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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “timing of the first flexion assistance is aligned with a velocity peak of the gait cycle” from claim 38 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim 38 positively recites, “wherein timing of the first flexion assistance is aligned with a velocity peak of the gait cycle.” It is unclear where in the specification or drawings that this limitation is disclosed. The only mention of velocity from the specification being in [82] in relation to the determination of amplitude. Nothing indicating a “velocity peak” is disclosed.
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.
Claims 31-32, 34, 39, 44-45, and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Unluhisarcikli (WO 2013049658 A1).
Regarding claim 31, Unluhisarcikli discloses a system for mitigating or correcting knee hyperextension in a user with an assistive lower-limb exoskeleton (FIG. 3 An Active Knee Rehabilitation Orthotic System as set forth in the abstract, [0002], and [0019]), wherein the system is arranged: (a) to identify a first hyperextension in a knee joint of a user's limb during a stance phase of a gait cycle (FIG. 1 As set forth in [0019]; Sensors located at each joint measure joint angles, which are used for controls and gait monitoring as set forth in [0058], the sensor data is used by the impedance controller to compute a desired knee angle at the first rotatable knee joint and to command a torque at the second rotatable knee joint based in part on the desired knee angle as set forth in [0020]; the gate deviation targeted, and therefore identified, by the controller being represented by the initial sensor data, which could include that of knee hyper extension); (b) to determine a first flexion assistance (FIG. 8 The resulting requested torque passed to the ANdROS derived from the desired torque 805 as set forth in [0062]-[0064]) for an assistance profile (The target gait trajectory as set forth in [0062]-[0063]) based on the first hyperextension of a knee joint by (Which would be indicated by the measured knee angles 801 as set forth in [0063]): (i) determining a timing of the first flexion assistance (The desired knee angle is generated from the estimation of gait phase based on a human-machine synchronization algorithm, this would be inclusive of an ideal reference trajectory that needs to be established, which accounts for walking velocity, cadence, and step length, as set forth in [0069] and [0076]-[0077], wherein the cadence would reflect a timing in which the flexion assistance should be implemented that is taken into consideration by the impedance control loop when determining the flexion assistance); (ii) determining a duration of the first flexion assistance (FIG. 8 One additional input to the impedance control loop is the desired knee angle, wherein the desired knee angle is generated from the estimation of gait phase, which include gait events such as heel strike and toe off which may be recorded to help normalize the time scale to one full gait cycle as set forth in [0069]-[0071], wherein the time scale of a full gait cycle, or even the velocity or cadence as set forth in [0076], would reflect a duration for which the flexion assistance should be implemented that is taken into consideration by the impedance control loop when determining the flexion assistance); and (iii) determining an amplitude of the first flexion assistance (FIG. 8 An impedance controller uses the sensor data in a feedback loop that computes a desired knee angle and a desired torque as set forth in [0046]; the desired torque supplied to the motor being the resulting requested torque passed to the brushless motor and amplifier of the ANdROS after the measured torque 806 and the desired torque 805 are compared to produce a torque error 807 and a gain 808 is applied and compared with gravity and friction feedback measurements 809); (c) to apply an assistive flexion torque by the assistive lower-limb exoskeleton to a user's limb during the stance phase (A desired gait pattern is being reinforced by the invention that targets gait deviations such a knee hyperextension during the stance phase as set forth in [0002], indicating that the assistive torque is being provided during the stance phase) according to the first flexion assistance of the assistance profile (FIG. 8 Desired torque 805 as set forth in [0062]-[0063]).
Regarding claim 32, Unluhisarcikli discloses the claimed invention substantially as claimed as set forth for claim 31 above.
Unluhisarcikli further discloses, wherein the system is further arranged to: (d) identify a second hyperextension or a first flexion in a knee joint of a user's limb during the stance phase of step (c); (e) adjust the first flexion assistance based on the identification of the second hyperextension or the first flexion in a knee joint to determine a second flexion assistance; (f) apply an assistive flexion torque to a user's limb during the stance phase according to the second flexion assistance (FIG. 8 The impedance controller uses the sensor data in a feedback loop that computes a desired knee angle and a desired torque as set forth in [0046], the feedback loop including the steps of: identifying a knee flexion, adjusting the flexion assistance based on the flexion to determine a second flexion assistance, and applying an assistive toque during the stance phase; shown in FIG. 8 As set forth in [0019]; Sensors located at each joint measure joint angles, which are used for controls and gait monitoring as set forth in [0058], the sensor data is used by the impedance controller to compute a desired knee angle at the first rotatable knee joint and to command a torque at the second rotatable knee joint based in part on the desired knee angle as set forth in [0020]; the gate deviation targeted, and therefore identified, by the controller being represented by the initial sensor data, which could include that of knee hyper extension or a first flexion, the resulting requested torque passed to the brushless motor and amplifier of the ANdROS, derived from the desired torque 805 as set forth in [0062]-[0064]).
Regarding claim 34, Unluhisarcikli discloses the claimed invention substantially as claimed as set forth for claim 32 above.
Unluhisarcikli further discloses, wherein adjustment of the first flexion assistance based on the identification of the second hyperextension or the first flexion in the knee joint to determine a second flexion assistance comprises increasing or decreasing the timing of the second flexion assistance relative to the first flexion assistance in response to identifying the second hyperextension in the knee joint (The desired knee angle is generated from the estimation of gait phase based on a human-machine synchronization algorithm, this would be inclusive of an ideal reference trajectory that needs to be established, which accounts for walking velocity, cadence, and step length, as set forth in [0069] and [0076]-[0077], wherein the cadence would reflect a timing in which the flexion assistance should be implemented that is taken into consideration by the impedance control loop when determining the flexion assistance, the increased or decreased timing of the second flexion assistance relative to the first flexion assistance depending on the measured 801 and desired knee angles 802 as set forth in [0063]).
Regarding claim 39, Unluhisarcikli discloses the claimed invention substantially as claimed as set forth for claim 31 above.
Unluhisarcikli further discloses, wherein the assistive flexion torque is arranged to be applied to a user's limb above the knee joint (FIG. 6 The actuated brace 602 is driven by a brushless DC motor 609 coupled to a gearbox 610 and the torque generated by the motor is transferred to the knee joint by means of a push bar 611 to the tension/compression load cell 612 as set forth in [0057], the brace itself being located above/over the surface of the patients lower extremities and joints).
Regarding claim 44, Unluhisarcikli discloses a method for mitigating or correcting knee hyperextension in a user (As set forth in [0019]), the method comprising: (a) identifying a first hyperextension in a knee joint of a user's limb during a stance phase of a gait cycle (FIG. 1 As set forth in [0019]; Sensors located at each joint measure joint angles, which are used for controls and gait monitoring as set forth in [0058], the sensor data is used by the impedance controller to compute a desired knee angle at the first rotatable knee joint and to command a torque at the second rotatable knee joint based in part on the desired knee angle as set forth in [0020]; the gate deviation targeted, and therefore identified, by the controller being represented by the initial sensor data, which could include that of knee hyper extension); (b) determining a first flexion assistance (FIG. 8 The resulting requested torque passed to the ANdROS derived from the desired torque 805 as set forth in [0062]-[0064]) for an assistance profile (The target gait trajectory as set forth in [0062]-[0063]) based on the first hyperextension of a knee joint (Which would be indicated by the measured knee angles 801 as set forth in [0063]), said determining comprising: (i) determining a timing of the first flexion assistance (The desired knee angle is generated from the estimation of gait phase based on a human-machine synchronization algorithm, this would be inclusive of an ideal reference trajectory that needs to be established, which accounts for walking velocity, cadence, and step length, as set forth in [0069] and [0076]-[0077], wherein the cadence would reflect a timing in which the flexion assistance should be implemented that is taken into consideration by the impedance control loop when determining the flexion assistance); (ii) determining a duration of the first flexion assistance (FIG. 8 One additional input to the impedance control loop is the desired knee angle, wherein the desired knee angle is generated from the estimation of gait phase, which include gait events such as heel strike and toe off which may be recorded to help normalize the time scale to one full gait cycle as set forth in [0069]-[0071], wherein the time scale of a full gait cycle, or even the velocity or cadence as set forth in [0076], would reflect a duration for which the flexion assistance should be implemented that is taken into consideration by the impedance control loop when determining the flexion assistance); and (iii) determining an amplitude of the first flexion assistance (FIG. 8 An impedance controller uses the sensor data in a feedback loop that computes a desired knee angle and a desired torque as set forth in [0046]; the desired torque supplied to the motor being the resulting requested torque passed to the brushless motor and amplifier of the ANdROS after the measured torque 806 and the desired torque 805 are compared to produce a torque error 807 and a gain 808 is applied and compared with gravity and friction feedback measurements 809); (c) applying an assistive flexion torque to a user's limb during the stance phase (A desired gait pattern is being reinforced by the invention that targets gait deviations such a knee hyperextension during the stance phase as set forth in [0002], indicating that the assistive torque is being provided during the stance phase) according to the first flexion assistance of the assistance profile (FIG. 8 Desired torque 805 as set forth in [0062]-[0063]).
Regarding claim 45, Unluhisarcikli discloses the claimed invention substantially as claimed as set forth for claim 44 above.
Unluhisarcikli further discloses, the method further comprising the steps of: (d) identifying a second hyperextension or a first flexion in the knee joint of the user's limb during the stance phase of step (c); (e) adjusting the first flexion assistance based on the identification of the second hyperextension or the first flexion in the knee joint to determine a second flexion assistance; (f) applying an assistive flexion torque to the user's limb during the stance phase according to the second flexion assistance (FIG. 8 The impedance controller uses the sensor data in a feedback loop that computes a desired knee angle and a desired torque as set forth in [0046], the feedback loop including the steps of: identifying a knee flexion, adjusting the flexion assistance based on the flexion to determine a second flexion assistance, and applying an assistive toque during the stance phase; shown in FIG. 8 As set forth in [0019]; Sensors located at each joint measure joint angles, which are used for controls and gait monitoring as set forth in [0058], the sensor data is used by the impedance controller to compute a desired knee angle at the first rotatable knee joint and to command a torque at the second rotatable knee joint based in part on the desired knee angle as set forth in [0020]; the gate deviation targeted, and therefore identified, by the controller being represented by the initial sensor data, which could include that of knee hyper extension or a first flexion, the resulting requested torque passed to the brushless motor and amplifier of the ANdROS, derived from the desired torque 805 as set forth in [0062]-[0064]).
Regarding claim 47, Unluhisarcikli discloses the claimed invention substantially as claimed as set forth for claim 45 above.
Unluhisarcikli further discloses, wherein the step of adjusting the first flexion assistance based on the identification of the second hyperextension or the first flexion in the knee joint to determine a second flexion assistance comprises increasing or decreasing the timing of the second flexion assistance relative to the first flexion assistance in response to identifying the second hyperextension in the knee joint (The desired knee angle is generated from the estimation of gait phase based on a human-machine synchronization algorithm, this would be inclusive of an ideal reference trajectory that needs to be established, which accounts for walking velocity, cadence, and step length, as set forth in [0069] and [0076]-[0077], wherein the cadence would reflect a timing in which the flexion assistance should be implemented that is taken into consideration by the impedance control loop when determining the flexion assistance, the increased or decreased timing of the second flexion assistance relative to the first flexion assistance depending on the measured 801 and desired knee angles 802 as set forth in [0063]).
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.
Claims 33, 35 -37, 46, 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over Unluhisarcikli (WO 2013049658 A1) as applied to claims 31-32 and 44-45.
Regarding claim 33, Unluhisarcikli discloses the claimed invention substantially as claimed as set forth for claim 32 above.
Unluhisarcikli further discloses, wherein adjustment of the first flexion assistance based on the identification of the second hyperextension or the first flexion in the knee joint to determine a second flexion assistance comprises changing the amplitude of the second flexion assistance relative to the first flexion assistance in response to identifying the second hyperextension in the knee joint (The system targets primary gait deviations like knee hyperextension during stance by reinforcing a desired gait pattern via corrective torque-fields applied around the knee joint as set forth in [0019], according to the impedance controller of FIG. 8, the measured knee angle, which could be the knee angle resulting from the first flexion assistance, is what determines the second flexion assistance, that flexion assistance being inclusive of an amplitude as set forth for claim 31 above).
While Unluhisarcikli doesn’t explicitly disclose that the second flexion assistance comprises increasing the amplitude of the second flexion assistance relative to the first flexion assistance in response to identifying the second hyperextension in the knee joint, it would be obvious to one of ordinary skill in the art that if a hyperextension is present after the first flexion assistance is delivered, the amplitude would be increased given the impedance controller implemented on ANdROS as illustrated in Figure 8. The outer position loop mandates the desired interaction torque, based on the deviation from the desired trajectory and the impedance parameters. (FIG. 8 Specifically, the measured 801 and desired knee angles 802 are compared and produce a position error 803. The position error is supplied to the spring/damper model 804 of the patient's leg which generated a desired torque 805 as set forth in [0063]). During gait retraining, the corrective forces are applied in response to deviations from the ideal reference trajectory. It follows that when the patient is walking "correctly" the interaction forces between the human and the robot should be ideally zero (As set forth in [0089]). Providing an increased amplitude in terms of flexion assistance would be obvious to one of ordinary skill in the art because if a user’s knee goes beyond the desired gait trajectory, the deviation is large, and the corrective assistance torque would require an increased amplitude to ensure the knee joint angle is corrected to follow the desired trajectory. In other words, it would be obvious that given a second hyperextension of the knee joint, an increase in amplitude should be applied to the second flexion assistance in order to provide a stronger corrective force/torque to the user’s joint, to achieve a desired trajectory.
Regarding claim 35, Unluhisarcikli discloses the claimed invention substantially as claimed as set forth for claim 32 above.
Unluhisarcikli further discloses, wherein adjustment of the first flexion assistance based on the identification of the second hyperextension or the first flexion in the knee joint to determine a second flexion assistance comprises changing the amplitude of the second flexion assistance relative to the first flexion assistance in response to identifying the second hyperextension in the knee joint (The system targets primary gait deviations like knee hyperextension during stance by reinforcing a desired gait pattern via corrective torque-fields applied around the knee joint as set forth in [0019], according to the impedance controller of FIG. 8, the measured knee angle, which could be the knee angle resulting from the first flexion assistance, is what determines the second flexion assistance, that flexion assistance being inclusive of an amplitude as set forth for claim 31 above.)
While Unluhisarcikli doesn’t explicitly disclose that the second flexion assistance comprises decreasing the amplitude of the second flexion assistance relative to the first flexion assistance in response to identifying the second hyperextension in the knee joint, it would be obvious to one of ordinary skill in the art that if a hyperextension is present after the first flexion assistance is delivered, the amplitude would be decreased given the impedance controller implemented on ANdROS as illustrated in Figure 8. The outer position loop mandates the desired interaction torque, based on the deviation from the desired trajectory and the impedance parameters. (FIG. 8 Specifically, the measured 801 and desired knee angles 802 are compared and produce a position error 803. The position error is supplied to the spring/damper model 804 of the patient's leg which generated a desired torque 805 as set forth in [0063]). During gait retraining, the corrective forces are applied in response to deviations from the ideal reference trajectory. It follows that when the patient is walking "correctly" the interaction forces between the human and the robot should be ideally zero (As set forth in [0089]). Providing a decreased amplitude in terms of flexion assistance would be obvious to one of ordinary skill in the art because if a user’s knee overshoots into hyperextension and goes beyond the desired knee angle for the gait trajectory, a lower amplitude of corrective assistance torque would ensure the knee joint angle is corrected to follow the desired trajectory and achieve a desired knee angle. In other words, it would be obvious that given a second hyperextension of the knee joint, a decrease in amplitude should be applied to the second flexion assistance in order to prevent an overcompensation of corrective force/torque to the user’s joint, to achieve a desired trajectory.
Regarding claim 36, Unluhisarcikli discloses the claimed invention substantially as claimed as set forth for claim 31 above.
Unluhisarcikli fails to explicitly disclose, wherein timing of the first flexion assistance is within a range of 15% to 40% of the gait cycle.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make wherein the timing of the first flexion assistance is within a range of 15% to 40% of the gait cycle in the device of Unluhisarcikli because Applicant has not disclosed that the specific range of the gait cycle provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the specification states in [20] that “The timing of the flexion assistance may be coordinated to the user's particular needs by matching the timing of the flexion assistance to an identified timing of the hyperextension of the knee or to a timing of a middle region of a stance phase of the gait cycle. For example, the timing of the flexion assistance may be within a range of 15% to 40% of the gait cycle, particularly 20% to 35% of the gait cycle, or more particularly 25% to 30% of the gait cycle and may be fine-tuned to the specific needs and characteristics of the user”, which would be true for any timing of the flexion assistance coordinated to the user's particular needs. Additionally, as explained in MPEP § 2144, subsection II, the discovery of optimum or workable ranges or values are obvious to one of ordinary skill in the art In KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Additionally, In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), it was held that it is not inventive to discover the optimum or workable ranges by routine experimentation. One of ordinary skill in the art, furthermore, would have expected the range of the gait cycle of Unluhisarcikli, and Applicant’s range, to perform equally well because both ranges allow for the same function of ensuring the flexion assistance may be coordinated to the user's particular needs.
Therefore, it would have been prima facie obvious to Unluhisarcikli to obtain the invention as specified in claim 36, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired flexion assistance and thus fails to patentably distinguish over the prior art of Unluhisarcikli.
Regarding claim 37, Unluhisarcikli discloses the claimed invention substantially as claimed as set forth for claim 31 above.
Unluhisarcikli fails to explicitly disclose, wherein the amplitude of the first flexion assistance is within a range of 1.0 N*m to 3.0 N*m.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make wherein the amplitude of the first flexion assistance is within a range of 1.0 N*m to 3.0 N*m in the device of Unluhisarcikli because Applicant has not disclosed that the specific range of amplitude provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the specification states in [82] that “The amplitude of the flexion assistance may be within a range of 1.0 N*m to 3.0 N*m, particularly 1.5 N*m to 2.5 N*m, or more particularly 1.75 N*m to 2.25 N*m and may be fine-tuned to the specific needs and characteristics of the user”, which would be true for any amplitude of the flexion assistance coordinated to the user's particular needs. Additionally, as explained in MPEP § 2144, subsection II, the discovery of optimum or workable ranges or values are obvious to one of ordinary skill in the art In KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Additionally, In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), it was held that it is not inventive to discover the optimum or workable ranges by routine experimentation. One of ordinary skill in the art, furthermore, would have expected the amplitude range of Unluhisarcikli, and Applicant’s range, to perform equally well because both ranges allow for the same function of ensuring the flexion assistance may be tuned to the user's particular needs.
Therefore, it would have been prima facie obvious to Unluhisarcikli to obtain the invention as specified in claim 37, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired flexion assistance and thus fails to patentably distinguish over the prior art of Unluhisarcikli.
Regarding claim 46, Unluhisarcikli discloses the claimed invention substantially as claimed as set forth for claim 45 above.
Unluhisarcikli further discloses, wherein the step of adjusting the first flexion assistance based on the identification of the second hyperextension or the first flexion in the knee joint to determine a second flexion assistance comprises changing the amplitude of the second flexion assistance relative to the first flexion assistance in response to identifying the second hyperextension in the knee joint (The system targets primary gait deviations like knee hyperextension during stance by reinforcing a desired gait pattern via corrective torque-fields applied around the knee joint as set forth in [0019], according to the impedance controller of FIG. 8, the measured knee angle, which could be the knee angle resulting from the first flexion assistance, is what determines the second flexion assistance, that flexion assistance being inclusive of an amplitude as set forth for claim 44 above).
While Unluhisarcikli doesn’t explicitly disclose that the second flexion assistance comprises increasing the amplitude of the second flexion assistance relative to the first flexion assistance in response to identifying the second hyperextension in the knee joint, it would be obvious to one of ordinary skill in the art that if a hyperextension is present after the first flexion assistance is delivered, the amplitude would be increased given the impedance controller implemented on ANdROS as illustrated in Figure 8. The outer position loop mandates the desired interaction torque, based on the deviation from the desired trajectory and the impedance parameters. (FIG. 8 Specifically, the measured 801 and desired knee angles 802 are compared and produce a position error 803. The position error is supplied to the spring/damper model 804 of the patient's leg which generated a desired torque 805 as set forth in [0063]). During gait retraining, the corrective forces are applied in response to deviations from the ideal reference trajectory. It follows that when the patient is walking "correctly" the interaction forces between the human and the robot should be ideally zero (As set forth in [0089]). Providing an increased amplitude in terms of flexion assistance would be obvious to one of ordinary skill in the art because if a user’s knee goes beyond the desired gait trajectory, the deviation is large, and the corrective assistance torque would require an increased amplitude to ensure the knee joint angle is corrected to follow the desired trajectory. In other words, it would be obvious that given a second hyperextension of the knee joint, an increase in amplitude should be applied to the second flexion assistance in order to provide a stronger corrective force/torque to the user’s joint, to achieve a desired trajectory.
Regarding claim 48, Unluhisarcikli discloses the claimed invention substantially as claimed as set forth for claim 45 above.
Unluhisarcikli further discloses, wherein the step of adjusting the first flexion assistance based on the identification of the second hyperextension or the first flexion in the knee joint to determine a second flexion assistance comprises changing the amplitude of the second flexion assistance relative to the first flexion assistance in response to identifying the first flexion in the knee joint (The system targets primary gait deviations like knee hyperextension during stance by reinforcing a desired gait pattern via corrective torque-fields applied around the knee joint as set forth in [0019], according to the impedance controller of FIG. 8, the measured knee angle, which could be the knee angle resulting from the first flexion assistance, is what determines the second flexion assistance, that flexion assistance being inclusive of an amplitude as set forth for claim 44 above).
While Unluhisarcikli doesn’t explicitly disclose that the second flexion assistance comprises decreasing the amplitude of the second flexion assistance relative to the first flexion assistance in response to identifying the second hyperextension in the knee joint, it would be obvious to one of ordinary skill in the art that if a hyperextension is present after the first flexion assistance is delivered, the amplitude would be decreased given the impedance controller implemented on ANdROS as illustrated in Figure 8. The outer position loop mandates the desired interaction torque, based on the deviation from the desired trajectory and the impedance parameters. (FIG. 8 Specifically, the measured 801 and desired knee angles 802 are compared and produce a position error 803. The position error is supplied to the spring/damper model 804 of the patient's leg which generated a desired torque 805 as set forth in [0063]). During gait retraining, the corrective forces are applied in response to deviations from the ideal reference trajectory. It follows that when the patient is walking "correctly" the interaction forces between the human and the robot should be ideally zero (As set forth in [0089]). Providing a decreased amplitude in terms of flexion assistance would be obvious to one of ordinary skill in the art because if a user’s knee overshoots into hyperextension and goes beyond the desired knee angle for the gait trajectory, a lower amplitude of corrective assistance torque would ensure the knee joint angle is corrected to follow the desired trajectory and achieve a desired knee angle. In other words, it would be obvious that given a second hyperextension of the knee joint, a decrease in amplitude should be applied to the second flexion assistance in order to prevent an overcompensation of corrective force/torque to the user’s joint, to achieve a desired trajectory.
Regarding claim 49, Unluhisarcikli discloses the claimed invention substantially as claimed as set forth for claim 44 above.
Unluhisarcikli fails to explicitly disclose, wherein the amplitude of the first flexion assistance is within a range of 1.0 N*m to 3.0 N*m.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make wherein the amplitude of the first flexion assistance is within a range of 1.0 N*m to 3.0 N*m in the device of Unluhisarcikli because Applicant has not disclosed that the specific range of amplitude provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the specification states in [82] that “The amplitude of the flexion assistance may be within a range of 1.0 N*m to 3.0 N*m, particularly 1.5 N*m to 2.5 N*m, or more particularly 1.75 N*m to 2.25 N*m and may be fine-tuned to the specific needs and characteristics of the user”, which would be true for any amplitude of the flexion assistance coordinated to the user's particular needs. Additionally, as explained in MPEP § 2144, subsection II, the discovery of optimum or workable ranges or values are obvious to one of ordinary skill in the art In KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Additionally, In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), it was held that it is not inventive to discover the optimum or workable ranges by routine experimentation. One of ordinary skill in the art, furthermore, would have expected the amplitude range of Unluhisarcikli, and Applicant’s range, to perform equally well because both ranges allow for the same function of ensuring the flexion assistance may be tuned to the user's particular needs.
Therefore, it would have been prima facie obvious to Unluhisarcikli to obtain the invention as specified in claim 49, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired flexion assistance and thus fails to patentably distinguish over the prior art of Unluhisarcikli.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Unluhisarcikli (WO 2013049658 A1) as applied to claim 31, in view of Ding (Ding, Y., Panizzolo, F.A., Siviy, C. et al. Effect of timing of hip extension assistance during loaded walking with a soft exosuit. J NeuroEngineering Rehabil 13, 87 (2016). https://doi.org/10.1186/s12984-016-0196-8; Accessed 3/17/2026).
Regarding claim 38, Unluhisarcikli discloses the claimed invention substantially as claimed as set forth for claim 31 above.
Unluhisarcikli fails to explicitly disclose, wherein timing of the first flexion assistance is aligned with a velocity peak of the gait cycle.
However, Ding teaches wherein flexion assistance is aligned with a velocity peak of the gait cycle (Ding: A better synchronization of actuation with a period of high hip joint velocity can deliver more positive mechanical power to the wearer as set forth on page 2 column 2 paragraph 2).
Unluhisarcikli and Ding are both considered to be analogous to the claimed invention because they are in the same field of exoskeletons providing flexion assistance to a user’s limbs. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the timing of assistance of Unluhisarcikli to incorporate the teaching of Ding and include wherein flexion assistance is aligned with a velocity peak of the gait cycle (Ding: A better synchronization of actuation with a period of high hip joint velocity can deliver more positive mechanical power to the wearer as set forth on page 2 column 2 paragraph 2). Doing so would deliver more positive mechanical power to the wearer (Ding: As set forth on page 2 column 2 paragraph 2).
Claims 40-41 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Unluhisarcikli (WO 2013049658 A1) as applied to claims 31 and 44, in view of Roh (US 20150134080 A1).
Regarding claim 40, Unluhisarcikli discloses the claimed invention substantially as claimed as set forth for claim 31 above.
Unluhisarcikli further discloses, wherein the assistive lower-limb exoskeleton comprises (FIG. 6 Actuated brace 602): a frame arranged to fit about at least one limb (FIG. 6 The frame as set forth in the annotated figure below); an actuation system arranged to apply a force to the frame (FIG. 6 The actuated brace 602 is driven by a brushless DC motor 609 coupled to a gearbox 610 and the torque generated by the motor is transferred to the knee joint by means of a push bar 611 and then a tension/compression load cell 612, which connects with the frame); and a controller, the controller arranged to actuate the actuation system at least during a stance phase, at an amplitude, a duration and a timing based on a knee hyperextension of the at least one limb (FIG. 8 The impedance controller implemented on ANdROS is illustrated in Figure 8, the resulting requested torque being passed to the ANdROS brushless motor and amplifier as set forth in [0063]-[0064]).
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Unluhisarcikli fails to explicitly disclose, wherein the controller includes a processor.
However, Roh teaches, wherein the controller includes a processor (Roh: As set forth in [0178}-[0179]).
Unluhisarcikli and Ding are both considered to be analogous to the claimed invention because they are in the same field of exoskeletons providing flexion assistance to a user’s limbs. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Unluhisarcikli to incorporate the teaching of Roh and include wherein the controller includes a processor (Roh: As set forth in [0178]-[0179]). Doing so provides a well-known component included in a controller for responding to and executing instructions (Roh: As set forth in [0179]).
Regarding claim 41, Unluhisarcikli as modified discloses the claimed invention substantially as claimed as set forth for claim 40 above.
Unluhisarcikli as modified further discloses, wherein the assistive lower-limb exoskeleton is in communication with at least one sensor arranged to determine at least one gait parameter (Sensors located at each joint measure joint angles, which are used for controls and gait monitoring as set forth in [0058]); wherein the controller is arranged to determine the amplitude, the duration and the timing based on the at least one gait parameter (FIG. 8 The data is further used in the impedance controller implemented on ANdROS, the resulting requested torque depending on the data obtained).
Regarding claim 50, Unluhisarcikli discloses the claimed invention substantially as claimed as set forth for claim 44 above.
Unluhisarcikli further discloses, wherein the assistive flexion torque is applied by an assistive lower-limb exoskeleton (FIG. 6 Actuated brace 602) comprising: a frame arranged to fit about at least one limb (FIG. 6 The frame as set forth in the annotated figure below); an actuation system arranged to apply a force to the frame (FIG. 6 The actuated brace 602 is driven by a brushless DC motor 609 coupled to a gearbox 610 and the torque generated by the motor is transferred to the knee joint by means of a push bar 611 and then a tension/compression load cell 612, which connects with the frame); and a controller, the controller arranged to actuate the actuation system at least during a stance phase, at an amplitude, a duration and a timing based on a knee hyperextension of the at least one limb (FIG. 8 The impedance controller implemented on ANdROS is illustrated in Figure 8, the resulting requested torque being passed to the ANdROS brushless motor and amplifier as set forth in [0063]-[0064]).
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Unluhisarcikli fails to explicitly disclose, wherein the controller includes a processor.
However, Roh teaches, wherein the controller includes a processor (Roh: As set forth in [0178}-[0179]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Unluhisarcikli to incorporate the teaching of Roh and include wherein the controller includes a processor (Roh: As set forth in [0178]-[0179]). Doing so provides a well-known component included in a controller for responding to and executing instructions (Roh: As set forth in [0179]).
Claims 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Unluhisarcikli (WO 2013049658 A1), in view of Roh (US 20150134080 A1).
Regarding claim 42, Unluhisarcikli discloses an assistive lower-limb exoskeleton (FIG. 3 An Active Knee Rehabilitation Orthotic System as set forth in the abstract, [0002], and [0019]) for mitigating or correcting knee hyperextension in a user (FIG. 1 As set forth in [0019]), the assistive lower-limb exoskeleton comprising: a frame arranged to fit about at least one limb (FIG. 6 The frame as set forth in the annotated figure below); an actuation system arranged to apply a force to the frame (FIG. 6 The actuated brace 602 is driven by a brushless DC motor 609 coupled to a gearbox 610 and the torque generated by the motor is transferred to the knee joint by means of a push bar 611 and then a tension/compression load cell 612, which connects with the frame); a controller, the controller arranged to actuate the actuation system at least during a stance phase, at an amplitude, a duration and a timing based on a knee hyperextension of the at least one limb (FIG. 8 The impedance controller implemented on ANdROS is illustrated in Figure 8, the resulting requested torque being passed to the ANdROS brushless motor and amplifier as set forth in [0063]-[0064]; regarding amplitude, the impedance controller uses the sensor data in a feedback loop that computes a desired knee angle and a desired torque as set forth in [0046]; the desired torque supplied to the motor being the resulting requested torque passed to the brushless motor and amplifier of the ANdROS after the measured torque 806 and the desired torque 805 are compared to produce a torque error 807 and a gain 808 is applied and compared with gravity and friction feedback measurements 809, regarding duration, one additional input to the impedance control loop is the desired knee angle, wherein the desired knee angle is generated from the estimation of gait phase, which include gait events such as heel strike and toe off which may be recorded to help normalize the time scale to one full gait cycle as set forth in [0069]-[0071], wherein the time scale of a full gait cycle, or even the velocity or cadence as set forth in [0076], would reflect a duration for which the flexion assistance should be implemented that is taken into consideration by the impedance control loop when determining the flexion assistance, and regarding timing, given the desired knee angle is generated from the estimation of gait phase based on a human-machine synchronization algorithm, this would be inclusive of an ideal reference trajectory that needs to be established, which accounts for walking velocity, cadence, and step length, as set forth in [0069] and [0076]-[0077], wherein the cadence would reflect a timing in which the flexion assistance should be implemented that is taken into consideration by the impedance control loop when determining the flexion assistance; based on knee hyperextension as set forth in [0019]; Sensors located at each joint measure joint angles, which are used for controls and gait monitoring as set forth in [0058], the sensor data is used by the impedance controller to compute a desired knee angle at the first rotatable knee joint and to command a torque at the second rotatable knee joint based in part on the desired knee angle as set forth in [0020]; the gate deviation targeted, and therefore identified, by the controller being represented by the initial sensor data, which could include that of knee hyper extension).
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Unluhisarcikli fails to explicitly disclose, wherein the controller includes a processor.
However, Roh teaches, wherein the controller includes a processor (Roh: As set forth in [0178}-[0179]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Unluhisarcikli to incorporate the teaching of Roh and include wherein the controller includes a processor (Roh: As set forth in [0178]-[0179]). Doing so provides a well-known component included in a controller for responding to and executing instructions (Roh: As set forth in [0179]).
Regarding claim 43, Unluhisarcikli as modified discloses the claimed invention substantially as claimed as set forth for claim 42 above.
Unluhisarcikli as modified further discloses further comprising at least one sensor arranged to determine at least one gait parameter (Sensors located at each joint measure joint angles, which are used for controls and gait monitoring as set forth in [0058]); wherein the controller is arranged to determine the amplitude, the duration and the timing based on the at least one gait parameter (FIG. 8 The data is further used in the impedance controller implemented on ANdROS, the resulting requested torque depending on the data obtained).
Conclusion
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/KEIRA EILEEN CALLISON/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785