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 .
Claim Status
Claims 1-22 are pending.
Claims 1-6 are examined on the merits.
Election/Restrictions
Applicant’s election of Group I, claims 1-6, drawn to producing/introgression a resistant cucumber plant in the reply filed on 08/21/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
Claim 6 is 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 6 is rejected as indefinite for lacking proper antecedent basis for the phrase “said recombinant chromosomal segment”. Claim 1 recites “a chromosomal segment”, but does not previously characterize that segment as “recombinant”. It is therefore unclear whether “said recombinant chromosomal segment” refers to the chromosomal segment recited in Chaim 1 or to a different chromosomal segment having an additional recombinant characteristic.
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 1-2, and 4-6 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.
The claims are rejected for lacking adequate written description support regarding the broad scope of the following.
Claim 1 recites introgressing into a plant “a CABYV resistance allele” within a chromosomal segment flaked by marker locus M1 and marker locus M2 on chromosome 4, wherein the allele confers increased CABYV resistance. Under the broadest reasonable interpretation consistent with the Specification, the claimed “CABYV resistance allele” is not limited to the particular resistance-associated haplotype present in the deposited seed, the favorable marker alleles reported in Tables 4-6, or the reduced interval flaked by M11 and M113. The specification defines a “resistance allele” as a nucleic acid sequence associated with disease resistance and states that the term may encompass a haplotype allele within a haplotype window or genomic region comprising more than one gene or other genetic factor (pa0075). Claim 1 therefore encompasses structurally different alleles or haplotypes within the approximately 1.82-megabase M1-M2 interval, provided that they confer the recited increase in CABYV resistance.
The specification identifies a QTL on chromosome 4 associated with CABYV resistance within a region extending from 8,682,572 bp to 10,505,14 bp and flaked by M1 and M2 (pa0016-0017). Example 1 reports a highly significant chromosome-4 QTL having a peak at approximately 9,311,653 bp and states that the QTL reduced the maximum infection rate by approximately 42% (pa0085-0088, Table 1-3). Example 2 identifies markers M1-M10 and their respective favorable marker alleles as being associated with the resistance QTL, introgression, and resistance phenotype (pa0089; Table 4). Example 3 validates a reduced 669,866-base-pair interval flanked by M11 at 9,205,907 bp and M13 at 9,876,485 bp, with M12 at 9,7744,356 bp identified as a peak marker (pa0090-0104; Tables 5-6).
However, these disclosures establish an association between particular makers or haplotypes and CABYV resistance; they do not identify the gene, nucleotide sequence, mutation, combination of mutations, or other causal genetic determinants responsible for the resistance phenotype. The Specification states that the chromosome-4 hotspot was evaluated using 10,233 SNPs and that “several mutations in the same genomic area” support the QTL (pa0012; pa0086). Even the reduced M11-M13 interval encompasses 699,866 base pairs (pa0102). The Specification therefore demonstrates that the claimed interval contains substantial structural diversity but does not identify which structural features distinguish operative CABYV-resistance alleles from nonoperative alleles within that interval.
The disclosed markers are described as being associated with the resistance QTL, introgression, or resistance phenotype (pa0089; Tables 4-6). The Specification does not establish that those markers themselves cause CABYV resistance or that the presence of any one listed marker is sufficient to identify the operative resistance determinant. Nor does Specification disclose a representative number of structurally distinct CABYV-resistance alleles reflecting the breadth of the claimed genus or a structure-function correlation by which a skilled artisan could recognize which additional variants or haplotypes within the M1-M2 interval constitute members of the claimed functional genus.
The seed deposited under NCMA Accession No. 202409001 provides a particular cucumber line comprising the disclosed resistance-associated chromosome-4 haplotype (pa0080). The deposit, together with the working examples, may demonstrate possession of that particular resistance-associated germplasm. Nevertheless, claims 1-2, and 4-6 are not limited to the deposited germplasm or its particular haplotype. Reference to a deposit may provide written-description support for the deposited biological material, but it does not demonstrate possession of a broader genus of structurally difference materials that is not otherwise adequately described.
Accordingly, the disclosure reasonably demonstrates possession of particular CABYV-resistance-associated cucumber germplasm and the particular QTL or haplotype disclosed and validated in Examples 1-3. It does reasonably demonstrate possession of the full genus of structurally different CABYV-resistance alleles or haplotypes within the M1-M2 interval encompassed by claim 1.
Claim 2 further recites crossing a cucumber plant comprising the chromosomal segment and selecting progeny comprising the segment. These breeding and selection steps do not further identify or structurally limit the CABYV-resistance allele and therefore do not cure the deficiency of claim 1.
Claim 4 recites that the chromosomal segment comprises any one of marker loci M1-M13. However, claim 4 does not require the favorable allele identified for the selected marker, the complete favorable marker profile reported in Tables 4-6, the deposited resistance haplotype, or another structural feature shown to be responsible for CABYV resistance. The presence of one listed marker locus therefore does not limit the claims to a CABYV-resistance allele shown to have been possessed by the inventors.
Claim 5 further recites backcrossing, marker-assisted selection, or assaying for CABYV resistance. These conventional breeding and screening procedures do not further identify or structurally define the CABYV-resistance allele and therefore do not cure the deficiency of claim 1.
Claim 6 recites a cucumber plant produced by the method of claim 1 and comprising the recited recombinant chromosomal segment. Claim 6 therefore encompasses plants comprising the same broadly can functionally defined CABYV-resistance allele and retains the deficiency of claim 1.
Scope of Enablement
Claims 1-2 and 4-6 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 particular CABYV-resistant cucumber germplasm represented by the deposited seed recited in claim 3, including the disclosed chromosome 4 segment associated with the favorable marker alleles identified in the working examples, does not reasonably provide enablement for the full scope of the claimed invention, including the broader genus of any “CABYV resistance allele” located anywhere within he M1-M2 interval and defined only by its ability to confer increased CABY resistance. 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
Claim 1 encompasses introgression of any CABYV-resistance allele within the approximately 1.82-megabase M1-M2 interval, provided that the allele confers increased resistance to CABYV. The claim is not limited to the particular deposited germplasm, the favorable marker profile reported in Tables 4-6, the reduced M11-M13 interval, or a specifically identified gene, sequence, mutation, or haplotype (pa0016-0017, 0075, 0080, 0089, and 0101-0104). The structural scope of the claim is therefore substantially broader than the particular resistance-associated germplasm and haplotype demonstrated in the working example.
The claimed invention concerns a quantitative viral-resistance phenotype associated with a large chromosomal region. The Specification reports that the chromosome-4 hotspot contained 10,233 evaluated SNPs and states that several mutations within the regions support the QTL (pa0012 and 0086). The Specification further identities multiple QTLs affecting CABYV infection rate on chromosomes 2, 3, 4, and 7 (pa0085-0086; Tables 1-2). These disclosures demonstrate that CABYV resistance is associated with multiple genomic regions and that the chromosome-4 effect is supported by multiple variants rather than a single identified casual mutation.
The Specification does not disclose a sequence- or structure- based rule by which a skilled artisan could predict whether a particular additional variant, recombinant segment, or haplotype within the M1-M2 interval will retain the operative resistance determinant or confer increased CABYV resistance. The favorable marker alleles reported in table 4-6 establish genetic association, but the Specification does not establish that the markers themselves cause the resistance phenotype (pa0089, 0101-0104).
The Specification establishes that crossing, backcrossing, marker-assisted selection, PCR, sequencing, and other marker-detection techniques were generally known to skilled plant breeders (pa0025-0047). These teachings together with the disclosed markers, would permit a skilled artisan to introgress and track the particular disclosed resistance-associated haplotype. Thus, the level of skill and know breeding techniques favor enablement of that particular embodiment. However, the availability of conventional crossing and marker-assay methods does not identify which additional genetic variants or recombinant haplotyptes across the M1-M2 interval will confer the claimed resistance. The Specification provides no causal sequence or predictive structural criteria that would allow those additional operative alleles to be selected without functional screening.
The Specification provides substantial guidance concerning the disclosed resistance-associated QTL. Example 1 describes screening 149 cucumber lines, with 10 plants per line, under open-field conditions and repeatedly testing plants for CABYV infection (pa0081-0088). Example 2 identifies favorable alleles for markers M1-M10 (pa0089; Table 4). Example 3 describes a controlled CABYV bioassay using 105 pedigrees, two replicates of four plants per entry, viruliferous aphid inoculation, and symptom evaluation for up to six weeks (pa0090-0104). The specification also identifies deposited seed containing the disclosed resistance-associated germplasm (pa0080).
These examples enable the skilled artisan to sue the deposited or otherwise disclosed resistance-associated germplasm. They do not provide comparable guidance for identifying additional structurally different resistance alleles or haplotypes throughout the full M1-M2 interval.
To practice embodiments beyond the particular disclosed resistance-associated haplotype, a skilled artisan would be required to generate or locate additional genetic variants or recombinant haplotypes within he claimed interval; determine whether each retains the unidentified operative genetic determinant or determinants; introgress or select the candidate material; and test the resulting plants for CABYV resistance.
The disclosed testing is substantial rather than a simple sequence-based confirmation. Example 1 evaluated approximately 1,490 plants representing 149 lines and repeatedly assayed CABYV infection during the crop cycle (pa0081; pa0087). Example 3 tested eight plants for each of 105 pedigrees and evauated disease symptoms for up to six weeks following controlled aphid-mediated inoculation (pa0090-0092). Because the Specification provides no structural criterion predictive of CABYV resistance, similar crossing, screening, and phenotypic testing would be required to determine whether each additional candidate allele or haplotype satisfies the functional limitation defining the claimed genus.
The issue is not whether a skilled artisan could introgress the particular deposited resistance haplotype using the disclosed markers. The Specification appears to enable that particular embodiment. Rather, the claims are not limited to that haplotype and encompass structurally different CABYV-resistance alleles throughout the M1-M2 interval. Identifying such additional alleles would require a trial-and error search for additional members of the functionally defined genus, rather than routine confirmation of embodiments specifically taught by the Specification.
The breadth and functional nature of the claimed genus, the absence of a disclosed causal determinant or predictive structure-function relationship, and the amount of crossing and phenotypic testing required outweigh the substantial guidance and working examples provided for the particular disclosed haplotype. The Specification therefore does not enable the full scope of claim 1 without undue experimentation. Dependent claims 2, and 4-6 retain the enablement deficiency of claim 1 and are therefore included in this rejection.
Claim 3 is rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claimed invention employs seed of a specific CABYV-resistant cucumber line. Because the seed is essential to practicing the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. The Specification does not disclose a repeatable process for producing the same seed, Although paragraph 0080 identifies a deposit of the seed as NCMA Accession No. 202409001 under the Budapest Treaty, the record does not contain the signed assurance required to establish compliance with 37 CFR 1.808(a), particularly assurance that access to the deposited material will be available during pendency of the application.
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.
Although the rules do not specify a specific number of seeds to be deposited to meet the requirements of these rules, so long as the number of seeds deposited complies with the requirements of the Budapest Treaty International Depositary Authority (IDA) where the deposit is made, the USPTO would consider such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809. Note that the American Type Culture Collection (ATCC), a Budapest IDA, requires a minimum deposit of 625 seeds; other IDAs may have different minimum requirements. Accordingly, any depositor should confirm that the number submitted to a specific IDA complies with that IDA's requirements for seed deposits.
Applicant has indicated that Applicant intends to perfect the deposit in accordance with 37 CFR 1.801-1.809. However, since 37 CFR 1.801-1.809 addresses procedural matters concerning biological deposits and not substantive issues, both Budapest Treaty and non-Budapest Treaty deposits must provide assurances that:
(1) Access to deposited material will be available, during pendency of a patent application making reference to it, to anyone determined by the Director to be entitled to access under 37 CFR 1.14 and 35U.S.C.122 (see In re Lundak, 227 USPQ 90, 94-95 (Fed. Cir. 1985) (citing 35 U.S.C. 114)); and
(2) Subject to paragraph (b) of 37 CFR 1.808, all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.
According, Applicant needs to provide a signed statement providing the assurance above as required to overcome this rejection. Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Conclusion
No claims are allowed.
The closest prior art is Bayer (Cucurbit Aphid-Borne Yellows Virus on Cucumber, March 30, 2022), which teaches that resistance to CABYV had been identified in certain cucumber accessions and that CABYV resistance was not available in commercial cucumber varieties. However, Bayer does not identify the genetic basis of the reported resistance and does not teach or suggest a CABYV resistance allele located within a chromosomal segment on chromosome 4 flanked by marker locus M1 of SEQ ID NO: 1 and marker locus M2 of SEQ ID NO: 10. Bayer also does not teach introgressing that chromosome 4 resistance allele into a cucumber plant, selecting progeny comprising the segment, using the recited chromosome 4 marker loci, or producing a cucumber plant comprising the claimed recombinant chromosomal segment. The remaining prior art of record likewise does not teach or suggest these limitations. Accordingly, the prior art of record, either alone or in combination, does not teach or suggest the claimed method of intorgressing the CABYV-resistance allele located within the specified chromosome 4 segment flanked by marker loci M1 and M2.
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
/WEIHUA FAN/Primary Examiner, Art Unit 1663
