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 amendments to the claims and arguments filed on June 3, 2026 have been received and entered. Claims 1, 5 have been amended, while claim 15 has been canceled. Claims 1-14, 16-24 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 was 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 were rejoined with invention of group IV (claims 20-21). Upon further consideration election of species requirement between different muscle specific promoter was hereby withdrawn. The requirement is still deemed proper and was made FINAL.
Claims 10--24 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 06/03/2026 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
Claims 1-9 were 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. Applicant’s amendment to the claims and arguments are found persuasive, therefore previous rejection of claim is hereby withdrawn. Applicants’ arguments with respect to the withdrawn rejections are thereby rendered moot.
Maintained- Double Patenting
Claims 1-9 remain 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).
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).
Response to arguments
Applicant disagree with the rejection arguing central to the equitable considerations that must be taken into account is whether the reference claims provide an "unjustified timewise extension of patent rights" of the claims at issue. Applicant argues that the issuance of the patent based on the present claims would not extend the term of any of USP 11723986, 11406717, 12491265. Applicant argues that the present application and U.S. Patent Nos. 11,723,986 and 11,406,717 each have an effective patent term filing date of April 14, 2017, and thus a presumptive 20-year term extending until April 14, 2037. However, the present application is not currently anticipated to accrue any Patent Term Adjustment (PTA) by virtue of its present status as a Track 1 application. In contrast, U.S. Patent Nos. 11,723,986 and 11,406,717 have patent terms that will extend past that of the present application in view of PTA accrued in both cases. Applicants’ arguments have been fully considered, but are not found persuasive.
In response to applicant’s argument regarding rejections 1-3, it should be noted that the issuance of the instant claims may or may not result in any unjustified timewise extension of patent term of issued patents because PTA term for instant application is not known to the Examiner at this time. Therefore, a comparison of the details between instant application and earlier issued patents cannot be made by Examiner at present and therefore rejection is maintained for the reasons of record.
Regarding rejection 4-6, because the non-provisional double patenting rejection remains on record, therefore, instant provisional ODP rejection is not the only standing rejection and hence is not overcome. Therefore, rejections are maintained for the reasons of record.
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
Qy 661 STAQISQAVTTTQPSLTQTTVMETVTTVTTREQILVKHAQEELPPPPPQKKR-----TLE 715 |||||||||||||||||||||||||||||||||||||||||||||||||||| |||
Db 661 STAQISQAVTTTQPSLTQTTVMETVTTVTTREQILVKHAQEELPPPPPQKKRQITVDTLE 720
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.
THIS ACTION IS MADE FINAL. 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.
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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/ANOOP K SINGH/ Primary Examiner, Art Unit 1632
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