BDETAILED 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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1, 3-13 and 36-38 in the reply filed on February 12, 2026 is acknowledged. This Restriction/Election requirement is made FINAL.
Claims 1, 3-14, 16-19, 21-22, 24-31 and 33-38 are currently pending. Claims 14, 16-19, 21, 22, 24-31 and 33-35 are withdrawn from consideration for being directed to non-elected inventions. Claims 1, 3-13 and 36-38 are examined on their merit herein. Claims 1, 3-9, 11-13 and 36-38 are rejected.
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, 3-9, 11-13 and 36-38 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 pre-AIA 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 are broadly drawn to Spinacia oleracea plants, seeds, and plant parts comprising a recombinant chromosomal segment from Spinacia tetrandra on chromosome 3, wherein the recombinant chromosomal segment comprise an allele conferring broad-spectrum resistance to Peronospora effuse relative to a plant lacking the recombinant chromosomal segment.
Claims 1 and the dependent claims 4-9, 11-13, and 36-38 encompass a broad genus of recombinant chromosomal segments derived from S. tetrandra chromosome 3, wherein the segment comprised an allele conferring broad-spectrum resistance to Peronospora effuse, without defining the minimal chromosomal interval required for the trait, despite the known genetic diversity of S. tetrandra and the well-established variability of Peronospora effuse, including its numerous races and corresponding differences in resistance specificity. Thus, resistance to P. effuse is not a single uniform trait but represents a spectrum of race-specific interactions.
Claim 3 encompasses recombinant chromosomal segments comprising any one marker selected from M2-M8, regardless of the size of the recombinant segment, recombination breakpoints, or the structural relationship of the marker to the resistance allele. Although the segment is defined by the presentence of such markers, the claimed segment may be derived from any Spinacia tetrandra line or accession, each of which may exhibit distinct genetic backgrounds and resistance characteristics. Accordingly, the claim still encompasses a broad and heterogeneous genus of recombinant chromosomal segments despite recitation of the markers.
In the broadest sense, claim 1 encompasses any recombinant chromosomal segment derived from Spinacia tetrandra chromosome 3 that contains the resistance allele, regardless of the size of the segment, the recombination breakpoints, or the extent of donor chromatin retained in the Spinacia oleracea genome.
The Specification describes a particular donor-derived resistance-associated haplotype/introgression from S. tetrandra, identified in material derived from accession GB1860, and associated with markers M1-M9 (paragraph 0023, 0027, 0118-0120). Example 2 states that the novel resistance allele was found within a region located on chromosome 3 between 395,121 bp and 1,774,344 bp of the public S. oleracea reference genome V1 (paragraph 0118). Table 1 provides SNP markers information of M1-M9 (paragraph 0120).
However, Specification does not describe the actual resistance-conferring genetic element within this interval. More importantly, the Specification has not described the minimal chromosomal segment required for the recited resistance phenotype. In addition, the Specification does not provide any description or evidence that this specific resistance can be derived from any other Spinacia terandra line or accession, despite the claims encompassing segments from any such source. Thus, the disclosure fails to establish that the recited resistance phenotype is consistently associated wit the claimed chromosomal segments across the full scope of S. tetrandra genetic diversity.
Firstly, specification has not provided a definitive description of the structural identity of the resistance-conferring allele or gene within the disclosed chromosome 3 interval. Although the Specification associated resistance with the donor-derived chromosome segment and linked markers M1-M9 as useful for tracking the introgression in marker-assisted selection. However, the presence of linked marker is not itself a description of the causative allele or of the full structure of the claimed recombinant segment. It is well established in plant genetics that linked markers are surrogate indicators and do not themselves necessary define the causative locus. Pajerowska-Mukhtar (Karolina Pajerowska-Mukhtar et. al., Genetics (2009) 181: pp1115–1127) (page 1117, left column paragraph 2) points out, “The most valuable diagnostic DNA-based markers are those derived from polymorphisms in the genes causal for a trait of interest, as such markers are in complete linkage disequilibrium with the quantitative trait alleles”. Furthermore, the presence of a single marker selected from markers M2-M8 does not uniquely define the resistance-conferring chromosomal segment. Because recombination can occur between the marker and the causative allele, a chromosome segment containing the marker may or may not contain the resistance-conferring genetic element. Thus, the presence of any one of markers M2-M8 does not provide sufficient structural definition of the claimed chromosome segment.
Therefore, the Specification does not identify: (1) the specific gene responsible for the resistance phenotype, (2) the nucleotide sequence of the causative allele, (3) the polymorphism responsible for the trait, or (4) any other structural feature that distinguished the resistance-conferring locus from other genetic elements, located within the same chromosome region. Thus, the Specification does not describe the structural identity of the genetic element responsible for the claimed resistance phenotype. Without such structural information, the Specification does not establish a structure-function correlation sufficient to identify which chromosome segments within the claimed genus-possess the claimed resistance phenotype.
Secondly, the Specification has not described which portion of the disclosed chromosome 3 interval is necessary and sufficient for the recited resistance phenotype.
In the art of plant genetics and crop breeding, a definitive description of a genetic locus can be achieved by describing the distance between the locus and a known marker, or by identifying markers flanking the locus Amiteye (Samuel Amiteye, Heliyon 7 (2021) e08093, pp 1-20) (page 2, left column last paragraph) .
Although the Specification describes markers M1-M9 and a general chromosome interval between approximately 395 kb and 1.77 Mb. The Specification does not discloses: (1) which portion of this interval must be retained to maintain the resistance phenotype, (2) which recombination breakpoints are permissible, or (3) which marker define the minimal resistance-conferring chromosomal segment.
In the broadest sense, any chromosomal segment derived from Spinacia tetrandra chromosome 3 that contains the resistance allele would fall within the scope of claim 1. Because the Specification does not identify the minimal interval or define flanking markers that delimit the resistance locus, the claims encompass numerous recombinant chromosome 3 segments having different sizes, different recombination breakpoints, and different genetic contents.
Therefore, although the specification escribes a particular donor-derived chromosome segment associated with resistance, the Specification does not describe the structural features required to distinguish resistance-conferring chromosome segments from other chromosome 3 segments derived from Spinacia tetrandra.
As known in the art, DNA markers are commonly used in plant breeding for marker-assisted selection, where the presence or absence of a marker served as a proxy for a linked trait gene. However, in order for a marker to function as a reliable proxy for a trait locus, the structural relationship between the marker and the trait gene must be defined, for example through identification of flanking markers or genetic distance.
In the present case, the Specification does not describe the distance between the resistance-conferring genetic element and the markers, nor does it disclose which marker flank the resistance locus or define the minimal effective interval.
Accordingly, the Specification does not adequately describe the structural features that must be retained in members of the claimed genus in order to maintain the resistance phenotype.
Therefore, the Specification has not adequately described the structural features required to establish a structure-function relationship between the chromosome segment and the recited resistance phenotype.
Theus, the Specification has failed the first test of Eli Lilly, i.e., describing the identifying characteristic of the claimed subject matter sufficient to distinguish it from other genetic elements located on the same chromosome.
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.
Initially, the size of the claimed scope is considered. In the instant case, the species at issue are recombinant chromosomal segments derived from Spinacia tetrandra chromosome 3. Such chromosomal segments may vary widely in size, recombination breakpoints, retained donor DNA, gene content, and regulatory sequences. For example, The Arabidopsis Genome Initiative (The Arabidopsis Genome Initiative, Nature (2000) 408 pp796-815) discloses 1 Mb genome segment encodes about 220 genes in average in Arabidopsis (calculated from Abstract, page 796). Because a chromosome region contains numerous genes, regulatory elements, polymorphisms, and structural variants, an essentially unlimited number of recombinant chromosome segments may exist that fall within the scope of the claims.
Moreover, the claim scope encompasses recombinant chromosomal segments derived from any S. tetrandra line or accession, each of which may harbor district genomic sequences and structural variations. As recognized in the prior art (Gehendra Bhattarai et. al., Frontiers in Plant Science (2022), DOI 10.3389/fpls.2022.1012923, pp1-16), resistance to Peronospora effuse is variable and race-specific, and may be conferred by different loci or alleles in different genetic background (page 2 left column paragraph 2-3). Accordingly, different S. tetranda accessions may possess structurally and genetically distinct chromosomal segments conferring different spectra of resistance.
Given the virtually infinite structural variability associated with these embodiments, the claims read on an extremely broad and highly diverse genus of chromosome segments that are required to have the specific function of conferring resistance to Peronospora effuse.
In contrast, the Specification describes only a limited donor-associated chromosome segment identified through marker linkage analysis, and does not disclose structurally distinct chromosome segments spanning the breadth of the claimed genus.
Applicant has therefore not provided a representative number of species commensurate with the breadth of the claimed genus. 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. 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.
Accordingly, it is not clear that Applicant was in possession of the claimed genus at the time this application was filed.
Enablement
Claims 1, 3-9, 11-13 and 36-38 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.
As discussed above in the Written Description section, the claims are broadly drawn to Spinacia oleracea plants, seeds, and plant parts comprising a recombinant chromosomal segment from Spinacia tetrandra on chromosome 3, wherein the recombinant chromosomal segment comprise an allele conferring broad-spectrum resistance to Peronospora effuse relative to a plant lacking the recombinant chromosomal segment.
The issue for enablement is not whether the Specification enables a single resistant introgression example, but whether the Specification enables the full scope of the claimed genus without undue experimentation. The scope of the claimed invention is therefore extremely broad.
Claims 1 and the dependent claims 8-9, 11-13, and 36-38 encompass a broad genus of recombinant chromosomal segments derived from S. tetrandra chromosome 3, wherein the segment comprised an allele conferring broad-spectrum resistance to Peronospora effuse, without defining the minimal chromosomal interval required for the trait.
Claim 3 encompasses recombinant chromosomal segments comprising any one marker selected from M2-M8, regardless of the size of the recombinant segment, recombination breakpoints, or the structural relationship of the marker to the resistance allele.
Claims 4-7 further broaden the scope by requiring resistance to multiple races and isolates of Peronospora effuse, thereby expanding the functional breadth of the claimed genus.
However, the specification does not provide the enabling guidance necessary for one of ordinary skill in the art to make and use the full scope of the claimed invention without undue experimentation.
The nature of the invention is a spinach plant distinguished from other spinach plants by the presence of resistance-conferring allele introgressed from S.tetrandra chromosome 3.
To practice the full scope of the claims, one of ordinary skill in the art would need to generate recombinant chromosome 3 introgressions from S. tetrandra into S. oleracea; identify which recombinant segments contain the resistance allele; and verify that the resulting plants exhibit the claimed broad-spectrum resistance phenotype.
However, the specification does not identify the causative resistance gene or allele, nor does it define the minimal chromosomal segment required for the resistance phenotype. Instead, the specification only discloses that the resistance allele lies within a relatively large genomic interval between marker M1 and M9 (paragraph 0118). This interval is approximately 1.4 M base pairs and contains numerous genes and regulatory elements.
Because the Specification does not identify the causative allele or minimal resistance-conferring segment, one of ordinary skill in the art would not know which recombinant chromosome 3 segments with this interval actually fall within the scope of the claims. Accordingly, a skilled artisan would need to generated and analyze numerous recombinant introgressions to determine which chromosome segments retain the resistance-conferring locus.
Although the Specification discloses markers M1-M9, the claims are not limited to the specific marker-bounded interval described in the Specification. For example, claim 1 does not require the recombinant segment to be flanked by M1 and M9, and Claim 3 requires only that the segment comprise one marker selected from M2-M8. Furthermore, claim is not limited to a particular S. tetrandra line or accession, and thus the markers could be applied to any S. tetrandra line or accession. As a result, claim 3 encompasses a broad range of chromosome 3 segments that may differ substantially in genetic content, sequence composition, structural variation and functional relationship to disease resistance. Accordingly, the claim covers a broad and heterogenous genus of chromosome 3 recombinant segments with respect to both their contents and their function in conferring resistance to Peronospora effuse.
A recombinant chromosomes 3 segment containing any one of these markers may vary widely in genomic length; recombination breakpoints; surrounding donor DNA; and genetic background. The Specification does not teach which of these structural variants are operative. Therefore, a skilled artisan would be required to generate and test numerous recombinant chromosome segments in order to determine which embodiments fall within the scope of the claims.
The Specification itself acknowledges that breading with wild spinach relatives is complex and unpredictable. For example, Wild Spinacia tetrandra accessions are genetically heterogeneous and individual seeds within an accession may have distinct genetic compositions (paragraph 0019, 0117 instant application) and Swarup (Shilpa Swarup et. al., Crop Science (2021) 61, pp839–852) (page 839, Abstract), Brugmans (Bart Willem et. al., WO2015054339A1, 2014-10-08 Application; 2015-04-16 Publication) identifies multiple S. tetrandra accessions (e. g., GB1860 and GB1861) as potential sources of the resistance locus, indicating that resistance is not limited to a single accession and may vary depending on the genetic source (page 5, line 30-31, page 6 line 1-31). Crosses between S. oleracea and S. tetrandra may exhibit reduced fertility and other genetic complications (paragraph 0020 instant application). Introgression of genomic regions from non-cultivated germplasm into elites’ cultivars can involve linkage drag and other deleterious effects (paragraph 0035) and Teressa (Temesgen Teressa et. al., Advances in Crop Science and Technology (2024) 12: 665, Vol 12(2)) (page 2, paragraph 1-2). Suppressed recombination in introgression regions is also know to occur in plant breeding programs (paragraph 0037) and Wong (Edgar L. Y. Wong et. al., Frontiers in Plant Science (2023) Volume 14 pp1-7) (page 3, right column, paragraph 1).
These factors demonstrate that introgression disease-resistance loci from wild relatives is not a predictable process.
Consequently, identifying recombinant chromosome segments that both retain the resistance phenotype and satisfy the full breadth of the claims would require extensive empirical experimentation.
The Specification describes the markers primarily as tools for marker-assisted selection (MAS) during breeding. However, the presence of a single linked marker does not necessarily guarantee the presence of the causative allele. It is well established in plant genetic that linked markers may segregate from causative genes due to recombination events, Slatkin (Montgomery Slatkin, Nature Reviews Genetics (2008) 9(6): 477–485) (page1, paragraph 2).
Therefore, a recombinant segment containing a marker such as M2, M3, M4, M5, M6, M7, and M8 may or may not contain the resistance allele. Because claim 3 requires only presence of one such marker, the claim encompasses many embodiment that may not actually confer the claimed resistance phenotype.
The Specification does not provide sufficient guidance for distinguishing operative embodiments from inoperative embodiments across the full claim scope.
To practice the full scope of the claims, one of ordinary skill in the art would need to conduct extensive experimentation, including: generating numerous recombinant chromosome 3 introgression; genotyping plants across the chromosome 3 region; determining recombination breakpoints; phenotyping plants for resistance against multiple Peronospora effuse races and isolates; and correlating genotype with phenotype. Such experimentation would constitute a substantial research program, rather than routine verification.
Although the Specification may enable the specific donor-derived resistance introgression described in the examples, it does not enable the full scope of the claimed genus of recombinant chromosome 3 segments from S. tetrandra conferring broad-spectrum resistance to Peronospora effuse. Because the Specification does not identify the causative allele, does not defined the minimal effective interval, and does not provide guidance commensurate with the breath of the claims, practicing the full scope of the claims would require undue experimentations.
Enablement Regarding Biological Deposit
Claim 10 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.
The invention appears to employ the seed of novel plants. Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, the requirements of 35 U.S.C. 112 may be satisfied by a deposit thereof. The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
If the deposit of the seed is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating the seed have been deposited under the Budapest Treaty and that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent would satisfy the deposit requirement made herein.
In the instant case, Applicant has stated that a deposit of at least 625 seeds of spinach line MSA-S021-1336M was made with the Provasoli-Guillard National Center for Marine Algae and Microbiota (NCMA) and that the deposit has been accepted under the Budapest Treaty (paragraph 0108).
37 CFR 1.808 requires that a statement be made that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent. It is not clear from the specification if all restrictions upon availability to the public will be irrevocably removed upon granting of the patent or if all restrictions upon availability to the public will be merely removed upon granting of the patent. Thus, this rejection is made.
Since the deposit of these seeds was made and accepted under the terms of the Budapest Treaty (paragraph 0108), an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the seeds will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. Merely amending the specification is not sufficient.
Although the rules do not specify a specific number of seeds to be deposited to meet the requirements of these rules, so long as the number of seeds deposited complies with the requirements of the Budapest Treaty International Depositary Authority (IDA) where the deposit is made, the USPTO would consider such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809. Note that the American Type Culture Collection (ATCC), a Budapest IDA, requires a minimum deposit of 625 seeds; other IDAs may have different minimum requirements. Accordingly, any depositor should confirm that the number submitted to a specific IDA complies with that IDA's requirements for seed deposits.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become unviable.
Applicant has indicated that Applicant intends to perfect the deposit in accordance with 37 CFR 1.801-1.809. However, since 37 CFR 1.801-1.809 addresses procedural matters concerning biological deposits and not substantive issues, both Budapest Treaty and non-Budapest Treaty deposits must provide assurances that:
(1) Access to deposited material will be available, during pendency of a patent application making reference to it, to anyone determined by the Director to be entitled to access under 37 CFR 1.14 and 35U.S.C.122 (see In re Lundak, 227 USPQ 90, 94-95 (Fed. Cir. 1985) (citing 35 U.S.C. 114)); and
(2) Subject to paragraph (b) of 37 CFR 1.808, all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.
According, Applicant needs to provide a signed statement providing the assurance above as required to overcome this rejection. Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Claim Rejections - 35 USC § 102
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, 8-13, and 36-38 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brugmans (WO2015054339A1).
Claim 1 recites a Spinacia oleracea plant comprising a recombinant chromosomal segment from Spinacia tetrandra on chromosome 3, wherein said recombinant chromosomal segment comprises an allele that confers broad-spectrum resistance to Peronospora effusa relative to a plant lacking said recombinant chromosomal segment.
Brugmans discloses Spinacia oleracea spinach plant comprising in its genome an introgressed locus from Spinacia tetrandra that confers broad-spectrum resistance to Peronospora farinose f.sp. spinaciae (Claim 1).
Brugmans further discloses that the introgressed locus is defined as flanked in the Spinacia tetrandra genome by loci corresponding to SEQ ID NO:1 and SEQ ID NO:2 (claim 7). Sequence alignment evidence shows that SEQ ID NO:2 aligns to Spinacia oleracea chromosome 3 at positions 149032782-149032662 with 98% identity, and SEQ ID NO: 1 aligns to Spinacia oleracea chromosome 3 at positions 144348307-144348417 with 90% identity. Thus , the flanking sequences disclosed in Brugmans’ map to chromosomes 3, evidencing that the prior-art introgressed locus from S. terandra is located on chromosome 3.
Brugmans also teaches that the introgressed S. terandra locus confers broad-spectrum resistance to multiple races of the spinach downy mildew pathogen, including resistance to races 7, 10, 11, 12, 13, and 14, and in some embodiments to races 1-14 and UA4721 (page 2 line 4-8, Example 1, claim 2-3). The presently claimed pathogen, Peronospora effusa, reads on the pathogen disclosed in Brugmans, Peronospora farinose f. sp. Spinaciae, because the instant specification states that Peronospora effusa is the pathogen causing spinach downy mildew and was formerly known as P. farinose f. sp. spinaciae (instant specification paragraph 0017).
The instant specification further confirms that Brugmans previously identified GB1860 as a source of a downy mildew resistance allele and acknowledges that the prior-art introgressed region described in Brugmans spans a region on chromosome 3 (instant specification paragraph 0121).
Thus, Brugmans discloses each and every limitation of claim 1, including a Spinacia oleracea plant comprising a recombinant chromosomal segment from Spinacia tetrandra on chromosome 3, wherein the recombinant chromosomal segment comprises an allele conferring broad-spectrum resistance to Peronospora effusa. Because Brugmans expressly discloses all elements of the claimed invention arranged as recited in claim 1, claim 1 is anticipated by Brugmans.
Claim 8 recites the Spinacia oleracea plant of claim 1, defined as an inbred plant or a hybrid plant.
Brugmans discloses the spinach plant or progeny thereof obtainable by introgressing a locus from S. tetrandra defined as an inbred or hybrid plant (claim 31, 34, and 35).
Claim 9 recites the Spinacia oleracea plant of claim 1, defined as an agronomically elite plant.
Brugmans discloses the spinach plant or progeny thereof obtainable by introgressing a locus from S. tetrandra defined as an agronomically elite plant (claim 31 and 36).
Claim 11 recites a seed that produces the plant of claim 1, wherein the seed comprises the recombinant chromosomal segment.
Brugmans discloses a seed that produces the plant of spinach plant or progeny thereof obtainable by introgressing a locus from S. tetrandra (claim 31 and 39).
Claim 12 recites a plant part of the plant of claim 1, wherein said plant part comprises the recombinant chromosomal segment.
Brugmans discloses a plant part of spinach plant or progeny thereof obtainable by introgressing a locus from S. tetrandra (claim 31 and 10).
Claim 13 recites the plant part of claim 12, wherein the plant part is selected from the group consisting of: an embryo, a meristem, a cotyledon, pollen, a leaf, an anther, a root, a pistil, a flower, and a cell.
Brugmans discloses wherein the plant part is selected from the group consisting of an embryo, meristem, cotyledon, pollen, leaf, anther, root, pistil, flower, cell, and stalk (claim 11).
Claim 36 recites a cell according to claim 13.
Brugmans discloses wherein the plant part is cell (claim 11)
Claim 37 recites a tissue culture comprising the cell of claim 13.
Brugmans discloses the term "plant" includes plant cells, plant protoplasts, plant cells of tissue culture from which spinach plants can be regenerated (page 16, line 21-24)
Claim 38 recites a food product comprising the harvested leaves of the Spinacia oleracea plant of claim 1.
Brugmans discloses a food product comprising the harvested leaves of spinach plant or progeny thereof obtainable by introgressing a locus from S. tetrandra (claim 31 and 42).
Because Brugmans discloses the resistant Spinacia oleracea plant of claim 1, and the additional limitations of claim 8-13, and 36-38 are directed to conventional breeding forms, plant parts, cells, tissue culture, and food products inherently derived from that disclosed plant, Brugmans discloses every limitation of claim 8-13, and 36-38. Accordingly, claims 8-13 and 36-38 are anticipated by Brugmans.
SEQ ID NO: 1 from WO2015054339A1
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990
1461
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SEQ ID NO: 2 from WO2015054339A1
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864
1443
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Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YANXIN SHEN whose telephone number is (571)272-7538. The examiner can normally be reached Monday-Friday.
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/YANXIN SHEN/ Examiner, Art Unit 1663
/WEIHUA FAN/ Primary Examiner, Art Unit 1663