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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/28/2026 has been entered.
Status of Claims
Claims 1 and 19 are currently amended.
Response to Arguments
Applicant’s arguments, see pages 9-14, filed 4/28/2026, with respect to the rejection(s) of
claim(s) 1-3, 5, 7-8, 15-17, 19-20, 22-23 and 27 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Turovskiy.
35 U.S.C. 103:
Regarding claim 1 and 19, applicant argues that Daly, alone or in combination with the prior
art, does not teach “determining a prioritized order of a plurality of operating parameters associated with the endoscopic surgical system, wherein the prioritized order specifies a conditional sequence in which a first operating parameter is adjusted before a second operating parameter is adjusted.” After further search and consideration, the examiner will now rely on Turovskiy to teach this amended limitation (col. 7, lines 10-36; col. 8, lines 8-38; col. 19, lines 11-20). The thermal energy generator 26 can be configured to deliver the treatment energy via an automated control algorithm 30. The processing circuitry may be configured to execute one or more evaluation/feedback algorithms 31. The feedback algorithm may be based on maintaining the tissue and/or the direct heating element at a desired temperature luring delivery of heat. The main controller of the thermal energy generator 26 can adjust the settings (e.g., the control algorithm 30) of the thermal energy generator 26 to the desired operating parameters/characteristics (e.g., power levels, display modes, etc.) associated with the specific catheter. The device is fully capable of determining a “conditional sequence in which a first operating parameter is adjusted before a second operating parameter” by using the control algorithm to maintain a specified temperature at the surgical site.
Therefore, 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 control system of Hoang with the control algorithm from Turovskiy for the benefit of creating a prioritized order of operation of the catheter to maintain/optimize a certain temperature of the patient’s tissue during surgical procedure.
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.
Claims 1-3, 5, 7-8, 15-17, 19-20, 22-23, and 27 are rejected under 35 U.S.C. 103 as being
unpatentable by Hoang et al. US Pat.: US 10888376 B2, hereinafter Hoang in view of Turovskiy et al. US Pat.: US 10709490 B2, hereinafter Turovskiy.
Regarding claim 1, Hoang teaches an endoscopic surgical system, comprising:
an endoscopic surgical device controllably coupled to a medical instrument for delivering energy to an anatomical target at a surgical site during a procedure (fig. 1-2; col. 4-5, lines 50-67 and 1-24);
a temperature sensor for measuring temperatures in a vicinity of the surgical site at different times during the procedure (fig. 1-2; col. 13, lines 8-15); The infrared sensor 912 can monitor the temperature of the tissue.
and a controller circuit configured to: generate a temperature trend or a prediction of future temperature at the surgical site based at least in part on the temperature measurements at the different times (fig. 1-2; col. 2, lines 46-67; col. 6, lines 32-42); The surgical laser controller can be configured to measure temperature of the target tissue based on a signal from the infrared sensing assembly.
and based at least in part on the generated temperature trend or the prediction of future temperature at the surgical site, adjust at least one operating parameter associated with the endoscopic surgical system to achieve or maintain substantially a desired temperature at the surgical site during the procedure (col. 19, lines 9-20). The surgical laser system can incorporate temperature and tissue sensors to optimize laser delivery settings for target the desired tissues and reduce surgical procedure times. Thermal tracking is disclosed and equates to temperature trend.
However, Hoang does not teach determining a prioritized order of a plurality of operating parameters associated with the endoscopic surgical system, wherein the prioritized order specifies a conditional sequence in which a first operating parameter is adjusted before a second operating parameter is adjusted, and in accordance with the prioritized order, adjusting at least one of the operating parameters to achieve or maintain substantially a desired temperature at the surgical site during the procedure.
Turovskiy, in the same field of endeavor, teaches to determining a prioritized order of a plurality of operating parameters associated with the endoscopic surgical system, wherein the prioritized order specifies a conditional sequence in which a first operating parameter is adjusted before a second operating parameter is adjusted, and in accordance with the prioritized order, adjusting at least one of the operating parameters to achieve or maintain substantially a desired temperature at the surgical site during the procedure (col. 7, lines 10-36; col. 8, lines 8-38; col. 19, lines 11-20). The thermal energy generator 26 can be configured to deliver the treatment energy via an automated control algorithm 30. The processing circuitry may be configured to execute one or more evaluation/feedback algorithms 31. The feedback algorithm may be based on maintaining the tissue and/or the direct heating element at a desired temperature luring delivery of heat. The main controller of the thermal energy generator 26 can adjust the settings (e.g., the control algorithm 30) of the thermal energy generator 26 to the desired operating parameters/characteristics (e.g., power levels, display modes, etc.) associated with the specific catheter. The device is fully capable of determining a “conditional sequence in which a first operating parameter is adjusted before a second operating parameter” by using the control algorithm to maintain a specified temperature at the surgical site.
Therefore, 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 control system of Hoang with the control algorithm from Turovskiy for the benefit of creating a prioritized order of operation of the catheter to maintain/optimize a certain temperature of the patient’s tissue during surgical procedure.
Regarding claim 2, Hoang in view of Turovskiy teaches the claimed invention and Hoang further
teaches wherein the medical instrument comprises at least one laser system for delivering laser energy to a calculi target at the surgical site when the endoscopic surgical system operates in accordance with the adjusted at least one operating parameter (col. 19, lines 9-20). The surgical laser system can incorporate temperature and tissue sensors to optimize laser delivery settings for target the desired tissues and reduce surgical procedure times. This adjustment if for the delivery of laser energy to a calculi target.
Regarding claim 3 and 20, Hoang in view of Turovskiy teaches the claimed invention and Hoang
further teaches wherein the controller circuit is further configured to: determine a temperature change rate at the surgical site using the generated temperature trend; and adjust the at least one operating parameter in response to the determined temperature change rate exceeding a predetermined threshold (col. 2, lines 46-58; col. 19, lines 9-20). The surgical laser controller can be configured to control the surgical laser to prevent thermal damage of the target tissue based on a signal from the infrared sensing assembly, such as reducing a power of the surgical laser when the infrared sensing assembly indicates that the temperature of the tissue reaches a warning level, or the rate of change of the temperature can show that the tissue can fast approach a damage threshold.
Regarding claim 5 and 22, Hoang in view of Turovskiy teaches the claimed invention and Hoang
further teaches wherein the controller circuit is further configured to: estimate a safe-operation time window using the temperature measurements at the different times, the safe-operation time window representing an estimate of time taken to reach a safe-operating temperature limit at the surgical site; and adjust the at least one operating parameter in response to the estimated safe-operation time window falling below a time threshold (col. 14, lines 51-67; col. 16-17, lines 51-67, and 1-4). The surgical laser system can also keep track of the laser time. A tissue temperature at a little below the critical temperature together with a zero rate of change can be an optimized tissue condition, e.g., a fastest surgical process without tissue damages.
Regarding claim 7 and 23, Hoang in view of Turovskiy teaches the claimed invention and Hoang
further teaches wherein to adjust the laser output setting, the controller circuit is further configured to reduce an average power of laser pulses delivered to the surgical site in response to (I) the generated temperature trend indicating an increase in temperature at a rate exceeding a rate threshold, or (ii) the prediction of future temperature exceeding a temperature threshold (col. 2, lines 46-58; col. 19, lines 9-20). The surgical laser controller can be configured to control the surgical laser to prevent thermal damage of the target tissue based on a signal from the infrared sensing assembly, such as reducing a power of the surgical laser when the infrared sensing assembly indicates that the temperature of the tissue reaches a warning level, or the rate of change of the temperature can show that the tissue can fast approach a damage threshold.
Regarding claim 8, Hoang in view of Turovskiy teaches the claimed invention and Hoang further
teaches wherein to reduce the average power of laser pulses includes to reduce at least one of: a pulse width of a laser pulse; a peak power of a laser pulse; and a pulse frequency representing a number of laser pulses per unit time (col. 2, lines 46-58; col. 19, lines 9-20). The surgical laser controller can be configured to control the surgical laser to prevent thermal damage of the target tissue based on a signal from the infrared sensing assembly, such as reducing a power of the surgical laser when the infrared sensing assembly indicates that the temperature of the tissue reaches a warning level, or the rate of change of the temperature can show that the tissue can fast approach a damage threshold. Therefore, pulse width is reduced.
Regarding claim 15 and 27, Hoang in view of Turovskiy teaches the claimed invention and Hoang
further teaches wherein the endoscopic surgical device includes an optical pathway with an adjustable distal portion, the optical pathway configured to direct the laser energy to the anatomical target, wherein the controller circuit is further configured to, based at least in part on the generated temperature trend or the prediction of future temperature at the surgical site, generate a control signal to an actuator coupled to the optical pathway to adjust a position or orientation of the distal portion of the optical pathway relative to the anatomical target (col. 12, lines 31-37). The aiming lasers can closely track the position and orientation of the surgical instrument. Three-dimensional tracking systems employing multiple imaging systems or signaling elements can be readily adapted to the surgical laser system.
Regarding claim 16, Hoang in view of Turovskiy teaches the claimed invention and Hoang further
teaches wherein the at least one operating parameter associated with the endoscopic surgical system comprises at least one of: a temperature of an irrigant before being applied to the surgical site; an irrigation flow rate; a suction flow rate; or a laser output setting of a laser system (col. 2, lines 11-27). Control at least one of a power, a pulse rate, and a pulse width of the surgical laser output.
Regarding claim 17, Hoang in view of Turovskiy teaches the claimed invention and Hoang further
teaches wherein the controller circuit is further configured to perform the adjustment with a bias toward one of the operating parameters based at least in part on at least one of the generated temperature trend, the prediction of future temperature, or a pressure at the surgical site (col. 19, lines 9-20). The surgical laser system can incorporate temperature and tissue sensors to optimize laser delivery settings for target the desired tissues and reduce surgical procedure times. Thermal tracking is disclosed and equates to temperature trend.
Regarding claim 19, Hoang teaches a method for controlling temperature at a surgical site of a
patient during an endoscopic procedure using an endoscopic surgical system, the method comprising:
directing energy produced by a medical instrument to an anatomical target at the surgical site (fig. 1-2; col. 4-5, lines 50-67 and 1-24);
measuring temperatures in a vicinity of the surgical site at different times during the procedure (fig. 1-2; col. 13, lines 8-15); The infrared sensor 912 can monitor the temperature of the tissue.
generating a temperature trend or a prediction of future temperature at the surgical site based at least in part on temperature measurements at the different times (fig. 1-2; col. 2, lines 46-67; col. 6, lines 32-42); The surgical laser controller can be configured to measure temperature of the target tissue based on a signal from the infrared sensing assembly.
and based at least in part on the generated temperature trend or the prediction of future temperature at the surgical site, adjusting at least one operating parameter associated with the endoscopic surgical system to achieve or maintain substantially a desired temperature at the surgical site during the procedure (col. 19, lines 9-20). The surgical laser system can incorporate temperature and tissue sensors to optimize laser delivery settings for target the desired tissues and reduce surgical procedure times. Thermal tracking is disclosed and equates to temperature trend.
However, Hoang does not teach determining a prioritized order of a plurality of operating parameters associated with the endoscopic surgical system, wherein the prioritized order specifies a conditional sequence in which a first operating parameter is adjusted before a second operating parameter is adjusted, and in accordance with the prioritized order, adjusting at least one of the operating parameters to achieve or maintain substantially a desired temperature at the surgical site during the procedure.
Turovskiy, in the same field of endeavor, teaches to determining a prioritized order of a plurality of operating parameters associated with the endoscopic surgical system, wherein the prioritized order specifies a conditional sequence in which a first operating parameter is adjusted before a second operating parameter is adjusted, and in accordance with the prioritized order, adjusting at least one of the operating parameters to achieve or maintain substantially a desired temperature at the surgical site during the procedure (col. 7, lines 10-36; col. 8, lines 8-38; col. 19, lines 11-20). The thermal energy generator 26 can be configured to deliver the treatment energy via an automated control algorithm 30. The processing circuitry may be configured to execute one or more evaluation/feedback algorithms 31. The feedback algorithm may be based on maintaining the tissue and/or the direct heating element at a desired temperature luring delivery of heat. The main controller of the thermal energy generator 26 can adjust the settings (e.g., the control algorithm 30) of the thermal energy generator 26 to the desired operating parameters/characteristics (e.g., power levels, display modes, etc.) associated with the specific catheter. The device is fully capable of determining a “conditional sequence in which a first operating parameter is adjusted before a second operating parameter” by using the control algorithm to maintain a specified temperature at the surgical site.
Therefore, 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 control system of Hoang with the control algorithm from Turovskiy for the benefit of creating a prioritized order of operation of the catheter to maintain/optimize a certain temperature of the patient’s tissue during surgical procedure.
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.
Claims 4 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Hoang in view of
Turovskiy in view of Sanker et al. US Pub.: US 20230121554 A1, hereinafter Sanker.
Regarding claim 4 and 21, Hoang in view of Turovskiy teaches the claimed invention and Hoang
further teaches wherein the controller circuit is further configured to: generate the prediction of future temperature at the surgical site; and adjust the at least one operating parameter in response to the prediction of future temperature exceeding a temperature threshold (col. 19, lines 9-20). The surgical laser system can incorporate temperature and tissue sensors to optimize laser delivery settings for target the desired tissues and reduce surgical procedure times. Thermal tracking is disclosed and equates to temperature trend.
However, Hoang in view of Turovskiy does not explicitly teach to generate a trained prediction
model using the temperature measurements at the different times.
Sanker, in the same field of endeavor, teaches to generate a trained prediction model using the
temperature measurements at the different times (paragraph 66). After the temperature, force, and microphone data are transmitted to the processing computer, algorithms (can be machine-learning-based) can be run to modulate the duty cycle and energy level to control grasper temperature and keep it at the optimal level while showing valuable information to the surgeon on a display.
Therefore, 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 processor of Hoang in view of Turovskiy with the machine learning prediction model of Sanker for the benefit of accurately modulating the duty cycle and energy level to control grasper temperature and keep it at the optimal level while showing valuable information to the surgeon.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hoang in view of Turovskiy
in view of Johnson et al. US Pub.: US 20160095505 A1, hereinafter Johnson.
Regarding claim 6, Hoang in view of Turovskiy does not explicitly teach wherein the at least one
operating parameter to be adjusted includes a laser output setting of the at least one laser system, wherein the controller circuit is further configured to toggle between at least first and second pre-determined pulse profiles based at least in part on the generated temperature trend or the prediction of future temperature at the surgical site, the second pre-determined pulse profile having a lower average power than the first pre- determined pulse profile.
Johnson, in the same field of endeavor, teaches wherein the at least one operating parameter to
be adjusted includes a laser output setting of the at least one laser system, wherein the controller circuit is further configured to toggle between at least first and second pre-determined pulse profiles based at least in part on the generated temperature trend or the prediction of future temperature at the surgical site, the second pre-determined pulse profile having a lower average power than the first pre- determined pulse profile (paragraph 87-89). Pulse duration may be switched to achieve a desired mode of operation. A selection of pulse profiles is disclosed.
Therefore, 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 processor of Hoang in view of Turovskiy with the switching mechanism from Johnson for the benefit of achieving a desired pulse duration ranging from femtoseconds, to picoseconds to longer times.
Claims 9-10, 18, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Hoang in
view of Turovskiy in view of Leung et al. US Pub.: US 20140128861 A1, hereinafter Leung.
Regarding claim 9 and 24, Hoang in view of Turovskiy does not teach comprising an irrigation
and/or suction system configured to provide irrigant into, and suction of fluid from, the surgical site, wherein to adjust the at least one operating parameter, the controller circuit is further configured to adjust, via the irrigation and/or suction system, at least one of an irrigation flow or a suction flow based at least in part on the generated temperature trend or the prediction of future temperature at the surgical site.
Leung, in the same field of endeavor, teaches comprising an irrigation and/or suction system
configured to provide irrigant into, and suction of fluid from, the surgical site, wherein to adjust the at least one operating parameter, the controller circuit is further configured to adjust, via the irrigation and/or suction system, at least one of an irrigation flow or a suction flow based at least in part on the generated temperature trend or the prediction of future temperature at the surgical site (fig. 1; paragraph 55 and 59-61). Cooling devices 108 is attached to the ablation system and configured to apply fluid. Flow rate is also modulated based on temperature.
Therefore, 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 system of Hoang in view of Turovskiy to attach a cooling device from Leung for the benefit of immediately cooling the target tissue or distal portion of the ablation device when necessary.
Regarding claim 10, Hoang in view of Turovskiy in view of Leung teaches the claimed invention
and Leung further teaches wherein the controller circuit is configured to increase at least one of the irrigation flow or the suction flow in response to (i) the generated temperature trend indicating an increase in temperature at a rate exceeding a rate threshold, or (ii) the prediction of future temperature exceeding a temperature threshold (fig. 1; paragraph 55 and 59-61). Cooling devices 108 is attached to the ablation system and configured to apply fluid. Flow rate is also modulated based on temperature.
Regarding claim 18, Hoang in view of Turovskiy in view of Leung teaches the claimed invention
and Leung further teaches wherein the controller circuit is further configured to: upon determining that the pressure at the surgical site is substantially below a maximal allowable pressure, adjust at least one of the irrigation flow rate or the suction flow rate prior to adjusting the laser output setting; and upon determining that the pressure at the surgical site is substantially close to a maximal allowable pressure, adjust the laser output setting prior to adjusting the irrigation flow rate or the suction flow rate.
Claims 11 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Hoang in view
of Turovskiy in view of Leung in view of Sanker.
Regarding claim 11 and 25, Hoang in view of Turovskiy in view of Leung teaches the claimed
invention and Leung further teaches wherein the controller circuit is further configured to selectively increase the irrigation flow or the suction flow via the irrigation and/or suction system, including to: increase the suction flow or decrease the irrigation flow when the sensed pressure exceeds an upper pressure limit; increase one or both of the irrigation flow or the suction flow when the sensed pressure is within a range defined by the upper pressure limit and a lower pressure limit; and increase the irrigation flow or decrease the suction flow when the sensed pressure falls below the lower pressure limit.
However, Hoang in view of Turovskiy in view of Leung does not explicitly teach further comprising a pressure sensor configured to sense a pressure at the surgical site during the procedure.
Sanker, in the same field of endeavor, teaches further comprising a pressure sensor configured to sense a pressure at the surgical site during the procedure (paragraph 41). Pressure sensor 214.
Therefore, 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 system of Hoang in view of Turovskiy in view of Leung to attach the pressure sensor from Sanker for the benefit of monitoring the pressure of the irrigation flow and to achieve a desired flow rate.
Allowable Subject Matter
Claims 12-14 and 26 are objected to as being dependent upon a rejected base claim, but would
be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The
closest art: US 20140128861 A1, teaches measuring the change in temperature of the inflow and outflow cooling fluid (fig. 9; paragraph 100-101). However, no prior art teaches every limitation of claim 12, specifically, “an irrigant treatment unit configured to alter a temperature of the irrigant, wherein the controller circuit is further configured to generate a control signal to the irrigant treatment unit to adjust a temperature of the irrigant before reaching the surgical site based at least in part on the generated temperature trend or the prediction of future temperature at the surgical site.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.J.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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