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 1-8, 10-20 and 22 are pending and examined on their merit herein.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 13-20 and 22 rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claim 13 recites a method which is one of the eligible categories under 101.
Claim 13 recites the steps of identifying a Brassica plant comprising in its genome an A09 resistance locus and selecting a plant comprising said A09 resistance locus.
The steps of identifying and selecting a plant falls into the “mental process” grouping of abstract ideas because the identifying and selecting processes can be practically performed in the human mind. The claims further recite a law of nature because it describes the naturally occurring relationship between a plant’s genotype and phenotype. Therefore, the claims are directed to the judicial exception because the limitations of isolating and assaying NA are mere data gathering. The limitation is insignificant extra-solution activity. (Step 2A: Yes)
This judicial exception is not integrated into a practical application because the recited “producing a clubroot resistant Brassica plant” in the preamble merely states the intention of the claimed process. This limitation therefore remains insignificant extra-solution activity and does not amount to significantly more. (Step 2B: No.)
Therefore, claim 13 does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The analysis is now turning to the dependent claims.
Claims 14-19 merely further specify the loci to be identified. Claims 20 and 220 merely explain the status or nature of the loci to be identified. These claims do not recite additional elements that are sufficient to amount to significantly more than the abstract idea/mental process which is a judicial exception.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 1-8, 10-20 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The Federal Circuit has clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials". University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not description of that material". Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus". Id.
The claims broadly requiring the “A09 resistance locus”, to have the specific functional activity of conferring resistance to pathogen Plasmodiophora brassicae (P. brassicae) in any Brassica plant. The “A09 resistance locus” is merely defined as being located in the interval from about 28.7 to about 41.5 Mb of A09 (chromosome), or between about 38.01 -41.5 Mb of A09, or 28.7-37.3 Mb.
The scope of the “A09 resistance locus” is broad. Firstly, it encompasses the A09 (or A9, 9A) chromosome (or its equivalent) in any Brassica plant. Even if “Brassica plant” is interpreted as plants belonging to the Genus Brassica which comprises at least 37 species (in contrast to the Family Brassicaceae with over 3700 species; See Encyclopedia Britanica). These range from B. assyriaca, B. carinata, to B. tyrrhena, B. villosa, including B. napus, B. rapa, and B. oleracea. It should be noted that some species do not have A chromosomes.
Secondly, the interval, even at the narrowest, encompass ~10 million nucleotides or longer (due to the divergence among the diverse species, discussed later). Such a region would comprise hundreds if not thousands of genes and numerous other genetic elements (see overview in, for example, Wu J, et al. (2022) Front. Plant Sci. 13:936958, which teaches comparative genome assembly in winder rapeseed (B. rapa)).
In contrast to the broad scope of the claims, Applicant has described recombinant inbred lines (RILs) derived from an initial cross of a clubroot-resistant B. rapa var. rapifera turnip accession of the European Clubroot Differential (ECD) set (accession ECD 01 or cv. Debra), and a clubroot susceptible spring B. napus; and near-isogenic lines (NILs) with one of the advanced generation canola lines derived from the (B. napus A04-73NA x B. rapa turnip) x B. napus interspecific cross carrying resistance to P. brassicae pathotypes 3A and 3H crossed to the B. napus parent A04-73NA; and mapping of the clubroot resistance loci using these materials, and SNPs based on Reference genome B. rapa cv. Chiffu-401 whole genome assembly v3.0 (Examples).
Applicant has described that a major resistance locus is mapped to (according to the reference genome and the SNP markers) chromosome A09 between “37 to 43 Mb region of A09” ([00205]) or 38.01 to 41.5 Mb (Table 5).
It appears, Applicant has described that a genetic factor–the contributing factor for the clubroot resistance—from a specific plant species and cultivar, namely, turnip accession ECD 01 or cv. Debra, when introgressed into a hybrid or progeny thereof with B. napus, would map to a position corresponding to the B. rapa cv. Chiffu-401 reference genome according to a specific version (3.0), which is “interval from about 28.7 to about 41.5 Mb of A09” (the “A09 resistance locus”).
Applicant has not described the genetic factors conferring clubroot resistance. Applicant has not described the structural features of the genetic factors conferring clubroot resistance. The mere description of a location is not sufficient since not all of the A09 chromosomes in all Brassica plants have the same identical genetic material in that location, e.g., “37 to 43 Mb region of A09”. Of all the Brassica plants, species, varieties, cultivars, accessions, or ecotypes, it is not clear whether or which of them have the clubroot resistance or whether the corresponding “37 to 43 Mb region of A09” would confer clubroot resistance. The specification fails to sufficiently describe the necessary structural features that must be retained by a genomic region as to establish a structure-function relationship with respect to the specific function of conferring clubroot resistance.
Applicant has not described identifying features for the broadly claimed “A09 resistance locus”. While the Specification has cited some SNP markers, e.g., “Bn-A09-p23724105”, there is no description of the markers, such as the nucleotide sequence and/or favorable alleles that are associated with the resistance trait. Furthermore, the markers appear to be of B. napus genomic source, it is not clear that they would be identifiable in the genetic material that contributes the clubroot resistance, namely turnip Accession ECD-01.
Even within the confine of the narrow embodiments of “A09 resistance locus” originated from turnip Accession ECD-01, Applicant, or the state of the art at the time of filing of the instant application, has described the structural features or elements conferring the required clubroot resistance. For example, Kaur (Int J Mol Sci. 2025 Sep 19;26(18):9157) teaches (NILs) of B. napus, carrying the resistance of turnip (B. rapa var. rapifera), developed by crossing a clubroot-resistant B. napus line carrying resistance introgressed from B. rapa ECD 01 (cv. Debra) and a clubroot-susceptible B. napus canola line A04-73NA (Materials and Methods, Section 6.1), i.e., the same as the instantly disclosed. Kaur teaches the identification of some of the key genes potentially involved in maintaining cell wall integrity and modulating plant growth and defense mechanisms, including PECTIN METHYLESTERASE INHIBITOR, KELCH MOTIF, and LACCASE, genes related to antioxidant responses, such as G6PDH, GST, CATALASES, and 4-HPPD, and the potential role of ROS detoxification in resistance. These findings suggest that resistance in B. napus against P. brassicae is likely mediated by ROS-mediated signaling and reinforcement of the cell wall (Conclusions). However, many of the “key genes” identified therein are not localized in the instantly claimed “A09 resistance locus” or on A09 chromosome at all. For example, the “PECTIN METHYLESTERASE INHIBITOR” BnaA04T0284100WE appears to be located on chromosome A04. Many other “key genes” are located on A04, A01, A03, C04, etc. (Abstract). Kaur also cautioned that small-scale genomic differences between the cultivars, such as single-nucleotide polymorphisms, insertions, and deletions, could affect the precision of integrated transcriptome-proteome analysis (p. 17). To this end, Applicant has not addressed the nature of the “A09 resistance locus” from the donor material as compared with the susceptible B. napus chromosome.
Therefore, Applicants have not adequately described the structural features that are required to be retained by members of the claimed genus as to establish a structure-function relationship, or the structural features required to distinguish members of the claimed genus from other chemical structures.
The analysis will now turn to the second element of the court’s decision in Eli Lilly; namely, the description of a representative number of species. As discussed above, the broadly claimed genus of “A09 resistance locus” is enormous in size and contain numerous differences—subtle or otherwise—among the many Brassica species, cultivars, or isolates.
Given the virtually infinite structural variable associated with these embodiments, the claims read on an extremely broad and highly diverse structures. Thus, in view of the analysis presented above, a skilled artisan would appreciate that the claims are directed to extremely broad and highly diverge genus of “A09 resistance locus” that are required to have the specific function of conferring clubroot resistance.
Given the large size and structural diversity associated with the claimed genus, Applicant’s disclosure is not representative of the claimed genus as a whole. This point is particularly relevant because, as discussed above, the prior art speaks to the disconnection between the structure of the broadly claimed variants and the recited specific function.
Thus, based on the analysis above, Applicant has not met either of the two elements of the written description requirement as set forth in the court's decision in Eli Lilly. As a result, it is not clear that Applicant was in possession of the claimed genus at the time this application was filed.
Enablement
Claims 1-8, 10-20 and 22 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.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
The breadth of the claims and the relavant teachings from the instant disclosure are discussed supra.
Applicant has not provided enabling guidance for making, or identifying, P. brassicae resistant Brassica plant cell comprising the broad genus of “A09 resistance locus”. Especially, Applicant has not provided enabling guidance regarding identifying such loci. For example, the Specification recites SNP markers, e.g., “Bn-A09-p23724105”, there is no description of the markers, such as the nucleotide sequence and/or favorable alleles that are associated with the resistance trait. Furthermore, the markers appear to be of B. napus genomic source, it is not clear that they would be identifiable in the genetic material that contributes the clubroot resistance, namely turnip Accession ECD-01.
Secondly, without any enabling guidance on identifying the members of the broad genus of “A09 resistance locus”, the making of the claimed plants are not enabled. It is unpredictable whether any chromosomal fragments of, e.g., from about 28.7 to 41.5 Mb, or from about 38.01 -41.5 Mb, of any A09 chromosome from any of the numerous Brassica plant species, cultivars, isolates, lines, accessions, or ecotypes, or hybrids thereof.
In the absence of guidance from either the instant disclosure or the art, it would require trial and error experimentation for a skilled artisan to identify any chromosomal fragments of, e.g., from about 28.7 to 41.5 Mb, or from about 38.01 -41.5 Mb, of any A09 chromosome from any of the numerous Brassica plant species, cultivars, isolates, lines, accessions, or ecotypes, or hybrids thereof, for their ability to confer resistance to any clubfoot pathogen or specific pathotypes, with no reasonable predictability for success.
For at least this reason, the Specification does not teach a person with skill in the art how to make and/or use the subject matter within the full scope of these Claims.
Claim Rejections - 35 USC § 102
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.
Claims 1-8 and 10-12 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Yu (Front Plant Sci. 2022 Jan 12;12:785989).
Claims 1-8 and 10-12 are drawn to a Plasmodiophora brassicae (P. brassicae) resistant Brassica plant cell comprising in its genome an A09 resistance locus comprising the interval from about 28.7 to about 41.5 Mb of A09;
Or about 38.01 -41.5 Mb of A09; or 28.7-37.3 Mb of A09;
Or further comprising an A03 resistance locus comprising the interval from about 1.7 to about 14.5 Mb of A03, an A02 resistance locus comprising the interval from about 1 to about 4 Mb of A02, or an A08 resistance locus comprising the interval from about 14.34 Mb to about 20.87 Mb of A08.
As disclosed, these “resistance locus” of A09, A03, A02, or A08, are genomic fragments from a clubroot-resistant B. rapa var. rapifera turnip accession of the European Clubroot Differential (ECD) set: accession ECD 01 or cv. Debra.
The recited Brassica plant is interpreted as any plant in the genus Brassica or derivative thereof such as interspecific hybrids, since interspecific hybridization is a common and important evolutionary mechanism in the Brassicaceae family (see for example, Sohn, Genes 2022, 13, 1442).
As such, Yu disclosed F1 plants of interspecific cross of ECD01 with B. napus line DH16516, therefore also cells, seeds, etc., thereof.
Since the F1 plant would have to contain one set of chromosomes from the resistant parent ECD01, it must inherently contain all or any of the instantly recited “resistance locus” of A09, A03, A02, or A08.
Therefore, the claimed plant cell, plant, or seed, are anticipated by the prior art.
Conclusion
No claims are allowed.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663
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