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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 13 February 2026 has been entered.
Status of Claims
Claims 1, 3, 5, 7-8, and 13-15 are pending and are examined in this office action.
Claims 1, 3, and 5 are currently amended.
Claims 13-15 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 10-11 remain rejected and claims 13-14 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 additional 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 and WUS2 (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, 10-11, and 13-14 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 13 February 2026 have been fully considered but they are not persuasive.
Applicant’s arguments can be summarized into three simple lines of argument:
The references of Lowe, Gordon-Kamm, and Jones do not relate to homology-dependent genome modification. This amounts to a piecemeal argument (see below), especially given that Hummel already connected the dots between homology-dependent genome modification and Babyboom and Wuschel2 when they cite Lowe. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The references do not teach a two-stage morphogenic factor and recovery of homology-dependent targeted modification a somatic cell. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a two-stage morphogenic exposure and recovery of homology-dependent targeted modification a somatic cell) are not recited in the rejected claim(s). Given the most recent claim amendments, there is nothing in the claims that speaks to the timing by which the steps of claim must occur. In fact, there is nothing in the claims that preclude the first and second morphogenic factors from being introduced simultaneously. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Hummel relates to upregulation of endogenous morphogenic factors rather than exposure to exogenous morphogenic factors. This is not persuasive, because both processes lead to the cells producing more Babyboom and Wuschel proteins. The origin of the Babyboom and Wuschel proteins should not matter as long as they are present. Thus, the Office holds that upregulation of endogenous morphogenic factors or exogenously supplied morphogenic factors are obvious variants of one another absent any evidence to the contrary.
Claim Rejections - 35 USC § 112
Lack of Written Description
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 15 is drawn to a method of obtaining a genetically modified plant of any species that starts with a somatic cell from leaf tissue, modifying the genome, obtaining an embryogenic cell from the somatic cell, and regenerating a plant from the somatic cell without a callus phase.
The instant disclosure only describes examples from maize. Examples 1-5 are indicated as having been reduced to practice while examples 6-7 are prophetic. Example 5 is most pertinent to the instant claim as it uses leaf tissue as a starting material, but the regeneration has a callus phase.
The prior art of Lowe 2018 (In Vitro Cellular & Developmental Biology 54: p. 240-252; note that this publication shares authors with the current list of inventors for the instant application) state that direct somatic embryogenesis was not observed in maize when using leaf segments or mature embryos as starting tissue, instead an embryogenic callus phase of 2-3 weeks occurred before plants began to regenerate (p. 245).
These descriptions are insufficient, because they fail to describe any occurrence of direct embryogenesis when starting with leaf tissue.
Given the broad scope of the claimed genus, the lack of working examples and the failure to describe the structures required to confer the claimed function, one of skill in the art would not have recognized that Applicant was in possession of the claimed genus at the time of filing.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663