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 .
Information Disclosure Statement
The information disclosure statement filed 9/10/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Specifically, JPS5334594 is not included with specification body nor drawings.
Response to Amendment
Amendments to claims 1, 19, 20, 26, 29 of 9/18/2025 acknowledged and entered.
Response to Arguments
Applicant’s arguments, see p. 7, para. 3, filed 9/18/2025, with respect to claims 26, 29 have been fully considered and are persuasive. The rejection of 6/20/2025 has been withdrawn.
Applicant's arguments filed 9/18/2025 have been fully considered but they are not persuasive. Regarding p. 9, para. 1, applicant asserts that the device of Larkin does not disclose “an image or the outline of the treatment tool by processing an image acquired in real time”. Examiner is not in accordance. Per para. [0065-67] of Larkin, the display of an image acquired in real time may be modified, i.e. processed, to have a generated representation of the tool when obscured, specific examples including a line drawing, i.e. an outline. The position and generation of this outline image is based on the captured image as obtained in real time. Specifically, the terms “based on” and “processing” allow for a broader interpretation of the processes than outlined in the remarks. Examiner is not inclined to agree that the amendments made overcome the references cited in the standing rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-3, 9, 15-20, 22, 23, 25, 26, 28, 29, 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 20180055568 A1) in view of Larkin (US 20090192523 A1).
Regarding claim 1, Shelton teaches A surgical system (fig. 4, element 40) comprising:
a controller (fig. 4, element 12; [0032], processor receives feedback to include image processing data) configured to:
detect turbidity information relating to turbidity in the liquid based on luminance, the turbidity occurring due to a treatment tool device ([0022], Transitions of grey level among image pixels in a region is the luminance value independent of color. Contrast also disclosed, which is a measurement based upon the difference in luminance. Stone debris cloud cited as a potential turbulence source, which occurs due to the lithotripsy device treatment);
determine whether to control the turbidity based on the turbidity information ([0032], processor increases irrigation flow rate only when image processing data indicates a blurry image);
Shelton does not explicitly teach the device configured to detect an outline of the treatment tool based on an image acquired in real time;
Generate an image of the outline of the treatment tool by processing the image acquired in real time; and
in response to a determination to control the turbidity, superimpose the image of the outline of the treatment tool where the outline of the treatment tool is detected on a visual field image output to a display device.
However, Larkin teaches the device configured to detect an outline of the treatment tool based on an image acquired in real time ([0065-67], synthetic tool is overlaid onto a real time image of the treatment site);
Generate an image of the outline of the treatment tool by processing the image acquired in real time ([0065-67], synthetic tool is overlaid onto a real time image of the treatment site); and
in response to a determination to control the turbidity (fig. 11, element 1109, [0066], in step 1109 under determination that an end effector is not visible due to obstruction by cauterization smoke or blood, display of a synthetic tool may be superimposed in the display in step 1110), superimpose the image of the outline of the treatment tool where the outline of the treatment tool is detected on a visual field image output to a display device.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Shelton to superimpose an image of a treatment tool in response to turbidity as taught in Larkin in order to provide an operator with visual feedback information regarding the tool’s location and orientation (Larkin [0066]).
Regarding claim 2, Shelton in view of Larkin teaches The surgical system according to claim 1,
Further, Shelton teaches the device wherein the turbidity information is a value that is increased or decreased in correlation with the occurrence of turbidity ([0022] turbidity is determined by contrast or luminance. Data is stored as a value that is tracked against a threshold where the irrigation automatically turns on).
Regarding Claim 3, Shelton in view of Larkin teaches The surgical system according to claim 1,
Further, Shelton teaches the device further comprising a treatment tool device configured to perform a treatment on a biological tissue in a liquid ([0032] Lithotripsy system 40 including endoscope 20)
wherein the turbidity information regarding the turbidity is information caused by treatment of the biological tissue ([0022], Stone debris cloud cited as a potential turbulence source, which occurs due to the lithotripsy device treatment)).
Regarding Claim 9, Shelton in view of Larkin teaches The surgical system according to claim 1,
Further, Shelton teaches the device wherein The controller is further configured to detect the turbidity information from the liquid ([0022], Transitions of grey level among image pixels in a region is the luminance value independent of color. Contrast also disclosed, which is a measurement based upon the difference in luminance).
Regarding Claim 15, Shelton in view of Larkin teaches The surgical system according to claim 23,
Further, Shelton teaches the device wherein the reducing of the turbidity includes increasing drive power of the treatment tool device ([0032], processor can control energy supplied to the lithotripsy device 18 in the event that flow rate is above a threshold. [0004], ultrasound is a known method of lithotripsy).
Regarding Claim 16, Shelton in view of Larkin teaches The surgical system according to claim 23,
Shelton teaches the device further comprising a perfusion device (fig. 4, element 19) configured to supply the liquid ([0032], saline introduced to patient’s body through pump 19),
the reducing of the turbidity includes transmitting a signal configured to increase a supply speed of the liquid to the perfusion device ([0032], processor increases irrigation flow rate).
Regarding claim 17, Shelton in view of Larkin teaches The surgical system according to claim 23,
Further, Shelton teaches the device further comprising a perfusion device configured to perform suction of the liquid (fig. 4, element ACCESS SHEATH, [0021], access sheath allows for outflow of fluid),
The reducing of the turbidity includes transmitting a signal configured to increase a suction amount of the liquid to the perfusion device ([0021], processor can control rate of irrigation inflow and outflow to control the net irrigation rate).
Regarding Claim 18, Shelton in view of Larkin teaches The surgical system according to claim 23,
Further, Shelton teaches the device further comprising a perfusion device (fig. 4, element 19) configured to supply and suction the liquid ([0032], saline introduced to patient’s body through pump 19; fig. 4, element ACCESS SHEATH, [0021], access sheath allows for outflow of fluid), wherein:
the reducing of the turbidity includes transmitting a signal configured to increase a supply amount of the liquid to the perfusion device ([0032], processor increases irrigation flow rate),
and transmitting a signal configured to increase a suction amount of the liquid to the perfusion device ([0021], processor can control rate of irrigation inflow and outflow to control the net irrigation rate).
Regarding Claim 19, Shelton teaches A surgical system comprising:
an endoscope (fig. 4, element 20; [0032] Lithotripsy system 40 including endoscope 20);
a perfusion device (fig. 4, element 19) configured to supply a perfusate to a treatment target ([0032], saline introduced to patient’s body through pump 19);
a treatment tool device (fig. 4, element 18) configured to perform a treatment on a biological tissue in the perfusate in the treatment target ([0032] Lithotripsy system 40 including lithotripsy device 18); and
a controller (fig. 4, element 12; [0032], processor receives feedback to include image processing data) configured to control the endoscope, the treatment tool device, or the perfusion device ([0032], processor increases irrigation flow rate only when image processing data indicates a blurry image), the controller being configured to:
detect whether the perfusate is turbid based on luminance ([0032], processor increases irrigation flow rate only when image processing data indicates a blurry image),
perform a second control in response to detecting that the perfusate is not turbid ([0022], processor decreases irrigation flow rate when field of view becomes clear).
Shelton does not explicitly teach the device configured to perform a first control in response to detecting that the perfusate is turbid, the first control configured to superimpose an image of an outline of the treatment tool on a visual field image output to a display device when the perfusate is turbid,
detect an outline of the treatment tool based on an image acquired in real time;
Generate an image of the outline of the treatment tool by processing the image acquired in real time; and
in response to a determination to control the turbidity, superimpose the image of the outline of the treatment tool where the outline of the treatment tool is detected on a visual field image output to a display device.
However, Larkin teaches the device configured to perform a first control in response to detecting that the perfusate is turbid, the first control configured to superimpose an image of an outline of the treatment tool on a visual field image output to a display device when the perfusate is turbid (fig. 11, element 1109, [0066], in step 1109 under determination that an end effector is not visible due to obstruction by cauterization smoke or blood, display of a synthetic tool may be superimposed in the display in step 1110),
detect an outline of the treatment tool based on an image acquired in real time ([0065-67], synthetic tool is overlaid onto a real time image of the treatment site);
Generate an image of the outline of the treatment tool by processing the image acquired in real time ([0065-67], synthetic tool is overlaid onto a real time image of the treatment site); and
in response to a determination to control the turbidity (fig. 11, element 1109, [0066], in step 1109 under determination that an end effector is not visible due to obstruction by cauterization smoke or blood, display of a synthetic tool may be superimposed in the display in step 1110), superimpose the image of the outline of the treatment tool where the outline of the treatment tool is detected on a visual field image output to a display device.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Shelton to superimpose an image of a treatment tool in response to turbidity as taught in Larkin in order to provide an operator with visual feedback information regarding the tool’s location and orientation (Larkin [0066]).
Regarding Claim 20, Shelton teaches A control device comprising:
at least one control device (fig. 4, element 12; [0032], processor receives feedback to include image processing data) configured to:
receive information from an endoscope device or a treatment tool device (fig. 4, element 12; [0032], processor receives feedback to include image processing data,
detect whether a perfusate is turbid based on the received information ([0032], processor increases irrigation flow rate only when image processing data indicates a blurry image), luminance of an image acquired by an endoscope ([0022], Transitions of grey level among image pixels in a region is the luminance value independent of color. Contrast also disclosed, which is a measurement based upon the difference in luminance),
perform a second control in response to detecting that the perfusate is not turbid ([0022], processor decreases irrigation flow rate when field of view becomes clear).
Shelton does not explicitly teach the device configured to perform a first control in response to detecting that the perfusate is turbid, the first control being configured to superimpose an image of an outline of the treatment tool on a visual field image output to a display device when the perfusate is turbid,
detect an outline of the treatment tool based on an image acquired in real time;
Generate an image of the outline of the treatment tool by processing the image acquired in real time; and
in response to a determination to control the turbidity, superimpose the image of the outline of the treatment tool where the outline of the treatment tool is detected on a visual field image output to a display device.
However, Larkin teaches the device configured to perform a first control in response to detecting that the perfusate is turbid, the first control being configured to superimpose an image of an outline of the treatment tool on a visual field image output to a display device when the perfusate is turbid (fig. 11, element 1109, [0066], in step 1109 under determination that an end effector is not visible due to obstruction by cauterization smoke or blood, display of a synthetic tool may be superimposed in the display in step 1110),
detect an outline of the treatment tool based on an image acquired in real time ([0065-67], synthetic tool is overlaid onto a real time image of the treatment site);
Generate an image of the outline of the treatment tool by processing the image acquired in real time ([0065-67], synthetic tool is overlaid onto a real time image of the treatment site); and
in response to a determination to control the turbidity (fig. 11, element 1109, [0066], in step 1109 under determination that an end effector is not visible due to obstruction by cauterization smoke or blood, display of a synthetic tool may be superimposed in the display in step 1110), superimpose the image of the outline of the treatment tool where the outline of the treatment tool is detected on a visual field image output to a display device.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Shelton to superimpose an image of a treatment tool in response to turbidity as taught in Larkin in order to provide an operator with visual feedback information regarding the tool’s location and orientation (Larkin [0066]).
Regarding claim 22, Shelton in view of Larkin teaches The control device according to claim 20,
Further, Shelton teaches the device further comprising a display device (fig. 4, element 16, [0021]) being connectable to an endoscope device or a treatment tool device.
Regarding claim 23, Shelton in view of Larkin teaches The surgical system according to claim 1,
Further, Shelton teaches the device wherein the controller is configured to, in response to a determination to control the turbidity, reduce the turbidity ([0032], increased irrigation flow rate has the intention to clear the field of view).
Regarding claim 25, Shelton in view of Larkin teaches The surgical system according to claim 1,
Further, Shelton teaches the device wherein the controller is configured to detect turbidity information relating to turbidity in the liquid without depending on a color of an illumination of an endoscope ([0022], Transitions of grey level among image pixels in a region is the luminance value independent of color. Contrast also disclosed, which is a measurement based upon the difference in luminance. Stone debris cloud cited as a potential turbulence source, which occurs due to the lithotripsy device treatment).
Regarding claim 26, Shelton in view of Larkin teaches The surgical system according to claim 19,
Further, Larkin teaches the device wherein the first control is configured to cope with turbidity (fig. 11, element 1109, [0066], in step 1109 under determination that an end effector is not visible due to obstruction by cauterization smoke or blood, display of a synthetic tool may be superimposed in the display in step 1110).
Regarding claim 28, Shelton in view of Larkin teaches The surgical system according to claim 19,
Further, Shelton teaches the device wherein the controller is configured to detect turbidity information relating to turbidity in liquid without depending on a color of an illumination of an endoscope ([0022], Transitions of grey level among image pixels in a region is the luminance value independent of color. Contrast also disclosed, which is a measurement based upon the difference in luminance. Stone debris cloud cited as a potential turbulence source, which occurs due to the lithotripsy device treatment).
Regarding claim 29, Shelton in view of Larkin teaches The control device according to claim 20,
Further, Larkin teaches the device wherein the first control is configured to cope with turbidity (fig. 11, element 1109, [0066], in step 1109 under determination that an end effector is not visible due to obstruction by cauterization smoke or blood, display of a synthetic tool may be superimposed in the display in step 1110).
Regarding claim 31, Shelton in view of Larkin teaches The control device according to claim 20,
Further, Shelton teaches the device wherein the at least one control device is configured to detect whether the perfusate is turbid without depending on a color of an illumination of the endoscope device ([0022], Transitions of grey level among image pixels in a region is the luminance value independent of color. Contrast also disclosed, which is a measurement based upon the difference in luminance. Stone debris cloud cited as a potential turbulence source, which occurs due to the lithotripsy device treatment).
Claim(s) 24, 27, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Larkin as applied to claims 1, 19, 20 in view of Street (US 20220079424 A1).
Regarding claim 24, Shelton in view of Larkin teaches The surgical system according to claim 1,
Shelton in view of Larkin does not explicitly teach the device wherein the controller is configured to, in response to a determination to control the turbidity, superimpose an image of an outline of a biological tissue on the visual field image when a perfusate is turbid.
However, Street teaches the device wherein the controller is configured to, in response to a determination to control the turbidity, superimpose an image of an outline of a biological tissue on the visual field image when a perfusate is turbid ([0150] the controller can highlight the edges of anatomical features and overlay them onto the video feed).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Shelton to include edge highlighting features in order to avoid collisions and better help surgeons estimate depth and understand the surgical site (Street [0151]).
Regarding claim 27, Shelton in view of Larkin teaches The surgical system according to claim 19,
Shelton in view of Larkin does not explicitly teach the device wherein the first control is configured to superimpose an image of an outline of the biological tissue on the visual field image when the perfusate is turbid.
However, Street teaches the device wherein the first control is configured to superimpose an image of an outline of the biological tissue on the visual field image when the perfusate is turbid ([0150] the controller can highlight the edges of anatomical features and overlay them onto the video feed).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Shelton to include edge highlighting features in order to avoid collisions and better help surgeons estimate depth and understand the surgical site (Street [0151]).
Regarding claim 30, Shelton in view of Larkin teaches The control device according to claim 20,
Shelton in view of Larkin does not explicitly teach the device wherein the first control is configured to superimpose an image of an outline of biological tissue on the visual field image when the perfusate is turbid.
However, Street teaches the device wherein the first control is configured to superimpose an image of an outline of biological tissue on the visual field image when the perfusate is turbid ([0150] the controller can highlight the edges of anatomical features and overlay them onto the video feed).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Shelton to include edge highlighting features in order to avoid collisions and better help surgeons estimate depth and understand the surgical site (Street [0151]).
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 TIMOTHY TUAN LUU whose telephone number is (703)756-4592. The examiner can normally be reached Monday-Tuesday, Thursday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached on 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY TUAN LUU/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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