DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Status of the Application
2. Claims 23-27, 40, 41, 43, 45-47, and 49-55 are pending.
3. Claims 23-27, 40, 41, 43, 45-47, and 49-55 are examined herein.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 16, 2026 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. Claim 55 remains and claims 23-27, 40, 41, 43, 45-47, and 49-54 are 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 claim. Applicant’s argument submitted on July 16, 2026 was fully considered but it is not persuasive.
In claim 23, the phrase “each allele being free of products of directed mutagenesis” renders the claim indefinite. Each of the two recited mutant AHASL1 alleles is defined by its nucleotide sequence. It is thus unclear what the term “products” refers to or how said sequences are meant to be free from it. The specification does not recite any such “products” and fails to clarify the meaning of the term in the context of the above phrase. Given that claims 24-27, 40, 41, 43, 45-47, and 49-54 depend from claim 23 and fail to recite additional limitations overcoming its indefiniteness, these dependent claims are indefinite as well.
Claim 55, as instantly amended, recites the following clause: “wherein a plant grown from the seed, upon expressing said first and second AHASL1 proteins, possesses a phenotype of tolerance comprising a phytotoxicity, at 21 days after treatment, that is within the range of the phytotoxicities of a group of sunflower plants that have homozygous A122T/A122T alleles and that together have an average phytotoxicity of from 3-5% from 200 g/AI/ha imazamox at 21 days after treatment.” This clause renders the claim indefinite.
It is unclear how the term “phytotoxicity” would apply to a single sunflower plant recited in said “wherein” clause, given that the “range of 3-5%” and “average phytotoxicity” 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 the phytotoxicities … of 3-5%” means. For example, it 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%.” The metes and bounds of the claim are thus unclear.
Response to Arguments
Applicant argues that the amendments to the claims overcome the rejection (page 5 of the Remarks). This is not found to be persuasive. While Applicant’s amendments are acknowledged and the rejection has been modified accordingly, the metes and bounds of the claims remain and are unclear for the reasons set forth above.
Claim Interpretation
7. The following is noted with regard to claim interpretation. With regard to the limitation “herbicide resistance characteristics of a sunflower plant that is homozygous for the first allele,” in claim 23, the term “first allele” refers to the A122T allele. Neither the specification nor the claims clarify what is encompassed by said “characteristics.” At the same time, the specification indicates that the tolerance profiles to imidazolinones for the A122T/A122T homozygous plants differ from those for the A122T/A205V heterozygous ones (see, for example, Fig. 1-3 and 10-12). Therefore, the term “characteristics” is given its broadest reasonable interpretation as meaning higher tolerance to an imidazolinone than that of a wild-type plant.
Claim 23 recites “wherein said first allele is an allele of the AHASL gene of line GM40 or GM1660.” The specification teaches that the herbicide tolerance allele present in said two lines is the A122T mutant AHASL (see page 15, lines 14-33). Said limitation thus does not introduce any further structural limitations to said allele beyond the substitution expressly recited in the “wherein” clause in line 3 of the claim.
In the instant amendments, Applicant added the following limitation to claim 23: “each allele being free of products of directed mutagenesis.” As set forth below, the limitation renders the claim indefinite. For the purpose of the examination, it is interpreted as a product-by-process limitation as not affecting the nucleotide sequence of the two endogenous mutant AHASL alleles. See MPEP 2113.
Claims 24 and 25 require that the claimed seed be a descendant of lines GM40 or GM1606. The claims, however, do not limit said descendant by a filial generation or by any characteristics other than the presence of the two mutant AHASL1 alleles recited in claim 23. As a result, claims 24 and 25, as well as 23, will encompass any sunflower seed comprising said alleles and having at least about 85% oleic acid. It is noted that the only herbicide resistance characteristics described for lines GM40 and GM1606 are those conferred by the presence of the A107T substitution. In claim 49, the limitation “about 85.79% to about 88.97% oleic acid,” due to the use of the term “about” is read as comprising a range that will encompass 85%.
Claim 55, as instantly amended, recites the following limitation: “possesses a phenotype of tolerance comprising a phytotoxicity, at 21 days after treatment, within the rage of the phytotoxicities of sunflower plant that have homozygous A122T/A122T alleles and that together have an average phytotoxicity of 3-5% from 200 g AI/ha imazamox at 21 days after treatment.” This property is inherent in a plant that has the alleles with the recited mutations. 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” (page 49 of the specification). See also page 56 where the specification teaches that said phytotoxicities were equivalent at 21 DAT. Therefore, the evidence in the record shows that if the plant comprises the claimed heterozygous alleles, the recited phenotype will be inherently present in said plant.
Claim Rejections - 35 USC § 103
8. 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.
9. Claims 23-27, 40, 41, 43, 49, and 50-55 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), Kmiec et al (U.S. Patent Application No. 2003/0236208 A1, published December 25, 2003), and Fernandez-Martinez et al (Euphytica (1989) 41:39-51). This rejection has been modified in view of Applicant’s amendments to the claim. Applicant's argument submitted on July 16, 2026 has been fully considered but it is not persuasive.
The claims are drawn to a non-transgenic sunflower seed comprising a first AHASL1 allele encoding a first AHASL1 protein comprising an alanine to threonine substitution at a position corresponding to position 7 of SEQ ID NO: 20, and a second allele of said AHASL1 gene, encoding a second AHASL1 protein comprising an alanine to valine substitution at the position corresponding to position 90 of SEQ ID NO: 20, wherein said seed produces extractable seed oil with “at least about” 85% oleic acid or comprises extractable seed oil comprising “about 85.79% to about 88.97%” oleic acid; wherein a plant grown from the seed comprises the herbicide resistance characteristics of a sunflower plant that is homozygous for the first allele; including wherein the sunflower seed is a descendant of a sunflower plant line GM40 or GM1606. The claims are drawn to a method for controlling weeds comprising the use of said seed.
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 (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 that the A122T substitution confers resistance to imidazolinones but not sulfonylureas (paragraph 0017; 0025). Jander et al teach applying imidazolinones by spraying it in a liquid preparation comprising a solvent and a surfactant, which preparation would read on “wet preparation” or “liquid concentrate” recited in claims 51 and 52, as well as new claims 53 and 54 (paragraph 0075).
Jander et al do not teach a sunflower seed comprising an AHASL1 allele encoding and AHASL1 protein with the A107T substitution and having at least 85% oleic acid content.
Kolkman et al teach a sunflower plant comprising at least one copy of an AHASL1 polynucleotide encoding an herbicide resistance AHASL1 protein (Fig. 2 on pg. 1152). Kolkman et al teach that a proline to leucine mutation at position 182 (P197L in the Arabidopsis numbering) and an alanine to valine mutation at position 190 (A205V in the Arabidopsis numbering) of AHASL1 confer resistance to imidazolinone and sulfonylurea herbicides, such as imazethapyr and chlorimuron (pg. 1153, right col; pg. 1157). Kolkman et al teach that the A205V substation in AHASL1 is partially dominant and does not confer complete tolerance to imidazolinones (paragraph spanning pg. 1157 and 1158). Kolkman et al teach plants that are heterozygous for the mutation (pg. 1155, both col.; pg. 1156, left col.; pg. 1157, right col.).
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 has 99.8% sequence identity to the instant SEQ ID NO: 20. The instant specification defines SEQ ID NO: 20 as truncated sunflower AHASL with the A107T substitution (see pg. 11). 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. 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).
CC -!- CATALYTIC ACTIVITY: 2 pyruvate = 2-acetolactate + CO(2).
CC {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.
CC {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
CC from pyruvate: step 1/4. {ECO:0000256|RuleBase:RU003591}.
CC -!- SIMILARITY: Belongs to the TPP enzyme family.
CC {ECO:0000256|RuleBase:RU362132}.
CC -----------------------------------------------------------------------
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DR EMBL; AY541451; AAT07322.1; -; Genomic_DNA.
DR ProteinModelPortal; Q5VB49; -.
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 InterPro; IPR012846; Acetolactate_synth_lsu.
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
KW {ECO:0000256|RuleBase:RU003591};
KW Magnesium {ECO:0000256|RuleBase:RU003591};
KW Metal-binding {ECO:0000256|RuleBase:RU003591};
KW Thiamine pyrophosphate {ECO:0000256|RuleBase:RU362132};
KW Transferase {ECO:0000256|RuleBase:RU003591,
KW ECO:0000313|EMBL:AAT07322.1}.
FT DOMAIN 83 247 TPP_enzyme_N. {ECO:0000259|Pfam:PF02776}.
FT DOMAIN 275 407 TPP_enzyme_M. {ECO:0000259|Pfam:PF00205}.
FT DOMAIN 469 624 TPP_enzyme_C. {ECO:0000259|Pfam:PF02775}.
SQ SEQUENCE 655 AA; 71322 MW; 3AF7DF2D81C31752 CRC64;
Query Match 99.8%; Score 2026; DB 40; 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: 20, and also makes obvious the genus of nucleic acid sequences 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).
Fernandez-Martinez et al teach sunflower lines that are true breeding for high oleic acid content (average of higher than 85%, including 94%) (Abstract; pg. 41, both col.).
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 any sunflower plant, including a sunflower plant whose seeds have oleic acid content of 85% or higher, such as the plants of Fernandez-Martinez.
It would have been obvious to use the introgression methods taught by Kolkman et al, and to cross the resultant sunflower plants comprising the A107T mutation with a sunflower plant comprising the A190V substitution, as taught by Kolkman et al, thus obtaining sunflower plants comprising these two mutations on different AHASL1 alleles, and thus heterozygous for each mutation. The resultant sunflower would comprise the endogenous AHASL alleles encoding said mutant AHASL proteins and will thus be considered “non-transgenic.”
The phenotype of tolerance to an imidazolinone herbicide of a sunflower plant grown from said resultant seed would not have been unexpected given the known properties of the A122T and the A205V substitutions, as taught by Jander and Kolkman et al. In addition, “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). MPEP 2145.
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, wherein the herbicide is applied to the resistant sunflower plant and the weeds, as suggested by Jander and as a matter of routine industry practice. Obtaining the seeds of said plants would have been obvious given that sunflower is a seed crop.
Given the teachings of Kmiec et al and Jander et al, and given the routine nature of the introgression methods of Kolkman et al, one would have had reasonable expectation of success in obtaining said plants comprising two AHASL1 alleles each comprising a different herbicide resistance mutation.
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 both, sulfonylureas and imidazolinones, and having high oleic acid content. One would have been also motivated to cross two sunflower plants comprising the A107T substitution in the AHASL1 with a plant comprising the A205V substitution given the teachings of Kolkman.
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, followed by a routine breeding method, including that taught by Kolkman et al to arrive at the instant invention.
10. Claims 45-47 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), Kmiec et al (U.S. Patent Application No. 2003/0236208 A1, published December 25, 2003), and Fernandez-Martinez et al (Euphytica (1989) 41:39-51), as applied to claim 23, and further in view of Garcia-Torres et al (Weed Technology (1995) 9:819-824). Applicant's argument submitted on July 16, 2026 has been fully considered but it is not persuasive.
The claims are directed to the sunflower seed of claim 23, further comprising an effective amount of an AHAS inhibiting herbicide, including an imidazolinone, on the surface.
The teachings of Jander et al, Kolkman et al, Kmiec et al, and Fernandez-Martinez et al are set forth above. The references do not expressly teach a sunflower seed comprising a herbicide coating.
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, Fernandez-Martinez et al, and Kmiec et al by coating them with any appropriate AHAS inhibitor herbicide, 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.
Response to Arguments
Applicant argues as follows: “The U.S. produces agricultural products (e.g., seeds and plants) exported to many other countries in the world. Two given seeds or plants produced by different manners of making are not fungible in the real world because: (i) agricultural products require regulatory approvals that maintain with each product its manner of making; (ii) the agriculture industry comprises three distinct product segments defined solely by their three different manners of making: traditional/mutagenized products ("Trad"), transgenic products ("GM"), and genome-edited-site-directed mutagenesis-products ("GE"); and (iii) different countries differently regulate, restrict, permit and/or ban importation, sales, and growing of products of each of these three product types based solely on their manner-of-making. Specifically, products belonging to these three agricultural product segments are treated differently (i) in where they can be grown and to where they can be exported from the U.S. (both significantly limiting the markets available to a U.S. seed producer), and (ii) in how they must be labeled in import countries. …. In addition, many jurisdictions ban import and/or prohibit growing of GM and/or GE products-based on their manner of making-unless and until the jurisdiction's regulatory authority has first granted approval of the product, following a thorough, 4+ year review of a dossier of data establishing the manner of making and the characterization of field performance, product properties, and environmental and health risks of each product. Because of these real-world differences between the three manner-of-making agricultural product segments, a seed or plant containing the same gene variants-made by traditional/mutagenized, GM, or GE techniques-and with no difference in morphology or molecular structure are not identical products in the real world strictly and only because of their method of making.
Claim 23's recitation of "non-transgenic" and "free of products of directed mutagenesis" serve to define the sunflower seed as belonging to the third agricultural product category- traditional/mutagenized products segment. These recitations are substantive claim elements because they give meaning and purpose to the claim as they provide (i) the identity of the product; (ii) the product's range of uses in the agriculture industry; and (iii) the cluster of available target markets for the product” (pages 5-6 of the Remarks).
Applicant’s argument is not found to be persuasive. Whether a sunflower plant comprising the nucleic acid molecule of the instant claims is classified in one regulatory category or another, or whether it would be amenable to regulatory approval or commercialization in certain countries is irrelevant to the instant prima facie finding of obviousness. It is noted that Applicant cited no legal authority in support of the above argument and established no structural differences between the non-transgenic sunflower seed of the instant claims and the sunflower seed that would have been made prima facie obvious by the teachings of the prior art.
The fact that a regulatory body may consider two seeds or plants “with no difference in morphology or molecular structure” to be “not identical products in the real world” is irrelevant to the patentability: if one of those identical seeds or plants is claimed and the other one is disclosed or made obvious by the prior art, the first plant will not be patentable, under the U.S. statutes. In the instant case, a sunflower plant comprising an endogenous AHASL1 nucleic acid that is indistinguishable from the plant and nucleic acid of the instant claims would have been made prima facie obvious by the teachings of the prior art.
It is noted that “The fact that a combination would not be made by businessmen for economic reasons does not mean that a person of ordinary skill in the art would not make the combination because of some technological incompatibility.” In re Farrenkopf, 713 F.2d 714, 219 USPQ 1 (Fed. Cir. 1983).
Applicant’s previously submitted arguments were considered in detail in the previous Office Actions and remain unpersuasive for the reasons of record. This includes the arguments based on the property of herbicide tolerance, the cited legal opinions, and those based on Dr. Mankin’s Declaration.
The Examiner maintains that a property may make a product non-obvious. This rule, however, requires an evidentiary showing that the property at issue is, in fact, unexpected. This is because any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 716.02. The Examiner maintains the phenotype of tolerance to an imidazolinone herbicide of a sunflower plant grown from the prima facie obvious mutant sunflower seed would not have been unexpected given the known properties of the A122T and the A205V substitutions, as taught by Jander and Kolkman et al. For that reason, Applicant has not established that the recited property would have been unexpected.
The Examiner maintains that the instant invention amounts to combining two alleles each encoding an AHASL with an individual substitution, in the same sunflower plant. Both substitutions at issue were well-known in the art at the time of invention, as were the herbicide tolerance properties they confer. The conserved nature of the domains in which they are located was well-recognized as well. Both the methods for predictably introducing said substitutions into the AHASL of a sunflower plant and the motivation to do so were also taught in the prior art. The rejection is maintained.
Conclusion
11. No claims are allowed.
12. 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.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to whose telephone number is (571)272-6921. The examiner can normally be reached Mon.-Fri. 9:00-5:30 PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BRATISLAV STANKOVIC can be reached at (571)270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
14. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MYKOLA V. KOVALENKO/Primary Examiner, Art Unit 1662
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