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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-9 and reduced transcript level of DvABCB1 gene in the reply filed on 09/05/2025 is acknowledged.
Claim14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/05/2025.
Claims 1-9 are under examination with respect to reduced transcript level of DvABCB1.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located in Figure 1 and page 33 of the specification.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 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, 4, and 7 recite a method for detecting an insect resistant to a Cry3 class insecticidal protein in a field of crops. The claims encompass the method steps of providing a sample from an insect, assaying the nucleic acids present in the sample and detecting reduced transcript levels of the DvABCB1 gene, wherein reduced transcript levels of DvABCB1 show a Cry3-resistant insect. However the claim lacks antecedent basis for “the DvABCB1 gene”. The step of assaying the nucleic acids from the sample does not require or detect a DvABCB1 gene. The active process steps of providing a sample and assaying the nucleic acid present in the sample does not require analysis of the DvABCB1 gene. There is no nexus between the step of detecting reduced transcript levels of the DvABCB1 gene and the step of assaying the nucleic acids present in the sample. It is unclear if the step of assaying nucleic acids present in the sample results in detecting transcript levels of the DvABCB1 gene or does the step of assaying result in another analysis or detection. Accordingly because there is no nexus between the step of assaying the nucleic acids present in the sample with detecting reduced transcript levels of the DvABCB1, this renders the claim indefinite. The claim does not reasonably apprise one of ordinary skill in the art the scope of the claims, the metes and bonds of the claim are unclear and it would not readily be apparent if one was infringing on the claimed invention.
This rejection could be overcome by amending the step of assaying the nucleic acid present in the sample to recite assaying the nucleic acid present in the sample for a DvABCB1 gene.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 4-5, 7-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims recites an abstract idea and a natural phenomenon.
Claim 1, 4, and 7 recites detecting an insect resistant to a Cry3 class insecticidal protein in a field of crops and detecting reduced transcript levels of the DvABCB1 gene. There is no nexus between the step of assaying the nucleic acids present in the sample and detecting reduced transcript levels of the DvABCB1. The step of “detecting” reduced transcript levels of the DvABCB1 gene and detecting that “shows” a Cry3-resistant insect are all mental processes. Neither the specification or the claims set forth limiting definition for detecting. Additionally the step of detecting inherently encompasses a mental process of a comparison to determine a reduced transcript level. The claims do not set forth how each of these steps are accomplished and the broadest reasonable interpretation is a step that can be accomplished mentally be evaluating data and critical thinking process such that one mentally reads information in a database or report regarding expression of DvABCB1 then draws a mental conclusion. Such detecting encompass process that may be performed mentally and this is an abstract idea.
Claim 2, 5, and 8 recite altering an integrated pest management strategy in a field of crops upon detection of a Cry3-resistant instant. This step is a mental process that encompasses a mental process, a step of evaluating Cry3-resistant insect status, upon detection of a Cry3-resistant insect, and altering an integrated pest management strategy which includes stopping the current strategy.
Claim 1, 4 and 7 recites a law of nature/natural phenomenon. Claims 1, 4, and 7 recite reduced expression of DvABCB1 show a Cry3-resistant insect. The recited relationship is a natural phenomenon that exists apart from any human action. This type of correlation is a consequence of a natural process.
These judicial exception are not integrated into a practical application because the claims do not recite additional steps or elements that integrate the recited judicial exceptions into a practical application. For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological
environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
Claim 1, 4, and 7 recites detecting reduced DvABCB1 show Cry3-resistant insect, however detecting reduced DvABCB1 transcript is an mental process and the broadest reasonably interpretation of detecting reduced transcript levels encompasses mental processes. 2, 5, and 8 recite a step of further comprising altering an integrated pest management strategy in a field of crops upon detection of a Cry3-resistant insect. These claims encompass a mental process step of determining detection and making a conclusion from the detection. Additionally this step does not apply the judicial exception as this step encompasses stopping an integrated pest management strategy. The recitation of alerting a strategy does not require administering or using the judicial exception as altering including stopping the strategy and further recites an additional exception. These additional elements do not apply the judicial exception.
As mentioned above, a claim limitation can integrate a judicial exception by applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. When evaluating this consideration one must the following:
(i) the particularity or generality of the treatment or prophylaxis limitation;
(ii) whether the limitations have more than a nominal or insignificant relationship to the exception; and
(iii) whether the limitations are merely extra solution activity or field of use.
In addition to the judicial exceptions the claims recite type of gene, DvABCB1. These additional steps/elements are not considered to integrate the judicial exception into a practical application because they merely add insignificant extra-solution activity (data gathering) to the judicial exception and further limit the judicial exception.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claims as a whole are not considered to recite any additional steps or elements that amount to significantly more than well-understood, routine, and conventional activities in the art and do not add something significantly more so as to render the claims patent -eligible. The step of assaying nucleic acids present in a sample and detecting reduced transcript levels of the DvABCB1 gene merely instructs a scientist to use well-established routine and conventional nucleic acid techniques to gather samples for diagnostic analysis. As address in the instant specification methods of expression analysis are well-known in the art (See pg. 25, lines 17-22).
The step of determining a biomarker expression in a sample constitutes a data gathering step required to apply the law of nature/natural phenomenon. It is acknowledged that the claims name particular biomarkers, DvABCB1 whose level is to be determined however the claims do not require a particular, non-conventional primer or probe consisting of or comprising a specific nucleotide sequence or any other specific reagent that is used to accomplish such determining such that the claims would recite significantly more than the judicial exception. The targets to be detected are part of the judicial exception and thereby the naming of the targets does not add something “significantly more” to the recited judicial exceptions.
The additional steps and elements are recited at a high degree of generality and are all routine, well understood and conventional in the prior art. The recited steps and elements do not provide inventive concept necessary to render the claims patient eligible. There is no combination of elements in this step that distinguishes it from well-understood, routine and conventional data gathering activity engaged in by scientists prior to applicant’s invention and at the time the application was filed. Many cited prior art references in this record demonstrate that these techniques were conventional at the time of the invention. The prior art of Zhao (2020) teaches detecting reduced transcript levels of ABCB1 to determine Cry toxin resistance. Thus the prior art and specification demonstrates it was routine, well-known and conventional in the art to determine expression of ABCB1 in biological samples. The dependent claims do not provide significantly more to the claims outside of the judicial exception as they encompass conventional techniques as described in the instant specification as noted above.
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 (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).
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, Dv. 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.
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).
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.
Claims 2, 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view of Pauchet and Flagel as applied to claims 1, 4, and 7 above, and further in view of Jakka (Scientific Reports, 2016, 6:27860, pp 1-9).
The method of Zhou in view of Pauchet and Flagel is set forth in section 12 above. Zhou in view of Pauchet and Flagel do not teach altering a pest management strategy upon detection of Cry3 resistant insect.
However, Jakka teaches resistance to Bt toxins Cry3 by D. v. virgifera. Jakka teaches to mitigate resistance, pyramided Bt hybrids crops were planted and teaches the use of refuse (altering a pest management strategy).
Therefore, 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 refuge and pyramid Bt hybrid crop planting, as taught by Jakka.
Claims 2-3, 5-6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view of Pauchet and Flagel as applied to claims 1, 4, and 7 above, and further in view of Rozen (J Appl Entomol, 134, 2010, 376-384).
The method of Zhou in view of Pauchet and Flagel is set forth in section 12 above. Zhou in view of Pauchet and Flagel do not teach altering a pest management strategy or spraying an insecticide to a field of crops upon detection of Cry3 resistant insect.
However, 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).
Therefore, 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 crop rotation and chemical pesticide application to prevent D. v. virgifera pests (see pg. 380, 2nd column).
Conclusion
No claims are allowable.
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.
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/SARAE L BAUSCH/Primary Examiner, Art Unit 1699