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 .
Restriction/Election
In response to the communication received on February 2nd, 2026, from Karen A. Magri, the election with traverse of Group I, claims 1-16, is acknowledged.
Applicants contend that the technical feature common to all of claims 1-38 is a Peronospora effusa resistant spinach plant comprising a resistance genotype at SNP marker 11 and that this technical feature is not disclosed or suggested by Dijkstra.
Applicants’ arguments have been carefully considered but they are not found persuasive. Applicants’ abstract of the invention reads:
“The present invention relates to spinach plants displaying resistance to Peronospora effusa. The present invention also relates to seeds and parts of said plants, for example leaves and heads. The present invention further relates to methods of making and using such seeds and plants. The present invention also relates to genetic sequences associated with said resistance to Peronospora effusa and to molecular markers associated with said genetic sequences.”
Thus, Examiner respectfully maintains that a spinach plant displaying resistance to Peronospora effusa appears to be the common technical feature. Regarding Dijkstra (US-20190185878-A1), the reference discloses cultivated spinach (S. oleracea) seeds, plants and plant parts grown from the seeds that are resistant to Peronospora farinose f. sp. spinaciae (synonym P. effusa) [¶13]. The Groups include additional features not required by other groups [see, Requirement for Restriction, pg. 4, ¶4-5 & pg. 5, ¶1].
Applicants have further elected, without traverse, S. oleracea line 21BNL002487. Applicants point out that both deposited lines are derived from the same haplotype at markers 1 to 11 [see, Example 4, page 62, first two paragraphs]. Examiner notes that Example 4 states the same S. oleracea line as Example 2, S. oleracea line 21BNL002487 (see, Example 2, page 53, paragraph 3), not the second line, S. oleracea line 21BNL002472. This appears to be a typographical error.
Example 4 states that the second recombination was produced from the same wild Spinacia turkestanica source (accession KK016), but using a different cultivated S. oleracea line as the recurrent parent. Example 4 additionally states that both parents have the same fixed Peronospora effusa resistance, but does not provide an origin for the commercial S. oleracea parental line. Thus, as the different parental history of the two lines is relatively unknown, the requirement for election is maintained.
The requirement is still deemed proper and is therefore made final.
Priority
Applicant’s claim for the benefit of a prior-filed application EP21212976.1 filed 12/07/2021 and 371 of PCT/EP2022/084413 filed 12/05/2022 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Thus, the earliest possible priority for the instant application is December 7th, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/26/2024 and 11/03/2025 were considered, initialed, and attached hereto. A signed copy of the list of references cited is included with this Office Action.
Status of Claims
Claims 1-38 filed March 15th, 2024, are pending.
Claims 17-38 are withdrawn.
Claims 1-16 are examined herein.
Claim Objections
Claims 1-16 are objected to because of the following informalities: In claim 1, lines 1-3 and 7-8, “Spinacia oleracea” and “Peronospora effusa” should be italicized. Claims 2-16 are also objected to insofar as they depend from claim 1 and additionally contain “Spinacia oleracea” and “Peronospora effusa” lacking proper italics. Appropriate correction is required.
Claim Interpretation
Claims 11 and 13-14 recite S. oleracea line 21BNL002487. In the instant disclosure, this is identified as a S. oleracea plant with introgressed resistance introduced from a wild S. turkestanica accession KK016 (CGN080741) [Example 2]. The plant was then backcrossed and selfed to fix the resistance into the genetic background. Although CGN080741 appears to be an accession of the Centre for Genetic Resources, the Netherlands (CGN) collection, this accession was not available in the CGN collection as of 03/34/2026 (date of examination). KK016 was reported to be collected in Uzbekistan for the CGN in 2008, as reported by Kik, C. et al. (2008, “Report of a Spinacia collecting expedition to Uzbekistan and Tajikistan,” Centre for Genetic Resources, the Netherlands (CGN)). Thus, the S. turkestanica accession used for examination purposes is that of the report by Kik.
Example 4 of the instant disclosure states the same S. oleracea line as Example 2, S. oleracea line 21BNL002487 (see, Example 2, page 53, paragraph 3), not the second line, S. oleracea line 21BNL002472. This appears to be a typographical error. S. oleracea line 21BNL002487 is interpreted to be the result of Example 2 and 21BNL002472 the result of Example 4 based on the deposit numbers.
Examiner’s Note
Examiner notes that, although claim 1 recites that the Spinacia oleracea plant may be optionally a cultivated Spinacia oleracea plant, Spinacia oleracea is known as a cultivated spinach. Thus, even though the claims are directed towards biological processes, a rejection under 35 USC § 101 would not be proper.
Claim Rejections - 35 USC § 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.
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 1-12 and 15-16 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 recites a Spinacia oleracea plant with enhanced resistance to Peronospora effusa comprising an introgressed sequence that confers a qualitative and dominant resistance to Peronospora effusa located on chromosome 3 and comprising a G genotype in the heterozygous or homozygous states for SNP marker 11 in SEQ ID No. 55. Based on the instant disclosure, it is unclear if the introgressed sequence is the feature conferring the full resistance. Table 2 of the instant disclosure suggests that the combined resistances of the S. oleracea and S. turkestanica sourcesis what provides resistance to P. effusa (see Table 2 below). The nature of the sequence conferring resistance is unknown and undefined in the specification. What is the introgressed sequence? How does it confer resistance? It is unclear if the introgressed sequence is meant to be from a single source to provide resistance or if it is combined with another source to provide resistance.
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Claim 1 recites, “said introgressed sequence is located on chromosome 3 and comprises a G genotype in the heterozygous or homozygous state for SNP marker 11 in SEQ ID NO. 55.” Claims 2-5 and 9-10 further comprise undefined SNP markers and/or PCR primer sets. It is unclear how one of ordinary skill in the art would identify such a SNP. It is assumed that this is the resistance genotype based on Table 3 of the instant disclosure, which lists the alterative genotype, seemingly the lack of resistance genotype, as A/A, and the ADQ genotype as G/G for marker 11. Table 4 of the instant disclosure lists the physical positions of the SNP markers associated with resistance with respect to the spinach-Viroflay_v3 reference genome, denoting marker 11 at 149579722 pb on Spov3_chr3. However, the Sequence Listing (XML file) filed 03/15/2024 shows that SEQ ID NO. 55 is 864 base pairs long with multiple variations and that r may be A or G (see SEQ ID No. 55 below).
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This seems to indicate the resistance allele, but there are discrepancies in the manner of defining the SNPs. For example, SEQ ID NO. 25 showing marker 5 does not include a variation that is an r allele (see SEQ ID NO. 25 below). As such, the resistance allele is unclear because of the variable definitions of the SNP markers.
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Claim 10 also recites the limitation "the plant according to claim 1, wherein: the A genotype for SNP marker 1 can be identified…" in lines 1-3. Claim 10 further recites the genotype for markers 2-10. As claim 10 is dependent on claim 1, which does not recite any markers other than 11. Claim 10 appears only to have antecedent basis for the identification of the PCR sets for marker 11. There is insufficient antecedent basis for this limitation in the claim.
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.
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
Claim 1, and claims 2-11, 12 and 15-16 depending therefrom, 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 and 2-10, 12, 14 and 15-16 are also rejected insofar as they depend from claims 1 or 13, and do not overcome the stated rejections.
The claims are broadly drawn to a Spinacea oleracea plant with enhanced resistance to all Peronospora effusa comprising an undefined introgressed sequence that confers a qualitative and dominant resistance to Peronospora effusa, wherein the introgressed sequence is located on chromosome 3 and comprises SNP marker 11 and optionally one or more of SNP markers 1-10. Claims 11 is further drawn to a S. oleracea line, 21BLN002487, comprising the introgressed sequence.
The instant disclosure describes Peronospora effusa resistance from a wild S. turkestanica accession with broad spectrum resistance introduced to two different lines of S. oleracea with fixed resistance for resistance to P. effusa races 1-18 with SNPs described. The instant disclosure describes SNP markers 1-11 associated with “ADQ” Peronospora effusa resistance with respect to the spinach-Viroflay_v3 reference genome.
The instant disclosure does not describe that the introgressed sequence confers a qualitative and dominant resistance to all Peronospora effusa races in any S. oleracea plant. The instant disclosure does not describe a representative number of resistance S. oleracea with enhanced resistance to Peronospora effusa with only one of the claimed SNP markers.
Table 2 of the instant disclosure shows a combination of resistance from the S. oleracea and S. turkestanica sources, where the S. oleracea source confers resistance to Pe 1-7, 11, 15-16, and 18, and S. turkestanica source confers resistance to Pe 1-3, 5-15, and 17-18. The introgressed sequence is from S. turkestanica (accession KK016) with broad spectrum resistance being introduced to a cultivated S. oleracea with the genetic elements underlying resistance tightly linked on chromosome 3.
With the introgressed sequence, not all lines of S. oleracea may confer resistance to all Peronospora effusa. For example, Viroflay is an heirloom variety of Spinacia oleracea. The instant disclosure teaches that Viroflay was susceptible to P. effusa races 1-19 [Table 1]. The S. turkestanica source does not provide complete resistance, as shown above and in Table 2, thus without the source of S. oleracea provided in the instant disclosure, resistance to all Peronospora effusa or P. effusa races 1-18, as in claim 6, may not be obtainable. The Applicant concedes that combining resistances of the S. oleracea source and the S. turkestanica source did not provide resistance to P. effusa race 19 [Table 2], thus the entire genus of “P. effusa resistance” is not reduced to practice in any S. oleracea plant. A sufficient number of species was not reduced to practice compared to the size of the claimed genus. Thus, in the instant disclosure, the description of SNPs is not sufficient to provide adequate written description. The instant description fails to provide written description in the specification and the claims with regard to the structural and functional characteristics necessary and thus has not demonstrated possession of the genus as broadly as claimed to one of ordinary skill in the art at the time of filing.
It would not be clear to one of ordinary skill in the art that one would be in possession of a S. oleracea plant with enhanced resistance to P. effusa given only one of the SNP markers, because with a single SNP, rather than flanking markers, it would be possible for the resistance trait to become unlinked from the single SNP. In the art, reliability of selection has been demonstrated to be much greater when flanking markers are used over single markers. For example, Akhtar, S. et al. (2010, “Marker assisted selection in rice,” Journal of Phytology, 2(10):66-81) teaches that the use of flanking or intragenic markers will greatly increase the reliability of the markers to predict phenotype, displaying that recombination may occur in approximately 5% of the progeny using a single marker within 5 cM of a target locus, while the change of recombination between two markers, each around 5 cM away from the target locus, is approximately 0.4% [pg. 69, col. 2, ¶1; Fig. 1]. The instant disclosure fails to provide written description to support the structure of a singular SNP reliably being diagnostic without the additional markers.
Examiner notes that claim 11 is drawn to specific S. oleracea lines comprising the introgressed sequence. This does not overcome the written description rejection as the instant disclosure does not describe that the defined lines are resistant to all Peronospora effusa races.
Claim Rejections - 35 USC § 112(d)
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 9 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 1 recites “the introgressed sequence comprising a G genotype in the heterozygous or homozygous state for SNP marker 11 in SEQ ID No. 55,” indicating a sequence with 100% identity to that of SEQ ID No. 55. Claim 9 recites the broader recitation of “the plant according to claim 1, wherein said introgressed sequence comprises one or more of… and/or SEQ ID No. 55, or a sequence that is at least 80% identical to one or more of the foregoing sequences.” Thus claim 9 fails to further limit the subject matter of preceding claim 1. Claim 9 fails the infringement test because claim 9 would conceivably be infringed by sequences other than the full length SEQ ID NO:55, which would not infringe claim 1. See MPEP § 608.01(n).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claims 1-5, 7-10, 12, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Dijkstra, J. et al. “Plants that are Resistant to Downy Mildew,” US Patent Application Publication No. US 20190185878 A1, published 06/20/2019 (as cited in IDS filed 11/03/2025), in view of Kik, C. (2008), “Report of a Spinacia collecting expedition to Uzbekistan and Tajikistan,” CGN Report 12.
Claim 1 recites a Spinacia oleracea plant, optionally a cultivated S. oleracea plant, with enhanced resistance to Peronospora effusa comprising an introgressed sequence that confers a qualitative and dominant resistance to Peronospora effusa, wherein said introgressed sequence is located on chromosome 3 and comprises a G genotype in the heterozygous or homozygous state for SNP marker 11 in SEQ ID NO: 55; wherein the resistance of the plant to Peronospora effusa is enhanced as compared with a S. oleracea plant lacking said introgressed sequence.
Claim 2 recites the plant according to claim 1, wherein said introgressed sequence further comprises a Peronospora resistance-associated genotype at one or more of SNP markers 1-10.
Claim 3 recites the plant according to claim 2, wherein the introgressed sequence comprises the Peronospora resistance-associated genotype at two or more, three or more, four or more, five or more, six or more, seven or more, eight or more, nine or more, or all of the SNP markers 1-10.
Claim 4 recites the plant according to claim 2, wherein the introgressed sequence comprises the Peronospora resistance-associated genotype at two or more, three or more, four or more, five or more, six or more, seven or more, or all of the SNP markers of 3-10.
Claim 5 recites the plant according to claim 2, wherein the introgressed sequence comprises the Peronospora resistance- associated genotype at any of the following combinations of SNP markers: i. 11 and 1; ii. 11 and 2; iii. 11 and 3; iv. 11 and 4; v. 11 and 5; vi. 11 and 6; vii. 11 and 7; viii. 11 and 8; ix. 11, 10, 9 and 8; x. 11, 10, 9, 8 and 7; xi. 11, 10, 9,8,7and 6; xii. 11, 10, 9,8,7,6 and5; xiii. 11, 10, 9, 8, 7, 6, 5 and 4; xiv. 11, 10, 9, 8, 7, 6, 5, 4 and 3; xv. 11, 10, 9, 8, 7, 6, 5, 4, 3 and 2; xvi. 11, 10, 9, 8, 7, 6, 5, 4, 3 and 1; or xvii. 11, 10, 9, 8, 7, 6, 5, 4, 3, 2 and 1.
Claim 7 recites the plant according to claim 1, wherein the plant is heterozygous for the introgressed sequence.
Claim 8 recites the plant according to claim 1, wherein the plant is homozygous for the introgressed sequence.
Claim 9 recites the plant according to claim 1, wherein said introgressed sequence comprises one or more of SEQ ID NO: 5, SEQ ID NO: 10, SEQ ID NO: 15, SEQ ID NO: 20, SEQ ID NO: 25, SEQ ID NO: 30, SEQ ID NO: 35, SEQ ID NO: 40, SEQ ID NO: 45, SEQ ID NO: 50, and/or SEQ ID NO: 55, or a sequence that is at least 80% identical to one or more of the foregoing sequences and comprises the indicated SNP marker genotype.
Claim 10 recites the plant according to claim 1, wherein:" the A genotype for SNP marker 1 can be identified in a PCR by amplification of a nucleic acid fragment with a pair of oligonucleotide primers (see, claims filed 3/15/2024).
Claim 12 recites the plant of claim 1, wherein the plant is an inbred, a dihaploid or a hybrid plant.
Claim 15 recites a seed that produces a plant according to claim 1.
Claim 16 recites a plant part of the plant according to claim 1.
Regarding claims 1-5 and 9-10, Dijkstra teaches a dominant resistance gene, designated RPF12, which confers resistance against all races of Peronospora farinoa [Abstract]. Dijkstra teaches that the invention relates to cultivated spinach, Spinacia oleracea, plants and plant parts, seeds, as well as progenies and plant propagation materials (i.e. a Spinacia oleracea plant, optionally a cultivated S. oleracea plant, with enhanced resistance to Peronospora effusa; wherein the resistance of the plant to Peronospora effusa is enhanced as compared with a S. oleracea lacking said introgressed sequence) [¶02]. Dijkstra teaches that incidence and severity of one of the most damaging pathogens of spinach, downy mildew of spinach, caused by races of the oomycete Peronospora farinosa f. sp. spinaciae (Pfs; synonym P. effusa) has increased concomitantly, with new races continually identified [¶04, 06, 07]. Dijkstra teaches that the resistance is introgressed from wild spinach, Spinacia turkestanica, into cultivated spinach [¶17]. Dijkstra teaches that the RPF12 gene is a single, dominant resistance gene introgressed from Spinacia turkestanica which is closely linked to two SNP markers (i.e. a plant comprising an introgressed sequence that confers a qualitative and dominant resistance to Peronospora effusa) [¶77]. Dijkstra teaches that the introgression fragment comprising the RPFK12 gene is on chromosome 3 of the spinach genome, as found in spinachbase.org (i.e. wherein said introgressed sequence is located on chromosome 3) [¶21].
Dijkstra teaches two SNPs used for identifying the RPFK12 gene is on chromosome 3, but does not explicitly teach the SNP markers of the current invention. However, Kik teaches S. turkestanica with the collection number KK016 collected in Uzbekistan [Appendix III]. The seeds were collected to fulfill present and future breeding needs in Central Asia, which is known to be the biodiversity center of Spinacia turkestanica [pg. 3, ¶1].
Thus, as Dijkstra teaches resistance conferred by an introgression fragment from S. turkestanica to cultivated S. oleracea plants, wherein the resulting S. oleracea plants are resistant to some races of P. effusa, as well as the SNP markers to identify the introgression fragment, and as Kik teaches the accession from which the introgressed broad spectrum resistance was introduced in the instant application (KK016), a S. oleracea plant with enhanced resistance comprising an introgressed sequence from KK016 conferring resistance to P. effusa would have been prima facie obvious to one of ordinary skill in the art at the time of filing. One would have been motivated to combine these teachings as Dijkstra teaches the emergence of new races of P. effusa and that the wild spinach species S. turkestanica provides enhanced resistance over the cultivated S. oleracea, and Kik teaches that the newly collected S. turkestanica accession was for breeding efforts. Additionally, as the resistance gene of Dijkstra does not confer complete resistance against all races of P. effusa, one would have been motivated to try an alternative S. turkestanica species to attempt to confer complete resistance. One would have reasonable expectation of success to confer some resistance as Dijkstra teaches that the resistance gene can be identified in different wild spinach accession, particularly those of S. turkestanica [¶80].
Although Dijkstra and Kik do not explicitly teach the sequences of the SNP markers 1-11 of the instant application and the primers thereof, the ability to identify DNA markers and develop SNP markers is well known in prior art, as suggested by Dijkstra [¶117, 162, 206]. The use of such markers and primers thereof for the selection of plants is routine in the art. The SNP markers in the instant application are some of several possibilities from which one skilled in the art would select in order to solve the problem at hand. Thus, one of ordinary skill in the art would have arrived at the claimed invention without inventive activity. Additionally, the SNP markers as defined (without a position and with conflicting definitions in the instant disclosure, as shown in the written description rejection above) do not allow comparison to the prior art.
Regarding claims 7-8, Dijkstra teaches that a plant of the invention that comprises (retains) the RPF12 resistance gene in homozygous or heterozygous form, and closely linked to molecular marker SNP_01 and SNP_02 (i.e. wherein the plant is heterozygous or homozygous for the introgressed sequence) [¶32].
Regarding claim 12 Dijkstra teaches that the spinach plant may be a hybrid or an inbred plant [claim 4 and 5].
Regarding claim 15-16, Dijkstra teaches a seed from which a plant can be grown (i.e. a seed that produces a plant) [claim 8] and a leaf of a plant (i.e. a plant part of the plant) [claim 9].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Dijkstra and Kik as applied to claims 1-5, 7-10, 12, and 15-16 above, and further in view of Bhattarai, G. et al. (June 26, 2021), “High resolution mapping and candidate gene identification of downy mildew race 16 resistance in spinach,” BMC Genomics, 22:478, and IWPG (April 15, 2021), “Denomination of Pe: 18 and 19, two new races of downy mildew in spinach,” Gouda (The Netherlands), Press release.
Claim 6 recites the plant according to claim 1, wherein said introgressed sequence confers resistance against at least Peronospora effusa races Pe: 1-18.
Dijkstra and Kik teach a S. oleracea plant with enhanced resistance to P. effusa comprising an introgressed sequence that confers a qualitative and dominant resistance to P. effusa as compared to a plant lacking the introgressed sequence, as well as SNP markers. Dijkstra teaches that the S. oleracea plant with the introgressed S. turkestanica resistance is resistant against P. effusa races 1-6, 9-15 and 17 [¶13]. Dijkstra and Kik do not teach that the S. oleracea plant has resistance to P. effusa races 7-8, 16 or 18.
However, Bhattarai teaches a S. oleracea cross between Whale and Lazio S. oleracea cultivars to study the resistance to the P. effusa race 16 (i.e. a S. oleracea plant, optionally a cultivated S. oleracea plant) [pg. 14, col. 1, ¶2]. Bhattarai teaches SNP identification for searching candidate disease resistance genes [pg. 15, col. 2, ¶5]. The hybrid spinach cultivar Whale contains downy mildew resistance locus RPF3, while the cultivar Lazio contains the RPF2 and RPF4 loci, and their resistance responses to the P. effusa races are known [pg. 3, col. 1, ¶3]. Spinach cultivar Whale is resistant to P. effusa races 1–3, 5, 8–9, 11–12, 14, 16, and susceptible to P. effusa races 4, 6–7, 10, 13, 15. Similarly, Lazio is resistant to races 1–10, 15, and is susceptible to races 11–14, 16. Six significant SNPs associated with P. effusa race 16 in the study were close to the annotated disease resistance genes [pg. 14, col. 1, ¶1].
As this is a cultivated S. oleracea hybrid with resistance to P. effusa races, including 7-8 and 16, it would have been prima facie obvious to introgress the sequence further conferring resistance with the cultivated S. oleracea for enhanced resistance to P. effusa, particularly race 17 and 18, in the plant of Dijkstra with the KK016 S. turkestanica cultivar. One would have been motivated to use this cultivar as the selected S. oleracea of Dijkstra and the RPF12 gene had been tested against newly emerging and newly officially recognized races and does not have resistance to these races. One would have reasonable expectation of success as Dijkstra teaches that plants of the species S. oleracea including cultivated spinach, such as breeding lines, cultivars, and varieties, including hybrids may be used [¶24]. Without the commercial S. oleracea female parental line disclosed, it is not possible to determine that the art does not read on the instant invention.
Dijkstra, Kik and Bhattarai do not teach that the plant with said introgressed sequence confers resistance against P. effusa race 18, however, IWGP teaches that race Pe: 18 was denominated along with race Pe: 19 in April of 2021 [pg. 1, ¶1]. IWGP teaches that isolate SP1924 found in Europe, is denominated as race Pe: 18. Resistance to Pe: 18 may be present in the plant of Dijkstra with the introgressed resistance from KK016 and the S. oleracea cultivar of Bhattarai, however, as this is a race that was not denominated before the invention of Dijkstra, it was not a race that was tested. A meaningful comparison with the prior art cannot be made that would render the subject matter of the claims novel.
Examiner notes that claims 11 and 13-14 are not included in this rejection due to the limitation of the deposited line 21BLN002487. The commercial S. oleracea female parent line is not provided in the instant disclosure. Thus, the cross between the KK016 wild S. turkestanica and the undisclosed commercial line is not able to be searched. The line appears to be a commercial S. oleracea line which may be publicly available. Further information is required (see Request for Information under 37 CFR § 1.105 below).
Subject Matter Potentially Free of Art
Claims 11 and 13-14 recite the S. oleracea line 21BNL002487. This F3 line is the result of a wild S. turkestanica species, accession KK016, introduced into a cultivated S. oleracea plant having fixed Peronospora resistance, backcrossed and selfed, and then crossed with a commercial female S. oleracea parent line. Pending receipt of the Request for Information under 37 CFR § 1.105, this line (and perhaps the unelected species, 21BNL002472) may be found free of prior art.
Conclusion
No claims allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY K. JOHNSON whose telephone number is (571)272-5761. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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/EMILY K JOHNSON/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
ATTACHMENT TO OFFICE ACTION
Request for Information under 37 CFR § 1.105
Applicants and the assignee of this application are required under 37 CFR § 1.105 to provide the following information that the Examiner has determined is reasonably necessary to the examination of this application.
This request is being made for the following reasons:
Applicants are claiming two S. oleracea lines, which they have named lines 21BLN002487 and 21BLN002472, but the instant specification inadequately describes what starting materials and methods were used to produce the claimed (spinach) plant. The instant specification merely describes that one parent is the S. turkestanica accession no. KK016 crossed with an undefined commercial S. oleracea parent line. The requested information is required to make a meaningful and complete search of the prior art.
In response to this requirement, if known, please provide answers to each of the following interrogatories eliciting factual information:
Please supply the breeding methodology and history regarding the development of the instant plant.
a) Such information should include all of the public or commercial designations/ denominations used for the original parental lines.
b) Information pertaining to the public availability of the original parental lines should be set forth.
c) The breeding method used should be set forth, such as whether single seed descent, bulk method, backcross method, or some other method was used.
d) The filial generation in which the instant plant was chosen should be set forth.
e) Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
f) Are there any patent applications or patents in which sibs or parents of the instant plant are claimed? If so, please set forth serial numbers and names of the sibs or parents.
If Applicants view any or all of the above requested information as a Trade Secret, then Applicants should follow the guidance of MPEP § 724.02 when submitting the requested information.
In responding to those requirements that require copies of documents, where the document is a bound text or a single article over 50 pages, the requirement may be met by providing copies of those pages that provide the particular subject matter indicated in the requirement, or where such subject matter is not indicated, the subject matter found in applicant’s disclosure. Please indicate where the relevant information can be found.
The fee and certification requirements of 37 CFR § 1.97 are waived for those documents submitted in reply to this requirement. This waiver extends only to those documents within the scope of this requirement under 37 CFR § 1.105 that are included in the applicant’s first complete communication responding to this requirement. Any supplemental replies subsequent to the first communication responding to this requirement and any information disclosures beyond the scope of this requirement under 37 CFR § 1.105 are subject to the fee and certification requirements of 37 CFR § 1.97 if submitted subsequent to a first Office action on the merits.
The Applicants are reminded that the reply to this requirement must be made with candor and good faith under 37 CFR § 1.56. Where the Applicants do not have or cannot readily obtain an item of required information, a statement that the item is unknown or cannot be readily obtained may be accepted as a complete reply to the requirement for that item.
This requirement is an attachment of the enclosed Office action. A complete reply to the enclosed Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the enclosed Office action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY K. JOHNSON whose telephone number is (571)272-5761. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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.
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662