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 .
Election/Restrictions
[Copied from the Nonfinal Action Dated 22October2024 → ] Applicant's election with traverse of Group I (claims 1 and 3-13) in the reply filed on 19August2024 is acknowledged. The traversal is on the ground(s) that WOLTER et al. do not teach the new recitation at claim 1 of “making a precise gene edit with a reduced percentage of mutations comprising random insertions and/or deletions”; therefore, unity is not broken and the two Groups (Group I and Group II) should be examined together. This is not found persuasive because that new recitation is indefinite and, in any event, would have been an obvious and inherent feature of using paired nickases (see obviousness rejection of claim 1 herein below). To that end, unity of invention is still broken in view of prior art references. Furthermore, claim 2 (in Group II) has also been newly amended and in a manner that is distinct from claim 1: note that claim 2 encompasses no off-target mutations whereas claim 1 only requires a reduced percentage (= Applicant has introduced an additional, distinguishing feature into each of Groups I and II that may form the basis for restriction).
The requirement is still deemed proper and is therefore made FINAL.
Claims 2, 14-24 REMAIN withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group of invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 19August2024.
Applicant’s election of species Cas9 nickase, delivery via ribonucleoprotein (RNP) complexes and particle bombardment in the reply filed on 19August2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 6-9 REMAIN withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19August2024.
For clarity of the record, Applicant also elected the delivery of RNA (from species grouping (C)), but that election is irrelevant in view of having elected delivery via ribonucleoprotein (RNPs).
Status of the Claims
The amendments and arguments filed 20February2026 are acknowledged and have been fully considered. Claims 1-24 are pending. Claims 1-2, 10 are currently amended. Claims 3-9, 11-24 were previously presented. Following the restriction requirement mailed 19April2024 and Applicant’s election dated 19August2024, claims 2, 6-9, 14-24 remain withdrawn as being directed toward a non-elected group and/or species (rejoinder currently being inappropriate).
Claims 1, 3-5, 10-13 are examined on the merits herein.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(a)-(d) and (f) [foreign applications EP19216386.3 filed 16December2019, EP20155128.0 filed 03February2020, EP20211151.4 filed 02December2020] and 35 U.S.C. 365(c) [PCT/EP2020/084799 filed 07December2020] is acknowledged. Claims 1, 3-5, 10-13 MAINTAIN an effective filing date of 16December2019.
Withdrawn Objections and/or Rejections
Objections and/or rejections made of record in the nonfinal office action dated 20October2025 that are not otherwise discussed herein are withdrawn. In particular:
RE ¶ 7: The objection to claim 1 is withdrawn in view of the claim amendments;
RE ¶¶ 8-9: The Indefiniteness rejections are withdrawn in view of the claim amendments;
RE ¶¶ 10-11: The Written Description and Enablement rejections are withdrawn in view of the amendments to claim 1 whereby the phrase “… without any InDels …” is removed. As said at ¶6 of the nonfinal action dated 20October2025: “The obviousness rejections are withdrawn because independent claim 1 has been amended to recite that the donor DNA is inserted into the target region “without ANY InDels, duplications or other mutations”, which is an effect that is neither described by the specification nor enabled (to that end, see the rejections herein below under 35 U.S.C. § 112(a)). Applicant should note that the obviousness rejections will be reinstated if/when “without any” is corrected to recite a reduction in off-target mutations (as compared to a nuclease), or similar language to that effect.”
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.
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.
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, 5, 11 REMAIN rejected under 35 U.S.C. 103 as being unpatentable over WOLTER et al. (“Efficient in planta gene targeting in Arabidopsis using egg cell-specific expression of the Cas9 nuclease of Staphylococcus aureus” 2018 The Plant Journal 94:735-746; of record Form-892 19April2024) and MIKAMI et al. (“Precision Targeted Mutagenesis via Cas9 Paired Nickases in Rice” 2016 Plant Cell Physiol. 57(5):1058-1068; of record IDS 02August2024), and X.LIANG et al. (“Enhanced CRISPR/Cas9-mediated precise genome editing by improved design and delivery of gRNA, Cas9 nuclease, and donor DNA” 2017 J. Biotech. 241:136-146).
The claims filed 20February2026 are amended to remove the phrase “without any InDels …” (= overcoming the Written Description and Scope of Enablement rejections in the Nonfinal dated 20October2025). As stated at ¶6 of the Nonfinal Dated 20October2025, these Obviousness rejections of record are reinstated in view of the phrase “without any InDels …” being deleted. The rejection(s) as set forth in the Final action dated 11April2025 are copied below (which were copied from those set forth in the nonfinal action dated 22October2024). Applicant’s Remarks (20February2026) and the arguments within the De VLEESSCHAUWER Declaration (20February2026) are addressed below the rejection and within the “Response to Applicant’s Remarks” section.
↓Rejection Of record↓
WOLTER et al. teach introducing a point mutation into the acetolactate synthase (ALS) gene of Arabidopsis plants by transforming into plants (via Agrobacterium-mediated transformation) a DNA plasmid/construct comprising “a donor DNA molecule” used as a template for repair; at least one Cas9 nickase (comprising a “D10A’ mutation, referred to therein as “SpCas9-D10A” for example); and two gRNA cassettes1 whereby “the nickase was used in conjunction with two sgRNAs that recognized sequences on opposite strands 30 to 50 bp apart to induce paired nicks, resulting in a [Double Stranded Break] with a longer 3’ or 5’ overhangs” (WOLTER et al. at the right column of page 742). [claims 1, 4-7].
MIKAMI et al. teach/evidence that at the time this application was filed, the prior art already knew that the use of a Cas9 paired nickase approach for gene editing reduces off-target mutations including insertions and/or deletions [relevant to lines 1-2 of claim 1].2 Further to what is taught by WOLTER et al., MIKAMI et al. also teach/evidence that at the time this application was filed, the prior art already knew that the distance between nicks is dependent upon the distance between paired guide RNAs3 [relevant to the last line of claim 1].
X.LIANG et al. teach/evidence that at the time this application was filed, the prior art already knew how to select and design CRISPR gene editing components for increased efficiencies4 including, for example, how to design guide RNA (gRNA)5 and donor DNA (including for efficient donor DNA introduction into the target site/region)6 [relevant to claim 11].
Based on the teachings of at least MIKAMI et al., a person with ordinary skill in the art at the time this application was filed (a “POSA”) would have reasonably expected for the use of paired nickases, in the manner taught by WOLTER et al., to reduce off-target mutations such as insertions and/or deletions [lines 1-2 of claim 1]. If nothing else, the reduction in off-target mutations would have been a motivation for a POSA to select the use of a Cas9 paired nickase approach over, say, a classic Cas9 nuclease approach. Furthermore, in view of at least WOLTER et al. and MIKAMI et al., a POSA would have viewed it as an obvious design choice to select sequences that would result in nicks that are at least 20 base pairs apart from each other [last line of claim 1]. Finally, in view of at least X.LIANG et al., designing and selecting donor DNA as well as guide RNA for efficiency (including efficient introduction of the donor DNA molecule into the target region/site) would have been an obvious design choice and, if nothing else, a POSA would have been motivated to do this so that their gene editing efficiency would be optimized [claim 11].
Response to Applicant’s Remarks Dated 20February2026:
The DE VLEESSCHAUWER Declaration filed 20February2026 (hereinafter “declaration”) is acknowledged as well as the Remarks by Applicant’s representative (which reference back to the declaration).
The declaration’s material argument is with respect to the present disclosure, the accompanying claims, and MIKAMI et al. Paragraphs 13 and 14 of the declaration (copied below) sufficiently summarize the argument by Applicant, namely that what is an “on-target” or “desired” mutation within MIKAMI et al. is different that what is meant by these terms here (i.e., in these claims). For clarity, the only relevant text regarding on-target or off-target mutations within the claims is at claim 1 (the language captured below). The declaration provides Exhibit B to explain how having reduced “random insertions and/or deletions in the target region” here (in these claims) is different than what is taught or suggested by MIKAMI et al.
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Relevant portion of claim 1:
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The arguments in traverse of this rejection are not persuasive. Regarding “Mikami does not take into account homology-directed repair to generate precise edits in the target region”, this stems from the fact that MIKAMI et al. were using non-homologous end joining (NHEJ) and not Homology-Directed Repair (HDR) which flows from the fact that MIKAMI et al. were not using donor DNA. As evidenced by X.LIANG et al. at pages 136-137 (cited within the obviousness rejection) who do use donor DNA + HDR who explain that the NHEJ pathway is “error-prone, which results in disruptive insertions or deletions (indels) at targeted loci. … Alternative repair pathways include the use of … exogenous donor DNA template via components of the HDR pathway.” In particular, one begets the other: NHEJ was known in the art to cause random InDels, so artisans started using donor DNA and the HDR pathway for making precise gene edits including so-called “knock-ins” and so that random InDels could be avoided (note X.LIANG et al. refer to InDels via the NHEJ pathway as “disruptive” which would be understood to mean they may be a nuisance and/or undesirable).
Relatedly, Applicant then argues that the “desired” edits of this application are “precise edit[s] at the target region” whereas the “desired” edits in MIKAMI et al. are/were “InDel[s] at the target region” (see ¶14 of the declaration). Here again, this is a product of MIKAMI et al. using NHEJ and not donor DNA + HDR (said another way, it would not have been surprising that InDels were introduced using the methods of MIKAMI et al. because MIKAMI et al. used NHEJ—as evidenced by at least X.LIANG et al., an artisan would have known that InDels may be reduced by using a donor DNA and HDR approach). Finally, the ability to introduce “precise edits” (as opposed to InDels) is also a product of using HDR with donor DNA instead of NHEJ. It is misleading to suggest that Applicant’s “precise edit[s]” via donor DNA and the HDR pathway are sufficient to distinguish this application from MIKAMI et al.’s InDels and the rest of te prior art because MIKAMI et al. used the error-prone NHEJ pathway (not HDR).
There is no mention of X.LIANG et al. within either the declaration or the Remarks document filed 20February2026.
Arguments regarding the use of a nuclease versus a nickase have been discussed extensively of record. Here again, the declaration asserts that a POSA, in view of WOLTER, “would conclude that the use of paired nickases does not constitute an advantage, but rather a disadvantage, over the use of nucleases.” (declaration at the last sentence of ¶16).
This remains unpersuasive, especially in view of the references taken together (WOLTER et al. is not read in a vacuum). The Office’s remarks within the Advisory Action dated are relevant here and, to that end, are copied below. For context, the following remarks are in response to an argument by Applicant that MIKAMI et al. do/did not teach or suggest better efficiency with nickases versus nucleases (the arguments filed 20February2026 emphasize the teachings by WOLTER et al. and not MIKAMI et al.):
“With respect to the outstanding obviousness rejections, Applicant argues that a POSA would not have reasonably expected REDUCED undesirable mutations at the target site using a nickase (as compared to a nuclease) because, in view of MIKAMI, one such person would have thought that NUCLEASES have better on-target mutation efficiencies than do nickases.
This is not persuasive because MIKAMI does not say that nickases NEVER or CANNOT have a better on-target mutation efficiency than nucleases, just that one must carefully choose the gRNAs being used to do so. Specifically, MIKAMI say that "the on-target mutation frequency of Cas9 paired nickases depends on the design of paired gRNAs" (abstract); "on-target mutation frequency using Cas9 paired nickases varies depending on the type of overhang ... and the distance between the paired gRNAs sites ..." (left column on page 1059); "this result suggested that a combination of high performance gRNAs was necessary for efficient targeted mutagenesis using Cas9 paired nickases" (left column, page 1061); and "decreased frequency of on-target mutation is one of the concerns regarding the use of Cas9 paired nickases. In our results, differences in on-target MF between Cas9 paired nucleases and Cas9 paired nickases varied depending on the gRNA sequences used" (left column on page 1064). In view of the teachings by MIKAMI, it is maintained that a POSA would have reasonably expected
To ensure MIKAMI is providing an accurate representation of the knowledge in the art regarding what a POSA would reasonably expect regarding nickase versus nuclease on-target mutation efficiencies, a brief search was conducted and at least GOPALAPPA et al. (attached) confirm that paired nickases can have higher on-target mutation efficiencies than nucleases and GOPALAPPA et al. (a 2018 reference) evidence that this would have been known to a POSA at the time of filing and, thus, known to a POSA considering the teachings by MIKAMI.”
Claims 3, 10, 12 REMAIN rejected under 35 U.S.C. 103 as being unpatentable over WOLTER et al. (“Efficient in planta gene targeting in Arabidopsis using egg cell-specific expression of the Cas9 nuclease of Staphylococcus aureus” 2018 The Plant Journal 94:735-746; of record Form-892 19April2024) and MIKAMI et al. (“Precision Targeted Mutagenesis via Cas9 Paired Nickases in Rice” 2016 Plant Cell Physiol. 57(5):1058-1068; of record IDS 02August2024) , X.LIANG et al. (“Enhanced CRISPR/Cas9-mediated precise genome editing by improved design and delivery of gRNA, Cas9 nuclease, and donor DNA” 2017 J. Biotech. 241:136-146) as applied to claims 1, 4, 5, 11 above and SVITASHEV et al. 2015 (“Targeted Mutagenesis, Precise Gene Editing, and Site-Specific Gene Insertion in Maize Using Cas9 and Guide RNA” 2015 Plant Physiology 169:931-945) and SVITASHEV et al. 2016 (“Genome editing in maize directed by CRISPR-Cas9 ribonucleoprotein complexes” 2016 Nature Comms 7:13274, DOI:10.1038/ncomms13274, 7 total pages).
The claims filed 20February2026 are amended to remove the phrase “without any InDels …” (= overcoming the Written Description and Scope of Enablement rejections in the Nonfinal dated 20October2025). As stated at ¶6 of the Nonfinal Dated 20October2025, these Obviousness rejections of record are reinstated in view of the phrase “without any InDels …” being deleted. The rejection(s) as set forth in the Final action dated 11April2025 are copied below (which were copied from those set forth in the nonfinal action dated 22October2024). Applicant’s Remarks (20February2026) and the arguments within the De VLEESSCHAUWER Declaration (20February2026) are addressed below the rejection and within the “Response to Applicant’s Remarks” section.
↓Rejection Of record↓
The teachings of WOLTER et al., MIKAMI et al., and X.LIANG et al. as applied to claims 1, 4, 5, and 11 are described above.
Those references do not explicitly teach incubating a plant cell in medium comprising a selection agent or introducing the Cas9 nickase, sgRNA(s), and/or crRNA+tracrRNA into the cell as ribonucleoprotein (RNP) using particle bombardment.
SVITASHEV et al. 2015 demonstrate the use of selection media to identify and select edited cells (there, edited maize embryos which were selected for resistance to bialaphos treatment)7 [relevant to claim 3]. SVITASHEV et al. 2015 also discuss particle bombardment delivery and teach that, at least in certain circumstances, particle bombardment may be preferred over Agrobacterium-mediated transformation methods because particle bombardment was shown to be more efficient, likely because it “delivers multiple copies of all DNA molecules”8 [relevant to claim 12]. Further to the teachings by WOLTER et al. and MIKAMI et al. discussed above, please note that SVITASHEV et al. 2015 also mention Cas9 nickases and the fact that they had been shown to “improve specificity” of gene editing.9 Further, while SVITASHEV et al. 2015 did not use ribonucleoprotein complexes in their experiments, SVITASHEV et al. 2015 do explain that RNPs were already shown to reduce off-target mutations too10 [relevant to claim 10]. Importantly, SVITASHEV et al. 2015 specifically suggest combining a “Cas9 nickase” approach and an RNP approach to “further improve the precision and accuracy of genome editing in plants.”11
SVITASHEV et al. 2016 demonstrate successful gene editing of maize cells by particle bombardment with Cas9-gRNA RNPs12 (optionally with co-bombardment of donorDNA13) [relevant to claims 10 and 12]. SVITASHEV et al. 2016 teach that delivering RNPs showed a reduction in off-target modifications (versus delivery of DNA).14
Absent evidence to the contrary and in view of at least SVITASHEV et al. 2015, it would have been obvious to a person with ordinary skill in the art at the time this invention was filed (a “POSA”) to add a step to the technique taught by WOLTER et al. whereby transformed/bombarded cells are placed on selection media with the motivation of readily identifying/selecting the cells that were actually edited (as opposed to those cells that were not). This would have been no more than “combining prior art elements according to known methods to yield predictable results” and/or “applying a known technique (selection media) to a known method/product (that taught by WOLTERS et al.) ready for improvement to yield predictable results” MPEP § 2143(I)(A), (D). Further, in view of at least SVITASHEV et al. 2015 and SVITASHEV et al. 2016, it would have been obvious to a POSA that the delivery technique used by WOLTERS et al. may be substituted for RNP delivery by particle bombardment and with the motivation of further reducing off-target modifications (as discussed by SVITASHEV et al. 2016). This would have been no more than the “simple substitution of one known element (RNP delivery by particle bombardment) for another (Agrobacterium-mediated transformation) and/or “applying a known technique (RNP delivery by particle bombardment) to a known method/product (that taught by WOLTERS et al.) ready for improvement to yield predictable results” MPEP § 2143(I)(B), (D).
Response to Applicant’s Remarks Dated 20February2026:
Applicant asserts that the arguments set forth with respect to the rejection above are sufficient overcome this rejection.
Those are not persuasive for the reasons stated above.
Claim 13 REMAINS rejected under 35 U.S.C. 103 as being unpatentable over WOLTER et al. (“Efficient in planta gene targeting in Arabidopsis using egg cell-specific expression of the Cas9 nuclease of Staphylococcus aureus” 2018 The Plant Journal 94:735-746; of record Form-892 19April2024) and MIKAMI et al. (“Precision Targeted Mutagenesis via Cas9 Paired Nickases in Rice” 2016 Plant Cell Physiol. 57(5):1058-1068; of record IDS 02August2024) , X.LIANG et al. (“Enhanced CRISPR/Cas9-mediated precise genome editing by improved design and delivery of gRNA, Cas9 nuclease, and donor DNA” 2017 J. Biotech. 241:136-146) as applied to claims 1, 4, 5, 11 above and BELHAJ et al. (“Plant genome editing made easy: targeted mutagenesis in model and crop plants using the CRISPR/Cas system” 2013 Plant Methods 9(39), 10 total pages).
The claims filed 20February2026 are amended to remove the phrase “without any InDels …” (= overcoming the Written Description and Scope of Enablement rejections in the Nonfinal dated 20October2025). As stated at ¶6 of the Nonfinal Dated 20October2025, these Obviousness rejections of record are reinstated in view of the phrase “without any InDels …” being deleted. The rejection(s) as set forth in the Final action dated 11April2025 are copied below (which were copied from those set forth in the nonfinal action dated 22October2024). Applicant’s Remarks (20February2026) and the arguments within the De VLEESSCHAUWER Declaration (20February2026) are addressed below the rejection and within the “Response to Applicant’s Remarks” section.
↓Rejection Of record↓
The teachings of WOLTER et al., MIKAMI et al., and X.LIANG et al. as applied to claims 1, 4, 5, and 11 are described above.
Those references do not explicitly teach adding a nuclear localization signal (NLS) to the Cas9 nickase (“RNA guided nickase”).
BELHAJ et al. demonstrate fusing an NLS to the Cas9 for the purpose of ensuring the Cas9 is delivered into the nuclei of the plant cell15 [relevant to claim 13].
Absent evidence to the contrary, it would have been obvious to a person with ordinary skill in the art at the time this application was filed (a “POSA”) to modify the technique of WOLTER et al. by fusing an NLS to the Cas9 nickase sequence to, like BELHAJ et al., ensure that it is delivered into the nuclei of the plant cell. This would have been no more than the “use of [a] known technique to improve similar methods/products in the same way” and/or “applying a known technique (the use of NLSes) to a known method/product (that taught by WOLTERS et al.) ready for improvement to yield predictable results” MPEP § 2143(I)(C), (D).
Response to Applicant’s Remarks Dated 20February2026:
Applicant asserts that the arguments set forth with respect to the rejection above are sufficient overcome this rejection.
Those are not persuasive for the reasons stated above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-5, 10-13 REMAIN provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 17785358 (US 2023/0220405; Attny. Dkt. No. 03961.00938). Although the claims at issue are not identical, they are not patentably distinct from each other. Notably, the only material difference between the claims appears to be that the claims of 17785358 are limited to wheat plants/cells whereas the claims of this application encompass any plant/plant cell. To that end, the claims of 17785358 are a species within the genus claims of this application and, therefore, the examined claims of this application are anticipated by, or would be obvious over, the claims of 17785358.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Remarks:
Applicant says that they will address this provisional rejection in the event a Notice of Allowability is mailed.
Conclusion
[Copied from the Nonfinal Dated 20October2025 →] In the interest of transparency and conservation (of both temporal and monetary assets), please note that the Office has not identified a path toward patentability for the examined claims.
THIS ACTION IS MADE FINAL. 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 Rebecca STEPHENS whose telephone number is (571)272-0070. The examiner can normally be reached Monday through Friday 8:30-4:30.
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/REBECCA STEPHENS/Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
1 WOLTERS et al. at page 737 including Figure 1.
2 See the Abstract of MIKAMI et al. as well as the paragraph bridging pages 1058-1059, right column of pages 1061 and 1063, compare Figures 3 and 4.
3 See Table 1 on page 1062 of MIKAMI et al. and, for example, the discussion at the left column of page 1064 regarding “AB4t + AB3b” where the distance between the two nicks was 37 base pairs and (per Table 1) the distance between the two paired gRNAs was also 37 base pairs.
4 See the Abstract of X.LIANG et al. at page 136.
5 See pages 140-141 (sections 3.3 and 3.4) of X.LIANG et al.; see also Discussion section 4 at pages 144-145.
6 See pages 141-144 (section 3.5) and Figure 5 of X.LIANG et al. ; see also Discussion section 4 at pages 144-145.
7 SVITASHEV et al. 2015 at page 933, right column on page 936,
8 SVITASHEV et al. 2015 at the left column on page 941.
9 SVITASHEV et al. 2015 at the right column on page 941.
10 SVITASHEV et al. 2015 at the right column on page 941.
11 SVITASHEV et al. 2015 at the right column on page 941.
12 SVITASHEV et al. 2016 at the right column on page 2 to the right column on page 3.
13 See SVITASHEV et al. 2016 at the right column on page 3.
14 SVITASHEV et al. 2016 at the left column on page 3.
15 BELHAJ et al. at the right column on page 3, Figure 2 on page 5.
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