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
This office action is responsive to the amendment filed on 6/29/2026. As directed by the amendment, the status of the claim(s) are:
Claim(s) 13, 22 has/have been amended;
Claim(s) 1-12, 21 is/are cancelled;
Claim(s) 13-27 is/are presently pending.
Response to Arguments
Applicant argues on p. 4-5 of remarks that secondary reference Hadlock’s teaching of cuff electrode is not combinable/compatible under 103 with primary reference Moss since Moss only teaches direct muscle stimulation. After review, this is not persuasive because Moss teaches it is commonly known within the art to stimulate nerve [0004] “By passing small electrical currents through a nerve or directly to the motor units of a muscle via intramuscular, epimysial, and surface electrodes, neural prostheses can initiate action potentials which in turn trigger the release of chemical neurotransmitters to affect an end organ, such as a muscle. Techniques exist to selectively activate axons of any size or location within a nerve or fascicle, making it possible to preferentially target small sensory fibers or duplicate natural motor unit recruitment in order to minimize fatigue and grade the strength of a stimulated muscular contraction. In addition to exciting the nervous system, the proper current waveform and configuration of electrodes can block nerve conduction and inhibit action potential transmission. Thus, in principle any end organ normally under neural control is a candidate for neural prosthetic control.” Furthermore, Moss teaches (emphasis added) [0023] “the term “electrode” means an operable connection to a muscle or nerve that allows an electrical potential to be recorded or applied. An electrode can be further described by its location—i.e. internal, external or percutaneous; electrical or other recording characteristics—i.e. unipolar, bipolar, laplacian, magnetic or optical; and with respect to internal electrodes by its placement—i.e. intramuscular, epimysial, or nerve,”. Finally, it would be inherent that stimulating the muscle motor units as done in Moss [0037] “electrical pulses adapted to be applied to the muscle via an electrode to cause the muscle motor units to contract thereby eliciting a functional motion of the otherwise paralyzed muscle”; results in stimulating the nerve. See also Wikipedia Motor unit (https://en.wikipedia.org/wiki/Motor_unit) “a motor unit is made up of a motor neuron and all of the skeletal muscle fibers innervated by the neuron's axon terminals, including the neuromuscular junctions between the neuron and the fibres.[1] Groups of motor units often work together as a motor pool to coordinate the contractions of a single muscle.” Thus, primary reference Moss teaches stimulating nerves and so Hadlock’s teaching of using a nerve cuff to stimulate nerves would be obvious to combine for the benefits as taught by the combination of references and explained below regarding claim 1.
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 22 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.
Claim 22 recites “The method according to claim 1”; however, claim 1 has been cancelled; thus making the instant claim indefinite. For examination purposes below, it will be assumed that claim 22 depends from independent claim 13.
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) 13-20, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moss (US 20200238082 A1; 7/30/2020; cited in IDS; cited in previous office action) in view of Hadlock (US 20190022383 A1; 1/24/2019; cited in previous office action).
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]).
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 14, in the combination of Moss and Hadlock, 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, in the combination of Moss and Hadlock, 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, in the combination of Moss and Hadlock, 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, in the combination of Moss and Hadlock, 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, in the combination of Moss and Hadlock, Moss teaches wherein the patch electrode is wirelessly connected to the external component of the pulse generator ([0026]; [0074] “inductive link”).
Regarding claim 19, in the combination of Moss and Hadlock, 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, in the combination of Moss and Hadlock, Moss teaches wherein the stimulation signal is at least partially analog ([0027] “continuous waveform”; [0036] “graduated response”; [0059] “analog command signal”).
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”). 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.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moss and Hadlock as applied to claim 13 above, and further in view of Pivonka (US 20200398058 A1; 12/24/2020; issued patent US 11331493 B2 cited in IDS; cited in previous office action).
Regarding claim 23, the combination of Moss and Hadlock 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 and Hadlock 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 and Hadlock as applied to claim 13 above, and further in view of Lineaweaver (US 20110060383 A1; 3/10/2011; cited in previous office action).
Regarding claim 24, the combination of Moss and Hadlock 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 and Hadlock 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 and Hadlock as applied to claim 13 above, and further in view of Nirenberg (US 20160193464 A1; 7/7/2016; cited in previous office action).
Regarding claim 25, the combination of Moss and Hadlock 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 and Hadlock 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, the combination of Moss and Hadlock 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 and Hadlock 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 and Hadlock as applied to claim 13 above, in view of Caban (US 20200147382 A1; 5/14/2020; cited in previous office action).
Regarding claim 27, the combination of Moss and Hadlock 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 and Hadlock 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.
Aszmann (US 20190224479 A1) teaches cuff electrodes to stimulate muscle flexion ([0010]).
Branemark (US 20190254782 A1) teaches cuff electrode for controlling artificial limb with electrodes in biceps and cuff electrodes ([0006]).
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 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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