DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The proposed reply filled on 07/02/2026 has been entered. Claims 19-22 and 25-38 remain pending in the current application. The amendment have overcome the claim objection of claim 29.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 19, 26-29, and 33-38 are rejected under 35 U.S.C. 103 as being unpatentable over Schotzko et al. (US 2019/0307518) in the view of Washburn et al. (US 2008/0221446) and Kozokaro et al (US 2022/0142705).
Regarding claim 19, Schotzko teaches a system comprising (Figure 1, para. 0041; a treatment system 10):
an imaging device configured to capture images of a heart of a patient from outside the patient's body, the imaging device comprising a first position sensor (fig. 1, element 140, para. 0042; Ultrasound imager 140 may have an EM tracking sensor embedded within or attached to the ultrasound wand, for example, a clip-on sensor, or a sticker sensor. As described further herein, ultrasound imager 140 may be positioned in relation to instrument 130 such that the instrument is at an angle to the ultrasound image plane, thereby enabling the clinician to visualize the spatial relationship of the instrument with the ultrasound image plane and with objects being imaged.);
a needle designed for transthoracic insertion into the patient, the needle having a distal end and a proximal end, the needle comprising a second position sensor disposed over the distal end (figure 1, element 130, paras. 0042-0044; instrument 130, inside the patient's body, The location of the instrument 130 within the body of the patient may be tracked during the surgical procedure. The location of the instrument 130 within the body of the patient may be tracked during the surgical procedure. An exemplary method of tracking the location of the instrument 130 includes using the EM tracking system, which tracks the location of the instrument by tracking sensors attached to or incorporated in the instrument.);
a position system configured to:
track a position of the first position sensor in a coordinate system defined by the position system (paras. 0041-0042; EM field generator 121 is used to generate an EM field during the procedure and forms part of an EM tracking system that is used to track the positions of one or more surgical instruments within the body of a patient. In addition to the EM tracking system, the instrument 130 may also be visualized by using ultrasound imaging. Ultrasound imager 140, such as an ultrasound wand, may be used to image the patient's body during the procedure to visualize the location of the surgical instruments, such as instrument 130, inside the patient's body. Ultrasound imager 140 may have an EM tracking sensor embedded within or attached to the ultrasound wand, for example, a clip-on sensor, or a sticker sensor.);
track a position of the second position sensor in the coordinate system defined by the position system (paras. 0041-0043; EM field generator 121 is used to generate an EM field during the procedure and forms part of an EM tracking system that is used to track the positions of one or more surgical instruments within the body of a patient. In addition to the EM tracking system, the instrument 130 may also be visualized by using ultrasound imaging. Ultrasound imager 140, such as an ultrasound wand, may be used to image the patient's body during the procedure to visualize the location of the surgical instruments, such as instrument 130, inside the patient's body. Ultrasound imager 140 may have an EM tracking sensor embedded within or attached to the ultrasound wand, for example, a clip-on sensor, or a sticker sensor. The location of the instrument 130 within the body of the patient may be tracked during the surgical procedure. An exemplary method of tracking the location of the instrument 130 includes using the EM tracking system, which tracks the location of the instrument by tracking sensors attached to or incorporated in the instrument.); and
a processor configured to (figure 1, element 100, para. 0041):
during an image capturing step: display the images on a display device (para. 0071; GUI 301 includes side-by-side depictions of ultrasound image plane 325);
receive a location of an anatomical landmark while the imaging device is disposed in a selection position having a location and an orientation (paras. 0072 and 0076; the controller 204 of the computing device 100 of system 10 can be adapted to also identify one or more physiological landmarks within the region of the patient and generate one or more markers, icons, or indicia in the GUI 300 that augments these one or more physiological landmarks so that the clinician can more readily identify them during the procedure. The graphical user interface 300 includes at least one marker representative of the physiological landmark. At 406, one or more physiological landmarks based on the ultrasound image data can be identified either by the clinician or the controller 204 using any suitable technique or techniques.);
receive the location and the orientation of the selection position of the imaging device (para. 0075; At 402, ultrasound image data can be received from the ultrasound sensor or imager 140 by the computing device 100. The ultrasound image data may be relayed from ultrasound workstation 150. Next, or concurrently with step 402, computing device 100 receives EM tracking data from the EM tracking system for ultrasound imager 140 and the instrument 130 at 404. The EM tracking data is representative of positions and orientations of each of the ultrasound sensor and the instrument 130 relative to the region of the patient.); and
during a subsequent needle insertion step following the image capturing step: display on the display device a real-time visualization of the distal end of the needle in the coordinate system (paras. 0076-0077; Computing device 100 can determine at least one of a position, orientation, or trajectory of the instrument 130 based on the EM tracking data at 408 using any suitable technique or techniques. At 410, the controller 204 of the computing device 100 can generate a GUI 300 showing at least one of a position, orientation, or trajectory of the instrument 130 relative to the plane 325 of the ultrasound image data, which is based on the ultrasound image data received from ultrasound imager 140, and a target zone that is registered with the one or more physiological landmarks identified at 406. The examiner notes that the trajectory is displayed in real time based on the position data of the needle); and
display on the display device a visual indication of the coordinates of the anatomical landmark (para. 0077; At 410, the controller 204 of the computing device 100 can generate a GUI 300 showing at least one of a position, orientation, or trajectory of the instrument 130 relative to the plane 325 of the ultrasound image data, which is based on the ultrasound image data received from ultrasound imager 140, and a target zone that is registered with the one or more physiological landmarks identified at 406.);
display on the display device a straight trajectory extending from the real-time visualization of the distal end of the needle to the visual indication of the coordinates of the anatomical landmark (paras. 0059 and 0077, At 410, the controller 204 of the computing device 100 can generate a GUI 300 showing at least one of a position, orientation, or trajectory of the instrument 130 relative to the plane 325 of the ultrasound image data, which is based on the ultrasound image data received from ultrasound imager 140, and a target zone that is registered with the one or more physiological landmarks identified at 406. The examiner notes that the system generates a trajectory for the instrument to travel from current position to the target point/landmark.);
calculate updated coordinates of the distal end of the needle based on an advancement of the distal end of the needle relative to the anatomical landmark (para. 0078; the controller 204 can be adapted to determine whether at least one of the position, orientation, or trajectory of the instrument 130 has changed. If yes, then the controller 204 can be adapted to generate an updated graphical user interface showing at least one of an updated position, orientation, or trajectory of the instrument. These steps may be performed interchangeably and/or concurrently and can be performed iteratively throughout the procedure.);
calculate updated coordinates of the anatomical landmark based on movement of the anatomical landmark (paras. 0072-0073; the controller 204 of the computing device 100 of system 10 can be adapted to also identify one or more physiological landmarks within the region of the patient and generate one or more markers, icons, or indicia in the GUI 300 that augments these one or more physiological landmarks so that the clinician can more readily identify them during the procedure. In one or more embodiments, the controller 204 is adapted to attach these markers to the physiological landmarks such that the markers are dynamic. In other words, the markers are attached to the physiological landmarks such that the markers move in registration with the landmarks in the GUI 300. Such registration of the markers with the physiological landmarks can aid the clinician in guiding the instrument 130 and/or one or more devices to the target region of the patient even though the patient or the region is moving in connection, e.g., with inhalation and exhalation and/or the beating of a heart of the patient.);
display on the display device an updated real-time visualization of the distal end of the needle in the coordinate system based on the updated coordinates of the distal end of the needle (para. 0078; the controller 204 can be adapted to determine whether at least one of the position, orientation, or trajectory of the instrument 130 has changed. If yes, then the controller 204 can be adapted to generate an updated graphical user interface showing at least one of an updated position, orientation, or trajectory of the instrument. These steps may be performed interchangeably and/or concurrently and can be performed iteratively throughout the procedure.);
display on the display device an updated visual indication of the coordinates of the anatomical landmark based on motion of the anatomical landmark (paras. 0072-0073 and 0077; the controller 204 of the computing device 100 of system 10 can be adapted to also identify one or more physiological landmarks within the region of the patient and generate one or more markers, icons, or indicia in the GUI 300 that augments these one or more physiological landmarks so that the clinician can more readily identify them during the procedure. In one or more embodiments, the controller 204 is adapted to attach these markers to the physiological landmarks such that the markers are dynamic. In other words, the markers are attached to the physiological landmarks such that the markers move in registration with the landmarks in the GUI 300. Such registration of the markers with the physiological landmarks can aid the clinician in guiding the instrument 130 and/or one or more devices to the target region of the patient even though the patient or the region is moving in connection, e.g., with inhalation and exhalation and/or the beating of a heart of the patient. At 410, the controller 204 of the computing device 100 can generate a GUI 300 showing at least one of a position, orientation, or trajectory of the instrument 130 relative to the plane 325 of the ultrasound image data, which is based on the ultrasound image data received from ultrasound imager 140, and a target zone that is registered with the one or more physiological landmarks identified at 406.);
and display on the display device an updated straight trajectory from the updated real-time visualization of the distal end of the needle to the updated visual indication of the coordinates of the anatomical landmark (paras. 0072-0073, 0078, and 0086; In one or more embodiments, the controller 204 is adapted to attach these markers to the physiological landmarks such that the markers are dynamic. In other words, the markers are attached to the physiological landmarks such that the markers move in registration with the landmarks in the GUI 300. Such registration of the markers with the physiological landmarks can aid the clinician in guiding the instrument 130 and/or one or more devices to the target region of the patient even though the patient or the region is moving in connection, e.g., with inhalation and exhalation and/or the beating of a heart of the patient. application 216 includes one or more machine learning algorithms to identify one or more physiological landmarks within the region of the patient and/or to provide an optimum trajectory for guiding a surgical instrument and/or medical device through a region of a patient based on data acquired during the procedure and/or data acquired prior to the procedure. The machine learning algorithms can also adjust the trajectory as the procedure advances. In one or more embodiments, the controller 204 can be adapted to determine whether at least one of the position, orientation, or trajectory of the instrument 130 has changed. If yes, then the controller 204 can be adapted to generate an updated graphical user interface showing at least one of an updated position, orientation, or trajectory of the instrument. The examiner notes that the processor determines a change in the location of a landmark due to inhalation, exhalation, or heart beats, and updates a graphical marker representing the landmark based on the updated location. The processor additionally, tracks the pose of the instrument in real time and updates the graphical representation of the pose of the instrument in real time. Additionally, the processor determines the optimal trajectory of the needle (Which is also displayed) to reach the identified treatment region based on data acquired during the procedure (which includes position data of the needle and the probe, and the location of the landmark). The machine learning algorithms can also adjust the trajectory as the procedure advances. Which means that the trajectory is also updated based on the location of the needle in real time, as it is advances).
Although Schotzko teaches tracking the anatomical landmark movement through registration, however, Schotzko fails to explicitly teach calculate coordinates of the anatomical landmark in the coordinate system using the location of the anatomical landmark and the location and orientation of the selection position of the imaging device; store the coordinates of the anatomical landmark in memory associated with the processor; track movement of the heart over a breathing cycle; and receive electrical signals indicative of motion of the anatomical landmark.
Washburn, in the same field of endeavor, teaches calculate coordinates of the anatomical landmark in the coordinate system using the location of the anatomical landmark and the location and orientation of the selection position of the imaging device (paras. 0025-0027 and 0029; A position sensor 134 is mounted on or within the probe 106. The position sensing module 130 tracks movements of the position sensor 134 within the spatial detection field, creating positional information within a reference coordinate system module 146. As points or structures are identified by the user, the image tracking module 124 uses positional information acquired by the position sensing module 130 to determine and store location information of the structures of interest within the reference coordinate system module 146. The examiner notes that the location (coordinates) of the landmark in the coordinate system is determined based on the location of the selected point and the position information of the ultrasound probe in the reference coordinate system.); store the coordinates of the anatomical landmark in memory associated with the processor (para. 0029; As points or structures are identified by the user, the image tracking module 124 uses positional information acquired by the position sensing module 130 to determine and store location information of the structures of interest within the reference coordinate system module 146.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the steps of determining the anatomical landmarks of Schotzko with the steps of determining the coordinates anatomical landmarks and storing them in the memory, as taught by Washburn, because such modification would eliminate the need to move the probe for visualizing the landmark and away from the needle as disclosed within Washburn in paras. 0068 and 0077. By using stored coordinated of anatomical landmark, the user can use the probe to visualize the needle insertion to the predefined anatomical landmarks.
However, Schotzko in the view of Washburn fail to teach track movement of the heart over a breathing cycle; and receive electrical signals indicative of motion of the anatomical landmark.
Kozokaro, in the same field of endeavor, teaches an electrical location detection system configured to track movement of the heart over a breathing cycle (para. 0023; the sensor 5 includes at least six sensors formed as patches. In this embodiment, three of the sensors are attached to a patient's chest and three of the sensors are attached to a patient's back. In one aspect, the sensors 5 can be configured to measure inter-impedance among the sensors 5. These sensors 5 assist with modeling a patient's respiratory cycle, and identifying when a patient's lungs are breathing in or out. In one embodiment, when the lungs inflate or fill with air, then the impedance increases.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the motion compensation method of Schotzko in the view of Washburn with the motion compensation method used for modeling a patient's respiratory cycle of Kozokaro, because such modification would improve needle navigation because it would provide an accurate location of the needle and the anatomical landmark regardless of patient motion due to breathing.
Regarding claim 26, Schotzko the system of claim 19, wherein the imaging system is a handheld ultrasound probe (figure 1, para. 0042; Ultrasound imager 140, such as an ultrasound wand, may be used to image the patient's body during the procedure to visualize the location of the surgical instruments, such as instrument 130, inside the patient's body. The examiner notes that the ultrasound imager is an ultrasound handheld probe as shown in figure 1).
Regarding claim 27, Schotzko the system of claim 19, wherein the imaging system is a single-plane or bi-plane fluoroscopy imaging system (para. 0003; Image-guided medical and surgical procedures utilize patient images obtained prior to or during a medical procedure to guide a clinician performing the procedure. Recent advances in imaging technology, especially in imaging technologies that produce highly-detailed, two, three, and four-dimensional images, such as computed tomography (CT), magnetic resonance imaging (MRI), isocentric C-arm fluoroscopic imaging, positron emission tomography (PET), and ultrasound imaging (US), have heightened the interest in image-guided medical procedures. The examiner notes that Schotzko disclose that different imaging modalities can be used to image guide a procedure which includes fluoroscopic imaging).
Regarding claim 28, Schotzko the system of claim 19, wherein the anatomical landmark is the apex of the heart (para. 0084; physiological landmarks such as the mitral valve, IV septum, LV apex, aortic valve, etc., can be identified by the system 10 using any suitable technique).
Regarding claim 29, Schotzko teaches a method comprising (Figure 1, para. 0041):
capturing ultrasound images of a heart of a patient using an ultrasound imaging device positioned outside a patient’s body, the imaging device comprising a first position sensor (fig. 1, element 140, para. 0042; Ultrasound imager 140 may have an EM tracking sensor embedded within or attached to the ultrasound wand, for example, a clip-on sensor, or a sticker sensor. As described further herein, ultrasound imager 140 may be positioned in relation to instrument 130 such that the instrument is at an angle to the ultrasound image plane, thereby enabling the clinician to visualize the spatial relationship of the instrument with the ultrasound image plane and with objects being imaged.);
tracking, with a position system, a location and an orientation of first position sensor in a coordinate system (paras. 0041-0042 and 0075; EM field generator 121 is used to generate an EM field during the procedure and forms part of an EM tracking system that is used to track the positions of one or more surgical instruments within the body of a patient. In addition to the EM tracking system, the instrument 130 may also be visualized by using ultrasound imaging. Ultrasound imager 140, such as an ultrasound wand, may be used to image the patient's body during the procedure to visualize the location of the surgical instruments, such as instrument 130, inside the patient's body. Ultrasound imager 140 may have an EM tracking sensor embedded within or attached to the ultrasound wand, for example, a clip-on sensor, or a sticker sensor. Next, or concurrently with step 402, computing device 100 receives EM tracking data from the EM tracking system for ultrasound imager 140 and the instrument 130 at 404. The EM tracking data is representative of positions and orientations of each of the ultrasound sensor and the instrument 130 relative to the region of the patient.);
during an image capturing step (para. 0075):
displaying the ultrasound images on a display device; (para. 0071; GUI 301 includes side-by-side depictions of ultrasound image plane 325);
receiving a selection of an anatomical landmark on one of the ultrasound images while the imaging device is disposed in a selection position having a location and an orientation (paras. 0072 and 0076; the controller 204 of the computing device 100 of system 10 can be adapted to also identify one or more physiological landmarks within the region of the patient and generate one or more markers, icons, or indicia in the GUI 300 that augments these one or more physiological landmarks so that the clinician can more readily identify them during the procedure. The graphical user interface 300 includes at least one marker representative of the physiological landmark. At 406, one or more physiological landmarks based on the ultrasound image data can be identified either by the clinician or the controller 204 using any suitable technique or techniques.);
during a subsequent needle insertion step following the image capturing step: tracking a second position sensor disposed on a distal end of a needle in the coordinate system (figure 1, element 130, paras. 0042-0043 and 0078; The location of the instrument 130 within the body of the patient may be tracked during the surgical procedure. An exemplary method of tracking the location of the instrument 130 includes using the EM tracking system, which tracks the location of the instrument by tracking sensors attached to or incorporated in the instrument. Next, or concurrently with step 402, computing device 100 receives EM tracking data from the EM tracking system for ultrasound imager 140 and the instrument 130 at 404. The EM tracking data is representative of positions and orientations of each of the ultrasound sensor and the instrument 130 relative to the region of the patient.); and
displaying, on the display device, a real-time visualization of the distal end of the needle in the coordinate system (paras. 0077-0078; At 410, the controller 204 of the computing device 100 can generate a GUI 300 showing at least one of a position, orientation, or trajectory of the instrument 130 relative to the plane 325 of the ultrasound image data, which is based on the ultrasound image data received from ultrasound imager 140, and a target zone that is registered with the one or more physiological landmarks identified at 406. These steps may be performed interchangeably and/or concurrently and can be performed iteratively throughout the procedure. The examiner notes that the trajectory is displayed in real time based on the position data of the needle and the steps are performed in order where the image capturing step is followed by selecting anatomical landmarks then calculating trajectory of the needle.); display on the display device a real-time visualization of the distal end of the needle in the coordinate system (paras. 0076-0077; Computing device 100 can determine at least one of a position, orientation, or trajectory of the instrument 130 based on the EM tracking data at 408 using any suitable technique or techniques. At 410, the controller 204 of the computing device 100 can generate a GUI 300 showing at least one of a position, orientation, or trajectory of the instrument 130 relative to the plane 325 of the ultrasound image data, which is based on the ultrasound image data received from ultrasound imager 140, and a target zone that is registered with the one or more physiological landmarks identified at 406. The examiner notes that the trajectory is displayed in real time based on the position data of the needle); and
displaying on the display device a visual indication of the coordinates of the anatomical landmark (para. 0077; At 410, the controller 204 of the computing device 100 can generate a GUI 300 showing at least one of a position, orientation, or trajectory of the instrument 130 relative to the plane 325 of the ultrasound image data, which is based on the ultrasound image data received from ultrasound imager 140, and a target zone that is registered with the one or more physiological landmarks identified at 406.);
displaying on the display device a straight trajectory extending from the real-time visualization of the distal end of the needle to the visual indication of the coordinates of the anatomical landmark (paras. 0059 and 0077, At 410, the controller 204 of the computing device 100 can generate a GUI 300 showing at least one of a position, orientation, or trajectory of the instrument 130 relative to the plane 325 of the ultrasound image data, which is based on the ultrasound image data received from ultrasound imager 140, and a target zone that is registered with the one or more physiological landmarks identified at 406. The examiner notes that the system generates a trajectory for the instrument to travel from current position to the target point/landmark.);
calculating updated coordinates of the distal end of the needle based on an advancement of the distal end of the needle relative to the anatomical landmark (para. 0078; the controller 204 can be adapted to determine whether at least one of the position, orientation, or trajectory of the instrument 130 has changed. If yes, then the controller 204 can be adapted to generate an updated graphical user interface showing at least one of an updated position, orientation, or trajectory of the instrument. These steps may be performed interchangeably and/or concurrently and can be performed iteratively throughout the procedure.);
calculating updated coordinates of the anatomical landmark based on movement of the anatomical landmark (paras. 0072-0073; the controller 204 of the computing device 100 of system 10 can be adapted to also identify one or more physiological landmarks within the region of the patient and generate one or more markers, icons, or indicia in the GUI 300 that augments these one or more physiological landmarks so that the clinician can more readily identify them during the procedure. In one or more embodiments, the controller 204 is adapted to attach these markers to the physiological landmarks such that the markers are dynamic. In other words, the markers are attached to the physiological landmarks such that the markers move in registration with the landmarks in the GUI 300. Such registration of the markers with the physiological landmarks can aid the clinician in guiding the instrument 130 and/or one or more devices to the target region of the patient even though the patient or the region is moving in connection, e.g., with inhalation and exhalation and/or the beating of a heart of the patient.);
displaying on the display device an updated real-time visualization of the distal end of the needle in the coordinate system based on the updated coordinates of the distal end of the needle (para. 0078; the controller 204 can be adapted to determine whether at least one of the position, orientation, or trajectory of the instrument 130 has changed. If yes, then the controller 204 can be adapted to generate an updated graphical user interface showing at least one of an updated position, orientation, or trajectory of the instrument. These steps may be performed interchangeably and/or concurrently and can be performed iteratively throughout the procedure.);
displaying on the display device an updated visual indication of the coordinates of the anatomical landmark based on motion of the anatomical landmark (paras. 0072-0073 and 0077; the controller 204 of the computing device 100 of system 10 can be adapted to also identify one or more physiological landmarks within the region of the patient and generate one or more markers, icons, or indicia in the GUI 300 that augments these one or more physiological landmarks so that the clinician can more readily identify them during the procedure. In one or more embodiments, the controller 204 is adapted to attach these markers to the physiological landmarks such that the markers are dynamic. In other words, the markers are attached to the physiological landmarks such that the markers move in registration with the landmarks in the GUI 300. Such registration of the markers with the physiological landmarks can aid the clinician in guiding the instrument 130 and/or one or more devices to the target region of the patient even though the patient or the region is moving in connection, e.g., with inhalation and exhalation and/or the beating of a heart of the patient. At 410, the controller 204 of the computing device 100 can generate a GUI 300 showing at least one of a position, orientation, or trajectory of the instrument 130 relative to the plane 325 of the ultrasound image data, which is based on the ultrasound image data received from ultrasound imager 140, and a target zone that is registered with the one or more physiological landmarks identified at 406.); and
displaying on the display device an updated straight trajectory from the updated real-time visualization of the distal end of the needle to the updated visual indication of the coordinates of the anatomical landmark (paras. 0072-0073, 0078, and 0086; In one or more embodiments, the controller 204 is adapted to attach these markers to the physiological landmarks such that the markers are dynamic. In other words, the markers are attached to the physiological landmarks such that the markers move in registration with the landmarks in the GUI 300. Such registration of the markers with the physiological landmarks can aid the clinician in guiding the instrument 130 and/or one or more devices to the target region of the patient even though the patient or the region is moving in connection, e.g., with inhalation and exhalation and/or the beating of a heart of the patient. application 216 includes one or more machine learning algorithms to identify one or more physiological landmarks within the region of the patient and/or to provide an optimum trajectory for guiding a surgical instrument and/or medical device through a region of a patient based on data acquired during the procedure and/or data acquired prior to the procedure. The machine learning algorithms can also adjust the trajectory as the procedure advances. In one or more embodiments, the controller 204 can be adapted to determine whether at least one of the position, orientation, or trajectory of the instrument 130 has changed. If yes, then the controller 204 can be adapted to generate an updated graphical user interface showing at least one of an updated position, orientation, or trajectory of the instrument. The examiner notes that the processor determines a change in the location of a landmark due to inhalation, exhalation, or heart beats, and updates a graphical marker representing the landmark based on the updated location. The processor additionally, tracks the pose of the instrument in real time and updates the graphical representation of the pose of the instrument in real time. Additionally, the processor determines the optimal trajectory of the needle (Which is also displayed) to reach the identified treatment region based on data acquired during the procedure (which includes position data of the needle and the probe, and the location of the landmark). The machine learning algorithms can also adjust the trajectory as the procedure advances. Which means that the trajectory is also updated based on the location of the needle in real time, as it is advances).
Although Schotzko teaches tracking the anatomical landmark movement through registration, however, Schotzko fails to explicitly teach calculating coordinates of the anatomical landmark in the coordinate system using the location of the anatomical landmark and the location and orientation of the selection position of the imaging device; storing the coordinates of the anatomical landmark in memory associated with the processor; electrical signals indicative of motion of the anatomical landmark.
Washburn, in the same field of endeavor, teaches calculate coordinates of the anatomical landmark in the coordinate system using the location of the anatomical landmark and the location and orientation of the selection position of the imaging device (paras. 0025-0027 and 0029; A position sensor 134 is mounted on or within the probe 106. The position sensing module 130 tracks movements of the position sensor 134 within the spatial detection field, creating positional information within a reference coordinate system module 146. As points or structures are identified by the user, the image tracking module 124 uses positional information acquired by the position sensing module 130 to determine and store location information of the structures of interest within the reference coordinate system module 146. The examiner notes that the location (coordinates) of the landmark in the coordinate system is determined based on the location of the selected point and the position information of the ultrasound probe in the reference coordinate system.); store the coordinates of the anatomical landmark in memory associated with the processor (para. 0029; As points or structures are identified by the user, the image tracking module 124 uses positional information acquired by the position sensing module 130 to determine and store location information of the structures of interest within the reference coordinate system module 146.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the steps of determining the anatomical landmarks of Schotzko with the steps of determining the coordinates anatomical landmarks and storing them in the memory, as taught by Washburn, because such modification would eliminate the need to move the probe for visualizing the landmark and away from the needle as disclosed within Washburn in paras. 0068 and 0077. By using stored coordinated of anatomical landmark, the user can use the probe to visualize the needle insertion to the predefined anatomical landmarks.
However, Schotzko in the view of Washburn fail to teach electrical signals indicative of motion of the anatomical landmark.
Kozokaro, in the same field of endeavor, teaches an electrical location detection system configured to track movement of the heart over a breathing cycle (para. 0023; the sensor 5 includes at least six sensors formed as patches. In this embodiment, three of the sensors are attached to a patient's chest and three of the sensors are attached to a patient's back. In one aspect, the sensors 5 can be configured to measure inter-impedance among the sensors 5. These sensors 5 assist with modeling a patient's respiratory cycle, and identifying when a patient's lungs are breathing in or out. In one embodiment, when the lungs inflate or fill with air, then the impedance increases.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the motion compensation method of Schotzko in the view of Washburn with the motion compensation method used for modeling a patient's respiratory cycle of Kozokaro, because such modification would improve needle navigation because it would provide an accurate location of the needle and the anatomical landmark regardless of patient motion due to breathing.
Regarding claim 33, Schotzko the method of claim 29, further comprising displaying a linear trajectory between the location of the distal end of the needle and the coordinates of the anatomical landmark (paras. 0059 and 0077, At 410, the controller 204 of the computing device 100 can generate a GUI 300 showing at least one of a position, orientation, or trajectory of the instrument 130 relative to the plane 325 of the ultrasound image data, which is based on the ultrasound image data received from ultrasound imager 140, and a target zone that is registered with the one or more physiological landmarks identified at 406.).
Regarding claim 34, Schotzko teaches the method of claim 29, further comprising
adjusting the linear trajectory between the location of the distal end of the needle and the coordinates of the anatomical landmark based on movement of the heart during a breathing cycle (paras. 0072-0073, 0078, and 0086; In one or more embodiments, the controller 204 is adapted to attach these markers to the physiological landmarks such that the markers are dynamic. In other words, the markers are attached to the physiological landmarks such that the markers move in registration with the landmarks in the GUI 300. Such registration of the markers with the physiological landmarks can aid the clinician in guiding the instrument 130 and/or one or more devices to the target region of the patient even though the patient or the region is moving in connection, e.g., with inhalation and exhalation and/or the beating of a heart of the patient. application 216 includes one or more machine learning algorithms to identify one or more physiological landmarks within the region of the patient and/or to provide an optimum trajectory for guiding a surgical instrument and/or medical device through a region of a patient based on data acquired during the procedure and/or data acquired prior to the procedure. The machine learning algorithms can also adjust the trajectory as the procedure advances. In one or more embodiments, the controller 204 can be adapted to determine whether at least one of the position, orientation, or trajectory of the instrument 130 has changed. If yes, then the controller 204 can be adapted to generate an updated graphical user interface showing at least one of an updated position, orientation, or trajectory of the instrument. The examiner notes that the processor determines a change in the location of a landmark due to inhalation, exhalation, or heart beats, and updates a graphical marker representing the landmark based on the updated location. The processor additionally, tracks the pose of the instrument in real time and updates the graphical representation of the pose of the instrument in real time. Additionally, the processor determines the optimal trajectory of the needle (Which is also displayed) to reach the identified treatment region based on data acquired during the procedure (which includes position data of the needle and the probe, and the location of the landmark). The machine learning algorithms can also adjust the trajectory as the procedure advances. Which means that the trajectory is also updated based on the location of the needle in real time, as it is advances).
However, Schotzko in the view of Washburn fails to explicitly teach an electrical location detection system configured to track movement of the heart over a breathing cycle.
Kozokaro, in the same field of endeavor, teaches an electrical location detection system configured to track movement of the heart over a breathing cycle (para. 0023; the sensor 5 includes at least six sensors formed as patches. In this embodiment, three of the sensors are attached to a patient's chest and three of the sensors are attached to a patient's back. In one aspect, the sensors 5 can be configured to measure inter-impedance among the sensors 5. These sensors 5 assist with modeling a patient's respiratory cycle, and identifying when a patient's lungs are breathing in or out. In one embodiment, when the lungs inflate or fill with air, then the impedance increases.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the motion compensation method of Schotzko in the view of Washburn with the motion compensation method used for modeling a patient's respiratory cycle of Kozokaro, because such modification would improve needle navigation because it would provide an accurate location of the needle and the anatomical landmark regardless of patient motion due to breathing.
Regarding claim 35, Schotzko teaches the system of claim 34, however fails to explicitly teach wherein the electrical location detection system is based on impedance measured between patches positioned on a chest of the patient and patches positioned on a back of the patient.
Kozokaro, in the same field of endeavor, teaches wherein the electrical location detection system is based on impedance measured between patches positioned on a chest of the patient and patches positioned on a back of the patient (para. 0023; the sensor 5 includes at least six sensors formed as patches. In this embodiment, three of the sensors are attached to a patient's chest and three of the sensors are attached to a patient's back. In one aspect, the sensors 5 can be configured to measure inter-impedance among the sensors 5. These sensors 5 assist with modeling a patient's respiratory cycle, and identifying when a patient's lungs are breathing in or out. In one embodiment, when the lungs inflate or fill with air, then the impedance increases.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the motion compensation method of Schotzko in the view of Washburn with the motion compensation method used for modeling a patient's respiratory cycle of Kozokaro, because such modification would improve needle navigation because it would provide an accurate location of the needle and the anatomical landmark regardless of patient motion due to breathing.
Regarding claim 36, Schotzko the method of claim 29, wherein the imaging system is a handheld ultrasound probe (figure 1, para. 0042; Ultrasound imager 140, such as an ultrasound wand, may be used to image the patient's body during the procedure to visualize the location of the surgical instruments, such as instrument 130, inside the patient's body. The examiner notes that the ultrasound imager is an ultrasound handheld probe as shown in figure 1).
Regarding claim 37, Schotzko the method of claim 29, wherein the imaging system is a single-plane or bi-plane fluoroscopy imaging system (para. 0003; Image-guided medical and surgical procedures utilize patient images obtained prior to or during a medical procedure to guide a clinician performing the procedure. Recent advances in imaging technology, especially in imaging technologies that produce highly-detailed, two, three, and four-dimensional images, such as computed tomography (CT), magnetic resonance imaging (MRI), isocentric C-arm fluoroscopic imaging, positron emission tomography (PET), and ultrasound imaging (US), have heightened the interest in image-guided medical procedures. The examiner notes that Schotzko disclose that different imaging modalities can be used to image guide a procedure which includes fluoroscopic imaging).
Regarding claim 38, Schotzko the method of claim 29, wherein the anatomical landmark is the apex of the heart (para. 0084; physiological landmarks such as the mitral valve, IV septum, LV apex, aortic valve, etc., can be identified by the system 10 using any suitable technique).
Claim(s) 20-22 and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Schotzko et al. (US 2019/0307518) in the view of Washburn et al. (US 2008/0221446) and Kozokaro et al (US 2022/0142705) and in further view of Altmann et al (US 2006/0253032).
Regarding claim 20, Schotzko teaches the system of claim 19, wherein the position system is a magnetic based position system including a plurality of magnetic generators configured to generate magnetic fields in a predefined working volume and wherein the first position sensor and the second position sensor are a magnetic based position sensors configured to sense position and orientation based on sensing the magnetic fields generated by the plurality of magnetic coils (paras. 0041-0043; EM field generator 121 is used to generate an EM field during the procedure and forms part of an EM tracking system that is used to track the positions of one or more surgical instruments within the body of a patient. EM field generator 121 may include various components, such as a specially designed pad to be placed under, or integrated into, an operating table or patient bed. An example of such an EM tracking system is the AURORA™ system sold by Northern Digital Inc. While the present disclosure describes the use of system 10 in a surgical environment, it is also envisioned that some or all of the components of system 10 may be used in alternative settings, for example, an imaging laboratory and/or an office setting. Ultrasound imager 140 may have an EM tracking sensor embedded within or attached to the ultrasound wand, for example, a clip-on sensor, or a sticker sensor. An exemplary method of tracking the location of the instrument 130 includes using the EM tracking system, which tracks the location of the instrument by tracking sensors attached to or incorporated in the instrument. Various types of sensors may be used, such as a printed sensor).
However, Schotzko in the view of Washburn and Kozokaro fail to explicitly teach that the electromagnetic generator is an electromagnetic coil.
Altmann, in the same field of endeavor, teaches electromagnetic generator comprising an electromagnetic coil (para. 0140; The positioning sub-system typically comprises a set of external radiators, such as field generating coils 30, which are located in fixed, known positions external to the patient. Coils 30 generate fields, typically electromagnetic fields, in the vicinity of heart 24. The generated fields are sensed by a position sensor 32 inside catheter 28.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the electromagnetic generator of Schotzko in the view of Washburn and Kozokaro with the electromagnetic generating coil of Altmann, because such modification would have yielded predictable results to one of ordinary skilled in the art at the time of the invention.
Regarding claim 21, Schotzko teaches the system of claim 19, however, fails to explicitly teach wherein the processor is further configured to display on the display device an anatomical model of a chamber of the heart and to render the visual indication of the coordinates of the anatomical landmark on the anatomical model, wherein the anatomical model is computed based on input from the position system.
Altmann, in the same field of endeavor, teaches wherein the processor is further configured to display on the display device an anatomical model of a chamber of the heart and to render the visual indication of the coordinates of the anatomical landmark on the anatomical model, wherein the anatomical model is computed based on input from the position system (paras. 0027-0028; The image processor then constructs a 3-D structural model based on the multiple ultrasound images and the corresponding probe coordinates at which each of the images was captured, using the contours to segment the 3-D structures in the model. The 3-D coordinate of each point is calculated using the position sensor information and the 2-D ultrasound image properties. The calculated positions are used to construct the 3-D model. The contours tagged by the physician may be projected and displayed on top of the 3-D model. The examiner notes that the system generate an anatomical model based on ultrasound image data and position data).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the displayed image data of Schotzko in the view of Washburn and Kozokaro with the 3D model of Altmann, because such modification would improve needle navigation because anatomical model offers better visualization to the user and enable the user to view the entire anatomical structure in one display.
Regarding claim 22, Schotzko teaches the system of claim 21, however, fails to explicitly teach wherein the anatomical model is computed based on tracking location and orientation of a distal end of a catheter navigated within the chamber of the heart.
Altmann, in the same field of endeavor, teaches wherein the anatomical model is computed based on tracking location and orientation of a distal end of a catheter navigated within the chamber of the heart (paras. 0027-0028; The image processor then constructs a 3-D structural model based on the multiple ultrasound images and the corresponding probe coordinates at which each of the images was captured, using the contours to segment the 3-D structures in the model. The 3-D coordinate of each point is calculated using the position sensor information and the 2-D ultrasound image properties. The calculated positions are used to construct the 3-D model. The contours tagged by the physician may be projected and displayed on top of the 3-D model. The examiner notes that the system generate an anatomical model based on ultrasound image data and position data of the catheter).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the displayed image data of Schotzko in the view of Washburn and Kozokaro with the 3D model of Altmann, because such modification would improve needle navigation because anatomical model offers better visualization to the user and enable the user to view the entire anatomical structure in one display.
Regarding claim 30, Schotzko teaches the method of claim 29, wherein the position system is a magnetic based position system including a plurality of magnetic generators configured to generate magnetic fields in a predefined working volume and wherein each of the imaging device and the distal end of the needle includes a magnetic based position sensor configured to sense its position and orientation based on sensing the magnetic fields generated by the plurality of magnetic coils (paras. 0041-0043; EM field generator 121 is used to generate an EM field during the procedure and forms part of an EM tracking system that is used to track the positions of one or more surgical instruments within the body of a patient. EM field generator 121 may include various components, such as a specially designed pad to be placed under, or integrated into, an operating table or patient bed. An example of such an EM tracking system is the AURORA™ system sold by Northern Digital Inc. While the present disclosure describes the use of system 10 in a surgical environment, it is also envisioned that some or all of the components of system 10 may be used in alternative settings, for example, an imaging laboratory and/or an office setting. Ultrasound imager 140 may have an EM tracking sensor embedded within or attached to the ultrasound wand, for example, a clip-on sensor, or a sticker sensor. An exemplary method of tracking the location of the instrument 130 includes using the EM tracking system, which tracks the location of the instrument by tracking sensors attached to or incorporated in the instrument. Various types of sensors may be used, such as a printed sensor).
However, Schotzko in the view of Washburn and Kozokaro fail to explicitly teach that the electromagnetic generator is an electromagnetic coil.
Altmann, in the same field of endeavor, teaches electromagnetic generator comprising an electromagnetic coil (para. 0140; The positioning sub-system typically comprises a set of external radiators, such as field generating coils 30, which are located in fixed, known positions external to the patient. Coils 30 generate fields, typically electromagnetic fields, in the vicinity of heart 24. The generated fields are sensed by a position sensor 32 inside catheter 28.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the electromagnetic generator of Schotzko in the view of Washburn and Kozokaro with the electromagnetic generating coil of Altmann, because such modification would have yielded predictable results to one of ordinary skilled in the art at the time of the invention.
Regarding claim 31, Schotzko teaches the method of claim 29, however, fails to explicitly teach displaying on the display device the heart during the subsequent needle insertion step; and marking the visual indication of the coordinates of the anatomical landmark on the image (paras. 0075-0077; At 402, ultrasound image data can be received from the ultrasound sensor or imager 140 by the computing device 100. The ultrasound image data may be relayed from ultrasound workstation 150. Next, or concurrently with step 402, computing device 100 receives EM tracking data from the EM tracking system for ultrasound imager 140 and the instrument 130 at 404. The EM tracking data is representative of positions and orientations of each of the ultrasound sensor and the instrument 130 relative to the region of the patient. At 406, one or more physiological landmarks based on the ultrasound image data can be identified either by the clinician or the controller 204 using any suitable technique or techniques.).
However, Schotzko in the view of Washburn and Kozokaro fails to explicitly teach that the images are an anatomical model of the heart.
Altmann, in the same field of endeavor, teaches displaying on the display device an anatomical model of the heart; and marking the visual indication of the coordinates of the anatomical landmark on the anatomical model (paras. 0027-0028; The image processor then constructs a 3-D structural model based on the multiple ultrasound images and the corresponding probe coordinates at which each of the images was captured, using the contours to segment the 3-D structures in the model. The 3-D coordinate of each point is calculated using the position sensor information and the 2-D ultrasound image properties. The calculated positions are used to construct the 3-D model. The contours tagged by the physician may be projected and displayed on top of the 3-D model. The examiner notes that the system generate an anatomical model based on ultrasound image data and position data).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the displayed image data of Schotzko in the view of Washburn and Kozokaro with the 3D model of Altmann, because such modification would improve needle navigation because anatomical model offers better visualization to the user and enable the user to view the entire anatomical structure in one display.
Regarding claim 32, Schotzko teaches the method of claim 31, tracking location and orientation of a distal end of a catheter navigated within the chamber of the heart with the position system (para. 0043; An exemplary method of tracking the location of the instrument 130 includes using the EM tracking system, which tracks the location of the instrument by tracking sensors attached to or incorporated in the instrument.)
However, Schotzko in the view of Washburn and Kozokaro fail to explicitly teach computing with the processor, the anatomical model based on the tracking of the distal end of the catheter.
Altmann, in the same field of endeavor, teaches computing with the processor, the anatomical model based on the tracking of the distal end of the catheter (paras. 0027-0028; The image processor then constructs a 3-D structural model based on the multiple ultrasound images and the corresponding probe coordinates at which each of the images was captured, using the contours to segment the 3-D structures in the model. The 3-D coordinate of each point is calculated using the position sensor information and the 2-D ultrasound image properties. The calculated positions are used to construct the 3-D model. The contours tagged by the physician may be projected and displayed on top of the 3-D model. The examiner notes that the system generate an anatomical model based on ultrasound image data and position data of the catheter).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the displayed image data of Schotzko in the view of Washburn and Kozokaro with the 3D model of Altmann, because such modification would improve needle navigation because anatomical model offers better visualization to the user and enable the user to view the entire anatomical structure in one display.
Response to Arguments
Applicant's arguments filed 07/02/2026 have been fully considered but they are not persuasive. The applicant argues that Schotzko fails to teach or suggest updating on a display a trajectory between the distal end of the needle and a marked anatomical location based on both the location of the distal end and the marked anatomical location. The examiner respectfully disagrees. Schotzko teaches acquiring data during a procedure which includes image data and position data of the imaging probe and the needle. Using the imaging data, the system identifies one or more anatomical landmarks within the region of the patient and generates one or more markers, icons, and indicia in the GUI that augments these one or more physiological landmarks so that the clinician can more readily identify them during the procedure. The controller is adapted to attach these markers to the physiological landmarks such that the markers are dynamic. In other words, the markers are attached to the physiological landmarks such that the markers move in registration with the landmarks in the GUI. Such registration of the markers with the physiological landmarks can aid the clinician in guiding the instrument and/or one or more devices to the target region of the patient even though the patient or the region is moving in connection, e.g., with inhalation and exhalation and/or the beating of a heart of the patient. Based on the identified one or more physiological landmarks within the region of the patient, the system provides an optimum trajectory for guiding a surgical instrument and/or medical device through a region of a patient based on data acquired during the procedure. Furthermore, the system adjusts the trajectory as the procedure advances. Then the system determines based on position data of the needle, if the position or orientation of the needle has changed and update the graphical user interface to show the updated position, orientation, and trajectory based on the updated position information. Thus, Schotzko teaches generating an a trajectory/path from the current pose of the needle to the target region to aid in guiding the needle to the target region. Schotzko teaches that the GUI updates the marker location of the landmark based on movement of the landmark due to inhalation and exhalation and/or the beating of a heart of the patient and updates the marker of the needle showing the position/orientation of the needle based on sensed changes in the pose of the needle. Additionally, Schotzko disclose that the trajectory gets updated as the needle is advanced which means based on the position data of the needle and displaying an optimum trajectory guiding the instrument to the target region. Thus, if the region of interest changes or the position of the needle changes, the trajectory guiding the needle to the ROI is necessarily updated to guide the needle from its current location to the location of the target region. Therefore, Schotzko teaches updating the trajectory based on the location data of the landmark and the needle to facilitate guiding the needle to the target region.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yarmush et al. US 2021/0378627, Ultrasound-Guided Alignment And Insertion Of Percutaneous Cannulating Instruments. Yarmush teaches the processor receives imaging data from the imaging probe, cannula pose data from at least one cannula position sensor, and device pose data from at least one device position sensor. The target location is identified from the imaging data, and a trajectory for manipulating the cannula towards the target location is determined based on the imaging data, the cannula pose data, and the device pose data. The processor may determine that the trajectory becomes misaligned with the target position, and may update to a corrected trajectory based on the imaging data, cannula pose data, and the device pose data.
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 ZAINAB M ALDARRAJI whose telephone number is (571)272-8726. The examiner can normally be reached Monday-Thursday7AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carey Michael can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797
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