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 .
Application Status
This action is written in response to applicant’s correspondence received 09/10/2025. Claims 1-2, 6, 9-10, 12, 18-19, 23, 31, 37-38, 41 and 49 are currently pending. Applicant elected miR-173, a CRISPR-endonuclease and a nematode without traverse in the reply filed 02/04/2025.
Any rejection or objection not reiterated herein has been overcome by amendment. Applicant' s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
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 1-2, 6, 9-10, 12, 18-19, 23, 31, 37-38, 41 and 49 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.
MPEP 2163.II.A.3.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163 states the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
What the claims encompass/claim interpretation:
Claim 1 encompasses methods of producing a long dsRNA molecule in a plant cell of any plant species, in any plant cell or tissue, in any condition, at any developmental stage, that is capable of silencing any gene in any pest of any species or development stage. The method of claim 1 comprises selecting in a genome of a plant a nucleic acid sequence encoding any silencing molecule having any plant gene as a target (as long as the silencing molecule is capable of recruiting RNA-dependent RNA polymerase), and modifying a nucleic acid sequence of the target plant gene to impart a silencing specificity towards the pest gene, i.e., redirect the targeting functionality of the target plant gene.
Claim 18 encompasses methods of producing long dsRNAs in any plant cell of any plant species, in any cell or tissue, in any condition, at any developmental stage, that is capable of silencing any pest gene of any species or developmental stage. The method of claim 18 comprises selecting any plant gene exhibiting any predetermined homology to any pest gene and modifying any plant endogenous RNA silencing molecule so as to impart silencing specificity towards said homologous plant gene, i.e. redirecting the targeting of the endogenous RNA silencing molecule.
In effect, these methods appear to leverage endogenous gene silencing pathways in plants, specifically secondary siRNA biogenesis, by modifying and redirecting targeting specificity of endogenous plant genes such that they produce dsRNAs and siRNAs targeting pest genes instead. Fei (Fei et al. “Phased, Secondary, Small Interfering RNAs in Posttranscriptional Regulatory Networks”. The Plant Cell, Volume 25, Issue 7, July 2013, Pages 2400–2415. DOI: 10.1105/tpc.113.114652.; see attached PTO-892) reviews these secondary siRNA biogenesis pathways, stating:
Plant genomes are the source of large numbers of small RNAs, generated via a variety of genetically separable pathways. Several of these pathways converge in the production of phased, secondary, small interfering RNAs (phasiRNAs), originally designated as trans-acting small interfering RNAs or tasiRNAs. (abstract)
TasiRNA are a class of secondary siRNAs generated from noncoding TAS transcripts by miRNA triggers in a phased pattern (p. 2401, bottom left)
A first step in secondary siRNA biogenesis, mRNA targets are cleaved by a miRNA…activity of the trigger miRNA recruits RDR6 and SGS3, resulting in production of a second strand of the target mRNA…the dsRNA is successively processed…to generate 21-nucleotide tasiRNAs…the secondary siRNAs are loaded onto an AGO protein and go on to function against other mRNAs (Figure 1)
The Examiner’s understanding of the methods appears to be supported by FIGs. 1 and 2 of the instant specification. These figures outline “GEiGS” pathway models 1 and 2. In one embodiment of model 1, which is broadly described in claim 18, an endogenous plant gene is selected which is not normally a target of a plant miRNA and which has some homology to a target pest gene, but is not modified. Instead, an endogenous plant miRNA targeting some other plant gene is redirected to the homologous plant gene. Via the pathways described above, this would produce a dsRNA and subsequently secondary siRNAs capable of silencing the pest gene. In one embodiment of model 2, the scheme is reversed, such that an endogenous noncoding plant gene which is already a target of an endogenous miRNA, such as a TAS locus, is modified so that the interactions between it and its corresponding miRNA produce siRNAs specific to the pest gene. It is assumed that, in either case, and barring evidence to the contrary, one outcome of this redirection would be some degree of disruption of the endogenous pathways.
The dependent claims limit the RNA silencing molecule to the elected species of a miRNA which is optionally miR-173 (claim 2), the plant gene to a non-protein coding gene and/or one encoding a molecule with intrinsic silencing activity towards a native plant gene (claim 6) which is a phased secondary siRNA-producing molecule (claim 10), the method to one comprising gene editing using a DNA editing agent which is the elected species of CRISPR/Cas9 (claims 8, 23, 31), and describe methods of determining silencing specificity (claims 12, 23). For claim 18, claim 19 limits the predetermined sequence homology, but does not define the length of the sequences which must be homologous, and the specification provides an indefinite range of 20 to 10,000 or more nucleotides (p. 31). It is also unclear which 25% of the plant gene sequence may differ from the target and still provide the required functionality.
The claims encompass the modification of nearly any RNA molecule and nearly any plant gene to silence any gene in any pest at any developmental stage, which is a nearly infinite genus of target organisms and genes. This requires an equally broad genus of modifications. However, the specification does not disclose a sufficient description of a representative number of species by actual reduction to practice or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, sufficient to show the applicant was in possession of the claimed genus of the method as applied to all encompassed plants, pests and genes.
What the specification discloses:
The specification provides exemplary pest genes which may be targeted by the claimed methods, as well as suggested RNAi precursors to be targeted (Tables 1A, 1B, 2). The pests consist of nematodes (H. glycines, C. elegans, M. chitwoodi), flies (B. tabaci, Diptera species A. gambiae), beetles (Coleoptera species D. virgifera), and moths and butterflies (Helicoverpa species H. armigera, Lepidoptera species C. infuscatellus, P. xylostella, S. exigua). This is a much smaller number of pest species than those encompassed by the claims. Additionally, the examples provided appear to be primarily prophetic, with some exceptions.
Example 3 (pp. 125-130) discloses the modification of plant genes TAS1b and TAS3a in A. thaliana protoplasts, which is an embodiment of the method of claim 1. This modification redirected the two genes to target and silence the four genes in G. rostochiensis listed in Table 3 (p. 126; SEQ ID NOs: 55-58), using the siRNA target sites represented by SEQ ID NOs: 59-62 (id.). Example 4 describes the confirmation that the modified TAS genes resulted in modified dsRNA (p. 130-131). However, the silencing specificity of these modified TAS genes in G. rostochiensis was not confirmed, nor was the method performed for any other pest species.
Example 6 (p. 135-137) appears to be the closest working example to the method of claim 1, and the most extensive. This example demonstrates in more detail that silencing dsRNA molecules expressed from a modified N. benthamiana TAS3a gene induced silencing of two specific target genes in the nematode G. rostochiensis. However, this was performed only in the plant species, wherein the modified N. benthamiana gene was TAS3a and the target genes were the Ribosomal protein 3a and Spliceosomal SR protein genes in the nematode. The modified TAS3a gene was expressed from a vector (p. 135, ln. 18-19). The nematodes were fed total RNA from the plant, and qRT-PCR showed that expression of the target genes was reduced (p. 136). However, it is relevant to note that this method was performed using an expression vector to express the modified genes, not via introducing into the plant cell a DNA editing agent, as required by claims 8 and 31. Given the complex regulatory roles played by TAS genes in plants, and the high degree of variability and unpredictability in those genes and their roles for the scope of all claimed plants, it is unclear what effect permanent redirection of TAS3a might have on plant development and growth.
Regarding the required sequence homology to practice the method of claim 18, where a plant gene is selected based on its homology to a pest gene, while claim 19 limits the homology to 75-100% identity, as noted above, it does not limit the length of the homologous sequences. This would theoretically encompass regions of identity anywhere from a 4 nucleotides (to permit an at least 75% identity) to the entire plant and/or pest gene, and it is unclear which lengths would be required.
In summary, the teachings provided by the specification are extremely narrow compared to the breadth of the claims. In addition, as discussed below, the state of the art demonstrates that there is a high degree of variability and unpredictability within the claimed genera.
What the art teaches:
The state of the art shows that there is a high degree of variability and unpredictability throughout the full scope of claimed plants, plant genes, and pests, particularly as it pertains to the siRNA biogenesis pathways modified by the claimed methods.
Regarding plants and plant genes: the methods encompass any plant species in any condition at any developmental stage. It is relevant to note that the methods require selection of plant RNA molecules in genes. Logically, to select a gene for modification, such as via gene editing, the artisan must first know its sequence. The more gene sequences in a plant species that are known, the higher the chances that the artisan will be able to find an appropriate sequence for modification. Thus, at least a partially sequenced genome would realistically be needed.
In 2014, Pimm (Pimm et al. “The biodiversity of species and their rates of extinction, distribution, and protection”. Science344,1246752(2014). DOI:10.1126/science.1246752.; see attached PTO-892) estimated that there are approximately 400,000 species of known land plants, not accounting for those which are yet to be discovered (p. 1246752-1, middle column, top). Thus, the claims encompass an enormous number of phenotypically and genetically diverse plant species. As discussed by Myriakidou (Myriakidou et al. “Current Strategies of Polyploid Plant Genome Sequence Assembly”. Front Plant Sci. 2018 Nov 21; 9:1660. doi: 10.3389/fpls.2018.01660.; see attached PTO-892), it is estimated that around 80% of all living plants are polyploids (p. 2, top left), and through May 2018, only 47 plant polyploid genomes had been sequenced (Table 1). Myriakidou further goes on to discuss some of the challenges facing plant genome assembly, such as repeat content, transposable elements and high heterozygosity, as well as the additional challenges facing polyploid genome assembly, such as increased genome complexity, whole genome duplication events, atypical recombination, intron expansions, etc. (p. 5). From this, it may be concluded that only a very small fraction of the world’s many plant species have published genomes suitable for practicing the claimed method, and sequencing the genomes of the remaining plants would be significantly challenging. This does not take into account the many possible plant developmental stages encompassed by the claims, in which gene expression may vary and modification of any gene in the full scope of genes may have different and unpredictable effects.
Regarding the pests and pest genes: plant pests are interpreted to encompass insect, fungal and microbial pests. Stork (“How Many Species of Insects and Other Terrestrial Arthropods Are There on Earth?”. Annu.Rev.Entomol. 2018. 63:31–45. First published September 22, 2017. DOI: 10.1146/annurev-ento-020117043348.; see attached PTO-892) describes the diversity and number of phytophagous insects, summarizing, in Table 2, the estimates for the numbers of terrestrial species in different regions based on the distribution of their plant hosts. In total, Stork estimates that there approximately 13,000,000 insect species, of which only about 1,013,825 are known (p. 33, middle). Even if it is assumed that not all of the predicted species are plant pests, based on common sense and sound scientific reasoning, Stork’s disclosures would likely lead the skilled artisan would predict that the plant pests encompassed by the claims would nonetheless number in the millions. Of those, many would be unknown, and thus would lack sequenced genes and/or genomes with which to practice the claimed methods.
The art also indicates that there is a high degree of unpredictability in the response of plant pests to dsRNA treatment via transgenic host plants. Bally (Bally et al. “Improved insect-proofing: expressing double-stranded RNA in chloroplasts”. 27 January 2018. Pest. Manag. Sci, 74: 1751-1758.; see attached PTO-892) teaches trans-kingdom RNAi (TK-RNAi), which is, “the production of dsRNA in a plant affecting the viability of an insect” (p. 1751, left). However, Bally points out that, as of January 2018 there was still a high level of unpredictability and variability in the field related to the diversity of insect species:
transforming plants with an RNAi construct targeting an insect gene could protect the plant against feeding by that insect. Production of double-stranded RNA (dsRNA) in a plant to affect the viability of a herbivorous animal is termed trans-kingdom RNAi (TK-RNAi). Since this pioneering work, there have been many further examples of successful TK-RNAi, but also reports of failed attempts and unrepeatable experiments. (abstract)
There have been many additional examples of insects being stunted or killed by RNAi and TK-RNAi, but not all insect species respond equally, nor do the results always appear repeatable. (p. 1751, bottom left)
The most common TK-RNAi approach has been making stable transgenic plants that express hpRNA-containing sequences, as complementary “arms”, derived from essential insect genes… Unfortunately, the conformation and amount of dsRNA that reaches the cells lining the gut of an insect feeding on a transgenic plant expressing hpRNA are less measurable and predictable than with artificial diet or injection assays.
The majority of agronomically important insects, particularly for row crops, fall within the orders of Lepidoptera, Coleoptera, and Hemiptera. They each possess the RNAi hallmark genes Dcr-2 and AGO2, and both lepidopteran and coleopteran cells appear able to take up dsRNA, but these three orders have stark differences in their capacity for gene suppression by eRNAi.
It is relevant to note that the claims encompass any plant pest, including fungi, microbes, etc., while Bally only discusses the unpredictable responses to dsRNA/RNAi among insects within the orders Lepidoptera, Coleoptera, and Hemiptera, which is a much smaller genus of pests than what is claimed. If the art evidences significant variability and unpredictability within this smaller genus, it follows that the unpredictability and variability would be more significant throughout the larger genus.
Regarding plant genes: The claims also encompass any plant genes, either for direct modification and redirection or their homology to a target pest gene. Even if the plant genes were to solely encompass non-coding RNA sequences involved in the secondary siRNA biogenesis pathways discussed above, such as TAS loci, there remains a high degree of unpredictability and variability within that narrower scope of plant genes. For example, the state of the art reflects that the potential effects of editing endogenous TAS3a are unpredictable, but, if we assume that redirecting these loci would to some degree impair their endogenous function, then that redirection is likely to cause some type of developmental defect. As disclosed by Ju (Ju et al. “A Viral Satellite DNA Vector (TYLCCNV) for Functional Analysis of miRNAs and siRNAs in Plants”. Plant Physiol. 2017 Feb 22;173(4):1940–1952. doi: 10.1104/pp.16.01489.; see attached PTO-892), tasiRNAs synthesized from TAS transcripts play vital roles in leaf morphology, lateral root growth, and regulation of ARF, and tasiRNAs from TAS3 can target ARF3 and ARF4 (p. 1941, top left). This role can vary from species to species. For example, Marin (Marin et al. “miR390, Arabidopsis TAS3 tasiRNAs, and Their AUXIN RESPONSE FACTOR Targets Define an Autoregulatory Network Quantitatively Regulating Lateral Root Growth”. The Plant Cell, Volume 22, Issue 4, April 2010, Pages 1104–1117. DOI: 10.1105/tpc.109.072553.; see attached PTO-892) demonstrated that, in A. thaliana, miR390 triggers biogenesis of TAS3 tasiRNA, which itself inhibits ARF2, ARF3, and ARF4, thus releasing repression of lateral root growth (abstract). Marin also discloses that miR390 and TAS3 tasiRNAs define a pathway that regulates leaf patterning and developmental timing by repressing the ARF family members ARF2, ARF3, and ARF4 (p. 1105, top left). Marin further discloses that in leaves, tasiARFs posttranscriptionally regulate the abundance of ARF3 and ARF4, which are transcription factors that promote the expression of adult traits and consequently control the entry into the adult phase…mutations that impair tasiARFs production accelerate this transition, and adult leaves are produced earlier, and in roots, mutations that impair tasiARFs production cause an overaccumulation of young lateral root primordia (p. 1113, top left). Therefore, what Marin shows is that TAS3 plays a crucial role in root and leaf development, and that impairment of TAS3 would cause premature entry into the adult phase and overaccumulation of young lateral root primordia, potentially negatively affecting plant growth and reproduction. Given all of the above, one having ordinary skill would conclude that TAS3 inhibition through gene editing of TAS3 to redirect its silencing activity is unpredictable but may result in negative consequences for plant development.
Marin’s disclosures primarily address A. thaliana. Dotto (Dotto et al. “Genome-Wide Analysis of leafbladeless1-Regulated and Phased Small RNAs Underscores the Importance of the TAS3 ta-siRNA Pathway to Maize Development”. PLOS Genetics. Volume 10, Issue 12. (2014). DOI: 10.1371/journal.pgen.1004826.; see attached PTO-892) discloses some of the interspecies variability in TAS loci and their targets. Dotto discloses that tasiR-ARFs are the major functional ta-siRNAs in the maize vegetative apex where they regulate expression of auxin response factor 3. Dotto also discloses that plants expressing a tasiR-ARF insensitive arf3a transgene recapitulate the phenotype of IbI1 mutants, which show severe developmental defects (abstract). One having ordinary skill would reasonably conclude that if TAS3 regulates ARF3, then redirection of TAS3’s silencing capability would impair its ability to regulate ARF3, and would likely lead to outcomes similar to the developmental defects of Dottos’ arf3a tasiR-ARF-insensitive mutants. Dotto also points out that plants defective for the biogenesis of trans-acting short interfering RNAs (ta-siRNAs) show distinctive patterning defects due to the deregulation of key developmental targets, and that the phenotypes vary greatly across species (p. 1, bottom left). Dotto goes on to provide contrasting examples of the phenotypes of plants which are defective in tasi-RNA biogenesis, such as Arabidopsis (a relatively subtle phenotype exhibiting downward curled leaves that are weakly abaxialized and undergo an accelerated transition from the juvenile to the adult phase); Medicago (severe defects in meristem maintenance, mediolateral blade expansion, and adaxial-abaxial leaf polarity) (p. 2, left). Finally, Dotto discloses a high degree of unpredictability in the TAS3 and other tasi-RNA pathways among plant species, stating that while it is evolutionarily conserved, the number and nature of phased siRNA loci vary greatly between plant species…and apparent species-specific TAS pathways may exist (p. 2, bottom left and top right).
To summarize, there is a high degree of unpredictability and variability within the genus of claimed plants, pests, and genes, as well as a great deal which is unknown, all of which would make it difficult for the skilled artisan to envision the plants, pests and genes which would be amenable to the claimed method.
Summary:
Given the vast breadth of the claims, the limited amount of guidance provided by the specification and the art, the high degree of variation among members of the claimed genus, and further the unpredictability in the art, one of ordinary skill in the art would conclude that Applicant was not in possession of the invention as broadly claimed.
Response to Arguments
Applicant's arguments filed 09/10/2025 have been fully considered but they are not persuasive for the reasons that follow.
Applicant argues that, “It would be unduly limiting to restrict the claimed methods to specific plant genes, specific RNA molecules and specific pest organisms. Restricting the claims in this way would be inconsistent with the teaching of the application, which explains that the claimed method is a platform that can be used to silence potentially any pest gene. Indeed, there is no reason why the claimed DNA editing method, utilizing endonucleases, guide RNAs and donor oligonucleotides, would not work in any given plant cell type, for silencing any given pest gene, in the same way as described in the application.” Respectfully, this argument is not convincing because, as discussed in the above rejection, the evidence in the art indicates that there is significant variability and unpredictability in the art of editing plant genes to silence pest genes, which indicates that ordinary artisans could not predict the operability of the method for the full genus of species beyond those discloses. Per MPEP 2163, “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed” (MPEP 2163(II)(3)(a)(ii)). For example, Bally notes, “There have been many additional examples of insects being stunted or killed by RNAi and TK-RNAi, but not all insect species respond equally, nor do the results always appear repeatable.”. What this indicates is that the effects of RNAi on insects varies across species and is unpredictable. Thus, the capability of the claimed method to silence the full scope of any pest gene in any pest (including but not limited to insects) is unpredictable. Respectfully, absent sufficient written description of the vast genus of targeted genes, plants and pests in which the method must be operative, Applicant’s argument that the method can be used to silence “potentially any pest gene” amounts to merely a wish or plan for obtaining the claimed outcome (MPEP 2163(II)(3)(a)).
Respectfully, Applicant’s argument that, “there is a distinction between claims drawn to methods and claims drawn to compositions with respect to the written description requirement” and “a proper written description analysis must focus on Applicant's possession of the claimed method, rather than on the genus of genes targeted by the method” is also not persuasive because the written description requirement does in fact require a sufficient description of the compounds used to practice the method . As stated in MPEP 2163 (emphasis added):
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that "[w]ithout such disclosure, the claimed methods cannot be said to have been described.").
In the instant case, the claimed method is analogous to the above in that it depends upon finding suitable plant genes which may be redirected to silence pest genes. Absent sufficient disclosure of the compounds (i.e., polynucleotides) which would allow the ordinary artisan to carry out the claimed method, the claimed method cannot be said to have been described.
Applicant further raises the argument that, “Courts have long recognized the distinction between a composition claim and a method claim reciting a use of the composition, and warned against treating the method claim like the composition claim in assessing written description.”. This is not persuasive for the reasons already described above: in this case, analogously to the example described above, without a disclosure of which pests and pest genes may be effectively silenced using what plant genes, or a correlation between structure (plant genes, pests, pest genes to be targeted) and function (may be used to carry out the claimed method, i.e., silence a pest gene), the claimed methods cannot be said to have been described.
Applicant also argues that,”the potential effects on plant development and growth are irrelevant, since the health of the plant is not considered in the ambit of the claim, and thus this should not be a matter for consideration. Respectfully, this argument is not persuasive because, while the claims do not specifically address the health of the plant, as a matter of sound scientific reasoning and common sense, for a plant cell to produce sufficient dsRNA to silence pest genes, it must be alive and capable of expressing the required genes. This is supported by the instant specification, which indicates that plant health is a consideration in the selection of plants, genes and pests suitable for the claimed method by stating that, “It will be appreciated that the designed RNA molecule of some embodiments of the invention can have some off-target specificity effect/s provided that it does not affect an agriculturally valuable trait (e.g., biomass, yield, growth, etc. of the plant).”.
Applicant also argues that, “just because e.g. there could potentially be unpredictability in the response of plant pests to dsRNA treatment, this should not preclude a general platform to silence pest genes from patent protection, especially when it is plausible that the claimed method could be used to silence any pest gene of interest. Additionally, the person skilled in the art can identify successful editing events that provide the desired silencing using routine assays, as discussed in the application”. Respectfully, this is not convincing because, as discussed in the above rejection, the genus of claimed plants, genes and pests is vast and varied (including many species for which sequence information is not known), the response of individual pest species to silencing is unpredictable, and the method is not limited solely to successful editing, but rather must lead to an outcome of successful silencing in any combination of any plant or pest which exists.
Conclusion
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.
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/A.M.Z./Examiner, Art Unit 1636
/BRIAN WHITEMAN/Primary Examiner, Art Unit 1636