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 .
Status of Claims
Claims 1, 3, 7-8, 14, and 16-19 are pending and are examined in this office action.
Claims 1, 3 are currently amended.
Claims 16-19 are newly presented.
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
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:
Claim(s) 1, 3, 5, 7-8, and 14 remain rejected and claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Hummel et al (WO2019/122394A2) and further in view of Lowe et al 2016 (The Plant Cell 28: p.1998-2015) and Gordon-Kamm et al (US 9765352 B2).
Hummel et al teach methods of modifying genetic material of plant cell comprising introducing into the plant cells: a synthetic transcription factor that activates expression of morphogenic factor including BBM and wuschel, a site-specific nuclease to induce a double strand break at a target site, a nucleotide of interest flanked by homology sequences (donor), assaying for the presence of the modification (claims 1-40). They additionally teach that the site-specific nuclease can be CRISPR/Cas (p. 70-71), selectable markers and/or sequencing are among the techniques that can be used for confirming transformation/modification (p. 95), that maize BBM and WUS can be used to induce embryogenesis in tissues including leaves (Example 5). They additionally point to the teachings of Lowe et al and state that the Lowe et al teach that expression of BBM and WUS2 can be used to achieve high levels of transformation of previously untransformable inbred maize lines.
Looking to Lowe et al at the suggestion of Hummel et al, a person of ordinary skill in the art that Lowe et al teach that historically, monocot transformation required the use of immature embryos which are often more that limited in amount and availability than other plant tissues (Introduction).
Gordon-Kamm et al teach several methods for controlled expression of BBM and WUS2 morphogenes including methods using stable transformation of constructs comprising inducible promoter systems regulating expression of BBM (AP2 family with two AP2 domains) and WUS2 (WUS/WOX family member) (See examples, especially example 6).
At the time of filing, it would have been prima facie obvious to a person of ordinary skill in the art to practice the methods of Hummel et al using maize leaves as a starting material. A person of ordinary skill in the art would have been motivated to do so given the teachings of Lowe et al regarding the comparative easy accessibility of maize leaf explants. Further, a person of ordinary skill in the art would have recognized that alternative means for increased expression of BBM and WUS2 were known in the art including the method taught by Gordon-Kamm et al which uses stable transformation of constructs comprising inducible promoter systems regulating expression of BBM and WUS2. Thus, the alternative means would have been viewed as a design choice compared to the use of synthetic transcription factor to induce expression of BBM and WUS2 as is taught by Hummel et al. Accordingly, claims 1, 3, 5, 7-8, 14, 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hummel et al and further in view of Lowe et al and Gordon-Kamm.
Response to Arguments - Claim Rejections - 35 USC § 103
Applicant's arguments filed 27 July 2026 have been fully considered but they are not persuasive.
Applicant argues that the prior art does not teach to provide the morphogenic factors prior to transformation while Hummel teaches co-delivery of a mechanism to increase morphogenic expression at the time of transformation. Applicant also points to Example 5 of the instant specification which pre-transformation of leaf cells with the morphogenic factor led to targeted modification in 3/142 transgenic events, whereas no targeted modifications were observed without increase of expression of morphogenic factors.
This argument is not persuasive, because absent evidence to the contrary, pre-transformation and co-delivery would have been apparent obvious variants of one another. It would seem that as long as increase in morphogenic gene activity occurred while the nucleases were being expressed that the improved targeting efficiencies would likely be observed. Example 5 in no way indicates that pre-transformation is superior to co-delivery, because the control in example 5 is no morphogenic factor. Data demonstrating that pre-transformation is superior to co-delivery of the same morphogenic factors may support a finding of non-obviousness.
Applicant is reminded that the evidence of nonobviousness should be commensurate with the scope of the claims. See In re Lindner, 173 USPQ 356 (CCPA 1972) and In re Grasselli, 218 USPQ 769 (Fed. Cir. 1983).
Conclusion
No claims are allowed. 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 extension fee 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 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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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
