CTNF 18/480,381 CTNF 91732 Notice of Pre-AIA or AIA Status 07-03-fti AIA The present application is being examined under the pre-AIA first to invent provisions. Status of the Claims The status of the claims dated 26 March 2025, is as follows: Claims 1, 4-6, 30-31 and 33-36 are pending. Claims 1, 4-6, 30-31, 33 and 36 have been amended. 12-151-10 AIA 12-51-10 Claim s 2-3, 7-29 and 32 have been canceled. Claims 5-6, 31 and 33-36 have been withdrawn. Claims 1, 4 and 30 have hereby examined. Response to the Restriction Requirement 08-11 AIA A Requirement for Restriction was sent out on 4 February 2026. Applicant was required to choose a single invention. Applicant responded on 27 March 2026 and elected Group I , claim s 1, 4 and 30 drawn to a container pressurized to at least 227 atm classified in A47J31/24, for example . 08-25-02 Applicant’s election of Claims 1, 4 and 30 in the reply filed on 4 February 2026 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)). Withdrawn Rejections The rejection of claims 5-6, 31 and 33-36 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends has been withdrawn in light of the amendments dated 26 March 2025. The rejection of claims 1, 4-6, 30-31 and 33-36 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or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement has been withdrawn in light of the amendments dated 26 March 2025. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-fti The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made. 07-23-fti The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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. 07-20-02-fti This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a). 07-21-fti Claim s 1, 4 and 30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Martinell et al. (US 2009/0138985; May 28, 2009); Ting-Kuo et al (2009. Bioreactor engineering for recombinant protein production in plant cell suspension cultures. Biochemical Engineering Journal 45:168-184); Oneto et al. (2010. High and low pressure gene gun devices give similar transformation efficiencies in maize calluses. African Journal of Plant Sciences 4: 217-225) and Lowe et al. (2009. Enhanced single copy integration events in corn via particle bombardment using low quantities of DNA. Transgenic Res. 18: 831-840) . The claims are broadly drawn to container pressurized to at least 227 atm comprising a purified population of dry mature corn seed explants competent for genetic transformation, wherein the explants are comprised of the apical portion of the embryo axis lacking the radical, wherein the remaining portions of the corn seed have been substantially removed from the explants, wherein the explants have an internal moisture content of 7.4% to 10.2% and wherein the explants are produced from a corn seed with an internal moisture content of 3% to 25%. The claims are drawn to a method of producing a container pressurized to at least 227 atm comprising the population comprised in the pressurized container, the method comprising crushing or grinding a surface of a population of corn seeds, removing unnecessary seed parts from the explant and pressurizing the container comprising the explants to at least 227 atm. The claims are further drawn to wherein the embryo axis is defined as comprising the plumule, coleoptile, mesocotyl, and at least a portion of the scutellar node of a corn seed. Martinell et al teach methods and compositions for transforming soybean, corn , cotton, or canola explants [abstract]. Martinell et al teach that 20 to 25 embryos (which reads on dry mature corn seed explants competent for genetic transformation ) are transferred onto a modified MS medium with spectinomycin [0129]. Martinell et al teach that the invention provided methods and compositions for preparing , screening, transforming, and regenerating explants from soybean, corn , cotton, or canola plants to obtain transformed plants [0028]. Martinell et al also teach that the explant tissue is chosen from meristem , immature embryo, embryo, embryonic axis, cotyledon , hypocotyl, mesocotyl, leaf, primary leaf base, leaf disc, shoot tip, and plumule [0019]. A dry seed or an explant may be first primed, redried and later used for transformation and regeneration [0045]. An explant such as an immature or mature embryo [0029], dry explants or dried wet explants of various ages are suitable [0044]. Martinell et al teach conditions wherein the explant has an internal moisture content of from about 3% to about 25% (which reads on wherein the explants have an internal moisture content of 7.4% to 10.2% ) [0016]. The explant is further defined as having been excised from a seed comprising 3% to 25% internal moisture content (which reads on wherein explants are produced from a corn seed with an internal moisture content of 3% to 25% ) [0019]. Martinell et al also teach that explants may be recovered from dry storable seed [0047]. Martinell et al teach that immature embryos are directly fropped into the prepared Agrobacterium cell suspension in 1.5 mL microcentrifuge tube (which reads on a container pressurized to atmospheric pressure (1 atm)) [0127]. Martinell et al teach that a method was developed to stimulate the metabolic activity of the dry excised explants prior to Agrobacterium inoculation, for increasing their transformation competency [0140]. By manipulating the biology of the dry explant, it is possible to increase % germline positive events per explant by 2 to 10-fold. The transformation frequencies obtained using the methods and compositions described herein are increase over those found in the prior art by 2-10 or 5-10-fold (and even higher in some cases) [0031]. Furthermore, combined with an increased transformation efficiency, the methods described also allow for more rapid regeneration of candidate transformed plant tissues, increased efficiency in identifying and growing transformed shoots and plants and reduced costs and ergonomic burden, while simplifying and reducing the labor necessary to produce transformed plants [0032]. Although Martinell et al do not specifically state wherein the explant is comprised of the apical portion of the embryo axis lacking the radicle, Martinell et al teach using explant tissue from the meristem, cotyledon or the plumule. It would naturally follow that these tissues do not contain the radicle or other parts of the embryo or seed. Martinell et al teach using dry explants [page 4, para. 0044] and corn [abstract]. Martinell et al further teach using tissue including meristem, cotyledon and plumule [para 0019]. Therefore, it would be obvious to use the explant material, including dry corn explants derived from the cotyledons, meristem and plumule as taught by Martinell et al which would have encompassed the explant comprising the apical portion of the embryo axis lacking the radicle. One would have been motivated to use the apical portion of the embryo axis lacking the radicle given the success of Martinell et al in producing multiple buds and regenerating transgenic plants using this type of tissue. Although Martinell et al do not specifically state wherein at least a first explant in said population is produced by grinding of the surface of a corn seed, Martinell et al teach screening of transformable meristematic explant material from non-transformable damaged explants, cotyledons, seed coats and other debris [00514]. Bulk yield of crushed seed that has been passed through the rollers may be put through a series of separation sieves [0051]. One of ordinary skill in the art would understand that the rollers, while crushing the seeds, also grind the seeds between the rollers and other seeds, seed parts and seed debris and that the separation sieves remove unnecessary seed parts . Martinell et al do not teach that the container is pressurized to at least 227 atm. Ting-Kuo et al. teach a plurality of containers used for various plant cell growth experiments. Ting-Kuo et al teach that these containers (bioreactors) must provide an environment that is able to optimize the growth and productivity of the genetically engineered cells [page 177, left col., para.3]. Ting-Kuo teach that the pressure of the containers may be increased depending on the desired outcome [page 177, rt. col., para 2]. Oneto et al teach the use of biolistic transformation at high and low pressure to increase transformation efficiencies in maize calluses. Oneto et al. used a number of different pressures ranging from 87 psi (6 atm) to 1100 psi (74 atm). Oneto et al teach that the PDS 1000 He™ (Bio Rad) pressure range commonly used is between 300 and 2000 psi (20 to 137 atm). Lowe et al teach using biolistic pressure to consistently yield single copy events at higher frequencies at lower cassette DNA load as compared to higher cassette DNA load in corn (paragraph bridging pages 831-832). The use of the PDS 100 He™ demonstrates the flexibility of this method for controlling the frequency of production of either low copy or high copy events by altering the quantity of cassette DNA (paragraph bridging pages 831-832). It would have been obvious to one of ordinary skill before the effective filing date to combine the teachings of Ting-Kuo, Oneto et al and Lowe et al to pressurized a container for genetic transformation. Ting-Kuo et al. teach a plurality of containers, including pressurizing the containers, for various plant cell growth for recombinant protein production, which underlies plant transformation. Both Oneto et al and Lowe et al teach using biolistic transformation using high pressure to get insertion of the DNA into corn cells. One would have had a reasonable expectation of success given the historic success of biolistic transformation in the art and as taught by Oneto et al. and Lowe et al using corn plant cells. One would have been motivated to combine the teachings to produce a container capable of using high pressure for genetic transformation because the use of high pressure, such as the biolistic transformation, has proven to produce consist results and increase transformation efficiencies. Furthermore, contained pressure would decrease the loss of DNA material due to spray outside the target area and would concentrate the DNA material around the target plant material thus increasing the exposed surface area. It would have been obvious to one of ordinary skill before the effective filing date, to combine the teachings of Ting-Kuo et al., Oneto et al. and Lowe et al. to pressurize the container for genetic transformation that contains the purified population of dry mature corn seed explants competent for genetic transformation as taught by Martinell et al. Martinell et al teach explants in a pressurized (atmospheric pressure) container comprised of the apical portion of the embryo axis lacking the radical that have an internal moisture content of 7.4% to 10.2% that were produced from a corn seed with an internal moisture content of 5% to 25%. The pressure container of Ting-Kuo et al. and the teachings of Oneto et al. and Lowe et al. using high pressure to introduce DNA into corn plants cells provides the motivation to use a container that is highly pressurized to get insertion of the DNA into the corn cells. One would have been motivated to combine the teachings because the use of high pressure, such as the biolistic transformation, has proven to produce consist results and increase transformation efficiencies resulting in increased transformation of the corn explants. Furthermore, contained pressure would decrease the loss of DNA material due to spray outside the purified population of dry mature corn seed explants competent for genetic transformation and would concentrate the DNA material around the corn explants thus increasing the exposed surface area. Although the cited references do not teach pressures to at least 227 atm, one skilled in the art at the time the invention was made would have been motivated to use such high pressure as a matter of routine optimization and experimentation. The adjustment of particular conventional working parameters such as pressure in the container is deemed to be merely a matter of selection and routine optimization that is well within the purview of the skilled artisan. Accordingly, this type of modification would have been no more than an effort to optimize results. In the absence of any showing of criticality or unexpected results, the particular pressure is an obvious variation of what was taught in the prior art and could be arrived at during routine experimentation/optimization. Additionally, it would have been obvious to use such a pressure to increase transformation efficiencies and decrease the amount of DNA load needed to obtain the desired results. Furthermore, the amount of pressure applied to the container is merely a design choice. Applicants Arguments dated 26 March 2025 Applicants urge that the cited prior art does not teach or suggest at least the feature of a pressurized container pressurized to at least 227 atm comprising a purified population of dry mature corn seed explants competent for genetic transformation (claim1). These arguments have been carefully considered but are not deemed persuasive. The rejection of the newly amended claims is now addressed supra. Applicants urge that the non-obviousness of the present claims is demonstrated by the unexpected results yielded by the claimed invention. Corn seed explants having this optimal internal moisture content regenerated corn plants at an average frequency of 64% compared to lower regeneration frequencies obtained with corn seed explants having an internal moisture content of 10.3% to 22%. 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., significant increase in transfection) are not recited in the rejected claim(s). 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). Conclusion No claim is allowed. Contact information Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN M REDDEN whose telephone number is (571)270-0298. The examiner can normally be reached 730-6 Monday-Thursday. 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, Shubo (Joe) Zhou can be reached on (571) 272-0724. 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 USPT O Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KAREN M REDDEN/Primary Examiner, Art Unit 1661 Application/Control Number: 18/480,381 Page 2 Art Unit: 1661 Application/Control Number: 18/480,381 Page 3 Art Unit: 1661 Application/Control Number: 18/480,381 Page 4 Art Unit: 1661 Application/Control Number: 18/480,381 Page 5 Art Unit: 1661 Application/Control Number: 18/480,381 Page 6 Art Unit: 1661 Application/Control Number: 18/480,381 Page 7 Art Unit: 1661
Prosecution Insights