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 .
Claim status
Applicant’s submission filed 02/02/2026 has been received and entered. Claims 1, 3, 6, 15, 41, 49 and 68 have been amended. Accordingly, claims 1-7, 15, 24-26, 28, 41-43, 49, 51, 65-66 and 68 are pending and under current examination.
Status of Prior Rejection/Response to Arguments
The objection to Abstract is withdrawn:
The objection to the abstract of the disclosure has been withdrawn due to applicant’s amendment to the abstract and submitted as a single paragraph on a separate sheet as required.
The objection to Specification is withdrawn:
Applicant’s amendment to specification obviates the current objection on record. The objection is withdrawn.
The objection to Drawing is withdrawn:
Applicant’s submission of replacement sheets is effective to obviate the prior basis of the objection. The objection is withdrawn.
The objection to claims 15 and 49 is withdrawn:
Applicant’s amendment to claims 15 and 49 obviates the current objection on record. The objection is withdrawn.
The rejection to claims 1-7, 15, 24-26, 28, 41-43, 49, 51, 65, 66 and 68 under 35 U.S.C. 112(b) is withdrawn:
Applicant’s amendment to claims 1 and 41 deleting “or a variant thereof”, to claim 3 specifying the sequence of the modified Rep protein, to claim 41 limiting “the second nucleic acid construct”, as well as to claim 68 limiting the “nucleic acid construct” of claim 1, which is effective to obviate the prior basis of the rejection. The rejection is withdrawn.
The rejection to claims 1-7, 15, 24-26, 28, 41-43, 49, 51, 65, 66 and 68 under 35 U.S.C. 112(a) written description is withdrawn:
Applicant’s amendment to claims 1 and 41 deletes the phrase “or a variant thereof”. The amended claims are limiting the first or second regulatable promoter is a forskolin inducible promoter comprising SEQ ID NO: 4, 5, or 6, or a hypoxia inducible promoter comprising SEQ ID NO: 1, 2, or 3. The claims are supported by the Specification. Therefore the amendment obviates the prior basis of the rejection. The rejection is withdrawn.
The rejection to claims 1, 15, 24-26, 28, 41-43, 49, 51, 65, 66 and 68 under 35 U.S.C. 103 over Kotin in view of Whyteside, as evidenced by Juchheim is withdrawn:
The rejection to claims 1-6, 15, 24-26, 28, 41-43, 49, 51, 65, 66 and 68 under 35 U.S.C. 103 over Kotin in view of Whyteside, as evidenced by Juchheim, and further in view of Weger et al. is withdrawn:
The rejection to claims 1-7, 15, 24-26, 28, 41-43, 49, 51, 65, 66 and 68 under 35 U.S.C. 103 over Kotin in view of Whyteside, as evidenced by Juchheim, and further in view of Mengesha et al. is withdrawn:
Applicant’s amendment to claims 1 and 41 deletes the limitation “or a variant thereof”. Applicant asserts that none of the cited references teach or suggest at least one promoter has a sequence consisting of SEQ ID NO: 1-6, as required by the claims as amended (Remarks, p3).
Applicant’s argument is found persuasive. Specifically, the amended claims are limiting the first or second regulatable promoter is a forskolin inducible promoter which comprises a nucleic acid sequence of SEQ ID NOs 4, 5, or 6; or a hypoxia inducible promoter which comprises a nucleic acid sequence of SEQ ID NO: 1, 2, or 3. None of the prior arts teaching a nucleic acid sequence which is 100% identical to SEQ ID NOs 1-6, therefore Applicant’s amendment is sufficient to overcome the rejection on record. The rejection is withdrawn.
New grounds of rejection are set forth as necessitated by Applicant’s amendment.
New Grounds of Claim Rejections
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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Claims 1-7, 15, 24-26, 28, 41-43, 49, 51, 65-66 and 68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 15, 23, 26, 28, 41-43, 49, 51 and 65-68 of copending Application No. 17/907,229 in view of Kotin (WO 2017/075335 A1, cited in IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims render obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. This rejection is necessitated by Applicant’s amendment to co-pending application.
Regarding instant claims 1-7 and 68, co-pending claims 1-4, 6 and 68 disclose a nucleic acid construct comprising a nucleic acid sequence encoding a E4 protein, a nucleic acid sequence encoding a E2A protein, or a nucleic acid sequence encoding a VA RNA, wherein each nucleic acid sequences encoding any one of E4 protein, E2A protein, and VA RNA is operatively linked to a first regulatable promoter; and a nucleic acid sequence encoding a Rep protein, wherein the nucleic acid encoding a Rep protein is under the control of a second regulatable promoter or heterologous transcriptional activator, wherein the first and the second regulatable promoters are different, wherein the second regulatable promoter is a forskolin inducible promoter or a hypoxia inducible promoter, wherein the forskolin inducible promoter does not have a sequence of SEQ ID NO: 146-147, and the hypoxia forskolin inducible promoter does not have a sequence of SEQ ID NO: 2, 4, 5. Co-pending claims teach all the elements of instant claims, including a nucleic acid sequence encoding a E4 protein, a E2A protein, and/or a VA RNA, and a nucleic acid sequence encoding a Rep protein, as well as the regulatable promoters are forskolin inducible promoters and/or hypoxia inducible promoters. Though the forskolin inducible promoters and/or hypoxia inducible promoters have different nucleic acid sequences, they are all forskolin inducible promoters and hypoxia inducible promoters, which can be induced by forskolin or hypoxia to regulate gene expression in the construct. In addition, co-pending claim 6 teaches the forskolin inducible promoter has a nucleic acid sequence of SEQ ID NO 145, which is 100% identical to SEQ ID NO: 4 as recited in instant claim 1.
Regarding instant claims 15, 24-26 and 28, following the discussion above, co-pending claims 15, 23, 26 and 28 disclose a cell comprising the nucleic acid construct, and the cell further comprising a nucleic acid construct comprising a nucleic acid sequence encoding a marker protein, the marker protein is flanked by recombinase recognition sequences (RRS), as well as the expression of the nucleic acid construct in the cell is a stable expression or a transient expression. Co-pending claims do not teach the cell comprising the nucleic acid is a cell such as HEK293 cell. However, this was disclosed by Kotin. Kotin teaches compositions, methods and processes for the design, preparation, manufacture and/or formulation of recombinant parvovirus, e.g. adeno-associated virus (AAV), particles having one or more regulatable elements and methods of using the same (parag 0003). Kotin teaches regulatable-AAV particles comprising at least one regulatable element to regulate the expression of a transgene or gene (parag 0010), Kotin teaches a viral replication cell may be selected from any biological organism, including prokaryotic (e.g., bacterial) cells, and eukaryotic cells, including, insect cells, yeast cells and mammalian cells. Viral replication cells may comprise mammalian cells such as HEK293, A549 … Saos, C2Cl2, L cells, HT1080, HepG2 and primary fibroblast, hepatocyte and myoblast cells derived from mammals (parag 00431). It would have been prima facie obvious to modify the cell in the co-pending claims, which comprises a nucleic acid construct comprising a nucleic acid sequence encoding a E4 protein, a E2A protein, and/or a VA RNA, and a nucleic acid sequence encoding a Rep protein, as well as the regulatable promoters comprising forskolin inducible promoters and/or hypoxia inducible promoters, and produce the viral vector in a HEK 293 cell as taught by Kotin. The skilled artisan would have been motivated to use a cell such as HEK293 cell for the viral product since Kotin teaches the viral replication cells may be mammalian cells such as HEK293 (parag 00431). There would be a reasonable expectation of success of using a HEK 293 cell since Kotin teaches using HEK293 cells for viral production (see i.e., p179, Example 3).
Regarding instant claims 41-43 and 49, following the discussion above, co-pending claims 41-43 and 49 disclose a nucleic acid construct comprising a nucleic acid construct comprising elements in a 5’ to 3’ direction, which teach all the limits of instant claims, including a nucleic acid sequence encoding a E4 protein, a E2A protein, and/or a VA RNA, and a nucleic acid sequence encoding a Rep protein, as well as the regulatable promoter of the second nucleic acid construct is a forskolin inducible promoter or a hypoxia inducible promoter. Though co-pending claims teach the forskolin inducible promoters or hypoxia inducible promoters have different nucleic acid sequences, they are all forskolin inducible promoters and hypoxia inducible promoters, which can be induced by forskolin or hypoxia to regulate gene expression in the nucleic acid expression constructs.
Regarding instant claims 51 and 65-66, co-pending claims 51 and 65-67 teach a method of producing viral particles, the co-pending claims disclose same steps in the method as instant claims, which render obvious to instant claims.
Related Prior Arts
Instant claims are directed to a nucleic acid construct comprising: a nucleic acid sequence comprising at least one of: a nucleic acid sequence encoding a E4 protein, a nucleic acid sequence encoding a E2A protein, and a nucleic acid sequence encoding a VA RNA, wherein each nucleic acid sequences encoding any one of E4 protein, E2A protein, and VA RNA is operatively linked to a first regulatable promoter; and a nucleic acid sequence encoding a Rep protein, wherein the nucleic acid encoding a Rep protein is under the control of a second regulatable promoter or heterologous transcriptional activator, wherein the first and the second regulatable promoters are different, wherein at least the first or second regulatable promoter is selected from the group consisting of a forskolin inducible promoter selected from SEQ ID NO: 4-6 and a hypoxia inducible promoter selected from SEQ ID NO: 1-3. Kotin is considered as the closet art. Kotin teaches regulatable-AAV particles comprising at least one regulatable element to regulate the expression of a transgene or gene (parag 0010). Kotin teaches the regulatable-AAV particle comprises E2A (parag 0217) and E2A can be operatively linked to a first regulatable promoter (parag 00109). Kotin also teaches the regulatable-AAV particle comprises rep and/or cap gene sequences under the control of one or more regulatable elements to produce a viral construct expression vector (parag 0015). However, Kotin does not teach a forskolin inducible promoter and/or a hypoxia inducible promoter, as well as the sequences of the inducible promoters. Whyteside teaches an inducible promoter which can be induced by forskolin and hypoxia (i.e., SEQ ID NO:22, p14, L25-29), but does not teach the inducible promoter has a sequence that 100% identical to any SEQ ID NO:1-6 as recited in instant claims. Moreover, the nucleic acid sequence of the inducible promoters that 100% identical to any of SEQ ID NOs 1-6 is found free of art. Therefore the claimed nucleic acid construct which comprising the nucleic acid sequence 100% identical to any of SEQ ID NOs 1-6 is found novel.
Conclusion
No claims are allowed.
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.
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/Q.G./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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