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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/10/2025 has been entered.
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.
Claim(s) 1-10 & 21 is/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 Claim 1 & 21
Claim 1 states, “the sensor…configured to detect a changeable position of the actuator relative to the handle body”. A sensor configured to perform this detection would have to be an accelerometer as disclosed in Para 0047. The sensor is also further limited to “directly detect noise generated by an engagement of the actuator” and that the noise is “caused by an electrostatic friction”. Vibration cause by the actuator results in noise and thus measuring noise from measuring the accelerometer being above a threshold makes sense. The current claim though is contradictory and does not make sense as to how the accelerometer is detecting noise caused by electrostatic friction. 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
However the assumption, of the sensor comprising two parts, falls apart in light of the claim limitation of “the detected changeable position and the noise being combined in a single signal to the sensor”. It is not understood how sensor detected both a position and an electrostatic friction are detected by the sensor. The Specification as originally filed contains no schematic or drawings of how the sensor performs this. In fact 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. The Specification does not support how a sensor performs both. If a sensor as a capacitive displacement sensor, Hall-effect sensor or resistor displacement sensor can detect electrostatic noise, the Specification needs to disclose how this mechanism is working.
Thus, the sensor of Claim 1 cannot be configured to detect noise and changeable position. The claim limitation is confusing as it leads one to believe that the sensor is measuring two different values directly from the wire. A similar analysis applies to Claim 21.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-16 & 18-21 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As discussed in the 35 USC § 112(b) rejection above, the Specification and Drawings as originally filed does not support the following:
the sensor being further configured to directly detect noise generated by an engagement of the actuator
the detected changeable position and noise being combined into a single signal to the sensor
the noise being cause by an electrostatic friction
a sensor…configured to detect a position of the actuator relative to the handle body
the sensor comprising at least one sensing wire configured to detect noise generated by a deflection of the electrode wires
the sensor being further configured to output a signal indicating the position of the actuator and the noise generated as a combined value
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) 11-14 & 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 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), via an actuator [actuators, such as servomotors] (Para 0052) positioned on a handle body [instrument body] (Figure 3A&B, Element 312) [scroll wheel] (Para 0058) [direct operator control may include various handles and operator interfaces for hand-held operation of the instrument] (Para 0051) of the probe during a first time period,
the probe including a 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) and the distal tip including a plurality of electrodes [electrosurgical electrodes] (Para 0046);
detecting via 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 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); and
determining, via a processor [sensor system] (Figure 1, Element 108) [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 the first position and the second position of the actuator, the velocity determination including the noise [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) such that the noise in included as part of the velocity determination (Para 0072).
Diolaiti fails to teach the plurality of electrode wires, the sensor being within the handle body and the electrode wire noise. However, Carter teaches –
electrode wire noise [this may result in the addition of noise or interference to the current signal being transmitted] (Para 0037)
positioned in a handle body [connector 30 is disposed within the handle 20 of the catheter 12] (Para 0034)
detecting via the sensor the noise [A subtractor can derive a signal from each of the sensors with a compensation signal from a compensation loop] (Para 0054) [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)
a 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);
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 12/11: Diolaiti teaches wherein the sensor comprises at least one sensing wire configured to detect the noise [Shape sensor] (Figure 3A&B, Element 314).
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 sensor comprising at least one of: an accelerometer [an acceleration provided by an accelerometer] (Para 0079).
Claim(s) 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 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) 16 & 18 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 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 [sensor system] (Figure 1, Element 108) [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 –
the processor (Figure 1, Element 40) is further being 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(s) 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 19/11: Doilaiti and Carter fail to teach a first and second sensor components attached to the actuator. 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 6, filed 10/10/2025, with respect to the Claim Objections have been fully considered and are persuasive. The Objections of the Claims have been withdrawn.
Applicant’s arguments, see Page 7, filed 10/10/2025, with respect to the Rejections under 35 USC § 112(b) have been fully considered and are persuasive. The Rejections under 35 USC § 112(b) of the Claims have been withdrawn. However in light of the new claim amendments, new 35 USC § 112 rejections are pending above.
Applicant’s arguments with respect to claim(s) 1-16 & 18-21 have been considered but are moot because the new ground of rejection does not rely on the manner in which the reference(s) was/were applied in the prior rejection of record. No pertinent arguments remain.
Conclusion
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