DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-6) in the reply filed on August 20, 2026 is acknowledged.
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 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,076,561 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because US 12,076,561 B2 has been found to anticipate each and every element of the present invention, for instance both provide an introducer needle preloaded with a coiled lead having an insulated portion and an electrode formed from a deinsulated portion; percutaneously inserting the introducer needle into a body at an angle at a puncture site; depositing the electrode outside a spinal column in a region having a spinal nerve that is between a painful region and a center of the body of a patient, electrically coupling the coiled lead to a pulse generator; and stimulating the spinal nerve to recruit target fibers in the spinal nerve while minimizing recruitment of non-target fibers in the spinal nerve, wherein the electrode is within electrical proximity to and physically spaced from the spinal nerve.
As set forth above, the present invention is not viewed to be patentably distinct from US 12,076,561 B2.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of U.S. Patent No. 11,311,727. Although the claims at issue are not identical, they are not patentably distinct from each other because US 11,311,727 B2 has been found to anticipate each and every element of the present invention, for instance both provide percutaneously placing a coiled lead having an electrode within a tissue region outside a spinal column in a region having a spinal nerve that is between a painful region and a center of the body of a patient; electrically coupling the coiled lead to a pulse generator; coupling the surface stimulation return electrode to the pulse generator; and stimulating the spinal nerve to recruit target fibers in the spinal nerve while minimizing recruitment of non-target fibers in the spinal nerve, wherein the electrode is within electrical proximity to and physically spaced from the spinal nerve.
As set forth above, the present invention is not viewed to be patentably distinct from US 11,311,727 B2.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10,668,285 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because US 10,668,285 B2 has been found to anticipate each and every element of the present invention, for instance both provide a percutaneously inserting a coiled lead having an electrode and depositing the electrode outside a spinal column in a region having a spinal nerve that is between a painful region and a center of the body of a patient; and stimulating the spinal nerve to recruit target fibers in the spinal nerve while minimizing recruitment of non-target fibers in the spinal nerve, wherein the electrode is within electrical proximity to and physically spaced from the spinal nerve.
As set forth above, the present invention is not viewed to be patentably distinct from US 10,668,285 B2.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached on (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3792
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