DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/13/2026 has been entered.
Status of the Claims
Claims 3-8, 10, 12, 16-17, and 25-31 are canceled.
Claims 1-2, 9, 11, 13-15, 18-24, and 32-34 are pending.
Claims 1-2, 9, 11, 13-15, 18-24, and 32-34 are examined herein.
Claims 1, 2, 9, 11, and 32-34 are allowed.
Claims, 13-15 and 18-24 are rejected.
Priority
Application No. 18/465,595 filed on 09/12/2023 is a continuation of Application
No. 17/404,842 filed on 08/17/2021, which is a continuation of Application No.
15/802,397 filed on 11/02/2017, which is a divisional of Application No. 14/118,491 filed
on 06/20/2014, which is a 371 of PCT Application No. PCT/US12/38719 filed on
05/18/2012, which claims priority to provisional Application No. 61/488,592 filed on
05/20/2011.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 13-15 and 18-24 are rejected under 35 U.S.C. 102 (a) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Khanna (WO-2009117448-A1, published 09/24/2009).
Claim 13 is drawn to a transgenic plant produced by the method of claim 1, wherein the transgenic plant comprises the at least one recombinant polynucleotide.
Claim 14 is drawn to the transgenic plant of claim 13, wherein the transgenic plant is a monocot, dicot or a conifer.
Claim 15 is drawn to the transgenic plant of claim 14, wherein the dicot or conifer is a: member of the family Pinaceae, cedar plant, fir plant, hemlock plant, larch plant, pine plant, spruce plant, member of the family Amaranthaceae, spinach plant, member of the family Anacardiaceae, mango plant, member of the family Asteraceae, sunflower plant, endive plant, lettuce plant, artichoke plant, member of the family Brassicaceae, Arabidopsis thaliana plant, rape plant, oilseed rape plant, broccoli plant, Brussels sprouts plant, cabbage plant, canola plant, cauliflower plant, kohlrabi plant, turnip plant, radish plant, member of the family Bromeliaceae, pineapple plant, member of the family Caricaceae, papaya plant, member of the family Chenopodiaceae, beet plant, member of the family Curcurbitaceae, melon plant, cantaloupe plant, squash plant, watermelon plant, honeydew plant, cucumber plant, pumpkin plant, member of the family Dioscoreaceae, yam plant, member of the family Ericaceae, blueberry plant, member of the family Euphorbiaceae, cassava plant, member of the family Fabaceae, alfalfa plant, clover plant, peanut plant, member of the family Grossulariaceae, currant plant, member of the family Juglandaceae, walnut plant, member of the family Lamiaceae, mint plant, member of the family Lauraceae, avocado plant, member of the family Leguminosae, soybean plant, bean plant, pea plant, member of the family Malvaceae, cotton plant, member of the family Marantaceae, arrowroot plant, member of the family Myrtaceae, guava plant, eucalyptus plant, member of the family Rosaceae, peach plant, apple plant, cherry plant, plum plant, pear plant, prune plant, blackberry plant, raspberry plant, strawberry plant, member of the family Rubiaceae, coffee plant, member of the family Rutaceae, citrus plant, orange plant, lemon plant, grapefruit plant, tangerine plant, member of the familySalicaceae, poplar plant, willow plant, member of the family Solanaceae, potato plant, sweet potato plant, tomato plant, Capsicum plant, tobacco plant, tomatillo plant, eggplant plant, Atropa belladona plant, Datura stramonium plant, member of the family Vitaceae, grape plant, member of the family Umbelliferae, carrot plant and/or member of the family Musaceae, banana plant, or wherein the monocot is a: member of the family Poaceae; maize plant; rice plant; wild rice plant, wheat plant; barley plant; sorghum plant; rye plant; oat plant; millet plant; turfgrass plant; sugarcane plant, bamboo plant, brome-grass plant, pampas grass plant, Miscanthus plant; switchgrass plant, teosinte plant; and/or member of the family Alliaceae, onion, leak and garlic.
Claim 18 is drawn to a tissue culture produced from protoplasts or cells from the transgenic plant of claim 13, wherein said cells or protoplasts are produced from a plant part selected from the group consisting of leaf, pollen, ovule, embryo, cotyledon, hypocotyl, meristematic cell, root, root tip, pistil, anther, flower, seed, shoot, stem, pod and petiole.
Claim 19 is drawn to a regenerated plant regenerated from the tissue culture of claim 18.
Claim 20 is drawn to a seed from the transgenic plant of claim 13.
Claim 21 is drawn to a method for producing a transgenic seed, the method comprising crossing two plants and harvesting resultant seed, wherein at least one plant is the transgenic plant of claim 13.
Claim 22 is drawn to a transgenic seed from the selected transgenic plant produced by the method of claim 1, wherein the transgenic seed comprises the at least one recombinant polynucleotide.
Claim 23 is drawn to a transgenic progeny plant, or a part thereof, produced by growing the seed of claim 22.
Claim 24 is drawn to the transgenic progeny plant of claim 23, wherein the transgenic progeny plant comprises the at least one recombinant polynucleotide and has increased yield as compared to a control plant.
Regarding claim 13, Khanna discloses overexpressing SEQ ID NO: 32, which is 100% identical to instant SEQ ID NO: 530, in transgenic plants wherein SEQ ID NO: 32 is operably linked to a 35S heterologous promoter (p. 38-40, Table 5).
Regarding claim 14-15, Khanna discloses the transgenic plant is Arabidopsis (p. 39, lines 17-20, Tables 6-7 and caption).
Regarding claims 18-19, Khanna discloses germination assays on the seed produced from the transgenic plant are performed in tissue culture (p. 43, line 4), and the sterile seeds are sown on media, incubated in growth chambers, and evaluation of germination and seedling vigor is performed five days after planting (p. 43, lines 17-20) (i.e. the seed is in tissue culture and then is regenerated into a seedling/plant).
Regarding claim 20, Khanna discloses the transgenic plant is produced from a floral dip method, and the plant from the T0 seed is grown to seed set and the seeds are analyzed (p. 40, lines 6-9 and 32-36, and p. 41, line 1).
Regarding claim 21, as state above Khanna discloses a structurally identical plant as claimed in instant claim 13 that is a transgenic plant overexpressing SEQ ID NO: 32, which is 100% identical to instant SEQ ID NO: 530, operably linked to a 35S heterologous promoter (p. 38-40, Table 5). Khanna also discloses after a plant or plant cell is transformed (and the latter regenerated into a plant), the transformed plant may be crossed with itself or a plant from the same line, a non -transformed or wild- type plant, or another transformed plant from a different transgenic line of plants (p. 54, lines 4-7). Khanna discloses crossing provides the advantages of producing new and often stable transgenic varieties (p. 54, lines 4-7).
Regarding claim 22, Khanna discloses producing a transgenic plant with a 35S promoter driving expression of a sequence identical to instant SEQ ID NO: 530 via floral dip method and growing the plants to seed set, and the seed morphology is assessed on selection plates (i.e. at least some of the seed is transgenic) (p. 41, line 1).
Regarding claim 23, Khanna discloses seed morphology is assessed on selection plates (i.e. at least some of the seed is transgenic) (p. 41, line 1). Therefore, Khanna discloses growing a progeny plant from seed collected from the transgenic plant.
Regarding claim 24, as stated above, Khanna discloses seed morphology is assessed on selection plates (i.e. because Khanna is using selection plates to select for the transgenic seed, it is reasonably interpreted that at least some of the seed is transgenic) (p. 41, line 1). Furthermore, because the plant is structurally identical to the instantly claimed plant, it is reasonably interpreted to have the trait of increased yield as compared to a control plant as a function of inherency.
The disclosures of Khanna appear to anticipate the rejected claims, however, in the alternative, Claims 13-15 and 18-24 are obvious in view of Khanna. Based on the above teachings, the product that is the plant produced by the method of claim 1 is structurally identical to the plant disclosed by Khanna. The MPEP states "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)” (MPEP 2113.I). Therefore, even though Khanna does not teach the method step in claim 1 that is selecting the transgenic plant for having an increased yield of at least 6.1% as compared to a control plant (rendering the method claims allowable), the transgenic plant produced by the method of claim 1 (the products of claims 13-15 and 20-24) is the same as the plant in the prior art and is therefore unpatentable. Furthermore, some subset of the plants rendered anticipated/obvious are going to inherently have the increased yield characteristic claimed by the Applicant as claimed in Claim 24, therefore a transgenic plant produced ultimately by the method of claim 1 is also obvious in view of the prior art. For these reasons, the product of the claimed plant in claims 13-15 and 18-24 is anticipated, or in the alternative is obvious, in view of Khanna.
Alignments
Alignment of instant SEQ ID NO: 530 with SEQ ID NO: 32 of Khanna:
RESULT 1
AXR16058
(NOTE: this sequence has 5 duplicates in the database searched.
See complete list at the end of this report)
ID AXR16058 standard; protein; 241 AA.
XX
AC AXR16058;
XX
DT 19-JAN-2012 (revised)
DT 26-NOV-2009 (first entry)
XX
DE Plant Stress tolerance related protein sequence, SEQ ID 32.
XX
KW abiotic stress tolerance; cold tolerance; crop improvement;
KW drought resistance; gene silencing; heat tolerance; plant;
KW plant breeding; salt tolerance; seed yield increasing; stress tolerance;
KW transgenic plant.
XX
OS Glycine max.
XX
CC PN WO2009117448-A1.
XX
CC PD 24-SEP-2009.
XX
CC PF 17-MAR-2009; 2009WO-US037439.
XX
PR 18-MAR-2008; 2008US-0069929P.
XX
CC PA (MEND-) MENDEL BIOTECHNOLOGY INC.
XX
CC PI Khanna R, Ratcliffe O, Reuber TL;
XX
DR WPI; 2009-N90395/65.
DR N-PSDB; AXR16057.
DR PC:NCBI; gi347666424.
XX
CC PT New nucleic acid construct comprises genes regulating hypocotyl 5 (HY5),
CC PT salt tolerance homolog 2 (STH2), and constitutive photomorphogenic 1
CC PT (COP1), useful for developing transgenic plants with desired traits.
XX
CC PS Disclosure; SEQ ID NO 32; 88pp; English.
XX
CC The present invention relates to novel nucleic acid construct comprising
CC nucleic acid sequences regulating the expression of hypocotyl 5 (HY5),
CC salt tolerance homolog 2 (STH2), and constitutive photomorphogenic 1
CC (COP1), useful for developing transgenic plants with desired traits.
CC Altering the activity of specific regulatory proteins in plants involves
CC knocking down or knocking out HY5 clade or STH2 clade protein expression,
CC or by modifying COP 1 clade protein expression, where the HY5 clade
CC member polypeptide: is encoded by a polynucleotide that hybridizes to SEQ
CC ID NO: 2 (AXR16028) under stringent conditions; or comprises a V-P-E/D-f
CC -G domain having an amino acid identity to amino acids 35-47 of SEQ ID
CC NO: 2 (AXR16028), and a bZIP domain having an amino acid identity to
CC amino acids 78-157 of SEQ ID NO: 2 (AXR16028); or has an amino acid
CC identity to SEQ ID NO: 2 (AXR16028); and where the STH2 clade member
CC polypeptide: is encoded by a polynucleotide that hybridizes to SEQ ID NO:
CC 24 (AXR16050) under stringent conditions; or comprises two B-box domains
CC and the first B-box domain having an amino acid identity to amino acids 2
CC -33 of SEQ ID NO: 24 (AXR16050) and the second B-box domain having an
CC amino acid identity to amino acids 60-102 of SEQ ID NO: 24 (AXR16050); or
CC has an amino acid identity to SEQ ID NO: 24 (AXR16050); where
CC introduction of the nucleic acid construct into a plant results in
CC greater expression or activity of a COP1 clade member polypeptide in the
CC plant than in a control plant; where the COP1 clade member polypeptide:
CC is encoded by a polynucleotide that hybridizes to SEQ ID NO: 14
CC (AXR16040) under stringent conditions; or comprises a RING domain having
CC an amino acid identity to amino acids 51-93 of SEQ ID NO: 14 (AXR16040),
CC and a WD40 domain having an amino acid identity to amino acids 374-670 of
CC SEQ ID NO: 14 (AXR16040); or has an amino acid identity to SEQ ID NO: 2,
CC improves plant stress tolerance and plant yield. The construct is useful
CC for altering a trait in a plant and for developing transgenic plants with
CC desired traits, e.g. increased yield, increased germination, increased
CC seedling vigor, greater height of the mature plant, increased secondary
CC rooting, increased plant stand count, thicker stem, lodging resistance,
CC increased number of nodes, greater cold tolerance, greater tolerance to
CC water deprivation, reduced stomatal conductance, altered C/N sensing,
CC increased low nitrogen tolerance, increased tolerance to hyperosmotic
CC stress, delayed senescence, alteration in the levels of
CC photosynthetically active pigments, improved seed quality, reduced
CC percentage of hard seed, greater average stem diameter, increased stand
CC count, improved late season growth or vigor, increased number of pod-
CC bearing main-stem nodes, greater late season canopy coverage, or their
CC combinations, as compared to the control plant. The present sequence
CC represents Plant stress tolerance related protein sequence used in the
CC invention.
CC
CC Revised record issued on 15-JAN-2012 : Enhanced with precomputed
CC information from BOND.
XX
SQ Sequence 241 AA;
Query Match 100.0%; Score 1273; Length 241;
Best Local Similarity 100.0%;
Matches 241; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKGKTCELCDQQASLYCPSDSAFLCSDCDAAVHAANFLVARHLRRLLCSKCNRFAGFHIS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKGKTCELCDQQASLYCPSDSAFLCSDCDAAVHAANFLVARHLRRLLCSKCNRFAGFHIS 60
Qy 61 SGAISRHLSSTCSSCSPENPSADYSDSLPSSSTCVSSSESCSTKQIKVEKKRSWSGSSVT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SGAISRHLSSTCSSCSPENPSADYSDSLPSSSTCVSSSESCSTKQIKVEKKRSWSGSSVT 120
Qy 121 DDASPAAKKRQRSGGSEEVFEKWSREIGLGLGLGVNGNRVASNALSVCLGKWRWLPFRVA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 DDASPAAKKRQRSGGSEEVFEKWSREIGLGLGLGVNGNRVASNALSVCLGKWRWLPFRVA 180
Qy 181 AATSFWLGLRFCGDRGLASCQNLARLEAISGVPVKLILAAHGDLARVFTHRRELQEGWGE 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 AATSFWLGLRFCGDRGLASCQNLARLEAISGVPVKLILAAHGDLARVFTHRRELQEGWGE 240
Qy 241 S 241
|
Db 241 S 241
Closest Prior Art
Claims 1-2, 9, 11, and 32-34 appear free of the prior art.
Regarding claims 1-2, 9, 11, and 32-34 the closest prior art is Khanna (WO-2009117448-A1, published 09/24/2009). Khanna teaches expressing in transgenic plants a polypeptide sequence (SEQ ID NO: 32) that has 100% identity to instant SEQ ID NO: 530 wherein the gene expression is driven by a 35S promoter (p. 38, lines 5-12 and Table 5). Overexpression of SEQ ID NO: 32 of Khanna resulted in altered morphological and physiological traits, including reduced light response, in comparison to control plants (p. 48, lines 5-9 and Table 6). Khanna also teaches based on the beneficial effects of G1988 clade member overexpression on light response listed in table 6 (which includes SEQ ID NO: 32 of Khanna), it is expected that overexpression of G1988 clade member polypeptides will result in increased yield in commercial plant species (p. 48, lines 13-15) (i.e. the remaining limitations of claims 1 and 24). However, Khanna does not disclose, teach, or otherwise render obvious selecting the transgenic plant that overexpresses the polypeptide having at least 95% percentage identity to the amino acid sequence of SEQ ID NO:530 for having an increased yield of at least 6.1% as compared to a control plant.
Response to Arguments
Applicant argues beginning on p. 7 of remarks dated 02/13/2026 the
following arguments:
The Prior Art Contains No Actual Yield Data for SEO ID NO:530 (G4005)
The foundation of the rejection is the premise that because G1988 produced yield increases in field trials, it would be obvious that the phylogenetically related sequence G4005 (SEQ ID NO:530) would likewise produce yield increases meeting the claimed threshold of at least 6.1%. This premise fails at its inception because neither Khanna nor Creelman provides any actual yield data whatsoever for G4005 (SEQ ID NO:530).
Khanna is explicit on this point: yield measurements were never determined for G4005. In Table 6 of Khanna, the column for "Increased yield" shows "+3" for G1988, indicating that actual yield data were obtained, while G4005 shows "n/d," meaning the yield assay was "not performed" or "data not obtained." See Khanna at p. 48, Table 6; see also id. at p. 44 (defining "n/d" as "Experiment failed, data not obtained, or assay not performed"). Critically, the note accompanying Table 6 acknowledges that it is merely "expected" that overexpression of other G1988 clade member polypeptides will result in increased yield. See Khanna at p. 48, 11. 13-15. An expectation is not a teaching; it is speculation, and speculation cannot establish a reasonable expectation of success under 35 U.S.C. § 103.
Creelman fares no better: While Creelman extensively documents yield increases for G1988 transgenic soybean lines-reporting an average yield increase of 6.7% across multiple locations and some lines achieving 9-10% increases-these data are specific to G1988, not to G4005 (SEQ ID NO:530). See Creelman at [0037], [0269]-[0272], Tables 12-13, and Fig. 6. The Action cannot properly rely on yield data from one protein to establish a reasonable expectation of success for a structurally different protein absent evidence that the two proteins behave similarly in the relevant phenotypic characteristic. Such evidence is precisely what is absent from the cited prior art.
Creelman's Own Disclosure Demonstrates That G4005 Exhibits a Phenotype Distinct from G1988, Thereby Negating Any Reasonable Expectation of Success
Far from supporting the obviousness determination, the very document upon which the Action relies (Creelman) contains teachings that directly undermine any reasonable expectation of success. Creelman explicitly discloses that G4005 exhibited a different phenotypic response than G1988 when overexpressed. For example, Creelman at 1[0288] teaches "In experiments conducted thus far, overexpression of the soybean-derived homolog G4005, (SEQ ID NO: 6) did not cause long hypocotyls in the lines to be produced, but G4005 did confer other indications of an altered light response such as upright petioles and leaves." This is dispositive for the following reasons:
First, it establishes that different G1988 clade members do not produce identical phenotypic outcomes when overexpressed. G1988 produced elongated hypocotyls, a key marker of reduced light sensitivity in the Arabidopsis assay system used, while G4005 did not produce this hallmark phenotype. See Creelman at 1[0287]-[0288]; see also Khanna at p. 40, 11. 10-15 (describing long hypocotyls as indicative of reduced light sensitivity). The strength and character of phenotypic effects demonstrably vary among clade members, even those that are phylogenetically related.
Second, Creelman expressly links the light-response phenotype to yield improvement, stating that altered light signaling "may be a factor that can contribute to improved yield in G1988 clade-overexpressing plants." Creelman at 1[0240]. This teaching cuts directly against the Action's position. If G4005 produced a weaker light-response phenotype than G1988, as evidenced by the absence of long hypocotyls, then one of ordinary skill in the art would have had no reasonable basis to expect that G4005 would deliver comparable yield improvements. The prior art itself provides the evidence of unpredictability.
Third, this differential phenotypic response is entirely consistent with the unpredictability that characterizes the biotechnology field. As the MPEP acknowledges, "if the technology is unpredictable, it is less likely that structurally similar species will render a claimed species obvious because it may not be reasonable to infer that they would share similar properties." MPEP § 2144.08.II.A.4(e). The differing phenotypic profiles between G1988 and G4005, documented in Creelman itself, constitute direct, contemporaneous evidence of this unpredictability. Where the prior art itself teaches phenotypic divergence between two orthologs, obviousness cannot be established by mere phylogenetic similarity.
The Prior Art Discloses Substantial Variability in Yield Results, Even for G1988 Itself The Action's analysis oversimplifies the prior art by implying that overexpression of G1988 clade members reliably and predictably produces yield increases. Creelman's own data demonstrate precisely the opposite: substantial variability among transgenic lines, with some lines performing at or below control levels. In Table 12 of Creelman, lines 206 and 198 (which did not express G1988 to a significant level) actually showed yield decreases of -5.86 bushels/acre and - 2.88 bushels/acre, respectively. See Creelman at 1[0270], Table 12. More significantly, even Line 217, which did express G1988, albeit at a lower level than the high-yielding lines-showed a yield decrease of -2.69 bushels/acre. Id. Thus, even when transgene expression is confirmed, yield improvement is not guaranteed.
These data compel a straightforward conclusion: merely overexpressing a G1988 clade member does not guarantee yield improvements. The variability between lines-with some performing at or below control levels-is precisely why the claimed method requires a selection step for plants exhibiting at least a 6.1% yield increase. This selection step is not an obvious extension of the prior art teachings; it is a purposeful method step that identifies the specific, and necessarily limited, subset of transgenic plants that achieve the claimed performance threshold.
The Prior Art Discloses Substantial Variability in Yield Results, Even for G1988 Itself
The Action's analysis oversimplifies the prior art by implying that overexpression of G1988 clade members reliably and predictably produces yield increases. Creelman's own data demonstrate precisely the opposite: substantial variability among transgenic lines, with some lines performing at or below control levels. In Table 12 of Creelman, lines 206 and 198 (which did not express G1988 to a significant level) actually showed yield decreases of -5.86 bushels/acre and - 2.88 bushels/acre, respectively. See Creelman at 1[0270], Table 12. More significantly, even Line 217, which did express G1988, albeit at a lower level than the high-yielding lines-showed a yield decrease of -2.69 bushels/acre. Id. Thus, even when transgene expression is confirmed, yield improvement is not guaranteed.
These data compel a straightforward conclusion: merely overexpressing a G1988 clade member does not guarantee yield improvements. The variability between lines-with some performing at or below control levels-is precisely why the claimed method requires a selection step for plants exhibiting at least a 6.1% yield increase. This selection step is not an obvious extension of the prior art teachings; it is a purposeful method step that identifies the specific, and necessarily limited, subset of transgenic plants that achieve the claimed performance threshold.
The Claims Require a Specific Selection Step That Is Absent from the Prior Art
The Action has failed to identify any prior art teaching of the selection step that is a critical limitation of the pending claims. Independent claim 1 requires "selecting the transgenic plant that overexpresses the polypeptide having at least 95% percentage identity to the amino acid sequence of SEQ ID NO:530 for having an increased yield of at least 6.1% as compared to a control plant." See Claim 1. Similarly, claim 32 further narrows the selection step to plants exhibiting at least a 9% yield increase. See Claim 32.
Neither Khanna nor Creelman teaches any selection step based on measured yield thresholds. While Creelman reports field trial data as experimental results, reporting yield data post hoc is fundamentally different from teaching a method step of "selecting" plants based on predetermined, quantified yield thresholds as a purposeful aspect of the claimed invention. Compare Creelman at [0269]-[0273] (reporting yield results obtained in field trials) with Claim 1 (requiring affirmative selection of plants meeting a yield threshold). The prior art provides no guidance on:
1. Selecting transgenic plants overexpressing SEQ ID NO:530 (or >95% identity variants
thereof) based on yield measurements;
2. Applying a specific numerical yield threshold (such as 6.1% or 9%) as a selection criterion;
or
3. Employing yield-based selection as a purposeful method step to identify the subset of transgenic plants that meet predetermined performance criteria.
The claimed method is thus materially narrower than what the Action has read into the prior art combination. The claims do not merely recite "overexpressing" a G1988 clade member and observing whatever yield results may occur. Rather, the claims define a method that includes the purposeful selection of plants meeting stringent, quantified yield thresholds-a method step that neither reference teaches, suggests, or enables for the specific claimed polypeptide.
Phylogenetic Similarity Alone Cannot Establish a Reasonable Expectation of Success
The obviousness determination rests heavily on Creelman's general statement that "one skilled in the art would predict that other similar, phylogenetically related sequences falling within the present clades of polypeptides would also perform similar functions when ectopically expressed." Creelman at 1[0141]. But this generalized prediction cannot carry the weight the Action places upon it. A prediction that phylogenetically related proteins will perform "similar functions" is not a teaching that any specific ortholog will produce plants that can be selected for at least a 6.1% yield improvement-particularly where the prior art contains no yield data for that specific ortholog and affirmatively teaches phenotypic divergence.
The Federal Circuit has been unequivocal that obviousness requires more than a general teaching that a genus might possess a particular property; there must be a reasonable expectation that the specific claimed species would exhibit the specific claimed property. See In re Stepan, 868 F.3d 1342, 1345 (Fed. Cir. 2017) (explaining that an obviousness determination requires both a motivation to combine the prior art and a reasonable expectation of success in achieving the claimed invention). The "reasonable expectation of success" prong is not a rubber stamp; it requires evidentiary support, not mere conjecture.
Here, Creelman's own disclosure eviscerates any reasonable expectation of success. Creelman teaches that G4005 exhibited a distinctly different phenotypic profile from G1988- specifically, the absence of elongated hypocotyls despite other indications of altered light response. See Creelman at 1[0288]. When the very reference relied upon for motivation affirmatively teaches that the specific protein at issue does not behave identically to the protein for which yield data exists, one of ordinary skill in the art cannot have a reasonable expectation that yield results would be comparable. The obviousness theory is thus refuted by the very prior art upon which it depends. Accordingly, withdrawal of the rejection under 35 U.S.C. § 103(a) is respectfully requested.
Examiners Response:
After review of Applicant’s arguments, particularly those pertaining to the selection step in claim 1 that is “selecting the transgenic plant that overexpresses the polypeptide having at least 95% percentage identity to the amino acid sequence of SEQ ID NO:530 for having an increased yield of at least 6.1% as compared to a control plant”, Applicant’s arguments have been found persuasive and the 103 rejections to the method claims have been withdrawn.
However, the product-by-process claims are anticipated/ obvious in view of Khanna irrespective of the selection step in the method claim(s) (see 102/103 rejection above).
Conclusion
Claims 1, 2, 9, 11, and 32-34 are allowed.
Claims, 13-15 and 18-24 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA N STOCKDALE whose telephone number is (703)756-5395. The examiner can normally be reached M-F 8:30-5:00 CT.
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JESSICA N. STOCKDALE
Examiner
Art Unit 1663
/JESSICA NICOLE STOCKDALE/Examiner, Art Unit 1663
/CHARLES LOGSDON/Primary Examiner, Art Unit 1662