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 .
Specification
The disclosure is objected to because of the following informalities: The first paragraph of the specification should be amended to include updated patent information.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,295,640. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and the previously patented invention are directed towards treating a tumor in a patient using electrical pulses to cause cell membrane destruction and intracellular component spillage as well as administration of a combination of at least two immune checkpoint inhibitors and an immunomodulatory agent, wherein the at least two immune checkpoint inhibitors are a CTLA-4 inhibitor and a PD-1 inhibitor; wherein the electric field applied is in the range of 1500 V/cm to 10000V/cm; the frequency of the electric field is from 14.2kHz to 500kHz (and separately claimed 100kHz to 450kHz); wherein the pulse generator is configured to deliver, to the probe, a series of bi-polar electric pulses characterized by an instant charge reversal between positive and negative polarity to thereby cause application of the electric field to the tumor; wherein a voltage of the bi-polar electric pulses is from 0.5 kV to 10 kV; wherein each pulse has a duration of between 100 µs and 1000 µs; immunomodulatory agent comprises an agent capable of modulating myeloid cell functions; and where the immunomodulatory agent comprises Tasquinimod.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L ZINK whose telephone number is (571)270-7103. The examiner can normally be reached Monday-Friday 7-12 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hoffman can be reached at (303)297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.L.Z/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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