DETAILED ACTION
Status of the Application
1. The present application is being examined under the pre-AIA first to invent provisions.
2. Claims 1, 2, 5, 8-13, 15-16, 18-21, 23, 25-28 are pending.
3. Claim 25 remains withdrawn from consideration.
4. Claims 1, 2, 5, 8-13, 15-16, 18-21, 23, and 26-28 are examined.
5. The objection to claim 1 is withdrawn in view of Applicant’s amendments to the claim.
Election/Restrictions
6. Previously added claim 25 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the claim is directed to a method that encompass the use of herbicides not previously recited or examined. Since Applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 25 was withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Claim Rejections - 35 USC § 112 - Indefiniteness
7. 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.
8. Claims 1, 2, 5, 8-13, 15-16, 18-21, 23, and 26-28 remain 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.
This rejection has been modified in view of Applicant’s amendments to the claims. Applicant’s argument submitted on March 23, 2026 has been fully considered but it is not persuasive.
In claim 1, as instantly amended, the recitations “polynucleotide … either (i) present in line GM40 or GM1606, a representative sample of seed of each line having been deposited under ATCC Patent Deposit Number PTA-6716 and PTA-7606, respectively, or (ii) is a copy derived from (i)” and “an injury level 0.8/9 or less from said rate of imazapyr” render the claim indefinite. First, it is unclear what is meant by “a copy derived from (i)” - it is unclear whether the word “copy” refers to a polynucleotide and if it does, it is unclear how said “copy” would differ from the polynucleotide recited in the clause preceding part (i). Second, it is unclear “injury level of 0.8/9” means.
On page 6 of the Remarks, in the section directed to the Claim Interpretation, Applicant refers to Example 5 and Table 3. Example 5 does state that “Injury was rated on a scale from 0 to 9 where 0 = no injury to 9 = dead plant.” However, there is no further explanation as to how one of skill in the art could use said subjective estimate of injury in the context of the claimed invention. For example, it is unclear as to what type of injury may be included, the timing after treatment, or how that injury is actually evaluated. The metes and bounds are thus unclear.
Applicant argues that the amendments to claim 1 overcome the rejection (page 6 of the Remarks). This is not found to be persuasive. The amendments are acknowledged and the rejection has been modified accordingly. However, the amended claims remain rejected as set forth in the rejection above.
Claim Interpretation
9. The following is noted with regard to claim interpretation. Claim 1 recites a sunflower crop plant that comprises the phenotype tolerance to at least 160 g ai/ha of imazapyr, wherein the plant “would exhibit an injury level of 0.8/9 or less from said rate.” It is noted that the rate of imazapyr is recited as a property and not an active method step. As set forth above, it is unclear how one would be able to determine what is encompassed by the term “0.8/9.” Moreover, the claim does not specify at what point after treatment the injury level is estimated. The limitation is thus reasonably interpreted as encompassing the scenario of no detectable injury to the plant, relative to a control plant. It is also noted that the instant specification that sunflower plant comprising the A122T substitution are capable to tolerance to imazamox and imazapyr at the injury level indicated as “0.8” in Table 3.
With regard to the phrase “wherein the sunflower AHASL polynucleotide contains no sire-directed mutation,” it is read as a product-by-process limitation that does not affect the structure, and therefore the patentability, of the polynucleotide. It is noted that the structure of a polynucleotide is determined by its nucleotide sequence and not its method of making. See MPEP 2113.
Claim 10 does not require sunflower plants of line GM40 or GM1606, but encompasses any progeny of said plants, of any filial generation. The specificaiton teaches that sunflower plants designated GM40 and GM1606 comprise a threonine at position 107 of the full-length sunflower AHASL protein (see pg. 6). The specificaiton teaches that SEQ ID NO: 2 is a partial amino acid sequence of the herbicide resistant AHASL1 (See Sequence Listing on pg. 12). Thus, the only herbicide tolerance characteristic of the plants of lines GM40 and GM1606 described in the specificaiton is the presence of the A107T substitution (A122T in Arabidopsis numbering) in AHASL. As a result, claim 10 is given its broadest reasonable interpretation as encompassing a sunflower plant with resistance characteristics conferred by the A107T substitution. It is also noted that one of ordinary skill in the art would recognize that the IUPAC names recited in claim 13 encompass imidazolinone herbicides of claim 12; for example, imazethapyr and imazapic.
Applicant argues that the claim interpretation is not applicable to the amended claims (page 6 of the Remarks). This is not found to be persuasive. The claim interpretation was modified to reflect Applicant’s amendments to the claims. The above interpretation applies to the claims as amended.
Claim Rejections - 35 USC § 103
10. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
11. Claims 1, 2, 5, 8-13, 18, 19, 20, and 26-28 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jander et al (US Application No. 2003/0097692 A1, published May 22, 2003), in view of Kolkman et al (Theor. and Appl. Genet. (2004) 109:1147-1159) and Kmiec et al (U.S. Patent Application No. 2003/0236208 A1, published December 25, 2003). Applicant’s argument submitted on March 2, 2026 has been fully considered but it is not persuasive.
The claims are drawn to a method for treating a sunflower plant comprising applying, post-emergence, an effective amount of at least one AHAS-inhibiting herbicide to a sunflower crop plant, wherein the at least one AHAS-inhibiting herbicide comprises imazapyr and the effective amount is at least 40 g ai/ha of imazapyr; wherein the plant comprises the A107T substitution relative to SEQ ID NO: 2; and including wherein the plant is a progeny of line GM40 or GM1606.
Jander et al teach a nucleic acid molecule encoding functional AHAS that has the A122T (A107T in sunflower) substitution; and an imidazolinone-resistant sunflower plant comprising that nucleic acid (claims 1, 2, 7 and 8). Jander et al teach obtaining non-transgenic plants with imidazolinone resistance using EMS mutagenesis (Example 1, beginning at paragraph 71; Example 2, beginning at paragraph 78). Jander et al teach that imidazolinones, such as imazapyr, could be used alone or in combination with other herbicides for post-emergence control of weeds growing with resistant sunflower; and that a variety of imidazolinone herbicides could be used to protect resistant sunflower plants from weeds (pg. 7, paragraph 68; pg. 2, paragraph 0026 ). Jander et al teach determining the I100 value for mutagenized Arabidopsis plants, which was 0.035 lb ai/ha imazethapyr, and teach applying 2x that concentration, 0.07 lb ai/ha, in a sprayable solution, to the seedlings to screen them (paragraph 0075 on pg. 7). Jander et al teach sequencing the ALS genes of the imidazolinone resistant plants and identifying the A122T substitution as one of the mutations that conferred said resistance (paragraph 0099 on pg. 8). Jander et al teach applying imazapyr at 0.07 lb ai/acre and teach that plants expressing said mutant ALS were resistant to said application rate (Example 4, col. 104). One of skill in the art would recognize that the rate of 0.07 lb ai/acre is equivalent to 78 g ai/hectare.
Jander et al do not expressly teach a sunflower plant comprising the A122T or another resistance-conferring substitution in the AHASL.
Kolkman et al teach a sunflower plant comprising at least one copy of an AHASL polynucleotide encoding an herbicide resistant AHASL protein (Fig. 2 on pg. 1152). Kolkman et al teach that A122, P197, and A205 are highly conserved amino acids, whose mutation confers tolerance to AHAS-inhibiting herbicides. Kolkman et al teach applying imazamox, including at 33.2 g ai/ha to 100 g ai/ha to plants tolerant to imidazolinones (pg. 1151 left col.). Kolkman et al also teach substitutions that include A205V and P197L, that confer cross-tolerance to sulfonylureas, including chlorimuron (see pg. 1153, paragraph spanning left and right col., Table 2). Kolkman et al teach that in sunflower, the A205V substitution confers the level of tolerance to imidazolinones that is up to 10x that of susceptible plants (pg. 1157, left col.).
Kolkman et al teach an amino acid sequence that is 99.8% identical to the instant SEQ ID NO: 2. The instant specification defines SEQ ID NO: 2 as truncated sunflower AHASL with an A107T mutation (see pg. 12, lines 25-27; and pg. 65, lines 8-14; identifying position 7 in SEQ ID NO: 2 as corresponding to position 107 in full-length sunflower AHASL). The sequence of Kolkman et al differs from the instant SEQ ID NO: 2 at a single amino acid residue: the sequence of Kolkman et al has an alanine at position 107. The sequence alignment is set forth below:
RA Kolkman J.M., Slabaugh M.B., Bruniard J.M., Berry S., Bushman B.S.,
RA Olungu C., Maes N., Abratti G., Zambelli A., Miller J.F., Leon A.,
RA Knapp S.J.;
RT "Acetohydroxyacid synthase mutations conferring resistance to
RT imidazolinone or sulfonylurea herbicides in sunflower.";
RL Theor. Appl. Genet. 109:1147-1159(2004).
DR EMBL; AY541451; AAT07322.1; -; Genomic_DNA.
SQ SEQUENCE 655 AA; 71322 MW; 3AF7DF2D81C31752 CRC64;
Query Match 99.8%; Score 2026; DB 11; Length 655;
Best Local Similarity 99.7%;
Matches 391; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 FAYPGGTSMEIHQALTRSSTIRNVLPRHEQGGVFAAEGYARASGLPGVCIATSGPGATNL 60
|||||| |||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 101 FAYPGGASMEIHQALTRSSTIRNVLPRHEQGGVFAAEGYARASGLPGVCIATSGPGATNL 160
Qy 61 VSGLADALLDSVPMVAITGQVPRRMIGTDAFQETPIVEVTRSITKHNYLVLDVEDIPRIV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 161 VSGLADALLDSVPMVAITGQVPRRMIGTDAFQETPIVEVTRSITKHNYLVLDVEDIPRIV 220
Qy 121 REAFYLASSGRPGPVLIDVPKDIQQQLVVPKWDEPMRLPGYLSRMPKPQYDGHLEQIVRL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 221 REAFYLASSGRPGPVLIDVPKDIQQQLVVPKWDEPMRLPGYLSRMPKPQYDGHLEQIVRL 280
Qy 181 VGEAKRPVLYVGGGCLNSDDELRRFVELTGIPVASTLMGLGAYPASSDLSLHMLGMHGTV 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 281 VGEAKRPVLYVGGGCLNSDDELRRFVELTGIPVASTLMGLGAYPASSDLSLHMLGMHGTV 340
Qy 241 YANYAVDKSDLLLAFGVRFDDRVTGKLEAFASRAKIVHIDIDPAEIGKNKQPHVSICGDI 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 341 YANYAVDKSDLLLAFGVRFDDRVTGKLEAFASRAKIVHIDIDPAEIGKNKQPHVSICGDI 400
Qy 301 KVALQGLNKILEEKNSVTNLDFSTWRKELDEQKMKFPLSFKTFGEAIPPQYAIQVLDELT 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 401 KVALQGLNKILEEKNSVTNLDFSTWRKELDEQKMKFPLSFKTFGEAIPPQYAIQVLDELT 460
Qy 361 GGNAIISTGVGQHQMWAAQFYKYNKPRQWLTS 392
||||||||||||||||||||||||||||||||
Db 461 GGNAIISTGVGQHQMWAAQFYKYNKPRQWLTS 492
As one skilled in the art would recognize, the amino acid sequence of Kolkman et al corresponds to the non-mutated form of the instant SEQ ID NO: 2.
In addition, Kolkman et al teach a nucleic acid sequence encoding said amino acid sequence and having 99.9% sequence identity to the instant SEQ ID NO: 1. As one skilled in the art would recognize, the nucleic acid sequence of Kolkman et al corresponds to the non-mutated form of the instant SEQ ID NO: 1. The sequence alignment is set forth below.
ORGANISM Helianthus annuus
AUTHORS Kolkman,J.M., Slabaugh,M.B., Bruniard,J.M., Berry,S., Bushman,B.S.,
Olungu,C., Maes,N., Abratti,G., Zambelli,A., Miller,J.F., Leon,A.
and Knapp,S.J.
TITLE Acetohydroxyacid synthase mutations conferring resistance to
imidazolinone or sulfonylurea herbicides in sunflower
JOURNAL Theor. Appl. Genet. 109 (6), 1147-1159 (2004)
PUBMED 15309298
REFERENCE 2 (bases 1 to 1968)
AUTHORS Kolkman,J.M., Slabaugh,M.B., Bruniard,J.M., Berry,S., Bushman,S.,
Olungu,C., Maes,N., Abratti,G., Zambelli,A., Miller,J.F., Leon,A.
and Knapp,S.J.
TITLE Direct Submission
JOURNAL Submitted (04-FEB-2004) Crop and Soil Science, Oregon State
University, Crop Science Building, Corvallis, OR 97331, USA
FEATURES Location/Qualifiers
source 1..1968
/organism="Helianthus annuus"
/mol_type="genomic DNA"
/cultivar="HA 89"
/db_xref="taxon:4232"
/chromosome="9"
/haplotype="1"
gene <1..>1968
/gene="AHAS1"
mRNA <1..>1968
/gene="AHAS1"
/product="acetohydroxyacid synthase 1"
CDS 1..1968
/gene="AHAS1"
/EC_number="2.2.1.6"
/codon_start=1
/product="acetohydroxyacid synthase 1"
/protein_id="AAT07322.1"
/translation="MAAPPNPSISFKPPSPAAALPPRSAFLPRFALPITSTTQKRHRL
HISNVLSDSKSTTTTTTTTQRPLPVQPFVSRYAPDQPRKGADVLVEALEREGVTDVFA
YPGGASMEIHQALTRSSTIRNVLPRHEQGGVFAAEGYARASGLPGVCIATSGPGATNL
VSGLADALLDSVPMVAITGQVPRRMIGTDAFQETPIVEVTRSITKHNYLVLDVEDIPR
IVREAFYLASSGRPGPVLIDVPKDIQQQLVVPKWDEPMRLPGYLSRMPKPQYDGHLEQ
IVRLVGEAKRPVLYVGGGCLNSDDELRRFVELTGIPVASTLMGLGAYPASSDLSLHML
GMHGTVYANYAVDKSDLLLAFGVRFDDRVTGKLEAFASRAKIVHIDIDPAEIGKNKQP
HVSICGDIKVALQGLNKILEEKNSVTNLDFSTWRKELDEQKMKFPLSFKTFGEAIPPQ
YAIQVLDELTGGNAIISTGVGQHQMWAAQFYKYNKPRQWLTSGGLGAMGFGLPAAIGA
AVARPDAVVVDIDGDGSFMMNVQELATIRVENLPVKILLLNNQHLGMVVQWEDRFYKA
NRAHTYLGNPSKESEIFPNMVKFAEACDIPAARVTQKADLRAAIQKMLDTPGPYLLDV
IVPHQEHVLPMIPAGGGFSDVITEGDGRTKY"
Query Match 99.9%; Score 1176.4; DB 129; Length 1968;
Best Local Similarity 99.9%;
Matches 1177; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 TCTTCGCCTACCCCGGCGGCACGTCAATGGAGATCCACCAAGCTCTCACGCGCTCAAGCA 60
|||||||||||||||||||| |||||||||||||||||||||||||||||||||||||||
Db 299 TCTTCGCCTACCCCGGCGGCGCGTCAATGGAGATCCACCAAGCTCTCACGCGCTCAAGCA 358
Qy 61 CTATCCGCAATGTGCTCCCCCGTCACGAACAGGGCGGCGTGTTCGCCGCCGAAGGCTACG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 359 CTATCCGCAATGTGCTCCCCCGTCACGAACAGGGCGGCGTGTTCGCCGCCGAAGGCTACG 418
Qy 121 CGCGCGCCTCCGGTCTTCCCGGCGTGTGTATCGCCACTTCCGGTCCCGGAGCTACGAACC 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 419 CGCGCGCCTCCGGTCTTCCCGGCGTGTGTATCGCCACTTCCGGTCCCGGAGCTACGAACC 478
Qy 181 TAGTTAGTGGTCTTGCTGACGCGCTGTTAGACAGTGTCCCCATGGTGGCAATCACCGGTC 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 479 TAGTTAGTGGTCTTGCTGACGCGCTGTTAGACAGTGTCCCCATGGTGGCAATCACCGGTC 538
Qy 241 AAGTTCCCCGGAGAATGATCGGAACCGATGCGTTTCAAGAAACCCCAATTGTTGAGGTAA 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 539 AAGTTCCCCGGAGAATGATCGGAACCGATGCGTTTCAAGAAACCCCAATTGTTGAGGTAA 598
Qy 301 CACGTTCGATCACTAAACATAATTATCTTGTGTTGGATGTTGAGGATATTCCCAGAATTG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 599 CACGTTCGATCACTAAACATAATTATCTTGTGTTGGATGTTGAGGATATTCCCAGAATTG 658
Qy 361 TTCGTGAGGCTTTTTATCTTGCGAGTTCGGGTCGACCCGGCCCGGTTTTGATAGATGTAC 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 659 TTCGTGAGGCTTTTTATCTTGCGAGTTCGGGTCGACCCGGCCCGGTTTTGATAGATGTAC 718
Qy 421 CGAAAGATATACAGCAACAGTTAGTGGTGCCGAAATGGGATGAACCGATGAGGTTACCGG 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 719 CGAAAGATATACAGCAACAGTTAGTGGTGCCGAAATGGGATGAACCGATGAGGTTACCGG 778
Qy 481 GTTATTTGTCTAGAATGCCGAAGCCTCAATATGATGGGCATTTGGAACAGATTGTTAGGT 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 779 GTTATTTGTCTAGAATGCCGAAGCCTCAATATGATGGGCATTTGGAACAGATTGTTAGGT 838
Qy 541 TGGTGGGGGAAGCGAAGAGGCCGGTTTTGTATGTGGGTGGTGGGTGTTTGAATTCGGATG 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 839 TGGTGGGGGAAGCGAAGAGGCCGGTTTTGTATGTGGGTGGTGGGTGTTTGAATTCGGATG 898
Qy 601 ATGAGTTGAGGCGGTTTGTGGAGCTTACGGGGATTCCGGTTGCGAGTACTTTGATGGGGC 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 899 ATGAGTTGAGGCGGTTTGTGGAGCTTACGGGGATTCCGGTTGCGAGTACTTTGATGGGGC 958
Qy 661 TCGGAGCGTACCCTGCTTCGAGTGATTTGTCGCTTCATATGCTTGGGATGCATGGTACGG 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 959 TCGGAGCGTACCCTGCTTCGAGTGATTTGTCGCTTCATATGCTTGGGATGCATGGTACGG 1018
Qy 721 TTTATGCGAATTATGCGGTTGATAAGAGTGATTTGTTGCTTGCGTTTGGGGTGCGGTTTG 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1019 TTTATGCGAATTATGCGGTTGATAAGAGTGATTTGTTGCTTGCGTTTGGGGTGCGGTTTG 1078
Qy 781 ATGATCGTGTGACGGGGAAGCTTGAGGCGTTTGCTAGTAGGGCGAAGATTGTTCATATTG 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1079 ATGATCGTGTGACGGGGAAGCTTGAGGCGTTTGCTAGTAGGGCGAAGATTGTTCATATTG 1138
Qy 841 ATATTGATCCTGCTGAAATTGGGAAGAATAAGCAGCCTCATGTGTCGATTTGTGGTGATA 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1139 ATATTGATCCTGCTGAAATTGGGAAGAATAAGCAGCCTCATGTGTCGATTTGTGGTGATA 1198
Qy 901 TTAAGGTCGCGTTACAGGGTTTGAACAAGATTTTGGAGGAAAAGAATTCGGTGACTAATC 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1199 TTAAGGTCGCGTTACAGGGTTTGAACAAGATTTTGGAGGAAAAGAATTCGGTGACTAATC 1258
Qy 961 TTGATTTTTCGACCTGGAGAAAGGAATTGGATGAACAAAAAATGAAGTTCCCGTTGAGCT 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1259 TTGATTTTTCGACCTGGAGAAAGGAATTGGATGAACAAAAAATGAAGTTCCCGTTGAGCT 1318
Qy 1021 TTAAAACGTTTGGCGAAGCGATTCCTCCACAGTATGCTATTCAAGTTCTTGATGAGTTAA 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1319 TTAAAACGTTTGGCGAAGCGATTCCTCCACAGTATGCTATTCAAGTTCTTGATGAGTTAA 1378
Qy 1081 CGGGCGGGAATGCAATTATTAGCACCGGTGTCGGGCAACATCAGATGTGGGCTGCTCAGT 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1379 CGGGCGGGAATGCAATTATTAGCACCGGTGTCGGGCAACATCAGATGTGGGCTGCTCAGT 1438
Qy 1141 TTTACAAATACAACAAACCTAGACAATGGCTGACGTCG 1178
||||||||||||||||||||||||||||||||||||||
Db 1439 TTTACAAATACAACAAACCTAGACAATGGCTGACGTCG 1476
Kmiec et al teach methods and oligonucleotides for targeted modification of AHASL genes (Table 11 on pg. 19-28; claim 1 and 12). Kmiec et al teach making alterations at several positions of the AHASL of Arabidopsis and a number of other species (Table 11, beginning at pg. 19, paragraph 120). Kmiec et al teach using the methods of their invention in sunflower (pg. 4, paragraph 19).
At the time the invention was made, it would have been prima facie obvious to use the oligonucleotide-based mutagenesis method of Kmiec et al or the EMS-based mutagenesis and selection method of Jander et al and introduce the A122T substitution into the AHASL1 gene of a sunflower plant; including wherein the plant comprises the sequence of Kolkman et al. Given the teachings of Kolkman et al, the resultant sunflower plant, obtained either using the selection method of Jander et al or the direct mutagenesis method of Kmiec et al, would comprise the SEQ ID NO: 1 with a mutation that would result in the A107T substitution in the protein of SEQ ID NO: 2. The plants thus obtained would read on sunflower line GM40 and GM1606 (the only described traits of which is the presence of the A107T substitution) as well as on the progeny or descendants of said plants. In addition, given that both methods mutate the endogenous gene, and neither involves introducing a transgene into the sunflower genome, the resultant plants would be considered “non-transgenic.”
It would have been also obvious to use said methods to introduce another substitution conferring tolerance to AHAS inhibitors into sunflower AHASL1, including A205V or P197L. A plant comprising such additional substitution would be tolerant to sulfonylureas as well.
It would have been prima facie obvious to use the resultant sunflower plants in a method of post-emergence weed control, such as the method suggested by Jander, using any appropriate imidazolinone to which the A122T substitution confers tolerance, including imazapyr or imazamox; or using a sulfonylurea to which the A205V or P197L substitutions confer tolerance, including chlorimuron-ethyl; wherein the herbicide is applied post-emergence, in a sprayable solution, to weeds and the resistant sunflower plants. Harvesting the seed from said treated and grown plant would have been obvious in view of the teachings of Kolkman et al, and in view of the fact that sunflower is a seed crop. Harvesting said seed would make obvious the step of “selecting” a treated plant, as recited in the new claim 28. It would have been obvious to apply imazapyr at any appropriate application rate, such as 78 g ai/ha as taught by Jander et al.
With regard to tolerance to 160 g ai/ha imazapyr, given the teachings of Jander et al and Kolkman et al, one would have reasonably expected at least some level of tolerance to said application rate of imazapyr in sunflower plants comprising the A122T substitution, particularly in combination with the A205V or P197L substitution, including wherein at least some plants show no or littel injury relative to control plants. It is noted that the claims encompass any type of herbicide injury.
One would have been motivated to combine said teachings given the express suggestion of Jander et al and given the agronomic desirability of sunflower plants resistant to AHAS inhibitors. Given the conserved nature of positions A122, A205, and P197, the fact that they are known to confer tolerance to AHAS-inhibiting herbicides in plants, and given the fact that Jander et al and Kmiec et al successfully reduced their inventions to practice, one would have had reasonable expectation of success, in using the mutagenesis method of either Jander et al or Kmiec et al to arrive at the plants of the instant claims and in using them in the claimed method.
12. Claims 15 and 16 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jander et al (US Application No. 2003/0097692 A1, published May 22, 2003), in view of Kolkman et al (Theor. and Appl. Genet. (2004) 109:1147-1159) and Kmiec et al (U.S. Patent Application No. 2003/0236208 A1, published December 25, 2003), as applied to claim 1, and further in view of Public Release Summary on Evaluation of Imazamox; National Registration Authority (Canberra, Australia, 2000). Applicant’s argument submitted on March 2, 2026 has been fully considered but it is not persuasive.
The claims are drawn to the method of claim 1, wherein the effective amount of a herbicide is effective to kill a weed of the genera recited in claim 15 or 16. It is noted that the claims do not exclude the application of AHAS inhibiting herbicides other than imazapyr.
The teachings of Jander et al, Kolkman et al, and Kmiec et al are set forth above. The references do not expressly teach herbicide application rates that are effective to kill weed species from the recited genera, such as Xanthium or Echinochloa.
Public Release Summary on Evaluation of Imazamox teaches that 50 g ai/ha of imazamox was sufficient to control a variety of weeds, including Xanthium pungens (instant claim 15) and Echinochloa crus-galli (instant claim 16).
At the time the invention was made, it would have been prima facie obvious to one of ordinary skill in the art to modify the method made obvious by the teachings of Jander et al, Kolkman et al, and Kmiec et al, and apply imazamox to resistant sunflower plants and weeds, at concentrations of at least 50 g ai/ha and up to 100 g ai/ha as taught by Kolkman et al, in order to control Xanthium pungens and Echinochloa crus-galli, or any of the species taught by the Public Release Summary on Evaluation of Imazamox.
One would have been motivated to do so given the express teachings of the Public Release Summary on Evaluation of Imazamox. Given the fact that the plants of Kolkman et al were resistant to up to 100 g ai/ha of imazamox, and given the fact that 50 g ai/ha was sufficient to control said weeds, one would have had reasonable expectation of success.
13. Claim 21 remains rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jander et al (US Application No. 2003/0097692 A1, published May 22, 2003), in view of Kolkman et al (Theor. and Appl. Genet. (2004) 109:1147-1159) and Kmiec et al (U.S. Patent Application No. 2003/0236208 A1, published December 25, 2003), as applied to claim 1, and further in view of Fernandez-Martinez et al (Euphytica (1989) 41:39-51). Applicant’s argument submitted on March 2, 2026 has been fully considered but it is not persuasive.
The teachings of Jander et al, Kolkman et al, and Kmiec et al are set forth above. The references do not expressly teach a sunflower seed comprising at least 85% of extractable oleic acid.
Fernandez-Martinez et al teach sunflower lines that are true breeding for high oleic acid content (average of higher than 85%) (Abstract; pg. 41, both col.).
At the time the invention was made, it would have been prima facie obvious to further modify the method made obvious by the teachings of Jander et al , Kolkman et al, and Kmiec et al by introducing the A122T substitution into the plant of Fernandez-Martinez et al, and use the resultant plant in the method for treating sunflower, with reasonable expectation of success. One would have been motivated to combine said teachings in view of the desirability of a sunflower plant comprising high oleic content (as taught by Fernandez-Martinez et al and known in the art), which plant is also tolerant to AHAS inhibiting herbicides.
14. Claim 23 remains rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jander et al (US Application No. 2003/0097692 A1, published May 22, 2003), in view of Kolkman et al (Theor. and Appl. Genet. (2004) 109:1147-1159) and Kmiec et al (U.S. Patent Application No. 2003/0236208 A1, published December 25, 2003), as applied to claims 1 and 22, and further in view of Hager et al (Postemergence Control of Volunteer Corn in Soybeans; The Bulletin, Pest Management and Crop Development Information for Illinois, June 12, 1998). Applicant’s argument submitted on March 2, 2026 has been fully considered but it is not persuasive.
The claim is directed to the method of claim 19, wherein the weeds comprise crop plants growing in an undesired location.
The teachings of Jander et al, Kolkman et al, and Kmiec et al are set forth above. The references do not expressly teach applying an AHAS inhibitor to control volunteer crop plants.
Hager et al teach that “Several ALS-inhibiting soybean herbicides can also be used to control volunteer SR corn. Imazaquin (Scepter) is often applied at half rate for volunteer corn control. Imazamox (Raptor) controls or suppresses volunteer corn, and imazethapyr (Pursuit) can be used to suppress volunteer corn.” (see page 1 of the document).
At the time the invention was made, it would have been prima facie obvious to modify the method of claims 1 and 19, made obvious by the teachings of Jander et al, Kolkman et al, and Kmiec et al, and apply an imidazolinone herbicide, such as those taught by Hager et al, to any volunteer crop, including maize or soybean, that is sensitive to said herbicides. This would have also been obvious as a matter of standard industry practice as well as the teachings of Jander et al regarding weed control methods.
Response to Arguments.
Applicant reiterates the previously submitted arguments (page 7 of the Remarks). Applicant argues that Jander does not teach how to obtain the A122T substitution “in an endogenous sunflower AHASL” (page 7).
Applicant argues that “Kolkman reports molecular characterization of AHASL biomolecules from wild, weedy sunflowers, discovered in naturally occurring native sunflower populations. Weedy sunflowers are not sunflower crops (domesticated sunflowers commonly grown as crop plants). For example, a weedy sunflower plant produces up to 35 flowers ("heads"), each bearing about 136 seeds per head, the seeds weighing 6.5-9 mg each. In stark contrast, a sunflower crop plant produces one flower/head bearing 1000-2000 seeds, each weighing 110-190 mg. In addition, these two belong to different Helianthus annuus subspecies: wild, weedy sunflowers belong to H. annuus ssp. lenticularis, whereas sunflower crops belong to H. annuus ssp. macrocarpus. Kolkman provides no teaching or suggestion regarding how to obtain an A122T substitution in an endogenous AHASL of a sunflower crop plant” (page 8 of the Remarks). Applicant argues that Kmiec does not teach how to introduce the A122T substitution into a sunflower plant (pages 8-10 of the Remarks).
To the extent that the Remarks reiterate Applicant’s previously submitted arguments, those were considered in detail in the previous Office Action and remain not persuasive for the reasons of record. The Examiner maintains that all of the evidence submitted by Applicant during the prosecution history of the instant application, including an expert declaration, has been extensively considered by the Examiner.
With regard to the teachings of Kolkman, the argument is not persuasive. Applicant’s statements regarding the “weedy sunflower plant” are not supported by any factual evidence, such as an expert declaration, and thus amount to attorney opinion. It is noted that arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). MPEP 716.01(c).
Moreover, it is unclear how Applicant’s statements regarding the teachings of Kolkman support the argument of non-obviousness, as no clear explanation is supplied. The “wild biotypes of cultivated sunflower” (see Kolkman, Abstract) and the cultivated varieties belong to the same species. Position A122 is located in one of the five AHASL domains that are highly conserved not only between the cultivated and “wild” sunflowers, but across all crops in which the enzyme has been studied. This is consistent with the teachings of Kolkman who teach the wild-type AHASL from a “wild biotype” of a sunflower plant that shares 99.9% sequence identity to the instant SEQ ID NO: 1, with the only difference being the A122T substitution, which would have been prima facie obvious to introduce.
Applicant’s argument directed to the operability of Kmiec et al was addressed in the previous Office Actions and remains not persuasive. Kmiec et al teach that their methods could be used to design oligonucleotides targeting genes and introducing substitutions not expressly listed, and Applicant provided no factual evidence to the contrary (see paragraphs 19-21 and claim 1 of Kmiec et al, for example). Moreover, as set forth in the rejection above, the method of Kmiec was not the only method one of ordinary skill in the art could have predictably used at the time of invention to introduce a known point mutation into an AHASL gene of a sunflower plant.
The Examiner maintains that the relative position A122 is located in one of the five domains of the AHAS that are conserved in all crop species in which the enzyme has been studied (see, for example, Kolkman et al). At the time of invention, the A122T was a well-known substitution, whose imidazolinone tolerance characteristics had not only been extensively characterized but also utilized commercially (see Jander et al, Kolkman et al; Tan et al).
Introducing it into the sunflower AHASL would have been an obvious way to obtain an imidazolinone-tolerant sunflower, and could have been readily achieved using any number of mutagenesis methods known in the art at the time of invention. Moreover, Jander et al expressly suggest introducing an AHASL1 comprising the A122T substitution into sunflower. These teachings would have been sufficient to motivate one of ordinary skill in the art to make the sunflower plant used in the claimed method with reasonable expectation of success. Further, one would reasonably expect that a sunflower plant comprising the A122T substitution would have the recited phenotype of imidazolinone tolerance, and one would reasonably expect to use said plant in a method of treating a plant with an imidazolinone. The rejection is maintained.
Double Patenting
15. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
16. Claims 1, 2, 5, 8-13, 18, 19, 20, 23, 26-28 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over, 16, 17, 105-107, 112, and 113 of copending Application No. 15/054,883 (reference application).
The claims of the co-pending application are directed to a method of controlling weeds comprising the use of sunflower plant or seed of line GM40 or GM1606. The instant claims are drawn to a method of controlling weeds including the method comprises the use of sunflower plants or seed of lines GM40 or GM1606, including wherein the weeds comprise a volunteer crop plant.
Given that the plant of the co-pending application will read on the plant of the instant claims and given that the herbicide application rates of the co-pending claims will encompass the rates in the instant application, the claims of the co-pending application make obvious the invention of the instant claims. It is noted that SEQ ID NO: 2 of the instant claims is identical to SEQ ID NO: 2 of the co-pending application. The application rate of imazapyr recited in the instant claim 1 would have been made obvious by the rates recited in claim 16 of the co-pending application. Harvesting the seed of the plant of the co-pending application would have been obvious as a matter of standard industry practice, given that sunflower is a seed crop. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
17. Claim 21 remains rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16 and 17 of copending Application No. 15/054,883, in view of Fernandez-Martinez et al (Euphytica (1989) 41:39-51).
The instant claim is directed to the method of claim 20, wherein the at least one seed comprises extractable oil comprising at least 85% oleic acid. Fernandez-Martinez et al teach sunflower lines that are true breeding for high oleic acid content (average of higher than 85%) (Abstract; pg. 41, both col.). It would have been obvious to modify the method of claim 20 by applying it to the plant of Fernandez-Martinez et al, and to harvest the resultant seed, in view of the desirability of a sunflower seed with high oleic acid content. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that “Applicant will consider filing a terminal disclaimer upon an indication that the claims are otherwise in condition for allowance” (page 10 of the Remarks).
This is not found to be persuasive. No claims are currently allowable and no terminal disclaimer has been filed. The rejection is maintained.
Conclusion
18. No claims are allowed.
19. THIS ACTION IS MADE FINAL. 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.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYKOLA V KOVALENKO whose telephone number is (571)272-6921. The examiner can normally be reached Mon.-Fri. 9:00-5:30 PST.
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/MYKOLA V. KOVALENKO/Primary Examiner, Art Unit 1662
Prosecution Insights