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 .
Application Status
This action is written in response to applicant’s correspondence received 06/21/2023. Claims 1-21 are currently pending and are examined herein.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1-3, 8-11 and 16-17 are objected to for the following informalities: the claim recites the word “gemone”. This appears to be a typographical error of the word “genome”. Appropriate correction is required.
Objections to the Specification
The disclosure is objected to because of the following informalities: the word “genome” is mis-spelled as “gemone” in multiple locations (see e.g. paras [0011]-[0013]). Appropriate correction is required.
Examiner’s Note:
Applicant is advised that should claims 1-8 be found allowable, claims 9-16 will be objected to under 37 CFR 1.75 as being a substantial duplicates thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). While the claims differ insofar as claim 1 recites a step of selecting a transformant and claim 9 does not, both claims recite wherein the counter selection marker induces the death of a host cell comprising the helper plasmid with the linear fragment (i.e., non-transformed cells). The function of inducing the death of non-transformed cells, as recited in both claims, is a selection step in and of itself, even if the step is not actively recited, because the elimination of only non-transformed cells and retention of transformed cells effectively amounts to a de facto step of selecting transformants.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
For example, the phrasing, “in a state of introducing the linear nucleic acid fragment into the helper plasmid for transformation, a pair of homologous recombination sequences that undergoes homologous recombination between a region outside of the gene of interest and a given site of the genome and a pair of endonuclease target sequences at the outside of the pair of homologous recombination sequences are provided” is unclear because it appears to mean that the recombination and endonuclease target sequences are provided while the linear nucleic acid fragment is incorporated into the helper plasmid, but the specification (see e.g., Figs. 1-8) makes clear that the inventors envisioned a helper plasmid with the homologous sequences and endonuclease target sites present prior to incorporation. As a result, it is unclear exactly what is meant by provided, and where the various elements are located: on the linear fragments, on the helper plasmid, separate from both, etc.
Additionally:
Claim 8 recites “the plurality of the linear nucleic acid fragments”. There is insufficient antecedent basis for this term.
In the interest of customer service and compact prosecution, the claims will be interpreted as described below in Claim Interpretation and examined under that interpretation.
Those claims identified in the statement of rejection but not explicitly referenced in the rejection are also rejected for depending from a rejected claim but failing to remedy the indefiniteness therein.
Claim Interpretation
Claim 1 is interpreted as follows:
The claim is drawn to a method of producing a transformant. The method comprises a step of introducing to a host cell: one or more linear nucleic acid fragments for insertion into a genome, and a helper plasmid, wherein the helper plasmid comprises: i) a pair of homologous recombination sequences designed to incorporate the linear nucleic acid fragments into a given site in a genome, and,
ii) a counter selection marker;
wherein, as the linear nucleic acid fragment is incorporated into the helper plasmid, a pair of endonuclease target sequences outside the pair of homologous recombination sequences are introduced to the cell; and,
the method further comprises a step of selecting a transformant in which the gene of interest is incorporated into the given site of the host genome, and in which the gene of interest is expressed,
wherein the counter selection marker functions to induce the death of a host comprising the helper plasmid comprising the one or more linear nucleic acid fragments.
Claim 2 is interpreted as specifying that the helper plasmid comprises the pair of homologous recombination sequences and the pair of endonuclease target sites somewhere on the plasmid, i.e., that these elements are not provided on a separate nucleic acid fragment or plasmid.
Claim 3 is interpreted as limiting the linear nucleic acid fragments so that they comprise a first pair of homologous recombination sequences (HR1) for genome integration flanking the gene of interest, endonuclease target sites (ETS) flanking the first pair of homologous recombination sequences , and a second pair of homologous recombination sequences (HR2) for integration of the gene of interest into the helper plasmid (i.e., the structure might be represented by 5’-HR2-ETS-HR1-GOI-HR1-ETS-HR2-3’).
Claims 4-7 recite wherein the helper plasmid further comprises a coding sequence for an endonuclease that specifically cleaves the endonuclease target sites, and that the endonuclease is a homing endonuclease operatively linked to an inducible promoter.
Claim 8 recites the method wherein the linear nucleic acid fragments consist of 1st to nth nucleic acid fragments, and the 3’ terminal sequence of the mth linear nucleic acid fragment (m being greater than or equal to 1 and less than or equal to n-1) comprises a sequence that undergoes homologous recombination with a 5’ terminal sequence of the mth + 1 linear nucleic acid fragment (i.e., anywhere from the 1st fragment to the nth).
Claims 9-16 are substantial duplicates of claims 1-8, and claims 17-21, while drawn to the helper plasmid, recite substantially the same structures present in the helper plasmid as recited in the claims drawn to methods of transformation.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 and 14 are rejected 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. Claims 6 and 14 recite wherein the endonuclease target sequence is specifically recognized by [the] homing endonuclease. However, claims 4 and 12, from which claims 6 and 14 respectively depend via claims 5 and 13, recite that the endonuclease is target-specific and specifically cleaves the target sequence. Claims 5 and 13 both limit the endonuclease to a homing endonuclease as recited in the instantly rejected claims. If the homing endonuclease is target specific and specifically cleaves the target sequence, then the homing endonuclease target sequence must be, by definition, specifically recognized by the target-specific endonuclease. Therefore, the instantly rejected claims fail to further limit the subject matter of the claim(s) upon which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4-7, 9-10, 12-15, and 17-21 are rejected under 35 U.S.C. 103 as being anticipated by U.S. PGPUB 20200399659 A1 to Onishi (hereinafter ‘Onishi’, published 12/24/2020, effectively filed date 06/24/2019), in view of U.S. PGPUB 2017/0121691 A1 to Wacker (hereinafter ‘Wacker’).
NOTE: the instant application claims priority to a foreign application JAPAN-20200213177 filed on 12/23/20, however:
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
The applied reference has a common assignee/inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1, Onishi teaches a method of producing a transformant, the method comprising a step of introducing to a host cell: one or more linear nucleic acid fragments for insertion into a genome, and a helper plasmid, wherein the helper plasmid comprises: i) a pair of homologous recombination sequences designed to incorporate the linear nucleic acid fragments into a given site in a genome;
wherein, as the linear nucleic acid fragment is incorporated into the helper plasmid, a pair of endonuclease target sequences outside the pair of homologous recombination sequences are introduced to the cell; and,
the method further comprises a step of selecting a transformant in which the gene of interest is incorporated into the given site of the host genome, and in which the gene of interest is expressed (see Claim Interpretation above for this language):
Abstract: A method for producing a transformant, comprising a step of introducing into a host, linear genome-introduced nucleic acid fragment(s) comprising a gene of interest and a helper plasmid for transformation having a pair of homologous recombination sequences for incorporation of the linear genome-introduced nucleic acid fragment(s), and then selecting a transformant, in which the gene of interest is incorporated into the predetermined position in the host genome and the gene of interest is expressed therein.
[0015] introducing into a host, one or a plurality of linear genome-introduced nucleic acid fragments each comprising a gene of interest to be introduced into a predetermined position on a genome, and a helper plasmid for transformation comprising a pair of homologous recombination sequences for incorporation of the linear genome-introduced nucleic acid fragments, wherein, in a state in which the linear genome-introduced nucleic acid fragments are incorporated into the helper plasmid for transformation, a pair of homologous recombination sequences for homologous recombination that takes place outside of the gene of interest and at the predetermined position on the genome, and a pair of endonuclease target sequences outside of the pair of homologous recombination sequences are disposed; and
[0016] selecting a transformant, in which the gene of interest is incorporated into the predetermined position on the host genome and the gene of interest is expressed therein.
Please note that the broadest reasonable interpretation of the claim encompasses introducing the homologous sequences and endonuclease sites as part of the helper plasmid.
Onishi does not teach that the helper plasmid comprises a counter selection marker.
Wacker teaches a plasmid for recombination, the plasmid comprising the same elements (the homologous sequences sandwiching the gene of interest and flanked by endonuclease target sites, plus a selection marker), wherein the marker is a counter selection marker:
[0006] In one aspect, provided herein are methods for inserting contiguous sequences of DNA, including large, contiguous sequences of DNA, into host cell genomes.
[0015] …wherein the donor plasmid comprises: (i) from 5′ to 3′: (1) the recognition sequence of the restriction endonuclease; (2) a first homology region of at least 0.5 kilobases (kb), (3) a heterologous insert DNA of at least 8 kb; and (4) a second homology region of at least 0.5 kb; and (ii) a counterselection marker.
Wacker teaches that the counter selection marker is used to repress growth of host cells that comprise the non-integrated plasmid (para [0091]).
Onish and Wacker differ in that Onishi teaches the introduction of linear nucleic acid fragments, while Wacker does not, and Wacker teaches fundamentally the same plasmid, including with a counter selection marker, but does not teach the introduction of linear nucleic acid fragments.
It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have combined the plasmid for recombination as taught by Onishi with the counter selection marker as taught by Wacker, to achieve the predictable result of a plasmid for recombination which can be used to eliminate cells which have not successfully undergone recombination, as an additional verification and quality control mechanism. The ordinary artisan would have had a reasonable expectation of success based on Wacker’s teachings that a counter selection marker could be added to a plasmid with the same elements as Onishi’s and function effectively to select transformed cells.
Regarding claim 2, Onishi in view of Walker render obvious the method comprising introducing the helper plasmid as already described above.
Regarding claims 4-7, Onishi teaches that the helper plasmid further comprises a coding sequence for an endonuclease that specifically cleaves the endonuclease target sites, and that the endonuclease is a homing endonuclease operatively linked to an inducible promoter.
[0017] (12) The transformation method according to the above (9), wherein the helper plasmid for transformation comprises a target-specific endonuclease gene that specifically cleaves the double strands of the endonuclease target sequences in an expressible state….(19) The helper plasmid for transformation according to the above (18), wherein the target-specific endonuclease gene is a homing endonuclease gene…(21) The helper plasmid for transformation according to the above (18), comprising an inducible promoter regulating the expression of the target-specific endonuclease gene.
Regarding claims 9-10, 12-15, and 17-21: as already discussed, these claims are either substantial duplicates of claims 1-8 (here 1-2 and 4-8) or recite a product already recited in the method claims. Therefore, insofar as Onishi in view of Walker renders obvious the limitations of claims 1-2 and 4-7, they also render obvious the same limitations in the remaining claims.
Claims 3, 8, 11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Onishi in view of Wacker, as applied to claims 1-2, 4-7, 9-10, 12-15, and 17-21 above, further in view of Mizutani (Mizutani. High-throughput plasmid construction using homologous recombination in yeast: its mechanisms and application to protein production for X-ray crystallography. Bioscience, Biotechnology, and Biochemistry, 2015, 79(1), 1–10.)
Onishi and Wacker render obvious the method of claims 1 and 9, as discussed above.
Regarding claims 3 and 11, Onishi and Wacker do not teach wherein the linear nucleic acid fragment comprises a pair of homologous recombination sequences for incorporation into a given site of a genome (i.e., a first pair of homologous recombination sequences), a pair of endonuclease target sequences outside of the first pair of homologous recombination sequences, and a second pair of homologous recombination sequences that undergo homologous recombination with the helper plasmid and are outside of the endonuclease target sites. These limitations amount to a method/plasmid in which the linear nucleic acid fragments comprising the cassette taught by Onishi and Wacker (i.e., a cassette comprising a gene of interest flanked by the homologous recombination sequences required for genome integration and the endonuclease target sites for excision from the plasmid) are delivered to a cell along with the helper plasmid, and the linear nucleic acid fragments recombine with the helper plasmid to insert the gene of interest into the helper plasmid, together with its flanking homologous sequences and endonuclease sites (both required for genome integration), after which the expression of the endonuclease is induced and the gene of interest with the genome-targeting homologous sequences is excised for incorporation into a genome via homologous recombination.
Regarding claims 8 and 16, Onishi and Wacker also do not teach multiple linear nucleic acid fragments wherein the 3’ end of the mth fragment comprises a sequence that undergoes homologous recombination with a 5’ end of the mth + 1 fragment. In other words, the method comprises connecting multiple linear nucleic acid fragments through homologous recombination, presumably prior to insertion in the helper plasmid via the homologous recombination sequences present in the plasmid with the sequences at the 5’ end of the 1st fragment and 3’ end of the nth fragment.
Mizutani teaches high-throughput plasmid construction in yeast (Title). Mizutani notes that, “Homologous recombination in S. cerevisiae can connect multiple fragments” (p. 1 right), and that, “plasmid construction can be done by homologous recombination in S. cerevisiae itself” (p. 4). The method encompasses, “Transformation of S. cerevisiae using three DNA fragments, an E. coli plasmid (cut at multiple cloning sites), a target gene (with homologous sequence of the multiple cloning site at both ends), and a helper plasmid (cut by two restriction enzymes),” and “enables construction of an expression plasmid by homologous recombination in yeast cells” (p. 5). Fig. 3B shows this approach, in which nucleic acid fragments are joined to each other and inserted into the plasmid via homologous recombination, using two sets of homologous recombination sequences. Lastly, Mizutani notes that this method, “This method has various advantages over the traditional method, including flexibility in the position of DNA insertion and ease of manipulation.” (Abstract).
It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have combined the method for transformation, comprising the introduction of linear nucleic acid fragments (i.e., cassettes comprising the gene of interest and the elements required to excise it from the plasmid and insert it into the genome) and the helper plasmid comprising the recited marker, endonuclease sites, and homologous recombination sequences, as taught by Onishi and Wacker, with the method of transforming yeast efficiently with multiple linear nucleic acid fragments to construct a gene insert in the cell prior to incorporation into the plasmid and expression in the cell. The skilled artisan would have been motivated to use Mizutani’s plasmid construction approach to inset the linear cassettes into the plasmid based on Mizutani’s statement that the method had various advantages over the traditional method, including flexibility in the position of DNA insertion and ease of manipulation. The skilled artisan would also have had a reasonable expectation of success, as Onishi and Wacker teach a functional helper plasmid capable of expression in a host cell and of facilitating recombination of a gene of interest into a genome, and Mizutani merely provides a known effective way to combine and insert a gene of interest into a plasmid in the host cell.
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Wacker (cited above) in view of Mizutani (cited above).
Wacker teaches a method for transformation which comprises introducing into a host cell a helper plasmid with a counter selection marker, a gene of interest flanked by homologous recombination sequences which are further flanked by endonuclease target sites, and a homing endonuclease gene operably linked to an inducible promoter, as already discussed above. Wacker also teaches that the plasmid has a counter selection marker for inducing death in host cells comprising the helper plasmid (i.e., which have not excised the cassette comprising the gene of interest and incorporated it into the genome), also as discussed above.
Wacker does not teach the introduction of multiple linear nucleic acid fragments, as recited in claim 1, or the limitations of claims 3, 8, 11, and 16, which pertain to the structure of the linear nucleic acid fragments, as already discussed above.
Mizutani teaches the high-throughput method of constructing plasmids for expression in yeast, comprising the use of homologous recombination to combine multiple DNA fragments to generate an insert, and then to incorporate the insert into the plasmid, as already discussed above.
It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have combined the method for transformation comprising the helper plasmid with counter selection, as taught by Wacker, with the method of plasmid construction as taught by Mizutani. As discussed above, the skilled artisan would have been motivated to do so based on Mizutani’s teaching that the method had various advantages over the traditional method, including flexibility in the position of DNA insertion and ease of manipulation, and would further have had a reasonable expectation of success, based on the fact that both methods were known effective.
Double Patenting
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,338,454 B2 in view of Wacker (cited above) and Mizutani (cited above).
Regarding claims 1-2, 9-10 and 17-21, patented claims 1 and 5 recite methods of producing a transformed yeast host comprising introducing one or more linear nucleic acid fragments and a helper plasmid comprising a pair of homologous recombination sequences for incorporation of a gene of interest into a genome, wherein the homologous recombination are sequences flanked by a pair of endonuclease target sequences. While the patented claims do not recite that the plasmid has a counter selection marker that is used to induce death in cells comprising the plasmid, that limitation is rendered obvious by Wacker, as discussed above.
Regarding claims 4-7, 12-15 and 18-21, patented claims 1-3 and 5-7 recite that the plasmid comprises a gene encoding a homing endonuclease that specifically cleaves double strands of the endonuclease target sequences.
Regarding claims 8 and 16, patented claims 4 and 8 recite the linear nucleic acid fragments with the same homologous recombination sequences at their 5’ and 3’ termini, which permit homologous recombination between the fragments.
Regarding claims 3 and 11, while the patented claims recite only that the linear nucleic acids comprise a gene of interest but do not recite the particular structure of the linear nucleic acid molecules, i.e., that the fragments themselves comprise, in addition to the gene of interest, the endonuclease target sites and the homologous recombination sequences for incorporation of the gene of interest into the genome, these elements are rendered obvious by Mizutani for the same reasons already discussed in the rejections of the claims under 35 U.S.C. 103 over Wacker and Mizutani.
Claims 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/258,909 in view of Mizutani (cited above)
This is a provisional nonstatutory double patenting rejection.
Regarding claims 1-2, 4-7, 9-10, 12-15 and 17-21, copending claims 7-10 recite methods of producing a transformant comprising introducing the plasmid of copending claim 6. This plasmid comprises the same homologous sequences, endonuclease sites, counter selection marker, and homing endonuclease gene with an inducible promoter as recited in the instant claims.
The copending and instant claims differ in that the copending claims do not recite a plurality of linear nucleic acid molecules comprising the endonuclease sites and homologous sequences as recited in instant claims 1, 3, 8, 11 and 16. However, those elements are rendered obvious by Mizutani, as already discussed above. Mizutani teaches methods of constructing plasmids in yeast, which comprise introducing multiple linear DNA fragments, linking them through homologous recombination at the 5’ and 3’ termini, then inserting the resulting cassette into the plasmid through homologous recombination with matching sequences in the plasmid. It would have been obvious to modify the copending plasmids and methods to include steps of plasmid construction as taught by Mizutani, because Mizutani teaches that this method of plasmid construction offers multiple advantages compared to the traditional ones.
Claims 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application Nos. 18/258,909 and 18/255,151 in view of Mizutani (cited above)
This is a provisional nonstatutory double patenting rejection.
Regarding claims 1-2, 4-7, 9-10, 12-15 and 17-21, both sets of copending claims 7-10 recite methods of producing a transformant comprising introducing the plasmid of copending claim 6. This plasmid comprises the same homologous sequences, endonuclease sites, counter selection marker, and homing endonuclease gene with an inducible promoter as recited in the instant claims.
Both sets of copending differ from the instant claims in that the copending claims do not recite a plurality of linear nucleic acid molecules comprising the endonuclease sites and homologous sequences as recited in instant claims 1, 3, 8, 11 and 16. However, those elements are rendered obvious by Mizutani, as already discussed above. Mizutani teaches methods of constructing plasmids in yeast, which comprise introducing multiple linear DNA fragments, linking them through homologous recombination at the 5’ and 3’ termini, then inserting the resulting cassette into the plasmid through homologous recombination with matching sequences in the plasmid. It would have been obvious to modify the copending plasmids and methods to include steps of plasmid construction as taught by Mizutani, because Mizutani teaches that this method of plasmid construction offers multiple advantages compared to the traditional ones.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA M ZAHORIK whose telephone number is (703)756-1433. The examiner can normally be reached M-F 8:00-16:00 EST.
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/A.M.Z./Examiner, Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636