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 .
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
STATUS OF CLAIMS AND REJECTIONS
Claim 12 has been cancelled.
Claims 1-11 and 13-29 are pending.
Claims 1, 2, 4-6, 8, 10, 13-15, and 17 have been amended. Claim 29 is newly added.
Claims 18-28 are withdrawn.
In light of the claim amendments, the Section 112(f) interpretation for “tracker” has been withdrawn.
In light of the claim amendments, the Section 112(b) rejections of claim 2, 5, 10, and 17 have been withdrawn.
In light of the claim amendments, the Section 101 rejection of claims 1-17 have been withdrawn.
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, 4-11, 13-17, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2009/0198298 (hereinafter “KAISER”) and U.S. Patent Appl. Publ. No. 2009/0182224 A1 (hereinafter “SHMARAK”) and U.S. Patent Appl. Publ. No. 2004/0176681 A1 (hereinafter “MAO”).
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With respect to claim 1, KAISER teaches method and system for use in selecting a cardiac pacing site includes sensors for tracking wall motion (e.g., sensors coupled to the right and left ventricular heart wall). (Abstract). Figure 1 is a diagram of an image guided catheter navigation system 10 that may be used to navigate catheters, or leads, within the body. ([0014]).
KAISER teaches a system. “By time-gating the image data and/or the navigation data, the location of the catheter 52 relative to the heart at the same point in the cardiac cycle may be displayed on the display 36.” (Abstract). The KAISER system includes:
a catheter (electromagnetic catheter 52, [0018]) positioned in an anatomical element (Abstract, see also Figure 1 showing catheter 52 positioned within the patient 14);
a tracker comprising a sensor coupled with the catheter that detects movement of the catheter (electromagnetic navigation or tracking system 44 includes the catheter 52 having sensors 58 [i.e., trackers] in which “electromagnetic fields generated in the patient space induce currents in sensors 58 (e.g., sensing coils) positioned in the catheter 52 (or sensors positioned in each of multiple leads).” ([0021]));
a processor ([0011]); and
a memory storing data for processing by the processor. ([0011]: “a system, method, or computer readable medium (e.g., including one or more programs including one or more instructions executable by a computer) described herein may simplify intra-operative monitoring of the mechanical response of the heart to pacing at various sites.”).
KAISER also teaches that the data, when processed, causes the processor to:
track, based on sensor data generated by the sensor, a pose of the catheter (“The dynamic reference frame 54 may be a small magnetic field detector that is designed to be fixed to the patient 14 adjacent to the region being navigated so that any movement of the patient 14 is detected as relative motion between the transmitter coil array 46 and the dynamic reference frame 54. This relative motion is forwarded to the coil array controller 48, which updates registration correlation and maintains accurate navigation.” (emphasis added) [0025])) as the anatomical element progresses through two or more cyclic phases of motion to yield a plurality of pose information (“The navigation system 10 may be able to detect the position of the patient's anatomy and the position of the catheter 52 (e.g., the sensor coupled to the heart wall) or other surgical instrument, or data related thereto. Data related to the positions of these two items may be used to allow the navigation system 10 to compute and display the position of the catheter 52 in relation to the patient 14.” (emphasis added) ([0028]); see also [0029]).
With respect to the remaining claim limitations, KAISER does not explicitly teach determining the two or more cyclic phases of motion of the anatomical element based on the plurality of pose information; determining, from the two or more cyclic phases of motion, a target phase at which the anatomical element has less movement relative to the other phases in the two or more cyclic phases of motion; and synchronizing an imaging device with the plurality of pose information to capture an image of the anatomical element at the target phase of the two or more cyclic phases of motion. However, KAISER is clearly concerned with viewing the catheter and the anatomical tissue at the same point during the cardiac cycles to avoid motion artifacts. “By time-gating the image data and/or the navigation data, the location of the catheter 52 relative to the heart at the same point in the cardiac cycle may be displayed on the display 36.” (emphasis added) ([0026]; see also [0028]).
In the same field of endeavor, SHMARAK teaches an apparatus for generating an organ timing signal relating to an inspected organ within the body of a patient. (Abstract). SHMARAK teaches a technique “for monitoring organ phases in three-dimensional medical imaging and navigation, in particular.” ([0001]). “In instances of imaging of anatomical structures that involve periodic motion or cyclic phases, the imaging system may encompass a timing element to take this into account.” ([0002]). SHMARAK notes that ECG machines are often used but have a few drawbacks. (Id). “Typically, the timing information obtained from such monitoring devices is not completely accurate. As well, the signal received from such monitoring devices involves a delay, and is not obtained in real-time with respect to the actual organ motion. Finally, an external monitoring device adds a cumbersome element to an already complex system.” (Id).
SHMARAK’s system addresses these disadvantages and “allows for image acquisition and playback, three-dimensional model reconstruction, intra-body navigation, and tracking an invasive device during minimally invasive surgery.” ([0027]). SHMARAK’s apparatus uses a medical positioning system (MPS) 102 having a plurality of MPS sensors 1201, 1202, 1203, 1204 that “contain electromagnetic field detection elements, such as coils.” ([0031], see also [0029]). In one example, the inspected organ is a heart in which the “phase information may be heart timing signals denoting stages within a cardiac cycle. A cardiac cycle is defined as the time between two subsequent heart contractions. The electrical activity of the heart as a function of time, such as electrical timing signals obtained by an ECG monitor, can reveal the current stage or phase of the heart within the cardiac cycle.” ([0037]).
SHMARAK teaches using MPS data sets (i.e., position coordinates) obtained from the MPS sensors to determine one or more phases of motion of the heart. ([0052]). One sensor is attached to the surgical tool. “MPS sensor 1201 is attached to surgical tool 124.” Phase information of the heart can be derived from this sensor. “Processor 108 obtains phase information by processing data provided by MPS 102 via MPS sensor 1201, without the need for any external monitoring device (such as an ECG device). Other sensors may be used independently or in addition in order to generate phase information (e.g., MPS sensor 1203 in conjunction with MPS sensor 1201).” ([0037]).
Figure 6 of SHMARAK illustrates how the system can capture a series of images in which each image occurs at the same phase or activity-state. “For example, processor 108 associates for a given two-dimensional image acquired during activity-state T1, all the position coordinate readings of surgical tool 124 (i.e., coordinates 612, 618 and 624) which were detected during activity-state T1 at any cycle of cardiac trajectory 400.” ([0073]).
Accordingly, SHMARAK teaches:
determining the two or more cyclic phases of motion of the anatomical element based on the plurality of pose information. As shown in Figure 6, the SHMARAK system can discern between different phases of motion (based on data from the surgical tool’s sensor). Phase
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T1 is associated with position coordinates 612, 618, 624; phase T2 is associated with position coordinates 614, 620, 626; and phase T3 is associated with position coordinates 616, 622, 628.
determining, from the two or more cyclic phases of motion, a target phase in the two or more cyclic phases of motion. While SHMARK does not explicitly teach determining the phase at which there is less movement, SHMARAK clearly teaches distinguishing the different phases such that the images may be tagged for each phase. “Display 110 may present an image frame showing the position of surgical tool 124, respective of the inspected organ at a given activity-state, in accordance with acquired two-dimensional image data, acquired MPS data, and associated activity-state information.” ([0084]).
It would have been obvious to one skilled in the art to use SHMARAK’s method to determine two or more cyclic phases of motion of the anatomical element based on the plurality of pose information and a target phase of the two cyclic phases. KAISER uses ECG signals for time-gating image acquisition. One would have been motivated to add SHMARAK’s method using electromagnetic sensors (i.e., position sensors) to detect the different phases of the cardiac cycle because of the potential drawbacks of the ECG method alone. Moreover, one would have motivated to select a target phase, as taught in SHMARAK, because KAISER suggests being able to view the catheter at the same phase of a cardiac cycle. (see, e.g., [0026] of KAISER). There would have been a reasonable expectation of success as SHMARAK demonstrates that the phases of the cardiac cycle can be detected using position sensors.
SHMARAK also teaches:
display the image. “Display 110 may present an image frame showing the position of surgical tool 124, respective of the inspected organ at a given activity-state, in accordance with acquired two-dimensional image data, acquired MPS data, and associated activity-state information.” ([0084]; see also Figure 6).
update, based on the image, a multi-dimensional model of the anatomical element. “Processor 108 may further construct a three-dimensional image from captured two-dimensional images having the same activity-state, and from three-dimensional position data associated with each of the images.” ([0043]; see also [0044]: “The motion picture may consist of a projection of a constructed three-dimensional model of the organ.”).
It would have been obvious to one skilled in the art to display the image and updated, based on the image, a multi-dimensional model of the anatomical element as taught in SHMARAK. One would have been motivated to display the image to a surgeon as images often help the surgeon navigate the catheter or other surgical device. One would have been motivated to update a three-dimensional model of the heart for the same reason (i.e., to provide a more updated version of the model to the surgeon). There would have been a reasonable expectation of success as SHMARAK demonstrates that images and models can be presented to a user.
While neither SHMARK nor KAISER explicitly teach determining, from the two or more cyclic phases of motion, a target phase at which the anatomical element has less movement relative to the other phases, KAISER is clearly concerned with being able to image or view the anatomy at a particular phase. “By time-gating the image data and/or the navigation data, the location of the catheter 52 relative to the heart at the same point in the cardiac cycle may be displayed on the display 36.” (emphasis added) ([0026] of KAISER; see also [0028]).
While neither SHMARK nor KAISER explicitly teach synchronizing an imaging device with the plurality of pose information to capture an image of the anatomical element at the target phase of the two or more cyclic phases of motion (i.e., prospective-gating capture), SHMARK teaches assigning images their respective phases or activity-states. “In procedure 908, correlated phase information is obtained for the two-dimensional images data set. The phase information is correlated in the sense that the phase information is not obtained directly from the images but from correlated MPS data (occurring at the same time as a given image). The phases or activity-states of the heart, such as activity-states T1, T2 and T3 with reference to FIG. 4, during which each two-dimensional image was acquired, is identified.” ([0095]). SHMARAK teaches then displaying a motion picture for the particular activity-state. “Display 110 presents a motion picture, or image sequence, of the inspected organ in real-time…The motion picture displays the trajectory of surgical tool 120 as the surgical tool is guided within the patient body, respective of different activity-states of an inspected organ.” ([0044]).
In the same field of endeavor, MAO teaches “a method and apparatus for acquiring cardiac images having minimized motion artifact by triggering an image-acquisition scan at a point during the quiescent segment of each cardiac cycle.” (Abstract). “[I]t is an object of the present invention to provide a method and apparatus for acquiring diagnostically valuable cardiac images of the heart having minimized motion artifact via prospective gating by triggering an image-acquisition scan starting at a point of a cardiac cycle, where this point is calculated, in part, by the length of the cardiac cycle.” ([0010]).
MAO specifically teaches that “[a]cquiring clear images of the heart is typically impeded by cardiac motion and coronary artery motion caused by the rhythmic beating of the heart. The resulting loss of resolution causes blurring or streaking, called motion artifact, which diminishes the diagnostic value of these images.” ([0002]). Moreover, “[e]fforts have been made to minimize cardiac motion artifact.” ([0003]). The heart has minimized motion at “quiescent points.” ([0006]). However, “[q]uiescent points, however, vary with heart rate, so that using a fixed percentage for all subjects regardless of heart rate is ineffective.” ([0007]). “The quiescent segment, which corresponds to the period of minimized cardiac motion velocity, is late systole to early diastole, and approximates the end of the R-T segment.” ([0013]). When the quiescent phase is determined, an imaging apparatus may be synchronized to acquire images at that target phase. “This gating device synchronizes the triggering of image-acquisition scans with specific points of the cardiac cycle.” ([0015]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the KAISER system to determine a target phase from a plurality of target phases at which the anatomical element has less movement relative to the other phases and synchronize an imaging device with the plurality of pose information to capture an image of the anatomical element at the target phase of the two or more cyclic phases of motion, as taught in MAO. While MAO concerns ECG gating, the ideal time for acquiring images is the same (i.e., minimized motion). Based on the teachings of SHMARAK and MAO, one would have been motivated to identify a target phase (quiescent phase) and then synchronize an imaging apparatus to prospectively capture images at the target phase because to provide real-time (or nearly real-time) images of the catheter at the same activity-state. Prospective synchronization would reduce the number of images captured and reduce time for processing. There would have been a reasonable expectation of success as MAO teaches that imaging apparatuses can be synchronized to acquire images at certain times.
With respect to claim 2, KAISER teaches that wherein the sensor data further comprises information associated with velocity of the catheter. “For example, the catheter probe may be positioned on the endocardial surface and/or epicardial surface, and used to measure wall motion (e.g., location of the sensing coil positioned on the wall) over one or more cardiac cycles. In other words, changes in wall motion may be measured at the site of the sensing coil affixed to the catheter probe (e.g., either when the heart is not being paced or while altering pacing locations within and/or outside the RV, LV, or both).” ([0040]; see also subsequent paragraph [0041], explaining that lead placement may be selected by maximizing “the velocity of such wall motion….”).
With respect to claim 4, KAISER does not explicitly teach wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive bio-electric signals, wherein determining the two or more cyclic phases of motion is further based on the bio-electric signals. (emphasis added). However, KAISER does teach using ECG to determine a triggering event. ([0026]).
In the same field of endeavor, SHMARAK teaches using MPS data sets in addition to ECG data. “A monitoring device such as an ECG may be used in conjunction with MPS data to obtain phase information of the two-dimensional image data set in certain instances.” ([0096]; see also [0040] and [0106]).
It would have been obvious to one skilled in the art to use SHMARAK’s method to determine one or more phases of motion of the heart using the pose information and bio-electric signals (i.e., ECG). One would have been motivated to use SHMARAK’s method using electromagnetic sensors (i.e., position sensors) to detect the different phases of the cardiac cycle in addition to ECG data because of the potential drawbacks of the ECG method alone. Using ECG data provides another means to the confirm the phases of the cardiac cycle. There would have been a reasonable expectation of success as SHMARAK demonstrates that the phases of the cardiac cycle can be detected using position sensors and ECG data.
With respect to claim 5 (and in light of the Section 112(b) rejection), KAISER does not explicitly teach wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive respiratory cycle signals, wherein determining the two or more cyclic phases of motion is further based on the respiratory cycle signals.
However, in the same field of endeavor, SHMARAK teaches that the motion of a surgical tool is caused by cardiac motion and respiratory motion. “Cardiac motion affects the vessel in a certain way, such as contraction or expansion in varying degrees and at periodic intervals. The second factor relates to breathing activity, or respiratory motion, such as inhaling and exhaling. Respiratory motion affects the vessel in a certain way, such as contraction or expansion in varying degrees and at periodic intervals.” ([0054]). Accordingly, SHMARAK receives respiratory cycle signals to determine respiratory motion’s effect. “Reconstruction of the respiratory trajectory may be based solely on coordinate readings obtained from the external reference sensors (i.e., MPS sensors 120.sub.3 or 120.sub.4). It is noted that an additional reference sensor (or plurality thereof) may be attached (i.e., externally or internally) to the body of the patient, to monitor breathing patterns and the like.” ([0059]). Moreover, the data used to determine respiratory motion can be used to confirm cardiac phases. “It is noted that periodic motion components relating to the respiratory motion may also be used as supporting data for cardiac phase detection.” ([0062]; see also [0086]).
It would have been obvious to one skilled in the art to receive respiratory cycle signals to determine the one or more phases of motion. One would have been motivated to receive the respiratory cycle signals in order to determine how respiratory motion may affect motion of the surgical tool (e.g., catheter) within the heart. There would have been a reasonable expectation of success because, as taught in SHMARAK, respiratory motion can be determined using data from electromagnetic sensors.
With respect to claim 6, KAISER teaches wherein the anatomical element comprises a heart and the one or more phases correspond to two or more cyclic phases of the heartbeat. “By time-gating the image data and/or the navigation data, the location of the catheter 52 relative to the heart at the same point in the cardiac cycle may be displayed on the display 36.” (emphasis added) ([0026]; see also [0028]).
With respect to claim 7 (depending on claim 6), KAISER teaches wherein the two or more cyclic phases of the heartbeat comprise at least a diastole motion and a systole motion. “By time-gating the image data and/or the navigation data, the location of the catheter 52 relative to the heart at the same point in the cardiac cycle may be displayed on the display 36.” (emphasis added) ([0026]; see also [0028]). This is confirmed by MAO, which teaches that the target phase can occur during diastole motion or systole motion. “The quiescent segment, which corresponds to the period of minimized cardiac motion velocity, is late systole to early diastole, and approximates the end of the R-T segment.” ([0013]).
With respect to claim 8, KAISER teaches wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: average the sensor data for a plurality of target phases of a plurality of cyclic phases of motion; and apply the average to subsequent tracking at the target phase. “According to one exemplary method, heart wall motion data sets, for example, are averaged over multiple (e.g., five) heart beats, for the non-paced condition and each of the paced conditions that correspond to each pair of selected pacing sites, may be collected and stored for projection onto a pre-acquired image of the patient's heart… Each of these wall motion data sets, which are presented by the motion of the virtual representation of sensor coil 258R on the pre-acquired image, may then be viewed, for example, on display 36 of workstation 34 (FIG. 1) ...” ([0037]).
With respect to claim 9, KAISER teaches wherein the memory stores further data for processing by the processor that, when processed, causes the processor to determine a patient state based on the motion of the anatomical element. “[I]n one or more embodiments, the methods or systems use pre-programmed algorithms (e.g., executable and/or stored by workstation 34) to process wall motion data (e.g., wall motion data collected from coils 258R, 258L) to generate image data or any other type of notification information or data (e.g., data used to notify a user) that can assist a physician in selecting one or more effective pacing sites. For example, such image data may assist such selection by facilitating a methodical comparison between baseline non-paced mechanical function of the heart and the mechanical function thereof in response to pacing at one or more sites (e.g., bi-ventricular pacing).” (emphasis added). Examiner is interpreting “determine a patient state based on the motion of the anatomical element” as including processing wall motion data to display information relating to a baseline non-paced mechanical function of the heart or to display information relating to the mechanical function in response to pacing at one or more sites. Either is a patient state.
With respect to claim 10, KAISER teaches wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: determine, based on the sensor data, a velocity of the catheter as the anatomical element progresses through the two or more cyclic phases of motion; and determine an environmental state of the catheter based on the velocity of the catheter. “For example, the catheter probe may be positioned on the endocardial surface and/or epicardial surface, and used to measure wall motion (e.g., location of the sensing coil positioned on the wall) over one or more cardiac cycles. In other words, changes in wall motion may be measured at the site of the sensing coil affixed to the catheter probe (e.g., either when the heart is not being paced or while altering pacing locations within and/or outside the RV, LV, or both).” ([0040]; see also subsequent paragraph [0041], explaining that lead placement may be selected by maximizing “the velocity of such wall motion….”). KAISER also teaches executing a program to process wall motion data, such as determining a wall velocity. “[T]he methods or systems use pre-programmed algorithms (e.g., executable and/or stored by workstation 34) to process wall motion data (e.g., wall motion data collected from coils 258R, 258L) to generate image data or any other type of notification information or data (e.g., data used to notify a user) that can assist a physician in selecting one or more effective pacing sites.” ([0042]). “[I]mage data may be generated such that a user may select a pacing site based on maximizing wall motion (or the derivable quantities thereof, such as velocity, acceleration, or strain), based on minimizing the difference between time to peak wall motion or velocity (e.g., synchronization characteristics), or based on a combination thereof.” ([0047]). “Optimization of cardiac mechanical activation during pacing lead placement may include selecting lead placement by maximizing the magnitude of wall motion and/or the timing of wall motion, the velocity of such wall motion, or the acceleration of such wall motion, such as during isovolumic contraction and/or relaxation, or such as during systole and/or diastole. Still further, for example, optimization of cardiac mechanical activation during acute pacing lead placement may include minimizing differences in wall motion magnitude and/or the timing of wall motion, the velocity of such wall motion, or the acceleration of such wall motion, such as during isovolumic contract and/or relaxation, or such as during systole and/or diastole.” ([0041]).
Notably, KAISER teaches notifying the user that a pacing site is an optimal or non-optimal pacing site. (see, e.g., claim 10: “generating notification data indicative of the one or more first pacing sites being one of an optimal pacing site and a non-optimal pacing site.”). Examiner is interpreting “determine an environmental state of the catheter” as determining a pacing site with maximum wall motion, which may be one of the optimal pacing sites.
With respect to claim 11, KAISER teaches wherein the tracker comprises at least one of an inertial measurement unit tracker, an electromagnetic tracker, or a combination of the inertial measurement unit tracker and the electromagnetic tracker. “The catheter 52, may be equipped with at least one, and generally multiple sensors 58 (e.g., electromagnetic sensing coils).” (emphasis added) ([0023]).
With respect to claim 13, KAISER teaches method and system for use in selecting a cardiac pacing site includes sensors for tracking wall motion (e.g., sensors coupled to the right and left ventricular heart wall). (Abstract). Figure 1 is a diagram of an image guided catheter navigation system 10 that may be used to navigate catheters, or leads, within the body. ([0014]).
KAISER teaches a system. “By time-gating the image data and/or the navigation data, the location of the catheter 52 relative to the heart at the same point in the cardiac cycle may be displayed on the display 36.” (Abstract). The KAISER system includes:
a catheter (electromagnetic catheter 52, [0018]) positioned in an anatomical element (Abstract, see also Figure 1 showing catheter 52 positioned within the patient 14);
a tracker comprising a sensor coupled with the catheter that detects movement of the catheter (electromagnetic navigation or tracking system 44 includes the catheter 52 having sensors 58 [i.e., trackers] in which “electromagnetic fields generated in the patient space induce currents in sensors 58 (e.g., sensing coils) positioned in the catheter 52 (or sensors positioned in each of multiple leads).” ([0021]));
a processor ([0011]); and
a memory storing data for processing by the processor. ([0011]: “a system, method, or computer readable medium (e.g., including one or more programs including one or more instructions executable by a computer) described herein may simplify intra-operative monitoring of the mechanical response of the heart to pacing at various sites.”).
KAISER also teaches that the data, when processed, causes the processor to:
track, based on sensor data generated by the sensor, a pose of the catheter (“The dynamic reference frame 54 may be a small magnetic field detector that is designed to be fixed to the patient 14 adjacent to the region being navigated so that any movement of the patient 14 is detected as relative motion between the transmitter coil array 46 and the dynamic reference frame 54. This relative motion is forwarded to the coil array controller 48, which updates registration correlation and maintains accurate navigation.” (emphasis added) [0025])) as the anatomical element progresses through two or more cyclic phases of motion to yield a plurality of pose information (“The navigation system 10 may be able to detect the position of the patient's anatomy and the position of the catheter 52 (e.g., the sensor coupled to the heart wall) or other surgical instrument, or data related thereto. Data related to the positions of these two items may be used to allow the navigation system 10 to compute and display the position of the catheter 52 in relation to the patient 14.” (emphasis added) ([0028]); see also [0029]).
With respect to the remaining claim limitations, KAISER does not explicitly teach determining the two or more cyclic phases of motion of the anatomical element based on the plurality of pose information; determining, from the two or more cyclic phases of motion, a target phase at which the anatomical element has less movement relative to the other phases in the two or more cyclic phases of motion; and synchronizing an imaging device with the plurality of pose information to capture an image of the anatomical element at the target phase of the two or more cyclic phases of motion. However, KAISER is clearly concerned with viewing the catheter and the anatomical tissue at the same point during the cardiac cycles to avoid motion artifacts. “By time-gating the image data and/or the navigation data, the location of the catheter 52 relative to the heart at the same point in the cardiac cycle may be displayed on the display 36.” (emphasis added) ([0026]; see also [0028]).
In the same field of endeavor, SHMARAK teaches an apparatus for generating an organ timing signal relating to an inspected organ within the body of a patient. (Abstract). SHMARAK teaches a technique “for monitoring organ phases in three-dimensional medical imaging and navigation, in particular.” ([0001]). “In instances of imaging of anatomical structures that involve periodic motion or cyclic phases, the imaging system may encompass a timing element to take this into account.” ([0002]). SHMARAK notes that ECG machines are often used but have a few drawbacks. (Id). “Typically, the timing information obtained from such monitoring devices is not completely accurate. As well, the signal received from such monitoring devices involves a delay, and is not obtained in real-time with respect to the actual organ motion. Finally, an external monitoring device adds a cumbersome element to an already complex system.” (Id).
SHMARAK’s system addresses these disadvantages and “allows for image acquisition and playback, three-dimensional model reconstruction, intra-body navigation, and tracking an invasive device during minimally invasive surgery.” ([0027]). SHMARAK’s apparatus uses a medical positioning system (MPS) 102 having a plurality of MPS sensors 1201, 1202, 1203, 1204 that “contain electromagnetic field detection elements, such as coils.” ([0031], see also [0029]). In one example, the inspected organ is a heart in which the “phase information may be heart timing signals denoting stages within a cardiac cycle. A cardiac cycle is defined as the time between two subsequent heart contractions. The electrical activity of the heart as a function of time, such as electrical timing signals obtained by an ECG monitor, can reveal the current stage or phase of the heart within the cardiac cycle.” ([0037]).
SHMARAK teaches using MPS data sets (i.e., position coordinates) obtained from the MPS sensors to determine one or more phases of motion of the heart. ([0052]). One sensor is attached to the surgical tool. “MPS sensor 1201 is attached to surgical tool 124.” Phase information of the heart can be derived from this sensor. “Processor 108 obtains phase information by processing data provided by MPS 102 via MPS sensor 1201, without the need for any external monitoring device (such as an ECG device). Other sensors may be used independently or in addition in order to generate phase information (e.g., MPS sensor 1203 in conjunction with MPS sensor 1201).” ([0037]).
Figure 6 of SHMARAK illustrates how the system can capture a series of images in which each image occurs at the same phase or activity-state. “For example, processor 108 associates for a given two-dimensional image acquired during activity-state T1, all the position coordinate readings of surgical tool 124 (i.e., coordinates 612, 618 and 624) which were detected during activity-state T1 at any cycle of cardiac trajectory 400.” ([0073]).
Accordingly, SHMARAK teaches:
determine the two or more cyclic phases of motion of the anatomical element based on the plurality of pose information. As shown in Figure 6, the SHMARAK system can discern between different phases of motion (based on data from the surgical tool’s sensor). Phase T1 is associated with position coordinates 612, 618, 624; phase T2 is associated with position coordinates 614, 620, 626; and phase T3 is associated with position coordinates 616, 622, 628.
determine, from the two or more cyclic phases of motion, a target phase in the two or more cyclic phases of motion. While SHMARK does not explicitly teach determining the phase at which there is less movement, SHMARAK clearly teaches distinguishing the different phases such that the images may be tagged for each phase. “Display 110 may present an image frame showing the position of surgical tool 124, respective of the inspected organ at a given activity-state, in accordance with acquired two-dimensional image data, acquired MPS data, and associated activity-state information.” ([0084]).
It would have been obvious to one skilled in the art to use SHMARAK’s method to determine two or more cyclic phases of motion of the anatomical element based on the plurality of pose information and a target phase of the two cyclic phases. KAISER uses ECG signals for time-gating image acquisition. One would have been motivated to add SHMARAK’s method using electromagnetic sensors (i.e., position sensors) to detect the different phases of the cardiac cycle because of the potential drawbacks of the ECG method alone. Moreover, one would have motivated to select a target phase, as taught in SHMARAK, because KAISER suggests being able to view the catheter at the same phase of a cardiac cycle. (see, e.g., [0026] of KAISER). There would have been a reasonable expectation of success as SHMARAK demonstrates that the phases of the cardiac cycle can be detected using position sensors.
SHMARAK also teaches:
update, based on the image, a multi-dimensional model of the anatomical element. “Processor 108 may further construct a three-dimensional image from captured two-dimensional images having the same activity-state, and from three-dimensional position data associated with each of the images.” ([0043]; see also [0044]: “The motion picture may consist of a projection of a constructed three-dimensional model of the organ.”).
It would have been obvious to one skilled in the art to display the image and updated, based on the image, a multi-dimensional model of the anatomical element as taught in SHMARAK. One would have been motivated to display the image to a surgeon as images often help the surgeon navigate the catheter or other surgical device. One would have been motivated to update a three-dimensional model of the heart for the same reason (i.e., to provide a more updated version of the model to the surgeon). There would have been a reasonable expectation of success as SHMARAK demonstrates that images and models can be presented to a user.
While neither SHMARK nor KAISER explicitly teach determining, from the two or more cyclic phases of motion, a target phase at which the anatomical element has less movement relative to the other phases, KAISER is clearly concerned with being able to image or view the anatomy at a particular phase. “By time-gating the image data and/or the navigation data, the location of the catheter 52 relative to the heart at the same point in the cardiac cycle may be displayed on the display 36.” (emphasis added) ([0026] of KAISER; see also [0028]).
While neither SHMARK nor KAISER explicitly teach synchronizing an imaging device with the plurality of pose information to capture an image of the anatomical element at the target phase of the two or more cyclic phases of motion (i.e., prospective-gating capture), SHMARK teaches assigning images their respective phases or activity-states. “In procedure 908, correlated phase information is obtained for the two-dimensional images data set. The phase information is correlated in the sense that the phase information is not obtained directly from the images but from correlated MPS data (occurring at the same time as a given image). The phases or activity-states of the heart, such as activity-states T1, T2 and T3 with reference to FIG. 4, during which each two-dimensional image was acquired, is identified.” ([0095]). SHMARAK teaches then displaying a motion picture for the particular activity-state. “Display 110 presents a motion picture, or image sequence, of the inspected organ in real-time…The motion picture displays the trajectory of surgical tool 120 as the surgical tool is guided within the patient body, respective of different activity-states of an inspected organ.” ([0044]).
In the same field of endeavor, MAO teaches “a method and apparatus for acquiring cardiac images having minimized motion artifact by triggering an image-acquisition scan at a point during the quiescent segment of each cardiac cycle.” (Abstract). “[I]t is an object of the present invention to provide a method and apparatus for acquiring diagnostically valuable cardiac images of the heart having minimized motion artifact via prospective gating by triggering an image-acquisition scan starting at a point of a cardiac cycle, where this point is calculated, in part, by the length of the cardiac cycle.” ([0010]).
MAO specifically teaches that “[a]cquiring clear images of the heart is typically impeded by cardiac motion and coronary artery motion caused by the rhythmic beating of the heart. The resulting loss of resolution causes blurring or streaking, called motion artifact, which diminishes the diagnostic value of these images.” ([0002]). Moreover, “[e]fforts have been made to minimize cardiac motion artifact.” ([0003]). The heart has minimized motion at “quiescent points.” ([0006]). However, “[q]uiescent points, however, vary with heart rate, so that using a fixed percentage for all subjects regardless of heart rate is ineffective.” ([0007]). “The quiescent segment, which corresponds to the period of minimized cardiac motion velocity, is late systole to early diastole, and approximates the end of the R-T segment.” ([0013]). When the quiescent phase is determined, an imaging apparatus may be synchronized to acquire images at that target phase. “This gating device synchronizes the triggering of image-acquisition scans with specific points of the cardiac cycle.” ([0015]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the KAISER system to determine a target phase from a plurality of target phases at which the anatomical element has less movement relative to the other phases and synchronize an imaging device with the plurality of pose information to capture an image of the anatomical element at the target phase of the two or more cyclic phases of motion, as taught in MAO. MAO teaches that the ideal time for acquiring images is when there is minimal motion. Based on the teachings of SHMARAK and MAO, one would have been motivated to identify a target phase (quiescent phase) and then synchronize an imaging apparatus to prospectively capture images at the target phase because to provide real-time (or nearly real-time) images of the catheter at the same activity-state. There would have been a reasonable expectation of success as MAO teaches that imaging apparatuses can be synchronized to acquire images at certain times.
With respect to claim 14, KAISER teaches that wherein the memory stores further data for processing by the processor that, when processed, causes the processor to display the image. “By time-gating the image data and/or the navigation data, the location of the catheter 52 relative to the heart at the same point in the cardiac cycle may be displayed on the display 36.” ([0026]).
With respect to claim 15, KAISER teaches that wherein the sensor comprises at least one of an inertial measurement unit tracker and an electromagnetic tracker. “The catheter 52, may be equipped with at least one, and generally multiple sensors 58 (e.g., electromagnetic sensing coils).” (emphasis added) ([0023]).
With respect to claim 16, KAISER teaches wherein the memory stores further data for processing by the processor that, when processed, causes the processor to determine a patient state based on the motion of the anatomical element. “[I]n one or more embodiments, the methods or systems use pre-programmed algorithms (e.g., executable and/or stored by workstation 34) to process wall motion data (e.g., wall motion data collected from coils 258R, 258L) to generate image data or any other type of notification information or data (e.g., data used to notify a user) that can assist a physician in selecting one or more effective pacing sites. For example, such image data may assist such selection by facilitating a methodical comparison between baseline non-paced mechanical function of the heart and the mechanical function thereof in response to pacing at one or more sites (e.g., bi-ventricular pacing).” (emphasis added). Examiner is interpreting “determine a patient state based on the motion of the anatomical element” as including processing wall motion data to display information relating to a baseline non-paced mechanical function of the heart or to display information relating to the mechanical function in response to pacing at one or more sites. Either is a patient state.
With respect to claim 17, KAISER teaches wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: determine, based on the sensor data, a velocity of the catheter as the anatomical element progresses through the two or more cyclic phases; and determine an environmental state of the catheter based on the movement and velocity. “[T]he methods or systems use pre-programmed algorithms (e.g., executable and/or stored by workstation 34) to process wall motion data (e.g., wall motion data collected from coils 258R, 258L) to generate image data or any other type of notification information or data (e.g., data used to notify a user) that can assist a physician in selecting one or more effective pacing sites.” ([0042]). “[I]mage data may be generated such that a user may select a pacing site based on maximizing wall motion (or the derivable quantities thereof, such as velocity, acceleration, or strain), based on minimizing the difference between time to peak wall motion or velocity (e.g., synchronization characteristics), or based on a combination thereof.” ([0047]). “Optimization of cardiac mechanical activation during pacing lead placement may include selecting lead placement by maximizing the magnitude of wall motion and/or the timing of wall motion, the velocity of such wall motion, or the acceleration of such wall motion, such as during isovolumic contraction and/or relaxation, or such as during systole and/or diastole. Still further, for example, optimization of cardiac mechanical activation during acute pacing lead placement may include minimizing differences in wall motion magnitude and/or the timing of wall motion, the velocity of such wall motion, or the acceleration of such wall motion, such as during isovolumic contract and/or relaxation, or such as during systole and/or diastole.” ([0041]).
Notably, KAISER teaches notifying the user that a pacing site is an optimal or non-optimal pacing site. (see, e.g., claim 10: “generating notification data indicative of the one or more first pacing sites being one of an optimal pacing site and a non-optimal pacing site.”). Examiner is interpreting “determine an environmental state of the catheter” as determining a pacing site with maximum wall motion, which may be one of the optimal pacing sites.
With respect to claim 29 (depending from claim 13), KAISER does not explicitly teach wherein determining the two or more cyclic phases of motion is further based on at least one of bio-electric signals and respiratory cycle signals. However, SHMARAK teaches using respiratory cycle signals as “supporting data” to identify the cardiac phases. “It is noted that periodic motion components relating to the respiratory motion may also be used as supporting data for cardiac phase detection.” ([0062]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the KAISER system to include identifying the cyclic phases by using, in addition to position data, data relating to respiratory motion, as taught in SHMARAK. One of ordinary skill in the art would have been motivated to use data relating to respiratory motion to more precisely detect the cardiac phases. There would have been a reasonable expectation of success as SHMARAK teaches that cardiac phases can be identified using data relating to respiratory motion in addition to other data.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2009/0198298 (hereinafter “KAISER”) and U.S. Patent Appl. Publ. No. 2009/0182224 A1 (hereinafter “SHMARAK”) and U.S. Patent Appl. Publ. No. 2004/0176681 A1 (hereinafter “MAO”) as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2021/0145576 A1 (hereinafter “BECERRA”).
With respect to claim 3, KAISER does not explicitly teach wherein at least one of the tracker, the catheter, or a combination of the tracker and the catheter is shaped to at least one of augment, decrease, or increase motion caused by fluid flow in the anatomical element.
BECERRA teaches various embodiments of a motorized delivery system for delivering implants to replace diseased heart valves. (Abstract and [0002]). The delivery system 10 includes a catheter-based device (see, e.g., Figure 1) that is configured to deliver an expandable implant 70. ([0084]). The implant 70 is held within an implant retention area 16. ([0085]). “In some embodiments, the elongate shaft 12 can hold an expandable implant in a compressed state at implant retention area 16 for advancement of the implant 70 within the body. The shaft 12 may then be used to allow controlled expansion of the implant 70 at the treatment location. In some embodiments, the shaft 12 may be used to allow for sequential controlled expansion of the implant 70….” (emphasis added) ([0088]).
The BECERRA catheters may be tracked during delivery. “The sensor may comprise a position sensor that may be utilized to determine the movement and/or position of one or more of the assemblies. For example, the position sensor may be configured to sense the amount that the motor 500 has moved the assembly to track the position and movement of the assembly.” ([0161]). Notably, one or more steps for delivering the implant may be performed “during one or more phases of the cardiac cycle, such as systole and/or diastole.” ([0263]).
BECERRA also teaches using flow sensors during deployment of the implant. ([0166]). “The sensors 583a-1 may be configured to sense a local fluid flow, such that the sensors 583a-1 may sense a fluid flow in a local area in the body that is different from the fluid flow sensed by other sensors 583a-1.” (Id). The flow sensors detect changes in the flow of blood. “For example, the sensors 583a-1 may sense a flow of blood during deployment of the implant 70, and the processor 536 may process these signals to provide an indicator to a user that leaflet mis-capture has occurred.” ([0171]). Accordingly, the BECERRA catheter is shaped (during deployment of the implant) to at least one of augment, decrease, or increase motion caused by fluid flow in the anatomical element.
It would have been obvious to one having ordinary skill in the art to use the KAISER system when delivering an implant, as taught in BECERRA, for replacing a diseased heart valve. The BECERRA implant is shaped to at least one of augment, decrease, or increase motion caused by fluid flow in the anatomical element. One would have been motivated to use the BECERRA implant because it can be tracked using the KAISER system, which can also determine the phase of the cardiac cycle for deploying the implant at the preferred time. There would have been a reasonable expectation of success as the BECERRA catheter can be tracked and the KAISER system includes a tracking/navigation system.
RESPONSE TO APPLICANT’S ARGUMENTS
While Applicant asserts that the prior art does not teach or suggest the claims, as amended, Applicant does not specifically address the teachings of KAISER or SHMARAK or any other cited reference. As discussed above, SHMARAK teaches many of the claim limitations added by the amendments of December 29, 2025. While neither KAISER nor SHMARAK explicitly teach identifying a target phase with minimal motion or synchronizing image capture with that target phase, SHMARAK does teach identifying specific phases or activity states and MAO suggests identifying those associated with reduced motion (as discussed above). MAO also suggests synchronizing image capture with the target phase.
Prior Art Made of Record
Prior art that is made of record but not relied upon in this Office Action includes:
US12239852B2, which teaches applying therapy to the heart at predetermined cardiac periods call “quiescent cardiac intervals.” US12239852B2 predicts the time and duration of these intervals. “For example, radiation beam delivery for radiation treatment may be synchronized with a cardiac signal, irradiating only during the quiescent intervals of the cardiac cycle (when heart motion is minimal) and adjusting the beam delivery speed in response to any changes in heart rate.”
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JASON P GROSS/Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
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