DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s response to restriction requirement filed on January 23, 2026 have been received and entered. Claims 1-24 are pending in the instant application.
Election/Restrictions
Applicant's election with traverse of claims 1-9, 16-19, 22-24 (group I) in the reply filed on January 23, 2026 is acknowledged. The traversal is on the ground that claims 16-19, 22-24 should be re-grouped with the invention of group IV. This is found persuasive and therefore claims 16-19, 22-24 are hereby rejoined with invention of group IV (claims 20-21). Upon further consideration election of species requirement between different muscle specific promoter is hereby withdrawn. The requirement is still deemed proper and is therefore made FINAL.
Claims 10--24 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 23, 2026.
Priority
This application is a Continuation of application no 18/906,008 filed on 10/03/2024, which is a Continuation of application no 17/837,821 filed on 06/10/2022, which is continuation of application no 16/093,022 filed on 10/11/2018 , which is a 371 of PCT/US2017/027636 filed on 04/14/2017 that claims priority from US provisional application no 62/473,253 filed on which claims priority from US provisional application no 62/323,163 filed on 04/15/2016.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/23/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claims 1-9 are under consideration.
Claim Rejections - 35 USC § 112
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 1-9 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.
Claim 1 is indefinite to the extent the metes and bounds of the term “a-micro-dystrophin 1 gene could not be ascertained. There is no naturally occurring micro-dystrophin 1 gene. The gene that encodes the dystrophin protein (DMD) is unusually large, spanning ~2.2 Mb at Xp21. It consists of consists of 79 exons, with ~99% of the gene being intronic sequence (see Chwalenia et al Gene Therapy (2025) 32:447–46 cited as evidence without relying on the rejection). The term micro-dystrophin inherently implies that it is a laboratory constructed truncated coding sequence of the dystrophin gene or a cDNA. Recitation of a cDNA encoding the micro-dystrophin protein consisting of the amino acid sequence set forth in SEQ ID NO: 8 would obviate the basis of the rejection. Claims 2-9 are included in the rejection because they directly or indirectly depend from the rejected base claim. Appropriate correction and/or clarification is required.
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 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No 11723986. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are directed to a recombinant adeno-associated virus (rAAV) vector comprising a-coding sequence of micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO. For instance, instant claims are directed to a recombinant adeno-associated virus (rAAV) vector comprising a-micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO: 8. Dependent claims limit the rAAV vector of claim 1, wherein the rAAV vector has an AAV serotype selected from AAV-1, AAV-2, AAV-3, AAV-4, AAV-5, AAV-6, AAV-7, AAV-8, AAV-9, AAV-10, AAV-11, AAV-12, AAV-13, or AAV rh.74, or a variant of each thereof subsequently limiting to an AAV serotype is of serotype AAVrh.74, or a variant thereof. Claims 5-7 are directed to the rAAV vector of claim 1, wherein the nucleotide sequence further comprises in the 5' to 3' direction an inverted terminal repeat (ITR), a muscle-specific control element, a chimeric intron sequence, the micro-dystrophin gene, a poly A tail, and an ITR, wherein the muscle-specific control element comprises the nucleotide sequence set forth in SEQ ID NO: 10 or SEQ ID NO: 11, , wherein the chimeric intron sequence comprises nucleotides 844-993 of SEQ ID NO:9 and wherein the poly A tail comprises nucleotides 4585 to 4640 of SEQ ID NO:9. Claim 9 is drawn to a composition comprising the rAAV vector of claim 1, and a pharmaceutically acceptable carrier. In contrast, claims in ‘986 are directed to Aa recombinant AAVrh74 vector comprising in the 5′ to 3′ direction (i) a 5′ AAV inverted terminal repeat (ITR) sequence, (ii) a muscle-specific control element, (iii) a chimeric intron sequence consisting of the nucleotides 844-993 of SEQ ID NO:9, (iv) the nucleotide sequence as set forth in SEQ ID NO: 7, (v) a poly A tail that has the sequence as set forth in nucleotide 4585 to 4640 of SEQ ID NO:9, and (vi) a 3′AAV ITR sequence. Dependent claims limit the AAVrh74 vector of claim 1, wherein the muscle-specific control element is selected from the group consisting of the nucleotide sequence as set forth in SEQ ID NO: 10 and SEQ ID NO: 11. Claims 3 is directed to a composition comprising the recombinant AAVrh74 vector of claim 1 and a pharmaceutically acceptable carrier.
As such, the ‘986 claims represent a species as set forth in SEQ ID NO 7 of the instant broader claims to a-micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO: 8. In the instant case, claims 7 encodes the amino acid sequence of SEQ ID NO: 8 (see sequence search results). It is well established that a species of a claimed invention renders the genus obvious. In re Schaumann, 572 F.2d 312, 197 USPQ 5 (CCPA 1978). Therefrom, a recombinant adeno-associated virus (rAAV) vector claimed in ‘986 encompass the recombinant AAV of the instant application.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No 11406717. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are directed to a recombinant adeno-associated virus (rAAV) vector comprising a-coding sequence of micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO. For instance, instant claims are directed to a recombinant adeno-associated virus (rAAV) vector comprising a-micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO: 8. Dependent claims limit the rAAV vector of claim 1, wherein the rAAV vector has an AAV serotype selected from AAV-1, AAV-2, AAV-3, AAV-4, AAV-5, AAV-6, AAV-7, AAV-8, AAV-9, AAV-10, AAV-11, AAV-12, AAV-13, or AAV rh.74, or a variant of each thereof subsequently limiting to an AAV serotype is of serotype AAVrh.74, or a variant thereof. Claims 5-7 are directed to the rAAV vector of claim 1, wherein the nucleotide sequence further comprises in the 5' to 3' direction an inverted terminal repeat (ITR), a muscle-specific control element, a chimeric intron sequence, the micro-dystrophin gene, a poly A tail, and an ITR, wherein the muscle-specific control element comprises the nucleotide sequence set forth in SEQ ID NO: 10 or SEQ ID NO: 11, , wherein the chimeric intron sequence comprises nucleotides 844-993 of SEQ ID NO:9 and wherein the poly A tail comprises nucleotides 4585 to 4640 of SEQ ID NO:9. Claim 9 is drawn to a composition comprising the rAAV vector of claim 1, and a pharmaceutically acceptable carrier. In contrast, claims in 717are directed to use of a recombinant AAVrh74 vector comprising expressing micro-dystrophin comprises a) a nucleotide sequence having at least 85% identity to the nucleotide sequence SEQ ID NO: 7 and encodes a functional micro-dystrophin protein, wherein the nucleotide sequence encoding a functional micro-dystrophin is operably linked to a muscle-specific control element or an ubiquitous subsequently limiting the muscle-specific control element comprises the nucleotides 236 to 799 of SEQ ID NO: 9. As such, the ‘717 claims represent a species of nucleotide sequence as set forth in SEQ ID NO 7 of the instant broader claims to a-micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO: 8. In the instant case, the coding sequence of micro dystrophin of SEQ ID NO: 7 encodes the amino acid sequence of SEQ ID NO: 8 (see sequence search results). It is well established that a species of a claimed invention renders the genus obvious. In re Schaumann, 572 F.2d 312, 197 USPQ 5 (CCPA 1978). Therefrom, a recombinant adeno-associated virus (rAAV) claimed in the instant application is encompassed by the recombinant AAV of the 11406717.
Claims 1-4, 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No 12491265. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are directed to a recombinant adeno-associated virus (rAAV) vector comprising a-coding sequence of micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO. For instance, instant claims are directed to a recombinant adeno-associated virus (rAAV) vector comprising a-micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO: 8. Dependent claims limit the rAAV vector of claim 1, wherein the rAAV vector has an AAV serotype selected from AAV-1, AAV-2, AAV-3, AAV-4, AAV-5, AAV-6, AAV-7, AAV-8, AAV-9, AAV-10, AAV-11, AAV-12, AAV-13, or AAV rh.74, or a variant of each thereof subsequently limiting to an AAV serotype is of serotype AAVrh.74, or a variant thereof. Claim 9 is drawn to a composition comprising the rAAV vector of claim 1, and a pharmaceutically acceptable carrier. In contrast, claims in ‘265 are directed to use of a recombinant adeno-virus associated (rAAV) serotype rh.74 comprising a polynucleotide comprising the nucleotide sequence of SEQ ID NO: 1 operably linked to a promoter sequence . As such, the ‘265 claims represent a species of nucleotide sequence as set forth in SEQ ID NO 1 of the instant broader claims to a-micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO: 8. In the instant case, the coding sequence of micro dystrophin of SEQ ID NO: 1 encodes the amino acid sequence of SEQ ID NO: 8 (see sequence search results). It is well established that a species of a claimed invention renders the genus obvious. In re Schaumann, 572 F.2d 312, 197 USPQ 5 (CCPA 1978). Therefrom, a recombinant adeno-associated virus (rAAV) claimed in the instant application is encompassed by the recombinant AAV of the 12491265.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 14 of copending Application No 17832325. although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are directed to a recombinant adeno-associated virus (rAAV) vector comprising a-coding sequence of micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO. For instance, instant claims are directed to a recombinant adeno-associated virus (rAAV) vector comprising a-micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO: 8. Dependent claims limit the rAAV vector of claim 1, wherein the rAAV vector has an AAV serotype selected from AAV-1, AAV-2, AAV-3, AAV-4, AAV-5, AAV-6, AAV-7, AAV-8, AAV-9, AAV-10, AAV-11, AAV-12, AAV-13, or AAV rh.74, or a variant of each thereof subsequently limiting to an AAV serotype is of serotype AAVrh.74, or a variant thereof. Claims 5-7 are directed to the rAAV vector of claim 1, wherein the nucleotide sequence further comprises in the 5' to 3' direction an inverted terminal repeat (ITR), a muscle-specific control element, a chimeric intron sequence, the micro-dystrophin gene, a poly A tail, and an ITR, wherein the muscle-specific control element comprises the nucleotide sequence set forth in SEQ ID NO: 10 or SEQ ID NO: 11, , wherein the chimeric intron sequence comprises nucleotides 844-993 of SEQ ID NO:9 and wherein the poly A tail comprises nucleotides 4585 to 4640 of SEQ ID NO:9. Claim 9 is drawn to a composition comprising the rAAV vector of claim 1, and a pharmaceutically acceptable carrier. In contrast, claims in ‘325 are directed to recombinant AAVrh.74 vector comprising a MHCK7 muscle specific promoter/enhancer operably linked to the nucleotide sequence of SEQ ID NO: 1, wherein the recombinant AAVrh.74 vector comprises a 5' AAV2 inverted terminal repeat (ITR), the MHCK7 muscle-specific promoter/enhancer, an SV40 intron, the nucleotide sequence of SEQ ID NO: 1, a synthetic polyadenylation (PolyA) signal and a 3'AAV2 ITR. Claims 3 is directed to a composition comprising the recombinant AAVrh74 vector of claim 1 and a pharmaceutically acceptable carrier. As such, the ‘325 claims represent a nucleotide species set forth in SEQ ID NO 7 of the instant broader claims to a-micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO: 8. In the instant case, claims 7 encodes the amino acid sequence of SEQ ID NO: 8 (see sequence search results). It is well established that a species of a claimed invention renders the genus obvious. In re Schaumann, 572 F.2d 312, 197 USPQ 5 (CCPA 1978). Therefrom, a recombinant adeno-associated virus (rAAV) vector of instant application encompasses the recombinant AAV of ‘325. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 67-59, 75 and 77 of copending Application No 18876051. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are directed to a recombinant adeno-associated virus (rAAV) vector comprising a-coding sequence of micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO. For instance, instant claims are directed to a recombinant adeno-associated virus (rAAV) vector comprising a-micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO: 8. Dependent claims limit the rAAV vector of claim 1, wherein the rAAV vector has an AAV serotype selected from AAV-1, AAV-2, AAV-3, AAV-4, AAV-5, AAV-6, AAV-7, AAV-8, AAV-9, AAV-10, AAV-11, AAV-12, AAV-13, or AAV rh.74, or a variant of each thereof subsequently limiting to an AAV serotype is of serotype AAVrh.74, or a variant thereof. Claims 5-7 are directed to the rAAV vector of claim 1, wherein the nucleotide sequence further comprises in the 5' to 3' direction an inverted terminal repeat (ITR), a muscle-specific control element, a chimeric intron sequence, the micro-dystrophin gene, a poly A tail, and an ITR, wherein the muscle-specific control element comprises the nucleotide sequence set forth in SEQ ID NO: 10 or SEQ ID NO: 11, , wherein the chimeric intron sequence comprises nucleotides 844-993 of SEQ ID NO:9 and wherein the poly A tail comprises nucleotides 4585 to 4640 of SEQ ID NO:9. Claim 9 is drawn to a composition comprising the rAAV vector of claim 1, and a pharmaceutically acceptable carrier. In contrast, claims in ‘051 are directed to use a recombinant adeno-virus associated (rAAV) serotype rh.74 comprising a polynucleotide comprising the a genetic cassette encoding a therapeutic molecule that is myodystrophy comprising SEQ ID NO: 19 operably linked to a tissue specific promoter. It is relevant to note that SEQ ID NO: 8 of instant application is encoded by SEQ ID NO: 19 of ‘051 (see sequence search result).
Qy 1 MetLeuTrpTrpGluGluValGluAspCysTyrGluArgGluAspValGlnLysLysThr 20
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ATGCTGTGGTGGGAGGAGGTGGAGGATTGTTATGAAAGGGAGGACGTGCAGAAGAAGACT 60
Qy 21 PheThrLysTrpValAsnAlaGlnPheSerLysPheGlyLysGlnHisIleGluAsnLeu 40
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 TTTACCAAGTGGGTGAACGCTCAGTTCAGCAAATTTGGGAAGCAGCACATCGAGAATCTG 120
Qy 41 PheSerAspLeuGlnAspGlyArgArgLeuLeuAspLeuLeuGluGlyLeuThrGlyGln 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TTTTCCGACCTGCAGGATGGGAGACGGCTGCTGGATCTGCTGGAAGGACTGACTGGCCAG 180
Qy 61 LysLeuProLysGluLysGlySerThrArgValHisAlaLeuAsnAsnValAsnLysAla 80
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 AAGCTGCCCAAAGAGAAGGGGAGCACTAGGGTGCACGCCCTGAACAACGTGAACAAAGCT 240
Qy 81 LeuArgValLeuGlnAsnAsnAsnValAspLeuValAsnIleGlySerThrAspIleVal 100 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 CTGAGAGTGCTGCAGAACAACAACGTGGATCTGGTGAATATTGGCAGTACTGATATCGTG 300
Qy 101 AspGlyAsnHisLysLeuThrLeuGlyLeuIleTrpAsnIleIleLeuHisTrpGlnVal 120 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 GACGGGAACCACAAACTGACACTGGGCCTGATCTGGAACATTATTCTGCACTGGCAGGTG 360
Qy 121 LysAsnValMetLysAsnIleMetAlaGlyLeuGlnGlnThrAsnSerGluLysIleLeu 140 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 AAAAATGTGATGAAGAACATCATGGCCGGGCTGCAGCAGACCAATTCCGAGAAGATCCTG 420
Qy 141 LeuSerTrpValArgGlnSerThrArgAsnTyrProGlnValAsnValIleAsnPheThr 160 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 CTGTCTTGGGTGCGGCAGAGCACCCGCAACTATCCCCAGGTGAACGTGATTAACTTCACT 480
Qy 161 ThrSerTrpSerAspGlyLeuAlaLeuAsnAlaLeuIleHisSerHisArgProAspLeu 180 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 ACATCCTGGAGCGACGGGCTGGCCCTGAATGCTCTGATTCACAGCCACAGGCCTGATCTG 540
Qy 181 PheAspTrpAsnSerValValCysGlnGlnSerAlaThrGlnArgLeuGluHisAlaPhe 200 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 TTCGACTGGAATAGCGTGGTGTGCCAGCAGTCTGCCACACAGCGCCTGGAACATGCCTTC 600
Qy 201 AsnIleAlaArgTyrGlnLeuGlyIleGluLysLeuLeuAspProGluAspValAspThr 220 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 AATATCGCTCGGTACCAGCTGGGGATCGAAAAACTGCTGGACCCAGAGGATGTGGACACT 660
Qy 221 ThrTyrProAspLysLysSerIleLeuMetTyrIleThrSerLeuPheGlnValLeuPro 240 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 ACATACCCAGATAAAAAGTCTATTCTGATGTACATTACTAGCCTGTTCCAGGTGCTGCCA 720
Qy 241 GlnGlnValSerIleGluAlaIleGlnGluValGluMetLeuProArgProProLysVal 260 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 CAGCAGGTGTCTATTGAAGCCATTCAGGAGGTGGAAATGCTGCCCCGCCCCCCCAAAGTG 780
Qy 261 ThrLysGluGluHisPheGlnLeuHisHisGlnMetHisTyrSerGlnGlnIleThrVal 280 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 ACTAAAGAGGAGCATTTTCAGCTGCATCATCAGATGCATTACAGCCAGCAGATTACCGTG 840
Qy 281 SerLeuAlaGlnGlyTyrGluArgThrSerSerProLysProArgPheLysSerTyrAla 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 AGCCTGGCTCAGGGATATGAGCGCACCAGTAGTCCAAAACCACGGTTCAAGTCCTACGCT 900
Qy 301 TyrThrGlnAlaAlaTyrValThrThrSerAspProThrArgSerProPheProSerGln 320 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 TATACCCAGGCTGCCTACGTGACAACTAGCGACCCTACTAGATCCCCCTTTCCATCCCAG 960
Qy 321 HisLeuGluAlaProGluAspLysSerPheGlySerSerLeuMetGluSerGluValAsn 340 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 CACCTGGAGGCCCCAGAGGACAAGAGCTTTGGGTCCAGCCTGATGGAAAGCGAGGTGAAT 1020
Qy 341 LeuAspArgTyrGlnThrAlaLeuGluGluValLeuSerTrpLeuLeuSerAlaGluAsp 360 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 CTGGATCGGTACCAGACAGCCCTGGAGGAGGTGCTGAGCTGGCTGCTGAGTGCTGAAGAC 1080
Qy 361 ThrLeuGlnAlaGlnGlyGluIleSerAsnAspValGluValValLysAspGlnPheHis 380 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 ACACTGCAGGCCCAGGGCGAAATTTCCAATGACGTGGAAGTGGTGAAGGATCAGTTCCAC 1140
Qy 381 ThrHisGluGlyTyrMetMetAspLeuThrAlaHisGlnGlyArgValGlyAsnIleLeu 400 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1141 ACACACGAGGGCTATATGATGGACCTGACAGCTCACCAGGGGCGCGTGGGCAATATCCTG 1200
Qy 401 GlnLeuGlySerLysLeuIleGlyThrGlyLysLeuSerGluAspGluGluThrGluVal 420 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1201 CAGCTGGGCTCTAAACTGATCGGCACCGGGAAACTGAGTGAGGACGAGGAAACAGAAGTG 1260
Qy 421 GlnGluGlnMetAsnLeuLeuAsnSerArgTrpGluCysLeuArgValAlaSerMetGlu 440 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1261 CAGGAGCAGATGAACCTGCTGAACAGCCGCTGGGAGTGTCTGAGAGTGGCTAGTATGGAG 1320
Qy 441 LysGlnSerAsnLeuHisArgValLeuMetAspLeuGlnAsnGlnLysLeuLysGluLeu 460 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1321 AAGCAGTCCAACCTGCACCGGGTGCTGATGGACCTGCAGAACCAGAAACTGAAAGAGCTG 1380
Qy 461 AsnAspTrpLeuThrLysThrGluGluArgThrArgLysMetGluGluGluProLeuGly 480 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1381 AACGACTGGCTGACAAAGACTGAGGAACGCACAAGGAAGATGGAGGAGGAGCCACTGGGA 1440
Qy 481 ProAspLeuGluAspLeuLysArgGlnValGlnGlnHisLysValLeuGlnGluAspLeu 500 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1441 CCCGACCTGGAGGATCTGAAGAGACAGGTGCAGCAGCATAAGGTGCTGCAGGAGGATCTG 1500
Qy 501 GluGlnGluGlnValArgValAsnSerLeuThrHisMetValValValValAspGluSer 520 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1501 GAACAGGAGCAGGTGCGGGTGAACTCCCTGACACATATGGTGGTGGTGGTGGACGAATCT 1560
Qy 521 SerGlyAspHisAlaThrAlaAlaLeuGluGluGlnLeuLysValLeuGlyAspArgTrp 540 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1561 AGTGGAGATCACGCCACCGCCGCCCTGGAGGAACAGCTGAAGGTGCTGGGGGACCGGTGG 1620
Qy 541 AlaAsnIleCysArgTrpThrGluAspArgTrpValLeuLeuGlnAspIleLeuLeuLys 560 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1621 GCCAACATTTGCCGGTGGACCGAGGACAGGTGGGTGCTGCTGCAGGACATCCTGCTGAAA 1680
Qy 561 TrpGlnArgLeuThrGluGluGlnCysLeuPheSerAlaTrpLeuSerGluLysGluAsp 580 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1681 TGGCAGAGGCTGACCGAGGAGCAGTGTCTGTTTAGTGCTTGGCTGAGCGAGAAAGAGGAC 1740
Qy 581 AlaValAsnLysIleHisThrThrGlyPheLysAspGlnAsnGluMetLeuSerSerLeu 600 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1741 GCCGTGAACAAGATCCACACAACCGGCTTTAAGGATCAGAACGAAATGCTGTCTAGCCTG 1800
Qy 601 GlnLysLeuAlaValLeuLysAlaAspLeuGluLysLysLysGlnSerMetGlyLysLeu 620 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1801 CAGAAACTGGCTGTGCTGAAGGCCGATCTGGAGAAAAAGAAGCAGAGCATGGGCAAACTG 1860
Qy 621 TyrSerLeuLysGlnAspLeuLeuSerThrLeuLysAsnLysSerValThrGlnLysThr 640 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1861 TATAGCCTGAAACAGGACCTGCTGAGCACCCTGAAGAACAAGAGCGTGACCCAGAAGACA 1920
Qy 641 GluAlaTrpLeuAspAsnPheAlaArgCysTrpAspAsnLeuValGlnLysLeuGluLys 660 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1921 GAAGCCTGGCTGGATAACTTTGCCCGCTGCTGGGACAACCTGGTGCAGAAACTGGAGAAA 1980
Qy 661 SerThrAlaGlnIleSerGlnAlaValThrThrThrGlnProSerLeuThrGlnThrThr 680 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1981 AGTACAGCTCAGATCTCTCAGGCTGTGACCACAACCCAGCCTAGCCTGACCCAGACAACC 2040
Qy 681 ValMetGluThrValThrThrValThrThrArgGluGlnIleLeuValLysHisAlaGln 700 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2041 GTGATGGAAACCGTGACCACCGTGACAACCCGCGAACAGATCCTGGTGAAACATGCCCAG 2100
Qy 701 GluGluLeuProProProProProGlnLysLysArgThrLeuGluArgLeuGlnGluLeu 720 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2101 GAAGAGCTGCCACCTCCACCTCCCCAGAAGAAGAGAACCCTGGAGCGGCTGCAGGAGCTG 2160
Qy 721 GlnGluAlaThrAspGluLeuAspLeuLysLeuArgGlnAlaGluValIleLysGlySer 740 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2161 CAGGAAGCCACTGACGAACTGGACCTGAAGCTGAGGCAGGCCGAAGTGATTAAGGGGTCT 2220
Qy 741 TrpGlnProValGlyAspLeuLeuIleAspSerLeuGlnAspHisLeuGluLysValLys 760 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2221 TGGCAGCCTGTGGGCGATCTGCTGATTGATTCCCTGCAGGACCACCTGGAAAAGGTGAAG 2280
Qy 761 AlaLeuArgGlyGluIleAlaProLeuLysGluAsnValSerHisValAsnAspLeuAla 780 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2281 GCTCTGAGAGGCGAAATTGCTCCACTGAAGGAGAACGTGAGTCATGTGAACGATCTGGCT 2340
Qy 781 ArgGlnLeuThrThrLeuGlyIleGlnLeuSerProTyrAsnLeuSerThrLeuGluAsp 800 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2341 AGACAGCTGACAACACTGGGCATCCAGCTGAGCCCATACAATCTGAGCACACTGGAGGAC 2400
Qy 801 LeuAsnThrArgTrpLysLeuLeuGlnValAlaValGluAspArgValArgGlnLeuHis 820 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2401 CTGAATACCAGGTGGAAGCTGCTGCAGGTGGCTGTGGAAGACCGGGTGCGGCAGCTGCAT 2460
Qy 821 GluAlaHisArgAspPheGlyProAlaSerGlnHisPheLeuSerThrSerValGlnGly 840 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2461 GAGGCCCATCGCGACTTCGGACCAGCCAGCCAGCACTTTCTGAGCACATCCGTGCAGGGG 2520
Qy 841 ProTrpGluArgAlaIleSerProAsnLysValProTyrTyrIleAsnHisGluThrGln 860 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2521 CCCTGGGAGAGGGCCATTTCTCCCAACAAGGTGCCCTACTATATTAATCACGAGACCCAG 2580
Qy 861 ThrThrCysTrpAspHisProLysMetThrGluLeuTyrGlnSerLeuAlaAspLeuAsn 880 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2581 ACCACTTGTTGGGACCATCCCAAGATGACAGAACTGTACCAGTCCCTGGCCGATCTGAAC 2640
Qy 881 AsnValArgPheSerAlaTyrArgThrAlaMetLysLeuArgArgLeuGlnLysAlaLeu 900 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2641 AACGTGAGGTTTAGCGCTTACAGAACCGCTATGAAGCTGAGACGGCTGCAGAAGGCCCTG 2700
Qy 901 CysLeuAspLeuLeuSerLeuSerAlaAlaCysAspAlaLeuAspGlnHisAsnLeuLys 920 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2701 TGCCTGGATCTGCTGTCCCTGTCCGCCGCCTGCGATGCCCTGGATCAGCATAATCTGAAG 2760
Qy 921 GlnAsnAspGlnProMetAspIleLeuGlnIleIleAsnCysLeuThrThrIleTyrAsp 940 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2761 CAGAACGATCAGCCAATGGATATCCTGCAGATCATCAACTGCCTGACCACTATCTACGAC 2820
Qy 941 ArgLeuGluGlnGluHisAsnAsnLeuValAsnValProLeuCysValAspMetCysLeu 960 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2821 AGGCTGGAGCAGGAGCACAACAACCTGGTGAACGTGCCTCTGTGCGTGGATATGTGCCTG 2880
Qy 961 AsnTrpLeuLeuAsnValTyrAspThrGlyArgThrGlyArgIleArgValLeuSerPhe 980 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2881 AACTGGCTGCTGAACGTGTATGACACTGGGCGCACCGGCCGGATCAGAGTGCTGAGTTTT 2940
Qy 981 LysThrGlyIleIleSerLeuCysLysAlaHisLeuGluAspLysTyrArgTyrLeuPhe 1000 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2941 AAAACTGGGATTATCTCCCTGTGTAAGGCCCACCTGGAGGACAAGTACAGGTACCTGTTC 3000
Qy 1001 LysGlnValAlaSerSerThrGlyPheCysAspGlnArgArgLeuGlyLeuLeuLeuHis 1020 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3001 AAGCAGGTGGCTAGTAGCACTGGATTTTGTGACCAGCGCCGCCTGGGACTGCTGCTGCAT 3060
Qy 1021 AspSerIleGlnIleProArgGlnLeuGlyGluValAlaSerPheGlyGlySerAsnIle 1040 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3061 GATAGTATCCAGATTCCTAGACAGCTGGGAGAGGTGGCTAGTTTCGGAGGATCTAACATC 3120
Qy 1041 GluProSerValArgSerCysPheGlnPheAlaAsnAsnLysProGluIleGluAlaAla 1060 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3121 GAACCCAGCGTGCGCAGCTGTTTCCAGTTTGCCAATAACAAACCTGAAATCGAGGCTGCT 3180
Qy 1061 LeuPheLeuAspTrpMetArgLeuGluProGlnSerMetValTrpLeuProValLeuHis 1080 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3181 CTGTTCCTGGATTGGATGCGCCTGGAACCACAGAGCATGGTGTGGCTGCCTGTGCTGCAC 3240
Qy 1081 ArgValAlaAlaAlaGluThrAlaLysHisGlnAlaLysCysAsnIleCysLysGluCys 1100 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3241 AGAGTGGCTGCCGCCGAAACTGCCAAGCACCAGGCTAAATGCAACATCTGCAAGGAATGT 3300
Qy 1101 ProIleIleGlyPheArgTyrArgSerLeuLysHisPheAsnTyrAspIleCysGlnSer 1120 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3301 CCCATTATCGGCTTTCGCTACAGGAGTCTGAAACATTTTAACTACGATATTTGCCAGAGC 3360
Qy 1121 CysPhePheSerGlyArgValAlaLysGlyHisLysMetHisTyrProMetValGluTyr 1140 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3361 TGCTTCTTTTCCGGAAGAGTGGCCAAAGGACACAAGATGCACTACCCTATGGTGGAATAT 3420
Qy 1141 CysThrProThrThrSerGlyGluAspValArgAspPheAlaLysValLeuLysAsnLys 1160 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3421 TGCACCCCAACTACATCTGGCGAAGATGTGCGCGATTTTGCCAAGGTGCTGAAGAATAAG 3480
Qy 1161 PheArgThrLysArgTyrPheAlaLysHisProArgMetGlyTyrLeuProValGlnThr 1180 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3481 TTTCGGACTAAGAGGTACTTCGCCAAGCACCCCCGCATGGGGTATCTGCCAGTGCAGACA 3540
Qy 1181 ValLeuGluGlyAspAsnMetGluThrAspThrMet 1192
||||||||||||||||||||||||||||||||||||
Db 3541 GTGCTGGAAGGAGACAATATGGAGACCGATACAATG 3576
As such, the ‘051 claims represent a nucleotide species set forth in SEQ ID NO 19 of the instant broader claims to a-micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO: 8. In the instant case, SEQ ID NO: 19 encodes the amino acid sequence of SEQ ID NO: 8 (see sequence search results). It is well established that a species of a claimed invention renders the genus obvious. In re Schaumann, 572 F.2d 312, 197 USPQ 5 (CCPA 1978). Therefrom, a recombinant adeno-associated virus (rAAV) vector of instant application encompasses the recombinant AAV of ‘051. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4, 6 and 7 of copending Application No 19223409. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are directed to a recombinant adeno-associated virus (rAAV) vector comprising a-coding sequence of micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO. For instance, instant claims are directed to a recombinant adeno-associated virus (rAAV) vector comprising a-micro-dystrophin gene comprising a nucleotide sequence encoding the amino acid sequence set forth in SEQ ID NO: 8. Dependent claims limit the rAAV vector of claim 1, wherein the rAAV vector has an AAV serotype selected from AAV-1, AAV-2, AAV-3, AAV-4, AAV-5, AAV-6, AAV-7, AAV-8, AAV-9, AAV-10, AAV-11, AAV-12, AAV-13, or AAV rh.74, or a variant of each thereof subsequently limiting to an AAV serotype is of serotype AAVrh.74, or a variant thereof. Claims 5-7 are directed to the rAAV vector of claim 1, wherein the nucleotide sequence further comprises in the 5' to 3' direction an inverted terminal repeat (ITR), a muscle-specific control element, a chimeric intron sequence, the micro-dystrophin gene, a poly A tail, and an ITR, wherein the muscle-specific control element comprises the nucleotide sequence set forth in SEQ ID NO: 10 or SEQ ID NO: 11, , wherein the chimeric intron sequence comprises nucleotides 844-993 of SEQ ID NO:9 and wherein the poly A tail comprises nucleotides 4585 to 4640 of SEQ ID NO:9. Claim 9 is drawn to a composition comprising the rAAV vector of claim 1, and a pharmaceutically acceptable carrier. In contrast, claims in ‘409 are directed to use a recombinant adeno-virus associated (rAAV) serotype rh.74 comprising a polynucleotide comprising the a genetic cassette encoding a therapeutic molecule that is myodystrophy comprising SEQ ID NO: 19 operably linked to a tissue specific promoter. It is relevant to note that SEQ ID NO: 8 of instant application is encoded by SEQ ID NO: 19 of ‘051 (see sequence search result).
Conclusion
No claims allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dickson et al (USPGPUB 20170157213, EFD 6/27/2014) is the closest prior art that teaches human delta E4-R23/delta CT micro-dystrophin protein as set forth in SEQ ID NO: 3 that has 99.8% sequence homology to micro-dystrophin protein set forth in SEQ D NO: 8 pf instant application.
Qy 1 MLWWEEVEDCYEREDVQKKTFTKWVNAQFSKFGKQHIENLFSDLQDGRRLLDLLEGLTGQ 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MLWWEEVEDCYEREDVQKKTFTKWVNAQFSKFGKQHIENLFSDLQDGRRLLDLLEGLTGQ 60
Qy 61 KLPKEKGSTRVHALNNVNKALRVLQNNNVDLVNIGSTDIVDGNHKLTLGLIWNIILHWQV 120 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 KLPKEKGSTRVHALNNVNKALRVLQNNNVDLVNIGSTDIVDGNHKLTLGLIWNIILHWQV 120
Qy 121 KNVMKNIMAGLQQTNSEKILLSWVRQSTRNYPQVNVINFTTSWSDGLALNALIHSHRPDL 180 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 KNVMKNIMAGLQQTNSEKILLSWVRQSTRNYPQVNVINFTTSWSDGLALNALIHSHRPDL 180
Qy 181 FDWNSVVCQQSATQRLEHAFNIARYQLGIEKLLDPEDVDTTYPDKKSILMYITSLFQVLP 240 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 FDWNSVVCQQSATQRLEHAFNIARYQLGIEKLLDPEDVDTTYPDKKSILMYITSLFQVLP 240
Qy 241 QQVSIEAIQEVEMLPRPPKVTKEEHFQLHHQMHYSQQITVSLAQGYERTSSPKPRFKSYA 300 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 QQVSIEAIQEVEMLPRPPKVTKEEHFQLHHQMHYSQQITVSLAQGYERTSSPKPRFKSYA 300
Qy 301 YTQAAYVTTSDPTRSPFPSQHLEAPEDKSFGSSLMESEVNLDRYQTALEEVLSWLLSAED 360 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 YTQAAYVTTSDPTRSPFPSQHLEAPEDKSFGSSLMESEVNLDRYQTALEEVLSWLLSAED 360
Qy 361 TLQAQGEISNDVEVVKDQFHTHEGYMMDLTAHQGRVGNILQLGSKLIGTGKLSEDEETEV 420 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 TLQAQGEISNDVEVVKDQFHTHEGYMMDLTAHQGRVGNILQLGSKLIGTGKLSEDEETEV 420
Qy 421 QEQMNLLNSRWECLRVASMEKQSNLHRVLMDLQNQKLKELNDWLTKTEERTRKMEEEPLG 480 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 QEQMNLLNSRWECLRVASMEKQSNLHRVLMDLQNQKLKELNDWLTKTEERTRKMEEEPLG 480
Qy 481 PDLEDLKRQVQQHKVLQEDLEQEQVRVNSLTHMVVVVDESSGDHATAALEEQLKVLGDRW 540 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 PDLEDLKRQVQQHKVLQEDLEQEQVRVNSLTHMVVVVDESSGDHATAALEEQLKVLGDRW 540
Qy 541 ANICRWTEDRWVLLQDILLKWQRLTEEQCLFSAWLSEKEDAVNKIHTTGFKDQNEMLSSL 600 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 ANICRWTEDRWVLLQDILLKWQRLTEEQCLFSAWLSEKEDAVNKIHTTGFKDQNEMLSSL 600
Qy 601 QKLAVLKADLEKKKQSMGKLYSLKQDLLSTLKNKSVTQKTEAWLDNFARCWDNLVQKLEK 660 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 QKLAVLKADLEKKKQSMGKLYSLKQDLLSTLKNKSVTQKTEAWLDNFARCWDNLVQKLEK 660
Qy 661 STAQISQAVTTTQPSLTQTTVMETVTTVTTREQILVKHAQEELPPPPPQKKR-----TLE 715 |||||||||||||||||||||||||||||||||||||||||||||||||||| |||
Db 661 STAQISQAVTTTQPSLTQTTVMETVTTVTTREQILVKHAQEELPPPPPQKKRQITVDTLE 720
Qy 716 RLQELQEATDELDLKLRQAEVIKGSWQPVGDLLIDSLQDHLEKVKALRGEIAPLKENVSH 775 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 RLQELQEATDELDLKLRQAEVIKGSWQPVGDLLIDSLQDHLEKVKALRGEIAPLKENVSH 780
Qy 776 VNDLARQLTTLGIQLSPYNLSTLEDLNTRWKLLQVAVEDRVRQLHEAHRDFGPASQHFLS 835 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 VNDLARQLTTLGIQLSPYNLSTLEDLNTRWKLLQVAVEDRVRQLHEAHRDFGPASQHFLS 840
Qy 836 TSVQGPWERAISPNKVPYYINHETQTTCWDHPKMTELYQSLADLNNVRFSAYRTAMKLRR 895 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 TSVQGPWERAISPNKVPYYINHETQTTCWDHPKMTELYQSLADLNNVRFSAYRTAMKLRR 900
Qy 896 LQKALCLDLLSLSAACDALDQHNLKQNDQPMDILQIINCLTTIYDRLEQEHNNLVNVPLC 955 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 LQKALCLDLLSLSAACDALDQHNLKQNDQPMDILQIINCLTTIYDRLEQEHNNLVNVPLC 960
Qy 956 VDMCLNWLLNVYDTGRTGRIRVLSFKTGIISLCKAHLEDKYRYLFKQVASSTGFCDQRRL 1015 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 VDMCLNWLLNVYDTGRTGRIRVLSFKTGIISLCKAHLEDKYRYLFKQVASSTGFCDQRRL 1020
Qy 1016 GLLLHDSIQIPRQLGEVASFGGSNIEPSVRSCFQFANNKPEIEAALFLDWMRLEPQSMVW 1075 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 GLLLHDSIQIPRQLGEVASFGGSNIEPSVRSCFQFANNKPEIEAALFLDWMRLEPQSMVW 1080
Qy 1076 LPVLHRVAAAETAKHQAKCNICKECPIIGFRYRSLKHFNYDICQSCFFSGRVAKGHKMHY 1135 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 LPVLHRVAAAETAKHQAKCNICKECPIIGFRYRSLKHFNYDICQSCFFSGRVAKGHKMHY 1140
Qy 1136 PMVEYCTPTTSGEDVRDFAKVLKNKFRTKRYFAKHPRMGYLPVQTVLEGDNMETDTM 1192
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1141 PMVEYCTPTTSGEDVRDFAKVLKNKFRTKRYFAKHPRMGYLPVQTVLEGDNMETDTM 1197
There is no motivation to specifically delete only the “QITVD” residues from the N-terminus portion of non-adjacent R24 to modify the micro-dystrophin. Therefore, SEQ ID NO: 8 is neither disclosed nor obvious over any prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANOOP K. SINGH whose telephone number is (571)272-3306. The examiner can normally be reached Monday-Friday, 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571)272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANOOP K SINGH/Primary Examiner, Art Unit 1632