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. Claims 2-6, 11, 13, 29, 30 and 44 have been cancelled, claims 1, 12, 37 and 43 have been amended, claim 70 has been newly added. Accordingly, claims 1, 12, 23-26, 31, 37, 43, 60 and 70 are pending and under current examination.
Status of Prior Rejection/Response to Arguments
The objection of claims 37, 43 and 44 are withdrawn:
Applicant’s amendment to claim 37 and cancellation of claim 44 is effective to obviate the prior basis of the objection. The objection is withdrawn.
The rejection of claims 29 and 30 under 35 U.S.C. § 112(b) is withdrawn:
The cancellation of claims 29 and 30 renders the rejection thereto moot. The rejection is withdrawn.
The rejections of claims 1-3, 5, 6, 31, 43, 44 and 60 under 35 U.S.C. § 102(a)(1) and (a)(2) over Blumenkranz et al. is withdrawn:
The cancellation of claims 2-3, 5, 6 and 44 renders the rejection thereto moot.
Regarding claims 1, 31, 43 and 60, Applicant’s amendment to claim 1 adds the limitation that “the transgene comprises the nucleic acid of SEQ ID NO: 1”, Blumenkranz et al. do not teach the amended limitation wherein 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 The rejection is withdrawn.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 rejections of claims 1-6, 11, 31, 43, 44 and 60 under 35 U.S.C. § 103 over Blumenkranz et al. in view of Jin et al., as evidenced by Jin et al. is withdrawn:
The rejections of claims 1-6, 11, 12, 31, 43, 44 and 60 under 35 U.S.C. § 103 over Blumenkranz et al. in view of Jin et al., as evidenced by Jin et al., and further in view of Sigg et al. is withdrawn:
The rejections of claims 1-6, 11, 13, 31, 43, 44 and 60 under 35 U.S.C. § 103 over Blumenkranz et al. in view of Jin et al., as evidenced by Jin et al., and further in view of Fang et al. is withdrawn:
The rejections of claims 1-3, 5, 6, 23-26, 31, 43, 44 and 60 under 35 U.S.C. § 103 over Blumenkranz et al. in view of Gao et al. is withdrawn:
The rejections of claims 1-3, 5, 6, 29-31, 43, 44 and 60 under 35 U.S.C. § 103 over Blumenkranz et al. in view of Büning et al. is withdrawn:
The rejections of claims 1-6, 11, 13, 31, 37, 43, 44 and 60 under 35 U.S.C. § 103 over Blumenkranz et al. in view of Jin et al., as evidenced by Jin et al., and further in view of Fang et al. and Buck et al. is withdrawn:
The cancellation of claims 2-6, 11, 13, 29, 30 and 44 renders the rejection thereto moot.
Regarding claims 1, 12, 23-26, 31, 37, 43 and 60, Applicant’s amendment to claim 1 adds the limitation that “the transgene comprises the nucleic acid of SEQ ID NO: 1”, none of the references teach or suggest the amended limitation wherein 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, 43, 44 and 60 under NSDP over co-pending Application No. 17/685,457 in view of Blumenkranz et al. is withdrawn:
Applicant’s submission of the terminal disclaimer is effective to obviate the rejection on record. The rejection is withdrawn.
The rejection of claims 1-6, 11-13, 37, 43, 44 and 60 under NSDP over co-pending Application No. 17/779,793 in view of Blumenkranz et al. is maintained:
The cancellation of claims 2-6, 11, 13 and 44 renders the rejection thereto moot.
Regarding claims 1, 12, 37, 43 and 60, Applicant amends the claim 1 to recite an rAAV comprising an AAV8 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 AAV8 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 of the '793 application, which do not recite AAV8 capsid protein (Remarks, p6).
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 AAV8 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). 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 AAV8 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 AAV8 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 AAV8 capsid in the rAAV depends on their research interest. This simple substitution of one known element (AAV8 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 1-6, 11-13, 37, 43, 44 and 60 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 is effective to obviate the rejection on record. The rejection is withdrawn.
Maintained & New 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, 12, 37, 43, 60 stand provisionally rejected and claim 70 is newly provisionally rejected in modified form on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 36, 38 and 48 of co-pending Application No. 17/779,793 in view of Blumenkranz et al. (WO 2017218981 A2, published 12/21/2017). Claim 70 was newly introduced by Applicant.
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 AAV8 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). 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 AAV8 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 AAV8 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 AAV8 capsid in the rAAV depends on their research interest. This simple substitution of one known element (AAV8 capsid) for another known element (AAV2.7m8) is likely to be obvious when predictable results are achieved.
Regarding claims 12, co-pending claim 11 teaches the nucleic acid sequences of the anti-VEGF/ transgene, renders obvious to instant claim.
Regarding claim 37, co-pending claim 30 teaches the elements of the rAAV, renders obvious to the instant claim.
Regarding claim 43, co-pending claim 36 teaches a method of inhibiting VEGF or PlGF activity in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of the rAAV, renders obvious to instant claim.
Regarding claim 60, 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, corneal neovascularization (CoNV) is a type of neovascularization associated disease. Co-pending claim 38 renders obvious to instant claim.
Regarding claim 70, since the preamble “treating a corneal neovascularization (CoNV) in a subject in need thereof” and the preamble “delivering an anti-VEGF agent in a subject in need thereof” both are the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation to be given patentable weight and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See MPEP 2111.02. Co-pending claim 48 teaches the method comprising administering to the subject a therapeutically effective amount of the rAAV comprising: (i) a rAAV capsid protein, wherein the capsid protein is AAV2.7m8; and (ii) a nucleic acid comprising, in 5' to 3' order: (a) a 5' AAV ITR; (b) a CMV enhancer; (c) a chicken β-actin (CBA} promoter; (d) a chicken beta-actin intron; (e) a Kozak sequence; (f) a transgene encoding an anti-VEGF agent, wherein the anti-VEGF agent is encoded by the nucleic acid sequence in SEQ ID NO: 1; (g) a rabbit beta-globin polyA signal tail; and (h) a 3' AAV ITR renders obvious in instant claim based on the same reason discussed above.
Allowable Subject Matter
Claims 23-26 and 31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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