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 .
Claim Status
Claims 1, 2, 4, 6-8, 16, 18 and 25-32 are pending and examined. Claims 3, 5, 9-15, 17 and 19-24 have been cancelled.
Drawings
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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).
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Claims 1, 2, 4, 6-8, 16, 18 and 25-32 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9, 11 and 13-15 of U.S. Patent No. 12,522,864 B2 (referred to herein as ‘864). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 1, 2, 4, 6-8, 16, 18 and 25-32 are drawn to a process for the production of a closed linear DNA comprising the steps of: a) providing a closed linear DNA template comprising a DNA sequence of interest, wherein the closed linear DNA template does not comprise a single-stranded loop comprising a primase/polymerase priming site; b) amplifying DNA from the closed linear DNA template of step (a) wherein the amplification is primed with a primase/polymerase enzyme of SEQ ID NO: 1 wherein the amplification a rolling circle amplification or with a strand displacement DNA polymerase wherein a vector comprising at least two restriction sites flanking the DNA sequence of interest is contacted with a restriction enzyme producing open double stranded DNA and attaching single stranded DNA adaptors to both ends wherein or the plasmid vector is contacted with two protelomerases, wherein the sequence of interest comprises ITRs, wherein the process is a cell-free in vitro process,
Meanwhile, ‘864 claims A process for the production of a closed linear DNA comprising the steps of: a) providing a closed linear DNA template comprising a double-stranded middle segment comprising a DNA sequence of interest flanked by two single-stranded loops, wherein the single-stranded loops do not comprise a primase/polymerase priming site; b) amplifying DNA from the closed linear DNA template of step (a) wherein the amplification is primed with a primase/polymerase enzyme of SEQ ID NO:1; c) generating a closed linear DNA with the amplified DNA produced in step (b); and d) purifying the closed linear DNA produced in step (c), wherein the amplification performed in step (b) is a rolling-circle amplification, wherein the amplification of step (b) is carried out with a strand displacement DNA polymerase, herein step (a) is performed by contacting a plasmid vector comprising at least two restriction sites flanking the DNA sequence of interest with at least one restriction enzyme thereby producing open double stranded DNA containing the DNA sequence of interest, and attaching single stranded DNA adaptors to both ends of the open double stranded DNA containing the DNA sequence of interest, wherein step (a) is performed by contacting a plasmid vector comprising at least two protelomerase target sequences flanking the DNA sequence of interest with a protelomerase, wherein the amplified DNA resulting from step (b) is a concatameric DNA comprising repeats of the DNA sequence of interest, wherein each one of the repeated DNA sequences of interest is flanked by restriction sites and/or protelomerase target sequences, wherein the sequence of interest comprises inverted terminal repeats (ITRs) and an expression cassette, wherein the expression cassette is flanked by the inverted terminal repeats (ITRs) wherein the process is a cell-free in vitro process and a pharmaceutical composition comprising a therapeutically effective amount of the closed linear DNA according to claim 14 and a pharmaceutically acceptable carrier or an excipient.
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive at the instantly claimed invention because ‘864 teaches a process to produce clDNA using SEQ ID NO: 1, and because as is the process in ‘864, the instantly claimed process also requires a sequence of interest flanked by two single stranded loops as it is clDNA.
Conclusion
No claim is allowed.
The closest prior art is Hill (Patent No. US 9,109,250 B2) in view of Pricher et al (Patent No US 11,299,718 B2) and Serantes et al (Pub. No. US 2020/0362403 A1), and in further view of Xiao et al (1997, Journal of Virology, 71:941-948).
Hill teaches an in vitro process for the production of closed linear DNA that comprises contacting a DNA template comprising an expression cassette flanked on either side by at least one protelomerase target sequence with at least one DNA polymerase to amplify the template and contacting said amplified DNA with a protelomerase promoting the production of clDNA, wherein said process is cell-free, wherein said amplification is by way of RCA and wherein said process comprises formulating said DNA in a pharmaceutically acceptable carrier (Abstract; see claim 1, 5, 6, 7, 8, 9, 10, 11; see also Figure 4; see col. 10, penultimate ¶).
Hill teaches that the process allows for enhanced production of linear covalently clDNA and significantly increases process productivity while reducing the cost of product purification of clDNA which have particular utility for therapeutic applications as they have improved stability and safety over other forms of DNA (col. 1, ¶ 4 and penultimate ¶).
Hill teaches the preferred displacement type polymerase is Phi29 for RCA and that an exemplary protelomerase is TelN and that the amplified DNA may be purified (col. 13, ¶ 1 and 3; see col. 16, ¶ 1; col. 20, ¶ 3). Hill teaches, in fact, the production of clDNA (e.g., see Examples 1-4).
Picher et al claim a method for replicating or amplifying DNA in the absence of primers comprising providing SEQ ID NO: 1 having both polymerase and primase activity and having 100% sequence identity to SEQ ID NO: 1 of the instant invention:
SEQ ID NO 1
LENGTH: 293
TYPE: PRT
ORGANISM: Thermus thermophilus
Query Match 100.0%; Score 1557; Length 293;
Best Local Similarity 100.0%;
Matches 293; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MRPIEHALSYAAQGYGVLPLRPGGKEPLGKLVPHGLKNASRDPATLEAWWRSCPRCGVGI 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MRPIEHALSYAAQGYGVLPLRPGGKEPLGKLVPHGLKNASRDPATLEAWWRSCPRCGVGI 60
Qy 61 LPGPEVLVLDFDDPEAWEGLRQEHPALEAAPRQRTPKGGRHVFLRLPEGVRLSASVRAIP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 LPGPEVLVLDFDDPEAWEGLRQEHPALEAAPRQRTPKGGRHVFLRLPEGVRLSASVRAIP 120
Qy 121 GVDLRGMGRAYVVAAPTRLKDGRTYTWEAPLTPPEELPPVPQALLLKLLPPPPPPRPSWG 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GVDLRGMGRAYVVAAPTRLKDGRTYTWEAPLTPPEELPPVPQALLLKLLPPPPPPRPSWG 180
Qy 181 AVGTASPKRLQALLQAYAAQVARTPEGQRHLTLIRYAVAAGGLIPHGLDPREAEEVLVAA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 AVGTASPKRLQALLQAYAAQVARTPEGQRHLTLIRYAVAAGGLIPHGLDPREAEEVLVAA 240
Qy 241 AMSAGLPEWEARDAVRWGLGVGASRPLVLESSSKPPEPRTYRARVYARMRRWV 293
|||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 AMSAGLPEWEARDAVRWGLGVGASRPLVLESSSKPPEPRTYRARVYARMRRWV 293
The method comprises providing a second polymerase such as Phi29 and a template nucleic acid (see claims 1 and 4). Pricher et al teaches that the ThtPrimPol as encompassed by SEQ ID NO: 1 is able to prime DNA for subsequent amplification by Phi2, and that RCA uses Phi29 for the amplification and covalently closed circular DNA and may also be used with SEQ ID NO: 1 (see col. 24, Example 8; see also col. 25, Example 11).
Pricher et al teach this enzyme solves the prior art need for new thermostable highly processive polymerases which can work at high temperatures without the need of additional proteins and which can amplify unknown DNA templates of often poor quality (col. 2, ¶ 5-8).
Thus, Pricher et al reasonably teaches, suggests and provides motivation for using SEQ ID NO: 1 as a priming step in the amplification of DNA templates of interest.
Similarly to both Hill and Pricher et al, Serantes et al claim a method for amplifying DNA comprising providing linear dsRNA and attaching adaptors through ligation to both ends to produce single stranded covalently closed DNA molecules and amplifying said molecules by RCA and wherein the method comprise using TthPrimPol and Phi29 and wherein said DNA is isolated (Abstract; see claims 1, 16, 21-24 and 42). The adaptors may comprise primase/polymerase recognition sequences (claim 12; see also ¶ 0055).
Xiao et al teach that ITRs can be placed at either end of sequence of interest and can be used as a substrate for synthetic plasmid vector delivery (Abstract; see also p. 947, col. 1, last ¶).
However, none of the aforementioned references reasonably teach, suggest or provide motivation for a closed linear DNA template that does not comprise a primase/polymerase priming site.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON DEVEAU-ROSEN whose telephone number is (571)272-2828. The examiner can normally be reached 7:30am - 4pm.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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