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 .
Priority
This application claims priority to US provisional 63/589,396 filed on 10/11/2023.
Information Disclosure Statement
The information disclosure statements filed on 4/30/2025, 10/9/2025 and 6/22/2026 have been considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6, 8, and 10-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product or combination of natural products without significantly more. The claim(s) recite(s) a dentifrice composition with chemical whitening agent comprising malonic acid or a salt thereof (malonic acid found in plant products). The claims recite they are free or substantially free of certain items such as polyphosphates. Claims also recite the natural products of malonic acid, natural organic acids (e.g. oxalic acid, adipic acid, etc., see claim 5), zinc oxide, zinc phosphate, polysaccharide, silica, polymers that can include natural polymers, natural calcium compounds like calcium phosphate, etc, natural amino acids, glycerol and other natural polyols and water. Claim 6 is to pH, which is a property that occurs naturally based on acids and/or bases present. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims use natural products for the properties or characteristics they carry individually. Additionally, dentifrice composition is noted as being tooth or subgingival paste, gel or liquid (page 4 of specification) where liquid can just be compounds with water or other natural liquid. The whitening effect appears to occur due to the malonic acid, and thus, is a characteristic of the natural compound. Thus, the claims do not provide markedly different characteristics from the natural products as they exist nor do the combinations provide significantly more that what would be expected naturally from each of the individual compounds/agents.
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.
Claim 20 is 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 20 is indefinite with the use of “preferably” in the claim whether the limitation after preferably is considered part of the claim or is simply an exemplary preference of how removing could be performed. Applicant may amend the claim by removing the preferably limitation.
Claim Rejections - 35 USC § 102
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.
Claims 1-7 and 9-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baig et al. (US 20210346252).
Note that the only component claim 1 requires is malonic acid or a salt thereof for a whitening agent. Thus, a teaching of a composition/embodiment option with malonic acid or salt thereof anticipates the claim.
“Consisting essentially of” will be read as “comprising” until it is shown how other components of the prior art affect the novel and basic characteristics of the formulation (see MPEP 2111.03).
If the prior art is silent to mentioning a component or allows for a component to be “optional” (an alternative to others), then it allows for being free of such a component.
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 (Claim 27 of Baig and paragraph 52). 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. Baig teaches precipitated silica as silica abrasive (paragraph 89). 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 and claims 5 and 6 of Baig). 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 and table 1). Zinc salts are optional here. Humectants are taught in paragraph 98. 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. Baig notes the preventing of Sn stain without the addition of polyphosphates (paragraph 10). Peroxides (paragraph 97) are noted as optional. There are no bicarbonates or chlorohexidine provided in Baig. Baig teaches fluorides as optional (can comprise) (paragraphs 69-70) and teaches free of fluoride source (paragraph 73). Although some options of compounds with potassium are present in teachings of Baig, they are optional to other alternatives. Examples of Baig in table 1 have glycerin, sorbitol, water at 8.186%, stannous fluoride, stannous chloride, silica Z109 or silica Z119, Carrageenan, and xanthan gum (table 1). Note that buffering agents have alternatives to citric acid or sodium citrate (paragraph 80) and the zinc source can be zinc oxide instead of zinc citrate (paragraph 77). Baig also notes whitening agents including dicarboxylic acids (paragraph 97). Note that Baig provides malonic acid as option of dicarboxylic acid. Baig provides for about 0.0025% to about 5% of tin or 0.01 to 10% (paragraph 36).
In regard to the method claim, the composition may be used to whiten the teeth by application to the oral cavity via brushing or rinsing (paragraphs 0034, 0088, 0097 and 113-114). Baig teaches being instructed to expectorate the oral care composition after the brushing (paragraph 114).
In order to arrive at the composition of the instant claims, one would only need to use malonic acid, which is one of a limited group of options for listed dicarboxylic acids (see claim 27 of Baig).
Claims 1-10, 12-15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Georgiades US 20030211052A1.
Georgiades teaches “A tooth-whitening composition includes at least one dicarboxylic acid, such as oxalic acid malonic acid, tartaric acid, and/or a salt thereof as a whitening agent” (abstract). Georgiades teaches “The composition is effective for whitening teeth by removing extrinsic stains from external surfaces of the teeth. The composition also helps to maintain the teeth white by hindering the deposition of extrinsic stains on the external surfaces of teeth.” (abstract). Georgiades teaches pH of from 3 to below 7 and pH of 4.2 (paragraphs 41-42, see paragraph 83). Georgiades teaches “Sodium monofluorophosphate, sodium fluoride, stannous fluoride and mixtures of these compositions are preferred” as fluoride releasing compounds (paragraph 60). Table 3 provides for a mouthwash plus 0.1% and other concentrations of malonic acid (also note paragraph 83 with the mouthwash being Coolmint Listerine). Table 2 provides for the mouthwash when combined with oxalic acid. The mouthwash contains sorbitol (table 2). There is no polyphosphate, peroxide, chlorohexidine and bicarbonate present in table 2. The mouthwash in these examples of tables 2 and 3 do not indicate a stannous/tin or fluoride compound. The mouthwash in these examples do not have a zinc or potassium compound. Pluronic in table 2 would be a polymer (poloxamer). Note that table 1 provides for a toothpaste composition which has amorphous silica, water, glycerin, xanthan gum, sodium carboxymethylcellulose, sodium monofluorophosphate, oxalic acid, and other ingredients. Table 3 provides for citric acid as well as claim 26 of Georgiades. However, this ingredient may be optional in Georgiades teachings as there are options provided by tables 1, 2 and 3 with no citric acid or salt thereof. Georgiades teaches insoluble tricalcium phosphate, calcium pyrophosphate, calcium carbonate, silica and other polishing materials (paragraph 39). Claim 13 of Georgiades provides water as an optional vehicle with other options (ethanol and 1-propanol), and thus, no water is envisioned in formulations (also paragraph 22). Additionally, the table 2 compositions have no water, but use alcohol and propanol. Georgiades teaches “The compositions can be applied to the teeth and gums by any conventional means, such as brushing, spraying, painting or rinsing of the oral cavity and the like. Compositions of the invention are effective for whitening teeth by removing extrinsic stains from external surfaces of the teeth.” (paragraph 71). Brushing and mouthwash rinsing involve application to the oral cavity/teeth and then removal via spitting and/or rinsing out. A mouthwash or oral rinse is a composition that is spit out (expectorated) in practice.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Baig et al. (US 20210346252).
Applicant’s specification notes and defines that “substantially free” is no more than 0.05% (page 5).
Baig teaches the claims as discussed above with teachings of composition components as noted that allow for the claimed invention. Baig teaches a range of tin compound down to 0.0025% as noted above.
One of ordinary skill in art before the time of filing would have worked within the ranges of the prior art to provide formulations that were considered “substantially free” of tin due to the overlapping range of Baig. Thus, there was a reasonable expectation of success in providing a composition considered substantially free of tin while still providing a suitable dentifrice composition from the teachings of Baig.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Georgiades US 20030211052A1 and Potanin US20180221259A1.
Georgiades teaches the claims as discussed above.
Georgiades did not teach a zinc compound of claim 11 or an amino acid for claim 16.
Potanin teaches an oral care composition with basic amino acid and combination of zinc ion sources (abstract). Potanin teaches zinc oxide and zinc citrate (paragraphs 7-11, also paragraph 199). Potanin teaches L-arginine, histidine and lysine and others (paragraphs 146-147) as basic amino acids. Potanin provides its formulations improve oral health (claim 37 of Potanin). Item 1.46 of Potanin provides for calcium carbonate. Potanin provides for humectants (paragraphs 172-173).
One of ordinary skill in the art before the time of filing would have included zinc compounds (zinc oxide, zinc citrate) and amino acids of Potanin into the oral care formulations of Georgiades as formulations of the ingredients of Potanin help to improve oral health. Therefore, there was a reasonable expectation of success in combining the amino acid and zinc components of Potanin into formulations of Georgiades to obtain improved oral care formulations.
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 1-9, 12-16, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 10-16, 19-20, 22-24, 27, 31, 32, and 35 of copending Application No. 17/308,083 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for the compositions with malonic acid (see claim 27 of ‘083 for option of malonic acid) and other ingredients of applicant’s claims with overlapping pH value.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7, 9-10, 12, 14-16, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-6, 9-16, 19-20, 22-24, 27, and 31 of copending Application No. 17/308,085 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for the compositions with malonic acid (see claim 27 of ‘085 for option of malonic acid) and other ingredients of applicant’s claims with overlapping pH value.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, 12-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 7-10, 12, 15-18, 21-22, 25-30, and 32-36 of copending Application No. 17/308,078 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for the compositions with malonic acid (see claim 4 of ‘078 for option of malonic acid) and other ingredients of applicant’s claims with overlapping pH value.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 8, 10, 13-15, and 17-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-8, 10, 14-15, and 19 of copending Application No. 18/911,411 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for the compositions with malonic acid and other ingredients of applicant’s claims with overlapping pH value.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7, 9, 12, and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6-9, 11-12, 14, 17-20, and 22-23 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 each claim set provides for the compositions with malonic acid and other ingredients of applicant’s claims with overlapping pH value.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7, 9, 12, and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-7, 10-11, 13-14, 18-19, 22-23, and 25 of copending Application No. 18/911,374 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for the compositions with malonic acid and other ingredients of applicant’s claims with overlapping pH value.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8-12, and 14-20 of copending Application No. 18/911,395 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for the compositions with malonic acid and other ingredients of applicant’s claims with overlapping pH value.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, 12, 14, 16, and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 8-10, 12-13, 18, 20 and 21 of copending Application No. 18/911,823 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for the compositions with malonic acid and other ingredients of applicant’s claims with overlapping pH value.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7-9, 11-15 of copending Application No. 18/484,713 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for the compositions with malonic acid and other ingredients of applicant’s claims with overlapping pH value.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, 12-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-9, 12-16 and 18-20 of copending Application No. 18/936,549 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for the compositions with malonic acid and other ingredients of applicant’s claims with overlapping pH value.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7, 9-12, 16 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 10, 13-16 of copending Application No. 19/319939 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for the compositions with malonic acid and other ingredients of applicant’s claims with overlapping pH value.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-13, 16-20 of copending Application No. 19/645613 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for the compositions with malonic acid and other ingredients of applicant’s claims with overlapping pH value.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7, 9, 11-12, 16, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 10, 13-16 of U.S. Patent No. 12427097. Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for the compositions with malonic acid and other ingredients of applicant’s claims with overlapping pH value.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
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