DETAILED ACTION
Claims 1-20 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The specification is objected to for the presence of blank lines in ¶245 and for the use of non-metric units of measure (lb or pound) in at least Tables 1-2 and ¶65-66.
Deposit of Biological Material
This application requires public availability of specific biological material to make and use the claimed invention. A rejection under the appropriate sections of 35 USC 112 would have been made but for Applicant’s statement in ¶245 indicating that an acceptable deposit of the specific biological material in compliance with the requirements under 37 CFR 1.801-1.809 will be made with a recognized IDA, at or before the payment of the issue fee, in the event that the application should be determined to be allowable.
Because viability testing of all deposits is required before they can be considered to meet the requirements of 37 CFR 1.801-1.809, applicants are advised to perfect the deposit as early as is possible, and before the payment of the issue fee. Failure to perfect a deposit by the date of payment of the issue fee may result in abandonment of the application for failure to prosecute.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claim 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 18 is drawn to a mutagenized soybean that comprises a mutation and otherwise comprises all the morphological and physiological characteristics of soybean cultivar 04150104.
EMS mutagensis of soybean can produce over 20,000 mutations per plant (Tsuda et al, 2015, BMC Genomics 16:1014; pg 4, right column, paragraph 1).
Thus, the claim encompasses soybean plants that can have almost any number of mutations in any number of morphological and physiological characteristics relative to soybean cultivar 04150104.
The specification describes no structural features that distinguish soybean plants that differ from morphological and physiological characteristics of soybean cultivar 04150104 in any number of traits from other soybean plants.
Hence, Applicant has not, in fact, described mutagenized soybean plants over the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
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, 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.
Claims 1-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Eby (2017, US 9,591,827) in view of de Beuckleer (2011, US 8,017,756).
The claims are drawn to soybean variety 04150104, methods of using it, and products and plants produced from it. 11KA71163-56-06 is the recurrent parent of 04150104 (¶68).
Eby teaches soybean variety 11KA71163-56-06, which is also known as 57160653 (claims 1-2, column 6, lines 43-44, Table 1). Like the instant soybean, 11KA71163-56-06 has purple flowers, gray pubescence, tan pods, gray hila, 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; column 7, lines 8-19). 11KA71163-56-06 and the instant soybean have similar values for relative maturity, lodging, plant height, seeds/lb, and % seed oil and protein. Eby does not teach 11KA71163-56-06 with the A5547-127 event.
Eby teaches cells, tissue culture of the plant (claims 3-4), 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), F1 progeny seeds (claim 7), 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), 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), a method of using the plant to produce a different inbred soybean plant (claims 14-17), a method of mutagenizing the plant (claim 17), and methods of producing commodity products, including protein isolates, protein concentrate, hulls, meal, flour and oil (claims 18-19).
Eby claims 57160653 further comprising a single locus conversion (claim 13) and a method of making it by backcrossing (claim 11), including where the conversion confers herbicide resistance (claim 12). To understand the scope of those claims, Eby’s specification is reviewed below.
Eby defines a single locus conversion as follows (column 6, lines 16-24):
Single Locus Converted (Conversion). Single locus converted (conversion), also known as coisogenic plants, refers to plants which are developed by a plant breeding technique called backcrossing and/or by genetic transformation to introduce a given locus that is transgenic in origin, wherein essentially all of the morphological and physiological characteristics of a soybean variety are recovered in addition to the characteristics of the locus transferred into the variety via the backcrossing technique or by genetic transformation.
Eby tells us that converted plants produced by backcrossing will have essentially all of the morphological and physiological characteristics of the recurrent parent, in addition to the single transferred gene from the nonrecurrent parent (column 24, lines 29-35):
The resulting progeny from this cross are then crossed again to the recurrent parent and the process is repeated until a soybean plant is obtained wherein essentially all of the morphological and physiological characteristics of the recurrent parent are recovered in the converted plant, in addition to the single transferred gene from the nonrecurrent parent.
Eby provides a definition of “essentially all” in a paragraph where he tells us that converted plants will have “occasional variant traits” and are part of his invention (column 23, line 60, to column 24, line 10):
When the term "soybean plant" is used in the context of the present invention, this also includes any single gene conversions of that cultivar. The term single gene converted plant as used herein refers to those soybean plants which are developed by a plant breeding technique called backcrossing wherein essentially all of the morphological and physiological characteristics of a cultivar are recovered in addition to the single gene transferred into the cultivar via the backcrossing technique. By "essentially all" as used herein in the context of morphological and physiological characteristics it is meant that the characteristics of a plant are recovered that are otherwise present when compared in the same environment, other than occasional variant traits that might arise during backcrossing or direct introduction of a transgene. It is understood that a locus introduced by backcrossing may or may not be transgenic in origin, and thus the term backcrossing specifically includes backcrossing to introduce loci that were created by genetic transformation.
Eby further tells us backcross converted plants will have traits that vary from those of 57160653 (column 26, lines 34-41):
The modified soybean cultivar 57160653 may be further characterized as having the morphological and physiological characteristics of soybean cultivar 57160653 listed in Table 1 as determined at the 5% significance level when grown in the same environmental conditions and/or may be characterized by percent similarity or identity to soybean cultivar 57160653 as determined by SSR markers.
Eby tells us to introduce single locus conversions into 57160653 by backcrossing (column 25, lines 3-9):
Cultivar 57160653 represents a new base genetic cultivar into which a new locus or trait may be introgressed. Direct transformation and backcrossing represent two important methods that can be used to accomplish such an introgression. The term backcross conversion and single locus conversion are used interchangeably to designate the product of a backcrossing program.
Eby’s specification teaches that with the help of marker-assisted selection a backcross conversion can be made in as few as two backcrosses (column 25, lines 19-29).
Eby teaches that “it is understood by those of ordinary skill in the art that for single gene traits that are relatively easy to classify, the backcross method is effective and relatively easy to manage” (column 25, lines 35-38) and herbicide resistance conferred by a transgene is listed as such a trait (column 25, lines 40-57).
Eby does not teach 11KA71163-56-06 with the A5547-127 event.
Beuckleer teaches soybean plants with the A5547-127 event, which confers glufosinate tolerance without otherwise compromising agronomic performance (column 25, lines 1-36; column 26, lines 34-42).
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 into 11KA71163-56-06 by backcrossing. One of ordinary skill in the art would have been motivated to do so because doing so would confer an herbicide resistance to 11KA71163-56-06 that would allow it to survive in a field sprayed with glufosinate, in addition to glyphosate and/or dicamba, to control weeds. Additionally, Eby suggests introducing glufosinate resistance into the plant (column 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 (Beuckleer, column 25, lines 1-36; column 26, lines 34-42).
11KA71163-56-06 and the instant soybean have similar values for relative maturity, lodging, plant height, seeds/lb, and % seed oil and protein. These differences 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.
Further, in light of Eby’s specification discussed above, one of ordinary skill in the art would interpret Eby’s claims 11-13 as encompassing a backcrossing method with as few as two backcrosses, where the trait backcrossed in is herbicide resistance, and would interpret the single locus converted plant of Eby’s claim 13 as encompassing plants that are not invariant from 57160653’s traits, other than the conversion, but that differ from 57160653 to some undefined extent and have “occasional” variant traits relative to it.
Thus, one of ordinary skill in the art would have expected variant traits to be encompassed within the single locus converted plant claimed in Eby’s claim 13 or produced by Eby’s methods of claims 11 and 12. One of ordinary skill in the art would have expected the single locus converted plant to not be identical to 57160653 because Eby tells us that converted plants produced by backcrossing will have essentially all of the morphological and physiological characteristics of the recurrent parent, in addition to the single transferred gene from the nonrecurrent parent (column 24, lines 29-35), and that backcross converted plants will have traits that vary from those of 57160653 (column 26, lines 34-41).
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 11KA71163-56-06’s traits into other, new soybean lines.
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 11KA71163-56-06.
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 reasons farmers grow soybeans.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
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 Nos. US 11234405, US 11259495, US 11252923, US 11234406, and US 11206797. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the instant application and each of ‘405, ‘495, ‘923, ‘406, and ‘797 are patentably indistinct because the claims differ only in the name of the cultivars recited 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, tan pods, gray hila, 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 values for relative maturity, lodging, plant height, seeds/lb, and % seed oil and protein, as shown in the table below:
PNG
media_image1.png
298
881
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Greyscale
These small variations in these traits are what one of ordinary skill in the art would expect among progeny of a BC2F1 cross. As none of the traits distinguish the instant cultivar from those claimed in the patents listed above, these cultivars are not distinct and thus are obvious variants.
Claims 13 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/888,797.
Claim 13 of the instant application claims a soybean plant of soybean cultivar 04150104, 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 04150104. Claim 18 is drawn to a mutagenized soybean that comprises a mutation and otherwise comprises all the morphological and physiological characteristics of soybean cultivar 04150104.
The soybean cultivar claimed in ‘797 differs from the soybean cultivar claimed in the instant application in one trait controlled by a single gene, but that and the instant cultivar otherwise have yellow seed coats, a dull seed coat luster, yellow cotyledons, ovate leaflets, purple flowers, gray pubescence, 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. Both share parents 11KA71163-56-06 X (11KA71163-56-06(11KA71163-56-06 x OX3009B4-D0YN)) and were made by the same breeding steps. They also have similar values for the environmentally affected traits relative maturity, lodging, height, seeds/lb, seed % protein, and seed % oil.
The one single gene trait the soybean cultivars claimed in the instant application and in ‘399 differs in is hila color.
The soybean cultivar claimed in ‘797 is thus indistinguishable from a soybean plant of soybean cultivar 04150104 further comprising a single locus conversion or a mutation, wherein the plant comprises the single locus conversion or mutation and otherwise comprises all of the morphological and physiological characteristics of soybean cultivar 04150104.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of each of copending Application Nos. 19071635, 19071251, 18932315, 19006409, 19022639, 19006409, 19400152, 18776056, 18782861, 18829948, 18975903, 18979289, 18975863, 19003985, 18782869, 18822972, 18975975, 19003872, 18443271, 19097710, 19097723, 19097756, and 19097734. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the instant application and each of ‘635, ‘251, ‘315, ‘409, ‘639, ‘409, ‘152, ‘056, ‘861, ‘948, ‘903, ‘289, ‘863, ‘985, ‘869, ‘972, ‘975, ‘872, ‘271, ‘710, ‘723, ‘756, and ‘734 are patentably indistinct because he 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, tan pods, gray hila, 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 values for relative maturity, lodging, plant height, seeds/lb, and % seed oil and protein, as shown in the table below:
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media_image2.png
878
904
media_image2.png
Greyscale
These small variations in these traits are what one of ordinary skill in the art would expect among progeny of a BC2F1 cross. As none of the traits distinguish the instant cultivar from those claimed in the patents listed above, these cultivars are not distinct and thus are obvious variants.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,591,827 in view of U.S. Patent No. 8,017,756
The instant application claims soybean variety 04150104, methods of using it, and products and plants produced from it.
‘827 claims soybean variety (claims 1-2), which its specification teaches is another name for 11KA71163-56-06 (column 6, lines 43-44). ‘827 claims cells, tissue culture of the plant (claims 3-4), 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), F1 progeny seeds (claim 7), introducing transgenes 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, and plants thereby produced (claims 8-10), 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), a method of using the plant to produce a different inbred soybean plant (claims 14-17), a method of mutagenizing the plant (claim 17), and methods of producing commodity products, including protein isolates, protein concentrate, hulls, meal, flour and oil (claims 18-19).
Like the instant soybean, 11KA71163-56-06 is defined as having purple flowers, gray pubescence, tan pods, gray hila, 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. 11KA71163-56-06 and the instant soybean also have similar values for relative maturity, lodging, plant height, seeds/lb, and % seed oil and protein.
‘827 does not claim 11KA71163-56-06 with the A5547-127 event.
‘756 teaches soybean plants with the A5547-127 event, which confers glufosinate tolerance without otherwise compromising agronomic performance (column 25, lines 1-36; column 26, lines 34-42).
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 into 11KA71163-56-06 by backcrossing. One of ordinary skill in the art would have been motivated to do so because doing so would confer an herbicide resistance to 11KA71163-56-06 by that would allow it to survive in afield sprayed with glufosinate, in addition to glyphosate and/or dicamba, to control weeds. The A5547-127 event is one way to achieve that, with the advantage that it does not otherwise compromise agronomic performance (‘756, column 25, lines 1-36; column 26, lines 34-42).
The soybean claimed in ‘827 and the instantly claimed soybean have similar values for relative maturity, lodging, plant height, seeds/lb, and % seed oil and protein. These differences 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.
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 claimed in ‘827. 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 claimed in ‘827. 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 mutagenized the resulting soybean, as claimed in ‘827. One of ordinary skill in the art would have been motivated to do so because this would allow one to introduce new traits into 11KA71163-56-06.
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 claimed in ‘827. 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 soybean.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham, can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anne Kubelik/Primary Examiner, Art Unit 1663
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