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 April 14, 2026 have been received and entered. Claim 1 has been amended, while claims 13-14 are canceled.
Claims 1-12 are pending in the instant application.
Priority
This application is a continuation of US application no 16/553,235 filed on 08/28/2019 that is a Continuation of US application no 15/303,834 filed on 10/13/2016, which is a 371 of PCT/EP2015/059099 filed on 04/27/2015 that claims priority from foreign applications
EP 14305622.4 filed on 04/25/2014 and EP 14196400.7 filed on 12/04/2014.
Claims 1-12 are under consideration.
Withdrawn Claim Rejections - 35 USC § 112-new matter
Claims 1, 3-13 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. Applicant’s amendments to the base claim deleting the phrase consists of the elimination of ATG start codons at positions 308-310 and 363-364 of SEQ ID NO:5 by way of nucleotide substitution(s), previous rejection of claim is hereby withdrawn. Applicants’ arguments with respect to the withdrawn rejections are thereby rendered moot.
Withdrawn -Claim Rejections - 35 USC § 112
Claim 13 was rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. Applicants’ cancellation of claim 13 renders its rejections moot.
Withdrawn-Claim Rejections - 35 USC § 112
Claim 2 was rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicants’ cancellation of claim 2 renders its rejections moot.
Maintained-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, 3-12 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11339406 and Kay et al (WO/2007/120533, 10/25/2007, art of record). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed modified HBB2 intron is structurally and functionally same as one encompassed by the claims in ‘406. In the instant case, claims are directed to an intron which is a modified HBB2 intron as compared to the HBB2 intron shown in SEQ ID NO:5, wherein the modification consists of SEQ ID NO:6. Claim 3 is directed to a nucleic acid construct comprising the intron according to claim 1, further comprising a transgene and one or more additional expression control sequences, and wherein the said additional expression control sequence is a ubiquitous or tissue-specific promoter. Claim 6 is directed to a vector comprising the intron according to claim 1, which is a viral vector (claim 7), wherein said viral vector is a single-stranded or double-stranded self-complementary AAV vector, wherein the AAV vector has an AAV-derived capsid subsequently limiting to an AAV8 capsid that is a pseudotyped AAV vector. Claim 12 is directed to a cell transformed with the nucleic acid construct according to claim 3.. In contrast, claims in ‘406 are directed to a recombinant adeno-associated virus (AAV) vector comprising an expression cassette, said expression cassette comprising a nucleic acid molecule encoding a truncated human acid alpha-glucosidase (hGAA) polypeptide, wherein said nucleic acid molecule is operably linked to a promoter and wherein said expression cassette optionally comprises an intron (claim 12), wherein the intron is a HBB2 intron that comprises SEQ ID NO: 22 to SEQ ID NO: 26. It is noted that SEQ ID NO: 6 of instant application is encompassed by SEQ ID NO: 22-26 of ‘406. The claims in '406 differs from claimed invention by not disclosing nucleic acid comprising the modified intron is part of AAV that is AAV8 or isolate Hbb2 intron. It would be obvious for one of ordinary skill in the art seeking to study the role of intron to increase mRNA stability and the production of the protein would isolate HBB2 intron from the construct disclosed in ‘406 with reasonable expectation of success. Further, Kay cures the deficiency by teaching a nucleic acid comprising modified intron could be incorporated in AAV vector more specifically an scAAV or more preferably and AAV8 vector (see page 12, lines 29-34) comprising said modified intron and a therapeutic sequence under the control of a liver-specific promoter to express gene of interest in a liver cell (see figure 3, pages 12, lines 19-24, page 16, lines 9-11 and claims 1-15, example 2). Kay teaches a method of expressing said nucleic acid vector in a subject in need thereof (see claim 8-14, example 2). Therefore, it would have been obvious to one of ordinary skill in the art to isolate the modified intron from the construct and incorporate the construct comprising modified intron as disclosed in '406 to in an AAV or AAV8 vector for expressing said nucleic acid vector in a subject in need thereof as disclosed in Kay.
Query Match 100.0%; Score 441; Length 4198;
Best Local Similarity 100.0%;
Matches 441; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GTACACATATTGACCAAATCAGGGTAATTTTGCATTTGTAATTTTAAAAAATGCTTTCTT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 831 GTACACATATTGACCAAATCAGGGTAATTTTGCATTTGTAATTTTAAAAAATGCTTTCTT 890
Qy 61 CTTTTAATATACTTTTTTGTTTATCTTATTTCTAATACTTTCCCTAATCTCTTTCTTTCA 120 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 891 CTTTTAATATACTTTTTTGTTTATCTTATTTCTAATACTTTCCCTAATCTCTTTCTTTCA 950
Qy 121 GGGCAATAATGATACAATGTATCATGCCTCTTTGCACCATTCTAAAGAATAACAGTGATA 180 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 951 GGGCAATAATGATACAATGTATCATGCCTCTTTGCACCATTCTAAAGAATAACAGTGATA 1010
Qy 181 ATTTCTGGGTTAAGGCAATAGCAATATTTCTGCATATAAATATTTCTGCATATAAATTGT 240 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1011 ATTTCTGGGTTAAGGCAATAGCAATATTTCTGCATATAAATATTTCTGCATATAAATTGT 1070
Qy 241 AACTGATGTAAGAGGTTTCATATTGCTAATAGCAGCTACAATCCAGCTACCATTCTGCTT 300 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1071 AACTGATGTAAGAGGTTTCATATTGCTAATAGCAGCTACAATCCAGCTACCATTCTGCTT 1130
Qy 301 TTATTTTCTGGTTGGGATAAGGCTGGATTATTCTGAGTCCAAGCTAGGCCCTTTTGCTAA 360 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1131 TTATTTTCTGGTTGGGATAAGGCTGGATTATTCTGAGTCCAAGCTAGGCCCTTTTGCTAA 1190
Qy 361 TCTTGTTCATACCTCTTATCTTCCTCCCACAGCTCCTGGGCAACCTGCTGGTCTCTCTGC 420 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1191 TCTTGTTCATACCTCTTATCTTCCTCCCACAGCTCCTGGGCAACCTGCTGGTCTCTCTGC 1250
Qy 421 TGGCCCATCACTTTGGCAAAG 441
|||||||||||||||||||||
Db 1251 TGGCCCATCACTTTGGCAAAG 1271
Response to arguments
Applicant disagree with the rejection arguing the claims of the present application would not extend the protection of the same invention claimed within the '406 patent nor is there any evidence of record (that qualifies as prior art) that establishes that the claimed invention is an obvious variation. Applicants’ arguments have been fully considered, but are not found persuasive.
In response, it is noted that claims 3-9, 11 and 12 are broad and directed to a nucleic acid encoding construct comprising the intron of the invention, further comprising any transgene and one or more additional expression control sequence. Dependent claims limit the tissue specific or ubiquitous promoter. Claims are also directed to any vector comprising the intron of the invention, wherein the vector is a viral vector or ssAAV vector. In contrast, claims in ‘406 directed to a recombinant adeno-associated virus (AAV) vector comprising an expression cassette, said expression cassette comprising a nucleic acid molecule encoding a transgene (truncated human acid alpha-glucosidase (hGAA) polypeptide, said truncated hGAA polypeptide), wherein said nucleic acid molecule is operably linked to a promoter (claim 9) , wherein said promoter is a liver-specific promoter (claims 10-11), wherein expression cassette comprises a HBB2 intron (claim 14), wherein said DNA construct comprises the nucleic acid of SEQ ID NO: 22-26 claim 15). It is noted that claims 22-26 encompass hbb2 intron set forth in SEQ ID NO: 6. As such, the ‘406 claims represent a species of the instant broader claims 3-9, 11 and 12. 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).
Regarding claims 1 and 10 of instant application, it would have been obvious to one of ordinary skill in the art to modify the rAAV of ‘406 by using AAV8 vector as disclosed in Kay, with reasonable expectation of success. One of ordinary skill in the art would be motivated to do so because prior art teaches AAV8 vector is more efficient at gene transfer in vivo than AA V-2 vectors (see page 12, lines 29-33 of Kay). It would have been further obvious to one of ordinary skill in the art seeking to study the role of intron to increase mRNA stability and the production of the protein would be motivated to isolate HBB2 intron from the construct disclosed in ‘406 with reasonable expectation of success.
Therefore, in view of the fact patterns of the instant case, and the ground of rejection outlined by the examiner, applicants' arguments are not compelling and do not overcome the rejection of record.
Conclusion
No claims allowed.
bacpacresources.org/library. php?id=107), 2007 teaches pTARBAC2.1 vector map:
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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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