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 amendment, filed 12/17/2025, has been entered.
Claims 1-142, 148, 149, 154, 155 have been canceled.
Claims 143-147, 150-153, 156-165 are pending.
Claims 147, 164, 165 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 143-146, 150-153, 156-163 are currently under examination as they read on a method for treating a neurodegenerative disease comprising administering an expression vector encoding DNase with a nervous-system specific promoter.
This Office Action will be in response to Applicant’s arguments/Remarks, filed 12/17/2025.
The Rejections of Record can be found in the previous Office Action, mailed 06/17/2025.
The previous rejection under 35 USC 112(b) has been withdrawn in view of Applicant’s amendment, filed 12/17/2025.
The previous rejection under 35 USC 112(a) has been withdrawn in view of Applicant’s amendment, filed 12/17/2025.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 143-146, 150-153, 156-163 are rejected under 35 U.S.C. 103 as being obvious over Genkin et al. (WO 2016/190780 A1, cited in IDS) in view of Kaplitt et al. (US 2012/0039991 A1) and Valles-Sanchez et al. (WO 2020104435 A1).
Applicant’s argument has been considered but has not been found convincing. The rejection of record can be found in the previous Office Action, mailed 06/17/2025.
Applicant argues that Genkin does not teach treating protein misfolding as a disease mechanism, using DNase to ameliorate protein aggregation. In response, it is noted that the neurodegenerative disease such as Alzheimer’s disease, Parkinson’s disease and ALS taught by Genkin would be associated with protein misfolding. Furthermore, by using DNase, as taught by Genkin, one would necessarily ameliorate protein aggregation.
In the same endeavor of treating neurodegenerative diseases, Kaplitt et al. taught localized delivery of rAAV comprising nucleotide sequence encoding a therapeutic agent to a specific region of the brain associated with a neurodegenerative disease that is characterized by an excess buildup of buildup of intracellular protein aggregates, e.g., Alzheimer’s disease. (see entire document). In particular, Kaplitt disclosed rAAV vectors comprising capsid protein, CMV promoter that is CNS specific promoter (paragraphs 0096, 0097, 0017). Therefore, it is not hindsight for one of ordinary skill in the art to be motivated to use a CNS-targeting promoter as taught by Kaplitt for delivering therapeutic agent such as DNase for treating neurodegenerative diseases as taught by Genkin. The rational to combine prior art teaching does not have to be limited to Applicant’s. “Obviousness can be established for achieving the claimed product for different reasons and the prior art/examiner does not need to know all of the properties of the claimed invention” In re Dillon, 16 USPQ2d 1897 (Fed. Cir. 1990); however, there must be some suggestion or motivation. Therefore, the reason or motivation to combine may often suggest doing what the inventor has done, but for a different purpose or to solve a different problem than that asserted by the inventor. See MPEP 2144.
Therefore, the rejection is 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 143-146, 150-153, 156-163 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,701,410 and claims 1-6 of U.S. patent No. 11,905,522 in view of Genkin et al. (WO 2016/190780 A1, cited in IDS), Kaplitt et al. (US 2012/0039991 A1) and Valles-Sanchez et al. (WO 2020104435 A1).
The claims of patent ‘410 disclosed a method for treating neurodegenerative disease comprising administering DNase. The claims of patent ‘522 disclosed a method for treating tumor with accumulation of cfDNA comprising administering a rAAV vector encoding DNase. The claims of either patents would render obvious of the present claims in view of Genkin, Kaplitt and Valles-Sanchez for reasons discussed above (see 103).
Applicant is silent regarding the grounds of nonstatutory double patenting rejection and therefore has been treated as acquiesces to the rejection. The rejection is therefore maintained.
Conclusion
No claim is allowed.
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 SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
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/SHARON X WEN/Primary Examiner, Art Unit 1641