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
Currently, claims 1, 4, 7, 14 are pending in the instant application. Claims 2-3, 5-6, 8-13 have been canceled and claim 14 is withdrawn. This action is written in response to applicant' s correspondence submitted 06/12/2026. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant' s amendments to the claims.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. This action is FINAL.
Claims 1, 4, 7 are under examination with respect to reduced transcript level of DvABCB1.
The amendment to the specification filed 6/12/2026 has been entered. The amendment to the drawings filed 05/18/2026 has been entered.
Withdrawn Rejections
The rejection of claims 1-9 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of the amendment to the claims.
The rejection of claims 1-2, 4-5, 7-8 under 35 USC 101 is withdrawn in view of the amendment to the claims.
The rejection of claims 1, 4, and 7 under 35 U.S.C. 103 as being unpatentable over Zhou (Pest Manag Sci, 2020, 76:712-720, published online Aug 2019) in view of Pauchet (2016, cited on IDS) and Flagel (2015, cited on IDS) is withdrawn in view of the amendment to the claims.
The rejection of claims 2, 5 and 8 under 35 U.S.C. 103 as being unpatentable over Zhou in view of Pauchet and Flagel and further in view of Jakka (Scientific Reports, 2016, 6:27860, pp 1-9) is withdrawn in view of the amendment to the claims.
New Grounds of Rejection – Necessitated by Amendment to the Claims
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1, 4, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view of Pauchet (2016, cited on IDS), Flagel (2015, cited on IDS) and Rozen (J Appl Entomol, 134, 2010, 376-384).
Zhou teaches ABCB1 gene has been confirmed to be involved in tolerance or resistance to different classes of chemical insecticides in multiple insects. Zhou teaches ABCB1 gene is associated with resistance to Cry3Bb1 and Cry3Aa toxins from Bt in Diabrotica virgifera virgifera and Chrysomela tremula (see pg. 713, 1st column). Zhou teaches expression of Plutella xylostella ABCB1 is linked to resistance to Bacillus thuringiensis (Bt) Cry1Ac toxin. Zhou teaches obtaining midgut tissue from different P.xylostella strains (sample from insect) and isolating total RNA (see 2.3, pg. 713). Zhou teaches qPCR to determine transcript levels of PxABCB1 (see 2.7, pg. 714). Zhou teaches down regulation of PxABCB1 is genetically linked to high level resistance to Bt Cry1Ac toxin (see 2nd column pg. 717). Zhou teaches ABCB1 has been found to be genetically linked to resistance and to Bt Cry3 toxins in two coleopteran insects, Dvv. Virgifera and C. tremula (see 2nd column, pg. 717). Zhou does not teach reduced ABCB1 expression and resistance of Bt Cry3 toxin in D. v. virgifera or spraying an insecticide to a field of crops upon detection of Cry3 resistant insect.
Pauchet teaches Chrysomela tremula, a coleopteran insect, Cry3Aa resistance is linked to reduced expression in ctABCB1. Pauchet teaches extracting RNA form larval midgut of C. tremula. Pauchet teaches detecting decreased expression of CtABCB1 in Sf9 cells (see 4.3) (see fig 3).
Flagel teaches Dvv ABCB1 is genetically linked to resistance to Bt Cry3Bb1 toxin. Dvv is a coleopteran insect. Flagel teaches genetic markers for Western corn rootworm (Diabrotica virgifera virgifera). Flagel teaches obtaining samples from insects that were resistant to Cry3Bb1 toxin (see population collection and bioassay). Flagel teaches obtaining nucleic acid samples and genotyping (see preparing WCR mapping families, phenotyping and genotyping and validation). Flagel teaches genetic markers with Bt toxin resistance in ABCB subfamily (see fig S6) and teaches a genetic link to ABCB1 (see fig S4) (see 1st column, last paragraph, pg. 404).
Rozen teaches chemical control of D. virgifera virgifera. Rozen teaches crop rotation in the primary control tool for D..v. virgifera and use of insecticides continues to be an option, including chemical pesticide application (see pg. 380, 2nd column and pg. 381, 2nd column).
Given the prior art teaches ABCB1 genetically linked to resistance of Cry toxins, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to improve the method of detecting decreased expression of PyABCB1 and Cry toxin resistance as taught by Zhou to include additional known ABCB1 genes and Cry toxin resistance, as taught by Pauchet and Flagel including DvvABCB1 expression with Cry3 toxin resistance. The skilled artisan would have been motivated to include analysis of Dvv ABCB1 expression because Zhou teaches reduced expression of ABCB1 gene and Cry toxin resistance, Pauchet teaches reduced expression of ctABCB1 in a coleopteran insect, C. tremula, and teaches Cry3 resistance and Flagel teaches D.v.virfera, a coleopteran insect, has a genetic link in ABCB1 to Cry3 resistance. The skilled artisan would have a reasonable expectation of success that a decreased expression of DvvABCB1 would be resistant to Cry3 toxin because Flagel teaches a genetic link in DvvABCB1 with Cry3 toxin resistance and the prior art, as demonstrated by Pauchet and Zhou, teach reduced expression of ABCB1 with Cry toxin resistance in other species.
Furthermore, it would be prima facie obvious to one of ordinary skill in the art to mitigate resistance to Cry3 toxins in the method of Zhou in view of Pauchet and Flagel in crops by providing chemical pesticide application to prevent D. v. virgifera pests (see pg. 380, 2nd column).
Response to Arguments
The response traverses the rejections under 35 USC 103 on pages 11-14. While the rejection of Zhou in view of Pauchet and Flagel is withdrawn due to the amendment to the claims, the traversal is relevant to the rejection above and will be addressed.
The response asserts that one of ordinary skill in the art would not have a reason to combine the cited references in an attempt to reach the claimed subject matter. The response asserts that in coleopteran insects at least several different proteins are suggested to be associated with Cry3 toxicity. The response asserts that although Pauchet suggests identification of ABC transporter acting as Cry3Aa receptor in C. Tremula this does not provide evidence that an ABC protein will also function as a receptor for the same toxin in a different species. This response has been thoroughly reviewed but not found persuasive. Determination of obviousness is on what a person of ordinary skill in the pertinent art would have known at the time of the invention and on what a person would have reasonably expected to have been able to do in view of that knowledge. Thus, a person of ordinary skill in the art based on the Pauchet, Zhou, and Flagel would have expected that a reduced transcript level of DvABC1 is associated with Cry3-resistant insect. Zhou teaches downregulation of PxABCB1 is linked to high resistance of Bt Cy1AC toxin. Pauchet teaches Cry3Aa resistance is linked to reduced expression of ctABCB1 and Flagel teaches DvvABCB1 is genetically linked to resistance in Cry3Bb1 toxin. Based on the teachings of the prior art, a person of ordinary skill in the art would have been reasonably expected that reduced transcript levels of DvABCB1 show Cry-3 resistant insect. While the response asserts that Pauchet suggests identification of ABC transporter acting as a Cry3Aa receptor this does not provide evidence that an ABC protein will function as a receptor for the same toxin in a different species, this is not found persuasive. It is noted that Pauchet was cited because Pauchet teaches Cry3Aa resistance is linked to reduced expression of ctABCB1, demonstrating that another coleopteran insect has Cry3Aa resistance which is linked to reduced expression of ctABCB1. As such the ordinary artisan would have had a reasonable expectation of success that reduced ABCB1 expression in other coleopteran insects would have the same Cry3 resistance.
The response asserts that Zhou is involved with Plutella xylostella and not Diabrotica virgifera. The response further asserts that Zhou asserts in vivo evidence to determine causal relationship between alternations in PxABCB1 gene and Cyr1Ac resistance in P. xylosteall. This response has been reviewed however as address in the rejection Zhou was not cited to teach Dibrotica virgifera. Zhou was cited to teach ABCB1 genes involved in tolerance of resistance to different classes of chemical insecticides in multiple insects. Additionally Zhou teaches that in vivo evidence is still required to determine causal relationship between alterations in PxABCB1 gene and Cyr1Ac resistance, this is with respect to alterations in PxABCB1 gene not downregulation of PxABCB1. In fact the same citation teaches downregulation of PxABCB1 gene is genetically linked to high resistance to BtCry1Ac toxin, therefore demonstrating reduced transcript levels of ABCB1 is associated with Cry toxins.
The response asserts that one of ordinary skill in the art would not have combined the teachings of Zhou with Pauchet and Flagel in an attempt to reach the claimed subject matter. The response asserts that Pauchet suggests in supplement fig S4 that the ABC protein associated with Dvv-isotig07787 is linked to Cry3 toxin resistance and not ABC protein associated with homologous Dvv-isotig11620. The response asserts that supplemental fig S4 indicates that Dvv-isotig11620 is not linked to Cry3 toxin resistance. This response has been reviewed but not found persuasive. The claims are not limited to any specific DvvABCB1 sequence. Supplement fig S4 denotes proteins genetically linked to Cry3 toxin, including one DvvABCB1 sequence, Dvv-isotig07787. Genetically linked to Cry3 toxin, as taught by Pauchet, refers not to reduced transcript levels but to a mutation in an ABC protein (see abstract). The elected species for the instant claims is not detecting an altered sequence but reduced transcript levels of DvcABCB1, as such under examination is with regard to reduced transcript levels of DvvABCB1, which is not limited to any specific DvvABCB1 sequence. Claims 1, 4, and 7 recite detecting reduced transcript levels of DvABCB1 gene and is not limited to any specific sequence. Pauchet does not teach that reduced transcript levels of DvvABCB1 is not associated with Cry3Aa resistance and in fact Pauchet teaches that there is a genetic link in DvvABCB1 with Cry3Aa resistance, as such the ordinary artisan would have been motivated to determine reduced transcript levels of DvvABCB1 and Cry3 resistance.
The response further asserts that one of ordinary skill in the art would not have a reason to combine the cited reference in an attempt to reach the claimed subject matter with a reasonable expectation of success as the cited references relate in some instances to other insect species or reference ABC proteins other than that encoded by SEQ ID NO 1. This response has been reviewed but not found persuasive. The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the teaching of Zhou, Pachet and Flagel teach reduced expression of ABCB1 transcript in different insects within the same class, coleopteran, and resistance to Cyr toxins. The claims are not limited to measuring decreased transcript level of SEQ ID NO 1. The claims recite reduced transcript level of DvvABCB1. Even arguendo the claims requires the specific sequence of SEQ ID NO1, the teachings of Zhou in view of Pachet and Flagel render obvious the claimed invention, including analysis of SEQ ID NO 1. As addressed previously given the prior art teaches ABCB1 is linked to resistance of Cry toxins in coleopteran insects, the ordinary artisan would have been motivated to determine ABCB1 transcript levels in other coleopteran insects including D. v. virgifera and other Cry toxins including Cry3. Additionally because Pauchet teaches there is a genetic link in DvvABCB1 with Cry3Aa resistance, the ordinary artisan would have had a reasonable expectation of success that measuring reduced transcript levels of DvvABCB1 would show Cry3-resistant insect because Pauchet teaches reduced expression of ABCB1 in Chrysomela tremula and Zhou teaches reduced expression of ABCB1 in Plutella xylostella in Cry1Ac toxin, as such the prior art demonstrates reduced expression of ABCB1 in different coleopteran insects with Cry toxin resistance.
With regard to the rejection of Rosen, the response asserts on page 14 that Rosen does not remedy the deficiencies set forth above regarding Zhou, Pauchet, and Flagel. However, as addressed above Zhou, Pauchet, Flagel and Rosen render the claimed invention obvious for the reasons of record. For these reasons and reasons of record this rejection is maintained.
Conclusion
No claims are allowable.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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, Fereydoun Sajjadi can be reached at 571-272-3311. 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.
/SARAE L BAUSCH/Primary Examiner, Art Unit 1699
Prosecution Insights