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 .
DETAILED ACTION
1. The Office acknowledges the receipt of Applicant’s amendment filed June 18, 2025 and substitute Specification filed October 6, 2025. Claims 1, 5, 8-16 and 22 are pending. Claims 5, 9 and 22 are withdrawn from examination. Claims 1, 8 and 10-16 are examined in the instant application.
All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is made FINAL.
Claim Rejections - 35 USC § 112(b)
2. Claims 1, 8 and 10-16 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 pre-AIA the Applicant regards as the invention.
In claim 1, there is no correlation between the duplication of a region of chromosome 3 and the increased resistance against internal fruit rot symptoms. Does Applicant intend for the duplication of a region of chromosome 3 to confer the increased resistance? In line 2, it is suggested “and an increased resistance” be amended to “that confers increased resistance” to indicate a correlation between the duplication and the increase resistance.
In claim 1, it is unclear whether the duplication is from the genome of the claimed plant or from another plant’s genome. Where is the duplication from? Additionally, are SEQ ID Nos. 83 and 84 genomic sequences of the claimed plant, or are they from a donor source?
In claim 1, it is unclear whether the duplication contains two copies of SEQ ID NO:83 and two copies of SEQ ID NO:84, or only one copy of each SEQ ID NO. What is being duplicated?
In claim 8, it is unclear how “a wild cucumber” structurally differs from one that is not wild. It is unclear how one skilled in the art can objectively distinguish a wild cucumber from other cucumbers.
In claim 16, “a plant according to claim 1” should be amended to “the plant according to claim 1” for proper antecedence.
Dependent claims are included.
Clarification and/or correction is required.
Double Patenting
3. Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 of copending Application No. 18/965676 (hereafter ‘676). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed plant obtained from the seeds of deposit NCIMB 43530 contain both a duplication of QTL3.1 and QTL5.1 (p. 1, lns. 28-30 of the instant application and p. 2, lns. 3-5 of ‘676), and is therefore identical to the claimed plant of ‘676 obtained from the seeds of deposit NCIMB 43530.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s Traversals
Applicant traverses primarily that the ‘676 application is a divisional of the instant application and the claims of the ‘676 application and the instant application are not directed to seeds of deposit NCIMB 43530 per se.
Response to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. Even though the ‘676 application is a divisional of the instant application, the claimed plants in both applications are obtained from the same deposited seeds and thus are identical to each other. The plant containing the duplication on chromosome 3 of the instant application is obtained from NCIMB 43530. The plant containing QTL5.1 on chromosome 5 of ‘676 is also obtained from NCIMB 43530. There is no structural difference between the plant containing the duplication on chromosome 3 grown from the seeds deposited at NCIMB 43530 and the plant containing QTL5.1 on chromosome 5 of ‘676 grown from the seeds deposited at NCIMB 43530. Accordingly, the rejection is maintained.
Claim Rejections - 35 USC § 112(a)
4. Claims 1, 8 and 11-16 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claim 1, there is no disclosure as to the structure of the duplication of a region of chromosome 3 for conferring increased resistance against internal fruit rot caused by Didymella bryoniae. The art does not recognize a particular structure that can be correlated to resistance to internal fruit rot caused by D. bryoniae. Claim 1 merely indicates that the duplication is flanked by and comprises SEQ ID Nos. 83 and 84. However, there is no evidence that SEQ ID Nos. 83 and 84 confer disease resistance by flanking any duplication of a region of chromosome 3 from any source. Example 2 discloses that the resistance was obtained from wild cucumber donor MYCR3 and the QTL of the donor responsible for internal fruit rot resistance is a duplication of QTL 3.1, i.e., SEQ ID NO:72. Wild cucumber donor MYCR3 and the QTL 3.1 duplication are not representative of other donor sources or of duplications of any length from any region of chromosome 3.
Claim 8 lacks adequate written description because it does not recite the structure of the duplication of the introgressed sequence and the wild cucumber donor source. Moreover, “wild” is not adequate defined, and there is no evidence that all “wild” cucumber sources contain the duplication for conferring D. bryoniae resistance. The recitation of “induced by targeted genome modification, or is introduced by transformation” lacks adequate written description because no sequence is recited for said targeted genome modification or for said transformation.
Claims 11-16 do not address any of the written description issues set forth for claim 1.
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 2008 online at http://www.uspto.gov/web/menu/written.pdf.
Applicant’s Traversals
Applicant traverses that the claims have been amended to remove the 95% sequence identity language.
Response to Applicant’s Traversals
Applicant’s traversal is unpersuasive because the claim amendments raise new written description issues as set forth above. Accordingly, the rejection is maintained.
Claim Rejections - 35 USC § 102 or 35 USC § 103
5. Claims 1, 8 and 10-16 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Haaring et al. (WO 2019016323, hereafter “WO323”, (Third Party Submission IDS)) in light of Haaring et al. (US Pub. No. 20240065191, hereafter “Haaring ‘191”, (Third Party Submission IDS)).
WO323 teaches a C. sativus (cucumber) plant comprising a region of approximately 30 genes in the QTL on chromosome 3 present in duplicate (copy number variant (CNV)) which leads to resistance against pathogen Pythium (p. 3, lns. 5-13). The duplication region is flanked by SEQ ID NO:4 and SEQ ID NO:5 (claim 2). The duplication can be introduced by introgression from a donor plant (p. 17, lns. 26-35), by transformation or by targeted genome modification (p. 11, lns. 22-30). WO323 further teaches homozygous markers, and a flanking marker having SEQ ID NO:4 which has 100% sequence identity to Applicant’s flanking marker having SEQ ID NO:83. (Fig. 2). Deposited seeds under accession number NCIMB 42776 have Pythium resistance, are homozygous and comprise the QTL, the duplication region and at least two copies of an ERF (ethylene responsive transcription factor) gene (p. 16, lns. 18-22; p. 18, lns. 25-27). WO323 additionally teaches Marketmore 70, which is a slicing cucumber (p. 7, ln. 21). The plant can be an F1 hybrid or an inbred line (p. 10, ln. 1, claim 13). WO323 discloses seed and fruit (p. 1, ln. 7). Even though WO323 does not specifically teaches seedless fruits, WO323 teaches cucumbers with different backgrounds that could be further used in different combinations for the development of C. sativus varieties of different types, which would include seedless varieties (p. 2, lns.15-16).
WO323 does not teach Didymella bryoniae resistance.
Haaring ‘191 teaches the presence of the same duplication (CNV) region that leads to Pythium resistance also leads to increased internal fruit rot resistance caused by D. bryoniae (D. brioniae), and both resistance phenotypes are present in the deposited seed under NCIMB 42776 [0029]. Thus, the seeds deposited under NCIMB 42776 of WO323, and plant obtained therefrom, inherently has resistance to D. bryoniae. With regard to claim 10, because NCIMB 42776 of WO323 has resistance to D. bryoniae from the QTL present in chromosome 3, the flanking marker SEQ ID NO:4 of WO323 has 100% sequence identity to Applicant’s flanking marker SEQ ID NO:83, and Applicant identifies the region of the donor responsible for internal fruit rot resistance is SEQ ID NO:72, the plant of WO323 inherently has the duplication region present in Applicant’s NCIMB 43530 deposit, absent evidence to the contrary. Even though flanking marker SEQ ID NO:84 is not taught in WO323, it would appear that the deposit of WO323 inherently contains a flanking marker that is the same as Applicant’s SEQ ID NO:84, because the deposit of WO323 contains the QTL on chromosome 3 for D. bryoniae resistance, and the QTL spans a region from position 8423638 (SEQ ID NO:1) to position 10261179 (SEQ ID NO:2) with duplication of the ERF genes for conferring disease resistance (Fig. 2). Moreover, it should be noted that flanking markers are just that—markers that indicate the presence of the sequence of interest and do not provide an unexpected and practically significant difference to the sequence of interest.
Legal precedent provides that “mere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not distinguish a claim drawn to those things from the prior art.” In re Oelrich, 666 F.2d 578, 581 (C.C.P.A. 1981). Thus, the mere recitation of a newly discovered property, which in this case is D. bryoniae resistance, inherently possessed by the deposit in prior art WO323, does not distinguish a claim drawn to the inherent D. bryoniae resistance property of the prior art. The Supreme Court explained long ago that “[i]t is not invention to perceive that the product which others had discovered had qualities they failed to detect.” Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 249 (1945).
Accordingly, the claimed invention is anticipated by, or in the alternative, is obvious in view of the prior art. See In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985), which teaches that a product-by-process claim may be properly rejected over prior art teaching the same product produced by a different process, if the process of making the product fails to distinguish the two products. Since the Patent Office does not have the facilities to examine and compare the plant of Applicant’s with that of the prior art, the burden of proof is upon the Applicant to show an unobvious distinction between the claimed plant and the plant of the prior art. See In re Best, 562F.2d 1252, 195 USPQ 430 (CCPA 1977).
Applicant’s Traversals
Applicant traverses primarily that (1) Exhibit B shows that the CNV of Haaring ‘191 is 6 nucleotides shorter than the CNV of the instant application because it starts at nucleotide 9138860, whereas the CNV of the instant application starts at nucleotide 9138854; and (2) Haaring ‘191 describes there are 7 polymorphisms between COPY 1 and COPY 2 (SEQ ID Nos. 6-9 and SEQ ID Nos. 14-16), while COPY 1 and COPY 2 of the CNV present in the instant plants are not polymorphic for 4 of the polymorphisms described by Haaring ‘191.
Response to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. With regard to traversal (1), Applicant is arguing limitations not present in the claims. The claims do not recite the structure of “a duplication of a region of chromosome 3” for conferring increased resistance against internal fruit rot. No size for the duplication is recited. With regard to traversal (2), this is a 35 USC 102/103 rejection. Polymorphisms that do not alter the plant phenotype are ubiquitous in all plants. The polymorphisms present in the Haaring ‘191 donor source do not alter its phenotype, i.e., increased resistance against internal fruit rot symptoms caused by D. bryoniae. If there are differences between the claimed invention and the prior art, there is no evidence that these differences, e.g., polymorphisms, provide an unexpected and practically significant difference to the sequence of interest. Accordingly, the claimed invention is anticipated by, or in the alternative, is obvious in view of the prior art.
Conclusion
6. No claim is allowed.
7. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached on M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHUONG T BUI/Primary Examiner, Art Unit 1663
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