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 .
Election/Restrictions
Claims 24 and 38-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions (Groups 2 and 3) and a non-elected species (claim 24- ITR regions), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/25/2025.
Applicant’s election without traverse of Group 1 (a capsid-free closed-ended DNA (ceDNA) vector), SEQ ID NO: 405 (ceDNA vector sequence), SEQ ID NO: 230 (promoter sequence), SEQ ID NO: 303 (enhancer sequence), SEQ ID NO: 320 (5’ UTR sequence), SEQ ID NO: 345 (3’ UTR sequence), SEQ ID NO: 360 (polyA sequence), AAV2/AAV2 (pair of viral serotypes), SEQ ID NOs: 32 and 15 (first and second ITR sequences), and D (ITR region) in the reply filed on 11/25/2025 is acknowledged.
In light of the cited prior art below, the intron region species “A, A’, B, B’, C, and C’” have been rejoined. Therefore, claim 24 is also rejoined.
Additionally, elected ceDNA vector sequence SEQ ID NO: 405 was found to be free of the art. Therefore, non-elected ceDNA vector sequence species SEQ ID NO: 404 and SEQ ID NO: 406 are rejoined.
The examiner notes that the elected ceDNA vector sequence (SEQ ID NO: 405) does not comprise the same elements as the species elected in claim 3 (e.g., SEQ ID NOs: 32 and 15 are not found in SEQ ID NO: 405; SEQ ID NO: 405 comprises different ITR sequences).
Claims 1-3, 9-12, 15, 19, 21, 23, 24, 31-33, 35-45, 47, 48, 52, 58, 60, and 62 are pending.
Claims 38-48 are withdrawn.
Claims 1-3, 9-12, 15, 19, 21, 23, 24, 31-33, 35-37, 52, 58, 60, and 62 are under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application PCT/US2021/023891, filed 03/24/2021, which claims the benefit of a prior-filed provisional application 62/993,857, filed 03/24/2020, under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/04/2022 and 04/02/2025 are considered by the examiner.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claims 12, 15, and 52 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 1 recites “A capsid-free closed-ended DNA (ceDNA) vector comprising: at least one nucleic acid sequence positioned between flanking inverted terminal repeats (ITRs), wherein the at least one nucleic acid sequence encodes at least one Factor IX (FIX} protein”.
Claim 12 recites “wherein the flanking ITRs are symmetric with respect to each other; the flanking ITRs are substantially symmetric with respect to each other; or the flanking ITRs are asymmetric with respect to each other”. However, the ITRs in independent claim 1 are either symmetric or not. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Claim 15 recites “wherein one of the flanking ITRs is a wild-type ITR, or wherein both of the flanking ITRs are wild-type ITRs” and/or “one of the flanking ITRs is not a wild-type ITR, or wherein both of the flanking ITRs are not wild- type ITRs”. However, the ITRs in independent claim 1 are either wild-type or not. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Claim 52 recites “A pharmaceutical composition comprising the ceDNA vector of claim 1”. The structure of the ceDNA of claim 52 is the same as in base claim 1. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 3, 10, 15, 32, and 35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With regard to claim 2, this claim is indefinite because it makes reference to Tables 1 and 12 for the nucleic acid sequences that encode the FIX protein.
MPEP 2173.05(s) states: “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)(citations omitted).”
In the instant case, the nucleic acid sequences can be easily incorporated into the claim.
In kind, claims 3, 15, 32, and 35 are similarly rejected.
Claim 10 recites “wherein the at least one flanking ITR comprises a functional terminal resolution site and a replication (Rep) binding site”. Base claim 1 comprises two ITRs, not one. Therefore, there is a lack of antecedent basis, and it is unclear to which ITR the claim is referring to. It would be remedial to recite “one or both” instead of “the at least one”. For examination purposes, one or both of the ITRs may comprise a functional terminal resolution site and a Rep binding site in claim 10.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3, 9-12, 15, 19, 21, 23, 24, 33, 52, 58, 60, and 62 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kotin (US20190032083A1, published 01/31/2019).
Regarding claim 1, Kotin discloses a capsid-free ceDNA vector comprising a nucleic acid encoding FIX positioned between flanking ITRs [0201, 0095].
Regarding claim 3, Kotin discloses the ceDNA vector comprising at least one promoter sequence linked to the nucleic acid sequence [0127].
Regarding claim 9, Kotin discloses the nucleic acid sequence being cDNA (i.e., (i) amplified in vitro by, for example, polymerase chain reaction (PCR); (ii) recombinantly produced by molecular cloning; (iii) purified, as by restriction endonuclease cleavage and gel electrophoretic fractionation, or column chromatography; or (iv) synthesized by, for example, chemical synthesis) [0055].
Regarding claim 10, Kotin discloses at least one ITR comprising a functional trs and replication binding site [0045].
Regarding claim 11, Kotin discloses the ITRs being derived from AAV [0045, 0201].
Regarding claim 12, Kotin discloses the ITRs being asymmetric [0201].
Regarding claim 15, Kotin discloses one or both of the ITRs being wild-type, not a wild-type, and/or derived from AAV2 [0077, 0201].
Regarding claim 19, Kotin discloses at least one of the ITRs being altered from the wild-type by a mutation (i.e., defective) that affects the overall 3D conformation of the ITR [0201].
Regarding claim 21, Kotin discloses one or both of the flanking ITRs being synthetic (i.e., made by chemical synthesis) [0055].
Regarding claims 23 and 24, Kotin discloses one or both of the ITRs having mutations (e.g., deletions) in the B, B’, C, and/or C’ regions [0067].
Regarding claim 33, Kotin discloses the ceDNA vector comprising at least one regulatory switch [0129, 0133].
Regarding claim 52, Kotin discloses a pharmaceutical composition comprising the ceDNA vector [0154].
Regarding claim 58, Kotin discloses a cell containing the ceDNA vector [0023].
Regarding claim 60, Kotin discloses a composition comprising the ceDNA vector and a lipid nanoparticle [0170].
Regarding claim 62, as discussed above, the inclusion of the ceDNA vector in a kit with instructions does not modify the structure of the claimed composition. Thus, claim 62 is rejected by the disclosure of Kotin (see claim 1 rejection above).
Claim(s) 1, 3, 9, 11, 12, 15, 19, 21, 23, 24, 31, 33, 52, 58, 60, and 62 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Samulski (WO2019246544A2, published 12/26/2019; foreign patent document #5 cite in IDS filed 11/04/2022).
Regarding claim 1, Samulski discloses a capsid-free ceDNA vector comprising a nucleic acid encoding FIX positioned between flanking ITRs [00259] (Example 6, starting [00342]).
Claim 2
Regarding claim 3, Samulski discloses the ceDNA vector comprising at least one promoter sequence (e.g., alpha1-antitrypsin promoter) linked to the nucleic acid sequence [0003, 00342].
Regarding claim 9, Samulski discloses the nucleic acid sequence being cDNA (i.e., the DNA template may be produced by the polymerase chain reaction (PCR)) [00135].
Regarding claim 11, Samulski discloses the ITRs being derived from parvovirus or AAV [0006, 0007].
Regarding claim 12, Samulski discloses the ITRs being completely symmetrical or partially symmetrical [00125].
Regarding claim 15, Samulski discloses one or both of the ITRs being wild-type, not a wild-type, or derived from AAV2 [0006-0007, 0065].
Regarding claim 19, Samulski discloses at least one of the ITRs being altered from the wild-type by a mutation that affects the overall 3D conformation of the ITR [0064].
Regarding claim 21, Samulski discloses one or both of the flanking ITRs being synthetic (i.e., made by chemical synthesis) [0006-0007, 0065].
Regarding claims 23 and 24, Samulski discloses one or both of the ITRs having mutations (e.g., deletions) in the A, A’, D. and D’ regions (claim 12, 27 of Samulski).
Regarding claim 31, Samulski discloses the ITRs being altered in a manner that results in an overall 3D symmetry when the ITRs are inverted relative to each other (e.g., complementary palindromic sequences) [0005]
Regarding claim 33, Samulski discloses the ceDNA vector comprising at least one regulatory switch [00193].
Regarding claim 52, Samulski discloses a pharmaceutical composition comprising the ceDNA vector [00204].
Regarding claim 58, Samulski discloses a cell containing the ceDNA vector [00198].
Regarding claim 60, Samulski discloses a composition comprising the ceDNA vector and a lipid nanoparticle [00239].
Regarding claim 62, as discussed above, the inclusion of the ceDNA vector in a kit with instructions does not modify the structure of the claimed composition. Thus, claim 62 is rejected by the disclosure of Samulski (see claim 1 rejection above).
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 1, 3, and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 63 and 142 of copending Application No. 17/617,330 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application anticipate the claims of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1: the reference claim 63 is drawn to a method of producing the ceDNA vectors that are presently claimed, except for the aspect of comprising a Factor IX (FIX) coding sequence. However, FIX is noted to be in reference claim 142.
Claim 3: the reference claim 63 is drawn to a method of producing the ceDNA vectors that are presently claimed, the method comprising a DNA construct comprising an expression cassette, which comprises a promoter linked to a transgene (e.g., FIX) (as noted above, FIX is referenced in reference claim 142). An embodiment of claim 3 requires the ceDNA vector to comprise at least one promoter sequence linked to the at least one nucleic acid sequence (e.g., encoding FIX).
Claim 11: the examiner notes that reference claim 156, dependent upon base claim 63, recites that said first ITR is a wild-type AAV ITR; said first ITR is mutant or modified AAV ITR; said second ITR is a wild-type AAV ITR; said second ITR is a mutant or modified AAV; at least one of the first ITR and the second ITR is an AAV ITR. However, this method does not include FIX (i.e., the limitations of reference claims 142 and 156 are not required to be present together as the reference claims are currently written).
Claim 12: the examiner notes that reference claim 146, dependent upon base claim 63, recites that the first ITR and said second ITR are symmetric or substantially symmetric with respect to each other; or said first ITR and said second ITR are asymmetric with respect to each other. However, this method does not include FIX (i.e., the limitations of reference claims 142 and 146 are not required to be present together as the reference claims are currently written).
Claim 15: the examiner notes that reference claim 156, dependent upon base claim 63, recites that said first ITR is a wild-type AAV ITR; said first ITR is mutant or modified AAV ITR; said second ITR is a wild-type AAV ITR; said second ITR is a mutant or modified AAV; at least one of the first ITR and the second ITR is an AAV ITR. Some embodiments of claim 15 require one or both ITRs to be wild-type, or one or both ITRs to not be wildtype (e.g., mutant/modified). However, this method does not include FIX (i.e., the limitations of reference claims 142 and 156 are not required to be present together as the reference claims are currently written).
Claim 19: the examiner notes that reference claim 156, dependent upon base claim 63, recites that said first ITR is a wild-type AAV ITR; said first ITR is mutant or modified AAV ITR; said second ITR is a wild-type AAV ITR; said second ITR is a mutant or modified AAV; at least one of the first ITR and the second ITR is an AAV ITR; and/or at least one of the first ITR and the second ITR is an artificial sequence that forms a closed-ended stem-loop structure (e.g., affects overall three-dimensional conformation of the ITR). Some embodiments of claim 15 require one or both ITRs to be wild-type, or one or both ITRs to not be wildtype (e.g., mutant/modified). However, this method does not include FIX (i.e., the limitations of reference claims 142 and 156 are not required to be present together as the reference claims are currently written).
Claim 52: the reference claim 63 is drawn to a method of producing the ceDNA vectors that are presently claimed, except for the aspect of comprising a Factor IX (FIX) coding sequence. However, FIX is noted to be in reference claim 142.
Claims 2, 9, 10, 20, 23, 31, 32, 33, 35, 36, 37, 58, 60, and 62: N/A
The invention is obvious over the reference, as the reference claims methods of making the composition claimed. One of ordinary skill in the art would do so and expect success, as it is claimed subject matter.
Claims 1, 3, 11, and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of copending Application No. 17/617,332 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application anticipate the claims of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. However, the examiner notes that a Notice of Allowance was filed 12/04/2025, and a payment was made 01/27/2026. The patent has yet to be published. Therefore, this rejection cannot be withdrawn (as the patent is expect to go through, and would no longer be considered provisional nonstatutory double patenting).
Claim 1: the reference claim 1 is drawn to a method of producing the ceDNA vectors (e.g., single-stranded AAV vector using a ceDNA vector) that are presently claimed, except for the aspect of comprising a Factor IX (FIX) coding sequence. However, FIX is noted to be in reference claim 3.
Claim 3: the reference claim 1 is drawn to a method of producing the ceDNA vectors (e.g., single-stranded AAV vector using a ceDNA vector) that are presently claimed, the method comprising a DNA construct comprising an expression cassette, which comprises a promoter linked to a transgene (e.g., FIX) (as noted above, FIX is referenced in reference claim 1). An embodiment of claim 3 requires the ceDNA vector to comprise at least one promoter sequence linked to the at least one nucleic acid sequence (e.g., encoding FIX).
Claim 11: the method of reference claim 1 creates a single-stranded AAV vector by removing one strand from the gapped ceDNA vector by contacting the gapped ceDNA vector with a strand specific exonuclease. As such, an artisan would reasonably conclude that one or both of the flanking ITRs are derived from AAV. As noted above, FIX is recited in reference claim 3, which depends upon reference claim 1.
Claim 52: the reference claim 1 is drawn to a method of producing the ceDNA vectors (e.g., single-stranded AAV vector using a ceDNA vector) that are presently claimed, except for the aspect of comprising a Factor IX (FIX) coding sequence. However, FIX is noted to be in reference claim 3.
Claims 2, 9, 10, 12, 15, 19, 21, 23, 31, 32, 33, 35, 36, 37, 58, 60, and 62: N/A
The invention is obvious over the reference, as the reference claims methods of making the composition claimed. One of ordinary skill in the art would do so and expect success, as it is claimed subject matter.
Claims 1, 3, 10-12, 15, 19, 21, 23, 33, 52, 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 22, 21, 24, 32, 54, 36, 18, and 6 of copending Application No. 16/971,016 in view of Herzog (Herzog, Roland W., et al. "Stable gene transfer and expression of human blood coagulation factor IX after intramuscular injection of recombinant adeno-associated virus." Proceedings of the National Academy of Sciences 94.11 (1997): 5804-5809.).
Claim 1: the reference claim 4 is drawn to a method of using the ceDNA vectors that are presently claimed, except for the aspect of comprising a Factor IX (FIX) coding sequence. The claims of the reference application do not refer to FIX. However, the claimed method is generic to expressing a transgene using a ceDNA vector comprising a nucleic acid cassette containing at least one transgene linking to a promoter between flanking ITRs.
Herzog teaches an rAAV vector expressing human FIX to direct the expression of therapeutic levels of the transgene in experimental animals, specifically mice (Abstract). The rAAV vector contained the hFIX cDNA under control of the CMV immediate early gene promoter/enhancer and polyA, and the expression cassette was flanked by ITRs (pg. 5805, col 2, “Expression of hFIX in Immunocompetent Mice”). Blood samples were collected from injected mice at 7-day intervals for analysis (pg. 5805, col 1, “Animal Experiments”). When injection of AAV-F.IX was carried out in immunodeficient (Rag 1) mice, all animals achieved therapeutic levels of hFIX, in the range of 200–350 ng/ml. These levels, which represent 4–7% of normal circulating levels in plasma, are well within a therapeutic range, and demonstrate that the approach is a feasible one from the standpoint of treating hemophilia (pg. 5807, col 2, para 1).
It would have been obvious to an artisan to use the method of regulating expression of a transgene in a subject (i.e., method of use) recited in the reference application to express FIX by having the ceDNA vector comprise a nucleic acid cassette containing FIX linked to a promoter between flanking ITRs (i.e., the claimed ceDNA vector). One of ordinary skill expect success because Herzog demonstrates successfully expressing FIX in the blood of a mouse, and the claims of the reference application are generic to any transgene. Additionally, reference claim 44 recites using the method of claim 4 to treat a subject with hemophilia, which is a disease associated with FIX.
The teachings of Herzog apply to all dependent claims below.
Claim 3: the reference claim 4 recites the ceDNA vector comprising a nucleic acid cassette containing a transgene (e.g., FIX, as taught above) linked to a promoter between flanking ITRs. An embodiment of claim 3 requires the ceDNA vector to comprise at least one promoter sequence linked to the at least one nucleic acid sequence.
Claim 10: the reference claim 22, which depends upon claim 4, recites at least one of the flanking ITRs comprising a functional terminal resolution site and a Rep binding site.
Claim 11: the reference claim 21, which depends upon claim 4, recite one or both of the ITRs being derived from AAV.
Claim 12: the reference claim 24, which depends upon claim 4, recite embodiments (e.g., “and/or”) where the flanking ITRs are symmetric or asymmetric; the flanking ITRs are symmetric or substantially symmetric; or the flanking ITRs are asymmetric.
Claim 15: the reference claim 32, which depends upon claim 4, recite embodiments (e.g., “and/or”) where one of the flanking ITRs is not a wild type ITR; both of the flanking ITRs are not wild-type ITRs; one of the flanking ITRs is a wild type ITR; or both of the flanking ITRs are wild-type ITRs.
Claim 19: the reference claim 36, which depends upon claim 4, recite embodiments (e.g., “and/or”) where one or both of the flanking ITRs are modified by a deletion, an insertion, and/or a substitution in at least one of the ITR regions that results in the deletion of all or part of a stem-loop structure formed by the B and B' ITR region and/or all or part of a stem-loop structure formed by the C and C' ITR region (e.g., affects the overall three-dimensional conformation of the ITR).
Claim 21: the reference claim 54, which depends upon claim 4, recites one or both of the flanking ITRs being synthetic.
Claim 23: the reference claim 36, which depends upon claim 4, recite embodiments (e.g., “and/or”) where one or both of the flanking ITRs are modified by a deletion, an insertion, and/or a substitution in at least one of the ITR regions selected from an A, A', B, B', C, C', D, and D' region.
Claim 33: the reference claim 18, which depends upon claim 4, recites the capsid-free ceDNA vector further comprising a regulatory switch.
Claim 52: the reference claim 6, which depends upon claim 4, recites administering a pharmaceutically acceptable carrier in combination with the capsid-free ceDNA vector (i.e., a pharmaceutical composition) (i.e., a method of use of the claimed invention). See discussion for instant claim 1 above regarding FIX.
Claim 58: the reference claim 4, a method of use of the claimed composition (see discussion for instant claim 1 above regarding FIX), recites administering the ceDNA vector to a subject to express a transgene. This would result in a cell containing the ceDNA vector.
Claims 9, 31, 32, 35, 36, 37, and 62: N/A
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
SEQ ID NOs: 32, 15, 404, 405, and 406 were found to be free of the art.
High (US20160375110A1, published 12/29/2016) teaches an AAV vector comprising a nucleic acid sequence sharing 94.6% identity with instant SEQ ID NO: 404 (SEQ ID NO: 12 of High). However, High does not teach a ceDNA vector comprising the nucleic acid sequence sharing 94.6% identity with instant SEQ ID NO: 404.
Other than High, the closest match in the priority art shared about 60% identity with SEQ ID NOs: 404, 405, or 406.
As such, claims 36 and 37 are allowable over the prior art.
Conclusion
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ALLISON M. JOHNSON
Examiner
Art Unit 1638
/ALLISON MARIE JOHNSON/Examiner, Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638