DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Applicant’s submission filed 10/10/2025 has been received and entered. Claim 44 has been cancelled, claims 1 and 43 have been amended, claims 70-74 have been new added. Accordingly, claims 1, 43, 45 and 70-74 are pending and under current examination.
Status of Prior Rejection/Response to Arguments
The objection of claims 43 and 44 are withdrawn:
Applicant’s amendment to claim 43 adds the full description of the abbreviation “PIGF”, as well as the cancellation of claim 44 are effective to obviate the prior basis of the objection. The objection is withdrawn.
The rejection of claims 1 and 43-45 under 35 U.S.C. § 102(a)(1) and (a)(2) over Blumenkranz et al. is withdrawn:
The cancellation of claim 44 renders the rejection thereto moot.
Regarding claims 1, 43 and 45, Applicant amends claim 1 to add the limitation “wherein the transgene comprises the nucleic acid of SEQ ID NO: 1”, Blumenkranz et al. do not teach the amended limitation that the transgene comprises the nucleic acid of SEQ ID NO: 1, therefore the amendment is effective to obviate the prior basis of the rejection. The rejection is withdrawn.
The Double Patenting rejection:
The rejection of claims 1 and 43-45 under NSDP over co-pending Application No. 17/639,962 in view of Blumenkranz et al. is withdrawn:
Applicant’s submission of the terminal disclaimer obviates the current rejection on record. The rejection is withdrawn.
The rejection of claims 1 and 43-45 under NSDP over co-pending Application No. 17/779,793 in view of Blumenkranz et al. is maintained:
The cancellation of claim 44 renders the rejection thereto moot.
Regarding claims 1, 43 and 45, Applicant amends the claim 1 to recite an rAAV comprising an AAV2/3 hybrid capsid protein and a transgene comprising the nucleic acid SEQ ID NO: 1, and asserts that the claims of the '793 application do not disclose an rAAV comprising a combination of a capsid of AAV2/3 hybrid and a transgene comprising the nucleic acid SEQ ID NO: 1, therefore the claimed invention is not an obvious variant of any of the claims 1 and 36-38 of the '793 application, which do not recite AAV2/3 hybrid capsid protein (Remarks, p5).
Applicant’s argument is fully considered but found not persuasive. Instant claim 1 and co-pending claim 1 both recite an rAAV comprising an AAV capsid and a transgene comprises a nucleic acid sequence encoding an anti-vascular endothelial growth factor (anti-VEGF) agent, the transgene expression cassette is flanked by AAV inverted terminal repeats (ITRs), and wherein the transgene comprises the nucleic acid of SEQ ID NO: 1. The only difference is that the AAV capsid in instant claim 1 is AAV2/3 hybrid capsid protein, and the AAV capsid in co-pending claim 1 is AAV2.7m8. The two AAV capsid proteins are obvious variants, which was disclosed by Blumenkranz et al. at the time of instant invention. Blumenkranz et al. teach a recombinant adeno-associated virus (rAAV) vector having a nucleic acid sequence that encodes an anti-VEGF agent (Abstract). In some embodiments, rAAV comprising a capsid variant (e.g., AAV2.7m8) comprises a heterologous nucleic acid sequence that encodes an anti-VEGF agent is used to deliver the sequence of the anti-VEGF gene into retinal cells upon intravitreal or subretinal injection to a subject (parag 0130). In some embodiments, pharmaceutical compositions and methods of the disclosure provide for use of any suitable AAV serotype, including AAV1, AAV2, AAV2.5, AAV3, AAV4, AAV5, AAV6, AAV7, AAV8, AAV9, AAV10, AAV11, AAV12, rh10, AAV-DJ, and any hybrid or chimeric AAV thereof (parag 0075). AAV 2/3 hybrid capsid is the hybrid AAV capsid of AAV2 and AAV3 as disclosed above. It would have been prima facie obvious to one of ordinary skill in the art to modify the rAAV of co-pending claim 1, and use a AAV2/3 hybrid capsid variant as the capsid protein to obtain a rAAV as taught by Blumenkranz et al.. Given that Blumenkranz et al. teach any suitable AAV serotype including the hybrid AAV of AAV2 and AAV3 (AAV2/3 hybrid capsid) as well as AAV2.7m8 can be used in the rAAV having a nucleic acid sequence that encodes an anti-VEGF agent, one of ordinary skill in the art would have substituted the AAV capsid AAV2.7m8, and use AAV2/3 hybrid capsid in the rAAV depends on their research interest. This simple substitution of one known element (AAV2/3 hybrid capsid) for another known element (AAV2.7m8) is likely to be obvious when predictable results are achieved.
The rejection is maintained and modified necessitated by applicant’s amendment.
The rejection of claims 1 and 43-45 under NSDP over co-pending Application No. 18/024,359 in view of Blumenkranz et al. is withdrawn:
Applicant alleges that the co-pending application 18/024,359 has a later filing date, it is not appropriate to maintain a provisional double patenting rejection in a patent application having the earlier patent term filing date over an application having a later patent term filing date.
Applicant’s argument is found persuasive. MPEP 804IB1(b)(i) states: “[I]f a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent”. Therefore the double patenting rejection is withdrawn.
Modified Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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, 43, 45 and 70-74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15-17, 20, 29, 36 and 38 of co-pending Application No. 17/779,793 in light of Blumenkranz et al. (WO 2017218981 A2, published 12/21/2017).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, co-pending claim 1 teaches a recombinant adeno-associated virus (rAAV) comprising: an adeno-associated virus (AAV) capsid containing a nucleic acid encoding a transgene expression cassette, wherein the AAV capsid is AAV2.7m8; and wherein the transgene comprises a nucleic acid sequence encoding an anti-vascular endothelial growth factor (anti-VEGF) agent, the transgene expression cassette is flanked by AAV inverted terminal repeats (ITRs), and wherein the transgene comprises the nucleic acid of SEQ ID NO: 1. Co-pending claim has an AAV capsid AAV2.7m8 while instant claim has an AAV2/3 hybrid capsid protein in the rAAV. However, the two AAV capsids are obvious variants, which was disclosed by Blumenkranz et al. at the time of instant invention. Blumenkranz et al. teach a recombinant adeno-associated virus (rAAV) vector having a nucleic acid sequence that encodes an anti-VEGF agent (Abstract). In some embodiments, rAAV comprising a capsid variant (e.g., AAV2.7m8) comprises a heterologous nucleic acid sequence that encodes an anti-VEGF agent is used to deliver the sequence of the anti-VEGF gene into retinal cells upon intravitreal or subretinal injection to a subject (parag 0130). In some embodiments, pharmaceutical compositions and methods of the disclosure provide for use of any suitable AAV serotype, including AAV1, AAV2, AAV2.5, AAV3, AAV4, AAV5, AAV6, AAV7, AAV8, AAV9, AAV10, AAV11, AAV12, rh10, AAV-DJ, and any hybrid or chimeric AAV thereof (parag 0075). AAV 2/3 hybrid capsid is the hybrid AAV of AAV2 and AAV3 disclosed above. It would have been prima facie obvious to one of ordinary skill in the art to modify the rAAV of co-pending claim 1, and use a AAV2/3 hybrid capsid variant as the capsid protein to obtain an rAAV as taught by Blumenkranz et al.. Given that Blumenkranz et al. teach any suitable AAV serotype including the hybrid AAV of AAV2 and AAV3 (AAV2/3 hybrid capsid) as well as AAV2.7m8 can be used in the rAAV having a nucleic acid sequence that encodes an anti-VEGF agent, one of ordinary skill in the art would have substituted the AAV capsid AAV2.7m8, and use AAV2/3 hybrid capsid in the rAAV depends on their research interest. This simple substitution of one known element (AAV2/3 hybrid capsid) for another known element (AAV2.7m8) is likely to be obvious when predictable results are achieved.
Regarding claim 43, co-pending claim 36 teaches a method of inhibiting VEGF or PIGF activity in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of the rAAV.
Regarding claim 45, co-pending claim 38 teaches a method of treating a neovascularization associated disease, an angiogenesis associated disease or a VEGF associated disease in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of the rAAV, anticipates instant claim.
Regarding claims 70-72, co-pending claims 15-17 teach the transgene expression cassette further comprises a promoter operably linked to the transgene, the promoter comprises a cytomegalovirus (CMV) early enhancer, and the promoter is a chimeric cytomegalovirus (CMV)/Chicken β-actin (CB) promoter.
Regarding claim 73, co-pending claim 20 teaches the transgene expression cassette comprises a Kozak sequence.
Regarding claim 74, co-pending claim 29 teaches the rAAV is a single-stranded AAV (ssAAV).
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QINHUA GU whose telephone number is (703)756-1176. The examiner can normally be reached M-F: 9:00 - 5:00.
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/Q.G./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699