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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-13 & 19) in the reply filed on 4/21/2026 is acknowledged. The traversal is on the ground(s) that all four groups are connected by the unifying special technical feature of a downy mildew resistant RTM-1 gene capable of conferring resistance to multiple downy mildew races (Remarks, page 2, paragraph 9). This is not found persuasive, because the instant specification does not describe or define the RTM-1 gene beyond the features that it confers resistance to multiple downy mildew races, is found in a Spinacia tetrandra line, and is located in the region of chr4_7962907 to chr4_8617232 in the spinach genome.
Laan teaches a locus of resistance to downy mildew in this same region with associated markers found on chromosome 4 in a region encompassing the SNPs of the instant claims (page 8, line 5-page 9, line 7 & table 5). Laan also teaches that a spinach line comprising a copy of the S. tetrandra genotype in this region has resistance to multiple downy mildew race (table 4). Thus, Laan’s resistant spinach plants comprising resistant SNP markers for a downy mildew resistance gene in the region of the RTM-1 gene of the instant claims read on the instantly claimed resistant spinach plants comprising an RTM-1 gene or comprising DNA markers for an RTM-1 gene.
The requirement is still deemed proper and is therefore made FINAL.
Claims 14, 16-18 & 22-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/21/2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Status of Claims
Claims 1-13 & 19 are under examination on the merits.
Claims 14, 16-18 & 22-24 are withdrawn from consideration.
Claim Objections
Claims 1-3 & 8 are objected to because of the following informalities:
Claim 1 (lines 1 & 2), claim 2 (lines 2-3), claim 3 (line 3), and claim 8 (line 2): The species name Spinacia tetrandra should be italicized in all uses.
Claim 1 (line 2): “RTM-1” gene name should be written out in full in independent claims before using an abbreviation.
Appropriate correction is required.
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 1-7, 9-11 & 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) a “downy mildew resistant spinach plant (excluding Spinacia tetrandra)” (Claim 1, line 1). Because it is indefinite whether the material within the parentheses is a required limitation, the claims have been interpreted to encompass Spinacia tetrandra plants.
Wild Spinacia tetandra plants comprising the RTM-1 gene on chromosome 4 and the alleles associated with the RTM-1 locus are known to have existed in the wild and so constitute a natural phenomenon. See Wageningen CGN Germplasm record CGN25466 (accessed 6/12/2026 from https://cgngenis.wur.nl/accessiondetails/CGN25466, line available 6/24/2011).
This judicial exception is not integrated into a practical application because the claims are drawn to the plant or a part of the plant body. Claims 1-7, 9-10 & 19 not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims require nothing more than a gene, or alleles, or genes not patentably distinct from, those found in the wild, naturally occurring Spinacia tetrandra plant. The art is silent as to whether the natural accession CGN25466 has at least one type of downy mildew resistance gene besides RTM-1; however, genes other than RTM-1 conferring resistance to downy mildew are known to exist in the wild and a cross between a plant of CGN25466 genotype and one comprising a different resistance gene would be expected to occur naturally. The progeny of a natural cross such as this would read on the plant of instant claim 11.
Claims 1-7, 9-11 & 19 encompass the natural phenomenon of wild spinach plants. Claims 8 & 12-13, drawn to interspecific hybrids or specific progeny lines, do include additional elements that amount to more than the judicial exception and are not included in this rejection.
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 1-13 & 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is drawn to “a downy mildew resistant spinach plant (excluding Spinacia tetrandra)” (line 1) comprising a downy mildew resistance gene located on chromosome 4 of the S. tetrandra line CGN25466:MGK 01. The text within the parentheses renders claim 1 indefinite, because it is unclear how much S. tetrandra genotype is allowable in a plant that is within the metes and bounds of the claims. Claim 1 encompasses plants with S. tetrandra ancestry, as evidenced by dependent claim 8, drawn to the plant derived from an interspecific hybrid plant of S. tetrandra and a cultivated variety of spinach. It is not clear whether backcrosses or selfed progeny of the hybrid plant, which may have more S. tetrandra features, would be considered S. tetrandra and excluded from the claims. Furthermore, the parentheses mean that it is unclear if the material within the parentheses is a required limitation. Dependent claims 2-13 & 19 are also indefinite.
Claim 6 recites “a SNP specified by chr4_8488603”, “a SNP specified by chr4_8494600” and “a SNP specified by chr4_8510715” in lines 3-5. Claim 7 recites “a SNP specified by chr4_7962907”, “a SNP specified by chr4_8152986”, “a SNP specified by chr4_8190990”, “a SNP specified by chr4_8488603”, “a SNP specified by chr4_8494600”, “a SNP specified by chr4_8510715”, and “a SNP specified by chr4_8617232” in lines 3-9. Because multiple species of spinach are encompassed by the definition in the specification, and even within a species there may be differences in nucleotide positions within a chromosome, it is indefinite whether a SNP recited by the claims represents SNPs in different locations in different varieties. Therefore, the identity of the SNPs recited by the claims is unclear and the scope of the limitation of a plant comprising in at least one allele one of the recited “SNPs” is indefinite.
The specification defines terminology “chrX_Y” to mean the nucleotide base within the spinach plan which corresponds with base Y of chromosome X in the reference genome sequence v1 published in SpinachBase (specification, page 14, lines 9-16). However, if the sequence of the reference spinach genome is necessary to define the claimed invention as required by 35 USC 112, 2nd paragraph, the reference genome constitutes essential material to the claimed invention. Essential material may be incorporated by reference only by way of an incorporation by reference to a U.S. patent or U.S. patent application. Mere reference to material does not convey an intent to incorporate the material by reference. An incorporating statement, comprising the root words “incorporate” and “reference”, clearly identifying the subject matter which is incorporated and where it is to be found is required. In re de Seversky, 474 F.2d 671, 177 USPQ 144 (CCPA 1973). See 37 CFR 1.57(b)(1) and 1.57 (c).
Claim 9 recites “a plant specified in accession number FERM BP-22404” (line 2) and claim 10 recites “a plant specified in accession number FERM BP-22405” (line 2). Claim 12 recites a “downy mildew resistant spinach plant specified in accession number FERM BP-22404” (lines 3-4) and claim 13 recites a “downy mildew resistant spinach plant specified in accession number FERM BP-22405” (lines 2-3). It would be improper to read limitations from the specification into the claims. The claims are not definite as to what plants these accession numbers refer to because they do not include the repository where the plants are accessioned and for which the accession numbers have been assigned.
Claim 12 recites the limitation "the downy mildew resistant spinach plant" in lines 3-4. Claim 13 recites the limitation “the downy mildew resistant spinach plant” in lines 3-4. There is insufficient antecedent basis for this limitation in the claims, because “the downy mildew resistant spinach plant” in lines 3-4 could be a reference to the downy mildew resistant spinach plant that is TNKH-1 or TNKH-2 (in claims 12 & 13, line 3, respectively) or to the downy mildew resistant spinach plant of claim 1.
Improper Dependency
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.
Claim 2 is 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 2 is drawn to the downy mildew resistant spinach plant of claim 1 wherein the RTM-1 gene is a gene that exists in a range from chr4_7962907 to chr4_8617232 on chromosome 4 of line CGN25466:MGK 01. Claim 1 is drawn to a spinach plant having the RTM-1 gene. Claim 2 does not further limit the plant of claim 1, because the RTM-1 gene of claim 1 already, inherently, exists in a range from chr4_7962907 to chr4_8617232 on chromosome 4 of line CGN25466:MGK 01. Claim 2 does not require any additional features to be present in the claimed spinach plant beyond the features recited by claim 1.
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.
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.
A. Claims 1-13 & 19 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.
Claims 1-13 & 19 are drawn to spinach plants or a portion of a plant body having a downy mildew resistance RTM-1 gene. Claim 3 further requires that at least one allele of chromosome 4 contains a fragment that includes a range from chr4_8488603 to chr4_8510715 on chromosome 4 of line CGN25466:MGK 01. Claim 4 further requires in at least one allele of chromosome 4 one of three SNPs. Claim 7 further requires in at least one allele of chromosome 4 one of 7 SNPs.
Claims 9 and 10 require that the plant have downy mildew resistance derived from a plant of accession number FERM BP-22404 or FERM BP-22405 respectively; since the lines FERM BP-22404 (TNKH-1) and FERM BP-22405 (TNKH-2) both comprise more than one downy mildew resistance locus (instant specification page 36, lines 16-22), these claims encompass plants wherein RTM-1 gene is derived from another source than lines FERM BP-22404 (TNKH-1) and FERM BP-22405 (TNKH-2).
The limitation “a fragment that includes a range from chr4_8488603 to chr4_8510715 on chromosome 4” (claim 3) encompasses fragments of any length within the range from chr4_8488603 to chr4_8510715 on chromosome 4.
The specification defines spinach as a plant belonging to the genus Spinacia (page 12, lines 20-21).
Thus, claims 1-13 & 19 are drawn to a plant or portion of a plant body of any spinach species except Spinacia tetrandra and broadly require an “RTM-1” gene that is found in line CGN25466:MGK 01 in a region from chr4_8488603 to chr4_8510715 on chromosome 4 that encompasses 654,325 bases.
The instant specification describes RTM-1 as a downy mildew resistance gene located on chromosome 4 of Spinacia tetrandra line CGN25466:MGK 01, which is located in the range from chr4_7962907 to chr4_8617232 according to the location in the spinach v1 reference genome of Spinach Base (page 15, lines 15-21). The specification describes that RTM-1 imparts resistance to multiple downy mildew races (page 15, line 23-page 16 line 1). The instant specification does not describe the structure of the individual gene or genes responsible for the resistance phenotype.
The specification provides 13 example SNPs in the region of the chromosome where RTM-1 is located (table 1). The specification describes primer sets to distinguish these 13 markers (tables 8 & 9). The specification describes lines of different genotypes at these 13 markers to conclude that the SNPs have a strong correlation with the phenotype and the resistance gene is located within the range of chr4_7962907 to chr4_8617232 (page 50, lines 4-12, table 10).
The instant specification describe a wild Spinacia tetrandra line CGN25466:MGK 01 from CGN of Holland with resistance, and also describe Spinacia tetrandra line CGN25474:MGK 18 as exhibiting susceptibility to Pfs6 (page 32, lines 4-11). The instant specification describes crossing and backcrossing CGN25466:MGK 01 with an advanced parent line of unspecified provenance to obtain BC1F1S5 lines with resistance to Pfs10 and UA1014 (page 31, line 16-page 34, line 7).
The instant specification describes three downy mildew resistant spinach lines comprising RTM-1 that are not Spinacia tetrandra: TNKH-1, which is homozygous for RPF3, TNKH-2, which is homozygous for RPF4, and TNKH-3, which is segregating for RPF3 and RPF4 (page 34, lines 9-14). According to the specification, seeds of TNKH-1 and TNKH-2 have been deposited in the National Institute of Technology and Evaluation International Patent Organism Depositary (page 35, lines 1-7).
Resistant spinach plants of backgrounds other than Spinacia tetrandra and Spinacia oleracea have not been described in the instant specification. The genotype at each of the markers of other tested S. oleracea lines are not provided in the specification.
“RTM-1” resistance genes to downy mildew in spinach are not described in the art. However, resistance loci to downy mildew located on chromosome 4 are known in the art. Boshoven et al US 2023/0404006A1 (published 12/21/2023 but with a priority date of 11/24/2020 before the instant application; hereafter Boshoven) describes spinach plants resistant to Peronospora farinosa (downy mildew) comprising a genomic fragment of Spinacia tetrandra located on chromosome 4 between positions 8255074 and 8620598 (abstract, paragraphs [0061-0069], table 3). Boshoven describes SNPs for detection of the resistance locus (table 4). Laan et al US 2022/0220498 A1 (published 7/14/2022, with a priority date of 5/29/2019, the US filing of WO 2020/239215) teaches a spinach population derived from S. oleracea and S. tetrandra crosses with resistance to downy mildew (table 2), and the resistance co-segregates with a region from S. tetrandra located on chromosome 4 between 8.0 and 8.9Mb (paragraphs [0048-0050]). Groenendijk et al US 2025/0019717 A1 (published 1/16/2025, with a priority filing date of 8/5/2022, after that of the instant application) describes an RPS2-like resistance gene SOV19044450 in Spinacia oleracea on chromosome 4 that provides resistance to downy mildew (paragraphs [0283-0285]).
Thus, spinach resistance loci to downy mildew found on chromosome 4 are known in the art, including resistance loci introgressed from S. tetrandra and overlapping the region described by the instant invention.
However, the region encompassed by the instant claims comprises 654,325 bases. The instant specification has not described the structural features of this region responsible for the resistance phenotype. The deposited lines TNKH-1 and TNKH-2 and the mapping lines of the instant specification obtained from the single S. tetrandra line CGN25466:MGK 01 do not constitute a representative sample of spinach diversity over the full scope of the RTM-1 gene and the region in which it is located or of plants comprising a fragment of the recited region. The 13 provided SNP markers do not describe spinach diversity over the full scope of the region where the RTM-1 gene is located. One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus of spinach plants comprising an RTM-1 gene found in line CGN25466:MGK 01 in view of the disclosed species.
Hence, Applicant has not, in fact, described a downy mildew resistance RTM-1 gene on chromosome 4 of line CGN25466:MGK 01 and spinach plants comprising said gene over the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention. Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Scope of Enablement
A. Claims 1-13 & 19 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 downy mildew resistant spinach plant comprising the region from chr4_7962907 to chr4_8617232 on chromosome 4 from Spinacia tetrandra line CGN25466: MGK 01, does not reasonably provide enablement for any spinach plant having a downy mildew resistance RTM-1 gene located on chromosome 4 of line CGN25466: MGK 01. 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.
The claims require a spinach plant or portion of a plant body comprising an RTM-1 downy mildew resistance gene, which is located on chromosome 4 of line CGN25466: MGK 01.
The instant specification teaches RTM-1 to be a downy mildew resistance gene located on chromosome 4 of Spinacia tetrandra line CGN25466:MGK 01 located in the range from chr4_7962907 to chr4_8617232 according to the location in the spinach v1 reference genome of Spinach Base (page 15, lines 15-21). The specification describes that RTM-1 imparts resistance to multiple downy mildew races (page 15, line 23-page 16 line 1). The instant specification does not teach the structure of the individual gene or genes responsible for the resistance phenotype.
The specification provides 13 example SNPs in the region of the chromosome where RTM-1 is located (table 1). The specification teaches primer sets to distinguish these 13 markers (tables 8 & 9). The specification provides examples of mapping lines of different genotypes at these 13 markers to conclude that the SNPs have a strong correlation with the phenotype and the resistance gene is located within the range of chr4_7962907 to chr4_8617232 (page 50, lines 4-12, table 10).
The instant specification teaches a wild Spinacia tetrandra line CGN25466:MGK 01 from CGN of Holland with resistance, and also teaches a Spinacia tetrandra line CGN25474:MGK 18 exhibiting susceptibility to Pfs6 (page 32, lines 4-11). The instant specification does not teach how these two S. tetrandra lines differ at the 13 SNPs associated with resistance. The instant specification teaches crossing and backcrossing CGN25466:MGK 01 with an advanced parent line of unspecified provenance to obtain BC1F1S5 lines with resistance to Pfs10 and UA1014 (page 31, line 16-page 34, line 7).
The instant specification teaches three downy mildew resistant spinach lines comprising RTM-1 that are not Spinacia tetrandra: TNKH-1, which is homozygous for RPF3, TNKH-2, which is homozygous for RPF4, and TNKH-3, which is segregating for RPF3 and RPF4 (page 34, lines 9-14). According to the specification, seeds of TNKH-1 and TNKH-2 have been deposited in the National Institute of Technology and Evaluation International Patent Organism Depositary (page 35, lines 1-7).
The specification teaches methods of assaying downy mildew resistance by Pfs inoculation (page 30, line 1-14).
Resistant spinach plants of backgrounds other than Spinacia tetrandra and Spinacia oleracea have not been described in the instant specification.
“RTM-1” resistance genes to downy mildew in spinach are not taught in the prior art. However, resistance loci to downy mildew located on chromosome 4 are known in the art. Boshoven et al US 2023/0404006A1 (published 12/21/2023 but with a priority date of 11/24/2020 before the instant application; hereafter Boshoven) teaches spinach plants resistant to Peronospora farinosa (downy mildew) comprising a genomic fragment of Spinacia tetrandra located on chromosome 4 between positions 8255074 and 8620598 (abstract, paragraphs [0061-0069], table 3). Boshoven teaches SNPs for detection of the resistance locus (table 4). Laan et al US 2022/0220498 A1 (published 7/14/2022, with a priority date of 5/29/2019; the US filing of WO 2020/239215) teaches a spinach population derived from S. oleracea and S. tetrandra crosses with resistance to downy mildew (table 2), and the resistance co-segregates with a region from S. tetrandra located on chromosome 4 between 8.0 and 8.9Mb (paragraphs [0048-0050]). Groenendijk et al US 2025/0019717 A1 (published 1/16/2025, with a priority filing date of 8/5/2022, after that of the instant application) teaches an RPS2-like resistance gene SOV19044450 in Spinacia oleracea on chromosome 4 that provides resistance to downy mildew (paragraphs [0283-0285]).
Although resistance loci for downy mildew are known on chromosome 4 in spinach, the locus for RTM-1 taught by the instant specification encompasses 654,325 bases and no mechanism for the resistance is provided by the specification. Applicant does not teach any plants comprising only one of the thirteen SNP markers associated with the phenotype of downy mildew resistance, as required by claims 6 and 7, that still have downy mildew resistance. Applicant does not teach comprising a fragment that includes a range from chr4_8488603 to chr4_8510715, as required by claim 3, which encompasses a region of 22,112 bases and shorter fragments thereof. Applicant does not teach any plants comprising the RTM-1 gene of line CGN25466:MGK 01 that do not also comprise a large introgression of chromosome 4. One of ordinary skill in the art would be required to generate and assay plants over the full scope of the claimed region and/or SNP markers to determine which spinach plants, comprising which genotypes, are in fact downy mildew resistant. The scope of the required experimentation would be undue.
Thus, while downy mildew resistant spinach plants comprising the region from chr4_7962907 to chr4_8617232 on chromosome 4 from Spinacia tetrandra line CGN25466: MGK 01 are enabled for one of ordinary skill in the art, the instant disclosure does not provide enablement over the full scope of the claimed invention of any downy mildew resistant spinach plant having a downy mildew resistance RTM-1 gene located on chromosome 4 of line CGN25466: MGK 01.
B. Claims 12 & 13 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 progeny which is a descendant obtained by sexual reproduction, does not reasonably provide enablement for all progeny encompassed by the specification’s definition of progeny. 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.
Claims 12 & 13 are drawn to a downy mildew resistant spinach plant comprising a downy mildew resistance RTM-1 gene located on chromosome 4 of line CGN25466:MGK 01, wherein the plant is a plant specified in accession number FERM BP-22404 or FERM BP-22405, a hybrid plant obtained using the resistant plant as a parent, or a progeny of either of these plants.
The instant specification describes a progeny plant as encompassing descendants obtained by crossing as well as somatic cell hybrid plants, and individuals obtained by grafting using the spinach plant as either the stock or the scion and the descendants thereof (specification, page 18, lines 13-22). “Descendants” is described to include individuals obtained by intraspecific or interspecific crossing (page 18, lines 13-22). A descendant of a grafted spinach plant wherein the plant with downy mildew resistance is the stock rather than the scion would not comprise any of the genetic material of the stock spinach plant. Applicant has described no examples of a downy mildew resistant plant descended from the downy mildew resistant rootstock of another spinach plant according to the instant invention. One of ordinary skill in the art would require undue experimentation to figure out how to obtain a downy mildew resistant progeny plant according to the instant claims from a grafted plant, if such a plant is possible. Thus, claims 12-13 are not enabled over the full scope of the claims.
C. Claims 9-10 & 12-13 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.
Claims 9 & 12 require a plant specified in accession number FERM BP-22404, which is referred to as TNKH-1 line in the specification. Claims 10 & 13 require a plant specified in accession number FERM BP-22405, which is referred to as TNKH-2 line in the specification.
Since the plant 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.
The specification does not disclose a repeatable process to obtain the exact same plant in each occurrence and it is not apparent if such a plant is readily available to the public.
If a plant is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. So long as the number of seeds deposited complies with the requirements of the IDA where the deposit is made, the USPTO considers such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809.
It is noted that Applicant describes depositing seeds of these lines in the National Institute of Technology and Evaluation International Patent Organism Depositary with accession dates of 12/25/2020. The deposited microorganisms document included with the PCT materials is provided only in Japanese, and it is not clear that the deposit meets all requirements as described above. Furthermore, there is no affirmative statement in the specification that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
If the deposit of these seeds is made and accepted 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 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.
If the deposit has not been made and accepted under the Budapest Treaty, then in order to certify that the deposit meets the requirements 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; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
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.
Claim(s) 1-7, 9-10 & 19 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Wageningen CGN Germplasm record CGN25466 (accessed 6/12/2026 from https://cgngenis.wur.nl/accessiondetails/CGN25466, line available 6/24/2011) taken with the evidence of the DOI of the CGN Germplasm record CGN25466 (accessed 6/12/2026).
CGN record CGN25466 discloses a Spinacia tetandra accession CGN25466 with collecting number MGK 01 collected in Armenia 6/24/2011 (see origin information). The record provides pictures of the plants at the collecting site. The record provides a DOI for the accession of 10.18730/S9KDF (see other information).
The DOI information for doi:10.18730/S9KDF provides evidence that the DOI for CGN record CGN25466 was created in 2/14/2019, prior to the priority filing date of the instant application.
Claim 1 recites a “downy mildew resistant spinach plant (excluding Spinacia tetrandra)” in line 1. Because it is indefinite whether the material within the parentheses is a required limitation, the claims have been interpreted to encompass Spinacia tetrandra plants.
The downy mildew plant of CGN record CGN25466 collection number MGK 01 would have the downy mildew resistance RTM-1 gene on chromosome 4 of CGN25466:MGK 01, and so the line collected 6/24/2011 anticipates the downy mildew plant of instant claims 1-4 and portion of the plant body of claim 19 and would inherently have resistance to the downy mildew races of Pfs1-Pfs19 (instant claim 5). Such plants would have the CGN25466:MGK 01 alleles required by claims 6-7.
Instant claim 9, which requires a plant having downy mildew resistance derived from a plant specified in accession number FERM BP-22404, and claim 10, which requires a plant having downy mildew resistance derived from a plant specified in accession number FERM BP-22405, are product by process claims. “The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113 (I). The genus of plants of instant claims 9 & 10 comprising downy mildew resistance and comprising resistance derived from FERM BP-22404 or FERM BP-22405 respectively has no other distinguishing characteristics other than downy mildew resistance and a causative locus for resistance that is also found in FERM BP-22404 or FERM BP-22405. All other traits and genotypic markers may differ from FERM BP-22404 or FERM BP-22405. Because the plant of record CGN25466 comprises a downy mildew resistance gene indistinguishable from one found in FERM BP-22404 or FERM BP-22405, it is not patentably distinct from and anticipates the plant of instant claims 9-10.
Claims 1-7, 9-10 and 19 are anticipated by CGN Germplasm record CGN25466.
Claim(s) 1-10, 12-13 & 19 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Laan et al WO 2020/239215 A1 (published 12/3/2020 with a priority date of 5/29/2019, hereafter Laan). Claims 1-10, 12-13 & 19 are drawn to a downy mildew resistant spinach plant or portion of a plant body having a downy mildew resistance RTM-1 gene, which is located on chromosome 4 of the Spinacia tetandra line CGN25466:MGK 01.
Laan discloses crossing Spinacia tetrandra plants of CGN120251 with an agriculturally elite S. oleracea line Blight A to obtain hybrid plants and backcrossed plant lines with mildew resistance (page 5, line 23-page 6, line 7). Laan discloses backcrossed offspring of the cross being crossed with a male line Blight C (page 6, lines 5-7).
Laan discloses that the lines were tested in a disease assay for Peronospora farinosa along with a differential set, and the obtained deposit line NCIMB 43379 was resistant to all Pfs races tested (4, 7, 9-17) (page 6, line 26-page 7, line 7 & table 2). Laan discloses that the disease phenotype is correlated with a marker on chromosome 4 and discloses a region co-segregating with the novel resistance from S. tetrandra located on chromosome 4 between 8.0 and 8.9 Mbp (page 8, line 8-page 9, line 7). Laan discloses SNPs for the detection of the resistance against downy mildew, including a SNP on chromosome 4 at position 8,510,715 of a draft spinach genome, where the allele linked with resistance is a guanine (table 5). Laan discloses a sequence that comprises the SNP at position 8,510,715 of chromosome 4 (Laan SEQ ID NO: 30). Laan discloses downy mildew resistant plants that are heterozygous for a S. tetrandra marker on chromosome 4 (table 3). Laan provides a picture of resistant spinach plants, where leaves are visible (figure 3).
Laan and the instant application do not identify a downy mildew resistance gene beyond its location on Spinacia tetrandra chromosome 4. Thus, although Laan does not disclose Spinacia tetrandra line CGN25466:MGK 01, the downy mildew resistance gene in Spinacia tetrandra line CGN120251 reads on a downy mildew resistance RTM-1 gene located on chromosome 4 of Spinacia tetrandra line CGN25466:MGK 01 (instant claim 1) and wherein the RTM-1 gene is a gene that exists in a range from chr4_7962907 to chr4_8617232 (instant claim 2). Laan’s resistant plants comprising a heterozygous marker on chromosome 4 read on the plants wherein the RTM-1 gene is heterozygous (instant claim 4). Laan’s backcross plants anticipate plants wherein the downy mildew resistant spinach plant is derived from an interspecific hybrid plant of Spinacia tetrandra and a cultivated variety (instant claim 8). Leaves and parts of Laan’s resistant spinach plants anticipate a portion of a plant body of the downy mildew resistant plant (instant claim 19).
Laan’s spinach backcross lines comprising the disclosed sequence (Laan SEQ ID NO: 30) comprising the guanine SNP at position 8,510,715 of chromosome 4 and downy mildew resistance read on a spinach plant wherein at least one allele contains a fragment that includes a range from chr4_8488603 to chr4_8510715 on chromosome 4 of CGN25466:MGK 01 (instant claim 3). They also read on a down mildew resistant spinach plant wherein in at least one allele of chromosome 4 a SNP specified by chr4_8510715 is guanine (instant claims 6 & 7).
Laan is silent with respect to resistance to PFs1, Pfs2, Pfs3, Pfs5, Pfs6, Pfs8 and a race indicated by UA1014; however, Laan’s downy mildew resistant plants were resistant to all downy mildew races tested and so Laan’s plants read on instant claim 5.
Instant claim 9, which requires a plant having downy mildew resistance derived from a plant specified in accession number FERM BP-22404, and claim 10, which requires a plant having downy mildew resistance derived from a plant specified in accession number FERM BP-22405, are product by process claims. “The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113 (I). The genus of plants of instant claims 9 & 10 comprising downy mildew resistance and comprising resistance derived from FERM BP-22404 or FERM BP-22405 respectively has no other distinguishing characteristics other than downy mildew resistance and a causative locus for resistance that is also found in FERM BP-22404 or FERM BP-22405. All other traits and genotypic markers may differ from FERM BP-22404 or FERM BP-22405. Furthermore, since FERM BP-22404 or FERM BP-22405 both comprise an additional locus for downy mildew resistance, the plants of claim 9 and 10 do not even require that the RTM-1 gene be derived from FERM BP-22404 or FERM BP-22405. Laan’s plants, comprising a gene that reads on RTM-1 and downy mildew resistance, thus anticipate a plant of instant claims 9 & 10 because they are indistinguishable from the plants of the instant claims.
Claims 12 and 13 are drawn to a hybrid plant obtained using the downy mildew resistant spinach plant as a parent. While it is indefinite which downy mildew resistant spinach plant is intended as “the” downy mildew resistant spinach plant, Laan’s downy mildew resistant spinach plants which are produced by crossing the backcross line with another line, Blight C, anticipates the hybrid plants of instant claims 12 & 13.
Claims 1-10, 12-13 & 19 are anticipated by or obvious in view of Laan.
Claim(s) 1-5, 8-10, 12-13 & 19 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Boshoven et al US 2023/0404006 A1 (published 12/21/2023, with a priority filing of 11/24/2020; hereafter Boshoven).
Boshoven discloses crossing individual plants of S. tetrandra with S. oleracea line SuscA100168, which has commercially desired characteristics (paragraph [0061]). Spinach plants were backcrossed and assayed for resistance to downy mildew, and one heterozygous plant with a crossover was identified to be resistant to race 15 of downy mildew (paragraphs [0063-0067]). Continued breeding led to a BC3S2 line homozygous for the resistance locus (paragraph [0069]). Boshoven discloses that spinach plants of the obtained line have resistance to downy mildew races 1-17 and UA2020-01E (table 2). Boshoven discloses that the region of the resistance locus co-segregating with resistance is located on chromosome 4 between 8.3 and 8.6 Mbp (paragraph [0074]). Boshoven discloses SNPs for the detection of the resistance against downy mildew located from 8255074-8620598 and provides the sequence of the genetic positions comprising these SNPs (table 4). Boshoven provides a picture of the resistant plants where parts of the plant such as leaves are visible (figure 3).
Boshoven and the instant application do not identify a downy mildew resistance gene beyond its location on Spinacia tetrandra chromosome 4. Thus, although Boshoven is silent with respect to the genotype of Spinacia tetrandra line CGN25466:MGK 01, the downy mildew resistance gene in Spinacia tetrandra disclosed by Boshoven reads on a downy mildew resistance RTM-1 gene located on chromosome 4 of Spinacia tetrandra line CGN25466:MGK 01 (instant claim 1). The region on chromosome 4 disclosed by Boshoven overlaps with the region of instant claim 2, which reads on the RTM-1 gene being a gene that exists in a range from chr4_7962907 to chr4_8617232 (instant claim 2). Boshoven’s resistant plant comprising a heterozygous crossover allele on chromosome 4 read on the plants wherein the RTM-1 gene is heterozygous and the homozygous selfing lines read on plants where the RTM-1 gene is homozygous (instant claim 4). Boshoven’s backcross plants anticipate plants wherein the downy mildew resistant spinach plant is derived from an interspecific hybrid plant of Spinacia tetrandra and a cultivated variety (instant claim 8). Leaves and parts of Boshoven’s resistant spinach plants anticipate a portion of a plant body of the downy mildew resistant plant (instant claim 19).
The instant specification does not define the length of a “fragment”, so an allele containing a fragment that includes a range from chr4_8488603 to chr4_8510715 on chromosome 4 of CGN25466:MGK 01 encompasses alleles comprising any consecutive nucleotides sequences found within this range in CGN25466:MGK 01. Boshoven’s spinach backcross lines comprising the Spinacia tetrandra resistance allele would read on such a plant under the broadest reasonable interpretation of claim 3.
Boshoven is silent with respect to a race indicated by UA1014, however Boshoven’s spinach plants with resistance to Pfs1-17 and all downy mildew races tested reads on instant claim 5.
Instant claim 9, which requires a plant having downy mildew resistance derived from a plant specified in accession number FERM BP-22404, and claim 10, which requires a plant having downy mildew resistance derived from a plant specified in accession number FERM BP-22405, are product by process claims. “The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113 (I). The genus of plants of instant claims 9 & 10 comprising downy mildew resistance and comprising resistance derived from FERM BP-22404 or FERM BP-22405 respectively has no other distinguishing characteristics other than downy mildew resistance and a causative locus for resistance that is also found in FERM BP-22404 or FERM BP-22405. All other traits and genotypic markers may differ from FERM BP-22404 or FERM BP-22405. Furthermore, since FERM BP-22404 or FERM BP-22405 both comprise an additional locus for downy mildew resistance, the plants of claim 9 and 10 do not even require that the RTM-1 gene be derived from FERM BP-22404 or FERM BP-22405. Boshoven’s plants, comprising a gene that reads on RTM-1 and downy mildew resistance, thus anticipate a plant of instant claims 9 & 10 because they are indistinguishable from the plants of the instant claims.
Claims 1-5, 8-10 & 19 are anticipated by or obvious in view of Boshoven.
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.
Claim(s) 1-13 & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Laan et al WO 2020/239215 A1 (published 12/3/2020 with a priority date of 5/29/2019, hereafter Laan) in view of Feitsma et al US 2019/0104700 A1 (published 4/11/2019, hereafter Feitsma).
Claim 11 is drawn to a downy mildew resistant plant having at least one type of downy mildew resistance gene besides the RTM-1 gene.
The teachings of Laan are presented above. Laan does not teach a plant comprising a downy mildew resistance gene besides the gene that reads on RTM-1.
Feitsma teaches that downy mildew is a major threat for spinach growers which makes the leaves unsuitable for sale and consumption (paragraph [0006]). Feitsma teaches that resistance genes against downy mildew in spinach has led to an arms race in which a new R-gene has to be introduced to re-establish resistance in a plant, and so durability of R-genes is low (paragraph [0007-0008]). Feitsma teaches that non-R-gene mediated defense mechanisms provide resistance against a broader spectrum of pathogen races (paragraph [0011]).
Feitsma teaches introduction of a p10 resistance locus into spinach plants to provide resistance to downy mildew races Pfs1-16 (paragraphs [0117-0119], Table 3). Feitsma envisions plants that exhibit complete resistance due to the presence of one or more RPF R-genes in addition to a p10 locus (paragraph [0052]).
Prior to the filing of the instant application, it would have been obvious to one of ordinary skill in the art to obtain a spinach plant comprising an S. tetrandra introgressed resistance locus on chromosome 4 and also comprising an RPF R-gene and/or a p10 locus of Feitsma. One of ordinary skill in the art would have been motivated to combine the resistance allele of chromosome 4 with additional resistance loci such as RPF and p10 because Feitsma teaches that resistance genes have led to an arms race. In addition, the p10 locus provides resistance against a broader spectrum of pathogen races. One of ordinary skill in the art would have had reasonable expectation of success, because pyramiding resistance traits was routine in the art prior to the instant filing, and Feitsma envisions stacking other downy mildew resistance traits into a spinach plant.
Claims 1-10, 12-13 & 19 have been mapped to the teachings of Laan above.
Thus, claims 1-13 & 19 are obvious over Laan and Feitsma.
Conclusion
No claims are allowed.
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/VICTORIA L DELEO/ Examiner, Art Unit 1662
/Anne Kubelik/Primary Examiner, Art Unit 1663
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