodium bicarbonate, sorbitol, and hydrated silica and 3-70% sodium bicarbonate, about 5-50% sorbitol, and up to about 50% hydrated silica are known and effective amounts for these components in toothpaste compositions as taught by Winston et al.
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated up to about 50% calcium carbonate into the toothpaste of Database GNPD Mintel since it is desirable to incorporate secondary abrasives with sodium bicarbonate and up to about 50% calcium carbonate is a known and effective secondary abrasive and amount thereof for toothpaste compositions as taught by Winston et al.
In regards to instant claim 14 reciting wherein the dentifrice composition comprises calcium-containing abrasive and silica abrasive, generally, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for same purpose, in order to form a third composition to be used for the very same purpose. The idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06. Thus, since calcium carbonate and hydrated silica are both known secondary abrasives, it would have been obvious to have incorporated them both as secondary abrasives.
In regards to instant claim 15 reciting wherein the dentifrice composition comprises a thickening silica, the toothpaste of Database GNPD Mintel comprises hydrated silica. Winston et al. disclose wherein hydrated silica is an inorganic thickener. Thus, hydrated silica is a thickening silica.
In regards to instant claims 1 and 19, Database GNPD Mintel does not disclose wherein the glycine is complexed or complexed with zinc. Therefore, a neutral amino acid that is uncomplexed and is not complexed with zinc would have been obvious.
Conclusion
Claims 1-20 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1612