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 .
Election/Restriction
Applicant’s election, without traverse, of Group III (claims 6-7 and 10-11), genetic feature 3 (SEQ ID NO: 3), and chemical feature (a) in the reply filed on 06/26/2026 is acknowledged.
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior
to declaration of an interference, a certified English translation of the foreign application must be
submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-
English application.
Status of the Claims
Claims 1-7 and 10-19 are pending.
Claims 1-5 and 12-19 have been withdrawn.
Claims 6-7 and 10-11 are examined in this Office action.
Information Disclosure Statement
Initialed and dated copy of Applicant’s Information Disclosure Statements (IDS) filed on 02/18/2025 and 04/15/2026 are attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Claim Interpretation
The recitation in claim 1 of “(a) a content ratio of rebaudioside M (RebM) to rebaudioside D (RebD) is high as compared with a stevia plant that does not have any of the genetic features (1) to (3)” will be interpreted as: a decimal representation of the ratio of RebM to RebD that is closer to 1.0 is higher than a decimal representation of the ratio of RebM to RebD that is closer to 0.0. For example, a stevia plant with a content of 0.554986% RebM and 0.800119% RebD has a higher content ratio (0.694) than a stevia plant with a content of 0.130488% RebM and 0.913192% RebD (0.143).
Claim Rejections - 35 USC § 112(b)
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.
Indefiniteness
Claims 6-7 and 10-11 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
Claim 7 recites “wherein the plant has at least one of the chemical features (a) to (r)”. Chemical feature (a) (Applicant’s species election) is defined in claim 1 as: (a) a content ratio of rebaudioside M (RebM) to rebaudioside D (RebD) is high as compared with a stevia plant that does not have any of the genetic features (1) to (3).
The term “high” in claim 1 is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Is “high” considered a 10% increase? Double? 10X?
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 6-7 and 10-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are broadly drawn to a stevia plant having at least one of the genetic features (1) to (3). The phrase “at least one of the genetic features (1) to (3)” encompasses the possibility of only one of the genetic features (1) to (3) being indicative of the recited chemical features. Applicant has elected genetic feature (3), which is defined in claim 1 as (3) heterozygous or homozygous for an allele wherein the base at the position corresponding to position 170 of SEQ ID NO: 3 is C. Applicant has elected chemical feature (a), which is defined in claim 1 as (a) a content ratio of RebM to RebD is high as compared with a stevia plant that does not have any of the genetic features (1) to (3).
Applicant describes that commercially available stevia plants were selected and crossed over three generations by focusing on the content of RebD or RebM to obtain population A with high RebD content and population B with high RebM content. Further, the populations A and B were crossed to obtain segregating population C (instant Specification, page 56, paragraph 0154).
Applicant further describes that an appropriate amount of fresh leaves was sampled from each grown individual in the population C, and the concentration of RebA, RebB, RebC, RebD, RebE, RebF, RebG, RebM, RebN and stevioside was quantitatively determined (instant Specification, page 56, paragraph 0155).
Applicant describes the identification of a correlation between the presence of genetic features (1) to (3) and a tendency in which the content ratio of RebM to RebD in individual groups having the genetic features was higher than that in individuals that did not have the genetic features (instant Specification, page 62, paragraph 0157; Tables 2 and 3, pages 57-62). However, the results described in Tables 2-7 demonstrate that individual genetic features are unlikely to be predictive of a high ratio of RebM to RebD. For example, stevia plant C5, which is the only stevia plant to comprise only elected genetic feature (3), has a ratio of RebM to RebD of 0.167; stevia plants C35 and C51, which comprise only genetic feature (1), have a ratio of RebM to RebD of 0.0.545 and 0.534, respectively; and stevia plants C36, C42, and C63, which comprise only genetic feature (2), have a ratio of RebM to RebD of 0.261, 0.185, and 0.424, respectively. Based on the information provided in Tables 2 and 3, the identification of individual genetic features is inconsistent for the ratio of RebM to RebD, and is unlikely predictive of a high ratio of RebM to RebD in stevia plants.
Additionally, the claims require the ratio of RebM to RebD to be high as compared with a stevia plant that does not have any of the genetic features (1) to (3). The information provided in Tables 2 and 3 shows a wide range of values for the ratio of RebM to RebD in stevia plants that do not have any of the genetic features (1) to (3), from a low of 0.143 (stevia plant C37) to a high of 0.694 (stevia plant C27). Thus, the identification of individual genetic features is unlikely predictive of a high ratio of RebM to RebD in stevia plants when compared with a stevia plant that does not have any of the genetic features.
In regard to table 8 (instant Specification, page 67), Applicant has presented the relationship between the genetic features, individually and in combination with one another, and the steviol glycoside content. The table shows that having only genetic feature (3), the content of RebD was smaller than that in individual groups of the other individuals, and the content of RebM was larger than that in individual groups of the other individuals. However, it is noted that the population of stevia plants tested that comprised only genetic feature (3) is one stevia plant (C5).
Given that there have not been an adequate number of species reduced to practice to be representative of only one of the genetic features (1) to (3) being indicative of the recited chemical features, there is not adequate description to support the breadth of the claims.
Claim 6 is specifically rejected under 35 USC 112(a) Written Description because the claim does not require the progeny plant thereof to retain the genetic features or the phenotype as recited in claim 1. Additionally, the claim puts no limitation on the number of generations the progeny plant can be from the instantly claimed stevia plant. Because the progeny plant reads on an unlimited number of generations with no limitations on the retained genetic features or phenotypes, the claimed genus lacks written description of (1) a representative number of species and (2) no described structure function in common with the genus.
Claim 11 is specifically rejected under 35 USC 112(a) Written Description because the claim does not require the tissue, tissue culture, or cell (embryo) to retain the genetic features or the phenotype as of the instant stevia plant. Because the tissue, tissue culture, or cell (embryo) reads on an F2 generation with no limitations on the retained genetic features or phenotypes, the claimed genus lacks written description of (1) a representative number of species and (2) no described structure function in common with the genus.
Claim Rejections - 35 USC § 102/103
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 (i.e., changing from AIA to pre-AIA ) 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 6-7 and 10-11 are rejected under 35 U.S.C. 102(a) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over MARKOSYAN (Markosyan et al., WO 2016/049531 A1; 31 March 2016; included on IDS dated 02/18/2025).
EXAMINER’S COMMENT: This rejection is conditional upon the response to the 37 CFR § 1.105 request (see attachment to the Office action) asking for the commercial sources that were used to develop the instant stevia plants of the invention. Applicant has not provided the genetic source of the instant stevia plant; therefore, it is impossible to know whether the commercially available stevia plants used to produce the instantly claimed stevia plants inherently comprise the genetic features (1) to (3) as recited in claim 1. Applicant is not suggesting that the instantly claimed stevia plants are unique, since they were bred from commercially available lines.
Claim 6 recites “a stevia plant having at least one of the genetic features (1) to (3) defined in claim 1, wherein the plant includes a stevia plant subjected to a mutagenesis treatment and a progeny plant thereof”.
MARKOSYAN teaches eight markers (the SNPs identified in SEQ ID NOs: 1-8) for the identification of stevia varieties with high RebD content, high RebM content or varieties with both RebD and RebM content (Markosyan, page 15, paragraph 00190). MARKOSYAN teaches stevia plants “814011” and “807086” which contain a high content ratio of RebM to RebD (1.009 and 0.645, respectively) (Markosyan, Table 6, page 32).
Although MARKOSYAN does not explicitly teach stevia plants with genetic features (1) to (3), the instant stevia plants with genetic features (1) to (3) and stevia plants “814011” and “807086” as taught by MARKOSYAN contain a high content ratio of RebM to RebD.
MARKOSYAN teaches that mutation breeding is another method of introducing new traits into stevia varieties. Mutations that occur spontaneously or are artificially induced can be useful sources of variability for a plant breeder. The goal of artificial mutagenesis is to increase the rate of mutation for a desired characteristic. Once a desired trait is observed through mutagenesis the trait may then be incorporated into existing germplasm by traditional breeding techniques (i.e., the plant includes a stevia plant subjected to a mutagenesis treatment) (Markosyan, page 48, paragraph 00288).
MARKOSYAN teaches methods for introgressing the disclosed SNPs associated with high RebD and high RebM into stevia plants by selecting plants comprising for one or more SNPs and breeding with such plants to confer such desirable agronomic phenotypes to plant progeny (i.e., a progeny plant thereof) (Markosyan, Abstract).
In regard to claim 7, MARKOSYAN teaches stevia plants “814011” and “807086” which contain a high content ratio of RebM to RebD (1.009 and 0.645, respectively) (i.e., wherein the plant has the chemical feature (a)) (Markosyan, Table 6, page 32).
In regard to claims 10 and 11, MARKOSYAN teaches that further reproduction of the variety can occur by tissue culture and regeneration. Tissue culture of various tissues of stevia and regeneration of plants therefrom is well known and widely published (i.e., a seed, a tissue, a dried leaf, a tissue culture or a cell of the plant (instant claim 10)) (Markosyan, page 63, paragraph 00351).
MARKOSYAN further teaches types of tissue cultures are protoplasts, calli, plant clumps, and plant cells that can generate tissue culture that are intact in plants or parts of plants, such as embryos, pollen, flowers, seeds, leaves, stems, roots, root tips, anthers, pistils, and the like (i.e., the tissue, tissue culture or cell selected from the group consisting of an embryo, a meristem cell, a pollen, a leaf, a root, a root apex, a petal, a protoplast, a leaf section and a callus (instant claim 11)) (Markosyan, page 63, paragraph 00352).
Summary
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MEADOWS whose telephone number is (703)756-1430. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached at 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTINA L MEADOWS/Examiner, Art Unit 1663
CHRISTINA MEADOWS
Examiner
Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
ATTACHMENT TO OFFICE ACTION
Request for Information under 37 CFR § 1.105
1. Applicants and the assignee of this application are required under 37 CFR § 1.105 to provide the following information that the Examiner has determined is reasonably necessary to the examination of this application.
2. This request is being made for the following reasons:
Applicants are claiming a stevia plant, but the instant specification inadequately describes what starting materials and methods were used to produce the claimed (stevia) plant. The requested information is required to make a meaningful and complete search of the prior art.
3. In response to this requirement, if known, please provide answers to each of the following interrogatories eliciting factual information:
Please supply the breeding methodology and history regarding the development of the instant plant.
a) Such information should include all of the public or commercial designations/denominations used for the original parental lines;
b) Information pertaining to the public availability of the original parental lines should be set forth;
c) The breeding method used should be set forth, such as whether single seed descent, bulk method, backcross method, or some other method was used;
d) The filial generation in which the instant plant was chosen should be set forth;
e) Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth;
f) Are there any patent applications or patents in which sibs or parents of the instant plant are claimed? If so, please set forth serial numbers and names of the sibs or parents;
g) Information available regarding the first sale or other public distribution of the claimed plant variety anywhere in the world, including date(s) and location of any sale or other public distribution including any public information available regarding sales, offers for sale, or public distributions of the claimed plant variety that occurred before the effective filing date of the claimed invention, including information pertaining to whether this was an obscure, solitary occurrence that would go unnoticed by those skilled in the art;
h) A copy of any plant breeder's rights applications, published proposed denominations, and breeder's rights grants, relating to the claimed plant variety, before the effective filing date of this instant application;
i) A copy of any publications or advertisements relating to sales, offers for sale, or public distributions of the claimed plant variety anywhere in the world if the sale, offer for sale, or public distribution occurred before the effective filing date of this instant application;
j) Any information relating to the accessibility or non-accessibility of the claimed plant variety that one of ordinary skill in the art could have derived from the printed plant breeder’s right document;
k) Inventor is also invited to submit any information that would indicate that one of ordinary skill in the art would not have known how to successfully reproduce the claimed plant variety; and
l) A listing of every trade name, trademark, proposed denomination, published denomination or testing designation used to refer to, designate or market the claimed plant anywhere in the world.
The Office does not maintain a collection of Plant Breeders’ Rights documents and they are not readily obtainable electronically. It is reasonable to expect that Inventor or Applicants (assignee) can readily obtain the requested documents and information.
4. If Applicants view any or all of the above requested information as a Trade Secret, then Applicants should follow the guidance of MPEP § 724.02 when submitting the requested information.
5. In responding to those requirements that require copies of documents, where the document is a bound text or a single article over 50 pages, the requirement may be met by providing copies of those pages that provide the particular subject matter indicated in the requirement, or where such subject matter is not indicated, the subject matter found in applicant’s disclosure. Please indicate where the relevant information can be found.
6. The fee and certification requirements of 37 CFR § 1.97 are waived for those documents submitted in reply to this requirement. This waiver extends only to those documents within the scope of this requirement under 37 CFR § 1.105 that are included in the applicant’s first complete communication responding to this requirement. Any supplemental replies subsequent to the first communication responding to this requirement and any information disclosures beyond the scope of this requirement under 37 CFR § 1.105 are subject to the fee and certification requirements of 37 CFR § 1.97 if submitted subsequent to a first Office action on the merits.
7. The Applicants are reminded that the reply to this requirement must be made with candor and good faith under 37 CFR § 1.56. Where the Applicants do not have or cannot readily obtain an item of required information, a statement that the item is unknown or cannot be readily obtained may be accepted as a complete reply to the requirement for that item.
8. This requirement is an attachment of the enclosed Office action. A complete reply to the enclosed Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the enclosed Office action.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MEADOWS whose telephone number is (703) 756-1430. The examiner can normally be reached on Monday - Friday, 08:00 - 17:00 h EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, AMJAD A. ABRAHAM, can be reached on (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/Amjad Abraham/SPE, Art Unit 1663
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