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 .
Restriction Requirement and Election of Species
Newly submitted claims 28-55 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
In the previous action the office required that the applicant elect one of nine inventions. Each of these inventions included the following claims:
A claim to a Stevia rebaudiana plant comprising a ratio of a class of steviol glycosides as compared to the total amount of steviol glycosides.
A claim to a method of preparing a novel extract from that plant and a consumable.
A claim to a consumable, food or beverage comprising one or more novel extracts produced from the claimed plant.
In response to that requirement, applicant elected claims drawn to SvGn family steviol glycosides. Applicant also canceled all of the previously presented claims and added 27 new claims. These new claims are drawn to the same inventions as those of the previously examined claims with a modification to change the dependence structure. Applicant presents the same groups of inventions drawn to a plant claim, a process claim and a consumable claim each comprising one of the nine groups of steviol glycosides the major change is that applicant has added a new independent claim which is drawn to a Stevia rebaudiana plant having steviol glycosides chosen from the nine steviol glycosides.
The result of this addition of a new more broad independent claim is that rather than presenting each of these inventions as a different group to which a restriction requirement is appropriate, applicant has now presented each group of steviol glycosides as a species.
Given this fact pattern, should it be the case that the different species are distinct and that there would be a search burden associated with examining all of the claimed species then an election of species requirement would be appropriate.
In the instant case this application now contains claims directed to the following patentably distinct species SvGn family steviol glycosides, SvRiGn family steviol glycosides, ScXlGn family steviol glycosides, RebM, RebO, RebD, RebN, RebE and RebM, RebO, RebD, RebN and RebE together. The species are independent or distinct because while these different compounds are all members of the steviol glycoside family they have distinct structures and functions by which they have been separated into each group in the art, see paragraph 0005 on page 2 of the instant specification for description on the structural differences of each of the claimed species. These species do not appear to be interchangeable and it does not currently appear that one species would anticipate or render obvious the other species. In addition, these species are not obvious variants of each other based on the current record.
As demonstrated by the analysis above, the newly presented species retain the distinctness presented in the analysis of the different groups in the previous restriction requirement. Similarly these species present a significant search burden due to their distinct structures and associated characteristics.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 28-31 are examined in this action and claims 32-55 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
To ensure compact prosecution, applicants arguments presented in the response to the restriction requirement mailed 12/05/2025 are addressed as follows. Applicant urges that the claimed Stevia rebaudiana plant and the steviol glycosides of that plant do not lack unity and that therefore the examination burden would not be undue. In response the office agrees that as written the claims have unity, however, the office disagrees with Applicant on the search burden of examining the currently filed claims. As presented above, applicant’s restructuring of the claims provides unity among the previously restricted groups but introduces several species and generic claims and along with the search burden associated with searching and analyzing the distinct structures represented by each of the claimed steviol glycosides a requirement to elect one species among these is appropriate.
Claim Status
Claims 28-55 are pending.
Applicants’ election with traverse of traverse of Group I, which aligns with new claims 28-31 in the reply filed on 02/05/2026 is acknowledged and treated as final, see Restriction Requirement and Election of Species section above.
Claims 32-55 are withdrawn from consideration for being drawn to non-elected inventions.
Claims 28-31 are examined on the merits.
Claim Objections
Claims 28 and 30 are objected to because of the following informalities: the claims recite “Stevia rebaudiana” and “stevia rebaudiana”. Traditionally, the convention with scientific names, including Stevia rebaudiana, is for the genus to be capitalized and the specific epithet to be lower case and the whole name to be italicized. Correction is requested. Alternatively the office suggests amending either “Stevia rebaudiana” or “stevia rebaudiana” to recite the other for consistency. Appropriate correction is requested.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 28-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The invention of claim 28 is directed to a drawn to a product of nature without significantly more. The claim recites “A Stevia rebaudiana plant, wherein the stevia rebaudiana plant comprises steviol glycosides chosen from SvGn family steviol glycosides”, the claim continues reciting unelected species of steviol glycosides. This judicial exception is not integrated into a practical application because it is simply drawn to a Stevia rebaudiana plant comprising SvGn family steviol glycosides. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not include any additional elements and Stevia rebaudiana plants comprising SvGn family steviol glycosides are naturally occurring. Evidence that the claimed plants are naturally occurring can be found in the instant specification in paragraphs 0005 and 0007 on page 2, as provided below.
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Further, Zhou teaches that steviol glycosides (SG) is a kind of natural sweetener that is abundant in S. rebaudiana and that researchers classified the currently identified SG molecules according to the types of glycoside residues, namely the glucosyl steviol family (SvGn) (Zhou, Page 5368, Column 2)( Zhou, Applied microbiology and biotechnology 105.13 (2021): 5367-5381.)
Given the disclosures in both the instant specification and Zhou it appears that the claim is simply drawn to naturally occurring Stevia rebaudiana plants without requiring any other limitations and as such is drawn to a product of nature.
Claim 29 is drawn to the plant of claim 28, wherein the percentage ratio of SvGn family steviol glycosides content to total steviol glycoside content is at least about 77%. Similar to the plant of claim 28, the plant of claim 29 is drawn to a natural phenomenon without significantly more.
This judicial exception is not integrated into a practical application because it is simply drawn to a Stevia rebaudiana plant comprising SvGn family steviol glycosides where SvGn family steviol glycosides make up at least 77% of Total Steviol Glycosides. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not include any additional elements and Stevia rebaudiana plants comprising this ratio of SvGn family steviol glycosides are naturally occurring. Evidence that the claimed plants are naturally occurring can be found in Leszczyńska which describes steviol glycoside content in Stevia rebaudiana Bertoni dried leaves (Leszczyńska, Applied Sciences 11.8 (2021): 3634.).
Specifically, Leszczyńska in Table 2 on page 8 describes steviol glycoside content in populations grown in three different locations. Individual chemicals analyzed include Rubusoside, Steviolbioside, Dulcoside A, Rebaudioside B, Stevioside, Rebaudioside C, Rebaudioside F, Rebaudioside A, Rebaudioside E, Rebaudioside D and the sum of all steviol glycosides is also reported. In each population the percentage of steviol glycosides which make up the SvGn family (as described in table 3 on page 90 of the instant specification) compared to the sum total of the steviol glycosides is greater than 95%. While Leszczyńska does not report all of the individual chemicals described in table 3 of the instant specification, Leszczyńska does provide a sum total value of steviol glycosides and provides values for all but one of the SvGns described in table 3 of the instant specification. Adding this chemical to the analysis would only increase the percentage of the sum total of steviol glycosides that is made up by the SvGn steviol glycosides. Therefore, not only do Stevia rebaudiana plants comprising a ratio of SvGn steviol glycosides to total steviol glycosides that is equal to or greater than about 77% occur naturally, plants with ratios of greater than 95% appear to occur naturally.
Given that claim 29 does not provide any additional limitations, the claimed Stevia rebaudiana plant is naturally occurring and therefore claim 29 is rejected as being drawn to a judicial exception without substantially more.
The invention of claim 30 is directed to a drawn to a product of nature without significantly more, specifically a natural process. The claim recites a method for preparing one or more novel extracts from the Stevia rebaudiana plant of claim 29 comprising the following steps:
Providing plant biomass of the plant of claim 29 comprising at least one steviol glycoside.
Providing a solvent and contacting the Stevia rebaudiana biomass with solvent to extract at least one steviol glycoside.
Separating the Stevia rebaudiana plant biomass to obtain one or more novel extracts comprising the at least one steviol glycoside.
This judicial exception is not integrated into a practical application because it is drawn to a simple natural process and does not require any limitations or steps that require the intervention of man. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not include any elements beyond those summarized in the three steps above and this method has a naturally occurring counterpart.
The following natural process is found within the metes and bounds of the claimed method. The process comprising the following three occurrences.
The naturally occurring Stevia rebaudiana plant of claim 29 (See above for analysis with respect to claim 29) is growing in sandy soil in its natural environment in Paraguay.
Underneath the small canopy of the plant there is a pool of water. A damaged leaf with cellular contents exposed to the air falls from the plant into the pool and is contacted by the water. Contents of the leaf are contacted by the water to produce a solution of water with at least one steviol glycoside.
Wind picks up and the leaf is blown out of the pool leaving behind a novel extract comprising at least one steviol glycoside.
This product of nature would occur freely and without the intervention of man and meets all of the required steps of the claimed method and as such claim 30 is rejected as being drawn to one of the judicial exceptions without substantially more.
The invention of claim 31 is directed to a drawn to a product of nature without significantly more. The claim recites a consumable, food or beverage comprising one or more novel extracts produced by the process of claim 30. This judicial exception is not integrated into a practical application because it is drawn to a simple product of nature and does not require any limitations or steps that require the intervention of man.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not include any elements other than the extract produced by the naturally occurring method of claim 30 (See above for analysis with respect to claim 30). To reiterate the method of claim 30 has a naturally occurring counterpart which occurs when a damaged leaf from a Stevia rebaudiana plant falls into a pool of water and chemicals produced in the leaf leach into the water producing an extract.
Claim 31 is drawn to a consumable, food or beverage comprising this extract. Water comprising this leaf extract can be drank (consumed) and is therefore a consumable and a beverage and as such is a product of nature. The claim does not require any additional elements and is therefore rejected as drawn to a judicial exception without substantially more.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 29-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. The rejection includes dependent claims.
Regarding claim 29, the claim is drawn to a plant having a percentage ratio of SvGn family steviol glycosides to total steviol glycosides of at least about 77%. This is indefinite because it is unclear whether the claim is drawn to plants wherein a total plant extract shows the specifically claimed ratio or whether instead the claim is drawn to plants wherein this ratio is found in a single organ like leaves or in other similar structures.
To illustrate Bondarev describes differing concentrations of steviol glycosides in the different organs of Stevia rebaudiana plants (Bondarev, Page 261, Abstract; Bondarev, Page 262, Figure 1)(Bondarev, Biologia plantarum 47.2 (2003): 261-264.). It follows that in addition to the differing levels of total steviol glycosides in each organ there would be differing levels of each individual steviol glycosides between organs which would produce different SvGn/TSG percentage ratios between organs. In turn this could mean that a plant could have an organ which comprised the claimed SvGn/TSG ratio but when the whole plant was assessed together would not possess the required ratio.
As such there appears to be at least two distinct scopes of the claim and therefore the claim is rejected as indefinite. Claims 30-31 are rejected for depending on an indefinite claim and failing to limit the scope of the claim to definite subject matter.
The recitation of the term “novel extracts” in the first and seventh lines of claim 30 and in the first line of claim 31 render those claims indefinite. The scope imparted on the claim by novel extracts is unclear and the specification and state of the art fail to provide a limiting definition such that the scope of the claim is clear. While the specification states that “the dried leaves of at least one Stevia rebaudiana novel cultivar plant are subjected to extraction to obtain steviol glycosides compositions referred to hereinafter as “novel extract(s)” in paragraph 0092, the claims are not limited to “Stevia rebaudiana novel cultivar plants” and therefore it is not clear what characteristics are required of an extract to be novel. Additionally the specification does not describe “Stevia rebaudiana novel cultivar plants” such that the scope of this term is clear because the specification provides only examples of potential embodiments of novel cultivars without clarifying the requisite structures such that the metes and bounds of this term is clear.
As written it is unclear what “novel extract” indicates in the claim. It appears that this could indicate at least the following three things:
That this extract is distinct from any other extract of Stevia rebaudiana because it comes from a novel Stevia rebaudiana cultivar plant. This is supported by paragraph 0092 of the specification.
The process used to extract the chemicals from the Stevia rebaudiana plant was different.
The specific concentration of each steviol glycoside and any other chemical extracted differs in quantity as compared to other extracts. This appears to be the plain meaning of the term in the art.
This leads to questions about how much difference is required between the concentrations of each extracted chemical for an extract to be novel as compared to another extract.
Leszczyńska describes steviol glycoside profiles from the same cultivar of Stevia rebaudiana grown in three different locations (Leszczyńska, Page 8, Table 2). The samples from each location showed significant differences in the concentrations of individual and total steviol glycoside content (Leszczyńska, Page 8, Table 2). In this example would the extracts from the same cultivar grown in different locations be considered novel as compared to each other? Given that the answer to this question is unclear and similarly that the specific properties or structures that are required for an extract are not clear, the term “novel extracts” renders the claims indefinite and they are rejected. In order to ensure compact prosecution the term “novel extracts” is being interpreted to refer to any extract from the claimed plant.
The recitation of “separating the Stevia rebaudiana” plant biomass to obtain one or more novel extracts in the penultimate line of claim 30 renders the claim indefinite. The use of this term introduces at least three distinct scopes of the claims. In a first scope “separating the Stevia rebaudiana plant biomass” means removing the plant biomass from the solvent in order to obtain an extract not comprising the biomass. In a second scope, “separating the Stevia rebaudiana plant biomass” means dissecting the plant biomass into smaller pieces to obtain novel extracts. While in a third scope “separating the Stevia rebaudiana plant biomass” means separating the biomass and solvent into distinct solutions which are one or more novel extracts. Given that the use of this term has produced these differing scopes of the invention the metes and bounds of the claim are not clear and claim 30 is rejected as indefinite. Claim 31 is rejected for depending on an indefinite claim and failing to limit the scope of the claim to definite subject matter. In order to ensure compact prosecution the phrase “separating the Stevia rebaudiana” plant biomass is interpreted to mean removing the biomass from the solution comprising the at least one steviol glycoside and the solvent.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 28-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ceunen, Plant Science 198 (2013): 72-82 as evidenced by Leszczyńska, Applied Sciences 11.8 (2021): 3634.
The claims are drawn to Stevia rebaudiana plants, processes for preparing novel extracts from these plants and a consumable, food or beverage comprising these novel extracts. Importantly the plant claims (Claims 28-29) are limited to Stevia rebaudiana plants comprising SvGn family steviol glycosides (Claim 28) and those plants which comprise a percentage ratio of SvGn family steviol glycosides to total steviol glycosides of greater than about 77% (Claim 29).
In order to promote clarity, the examiner is interpreting SvGn family steviol glycosides which are also referred to as glucosyl family glycosides, see Zhou, to refer to Rubusoside (Rub), Steviolbioside (Sbio), Stevioside (Stev), Rebaudioside A (RebA), Rebaudioside B (RebB), Rebaudioside D (RebD), Rebaudioside E (RebE) and Rebaudioside M (RebM). This interpretation is consistent with applicant’s description provided in Table 3 on page 90 of the specification.
With respect to claim 28, Ceunen discloses a stevia rebaudiana plant and plant parts from that plant (Ceunen, Page 72, Abstract; Ceunen, Page 73, Column 1, Third Paragraph), wherein the plants comprise the SvGn steviol glycosides, stevioside (ST), rebaudioside A (Reb A), reabudiosides B (Reb B), rubusoside (Rub) and steviolbioside (SB) (Ceunen, Page 73, Column 2, Paragraph 6).
With respect to claim 29, Ceunen discloses all of the limitations of claim 28, see above. Further, while Ceunen does not explicitly state that the plant comprises a percentage ratio of SvGn family steviol glycosides to total steviolglycoside of at least about 77% nor does Ceunen disclose concentrations of all of the SvGns listed in table 3 of the instant specification, this appears to be an intrinsic property of Stevia rebaudiana plants as demonstrated by Leszczyńska.
Specifically, Leszczyńska in Table 2 on page 8, describes steviol glycoside content in populations grown in three different locations. Individual chemicals analyzed include Rubusoside, Steviolbioside, Dulcoside A, Rebaudioside B, Stevioside, Rebaudioside C, Rebaudioside F, Rebaudioside A, Rebaudioside E, Rebaudioside D and the sum of all steviol glycosides is also reported. In each population, the percentage of steviol glycosides which make up the SvGn family as compared to the sum total of the steviol glycosides is greater than 95%. While Leszczyńska does not report all of the individual chemicals described in table 3 of the instant specification, Leszczyńska does provide a sum total value of steviol glycosides and provides values for all but one of the SvGns described in table 3 of the instant specification. Adding this chemical to the analysis would only increase the percentage of the sum total of steviol glycosides that is made up by the SvGn steviol glycosides.
Therefore, a percentage ratio of SvGn family steviol glycosides content to TSG content of at least about 77% appears to be an inherent property of Stevia rebaudiana plants.
With respect to claim 30, Ceunen discloses all of the limitations of claim 29, see above. Further, Ceunen discloses methods of extracting novel steviol glycoside solutions comprising contacting dried and pulverized plant material with HPLC-grade water, a solvent. A fourth extraction was considered but given the yield was very low three extractions were performed after which the solutions comprising the steviol glycosides were pooled. This demonstrates that at this step the pooled steviol extracts were separated from the plant biomass which did not undergo any further extractions. HPLC was performed which showed that the extracts comprised several members of the SvGn family of steviol glycosides including stevioside (ST), rebaudioside A (Reb A), reabudiosides B (Reb B), rubusoside (Rub) and steviolbioside (SB) (Ceunen, Page 73, Column 2, Paragraph 6).
With respect to claim 31, Ceunen discloses all of the limitations of claim 30, see above. Further, given that Ceunen discloses steviol glycosides in water, Cuenen discloses a consumable beverage comprising the novel extracts (Ceunen, Page 73, Column 2, Paragraph 6).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US Patent US 11,723,387 B2 which is the parent of the instant application as evidenced by Zhou, Applied microbiology and biotechnology 105.13 (2021): 5367-5381.
For clarity the following aspects of the fact pattern of the instant application are presented below:
The instant application is a Divisional application of 15/822,137 which was patented and issued as US 11,723,387 B2 on August 15, 2023, the day after the instant application was filed and is referred to hereafter as ‘387.
The MPEP in section 804.01 makes clear that 35 U.S.C. 121 prohibits the use of a patent in which a restriction requirement was made as a reference against any divisional application in a nonstatutory double patenting rejection if the divisional application is filed before the issuance of the patent (MPEP Section 804.01, Second Sentence of the First Paragraph).
While the fact pattern of the instant application fits the above scenario in which 35 U.S.C 121 prohibits nonstatutory double patenting in the instant case this rejection remains appropriate and is presented below. The rejection remains appropriate because while 35 U.S.C. 121 does generally prohibit nonstatutory double patenting rejections in applications having similar fact patterns to the instant application there are several situations in which this prohibition does not apply. These eight exceptions are provided in the MPEP in section 804.01.
In the instant case the exception summarized in (B) of the MPEP applies. The exception states that in cases where “The claims of the application under examination and claims of the other application/patent are not consonant with the restriction requirement made by the examiner, since the claims have been changed in material aspects from the claims at the time the requirement was made.” “In order for consonance to exist, the line of demarcation between the independent and distinct inventions identified by the examiner in the requirement for restriction must be maintained”.
During the prosecution of the application which resulted in the ‘387 patent there was a restriction requirement and then a later election of species requirement. It is the restriction requirement dated 09/24/2019 which split the claims into separate groups including one which is similar to the instantly examined claims. In this restriction the office required that Applicant elect one of 13 inventions drawn to different groups of claims.
Invention III was drawn to claims 9-11 of the 11/25/2017 claims. These claims are drawn to “A Stevia rebaudiana plant, wherein the percentage ratio of SvGn family steviol glycosides content to TSG (Total Steviol Glycoside) content is at least about 77%” (Claim 9) as well as processes for preparing novel extracts from the plant of claim 9 (Claim 10) and a consumable, food, or beverage comprising one or more novel extracts produced by the process of claim 10 (Claim 11).
In comparing these claims to claims of the instant application it is clear that instant claims 29-31 of the claimset dated 02/05/2026 share scope with claims 9-11 of the reference patent and therefore nonstatutory double patenting is not appropriate against those claims.
However, instant claim 28 of the claimset dated 02/05/2026 has a much more broad scope and the invention of this claim is not consonant with invention III of the 2019 restriction requirement. This is because while the restricted claims of the reference require a specific ratio of SvGn steviol glycosides to total steviol glycosides, instant claim 28 only requires that the plants comprise at least one steviol glycoside of the SvGn family.
As such claim 28 is not consonant with the claims of invention III of the 2019 restriction requirement and nonstatutory double patenting against this claim is appropriate.
In analyzing the scope of the claim 28, particularly in light of the instant specification and Zhou, it is clear that comprising SvGn steviol glycosides is an inherent characteristic of Stevia rebaudiana plants. Therefore the broadest reasonable scope of claim 28 is drawn to any Stevia rebaudiana plant whatsoever. Claim 1 of the reference patent ‘387 is drawn to “A self-compatible Stevia rebaudiana plant wherein the self-compatibility results in a self-fertilization rate greater than 0.1%, and wherein a representative sample of a self-compatible Stevia rebaudiana plant was deposited under CGMCC Accession No. 11712”. The claim is drawn to a Stevia rebaudiana plant and the analysis in the 35 USC 101 rejection above makes clear that possessing SvGn steviol glycosides is an inherent characteristic of Stevia rebaudiana plants.
As such, claim 1 of ‘387 anticipates claim 28 and it is therefore rejected on the grounds of nonstatutory double patenting.
Claims 28-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 24-25 of Markosyan, US Patent US 12,284,959 B2 which shares inventors and an applicant with the instant application.
With respect to claim 28, although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the instant invention is drawn to a Stevia rebaudiana plant comprising steviol glycosides chosen from the SvGn family which table 3 in the instant specification makes clear include Rubusoside (Rub), Steviolbioside (Sbio), Stevioside (Stev), Rebaudioside A (Reb A), Rebaudioside B (Reb B), Rebaudioside D (Reb D), Rebaudioside E (Reb E) and Rebaudioside M (Reb M). While, claim 1 of the reference is drawn to a propagated plant of stevia cultivar ‘320032’ which as an inherent property comprises the SvGn family glycosides Reb E, Reb D, Reb M, Reb A and Stev (‘959, Column 31, Claim 1; ‘959, Column 8, Table 3). Therefore it is clear that claim 1 of the reference is drawn to a Stevia rebaudiana plant comprising SvGn family steviol glycosides and therefore claim 28 is rejected on the grounds of non-statutory double patenting over Markosyan ‘959.
With respect to claim 29, although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim is drawn to a Stevia rebaudiana plant comprising a percentage ratio of SvGn family glycosides to total steviol glycosides of about at least 77%. While, claim 1 of the reference is drawn to a propagated plant of stevia cultivar ‘320032’ which as an inherent property comprises the SvGn family glycosides Reb E, Reb D, Reb M, Reb A and Stev (‘959, Column 31, Claim 1; ‘959, Column 8, Table 3).
Further, table 3 of ‘959 shows that the Reb A content of stevia ‘320032’ is 15.79% while the total steviol glycosides content is 20.53%. Using these values to determine the percentage ratio of Reb A to total steviol glycosides produces a ratio of 76.91 or about 77% and this value was produced using only Reb A. When the other SvGn family glycosides are considered the ratio is greater than 77%. Therefore, although the claims at issue are not identical it is clear that plant of claim 1 of the reference anticipates instant claim 29 and therefore claim 29 is rejected on the grounds of non-statutory double patenting over Markosyan ‘959.
With respect to claim 30, although the claims at issue are not identical, they are not patentably distinct from each other. The claim of the instant invention is drawn to a process of preparing novel extracts from the Stevia rebaudiana plant of claim 29 comprising the following steps:
providing a plant biomass of the Stevia rebaudiana plant of claim 29 comprising at least one steviol glycoside and providing solvent.
Contacting the Stevia rebaudiana plant biomass with solvent to extract at least one steviol glycoside from the plant biomass;
Separating the Stevia rebaudiana plant biomass to obtain one or more novel extracts comprising at least one steviol glycoside.
Claim 24 of the ‘959 reference is drawn to a method for producing a sweetener composition containing steviol glycosides by extracting dried leaves of a Stevia variety ‘320032’ plant, which as noted above anticipates all of the limitations of instant claim 29. This method comprises the following steps:
providing dried leaves (plant biomass) of a Stevia variety ‘320032’ plant (plant which anticipates the plant of instant claim 29) and water or an aqueous solvent (solvent) (‘959, Column 31, Claim 1).
Extracting dried leaves of the plant with the solvent, which lines 2-8 of column 8 of ‘959 states comprises drying leaf samples and grinding them into fine powder to which distilled water was added for 18 hours to extract the steviol glycosides (‘959, Column 8, Lines 2-6).
After extraction, the mixture was centrifuged and the supernatant was filtered and used for further analysis, while the plant biomass in the pellet was left behind (‘959, Column 31, Claim 1; ‘959, Column 8, Lines 2-10). In this step the plant biomass was separated in order to produce novel steviol extracts.
Therefore, although the claims at issue are not identical it is clear that the method of claim 24 of ‘959 anticipates instant claim 30 and therefore claim 30 is rejected on the grounds of non-statutory double patenting over Markosyan ‘959.
With respect to claim 31, although the claims at issue are not identical, they are not patentably distinct from each other. The claim of the instant invention is drawn to a consumable, food or beverage comprising one or more novel extracts produced by the process of claim 30, while claim 25 of the ‘959 reference is drawn to A sweetener composition produced using the method of claim 24 of ‘959.
Given the analysis above, which demonstrates that claim 24 of ‘959 anticipates instant claim 30 and that claim 25 of the reference teaches a sweetener (a consumable) produced using this method, claim 25 of the reference anticipates instant claim 31 and therefore claim 31 is rejected on the grounds of non-statutory double patenting over claim 25 of ‘959.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached 7:30 to 5:00.
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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663