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 .
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Woge (20200121478).
Regarding claim 1, Woge discloses a method for controlling a joint (1) of an orthopedic device (10) that comprises a first part (2), a second part (4), which is arranged on the first part (2) such that it can be pivoted about a pivot axis (1, where a joint is a pivot axis), an active actuator (32, where a motor is a type of actuator), a self-locking transmission (31, 33) and an electric control unit (321) for controlling the actuator (32, where a motor is a type of actuator), characterized in that during the method the electric control unit (321) controls the actuator (32, where a motor is a type of actuator) in such a way that the second part (4) moves according to forces acting on it externally ([0137], “the operation of the device 10 and driving mechanism 30 are regulated in response to sensor output”). As Woge discloses the structure of this joint, there must also be a generic method for controlling this structure.
Regarding claim 2, Woge discloses the method according to claim 1, characterized in that the joint (1) is an artificial ankle joint ([0101] “the joint may be… an ankle”), the first part (2) is a lower leg part (lower leg is part of an ankle) and the second part (4) a foot part (foot part would be arranged on lower leg part such that it can be pivoted around a pivot access, as “second part” is defined in claim 1). As Woge discloses the structure of this joint, there must also be a generic method for controlling this structure.
Regarding claim 3, Woge discloses the method according to claim 1, characterized in that the joint is an artificial knee joint ([0101] “the joint may be… a knee”), the first part (2) is an upper leg part (upper leg is part of a knee) and the second part (4) a lower leg part (lower leg part would be arranged on upper leg part such that it can be pivoted around a pivot access, as “second part” is defined in claim 1). As Woge discloses the structure of this joint, there must also be a generic method for controlling this structure.
Regarding claim 4, Woge discloses the method according claim 1, characterized in that at least one load measurand ([0105], “tendon tension”) is detected by means of at least one sensor ([0105], “sensor for feedback signal 22”) that allows a statement to be made about the load on the transmission (31, 33) and/or the static friction between the first transmission element (31) and the second transmission element (33) ([0105], “for detection and control of relative position between winding parts”), wherein the electric control unit (321) controls the actuator (32, where a motor is a type of actuator) depending on the load measurand detected ([0105], “to enable determination of the biasing of the bias organ”). As Woge discloses the structure of this joint, there must also be a generic method for controlling this structure.
Regarding claim 5, Woge discloses the method according to claim 1, characterized in that at least one force measurand ([0137], “tension of the biasing member”) is detected by means of at least one sensor (80, 81, 82) that allows a statement to be made about the external forces acting on the second part (4), wherein the electric control unit (321) controls the actuator (32, where a motor is a type of actuator) depending on the force measurand detected ([0137], “the alternate rolling in/pulling and movement following/rolling out/slacking of the tendons 20, 21 and the operation of the device 10 and driving mechanism 30 are regulated in response to sensor output given”). As Woge discloses the structure of this joint, there must also be a generic method for controlling this structure.
Regarding claim 6, Woge discloses the method according to claim 5, characterized in that a resulting movement and/or a resulting position of the second part (4) relative to the first part (2) is calculated from the force measurand ([0137], “tension of the biasing member”) detected and the electric control unit (321) controls the actuator (32, where a motor is a type of actuator) in such a way that the resulting movement is carried out and/or the resulting position is reached ([0137], “the alternate rolling in/pulling and movement following/rolling out/slacking of the tendons 20, 21 and the operation of the device 10 and driving mechanism 30 are regulated in response to sensor output given”). As Woge discloses the structure of this joint, there must also be a generic method for controlling this structure.
Regarding claim 12, Woge discloses a joint (1) for an orthopedic device (10) for carrying out a method according to claim 1 (FIG 1A).
Claim(s) 7-9, 11 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Woge (20200121478) in view of Herr (20200129314).
Regarding claim 7, Woge discloses the method according to claim 1, but fails to characterize in that the electric control unit (321) can be brought into a first mode and into a second mode, wherein in the first mode it controls the actuator (32, where a motor is a type of actuator) in such a way that the second part (4) is moved according to forces that act on it externally and do not do so in the second mode.
Herr discloses another orthopedic deice with a motor controlling movement of a joint. Herr teaches that the electric control unit (107) can be brought into a first mode ([0226]; upon initial contact of the toe, the actuators are driven in the dorsiflexion direction) and into a second mode ([0226] during foot-flat, the motors are turned off and the non-backdrivable actuators lock the joint in place), wherein in the first mode ([0226] Upon initial contact of the toe, the actuators are driven in the dorsiflexion direction) it controls the actuator (FIG 24) in such a way that the second part (5) is moved according to forces that act on it externally and do not do so in the second mode ([0226] During foot-flat, the motors are turned off).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Woge in view of Herr to include that the electric control unit can be brought into a first mode and into a second mode, wherein in the first mode it controls the actuator in such a way that the second part is moved according to forces that act on it externally and do not do so in the second mode, as taught by Herr, in order to conserve energy ([0022]).
Regarding claim 8, Woge as modified by Herr discloses the method according to claim 7, but fails to characterize in that the electric control unit (321) is brought into the first mode when predetermined movements, movement patterns and/or states of movement have been detected and/or when an actuation element has been actuated.
Herr teaches that the electric control unit (107) is brought into the first mode ([0226] Upon initial contact of the toe, the actuators are driven in the dorsiflexion direction) when predetermined movements, movement patterns and/or states of movement have been detected ([0226], “during foot-flat,” “upon initial contact of the toe”) and/or when an actuation element has been actuated ([0226], “Upon initial contact of the toe, the actuators are driven in the dorsiflexion direction”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Woge in view of Herr to include that the electric control unit is brought into the first mode when predetermined movements, movement patterns and/or states of movement have been detected and/or when an actuation element has been actuated, as taught by Herr, in order to improve device function ([0019]).
Regarding claim 9, Woge as modified by Herr discloses the method according to claim 7, but fails to characterize in that the electric control unit (321) is brought into the second mode when a predetermined criterion is met.
Herr teaches that the electric control unit (107) is brought into the second mode ([0226] Upon initial contact of the toe, the actuators are driven in the dorsiflexion direction) when a predetermined criterion is met ([0226], "upon initial contact of the toe", "Toe-off is detected by force measurement through the load cells").
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Woge in view of Herr to include that the electric control unit is brought into the second mode when a predetermined criterion is met, as taught by Herr, in order to improve device function ([0019]).
Regarding claim 11, Woge as modified by Herr discloses the method according to claim 9, but fails to characterize in that the predetermined criterion can be adjusted or changed.
Herr teaches that the predetermined criterion can be adjusted or changed ([0220], “[0220] For this gait mode, the ZCP would be set equal to a neutral or a small plantar flexed angle. In distinction, if the foot-strike angle is plantar flexed and the early stance torque is positive (dorsiflexion moment denoting a toe-strike), the ZCP would be set equal to a dorsiflexion angle appropriate for stair descent (˜10 degrees of dorsiflexion)”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Woge in view of Herr so that the predetermined criterion can be adjusted or changed, as taught by Herr, in order to improve device function ([0019]).
Regarding claim 13, Woge as modified by Herr discloses the joint (1) according to claim 12, but fails to characterize in that it has at least one sensor for detecting a load measurand, which comprises at least one expansion measuring strip, a spring force measure, a deformation sensor, a torque sensor, a pressure sensor and/or an axial load sensor.
Herr teaches the joint in that it has at least one sensor for detecting a load measurand, which comprises a spring force measure ([0214], “a strain gauge on each spring member 124 to allow for the measurement of the spring deflection,” where a strain gauge is a tool that can be used to measure spring force ), a deformation sensor ([0214], “a strain gauge on each spring member 124 to allow for the measurement of the spring deflection,” where deflection is a type of deformation), a torque sensor ([0220] “Foot-strike is detected based on force or torque measured by load cells”), and/or an axial load sensor ([0217], “Load cell detects force on actuators indicating foot-contact”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Woge in view of Herr so that it has at least one sensor for detecting a load measurand, which comprises a spring force measure, a deformation sensor, a torque sensor, and/or an axial load sensor as taught by Herr in order to improve device function ([0019]).
Regarding claim 14, Woge as modified by Herr discloses the joint according to claim 13, but fails to disclosed characterized in that it has at least one sensor for detecting the force measurand, which comprises at least one force sensor, a position sensor an inertial sensor and/or a gyroscope.
Herr teaches that it has at least one sensor for detecting the force measurand, which comprises at least one force sensor ([0217], “Load cell detects force on actuators indicating foot-contact,” where load is a force), a position sensor ([0021] “The at least one sensor can include a joint position sensor”), an inertial sensor ([0264], “using information from onboard sensors such as accelerometers or inertial measurement units”) and/or a gyroscope ([0220], “Sensors in the device such as… gyrospcopes”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Woge in view of Herr so it has at least one sensor for detecting the force measurand, which comprises at least one force sensor, a position sensor an inertial sensor and/or a gyroscope, as taught by Herr, in order to improve device function ([0019]).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Woge (20200121478) in view of Herr (20200129314), and further in view of James (5383939).
Woge as modified by Herr discloses the method according to claim 9, but fails to characterize in that the criterion is met when an angle between the second part (4) and the first part (2) leaves a predetermined angle range; when the predetermined movements, movement patterns and/or states of movement are not or are no longer detected; when an actuation element has been actuated and/or after the electric control unit (321) has been in the first mode for a predetermined period of time.
Herr teaches that the criterion is met when an angle between the second part (5) and the first part (16) leaves a predetermined angle range ([0220], “Near the point of foot-flat, the controller outputs zero motor current at a desired ankle spring equilibrium angle, as measured by an ankle joint encoder. This angle is called the zero-current position (ZCP)”); when the predetermined movements, movement patterns and/or states of movement are not or are no longer detected (“During foot-flat, the motors are turned off and the non-backdrivable actuators lock the joint in place”); and/or when an actuation element has been actuated ([0226], “during foot-flat”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Woge in view of Herr so the criterion is met when an angle between the second part and the first part leaves a predetermined angle range; when the predetermined movements, movement patterns and/or states of movement are not or are no longer detected as taught by Herr in order to improve device function ([0019]).
James teaches that the criterion is met after the electric control unit (107) has been in the first mode for a predetermined period of time (col 14, line 45, “As soon as the processor switches to state #7, a timer starts and measures the time which the load is present on the heel. After 1/3 of a second the processor switches to state #8 which commands the damper to allow knee joint flexion”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Woge in view of James so the criterion is met after the electric control unit (107) has been in the first mode for a predetermined period of time, as taught by James, in order to simulate knee action (col 3, line 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bartlett (WO 2021061950 A1) and Auberger (BR PI0617786 A2) disclose additional sensors for detecting a load measurand, as is relevant to claim 13.
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/R.F.N./Patent Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774