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 .
Response to Amendment
Amendments to claims 1, 3, 15-19, 20 of 5/5/2025 acknowledged and entered.
New claims 23-31 of 5/5/2025 acknowledged and entered.
Cancellation of claims 4-8, 10-14, 21 of 5/5/2025 acknowledged and entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 19, 20 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 Interpretation
As outlined below in Claim Rejections - 35 USC § 112, examiner finds claims 26 and 29 to be indefinite given the classical definition of the term “reduce turbidity”. For the purposes of examination, examiner chooses to believe that applicant is attempting to be their own lexicographer and use the term “reduce turbidity” to mean “reduce the hindering effect of turbidity on a user”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 26, 29 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “reduce turbidity” in claims 26, 29 is used by the claim to mean “to reduce the negative impact of turbidity on a user,” while the accepted meaning is “to reduce the concentration of obstructive particulate suspended in fluid.” The term is indefinite because the specification does not clearly redefine the term.
Claims 26/29 recite that the first control reduces turbidity. However, claims 19/20 upon which they are dependent define the first control as “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”. The superimposition of a treatment tool is a back end, post processing procedure which does not affect the operating site. The first control, as defined, does not meaningfully alter the fluid at the operating site. In that regard, the first control as defined in claims 19/20 is incapable of actually reducing turbidity without further defining the first control to include another process or procedure that affects the operating site. This renders the claim indefinite, as it is unclear as to how the device as defined by the independent claim accomplishes the process as outlined in the dependent. For the purposes of examination, examiner would interpret the meaning of reducing turbidity to instead be reducing the impact of turbidity on a user’s capacity to perform an operation.
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, in response to a determination to control the turbidity, superimpose an image of an outline of the treatment tool on a visual field image output to a display device.
However, Larkin teaches the device configured to, 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 an image of an outline of the treatment tool 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.
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).
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.
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).
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 reduce 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 reduce 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
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