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 Request for Continued Examination (RCE under 37 CFR 1.114), the Response and Amendment filed 04/22/2026 is acknowledged.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-4
Withdrawn claims: None
Previously canceled claims: None
Newly canceled claims: None
Amended claims: 1 and 3
New claims: None
Claims currently under consideration: 1-4
Currently rejected claims: 1-4
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/22/2026 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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Giovanetto (U.S. 4,892,938) and admitted prior art, as evidenced by Payzant et al. (U.S. 5,962,678).
Regarding claim 1, Giovanetto discloses a process for preparing a steviol glycoside composition (C1, L6-L9), the process comprising the steps of (i) providing Stevia rebaudiana leaves (C2, L33-L36) (where Payzant et al. confirms the plant material of Giovanetto is leaves, C1, L40; C3, L42-L46, L52-L53; C4, L50-L51), (ii) providing a solvent comprising water (C1, L47-L48), (iii) contacting the Stevia rebaudiana leaves with the solvent to extract the steviol glycosides from the leaves (C1, L52-L55; C2, L33-L36); and (iv) separating the Stevia rebaudiana leaves to obtain a Stevia extract solution (C1, L56-L57; C2, L36-L41) comprising at least two steviol glycoside (where Payzant et al. confirms the “sweet glycosides obtained from Giovanetto process are always a mixture”, C1, L64-L65).
Giovanetto does not explicitly disclose the leaves or the extract solution as comprising at least two steviol glycosides that are from the group of RebD, RebE, RebN or RebO, wherein such steviol glycosides are present in the extract solution at or above their common relative concentrations of 2.4% (RebD), 1.0% (RebE), 1.6% (RebN) or 0.8% (RebO).
However, the present specification admits that the common relative concentration “refers to the relative concentration of steviol glycosides occurring in known varieties and untreated aqueous extracts of Stevia rebaudiana plants” (P3, L20-L21).
It would have been obvious to one having ordinary skill in the art to perform the extraction method of Giovanetto on known varieties of Stevia rebaudiana plants as admitted in the specification, such that the starting leaves would inherently comprise at least two of the claimed steviol glycosides at or above their common relative concentrations and the resultant extract solution would likewise contain such steviol glycosides in amounts at or above their common relative concentration. First, Giovanetto discloses simply that the method is useful for “recovery of steviosides from dried plant raw material of Stevia rebaudiana Bertoni by extraction and purification” (C1, L6-L9). A skilled practitioner would recognize that the method would be suitable for the extraction of steviol glycosides from any known variety of Stevia rebaudiana plant containing such components. Since the present specification admits that varieties having a common relative concentration at the claimed amounts for RebD, RebE, RebN and RebO are known varieties, extracting such plant varieties according to the method of Giovanetto would also be obvious. Further, since no fractionation or separation of the glycosides occurs in the extraction method of Giovanetto (Payzant et al., C1, 64-L65; C2, L15-L17, “the resulting materials contain a mixture of all of the sweet glycosides”), the relative concentration of any particular steviol glycoside would be at or above its common relative concentration. Thus, providing Stevia rebaudiana leaves that comprise at least two of RebD, RebE, RebN or RebO that are at or above their common relative concentration and performing a water extraction to obtain a stevia extract solution comprising at least two of 2.4% RebD, 1.0% RebE, 1.6% RebN or 0.8% RebO would be obvious to a skilled practitioner.
As for claim 2, Giovanetto discloses the process as further comprising purification of the stevia extract solution and drying to obtain a stevia extract (C2, L36-L53) with total steviol glycoside content of at least 6.9% w/w (specifically, about 75% steviosides) (C2, L54).
As for claim 3, Giovanetto discloses the stevia extract as being an “untreated aqueous Stevia extract” (which the present specification defines as being “an extract or extracts from Stevia rebaudiana plants that has or have not been subjected to techniques used to purify, isolate or further concentrate a certain steviol glycoside, or a group of steviol glycosides, from the extract”, P3, L22-L25), since the stevia extract is not subject to any method that would further purify, isolate of concentrate a specific steviol glycoside or select group of steviol glycosides (C2, L33-L54; Payzant et al., C1, L64-L65; C2, L15-L17). Since no fractionation or separation of the glycosides occurs in the extraction method of Giovanetto, the relative concentration of any particular steviol glycoside, including all of RebD, RebE, RebN and RebO, in the stevia extract would be at or above its common relative concentration.
As for claim 4, Giovanetto discloses a food comprising the stevia extract (C1, L12-L14).
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Giovanetto (U.S. 4,892,938) and Brower et al. (WO 2014/146084 A1), as evidenced by Payzant et al. (U.S. 5,962,678).
Regarding claim 1, Giovanetto discloses a process for preparing a steviol glycoside composition (C1, L6-L9), the process comprising the steps of (i) providing Stevia rebaudiana leaves (C2, L33-L36) (where Payzant et al. confirms the plant material of Giovanetto is leaves, C1, L40; C3, L42-L46, L52-L53; C4, L50-L51), (ii) providing a solvent comprising water (C1, L47-L48), (iii) contacting the Stevia rebaudiana leaves with the solvent to extract the steviol glycoside from the leaves (C1, L52-L55; C2, L33-L36); and (iv) separating the Stevia rebaudiana leaves to obtain a Stevia extract solution (C1, L56-L57; C2, L36-L41) comprising at least one steviol glycoside (where Payzant et al. confirms the “sweet glycosides obtained from Giovanetto process are always a mixture”, C1, L64-L65).
Giovanetto does not explicitly disclose the leaves or the extract solution as comprising at least two steviol glycoside that are from the group of RebD, RebE, RebN or RebO, wherein such steviol glycosides are present in the extract solution at or above their common relative concentration of 2.4% (RebD), 1.0% (RebE), 1.6% (RebN) or 0.8% (RebO).
However, Brower et al. discloses that plants may be high RebD and high RebN (p. 2, ¶7). Brower et al. discloses a Stevia rebaudiana plant that has been enriched to contain RebD in an amount as high as 3% (pp. 3-4, bridging paragraph). Brower et al. discloses a Stevia rebaudiana plant that has been enriched to contain RebN in an amount as high as 2% (p. 5, ¶4).
It would have been obvious to one having ordinary skill in the art to perform the extraction method of Giovanetto on a Stevia rebaudiana plant as disclosed in Brower et al. that is both high RebD and high RebN, such that the starting leaves would comprise RebD in an amount of as high as 3% and RebN in an amount of as high as 2% and the extract solution would likewise comprise RebD and RebN in comparable amounts. First, Giovanetto discloses simply that the method is useful for “recovery of steviosides from dried plant raw material of Stevia rebaudiana Bertoni by extraction and purification” (C1, L6-L9). A skilled practitioner would recognize that the method would be suitable for the extraction of steviol glycosides from any known variety of Stevia rebaudiana plant containing such components. Since Brower et al. discloses the concentration of RebD in Stevia rebaudiana plants may be as high as 3% (pp. 3-4, bridging paragraph) and the concentration of RebN in Stevia rebaudiana plants may be as high as 2% (pp. 5, ¶4), extracting a plant having a common relative concentration of RebD of at least 2.4% and of RebN of at least 1.6% according to the method of Giovanetto would be obvious. Further, since no fractionation or separation of the glycosides occurs in the extraction method of Giovanetto (Payzant et al., C1, 64-L65; C2, L15-L17, “the resulting materials contain a mixture of all of the sweet glycosides”), the relative concentration of any particular steviol glycoside would be at or above its common relative concentration. Thus, providing Stevia rebaudiana leaves that comprise RebD and RebN that are at or above their common relative concentration and performing a water extraction to obtain a stevia extract solution comprising at least 2.4% RebD and at least 1.6% RebN would be obvious to a skilled practitioner.
As for claim 2, Giovanetto discloses the process as further comprising purification of the stevia extract solution and drying to obtain a stevia extract (C2, L36-L53) with total steviol glycoside content of at least 6.9% w/w (specifically, about 75% steviosides) (C2, L54).
As for claim 3, Giovanetto discloses the stevia extract as being an “untreated aqueous Stevia extract” (which the present specification defines as being “an extract or extracts from Stevia rebaudiana plants that has or have not been subjected to techniques used to purify, isolate or further concentrate a certain steviol glycoside, or a group of steviol glycosides, from the extract”, P3, L22-L25), since the stevia extract is not subject to any method that would further purify, isolate of concentrate a specific steviol glycoside or select group of steviol glycosides (C2, L33-L54; Payzant et al., C1, L64-L65; C2, L15-L17). Since no fractionation or separation of the glycosides occurs in the extraction method of Giovanetto, the relative concentration of any particular steviol glycoside, including all of RebD, RebE, RebN and RebO, in the stevia extract would be at or above its common relative concentration.
As for claim 4, Giovanetto discloses a food comprising the stevia extract (C1, L12-L14).
Double Patenting
Claims 1, 3, and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,230,567 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claim is simply broader than that of the ‘567 patent due to lacking specific cultivars.
Claim 3 would be obvious in view of claim 1 of the ‘567 patent due to being the product produced by the patented process.
Claim 4 would be obvious in view of claim 1 of the ‘567 patent due to being the product produced by the patented process, where being a “consumable comprising the Stevia extract” does not impart any additional appreciable limitation beyond what is claimed in claim 3.
Response to Arguments
Claim Rejections - 35 U.S.C. § 103 of claims 1-4 over Giovanetto, admitted prior art, and Payzant et al.: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant first argued that Giovanetto discloses the recovery of “steviosides” but not the claimed rebaudiosides (Applicant’s Remarks, p. 4, ¶4).
However, Giovanetto discloses that “[s]teviosides are used as serviceable artificial sweeteners and are added to low-calorie foods or as replacement for natural sugar” (C1, L12-L14). A skilled practitioner would readily recognize that “steviosides” refers to steviol glycosides routinely obtained from the Stevia rebaudiana, which would include all of the claimed steviol glycosides, as well as all of the other steviol glycosides that naturally occur in the plant. Payzant et al. discloses “[t]he sweet glycosides obtained from Giovanetto process are always a mixture” and that there are many minor sweet glycosides (C1, L64 – C2, L1). The extracted material of Giovanetto would thus comprise the claimed steviol glycosides. Further, present claim 1 merely requires the steviol glycosides to be present at their common relative concentration. The present specification admits that the common relative concentration “refers to the relative concentration of steviol glycosides occurring in known varieties and untreated aqueous extracts of Stevia rebaudiana plants” (P3, L20-L21). As written, then, claim 1 requires nothing more than a conventional extraction of Stevia rebaudiana plants.
Applicant argued that Payzant et al. discloses that the extract of Giovanetto is relatively impure and requires additional processing that demonstrates the extraction “is not composition-preserving” (Applicant’s Remarks, p. 5, ¶1).
However, Applicant’s interpretation of the references is speculative and thus unpersuasive. The presence of impurities does not mean that the steviol glycoside profile would be altered between the leaves and the extracted material. All of the additional processing steps in Payzant et al. would be at a practitioner’s discretion, who would be motivated to maintain the integrity of the extracted material. If a process destroyed the target material, a practitioner would avoid performing such a process. Examiner maintains that the general extraction process taught in Giovanetto is adequate to deem the claimed general extraction process obvious.
Applicant next asserted that “[t]he cited art provides no evidence that any prior art plant inherently contains two elevated steviol glycosides” (Applicant’s Remarks, p. 5, ¶2).
Critically, though, the claims do not require elevated concentrations of steviol glycosides in either the starting material or the extract material. Claim 1 recites that the steviol glycosides are “at or above its common relative concentration”.
Applicant further argued that a skilled practitioner would not have reasonably expected that Giovanetto “would preserve or reveal the relative concentrations of individual minor steviol glycosides” (Applicant’s Remarks, p. 5, ¶3). Applicant alleged that Payzant was intended to improve on the method of Giovanetto and concluded that such improvements would not be “composition-preserving”. Id.
However, Giovanetto is presumed to be operable. MPEP 2121 I. The present claim rejection does not rely on combining the instruction of Payzant et al. with that of Giovanetto, since Payzant et al. is relied on only as an evidentiary reference for clarification regarding the interpretation of Giovanetto, such that any subsequent processing/purification steps disclosed in Payzant et al. would not be performed. Thus, the product obtained from Giovanetto, even at a purity of about 75% (C2, L52-L54), is presumed to produce a mixture of extracts that reflects the steviol glycoside profile in the starting leaf material.
Applicant then alleged that “[t]he amended claim requires the each of at least two minor glycosides exceed these baseline levels” (Applicant’s Remarks, p. 6, ¶2).
However, Applicant’s allegation contradicts claim 1, which only requires that the steviol glycosides are “at or above its common relative concentration”. The claim does not require any of the noted steviol glycosides to be above their common relative concentration. It merely requires that they are at the concentration at which they would naturally occur. It does not matter whether an extract obtained by Giovanetto was “dominated by major glycosides and impurities”; claim 1 merely requires the presence of two steviol glycosides at concentrations consistent with naturally-occurring concentrations. The presence or absence of any other components is of no consequence.
Applicant’s arguments are unpersuasive.
The rejections of claims 1-4 have been maintained herein.
Claim Rejections - 35 U.S.C. § 103 of claims 1-4 over Giovanetto, Brower et al., and Payzant et al.: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant first argued that “Brower does not disclose two elevated minor steviol glycosides” (Applicant’s Remarks, p. 6, ¶3).
As discussed above, claim 1 does not require elevated concentrations of any steviol glycosides, due to indicating that the steviol glycosides are “at or above its common relative concentration”. Regardless, Brower et al. further states: “It is noted that a high rebD plant may also be a high rebM and/or a high rebN plant.” (p. 2, ¶7). Applicant’s assertion to the contrary is thus incorrect.
Applicant asserted that a skilled practitioner would have no motivation to combine Giovanetto with Brower et al., since Payzant et al. allegedly disparages the method of Giovanetto, while Brower et al. is directed toward purified or enriched rebaudioside D compositions (Applicant’s Remarks, p. 6, ¶4 – p. 7, ¶1). Applicant also asserted that there would be no reasonable expectation of success in combining the references (Applicant’s Remarks, p. 7, ¶2 – p. 8, ¶1).
However, the combination of references relies only on incorporating leaves taught according to Brower et al. into an extraction process as taught in Giovanetto. Applicant’s arguments regarding alleged differences in purity of the obtained components or the complexity of the processes are unpersuasive due to mischaracterizing the nature of the combination of the references. Examiner further maintains that the simple incorporation of certain leaves into a conventional extraction method provides an adequate basis for reasonably expecting the extraction of target components.
Applicant next argued that “the inherency theory underlying both rejections is legally insufficient” (Applicant’s Remarks, p. 8, ¶2).
Again, claim 1 does not require “two elevated minor glycosides”, which undermines all of Applicant’s arguments based on a narrower version of the claim than what is actually written. Also, Brower et al. does state: “It is noted that a high rebD plant may also be a high rebM and/or a high rebN plant.” (p. 2, ¶7), which is an additional, independent reason for finding Applicant’s arguments unpersuasive.
The rejections of claims 1-4 have been maintained herein.
Double patenting: Applicant requested the double patenting rejections be held in abeyance (Applicant’s Remarks, p. 10, ¶1).
The double patenting rejections have been maintained herein.
Conclusion
Claims 1-4 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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