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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 2/10/2026 is acknowledged. Claims 20-22 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/10/2026. The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 6-8, 10-11, and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lenzi et al. (Pub. No.: US 2016/0074180 A1).
Lenzi discloses the following regarding claim 1: a method of operating a powered mobility assistance device (10) comprising the steps of: performing a gait cycle including stance control of a knee joint component of the powered mobility assistance device (paras. 0024-0026) during a stance substate of the gait cycle (paras. 0029-0038), and swing control of the knee joint component during a swing substate of the gait cycle (paras. 0029-0038), wherein multiple gait cycles of the stance control and the swing control are implemented for walking using the powered mobility assistance device (paras. 0029-0038); wherein the stance control comprises: reading a desired stance knee angle of the knee joint component that is preset into a control system of the powered mobility assistance device (paras. 0036-0038); detecting an actual stance knee angle of the knee joint component as measured by sensors (paras. 0025-0026, 0048) in the powered mobility assistance device (paras. 0036-0038); and measuring an error between the desired stance knee angle and the actual stance knee angle (paras. 0029-0045), and when the error between the desired stance knee angle and the actual stance knee angle exceeds a threshold error (paras. 0029-0045, as the torque and prosthesis are adjusted to the desired values because they will be beyond the operator’s threshold error), operating an actuator assembly (50) of the powered mobility assistance device to control the knee joint component to stabilize the knee joint component during the stance substate of the gait cycle (paras. 0022-0026, 0029-0038); and wherein the swing control comprises: reading a desired swing knee trajectory of the knee joint component that is preset into the control system of the powered mobility assistance device (paras. 0022-0026, 0036-0040), wherein a swing knee trajectory is defined as a pattern of knee flexion and extension of the knee joint component through the swing substate of the gait cycle (paras. 0036-0040, 0050-0053, as flexion and extension patterns are standard components of a walking gait); detecting an actual swing knee trajectory of the knee joint component as measured by the sensors (paras. 0025-0026, 0048) in the powered mobility assistance device (paras. 0036-0040); and measuring an error between the desired swing knee trajectory and the actual swing knee trajectory, and operating the actuator assembly of the powered mobility assistance device to control the knee joint component to adjust the actual swing knee trajectory toward the desired swing knee trajectory during the swing substate of the gait cycle (paras. 0029-0045).
Lenzi discloses the following regarding claim 3: the method of operating of claim 1, wherein the desired stance knee angle is a knee angle from 0º to 20º of knee flexion (Fig. 3; paras. 0049-0059).
Lenzi discloses the following regarding claim 6: the method of operating of claim 1, wherein the swing substate of the gait cycle includes an early swing substate characterized by knee flexion of the knee joint component (paras. 0029-0038), and a first error is measured between a desired knee angle of the knee joint component of the desired swing knee trajectory and an actual knee angle of the knee joint component of the actual swing knee trajectory at the initiation of the early swing substate (paras. 0029-0038); and the actuator assembly of the powered mobility assistance device is operated to control the knee joint component to adjust toward the desired swing knee trajectory during the early swing substate of the gait cycle by implementing the desired swing knee trajectory from the actual knee angle (paras. 0022-0026, 0029-0038).
Lenzi discloses the following regarding claim 7: the method of operating of claim 6, wherein the swing substate of the gait cycle further includes a late swing substate following the early swing substate (paras. 0029-0038) and characterized by knee extension of the knee joint component, and a second error is measured between a desired peak knee angle (at highest angle of able-bodied gait) of the knee joint component of the desired swing knee trajectory and an actual peak knee angle of the knee joint component of the actual swing knee trajectory at the initiation of the late swing substate (paras. 0022-0026, 0029-0038); and the actuator assembly of the powered mobility assistance device is operated to control the knee joint component to adjust the swing knee trajectory toward the desired swing knee trajectory during the late swing substate of the gait cycle by implementing the swing knee trajectory from the actual peak knee angle toward a desired stance knee angle at the end of the late swing substate (paras. 0022-0026, 0029-0038).
Lenzi discloses the following regarding claim 8: the method of operating of claim 7, wherein the desired swing knee trajectory includes a peak knee angle from 30º to 100º of knee flexion (Fig. 3; paras. 0049-0059).
Lenzi discloses the following regarding claim 10: the method of operating of claim 1, wherein the swing substate has a fixed duration, and the fixed duration is set based on a specified ratio of the duration of the swing substate to a duration of the stance substate based on representative stance substate duration measurements (Fig. 3; paras. 0049-0059).
Lenzi discloses the following regarding claim 11: the method of operating of claim 10, wherein the fixed duration is from 0.2 to 2 seconds (paras. 0047-0058).
Lenzi discloses the following regarding claim 13: the method of operating of claim 1, wherein a duration of the swing substate is set based on a specified ratio of the duration of the swing substate to a duration of the stance substate, and the duration of the swing substate adapts in real time based on a duration measurement of one or more previous stance substates (paras. 0047-0058).
Lenzi discloses the following regarding claim 14: the method of operating of claim 2, further comprising a neutral substate (interpreted as the stance phase) that is a transition from the stance substate to the swing substate, wherein during the neutral substate the resistive control element and the powered control element are inactive (paras. 0047-0059).
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) 2, 5, 9, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lenzi in view of Herr et al. (CA 2762265 A1; hereinafter “Herr”).
Lenzi discloses the limitations of the claimed invention, as described above. Lenzi further teaches the mobility assistance device further is operable in a free mode in which the knee joint component is in an unlocked state and the actuator assembly is maintained as inactive (paras. 0022-0026, 0029-0038). However, it does not explicitly recite a resistive control element that resists knee joint component rotation. Herr teaches that it is well known in the art that a prosthetic knee comprises means for controlling knee rotation and torque (pgs. 16-17, 26-27), for the purpose of providing the knee prosthesis with the desired gait movement needed for a particular patient. Herr teaches an actuator assembly in the stance control comprises combining operation of a resistive control element (130) that resists knee joint component rotation and a powered control element that powers knee joint component rotation to provide an output torque to stabilize the knee joint component during the stance substate (pgs. 15-18, 26-27). Herr further teaches operating the actuator assembly in the swing control comprises operating a powered control element (e.g., 132) that assists rotation of the knee joint component to provide an output torque to rotate the knee joint component to adjust the swing knee trajectory toward the desired swing knee trajectory during the swing substate (pgs. 15-18, 26-27). The resistive control element of Herr comprises operating a brake (130) in the actuator assembly to resist rotation of the knee joint component, and operating the powered control element comprises operating an actuator in the actuator assembly to provide additional resistance to rotation of the knee joint component to stabilize the knee joint component during the stance control (pgs. 15-18, 26-27). The brake is operable in a lock mode in which the actuator assembly operates to maintain the knee joint component in a locked state that substantially resists rotation of the knee joint component (pgs. 15-18, 26-27). It would have been obvious to one having ordinary skill in the art to modify the invention of Lenzi to comprise a brake resistive control element to control the knee rotation, as taught by Herr, in order to provide the knee prosthesis with the desired gait movement needed for a particular patient. Such a modification would be made with a reasonable expectation of success.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lenzi. Lenzi discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the value of the threshold error. The optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal threshold error needed to achieve the desired results and correct the patient’s gait. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the threshold error, would have been obvious at the time of applicant's invention in view of the teachings of Lenzi. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. Such a modification would be made with a reasonable expectation of success.
Claim(s) 15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lenzi in view of Fairbanks et al. (Pub. No.: US 2010/0023133 A1; hereinafter “Fairbanks”).
Lenzi discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite pressure sensors on a foot plate. Fairbanks teaches that it is well known in the art that a prosthetic knee comprises pressure sensors positioned in a foot plate of the mobility assistance device (para. 0006), and the neutral substate is initiated upon detecting the pressure sensors transitioning from being loaded toward being unloaded; and wherein the neutral substate is entered when it is detected from the pressure sensors that a center of pressure of a user's foot has advanced from a heel to a ball of the user's foot (paras. 0006, 0052-0059, 0098-0110). Fairbanks further teaches pressure sensors positioned in a foot plate of the mobility assistance device, and the neutral substate is initiated upon detecting the pressure sensors transitioning from being loaded toward being unloaded; and wherein the neutral substate is entered when it is detected from the pressure sensors that the pressure sensors are fully unloaded (paras. 0006, 0052-0059, 0098-0110). It would have been obvious to one having ordinary skill in the art to modify the invention of Lenzi to comprise a pressure sensors on a foot plate, as taught by Fairbanks, in order to provide a stable foot platform for the knee prosthesis with the desired gait movement. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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