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 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 1-20 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 the limitation “identify a series of locations that do not cause the surgical instrument to collide with the subject in an undesired way” which renders the claim unclear. The terms “undesired way” renders the claim indefinite, it is not clear to a person ordinary in the art what the identification process entails.
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.
Claims 1-2, 4-5, 8, 10, 12-15, 18 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Danilchenko et al (US20220134558A1; hereinafter referred to as Danilchenko) in view of Roh et al (US20200085509A1; hereinafter referred to as Roh)
Regarding Claim 1, Danilchenko discloses a method (“surgical systems for orthopedic surgeries” [0002], “The processing circuit 260 includes a processor and memory device. The processor can be implemented as a general purpose processor, an application specific integrated circuit (ASIC), one or more field programmable gate arrays (FPGAs), a group of processing components, or other suitable electronic processing components.” [0032]) comprising:
positioning, by one or more processors, a 3D image of a subject relative to a frame of reference corresponding to a medical image of the subject (“processing circuit 260 is configured to facilitate the creation of a preoperative surgical plan prior to the surgical procedure. According to some embodiments, the preoperative surgical plan is developed utilizing a three-dimensional representation of a patient's anatomy, also referred to herein as a “virtual bone model.” A “virtual bone model” may include virtual representations of cartilage or other tissue in addition to bone. To obtain the virtual bone model, the processing circuit 260 receives imaging data of the patient's anatomy on which the surgical procedure is to be performed.” [0033], “The processing circuit 260 is configured to monitor the virtual positions of the virtual tool representation, the virtual bone model, and the control object (e.g., virtual haptic objects) corresponding to the real-world positions of the patient's bone (e.g., femur 206), the surgical tool 234, and one or more lines, planes, or three-dimensional spaces defined by forces created by robotic device 220. For example, if the patient's anatomy moves during the surgical procedure as tracked by the tracking system 222, the processing circuit 260 correspondingly moves the virtual bone model. The virtual bone model therefore corresponds to, or is associated with, the patient's actual (i.e. physical) anatomy and the position and orientation of that anatomy in real/physical space.” [0041]);
receiving, by the one or more processors, tracking data of a surgical instrument (“tracking system 222 includes a first fiducial tree 240 coupled to the tibia 208, a second fiducial tree 241 coupled to the femur 206, a third fiducial tree 242 coupled to the base 230, one or more fiducials coupled to surgical tool 234, and a detection device 246 configured to detect the three-dimensional position of fiducials (i.e., markers on fiducial trees 240-242).” [0028]);
determining, in real time by the one or more processors based on the tracking data, a location of the surgical instrument relative to a location of interest within the frame of reference (“Using the tracking system 222 of FIG. 2 or some other approach to surgical navigation and tracking, the surgical system 200 can determine the position of the surgical tool 234 relative to a patient's anatomical feature, for example femur 206, as the surgical tool 234 is used to modify the anatomical feature or otherwise facilitate the surgical procedure.” [0029]);
identifying, by the one or more processors, a series of locations that do not cause the surgical instrument to collide with the subject in an undesired way (“a planned path for moving the distal end of the robotic arm (and/or a surgical tool coupled thereto) from the initial pose to the target pose is generated. For example, the processing circuit 260 may generate the planned path based on the initial pose, the target pose, and one or more additional criteria. The target pose may include a position (e.g., such that a tool center point of the surgical tool is positioned in the target planed without regard to orientation of the surgical tool) or a position and an orientation (e.g., such that an axis of the surgical tool is in the plane at the target pose). Accordingly, the planned path can define positions of a tool center point of the surgical tool.” [0082], “generating the planned path can include accounting for one or more obstacles that may be between the initial pose and the target pose, for example anatomical features of the patient” [0083]);
generating, by the one or more processors, movement instructions for the surgical instrument based on the medical image, the location of interest, and the identified series of locations, the movement instructions configured to cause the surgical instrument to move to the location of interest within a targeted period of time (“generating the planned path can also include determining the rate of movement (e.g., velocity) of the tool along the planned path for automated movement of the surgical tool along the planned path. For example, the path and the velocity may be determined such that surgical tool will reach the target pose in a predetermined amount of time (preset duration)” [0084]);
controlling, by the one or more processors, the surgical instrument to perform a procedure at the location of interest (“At step 508, the robotic device is controlled to automatically move a surgical tool coupled thereto along the planned path. In the embodiment of FIG. 2, motors of the robotic device 220 are controlled (e.g., by the processing circuit 260) to automatically rotate joints of the robotic arm 232 such that a surgical tool 234 coupled to a distal end of the robotic arm 232 is moved along the planned path.” [0085]);
Danilchenko does not specifically disclose evaluating, by the one or more processors, a parameter of the procedure based on a threshold for the procedure and causing, by the one or more processors, the surgical instrument to terminate the procedure responsive to the parameter satisfying the threshold.
However, in a similar endeavor, Roh teaches a system and method for utilizing artificial intelligence to operate a surgical robot [Abstract].
Roh also teaches evaluating, by the one or more processors, a parameter of the procedure based on a threshold for the procedure (“As a drill or knife is robotically controlled, the drill or knife would have highly sensitive force transducers. These force transducers produce a real time X,Y,Z force set of data. The data is collected in many successful operations. The real-time images not only have all the previous metatags discussed, but also have the real time X,Y,Z force data. Now the system can be trained to show the delta force change going from one tissue type to another. As above, the change in force in X,Y,Z can be used to compare to real-time operations. If the tissues are identified correctly and within range, and the forces and changes of force are within range, the images are annotated with virtual information showing that tissues and forces and changes in force are in order” [0107]);
and causing, by the one or more processors, the surgical instrument to terminate the procedure responsive to the parameter satisfying the threshold (“If, however, the forces or changes of force appear out of normal range, alarms would sound, and automated robotic stops would be done to investigate the out of norm situation. With this system, the surgeon can create a “sensitivity” of force change at various parts of the operations, so the system may alarm when it approaches a nerve as the force and change of force alarm is set at a more sensitive level than another part of the operation.” [0107]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Danilchenko as outlined above with evaluating, by the one or more processors, a parameter of the procedure based on a threshold for the procedure and causing, by the one or more processors, the surgical instrument to terminate the procedure responsive to the parameter satisfying the threshold as taught by Roh, because it may alarm the user when the robotic system approaches a nerve [0107].
Regarding Claim 2, Danilchenko discloses further comprising controlling, by the one or more processors, a position of the surgical instrument based on the tracking data and at least one of a target movement of the surgical instrument or a target distance between the location of the surgical instrument and the location of interest (“the robotic device is controlled to automatically move a surgical tool coupled thereto along the planned path. In the embodiment of FIG. 2, motors of the robotic device 220 are controlled (e.g., by the processing circuit 260) to automatically rotate joints of the robotic arm 232 such that a surgical tool 234 coupled to a distal end of the robotic arm 232 is moved along the planned path. Step 508 can include determining a preferred set of joint rotations which result in movement of the surgical tool 234 along the planned path and are configured to ensure a desired range of motion following automatic alignment with the target plane.” [0085], “During automated movement of the surgical tool along the planned path, a position of the surgical tool (e.g., a tool center point) is tracked by the system.” [0087]).
Regarding Claim 4, Danilchenko discloses further comprising: transforming, by the one or more processors, the tracking data of the surgical instrument relative to the frame of reference to generate transformed tracking data; and rendering, by one or more processors, the transformed tracking data within a render of the medical image and the 3D image (“The processing circuit 260 is configured to monitor the virtual positions of the virtual tool representation, the virtual bone model, and the control object (e.g., virtual haptic objects) corresponding to the real-world positions of the patient's bone (e.g., femur 206), the surgical tool 234, and one or more lines, planes, or three-dimensional spaces defined by forces created by robotic device 220. For example, if the patient's anatomy moves during the surgical procedure as tracked by the tracking system 222, the processing circuit 260 correspondingly moves the virtual bone model. The virtual bone model therefore corresponds to, or is associated with, the patient's actual (i.e. physical) anatomy and the position and orientation of that anatomy in real/physical space.” [0041]).
Regarding Claim 5, Danilchenko discloses further comprising: generating, by the one or more processors, movement instructions for the surgical instrument based on the medical image and the location of interest; and transmitting, by the one or more processors, the movement instructions to the surgical instrument (“At step 508, the robotic device is controlled to automatically move a surgical tool coupled thereto along the planned path. In the embodiment of FIG. 2, motors of the robotic device 220 are controlled (e.g., by the processing circuit 260) to automatically rotate joints of the robotic arm 232 such that a surgical tool 234 coupled to a distal end of the robotic arm 232 is moved along the planned path. Step 508 can include determining a preferred set of joint rotations which result in movement of the surgical tool 234 along the planned path and are configured to ensure a desired range of motion following automatic alignment with the target plane.” [0085], “During automated movement of the surgical tool along the planned path, a position of the surgical tool (e.g., a tool center point) is tracked by the system. For example, the position of the surgical tool can be directly tracked by a tracking system (e.g., by tracking a marker attached to the surgical tool).” [0087]).
Regarding Claim 8, Danilchenko discloses further comprising causing, by the one or more processors, the surgical instrument to terminate energy emission responsive to (2) movement of the subject exceeding a movement threshold (“At step 512, in response to detection of a deviation of the surgical tool from the planned path in step 510, the automated motion of the robotic arm is stopped. That is, execution of step 508 is ended and the motors of the robotic device are no longer controlled to drive the robotic arm based on the planned path.” [0092]).
Regarding Claim 10, Danilchenko discloses further comprising: applying, by the one or more processors using a robotic arm coupled with the surgical instrument, a force to keep the surgical instrument in contact with a surface of the subject; and adjusting, by the one or more processors, the applied force based on the tracking data (“control of the motors or other actuators may be position-based, which the robotic device controlled to a desired pose. In compliant systems, the robotic device provides a spring-like force that acts to push the robotic device back into the desired pose. In embodiments where the robotic device is provided with active compliance, the motors or actuators are controlled to provide this spring-like force. In some cases, the force driving the robotic device back to the desired pose increases with the distance by which the robotic device has deviated from the desired pose.” [0074]).
Regarding Claim 12, Danilchenko discloses a system comprising (“surgical systems for orthopedic surgeries” [0002], “The processing circuit 260 includes a processor and memory device. The processor can be implemented as a general purpose processor, an application specific integrated circuit (ASIC), one or more field programmable gate arrays (FPGAs), a group of processing components, or other suitable electronic processing components.” [0032]) comprising:
a 3D camera configured to detect a 3D image of a subject (“Detection device 246 may be an optical detector such as a camera or infrared sensor. The fiducial trees 240-242 include fiducials, which are markers configured to show up clearly to the optical detector and/or be easily detectable by an image processing system using data from the optical detector, for example by being highly reflective of infrared radiation (e.g., emitted by an element of tracking system 222). A stereoscopic arrangement of cameras on detection device 246 allows the position of each fiducial to be determined in 3D-space through a triangulation approach.” [0028]);
a surgical instrument configured to apply a procedure to a location of interest on the subject (“Using the tracking system 222 of FIG. 2 or some other approach to surgical navigation and tracking, the surgical system 200 can determine the position of the surgical tool 234 relative to a patient's anatomical feature, for example femur 206, as the surgical tool 234 is used to modify the anatomical feature or otherwise facilitate the surgical procedure.” [0029]);
and one or more processors configured to: position the 3D image of a subject relative to a frame of reference corresponding to a medical image of the subject (“processing circuit 260 is configured to facilitate the creation of a preoperative surgical plan prior to the surgical procedure. According to some embodiments, the preoperative surgical plan is developed utilizing a three-dimensional representation of a patient's anatomy, also referred to herein as a “virtual bone model.” A “virtual bone model” may include virtual representations of cartilage or other tissue in addition to bone. To obtain the virtual bone model, the processing circuit 260 receives imaging data of the patient's anatomy on which the surgical procedure is to be performed.” [0033], “The processing circuit 260 is configured to monitor the virtual positions of the virtual tool representation, the virtual bone model, and the control object (e.g., virtual haptic objects) corresponding to the real-world positions of the patient's bone (e.g., femur 206), the surgical tool 234, and one or more lines, planes, or three-dimensional spaces defined by forces created by robotic device 220. For example, if the patient's anatomy moves during the surgical procedure as tracked by the tracking system 222, the processing circuit 260 correspondingly moves the virtual bone model. The virtual bone model therefore corresponds to, or is associated with, the patient's actual (i.e. physical) anatomy and the position and orientation of that anatomy in real/physical space.” [0041]);
receive tracking data of the surgical instrument (“tracking system 222 includes a first fiducial tree 240 coupled to the tibia 208, a second fiducial tree 241 coupled to the femur 206, a third fiducial tree 242 coupled to the base 230, one or more fiducials coupled to surgical tool 234, and a detection device 246 configured to detect the three-dimensional position of fiducials (i.e., markers on fiducial trees 240-242).” [0028]);
determine, in real time based on the tracking data, a location of the surgical instrument relative to a location of interest within the frame of reference (“Using the tracking system 222 of FIG. 2 or some other approach to surgical navigation and tracking, the surgical system 200 can determine the position of the surgical tool 234 relative to a patient's anatomical feature, for example femur 206, as the surgical tool 234 is used to modify the anatomical feature or otherwise facilitate the surgical procedure.” [0029]);
identify a series of locations that do not cause the surgical instrument to collide with the subject in an undesired way (“a planned path for moving the distal end of the robotic arm (and/or a surgical tool coupled thereto) from the initial pose to the target pose is generated. For example, the processing circuit 260 may generate the planned path based on the initial pose, the target pose, and one or more additional criteria. The target pose may include a position (e.g., such that a tool center point of the surgical tool is positioned in the target planed without regard to orientation of the surgical tool) or a position and an orientation (e.g., such that an axis of the surgical tool is in the plane at the target pose). Accordingly, the planned path can define positions of a tool center point of the surgical tool.” [0082], “generating the planned path can include accounting for one or more obstacles that may be between the initial pose and the target pose, for example anatomical features of the patient” [0083]);
generate movement instructions for the surgical instrument based on the medical image, the location of interest, and the identified series of locations, the movement instructions configured to cause the surgical instrument to move to the location of interest within a targeted period of time (“generating the planned path can also include determining the rate of movement (e.g., velocity) of the tool along the planned path for automated movement of the surgical tool along the planned path. For example, the path and the velocity may be determined such that surgical tool will reach the target pose in a predetermined amount of time (preset duration)” [0084]);
control the surgical instrument to perform a procedure at the location of interest (“At step 508, the robotic device is controlled to automatically move a surgical tool coupled thereto along the planned path. In the embodiment of FIG. 2, motors of the robotic device 220 are controlled (e.g., by the processing circuit 260) to automatically rotate joints of the robotic arm 232 such that a surgical tool 234 coupled to a distal end of the robotic arm 232 is moved along the planned path.” [0085]);
Danilchenko does not specifically disclose that the one or more processors are configured to: evaluate a parameter of the procedure based on a threshold for the procedure and cause the surgical instrument to terminate the procedure responsive to the parameter satisfying the threshold.
However, in a similar endeavor, Roh teaches a system and method for utilizing artificial intelligence to operate a surgical robot [Abstract].
Roh also teaches that the one or more processors are configured to: evaluate a parameter of the procedure based on a threshold for the procedure (“As a drill or knife is robotically controlled, the drill or knife would have highly sensitive force transducers. These force transducers produce a real time X,Y,Z force set of data. The data is collected in many successful operations. The real-time images not only have all the previous metatags discussed, but also have the real time X,Y,Z force data. Now the system can be trained to show the delta force change going from one tissue type to another. As above, the change in force in X,Y,Z can be used to compare to real-time operations. If the tissues are identified correctly and within range, and the forces and changes of force are within range, the images are annotated with virtual information showing that tissues and forces and changes in force are in order” [0107]);
and cause the surgical instrument to terminate the procedure responsive to the parameter satisfying the threshold (“If, however, the forces or changes of force appear out of normal range, alarms would sound, and automated robotic stops would be done to investigate the out of norm situation. With this system, the surgeon can create a “sensitivity” of force change at various parts of the operations, so the system may alarm when it approaches a nerve as the force and change of force alarm is set at a more sensitive level than another part of the operation.” [0107]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Danilchenko as outlined above with the one or more processors are configured to: evaluate a parameter of the procedure based on a threshold for the procedure and cause the surgical instrument to terminate the procedure responsive to the parameter satisfying the threshold as taught by Roh, because it may alarm the user when the robotic system approaches a nerve [0107].
Regarding Claim 13, Danilchenko discloses the one or more processors are further configured to control the position of the surgical instrument based on the tracking data and at least one of a target movement of the surgical instrument or a target distance between the location of the surgical instrument and the location of interest (“the robotic device is controlled to automatically move a surgical tool coupled thereto along the planned path. In the embodiment of FIG. 2, motors of the robotic device 220 are controlled (e.g., by the processing circuit 260) to automatically rotate joints of the robotic arm 232 such that a surgical tool 234 coupled to a distal end of the robotic arm 232 is moved along the planned path. Step 508 can include determining a preferred set of joint rotations which result in movement of the surgical tool 234 along the planned path and are configured to ensure a desired range of motion following automatic alignment with the target plane.” [0085], “During automated movement of the surgical tool along the planned path, a position of the surgical tool (e.g., a tool center point) is tracked by the system.” [0087]).
Regarding Claim 14, Danilchenko discloses the one or more processors are further configured to: transform the tracking data from the surgical instrument to the frame of reference to generate transformed tracking data; and render the transformed tracking data within a render of the medical image and the 3D image (“The processing circuit 260 is configured to monitor the virtual positions of the virtual tool representation, the virtual bone model, and the control object (e.g., virtual haptic objects) corresponding to the real-world positions of the patient's bone (e.g., femur 206), the surgical tool 234, and one or more lines, planes, or three-dimensional spaces defined by forces created by robotic device 220. For example, if the patient's anatomy moves during the surgical procedure as tracked by the tracking system 222, the processing circuit 260 correspondingly moves the virtual bone model. The virtual bone model therefore corresponds to, or is associated with, the patient's actual (i.e. physical) anatomy and the position and orientation of that anatomy in real/physical space.” [0041]).
Regarding Claim 15, Danilchenko discloses the one or more processors are further configured to: transmit the movement instructions to the surgical instrument (“At step 508, the robotic device is controlled to automatically move a surgical tool coupled thereto along the planned path. In the embodiment of FIG. 2, motors of the robotic device 220 are controlled (e.g., by the processing circuit 260) to automatically rotate joints of the robotic arm 232 such that a surgical tool 234 coupled to a distal end of the robotic arm 232 is moved along the planned path. Step 508 can include determining a preferred set of joint rotations which result in movement of the surgical tool 234 along the planned path and are configured to ensure a desired range of motion following automatic alignment with the target plane.” [0085], “During automated movement of the surgical tool along the planned path, a position of the surgical tool (e.g., a tool center point) is tracked by the system. For example, the position of the surgical tool can be directly tracked by a tracking system (e.g., by tracking a marker attached to the surgical tool).” [0087]).
Regarding Claim 18, Danilchenko discloses the one or more processors are further configured to cause the surgical instrument to terminate energy emission responsive to at least one of (1) the location of interest not being within the frame of reference or (2) movement of the subject exceeding a movement threshold (“At step 512, in response to detection of a deviation of the surgical tool from the planned path in step 510, the automated motion of the robotic arm is stopped. That is, execution of step 508 is ended and the motors of the robotic device are no longer controlled to drive the robotic arm based on the planned path.” [0092]).
Regarding Claim 20, Danilchenko discloses the one or more processors are further configured to: apply, using a robotic arm coupled with the surgical instrument, a force to keep the surgical instrument in contact with a surface of the subject; and adjust the applied force based on the tracking data (“control of the motors or other actuators may be position-based, which the robotic device controlled to a desired pose. In compliant systems, the robotic device provides a spring-like force that acts to push the robotic device back into the desired pose. In embodiments where the robotic device is provided with active compliance, the motors or actuators are controlled to provide this spring-like force. In some cases, the force driving the robotic device back to the desired pose increases with the distance by which the robotic device has deviated from the desired pose.” [0074]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Danilchenko in view of Roh as applied to Claim 1, and further in view of Joskowicz et al (US20090177081A1; hereinafter referred to as Joskowicz)
Regarding Claim 3, Danilchenko in view of Roh discloses all limitations noted above except that the location of interest is on a surface of a head of the subject.
However, in a similar field of endeavor, Joskowicz teaches a novel image-guided system for precise automatic targeting in minimally invasive keyhole neurosurgery [Abstract].
Joskowicz also teaches that the location of interest is on a surface of a head of the subject (“The system consists of a miniature robot fitted with a mechanical guide for needle, probe, or catheter insertion. Intraoperative, the robot is directly affixed to a head clamp or to the patient skull. It automatically positions itself with respect to predefined entry points and targets in a preoperative CT/MRI image following an anatomical registration with an intraoperative 3D surface scan of the patient facial features and a registration jig.” [Abstract])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Danilchenko in view of Roh as outlined above with the location of interest is on a surface of a head of the subject as taught by Joskowicz, because minimally invasive procedures of the brain are difficult to perform without the help of support systems that enhance the accuracy and steadiness of the surgical gestures [0002].
Claims 6-7, & 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Danilchenko et al in view of Roh as applied to claims 1 & 12,and further in view of Lang (US20210267691A1)
Regarding Claim 6, Danilchenko in view of Roh discloses all limitations noted above except further comprising displaying a highlighted region for the location of interest within a render of the medical image.
However, in a similar field of endeavor, Lang teaches devices and methods for performing a surgical step or surgical procedure with visual guidance
Lang also teaches further comprising displaying a highlighted region for the location of interest within a render of the medical image (“The surgeon can also mark sensitive tissue, e.g. nerves, brain structure, vessels etc., that the surgeon wants to preserve or protect during the surgery. Such sensitive structure(s) can be highlighted, for example using different colors, when the virtual surgical plan and the related anatomic data or pathologic tissue information is being transmitted to or displayed by the OHMD.” [0092]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Danilchenko in view of Roh as outlined above with further comprising displaying a highlighted region for the location of interest within a render of the medical image as taught by Lang, because it can mark sensitive regions that the surgeon wants to protect during the surgery [0092].
Regarding Claim 7, Danilchenko in view of Roh discloses all limitations noted above except further comprising displaying a highlighted region for the location of interest within a render of the medical image.
However, in a similar field of endeavor, Lang teaches further comprising determining, by the one or more processors, a distance of the subject represented in the medical image from an image capture device to detect the 3D image (“the OHMD can transmit data back to a computer, a server or a workstation. Such data can include, but are not limited to: Distance data, e.g. parallax data generated by two or more image and/or video capture systems evaluating changes in distance between the OHMD and a surgical field or an object” [0081,0088]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Danilchenko in view of Roh as outlined above with further comprising displaying a highlighted region for the location of interest within a render of the medical image as taught by Lang, because the accuracy of registration can be improved [0688].
Regarding Claim 16, Danilchenko in view of Roh discloses all limitations noted above except further comprising displaying a highlighted region for the location of interest within a render of the medical image.
However, in a similar field of endeavor, Lang teaches devices and methods for performing a surgical step or surgical procedure with visual guidance
Lang also teaches further comprising displaying a highlighted region for the location of interest within a render of the medical image (“The surgeon can also mark sensitive tissue, e.g. nerves, brain structure, vessels etc., that the surgeon wants to preserve or protect during the surgery. Such sensitive structure(s) can be highlighted, for example using different colors, when the virtual surgical plan and the related anatomic data or pathologic tissue information is being transmitted to or displayed by the OHMD.” [0092]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Danilchenko in view of Roh as outlined above with further comprising displaying a highlighted region for the location of interest within a render of the medical image as taught by Lang, because it can mark sensitive regions that the surgeon wants to protect during the surgery [0092].
Regarding Claim 17, Danilchenko in view of Roh discloses all limitations noted above except further comprising displaying a highlighted region for the location of interest within a render of the medical image.
However, in a similar field of endeavor, Lang teaches further comprising determining, by the one or more processors, a distance of the subject represented in the medical image from an image capture device to detect the 3D image (“the OHMD can transmit data back to a computer, a server or a workstation. Such data can include, but are not limited to: Distance data, e.g. parallax data generated by two or more image and/or video capture systems evaluating changes in distance between the OHMD and a surgical field or an object” [0081,0088]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Danilchenko in view of Roh as outlined above with further comprising displaying a highlighted region for the location of interest within a render of the medical image as taught by Lang, because the accuracy of registration can be improved [0688].
Claims 9 & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Danilchenko in view of Roh as applied to Claim 1 & 12; and further in view of McKinnon et al (US20220079678A1; hereinafter referred to as McKinnon).
Regarding Claim 9, Danilchenko in view of Roh discloses further comprising: receiving, by the one or more processors, an indication of data associated between the surgical instrument and the subject; and controlling, by the one or more processors, operation of the surgical instrument further based on the data (“control of the motors or other actuators may be position-based, which the robotic device controlled to a desired pose. In compliant systems, the robotic device provides a spring-like force that acts to push the robotic device back into the desired pose. In embodiments where the robotic device is provided with active compliance, the motors or actuators are controlled to provide this spring-like force. In some cases, the force driving the robotic device back to the desired pose increases with the distance by which the robotic device has deviated from the desired pose.” [Danilchenko 0074]).
Danilchenko in view of Roh does not specifically teach the data being torque data associated with contact between the surgical instrument and the subject.
However, in a similar field of endeavor, McKinnon teaches a method for creating a patient-specific surgical plan [Abstract].
McKinnon also teaches that the data is torque data associated with contact between the surgical instrument and the subject (“a GUI that provides a visual depiction of the knee during tissue resection may provide the measured torque and displacement of the resection equipment adjacent to the visual depiction to better provide an understanding of any deviations that occurred from the planned resection area.” [0218])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Danilchenko in view of Roh as outlined above with the data being torque data associated with contact between the surgical instrument and the subject as taught by McKinnon, because it would better provide an understanding of any deviations that occurred from the planned resection area [0218].
Regarding Claim 19, Danilchenko in view of Roh discloses further comprising: receiving, by the one or more processors, an indication of data associated between the surgical instrument and the subject; and controlling, by the one or more processors, operation of the surgical instrument further based on the data (“control of the motors or other actuators may be position-based, which the robotic device controlled to a desired pose. In compliant systems, the robotic device provides a spring-like force that acts to push the robotic device back into the desired pose. In embodiments where the robotic device is provided with active compliance, the motors or actuators are controlled to provide this spring-like force. In some cases, the force driving the robotic device back to the desired pose increases with the distance by which the robotic device has deviated from the desired pose.” [Danilchenko 0074]).
Danilchenko in view of Roh does not specifically teach the data being torque data associated with contact between the surgical instrument and the subject.
However, in a similar field of endeavor, McKinnon teaches a method for creating a patient-specific surgical plan [Abstract].
McKinnon also teaches that the data is torque data associated with contact between the surgical instrument and the subject (“a GUI that provides a visual depiction of the knee during tissue resection may provide the measured torque and displacement of the resection equipment adjacent to the visual depiction to better provide an understanding of any deviations that occurred from the planned resection area.” [0218])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Danilchenko in view of Roh as outlined above with the data being torque data associated with contact between the surgical instrument and the subject as taught by McKinnon, because it would better provide an understanding of any deviations that occurred from the planned resection area [0218].
Claims 11 are rejected under 35 U.S.C. 103 as being unpatentable over Danilchenko et al in view of Roh and further in view of Schein (US20210100526A1; hereinafter referred to as Schein)
Regarding Claim 11, Danilchenko in view of Roh discloses all limitations noted above except that the surgical instrument is configured to perform the procedure as a focused ultrasound procedure, the method further comprising steering, by the one or more processors, an ultrasound beam outputted by the surgical instrument based on the tracking data.
However; in a similar field of endeavor, Schein teaches methods and systems are provided for tracking anatomical features across multiple images [Abstract].
Schein also teaches the surgical instrument is configured to perform the procedure as a focused ultrasound procedure, the method further comprising steering, by the one or more processors, an ultrasound beam outputted by the surgical instrument based on the tracking data (“At 526, method 500 optionally includes adjusting one or more ultrasound imaging parameters based on the tracked anatomical features. For example, one or more of ultrasound transducer frequency, imaging depth, image gain, beam steering, and/or other imaging parameters may be automatically adjusted in order to maintain a tracked anatomical feature in view, to maintain a desired imaging plane of a tracked anatomical feature in view, etc. For example, if an anatomical feature of interest is moving up or down, the focus of the ultrasound probe may be adjusted to follow the anatomical feature. Additionally, frequency may be optimized to depth (e.g., higher frequency for shallower images).” [0093])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Lang as outlined above with the surgical instrument is configured to perform the procedure as a focused ultrasound procedure, the method further comprising steering, by the one or more processors, an ultrasound beam outputted by the surgical instrument based on the tracking data as taught by Schein, because it can maintain a desired imaging plane of a tracked anatomical feature in view.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure (US 20210369349 A1, US 20220313366 A1, US 20170245944 A1, US 20230038498 A1).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN MALDONADO whose telephone number is 703-756-1421. The examiner can normally be reached 8:00 am-4:00 pm PST M-Th Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at
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/Steven Maldonado/
Patent Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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