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
The Office acknowledges the receipt of Applicant’s restriction election filed June 26, 2026. Applicant elects Group I, claims 1-5, 8-12, and 14 and the species QTL 1.2 and allele G of CU-0004638 consisting of SEQ ID NO :47 wherein nucleotide at position 36 is G, with traverse. Upon further consideration the restriction is withdrawn and claims 1, 3-12 and 14-17 are rejoined.
Claim Status
Claims 1, 3-12 and 14-17 are pending. Claims 2 and 13 are canceled. Claims 1, 3-12 and 14-17 are examined to the extent of the elected species of SEQ ID NO:47 where in nucleotide position 36 is G.
Foreign priority
Applicant claims foreign priority benefit of Application No. EP22305464.4 filed Filing Date 04/06/2022.
Specification
The specification is objected to for the following reasons:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. For example, see page 6, line 3 and page 8, line 8
On pg. 34, lines 17 and 20, the identifiers “CU-0002804 for QTL 1.1, CU6-0005119 for QTL 1.2, and CU0007750 for QTL5” all seem to have different styles or errors found in them (e.g., see also “CU-0007750” designation on p. 45). For example, some have “-“ while others do not or “CU6-0005119” contains a “6” next to the “CU” while the others do not. Some look to be “internal codes”, and the others seem to be SNP_ ID’s. Is this intentional or a discrepancy?
On pg. 40, line 2-3 recites “The Oneway Anova analyses of each SNP allele for each QTL are disclosed in tables 12-14. The marker linked to QTL 1.2 (i.e. CU6-0005119) is explaining 42% of the tolerance or tolerance phenotype observed (Rsquare 0.423506).” However, the specification does not provide a SEQ ID NO. for CU6-0005119 and on pg. 47, table 13 only discloses QTL1.2 CU0005159 and not CU6-0005119. This seems to be a discrepancy.
On pg. 45, Table 11, the lod and %var values have commas instead of decimals. Please replace table with corrected values.
Clarification and/or correction is required.
Claim Objections
Claims 1, 3-12 and 14-17 are objected to because of the following:
In claims 1 and 14, “Sativus” should be lower case.
Dependent claims are included.
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 therefore, subject to the conditions and requirements of this title.
Claims 1, 3-10 and 14-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature in addition to a law of nature/natural phenomenon. The claims encompass a naturally-occurring tolerance gene found in Cucumis sativus plants and methods for detecting plants with said tolerance through a naturally occurring correlation between alleles and tolerance (pg. 8, lines 11-14 and table 7).
The specification discloses QTL1.2 is found in chromosome 1 and located within SEQ ID NO: 36 and SEQ ID NO: 39, which are unmodified sequences from C. sativus. The specification discloses this QTL was determined by screening potential leads and that 60 genotypes were selected (p. 34 at line 24). Lead “Cuc58” was the best lead and mapped to determine the presence of QTLs in resistant plants (p. 39 and Example 3).
Importantly, there is no evidence of record demonstrating that “Cuc58” or progeny therefrom were altered in any way.
Here, the claim(s) recite(s) a Cucumis sativus plant comprising a quantitative trait locus (QTL) on chromosome 1 that confers tolerance to Cucumber green mottle mosaic virus (CGMMV), methods for detecting plants with said tolerance by detecting alleles or assaying for the presence of at least one genetic marker linked to QTL1.2, and methods of growing said plants which are considered judicial exceptions as noted above.
Theses judicial exception are not integrated into a practical application because (1) the product of nature (i.e., a plant with tolerance) does not integrate the plant into a practical application and (2) the methods are not directed to a practical application as they only detect the presence of viral tolerance in a plant. In particular, (2) is nothing more than an attempt to generally link the product of nature to a particular technological environment
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because (1) does not recite any additional elements to the product of nature and (2) screening for alleles or genetic markers are well-understood, routine, conventional that not add significantly more to the naturally occurring correlation between QTL1.2 and tolerance.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to a “Use” and not to a process, machine, manufacture or composition of matter.
Claim Rejections - 35 USC § 112(b)
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, 3-6, 8-12 and 14-16 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.
In claims 1, 4, and 15, it is unclear whether the recitation within parentheses (i.e., the SEQ ID NOs.) is intended to be a claim limitation or a nonlimiting example.
Claims 1, 3, 6, 9, 11, 14 and 15 are drawn to a C. sativus plant tolerant to CGMMV comprising in its genome a QTL on chromosome 1 wherein the QTL is QTL1.2 within a region delimited by SEQ ID NO: 36 and 69.
The metes and bounds of the claim are indefinite because “QTL1.2” is not an art recognized term and is not a structure defined by the specification so that one would not know what is or is not encompassed by the claims. Moreover, “QTL1.2” is defined by function rather than structure: it is a limitation without a disclosed structure in the specification present in a chromosomal region and which confers the function of tolerance to CGMMV.
The recitations “QTL1.1” and “QTL5” as recited in claims 4-6, 8, 9, 11, 14 and 15 present the same issues and are therefore rejected for the same reason as provided for claim 1.
Claims 3, 10, 12 and 16 are rejected for depending upon a rejected base claim and for failing to remedy the issues of indefiniteness.
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, 3-12 and 14-17 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’s disclosure is as follows.
The specification describes QTL analysis on the F2 mapping population derived from a cross of Cuc58.4xCuc61. The specification also identifies individual single nucleotide polymorphisms (SNPs) for QTL1.1 (SEQ ID NOs. 1-35), QTL1.2 (SEQ ID NOs. 36-53) and QTL5 (SEQ ID NOs. 54-64) (Tables 5-10).
Table 11 shows the Lod parameters for each SNP which shows the likelihood of correlation between SNP’s and tolerance within the QTL’s. The highest lod scores were seen in 3 QTL regions “linked to the tolerance: The QTL interval on the beginning of chromosome 1 is between CU-0001726 (pos.450,655) to CU-0001233 (pos. 2,603,822), LOD= 17. The QTL interval on the end of chromosome is between CU-0006143 (pos. 23,286,654) to CU-0000987 (pos. 24,850,252), LOD=40. The third QTL was detected on chromosome 5, is between CU-0000533 (pos. 9,205,026) to CU-0005413 (pos. 12,603,711), LOD=15” (pg. 39, ex. 3).
Specifically, the specification shows the statistical likelihood of the tolerance or tolerance phenotype observed in a single SNP for each QTL1.1 (CU-0002804), QTL1.2 (CU-0005159) and QTL5 (CU-0007750) resulting in a Rsquare value of 0.153, 0.423 and 0.072, which QTL1.2 (CU-0005159) having a marginally higher likelihood of tolerance found within that region.
The claimed invention lacks adequate written description for the following reasons.
Here, the claims are broadly directed to a C. sativus plant or cell comprising a QTL1.2 region delimited by CU-0006144 (SEQ ID NO: 36) and CU-0001483 (SEQ ID NO: 39), which on table 7 identifies these border regions as SEQ ID NO: 36 position 23,301,167 and SEQ ID NO: 39 position 25,331,856.
However, on page 40, line 16-17, the specification describes that the inner borders in Chromosome 1 between 23,286,654 bp (CU-0006143) and 24,850,252 bp (CU-0000987)” have a lod score of 40 which translate in a marginally higher likelihood of comprising tolerance towards CGMMV (pg.39, lines 22-23). As for the outer borders of CU-0006144 (SEQ ID NO: 36) and CU-0001483 (SEQ ID NO: 39) have a much lower lod score and likelihood of tolerance towards CGMMV (table 11).
Therefore, the border outer regions of SEQ ID NO: 36 position 23,301,167 and SEQ ID NO: 39 position 25,331,856 have a lower likelihood of tolerance and the inner regions of 23,286,654 bp (CU-0006143) and 24,850,252 bp (CU-0000987) have a lod score of 40 and a marginally higher likelihood of containing said tolerance activity.
Absent a description that these regions comprise in the genome any number of QTLs that confer tolerance to CGMMV, the skilled practitioner would not believe Applicant possesses the plants and methods as broadly claimed.
Additionally, even though the specification describes the likelihood of tolerance found within said region, the specification does not describe the actual region(s) or gene(s) responsible for said CGMMV tolerance activity. Thus, the claims encompass a very large region comprising 2,030,689 bp contain a genus of undescribed genes that may or may not contribute to said tolerance activity.
Applicant is claiming a large genus of QTLs in an equally large region of chromosome 1 that potentially confers tolerance. However, the specification has not described a representative number of QTL regions actually conferring tolerance. Besides the parent plants comprising the tolerance activity, the specification fails to show additional examples of plants comprising QTL1.2 structures delimited by the region CU-0006144 (SEQ ID NO: 36) and CU-0001483 (SEQ ID NO: 39).
This description is importance because the art describes that QTL mapping for tolerance is unpredictable. For example, Rasool et al. (Global Drug Design & Development Review IX, no. III (2024): pgs. 1-12. https://doi.org/10.31703/gdddr.2024(IX-III).01 (U)), describes that disease tolerance QTL mapping is “troublesome since the trait is complex” and frequently “polygenic” with small effect -loci, which is further complicated because “genotype X environment interactions modify pathogen prevalence and severity” across different conditions (pgs. 2-3).
Additionally, Rasool et al. describes that “false positives are still a serious issue in QTL mapping” and “small-effect QTLs are more difficult to identify, large populations that can also provide extensive genotypic and phenotypic data are needed. Empirical evidence of these challenges emphasizes the importance of using modern statistical tools and modem technology to increase QTL mapping accuracy and efficiency for disease tolerance” (pg. 3, col. 1). Relying on QTL alone would make it unpredictable for one skilled in the art to believe the Applicant is in possession of such a large QTL region having tolerance activity.
Or see the instant specification, which describes that it was known in the art that chromosome 1 confers tolerance to CGMMV in line DRCE1301 as encompassed by claim 1 (p. 40 at line 4). As such, one would be unable to distinguish the plant of instant claim 1 from the publicly available line DRCE1301 as the plant of claim 1 is not required to comprise any allelic differences.
Therefore, without a description of a representative number of structures from the genus of QTL1.2 in the regions as claimed and that confer tolerance or a description of genetic markers linked thereto one skilled in the art would find it hard to believe the Applicant is in possession of such a large QTL region conferring tolerance.
For these reasons, one would also not be of the opinion that Applicant possesses QTL1.1 and QTL5 as broadly claimed.
Moreover, the same could be said with the alleles of said SNP’s, in particular SEQ ID NO: 47, because the specification lacks working examples of said region conferring tolerance. Therefore, one skilled in the art would find it difficult to believe applicant is in possession of the QTL1.2 alleles conferring tolerance in a plant. See also claims 5 and 14 in regard to QTL1.1 and QTL5 alleles conferring tolerance.
In regard to claim 6, it is noted that the limitation “are obtainable” does not limit the claim. Namely, the claims merely recites that the tolerance is found in the deposited variety.
In regard to claim 7, it is noted that there is no limitation on the number of generations for the progeny and plants derived from CUC58.4. As a result, and due to genetic recombination or crossover events the progeny and plant derived from CUC58.4 may not even comprise the necessary QTL required for tolerance. Therefore, the skilled artisan would not be of the opinion Applicant possesses these 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 (Enablement)
Claims 1, 3-12 and 14-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The 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.
Enablement factors to consider include:
(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).
Applicant’s disclosure is as set forth above. The claimed invention is not enabled for the following reasons.
(A) The breadth of the claims;
The breadth of the claims encompasses a C. sativus plant having tolerance to CGMMV, wherein the tolerance is found within the QTL1.2 region delimited by CU-0006144 (SEQ ID NO: 36) and CU-0001483 (SEQ ID NO: 39).
(B) The nature of the invention;
The nature of the claimed invention is a C. sativus plant having tolerance to CGMMV, wherein the tolerance is found within the QTL1.2 region delimited by 23,286,654 bp (CU-0006143) and 24,850,252 bp (CU-0000987).
(C) The state of the prior art;
The state of the prior art does not teach that the QTL1.2 region delimited by CU-0006144 (SEQ ID NO: 36) and CU-0001483 (SEQ ID NO: 39) confers CGMMV tolerance as broadly claimed. The state of the prior art does not teach that the QTL 1.1 located on chromosome 1, within the chromosomal region delimited by CU-0001918 (SEQ ID NO:1) and CU-0006297 (SEQ ID NO:8) confers CGMMV tolerance as broadly claimed. The state of the prior art does not teach that the QTL5 located on Chromosome 5, within the chromosomal region delimited by CU-00005234 (SEQ ID NO: 54) and CU-0007979 (SEQ ID NO:57) confers CGMMV tolerance as broadly claimed.
This guidance is critical because Rasool et al. teaches that disease tolerance QTL mapping is “troublesome since the trait is complex” and frequently “polygenic” with small effect-loci, which is further complicated because “genotype X environment interactions modify pathogen prevalence and severity” across different conditions (pgs. 2-3).
Additionally, Rasool et al. teaches that “false positives are still a serious issue in QTL mapping” and “small-effect QTLs are more difficult to identify, large populations that can also provide extensive genotypic and phenotypic data are needed. Empirical evidence of these challenges emphasizes the importance of using modern statistical tools and modem technology to increase QTL mapping accuracy and efficiency for disease tolerance” (pg. 3, col. 1). This demonstrates that QTL mapping is complex and full of inconsistencies. Lastly, the state of the art does not teach if SEQ ID NO: 47 resulting in tolerance, let alone all the numerous SNP’s disclosed in claims 3, 5 and 14.
(D) The level of one of ordinary skill;
The level of one ordinary skill in the art is high.
(E) The level of predictability in the art
It is unpredictable what sequence structure(s) within the large region of QTL1.2 CU-0006144 (SEQ ID NO: 36) and CU-0001483 (SEQ ID NO: 39) confers CGMMV tolerance. It is unpredictable what sequence structure(s) within the large region of QTL 1.1 located on chromosome 1, within the chromosomal region delimited by CU-0001918 (SEQ ID NO:1) and CU-0006297 (SEQ ID NO:8) confers CGMMV tolerance. It is unpredictable what sequence structure(s) within the large region of QTL5 located on Chromosome 5, within the chromosomal region delimited by CU-00005234 (SEQ ID NO: 54) and CU-0007979 (SEQ ID NO:57) confers CGMMV tolerance. Lastly, it is unpredictable if SEQ ID NO: 47 results in tolerance, let alone all the numerous SNP’s disclosed in claims 3, 5 and 14.
(F) The amount of direction provided by the inventor
The specification does not provide guidance as to what structures would result in a cucumber plant with CGMMV tolerance in claim 1. The specification does not provide guidance if sequence structure(s) within the QTL1.2 CU-0006144 (SEQ ID NO: 36) and CU-0001483 (SEQ ID NO: 39) will confer tolerance. The specification does not provide guidance if sequence structure(s) within the QTL 1.1 located on chromosome 1, within the chromosomal region delimited by CU-0001918 (SEQ ID NO:1) and CU-0006297 (SEQ ID NO:8) will confer tolerance. The specification does not provide guidance if sequence structure(s) within the QTL5 located on Chromosome 5, within the chromosomal region delimited by CU-00005234 (SEQ ID NO: 54) and CU-0007979 (SEQ ID NO:57) will confer tolerance. Lastly, the specification does not provide guidance if SEQ ID NO: 47 resulting in tolerance, let alone all the numerous SNP’s disclosed in claims 3, 5 and 14.
(G) The existence of working examples
Applicant has no working examples of a cucumber plant comprising QTL1.2 in the region CU-0006144 (SEQ ID NO: 36) to CU-0001483 (SEQ ID NO: 39) conferring CGMMV tolerance. Applicant has no working example of a cucumber plant comprising QTL1.2 CU-0006144 (SEQ ID NO: 36) and CU-0001483 (SEQ ID NO: 39), and/or QTL 1.1 located on chromosome 1, within the chromosomal region delimited by CU-0001918 (SEQ ID NO:1) and CU-0006297 (SEQ ID NO:8) and/or QTL5 located on Chromosome 5, within the chromosomal region delimited by CU-00005234 (SEQ ID NO: 54) and CU-0007979 (SEQ ID NO:57) conferring CGMMV tolerance. Lastly, there is no working examples of SEQ ID NO: 47 resulting in tolerance, let alone all the numerous SNP’s disclosed in claims 3, 5 and 14.
(H) The quantity of experimentation needed to make or use the invention
There is not enough guidance or working examples for one skilled in the art to make this cucumber plant comprising QTL1.2 and QTL1.1 and/or QTL5 because the genus of structures encompassed by QTL1.2 is vast. This guidance is important in light of the unpredictably using QTL analysis as taught by Rasool et al. and discussed above.
Given the breadth of the claim, the state of the prior art, the lack of predictability, and the lack of guidance and working examples, notwithstanding a relatively high level of ordinary skill of those in the art, the amount of experimentation required to make the claimed invention would likely be extensive and undue.
Accordingly, weighing all the Wands factors based on the totality of the record as discussed above, the Office determines that it would require undue experimentation for a person of ordinary skill in the art to make and use the invention as claimed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 only requires QTL1.2 and no other QTL that confers tolerance. Because claim 15 also comprises QTL1.1 and/or QTL5, it fails to properly further limit the claim from which it depends because claim 1 does not comprise a QTL other than QTL1.2 to confer tolerance.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1, 4, 6, 8-12 and 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paz et al. (WO 2021/019272).
Instant claims 1, 4, 6, 8-12 and 15-17 are drawn to a Cucumis Sativus plant tolerant to CGMMV comprising in its genome a QTL on chromosome 1, wherein said QTL confers to the plant a tolerance to CGMMV, wherein the said QTL on chromosome 1 is QTL1.2 located within the chromosomal region delimited by CU-0006144 (SEQ ID NO:36) and CU-0001483 (SEQ ID NO:39), wherein QTL1.1 located on chromosome 1, within the chromosomal region delimited by CU- 0001918 (SEQ ID NO:1) and CU-0006297 (SEQ ID NO:8), wherein said QTL1.2 and QTL1.1 conferring tolerance to CGMMV are obtainable from a donor plant having the genetic background of the genome of the seeds of the plant CUC58.4,or in the progeny thereof comprising said QTL, a cell or plant part or seed thereof, a tissue culture of regenerable cells from said plant, a hybrid produced from said plant, a method for detecting plants comprising said QTL wherein the presence of a genetic marker is associated with said QTL, a method for reducing the loss of plant production comprising growing said plant, and use of said plant.
As noted above, the claims define “QTL1.2” by function rather than structure: it is a limitation without a disclosed structure in the specification present in a chromosomal region and which confers the function of tolerance to CGMMV. Thus, any prior art disclosing a QTL on chromosome 1 would be indistinguishable from the plant as claimed, or any art disclosing QTLs in the region as claimed would be indistinguishable from the claimed plant.
Paz et al. claim a Cucumis sativus var. sativus plant tolerant to Tomato leaf curl New Delhi virus (ToLCNDV), comprising in its genome the combination of a first quantitative trait locus (QTL) QTL1 on chromosome 1 and a second QTL, QTL2 on chromosome 2, at least one of QTL1 and QTL2 being homozygous, wherein said combination confers to the plant tolerance to ToLCNDV, wherein said QTL1 is located on chromosome 1 , within the chromosomal region delimited by CU-0002005 (SEQ ID NO:1 ) and CU-0001983 (SEQ ID NO:12), cells and parts and seeds from said plant, tissue cultures from said plants, methods for detecting plants comprising said QTLs or markers associated with said QTLs, and methods of using and breeding said plants (e.g., see claims 1, 7, 8, 9, 10, 11, 12, 18, 19 and 21-23).
Paz et al. also disclose the QTL1 on chromosome 1 may be delineated by SNP CU-0001983 and CU-0002005 (p. 8 beginning at line 5) or between the intervals CU-0002005 and CU-000649 found in deposited variety TOCUR6080 (p. 7, last par. and p. 9 beginning at line 30; see also Example 4 for comparison of Paz et al. to QTL1.2 and QTL1.1 as disclosed on p. 40 of the instant invention) and which overlap with the region as instantly claimed.
Here, the Office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same, material, structural and functional characteristics of the claimed product.
In the absence of evidence to the contrary, the burden is on the Applicant to provide that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation, Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999).
Because Paz et al. disclose a plant comprising the QTLs in the same region as instantly claimed it necessarily follows that said plant will also have tolerance to CGMMV.
Therefore, a Cucumis Sativus plant tolerant to CGMMV comprising in its genome a QTL on chromosome 1, wherein said QTL confers to the plant a tolerance to CGMMV, wherein the said QTL on chromosome 1 is QTL1.2 located within the chromosomal region delimited by CU-0006144 (SEQ ID NO:36) and CU-0001483 (SEQ ID NO:39), wherein QTL1.1 located on chromosome 1, within the chromosomal region delimited by CU- 0001918 (SEQ ID NO:1) and CU-0006297 (SEQ ID NO:8), wherein said QTL1.2 and QTL1.1 conferring tolerance to CGMMV are obtainable from a donor plant having the genetic background of the genome of the seeds of the plant CUC58.4,or in the progeny thereof comprising said QTL, a cell or plant part or seed thereof, a tissue culture of regenerable cells from said plant, a hybrid produced from said plant, a method for detecting plants comprising said QTL wherein the presence of a genetic marker is associated with said QTL, a method for reducing the loss of plant production comprising growing said plant, and use of said plant is anticipated by Paz et al.
Claim(s) 1, 6, 8-12 and 15-17 is/are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Liberti et al. (Pub No. US 2024/0206414 A1).
Instant claims 1, 6, 8-12 and 15-17 are drawn to a Cucumis Sativus plant tolerant to CGMMV comprising in its genome a QTL on chromosome 1, wherein said QTL confers to the plant a tolerance to CGMMV, wherein the said QTL on chromosome 1 is QTL1.2 located within the chromosomal region delimited by CU-0006144 (SEQ ID NO:36) and CU-0001483 (SEQ ID NO:39), wherein said QTL1.2 conferring tolerance to CGMMV is obtainable from a donor plant having the genetic background of the genome of the seeds of the plant CUC58.4, a cell or plant part or seed thereof, a tissue culture of regenerable cells from said plant, a hybrid produced from said plant, a method for detecting plants comprising said QTL wherein the presence of a genetic marker is associated with said QTL, a method for reducing the loss of plant production comprising growing said plant, and use of said plant.
As noted above, the claims define “QTL1.2” by function rather than structure: it is a limitation without a disclosed structure in the specification present in a chromosomal region and which confers the function of tolerance to CGMMV. Thus, any prior art disclosing a QTL on chromosome 1 would be indistinguishable from the plant as claimed, or any art disclosing QTLs in the region as claimed would be indistinguishable from the claimed plant.
Liberti et al. claim a cultivated Cucumis sativus var. sativus plant comprising at least two introgression fragments on chromosome 1, 2 and/or 3 from a wild cucumber donor wherein one of said fragments comprises QTL1.1, or said plant comprises at least three introgression fragments on chromosome 1, 2 and/or 3, wherein each of said introgression fragments comprises a QTL selected from the QTLs designated QTL1.1, QTL1.2, parts, seeds and cells therefrom, and a method identifying said plant (see claims 1, 8, 9, 10 and 11).
Liberti et al. disclose QTL1.2 overlaps in scope with the region as instantly claimed: the introgression fragment comprises QTL1.2 starts at nucleotide (or base) 22942981 of chromosome 1 (corresponding to SNP_17) and ends at nucleotide (or base) 25543032 of chromosome 1 (p. 19, par. 0213).
Liberti et al. disclose the fragment may be introduced into a plant by crossing (par. 0217), and that said fragment may be identified (par. 0301), and that markers associated with said fragment/QTL may be identified (par. 0311 and 0312). Hybrid plants may be produced and tissue cultures are encompassed by the invention (par. 0526; see also par. 0618).
Here, the Office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same, material, structural and functional characteristics of the claimed product.
In the absence of evidence to the contrary, the burden is on the Applicant to provide that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation, Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999).
Because Liberti et al. disclose a plant comprising the QTLs in the same region as instantly claimed it necessarily follows that said plant will also have tolerance to CGMMV.
Therefore, a Cucumis Sativus plant tolerant to CGMMV comprising in its genome a QTL on chromosome 1, wherein said QTL confers to the plant a tolerance to CGMMV, wherein the said QTL on chromosome 1 is QTL1.2 located within the chromosomal region delimited by CU-0006144 (SEQ ID NO:36) and CU-0001483 (SEQ ID NO:39), wherein said QTL1.2 conferring tolerance to CGMMV is obtainable from a donor plant having the genetic background of the genome of the seeds of the plant CUC58.4, a cell or plant part or seed thereof, a tissue culture of regenerable cells from said plant, a hybrid produced from said plant, a method for detecting plants comprising said QTL wherein the presence of a genetic marker is associated with said QTL, a method for reducing the loss of plant production comprising growing said plant, and use of said plant is anticipated by Liberti et al.
Conclusion
No claim is allowed.
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/C.J.O./Examiner, Art Unit 1663
/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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