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 .
Claim Interpretation
Claims 1 and 11 recite the limitations, “for reduction of tremor of a user” and “wherein the electrical stimulation is configured to reduce the tremor of the user”. This limitation is regarded as reciting purpose or intended use that does not result in a manipulative difference between the claimed invention and the prior art and therefore does not serve to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963). When the prior art device is the same as the device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).
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, 3, 6-7, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nathan et al. (US 2011/0152968) in view of Mernoe et al. (US 2013/0046276).
Regarding claim 1, Nathan et al. discloses a separable housing 46, the housing comprising: a generator, wherein the generator 226 (fig. 11) is configured to provide electrical stimulation ([0127]), wherein the electrical stimulation is configured to stimulate one or more nerves of the user ([0092]); and wherein the electrical stimulation is configured to provided to one or more electrodes 94 positioned in contact with a skin surface (fig. 9b) above at least one of the one or more nerves ([0092], [0118]); a power supply 222 comprising a rechargeable battery 220 (fig. 11); and one or more indicators to communicate with the user and report on a stimulation status ([0132]), wherein the housing is configured to be attached to a wearable interface 50 (fig. 1), wherein at least a portion of the wearable interface is separable from the housing (fig. 7), wherein at least a portion 118 of the wearable interface is disposable (“Detachable layer 118 is preferably disposable.” [0141]), wherein the wearable interface comprises at least one band that is configured to at least partially wrap around the wrist of the user (“straps 34a and 34b wrap circumferentially around the limb segment” [0094]; though Fig. 6 shows wearable interface wrapped around the leg of the user, it is also capable of wrapping around a smaller limb such as the wrist of the user). Nathan et al. does not expressly disclose wherein the electrical stimulation is configured to reduce the tremor of the user but given the prior art teaches the stimulation is designed to provide treatment to the neuromuscular system that can impede proper limb functioning such as the hands or legs ([0002-0003]), the electrodes configured to be positioned to stimulate one or more nerves ([0092]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the generator would be capable of being configured to deliver electrical stimulation signals for reducing the tremor of the user as it is a matter of intended use (see claim interpretation above), there being no distinguishable difference between the structure of the currently claimed apparatus and the prior art.
Nathan et al. does not expressly disclose wherein the housing is configured to be attached to the wearable interface via one or more magnets. Instead, Nathan et al. discloses connectors 66, 70 that mechanically attach (“female snap… corresponding male snap”) the housing to the wearable interface ([0112]). Mernoe et al. teaches a snap-fit connector or surface protrusion that mates with female cavities is an equivalent structure to a magnetic connector when joining structures ([0062]) such as a device 300 that is intended to mate with another device 390 (fig. 5-6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nathan et al. and substitute a magnetic connector for the female and male snap connectors as Mernoe et al. teaches both mechanical connector means are art-recognized equivalents at the time the invention was made, such a modification being reasonably predictable and would not alter the overall operation of the device.
Regarding claim 3, the limitation, “wherein the one or more nerves comprise at least one of a median nerve, an ulnar nerve, or a radial nerve” is directed to intended use and does not impart limitations to the structure of the claim. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).
Regarding claim 6, Nathan et al. discloses wherein the wearable interface comprises an electrode interface comprising the one or more electrodes (“electrode assemblies” [0124]).
Regarding claim 7, Nathan et al. discloses a processor 230 configured to control the generator ([0127]).
Regarding claim 10, Nathan et al. discloses the wearable interface comprises at least a portion of a wristband (“straps 34a and 34b wrap circumferentially around the limb segment” [0094]; though Fig. 6 shows wearable interface wrapped around the leg of the user, it is also capable of wrapping around a smaller limb such as the wrist of the user).
Claim(s) 2, 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nathan et al. (US 2011/0152968) in view of Mernoe et al. (US 2013/0046276) and further in view of Ivorra et al. (US 2011/0040204).
Regarding claim 2, Nathan et al. discloses wherein the wearable interface comprises an electrode interface comprising the one or more electrodes 90 (“electrode assemblies” [0124]); and wherein the one or more electrodes comprises a plurality of electrodes 94 (fig. 10); but does not expressly disclose the housing comprises the one or more motion sensors configured to obtain data indicative of one or more characteristics of the tremor of the user. Ivorra et al. teaches an analogous device for electrical stimulation ([0035]) where the device is wrapped around a limb of a user and where the housing 20 of the device comprises a movement sensor 5 (fig. 5) to detect angular and speed of movements ([0031]) in order to determine the quality of the movement ([0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nathan et al. to incorporate movement sensors within the housing of the device as taught by Ivorra et al. in order to provide a feedback sensor that can determine the quality of the tremor (regarded as a type of movement) provided by the user resulting from the electrical stimulation.
Regarding claim 4, Nathan et al. does not expressly disclose the housing comprises the one or more motion sensors configured to obtain data indicative of one or more characteristics of the tremor of the user. Ivorra et al. teaches an analogous device for electrical stimulation ([0035]) where the device is wrapped around a limb of a user and where the housing 20 of the device comprises a movement sensor 5 (fig. 5) to detect angular and speed of movements ([0031]) in order to determine the quality of the movement ([0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nathan et al. to incorporate movement sensors within the housing of the device as taught by Ivorra et al. in order to provide a feedback sensor that can determine the quality of the tremor (regarded as a type of movement) provided by the user resulting from the electrical stimulation.
Regarding claim 5, Nathan et al. discloses the housing is configured to transmit data to an external computing device (“control unit” [0129]).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nathan et al. (US 2011/0152968) in view of Mernoe et al. (US 2013/0046276) and further in view of Peterson et al. (US 2013/0150918).
Regarding claim 8, Nathan et al. does not expressly disclose the processor is configured to apply a stimulation algorithm to adjust one or more stimulation parameters. Peterson et al. teaches it is known in the art for a neurostimulation device processor 74 (fig. 4) to adjust one or more stimulation parameters ([0061]) by applying a stimulation algorithm (“stimulation adjustment algorithm in the IPG 14” [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 Nathan et al. to use a stimulation algorithm to adjust one or more stimulation parameters as taught by Peterson et al. in order for the user to “need not have to manually adjust the stimulation energy in response to a change in the therapeutic environment” ([0072]).
Regarding claim 9, Nathan et al. does not expressly disclose wherein the stimulation algorithm comprises a learning algorithm to tailor stimulation over time to adjust in real-time to the tremor of the user. Peterson et al. teaches the stimulation algorithm comprises a learning algorithm (“continuous training algorithm”) to tailor stimulation over time to adjust in real-time to the needs of the user ([0083]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nathan et al. to use the learning algorithm as taught by Peterson et al. to tailor stimulation over time to adjust in real-time to the user movement sensed by the device in order to allow for the algorithm to be applicable to every therapeutic environment ([0083]).
Claim(s) 11-17, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nathan et al. (US 2011/0152968) in view of Ivorra et al. (US 2011/0040204).
Regarding claim 11, Nathan et al. discloses a separable housing 46, the housing comprising: a generator, wherein the generator 226 (fig. 11) is configured to provide electrical stimulation ([0127]), wherein the electrical stimulation is configured to stimulate one or more nerves of the user ([0092]); a power supply 222 (fig. 11); wherein the housing is configured to be attached to a wearable interface 50 (fig. 1) via at least one of a mechanical, magnetic or adhesive connection (“female snap… corresponding male snap” [0112]), wherein at least a portion of the wearable interface is separable from the housing (fig. 7). Nathan et al. does not expressly disclose wherein the electrical stimulation is configured to reduce the tremor of the user but given the prior art teaches the stimulation is designed to provide treatment to the neuromuscular system that can impede proper limb functioning such as the hands or legs ([0002-0003]), the electrodes configured to be positioned to stimulate one or more nerves ([0092]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the generator would be capable of being configured to deliver electrical stimulation signals for reducing the tremor of the user as it is a matter of intended use (see claim interpretation above), there being no distinguishable difference between the structure of the currently claimed apparatus and the prior art.
Nathan et al. does not expressly disclose the housing comprises the one or more motion sensors configured to obtain data indicative of one or more characteristics of the tremor of the user. Ivorra et al. teaches an analogous device for electrical stimulation ([0035]) where the device is wrapped around a limb of a user and where the housing 20 of the device comprises a movement sensor 5 (fig. 5) to detect angular and speed of movements ([0031]) in order to determine the quality of the movement ([0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nathan et al. to incorporate movement sensors within the housing of the device as taught by Ivorra et al. in order to provide a feedback sensor that can determine the quality of the tremor (regarded as a type of movement) provided by the user resulting from the electrical stimulation.
Regarding claim 12, Nathan et al. discloses one or more indicators to communicate with the user and report on a status of the electrical stimulation ([0132]), wherein the wearable interface comprises an electrode interface comprising the one or more electrodes 90 (“electrode assemblies” [0124]), wherein the wearable interface comprises at least one band that is configured to at least partially wrap around the wrist of the user (“straps 34a and 34b wrap circumferentially around the limb segment” [0094]; though Fig. 6 shows wearable interface wrapped around the leg of the user, it is also capable of wrapping around a smaller limb such as the wrist of the user).
Regarding claim 13, Nathan et al. discloses the power supply 222 comprising a rechargeable battery 220 (fig. 11), wherein the wearable interface comprises at least one band that is configured to at least partially wrap around the wrist of the user (“straps 34a and 34b wrap circumferentially around the limb segment” [0094]; though Fig. 6 shows wearable interface wrapped around the leg of the user, it is also capable of wrapping around a smaller limb such as the wrist of the user), wherein the wearable interface comprises an electrode interface comprising the one or more electrodes 90 (“electrode assemblies” [0124]); and wherein the one or more electrodes comprises a plurality of electrodes 94 (fig. 10).
Regarding claim 14, the limitation, “wherein the one or more nerves comprise at least one of a median nerve, an ulnar nerve, or a radial nerve” is directed to intended use and does not impart limitations to the structure of the claim. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).
Regarding claim 15, Nathan et al. discloses the housing is configured to transmit data to an external computing device (“control unit” [0129]).
Regarding claim 16, Nathan et al. discloses wherein the wearable interface comprises an electrode interface comprising the one or more electrodes 90 (“electrode assemblies” [0124]).
Regarding claim 17, Nathan et al. discloses a processor 230 configured to control the generator ([0127]).
Regarding claim 20, Nathan et al. discloses the wearable interface comprises at least a portion of a wristband (“straps 34a and 34b wrap circumferentially around the limb segment” [0094]; though Fig. 6 shows wearable interface wrapped around the leg of the user, it is also capable of wrapping around a smaller limb such as the wrist of the user).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nathan et al. (US 2011/0152968) in view of Ivorra et al. (US 2011/0040204) and further in view of Peterson et al. (US 2013/0150918).
Regarding claim 18, Nathan et al. does not expressly disclose the processor is configured to apply a stimulation algorithm to adjust one or more stimulation parameters. Peterson et al. teaches it is known in the art for a neurostimulation device processor 74 (fig. 4) to adjust one or more stimulation parameters ([0061]) by applying a stimulation algorithm (“stimulation adjustment algorithm in the IPG 14” [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 Nathan et al. to use a stimulation algorithm to adjust one or more stimulation parameters as taught by Peterson et al. in order for the user to “need not have to manually adjust the stimulation energy in response to a change in the therapeutic environment” ([0072]).
Regarding claim 19, Nathan et al. does not expressly disclose wherein the stimulation algorithm comprises a learning algorithm to tailor stimulation over time to adjust in real-time to the tremor of the user. Peterson et al. teaches the stimulation algorithm comprises a learning algorithm (“continuous training algorithm”) to tailor stimulation over time to adjust in real-time to the needs of the user ([0083]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nathan et al. to use the learning algorithm as taught by Peterson et al. to tailor stimulation over time to adjust in real-time to the user movement sensed by the device in order to allow for the algorithm to be applicable to every therapeutic environment ([0083]).
Conclusion
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