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 .
Claim Status
Claims 1, 3 and 5-21 are pending.
Claims 8-9 and 11-20 are withdrawn from the examination as being part of non-elected inventions.
The Applicant added a new claim, claim 21, which is entered.
Claims 1, 3, 5-7, 10 and 21 are being examined.
All previous objections and rejections not set forth below are withdrawn in view of claim amendments.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 depends from claim 1. Amended claim 1 recites all the limitations of amended claim 3 which does not further restrict claim 1.
The Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
Claims 1, 3, 5-7, 10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Hain et al. (US 2013/0247253 A1) in view of Nadeem et al. (DNA molecular markers in plant breeding: current status and recent advancements in genomic selection and genome editing, 2018, Biotechnology & Biotechnological Equipment, 32:261–285) and McGrath et al. ((A contiguous de novo genome assembly of sugar beet EL10 (Beta vulgaris L.); bioRxiv 15:29831; published on 09/16/2020)).
Hain et al. teaches ALS inhibitor herbicide tolerant sugar beet (Beta vulgaris) plants comprising an endogenous acetolactate synthase (ALS) gene, wherein the ALS gene encodes an ALS polypeptide comprising an amino acid different from (wild type) tryptophan at a position 569 of the ALS polypeptide (abstract; claim 1) and the amino acid replacing the tryptophan (W) at a position 569 is leucine (L) (page 5, para 0057, last line; claim 2). Hain et al. also describes herbicide tolerant Beta vulgaris plants which are homozygous for the substitution mutation (claim 6) (as recited in instant claim 1) and shows a better agronomical level of ALS inhibitor tolerance (page 7, Para 0088, line 5-7). A homozygous Beta vulgaris plant comprises the same DNA molecule in both the chromosomes (as recited in claim 10) of chromosome 5 comprising the ALS-herbicide tolerant endogenous ALS gene with the specific substitution mutation. Hain et al. also describes hybrid plants comprising the ALS inhibitor herbicide tolerant acetolactate synthase (ALS) gene (page 3, para 0031, line 3-6).
Hain describes the acetolactate synthase (ALS) polypeptide (SEQ ID NO: 4) having more than 95% (100%) sequence identity to instant SEQ ID NO: 16 (as recited in claim 1), as shown below.
RESULT 1
US-13-821-966-4
Sequence 4, US/13821969
Patent No. 10544426
GENERAL INFORMATION
APPLICANT: Bayer CropScience AG
TITLE OF INVENTION: Use of ALS inhibitor herbicides for control of unwanted
vegetation in ALS inhibitor herbicide tolerant Beta vulgaris plants
FILE REFERENCE: BCS 09-1020 / 2923343-034000
CURRENT APPLICATION NUMBER: US/13/821,966
CURRENT FILING DATE: 2013-03-08
PRIOR APPLICATION NUMBER: PCT/EP11/67922
PRIOR FILING DATE: 2011-10-13
PRIOR APPLICATION NUMBER: EP 10187759.5
PRIOR FILING DATE: 2010-10-15
PRIOR APPLICATION NUMBER: US 61/394,469
PRIOR FILING DATE: 2010-10-19
NUMBER OF SEQ ID NOS: 4
SEQ ID NO 4
LENGTH: 665
TYPE: PRT
ORGANISM: Beta vulgaris
LOCATION: (569)..(569)
OTHER INFORMATION: Substitution of a Tryptophan by a Leucine
Best Local Similarity 100.0%; Query Match 100.0%; Score 3413; Length 665;
Matches 665; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MAATFTNPTFSPSSTPLTKTLKSQSSISSTLPFSTPPKTPTPLFHRPLQISSSQSHKSSA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAATFTNPTFSPSSTPLTKTLKSQSSISSTLPFSTPPKTPTPLFHRPLQISSSQSHKSSA 60
Qy 61 IKTQTQAPSSPAIEDSSFVSRFGPDEPRKGSDVLVEALEREGVTNVFAYPGGASMEIHQA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 IKTQTQAPSSPAIEDSSFVSRFGPDEPRKGSDVLVEALEREGVTNVFAYPGGASMEIHQA 120
Qy 121 LTRSKTIRNVLPRHEQGGVFAAEGYARATGKVGVCIATSGPGATNLVSGLADALLDSVPL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LTRSKTIRNVLPRHEQGGVFAAEGYARATGKVGVCIATSGPGATNLVSGLADALLDSVPL 180
Qy 181 VAITGQVPRRMIGTDAFQETPIVEVTRSITKHNYLVLDVEDIPRIVKEAFFLANSGRPGP 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 VAITGQVPRRMIGTDAFQETPIVEVTRSITKHNYLVLDVEDIPRIVKEAFFLANSGRPGP 240
Qy 241 VLIDLPKDIQQQLVVPDWDRPFKLGGYMSRLPKSKFSTNEVGLLEQIVRLMSESKKPVLY 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VLIDLPKDIQQQLVVPDWDRPFKLGGYMSRLPKSKFSTNEVGLLEQIVRLMSESKKPVLY 300
Qy 301 VGGGCLNSSEELRRFVELTGIPVASTLMGLGSYPCNDELSLHMLGMHGTVYANYAVDKAD 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 VGGGCLNSSEELRRFVELTGIPVASTLMGLGSYPCNDELSLHMLGMHGTVYANYAVDKAD 360
Qy 361 LLLAFGVRFDDRVTGKLEAFASRAKIVHIDIDSAEIGKNKQPHVSICADVKLALRGMNKI 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LLLAFGVRFDDRVTGKLEAFASRAKIVHIDIDSAEIGKNKQPHVSICADVKLALRGMNKI 420
Qy 421 LESRIGKLNLDFSKWREELGEQKKEFPLSFKTFGDAIPPQYAIQVLDELTNGNAIISTGV 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 LESRIGKLNLDFSKWREELGEQKKEFPLSFKTFGDAIPPQYAIQVLDELTNGNAIISTGV 480
Qy 481 GQHQMWAAQHYKYRNPRQWLTSGGLGAMGFGLPAAIGAAVARPDAVVVDIDGDGSFIMNV 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 GQHQMWAAQHYKYRNPRQWLTSGGLGAMGFGLPAAIGAAVARPDAVVVDIDGDGSFIMNV 540
Qy 541 QELATIRVENLPVKIMLLNNQHLGMVVQLEDRFYKANRAHTYLGNPSKSADIFPDMLKFA 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 QELATIRVENLPVKIMLLNNQHLGMVVQLEDRFYKANRAHTYLGNPSKSADIFPDMLKFA 600
Qy 601 EACDIPSARVSNVADLRAAIQTMLDTPGPYLLDVIVPHQEHVLPMIPSGAGFKDTITEGD 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 EACDIPSARVSNVADLRAAIQTMLDTPGPYLLDVIVPHQEHVLPMIPSGAGFKDTITEGD 660
Qy 661 GRTSY 665
|||||
Db 661 GRTSY 665
The allele of the ALS gene (gene ID: Bevul.5G155900), encoding the ALS protein, comprises more than 95% (99%) sequence identity to instant SEQ ID NO: 15 and is located in chromosome 5 (as recited in claims 1, 3, 7, and 10) starting at position 46936643 and ending at position 46934646 in the reference sugar beet genome, as shown below.
>jgi:EL10_2_Chr5_782 Bvulgarissspvulgaris|782|EL10.2_2
Length=67929547
Score = 3599 bits (3991), Expect = 0.0
Identities = 1997/1998 (99%), Gaps = 0/1998 (0%)
Strand=Plus/Minus
Query 1 ATGGCGGCTACCTTCACAAACCCAACATTTTCCCCTTCCTCAACTCCATTAACCAAAACC 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46936643 ATGGCGGCTACCTTCACAAACCCAACATTTTCCCCTTCCTCAACTCCATTAACCAAAACC 46936584
Query 61 CTAAAATCCCAATCTTCCATCTCTTCAACCCTCCCCTTTTCCACCCCTCCCAAAACCCCA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46936583 CTAAAATCCCAATCTTCCATCTCTTCAACCCTCCCCTTTTCCACCCCTCCCAAAACCCCA 46936524
Query 121 ACTCCACTCTTTCACCGTCCCCTCCAAATCTCATCCTCCCAATCCCACAAATCATCCGCC 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46936523 ACTCCACTCTTTCACCGTCCCCTCCAAATCTCATCCTCCCAATCCCACAAATCATCCGCC 46936464
Query 181 ATTAAAACACAAACTCAAGCACCTTCTTCTCCAGCTATTGAAGATTCATCTTTCGTTTCT 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46936463 ATTAAAACACAAACTCAAGCACCTTCTTCTCCAGCTATTGAAGATTCATCTTTCGTTTCT 46936404
Query 241 CGATTTGGCCCTGATGAACCCAGAAAAGGGTCCGATGTCCTCGTTGAAGCTCTTGAGCGT 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46936403 CGATTTGGCCCTGATGAACCCAGAAAAGGGTCCGATGTCCTCGTTGAAGCTCTTGAGCGT 46936344
Query 301 GAAGGTGTTACCAATGTGTTTGCTTACCCTGGTGGTGCATCTATGGAAATCCACCAAGCT 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46936343 GAAGGTGTTACCAATGTGTTTGCTTACCCTGGTGGTGCATCTATGGAAATCCACCAAGCT 46936284
Query 361 CTCACACGCTCTAAAACCATCCGCAATGTCCTCCCTCGCCATGAACAAGGCGGGGTTTTC 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46936283 CTCACACGCTCTAAAACCATCCGCAATGTCCTCCCTCGCCATGAACAAGGCGGGGTTTTC 46936224
Query 421 GCCGCCGAGGGATATGCTAGAGCTACTGGAAAGGTTGGTGTCTGCATTGCGACTTCTGGT 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46936223 GCCGCCGAGGGATATGCTAGAGCTACTGGAAAGGTTGGTGTCTGCATTGCGACTTCTGGT 46936164
Query 481 CCTGGTGCTACCAACCTCGTATCAGGTCTTGCTGACGCTCTCCTTGATTCTGTCCCTCTT 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46936163 CCTGGTGCTACCAACCTCGTATCAGGTCTTGCTGACGCTCTCCTTGATTCTGTCCCTCTT 46936104
Query 541 GTTGCCATCACTGGCCAAGTTCCACGCCGTATGATTGGCACTGATGCTTTTCAGGAGACT 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46936103 GTTGCCATCACTGGCCAAGTTCCACGCCGTATGATTGGCACTGATGCTTTTCAGGAGACT 46936044
Query 601 CCAATTGTTGAGGTGACAAGGTCTATTACTAAGCATAATTATTTAGTTTTGGATGTAGAG 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46936043 CCAATTGTTGAGGTGACAAGGTCTATTACTAAGCATAATTATTTAGTTTTGGATGTAGAG 46935984
Query 661 GATATTCCTAGAATTGTTAAGGAAGCCttttttttAGCTAATTCTGGTAGGCCTGGACCT 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935983 GATATTCCTAGAATTGTTAAGGAAGCCTTTTTTTTAGCTAATTCTGGTAGGCCTGGACCT 46935924
Query 721 GTTTTGATTGATCTTCCTAAAGATATTCAGCAGCAATTGGTTGTTCCTGATTGGGATAGG 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935923 GTTTTGATTGATCTTCCTAAAGATATTCAGCAGCAATTGGTTGTTCCTGATTGGGATAGG 46935864
Query 781 CCTTTTAAGTTGGGTGGGTATATGTCTAGGCTGCCAAAGTCCAAGTTTTCGACGAATGAG 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935863 CCTTTTAAGTTGGGTGGGTATATGTCTAGGCTGCCAAAGTCCAAGTTTTCGACGAATGAG 46935804
Query 841 GTTGGACTTCTTGAGCAGATTGTGAGGTTGATGAGTGAGTCGAAGAAGCCTGTCTTGTAT 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935803 GTTGGACTTCTTGAGCAGATTGTGAGGTTGATGAGTGAGTCGAAGAAGCCTGTCTTGTAT 46935744
Query 901 GTGGGAGGTGGGTGTTTGAATTCTAGTGAGGAGTTGAGGAGATTTGTTGAGTTGACAGGG 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935743 GTGGGAGGTGGGTGTTTGAATTCTAGTGAGGAGTTGAGGAGATTTGTTGAGTTGACAGGG 46935684
Query 961 ATTCCGGTGGCTAGTACTTTGATGGGGTTGGGGTCTTACCCTTGTAATGATGAACTGTCT 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935683 ATTCCGGTGGCTAGTACTTTGATGGGGTTGGGGTCTTACCCTTGTAATGATGAACTGTCT 46935624
Query 1021 CTTCATATGTTGGGGATGCACGGGACTGTTTATGCCAATTATGCGGTGGATAAGGCGGAT 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935623 CTTCATATGTTGGGGATGCACGGGACTGTTTATGCCAATTATGCGGTGGATAAGGCGGAT 46935564
Query 1081 TTGTTGCTTGCTTTCGGGGTTAGGTTTGATGATCGTGTGACCGGGAAGCTCGAGGCGTTT 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935563 TTGTTGCTTGCTTTCGGGGTTAGGTTTGATGATCGTGTGACCGGGAAGCTCGAGGCGTTT 46935504
Query 1141 GCTAGCCGTGCTAAGATTGTGCATATTGATATTGACTCTGCTGAGATTGGGAAGAACAAG 1200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935503 GCTAGCCGTGCTAAGATTGTGCATATTGATATTGACTCTGCTGAGATTGGGAAGAACAAG 46935444
Query 1201 CAGCCCCATGTGTCCATTTGTGCTGATGTTAAATTGGCATTGCGGGGTATGAATAAGATT 1260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935443 CAGCCCCATGTGTCCATTTGTGCTGATGTTAAATTGGCATTGCGGGGTATGAATAAGATT 46935384
Query 1261 CTGGAGTCTAGAATAGGGAAGCTGAATTTGGATTTCTCCAAGTGGAGAGAAGAATTAGGT 1320
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935383 CTGGAGTCTAGAATAGGGAAGCTGAATTTGGATTTCTCCAAGTGGAGAGAAGAATTAGGT 46935324
Query 1321 GAGCAGAAGAAGGAATTCCCACTGAGTTTTAAGACATTTGGGGATGCAATTCCTCCACAA 1380
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935323 GAGCAGAAGAAGGAATTCCCACTGAGTTTTAAGACATTTGGGGATGCAATTCCTCCACAA 46935264
Query 1381 TATGCCATTCAGGTGCTTGATGAGTTGACCAATGGTAATGCTATTATAAGTACTGGTGTT 1440
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935263 TATGCCATTCAGGTGCTTGATGAGTTGACCAATGGTAATGCTATTATAAGTACTGGTGTT 46935204
Query 1441 GGGCAGCACCAAATGTGGGCTGCGCAGCATTACAAGTACAGAAACCCTCGCCAATGGCTG 1500
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935203 GGGCAGCACCAAATGTGGGCTGCGCAGCATTACAAGTACAGAAACCCTCGCCAATGGCTG 46935144
Query 1501 ACCTCTGGTGGGTTGGGGGCTATGGGGTTTGGGCTACCAGCCGCCATTGGAGCTGCAGTT 1560
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935143 ACCTCTGGTGGGTTGGGGGCTATGGGGTTTGGGCTACCAGCCGCCATTGGAGCTGCAGTT 46935084
Query 1561 GCTCGACCAGATGCAGTGGTTGTCGATATTGATGGGGATGGCAGTTTTATTATGAATGTT 1620
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935083 GCTCGACCAGATGCAGTGGTTGTCGATATTGATGGGGATGGCAGTTTTATTATGAATGTT 46935024
Query 1621 CAAGAGTTGGCTACAATTAGGGTGGAAAATCTCCCAGTTAAGATAATGCTGCTAAACAAT 1680
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46935023 CAAGAGTTGGCTACAATTAGGGTGGAAAATCTCCCAGTTAAGATAATGCTGCTAAACAAT 46934964
Query 1681 CAACATTTAGGTATGGTTGTCCAATTGGAAGATAGGTTCTATAAAGCTAACCGGGCACAT 1740
||||||||||||||||||||||||| ||||||||||||||||||||||||||||||||||
Sbjct 46934963 CAACATTTAGGTATGGTTGTCCAATGGGAAGATAGGTTCTATAAAGCTAACCGGGCACAT 46934904
Query 1741 ACATACCTTGGAAACCCTTCCAAATCTGCTGATATCTTCCCTGATATGCTCAAATTCGCT 1800
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46934903 ACATACCTTGGAAACCCTTCCAAATCTGCTGATATCTTCCCTGATATGCTCAAATTCGCT 46934844
Query 1801 GAGGCATGTGATATTCCTTCTGCCCGTGTTAGCAACGTGGCTGATTTGAGGGCCGCCATT 1860
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46934843 GAGGCATGTGATATTCCTTCTGCCCGTGTTAGCAACGTGGCTGATTTGAGGGCCGCCATT 46934784
Query 1861 CAAACAATGTTGGATACTCCAGGGCCGTACCTGCTCGATGTGATTGTACCGCATCAAGAG 1920
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46934783 CAAACAATGTTGGATACTCCAGGGCCGTACCTGCTCGATGTGATTGTACCGCATCAAGAG 46934724
Query 1921 CATGTGTTGCCTATGATTCCAAGTGGTGCCGGTTTCAAGGATACCATTACAGAGGGTGAT 1980
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46934723 CATGTGTTGCCTATGATTCCAAGTGGTGCCGGTTTCAAGGATACCATTACAGAGGGTGAT 46934664
Query 1981 GGAAGAACCTCTTATTGA 1998
||||||||||||||||||
Sbjct 46934663 GGAAGAACCTCTTATTGA 46934646
A search using SEQ ID NO: 4, as described by Hain et al., which is having 100% sequence identity to instant SEQ ID NO: 16, identifies an ALS allele (GenBank accession No. XP_010695365) in Beta vulgaris having 99.8% sequence identity with the instant SEQ ID NO: 16 and having only one amino acid mismatch in position 569 where tryptophan was present instead of leucine (data not shown), as described by Hain et al. The allele (GenBank gene ID/symbol: LOC104908017) is located in chromosome 5, as shown below.
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121
596
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Greyscale
Hain et al. also describes depositing the seeds of the mutant beet plants with the NCIMB, Aberdeen, UK, under Number NCIMB 41705 (page 8, para 0115; page 2, para 0023), as recited in instant claim 6.
However, Hain et al. does not describe any of the genetic markers M5, M6 and M12 comprising SEQ ID NOs: 5, 6 and 12, respectively.
Use and development of molecular/genetic markers is a routine and standard practice in the art, as described by Nadeem et al. (abstract), especially once the whole genome is sequenced and published. Nadeem et al. also describes use of such markers in plant breeding using heterosis (page 268, right column, last para) and introgression (page 269, right column, last para), as applied to hybrid plants, and detecting hybrid plants (page 269, left column, para 1, last line).
Before the effective filing date, it would have been obvious to one with ordinary skill in the art and the artisan would have been motivated to develop molecular markers, as described by Nadeem et al., for the ALS-herbicide tolerant ALS allele(s) in a commercially important Beta vulgaris cultivar, as described by Hain et al.
A standard BLAST search using the known Beta vulgaris genomic database (EL10), as described by McGrath et al., identifies sequences having 100% identity to all the three markers, as recited in claims 1, 3, 10 and 21, in chromosome 5 and those markers are linked to the ALS allele in the same chromosome 5 (as discussed above), as shown below.
Beta vulgaris sequence identical to SEQ ID NO: 5 is shown below;
>jgi:EL10_2_Chr5_782 Bvulgarissspvulgaris|782|EL10.2_2
Length=67929547
Score = 111 bits (122), Expect = 1e-23
Identities = 61/61 (100%), Gaps = 0/61 (0%)
Strand=Plus/Plus
Query 1 CCTATTATCAACGTCAATCACCACCAAAGTCATGAAACTTCAAGATTTTCCAGCCTAGTT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 46886778 CCTATTATCAACGTCAATCACCACCAAAGTCATGAAACTTCAAGATTTTCCAGCCTAGTT 46886837
Query 61 G 61
|
Sbjct 46886838 G 46886838
Beta vulgaris sequence identical to SEQ ID NO: 6;
>jgi:EL10_2_Chr5_782 Bvulgarissspvulgaris|782|EL10.2_2
Length=67929547
Score = 111 bits (122), Expect = 1e-23
Identities = 61/61 (100%), Gaps = 0/61 (0%)
Strand=Plus/Minus
Query 1 TATCGGAGGTTTTGTCTTTGCTTGCTGTGGCCGAGGTGAAATGTTTTTCGAAAGATTAAA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 47408424 TATCGGAGGTTTTGTCTTTGCTTGCTGTGGCCGAGGTGAAATGTTTTTCGAAAGATTAAA 47408365
Query 61 T 61
|
Sbjct 47408364 T 47408364
Beta vulgaris sequence identical to SEQ ID NO: 12;
>jgi:EL10_2_Chr5_782 Bvulgarissspvulgaris|782|EL10.2_2
Length=67929547
Score = 109 bits (120), Expect = 4e-23
Identities = 60/60 (100%), Gaps = 0/60 (0%)
Strand=Plus/Plus
Query 1 ACCTTCTCTGTTTCCGTGATACCATTCTGTAATCCATTTGAACTCCCAACGTTAAATGCT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sbjct 47086389 ACCTTCTCTGTTTCCGTGATACCATTCTGTAATCCATTTGAACTCCCAACGTTAAATGCT 47086448
An ordinarily skilled artisan would have been motivated to develop and use molecular markers to identify and/or develop different hybrid Beta vaulgaris plants, which is an economically important plant, by stacking the ALS-herbicide tolerant ALS allele with other commercially important traits in other commercially important sugar beet cultivars. The markers would also have been helpful to develop homozygously present ALS allele in sugar beet plants comprising the same ALS-herbicide tolerant ALS allele in both the chromosomes to get a better agronomical level of ALS herbicide tolerance, as taught by Hain et al. It is an experimental design choice of the Artisan to use any specific markers including instant SEQ ID NOs: 5-6 and 12 without affecting the outcome. Use of any closely linked marker does not change the function(s) of an allele of a gene.
Considering the locations of the ALS allele in relation to the markers (M5, M6 and M12), an ordinarily skilled artisan would acknowledge that the Beta vulgaris plant comprising the ALS gene, as discussed above, is flanked by the marker M5 at one end while M6 and M12 markers flank it at the other end, as recited in claims 1, 3, 10 and 21.
Regarding claim 7; sugar beet plants expression the ALS-herbicide tolerant ALS allele is not expected to affect sugar yield much or in a significant way if at all, because there is no extra metabolic energy/resource used to express the allele compared to the non-herbicide tolerant ALS allele, and the activity of the ALS enzyme is not known to be affected by the SNP(s) in the herbicide tolerant allele(s). It is known in the art that weeds can significantly impact sugar beet’s quality and yield. Weed control in sugar beet cultivation (by any means including using ALS herbicides which ALS herbicide tolerant plants can withstand and grow normally) significantly impact and improve both quality and yield in terms of higher sucrose content, higher purity, improved extractable sugar percentage, enhanced root yield and boost overall sugar yield1.
The data obtained in 2020 from the KWS’ SMART seed varieties like SMART JANNINKA KWS, which contains ALS-herbicide tolerant ALS allele(s), indicates that the yield is more than 90% compared to a non-herbicide tolerant control variety2, which would be reflected in sugar yield from the plants.
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, 3, 5-7, 10 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/687,796 (reference application) in view of Hain et al. and McGrath et al. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the reference application recites a sugar beet plant comprising an ALS enzyme having at least 95% sequence identity with the amino acid sequence of SEQ ID NO:1 and further comprising a leucine at a position corresponding to amino acid position 569 instead of the naturally occurring tryptophan. Instant SEQ ID NO:16 encodes such a protein where the amino acid sequence of SEQ ID NO:1 (in the reference claim) and further comprising a leucine at a position corresponding to amino acid position 569 instead of the naturally occurring tryptophan. Sequence alignment between these two sequences and (grey) highlighting the substitution of tryptophan with leucine at a position corresponding to amino acid position 569, is shown below.
Title: US-18-687-799-16
Perfect score: 3413
Sequence: 1 MAATFTNPTFSPSSTPLTKT..........IPSGAGFKDTITEGDGRTSY 665
Searched: 1 seqs, 660 residues
Database : US-18-687-796-1.pep:*
RESULT 1
US-18-687-796-1
Query Match 99.0%; Score 3380; DB 1; Length 660; Best Local Similarity 99.8%;
Matches 659; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 MAATFTNPTFSPSSTPLTKTLKSQSSISSTLPFSTPPKTPTPLFHRPLQISSSQSHKSSA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAATFTNPTFSPSSTPLTKTLKSQSSISSTLPFSTPPKTPTPLFHRPLQISSSQSHKSSA 60
Qy 61 IKTQTQAPSSPAIEDSSFVSRFGPDEPRKGSDVLVEALEREGVTNVFAYPGGASMEIHQA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 IKTQTQAPSSPAIEDSSFVSRFGPDEPRKGSDVLVEALEREGVTNVFAYPGGASMEIHQA 120
Qy 121 LTRSKTIRNVLPRHEQGGVFAAEGYARATGKVGVCIATSGPGATNLVSGLADALLDSVPL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LTRSKTIRNVLPRHEQGGVFAAEGYARATGKVGVCIATSGPGATNLVSGLADALLDSVPL 180
Qy 181 VAITGQVPRRMIGTDAFQETPIVEVTRSITKHNYLVLDVEDIPRIVKEAFFLANSGRPGP 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 VAITGQVPRRMIGTDAFQETPIVEVTRSITKHNYLVLDVEDIPRIVKEAFFLANSGRPGP 240
Qy 241 VLIDLPKDIQQQLVVPDWDRPFKLGGYMSRLPKSKFSTNEVGLLEQIVRLMSESKKPVLY 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VLIDLPKDIQQQLVVPDWDRPFKLGGYMSRLPKSKFSTNEVGLLEQIVRLMSESKKPVLY 300
Qy 301 VGGGCLNSSEELRRFVELTGIPVASTLMGLGSYPCNDELSLHMLGMHGTVYANYAVDKAD 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 VGGGCLNSSEELRRFVELTGIPVASTLMGLGSYPCNDELSLHMLGMHGTVYANYAVDKAD 360
Qy 361 LLLAFGVRFDDRVTGKLEAFASRAKIVHIDIDSAEIGKNKQPHVSICADVKLALRGMNKI 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LLLAFGVRFDDRVTGKLEAFASRAKIVHIDIDSAEIGKNKQPHVSICADVKLALRGMNKI 420
Qy 421 LESRIGKLNLDFSKWREELGEQKKEFPLSFKTFGDAIPPQYAIQVLDELTNGNAIISTGV 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 LESRIGKLNLDFSKWREELGEQKKEFPLSFKTFGDAIPPQYAIQVLDELTNGNAIISTGV 480
Qy 481 GQHQMWAAQHYKYRNPRQWLTSGGLGAMGFGLPAAIGAAVARPDAVVVDIDGDGSFIMNV 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 GQHQMWAAQHYKYRNPRQWLTSGGLGAMGFGLPAAIGAAVARPDAVVVDIDGDGSFIMNV 540
Qy 541 QELATIRVENLPVKIMLLNNQHLGMVVQLEDRFYKANRAHTYLGNPSKSADIFPDMLKFA 600
|||||||||||||||||||||||||||| |||||||||||||||||||||||||||||||
Db 541 QELATIRVENLPVKIMLLNNQHLGMVVQWEDRFYKANRAHTYLGNPSKSADIFPDMLKFA 600
Qy 601 EACDIPSARVSNVADLRAAIQTMLDTPGPYLLDVIVPHQEHVLPMIPSGAGFKDTITEGD 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 EACDIPSARVSNVADLRAAIQTMLDTPGPYLLDVIVPHQEHVLPMIPSGAGFKDTITEGD 660
However, claim 1 in the reference application does not recite a hybrid plant or the M5, M6 and M12 markers.
Hain et al. describes an ALS gene in chromosome 5, as discussed above. Hain et al. also describes hybrid plants comprising the ALS inhibitor herbicide tolerant acetolactate synthase (ALS) gene (column 5, line 32-36).
Considering the locations of the ALS allele in relation to the markers (M5, M6 and M12), an ordinarily skilled artisan would acknowledge that it is an inherent property of a Beta vulgaris plant to have an ALS gene flanked by the marker M5 at one end and M6 and M12 markers at the other end, as discussed above.
It would have been obvious to an ordinarily skilled artisan to develop hybrid plants (as described by Hain et al. by crossing the sugar beet plant comprising the ALS inhibitor herbicide tolerant acetolactate synthase (ALS) allele, as recited in reference claim 1, with an elite sugar beet variety that does not have the ALS allele and, thus, does not the herbicide tolerant trait.
An ordinarily skilled artisan would have been motivated to stack different traits in a commercially important elite sugar beet variety along with the ALS inhibitor herbicide tolerance trait conferred by the ALS inhibitor herbicide tolerant acetolactate synthase (ALS) gene.
Hain et al. also teaches all the claim limitations of claims 1, 3, 5-7, 10 and 21 in view of McGrath et al., as discussed above. Development of hybrid plants, use and development of molecular/genetic markers in plant breeding is a routine and standard practice in the art, especially once the whole genome is sequenced and published. McGrath et al. (in its entirety) describes Beta vulgaris genomic sequence database.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5-7, 10 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 10865406 B2 (hereafter referred as ‘406B) in view of Hain et al. and McGrath et al.
Claim 1 of ‘406B is drawn to a method of producing an ALS inhibitor herbicide tolerant Beta vulgaris plant or parts thereof. Reference claim 1 recites, “… wherein the plantlets comprise a mutation at a position corresponding to nucleotides 1705-1707 of the endogenous
acetolactate synthase (ALS) gene shown in reference sequence SEQ ID NO: 1, wherein the mutated ALS gene encodes an ALS polypeptide containing leucine at position 569 of the ALS polypeptide shown in reference amino acid sequence SEQ ID NO: 2, and wherein the plantlets are homozygous for the mutation of the endogenous ALS gene.”
Instant SEQ ID NO: 16 encodes such a protein where the amino acid sequence of SEQ ID NO. 2 comprises 99.8% sequence identity, as shown below.
RESULT 1
AASEQ2_03032026_173410
Query Match 99.8%; Score 3407; DB 1; Length 665; Best Local Similarity 99.8%;
Matches 664; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 MAATFTNPTFSPSSTPLTKTLKSQSSISSTLPFSTPPKTPTPLFHRPLQISSSQSHKSSA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAATFTNPTFSPSSTPLTKTLKSQSSISSTLPFSTPPKTPTPLFHRPLQISSSQSHKSSA 60
Qy 61 IKTQTQAPSSPAIEDSSFVSRFGPDEPRKGSDVLVEALEREGVTNVFAYPGGASMEIHQA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 IKTQTQAPSSPAIEDSSFVSRFGPDEPRKGSDVLVEALEREGVTNVFAYPGGASMEIHQA 120
Qy 121 LTRSKTIRNVLPRHEQGGVFAAEGYARATGKVGVCIATSGPGATNLVSGLADALLDSVPL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LTRSKTIRNVLPRHEQGGVFAAEGYARATGKVGVCIATSGPGATNLVSGLADALLDSVPL 180
Qy 181 VAITGQVPRRMIGTDAFQETPIVEVTRSITKHNYLVLDVEDIPRIVKEAFFLANSGRPGP 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 VAITGQVPRRMIGTDAFQETPIVEVTRSITKHNYLVLDVEDIPRIVKEAFFLANSGRPGP 240
Qy 241 VLIDLPKDIQQQLVVPDWDRPFKLGGYMSRLPKSKFSTNEVGLLEQIVRLMSESKKPVLY 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VLIDLPKDIQQQLVVPDWDRPFKLGGYMSRLPKSKFSTNEVGLLEQIVRLMSESKKPVLY 300
Qy 301 VGGGCLNSSEELRRFVELTGIPVASTLMGLGSYPCNDELSLHMLGMHGTVYANYAVDKAD 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 VGGGCLNSSEELRRFVELTGIPVASTLMGLGSYPCNDELSLHMLGMHGTVYANYAVDKAD 360
Qy 361 LLLAFGVRFDDRVTGKLEAFASRAKIVHIDIDSAEIGKNKQPHVSICADVKLALRGMNKI 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LLLAFGVRFDDRVTGKLEAFASRAKIVHIDIDSAEIGKNKQPHVSICADVKLALRGMNKI 420
Qy 421 LESRIGKLNLDFSKWREELGEQKKEFPLSFKTFGDAIPPQYAIQVLDELTNGNAIISTGV 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 LESRIGKLNLDFSKWREELGEQKKEFPLSFKTFGDAIPPQYAIQVLDELTNGNAIISTGV 480
Qy 481 GQHQMWAAQHYKYRNPRQWLTSGGLGAMGFGLPAAIGAAVARPDAVVVDIDGDGSFIMNV 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 GQHQMWAAQHYKYRNPRQWLTSGGLGAMGFGLPAAIGAAVARPDAVVVDIDGDGSFIMNV 540
Qy 541 QELATIRVENLPVKIMLLNNQHLGMVVQLEDRFYKANRAHTYLGNPSKSADIFPDMLKFA 600
|||||||||||||||||||||||||||| |||||||||||||||||||||||||||||||
Db 541 QELATIRVENLPVKIMLLNNQHLGMVVQWEDRFYKANRAHTYLGNPSKSADIFPDMLKFA 600
Qy 601 EACDIPSARVSNVADLRAAIQTMLDTPGPYLLDVIVPHQEHVLPMIPSGAGFKDTITEGD 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 EACDIPSARVSNVADLRAAIQTMLDTPGPYLLDVIVPHQEHVLPMIPSGAGFKDTITEGD 660
Qy 661 GRTSY 665
|||||
Db 661 GRTSY 665
Sequence alignment between these two sequences and (grey) highlighting the substitution of tryptophan with leucine at a position corresponding to amino acid position 569.
Considering the locations of the ALS allele in relation to the markers (M5, M6 and M12), an ordinarily skilled artisan would acknowledge that it is an inherent property of a Beta vulgaris plant comprising an ALS gene flanked by the marker M5 at one end and M6 and M12 markers at the other end, as discussed above.
It would have been obvious to an ordinarily skilled artisan to modify the teaching as recited in reference claim 1 to make hybrid sugar beet plants using the ALS inhibitor herbicide tolerant Beta vulgaris plant as one of the parents and crossing that with an elite Beta vulgaris cultivar.
Development of hybrid plants, use and development of molecular/ genetic markers in plant breeding is a routine and standard practice in the art, especially once the whole genome is sequenced and published, as described above.
A standard BLAST search using the known Beta vulgaris genomic database, as described by McGrath et al., identifies the ALS herbicide tolerant gene and all the three markers, as recited in claims 1, 3, 10 and 21 (SEQ ID NOs: 5-6 and 12) are in chromosome 5 and those markers are closely linked, as discussed above.
The ordinarily skilled artisan would have been motivated to develop and use molecular markers to identify and/or develop different hybrid Beta vaulgaris plants, which is an economically important plant, by stacking the ALS-herbicide tolerant ALS allele with other commercially important traits in other sugar beet varieties. The markers would also have been helpful to develop homozygously present ALS allele in sugar beet plants comprising the same ALS-herbicide tolerant ALS allele in both the chromosomes to get a better agronomical level of ALS herbicide tolerance, as taught by Hain et al., as discussed above. It is an experimental design choice for the artisan to use any specific markers including instant SEQ ID NOs: 5-6 and 12 without affecting the outcome.
Regarding claim 6, Hain et al. describes a Beta vulgaris plant comprises a mutation in codon 1705-1707 of an endogenous ALS gene encoding an ALS protein containing a leucine at position 569 (claims 1 and 5). The seeds of the sugar beet plant have been deposited as NCIMB 41705.
Regarding claim 7; sugar beet plants expression the ALS-herbicide tolerant ALS allele is not expected to affect sugar yield much or in a significant way if at all, because there is no extra metabolic energy/resource used to express the allele compared to the non-herbicide tolerant ALS allele, and the activity of the ALS enzyme is not known to be affected by the SNP(s) in the herbicide tolerant allele(s). It is known in the art that weeds can significantly impact sugar beet’s quality and yield. Weed control in sugar beet cultivation (by any means including using ALS herbicides which ALS herbicide tolerant plants can withstand and grow normally) significantly impact and improve both quality and yield in terms of higher sucrose content, higher purity, improved extractable sugar percentage, enhanced root yield and boost overall sugar yield. The data obtained in 2020 from the KWS’ SMART seed varieties like SMART JANNINKA KWS, which contains ALS-herbicide tolerant ALS allele(s), indicates that the yield is more than 90% compared to a non-herbicide tolerant control variety, which would be reflected in sugar yield from the plants.
Regarding claim 10; claim 1 of the reference patent anticipates claim 10. Instant claim 10 encompasses the plant produced by the patented method.
Claims 1, 3, 5-7, 10 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 19 of U.S. Patent No. US 10,544,426 B2 (hereafter referred as ‘426B) in view of Hain et al. and McGrath et al.
Claim 1 of ‘426B is drawn to a method for controlling unwanted vegetation in a Beta
vulgaris growing area. Claim 1 or ‘426B recites a “… B. vulgaris plant has a mutation in the endogenous acetolactate synthase (ALS) gene of SEQ ID NO: 1, thereby encoding an ALS protein containing leucine at position 569 of SEQ ID NO:2, and wherein this mutation is the only mutation in the ALS protein that confers resistance to the one or more ALS inhibitor herbicides…”. Claim 19 of ‘426 B recites, “… the mutation is homozygously present in the endogenous ALS gene”.
Instant SEQ ID NO: 16 encodes such a protein where the amino acid sequence of SEQ ID NO. 2 comprises 99.8% sequence identity, data not shown.
It would have been obvious to an ordinarily skilled artisan to modify the teaching as recited in reference claim 1 to make hybrid sugar beet plants using the ALS inhibitor herbicide tolerant Beta vulgaris plant as one of the parents and crossing that with an elite Beta vulgaris cultivar.
Development of hybrid plants, use and development of molecular/genetic markers in plant breeding is a routine and standard practice in the art, especially once the whole genome is sequenced and published, as described above.
A standard BLAST search using the known Beta vulgaris genomic database, as described by McGrath et al., identifies the ALS herbicide tolerant gene and all the three markers (SEQ ID NOs: 5-6 and 12), as recited in claims 1, 3, 10 and 21, are in chromosome 5 and those markers are closely linked, as discussed above.
Considering the location of the ALS allele in relation to the markers (M5, M6 and M12), an ordinarily skilled artisan would acknowledge that it is an inherent property of a Beta vulgaris plant comprising an ALS gene flanked by the marker M5 at one end and M6 and M12 markers at the other end, as discussed above.
The ordinarily skilled artisan would have been motivated to develop and use molecular markers to identify and/or develop different hybrid Beta vaulgaris plants, which is an economically important plant, by stacking the ALS-herbicide tolerant ALS allele with other commercially important traits in other sugar beet varieties. The markers would have been also helpful to develop homozygously present ALS allele in sugar beet plants comprising the same ALS-herbicide tolerant ALS allele in both the chromosomes to get a better agronomical level of ALS herbicide tolerance, as taught by Hain et al., as discussed above. It is an experimental design choice for the artisan to use any specific markers including instant SEQ ID NOs: 5-6 and 12 without affecting the outcome.
Regarding claim 6, Hain et al. describes a Beta vulgaris plant comprises a leucine at position 569 (reference claim 1). The seeds of the sugar beet plant have been deposited as NCIMB 41705.
Regarding claim 7; sugar beet plants expression the ALS-herbicide tolerant ALS allele is not expected to affect sugar yield much or in a significant way if at all, because there is no extra metabolic energy/resource used to express the allele compared to the non-herbicide tolerant ALS allele, and the activity of the ALS enzyme is not known to be affected by the SNP(s) in the herbicide tolerant allele(s). It is known in the art that weeds can significantly impact sugar beet’s quality and yield. Weed control in sugar beet cultivation (by any means including using ALS herbicides which ALS herbicide tolerant plants can withstand and grow normally) significantly impact and improve both quality and yield in terms of higher sucrose content, higher purity, improved extractable sugar percentage, enhanced root yield and boost overall sugar yield. The data obtained in 2020 from the KWS’ SMART seed varieties like SMART JANNINKA KWS, which contains ALS-herbicide tolerant ALS allele(s), indicates that the yield is more than 90% compared to a non-herbicide tolerant control variety, which would be reflected in sugar yield from the plants.
Regarding claim 10, claim 1 of the reference patent anticipates claim 10. Instant claim 10 encompasses the plant that is used in the method of claim 1 of ‘426B.
Response to Applicant’s Arguments
Applicant’s arguments dated 8/10/2026 regarding claim rejections are fully considered but not found persuasive.
Regarding 35 USC 103 rejections, the Applicant argues, “… amended claim 1 now incorporates the marker limitations from previous claim 2 (M5/M6 in one parent; M5/M12 in the other parent). Neither Hain nor Nadeem discloses or suggests that shortening the introgressed fragment would increase sugar yield” (response, p.26, para 2, line 1-4) and then “…. neither from the teaching of Hain, Nadeem, or McGrath alone, nor from any combination thereof, would a person of ordinary skill in the art have arrived at the claimed invention with a reasonable expectation of success” (response, p.29, para 2, line 1-3).
The Examiner disagrees. Claims 2 and 4 are now cancelled by the Applicant. Claim 3 is amended in a way that does not further restrict the base claim 1. Neither amended claim 1 nor amended claim 3 recite (an increase in) “sugar yield” or “shortening the introgressed fragment”, as argued by the Applicant (response, p.26, para 2, line 2-4). The claims require M5, M6 and M12 markers to be present. However, the claims do not exclude other flanking sequences or markers. The Applicant’s argument pertains to limitations that are not present in the claims.
Regarding Double Patenting rejections: All the arguments against double patenting rejections boil down to the amendments in the relevant claims by adding “specific flanking markers (M5/M6 in one parent; M5/M12 in the other parent)” (response, p.29, last para, line 3-4).
The Examiner disagrees. Considering the location of the ALS allele in relation to the markers (M5, M6 and M12), an ordinarily skilled artisan would acknowledge that it is an inherent property of a Beta vulgaris plant to have an ALS gene flanked by the marker M5 at one end and M6 and M12 markers at the other end, as discussed above.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). The 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.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
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Jay Chatterjee
Patent Examiner
Art Unit 1662
/Jay Chatterjee/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
1 Hamed et al. (Enhancing Sugar Beet (Beta vulgaris L.) Yield and Quality: Evaluating the Efficiency of Chemical and Mechanical Weed Control Strategies, 2023, Agronomy, 13:2951) provides the evidence that weed control in sugar beet cultivation significantly impact and improve both quality and yield in terms of higher sucrose content, higher purity, improved extractable sugar percentage, enhanced root yield and boost overall sugar yield (page 2, para 5, line 9-14).
2 KWS UK Ltd. (Revolutionary weed control – five years on, published on 7th March 2025) provides the evidence that sugar beet variety containing an ALS-herbicide tolerant ALS allele gives an yield (in 2020) more than 90% compared to a non-herbicide tolerant control variety.
Prosecution Insights