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 Non-Final Office Action filed 12/19/2025 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the claims and/or persuasive remarks: (1) the objection claim 22 has been withdrawn; (2) the 35 U.S.C. 112(b) rejection of claim 31 has been withdrawn; (3) the 35 U.S.C. 102(a)(1) rejections of claims 1-5 and 9-11 over Prakash et al. have been withdrawn; and (4) the 35 U.S.C. 102(a)(1) rejections of claims 1, 18, 19, 21, and 22 over Galaev et al. have been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-5, 9-11, 18, 19, 21-23, and 25-31
Withdrawn claims: None
Previously canceled claims: 6-8, 12-17, 20, and 24
Newly canceled claims: 4, 21, 22, 25, and 31
Amended claims: 1-3, 5, 18, 23, 26, and 27
New claims: 32 and 33
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
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.
Claim 26 is 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 26 recites the limitation “the acid solution” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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 rebaudiosides B and A, whether individually or combined.
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 combined amount of rebaudiosides 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).
Prakash et al. does not explicitly disclose rebaudioside D as being present in an amount greater than rebaudiosides B and A, whether individually or combined.
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 combined amount of rebaudiosides 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 Objections: Applicant has overcome the objection of claim 22 based on cancellation of the claim. Accordingly, the claim objection has been withdrawn.
Claim Rejections - 35 U.S.C. § 112: Applicant has overcome the 35 U.S.C. § 112(b) rejection of claim 31 based on cancellation of the claim. Accordingly, the 35 U.S.C. § 112(b) rejection has been withdrawn.
Claim Rejections - 35 U.S.C. § 102(a)(1) of claims 1-5 and 9-11 over Prakash et al.: Applicant has overcome the 35 U.S.C. § 102(a)(1) rejections of claims 1-5 and 9-11 based on amendment to the claims and/or cancellation. Accordingly, the 35 U.S.C. § 102(a)(1) rejections have been withdrawn.
Applicant’s arguments are addressed herein to the extent they may still be applicable to the present claim rejections under 35 U.S.C. § 103.
Applicant alleged claim 1 as presently amended “define a composition that is reproducibly distinct from the prior art” in that the relational profile between claimed steviol glycosides is achieved through the disclosed process sequence that includes nanofiltration and acid wash, where such a process is allegedly absent from the prior art (Applicant’s Remarks, p. 7, ¶4).
However, the claimed composition need not be produced by any particular method. The composition is merely a mixture of four steviol glycosides with some limits on concentrations. The composition may be produced by simply mixing purified steviol glycosides, which Examiner maintains is taught in the prior art. Applicant’s argument regarding the process for producing the claimed composition is thus unpersuasive in showing the composition should be deemed non-obvious.
Applicant argued that Prakash et al. does not disclose a “species-level presence of D, B, and A”, focusing extensively on the purification method of rebaudioside M disclosed in Prakash et al. (Applicant’s Remarks, p. 11, ¶4). Applicant argued that paragraph [0236] of Prakash et al. “describes a steviol glycoside mixture used as a component of a sweetener composition” (Applicant’s Remarks, p. 11, ¶5 – p. 12, ¶1). Applicant argued that the mixture of paragraph [0236] is not a “purified rebaudioside M ingredient as claimed” (Applicant’s Remarks, p. 12, ¶1).
Again, claim 1 is merely directed to a composition. The mixed composition of paragraph [0236] is adequate to deem the claimed composition obvious. The method of production is not considered in the patentability analysis. The word “purified” is not interpreted as meaning anything more than the sweetener may be considered to have undergone some degree of removal of undesirable contaminants. The word does not appear to have any narrower definition detailed in the specification. It is not interpreted as requiring the product to have been produced via some purification method, as opposed to being synthesized or simply be mixed from purified steviol glycoside components. Even if the term “purified” were interpreted as requiring production of the sweetener via a conventional purification process, the term would not still not limit the claimed composition, since the claimed would be examined as a product-by-process claim. MPEP 2113 I (“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.”).
Applicant’s argument regarding paragraph [0237] (where rebaudioside M may be a sole sweetener) (Applicant’s Remarks, p. 12, ¶2) are now moot since claim 1 has been amended to require the presence of rebaudiosides D, B, and A.
Applicant argued that paragraphs [0236]-[0237] “fail to disclose the specific relational and quantitative requirements of amended claim 1” (Applicant’s Remarks, p. 12, ¶3).
Examiner acknowledged that the disclosure of Prakash et al. would not support a rejection under 35 U.S.C. § 102(a)(1). The disclosure of Prakash et al. is adequate to deem the claim obvious, though.
Applicant alleged that “Prakash nowhere discloses these secondary rebaudiosides individually, nor any quantitative limits or relationships among them” (Applicant’s Remarks, p. 12, ¶4). Applicant alleged that “Prakash discloses impurities only as a generic ‘total steviol glycosides’” (Applicant’s Remarks, p. 13, ¶1).
However, paragraph [0236] clearly recites all of rebaudiosides D, B, and A and indicates they may be part of a mixture along with rebaudioside M. The mixture does not consider rebaudiosides D, B, and A to be impurities that are characterized only as part of an overall impurity grouping but instead treats them as intentionally-added components. Paragraphs [0242] and [0248] confirm this reading of the disclosure of Prakash et al. that rebaudioside compounds may be combined to form a mixed sweetener composition.
Applicant next argued that Prakash et al. does not disclose any relational profile among rebaudiosides D, B, and A (Applicant’s Remarks, p. 13, ¶2).
The updated claim rejection acknowledges this deficiency yet nonetheless determines the claimed composition would be obvious under 35 U.S.C. § 103. The scope of the claim, which does not require any minimal amount of any of rebaudiosides D, B, or A, does not require the perception of any of those steviol glycosides whatsoever—whether directly or as taste/sweetness modifiers, and does not require the exclusion of any other components that could modify taste/sweetness, further weighs in favor of determining that the claimed composition requiring only the presence of four steviol glycosides according to some concentration limitations would be obvious.
Applicant then argued that Prakash et al. does not disclose that the combined amount of rebaudiosides D, B, and A is less than 20,000 ppm (Applicant’s Remarks, p. 13, ¶3). Applicant argued that “[t]here is no disclosure that D, B, and A are the only impurities” (Applicant’s Remarks, p. 14, ¶1).
Paragraph [0236] of Prakash et al. indicates the rebaudioside M concentration may be “greater than about 99%”, which means all of the remaining components would be less than about 1%, which falls within the scope of the claimed limitation of less than 20,000 ppm (i.e., 2%). The claim does not require the exclusion of any other steviol glycosides or any components whatsoever, which may thus be present in the composition. That is, there is no requirement that rebaudiosides D, B, and A are the only additional components beyond rebaudioside M.
Applicant then argued that Prakash et al. provides minimal instruction regarding components other than rebaudioside M (Applicant’s Remarks, p. 14, ¶2).
Applicant’s arguments appear to be only within the context of producing a purified rebaudioside M component that still comprises some amount of unidentified steviol glycoside impurities. The claim rejections, though, rely on simply mixing a pure rebaudioside M ingredient with three other pure ingredients—rebaudiosides, D, B, and A. Examiner maintains that the disclosure of Prakash et al. supports such a reading of the reference. Applicant’s arguments pertaining to the identity of components in a total steviol glycoside impurity mixture are thus not directly relevant to the present claim rejection.
Applicant next argued that inherency cannot properly form the basis for rejecting the claimed limitations regarding rebaudiosides D, B, and A (Applicant’s Remarks, p. 14, ¶3 – p. 15, ¶1). Applicant alleged that Prakash et al. aims to remove as many non-rebaudioside M glycosides as possible (Applicant’s Remarks, p. 15, ¶2).
However, the present claim rejection does not rely on any inherency rationale, which undermines Applicant’s argument. Further, Prakash et al. is not limited to only producing compositions that comprise rebaudioside M with as little secondary impurities as possible. The reference teaches mixtures of steviol glycosides ([0236], [0242], [0248]). Applicant’s arguments are thus unpersuasive.
Claim Rejections - 35 U.S.C. § 102(a)(1) of claims 1, 18, 19, 21, and 22 over Galaev et al.: Applicant has overcome the 35 U.S.C. § 102(a)(1) rejections of claims 1, 18, 19, 21, and 22 based on amendment to the claims and/or cancellation. Accordingly, the 35 U.S.C. § 102(a)(1) rejections have been withdrawn.
Applicant’s arguments are addressed herein to the extent they may still be applicable to the present claim rejections under 35 U.S.C. § 103.
Applicant argued that the starting material between Galaev et al. and the present application are different, citing a “claimed clearing step” as having a definition in the specification (Applicant’s Remarks, p. 16, ¶2). Applicant asserted the differing process parameters and separation contexts would result in different starting materials that would not predictably produce the same results. Id.
However, the patentability analysis is of the method that is claimed, not the method recited in the specification. Claim 18 does not even require a clearing step; it merely requires “obtaining a cleared fermentation broth comprising rebaudioside M”, with no limits regarding the degree of clearing, the nature of the fermentation, or the concentration of any component, including rebaudioside M. The claim does not require the exclusion of any process steps or any extraneous addition of any steviol glycosides. The claim does not require any effect to be achieved by any of the ultrafiltration, nanofiltration, washing, or spray-drying steps beyond the production of a separated byproduct stream from each step. The claim does not require the “cleared fermentation broth comprising rebaudioside M” to be unprocessed prior to initiation of the claimed method; the “cleared fermentation broth” may be manipulated to already comprise steviol glycoside concentrations that fall within the scope of the limitations of claim 1. The claimed process thus does not amount to anything more than a series of conventional separation steps, which were shown to be known in the art.
Applicant’s arguments regarding the alleged differences between the process of Galaev et al. and the process of the present application are unpersuasive due to the substantial difference in scope between the method that is actually claimed and the method referred to by Applicant that is described in the specification.
Applicant next argued that Galaev et al. does not disclose the claimed compositional limitations of the respective steviol glycosides (Applicant’s Remarks, p. 16, ¶3 – p. 17, ¶2).
As detailed in the updated claim rejection, Galaev et al. discloses the composition may comprise steviol glycosides other than rebaudioside M ([0058]) and lists rebaudiosides D, B, and A as such steviol glycosides ([0206]). The claimed concentrations of rebaudiosides D, B, and A were determined to be obvious according to the rationale in the claim rejection, including relative concentrations. The absence of any minimum amount of any of rebaudiosides, D, B, or A, or requirement for any effect to occur undermines any assertion of criticality as related to the “relational dominance” of rebaudioside D over rebaudiosides B and A. Any concentrations of the other steviol glycosides obvious within the limit of constituting only about 2% or less of total steviol glycosides due to the presence of at least 98% by weight rebaudioside M ([0058]).
Applicant argued that the broad ranges are insufficient to anticipate or render obvious the claimed secondary steviol glycoside profile (Applicant’s Remarks, p. 17, ¶3).
Examiner maintains that the updated claim rejections adequately address the claimed concentrations, which are properly deemed obvious.
Applicant next argued that the clearing step disclosed in the specification is material in that it reduces fouling, improves membrane selectivity, and enables controlled retention of secondary steviol glycosides (Applicant’s Remarks, p. 17, ¶4 – p. 18, ¶1).
Again, claim 1 does not require a clearing step per se. The present specification does not appear to provide any definition of “clearing” or “cleared” as asserted by Applicant. The closest description appears to be in Example 3, which states: “The diluted fermentation broth was then centrifuged to separate the biomass and solids from the RebM containing supernatant phase (cleared fermentation broth).” (p. 43, ll. 10-12). Even if such a process may result in a composition deemed a “cleared fermentation broth”, such description does not provide substantive limits on what may or may not fall within the scope of a “cleared fermentation broth”. The limits now asserted by Applicant are not described in the specification in a manner sufficient to implicitly require some additional limitation on the term in claim 18.
Paragraph [0149] of Galaev et al. does not recite the statement Applicant attributes to that paragraph, and the document overall does not appear to recite the quote elsewhere either. Galaev et al. also does not appear to recite “coarse filtration”. For all these reasons, the asserted distinctions between the claimed method and the prior art are insufficient to overcome the obviousness determination for the claimed method.
Applicant next argued that the claimed nanofiltration cutoff is critical to achieving the claimed steviol glycosides profile (Applicant’s Remarks, p. 18, ¶2). Applicant asserted that the disclosed range of 150-300 Da in Galaev et al. does not overlap the claimed range of greater than 300 Da to 500 Da (Applicant’s Remarks, p. 18, ¶3).
However, the method claimed in claim 18 is not limited to consisting of only the claimed steps, which effectively disconnects the method from the sweetener of claim 1 in the sense that additional steps may be performed in order to achieve the sweetener of claim 1. Specifically, any components may be added immediately prior to the spray drying step. The starting “cleared fermentation broth” may also be manipulated prior to initiation of the claimed method to already comprise the necessary steviol glycoside profile. Given the breadth of the claimed method, again, it is effectively reduced to merely requiring the performance of conventional separation steps, which is properly deemed obvious in view of the prior art.
The disclosed cutoff range of 150-300 Da is adequate to deem the claimed range of greater than 300 Da to 500 Da obvious, since the ranges touch. Further, no appreciable difference would be observed in terms of separation of components having molecular masses nowhere near the threshold of 300 Da for a membrane having a cutoff of 300 Da or “greater than 300 Da”.
Applicant then argued that Galaev et al. is directed to reducing steviol glycosides other than rebaudioside M as opposed to retaining such components (Applicant’s Remarks, p. 19, ¶1).
Again, achieving the steviol glycoside profile of claim 1 does not have to be directly via the method of claim 18, since the claimed method is not limited to excluding additional processing steps. Also, Galaev et al. discloses the inclusion of other steviol glycosides ([0058]), which contradicts Applicant’s argument.
Applicant next argued again that Galaev et al. does not disclose a “cleared broth” as required by claim 18 (Applicant’s Remarks, p. 19, ¶2 – p. 20, ¶1).
As discussed previously herein, Examiner maintains that the disclosure of Galaev et al. is adequate to deem the method that is actually claimed obvious. The implied limitations on a “cleared fermentation broth” do not appear in the specification in a manner that would necessarily limit the term in claim 18. Also, Galaev et al. disclose centrifugation of the mixture ([0053], [0202]) such that it unclear how the asserted step of clearing that merely requires centrifugation or filtration would be distinct from the disclosure of Galaev et al. Applicant’s argument remains unpersuasive.
Applicant next argued that Galaev et al. contradicts the claimed profile based on the data in Example 1, Table 3 (Applicant’s Remarks, p. 20, ¶2). Applicant alleged that Galaev et al. teaches away from and “is silent on sensory consequences” (Applicant’s Remarks, p. 20, ¶3). Applicant asserted that that varying sweetness profiles of steviol glycosides necessitates individual consideration of the contribution of each steviol glycoside (Applicant’s Remarks, p. 21, ¶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 broader disclosure of Galaev et al. states: “the high purity composition comprising rebM may comprise one or more further steviol glycosides”, where rebaudioside M may constitute “at least about 98% by weight on a dry basis of total steviol glycosides” ([0058]). The broader disclosure is thus adequate to deem the claimed profile of secondary steviol glycosides obvious. The table in Example 1 is however relied on as disclosing that rebaudiosides D, B, and A in particular may comprise such secondary steviol glycosides but it is not relied on for concentration limitations. Applicant’s arguments regarding the sensory consequences of individual steviol glycosides are narrower in scope than the present claims, which do not require any minimum amount of any of rebaudiosides D, B, or A and do not require any effect to be perceived, which undermines Applicant’s position. Applicant’s arguments are thus unpersuasive.
For the method of claim 18, Applicant noted distinctions in the nanofiltration cutoff and the wash solution between Galaev et al. and the claimed method (Applicant’s Remarks, p. 21, ¶3).
Again, the scope of the claim is broader than Applicant’s arguments, which renders the arguments unpersuasive. The method of claim 18 does not require any specific profile for the starting material, does not require any effect to occur from any of the claimed processing steps, and does not require the exclusion of any additional process steps, such s simply modifying the steviol glycoside profile via addition of pure components as desired in the step prior to spray drying. Given the disparity between Applicant’s arguments and the scope of the claimed method, the arguments are unpersuasive. Examiner maintains that the method that is actually claimed would be obvious in view of the cited prior art.
Claim Rejections - 35 U.S.C. § 103 of claims 23, 25, and 26 over Galaev et al. and Gokaraju et al.: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant again alleged that “cleared fermentation broth” is expressly defined in the specification (Applicant’s Remarks, p. 22, ¶2).
As discussed previously herein, though, the term does not appear to be defined in the specification in the manner asserted by Applicant. Examiner thus maintains that the term is properly accounted for in the present claim rejections and that it does not implicitly require some limitation that the prior art does not disclose.
Applicant next argued that Gokaraju et al. is non-analogous art due to allegedly being limited to “bulk stevia extracts” (Applicant’s Remarks, p. 22, ¶3– p. 23, ¶1).
However, MPEP 2141.01(a) states: “A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention).” For simplicity, the field of art may be fairly characterized as simply being stevia extract products and methods, which both Gokaraju et al. and the claimed invention would fall within, such that Gokaraju et al. is thus properly relied on as analogous prior art. Examiner does not concede that the field of art is that narrow, though; it could also reasonably be defined as “natural sweeteners”, “sugar substitutes”, “extraction methods for natural products”, or simply even “edible food additives”. The very limited definition asserted by Applicant improperly narrows what would reasonably be considered the field of art.
Applicant next argued that acid washing should be considered to be equivalent to pH adjustment, since Gokaraju et al. teaches the addition of mineral acids that would perform differently than citric acid (Applicant’s Remarks, p. 23, ¶2-¶3).
However, Applicant’s arguments are narrower than the method that is actually claimed, which undermine the arguments. The claimed step of “washing the nanofiltration flow-through with an acid solution” does not require any particular acid (and claim 26 is not limited to citric acid alone), does not require any degree of acidity, does not require any degree of pH change, and does not require any effect to occur. The step is viewed as essentially nothing beyond simply contacting the nanofiltration flow-through with an acid solution. Examiner maintains that the combination of Galaev et al. and Gokaraju et al. is adequate to deem the claimed step obvious.
Applicant then argued that Gokaraju et al. does not disclose pH adjustment of a cleared broth or pH adjustment above 7, since it is directed to crude extract processing (Applicant’s Remarks, p. 23, ¶4 – p. 24, ¶1).
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains that the combined instruction of Galaev et al. and the limited additional instruction relied on in Gokaraju et al. is adequate to deem the claimed acid wash and pH adjustment steps obvious. Again, the breadth of the claims weighs in favor of obviousness, since no specific acid or effect is required and no specific pH above 7 is required (i.e., the claim includes a pH of 7.01 that would not be expected to materially affect separation of components).
Applicant next asserted that the prior art references teach away from the claimed invention, as well as there being a lack of any reasonable expectation of success in yielding the claimed method or claimed composition (Applicant’s Remarks, p. 24, ¶3 – p. 25, ¶1).
Applicant’s arguments are unpersuasive due to being substantially narrower in scope than the presently-claimed method, which does not require any specific steviol glycoside profile in the starting material, does not require any effect to occur at any of the claimed steps, and does not require the exclusion of any other process steps that may manipulate the steviol glycoside concentrations. Examiner maintains that the method that is actually claimed would be obvious to a skilled practitioner and that there would be a reasonable expectation of success in simply purifying to some degree, in any manner in terms of which components are removed, a starting “cleared” fermentation broth.
The rejections of claims 23 and 26 have been maintained herein.
Claim Rejections - 35 U.S.C. § 103 of claims 27-29 over Prakash et al.: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant first argued that claim 27 should not be deemed obvious since it ultimately depends from claim 1, which Applicant contends is not properly rejected (Applicant’s Remarks, p. 25, ¶2).
Examiner maintains that claims 1 and 9 were properly rejected and that claim 27 likewise is rejected with adequate support noted in the prior art. The scope of the claims is broader than the basis for Applicant’s arguments, which renders the arguments unpersuasive.
Applicant next argued that specific sequence of steps in claims 27-29 is not taught or suggested by Prakash et al., again asserting that Prakash et al. treats all steviol glycosides other than rebaudioside M as an overall impurity group (Applicant’s Remarks, p. 25, ¶3 – p. 26, ¶1). Applicant alleged that the claimed process “yields functional, physical, and sensory outcomes (e.g., coating uniformity, particle morphology, flowability, taste release, and stability) that are not achieved merely by listing bulking agents” (Applicant’s Remarks, p. 26, ¶2).
The claim rejection acknowledges that 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, the steps were determined to nonetheless be obvious according to the rationale detailed in the claim rejection.
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies (i.e., functional, physical, and sensory outcomes, including coating uniformity, particle morphology, flowability, taste release, and stability) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). While the method performed by Applicant may promote or facilitate materialization of those desired attributes, the presently-claimed method does not require any such attributes to occur. For example, the claimed method does not require the purified high-intensity sweetener to have any particular morphology, flowability, taste release (which would be determined in part by the relative amounts of bulking agents and sweetener), or stability. The claimed method merely requires a sequence of steps that were determined to amount to no more than an ingredient-addition sequence that was insufficient to patentably distinguish the claimed method from the prior art.
Applicant next alleged that the disclosure of bulking agents in Prakash et al. is insufficient as related to the claimed sequence of process steps (Applicant’s Remarks, p. 26, ¶3). Applicant asserted that because Prakash et al. allegedly does not disclose “the required purified ingredient” then no method using it may be deemed obvious (Applicant’s Remarks, p. 26, ¶4 – p. 27, ¶1).
The claimed sequence of steps was determined to be obvious based on the rationale detailed in the claim rejection. Examiner maintains that the disclosure of Prakash et al. is adequate for all that is relied on in the claim rejection. The mere disclosure of bulking agents is not exclusively relied on for deeming the claimed process obvious. Examiner further maintains that Prakash et al. is adequate to deem the composition of claim 1 obvious, which undermines Applicant’s argument regarding the non-obviousness of a method using such a composition. Applicant’s arguments are thus unpersuasive.
The rejections of claims 27-29 have been maintained herein.
Claim Rejections - 35 U.S.C. § 103 of claims 30 and 31 over Prakash et al. and De Brouwer et al.: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant again argued that because Prakash et al. allegedly does not disclose “the purified high-intensity sweetener of claim 1” then no method using it may be deemed obvious (Applicant’s Remarks, p. 27, ¶2). Applicant asserted that the present specification links the claimed secondary rebaudioside profile “to unexpected taste and performance benefits” and alleged criticality of the acid wash and membrane selection (Applicant’s Remarks, p. 27, ¶3).
Examiner maintains that Prakash et al. is adequate to deem the composition of claim 1 obvious, which undermines Applicant’s argument regarding the non-obviousness of a method using such a composition. The scope of the claims is broader than the asserted data, which is consequently insufficient to overcome the prima facie showing of obviousness. MPEP 716.02(d). At the least, the claims do not require (i) any minimal amount of any of rebaudiosides D, B, or A, (ii) the perception of any of those ingredients, or (iii) the exclusion of additional components that would modify the sweetness/taste profile. Similarly, the acid wash and “membrane selection” limitations are too broad to support any assertion of criticality. Applicant’s arguments are thus unpersuasive.
The rejection of claim 30 has been maintained herein.
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.
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
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