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 .
Status of Claims
Claims 1-2, 4-7, 9-11, 13-17, and 19-24 are pending, claims 3, 8, 12, and 18 have been cancelled, and claims 1-2, 4-7, 9-11, 13-17, and 19-24 are currently under consideration for patentability under 37 CFR 1.104.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/30/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2, 4-7, 9-11, 13-17, and 19-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 23-24 are objected to because of the following informalities: change “a second flow rate to a third flow rate” to “the second flow rate to a third flow rate” (i.e., the second flow rate was previously recited). Appropriate correction is required.
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) 1-2, 4-6, 11, 13-16, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Finkman (US 2011/0144429) hereafter referred to as “Finkman 11”, in view of Finkman (US 2015/0133728) hereafter referred to as “Finkman 15” and Hamel (US 2011/0237880).
Regarding claim 1, Finkman 11 discloses a method for controlling irrigation flow (see figure 5) during a lithotripsy procedure (ureteroscope…[0024]) comprising: receiving a feedback signal comprising imaging data (CCU 44…measurement of image quality…step 80 [0043]; figure 5); computationally analyzing the received feedback signal to determine at least one imaging characteristic associated with the imaging data (contrast level [0046]); and setting an irrigation flow rate based at least in part on the determined at least one imaging characteristic ([0047]-[0048]; figure 5). Finkman 11 further discloses a tool (70, figure 3), like an optical fiber for delivering laser radiation, inserted through a working channel (38, figure 3). The working channel accommodates a tool that passed through it while fluid is irrigating the target region (claim 4). Finkman 11 is silent regarding fragmenting a calculi target using a lithotripsy-device system; the imaging data from the lithotripsy-device system during the lithotripsy procedure; including starting to increase the irrigation flow rate after the at least one imaging characteristic indicates a sustained blurry image for a predetermined time duration.
Finkman 15 teaches an endoscope (24, figure 1) with an energy guide (optical fiber 36, figure 1) inserted through a working channel (34, figure 1) to disintegrate a stone (28, figure 1). A laser (50, figure 2) is configured to emit a low-power visible beam and a high-power lithotripsy pulses ([0031]). A control unit (56, figure 2) comprises an image processor (60, figure 2) and beam control (58, figure 2). The image processor processes the images output by the imaging assembly, which signals a beam controller ([0033]). The controller (58, figure 2) will allow laser (50, figure 2) to be actuated only when the image processor provides an “enable” signal after verifying that the aiming beam is incident on a stone and may inhibit actuation of the laser otherwise ([0033]).
Hamel teaches a surgical system (figure 1) where the detection of hemoglobin is detected through the video signal output from a video camera ([0006]). The video signal is fed to a signal processor that divides every video line signal into 0.64 microsecond time slots, with this arrangement corresponds to 100 time slots for every video signal line and a picture frame is made up of 625 lines ([0007]). Every picture frame has a score, and a score sum for the ten frames is calculated every time a new frame is delivered by the camera ([0007]). At every new frame, the score value of the oldest frame is discarded, thus introducing an averaging function ([0007]). If during a period of 10 frames the score sum is > 30,000, blood is considered present ([0008]). If the score sum is > 30,000, the video signal processor will signal to an operating control device (17, figure 1) to increasing the flow of the aspiration pump to a higher level ([0009]). If the score sum is > 70,000, the flow will increase to an even higher flow rate ([0009]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the method of Finkman 11 to use an energy guide/optical fiber (36, figure 2), a laser (50, figure 2), and a control unit (56, figure 2) with a beam control (58, figure 2) and image processor (60, figure 2) to disintegrate a stone ([0029]). Doing so would verify a laser beam is incident on the stone prior to actuating the laser on the stone (abstract). Further, it would have been obvious to modify the method of Finkman 11 to use a score sum with an averaging function for the imaging characteristic to increase the irrigation flow rate as taught by Hamel ([0007]). Doing so would increase the irrigation flow rate when blood/debris is consistently present (score sum…averaging function [0007]; blood is considered present [0008]). The modified method would comprise fragmenting a calculi target using a lithotripsy-device system (disintegrate stone [0029]; Finkman 15); the imaging data from the lithotripsy-device system during the lithotripsy procedure (see 32 to 60, figure 2); including starting to increase the irrigation flow rate (increasing the flow of the aspiration pump [0009]; Hamel) after the at least one imaging characteristic indicates a sustained blurry image for a predetermined time duration (score sum for the ten frames…[0007]; Hamel | the modified method would use the contrast below a threshold [0048] of Finkman 11 for scoring).
Regarding claim 2, Finkman 11 further discloses the at least one imaging characteristic includes at least one of a presence or an absence of a sharp edge on an image (contrast…[0043]; Finkman 11), or a transition of grey level among image pixels in a region of the image.
Regarding claim 4, Finkman 11 further discloses the image is determined to be blurry when the at least one imaging characteristic exceeds a blurriness threshold (local contrast is less than threshold L, 88, figure 5 in Finkman 11 | blurry…increase the flow rate [0048] | contrast value indicates the sharpness of the image, if contrast value is less than threshold L, the Examiner interpreted the blurriness is greater than the level of blurriness associated with threshold L).
Regarding claim 5, Finkman 11 further discloses (i) receiving at least one of a predetermined upper threshold irrigation rate (maximum flow 90, figure 5; Finkman 11) or a maximal intra-renal pressure; and(ii) maintaining or adjusting the irrigation flow rate according to the upper threshold irrigation rate (check the irrigation flow rate…if the flow is below a preset maximum value…[0048]) and/or the maximal intra-renal pressure.
Regarding claim 6, Finkman 11 further discloses setting the irrigation flow rate comprises decreasing the irrigation flow rate (decrease irrigation flow 86, figure 5 | Finkman 11) if the at least one imaging characteristic indicates an image being clear (local contrast is greater than threshold H, 82, figure 5 | picture is relatively sharp [0047]).
Regarding claim 11, Finkman 11 discloses a system comprising: a lithotripsy-device system (ureteroscope…[0024]); and an irrigation controller (CCU 44, figure 1) configured to: receive a feedback signal comprising imaging data from the lithotripsy-device system (measurement of image quality…step 80 [0043]; figure 5); computationally analyzing the received feedback signal to determine at least one imaging characteristic associated with the imaging data (contrast level [0046]); and set an irrigation flow rate based at least in part on the determined at least one imaging characteristic ([0047]-[0048]; figure 5). Finkman 11 further discloses a tool (70, figure 3), like an optical fiber for delivering laser radiation, inserted through a working channel (38, figure 3). The working channel accommodates a tool that passed through it while fluid is irrigating the target region (claim 4). Finkman 11 is silent regarding the lithotripsy-device system configured to produce lithotripsy energy to fragment a calculi target; comprising imaging data from the lithotripsy-device system during a lithotripsy procedure, including triggering an irrigation pump to increase the irrigation flow rate after the at least one imaging characteristic indicates a sustained blurry image for a predetermined time duration.
Finkman 15 teaches an endoscope (24, figure 1) with an energy guide (optical fiber 36, figure 1) inserted through a working channel (34, figure 1) to disintegrate a stone (28, figure 1). A laser (50, figure 2) is configured to emit a low-power visible beam and a high-power lithotripsy pulses ([0031]). A control unit (56, figure 2) comprises an image processor (60, figure 2) and beam control (58, figure 2). The image processor processes the images output by the imaging assembly, which signals a beam controller ([0033]). The controller (58, figure 2) will allow laser (50, figure 2) to be actuated only when the image processor provides an “enable” signal after verifying that the aiming beam is incident on a stone and may inhibit actuation of the laser otherwise ([0033]).
Hamel teaches a surgical system (figure 1) where the detection of hemoglobin is detected through the video signal output from a video camera ([0006]). The video signal is fed to a signal processor that divides every video line signal into 0.64 microsecond time slots, with this arrangement corresponds to 100 time slots for every video signal line and a picture frame is made up of 625 lines ([0007]). Every picture frame has a score, and a score sum for the ten frames is calculated every time a new frame is delivered by the camera ([0007]). At every new frame, the score value of the oldest frame is discarded, thus introducing an averaging function ([0007]). If during a period of 10 frames the score sum is >30,000, blood is considered present ([0008]). If the score sum is >30,000, the video signal processor will signal to an operating control device (17, figure 1) to increasing the flow of the aspiration pump to a higher level ([0009]). If the score sum is > 70,000, the flow will increase to an even higher flow rate ([0009]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the system of Finkman 11 to use an energy guide/optical fiber (36, figure 2), a laser (50, figure 2), and a control unit (56, figure 2) with a beam control (58, figure 2) and image processor (60, figure 2) to disintegrate a stone ([0029]). Doing so would verify a laser beam is incident on the stone prior to actuating the laser on the stone (abstract). Further, it would have been obvious to modify the system of Finkman 11 to use a score sum with an averaging function for the imaging characteristic to increase the irrigation flow rate as taught by Hamel ([0007]). Doing so would increase the irrigation flow rate when blood/debris is consistently present (score sum…averaging function [0007]; blood is considered present [0008]). The modified system would comprise the lithotripsy-device system configured to produce lithotripsy energy to fragment a calculi target (disintegrate stone [0029]; Finkman 15); comprising imaging data from the lithotripsy-device system during a lithotripsy procedure (see 32 to 60, figure 2), including triggering an irrigation pump (48, figure 1; Finkman 11) to increase the irrigation flow rate after (increasing the flow of the aspiration pump [0009]; Hamel) the at least one imaging characteristic indicates a sustained blurry image for a predetermined time duration (score sum for the ten frames…[0007]; Hamel | the modified method would use the contrast below a threshold [0048] of Finkman 11 for scoring).
Regarding claim 13, Finkman 11 further discloses the at least one imaging characteristic includes at least one of a presence or an absence of a sharp edge on (contrast…[0043]; Finkman 11), or a transition of grey level among image pixels in a region of the image.
Regarding claim 14, Finkman 11 further discloses the irrigation controller is configured to determine the image being blurry when the at least one imaging characteristic exceed a blurriness threshold (local contrast is less than threshold L, 88, figure 5 in Finkman 11 | blurry…increase the flow rate [0048] | contrast value indicates the sharpness of the image, if contrast value is less than threshold L, the Examiner interpreted the blurriness is greater than the level of blurriness associated with threshold L).
Regarding claim 15, Finkman 11 further discloses the irrigation controller is further configured to receive at least one of a predetermined upper threshold irrigation rate (maximum flow 90, figure 5; Finkman 11) or a maximal intra-renal pressure, and to maintain or adjust the irrigation flow rate according to the upper threshold irrigation rate (check the irrigation flow rate…if the flow is below a preset maximum value…[0048]) and/or the maximal intra-renal pressure.
Regarding claim 16, Finkman 11 further discloses the irrigation controller is further configured to decrease the irrigation flow rate (decrease irrigation flow 86, figure 5 | Finkman 11) if the at least one imaging characteristic indicates an image being clear (local contrast is greater than threshold H, 82, figure 5 | picture is relatively sharp [0047]).
Regarding claim 23, Finkman 11 and Hamel further disclose setting the increase of irrigation flow rate includes: increasing from a first flow rate to a second flow rate (increasing the flow…300 ml/min; [0009]; Hamel) when the at least one imaging characteristic indicates the sustained blurry image for a first predetermined time duration (score sum for the ten frames…[0007]; Hamel | the modified method would use the contrast below a threshold [0048] of Finkman 11 for scoring, where the score sum can be a number that represents the number of frames where a blurry image is detected that is at or below 10 frames | the predetermined time duration can be up to the time associated with 10 frames, as long as the score sum is reached); and increasing from a second flow rate to a third flow rate (if the score sum is >70,000, the flow will increase to 450 ml/min; [0009] Hamel) when the at least one imaging characteristic indicates the sustained blurry image for a second predetermined time duration (score sum for the ten frames…[0007]; Hamel | the higher score sum can be associated with a longer time duration, as long as the time duration is less than the time associated with 10 frames).
Regarding claim 24, Finkman 11 and Hamel further disclose to set the increase of irrigation flow rate, the irrigation controller is configured to: increase from a first flow rate to a second flow rate (increasing the flow…300 ml/min; [0009]; Hamel ) when the at least one imaging characteristic indicates the sustained blurry image for a first predetermined time duration (score sum for the ten frames…[0007]; Hamel | the modified method would use the contrast below a threshold [0048] of Finkman 11 for scoring, where the score sum can be a number that represents the number of frames where a blurry image is detected that is at or below 10 frames | the predetermined time duration can be up to the time associated with 10 frames, as long as the score sum is reached); and increase from a second flow rate to a third flow rate (if the score sum is >70,000, the flow will increase to 450 ml/min; [0009] Hamel) when the at least one imaging characteristic indicates the sustained blurry image for a second predetermined time duration (score sum for the ten frames…[0007]; Hamel | the higher score sum can be associated with a longer time duration, as long as the time duration is less than the time associated with 10 frames).
Claim(s) 7, 9-10, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Finkman (US 2011/0144429) hereafter referred to as “Finkman 11”, in view of Finkman (US 2015/0133728) hereafter referred to as “Finkman 15” and Hamel (US 2011/0237880) and Chia (US 2015/0289937).
Regarding claim 7, Finkman 11 discloses a method for controlling a lithotripsy-device system during a lithotripsy procedure (ureteroscope…[0024]), the method comprising: receiving a feedback signal comprising imaging data from the lithotripsy-device system (CCU 44…measurement of image quality…step 80 [0043]; figure 5); computationally analyzing the received feedback signal to determine at least one imaging characteristic associated with the imaging data (contrast level [0046]). Finkman 11 further discloses a tool (70, figure 3), like an optical fiber for delivering laser radiation, inserted through a working channel (38, figure 3). The working channel accommodates a tool that passed through it while fluid is irrigating the target region (claim 4). Finkman 11 is silent regarding fragmenting a calculi target using the lithotripsy-device system; the imaging data from the lithotripsy-device system during the lithotripsy procedure; and adjusting an operation of the lithotripsy-device system based at least in part on the determined at least one imaging characteristic, including starting to reduce a lithotripsy energy output and continuing fragmenting the calculi target using the reduced energy output after the determined at least one imaging characteristic indicates a sustained blurry image for a predetermined time duration.
Finkman 15 teaches an endoscope (24, figure 1) with an energy guide (optical fiber 36, figure 1) inserted through a working channel (34, figure 1) to disintegrate a stone (28, figure 1). A laser (50, figure 2) is configured to emit a low-power visible beam and a high-power lithotripsy pulses ([0031]). A control unit (56, figure 2) comprises an image processor (60, figure 2) and beam control (58, figure 2). The image processor processes the images output by the imaging assembly, which signals a beam controller ([0033]). The controller (58, figure 2) will allow laser (50, figure 2) to be actuated only when the image processor provides an “enable” signal after verifying that the aiming beam is incident on a stone and may inhibit actuation of the laser otherwise ([0033]).
Hamel teaches a surgical system (figure 1) where the detection of hemoglobin is detected through the video signal output from a video camera ([0006]). The video signal is fed to a signal processor that divides every video line signal into 0.64 microsecond time slots, with this arrangement corresponds to 100 time slots for every video signal line and a picture frame is made up of 625 lines ([0007]). Every picture frame has a score, and a score sum for the ten frames is calculated every time a new frame is delivered by the camera ([0007]). At every new frame, the score value of the oldest frame is discarded, thus introducing an averaging function ([0007]). If during a period of 10 frames the score sum is > 30,000, blood is considered present ([0008]). If the score sum is > 30,000, the video signal processor will signal to an operating control device (17, figure 1) to increasing the flow of the aspiration pump to a higher level ([0009]). If the score sum is > 70,000, the flow will increase to an even higher flow rate ([0009]).
Chia teaches using a characteristic of a targeted stone to determine laser energy settings (see 210-212, figure 8). The characteristic of the stone can be the estimated size of the stone, estimated length of a dimension of the stone, estimated composition of the stone, a vibration frequency of the stone, and type of the stone, which is processed by a controller to generate an output ([0064]). The controller uses mapping to determine the laser energy settings based on the output and a laser generator generates the laser energy ([0065]-[0066]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the method of Finkman 11 to use an energy guide/optical fiber (36, figure 2), a laser (50, figure 2), and a control unit (56, figure 2) with a beam control (58, figure 2) and image processor (60, figure 2) to disintegrate a stone ([0029]). Doing so would verify a laser beam is incident on the stone prior to actuating the laser on the stone (abstract). Further, it would have been obvious to modify the method of Finkman 11 to use a score sum with an averaging function for the imaging characteristic to determine if blood/debris is present as taught by Hamel ([0007]). Doing so would indicate when blood/debris is consistently present (score sum…averaging function [0007]; blood is considered present [0008]). Further, it would have been obvious to use the modify the method of Finkman 11 to use the at least one imaging characteristic associated with the imaging data to determine laser energy setting (212, figure 8) as taught by Chia. Doing so would provide a laser energy setting determined based on the at least one imaging characteristic (see 212, figure 8). The modified method would comprise fragmenting a calculi target using the lithotripsy-device system (disintegrate stone [0029]; Finkman 15); the imaging data from the lithotripsy-device system during the lithotripsy procedure (see 32 to 60, figure 2); and adjusting an operation of the lithotripsy-device system based at least in part on the determined at least one imaging characteristic (inhibit laser…[0044]; Finkman 15 | or determine laser energy settings 212, figure 8; Chia), including starting to reduce a lithotripsy energy output (blood is considered present [0008]; Hamel | determine laser energy settings 212, figure 8; Chia | interpreted the laser energy settings would be continually adjusted based on the imaging characteristic, which would then result in reducing the energy output based on the determination of laser energy settings) and continuing fragmenting the calculi target using the reduced energy output after the determined at least one imaging characteristic indicates a sustained blurry image for a predetermined time duration (score sum for the ten frames…[0007]; Hamel | the modified method would use the contrast below a threshold [0048] of Finkman 11 for scoring).
Regarding claim 9, Finkman 15 and Chia further teach reducing the lithotripsy energy output includes reducing a frequency or a peak pulse power in a laser lithotripter system so as to reduce a rate of fragment generation (inhibit laser…[0044]; Finkman 15 | determine laser energy settings 212, figure 8; Chia | interpreted the laser energy settings would be continually adjusted based on the imaging characteristic, which would then result in reducing the energy output based on the determination of laser energy settings).
Regarding claim 10, Finkman 11 and Finkman 15 further disclose determining or receiving information about an irrigation flow rate for irrigating a procedure site (sensor 42 may measure flow rate [0030]; Finkman 11), wherein the lithotripsy energy output is adjusted in response to a determination that the irrigation flow rate reaches a predetermined value (local contrast is less than threshold L, 88 -> maximum flow 90, figure 5 in Finkman 11; blurry…increase the flow rate [0048] | contrast value indicates the sharpness of the image, if contrast value is less than threshold L, the Examiner interpreted the blurriness is greater than the level of blurriness associated with threshold L | inhibit laser…loss of image [0044]; Finkman 15). The Examiner interpreted that when the blurriness reaches a threshold (or contrast is less than a threshold), the flow rate is set to a maximum flow, the modified method would also adjust the lithotripsy energy output (inhibit…[0044]; Finkman 15).
Regarding claim 17, Finkman 11 discloses a system, comprising: a lithotripsy-device system (ureteroscope…[0024]); and a controller (CCU 44, figure 1) configured to: receive a feedback signal comprising imaging data from the lithotripsy-device system (measurement of image quality…step 80 [0043]; figure 5); computationally analyze the received feedback signal to determine at least one imaging characteristic associated with the imaging data (contrast level [0046]). Finkman 11 further discloses a tool (70, figure 3), like an optical fiber for delivering laser radiation, inserted through a working channel (38, figure 3). The working channel accommodates a tool that passed through it while fluid is irrigating the target region (claim 4). Finkman 11 is silent regarding the lithotripsy-device system configured to produce lithotripsy energy to fragment a calculi target; imaging data from the lithotripsy-device system during a lithotripsy procedure; and adjust an operation of the lithotripsy-device system based at least in part on the determined at least one imaging characteristic, including starting to reduce a lithotripsy energy output and continuing fragmenting the calculi target using the reduced energy output after the determined at least one imaging characteristic indicates a sustained blurry image for a predetermined time duration.
Finkman 15 teaches an endoscope (24, figure 1) with an energy guide (optical fiber 36, figure 1) inserted through a working channel (34, figure 1) to disintegrate a stone (28, figure 1). A laser (50, figure 2) is configured to emit a low-power visible beam and a high-power lithotripsy pulses ([0031]). A control unit (56, figure 2) comprises an image processor (60, figure 2) and beam control (58, figure 2). The image processor processes the images output by the imaging assembly, which signals a beam controller ([0033]). The controller (58, figure 2) will allow laser (50, figure 2) to be actuated only when the image processor provides an “enable” signal after verifying that the aiming beam is incident on a stone and may inhibit actuation of the laser otherwise ([0033]).
Hamel teaches a surgical system (figure 1) where the detection of hemoglobin is detected through the video signal output from a video camera ([0006]). The video signal is fed to a signal processor that divides every video line signal into 0.64 microsecond time slots, with this arrangement corresponds to 100 time slots for every video signal line and a picture frame is made up of 625 lines ([0007]). Every picture frame has a score, and a score sum for the ten frames is calculated every time a new frame is delivered by the camera ([0007]). At every new frame, the score value of the oldest frame is discarded, thus introducing an averaging function ([0007]). If during a period of 10 frames the score sum is > 30,000, blood is considered present ([0008]). If the score sum is > 30,000, the video signal processor will signal to an operating control device (17, figure 1) to increasing the flow of the aspiration pump to a higher level ([0009]). If the score sum is > 70,000, the flow will increase to an even higher flow rate ([0009]).
Chia teaches using a characteristic of a targeted stone to determine laser energy settings (see 210-212, figure 8). The characteristic of the stone can be the estimated size of the stone, estimated length of a dimension of the stone, estimated composition of the stone, a vibration frequency of the stone, and type of the stone, which is processed by a controller to generate an output ([0064]). The controller uses mapping to determine the laser energy settings based on the output and a laser generator generates the laser energy ([0065]-[0066]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the system of Finkman 11 to use an energy guide/optical fiber (36, figure 2), a laser (50, figure 2), and a control unit (56, figure 2) with a beam control (58, figure 2) and image processor (60, figure 2) to disintegrate a stone ([0029]). Doing so would verify a laser beam is incident on the stone prior to actuating the laser on the stone (abstract). Further, it would have been obvious to modify the system of Finkman 11 to use a score sum with an averaging function for the imaging characteristic to determine if blood/debris is present as taught by Hamel ([0007]). Doing so would indicate when blood/debris is consistently present (score sum…averaging function [0007]; blood is considered present [0008]). Further, it would have been obvious to modify the system of Finkman 11 to use the at least one imaging characteristic associated with the imaging data to determine laser energy setting (212, figure 8) as taught by Chia. Doing so would provide a laser energy setting determined based on the at least one imaging characteristic (see 212, figure 8). The modified system would comprise the lithotripsy-device system configured to produce lithotripsy energy to fragment a calculi target (disintegrate stone [0029]; Finkman 15); imaging data from the lithotripsy-device system during a lithotripsy procedure (see 32 to 60, figure 2); and adjust an operation of the lithotripsy-device system based at least in part on the determined at least one imaging characteristic (inhibit laser…[0044]; Finkman 15 | or determine laser energy settings 212, figure 8; Chia), including starting to reduce a lithotripsy energy output (blood is considered present [0008]; Hamel | determine laser energy settings 212, figure 8; Chia | interpreted the laser energy settings would be continually adjusted based on the imaging characteristic, which would then result in reducing the energy output based on the determination of laser energy settings) and continuing fragmenting the calculi target using the reduced energy output after the determined at least one imaging characteristic indicates a sustained blurry image for a predetermined time duration (score sum for the ten frames…[0007]; Hamel | the modified method would use the contrast below a threshold [0048] of Finkman 11 for scoring).
Regarding claim 19, Finkman 15 and Chia further teach to reduce the lithotripsy energy output includes to reduce a frequency or a peak pulse power in a laser lithotripter system so as to reduce a rate of fragment generation (inhibit laser…[0044]; Finkman 15 | determine laser energy settings 212, figure 8; Chia | interpreted the laser energy settings would be continually adjusted based on the imaging characteristic, which would then result in reducing the energy output based on the determination of laser energy settings).
Regarding claim 20, Finkman 11 and Finkman 15 further disclose the controller is configured to determine or receive information about an irrigation flow rate for irrigating a procedure site (sensor 42 may measure flow rate [0030]; Finkman 11), and to adjust the operation of the lithotripsy-device system in response to a determination that the irrigation flow rate reaches a predetermined value (local contrast is less than threshold L, 88 -> maximum flow 90, figure 5 in Finkman 11; blurry…increase the flow rate [0048] | contrast value indicates the sharpness of the image, if contrast value is less than threshold L, the Examiner interpreted the blurriness is greater than the level of blurriness associated with threshold L | inhibit laser…loss of image [0044]; Finkman 15). The Examiner interpreted that when the blurriness reaches a threshold (or contrast is less than a threshold), the flow rate is set to a maximum flow, the modified method would also adjust the lithotripsy energy output (inhibit…[0044]; Finkman 15).
Claim(s) 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Finkman (US 2011/0144429) and Finkman (US 2015/0133728) and Hamel (US 2011/0237880) as applied to claims 1 and 11 above, and further in view of Slenker (US 2008/0167527).
Regarding claim 21, Finkman 11 and Finkman 15 and Hamel disclose all of the features in the current invention as shown above in claim 1. They are silent regarding applying bursts of irrigation at an increased irrigation flow rate or rate range when the determined at least one imaging characteristic indicates a blurry image.
Slenker teaches a surgical biofilm removal system (20, figure 1) with a biofilm removal surgical instrument (22, figure 1), a light source (24, figure 1), a light connector (26, figure 1), a fluid source (28, figure 1), a fluid connector (30, figure 1), a vacuum source (32, figure 1), a vacuum connector (34, figure 1), an imaging device (36, figure 1), an imaging connector (38, figure 1), and a controller (39, figure 1). The controller is in communication with the instrument and the fluid source ([0077]). The controller can be programmed to operate the system according to a variety of desired irrigation and/or aspiration profiles, including ramped actuation, time delays, varied flow patterns, and others ([0077]).
It would have been obvious to modify the method to have a variety of irrigation and/or aspiration profiles as taught by Slenker. Doing so would provide desired irrigation and/or aspiration profiles, such as ramped actuation, time delays, varied flow patterns, and others ([0077]). The modified method would comprise applying bursts of irrigation at an increased irrigation flow rate (pulsed flow…flow pattern…[0085]; Slenker) or rate range when the determined at least one imaging characteristic indicates a blurry image (picture…blurry [0048]; Finkman 11).
Regarding claim 22, Finkman 11 and Finkman 15 and Hamel disclose all of the features in the current invention as shown above in claim 11. They are silent regarding the irrigation controller is further configured to apply bursts of irrigation at an increased irrigation flow rate or rate range when the determined at least one imaging characteristic indicates a blurry image.
Slenker teaches a surgical biofilm removal system (20, figure 1) with a biofilm removal surgical instrument (22, figure 1), a light source (24, figure 1), a light connector (26, figure 1), a fluid source (28, figure 1), a fluid connector (30, figure 1), a vacuum source (32, figure 1), a vacuum connector (34, figure 1), an imaging device (36, figure 1), an imaging connector (38, figure 1), and a controller (39, figure 1). The controller is in communication with the instrument and the fluid source ([0077]). The controller can be programmed to operate the system according to a variety of desired irrigation and/or aspiration profiles, including ramped actuation, time delays, varied flow patterns, and others ([0077]).
It would have been obvious to modify the system to have a variety of irrigation and/or aspiration profiles as taught by Slenker. Doing so would provide desired irrigation and/or aspiration profiles, such as ramped actuation, time delays, varied flow patterns, and others ([0077]). The modified system would have the irrigation controller is further configured to apply bursts of irrigation at an increased irrigation flow rate (pulsed flow…flow pattern…[0085]; Slenker) or rate range when the determined at least one imaging characteristic indicates a blurry image (picture…blurry [0048]; Finkman 11).
Conclusion
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PAMELA F. WU
Examiner
Art Unit 3795
June 23, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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