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 Amendment
The amendment filed August 22, 2025 has been entered. Claims 14, 17, 19-20, 22-24 have been amended. Claims 1-13 are canceled. Claims 27-29 are new. Currently, claims 14-29 are pending for examination.
Response to Arguments
Applicant’s arguments, see page 5, filed August 22, 2025, with respect to the rejection(s) of claim(s) 14-21 under 35 U.S.C. 102(a)(1) and/or (a)(2) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.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), specifically to address the limitations directed to “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”.
With respect to applicant’s arguments (p. 5-6) directed to the prior art not disclosing “a strap 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”, applicant argues Gozani et al. (US 2013/0158627) states “a key feature of the present invention is that the TENS device and its associated electrode array are designed for easy, rapid, and clinically valid placement of the electrode array by a patient seeking pain relief in the feet and/or lower legs” ([0015]). Applicant argues, “One of ordinary skill would not think to configure the device for placement on a wrist when the desired pain treatment location is in the feet or legs” (p. 6). In response, the focused key feature of the device appears to provide easy, rapid, and clinically valid placement of the electrode array by a patient seeking pain relief in an extremity, and not necessarily requiring the feet and/or lower legs. Applicant has not provided evidence that the device of Gozani et al. would not be able to be used on a wrist of the user. Burden shifts to applicant to show that the element shown in the prior art is not an equivalent of the structure, material or acts disclosed in the application. In re Mulder, 716 F.2d 1542, 219 USPQ 189 (Fed. Cir. 1983). If applicant takes the position that the sizing of the device of Gozani et al. would be unable to be used on the wrist, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Claim Objections
Claim 19 is objected to because of the following informalities: line 1 recites “the distal end of the strap” but it appears it should state “the distal end of the electrode system” as introduced in claim 15. Appropriate correction is required.
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.
Claim 24 is 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. This claim recites stimulating one or more peripheral nerves from the group comprising: …a sural nerve, a femoral nerve, a peroneal nerve, a saphenous nerve, or a tibial nerve”. However with the amendments to claim 14 requiring the device at least partially encircling the wrist, the targeting of the sural, femoral, peroneal, saphenous and tibial nerves is now indefinite because these nerves are not located within the wrist.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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) 14-24, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani et al. (US 2013/0158627) in view of Wong et al. (US 2018/0169400).
Regarding claim 14, Gozani et al. discloses a band (fig. 1) for securing an enclosure of a wearable neurostimulation device 105 that stimulates one or more peripheral nerves of a user ([0006], [0010], [0088]), the band comprising: a platform (interpreted as (1) a portion of the electrode array 120 see fig. 2 or (2) a portion of strap configured to interface with 105, see annotated figure below) configured to at least temporarily engage with the enclosure of the wearable neurostimulation device (“It is also possible to make the strap removable from stimulator 105” [0070]); an electrode system 120 configured to be electrically coupled to one or more electrical contacts of the enclosure of the wearable neurostimulation device ((1)“electrode array 120 comprises electrical contacts 210, 212” [0066], fig. 2; (2)“Strap 110 may also include a mechanism (not shown), such as a clip, for holding the ends of electrode array 120 in place” [0070]) and having an inner side and an outer side, the inner side comprising at least one electrode 202, 204, 206, 208 (fig. 1, 6; [0074]) for each nerve to be stimulated; and a strap 110 configured to be coupled to at least one of the platform or electrode system ((1) )“Strap 110 may also include a mechanism (not shown), such as a clip, for holding the ends of electrode array 120 in place” [0070]; (2) portion of the strap is the platform) and being sized and shaped to wrap around the outer side of the electrode system when at least partially encircling the limb of the user (fig. 1), wherein the strap comprises a free end having one or more fasteners, 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 limb of the user, and wherein the platform is configured to be separable from the enclosure (“It is also possible to make the strap removable from stimulator 105” [0070]).
Gozani et al. does not expressly disclose the limb is the wrist of the user. However it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the device of Gozani et al. would be capable of being used on a wrist of the user. Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gozani et al. to change the dimensions of the device such that it would be sized to at least partially encircle a wrist of the user since a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Gozani et al. does not expressly disclose 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. Wong et al. teaches a similar band 900 for securing an enclosure of a wearable neurostimulation device 902, where the band comprises a platform 906 (“receptacle” [0088]) to at least temporarily engage with the enclosure of the wearable neurostimulation device (fig. 9a), 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]). It would have been obvious to one of ordinary skill in the art before he effective filing date of the claimed invention to modify Gozani et al. to use magnets to temporarily engage the platform with the bottom surface of the enclosure of the wearable neurostimulation device as taught by Wong et al. in order to provide a securing mechanism to better retain the neurostimulation device to the platform ([0088]).
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Regarding claim 15, Gozani et al. discloses the electrode system 120 comprises a distal end and a proximal end, wherein only the proximal end is coupled to the platform (fig. 2).
Regarding claim 16, Gozani et al. discloses wherein the electrode system comprises one or more electrical traces extending between the proximal end and the at least one electrode (“printed silver traces” [0074]).
Regarding claim 17, Gozani et al. discloses wherein the strap extends through an aperture to facilitate tightening or adjusting of the strap (fig. 1).
Regarding claim 18, Gozani 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 (fig. 1; “tightening strap 110 so as to secure electrode array 120 against the skin of the patient” [0071]).
Regarding claim 19, Gozani et al. discloses wherein the 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, 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, Gozani et al. discloses wherein the platform further comprises an engagement structure 210, 212 configured to secure the enclosure to the platform ([0066], [0074]).
Regarding claim 22, Gozani et al. discloses wherein the platform is flexible ((1) fig. 2 shows flexible portion of electrode array 120 folded back, (2) portion of strap is flexible as it is made of Velcro allowing securement to variety of appendage sizes [0070]).
Regarding claim 23, Gozani et al. in view of Wong et al. disclose 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 24, Gozani et al. does not expressly disclose wherein the band is configured to position the enclosure to stimulate one or more peripheral nerves from the group comprising: a median nerve, a radial nerve, an ulnar nerve, a sural nerve, a femoral nerve, a peroneal nerve, a saphenous nerve, or a tibial nerve. Wong et al. teaches commonly stimulated nerves in the wrist include the median nerve or the radial nerve ([0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the band of Gozani et al., when used to at least partially encircle the wrist, would be capable of positioning the enclosure to stimulate the median nerve or the radial nerve given Wong et al. teaches these nerves are common in the wrist location.
Regarding claim 29, 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]).
Claim(s) 14, 21, 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zabaleta et al. (EP 3,650,077) in view of Wong et al. (US 2018/0169400).
Regarding claim 14, Zabaleta et al. discloses a band (fig. 1a) for securing an enclosure of a wearable neurostimulation device 1 that stimulates one or more peripheral nerves of a user ([0003]) the band comprising: a platform 8 configured to at least temporarily engage with the enclosure of the wearable neurostimulation device (“The stimulator 1 is a separate part of the device 100 and is designed to be housed in socket 8” [0039]; “quick mounting of the stimulator in the socket” [0049]); an electrode system 9 configured to be electrically coupled to the one or more electrical contacts 33 of the enclosure of the wearable neurostimulation device (“output pins 33 of the stimulator 1 are electrically connected to the conductive paths 93 of the electrode 9, 9A, 9B, and therefore electrically connected to respective electrode pads 91” [0037]) and having an inner side and an outer side, the inner side comprising at least one electrode 91 for each nerve to be stimulated; and a strap 10 configured to be coupled to at least one of the platform or the electrode system (“The electrode 9 is designed to be attached to or in contact with the garment 10, thus being carried by the garment 10 in a stationary or fixed condition, in such a way that the electrode pads 91 comprised in the electrode 9 are disposed on fixed positions of the garment 10” [0032]; “the garment 10, such as textile or fabric garment, defines a hollow area 60 of substantially the same size and shape as the socket 8. The hollow area is designed to receive the socket 8.” [0035]) and being sized and shaped to wrap around the outer side of the electrode system when at least partially encircling a limb of the user (fig. 1a); wherein the strap comprises a free end 11a,b having one or more fasteners 11a,b, 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 limb of the user (fig. 1a, 8b), and wherein the platform is configured to be separable from the enclosure ([0049]).
Zabaleta et al. discloses a possible implementation of the invention is to use the device on a user’s arm (fig. 1c), but does not expressly disclose the limb is the wrist of the user. However it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the device of Zabaleta et al. would be capable of being used on a wrist of the user. Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zabaleta et al. to change the dimensions of the device such that it would be sized to at least partially encircle a wrist of the user since a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Zabaleta et al. discloses a snap fit mechanical coupling between the platform 8 and the enclosure 1 ([0049]) and does not expressly disclose 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. Wong et al. teaches a similar band 900 for securing an enclosure of a wearable neurostimulation device 902, where the band comprises a platform 906 (“receptacle” [0088]) to at least temporarily engage with the enclosure of the wearable neurostimulation device (fig. 9a), 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]). It would have been obvious to one of ordinary skill in the art before he effective filing date of the claimed invention to modify Zabaleta et al. to substitute and use magnets to temporarily engage the platform with the bottom surface of the enclosure of the wearable neurostimulation device instead of the snap fit mechanical coupling as taught by Wong et al. as it is an equivalent securement feature to a clip, snap fit mechanism, twist fit mechanism, hook, etc. in order to provide a securing mechanism to better retain the neurostimulation device to the platform ([0088]).
Regarding claim 21, Zabaleta et al. discloses wherein the platform 8 further comprises an engagement structure configured to secure the enclosure to the platform (“the stimulator 1 has two flanges 17, 18 (see for example Figure 5A) configured to match corresponding recesses 81, 82 (see for example Figure 1 or Figure 5A) in socket 8… the socket 8 has a recess 83 configured to match a corresponding protrusion 19 in the stimulator 1… the socket 8 has a plurality of landmarks 85 (for example, three landmarks 85 are illustrated) designed to match respective holes 95 made on portion 921 of the electrode 9A, 9B, in order to guarantee the correct positioning of the electrode 9A, 9B on the socket 8” [0049]).
Regarding claim 23, Zabaleta et al. in view of Wong et al. disclose 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 24, Zabaleta et al. does not expressly disclose wherein the band is configured to position the enclosure to stimulate one or more peripheral nerves from the group comprising: a median nerve, a radial nerve, an ulnar nerve, a sural nerve, a femoral nerve, a peroneal nerve, a saphenous nerve, or a tibial nerve. Wong et al. teaches commonly stimulated nerves in the wrist include the median nerve or the radial nerve ([0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the band of Zabaleta et al., when used to at least partially encircle the wrist, would be capable of positioning the enclosure to stimulate the median nerve or the radial nerve given Wong et al. teaches these nerves are common in the wrist location.
Regarding claim 25, Zabaleta et al. discloses wherein the platform is asymmetric such that the enclosure can be attached in single orientation (“a socket 8 is attached to the garment 10, that is designed in a manner which allows positioning of the assembled device 100 in just one possible way”[0031]; “the stimulator 1 has two flanges 17, 18 (see for example Figure 5A) configured to match corresponding recesses 81, 82 (see for example Figure 1 or Figure 5A) in socket 8… the socket 8 has a recess 83 configured to match a corresponding protrusion 19 in the stimulator 1… the socket 8 has a plurality of landmarks 85 (for example, three landmarks 85 are illustrated) designed to match respective holes 95 made on portion 921 of the electrode 9A, 9B, in order to guarantee the correct positioning of the electrode 9A, 9B on the socket 8” [0049]).
Regarding claim 26, Zabaleta et al. discloses wherein a first shape of the enclosure of the wearable neurostimulation device engages with a second shape of the band when the enclosure is secured to the band (fig. 1a; “the garment 10, such as textile or fabric garment, defines a hollow area 60 of substantially the same size and shape as the socket 8. The hollow area is designed to receive the socket 8…the socket 8 shows up through the hollow area 60 of the garment 10, leaving the socket 8 ready to receive the stimulator 1” [0035]).
Claim(s) 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani et al. (US 2013/0158627) in view of Wong et al. (US 2018/0169400) and further in view of Wong et al. (US 2019/0134393; hereinafter Wong et al. ‘393).
Regarding claims 27 and 28, Gozani et al. does not expressly disclose wherein the at least one electrode for each nerve to be stimulated comprises a first electrode configured to stimulate a median nerve and a second electrode configured to stimulate the radial nerve and a third electrode configured to stimulate the ulnar nerve. Wong et al. ‘393 teaches a similar band (fig. 1a-c) comprising a platform for attaching to a wearable neurostimulation device 12 and an electrode system 16 comprising electrodes for targeting individual nerves, and teaches it is known in the art for a first electrode 302 to target a median nerve, a second electrode 304 to target a radial nerve, and a third electrode (“yet another electrode (not shown)”) to target an ulnar nerve ([0070]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gozani et al. to configure the electrode system to comprise three electrodes including a first electrode configured to stimulate a median nerve and a second electrode configured to stimulate the radial nerve and a third electrode configured to stimulate the ulnar nerve as taught by Wong et al. ‘393 as these nerves are known targets within the wrist for delivering stimulation via electrodes, such a modification being reasonably predictable.
Claim(s) 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zabaleta et al. (EP 3,650,077) in view of Wong et al. (US 2018/0169400) and further in view of Wong et al. (US 2019/0134393; hereinafter Wong et al. ‘393).
Regarding claims 27 and 28, Zabaleta et al. does not expressly disclose wherein the at least one electrode for each nerve to be stimulated comprises a first electrode configured to stimulate a median nerve and a second electrode configured to stimulate the radial nerve and a third electrode configured to stimulate the ulnar nerve. Wong et al. ‘393 teaches a similar band (fig. 1a-c) comprising a platform for attaching to a wearable neurostimulation device 12 and an electrode system 16 comprising electrodes for targeting individual nerves, and teaches it is known in the art for a first electrode 302 to target a median nerve, a second electrode 304 to target a radial nerve, and a third electrode (“yet another electrode (not shown)”) to target an ulnar nerve ([0070]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zabaleta et al. to configure the electrode system to comprise three electrodes including a first electrode configured to stimulate a median nerve and a second electrode configured to stimulate the radial nerve and a third electrode configured to stimulate the ulnar nerve as taught by Wong et al. ‘393 as these nerves are known targets within the wrist for delivering stimulation via electrodes, such a modification being reasonably predictable.
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 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