DETAILED ACTION
Background
The amendment dated September 23, 2025 (amendment) amending claim 12, adding new claims 20-28 and canceling claims 1-8, 10-11 and 14-17 has been entered. Claims 12-13 and 18-28 as filed with the amendment have been examined. Claims 1-11 and 14-17 have been canceled.
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 .
Election/Restrictions
Applicant’s election without traverse of the invention of Group III, claims 12-13 and 18-19 as a flavored product in the reply filed on September 23, 2025 is acknowledged.
All non-elected claims have been canceled. Accordingly, no claims are withdrawn from consideration by the examiner.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The instant specification does not contain the subject matter of claim 28 which was presented in originally filed claim 7, now canceled.
Claim Objections
Claims 12 and 18-19 are objected to because of the following informalities:
In claim 12, at line 7 after “and any” make --combination
at line 9 before “from 1 ppm to” make --ranges-- plural;
In claim 18, at line 3 before “from 5 ppm to” make --ranges-- plural; and,
In claim 19, at line 3 before “from 10 ppm to” make --ranges-- plural.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 12-13 and 18-28 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 12 recites the limitation "flavored composition" in line 9. There is insufficient antecedent basis for this limitation in the claim. Do Applicants intend to refer to a flavored product?
The Office interprets the claim language as referring to a flavored product.
Claims 13 and 18-28 are rejected as depending from a rejected base claim.
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, 21-22 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), of record.
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 further sweetener in claim 21) and a rebaudioside (“natural steviol glycoside”) having an improved taste profile. 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) and water.
Further regarding instant claim 12, Haught does not disclose glucosylated natural steviol glycosides or GSGs.
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 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.
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.
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. 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. 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. 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) 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, 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 discloses a flavored product comprising a taste-modifying composition of hydrogen peroxide, (a) glucosylated natural steviol glycosides, and (b) a high-intensity sweetener, a lactone, a 4-amino-5,6-dimethylthieno[2,3-d]pyrimidine-2(1H)-one or its salts, or a combination thereof, 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 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 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.
Claims 23-24 and 27-28 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) as applied to claim 12 above, and further in view of US2018/0055069 A1 to Kulke et al. (Kulke).
As applied to claim 12 Haught at Abstract, 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 discloses a flavored product comprising a taste-modifying composition of hydrogen peroxide, (a) glucosylated natural steviol glycosides, and (b) a high-intensity sweetener, a lactone, a 4-amino-5,6-dimethylthieno[2,3-d]pyrimidine-2(1H)-one or its salts, or a combination thereof, 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 an amount of from 1 to 1000 ppm, based on the total weight of its flavored product, of total natural steviol glycosides and either a lactone in as in claim 23, or a lactone that is a 5-membered cyclic lactone ring as in claim 24; further, 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 as in claim 28, or a total amount of such cooling enhancing compounds plus natural steviol glycosides of 1 to 1000 ppm. 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 Haught as modified by 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.
Kulke at Abstract discloses preparations of amides and aromatic substances that enable production of compositions, such as (at [0138]) oral care products with improved shelf life, 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 (b2) aromatic substances including gamma-decalactone and gamma-dodecalactone, both of which comprise a 5-membered cyclic lactone ring. 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 would have found it obvious in view of Kulke for Haught as modified by Shi to include in its flavored product from 1 to 1000 ppm in total weight of a lactone that is a 5-membered cyclic lactone ring and 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. All references disclose flavored products as oral care compositions having comprising high-intensity sweeteners and steviol glycosides; each of Haught and Kulke 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 lactone as a 5-membered cyclic lactone ring and the claimed amount of the claimed cooling amides as in Kulke to flavor its oral care flavored product and to improve its shelf stability.
Conclusion
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