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 .
The objections to claims 1, 10 & 11 are withdrawn in light of Applicant’s amendments.
The rejections of claims 1-8 & 10-15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in light of Applicant’s amendments.
The rejection of claims 1-6, 8, 10-12 & 14 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 & 5-14 of U.S. Patent No. 12,527,270 is withdrawn in light of the Terminal Disclaimer filed 8/11/2026.
The provisional rejection of claims 1-6, 8, 10-12 & 14 on the ground of nonstatutory double patenting over claims 1-3 & 5-14 of copending Application No. 19/450,453 is withdrawn in light of the Terminal Disclaimer filed 8/11/2026.
Status of Claims
Claims 1-8 & 10-15 are under examination on the merits.
Claim Interpretation
Claim 1 and all dependent claims require the cultivating step to be carried out in a medium free of plant hormones. The instant specification defines “plant hormone” as a chemical that influences the growth and development of plant cells and tissues (page 10, lines 29-30). However, the specification continues in the next two sentences to describe that plant growth hormones comprise chemicals from the groups of auxins, cytokinins, gibberellins, abscisic acid and ethylene as well as brassinosteroids and polyamines (page 10, lines 30-34). The broadest interpretation of any chemical that influences plant growth and development would encompass chemicals such as water, sugar, oxygen, and basic salts. Requiring a medium free of all such chemicals would not be a reasonable interpretation of the limitation. For purposes of examination, “plant hormone” has been interpreted to encompass a chemical from the groups provided on page 10 rather than any chemical that influences the growth and development of plant cells and tissues.
Claim Rejections - 35 USC § 112
Written Description
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 12-15 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.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 5/12/2026, as applied to claims 12-15. Applicant' s arguments filed 8/11/2026 have been fully considered but they are not persuasive.
Claim 12 & 14 are drawn to a Beta vulgaris transgenic plant obtained or obtainable by the method of claim 11 or progeny thereof, or a seed or cell of the plant wherein the cell or the seed comprises the nucleotide sequence of interest as a transgene. Claims 13 & 15 are drawn to a modified Beta vulgaris plant obtained or obtainable by the method of claim 11 or progeny thereof, or a seed or cell of the plant wherein the cell or the seed comprises the modification. Claims 14 & 15 require the nucleotide sequence of interest or the modification in the genome but not a coding nucleotide sequence of SEQ ID NO: 1 or encoding a polypeptide of SEQ ID NO: 2.
The instant specification does not define “progeny”, so it is not definite whether progeny is limited to first generation progeny or any generation. First generation progeny of an inbred line may be considered described, because one set of the inherited genome is known in all first-generation progeny. Amended claim 11 requires that the Beta vulgaris plant is inbred or homozygous for the introduced nucleotide sequence of interest or the modification. However, because of crossing over, later generation progeny of even an inbred line will not necessarily share any common genetic component. A plant that is a progeny of the plant produced by the method of claim 11 multiple generations removed may not share any traits in common with the plant produced by the method of claim 11 and may not still be inbred or homozygous. The method does not require a specific Beta vulgaris genetic background, only that the plant is inbred, and does not require any specific nucleotide of interest or modification.
Claims 12-15 are product by process claims, which are not limited to the manipulations of the recited steps but only the structure implied by the steps (MPEP 2113(I)). No such shared structure would necessarily be present in plants produced by the method of claim 11 and progeny thereof, and in cells and seeds of the plant or progeny. The claims encompass any Beta vulgaris, or in claims 14 & 15, any Beta vulgaris comprising any specific nucleotide of interest as a transgene or modification.
The instant specification teaches plants recovered from the claimed method (page 46, lines 1-21) and that they are fertile and produce seeds (page 47, lines 28-page 48, line 11, figure 25). No further generations of progeny are described and no structural features of the plants and progeny thereof are described.
One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus.
Applicant urges, with respect to the rejections under 35 U.S.C. 112, that the amended claims address the antecedent basis of the identified limitations and render the rejection moot (Remarks, page 7, paragraph 8-page 8, paragraph 1).
This argument is unpersuasive to the rejection under 35 U.S.C. 112(a), because the amended claims still do not require any structural feature such that one of ordinary skill in the art would be able to recognize plants, progeny, cells, or seeds belonging to the genus of plants produced by the method of claim 11. One of ordinary skill in the art would still not be able to recognize that Applicant was in possession of all plants encompassed by the claims at the time of filing.
New Matter
Claims 11-15 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. This is a New Matter rejection.
Amended claim 11 and dependent claims 12-15 require that the transgenic plant and/or the modified plant resulting from steps C1 or C2 is inbred or homozygous for the introduced nucleotide sequence of interest or a modification.
The originally filed specification does not describe Beta vulgaris plants which are inbred or homozygous for an introduced nucleotide sequence of interest or a modification. This limitation constitutes New Matter. In response to this rejection, Applicant is required to point specifically to support for the concept in the specification or to cancel the New Matter.
Applicant urges that no new matter is added by way of this amendment (Remarks, page 7, paragraph 2).
This argument is unpersuasive because the originally filed specification and claims do not describe Beta vulgaris plants which are inbred or homozygous for an introduced nucleotide sequence of interest or a modification.
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 (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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 12 & 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by D’Halluin et al (1992) Bio/Technology. 10: 309-314 (published 3/1/1992, hereafter D’Halluin).
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 5/12/2026, as applied to claims 12 & 14. Applicant' s arguments filed 8/11/2026 have been fully considered but they are not persuasive.
Claim 12 & 14 are drawn to a Beta vulgaris transgenic plant obtained or obtainable by the method of claim 11 or progeny thereof, or a seed or cell of the plant wherein the cell or seed comprises the at least one nucleotide sequence of interest.
Claims 12 & 14 are product by process claims, which are not limited to the manipulations of the recited steps but only the structure implied by the steps (MPEP 2113(I)). The instant specification does not define “progeny” to be within a specific number of generations or to comprise any distinguishing structural features. The method of claim 11 requires that the Beta vulgaris plant be inbred or homozygous for the modification or the introduced nucleotide sequence of interest. However, because of crossing over and recombination, no shared structure would necessarily be present in progeny of plants produced by the method of claim 11 for any generation after the first. Moreover, the method does not require a specific Beta vulgaris genetic background, only that the plant is inbred and homozygous, and does not require any specific nucleotide of interest or modification. The only shared structure, in claim 14, is any at least one nucleotide sequence of interest as a transgene.
Thus, claims 12 & 14 only require a Beta vulgaris plant, seed, or cell, that is transgenic.
D'Halluin discloses transgenic Beta vulgaris plants expressing an ALS gene that are resistant to herbicide (page 309, right column, paragraph 4-page 310, right column, paragraph 1; page 311, left column, paragraph 1). D’Halluin discloses seed set from the transformed plants (page 311, left column, paragraph 4). The S1 progeny carrying transgenes were evaluated in the field and were not damaged due to herbicide application (page 312, left column, paragraph 3-right column, paragraph 2).
The transgenic Beta vulgaris plants of D’Halluin read on the plant obtainable by the method of claim 11 or progeny plant thereof (instant claim 12) and the seeds of D’Halluin read on seeds comprising at least one nucleotide sequence of interest as a transgene (instant claim 14).
Applicant urges that claim 11 is amended to recite that the transgenic plant resulting from step C1 is inbred or homozygous for the introduced nucleotide sequence of interest and/or the modified plant resulting from step C2 is inbred or homozygous for the modification. Applicant urges that the shared structure is therefore necessarily present in progeny or seeds of plants produced by the method, making the plants in claims 12-15 structurally distinct from the plants of D’Halluin (Remarks, page 8, paragraph 5).
This argument is unpersuasive, because the term progeny encompasses plants more than 1 generation removed from the transformed plant, including progeny which result from crosses with different genetic backgrounds from the original plant produced by claim 11. Progeny of later generations of even inbred or homozygous plants produced by claim 11 will not necessarily comprise the introduced nucleotide sequence of interest or the modification (claims 12 & 13).
Secondly, the shared structure of a nucleotide sequence of interest as a transgene (claim 14) or a modification in the genome (claim 15) is not limited to any specific transgene or modification. The method of claim 11 would not impart any characteristics, especially in subsequent generations, that would be distinguishable from any other method of transformation or genome modification of Beta vulgaris. Therefore, any Beta vulgaris plant cell or seed comprising a transgene or a modification in the genome would be indistinguishable from and read on the plant cell or seeds of claims 14 & 15.
Claim(s) 12- 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hegelund US 11,266,087 B1 (hereafter Hegelund; patented 3/8/2022 with a U.S. filing date of 10/2/2020 prior to the effective filing date of the instant application).
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 5/12/2026, as applied to claims 13 & 15. Applicant' s arguments filed 8/11/2026 have been fully considered but they are not persuasive.
Claims 13 & 15 are drawn to a modified Beta vulgaris plant obtained or obtainable by the method of claim 11 or progeny thereof, or a seed or cell of the plant. Claim 15 requires that the cell or seed comprises the modification in the genome. Claim 12 & 14 are drawn to a Beta vulgaris transgenic plant obtained or obtainable by the method of claim 11 or progeny thereof, or a seed or cell of the plant.
Claims 12-15 are product by process claims, which are not limited to the manipulations of the recited steps but only the structure implied by the steps (MPEP 2113(I)). The instant specification does not define “progeny” to be within a specific number of generations or to comprise any distinguishing structural features. The method of amended claim 11 requires that the Beta vulgaris plant be inbred or homozygous for the modification or the introduced nucleotide sequence of interest. However, because of crossing over and recombination, no shared structure would necessarily be present in progeny after the first generation of plants produced by the method of claim 11. Thus, claims 13 & 15 only require a modified Beta vulgaris plant, seed, or cell, and, in the case of claim 15, comprises a modification in the genome, while claims 12 & 14 only require a transgenic Beta vulgaris plant, seed, or cell which, in the case of claim 14, comprises the nucleotide sequence of interest as a transgene.
Hegelund discloses a beet plant comprising a single locus conversion, including wherein the single locus conversion confers herbicide resistance and wherein the conversion is introduced into the plant by the methods of Zinc Finger Nuclease technology, genetic transformation, Transcription Activation-Like Effector Nuclease (TALENs) CRISPR/Cas system and DNA guided genome editing (Hegelund claims 20-22). Hegelund describes a single locus conversion as allowing for one or more site specific changes to the plant genome such as nucleotide change, deletions, insertions, and substitutions (column 6, line 57-column 7, line 19). Hegelund defines single locus converted plants as those in which essentially all of the desired morphological and physiological characteristics of a plant are recovered in addition to a single locus transferred into the plant via backcrossing or genetic engineering (column 16, lines 58-64).
The beet plant of Hegelund comprising a single locus conversion introduced by DNA guided genome editing reads on a modified Beta vulgaris plant obtainable by the method of claim 11 or progeny plant thereof (instant claim 13) while the plant comprising a single locus conversion introduced by genetic transformation reads on a transgenic Beta vulgaris plant obtained or obtainable by the method of claim 11 (instant claim 12). Because the plants of Hegelund would inherently comprise cells, the plant cells of instant claims 14 & 15 are also anticipated by Hegelund.
Thus, claims 12-15 are anticipated by Hegelund.
Applicant urges that claim 11 is amended to recite that the transgenic plant resulting from step C1 is inbred or homozygous for the introduced nucleotide sequence of interest and/or the modified plant resulting from step C2 is inbred or homozygous for the modification. Applicant urges that the shared structure is therefore necessarily present in progeny or seeds of plants produced by the method, making the plants in claims 12-15 structurally distinct from the plants of Hegelund (Remarks, page 8, paragraph 5).
This argument is unpersuasive, because the term progeny encompasses plants more than 1 generation removed from the transformed plant, including progeny which result from crosses with different genetic backgrounds from the original plant produced by claim 11. Progeny of later generations of even inbred or homozygous plants produced by claim 11 will not necessarily comprise the introduced nucleotide sequence of interest or the modification (claims 12 & 13).
Secondly, the shared structure of a nucleotide sequence of interest as a transgene (claim 14) or a modification in the genome (claim 15) is not limited to any specific transgene or modification. The method of claim 11 would not impart any characteristics, especially on subsequent generations, that would be distinguishable from any other method of transformation or genome modification of Beta vulgaris. Therefore, any Beta vulgaris plant cell or seed comprising a transgene or a modification in the genome would be indistinguishable from and read on the plant cell or seeds of claims 14 & 15.
Conclusion
Claims 1-8 & 10 are allowed. Claims 11-15 are rejected.
The following is a statement of reasons for the indication of allowable subject matter:
The instant claims require a nucleotide of SEQ ID NO: 1 or a nucleotide sequence encoding a polypeptide having the amino acid sequence of SEQ ID NO: 2. Although the prior art teaches methods of organogenesis or embryogenesis of Beta vulgaris, including on a medium free of plant hormones, and the prior art also teaches transformation with polynucleotide sequences encoding a Babyboom polypeptide with >99% sequence identity to SEQ ID NO: 2, the prior art does not teach an expression cassette comprising a nucleotide sequence encoding SEQ ID NO: 2.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Victoria L DeLeo whose telephone number is (703)756-5998. The examiner can normally be reached M-F 8:00am-4pm EDT.
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/VICTORIA L DELEO/Examiner, Art Unit 1662
/Anne Kubelik/Primary Examiner, Art Unit 1663
