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 .
Information Disclosure Statement
Initialed and dated copy of Applicants’ information disclosure statements (IDSs) filed on 04/26/2024, 10/29/2025, and 11/18/2025 are attached to the instant Office action. The submissions are in compliance with the provisions of 37 C.F.R. § 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
The listing of references on pages 6-7 of the Specification is not a proper information disclosure statement. For example, 37 CFR § 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains embedded hyperlink(s) and/or other form of browser-executable code(s); see, for example, page 7 (two instances, ¶0013), page 13 (¶0022). Applicants are required to delete the embedded hyperlink(s) and/or other form of browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Objections
In claim 5, the botanical name “Spinacia tetrandra” should be italicized: ---Spinacia tetrandra---.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 the second paragraph of 35 U.S.C. 112:
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.
Indefiniteness
Claims 6 and 8 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 that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention.
Claims 6 and 8 are indefinite in their recitation(s) of “FERM BP-22426”. Without the proper deposit information (see infra), “FERM BP-22426” is not a term otherwise known in the art. Thus, one of ordinary skill in the art would not be apprised of what the recited plant is being referred to, and as such the metes and bounds of the claims are unclear.
In the interest of compact prosecution, the claims are nonetheless examined.
Enablement, Deposit
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 6 and 8 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 claims contain 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 claims all require seed of mildew resistant spinach plant FERM BP-22426. The invention appears to employ novel plants and seeds.
Since the seeds and plants claimed are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the seed or plant is not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the seeds. A deposit of 625 seeds of each of the claimed embodiments is considered sufficient to ensure public availability. The specification does not disclose a repeatable process to obtain the exact same seeds and plants in each occurrence and it is not apparent if such a seed and plant is readily available to the public.
It is noted that Applicant provides a statement in the Specification at [¶0073] that appears to indicate deposited seeds of this line in the National Institute of Technology and Evaluation (NITE) International Patent Organism Depositary (Room 120, 2-5-8 Kazusakamatari, Kisarazu-shi, Chiba, Japan), with an accession number FERM BP-22426 (accession date: 13 Aug. 2021). However, this statement is inadequate. The Deposit statement must indicate if the deposit is made under the Budapest Treaty or that it otherwise complies with the requirements of 37 CFR § 1.808(a)(2). Further, pursuant to MPEP § 2409, the statement should indicate that the deposit has been accepted.
If the deposit of these seeds 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 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. A minimum deposit of 625 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If a 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 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR § 1.808(a)(2);
(iii) 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 effective life of the patent, whichever is longer;
(iv) evidence will be provided of the test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable (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 § 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 of this title, 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 1-9 and 11-16 are rejected under 35 U.S.C. § 103 as being unpatentable over KOERBER (Koerber et al., United States Patent Application Publication No. 2020/0367460 A1, published 26 November 2020) in view of BRUGMANS (Brugmans et al., PCT International Patent Application Publication WO 2015/054339 A1, published 16 April 2915).
The claims are drawn to a downy mildew resistant spinach plant having a downy mildew resistance RPF-SK1 gene in at least one allele, wherein in the RPF-SK1 gene: (a) a SNP identified by chr3_1215815 is cytosine, (b) a SNP identified by chr3_1215855 is thymine, (c) a SNP identified by chr3_1216014 is cytosine, (d) a SNP identified by chr3_1216093 is guanine, a SNP identified by chr3_1216094 is guanine, and a SNP identified by chr3_1216095 is adenine, (e) a SNP identified by chr3_1216288 is adenine, or (f) a SNP identified by chr3_1216291 is guanine; to progeny of this plant, to methods of producing this plant, to a plant having downy mildew resistance derived from a plant with accession number FERM BP-22426, and to methods for predicting downy mildew resistance of a spinach plant, which comprises investigating genotypes of said SNPs.
KOERBER teaches spinach plants resistant to at least Peronospora farinosa races 8 and 10 to 16 (entire document; see Title, Abstract, for example), and teaches a novel RPF14 gene (or the introgression fragment comprising the gene) that confers resistance against at least Peronospora farinosa races 8 to 16 when the gene is in homozygous form. In one aspect, the RPF 14 gene is linked to the resistant donor nucleotide for SNP 01, which comprises an Adenine (A) at nucleotide 114 of SEQ ID NO: 1 or comprising an Adenine at the equivalent position in a sequence comprising at least 90%, identity to SEQ ID NO: 1 (paragraph 0035).
KOERBER teaches that the RPF14 gene is located on chromosome 3 between SNP 01, at nucleotide 607778 (0.6 Mb), and nucleotide 1219930 (1.2 Mb) of chromosome 3. The chromosome 3 region in which the RPF14 gene is found is thus relatively small (0.6 Mb region). Sequencing or fine mapping can further narrow down the region and Crispr/Cas gene editing of the genes found in the region can be used to show which of the genes introgressed from the wild donor present in the region is responsible for the resistance phenotype (paragraph 0055).
KOERBER teaches methods for generating or identifying a cultivated spinach plant, or a seed, a plant part or a cell (i.e. portion) or a cell culture thereof comprising resistance to at least Pfs races 8 and 10 to 16, preferably races 8 and 10 to 17, and further resistance to Pfs races 1, 2, 6, 7 and 9 at least when the resistance gene is in homozygous form, and resistance to Pfs isolate UA0514. The invention furthermore provides methods for identification, selection, or detection of the RPF14 gene or the introgression fragment comprising the RPF14 gene (paragraph 0053). The RPF14 gene is detectable using one or more nucleic acid probes, nucleic acid primers, or a combination thereof (i.e., kit) (paragraphs 0245-0247).
KOERBER provides DNA markers that can be used in the selection of plants or plant parts or cells comprising the RPF14 resistance gene. One marker provided is the resistant donor nucleotide SNP 01, which comprises an Adenine (A) at nucleotide 114 of SEQ ID NO: 1, or A at the equivalent position in a sequence having at least 90% sequence identity to SEQ ID NO: 1. Other DNA markers linked to the RPF14 gene and/or to the introgression fragment can be developed by the skilled person, e.g. by sequencing the chromosome 3 region comprising the introgression fragment, as e.g. present in the spinach plant deposited as NCIMB42607 (paragraph 0059).
KOERBER further teaches other regions on chromosome 3 that confer downy mildew resistance. For example at paragraph (0143) KOERBER teaches a QTL on chromosome 6 that was described in WO2015054339 (i.e., BRUGMANS) as introgressed from S. tetrandra and confers broad spectrum Pfs resistance, in particular "resistance to races 7, 10, 11, 12, 13, and 14 of Peronospora farinas a f. sp. spinathe (Pfs ), or to races 1-14 and UA4712 of Peronospora farinosa f. sp. spinathe (Pfs)". (UA4712 is Pfs race 15). Chromosome 6 actually corresponds to chromosome 3 in SpinachBase. The two S. tetrandra sequences which flank the QTL are located at 1.4 Mb (SEQ ID NO: 4) and 0.7 Mb (SEQ ID NO: 5).
It is noted that, paralleling the teachings of KOERBER, the instant application also contemplates downy mildew resistance in spinach conferred by the same region on chromosome 3 flanked by positions 1,215,815 and 1,216,291 (instant claims 1, 9, 16).
KOERBER does not explicitly teach the instantly claimed SNPs and methods practiced with them. However, such claimed compositions and methods would have been prima facie obvious to a person of ordinary skill in the art at the time of filing the instant application for the following reasons.
BRUGMANS, cited by KOERBER, teaches methods and compositions for Peronospora resistance in spinach , and provides a Spinacia oleracea spinach plant comprising in its genome an introgressed locus from Spinacia tetrandra that confers broad-spectrum resistance to Peronospora farinosa f sp. Spinaciae. The broad-spectrum 5 resistance comprises resistance to races 7, 10, 11, 12, 13, and 14 of Peronospora farinosa sp. spinaciae (Pfs), or to races 1-14 and UA4712 of Peronospora farinosa f sp. Spinaciae (Pfs ). The spinach plant is defined as an inbred plant, or a hybrid plant (entire document; see Abstract, Summary of the Invention, claim 1 of BRUGMANS, for example).
BRUGMANS teaches an introgressed locus that is defined as flanked in the Spinacia tetrandra genome by sequences at least 95% identical to SEQ ID NOs:1 or 2. In yet another embodiment, a representative sample of seed comprising said locus has been deposited under Accession No. PTA-120533 or Accession No. PTA-120534 (Summary of the Invention).
BRUGMANS teaches that an approximation of the position of downy mildew resistance from S. tetrandra was between markers E33/M62-231 at 0.0 cM and E39/M47-203 at 10.3 cM, on chromosome 6 of the public map (page 23, last paragraph). As explained by KOERBER (above) chromosome 6 described by BRUGMANS actually corresponds to chromosome 3 in SpinachBase.
BRUGMANS teaches that two S. tetrandra accessions, GB1860 and GB1861, found to be resistant to all Peronospora races were crossed to the elite S. oleracea inbred line OEB-66-1056F, and resistant Fl plants were selected. As expected, resistance was found to segregate in the BC1 families, consistent with the heterogeneous nature of S. tetrandra plant introductions. Based on resistance to all officially designated races tested, the two S. tetrandra accessions appear to carry broad spectrum resistance to Peronospora farinosa f sp. spinaciae. Furthermore, studies of BC1 families demonstrated that resistance to downy mildew (DM) from S. tetrandra is heritable and can be introgressed into S. oleracea (page 19, last paragraph).
BRUGMANS teaches that the marker allelic composition of each locus can be either homozygous or heterozygous (page 13, first paragraph).
Given the teachings of KOERBER and BRUGMANS as described above, it would have been prima facie obvious to a person of ordinary skill in the art at the time of filing the instant application to use and to modify the compositions and methods taught by KOERBER and BRUGMANS, and this would result in the Applicants’ invention; with a reasonable expectation of success, and without any surprising results. Obviously, one of ordinary skill in the art would have been motivated to do so for the purpose of producing spinach plants resistant to down mildew (Peronospora farinose), as taught by KOERBER and BRUGMANS.
Although KOERBER and BRUGMANS do not explicitly reduce to practice the instantly claimed SNPs on chromosome 3, these particular embodiments would be considered routine optimization and a design choice that would be readily apparent to one of ordinary skill in the art. The cited art teaches downy mildew resistance conferred precisely by this relatively small region on chromosome 3 from Spinacia tetrandra, which is also claimed in the instant application. Applicants have merely identified several additional SNPs in this known region, and for the known function.
The compositions and methods taught by KOERBER and BRUGMANS would also result in the generation of spinach plants comprising the instantly claimed chromosomal segment from Spinacia tetrandra , thus resulting in a downy mildew resistant spinach plants such as the one deposited by Applicants as FERM BP-22426; as desirable optimization of the methods and a design choice that would be readily apparent to one of ordinary skill in the art, absent evidence to the contrary. Indeed, both KOERBER and BRUGMANS deposited similar spinach plants having downy mildew resistance.
The identification of markers, alleles, and SNPs associated with downy mildew resistance in spinach, the introgression of chromosomal segments conferring resistance, the production of hybrid spinach plants, are techniques that were routine in the art at the time the application was filed, as taught by the cited references and the state of the art in general.
Summary
No claim is allowed.
Examiner’s Contact Information
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BRATISLAV STANKOVIC, JD, PhD
SPE, Art Units 1661 & 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662