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 .
Claim Status
Claims 1-27 are pending and examined.
State of the Art
The Examiner sets forth the following findings of fact (FF) in order to understand the instant invention:
FF1: Alfalfa is naturally crosspollinated by bees and “tolerates comparatively little inbreeding” (Rumbaugh, 1988, “Breeding and Quantitative Genetics” Chapter 25 in Alfalfa and Alfalfa Improvement, Eds. Hanson et al; American Society of Agronomy, Inc. Crop Science Society of America, Inc. Soil Science Society of America Inc.; p. 777-808; see p. 777).
FF2: Alfalfa has 8 chromosomes and all cultivars are autotetraploids, meaning four copies of each of the eight chromosomes that will readily recombine with one another via cross-over events during sexual propagation, resulting in complex inheritance for economic traits (Rumbaugh, p. 777).
FF3: For decades, breeders have stressed the development of cultivars with multiple pest resistance incorporated into genetically broad-based synthetics from which commercial seed is produced under limited generation schemes (Rumbaugh, p. 778).
FF4: Alfalfa in the USA was derived from nine different germplasm sources: M. falcata, Ladak, M. varia, Turkistan, Flemish, Chilean, Peruvian, Indian, and African (Rumbaugh, p. 779).
FF5: There are multiple different definitions for “synthetic variety” known in the art, and the definition that most closely resembles the breeding history described in the instant specification is attributed to Wood as follows: “Wood defined a synthetic cultivar as an advanced generation of an open-pollinated population composed of a group of selected inbreds, clones, or hybrids.” (Rumbaugh, p. 780).
FF6: Synthetic cultivars formed from 100 or more clones are expected to be more stable during seed multiplication than narrow based synthetics (Rumbaugh, p. 781).
FF7: Most genes for resistance are dominant (Rumbaugh, p. 782).
FF8: When crossing plants with two favorable dominant genes at different loci, less than half will inherit both of the dominant genes and 10% will not have either dominant gene (Rumbaugh, p. 782).
FF9: The National Alfalfa and Forage Alliance (NAFA) published ratings for alfalfa varieties that demonstrate a variety that is designated with “high resistance” is only required to have resistance in greater than 50% of the plants, “resistance” means 31-50% of the plants in the population are resistant, and “moderate resistance” means 15-30% of the plants are resistant (Alfalfa Variety Ratings 2020, 2020,The National Alfalfa and Forage Alliance; p. 1-8).
FF10: Self-pollination can cause issues because of plants that have self-incompatibility which reduces the seed set and can cause inbreeding depression, and inbreeding has a catastrophic effect on alfalfa (Rumbaugh, p. 786 and 803).
FF11: The phenotypic effects of traits in which having different alleles at the same locus (heterozygosity) causes interactions that affect the phenotype is very complicated and hard to predict (Rumbaugh, p. 795-8).
FF12: Populations of alfalfa are rarely, if ever, in random mating equilibrium (RME) (Rumbaugh, p. 803).
FF13: Selfing a population for only two or three generations leads to near extinction of the population due to loss of vigor and increased sterility and is associated with changes in the performance of synthetic varieties over generations (Rumbaugh, p. 804-5).
FF14: Alfalfa seed production fields produce a higher level of heterozygosity than what would be predicted based on the Hardy-Weinberg equilibrium with an excess of heterozygotes in both the parents and the progeny (Mabin et al, 2021, Frontiers in Plant Science; Vol. 12; p.. 1- 15; page 11).
In summary, these findings of fact demonstrate that a “synthetic variety” is defined and characterized by the distribution and frequency of characteristics and genes throughout the entire population rather than being defined and/or characterized by any attributes of an individual plant or seed.
Claim Objections
Claims 1 and 9 are objected to because each of these claims recites “NCMA Accession No. 202210027” but this accession does not conform to 37 CFR 1.801.
As set forth in 37 CFR 1.801, “For the purposes of these regulations pertaining to the deposit of biological material for purposes of patents for inventions under 35 U.S.C. 101, the term biological material shall include material that is capable of self-replication either directly or indirectly” (emphasis added).
Here, the instantly claimed variety is not capable of self-replication because alfalfa is a heterozygous autotetraploid such that any progeny will not be the same as the parent plant grown from the deposited seed.
Regarding claim 11, Applicant is advised that should claim 5 be found allowable claim 11 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Here, each claim is directed to an alfalfa plant that is produced by a method, and there is nothing in either of the methods that would confer a specific distinguishing characteristic onto the plant that is produced rendering the claimed plants identical in scope.
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 1-27 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.
Claim 1 is drawn to a seed of alfalfa variety R0419A3140, wherein representative seed of said alfalfa variety have been deposited under NCMA Accession No. 202210027.
The metes and bounds of the claim are indefinite because it is unclear how any given seed is “representative” of this variety as it is a synthetic variety encompassing a diverse and very heterogeneous population of alfalfa plants resulting from crosses of 220 separate parent plants (¶ 16).
This conclusion is further supported in light of the fact that 49% of the plants that are members of the variety do not need to have the resistances that are designated “high resistance” and 69% of the plants that are members of the variety do not need to have the resistances that are designated “resistance” (e.g., see FF9).
Each of the deposited seeds will only have a subset of the resistance traits that are disclosed for the variety. With regard to the genetics, the genetics are quite diverse with 180 separate parent plants such that it is unclear how any given deposited seed would be “representative” of the variety as a whole by either phenotype or by genotype.
Claims 5, 10, 11, 15, and 20 each require “all of the physiological and morphological characteristics of a plant of said alfalfa variety R0419A3140” while claims 17 and 21 each require “all of the physiological and morphological characteristics of a seed of said alfalfa variety R0419A3140”.
The metes and bounds of the claim are indefinite because it is unclear what characteristics of the variety any particular plant within the variety will retain.
For example, Tables 1-15 indicate that any given R0419A3140 plant may have the presence and absence of a higher total or mean yield compared with the check varieties, the presence and absence of the fall dormancy rating in Table 5, the presence and absence of salt tolerance, resistance or susceptibility to anthracnose disease (Race 1), resistance or susceptibility to Aphanomyces root rot (Race 2), resistance or susceptibility to bacterial wilt, resistance or susceptibility to fusarium wilt, resistance or susceptibility to verticillium wilt, resistance or susceptibility to Phytophthora root rot, resistance or susceptibility to Aphanomyces root rot (Race 1), resistance or susceptibility to stem nematode, resistance or susceptibility to spotted alfalfa aphid, and resistance or susceptibility to pea aphid.
However, no given plant can simultaneously have and not have these traits so that it is not clear what traits a plant with “all of the physiological and morphological characteristics of a plant of said alfalfa variety R0419A3140” will possess.
Claims 2-4, 6-9, 12-14, 16-19 and 21-27 are rejected for depending upon a rejected base claim and for failing to remedy the issues of indefiniteness.
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 1-27 are rejected under 35 U.S.C. 112(a) as containing 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.
Since the seed claimed is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112.
The specification teaches that alfalfa variety R0419A3140 is a synthetic variety with 180 parent plants (¶ 016). However, the specification does not disclose a reproducible process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
If the deposit of the seed is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating the seed have been deposited under the Budapest Treaty and that the seed 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 criteria set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(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 unviable.
Applicant has NOT deposited the seeds at the NCMA in accordance with 37 CFR 1.801-1.809 by indicating all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
Applicant has also not indicated an intention to deposit the seeds in accordance with the Budapest Treaty, and by way of affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stated that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent.
Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809, the NCMA Accession No. and evidence of deposit to overcome this rejection. Alternatively, Applicant may by way of affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, state that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent.
Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Claims 1-27 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 claims contain subject matter that 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.
While Applicant has made a deposit of R0419A3140, a deposit cannot provide an individual plant with all of the disclosed resistances or a population of plants with the same statistical distribution of alleles.
As discussed above, there is a high degree of indefiniteness regarding what is required for a particular seed or plant to be a member of alfalfa variety R0419A3140; however, one interpretation is that a plant of this variety must have all of the characteristics disclosed in ¶ 20:
[020] Alfalfa variety R0419A3140 is highly resistant to anthracnose (Race 1), bacterial wilt, Fusarium wilt, Verticillium wilt, Phytophthora root rot, Aphanomyces root rot (Race 1), Aphanomyces root rot (Race 2), and stem nematode; with resistance to pea aphid and spotted alfalfa aphid.
Applicant has deposited seeds of variety R0419A314 but within a population of plants grown from these seeds the vast majority of the plants will not have all of the resistances disclosed for variety R0419A3140 (e.g., FF8), and it is possible for a plant to not have any of those resistances.
Therefore, one of skill in the art would need to grow multitudes of seeds and screen for any individual plant that possesses all these resistances, if there is even one such plant to be found which is tantamount to excessive and impermissible undue trial and error experimentation.
Furthermore, if one of skill in the art were to request seeds from NCMA Accession No. 202210027, they would receive a package of 25 seeds. There is no possibility that these 25 seeds would grow into a population having the same statistical distribution of alleles as the population that was designated “variety R0419A3140”.
Because the deposited seeds are not inbred, but rather a heterogeneous mixture of autotetraploid seeds that have a high degree of heterozygosity, growing any given seed of the deposit and allowing it to self-pollinate will not result in progeny that are the same as the parent plant.
Therefore, the deposited seeds are not enabling for the instant invention by either providing an individual plant with all of the disclosed resistances or by providing a population of plants with the same statistical distribution of alleles.
Claims 10 and 11 are drawn to a seed and a plant of a first-generation progeny alfalfa produced by selfing a plant of variety R0419A3140, wherein the first-generation progeny seed and plant have all of the physiological and morphological characteristics of a seed and plant of alfalfa variety R0419A3140.
Claim 17 is drawn to a seed that produces an alfalfa plant made by introducing a transgene or a single locus conversion into a plant of alfalfa variety R0419A3140, wherein the plant comprising the transgene or single locus conversion otherwise comprises all of the physiological and morphological characteristics of variety R0419A3140.
Claim 20 is directed to an alfalfa plant produced by crossing a plant of variety R0419A3140 with a second alfalfa plant comprising a single locus to produce a first generation progeny plant, and selecting a progeny plant that comprises the single locus, wherein the selected progeny plant otherwise comprises all of the physiological and morphological characteristics of variety R0419A3140.
Claim 21 is directed to a seed that produces said plant wherein the seed otherwise comprises all of the physiological and morphological characteristics of a seed of variety R0419A3140.
As discussed supra, the limitation “all of the physiological and morphological characteristics of variety R0419A3140” is unclear: if this limitation means the claimed plants must have all of the resistances and susceptibilities listed in ¶ 20 then claims are not enabled for the reasons previously stated.
Every one of these claims requires sexual reproduction that results in the production of a seed. As noted in the written description rejection, the variety R0419A3140 is a “synthetic” variety produced by a polycross among 180 different parental plants.
As a result the four copies of each chromosome within any given plant of variety R0419A3140 are variable relative to one another and will not yield predictable results as there is no guarantee that any given seed produced by selfing a plant of variety R0419A3140 would grow into a plant having any or all of the characteristics of variety R0419A3140.
Therefore, given the unpredictability in the art and the lack of even one single working example, one of skill in the art would be unable to make and use the claimed invention.
With respect to each of claims 5, 10, 11, 15, and 20 each require “all of the physiological and morphological characteristics of a plant of said alfalfa variety R0419A3140” while claims 17 and 21 each require “all of the physiological and morphological characteristics of a seed of said alfalfa variety R0419A3140”.
Tables 1-15 indicate that any given R0419A3140 plant may have, for example, the presence and absence of a higher total or mean yield compared with the check varieties, the presence and absence of the fall dormancy rating in Table 4, the presence and absence of salt tolerance, resistance or susceptibility to anthracnose disease (Race 1), resistance or susceptibility to Aphanomyces root rot (Race 2), resistance or susceptibility to bacterial wilt, resistance or susceptibility to fusarium wilt, resistance or susceptibility to verticillium wilt, resistance or susceptibility to Phytophthora root rot, resistance or susceptibility to Aphanomyces root rot (Race 1), resistance or susceptibility to stem nematode, resistance or susceptibility to spotted alfalfa aphid, and resistance or susceptibility to pea aphid. R0419A3140 plants can both have or not have these and any the other traits of the R0419A3140 variety. These plants are not enabled because no given plant can simultaneously have and not have these traits.
Claims 5, 14, 15, 22, and 23 are also rejected because they are drawn to a progeny plant or seed of alfalfa variety R0419A3140 further comprising a transgene or a locus conversion that has been introduced by backcrossing or genetic transformation into variety R0419A3140.
The specification teaches that alfalfa variety R0419A3140 is a synthetic variety from intercrossing of 220 different parental lines meaning it is a complex synthetic variety rather than a true-breeding inbred or an F1 hybrid (¶ 16). However, it is not possible to perform the backcross method using a heterozygous plant as the recurrent parent plant because the genetics of the heterozygous plant are not stable and uniform (e.g., see Plant and Soil Sciences eLibrary 2023; downloaded on Aug. 26, 2023).
Moreover, it is not possible to arrive at a progeny plant having all of the physiological and morphological characteristics of variety R0419A3140 by crossing variety R0419A3140 with itself or another plant.
The state-of-the-art teaches the goal of backcrossing is to recover the genome of the recurrent parent. Chukwu et al teaches that the percentage of the parent genome recovery (RP.R) using markers to assist with selection after backcrossing was about 95%, and this is only possible if the recurrent parent plant has stable and uniform genetics (2020, Plants 9:1-15).
For alfalfa, Wang showed that in the cultivars they studied 60.4% of the genetic variation was within the populations of cultivars (synthetic varieties) and only 39.6% of the genetic differences were between cultivars (Wang et al, 2011, Acta Agriculturae Scandinavica Section B – Soil and Plant Science, 61:60-66; see p. 60; see also Abstract). One cannot recover the genetics of a recurrent parent if there is so much genetic variation within the population encompassed by the variety itself.
Given the lack of guidance in the instant specification, undue trial and error experimentation would be required for one of skill in the art to use the backcross method with a hybrid recurrent parent plant and be able to recover the genetics and characteristics of the hybrid parent plant.
Therefore, given the breadth of the claims; the lack of guidance and working examples; the unpredictability in the art; and the state of the art as presented above, undue experimentation would be required to make the claimed invention, and therefore, the invention is not enabled throughout the broad scope of the claims.
Claims 1-27 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 claims contain subject matter that 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 claims are directed to seeds and plants of alfalfa variety R0419A3140, seeds or plants produced by methods that encompass sexual propagation with alfalfa variety R0419A3140, methods of introducing locus conversions into said variety, and a method of producing a synthetic alfalfa variety.
Alfalfa variety R0419A3140 is a synthetic variety encompassing an extremely large genus of plants produced by a random mating open pollination of 180 parental plants (¶ 16). The specification indicates this variety has been described by characteristics of a large enough group of plants to produce statistics on the distribution of different characteristics (Tables 1-15). Therefore, this is considered a description of a population or plants rather than a description of any individual plant or seed.
The specification describes plants of alfalfa variety R0419A3140 as possessing and not the presence and absence of a higher total yield compared with the check varieties, the presence and absence of the fall dormancy rating in Table 4, resistance or susceptibility to anthracnose disease (Race 1), resistance or susceptibility to Aphanomyces root rot (Race 2), resistance or susceptibility to bacterial wilt, resistance or susceptibility to fusarium wilt, resistance or susceptibility to verticillium wilt, resistance or susceptibility to Phytophthora root rot, resistance or susceptibility to Aphanomyces root rot (Race 1), and resistance or susceptibility to pea aphid (see Tables 1-15).
However, the specification fails to describe a plant both comprising and not these traits or the other traits of R0419A3140. Moreover, the specification fails to describe the traits or genes that must be present in an alfalfa plant for it to be deemed a plant of alfalfa variety R0419A3140.
The structural features that distinguish a plant of alfalfa variety R0419A3140 from other alfalfa plants are also not described in the specification. Given the traits of R0419A3140 are unclear and thus may or may not have genes conferring said traits, the skilled artisan would be unable to distinguish between alfalfa plants of the art and those of alfalfa variety R0419A3140.
Claims 10 and 11 are drawn to progeny of the synthetic variety having the same issue but exacerbated by further genetic recombination. A plant or seed generated from sexual reproduction is not described, because the genome will no longer be the same as the genome of any of the deposited seeds and the resulting characteristics will also be different.
A progeny produced by sexual reproduction will have four copies of each chromosome: two from the female parent and two from the pollen donor plant. Each of these chromosomes will be a random combination of DNA from the four chromosomes of the respective parent plants due to crossing over.
Methods such as instant claim 14 involving backcrossing to introduce a locus conversion are also inadequately described, because they rely upon using a “recurrent parent” (e.g., see ¶ 29, 30 and 43-45). However, a successful backcross program relies upon a satisfactory recurrent parent that should be an inbred line (Plant and Soil Sciences eLibrary 2023; downloaded on 26 August 2023). If the recurrent parent is heterozygous, it goes through meiosis to produce pollen or an ovule, and the genome is not the same as the genome of the parent plant.
Commercial alfalfa cultivars are mostly synthetic populations formed from a large number of parents that such synthetic varieties have a broad genetic base (Wang et al, p. 60). In fact, Wang et al describe that of cultivars studied 60.4% of the genetic variation was within the populations of cultivars (synthetic varieties) and only 39.6% of the genetic differences were between cultivars (see Abstract).
Here, the instant variety is produced by a multi-cross of 180 parental plants and thus has a broad genetic base such that backcrossing to an individual recurrent parent, or even a few recurrent parents, cannot restore the progeny to the genetic and/or phenotypic characteristics of plants produced by a 180-way random polycross.
Therefore, Applicant has not, in fact, described plants of alfalfa variety R0419A3140, and the specification fails to provide an adequate written description of the claimed invention.
Applicant should further note the instant specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because it does not provide a description sufficient to conduct an to conduct an examination, including search of the prior art
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.").”
The instant Specification fails to satisfy the written description because it does not provide enough description to be sufficient to aid in the resolution of questions of infringement.
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).
In the instant matter Applicant has not provided the breeding history for the instantly claimed plant variety. This description is critical because a plant variety is defined by both its genetics (i.e., the breeding history) and its traits. In the instant specification, Applicant has only provided a description of the plant traits in Tables 1-15 but is silent regarding the breeding history used to produce the claimed plant variety.
The importance of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”. Other bodies that grant intellectual property protection for plant varieties require breeding information to evaluate whether protection should be granted to new varieties.
A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Variety Protection (PVP) applications which is used to “determine if development is sufficient to consider the variety new” (USDA, “Applying for a Plant Variety Certificate of Protection”, https://www.ams.usda.gov/services/pvpo/ap.lication-help/ap.ly, accessed 1 May 2023).
Additionally, 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, 2017, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, see notes 14 and 30). While the USPTO, USDA, and UPOV have different laws governing intellectual property rights, all recognize that a breeding history is an essential part of adequate description of the plant sought to be protected.
The breeding history is also necessary to aid in the resolution of patent infringement by providing information necessary to determine whether differences in plants where genetic differences, differences caused by the environment, or differences within the accepted variation within a variety.
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) and Ex Parte McGowen, Board Decision in Application 14/996,093, 2020). 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.
Moreover, a specification devoid of a 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 breeding history, the public will not be able to fully resolve questions of infringement, and can 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/drawing to provide the breeding history used to develop the instant variety or 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 variety. For alfalfa, this should also include the locations and years the parents were obtained from.
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.
The following is a quotation of 35 U.S.C. 103, which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-27 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 McCaslin et al (Patent No. US 10,687,505 B1).
Instant claims 1-27 are drawn broadly to alfalfa variety R0419A3140, seeds of said variety, tissue cultures of said variety and plants produced therefrom and methods of using said variety wherein said variety comprises locus conversions or transgenes, and commodity products produced from said variety (see claims 1-27).
McCaslin et al teaches alfalfa variety 412A121, seeds of said variety, tissue cultures of said variety and plants produced therefrom and methods of using said variety wherein said variety comprises locus conversions or transgenes, and commodity products produced from said variety (see claims 1-27).
McCaslin et al teaches alfalfa variety 412A121 has virtually all traits and resistances as instantly claimed variety R0419A3140 (see Tables 1-14). As noted supra, it is unclear what is required for an individual plant or seed to be a member of variety R0419A3140, and the same issue exists for the prior art because it is unclear what is required for an individual plant or seed to be a member of variety R0419A3140.
Thus, if even one deposited seed from the McCaslin et al grows into a plant that is indistinguishable from one member of the genus of plants encompassed by the instant claims then McCaslin et al anticipates the claims.
However, in the event there are statistically significant differences or differences in the genetics between the instantly claimed variety and that as taught by McCaslin et al, one would have found it prima facie obvious, and with a reasonable expectation of success, to arrive at the plants as claimed because one would continue breeding and multiplying using the alfalfa taught by McCaslin et al, and additional breeding and multiplying would result in at least one plant that is indistinguishable from at least one plant encompassed by the instant claims.
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 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 Patent No. US 10,687,505 B1 (referred to herein as ‘505). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1-27 are drawn broadly to alfalfa variety R0419A3140, seeds of said variety, tissue cultures of said variety and plants produced therefrom and methods of using said variety wherein said variety comprises locus conversions or transgenes, and commodity products produced from said variety (see claims 1-27).
‘505 teaches alfalfa variety 412A121, seeds of said variety, tissue cultures of said variety and plants produced therefrom and methods of using said variety wherein said variety comprises locus conversions or transgenes, and commodity products produced from said variety (see claims 1-27).
‘505 teaches alfalfa variety 412A121 has virtually all traits and resistances as instantly claimed variety R0419A3140 (see Tables 1-14). As noted supra, it is unclear what is required for an individual plant or seed to be a member of variety R0419A3140, and the same issue exists for the prior art because it is unclear what is required for an individual plant or seed to be a member of variety R0419A3140.
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive at the plants and seeds as claimed, and with a reasonable expectation of success because seeds of alfalfa variety R0419A3140, plants produced therefrom and methods of using said plants and seeds is anticipated by ‘505 as variety 412A121 is virtually indistinguishable species of seeds from the genus of alfalfa variety R0419A3140, plants produced therefrom and methods of using said plants and seeds.
Conclusion
No claim is allowed.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662