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
1. Claims 1-20 are pending and are examined on merits in the present Office action.
Specification
2. The specification is objected to for missing deposit information on page 49.
Claim Objection
3. Claims 1-20 are objected to for missing deposit number in claims 1, 11 and 13.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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.
4. Claims 1-20 are rejected (claims 1, 11, and 13 are rejected and, therefore, claims 2-10, 12 and 14-20 which depend therefrom are also 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.
Claims 1, 11, and 13 refer to “NCMA Accession No. ____”. While it is acknowledged that Applicant will/has made a deposit of soybean cultivar 99002218 seed in compliance with 37 C.F.R. § 1.801-1.809 (page 49 of the specification, copied herein below), because the Accession Number information is incomplete within the claims, it is unclear what soybean cultivar 99002218 refers to. The metes and bounds are not clear.
Written Description
5. Claims 18 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a mutagenized soybean plant produced by the method of claim 17, wherein the mutagenized soybean plant comprises a mutation in the genome and otherwise comprises all of the morphological and physiological characteristics of soybean cultivar 99002218.
Given the nature of mutagenizing method listed in claim 17 and open language “comprises”, the mutations in claimed mutagenized soybean plant is unlikely limited to a single mutation.
The specification teaches soybean cultivar 99002218 by depositing the seed thereof and by listing some of the morphological and physiological characteristics of soybean cultivar 99002218 in Table 1.
The Applicants do not describe any mutagenized soybean plant of soybean cultivar 99002218 with multiple mutations. The Applicants also do not describe the morphological and physiological characteristics maintained/not maintained in the mutagenized soybean plant. The Applicants do not describe the conserved genome structure correlated to the morphological and physiological characteristics of mutagenized soybean plant.
The Federal Circuit has recently clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In summary, the court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. The court goes on to say, “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
Applicants fail to describe a representative number of mutagenized plants in claimed genus. Applicants only describe soybean cultivar 99002218 by depositing the seed thereof and by listing some of the morphological and physiological characteristics of soybean cultivar 99002218 in Table 1. Furthermore, Applicants fail to describe structural features common to members of the claimed genus of mutagenized soybean plants. Hence, Applicants fail to meet either prong of the two-prong test set forth by Eli Lilly. Furthermore, given the lack of description of the necessary elements essential for claimed mutagenized soybean plants, it remains unclear what features such mutagenized soybean plants. Since said genus has not been described by specific structural features, the specification fails to provide an adequate written description to support the breath of the claims.
Deposit
6. Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is noted that Applicant has deposited seeds for cultivar 99002218 at the NCMA. However, Applicant’s statement that the deposit was accepted under both standards (i.e. the Budapest Treaty and 1.801-1.809), does not satisfy the requirements under the Budapest Treaty or 1.801-1.809 for a statement which indicates that upon issuance (of a patent) all restrictions on the public availability to the public of the deposit will be irrevocably removed and additionally under 1.801-1.809 guidance, an indication of viability from the depository. Nonetheless, in the absence of the required statements, Applicant’s deposit statement requires clarification.
In order to certify that the deposit, meets the requirements set forth under the terms of the Budapest Treaty, an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the seeds will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would satisfy the deposit requirement made herein.
In order to certify that the deposit, meets the requirements set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
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).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/ guidance/eTD-info-I.jsp.
7. Claims 1-20 are 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 99002218, 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). 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 99002218 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 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.
2. 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.
3. The traits that are (slightly) different are known to be affected by environmental conditions.
4. 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:
1. Relative Maturity: 2.7 (instant variety) vs. 2.4 (EBY) (12.5% difference);
2. Plant Lodging: 7.5 (instant variety) vs. 6.4 (EBY) (12.5% difference);
3. Plant Height: 86 (instant variety) vs. 102 (EBY) (15.7% difference);
4. #Seed/lb (Yield): 2794 (instant variety) vs. 2991 (EBY) (7% difference);
5. Seed% Protein: 34.9% (instant variety) vs. 34.5% (EBY) (1.1% difference); and
6. 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:
1. Occasional variant traits brought in during backcrossing (linkage drag);
2. Environmental conditions;
3. Donor traits; and
4. Differences expected within the error bars of the reported variety values.
Applicant has not provided any information on the following:
1. The donor parent and its traits;
2. The range covered by their reported traits (what differences would be still within the error margin);
3. Evidence that any specific breeding strategies where used to alter any traits other than those typically done in soybean backcrossing methods;
4. Any unexpected results from seen in the instant variety; and
5. 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.
8. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of each of U.S. Patent Application Nos. 18/782,869. Although the claims at issue are not identical, they are not patentably distinct from each other.
The listed patent applications are copending. With respect to the copending patent applications, this is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Although the conflicting claims are not identical, they are not patentably distinct from one another. The subject matter claimed in the instant application is fully disclosed in the referenced copending applications and would be covered by any patent(s) granted on the copending applications since the referenced copending applications and the instant application are claiming common subject matter.
The claims of the instant application and each of 18/782,869 are patentably indistinct because the claims differ only in the name of the cultivars in the claims. These names are in-house designations have no art-accepted meaning.
However, the cultivars all share parents, 11KA71163-56-06 X (11KA71163-56-06(11KA71163-56-06 x OX3009B4-D0YN)), and were made by the same breeding steps.
All the soybean cultivars claimed in the instant and copending applications have yellow seed coats, a dull seed coat luster, yellow cotyledons, ovate leaflets, purple flowers, gray pubescence, gray hilum, tan pods, the MON889788, A5547-127, and MON87708 events, the Rps1c Phytophthora root rot resistance allele, the rhg1 soybean cyst nematode resistance gene, and indeterminate growth.
The soybean cultivars claimed in the instant and copending applications also share similar and/or identical values for relative maturity, lodging, plant height, # seed/lb, seed % protein, and seed % oil..
It is known in the art that the traits of relative maturity, lodging, plant height, # seed/lb, seed % oil, and seed % protein are all affected by the environmental conditions in which the plant is grown.
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) showing how planting date and seeding rate impacts varieties’ lodging score.
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 (see the error bars for data variability).
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).
It is clear that the variation in these (six) traits between the instant cultivar and the other soybean cultivars can be accounted for by differing environmental conditions. As none of the traits distinguish the instant cultivar from those claimed the applications listed above, these cultivars are not distinct and thus are obvious variants.
It is noted that the soybean cultivar claimed in the instant application and the soybean cultivars claimed in some of the co-pending applications differ in is the single gene trait, hilum/hila color (imperfect black vs. gray). However, those claimed soybean cultivars are indistinguishable from a soybean plant of soybean cultivar 99002218 further comprising a single locus conversion, wherein the plant comprises the single locus conversion and otherwise comprises all of the morphological and physiological characteristics of soybean cultivar 99002218. They are also indistinguishable from a mutagenized soybean plant that comprises a mutation in its genome and otherwise comprises all of the morphological and physiological characteristics of soybean cultivar 99002218.
It should be noted that a chemical composition and its properties are inseparable. If the conflicting claims recite the identical chemical structure, the properties Applicant discloses and/ or claims are necessarily present. See MPEP § 2112.01; see also In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Accordingly, with the identical chemical structures, the properties Applicant discloses and/or claims are inherently present in all sets of claims.
Therefore, one of ordinary skill in the art, at the time the application was filed, would have readily recognized that the conflicting claims of the issued U.S. patents and co-pending applications described above and the claims 1-20 in the instant application are obvious variants and are not patentably distinct. Furthermore, there is no apparent reason why Applicant would be prevented from presenting claims corresponding to those of the instant application in the other granted patents and copending application(s). In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.
Firstly, it is acknowledged that a numerically significant difference was shown for the increased lodging resistance between the claimed variety and the reference (prior art) variety, via the art-accepted practice of comparing to a common (set of) check variety. It is also acknowledged that lodging resistance is of agronomical importance.
However, Applicant has not shown that these numerical differences are sufficiently significant to make the claimed variety, in comparison with the prior art teachings, is indeed “different in kind”. See MPEP 2144. III: "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See also Minerals Separation, Ltd. v. Hyde, 242 U.S. 261, 271 (1916); and "It is well established that, while a change in the proportions of a combination shown to be old, such as is here involved, may be inventive, such changes must be critical as compared with the proportions used in the prior processes, producing a difference in kind rather than degree."); In re Wells, 56 F.2d 674, 675 (CCPA 1932); and "[A] modification of a process parameter may be patentable if it ‘produce[s] a new and unexpected result which is different in kind and not merely in degree from the results of the prior art." (citing Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In the instant case, it has not been established that the lodging score of 7.0 is outside of the range provided by the parents, namely “OX3009B4-DoY N”, since a significant amount of genetic material—in addition to the herbicide resistance event—from this parent, was still present in the claimed variety, due to the limited number of back-crossing with the repetitive parent 11KA71163-56-06 (cultivar 57160653). Since it is well known in the art of soybean breeding to select for increased lodging resistance, as it is an important agronomical trait, as Applicant indicated in the Remarks, it would not have been surprising or unexpected if either of the parental lines have the lodging trait encompassing the score of 7.0.
For the reasons stated above, it is determined that it is more proper to maintain the rejection above, after careful preponderance of the evidence.
This is a provisional nonstatutory double patenting rejection.
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.
9. Claims 1-20 are 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 99002218, 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 99002218 is similar to soybean cultivar 11KA71163-56-06 (instant Specification, page 10, paragraph 0076).
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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890
1172
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926
1231
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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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403
717
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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.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI ZHENG whose telephone number is (571)272-8031. The examiner can normally be reached Monday-Friday (9-5).
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/LI ZHENG/Primary Examiner, Art Unit 1662