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 elected, with traverse, Group II, Claims 9-12 and 20-21. Accordingly, only the elected invention (Group II) is examined in the present Office action. Claims 1-8, 13-19, and 22-23 are withdrawn from consideration.
Response to Argument
Applicant's election with traverse of Group II, claims 9-12 and 20-21 in the reply filed on June 5, 2026 is acknowledged. The traversal is on the ground(s) that the search and examination of the elected method claims necessarily overlaps with and encompasses the search and examination of the plant, seed, propagation material, and breeding method claims because all groups involve a spinach plant comprising the alpha-WOLF allele and therefore do not impose a serious search burden. This is not found persuasive because although the groups share the alpha-WOLF allele as a common feature, Group I is directed to plant, seed, and propagation material compositions, Group II is directed to identification and selection methods, and Group III is directed to breeding and production methods. The searches required for these groups are not coextensive and require consideration of different claims limitations and different areas of prior art. Therefore, examination of all groups would impose a serious search and examination burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-8, 13-19, and 22-23 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on June 5, 2026.
Claim Status
Claims 1-23 are pending.
Claims 9-12 and 20-21 are pending and under examination.
Claims 1-8, 13-19 and 22-23 are withdrawn from consideration as being directed to a non-elected invention.
Claim Objections
Claim 9 is objected to because of the following informality:
“….plant identified as comprising the allele of the alpha-WOLF gene invention for exhibiting resistance to Peronospora effuse”. “Peronospora effuse” should be “Peronospora effusa”;
“ii) a nucleotide ….. SEQ ID NO: 11 (nucleotide sequence (i))”, should be “(nucleotide sequence (ii))”.
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 9-12 and 20-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without reciting significantly more.
Claims 9-12 and 20-21 are directed to a process and therefore fall within a statutory category of invention.
Claims 9-12 and 20-21 recite an abstract idea. Specifically, the claims recite collecting genetic information from a spinach plant, analyzing the information to determine whether the plant possesses a particular alpha-WOLF allele, and identifying or selecting the plant based on the results of that analysis. Such steps constitute observation, evaluation, judgment, and selection based on information, which is an abstract idea.
For example, claim 9 recites detecting by genetic analysis the presence of a nucleotide sequence, amino acid sequence, LRR-domain sequence, or polymorphism associated with an alpha-WOLF allele and identifying the spinach plant based on that determination. Claim 12 similarly recites identifying the presence of the allele and selecting a plant based on the result of the identification. Claims 10 and 11 further limit the genetic analysis to PCR amplification using particular primers, while claims 20 and 21 further require testing for resistance. However, these additional limitations do not alter the fundamental character of the claims as being directed to the collection and analysis of information followed by identification or selection based upon that information.
The claims do not integrate the abstract idea into a practical application. The additional elements recited in the claims include genetic analysis, amplification of a target sequence using primers, optional resistance testing, and selecting a plant based on the detected genetic information. These steps merely use conventional laboratory techniques to obtain information and use that information to identify or select a plant.
The claims do not recite a technological improvement to genetic analysis, PCR amplification, sequence detection, or plant breeding. The claims also do not recite a transformation of the plant, introduction of the allele into a plant, modification of the plant genome, or any other practical application that imposes a meaningful limit on the abstract idea. Instead, the claims merely apply the abstract idea of analyzing genetic information and making a selection based on the results. Accordingly, the claims do not integrate the judicial exception into a practical application.
The claims do not recite additional elements that amount to significant more than the abstract idea itself. Genetic analysis, PCR amplification, sequence detection, resistance testing, and selecting plants based on genetic information are well-understood, routine, and conventional activities in the field of plant genetics and marker-assisted breeding.
Viewed individually and as an ordered combination, the additional elements merely gather information, analyze that information, and use the results to identify or select a plant. The claims therefore amount to no more than instructions to apply the abstract idea using routine techniques.
Therefore, claims 9-12 and 20-21 are not patent eligible under 35 U.S.C. 101.
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 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 9-12 and 20-21 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.
Claims 9 and 12 are rejected as indefinite because the recited SEQ ID NOs are inconsistent with the sequence descriptions and therefore fail to particularly point out and distinctly claim the subject matter regarded as the invention.
Specifically, Claims 9 and 12 recite “ i) a nucleotide sequence comprising a coding sequence having at least 97% sequence identity to SEQ ID NO: 10; or ii) a nucleotide sequence encoding a protein which has an amino acid sequence having at least 93.5% sequence identity to SEQ ID NO: 11; or iii) a nucleotide sequence encoding an LRR domain wherein the nucleotide sequence has at least 94.5% sequence identity to SEQ ID NO: 12; or iv) a nucleotide sequence encoding an LRR domain, wherein the LRR domain comprises an amino acid sequence having at least 93% sequence similarity to SEQ ID NO: 13”.
However, the sequence description identifies:
SEQ ID NO: 9 as the nucleotide sequence of the LRR domain;
SEQ ID NO: 10 as the amino acid sequence of the LRR domain;
SEQ ID NO: 11 as the full-length nucleotide sequence of the alpha-WOLF 23 allele;
SEQ ID NO: 12 as the full-length amino acid sequence encoded by the alpha-WOLF 23 allele.
Accordingly, the SEQ ID NOs recited in the claims do not correspond to the sequence types described in the sequence listing and sequence description. As a result, it is unclear which sequences are intended to define the claimed coding sequence, encoded protein, LRR-domain nucleotide sequence, and LRR-domain amino acid sequence limitations.
Because the claim language and sequence descriptions are inconsistent, one of ordinary skill in the art would not be able to determine the metes and bounds of the claimed invention with reasonable certainty. Dependent claims 10-11, 20, and 21 are included in this rejection because they do not include additional limitations to resolve the ambiguity.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Descriptions
Claims 9-12 and 20-21 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 Federal Circuit has clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials". University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not description of that material". Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus". Id.
Claims 9-12 and 20-21 are directed to methods of identifying or selecting spinach plants comprising an alpha-WOLF allele that encodes a CC-NBS-LRR resistance protein. The claimed allele is defined by sequence identity/similarity ranges and by a race-specific resistance profile, namely resistance to Peronospora effuse races Pe:3, Pfs:5, Pe:8, Pe:9, Pe:1 1, Pe:14 and Pe:16 and does not confer resistance to races Pe:2, Pe:4, Pe:6, Pe:7, Pe:10, Pe:13, Pe:15 and Pe:18.
The specification discloses only alpha-WOLF 23 and its corresponding race-specific resistance profile (pa0048-0049 and pa0067-0068; Table 1). The specification does not disclose additional alleles within the claimed sequence identity/similarity ranges that have been shown to retain the same combination of resistance to Pe:3, Pfs:5, Pe:8, Pe:9, Pe:1 1, Pe:14 and Pe:16 and non-resistance to Pe:2, Pe:4, Pe:6, Pe:7, Pe:10, Pe:13, Pe:15 and Pe:18. The specification further states that variation among alpha- and beta- WOLF alleles is “enormous and not straightforward” and that the resistance pattern conferred by a WOLF allele “cannot be predicted beforehand” (pa0045).
The claims, however, are not limited to alpha-WOLF 23. Rather, the claims encompass alleles having the recited sequence identity/similarity ranges. The specification does not provide representative alpha-WOLF variants across the claimed ranges or identify structure-function correlation or guidance sufficient to demonstrate possession of variants that retain the claimed race-specific resistance profile.
This deficiency is particularly significant because the claimed protein is a CC-NBS-LRR resistance protein. R-gene/NLR resistance is sequence- and race-dependent, and small amino acid changes, particularly within recognition regions such as the LRR domain, can alter resistance specificity. For example, Dodds (P N Dodds et. al., Plant Cell (2001) 13(1):163-178) reported that six amino acid substitutions located in solvent-exposed β-strand/β-turn regions of the LRR domain were sufficient to alter rust resistance specificity in flax L proteins (p163, Abstract). Similarly, Zhang (Jianping Zhang et. al., Nature Communications (2023) Vol14, No 7354, pp1-12) reported that a single amino acid substitution altered resistance specificity of a what stem rust NLP resistance gene (p1 Abstract). Thus, sequence identity or similarity alone does not establish that variants within the claimed genus will retain the same race-specific resistance profile. The specification does not identify which amino acid residues are required for recognition of the claimed races or which sequence changes may be tolerated while retaining the claimed resistance profile.
The claimed allele is not merely defined by resistance to certain races, but also by the absence of resistance to other races. The specification reports this combined resistance/non-resistance profile only for alpha-WOLF 23 but does not disclose additional alleles within the claimed identity ranges that have been shown to retain the same profile.
Scope of Enablement
Claims 9-12 and 20-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specifications, while being enabling for the specifically disclosed alpha-WOLF 23 allele represented by SEQ ID NO:10, 11, 12, and 13, does not reasonably provide enablement for the full scope of alpha-WOLF alleles encompassed by the claimed sequence identity/similarity ranges and the claimed race-specific resistance profile. 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.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
The claims 9-12 and 20-21 encompass alpha-WOLF alleles defined by sequence identity/similarity ranges and require that the encoded protein confer resistance to Peronospora effuse races Pe:3, Pfs:5, Pe:8, Pe:9, Pe:1 1, Pe:14 and Pe:16 and does not confer resistance to races Pe:2, Pe:4, Pe:6, Pe:7, Pe:10, Pe:13, Pe:15 and Pe:18.
The specification teaches that variation among alpha- and beta-WOLF alleles is “enormous and not straightforward” and that the resistance pattern conferred by a WOLF allele “cannot be predicted beforehand” (pa0045). Thus, the specification itself indicates that resistance specificity cannot be predicted from sequence information alone.
To determine whether a variant falls within the scope of the claims, a person of ordinary skill in the art would be required to identify or generated alpha-WOLF variants within the claimed identity/similarity ranges and experimentally evaluate each variant for the claimed resistance profile.
The amount of experimentation is further increased because the claims encompass variants identified by coding sequence identity, protein sequence identity LRR-domain nucleotide identity, and LRR-domain amino acid similarity. The specification provides data for alpha-WOLF 23, but does not provide sufficient guidance to predict which variants within the claimed genus will retain the claimed race-specific resistance profile.
The specification also reports different resistance phenotypes for homozygous and heterozygous plant with respect to Pe:8 and Pe:16 (pa0068 and Table 1), demonstrating that resistance phenotype depends not only on allele sequence but also on zygosity. The claims are not limited by zygosity, and the specification does not provide guidance sufficient to predict the claimed resistance profile across the full scope or plants encompassed by the claims.
Accordingly, undue experimentation would be required to determine which alleles within the claimed identity/similarity ranges satisfy the claimed resistance and susceptibility limitations. Therefore, the specification does not enable the full scope of claims 9-12 and 20-21.
Conclusion
No claims are allowed.
The closest prior art identified is Kock (Vincent Laurens Adrianus Kock et. al., US20190233841A1, Application 2019-03-22, Publication 2019-08-01), which discloses methods for identifying or selecting spinach plants carrying the alpha-WOLF 15 allele. Kock teaches that alpha-WOLF 15 encodes a CC-NBS-LRR protein comprising the alpha-WOLF motifs MAEIGYSVC and KWMCLR, and teaches use of WOLF/LRR sequences and primers for identifying or selecting spinach plants with Peronospora resistance. However, the presently claimed methods are directed to the different alpha-WOLF 23 alleles and requires sequence identity/similarity threshold and a specific resistance/non-resistance profile associated with alpha-WOLF 23 sequence is only about 88% identity, which is below the claimed threshold. in addition, alpha-WOLF 15 has a different resistance profile from alpha-WOLF 23. Although the alpha-WOLF art teaches the general WOLF marker-assisted selection framework and conserved primer-binding/detection concepts, it does not teach or suggest the presently claimed alpha-WOLF 23 allele having the claimed sequence identity/similarity limitations and resistance profile.
Accordingly, the presently available prior art, including Kock, does not disclose or suggest the claimed alpha-WOLF 23 allele having the recited sequence identity/similarity limitations and resistance/non-resistance profile, and therefore does not support a prior-art a rejection of claims 9-12 and 20-21.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YANXIN SHEN whose telephone number is (571)272-7538. The examiner can normally be reached Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at (571)272-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YANXIN SHEN/Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
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