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
Applicant’s election of Group II in the reply filed on 28 July 2026 is acknowledged.
Claims 1-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 28 July 2026.
Claim Status
Claims 1-21 are pending.
Claims 1-8 are withdrawn from consideration.
Claims 9-21 are examined on the merits.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 15-21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Labs et al (WO2019122394 A2) which claims priority to US Provisional 62/609,508 filed 22 December 2017.
Labs et al disclose in claims 29-40 methods of modifying the genome of a cell that uses a synthetic transcription factor that increases expression of a morphogenic factor (including Wuschel and Babyboom which are contemplated to improve regeneration capacity of transgenic calli), a site-specific nuclease that creates a double strand break (including Cas endonucleases p. 47, 49), and a polynucleotide of interest (which can confer the some of the beneficial traits listed in 19 and 21; p. 65-66) to be inserted which may be flanked by homology domains, making it a donor/template (Claims 29, 36, 39). Accordingly, claims 15-21 is/are rejected as being anticipated by Labs et al.
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.
Claims 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shi et al (WO 2016/007948 A1).
The claims are drawn to the methods of modifying target cells using Cas endonucleases and morphogenic factors wherein the elements are provided on different constructs, wherein the morphogenic factor is provided as upregulation of an endogenous gene, wherein the Cas endonuclease and or guide RNA are provided within the T-DNA borders and the morphogenic factor is provided outside the T-DNA borders.
Shi et al disclose that use of double strand break inducing agents including Cas and donor DNA being provided to a cell on plasmids while being co-bombarded with ODP2 and Wus. They further teach that transiently providing BBM and/or Wus2 can be used to enhance transformation by kickstarting callous growth and regenerations of plants (Examples 1-7). They also teach use of modification templates to alter an agronomic trait including fertility and abiotic stress response (claims 36-43). Accordingly, claims 1-2 and 16-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shi et al.
Shi et al do not teach these methods for providing the morphogenic factor.
At the time of filing, it would have been prima facie obvious to a person of ordinary skill in the art provide a morphogenic factor in a number of ways and each would have potential advantages and disadvantages that would have been apparent to a person of ordinary skill in the art. One obvious design choice would have been to provide the morphogenic factor and the Cas gene on the same construct which would eliminate the need for co-bombardment, thus potentially increasing transformation efficiency. The drawback would be that the morphogenic factor would need to be placed on the construct such that it is transiently provided. One solution would be to place this outside the T-DNA borders if Agrobacterium transformation is being used, because only DNA within the borders gets integrated into the target genome. Such a construct design would have been apparent to a person ordinary skill in the art at the time of invention. Another possibility is that the morphogenic factor is provided transiently via upregulation of an endogenous gene. Methods of increasing expression of endogenous genes were well known in the art at the time of invention (such as activator domains fused to engineered zinc fingers or TALs) and the Examiner is taking official notice as to this point. As such, claims 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shi et al.
Claim 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shi et al (WO 2016/007948 A1) as applied to claims 1-2 and 16-21 above and further in view of Ziemienowicz et al 2015 (Cell-Penetrating Peptides: Methods and Protocols, Methods in Molecular Biology 1324).
The claims are drawn to the method of claim 9, wherein the morphogenic factor is provided as protein or wherein the Cas endonuclease and/or morphogenic factor is fused to a cell penetrating peptide.
Shi et al teach all the limitations of claim 9.
Shi et al do not teach to deliver the composition(s) as peptides.
Ziemienowicz et al teach that the use of cell penetrating peptides to provide protein to a plant cell (Section 4.4).
At the time of filing, it would have been prima facie obvious to a person of ordinary skill in the art to provide the morphogenic factor as a protein to a plant and that the use of a CPP would aid in delivery of the protein into the target plant cell. A person of ordinary skill would have been motivated to provide the morphogenic factor as a protein as a protein, because there would be no concern that the morphogenic factor encoding DNA would unintentionally be incorporated in the target cell. As such, claims 11-13is/are rejected under 35 U.S.C. 103 as being obvious.
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.
Claim 9-11 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11332752. Although the claims at issue are not identical, they are not patentably distinct from each other, because instant claim 14 shares the same feature of the copending claims which is the basis of patentability of the copending claims (i.e. the use of a Cas-repressor fusion outside of the T-DNA borders. Claims 9-11 are included in the rejection, because they encompass the subject matter of claim 14.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
