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 .
Claim Interpretation
Regarding Claim 1 & 21
The Specification of the Applicant as originally filed discloses the accelerometer as a secondary sensor (Para 0046). This is understood that the sensor is two parts 1) one an accelerometer capable of sensing the changing position and 2) another sensor for detecting the electrostatic from the wires (Para 0036). As stated before, an accelerometer cannot directly detect noise. An accelerometer can detect/measure acceleration. The computer system is disclosed as performing the detection of noise. Para 0047 of the Specification of the Applicant as originally filed, states:
the computing system 4 can then identify time periods during which the actuator 10 is being displaced above a threshold velocity. If the actuator 10 is moving above a predetermined threshold velocity, then the computing system 4 can filter out signals or data obtained during those time intervals because the data or information obtained during those time intervals have a high likelihood of suffering from noise or interference
The Specification supports the accelerometer as a secondary sensor and another sensor for detecting the electrostatic friction noise. In Para 0036, the Applicant discloses that other configurations to identify the noise or interference experienced by the wires are known to one of ordinary skill in the art. This disclosure further supports the Examiner’s position that the sensor for detecting both electrostatic friction noise and changeable position is not disclosed. Only known prior art sensors for detecting noise or interference experience by only the wires is.
Specifically Para 0058 discloses how the signal from the sensing wires represents the deflection sensing from the wires as a dashed line in Figure 9A. Figure 9B is discloses how the dashed like from Figure 9A is then used to filter the signal and to identify region of deflection noise energy. The accelerometer for detecting position is not disclosed as to how it detects electrostatic noise from the wire. The disclosure does teach many different sensor embodiments for the detection of electrostatic noise from the wire and many sensor embodiments for the detection of changeable position.
A similar Claim Interpretation applies to Claim 21.
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) 1-4, 6, 10-14 & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diolaiti et al. (W/O2019/074786 A1; enclosed herein) and further in view of Carter et al. (W/O 2017/136599 A1; enclosed herein).
Claim 1: Diolaiti teaches –
A probe assembly [a medical instrument mounted on an insertion assembly] (Para 0052, Figure 3A&B, Element 300) comprising:
a probe [elongate device] (Figure 3A, Element 310) including a distal tip [distal end] (Figure 3A&B, Element 318) with a plurality of electrodes [electrosurgical electrodes] (Para 0046; Para 0052 discloses a medical instrument and Para 0046 discloses the medical instrument as electrosurgical electrodes) and a plurality of wires [Medical instrument 226 may additionally house cables, linkages, or other actuation controls (not shown) that extend between its proximal and distal ends to controllably the bend distal end of medical instrument 226] (Para 0047 and See Figure 2A)
a handle body [instrument carriage] (Figure 3A&B, Element 306) [Instrument carriage 306 may be a component of a teleoperational manipulator assembly (…102) that couples to point gathering instrument 304 to control…motion of a distal end 318 of an elongate device 310] (Para 0052) [teleoperational manipulator assembly 102 of FIG. 1 may be replaced by direct operator control…the direct operator control may include various handles and operator interfaces for hand-held operation of the instrument] (Para 0051)
Examiner’s Note: The instrument carriage is a component of the handle.
an actuator [actuators, such as servomotors] (Para 0052) moveable relative to the handle body [Position measuring device 320 may include resolvers, encoders, potentiometers, and/or other sensors that determine the rotation and/or orientation of the actuators controlling the motion of instrument carriage 306 and consequently the motion of instrument body 312] (Para 0054),
the actuator being configured to displace the distal tip during a first time period [actuators controlling the motion of instrument carriage 306 and consequently the motion of instrument body 312] (Para 0054); and
a sensor (Figure 3A, Element 320 & 314) within the handle body [instrument carriage] (Figure 3A&B, Element 306),
Examiner’s Note: Element 320 (position measuring device) is disclosed in Figure 3A as being in Element 306 (instrument carriage).
the sensor including:
an actuator movement sensing element [position measuring device 320 provides information about the position of instrument body 312 as it moves on insertion stage 308 along an insertion axis A] (Para 0054) configured to detect a changeable position of the actuator relative to the handle body during the first time period (compare the position of Element 318 between Figures 3A&B), and
a noise sensing element configured to pick up noise generated by movement of the actuator [the one or more force sensors may include a first force sensor located at an input of a low backlash drivetrain used to actuate the device and a second force sensor located at an output of the drivetrain] (Para 0097),
the noise being caused by friction [one or more proximal force sensors may be used to measure the amount of force resisting the desired motion in the device being monitored] (Para 0097) [friction force is determined using one or more models of friction for the device being monitored and the position and/or velocity of the device being monitored] (Para 0095) [an amount of friction in the medical device] (Claim 11),
the sensor being configured to communicate the detected changeable position [position and/or velocity of the device being monitored] (Para 0095) and the noise [an amount of friction in the medical device] (Claim 11) to a computing system [executable code stored on non-transitory, tangible, machine-readable media that when run by one or more processors] (Para 0093 and Figure 5, Element 500).
Examiner’s Note: Figure 5 is disclosed as usable with Figures 3A & 3B (Para 0093). Electrostatic friction
Diolaiti fails to teach the plurality of electrode connected to a plurality of electrode wires and the electrostatic friction. However, Carter teaches –
the noise being caused by an electrostatic friction [this may result in the addition of noise or interference to the current signal being transmitted] (Para 0037) [the compensation twisted pair 324 and can be used by the system to remove noise from the signal transmitted through the cable twisted pair 321] (Para 0053)
the plurality of electrodes connected to a plurality of electrode wires [a system can comprise a plurality of compensation loops and the subtractor can average the signal received from the plurality of compensation loops before deriving a compensated signal for each of the sensor signals] (Para 0054 and Figure 8; sensor = electrode in Carter) in order to assist in forming compensation that can be used to correct for noise (Abstract);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrosurgical electrodes of Diolaiti with the plurality of electrode wires as taught by Carter and to have the elements within the handle body as taught by Carter in order to assist in forming compensation that can be used to correct for noise (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the friction force measurements of noise of Diolaiti with the electrostatic friction measurement as taught by Carter in order to assist in forming compensation that can be used to correct for noise (Abstract).
Claim 2/1: Diolaiti teaches wherein the noise sensing element comprises at least one sensing wire [Shape sensor] (Figure 3A&B, Element 314) configured to pick up the noise [an amount of friction in the medical device] (Claim 11).
Claim 3/2/1: Diolaiti teaches wherein the at least one sensing wire [Shape sensor] (Figure 3A&B, Element 314) is positioned within the handle body [instrument carriage] (Figure 3A&B, Element 306) of the probe assembly [a medical instrument mounted on an insertion assembly] (Para 0052, Figure 3A&B, Element 300 and as shown in Figure 3A&B with Element 314).
Claim 4/2/1: Diolaiti fails to teach a probe cable assembly bundle. However, Carter teaches –
wherein the at least one sensing wire [sensor lead] (Figure 8, Element 305 and/or 304) being positioned within a probe cable assembly bundle (See Figure 9) that also includes the plurality of electrode wires [The cable 351 further comprises a plurality of elongate electrical conductors, as described in FIG. 8 above] (Para 0055)
the at least one sensing wire terminates before the distal tip (Figure 8, Element 303 also Figure 1, Element 28; the sensors are disclosed at the distal tip of the catheter), and
the at least one sensing wire and the plurality of electrode wires being connected to a common electrical circuit [compensated signal 335 can be transmitted to a medical positioning system or other system or device] (Para 0053 and See Figure 8) in order to assist in forming compensation that can be used to correct for noise (Abstract);
Both Diolaiti and Carter teach the obviousness of modifying the catheter configuration for the desired medical procedures (Para 0034 of Carter) (Para 0049 of Diolaiti). Thus changing the probe of Diolairi to include the probe cable assembly of Carter would have been obvious.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrosurgical electrodes of Diolaiti with the plurality of electrode wires as taught by Carter in order to assist in forming compensation that can be used to correct for noise (Abstract).
Claim 6/1: Diolaiti teaches further comprising a processor [executable code stored on non-transitory, tangible, machine-readable media that when run by one or more processors] (Para 0093 and Figure 5, Element 500) [One or more elements in embodiments of the invention… may be implemented in software to execute on a processor] (Para 0104) configured to determine a velocity of the actuator based on the position of the actuator [the position and/or velocity may be determined from the one or more signals from the one or more position sensors used to determine the acceleration] (Para 0072).
Claim 10/1: Diolaiti teaches the actuator movement sensing element comprising at least one of: an accelerometer [an acceleration provided by an accelerometer] (Para 0079).
Claim 11: Diolaiti teaches –
A method of detecting in a probe [a medical instrument mounted on an insertion assembly] (Para 0052 and Figure 3A&B), the method comprising:
flexing a distal tip [distal end] (Figure 3A&B, Element 318) of the probe [actuators controlling the motion of instrument carriage 306] (Para 0054) [distal end 218 to controllably bend distal end 218 as shown, for example, by broken dashed line depictions 219 of distal end 218] (Para 0048), via an actuator [actuators, such as servomotors] (Para 0052) positioned in a handle body [instrument carriage] (Figure 3A&B, Element 306) [Instrument carriage 306 may be a component of a teleoperational manipulator assembly (…102) that couples to point gathering instrument 304 to control…motion of a distal end 318 of an elongate device 310] (Para 0052) [teleoperational manipulator assembly 102 of FIG. 1 may be replaced by direct operator control…the direct operator control may include various handles and operator interfaces for hand-held operation of the instrument] (Para 0051)
Examiner’s Note: The instrument carriage is a component of the handle.
of the probe during a first time period,
the probe including a sensor (Figure 3A, Element 320 & 314) and the distal tip [distal end] (Figure 3A&B, Element 318) including a plurality of electrodes [electrosurgical electrodes] (Para 0046; Para 0052 discloses a medical instrument and Para 0046 discloses the medical instrument as electrosurgical electrodes);
detecting, via an actuator movement sensing element [position measuring device 320 provides information about the position of instrument body 312 as it moves on insertion stage 308 along an insertion axis A] (Para 0054), the sensor, a first position of the actuator in the handle body of the probe relative to the handle during the first time period (compare the position of Element 318 between Figures 3A&B);
detecting, via the actuator movement sensing element [position measuring device 320 provides information about the position of instrument body 312 as it moves on insertion stage 308 along an insertion axis A] (Para 0054), the sensor, a second position of the actuator in the handle body of the probe relative to the handle during the first time period (compare the position of Element 318 between Figures 3A&B),
the first position and the second position being different (compare the position of Element 318 between Figures 3A&B);
picking up noise via a noise sensing element of the sensor [the one or more force sensors may include a first force sensor located at an input of a low backlash drivetrain used to actuate the device and a second force sensor located at an output of the drivetrain] (Para 0097) [one or more proximal force sensors may be used to measure the amount of force resisting the desired motion in the device being monitored] (Para 0097) [friction force is determined using one or more models of friction for the device being monitored and the position and/or velocity of the device being monitored] (Para 0095) [an amount of friction in the medical device] (Claim 11); and
determining, via a processor [executable code stored on non-transitory, tangible, machine-readable media that when run by one or more processors] (Para 0093 and Figure 5, Element 500) [One or more elements in embodiments of the invention… may be implemented in software to execute on a processor] (Para 0104), a velocity of the actuator relative to the handle based on a combination of the first position of the actuator [position and/or velocity of the device being monitored] (Para 0095), the second position of the actuator [position and/or velocity of the device being monitored] (Para 0095) and the second position of the actuator and the noise [an amount of friction in the medical device] (Claim 11).
Diolaiti fails to teach the plurality of electrode connected to a plurality of electrode wires. However, Carter teaches –
the plurality of electrodes connected to a plurality of electrode wires [a system can comprise a plurality of compensation loops and the subtractor can average the signal received from the plurality of compensation loops before deriving a compensated signal for each of the sensor signals] (Para 0054 and Figure 8; sensor = electrode in Carter) in order to assist in forming compensation that can be used to correct for noise (Abstract);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrosurgical electrodes of Diolaiti with the plurality of electrode wires as taught by Carter and to have the elements within the handle body as taught by Carter in order to assist in forming compensation that can be used to correct for noise (Abstract)
Claim 12/11: Diolaiti teaches wherein the noise sensing element sensor comprises at least one sensing wire configured to detect the noise [Shape sensor] (Figure 3A&B, Element 314) generated by movement of the actuator [an amount of friction in the medical device] (Claim 11).
Claim 13/12/11: Diolaiti teaches wherein the at least one sensing wire is positioned within the handle body of the probe assembly [Shape sensor] (as shown in Figure 3A&B with Element 314) .
Claim 14/12/11: Diolaiti fails to teach the plurality of electrode wires. However, Carter teaches –
wherein the at least one sensing wire being [sensor lead] (Figure 8, Element 305 and/or 304) positioned within a probe cable assembly bundle (See Figure 9) that also includes the plurality of electrode wires [The cable 351 further comprises a plurality of elongate electrical conductors, as described in FIG. 8 above] (Para 0055)
the at least one sensing wire terminates before the distal tip (Figure 8, Element 303 also Figure 1, Element 28; the sensors are disclosed at the distal tip of the catheter), and
the at least one sensing wire and the plurality of electrode wires being connected to a common electrical circuit [compensated signal 335 can be transmitted to a medical positioning system or other system or device] (Para 0053 and See Figure 8) in order to assist in forming compensation that can be used to correct for noise (Abstract);
Both Diolaiti and Carter teach the obviousness of modifying the catheter configuration for the desired medical procedures (Para 0034 of Carter) (Para 0049 of Diolaiti). Thus changing the element to within or on the handle body would have been obvious and changing the probe of Diolairi to the plurality of electrode wires of Carter would have been obvious.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrosurgical electrodes of Diolaiti with the plurality of electrode wires as taught by Carter and to have the elements within the handle body as taught by Carter in order to assist in forming compensation that can be used to correct for noise (Abstract).
Claim 20/11: Diolaiti teaches the actuator movement sensing element comprising at least one of: an accelerometer [an acceleration provided by an accelerometer] (Para 0079).
Claim(s) 5 & 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diolaiti et al. (W/O2019/074786 A1; enclosed herein) and Carter et al. (W/O 2017/136599 A1; enclosed herein) and further in view of Aujla (U.S. Patent Application 2018/0056038 A1).
Claim 5/2/1: Diolaiti and Carter fail to teach sensing wire isolation. However, Carter in view of Aujila teaches –
the at least one sensing wire [puller wire] (Para 0045) being isolated [puller wires…are preferably coated with Teflon®] (Para 0045) [a biocompatible, electrically-nonconductive material, for example, TEFLON] (Para 0051) from the plurality of electrodes [electrode assembly] (Para 0040) as not electrically isolating the wires would result in noise and a possible short if electrical signals were not isolated from each other
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the Teflon of Aujila to the sensing wire of Carter in order to avoid the resulting noise and a possible short if electrical signals were not isolated from each other.
Claim 15/12/11: Diolaiti and Carter fail to teach sensing wire isolation. However, Carter in view of Aujila teaches –
the at least one sensing wire [puller wire] (Para 0045) being isolated [puller wires…are preferably coated with Teflon®] (Para 0045) [a biocompatible, electrically-nonconductive material, for example, TEFLON] (Para 0051) from the plurality of electrodes [electrode assembly] (Para 0040) as not electrically isolating the wires would result in noise and a possible short if electrical signals were not isolated from each other
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the Teflon of Aujila to the sensing wire of Carter in order to avoid the resulting noise and a possible short if electrical signals were not isolated from each other.
Claim(s) 7, 8, 16, 18 & 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diolaiti et al. (W/O2019/074786 A1; enclosed herein) and further in view of Carter et al. (W/O 2017/136599 A1; enclosed herein) and further in view of Bar-Tal et al. (U.S. Patent Application 2013/0296845 A1).
Claim 7/6/1: Doilaiti teaches –
the processor [One or more elements in embodiments of the invention… may be implemented in software to execute on a processor] (Para 0104)
actuator [actuators, such as servomotors] (Para 0052)
identify the velocity of the actuator [the position and/or velocity may be determined from the one or more signals from the one or more position sensors used to determine the acceleration] (Para 0072)
Doilaiti and Carter fail to teach a velocity threshold. However, Bar-Tal teaches –
the processor (Figure 1, Element 40) being further configured to identify intervals during which the velocity of the catheter is above a predetermined velocity threshold [If the velocity is above a specified threshold, such as 10 mm/sec, the catheter may be considered to be unstable] (Para 0047) [Each data point 100…indicates a catheter location measurement…The data are collected at predefined time intervals] (Para 0056) in order to detect loss of stability (Para 0047) in order to improve patient outcomes through understanding the stability of the catheter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the velocity determination of Doilaiti and Carter to include the velocity threshold as taught by Bar-Tal in order to improve patient outcomes through understanding the stability of the catheter.
Claim 8/1: Doilaiti and Carter fail to teach to blank out or filter signals.
However, Bar-Tal teaches –
further comprising a processor [Processor 40] (Para 0047) configured to blanking out signals or filtering signals [velocity filter] (Figure 4, Element 84) that are obtained during periods when a velocity of the catheter is above a predetermined velocity threshold [If the velocity is above a specified threshold, such as 10 mm/sec, the catheter may be considered to be unstable] (Para 0047) [Each data point 100…indicates a catheter location measurement…The data are collected at predefined time intervals] (Para 0056) in order to detect loss of stability (Para 0047) in order to improve patient outcomes through understanding the stability of the catheter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the velocity determination of Doilaiti and Carter to include the velocity threshold as taught by Bar-Tal in order to improve patient outcomes through understanding the stability of the catheter.
Claim 16/11: Doilaiti and Carter fail to teach to blank out or filter signals.
However, Bar-Tal teaches –
further comprising a processor [Processor 40] (Para 0047) configured to blanking out signals or filtering signals [velocity filter] (Figure 4, Element 84) that are obtained during periods when a velocity of the catheter is above a predetermined velocity threshold [If the velocity is above a specified threshold, such as 10 mm/sec, the catheter may be considered to be unstable] (Para 0047) [Each data point 100…indicates a catheter location measurement…The data are collected at predefined time intervals] (Para 0056) in order to detect loss of stability (Para 0047) in order to improve patient outcomes through understanding the stability of the catheter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the velocity determination of Doilaiti and Carter to include the velocity threshold as taught by Bar-Tal in order to improve patient outcomes through understanding the stability of the catheter.
Claim 18/11: Doilaiti teaches –
the processor [One or more elements in embodiments of the invention… may be implemented in software to execute on a processor] (Para 0104)
actuator [actuators, such as servomotors] (Para 0052)
identify the velocity of the actuator [the position and/or velocity may be determined from the one or more signals from the one or more position sensors used to determine the acceleration (using numerical differentiation to determine the velocity from the position), by integrating the acceleration (e.g., numerically via the rectangle rule, the trapezoid rule, and/or the like)] (Para 0072)
Doilaiti and Carter fail to teach a velocity threshold. However, Bar-Tal teaches –
further comprising identifying, via the processor (Figure 1, Element 40), intervals during which the velocity of the catheter is above a predetermined velocity threshold [If the velocity is above a specified threshold, such as 10 mm/sec, the catheter may be considered to be unstable] (Para 0047) [Each data point 100…indicates a catheter location measurement…The data are collected at predefined time intervals] (Para 0056) in order to detect loss of stability (Para 0047) in order to improve patient outcomes through understanding the stability of the catheter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the velocity determination of Doilaiti and Carter to include the velocity threshold as taught by Bar-Tal in order to improve patient outcomes through understanding the stability of the catheter.
Claim 21: Diolaiti teaches –
A handheld probe assembly [a medical instrument mounted on an insertion assembly] (Para 0052, Figure 3A&B, Element 300) comprising:
a handheld probe [elongate device] (Figure 3A, Element 310) including a distal tip [distal end] (Figure 3A&B, Element 318) with a plurality of electrodes [electrosurgical electrodes] (Para 0046; Para 0052 discloses a medical instrument and Para 0046 discloses the medical instrument as electrosurgical electrodes) and a plurality of electrode wires [Medical instrument 226 may additionally house cables, linkages, or other actuation controls (not shown) that extend between its proximal and distal ends to controllably the bend distal end of medical instrument 226] (Para 0047 and See Figure 2A), and
a handle body [instrument carriage] (Figure 3A&B, Element 306) [Instrument carriage 306 may be a component of a teleoperational manipulator assembly (…102) that couples to point gathering instrument 304 to control…motion of a distal end 318 of an elongate device 310] (Para 0052) comprising an actuator [actuators, such as servomotors] (Para 0052) configured to displace the distal tip during a first time period [distal end 218 to controllably bend distal end 218 as shown, for example, by broken dashed line depictions 219 of distal end 218] (Para 0048),
the actuator being configured to displace the distal tip [distal end 218 to controllably bend distal end 218 as shown, for example, by broken dashed line depictions 219 of distal end 218] (Para 0048) based on a direct physical contact to the actuator by a hand of a user [teleoperational manipulator assembly 102 of FIG. 1 may be replaced by direct operator control…the direct operator control may include various handles and operator interfaces for hand-held operation of the instrument] (Para 0051)
an actuator movement sensor [position measuring device 320 provides information about the position of instrument body 312 as it moves on insertion stage 308 along an insertion axis A] (Para 0054) within the handle body [Position measuring device 320 may include resolvers, encoders, potentiometers, and/or other sensors that determine the rotation and/or orientation of the actuators controlling the motion of instrument carriage 306 and consequently the motion of instrument body 312] (Para 0054) configured to detect a position of the actuator relative to the handle body during the first time period [actuators controlling the motion of instrument carriage 306 and consequently the motion of instrument body 312] (Para 0054);
at least one sensing wire configured to pick up noise [the one or more force sensors may include a first force sensor located at an input of a low backlash drivetrain used to actuate the device and a second force sensor located at an output of the drivetrain] (Para 0097) generated by a deflection of the electrode wires [friction force is determined using one or more models of friction for the device being monitored and the position and/or velocity of the device being monitored] (Para 0095) [an amount of friction in the medical device] (Claim 11); and
a computing system [executable code stored on non-transitory, tangible, machine-readable media that when run by one or more processors] (Para 0093 and Figure 5, Element 500) [One or more elements in embodiments of the invention… may be implemented in software to execute on a processor] (Para 0104) configured to:
(i) process signals from the actuator movement sensor [position and/or velocity of the device being monitored] (Para 0095),
(ii) identify noise from the at least one sensing wire [friction force is determined using one or more models of friction for the device being monitored and the position and/or velocity of the device being monitored] (Para 0095) [an amount of friction in the medical device] (Claim 11),
processing signals from the actuator movement sensor [position and/or velocity of the device being monitored] (Para 0095) and the noise from the at least one sensing wire [an amount of friction in the medical device] (Claim 11).
Diolaiti fails to teach the plurality of electrode connected to a plurality of electrode wires. However, Carter teaches –
the plurality of electrodes connected to a plurality of electrode wires [a system can comprise a plurality of compensation loops and the subtractor can average the signal received from the plurality of compensation loops before deriving a compensated signal for each of the sensor signals] (Para 0054 and Figure 8; sensor = electrode in Carter) in order to assist in forming compensation that can be used to correct for noise (Abstract);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrosurgical electrodes of Diolaiti with the plurality of electrode wires as taught by Carter and to have the elements within the handle body as taught by Carter in order to assist in forming compensation that can be used to correct for noise (Abstract)
Doilaiti and Carter fail to teach to blank out or filter signals. However, Bar-Tal teaches –
filtering signals [velocity filter] (Figure 4, Element 84) in order to detect loss of stability (Para 0047) in order to improve patient outcomes through understanding the stability of the catheter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the velocity determination of Doilaiti and Carter to include the velocity threshold as taught by Bar-Tal in order to improve patient outcomes through understanding the stability of the catheter.
Claim(s) 9 & 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diolaiti et al. (W/O2019/074786 A1; enclosed herein) and further in view of Carter et al. (W/O 2017/136599 A1; enclosed herein) and further in view of Demer (EP 0275638 A2; enclosed prior).
Claim 9/1: Doilaiti teaches the sensor including a first sensor component attached to the actuator and a second sensor component attached to the handle body of the probe [the one or more force sensors may include a first force sensor located at an input of a low backlash drivetrain used to actuate the device and a second force sensor located at an output of the drivetrain] (Para 0097).
Doilaiti and Carter fail to teach a first and second sensor components attached to the actuator in mobile and stationary manners. However, Demer teaches –
the actuator sensing element including a first sensor component (Figure 4, Element 9) attached to the actuator (Figure 4, Element 11) and a second sensor component (Figure 4, Element 6) attached to the handle body (Figure 4, Element 13) of the probe, such that the first sensor component is mobile relative to the handle body of the probe [axial movement of the core 9 in the LVDT 6] (Col. 7, Line 10-11) and the second sensor component is stationary relative to the handle body of the probe (Figure 4) in order to generates a signal proportional to the core's axial position within the device (Col. 6, Line 31-36) for monitoring the performance of the device during the procedure (Col. 4, Line 36-37)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the actuator of Doilaiti and Carter to include the position sensing as taught by Demer in order to generates a signal proportional to the core's axial position within the LVDT (Col. 6, Line 31-36).
Claim 19/11: Doilaiti teaches the sensor including a first sensor component attached to the actuator and a second sensor component attached to the handle body of the probe [the one or more force sensors may include a first force sensor located at an input of a low backlash drivetrain used to actuate the device and a second force sensor located at an output of the drivetrain] (Para 0097).
Doilaiti and Carter fail to teach a first and second sensor components attached to the actuator in mobile and stationary manners. However, Demer teaches –
the sensor including a first sensor component (Figure 4, Element 9) attached to the actuator (Figure 4, Element 11) and a second sensor component (Figure 4, Element 6) attached to the handle body (Figure 4, Element 13) of the probe, such that the first sensor component is mobile relative to the handle body of the probe [axial movement of the core 9 in the LVDT 6] (Col. 7, Line 10-11) and the second sensor component is stationary relative to the handle body of the probe (Figure 4) in order to generates a signal proportional to the core's axial position within the device (Col. 6, Line 31-36) for monitoring the performance of the device during the procedure (Col. 4, Line 36-37)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the actuator of Doilaiti and Carter to include the position sensing as taught by Demer in order to generates a signal proportional to the core's axial position within the LVDT (Col. 6, Line 31-36).
Response to Arguments
Applicant’s arguments, see Page 7, filed 05/28/2026, with respect to the Rejections under 35 USC § 112(a) & (b) have been fully considered and are persuasive. The Rejections under 35 USC § 112(a) & (b) of the Claims have been withdrawn.
Applicant’s arguments with respect to claim(s) 1-16 & 18-21 have been considered but are moot because the rejection above has been amended in light of the amendments to the claims in order to overcome the 35 USC § 112 rejections. In the rejection above, the Examiner points to different embodiments and a different combination of Diolaiti and Carter. Friction is a noise source and Diolaiti teaches measuring friction. Diolaiti measures the friction force physically. The Examiner argues that an electrostatic friction measurement would have been understood as the friction measurement of Diolaiti. The Specification of the Applicant discloses that tension on the wire and displacement of the wire (in other words friction on the wire) is a source of noise (Para 0032 of the Specification as originally filed). The rejection of Claim 21 was amended to include Bar-Tal who is relied on for teaching filtering of the signals. The Examiner notes that the arguments presented were with respect to Diolaiti only and fail to specifically present arguments regarding the combinations of Diolaiti, Carter and Bar-Tal. The rejection is final, deemed proper and is hereby maintained.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HELENE C BOR whose telephone number is (571)272-2947. The examiner can normally be reached Mon - Fri 10:30 - 6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Helene Bor/Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
Prosecution Insights