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 .
DETAILED ACTION
Status of objections and rejections
1. Claims 1-29 are pending. Claims 15-29 are previously withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Accordingly, Claims 1-14 are examined on merits in this Office action. Applicant’s response filed May 21, 2026 is entered.
2. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
3. Rejection of Claims 1-6, 10 and 12 under 35 U.S.C. 103 as being unpatentable over Martin-Ortigosa et al. (WO 2016/184989 A1, published Nov. 24, 2016) is withdrawn in light of claim amendments filed in the papers of May 21, 206 and upon further consideration. However, Applicant’s claim amendments filed in the papers of May 21, 2026 has necessitated new rejection. See item 8 below in the Office action.
4. Rejection of Claim(s) 1-13 under 35 U.S.C. 103 as being unpatentable over Martin-Ortigosa et al. (WIPO, WO 2016/184989 A1, Published November 24, 2016), and further in view of Zhu et al. (Molecular Cell Biology, 21:661-677, Published 2020) is withdrawn in light of claim amendments filed in the papers of May 21, 206 and upon further consideration. However, Applicant’s claim amendments filed in the papers of May 21, 2026 has necessitated new rejection. See item 9 below in the Office action.
5. Rejection of Claim(s) 1-14 under 35 U.S.C. 103 as being unpatentable over Martin-Ortigosa et al. (WIPO, WO 2016/184989 A1, Published November 24, 2016), in view of Zhu et al. (Molecular Cell Biology, 21:661-677, Published 2020) and further in view of Yin et al. (Sci Rep., 5:1038/srep14926, pp 1- 10, 2015) is withdrawn in light of claim amendments filed in the papers of May 21, 206 and upon further consideration. However, Applicant’s claim amendments filed in the papers of May 21, 2026 has necessitated new rejection. See item 10 below in the Office action.
6. Rejection of Claim(s) 1-14 under 35 U.S.C. 103 as being unpatentable over Martin-Ortigosa et al. (WIPO, WO 2016/184989 A1, Published November 24, 2016), in view of Zhu et al. (Molecular Cell Biology, 21:661-677, Published 2020) and further in view of Alghuthaymi et al. (Int. J Mol Sci., 22(14),7456, pages 1-22, July 2021) is withdrawn in light of claim amendments filed in the papers of May 21, 206 and upon further consideration. However, Applicant’s claim amendments filed in the papers of May 21, 2026 has necessitated new rejection. See item 11 below in the Office action.
Claim Rejections - 35 USC § 112
7. Claims 1-14 remain rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention for the reasons of record stated in the Office action mailed November 21, 2025.
Applicant traverses the rejection in the papers filed May 21, 2026.
Applicant’s arguments have been fully considered but are not persuasive.
Applicant argues that amended claim 1 is directed to a method of genome editing in an explant at a particular developmental stage and not to Cas proteins, guide RNAs, plants, or genome editing reagents themselves. Applicant further argues that CRISPR/Cas components, guide RNAs, and delivery systems were well known in the art and that the inventive aspect of the claims resides in targeting shoot apical meristem tissue in germinated seeds at a conserved developmental stage. Applicant additionally relies upon Teva Pharms. Int’l GmbH v. Eli Lilly & Co., No. 24-1094, for the proposition that claims directed to methods using known biological materials do not require disclosure of an entire genus of such materials.
The Office acknowledges that CRISPR/Cas systems, guide RNA design, and certain delivery systems were known in the art at the time of filing. The Examiner further acknowledges that the specification describes genome editing experiments involving Sorghum bicolor expressing Cas9 and guide RNAs targeting GFP and bmr6 loci. However, the pending claims are not limited to the specific embodiments exemplified in the specification.
As presently drafted, the claims encompass methods employing any Cas protein, any guide RNA, any target locus, numerous plant types including monocotyledonous and dicotyledonous plants of varying ploidy, and multiple delivery systems including vacuum infiltration, bombardment, Agrobacterium-mediated transfer, viral-mediated transfer, vectors, and carbon nanotubes. The claims additionally encompass multiplex genome editing and selectable editing outcomes. The breadth of the claims therefore extends substantially beyond the limited embodiments disclosed in the specification.
The specification provides only a limited number of representative working examples involving Cas9-mediated editing in Sorghum using a small number of guide RNAs and primarily carbon nanotube delivery. The specification does not describe a representative number of species spanning the full scope of the claimed methods, nor does it identify common structural or methodological features sufficient to demonstrate possession of the entire claimed genus of methods at the time of filing.
Applicant’s reliance on Teva is not persuasive. In Teva, the claims were directed to the use of a known and well-characterized class of antibodies having established functional properties in the art. In contrast, the presently claimed methods encompass a broad range of genome editing systems, guide RNAs, delivery modalities, plant classes, and editing contexts that are not sufficiently characterized in the specification. The present claims therefore extend beyond the specific embodiments disclosed and beyond what the specification reasonably conveys as being in Applicant’s possession at the time of filing.
Applicant additionally argues that the claimed invention resides in targeting the shoot apical meristem at a conserved developmental stage across plants. While the Office acknowledges that shoot apical meristem tissue and germination stages may be conserved biological features, the claims are not limited solely to the developmental-stage aspect of the method. Rather, the claims broadly encompass numerous genome editing implementations and reagent systems whose applicability across the full claimed scope is not adequately described in the specification.
The Declaration submitted by co-inventor Albert P. Kausch has been considered but is likewise not persuasive. Although the Declaration states that shoot apical meristem tissue is evolutionarily conserved across plants, the Declaration does not cure the lack of written description support for the full breadth of the claimed genome editing methods employing diverse Cas proteins, guide RNAs, plant systems, delivery approaches, and editing configurations encompassed by the claims.
Also see in re Curtis (69 USPQ2d 1274 (Fed. Cir.2004), where the court held that there was sufficient evidence to indicate that one of ordinary skill in the art could not predict the operability of other species other that the single one disclosed in the specification. The court held that a disclosure naming a single species can support a claim to a genus that includes that species if a person of ordinary skill in the art, reading the initial disclosure, would “instantly recall” additional species of the genus already “stored” in the minds, but if other members of the genus would not “naturally occur” to a person of ordinary skill upon reading the disclosure, then unpredictability in performance of species other than specifically enumerated defeats claims to the genus.
Accordingly, the specification does not reasonably convey to one of ordinary skill in the art that Applicant had possession of the full scope of the claimed invention at the time of filing. Therefore, the rejection of claims 1-14 under 35 U.S.C. 112(a) for lack of adequate written description is maintained.
In view of above, the requirement for written description has not been met.
Claim Rejections - 35 USC § 103
8. Claims 1-6, 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Martin-Ortigosa et al. (WO 2016/184989 A1, published Nov. 24, 2016) in view of Sairam et al. (Genome, 46(2):323-329, 2003) and further in view of Galán-Ávila et al., (Frontiers in Plant Science 11:645, pages 1-15, 2020 doi: 10.3389/fpls.2020.00645). This rejection has been necessitated due to claim amendments filed in the papers of May 21, 2026.
Martin-Ortigosa et al. teach a method of genome editing in an plant explant and subsequently obtaining a transgenic plant, wherein the method comprises a plant transformation vector using CRISPR/Cas9 based system in targeting an endogenous plant gene to suppress or eliminate its expression in plant cells and transformed plants obtained thereof. The method comprised non-naturally occurring CRISPR/Cas9 based gene editing system incorporated into a plant transformation vector. The transformed plant cells present within transformed plant expressed a DNA molecule having a target sequence and encoding gene of interest. The reference further teach that Cas9 protein expresses in the transformed plant. The reference discloses targeting shoot meristems in plant explants. The reference teach that after approximately 4 days the apical shoot apices were excised from distal part of the first internode of the epicotyl and coleoptile was removed. The reference further discloses that once the meristem was exposed the in planta (in vivo) delivery methods like particle bombardment, microinjection were used deliver gRNA sequences within the cells of transformed plant expressing CRISPR/Cas9 protein. The reference further teaches that the transgenic plant is a monocotyledonous or dicotyledonous plant species.
It may be noted that the reference teaches through several examples in many economically important plant crop species, methods of genome editing which also includes altering expression of at least one gene product comprising transforming plant with a plant transformation vector using CRISPR/Cas9 based system in targeting an endogenous plant gene to suppress or eliminate its expression in plant cells and transformed plants obtained thereof. The method comprised non-naturally occurring CRISPR/Cas9 based gene editing system incorporated into a plant transformation vector. The transformed plant cells present within transformed plant expressed a DNA molecule having a target sequence and encoding gene of interest. The reference further discloses that said method comprising: (a) a first regulatory element (promoter) operable in a plant cell and operably linked to at least one nucleotide sequence encoding a CRISPR-Cas system guide RNA (gRNA) that hybridizes with the target sequence, and (b) a second regulatory element operable in a plant cell and operably linked to a nucleotide sequence encoding a Type-ll CRISPR- associated nuclease (Cas9), wherein components (a) and (b) were located on same plant transformation vector of the system or on different plant transformation vector delivery system. For example, a transgenic plant expressing Cas9 protein is further transformed in vivo (in planta) with genome editing agent gRNA that was previously designed to specifically target endogenous plant gene of interest. The reference further teaches that the guide RNA targeted the target sequence and the CRISPR-associated nuclease (Cas9) cleaved the DNA molecule, and whereby expression of the gene product is altered, resulting to expected phenotype to the transformed plant. The reference further teaches that the CRISPR- associated nuclease and the guide RNA do not naturally occur together. The reference further disclose that nucleotide encoding said guide RNA and nucleotide sequence encoding said CRISPR-associated nuclease are also operably linked to a terminator at 3’ end to terminate transcription. The reference also teaches using cold pretreatment to meristem tissues prior to treating with said editing solution using said particle bombardment or other in vivo or in planta delivery systems. See in particular, examples 1-13 at pages 45-75, including plant transformation and in vivo/planta delivery methods of editing agent gRNAs, Figures 1-7.
Martin-Ortigosa et al. do not specifically teach (i) bridge transgenic plant/bridge intermediate transgenic, or germinating seeds expressing Cas protein and using explants derived from said germinated seed to do genome editing using gRNA and (ii) Martin-Ortigosa et al. also do not expressly teach obtaining germinated seeds at an early developmental stage in which the radicle has emerged and the epicotyl has not or has only minimally emerged, followed by dissection of the germinated seed to expose shoot apical meristem tissue.
Sairam et al. teach that shoot meristem tissues from young seedlings are highly suitable explants for plant transformation and regeneration because of their regenerative competence. See Abstract and page 495, left column. Sairam et al. further teach excision and use of shoot meristem explants from seedling tissues for transformation procedures. See page 496, Materials and Methods section.
Galán-Ávila et al. teach preparation of explants from early germinated seedlings at defined developmental stages. The reference teaches that “between 24 and 48 h” after culture, “seeds started to germinate and the apical root meristem arose from the testa.” See page 3, section “Seed Germination and Explant Preparation,” and Figure 1. Galán-Ávila et al. further teach dissection of young seedling tissues while identifying and preserving or removing vegetative shoot apex/shoot apical meristem regions. See Figure 1 and accompanying description at pages 3-4. Galán-Ávila et al. further asserts that such protocols “could have important connotations in exploitation of contemporary plant breeding techniques like genome editing (e.g., by using CRISPR/Cas gene edition)” See for example, lines 9-17 of “CONCLUSION” at right column of page 13.
Martin-Ortigosa et al. teaches (i) in planta application of editing reagents comprising gRNAs targeting endogenous plant genes, (ii) delivery into the shoot apical meristem, and (iii) either transformation with a construct expressing Cas9 or co-application of Cas9 and gRNAs. Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the earliest filing date, to first generate a stable transgenic plant expressing Cas9 and then apply gRNAs in planta to achieve desired genome editing. A skilled artisan would have been motivated to adopt this “bridge” Cas9 transgenic plant approach because it enables efficient editing of multiple endogenous genes with different gRNAs, thereby conserving time and resources, with a reasonable expectation of success. Further, use of any plant tissue, including seeds germinated into Cas9-expressing seedlings, would have been a matter of routine design choice. Routine assays of seed viability and Cas9 expression, such as dissecting germinated seeds while preserving the apical meristem, would also have been standard practice.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the CRISPR/Cas meristem-editing methods of Martin-Ortigosa et al. by utilizing early germinated seedling tissues containing exposed or proximate shoot apical meristem tissue, as taught by Sairam et al. and Galán-Ávila et al., because the art recognized such young meristematic tissues as highly regenerative, accessible for manipulation, and suitable for transformation procedures. One of ordinary skill in the art would have reasonably expected successful genome editing using known CRISPR/Cas editing reagents in such known meristematic explants.
Regarding claim 2, Martin-Ortigosa et al. teach applying genome editing reagents directly in vivo to exposed shoot apical meristem tissues and delivering the reagents into cells expressing Cas9 protein. See pages 6-8 and Example 10 at page 63.
Regarding claims 4 and 5, Galán-Ávila et al. teach dissecting young germinated seedling tissues to expose or isolate shoot apical meristematic regions. See Figure 1 and pages 3-4.
Regarding claim 6, Martin-Ortigosa et al. teach guide RNA delivery using particle bombardment, microinjection, and related in planta delivery systems. See pages 60-65 and Figures 5-7.
Regarding claim 10, Martin-Ortigosa et al. teach applying compositions containing genome editing reagents directly onto exposed meristematic tissues. See pages 61-64.
Regarding claim 12, Martin-Ortigosa et al. teach cold pretreatment of meristem tissues prior to delivery of editing reagents. See page 62.
Therefore, claims 1-6, 10 and 12 are unpatentable over Martin-Ortigosa et al. in view of Sairam et al. and Galán-Ávila et al.
9. Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Martin-Ortigosa et al. (WO 2016/184989 A1, published Nov. 24, 2016) in view of Sairam et al. (Genome, 46(2):323-329, 2003) and Galán-Ávila et al., (Frontiers in Plant Science 11:645, pages 1-15, 2020 doi: 10.3389/fpls.2020.00645), and further in view of Zhu et al. (Mol. Cell Biol. 21:661-677, 2020). This rejection has been necessitated due to claim amendments filed in the papers of May 21, 2026.
Martin-Ortigosa et al. teachings are discussed supra.
Sairam et al. teachings are discussed supra.
Galán-Ávila et al. teachings are discussed supra.
Martin-Ortigosa et al., Sairam et al., or Galán-Ávila et al. do not teach one of genome edits confers a selective advantage under a selective agent or condition.
Zhu et al. teach using CRISP-Cas/gRNA based approach in editing herbicide-targeted genes to confer endogenous resistance to a plant. The reference further teaches that introduction of a particular base mutation into endogenous plant ALS (Acetolactate synthase) gene with the use of CBEs (cytosine based editing) conferred herbicide (selective agent) resistance to plants while retaining ALS activity. Zhou et al. cites several examples (e.g. Huang et al. (Mol. Plant 13,565-572, 2020); Sun et al. (Mol. Plant 9, 628-631, 2016)) were herbicide resistance was achieved using similar approach. See in particular, 2nd paragraph at page 666, abstract at page 661; Figures 1-5; Table 1).
Given Zhu et al., teach using gene editing approach to produce herbicide-resistant (a selective agent) by targeting plant’s endogenous gene (ALS), it would have been obvious and within the scope of an ordinary skill in the art prior to earliest filing date of the claimed invention to have edited any endogenous plant gene to confer resistance to any selective agent, including herbicide resistance to the plant.
It would have been obvious to modify Martin-Ortigosa et al. method of genome editing in light of the combined teachings of Sairam et al., and Galán-Ávila et al., as discussed above to incorporate multiple gRNAs in editing solution, including the one that can target endogenous plant gene to confer resistance to a selective agent, such as herbicide resistance and thus arrive at the Applicant’s claimed invention with a reasonable expectation of success and without any surprising results. Obviously, one of skilled in the art would have been motivated to do so by incorporating multiple useful traits to a plant genetically engineered using a precise CRISPR/cas9 gRNA based approach as discussed above.
Thus, the claimed invention as a whole is prima facie obvious teachings of the prior art.
10. Claim(s) 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Martin-Ortigosa et al. (WIPO, WO 2016/184989 A1, Published November 24, 2016), in view of Sairam et al. (Genome, 46(2):323-329, 2003), Galán-Ávila et al., (Frontiers in Plant Science 11:645, pages 1-15, 2020 doi: 10.3389/fpls.2020.00645), and Zhu et al. (Mol. Cell Biol. 21:661-677, 2020), and further in view of Yin et al. (Sci Rep., 5:1038/srep14926, pp 1-10, 2015). This rejection has been necessitated due to claim amendments filed in the papers of May 21, 2026.
Martin-Ortigosa et al. teachings are discussed supra.
Sairam et al. teachings are discussed supra.
Galán-Ávila et al. teachings are discussed supra.
Zhu et al. teachings are discussed as supra.
Martin-Ortigosa et al., Sairam et al., Galán-Ávila et al. or Zhu et al. do not teach using viral vector based method of delivering genome editing reagent comprising gRNA.
Yin et al. explicitly recognize the difficulty of transforming certain plant species and identify the desirability of improved transformation techniques. Specifically, Yin et al. (page 7, last five lines of the Discussion section) state:
“As we know, many non-model plants and some model crop plants (such as maize, cotton) are difficult to transform, which hinders their reverse genetic study. With the advancement of sequencing and reduction in cost, more and more genomes of non-model plants will be uncovered quickly. Together, VIGE approach is a promising method to enable efficient genome engineering for many plants.”
It would have been obvious to one of ordinary skill in the art, prior to the earliest effective filing date of the claimed invention, to employ any efficient nucleic acid delivery method into intact plant material, including the viral vector based method taught by Yin et al., as a matter of design choice. One of ordinary skill in the art would have had a reasonable expectation of success in doing so, and the record does not demonstrate that the claimed invention yields any unexpected or surprising results.
This disclosure would have motivated a person of ordinary skill in the art to utilize efficient nucleic acid delivery methods, such as those recited in the present claims, to enable genome engineering in a variety of plants. The combination of Martin-Ortigosa et al., Sairam et al., Galán-Ávila et al. Zhu et al. and Yin et al. with routine skill in the art therefore renders the claimed subject matter obvious.
Furthermore, as explained in Ex parte Smith, slip op. at 20 (B.P.A.I. June 25, 2007), citing KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385, 1396 (2007), a finding of obviousness does not require an express teaching, suggestion, or motivation in the prior art. Rather, if a claimed invention represents no more than the predictable use of prior art elements according to their established functions, the invention is unpatentable as obvious. Here, the application of known nucleic acid delivery methods to intact plant materials represents such a predictable use.
Thus, the claimed invention as a whole is prima facie obvious teachings of the prior art.
11. Claim(s) 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Martin-Ortigosa et al. (WIPO, WO 2016/184989 A1, Published November 24, 2016), in view of Sairam et al. (Genome, 46(2):323-329, 2003), Galán-Ávila et al., (Frontiers in Plant Science 11:645, pages 1-15, 2020 doi: 10.3389/fpls.2020.00645), and Zhu et al. (Mol. Cell Biol. 21:661-677, 2020), and further in view of Alghuthaymi et al. (Int. J Mol Sci., 22(14),7456, pages 1-22, July 2021). This rejection has been necessitated due to claim amendments filed in the papers of May 21, 2026.
Martin-Ortigosa et al. teachings are discussed supra.
Sairam et al. teachings are discussed supra.
Galán-Ávila et al. teachings are discussed supra.
Zhu et al. teachings are discussed as supra.
Martin-Ortigosa et al., Sairam et al., Galán-Ávila et al. or Zhu et al. do not teach using carbon nanotube based method of delivering genome editing reagent comprising gRNA.
Alghuthaymi et al. teach a carbon nanotube based delivery system for CRISPR/Cas9 mediated plant genome editing. The reference clearly demonstrates a carbon nanotube based guide RNA (gRNA) delivery system for CRISPR/Cas9 mediated plant genome editing that can be used to precisely target genome locations and cause mutations. See in particular, abstract, Figures 1-3; Tables 1-2, items 1-10 at pages 1-22.
It would have been obvious to a person of ordinary skill in the art, prior to the earliest effective filing date of the claimed invention, to employ any efficient nucleic acid delivery method into intact plant material, including that taught by Alghuthaymi et al., as a matter of routine design choice. Such a person would have had a reasonable expectation of success in doing so, without encountering any unexpected or surprising results. Moreover, one of ordinary skill in the art would have been motivated to adopt this approach because organic carbon nanotubes possess advantageous properties—including size, charge, stability, and low toxicity relative to other delivery systems—as disclosed by Alghuthaymi et al.
The Federal Circuit and the Board have clarified that a specific teaching, suggestion, or motivation is not required to establish obviousness. See Ex parte Smith, – USPQ2d –, slip op. at 20 (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385, 1396 (2007)). Consistent with KSR, the claimed invention would have been no more than the predictable use of prior art elements according to their established functions.
Thus, the claimed invention as a whole is prima facie obvious teachings of the prior art.
12. While Applicants arguments to withdrawn rejections stand moot, however, for the sake of record, response to Applicant’s arguments are presented here due to the use of primary reference Martin-Ortigosa et al. and secondary references Zhu et al., Yin et al., or Alghuthaymi et al. in the new rejections under 103 necessitated due to claim amendments filed in the papers of May 21, 2026.
Applicant principally argues that the cited references fail to teach or suggest: (i) treating a seed to obtain a germinated seed at a stage in which the radicle has just emerged and the epicotyl has not or has just emerged; (ii) dissecting the germinated seed to expose a portion of shoot apical meristem proximate to an exposed surface; and (iii) carrying out genome editing in the resulting germinated seed section. However, the arguments are not persuasive for the reasons set forth below.
Martin-Ortigosa et al. teach in planta genome editing methods targeting shoot apical meristem tissue using CRISPR/Cas systems, including delivery of guide RNAs into meristematic tissue of plants expressing Cas9. The reference further teaches excision and manipulation of shoot apices and epicotyl-associated tissues for genome editing and transformation purposes.
Applicant argues that Martin-Ortigosa does not expressly disclose the precise germination stage recited in amended claim 1. The argument is acknowledged but not persuasive. The claimed germination stage represents optimization of known explant preparation variables, including developmental timing, tissue accessibility, and meristem viability. Selection of a germination stage in which: the radicle has emerged, and the epicotyl has not or has just emerged would have been an obvious matter of routine experimentation to one of ordinary skill in the art seeking accessible, viable meristem tissue for delivery of editing reagents. The prior art already teaches: meristem-targeted editing, manipulation of epicotyl/shoot apex tissue, in planta delivery to exposed meristems, and use of Cas9-expressing plants. Accordingly, adapting such techniques to germinated seed explants constitutes the predictable use of prior art elements according to their established functions.
Applicant’s Declaration has been considered but is not persuasive for the following reasons:
The declaration alleges unexpected results and superiority of the claimed method. However, the declaration does not adequately establish: a) that the alleged results are unexpected relative to the closest prior art; b) that the comparison is commensurate in scope with the claims; or c) that the alleged advantages arise specifically from the newly recited germination-stage limitations.
The claims encompass broad plant types, delivery methods, editing reagents, and editing targets. The declaration does not demonstrate unexpected performance across the full breadth of the claimed invention. Further, the evidence presented appears to show improvement in degree rather than a difference in kind. Optimization of explant developmental stage and meristem exposure would reasonably have been expected to affect transformation or editing efficiency.
The declaration further alleges long-felt need and failure of others. However, the evidence is insufficient to establish: (i) a recognized and persistent unmet need in the art specifically addressed by the claimed germinated seed-section method; or (ii) that others attempted and failed to achieve the claimed approach. The cited prior art itself demonstrates extensive ongoing development of meristem-based genome editing methods. Accordingly, the secondary considerations evidence is insufficient to outweigh the strong prima facie showing of obviousness.
Applicant argues that Zhu et al. does not remedy the deficiencies of Martin-Ortigosa et al. regarding the germinated seed limitations. The argument is not persuasive because Zhu et al. was not relied upon for those teachings. Rather, Zhu was cited for teaching CRISPR-mediated edits conferring selective advantage, including herbicide resistance through editing endogenous ALS loci.
Applicant argues that Yin et al. teach only leaf-based applications and does not teach seed editing. The argument is not persuasive because Yin et al. was relied upon solely for teaching viral vector-mediated delivery of genome editing reagents into plant tissue.
Applicant argues that Alghuthaymi et al. does not teach the claimed germinated seed preparation. The argument is acknowledged but not persuasive because Alghuthaymi et al. was relied upon only for teaching carbon nanotube-mediated delivery systems for CRISPR reagents.
Conclusions
13. Claims 1-14 remain rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vinod Kumar whose telephone number is (571) 272-4445. The examiner can normally be reached on 8.30 a.m. to 5.00 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. 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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/VINOD KUMAR/Primary Examiner, Art Unit 1663
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