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 August 21,2025 have been fully considered but they are not persuasive.
Applicant argues that “Campean does not disclose applying stimulation across the target peripheral nerve in the manner recited in claim 1. Claim 1 recites stimulation being applied between the medial and lateral sides of the target peripheral nerve. Campean is clear that stimulation is applied on the medial side only, and that that ambidexterity of the garment allows that medial side stimulation to be applied, regardless of whether the brace is applied to the right or left foot. In Campean, only one stimulation electrode is used to apply stimulation, never both. The apparatus recited in claim 1 is also ambidextrous, but the stimulation is applied across the nerve, from medial to lateral, so both stimulation electrodes are used.” (page 7 of Remarks).
Examiner respectfully disagrees. Campean et al. discloses “to optimize the stimulation field, the ability to steer current using multiple electrodes if preferred. For example, electrode pattern 8 assigns electrodes E3 and E4 as anodes and electrodes E7 and E8 as cathodes. Viewing the arrangement of these electrodes 50, 170 on the array 52, 172, it can be seen that the use of this electrode pattern could be effective on a nerve path that passes directly adjacent or between these electrode pairs. By selecting the appropriate stimulation electrodes 50, 170 from the stimulation electrode arrays 52, 172, and varying the amplitude and polarity of the current applied via the selected electrodes, the electric field applied to the subject can be shaped so that the current is steered to the target nerves. By shaping the field, the neurostimulator 10, 100 can automatically adjust to day-to-day donning and placement variability for a given subject. Current steering also allows the neurostimulator 10, 100 to work across a subject population with wide anatomical variation, for example providing a shallow field for subjects with nerves that are superficial to the skin, or a penetrating field for subjects with nerves that are deep. In the illustrated example configurations, the stimulation electrode arrays 52, 152 include six electrodes. Any number of stimulation electrodes greater than one can be used. In general, the “field steering” capability of the neurostimulator 10, 100 increases with the number of stimulating electrodes 50, 170 that are included” ([0149-0150]).
Therefore, Campean et al. does in fact disclose “wherein the control unit is configured to use the first and second stimulation electrodes to apply electrical stimulation to the target peripheral nerve by causing stimulation current to flow across the target peripheral nerve between the stimulation electrodes on the medial side of the target peripheral nerve and the stimulation electrodes on the lateral side of the target peripheral nerve” ([0146-0150]).
Likewise, the Applicant argues “Vaishya is similar to Campean in that the brace implementation is described as being versatile because it has two sets of stimulation electrodes. This allows one set of stimulation electrodes to be positioned adjacent the tibial nerve near the medial malleolus when worn on the right foot, and the other set of stimulation electrodes can be positioned adjacent the tibial nerve near the medial malleolus when worn on the left foot. See, e.g., paragraph [0056]. Like Campean, Vaishya discloses stimulating the tibial nerve at a location between the medial malleolus and the Achilles tendon to provide electrical stimulation to the tibial nerve. See, paragraph [0203]. Positioning stimulation electrode arrays on opposite sides of the adjustment band allows the brace implementation of the neurostimulator to be ambidextrous. See, paragraph [0128]. From this, it is clear that, for the same reasons set forth above regarding Campean, Vaishya does not disclose applying stimulation across the target peripheral nerve, as recited in claim 1”(page 8 of Remarks/Arguments).
Again the Examiner respectfully disagrees. Vaishya et al. discloses “to optimize the stimulation field, the ability to steer current using multiple electrodes if preferred. For example, electrode pattern 8 assigns electrodes E3 and E4 as anodes and electrodes E7 and E8 as cathodes. Viewing the arrangement of these electrodes 50, 170 on the array 52, 172, it can be seen that the use of this electrode pattern could be effective on a nerve path that passes directly adjacent or between these electrode pairs. By selecting the appropriate stimulation electrodes 50, 170 from the stimulation electrode arrays 52, 172, and varying the amplitude and polarity of the current applied via the selected electrodes, the electric field applied to the subject can be shaped so that the current is steered to the target nerves. By shaping the field, the neurostimulator 10, 100 can automatically adjust to day- to-day donning and placement variability for a given subject. Current steering also allows the neurostimulator 10, 100 to work across a subject population with wide anatomical variation, for example providing a shallow field for subjects with nerves that are superficial to the skin, or a penetrating field for subjects with nerves that are deep. In the illustrated example configurations, the stimulation electrode arrays 52, 152 include six electrodes. Any number of stimulation electrodes greater than one can be used. In general, the “field steering” capability of the neurostimulator 10, 100 increases with the number of stimulating electrodes 50, 170 that are included” ([00159-00160]).
Therefore, Vaishya et al. does in fact disclose “wherein the control unit is configured to use the first and second stimulation electrodes to apply electrical stimulation to the target peripheral nerve by causing stimulation current to flow across the target peripheral nerve between the stimulation electrodes on the medial side of the target peripheral nerve and the stimulation electrodes on the lateral side of the target peripheral nerve” ([0156-0160]).
As such for the reasons stated above and previously made of record, the claims remain rejected under Campean et al. and Vaishya et al. 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 1-14 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 lower leg, foot, or 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 at a first location on the wearable structure; a second stimulation electrode mounted on the wearable structure at a second location on the wearable structure, different than the first location on the wearable structure;
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 is configured to position the first stimulation electrode on a medial side of the target peripheral nerve, and to position the second stimulation electrode on a lateral side of the target peripheral nerve;
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 use the first and second stimulation electrodes to apply electrical stimulation to the target peripheral nerve and to record physiological responses to the applied electrical stimulation using the recording electrodes.
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;
As set forth above, the present invention is not viewed to be patentably distinct from US 11,141,587 B2.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Campean et al. (US Patent Publication 20200069942 A1).
As to claim 1, Campean et al. discloses an apparatus for applying electrical stimulation to a target peripheral nerve in a subject, comprising: a wearable structure configured to be worn on at least one of the subject's lower leg, foot, or ankle (Figures 1A-1B and 3A-3B); a first stimulation electrode mounted on the wearable structure at a first location on the wearable structure (Figures 1A-1B and 3A-3B; [0089-0090]); a second stimulation electrode mounted on the wearable structure at a second location on the wearable structure, different than the first location on the wearable structure (Figures 1A-1B and 3A-3B; [0089-0090]); one or more recording electrodes mounted on the wearable structure (Figures 1A-1B and 3A-3B; [0091]); and a control unit (depicted as 70 in Figures 1A-1B and 2B; [0094-0095]) for controlling the operation of the first stimulation electrode, the second stimulation electrode, and the one or more recording electrodes ([0047-0048, 0062]); “wherein the control unit is configured to use the first and second stimulation electrodes to apply electrical stimulation to the target peripheral nerve by causing stimulation current to flow across the target peripheral nerve between the stimulation electrodes on the medial side of the target peripheral nerve and the stimulation electrodes on the lateral side of the target peripheral nerve ([0146-0150]; Figures 1A-1B and 3A-3B), the control unit being further configured to record physiological responses to the applied electrical stimulation using the recording electrodes ([0047-0054]; Figures 1A-3B).
As to claim 2, Campean et al. discloses the controller is configured to apply the electrical stimulation to the target peripheral nerve using one of the first and second stimulation electrodes as a cathode and the other of the first and second stimulation electrodes as an anode ([0146, 0149]).
As to claim 3, Campean et al. discloses the controller is configured to apply cathodic electrical stimulation to the target peripheral nerve ([0054, 0146, 0149]).
As to claim 4, Campean et al. discloses the controller is configured to apply anodic electrical stimulation to the target peripheral nerve ([0054, 0146, 0149]).
As to claim 5, Campean et al. discloses the controller is configured to switch between applying cathodic and anodic electrical stimulation to the target peripheral nerve ([0054, 0131-0132, 0146, 0149]).
As to claim 6, Campean et al. disclose the target peripheral nerve is the tibial nerve and wherein the wearable is configured to position the first stimulation electrode medially of the tibial nerve, and to position the second stimulation electrode laterally of the tibial nerve ([0047, 0051-0052, 0123]).
As to claim 7, Campean et al. discloses the controller is configured to apply electrical stimulation laterally across the tibial nerve in a direction that acts perpendicular to the axon fibers in the tibial nerve ([0042, 0050, 0061, 0080]).
As to claim 8, Campean et al. discloses the wearable is configured to position the first stimulation electrode on a skin surface of the subject located on a medial side of a cavity between an Achilles tendon, tibia bone, and fibula bone of the subject through which the tibial nerve extends, and to position the second stimulation electrode on a skin surface of the subject located on a lateral side of the cavity ([0041, 0051-0052, 0061, 0104]; Claim 16 on page 15).
As to claim 9, Campean et al. discloses the controller is configured to apply electrical stimulation laterally across the cavity from the medial side to the lateral side and vice versa ([0041, 0051-0052, 0061, 0104]; also Claim 16 on page 15).
As to claim 10, Campean et al. discloses electrical traces (conductors, [0098]) secured to the wearable structure, wherein the electrical traces are configured to electrically connect the stimulation electrodes and recording electrodes to the control unit ([0098, 0120]).
As to claim 11, Campean et al. discloses the control unit is configured to detect via the recording electrodes the presence of an EMG response to stimulation therapy, and the control unit is further configured to: in response to detecting no EMG response, deliver stimulation therapy under open-loop control without EMG feedback ([0006-0009, 00016, 0167]); and in response to detecting an EMG response, deliver stimulation therapy under closed-loop control with EMG feedback ([0006-0009, 0016]).
As to claim 12, Campean et al. discloses the control unit is configured to determine which stimulation electrode is configured as a cathode and which stimulation electrode is configured as an anode based upon whether the apparatus is being worn on a right foot or a left foot of the user ([0146-0153]; Figures 1A-1B and 3A-3B).
As to claim 13, Campean et al. discloses the wearable comprises an ankle brace having a first portion configured to be strapped around a foot and to position the one or more recording electrodes on the foot, and a second portion configured to be strapped around an ankle to position the first stimulation electrode on a medial side of the target peripheral nerve, and to position the second stimulation electrode on a lateral side of the target peripheral nerve (Figures 1A-1B and 3A-3B).
As to claim 14, Campean et al. discloses the wearable comprises a strap having a first portion configured to be wrapped around a foot and to position the one or more recording electrodes on the foot, and a second portion configured to be strapped around an ankle to position the first stimulation electrode on a medial side of the target peripheral nerve, and to position the second stimulation electrode on a lateral side of the target peripheral nerve (Figures 1A-4D).
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vaishya et al. (WO 2020/190478 A1).
As to claim 1, Vaishya et al. discloses an apparatus for applying electrical stimulation to a target peripheral nerve in a subject (Abstract), comprising: a wearable structure configured to be worn on at least one of the subject's lower leg, foot, or ankle (Figures 1A-1B and 3A-3B); a first stimulation electrode mounted on the wearable structure at a first location on the wearable structure; a second stimulation electrode mounted on the wearable structure at a second location on the wearable structure, different than the first location on the wearable structure ([0107-0109]; Figures 1A-4D); one or more recording electrodes mounted on the wearable structure ([0110-0113]; Figures 1A-4D); and a control unit (depicted as 70 in Figure 1A-1B and 2B-2D) for controlling the operation of the first stimulation electrode, the second stimulation electrode, and the one or more recording electrodes ([0038, 0044, 0050-0055]); wherein the wearable is configured to position the first stimulation electrode on a medial side of the target peripheral nerve, and to position the second stimulation electrode on a lateral side of the target peripheral nerve ([0020, 0039-0040, 0102-0103]); wherein the control unit is configured to use the first and second stimulation electrodes to apply electrical stimulation to the target peripheral nerve and to record physiological responses to the applied electrical stimulation using the recording electrodes
Therefore, Vaishya et al. does in fact disclose “wherein the control unit is configured to use the first and second stimulation electrodes to apply electrical stimulation to the target peripheral nerve by causing stimulation current to flow across the target peripheral nerve between the stimulation electrodes on the medial side of the target peripheral nerve and the stimulation electrodes on the lateral side of the target peripheral nerve ([0156-0160]),
the control unit being further configured to record physiological responses to the applied electrical stimulation using the recording electrodes”. ([0037-0039, 0044, 0050]; Abstract).
As to claim 2, Vaishya et al. discloses the controller is configured to apply the electrical stimulation to the target peripheral nerve using one of the first and second stimulation electrodes as a cathode and the other of the first and second stimulation electrodes as an anode ([0044, 0156-0159]).
As to claim 3, Vaishya et al. discloses the controller is configured to apply cathodic electrical stimulation to the target peripheral nerve ([0044, 0156-0159]).
As to claim 4, Vaishya et al. discloses the controller is configured to apply anodic electrical stimulation to the target peripheral nerve ([0044, 0156-0159]).
As to claim 5, Vaishya et al. discloses the controller is configured to switch between applying cathodic and anodic electrical stimulation to the target peripheral nerve ([0044, 0156-0159]).
As to claim 6, Vaishya et al. discloses the target peripheral nerve is the tibial nerve and wherein the wearable is configured to position the first stimulation electrode medially of the tibial nerve, and to position the second stimulation electrode laterally of the tibial nerve ([0031, 0040-0042, 0056, 0059]; Figure 1A-1B and 3A-3B).
As to claim 7, Vaishya et al. discloses the controller is configured to apply electrical stimulation laterally across the tibial nerve in a direction that acts perpendicular to the axon fibers in the tibial nerve ([0031, 0040-0042, 0051, 0099]).
As to claim 8, Vaishya et al. discloses the wearable is configured to position the first stimulation electrode on a skin surface of the subject located on a medial side of a cavity between an Achilles tendon, tibia bone, and fibula bone of the subject through which the tibial nerve extends, and to position the second stimulation electrode on a skin surface of the subject located on a lateral side of the cavity ([0031, 0040-0042] Figure 1A-1B and 3A-3B)
As to claim 9, Vaishya et al. discloses the controller is configured to apply electrical stimulation laterally across the cavity from the medial side to the lateral side and vice versa ([0031, 0040-0042] Figure 1A-1B and 3A-3B).
As to claim 10, Vaishya et al. discloses electrical traces secured to the wearable structure, wherein the electrical traces are configured to electrically connect the stimulation electrodes and recording electrodes to the control unit ([0064-0065, 0197-0201]).
As to claim 11, Vaishya et al. discloses the control unit is configured to detect via the recording electrodes the presence of an EMG response to stimulation therapy, and the control unit is further configured to: in response to detecting no EMG response, deliver stimulation therapy under open-loop control without EMG feedback; and in response to detecting an EMG response, deliver stimulation therapy under closed-loop control with EMG feedback ([0051, 0067, 0205, 0226]; see claim 18 on page 69).
As to claim 12, Vaishya et al. discloses the control unit is configured to determine which stimulation electrode is configured as a cathode and which stimulation electrode is configured as an anode based upon whether the apparatus is being worn on a right foot or a left foot of the user (Abstract; [0055, 0156-0164, 0202-0207]).
As to claim 13, Vaishya et al. discloses the wearable comprises an ankle brace having a first portion configured to be strapped around a foot and to position the one or more recording electrodes on the foot, and a second portion configured to be strapped around an ankle to position the first stimulation electrode on a medial side of the target peripheral nerve, and to position the second stimulation electrode on a lateral side of the target peripheral nerve ([0102, 0122-0132]; Figure 1A-4D).
As to claim 14, Vaishya et al. discloses the wearable comprises a strap having a first portion configured to be wrapped around a foot and to position the one or more recording electrodes on the foot, and a second portion configured to be strapped around an ankle to position the first stimulation electrode on a medial side of the target peripheral nerve, and to position the second stimulation electrode on a lateral side of the target peripheral nerve ([0102, 0122-0132]; Figure 1A-4D).
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.
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 3796