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 .
Response to Arguments
Applicant's arguments filed May 23, 2026 have been fully considered in light of the amendment to claim 1 in accordance to the species requirement issued on March 24, 2026. The arguments submitted on December 18, 2025 in regards to the rejections under 35 U.S.C. 102 and 35 U.S.C. 103 have been fully considered and are persuasive. However, the non-statutory double patenting rejections still stand. As such, the claims remain rejected as detailed below.
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,141,587 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because US 11,141,587 B2 has been found to anticipate each and every element of the present invention for instance both provide:
18/107,241 (claim 1)
US 11,141,587 B2 (claim 1)
applying electrical stimulation to a target peripheral nerve in a subject
applying transcutaneous electrical stimulation to a target peripheral nerve of a subject
a wearable structure configured to be worn on at least one of the subject's foot and ankle;
(wearable electrodes are configured to be “positioned” on a skin surface and are thus on a “wearable structure” on the skin surface.)
a first stimulation electrode mounted on the wearable structure; a second stimulation electrode mounted on the wearable structure at a location spaced from the first stimulation electrode;
positioning a plurality of stimulation electrodes on a skin surface proximate the targeted peripheral nerve, the stimulation electrodes being spaced from each other in a predetermined configuration;
one or more recording electrodes mounted on the wearable structure;
positioning one or more recording electrodes on a skin surface remote from the stimulation electrodes
and a control unit for controlling the operation of the first stimulation electrode, the second stimulation electrode, and the one or more recording electrodes;
applying electrical stimulation pulses via the selected stimulation electrode pattern (via a control unit); generating a stimulation pulse using the selected stimulation electrode pattern according to its associated stimulation parameters; d) determining via the recording electrodes whether the stimulation pulse using the selected stimulation electrode pattern elicited an EMG response;
wherein the wearable structure is anatomically configured to position the first stimulation electrode on a medial side of a trunk of the target peripheral nerve, and to position the second stimulation electrode on a lateral side of the same trunk of the target peripheral nerve, such that the target peripheral nerve extends between the first and second stimulation electrodes;
positioning a plurality of stimulation electrodes on a skin surface proximate the targeted peripheral nerve, the stimulation electrodes being spaced from each other in a predetermined configuration; at a location where electromyogram (EMG) responses to electrical stimulation of the targeted peripheral nerve can be detected;
wherein the control unit is configured to assign one of the first and second stimulation electrodes as a cathode and the other as an anode and to apply electrical stimulation that causes stimulation current to flow transversely through the target peripheral nerve from the medial side toward the lateral side or from the lateral side towards the medial side, substantially perpendicular to axon fibers of the target peripheral nerve;
generating a stimulation pulse using the selected stimulation electrode pattern according to its associated stimulation parameters; d) determining via the recording electrodes whether the stimulation pulse using the selected stimulation electrode pattern elicited an EMG response; e) adding the selected stimulation electrode pattern to the pattern list in response to detecting an EMG response;
and wherein the control unit is further configured to record physiological responses to the applied electrical stimulation using the one or more recording electrodes.
stimulating the peripheral nerve by applying electrical stimulation pulses via a stimulation electrode pattern selected from the plurality of stimulation electrodes according to stimulation parameters under closed-loop control in which EMG responses to the electrical stimulation pulses are monitored via the recording electrodes and the stimulation parameters are adjusted in response to the monitored EMG responses; (claim 5)
As set forth above, the present invention is not viewed to be patentably distinct from US 11,141,587 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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 3796
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