DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
2. Claims 51-65, 69-71, and 74-79 are pending.
3. Claims 51-65, 69-71, and 74-79 are examined.
Continued Examination Under 37 CFR 1.114
4. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 17, 2025 has been entered.
Claim Rejections - 35 USC § 112 - Indefiniteness
5. 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.
6. Claims 51-65, 69-71, and 74-79 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 arguments submitted on December 17, 2025 have been fully considered but they are not persuasive.
Claim 51, as amended, recites: “wherein the herbicide-resistant sunflower plant has been identified by a method for genotyping a sunflower AHASL1 gene comprising: obtaining DNA from the herbicide-resistant sunflower plant or from a plant of a line to which it belongs.” The recitation renders the claim indefinite. It is unclear what is meant by the term “a line to which it belongs.” Specifically, it is unclear how “the herbicide-resistant sunflower plant” differs from “a line,” as recited in said limitation in the alternative. It is thus unclear how or whether the “wherein” clause at issue limits the scope of claim 51.
Further, claim 51 recites the following two clauses: “wherein the herbicide-resistant sunflower plant having said A122T allele and said A205V allele has a phenotype of phytotoxicity … comprising a phytotoxicity within the range of phytotoxicities of sunflower plants that have homozygous A122T/A122T alleles that that together have an average phytotoxicity in the range of 3-5% from 200 g ai/ha imazamox at 21 days after treatment;” and “wherein the herbicide-resistant sunflower plant, having said A122T allele and said P197L allele, has a phenotype of phytotoxicity, from 10 g Al/ha metsulfuron at 14 days after treatment, comprising a phytotoxicity index within the range of phytotoxicities of sunflower plants that have homozygous P197L/P197L-alleles and that together have an average phytotoxicity index of 0.10 from 10 g Al/ha metsulfuron at 14 days after treatment.” These recitations render the claim indefinite.
It is unclear how the term “phytotoxicity” or “phytotoxicity index” would apply to a single sunflower plant recited in both “wherein” clauses, given that the “range of 3-5%” and “average phytotoxicity index” appear to apply to a group of plants. The specification does not teach how “phytotoxicity” could be determined for a single plant. It is also unclear what “within the range of phytotoxicities” means in the above two clauses. For example, it is unclear whether the range would encompass the values above or below 3% and 5%. It is noted that the specification, on page 56, in lines 5-10, appears to refer to the phytotoxicity of “2-3%” as being “equivalent” to “3-5%.”
Given that claims 52-65, 70, 71, and 74-80 depend from claim 51 and fail to recite additional limitations overcoming its indefiniteness, the claims are indefinite as well.
Response to Arguments
Applicant argues that the claims have been amended, that the term “line” is recited in the specification multiple time, and that it would be clear how to apply the term “phytotoxicity” to a single plant; Applicant cites page 48 of the specification for support (page 8 of the Remarks).
This is not found to be persuasive. The claims, as instantly amended, remain rejected for the reasons set forth above. Regarding the term “line” the issue is the entire phrase in which the term is used, as set forth above, not the term itself.
With regard to the term “phototoxicity,” the argument is not persuasive either. The fact that the plan injury can be scored on a scale from 0 to 9 in no way means that “a score of 0.5 would equate to approximately 5% phytotoxicity for a single plant” as Applicant argues. There is no support for that conclusion either on page 48 or elsewhere in the specification. The specification and the Figures clearly refer to groups of plants, and include the as is routine in the art. The rejection is maintained.
Claim Rejections - 35 USC § 112(d)
7. 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.
8. Claims 52, 53, and 65 remain 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. Applicant’s arguments submitted on December 17, 2025 have been fully considered but they are not persuasive.
Claims 52, 53, and 65, which are dependent from claim 51, recite either the herbicide tolerance property of the plants of the base claims, or a primer used in a process to “identify” the plant of claim 51. The property of tolerance to AHAS inhibiting herbicides is inherent in the plants of claim 51, which is drawn to “an herbicide-resistant sunflower plant,” and recites the presence of the substitutions that result in AHAS inhibitor resistance. Thus, claims 52 and 53 merely recite an inherent property of the plant of claim 51.
Similarly, a primer recited in claim 65, which primer is used in a process of “genotyping” the plant of claim 51, merely limits the process used to obtain the product of claim 51, without setting forth any further structural limitations to that product. Thus, a sunflower plant that reads on claim 51 will also read on the sunflower plant of claim 65. See MPEP 2113. For these reasons, the claims fail to properly limit the base claims from which they depend.
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.
Response to Arguments
Applicant argues that the claims further limit the claims from which they depend. (page 8 of the Remarks). This is not found to be persuasive. Applicant has not presented any substantive reasoning to support said conclusion. The claims remain rejected as set forth above.
Claim Interpretation
9. Claim 51 is interpreted as a product-by-process claim that reads on a product (“An herbicide resistant sunflower plant”) and includes at least one method step (“has been identified”). “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” ln re Thorpe, 777 F.2d 695, 698 (Fed Cir. 1985). MPEP 2113.
In the instant case, the “wherein” clauses in claim 51 are not accorded patentable weight as they do not set forth steps that alter the structure of the claimed sunflower plant or that are required to be performed. The method steps do not further limit or define the structure as they merely recite a process used to identify the claimed plant but do not further limit the structure of the plant itself. Therefore, the claims are limited to and defined by the structure claimed.
Additionally, the claim recites limitations that directly result from the structure of the plant: “wherein the herbicide-resistant sunflower plant has a phenotype of phytotoxicity, from 200 g ai/ha imazamox at 21 days after treatment, comprising a phytotoxicity within the range of phytotoxicities of sunflower plants that have homozygous A122T/A122T alleles that that together have an average phytotoxicity in the range of 3-5% from 200 g ai/ha imazamox at 21 days after treatment.” These features are inherent in a plant that has the alleles with the recited mutation. See Figure 2, for example, where the homozygous A122T and heterozygous A122T/A205V have the same phytotoxicity at 14 days; “Heterozygous A122T/A205V materials showed the same pattern of response as the homozygous A122T/A122T materials.” See pg. 49; and page 56 where phytotoxicity was equivalent at 21 DAT. Therefore, the evidence in the record shows that if the plant comprises the claimed heterozygous allele, the recited phenotype will be inherently present in said plant. Similarly, the combination of A122T and P197L will necessarily result in the claimed phenotype (Table 11).
In claim 70, the limitation “residue from an AHAS-inhibiting herbicide” is interpreted as encompassing a detectable amount of the herbicide. In claim 79, the terms “alkali metal” and “alkaline earth metal” are reasonably interpreted as encompassing salts of said metals, because their elemental form cannot be used in the claimed composition.
Claim Rejections - 35 USC § 103
10. 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.
11. Claims 51-65, 69-71, and 74-79 remain rejected under 35 U.S.C. 103 as being unpatentable over Kolkman et al (Theor. and Appl. Genet. (2004) 109:1147-1159), in view of White et al (Weed Science (2003) 51:845-853), Jander et al (US Application No. 20030097692 Al, published May 22, 2003), Sala et al (US 20110209232, claiming priority to US provisional application 60/695,952, filed July 1, 2005; first published as WIPO publication WO 2007/005581), Penner et al (US Patent No. 5,859,348, issued January 12, 1999), and Tan et al (Pest Mgmt. Sci. (2005) 61:246-257). Applicant’s arguments submitted on December 17, 2025 were fully considered but they are not persuasive.
The claims are directed to an herbicide resistant sunflower plant comprising a first mutant AHASL1 allele comprising the A122T substitution and a second mutant allele comprising the A205V or P197L substitution; a method of controlling weeds comprising applying an effective amount of AHAS-inhibiting herbicide to weeds and to the sunflower plant; a method for combating undesired vegetation comprising contacting sunflower seed with an effective amount of AHAS-inhibiting herbicide before sowing and/or after pregermination.
Kolkman et al teach a sunflower plant comprising at least one copy of an AHASL polynucleotide encoding an herbicide resistant AHASL1 protein (Kolkman et al, Fig. 2 on pg. 1152). Kolkman et al teach that the P182L (instant P197L) and the A190V (instant A205V) substitutions in sunflower AHASL1 confer resistance to imidazolinone herbicides, such as imazethapyr and chlorimuron (Kolkman et al, pg. 1153, right col; pg. 1157). Kolkman et al teach introgressing said mutant AHASL genes from resistant populations into sunflower lines for the purpose of developing herbicide resistant sunflower cultivars and hybrids (Kolkman et al pg. 1148, left col., second full paragraph). This necessarily produces seeds comprising the mutant alleles.
Kolkman et al teach an amino acid sequence that is 99.7% identical to the instant SEQ ID NO: 20. The instant specification defines SEQ ID NO: 20 as truncated sunflower AHASL with the A107T mutation (in the sunflower numbering) (see pg. 11, lines 16-22). The sequence of Kolkman et al differs from the instant SEQ ID NO: 20 at a single amino acid residue: the sequence of Kolkman et al has an alanine at position 107. 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: 20. The sequence alignment is set forth below:
ID Q5VB49_HELAN Unreviewed; 655 AA.
AC Q5VB49;
DT 07-DEC-2004, integrated into UniProtKB/TrEMBL.
DT 07-DEC-2004, sequence version 1.
DT 11-DEC-2019, entry version 72.
DE RecName: Full=Acetolactate synthase {ECO:0000256|RuleBase:RU003591};
DE EC=2.2.1.6 {ECO:0000256|RuleBase:RU003591};
GN Name=AHAS1 {ECO:0000313|EMBL:AAT07322.1};
OS Helianthus annuus (Common sunflower).
OC Eukaryota; Viridiplantae; Streptophyta; Embryophyta; Tracheophyta;
OC Spermatophyta; Magnoliopsida; eudicotyledons; Gunneridae; Pentapetalae;
OC asterids; campanulids; Asterales; Asteraceae; Asteroideae;
OC Heliantheae alliance; Heliantheae; Helianthus.
OX NCBI_TaxID=4232 {ECO:0000313|EMBL:AAT07322.1};
RN [1] {ECO:0000313|EMBL:AAT07322.1}
RP NUCLEOTIDE SEQUENCE.
RX PubMed=15309298; DOI=10.1007/s00122-004-1716-7;
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 imidazolinone
RT or sulfonylurea herbicides in sunflower.";
RL Theor. Appl. Genet. 109:1147-1159(2004).
CC -!- CATALYTIC ACTIVITY:
CC Reaction=H(+) + 2 pyruvate = (2S)-2-acetolactate + CO2;
CC Xref=Rhea:RHEA:25249, ChEBI:CHEBI:15361, ChEBI:CHEBI:15378,
CC ChEBI:CHEBI:16526, ChEBI:CHEBI:58476; EC=2.2.1.6;
CC Evidence={ECO:0000256|RuleBase:RU003591};
CC -!- COFACTOR:
CC Name=Mg(2+); Xref=ChEBI:CHEBI:18420;
CC Evidence={ECO:0000256|RuleBase:RU003591};
CC Note=Binds 1 Mg(2+) ion per subunit. {ECO:0000256|RuleBase:RU003591};
CC -!- COFACTOR:
CC Name=thiamine diphosphate; Xref=ChEBI:CHEBI:58937;
CC Evidence={ECO:0000256|RuleBase:RU003591};
CC Note=Binds 1 thiamine pyrophosphate per subunit.
CC {ECO:0000256|RuleBase:RU003591};
CC -!- PATHWAY: Amino-acid biosynthesis; L-isoleucine biosynthesis; L-
CC isoleucine from 2-oxobutanoate: step 1/4.
CC {ECO:0000256|RuleBase:RU003591}.
CC -!- PATHWAY: Amino-acid biosynthesis; L-valine biosynthesis; L-valine from
CC pyruvate: step 1/4. {ECO:0000256|RuleBase:RU003591}.
CC -!- SIMILARITY: Belongs to the TPP enzyme family.
CC {ECO:0000256|RuleBase:RU003591}.
CC ---------------------------------------------------------------------------
CC Copyrighted by the UniProt Consortium, see https://www.uniprot.org/terms
CC Distributed under the Creative Commons Attribution (CC BY 4.0) License
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DR EMBL; AY541451; AAT07322.1; -; Genomic_DNA.
DR UniPathway; UPA00047; UER00055.
DR UniPathway; UPA00049; UER00059.
DR GO; GO:0003984; F:acetolactate synthase activity; IEA:UniProtKB-EC.
DR GO; GO:0050660; F:flavin adenine dinucleotide binding; IEA:InterPro.
DR GO; GO:0000287; F:magnesium ion binding; IEA:UniProtKB-UniRule.
DR GO; GO:0030976; F:thiamine pyrophosphate binding; IEA:UniProtKB-UniRule.
DR GO; GO:0009097; P:isoleucine biosynthetic process; IEA:UniProtKB-UniPathway.
DR GO; GO:0009099; P:valine biosynthetic process; IEA:UniProtKB-UniPathway.
DR CDD; cd02015; TPP_AHAS; 1.
DR InterPro; IPR012846; Acetolactate_synth_lsu.
DR InterPro; IPR039368; AHAS_TPP.
DR InterPro; IPR029035; DHS-like_NAD/FAD-binding_dom.
DR InterPro; IPR029061; THDP-binding.
DR InterPro; IPR012000; Thiamin_PyroP_enz_cen_dom.
DR InterPro; IPR012001; Thiamin_PyroP_enz_TPP-bd_dom.
DR InterPro; IPR000399; TPP-bd_CS.
DR InterPro; IPR011766; TPP_enzyme-bd_C.
DR Pfam; PF02775; TPP_enzyme_C; 1.
DR Pfam; PF00205; TPP_enzyme_M; 1.
DR Pfam; PF02776; TPP_enzyme_N; 1.
DR SUPFAM; SSF52467; SSF52467; 1.
DR SUPFAM; SSF52518; SSF52518; 2.
DR TIGRFAMs; TIGR00118; acolac_lg; 1.
DR PROSITE; PS00187; TPP_ENZYMES; 1.
PE 3: Inferred from homology;
KW Amino-acid biosynthesis {ECO:0000256|RuleBase:RU003591};
KW Branched-chain amino acid biosynthesis {ECO:0000256|RuleBase:RU003591};
KW Magnesium {ECO:0000256|RuleBase:RU003591};
KW Metal-binding {ECO:0000256|RuleBase:RU003591};
KW Thiamine pyrophosphate {ECO:0000256|RuleBase:RU003591};
KW Transferase {ECO:0000256|RuleBase:RU003591, ECO:0000313|EMBL:AAT07322.1}.
FT DOMAIN 83..247
FT /note="TPP_enzyme_N"
FT /evidence="ECO:0000259|Pfam:PF02776"
FT DOMAIN 275..407
FT /note="TPP_enzyme_M"
FT /evidence="ECO:0000259|Pfam:PF00205"
FT DOMAIN 469..624
FT /note="TPP_enzyme_C"
FT /evidence="ECO:0000259|Pfam:PF02775"
SQ SEQUENCE 655 AA; 71322 MW; 3AF7DF2D81C31752 CRC64;
Query Match 99.8%; Score 2026; DB 67; 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
Kolkman et al do not teach a sunflower plant comprising two mutated AHASL alleles: one with the A107T (A122T) mutation, and a second one comprising the A190V (A205V) or P182L (P197L) mutation.
Jander et al teach a nucleic acid molecule encoding a functional AHASL that has the A122T substitution (in the Arabidopsis numbering, A107T in sunflower); and an imidazolinone-resistant sunflower plant comprising said nucleic acid (Jander et al, claims 1, 2, 7 and 8).
White et al teach herbicide tolerant sunflower plants comprising a gene encoding the AHASL protein with the A205V substitution (in the Arabidopsis numbering, A190V in sunflower), which plants are tolerant to both chlorimuron-ethyl (a sulfonylurea) and imazethapyr (an imidazolinone) (Abstract; pg. 852, left col. first full paragraph). White et al teach that multiple mutations conferring resistance to AHASL-inhibitors have been found at relative positions P197 and A205 (pg. 850, left col; Table 4).
Sala et al teach a sunflower plant comprising an AHASL polynucleotide encoding an herbicide resistant AHASL with a threonine at position 107, said protein further comprising a leucine at position 182, or further comprising a valine at position 190 (claims 1-7); a seed of said plant (claim 15); a method for controlling weeds near said sunflower plant comprising applying an effective amount of an imidazolinone herbicide, or a sulfonylurea herbicide, a triazolopyrimidine herbicide, a pyrimidinyloxybenzoate herbicide, a sulfonylamino-carbonyltriazolinone herbicide, or mixture thereof to the weeds and to the sunflower plant ( claim 16); wherein said imidazolinone herbicide is selected from the group consisting of: [2-( 4- isopropyl-4-methyl-5-oxo-2-]imidiazolin-2-yl)-nicotinic acid, 2-( 4-isopropyl)-4-methyl-5-oxo-2-imidazolin-2-yl) -3-quinolinecarboxylic acid, [5-ethyl-2-( 4-isopropyl-4-methyl-]5-oxo-2-imidazolin-2-yl) -nicotinic acid, 2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-(methoxymethyl)-nicotinic acid, 2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-methylnicotinic acid, and a mixture of methyl 6-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-m-toluate, methyl [2-( 4-]isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-p-toluate, and mixture thereof (claim 17); wherein said sulfonylurea herbicide is selected from the group consisting of: chlorsulfuron, metsulfuron methyl, sulfometuron methyl, chlorimuron ethyl, thifensulfuron methyl, tribenuron methyl, bensulfuron methyl, nicosulfuron, ethametsulfuron methyl, rimsulfuron, triflusulfuron methyl, triasulfuron, primisulfuron methyl, cinosulfuron, amidosulfiuon, fluzasulfuron, imazosulfuron, pyrazosulfuron ethyl, halosulfuron, and mixtures thereof (claim 18).
Sala et al teach a method for combating unwanted vegetation comprising contacting said seed before sowing and/or after pregermination with an AHAS-inhibiting herbicide (claim 84); including wherein the herbicide is applied as a seed treatment [0156]; wherein said herbicide is selected from the group consisting of an imidazolinone herbicide, a sulfonylurea herbicide, a triazolopyrimidine herbicide, a pyrimidinyloxybenzoate herbicide, and a sulfonylamino-carbonyltriazolinone herbicide, or mixture thereof (claim 85).
Sala et al teach that sunflower plants expressing a mutant AHASL with the A122T or the A205V substitutions showed resistance to imazamox, at 100 g ai/ha and 200 g ai/ha (Figures 4 and 5). Sala et al teach that the A205V, P197L, and A122T substitutions were known in the art to provide herbicide tolerance (Table 4). Sala et a teach that sunflower plants homozygous for the A122T substitution showed greater herbicide tolerance at both 100 g ai/ha and 200 g ai/ha than plants homozygous for A205V (Figure 4 ).
Sala et al teach that “Prior to application, the AHAS-inhibiting herbicide can be converted into the customary formulations, for example solutions, emulsions, suspensions, dusts, powders, pastes and granules. The use form depends on the particular intended purpose; in each case, it should ensure a fine and even distribution of the compound according to the invention” (paragraph 0157).
Sala et al teach using various auxiliaries in their herbicidal compositions, such as emulsifiers, solvents and surfactants, including alkali metal salts of lignosulfonic acid (paragraphs 0158-0163).
Penner et al teach sugar beet plants comprising a nucleic acid sequence encoding a mutated AHASL comprising two mutations: A113T (in sugar beet; 122 in Arabidopsis, 107 in sunflower) and P188S (in sugar beet; 197 in Arabidopsis, and 182 in sunflower) (col. 9, lines 35-55). Penner et al teach that said double mutation provides enhanced resistance to a combination of sulfonylureas and imidazolinones (col. 9, lines 56-59; Fig. 4). Penner et al teach that the resultant resistance is synergistic when compared to the level of resistance afforded by the two mutations individually (Penner et al, col. 10, lines 9-14; Table 2 in col. 10).
Tan et al teach that a substitution at A122 (A107 in sunflower) confers resistance to imidazolinones, while a substitution at P197 (P182 in sunflower) confers resistance to sulfonylureas, but not to imidazolinones (Tan et al, pg. 248, top of right col.).
At the time the invention was made, it would have been prima facie obvious to one having ordinary skill in the art to use the introgression methods taught by Kolkman et al and cross the sunflower plants of Jander et al (comprising the A107T substitution) with the sunflower plants of White et al (comprising the A190V substitution), thus obtaining sunflower plants comprising these two mutations on different AHASL1 alleles. Doing so would produce the instantly claimed plants and seeds, and the resultant plants would comprise “a template” for a first and second PCR reaction as defined in the instant claims.
One would have been motivated to combine said teachings in order to produce a sunflower plant that is tolerant to both sulfonylureas and imidazolinones, as taught by Tan et al, White et al and Sala et al. One would have also been motivated to do so because Sala et al teach sunflower plants comprising the two point mutations at issue on the same AHASL protein, and given the fact the two mutations confer tolerance to different classes of AHAS inhibitors. Therefore, in combining the A122T and A205V mutations, one would have reasonably expected the resultant sunflower plant to exhibit resistance to both sulfonylureas and imidazolinones.
Because Jander et al, Sala et al, and Penner et al successfully reduced their invention to practice, and given that the introgression methods taught by Kolkman et al are standard in the art, one would have had a reasonable expectation of success of producing an herbicide resistant sunflower plant that comprises one allele bearing the A122T mutation and a second allele bearing the A205V mutation.
As a result of the introgression of the A107T mutant allele into a plant comprising another mutant allele, such as A190V, at least some progeny plants would be heterozygous for the two mutations, and one would have expected such plants to exhibit tolerance to both sulfonylureas and imidazolinones, in view of the teachings of Sala et al, White et al, and Tan et al.
Moreover, the levels of phytotoxicity to imazamox of said resultant heterozygous plants relative to said levels for the homozygous plants would have been a property naturally flowing from the structure of said plants, and would amount to a desired result of the claimed method that would have naturally flowed from said prima facie obvious method. “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applying an appropriate imidazolinone, including imazamox, or a sulfonylurea, including metsulfuron, to the resultant plant, and subsequently evaluating the level of the plant's tolerance, would have been prima facie obvious as well, in view of the teachings of Sala et al and White et al - thereby producing a plant that comprises “residue from an AHAS-inhibiting herbicide” as instantly claimed (claims 70-71).
It would have been obvious in an effort to control weeds and/or unwanted vegetation to apply an effective amount of a sulfonylurea and/or imidazolinone herbicide, including those instantly claimed, to the sunflower plants, seeds, and weeds as a seed, soil, and/or foliar treatment, wherein the treatment is in the form of any appropriate formulation, including granular formulation or solution, including wherein the herbicidal composition comprises an auxiliary or surfactant, such as a sodium or potassium salt of lignosufonic acid as taught by Sala et al. One would reasonably expect said treatment to effectively control the growth of weeds and other unwanted vegetation, yet allow the sunflower plants to grow.
Response to Arguments
Applicant reiterates the previously submitted argument that there would have been “no reason to combine the references,” and argues that the combination of the references “does not suggest each and every element of the claimed methods.” Applicant argues that “phenotype” structurally limits the claimed plant and cites the PTAB decision in appeal 2025-003055 for support (page 9 of the Remarks).
Applicant’s previously submitted arguments were considered in detail in the previous Office Actions and remain not persuasive for the reasons of record.
With regard to the cited PTAB decision, Applicant’s argument is not persuasive either. The decision, including the portion cited by Applicant, reflects the facts of a specific case in a different crop species. Applicant has provided no explanation as to how the facts of said unrelated application could be applied to the instant scenario. Nor is there any evidence that the cited decision is precedential legal authority.
The Examiner maintains that the claimed invention amounts to combining two mutant alleles, in the same sunflower plant, wherein both alleles were well-characterized in the prior art. The desirability of combining two AHAS substitutions, including A122T and P197L, or A122T and A205V, in the same sunflower plant, would have been readily apparent to one of skill in the art. For example, as explained in the rejection, the A122T substitution confers tolerance only to imidazolinones, in most species, whereas P197L only to sulfonylureas. Moreover, Sala et al expressly teach combining the A122T substitution with either the P197L or the A205V one, on the same AHASL protein. At the same time, introgressing herbicide tolerance alleles to produce tolerant progeny is routine in the art. The rejection is maintained.
Double Patenting
12. 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 Langi, 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 l.32l(c) or l.32l(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(1)(1) - 706.02(1)(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 l.32l(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 autoprocessed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www .uspto.gov/patents/process/file/efs/guidance/eTD-info-1.jsp.
13. Claims 51-65, 69-71, and 74-76 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 46, 48, 52, 53, 61, and 67-69 of copending Application No. 12/594,289 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims encompass overlapping subject matter.
The instant claims are drawn to an herbicide resistant sunflower plant comprising a first mutant AHASL1 allele comprising the A122T substitution and a second mutant allele comprising either the A205V or P197L substitution; a method of controlling weeds comprising applying an effective amount of AHAS-inhibiting herbicide to weeds and to the sunflower plant; a method for combating undesired vegetation comprising contacting sunflower seed with an effective amount of AHAS-inhibiting herbicide before sowing and/or after pregermination.
The claims of the co-pending application are drawn to a method for producing an herbicide-tolerant sunflower comprising crossing a first sunflower plant comprising the A122T substitution allele with a second sunflower plant comprising the A205V substitution allele thereby obtaining an herbicide tolerant plant that comprises both alleles (claims 46 and 48); and plants made by the methods (claims 52-53). The scope of the claims includes plants comprising both alleles. Also, this method necessarily produces seed comprising both A122T and A205V alleles.
Additionally, claim 46 of the co-pending application recites that the sunflower plant has a phenotype of less phytotoxicity against imazamox at 21 days after treatment - thereby indicating that the herbicide has been applied. Similarly, claims 61-63 and 67-69 recite additional phenotypes providing that the sunflower plant exhibits less phytotoxicity to herbicide after treatment.
With regards to the third “wherein” clause in the instant claim 51, the limitation specifies methods steps that have been used to identify the claimed plant. The claim is thus a product-byprocess claim, wherein the patentability of the product is determined by its structure - i.e., a sunflower plant having one AHASL1 allele with the Al22T mutation and anther AHASL1 allele with either the A205V or P197L mutation.
The co-pending application specifically claims plants that are made by the method claimed - and thus that have this structure. Additionally, the co-pending application teaches that the claimed nucleic acid sequences are effective for identifying the plants (pgs. 10-11; pgs. 34-35), which are the same as the instantly claimed sequences. Therefore, the plants of the co-pending application comprise “a template” for a first and second PCR reaction as defined in the instant claims.
With regards to the dependent claims setting forth the herbicides that the plant is tolerant to: the specification of the co-pending application teaches that these mutations provide tolerance to said herbicides (see pgs. 20-21). Therefore, the properties claimed are necessarily present in the plants produced by the methods of the co-pending application. The specification further provides methods involving the use of at least one of the herbicides as a soil, seed, or foliar treatment, which would control the growth of undesired vegetation or weeds (as instantly claimed) (pgs. 22-23). It would have been obvious to apply an effective amount of an herbicide that the sunflower plant or seed was known to be tolerant to on or around the sunflower plant or seed to control the growth of weeds and other unwanted vegetation. It would have been obvious to apply said herbicide in any common formulation, including granules or sprayable solution. One would do so to limit the competition for resources between the sunflowers and the other vegetation thereby selectively growing the desired sunflower plants. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
The Applicant states that a terminal disclaimer will be considered upon the indication of allowable subject matter (page 10 of the Remarks).
This is not persuasive. For the reasons above, the instant claims remain not patentably distinct from the claims of the co-pending application. Therefore, the provisional rejection is maintained.
Conclusion
14. No claims are allowed.
15. All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
16. 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