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 .
Response to Amendment
The amendment filed 9/8/2025, amending claim(s) 1-6, 15, 18, and 19 and cancelling claim(s) 7 and 8 is acknowledged. Claims 1-3, 6, 15, 18, and 19 are pending and under examination. Applicant’s amendments to the claims have overcome each and every claim objection previously set forth in the Non-Final Office Action mailed 5/9/2025.
Newly amended claims 4 and 5 are withdrawn, as the claims are now drawn to a non-elected species (Aedes aegypti). Drosophila suzukii was previously elected without traverse in the response filed on 3/25/2025.
The amendment to the claims filed on 09/08/2025 does not comply with the requirements of 37 CFR 1.121(c). Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
The correct status identifier for claims 4 and 5 is (Withdrawn- Currently Amended).
The correct status identifier for claim 9 is (Withdrawn) (as claim 9 still directed to a non-elected gRNA, as noted in the previous office action filed 05/09/2025).
Withdrawn Rejections
The Applicant has filed a Declaration (Kandul; 09/08/2025). The Examiner acknowledges and has considered the Kandul Declaration filed under 37 CFR §1.132 on 09/08/2025. The Declaration filed by Kandul states:
“Kandul was publicly disclosed on January 8, 2019 by myself and Omar Akbari, the co-inventors of the ‘348 Application. Kandul was published less than a year before the effective filing date of the claimed invention, July 25, 2019. To the extent that Kandul discloses the subject matter cited in the rejections under 35 U.S.C. § 103 in the Office Action, Kandul discloses my own work and the work of my co-inventor, Omar Akbari. While Junru Liu, Hector M. Sanchez, Sean L. Wu, and John M. Marshall contributed to publication of Kandul, they did not contribute as a co-inventor to the subject matter of the present claims.” (pg. 2).
Therefore, the rejection of the claims under 35 U.S.C. 103 as obvious over Kandul further in view of Li and Laktionov (claims 1, 4, 15, 18, 19), Li, Laktionov, Chiu, and Montague (claims 2, 19), further in view of Li, Laktionov, Chiu, Montague, and Del (claim 3), and Li, Laktionov, and Buchman (claim 6) are withdrawn, as Kandul no longer qualifies as prior art. However, upon further consideration, a new ground(s) of rejection is made in view of Kondo.
Priority
In light of the Applicant’s response filed on 09/08/2025, the claims of the instant case are entitled to the priority date of provisional application 62/878,642, filed 07/25/2019. Support for instant SEQ ID NOs: 66 and 82 are found on pg. 87 of the specification of the provisional application (see Applicant’s Remarks 09/08/2025, pgs. 19-20).
Drawings
The amended drawings were received on 09/08/2025. The drawings are acceptable.
Claim Rejections - 35 USC § 101 - Maintained
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 1-3, 6, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s):
“A mating system producing a genetically modified progeny that is a sterile, sex-sorted male insect of Drosophila suzukii or Aedes aegypti mosquito, comprising a first parental insect and a second parental insect, wherein the first parental insect is a homozygous stock genetically modified to express a CRISPR/Cas9 system, and wherein the second parental insect is a homozygous stock genetically modified to express at least one guide RNA that targets a female specific viability gene in Drosophila suzukii or Aedes aegypti, and at least one guide RNA that targets the male specific fertility Drosophila suzukii or Aedes aegypti;
wherein the female specific viability gene in the Drosophila suzukii is a sex lethal (Sxl) gene;
wherein the female specific viability gene in the Aedes aegypti is selected from a double sex (Dsx) gene, intersex 1, intersex 2, myosin heavy chain (myo-fem), labrum (Lab, sister of sex lethal (Six), homeotic protein Proboscipedia (Pb) or a transformer (Tra) gene;
wherein the male specific fertility gene in Drosophila suzukii is selected from a beta tubulin (Btub) gene, Protamine A (ProtA), Protamine B (ProtB), zero population growth (Zpg),misfire (mfr), meiosis I arrest (mia), sneaky (snky), p-element induced wimpy testis (piwi), or a cannonball gene (Can); and
wherein the male specific fertility gene in Aedes aegypti is selected from a Btub gene, , Protamine A (ProtA), Protamine B (ProtB), misfire (mfr), meiosis I arrest (mia), sneaky (snky), or p-element induced wimpy testis (piwi), or a zero population growth (Zpg) gene”.
According to the 2019 Revised Patent Subject Matter Eligibility Guidelines (2019PEG), the claim is first analyzed to determine if it is directed to one of the acceptable statutory categories of invention (i.e., process, machine, manufacture, or composition of matter). Claim 1 is drawn to a mating system for producing a genetically modified progeny (i.e., a process). Thus, claim 1 meets the requirements for step 1 analysis.
Second, the claim is assessed to determine if it is directed to a judicial exception under step 2A. Under 2019PEG, “directed to” is determined via a two-prong inquiry: (1) Does the claim recite a law of nature, a product of nature, a natural phenomenon, or an abstract idea; and (2) Does the claim recite additional element(s) that integrate the judicial exception into a practical application. The phrase, “integration of a practical application”, requires the presence of an additional claim element(s) or a combination thereof to apply, rely on, or use the judicial
exception in a manner that imposes a meaningful limitation on the judicial exception, such that the claim does not monopolize the judicial exception (See MPEP § 2106.05 for examples of
integration of practical application).
Regarding the first prong (1), claims 1 and 4 are directed to a mating system for producing a genetically modified progeny that is a sterile, sex-sorted male insect of Drosophila suzukii, the mating system comprising a first parental insect that is a homozygous stock genetically modified to express a CRISPR/Cas9 system, and a second parental insect that is a homozygous stock genetically modified to express two gRNAs. The broadest reasonable interpretation of “a mating system” encompasses mental processes such as observations, evaluations, and judgements that can be performed in the human mind (i.e., abstract idea). Additionally, the “mating system” is recited at a high level of generality, and is merely an extra-solution activity (see MPEP 2106.05(g)). There are no active steps recited on how to carry out the process (i.e., system), only recitations on the parental insects that are part of the process. As such, the claims are drawn to an abstract idea and the first prong of the inquiry demonstrates that the claim is directed to a judicial exception. The claimed mating system reasonably reads upon the illustration of Figure 1a of the instant specification, which is judicial exception abstract thought.
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Claims 18 and 19 differ from claims 1-3, 6, and 15, as they are directed to a engineered polynucleotide sequence (i.e., a product).
Regarding the second prong (2), dependent claims of claim 1 further defines characteristics of the parental insects of the process, but do not provide any active method steps for the process. Additionally, claim 15 is directed to the progeny created by the mating system. Further defining the target sequence(s) of the D. suzukii, and claiming the product of the process and an element used in the process fails to integrate the judicial exception into a practical application. Thus, the claims meet the requirement of step 2A as being directed to a judicial exception.
Third, if a judicial exception is present in the claim, it is further assessed to determine if
the claims recite any additional elements or steps that are sufficient to ensure that the claim as
a whole amounts to significantly more than the judicial exception. As discussed above, the
additional elements recited in the claims are limiting what sequences the parental insects comprise, which does not further limit the abstract idea judicial exception. In addition, the lack of steps and limitation(s) of what the target and regulatory element sequences may be does not impart any particular structural or functional limitation that further limits the generic nature of the abstract idea of a mating system. Thus, the claims do not meet the requirement for step 2B of the analysis.
In conclusion, claims 1-3, 6, and 15 do not meet all the requirements of the 2019PEG subject matter patentability. Therefore, the claims are deemed patent ineligible.
Claim Rejections - 35 USC § 112(b)
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.
Claim 19 is 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.
Claim 19 recites the limitation "The engineered polynucleotide sequence of claim 16" in line 1. There is insufficient antecedent basis for this limitation in the claim, as claim 19 is dependent upon withdrawn claim 16, directed to a method of reducing a wild-type insect population. It would be remedial to amend claim 19 to depend upon claim 18, directed to an engineered polynucleotide sequence. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 15, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kondo (Kondo, Shu, and Ryu Ueda. “Highly improved gene targeting by germline-specific Cas9 expression in Drosophila.” Genetics vol. 195,3 (2013): 715-21. doi:10.1534/genetics.113.156737) in view of Li (Li, Fang, and Maxwell J. Scott. "CRISPR/Cas9-mediated mutagenesis of the white and Sex lethal loci in the invasive pest, Drosophila suzukii." Biochemical and biophysical research communications 469.4 (2016): 911-916.; cited in IDS filed 04/15/2025, previously cited) and Laktionov (Laktionov, Petr P., et al. "Genome-wide analysis of gene regulation mechanisms during Drosophila spermatogenesis." Epigenetics & Chromatin 11 (2018): 1-15, previously cited).
Regarding claims 1, 15, and 18, Kondo teaches a mating system producing a genetically modified progeny (claim 15) that is a sex-sorted male insect of Drosophila comprising a first parental insect and a second parental insect, wherein the first parental insect is a homozygous stock genetically modified to express a CRISPR/Cas9 system (e.g., nos-Cas9 strain), and wherein the second parental insect is a homozygous stock genetically modified to express at least one gRNA (gRNA strain) (Figure 1). The nos-Cas9 and U6-gRNA lines are crossed to obtain founder animals that expressed an active Cas9–gRNA complex specifically in the germline, thereby inducing mutations in target genes (e.g., sex-linked white gene) (pg. 717, col 2). For example, each of the six gRNAs targeting white was highly effective in inducing white mutants. All founder males expressing Cas9–gRNA produced at least one white mutant offspring (pg. 718, col 2, para 2). Additionally, to test if larger deletions could be induced by simultaneous cleavage of two sites by Cas9–gRNA, the authors constructed a transformation vector that contains two U6-gRNA transgenes (Figure 2D; see Materials and Methods for details). Each of
the two gRNAs, w-ex3-1 and w-ex6-1, targeted one of two sites separated by 1.6 kb (Figure 2, A and E). From the cross between male flies carrying double-gRNA and nos-Cas9 and compound-X females, white mutants were obtained in the progeny at a frequency of 91% (Figure 2D) (pg. 719, col 1, para 2). As evidenced in Figure 2D, one of the parental insects was homozygous stock genetically modified to express a CRISPR/Cas9 system (e.g., nos-Cas9), while the second parental insect was homozygous stock genetically modified to express at least two gRNAs. Kondo notes that it is highly feasible to generate transgenic U6-gRNA lines targeting all genes and derive mutants from them in a reasonable time frame (pg. 720, col 2, last para).
Kondo is silent on whether the Drosophila used in the study were Drosophila suzukii (D. suzukii). At most, Kondo refers to Drosophila melanogaster in the introduction paragraph. Additionally, Kondo does not teach the gRNAs targeting the female specific viability gene Sxl,
Li teaches using the CRISPR/Cas9 system to introduce site-specific mutations in the D. suzukii white (w) and Sex lethal (Sxl) genes, noting that the D. suzukii Sxl gene could be an excellent target for a Cas9-mediated gene drive to suppress populations (Abstract).
Additionally, regarding claim 19, Li teaches targeting a sequence required for female-specific viability in D. suzukii (i.e., Sxl) that shares 100% with instant SEQ ID NO: 82 (pg. 914, Fig. 3F and description bottom of pg. 915).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to apply the teaching of utilizing a CRISPR/Cas9 system in D. suzukii and targeting instant SEQ ID NO: 82 as taught by Li in order to genetically modify progeny to the mating system of Kondo and arrive at the claimed invention. One would have a reasonable expectation for success because Li teaches that D. suzukii is closely related to Drosophila melanogaster, which has been widely used for genetic studies (pg. 911, Introduction, para 1). Additionally, Li teaches utilizing Cas9 and gRNA expression systems that had been developed for editing D. melanogaster genes, suggesting that other systems developed for studying genes in D. melanogaster could be applied to D. suzukii (pg. 913, Discussion, para 1).
One would have a reasonable expectation of success because the simple substitution of one known element (i.e., substitute gRNA for Sxl instead of gRNA w-ex3-1 in the mating system of Kondo) for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Further, an artisan would have a reasonable expectation of success for applying the teaching of targeting instant SEQ ID NO: 82 as taught by Li would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” “When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).” M.P.E.P. §2144.06.
An artisan would be motivated to apply the teachings of Li because as taught by Li, targeting instant SEQ ID NO: 82 in D. suzukii female insects led to successful generation of somatic mosaic females that developed abnormal genitalia and reproductive tissue (Abstract). Additionally, Li teachings that D. suzukii is an invasive pest that is a serious pest of soft-skinned fruits, and Cas9-mediated gene drives have been suggested as an effective means for controlling pest populations (pg. 916, col 1, para 2).
Kondo does not teach the male sterility genomic sequence being Cannonball (Can).
Laktionov teaches that Cannonball (Can) is required for Drosophila spermatogenesis. Laktionov created testis‑specific TBP‑associated factor (tTAF) (i.e., Cannonball in Laktionov) deficient mutants, demonstrating a strong dependence on tMAC in spermatocytes (Abstract; pg. 2, col 2, paras 2 and 4). Additionally, Laktionov used CRISPR/Cas9 genome editing to target a different gene of interest (CG9879) in the study.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to apply the teaching of Laktionov that Cannonball is a known protein associated with spermatogenesis to the mating system of Kondo to arrive at the claimed invention of targeting Cannonball in Drosophila in order to produce sterile male insects. One would have a reasonable expectation of success because the simple substitution of one known element (i.e., substitute gRNA targeting Cannonball instead of gRNA w-ex6-1 in the mating system of Kondo) for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” “When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).” M.P.E.P. §2144.06. An artisan would be motivated to apply the teachings of Laktionov because as taught by Laktionov, disrupting the Can gene in Drosophila led to the testes of meiosis arrest mutants accumulating spermatocytes that fail to enter downstream spermatogenesis stages (pg. 5, col 2, para 3).
Therefore, the combination of Kondo, Li, and Laktionov would lead one of ordinary skill at arrive at the claimed invention.
Claim(s) 2 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kondo, Li, and Laktionov as applied to claims 1, 4, 15, 18, and 19 above, and further in view of Chiu (Chiu, J. C., X. Jiang, L. Zhao, C. A. Hamm, J. M. Cridland, P. Saelao, K. A. Hamby, E. K. Lee, R. S. Kwok, G. Zhang, F. G. Zalom, V. M. Walton, and D. J. Begun (2013). Genome of Drosophila suzukii, the Spotted Wing Drosophila. G3: Genes, Genomes, Genetics 3(12):2257-71, previously cited) and Montague (Montague, Tessa G., et al. "CHOPCHOP: a CRISPR/Cas9 and TALEN web tool for genome editing." Nucleic acids research 42.W1 (2014): W401-W407, previously cited).
Kondo, Li, and Laktionov do not teach the targeted sequence required for male-specific fertility in D. suzukii being SEQ ID NO: 66 (i.e., Can).
Chiu teaches the genome of D. suzukii, including the transcript sequence of Can (see NPL “Gene Report- SpottedWingFlyBase_Cannonball). As demonstrated below, Chiu teaches that instant SEQ ID NO: 66 shares 100% identity with a section of the known transcript sequence of Can in D. suzukii (in boxed section of Transcript Sequence):
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Montague teaches that the ordinary artisans had ready access to online web-based tools to select and design guide RNA targeting sequences for CRISPR/Cas gene editing systems, whereby the ease of use and speed of CHOPCHOP make it a valuable tool for genome engineering. Montague teaches that the ChopChop tool is able to “rigorously predict off-target binding of single-guide RNAs (sgRNAs)”, provide “an array of advanced options for target selection”, producing “an interactive visualization of the gene with candidate target sites displayed at their genomic positions and color-coded according to quality scores (Abstract), thereby allowing the ordinary artisan to select guide RNA target sequences within the nucleotide search parameters. Since Laktionov above teaches why an artisan would choose to target Cannonball, an artisan could have copy/pasted the Cannonball D. suzukii nucleotide sequence taught by Chiu into ChopChop (https://chopchop.cbu.uib.no/), which would then provide an artisan with a list of candidate sgRNAs, one or more of which may be the elected gRNA or substantially overlap with the elected gRNA (SEQ ID NO: 66).
Prior to the effective filing date of the instantly claimed invention, it would have been obvious to one of ordinary skill in the art to try a gRNA comprising a target nucleotide sequence comprising instant SEQ ID NO: 66 with a reasonable expectation of success because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipate success, it is likely that product not of innovation but of ordinary skill and common sense.” One of ordinary skill in the art would understand how to design nucleic acid molecules encoding guide RNA target sequences directed to the previously known D. suzukii Cannonball nucleotide sequences, the artisan merely using readily available online guide RNA tool resources with which to identify the finite potential options, whereby the ordinary artisan could have pursued the known potential options with a reasonable expectation of success. CHOPCHOP provides clear evidence of the equivalence of D. suzukii Cannonball RNA target sequences. The number of possible D. suzukii Cannonball RNA target sequences from which to choose is neither astronomical nor insurmountable, and given the guidance of Kondo, Li, and Laktionov, it would be only routine experimentation to determine which guide RNAs achieve transcriptional activation when the CRISPR/Cas/guide RNA system is bound to the target domain.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kondo, Li, and Laktionov, as applied to claims 1, 4, 15, 18, and 19 above, and/or Kondo, Li, Laktionov, Chiu, and Montague as applied to claims 2, 4, and 19 above, and further in view of Del (Del Amo, Víctor López, et al. "Small-molecule control of super-Mendelian inheritance in gene drives." Cell reports 31.13 (2020).; published 06/30/2020, previously cited).
Regarding claims 3 and 5, Kondo, Li, Laktionov, Chiu, and Montague do not teach the regulatory sequence comprising a promoter comprising nt 4360 to nt 6582 of SEQ ID NO: 1.
Del teaches a gene-drive system in Drosophila that generates an analog inheritance output that can be tightly and conditionally controlled to between 50% and 100%. This technology uses a modified SpCas9 that responds to a synthetic, orally available small molecule, fine-tuning the inheritance probability.
Del teaches expression vector pVG312_vasa-DD2-Cas9, nt 3276 to nt 5498 of which shares 100% identity with nt 4360 to nt 6582 of instant SEQ ID NO: 1 (Result 5 of Sequence Search File: 20250403_153333_us-17-629-348-1_copy_4360_6582.align50.rge). The pVG312_vasa-DD2-Cas9 construct was generated for gene drive assessment of TMP-regulated SpCas9 (Supplementary Figure S2A
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to substitute the regulatory sequence for directing protein expression and its sequence in the mating system taught by Kondo, Li, Laktionov (and Chiu, and Montague) with a sequence (i.e., nt 3276 to nt 5498 of expression vector pVG312_vasa-DD2-Cas9) taught by Del with a reasonable expectation for success. An artisan would have a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” “When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re
Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).” M.P.E.P. §2144.06.
Further, replacing a sequence with another has long been done in the molecular biology art and would be routine. One would be motivated to replace the regulatory sequence in the mating system taught by Kondo, Li, Laktionov (and Chiu, and Montague) because as taught by Del, the system (which comprises expression vector pVG312_vasa-DD2-Cas9) opens a new avenue to feasibility studies for spatial and temporal control of gene drives using small molecules (Abstract; pg. 3, “A Small Molecule Can Control the Inheritance of a GeneDrive System in Drosophila”).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kondo, Li, and Laktionov as applied to claims 1, 4, 15, 18, and 19 above, and further in view of Buchman (Buchman, Anna, et al. "Synthetically engineered Medea gene drive system in the worldwide crop pest Drosophila suzukii." Proceedings of the National Academy of Sciences 115.18 (2018): 4725-4730, previously cited).
Kondo, Li, and Laktionov do not teach a deadhead (Dhd) or bicoid (BicC) promoter.
Buchman teaches a synthetic Maternal Effect Dominant Embryonic Arrest (Medea) gene drive system in D. suzukii (Abstract). Buchman teaches creating a synthetic Medea gene drive in D. suzukii by engineering a piggyBac vector, including the use of the predicted D. suzukii BicC promoter from D. suzukii genomic DNA (pg. 4729, Materials and Methods, “Construct Assembly”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to substitute the promoter (e.g., Nanos (nos), or Ubiquitin-63E (Ubi), or Vasa (vas)) in the mating system taught by Kondo, Li, Laktionov with the BicC promoter taught by Bachman with a reasonable expectation for success. An artisan would have a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” “When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re
Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).” M.P.E.P. §2144.06.
Further, replacing a regulatory element/promoter with another has long been done in the molecular biology art and would be routine. One would be motivated to replace the promoter in the mating system taught by Kondo, Li, Laktionov because as taught by Bachman, the bicoid (BicC) promoter is a female germline-specific promoter that in Bachman’s study, successfully drove expression of a “toxin” consisting of a polycistronic array of four synthetic miRNAs each designed to target the 5′UTR of D. suzukii myd88 (pg. 4726, Results, “Generation of a Synthetic Medea Gene Drive”).
Response to Arguments
Applicant's arguments filed 09/08/2025 have been fully considered but they are not persuasive.
Regarding the 101 rejection, the Applicant argues that the claimed mating system includes modified biological components that are “markedly different than anything found in nature, as any nature based product would not include genetic modifications resulting in the expression of a CRISPR/Cas9 system or guide RNAs that target male fertility genes and female viability genes”. Further, the outcome of the mating system has real-world utility in pest control and vector management, and the technical improvements are neither routine nor conventional (see pgs. 22-23 of Remarks). These arguments are not persuasive because they fail to distinctly respond to and point out how and why the mating system does not encompass an abstract idea. The real-world utility of the product of the mating system, and whether the modified biological components used in the claimed mating system does not address the lack of method steps in the claimed process, for example. Therefore, the 101 rejection of claims 1-3, 6, and 15 is maintained.
Conclusion
No claims are allowed.
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ALLISON M. JOHNSON
Examiner
Art Unit 1638
/ALLISON MARIE JOHNSON/Examiner, Art Unit 1638
/KEVIN K HILL/Primary Examiner, Art Unit 1638