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 .
Application Transfer
The application has been transferred to Patent Examiner Yvette Tamukong in Art Unit 1662. Any inconvenience to Applicants is regretted.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The certified copy (Certified Copy of Foreign Priority Application) has been filed on 01/19/2024. The effective filing date is 7/23/2021.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-8, 15, 19-21 and 23, in the reply filed on 09/30/2025 is acknowledged. The traversal is on the ground(s) that technical feature linking Groups I-III is a special technical feature, and that there is no search and/ or examination burden to consider the groups together (see Applicant Remarks page 2).
This is not found persuasive because the Requirement for Restriction put forth that technical feature is not a special technical
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-12, withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/30/2025.
As a courtesy to Applicant an in the interest of compact prosecution the species of SEQ ID NOs 1, 4, 5, 44, and 45 have been rejoined effectively withdrawing the species election requirement.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/20/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
Preliminary Amendment dated 09/30/2024 is entered.
Claims are cancelled without prejudice or disclaimer.
Claims 1-8, is/are pending.
Claims 11-12, withdrawn.
Claims examined herein.
Claim Rejections - 35 USC § 112(a)
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.
Written Description
Claims 1-7 rejected under 35 U.S.C. 112(a)
Claims 1-7, 15, 19-21 and 23 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 contain a limitation that overcomes the deficiencies of the parent claim from which they depend.
The following is a quotation of the specification (page 18, lines 4-5):
The term "plant" as used herein preferably refers to Brassicaceae plant, such as a Brassica 5 plant.
The use of "preferably" does not automatically limit the claims’ scope of what plant is. Claim 8 carries the only effective limitation of plant to Brassicaceae plants, such that claims 1-7 are broadly drawn to all possible plants.
The claims 1-7 are broadly drawn to methods for producing a blackleg resistant plant comprising introducing into the genome of a plant(a broad genus including all possible plant species) at least one polynucleotide comprising blackleg resistance locus Rlm3 or a polynucleotide encoding an Rlm3 associated open reading frame wherein the polynucleotide is at least 80% identical to the nucleic acid sequence shown in any one of SEQ ID NOs: 1, 4, 42 and 44, identifying plants having integrated the polynucleotide(s) into their genomes, and generating progeny from them OR genetically modifying a plant genome to such that it is able to express polypeptides encoded by polynucleotides comprising blackleg resistance locus Rlm3 or polynucleotides encoding an Rlm3 associated open reading frame, wherein homologous recombination or a genome editing technology is used.
The Specification describes Blackleg, a major disease of Brassica napus L., as being caused by the fungal pathogen Leptosphaeria maculans adding that resistance against the fungal pathogen is governed largely by race specific R-genes including Rlm3 (page 1 ).
Applicant describes the identification of Rlm3 black leg resistance genes ( Example 1, page 43).
Applicant validates Rlm3 in loss-of-function approach by mutagenizing the seeds of “a resistant elite spring oilseed rape breeding line”, (i.e., a Brassica plant), infecting mutagenized offspring possessing STOP codon mutations in Rlm3 genes with one race, Leptosphaeria maculans Isolate Lml033-1 and characterizing the resistance phenotypes show that gene 19, the longest Rlm3 gene, is required for blackleg resistance(Example 2).
Applicant describes the annotation of Rlm3 proteins (Example 3).
Applicant describes the validation Rlm3 in a transgenic approach whereby applicant transformed the Brassica napus cultivars, Westar and/or Darmor, which are susceptible to blackleg with the Rlm3 coding sequences or genomic regions and characterizing the transformed plants as showing increases blackleg resistance compared to untransformed counterparts (Example 4).
Applicant describes transfer of Rlm3 into other Brassicaceae breeding lines (Example 5),
Applicant describes a PCR assay design to assay the sequences of Rlm3, Gene 19 (Example 6).
Applicant describes validation of Rlm3 in protoplast assays whereby protoplasts are isolated from a blackleg resistant and a blackleg susceptible Brassica napus cultivar and respectively transfected with expression vectors carrying avirulence genes and expression vectors carrying avirulence genes Rlm3 coding sequences (Example 7).
Applicant has only reduced to practice methods for producing a blackleg resistant plant in a single species, Brassica napus, or a limited number of species within a narrow genus (Examples 4, 5, and 7). While the claims recite a method of producing a blackleg resistant plant applicable to 'all possible plants,' the specification (e.g., at page 1 lines 9-28, page 11 line 4, page 19 lines 5-9, and page 21 line 22 to page 22 line 15, and Examples 4, 5, and 7) only provides working examples and specific details of the production a blackleg resistant Brassica plants.
This disclosure of a single genus is not a representative number of examples sufficient to demonstrate that the inventor was in possession of the entire genus of 'all possible plants' as required by the statute.
Further, the specification indicates that the Rlm3 gene provides "race-specific resistance" (page 2, lines 1-13) while Larkan teaches that the functionality of Rlm3 can be influenced by interactions with other genes ( “Recognition of both AvrLm3 and AvrLm5-9 by Rlm3 and Rlm9, respectively, is masked in the presence of AvrLm4-7.” (page 893, col 1, para 2). This inherent limitation further highlights the narrow applicability and the unpredictability of Rlm3’s blackleg resistance function across different plant species, genus, family orders that encompass “all possible plants” and varying pathogen races. This reinforces, that at the time of filing, the descriptions in the specification would not reasonably convey to one skilled in the relevant art that applicant had possession of the claimed invention(s).
Regarding claims 3-4, 6, 15, 19-21 and 23, applicant has only reduced to practice and provided specific working examples of methods for producing a blackleg resistant plant in a single species, Brassica napus, using full length sequences of SEQ ID NOs 1, 4 and 42 (Examples 4, 5, and 7) yet claims methods for producing a blackleg resistant plant or compositions comprising partial sequences of a polypeptide comprising an amino acid sequence as shown in anyone of SEQ ID NOs: 5, 43, and 45 OR.
The Specification fails to provide an adequate written description to support the breadth of the claims. Therefore, one skilled in the art would not have recognized Applicants to be in possession of the claimed invention at the time the application was filed. See Written Description guidelines published in 2008 online at https://www.uspto.gov/ sites/default/files/web/menu/written.pdf.
Scope of Enablement
Claims 1-7, 15, 19-21 and 23 are rejected under 35 U.S.C. 112(a)
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for producing a blackleg resistant plant in a single species, Brassica napus, or a limited number of species within a narrow genus, does not reasonably provide enablement for producing a blackleg resistant plant of 'all possible plants'. All dependent claims are included in these rejections unless they contain a limitation that overcomes the deficiencies of the parent claim from which they depend.
Applicant has only provided specific working examples of methods for producing a blackleg resistant plant in a single species, Brassica napus, or a limited number of species within a narrow genus (Examples 4, 5, and 7). The unpredictability of Rlm3’s blackleg resistance function across different plant species, genus, family orders that encompass “all possible plants” and varying pathogen races further reinforces, that at the time of filing, specification does not enable one skilled in the relevant art to produce a blackleg resistant plant of “all possible plants” as claimed.
Claims 3-4, 6, 15, 19-21 and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a p, does not reasonably provide enablement for a p. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims. Applicants have reduced to practice complete splice variant sequences yet claim a partial sequence of recited sequences. How has applicant ascertained which percentage of sequence identity to relevant SEQ ID NOs is sufficient to confer black leg resistance to a plant. Additionally, “a partial sequence of (recited sequences)” encompasses an indefinite number of potential fragments, making the scope of the claim unclear. The structure function relationship of Rlm genes is not adequately established by the prior art. However, Rlm genes are already known to be race specific (Larkan). Consequently, partial sequences of the coding region or poly peptide have unpredictable effects on the race specificity of blackleg resistance. Thus, identifying how many nucleotides (monomer, dimer, tetramer?) or which nucleotides along the length of the sequence comprise a polypeptide capable of conferring blackleg resistance to a plant will require undue experimentation by a person having ordinary skill in the art. All dependent claims are included in these rejections unless they contain a limitation that overcomes the deficiencies of the parent claim from which they depend.
Claim Rejections - 35 USC § 112(b)
Claims 6 and 7 are rejected under 35 U.S.C. 112(b).
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.
Claim 6 is 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 contain a limitation that overcomes the deficiencies of the parent claim from which they depend.
Claim 6 is partially recited below for examination purposes:
A method of conferring blackleg resistance to a plant comprising genetically modifying a silent allele of a gene encoding a polypeptide comprising a Rlm3 associated open reading frame such that the silent allele is capable of expressing said polypeptide, wherein said Rlm3 associated open reading frame encodes a polypeptide comprising an amino acid sequence selected from:….
The term “silent allele” is included in the claim language and the specification recites that “the term ‘silent allele’ as used herein refers to an allele which does not confer blackleg resistance [and] can differ from the Rlm3 allele in that the gene is absent, the gene is not expressed, or the gene encodes a different protein” (page 21, lines 1-3).
Applicant is claiming a method of conferring black leg resistance to a plant comprising genetically modifying “an allele [of a gene encoding a polypeptide comprising a Rlm3 associated open reading frame] which does not confer blackleg resistance… differ[ing] from the Rlm3 allele in that the gene is absent, the gene is not expressed, or the gene encodes a different protein” such that the “allele which does not confer blackleg resistance” (i.e., silent allele) is capable of expressing a polypeptide comprising a Rlm3 associated open reading frame, wherein said polypeptide comprises an amino acid sequence which is at least 80% identical to the amino acid sequence of SEQ ID NO: 43 wherein said polypeptide is capable of conferring blackleg resistance to a plant.
First, it is unclear whether the alternative limitations recited in subparts a-d of claim 6 are to apply to the starting material or the product of the claim or both. How can a silent allele the encode a polypeptide comprising a Rlm3 associated open reading frame? What does “Rlm3 associated open reading frame” mean in regards to a silent allele?
Second, Even though the claim uses the same term “silent allele” as in the specification, the scope of the term in the claim is not understood when read in light of the specification. Claim 6 recites silent allele with the modifier “of a gene encoding a polypeptide comprising a Rlm3 associated open reading frame” perhaps to limit the silent allele to a Rlm3 associated open reading frame. But this contradicts the definition recited in the specification (“the silent allele can differ from the Rlm3 allele in that the gene encodes a different protein”) with no quantifications of the difference.
In the interest of compact prosecution, claim 6 (and dependent claim 7) is/are given the broadest reasonable interpretation where in the limitations of parts a-d of the claim apply only to the genetically modified plant which has been conferred blackleg resistance.
Claim Rejections - 35 USC § 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Larkan (Larkan et al (2020), The Brassica napus wall-associated kinase-like (WAKL) gene Rlm9 provides race-specific blackleg resistance. Plant J., 104: 892-900. https://doi.org/10.1111/tpj.14966. published 07/14/2020) in view of NCBI accession XM_018589549.1 and the peptide derived thereof, XP_018445051.1 (both made available on NCBI by 06/14/2016), and NCBI sequence accession AAL61927.1 (made available on NCBI by 01/20/2002).
Regarding claims 1, 3, 5-6, and 8, Larkan teaches that “the Brassica R genes Rlm3, Rlm4, Rlm7 and Rlm9 confer race-specific resistance against blackleg disease caused by L. Maculans [and] form a tight genetic cluster [at approximately 16 Mb] on chromosome A07 and may possibly be allelic variants of the same R locus” (p893, col 1, para 2-3). Larkan also teaches that “Rlm9 encodes a wall-associated kinase-like protein”(WAKL), “showing the highest homology to A. thaliana WAKL10 (At1g79680, 69% amino acid identity). (p893, col 1-2, para 3). Larkan teaches a method of producing blackleg resistant transgenic plants by transferring Rlm9, a WAKL10-homologous gene, into susceptible brassica napus plants (i.e., introducing into the genome of a plant at least one polynucleotide comprising a blackleg resistance locus or blackleg resistance associated open reading frame, wherein said plant is a Brassicaceae plant).
Larkan does not explicitly teach nucleic acid sequences which are at least 80% identical to the nucleic acid sequences shown in SEQ ID NO: 42 and SEQ ID NO: 43.
NCBI Accession AAL61927.1 teaches the amino acid identity of A. thaliana WAKL10 (At1g79680)
NCBI Accession AAL61927.1 does not explicitly teach nucleic acid sequences which are at least 80% identical to the nucleic acid sequences of SEQ ID NO: 42 nor SEQ ID NO: 43.
However, NCBI Accession XM_018589549.1 is the downstream product of whole genome sequencing and teaches a predicted mRNA sequence in Raphanus sativus encoding a “wall-associated receptor kinase-like 10”(WAKL10) that is 86.28% (i.e., at least 80% ) identical to the sequence of SEQ ID NO: 42 (Data not shown). Raphanus sativus and Brassica napus are both members of the Brassicaceae family, which includes various vegetables and oilseed. Additionally, NCBI Accession XP_018445051.1 is the peptide derived from XM_018589549.1 and teaches a peptide sequence that is 83.29% (i.e., at least 80% ) identical to the amino acid sequence of SEQ ID NO: 43 (data not shown). XM_018589549.1 is located in the 17 MB region (see the annotation below) of the scaffold produced by whole genome sequencing (WGS), a method that typically produces contiguous chromosomes.
PNG
media_image1.png
699
1212
media_image1.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art before the filing of the claimed invention to combine the teachings of Larkan with the whole genome sequence of Raphanus sativus to occur upon the instant invention because:
Larkan teaches identifying brassica genes “showing the highest homology to A. thaliana WAKL10 (At1g79680…).”
NCBI blast of the At1g79680 encoded amino acid sequence (NCBI Accession AAL61927.1) against brassica genomes including Raphanus sativus teaches that XP_018445051.1 shows 71.14% homology with it and is a predicted WAKL10 ( see red arrow in annotation below).
PNG
media_image2.png
931
1297
media_image2.png
Greyscale
Larkan also teaches transferring an identified At1g79680-highly-homologous gene into a Brassicaceae plant genome to create transgenic plants resistant to blackleg.
Larkan also suggests that “with the cloning of Rlm9 and the characterisation of the gene as a WAKL we now have the basis for possibly identifying the other three blackleg R genes within the Rlm3/4/7/9 cluster, co-located on chromosome A07 (page 897, para 2). One would have been motivated to this based on the above teachings and suggestion in order to Identify the sequence of other blackleg resistance genes and more efficiently introduce them into desirable but susceptible cultivars as did Larkan.
Regarding claims 2 and 4, which are respectively dependent from claims 1 and 3 with the further limitation that the methods comprise the introduction of a first polynucleotide having at least 80% identical to the nucleic acid sequence SEQ ID NO: 4 and a second polynucleotide having at least 80% identical to the nucleic acid sequence SEQ ID NO: 44, XM_018589549.1 teaches polynucleotides having a nucleic acid sequence which are 85.98% and 91.81% (i.e., at least 80%) identical to the nucleic acid sequences of SEQ ID NO: 4 and SEQ ID NO: 44, respectively. Further, gene stacking was well known in the art at the time of filing.
Regarding claim 5, Larkan teaches the use of droplet digital PCR (ddPCR) in assessing insertion copy number in the T0 and “T1 plants derived from the transgenic line NLA68” (i.e., identifying a plant having integrated into its genome the polynucleotide comprising the blackleg resistance locus) and that a T1 plant carrying the insertion was self-fertilized to produce T2 seed the plants which showed stable expression of the Rlm9 resistance phenotype (i.e., generating progeny from said plant wherein blackleg resistance has been conferred to said progeny) ( page 893, col 2, para 2).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Larkan in view of NCBI accession XM_018589549.1 and the peptide derived thereof, XP_018445051.1, and NCBI sequence accession AAL61927.1 as applied to claims 1-6, and 8 above, and further in view of Jacqueth (U.S. Patent Application Publication No. 2021/0040569A1, assigned to Pioneer Hi Bred International Inc titled 'Methods of identifying, selecting, and producing disease resistant crops', published 2/11/2021) and Menz (Menz J, Modrzejewski D, Hartung F, Wilhelm R, Sprink T. Genome Edited Crops Touch the Market: A View on the Global Development and Regulatory Environment. Front Plant Sci. 2020 Oct 9;11:586027. doi: 10.3389/fpls.2020.586027. PMID: 33163013; PMCID: PMC7581933, published 9/10/2020).
Claim 7 depends from claim 6 with the further limitation that homologous recombination or a genome editing technology is used.
Larkan and NCBI accessions XM_018589549.1, XP_018445051.1, and AAL61927.1 do not explicitly teach homologous recombination or a genome editing technology.
Jacqueth, is in the same field of endeavor to produce disease resistant crops and aims to solve a reasonable pertinent problem as Applicant: introducing resistance genes into plants at a targeted location. Jacqueth teaches that “Disease affecting canola plants include, but are not limited …black leg;” (column 29, lines 17-35). Jacqueth teaches that “polynucleotide compositions can be introduced into the genome of a plant using genome editing technologies…. For example, the identified polynucleotides can be introduced into a desired location in the genome of a plant through the use of double-stranded break technologies such as TALENs, meganucleases, zinc finger nucleases, CRISPR-Cas, and the like” (column 6, lines 23-33). Jacqueth teaches homologous recombination by replacing a native allele with a resistant allele using a gRNA/Cas9 Site directed nuclease system where resistant alleles included, but were not limited to, wall associated kinases as in the present application (begins on column 33, line 24, example 6).
Menz teaches that resistant genome-edited (GE) plants are being differentially regulated, with many, though not all countries creating specific rules or exemptions for GE crops that do not introduce transgenes that exclude them from GMO legislation (page 13, conclusion). This distinction allows some GE crops, especially those without foreign DNA (transgenes), to reach the market faster.
Therefore, it would have been obvious to one of ordinary skill in the art before the filing of the claimed invention to combine and modify the teachings of Larkan and NCBI accessions XM_018589549.1, XP_018445051.1, and AAL61927.1 with the method of homologous recombination taught by Jacqueth to genetically modify a native allele which may be an “an allele which does not confer blackleg resistance” (Instant application specification, page 21, lines 1-3) by introduce the open reading frame of a gene that confers enhanced resistance to blackleg using homologous recombination or a genome editing technology. There is a reasonable expectation of success of combining Larkan and NCBI accessions XM_018589549.1, XP_018445051.1, and AAL61927.1 with the method of homologous recombination taught by Jacqueth because Homologous recombination or homology direct repair is well known in the art. Homologous recombination and general genome editing techniques have been widely understood and used in genetic engineering field for decades, long before recent advancements like CRISPR made them more efficient. A person of ordinary skill in the art would be familiar with these methods. Additionally, Jacqueth was already teaching that their method was sell-suited for providing plant resistance to various diseases including but not limited to diseases affecting canola. A person having ordinary skill in the art would have been motivated to combine and modify the above teachings to achieve the claimed invention as Menz teaches that “in November 2018, the delegations of several countries signed the international statement on agricultural applications of precision biotechnology in the WTO Committee on Sanitary and Phytosanitary Measures (CSPM)… agree[ing] to engage for the exploration of science based opportunities for regulatory frameworks and the avoidance of trade barriers for products derived from genome editing [and]… affirming that cultivars derived from genome editing should be regulated similar to conventional cultivars due to their high similarity” which created a perceivably lucrative market opportunity (page 13, WTO: Committee on Sanitary and Phytosanitary Measures).
Claim(s) 15, 19-21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Larkan in view of NCBI accession XM_018589549.1 and the peptide derived thereof, XP_018445051.1, and NCBI sequence accession AAL61927.1 as applied to claims 1-6 and 8 above, and further in view of Wang (Wang et al. "Constitutive expression of pea defense gene DRR206 confers resistance to blackleg (Leptosphaeria maculans) disease in transgenic canola (Brassica napus)." Molecular plant-microbe interactions 12.5 (1999): 410-418., Published 01/26/1999).
Regarding claim 15, Larkan and NCBI accessions XM_018589549.1, XP_018445051.1, and AAL61927.1 teach a polynucleotide comprising a nucleic acid sequence which is at least 80% identical to the sequence of SEQ ID NO: 42 or encodes an amino acid sequence which is at least 80% identical to the sequence of SEQ ID NO: 43 and is capable of conferring blackleg resistance.
But Larkan, and NCBI accessions XM_018589549.1, XP_018445051.1, and AAL61927.1 do not explicitly teach that said polynucleotide is operably linked to a heterologous promoter.
Wang, with the analogous goal of ascertaining blackleg disease resistance in a Brassicaceae plant, teaches “that constitutive expression of pea DRR206 [a known antifungal defense gene] can confer substantial resistance to blackleg, caused by L. maculans, in transgenic B. napus” (Abstract; page 411, para 1). Wang’s constitutive expression of the blackleg resistance gene is by the cauliflower mosaic virus (CaMV) 35S promoter which is not native to the DRR230 gene (i.e., said polynucleotide capable of conferring blackleg resistance to a plant is operably linked to a heterologous promoter). Additionally, Wang states that “disease resistance is correlated with strong expression of [blackleg resistance gene]” (page 412, Disease resistance is correlated with strong expression of pea DRR206 and defensin).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing of the claimed invention to combine and modify the teachings of Larkan, and NCBI accessions XM_018589549.1, XP_018445051.1, and AAL61927.1 with Wang’s use of a heterologous promoter to substitute a heterologous promoter like CaMV 35S for the native promoter arriving at the instant invention of claim 15. The motivation to do this would come from Wang’s assertion that “disease resistance is correlated with strong expression of [blackleg resistance gene]” (page 412, Disease resistance is correlated with strong expression of pea DRR206 and defensin) and that CaMV 35S promoter is a strong constitutive promoter well known in the art.
Regarding claim 19, Wang teaches that the blackleg resistance gene DRR230 was “cloned into T-DNA–based binary vector pBI121 downstream from the constitutive CaMV 35S promoter, replacing the β-glucuronidase (GUS) gene” (page 411, Results, para 1). The resulting construct contained blackleg resistance gene DRR230 operably linked to a CaMV 35S promoter (i.e., a vector or gene construct comprising said polynucleotide, capable of conferring blackleg resistance to a plant, operably linked to a heterologous promoter).
Regarding claim 20, Wang teaches “35S-defense gene plasmid constructs were transfected into A. tumefaciens MP90 by the freeze-thaw method”(page 415, Materials and methods, para 1). The vector transfected A. tumefaciens and T1 and T2 transgenic plants contained or comprised blackleg resistance gene DRR230 operably linked to a CaMV 35S promoter (i.e., host cells comprising said polynucleotide, capable of conferring blackleg resistance to a plant, operably linked to a heterologous promoter).
Regarding claim 21, Wang’s T1 and T2 transgenic plants contained or comprised blackleg resistance gene DRR230 operably linked to a CaMV 35S promoter (i.e., plants comprising said polynucleotide, capable of conferring blackleg resistance to a plant, operably linked to a heterologous promoter).
Regarding claim 23, Wang teaches that “the expression of the DRR206 protein was verified by immunoblot” (page 413, col 2; fig 3). The blackleg resistance associated “proteins from Brassica napus transgenic lineGN3-4#22 T1 and T2 plants” read on a polypeptide encoded by the polynucleotide, capable of conferring blackleg resistance to a plant, operably linked to a heterologous promoter. Still, without explicit disclosure of the final polypeptide, a person skilled in the art would inevitably obtain the claimed polypeptide by practicing prior art references’ teachings if the references contain all the necessary elements as Larkan, and NCBI accessions XM_018589549.1, XP_018445051.1, and AAL61927.1 in view of Wang do.
Conclusion
No claims allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YVETTE B TAMUKONG whose telephone number is (571)272-1040. The examiner can normally be reached M-Th 8-5 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, Bratislav Stankovic can be reached at (571) 270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YVETTE BIH TAMUKONG/ Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/ Supervisory Patent Examiner, Art Units 1661 & 1662