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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/05/2026 has been entered.
Response to Amendment
The amendment filed on 06/05/2026 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 Claims 16-26 are withdrawn from further consideration.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 06/05/2026 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 5, 9-10, is/are rejected under 35 U.S.C. 102 as being anticipated by Kulstad (US 20210145534).
Regarding claim 1, Kulstad discloses endoscopic surgical system (system 100), comprising:
an endoscopic surgical device (ablation device 104; Para [0216]; thermal imaging element; para [0106], [0197]), controllably coupled to a medical instrument for delivering energy to a surgical site in accordance with at least one operating parameter (Flow rate of the fluid is controlled to maintain the temperature of the adjacent site. Para [0135]) to achieve a specific treatment effect of a second target at the surgical site during a procedure;
an imaging sensor (The location sensing element 240 is a thermal imaging element utilized to collect image(s) that enable an operator to identify the esophageal tissue adjacent to the ablation site based upon that esophageal tissue relative to the temperature(s) of other portions of the esophagus. Para [0205], [0216]) configured to generate images or video frames of at least a portion of the surgical site during the procedure; and
a controller (controller 114) circuit configured to:
analyze the generated images or video frames to determine whether a degree of heat built up in a first target at the surgical site (The area adjacent to the ablation site; para [0135]), different than the second target (The ablation site which is inside the first target site; para [0135]), exceeds a predetermined threshold (The sensing elements 710 include any other type of sensing element(s) configured to collect esophageal data of the esophagus 506 that facilitates the esophageal controller 114 in determining the temperature setting and/or the flow rate setting for the fluid flowing through the esophageal heat transfer device 108. Para [0216]); and
based on the determination, determine whether to adjust the at least one operating parameter associated with the endoscopic surgical system (Flow rate of the fluid is set for maintaining a temperature of the target. Para [0135]) so as to substantially maintain the specific treatment effect of the second target at the surgical site while avoiding damaging the first target due to heat buildup during the procedure, wherein the heat buildup at the first target is an unintended thermal effect occurring outside the second target at which the treatment effect is intended (A flow rate setting for fluid flowing through the esophageal heat transfer device to maintain a target temperature of esophageal tissue adjacent to the ablation site via a heat transfer. Abstract; para [0135]).
Regarding claim 5, Kulstad discloses 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 (Thermal imaging element 712; Para [0216]; Thermal imaging can provide a rate of heat buildup.); and adjust the at least one operating parameter associated with the endoscopic surgical system in accordance with the determined degree (A flow rate setting for fluid flowing through the esophageal heat transfer device to maintain a target temperature of esophageal tissue adjacent to the ablation site via a heat transfer region. Abstract; para [0135]).
Regarding claim 9, Kulstad discloses an irrigation and/or suction system configured to provide irrigant into, and suction of fluid from, the surgical site (Provide a flow rate to control temperature; FIG. 8; para [0216]).
Regarding claim 10, Kulstad discloses wherein the at least one operating parameter associated with the endoscopic surgical system comprises at least one of an irrigation flow (Provide a flow rate to control temperature; FIG. 8; para [0216]) associated with an irrigation system.
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) 11, 14, 15, is/are rejected under 35 U.S.C. 103 as being unpatentable over Kulstad (US 20210145534) and further in view of Ma (US 20210330309).
Regarding claim 11, Kulstad does not expressly disclose a pressure sensor 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; 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 but not the suction flow when the sensed pressure falls below the lower pressure limit.
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 and further teaches a pressure sensor (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 (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 (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).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kulstad to adjust the flow rate in accordance with the teaching of Ma so that irrigant flow could be controlled during surgery by adjusting height to control the temperature of area around the surgical site.
Regarding claim 14, Kulstad 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; a suction flow rate; or a laser output setting of a laser system.
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 modify Kulstad to adjust the flow rate in accordance with the teaching of Ma so that irrigant flow could be controlled during surgery by adjusting height to control the temperature of area around the surgical site.
Regarding claim 15, Kulstad, 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 Kulstad (US 20210145534) in view of Shelton (US 20180055568).
Regarding claim 12, Kulstad 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 surgical 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 modify Kulstad to include a step of controlling the irrigation flow in accordance with the teaching of Shelton so that the temperature at surgical site and area surrounding the site could be controlled.
Response to Argument
Applicant’s arguments submitted on 06/05/2026 have been fully considered and are persuasive. Therefore, the rejection dated 04/09/2026 has been withdrawn. However, upon further consideration, a new rejection has been made in view of amendment.
See rejection set forth above.
Reasons for Allowance
Claim 2
The following is an examiner’s statement of reasons for allowance:
The prior art of record fails to explicitly teach or fairly suggest, alone or in combination, an endoscopic surgical system, 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, along with the remaining features of claim 2.
The closest art Kulstad (US 20210145534) could not be modified to be used with urinary system for delivering laser energy to treat the calculi target at the surgical site.
Accordingly, claim 2 is allowed.
Claim 3
The following is an examiner’s statement of reasons for allowance:
The prior art of record fails to explicitly teach or fairly suggest, alone or in combination, an endoscopic surgical system, wherein the controller circuit is further configured to: 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, along with the remaining features of claim 3.
The closest art Kulstad (US 20210145534) could not be further modified to include tissue whitening indicative of thermal damage due to the heat buildup.
Accordingly, claim 3 is allowed.
Claim 4
The following is an examiner’s statement of reasons for allowance:
The prior art of record fails to explicitly teach or fairly suggest, alone or in combination,
an endoscopic surgical system, wherein
an endoscopic surgical device is configured to direct an aiming beam from a light source to the surgical site, the aiming beam having a characteristic color component; and the controller circuit is further configured to identify a footprint of the aiming beam in the generated images or video frames, 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, along with the remaining features of claim 4.
The closest art Kulstad (US 20210145534) could not be further modified to include an aiming beam having a characteristic color component.
Accordingly, claim 4 is allowed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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 at 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
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
8/21/26
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