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 .
Applicant’s preliminary amendment filed on February 13, 2025 is acknowledged. Claims 82-101 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 19, 2024 have been considered by the examiner.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 82-101 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,070,702. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to a method for isolating recombinant adeno-associated virus (rAAV) particles from a feed composition containing rAAV particles and an impurity comprising: (a) contacting the feed composition with an anion exchange chromatography media under conditions that allow binding of the rAAV particles to the chromatography media; (b) eluting the rAAV particles from the chromatography media using a linear salt gradient; and (c) recovering an eluate comprising the eluted rAAV particles; wherein (i) the impurity comprises an empty viral capsid, partially filled viral capsid, and/or a viral aggregate, and (ii) the feed composition has a Mg2+ concentration between 0.1 mM and 20 mM, a K+ concentration between 0.1 mM and 20 mM, and a pH between about 8.2 and about 9.5.
The claims of the US Patent No. 12,070,702 are drawn to A method for isolating recombinant adeno-associated virus (rAAV) particles from a feed composition containing rAAV particles and an impurity comprising: (a) contacting the feed composition with an anion exchange chromatography media under conditions that allow binding of the rAAV particles to the chromatography media; (b) eluting the rAAV particles from the chromatography media using a linear gradient; and (c) recovering an eluate comprising the eluted rAAV particles; wherein (i) the impurity comprises an empty viral capsid, partially filled viral capsid, and/or a viral aggregate, and (ii) the method is characterized by that: a. the feed composition has a Mg2+ concentration of between about 0.1 mM and about 20 mM, b. the feed composition has a K+ concentration of between about 0.1 mM and about 20 mM, and c. the feed composition has a pH of between about 6.5 and about 10.5.
The present claims are obvious over the claims of the U.S. Patent No. 12,070,702 because they both recite the same method steps of isolating recombinant adeno-associated virus (rAAV) particles from a feed composition containing rAAV particles. The only difference between the present claims and the claims of the U.S. Patent No. 12,070,702 is the pH between about 8.2 and about 9.5 and a pH of between about 6.5 and about 10.5.
Pertinent References
Lock (WO 2017/100676 in IDS on 7/19/2024) teaches recombinant adeno-associated virus particles (see Examples 1-4). Lock teaches methods for isolating recombinant adeno-associated virus (rAAV) particles from a feed composition containing rAAV particles and an impurity comprising: (a) contacting the feed composition with an anion exchange chromatography media under conditions that allow binding of the rAAV particles to the chromatography media; (b) eluting the rAAV particles from the chromatography media using a linear gradient; and (c) recovering an eluate comprising the eluted rAAV particles; wherein (i) the impurity comprises an empty viral capsid, partially filled viral capsid (see claims 1-30, Examples 1-4). Lock teaches the feed pH of 10 (see Examples 1-4). Lock does not teach using Mg2+ concentration of between about 0.1 mM and about 20 mM, b. the feed composition of K+ at the concentration of between about 0.1 mM and about 20 mM.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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