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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/30/2026 has been entered.
Claims 17, 19-23, 25-30 and 36 are pending. Claims 28, 29 and 36 are withdrawn. Claims 17, 19-23, 25-27 and 30 are currently under examination.
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.
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Claim 17, 19-23, 25-27 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 of U.S. Patent No. 11,441,132 in view of Jarver, Craig and Yant. This rejection is rewritten to address the amendment.
Claims 1-9 of the ‘132 patent claims a transposase or transposon system comprises a transposase having at least 90% sequence identity to SEQ ID NO: 2 but with at least one of mutated amino acid at 176 or 212, C176S and I212S. This transposase anticipates the transposase claimed in present application claims 17-21, 30.
The ‘132 patent does not teach coupling the transposase to a linker, wherein the linker may be biotin-streptavidin combination, or covalently couple the transposase to a protein.
Jarver teaches co-transduction of SB transposase and donor plasmid via a cell-penetrating peptide (CPP) (abstract). Jarver teaches M918 is a potent vector for co-uptake of both SB and transposon donor plasmid, and this simple one step peptide mediated uptake might be a suitable method for safe and efficient non-viral gene therapy (page 63, 1st col., last paragraph). Jarver teaches transposase and plasmid were incubated for 25 min, and then CPPs were added, wherein transposase/plasmid mixture are incubated for an additional 25 min prior to peptide transfection (page 60, 2nd col., 1st paragraph), which meets the limitation of a preassembled extracellular shuttle complex that is configured for translocation of a cargo compound into the target cell (see also page 59, Figure 1 and legend).
Craig teaches transposase mutants and transposon end for modifying nucleic acid and methods use said system (abstract). Craig teaches coupling biotinylated transposon to streptavidin coated magnetic beads (Figure 9).
Yant teaches a fusion protein that comprises a transposase and a site-specific DNA binding protein (claim 3, page 22), and a method of integrating an exogenous nucleic acid into a targeted region using said transposase fusion protein (claim 7).
It would have been obvious that CPP taught by Jarver and biotin-streptavidin combination may both be linkers to transposase claimed in ‘132 patent depending on how the transposon system will be delivered. As demonstrated by Jarver, CPP is efficient for delivering both transposase protein and the cargo plasmid. Similarly, a different type of cargo may be coupled to transposase through biotin-streptavidin linker. It would also have been obvious that a fusion protein comprising a DNA binding protein (a cargo) and the transposase claimed in ‘132 patent as taught by Yant may also be delivered to mammalian cell via preassembled complex that comprises the transposase protein and a nucleic acid vector. Regarding claim 30, the teaching from Jarver does not involve any other “procedure” besides incubating the preassembled complex with the cell. Therefore, the claimed invention of claims 17, 19-23, 25-27 and 30 would have been obvious in view of the modified transposase claimed in claims 1-9 of the ‘132 patent.
Claims 17, 19-23, 25-27 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 10 of U.S. Patent No. 12,270,055 in view of Jarver, Craig and Yant. This rejection is rewritten to address the amendment.
Claims 1-5 and 10 of the ‘055 patent claims a transposase or transposon system comprises a transposase having at least 90% sequence identity to SEQ ID NO: 2 but with at least one of mutated amino acid at 176 or 212, C176S and I212S. This transposase anticipates the transposase claimed in present application claims 17, 19-21 and 30.
The ‘055 patent does not teach coupling the transposase to a linker, wherein the linker may be biotin-streptavidin combination, or covalently couple the transposase to a protein.
Jarver teaches co-transduction of SB transposase and donor plasmid via a cell-penetrating peptide (CPP) (abstract). Jarver teaches M918 is a potent vector for co-uptake of both SB and transposon donor plasmid, and this simple one step peptide mediated uptake might be a suitable method for safe and efficient non-viral gene therapy (page 63, 1st col., last paragraph). Jarver teaches transposase and plasmid were incubated for 25 min, and then CPPs were added, wherein transposase/plasmid mixture are incubated for an additional 25 min prior to peptide transfection (page 60, 2nd col., 1st paragraph), which meets the limitation of a preassembled extracellular shuttle complex that is configured for translocation of a cargo compound into the target cell (see also page 59, Figure 1 and legend).
Craig teaches transposase mutants and transposon end for modifying nucleic acid and methods use said system (abstract). Craig teaches coupling biotinylated transposon to streptavidin coated magnetic beads (Figure 9).
Yant teaches a fusion protein that comprises a transposase and a site-specific DNA binding protein (claim 3, page 22), and a method of integrating an exogenous nucleic acid into a targeted region using said transposase fusion protein (claim 7).
It would have been obvious that CPP taught by Jarver and biotin-streptavidin combination may both be linkers to transposase claimed in ‘055 patent depending on how the transposon system will be delivered. As demonstrated by Jarver, CPP is efficient for delivering both transposase protein and the cargo plasmid. Similarly, a different type of cargo may be coupled to transposase through biotin-streptavidin linker. It would also have been obvious that a fusion protein comprising a DNA binding protein (a cargo) and the transposase claimed in ‘055 patent as taught by Yant may also be delivered to mammalian cell by using the preassembled complex taught by Jarver. Therefore, the claimed invention of claims 17, 19-23, 25-27 and 30 would have been obvious in view of the modified transposase claimed in claims 1-5 and 10 of the ‘055 patent.
Claims 17-27, 30 and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-17 of patent US 12,371,679 in view of Jarver, Craig or Yant. This rejection is rewritten to address the amendment.
Claims 14-17 of the ‘679 patent claims method of inserting a transgene into the genome of a living host cell, which uses a transposon system comprises a transposase having at least 90% sequence identity to SEQ ID NO: 2 but with at least one of mutated amino acid at 176 or 212, C176S and I212S, wherein the transposase is in protein form in combination with a transposon that contains a transgene. This transposase/transposon combination anticipates the preassembled shuttle complex claimed in present application claims 17-21 and 30 because transposase and transposon forms complex.
The ‘679 patent does not teach coupling the transposase to a linker, wherein the linker may be biotin-streptavidin combination, or covalently couple the transposase to a protein.
Jarver teaches co-transduction of SB transposase and donor plasmid via a cell-penetrating peptide (CPP) (abstract). Jarver teaches M918 is a potent vector for co-uptake of both SB and transposon donor plasmid, and this simple one step peptide mediated uptake might be a suitable method for safe and efficient non-viral gene therapy (page 63, 1st col., last paragraph). Jarver teaches transposase and plasmid were incubated for 25 min, and then CPPs were added, wherein transposase/plasmid mixture are incubated for an additional 25 min prior to peptide transfection (page 60, 2nd col., 1st paragraph), which meets the limitation of a preassembled extracellular shuttle complex that is configured for translocation of a cargo compound into the target cell (see also page 59, Figure 1 and legend).
Craig teaches transposase mutants and transposon end for modifying nucleic acid and methods use said system (abstract). Craig teaches coupling biotinylated transposon to streptavidin coated magnetic beads (Figure 9).
Yant teaches a fusion protein that comprises a transposase and a site-specific DNA binding protein (claim 3, page 22), and a method of integrating an exogenous nucleic acid into a targeted region using said transposase fusion protein (claim 7).
It would have been obvious that CPP taught by Jarver and biotin-streptavidin combination may both be linkers to transposase claimed in ‘679 patent depending on how the transposon system will be delivered. As demonstrated by Jarver, CPP is efficient for delivering both transposase protein and the cargo plasmid. Similarly, a different type of cargo may be coupled to transposase through biotin-streptavidin linker. It would also have been obvious that a fusion protein comprising a DNA binding protein (a cargo) and the transposase claimed in ‘670 patent may also be delivered to mammalian cell in protein form as described by Jarver. Therefore, the claimed invention of claims 17, 19-23, 25-27 and 30 would have been obvious in view of the modified transposase claimed in claims 14-17 of the ‘679 patent.
Response to Arguments
Applicant argues that the claims of ‘132, ‘055 and ‘679 patent do not refer to coupling a cargo to a modified Sleeping Beauty transposase outside a target cell to form a shuttle complex, and using the modified transposase protein to shuttle the cargo into the cell as claimed, and the secondary references do not cure the deficiencies.
The above argument has been considered but deemed unpersuasive. As discussed in the above rewritten rejection, Jarver teaches delivering transposase in protein form, coupled with transgene vector (the cargo), wherein the combination was incubated together prior to introduction into the cell. It would have been obvious to an ordinary skilled in the art that this modified transposase claimed in ‘132 and ‘055 patent may also deliver transgene (cargo) as taught by Jarver. The ‘679 patent recites method of delivering the modified transposase in protein form in combination with transposon comprising a transgene. Therefore, the above rejections are still considered proper and thus maintained.
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/CELINE X QIAN/ Primary Examiner, Art Unit 1637
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