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
In response to the restriction requirement mailed April 1, 2026, Applicant elected Group IV, directed to modified soybean plants having a mutated E1 or E1LB locus, and further elected the E1 locus species.
Claims 32 and 39 have been amended, and claims 37 and 43 has been canceled. Claims 32 and 39 are directed to the elected Group IV invention and the elected E1 species and are examined on the merits in this office Action.
Claim 45 is directed to the non-elected E1LB locus species and remains withdrawn from consideration pursuant to the species election.
Claims 1, 5, 8, 12-15, 17, 19-21, 23, and 25-29 remain withdrawn from consideration pursuant to the restriction requirement.
Applicant’s request for rejoinder is noted, Rejoinder of otherwise proper withdrawn claims will be considered if the elected claims become allowable and the applicable requirements for rejoinder are satisfied.
Claim Status
Claims 1, 5, 8, 12-15, 17, 19-21, 23, 25-29, and 45 are withdrawn from consideration.
Claims 37 and 43 is canceled.
Claims 32 and 39 are examined on the merits.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 32 and 39 are rejected under 35 U.S.C. §103 as being unpatentable over Han (Jianan Han et. al., Frontiers in Plant Science (2019) Vol 10 (1446), pp1-10).
Claim 32 recites a modified soybean plant, comprising a non-naturally occurring mutant allele at an E1 locus via genome modification, and wherein said mutant allele at the E1 locus comprises a homozygous mutation selected from the group consisting of: (a)deletion of 8bp from position 147 to 154 of the E1 gene; (b)deletion of 13bp from position 144 to 156 of the E1 gene; (c)deletion of 25bp from position 131 to 155 of the E1 gene; and(d)deletion of 9bp from position 146 to 154 of the E1 gene; and (e)substitution of 15bp from position 145 to 159 of the E1 gene, wherein said position is with reference to the E1 gene of SEQ ID NO. 1.
Han teaches a modified soybean plant, or plant part thereof, comprising a non-naturally occurring mutant allele at the E1 locus (p1, Abstract). Han identifies the soybean E1 gene as Glyma.06G207800 and introduces mutations into the E1 coding region using a CRISPR/Cas9 expression vector comprising Cas9 and guide RNAs directed to the E1 gene (Abstract, p2, right column “CRISPR/Cas9 Expression Vector Construction”; p3, right column “CRISPR/Cas9-Mediated Mutations”)
Sequence comparison demonstrates that the E1 sequence edited by Han corresponds to the E1 gene of instant SEQ ID NO: 1, with only one nucleotide difference across the full-length 582-nucleotide aligned region (see alignment below). Accordingly, Han teaches genome modification of the same E1 locus recited in claim 32.
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Han further teaches recovering soybean plants having homozygous E1 mutant alleles (p3, right column, pa3). In particular, Han obtained homozygous mutants containing an 11-bp deletion or a 40-bp deletion in the E1 coding region (p4 left column, pa1), named e1-1 and e1-2, 11 bp deletion and 40 bp deletion, respectively. All of them were frameshift mutations, resulting in premature translation termination codons, and truncated E1 proteins (Supplementary Figure 3 and 4, also see below). The e1-1 allele encoded a truncated 79-amino-acid protein lacking the B3 domain, while the e1-2 allele encoded a truncated 88-animo-acid protein lacking the nuclear-localization signal and B3 domain (p3, right column “CRISPR/Cas9-Mediated Mutations”, Table 1).
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Han also teaches that the two structurally different E1 deletion alleles produced the same expected functional results. Both alleles disrupted functional E1 protein and produced homozygous mutant soybean plants having significantly earlier lowering dunder long-day conditions. Han reports that wild-type plants flowered at approximately 57 days, whereas the homozygous E1 mutants flowered at approximately 37-39 days (Table 3; Figure 4; p4, right column “Inheritance analysis and Phenotype Identification”).
Han does not expressly teach that the homozygous E1 mutant allele comprises the specifically recited :
(a)deletion of 8 bp at position 147 to 154 of the E1 gene;
(b)deletion of 13 bp at position 144 to 156 of the E1 gene;
(c)deletion of 25 bp at position 131 to 155 of the E1 gene;
(d)deletion of 9 bp at position 146 to 154 of the E1 gene;
(e)substitution of 15 bp at position 145 to 159 of the E1 gene;
Wherein the positions are defined with reference to SEQ ID NO: 1.
Han teaches that CRISPR/Cas9 editing of the E1 coding region produces multiple, structurally different mutant alleles that may be identified by sequencing and selected in homozygous form. Han further demonstrated that different deletion size in the E1 coding sequence predictably produce altered E1 proteins having reduced or eliminated E1 function, and the same desired early-flowering phenotype. Thus, Han teaches that the precise size of the E1 mutation need not be identical for the mutation to alter E1 function and produce the desired biological results.
It would have been obvious to a person of ordinary skill in the art at the relevant time to generate and screen additional CRISPR/Cas9-edited soybean plants at the E1 locus and to select a homozygous plant having another deletion or substitution in the same E1 coding region, including one of the mutations recited in claim 32. A skilled artisan would have been motivated to do so because Han expressly teaches using CRISPR/Cas9 to create novel E1 mutation types, sequencing the resulting mutations, and selecting alleles that reduce or eliminate E1 function and confer early flowering.
A person of ordinary skill would have had a reasonable expectation of success because Han demonstrates that two independent and structurally different deletion alleles, e1-1 and e1-2, both produce premature truncation of E1, eliminate critical functional domains, and generated the same early-flowering phenotype. Accordingly, the claimed mutations represent predictable alternative E1-loss-of-function or reduced-function alleles obtainable through routine generation, sequencing, and selection of CRISPR-edited soybean plants.
Therefore, claim 32 would have been obvious over Han.
Claim 39 recites the modified soybean plant, or plant part thereof, of claim 32, wherein said modified plant has a smaller flowering time or a smaller maturity time, or both, than that of a control plant comprising an unmodified wild-type E1 and/or wild-type E1LB gene allele.
For the same reason set forth above with respect to claim 32, and further as follows.
Han teaches that the homozygous CRISPR/Cas9-induced E1 mutant soybean plants exhibited a shorter flowering time than a control soybean plant comprising an unmodified wild-type E1 allele (Fig 4). Han measured flowering time from seedling emergence to the R1 stage, defined as the appearance of the first flower on any node of the main stem (p2, right column “plant Materials and Growth Conditions”).
Under long-day conditions, Han reports that the wild-type soybean plants flowered at an average of approximately 57 days, whereas the homozygous E1 mutant plants derived from lines L7, L9, and L16 flowered at approximately 39, 38, and 37 days, respectively. Han further states that the flowering time of the homozygous E1 mutants was significantly earlier than that of the wild-type control plants (Fig 4A-B; p4, right column “Inheritance analysis and Phenotype
Identification”),
Accordingly, Han teaches the additional limitation of claim 39 that the modified soybean plant has a shorter flowering time than a control plant comprising an unmodified wild-type E1 allele. Because claim 39 recites a smaller flowering time or smaller maturity time, Han’s disclosure of a smaller flowering time or a smaller maturity time satisfies the claimed alternative.
Therefore, claim 39 would have been obvious over Han.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YANXIN SHEN whose telephone number is (571)272-7538. The examiner can normally be reached Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at (571)272-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YANXIN SHEN/ Examiner, Art Unit 1663
/WEIHUA FAN/ Primary Examiner, Art Unit 1663
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