DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s argument on Page 13 regarding the objections to the drawings has been fully considered. While some objections were addressed, a few remain outstanding. Particularly, the specification was not amended to include elements 10, 70, and 100 (Fig. 1), 200 (Fig. 2), 916 (Fig. 9), and 1410, 1450, and 1460 (Fig. 14). The objection to the drawings is maintained.
Applicant’s argument on Page 13 regarding the objections to the specification has been fully considered. The objection to the specification is withdrawn in view of the amendments.
Applicant’s argument on Page 13 regarding the objections to Claims 1, 4-7, 9-10, 12-14, 17, and 19 has been fully considered. The objections to Claims 1, 4-7, 9-10, 12-14, 17, and 19 are withdrawn in view of the amendments.
Applicant’s argument on Pages 13-14 regarding the rejection of Claims 1-22 under 35 U.S.C. 112(b) has been fully considered. The rejection of Claims 1-22 under 35 U.S.C. 112(b) is withdrawn in view of the amendments.
Applicant’s argument on Pages 14-17 regarding the rejection of Claims 1-9 and 12-22 under 35 U.S.C. 101 has been fully considered. The rejection of Claims 1-9 and 12-22 under 35 U.S.C. 101 is withdrawn in view of the amendments.
Applicant’s argument on Pages 18-19 regarding the rejection of Claims 1 and 10-11 under 35 U.S.C. 103 over de Vaan in view of Chao has been fully considered but is not persuasive under new grounds of rejection as below.
The rejection of Claim 2 under 35 U.S.C. 103 over de Vaan in view of Chao is withdrawn in view of cancelation of the claim.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Pages 19-20 relies on the supposed deficiencies with respect to the rejection of parent Claim 1. Applicant’s argument is moot for the same reasons detailed above.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 10, 70, and 100 (Fig. 1), 200 (Fig. 2), 916 (Fig. 9), and 1410, 1450, and 1460 (Fig. 14). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 10 are objected to because of the following informalities: minor error in antecedent basis. In the preamble, it is suggested applicant amend “intracardiac procedure” to “therapeutic procedure,” and then further amending “while [[a]] the therapeutic procedure is ongoing […]” in order to establish proper antecedent basis. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: minor error in antecedent basis. The claim should be amended to “intracardiac [[therapeutic]] treatment device […] the therapeutic procedure by [[a single]] the user” in order to establish proper antecedent basis. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: grammatical error and minor error in antecedent basis. The claim should be amended to “[…] wherein [[the]] to implement the NN model […] a grasping operation of [[a leaflet]] the leaflets” in order to make sense grammatically. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: minor dependency error. The preamble of the claim fails to identify which claim the claim is dependent from. For purposes of rejection, Claim 22 is interpreted as depending from Claim 19. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-9, and 12-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the limitation “intracardiac treatment device” renders the claim indefinite. It is unclear if the intracardiac treatment device is intended to be a part of the apparatus. For purposes of applying prior art, it is interpreted that the intracardiac treatment device is not part of the system, as in [0081], which defines that the intrabody tools are any interventional intrabody tools for use during the TAVR procedure, such as leaflet grasping tools and/or resectioning tool. Therefore, an “intracardiac treatment device” is not required for the art to explicitly read on the limitations of the claim.
Claim 12 recites the limitation "the system" in Line 12. There is insufficient antecedent basis for this limitation in the claim. For purposes of applying prior art, “the system” is interpreted as “the apparatus.”
Claims not explicitly addressed above are rejected as depending from a rejected claim and failing to cure deficiencies of the parent claim.
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, 3, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Funka-Lea et al. (US 20190261945) in view of Bracken et al. (US 20180256131).
Regarding Claims 1 and 10-11, Funka-Lea teaches an apparatus for use in an intracardiac procedure, the apparatus, ([0002] “The present embodiments relate to segmentation in medical imaging to guide treatment of atrial fibrillation or other procedures.”), comprising:
a) an intracardiac echocardiography (ICE) catheter configured to be positioned inside a heart of a patient ([0099] “The ICE catheter 108 is a cardiac catheter. The ICE catheter 108 […] includes guide wires to guide the catheter 108 through the vessels of the patient to place the transducer 110 in the heart or vessel of the patient.”); and
b) a processor, ([0097] “image processor 102, and memory 104 may be part of the medical imager 106, a computer, server, workstation, or other system for image processing medical images from a scan of a patient.”), configured to:
i) control the ICE catheter to obtain a plurality of ICE images while a therapeutic procedure is ongoing, (Fig. 1, [0026] “Act 18 may be performed as part of repetition of acts 10-17, such as associated with ongoing imaging of act 10,” [0029] “In act 10, the ultrasound scanner uses an ICE catheter to image,” and [0086] “In act 18, ablation for atrial fibrillation is performed.”), the therapeutic procedure being performed on target cardiac anatomy, ([0025] “The context of use is for treatment of atrial fibrillation under the guidance of ICE imaging.”), using an intracardiac treatment device distinct from the ICE catheter ([0096] “An ablation electrode on a separate […] ICE catheter 108 is positioned for ablation based on the guidance of one or more images” and [0098] “an ablation catheter is provided.”);
ii) determine, based on the plurality of ICE images, a reference position of the ICE catheter within the heart while the therapeutic procedure is ongoing, wherein, in the reference position, the ICE catheter is configured to have visualization of the target cardiac anatomy and the intracardiac treatment device ([0025] “The left atrium may be the most common anatomy of interest for this context” and [0096] “An ablation electrode on a separate […] ICE catheter 108 is positioned for ablation based on the guidance of one or more images. By showing one or more segmented anatomical structures, the user more likely positions the electrode in the correct location to treat atrial fibrillation.” If the ablation electrode is separate from the ICE catheter 108 and placed at the anatomy of interest, then it will be within the visualization of the ICE catheter.); and
iii) track, based on the plurality of ICE images, a current position of the ICE catheter, ([0101] “The absolute position or change in position are sensed.”), while the therapeutic procedure is ongoing ([0031] “imager with image processing determines the location and orientation of the transducer for each frame.”).
Furthermore, the cited actions are computer implemented, which necessitate a computer implemented method and associated computer-readable media, as in [0109] (“The instructions for implementing the training or application processes, the methods, and/or the techniques discussed herein are provided on non-transitory computer-readable storage media or memories, such as a cache, buffer, RAM, removable media, hard drive or other computer readable storage media (e.g., the memory 104). Computer readable storage media include various types of volatile and nonvolatile storage media. The functions, acts or tasks illustrated in the figures or described herein are executed in response to one or more sets of instructions stored in or on computer readable storage media. The functions, acts or tasks are independent of the particular type of instructions set, storage media, processor or processing strategy and may be performed by software, hardware, integrated circuits, firmware, micro code and the like, operating alone or in combination.”).
However, Funka-Lea does not explicitly teach a processor configured to: detect, based on tracking the current position of the ICE catheter, a deviation from the reference position while the therapeutic procedure is ongoing, wherein, with the deviation from the reference position, the ICE catheter does not have the visualization of at least one of the target cardiac anatomy or the intracardiac treatment device; and output, to a display in communication with the processor, positional feedback while the therapeutic procedure is ongoing, wherein the positional feedback is based on detection of the deviation from the reference position and comprises instructions for a user to reposition the ICE catheter to the reference position, thereby restoring the visualization of the target cardiac anatomy and the intracardiac treatment device.
In an analogous improved views in transcatheter valve replacement field of endeavor, Bracken teaches an apparatus for use in an intracardiac procedure, the apparatus, ([0001] “This disclosure relates to medical instruments and more particularly to medical imaging and guidance using shape sensing optical fibers and ultrasound for valve replacement.”), comprising: a processor, ([0027] “one or more processors 114”), configured to:
a) detect, based on tracking the current position of the ICE catheter, a deviation from the reference position while the therapeutic procedure is ongoing, wherein, with the deviation from the reference position, (Claim 2 “wherein the reference positions include a left coronary cusp (LCC), right coronary cusp (RCC) and non-coronary cusp (NCC) are indicated on a native aortic valve in the images of the real-time imaging system." Where the reference position of the ICE catheter is when the image of the ICE catheter of Bracken includes the reference positions of Bracken (LCC, RCC, NCC).), the ICE catheter does not have the visualization of at least one of the target cardiac anatomy or the intracardiac treatment device ([0038] “Based on a pre-determined set of parameters for an improved view (e.g., spatial relationships between anatomical and/or prosthesis reference positions), a transform or other model 146 may be employed to determine movements needed to position the improved view from a current view” and [0051] “The imaging data is provided to a processing unit 606 (e.g., workstation 112). In block 604, real-time geometric data of the shape-sensed bioprosthetic valve position and orientation will be sent back to a processing unit 606. These data will be used by the processing unit 606 to calculate, send and display a simple set of instructions to the interventionalist as to how the device can be steered and positioned properly in the native aortic annulus within the improved view before deployment in block 612. The improved view parameters are selected based on the patient anatomy, the type of bioprosthetic device and user preferences, for example, positioning of cusp nadirs, etc. In block 608, a search program is initiated to locate the improved view parameters in the anatomy, e.g., locate and mark cusp nadirs in the ultrasound images.”); and
b) output, to a display in communication with the processor, positional feedback while the therapeutic procedure is ongoing, wherein the positional feedback is based on detection of the deviation from the reference position, ([0051] “The imaging data is provided to a processing unit 606 (e.g., workstation 112). In block 604, real-time geometric data of the shape-sensed bioprosthetic valve position and orientation will be sent back to a processing unit 606. These data will be used by the processing unit 606 to calculate, send and display a simple set of instructions to the interventionalist as to how the device can be steered and positioned properly in the native aortic annulus within the improved view before deployment in block 612. The improved view parameters are selected based on the patient anatomy, the type of bioprosthetic device and user preferences, for example, positioning of cusp nadirs, etc. In block 608, a search program is initiated to locate the improved view parameters in the anatomy, e.g., locate and mark cusp nadirs in the ultrasound images”), and comprises instructions for a user to reposition the ICE catheter to the reference position, thereby restoring the visualization of the target cardiac anatomy and the intracardiac treatment device ([An instruction generator 142 may be programmed to convert the position transition movements from the current view to the improved view to verbal (speech or text) instructions to a user”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Funka-Lea with Bracken because the modification improves the view in real-time as multiple devices are introduced to the patient, without ionization, as taught by Bracken in [0005]-[0006], ensure an efficient and safe procedure for the patient.
Furthermore, the cited actions are computer implemented, which necessitate a computer implemented method and associated computer-readable media, as in [0023] (“Furthermore, embodiments of the present invention can take the form of a computer program product accessible from a computer-usable or computer-readable storage medium providing program code for use by or in connection with a computer or any instruction execution system. For the purposes of this description, a computer-usable or computer readable storage medium can be any apparatus that may include, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device.”).
Regarding Claim 3, the modified apparatus of Funka-Lea teaches all limitations of Claim 1, as discussed above. Furthermore, Bracken teaches wherein the processor is further configured to generate the positional feedback further based on structural characteristics of the target cardiac anatomy, ([0051] “The improved view parameters are selected based on the patient anatomy, the type of bioprosthetic device and user preferences, for example, positioning of cusp nadirs, etc. In block 608, a search program is initiated to locate the improved view parameters in the anatomy, e.g., locate and mark cusp nadirs in the ultrasound images.”), and one or more of: a field of view of the ICE catheter in the current position, ([0059] “In block 706, the real-time images are searched to identify reference positions of the native valve in the volume.”), and a desired view in the reference position ([0059] “In block 710, an improved view is computed in accordance with improved view parameters. The improved view parameters may include a view that depicts reference points or features in a certain way, e.g., as far apart as possible, equidistant from each other, a particular feature on the bottom, or other geometric relationship. The improved view parameters may include showing the prosthesis or device in a user-preferred or user-selected view. In the example above, the improved view parameters may include a spatial relationship between the LCC, RCC and NCC (e.g., equidistant from each other, etc.) or mitral valve features (e.g., cusps, annulus, etc.).”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Bracken for the same reasons as Claim 1 above.
Claims 4 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Funka-Lea et al. (US 20190261945) in view of Bracken et al. (US 20180256131), as applied to Claim 1, further in view of Stahler et al. (US 20120071895).
Regarding Claim 4, the modified apparatus of Funka-Lea teaches all limitations of Claim 1, as discussed above. However, the modified apparatus of Funka-Lea does not explicitly teach wherein the processor is further configured to: predict a safe zone as a virtual volume around the reference position, the safe zone encompassing positions the ICE catheter can reside in during the therapeutic procedure while maintaining the visualization of the target cardiac anatomy and the intracardiac treatment device; and determine whether the deviation from the reference position causes the current position to be outside the safe zone.
In an analogous controllable surgical system field of endeavor, Stahler teaches an apparatus for use in an intracardiac procedure, ([0366] “An intracardiac (ICE) ultrasound imaging catheter 112 is positioned in a working lumen of the guide catheter 61a”), the processor is further configured to:
a) predict a safe zone as a virtual volume around the reference position, the safe zone encompassing positions the ICE catheter can reside in during the therapeutic procedure while maintaining the visualization of the target cardiac anatomy and the intracardiac treatment device ([0348] “catheter workspace limitation 176, which may be a function of the experimentally determined physical limits of the instrument beyond which componentry may fail, deform undesirably, or perform unpredictably or undesirably. This workspace limitation defines a volume similar to a cardioid-shaped volume about the distal end of the instrument. Desired pitch, yaw, and extension commands, limited by the workspace limitation block” and [0366] “The ICE catheter 112 may be extended out of, and retracted into, respectively, the distal end opening in the guide catheter 61a, as indicated by arrow 115A, and may be rotated about its longitudinal axis, as indicated by arrow 115B, such that a transducer array 113 on the ICE catheter 112 is positionable within the anatomic workspace 116 to capture ultrasound images within a field of view 114 of the array 113.”); and
b) determine whether the deviation from the reference position causes the current position to be outside the safe zone ([0367] “Depending on factors such as the anatomical boundaries and tissue structures in the anatomical workspace 116, and the relative positions and prior trajectories of the sheath 62a, guide catheter 61a, and ICE catheter 112 within the workspace 116, the system controller (not shown in FIG. 32) can model the potential relative movement the respective sheath 62a, guide 61a, and ICE catheter 112, and thus the potential movement of the field of view 114 of the transducer array 113 within the work space 116. In particular, certain tissue walls and/or structures within the anatomic workspace 116 can be readily imaged (or "viewable") by the ICE transducer 113 without requiring anything more than a relatively simple repositioning of the respective sheath 62a, guide 61a, and ICE catheter 112, respectively, such as tissue structure 117”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Stahler because the modification may be used to define preset scan planes for real-time use, monitor and alert from deviations from the target view, and/or display the appropriate view without requiring further operator input. Additionally, the combination minimizes potential of error during the procedure and damage to the patient during navigation.
Regarding Claim 7, the modified apparatus of Funka-Lea teaches all limitations of Claim 4, as discussed above. Furthermore, Stahler teaches wherein the virtual volume of the safe zone is determined further based on a set of positional tolerances defined to accommodate an extent of motion of the ICE catheter without loss of the visualization of the target cardiac anatomy and the intracardiac treatment device ([0367] “Depending on factors such as the anatomical boundaries and tissue structures in the anatomical workspace 116, and the relative positions and prior trajectories of the sheath 62a, guide catheter 61a, and ICE catheter 112 within the workspace 116, the system controller (not shown in FIG. 32) can model the potential relative movement the respective sheath 62a, guide 61a, and ICE catheter 112, and thus the potential movement of the field of view 114 of the transducer array 113 within the work space 116. In particular, certain tissue walls and/or structures within the anatomic workspace 116 can be readily imaged (or "viewable") by the ICE transducer 113 without requiring anything more than a relatively simple repositioning of the respective sheath 62a, guide 61a, and ICE catheter 112, respectively, such as tissue structure 117 in FIG. 21. Other tissue wall locations and/or structures may be viewable, but only by more complicated maneuvering techniques, including iterative movements of one or more of the sheath 62a, guide 61a, and/or ICE catheter 112, respectively, in order to position the transducer 113 and field of view 114, such as tissue structure 118”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the teachings of Stahler because the modification provides the advantage of being applicable for varying types of applications, which may be different depending on the patient, accessibility, or other causes for deviation from the target path or region.
Regarding Claim 8, the modified apparatus of Funka-Lea teaches all limitations of Claim 4, as discussed above. Furthermore, Funka-Lea teaches wherein the processor is further configured to:
a) receive an x-ray image of the ICE catheter ([0101] “an external x-ray or acoustic sensor that senses one or more fiducials or the transducer 110 on the ICE catheter 108.”);
b) generate a representation of the safe zone for overlay with the x-ray image ([0031] “In act 11, a sensor senses the positions of the scan planes. A magnetic position sensor, fiducials with x-ray or acoustic scanning, or imager with image processing determines the location and orientation of the transducer for each frame. The location and orientation define the scan plane. The position of each scan plane is sensed. Different scan planes have different positions. The positions of the scan planes within a cardiac system (e.g., heart and/or vessels) of a patient are sensed for the ICE imaging of act 10.”); and
c) generate the positional feedback based on the x-ray image and the representation of the safe zone ([0031] “The positions of the scan planes within a cardiac system (e.g., heart and/or vessels) of a patient are sensed for the ICE imaging of act 10” and [0106] “An image may be generated as a slice through the 3D segmentation and/or more complete volume. The 2D segmentation alone or overlaid with the 2D ICE image may be generated. Annotations, coloring, graphics, or other highlighting may be used to show the 2D segmentation or rendered 3D segmentation.”).
Regarding Claim 9, the modified apparatus of Funka-Lea teaches all limitations of Claim 1, as discussed above. Furthermore, Stahler teaches wherein the instructions for the user to reposition the ICE catheter to the reference position comprises one or more of: a representation of a safe zone ([0366] “The ICE catheter 112 may be extended out of, and retracted into, respectively, the distal end opening in the guide catheter 61a, as indicated by arrow 115A, and may be rotated about its longitudinal axis, as indicated by arrow 115B, such that a transducer array 113 on the ICE catheter 112 is positionable within the anatomic workspace 116 to capture ultrasound images within a field of view 114 of the array 113.”); a deviation of the current position from the safe zone; or instructions for repositioning the intrabody ICE probe head to reposition the ICE catheter to within the safe zone.
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the teachings of Stahler because the modification may be used to define preset scan planes for real-time use, monitor and alert from deviations from the target view, and/or display the appropriate view without requiring further operator input. Additionally, the combination minimizes potential of error during the procedure and damage to the patient during navigation.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Funka-Lea et al. (US 20190261945) in view of Bracken et al. (US 20180256131), as applied to Claim 1, further in view of de Vaan et al. (US 20200170617).
Regarding Claim 5, the modified apparatus of Funka-Lea teaches all limitations of Claim 1, as discussed above. However, the modified apparatus of Funka-Lea does not explicitly teach wherein the processor is configured to: determine, using the plurality of ICE images, a similarity measure representative of a similarity between a current view of the ICE catheter at the current position and a predetermined view associated with the reference position; and determine that the ICE catheter has the visualization of the target cardiac anatomy and the intracardiac treatment device based on the similarity measure satisfying a threshold, thereby determining the reference position to be the current position.
In an analogous intracavity probe procedure planning field of endeavor, de Vaan teaches an apparatus for use in an intracardiac procedure, (Abstract “A method (and imaging system) for planning a medical intervention on patient is provided that involves an intracavity probe and an imaging dataset of the patient,”) wherein the processor, ([0171] “Processes described herein (or variations and/or combinations thereof) may be performed under the control of one or more computer systems configured with executable instructions and may be implemented as code (e.g., executable instructions, one or more computer programs or one or more applications) executing collectively on one or more processors, by hardware or combinations thereof.”), is configured to:
a) determine, using the plurality of ICE images, a similarity measure representative of a similarity between a current view of the ICE catheter at the current position and a predetermined view associated with the reference position ([0107] “During the actual TEE procedure, the operator can use the virtual TEE images and try to obtain real TEE images in the patient that replicate one or more virtual TEE images. An embodiment for this workflow is now disclosed with reference to FIG. 13. During the TEE procedure, the operator opens the TEE plan (1301) as generated within the workflow depicted by FIG. 1, either on paper, or as an electronic document. Next, the operator calibrates the calculated distance offsets (1302) between the TEE plan and the actual patient. The depth/distance values 602 recorded during planning are calibrated against the scale printed on the shaft by manually registering a live TEE image with an image from planning, thus determining the offset between the two scales” and [0120] “The presently disclosed methods also hold for ICE”); and
b) determine that the ICE catheter has the visualization of the target cardiac anatomy and the intracardiac treatment device based on the similarity measure satisfying a threshold, thereby determining the reference position to be the current position (Fig. 13, where steps Next TEE View 1305 and Done 1306 are interpreted as determining the current view to be the desired view based on the similarity measure satisfying a threshold because the procedure either moves to a new viewpoint to fit the predetermined threshold, or finishes.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of de Vaan because the modification ensures quality imaging with minimal discomfort to the patient, as the imaging process is carried out as efficiently as possible.
Regarding Claim 6, the modified apparatus of Funka-Lea teaches all limitations of Claim 5, as discussed above. Furthermore, de Vaan teaches wherein the processor is configured to determine a safe zone based on the similarity measure such that a volume of the safe zone increases with increasing similarity measure ([0108] “One example of such manual matching is by using one of the planned TEE views from the workflow as described by FIG. 1 as a reference TEE view. For all other planned TEE views within the workflow as described by FIG. 1, the computed shaft insertion depth is relative to this reference TEE view. Such reference TEE view can be defined by one or more anatomical structures which is relatively easy to image, for instance the aortic valve. Such manual matching using the aortic valve is illustrated in FIG. 15. The left image shows the aortic valve (1501) on the reference TEE view and on the right the aortic valve (1502) on the live TEE image. If “relative distances” (probe location in the esophagus) is used during the workflow as illustrated by FIG. 1, calibration and re-calibration is done simply reproducing the “zero distance” view on the live TEE image acquired by the TEE probe.” The closer the ICE catheter ([0120]) gets to matching the planned view, the safe zone increases, since the ICE catheter is closer to the ideal location to match the planned view.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of de Vaan because the modification ensures accurate movement of the TEE probe which is visually depicted to the user by way of the safe zone increasing.
Claims 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Funka-Lea et al. (US 20190261945) in view of Bracken et al. (US 20180256131), as applied to Claim 1, further in view of Bridges (WO 2014210299).
Regarding Claim 12, the modified apparatus of Funka-Lea teaches all limitations of Claim 1, as discussed above. However, the modified apparatus of Funka-Lea does not explicitly teach an inflatable balloon disposable about a distal end of the ICE catheter; wherein the inflatable balloon comprises: a first state for insertion of the inflatable balloon into a vessel lumen together with the ICE catheter during the therapeutic procedure and a second state to stabilize the ICE catheter within the vessel lumen, wherein the system is configured such that the inflatable balloon is configured to be inflated to cause the inflatable balloon to: change from the first state to the second state while deployed in the vessel lumen together with the ICE catheter; and exert a compression force to part of the ICE catheter and at least part of a wall of the vessel lumen surrounding the ICE catheter to thereby provide the stabilization.
In an analogous implantation of a prosthetic heart valve field of endeavor, Bridges teaches an apparatus for use in an intracardiac procedure, (Abstract “A prosthetic valve assembly, system, and method for replacing a heart valve is provided.”), further comprising:
a) an inflatable balloon disposable about a distal end of the ICE catheter (Fig. 4D “balloon 18” and Page 8 Lines 5-6 “Visualization may also be performed using transthoracic or intracardiac echocardiogram.”);
b) wherein the inflatable balloon comprises:
i) a first state for insertion of the inflatable balloon into a vessel lumen together with the ICE catheter during the therapeutic procedure (Fig. 4A, where when inserted, the balloon is not inflated, interpreted as the first state.); and
ii) a second state to stabilize the ICE catheter within the vessel lumen, (Fig. 4D and Page 15 Lines 21-24 “Finally, in FIG. 4D, the balloon 18 is inflated to cause the prosthetic valve 16 to radially expand into contact with the aortic annulus, as indicated by the arrows 430. FIG. 4D shows the balloon inflation catheter 12 projecting from the sheath 22 and through the balloon and prosthetic valve.”),
c) wherein the system is configured such that the inflatable balloon is configured to be inflated to cause the inflatable balloon to:
i) change from the first state to the second state while deployed in the vessel lumen together with the ICE catheter (Figs. 4C-4D); and
ii) exert a compression force to part of the ICE catheter and at least part of a wall of the vessel lumen surrounding the ICE catheter to thereby provide the stabilization (Fig. 4D and Page 15 Lines 21-25 “Finally, in FIG. 4D, the balloon 18 is inflated to cause the prosthetic valve 16 to radially expand into contact with the aortic annulus, as indicated by the arrows 430. FIG. 4D shows the balloon inflation catheter 12 projecting from the sheath 22 and through the balloon and prosthetic valve. Once the valve 16 is fully expanded and securely attached to the annulus”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Bridges because the modification allows for efficient replacement of the aortic valve, which minimizes risk of misplacement, which can cause a life-threatening emergency to the patient, as taught by Bridges on Page 2, if such treatment is needed in addition to the therapeutic treatment as taught by Funka-Lea.
Regarding Claim 13, the modified apparatus of Funka-Lea teaches all limitations of Claim 12, as discussed above. Furthermore, Bridges teaches wherein the inflatable balloon comprises a first opening at a distal end of the inflatable balloon, (Fig. 1, annotated and reproduced by examiner below), a second opening at a proximal end of the inflatable balloon, (Fig. 1, annotated and reproduced by examiner below), and a lumen connecting the first and second opening, the lumen being configured to accommodate at least part of the ICE catheter (Fig. 1, annotated and reproduced by examiner below, where the ICE catheter is interpreted as the catheter 12.).
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Fig. 1 of Bridges
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Bridges for the same reasons as Claim 12.
Regarding Claim 14, the modified apparatus of Funka-Lea teaches all limitations of Claim 12, as discussed above. Furthermore, Bridges teaches wherein the inflatable balloon comprises a compliant material configured to prevent overstretching of the vessel lumen when the inflatable balloon device is in the second state (Fig. 2 and Page 15 Lines 21-24 “Finally, in FIG. 4D, the balloon 18 is inflated to cause the prosthetic valve 16 to radially expand into contact with the aortic annulus, as indicated by the arrows 430. FIG. 4D shows the balloon inflation catheter 12 projecting from the sheath 22 and through the balloon and prosthetic valve.” Where the design of the balloon device of Bridges, by nature, will not overstretch the vessel lumen due to the objective of the device, which is to place the prosthetic valve 16.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the design of the ICE probe with the teachings of a compliant material of Bridges because the modification allows for minimal discomfort or injury to the patient.
Regarding Claim 15, the modified apparatus of Funka-Lea teaches all limitations of Claim 12, as discussed above. Furthermore, Bridges teaches wherein the inflatable balloon is an occlusion balloon (Page 1 Lines 6-7 “Aortic valve stenosis (AS) is a disease of the heart valves in which the opening of the aortic valve is narrowed” and Page 13 Line 6 “the valve, mounted on the balloon in a collapsed state,” where the valve is merely mounted on the balloon, with the understanding that the balloon may, if necessary, be inserted and inflated within the patient without the valve, still expanding the artery.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the design of the ICE probe with the teachings of an occlusion balloon type device of Bridges because the modification decreases the patient’s risk of heart failure, as taught by Bridges on Page 1 Line 7.
Regarding Claim 16, the modified apparatus of Funka-Lea teaches all limitations of Claim 12, as discussed above. Furthermore, Bridges teaches wherein the inflatable balloon is shaped such that, in the second state, the inflatable balloon is configured to provide a channel for blood flow extending from a proximal end to a distal end of the inflatable balloon (Fig. 4D, where the balloon expands within vessel of the heart, to promote proper blood flow).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the design of the ICE probe with the teachings of Bridges for the same reasons as Claim 12.
Regarding Claim 17, the modified apparatus of Funka-Lea teaches all limitations of Claim 12, as discussed above. Furthermore, Bridges teaches wherein, to stabilize the ICE catheter, the inflatable balloon is configured to reduce or prevent motion of the ICE catheter cat least one of: blood flow in the vessel lumen, cardiac motion, or user interaction (Page 15 Lines 24-28 “Once the valve 16 is fully expanded and securely attached to the annulus, the balloon is deflated and removed. Such an operation may include elongating the balloon in the distal direction and reducing its radial dimension by, for example, twisting. After the balloon has been retracted within the sheath, the entire catheter is removed from the patient.” Where the balloon, securing the catheter 12 will be limited in movement upon interaction with blood flow, cardiac motion, or until the user decides to remove the balloon.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further combine the teachings of Bridges because the combination minimizes error in the procedure within the region of interest. It is ideal for the probe head to not move, as it will skew the procedure and any treatment plan of the operator.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Funka-Lea et al. (US 20190261945) in view of Bracken et al. (US 20180256131) and Bridges (WO 2014210299), as applied to Claim 12, further in view of Weber et al. (“Laser catheter ablation of long-lasting persistent atrial […]”).
Regarding Claim 18, the modified apparatus of Funka-Lea teaches all limitations of Claim 12, as discussed above. Furthermore, Funka-Lea teaches wherein in response to the balloon device stabilizing the probe head in the vessel lumen (taught by Bridges, as discussed above), a laser catheter is enabled to perform ablation for the intracardiac procedure by a single user ([0086] “In act 18, ablation for atrial fibrillation is performed. The electrode or other ablator is positioned adjacent tissue to be scarred or ablated.” Where it is understood by one of ordinary skill in the art that an ablator may be a laser catheter, see Weber NPL.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further combine the teachings of the laser ablation catheter of Funka-Lea, the balloon device of Bridges, and the remaining limitations taught by Bracken because the combination allows for precise removal of any unwanted tissue by laser during a vascular occlusion procedure, if deemed necessary, which ultimately benefits the patient’s health. Additionally, laser ablation has low risk, a short procedure time, and reduces redo procedures, as taught by Weber.
Claims 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Funka-Lea et al. (US 20190261945) in view of Bracken et al. (US 20180256131), as applied to Claim 1, further in view of Chao et al. (US 20200129142).
Regarding Claim 19, the modified apparatus of Funka-Lea teaches all limitations of Claim 1, as discussed above. Furthermore, Bracken teaches wherein the therapeutic procedure comprises a valve resection procedure, ([0001] “This disclosure relates to medical instruments and more particularly to medical imaging and guidance using shape sensing optical fibers and ultrasound for valve replacement.”), comprising: wherein the plurality of ICE images comprise cross-sectional views of leaflets, ([0055] “Based on the visibility requirements of the native mitral valve leaflets and commissures in ultrasound images, improved view parameters to position and deploy mitral clips could be implemented into the processing unit 606.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Bracken to ensure proper placement of elements during the procedure.
However, the modified apparatus of Funka-Lea does not explicitly teach wherein the processor is further configured to implement a Neural Network (NN) model configured to detect and to predict a plurality of three-dimensional landmarks in the valve resection procedure for proper localization, wherein the NN model is a semi-supervised trained NN based on a set of ultrasound anatomical images generated in a prior valve resection procedure, wherein, the implement the NN model, the processor configured to process the plurality of ICE images to monitor a grasping operation of a leaflet by a grasping mechanism and to provide confirmation of proper leaflet insertion during the grasping operation.
In an analogous intraluminal ultrasound field of endeavor, Chao teaches an apparatus for use in an intracardiac procedure, ([0054] “the intraluminal imaging system 100 may include systems configured for […] intracardiac echocardiography (ICE), transesophageal echocardiography (TEE)”), the apparatus comprising: a processor, ([0060] “The processing system 106 may be operable to facilitate the features of the intraluminal imaging system 100 described herein. For example, the processor can execute computer readable instructions stored on the non-transitory tangible computer readable medium.”),
a) wherein the processor is further configured to implement a Neural Network (NN) model configured to detect and to predict a plurality of three-dimensional landmarks in the valve resection procedure for proper localization, ([0113] “In step 2430, the processor 106 performs border detection, image processing, image analysis, and pattern recognition of the captured IVUS image to identify anatomical landmarks (e.g., specific veins, and branching points between veins). While the pullback run is performed, the algorithm detects these landmarks based on a-priori information of the venous system geometry.”),
c) wherein the NN model is a semi-supervised trained NN based on a set of ultrasound anatomical images generated in a prior valve resection procedure, ([0113] “Such analysis and recognition may rely on conventional techniques, or may be training-based or learning-based (e.g., incorporating machine learning, deep learning, or other related artificial intelligence).”),
d) wherein, the implement the NN model, the processor configured to process the plurality of ICE images to monitor a grasping operation of a leaflet by a grasping mechanism and to provide confirmation of proper leaflet insertion during the grasping operation ([0062] “the device 102 may be used to examine any number of anatomical locations and tissue types, including without limitation, organs including the […] heart, […] as well as valves within the blood, chambers or other parts of the heart, and/or other systems of the body. In addition to natural structures, the device 102 may be used to examine man-made structures such as, but without limitation, heart valves, stents, shunts, filters and other devices,” where leaflets are interpreted as other parts of the heart, [0104] “The IVUS pullback virtual venogram system may be generally capable of automatically identifying different regions of a patient's circulatory system by using a machine-learning algorithm or other training-based AI algorithm to match IVUS images against an a priori dataset or knowledge set of statistically representative lumen anatomy for different human subpopulations,” and [0120] “In step 2490, if an appropriate user input has been selected, the processing system 106 provides guidance to the clinician regarding movements of the intravascular imaging probe controls 104 that may be required to advance or retract the probe 102 to a desired location within the patient's body, or to mark the start or end of a given vascular segment, or to start or stop recording. Such guidance may be determined through conventional techniques (e.g., database lookup) or through learning-based techniques.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further combine the teachings of a neural network model of Chao because the combination of inclusion of a neural network model, which may be added to a processor of the apparatus, minimizes the risk of human error based judgement during the procedure, which thereby minimizes risk to the patient.
Regarding Claim 20, the modified apparatus of Funka-Lea teaches all limitations of Claim 19, as discussed above. Furthermore, Chao teaches wherein to determine the proper leaflet insertion, the processor is configured to implement the NN model to track movement of the leaflets during the grasping operation for comparisons of aspects of leaflet motion ([0113] “In step 2430, the processor 106 performs border detection, image processing, image analysis, and pattern recognition of the captured IVUS image to identify anatomical landmarks (e.g., specific veins, and branching points between veins). While the pullback run is performed, the algorithm detects these landmarks based on a-priori information of the venous system geometry. Such analysis and recognition may rely on conventional techniques, or may be training-based or learning-based (e.g., incorporating machine learning, deep learning, or other related artificial intelligence).” Where identifying anatomical landmarks is interpreted as tracking the leaflets.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Chao for the same reasons as Claim 19 above.
Regarding Claim 21, the modified apparatus of Funka-Lea teaches all limitations of Claim 20, as discussed above. Furthermore, Chao teaches wherein, to determine the proper leaflet insertion, the processor is configured to implement the NN model to compare pre-grasping leaflet motion versus post-grasping leaflet motion ([0113] “In step 2430, the processor 106 performs border detection, image processing, image analysis, and pattern recognition of the captured IVUS image to identify anatomical landmarks (e.g., specific veins, and branching points between veins). While the pullback run is performed, the algorithm detects these landmarks based on a-priori information of the venous system geometry. Such analysis and recognition may rely on conventional techniques, or may be training-based or learning-based (e.g., incorporating machine learning, deep learning, or other related artificial intelligence),” [0115] “In step 2450, the processor 106 is receptive to optional additional inputs from the user, comprising information to assist the pattern recognition algorithm,” and [0116] “In step 2460, if the user has entered such corrections during step 2550, the processing system 106 updates the information located within the algorithm to reflect the corrections.” Where a comparison between action images is commonly understood as a foundation of machine learning in the art.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Chao for the same reasons as Claim 19 above.
Regarding Claim 22, the modified apparatus of Funka-Lea teaches all limitations of Claim 21, as discussed above. Furthermore, Chao teaches wherein the processor is configured to implement the NN model to estimate pre-grasping leaflet motion versus post-grasping leaflet motion in advance the proper leaflet insertion ([0113] “In step 2430, the processor 106 performs border detection, image processing, image analysis, and pattern recognition of the captured IVUS image to identify anatomical landmarks (e.g., specific veins, and branching points between veins). While the pullback run is performed, the algorithm detects these landmarks based on a-priori information of the venous system geometry. Such analysis and recognition may rely on conventional techniques, or may be training-based or learning-based (e.g., incorporating machine learning, deep learning, or other related artificial intelligence),” [0115] “In step 2450, the processor 106 is receptive to optional additional inputs from the user, comprising information to assist the pattern recognition algorithm,” and [0120] “In step 2490, if an appropriate user input has been selected, the processing system 106 provides guidance to the clinician regarding movements of the intravascular imaging probe controls 104 that may be required to advance or retract the probe 102 to a desired location within the patient's body, or to mark the start or end of a given vascular segment, or to start or stop recording. Such guidance may be determined through conventional techniques (e.g., database lookup) or through learning-based techniques.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Chao for the same reasons as Claim 19 above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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/MARIA CHRISTINA TALTY/ Examiner, Art Unit 3797
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795