DETAILED ACTION
Claims 1-20 are pending and are examined in the present office action.
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 for using the non-metric units bushel and acre in ¶15, ¶115, and Table 1 and inches in ¶42. Metric units should be used in patent applications. See MPEP 608.01 IV.
Claim Rejections - 35 USC § 112
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. Dependent claims are included in all rejections.
Claims 1 and 4 are indefinite in their recitation of “soybean variety 5PEDZ12, representative seed of the variety having been deposited under NCMA Accession Number XXXX”, claim 18 is indefinite in its recitation of “the soybean plant of claim 2, representative seed of the variety having been deposited under NCMA Accession Number XXXX”, claim 19 is indefinite in its recitation of “soybean variety 5PEDZ12, representative seed of the soybean variety having been deposited under NCMA Accession Number XXXX”, and claims 4, 7, 13, and 16 are indefinite in their recitation of “soybean variety 5PEDZ12”.
It is unclear what plants are encompassed by “soybean variety 5PEDZ12” because of the specification’s definition of the word “variety”.
The specification defines the word “variety” as follows (¶114):
[0114] VARIETY. A substantially homozygous soybean line and minor modifications thereof that retains the overall genetics of the soybean line including but not limited to a subline, a locus conversion, a mutation, a transgenic, or a somaclonal variant. Variety includes seeds, plants, plant parts, and/or seed parts of the instant soybean line.
There is no definition in the specification for “substantially homozygous soybean line”. Presumably “homozygous” refers to genes being homozygous as opposed to heterozygous, but it is unclear what level of homozygousity is considered “substantial” and how many genes in a plant are permitted to be heterozygous and the plant still being part of the variety. If “homozygous” does not refer to genes being homozygous, it is unclear what the term means in the context of the definition and claim.
It is unclear what is meant by “retains the overall genetics of the soybean line”. It is not clear what level of variation is permitted for a plant to retain the overall genetics of the soybean line and it is not clear the boundary to not retaining the overall genetics of the soybean line is crossed.
However, it appears from the remainder of the definition of “variety” that a large amount of variation is encompassed by “soybean variety 5PEDZ12” and that “soybean variety 5PEDZ12” encompasses a genus of plants.
The specification defines “locus conversion” as follows (¶61):
[0061] LOCUS CONVERSION. Refers to seeds, plants, and/or parts thereof developed by backcrossing or genetic transformation wherein essentially all of the desired morphological and physiological characteristics of a variety are recovered in addition to at least one locus which has been transferred into the variety by introgression, backcrossing or genetic transformation. The locus can be a native locus, a transgenic locus, or a combination thereof.
This definition indicates that a locus conversion involves the introduction of a locus, i.e., gene(s), into the plant.
The specification defines “essentially all of the phenotypic characteristics or morphological and physiological characteristics” as follows (¶147):
By essentially all of the phenotypic characteristics or morphological and physiological characteristics, it is meant that all of the characteristics of a plant are recovered that are otherwise present when compared in the same environment, other than an occasional variant trait that might arise during backcrossing or direct introduction of a transgene or specific genetic modification.
The specification does not indicate how a “occasional variant”, which by the use of the word “occasional” is something that happens at some times and not at other times, applies to a product, i.e., the claimed plant. The specification also does not indicate how many of these “occasional variants” are encompassed.
The specification provides the following nonlimiting discussion of locus conversions (¶137):
A single locus conversion may contain several transgenes or modifications, such as a transgene or modification for disease resistance and for herbicide resistance. … At least one, at least two or at least three and less than ten, less than nine, less than eight, less than seven, less than six, less than five or less than four locus conversions may be introduced into the plant by backcrossing, introgression or transformation to express the desired trait, while the plant, or a plant grown from the seed, plant part or plant cell, otherwise retains the phenotypic characteristics of the deposited seed when grown under the same environmental conditions.
This allows for an unlimited number of changed loci, and clearly contemplates nine changed loci (i.e., “less than ten”), and it allows for an unlimited number of genes at each converted locus (i.e., “multiple genes”). The metes and bounds of what a “locus conversion” of 5PEDZ12 would be is completely unclear, especially since the loci are converted relative to the undefined genus “5PEDZ12”.
The specification does not define “mutation”, but states that “[m]utation breeding is another method of introducing new traits into soybean variety 5PEDZ12 or a soybean variety having all of the morphological and physiological characteristics of 5PEDZ12” (¶170).
This definition indicates that a mutation involves changing the genes in the plant. It is unclear how many mutations can be introduced and which characteristics can be changed by mutation and continue to be covered by the instant label of “variety 5PEDZ12”.
The specification does not define “transgenic”, but it can also be interpreted as changing or adding to the genes in the plant.
The specification provides no definition of “somaclonal variant”, but the word “variant” indicates that genes in the plant have been changed in some manner.
The specification defines “a” and “an” as follows (¶194):
The indefinite articles "a" and "an" preceding an element or component are nonrestrictive regarding the number of instances (i.e., occurrences) of the element or component. Therefore "a" or "an" should be read to include one or at least one, and the singular word form of the element or component also includes the plural unless the number is obviously meant to be singular.
Thus, multiple locus conversions, mutations, transgenes, and somaclonal variants are encompassed by the definition of “variety”. It is not clear how many of these it takes for the plant to no longer be a member of the genus of plants named “soybean variety 5PEDZ12”.
Thus, it appears that the variety includes loci converted relative to its own loci and mutations relative to its own genome, and variations relative to its own genetic background. This is circular logic and renders this definition meaningless.
Lastly, the specification defines subline as follows (¶111):
[0111] SUBLINE. Although 5PEDZ12 contains substantially fixed genetics, and is phenotypically uniform and with no off-types expected, there still remains a small proportion of segregating loci either within individuals or within the population as a whole. The segregating loci both within any individual plant and/or the population can be used to extract unique varieties (sublines) with similar phenotype but improved agronomics.
It is unclear what inbred population this “subline” would be derived from.
Note that the definition of a subline indicates that a variety is subline and that the definition of a variety indicates that a subline is a species of the genus of plants encompassed by a variety. This circular definition makes it competently unclear how these differ and how much variation is encompassed by both of these terms.
It is not clear if there are any traits or genes that are essential to “variety 5PEDZ12” that must remain unaltered to be a soybean of “variety 5PEDZ12”.
Therefore, given the definition of “variety” in the specification, and the examples found in the specification as set forth, above, plants of “variety 5PEDZ12” are inclusive of sublines, locus conversions, mutants, transgenic versions of a starting plant, and somaclonal variants of a starting plant. Members of the variety could have an unlimited number of locus conversions introduced, and paragraph 137 clearly envisions and contemplates “less than ten” as one embodiment. Each converted locus may contain “multiple genes” with no limit as to how many genes can be inserted into a “single locus conversion”. Plants encompassed by the variety name may be further characterized as having all or essentially all of the phenotypic characteristics or morphological and physiological characteristics of variety 5PEDZ12.
All of this background in the specification renders the metes and bounds of “variety 5PEDZ12” unclear. It is clear that “variety” is defined as including sublines, locus conversions, mutants, transgenic versions of a starting plant, and somaclonal variants of a starting plant, but the further discussions in the specification have percent identity or characteristic comparisons relative to the variety itself. This is circular logic that renders the metes and bound of the variety name indefinite. For example, there is a description of the variety in Table 1. Is the variety inclusive of plants that have conversions, mutations, and variations relative to the plants described in this table? If so, how many changes relative to this Table are allowed?
Claims 1, 4, and 18-19 recite “representative seed of the … variety having been deposited under NCMA Accession Number XXXX”. It is unclear how the seed is “representative”. It is clear that the “variety” encompasses all kinds of genetic and phenotypic changes, perhaps these changes are relative to a plant grown from one of the deposited seeds, but it is unclear in what way the seeds that will be deposited are “representative” of the variety because it is unclear what is required to remain constant and unchanged.
Claim 18 is indefinite in its recitation of “A soybean plant expressing all the physiological and morphological characteristics of the soybean plant of claim 2”. Given the wide variation encompassed by a plant produced by growing seed of soybean variety 5PEDZ12, as “variety” is defined in the specification, it is not clear what physiological and morphological characteristics the plant of claim 18 has.
Claim 15 lacks antecedent basis for the limitation “the seed, plant, plant part, or plant cell of claim 1” as claim 1 is only drawn to a plant or seed.
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.
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.
The claims all require seed of soybean variety 5PEDZ12.
Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public.
The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. So long as the number of seeds deposited complies with the requirements of the IDA where the deposit is made, the USPTO considers such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809.
It is noted that Applicant intends to deposit seeds for 5PEDZ12 at the NCMA (¶195), but there is no indication that the seeds have been deposited. Further, there is no affirmative statement in the specification that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
If the deposit of these seeds is made and accepted under the terms of the Budapest Treaty, then 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.
If the deposit is not made and/or accepted under the Budapest Treaty, then 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; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
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 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 instant claims are broadly drawn to plants and seeds of soybean variety 5PEDZ12, and plants and seed derived from said variety, and methods of using said variety.
As discussed above in the indefiniteness rejection, the specification provides such a broad definition of “variety” that the metes and bounds of what soybeans would be covered by “variety 5PEDZ12” are completely unclear. It is clear that “variety 5PEDZ12” at least includes sublines, locus conversions, mutants, transgenic versions of a starting plant, and somaclonal variants of a starting plant, and this encompasses an unlimited number of changes to the genome and to the phenotypes and characteristics of the plants.
It is known in the art that treating seeds with chemical mutagens such as EMS can lead to multitudes of mutations within the genome. In one experiment treating soybeans with EMS, the average number of base changes per line was 12,796 changes (Tsuda et al, 2015, BMC Genomics 16:1-18; see abstract). Mutations in soybean resulted in phenotypic changes in tall, dwarf, stunted, early and late flowering, early and late maturity, green color seed, wrinkled seed, single seeded pod, long pod, tetra foliate leaf, and male sterility (Pavadai et al, 2009, J. of Phytology 1:444-447; see pg 445, right column, paragraph 2), in protein and oil content (Pavadai et al, Table 2), in seed germination, seedling survival, chlorophyll, leaves, height, growth type (including lodging), maturity, pod number, pod setting, yield (including seed size), protein/oil content, and disease resistance (Khan et al, 2013, J. of Cereals Oilseeds 4:19-25, see pg 20, left column, paragraph 2, to pg 23, left column, paragraph 4). These changes could alter most of the traits listed in Table 1 as the description for the instant cultivar (seed color, leaflet shape, maturity group, relative maturity, lodging/standability, height, seed size, protein, and oil). “An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function.” MPEP 2163 I A.
Furthermore, the instant specification does not have a single embodiment of a plant produced by mutating the instant cultivar, inducing somaclonal variation into the cultivar, introducing a locus conversion, identifying a subline, or introducing a transgene actually reduced to practice. Given that the underlying genetics can be dramatically changed with thousands of base changes, rearrangement, or substitutions in the genomic DNA, and the phenotypic, physiological and morphological characteristics can be changed due to multiple changes in traits as a result of the mutations, variations, conversions, or transgenes, the genus of mutant plants encompassed by claims is not adequately described.
Further claims 13-14 are drawn to plants comprising a locus conversion of soybean variety 5PEDZ12. The definition of “locus conversion” in ¶61 indicates one or more locus conversions are encompassed, and the recitation “a” before “locus conversion” means one or more (¶194).
Claim 16 is drawn to a modified soybean variety comprising a genome edit and otherwise comprises all of the physiological and morphological characteristics of soybean variety 5PEDZ12. Again, the “a” before “locus conversion” means one or more (¶194).
As discussed in the rejection under 35 USC 112(b) above, “soybean variety 5PEDZ12” encompasses a plant with an unspecified number of locus conversions. The plants of claims 13-14 and 16 can have any number of locus conversions or edits relative to “soybean variety 5PEDZ12”, i.e., they can have any number of locus conversions or edits relative to a plant that can have any number of locus conversions.
The specification describes no structural features that distinguish plants of “soybean variety 5PEDZ12” from other soybean plants.
The specification describes no structural features that distinguish plants of “soybean variety 5PEDZ12” comprising any number of locus conversions from other soybean plants or from plants of soybean variety 5PEDZ12 themselves.
Hence, Applicant has not, in fact, described plants of “soybean variety 5PEDZ12” or plants of “soybean variety 5PEDZ12” comprising a locus conversion, 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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claims 1-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Carden et al (2015, US 8,946,519) in view of Mason (2020, US 10,667,483).
The claims are drawn to a plant or a seed, plant parts, of soybean variety 5PEDZ12 or plants and plant parts derived from said variety, and methods that utilize said variety. The claims are interpreted as discussed in the rejection under 35 USC 112(b) above and incorporated herein.
‘519 teaches soybean variety XB24N13. Like the plant described in the instant Table 1, XB24N13 has purple flowers, light tawny pubescence, black hila, brown pods, an indeterminate growth habit, yellow seed coats, the 1K Phytophthora resistance gene, and resistance to glyphosate (Table 1). The two plants have the same or similar scores for relative maturity, harvest standability, emergence, iron chlorosis, white mold, cyst nematode races 3 and 14, % protein, and % oil.
Note that in both ‘519 and the instant specification, “Preliminary scores are reported as double digits, for example ‘55’ indicates a preliminary score of 5 on the scale of 1 to 9”. See throughout’842’s definitions starting on column 2, line 38, and those in the instant specification ¶6 - ¶113.
‘519 does not teach XB24N13 with a single event that confers resistance to glyphosate, glufosinate and 2,4-D, with brown pods, or with moderate charcoal rot resistance.
Mason teaches a soybean cultivar with the DAS-44406-6 event, which confers resistance to glyphosate, glufosinate and 2,4-D (Table 1, column 7, lines 9-18).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify XB24N13 taught in ‘519 to replace its glyphosate resistance with a single event conferring resistance to glyphosate, glufosinate and 2,4-D. One of ordinary skill in the art would have been motivated to do so because this event also confers resistance to glufosinate, this giving the resulting plants resistance to a broader spectrum of herbicides. All of glyphosate, glufosinate and 2,4-D are herbicides commonly used by farmers to control weeds.
Any other differences between a plant produced by introducing the DAS-44406-6 event into XB24N13 and the instant plant are obvious variants produced by growing the plants in different environments. Additionally, given the instant definition of “variety” (¶114), the instantly claimed “soybean variety 5PEDZ12” encompasses broad genus of plants that have some unspecified amount of genetics and/or physiological and morphological traits in common. Differences in brown color and charcoal rot resistance are among these.
‘519’s claim 1 claims plants, plant parts, and seeds, while the instant claim 1 only claims plants and seeds; otherwise the claims differ only in the name of the variety.
‘519’s claims 2, 14-15, 17, 4-5, 3, 8 and 19 are identical to the instant claims 2, 4-6, 8-10, 12, and 19, respectively, except for the name of the variety. ‘519’s claims 9-12 are species of the genus of the instant claim 13.
It would be obvious to one of ordinary skill in the art for the herbicide resistance in ‘519’s claim 9 to be toward a sulfonylurea herbicide, dicamba, glufosinate, glyphosate, 2,4-dichlorophenoxyacetic acid (2,4-D), an acetolactate synthase-inhibiting herbicide, or a protoporphyrinogen oxidase inhibiting herbicide, as these were common herbicides and herbicide resistances at the time of filing. Thus, the instant claim 14 is obvious.
‘519 teaches mutagensis of XB24N13, including by gamma radiation (column 27, line 46, to column 28, line 5). It would be obvious to one of ordinary skill in the art to mutagenize the plant produced by introducing the DAS-44406-6 event into XB24N13 to generate a plant with new traits, thus rendering instant claim 7 obvious.
‘519 teaches treating seeds of XB24N13 (column 30, line 43, to column 31, line 15). It would be obvious to one of ordinary skill in the art to do so to seed produced by introducing the DAS-44406-6 event into XB24N13 to protect it from pests and diseases, thus rendering instant claim 3 obvious.
It would be obvious to one of ordinary skill in the art to isolate nucleic acids from the plant, as part of applying plant breeding techniques to the F1 progeny of plant. Marker assisted selection is a common plant breeding technique and involves comparing marks in parents and progeny.
It would be obvious to one of ordinary skill in the art to genome edit the plant produced by introducing the DAS-44406-6 event into XB24N13 to alter a trait or as an alternative way to produce a locus conversion. Thus, instant claims 15-16 are obvious.
It would be obvious to one of ordinary skill in the art to produce a commodity plant product from the plant produced by introducing the DAS-44406-6 event into XB24N13, as products like soybean oil and soybean meal are common and economically important uses of soybean seed. Thus, instant claim 17 is obvious.
The plant produced by introducing the DAS-44406-6 event into XB24N13 is a plant with all of the physiological and morphological characteristics of 5PAGD7. Thus, instant claim 18 is obvious.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 8.946,519 in view of Mason (2020, US 10,667,483).
The claims are drawn to a plant or a seed, plant parts, of soybean variety 5PEDZ12 or plants and plant parts derived from said variety, and methods that utilize said variety. The claims are interpreted as discussed in the rejection under 35 USC 112(b) above and incorporated herein.
‘519 claims soybean variety XB24N13. Like the plant described in the instant Table 1, XB24N13 has purple flowers, light tawny pubescence, black hila, an indeterminate growth habit, yellow seed coats, the 1K Phytophthora resistance genes, and resistance to glyphosate (Table 1). The two plants have the same or similar scores for relative maturity, harvest standability, emergence, iron chlorosis, sudden death syndrome, cyst nematode races 3 and 14, % protein, and % oil.
Note that in both ‘519 and the instant specification, “Preliminary scores are reported as double digits, for example ‘55’ indicates a preliminary score of 5 on the scale of 1 to 9”. See throughout’842’s definitions starting on column 2, line 38, and those in the instant specification ¶6 - ¶113.
‘519 does not claim XB24N13 with a single event that confers resistance to glyphosate, glufosinate and 2,4-D, with brown pods, or with moderate charcoal rot resistance.
Mason teaches a soybean cultivar with the DAS-44406-6 event, which confers resistance to glyphosate, glufosinate and 2,4-D (Table 1, column 7, lines 9-18).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify XB24N13 taught in ‘519 to replace its glyphosate resistance with a single event conferring resistance to glyphosate, glufosinate and 2,4-D. One of ordinary skill in the art would have been motivated to do so because this event also confers resistance to glufosinate, this giving the resulting plants resistance to a broader spectrum of herbicides. All of glyphosate, glufosinate and 2,4-D are herbicides commonly used by farmers to control weeds.
Any other differences between a plant produced by introducing the DAS-44406-6 event into XB24N13 and the instant plant are obvious variants produced by growing the plants in different environments. Additionally, given the instant definition of “variety” (¶114), the instantly claimed “soybean variety 5PEDZ12” encompasses broad genus of plants that have some unspecified amount of genetics and/or physiological and morphological traits in common. Differences in brown color and charcoal rot resistance are among these. This includes any difference in pod color or charcoal rot resistance.
‘519’s claim 1 claims plants, plant parts, and seeds, while the instant claim 1 only claims plants and seeds; otherwise the claims differ only in the name of the variety.
‘519’s claims 2, 14-15, 17, 4-5, 3, 8 and 19 are identical to the instant claims 2, 4-6, 8-10, 12, and 19, respectively, except for the name of the variety. ‘519’s claims 9-12 are species of the genus of the instant claim 13.
It would be obvious to one of ordinary skill in the art for the herbicide resistance in ‘519’s claim 9 to be toward a sulfonylurea herbicide, dicamba, glufosinate, glyphosate, 2,4-dichlorophenoxyacetic acid (2,4-D), an acetolactate synthase-inhibiting herbicide, or a protoporphyrinogen oxidase inhibiting herbicide, as these were common herbicides and herbicide resistances at the time of filing. Thus, the instant claim 14 is obvious.
It would be obvious to one of ordinary skill in the art mutagenize the plant produced by introducing the DAS-44406-6 event into XB24N13, including by gamma radiation, as a way to produce a locus conversion, thus rendering instant claim 7 obvious.
It would be obvious to one of ordinary skill in the art to treat seeds produced by introducing the DAS-44406-6 event into XB24N13. It would be obvious to one of ordinary skill in the art to do so to seed to protect it from pests and diseases, thus rendering instant claim 3 obvious.
It would be obvious to one of ordinary skill in the art to isolate nucleic acids from the plant, as part of applying plant breeding techniques to the F1 progeny of plant. Marker assisted selection is a common plant breeding technique and involves comparing marks in parents and progeny.
It would be obvious to one of ordinary skill in the art to genome edit the plant produced by introducing the DAS-44406-6 event into XB24N13 to alter a trait or as an alternative way to produce a locus conversion. Thus, instant claims 15-16 are obvious.
It would be obvious to one of ordinary skill in the art to produce a commodity plant product from the plant produced by introducing the DAS-44406-6 event into XB24N13, as products like soybean oil and soybean meal are common and economically important uses of soybean seed. Thus, instant claim 17 is obvious.
The plant produced by introducing the DAS-44406-6 event into XB24N13 is a plant with all of the physiological and morphological characteristics of 5PAGD7. Thus, instant claim 18 is obvious.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/589/948. Although the claims at issue are not identical, they are not patentably distinct from each other.
‘948 claims soybean variety 5PNKV67. Like the plant described in the instant Table 1, 5PNKV67 has purple flowers, light tawny pubescence, black hila, an indeterminate growth habit, yellow seed coats, the 1K Phytophthora resistance genes, and an event that confers resistance to glyphosate, 2,4-D, and glufosinate (Table 1). The two plants have the same or similar scores for relative maturity, harvest standability, emergence, iron chlorosis, canopy width, height/maturity, sudden death syndrome, charcoal rot, brown stem rot, white mold, frogeye leaf spot, cyst nematode races 3 and 14, % protein, and % oil.
Thus, the instant plant and 5PNKV67 appear to be the same or obvious over one another.
The claims of ‘948 are the same as the instant application, except for the same of the variety.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/Anne Kubelik/Primary Examiner, Art Unit 1663