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 .
Priority
Acknowledgment is made of applicant’s claim for priority based on a foreign application filed as JP 2021/148639 on 09/13/2021.
Should applicant desire to obtain the benefit of foreign priority of the foreign application
filed as JP 2021/148639 on 09/13/2021 under 35 U.S.C. 119(a)-(d) prior to declaration of
an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the
non-English application.
All claims are given the priority date of 02/21/2024.
Application Status
Receipt is acknowledged of amendment, filed 02/21/2024. Claims 1-14 are currently pending.
Information Disclosure Statement
Receipt of acknowledgment of the information disclosure statements filed on 02/21/2024 and 02/28/2024 have been received and all references have been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, specifically at paragraph [0031]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Suetsugu et al (AU 2019315179 B2).
Regarding claim 1, Suetsugu teaches insertion of a linear DNA into the circular DNA by a ligation method, such as recombination assembly (denoted as “RA”) of the DNA molecules using homologous end sequence and amplification of the circular DNA following insertion by replication cycle reaction [0018] and (Page 1, Figure 1). Suetsugu teaches the recombination assembly comprises the ligation reaction is performed by incubating the reaction solution, which is prepared by adding two or more DNA fragments, a RecA recombinant enzyme protein, a nucleoside triphosphate, an exonuclease and a magnesium ion source [0069]. Suetsugu teaches the RA method comprising mixing a 9.5 kb plasmid (pOri8), Cas9, RNase inhibitor murine, and an R8 buffer (added to bring the total volume of the mixture up to 10 μL) (composition as shown in Table 2) were mixed, and the resulting mixture was incubated at 30°C for 30 minutes following with the restriction enzyme SacI (in the case of pOri8) was added, and the mixture was incubated at 37°C for one hour [0250]. Suetsugu teaches, as illustrated in FIG. 2B, the pOri8 supercoiled DNA was cleaved and linearized dependent on the gRNA_Km having a recognition sequence downstream from a kanamycin resistance gene and the result of the SacI treatment revealed that, as expected, cleavage of the 9.5 kb fragment produced fragments of 5.6 kb and 3.8 kb [0251].
Regarding claim 2, Suetsugu teaches the double-stranded DNA fragment is first trimmed by an exonuclease to convert the homologous region to a single-stranded form, and the ligation reaction is then conducted in the presence of the RecA family recombinase protein, the ligation efficiency is extremely good [0039].
Regarding claim 3, Suetsugu teaches the length of the homologous region is 50 bases or less [0069].
Regarding claim 4, Suetsugu teaches the reaction temperature of the ligation reaction is
within a temperature range from 27°C to 33°C [0069].
Regarding claim 5, Suetsugu teaches in the RA method, gaps and nicks in the obtained ligation product are preferably repaired using gap repair enzymes and dNTP following completion of the ligation reaction and by repairing these nicks, the ligation product can be converted to a complete double-stranded DNA [0070].
Regarding claims 6-9, Suetsugu teaches uses the R8 buffer comprising Tris-Rd (pH 8.0), KOAc, Mg(OAc)2, DTT, Creatine phosphate, Ammonium sulfate, ATP, GTPs, CTPs, UTPs, tRNA, NAD, sNTPs, Tiron, Enzyme mixture, BSA, creatine kinase, SSB, IHF, DnaG, Clamp, PolIII, DnaB-DnaC, DnaA, RNaseH, Ligase, PolI, GyrA, GyrB, TopoIV, TopoIII, RecQ, RecG, RecJ, ExoI, ExoIII and Lambda DNA (Page 121, Table 2; [0260]).
Regarding claim 10, Suetsugu teaches insertion of a linear DNA into the circular DNA by a ligation method, such as recombination assembly (denoted as “RA”) of the DNA molecules using homologous end sequence and amplification of the circular DNA following insertion by replication cycle reaction [0018] and (Page 1, Figure 1).
Regarding claim 11, Suetsugu teaches insertion of a linear DNA into the circular DNA by a ligation method, such as recombination assembly (denoted as “RA”) of the DNA molecules using homologous end sequence and amplification of the circular DNA following insertion by replication cycle reaction [0018] and (Page 1, Figure 1). Suetsugu teaches the recombination assembly comprises the ligation reaction is performed by incubating the reaction solution, which is prepared by adding two or more DNA fragments, a RecA recombinant enzyme protein, a nucleoside triphosphate, an exonuclease and a magnesium ion source [0069]. Suetsugu teaches the RA method comprising mixing a 9.5 kb plasmid (pOri8), Cas9, RNase inhibitor murine, and an R8 buffer (added to bring the total volume of the mixture up to 10 μL) (composition as shown in Table 2) were mixed, and the resulting mixture was incubated at 30°C for 30 minutes following with the restriction enzyme SacI (in the case of pOri8) was added, and the mixture was incubated at 37°C for one hour [0250]. Suetsugu teaches, as illustrated in FIG. 2B, the pOri8 supercoiled DNA was cleaved and linearized dependent on the gRNA_Km having a recognition sequence downstream from a kanamycin resistance gene and the result of the SacI treatment revealed that, as expected, cleavage of the 9.5 kb fragment produced fragments of 5.6 kb and 3.8 kb [0251]. Suetsugu teaches the method of the present invention includes the following steps: (111-1) a step of forming a reaction mixture of a circular DNA that represents the template, and a reaction solution containing: a first enzyme group that catalyzes replication of the circular DNA, a second enzyme group that catalyzes an Okazaki fragment ligation reaction and synthesizes two sister circular DNAs that form a catenane, and a third enzyme group that catalyzes a separation reaction of the two sister circular DNAs; and (III-2) a step of reacting the reaction mixture formed in step (III-1), wherein the circular DNA contains a replication origin sequence (origin of chromosome (oriC)) that can bind to an enzyme having DnaA activity [0167]. Suetsugu teaches the nicks in the ligation product can be repaired by adding dNTP to the reaction solution following the ligation reaction, and then incubating the resulting mixture for a predetermined time under isothermal conditions at a temperature at which the nick repair enzymes can exert enzyme activity [0071].
Regarding claim 12, Suetsugu teaches insertion of a linear DNA into the circular DNA by a ligation method, such as recombination assembly (denoted as “RA”) of the DNA molecules using homologous end sequence and amplification of the circular DNA following insertion by replication cycle reaction [0018] and (Page 1, Figure 1). Suetsugu teaches the recombination assembly comprises the ligation reaction is performed by incubating the reaction solution, which is prepared by adding two or more DNA fragments, a RecA recombinant enzyme protein, a nucleoside triphosphate, an exonuclease and a magnesium ion source [0069]. Suetsugu teaches the RA method comprising mixing a 9.5 kb plasmid (pOri8), Cas9, RNase inhibitor murine, and an R8 buffer (added to bring the total volume of the mixture up to 10 μL) (composition as shown in Table 2) were mixed, and the resulting mixture was incubated at 30°C for 30 minutes following with the restriction enzyme SacI (in the case of pOri8) was added, and the mixture was incubated at 37°C for one hour [0250]. Suetsugu teaches, as illustrated in FIG. 2B, the pOri8 supercoiled DNA was cleaved and linearized dependent on the gRNA_Km having a recognition sequence downstream from a kanamycin resistance gene and the result of the SacI treatment revealed that, as expected, cleavage of the 9.5 kb fragment produced fragments of 5.6 kb and 3.8 kb [0251].
Regarding claim 13, Suetsugu teaches the RA method comprising mixing a 9.5 kb plasmid (pOri8), Cas9, RNase inhibitor murine, and an R8 buffer (added to bring the total volume of the mixture up to 10 μL) (composition as shown in Table 2) were mixed, and the resulting mixture was incubated at 30°C for 30 minutes following with the restriction enzyme SacI (in the case of pOri8) was added, and the mixture was incubated at 37°C for one hour [0250]. Suetsugu teaches, as illustrated in FIG. 2B, the pOri8 supercoiled DNA was cleaved and linearized dependent on the gRNA_Km having a recognition sequence downstream from a kanamycin resistance gene and the result of the SacI treatment revealed that, as expected, cleavage of the 9.5 kb fragment produced fragments of 5.6 kb and 3.8 kb [0251].
Regarding claim 14, Suetsugu teaches that the pOri8 was prepared by the following method and is a circular double stranded DNA plasmid [0018 and 0249].
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ROSE LIPPOLIS whose telephone number is (703)756-5450. The examiner can normally be reached Monday-Friday, 8:00am to 5:00pm EST.
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/ALEXANDRA ROSE LIPPOLIS/Examiner, Art Unit 1637
/CELINE X QIAN/Primary Examiner, Art Unit 1637
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