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
Claim Rejections - 35 USC § 112 - Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 18-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation "the pH" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the oral care composition" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the oral care composition" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102 – Anticipation
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
1) Claims 1-6, 9, 14-15 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Groth et al. (US 20230133630).
Groth et al. disclose oral care compositions, such as whitening dentifrice compositions. The compositions comprise dicarboxylic acid, malonic acid, and have a pH of from about 4 to about 6 (Abstract). A metal source includes zinc and potassium salts. Zinc salts include zinc citrate (paragraph 0054). Potassium salts include potassium nitrate (paragraph 0056). The oral care composition can comprise one or more thickening agents. Thickening agents may be used in the oral care compositions to provide a gelatinous structure that stabilizes the toothpaste against phase separation. Suitable thickening agents include polysaccharides, polymers, and/or silica thickeners. Polysaccharides include xanthan gum and carrageenan and mixtures thereof (paragraph 0086). Amino acids may be added and include arginine, histidine, lysine, aspartic acid, glutamic acid, serine, threonine, asparagine, glutamine, cysteine, selenocysteine, glycine, proline, alanine, valine, isoleucine, leucine, methionine, phenylalanine, tyrosine, tryptophan and citrulline (paragraph 0096). Citric acid may be used in the composition as a polydentate ligand (paragraph 0081). Fluoride may be added and includes sodium fluoride and stannous fluoride (paragraph 0045). Abrasives include calcium abrasives and silica abrasive. Calcium abrasives include calcium carbonate and calcium pyrophosphate (paragraph 0091). A toothpaste comprises glycerin, water, xanthan gum, carrageenan, Silica Z165, Silica Z109, Silica Z119, flavor and sodium acid pyrophosphate (TABLE 1C, composition 1). Malonic acid is added to the toothpaste (TABLE 1A), Ex. 1). The composition does not comprises a zinc salt or carboxymethyl cellulose.
In regards to the properties of the instant claims, the composition of Baig et al. comprises a combination of xanthan gum and carrageenan with an amorphous silica and malonic acid (thickening agent). Therefore, the composition of reference would have substantially the same properties; a PCR value of at least 115, and a pH after brushing for about 30 seconds of about 5.3 or less; of the instant claims.
Goth et al. anticipate the instant claims.
2) Claims 1-6, 9-12, 15 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baig et al. (US 20210346252).
Baig et al. disclose oral care compositions. The compositions comprise tin, monodentate ligand, polydentate ligand with low RDA values. Dentifrice compositions with a unique ratio of monodentate ligand to polydentate ligand to stabilize tin (Abstract). The polydentate ligand can comprise oxalic acid, malonic acid, succinic acid, glutaric acid, adipic acid, pimelic acid, suberic acid, azerlaic acid, sebacic acid, undecanedioic acid, dodecanedioic acid, brassylic acid, thapsic acid, japanic acid, phellogenic acid, equisetolic acid, malic acid, tartaric acid, citric acid; salts thereof, and/or combinations thereof. The polydentate ligand comprises 0.01% to about 10% by weight of the composition. The oral care composition can comprise one or more thickening agents. Thickening agents can be useful in the oral care compositions to provide a gelatinous structure that stabilizes the toothpaste against phase separation. Suitable thickening agents include polysaccharides, polymers, and/or silica thickeners. Some non-limiting examples of polysaccharides include xanthan gum, and carrageenan; and mixtures thereof. The oral care composition can comprise from 0.01% to about 15%, from 0.1% to about 10%, from about 0.2% to about 5%, or from about 0.5% to about 2% of one or more thickening agents (paragraph 0082 to 0086). Abrasives include calcium abrasives and silica abrasives. Calcium abrasives include calcium carbonate and calcium pyrophosphate (paragraphs 0087 to 0089). Amino acids may be added and include arginine, histidine, lysine, aspartic acid, glutamic acid, serine, threonine, asparagine, glutamine, cysteine, selenocysteine, glycine, proline, alanine, valine, isoleucine, leucine, methionine, phenylalanine, tyrosine, tryptophan and citrulline. Zinc salts may be added and include zinc citrate (paragraph 0077). The pH of the composition may range from 4.5 to 5.5 (paragraph 0079). An oral care composition comprises glycerin, sorbitol, stannous fluoride, Silica Z109 (precipitated silica), Silica 119 (a thickening silica), sodium citrate, xanthan gum, carrageenan, and water. The example does not comprises carboxymethyl cellulose.
In regards to the method claim, the composition may be used to whiten the teeth (paragraphs 0034 and 0097).
In order to arrive at the composition of the instant claims, one would only need to replace citrate with malonic acid.
In regards to the properties of the instant claims, the composition of Baig et al. comprises a combination of xanthan gum and carrageenan with an amorphous silica and malonic acid (thickening agent). Therefore, the composition of reference would have substantially the same properties; a PCR value of at least 115, and a pH after brushing for about 30 seconds of about 5.3 or less; of the instant claims.
Baig et al. anticipate the instant claims.
Claim Rejections - 35 USC § 103 - Obviousness
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.
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.
1) Claims 1-12 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Baig et al. (US 20210346252).
Baig et al. disclose oral care compositions. The compositions comprise tin, monodentate ligand, polydentate ligand with low RDA values. Dentifrice compositions with a unique ratio of monodentate ligand to polydentate ligand to stabilize tin (Abstract). The polydentate ligand can comprise oxalic acid, malonic acid, succinic acid, glutaric acid, adipic acid, pimelic acid, suberic acid, azerlaic acid, sebacic acid, undecanedioic acid, dodecanedioic acid, brassylic acid, thapsic acid, japanic acid, phellogenic acid, equisetolic acid, malic acid, tartaric acid, citric acid; salts thereof, and/or combinations thereof. The polydentate ligand comprises 0.01% to about 10% by weight of the composition. The oral care composition can comprise one or more thickening agents. Thickening agents can be useful in the oral care compositions to provide a gelatinous structure that stabilizes the toothpaste against phase separation. Suitable thickening agents include polysaccharides, polymers, and/or silica thickeners. Some non-limiting examples of polysaccharides include xanthan gum, and carrageenan; and mixtures thereof. The oral care composition can comprise from 0.01% to about 15%, from 0.1% to about 10%, from about 0.2% to about 5%, or from about 0.5% to about 2% of one or more thickening agents (paragraph 0082 to 0086). Abrasives include calcium abrasives and silica abrasives. Calcium abrasives include calcium carbonate and calcium pyrophosphate (paragraphs 0087 to 0089). Amino acids may be added and include arginine, histidine, lysine, aspartic acid, glutamic acid, serine, threonine, asparagine, glutamine, cysteine, selenocysteine, glycine, proline, alanine, valine, isoleucine, leucine, methionine, phenylalanine, tyrosine, tryptophan and citrulline. Zinc salts may be added and include zinc citrate (paragraph 0077). The pH of the composition may range from 4.5 to 5.5 (paragraph 0079). An oral care composition comprises glycerin, sorbitol, stannous fluoride, Silica Z109 (precipitated silica), Silica 119 (a thickening silica), sodium citrate, xanthan gum, carrageenan, and water. The example does not comprises carboxymethyl cellulose.
In regards to the method claim, the composition may be used to whiten the teeth (paragraphs 0034 and 0097).
Baig et al. differ from the instant claims insofar as it does not exemplify a composition comprising malonic acid, citric acid, an additional acid, a tin ion source, a fluoride ion source, potassium nitrate, and amino acid, and/or a calcium abrasive.
However, 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. It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added malonic acid, citric acid, an additional acid, a tin ion source, a fluoride ion source, potassium nitrate, and amino acid, and/or a calcium abrasive to the exemplified composition of Goth et al. because of their suitability and to obtain their known therapeutic functions as a pH adjusting agent, an anticaries agent, a desensitizing agent and a polishing agent.
In regards to the properties of the instant claims, the composition of Baig et al. comprises a combination of xanthan gum and carrageenan with an amorphous silica and malonic acid (thickening agent). Therefore, the composition of reference would have substantially the same properties; a PCR value of at least 115, and a pH after brushing for about 30 seconds of about 5.3 or less; of the instant claims.
2) Claims 1, 7-13 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Groth et al. (US 20230133630) as applied above.
Groth et al. disclose oral care compositions, such as whitening dentifrice compositions. The compositions comprise dicarboxylic acid, malonic acid, and have a pH of from about 4 to about 6 (Abstract). A metal source includes zinc and potassium salts. Zinc salts include zinc citrate (paragraph 0054). Potassium salts include potassium nitrate (paragraph 0056). The oral care composition can comprise one or more thickening agents. Thickening agents may be used in the oral care compositions to provide a gelatinous structure that stabilizes the toothpaste against phase separation. Suitable thickening agents include polysaccharides, polymers, and/or silica thickeners. Polysaccharides include xanthan gum and carrageenan and mixtures thereof (paragraph 0086). Amino acids may be added and include arginine, histidine, lysine, aspartic acid, glutamic acid, serine, threonine, asparagine, glutamine, cysteine, selenocysteine, glycine, proline, alanine, valine, isoleucine, leucine, methionine, phenylalanine, tyrosine, tryptophan and citrulline (paragraph 0096). Citric acid may be used in the composition as a polydentate ligand (paragraph 0081). Fluoride may be added and includes sodium fluoride and stannous fluoride (paragraph 0045). Abrasives include calcium abrasives and silica abrasive. Calcium abrasives include calcium carbonate and calcium pyrophosphate (paragraph 0091). A toothpaste comprises glycerin, water, xanthan gum, carrageenan, 2% Silica Z165 (thickening silica), Silica Z109, 7% Silica Z119 (thickening silica), flavor and sodium acid pyrophosphate (TABLE 1C, composition 1). Malonic acid is added to the toothpaste (TABLE 1A), Ex. 1).
Groth et al. differ from the instant claims insofar as it does not exemplify a composition comprising citric acid, an additional acid, a tin ion source, a fluoride ion source, potassium nitrate, and amino acid, and/or a calcium abrasive.
However, 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. It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added citric acid, an additional acid, a tin ion source, a fluoride ion source, potassium nitrate, and amino acid, and/or a calcium abrasive to the exemplified composition of Groth et al. to obtain their known therapeutic functions as pH adjusting agent, anticaries agent, desensitizing agent and polishing agent.
In regards to the properties of the instant claims, the composition of Groth et al. comprises a combination of xanthan gum and carrageenan with an amorphous silica and malonic acid (thickening agent). Therefore, one of ordinary skill in the art would reasonably conclude that the composition of Groth et al. would have substantially the same properties; a PCR value of at least 115, and a pH after brushing for about 30 seconds of about 5.3 or less; of the instant claims.
Claims 1-20 are rejected.
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612
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