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 .
Claim Status
Claims 1-19 are pending and examined.
Priority
This application is claiming the benefit of Provisional Application No. PCT/EP22/56857 filed March 16, 2022.
Information Disclosure Statement (IDS)
The IDS submitted on 08/29/2024 has been considered. Signed copies is attached.
Claim Objections
Claim 5 is objected to because of the following informalities: the recitation of “races races” is grammatically incorrect. 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 1-10 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 spinach plant that is resistant to downy mildew caused by Peronospora farinosa (Pfs), wherein the spinach plant comprises in its genome a resistance gene”, which is not markedly different from its naturally occurring counterpart because Applicant states that “[a]lthough many alleles have been identified in many different wild spinach accessions on locus 1 and locus 3, none have been identified on locus 6 until now” (i.e. SEQ ID NO: 2) (see spec. page 4 lines 12-13).
Here, the claims are directed to the statutory category of a composition of matter. As described in MPEP § 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s "framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts." Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217-18, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68).
Step 2A requires determining whether the claims are directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea? In this case the judicial exception is the resistance gene (SEQ ID NO: 2) that confers resistance to downy mildew Pfs. Applicant has not claimed a practical application or use of said correlation.
In regard to claims 1-4 and 8, the claims are directed to a wild-type spinach plant comprising a resistance gene against Peronospora farinose (Pfs). Applicant states that “[a]lthough many alleles have been identified in many different wild spinach accessions on locus 1 and locus 3, none have been identified on locus 6 until now” (see spec. page 4 lines 12-13).
Additionally, the specification discloses markers used to identify the natural gene “[p]lants comprising marker 2 (SEQ ID No. 4) and 4 (SEQ ID No. 6) comprised the resistance locus 6 comprising the resistance gene” (pg. lines 32-33). This indicates the claimed spinach and resistance gene (SEQ ID NO: 2) are a product of nature and therefore a judicial exception.
The claims also are directed to a judicial exception that is a naturally occurring correlation between the gene and resistance conferred by said gene.
In regard to claim 5, the claims are directed to the Pfs races to which the plant is resistant. The wild-type plant comprises SEQ ID NO: 2 and Applicant confirms that said gene confers resistance to races 6, 8, and 18 (p.11 table 3).
In regard to claim 6, the claims is directed to a gene “obtainable” from the deposited plant (NCIMB 43935).
In regard to claim 7, the claim is directed to a seed from the plant of claim 1. Since the plant of claim 1 is a naturally occurring plant in the wild, it can produce seed without the hand of man.
Here, none of the claims recite additional elements that integrate the judicial exception into a practical application as the claims are merely drawn to spinach plants and seeds comprising the naturally occurring resistance gene.
Step 2B determines whether the claims recite additional elements that amount to significantly more that the judicial exception?
Here, the claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed invention is directed to naturally-occurring nucleic acid(s) and protein(s) found in spinach plants. Moreover, the claimed nucleic acids, proteins, and plant(s) have inherent properties that are recited in the claims.
Claim Rejections - 35 USC § 112(a)(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.
Claims 1-19 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.
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
Applicant’s disclosure is as follows.
Applicant has described a resistance gene (SEQ ID NOs: 2) in a spinach plant and deposited the seed of said plant under deposit number NCIMB 43935, (pgs. 6-7). Furthermore, the specification describes the resistance was only seen with marker 2 (SEQ ID NO: 4) and marker 4 (SEQ ID NO: 6), (pg. 6 lines 32-33). Lastly, the specification validated that said gene specifically confers resistance to Peronospora farinose races Pfs6 to Pfs8, Pfs10, and Pfs14 to Pfs18 (pg. 11 table 3).
Claims encompass resistance genes having at least 85% sequence identity to Applicants SEQ ID NO: 2
Claims 1-19 are directed to a downy mildew resistant spinach plant comprising a resistance gene having at least 85% sequence identity to SEQ ID NO: 2 and a coding sequence of at least 90% sequence identity to SEQ ID NO: 1 and wherein the plant is resistant to any Peronospora farinosa (Pfs) race.
The specification does not describe the features, motifs, and conserved regions of sequences having as little as 85% sequence identity to SEQ ID NO: 1 and a coding sequence of at least 90% sequence identity to SEQ ID NO: 1 which confers resistance to Pfs.
The specification does not describe any common structures or motifs found within the Pfs resistance gene (also referred as L6 resistance gene) which confers resistance to the broad genus of Pfs as encompassed by the claims. Therefore, one skilled in the art would appreciate that Applicant does not possess the genus of structures as claimed and which retain functionality.
(1) Applicant has not described the structures found with the protein and coding sequence of SEQ ID NOs: 2 and 1, respectively, that confer functionality and (2) has not described a representative number of structures from the genus of structures having at least 85% and 90% sequence identity to SEQ ID NOs: 2 and 1, respectively (e.g., see sequence search results)
The specification describes that SEQ ID NOs: 1-2 was isolated from a specific wild-type spinach but does not describe that these sequences are representative and conserved in other spinach plants. Moreover, the claimed L6 resistance gene (SEQ ID NO: 2) exists exclusively in deposit accession number NCIMB 43935 and is absent from other spinach plants. This resistance gene is unique to this single plant having deposit accession number NCIMB 43935.
Additionally, the specification describes that SEQ ID NO: 2 is a “novel candidate dominant Pfs resistance gene is a so called NBS-LLR type of gene” (spec. pg. 3 lines 8-9). However, the NBS-LRR family are very large family of gene with diverse functions thus there are many different structures that confer function in the gene family.
The specification does not describe any information about the structure of this gene family so one could make a protein having a completely different function that than of conferring resistance.
For example, McHale et al. (“Plant NBS-LRR proteins: adaptable guards” Genome biology vol. 7,4: 212, 2006 (U)) describes that “[t]he majority of disease resistance genes in plants encode nucleotide-binding site leucine-rich repeat (NBS-LRR) proteins. This large family is encoded by hundreds of diverse genes per genome and can be subdivided into the functionally distinct TIR-domain-containing (TNL) and CC-domain-containing (CNL) subfamilies. Their precise role in recognition is unknown; however, they are thought to monitor the status of plant proteins that are targeted by pathogen effectors” (pg. 212.1).
Thus, one skilled in the art would be unable to identify the claimed resistance gene when there is so many genes to look through. Compounding this issue is on has to identify a resistance gene with as little as 85% sequence identity that will retain functional activity and confer resistance to the genus of claimed races.
The specification fails to describe that variants with at least 85% sequence identity will confer resistance against Pfs across all varieties of spinach rendering it unknown if the variants will retain functional activity and confer resistance to the claimed races.
Here, it is not described whether variants of SEQ ID NOs: 1-2 (i.e., sequences with as little as 85% and 90% identity to SEQ ID NOs: 2 and 1, respectively) will retain functional activity because the specification does not describe functional domains or motifs such that one would have no idea if the variants possess the necessary structures to be functionally active and confer resistance.
This description is also critical because Table 3 shows that the gene DOES NOT confer resistance against Pfs 4, 9 and 11 which further suggests that the genus of sequences as encompassed by the claims would not have functionality.
Also note claims encompass more than just 19 pfs as described in the specification. In other words, claims encompass a large genus of sequences that confer resistance to known and yet to be found Pfs.
Furthermore, claims 1-19 encompass a protein sequence having at least 85% identity to SEQ ID NO: 2, or coding sequence having at least 90% identity to SEQ ID NO: 1. This requires the specification to describe nucleic acid sequences encoding such proteins.
However, the specification does not describe a coding sequence having at least 90% identity to SEQ ID NO: 1, or a polypeptide with at least 85% identity to SEQ ID NO: 2, which leads to a functional L6 resistance gene.
A nucleic acid sequence having at least 90% identity to SEQ ID NO: 1 would have 338 nucleic acid substitutions relative to SEQ ID NO:1, while a polypeptide with at least 85% identity to SEQ ID NO: 2 would have 169 amino acid substitutions relative to SEQ ID NO: 2.
These polynucleotide and polypeptides would encompass 3338 and 19169 distinct gene and protein variants, respectively. In the absence of describing where in the sequence of SEQ ID NO: 1 such variations can be sustained, one of skill in the art would not be led to believe that Applicant possesses this vast genus of nucleic and amino acid sequences that retain functional activity, or to the make the polypeptide which would retain the activity of SEQ ID NO: 2, and lead to resistance to Pfs.
Therefore, while the examples describe that a specific L6 resistance gene SEQ ID NOs: 1-2 can confer resistance with spinach, the specification fails to provide adequate description on the motifs, catalytic domains, etc. in these sequences that confers the specifically claimed function of Pfs resistance.
The specification has described one structure/sequence which is not deemed to be a representative number of structures/sequences from the genus of sequences having 90% and 85% sequence identity to SEQ ID NO: 1-2, respectively, that retain function and thus confer Pfs resistance.
Furthermore, the specification has not described if the SEQ ID NO:2 or sequence with at least 85% sequence identity to SEQ ID NO: 2 will confer Pfs resistance in other spinach cultivars.
For example, a blast search of the top ten results shows proteins as unnamed, predicted, and hypothetical genes.
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These alignments (1) do not have high sequence similarity and (2) do not describe structures that confer resistance as claimed. Therefore, based on the state of the art the skilled artisan would not know the structures found within sequence having as little as 85% sequence identity to SEQ ID NO: 2 that confer resistance to the genus of races as claimed.
The lack of a description of a representative number of structures/sequences, the absence of information in the art on conserved regions required for activity, or the impact of 15% variation of the sequence, one skilled in the art would not know the structures conferring claimed resistance. The examples are specific examples tied to a specific starting material, and not reasonably reproducible description to predictably produce downy mildew resistant spinach plants.
Accordingly, there is lack of adequate description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published in Federal Register/ Vol.66, No. 4/ Friday, January 5, 2001/ Notices; p. 1099-1111
Claim Rejections - 35 USC § 112(a)(Enablement)
Claims 1-19, 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 the spinach plant comprising a Pfs resistance gene (SEQ ID NO: 2), specifically to races Pfs6 to Pfs8, Pfs10, and Pfs14 to Pfs18 (pg. 11 table 3), does not reasonably provide enablement for any spinach plant comprising a protein having as little as 85% sequence identity to SEQ ID NO: 2 or a coding sequence having as little as 90% sequence identity to SEQ ID NO: 1, or methods of using said protein. 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 and/or use the invention commensurate in scope with these claims.
“The first paragraph of 35 U.S.C. § 112 requires, inter alia, that the specification of a patent enable any person skilled in the art to which it pertains to make and use the claimed invention. Although the statute does not say so, enablement requires that the specification teach those in the art to make and use the invention without ‘undue experimentation.’ In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
That some experimentation may be required is not fatal; the issue is whether the amount of experimentation required is ‘undue.’” In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991) (emphasis in original); see also In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993) (“[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’”) “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” Wands, supra.
Some experimentation, even a considerable amount, is not “undue” if, e.g., it is merely routine, or if the specification provides a reasonable amount of guidance as to the direction in which the experimentation should proceed. Factors to consider include “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” Id.
Applicant’s disclosure is as set forth above. The claimed invention is not enabled for the following reasons. To comply with 35 USC 112(a) enablement, one skilled in the art must be able to make and use the claimed invention.
(A) The breadth of the claims
The claims encompass any spinach plant comprising a resistance gene having any structure within 85% sequence identity to SEQ ID NOs: 2 providing resistance against a broad genus of Pfs. However, the specification has only taught silencing said gene in spinach (seed deposit NCIMB 43935) already comprising downy mildew resistance to Pfs and SEQ ID NO: 2.
(B) The nature of the invention.
The nature of the claimed invention is directed to any spinach plant comprising a L6 resistance gene having at least 85% sequence identity to SEQ ID NO: 2 and which confers resistance against any Pf.
(C) The state of the prior art
The state of the prior art does not teach structures having at least 85% and 90% sequence identity to SEQ ID NOs: 2 and 1, respectively, that have functional activity and confer Pfs resistance.
(D) The level of one of ordinary skill
The level of one of ordinary skill in the art is high.
(E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Claims 1-19 are directed to downy mildew resistant spinach plant comprising a resistance gene wherein the plant is resistant to Peronospora farinosa (Pfs), specifically at a minimum of races Pfs 6, 8 and 18, obtained from a spinach plant and having at least 85% sequence identity to SEQ ID NO: 2 and a coding sequence of at least 90% sequence identity to SEQ ID NO: 1.
The specification does not provide the adequate amount of direction or guidance regarding the features, motifs, and conserved regions of sequences having as little as 85% sequence identity to SEQ ID NO: 1 and a coding sequence of at least 90% sequence identity to SEQ ID NO: 1 which confers resistance to Pfs.
The specification does not teach common structures or motifs for the Pfs resistance gene or that confer resistance to the genus of Pfs as encompassed by the claims. Therefore, one skilled in the art would appreciate that Applicant does not possess or showing enough working examples of the genus of structures as claimed and which retain functionality.
The specification has failed to teach (1) the structures found with the protein and coding sequence of SEQ ID NOs: 2 and 1, respectively, that confer functionality or (2) provided enough working examples for the genus of structures having at least 85% and 90% sequence identity to SEQ ID NOs: 2 and 1, respectively.
The specification teaches that SEQ ID NOs: 1-2 was isolated solely from a specific wild-type spinach and that is not found in spinach plants. The specification does not teach that these sequences are representative and conserved in spinach plants. Moreover, the SEQ ID NO: 2 is found exclusively in deposit accession number NCIMB 43935 and is absent from other spinach plants. This required resistance is unique to this single plant having deposit accession number NCIMB 43935.
Additionally, the specification teaches that SEQ ID NO: 2 is a “novel candidate dominant Pfs resistance gene is a so called NBS-LLR type of gene” (spec. pg. 3 lines 8-9). However, the NBS-LRR family are very large family of gene with diverse functions thus there are many different structures that confer function in the gene family.
Moreover, the specification does not teach any information about the structure so one could make a protein having a completely different function. For example, McHale et al. (“Plant NBS-LRR proteins: adaptable guards” Genome biology vol. 7,4: 212, 2006 (U) teaches that “[t]he majority of disease resistance genes in plants encode nucleotide-binding site leucine-rich repeat (NBS-LRR) proteins. This large family is encoded by hundreds of diverse genes per genome and can be subdivided into the functionally distinct TIR-domain-containing (TNL) and CC-domain-containing (CNL) subfamilies. Their precise role in recognition is unknown; however, they are thought to monitor the status of plant proteins that are targeted by pathogen effectors” (pg. 212.1).
Thus one skilled in the art would find it be unable to predictably identify and make the claimed resistance gene when there are so many sequences to screen. Adding another layer of unpredictability is one has to identify a resistance gene with as little as 85% sequence identity that will retain functional activity and confer resistance to the genus o fclaimed races.
The specification fails to teach that variants with at least 85% sequence identity will retain function and confer resistance against the genus of Pfs across different spinach varieties. Additionally, the specificaiton has not provided any working example that sequence with at least 85% sequence identity would result in Pfs resistance phenotype.
The resistance observed is tied to this singular, isolated genetic material in a specific plant, and the specification has failed to teach that variants of SEQ ID NOs: 1-2 (i.e., sequences with as little as 85% and 90% identity to SEQ ID NOs: 2 and 1, respectively) will predictably confer resistance which is important because the specification does not teach functional domains or motifs that confer functional activity and will confer resistance. This teaching is also critical because Table 3 shows that the gene DOES NOT confer resistance against Pfs 4, 9 and 11 which further suggests that the genus of sequences as encompassed by the claims would not have the intended functionality.
Also note claims encompass more than just 19 pfs as described in the specification. In other words, claims encompass a large genus of sequences that confer resistance to known and yet to be found Pfs.
Furthermore, claims 1-19 encompass a protein sequence having at least 85% identity to SEQ ID NO: 2, or coding sequence having at least 90% identity to SEQ ID NO: 1. This requires the specification to teach nucleic acid sequences encoding such proteins.
However, the specification does not teach or provide guidance for making a coding sequence having at least 90% identity to SEQ ID NO: 1, or a polypeptide with at least 85% identity to SEQ ID NO: 2, which leads to a functional L6 resistance gene.
A nucleic acid sequence having at least 90% identity to SEQ ID NO: 1 would have 338 nucleic acid substitutions relative to SEQ ID NO:1, while a polypeptide with at least 85% identity to SEQ ID NO: 2 would have 169 amino acid substitutions relative to SEQ ID NO: 2.
These polynucleotide and polypeptides would encompass 3338 and 19169 distinct gene and protein variants, respectively. In the absence of guidance indicating where in the sequence of SEQ ID NO: 1 such variations can be sustained, undue trial and error experimentation would be required to make the claimed coding of SEQ ID NO: 1, or to the make the polypeptide which would retain the activity of SEQ ID NO: 2, and lead to resistance to Pfs.
Therefore, while the examples teach that certain specific L6 resistance gene SEQ ID NO: 2 can confer resistance with spinach, the specification fails to teach motifs, catalytic domains, etc. in these sequences that confer the specifically claimed function of resistance. Applicant has not taught the genus of structure/sequence having 85% sequence identity retain function and thus confer resistance.
For example, a blast search of the top ten results shows proteins as unnamed, predicted, and hypothetical lacking adequate enabling guidance of other resistance genes.
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Therefore, because the art fails to teach the structures required for L6 resistance gene functional activity, a person skilled in the art would be unable to predictably make, and thus use, the claimed amino and nucleic acid sequences as the specification fails to teach the critical domains and motifs that are required for functional activity.
The lack of representative sequences, information on conserved regions required for activity, or the impact of 15% variation of the sequence, shows there is not enough guidance to predictably make and/or use the claimed sequences. The examples are specific examples tied to a specific starting material, and not reasonably reproducible teachings to predictably produce downy mildew resistant spinach plants.
The claimed invention lacks adequate enabling guidance with regard to the genus of spinach plants that comprise L6 resistance gene whereby the plant confers resistance to downy mildew races Pfs 6, 8 and 18.
However, Applicant’s working example is only silencing the L6 resistance gene in spinach (seed deposit NCIMB 43935), a plant that comprises the L6 resistance gene which confers resistance to downy mildew races Pfs 6, 8 and 18. Applicant has not taught transiently expressing SEQ ID NOs: 1-2 in other plants and which display Pfs resistance phenotype.
Given the breadth of the claims, the lack of sufficient guidance, the absence of working examples regarding the structure of L6 resistance gene having at least 85% sequence identity to SEQ ID NO: 2 which confer functional activity, the state of the prior art, and unpredictability in the art, one skilled in the art cannot make and use the claimed invention as commensurate in scope with the claims without excessive burden and undue experimentation.
For at least this reason, the Specification does not teach a person with skill in the art how to make and/or use the subject matter within the full scope of these Claims.
Claim Rejections - 35 USC § 112
Claims 6 and 16 are rejected under 35 U.S.C. 112(a) as containing 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.
Since the seed claimed is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112.
The specification teaches that spinach variety NCIMB 43935 was developed from an initial cross of Spinacia oleracea and undisclosed species, and that it has been judged to be uniform for breeding purposes and testing for Pfs resistance.However, the specification does not disclose a reproducible process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
If the deposit of the seed is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating the seed have been deposited under the Budapest Treaty and that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent would satisfy the deposit requirement made herein.
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 the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that (a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request; (b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent; (c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer; (d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and (e) the deposit will be replaced if it should ever become unviable.
Applicant has NOT deposited the seeds at the NCIMB in accordance with 37 CFR 1.801-1.809 by indicating all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
Applicant has also not indicated an intention to deposit the seeds in accordance with the Budapest Treaty, and by way of affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stated that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent.
Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809, the NCIMB Accession No. and evidence of deposit to overcome this rejection. Alternatively, Applicant may by way of affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, state that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent.Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Subject matter free of prior art
Instant claims 1-19 appear to be free of the prior art. The closest prior art UniProt (Accession K4Q1W5_BETVU, 2013 (V)) which teaches accession K4Q1W5_BETVU having 50.3% sequence identity to SEQ ID NO: 2 and which does not appear to provide resistance to Pfs, as shown below.
RESULT 4
K4Q1W5_BETVU
ID K4Q1W5_BETVU Unreviewed; 967 AA.
AC K4Q1W5;
DT 09-JAN-2013, integrated into UniProtKB/TrEMBL.
DT 09-JAN-2013, sequence version 1.
DT 08-OCT-2025, entry version 55.
DE SubName: Full=Uncharacterized protein {ECO:0000313|EMBL:BAM64835.1};
OS Beta vulgaris (Sugar beet).
OC Eukaryota; Viridiplantae; Streptophyta; Embryophyta; Tracheophyta;
OC Spermatophyta; Magnoliopsida; eudicotyledons; Gunneridae; Pentapetalae;
OC Caryophyllales; Chenopodiaceae; Betoideae; Beta.
OX NCBI_TaxID=161934 {ECO:0000313|EMBL:BAM64835.1};
RN [1] {ECO:0000313|EMBL:BAM64835.1}
RP NUCLEOTIDE SEQUENCE.
RX PubMed=22997236; DOI=10.1534/genetics.112.145409;
RA Matsuhira H., Kagami H., Kurata M., Kitazaki K., Matsunaga M.,
RA Hamaguchi Y., Hagihara E., Ueda M., Harada M., Muramatsu A., Yui-Kurino R.,
RA Taguchi K., Tamagake H., Mikami T., Kubo T.;
RT "Unusual and typical features of a novel restorer-of-fertility gene of
RT sugar beet (Beta vulgaris L.).";
RL Genetics 192:1347-1358(2012).
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DR EMBL; AB646135; BAM64835.1; -; Genomic_DNA.
DR AlphaFoldDB; K4Q1W5; -.
DR ExpressionAtlas; K4Q1W5; baseline.
DR GO; GO:0043531; F:ADP binding; IEA:InterPro.
DR GO; GO:0098542; P:defense response to other organism; IEA:TreeGrafter.
DR CDD; cd14798; RX-CC_like; 1.
DR FunFam; 3.40.50.300:FF:001091; Probable disease resistance protein At1g61300; 1.
DR FunFam; 1.10.10.10:FF:000322; Probable disease resistance protein At1g63360; 1.
DR Gene3D; 1.20.5.4130; -; 1.
DR Gene3D; 1.10.8.430; Helical domain of apoptotic protease-activating factors; 1.
DR Gene3D; 3.40.50.300; P-loop containing nucleotide triphosphate hydrolases; 1.
DR Gene3D; 3.80.10.10; Ribonuclease Inhibitor; 1.
DR Gene3D; 1.10.10.10; Winged helix-like DNA-binding domain superfamily/Winged helix DNA-binding domain; 1.
DR InterPro; IPR042197; Apaf_helical.
DR InterPro; IPR044974; Disease_R_plants.
DR InterPro; IPR032675; LRR_dom_sf.
DR InterPro; IPR055414; LRR_R13L4/SHOC2-like.
DR InterPro; IPR002182; NB-ARC.
DR InterPro; IPR027417; P-loop_NTPase.
DR InterPro; IPR038005; RX-like_CC.
DR InterPro; IPR041118; Rx_N.
DR InterPro; IPR036388; WH-like_DNA-bd_sf.
DR PANTHER; PTHR23155; DISEASE RESISTANCE PROTEIN RP; 1.
DR PANTHER; PTHR23155:SF1205; DISEASE RESISTANCE PROTEIN RPM1; 1.
DR Pfam; PF23598; LRR_14; 1.
DR Pfam; PF00931; NB-ARC; 1.
DR Pfam; PF18052; Rx_N; 1.
DR Pfam; PF23559; WH_DRP; 1.
DR PRINTS; PR00364; DISEASERSIST.
DR SUPFAM; SSF52058; L domain-like; 1.
DR SUPFAM; SSF52540; P-loop containing nucleoside triphosphate hydrolases; 1.
PE 4: Predicted;
KW Nucleotide-binding {ECO:0000256|ARBA:ARBA00022741};
KW Plant defense {ECO:0000256|ARBA:ARBA00022821};
KW Repeat {ECO:0000256|ARBA:ARBA00022737}.
FT DOMAIN 5..90
FT /note="Disease resistance N-terminal"
FT /evidence="ECO:0000259|Pfam:PF18052"
FT DOMAIN 170..427
FT /note="NB-ARC"
FT /evidence="ECO:0000259|Pfam:PF00931"
FT DOMAIN 573..899
FT /note="Disease resistance R13L4/SHOC-2-like LRR"
FT /evidence="ECO:0000259|Pfam:PF23598"
SQ SEQUENCE 967 AA; 110782 MW; 5FA636947871DFE9 CRC64;
Query Match 50.3%; Score 2949; Length 967;
Best Local Similarity 61.3%;
Matches 592; Conservative 136; Mismatches 220; Indels 18; Gaps 11;
Qy 1 MAESVVALVSQWLVSLLKLEADTLFNVADEVKGLQQELELMQAYLRDADARQEEKEVSTL 60
||||:|| ||: ||| | || | ::|:|||||||||| |::|||||| | :| ||
Db 1 MAESIVASAVQWIGSLLVQETSILFGVDEQVRGLQQELELMQQYVQDADARQGEGDVRTL 60
Qy 61 ISQIRKLVYDVEDVIDTYILKVPASTERHMLKRFGRFLYNAPQIYKLGKQMIVMQRDLER 120
| |||:| || ||||| || | | | | ::|: |::|||: |:| ::|
Db 61 IRQIRQLAYDAEDVIDIYIFKDEWRHAEHRLIRLAGYIYSVRNTYRVGKQINVIQGGVKR 120
Qy 121 MTTKLDSCGLTKIAPELKEGFRKLHKEGYWR--APSYSFEDNSCHYVVGLEKDVSKLLEV 178
:| :|: ||: | :| | | | ||||| ||:| :||: :|||||||: ||:||
Db 121 ITERLNDCGMRKTC-KLWERHRLPHDEGYWRRQPPSFSHDDNNGEHVVGLEKDIRKLVEV 179
Qy 179 LIGEGNTHINILSIIGMGGSGKTTLARKLYNHPFVKECFNGMAWVFISQEWSTRHTLLEI 238
|:||||| :|::||:||||||||||||||||||: ||||: ||||||||| | | ||:|
Db 180 LMGEGNTQVNVVSIVGMGGSGKTTLARKLYNHPYAKECFDCTAWVFISQEWRTEHVLLQI 239
Qy 239 LRMVGGQGGTYEL--HAKLSAEALVDKLRGVLKKKSYLIVLDDVWRREALEEILPALPLG 296
|| || : : ||| | |||||| :|::||||:||||||||||||||||| |
Db 240 LRKVGSEPNEKMIKPDTKLSVEELVDKLRNILEQKSYLVVLDDVWRREALEEILPAFPRE 299
Qy 297 DVNK-DSKIIITTRNREVVNFQNLRQ-LFVHEPQPLSKEEGWELFSKLALGHRTDCNMEN 354
| || |||||||||||:: ||||:| |::|||:||::|| ||| :|||| : |:|:
Db 300 DKNKRGSKIIITTRNREIIQFQNLQQNLYIHEPRPLNEEEDWELLNKLALSRQGSHNVED 359
Qy 355 FKSLGMVMLKNCGGLPLAIVALGGILKSRGSIGEWQHMNEAIKVRLMKGLGSNTHSSVQK 414
|: || ||| |||||||| || ||| :| || ||| :|||:: |:|: :| ||:
Db 360 FERLGKEMLKKCGGLPLAIA ALAGILNTRESIAEWQQVNEAVRSRVMENTQTNMGRSVRD 419
Qy 415 LLALSYEDLPYYLKHCFLYLCLFPEDCQIPAGMLTRMWIAEGLITSSEEISPEDVALQYL 474
||||||:|||| || ||||||:|||||||| ||||||||||||: : ||:| ||||:| :
Db 420 LLALSYDDLPYDLKPCFLYLCVFPEDCQIPVGMLTRMWIAEGLVAAHEEMSLEDVAMQLV 479
Qy 475 EELSNRCMIQVVRTNFKGAIKAFHLHDLLRDLCLKIAKEQSFLQICKNNQSMTTFASTMA 534
||||:| ||::||||||||||| |||||||||:: |||::|:|| | ||: |
Db 480 EELSHRFMIKIVRTNFKGAIKAIQLHDLLRDLCVRKAKEENFVQIYTATSSQ---ASSCA 536
Qy 535 VP---PPRRVSLQSSISLPTQDSNLRSLILLTRSSLLQSAKVHKETVDLKLVQNKFQLLR 591
| ||| :| ||| || ||||||||:||||||:: || | |||:||::: |:|||
Db 537 FPLATQPRRAALHSSILLPAQDSNLRSLVLLTRSSIVHSAYVSKETLDLRILHKNFKLLR 596
Qy 592 LLNFWGIKTDDGALPKEIGSLIHLRYLGIRDSNIIELPHSIGNLRNLTTLDYRKIDSVNS 651
||| ||||| | || ||| ||||||| :| ||| ||| ||| |||| ||||| ||| |:
Db 597 LLNLWGIKTATGTLPTEIGELIHLRYLAVRASNITELPRSIGKLRNLMTLDYRNIDSDNN 656
Qy 652 VQIKIPNVLWKLVQLRHLFLPIECVWNTHEELHLSGLENLQILWGIRANGG--DWFSREI 709
: ::|||| || ||:|||||| |: : | :|||:||: |||::: |||||||
Db 657 IPVQIPNVFINLVLLRNLFLPIENAWSL-QRLQVSGLKNLRTLWGVKSEEEDIDWFSREI 715
Qy 710 VNLSMTLKKLKVVVSTQKDLEATFSCPNLKSHQLHTFQCQWGDGIVLGHVNPIFAHNHHL 769
| || |||||||:||| ||||:|:||:| :|:|| ||||||||| ||| | :|| ||
Db 716 VKLSPTLKKLKVIVSTTNDLEASFNCPSLILDRLNTFHCQWGDGIVLQHVNKI-SHNRHL 774
Qy 770 SKLVLIGPVLVK-DFSLILPSNLVILELKESVVDYEDPMAAIGALAHLKLLRLSNAYMGT 828
||||:||: | |::|| |||:|||::|:: ||| ||||| ||||||| | | |
Db 775 HKLVLVGPIHAKLKLSVMLPCNLVMLELRDSILHSVDPMVAIGALTHLKLLRLFNTYTGN 834
Qy 829 TFKCKIGSFPMLEEFHLENLHKLSKWVIEEGAMQSLKTVQISGCRKLQHLPQGLEFVRTL 888
| || |||:||| :||:| |: | :: ||| ||| |:| |:||| |||| |: ||
Db 835 EFLCKTDSFPVLEELYLESLPNLNLWTVQIGAMVSLKKVEILWCKKLQQFPQGLAFITTL 894
Qy 889 QVLEFIGVPKSFVKEATECGWSRKKLRLPHTIDAIIEQCDSPVDFSSISKLYEQLRAGVF 948
| |||:|:|: | :|| | ||||| |:|| ::|||||||: || ||||||| || ||||
Db 895 QQLEFLGMPEEFGREAKESGWSRKGLKLPQNMEAIIEQCDARVDISSISKLYAQLTAGVF 954
Qy 949 LNEKKQ 954
|| |||
Db 955 LNNKKQ 960
Conclusion
No claims are allowed.
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/C.J.O./Examiner, Art Unit 1663 /JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662