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 .
Election/Restrictions
Applicant’s amendment filed 8/6/2025 is acknowledged. Claims 2, 7-9, 18, and 19 are cancelled. New claims 20-23 are added.
Amended claims 1, 3-6, 10-17, and 20-23 are under examination on the merits.
Response to Arguments
Applicant’s arguments, see pp. 1-4, filed 8/6/2025, with respect to the objections to the claims and rejections under 35 U.S.C. §§102 and 112 have been fully considered and are persuasive. The objections and rejections of the claims have been withdrawn.
Applicant requested the rejections for nonstatutory double patenting to be held in abeyance until the remaining rejections are resolved. Accordingly, the nonstatutory double patenting rejection over claims 1-20 of U.S. Patent No. 10,801,042 B1 in view of Clement, et al. (WO 2017112948 A1, published 6/29/2017, filed 12/23/2016; hereinafter referred to as “Clement”) is maintained for the reasons of record, and new claim 20 is added. See rejection below.
Rejections and Objections Withdrawn
The previous rejections and objections are hereby withdrawn due to Applicant’s amendment filed 8/6/2025:
Objections: claims 1, 4, & 8-10.
35 U.S.C. §112: claims 1-17.
35 U.S.C. §102: claims 1-17.
Double Patenting: claims 1-17 as being unpatentable over claims 1-20 of U.S. Patent No. 10,801,042 B1.
Claim Objections
Claims 21-23 are 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.
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.
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(Previous Rejection Maintained in Part and New Claim 20 Added) Claims 1, 3-6, 10-17 & 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,801,042 B1 in view of Clement, et al. (WO 2017112948 A1, published 6/29/2017, filed 12/23/2016; hereinafter referred to as “Clement”). The rejection of claims 2 & 7-8 is withdrawn due to cancellation of the claims. New claim 20 is added.
Although the claims at issue are not identical, they are not patentably distinct from each other because each set of claims encompasses a method for increasing the titer of recombinantly-modified adeno-associated virus (rAAV), wherein said method comprises the steps: (A) culturing cells that have been transfected with said rAAV in an initial culture medium for an initial period under conditions sufficient to permit the production of rAAV, wherein said cells additionally contain an AAV helper function-providing polynucleotide and a non-AAV helper function-providing polynucleotide; (B) changing the ionic strength of said culture medium after said initial period by adding one or more ions; and (C) continuing said culturing of said cells to thereby produce a production titer of with said rAAV that is greater than a titer obtained in the absence of step (B). U.S. Patent No. 10,801,042 B1 is limited to adding K+ ions and anions selected from the group consisting of CO32-, HCO3-, CH3COO-, SO42-, and NO3-, added at a concentration of about 40-50 mM or 30-50 mM, whereas the instant claims encompass adding K2CO3 or KHCO3 in an amount sufficient to increase the concentrations of ions in the culture medium by about 20 mM to about 50 mM. Each set of claims encompasses the production titer being 50% greater than that obtained from a similarly conducted cell culturing in the absence of (B), rAAV comprises a transgene cassette that encodes a protein or therapeutic for a genetic or heritable disease or condition, the same rAAV serotypes or hybrid thereof, cell types used in the method, and culture medium used in the method.
However, U.S. Patent No. 10,801,042 B1 does not specifically disclose adding K2CO3 or KHCO3 as the source of ions, as recited in the instant claims.
Clement teaches methods of improving rAAV production in cells, the method comprising increasing the salt concentration in the media in which the cells are infected or transfected, cultured, or in which they produce AAV (Abstract). Clement further discloses that many different salts may be used in its method (and thus a source of ions), such as potassium thioglycolate or potassium sorbate (Clement, pp. 20-21).
It would have been obvious to one of ordinary skill in the art to use the salts K2CO3 or KHCO3 as the source of ions disclosed by U.S. Patent No. 10,801,042 B1’s method because Clement teaches use potassium salts (as ion sources) to improve rAAV production in cells. One of ordinary skill in the art would have been motivated to improve rAAV yield. Therefore, Claims 1, 3-6, 10-17 & 20 were prima facie obvious to one of ordinary skill in the art before the priority date of the instant invention.
Conclusion
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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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671
/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671