Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10th, 2025 has been entered.
Applicant’s response in the reply filed 7/10/2025 are acknowledged and fully considered.
Claims 1-17, 19-20 are pending and are examined in this Office action.
Specification
2. The disclosure remains objected to because it contains recitations of blanks: (i) “NCMA Accession No. _____”, and (ii) “date of the deposit is ____”; see page 49, paragraph 00244. It is assumed that the blanks will be replaced with the appropriate deposit accession number. It is also assumed that the corresponding date will be inserted.
Claims Objection
3. Claims 1-17 and 19-20 are objected to for missing NCMA Accession No. in claims 1, 11 and 13.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
4. Claims 1-17, 19-20 remain rejected under 35 U.S.C. 103 as being unpatentable over EBY (Eby, United States Patent No. 9,591,827 B1, issued March 14, 2017) in view of each of DE BEUCKELEER (de Beuckeleer, United States Patent No. 8,017,756 B2, issued September 13, 2011) and MASON (Mason et al., United States Patent No. 9,062,324 B2, issued June 23, 2015).
The claims are drawn to soybean variety 96030818, methods of using it, and products and plants produced from it.
From Applicant’s disclosure, the breeding history seems to be a backcrossing method (see pages 8-9, paragraphs 0068-0070 of Applicant’s Specification; see also IDS filed 11/10/2021). The backcrossing method does not state any specific selection protocol, and the record seems to indicate that the difference between the recurrent parent and the instant variety is the addition of Event A5547-127, which confers resistance to glufosinate herbicides. See for example paragraph 0075 bridging pages 10-11 of the Applicant’s Specification.
Applicant concedes that soybean cultivar 96030818 is similar to soybean cultivar 11KA71163-56-06 (instant Specification, page 10, paragraph 0075).
EBY teaches soybean cultivar 57160653 (entire document; see Title, Abstract, for example). Cultivar variety 57160653 is also known as soybean variety 11KA71163-56-06, which is as such described and claimed by EBY (claims 1-2 of EBY; col. 6, lines 43-44, Table 1). Like the instant soybean, 11KA71163-56-06 has purple flowers, gray pubescence, tan pods, yellow, dull seed coats, yellow cotyledons, ovate leaflets, the MON889788 and MON87708 events, the Rps1c Phytophthora root rot resistance allele, the rhg1 soybean cyst nematode resistance gene, and indeterminate growth (Table 1; col. 7, lines 8-19).
It is important to note that soybean variety 11KA71163-56-06 appears to be used as a recurrent parent in the instant Specification.
It is further important to note that Applicant does not allege any practically significant differences or any unexpected results when comparing the recurrent parent to the instant variety other than the newly conferred resistance to glufosinate herbicides added by the AA547-127 event.
It is also important to note that while Applicant’s breeding history refers to pedigree breeding in paragraph 0068, it is only generically recited and does not clarify whether the pedigree breeding was to make the backcross progeny more like the recurrent parent, or to add further traits from a donor plant.
EBY teaches that 11KA71163-56-06 and the instant soybean have similar values for relative maturity, lodging, plant height, #seeds/lb, % seed oil, and % seed protein.
EBY teaches and claims cells, tissue culture of the plant (claims 3-4 of EBY), methods of crossing the soybean with itself or another soybean plant, including a series of crosses to produce a soybean plant derived from the original line (claims 5-6 of EBY), F1 progeny seeds (claim 7 of EBY), introducing transgenes into the plant, including those conferring h male sterility, herbicide resistance, insect or pest resistance, disease resistance, modified fatty acid metabolism, abiotic stress tolerance, or modified carbohydrate metabolism, and plants thereby produced (claims 8-10 of EBY), a method of introducing a single locus conversion into the plant, including one conferring male sterility, herbicide resistance, insect or pest resistance, disease resistance, modified fatty acid metabolism, abiotic stress tolerance, or modified carbohydrate metabolism, and plants thereby produced (claims 11-13 of EBY), a method of using the plant to produce a different inbred soybean plant (claims 14-17 of EBY), a method of mutagenizing the plant (claim 17 of EBY), and methods of producing commodity products, including protein isolates, protein concentrate, hulls, meal, flour and oil (claims 18-19 of EBY).
EBY teaches that the locus conversion can be for herbicide tolerance (see claim 12 of EBY).
EBY teaches that that backcrossing includes at least two crosses (col. 25, lines 10-29).
EBY further teaches that when backcrossing, occasional variant traits may be added to the recurrent parent (col. 23, line 60 – col. 24, line 10).
EBY further teaches that when performing a backcrossing conversion, an additional pedigree breeding process can be added in combination with the backcrossing process. EBY discloses that this pedigree process can be used to move the backcross progeny closer to the recurrent parent or to add traits of the donor to the recurrent parent (col. 29, lines 22-43).
EBY differs from the instantly claimed soybean variety in relative maturity, plant lodging, plant height, #seed/lb, seed protein %, seed oil %; and EBY does not explicitly teach soybean variety 11KA71163-56-06 with the A5547-127 event, which confers tolerance to glufosinate herbicides. However, such claimed compositions and the recited methods practiced with the compositions would have been prima facie obvious to a person of ordinary skill in the art at the time the application was filed for the following reasons.
It is first noted that Applicant concedes that the A5547-127 event (also known as EE-GM2, LL55, and ACS-GM006-4) is in the prior art and taught by DE BEUCKELEER (United States Patent No. 8,017,756) and MASON (United States Patent No. 9,062,324) (see Applicant’s Specification, page 10, paragraph 0071).
DE BEUCKELEER teaches elite event A5547-127 and methods and kits for identifying such event in biological samples (entire document; see Title, Abstract, for example).
DE BEUCKELEER teaches soybean plants with the A5547-127 event, which confers glufosinate tolerance without otherwise compromising agronomic performance (col. 25, lines 1-36; col. 26, lines 34-42).
MASON teaches herbicide tolerant soybean plants and methods for identifying same (entire document; see Title, Abstract, for example).
MASON teaches that the EE-GM2 (A5547-127) event, which is to be added to soybean cultivars to impart glyphosate tolerance, wherein the event is in a seed deposited at NCIMB (41659) (col. 3, lines 61-67). Mason further teaches that the 41659 seed is to be used to cross with other soybean plants to impart glyphosate tolerance (col. 3, line 65 – col. 4, line 12).
MASON teaches that the elite EE-GM2 event is to be introduced by repeated backcrossing into commercial soybean cultivars (col. 51, line 32 – col. 66, line 55).
MASON teaches stacking of the EE-GM2 event with other herbicide tolerance event such as MON89788 (col. 66, line 2).
MASON further teaches that when the EE-GM2 (A5547-127) event is introgressed into an elite soybean cultivar, one expects that there is some influence of desirable phenotypes of the recurrent parent in a backcross method. MASON states that generally there is not a significant influence on traits when doing a backcross (col. 65, lines 56-61).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to introduce the A5547-127 event (taught by DE BEUCKELEER and MASON) into soybean variety 11KA71163-56-06 (taught by EBY) by backcrossing. One of ordinary skill in the art would have been motivated to do so because doing so would confer herbicide resistance to 11KA71163-56-06, thus allowing it to survive in a field sprayed with glufosinate, in addition to glyphosate and/or dicamba, to control weeds. Stated otherwise, it would have been obvious to backcross the A5547-127 event taught by both DE BEUCKELEER and MASON into the soybean variety taught by EBY, to combine the glyphosate resistance of DE BEUCKELEER and/or MASON with the glufosinate resistance in EBY in order to have a soybean resistant to broad spectrum herbicide use. Additionally, EBY suggests introducing glufosinate resistance into the plant (col. 16, lines 22-34); the A5547-127 event is one way to achieve that, with the advantage that it does not otherwise compromise agronomic performance (DE BEUCKELEER, col. 25, lines 1-36; col. 26, lines 34-42).
One of ordinary skill in the art would have introduced transgenes and single locus conversions into the plant, including those conferring male sterility, herbicide resistance, insect or pest resistance, disease resistance, modified fatty acid metabolism, abiotic stress tolerance, or modified carbohydrate metabolism, as taught by EBY. One of ordinary skill in the art would have been motivated to do so because would introduce further desired traits; for example insect resistance would allow the plants to grown in areas with pests.
One of ordinary skill in the art would have crossed the resulting soybean with itself or another soybean plant, including a series of crosses to produce a soybean plant derived from the original line, including F1 progeny seeds and plants, as taught by EBY. One of ordinary skill in the art would have been motivated to do so because this would allow one to introduce soybean 11KA71163-56-06’s traits into other, new soybean lines.
One of ordinary skill in the art would have introduced transgenes and single locus conversions into the soybean plant taught by EBY, including those conferring male sterility, herbicide resistance, insect or pest resistance, disease resistance, modified fatty acid metabolism, abiotic stress tolerance, or modified carbohydrate metabolism. One of ordinary skill in the art would have been motivated to do so because would introduce further desired traits; for example insect resistance would allow the plants to grown in areas with pests.
One of ordinary skill in the art would have mutagenized the resulting soybean, as taught by EBY. One of ordinary skill in the art would have been motivated to do so because this would allow one to introduce new traits into variety 11KA71163-56-06.
One of ordinary skill in the art would have crossed the resulting soybean with itself or another soybean plant, including a series of crosses to produce a soybean plant derived from the original line, including F1 progeny seeds and plants, as taught and claimed by EBY. One of ordinary skill in the art would have been motivated to do so because this would allow one to introduce 11KA71163-56-06’s traits into other, new soybean lines.
One of ordinary skill in the art would have produced commodity products, including protein isolates, protein concentrate, hulls, meal, flour and oil from the soybean, as taught by EBY. One of ordinary skill in the art would have been motivated to do so because these are the economically important products from soybeans and ones of the main reason farmers grow soybeans.
Plant culture, plant breeding, crossing, morphological, biochemical, and physiological assays, and phenotypic analyses of soybeans are techniques that were routine in the art at the time the application was filed, as taught by the cited references and the state of the art in general.
It is also noted that, in comparing the recurrent parent (EBY variety) and the backcross progeny (instant application variety), the 35 USC § 103 rejection in fact is based on the interpreted locus conversion (backcross) of EBY, and likely there would be changes in the resultant progeny, and that progeny is likely the best point of comparison. However, the Office does not have the resources to create backcross progeny and test the traits to see what the normal range of acceptable variants would be. Applicant is pointed to MPEP § 2112.01, which states that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)”. The Office’s position is that the proposed combination of EBY and each of DE BEUCKELEER or MASON is substantially identical in structure to the instantly claimed variety.
Soybean variety 11KA71163-56-06 and the instant soybean variety have identical values for 14 of 20 compared traits. They also have similar values for the remaining six traits, namely relative maturity, lodging, plant height, #seeds/lb, % seed oil, and % seed protein. These differences are highly influenced by environmental conditions. They are merely a difference in degree and not in kind, and would be expected by one of ordinary skill in the art introgressing one trait from one plant into another.
It is well settled in Patent Law that the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c). See MPEP § 716.02(b).
It is noted that Applicant has not described any practically significant difference or unexpected property in the instant variety other than the introgression of the transgenic event. Applicant has not described any selection pressure that would account for any of the trait changes where relative differences are present. From the record at hand, these differences seem to be the expected differences when producing backcross progeny plants as acknowledged by EBY, DE BEUCKELEER, and MASON.
It is also important to note that Applicant is the owner of the EBY prior art, and had the ability to exclude anyone from using the EBY patent in a backcrossing method for adding herbicide resistance (see claims 11-12 in EBY). From the EBY patent and the instant application it is not clear what backcrosses would be covered by the EBY patent, and what would not be covered. It is the Office’s position that the instant variety is a covered member of the genus of plants given to the Applicant in the EBY patent, for example in claims 11-12. Applicant has not alleged any unexpected results and practically significant differences.
Additionally, the differences between EBY and the instant variety can be accounted for in the following ways:
EBY discloses that the traits are determined at the 5% significance level when grown in the same conditions (see EBY, col. 26, line 28, and col. 28. line 38). The Office does not have the data in EBY or the instant application to compare the two varieties to see if the differences are within the margin of error.
Backcrossing induces expected changes to the traits of the recurrent parent. As discussed above differences are expected, applicant have provided no data or information that the differences are unexpected or practically significant.
The traits that are (slightly) different are known to be affected by environmental conditions.
The Applicant has provided no information about the donor plant. It is possible some of the variant traits are from the genetic makeup of the donor. Without knowledge of the donor traits, it is difficult for the Office to determine if any differences are practically significant or unexpected.
The traits that are different are as follows:
Relative Maturity: 2.7 (instant variety) vs. 2.4 (EBY) (12.5% difference);
Plant Lodging: 7.5 (instant variety) vs. 6.4 (EBY) (12.5% difference);
Plant Height: 86 (instant variety) vs. 102 (EBY) (15.7% difference);
#Seed/lb (Yield): 2794 (instant variety) vs. 2991 (EBY) (7% difference);
Seed% Protein: 34.9% (instant variety) vs. 34.5% (EBY) (1.1% difference); and
Seed% Oil: 19.8% (instant variety) vs. 19.1% (EBY) (3.7% difference).
However, all of the above traits are known in the art to be affected by environmental conditions. For example, Boehm (Jeffrey David Boehm Jr., 2014, Molecular Marker Assisted Backcross Development and Evaluation of an Environmentally Friendly, Commercially Acceptable Low Seed Phytate Soybean, Master’s Thesis, University of Tennessee-Knoxville, pp 1-135) teaches that a high yielding soybean cultivar, 5601T, was used to develop 12 BC5 (5th generation backcross lines), which introgressed an LP (low phytate) trait from a soybean donor line (TN09-239). The 5th generation backcross progeny were expected to be 98.4% genetically similar to the recurrent parent 5601T (see page 5). The backcross progeny was grown in two locations (ETREC and Milan) in two years (2012 and 2013) (see Tables 5.4 and 5.5 on pages 132-133).
When reviewing Tables 5.4 and 5.5 of Boehm, a person having the ordinary skill in the art would see that when introgressing traits into soybean cultivars via backcrossing, it is expected that the backcrossing steps would cause the resultant backcross progeny to differ from the recurrent parent in many traits to some degree, even during five backcrosses, which conserves 98.4% of the genetic DNA. Note that in the instant case Applicant’s differences seem less substantial, even though there were only two backcrosses.
Specifically, when looking at Tables 5.4 and 5.5 of Boehm, the backcross progeny can differ substantially from the parents even when taken to the 5th generation. In Table 5.4, the backcross progeny has a large distribution of yield, lodging, and height when compared to the recurrent parent. Additionally, the backcross progeny differs only slightly from the recurrent parent for maturity, protein, and oil content. For yield, lodging, and height the differences were greater than 15%. For maturity, protein, and oil content, they were under 5%.
In Table 5.4, when comparing the traits for the same varieties in different locations (ETREC vs. Milan) in the same year, there is substantial variability in all metrics likely due to environmental impacts. In Tables 5.4 and 5.5 when comparing the yield, maturity, lodging, height, protein, and oil content, there are substantial differences from 2012 and 2013 data. Likely these are due to environmental impacts.
Accordingly, when looking at Tables 5.4 and 5.5 of Boehm, the backcross soybean progeny can differ substantially from the parents even when taken to the 5th generation.
The art provides numerous examples where many of the traits that are different between EBY and the instant variety are known to be environmentally effected.
For example, with respect to relative maturity “an early maturing variety in one region may be considered a late variety in another region.” See Liu et al., 2017, Genetic variation of world soybean maturity date and geographic distribution of maturity groups, Breeding Science 67: 221-232, at page 221, right-hand col. Relative maturity is affected by growing temperature and the amount of daylight (Iowa State University Extension and Outreach, 2018, Soybean Planting and Decision Tool, available at https://crops.extension.iastate.edu/facts/soybean-planting-decision-tool , accessed March 26, 2022.
Seed oil content and seed protein content are genetically determined, but can vary depending on environment. See Sobko et al., 2020, Environmental Effects on Soybean (Glycine Max (L.) Merr) Production in Central and South Germany, Agronomy 10, 1847, pp 1-14, at page 2, second - last full paragraphs. Protein and oil concentrations in seed have been shown to vary with the application of fertilizer. See Assefa et al., 2019, Assessing Variation in US Soybean Seed Composition (Protein and Oil), Front. Plant Sci. 10: 298, pp 1-13.
Lodging score is affected by planting date and seeding rate. See Pioneer, 2014, “Plant Seeding Rate on Soybean Lodging and Yield” (2014 data shown), available at https://www.pioneer.com/us/agronomy/planting_date_effects_lodging_yield_soybeans.html (accessed March 26, 2022). See in particular pages 5-6 (Figures 5-6; also reproduced below) showing how planting date and seeding rate impacts varieties’ lodging score.
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Plant (soybean) height is affected by a wide range of environmental conditions (Yang et al., 2021, Environmental and genetic regulation of plant height in soybean, BMC Plant Biology 21:63, pp 1-15; see paragraph spanning the columns on page 2). Further with respect to plant height, it was shown by Xue et al., 2019, Mapping developmental QTL for plant height in soybean [Glycine max (L.) Merr.] using a four-way recombinant inbred line population, PLoS ONE, https://doi.org/10.1371/journal.pone.0224897 November 20, 2019, pp 1-15, show that plant height varies approximately 10 cm due to environmental conditions (pages 4-5), specifically sowing date as shown in Figure 1 (also reproduced below; see the error bars for data variability).
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Seed size (expressed as #seed/lb) has been shown to vary between varieties, but more significantly varies due to weather conditions during seed-filling, particularly extreme late-season stress (Wiebold, 2008, Soybean Seed Size Does Not Affect Yield Performance, Integrated Pest & Crop Management, University of Missouri, pp 1, paragraphs 2 and 5; available at https://ipm.missouri.edu/cropPest/2008/11/Soybean-Seed-Size-Does-Not-Affect-Yield-Performance/index.cfm, accessed March 26, 2022). This variation can be as much as 20% within a given variety and is determined by the environmental conditions during the growing season (Staton, 2017, Recommendations for planting large soybean seed, Michigan State University Extension, pp 1-4, page 2, first paragraph; available at https://www.canr.msu.edu/news/recommendations_for_planting_large_soybean_seed, accessed March 26, 2022).
In summary, it is the Office’s position that the prior art EBY covers a genus of backcross progeny plants. In the instant case, the event backcrossed in was contemplated by the combination of EBY and each of DE BEUCKELEER or MASON. It is also the Office’s position that the EBY patent in combination with each of DE BEUCKELEER or MASON covers the instantly described changes to the traits disclosed in EBY.
The differences between the instant variety and the recurrent parent described in EBY are more likely than not attributable to the following:
Occasional variant traits brought in during backcrossing (linkage drag);
Environmental conditions;
Donor traits; and
Differences expected within the error bars of the reported variety values.
Applicant has not provided any information on the following:
The donor parent and its traits;
The range covered by their reported traits (what differences would be still within the error margin);
Evidence that any specific breeding strategies where used to alter any traits other than those typically done in soybean backcrossing methods;
Any unexpected results from seen in the instant variety; and
Any differences that rise to a practical significance (difference in kind).
Without any of the above information it is likely that the observed minor differences are among the expected differences that are likely to occur during backcrossing under different environmental conditions.
Applicants traverse in the paper filed 7/10/2025. Applicants’ arguments as well as submission of Declaration under rule 132 by Justin Masonhave been fully considered but were not found persuasive.
Applicant argues that according to the Declaration of Mr. Justin T. Mason, submitted on 7/10/2025 under 37 C.F.R. 1.132, there is no evidence to suggest that introgressing event A5547-127 increases yield or lodging resistance, and that the comparative data on record demonstrate that the claimed cultivar exhibits significant improvements over soybean cultivar 57160653 (pages 6-7 of the Remarks). Applicant argues that the Mason Declaration confirms the data in the previously submitted declarations (page 7).
Mr. Mason states as follows: “the only peer reviewed research I am aware of that relates any herbicide tolerance event directly to yield is Duke et al. (Pest Management Science. 2017), provided in Exhibit B herewith. Duke et al. explains that the glyphosate-resistance (GR) transgene, glyphosate use on 2 2 GR soybean, and soils with a history of glyphosate use have no effect on the yield production of soybean seed. Duke et al. also explains that this is consistent with previous studies although some have claimed that glyphosate negatively affects the yield of GR soybean” (paragraph 7 of the Declaration).
Mr. Mason argues that the teachings of De Beuckeleer do not provide evidence that introgressing event A5547-127 is connected to yield not that significantly increasing yield would be expected as a result of the presence of event A5547-127” (paragraph 10).
Mr. Mason argues that the previously submitted declarations provide data that “represent a valid means to compare the agronomic characteristics of soybean cultivar 96030818 [claimed variety] and 57160653 [recurrent variety, known in the prior art]” (paragraph 11). Mr. Mason argues that a comparison between the claimed and a reference cultivar with a check variety is valid even if performed in different years (paragraph 13). Mr. Mason argues that using said comparison against a check variety, the claimed cultivar showed significantly higher yield and resistance to stem lodging than the recurrent parent.
Applicant’s argument is not found to be persuasive. The Declaration of Mr. Mason submitted under 37 C.F.R. 1.132 on 7/10/2025 was fully considered but it is not sufficient to overcome the instant rejection, for the following reasons.
As an initial matter, neither the above rejection nor the previous Office Action take the position that the introgression of the event A5547-147 would be a sufficient cause of increased yield in the progeny. Contrary to the Declaration’s statements, the Office Action does not assert that the “increase in yield would be expected by introgressing event A5547-147” (see paragraphs 1, 3, and 5 of the Declaration); and the Declaration does not cite any specific portions of the Office Action in support.
Moreover, a showing that the introgression of event A5547-147 into the variety of Eby would have resulted in any unexpected increase in yield, lodging resistance, or a more favorable relative maturity, is not required to support a prima facie finding of obviousness. Notably, while the specification, in Table 2 on page 48, does show that the yield for the claimed cultivar was slightly higher than that of a known variety, the specification provides no comparison to either of the parents used to obtain the claimed cultivar 96030818, or otherwise indicate that the yield was unexpected. Similarly, the specification is silent with regard to any changes in lodging resistance or relative maturity of the claimed cultivar 96030818 being unexpected in view of the properties of either the recurrent or donor parent. Applicant supplied no information regarding the donor parent. At the same time, as set forth in the rejection above, it is known in the art (see Eby, above) that when introgressing a trait into a soybean cultivar via backcrossing, one would reasonably expect that the traits of the resultant progeny may differ from those of either parent.
Further, the references on which the Declaration relies in paragraphs 5-6 are inapplicable to the instant scenario. The USDA document merely states that the soybean plants comprising event A5547-127, which was introduced by transforming a pat transgene into a soybean variety, had “identical agronomic characteristics” to the starting variety. However, unlike a variety produced by introgression, the plants of event A5547-127, discussed in the UDSA document, would not be expected to comprise any genetic material other than the vector used to obtain the event.
Similarly, as the Duke article shows, it would not have been unexpected that the presence of the CP4 EPSPS transgene in a soybean plant may not necessarily confer increased yield. However, Duke et al teach that said transgene does result in greater yields at least in plants treated with glyphosate in comparison with those treated with other herbicides. Duke et al teach as follows: “Kandel et al reported at some locations glyphosate-treated GR soybean had significantly greater yields than GR soybean in which herbicides other than glyphosate were used for weed management. Similarly, Williams et al found glyphosate treated GR maize to have higher yields than the same cultivar with weeds managed by means other than with glyphosate” (page 7, left col.) Neither Applicant’s Remarks nor the Declaration address these teachings of Duke et al or reconcile them with the statements in paragraph 6 of the Declaration.
With regard to the data submitted in the previous declarations and affirmed by Mr. Mason in the instant one, they are not sufficient to overcome the rejection. Even assuming that the comparisons between the check variety and either the recurrent parent or the claimed cultivar are valid, they are not sufficient to make a showing of unexpected results, because the increase in the yield and lodging resistance could be reasonably attributed to the genetic material from the donor parent. This is particularly true given that, as paragraph 11 of the Declaration of Dr. James Hampton indicates, the claimed cultivar was obtained after three rounds of backcrossing. This means that the resultant cultivar will comprise a substantial amount (12.5%) of the genetic material from the donor. It is noted that neither the specification nor the declarations supply any information regarding the characteristics of the donor variety, including yield or lodging. If, for example, the average yield of the donor used by Applicant was higher than that of 57160653, it would not be unexpected that the resultant progeny may show yield that falls between the values for the two parents, yet still higher than that for the recurrent one, particularly given that yield is a quantitative trait.
For example, Thomas et al teach that the average yield for variety DLL0750 was 66.93 bu/ac, which was 105.9% of the yield of an unspecified check variety (Table 1 in col. 2). Although Eby does not provide a value for the average yield of cultivar 57160653, if that value is lower than that of DLL0750, one could reasonably expect that the backcrossed progeny would show yield higher than that of 57160653. While the Examiner is not required to make a showing of the absence of unexpected results for a prima facie finding of obviousness, this example indicates that Applicant cannot validly show the presence of unexpected results without factoring in the properties of the second parent used to obtain the claimed cultivar.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR § 1.321(c) or § 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR § 1.321(b).
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5. Claims 1-17 and 19-20 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of United States Patent No. 9,591,827 B1, issued March 14, 2017) in view of each of DE BEUCKELEER (de Beuckeleer, United States Patent No. 8,017,756 B2, issued September 13, 2011) and MASON (Mason et al., United States Patent No. 9,062,324 B2, issued June 23, 2015).
The claims are drawn to soybean variety 96030818, methods of using it, and products and plants produced from it.
From Applicant’s disclosure, the breeding history seems to be a backcrossing method (see pages 8-9, paragraphs 0068-0070 of Applicant’s Specification; see also IDS filed 11/10/2021). The backcrossing method does not state any specific selection protocol, and the record seems to indicate that the difference between the recurrent parent and the instant variety is the addition of Event A5547-127, which confers resistance to glufosinate herbicides. See for example paragraph 0075 bridging pages 10-11 of the Applicant’s Specification.
Applicant concedes that soybean cultivar 96030818 is similar to soybean cultivar 11KA71163-56-06 (instant Specification, page 10, paragraph 0075).
EBY teaches soybean cultivar 57160653 (entire document; see Title, Abstract, for example). Cultivar variety 57160653 is also known as soybean variety 11KA71163-56-06, which is as such described and claimed by EBY (claims 1-2 of EBY; col. 6, lines 43-44, Table 1). Like the instant soybean, 11KA71163-56-06 has purple flowers, gray pubescence, tan pods, yellow, dull seed coats, yellow cotyledons, ovate leaflets, the MON889788 and MON87708 events, the Rps1c Phytophthora root rot resistance allele, the rhg1 soybean cyst nematode resistance gene, and indeterminate growth (Table 1; col. 7, lines 8-19).
It is important to note that soybean variety 11KA71163-56-06 appears to be used as a recurrent parent in the instant Specification.
It is further important to note that Applicant does not allege any practically significant differences or any unexpected results when comparing the recurrent parent to the instant variety other than the newly conferred resistance to glufosinate herbicides added by the AA547-127 event.
It is also important to note that while Applicant’s breeding history refers to pedigree breeding in paragraph 0068, it is only generically recited and does not clarify whether the pedigree breeding was to make the backcross progeny more like the recurrent parent, or to add further traits from a donor plant.
EBY teaches that 11KA71163-56-06 and the instant soybean have similar values for relative maturity, lodging, plant height, #seeds/lb, % seed oil, and % seed protein.
EBY teaches and claims cells, tissue culture of the plant (claims 3-4 of EBY), methods of crossing the soybean with itself or another soybean plant, including a series of crosses to produce a soybean plant derived from the original line (claims 5-6 of EBY), F1 progeny seeds (claim 7 of EBY), introducing transgenes into the plant, including those conferring h male sterility, herbicide resistance, insect or pest resistance, disease resistance, modified fatty acid metabolism, abiotic stress tolerance, or modified carbohydrate metabolism, and plants thereby produced (claims 8-10 of EBY), a method of introducing a single locus conversion into the plant, including one conferring male sterility, herbicide resistance, insect or pest resistance, disease resistance, modified fatty acid metabolism, abiotic stress tolerance, or modified carbohydrate metabolism, and plants thereby produced (claims 11-13 of EBY), a method of using the plant to produce a different inbred soybean plant (claims 14-17 of EBY), a method of mutagenizing the plant (claim 17 of EBY), and methods of producing commodity products, including protein isolates, protein concentrate, hulls, meal, flour and oil (claims 18-19 of EBY).
EBY teaches that the locus conversion can be for herbicide tolerance (see claim 12 of EBY).
EBY teaches that that backcrossing includes at least two crosses (col. 25, lines 10-29).
EBY further teaches that when backcrossing, occasional variant traits may be added to the recurrent parent (col. 23, line 60 – col. 24, line 10).
EBY further teaches that when performing a backcrossing conversion, an additional pedigree breeding process can be added in combination with the backcrossing process. EBY discloses that this pedigree process can be used to move the backcross progeny closer to the recurrent parent or to add traits of the donor to the recurrent parent (col. 29, lines 22-43).
EBY differs from the instantly claimed soybean variety in relative maturity, plant lodging, plant height, #seed/lb, seed protein %, seed oil %; and EBY does not explicitly teach soybean variety 11KA71163-56-06 with the A5547-127 event, which confers tolerance to glufosinate herbicides. However, such claimed compositions and the recited methods practiced with the compositions would have been prima facie obvious to a person of ordinary skill in the art at the time the application was filed for the following reasons.
It is first noted that Applicant concedes that the A5547-127 event (also known as EE-GM2, LL55, and ACS-GM006-4) is in the prior art and taught by DE BEUCKELEER (United States Patent No. 8,017,756) and MASON (United States Patent No. 9,062,324) (see Applicant’s Specification, page 10, paragraph 0071).
DE BEUCKELEER teaches elite event A5547-127 and methods and kits for identifying such event in biological samples (entire document; see Title, Abstract, for example).
DE BEUCKELEER teaches soybean plants with the A5547-127 event, which confers glufosinate tolerance without otherwise compromising agronomic performance (col. 25, lines 1-36; col. 26, lines 34-42).
MASON teaches herbicide tolerant soybean plants and methods for identifying same (entire document; see Title, Abstract, for example).
MASON teaches that the EE-GM2 (A5547-127) event, which is to be added to soybean cultivars to impart glyphosate tolerance, wherein the event is in a seed deposited at NCIMB (41659) (col. 3, lines 61-67). Mason further teaches that the 41659 seed is to be used to cross with other soybean plants to impart glyphosate tolerance (col. 3, line 65 – col. 4, line 12).
MASON teaches that the elite EE-GM2 event is to be introduced by repeated backcrossing into commercial soybean cultivars (col. 51, line 32 – col. 66, line 55).
MASON teaches stacking of the EE-GM2 event with other herbicide tolerance event such as MON89788 (col. 66, line 2).
MASON further teaches that when the EE-GM2 (A5547-127) event is introgressed into an elite soybean cultivar, one expects that there is some influence of desirable phenotypes of the recurrent parent in a backcross method. MASON states that generally there is not a significant influence on traits when doing a backcross (col. 65, lines 56-61).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to introduce the A5547-127 event (taught by DE BEUCKELEER and MASON) into soybean variety 11KA71163-56-06 (taught by EBY) by backcrossing. One of ordinary skill in the art would have been motivated to do so because doing so would confer herbicide resistance to 11KA71163-56-06, thus allowing it to survive in a field sprayed with glufosinate, in addition to glyphosate and/or dicamba, to control weeds. Stated otherwise, it would have been obvious to backcross the A5547-127 event taught by both DE BEUCKELEER and MASON into the soybean variety taught by EBY, to combine the glyphosate resistance of DE BEUCKELEER and/or MASON with the glufosinate resistance in EBY in order to have a soybean resistant to broad spectrum herbicide use. Additionally, EBY suggests introducing glufosinate resistance into the plant (col. 16, lines 22-34); the A5547-127 event is one way to achieve that, with the advantage that it does not otherwise compromise agronomic performance (DE BEUCKELEER, col. 25, lines 1-36; col. 26, lines 34-42).
One of ordinary skill in the art would have introduced transgenes and single locus conversions into the plant, including those conferring male sterility, herbicide resistance, insect or pest resistance, disease resistance, modified fatty acid metabolism, abiotic stress tolerance, or modified carbohydrate metabolism, as taught by EBY. One of ordinary skill in the art would have been motivated to do so because would introduce further desired traits; for example insect resistance would allow the plants to grown in areas with pests.
One of ordinary skill in the art would have crossed the resulting soybean with itself or another soybean plant, including a series of crosses to produce a soybean plant derived from the original line, including F1 progeny seeds and plants, as taught by EBY. One of ordinary skill in the art would have been motivated to do so because this would allow one to introduce soybean 11KA71163-56-06’s traits into other, new soybean lines.
One of ordinary skill in the art would have introduced transgenes and single locus conversions into the soybean plant taught by EBY, including those conferring male sterility, herbicide resistance, insect or pest resistance, disease resistance, modified fatty acid metabolism, abiotic stress tolerance, or modified carbohydrate metabolism. One of ordinary skill in the art would have been motivated to do so because would introduce further desired traits; for example insect resistance would allow the plants to grown in areas with pests.
One of ordinary skill in the art would have mutagenized the resulting soybean, as taught by EBY. One of ordinary skill in the art would have been motivated to do so because this would allow one to introduce new traits into variety 11KA71163-56-06.
One of ordinary skill in the art would have crossed the resulting soybean with itself or another soybean plant, including a series of crosses to produce a soybean plant derived from the original line, including F1 progeny seeds and plants, as taught and claimed by EBY. One of ordinary skill in the art would have been motivated to do so because this would allow one to introduce 11KA71163-56-06’s traits into other, new soybean lines.
One of ordinary skill in the art would have produced commodity products, including protein isolates, protein concentrate, hulls, meal, flour and oil from the soybean, as taught by EBY. One of ordinary skill in the art would have been motivated to do so because these are the economically important products from soybeans and ones of the main reason farmers grow soybeans.
Plant culture, plant breeding, crossing, morphological, biochemical, and physiological assays, and phenotypic analyses of soybeans are techniques that were routine in the art at the time the application was filed, as taught by the cited references and the state of the art in general.
It is also noted that, in comparing the recurrent parent (EBY variety) and the backcross progeny (instant application variety), the 35 USC § 103 rejection in fact is based on the interpreted locus conversion (backcross) of EBY, and likely there would be changes in the resultant progeny, and that progeny is likely the best point of comparison. However, the Office does not have the resources to create backcross progeny and test the traits to see what the normal range of acceptable variants would be. Applicant is pointed to MPEP § 2112.01, which states that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)”. The Office’s position is that the proposed combination of EBY and each of DE BEUCKELEER or MASON is substantially identical in structure to the instantly claimed variety.
Soybean variety 11KA71163-56-06 and the instant soybean variety have identical values for 14 of 20 compared traits. They also have similar values for the remaining six traits, namely relative maturity, lodging, plant height, #seeds/lb, % seed oil, and % seed protein. These differences are highly influenced by environmental conditions. They are merely a difference in degree and not in kind, and would be expected by one of ordinary skill in the art introgressing one trait from one plant into another.
It is well settled in Patent Law that the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c). See MPEP § 716.02(b).
It is noted that Applicant has not described any practically significant difference or unexpected property in the instant variety other than the introgression of the transgenic event. Applicant has not described any selection pressure that would account for any of the trait changes where relative differences are present. From the record at hand, these differences seem to be the expected differences when producing backcross progeny plants as acknowledged by EBY, DE BEUCKELEER, and MASON.
It is also important to note that Applicant is the owner of the EBY prior art, and had the ability to exclude anyone from using the EBY patent in a backcrossing method for adding herbicide resistance (see claims 11-12 in EBY). From the EBY patent and the instant application it is not clear what backcrosses would be covered by the EBY patent, and what would not be covered. It is the Office’s position that the instant variety is a covered member of the genus of plants given to the Applicant in the EBY patent, for example in claims 11-12. Applicant has not alleged any unexpected results and practically significant differences.
Additionally, the differences between EBY and the instant variety can be accounted for in the following ways:
1. EBY discloses that the traits are determined at the 5% significance level whe