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/Restrictions
Applicant’s election without traverse of Group I, claims 1-11 in the reply filed on 25 March 2026 is acknowledged.
Claims 12-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 25 March 2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Specification
The Specification is objected to because it lacks a cross-reference to related applications, see 37 CFR 1.78.
The Specification is objected to because the acronym “FRO2”, at page 2 line 11 for example, is not defined.
Claim Interpretation
The claims are directed to a stevia plant having a polymorphism at the position corresponding to position 37 of SEQ ID NO: 1. Said polymorphism appears to be at the codon for the Phe57 position of the Stevia rebaudiana FRO2 shown in instant SEQ ID NO: 14. The codons TTT and TTC both encode phenylalanine hence the polymorphism does not change the expressed polypeptide. The term FRO2 appears to be to a ferric chelate reductase.
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 1-11 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.
Claim 1 is indefinite because SEQ ID NO: 1 is 70bp long and the claim is only directed to a relative position but does not state what gene the genotype C/C occurs. Further, the genus Stevia contains about 240 species. Hence, it is unclear what the metes and bounds of the claim are. Claims 2-11 are also indefinite because they do not obviate the indefiniteness of claim 1 upon which they depend.
Claims 2 and 6 are indefinite because neither the claims nor the specification defines “FRO2”, said “FRO2” is arbitrary. Hence, the metes and bounds of the claims are unclear.
Claim 5 is indefinite because it is directed to a product-by-process, and it is unclear if the tissue culture, in particular produced from an embryo, has the genotype C/C as recited in claim 1 upon which it depends. Hence, the metes and bounds of the claim are unclear.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the genotype of the second stevia plant. The second stevia plant would at least have to have a C/T genotype where 50% of the progeny would have the C/C genotype in order to have the “at least one component” recited in the claim.
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.
Claims 1-11 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.
Applicant claims a stevia plant having the genotype C/C at a position corresponding to position 37 of SEQ ID NO: 1, and a method comprising crossing said stevia plant with a second stevia plant.
Applicant describes a Stevia rebaudiana that comprises a T-C polymorphism at the third position of the 57th codon (for phenylalanine) of a FRO2 coding sequence and that when the Stevia rebaudiana is homozygous C/C at said third position the Stevia rebaudiana exhibits increased, on average, rebaudioside D and rebaudioside M content as shown in Figure 2.
Applicant does not describe stevia plants with the genotype C/C at a position corresponding to position 37 of SEQ ID NO: 1 in genes other than the FRO2 coding sequence or in stevia plants other than Stevia rebaudiana. Applicant does not describe a nexus between FRO2 expression levels and RebD and RebM levels. Figure 6 does not appear to support Applicant’s assertion of a relationship between the level of FRO2 expression and RebD and RebM levels. The recited polymorphism in the FRO2 gene is conservative and does not change the structure of the FRO2 gene product. Applicant appears to be claiming the invention, “an FRO2 expression level lower than in the control stevia plant”, merely by function without any correlating structure.
Hence, it is unclear that Applicant was in possession of the invention as broadly claimed.
See Amgen inc. v Chagai Pharmaceutical co., 18 USPQ 2d 1016 (Fed. Cir. 1991), which teaches that the conception of a chemical compound requires the inventor to be able to define the compound so as to distinguish it from other materials, and to describe how to obtain it rather than simply defining it solely by its principle biological property; thus, when an inventor of a gene, which is a chemical compound albeit a complex one, is unable to envision detailed constitution of the gene so as to distinguish it from other materials, as well as a method of obtaining it, the conception is not achieved until a reduction to practice has occurred, and until after the gene has been isolated.
The art teaches that plants can have a number of FRO (ferric chelate reductase) genes. In fact, Arabidopsis thaliana is known to have eight FRO genes (Jeong et al 2009, see Table 2 on page 711). Hence, it is unclear that Applicant had adequately describe the full breadth of the claimed invention.
Claim Rejections - 35 USC § 102
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mikkelsen et al (US 2016/0186225).
Mikkelsen et al disclose an extract comprising rebaudioside D and/or rebaudioside M at claim 150. The extract of the instant claim would not have been distinguishable from the extract disclosed by Mikkelsen et al. Hence, Mikkelsen et al had previously disclosed the claimed invention.
See In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985), which teaches that a product-by-process claim may be properly rejectable over prior art teaching the same product produced by a different process, if the process of making the product fails to distinguish the two products.
Conclusion
No claims are allowed.
Claims 1-7 and 9-11 appear to be free of the prior art which does not teach the recited polymorphism in the Stevia rebaudiana FRO2. The closest prior art is Markosyan et al (US 2020/0095597) who teaches high Reb M Stevia rebaudiana phenotypes.
Art of intertest related to the instant invention is Connolly et al (Plant Physiology 2003 133:1102-1110) who teach overexpression of the Arabidopsis FRO2 gene and who teaches that FRO2 is subject to posttranscriptional regulation (in the abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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/David H Kruse/
Primary Examiner, Art Unit 1663
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