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 IX in the reply filed on March 12, 2026 is acknowledged.
Applicant did not elect a species.
Applicant also requests the rejoinder of claims 4-18, 16 and 17 in light of the claim amendments.
Because claims 4-18, 16 and 17 as amended are drawn to a plant of claim 22, claims 4-18, 16 and 17 as amended are now drawn to the subject matter of Group IX, and are examined together with claim 22.
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 4 and 17 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.
Claims 4 and 17 are indefinite in the recitation of “wherein the DNA region encoding the ERF is selected from the group consisting of SEQ ID NO: 51-100 and 160”, because SEQ ID NO: 160 is an amino acid sequence, and is therefore a protein region, not a DNA region.
Claims 4 and 17 are also indefinite in the recitation of “wherein the DNA region encoding the PAT1 branch TF is selected from the group consisting of SEQ ID NO: 126-150 and 161”, because SEQ ID NO: 161 is an amino acid sequence, and is therefore a protein region, not a DNA region.
Claims 5 is 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 5 is indefinite in the recitation of “the composition”, because there is insufficient antecedent basis for this limitation in claim 5, or in claim 22 from which claim 5 depends.
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.
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.
Claim(s) 4-8 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over EP 2 719 763 A1 ((VIB VZW [BE]; UNIV GENT [BE]) 16 April 2014 (2014-04-16)).
Claim 22 is drawn to a plant comprising: a first chimeric gene construct, a second chimeric gene construct, and an ERF/PAT1branch TF complex;
the first chimeric gene construct comprising the following operably linked DNA elements:
a) a plant expressible promoter,
b) a DNA region encoding an Ethylene Response Factor (ERF) comprising an
SCL/PAT1 interaction motif, and
c) a 3' end region comprising transcription termination and polyadenylation signals
functioning in cells of the plant, and
the second chimeric gene construct comprising the following operably linked DNA
elements:
a) a plant expressible promoter,
b) a DNA region encoding Phytochrome A Signal Transduction 1 (PAT1) branch TF,
and
c) a 3' end region comprising transcription termination and polyadenylation signals
functioning in cells of the plant wherein the ERF comprising an SCL/PAT1 interaction motif is ERF115 or ERF114, and wherein the PAT1 branch TF is PAT1 or SCL21, and
wherein the plant has increased plant cell regeneration potential without additional hormones as compared to an otherwise identical plant lacking the first chimeric gene construct and the second chimeric gene construct.
In view of the indefiniteness of claim 4 as set forth above, and in the interest of compact prosecution, claim 4 is interpreted here as being drawn to the plant of claim 22, wherein the DNA region encoding the ERF is selected from the group consisting of SEQ ID NO: 51-100 and a DNA region encoding SEQ ID NO:160, and wherein the DNA region encoding the PAT1 branch TF is selected from the group consisting of SEQ ID NO: 126-150 and a DNA region encoding SEQ ID NO:161.
In view of the indefiniteness of claim 5 as set forth above, and in the interest of compact prosecution, claim 5 is interpreted here as being drawn to the plant of claim 22, wherein the first and second chimeric gene constructs are flanked by recombination sites.
Claim 6 is drawn to the plant of claim 22, wherein the chimeric gene constructs are comprised in set of at least one recombinant vector.
Claim 7 is drawn to the plant of claim 22, wherein the plant is a plant, plant cell or
plant seed.
Claim 8 is drawn to the plant of claim 7, wherein ERF and PATI branch TF are co-expressed.
EP 2 719 763 A1 teaches a recombinant plant cell and transgenic plant overexpressing both (coexpression) a gene encoding for an ERF transcription factor and a gene encoding for SCL21, or a homologue, orthologue or paralogue thereof, including a transgenic plant wherein the ERF transcription factor is ERF115, wherein the overexpression can be realized by fusing the gene to a strong promoter, and wherein the ERF transcription factor and SCL21, or a homologue, orthologue or paralogue thereof forms a transcription factor complex that can be used to modulate plant growth, induce stress resistance in a plant, and induce pathogen and/or pest resistance in a plant (paragraph [0010]; claims 1-13).
EP 2 719 763 A1 teaches that the ERF115OE and SCL21OE overexpressing plant lines were generated through recombination of genomic ORFs into the pK7GW2 and pH7GH2 expression vectors under control of the CaMV35S promoter via gateway recombination (paragraph [0012]). A 3’ end region comprising transcription termination and polyadenylation signals functioning in cells of a plant, and flanking recombination sites, are inherent to the expression vectors of a gateway system. See Karimi et al. Gateway vectors for transformation of cereals. Trends Plant Sci. 2013 Jan;18(1):1-4. Epub 2012 Oct 30, Fig. 1.
EP 2 719 763 A1 teaches that plants overexpressing both ERF115 and SCL21 were generated via crossing the individual ERF115OE and SCL21OE overexpressing plant lines, and that the effect of ERF115/SCL21 coexpression on growth was analyzed and found to be dramatic (paragraphs [0029]-[0030]).
While EP 2 719 763 A1 does not explicitly teach increased plant cell regeneration potential without additional hormones as compared to an otherwise identical plant lacking a first and second chimeric gene construct, the plants overexpressing both ERF115 and SCL21 would inherently have this property, because the plants of the prior art and the claimed plants are identical in structure, and the property of increased plant cell regeneration potential without additional hormones is a consequence of this shared structure, i.e. ERF115 and SCL21 coexpressed from the chimeric gene constructs.
The prior art also teaches that the DNA region encoding ERF115 from Arabidopsis thaliana has the nucleotide sequence of SEQ ID NO:51 – see sequence alignment below.
The prior art additionally teaches a DNA region encoding SCL21 from Arabidopsis thaliana - see GenBank Accession No. NM_126521, 08-JUN-2006, Arabidopsis thaliana SCL21(SCARECROW-LIKE 21); transcription factor (SCL21) mRNA, complete cds. The specification at page 57 identifies SEQ ID NO:161, recited in claims 4 and 17, as being the amino acid sequence of Arabidopsis thaliana SCL21.
Accordingly, the claimed invention is anticipated by, or in the alternative, is obvious over EP 2 719 763 A1.
See MPEP 2112 III: “Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA1977).”
See also MPEP 2112.01: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Sequence alignment between SEQ ID NO: 51 and a DNA region encoding ERF115 from Arabidopsis thaliana (see also Heyman et al. ERF115 controls root quiescent center cell division and stem cell replenishment. Science. 2013 Nov 15;342(6160):860-3. Epub 2013 Oct 24, at page 860 column 2 first full paragraph, which identifies At5g07310 as ERF115):
AY560885
LOCUS AY560885 792 bp mRNA linear PLN 14-JUN-2004
DEFINITION Arabidopsis thaliana putative AP2/EREBP transcription factor
(At5g07310) mRNA, complete cds.
ACCESSION AY560885
VERSION AY560885.1
KEYWORDS .
SOURCE Arabidopsis thaliana (thale cress)
ORGANISM Arabidopsis thaliana
Eukaryota; Viridiplantae; Streptophyta; Embryophyta; Tracheophyta;
Spermatophyta; Magnoliophyta; eudicotyledons; Gunneridae;
Pentapetalae; rosids; malvids; Brassicales; Brassicaceae;
Camelineae; Arabidopsis.
REFERENCE 1 (bases 1 to 792)
AUTHORS Pan,Y., Gong,W., Liu,D., Fu,Q., Mei,W.-Q., Song,W.-Q., Ma,L.-G.,
Luo,J.-C., Deng,X.-W. and Zhu,Y.-X.
TITLE Molecular Cloning, Expression, Phylogenetic and Functional
Characterization of the Arabidopsis AP2/EREBP Transcription Factor
Family
JOURNAL Unpublished
REFERENCE 2 (bases 1 to 792)
AUTHORS Pan,Y., Gong,W., Liu,D., Fu,Q., Mei,W.-Q., Song,W.-Q., Ma,L.-G.,
Luo,J.-C., Deng,X.-W. and Zhu,Y.-X.
TITLE Direct Submission
JOURNAL Submitted (26-FEB-2004) College of Life Sciences, The National
Laboratory of Protein Engineering and Plant Genetic Engineering,
Peking University, Beijing, Beijing 100871, P.R. China
FEATURES Location/Qualifiers
source 1..792
/organism="Arabidopsis thaliana"
/mol_type="mRNA"
/db_xref="taxon:3702"
gene 1..792
/locus_tag="At5g07310"
CDS 1..792
/locus_tag="At5g07310"
/codon_start=1
/product="putative AP2/EREBP transcription factor"
/protein_id="AAT44952.1"
/translation="MANSGNYGKRPFRGDESDEKKEADDDENIFPFFSARSQYDMRAM
VSALTQVIGNQSSSHDNNQHQPVVYNQQDPNPPAPPTQDQGLLRKRHYRGVRQRPWGK
WAAEIRDPQKAARVWLGTFETAEAAALAYDNAALKFKGSKAKLNFPERAQLASNTSTT
TGPPNYYSSNNQIYYSNPQTNPQTIPYFNQYYYNQYLHQGGNSNDALSYSLAGGETGG
SMYNHQTLSTTNSSSSGGSSRQQDDEQDYARYLRFGDSSPPNSGF"
Query Match 100.0%; Score 792; DB 316; Length 792;
Best Local Similarity 100.0%;
Matches 792; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ATGGCGAATTCAGGAAATTATGGAAAGAGGCCCTTTCGAGGCGATGAATCGGATGAAAAG 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ATGGCGAATTCAGGAAATTATGGAAAGAGGCCCTTTCGAGGCGATGAATCGGATGAAAAG 60
Qy 61 AAAGAAGCCGATGATGATGAGAACATATTCCCTTTCTTCTCTGCCCGATCCCAATATGAC 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AAAGAAGCCGATGATGATGAGAACATATTCCCTTTCTTCTCTGCCCGATCCCAATATGAC 120
Qy 121 ATGCGTGCCATGGTCTCAGCCTTGACTCAAGTCATTGGAAACCAAAGCAGCTCTCATGAT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ATGCGTGCCATGGTCTCAGCCTTGACTCAAGTCATTGGAAACCAAAGCAGCTCTCATGAT 180
Qy 181 AATAACCAACATCAACCTGTTGTGTATAATCAACAAGATCCTAACCCACCGGCTCCTCCA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 AATAACCAACATCAACCTGTTGTGTATAATCAACAAGATCCTAACCCACCGGCTCCTCCA 240
Qy 241 ACTCAAGATCAAGGGCTATTGAGGAAGAGGCACTATAGAGGGGTAAGACAACGACCATGG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 ACTCAAGATCAAGGGCTATTGAGGAAGAGGCACTATAGAGGGGTAAGACAACGACCATGG 300
Qy 301 GGAAAGTGGGCAGCTGAAATTCGGGATCCGCAAAAGGCAGCACGGGTGTGGCTCGGGACA 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 GGAAAGTGGGCAGCTGAAATTCGGGATCCGCAAAAGGCAGCACGGGTGTGGCTCGGGACA 360
Qy 361 TTTGAGACTGCTGAAGCTGCGGCTTTAGCTTATGATAACGCAGCTCTTAAGTTCAAAGGA 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 TTTGAGACTGCTGAAGCTGCGGCTTTAGCTTATGATAACGCAGCTCTTAAGTTCAAAGGA 420
Qy 421 AGCAAAGCCAAACTCAATTTCCCTGAGAGAGCTCAACTAGCAAGTAACACTAGTACAACT 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 AGCAAAGCCAAACTCAATTTCCCTGAGAGAGCTCAACTAGCAAGTAACACTAGTACAACT 480
Qy 481 ACCGGTCCACCAAACTATTATTCTTCTAATAATCAAATTTACTACTCAAATCCGCAGACT 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 ACCGGTCCACCAAACTATTATTCTTCTAATAATCAAATTTACTACTCAAATCCGCAGACT 540
Qy 541 AATCCGCAAACCATACCTTATTTTAACCAATACTACTATAACCAATATCTTCATCAAGGG 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 AATCCGCAAACCATACCTTATTTTAACCAATACTACTATAACCAATATCTTCATCAAGGG 600
Qy 601 GGGAATAGTAACGATGCATTAAGTTATAGCTTGGCCGGTGGAGAAACCGGAGGCTCAATG 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 GGGAATAGTAACGATGCATTAAGTTATAGCTTGGCCGGTGGAGAAACCGGAGGCTCAATG 660
Qy 661 TATAATCATCAGACGTTATCTACTACAAATTCTTCATCTTCTGGTGGATCTTCAAGGCAA 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 TATAATCATCAGACGTTATCTACTACAAATTCTTCATCTTCTGGTGGATCTTCAAGGCAA 720
Qy 721 CAAGATGATGAACAAGATTACGCCAGATATTTGCGTTTTGGGGATTCTTCACCTCCTAAT 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 CAAGATGATGAACAAGATTACGCCAGATATTTGCGTTTTGGGGATTCTTCACCTCCTAAT 780
Qy 781 TCTGGTTTTTGA 792
||||||||||||
Db 781 TCTGGTTTTTGA 792
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 2 719 763 A1 ((VIB VZW [BE]; UNIV GENT [BE]) 16 April 2014 (2014-04-16)) in view of in view of Gordon-Kamm et al. (U.S. Patent No. 10,968,458, issued Apr. 6, 2021).
Claim 22 is drawn to a plant comprising: a first chimeric gene construct, a second chimeric gene construct, and an ERF/PAT1branch TF complex;
the first chimeric gene construct comprising the following operably linked DNA elements:
a) a plant expressible promoter,
b) a DNA region encoding an Ethylene Response Factor (ERF) comprising an
SCL/PAT1 interaction motif, and
c) a 3' end region comprising transcription termination and polyadenylation signals
functioning in cells of the plant, and
the second chimeric gene construct comprising the following operably linked DNA
elements:
a) a plant expressible promoter,
b) a DNA region encoding Phytochrome A Signal Transduction 1 (PAT1) branch TF,
and
c) a 3' end region comprising transcription termination and polyadenylation signals
functioning in cells of the plant wherein the ERF comprising an SCL/PAT1 interaction motif is ERF115 or ERF114, and wherein the PAT1 branch TF is PAT1 or SCL21, and
wherein the plant has increased plant cell regeneration potential without additional hormones as compared to an otherwise identical plant lacking the first chimeric gene construct and the second chimeric gene construct.
In view of the indefiniteness of claim 5 as set forth above, and in the interest of compact prosecution, claim 5 is interpreted here as being drawn to the plant of claim 22, wherein the first and second chimeric gene constructs are flanked by recombination sites, and wherein the plant further comprises a third chimeric gene construct comprising the following operably linked DNA elements:
a) a plant expressible promoter,
b) a DNA region encoding a site-specific recombinase that is capable of
recognizing and implementing recombination at the recombination sites and
c) a 3' end region comprising transcription termination and polyadenylation
signals functioning in cells of a plant.
EP 2 719 763 A1 teaches a recombinant plant cell and transgenic plant overexpressing both (coexpression) a gene encoding for an ERF transcription factor and a gene encoding for SCL21, or a homologue, orthologue or paralogue thereof, including a transgenic plant wherein the ERF transcription factor is ERF115, wherein the overexpression can be realized by fusing the gene to a strong promoter, and wherein the ERF transcription factor and SCL21, or a homologue, orthologue or paralogue thereof forms a transcription factor complex that can be used to modulate plant growth, induce stress resistance in a plant, and induce pathogen and/or pest resistance in a plant (paragraph [0010]; claims 1-13).
EP 2 719 763 A1 teaches that the ERF115OE and SCL21OE overexpressing plant lines were generated through recombination of genomic ORFs into the pK7GW2 and pH7GH2 expression vectors under control of the CaMV35S promoter via gateway recombination (paragraph [0012]). A 3’ end region comprising transcription termination and polyadenylation signals functioning in cells of a plant, and flanking recombination sites, are inherent to the expression vectors of a gateway system. See Karimi et al. Gateway vectors for transformation of cereals. Trends Plant Sci. 2013 Jan;18(1):1-4. Epub 2012 Oct 30, Fig. 1.
EP 2 719 763 A1 teaches that plants overexpressing both ERF115 and SCL21 were generated via crossing the individual ERF115OE and SCL21OE overexpressing plant lines, and that the effect of ERF115/SCL21 coexpression on growth was analyzed and found to be dramatic (paragraphs [0029]-[0030]).
While EP 2 719 763 A1 does not explicitly teach increased plant cell regeneration potential without additional hormones as compared to an otherwise identical plant lacking a first and second chimeric gene construct, the plants overexpressing both ERF115 and SCL21 would inherently have this property, because the plants of the prior art and the claimed plants are identical in structure, and the property of increased plant cell regeneration potential without additional hormones is a consequence of this shared structure, i.e. ERF115 and SCL21 coexpressed from the chimeric gene constructs.
EP 2 719 763 A1 also teaches that the ERF transcription factor ERF115 and SCL21 form a transcription factor complex that can be used to induce phytosulfokine genes, and that phytosulfokine genes give rise to a sulfonated pentapeptide shown to be involved in callus formation (paragraph [0035]).
EP 2 719 763 A1 does not teach a plant that further comprises a third chimeric gene construct comprising the following operably linked DNA elements:
a) a plant expressible promoter,
b) a DNA region encoding a site-specific recombinase that is capable of
recognizing and implementing recombination at the recombination sites and
c) a 3' end region comprising transcription termination and polyadenylation
signals functioning in cells of a plant.
Gordon-Kamm et al. teach in claim 3 a method for introducing a polynucleotide of interest into a monocot leaf tissue and regenerating a plant therefrom, said method comprising:
a) excising a leaf segment from a leaf above the first leaf base node;
b) dissecting said leaf fragment into leaf tissue;
c) introducing into said leaf tissue: i) a heterologous polynucleotide encoding a cell proliferation factor flanked by recombination sites; ii) an expression cassette comprising a promoter followed by a first attachment B (attB) site, wherein said first attB site is operably linked to a polynucleotide encoding a site-specific recombinase that is capable of recognizing and implementing recombination at said recombination sites; and iii) a polynucleotide of interest;
d) expressing said heterologous polynucleotide encoding said cell proliferation factor;
e) incubating said leaf tissue under conditions to allow for growth of a callus;
f) expressing said polynucleotide encoding said site-specific recombinase, thereby excising said heterologous polynucleotide encoding said cell proliferation factor, and;
g) regenerating a plant from said callus.
Given the teachings of EP 2 719 763 A1 that a recombinant plant cell and transgenic plant overexpressing both a gene encoding for ERF115, and a gene encoding for SCL21 can be made, and that ERF115 and SCL21 form a transcription factor complex that can be used to modulate plant growth, induce stress resistance in a plant, and induce pathogen and/or pest resistance in a plant, given the further teachings of EP 2 719 763 A1 that their transcription factor complex can be used to induce phytosulfokine genes, and that phytosulfokine genes give rise to a sulfonated pentapeptide shown to be involved in callus formation, and given the teachings of Gordon-Kamm et al. that chimeric gene constructs flanked by recombination sites can be excised from a plant cell genome by expressing a site-specific recombinase, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to express ERF115 and SCL21 encoded by chimeric gene constructs that are flanked by recombination sites in conjunction with forming a callus from a plant cell, followed by expressing a recombinase and excising the chimeric gene constructs that are flanked by recombination sites with the recombinase.
One skilled in the art would have recognized that expression of ERF115 and SCL21 would be beneficial during callus formation since one skilled in the art had been apprised that the transcription factor complex can be used to induce phytosulfokine genes that give rise to a sulfonated pentapeptide shown to be involved in callus formation, and one skilled in the art also would have recognized that subsequently expressing a recombinase to excise the chimeric gene constructs as an art recognized means to stop the expression of ERF115 and SCL21 once their expression was no longer needed, as evidence by Gordon-Kamm et al.
Thus, the claimed invention would have been prima facie obvious as a whole to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 2 719 763 A1 ((VIB VZW [BE]; UNIV GENT [BE]) 16 April 2014 (2014-04-16)) in view of Atabekov et al. (U.S. Patent No. 6,376,745, issued Apr. 23, 2002).
Claim 22 is drawn to a plant comprising: a first chimeric gene construct, a second chimeric gene construct, and an ERF/PAT1branch TF complex;
the first chimeric gene construct comprising the following operably linked DNA elements:
a) a plant expressible promoter,
b) a DNA region encoding an Ethylene Response Factor (ERF) comprising an
SCL/PAT1 interaction motif, and
c) a 3' end region comprising transcription termination and polyadenylation signals
functioning in cells of the plant, and
the second chimeric gene construct comprising the following operably linked DNA
elements:
a) a plant expressible promoter,
b) a DNA region encoding Phytochrome A Signal Transduction 1 (PAT1) branch TF,
and
c) a 3' end region comprising transcription termination and polyadenylation signals
functioning in cells of the plant wherein the ERF comprising an SCL/PAT1 interaction motif is ERF115 or ERF114, and wherein the PAT1 branch TF is PAT1 or SCL21, and
wherein the plant has increased plant cell regeneration potential without additional hormones as compared to an otherwise identical plant lacking the first chimeric gene construct and the second chimeric gene construct.
Claim 16 is drawn to the plant of claim 22, wherein the first chimeric gene construct and the second chimeric gene construct form part of a multicistronic gene region; wherein the plant expressible promoters of the first chimeric gene construct and the second chimeric gene construct are the same and wherein the plant expressible promoter promotes transcription of the multicistronic gene region; and wherein the 3' end regions comprising transcription termination and polyadenylation signals functioning in cells of a plant of the first chimeric gene construct and the second chimeric gene construct are the same.
EP 2 719 763 A1 teaches a recombinant plant cell and transgenic plant overexpressing both (coexpression) a gene encoding for an ERF transcription factor and a gene encoding for SCL21, or a homologue, orthologue or paralogue thereof, including a transgenic plant wherein the ERF transcription factor is ERF115, wherein the overexpression can be realized by fusing the gene to a strong promoter, and wherein the ERF transcription factor and SCL21, or a homologue, orthologue or paralogue thereof forms a transcription factor complex that can be used to modulate plant growth, induce stress resistance in a plant, and induce pathogen and/or pest resistance in a plant (paragraph [0010]; claims 1-13).
EP 2 719 763 A1 teaches that the ERF115OE and SCL21OE overexpressing plant lines were generated through recombination of genomic ORFs into the pK7GW2 and pH7GH2 expression vectors under control of the CaMV35S promoter via gateway recombination (paragraph [0012]). A 3’ end region comprising transcription termination and polyadenylation signals functioning in cells of a plant, and flanking recombination sites, are inherent to the expression vectors of a gateway system. See Karimi et al. Gateway vectors for transformation of cereals. Trends Plant Sci. 2013 Jan;18(1):1-4. Epub 2012 Oct 30, Fig. 1.
EP 2 719 763 A1 teaches that plants overexpressing both ERF115 and SCL21 were generated via crossing the individual ERF115OE and SCL21OE overexpressing plant lines, and that the effect of ERF115/SCL21 coexpression on growth was analyzed and found to be dramatic (paragraphs [0029]-[0030]).
While EP 2 719 763 A1 does not explicitly teach increased plant cell regeneration potential without additional hormones as compared to an otherwise identical plant lacking a first and second chimeric gene construct, the plants overexpressing both ERF115 and SCL21 would inherently have this property, because the plants of the prior art and the claimed plants are identical in structure, and the property of increased plant cell regeneration potential without additional hormones is a consequence of this shared structure, i.e. ERF115 and SCL21 coexpressed from the chimeric gene constructs.
EP 2 719 763 A1 does not teach chimeric gene constructs that are part of a multicistronic gene region.
Atabekov et al. teach multicistronic gene constructs for the coexpression of defined gene products in cell culture and transgenic plants and animals.
Given the teachings of EP 2 719 763 A1 that a recombinant plant cell and transgenic plant overexpressing both a gene encoding for ERF115 and a gene encoding for SCL21 can be made, and that ERF115 and SCL21 form a transcription factor complex that can be used to modulate plant growth, induce stress resistance in a plant, and induce pathogen and/or pest resistance in a plant, and given the teachings of Atabekov et al. that multicistronic gene constructs can be used for the coexpression of defined gene products in cell culture and transgenic plants and animals, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to express ERF115 and SCL21 encoded by chimeric gene constructs that are part of a multicistronic gene region.
The use of chimeric gene constructs that are part of a multicistronic gene region, rather than separate chimeric gene constructs, would have been an obvious modifications of experimental design parameters for the production of plants that coexpress multiple gene products, since coexpression of multiple gene products from both separate and multicistronic chimeric gene constructs was known to and practiced by, and therefore within the abilities of, a person having ordinary skill in the art before the effective filing date of the claimed invention.
Thus the claimed invention would have been prima facie obvious as a whole to a person having ordinary skill in the art before the effective filing date of the claimed invention.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 4-8, 16-17 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,939,586. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 4-8, 16-17 and 22 of the instant application, and claims 5-6 and 16 of U.S. Patent No. 11,939,586 are drawn to plants that comprise a first chimeric gene construct, a second chimeric gene construct, and an ERF/PAT1branch TF complex. Claims 4-8, 16-17 and 22 of the instant application, and claims 5-6 and 16 of U.S. Patent No. 11,939,586 differ in that Claims 4-8, 16-17 and 22 of the instant application allows for the ERF comprising an SCL/PAT1 interaction motif to be ERF115 or ERF114, and the PAT1 branch TF to be PAT1 or SCL21, whereas the ERF comprising an SCL/PAT1 interaction motif of claims 5-6 and 16 of U.S. Patent No. 11,939,586 is limited to ERF115, and the PAT1 branch TF is limited to PAT1. The compositions and methods of claims 1-4 and 7-15 of U.S. Patent No. 11,939,586 are similarly limited. Accordingly claims 1-16 of U.S. Patent No. 11,939,586 are, or require components that are, obvious species of the genus of compositions set forth in claims 4-8, 16-17 and 22 of the instant application.
Remarks
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA E COLLINS whose telephone number is (571)272-0794. The examiner can normally be reached M-F 8:30 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, Bratislav Stankovic can be reached at 571-270-0305. 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.
/CYNTHIA E COLLINS/ Primary Examiner, Art Unit 1662
Prosecution Insights