DETAILED ACTION
Background
The amendment dated April 28, 2026 (amendment) amending claims 12, 18-19 and 22 and canceling claims 21 and 23-24 has been entered. Claims 12-13, 18-20, 22 and 25-28 as filed with the amendment have been examined. Claims 1-11, 14-17, 21 and 23-24 have been canceled. The All outstanding objections to the instant claims have been withdrawn. In view of the cancelation of claims 21 and 23-24, all outstanding rejections of those claims have been canceled.
The amendment to the instant specification dated April 28, 2026 has been entered. The outstanding objections to the specification have been withdrawn.
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 .
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 12-13, 18-19, 22 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over US2012/0082630 A1 to Haught et al. (Haught) in view of US2020/0138071 A1 to Shi et al. (Shi), both of record, and US20160000679 A1 to Yamasaki et al. (Yamasaki).
Regarding instant claims 12-13, 21-22 and 25-27, Haught discloses at Abstract oral care compositions (“flavored product” as an oral care product of claim 13) comprising saccharin (“high-intensity sweetener”), sucralose (claim 22 as a high-intensity sweetener in claim 21) and a rebaudioside (“natural steviol glycoside”) having an improved taste profile (a “taste-modifying composition”). In Example IV at [0070] and the accompanying Table on page 12, Haught discloses a mouth rinse composition comprising hydrogen peroxide, a total amount of sweetener of from 0.06 to 0.08 wt% (600 to 800 ppm), flavoring (claim 25) which has a minty taste (claim 26, see also Haught at [0039]), a coolant (“cooling enhancing compound”- claim 27, see also [0041]) and water. Further, Haught at [0039] discloses as another component a flavor including undecalactone gamma and combinations with other lactones or flavors. In addition, Haught at [0029] discloses a total sweetener content of 0.001 wt% to 4 wt% (10 ppm to 40,000 ppm), which the claimed 1 to 1000 ppm of a concentration of compounds of groups (a) and (b) in the flavored product flavored product of claim 12 overlaps. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", the Office considers that a prima facie case of obviousness exists. See MPEP 2144.05.I. The ordinary skilled artisan would have found it obvious in view of Haught to include its taste-modifying composition in its flavored product in the amount of 1 to 1000 ppm of the flavored product because Haught discloses that desirable flavored products comprise the claimed amount of a taste-modifying composition.
Haught does not disclose glucosylated natural steviol glycosides or GSGs in its taste-modifying composition; further, Haught does not disclose a flavored product comprising a taste-modifying composition of (a) the GSGs and (b) additional components of (ii) a combination of lactones comprising dihydromintlactone, a 5-membered lactone without any unsaturated bonds selected from the group consisting of butyrolactone gamma, valerolactone gamma, hexalactone gamma, heptalactone gamma, octalactone gamma, undecalactone gamma, decalactone gamma, dihydrojasmone lactone, and gamma nonalactone; and a 6-membered lactone without any unsaturated bonds selected from the group consisting of undecalactone delta, decalactone delta, dodecalactone delta, and cyclohexyl lactone as in claim 12. In addition, Haught does not disclose an amount of from 1 to 1000 ppm, based on the total weight of its flavored product, of total glucosylated natural steviol glycosides and the additional components as in claim 12. However, Haught at [0039] discloses γ-decalactone, γ-nonalactone, γ-undecalactone as flavors, each of which are lactones comprising a 5-membered cyclic lactone ring and not having unsaturation.
The Office considers the claimed combination of lactones as including any combination of three lactones one from each of the three recited groups of (i) a dihydromintlactone; (ii) a lactone selected from the group consisting of butyrolactone gamma, valerolactone gamma, hexalactone gamma, heptalactone gamma, octalactone gamma, undecalactone gamma, decalactone gamma, dihydrojasmone lactone, and gamma nonalactone; and, (iii) a group of a 6-membered lactone without any unsaturated bonds selected from the group consisting of undecalactone delta, decalactone delta, dodecalactone delta, and cyclohexyl lactone.
Shi at Abstract discloses Stevia extract containing sweeteners or flavorants for orally consumable products (“flavored products”) including (at [0892]) oral hygiene and dental compositions. At pages 108-110 of Shi in Example 12 at [1300] and [1304] and accompanying Tables 12-1 and 12-2, and at Example 13 at [1305] and [1308] and accompanying Tables 13-1 and 13-2, Shi discloses compositions having improved flavor and mouthfeel comprising, respectively, in Examples 12-02 to 12-07 discloses a composition of 100 ml water and 15 mg sucralose (150 ppm) with from 1.5 to 15 mg (15 to 150 ppm) of GSGs and, in Examples 13-02 to 13-08 discloses a composition of 100 ml water and 20 mg acesulfame-K (200 ppm) with from 2 to 80 mg (20 to 800 ppm) of GSGs. Thus, Shi at Examples 12 and 13 discloses amount of GSGs of from about 15 to about 800 ppm, based on the total weight of its flavored product.
Yamasaki at Abstract discloses lactone-containing malodor eliminating compositions added to a variety of products, including, but not limited to, foods, beverages, toothpastes, mouthwashes and other orally consumable products, such as (at [0062]) a mouth wash. At Example 13 and [0105] on page 13 and accompanying Table 13, Yamasaki discloses a vanilla flavored mouthrinse comprising phenolic compounds and various flavors comprising decalactone delta, cyclohexyl lactone, natactone dextro (“dihydromintlactone”) and octalactone gamma.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Shi for Haught to use GSGs rather than unglucosylated natural steviol glycosides to improve its flavored products comprising high-intensity sweeteners. Both references disclose flavored products as oral care compositions having improved flavor and comprising high-intensity sweeteners and steviol glycosides. The ordinary skilled artisan in Haught would have desired to use GSGs as in Shi in its flavored products to further improve their taste profile, flavor intensity and mouthfeel.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Yamasaki for Haught as modified by Shi to include in its flavored product (a) a GSG; and (b) a combination of a lactones comprising (i) a dihydromintlactone; (ii) a lactone selected from the group consisting of butyrolactone gamma, valerolactone gamma, hexalactone gamma, heptalactone gamma, octalactone gamma, undecalactone gamma, decalactone gamma, dihydrojasmone lactone, and gamma nonalactone; and, (iii) a group of a 6-membered lactone without any unsaturated bonds selected from the group consisting of undecalactone delta, decalactone delta, dodecalactone delta, and cyclohexyl lactone. All references disclose flavored products as oral care compositions comprising high-intensity sweeteners and steviol glycosides; each of Haught and Yamasaki disclose flavored products further comprising flavoring or cooling compounds and a lactone comprising a 5-membered cyclic lactone ring. The ordinary skilled artisan in Haught as modified by Shi would have desired to include the claimed amount of the claimed combination of lactones as disclosed in Yamasaki to flavor its oral care flavored product and to eliminate odors in the composition. The Office considers the recited taste-modifying composition as including an odor-modifying composition used in a flavored product.
Regarding instant claims 18-19, Haught at [0029] discloses a total sweetener content of 0.001 wt% to 4 wt% (10 ppm to 40,000 ppm), which the claimed 5 to 500 ppm of a concentration of compounds of groups (a) and (b) in claim 18 overlaps and the claimed 10 to 300 ppm of a concentration of compounds of groups (a) and (b) in claim 19 lies within. See MPEP 2144.05.I. The Office interprets the term “concentration of compounds of groups (a) and (b)” as meaning the concentration of a high-intensity sweetener and all glucosylated or other natural steviol glycosides, not including a further sweetener of any kind.. Further, Haught at [0047]-[0049] discloses that its sweeteners comprise a ratio of 0.5-1 parts of a high-intensity sweetener to 0.5-1 parts of a further high-intensity sweetener, and 1-3 parts of natural steviol glycosides. Accordingly, the ordinary skilled artisan in Haught would have found it obvious to make a flavored product comprising the claimed a concentration of compounds of groups (a) and (b) because Haught discloses that the claimed amounts of such compounds makes a desirable flavored product.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over US2012/0082630 A1 to Haught et al. (Haught) in view of US2020/0138071 A1 to Shi et al. (Shi), both of record, and US20160000679 A1 to Yamasaki et al. (Yamasaki) as applied to claim 12 above, and further in view of US2009/0292010 A1 to Shigemura et al (Shigemura), of record.
As applied to claim 12 Haught at Abstract, [0039], Example IV at [0070] and the accompanying Table as modified by Shi at Abstract, [0892], Example 12 at [1300] and [1304] and accompanying Tables 12-1 and 12-2, and Example 13 at [1305] and [1308] and accompanying Tables 13-1 and 13-2 and Yamasaki at Abstract and Example 13, Table 13 and [0105] discloses a flavored product comprising a taste-modifying composition of hydrogen peroxide, (a) glucosylated natural steviol glycosides, and (b) a high-intensity sweetener, and combination of lactones including (i) a dihydromintlactone; (ii) a lactone selected from the group consisting of butyrolactone gamma, valerolactone gamma, hexalactone gamma, heptalactone gamma, octalactone gamma, undecalactone gamma, decalactone gamma, dihydrojasmone lactone, and gamma nonalactone; and, (iii) a group of a 6-membered lactone without any unsaturated bonds selected from the group consisting of undecalactone delta, decalactone delta, dodecalactone delta, and cyclohexyl lactone, wherein the amount of the taste-modifying composition is such that the total concentration of compounds of groups (a) and (b) ranges from 1 to 1000 ppm, based on the total weight of the flavored product.
Haught, Shi and Yamasaki do not disclose a 4-amino-5,6-dimethylthieno[2,3-d]pyrimidine-2(1H)-one or its salts.
Shigemura discloses sweetener compositions comprising sucralose and 4-amino-5,6-dimethylthieno[2,3-d]pyrimidine-2(1H)-one or its salts for use in (at [0052]) oral care products (“flavored product”) to provide (at [0026]) an improved sweetness delivery profile, wherein (at [0066]) the flavored product comprises about 0.001 to about 100 ppm of the compound 4-amino-5,6-dimethylthieno[2,3-d]pyrimidine-2(1H)-one or its salts and (at [0070]) the ratio of the compound to sucralose is from about 1:8 to about 1:20. At [0025], Shigemura discloses other sweeteners including high-intensity sweeteners and natural steviol glycosides.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Shigemura for Haught as modified by Shi and Yamasaki to include from 1 to 1000 ppm of a 4-amino-5,6-dimethylthieno[2,3-d]pyrimidine-2(1H)-one or its salts in its flavored product to improve its sweet flavor. Both references disclose oral care compositions comprising sucralose and other sweeteners having an improved flavor profile. The ordinary skilled artisan in Haught would have desired to include the 4-amino-5,6-dimethylthieno[2,3-d]pyrimidine-2(1H)-one or its salts in the claimed amounts along with its sweeteners as in Shigemura to improve its sweetness onset and lingering period.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over US2012/0082630 A1 to Haught et al. (Haught) in view of US2020/0138071 A1 to Shi et al. (Shi), both of record, and US20160000679 A1 to Yamasaki et al. (Yamasaki) as applied to claim 27 above, and further in view of US2018/0055069 A1 to Kulke et al. (Kulke), of record.
As applied to claim 27, Haught at Abstract, [0039], Example IV at [0070] and the accompanying Table as modified by Shi at Abstract, and Examples 12 and 13 and accompanying Tables 12-1 and 12-2, and 13-1 and 13-2 and Yamasaki at Abstract and Example 13, Table 13 and [0105] discloses a flavored product comprising a taste-modifying composition of hydrogen peroxide, (a) glucosylated natural steviol glycosides, and (b) a high-intensity sweetener, and combination of lactone, further comprising a cooling enhancing compound, wherein the amount of the taste-modifying composition is such that the total concentration of compounds of groups (a) and (b) ranges from 1 to 1000 ppm, based on the total weight of the flavored product.
Haught does not disclose the cooling enhancing compounds selected from the group consisting of: N-ethyl-N-(thiophen-2-ylmethyl)-2-(p-tolyloxy)acetamide; N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)-2-(p-tolyloxy)acetamide; 2-(4-fluorophenoxy)-N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)acetamide; 2-(2-hydroxy-4-methylphenoxy)-N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)-acetamide; 2-((2,3-dihydro-1H-inden-5-yl)oxy)-N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)-acetamide; 2-((2,3-dihydro-1H-inden-5-yl)oxy)-N-(1H-pyrazol-3-yl)-N-(thiazol-5-ylmethyl)-acetamide; and 2-((5-methoxybenzofuran-2-yl)oxy)-N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)-acetamide.
Kulke at Abstract discloses a composition comprising amides including (at [0049]-[0050] and [0053]) the claimed acetamides and aromatic substances that enable production of compositions having improved flavors and with improved shelf life, such as (at [0138]) oral care products, including (at [0267]) mouthwashes. At [0006], Kulke discloses that the amides (a) have a cooling effect; and, at [0049]-[[0050] and [0053] discloses particularly preferred amides as N-ethyl-N-(thiophen-2-ylmethyl)-2-(p-tolyloxy)acetamide, N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)-2-(p-tolyloxy)acetamide, and 2-((2,3-dihydro-1H-inden-5-yl)oxy)-N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)-acetamide. At [0131] Kulke discloses (b)(ii) aromatic substances including delta-decalactone, a 6-membered lactone without any unsaturated bonds, as well as gamma-decalactone, a 5-membered cyclic lactone ring and mixtures thereof. Further, Kulke at [0146] discloses a total amount of its components (a +b) of from 100 to 1000 ppm, based on the weight of its flavored products. And, at [0260] Kulke discloses high-intensity sweeteners and stevia extracts (“natural steviol glycosides”) in its oral care compositions.
Before the effective filing date of the present invention, the ordinary skilled artisan in Haught as modified by Shi and Yamasaki would have found it obvious in view of Kulke to include an amide which is N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)-2-(p-tolyloxy)acetamide, N-ethyl-N-(thiophen-2-ylmethyl)-2-(p-tolyloxy)acetamide or 2-((2,3-dihydro-1H-inden-5-yl)oxy)-N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)-acetamide in its taste-modifying composition. Both Haught and Kulke disclose acetamide containing taste-modifying compositions comprising cooling enhancing compounds for improving flavored products. The ordinary skilled artisan in Haught as modified by Shi and Yamasaki would have desired to include any of the acetamides of Kulke to enhance the cooling effect of its taste-modifying composition in a flavored product.
Response to Arguments
In view of the amendment dated April 28, 2026, the following rejections have been withdrawn as moot:
The rejections of claims 12-13 and 18-28 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite because the limitation "flavored composition" in line 9 of claim 12 lacks a sufficient antecedent basis; and,
The rejections of claims 23-24 and 27-28 under 35 U.S.C. 103 as being unpatentable over US2012/0082630 A1 to Haught et al. in view of US2020/0138071 A1 to Shi et al. and US2018/0055069 A1 to Kulke et al.
The positions taken in the remarks accompanying the amendment dated April 28, 2026 (Reply), the Office has fully considered the positions taken and does not find the positions persuasive for the following reasons:
Regarding the position taken that the art and cited references do not provide a person of ordinary skill in the art with any rationale for combining GSG and a high-intensity sweetener with a specific combination of lactones “to arrive at a flavored product having reduced off-taste due to the presence of hydrogen peroxide”, respectfully the fact that the inventor has recognized another advantage or intended use which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). By rule, the Office will only accord weight to an intended use feature to the extent that it results in a structural difference between the claimed method and that of the art. See MPEP 2111.02.II. the record provides no evidence of such a structural difference.
Regarding the position taken in the Reply and the alleged unexpected results comparing disclosed Sample 2 as an inventive example to Sample 1 as a comparative and referencing Table 2 of the instant specification, the comparison does not address the closest art of Haught at [0041]-[0042] includes at least a cooling enhancing compound for comparison.
Regarding the position taken in the Reply and the combination of Haught with Shi and Shigemura or Kulke, the position merely repeats positions already addressed and is taken as a general allegation of patentability. See 37 CFR 1.111(b).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW E MERRIAM whose telephone number is (571)272-0082. The examiner can normally be reached M-H 8:00A-5:30P and alternate Fridays 8:30A-5P.
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/ANDREW E MERRIAM/Examiner, Art Unit 1791
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