DETAILED ACTION
Applicant’s election without traverse of Group I (claims 1-2 and 4-8) in the reply filed on 3 February 2026 is acknowledged.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The priority date for the instant claim 2 is the date of the filing of PCT/US2021/044198, the PCT upon which this application and its parent are based. SEQ ID NO:25 first appears in PCT/US2021/044198 and is not present in any of the provisional applications to which this application claims priority.
Claim Objections
Claims 7-8 are objected to because of the following informalities:
In claims 7-8, either --, said method-- or --the method- should be inserted after “seed”, as currently the comprising phrase modifies “seed” instead of “method”.
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 the second paragraph of 35 U.S.C. 112:
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 1-2 and 4-8 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 that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention. Dependent claims are included in all rejections.
Claim 1 lacks antecedent basis for the following limitations: “the Cry1F” and “the … Cry34Ab1” in line 2, “the … Cry35Ab1 genes” in lines 2-3, “the DP-4114 transgenic locus” in line 3, “the 3' DNA junction polynucleotide” in lines 3-4, and “the … phosphinotricin acetyltransferase (PAT) selectable marker gene” in line 4.
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 1 and 4-8 are rejected under 35 U.S.C. 103(a) as being unpatentable over Diehn et al (2013, US 8,575,434) in view of Srivastava et al (2017, Plant Cell Tiss. Organ Cult. 129:153-160).
The claims are drawn to a maize plant or plant cell comprising an INIR6 locus that is a truncation of DP-4114 in which the PAT gene cassette is deleted.
Diehn et al teach maize event DP-004114-3, which the instant application calls DP-4114 (instant ¶3). Their SEQ ID NO:6 is the sequence of the event and is identical to the instant SEQ ID NO:1 (alignment available upon request). It consists of 2422 bp 5’ genomic border sequence, 11,925 bp insert, 2405 bp 3’ genomic border sequence (paragraph spanning columns 31-32). The insert is shown in Table 1, but lacks 29 bp at the right border and 24 bp at the left border (column 32, lines 2-4). The insert has expression cassettes for Bt toxins cry1F, cry34Ab1, and cry35Ab1 and herbicide resistance protein phosphinothricin acetyltransferase (PAT) (Table 1)
The exact bases of the prior art’s SEQ ID NO:6/instant SEQ ID NO:1 that correspond to the PAT cassette are as follows:
Element
Bases of ‘434’s SEQ ID NO:5
Bases of instant SEQ ID NO:1
Polylinker
10323-10367
12716-12760
CaMV35S promoter
10368-10897
12717-13290
Polylinker
10898-10916
13291-13309
Pat gene
10917-11468
13310-13861
Polylinker
11469-11488
13862-13881
CaMV35S terminator
11489-11680
13882-14073
Polylinker
11681-11756
14074-14149
Ti plasmid
11757-11953
14150-14346
Left border
11954
11347
Diehn et al claim maize plants and seeds comprising the event (claims 6 and 8); the plants comprise plant cells comprising the event. Diehn et al also claim a method of obtaining hybrid plants with the event, comprising crossing maize plants with the event to plants of a different genotype (claim 21).
Diehn et al do not teach a maize plant or plant cell comprising a truncation of DP-4114 in which the PAT gene cassette is deleted.
Srivastava et al teach a method for the precise deletion of a gene. It uses CRISPR Cas9 and gRNAs that target the ends of the gene they wish to excise, in their case a transgenic construct encoding GUS (paragraph spanning the columns on pg 154). They teach the construction of a construct comprising the two gRNAs that target GUS and transformation of it and a construct encoding CRISPR Cas9 into plants (pg 154, right column, paragraph 2; Table 1; Figure 1). The gene was excised in the callus phase (pg 156, right column, paragraph 2) and plants produced (pg 157, left column, paragraph 2). The gRNAs were designed to take advantage of CRISPR Cas9 TGG and CGG PAM sites near the 5’ and 3’ ends of the GUS gene (Table 1; Figure 1a).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to delete the PAT gene from the maize DP-4114 event taught by Diehn et al using the method described in Srivastava et al. One of ordinary skill in the art would have been motivated to do so to allow the plants to be retransformed with an additional construct via use the same marker gene(Srivastava et al, pg 153, right column, paragraph 1).
One of ordinary skill in the art would design the gRNAs to take advantage of CRISPR Cas9 TGG PAM sites near the 5’ and 3’ ends of the PAT gene construct in the DP-4114 event. Below, two possible such gRNAs are underlined and the TGG PAM sites are in bold:
Qy 12654 TAATCATATATAATTAATATCAATTGGGTTAGCAAAACAAATCTAGTCTAGGTGTGTTTT 12713
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 10261 TAATCATATATAATTAATATCAATTGGGTTAGCAAAACAAATCTAGTCTAGGTGTGTTTT 10320
Qy 12714 GCGAATTATCGATGGGCCCCGGCCGAAGCTGGCCGCGGACCGAATTCCCATGGAGTCAAA 12773
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 10321 GCGAATTATCGATGGGCCCCGGCCGAAGCTGGCCGCGGACCGAATTCCCATGGAGTCAAA 10380
Qy 12774 GATTCAAATAGAGGACCTAACAGAACTCGCCGTAAAGACTGGCGAACAGTTCATACAGAG 12833
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 10381 GATTCAAATAGAGGACCTAACAGAACTCGCCGTAAAGACTGGCGAACAGTTCATACAGAG 10440
Qy 12834 TCTCTTACGACTCAATGACAAGAAGAAAATCTTCGTCAACATGGTGGAGCACGACACGCT 12893
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 10441 TCTCTTACGACTCAATGACAAGAAGAAAATCTTCGTCAACATGGTGGAGCACGACACGCT 10500
Qy 12894 TGTCTACTCCAAAAATATCAAAGATACAGTCTCAGAAGACCAAAGGGCAATTGAGACTTT 12953
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 10501 TGTCTACTCCAAAAATATCAAAGATACAGTCTCAGAAGACCAAAGGGCAATTGAGACTTT 10560
Qy 12954 TCAACAAAGGGTAATATCCGGAAACCTCCTCGGATTCCATTGCCCAGCTATCTGTCACTT 13013
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 10561 TCAACAAAGGGTAATATCCGGAAACCTCCTCGGATTCCATTGCCCAGCTATCTGTCACTT 10620
Qy 13014 TATTGTGAAGATAGTGGAAAAGGAAGGTGGCTCCTACAAATGCCATCATTGCGATAAAGG 13073
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 10621 TATTGTGAAGATAGTGGAAAAGGAAGGTGGCTCCTACAAATGCCATCATTGCGATAAAGG 10680
Qy 13074 AAAGGCCATCGTTGAAGATGCCTCTGCCGACAGTGGTCCCAAAGATGGACCCCCACCCAC 13133
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 10681 AAAGGCCATCGTTGAAGATGCCTCTGCCGACAGTGGTCCCAAAGATGGACCCCCACCCAC 10740
Qy 13134 GAGGAGCATCGTGGAAAAAGAAGACGTTCCAACCACGTCTTCAAAGCAAGTGGATTGATG 13193
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 10741 GAGGAGCATCGTGGAAAAAGAAGACGTTCCAACCACGTCTTCAAAGCAAGTGGATTGATG 10800
Qy 13194 TGATATCTCCACTGACGTAAGGGATGACGCACAATCCCACTATCCTTCGCAAGACCCTTC 13253
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 10801 TGATATCTCCACTGACGTAAGGGATGACGCACAATCCCACTATCCTTCGCAAGACCCTTC 10860
Qy 13254 CTCTATATAAGGAAGTTCATTTCATTTGGAGAGGACAGGGTACCCGGGGATCCACCATGT 13313
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 10861 CTCTATATAAGGAAGTTCATTTCATTTGGAGAGGACAGGGTACCCGGGGATCCACCATGT 10920
Qy 13314 CTCCGGAGAGGAGACCAGTTGAGATTAGGCCAGCTACAGCAGCTGATATGGCCGCGGTTT 13373
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 10921 CTCCGGAGAGGAGACCAGTTGAGATTAGGCCAGCTACAGCAGCTGATATGGCCGCGGTTT 10980
Qy 13374 GTGATATCGTTAACCATTACATTGAGACGTCTACAGTGAACTTTAGGACAGAGCCACAAA 13433
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 10981 GTGATATCGTTAACCATTACATTGAGACGTCTACAGTGAACTTTAGGACAGAGCCACAAA 11040
Qy 13434 CACCACAAGAGTGGATTGATGATCTAGAGAGGTTGCAAGATAGATACCCTTGGTTGGTTG 13493
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 11041 CACCACAAGAGTGGATTGATGATCTAGAGAGGTTGCAAGATAGATACCCTTGGTTGGTTG 11100
Qy 13494 CTGAGGTTGAGGGTGTTGTGGCTGGTATTGCTTACGCTGGGCCCTGGAAGGCTAGGAACG 13553
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 11101 CTGAGGTTGAGGGTGTTGTGGCTGGTATTGCTTACGCTGGGCCCTGGAAGGCTAGGAACG 11160
Qy 13554 CTTACGATTGGACAGTTGAGAGTACTGTTTACGTGTCACATAGGCATCAAAGGTTGGGCC 13613
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 11161 CTTACGATTGGACAGTTGAGAGTACTGTTTACGTGTCACATAGGCATCAAAGGTTGGGCC 11220
Qy 13614 TAGGATCCACATTGTACACACATTTGCTTAAGTCTATGGAGGCGCAAGGTTTTAAGTCTG 13673
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 11221 TAGGATCCACATTGTACACACATTTGCTTAAGTCTATGGAGGCGCAAGGTTTTAAGTCTG 11280
Qy 13674 TGGTTGCTGTTATAGGCCTTCCAAACGATCCATCTGTTAGGTTGCATGAGGCTTTGGGAT 13733
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 11281 TGGTTGCTGTTATAGGCCTTCCAAACGATCCATCTGTTAGGTTGCATGAGGCTTTGGGAT 11340
Qy 13734 ACACAGCCCGGGGTACATTGCGCGCAGCTGGATACAAGCATGGTGGATGGCATGATGTTG 13793
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 11341 ACACAGCCCGGGGTACATTGCGCGCAGCTGGATACAAGCATGGTGGATGGCATGATGTTG 11400
Qy 13794 GTTTTTGGCAAAGGGATTTTGAGTTGCCAGCTCCTCCAAGGCCAGTTAGGCCAGTTACCC 13853
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 11401 GTTTTTGGCAAAGGGATTTTGAGTTGCCAGCTCCTCCAAGGCCAGTTAGGCCAGTTACCC 11460
Qy 13854 AGATCTGAGTCGACCTGCAGGCATGCCCGCTGAAATCACCAGTCTCTCTCTACAAATCTA 13913
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 11461 AGATCTGAGTCGACCTGCAGGCATGCCCGCTGAAATCACCAGTCTCTCTCTACAAATCTA 11520
Qy 13914 TCTCTCTCTATAATAATGTGTGAGTAGTTCCCAGATAAGGGAATTAGGGTTCTTATAGGG 13973
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 11521 TCTCTCTCTATAATAATGTGTGAGTAGTTCCCAGATAAGGGAATTAGGGTTCTTATAGGG 11580
Qy 13974 TTTCGCTCATGTGTTGAGCATATAAGAAACCCTTAGTATGTATTTGTATTTGTAAAATAC 14033
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 11581 TTTCGCTCATGTGTTGAGCATATAAGAAACCCTTAGTATGTATTTGTATTTGTAAAATAC 11640
Qy 14034 TTCTATCAATAAAATTTCTAATTCCTAAAACCAAAATCCAGGGCGAGCTCGAATTCGAGC 14093
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 11641 TTCTATCAATAAAATTTCTAATTCCTAAAACCAAAATCCAGGGCGAGCTCGAATTCGAGC 11700
Qy 14094 TCGAGCCCGGGTGGATCCTCTAGAGTCGACCTGCAGAAGCTTCGGTCCGGCGCGCCTCTA 14153
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 11701 TCGAGCCCGGGTGGATCCTCTAGAGTCGACCTGCAGAAGCTTCGGTCCGGCGCGCCTCTA 11760
Qy 14154 GTTGAAGACACGTTCATGTCTTCATCGTAAGAAGACACTCAGTAGTCTTCGGCCAGAATG 14213
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 11761 GTTGAAGACACGTTCATGTCTTCATCGTAAGAAGACACTCAGTAGTCTTCGGCCAGAATG 11820
Qy 14214 GCCTAACTCAAGGCCATCGTGGCCTCTTGCTCTTCAGGATGAAGAGCTATGTTTAAACGT 14273
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 11821 GCCTAACTCAAGGCCATCGTGGCCTCTTGCTCTTCAGGATGAAGAGCTATGTTTAAACGT 11880
Qy 14274 GCAAGCGCTACTAGACAATTCAGTACATTAAAAACGTCCGCAATGTGTTATTAAGTTGTC 14333
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 11881 GCAAGCGCTACTAGACAATTCAGTACATTAAAAACGTCCGCAATGTGTTATTAAGTTGTC 11940
Qy 14334 TAAGCGTCAATTTGGAACAAGTGGCTATCGCCAGATATAAGAACTTCGATCCGAAATATC 14393
||||||||||||||
Db 11941 TAAGCGTCAATTTG 11954
Because the gRNAs span the PAT gene, after excision it would be deleted, producing maize plants comprising a truncation of DP-4114 in which the PAT gene cassette is deleted but retaining the cry1F, cry34Ab1, and cry35Ab1 expression cassettes.
It would have been obvious to one of ordinary skill in the art to self the resulting plants to generate more seed and plants with the truncated event. It also would have been obvious to one of ordinary skill in the art to cross the resulting plants to plants of a different genotype to transfer the truncated event into other maize plants of other genetic backgrounds.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Diehn et al in view of Srivastava et al as applied to claims 1 and 4-8 above, and further in view of Schaart et al (WO 2019/238772).
The claim is drawn to a transgenic maize plant with an INIR6 locus comprising SEQ ID NO:25, which is a truncation of DP-4114 in which the PAT gene cassette is deleted at particular sites.
The teachings of Diehn et al in view of Srivastava et al are discussed above.
Diehn et al in view of Srivastava et al do not teach a maize plant or plant cell comprising a truncation of DP-4114 in which the PAT gene cassette is deleted to form SEQ ID NO:25.
Schaart et al teaches excision of a selectable marker in tobacco using Cpf1 (aka CRISPR Cas12a) (example 1). Schaart et al teaches the PAM site for Cpf1 (TTTN) and the crRNA recognition site (pg 11, lines 12-23). They teach how to construct constructs appropriate for excising the gene of interest, introduction into tobacco, and plants with the marker excised (pg 36, line 5, to pg 38, line 8; Figure 4, 11; pg 38, line 10, to pg 41, line 9; pg 42, line 22, to pg 53, line 11).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the method of deleting the PAT gene from the maize DP-4114 event, and products produced, made obvious by Diehn et al in view of Srivastava et al to use CRISPR Cas12a as described in Schaart et al. One of ordinary skill in the art would have been motivated to do so substitution of one enzyme for another is a design choice/
There are suitable PAM sites in the polylinkers just upstream and downstream of the PAT gene cassette in the DP-4114 event. They are shown below in bold in the alignment of instant SEQ ID NO:25 against instant SEQ ID NO:1; the crRNAs one of ordinary skill in the art would use are underlined.
Qy 12601 TCTTTGATGAACCAGATGCATTTCATTAACCAAATCCATATACATATAAATATTAATCAT 12660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 12601 TCTTTGATGAACCAGATGCATTTCATTAACCAAATCCATATACATATAAATATTAATCAT 12660
Qy 12661 ATATAATTAATATCAATTGGGTTAGCAAAACAAATCTAGTCTAGGTGTGTTTTGCGAATT 12720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 12661 ATATAATTAATATCAATTGGGTTAGCAAAACAAATCTAGTCTAGGTGTGTTTTGCGAATT 12720
Qy 12721 ATCGATGGGCCCC----------------------------------------------- 12733
|||||||||||||
Db 12721 ATCGATGGGCCCCGGCCGAAGCTGGCCGCGGACCGAATTCCCATGGAGTCAAAGATTCAA 12780
Qy 12734 ------------------------------------------------------------ 12733
Db 12781 ATAGAGGACCTAACAGAACTCGCCGTAAAGACTGGCGAACAGTTCATACAGAGTCTCTTA 12840
Qy 12734 ------------------------------------------------------------ 12733
Db 12841 CGACTCAATGACAAGAAGAAAATCTTCGTCAACATGGTGGAGCACGACACGCTTGTCTAC 12900
Qy 12734 ------------------------------------------------------------ 12733
Db 12901 TCCAAAAATATCAAAGATACAGTCTCAGAAGACCAAAGGGCAATTGAGACTTTTCAACAA 12960
Qy 12734 ------------------------------------------------------------ 12733
Db 12961 AGGGTAATATCCGGAAACCTCCTCGGATTCCATTGCCCAGCTATCTGTCACTTTATTGTG 13020
Qy 12734 ------------------------------------------------------------ 12733
Db 13021 AAGATAGTGGAAAAGGAAGGTGGCTCCTACAAATGCCATCATTGCGATAAAGGAAAGGCC 13080
Qy 12734 ------------------------------------------------------------ 12733
Db 13081 ATCGTTGAAGATGCCTCTGCCGACAGTGGTCCCAAAGATGGACCCCCACCCACGAGGAGC 13140
Qy 12734 ------------------------------------------------------------ 12733
Db 13141 ATCGTGGAAAAAGAAGACGTTCCAACCACGTCTTCAAAGCAAGTGGATTGATGTGATATC 13200
Qy 12734 ------------------------------------------------------------ 12733
Db 13201 TCCACTGACGTAAGGGATGACGCACAATCCCACTATCCTTCGCAAGACCCTTCCTCTATA 13260
Qy 12734 ------------------------------------------------------------ 12733
Db 13261 TAAGGAAGTTCATTTCATTTGGAGAGGACAGGGTACCCGGGGATCCACCATGTCTCCGGA 13320
Qy 12734 ------------------------------------------------------------ 12733
Db 13321 GAGGAGACCAGTTGAGATTAGGCCAGCTACAGCAGCTGATATGGCCGCGGTTTGTGATAT 13380
Qy 12734 ------------------------------------------------------------ 12733
Db 13381 CGTTAACCATTACATTGAGACGTCTACAGTGAACTTTAGGACAGAGCCACAAACACCACA 13440
Qy 12734 ------------------------------------------------------------ 12733
Db 13441 AGAGTGGATTGATGATCTAGAGAGGTTGCAAGATAGATACCCTTGGTTGGTTGCTGAGGT 13500
Qy 12734 ------------------------------------------------------------ 12733
Db 13501 TGAGGGTGTTGTGGCTGGTATTGCTTACGCTGGGCCCTGGAAGGCTAGGAACGCTTACGA 13560
Qy 12734 ------------------------------------------------------------ 12733
Db 13561 TTGGACAGTTGAGAGTACTGTTTACGTGTCACATAGGCATCAAAGGTTGGGCCTAGGATC 13620
Qy 12734 ------------------------------------------------------------ 12733
Db 13621 CACATTGTACACACATTTGCTTAAGTCTATGGAGGCGCAAGGTTTTAAGTCTGTGGTTGC 13680
Qy 12734 ------------------------------------------------------------ 12733
Db 13681 TGTTATAGGCCTTCCAAACGATCCATCTGTTAGGTTGCATGAGGCTTTGGGATACACAGC 13740
Qy 12734 ------------------------------------------------------------ 12733
Db 13741 CCGGGGTACATTGCGCGCAGCTGGATACAAGCATGGTGGATGGCATGATGTTGGTTTTTG 13800
Qy 12734 ------------------------------------------------------------ 12733
Db 13801 GCAAAGGGATTTTGAGTTGCCAGCTCCTCCAAGGCCAGTTAGGCCAGTTACCCAGATCTG 13860
Qy 12734 ------------------------------------------------------------ 12733
Db 13861 AGTCGACCTGCAGGCATGCCCGCTGAAATCACCAGTCTCTCTCTACAAATCTATCTCTCT 13920
Qy 12734 ------------------------------------------------------------ 12733
Db 13921 CTATAATAATGTGTGAGTAGTTCCCAGATAAGGGAATTAGGGTTCTTATAGGGTTTCGCT 13980
Qy 12734 ------------------------------------------------------------ 12733
Db 13981 CATGTGTTGAGCATATAAGAAACCCTTAGTATGTATTTGTATTTGTAAAATACTTCTATC 14040
Qy 12734 ------------------------------------------------------------ 12733
Db 14041 AATAAAATTTCTAATTCCTAAAACCAAAATCCAGGGCGAGCTCGAATTCGAGCTCGAGCC 14100
Qy 12734 ------------------------------------------------------------ 12733
Db 14101 CGGGTGGATCCTCTAGAGTCGACCTGCAGAAGCTTCGGTCCGGCGCGCCTCTAGTTGAAG 14160
Qy 12734 ------------------------------------------------------------ 12733
Db 14161 ACACGTTCATGTCTTCATCGTAAGAAGACACTCAGTAGTCTTCGGCCAGAATGGCCTAAC 14220
Qy 12734 ------------------------------------------------------------ 12733
Db 14221 TCAAGGCCATCGTGGCCTCTTGCTCTTCAGGATGAAGAGCTATGTTTAAACGTGCAAGCG 14280
Qy 12734 ------------------------------------------------------------ 12733
Db 14281 CTACTAGACAATTCAGTACATTAAAAACGTCCGCAATGTGTTATTAAGTTGTCTAAGCGT 14340
Qy 12734 ------------------------------TAAGAACTTCGATCCGAAATATCGTTTCAA 12763
||||||||||||||||||||||||||||||
Db 14341 CAATTTGGAACAAGTGGCTATCGCCAGATATAAGAACTTCGATCCGAAATATCGTTTCAA 14400
Qy 12764 AACTAGAAAACAGCGCGGCTTTGGCTAAGCCGCGCACTATATAGGATTTTGGGCACCTTT 12823
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 14401 AACTAGAAAACAGCGCGGCTTTGGCTAAGCCGCGCACTATATAGGATTTTGGGCACCTTT 14460
Qy 12824 TGATGGAACGTGAAAGCGTACTGCGCACTAGTTATTTAGGTTGAACCTTGGATATACGGT 12883
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 14461 TGATGGAACGTGAAAGCGTACTGCGCACTAGTTATTTAGGTTGAACCTTGGATATACGGT 14520
Selection of these PAM sites for excision of the selectable marker would thus result in transgenic maize plants comprising the instant SEQ ID NO:25.
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 1-2 and 4-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-4 of U.S. Patent No. 11,753,648.
‘648 claims a biological sample comprising non-intact plant tissue comprising SEQ ID NO:34. SEQ ID NO:34 has 100% identity to bases 12365-13066 of SEQ ID NO:25:
RESULT 2
US-17-680-647-25
Sequence 25, US/17680647
Patent No. 11753648
GENERAL INFORMATION
APPLICANT: Nuccio, Michael
APPLICANT: Kock, Michael
APPLICANT: Price, Joshua L.
TITLE OF INVENTION: INIR6 TRANSGENIC MAIZE
FILE REFERENCE: P13421WO01
CURRENT APPLICATION NUMBER: US/17/680,647
CURRENT FILING DATE: 2022-02-25
PRIOR APPLICATION NUMBER: PCT/US21/43496
PRIOR FILING DATE: 2021-07-28
PRIOR APPLICATION NUMBER: PCT/US21/43207
PRIOR FILING DATE: 2021-07-26
PRIOR APPLICATION NUMBER: PCT/US21/43192
PRIOR FILING DATE: 2021-07-26
PRIOR APPLICATION NUMBER: PCT/US21/43187
PRIOR FILING DATE: 2021-07-26
PRIOR APPLICATION NUMBER: PCT/US21/43170
PRIOR FILING DATE: 2021-07-26
PRIOR APPLICATION NUMBER: PCT/US21/43161
PRIOR FILING DATE: 2021-07-26
PRIOR APPLICATION NUMBER: 63/203,137
PRIOR FILING DATE: 2021-07-09
PRIOR APPLICATION NUMBER: 17/302,121
PRIOR FILING DATE: 2021-04-23
PRIOR APPLICATION NUMBER: 63/201,029
PRIOR FILING DATE: 2021-04-09
PRIOR APPLICATION NUMBER: 17/302,110
PRIOR FILING DATE: 2021-04-23
Remaining Prior Application data removed - See File Wrapper or PALM.
NUMBER OF SEQ ID NOS: 35
SEQ ID NO 25
LENGTH: 15115
TYPE: DNA
ORGANISM: Artificial
FEATURE:
OTHER INFORMATION: synthetic
Query Match 100.0%; Score 702; Length 15115;
Best Local Similarity 100.0%;
Matches 702; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AGAAGTACTACTTCTGAGTCATGAGTCATGAGTCAGTTAACCTAGACTTGTCCATCTTCT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 12365 AGAAGTACTACTTCTGAGTCATGAGTCATGAGTCAGTTAACCTAGACTTGTCCATCTTCT 12424
Qy 61 GGATTGGCCAACTTAATTAATGTATGAAATAAAAGGATGCACACATAGTGACATGCTAAT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 12425 GGATTGGCCAACTTAATTAATGTATGAAATAAAAGGATGCACACATAGTGACATGCTAAT 12484
Qy 121 CACTATAATGTGGGCATCAAAGTTGTGTGTTATGTGTAATTACTAGTTATCTGAATAAAA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 12485 CACTATAATGTGGGCATCAAAGTTGTGTGTTATGTGTAATTACTAGTTATCTGAATAAAA 12544
Qy 181 GAGAAAGAGATCATCCATATTTCTTATCCTAAATGAATGTCACGTGTCTTTATAATTCTT 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 12545 GAGAAAGAGATCATCCATATTTCTTATCCTAAATGAATGTCACGTGTCTTTATAATTCTT 12604
Qy 241 TGATGAACCAGATGCATTTCATTAACCAAATCCATATACATATAAATATTAATCATATAT 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 12605 TGATGAACCAGATGCATTTCATTAACCAAATCCATATACATATAAATATTAATCATATAT 12664
Qy 301 AATTAATATCAATTGGGTTAGCAAAACAAATCTAGTCTAGGTGTGTTTTGCGAATTATCG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 12665 AATTAATATCAATTGGGTTAGCAAAACAAATCTAGTCTAGGTGTGTTTTGCGAATTATCG 12724
Qy 361 ATGGGCCCCTAAGAACTTCGATCCGAAATATCGTTTCAAAACTAGAAAACAGCGCGGCTT 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 12725 ATGGGCCCCTAAGAACTTCGATCCGAAATATCGTTTCAAAACTAGAAAACAGCGCGGCTT 12784
Qy 421 TGGCTAAGCCGCGCACTATATAGGATTTTGGGCACCTTTTGATGGAACGTGAAAGCGTAC 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 12785 TGGCTAAGCCGCGCACTATATAGGATTTTGGGCACCTTTTGATGGAACGTGAAAGCGTAC 12844
Qy 481 TGCGCACTAGTTATTTAGGTTGAACCTTGGATATACGGTTCTCACTGCGCCAATGCAAGG 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 12845 TGCGCACTAGTTATTTAGGTTGAACCTTGGATATACGGTTCTCACTGCGCCAATGCAAGG 12904
Qy 541 CTTGAAACTTGGTTAGTAATACGTACTCCCTCCGTTTCTTTTTATTTGTCGCTGGATAGT 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 12905 CTTGAAACTTGGTTAGTAATACGTACTCCCTCCGTTTCTTTTTATTTGTCGCTGGATAGT 12964
Qy 601 GCAATTTTGCACTATCGAGCGACAAATAAAAAGAAACGGAGGGAGTATATGATTGTCAGA 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 12965 GCAATTTTGCACTATCGAGCGACAAATAAAAAGAAACGGAGGGAGTATATGATTGTCAGA 13024
Qy 661 TGTAGATATGTTTATTTATATATCACATACAGATATATAAAA 702
||||||||||||||||||||||||||||||||||||||||||
Db 13025 TGTAGATATGTTTATTTATATATCACATACAGATATATAAAA 13066
This region spans the deletion at base 12734 of the DP-4114 selectable marker in SEQ ID NO:25 as well as portion of DP-4114 cry35Ab1 gene and 3’ genomic DNA that is in the DP-4114 event. SEQ ID NO:34 thus makes obvious the selectable marker deletion in SEQ ID NO:25 and in maize plants comprising it.
It would have been obvious to one of ordinary skill in the art to self the resulting plants to generate more seed and plants with the truncated event. It also would have been obvious to one of ordinary skill in the art to cross the resulting plants to plants of a different genotype to transfer the truncated event into other maize plants of other genetic backgrounds.
Claims 1-2 and 4-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-26 and 30-31 of copending Application No. 19/402,043. Although the claims at issue are not identical, they are not patentably distinct from each other.
‘043 claims a maize plant cell comprising modified locus comprising a deletion of the PAT selectable marker cassette of the DP-4114 event; the modified locus includes SEQ ID NO:25, which is identical to the instant SEQ ID NO:25 as ‘043 is a continuation of the instant application. The maize plants claimed in ‘043 claims 30-31 thus encompass plants comprising SEQ ID NO:25
It would have been obvious to one of ordinary skill in the art to self the resulting plants to generate more seed and plants with the truncated event. It also would have been obvious to one of ordinary skill in the art to cross the resulting plants to plants of a different genotype to transfer the truncated event into other maize plants of other genetic backgrounds.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
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.
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/Anne Kubelik/Primary Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
/YVONNE L EYLER/Director, Art Unit 1600
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