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 .
Status of the Application
Receipt of the Response and Amendment after Final Office Action filed 07/24/2026 and the Request for Continued Examination (RCE under 37 CFR 1.114) filed 08/05/2026 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the claims and/or persuasive remarks: the 35 U.S.C. 112(b) rejection of claim 26 has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-3, 5, 9-11, 18, 19, 23, 26-30, 32, and 33
Withdrawn claims: None
Previously canceled claims: 4, 6-8, 12-17, 20-22, 24, 25, and 31
Newly canceled claims: None
Amended claims: 1
New claims: None
Claims currently under consideration: 1-3, 5, 9-11, 18, 19, 23, 26-30, 32, and 33
Currently rejected claims: 1-3, 5, 9-11, 18, 19, 23, 26-30, 32, and 33
Allowed claims: None
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 07/24/2026 has been entered.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1-3, 5, 9-11, 27-29, 32 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Prakash et al. (U.S. 2014/0099403 A1).
Regarding claim 1, Prakash et al. discloses a purified high-intensity sweetener comprising at least 95% by weight rebaudioside M (i.e., rebaudioside X), and also comprising rebaudiosides D, B, and A in a combined amount of less than 20,000 ppm but greater than 0 ppm for each individual steviol glycoside ([0236]).
Prakash et al. does not explicitly disclose rebaudioside D as being present in an amount greater than each of rebaudiosides B and A and in an amount of at least 40% of the combined amount of rebaudiosides D, B, and A.
However, the instruction in Prakash et al. that the steviol glycosides other than rebaudioside M may be a combination of rebaudiosides D, B, and A ([0236], [0242], [0248]) renders any concentrations of the other steviol glycosides obvious, including an embodiment wherein the concentration of rebaudioside D exceeds the amount of each of rebaudiosides B and A and also comprises at least 40% of the combined amount of rebaudiosides D, B, and A.
As for claims 2 and 3, the instruction in Prakash et al. that the steviol glycosides other than rebaudioside M may be a combination of rebaudiosides D, B, and A and where the rebaudioside M may be in an amount “greater than about 99%” ([0236], [0242], [0248]) renders any remaining concentrations of the other steviol glycosides obvious, including embodiments wherein the concentration of each is in an amount approaching (but not including) 0 ppm, which renders obvious the claimed ranges of less than 5000 ppm rebaudioside D, less than 4000 ppm rebaudioside B, and less than 2000 ppm rebaudioside A (claim 2) and less than 3200 ppm rebaudioside D, less than 2000 ppm rebaudioside B, and less than 1000 ppm rebaudioside A (claim 3).
As for claim 5, Prakash et al. discloses measuring the steviol glycosides using HPLC ([0203]).
As for claim 9, Prakash et al. discloses a sugar substitute comprising the purified high-intensity sweetener ([0531], [0534], [0535]).
As for claim 10, Prakash et al. discloses the sugar substitute as further comprising a bulking agent ([0531]).
As for claim 11, Prakash et al. discloses the bulking agent as being erythritol ([0532]).
Regarding claim 27, Prakash et al. discloses a method of making the sugar substitute of claim 9, the method comprising (i) combining rebaudioside X, water, and two bulking agents ([0531], [0532], [0537], [0600]) in a mixer ([0612]), (ii) mixing ([0601], “vigorous mechanical agitation”; [0602]), and (iii) drying the mixture ([0602], [0644]).
Prakash et al. does not specifically disclose adding a first bulking agent to a mixer, pre-coating the mixer with the first bulking agent, adding a second bulking agent and the purified high-intensity sweetener, and mixing those three ingredients before adding water.
However, MPEP 2144.04 IV C states: “Selection of any order of mixing ingredients is prima facie obvious.” Since no amount or type of either bulking agent is required, the claimed steps of adding a first bulking agent and precoating the mixer with that agent are considered to be inconsequential manipulative steps that do not patentably distinguish the claimed method from the disclosure of Prakash et al. Similarly, mixing the first three ingredients before a subsequent step of adding water is not considered to impart any patentable distinction to the claimed method, since (i) there is no requirement that water is omitted prior to the claimed step of adding water, (ii) no amount of water is required to be added at the noted step, and (iii) any order of adding ingredients is prima facie obvious. As such, the disclosure of Prakash et al. is considered adequate to deem the claimed method obvious.
As for claim 28, Prakash et al. discloses the first bulking agent may be erythritol ([0036], [0532]).
As for claim 29, Prakash et al. discloses the second bulking agent as being a soluble fiber ([0029], [0318], [0320], [0329], [0532], where fibers are disclosed as being suitable bulking agents).
As for claim 32, the instruction in Prakash et al. that the steviol glycosides other than rebaudioside M may be a combination of rebaudiosides, D, B, and A ([0236], [0242], [0248]) renders any concentrations of the other steviol glycosides obvious, including an embodiment wherein the concentration of rebaudioside A exceeds the amount of rebaudioside B.
As for claim 33, Prakash et al. discloses that a tabletop sweetener composition may comprise from about 1-10% w/w of rebaudioside M ([0535]), which overlaps and renders obvious the claimed range of about 0.1-1.0% by weight purified high-intensity sweetener (since no minimum amount of any steviol glycoside other than rebaudioside M is required and the purified high-intensity sweetener may thus be comprised of almost 100% rebaudioside M with infinitesimal amounts of rebaudiosides D, B, and A that still fall within the limitations of claim 1). Prakash et al. further discloses the bulking agent may be comprised of erythritol ([0036], [0532]), a soluble fiber ([0029], [0318], [0320], [0329], [0532]), “and mixtures thereof” ([0532]), which renders obvious any relative concentrations between bulking agents. The claimed concentrations of about 85-90% by weight erythritol and about 9-15% by weight soluble fiber are thus considered obvious to a skilled practitioner.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Galaev et al. (U.S. 2019/0194240 A1).
Regarding claim 1, Galaev et al. discloses a purified high-intensity sweetener composition comprising at least 95% by weight rebaudioside M (specifically, a purity of at least about 98% by weight on a dry basis of total steviol glycosides) ([0058]; where the composition may be dried [0065], such that the concentration on a dry weight basis would apply to a dried composition overall as well), and “one or more further steviol glycosides” ([0058]) that may be rebaudiosides D, B, and A ([0206]) in a combined amount of less than 20,000 ppm but greater than 0 ppm for each individual steviol glycoside ([0058], where “at least about 98% by weight on a dry basis of total steviol glycosides” of rebaudioside M would necessarily cause all the remaining steviol glycosides to be in a combined amount of less than 20,000 ppm).
Galaev et al. does not explicitly disclose rebaudioside D as being present in an amount greater than each of rebaudiosides B and A and in an amount of at least 40% of the combined amount of rebaudiosides D, B, and A.
However, the instruction in Galaev et al. of steviol glycosides other than rebaudioside M in a combination ([0058]) including rebaudiosides D, B, and A ([0206]) renders any concentrations of the other steviol glycosides obvious, including an embodiment wherein the concentration of rebaudioside D exceeds the amount of each of rebaudiosides B and A and also comprises at least 40% of the combined amount of rebaudiosides D, B, and A.
Claims 18, 19, 23, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Galaev et al. (U.S. 2019/0194240 A1) in view of Gokaraju et al. (U.S. 2010/0112101 A1).
Regarding claim 18, Galaev et al. discloses a method of preparing the purified high-intensity sweetener of claim 1 comprising (i) obtaining a cleared fermentation broth comprising rebaudioside M ([0161], [0149], [0202]), (ii) filtering the broth with an ultrafilter to generate an ultrafiltration permeate ([0066], [0067], [0203]), (iii) filtering the ultrafiltration permeate with a nanofilter to generate a nanofiltration flow-through ([0066], [0068], [0204]), (iv) washing the nanofiltration flow-through ([0205]), and (iv) spray-drying the washed nanofiltration flow-through to obtain the purified high-intensity sweetener ([0065], [0205]).
Galaev et al. does not specifically disclose the nanofilter as having a nanofiltration cutoff of greater than 300 Da up to 500 Da or using an acid solution to wash the nanofiltration flow-through.
Regarding the filter size, though, MPEP 2144.05 I states: “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”. Galaev et al. discloses the nanofilter as having a cutoff in the range of 150-300 Da ([0204]). Since the range are touch and the cutoff value would simply determine which size of molecules are excluded or retained by the nanofilter, the disclosed range is adequate to deem the claimed range obvious.
As for the acid wash, Gokaraju et al. discloses a method for producing a stevia extract comprising purified rebaudioside components, comprising filtering extracted material, wherein the pH of the material was adjusted to 11, further filtered, then neutralized back to pH 7 with citric acid ([0079]).
It would have been obvious to one having ordinary skill in the art to wash the nanofiltration flow-through with an acid solution. First, Galaev et al. discloses generally that the purification method may comprise “separating and washing the high purity composition comprising rebM” ([0073]). Although the reference provides some more specific instruction, the breadth of such initial instruction would prompt a skilled practitioner to consult Gokaraju et al. for further instruction. Since Gokaraju et al. discloses a method of purifying steviol extract material during and following filtration steps that involve raising the pH to 11 followed by neutralization to 7 with citric acid ([0079]), presumably to allow for finer control over the purification process, the claimed process step of washing the nanofiltration flow-through with an acid solution would be obvious to a skilled practitioner in order to likewise provide additional control over the purification process.
As for claim 19, Galaev et al. discloses the ultrafilter has a cutoff from about 2 kDa to about 100 kDa (specifically, from about 3 kDa to about 15 kDa) ([0067], [0203]).
As for claims 23 and 26, Gokaraju et al. discloses a method for producing a stevia extract comprising purified rebaudioside components, comprising filtering extracted material, wherein the pH of the material was adjusted to 11, further filtered, then neutralized back to pH 7 with citric acid ([0079]).
It would have been obvious to one having ordinary skill in the art to adjust the pH of the cleared fermentation broth to a pH greater than 7 (claim 23) and acidifying the filtered material with citric acid (claim 26). As discussed previously in relation to claim 18, Galaev et al. discloses generally that the purification method may comprise “separating and washing the high purity composition comprising rebM” ([0073]). Although the reference provides some more specific instruction, the breadth of such initial instruction would prompt a skilled practitioner to consult Gokaraju et al. for further instruction. Since Gokaraju et al. discloses a method of purifying steviol extract material during and following filtration steps that involve raising the pH to 11 followed by neutralization to 7 with citric acid ([0079]), presumably to allow for finer control over the purification process, the claimed process steps of adjusting the pH of the cleared fermentation broth to be greater than 7 (claim 23) and acidifying the nanofiltration flow-through with an acid solution that comprises citric acid (claim 26) would be obvious to a skilled practitioner in order to likewise provide additional control over the purification process.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Prakash et al. (U.S. 2014/0099403 A1) in view of De Brouwer et al. (U.S. 2008/0113075 A1).
Regarding claim 30, Prakash et al. discloses the method of claim 29 and further discloses that the composition may comprise dextrin ([0243], [0453], [0466]).
Prakash et al. does not specifically disclose the dextrin as being digestion resistant dextrin.
However, De Brouwer et al. discloses a confectionary composition comprising sugar substitute material including dextrin ([0015]) that may be Nutriose FM10 ([0028]).
It would have been obvious to one having ordinary skill in the art to use Nutriose FM10 as the dextrin material of Prakash et al. Since Prakash et al. discloses generally that the sweetener may comprise dextrin ([0243], [0453], [0466]) but does not disclose specific dextrin material, a skilled practitioner would be motivated to consult De Brouwer et al. for more detailed instruction. Since De Brouwer et al. discloses Nutriose FM10 as a dextrin for use in a sugar substitute material ([0015], [0028]), the incorporation of Nutriose FM10 into the composition of Prakash et al. would be obvious. Accordingly, the Nutriose FM10 would constitute digestion resistant dextrin, which renders the broader incorporation of digestion resistant dextrin into the composition of Prakash et al. obvious.
Response to Arguments
Claim Rejections - 35 U.S.C. § 112: Applicant has overcome the 35 U.S.C. § 112(b) rejection of claim 26 based on persuasive remarks. Accordingly, the 35 U.S.C. § 112(b) rejection has been withdrawn.
Claim Rejections - 35 U.S.C. § 103 of claims 1-3, 5, 9-11, 27-29, 32, and 33 over Prakash et al.: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant first argued that the new claim amendment addresses Examiner’s position at paragraph 57 of the previous Office Action that the claim 1 does not require any minimal amount of any of rebaudiosides D, B, or A by now requiring that rebaudioside D comprises at least 40% of the combined amount of rebaudiosides D, B, or A (Applicant’s Remarks, p. 2, ¶4). Applicant asserted that Prakash et al. does not teach or suggest the claimed profile, including any relative relationship between the claimed components (Applicant’s Remarks, p. 2, ¶5 – p. 5, ¶2).
The new claim limitation is of essentially no consequential limitation, since the concentration is in relation only to the total concentration of rebaudiosides D, B, and A. The claim still does not require any minimal amount of any of those components, does not require any perception of any of those components whatsoever, and does not require the exclusion of any other components that could modify taste/sweetness. The claim still encompasses a sweetener composition comprising primarily rebaudioside M and rebaudiosides D, B, and A in amounts so small that they would not even be perceived, along with any other steviol glycosides or other sweeteners in amounts approaching 5% by weight of the sweetener. The ratio between components that cannot even be perceived does not matter, in which case any relative ratio would be obvious. In light of such breadth of the claim, Examiner maintains that the disclosure of Prakash et al. is adequate to deem the newly-amended claim obvious. Further, paragraphs [0256]-[0258] of Prakash et al. disclose a rebaudioside X/rebaudioside D mixtures that may additionally contain rebaudiosides A or B, which further supports the obviousness of producing mixtures comprising such components in particular. Applicant’s arguments are unpersuasive.
The rejections of claims 1-3, 5, 9-11, 27-29, 32, and 33 have been maintained herein.
Claim Rejections - 35 U.S.C. § 103 of claim 1 over Galaev et al.; and claims 18, 19, 23, and 26 over Galaev et al. and Gokaraju et al.: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant argued that the new claim limitation addresses Examiner’s position at paragraph 70 of the previous Office Action that the claim 1 does not require any minimal amount of any of rebaudiosides D, B, or A by now requiring that rebaudioside D comprises at least 40% of the combined amount of rebaudiosides D, B, or A (Applicant’s Remarks, p. 6, ¶3; p. 7, ¶3 - ¶4).
The same rationale discussed previously in relation to Prakash et al. applies here as well, though, such that the new claim limitation is insufficient to necessitate withdrawing the claim rejection.
Applicant asserted that an example in Galaev et al. does not require a relative amount of components that fall within the scope of the present claim (Applicant’s Remarks, p. 6, ¶4 – p. 7, ¶2).
However, MPEP 2123 II states: “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” The broad disclosure of paragraph [0058] is thus adequate to deem the claimed relative concentrations of rebaudiosides D, B, and A obvious, based on their disclosure at paragraph [0206], even if the disclosed concentrations in the example do not overlap the claimed limitation.
Applicant argued that no specific instruction was identified in the prior art to arrive at the claimed relative concentrations of rebaudioside D, B, and A (Applicant’s Remarks, p. 7, ¶5 – p. 8, ¶4).
No additional instruction is necessary, though. Producing a composition according to Galaev et al. would necessitate selection of specific concentrations for each component. Applicant has merely require a subset of concentrations. Critically, though, no minimum amount of rebaudiosides D, B, or A is required and no effect of any those is required, which undermines Applicant’s arguments. It does not matter what the relative concentrations are where the components are not even necessarily perceived, in which case any relative concentrations would be obvious.
The rejections of claims 1, 18, 19, 23, and 26 have been maintained herein.
Conclusion
Claims 1-3, 5, 9-11, 18, 19, 23, 26-30, 32, and 33 are rejected.
No claims are allowed at this time.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
