DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1, 3-5, 7-8, 10-11 and 17-20 are pending.
Claims 17-20 are withdrawn from being examined.
Claim 21 is cancelled by the Applicant.
Claims 1, 3-5, 7-8 and 10-11 are being examined.
Claim Objections
Claim 1 recites “… one to ten or more or more or ten or more of the following plant defense genes is modulated…”. There is a grammatical error. It is suggested to add “/are” after underlined “is”.
Claim Rejections - 35 USC § 112(b)
Claims 1, 3-5, 7-8 and 10-11 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.
Claims 1 and 10-11 recite several genes including “Regulator of gene silencing”. However, the Applicant does not describe or define what the term “Regulator of gene silencing” implies. “Gene Silencing” is a well-known process in the art. Many genes are known to be involved and regulate the process. The Applicant does not define what qualifies as a gene/protein to become a “Regulator of gene silencing”. There is no structure (sequence) of the “Regulator of gene silencing” in the instant description. The specification in Table 1 refers to an accession number as a Regulator of gene silencing, but the instant claims are not so limited.
The Applicant describes two PCR primers (SEQ ID NOs: 27-28) that potentially can align to specific cDNA sequence(s) in the tomato. The primers comprise significant sequence identity to many cDNA sequences in tomato and is expected to give positive results in qPCR, as done by the Applicant, as a standard BLAST search indicates, as shown below. The Applicant is reminded that primers with less than 100% sequence identity with its template also give positive results in PCR, depending on PCR conditions. A standard BLAST search using one of the primers (SEQ ID NO: 27) identifies the following genomic sequences/genes in tomato alone. Several of them have 100% identical sequence with instant SEQ ID NO: 27, as shown below.
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It is suggested to include a structure (sequence) of the specific gene identified as “Regulator of gene silencing” in relevant claims. To provide a better customer service and compact prosecution, the term “regulator of gene silencing” is interpreted by the Examiner as any gene involved in gene silencing in a plant.
Claim Rejections - 35 USC § 112(a)
Written Description
Claims 1, 3-5 and 8 and 10-11 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 claims contain 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.
Claim 1 and all the claims directly or indirectly depending from claim 1 are drawn to a method of increasing resistance to any viral pathogen by modulating gene expression of one or more plant gene(s). The method comprises just one active step of applying laminarin to the plant. The claimed invention is drawn to an extremely large genus.
The working example provided by the Applicant is related to one single plant virus- Tomato Spotted Wilt Virus (TSWV) (Spec, page 26, last para).
The Applicant does not describe increasing tolerance against any plant virus other than TSWV. The Applicant does not describe representative number of species of the broad genus of increased resistance against vast array of plant viral diseases.
The Applicant also does not describe representative numbers of different genes encoding a specific group of proteins like “AP2-like-ethylene-responsive transcription factor” even in tomato that has about 134 AP2/ERF genes, other than Solyc11g072600 (p.6, table 1) while claiming the broad genus of any gene belonging to the large “AP2-like-ethylene-responsive transcription factor” family of genes.
Current status of the art shows that the AP2-like-ethylene-responsive transcription factor proteins (AP2/ERFs) are widespread in the plant kingdom (one of the largest transcription factor families in plants) and involved in the control of primary and secondary metabolism, growth and developmental programs, as well as responses to environmental stimuli (Licausi et al., APETALA2/Ethylene Responsive Factor (AP2/ERF) transcription factors: mediators of stress responses and developmental programs, 2013, New Phytologist, 199: 639–649; abstract; discussed in more detail below). The prior art, including Licausi et al., does not teach that AP2-like-ethylene responsive transcription factor confers resistance to plants against any viral pathogen.
The Applicant also does not describe any structure function relationship with the broad genus of plant viral diseases and specific gene(s) in relation to the 15 genes showing significant difference in expression level after application of laminarin. Many of the 15 genes belong to a family of genes present in many plants and/or having many members of the family, as discussed above for the genes including the ones encoding AP2-like-ethylene-responsive transcription factor proteins (AP2/ERFs).
Considering the breadth of the claims, lack of representative species of the broad genus claimed, lack of structure function relationship of the broad genus claimed in view of working examples, the Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Response to Applicant’s Argument (Regarding rejections under 35 U.S.C. §112(b)): Regarding the terms to describe a gene including “Regulator of gene silencing”, the Applicant “directs the attention of the Office to ¶[0031] of the Specification as published and notes that a full description of the term is provided therein” (response, p.6, para 3, line 1-3). The applicant also argues, “… the paragraph explicitly states inter alia: "The targeted RNAs are degraded or inhibited. In plants the silencing signal is amplified by the activity of host-encoded RNA-dependent RNA polymerases (RDRs) which act for a secondary siRNA production.” (response, para 3, line 3-9).
The Examiner disagrees. The instant specification does not have any paragraph marking/numbering. However, the paragraph 0031 in Pre-Grant publication (pgpub), US20240099214A, also does not describe any structure (sequence) of the “Regulator of gene silencing”. The specification in Table 1 refers to an accession number (AY642285.1) as a Regulator of gene silencing which is a specific gene from tomato. However, the claims, as written, are not limited to a specific gene.
Claim Rejections - 35 USC § 102(a)(1)
Claims 1, 3-5, 7-8 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ménard et al. ((Defense and Resistance-inducing Activities in Tobacco of the Sulfated 8-1,3 glucan PS3 and its Synergistic Activities with the Unsulfated Molecule, 2005, Plant Cell Physiol. 46:1964-1972) in evidence of Knapp et al. (Pathogen profile: Tobacco mosaic virus, not just a single component virus anymore, 2001, Molecular Plant Pathology, 2:117–123).
Ménard et al. teaches that laminarin acts as an elicitor of plant defense responses as applying algal extracts (containing laminarin) on crop plants increased resistance to pests and diseases and that fungal ß-glucans are efficient elicitors of defense responses in different plant species (page 1964, right column, para 1, line 3-8). Ménard et al. describes that laminarin induces ethylene-dependent defense responses in tobacco and Arabidopsis and applying laminarin induces (reads on to modulate or “modulated”) the accumulation of phytoalexins and the expression of a set of PR proteins (page 1964, right column, para 1, line 15-19).
Ménard et al. describes that treatment (reads on “applying”) with only laminarin affects or reduces the number of lesions caused by a plant virus, TMV (abstract; Fig. 3A), implying that laminarin increases resistance to TMV (as recited in claim 4), as virus (TMV) infection rate is quantified by the lesion number (page 1969, left column, para 3, line 12-13). It is known in the art that TMV belongs to genus Tobamovirus (Knapp et al., page 117, Abstract) as recited in claim 3.
Further, the only positively recited method step recited in instant claim 1 is “applying laminarin to said plant”. As discussed above, Menard teaches application of laminarin to a plant. The recitation, “wherein, expression of one or more…. of the following plant defense genes is modulated: …. Pti6” only expresses the intended result of the positively recited step of applying laminarin the plant. See MPEP 2111.04(I).
Regarding claim 5, Ménard et al. teaches that applying (algal extracts comprising) laminarin on crop plants, acts as an elicitor of plant defense responses (page 1964, right column, para 1), as recited in claim 5. “On crop plants” is interpretated to read on the limitation “to a locus of said plants” based on instant specification on page 4, paragraph 4 asserting, “the locus, i.e. habitat, growing ground, plant, seed, soil, area, material or environment in which the plant is growing or may grow” (emphasis added).
Regarding claim 7; claim 7 depends from claim 1 and is drawn to the said at least one plant defense gene is overexpressed or upregulated. Menards et al. describes the positively recited step of applying laminarin and induces, which reads on to “overexpressed” and “upregulated”, a set of PR proteins by laminarin (page 1964, right column, para 1, line 15-19). One of the PR proteins, PR1 protein, is a known gene related to plant defense and used as a molecular marker of plant defense and systemic acquired resistance (SAR) in tobacco (Menards et al., page 1965, left column, para 1, line 3-5; page 1969, left column, para 2, line 2-3).
Regarding claims 8 and 10-11; the further limitations of claim 1, as recited in claims 8 and 10-11, are inherently implied as consequences of the only active step recited in claim 1, i.e., applying laminarin to a plant. The Applicant does not undertake any extra step/process to achieve any of the intended outcome (in terms of up- or down-regulation of specific genes) and/or to “increase tolerance to insect and fungal vectored pathogens, increasing plant disease or pest resistance”, after applying laminarin to the plant. If an ordinarily skilled artisan practices the active step, as recited in claim 1 (and 5), the intended outcome would inherently be achieved in terms of up- or down-regulation of specific genes and/or increased “tolerance to insect and fungal vectored pathogens, increasing plant disease or pest resistance”. See MPEP 2111.04(I).
Claims 1, 3-5 7-8 and 10 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gauthier et al.
Gauthier et al. describes that applying Laminarin (as recited in claims 1 and 5) results in increased (partial) resistance against Tobacco Mosaic Virus (TMV) (page 2, left column, para 4, line 3-5) (as recited in claims 1 and 4), which is known to belong the genus Tobamovirus (as recited in claim 3). Lam elicits defense-related events in tobacco and grapevine (page 2, left column, para 3). Gauthier et al. describes up-regulation of 94 genes by Lam (page 5, left column, para 5, line 15) including Subtilisin-like protease and Hypersensitive-induced response protein (Supplemental Table S2), as recited in claims 1, 7 and 10. Gauthier et al. also describes down-regulation of 4 genes (as recited in claim 8) after Lam application (page 5, left column, para 5, last 2 lines), although none of the genes being downregulated is among the list of 15 genes recited in claim 1.
Response to Applicant’s Argument (Regarding rejections under 35 U.S.C. §102): Applicants argues, “Claim 1 now requires, among other things, modulating expression of one to ten or more plant defense genes, and doing so where the modulation is relative to the genetic profile of a plant exposed to a plant pathogen, wherein the plant pathogen is a virus” (Response, p.7, last para, line 1-4). The Applicants also argues, “Ménard's primary antiviral resistance teaching is not the claimed method using laminarin as now claimed” (response, p.8, para 1, last 2 lines) and “Ménard does not disclose the amended gene-expression comparison required by claim 1 (response, p.8, para 2, first 2 lines). The Applicant continues to argue, “… amended claim 1 is limited to a plant pathogen that is a virus and to gene-expression modulation relative to the genetic profile of a plant exposed to a viral plant pathogen. Gauthier concerns grapevine induced resistance against downy mildew caused by Plasmopara viticola and transcriptomic responses associated with that fungal/oomycete disease context” (response, p.8, last para, line 3-7).
The Examiner disagrees. Modulating expression of specific genes is an inherent consequence of the only active step (i.e., applying laminarin to a plant), as recited in claims 1 and 10. The Applicant does not undertake any extra step/process to achieve any of the intended outcome (in terms of up- or down-regulation of specific genes) and/or “increasing plant viral pathogens resistance”, after applying laminarin to the plant. If an ordinarily skilled artisan practices the same active step, as recited in the claims, the intended outcome would inherently be achieved in terms of up- or down-regulation of specific genes and/or “increasing plant viral pathogens resistance”. See MPEP 2111.04(I).
Ménard et al. specifically describes that treatment with only laminarin (not PS3) affects or reduces the number of lesions caused by a plant virus, TMV (abstract; Fig. 3A), implying that laminarin increases resistance to TMV, as virus (TMV) infection rate is quantified by the lesion number (page 1969, left column, para 3, line 12-13).
Gauthier et al. teaches that laminarin treatment results in partial resistance against TMV and laminarin treatment modulates specific 94 genes (page 5, left column, para 5, line 15) including Subtilisin-like protease and Hypersensitive-induced response protein (Supplemental Table S2), as recited in claims 1 and 10. Gauthier et al. also describes down-regulation of 4 genes after Lam application (page 5, left column, para 5, last 2 lines), although none of the genes being downregulated is among the list of 15 genes recited in claim 1. All these modulations of expressions of specific genes are inherent consequences of the applying laminarin to a plant without any active step/process undertaken by an ordinarily skilled artisan to achieve “increasing plant viral pathogens resistance”. Both Menard et al. and Gauthier et al. teach treating plants with laminarin, and that the treated plans have increased plant viral pathogen resistance. That expression of plant defense genes, including those recited in the claims, are modulated in the treated plants, is a result of the laminarin treatment.
Conclusion
All the claims remain rejected.
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.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
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J.C.
/Jay Chatterjee/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
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