DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-20 are pending.
Claims 1-20 are examined in this Office action.
Information Disclosure Statement
Initialed and dated copy of Applicant’s information disclosure statement (IDS) filed on
04/15/2025 is attached to the instant Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: the Specification has missing seed deposit information in paragraph 0195 on page 59.
Appropriate correction is required.
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.
Indefiniteness
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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-20 are indefinite for including blank spaces denoted as “XXXX”. The claims are also indefinite in the recitation of 5PFLN03 because the name does not clearly identify the claimed soybean variety, seed and plant and does not set forth the metes and bounds of the claimed invention. Since the name of 5PFLN03 is not known in the art, the use of said name does not carry art recognized limitation as to the specific characteristics or essential characteristics that are associated with denomination. In addition, the name appears to be arbitrarily assigned and the specific characteristics associated therewith could be modified, as there is no written description of the soybean plant that encompasses all of its traits. To overcome this aspect of the indefiniteness rejection, Applicant should amend Claims 1, 4, 18, and 19 to recite, for example, the complete accession number for soybean variety 5PFLN03.
Claims 1, 4, and 19 are indefinite in their recitation of “soybean variety 5PFLN03, 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”, and Claims 4, 7, 13, 16, and 17 are indefinite in their recitation of “soybean variety 5PFLN03”.
It is unclear what plants are encompassed by “soybean variety 5PFLN03” because of the specification’s definition of the word “variety”.
The specification defines the word “variety” as follows (paragraph 114):
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 homozygosity is considered “substantial” and how many genes in a plant are permitted to be heterozygous for 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 also not clear when the boundary of 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 5PFLN03” and that “soybean variety 5PFLN03” encompasses a genus of plants.
The specification defines “locus conversion” as follows (paragraph 0061):
[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 (paragraph 0147):
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 an “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 (paragraph 0137):
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 5PFLN03 would be is completely unclear, especially since the loci are converted relative to the undefined genus “5PFLN03”, which itself encompasses locus conversions.
The specification does not define “mutation”, but states that “[m]utation breeding is another method of introducing new traits into soybean variety 5PFLN03 or a soybean variety having all of the morphological and physiological characteristics of 5PFLN03” (paragraph 0170).
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 5PFLN03”.
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 (paragraph 0194):
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 5PFLN03”.
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 (paragraph 111):
SUBLINE. Although 5PFLN03 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 a 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 5PFLN03” that must remain unaltered to be a soybean of “variety 5PFLN03”.
Therefore, given the definition of “variety” in the specification, and the examples found in the specification as set forth, above, plants of “variety 5PFLN03” 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 0137 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 5PFLN03.
All of this background in the specification renders the metes and bounds of “variety 5PFLN03” 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, 18, and 19 recite “representative seed of the variety having been deposited under NCMA Accession Number XXXX”. It is unclear how the seed is “representative”. As “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 deposited seeds 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 5PFLN03, as “variety” is defined in the specification, it is not clear what physiological and morphological characteristics the plant of claim 18 has.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Enablement
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 invention appears to employ novel soybean plants. Since the plant 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. If the plant is not so obtainable or available, a deposit of seed thereof may satisfy the requirements of 35 U.S.C. 112. A deposit of 650 seeds of each of the claimed invention is considered sufficient to ensure public availability. 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. It is noted that Applicant intends to deposit seed of soybean variety 5PFLN03 (pg. 59, paragraph 0195). However, 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 under the terms of the Budapest Treaty, then a statement, an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the seeds has been deposited and accepted, and 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. A minimum deposit of 625 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit, meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, an affidavit or declaration, or by someone empowered to make the same, 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 in accordance with 37 CFR 1.808(a)(2):;
(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 effective life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Written Description
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.
Claims 1-20 are broadly drawn to plants and seeds of soybean variety 5PFLN03, 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 5PFLN03” are completely unclear. It is clear that “variety 5PFLN03” 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 12-14 are drawn to plants comprising fewer than six locus conversions and otherwise all the morphological and physiological characteristics of soybean variety 5PFLN03.
“Soybean variety 5PFLN03” is interpreted as detailed in the 112b and written description rejections above.
As discussed in the rejection under 35 USC 112(b) above, “soybean variety 5PFLN03” encompasses a plant with an unspecified number of locus conversions, mutations, or somaclonal variants. The plants of claims 12-14 can have fewer than six locus conversions relative to “soybean variety 5PFLN03”, i.e., they can have fewer than six locus conversions relative to a plant that can have any number of locus conversions, mutations or somaclonal variants.
The specification describes no structural features that distinguish plants of “soybean variety 5PFLN03” from other soybean plants.
The specification describes no structural features that distinguish plants of “soybean variety 5PFLN03” comprising any number of locus conversions from other soybean plants or from plants of soybean variety 5PFLN03 themselves.
Hence, Applicant has not, in fact, described plants of “soybean variety 5PFLN03” or plants of “soybean variety 5PFLN03” comprising fewer than six locus conversions, 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.
Summary
No claim is allowed.
Claims 1-20 appear to be provisionally free of the prior art, given the failure of the prior art to teach or suggest a soybean plant having all of the morphological and physiological characteristics of the claimed soybean variety 5PFLN03.
The closest prior art in regard to Claims 1-20 can be found in HAYES (Hayes et al., US Patent No. 11,219,181 B1, issued 01/11/2022) which teaches soybean variety designated 5PLDE25, sharing many traits in common (or does not significantly differ) with instant soybean variety 5PFLN03 including: herbicide resistance spectrum, plant growth habit, flower color, pod color, and seed coat color (See Table 1). However, the plants differ in at least: parental genetics, Phytophthora resistance gene, and breeding history.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MEADOWS whose telephone number is (703)756-1430. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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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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CHRISTINA MEADOWS
Examiner
Art Unit 1663
/CHRISTINA L MEADOWS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663