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.
Deposit of Biological Material
This application requires public availability of soybean variety 5PMHB70 to make and use the claimed invention. A rejection under the appropriate sections of 35 USC 112 would have been made but for ¶195 in the specification 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(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 5PMHB70, 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 5PMHB70, 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 5PMHB70”.
It is unclear what plants are encompassed by “soybean variety 5PMHB70” 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 5PMHB70” and that “soybean variety 5PMHB70” 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 5PMHB70 would be is completely unclear, especially since the loci are converted relative to the undefined genus “5PMHB70”.
The specification does not define “mutation”, but states that “[m]utation breeding is another method of introducing new traits into soybean variety 5PMHB70 or a soybean variety having all of the morphological and physiological characteristics of 5PMHB70” (¶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 5PMHB70”.
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 5PMHB70”.
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 5PMHB70 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 5PMHB70” that must remain unaltered to be a soybean of “variety 5PMHB70”.
Therefore, given the definition of “variety” in the specification, and the examples found in the specification as set forth, above, plants of “variety 5PMHB70” 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 5PMHB70.
All of this background in the specification renders the metes and bounds of “variety 5PMHB70” 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 5PMHB70, 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 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 5PMHB70, 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 5PMHB70” are completely unclear. It is clear that “variety 5PMHB70” 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 5PMHB70. 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 5PMHB70. Again, the “a” before “locus conversion” means one or more (¶194).
As discussed in the rejection under 35 USC 112(b) above, “soybean variety 5PMHB70” 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 5PMHB70”, 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 5PMHB70” from other soybean plants.
The specification describes no structural features that distinguish plants of “soybean variety 5PMHB70” comprising any number of locus conversions from other soybean plants or from plants of soybean variety 5PMHB70 themselves.
Hence, Applicant has not, in fact, described plants of “soybean variety 5PMHB70” or plants of “soybean variety 5PMHB70” 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 §§ 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
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. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Fabrizius et al et al (2019, US 10,257,993).
The claims are drawn to a plant or a seed, plant parts, of soybean variety 5PMHB70 or plants and plant parts derived from said variety, and methods that utilize said variety.
Fabrizius et al teaches soybean 5PYQB84, which the instant specification indicates is a grandparent of soybean variety 5PMHB70 (¶196),
Like the plant described in the instant Table 1, 5PYQB84 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 scores for canopy width, height/maturity, resistance to brown stem rot, cyst nematode race 3, and frogeye leaf spot.
The plants have only small differences in quantitative traits like relative maturity, harvest standability, emergence, iron chlorosis, Phytophthora filed tolerance, resistance to white mold and charcoal rot, and oil and protein percentages. The plants differ in resistance to glufosinate, 2,4 D, and cyst nematode race 14.
Note that in both Fabrizius et al 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 Fabrizius et al’s definitions starting on column 1, line 57, and those in the instant specification ¶6 - ¶113.
Given the instant definition of “variety” (¶114), the instantly claimed “soybean variety 5PMHB70” encompasses broad genus of plants that have some unspecified amount of genetics and/or physiological and morphological traits in common.
Fabrizius et al’s 5PUQS80 appears to be a plant within the genus of plants of “soybean variety 5PMHB70”. Any differences, like amount of white mold or charcoal rot resistance or the absence of resistance to glufosinate, 2,4 D, and cyst nematode race 14, appear to merely be the locus conversions, mutations, or somaclonal variants encompassed by the instant definition of “variety” (¶114).
Therefore, given the current record, the prior art soybean taught by Fabrizius et al is indistinguishable from or a species of the currently claimed soybean variety, especially given the breadth encompassed by the definition of the term “variety” that is discussed, above, in the rejection under 35 USC 112b.
Fabrizius et al’s claims 1-5, 7, 10-15, and 18 are identical to the instant claims 1-6, 8-13, and 19, respectively, except for the name of the variety. As 5PUQS80 appears to be a plant within the genus of plants of the instantly claimed “soybean variety 5PMHB70”, those claims anticipate the instant claims 1-6, 8-13, and 19, respectively.
Fabrizius et al teaches mutagensis of 5PUQS80, including by gamma radiation (column 31, lines 5-32), thus anticipating instant claim 7.
It would be obvious to one of ordinary skill in the art for the herbicide resistance in Fabrizius et al’s claim 14 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 to genome edit 5PUQS80 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 5PUQS80 or 5PUQS80 with a locus conversion, as products like soybean oil and soybean meal are common and economically important uses of soybean seed. Thus, instant claim 17 is obvious.
5PUQS80 is a plant with all of the physiological and morphological characteristics of 5PMHB70, as it falls within the genus of plants of the instantly claimed “soybean variety 5PMHB70”. Thus, instant claim 18 is anticipated.
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 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/589,982. Although the claims at issue are not identical, they are not patentably distinct from each other.
‘982 claims soybean variety 5PGBU05, which, like instant soybean variety 5PMHB70, was produced by backcrossing a locus conferring glyphosate, glufosinate, and 2,4-D tolerance into a variety produced from a cross between 5PYQB84 and 5PLAY23. Like the instant soybean variety, 5PGBU05 has purple flowers, light tawny pubescence, brown pods, an indeterminate growth habit, yellow seed coats, the 1K Phytophthora resistance gene, resistance to glyphosate, glufosinate, and 2,4-D, and the same scores for canopy width, height/maturity, and resistance to frogeye leaf spot, brown stem rot, and cyst nematode races 3 and 14. The plants have only small differences in some of the quantitative traits like relative maturity, grams per 1000 seeds, Phytophthora field tolerance, yield per acre, harvest standability, field emergence, iron deficiency chlorosis, resistance to sudden death, white mold, and charcoal rot, oil and protein content, and seed size. 5PGBU05 and the instant soybean differ in hila color.
Given the instant definition of “variety” (¶114), the instantly claimed “soybean variety 5PMHB70” encompasses broad genus of plants that have some unspecified amount of genetics and/or physiological and morphological traits in common. Thus, 5PGBU05 appears to be a plant within the genus of plants that are 5PMHB70 and/or a locus-converted or edited plant of 5PMHB70.
‘982’s claims are identical to the instant claims except for the name of the variety.
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 copending Application No. 18/590,000. Although the claims at issue are not identical, they are not patentably distinct from each other.
‘000 claims soybean variety 5PGMA95, which, like instant soybean variety 5PMHB70, was produced by backcrossing a locus conferring glyphosate, glufosinate, and 2,4-D tolerance into a variety produced from a cross between 5PYQB84 and 5PLAY23. Like the instant soybean variety, 5PGMA95 has purple flowers, light tawny pubescence, brown pods, an indeterminate growth habit, yellow seed coats, the 1K Phytophthora resistance gene, resistance to glyphosate, glufosinate, and 2,4-D, and the same scores for field emergence, resistance to cyst nematode race 14, sudden death, brown stem rot, and frogeye leaf spot, and canopy width. The plants have only small differences in some of the quantitative traits like relative maturity, grams per 1000 seeds, Phytophthora field tolerance, yield per acre, harvest standability, iron deficiency chlorosis, resistance to white mold, charcoal rot, and cyst nematode race 3, height/maturity, oil and protein content, and seed size. 5PGMA95 and the instant soybean differ in hila color.
Given the instant definition of “variety” (¶114), the instantly claimed “soybean variety 5PMHB70” encompasses broad genus of plants that have some unspecified amount of genetics and/or physiological and morphological traits in common. Thus, 5PGMA95 appears to be a plant within the genus of plants that are 5PMHB70 and/or a locus-converted or edited plant of 5PMHB70.
‘000’s claims are identical to the instant claims except for the name of the variety.
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 1-20 of U.S. Patent No. 10,257,993. Although the claims at issue are not identical, they are not patentably distinct from each other.
‘993 claims soybean 5PYQB84, which the instant specification indicates is a grandparent of soybean variety 5PMHB70 (¶196),
Like the plant described in the instant Table 1, 5PYQB84 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 scores for canopy width, height/maturity, resistance to brown stem rot, cyst nematode race 3, and frogeye leaf spot.
The plants have only small differences in quantitative traits like relative maturity, harvest standability, emergence, iron chlorosis, Phytophthora filed tolerance, resistance to white mold and charcoal rot, and oil and protein percentages. The plants differ in resistance to glufosinate, 2,4 D, and cyst nematode race 14.
Note that in both ‘993 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 ‘993’s definitions starting on column 1, line 57, and those in the instant specification ¶6 - ¶113.
Given the instant definition of “variety” (¶114), the instantly claimed “soybean variety 5PMHB70” encompasses broad genus of plants that have some unspecified amount of genetics and/or physiological and morphological traits in common.
‘993’s 5PUQS80 appears to be a plant within the genus of plants of “soybean variety 5PMHB70”. Any differences, like amount of white mold or charcoal rot resistance or the absence of resistance to glufosinate, 2,4 D, and cyst nematode race 14, appear to merely be the locus conversions, mutations, or somaclonal variants encompassed by the instant definition of “variety” (¶114).
Therefore, given the current record, the prior art soybean claimed in ‘993 is indistinguishable from or a species of the currently claimed soybean variety, especially given the breadth encompassed by the definition of the term “variety” that is discussed, above, in the rejection under 35 USC 112b.
‘993’s claims 1-5, 7, 10-15, and 18 are identical to the instant claims 1-6, 8-13, and 19, respectively, except for the name of the variety. As 5PUQS80 appears to be a plant within the genus of plants of the instantly claimed “soybean variety 5PMHB70”, those claims anticipate the instant claims 1-6, 8-13, and 19, respectively.
It would be obvious to one of ordinary skill in the art mutagenize 5PUQS80, 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 for the herbicide resistance in ‘993’s claim 14 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 to genome edit 5PUQS80 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 5PUQS80 or 5PUQS80 with a locus conversion, as products like soybean oil and soybean meal are common and economically important uses of soybean seed. Thus, instant claim 17 is obvious.
5PUQS80 is a plant with all of the physiological and morphological characteristics of 5PMHB70, as it falls within the genus of plants of the instantly claimed “soybean variety 5PMHB70”. Thus, instant claim 18 is anticipated.
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.
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/Anne Kubelik/Primary Examiner, Art Unit 1663