CTNF 18/835,957 CTNF 87614 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. Claim Status Claims 1-20 are pending and are examined on the merits in this prosecution. CLAIM REJECTIONS Obviousness Rejection 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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) Claim 1-11, 13, 16-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jha (WO 2019/045781 A1, cited on IDS dated 8/5/2024), in view of Mourao (US 2017/0189300 A1). Jha teaches an oral care compositions which contain antibacterial amounts of zinc, a calcium carbonate base; a gum system; and a natural ingredient component (Abstract). Specifically, Jha teaches the composition comprises zinc oxide, zinc citrate, calcium carbonate, an herbal extract, an essential oil (pg 1, (0004]), and an oleoresin (pg 4, [0017]). For claim 2, Jha teaches the ratio of the amount of zinc oxide (e.g., wt.%) to zinc citrate (e.g., wt%) is from 1.5:1 to 4.5:1, the claimed ratio. For claims 3 and 18, Jha teaches zinc citrate and zinc oxide, wherein the zinc citrate is in an amount of from 0.25 to 1 wt% and zinc oxide may be present in an amount of from 0.75 to 1.25 wt%) based on the weight of the oral care composition (pg 2, section 1.2). For claims 4 and 5, regarding the one or more herbal extracts and the one or more essential oils, Jha teaches the herbal extract is selected from amla extract, honey extract, almond extract aloe vera extract, maricha extract, ginger extract, fenugreek, and combinations of two or more thereof (pg 22, claim 8), and the essential oil is selected from neem seed oil, sesame oil, cinnamon leaf oil, clove oil, thyme oil, eucalyptus oil, eugenol, menthol, babool, camphor, and combinations of two or more thereof (pg 22, claim 9). For claim 6, Jha teaches the total amount of herbal extract or essential oil is from about 0.1 to about 5% Pg 4, [0017]), overlapping the claimed range. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists. For claim 13, Jha teaches high cleaning silica can be added to the composition (pg 5, [0020]). For claim 16, Jha teaches the composition may comprise a combination of refined natural calcium carbonate and precipitated calcium carbonate in a combined amount of from about 5% to about 70% (pg 9, [0036]); in Example 1, the amount of precipitated calcium carbonate is 9% (pg 10), within the claimed range. For claim 17, Jha teaches the composition may comprise a combination of refined natural calcium carbonate and precipitated calcium carbonate in a combined amount of from about 5% to about 70% (pg 9, [0036]); in Example 1, the amount of natural calcium carbonate is 35% (pg 10), within the claimed range. Jha does not teach an oral care compositions which contains a gum system comprising xanthan gum and carboxymethyl cellulose. Mourao teaches the missing element of Jha. Mourao teaches a dentifrice compositions comprising at least one zinc ion source, and a thickening system comprising xanthan gum present in the composition in an amount ranging from about 0.3% to about 1% by weight and carboxymethyl cellulose present in the composition in an amount ranging from about 1% to about 2% by weight (Abstract). Mourao also teaches the dentifrice may comprise herbal extracts or essential oil (pg 4, [0034] and pg 5, [0042]) and calcium carbonate (pg 4, [0033]). Mourao suggests or teaches that the adjuvants disclosed in the composition such as zinc salts, fluoride sources, herbal extracts, and essential oils, added in amounts up to 5%, do not adversely affect the stability, viscosity, and cleansing properties of the disclosed dentifrice composition (pg 6, [0046]). For claims 7-8 the ratio of xanthan gum to carboxymethyl cellulose overlap the claimed range. For claim 9, the amount of carboxymethyl cellulose taught by Mourao overlaps the claimed range. For claim 10, the amount of xanthan gum taught by Mourao overlaps the claimed range. For claim 11, the amount of carboxymethyl cellulose taught by Mourao and the amount of xanthan gum taught by Mourao each overlaps the claimed range. For claims 19 and 20, Jha teaches the method of “method of treating or preventing a disease or condition of the oral cavity comprising contacting an oral cavity surface of a patient in need thereof with the oral care composition” (pg 22, claim 15) and a “method according to claim 15, wherein the disease or condition of the oral cavity is a disease or condition caused by oral bacteria” (pg 23, claim 16). The skilled artisan would have expected success in substituting Mourao's gum system comprising xanthan and carboxymethyl cellulose in the claimed amounts for the carrageenan gum system of Jha (pg 1, [0004]) because Mourao suggests or teaches that the adjuvants disclosed in the composition such as zinc salts, fluoride sources, herbal extracts, and essential oils, added in amounts up to 5%, do not adversely affect the stability, viscosity, and cleansing properties of the disclosed dentifrice composition, and Jha teaches that carboxymethyl cellulose, alone or combined with PEG 600, provides a toothpaste composition that, when aged, is difficult to squeeze, separates, and may discolor (see Comparative Examples A and B, pgs 9-13). 2) Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Jha (cited above), in view of Mourao (cited above) and Thomson (US 2017/0367948 A1). The teachings of Jha and Mourao are discussed above. The combination of Jha and Mourao does not teach the addition of gum arabic to the gum system. Thomson teaches the missing element of the combination of Jha and Mourao. Thomson teaches oral care compositions comprising zinc citrate and zinc oxide (Abstract). Thomson teaches that the oral care composition can comprise a combination of sodium carboxymethyl cellulose and xanthan as thickening agents (pg 3, [0057]-[0058] and pg 6, [0123]). Thomson further teaches that it is sometimes necessary to add an additional thickening material such as gum arabic to provide a desirable consistency or to further stabilize the composition (pg 6, [0128]). The skilled artisan would have expected success in adding Thomson's gum arabic to the composition of the combination of Jha and Mourao since Thomson teaches that it may be necessary to add an additional thickening material such as gum arabic to provide a desirable consistency or to further stabilize the composition. 3) Claims 14-15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Jha (cited above), in view of Mourao (cited above), Bazemore (US 2009/0317461 A1), and Bernstein (US 2004/0146464 A1). The teachings of Jha and Mourao are discussed above. The combination of Jha and Mourao does not teach the addition of the oleoresins recited in claims 14, 15, and 18 to the oral care composition. Bazemore teaches the missing element of the combination of Jha and Mourao. Bazemore teaches oral care compositions, including toothpaste, effective for the treatment of oral cavity malodor caused by odor-causing compounds (Abstract; pg 16, claim 16). Bazemore teaches the composition may include warming flavoring compounds for trigeminal stimulation such as capsicum (chili pepper) oleoresin, red pepper oleoresin, black pepper oleoresin, and ginger oleoresin (pg 4, 0039]). Bernstein teaches a toothpaste composition for providing the benefits of reducing inflammation of the gums, as well as sensitivity of the teeth to extremes of temperature, comprising about 0.001% to 0.1% by weight of capsaicin in a toothpaste vehicle (Abstract). For claim 18, the amounts of each of zinc oxide and zinc citrate taught by Jha overlap the respective claimed ranges. Jha teaches an amount of sodium monofluorophosphate of 0.76% (pg 10, Table 1; pg 17, Table 9) that overlaps the claimed range, as well as the claimed herbal extracts and essential oils; Mourao teaches the claimed amounts of xanthan gum and carboxymethyl cellulose; and Bazemore and Bernstein teach the addition of ginger oleoresin and pepper oleoresin to toothpaste compositions. The person of ordinary skill would have had a reasonable expectation of success in adding pepper oleoresin and ginger oleoresin to the toothpaste composition of Jha and Mourao, as taught by Bazemore and Bernstein, since Bazemore teaches pepper oleoresin and ginger oleoresin complement the flavoring profile of toothpaste by adding a warming component and Bernstein teaches the capsaicin oleoresin taught by Bazemore also reduces gum inflammation and tooth sensitivity. CONCLUSION Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (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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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MICHAEL P COHEN/Primary Examiner, Art Unit 1612 Application/Control Number: 18/835,957 Page 2 Art Unit: 1612 Application/Control Number: 18/835,957 Page 3 Art Unit: 1612 Application/Control Number: 18/835,957 Page 4 Art Unit: 1612 Application/Control Number: 18/835,957 Page 5 Art Unit: 1612 Application/Control Number: 18/835,957 Page 6 Art Unit: 1612 Application/Control Number: 18/835,957 Page 7 Art Unit: 1612 Application/Control Number: 18/835,957 Page 8 Art Unit: 1612 Application/Control Number: 18/835,957 Page 9 Art Unit: 1612 Application/Control Number: 18/835,957 Page 10 Art Unit: 1612
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