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 .
Claims
In a preliminary amendment filed on April 3, 2025, Applicant canceled claims 1-20. Claims 21-39 are pending and are examined in this Office Action.
Duty of Disclosure
Applicant is reminded of their “Duty of Disclosure, Candor, and Good Faith” (see 37 C.F.R. § 1.56 and MPEP § 2001). Information that would be considered material to patentability includes: 1) any progeny, siblings, half-siblings, or other closely genetically related plants that are either co-pending applications or previously published or publicly disclosed, 2) if backcrossing was used in the breeding history, then the recurrent parent should be disclosed along with any publications or public disclosures of the recurrent parent, and what events/loci/transgenes/traits were donated from the non-recurrent parent along with any publications or public disclosures of the events/loci/transgenes/traits or of the donor parent line itself, 3) if the parental varieties were developed via backcrossing this should be disclosed along with the grandparents, including which grandparent was the recurrent parent along with any publications or public disclosures of the recurrent parent and what events/loci/transgenes/traits were donated from the non-recurrent parent, 4) any alternative designations, experimental names, tradenames, etc. for the instant plant, parent plants, and grandparent plants (if backcrossing was used for the parents) should be disclosed. All of this information is material to patentability. If, for example, one of the parent plants is published but with a different name/designation, then the publication should be included in the IDS along with an explanation that the different name/designation is a synonym and how this plant is related to the instantly claimed plant.
APPLICANT IS ADVISED TO INFORM THE EXAMINER IF ANY OF THE SOYBEAN VARIETIES THAT WERE DELETED FROM CLAIM 1 of PARENT APPLICATION 17/665,630 (CL1943627 or CK1943668) ARE CLOSELY RELATED GENETICALLY TO THE VARIETY UNDER EXAMINATION (i.e. BACKCROSSING IN THEIR BREEDING HISTORY UTILIZING THE SAME RECURRENT PARENT, OR SIBLINGS FROM THE SAME BREEDING PROGRAM, ETC.). If they are closely related, they should be examined together along with the instantly claimed soybean.
Specification
The disclosure is objected to because of the following informalities: there are blank lines where there should be an accession number, date of deposit, and date of viability testing (Spec 39).
The title is objected to because it is not descriptive of the claimed invention. The following title is suggested: - - SOYBEAN VARIETY CL1942258 - - .
Appropriate correction is requested.
Claim Interpretation
Claim 23 is interpreted to encompass a plant that was directly transformed rather than a plant which had a transgene introgressed via crossing and/or backcrossing.
Claim 26 recites “… sufficient inbreeding to produce an inbred soybean plant…” and one of ordinary skill in the art would understand this means ending with multiple rounds of selfing and/or sibling crossing to fix the genetics.
Claim 33 recites “single locus conversion” and claim 34 recites “single locus”. This is interpreted to mean that there is only one locus converted relative to the deposited seeds of the line.
Claim Objections
Claims 1, 6, and 12 are objected to because of the following informalities:
Claim 21 recites the acronym “NCMA” without first defining it. Any acronyms should have the full name written out with the acronym in parentheses the first time it appears.
Claim 31 includes “a site-specific recombination site” in a Markush grouping of traits, and this is not a trait. Applicant is advised to insert - - the transgene or locus comprises a site-specific recombination site or wherein - - between “claim 30, wherein” and “the desired trait”; and delete “a site-specific recombination site” from the list of traits.
Appropriate correction is requested.
Claim Rejections - 35 USC § 112
Indefiniteness
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 21-39 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are directed to plants and seed of soybean CL942258 and methods of using them. The title of the Application is “Soybean Variety” and the second and third sentences of the specification are in the section “The Field of the Invention” and state the following:
The present invention is in the field of soybean cultivar breeding and development. The present invention particularly relates to the soybean cultivar CL1942258, CL1943627, and/or CL1943668 and its seed, cells, germplasm, plant parts, and progeny, and its use in a breeding program. (Spec 1, emphasis added).
The instant claims recite “soybean CL942258”, and the Examiner interprets this to mean “soybean cultivar CL942258” or “soybean variety CL942258”.
Applicant defines the words “variety” and “cultivar” as follows:
“Variety” or “Cultivar” refer to 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 or cultivar include seeds, plants, plant parts, and/or seed parts of the instant soybean line. (Spec 19).
It is unclear what is meant by “substantially homozygous soybean line”. It is unclear what is meant by “minor modifications”. It is unclear what is meant by “retains the overall genetics”. It is unclear what a “subline” is. A locus conversion, a mutation, a transgenic, and a somaclonal variant are all derivatives produced by modifying a starting material, and it is unclear what starting material is being referred to in this context. As written this seems to state 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. What plant material is considered to be the unmodified plant material that has NO “minor modifications” and no converted loci and no mutations and no transgenes and no variations? Without known what the starting material is, it is unclear how to determine if any given genomic sequence is one of the modifications or if it was the beginning material prior to any modifications.
See Nautilus, Inc. v. Biosig Instruments, Inc, No. 13-369, in which the Supreme Court held that a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.
With regard to the term “substantially homozygous”, specifically:
An online dictionary (dictionary.com) defines “substantially” as follows:
adverb
by an ample or considerable amount; quite a lot:As a professor, my workload is substantially reduced or eliminated during the summer months.
in a basic or essential way; fundamentally:The new law mandates equal pay for substantially similar work, whether at the same establishment or not.
in a solid or firm way; stoutly or sturdily:In the far north, homes take more fuel to heat and also have to be built more substantially.
in a corporeal or material way; physically:The Eucharist makes the very Person of Christ truly, really, and substantially present in the consecrated bread and wine.
Within the US Patent literature for biotechnology, there are numerous examples of different interpretations of the word “substantially”, some are provided here:
US 2022/0025394; paragraph 0076, which states “The terms "substantial identity" in the context of a peptide indicates that a peptide comprises a sequence with between 55-100% sequence identity to a reference sequence preferably at least 55% sequence identity, preferably 60% preferably 70%, more preferably 80%, most preferably at least 90% or 95% sequence identity to the reference sequence over a specified comparison window. Preferably, optimal alignment is conducted using the homology alignment algorithm of Needleman and Wunsch, supra. An indication that two peptide sequences are substantially identical is that one peptide is immunologically reactive with antibodies raised against the second peptide. Thus, a peptide is substantially identical to a second peptide, for example, where the two peptides differ only by a conservative substitution. In addition, a peptide can be substantially identical to a second peptide when they differ by a non-conservative change if the epitope that the antibody recognizes is substantially identical. Peptides which are "substantially similar" share sequences as noted above, except that residue positions which are not identical may differ by conservative amino acid changes.
US 2022/0073890: paragraph 0430, which states “Polynucleotide and polypeptide sequences, variants thereof, and the structural relationships of these sequences can be described by the terms "homology", "homologous", "substantially identical", "substantially similar" and "corresponding substantially" which are used interchangeably herein. These refer to polypeptide or nucleic acid sequences wherein changes in one or more amino acids or nucleotide bases do not affect the function of the molecule, such as the ability to mediate gene expression or to produce a certain phenotype.”
US 2022/0072154: paragraph 0042, which states “The terms "substantially identical" or "substantial identity," in the context of two or more nucleic acids, refer to two or more sequences or subsequences that are the same or have a specified percentage of nucleotides that are the same (i.e., at least about 60%, typically at least about 65%, 70%, 75%, 80%, 85%, 90%, or 95% identity over a specified region), when compared and aligned for maximum correspondence over a comparison window, or designated region as measured using one of the following sequence comparison algorithms or by manual alignment and visual inspection.”
US 2022/0068965: paragraph 0093, which states “… the term "substantially identical" meaning identical to within reasonable tolerances of fabrication and measurement.”
US 2022/0047621: paragraph 0027, which states “A sequence is "substantially complementary" to a target sequence if the sequence is at least about 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% complementary to a target sequence. Percent complementarity can be calculated by dividing the number of bases in a first sequence that are complementary to bases at corresponding positions in a second or target sequence by the total length of the first sequence. A sequence may also be said to be substantially complementary to another sequence if there are no more than 5, 4, 3, or 2 mismatches over a 30 base pair duplex region when the two sequences are hybridized.”
US 2022/0033614: Paragraph 0027, which states “The term "substantially" is defined as largely but not necessarily wholly what is specified (and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel), as understood by a person of ordinary skill in the art. In any disclosed implementation, the term "substantially" may be substituted with "within [a percentage] of" what is specified, where the percentage includes 0.1, 1, or 5 percent; and the term "approximately" may be substituted with "within 10 percent of" what is specified.
This limited sampling of US Patent publications demonstrates widely varying definitions for "substantially".
A review of the prosecution history and specification did not shed any light on the meaning of the ambiguous language of “substantially”. For these reasons, the claims are indefinite because one of skill in the art, in light of the specification and prosecution history, would not know with reasonable certainty what the scope of the claimed invention is. Is there a particular percentage of loci or single nucleotide polymorphisms required to be identical to qualify as “substantially homozygous”? Are loci controlling specific phenotypic traits required to be homozygous? If so, which traits?
The definition of “minor” according to the online merriam-webster dictionary is: “inferior in importance, size, or degree : comparatively unimportant” (downloaded from w w w.merriam-webster.com/dictionary/minor on May 29, 2024). It is unclear what “minor modifications” means as far as the scope of the definition for “variety” because it is unclear which of the disclosed traits would be considered of lesser importance. It is unclear what modifications can be made and still be considered within the scope of the “variety”.
The definition of “overall” according to the online britannica dictionary is: “viewed as a whole or in general” (downloaded from w w w.britannica.com/dictionary/overall on May 29, 2024). It is unclear what is meant by “overall genetics” means as far as the scope of the definition of “variety”. How much of the genome can be altered and still be considered to have retained the “overall” genetics?
The scope of a locus conversion as discussed in the specification as follows in the excerpt pasted below:
“Locus converted (conversion), also single locus converted (conversion): refers to seeds, plants, and/or parts thereof developed by backcrossing and/or genetic transformation to introduce a given locus that is transgenic in origin, wherein essentially all of the morphological and physiological characteristics of a variety are recovered in addition to the characteristics of the locus or possibly loci which has been transferred into the variety. The locus can be a native locus, a transgenic locus, or a combination thereof. (Spec 18).
This allows for an unlimited number of changed loci. The metes and bounds of what a “locus conversion” of CL942258 would be is completely unclear, especially since the loci are converted relative to CL942258, itself. Furthermore, it is unclear what is meant by “essentially all” of the morphological and physiological characteristics. The word “essentially” is defined by merriam-webster online dictionary as: “in essence : fundamentally” (downloaded from w w w.merriam-webster.com/dictionary/essentially on May 29, 2024). It is unclear which characteristics are the “essence” of the variety, or which characteristics are fundamental to the variety. This makes the metes and bounds of the variety completely unclear.
Further discussion about what plants are included in the genus of locus conversions and transgenics, and are therefore included in the recited “variety” is found in this paragraph:
In addition, plants and plant parts substantially benefiting from the use of variety CL1942258 ... ... in their development, such as variety CL1942258 ... ... comprising a backcross conversion, locus conversion, transgene, or genetic sterility factor, may be identified by having a molecular marker profile with a high percent identity to soybean variety CL1942258 ... . Such a percent identity might be 90%, 91 %, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, 99.5% or 99.9% identical to soybean variety CL1942258 ... . (Spec 22-23).
NOTE: three varieties are included in this excerpt, so the Examiner removed the other two variety names.
This excerpt is merely exemplary rather than being a definition, but it is clear that the intention is for a locus conversion to allow for at least 10% variation of a molecular profile, but unclear how many molecular markers or which marker set this is referring to.
With regard to mutations, specifically, Pavadai et al (Journal of Phytology (2009) Vol. 1; pp. 444-447) teach that there are multiple different treatments that can be used to induce mutations in a soybean’s genome, resulting in many different phenotypes, some of which were lethal (Pavadai 445). 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 CL942258”. Are there any traits or genes that are essential to “variety CL942258” that must remain unaltered relative to the deposited seeds?
With regard to somaclonal variants, specifically, Barwale et al (Plant Cell Reports (1987) Vol. 6; pp. 365-368) teach that multiple different phenotypic variations were observed in somaclonal variants of soybeans, including albino, abnormal leaves, different leaflet number, and dwarfs (Barwale 366). It is unclear how many somaclonal variations can be introduced and which characteristics can be changed and continue to be covered by the instant label of “variety CL942258”. Are there any traits or genes that are essential to “variety CL942258” that must remain unaltered relative to the deposited seeds?
Therefore, given the definition of “variety” or “cultivar” in the specification, and the examples found in the specification as set forth, above, plants of “soybean CL1942258” 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. The plants encompassed by the variety name may be identified by a “molecular marker profile with a high percent identity to CL942258”. The percent identity might be 90%.
All of this background in the specification renders the metes and bounds of “soybean CL942258” unclear. It is clear that “variety” and “cultivar” are defined as including sublines, locus conversions, mutants, transgenic versions of a starting plant, and somaclonal variants of a starting plant, and plants having minor modifications and retaining the overall genetics, but the further discussions in the specification have percent identity or characteristic comparisons relative to the variety itself. This arrives at a place where a plant of variety CL942258 can have 90% molecular marker identity relative to itself, or has multiple loci converted relative to itself or mutations relative to 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 on pages 42-43 of the specification. 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?
Claim 21 recites “representative sample of seed” of said soybean having “been deposited under NCMA Accession Number 202402003”, and it is unclear how the seed is “representative”. It is clear that the “variety” or “cultivar” 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. Furthermore, Applicant has not, yet, perfected the deposit of these seeds that are intended to be “representative”, therefore, they cannot be relied upon until such a time they are made available pursuant to 37 CFR 1.801-1.809.
Lack of Enablement
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 21-39 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are directed to a plant, plant part, or seed of soybean line CL1942258, wherein a representative sample of seed of said line has been deposited under NCMA Accession Number 202402003; and to cells of said plant and methods that utilize said plant or plant part or seed and to products derived from said plant or plant part or seed.
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, the requirements of 35 USC § 112 may be satisfied by a deposit of the seeds. A deposit of 625 seeds of the line/variety/cultivar is considered sufficient for most plant species to ensure public availability. The specification does not disclose a repeatable process to obtain the plant. It is noted the specification states that Applicant intends to deposit seeds with the American Type Culture Collection (ATCC) (Spec 39) but the deposit has not, yet, been made, and therefore no accession number is available. The claims recite an NCMA accession number, but the specification does not provide any information about the NCMA. Furthermore, they have not stated if the deposit will be made or was made under the Budapest Treaty or not.
(a) If a deposit is made under the terms of the Budapest Treaty, then the specification must include the street address of the depository and Applicant must provide a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over their signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
(b) If a deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, 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:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) 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);
(iii) 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, and the specification will include the street address of the depository;
(iv) a test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable.
Inadequate Written Description
Claims 21-39 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The instant claims are broadly drawn to plants and seeds of soybean CL942258, and plants and seed derived from soybean CL942258, and methods of using said plants/seeds. As discussed, above, in the indefiniteness rejection, the specification and title refer to the invention as a “variety” or “cultivar” and provides such a broad definition of “variety”/”cultivar” that the metes and bounds of what soybeans would be covered by “soybean CL942258” are completely unclear. It is clear that “soybean CL942258” 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. See, for example, Tsuda et al. (BMC Genomics (2015) Vol. 16; pp. 1-18) who teach that the average number of base changes per line of soybeans treated with EMS was 12,796 changes (Tsuda 1). Songstad et al (Critical reviews in plant sciences (2017) Vol. 36; pp. 1-23) estimated that EMS mutagenized Arabidopsis plants could contain 700 induced mutations in an individual plant (Songstad 6).
See, for example, Pavadai et al. (J. of Phytology (2009) Vol. 1; pp. 444-447) who teach that mutations in soybean resulted in phenotypes that were recorded as 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 445), and also resulted in changes in protein and oil content (Id. 446). In addition, Khan et al. (J. of Cereals and Oilseeds (2013) Vol. 4; pp. 19-25) teach that soybean mutants had changes 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 20-3). 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) (Spec 59-60). “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.
In addition, the instant specification does not provide a breeding history for soybean CL1942258.
35 USC 112 (a) states that “The specification shall contain a written description of the invention”. In evaluating written description, the threshold question is what is “an adequate written description”. This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
The instant invention is a new soybean variety (CL1942258). So, the examiner will evaluate what is an adequate written description for a new soybean variety (also referred to in the art as “line” or “cultivar”). In reviewing this question of fact, the examiner analyzed how plant varieties are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety has a trait table and genetic information (via a breeding history). In reviewing applicant’s specification there is a phenotypic description as is seen in table 1 (Spec 42-43). However, there is no accompanying breeding history in the specification. Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant variety the applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification. The office’s reasonable basis for challenging the adequacy of written description is informed by a review of the following:
With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Variety Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the variety new” (See “Applying for a Plant Variety Certificate of Protection”, USDA, https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023, (U)).
The International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology part of its evaluation of essentially derived plant varieties (UPOV, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30 (V)).
Historically, the USPTO has considered breeding history information when determining the patentability of a new plant variety. (See Ex Parte C (USPQ 2d 1492 (1992) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (X)). In both of these cases, there were many differences cited by the Applicant when comparing the prior art and the new plant variety. However, because the breeding history was available, these differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. Haun et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (Y)) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (p. 645, left column). Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (Z), p. 5430, left column, 1st full paragraph, and right column, 2nd full paragraph). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed to adequately describe a newly developed plant.
The above factual evidence provides a reasonable basis that a breeding history is a necessary part of written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary to the adequate description of a plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
MPEP 2163 (I) states “The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").”
MPEP 2163(I) states “The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
The breeding history aids in the resolution of patent infringement by providing information necessary to determine whether differences in the plants are genetic differences, differences caused by the environment, or differences within the accepted variation within a variety. Moreover, a specification devoid of a complete breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the complete breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement. Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, Applicant must amend the specification/drawings to provide the breeding history used to develop the instant cultivar. When identifying the breeding history, Applicant should identify any and all other potential names for all parental lines utilized in the development of the instant cultivar and all other potential names for the claimed cultivar. If Applicant’s breeding history uses proprietary cultivar names, Applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar information. If the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If one of the parents is a backcross progeny or locus converted line of a publicly disclosed line, Applicant should provide the breeding history of the parent line as well (i.e., grandparents). Applicant should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant cultivar). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
With regard to claims 32 and 36, specifically. These claims have an additional written description issue because there is no limit as to how many traits/transgenes/locus conversions that can be introduced into the plant. For this reason, the genus of plants and seeds encompassed by these claims is infinite. Every trait from Table 1 could be changed by introducing a transgene or locus conversion that alters each one of the traits. There are no particular traits that are required to be retained, nor is there any core structure that is required to be retained. For this reason, the large genus of plants and seeds encompassed by these claims is not adequately described.
Claim Rejections - 35 USC §§ 102/103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21-39 is/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 Threlkeld et al (US Patent No. 10,076,097 B1; issued on Sep. 18, 2018) in view of Gellin et al (US Patent No. 9,474,232 B2; issued on Oct. 25, 2016) and further in view of Mason, J. T. (US Pre-Grant Publication US 2020/0045903 A1; published on Feb. 13, 2020).
The claims are drawn to a plant or a seed, plant parts, of soybean CL1942258 or plants and plant parts derived from said variety, and methods that utilize said variety. It is unclear what the metes and bounds of “soybean CL1942258” are, as discussed, above, in the indefiniteness rejection; however, it is clear the variety encompasses modifications and variations compared to itself.
Threlkeld teaches plants of soybean cultivar CL1463417. Comparing the trait tables for the instant variety and CL1463417, the two share almost all of the traits (Spec 44, Threlkeld col. 26). The only differences are the addition of the Rag1_S aphid gene and the A5547-127 herbicide tolerance transgene that are present in the instant variety but not in the variety taught by Threlkeld.
However, the Rag1_S aphid gene and the A5547-127 herbicide tolerance transgene are both well known in the art. For example, Gellin teaches soybean variety BK1211980 which carries the Rag1_S aphid resistance gene (Gellin col. 23) and Mason teaches soybean cultivar S170111 which carries the A5547-127 herbicide tolerance gene (Mason 4 ¶ 71). The instant claims are broad enough to encompass the introduction of both of these genes via locus conversion, and the instant claims do not require any particular genomic DNA or characteristic/trait from the deposited seeds to be retained. Therefore, a plant of CL1463417 having these two genes introduced via locus conversion is an obvious variation that falls within the scope of the instant claims. All of the limitations of the dependent claims are the same limitations found in the claims of Threlkeld, Gellin, and Mason, therefore they are each obvious over this combination of references.
The Examiner cannot determine any differences between a plant made obvious be the combination of references and the instantly claimed soybean, however, if Applicant can provide a difference that is determined at a statistically significant level, the Examiner would need to perform the complete Deere analysis to determine if the difference is non-obvious. The analysis can not be completed without knowing what the difference(s) is/are.
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 21-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,076,097 B1 in view of Gellin et al (US Patent No. 9,474,232 B2; issued on Oct. 25, 2016) and further in view of Mason, J. T. (US Pre-Grant Publication US 2020/0045903 A1; published on Feb. 13, 2020).
The claim limitation mapping and analysis for these references as they apply to the instant claims is set forth, above, in the rejection under 35 USC 103.
Summary
No claim is allowed.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached M-F 9:00 - 5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A 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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CATHY KINGDON
Primary Examiner
Art Unit 1663
/CATHY KINGDON/Primary Examiner, Art Unit 1663
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