DETAILED ACTION
1. The present application is being examined under the pre-AIA first to invent provisions.
Status of the Application
2. Claims 12, 15, 19-28, 31-33, 35-39, 43, 44, 82, 83, 86-88, 92-96, 98, 100 and 101 are pending.
3. Claims 19-28, 31-33, 35-39, 43, and 44 remain withdrawn.
4. Claims 12, 15, 82, 83, 86-88, 92-96, 98, 100, and 101 are examined herein.
5. The rejection of claims 12, 15, 82, 83, 86-88, 92-96, 98, 100 under 35 U.S.C. 112 second paragraph is withdrawn in view of Applicant’s amendments to the claims.
Continued Examination Under 37 CFR 1.114
6. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 16, 2025 has been entered.
Election/Restrictions
7. Applicant’s election without traverse of Group I, claims 12-15, 82, and 83 in the reply filed on February 6, 2018 is acknowledged. Claims 19-28, 31-33, 35-39, 43, 44, and 73 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 February 6, 2018.
In the previous amendments, Applicant added new claim 101. Given that the claim would have been included with the elected Group, it was examined.
Claim Rejections - 35 USC § 112 - New Matter
8. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
9. Claim 101 remains rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant’s arguments submitted on December 16, 2025 have been fully considered but they are not persuasive.
Claims 101, which was added in the previous amendments, contains New Matter for the following reasons. The claim recites “wherein the Phytotoxicity Index is the value, rated on the scale of 0 to 9 with 0 indicating no injury, of the degree of injury observed as leaf deformation and necrosis, determined 14 days after treatment.” There is no sufficient written support for this recitation in the specification. The specification uses the term “Phytotoxicity Index” in three instances, on pages 11 and 67. None of these define the term or otherwise provide written support for the definition recited in claim 101.
In addition, the specific ranges in height and biomass accumulation, as recited in the claim, are not supported either. For example, Figure 11 is the only portion of the disclosure providing data on biomass accumulation in herbicide tolerant and control plants after imazapyr treatment. The data point for the A122T plants treated with the 4x does of imazapyr appears to be between 90 and 100% (it is unclear how the specific value of 93.7% was arrived at) yet the error bar clearly does not extend to 100% of the control, as encompassed by “at least 93.7%.”
Similarly, Figure 10, which shows the effects of imazapyr on “Phytotoxicity Index,” shows the value of approximately 0.5 at the 4x application rate, yet the limitation “0.5 or less” encompasses any value between 0 and 0.05. The originally filed claims similarly fail to provide the written support for the above limitations as well. For these reasons, claim 101 contains New Matter.
Response to Arguments
Applicant argues that “Applicant previously submitted explicit and implicit support for the recited language and maintains that no new matter has been added” (page 8 of the Remarks).
Applicant’s argument regarding written support for the limitations of claim 101 (which were also previously recited in claim 12) were considered in detail in the previous Office Actions and remain not persuasive for the reasons of record.
Claim Rejections - 35 USC § 112 - Indefiniteness
10. 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.
11. Claim 101 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.
The rejection has been modified in view of Applicant’s amendments to the claims. Applicant's arguments filed on December 16, 2025 were fully considered but they are not persuasive.
Claim 101 is indefinite for the following reason. The claim is drawn to the sunflower plant of claim 12. The claims refers to “Phytotoxicity Index,” “height,” and “biomass accumulation” relative to “untreated control plants,” as indication of herbicide tolerance. However, each of these three variables requires a number of plants to provide a valid value (see, for example, pages 67-68 of the specification), yet the claim is drawn to “a sunflower plant.” It is unclear how “average” height, biomass, or phytotoxicity could be determined in the context of a single plant, in view of the wording of the claims and the teachings of the specification, particularly since the claim recites “plants,” in plural, as a control.
Response to Arguments
Applicant argues that claim 12 has been amended to delete the term “average” (page 10 of the Remarks). Applicant’s amendments are acknowledged and the rejection has been modified accordingly. However, the metes and bounds of claim 101 remain unclear for the reasons set forth above.
Claim Rejections - 35 USC § 112 - Fourth Paragraph
12. 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.
13. Claims 96, 98 and 100 remain and claim 101 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 98, 98 and 100 are drawn to a plurality of the sunflower plants of clam 12, including wherein “said sunflower plants” grow in the presence of one or more weeds. Claim 12 is drawn to a sunflower plant, whose structure is defined in the claim. Thus, claim 96, which is drawn to a plurality of the plants of claim 12, encompasses the exact same structural limitations as claim 12, because it does not require any elements beyond the plant of claim 12. The addition of the phrase “comprising the sunflower plant” to claim 96 does not address the issue because the claims still does not require any additional elements besides the presence of a number of plants of claim 12.
The recitation of the weeds in claims 98 and 100 does not add any further limitations to said plant beyond merely reciting the location in which it grows.
Claim 101 recites the phenotype of tolerance previously recited as an optional limitation in claim 12. This property would be inherently present in the plants of claim 12. This is also taught by the instant specification, which does not teach any plants comprising the substitution at issue and not having the phenotypes that appear to fall within the ranges encompassed by the claim (see, for example, Fig. 10 and 11; Example 8).
For these reasons, the claims fail to further properly limit the claim 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.
Applicant argues that the amendments to claim 96 obviate the rejection. This is not found to be persuasive. The amendments are not sufficient to obviate the rejection for the reason set forth above.
Claim Interpretation
14. The following is noted with regard to claim interpretation. The specification teaches that sunflower plants designated GM40 and GM1606 comprise a threonine at position 107 of the full-length sunflower AHASL1 protein (see page 6, last paragraph). The specification teaches that SEQ ID NO: 2 is a partial amino acid sequence of the herbicide resistant sunflower AHASL1 (see Sequence Listing on page 12).
Claim 12 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 “non-transgenic” 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, upon expressing said AHASL1 protein, has a phenotype of 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 that of a sunflower plant that comprises in its AHASL1 protein an A190V substitution,” in claim 12, the limitation recites the property of the claimed plant, and does not limit its structure. The sole structural characteristic of the recited sunflower plants and seeds is the presence of SEQ ID NO: 2. The limitation does not specify the level of tolerance at the recited applications rates. The same reasoning applies to the phenotypes optionally recited in claim 12. In addition, “The fact that [Applicant] 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). It is noted that claim 12 does not require said “optionally” recited phenotypes.
In claim 12, product-by-process limitation “the sequence of said gene having been obtained by chemical mutagenesis without site-directed mutagenesis” is interpreted as not affecting the structure of “said gene” which structure is determined by its sequence of nucleotides not method of production. See MPEP 2113.
In claim 93, the phrase “no injury from the herbicide” does not specify the type of injury, and the term “no injury” is not defined in the claims. As a result, the term is given its broadest reasonable interpretation as encompassing a scenario where only a portion of the plant shows “no injury,” however the injury is determined, from the herbicide. In claims 87 and 88, the term “residue” is interpreted as a detectable amount of the recited herbicide.
Claim 94 is directed to the sunflower plant of claim 12, “wherein each line comprises at least two copies of an acetohydroxyacid synthase large subunit (AHASL) gene encoding an AHASL1 protein having the amino acid sequence of SEQ ID NO: 2.” The term “each line” appears to refer to part (a)(i) of claim 12, which recites “sample seed of each line.” Part (a)(i), however, is recited in the alternative with part (a)(ii), wherein part (ii) recites “a non-transgenic progeny or descendant of line GM40 or GM1606.” Since claim 94 limits the scope of part (a)(i), it is interpreted as not being directed to the “progeny or descendant” recited in part (a)(ii). However, as set forth in the obviousness rejection below, the prior art will make obvious a plant comprising at least two copies of SEQ ID NO: 2, thus reading directly on the plant of claim 94 (as well as the plant of claim 86).
Claim Rejections - 35 USC § 103
15. 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.
16. Claims 12, 15, 86-88, 92, 93, 94, 96, 98, and 101 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 December 16, 2025 were fully considered but they are not persuasive.
The claims are drawn to a sunflower plant of lines GM40 or GM1606, or their progeny or descendant of said lines, wherein said progeny, or descendant comprises SEQ ID NO: 2 and the herbicide-resistance characteristics of line GM40 or GM1606. The claims are drawn to a seed of said sunflower plant, wherein said seed comprises the herbicide resistance characteristics of said lines.
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 obtained by EMS mutagenesis followed by imidazolinone selection pressure (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 (Jander et al, pg. 7, paragraph 68).
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 imidazolinone 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 sunflower AHASL (such as the one represented by 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, for example. Given that the only difference between the instant SEQ ID NO: 2 and the wild-type AHASL of Kolkman et al is the presence of the alanine at relative position 122, the resultant mutant AHASL would comprise a polypeptide identical to the full-length SEQ ID NO: 2. It would have been further obvious to obtain the seeds of said plants, wherein the seeds comprise said substitution, as a matter of standard industry practice, given that sunflower is a seed crop.
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, it would have been prima facie obvious to introduce the mutant AHASL1 gene encoding the protein with the A107T substitution (including wherein the gene is from Arabidopsis, as taught by Jander et al) into a sunflower plant, as expressly taught by Jander et al. The resultant plant would read on the “transgenic” progeny of the plants of lines GM40 and GM1606, and would comprise the full-length SEQ ID NO: 2.
Given the teachings of Kolkman et al regarding the introgression of mutant AHASL into elite lines, it would have been obvious to obtain elite lines comprising said mutant AHASL. Sine elite lines are true breeding, the resultant plants would be homozygous for the mutant and thus comprise at least two copies of the gene.
The tolerance to specific application rates would not have been unexpected given that the A122T substitution results in resistance to imidazolinone herbicides, including imazapyr, as taught by Jander et al, for example. Moreover, in view of said resistance conferred by the A122T substitution, one would reasonably expect that at least some plants treated with imazapyr would show biomass or height comparable to that of untreated control. In addition, the properties conferred by the presence of the A122T would have naturally flowed from the structure of said plant, which structure would have been prima facie obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
It would have been obvious to apply an imidazolinone herbicide, including in a liquid formulation, to the resultant sunflower plant either to confirm the tolerance or in an standard method of weed control, such as those taught by Jander et al. Given that the A122T substitution confers resistance to imidazolinones, at least a portion of at least some plants would show “no injury” from said herbicide, and said plants would show less injury than a wild-type control. Moreover, a field in which said sunflower plant and weeds were treated with an herbicide would read on the field of claims 96 and 98.
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 their invention to practice, given the limited number of known 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.
17. Claims 82 and 83 remain rejected under 35 U.S.C. 103(a) as being unpatentable over Jander et al (US Application No. 2003/097692 A1, published May 22, 2003), 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 12, above, and further view of Garcia-Torres et al (Weed Res. (1994) 34: 395-402). Applicant's arguments filed on December 16, 2025 were fully considered but they are not persuasive.
The claims are drawn to a seed of the plant of claim 12, wherein the seed is treated with an AHAS-inhibiting herbicide. The teachings of Jander et al, Kolkman et al, and Kmiec et al are set forth above. The references do not teach treating a seed with an AHAS inhibiting herbicide.
Garcia-Torres et al teach pre-emergent application of imazethapyr, imazapyr, and chlorsulfuron in sunflower to control broomrape, a parasitic plant (Garcia-Torres et al, Abstract).
At the time the invention was made, it would have been prima facie obvious to modify the seeds made obvious by the teachings of Jander et al, Kolkman et al, and Kmiec et al and by coating them with any appropriate AHAS inhibitor herbicides, including those taught by Garcia-Torres. One would have been motivated to do so in order to protect the sunflower seeds, pre-emergence, from broomrape, a common sunflower parasite.
18. Claim 95 remains 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 12, and further in view of Flanagan et al (US Patent Publication 2005/0138685, priority to December 22, 2003). Applicant's arguments filed on December 16, 2025 were fully considered but they are not persuasive.
The claim is directed to the sunflower plant of claim 12, further comprising a polynucleotide that encodes polypeptides having at least one of pesticidal activity or insecticidal activity.
The teachings of Jander et al, Kolkman et al, and Kmiec are set forth above. The references do not expressly teach a sunflower plant comprising a mutant AHAS and polynucleotide encoding a pesticidal protein.
Flanagan et al teach endotoxins obtained from B. thuringiensis, expression cassettes comprising nucleic acids encoding said toxins, and teach compositions and plants comprising said nucleic acids (claims 1-4 and 9-12). Flanagan et al teach stacking the nucleic acids encoding said endotoxins with nucleic acids encoding herbicide tolerance genes, including AHAS mutants (syn. “acetolactate synthase”) (paragraph 0156).
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 sunflower plant made obvious by the combined teachings of Jander et al Kolkman et al, and Kmiec et al using the teachings of Flanagan et al, and stack the nucleic acid encoding said mutant AHAS with a nucleic acid encoding any of the Cry proteins taught by Flanagan et al. It would have been obvious to express the resultant nucleic acid in a plant or a cell.
The resultant plant would read on the plant of claim 95. One would have been motivated to combine said teachings to impart insecticidal and herbicidal tolerance to a sunflower plant. Given the routine nature of the methods involved, and the fact that Flanagan et al reduced their invention to practice, one would have had reasonable expectation of success.
19. Claim 100 remains 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 12 and 96-99, and further in view of Kaya et al (Helia (2004) 27:199-210). Applicant's arguments filed on December 16, 2025 were fully considered but they are not persuasive.
The claim is drawn to the field of claim 96, wherein one or more weeds is of the genus Sinapis or the other recited genera.
The teachings of Jander et al, Kolkman et al, Kmiec et al are set forth above. The references do not teach weeds of the genus Sinapis.
Kaya et al teach that Sinapis arvensis is an important weed of the cultivated sunflower, and that it can be successfully controlled with imidazolinones (pages 200 and 202).
At the time of filing, it would have been prima facie obvious to further modify the teachings of Jander et al, Kolkman et al, Kmiec et al and apply, in a field comprising the herbicide tolerant sunflower plant, an imidazolinone herbicide to said plant as well as to any of its common weeds such as the wild mustard taught by Kaya et al, in order to control said weeds. The resultant field would read on the instant invention.
Response to Arguments
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).
With regard to the dependent claims 82-83, 95, and 100, Applicant argues that “the combination of Jander, Kolkman, and Kmiec does not render obvious any of the claims” and the additional references do not overcome the deficiencies of said combination (page 10 of the Remarks).
Applicant’s arguments are not found to be persuasive. 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.
Applicant’s previously submitted arguments were addressed in detail in the previous Office Action and remain not persuasive for the reasons of record. This includes the argument based on Pfizer and the other legal precedent previously cited by Applicant (see, for example, Non-Final Office Actions mailed on May 7, 2024 and December 30, 2021).
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Examiner maintains that in the instant case, there is no dispute that Jander does not expressly teach a “non-transgenic” sunflower comprising the A122T substitution in the endogenous AHASL gene. This, however, does not make the argument persuasive because such plant would have been prima facie obvious in view of the combined teachings of the cited art, as set forth in the rejection above.
Regarding the teachings of Jander being “hypothetical,” Applicant has submitted no factual evidence that the invention of Jander or the teachings for which the reference is cited in the rejection are not-enabled. The Examiner maintains that the tense of illustrative Examples 2-4 of Jander cannot be relied upon to support Applicant’s previously submitted argument that “Jander does not … provide an enabling disclosure for producing such a sunflower plant.” This is because at the time of invention, multiple methods of introducing a mutation into a known gene of a dicot plant such as sunflower, including EMS mutagenesis with herbicide pressure and selection, and the method of Kmiec. Moreover, the Jander reference was not relied upon for the express disclosure of a “non-transgenic” sunflower comprising the A122T substitution. However, the suggestion in Kolkman of introducing the (exogenous) AHASL comprising the A122T substitution into a sunflower plant would have contributed to the motivation of arriving at the instant invention.
With regard to the teachings of Kmiec, contrary to Applicant’s position, the reference expressly suggests Applying the methods of their invention to sunflower (paragraph 19). Designing an oligonucleotide to introduce the A122T substitution into sunflower would have been obvious in view of the teachings of Kmiec and sequence information for the sunflower AHASL, which was also known in the prior art.
In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, including the argument directed to the teachings of Kolkman, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In the instant case, no knowledge was gleaned only from Applicant’s disclosure. For example, the fact that the instant SEQ ID NO: 2 must be searched and compared to the prior art does not change the position that one would have been able to rely on the sequence information of Kolkman to introduce the A122T substitution into the sunflower AHASL without any knowledge from the instant disclosure.
Applicant’s argument directed to the lines GM40 and GM1606 and their properties is not persuasive because it is not commensurate with the scope of the claims, which encompass any “non-transgenic” progeny or descendant, of any filial generation, comprising the characteristics of said lines. A sunflower plant comprising a sequence that reads on the instant SEQ ID NO:2 and having the having the resistance characteristics conferred by the A107T substitution, will read on said progeny or descendant. See MPEP 716.02.
Further, the Examiner maintains that the motivation to select sunflower for introduction of the A107T substitution would have been derived from the desirability of an imidazolinone tolerant sunflower plant (see Kolkman et al), and given the express suggestion of Jander et al to introduce an AHASL1 comprising the A107T substitution into sunflower. The fact that other substitutions such as those taught by Kolkman et al may also confer imidazolinone tolerance would not have taught away from the instant invention. The Examiner maintains that the tolerance to said two herbicides would not be unexpected given that the A107T substitution is well-known to result in tolerance to imidazolinone herbicides, as taught by Jander et al, for example. For this reason, Applicant’s argument directed to the teachings of Kmiec et and the lack of motivation is not found to be persuasive.
In addition, contrary to Applicant’s position, all cited prior art is directly relevant to the “field of endeavor” of the instant invention. This includes the methods of Kmiec et al and Jander et al. Using either method in combination with the teachings of Kolkman et al as well Jander et al, one of ordinary skill in the art would have been able to predictably arrive at a sunflower plant whose structure would read on that of the sunflower plant of the instant claim 12. The product-by-process language “said gene being free of any product of site-directed mutagenesis,” in addition to rendering the claim indefinite, as set forth above, does not affect the structure, and therefore, the patentability, of “said gene” which structure is determined by its sequence of nucleotides not method of production. See MPEP 2113.
The Examiner maintains that the only difference between the instant SEQ ID NO: 2 and a wild-type sunflower AHASL protein is the presence of the A107T substitution. The substitution was well-characterized in the art at the time of filing. Jander et al successfully used the EMS mutagenesis/herbicide pressure method to introduce said substitution intro 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. The rejection is maintained.
Conclusion
20. No claims are allowed.
21. 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