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 .
Applicant’s arguments filed in the reply on May 11, 2026 were received and fully considered. Claims 1, 13, and 20 were amended. Claims 5 and 17 were cancelled. Please see below for more detail.
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) 1, 3-4, 6, and 8-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dietl (US 2012/0101596) in view of Flaherty (US 2006/0189900) and further in view of Levin et al (WO 02/49534) (“Levin”).
Regarding Claim 1, while Dietl teaches a method for setting up a controller of an orthopedic device comprising at least one motor drive, the orthopedic device is placed against a body part of a patient and connected to sensors that record control signals of the patient (Abstract, [0005]-[0007] method steps, [0012] done for setting up a control device, [0014] and motor drive-based actuator), including:
outputting an optical, acoustic, and/or tactile representation of an actuation of a limb as a prompt for the patient to recreate a represented actuation ([0005] a prompt given to patient to recreate the represented actuation [0007] representation can be optical, acoustic, or tactile),
capturing control signals produced by the patient after being prompted, wherein the produced control signals are of a reaction by the patient to recreate the represented actuation ([0005]),
assigning the captured control signals to the represented actuation and to a function, wherein the at least one motor drive is activated, deactivated, or reversed in terms a direction of rotation of the motor drive in response to the assigned function ([0008] motor drive activated to carry out desired movement, [0021]-[0022] captured control signals and their patterns are associated with a limb actuation, the function being the activated actuation of the orthopedic specific to signal patterns learned in the learn mode); and
outputting second captured control signals after the assignment to the function to effect desired actuations and functions associated with the second captured control signals ([0021]-[0022] once the captured control signal and association with orthopedic actuation are created, the system is placed in an activation mode where second captured control signals are output to cause the motor to actuate limb movement at a second, later time period from the learn mode), Dietl fails to teach outputting the captured control signals and/or evaluated and prepared captured control signals after the assignment to the function.
However Flaherty teaches a method for setting up a controller of an assistance device (Abstract, Fig. 6, [0058], [0119]-[0136]), the setting up based on sensors that record control signals of a patient ([0026], [0122] sensors that provide control signals / cellular signals include electromyogram signals), including:
outputting an optical, acoustic, and/or tactile representation of an actuation of a limb as a prompt for the patient to recreate a represented actuation ([0120]-[0122]),
capturing control signals produced by the patient after being prompted, wherein the produced control signals are of a reaction by the patient to recreate the represented actuation ([0122]),
assigning the captured control signals to the represented actuation and to a function ([0122]), and
outputting the captured control signals and/or evaluated and prepared captured control signals after the assignment to the function ([0040], [0044] the completion of each step in a training routine may require review by an experienced operator to identify necessary modifications, [0079]-[0082] modification of the assignment of a function may be done by an operator on the basis of captured control signals. Specifically, an interrogation function can be added to the training routines which includes review of the assignment steps, the review including characteristics of the cellular signals themselves, [0092]-[0093] captured control signals / multicellular signals used to control assignment based on undesirable movement, shown either visually in the training routine or exhibited by the patient, or inadequate performance. In summation, the addition of the interrogation function to the steps of Fig 6’s training routine indicates a necessary outputting of captured control signals after an assignment to a function so the operator may review if it will meet desired goals).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the captured control signals of Dietl to be outputted after the assignment to a function as Flaherty teaches this enables a review of the assignment to ensure necessary orthopedic device performance ([0081]-[0082] whether the signal conditioning of the captured control signals is adequate, whether the amplitude of captured control signals is adequate, whether the sampling rate of the captured control signals is sufficient, [0092]-[0093] whether the captured control signals lead to secondary real-world patient movements, whether the captured control signals overlap with visually tested, undesired patient movements).
Yet their combined efforts fail to teach wherein the control signal is assigned to the function on the basis of a signal strength once a predefinable threshold has been exceeded.
However Levin teaches a method for setting up an orthopedic (Abstract) comprising outputting a prompt to create an associated between measured signals and orthopedic actuation (Abstract, p3, L. 3-28) wherein the control signal is assigned to the function on the basis of a signal strength once a predefinable threshold has been exceeded (p22, L. 24-33, a control signal of EMG may be judged by signal strength to distinguish data from noise, a predefinable threshold is generated during a calibration session. Contractions of EMG may then be utilized for assigning based on signal strength in relation to thresholds).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the control signals to be assigned to the function as taught by Dietl on the basis of a signal strength once a predefinable threshold has been exceeded as taught by Levin to clearly distinguish between intentional sensor data and data noise (Levin: p22, L. 24-33).
Regarding Claim 3, Dietl, Flaherty, and Levin teach the method of claim 1, wherein parameters that are relevant to the assignment of the function are derived from the captured control signals ([0005]-[0007] a signal pattern generated from captured control signals, the signal pattern recognized as the parameter relevant to the assignment of the function).
Regarding Claim 4, Dietl, Flaherty, and Levin teach the method of claim 1, and Levin teaches wherein outputting a prompt to create an associated between measured signals and orthopedic actuation has the prompt output in the form of predefined switching signals (p3, L. 3-17, switching signals of measured muscle contractions in a specific pattern can create the association between measured signals and orthopedic actuation).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the prompt with representation of limb actuation of Dietl to further include displayed suggestions of switching signals as taught by Levin to coach the subject in creating a unique association via a signal pattern between the captured control signals and the limb actuation.
Regarding Claim 6, Dietl, Flaherty, and Levin teach the method of claim 1, wherein a confirmation is requested before the assignment of the captured control signal to the function ([0010] “If the signal or signal pattern is sufficiently unique, the next actuation is output. In the process, it is possible, and provision is made therefor, that each actuation be output a number of times in order to obtain confirmation of the signal or the signal pattern.” A requirement of assignment is a certain number of times an output must be repeated before a confirmation is recognized. By requiring a condition to be met before confirmation is recognized, one is requesting confirmation).
Regarding Claim 8, Dietl, Flaherty, and Levin teach the method of claim 1, wherein predefined correction factors are applied to the control signals before assignment (p5, L,18-31, a calibration period performed to find subject-specific timing and magnitude when attempting to recreate a pattern, for subject-specific calibration parameters).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the control signals to be assigned to the function as taught by Dietl wherein predefined correction factors are applied to the control signals before assignment as Levin teaches this optimizes the subject-specific relationship to their prosthetic (p5, L. 18-31).
Regarding Claim 9, Dietl, Flaherty, and Levin teach the method of claim 1, wherein the produced control signals are stored after every prompt ([0005] “The biometric signals, e.g. muscle contractions or electrical impulses in the tracts of nerves, which are produced by the patient after the invitation as a willing, voluntary reaction, are captured by the sensors and associated with the activity carried out. Here, the association is with that actuation that the patient was invited to carry out. This signal association between the produced signals and the actuation carried out and to be carried out is stored.”, [0011]).
Regarding Claim 10, Dietl, Flaherty, and Levin teach the method as claimed in claim 1, wherein the produced control signals are compared to predefined target values and assessed for their relationship to these target values ([0010]-[0011] predefined target values may be the uniqueness of the signal patterns generated, assessed signal patterns and their uniqueness compared to the target values, “This renders it possible to trigger the desired actuation of the technical orthopedic device, even in the case of fuzzy signals. Outputting the invitation in respect of an actuation a number of times in succession increases the uniqueness of the signal association because statistical averaging of the signals can be achieved as a result of the relatively large number of recorded biometric signals, as a result of which individual outliers are not given undue attention.”).
Regarding Claim 11, Dietl, Flaherty, and Levin teach a system for carrying out the method of claim 1, comprising
a. an orthopedic device which is able to be placed against a body part of a patient and which comprises at least one motor drive ([0005] system able to be placed against a body part of a patient, [0020] orthopedic device / prosthesis 1 with motor-driven drives within forearm shaft 10), the system further comprising:
b. an output device which outputs optical, acoustic and/or tactile representations of an actuation of a limb as a prompt for the patient to carry out the represented actuation of a limb ([0022], [0024]-[0025] output device 2),
c. sensors which are connected to the orthopedic device, able to be fastened to the patient, and to record control signals produced by the patient ([0021] collector electrodes 12 / sensors are connected to the patient, able to be fastened to the patient through open end of forearm shaft)
d. an electronic evaluation device in which the control signals produced by the patient as a reaction to recreate the represented actuation following the prompt are processed, evaluated, and assigned to a function ([0021] control electronics receives captured control signals for actuating the drives where the steps of processing, evaluating, and assigning a function are outlined in [0005]-[0008]), and
e. a second output device, in which the function assigned to the control signal is output ([0021] control electronics receives captured control signals and outputs actuations based on their relationship. The actuations reflect the function assigned to the control signal is output, the control electronics also act as a second output device).
Regarding Claim 12, Dietl, Flaherty, and Levin teach the system of claim 11,and Levin further teaches wherein the evaluation device comprises an interface, by means of which the assignment to the function is able to be influenced by a user (p6, L. 26 – p7, L. 2, a button may be provided so a user may indicate that a relationship error between a captured control signal and an output limb actuation).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the control electronics of Dietl to further comprise an interface, by means of which the assignment to the function is able to be influenced by a user as taught by Levin as this provides a mechanism to indicate to the prosthetic that an undesired association is being created by the system, which may be remedied by a recalibration.
Claim(s) 2 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dietl in view of Flaherty and further in view of Levin and further in view of Bravo Castillo (US 2012/0232675).
Regarding Claim 2, while Dietl, Flaherty, and Levin teach the method of claim 1, wherein the captured control signals are recorded by way of at least two electrodes or one electrode pair ([0021] “On the prosthetic shaft 10 in the illustrated embodiment, collector electrodes 12 are also arranged on the proximal, open end of the forearm shaft 10.” Multiple electrodes noted, indicating more than one electrode), their combined efforts fail to teach wherein the control signals are recorded by way of exactly two electrodes or one electrode pair.
However Bravo Castillo teaches a myo-electric based system for controlling a prosthetic (Abstract, [0014]) wherein exactly two electrodes are used to control the prosthetic (Abstract, [0014]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the captured control signals of Dietl to be limited to two electrodes as taught by Bravo Castillo as this still ensures “a diversity of mechanicals movements are generated for the prosthesis according patient necessities in a simply and efficient way,” while also minimizing the needed electrode hardware for the system.
Regarding Claim 20, while Dietl teaches a method for setting up a controller of an orthopedic device comprising at least one motor drive (Abstract, [0005]-[0007] method steps, [0012] done for setting up a control device, [0014] and motor drive-based actuator), the method including the steps of:
placing the orthopedic device against a body part of a patient ([0005]);
connecting the orthopedic device to two electrodes or an electrode pair that record control signals produced by the patient ([0005], [0021] “On the prosthetic shaft 10 in the illustrated embodiment, collector electrodes 12 are also arranged on the proximal, open end of the forearm shaft 10.” Multiple electrodes noted, indicating more than one electrode, and connected to the orthopedic device);
outputting an optical, acoustic, and/or tactile representation of a limb actuation as a prompt for the patient to carry out a represented limb actuation ([0005] a prompt given to patient to carry out limb actuation activity, [0007] representation can be optical, acoustic, or tactile);
capturing control signals produced by the patient after the representation is output with the at least two electrodes or electrode pair ([0005]);
storing the control signals produced by the patient after the representation is output ([0005] “The biometric signals, e.g. muscle contractions or electrical impulses in the tracts of nerves, which are produced by the patient after the invitation as a willing, voluntary reaction, are captured by the sensors and associated with the activity carried out. Here, the association is with that actuation that the patient was invited to carry out. This signal association between the produced signals and the actuation carried out and to be carried out is stored.”, [0011]);
comparing the control signals produced by the patient to predefined target values and assessing the control signals for their relationship to the target values ([0010]-[0011] predefined target values may be the uniqueness of the signal patterns generated, assessed signal patterns and their uniqueness compared to the target values, “This renders it possible to trigger the desired actuation of the technical orthopedic device, even in the case of fuzzy signals. Outputting the invitation in respect of an actuation a number of times in succession increases the uniqueness of the signal association because statistical averaging of the signals can be achieved as a result of the relatively large number of recorded biometric signals, as a result of which individual outliers are not given undue attention.”);
assigning the captured control signals to the represented limb actuation and to a function, wherein the at least one motor drive is activated, deactivated, or reversed in terms a direction of rotation of the motor drive in response to the assigned function ([0008] motor drive activated to carry out desired movement. [0021]-[0022] captured control signals and their patterns are associated with a limb actuation, the function being the activated actuation of the orthopedic specific to signal patterns learned in the learn mode);
requesting confirmation of the assignment of the captured control signal to the function ([0010] “If the signal or signal pattern is sufficiently unique, the next actuation is output. In the process, it is possible, and provision is made therefor, that each actuation be output a number of times in order to obtain confirmation of the signal or the signal pattern.” A requirement of assignment is a certain number of times an output must be repeated before a confirmation is recognized. By requiring a condition to be met before confirmation is recognized, one is requesting confirmation); and
outputting second captured control signals after the assignment to the function to effect desired actuations and functions associated with the second captured control signals ([0021]-[0022] once the captured control signal and association with orthopedic actuation are created, the system is placed in an activation mode where second captured control signals are output to cause the motor to actuate limb movement at a second, later time period from the learn mode), Dietl fails to teach outputting the captured control signals and/or evaluated and prepared captured control signals after the assignment to the function.
However Flaherty teaches a method for setting up a controller of an assistance device (Abstract, Fig. 6, [0058], [0119]-[0136]), the setting up based on sensors that record control signals of a patient ([0026], [0122] sensors that provide control signals / cellular signals include electromyogram signals), including:
outputting an optical, acoustic, and/or tactile representation of an actuation of a limb as a prompt for the patient to recreate a represented actuation ([0120]-[0122]),
capturing control signals produced by the patient after being prompted, wherein the produced control signals are of a reaction by the patient to recreate the represented actuation ([0122]),
assigning the captured control signals to the represented actuation and to a function ([0122]), and
outputting the captured control signals and/or evaluated and prepared captured control signals after the assignment to the function ([0040], [0044] the completion of each step in a training routine may require review by an experienced operator to identify necessary modifications, [0079]-[0082] modification of the assignment of a function may be done by an operator on the basis of captured control signals. Specifically, an interrogation function can be added to the training routines which includes review of the assignment steps, the review including characteristics of the cellular signals themselves, [0092]-[0093] captured control signals / multicellular signals used to control assignment based on undesirable movement, shown either visually in the training routine or exhibited by the patient, or inadequate performance. In summation, the addition of the interrogation function to the steps of Fig 6’s training routine indicates a necessary outputting of captured control signals after an assignment to a function so the operator may review if it will meet desired goals).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the captured control signals of Dietl to be outputted after the assignment to a function as Flaherty teaches this enables a review of the assignment to ensure necessary orthopedic device performance ([0081]-[0082] whether the signal conditioning of the captured control signals is adequate, whether the amplitude of captured control signals is adequate, whether the sampling rate of the captured control signals is sufficient, [0092]-[0093] whether the captured control signals lead to secondary real-world patient movements, whether the captured control signals overlap with visually tested, undesired patient movements).
Yet their combined efforts fail to teach wherein predefined correction factors are applied to the control signals before assignment.
However Levin teaches a method for setting up an orthopedic (Abstract) comprising outputting a prompt to create an associated between measured signals and orthopedic actuation (Abstract, p3, L. 3-28) wherein predefined correction factors are applied to the control signals before assignment (p5, L,18-31, a calibration period performed to find subject-specific timing and magnitude when attempting to recreate a pattern, for subject-specific calibration parameters).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the control signals to be assigned to the function as taught by Dietl wherein predefined correction factors are applied to the control signals before assignment as Levin teaches this optimizes the subject-specific relationship to their prosthetic (p5, L. 18-31).
Yet their combined efforts fail to teach wherein exactly two electrodes are used to control the prosthetic.
However Bravo Castillo teaches a myo-electric based system for controlling a prosthetic (Abstract, [0014]) wherein exactly two electrodes are used to control the prosthetic (Abstract, [0014]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the captured control signals of Dietl to be limited to two electrodes as taught by Bravo Castillo as this still ensures “a diversity of mechanicals movements are generated for the prosthesis according patient necessities in a simply and efficient way,” while also minimizing the needed electrode hardware for the system.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dietl in view of Flaherty and further in view of Levin and further in view of Davie et al (US 2018/0184938) (“Davie”).
Regarding Claim 7, while Dietl, Flaherty, and Levin teach the method of claim 1, and Levin further teaches wherein an error message or a correction suggestion is output in the case of an insufficient signal quality (p6, L. 11-25, “Various techniques known in the art for improving signal-to-noise ratio may be adapted for use in improving the quality of the EMG reading, such as encouraging the subject to overcome the environmental noise by increasing the precision, strength and/or duration of both the low magnitude and the high magnitude contractions.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for lower quality signals in Dietl to be addressed by a correction suggestion as taught by Levin to ensure accuracy of the limb actuation of Dietl based on captured myoelectric control signals of sufficient quality.
Yet their combined efforts fail to teach wherein the control signals are evaluated with respect to the signal quality before the assignment to the function.
However Davie teaches an electromyography based system (Abstract) wherein EMG signals are evaluated with respect to signal quality ([0072] “Hence, in the setup as shown in FIG. 1, an overall quality of an acquired EMG measurement can be determined for example by determining an overall signal to noise ratio.” EMG measurements have their quality determined after acquisition).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the control signals to be assigned to the function as taught by Dietl only after a post-measurement signal quality is ascertained as taught in Davie as a way to identify the influence of “unwanted tonic muscle activity or biopotential and/or motion artifacts” on the myoelectric-based limb actuation of Dietl. Should a signal be too noisy, one of ordinary skill in the art will recognize this as degrading system performance. Furthermore, this initial contact quality evaluation in Davie would obviously be performed before assignment, to prevent the influence of “unwanted tonic muscle activity or biopotential and/or motion artifacts” on the assignment calculations.
Claim(s) 13-16 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dietl in view of Flaherty and further in view of Levin and further in view of Davie and further in view of Bravo Castillo.
Regarding Claim 13, while Dietl teaches a method for setting up a controller of an orthopedic device comprising at least one motor drive (Abstract, [0005]-[0007] method steps, [0012] done for setting up a control device, [0014] and motor drive-based actuator), the method including the steps of:
placing the orthopedic device against a body part of a patient ([0005]);
connecting the orthopedic device to at least two electrodes or an electrode pair that record control signals produced by the patient ([0005], [0021] “On the prosthetic shaft 10 in the illustrated embodiment, collector electrodes 12 are also arranged on the proximal, open end of the forearm shaft 10.” Multiple electrodes noted, indicating more than one electrode, and connected to the orthopedic device);
outputting an optical, acoustic, and/or tactile representation of a limb actuation as a prompt for the patient to carry out the represented limb actuation ([0005] a prompt given to patient to carry out limb actuation activity, [0007] representation can be optical, acoustic, or tactile),
capturing control signals produced by the patient after the representation is output with the at least two electrodes or electrode pair ([0005]);
assigning the captured control signals to the activity carried out and to a function, wherein the at least one motor drive is activated, deactivated, or reversed in terms a direction of rotation of the motor drive in response to the assigned function ([0008] motor drive activated to carry out desired movement. [0021]-[0022] captured control signals and their patterns are associated with a limb actuation, the function being the activated actuation of the orthopedic specific to signal patterns learned in the learn mode);
requesting confirmation of the assignment of the captured control signal to the function ([0010] “If the signal or signal pattern is sufficiently unique, the next actuation is output. In the process, it is possible, and provision is made therefor, that each actuation be output a number of times in order to obtain confirmation of the signal or the signal pattern.” A requirement of assignment is a certain number of times an output must be repeated before a confirmation is recognized. By requiring a condition to be met before confirmation is recognized, one is requesting confirmation); and
outputting second captured control signals after the assignment to the function to effect desired actuations and functions associated with the second captured control signals ([0021]-[0022] once the captured control signal and association with orthopedic actuation are created, the system is placed in an activation mode where second captured control signals are output to cause the motor to actuate limb movement at a second, later time period from the learn mode), Dietl fails to teach outputting the captured control signals and/or evaluated and prepared captured control signals after the assignment to the function.
However Flaherty teaches a method for setting up a controller of an assistance device (Abstract, Fig. 6, [0058], [0119]-[0136]), the setting up based on sensors that record control signals of a patient ([0026], [0122] sensors that provide control signals / cellular signals include electromyogram signals), including:
outputting an optical, acoustic, and/or tactile representation of an actuation of a limb as a prompt for the patient to recreate a represented actuation ([0120]-[0122]),
capturing control signals produced by the patient after being prompted, wherein the produced control signals are of a reaction by the patient to recreate the represented actuation ([0122]),
assigning the captured control signals to the represented actuation and to a function ([0122]), and
outputting the captured control signals and/or evaluated and prepared captured control signals after the assignment to the function ([0040], [0044] the completion of each step in a training routine may require review by an experienced operator to identify necessary modifications, [0079]-[0082] modification of the assignment of a function may be done by an operator on the basis of captured control signals. Specifically, an interrogation function can be added to the training routines which includes review of the assignment steps, the review including characteristics of the cellular signals themselves, [0092]-[0093] captured control signals / multicellular signals used to control assignment based on undesirable movement, shown either visually in the training routine or exhibited by the patient, or inadequate performance. In summation, the addition of the interrogation function to the steps of Fig 6’s training routine indicates a necessary outputting of captured control signals after an assignment to a function so the operator may review if it will meet desired goals).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the captured control signals of Dietl to be outputted after the assignment to a function as Flaherty teaches this enables a review of the assignment to ensure necessary orthopedic device performance ([0081]-[0082] whether the signal conditioning of the captured control signals is adequate, whether the amplitude of captured control signals is adequate, whether the sampling rate of the captured control signals is sufficient, [0092]-[0093] whether the captured control signals lead to secondary real-world patient movements, whether the captured control signals overlap with visually tested, undesired patient movements).
Yet their combined efforts fail to teach wherein the control signals are evaluated with respect to the signal quality before the assignment to the function and wherein an error message or a correction suggestion is output in the case of an insufficient signal quality.
However Davie teaches an electromyography based system (Abstract) wherein EMG signals are evaluated with respect to signal quality ([0072] “Hence, in the setup as shown in FIG. 1, an overall quality of an acquired EMG measurement can be determined for example by determining an overall signal to noise ratio.” EMG measurements have their quality determined after acquisition).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the control signals to be assigned to the function as taught by Dietl only after a post-measurement signal quality is ascertained as taught in Davie as a way to identify the influence of “unwanted tonic muscle activity or biopotential and/or motion artifacts” on the myoelectric-based limb actuation of Dietl. Should a signal be too noisy, one of ordinary skill in the art will recognize this as degrading system performance. Furthermore, this initial contact quality evaluation in Davie would obviously be performed before assignment, to prevent the influence of “unwanted tonic muscle activity or biopotential and/or motion artifacts” on the assignment calculations.
Yet their combined efforts fail to teach wherein an error message or a correction suggestion is output in the case of an insufficient signal quality.
However Levin teaches a method for setting up an orthopedic (Abstract) comprising outputting a prompt to create an associated between measured signals and orthopedic actuation (Abstract, p3, L. 3-28) wherein an error message or a correction suggestion is output in the case of an insufficient signal quality (p6, L. 11-25, “Various techniques known in the art for improving signal-to-noise ratio may be adapted for use in improving the quality of the EMG reading, such as encouraging the subject to overcome the environmental noise by increasing the precision, strength and/or duration of both the low magnitude and the high magnitude contractions.”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the recognized lower quality signals of Dietl and Davie to be addressed by a correction suggestion as taught by Levin to ensure accuracy of the limb actuation of Dietl based on captured myoelectric control signals of sufficient quality.
Yet their combined efforts fail to teach wherein the control signals are recorded by way of two electrodes or one electrode pair.
However Bravo Castillo teaches a myo-electric based system for controlling a prosthetic (Abstract, [0014]) wherein exactly two electrodes are used to control the prosthetic (Abstract, [0014]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the captured control signals of Dietl to be limited to two electrodes as taught by Bravo Castillo as this still ensures “a diversity of mechanicals movements are generated for the prosthesis according patient necessities in a simply and efficient way,” while also minimizing the needed electrode hardware for the system.
Regarding Claim 14, Dietl, Flaherty, Davie, Levin, and Bravo Castillo teach the method of claim 13, and Dietl teaches wherein control signal parameters that are relevant to the assignment of the function to be assigned are derived from the captured control signals ([0005]-[0007] a signal pattern generated from captured control signals, the signal pattern recognized as the parameter relevant to the assignment of the function).
Regarding Claim 15, Dietl, Flaherty, Davie, Levin, and Bravo Castillo teach the method of claim 13, and Levin teaches wherein outputting a prompt to create an associated between measured signals and orthopedic actuation has the prompt output in the form of predefined switching signals (p3, L. 3-17, switching signals of measured muscle contractions in a specific pattern can create the association between measured signals and orthopedic actuation).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the prompt with representation of limb actuation of Dietl to further include displayed suggestions of switching signals as taught by Levin to coach the subject in creating a unique association via a signal pattern between the captured control signals and the limb actuation.
Regarding Claim 16, Dietl, Flaherty, Davie, Levin, and Bravo Castillo teach the method of claim 13, and Levin further teaches wherein the control signal is assigned to the function on the basis of a signal strength once a predefinable threshold has been exceeded (p22, L. 24-33, a control signal of EMG may be judged by signal strength to distinguish data from noise, a predefinable threshold is generated during a calibration session. Contractions of EMG may then be utilized for assigning based on signal strength in relation to thresholds).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the control signals to be assigned to the function as taught by Dietl on the basis of a signal strength once a predefinable threshold has been exceeded as taught by Levin to clearly distinguish between intentional sensor data and data noise (Levin: p22, L. 24-33).
Regarding Claim 18, Dietl, Flaherty, Davie, Levin, and Bravo Castillo teach the method of claim 13, and Levin further teaches wherein predefined correction factors are applied to the control signals before assignment (p5, L,18-31, a calibration period performed to find subject-specific timing and magnitude when attempting to recreate a pattern, for subject-specific calibration parameters).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the control signals to be assigned to the function as taught by Dietl wherein predefined correction factors are applied to the control signals before assignment as Levin teaches this optimizes the subject-specific relationship to their prosthetic (p5, L. 18-31).
Regarding Claim 19, Dietl, Flaherty, Davie, Levin, and Bravo Castillo teach the method of claim 13, and Dietl teaches wherein the control signals produced by the patient as a reaction to recreate the represented actuation following the prompt are stored after every prompt ([0005] “The biometric signals, e.g. muscle contractions or electrical impulses in the tracts of nerves, which are produced by the patient after the invitation as a willing, voluntary reaction, are captured by the sensors and associated with the activity carried out. Here, the association is with that actuation that the patient was invited to carry out. This signal association between the produced signals and the actuation carried out and to be carried out is stored.”, [0011]).
Response to Arguments
Applicant’s amendments and arguments filed 5/11/2026 with respect to the 35 USC 103 rejections have been fully considered, but are not persuasive over the cited prior art.
Applicant argues in regards to claim 1, cancelled claim 5, and the 35 USC 103 rejection under Levin, that Levin does not describe or suggest assigning a control signal to any function based on signal strength. Examiner respectfully disagrees on the basis that the claim is rejected based on the combination of Dietl, Flaherty, and Levin. Dietl teaches assigning a control signal to a function based on contractions. Levin teaches a minimum threshold for judging when a contraction is meaningfully different from noise. One of ordinary skill in the art would recognize the applicability of a meaningful contraction from Levin would improve assigning of Dietl by obviating noise as a confounding factor.
Applicant argues in regards to claim 13, cancelled claim 17, and the 35 USC 103 rejection under Davie, that Davie does not describe or suggest evaluating signal quality prior to assignment to a function. Examiner respectfully disagrees, but will explain further. Davie notes that EMG data should be judged for contact quality after measuring EMG data. In the steps of Dietl, EMG data must be measured prior to assigning steps. It would be obvious that the EMG contact quality would be judged after measuring, but before assigning to prevent unwanted sources of error to propagate into assigned functionality of the prosthetic.
Applicant argues in response to claim 20, claim 8, and the 35 USC rejection under Levin, that Levin does not teach predefined correction factors applied to the control signals before assignment. Examiner respectfully disagrees. The passage of Levin begins “In some preferred embodiments of the present invention, one or more calibration parameters are modified, so as to optimize the relationship between the subject and the virtual prosthesis displayed on the screen of the training computer, and, more importantly, the relationship between the subject and the actual electromechanical prosthesis with which s/he will ultimately be fitted.” The user in Levin is not merely being asked to enter a calibration pattern, but enter a calibration pattern to develop corrections factors based on timing and magnitude of user actions. Further, specific details on how this is accomplished can be found, for example, in page 21 of Levin.
The rejections stand.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
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