DETAILED ACTION
Status of the Application
1. The present application is being examined under the pre-AIA first to invent provisions.
2. Claims 16, 17, 86-107, and 112-115 are pending.
3. Claims 86-96 remain withdrawn from consideration.
4. Claims 16, 17, 97-107, and 112-115 are examined herein.
Continued Examination Under 37 CFR 1.114
5. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 25, 2024 has been entered.
Election/Restrictions
6. Applicant’s election without traverse of Group I, claims 16-18 in the reply filed on March 30, 2018 is acknowledged. Claims 86-96 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 30, 2018. In the previous amendments, Applicant added claims 114 and 115 Given that the claims would have been included in the elected Group, they were examined.
Claim Rejections - 35 USC § 112 - Fourth Paragraph
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 101-103 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 they depend, or for failing to include all the limitations of the claim upon which they depend. Applicant's arguments filed on September 25, 2025 have been fully considered but they are not persuasive.
Claims 101-103 are drawn to method of claim 16, wherein the plant possesses a phenotype, as recited. The phenotype of tolerance is already required by claim 16 and claims 101-103 merely specify how that phenotype is determined. This does not introduce any structural limitations to the plant of claim 16, beyond the mutant AHASL recited in in claim 16; nor otherwise limit the active steps of the method. For these reasons, claims 101-103 fail to properly further limit the subject matter of the claim upon 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 maintains previously submitted arguments (page 9 of the Remarks).
Applicant arguments were addressed in the previous Office Action and remain not persuasive for the reasons of record. There is also no dispute that functional limitations may limit a structure of a product, but that is not the case here. Although all limitations of a claim are considered during examination, not all of them carry equal patentable weight. The Examiner maintains that a dependent claim that attempts to further limit a base claim drawn to a method of using a product, must either introduce further structural limitations to said product, or otherwise limit an active method step. The dependent claims at issue here fail to do that. The rejection is maintained.
Claim Interpretation
9. The following is noted with regard to claim interpretation Claim 16 requires that the progeny plants comprise SEQ ID NO: 2, but does not limit the progeny by a filial generation. As a result, the claims are given their broadest reasonable interpretation as encompassing any sunflower plant comprising SEQ ID NO: 2 and having the resistance characteristics conferred by the A107T substitution.
Applicant describes sunflower plants of lines GM40 and GM1606 as comprising the A122T (A107T in sunflower numbering) substitution in the AHASL and being resistant to imidazolinone AHAS inhibitors as a result (Examples 3 and 7-8; Table 5). That is the only herbicide resistance characteristic of the GM40 and GM1606 described in the specification. As a result, the claims are given their broadest reasonable interpretation as encompassing any sunflower plant comprising SEQ ID NO: 2 and having the resistance characteristics conferred by the A107T substitution.
With regard to the limitation “wherein said plant or a sunflower plant grown from said seed exhibits tolerance to 300 gm active ingredient per hectare (gm ai/ha) of imazamox or 360 gm ai/ha of imazapyr, which tolerance is greater than the tolerance of a sunflower plant that comprises in its AHASL1 protein an A190V substitution,” it recites the property of a plant used in the claimed method, and does not limit the active steps of the method. It is also noted that the limitation does not specify the level of tolerance at the recited applications rates. Thus, the method of claim 16 (in step (b)) will encompass the application of any effective amount of any imidazolinone herbicide, so long as that amount is sufficient to control weeds.
In the instant amendments, Applicant add the following limitation to claim 16, part (a)(ii): “which gene is present in said seed or progeny as a result of breeding from line GM40 or GM1606.” This is read as a product-by-process limitation, which does not introduce any structural features to the “sunflower plant or seed that is a progeny of line GM40 or GM1606” beyond the presence of the “AHASL gene encoding the AHASL1 protein having the amino acid sequence of SEQ ID NO: 2.” See MPEP 2113.
Claim Rejections - 35 USC § 103
10. The following is a quotation of 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 of this title, 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 16, 17, 97, 101-103 and 112-113 remain rejected under 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 arguments filed on September 25, 2025 have been fully considered but they are not persuasive.
The claims are directed to a method for controlling weeds in a field of a sunflower plant, comprising growing a sunflower plant that is a progeny of line GM40 or GM1660, comprising herbicide tolerance characteristics of said lines and comprising an AHASL gene that encodes the AHASL1 protein with the amino acid sequence of SEQ ID NO: 2.
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 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). Jander et al teach specific application dosages of imazethapyr, including in a sprayable solution (Example 1).
Jander et al do not teach a plant comprising sunflower AHASL1 comprising a threonine at position 107.
Kolkman et al teach a sunflower plant comprising at least one copy of an AHASL polynucleotide encoding an herbicide resistance AHASL protein (Fig. 2 on pg. 1152). Kolkman et al teach that a proline to leucine mutation at position 182 and an alanine to valine mutation at position 190 of AHASL (in sunflower) confer resistance to herbicides, such as imazethapyr and chlorimuron (pg. 1153, right col; pg. 1157). Kolkman et al teach introgressing resistance genes to AHASL inhibiting herbicides from resistant populations into elite inbred lines for the purpose of developing herbicide resistant sunflower cultivars and hybrids (Kolkman et al pg. 1148, left col., second full paragraph). Kolkman et al teach that in plants, five highly conserved amino acids, A122, P197, W574, and S653 (in Arabidopsis, corresponding to A107, P182, W559, and A638 in sunflower), when mutated, confer resistance to one or more AHAS-inhibiting herbicides (pg. 1148, 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). 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, and also makes obvious at least one nucleic acid sequence encoding it.
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 method of Jander et al and introduce the A122T (A107T) substitution into the AHASL1 gene of a sunflower plant; including wherein the plant comprises the sequence of Kolkman et al. 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 of said plants. It would have been also obvious to introduce the mutant AHASL1 gene into a tolerant sunflower plant via introgression as taught by Kolkman et al. The resultant plant would also read on the plant used in the claimed method.
Given the teachings of Jander et al and Kolkman et al, one would have reasonably expected that the resultant plants would be resistant to imidazolinone herbicides, including imazamox or imazapyr. The tolerance to specific application rates would have naturally flowed from the structure of said plants, which structure would have been prima facie obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In addition, said tolerance would not be unexpected given that the A122T substitution results in tolerance to imidazolinone herbicides, as taught by Jander et al, for example.
It would have been obvious to use the resultant plants or their seeds in a method of weed control, using any appropriate imidazolinone herbicide, such as those taught by Kolkman et al and Jander et al, including imazapyr or imazethapyr, wherein the herbicide is applied to the resistant sunflower plant and the weeds, including wherein the herbicide is applied in a sprayable solution by spraying, including “atomizing,” and including wherein the weeds are killed or their growth is inhibited, as suggested by Jander and as a matter of routine industry practice.
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 that Jander et al and Kmiec et al successfully reduced their inventions to practice, given the limited number of known herbicide resistance AHAS mutations, and given the conserved nature of the enzyme, as taught by Kolkman et al, and well-known in the art, one would have had reasonable expectation of success of using the mutagenesis method of either Jander et al or Kmiec et al to arrive at the instant invention.
12. Claims 98-100 and 104-105 remain rejected under 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 16 and 97, and further in view of Alister et al (Crop Protection (2005) 14:375-379, published April 2005). Applicant's arguments filed on September 25, 2025 have been fully considered but they are 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 the monocot and dicot weeds recited in the instant claims 99 and 100 or applying an imidazolinone herbicide to a tolerant sunflower and said weeds. The references do not expressly teach applying an imidazolinone and another herbicide or using a detergent.
Alister et al teach that imidazolinones, including imazapyr, imazapic, imazapyr, and imazethapyr, effectively control a number of dicot weeds, including Setaria sp., Amaranthus sp., Echinochloa sp., among others (Abstract; Table 3). Alister et al teach that imidazolinones are known for their herbicidal effect at low doses and are effective at controlling a wide spectrum of weeds (pg. 375, both col.). Alister et al teach effective application doses of 19-95-39.9 g ai/ha for imazapyr and 59.85-119.7 g ai/ha for imazapic (Table 3).
Alister et al teach applying three imidazolinones herbicides, imazapyr, imazapic and imazethapyr, to imidazolinone resistant maize plants, and teach using a hydrocarbon petroleum adjuvant (“Dash”) in the herbicide mixture (page 376, right col). One of ordinary skill in the art would readily recognize that said adjuvant is a surfactant (detergent).
At the time the invention was made, it would have been prima facie obvious to one of ordinary skill in the art to further modify the method made obvious by the teachings of Jander et al, Kolkman et al, and Kmiec et al, and apply an appropriate dose of an imidazolinone herbicide to the weeds growing in the vicinity of a tolerant sunflower plant comprising the A107T AHASL1 substitution, including wherein the weeds are any of the genera taught by Alister et al. It would have been further obvious to apply more than one imidazolinone herbicide in a formulation, and to use any appropriate surfactant adjuvant, such as the hydrocarbon petroleum one taught by Alister et al.
One would have been motivated to do so, given the teachings of Alister et al, and the art-recognized property of imidazolinone herbicides to control a variety of monocot and dicot weed species. One would have been motivated to use more than one herbicide and a surfactant in order to improve the efficiency of weed control, as a matter of standard industry practice and in view of the teachings of Alister et al and Jander et al.
13. Claims 106 and 107 remain rejected under 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 16, 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 arguments filed on September 25, 2025 have been fully considered but they are not persuasive.
The claims are directed to the method of claim 16, wherein the weeds comprise crop plants growing in an undesired location, including wherein the crop is maize or soybean.
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 imidazolinone 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 claim 16, 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.
14. Claims 114 and 115 remain rejected under 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 16 and further in view of Hacker et al (U.S. Patent 6,221,809, issued on April 24, 2001). Applicant's arguments filed on September 25, 2025 have been fully considered but they are 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 applying an imidazolinone herbicide via dusting, or wherein the herbicide is present at 0.0001% to 10% by weight.
Hacker et al teach compositions comprising AHAS inhibiting herbicides, including sulfonylureas and imidazolinones at 0.1% to 99% active ingredient by weight, wherein the formulation is a “dust” (claims 1, 24 and 25).
It would have been prima facie obvious to one of ordinary skill in the art at the time of invention to modify the method made obvious by the teachings of Jander et al, Kolkman et al, and Kmiec et al, and apply an imidazolinone in a composition taught by Hacker et al. One would have been motivated to combine said teachings given the suggestion of Hacker et al. This also would have been obvious as a matter of routine industry practice.
Response to Arguments
Applicant maintains previously submitted arguments, including those directed to the motivation to combine the teachings of the cited art, the recited phenotype, to hindsight reasoning, reasonable expectation of success, and the teachings of Kmiec et al (pages 9-10 of the Remarks). Applicant argues that the rejection “fails to make a proper determination of the relevant field of endeavor” (pages 10-11 of the Remarks).
Applicant’s arguments, including those directed to motivation, the property of herbicide tolerance, hindsight reasoning, and reasonable expectation of success were addressed in detail in the previous Office Actions and remain unpersuasive for the reasons of record. The Examiner maintains that the substitution at issue was well-characterized in the art at the time of filing. Jander et al successfully used the EMS mutagenesis/herbicide selection pressure method to introduce said substitution into the Arabidopsis AHASL, and teach a sunflower cell comprising said mutated AHASL (Examples 1-2, claims 1-5). Applying said method to introduce a known substitution located in a highly conserved AHASL domain into a dicot crop like sunflower would have been predictable and readily achievable. Besides the art-standard EMS mutagenesis/herbicide selection method of Jander et al, one could have predictably used the oligonucleotide-based targeted mutagenesis method of Kmiec et al to introduce the A122T substitution into the sunflower AHASL. Introgressing the resultant mutant AHASL into another sunflower plant would have been obvious as well.
Regarding the “field of endeavor” argument, it is not found to be persuasive either. By combining the teachings of the cited art, one of ordinary skill in the art would have predictably arrived at a sunflower plant whose structure would read on the structure of the plant used in the claimed method. The art would have also made obvious the active steps of the method. For this reason, the art is directly relevant to the “field of endeavor” of the instant invention. The rejection is maintained.
Conclusion
15. No claims are allowed.
16. 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.
17. 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