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 Arguments
Applicant's arguments filed 7/25/2025 have been fully considered but they are not persuasive. Applicant argues Einarsson only describes control based on EMG signals. This is not persuasive because at least par.146 of Einarsson discloses control may be based on EMG in combination with measurements by inertial sensors, ground force sensors, joint angle sensors, and/or joint moment sensors.
Applicant argues Einarsson describes that co-contractions actually diminish the user’s ability to control the prosthetic and states the user has to learn to manage co-contractions such that the user can control the prosthesis and the system can overcome the noise of co-contractions. This is not persuasive because this discussion in Einarsson (par.119) is related to voluntary contractions and POD control, not involuntary/reflexive muscle co-contraction for detecting and preventing falls. Par.119 of Einarsson is directed to testing for identifying a particular user’s capability of contracting an individual muscle on command for the purpose of determining if EMG singles can be used for control of a POD. The reflexive muscle co-contraction studied in Huang relates to a person’s hard-wired reflex and protective neural control. In other words, applicant’s discussion of the co-contractions discussed in Einarsson is unrelated to the reflexive co-contractions as claimed and as taught by Huang.
Applicant argues the Office is mischaracterizing the teachings of Huang and ignoring the actual disclosure of Huang. Applicant argues Huang does not disclose control of a prosthetic using co-contractions, that the EMG detector of Huang may detect co-contractions but the stumble detection system of Huang does not control the prosthetic based on the detected co-contractions. Applicant argues the stumble detection system of Huang controls the prosthetic based on EMG data that may or may not include co-contractions. These arguments are unclear to the examiner. What would be the point of detecting reflexive co-contractions and then not controlling the prosthetic based on the co-contractions? Huang teaches using the stumble detection system, which includes detecting at least reflexive muscle co-contractions, in order to further improve the safe use of prostheses and to allow computer controlled artificial legs to provide active stumble recovery (par.23). From this teaching, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to use the detected reflexive muscle co-contractions to control the prostheses of Einarsson to provide active stumble recovery.
Applicant argues Huang “also teaches away from the use of co-contractions alone to control a prosthetic” and goes on to explain that Huang prefers at least two detection sources, preferably foot acceleration and EMG. This argument is not persuasive because the claims do not require use of co-contractions alone to control a prosthetic. See at least claim 9 of the application which discloses a sensor detects forces, angles, positions, accelerations and/or moments on the orthotic or prosthetic device and the movement behavior is changed on the basis of the sensor signal. The claims of the application do not preclude two detection sources, and since EMG is one of the two detection sources, Huang teaches the use of detecting at least reflexive muscle co-contraction to control a prosthesis.
In conclusion, the examiner maintains that Einarsson discloses the invention substantially as claimed, namely an orthotic or prosthetic device and a method for controlling an orthotic or prosthetic device as claimed, except that Einarsson does not specifically disclose detecting at least one reflexive muscle co-contraction and changing, with the at least one adjustable actuator, movement behavior based on the at least one reflexive muscle co-contraction, wherein the at least one adjustable actuator provides a movement resistance against pivoting, and the movement resistance is increased when a reflexive muscle co-contraction is detected. Huang teaches using a stumble detection system, which includes detecting reflexive muscle co-contractions, in order to further improve the safe use of prostheses and to allow computer controlled artificial legs to provide active stumble recovery (par.23). While Huang does not specifically state that the movement resistance of an actuator increases when a reflexive muscle co-contraction is detected, Huang does teach the reactive EMG signals are characterized as being high-magnitude and relatively long in duration. Therefore, since Einarsson discloses the relationship between the amplitude of an EMG signal and the impedance (considered the movement resistance) is linear where the impedance is proportional to the amplitude of the EMG signal with a baseline offset (Einarsson par. 143), it would have been further obvious to one of ordinary skill in the art before the effective filing date to apply the same principal with the detected reflexive muscle co-contractions taught by Huang in order to provide proportional control based on the intensity/duration of the reflexive muscle co-contraction. In other words, since Huang teaches that the reflexive muscle co-contractions indicative of a fall or stumble have a high-magnitude (same as amplitude) and long duration, and Einarsson teaches the relationship between the amplitude of the EMG signal and the impedance/resistance is linear and proportional, it would follow that the adjustable actuator of Einarsson in view of Huang provides an increased resistance when a reflexive muscle co-contraction (which would be indicated by a high amplitude as taught by Huang) is detected.
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.
Claims 1, 2, 4 and 6-22 are rejected under 35 U.S.C. 103 as being unpatentable over Einarsson et al. US 2016/0302686 (hereafter referred to as Einarsson) in view of Huang US 2012/0191017 (hereafter referred to as Huang).
Regarding claim 1, Einarsson discloses a method for controlling an orthotic or prosthetic device which can be placed on the body of a user and secured thereon, the orthotic or prosthetic device comprising: a. a joint device 10 (fig.1A) with a proximal component (socket connected to connector 17 as discloses in par.50) and a distal component 20, which are mounted pivotably on each other about a pivot axis (axis through knee joint 11), b. at least one adjustable actuator 12, 316 (figs. 1A and 3; pars.51 and 68), which is arranged between the proximal component and the distal component and via which a movement behavior with respect to a pivoting of the proximal component relative to the distal component is adjustable (par.68 discloses the actuator is electronically adjustable and capable of providing resistance and/or actively moving the joint; par.143 discloses dynamic adjustment), c. at least one detection device for detecting muscle co-contractions (at least pars. 11, 112, 126, 144, and 155 disclose EMG sensors for antagonistic muscles which are capable of detecting muscle co-contraction; see figs.5-7 which show co-contractions of the quadriceps and hamstring muscles), and d. a control device 305 (par.65 discloses the control system can be used for the knee devices) which is coupled to the at least one detection device 302 and to the at least one adjustable actuator 316 (fig.3), wherein the control device processes signals from the at least one detection device, and adjusts the at least one adjustable actuator according to the signals (par.66), the method comprises: arranging the at least one detection device on a limb of the user, coupling the at least one detection device to the control device, detecting, with the at least one detection device, at least one muscle co-contraction, and changing, with the at least one adjustable actuator, the movement behavior (at least par.143 discloses when device measures EMG signals with increased amplitude it can provide higher resistance in response; in order to take the measurements and adjust the actuator, the steps of arranging the detection device (sensors) on a limb of the user, coupling the detection device to the control device, and detecting with the detection device at least one muscle co-contraction inherently must occur). Einarsson shows co-contractions occurring in figs. 5-7. Einarsson also discloses the prosthetic or orthotic device (POD) can identify a stumble and/or slip by the user, and a stumble or slip can be identified by a rapidly changing or erratic EMG signal in par.156. Einarsson discloses the invention substantially as claimed, but Einarsson does not specifically state that the method includes detecting at least one reflexive muscle co-contraction (interpreted as a co-contraction that occurs as a reflex and is involuntary) and changing the movement behavior specifically based on the at least one reflexive muscle co-contraction, wherein the at least one actuator provides a movement resistance against pivoting, and the movement resistance is increased when a reflexive muscle co-contraction is detected.
Huang teaches a method for controlling a POD, in the same field of endeavor, wherein the method includes using a detection device that detects reflexive muscle co-contractions (par.63) and controlling the prosthesis based on the reflexive muscle co-contractions in order to provide amputees with improved control and functionality of the prosthesis by facilitating preventing falls (par.6). Par.65 of Huang teaches co-contraction of muscles in the thigh with high activation levels may accurately indicate the protective neural response to balance disturbances. Par. 33 of Huang teaches “neuromuscular reaction is fast and reliable since it is elicited by hard-wired reflex and protective neural control. Surface EMG signals measured from the residual limbs and gluteal muscles have been reported to react to perturbations despite the side of perturbed limb. The reactive EMG signals are characterized as being high-magnitude and relatively long in duration”. Huang further discloses using the stumble detection system, which includes detecting reflexive muscle co-contractions, in order to further improve the safe use of prostheses and to allow computer controlled artificial legs to provide active stumble recovery (par.23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Einarsson to include the step of detecting reflexive muscle co-contractions as taught by Huang in order to accurately warn the system of an impending stumble. It would have been further obvious to change, with the actuator, the movement behavior, including the movement resistance of the POD of Einarsson based on the at least one reflexive muscle co-contraction since Huang teaches control of a POD based on the stumble detection system, which includes the reflexive muscle co-contraction, in order to prevent falls and improve safety. Since Einarsson discloses the relationship between the amplitude of the EMG signal and the impedance (considered the movement resistance) is linear where the impedance is proportional to the amplitude of the EMG signal with a baseline offset (Einarsson par. 143), it would have been further obvious to one of ordinary skill in the art before the effective filing date to apply the same principal with the detected reflexive muscle co-contractions taught by Huang in order to provide proportional control based on the intensity/duration of the reflexive muscle co-contraction. As such, since the reactive EMG signals (indicative of the reflexive co-contractions) of Huang are characterized as being high-magnitude (high amplitude) and relatively long in duration it would follow that the movement resistance be increased when the reflexive muscle co-contraction is detected in the method of Einarsson in view of Huang.
Regarding claims 2, 4 and 7, Einarsson discloses the relationship between the amplitude of the EMG signal and the impedance (considered the movement resistance) is linear where the impedance is proportional to the amplitude of the EMG signal with a baseline offset. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to apply the same principal with the detected reflexive muscle co-contractions taught by Huang in order to provide proportional control based on the intensity/duration of the reflexive muscle co-contraction. This means increasing co-contraction intensity and/or duration yields increasing movement resistance while decreasing co-contraction intensity and/or duration yields decreasing movement resistance.
Regarding claim 6, see Einarsson pars. 42 and 102 for preset control programs.
Regarding claim 8, see Einarsson par.32 for types of signals including at least myoelectric signals.
Regarding claim 9, see Einarsson par.146 for control based on both EMG signals and other types of sensors which detect forces, angles, positions, accelerations, and/or moments.
Regarding claim 10, see Einarsson par.71 and figs. 3-4 for sensor module 302 (considered a pre-processing unit) pre-processing the EMG signal before transmitting in processed form to the control device 305.
Regarding claim 11, see Einarsson par.84 which discloses checking EMG signals for meeting thresholds to determine if the signals can be relied upon. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the step of checking the reflexive muscle co-contractions of Einarsson in view of Huang in order to ensure they can be relied upon as usable data to control the actuator.
Regarding claim 12, see the rejection of claim 1 above which refers to a POD as claimed in claim 12.
Regarding claim 13, see Einarsson par.31 for surface or implanted EMG sensors.
Regarding claim 14, while Einarsson does not specify that the sensors (considered the at least one detection device) are integrated in the proximal and/or distal component, Huang teaches it is desirable to use sensors that may be integrated into the prosthesis or socket in order to be practical for a transfemoral prosthesis (par.37). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the EMG sensors of Einarsson in view of Huang in the socket (which forms the proximal component of Einarsson) as taught by Huang since Huang teaches this arrangement is desirable for transfemoral prostheses.
Regarding claim 15, see Einarsson par.146 for control based on both EMG signals and other types of sensors which detect forces, angles, positions, accelerations, and/or moments.
Regarding claims 16-18, see Einarsson par.71 and figs. 3-4 for sensor module 302 which includes the at least one detection device (sensors) coupled to a pre-processing unit. This sensor module is considered a common module since it includes both the sensor and pre-processing unit as discussed in par.71. The sensor module 302 is capable of plug and play with the controller as shown in fig.3.
Regarding claim 19, see par.68 of Einarsson for the actuator capable of providing resistance and/or drive (using a motor).
Regarding claim 20, see the rejection of claim 1 above which refers to a POD substantially as claimed in claim 20. Einarsson par.31 further discloses surface or implanted EMG sensors. While Einarsson does not specify that the sensors (considered the at least one detection device) are integrated in the proximal and/or distal component, Huang teaches it is desirable to use sensors that may be integrated into the prosthesis or socket in order to be practical for a transfemoral prosthesis (par.37). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the EMG sensors of Einarsson in view of Huang in the socket (which forms the proximal component of Einarsson) as taught by Huang since Huang teaches this arrangement is desirable for transfemoral prostheses.
Regarding claims 21 and 22, see the rejection of claim 1 above. Einarsson discloses the relationship between the amplitude of the EMG signal and the impedance (considered the movement resistance) is linear where the impedance is proportional to the amplitude of the EMG signal with a baseline offset. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to apply the same principal with the detected reflexive muscle co-contractions taught by Huang in order to provide proportional control based on the intensity/duration of the reflexive muscle co-contraction.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Einarsson in view of Huang as applied to claim 4 above, and further in view of Gregg et al. US 2014/0364962 (hereafter referred to as Gregg). Einarsson in view of Huang discloses the method as claimed in claim 4, but does not disclose wherein the movement resistance is increased more quickly than it is reduced.
Gregg teaches a prosthetic device and teaches a method wherein the movement resistance is increased more quickly than it is reduced (Figs. 8a-b depict the knee torque (resistance) increases more quickly than decreases as stance percent increases).
Therefore, it would have been obvious to one of ordinary skill in the art to have modified the movement resistance of Einarsson in view of Huang to increase quicker than it is reduced as taught by Gregg for the purpose of closely mirroring the natural shape of a sound limb (Gregg: Paragraph 0067). It would have been further obvious for the movement resistance to be increased more quickly than it is reduced so that the POD reacts quickly to prevent a slip or stumble.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774