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 .
Status of Claims
Claims 1 and 5-20 are pending.
Claims 9-14 remain withdrawn for being directed to a non-elected invention(s).
Claims 2-4 have been cancelled.
Claims 16-20 have been newly added.
Claims 1, 5-7, 9-10, and 15 have been amended.
Claims 1, 5-8 and 15-20 are examined in this Office action.
Information Disclosure Statement
Initialed and dated copy of Applicant’s information disclosure statement (IDS) filed on
06/26/2026 is attached to the instant Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objections/Rejections that are Withdrawn
The objection to the Specification has been withdrawn in light of Applicant’s amendment to the Specification.
All rejections to claims 2-4 have been rendered moot by Applicant’s cancelation of the claims.
The objection to claim 7 has been withdrawn in light of Applicant’s amendment to the claim. However, the objection to claim 1 is maintained.
The 35 USC 112(b) Indefiniteness rejection to claims 1, 5, 6, and 15 has been withdrawn in light of Applicant’s amendment to the claims.
The 35 USC 112(a) Written Description rejection to claims 1, 7-8, and 15 for the recitation of “all PUB17 proteins” and “any ortholog or homolog of instant sequence SEQ ID NO: 1” has been withdrawn in light of Applicant’s amendment to the claims. However, the claims remain rejected for unresolved 35 USC 112(a) Written Description issues.
The 35 USC 102/103 rejection to claims 1, 2, 7, 8, and 15 has been withdrawn in light of Applicant’s amendment to the claims.
The 35 USC 103 rejection to claims 3- 6 has been withdrawn in light of Applicant’s amendment to the claims.
The text of those sections of Title 35, U.S. Code, not included in this action, can be found in a prior Office action.
Claim Objections
Claim 1 is objected to because of the following informalities: the full name of the PUB17 protein should be written out the first time it is used in a claim. Applicant states that “PUB17” is the full name of the protein, and is not an abbreviation (see Remarks dated 06/26/2026, page 7). However, YANG (Yang et al., 2006, The Plant Cell, Vol. 18(4), pp. 1084-1098; see IDS dated 10/01/2024) discloses Arabidopsis thaliana PUB17 as Arabidopsis thaliana PLANT U-BOX17 (Yang, Abstract).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Written Description
Claims 1, 5-8, and 15-20 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim. This is a modified rejection based on the claim amendments.
Claim 1 recites “[a] tomato plant or plant material having reduced level, activity, or expression of a Pub 17 protein conferring an increased resistance to a lesion-forming pathogen relative to a reference tomato plant or plant material; wherein the tomato plant or plant material comprises a modified Pub17 allele, wherein the modified Pub17 allele comprises at least 70% identity with the wild type Pub17 allele SEQ ID NO:1, and wherein the modified Pub17 allele comprises a mutation from SEQ ID NO: 1”.
Applicant has claimed an extremely large genus of all lesion-forming pathogens. The instant Specification states that the lesion-forming pathogen is a fungus, virus, or oomycete, which encompasses numerous species from several genera as listed on pages 35-36. It is noted that at the time of filing the Applicant had reduced to practice the reduced expression of the PUB17 protein of Solanum lycopersicum (instant sequence SEQ ID NO: 3 which is encoded by instant sequence SEQ ID NO: 1), which conferred resistance to the lesion-forming pathogens Botrytis cinerea and Alternaria solani. The instant Specification does not disclose the SlPUB17 allele (instant sequence SEQ ID NO: 1) increasing resistance to any lesion-forming pathogens other than Botrytis cinerea and Alternaria solani. A Written Description rejection is based on what the Applicant was in possession of at the time of filing. Applicant tested one PUB17 allele, SlPUB17 (instant sequence SEQ ID NO: 1), which when expression is reduced, increased resistance to Botrytis cinerea and Alternaria solani.
Additionally, claim 1 recites “wherein the modified Pub17 allele comprises at least 70% identity with the wild type Pub17 allele SEQ ID NO:1”. Instant sequence SEQ ID NO: 1 consists of 2175 nucleotides. Altering up to 30% of those nucleotides would allow for 652 substitutions, and therefore the genus of nucleotides encompassed by this is 4652 . Claim 1 encompasses an extremely large genus of molecules, and the Applicant was only in possession of one (modified PUB17 allele, instant sequence SEQ ID NO: 2) which was reduced to practice. Applicant has described one sequence, instant sequence SEQ ID NO: 2, which shares 99.9% sequence identity with instant sequence SEQ ID NO: 1, capable of increasing resistance to the lesion-forming pathogens Botrytis cinerea and Alternaria solani.
The Specification does not provide any description of the domains or motifs within SEQ ID NO: 1 that are required for lesion-forming pathogen resistance, therefore, there is no structure/function analysis provided. Applicants have identified a mutation, an A→T SNP at position 1477 of the coding region of the SlPUB17 allele (instant sequence SEQ ID NO: 2), which results in a premature stop codon R493*, eliminating Armadillo (ARM) repeats 2-4 (Specification, page 51, lines 35-36; Figure 16). Additionally, Applicants silenced PUB17 by introducing RNAi3 which targeted the U-BOX domain and RNAi7 which targeted the UND domain (Specification, page 57, lines 16-20; Figure 4). Applicant further introduced mutations into PUB17 via CRISPR/Cas9 using 4 sgRNAs. The mutant alleles all contained an intact UND domain and U-BOX domain; mutant alleles 1-3 contained the first ARM repeat with the second ARM repeat truncated and ARM repeats 3-4 entirely deleted; mutant allele 4 lost the first three ARM repeats but retained ARM4 (Specification, pages 61-62, lines 25-26 and 3-6; Figure 16). Each of these variations of mutations showed an increased resistance to B. cinera or A. solani.
Given that there have not been an adequate number of species reduced to practice to be representative of the broad genus of all modified Pub17 alleles comprising at least 70% identity with SEQ ID NO:1 (wild type Pub17 allele) and all lesion-forming pathogens, and there is no description of structures that are correlated with the required function, there is not an adequate description to support the breadth of the claim.
Response to Applicant Arguments
Applicant's arguments filed 06/26/2026 have been fully considered but they are not persuasive.
Applicant argues that “possession may be shown in a variety of ways” (MPEP 2163.I) and “reduction to practice is not required for compliance with 112(a)”.
The Examiner respectfully disagrees. A Written Description rejection is based on what the Applicant was in possession of at the time of filing. The Applicant has not supported the assertion of a modified Pub17 allele comprising less than 99.9% sequence identity with SEQ ID NO:1 (wild type Pub17 allele) conferring resistance to a lesion-forming pathogen other than Botrytis cinerea and/or Alternaria solani. The instant Specification does not provide any description of the genus of Pub17 alleles comprising at least 70% identity to SEQ ID NO: 1 that are capable of conferring resistance to any lesion-forming pathogen, nor does the Specification provide a description of the domains or motifs within SEQ ID NO: 1 that are required for lesion-forming pathogen resistance. Thus, Applicant has not shown possession of a modified PUB17 allele comprising less than 99.9% sequence identity with SEQ ID NO:1 (wild type Pub17 allele) conferring resistance to a lesion-forming pathogen other than Botrytis cinerea and Alternaria solani.
Applicant is claiming a broad-spectrum resistance to all lesion-forming pathogens when the level, activity, or expression of a PUB17 protein is reduced. However, it is known in the art that PUB17 is well established as a positive regulator of plant innate immunity. For example, YANG describes that silencing tomato ACRE276 (a homolog of Arabidopsis thaliana PUB17) leads to a breakdown in resistance against Cladosporium fulvum leaf mold (a lesion forming pathogen) (Yang et al., 2006, The Plant Cell, Vol. 18(4), pages 1084-1098; included on IDS dated 10/01/2024; see Abstract). YANG further describes Arabidopsis PUB17-knockout mutants that conferred compromised resistance to avirulent Pseudomonas syringae pv. Tomato (a lesion-forming pathogen) (Yang, page 1092, left column, last paragraph). Additionally, HE describes silencing StPUB17 in potato by RNAi and NbPUB17 in Nicotiana benthamiana by virus-induced gene silencing (VIGS) each enhanced Phytophthora infestans (a lesion-forming pathogen) leaf colonization (He et al., 2015, Journal of Experimental Botany, Vol. 66(11), pages 3189-3199; included on IDS dated 10/01/2024; see Abstract). The instant Specification supports a modified PUB17 allele comprising 99.9% sequence identity with SEQ ID NO:1 (wild type Pub17 allele) conferring resistance to a lesion-forming pathogens Botrytis cinerea and Alternaria solani. There is not support in the instant Specification or in the prior art of any PUB17 gene having a broad-spectrum resistance to all lesion-forming pathogens when the level, activity, or expression of the protein is reduced.
Summary
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MEADOWS whose telephone number is (703)756-1430. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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CHRISTINA MEADOWS
Examiner
Art Unit 1663
/CHRISTINA L MEADOWS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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