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 March 26, 2026 has been entered. Claims 1, 5-6, 9-11, 15 and 19 have been amended. Currently, claims 1-20 are pending for examination.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Interpretation
Claim 1 is directed to a “separable housing” comprising the generator, the power supply, and the indicators as required. While the claim also recites limitations directed to a wearable interface, this wearable interface is not positively recited by claim 1 and for purposes of patentability, need not be considered. However to promote compact prosecution, a prior art rejection considering the limitations of the wearable interface is provided below.
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) 1-9, 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gesotti (US 6,704,603) in view of Wheeler (US 2006/0047326) and Dar et al. (US 9,095,417).
Regarding claim 1, Gesotti discloses a separable housing 120 configured for reduction of tremor of a user, the housing comprising: a generator 121; wherein the generator is configured to provide electrical stimulation (col. 4, lines 51-55), wherein the electrical stimulation is configured to reduce the tremor of the user (col. 2, lines 13-16; col. 2, lines 39-50), wherein the electrical stimulation is configured to be provided to one or more electrodes 130 positioned in contact with a skin surface (col. 3, line 55 to col. 4, line 13); one or more indicators 132 to communicate with the user and report on a stimulation status (col. 4, lines 21-34), wherein the housing is configured to be attached to a wearable interface (fig. 10), wherein at least a portion of the wearable interface is separable from the housing (“In one embodiment, the electrical leads 1046-1 and 1046-2 couple to a common wire connector such as the wire connector 919 of FIG. 9. In another embodiment, the electrical leads 1046-1 and 1046-2 are directly coupled to a control unit such as control unit 120 discussed with respect to FIG. 1.” col. 9, lines 40-44), wherein at least a portion of the wearable interface is capable of being disposable, wherein the wearable interface comprises at least one band that is configured to at least partially wrap around a wrist of the user (col. 9, lines 29-30), wherein the housing is non-invasive.
Gesotti does not expressly disclose wherein the electrical stimulation is configured to stimulate one or more nerves of the user sufficient to reduce the tremor of the user and has a frequency greater than 15 Hz. Wheeler teaches delivering electrical stimulation to nerves of a user at a frequency greater than 15 Hz (“approximately 25 kHz” [0034]) to reduce Parkinson’s disease tremor ([0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gesotti and try using an electrical stimulation frequency greater than 15 Hz as taught by Wheeler as the prior art teaches it is a known frequency sufficient to reduce the tremor of a user, the results of such a modification being reasonably predictable.
Gesotti does not expressly disclose the housing comprises a power supply comprising a rechargeable battery. Dar et al. teaches it is known in the art for a stimulator housing to comprise a power supply comprising a rechargeable battery for powering the stimulator (col. 11, lines 37-38). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gesotti to include a power supply comprising a rechargeable battery as taught by Dar et al. as it is a known feature for powering similar devices, would not alter the overall operation of the device and the results of such a modification would have been reasonably predictable.
Gesotti does not expressly disclose wherein the housing is configured to be attached to the wearable interface via one or more magnets, snapping features, or pressfit features. Dar et al. teaches it is known in the art for a stimulator housing 202 to be attached to a wearable interface 220 (fig. 2) via snapping features or pressfit features (col. 11, lines 25-31). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gesotti to attach the housing to the wearable device via snapping features or pressfit features as taught by Dar et al. in order to minimize wires extending between the wearable interface and the housing that could tangle or snag, such an attachment feature known in the art, would not alter the overall operation of the device and the results of such a modification would have been reasonably predictable.
Regarding claim 2, Gesotti discloses wherein the housing further comprises one or more motion sensors 110 (col. 3, lines 57-60) configured to obtain data indicative of one or more characteristics of the tremor of the user, wherein the wearable interface comprises an electrode interface comprising the one or more electrodes 1044-1, 1044-2 (fig. 10).
Regarding claim 3, Gesotti does not expressly disclose wherein the one or more nerves comprise at least one of a median nerve, an ulnar nerve, or a radial nerve. Wheeler teaches reducing tremor ([0033]) by specifically stimulating the median nerve ([0052]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gesotti to stimulate the median nerve as taught by Wheeler as it is a known nerve to stimulate to reduce tremors.
Regarding claim 4, Gesotti discloses wherein the housing further comprises one or more motion sensors 110 (col. 3, lines 57-60) configured to obtain data indicative of one or more characteristics of the tremor of the user.
Regarding claim 5, Gesotti discloses wherein the housing is configured to wirelessly transmit the data to an external computing device 109 (fig. 1), and wherein the external computing device comprises a smartphone or tablet computing device (col. 4, line 65 to col. 5, line 20).
Regarding claim 6, Gesotti discloses wherein the wearable interface comprises an electrode interface comprising the one or more electrodes 1044-1, 1044-2 (fig. 10) but does not expressly disclose wherein the one or more electrodes are configured to contact the skin surface above at least one of a median nerve, an ulnar nerve, or a radial nerve. Wheeler teaches reducing tremor ([0033]) by specifically stimulating the median nerve ([0052]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gesotti to stimulate the median nerve as taught by Wheeler as it is a known nerve to stimulate to reduce tremors.
Regarding claim 7, Gesotti discloses a processor 122 configured to control the generator 121 (fig. 1; col. 4, lines 35-64).
Regarding claim 8, Gesotti discloses wherein the processor is configured to apply a stimulation algorithm to adjust one or more stimulation parameters (col. 4, lines 35-64).
Regarding claim 9, Gesotti discloses wherein the stimulation algorithm comprises a learning algorithm to tailor stimulation over time to adjust in real-time or periodically to the tremor of the user (“Control unit 120 selectively adjusts stimulation voltage, frequency, pulse width, waveform shape, amplitude, modulation type and the like of each electrical stimulation signal based on sensor information.” col. 4, lines 10-14; “In one embodiment, control unit 120 includes a controller 122 that receives information from sensors 110. Controller 122 includes software that includes algorithms for processing the information from input signals and determines the response(s) required to produce simulation and stimulation.” col. 4, lines 35-39).
Regarding claim 11, Gesotti discloses a separable housing 120 configured for reduction of tremor of a user, the housing comprising: a generator 121; wherein the generator is configured to provide electrical stimulation (col. 4, lines 51-55), wherein the electrical stimulation is configured to reduce the tremor of the user (col. 2, lines 13-16; col. 2, lines 39-50), one or more motion sensors 110 (col. 3, lines 57-60) configured to obtain data indicative of one or more characteristics of the tremor of the user, wherein the housing is configured to be attached to a wearable interface (fig. 10), wherein at least a portion of the wearable interface is separable from the housing (“In one embodiment, the electrical leads 1046-1 and 1046-2 couple to a common wire connector such as the wire connector 919 of FIG. 9. In another embodiment, the electrical leads 1046-1 and 1046-2 are directly coupled to a control unit such as control unit 120 discussed with respect to FIG. 1.” col. 9, lines 40-44), and wherein the housing is non-invasive.
Gesotti does not expressly disclose wherein the electrical stimulation is configured to stimulate one or more nerves of the user sufficient to reduce the tremor of the user and has a frequency greater than 15 Hz. Wheeler teaches delivering electrical stimulation to nerves of a user at a frequency greater than 15 Hz (“approximately 25 kHz” [0034]) to reduce Parkinson’s disease tremor ([0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gesotti and try using an electrical stimulation frequency greater than 15 Hz as taught by Wheeler as the prior art teaches it is a known frequency sufficient to reduce the tremor of a user, the results of such a modification being reasonably predictable.
Gesotti does not expressly disclose the housing comprises a power supply. Dar et al. teaches it is known in the art for a stimulator housing to comprise a power supply comprising a rechargeable battery for powering the stimulator (col. 11, lines 37-38). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gesotti to include a power supply comprising a rechargeable battery as taught by Dar et al. as it is a known feature for powering similar devices, would not alter the overall operation of the device and the results of such a modification would have been reasonably predictable.
Gesotti does not expressly disclose wherein the housing is configured to be attached to the wearable interface via at least one of a mechanical, magnetic or adhesive connection. Dar et al. teaches it is known in the art for a stimulator housing 202 to be attached to a wearable interface 220 (fig. 2) via mechanical snapping features or pressfit features (col. 11, lines 25-31). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gesotti to attach the housing to the wearable device via snapping features or pressfit features as taught by Dar et al. in order to minimize wires extending between the wearable interface and the housing that could tangle or snag, such an attachment feature known in the art, would not alter the overall operation of the device and the results of such a modification would have been reasonably predictable.
Regarding claim 12, Gesotti discloses wherein the housing further comprises one or more indicators 132 to communicate with the user and report on a stimulation status (col. 4, lines 21-34), wherein the wearable interface comprises an electrode interface comprising one or more electrodes 1044-1, 1044-2 (fig. 10), wherein the wearable interface comprises at least one band that is configured to at least partially wrap around a wrist of the user (col. 9, lines 29-30), and wherein the generator is configured to provide the electrical stimulation to the one or more electrodes (col. 3, line 55 to col. 4, line 13).
Regarding claim 13, Gesotti in view of Dar et al. disclose wherein the power supply comprises a rechargeable battery (see claim 11 above), wherein the wearable interface comprises at least one band that is configured to at least partially wrap around a wrist of the user (col. 9, lines 29-30), wherein the wearable interface comprises an electrode interface comprising one or more electrodes 1044-1, 1044-2 (fig. 10), and wherein the one or more electrodes comprises a plurality of electrodes (fig. 10).
Regarding claim 14, Gesotti does not expressly disclose wherein the one or more nerves comprise at least one of a median nerve, an ulnar nerve, or a radial nerve. Wheeler teaches reducing tremor ([0033]) by specifically stimulating the median nerve ([0052]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gesotti to stimulate the median nerve as taught by Wheeler as it is a known nerve to stimulate to reduce tremors.
Regarding claim 15, Gesotti discloses wherein the housing is configured to wirelessly transmit the data to an external computing device 109 (fig. 1), and wherein the external computing device comprises a smartphone or tablet computing device (col. 4, line 65 to col. 5, line 20).
Regarding claim 16, Gesotti discloses wherein the wearable interface comprises an electrode interface comprising one or more electrodes 1044-1, 1044-2 (fig. 10).
Regarding claim 17, Gesotti discloses a processor 122 configured to control the generator 121 (fig. 1; col. 4, lines 35-64).
Regarding claim 18, Gesotti discloses wherein the processor is configured to apply a stimulation algorithm to adjust one or more stimulation parameters (col. 4, lines 35-64).
Regarding claim 19, Gesotti discloses wherein the stimulation algorithm comprises a learning algorithm to tailor stimulation over time to adjust in real-time or periodically to the tremor of the user (“Control unit 120 selectively adjusts stimulation voltage, frequency, pulse width, waveform shape, amplitude, modulation type and the like of each electrical stimulation signal based on sensor information.” col. 4, lines 10-14; “In one embodiment, control unit 120 includes a controller 122 that receives information from sensors 110. Controller 122 includes software that includes algorithms for processing the information from input signals and determines the response(s) required to produce simulation and stimulation.” col. 4, lines 35-39).
Regarding claim 20, Gesotti discloses wherein the wearable interface comprises at least a portion of a wristband (col. 9, lines 29-54).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gesotti (US 6,704,603) in view of Wheeler (US 2006/0047326) and Dar et al. (US 9,095,417) and further in view of Boston (US 2007/0123951).
Regarding claim 10, Gesotti does not expressly disclose wherein the housing is configured to be attached to a portion of the wearable interface via one or more magnets. Boston teaches a device for reducing tremor, comprising a wearable interface 1 and a stimulation housing 27, where magnets are used to attach the stimulation housing to the wearable interface ([0053]) in order to “simplify insertion and orientation” of the stimulation housing ([0053]) and to enable the stimulation housing to be “placed roughly in the region of the insertion portion since the magnets 39 will then complete the positioning process and fix the control unit 27 accurately in place, such that the control unit 27 may be easily slid into the insertion portal 47 even in the presence of severe body tremors by the patient” ([0054]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gesotti to use magnets to attach the housing to a portion of the wearable interface as taught by Boston in order to simplify the attachment and orientation of the housing to the wearable interface ([0053-0054]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Prochazka et al. (US 5,562,707).
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.
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 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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