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 .
Applicants' arguments, filed 10/14/2021, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
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.
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.
New by Amendment
1) Claim(s) 1-4 and 6-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Purkayastha et al., (US 2014/0017378, cited in IDS).
Purkayastha et al. teaches a taste modifying composition comprising “a blend of glucosylated steviol glycosides and residual steviol glycosides which can modify the intensity of a taste and/or flavor in a food or beverage product” (Abstract), wherein food or beverage products include “toothpaste, mouthwash, cough syrup, chewable tablets, lozenges, vitamin preparations, and the like” (p. 3, para. [0043]).
The prior art describes a procedure where a “stevia extract with total steviol glycosides content between 75% and 99% is added to liquified starch” (p. 3, para. [0049]) and incubated with “CGTase (cyclomaltodextrin glucanotransferase) enzyme” to produce a solution of glucosylated steviol glycosides (GSG), residual steviol glycosides and maltodextrin (Id. para. [0053]) shown below:
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(Id). Here the prior art shows several compositions comprising enzymatically glucosylated steviol glycoside and rebaudioside A (Reb A), including where the enzymatically glucosylated steviol glycosides extract is comprised of 80 to 95% wt% glucosylated steviol glycosides with the remainder being steviosides and rebaudioside that don not react with the enzyme, as per claim 7.
The prior art also teaches:
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(p. 6, para. [0069]), showing a composition of 500ppm Reb A (rebaudioside A) and 120ppm of GSG-M, which provides a ratio of rebaudioside A to glucosylated steviol glycosides extract of 4.16:1, which falls within the claimed range of 1:4 to 5:1, as per claim 2.
The prior art teaches a composition comprising enzymatically glucosylated steviol glycoside and a rebaudioside A.
Purkayastha et al. does not teach how much of the sweetener to add to an oral care composition.
In regard to claims 1-4 and 6, it would have been obvious to modify a range for the sweeteners of Purkayastha et al. in oral care compositions based on taste, including ratios of rebaudioside A and glucosylated steviol glycosides.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.") (MPEP 2144.05IIA).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to adjust the amounts of the components in the compositions of Purkayastha et al. to fall within the broad ranges of the instant composition since this is simply routine optimization.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)).
Previous
2) Claim(s) 1-4, 6-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Purkayastha et al., (US 2014/0017378, cited in IDS) in view of Vemishetti et al., (US 2017/0128329).
Purkayastha et al. teaches a taste modifying composition comprising “a blend of glucosylated steviol glycosides and residual steviol glycosides which can modify the intensity of a taste and/or flavor in a food or beverage product” (Abstract), wherein food or beverage products include “toothpaste, mouthwash, cough syrup, chewable tablets, lozenges, vitamin preparations, and the like” (p. 3, para. [0043]).
The prior art describes a procedure where a “stevia extract with total steviol glycosides content between 75% and 99% is added to liquified starch” (p. 3, para. [0049]) and incubated with “CGTase (cyclomaltodextrin glucanotransferase) enzyme” to produce a solution of glucosylated steviol glycosides (GSG), residual steviol glycosides and maltodextrin (Id. para. [0053]) shown below:
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(Id). Here the prior art shows several compositions comprising enzymatically glucosylated steviol glycoside and rebaudioside A (Reb A), including where the enzymatically glucosylated steviol glycosides extract is comprised of 80 to 95% wt% glucosylated steviol glycosides with the remainder being steviosides and rebaudioside that don not react with the enzyme, as per claim 7.
The prior art also teaches:
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(p. 6, para. [0069]), showing a composition of 500ppm Reb A (rebaudioside A) and 120ppm of GSG-M, which provides a ratio of rebaudioside A to glucosylated steviol glycosides extract of 4.16:1, which falls within the claimed range of 1:4 to 5:1, as per claim 2. It would have been obvious to add these to oral care compositions, as per claims 19-21, since they are determined to be suitable blends for enhancing taste of a product
Purkayastha et al. does not teach how much of the sweetener to add to an oral care composition or typical oral care ingredients such as xylitol, stannous, zinc, arginine as per claims 1, 4, 6, 8-21.
In regard to claims 1-4 and 6, it would have been obvious to modify a range for the sweeteners of Purkayastha et al. in oral care compositions based on taste. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)).
However, Vemishetti et al. teaches, “Sweetening agent and coloring agents are generally used in toothpastes at levels of from 0.005 to 5%, by weight of the composition” (p. 5, para. [0065]). Accordingly, the claimed amounts of about 0.05 to about 3 wt%, from 0.1 to 1%, and from 0.1 to 1%, are prima facia obvious insofar as the fall withing the range disclosed by the prior art (see MPEP 2144.05).
The compositions of Vemishetti et al. further comprise “xylitol” which may fall within the disclosed range for sweetener, as per claim 8 (see p. 5, para. [0065]); one or more stannous compounds such as “stannous fluoride”, “stannous pyrophosphate” (p. 2, para. [0025]); zinc compounds and “mixtures thereof” including “zinc citrate”, “zinc oxide”, “zinc phosphate” (p. 6, para. [0088]); amino acids such as “arginine”, which may be present from “0.1% to 20% (expressed as weight of free base)”, as per claim 16 (p. 5, para. [0066]).
Accordingly, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to provide toothpaste compositions comprising combinations of zinc phosphate and stannous fluoride, as per claim 17; zinc phosphate, stannous fluoride, and stannous pyrophosphate, as per claim 18; zinc phosphate, stannous fluoride, and arginine, as per claim 19; zinc citrate and zinc oxide, as per claim 20; zinc citrate, zinc oxide, and arginine, as per claim 21.
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to combine the sweeteners of Purkayastha et al. with the toothpaste compositions of Vemishetti et al. since Purkayastha et al. teaches adding their sweeteners to a toothpaste. The adjustment of particular conventional working conditions of the combination of glucosylated steviol glycoside extract and rebaudioside A extract in a toothpaste (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Thus, it is within the purview of the artisan to determine result effective amounts of the ingredients beneficially taught by Purkayastha et al. and Vemishetti et al.
Response to Arguments
i) Applicant argues that the prior art does not teach the specific ratios or amounts of sweeteners recited in the claimed oral care composition (p. 7-9). Applicant postulates that because the sweeteners of Purkayastha et al. are high intensity sweeteners “one of skill in the art would not have expected steviol glycoside based sweeteners to be used in the 0.005% to 5% range reported in Vemishetti” (p. 8).
The Examiner disagrees.
It is well settled, “Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). No evidence has been presented in the prior art or by applicant proving that the artisan would not have reasonably expect efficacious sweeting within the range disclosed by Vemishetti.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
Applicant further argues that “the inventors found that toothpastes B-H formulated according to Tables 3-9 of the present application achieve not only consumer acceptable sweetness but also consumer acceptable bitterness” (p. 9). The instant specification further states, “the inventors have surprisingly discovered that a combination of rebaudioside A and one or more enzymatically glucosylated steviol glycosides extracts, can provide pleasant organoleptic properties and greatly reduce the negative attributes of rebaudioside A when the sweetener is incorporated within an oral care composition” (p. 2, para. [0007])
However, the artisan would have reasonably expected efficacious sweetening from the claimed combination of sweeteners insofar as Purkayastha et al. teaches “a blend of glucosylated steviol glycosides and residual steviol glycosides which can modify the intensity of a taste and/or flavor in a food or beverage product” (Abstract), wherein food or beverage products include “toothpaste, mouthwash (p. 3, para. [0043]). The blend is described as “a taste improver” (p. 1, para. [0009]). Following the suggestion of the prior art cannot be the basis for patentability. It must be remembered that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”. KSR Int’l Co. v. Teleflex Inc.,, 550 U.S. 398, 416 (2007).
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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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