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
The originally filed claims 1-27 are pending and are examined in this Office Action.
Specification
The disclosure is objected to because it contains embedded hyperlinks and/or other forms of browser-executable code on page 20 in paragraph 35 and on page 21 in paragraph 38. Applicant is required to delete the embedded hyperlinks and/or other forms of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or www. or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1, 8, 9, 16, and 26 are objected to because of the following informalities:
Claims 1 and 9 are objected to because each of these claims recites “NCMA Accession No. 202210028” but this accession does not conform to 37 CFR 1.801. 37 CFR 1.801 states: “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). In this case, the deposited seeds are not capable of self-replication because they are heterozygous autotetraploids, and any progeny will not be the same as the parent plant grown from the deposited seed.
Claim 8 recites “… crossing the plant of claim 2 with itself or with a second alfalfa plant …” and this is technically incorrect because one does not cross a plant with itself (Spec 39, definition of “Crossing”), rather this is self-pollinating; Applicant is advised to replace “crossing the plant of claim 2 with itself or with a second alfalfa plant” with - - crossing the plant of claim 2 with a second alfalfa plant or self-pollinating the plant of claim 2 - - .
Claim 16 includes “improved forage or seed yield,”, and it is improper to include “or” in the list of choices for a Markush Group; Applicant is advised to replace this with - - improved forage yield, improved seed yield, - - .
Claim 26 uses the indefinite article “a” for the recitation of a Markush grouping, and this is not proper. Applicant is advised to replace “... a group consisting of ...” with - - ... the group consisting of ... - - .
Appropriate correction is requested.
Warning for Duplicate Claims
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). 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. Therefore, the plant of claim 5 and the plant of claim 11 are indistinguishable from one another, and this results in a duplicate claim.
Background on the Technology
After reading up on the state of the art for alfalfa breeding, the Examiner believes that alfalfa breeding is quite different when compared to more common diploid plants that are either inbreds or F1 hybrids produced by crossing two inbreds. In order to properly understand the claimed invention, the Examiner sets forth the following findings of fact:
FF1: Alfalfa is naturally crosspollinated by bees and “tolerates comparatively little inbreeding” (Rumbaugh, M. D. “Breeding and Quantitative Genetics” Chapter 25 in Alfalfa and Alfalfa Improvement (1988) Eds. Hanson, Barnes, and Hill; American Society of Agronomy, Inc. Crop Science Society of America, Inc. Soil Science Society of America Inc.; pp. 777-808; page 777).
FF2: Alfalfa has 8 chromosomes and all cultivars are autotetraploids, meaning four copies of each of the eight chromosomes where each of the four copies will readily recombine with one another via cross-over events during sexual propagation, resulting in complex inheritance for economic traits (Id.).
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 (Id. 778).
FF4: 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.” (Id. 780).
FF5: Synthetic cultivars formed from 100 or more clones are expected to be more stable during seed multiplication than narrow based synthetics (Id. 781).
FF6: Most genes for resistance are dominant (Id. 782).
FF7: 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 (Id.).
FF8: 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; pp. 1-8).
FF9: 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, 786 and 803).
FF10: The phenotypic effects of traits in which having different alleles at the same locus (heterozygosity) causes interactions that affect the phenotype and are very complicated and hard to predict (Id. 795-8).
FF11: Populations of alfalfa are rarely, if ever, in random mating equilibrium (RME) (Id. 803).
FF12: 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 (Id. 804-5).
FF13: 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; pp. 1- 15; page 11)
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 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 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
Claim 1 is drawn to a seed of alfalfa variety R0419A3143, wherein representative seed of said alfalfa variety have been deposited under NCMA Accession No. 202210028.
The metes and bounds of the claim are indefinite because it is unclear how any given seed is “representative” of this variety because this synthetic variety encompasses a diverse and very heterogeneous population of alfalfa plants resulting from open pollination of 180 separate parent plants (Spec 6 ¶ 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” (FF #8).
Claims 5, 10, 11, 15, 17, 20, and 21 each require “all of the physiological and morphological characteristics of a plant of said alfalfa variety R0419A3143”, but it is unclear what characteristics of the variety any particular plant within the variety may actually have. Because each individual plant has only a subset of the traits disclosed for the variety, “a plant” of the variety does not possess a defined set of characteristics. In fact, it is highly probable that there are no seeds at all that possess all of the genes necessary to confer all of the characteristics set forth for the variety.
Therefore, the metes and bounds of the claims are indefinite because it is unclear what characteristics of the variety any particular plant within the variety may actually have.
The majority 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, therefore, it is unclear how any given deposited seed would be “representative” of the variety as a whole by either phenotype or by genotype.
With regard to claim 15, specifically, claim 15 recites the limitation "The alfalfa plant produced by the method of claim 14; ..." in line 1. There is insufficient antecedent basis for this limitation in the claim because the method of claim 14 is able to produce an assortment of different alfalfa plants with different transgenes or loci. Applicant is advised to amend to recite - - An alfalfa plant produced by the method of claim 14; ... - - .
Claims 17 and 21 are indefinite because they require that the seed has all of the physiological and morphological characteristics of a seed of alfalfa variety R0419A3143; however, it is unclear what those characteristics are. The instant specification does not provide a definition or description for the physiological and morphological characteristics of a seed of variety R0419A3143. For this reason, the metes and bounds of the claim are not clear.
Claims 15, 17, 20, and 21 are indefinite because they each recite “otherwise comprises all of the physiological and morphological characteristics”, and it is unclear what “otherwise” is referring to.
Claim 25 is indefinite because it is a method, but it does not require any specific active method step. It is, essentially, a method of producing by producing. It is unclear what a practitioner of this method is required to actively do.
Inadequate Written Description
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) 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 claims are directed to seeds and plants of alfalfa variety R0419A3143, and to seeds or plants produced by methods that encompass sexual propagation with alfalfa variety R0419A3143 and methods of introducing locus conversions into said variety (claims 10, 11, 14-23) and a method of producing a synthetic alfalfa variety (claim 24).
As discussed, above, each individual plant or seed will not possess all of the genes/traits that are disclosed for the variety because the synthetic variety encompasses an extremely large genus of plants produced by a random mating open pollination of 180 parental plants.
The variety has been described by characteristics of a large enough group of plants to produce statistics on the distribution of different characteristics. This is a description of the population rather than a description of any individual plant or seed.
Some of the claims are directed to progeny of the synthetic variety, and these have the same issue but are exacerbated by further genetic shuffling. 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 (claims 10-11). 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, and each of these chromosomes will be a random mosaic of DNA from the four chromosomes of the respective parent plants.
Methods that involve backcrossing to introduce a locus conversion are also inadequately described, because they rely upon using a “recurrent parent” (Spec 17-8, ¶ 30; 38 ¶ 104; 43 ¶ 139). It is known in the art that a successful backcross program relies upon a satisfactory recurrent parent which should be an inbred line (Plant and Soil Sciences eLibrary 2023; downloaded on Aug. 26, 2023). Otherwise, the recurrent parent goes through meiosis to produce pollen or an ovule, and the genome is not the same as the genome of variety R0419A3143.
Commercial alfalfa cultivars are mostly synthetic populations formed from a large number of parents. See, for example, Wang et al. (Acta Agriculturae Scandinavica Section B – Soil and Plant Science (2011) Vol. 61; pp. 60-66) who teach that such synthetic varieties have a broad genetic base (Wang 60). In fact 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 (Id. abstract).
Here, the instant variety is produced by a random open pollination of 180 parental plants and thus has a broad genetic base such that back-crossing 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 the original 180-way open pollination.
With regard to claim 24, specifically, the Applicant has not described the production of a new synthetic alfalfa variety. If the claimed method is a simple cross-pollination, then this is not sufficient to arrive at a brand new synthetic variety as many more method steps in accordance with how the instant variety was produced are required and which are not instantly claimed.
For at least these reasons, claims 1-27 are not adequately described across the full breadth of the claims.
Lack of Enablement
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 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.
There is a high degree of indefiniteness regarding what is required for a particular seed or plant to be a member of alfalfa variety R0419A3143; however, one interpretation is that a plant of this variety must have all of the characteristics disclosed in paragraph 20:
Alfalfa variety R0419A3143 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 pea aphid; with resistance to spotted alfalfa aphid and stem nematode. (Spec 6 ¶ 20).
The Applicant has deposited seeds of variety R0419A3143; however, within a population of plants grown from these seeds the vast majority, if not all, of the plants will not have all of the resistances disclosed for variety R0419A3143 (e.g. FF8). Therefore, one of skill in the art would be left to grow multitudes of seeds and screen for any individual plant that possesses these traits, if there is even one such plant to be found. Screening large numbers of plants in the hopes of finding even one that actually possesses all of the resistances disclosed for variety R0419A3143 with no guarantee that one even exists amounts to undue experimentation.
Furthermore, if one of skill in the art were to request seeds from NCMA Accession No. 202210028, then they would receive a package of 25 seeds (NCMA Patent Deposit). 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 R0419A3143”.
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. If Applicant were able to provide a declaration with information about how many seeds would be required to result in a population with the statistical distribution of traits that is characteristic of this variety, and if the number is 625 or less, and if Applicant were to deposit seed packets which each comprise at least 625 seeds, then Applicant would be enabled for a population of at least 625 plants and seeds that together make up a population of the instant invention.
Claims 10 and 11 are directed to a seed and a plant of a first generation progeny alfalfa produced by selfing a plant of variety R0419A3143 or crossing to another plant of variety R0419A3143, wherein the first generation progeny seed and plant have all of the physiological and morphological characteristics of a seed and plant of alfalfa variety R0419A3143.
Claim 17 is directed to a seed that produces an alfalfa plant made by introducing a transgene or a single locus conversion into a plant of alfalfa variety R0419A3143, wherein the plant comprising the transgene or single locus conversion otherwise comprises all of the physiological and morphological characteristics of variety R0419A3143.
Claim 20 is directed to an alfalfa plant produced by crossing a plant of variety R0419A3143 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 R0419A3143, and 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 R0419A3143.
As discussed above in the indefiniteness rejection, it is unclear what “all of the physiological and morphological characteristics of variety R0419A3143” are. However, if this requirement means that these plants must have all of the resistances listed in paragraph 20, then the claims are not enabled for the reasons already stated, above.
Every one of these claims requires sexual reproduction that results in the production of a seed. As discussed, above, in the written description rejection, the instant variety, variety R0419A3143, is a “synthetic” variety produced by open pollination of 180 different parental plants.
For this reason, the four copies of each chromosome within any given plant of variety R0419A3143 are quite 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 R0419A3143 would grow into a plant having all of the characteristics of variety R0419A3143.
The Examiner provided references teaching these issues with the genetics of alfalfa in the written description rejection, above. 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.
Applicants do not teach that variety R0419A3143 is a true-breeding inbred variety.
For example, the state-of-the-art shows that the goal of backcrossing is to recover the genome of the recurrent parent see, for example, Chukwu et al. (Plants (2020) Vol. 9; pp. 1-15). Chukwu et al teach that the percentage of the parent genome recovery (RPGR) 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. 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 (Id. 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 discussed 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.
Failure to Further Limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 depends from claim 2 which is directed to a plant grown from a seed of alfalfa variety R0419A3143 or a part thereof wherein the part comprises at least one cell of the variety. Claim 3 is directed to a tissue culture of cells or protoplasts “from” the plant or plant art of claim 2. Claim 4 recites a list of plant parts many of which encompass cells of the next generation which is formed after the flowers of the plant have been pollinated. Claim 4 includes “embryos” which necessarily would NOT comprise a cell of alfalfa variety R0419A3143 (the maternal plant) because the embryo does not retain maternal cells. For this reason, claims 3-5 are broader than claim 2 from which they depend (either directly or indirectly).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Anticipation/Obviousness over US Patent No. 11, 252,927
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Rodgers et al. (US Patent No. 11,252,927; issued on Feb. 22, 2022).
The claim language is almost identical with the exception that the name of the alfalfa variety differs and the accession number for the deposited seed differs.
Rodgers teaches alfalfa variety C0516A3154 which shares identical traits (Spec 6, Rodgers col 4) with the exception of the Roundup Ready Event J-101 being present in the instant variety and absent in Rodgers’ variety. The breeding program is also almost identical (Id.), with the only difference being the instant variety breeding program began with 180 parent plants each of which contained the J-101 event and Rodgers’ variety breeding program began with 220 parent plants and is silent about presence/absence of the J-101 event.
As discussed, above, it is unclear what is required for an individual plant or seed to be a member of variety R0419A3143, 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 R0419A3143. However, if even one seed from the Rodgers deposit grows into a plant that is indistinguishable from one member of the genus of plants encompassed by the instant claims, then Rodgers anticipates the claims.
The instant synthetic variety R0419A3143 encompasses a population of plants having 98% purple flowers, 1% cream flowers, with a trace of variegated flowers, yellow, and white flowers. The prior art synthetic variety encompasses a population of plants having 98% purple flowers, 1% variegated flowers, with a trace of cream, yellow, and white flowers. The instant claims are directed to a single plant or a single seed, therefore a plant with any one of those flower colors is included in the claimed variety.
In the event there not one single plant in the population of Rodgers’ prior art plants that comprises at least one copy of the J-101 event AND if the instant variety requires every one of the plants to contain at least one copy of the J-101 event and if every seed deposited for the variety contains at least one copy of the J-101 event, then it would have been obvious to introgress this event because Rodgers claims their plant with a single locus converted (Rodgers claim 14-5, including wherein the converted locus confers herbicide tolerance (Id. claim 16), and Rodgers expressly suggests the J-101 event and discloses this event is disclosed in US Patent No. 7,566,817 (Id. col. 18). The Examiner takes official notice that the J-101 event conferring resistance to roundup was well known and routinely used at the time of filing. The Examiner does not have laboratory facilities to test the prior art population of plants to determine if a single one has the J-101 event, therefore the burden shifts to the Applicant to provide evidence that the event is not present in the prior art plant, and provide evidence or rationale as to why introgressing the event would not have been obvious.
The variety encompasses a diverse genus of plants that make up a population with the statistical distribution of traits that characterize the variety (FF#2 – FF#8 and FF#14, and distribution of flower colors discussed, above). Because the instant claims are directed to a single individual plant or seed that is a member of the variety, if even one of the plants encompassed by the claims in the prior art falls within the genus of the instant variety, that prior art plant would anticipate the instant claims.
For these reasons the prior art taught by Rodgers either anticipates or renders obvious the instant claims.
Anticipation/Obviousness over US 2020/0229382
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Pre-Grant Publication US 2020/0229382; published on July 23, 2020).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants and also had parents that each contained the J-101 event, and McCaslin’s percentages are different.
Anticipation/Obviousness over US Patent No. 10,827,717 B2
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Reisen et al. (US Patent No. 10,827,717 B2; issued on Nov. 10, 2020).
The analysis is almost identical as the one above, with the exception that Reisen’s alfalfa variety had a different number of parent plants and also had parents that each contained the J-101 event, and Reisen’s percentages are different.
Anticipation/Obviousness over US Patent No. 10,925,247 B2
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Patent No. 10,925,247 B2; issued on Feb. 23, 2021).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants and also had parents that each contained the J-101 event, and McCaslin’s percentages are different.
Anticipation/Obviousness over US Patent No. 10,736,297 B1
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Patent No. 10,736,291 B1; issued on Aug. 11, 2020).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants and also had parents that each contained the J-101 event, and McCaslin’s percentages are different.
Anticipation/Obviousness over US 2019/0269094 A1
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Pre-Grant Publication US 2019; published on Sep. 5, 2019).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants and also had parents that each contained the J-101 event, and McCaslin’s percentages are different.
Anticipation/Obviousness over US Patent No. 10,531,630 B2
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Patent No. 10,531,630 B2; issued on Jan. 14, 2020).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants, and McCaslin’s percentages are different.
Anticipation/Obviousness over US Patent No. 10,531,632 B2
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Patent No. 10,531,632 B2; issued on Jan. 14, 2020).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants, and McCaslin’s percentages are different.
Anticipation/Obviousness over US Patent No. 10,555,493 B2
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Patent No. 10,555,493 B2; issued on Feb. 11, 2020).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants and also had parents that each contained the J-101 event, and McCaslin’s percentages are different.
Anticipation/Obviousness over US Patent No. 10,531,631 B2
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Patent No. 10,531,631 B2; issued on Jan. 14, 2020).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants, and McCaslin’s percentages are different.
Anticipation/Obviousness over US Patent No. 10,555,496 B2
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Patent No. 10,555,496 B2; issued on Feb. 11, 2020).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants and also had parents that each contained the J-101 event, and McCaslin’s percentages are different.
Anticipation/Obviousness over US Patent No. 10,485,214 B2
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Patent No. 10,485,214 B2; issued on Nov. 26, 2019).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants and also had parents that each contained the J-101 event, and McCaslin’s percentages are different.
Anticipation/Obviousness over US Patent No. 10,412,925 B1
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Patent No. 10,412,925 B1; issued on Sep. 17, 2019).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants and also had parents that each contained the J-101 event, and McCaslin’s percentages are different.
Anticipation/Obviousness over US Patent No. 10,357,011 B1
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Patent No. 10,357,011 B1; issued on July 23, 2019).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants and also had parents that each contained the J-101 event, and McCaslin’s percentages are different.
Anticipation/Obviousness over US Patent No. 10,342,209 B1
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Patent No. 10,342,209 B1; issued on Sep. 17, 2019).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants and also had parents that each contained the J-101 event, and McCaslin’s percentages are different.
Anticipation/Obviousness over US Patent No. 10,342,208 B1
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Patent No. 10,342,208 B1; issued on July 9, 2019).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants and also had parents that each contained the J-101 event, and McCaslin’s percentages are different.
Anticipation/Obviousness over US Patent No. 10,327,412 B1
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Patent No. 10,327,412 B1; issued on July 25, 2019).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants and also had parents that each contained the J-101 event, and McCaslin’s percentages are different.
Anticipation/Obviousness over US Patent No. 10,314,279 B1
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al. (US Patent No. 10,314,279 B1; issued on June 11, 2019).
The analysis is almost identical as the one above, with the exception that McCaslin’s alfalfa variety had a different number of parent plants and also had parents that each contained the J-101 event, and McCaslin’s percentages are different.
Double Patenting – Statutory or Non-Statutory
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
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 under 35 U.S.C. 101 as claiming the same invention as that of claims 1-27 of each of prior U.S. Patent Nos:
11,252,927;
10,827,717;
10,925,247;
10,736,297;
10,531,630;
10,531,632;
10,555,493;
10,531,631;
10,555,496;
10,485,214;
10,412,925;
10,357,011;
10,342,209;
10,342,208;
10,327,412; and
10,314,279,
or, in the alternative on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of each of U.S. Patent Nos. 11,252,927; 10,827,717; 10,925,247; 10,736,297; 10,531,630; 10,531,632; 10,555,493; 10,531,631; 10,555,496; 10,485,214; 10,412,925; 10,357,011; 10,342,209; 10,342,208; 10,327,412; and 10,314,279. See analysis and mapping of limitations in the rejection under 35 USC 102/103, above.
Provisional Double Patenting over 18/115,143
Claims 1-27 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-27 of copending Application No. 18/115,143 (reference application; published as US 2024/0284852 A1) or in the alternative on the ground of nonstatutory double patenting as being unpatentable over claims1-27 of copending Application No. 18/115,144 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim language is almost identical with the exception of the variety name and accession number for deposited seeds. The analysis and breeding history is the same as the 102/103 rejection over 10,827,717, above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Provisional Double Patenting over 18/115,144
Claims 1-27 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-27 of copending Application No. 18/115,144 (reference application; published as US 2024/0284853 A1) or in the alternative on the ground of nonstatutory double patenting as being unpatentable over claims1-27 of copending Application No. 18/115,144 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim language is almost identical with the exception of the variety name and accession number for deposited seeds. The analysis and breeding history is the same as the 102/103 rejection over 10,827,717, above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Provisional Double Patenting over 18/115,146
Claims 1-27 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-27 of copending Application No. 18/115,146 (reference application; published as US 2024/0284854 A1) or in the alternative on the ground of nonstatutory double patenting as being unpatentable over claims1-27 of copending Application No. 18/115,146 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim language is almost identical with the exception of the variety name and accession number for deposited seeds. The analysis and breeding history is the same as the 102/103 rejection over 11,252,927, above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Provisional Double Patenting over 18/115,147
Claims 1-27 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-27 of copending Application No. 18/115,147 (reference application; published as US 2024/0284855 A1) or in the alternative on the ground of nonstatutory double patenting as being unpatentable over claims1-27 of copending Application No. 18/115,147 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim language is almost identical with the exception of the variety name and accession number for deposited seeds. The analysis and breeding history is the same as the 102/103 rejection over 11,252,927, above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Provisional Double Patenting over 18/115,147
Claims 1-27 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-27 of copending Application No. 18/588,299 (reference application; published as US 2025/0268217 A1) or in the alternative on the ground of nonstatutory double patenting as being unpatentable over claims1-27 of copending Application No. 18/588,299 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim language is almost identical with the exception of the variety name and accession number for deposited seeds. The analysis and breeding history is the same as the 102/103 rejection over 11,252,927, above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shubo "Joe" Zhou can be reached at (571) 272-0724. The fax phone number for the organization