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 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.
Claim(s) 13-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moss (US 20200238082 A1; 7/30/2020; cited in IDS).
Regarding claim 13, Moss teaches a method for inducing flexion in a target muscle of a patient (Fig. 1-2; Fig. 4; Fig. 5), said method comprising:
externally generating a drive signal (Fig. 1-2; Fig. 4; Fig. 5; [0011]; [0077]);
receiving the drive signal in an external component of a pulse generator (Fig. 1-2; Fig. 4; Fig. 5; [0011]; [0077]-[0078]);
wirelessly transmitting a stimulation signal generated by the external component in response to the drive signal to a subcutaneously implanted internal component of the pulse generator (Fig. 1-2; Fig. 4; Fig. 5; [0046] “wireless”; [0074] “inductive link”); and
delivering a stimulation current produced by the implanted internal component of the pulse generator to a motor nerve that innervates the target muscle to induce motion of said muscle (Fig. 1-2; Fig. 4; Fig. 5; [0011]; [0046] “cause the biceps muscle 202 to contract”; [0037]; [0077]).
Regarding claim 14, Moss teaches wherein the drive signal is a flexion signal generated in response to an electromyography (EMG) signal characteristic of attempted flexion of the target muscle (Fig. 1; [0007] “myoelectric signals”; [0022] “myoelectric”; [0040] “volitional electrical signal; [0046]-[0047]; [0065] “surface EMG recording electrodes”; [0077]-[0078]).
Regarding claim 15, Moss teaches wherein the target muscle comprises a patient's biceps muscle (Fig. 2; Fig. 4; [0040] “biceps”; [0046] “cause the biceps muscle 202 to contract”).
Regarding claim 16, Moss teaches wherein the flexion signal is produced by a patch electrode located over the target muscle at a position distal to an electrode which delivers the stimulation current to the target muscle (Fig. 2, 204 reads on patch electrode and 234 reads on electrode which delivers stimulation; [0046]; Fig. 5, 502 reads on patch electrode and 504 reads on electrode which delivers stimulation; [0079]; [0065] “surface EMG recording electrodes”).
Regarding claim 17, Moss teaches wherein the patch electrode is wired to the external component of the pulse generator (Fig. 2; Fig. 5; [0026]; [0040] “conductive wire”).
Regarding claim 18, Moss teaches wherein the patch electrode is wirelessly connected to the external component of the pulse generator ([0026]; [0074] “inductive link”).
Regarding claim 19, Moss teaches wherein the stimulation signal is at least partially digital ([0027] “discrete value(s)”; [0033]-[0034]; [0036] “binary, on/off command”; [0044] “digital volitional signal…on/off or logical signal…exceeded a threshold value (i.e. a logical state change”; [0069]; the reference is teaching that the incoming signal is digitized and the resulting stimulation signal is based upon whether the threshold for changing logical state of on/off is triggered, therefore the resulting stimulation signal is “at least partially digital”).
Regarding claim 20, Moss teaches wherein the stimulation signal is at least partially analog ([0027] “continuous waveform”; [0036] “graduated response”; [0059] “analog command signal”).
Claim Rejections - 35 USC § 103
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) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moss as applied to claim 13 above, in view of Hadlock (US 20190022383 A1; 1/24/2019).
Regarding claim 21, Moss does not teach wherein the stimulation current is delivered to the motor nerve by a cuff electrode wrapped around the motor nerve. However, Hadlock teaches in the same field of endeavor (Abstract; Fig. 13-14; [0008]) wherein the stimulation current is delivered to the motor nerve by a cuff electrode wrapped around the motor nerve ([0045]-[0046]; [0059] “”neural cuff electrodes (NCEs) (Microprobes for Life Sciences,”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moss to include this feature as taught by Hadlock because neural cuff electrodes provide intimate contact with nerve ([0045]-[0046]) and are suitable for stimulation of motor nerves; MPEP 2144.07 art recognized suitability for an intended purpose.
Regarding claim 22, the combination of Moss and Hadlock teaches wherein the cuff electrode is subcutaneously wired to the implanted component of the pulse generator (Moss Fig. 4; [0074] “multiple stimulating electrodes 402 that are operably connected to an implanted recording stimulator”; Hadlock [0053] “leads connected to the signal generator”).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moss as applied to claim 13 above, in view of Pivonka (US 20200398058 A1; 12/24/2020; issued patent US 11331493 B2 cited in IDS).
Regarding claim 23, Moss does not teach further comprising inductively recharging a battery in the implantable component of the pulse generator using a power supply in the external component. Note that Moss teaches inductive coupling of external component to implantable component of pulse generator ([0074] “inductive link”). However, Pivonka teaches in the same field of endeavor (Fig. 1; [0026]) inductively recharging a battery in the implantable component of the pulse generator using a power supply in the external component ([0532]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moss to include these features as taught by Pivonka because this enables power supply for if/when external device is unavailable ([0532]).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moss as applied to claim 13 above, in view of Lineaweaver (US 20110060383 A1; 3/10/2011).
Regarding claim 24, Moss does not teach further comprising magnetically securing the external component of the pulse generator over the implanted component of the pulse generator. However, Lineaweaver teaches in the same field of endeavor (Fig. 1-2; [0003]) magnetically securing the external component of the pulse generator over the implanted component of the pulse generator (Fig. 1, magnet 110 secures to magnet 140; [0024]-[0025]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moss to include this feature as taught by Lineaweaver because this enables securing and aligning of external component to internal component (Fig. 1; [0024]-[0025]).
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moss as applied to claim 13 above, in view of Nirenberg (US 20160193464 A1; 7/7/2016).
Regarding claim 25, Moss does not teach wherein the drive signal has a current in a range from 0.1 mA to 20 mA. Note that Moss teaches adapting and mapping control signal from user in order to achieve the appropriate result (Fig. 6; [0040]; [0054]; [0059]; [0080]). However, Nirenberg teaches in the same field of endeavor (Abstract; [0003]; [0005]) wherein the drive signal has a current in a range from 0.1 mA to 20 mA ([0139] “about 10 mA”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moss to include this feature as taught by Nirenberg because this is a suitable current to use ([0139]); In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.
Regarding claim 26, Moss does not teach wherein the drive signal has a repetition in a range from 1 pulses per sec to 50 pulses per sec. Note that Moss teaches adapting and mapping control signal from user in order to achieve the appropriate result (Fig. 6; [0040]; [0054]; [0059]; [0080]), specifically teaching 10 Hz to 1 kHz ([0080]) which would overlap the recited range. However, Nirenberg teaches in the same field of endeavor (Abstract; [0003]; [0005]) wherein the drive signal has a repetition in a range from 1 pulses per sec to 50 pulses per sec. ([0139] “50 Hz” reads on 50 pulses per sec.). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moss to include this feature as taught by Nirenberg because this is a suitable parameter to use ([0139]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moss as applied to claim 13 above, in view of Caban (US 20200147382 A1; 5/14/2020).
Regarding claim 27, Moss does not teach wherein the drive signal has a current in a duration in a range from 10 µs to 200 µs. Note that Moss teaches adapting and mapping control signal from user in order to achieve the appropriate result (Fig. 6; [0040]; [0054]; [0059]; [0080]). However, Caban teaches in the same field of endeavor (Abstract; Fig. 11; [0013]) wherein the drive signal has a current in a duration in a range from 10 µs to 200 µs ([0149] “200 µs”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moss to include this feature as taught by Caban because this is a suitable parameter to use ([0149]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Casse (US 20180353766 A1; 12/13/2018) teaches in [0141] “The duration of the current pulse may be about 100 to about 200 μs in some embodiments.”). This is relevant to claim 27.
Glass (US 20230181340 A1; Filed 5/25/2021) teaches neural prosthesis in which EMG is taken to control prosthetic hand (Fig. 10).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
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