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 .
Election
The election of claims 1-15 is considered without traverse and made final. See MPEP 818.01 (portions below) -
818.01(a) Reply Must be Complete [R-07.2015]
As indicated in the first sentence of 37 CFR 1.143, the traverse to a requirement for restriction must be complete as required by 37 CFR 1.111(b). Under this rule, the applicant is required to specifically point out the reason(s) on which he or she bases his or her conclusion(s) that a requirement to restrict is in error. A mere broad allegation that the requirement is in error does not comply with the requirement of 37 CFR 1.111. Thus the required provisional election (see MPEP § 818.01(b)) becomes an election without traverse if accompanied by an incomplete traversal of the requirement for restriction.
Response to Amendment
The amendment filed on 2/27/2026 has been entered. Claims 1-15 are pending. Claims 16-26 are withdrawn from further consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/27/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 1, 4-5, is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao (US 20150335385 A1) in view of Shelton (US 20180055568).
Regarding claim 1, Miao discloses endoscopic surgical system (FIG. 1), comprising:
an endoscopic surgical device (Imager 110 and heating laser 120), controllably coupled to a medical instrument (active tracking system 100) for delivering energy to a surgical site in accordance with at least one operating parameter to achieve a specific treatment effect of a second target (maintaining the temperature of the high-temperature region 154 substantially equal to a specified temperature; Para [0047]; Temperature can be the operating parameter) at the surgical site during a procedure;
an imaging sensor (Imager 110) configured to generate images or video frames of at least a portion of the surgical site during the procedure; and
a controller circuit (Active system 500) configured to:
analyze (Infrared imaging determines the temperature of the region 154; FIG. 1; para [0005]) the generated images or video frames to determine whether a degree of heat built up in a target at the surgical site, exceeds a predetermined threshold (Image processing module 515; FIG. 5; The heating laser 120 could be operated such that the location of the target region 152 (i.e., the location at which the beam of electromagnetic radiation 125 intersect with the biological tissue 150) is maintained proximate to a temperature region 154. The heating laser 120 could be further operated to maintain the temperature of the high-temperature region 154 at a temperature greater than the temperature of regions of the biological tissue 150 that neighbor the high-temperature region. Maintaining the temperature of the high-temperature region 154 substantially equal to a specified temperature; Para [0047]; Infrared imaging determines the temperature of the second target, the region 154; FIG. 1; para [0005]); and
determine whether to adjust the at least one operating parameter associated with the endoscopic surgical system so as to substantially maintain the specific treatment effect of a second target at the surgical site (Maintaining the temperature of the high-temperature region 154 substantially equal to a specified temperature; Para [0047]; Infrared imaging determines the temperature of the region 154; FIG. 1; para [0005]).
Miao does not expressly disclose avoiding damaging a first target due to heat buildup during the procedure.
Shelton is directed to systems and methods for controlling an irrigation flow rate during a lithotripsy procedure (abstract) and teaches avoiding damaging a first target due to heat buildup during the lithotripsy procedure (If the processor indicates that the temperature of the surgical place around the stone 41 in the patient's body is high, it can increase the irrigation flow rate to bring the temperature in the acceptable range to prevent or reduce the tissue damage; FIG. 4; Para [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Miao to provide an irrigation system for controlling temperature (in the surrounding area of irradiation of Miao) in accordance with the teaching of Shelton so that overheating of the surrounding area could be prevented (Para [0032] of Shelton).
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Regarding claim 4, Miao teaches wherein: the endoscopic surgical device is configured to direct an aiming beam from a light source to the surgical site (Heating laser 220, 320; FIGS. 2A-2B), the aiming beam having a characteristic color component (infrared component; para [0065]); and
the controller circuit is further configured to identify a footprint of the aiming beam in the generated images or video frames (An imager 210; an image of a high temperature region 274a; Para [0049]), and determine the degree of heat built up in the first target based on an increase in intensity of the characteristic color component at a vicinity of the footprint of the aiming beam (Target region 272a is determined by the imager based on the location of high temperature region. Para [0056]; Temperature of the regions of the environment is detected. The amplitude of the infrared is used to determine the high temperature region. Para [0029], [0051]).
Regarding claim 5, Miao teaches wherein the controller circuit is further configured to: determine a rate of heat built up in the first target based on a comparison of the images or video frames taken at different times during the procedure (Gaussian distribution is used in locating high temperature region; para [0051]; The amplitude of the infrared is used to determine the high temperature region. Para [0029], [0051]); and
adjust the at least one operating parameter associated with the endoscopic surgical system in accordance with the determined degree (Controlling the heating laser 120 based on information (e.g., images of the biological tissue 150) generated by the imager 110; para [0046]) or rate of tissue whitening.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao (US 20150335385) in view of Shelton (US 20180055568) and further in view of Ingle (US 20100049186) and Tanigami (US 20210386270).
Regarding claim 2, Miao does not expressly disclose wherein the first target comprises tissue in a urinary system, the second target comprises a calculi target, and the medical instrument comprises at least one laser system for delivering laser energy to treat the calculi target at the surgical site.
Ingle is directed to methods for modifying collagenous tissues (abstract) and teaches wherein the first target comprises tissue in a urinary system (Treating urinary incontinence in a noninvasive manner; Raising the temperature of the target collagenous tissue to a value in the range from about 60.degree. C. to 100.degree. C); Para [0022], [0079]).
Tanigami is directed to light sources configured to generate excitation light for medical system (abstract) and teaches that the second target comprises a calculi target (calculus breakdown by a laser; para [0135]), and the medical instrument comprises at least one laser system for delivering laser energy to treat the calculi target at the surgical site (light emission unit 31; FIG. 2; Para [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Miao to include the urinary system as the target site as taught by Ingle so that urinary system could be treated. Further, it would have been obvious to further modify Miao to include and use laser system in accordance with the teaching of Tanigami for breaking up the calculi.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao (US 20150335385) in view of Shelton (US 20180055568) and further in view of Ingle (US 20100049186), Tanigami (US 20210386270) and Watanabe (US 20220302667).
Regarding claim 6, Miao does not expressly disclose wherein the controller circuit is further configured to: wherein the at least one operating parameter to be adjusted includes a laser output setting of the at least one laser system, the controller circuit is further configured to adjust the laser output setting so as to produce a non-equilibrium irrigation flow or to promote collapses of vaporized bubbles induced by the laser energy.
Watanabe is directed to an active tracking system that includes an imager configured to image the temperature of a biological tissue (abstract) and teaches wherein the controller circuit is further configured to: wherein the at least one operating parameter to be adjusted includes a laser output setting (A waveform control unit (a pulse generation unit, a repetition frequency adjustment unit, a laser output change unit) 27. FIG. 1; Para [0050]) of the at least one laser system, the controller circuit is further configured to adjust the laser output setting so as to produce a non-equilibrium irrigation flow or to promote collapses of vaporized bubbles induced by the laser energy (The Laser output is adjusted until immediately before the vaporized bubble disappear; FIG. 2; para [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Miao to use a laser system to control non-equilibrium irrigation flow in accordance with the teaching of Watanabe so that the irrigation could be used in surgery for cleaning of the surgical site.
Regarding claim 7, Miao as modified, teaches wherein the laser output setting to be adjusted comprises a pulse sequencing (Watanabe: Laser beam emitted from the laser beam source 21 is adjusted to a pulse train of a frequency at which the laser beam is irradiated during a period overlapping with the generation period in which the bubble B is generated in the solution W until immediately before the bubble B disappears after being generated in the solution W by the laser beam; Para [0073]) representing a temporal distribution of laser pulses within a specific time interval (Watanabe: Change an output of the pulsed laser beam; continuously emit the laser beam until a bubble generated from a laser emission end by an irradiation of the laser beam reaches a crushing target; FIG. 12; para [0012], [0107]), the laser pulses being delivered to the second target in accordance with the adjusted pulse sequencing (square pulse train; FIG. 3A; para [0017]).
Regarding claim 8, Miao as modified, teaches wherein to adjust the laser output setting, the controller circuit is further configured to prioritize adjustments of a pulse shape or a pulse sequencing over an adjustment of an average power of the laser pulses (Watanabe: square pulse train; FIG. 3A; Para [0160]-[0165]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao (US 20150335385) in view of Shelton (US 20180055568) and further in view of Wells (US 20100049180).
Regarding claim 3, Miao does not expressly disclose, wherein the controller circuit is further configured to:
detect, in the images or video frames, a change in intensity of one or more-color components over time associated with the first target in the images or video frames; and
determine whether tissue whitening indicative of thermal damage due to the heat buildup has occurred at the first target based on the detected change in intensity of the one or more-color components.
Wells is directed to systems and methods for laser medical treatments (para [0003]) and teaches wherein the controller circuit is further configured to:
detect, in the images or video frames, a change in intensity of one or more-color components (Tissue whitening due to thermal damage; Imaging and displaying of the whitened tissue can be considered as detecting the change in intensity; para [0216]) over time associated with the first target in the images or video frames; and
determine whether tissue whitening (FIG. 3A; white part of tissue) indicative of thermal damage due to the heat buildup has occurred at the first target based on the detected change in intensity of the one or more-color components (Irreversible thermal tissue damage is observed macroscopically as tissue whitening. FIG. 3A; Para [0216]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Miao to use the whitened image of the tissue due to laser as an indicative of the thermal damage of the tissue so that preventive measures could be done during the surgery such as more irrigation flow for temperature control.
Claim(s) 9-11, 14, 15, is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao (US 20150335385) in view of Shelton (US 20180055568) and further in view of Ma (US 20210330309).
Regarding claim 9, Miao does not expressly disclose an irrigation and/or suction system configured to provide irrigant into, and suction of fluid from, the surgical site.
Ma is directed to managing fluid conditions in a patient (abstract) and teaches an irrigation (an irrigation line 35; FIG. 1; Para [0047]) and/or suction system (active suction is provided; Para [0011]) configured to provide irrigant into, and suction of fluid from (Para [0011]), the surgical site.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Miao in accordance with the teaching of Ma so that an irrigation and suction could be provided to the surgical site so that temperature of the surrounding could be controlled while also maintaining the surgical drainage by way of providing suction in the surgical system.
Regarding claim 10, Miao, as modified, teaches wherein the at least one operating parameter associated with the endoscopic surgical system comprises at least one of an irrigation flow (Ma: Flow in an irrigation line 35; FIG. 1; Para [0047]) or a suction flow associated with an irrigation system (Ma: fluid management cart 30; FIG. 1; para [0047]) and a suction system (Management-related controls 905 (Irrigation and/or suction controls); FIG. 1; para [0143]), respectively.
Regarding claim 11, Miao, as modified, teaches a pressure sensor (Ma: irrigation fluid pressure is determined at least in part by the height of the pressure sensor in the fluid management cart 30; para [0048]) configured to sense a pressure at the surgical site during the procedure, 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 but not the irrigation flow when the sensed pressure exceeds an upper pressure limit (Ma: raising lower limits and/or lowering upper limits) in response to the case-specific pressure sensor signals; Pressure levels are increased or decreased; Para [0147]; When the height is made below the incision in the site 70, the suction takes place.);
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 (Ma: Raising lower limits and/or lowering upper limits) in response to the case-specific pressure sensor signals; Pressure levels are increased or decreased; Para [0147]); and
increase the irrigation flow but not the suction flow when the sensed pressure falls below the lower pressure limit (When the height is made above the incision in the site 70, the irrigation takes place. FIG. 1).
Regarding claim 14, Miao does not expressly disclose wherein the at least one operating parameter associated with the endoscopic surgical system comprises at least one of: temperature of an irrigant before being applied to the surgical site; an irrigation flow rate.
Ma teaches wherein the at least one operating parameter associated with the endoscopic surgical system comprises at least one of: temperature of an irrigant before being applied to the surgical site; an irrigation flow rate (Raising lower limits and/or lowering upper limits) in response to the case-specific pressure sensor signals; Pressure levels are increased or decreased; Para [0147]); a suction flow rate; or a laser output setting of a laser system.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Miao to adjust the flow rate in accordance with the teaching of Ma so that irrigant flow could be controlled during surgery by adjusting height.
Regarding claim 15, Miao, as modified, 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 degree of heat built up in the first target or a pressure at the surgical site (Ma: Raising lower limits and/or lowering upper limits in response to the case-specific pressure sensor signals; Pressure levels are increased or decreased; Para [0147]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao (US 20150335385) in view of Shelton (US 20180055568) and further in view of Ma (US 20210330309).
Regarding claim 12, Miao does not expressly disclose 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 the temperature of the irrigant before reaching the surgical site upon determining that the degree of heat built up in the first target exceeds the predetermined threshold.
Shelton teaches systems and methods for controlling an irrigation flow rate during a lithotripsy procedure (abstract) and teaches an irrigant treatment unit configured to alter a temperature of the irrigant (If the processor indicates that the temperature of the surgical place in the patient's body is high, it can increase the irrigation flow rate to bring the temperature in the acceptable range to prevent or reduce the tissue damage; FIG. 4; Para [0032]), wherein the controller circuit is further configured to generate a control signal to the irrigant treatment unit to adjust the temperature of the irrigant before reaching the surgical site upon determining that the degree of heat built up in the first target exceeds the predetermined threshold ( If the processor indicates that the temperature of the surgical place in the patient's body is high, it can increase the irrigation flow rate to bring the temperature in the acceptable range to prevent or reduce the tissue damage; FIG. 4; Para [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Miao to include a step of controlling the irrigation flow in accordance with the teaching of Shelton so that the temperature at surgical site and surrounding could be controlled.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao (US 20150335385) in view of Shelton (US 20180055568) and further in view of Ingle (US 20100049186), Tanigami (US 20210386270) and Shelton (US 20210038307, hereinafter “Shelton 8307”).
Regarding claim 13, Miao does not expressly disclose 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 surgical site, wherein the controller circuit is further configured to, upon determining that the degree of heat built up in the first target exceeds the predetermined threshold, 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 surgical site.
Shelton 8307 is directed to a medical laser treatment system (abstract) and teaches wherein the endoscopic surgical device includes an optical pathway with an adjustable distal portion (lateral positioning or re-positioning of the distal portion of the laser fiber 140; Para [0061]), the optical pathway configured to direct the laser energy to the surgical site (FIG. 1A), wherein the controller circuit is further configured to, upon determining that the degree of heat built up in the first target exceeds the predetermined threshold, generate a control signal to an actuator (an actuator is not positively recited) coupled to the optical pathway to adjust a position or orientation of the distal portion of the optical pathway relative to the surgical site (By configuring the actuator 185 to be remotely controlled, such as via the control circuitry 120, such lateral positioning or re-positioning of the distal portion of the laser fiber 140 can allow sub-targeting of multiple locations on a target object located near a distal end of the endoscope 110 or other instrument without requiring re-positioning of such endoscope 110 or other instrument. This can be useful to the user to deliver a desired spatiotemporal series or sequence of laser pulses at various desired locations of the target object, including tailoring the energy level of one or more individual laser pulses. Para [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Miao to have an adjustable distal portion in accordance with the teaching of Shelton 8307so that the laser power could be changed as needed by adjusting the pathway of the laser by way of changing position of the laser.
Response to Argument
Applicant’s arguments submitted on 02/27/2026 have been fully considered and are persuasive. Therefore, the rejection dated 11/20/2025 has been withdrawn. However, upon further consideration, a new rejection has been made in view of amendment.
The newly relied upon art Miao (US 20150335385) discloses determining the temperature of the region by infrared imaging and maintaining a temperature of a second target to a specified temperature by supplying the laser energy (Maintaining the temperature of the high-temperature region 154 substantially equal to a specified temperature by laser; Para [0047]; Infrared imaging determines the temperature of the region 154; FIG. 1; para [0005]).
Shelton (US 20180055568) teaches increasing the irrigation flow rate around a first target (around the kidney stone in a surgical region) to bring the temperature in the acceptable range to prevent or reduce the tissue damage (FIG. 4; Para [0032]).
Accordingly, in view of the newly cited art claim 1 is rejected. See rejections set forth above.
Conclusion
THIS ACTION IS MADE FINAL. 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 SHANKAR R GHIMIRE whose telephone number is (571)272-0515. The examiner can normally be reached 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached on 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHANKAR RAJ GHIMIRE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 04/06/26