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 .
Status of Claims
Claims 1-5, 7-9, 11, 12, 14-17 are pending and examined below.
Response to Arguments
The remarks of 12/17/2025 have been fully considered but they are not persuasive.
Applicant argues that the prior art doesn't explicitly teach or disclose all of the elements of amended claim 1. Applicant specifically argues the following claim language:
“a distal/tibial nerve stimulation electrode, and a sural nerve stimulation electrode”
This argument is moot in light of the new 103 rejection below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 and 7-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1-7 and 7-17, Claim 1 recites “a distal/tibial nerve stimulation electrode”. This renders the claim indefinite as it is unclear where the nerve stimulation electrode is placed. Does this nerve stimulation electrode stimulate either a distal nerve or the tibial nerve? Or does it stimulate the distal aspect of the tibial nerve (i.e. distal tibial or distal-tibial as listed in the specification). Examiner will assume the later based on the specification. Appropriate correction is required. Claims 2-7 and 7-17 are also rendered indefinite due to their dependency on claim 1.
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, 8, 9, 12, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0160522 (‘522) in view of US 2014/0088729 (‘729) in view of US 2016/0331561 (Raspopovic) in view of US 2024/0225859 (Podhola)
Regarding claim 1, ‘522 discloses a powered prosthetic foot system (Fig. 1A) comprising:
a support pylon (Fig. 1B, 102)
a spring dorsiflexion-type passive foot (Fig. 3A, 105) attached at a lower end of the support pylon with an articulating ankle joint (¶0036, wherein ankle 103 is connected to 105)
a powered linear actuator (Fig. 7C, 129) extending between a middle portion of the support pylon and an extension from a heel of the foot (see Fig. 2A, wherein 129 extends between middle portion of 102 and 107);
a closed-loop bi-directional control and neural intuitive feedback system comprising (see below):
a plantar pressure sensor (¶0068, “force sensor”) mounted to a bottom of the foot (¶0068, wherein “heel strike is detected using a force sensor on the J-spring” corresponds to mounted on the bottom of the foot);
an accelerometer (¶0035, “accelerometer”);
an ankle joint angle sensor (¶0035, “joint angular sensor”);
electromyographic sensor electrodes (¶0068, “electromyographic electrodes”)
a microcontroller unit (¶0068, “microprocessor”) including a serial data interface (¶0068, wherein the microprocessor includes a serial data interface) in communication with said angle sensor and said accelerometer (¶0068, “wherein intrinsic and extrinsic sensors inform the microprocessor” corresponds with in communication with angle sensor and accelerometer), analog-to-digital converters (¶0035, “analog to digital converters” in communication with said plantar pressure sensor and said EMG electrodes, said MCU further including a processor (¶0035, “micro-processors”), and current driver (¶0052, wherein 151 corresponds to current driver) in communication with said linear actuator and said neural stimulator, and
a power system to power the control and feedback system and the motor (¶0052, “custom five cell lithium polymer battery pack 154”), including a rechargeable battery (Fig. 1, battery 114)
said MCU (¶0068, “microprocessor”) including a programmed system application which is configured for controlling the feedback system (¶0068, wherein the microprocessor board controls the feedback system) and linear actuator (Fig. 7C. 129) to generate plantarflexion of the foot by extension and retraction of the linear actuator based on inputs received from the pressure sensor, the accelerometer, the ankle joint angle sensor, the EMG sensor electrodes (¶0050, wherein 129 uses sensor inputs to power plantarflexion)
‘522 doesn’t explicitly teach or disclose a 2-channel neural amplifier, band pass filters for the EMG sensor electrodes, DC-DC converters, or a battery recharging circuit. ‘However, ‘522 incorporates US 2014/0088729 (‘729) by reference (¶0080-0083).
‘729 discloses a 2-channel neural amplifier (¶0426, wherein “signals were amplified” corresponds to a 2-channel neural amplifier”), band pass filters for the EMG sensor electrodes (¶0426, “EMG data was band-pass filtered”), DC-DC converters (Fig. 30, “DC to DC”), and a battery recharging circuit (Fig. 30, wherein the circuit show acts to recharge 48V battery pack)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the powered prosthetic foot of ‘522 with an amplifier and band pass filter, as taught by ‘729, in order to make the EMG signals usable for a prosthetic control system while eliminating noise.
‘522 doesn’t explicitly teach or disclose nerve stimulation electrodes, a 2-channel neural stimulator, or wherein the system application is configured to deliver sensory feedback to the user via said nerve stimulation electrodes based on said inputs. ‘729 doesn't explicitly teach or disclose nerve stimulation electrodes, a 2-channel neural stimulator, or wherein the system application is configured to deliver sensory feedback to the user via said nerve stimulation electrodes based on said inputs
Raspopovic discloses a neuro-prosthetic system comprising:
a 2-channel neural stimulator (¶0059, wherein the “stimulator” has two independent channels)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify ‘522 in view of ‘729 with nerve stimulation electrodes and a neural stimulator, as taught by Raspopovic, in order to restore a sense of proprioception to the user post-amputation.
‘522 doesn't explicitly teach or disclose a distal/tibial nerve stimulation electrode, and a sural nerve stimulation electrode. ‘729 doesn't explicitly teach or disclose a distal/tibial nerve stimulation electrode, and a sural nerve stimulation electrode. Raspopovic discloses a system application is configured to deliver complimentary sensory feedback to the user via nerve stimulation electrodes (¶0013, wherein complimentary sensory feedback is delivered to user via electrodes) which includes at least the tibial nerve (¶0058, “tibial nerve” in the case of lower limb TMR). Raspopovic doesn't explicitly teach or disclose a sural nerve stimulation electrode.
Podhola discloses a prosthesis comprising a sural nerve stimulation electrode (¶0002, “sural”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system application and nerve stimulation electrodes of ‘522 in view of ‘729 in view of Raspopovic to include a sural nerve stimulation electrode, as taught by Podhola, in order to stimulate proprioceptive sensory feedback (¶0002).
Regarding claim 8, ‘522 disclose an MCU and an accelerometer (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the MCU and the accelerometer (¶0559, “three axis accelerometer) classifies the status of walking from other leg movements in real time
‘729 discloses an MCU (¶0558, “microprocessor”) and an accelerometer (¶0559, “three axis accelerometer”) which classifies the status of walking from other leg movements in real time (¶0559, wherein “swing phase” corresponds to classifying a status of walking in real time)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the MCU and accelerometer of ‘522 to classify the status of walking in real time, as taught by ‘729, in order to sync the control of the prosthesis with the movement of the user.
Regarding claim 9, ‘522 discloses an MCU (see rejection of claim 1) but doesn’t explicitly teach or disclose wherein the MCU and plantar pressure sensor are configured to measure the gait phase in real time.
‘729 discloses an MCU (¶0558, “microprocessor”) and plantar pressure sensor (Fig. 31, six total force sensors) that are configured to measure the gait phase in real time (¶0090, wherein force sensors are configured for this intended use because they determine stance and swing phase)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the MCU of ‘522 with a plantar pressure sensor, as taught by ‘729, in order to determine when the prosthetic foot has contacted the ground.
Regarding claim 12, ‘522 discloses EMG input (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the EMG input is measured from the ankle extensor/flexor muscles
‘729 discloses wherein the EMG input is measured from the ankle extensor/flexor muscles (¶0366, wherein soleus and gastrocnemius correspond to ankle extensor/flexor muscles)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the EMG inputs of ‘522 to measure the ankle extensor/flexor muscles, as taught by ‘729, in order to provide intuitive control of the prosthetic foot.
Regarding claim 15, ‘552 discloses wherein the microcontroller unit (¶0044, electronic board 113) is configured to adjust an active duration(phase) of the linear actuator motor (¶0044, wherein 113 controls liner actuator 125), based on the gait phase (¶0045, wherein late swing phase corresponds to controlling the linear actuator in regards to the gait phase)
Regarding claim 16, ‘522 disclose a microcontroller unit (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the MCU adjusts stimulation parameters to adjust artificial sensory feedback. ‘729 doesn't explicitly teach or disclose wherein the MCU adjusts stimulation parameters (i.e., amplitude, frequency, and phase of stimulation) to adjust artificial sensory feedback.
Raspopovic discloses wherein the microcontroller unit (¶0062, microprocessor) adjusts stimulation parameters (¶0059, wherein amplitude, pulse width, and frequency correspond to stimulation parameters) to adjust artificial sensory feedback (¶0065, wherein the microprocessor adjusts the parameters of the stimulator)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the microcontroller unit of ‘522 in view of ‘729 to adjust stimulation parameters, as taught by Raspopovic, in order to maintain an appropriate level of feedback to the user.
Claim(s) 2 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0160522 (‘522) in view of US 2014/0088729 (‘729) in view of US 2016/0331561 (Raspopovic) in view of US 2024/0225859 (Podhola), as applied to claims above, and further in view of US 2016/0354216 (Hugate)
Regarding claim 2, ‘522 discloses a support pylon (see rejection of claim 1 above) but doesn’t explicitly teach or disclose wherein the support pylon includes a main support portion with the central conduit extending therethrough, and a porous cladding layer on the upper end. ‘729 doesn't explicitly teach or disclose a main support portion with the central conduit extending therethrough, and a porous cladding layer on the upper end. Raspopovic doesn't explicitly teach or disclose a main support portion with the central conduit extending therethrough, and a porous cladding layer on the upper end. Podhola doesn't explicitly teach or disclose a main support portion with the central conduit extending therethrough, and a porous cladding layer on the upper end.
Hugate discloses a support pylon (Fig. 1) formed as a one-piece structure (see MPEP 2144, wherein making a component integral is an obvious engineering choice) which includes a main support portion (Fig. 1, 7) with the continuous central conduit (Fig. 1, 8) extending therethrough, and a porous cladding layer on the upper end (Fig. 1, wherein the cross-hatched regions represent a highly porous material – corresponding to a porous cladding layer, ¶0021)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to attach the prosthetic foot of ‘522 in view of ‘729 in view of Raspopovic in view of Podhola with the support pylon of Hugate, as taught by Hugate, in order to avoid fit or comfort issues that are associated with a more typical prosthetic socket
Regarding claim 7, ‘522 doesn’t explicitly teach or disclose an external computing system. ‘729 doesn’t explicitly teach or disclose an external computing system.
Raspopovic discloses an external computing system (¶0062, “microprocessor”) including a wireless transceiver (¶0046, wherein “wireless” connection corresponds to wireless transceiver), said closed-loop bi-directional control and neural intuitive feedback system further comprising a wireless transceiver for communicating with said external computing system (¶0046, wherein “wireless” connection corresponds to wireless transceiver), said external computer system including a system application configured for receiving operational (¶0064, “voluntary intention”) and feedback data, evolving and updating operational parameters of linear actuator control and stimulation based on EMG, pressure sensory output, accelerometer output, ankle joint angle output (¶0046, “pressure/force/angular/position sensors”), and delivering said parameters back to the control and feedback system (¶0064, wherein the microprocessor receives the signals to update control parameters).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the powered prosthetic foot system of ‘522 in view of ‘729 with an external computing system, as taught by Raspopovic, in order to restore sensory feedback to a prosthetic limb (Raspopovic, ¶0064)
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0160522 (‘522) in view of US 2014/0088729 (‘729) in view of US 2016/0331561 (Raspopovic) in view of US 2024/0225859 (Podhola) in view of US 2016/0354216 (Hugate), as applied to claims above, and further in view of US 2024/0000572 (Williams)
Regarding claim 3, ‘522 doesn't explicitly teach or disclose wherein an outer surface of the pylon has barbed or grooved surface features to maximize the surface area of contact with the outer porous titanium cladding. ‘729 doesn't explicitly teach or disclose wherein an outer surface of the pylon has barbed or grooved surface features to maximize the surface area of contact with the outer porous titanium cladding. Raspopovic doesn't explicitly teach or disclose an outer surface of the pylon has barbed or grooved surface features to maximize the surface area of contact with the outer porous titanium cladding. Podhola doesn't explicitly teach or disclose an outer surface of the pylon has barbed or grooved surface features to maximize the surface area of contact with the outer porous titanium cladding. Hugate doesn't explicitly teach or disclose an outer surface of the pylon has barbed or grooved surface features to maximize the surface area of contact with the outer porous titanium cladding
Williams discloses an outer surface of the pylon (Fig. 1, wherein 100 corresponds to pylon) has barbed or grooved surface features (Fig. 1, 120) to maximize the surface area of contact with the outer porous titanium cladding (Fig. 1, wherein 120 is configured for this intended use)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the support pylon of ‘522 in view of ‘729 in view of Raspopovic in view of Podhola in view of Hugate with a barbed surface, as taught by Williams, in order to increase the surface area and provide better fixation within the bone.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0160522 (‘522) in view of US 2014/0088729 (‘729) in view of US 2016/0331561 (Raspopovic) in view of US 2024/0225859 (Podhola) in view of US 2016/0354216 (Hugate), as applied to claims above, and further in view of US 2016/0331422 (Al Muderis)
Regarding claim 4, ‘522 discloses a support pylon (see rejection of claim 1) but doesn't explicitly teach or disclose a variable transversal cross section along a tube length and an outer part of the conduit has a conical shape with oval cross-section transversal to the longitudinal axis of the conduit. ‘729 doesn't explicitly teach or disclose a variable transversal cross section along a tube length and an outer part of the conduit has a conical shape with oval cross-section transversal to the longitudinal axis of the conduit. Raspopovic doesn't explicitly teach or disclose a variable transversal cross section along a tube length and an outer part of the conduit has a conical shape with oval cross-section transversal to the longitudinal axis of the conduit. Podhola doesn't explicitly teach or disclose a variable transversal cross section along a tube length and an outer part of the conduit has a conical shape with oval cross-section transversal to the longitudinal axis of the conduit. Hugate doesn't explicitly teach or disclose a variable transversal cross section along a tube length and an outer part of the conduit has a conical shape with oval cross-section transversal to the longitudinal axis of the conduit.
Al Muderis discloses a pylon that has a variable transversal cross section along a tube length (¶0089, wherein the transition from a triangular to a round cross-section corresponds to a “variable transversal cross section”) and an outer part of the conduit has a conical shape with oval cross-section transversal to the longitudinal axis of the conduit (Fig. 16, wherein 291 has a conical shape with an oval transverse cross-section)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the pylon of ‘522 in view of ‘729 in view of Raspopovic in view of Podhola in view of Hugate with a variable cross-section and a conical shaped conduit with an oval cross section, as taught by Al Muderis, in order to provide secure fixation of the pylon within the residual bone of the patient.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0160522 (‘522) in view of US 2014/0088729 (‘729) in view of US 2016/0331561 (Raspopovic) in view of US 2024/0225859 (Podhola) in view of US 2016/0354216 (Hugate), as applied to claims above, and further in view of US 2007/0071788 (Pitkin)
Regarding claim 5, ‘522 doesn't explicitly teach or disclose wherein inner walls of the central conduit have a coating comprising submicron layer of pure silver or other antimicrobial coating. ‘729 doesn't explicitly teach or disclose wherein inner walls of the central conduit have a coating comprising submicron layer of pure silver or other antimicrobial coating. Raspopovic doesn't explicitly teach or disclose wherein inner walls of the central conduit have a coating comprising submicron layer of pure silver or other antimicrobial coating. Podhola Raspopovic doesn't explicitly teach or disclose wherein inner walls of the central conduit have a coating comprising submicron layer of pure silver or other antimicrobial coating. Hugate doesn't explicitly teach or disclose wherein inner walls of the central conduit have a coating comprising submicron layer of pure silver or other antimicrobial coating.
Pitkin discloses a skin integrated device (Fig. 1) coated with submicron layer of pure silver or other antimicrobial coating (¶0024, “intermittent layer of fine silver”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the inner walls of the central conduit of the support pylon of ‘522 in view of ‘729 in view of Raspopovic in view of Podhola in view of Hugate with a submicron layer of pure silver, as taught by Pitkin, in order to prevent infection of the implant after implantation.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0160522 (‘522) in view of US 2014/0088729 (‘729) further in view of US 2016/0331561 (Raspopovic), in view of US 2024/0225859 (Podhola), as applied to claims above, and further in view of US 2011/0295385 (‘385)
Regarding claim 11, ‘522 discloses an MCU (see rejection of claim 1) and a motor (see rejection of claim 1) but doesn't explicitly teach or disclose the MCU is configured to measure motor output torque based on current consumption. ‘729 doesn't explicitly teach or disclose the MCU is configured to measure motor output torque based on current consumption. Raspopovic doesn't explicitly teach or disclose the MCU is configured to measure motor output torque based on current consumption. Podhola doesn't explicitly teach or disclose the MCU is configured to measure motor output torque based on current consumption
‘385 discloses an ankle foot prosthesis wherein the MCU is configured to measure motor output torque based on current consumption. (¶0003, wherein the equation is solved for motor torque below with kt = a motor torque constant)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the MCU and motor of ‘522 in view of ‘729 in view of Raspopovic in view of Podhola to determine motor torque by using the current consumption, as taught by ‘385, in order to provide an accurate measure of motor torque to inform the control system.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0160522 (‘522) in view of US 2014/0088729 (‘729) in view of US 2016/0331561 (Raspopovic) in view of US 2024/0225859 (Podhola), as applied to claims above, and further in view of US 2010/0113980 (‘980)
Regarding claim 14, ’522 discloses an MCU (see rejection of claim 1) but doesn’t explicitly teach or disclose wherein the MCU adjusts torque using PWM duty factor. ‘729 doesn’t explicitly teach or disclose wherein the MCU adjusts torque using PWM duty factor. Raspopovic doesn’t explicitly teach or disclose wherein the MCU adjusts torque using PWM duty factor. Podhola doesn’t explicitly teach or disclose wherein the MCU adjusts torque using PWM duty factor.
‘980 discloses a powered prosthetic foot system comprising a wherein the MCU (¶0294, controller 1762) unit adjusts torque used for the active ankle joint, using PWM duty factor (¶0294, wherein “three-phase pulse width modulation signals” corresponds to PWM duty factor).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the program the MCU of ‘522 in view of ‘729 in view of Raspopovic in view of Podhola to adjust torque with PWM duty factor, as taught by ‘980, in order to efficiently power the ankle without resistive losses.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0160522 (‘522) in view of US 2014/0088729 (‘729) in view of US 2016/0331561 (Raspopovic) in view of US 2024/0225859 (Podhola), as applied to claims above and further in view of US 2006/0195197 (Clausen)
Regarding claim 17, ‘522 discloses a powered prosthetic foot system (see rejection of claim 1) but doesn't explicitly teach or disclose a dorsal contact pressure sensor mounted on the top of the foot. ‘729 doesn't explicitly teach or disclose a dorsal contact pressure sensor mounted on the top of the foot. Raspopovic doesn't explicitly teach or disclose a dorsal contact pressure sensor mounted on the top of the foot. Podhola disclose stimulating the sural nerve (see rejection of claim 1 above) but doesn't explicitly teach or disclose a dorsal contact pressure sensor mounted on the top of the foot
Clausen discloses a system for monitoring gait dynamics (Fig. 10, 38) comprising a dorsal contact pressure sensor (Fig. 10, force sensor 38) mounted on the top of the foot (see Fig. 10, wherein 38 is mounted to top surface of foot 30) to trigger stimulation of the sural nerve and evoke a stumbling response when a dorsum of the prosthetic foot contacts an external object (Fig. 10, wherein 38 is configured for this intended use because it can be attached to external electronics)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the prosthetic foot and stimulators of ‘522 in view of ‘729 in view of Raspopovic in view of Podhola with a dorsal pressure sensor, as taught by Clausen, in order to read when there are undesirable forces exerted on the top surface of the foot (e.g. when catching the foot on an obstacle when walking or climbing steps)
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774