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's election with traverse of the invention of Group I and the species of QTLs 1.1 (SNP_04 to SNP_08), 1.2 (SNP_27 to SNP_31) and 2.1 (SNP_39 to SNP_43) in the reply filed on 22 Oct 2025 is acknowledged. The traversal is on the ground that there is no search burden imposed by searching all the claims and all the species. This is not found persuasive because these species have been appropriately restricted under Unity of Invention practice, which does not consider search burden to determine if Unity of Invention is present.
The requirement is still deemed proper and is therefore made FINAL.
Claim 11 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 1-10 are examined to the extent that they read on the elected species.
Claim Interpretation
For the purpose of examination, the term “cultivated Cucumis sativus var sativus plant” is given its plain meaning and interpreted to encompass any Cucumis sativus var sativus plant that has been or is currently under cultivation, i.e. is grown or raised by humans. Applicant’s provide a description of “Cultivated cucumber” that is narrower than this general understanding, however this description does not draw a clear line between which cucumbers are in the group “cultivated” cucumbers, and which are not (that is, which are members of the group “wild cucumber” or “primitive cucumber”) (specification, page 11, line 28, to page 13, line 3). Therefore, it cannot serve as a definition of “cultivated Cucumis sativus var sativus plant” contrary to the plain meaning of the term because it does not “define” what does and does not constitute such a plant by unambiguous standards—it is not an operational definition.
Applicants limits “cultivated cucumber” to plants of C. sativus var sativus that cultivated by humans and having better agronomic characteristics and having more genetic uniformity (i.e. lower number of SNPs in their genome and lower nucleotide diversity) and physiological and/or morphological trait uniformity, as compared to “wild cucumber” or “primitive cucumber” plants, which applicant states is a group inclusive of landraces (specification, pages 11-12, bridging paragraph). Applicant cites Qi et al (2013, Nature Genetics 45(12): 1510-1518) in support of their claim that “wild cucumbers” have greater SNP and nucleotide diversity. However, Applicant does not make clear which or how many agronomic characteristics must be better to distinguish between a “cultivated” and “wild” cucumber of C. sativus var sativus. How much better? The landraces described in Applicant’s specification have desirable virus resistance QTLs. One of ordinary skill in the art would recognize improved disease resistance as a good agronomic trait. Furthermore, the disclosures of Qi et al do not support Applicant’s distinction. Qi et al’ sample of “Indian cucumbers”, which applicant designates “wild cucumbers”, included both lines of cultivated cucumber, C. sativus var sativus, and the wild relative of cucumbers, C. sativus var hardwickii (page 1510-1511, bridging paragraph). Qi et al further indicate that their data indicate that the Indian group is “basal” in nature (page 1510-1511, bridging paragraph). These two factors explain the genetic heterogeneity of this “Indian group”—it is both a wider sample of taxa and is the source population from which the other geographic groups of Qi et al were derived (the derived lineages would be expected to be less diverse as result from limited geneflow and founder effects). Moreover, Table 1 of Qi et al, as cited by Applicant for support, indicates that the Xishuangbanna group, which is comprised of “19 landraces cultivated in Xishuangbanna region of China” (page 1510-1511, bridging paragraph) has lower SNP and nucleotide diversity than the groups “Eurasian” and “East Asian”, which Applicant cites as exemplars of their definition of “cultivated C. sativus var sativus” plants.
For these reasons, Examiner gives the term “cultivated Cucumis sativus var sativus plant” its plain meaning and interprets it to encompass any Cucumis sativus var sativus plant that has been or is currently under cultivation, i.e. is grown or raised by humans
Claim Objections
Claim1 is objected to because of the following informalities: in line 14 the term “resistance”, or its equivalent, appears to be missing from the phrase “an increase in Tomato Leaf Curl New Delhi Virus strain ToLCNDV-ES and “. 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 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims are indefinite in their recitation of a “a cultivated sativus var. sativus plant” because of Applicant’s discussion of the term in the specification (specification, page 11, line 28, to page 13, line 3). Applicant’s provide a description of “Cultivated cucumber” that is narrower than this general understanding, however this description does not draw a clear line between which cucumbers are in the group “cultivated” cucumbers, and which are not (that is, which are members of the group “wild cucumber” or “primitive cucumber”) (specification, page 11, line 28, to page 13, line 3). Therefore, it cannot serve as a definition of “cultivated Cucumis sativus var sativus plant” contrary to the plain meaning of the term because it does not “define” what does and does not constitute such a plant by unambiguous standards—it is not an operational definition.
Applicants limits “cultivated cucumber” to plants of C. sativus var sativus that are cultivated by humans and have better agronomic characteristics and more genetic uniformity (i.e. lower number of SNPs in their genome and lower nucleotide diversity) and physiological and/or morphological trait uniformity, as compared to “wild cucumber” or “primitive cucumber” plants, a group which applicant considers inclusive of landraces (specification, pages 11-12, bridging paragraph). Applicant cites Qi et al (2013, Nature Genetics 45(12): 1510-1518) in support of their claim that “wild cucumbers” have greater SNP and nucleotide diversity. However, Applicant does not make clear which or how many agronomic characteristics must be better to distinguish between a “cultivated” and “wild” cucumber of C. sativus var sativus. How much better? The landraces described in Applicant’s specification have desirable virus resistance QTLs. One of ordinary skill in the art would recognize improved disease resistance as a good agronomic trait. Furthermore, the disclosures of Qi et al do not support Applicant’s distinction. Qi et al’ sample of “Indian cucumbers”, which applicant designates “wild cucumbers”, included both lines of cultivated cucumber, C. sativus var sativus, and the wild relative of cucumbers, C. sativus var hardwickii (page 1510-1511, bridging paragraph). Qi et al further indicate that their data indicate that the Indian group is “basal” in nature (page 1510-1511, bridging paragraph). These two factors explain the genetic heterogeneity of this “Indian group”—it is both a wider taxonomic sampling and is the source population from which the other geographic groups of Qi et al were derived (the derived lineages would be expected to be less diverse as result from limited geneflow and founder effects). Moreover, Table 1 of Qi et al, as cited by Applicant for support, indicates that the Xishuangbanna group, which is comprised of “19 landraces cultivated in Xishuangbanna region of China” (page 1510-1511, bridging paragraph) has lower SNP and nucleotide diversity than the groups “Eurasian” and “East Asian”, which Applicant cites as exemplars of their definition of “cultivated C. sativus var sativus” plants.
For these reasons, it is not clear what is encompassed by the term “cultivated Cucumis sativus var sativus plant” and the metes and bounds of the claims cannot be determined.
The claims are further indefinite for the recitation of “or said plant comprises at least three introgression fragments … “, in line 3 of claim 1. This renders the claim indefinite because the preceding text of the claim recites both “a cultivated C. sativus var sativus” plant and “a wild cucumber donor”. Therefore, it is unclear to which plant “said plant” refers. For these reasons the metes and bounds of the claims cannot be determined.
Claim Rejections - 35 USC § 112
Written Description
Claims 1-10 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.
Applicant broadly claims a cultivated Cucumis sativus var sativus plants that comprises at least three introgression fragments comprising QTLs 1.1, 1.2 and 2.1, wherein QTL1.1 is located on chromosome 1 between the SNP_01 at nucleotide 51 of SEQ ID NO: 1 and SNP_16 at nucleotide 51 of SEQ ID NO: 16, QTL1.2 is located on chromosome 1 between SNP_17 at nucleotide 51 of SEQ ID NO: 17 and SNP_31 at nucleotide 51 of SEQ ID NO:31, and QTL2.1 is located on chromosome 2 between SNP_32 at nucleotide 51 of SEQ ID NO: 32 and SNP_47 at nucleotide 51 of SEQ ID NO: 47, wherein the introgression fragment comprising QTL 1.1 is homozygous or heterozygous for the SNP markers SNP_04 to SNP_08, wherein the introgression fragment comprising QTL 1.2 is homozygous or heterozygous for the SNP markers 27 to SNP_31, wherein the introgression fragment comprising QTL 2.1 is homozygous or heterozygous for the SNP markers SNP_39 to SNP_43, and wherein the QTLs confer an increase to resistance against ToLCNDV-ES. The claims are further drawn to seeds, fruits, tissues, parts and cells of said plant; said plant wherein the introgression fragments are in homozygous form; said plans wherein the introgression fragments comprising the QTLs are obtainable from NCIMB 43745, PI 605966, CGN22263, CGN22932 or PI 197087 or the QTLs are as present in NCIMB 43745; and said plant wherein the introgression fragment is obtainable by crossing NCIMB 43745 with another plant.
Thus the claims are drawn to a broad genus of cucumber plants, comprising at least one copy of each of three QTLs conferring resistance to ToLCNDV-ES from any source “wild” cucumber plant, or comprising three at least one copy of each of three QTLs conferring resistance to ToLCNDV-ES selected from QTLs that are obtainable from NCIMB 43745, PI 605966, CGN22263, CGN22932 or PI 197087 or the QTLs are as present in NCIMB 43745.
Examiner notes that while the claims recite that the QTLs conferring resistance to ToLCNDV-ES are introgressed from a “wild cucumber donor”, it is not clear how one would determine whether a QTL that conferred said resistance originated from a “cultivated” or donor plant, absent a sequence specific to a wild cucumber donor or, alternatively a location and reference to a wild cucumber donor plant source, such as a deposited plant or publicly available plant.
In contrast to the broad claimed genus, however, applicant describes the cucumber plants NCIMB 43745, PI 605966, CGN22263, CGN22932 and PI 197087—which applicant discloses are resistant to ToLCNDV-ES and which have essentially identical SNP haplotypes across all markers associated with each of the claimed QTLs (see pages 123-135, Examples 1-3, Tables 1-6) and appear to comprise said QTLs homozygously. Applicant discloses that CGN22932 is also known as PI 197087 (see specification, page 83, lines 32-35). Applicant states, on page 135 of the specification, that “As these wild donors have an identical SNP haplotype for the four QTLs (QTL1.1, QTL1.2, QTL2.1 and QTL3.1), except that SNP_09 and SNP_15 of PI605996 is different, it is assumed that these donors contain the same (or variant) QTLs, conferring ToLCNDV-ES resistance” (lines 1-4). Applicant does not describe the source of the QTLs in NCIMB 43745, but describes the plant as an F3 comprising all 4 QTLs in homozygous form (specification, page 124, lines 13-15).
Applicant does not disclose any cultivated cucumber plants comprising QTLs 1.1, 1.2. and 2.1 heterozygously and which have an increased resistance to ToLCNDV-ES conferred by said QTLs.
Saez et al (2021, Microorganisms 9:913, pages 1-17) discloses a QTL on chromosome 2 of PI 197087 (also known by the name CGN23089) that confers the ToLCNDV-ES resistance and appears to correspond to QTL 2.1 of the instant application (see Tables 2, 4 and Figure 5; also throughout). Saez discloses that said resistance is mainly controlled by a single recessive gene and that several other cucurbits likewise comprise recessive genes associated with ToLCNDV resistance (see page 13, paragraphs 1-2).
Applicant does not describe the gene alleles or any causative SNP alleles that confer ToLCNDV-ES resistance—the recited markers are merely correlated with said resistance. Applicant does not describe any other QTLs, beyond those located in the recited locations on chromosomes 1-3 in the genomes of cucumber lines cucumber plants NCIMB 43745, PI 605966, CGN22263, CGN22932 and PI 197087. Applicant does not describe any other sources of resistance beyond these deposited lines.
See Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQe2d 1111, 1115, which teaches that the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his specification. Without both a location for a claimed QTL marker and a source, or a causative SNP allele (as opposed to a correlative marker) it is not clear how a person of ordinary skill would be able to determine if a cucumber plant with ToLCNDV-ES resistance is infringing on the genus of cucumber plants with ToLCNDV-ES resistance as broadly claimed in the instant application.
Therefore, given the lack of written description in the specification, Applicant does not appear to have adequately described the genus of claimed cucumber plants with ToLCNDV-ES resistance.
Insufficient breeding history
Claims 1-10 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 instant Specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because there is no breeding history included in the disclosure (note: a Transmittal Letter is not part of the Specification and cannot provide the written description required to be in the Specification).
Specifically, in the instant application, applicant has only provided a description of the plant traits as seen in the specification. The instant application is incomplete as to the breeding history used to produce the claimed plant line.
35 USC 112 (a) states that “The specification shall contain a written description of the invention”. In evaluating written description, the threshold question is what is “an adequate written description”. This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
In the instant application, Applicant claims a new plant variety and methods of producing or using the variety. This introduces a question of fact: what is an adequate written description of a plant line.
In searching for an answer to the above question of fact, a search of the relevant art provided answers on what constitutes written description of a plant variety. The review concluded that generally the minimum requirements for an adequate description of a new plant variety has a trait table and genetic information (via a breeding history). In reviewing applicant’s specification there is a phenotypic description as is seen in table 1. However, there is no accompanying breeding history in the specification. Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant variety the applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification. The office’s reasonable basis for challenging the adequacy of written description is informed by a review of the following:
With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Variety Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the variety new” (See “Applying for a Plant Variety Certificate of Protection”, USDA, https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023, (U)).
The International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology part of its evaluation of essentially derived plant varieties (UPOV, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30 (V)).
Historically, the USPTO has considered breeding history information when determining the patentability of a new plant variety. (See Ex Parte C (USPQ 2d 1492 (1992) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (X)). In both of these cases, there were many differences cited by the Applicant when comparing the prior art and the new plant variety. However, because the breeding history was available, these differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. Haun et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (Y)) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (p. 645, left column). Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (Z), p. 5430, left column, 1st full paragraph, and right column, 2nd full paragraph). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed to adequately describe a newly developed plant.
The above factual evidence provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary to the adequate description of a plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
MPEP 2163 (I) states “The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").”
MPEP 2163(I) states “The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
The breeding history aids in the resolution of patent infringement by providing information necessary to determine whether differences in the plants are genetic differences, differences caused by the environment, or differences within the accepted variation within a variety.
Moreover, a specification devoid of a complete breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the complete breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, Applicant must amend the specification/drawing to provide the breeding history used to develop the NCIMB 43735. When identifying the breeding history, Applicant should identify any and all other potential names for all parental lines utilized in the development of the instant line and all other potential names for the claimed line. If Applicant’s breeding history uses proprietary cultivar names, Applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar information. If the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If one of the parents is a backcross progeny or locus converted line of a publicly disclosed line, Applicant should provide the breeding history of the parent line as well (i.e., grandparents). Applicant should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant cultivar). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. In the instant application, Applicant has not provided the breeding history of the plant deposited as NCIMB 43745. The donor of the 4 QTLs present in the deposited line and claimed by Applicant is not described. Thus, the breeding history for the claimed cultivar as disclosed in the Specification is incomplete. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
Scope of Enablement
Claims 1-10 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 cultivated Cucumis sativus var sativus plants that comprises at least three introgression fragments comprising QTLs 1.1, 1.2 and 2.1, wherein QTL1.1 is located on chromosome 1 between the SNP_01 at nucleotide 51 of SEQ ID NO: 1 and SNP_16 at nucleotide 51 of SEQ ID NO: 16, QTL1.2 is located on chromosome 1 between SNP_17 at nucleotide 51 of SEQ ID NO: 17 and SNP_31 at nucleotide 51 of SEQ ID NO:31, and QTL2.1 is located on chromosome 2 between SNP_32 at nucleotide 51 of SEQ ID NO: 32 and SNP_47 at nucleotide 51 of SEQ ID NO: 47, wherein the introgression fragment comprising QTL 1.1 is homozygous for the SNP markers SNP_04 to SNP_08, wherein the introgression fragment comprising QTL 1.2 is homozygous for the SNP markers 27 to SNP_31, wherein the introgression fragment comprising QTL 2.1 is homozygous for the SNP markers SNP_39 to SNP_43, wherein the QTLs confer an increase to resistance against ToLCNDV-ES wherein the introgression fragments comprising the QTLs are as present in plants of lines NCIMB 43745, PI 605966, CGN22263, CGN22932 or PI 197087 does not reasonably provide enablement across the full scope of the claims as currently recited. 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 or use the invention commensurate in scope with these claims.
Applicant broadly claims a cultivated Cucumis sativus var sativus plants that comprises at least three introgression fragments comprising QTLs 1.1, 1.2 and 2.1, wherein QTL1.1 is located on chromosome 1 between the SNP_01 at nucleotide 51 of SEQ ID NO: 1 and SNP_16 at nucleotide 51 of SEQ ID NO: 16, QTL1.2 is located on chromosome 1 between SNP_17 at nucleotide 51 of SEQ ID NO: 17 and SNP_31 at nucleotide 51 of SEQ ID NO:31, and QTL2.1 is located on chromosome 2 between SNP_32 at nucleotide 51 of SEQ ID NO: 32 and SNP_47 at nucleotide 51 of SEQ ID NO: 47, wherein the introgression fragment comprising QTL 1.1 is homozygous or heterozygous for the SNP markers SNP_04 to SNP_08, wherein the introgression fragment comprising QTL 1.2 is homozygous or heterozygous for the SNP markers 27 to SNP_31, wherein the introgression fragment comprising QTL 2.1 is homozygous or heterozygous for the SNP markers SNP_39 to SNP_43, and wherein the QTLs confer an increase to resistance against ToLCNDV-ES. The claims are further drawn to seeds, fruits, tissues, parts and cells of said plant; said plant wherein the introgression fragments are in homozygous form; said plans wherein the introgression fragments comprising the QTLs are obtainable from NCIMB 43745, PI 605966, CGN22263, CGN22932 or PI 197087 or the QTLs are as present in NCIMB 43745; and said plant wherein the introgression fragment is obtainable by crossing NCIMB 43745 with another plant.
Thus the claims are drawn to a broad genus of cucumber plants, comprising at least one copy of each of three QTLs conferring resistance to ToLCNDV-ES from any source “wild” cucumber plant, or comprising three at least one copy of each of three QTLs conferring resistance to ToLCNDV-ES selected from QTLs that are obtainable from NCIMB 43745, PI 605966, CGN22263, CGN22932 or PI 197087 or the QTLs are as present in NCIMB 43745.
Examiner notes that while the claims recite that the QTLs conferring resistance to ToLCNDV-ES are introgressed from a “wild cucumber donor”, it is not clear how one would determine whether a QTL that conferred said resistance originated from a “cultivated” or donor plant, absent a sequence specific to a wild cucumber donor or, alternatively a location and reference to a wild cucumber donor plant source, such as a deposited plant or publicly available plant.
In contrast to the broad claimed genus, however, applicant teaches the cucumber plants NCIMB 43745, PI 605966, CGN22263, CGN22932 and PI 197087—which applicant teaches are resistant to ToLCNDV-ES and which have essentially identical SNP haplotypes across all markers associated with each of the claimed QTLs (see pages 123-135, Examples 1-3, Tables 1-6) and appear to comprise said QTLs homozygously. Applicant teaches that CGN22932 is also known as PI 197087 (see specification, page 83, lines 32-35). Applicant states, on page 135 of the specification, that “As these wild donors have an identical SNP haplotype for the four QTLs (QTL1.1, QTL1.2, QTL2.1 and QTL3.1), except that SNP_09 and SNP_15 of PI605996 is different, it is assumed that these donors contain the same (or variant) QTLs, conferring ToLCNDV-ES resistance” (lines 1-4). Applicant does not teach the source of the QTLs in NCIMB 43745, but describes the plant as an F3 comprising all 4 QTLs in homozygous form (specification, page 124, lines 13-15).
Applicant does not teach any cultivated cucumber plants comprising QTLs 1.1, 1.2. and 2.1 heterozygously and which have an increased resistance to ToLCNDV-ES conferred by said QTLs.
Saez et al (2021, Microorganisms 9:913, pages 1-17) teaches a QTL on chromosome 2 of PI 197087 (also known by the name CGN23089) that confers the ToLCNDV-ES resistance and appears to correspond to QTL 2.1 of the instant application (see Tables 2, 4 and Figure 5; also throughout). Saez teaches that said resistance is mainly controlled by a single recessive gene and that several other cucurbits likewise comprise recessive genes associated with ToLCNDV resistance (see page 13, pagargraphs 1-2). Thus there appears to be unpredictability regarding the inheritance patterns of genes conferring ToLCNDV resistance in cucurbits.
Applicant does not teach the gene alleles or any causative SNP alleles that confer ToLCNDV-ES resistance—the recited markers are merely correlated with said resistance. Applicant does not describe any other QTLs, beyond those located in the recited locations on chromosomes 1-3 in the genomes of cucumber lines cucumber plants NCIMB 43745, PI 605966, CGN22263, CGN22932 and PI 197087.
Applicant does not teach any other sources of resistance comprising the claimed QTLs beyond these deposited lines. Applicant teaches that cucumber plants comprising ToLCNDV-ES resistance QTLs on chromosomes 1 and 2 were known in the art at the time filing but Applicant urges that these plants comprise different QTLs and different SNP haplotypes (see instant specification, pages 135-137, Example 4, reference to the plant taught by WO2021019069). Thus, it appears that no other sources of the claimed QTLS are known in the art. Thus in order to identify any sources of ToLCNDV-ES resistance which meet the limitations of the instant claims, one would have to resort to trial and error experimentation to identity them, if they even exist.
Given limited guidance teachings supplied by Applicant, the breadth of the claims, as well as the lack of knowledge in the art, it would have required one skilled in the art undue trial and error experimentation to make and use the claimed invention through the full scope of its claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-10 are rejected under 35 U.S.C. 102(a) as being anticipated by PI605996 (1993, Grin Accession Database, npgsweb.ars-grin.gov/gringlobal/accessiondetail?id=1085683; accessed 10 March 2026) taken with the evidence of Applicant’s own specification.
Applicant discloses that plants NCIMB 43745, PI 605966, CGN22263, CGN22932 and PI 197087—which applicant also discloses are resistant to ToLCNDV-ES and which have essentially identical SNP haplotypes across all markers associated with each of the claimed QTLs (see pages 123-135, Examples 1-3, Tables 1-6) and appear to comprise said QTLs homozygously.
PI605996 is a Cucumis sativus var sativus plant and was collected from a farmer in India (i.e. is cultivated; also see Claim interpretation and 112(b) rejection of claims 1-10), as disclosed by the GRIN database entry.
Regarding the claim limitations drawn to “introgressed”, such language renders the product of claim 1 a “product-by-process”. Any product claimed in a product by process that is the same as, or obvious from, a product of the prior art is upatentable unless the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product (see MPEP 2113). One of skill in the art would not be able to differentiate between an introgressed and naturally occurring QTL based on structure or function.
Thus, PI605996 anticipates all the limitation of the instant claims.
Conclusion
No claims are allowed.
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/ALEKSANDAR RADOSAVLJEVIC/Examiner, Art Unit 1662
/BRENT T PAGE/Primary Examiner, Art Unit 1663
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