CONTROL OF INSECT PESTS

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 Applicant’s preliminary amendment filed March 14, 2024 is acknowledged. Claims 46-58 are pending and under examination. Drawings The drawings are objected to because the lines, shadings, numbers and letters of FIGs 1, 3, 5, 7, 10, 12, 14, 16 and 17 are not sufficient to provide satisfactory reproduction characteristics. 37 CFR 1.84(l) states that “all drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined.” In the instant case, the letters and numbers of the scale bars over shading especially in FIGs 7, 10, 12, 14, 16, 17 are not sufficiently dark for reproduction; the text in FIGs 1, 3, 5 is very small and/or of poor resolution to permit satisfactory reproduction characteristics. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at least in paragraphs [0294], [0295], [0313] and [0314]. Applicant is required to delete each of 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. Additionally, the use of the terms Hi-Scribe®, Wizard®, NanoDrop®, Matlab®, SYBR®, SensiFASTTM, GraphPad®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 46-50 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Searle (US 20190059364 A1, published February 28, 2019) in view of Genbank (XM_019051047.1, PREDICTED: Bemisia tabaci aquaporin AQPcic-like (LOC109036687), mRNA; available November 9, 2016). Regarding claims 46-47, Searle teaches administering dsRNA (i.e., a silencing element) to Bemisia tabaci whiteflies ([0038], [0050]). Searle teaches the dsRNA targets the Aquaporin (AQP1) mRNA with NCBI accession number KX390870 ([0042]). Searle teaches the dsRNA was produced by amplification from cDNA isolated from whitefly using AQP1 specific primers ([0042]; Table 1). Searle teaches administering the dsRNA to whiteflies resulted in 50% lethality (i.e., has insecticidal activity against an insect plant pest) (FIG. 11). Searle teaches that on ingestion by the insect, the dsRNA is internalized into cells, where it is cleaved into small interfering RNA (siRNAs) of approximately 21 nucleotides, which guide RISC complexes to degrade complementary mRNAs ([0004]). Searl teaches that RNAi has yielded significant plant protection against at least three other insect plant pathogens ([0004]). Searle does not teach the sequence of the dsRNA targeted to AQP1. Genbank teaches the mRNA sequence of the AQP1 gene from Bemisia tabaci. The primers used by Searle to create the dsRNA are from positions 281-302 (forward) and (421-442) reverse of the mRNA, which would have produced a dsRNA having a polynucleotide that is complementary to position 281-442 of the AQP1 mRNA (page 2, underlined and labeled). Genbank provides evidence that the SEQ ID NO 162 is positions 552-751 of the AQP1 mRNA (page 2, underlined and labeled). Genbank teaches that the coding portion of the AQP1 mRNA spans positions 167-955 (page 2, line 2). Regarding claims 46-47, it would have been obvious to one skilled in the art before the effective filing date of the claimed invention to have designed a dsRNA targeted to and having one strand that complementary to a sequence that is 100% identical to positions 552-751 of the AQP1 mRNA. It would have amounted to designing a dsRNA against a known target having a known mRNA sequence by known means to yield predictable results. Based on Searle’s example it is evident that targeting the AQP1 mRNA transcript with RNAi comprising a dsRNA that has 100% complementarity to the AQP1 mRNA provides insecticidal activity. Because the AQP1 mRNA sequence is known in the art, it was entirely predictable that a dsRNA having a strand that is complementary to any stretch of the coding sequence of AQP1 mRNA could be designed. Additionally, based on the Searle’s disclosure that RNAi has been used to control other insects, it clear that designing dsRNAs against any mRNA target is routine as long as the mRNA sequence is known in the art. It would have been obvious to try the dsRNA having 100% identity to SEQ ID NO 162 because there are finite number of predictable ways to design a dsRNA having 100% complementarity to the known AQP1 mRNA. Furthermore, it would have been routine to screen through each of the possible dsRNAs to determine which dsRNA produces optimal target silencing. However, because each of the predictable solutions would have 100% identity with the AQP1 mRNA, including SEQ ID NO 162 it was entirely predictable that the dsRNAs would have insecticidal activity against whiteflies. Regarding claim 48-50, the dsRNA having a strand that has 100% complementary with SEQ ID NO 162, a 200-mer rendered obvious above, reads on a claim 48-50 that requires the dsRNA to have a strand that is at least 70% identity to a SEQ ID NO 162 complement (claim 48), or at least 19 consecutive nucleotides of SEQ ID NO 162 or a complement thereof (claim 49), or both (claim 50). Regarding claim 58, Searle teaches making transgenic tomato plants engineered to produce the AQP1 dsRNA in planta ([0045]-[0050], [0078]). Claims 51-57 are rejected under 35 U.S.C. 103 as being unpatentable over Searle (US 20190059364 A1, published February 28, 2019) and Genbank (XM_019051047.1, PREDICTED: Bemisia tabaci aquaporin AQPcic-like (LOC109036687), mRNA; available November 9, 2016) as applied to claims 46-50 and 58 above, and further in view of Coelho (US 20190343122 A1, published November 14, 2019). and Mitter (Mitter et al., Nature Plants (2017), 3: 16207). The teachings of Searle and Genbank are recited above and applied as for claim 46-50 and 58. Searle and Genbank do not teach delivering the RNAi as a composition also comprising layered double hydroxide (LDH). Coelho teaches RNAi-based insecticides are RNA interference used for insect pest control and uses dsRNA of about 100-500 nucleotides that is complementary to an essential target gene [0081], [0136], [0137]). Coelho teaches dsRNA can be delivered in a composition with layered double hydroxide (LDH) ([0236]). Coelho teaches once loaded on LDH, the dsRNA does not wash of, shows sustained release, and can be detected on sprayed leaves even 30 days after application ([0236]). Coelho teaches the LDH-dsRNA technology was first described by Mitter in 2017 and used to target RNAs from plant viruses ([0236]). Mitter teaches to form LDH-dsRNA complexes, dsRNA was absorbed into LDH with a mass ratio of 1:4 (Fig 1c; page 2, ¶2). Mitter also teaches LDH-dsRNA at compositions with 1:5 mass ratio, but that 1:4 ratio showed complete loading (Fig 1c, page 2, ¶2) such that at 1:5 about 80% of the dsRNA would be absorbed onto the LDH. Regarding claims 51-57, it would have been obvious to one skilled in the art before the effective filing date of the claimed invention to have combined the dsRNA complementary to SEQ ID NO 162 rendered obvious above for claims 46-50 with the LDH taught in Coelho and Mitter. It would have amounted to the simple combination of known elements by known means to yield predictable results. The skilled artisan would have predicted that the obvious dsRNA could be combined with LDH because 1) Coehlo teaches insecticidal dsRNAs can be delivered with LDH, and 2) Mitter demonstrates a dsRNA-LDH combination. The skilled artisan would have been motivated to have made the composition because Coehlo teaches dsRNA-LDH compositions are stable and effective for delivering insecticidal dsRNA. Regarding claims 56-57, it would have been obvious to specifically produce the combination at a 1:5 mass ratio of LDH to dsRNA, wherein there is 20% excess dsRNA because Mitter teaches that at such a ratio, the LDH is fully saturated and effective at administering the dsRNA onto plants, wherein the skilled artisan would reasonably predict the plant insect pathogens would encounter it. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE KONOPKA whose telephone number is (571)272-0330. The examiner can normally be reached Mon - Fri 7- 4. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ram Shukla can be reached at (571)272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CATHERINE KONOPKA/Primary Examiner, Art Unit 1635