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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 2, 2026 has been entered.
Response to Amendment
The amendment filed April 2, 2026 has been entered. Claims 14, 19, 28 have been amended. Claims 1-13, 24 and 27 are canceled. Currently, claims 14-23, 25-26 and 28-29 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 5-6, filed April 2, 2026, with respect to the rejection(s) of claim(s) 14 under 35 U.S.C. 103 have been fully considered and are persuasive with regard to the ordered combination of references. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Wong et al. (US 2018/0169400) as the primary reference.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16 and 18 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites, “the at least one electrode”. This references the “at least one electrode” of claim 14, line 11. However, claim 14 now also recites “at least a first electrode” (line 16) and “at least a second electrode” (line 19). While it is understood that the at least a first electrode and the at least a second electrode are considered within the umbrella limitation of the “at least one electrode” of line 11, any further reference to “at least one electrode” such as that in claim 16 is now indefinite as it is unclear if the applicant intends to refer to the first electrode, the second electrode, or another electrode.
Claim 18 recites, “the at least one electrode”. It is unclear if the applicant intends to refer to the first electrode, the second electrode, or another electrode for the same reasons as claim 16.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 14-23, 25-26 and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong et al. (US 2018/0169400) in view of Wong et al. (US 2019/0134393; hereinafter Wong et al. ‘393) and Gozani et al. (US 2013/0158627).
Regarding claim 14, Wong et al. discloses a band 900 (fig. 9a) for securing an enclosure of a wearable neurostimulation device 902 that stimulates one or more peripheral nerves of a user (“a wrist-worn device targeting the median, ulnar, and radial nerves at the wrist” [0008]), the band comprising: a platform 906 configured to at least temporarily engage with a bottom surface of the enclosure of the wearable neurostimulation device, wherein the platform is configured to at least temporarily engage with a bottom surface of the enclosure of the wearable neurostimulation device, at least in part, via one or more magnets 915 (fig. 9I; [0088]); an electrode system 904, 905, 907 configured to be electrically coupled to one or more electrical contacts 909 of the enclosure of the wearable neurostimulation device ([0088], fig. 9f) and having an inner side and an outer side, the inner side comprising at least one electrode 904 for each nerve to be stimulated; and a strap 900 configured to be coupled to at least one of the platform or the electrode system and being sized and shaped to wrap around the outer side of the electrode system when at least partially encircling a wrist of the user (fig. 9a), wherein the platform is configured to be separable from the enclosure (fig. 9a; [0088]).
Wong et al. discloses the inner side of the electrode system comprises at least a first electrode and a second electrode 904 (fig. 9a) capable of stimulating a median nerve when the electrode system and strap are wrapped at least partially encircling the wrist of the user ([0008]) but both the first and second electrode positioned so as to stimulate the median nerve. Wong et al. ‘393 teaches it is known in the art to utilize two electrode to stimulate a single nerve, where the two electrodes can have a fixed spacing to allow the electrode to stimulate the nerve from opposing sides of the nerve ([0072]) this nerve being the median nerve ([0072]) and teaches in another embodiment, two electrodes 300, 302 positioned so as to stimulate the median nerve 306 (fig. 2b-c; [0071]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wong et al. to try and position the first electrode and the second electrode 904 such that they stimulate the median nerve as taught by Wong et al. ‘393 since stimulating the median nerve with multiple electrodes is known in the art, such a modification being reasonably predictable.
Wong et al. discloses the strap 900 comprises a free end having one or more fasteners, wherein the free end of the strap is configured to be pulled by the user to tighten or adjust the strap against the wrist of the user (one band size, which can be adjustable (“e.g., via an adjustable clasp or hook and loop fastener), to accommodate users with different body part sizes” [0088]) but does not expressly disclose wherein the free end of the strap is configured to be pulled by the user and wrapped over itself to tighten or adjust the strap against the wrist of the user. Gozani et al. teaches an analogous device comprising a band (fig. 1) for securing an enclosure of a wearable neurostimulation device against an appendage of the user, the design of the band such that it comprises a free end 110 having one or more fasteners (“strap 110 is constructed from material that includes Velcro.RTM.” [0070]), wherein the free end of the strap is configured to be pulled by the user and wrapped over itself to tighten or adjust the strap against the wrist of the user (fig. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wong et al. to substitute the strap’s fastening mechanism with the mechanism as taught by Gozani et al. to enable for single handed adjustment of the band, and as it is an equivalent technique of securing a wearable neurostimulation device against the user and the selection of these known equivalents would be within the level of ordinary skill in the art, such a modification being reasonably predictable in the art.
Regarding claim 15, Wong et al. discloses the electrode system comprises a distal end 904 and a proximal end 907, and wherein only the proximal end is coupled to the platform (fig. 9a).
Regarding claim 16, Wong et al. discloses wherein the electrode system comprises one or more electrical traces 905 extending between the proximal end and the at least one electrode.
Regarding claim 17, Wong et al. in view of Gozani et al. discloses wherein the strap extends through an aperture to facilitate tightening or adjusting of the strap (fig. 1).
Regarding claim 18, Wong et al. discloses wherein the strap is configured to be tightened against the outer side of the electrode system forcing the at least one electrode firmly against skin of the user ([0084]).
Regarding claim 19, Wong et al. in view of Gozani et al. discloses wherein a distal end of the strap comprises an aperture sized and shaped to slidingly receive the strap, (fig. 1; “tightening strap 110 so as to secure electrode array 120 against the skin of the patient” [0071]).
Regarding claim 20, Wong et al. in view of Gozani et al. discloses wherein the aperture is configured to inhibit the distal end of the electrode system from sliding along the wrist of the user when both ends of the strap are secured relative to the platform (fig. 1; “tightening strap 110 so as to secure electrode array 120 against the skin of the patient” [0071]).
Regarding claim 21, Wong et al. discloses wherein the platform further comprises an engagement structure configured to secure the enclosure to the platform (“the receptacle 906 can have a clip, retaining lip, magnet, a snap fit, a twist fit, a hook, a latch, a sliding mechanism, or other securement feature for reversibly securing the therapy unit 902 to the band 900” [0088]).
Regarding claim 22, Wong et al. discloses the platform is flexible (“a flexible lip 913 around the opening of the receptacle that can be used to retain the therapy unit 902 after it is inserted into the receptacle 906” [0088]).
Regarding claim 23, Wong et al. discloses wherein the one or more magnets of the platform are configured to align with corresponding one or more magnets of the enclosure of the wearable neurostimulation device (fig. 9I), and wherein the one or more magnets of the platform and of the wearable neurostimulation device are configured to pull the platform against the bottom surface of the enclosure ([0088]).
Regarding claim 25, Wong et al. discloses wherein the platform is asymmetric such that the enclosure can be attached in a single orientation (fig. 9f; electrical contact points 909 are positioned only on one side of the enclosure of the wearable neurostimulation device for contacting with electrical contact points 907 located on the platform, therefore interpreted as asymmetric such that the enclosure can be attached in a single orientation).
Regarding claim 26, Wong et al. discloses wherein a first shape of the enclosure of the wearable neurostimulation device 902 engages with a second shape of the band 900 when the enclosure is secured to the band (fig. 9A, F-I).
Regarding claim 28, Wong et al. does not expressly disclose further comprising a third electrode positioned so as to stimulate an ulnar nerve when the electrode system and strap are wrapped at least partially encircling the wrist of the user. Wong et al. ‘393 teaches it is known in the art to stimulate both the median nerve using two electrodes and the ulnar nerve using an additional electrode (“utilize two electrodes to stimulate a single nerve …Similarly, other embodiments can utilize more than three electrodes. For instance, an additional electrode can be added to target the ulnar nerve.” [0072]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wong et al. to include a third electrode positioned so as to stimulate an ulnar nerve as taught by Wong et al. ‘393 since it is known in the art, such a modification being reasonably predictable.
Regarding claim 29, Wong et al. in view of Gozani et al. discloses wherein the one or more fasteners comprise one or more hook fasteners configured to couple to one or more complementary loop fasteners positioned along the strap (“Velcro” [0070]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Buckley et al. (US 2020/0367775) teaches stimulation of various peripheral nerves (median, radial, ulnar) with a wristband through the use of a plurality of electrodes to each of the peripheral nerves (fig. 5b).
Carballo et al. (US 11,839,583) teaches a loop mechanism 51 on a wearable device to allow for single handed adjustment of the wearable device band 51 (fig. 5).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (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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/ERICA S LEE/Primary Examiner, Art Unit 3796
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