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 .
Claim Objections
Claim 1, 5 – 8, 10 – 15 and 17 are objected to because of the following informalities:
Claim 1 line 8 - 9, limitation "a positioning of an interventional tool" should read "a position of an interventional tool".
Claim 1 line 11 - 12, limitation "a position of the interventional tool" should read "the position of the interventional tool".
Claim 1 line 14, limitation "the user-interface device" should read "the user interface device".
Claim 1 line 18, limitation "a CT imaging apparatus" should read "the CT imaging apparatus".
Claim 1 line 21, limitation "the user-interface device" should read "the user interface device".
Claim 1 line 22, limitation "the user interface" should read "the user interface device".
Claim 5 line 2 - 3, limitation "a CT imaging apparatus" should read "the CT imaging apparatus".
Claim 5 line 3, limitation "a CT imaging apparatus" should read "the CT imaging apparatus".
Claim 6 line 2, limitation "a position of the interventional tool" should read "the position of the interventional tool".
Claim 7 line 3, limitation "the skin" should read "a skin surface of the subject".
Claim 8 line 4, limitation "through the body" should read "through a body of the subject".
Claim 10 line 5, limitation "the same patient" should read "the saem subject".
Claim 11 line 2 - 6, limitation "one or more of: real time endoscopic imaging data from an endoscopic imaging system; real-time ultrasound imaging data from an ultrasound imaging system; real-time fluoroscopic imaging data from a cone-beam CT imaging apparatus," should read "one or more of: real time endoscopic imaging data from an endoscopic imaging system, real-time ultrasound imaging data from an ultrasound imaging system, or real-time fluoroscopic imaging data from a cone-beam CT imaging apparatus;".
Claim 12 line 5, limitation "a user interface device" should read "the user interface device".
Claim 13 line 2, limitation “a processing unit in accordance with claim 1” should read “the processing unit in accordance with claim 1”.
Claim 14 line 4 - 5, limitation "a positioning of an interventional tool within the body of a patient" should read "the positioning of the interventional tool within a body of the subject".
Claim 15 line 7 - 8, limitation "a positioning of an interventional tool" should read "a position of an interventional tool".
Claim 15 line 10 - 11, limitation "a position of the interventional tool" should read "the position of the interventional tool".
Claim 15 line 13, limitation "the user-interface device" should read "the user interface device".
Claim 15 line 17, limitation "a CT imaging apparatus" should read "the CT imaging apparatus".
Claim 15 line 20, limitation "the user-interface device" should read "the user interface device".
Claim 15 line 21, limitation "the user interface" should read "the user interface device".
Claim 17 line 2, limitation "provide" should read "are configured to provide".
Claim 17 line 3, limitation "the tool" should read "the interventional tool".
Appropriate correction is required.
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.
Claim 1 – 14, 17 and 18 are 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.
Claim 1 recites “A processing unit comprising one or more processors … the method comprising” in line 1 – 2. Claim is an apparatus claim but the main body of claim is reciting method steps. It is unclear whether an apparatus or a method is actually claimed. For a computer-implemented invention, it is highly suggested to use the phrase such as “A processing unit comprising one or more processors … the one or more processors are configured to”. And change the claim body language to apparatus claim phrases correspondingly.
Claim 2 and claim 8 recite similar phrases, and is also suggested to changed the language to apparatus claim phrases.
Claim 4 recites the limitation "during the further iteration of the image guidance phase" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites limitation "the entry point of the kidney" in line 4 – 5. It is unclear the above entry point is the “planned entry point of the kidney” as recited in claim 8 line 3, or the “pre-defined entry point of the kidney” as recited in claim 7 line 4.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable entry point.
Claim 18 recites limitation "a communication interface" in line 1 – 2, it is unclear the above interface is a newly introduced different communication interface or same communication interface as recited in claim 12 line 2, since claim 18 is dependent on claim 12.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable communication interface.
Therefore, claim 1, 2, 4, 8, 18 and all corresponding dependent claim 3, 5 – 7, 9 – 14 and 17 are rejected under 35 U.S.C. 112(b) as being indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 16 is directed to “A computer program product”. See Microsoft Corp. v. AT&T Corp., 550 U.S. 437, 449, 82 USPQ2d 1400, 1407 (2007); see also Benson, 409 U.S. 67, 175 USPQ2d 675 (An "idea" is not patent eligible). Thus, a product claim to a software program that does not also contain at least one structural limitation (such as a “means plus function” limitation) has no physical or tangible form, and thus does not fall within any statutory category. See MPEP 2106.03.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 – 10 and 12 – 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gururaj et al. (US 2022/0000565 A1; published on 01/06/2022) (hereinafter "Gururaj") in view of Kingma et al. (Intraoperative cone beam computed tomography for detecting residual stones in percutaneous nephrolithotomy: a feasibility study; published on 03/08/2021) (hereinafter "Kingma").
Regarding claim 1, Gururaj teaches a processing unit comprising one or more processors configured to perform a computer-implemented method ("… the computing unit comprising one or more processors configured to execute one or more instructions stored in a memory of the computing unit …" [0019]) for interventional support during a renal interventional procedure for kidney stone removal ("… a system for renal puncturing assistance in a percutaneous nephrolithotomy (PCNL) surgery ..." [0019]; by definition, PCNL is a minimally invasive surgical procedure to remove large kidney stones), the method comprising:
at least one intra-operative image acquisition phase ("… an image acquisition unit configured to collect a second set of images of the predetermined area of the patient in real-time during the PCNL, surgery …" [0019]), comprising:
receiving X-ray image data ("… the image acquisition unit may comprise any or a combination of ... at least one fluoroscopic imaging unit ..." [0028]) of an anatomical area which includes at least a portion of a kidney of a subject ("... with real time intra-operative images acquired using image acquisition unit in the end effector, and the AR engine can be used along with an artificial intelligence (AI) engine for any or a combination of: identifying kidney and rib position of the patient" [0102]);
an interventional image guidance phase ("… the image acquisition unit may be configured to monitor real-time position of the at least one needle and the guide wire during the PCNL surgery …" [0025]), comprising:
receiving real-time tool tracking data indicative of a positioning of an interventional tool for use in the interventional procedure ("… the image acquisition unit may be configured to monitor real-time position of the at least one needle and the guide wire during the PCNL surgery …" [0025]),
generating real-time guidance imagery based on the CT image data ("… and wherein the computing unit may be configured to provide augmented reality of the positions of the at least one needle and the guide wire to the user during the PCNL surgery." [0025]; "The computing unit 508 can receive positional data pertaining to the needle/guide wire by means of the image acquisition unit 520 ..." [0123]), and further based on the tracking data, the guidance imagery visualizing a position of the interventional tool relative to the anatomical area imaged in the CT image data ("… the image acquisition unit may be configured to monitor real-time position of the at least one needle and the guide wire during the PCNL surgery …" [0025]; "… overlay the first set of images during the pre-operative CT scan data on real time second set of images of the patient being acquired during the PCNL, surgery to create augmented reality …" [0123]),
communicating with a user interface device to display the generated guidance imagery in real time on a display unit of the user-interface device ("… to provide augmented reality of the positions of the at least one needle and the guide wire to the user during the PCNL surgery." [0025]; "The display unit can be configured to display augmented reality …" [0056]).
Although Gururaj does not explicitly teach the image acquisition unit for intra-operative imaging is a CT imaging unit, the taught image acquisition unit is X-ray based fluoroscopy system which can be used to perform tomographic imaging. Gururaj also fails to explicitly teach a quality assurance check phase, following the interventional image guidance phase, comprising: communicating with a CT imaging apparatus to acquire further CT image data of said anatomical area using a CT imaging apparatus, for use in visualizing any residual stones or stone fragments, for use thereby in determining whether complete stone removal has been achieved, wherein the further CT image data is cone beam CT image data, and communicating with the user-interface device to display the further CT image data on the display unit of the user interface.
However, in the same field of endeavor, Kingma teaches computed tomography (CT) is suitable for intra-operative image acquisition ("CBCT allows for intraoperative high-resolution cross-sectional and three-dimensional imaging." Page 552), This will apply to all other limitations with respect to intra-operative CT imaging in later dependent claims.
Kingma further teaches a quality assurance check phase, following the interventional image guidance phase ("A CBCT-scan was made at the end of the procedure, where the urologist thought to have obtained a stone-free status by means of nephroscopy …" Page 552), comprising:
communicating with a CT imaging apparatus to acquire further CT image data of said anatomical area using a CT imaging apparatus, for use in visualizing any residual stones or stone fragments, for use thereby in determining whether complete stone removal has been achieved ("A CBCT-scan was made at the end of the procedure … any residual fragments imaged on the CBCT-scan could then still be attempted to be extracted in a continued procedure, after re-introducing the sheath and nephroscope … Two definitions of a stone-free status were used; fully stone-free with no residual fragments on follow-up CT and as is common in literature, a definition of stone-free with residual fragments ≤ 4 mm in maximum diameter." Page 552), wherein the further CT image data is cone beam CT image data ("An image modality that could facilitate the intraoperative assessment of the stone-free status is cone beam computed tomography (CBCT)." Page 552; "A CBCT-scan was made at the end of the procedure …" Page 552), and
communicating with the user-interface device to display the further CT image data on the display unit of the user interface (see Fig.1 and Fig.2).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the image acquisition and corresponding procedure as taught by Gururaj with CBCT in kidney procedure as taught by Kingma. It is "for the purpose of removing additional stone fragments" to utilize the high image quality of "the CBCT-scanner in detecting the residual fragments intraoperatively" (see Kingma; Page 555).
Regarding claim 2, Gururaj in view of Kingma teaches all claim limitations, as applied in claim 1, and Kingma further teaches wherein the method further comprises: obtaining an indication of a result of the quality assurance check ("After interpretation, any residual fragments imaged on the CBCT-scan could then still be attempted to be extracted in a continued procedure, after re-introducing the sheath and nephroscope." Page 552); and
responsive to the result of the quality assurance check indicating incomplete stone removal, controlling execution of a further iteration of the interventional image-guidance phase, and subsequently a further execution of the quality assurance check phase ("With these images, any visualized residual fragments can still be attempted to be removed within the same procedure." Page 552; the same procedure includes the procedure steps as taught by Gururaj).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the image acquisition and corresponding procedure as taught by Gururaj with CBCT in kidney procedure as taught by Kingma. It is "for the purpose of removing additional stone fragments" to utilize the high image quality of "the CBCT-scanner in detecting the residual fragments intraoperatively" (see Kingma; Page 555).
Regarding claim 3, Gururaj in view of Kingma teaches all claim limitations, as applied in claim 2, and Kingma further teaches wherein the indication of the result of the quality assurance check is obtained based on a user input received at the user interface device ("After interpretation, any residual fragments imaged on the CBCT-scan could then still be attempted to be extracted in a continued procedure, after re-introducing the sheath and nephroscope." Page 552; this depends on surgeon's decision).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the image acquisition and corresponding procedure as taught by Gururaj with CBCT in kidney procedure as taught by Kingma. It is "for the purpose of removing additional stone fragments" to utilize the high image quality of "the CBCT-scanner in detecting the residual fragments intraoperatively" (see Kingma; Page 555).
Regarding claim 4, Gururaj in view of Kingma teaches all claim limitations, as applied in claim 1, and Kingma further teaches wherein the quality assurance check phase comprises: obtaining, based on user input ("After interpretation, any residual fragments imaged on the CBCT-scan could then still be attempted to be extracted in a continued procedure, after re-introducing the sheath and nephroscope." Page 552; this depends on surgeon's decision); and
wherein, during the further iteration of the image guidance phase, the guidance imagery includes a visualization of the location information associated with residual stones (see Fig.3).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the image acquisition and corresponding procedure as taught by Gururaj with CBCT in kidney procedure as taught by Kingma. It is "for the purpose of removing additional stone fragments" to utilize the high image quality of "the CBCT-scanner in detecting the residual fragments intraoperatively" (see Kingma; Page 555).
Regarding claim 5, Gururaj in view of Kingma teaches all claim limitations, as applied in claim 1, and Gururaj further teaches wherein the at least one intra-operative image acquisition phase comprises communicating with an imaging apparatus to acquire image data of said anatomical area using the imaging apparatus ("... a computing unit operatively coupled to the image acquisition unit, the computing unit comprising one or more processors configured to execute one or more instructions stored in a memory of the computing unit and configured to receive the first set of images and the second set of images associated with the predetermined position ..." [0019]).
In addition, Kingma teaches cone beam computed tomography (CT) is suitable for intra-operative image acquisition ("CBCT allows for intraoperative high-resolution cross-sectional and three-dimensional imaging." Page 552). This will apply to all other limitations with respect to intra-operative CT imaging in later dependent claims.
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the image acquisition and corresponding procedure as taught by Gururaj with CBCT in kidney procedure as taught by Kingma. It is "for the purpose of removing additional stone fragments" to utilize the high image quality of "the CBCT-scanner in detecting the residual fragments intraoperatively" (see Kingma; Page 555).
Regarding claim 6, Gururaj in view of Kingma teaches all claim limitations, as applied in claim 1, and Gururaj further teaches wherein the guidance imagery comprises a visual overlay indicative of a position of the interventional tool fused with an anatomical image representative of the anatomical area, the anatomical image being based on the CT image data acquired in the intra-operative image acquisition phase ("… the image acquisition unit may be configured to monitor real-time position of the at least one needle and the guide wire during the PCNL surgery …" [0025]; "… overlay the first set of images during the pre-operative CT scan data on real time second set of images of the patient being acquired during the PCNL, surgery to create augmented reality …" [0123]; the second set of images include the needle monitored by the image acquisition unit).
Regarding claim 7, Gururaj in view of Kingma teaches all claim limitations, as applied in claim 6, and Gururaj further teaches wherein the guidance imagery further includes one or more visual overlays providing navigation guidance for navigating insertion of the interventional tool along a pre-defined tool entry path from an incision point on the skin to a pre-defined entry point of the kidney ("… wherein the display unit may be configured to display augmented reality of any or a combination of the predetermined area of the patient, the optimal puncture path and the entry point for puncturing in the renal area, and the one or more organs present in the renal area, during the PCNL." [0020]).
Regarding claim 8, Gururaj in view of Kingma teaches all claim limitations, as applied in claim 7, and Gururaj further teaches wherein the method comprises an intervention planning phase comprising: obtaining an indication of a planned entry point of the kidney; obtaining an indication of a planned entry path through the body to the entry point of the kidney ("… along with an artificial intelligence (AI) engine for any or a combination of: identifying kidney and rib position of the patient, predicting an optimal puncture path for the surgery, and predicting an entry point on the marker patch for the PCNL surgery." [0102]); and
wherein the one or more visual overlays for providing navigation guidance are generated based on said obtained indications ("… wherein the display unit may be configured to display augmented reality of any or a combination of the predetermined area of the patient, the optimal puncture path and the entry point for puncturing in the renal area, and the one or more organs present in the renal area, during the PCNL." [0020]).
Regarding claim 9, Gururaj in view of Kingma teaches all claim limitations, as applied in claim 8, and Gururaj further teaches wherein the indication of the planned entry point of the kidney comprises an indication of a planned Calyx of the kidney through which kidney entry is to be achieved ("The image acquisition unit for the live image stream can be configured in the end effector ... The end effector can insert the needle into desired calyx and through the needle guide wire can be guided to secure the puncture site and perform the PCNL procedure." [0074]; the live image stream is the indication).
Regarding claim 10, Gururaj in view of Kingma teaches all claim limitations, as applied in claim 1, and Gururaj further teaches wherein the generating the guidance imagery comprises: generating synthetic image data by fusing the CT image data received during the at least one intra-operative image acquisition phase with pre-operative image data of the same anatomical area of the same patient retrieved from a datastore ("… the proposed system can use the first set of images gathered from the pre-operative CT scan and live image acquisition unit stream from the patient to acquire the second set of images in real time during the PCNL surgery and create augmented reality (AR) that can provide virtual insight in the patient's body ..." [0074]; "… overlay the first set of images during the pre-operative CT scan data on real time second set of images of the patient being acquired during the PCNL, surgery to create augmented reality …" [0123]).
Regarding claim 12, Gururaj in view of Kingma teaches all claim limitations, as applied in claim 1, and Gururaj further teaches wherein the processing unit further comprises a communication interface for wired or wireless connection to one or more of: a cone-beam CT imaging apparatus, a user interface device, and a tool tracking system ("This creates augmented reality that can be displayed on a display operatively connected to the computing unit of the proposed system." [0124]; wired or wireless communication interface is inherent component for any general computer; see also cited pertinent art Defreitas).
Regarding claim 13, Gururaj in view of Kingma teaches all claim limitations, as applied in claim 1, and Gururaj further teaches an ambulatory base station being moveable within an operating room ("… the base 106 can include an actuation mechanism to raise it up so that the RD 100 rests on wheels 108 …" [0089]; "Once the wheels rest on the floor (the RD in turn resting on the wheels), the RD can easily be moved away from the OT table." [0084]), and
Gururaj in view of Kingma further teaches a processing unit in accordance with claim 1 (see rejection of claim 1).
Regarding claim 14, Gururaj in view of Kingma teaches all claim limitations, as applied in claim 1, and Gururaj further teaches an X-ray image acquisition apparatus ("… the image acquisition unit may comprise any or a combination of ... at least one fluoroscopic imaging unit ..." [0028]); and
a tracking system for tracking a positioning of an interventional tool within the body of a patient ("Any or a combination of the image acquisition unit and sensors present in the RD can monitor/track the needle position as it is advanced during renal puncturing." [0074]).
In addition, Kingma further teaches cone beam computed tomography (CT) is suitable for intra-operative image acquisition ("CBCT allows for intraoperative high-resolution cross-sectional and three-dimensional imaging." Page 552).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the image acquisition and corresponding procedure as taught by Gururaj with CBCT in kidney procedure as taught by Kingma. It is "for the purpose of removing additional stone fragments" to utilize the high image quality of "the CBCT-scanner in detecting the residual fragments intraoperatively" (see Kingma; Page 555).
Regarding claim 15, Gururaj teaches a computer-implemented method ("… the computing unit comprising one or more processors configured to execute one or more instructions stored in a memory of the computing unit …" [0019]) for interventional support during a renal interventional procedure for kidney stone removal ("… a system for renal puncturing assistance in a percutaneous nephrolithotomy (PCNL) surgery ..." [0019]; by definition, PCNL is a minimally invasive surgical procedure to remove large kidney stones) comprising:
at least one intra-operative image acquisition phase ("… an image acquisition unit configured to collect a second set of images of the predetermined area of the patient in real-time during the PCNL, surgery …" [0019]), comprising:
receiving X-ray image data ("… the image acquisition unit may comprise any or a combination of ... at least one fluoroscopic imaging unit ..." [0028]) of an anatomical area which includes at least a portion of a kidney of a subject ("... with real time intra-operative images acquired using image acquisition unit in the end effector, and the AR engine can be used along with an artificial intelligence (AI) engine for any or a combination of: identifying kidney and rib position of the patient" [0102]);
an interventional image guidance phase ("… the image acquisition unit may be configured to monitor real-time position of the at least one needle and the guide wire during the PCNL surgery …" [0025]), comprising:
receiving real-time tool tracking data indicative of a positioning of an interventional tool for use in the interventional procedure ("… the image acquisition unit may be configured to monitor real-time position of the at least one needle and the guide wire during the PCNL surgery …" [0025]),
generating real-time guidance imagery based on the CT image data ("… and wherein the computing unit may be configured to provide augmented reality of the positions of the at least one needle and the guide wire to the user during the PCNL surgery." [0025]; "The computing unit 508 can receive positional data pertaining to the needle/guide wire by means of the image acquisition unit 520 ..." [0123]), and further based on the tracking data, the guidance imagery visualizing a position of the interventional tool relative to the anatomical area imaged in the CT image data ("… the image acquisition unit may be configured to monitor real-time position of the at least one needle and the guide wire during the PCNL surgery …" [0025]; "… overlay the first set of images during the pre-operative CT scan data on real time second set of images of the patient being acquired during the PCNL, surgery to create augmented reality …" [0123]),
communicating with a user interface device to display the generated guidance imagery in real time on a display unit of the user-interface device ("… to provide augmented reality of the positions of the at least one needle and the guide wire to the user during the PCNL surgery." [0025]; "The display unit can be configured to display augmented reality …" [0056]).
Although Gururaj does not explicitly teach the image acquisition unit for intra-operative imaging is a CT imaging unit, the taught image acquisition unit is X-ray based fluoroscopy system which can be used to perform tomographic imaging. Gururaj also fails to explicitly teach a quality assurance check phase, following the interventional image guidance phase, comprising: communicating with a CT imaging apparatus to acquire further CT image data of said anatomical area using a CT imaging apparatus, for use in visualizing any residual stones or stone fragments, for use thereby in determining whether complete stone removal has been achieved, wherein the further CT image data is cone beam CT image data, and communicating with the user-interface device to display the further CT image data on the display unit of the user interface.
However, in the same field of endeavor, Kingma teaches computed tomography (CT) is suitable for intra-operative image acquisition ("CBCT allows for intraoperative high-resolution cross-sectional and three-dimensional imaging." Page 552).
Kingma further teaches a quality assurance check phase, following the interventional image guidance phase ("A CBCT-scan was made at the end of the procedure, where the urologist thought to have obtained a stone-free status by means of nephroscopy …" Page 552), comprising:
communicating with a CT imaging apparatus to acquire further CT image data of said anatomical area using a CT imaging apparatus, for use in visualizing any residual stones or stone fragments, for use thereby in determining whether complete stone removal has been achieved ("A CBCT-scan was made at the end of the procedure … any residual fragments imaged on the CBCT-scan could then still be attempted to be extracted in a continued procedure, after re-introducing the sheath and nephroscope … Two definitions of a stone-free status were used; fully stone-free with no residual fragments on follow-up CT and as is common in literature, a definition of stone-free with residual fragments ≤ 4 mm in maximum diameter." Page 552), wherein the further CT image data is cone beam CT image data ("An image modality that could facilitate the intraoperative assessment of the stone-free status is cone beam computed tomography (CBCT)." Page 552; "A CBCT-scan was made at the end of the procedure …" Page 552), and
communicating with the user-interface device to display the further CT image data on the display unit of the user interface (see Fig.1 and Fig.2).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the image acquisition and corresponding procedure as taught by Gururaj with CBCT in kidney procedure as taught by Kingma. It is "for the purpose of removing additional stone fragments" to utilize the high image quality of "the CBCT-scanner in detecting the residual fragments intraoperatively" (see Kingma; Page 555).
Regarding claim 16, Gururaj further teaches a computer program product comprising computer program code configured, when run on a processor, to cause the processor to perform ("… the computing unit comprising one or more processors configured to execute one or more instructions stored in a memory of the computing unit …" [0019]) the method of claim 15 (see rejection of claim 15).
Regarding claim 17, Gururaj in view of Kingma teaches all claim limitations, as applied in claim 7, and Gururaj further teaches wherein the one or more visual overlays providing navigation guidance provide a visual indication of a target location of the incision point ("The first positional data can be matched with the second positional data derived from the markers on the patient during real time intra-operative image acquisition while creating an operational window for the PCNL surgery … and such inputs can be displayed on the display unit 514 controlled by the computing unit 508 to help the user position the marker patch 504 with respect to the patient as appropriate." [0122]) and an indication of a target angle of insertion for the tool ("The display unit can be configured to display augmented reality of any or a combination of the predetermined area of the patient, the optimal puncture path and the entry point for puncturing in the renal area ..." [0056]; the path includes angle requirement).
Claim 11 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gururaj in view of Kingma, as applied in claim 1 and 12 respectively, and further in view of Kumar et al. (US 2014/0073907 A1; published on 03/13/2014) (hereinafter "Kumar").
Regarding claim 11, Gururaj in view of Kingma teaches all claim limitations, as applied in claim 1, except wherein the image guidance phase further comprises receiving supplementary image data comprising one or more of: real time endoscopic imaging data from an endoscopic imaging system; real-time ultrasound imaging data from an ultrasound imaging system; real-time fluoroscopic imaging data from a cone-beam CT imaging apparatus, and wherein the image guidance phase comprises: communicating with the user interface to simultaneously display the guidance imagery and the supplementary image data.
However, in the same field of endeavor, Kumar teaches wherein the image guidance phase further comprises receiving supplementary image data comprising real-time ultrasound imaging data from an ultrasound imaging system ("In one embodiment, the pre-operative imaging comprises use of the same imaging modality as used intra-operatively, generally along with an additional imaging technology. Thus, an ultrasound volume of the patient's prostate may be obtained … and a registered image of the 3D TRUS volume is generated in the same frame of reference (FOR) as the MRI or CAT scan image." [0050]), and
wherein the image guidance phase comprises: communicating with the user interface to simultaneously display the guidance imagery and the supplementary image data ("Thus, during a later real-time TRUS guided diagnostic or therapeutic procedure, a fully fused volume model is available … so features from the real-time scan can be aligned with those of the prior imaging procedure. The fused image from the MRI (or CAT) scan provides better localization of the suspect pathological tissue, and therefore guidance of the diagnostic biopsy or therapeutic intervention." [0050]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the image acquisition and corresponding procedure as taught by Gururaj with additional imaging modality during procedure as taught by Kumar. Doing so would make it helpful for image guided procedure "by compensating for differences in the patient's anatomy between acquisition of the non-real time image and the real time procedure, using, for example, general anatomical information, landmarks common to both images, and tissue and procedure models" (see Kumar; [0020]).
Regarding claim 18, Gururaj in view of Kingma teaches all claim limitations, as applied in claim 12, except wherein the processing unit further comprises a communication interface for wired or wireless connection to at least one of an ultrasound imaging system and an endoscopic imaging system.
However, in the same field of endeavor, Kumar teaches wherein the processing unit further comprises a communication interface for wired or wireless connection to an ultrasound imaging system ("… and a computer programmed with suitable software may be connected to the ultrasound machine …" [0105]; wired or wireless communication interface is inherent component for any general computer; see also cited pertinent art Defreitas).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the image acquisition and corresponding procedure as taught by Gururaj with additional imaging modality during procedure as taught by Kumar. Doing so would make it helpful for image guided procedure "by compensating for differences in the patient's anatomy between acquisition of the non-real time image and the real time procedure, using, for example, general anatomical information, landmarks common to both images, and tissue and procedure models" (see Kumar; [0020]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Defreitas et al. (US 2020/0352543 A1; published on 11/12/2020) teaches a multi-modality imaging system, wherein the CT imaging device and ultrasound imaging device are connected to a computer system with wired and/or wireless communication network.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797