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 .
Priority
The instant application is a national stage entry of PCT application PCT/US2022/018976, filed 08/30/2023 under 35 USC 371. Acknowledgement is made of the applicant’s claim for benefit to prior-filed U.S. provisional patent applications 63/156,657, which was filed 03/04/2021.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “a first transgene sequence” in e), however, there is no “second” transgene sequence in the claim, therefore it is recommended to delete the word “first” in the recitation. Appropriate correction is required.
Claims 25, 27-29, 31, 39 and 46 depend from, at least, claim 1, and thus inherit the deficiency and are objected on the same basis.
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 21 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 42 of co-pending Application No. 18/263,793 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claim renders obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claim 21 is directed to an AAV piggyBac transposon polynucleotide comprises the nucleic acid sequence of SEQ ID NO:36, instant claim 25 is directed to an AAV piggyBac transposon polynucleotide comprises the nucleic acid sequence of SEQ ID NO:40. Co-pending claim 42 is directed to a composition which comprises adeno-associated virus (AAV) viral vector particles and lipid nanoparticles, wherein the AAV viral vector particles comprise a nucleic acid sequence at least 95% identical to any one of SEQ ID NOs:15-20. The nucleic acid sequence of SEQ ID NO:15 in co-pending claim 42 is 100% identical to SEQ ID NO:36 of instant claim 21, and the nucleic acid sequence of SEQ ID NO:19 in co-pending claim 42 is 100% identical to SEQ ID NO:40 of instant claim 25 (alignment is attached). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of co-pending claim 42, and have the AAV viral vector particles the nucleic acid sequence of SEQ ID NOs 15 and 19 which comprising a transposon, wherein the transposon comprises a nucleotide sequence encoding therapeutic protein. The skilled artisan would have been motivated to obtain the AAV viral particles encoding therapeutic protein for the treatment. There would be a reasonable expectation of success of obtaining the AAV viral particles since co-pending claim 42 provides the nucleic acid sequence of the AAV viral particles. Therefore the AAV viral vector particles of co-pending claim 42 render obvious to instant claims.
Allowable Subject Matter
Claims 9 and 47-51 are allowed.
Claims 1, 27-29, 31, 39 and 46 would be allowable if rewritten or amended to overcome the objection set forth in this Office action.
Claims 1 and 9 are directed to AAV piggyBac transposon polynucleotides comprising AAV ITR, piggyBac ITR, insulator, promoter, transgene, polyA and DNA space sequence, wherein the transgene sequence comprising the nucleic acid sequence of SEQ ID NO: 23 is free of the art. Therefore the piggyBac transposon polynucleotides comprising the nucleic acid sequence of SEQ ID NO: 23 is considered novel and allowable.
Conclusion
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/Q.G./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
Sequence alignment
SEQ ID NO:36 v.s. SEQ ID NO:15 in co-pending Application No. 18/263,793
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92
622
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680
782
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743
742
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741
735
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828
742
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747
742
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452
786
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SEQ ID NO:40 v.s. SEQ ID NO:19 in co-pending Application No. 18/263,793
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96
713
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372
776
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745
730
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746
766
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752
761
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823
743
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750
757
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823
747
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823
788
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