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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/29/2025 has been entered.
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) 1-2, 6-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer (DE102014010938A1) in view of Holgate (WO2018/085014A1).
In regard to claim 1, Meyer discloses a prosthetic device for a lower extremity (fig 1), the prosthetic device comprising a prosthetic foot 2 and a lower-leg part 3 (proximal ankle joint) fastened to the prosthetic foot 2 (see fig 1),
and a device 7 (pivot) for manually adjusting (paragraph 27: manually or automatically adjustment) an orientation of the lower-leg part 3 (ankle joint is the lower part of a leg) relative to the prosthetic foot 2 (see fig 2), characterized in that an inertial angle sensor (9; paragraph 13 of translation: inertial angle sensor) serves to detect the orientation (9 is a position sensor/inertial angle) in space (an inertial angle sensor detects a location in space)
and is coupled to an output device 5 which outputs, in a manner identifiable by a user by way of an output signal (optical, acoustic or voice output; paragraph 9 of translation), the orientation of the lower-leg part in space (so prosthesis user knows which level heel height adjustment is currently present; paragraph 9 of translation) or the attainment of an orientation defined in advance (The claim does not specify in advance of what and accordingly this could be any point in time).
However, Meyer does not teach that the inertial angle sensor is arranged on the lower leg part.
Holgate teaches the inertial angle sensor is arranged on the lower leg part (20 is located on the lower leg part, proximal half of the ankle joint) to detect the orientation of the lower leg part in space [0014: detects kinematic states; 0015: radians] in order to control non-gait motions of an actuator in a prosthetic device (abstract) in order to control the orientation of an ankle joint [0033: output angle].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the sensor of Meyer on the shank instead of the foot (proximal ankle joint instead of distal) as taught by Holgate because this would be a functionally equivalent measurement since both sensors measure the inertial angle to control an ankle joint during a non-gait state and since both sensors are used in calibration of the ankle joint position [0037-0039]. MPEP 2144.06II
In regard to claim 2, discloses the limitations as discussed in the in the rejection of claim 1, and further discloses the inertial angle sensor 9 and the output device 5 are combined as a module and integrated in the prosthetic device or are detachably fastened thereto. (figure 10; module is defined as separate parts joined together to form a larger object; as shown in figure 10; inertial angle sensor and output device are both parts of the ankle joint)
In regard to claim 6, Meyer discloses the claim limitations as discussed in the rejection of claim 1, and further discloses the output device 5 is designed to output an optical, acoustic and/or tactile output signal. (paragraph 9: optical, acoustic or voice output)
In regard to claim 7, Meyer discloses the claim limitations as discussed in the rejection of claim 1, and further discloses the prosthetic foot 2 is mounted so as to be pivotable in a sagittal plane. (interpreted as dorsiflexion and plantarflexion; see fig 3-4, pivots about 7)
In regard to claim 8, Meyer discloses the claim limitations as discussed in the rejection of claim 1, and further discloses a deactivation device (switch, translation paragraph 13: switch which is folded by a mechanical actuator so that a circuit is opened or interrupted), which deactivates the inertial angle sensor (paragraph 13-14 of translation: depending on opening or closing of the circuit a corresponding signal is output) and/or the output device or the connection between the inertial angle sensor and the output device after the orientation defined in advance has been attained.
In regard to claim 9, Meyer discloses an adjustment device (ankle joint, figure 1) for manually adjusting (paragraph 27: manually or automatically adjustment) an orientation of a lower-leg part relative 3 to a prosthetic foot 2 of a prosthetic device of a lower extremity (see fig 3-4),
wherein the adjustment device (ankle joint) comprises an inertial angle sensor (9; paragraph 13 of translation: inertial angle sensor) which detects the orientation of the in space (so prosthesis user knows which level heel height adjustment is currently present; paragraph 9 of translation; this is how an inertial angle sensor works)
and which is coupled to an output device 5 which outputs, in a manner identifiable by a user by way of an output signal, the orientation of the lower-leg in space (so prosthesis user knows which level heel height adjustment is currently present; paragraph 9 of translation) or the attainment of an orientation defined in advance (This could be in advance of anything since not specified).
However, Meyer does not teach that the inertial angle sensor is arranged on the lower leg part.
Holgate teaches the inertial angle sensor is arranged on the lower leg part (20 is located on the lower leg part, proximal half of the ankle joint) to detect the orientation of the lower leg part in space [0014: detects kinematic states; 0015: radians] in order to control non-gait motions of an actuator in a prosthetic device (abstract) in order to control the orientation of an ankle joint [0033: output angle].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the sensor of Meyer on the shank instead of the foot (proximal ankle joint instead of distal) as taught by Holgate because this would be a functionally equivalent measurement since both sensors measure the inertial angle to control an ankle joint during a non-gait state and since both sensors are used in calibration of the ankle joint position [0037-0039]. MPEP 2144.06II
In regard to claim 10, Meyer discloses the adjustment device as claimed in claim 9, and further discloses the output device 5 is designed to output an optical, acoustic and/or tactile output signal. (paragraph 9: optical, acoustic or voice signal)
In regard to claim 11, Meyer discloses the adjustment device (ankle) as claimed in claim 9 and further discloses a fastening device (interpreted under 112f as screws) for securing to a prosthetic device (socket) is arranged or formed on the adjustment device (ankle; see screws on 4 which attach as a standard female connection to standard male connection 31 of the ankle joint, figs 1-2).
In regard to claim 12, Meyer discloses a method for manually adjusting (paragraph 27: manually or automatically adjustment) an orientation of a lower-leg part 3 of a prosthetic device of a lower extremity (fig 1) relative to a prosthetic foot 2 fastened to the lower-leg part (fig 3-4; abstract)
The prosthetic device comprising an adjustment device (ankle joint, fig 1, 10) with an inertial angle sensor (9; paragraph 13 of translation: inertial angle sensor) that is arranged on the prosthetic device (fig 1, sensor 9 is on the prosthetic limb) and coupled to an output device 5 (fig 1), the method comprising:
Detecting with the inertial angle sensor 9 the orientation of the lower-leg part 3 in space (9 is a position sensor/inertial angle sensor; since 3 is attached to the lower ankle 5, the orientation in space of 4 is also detected, at least when the ankle is in a neutral position),
wherein a reference orientation of the lower-leg part 3 in space is set for a user and an attainment signal of the reference orientation is set in advance and is output in a manner identifiable by a user by way of an output signal (tactile, optical or acoustic signal; different outputs for different heel heights; paragraph 9 of translation; assign heel heights to respective heel height signals; the heel height is the reference orientation set in advance; the heel height will correspond to the orientation of the lower leg part via the ankle angle) and
adjusting the orientation based on the detected orientation (see sensor 9, fig 8). (paragraphs 23-24 of the translation: automatic detection and transmission; motor, displacement takes place in dependence on the detected heel height so that always and automatic adjustment of the position of the foot is done).
However, Meyer does not teach adjusting the orientation of the lower leg part based on the detected orientation of the lower leg part specifically or that the inertial angle sensor is arranged on the lower leg part.
Holgate teaches the inertial angle sensor is arranged on the lower leg part (20 is located on the lower leg part, proximal half of the ankle joint) to detect the orientation of the lower leg part in space [0014: detects kinematic states; 0015: radians] in order to control non-gait motions of an actuator in a prosthetic device (abstract) in order to control the orientation of an ankle joint [0033: output angle] and the sensor 20 detects the orientation of the lower leg part [0010: angular position or linear position in a coordinate frame] on a lower leg part 16 to control an ankle joint [0008].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the sensor of Meyer on the shank instead of the foot (proximal ankle joint instead of distal) as taught by Holgate because this would be a functionally equivalent measurement since both sensors measure the inertial angle to control an ankle joint during a non-gait state and in calibration of the ankle joint position [0037-0039]. MPEP 2144.06II
In regard to claim 13, Meyers discloses the method as claimed in claim 12, and further discloses adjusting the orientation adjusting the orientation in an applied (interpreted as best understood to refer to the prosthesis being worn by the user) or an applied and loaded state of the prosthetic device (paragraph 17 of translation: adjustment of heel height is usually under load)
However, Meyers does not teach adjusting the orientation of the lower leg part based on the detected orientation of the lower leg part specifically.
Holgate teaches using a sensor 20 which detects the orientation of the lower leg part [0010: angular position or linear position in a coordinate frame] on a lower leg part 16 to control an ankle joint [0008].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the sensor of Holgate in place of the sensor of Meyer through functional equivalents since both sensors are used to control an ankle joint and in calibration of the ankle joint position [0037-0039]. MPEP 2144.06II
In regard to claim 14, Meyer discloses the method as claimed of claim 12 and further discloses adjusting the orientation comprises adjusting the orientation automatically for each change in prosthetic foot, for each change in heel height or following an activation signal.
The claim is interpreted to mean the heel height is automatically adjusted (paragraphs 23-24 of the translation: automatic detection and transmission; motor, displacement takes place in dependence on the detected heel height so that always and automatic adjustment of the position of the foot is done)
However, Meyers does not teach adjusting the orientation of the lower leg part based on the detected orientation of the lower leg part specifically.
Holgate teaches using a sensor 20 which detects the orientation of the lower leg part [0010: angular position or linear position in a coordinate frame] on a lower leg part 16 to control an ankle joint [0008].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the sensor of Holgate in place of the sensor of Meyer through functional equivalents since both sensors are used to control an ankle joint and in calibration of the ankle joint position [ 0037-0039]. MPEP 2144.06II
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer (DE102014010938A1) in view of Holgate (WO2018/085014A1) and further in view of Aigner (WO2019/025838A1).
In regard to claims 4-5, Meyer meets the claim limitations as discussed in the rejection of claim 1, but does not teach a load sensor.
Aigner teaches a load sensor 4 is arranged on the prosthetic device (on the foot as shown in figure 1) and is coupled to the output device (stimulators 7a,b) in such a way that the output signal is output if a load is detected (vibrates as soon as the pressure sensor received a pressure signal at the corresponding sole area; paragraph 8 of translation);
wherein the load sensor 4 is designed as an axial force sensor, pressure sensor (pressure sensor; paragraph 8 of translation) or torque sensor.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the load sensor and additional output device of Aigner in the invention of Meyer because this allows information about the gait to be transmitted to the user (abstract) and to replicate feeling from the missing foot (paragraph 30 of translation: in order to reproduce the foot feeling as authentically as possible)
Response to Arguments
In regard to the objection of claim 14, the applicant’s arguments are found convincing and the objection is withdrawn.
In regard to the 102(a)(1) rejection of claims 1-3, 6-14 as anticipated by Meyer (DE102014010938A1), the applicant’s arguments have been fully considered. The applicant argues that the instant invention addresses the disadvantage of setting the heel height for each individual shoe which uses a relative angle between a foot and leg by using a relative space measurement of the lower leg part and not the lower leg part relative to the foot. The applicant argues this avoids storing multiple relative angles for various shoes. While the claims are read in light of the specification, the specification is not read into the claims. The claim language does not require that various heel heights are not stored. The applicant argues that prior art Meyers detects the position of the foot. For example, “lower leg part” is very broad and does not actually refer to a specific part of the leg. While relevant arguments have been addressed, all arguments are directed towards new claim limitations which have been addressed above.
In regard to the 103(a) rejection of claims 12-14 as unpatentable over Meyer in view of Holgate (WO2018/085014A1), no further arguments have been submitted.
In regard to the 103(a) rejection of claims 4-5 as unpatentable over Meyer in view of Aigner (WO2019/025838A1), no further arguments have been submitted.
It should be noted that the currently amended claim language does not overcome references Holgate (WO2018/085014A1) and Auberger (EP3035895) from the international search report. “Adjusting the orientation” in the claims could be read as simply changing the position of the ankle joint during the gait cycle since the claims do not require locking the ankle joint in the desired heel height position. It is suggested to amend the claim language accordingly for purposes of compact prosecution. Further, it is suggested to amend the claims to make it clear that the system is not storing various heel heights. For example, the shank angle is only being compared to a vertical vector (figure 1 of the instant invention).
Conclusion
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774