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 Arguments
Applicant's arguments below filed 3/4/2026 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection.
The Applicant asserts on pages 11-12 of the Remarks:
“1. Hawkes in view of Hochmitz fails to teach a robotic manipulator configured to support and move the surgical instrument, as claimed.
As effectively conceded in the Office Action (page 13; claim 8), neither Hawkes nor Hochmitz teach or even suggest a robotic manipulator configured to support and move the surgical instrument. Therefore, the independent claims as currently presented overcome the existing rejection of Hawkes in view of Hochmitz.
The Office Action relies on Bowling to allegedly teach this feature. The Office Action alleges that it would be obvious to modify the system of Hawkes to incorporate Bowling's manipulator. Specifically, it is alleged one would have motivation to combine because "in an orthopedic joint replacement procedure, the practitioner may want the instrument, a cutting tool, to move in a programmed path in order to precisely shape the bone to which the instrument is applied. This precise bone shaping facilitates the precise fitting of the implant to the face of the bone exposed by the cutting tool."”
In response the examiner respectfully asserts that the claim now requires both the surgical instrument and the imaging device being supported and moved by a robotic manipulator therefore a new grounds of rejection was made to teach a robotic manipulator configured to support and move the surgical instrument and the Bowling reference is no longer relied upon in the current office action.
The Applicant asserts on page 12 of the Remarks:
“2. Hawkes in view of Hochmitz fails to teach a robotic manipulator configured to support and move the imaging device, as claimed.
As effectively conceded in the Office Action (page 14; claim 10), neither Hawkes nor Hochmitz teach or even suggest a robotic manipulator configured to support and move the imaging device. Therefore, for this additional reason, the independent claims as currently presented overcome the existing rejection of Hawkes in view of Hochmitz.
The Office Action relies on Boctor to allegedly teach this feature. The Office Action alleges that it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hawkes to incorporate the robotic manipulation the ultrasound probe of Boctor to achieve the same results. One would have motivation to combine because "advantages of having a robot in the system can include precise alignment and ease of operation." (Boctor [0103]). We will address this motivation below.”
In response the examiner respectfully asserts that the claim now requires both the surgical instrument and the imaging device being supported and moved by a robotic manipulator therefore a new grounds of rejection was made to teach a robotic manipulator configured to support and move the imaging device and the Boctor reference is no longer relied upon in the current office action..
The Applicant asserts on pages 13-14 of the Remarks:
“Regarding temporal calibration, it is alleged that "it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method of Hawkes to incorporate the temporal calibration of Hochmitz to achieve the same results. One would have motivation to combine because "the ultrasound images and position measurements should be correlated with one another, so as to correctly determine the position (location and orientation) of the probe at the time each ultrasound image was acquired."
One skilled in the art could not modify Hawkes in view of Hochmitz without destroying the intended purpose of Hawkes.
Hochmitz teaches temporal calibration between the ultrasound images and position measurements, wherein the measurements are generated by a position sensor integrated in the ultrasound imager itself. This integrated position sensor configuration lends itself to a specific physical calibration solution in Hochmitz wherein the probe/position sensor unit is moved through a wheel motion assembly that concurrently acquires US images and positions measurements. To modify Hawkes to incorporate the temporal calibration technique of Hochmitz would entail modifying Hawkes so that its position sensor is integrated in the ultrasound imager itself - after all - this is the only way that the calibration solution in Hochmitz would work. A broad concept such as "temporal calibration" cannot reasonably be extracted from Hochmitz without context of the system in which this calibration is performed. Yet, one skilled in the art would not modify Hawkes to integrate the position sensor on Hawkes' ultrasound imager itself because doing so would destroy the system and intended purpose of Hawkes. Namely, Hawkes requires an optical tracking system that is remote from the imaging probe and tracks markers (3) attached to the probe.
Moreover, Hawkes' imaging device is swept across the skin of the patient (externally). However, Hochmitz's ultrasound imaging system is inserted (internally) into a chamber of the heart through a vein or artery. These two configurations are incompatible, particularly considering that the reason the position sensor is integrated into Hochmitz is to enable internal tracking of the imaging device when it is internally passing through the heart region. There is no reasonable way to combine these teachings.”
In response the examiner respectfully asserts that one with ordinary skill in the art would recognize the position sensor unit of Hochmitz is moved through a wheel motion to acquire images at known positions and to mark the images at those locations. One with ordinary skill in the art would also recognize this can be done using the markers on the outside of the probe of Hawkes and the point-target phantom of Hawkes. The point-target phantom would provide marked images of point-targets at known positions. Therefore in light of the teachings of Hawkes and Hochmitz the timing of the output of the marked image can be determined as well as the timing of the position measurement whose coordinates match the coordinates of marked image to determine the lag and make a calibration based on the lag. Therefore the argument is found to be not persuasive.
The Applicant asserts on page 16 of the Remarks:
“The independent claims recite: wherein the second modality of imaging is associated with a surgical plan defining a target volume to be removed from the bone and a predefined boundary for the surgical instrument; and the one or more controllers are configured to: utilize the registered ultrasound imaging to facilitate control the robotic manipulator to move the surgical instrument relative to the bone to remove the target volume from the bone while utilizing the predefined boundary to constrain movement of the surgical instrument.
Firstly, we respectfully assert that no combination of the cited references teaches to utilize the registered ultrasound imaging to facilitate control of the robotic manipulator to move the surgical instrument, as claimed. We assert the claims are patentable for this additional reason.
Moreover, even if we assume Hawkes/Hochmitz/Bowling/Boctor can be combined, which we maintain they cannot, the combination will still need to rely on Quaid. Yet, modifying Hawkes/Hochmitz/Bowling/Boctor in view of Quaid would entail bringing in a haptic control scheme from yet a third robotic system. A concept such as a "haptic object" cannot be fairly extracted from Quaid without context of the robotic system in which it is embodied. Introducing Quaid's third robotic system would require substantial modification to the Hawkes/Hochmitz/Bowling/Boctor system. Moreover, the robotic system of Quaid is used in conjunction with a navigation system that remotely tracks the robot and the anatomy. This contradicts inclusion of Hochmitz requiring the position sensor to be integrated to the imaging probe.”
In response the examiner respectfully asserts that Hawkes discloses a registration between a registration between the ultrasound images and the model of the body part which is formed using pre-operative imaging. Hawkes also teaches utilizing the registered ultrasound imaging to facilitate control of the surgical instrument. Additionally Quiad discloses utilizing the registered imaging data to facilitate control the robotic manipulator to move the surgical instrument. Therefore one with ordinary skill in the art would find it obvious in view of Hawkes and Quiad to utilize the registered ultrasound imaging to facilitate control the robotic manipulator to move the surgical instrument.
Bowling and Boctor are no longer relied upon in the current rejection.
As recited above one with ordinary skill in the art would recognize that the position markers on the ultrasound probe of Hawks along with the point-target phantom would provide the marked images at known locations similar to the calibration apparatus of Hochmitz. Therefore the arguments are not persuasive.
Claim Objections
Claims 1 and 14 are objected to because of the following informalities: The last paragraph of claims 1 and 14 recites “facilitate control the robotic manipulator”. However this should be read as “facilitate control of the robotic manipulator”. 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.
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.
Claims 1, 6-14, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hawkes (WO 2006092602) and further in view of Hochmitz (US 20080178654), Ramadorai (US 20190290374), and Quiad (US 20060142657).
Regarding claims 1 and 14, Hawkes discloses a surgical system and method (pg. 6 lines 27-28 – “the computer aided surgery (CAS) system”, Fig. 1 shows a method), comprising:
a surgical instrument configured to remove material from a bone (pg. 7 lines 19-21 – “the registered patient model can be used to navigate various instruments, implants and other entities during a navigated surgical procedure”, pg. 4 lines 21-25 – “Examples of surgical procedures to which the technique of the present invention is applicable include orthopaedic joint procedures (for example replacement of hip, knee, shoulder, ankle and elbow joints), peri-acetabular osteotomy, tibial osteotomy, distal radius osteotomy, anterior cruciate ligament reconstruction, osteoid osteoma excision, bone tumour resection”);
an imaging device configured to generate ultrasound imaging of the bone by propagation of ultrasound waves along a plurality of scanlines through the bone (pg. 3 lines 14-15 – “the direction of propagation of the ultrasound waves”, pg. 9 lines 20-22 – “a number of images are formed by electronically steering the US beam through several preset angles”, pg. 10 lines 8-9 – “US images of the patient's femur 20 are captured 42 using the ultrasound probe”);
a surgical navigation system defining a tracking coordinate system and comprising a localizer configured to detect a tracker or a marker coupled to the bone (pg. 7 line 18 – “the tracking system of the CAS system”, pg. 11 lines 24-25 – “the coordinate system, or reference frame, of the tracking system”, pg. 7 lines 10-13 – “a marker bearing a plurality of infrared LEDs or reflective spheres trackable by a tracking system part of the CAS system is attached to the patient’s body part to allow the position of the patient’s body part in the reference frame of the tracking system to be dynamically determined”, pg. 6 lines 25-26 – “the patient's body part, in this instance the femur”); and
one or more controllers coupled to the imaging device […] and the surgical navigation system (pg. 16 lines 3-9 – “a typical computer system that, when appropriately configured or designed, can serve as the data processing apparatus or computer of the CAS system according to the invention. The data processing apparatus or computer 500 includes any number of processors 502 (also referred to as central processing units, or CPUs)… CPU 502 may be of various types including microcontrollers”) and configured to:
detect, using the localizer, a pose of the bone in the tracking coordinate system (pg. 7 lines 10-13 – “a marker bearing a plurality of infrared LEDs or reflective spheres trackable by a tracking system part of the CAS system is attached to the patient’s body part to allow the position of the patient’s body part in the reference frame of the tracking system to be dynamically determined”, pg. 6 lines 25-26 – “the patient's body part, in this instance the femur”, pg. 11 lines 23-24 – “specify the 3D position and orientation of the DRO”);
acquire the ultrasound imaging of the bone from the imaging device (pg. 10 lines 8-9 – “US images of the patient's femur 20 are captured 42 using the ultrasound probe”);
automatically register the ultrasound imaging to a second modality imaging of the bone (Fig. 1 step 106, pg. 7 lines 16-18 – “the US scan data is processed and made available to the computer part of the CAS system. Then at step 106 the registration method of the invention is used to register the patient model in the reference frame of the tracking system of the CAS system”, pg. 15 lines 3-4 – “an automatic, image-intensity-based method for bone registration using US data”); and
utilize the registered ultrasound imaging to facilitate control […] of the surgical instrument relative to the bone (pg. 7 lines 19-22 – “once the model of the patient's body part has been registered, the registered patient model can be used to navigate various instruments, implants and other entities during a navigated surgical procedure 108. The navigated surgical procedure may include various general operations such as planning the surgical procedure or image guided surgical steps”).
Conversely Hawkes does not teach a robotic manipulator configured to support and move the surgical instrument and the imaging device;
one or more controllers coupled to the imaging device, the robotic manipulator, and the surgical navigation system
temporally calibrate the ultrasound imaging with respect to the tracking coordinate system by computing a temporal lag for the ultrasound imaging;
wherein the second modality of imaging is associated with a surgical plan defining a target volume to be removed from the bone and a predefined boundary for the surgical instrument; and
utilize the registered ultrasound imaging to facilitate control the robotic manipulator to move the surgical instrument relative to the bone to remove the target volume from the bone while utilizing the predefined boundary to constrain movement of the surgical instrument.
However Hochmitz discloses temporally calibrate the ultrasound imaging with respect to the tracking coordinate system by computing a temporal lag for the ultrasound imaging ([0032] – “The calibration processor calculates the time offset between the ultrasound images and the corresponding position measurements. The calculated time offset value is stored and used to correlate between the ultrasound images and the position measurements”);
Hochmitz is an analogous art considering it is in the field of performing ultrasound calibration.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method of Hawkes to incorporate the temporal calibration of Hochmitz to achieve the same results. One would have motivation to combine because “the ultrasound images and position measurements should be correlated with one another, so as to correctly determine the position (location and orientation) of the probe at the time each ultrasound image was acquired. Embodiments of the present invention provide methods and systems for correlating the sequences of ultrasound images and position measurements” (Hochmitz [0030] and [0031]).
Conversely Hawkes and Hochmitz do not teach a robotic manipulator configured to support and move the surgical instrument and the imaging device;
one or more controllers coupled to the imaging device, the robotic manipulator, and the surgical navigation system;
wherein the second modality of imaging is associated with a surgical plan defining a target volume to be removed from the bone and a predefined boundary for the surgical instrument; and
utilize the registered ultrasound imaging to facilitate control the robotic manipulator to move the surgical instrument relative to the bone to remove the target volume from the bone while utilizing the predefined boundary to constrain movement of the surgical instrument.
However Ramadorai discloses a robotic manipulator configured to support and move the surgical instrument and the imaging device ([0040] – “Although two robotic manipulators 12 are depicted, the surgical system 10 may include more than two robotic manipulators 12… one or more of the robotic manipulators 12 includes an imaging device 66 positioned over the surgical site “S”, in the surgical site “S” (not shown) or the like. The imaging devices 66 may capture visual images, infra-red images, ultrasound images”);
one or more controllers coupled to the imaging device, the robotic manipulator, and the surgical navigation system (Figs. 2 and 3, [0053] – “The controller 220 is configured to communicate with the tower 230 to thereby provide instructions for operation, in response to input received from one of the consoles 240”, [0045] – “The controller 30 can include a plurality of inputs and outputs for interfacing with the components of the console 40 and/or the robotic arm 12”, as seen in Fig. 2 the tower includes the manipulators and the imaging device);
Ramadorai is an analogous art considering it is in the field of performing a surgical procedure on bone while performing an imaging procedure.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method of Hawkes to incorporate the robotic manipulator configured to support and move the surgical instrument and the imaging device of Ramadorai to achieve the same results. One would have motivation to combine because it would allow one to precisely position both the surgical instrument and the imaging device while avoiding the decrease in hand-eye coordination caused by using a non-dominant hand or avoiding the need for a second operator.
As cited above Hawkes discloses registering the ultrasound imaging to a second modality imaging. Conversely Hawkes, Hochmitz, and Ramadorai do not teach wherein the second modality of imaging is associated with a surgical plan defining a target volume to be removed from the bone and a predefined boundary for the surgical instrument; and
utilize the registered […] imaging to facilitate control the robotic manipulator to move the surgical instrument relative to the bone to remove the target volume from the bone while utilizing the predefined boundary to constrain movement of the surgical instrument.
However Quid discloses wherein the second modality of imaging is associated with a surgical plan defining a target volume to be removed from the bone and a predefined boundary for the surgical instrument ([0108] – “Guidance from the haptic device 30 coupled with computer aided surgery (CAS) enables a surgeon to actively and accurately control surgical actions (e.g., bone cutting)…determine the control parameters based on data representative of a patient's anatomy (e.g., preoperative CT image data, ultrasound data)…in operation, as a surgeon manipulates the haptic device 30 to move the tool 50, virtual pathways may be used to guide the tool 50 to specific targets, virtual boundaries may be used”); and
utilize the registered […] imaging to facilitate control the robotic manipulator to move the surgical instrument relative to the bone to remove the target volume from the bone while utilizing the predefined boundary to constrain movement of the surgical instrument ([0099] – “image data (e.g., two- or three-dimensional image data sets obtained using any suitable imaging modality, such as…computed tomography (CT)…ultrasound”, [0100] – “registering a patient and an image data set to a coordinate frame of the tracking system 40”, [0109] – “When the tool is in proximity to a virtual boundary in registration with the patient, however, the surgical system 10 controls the haptic device 30 to provide haptic guidance that tends to constrain the surgeon from penetrating the virtual boundary with the tool”, [0156] – “the haptic object can be used to guide the user in removing the diseased bone while sparing healthy surrounding bone”).
Quaid is an analogous art considering it is in the field of surgical tracking and navigation.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method of Hawkes to incorporate the boundary for navigated guidance of Quaid to achieve the same results. One would have motivation to combine because “the haptic object can be used to guide the user in removing the diseased bone while sparing healthy surrounding bone” (Quaid [0156]).
Regarding claims 6, Hawkes, Hochmitz, Ramadorai, and Quaid disclose all the elements of the claimed invention as cited in claim 1.
Conversely Hawkes does not teach wherein the one or more controllers are configured to facilitate control of the robotic manipulator in a semi-autonomous mode to move the surgical instrument relative to the bone.
However Quaid discloses wherein the one or more controllers are configured to facilitate control of the robotic manipulator in a semi-autonomous mode to move the surgical instrument relative to the bone ([0123] – “the haptic device 30 is that the haptic device 30 is not intended to move autonomously on its own…the surgeon maintains control of the cutting operation”, [0109] – “When the tool is in proximity to a virtual boundary in registration with the patient, however, the surgical system 10 controls the haptic device 30 to provide haptic guidance that tends to constrain the surgeon from penetrating the virtual boundary with the tool”)).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hawkes to incorporate the semi-autonomous of a robotic manipulator of Quaid to achieve the same results. One would have motivation to combine because it allows the surgeon to have control over the procedure while also preventing movements that may cause unwanted damage to the tissue.
Regarding claim 7, Hawkes, Hochmitz, Ramadorai, and Quaid disclose all the elements of the claimed invention as cited in claim 1.
As cited above Hawkes discloses registering the ultrasound imaging to a second modality imaging. Conversely Hawkes does not teach wherein: the surgical plan further comprises a predefined path for the surgical instrument; and the one or more controllers further utilize the registered […] imaging to facilitate control the robotic manipulator to move the surgical instrument along the predefined path relative to the bone to remove the target volume from the bone.
However Quaid discloses wherein: the surgical plan further comprises a predefined path for the surgical instrument ([0108] – “Thus, in operation, as a surgeon manipulates the haptic device 30 to move the tool 50, virtual pathways may be used to guide the tool 50 to specific targets”); and the one or more controllers further utilize the registered […] imaging to facilitate control the robotic manipulator to move the surgical instrument along the predefined path relative to the bone to remove the target volume from the bone ([0108] – “control surgical actions (e.g., bone cutting)…determine the control parameters based on data representative of a patient's anatomy (e.g., preoperative CT image data, ultrasound data”, [0100] – “registering a patient and an image data set to a coordinate frame of the tracking system 40”, [0184] – “In the approach mode, the virtual object is activated so that movement of a portion of the haptic device 30 (e.g., the tool 50) is constrained along the pathway defined by the haptic object 310”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hawkes to incorporate the semi-autonomous of a robotic manipulator of Quaid to achieve the same results. One would have motivation to combine because it provides the surgeon with guidance for preferred movements to correctly and safely perform the procedure.
Regarding claim 8, Hawkes, Hochmitz, Ramadorai, and Quaid disclose all the elements of the claimed invention as cited in claim 1.
Conversely Hawkes does not teach wherein the robotic manipulator comprises a plurality of robotic arms.
However Ramadorai teaches wherein the robotic manipulator comprises a plurality of robotic arms (Fig. 1, as seen in Fig. 1 there are multiple robotic arms).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hawkes to incorporate the robotic manipulator comprises a plurality of robotic arms of Ramadorai to achieve the same results. One would have motivation to combine because it would allow one to precisely position both the surgical instrument and the imaging device while avoiding the decrease in hand-eye coordination caused by using a non-dominant hand or avoiding the need for a second operator.
Regarding claim 9, Hawkes, Hochmitz, Ramadorai, and Quaid disclose all the elements of the claimed invention as cited in claim 1.
Conversely Hawkes does not teach wherein the predefined boundary defines a surface that delineates the target volume from regions of the bone that should remain after a procedure; and the one or more controllers constrain movement of the surgical instrument by being configured to prevent a working end of the surgical instrument from extending beyond the surface of the predefined boundary.
However Quaid discloses wherein the predefined boundary defines a surface that delineates the target volume from regions of the bone that should remain after a procedure; and the one or more controllers constrain movement of the surgical instrument by being configured to prevent a working end of the surgical instrument from extending beyond the surface of the predefined boundary ([0108] – “control surgical actions (e.g., bone cutting)…determine the control parameters based on data representative of a patient's anatomy (e.g., preoperative CT image data, ultrasound data”, [0100] – “registering a patient and an image data set to a coordinate frame of the tracking system 40”, [0184] – “In the approach mode, the virtual object is activated so that movement of a portion of the haptic device 30 (e.g., the tool 50) is constrained along the pathway defined by the haptic object 310”, [0156] – “the haptic object may define a virtual cutting boundary that encompasses only diseased bone. Thus, the haptic object can be used to guide the user in removing the diseased bone while sparing healthy surrounding bone”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hawkes to incorporate constraining movement of the surgical instrument to prevent the surgical instrument from extending past the predefined boundary of Quaid to achieve the same results. One would have motivation to combine because One would have motivation to combine because “the haptic object can be used to guide the user in removing the diseased bone while sparing healthy surrounding bone” (Quaid [0156]).
Regarding claims 10 and 20, Hawkes, Hochmitz, Ramadorai, and Quaid disclose all the elements of the claimed invention as cited in claims 1 and 14.
Conversely Hawkes does not teach wherein: the predefined boundary defines a predefined trajectory for the surgical instrument; and the one or more controllers constrain movement of the surgical instrument by being configured to constrain movement of a working end of the surgical instrument to the predefined trajectory.
However Quaid discloses wherein: the predefined boundary defines a predefined trajectory for the surgical instrument; and the one or more controllers constrain movement of the surgical instrument by being configured to constrain movement of a working end of the surgical instrument to the predefined trajectory ([0189] – “The navigation pane 600 may also include, for example, a representation of a current position of the tool 50, a desired trajectory of the tool 50”, [0109] – “When the tool is in proximity to a virtual boundary in registration with the patient, however, the surgical system 10 controls the haptic device 30 to provide haptic guidance that tends to constrain the surgeon from penetrating the virtual boundary with the tool”, one with ordinary skill in the art would find it obvious to constrain a trajectory of the tool such as a saw to constrain the surgeon from penetrating the virtual boundary with the tool).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Hawkes to incorporate constraining movement of the surgical instrument to prevent the surgical instrument from extending past the predefined boundary of Quaid to achieve the same results. One would have motivation to combine because One would have motivation to combine because “the haptic object can be used to guide the user in removing the diseased bone while sparing healthy surrounding bone” (Quaid [0156]).
Regarding claim 11, Hawkes, Hochmitz, Ramadorai, and Quaid disclose all the elements of the claimed invention as cited in claim 1.
Hawkes further discloses wherein the localizer is further configured to detect a tracker or a marker coupled to the imaging device (pg. 8 lines 9-10 – “The scan-probe can be tracked by a suitable trackable marker 3 such as an array of LEDs, as shown in Figs. 2 and 3”).
Regarding claims 12, Hawkes, Hochmitz, Ramadorai, and Quaid disclose all the elements of the claimed invention as cited in claim 1.
Conversely Hawkes does not teach comprising a display device configured to present the registered ultrasound imaging wherein the display device presents representations of the surgical instrument and the bone and relative real-world motion between the surgical instrument and the bone.
However Quaid discloses comprising a display device ([0091] – “a display device 23”) configured to present the registered ultrasound imaging wherein the display device presents representations of the surgical instrument and the bone and relative real-world motion between the surgical instrument and the bone ([0099] – “image data (e.g., two- or three-dimensional image data sets obtained using any suitable imaging modality, such as…ultrasound”, [0100] – “registering a patient and an image data set to a coordinate frame of the tracking system 40”, [0188] – “the navigation pane 600 may create and display a representation of the anatomy (such as an image or representation of a bone) and a representation 616 of the surgical tool 50…the surgical system 10 can update the representation of the bone and the representation 616 of the tool 50 as the bone and the tool 50 move”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method of Hawkes to incorporate the display of Quaid to achieve the same results. One would have motivation to combine because it provides real time visual guidance for the surgical procedure.
Regarding claim 13, Hawkes, Hochmitz, Ramadorai, and Quaid disclose all the elements of the claimed invention as cited in claim 1.
Hawkes further discloses wherein: the ultrasound imaging is generated intraoperatively (pg. 7 lines 15-16 – “an ultrasound ("US") image of the patient's body part is taken intra- operatively”); and
the second modality imaging is a pre-operatively computed tomography (CT) or magnetic resonance imaging (MRI) scan (pg. 6 lines 25-26 – “In a pre-operative initial step 102, images of the patient's body part, in this instance the femur, are captured by carrying out a CT scan of the femur”).
Regarding claim 19, Hawkes, Hochmitz, Ramadorai, and Quaid disclose all the elements of the claimed invention as cited in claim 14.
Conversely Hawkes does not teach comprising the one or more controllers facilitating control of the robotic manipulator in a semi-autonomous mode to move the surgical instrument relative to the bone along a predefined path defined by the surgical plan.
However Quaid discloses comprising the one or more controllers facilitating control of the robotic manipulator in a semi-autonomous mode ([0123] – “the haptic device 30 is that the haptic device 30 is not intended to move autonomously on its own…the surgeon maintains control of the cutting operation”, [0109] – “When the tool is in proximity to a virtual boundary in registration with the patient, however, the surgical system 10 controls the haptic device 30 to provide haptic guidance that tends to constrain the surgeon from penetrating the virtual boundary with the tool”) to move the surgical instrument relative to the bone along a predefined path defined by the surgical plan ([0184] – “In the approach mode, the virtual object is activated so that movement of a portion of the haptic device 30 (e.g., the tool 50) is constrained along the pathway defined by the haptic object 310”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method of Hawkes to incorporate the semi-autonomous of a robotic manipulator of Quaid to achieve the same results. One would have motivation to combine because it allows the surgeon to have control over the procedure while also preventing movements outside of a pathway or across a boundary and therefore allows one to safely perform the procedure.
Claims 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hawkes (WO 2006092602), Hochmitz (US 20080178654), Ramadorai (US 20190290374), and Quiad (US 20060142657) as applied to claims 1 and 14 above, and further in view of Brendel (EP 1312309A1).
Regarding claims 2 and 15, Hawkes, Hochmitz, Ramadorai, and Quaid disclose all the elements of the claimed invention as cited in claims 1 and 14.
Hawkes further discloses wherein the one or more controllers […] calibrate the ultrasound imaging with respect to the tracking coordinate system by further being configured to create a point cloud of a surface of the bone (pg. 2 lines 9-11 – “The technique of the invention involves including calibration parameters as free parameters in the numerical optimization that forms the basis of a point to surface matching algorithm”);
However Hawkes does not teach temporally calibrate the ultrasound imaging with respect to the tracking coordinate system, calculate a set of projection values of the point cloud to a 3D vector that is oriented parallel to an average direction of the plurality of scanlines; and calculate the temporal lag for the ultrasound imaging by minimization of a variance of the set of projection values.
However Hochmitz discloses temporally calibrate the ultrasound imaging with respect to the tracking coordinate system, and calculate the temporal lag for the ultrasound imaging by minimization of a variance of the set of projection values ([0066] – “temporally calibrate the ultrasound imaging with respect to the tracking coordinate system, calculate a set of projection values of the point cloud to a 3D vector that is oriented parallel to an average direction of the plurality of scanlines; and calculate the temporal lag for the ultrasound imaging by minimization of a variance of the set of projection values”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method of Hawkes to incorporate the temporal calibration of Hochmitz to achieve the same results. One would have motivation to combine because “the ultrasound images and position measurements should be correlated with one another, so as to correctly determine the position (location and orientation) of the probe at the time each ultrasound image was acquired. Embodiments of the present invention provide methods and systems for correlating the sequences of ultrasound images and position measurements” (Hochmitz [0030] and [0031]).
Conversely Hawkes and Hochmitz do not teach calculate a set of projection values of the point cloud to a 3D vector that is oriented parallel to an average direction of the plurality of scanlines,
However Brendel discloses calculate a set of projection values of the point cloud to a 3D vector that is oriented parallel to an average direction of the plurality of scanlines ([0053] – “Transformations between the ultrasound image data and the reference image data can be determined particularly reliably using weight factors if these are calculated from the normal vectors at points on the surface and the corresponding vectors of the propagation direction of the ultrasound. Scalar products between these vectors are particularly suitable for this purpose”, [0094] – “three-dimensional ultrasound imaging”),
Brendel is an analogous art considering it is in the field of ultrasound imaging of a bone.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method of Hawkes to incorporate the vector in the propagation direction of Brendel to achieve the same results. One would have motivation to combine because it “brings the identified image areas into the best possible agreement” (Brendel [0026]).
Claims 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hawkes (WO 2006092602), Hochmitz (US 20080178654), Ramadorai (US 20190290374), and Quiad (US 20060142657) as applied to claims 1 and 14 above, and further in view of Wilson (WO 2016168194).
Regarding claims 3 and 16, Hawkes, Hochmitz, Ramadorai, and Quaid disclose all the elements of the claimed invention as cited in claims 1 and 14.
Conversely Hawkes does not teach wherein the one or more controllers are further segment the ultrasound imaging by being configured to: generate a probability map with a convolutional neural network; and extract a surface of the bone from the probability map for each of the plurality of scanlines.
However Wilson discloses wherein the one or more controllers are further segment the ultrasound imaging by being configured to: generate a probability map with a convolutional neural network; and extract a surface of the bone from the probability map for each of the plurality of scanlines (Para [0053] – “The rib edge map B1 displays the probability of rib edge occurrence at a pixel within the image. The edge map B1 may be calculated using simple edge filters or using a convolutional neural network trained from rib-annotated images with a supervised learning process”, [0054] – “binary segmentation rib mask”).
Wilson is an analogous art considering it is in the field of segmentation of a bone surface in an ultrasound image.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method of Hawkes to incorporate the segmentation using a convolutional neural network of Wilson to achieve the same results. One would have motivation to combine because it allows for automatic segmentation based on training data from previous imaging procedures and therefore provides an accurate segmentation result.
Claims 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hawkes (WO 2006092602), Hochmitz (US 20080178654), Ramadorai (US 20190290374), and Quiad (US 20060142657) as applied to claims 1 and 14 above, and further in view of Wiest (US 20170164835).
Regarding claims 4 and 17, Hawkes, Hochmitz, Ramadorai, and Quaid disclose all the elements of the claimed invention as cited in claims 1 and 14.
Hawkes discloses a first steered frame and a second steered frame of the ultrasound imaging (pg. 9 lines 20-22 – “a number of images are formed by electronically steering the US beam through several preset angles”).
Conversely Hawkes does not teach wherein the one or more controllers are further configured to calibrate the ultrasound imaging to reflect a variation in propagation speed of the ultrasound waves through the bone based on an estimated propagation speed, wherein to estimate propagation speed the one or more controllers minimize a cost function that optimizes an appearance of […] the ultrasound imaging.
However Wiest discloses wherein the one or more controllers are further configured to calibrate the ultrasound imaging to reflect a variation in propagation speed of the ultrasound waves through the bone based on an estimated propagation speed, wherein to estimate propagation speed the one or more controllers minimize a cost function that optimizes an appearance of […] the ultrasound imaging ([0054] – “to account for speed of sound changes between different organs and structures, an automated calibration of multiple speed of sound values is implemented”, [0056] – “initializing calibration objective function that takes as input the set of speed of sound values for multiple regions”, [0057] – “initialization of the starting speed of sound value can be conducted assuming homogeneous initial speed of sound distribution”, [0058] – “running the solver for the unknown speed of sound values that minimizes the objective function”, [0059] – “reconstructing an optoacoustic image using the map of fitted speed of sound values”, [0007] – “reconstruction of…images in two or three dimensions having high image quality”).
Wiest is an analogous art considering it is in the field of calibration of ultrasound imaging.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method of Hawkes to incorporate the propagation speed calibration of Wiest to achieve the same results. One would have motivation to combine because “The invention allows for a reconstruction of both optoacoustic (OA) images and ultrasound (US) images in two or three dimensions having high image quality” (Wiest [0007]).
Allowable Subject Matter
Claims 5 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/R.C.L./Examiner, Art Unit 3797
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