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 .
Claims 27-29, 32-40, 44, and 50-60 are pending as amended 9/15/23, and are considered herein.
Formalities:
The drawings of 5/3/23 are accepted.
The specification of 5/3/23 is accepted.
The IDS of 9/15/23 has been considered and signed-off upon, herein.
The present Application has priority, through continuation, to 16/619,933, filed 12/5/19 (now US PAT NO 11,680,275), which is a 371 of PCT/US2018/036200, filed 6/6/18, and back to US Provisional Application No. 62/516,060, filed 6/6/17.
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 27-29, 32, 34, 36-40, 50-53, 55, and 57-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,680,275. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 27: Claim 1 teaches a nucleic acid encoding MeCP2/functional fragment, and 3’ non-coding region with at least one miRNA site, and flanked by AAV ITRs. Claim 3 teaches the miRNA site may be for miR-132. Claim 19 teaches the same, but an rAAV, and limits it to being in an AAV9 capsid, and binding site being miR-132.
Claim 28: Claim 11 teaches isoform e1.
Claim 29: Claim 12 teaches SEQ ID NO: 1, which matches present SEQ ID NO: 1.
Claim 32: Claims 3 and 19 teach “one or more” miR-132 sites, which necessarily at least covers at least two sites.
Claim 34: Claim 9 teaches that the miRNA negatively regulates expression of the transcript, and thus, the claims necessarily require a promoter. In addition, the essential written description is that these miR sites negatively regulate expression, and thus, they must be expressed, for such negative regulation (e.g., Summary of the Invention).
Claim 36: Claim 16 teaches AAV2 ITRs.
Claim 37: Claim 19 teaches the rAAV with the nucleic acid and capsid protein of AAV9.
Claim 38: Claim 19 teaches the AAV9 capsid, and thus, use of the AAV9 ITRs would be immediately known to the artisan, as the natural ITRs for this capsid.
Claim 39: Claim 17 teaches, e.g., AAV9 capsid, which facilitates BBB passage.
Claim 40: Claim 17 teaches, e.g., AAV9 capsid, which facilitates BBB passage.
Claim 50: Claim 5 teaches miR-1.
Claim 51: Claim 8 teaches miR-19.
Claim 52: Claim 7 teaches miR-22.
Claim 53: Claim 5 teaches miR-122.
Claim 55: Claims 7-8 and 20-21 each teach miR-19 and miR-22, respectively.
Claim 57: Claim 4 teaches SEQ ID NO: 6 for miR-132 binding site.
Claim 58: e.g., Claim 17 teaches AAV9.
Claim 59: Claim 19 teaches an rAAV comprising (i) a region coding MeCP2/fragment, a 3’ non-coding region comprising an miR-132 site, AAV ITRs, and (ii) an AAV9 capsid protein. Claims 20 and 21 teach they may further comprise an miR-19 and miR-22 binding sites in the non-coding region. Claim 16 teaches AAV2 ITRs may be used in the invention.
Claim 60: Claim 19 teaches the AAV9 capsid protein.
Thus, in light of the patent, the invention is obvious. The Artisan would make it, as it is claimed subject matter, and expect success, as it is claimed subject matter.
Claims 27-29, 32-34, 36-40, 50-53, 55, and 57-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,680,275, in view of Geisler, et al. (May 2016) “MicroRNA-regulated viral vectors for gene therapy”, World Journal of Experimental Medicine, 6(2): 37-54 (cited by Applicant in the IDS of 9/15/23).
As shown above, the patent makes obvious invention, except for the aspect of placing the miRNA binding site between the coding sequence, and a polyA sequence.
On the other hand, the Artisan would be aware of Geisler for its teaching of miRNA regulated viral vectors for gene therapy (e.g., TITLE). Geilser teaches to place miR sites between the coding region of the transgene and a polyA sequence (e.g., Figure 2).
Thus, in light of the patent and Geisler, the invention was obvious. The Artisan would do so, as it is taught for proper placement of the miRNA site, in the Art. The Artisan would expect success, as it is utilized for its art-recognized purposes.
Claims 27-29, 32, 34-40, 44, 50-53, 55, and 57-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,680,275, in view of Gadalla, et al. (June 2017) “Development of a Novel AAV Gene Therapy Cassette with Improved Safety Features and Efficacy in a Mouse Model of Rett Syndrome”, Molecular Therapy: Methods & Clinical Development, 5: 180-90 (cited by Applicant in the IDS of 9/15/23).
As shown above, the various aspects of the invention are obvious over the patent, however the use of an MeCP2 promoter is not specifically claimed. On the other hand, the Artisan would be aware of Gadalla for its teachings of treating Rett Syndrome with AAV vectors. Gadalla teaches the use of an MeCP2 promoter in the art (e.g., Abstract), and administration to the mouse model to treat the RTT phenotype (e.g., ABSTRACT).
Thus, in light of the patent and Gadalla, the Artisan would find the invention obvious. The Artisan would make it, in order to treat the mouse Rett Syndrome model. The Artisan would expect success, as the components are utilized for art-recognized purposes.
Allowable Subject Matter
Claim 56 is 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. To wit, while the miRNAs claimed were no, the Examiner did not find any suggestion/motivation to combine the three of them, and given the very large number of miRNAs in the Art, it is not considered obvious to try.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638