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 .
The Applicants’ Amendment to the Claims filed on 09/03/2025 is entered.
Claims 1-57, 59-60, 66, 68, and 73-74 are canceled.
Claims 75-77 are new.
Claims 58, 61-62, 63, 64-65, 67, 69-72, and 75-77 are pending and under examination.
Information Disclosure Statement
The IDS filed on 09/03/2025 has been considered by the examiner.
Response to Amendment
Any/all objections and rejections made in a previous office action and not repeated in this office action are withdrawn.
Priority
This US 17/004,338 filed on 08/27/2020 which is a DIV of 14/685,568 filed on 04/13/2015 (now US Patent 10,851,380) which is a CON of PCT/KR2013/009488 filed on 10/23/2013 claims US priority benefit of US Provisionals 61/837,481 filed on 06/20/2013, 61/803,599 filed on 03/20/2013 and 61/717,324 filed on 10/23/2012.
The disclosure of the prior-filed applications 61/803,599 and 61/717,324 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, the ‘599 and ‘324 Provisionals fail to provide support for CRISPR methods using plant cells. Thus, present claims 58, 61-65, 67, and 69-72 receive priority to US Provisional 61/837,481 filed on 06/20/2013.
Claim Rejections - 35 USC § 103
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 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.
Further regarding 35 USC 103(a) rejections, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) (KSR) identified a number of rationales to support a conclusion of obviousness. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include the following list. This list of rationales is not intended to be an all-inclusive list.
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E} "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Currently amended claims 58, 61-62, 64-65, 67, 69-72, and 75-77 are rejected under 35 U.S.C. 103 as being unpatentable over US2015/0067922 to Yang et al (with US priority to US Provisional 61/828,737 filed on May 30, 2013; of record) in view of US Patent 10,731,181 to Chen et al (with priority to US Provisional 61/794,422 filed on 03/15/2013), in view of Gaj et al (Nature Methods (2012), 9: 805-807 and Supplemental Material). This is a new grounds of rejection. Yang et al citations refer to the ‘737. Chen et al citations refer to the ‘422.
Regarding base claim 58, Yang discloses a method of cleaving an endogenous target DNA in a plant cell. (See ‘737; ref claim 1). Yang teaches introducing into a rice plant protoplast a CRISPR/Cas9 complex comprising: a CRISPR Cas9 polypeptide and a guide RNA specific to the target genome DNA in the cell nucleus. (See ‘737; ref claims 1, 2; page 32, lines 11-17). Yang teaches that the guide RNA is a single-chain guide RNA comprising a CRISPR RNA (crRNA) fused to a trans- activating crRNA (tracrRNA). (See ‘737; ref claim 1, page 2, lines 20-28). Yang teaches that the target genome DNA is cleaved (reciting the term: for excision). (See ‘737; ref claim 1).
Regarding claim 61, Yang teaches that the CRISPR/Cas9 complex is introduced for plants by transfection. (See ‘737; pages 33-34). Yang teaches transfection by microinjection (See ‘737; page 33, line 22), electroporation (See ‘737; page 33, line 21), nanoparticle-mediated transfection (See ‘737; page 33, line 23), virus-mediated gene delivery (See ‘737; page 34, para 1), or polyethylene glycol (PEG)-mediated transfection of protoplasts. (See ‘737; page 34, lines 13-19; page 41, Section C.).
Regarding claims 62, Yang et al disclose using PEG-mediated transfection of rice cell protoplasts. Yang et al disclose using a 40% PEG4000 transfection buffer having 0.6 M Mannitol, 100 mM CaCl2. (See ‘737; page 41, lines 3-19).
Regarding claim 64, Yang teaches the Cas9 protein is from the genus Streptococcus. (See ‘737; page 2, lines 20-28).
Regarding claim 65, Yang teaches that the Cas9 protein is from Streptococcus pyogenes. (See ‘737; page 2, lines 20-28).
Regarding claim 67, Yang teaches that the Cas9 polypeptide comprises a nuclear localization signal (NLS). (See ‘‘737; page 64, line 17).
Regarding claim 69, Yang teaches that the crRNA is 20 nucleotides in length. (See ‘737; FIG 3B showing a twenty-nucleotide crRNA sequence for PS2-gRNA 5’-gaucccgccgccgaucccuc-3’-).
Regarding claim 70, Yang teaches that the target DNA is genomic DNA. (See ‘737; page 3, lines 9-10; page 32, lines 11-17).
Regarding claim 71 Yang teaches that the target DNA comprises a trinucleotide protospacer adjacent motif (PAM) recognized by Cas9, wherein the PAM consists of the trinucleotide 5'-NGG-3'. (See ‘737; FIG1; page 2, lines 20-28).
Regarding claim 72 Yang teaches that the plant cell is a protoplast (See ‘737; page 34, lines 13-19; page 41, Section C.).
Regarding claim 75 Yang teaches that the guide RNA is a single-chain guide RNA comprising a CRISPR RNA (crRNA) fused to a trans- activating crRNA (tracrRNA). (See ‘737; ref claim 1, page 2, lines 20-28).
Regarding claim 76 Yang teaches that the Cas9 protein comprises a nuclear localization signal (NLS), and wherein the NLS is disposed at a C-terminus of the Cas9 protein. (See ‘737, FIG 2). Also, Chen et al disclose Cas9 fused to an nuclear localization sequence called an NLS (para 0010 cites Cas9 protein; para 0023 cites NLS). Chen et al disclose this link can be at the N- or C-terminal (see para 0024).
Regarding claim 77, Yang et al disclose guide RNA may be in the form of a dual guide RNA or a single guide RNA. (See ‘737, pages 2-3). Chen discloses Chen teaches that the guide RNA and Cas9 would be provided in amounts that are about stoichiometric because it was known that functional Cas9/gRNA complexes were structured to have one Cas9 protein per one single guide RNA or one Cas9 protein per two dual guide RNAs. When using dual guide RNAs the guide RNA would be disposed in at least a two-fold molar excess over the Cas9 protein in the in vitro environment to achieve a functional Cas9/RNA complex.
However, Yang et al differs from the presently claimed invention because they do not explicitly disclose that the Cas9/gRNA complex is transferred to the plant cell in the form of a complex.
Chen et al suggest introducing Cas9/sgRNA complex into eukaryotic cells by means of transfection. Chen et al disclose that the RNA-guided endonuclease is Cas9 and the RNA-guided endonuclease is “introduced into the cell as a RNA-protein complex comprising the endonuclease protein and the guiding RNA”. (See para 0080-0081). Chen et al suggest introducing the Cas9 protein and a guide RNA into a eukaryotic cell or embryo. (para 0041). For example, in para 0047, lines 11-13, Chen et al state: “In still other embodiments, the fusion protein can be introduced into the cell or embryo as an RNA-protein complex comprising the fusion protein and the guiding RNA”. Chen et al disclose Cas9 fused to an nuclear localization sequence called an NLS (para 0010 cites Cas9 protein; para 0023 cites NLS). Chen et al disclose this link can be at the N- or C-terminal (see para 0024). The purpose of the NLS is to introduce the Cas9 complex into the nucleus of the eukaryotic cell. Chen et al disclose that methods of introducing into eukaryotic cells include transfection, nucleofection, and electroporation and state that “Transfection methods are well known in the art” (see para 0066). Further, introducing may be by microinjection (para 0066, last sentence). In para 0075-0076 lists suitable type of eukaryotic cells including plant cells. Also, reference claims 28 & 37 recite a plant cell.
The level of skill in the art was high before the effective filing date of the presently claimed invention.
One or ordinary skill in the art would have been motivated to transfect the Cas9/sgRNA complex into the plant cell as a complex because Chen et al expressly suggest transfecting a Cas9/sgRNA complex into eukaryotic cells, including plant cells. It would have been obvious to do such because Yang et al and Chen et al are in the same field of Cas9/sgRNA gene editing in eukaryotic cells.
In view of the high skill in the art before the effective filing date of the presently claimed invention it is considered that one of ordinary skill in the art having the cited references before the effective filing date of the presently claimed invention would have had a reasonable expectation of success to combine the preferred embodiments of Yang et al as described in the body of the rejection above with the suggestion of Chen et al to introduce the Cas9/gRNA complex into the cells as a complex using means such as transfection/microinjection methods of Chen et al and Yang et al to arrive at the claimed composition.
Gaj teaches direct delivery of genome-editing zinc-finger nuclease (ZFN) proteins for endogenous gene disruption (Abstract). Gaj teaches the ZFN comprised an NLS (Fig 1a). Gaj teaches purifying ZFNs and diluted into serum-free medium (i.e., cell-free buffer and a transfection mixture) (Methods, page 1, last ]). Gaj teaches treating eukaryotic cells with the medium/ZFN mixture (i.e., transfecting the cells) (Methods, page 2, 4/2). Gaj teaches the ZFN modified the host cell genome (Fig 1fc-f). Gaj teaches an advantage of delivering ZFN to cells as a protein instead of plasmid is reduced ZFN-induced modifications at off-target sites (page 807, 42). Gaj teaches this is likely due to the short half-lives of the transduced ZFN and limiting the duration of ZFN in cells (page 807, 4/2).
Gaj also teaches that directly delivering the gene editing proteins, instead of expressing them from plasmids, avoids the risk of insertional mutagenesis (page 807, 75). Gaj teaches “that protein delivery and the benefits afforded therein will be extended to other designer nucleases” (page 807, 45).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to have formed the Cas9/sgRNA complex taught in Yang and delivered it directly to eukaryotic cells as taught in Chen. It would have amounted to using known Cas9/gRNA complexes in known ways to yield predictable results. The skilled artisan would have predicted that the Cas9/sgRNA complex could be introduced into cells because both Chen and Yang suggest it and Gaj demonstrates the protein delivery of a different designer nuclease. The skilled artisan would have been motivated to do so because Gaj teaches that direct delivery of a designer nuclease avoids the risks of plasmid-based delivery including off-target cleavage and insertional mutagenesis. Further, the skilled artisan would have specifically motivated to deliver the Cas9/sgRNA complex that had formed in the buffer because Yang teaches the ribonucleoprotein is the active form for Cas9.
Response to Arguments
The Applicants’ arguments filed on 09/03/2025 have been fully considered but are unpersuasive. The applicant argues that “Yang and Chen, whether considered separately or in combination, fail to teach or suggest each and every recited feature of the pending claims”. Further the applicant argue that “unexpected results confirm the nonobviousness of the pending claims”.
The applicant’s argument that Chen’s techniques involve fusion proteins and complexes thereof is unpersuasive because the present claims are drawn to a fusion protein which is the Cas9 protein fused to an NLS. Further, the applicants argument that a reference was made in the body of the rejection to a paragraph of the Chen patent is unpersuasive because the elements relied on for the rejection are also provided for in the US Provisional 61/794,422 filed on 03/15/2013. For example, para 121 of the Chen Patent
Further the applicant argument that “unexpected results confirm the nonobviousness of the pending claims” is unpersuasive. Results shown in the instant Specification show that results using plasmid DNA expressing the Cas9 protein were better than results achieved using Cas9/sgRNA complex. (See FIG10 of the 61/837,481 Provisional filed on 06/20/2013). This evidence in the instant Specification weighs in direct contrast against the applicant’s argument of unexpected results. Further, the applicant’s argument regarding unexpected reduction of off-target effects while maintaining or improving on-target efficiencies is unpersuasive because the results achieved were not commensurate with the presently claimed invention. The applicants argument that “unexpected results are commensurate in scope with the recited subject matter because they were observed in different type of plants cells when cleaving different target sites” is unpersuasive because the conditions of the cited post-filing references are not commensurate with the conditions of the present claims.
Double Patenting
Response to Arguments regarding NSDP rejection
The Applicants’ arguments filed on 09/03/2025 have been fully considered but are unpersuasive. The applicants argue that the pending claims of US Patent 12,241,071 in view of Chen are patentably distinct. Specifically the applicants argue that the reference claims do not recite the feature that the Cas9/RNA complex is complexed in an environment prior to being introduced into the plant cell. Further, the applicants argue that Chen does not teach the feature that the Cas9/RNA complex is complexed in an environment prior to being introduced into the plant cell. However, this argument is unpersuasive for reasons provided in the body of the rejection and herein. The NSDP rejection is for obviousness rather than anticipation. The US Patent 12,241,071 recites the limitations of a method of making a genome-edited petunia plant by introducing an S pyogenes Cas9 protein and a gRNA into a plant protoplast cell. Copending claim 1 recites a 20 base target sequence. Copending claim 1 recites that the Cas9-gRNA composition induces an indel by cleaving a genomic sequence. Regarding claim 61, patented claim 2 recites that the CRISPR/Cas9 composition is introduced by lipid-mediated transfection, electroporation, nanoparticle- mediated transfection or polyethylene glycol (PEG)-mediated transfection of the protoplast cell. Regarding claim 71 patented claim 1 recites S pyogenes and targeting genomic DNA. The protospacer adjacent motif (PAM) recognized by S pyogenes Cas9, is inherently 5'-NGG-3'. Chen et al suggest introducing Cas9/sgRNA complex into eukaryotic cells by means of transfection. Chen et al disclose that the RNA-guided endonuclease is Cas9 and the RNA-guided endonuclease is “introduced into the cell as a RNA-protein complex comprising the endonuclease protein and the guiding RNA”. (See para 0080-0081). Chen et al suggest introducing the Cas9 protein and a guide RNA into a eukaryotic cell or embryo. (para 0041). For example, in para 0047, lines 11-13, Chen et al state: “In still other embodiments, the fusion protein can be introduced into the cell or embryo as an RNA-protein complex comprising the fusion protein and the guiding RNA”. Regarding claim 67, Chen et al disclose Cas9 fused to an nuclear localization sequence called an NLS (para 0010 cites Cas9 protein; para 0023 cites NLS). Chen et al disclose this link can be at the N- or C-terminal (see para 0024). The purpose of the NLS is to introduce the Cas9 complex into the nucleus of the eukaryotic cell. Chen et al disclose that methods of introducing into eukaryotic cells include transfection, nucleofection, and electroporation and state that “Transfection methods are well known in the art” (see para 0066). Further, introducing may be by microinjection (para 0066, last sentence). In para 0075-0076 lists suitable type of eukaryotic cells including plant cells. In para 6, last sentence, Chen et al recite that in certain embodiments, the eukaryotic cell can be a plant cell. In para 8, Chen et al recite that in certain embodiments, the eukaryotic cell can be a plant cell. In para 117, Chen et al recite: “A variety of eukaryotic cells and embryos are suitable for use in the method. For example, the cell can be a human cell, a non-human mammalian cell, a non-mammalian vertebrate cell, an invertebrate cell, an insect cell, a plant cell, a yeast cell, or a single cell eukaryotic organism”.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Currently amended claims 58, 61, 64-65, 67, and 69-72 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of US Patent 12,241,071 (formerly US Application No. 16/973,140), in view of US Patent 10,731,181 to Chen et al (with priority to US Provisional 61/794,422 filed on 03/15/2013). Chen et al citations refer to the ‘422.
Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of patented claims and Chen et al renders obvious the instant claims.
Regarding instant claims 58, 64-65, 69-70, and 72, patented claim 1 recites a method of making a genome-edited petunia plant by introducing an S pyogenes Cas9 protein and a gRNA into a plant protoplast cell. Copending claim 1 recites a 20 base target sequence. Copending claim 1 recites that the Cas9-gRNA composition induces an indel by cleaving a genomic sequence.
Regarding claim 61, patented claim 2 recites that the CRISPR/Cas9 composition is introduced by lipid-mediated transfection, electroporation, nanoparticle- mediated transfection or polyethylene glycol (PEG)-mediated transfection of the protoplast cell.
Regarding claim 71 patented claim 1 recites S pyogenes and targeting genomic DNA. The protospacer adjacent motif (PAM) recognized by S pyogenes Cas9, is inherently 5'-NGG-3'.
However, the patented claims do not recite that the Cas9-gRNA is formed as a complex before introducing into the plant protoplast. Also, regarding claim 67, patented claims do not recite attaching an NLS to the Cas9 to achieve nuclear import to cleave a genomic DNA target.
Chen et al suggest introducing Cas9/sgRNA complex into eukaryotic cells by means of transfection. Chen et al disclose that the RNA-guided endonuclease is Cas9 and the RNA-guided endonuclease is “introduced into the cell as a RNA-protein complex comprising the endonuclease protein and the guiding RNA”. (See para 0080-0081). Chen et al suggest introducing the Cas9 protein and a guide RNA into a eukaryotic cell or embryo. (para 0041). For example, in para 0047, lines 11-13, Chen et al state: “In still other embodiments, the fusion protein can be introduced into the cell or embryo as an RNA-protein complex comprising the fusion protein and the guiding RNA”. Regarding claim 67, Chen et al disclose Cas9 fused to an nuclear localization sequence called an NLS (para 0010 cites Cas9 protein; para 0023 cites NLS). Chen et al disclose this link can be at the N- or C-terminal (see para 0024). The purpose of the NLS is to introduce the Cas9 complex into the nucleus of the eukaryotic cell. Chen et al disclose that methods of introducing into eukaryotic cells include transfection, nucleofection, and electroporation and state that “Transfection methods are well known in the art” (see para 0066). Further, introducing may be by microinjection (para 0066, last sentence). In para 0075-0076 lists suitable type of eukaryotic cells including plant cells. In para 6, last sentence, Chen et al recite that in certain embodiments, the eukaryotic cell can be a plant cell. In para 8, Chen et al recite that in certain embodiments, the eukaryotic cell can be a plant cell. In para 117, Chen et al recite: “A variety of eukaryotic cells and embryos are suitable for use in the method. For example, the cell can be a human cell, a non-human mammalian cell, a non-mammalian vertebrate cell, an invertebrate cell, an insect cell, a plant cell, a yeast cell, or a single cell eukaryotic organism”. Also, reference claim 6 recites a plant cell. In para 121, Chen et al recite:
(121) Fusion proteins comprising a CRISPR/Cas-like protein or a fragment thereof and an effector domain are detailed above in section (II). In general, the fusion proteins disclosed herein further comprise at least one nuclear localization signal. Nucleic acids encoding fusion proteins are described above in section (III). In some embodiments, the fusion protein can be introduced into the cell or embryo as an isolated protein (which can further comprise a cell-penetrating domain). Furthermore, the isolated fusion protein can be part of a protein-RNA complex comprising the guide RNA.
Chen et al recite in para 105: “Transfection methods are well known in the art (see, e.g., “Current Protocols in Molecular Biology” Ausubel et al., John Wiley & Sons, New York, 2003 or “Molecular Cloning: A Laboratory Manual” Sambrook & Russell, Cold Spring Harbor Press, Cold Spring Harbor, N.Y., 3.sup.rd edition, 2001). “
One or ordinary skill in the art would have been motivated to combine the elements of the patented claims with the method suggest by Chen et al to transfect the Cas9/sgRNA complex into the plant cell as a complex because Chen et al expressly suggest transfecting a Cas9/sgRNA complex into eukaryotic cells and attaching an NLS to the Cas9 to achieve transport to the cell nucleus to edit genomic DNA, including plant cells. It would have been obvious to do such because patented claims and Chen et al are in the same field of Cas9/sgRNA gene editing in eukaryotic cells.
Currently amended claims 58, 61, 67, 70, and 75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending claim 5 of US Application 19,023,934. This is new grounds necessitated by amendment.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claim renders obvious the instant claims.
Regarding instant claims 58, 61, 64-65, 67, and 75, copending claim 5 recites a method of transfecting a Cas9-NLS/sgRNA complex into a plant cell by forming the complex in a cell-free buffer before introducing the complex to the cell for editing a genomic DNA target in the nucleus of the cell. Thus the copending claim recites the elements of the presently amended claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 63 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Yang et al disclose using PEG-mediated transfection of rice cell protoplasts. Yang et al disclose using a 40% PEG4000 transfection buffer having 0.6 M Mannitol, 100 mM CaCl2. (See ‘737; page 41, lines 3-19). However, regarding claim 63, Yang does not teach or fairly suggest a 40% PEG4000 transfection buffer having 0.2 M Mannitol, 100 mM CaCl2.
Conclusion
No claim is allowed.
The following related art is considered pertinent to applicant's disclosure and may be applied in a future office action if appropriate.
Gasiunas et al in Cas9-crRNA ribonucleoprotein complex mediates specific DNA cleavage for adaptive immunity in bacteria. (Proceedings of the National Academy of Sciences of the United States of America 109, E2579 Sep. 25, 2012).
The Ayre Dissertation “Ribozyme-Mediated Gene Regulation: Potential for Controlling Gene Expression in Higher Plants” University of Alberta, Canada, 1995; of record).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE S HIBBERT whose telephone number is (571)270-3053. The examiner can normally be reached M-F 8:00-5:00.
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CATHERINE S. HIBBERT
Primary Examiner
Art Unit 1658
/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658