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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/06/2026 has been entered.
This action is in response to the amendment filed 04/06/2026, in which claims 139, 151, 152, 196, 201 and 208 were amended, claims 197 and 202-205 were previously presented and claims 199, 200 and 211 were canceled. Claims 139, 151, 152, 196-197, 201-205 and 208 are currently pending.
Applicant’s arguments have been thoroughly reviewed, but are not persuasive for the
reasons that follow. Any rejection and objections not reiterated in this action have been
withdrawn.
Information Disclosure Statement
Receipt of acknowledgment of the information disclosure statement filed on 04/06/2026 have been received and all references have been considered.
Claim Objections
The previous objection of claim 211 has been withdrawn in view of Applicant’s cancelation of the claim filed on 04/06/2026.
Claim Rejections - 35 USC § 112
The previous rejection of claim 208 under 35 U.S.C. 112(b) has been withdrawn in view of Applicant’s amendments to the claims filed on 04/06/2026.
The previous rejection of claim 200 under 35 U.S.C. 112(d) has been withdrawn in view of Applicant’s cancelation of the claim filed on 04/06/2026.
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 139, 196, 197, 201-205 and 208 are rejected under 35 U.S.C. 103 as being unpatentable over Bieniossek et al (Current Protocols in Protein Science, 51: 5.20.1-5.20.26; 2008) as evidenced by DeBoy et al (Journal of Bacteriology, Vol. 182, No. 11, pgs. 3310-3313; 2000) and in view of Kerr et al (WO 2020/186207 A2) and Wang et al (J Virol. 2017 Aug 24;91(18): e00710-17; Pgs 1-18). This rejection was made in the Office action mailed 01/06/2026 and has been rewritten to address the amendment to the claims in the reply filed 04/06/2026.
Regarding claims 139 and 196, Bieniossek teaches a composite bacmid comprising an insert into a mini-attTn7 site located within a Lacz reporter gene, which disrupts the reading frame (Figure 5.20.2). Bieniossek teaches the insert comprises first and second heterologous sequences within multiple cloning sites (Figure 5.20.1 and Figure 5.20.2). Bieniossek teaches the composite bacmid further comprising a LoxP site for site specific recombination (Figure 5.20.2). DeBoy is cited only to provide evidence that the att-Tn7 site is duplicated upon Tn7 insertion (Figure 1). Thus, the composite bacmid of Bieniossek contains duplicated att-Tn7 sites.
Bieniossek does not teach the composite bacmid where the first heterologous gene encodes a Rep protein. Bieniossek does not teach the second heterologous gene comprises from 5' to 3': a wild-type or truncated 5' inverted terminal repeat derived from a first genome of a member of the viral family Parvoviridae; a sequence encoding a protein; one or more expression control sequences operably linked to the sequence encoding a protein; and a wild-type or truncated 3' inverted terminal repeat derived from a second genome of a member of the viral family Parvoviridae.
Kerr teaches a recombinant bacmid comprising: a reporter gene wherein the reporter gene is Lacz and a Rep protein where the Rep protein is inserted into the Lacz reporter gene disrupting the gene expression [00525]. Kerr teaches recombination between the Rep-plasmid and a baculovirus shuttle vector in the DHl0Bac cells were induced to generate recombinant bacmids [00525]. Kerr teaches the recombinant bacmids were selected by a positive selection that included-blue-white screening in E. coli (Φ80dlacZL1Ml5 marker provides a complementation of the β-galactosidase gene from the bacmid vector) on a bacterial agar plate containing X-gal and IPTG; Isolated white colonies were picked and inoculated in 10 ml of selection media (kanamycin, gentamicin, tetracycline in LB broth) [00525]. Kerr teaches CeDNA-Baculovirus can be transiently transfected to the cells, be replicated by Rep protein and produce ceDNA vectors [00339]. Kerr teaches from 5' to 3' an expression cassette comprising: a 5' ITR, the expression control sequence operably linked to a promoter, posttranscriptional regulatory element such as woodchuck hepatitis virus (WPRE) and polyadenylation signal, and a 3' ITR (Page 269, Figure 1; [00519]). Kerr teaches an "expression cassette" includes a DNA coding sequence operably linked to a promoter [0071]. Kerr teaches expression of FVIII protein, they can include a highly active virus-derived immediate early promoter [00292]. Kerr teaches the expression control sequence comprises a 5' inverted terminal repeat and a 3' invented terminal repeat wherein the 5' ITR is derived from a parvovirus AA V2 and the 3' ITR is derived from a mutated parvovirus AAV2 (Page 269, Figure 1; [00518-00519]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bieniossek to include the heterologous sequence inserted into the reporter protein in order to disrupt the reporter function as taught by Kerr because Bieniossek teaches it is within the ordinary skill in the art to use a recombinant bacmid comprising: a first heterologous sequence inserted into a first reporter gene, wherein the inserted heterologous sequence disrupts the reading frame of the first reporter gene; a first preferential target site capable of mediating a site-specific recombination event; a multiple cloning site comprising a second heterologous sequence; and a second preferential target site capable of mediating a site-specific recombination event and Kerr teaches the use of inserting a heterologous sequence, such as a Rep protein, the disrupts the expression of the reporter protein such as the Lacz gene.
One would have been motivated to make such a modification in order to receive the expected benefit of disruption of the reporter protein allowing for transient expression as taught by Kerr.
Bieniossek and Kerr do not teach wherein the Rep protein is selected from the group consisting of a B19 rep and a HBoV1 rep and wherein the sequence encoding the Rep protein is derived from a parvovirus selected from the group consisting of B19 and HBoV1.
Wang teaches HBoV1 gene products—specifically the NP1 and NS2 “Rep” proteins, alongside the BocaSR RNA—facilitate AAV DNA replication and capsid production, offering a simpler and highly efficient system for recombinant AAV (rAAV) vector production in human gene therapy (Page 1, Abstract; and Page 13, Paragraph 1). Wang teaches that the NP1, NS2 and viral RNA BocaSR are used to provide the essential proteins and environment required for AAV DNA replication and virion production (Page 3, Paragraph 2; and Page 15, Paragraph 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of the parvovirus AAV2 rep protein to include the HBoV1 NP1, NS2 and viral RNA BocaSR proteins as taught by Wang because Bieniossek teaches it is within the ordinary skill in the art to use a recombinant bacmid comprising: a first heterologous sequence inserted into a first reporter gene, wherein the inserted heterologous sequence disrupts the reading frame of the first reporter gene; a first preferential target site capable of mediating a site-specific recombination event; a multiple cloning site comprising a second heterologous sequence; and a second preferential target site capable of mediating a site-specific recombination event, Kerr teaches a recombinant bacmid comprising: a reporter gene wherein the reporter gene is LacZ and a Rep protein where the Rep protein is inserted into the LacZ reporter gene disrupting the gene expression wherein the Rep protein is derived from parvovirus and can be an AAV2 Rep and Smith teaches GPV Rep1 and AAV Rep78 support a comparable mode of replication.
Thus, substitution of the AAv2 Rep protein derived from a parvovirus of Kerr, for the GPV Rep1 protein of Smith would have been prima facie obvious to one of ordinary skill in the art, and thus the invention as claimed is unpatentable over the work of the prior art. Substitution of one known method for another known method, the methods having equivalent effect, is considered to be obvious, absent a showing that the result of the substitution yields more than predictable results. See MPEP 2143(I)(B).
Regarding claim 197, Bieniossek does not teach an expression control sequence operably linked to a sequence encoding a protein wherein the expression control sequence comprises a baculovirus promoter.
Kerr teaches an "expression cassette" includes a DNA coding sequence operably linked to a promoter [0071]. Kerr teaches expression of FVIII protein, they can include a highly active virus-derived immediate early promoter [00292].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bieniossek to include an expression control sequence operably linked to a sequence encoding a protein wherein the expression control sequence comprises a baculovirus promoter as taught by Kerr because Bieniossek teaches it is within the ordinary skill in the art to use a recombinant bacmid comprising: a first heterologous sequence inserted into a first reporter gene, wherein the inserted heterologous sequence disrupts the reading frame of the first reporter gene; a first preferential target site capable of mediating a site-specific recombination event; a multiple cloning site comprising a second heterologous sequence; and a second preferential target site capable of mediating a site specific recombination event and Kerr teaches expression of FVIII protein, that includes a highly active virus-derived immediate early promoter.
One would have been motivated to make such a modification in order to receive the expected benefit of targeted expression of the FVIII protein as taught by Kerr.
Regarding claims 201 and 202, Bieniossek does not teach the expression control sequence comprises a tissue-specific promoter, a polyadenylation signal, and/or a post-transcriptional regulatory element and wherein the tissue-specific promoter is a tristetraprolin (TTP) or a murine transthyretin (mTTR) promoter; the polyadenylation signal is a bovine growth hormone polyadenylation signal; and/or the post-transcriptional regulatory element is a woodchuck hepatitis virus post- transcriptional regulatory element (WPRE).
Kerr teaches the expression control sequence comprises a promoter, posttranscriptional regulatory element such as woodchuck hepatitis virus (WPRE) and polyadenylation signal (Page 269, Figure 1; [00519]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bieniossek to include the expression control sequence comprises a tissue-specific promoter, a polyadenylation signal, and/or a posttranscriptional regulatory element and wherein the tissue-specific promoter is a tristetraprolin (TTP) or a murine transthyretin (mTTR) promoter; the polyadenylation signal is a bovine growth hormone polyadenylation signal; and/or the post-transcriptional regulatory element is a woodchuck hepatitis virus post- transcriptional regulatory element (WPRE) as taught by Kerr because Bieniossek teaches it is within the ordinary skill in the art to use a recombinant bacmid comprising: a first heterologous sequence inserted into a first reporter gene, wherein the inserted heterologous sequence disrupts the reading frame of the first reporter gene; a first preferential target site capable of mediating a site-specific recombination event; a multiple cloning site comprising a second heterologous sequence; and a second preferential target site capable of mediating a site-specific recombination event and Kerr teaches the expression control sequence comprises a promoter, posttranscriptional regulatory element such as woodchuck hepatitis virus (WPRE) and polyadenylation signal.
One would have been motivated to make such a modification in order to receive the expected benefit of targeted expression of the FVIII protein as taught by Kerr.
Regarding claim 203-205, Bieniossek does not teach the protein is a therapeutic protein and the therapeutic protein is a clotting factor, such as Factor VIII (FVIII) or FVIIIXTEN.
Kerr teaches the ceDNA bacmid may comprise a desired FVIII protein sequence operably linked to control elements capable of directing transcription of the desired FVIII protein encoded by the exogenous DNA sequence when introduced into the subject [00418].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bieniossek to include the protein is a therapeutic protein and the therapeutic protein is a clotting factor, such as Factor VIII (FVIII) or FVIII-XTEN as taught by Kerr because Bieniossek teaches it is within the ordinary skill in the art to use a recombinant bacmid comprising: a first heterologous sequence inserted into a first reporter gene, wherein the inserted heterologous sequence disrupts the reading frame of the first reporter gene; a first preferential target site capable of mediating a site-specific recombination event; a multiple cloning site comprising a second heterologous sequence; and a second preferential target site capable of mediating a site-specific recombination event and Kerr teaches the ceDNA bacmid may comprise a desired FVIII protein sequence operably linked to control elements capable of directing transcription of the desired FVIII protein encoded by the exogenous DNA sequence when introduced into the subject.
One would have been motivated to make such a modification in order to receive the expected benefit of targeted expression of the FVIII protein as taught by Kerr.
Regarding claim 208, Bieniossek does not teach the first and second genome are the same or different; the 5’ ITR and the 3’ ITR are derived from a parvovirus selected from the group consisting of B19, GPV and HBoV1; the 5’ ITR is a wild-type or truncated 5’ ITR derived from B19, GPV or HBoV1; and/or the 3’ ITR is a wild-type or truncated 3’ ITR derived from B19, GPV or HBoV1.
Kerr teaches the use of the ITR derived from a Parvovirus B19 [00232]. Kerr teaches from 5’ to 3’ an expression cassette comprising: a 5’ ITR (wherein the 5’ ITR is a wildtype or mutant), the expression control sequence operably linked to a promoter, posttranscriptional regulatory element such as woodchuck hepatitis virus (WPRE) and polyadenylation signal, and a 3’ ITR (wherein the 3’ ITR is a wildtype or mutant) (Page 269, Figure 1; [00519]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bieniossek to the first and second genome are the same or different; the 5’ ITR and the 3’ ITR are derived from a parvovirus selected from the group consisting of B19, GPV and HBoV1; the 5’ ITR is a wild-type or truncated 5’ ITR derived from B19, GPV or HBoV1; and/or the 3’ ITR is a wild-type or truncated 3’ ITR derived from B19, GPV or HBoV1 as taught by Kerr because Bieniossek teaches it is within the ordinary skill in the art to use a recombinant bacmid comprising: a first heterologous sequence inserted into a first reporter gene, wherein the inserted heterologous sequence disrupts the reading frame of the first reporter gene; a first preferential target site capable of mediating a site-specific recombination event; a multiple cloning site comprising a second heterologous sequence; and a second preferential target site capable of mediating a site-specific recombination event and Kerr teaches the use of the ITR derived from a Parvovirus B19 wherein the expression cassette has a sequence from 5’ to 3’ comprising: a 5’ ITR (wherein the 5’ ITR is a wildtype or mutant), the expression control sequence operably linked to a promoter, posttranscriptional regulatory element such as woodchuck hepatitis virus (WPRE) and polyadenylation signal, and a 3’ ITR (wherein the 3’ ITR is a wildtype or mutant).
One would have been motivated to make such a modification in order to receive the expected benefit of targeted expression with expression control sequences such as ITRs derived from parvovirus as taught by Kerr.
Response to Arguments - Claim Rejections - 35 USC § 103
The previous rejection of claims 139 196, 197, 201-205 and 208 under 35 U.S.C. 103 over Bieniossek et al (Current Protocols in Protein Science, 51: 5.20.1-5.20.26; 2008) as evidenced by DeBoy et al (Journal of Bacteriology, Vol. 182, No. 11, pgs. 3310- 3313; 2000) and in view of Kerr et al (WO 2020/186207 A2) has been maintained in view of Applicant' s amendments to the claims 196, 197, 201-205 and 208 as well as Applicant’s cancellation of claims 199 and 200 and has been re-written to address the new claim limitations filed on 04/06/2026.
Applicant's arguments filed 04/06/2026 have been fully considered but they are not persuasive. Applicant’s arguments are not found persuasive because Applicant argues claim 139 is amended to recite the Rep protein can be either B19 or HBoV1 as was a previous limitation of claim 211 which is now cancelled and therefore, the current rejection does not render the new limitations obvious.
Bieniossek, Kerr and Wang teach a single bacmid system comprising all the new limitations of the claims as recited above in the 35 U.S.C. 103 rejection of claim 139.
The previous rejection of claims 199 and 211 under 35 U.S.C. 103 over Bieniossek et al (Current Protocols in Protein Science, 51: 5.20.1-5.20.26; 2008) in view of Kerr et al (WO 2020/186207 A2; International Filing Date: 03/13/2020), as applied to claims 139, 196, 197, 200-205 and 208, in further view of Smith et al (Journal of Virology, Vol.73, No.4; April 1999, pg 2930-2937) has been withdrawn in view of Applicant’s cancellation of the claims filed on 04/06/2026.
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 139, 151 and 152 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 70 of copending Application No. 19/438,369 (referred to as ‘369 herein).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 70 of application ‘369 recites “a recombinant bacmid comprising: a sequence encoding an HBoV1 Rep, wherein the inserted HBoV1 Rep sequence disrupts the reading frame of a reporter gene or functional portion thereof; and a heterologous sequence comprising a nucleic acid molecule comprising the nucleotide sequence of SEQ ID NO: 3, 9, 14, 33 or 35” while claim 139 of the instant application recites “a recombinant bacmid comprising: a nucleotide sequence encoding a Rep protein, wherein the Rep sequence is derived from a B19 or HBoV1 parvovirus, and wherein the Rep sequence disrupts the reading frame of a reporter gene; and a heterologous nucleotide sequence comprising, from 5’ to 3’: a wild-type or truncated 5’inverted terminal repeat (5’ITR) derived from a first genome of a member of the viral family Parvoviridae; a nucleotide sequence encoding a protein; one or more expression control sequences operably linked to the nucleotide sequence encoding a protein; and a wild-type or truncated 3’ inverted terminal repeat (3’ ITR) derived from a second genome of a member of the viral family Parvoviridae”; claim 151 of the instant application recites “the recombinant bacmid of claim 139, wherein the heterologous nucleotide sequence comprises the nucleotide sequence of SEQ ID NO: 20 or SEQ ID NO: 29” in which instant SEQ ID NO: 20 has been found to be 100% identical to SEQ ID NO: 9 of application ‘369 (See Appendix I); and claim 152 of the instant application recites “the recombinant bacmid of claim 139, wherein the heterologous nucleotide sequence comprises the nucleotide sequence of SEQ ID NO: 19” which instant SEQ ID NO: 19 has been found to be 100% identical to SEQ ID NO: 14 of application ‘369 (See Appendix II). Therefore, the limitations of claim 70 of application ‘369 are found to anticipate the limitations of claim 139, 151 and 152 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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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/ALEXANDRA ROSE LIPPOLIS/Examiner, Art Unit 1637
/CELINE X QIAN/Primary Examiner, Art Unit 1637
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