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 10/06/2025 has been received and entered. Claims 2, 6, 10 and 13 have been cancelled, claims 1, 11, 30, 36 and 38 have been amended, claims 46-50 have been new added. Accordingly, claims 1, 11, 15-17, 20, 27-31, 36-38 and 46-50 are pending and under current examination.
Status of Prior Rejection/Response to Arguments
The objection of claims 30, 36 and 38 are withdrawn:
Applicant’s amendment to claims 30 and 36 adds the full descriptions of the abbreviations “CBA” and “PIGF”, as well as the amendment to claim 38 deletes the recitation “the pharmaceutical composition of any one of claims 33-35” are effective to obviate the prior basis of the objection. The objection is withdrawn.
The rejections of claims 1, 2, 15, 16, 27, 29, 31 and 36-38 under 35 U.S.C. § 102(a)(1) and (a)(2) over Blumenkranz et al. is withdrawn:
The cancellation of claim 2 renders the rejection thereto moot.
Regarding the claims 1, 15, 16, 27, 29, 31 and 36-38, 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, therefore the amendment is effective to obviate the prior basis of the rejection. The rejection is withdrawn.
The rejections of claims 1, 2, 6, 10, 15, 16, 27, 29, 31 and 36-38 under 35 U.S.C. § 103 over Blumenkranz et al. in view of Jin et al. is withdrawn:
The rejections of claims 1, 2, 11, 15, 16, 27, 29, 31 and 36-38 under 35 U.S.C. § 103 over Blumenkranz et al. in view of Sigg et al. is withdrawn:
The rejections of claims 1, 2, 6, 10, 13, 15, 16, 27, 29, 31 and 36-38 under 35 U.S.C. § 103 over Blumenkranz et al. in view of Jin et al. and Fang et al. is withdrawn:
The rejections of claims 1, 2, 15-17, 27, 29, 31 and 36-38 under 35 U.S.C. § 103 over Blumenkranz et al. in view of Tenenbaum et al. is withdrawn:
The rejections of claims 1, 2, 15, 16, 20, 27, 29, 31 and 36-38 under 35 U.S.C. § 103 over Blumenkranz et al. in view of Feiner et al. is withdrawn:
The rejections of claims 1, 2, 15, 16, 27-29, 31 and 36-38 under 35 U.S.C. § 103 over Blumenkranz et al. in view of GeneBank Accession No KF926476.1 and Fang et al. is withdrawn:
The rejections of claims 1, 2, 15, 16, 20, 27-31 and 36-38 under 35 U.S.C. § 103 over Blumenkranz et al. in view of GeneBank Accession No KF926476.1, Fang et al. and Feiner et al. is withdrawn:
The cancellation of claims 2, 6, 10 and 13 renders the rejection thereto moot.
Regarding claims 1, 11, 15-17, 20, 27-31 and 36-38, 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 above 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, 2, 6, 10, 11, 13, 15-17, 27, 28, 30, 31 and 36-38 under NSDP over co-pending Application No. 17/639,962 in view of Blumenkranz et al. is maintained:
The cancellation of claims 2, 6, 10 and 13 renders the rejection thereto moot.
Regarding claims 1, 11, 15-17, 27, 28, 30, 31 and 36-38, Applicant amends the claim 1 to recite the transgene comprising the nucleic acid SEQ ID NO: 1, and asserts that the claimed invention is not an obvious variant of any of the claims of the ‘962 application, which do not recite AAV2.7m8 capsid protein (Remarks, p7).
Applicant’s argument is fully considered but found not persuasive. Co-pending claim 1 teaches an isolated nucleic acid, comprising: a transgene encoding an anti-vascular endothelial growth factor (anti-VEGF) agent, the transgene being flanked by inverted terminal repeats (ITRs) and comprising the nucleic acid sequence of SEQ ID NO:1, reads on the transgene expression cassette in instant claim 1. Co-pending claim 1 do not teach an rAAV comprising the nucleic acid and the AAV capsid is AAV2.7m8. However, Blumenkranz et al. teach a 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). It would have been prima facie obvious to one of ordinary skill in the art to modify the isolated nucleic acid of co-pending claim 1, and use a AAV2.7m8 as the capsid protein to obtain a rAAV as taught by Blumenkranz et al.. The skilled artisan would have been motivated to a have a rAAV which comprising anti-VEGF agent for gene therapy of e.g., eye diseases (see Blumenkranz et al. parag 0003-0005). There would be a reasonable expectation of success of having rAAV comprising the nucleic acid of anti-VEGF agent since Blumenkranz et al. teach such rAAV (see e.g., Examples, parag 0203). The rejection is maintained and modified necessitated by applicant’s amendment.
The rejection of claims 1, 2, 6, 10, 11, 30 and 36-38 under NSDP over co-pending Application No. 18/024,359 in view of Blumenkranz et al. is maintained:
The cancellation of claims 2, 6 and 10 renders the rejection thereto moot.
Regarding claims 1, 11, 30 and 36-38, Applicant argues 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.
To response, it is noted that 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”, since instant rejection is not the only rejection remaining, the double patenting rejection is maintained and modified on record necessitated by applicant’s amendment.
The rejection of claims 1, 2, 6, 10, 11, 30 and 36-38 under NSDP over co-pending Application No. 17/685,457 in view of Blumenkranz et al. is maintained:
The cancellation of claims 2, 6 and 10 renders the rejection thereto moot.
Regarding claims 1, 11, 30 and 36-38, Applicant amends the claim 1 to recite the transgene comprising the nucleic acid SEQ ID NO: 1 and request the withdrawn of the rejection (Remarks, p5).
Applicant’s amendment is found not sufficient to overcome the rejection. 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 AAV2.7m8 capsid protein, and the AAV capsid in co-pending claim 1 is AAV2/3 hybrid capsid protein. 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, 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. Blumenkranz et al. also teach 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). 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 AAV2.7m8 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 AAV2.7m8 as well as the hybrid AAV of AAV2 and AAV3 (AAV2/3 hybrid capsid) 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 AAV2/3 hybrid capsid, and use AAV capsid AAV2.7m8 in the rAAV depends on their research interest. This simple substitution of one known element (AAV2.7m8) for another known element (AAV2/3 hybrid capsid) is likely to be obvious when predictable results are achieved. The rejection is maintained and modified necessitated by applicant’s amendment.
The new/modified rejections are necessitated by applicant’s amendment.
New/Modified Rejections
Claim Objections
Claims 47 and 48 are objected to under 37 CFR 1.75 as being substantial duplicate claims with regard to the method step of administering the rAAV to any subject in need. When two claims in an application are duplicates or else are so close in content that they both cover the same method step, despite a slight difference in wording, it is proper to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Appropriate correction 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, 15-17, 27, 28, 30 and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 27, 28, 32 and 33 of co-pending Application No. 17/639, 962 in view of Blumenkranz et al. (WO 2017218981 A2, published in 2017).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, co-pending claim 1 teaches an isolated nucleic acid, comprising: a transgene encoding an anti-vascular endothelial growth factor (anti-VEGF) agent, the transgene being flanked by inverted terminal repeats (ITRs), reads on the transgene expression cassette in instant claim. Co-pending claim 1 do not teach an rAAV comprising the nucleic acid and the AAV capsid is AAV2.7m8. However, Blumenkranz et al. teach a 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). It would have been prima facie obvious to one of ordinary skill in the art to modify the isolated nucleic acid of co-pending claim 1, and use a AAV2.7m8 as the capsid protein to obtain a rAAV as taught by Blumenkranz et al.. The skilled artisan would have been motivated to a have a rAAV which comprising anti-VEGF agent for gene therapy of e.g., eye diseases (see Blumenkranz et al. parag 0003-0005). There would be a reasonable expectation of success of having rAAV comprising the nucleic acid of anti-VEGF agent since Blumenkranz et al. teach such rAAV (see e.g., Examples, parag 0203).
Regarding claims 15-17, co-pending claim 16 teaches the promoter comprises a cytomegalovirus (CMV) early enhancer, or a chimeric cytomegalovirus (CMV)/Chicken -actin (CB) promoter, renders obvious to instant claims.
Regarding claim 27, co-pending claim 27 teaches the ITRs, renders obvious to instant claim.
Regarding claim 28, co-pending claim 28 teach the sequences of the anti-VEGF agent, renders obvious to instant claims.
Regarding claim 30, co-pending claim 32 teach the recombinant adeno-associated virus (rAAV) vector elements reads on the nucleic acid in instant claim. co-pending claim 32 do not teach the AAV capsid AAV2.7m8. However, Blumenkranz et al. teach AAV2.7m8 as AAV capsid (parag 0056). It would have been prima facie obvious to one of ordinary skill in the art to modify the rAAV of co-pending claim, and use AAV2.7m8 as the capsid protein as taught by Blumenkranz et al.. The skilled artisan would have been motivated to have a targeted rAAV (e.g., AAV2.7m8) that shows higher infectivity of a specific cell, such as retinal cells, or a photoreceptor, a retinal ganglion cell, a Muller cell, a bipolar cell, an amacrine cell, a horizontal cell, or a retinal pigmented epithelium cell (parag 0087). There would be a reasonable expectation of success of having the AAV2.7m8 since Blumenkranz et al. teach 7-mer amino acid sequence LGETTRP is inserted into the GH loop of the AAV2 capsid protein, e.g., between positions 587 and 588 of the AAV2 capsid protein (parag 0056).
Regarding claims 31, co-pending claim 33 teaches the host cells comprising the isolated nucleic acid, renders obvious to instant claim.
Claims 1, 11, 30, 36-38 and 46-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 37, 43, 60 and 70 of co-pending Application No. 18/024, 359 in view of Blumenkranz et al. (WO 2017218981 A2, published in 2017) and the specification of co-pending Application No. 18/024, 359.
This is a provisional nonstatutory double patenting rejection.
Regarding claim 1 of instant claim, co-pending claim 1 teaches a recombinant adeno-associated virus (rAAV), comprising: (i) an AAV capsid protein, wherein the capsid protein is an AAV8 capsid protein or a variant thereof; and (ii) an isolated nucleic acid comprising a transgene encoding an anti-vascular endothelial growth factor (anti-VEGF) agent, the transgene being flanked by adeno- associated virus (AAV) inverted terminal repeats (ITRs), wherein the transgene comprises the nucleic acid sequence of SEQ ID NO: 1. Co-pending claim has an AAV8 capsid protein while instant claim AAV capsid AAV2.7m8 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 AAV2.7m8 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 AAV8, and use AAV2.7m8 capsid in the rAAV depends on their research interest. This simple substitution of one known element (AAV2.7m8) for another known element (AAV8) is likely to be obvious when predictable results are achieved.
Regarding claim 11, co-pending claim 12 teaches the sequences renders obvious to instant claim 11.
Regarding claims 30 and 48, co-pending claim 37 teaches a rAAV, based on the reason discussed in claim 1, co-pending claim 37 renders obvious to instant claim. In addition, it would have been prima facie obvious to one of ordinary skill in the art to modify the rAAV of co-pending claim 37, and transduce this rAAV to a host cell, as indicated in the specification of the co-pending claim (see p4, L7) to express the transgene. The skilled artisan would have been motivated to express the transgene in a host cell for anti-VEGF treatment. There would be a reasonable expectation of success of transducing the rAAV to a host cell since transducing an AAV to a cell is a well-known technology and a routine operation in the art.
Regarding claims 36 and 37, co-pending claim 43 teaches a method of inhibiting VEGF or P1GF activity in a subject in need thereof, the method comprising administering to the subject the rAAV, renders obvious to instant claim.
Regarding claim 38, co-pending claim 60 teaches a method of treating a corneal neovascularization (CoNV) in a subject in need thereof, the method comprising administering to the subject the rAAV. A corneal neovascularization (CoNV) is a neovascularization associated disease. Co-pending claim 60 renders obvious to instant claim.
Regarding claims 47-50, since the preamble “inhibiting VEGF or placenta growth factor (PlGF) activity in a subject in need thereof” (claim 47), “delivering an anti-VEGF agent in a subject in need thereof” (claim 48), “treating a neovascularization associated disease, an angiogenesis associated disease or a VEGF associated disease in a subject in need thereof” (claims 49 and 50) 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 70 recites a method comprising administering to the subject the rAAV comprising: (i) a rAAV capsid protein, wherein the capsid protein is a variant of AAV8 capsid protein or a variant thereof; and(ii) a recombinant adeno-associated virus (rAAV) vector comprising a nucleic acid comprising, in 5' to 3' order: (a) a 5' AAV ITR; (b) a cytomegalovirus (CMV) enhancer; (c) a chicken beta-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, as well as a host cell of the rAAV as indicated in the specification (see p4, L7), renders obvious to instant claims based on the reason stated above.
Claims 1, 15-17, 20, 29 and 36-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 43, 45 and 70-74 of co-pending Application No. 17/685, 457 in view of Blumenkranz et al. (WO 2017218981 A2, published in 2017).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 1 of instant claim, co-pending claim 1 teaches a recombinant adeno-associated virus (rAAV), comprising: (i) an AAV capsid protein, wherein the capsid protein is an AAV2/3 hybrid capsid protein or a variant thereof; and (ii) an isolated nucleic acid comprising a transgene encoding an anti-vascular endothelial growth factor (anti-VEGF) agent, the transgene being flanked by adeno- associated virus (AAV) inverted terminal repeats (ITRs), wherein the transgene comprises the nucleic acid sequence of SEQ ID NO: 1. Co-pending claim teach an AAV2/3 hybrid capsid protein while instant claim AAV capsid AAV2.7m8 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). AAV2/3 hybrid capsid protein is hybrid of AAV2 and AAV3. 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 AAV2.7m8 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 hybrid of AAV2 and AAV3 (AAV2/3 hybrid capsid protein) 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 AAV2/3 hybrid capsid protein, and use AAV2.7m8 capsid in the rAAV depends on their research interest. This simple substitution of one known element (AAV2.7m8) for another known element (AAV2/3 hybrid capsid protein) is likely to be obvious when predictable results are achieved.
Regarding claims 15-17, co-pending claims 70-72 teach the nucleic acid comprising the transgene 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 20, co-pending claim 73 teaches the transgene comprises a Kozak sequence.
Regarding claim 29, co-pending claim 74 teaches the rAAV is a single-stranded AAV (ssAAV).
Regarding claims 36-37, co-pending claim 43 teaches a method of inhibiting VEGF or PIGF activity in a subject in need thereof, the method comprising administering to the subject an effective amount of the rAAV, renders obvious to instant claim.
Regarding claim 38, co-pending claim 45 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 an effective amount of the rAAV, renders obvious to instant claim.
Conclusion
No claims are 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.
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/Q.G./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699