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 .
Status of Claims
Claim 1 is amended and Claims 1-18 are currently pending in this application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 5-10, 12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tuason et al. (US 20190060003 A1) in view of Bharat (US20170202625A1), Rohling (US20160022308A1), and in further view of Kruecker (US20170304644A1).
Regarding Claim 1,
Tuason teaches a medical system (70), comprising:
a utility probe (corresponding disclosure in at least [0053] and Figure 6A, where there is a delivery catheter (186) for insertion into a cavity of an organ (i.e. a patient (72)) (at least fig. 6a [see below]) comprising:
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a distal end effector (189) fitted at a distal end (at 189) of the utility probe (Fig 12 and [0053] disclose a prosthetic valve, which is placed at the distal end of the catheter)
a first sensor, configured to output first signals indicative of first positions of the distal end effector inside the cavity (positioning sensors are mentioned but not shown in the figure, positioned at the distal portions of the catheters (186, 188), corresponding disclosure at least [0053]).
an ultrasound probe for insertion into an organ of a body (an ECHO imaging catheter (188) disclosed in [0053] and fig. 11 for insertion into the organ of the body) comprising:
an ultrasound transducer array configured to image a volume of the organ, the volume comprising at least a portion of the distal end effector (see ECHO imaging catheter with an ultrasound transducer array as shown in below re-produced fig. 11, which is configured to image a volume (184) and confirm the proper position of the delivery catheter (186). The ECHO imaging catheter (188) also includes electrodes/sensors on the distal end, which is disclosed at least in fig. 8a, 8b, and [0049]).
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and a second sensor configured to output second signals indicative of second positions of the ultrasound transducer array inside the cavity (corresponding disclosure in at least [0042], where multiple position indicators (sensors) are configured for locating the position of the distal end; having multiple sensors would indicate a second position “an EP imaging catheter 50 according to the invention is depicted, with the elongated catheter shaft 52 advanced through the patient's vascular system to position the imaging catheter distal end 54”, and further in [0053], where the ultrasound transducer array, or the ECHO catheter also includes positioning sensors “the positions of the valve delivery catheter 186 and/or ECHO catheter 188 may be provided by the electrophysiological 3D mapping system, such as where the valve delivery catheter 186 and/or ECHO catheter 188 have one or more positioning sensors (not shown) thereon or therein (e.g., sensors positioned at the distal portions of the catheter(s) 186, 188)”).
a processor (88).
Tuason does not specify using the imaged volume, the first positions, and the second positions, select one or more of slices of the imaged volume based on tracking of the ultrasound probe and the distal end effector, the one or more slices comprising at least part of the distal end effector in spatial relation with the organ, wherein each of the one or more slices corresponds to a planar slice that intersects the distal end effector and generating from the one or more selected slices at least one of a biplane (i.e. 2D) view and triplane (i.e. 3D) view of the part of the distal end effector.
Bharat, in a similar field of endeavor, teaches a similar concept (visualization and tracking of probe) of using the imaged volume, the first positions, and the second positions, select one or more of slices of the imaged volume based on tracking of the distal end effector, the one or more slices comprising at least part of the distal end effector in spatial relation with the organ, wherein each of the one or more slices corresponds to a planar slice that intersects the distal end effector (corresponding disclosure in at least [0046], where based on the position of where the distal end effector, or the biopsy tool, is, an image slice is selected, which includes the view of the instrument used “The displayed 2D TRUS image 202 is re-rendered in real-time (from the live 3D image) to coincide with a current position and pose of the biopsy tool shaft 204. As the tool 204 is advanced, the 2D image 202 on the screen is updated” and further in [0042], “the interpretation module 45 selects image slices 78, e.g., 2D TRUS/MR image slices to display, so it contains the real-time tracked tool position(s). The interpretation module 45 employs a field of view that includes all or some trackable features (e.g., sensor position, instrument position, biopsy/target location, etc.). Using the positions (e.g., depths), the interpretation module 45 selects an image slice (50) that best defines the relationship between the sensors 22 on the needle 14 and the biopsy location. The interpretation module 45 may select a plane where all trackable positions are present or may select another plane based upon criteria stored in the interpretation module 45 that best shows the relationship. The criteria may include an angle for best viewing internal organs, best viewing the target, best viewing the needle or other instrument, etc.”; and further in [0046] and Figure 3, where the view plane is selected with the slice intersecting, or the in-plane view “ the in-plane positions of two or three reference points are employed to select the view plane. This feature provides a real-time view of the anatomy in the vicinity of the biopsy tool, which can be especially useful during insertion of the tool 204”).
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Figure 3 of Bharat
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated using the imaged volume and position information to select a slice of the image with the distal end effector as taught by Bharat. One of the ordinary skill in the art would have been motivated to incorporate this because the position information of the surgical instrument is more accurately determined and a further image is then generated with the updated view.
Tuason and Bharat do not specify generating from the one or more selected slices at least one of a biplane (i.e. 2D) view and triplane (i.e. 3D) view of the part of the distal end effector and selecting one or more slices based on tracking of an ultrasound probe.
Rohling, in a similar field of endeavor, teaches a similar concept (visualization of surgical instrument with ultrasound) of generating from the one or more selected slices at least one of a biplane (i.e. 2D) view and triplane (i.e. 3D) view of the part of the distal end effector; and present the at least one of the biplane view and triplane view to a user (corresponding disclosure in at least [0143], where one or more selected slices are used to show a biplane, or 2D view as well as a 3D view of the distal end effector, or the needle, then further displaying the views to the user “the thick slice sagittal image 603 coincides with a plane that is sagittal to the patient and intersects the graphic overlay 1302 of the propagation axis of the medical instrument guide… As the needle 405 is inserted deeper into the tissue, more and more of the needle 405 becomes visible in the image 603. The operator aligns the graphic overlay 1302 of the propagation axis with the target 404 so that subsequent insertion of the needle 405 into tissue reaches the target 404. This image 603 is updated on the image display device as the ultrasound 3-D volumetric dataset is created by probe. In this way, the apparatus provides current images of the needle insertion procedure”, where the 3D image is updated based on the selected slices, which correspond to the needle entry).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated generating from one or more selected slices a biplane and triplane view as taught by Rohling. One of the ordinary skill in the art would have been motivated to incorporate this because the generated view properly represents an updated image during the insertion of the device.
The combined references do not teach selecting one or more slices based on tracking of an ultrasound probe.
Kruecker, in a similar field of endeavor, teaches a similar concept (selecting ultrasound image slices) of selecting one or more slices based on tracking of an ultrasound probe (corresponding disclosure in at least [0084], where the selected image slice is based on the location of the US probe “The selected image slice may be selected from the reference dataset and may have a location which most closely matches a location of the current image. Accordingly, the process may determine a location of the current image (e.g., based upon location of the TRUS probe) along a predetermined axis (e.g., the z axis as determined by a location of the TRUS probe)”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated selecting one or more slices based on tracking of an ultrasound probe as taught by Kruecker. One of the ordinary skill in the art would have been motivated to incorporate this because the tracking of the ultrasound probe assists in further determining the probe orientation.
Regarding Claim 3 and Claim 12, the combined references noted above teach the limitations of Claim 1, and Tuason further teaches wherein part of the distal end effector comprises an artificial valve (corresponding disclosure in at least [0053] and Figure 11, where there is an artificial valve “can view the combined images on the display 180 and use the information provided to guide the proper positioning of the prosthetic valve 189 and delivery catheter”).
Regarding Claim 5 and Claim 14, the combined references noted above teach the limitations of Claim 1, and Tuason further teaches wherein the first and second sensors are magnetic position sensors configured to generate the first and second signals in response to a magnetic field applied by a position tracking system (corresponding disclosure in at least [0009], [0011], and [0012], the catheter has one or more tracking electrode/sensor, which interacts with an external sensor/electromagnetic array, or magnetic coils to track the position of the catheter tracking sensor/electrode).
Regarding Claim 6 and Claim 15, the combined references noted above teach the limitations of Claim 1, and Tuason further teaches wherein the first sensor is an electrode of the distal end effector configured to generate the first signals as part of an electrical position tracking system (An electrode/sensory array (142) is positioned distally alongside the prosthetic valve (138), which is on the distal end effector (189) (corresponding disclosure in at least [0050] and in fig. 9b)).
Regarding Claim 7 and Claim 16, the combined references noted above teach the limitations of Claim 1, and Bharat further teaches wherein the processor is configured to select one or more slices using an image processing algorithm (corresponding disclosure in at least [0042], where the algorithm, or the interpretation module, selects image slices “the interpretation module 45 may be employed to interpret a tracked 3D image volume 76 to determine a position and orientation of the biopsy tool or needle 14 with respect to a current image slice or image 78. The interpretation module 45 selects image slices 7”).
Regarding Claim 8 and Claim 17, the combined references noted above teach the limitations of Claim 1, and Rohling further teaches wherein the processor is configured to generate from one or more selected slices at least one of a biplane view and triplane view using an image processing algorithm (corresponding disclosure in at least [0143], where one or more selected slices are used to show a biplane, or 2D view as well as a 3D view of the distal end effector, or the needle, then further displaying the views to the user “the thick slice sagittal image 603 coincides with a plane that is sagittal to the patient and intersects the graphic overlay 1302 of the propagation axis of the medical instrument guide… As the needle 405 is inserted deeper into the tissue, more and more of the needle 405 becomes visible in the image 603. The operator aligns the graphic overlay 1302 of the propagation axis with the target 404 so that subsequent insertion of the needle 405 into tissue reaches the target 404. This image 603 is updated on the image display device as the ultrasound 3-D volumetric dataset is created by probe. In this way, the apparatus provides current images of the needle insertion procedure”, where the 3D image is updated based on the selected slices, which correspond to the needle entry, and further in [0139], where this is completed through an image processing algorithm, or method (1000) “a data processing method 1000 is carried out by the system 900 to manipulate the 3-D volumetric dataset acquired by the ultrasound probe to produce a 2-D thick slice sagittal plane image 603 and a 2-D thick slice transverse plane image 604”).
Regarding Claim 9 and Claim 18, the combined references noted above teach the limitations of Claim 1, and Tuason further teaches wherein the cavity of the organ is a cardiac chamber of a heart (10) (corresponding disclosure in at least [0040]).
Regarding Claim 10,
Tuason teaches a medical method (70), comprising:
inserting a utility probe into a cavity of an organ (corresponding disclosure in at least [0053] and Figure 6A, where there is a delivery catheter (186) for insertion into a cavity of an organ (i.e. a patient (72)) (at least fig. 6a [see below]) the utility probe comprising:
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a distal end effector (189) fitted at a distal end (at 189) of the utility probe (Fig 12 and [0053] disclose a prosthetic valve, which is placed at the distal end of the catheter)
a first sensor, configured to output first signals indicative of first positions of the distal end effector inside the cavity (positioning sensors are mentioned but not shown in the figure, positioned at the distal portions of the catheters (186, 188), corresponding disclosure at least [0053]).
inserting an ultrasound probe into an organ of a body (an ECHO imaging catheter (188) disclosed in [0053] and fig. 11 for insertion into the organ of the body), the ultrasound probe comprising:
an ultrasound transducer array configured to image a volume of the organ, the volume comprising at least a portion of the distal end effector (see ECHO imaging catheter with an ultrasound transducer array as shown in below re-produced fig. 11, which is configured to image a volume (184) and confirm the proper position of the delivery catheter (186). The ECHO imaging catheter (188) also includes electrodes/sensors on the distal end, which is disclosed at least in fig. 8a, 8b, and [0049]).
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and a second sensor configured to output second signals indicative of second positions of the ultrasound transducer array inside the cavity (corresponding disclosure in at least [0042], where multiple position indicators (sensors) are configured for locating the position of the distal end; having multiple sensors would indicate a second position “an EP imaging catheter 50 according to the invention is depicted, with the elongated catheter shaft 52 advanced through the patient's vascular system to position the imaging catheter distal end 54”, and further in [0053], where the ultrasound transducer array, or the ECHO catheter also includes positioning sensors “the positions of the valve delivery catheter 186 and/or ECHO catheter 188 may be provided by the electrophysiological 3D mapping system, such as where the valve delivery catheter 186 and/or ECHO catheter 188 have one or more positioning sensors (not shown) thereon or therein (e.g., sensors positioned at the distal portions of the catheter(s) 186, 188)”).
a processor (88)).
Tuason does not teach using the imaged volume, the first positions, and the second positions, select two or more of slices of the imaged volume that comprise at least part of the distal end effector in spatial relation with the organ, wherein the two or more slices have different orientations. and generating from the one or more selected slices at least one of a biplane (i.e. 2D) view and triplane (i.e. 3D) view of the part of the distal end effector.
Bharat, in a similar field of endeavor, teaches a similar concept (visualization and tracking of probe) of using the imaged volume, the first positions, and the second positions, selecting two or more of slices of the imaged volume that comprise at least part of the distal end effector in spatial relation with the organ, wherein each of the one or more slices corresponds to a planar slice that intersects the distal end effector (corresponding disclosure in at least [0017], where 2 more or more (multiple image slices) are chosen or selected “ choose and re-render two-dimensional (2D) images or image slices to display, so they include real-time tracked tool position(s)” and further in [0042], where based on the positions, an image slice is selected, which includes the view of the instrument used “he interpretation module 45 selects image slices 78, e.g., 2D TRUS/MR image slices to display, so it contains the real-time tracked tool position(s). The interpretation module 45 employs a field of view that includes all or some trackable features (e.g., sensor position, instrument position, biopsy/target location, etc.). Using the positions (e.g., depths), the interpretation module 45 selects an image slice (50) that best defines the relationship between the sensors 22 on the needle 14 and the biopsy location. The interpretation module 45 may select a plane where all trackable positions are present or may select another plane based upon criteria stored in the interpretation module 45 that best shows the relationship. The criteria may include an angle for best viewing internal organs, best viewing the target, best viewing the needle or other instrument, etc.”; and further in [0046] and Figure 3, where the view plane is selected with the slice intersecting, or the in-plane view “ the in-plane positions of two or three reference points are employed to select the view plane. This feature provides a real-time view of the anatomy in the vicinity of the biopsy tool, which can be especially useful during insertion of the tool 204”).
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Figure 3 of Bharat
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated using the imaged volume and position information to select a slice of the image with the distal end effector as taught by Bharat. One of the ordinary skill in the art would have been motivated to incorporate this because the position information of the surgical instrument is more accurately determined and a further image is then generated with the updated view.
Tuason and Bharat do not specify generating from the one or more selected slices at least one of a biplane (i.e. 2D) view and triplane (i.e. 3D) view of the part of the distal end effector.
Rohling, in a similar field of endeavor, teaches a similar concept (visualization of surgical instrument with utlrasound) of generating from the one or more selected slices at least one of a biplane (i.e. 2D) view and triplane (i.e. 3D) view of the part of the distal end effector; and present the at least one of the biplane view and triplane view to a user (corresponding disclosure in at least [0143], where one or more selected slices are used to show a biplane, or 2D view as well as a 3D view of the distal end effector, or the needle, then further displaying the views to the user “the thick slice sagittal image 603 coincides with a plane that is sagittal to the patient and intersects the graphic overlay 1302 of the propagation axis of the medical instrument guide… As the needle 405 is inserted deeper into the tissue, more and more of the needle 405 becomes visible in the image 603. The operator aligns the graphic overlay 1302 of the propagation axis with the target 404 so that subsequent insertion of the needle 405 into tissue reaches the target 404. This image 603 is updated on the image display device as the ultrasound 3-D volumetric dataset is created by probe. In this way, the apparatus provides current images of the needle insertion procedure”, where the 3D image is updated based on the selected slices, which correspond to the needle entry).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated generating from one or more selected slices a biplane and triplane view as taught by Rohling. One of the ordinary skill in the art would have been motivated to incorporate this because the generated view properly represents an updated image during the insertion of the device.
Claims 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Tuason (US 20190060003 A1), Bharat (US20170202625A1) , Rohling (US20160022308A1), and Kruecker (US20170304644A1 as applied in Claim 1 and 10, and in further view of Subramaniam et al. (US 9687166 B2).
Regarding Claim 2 and Claim 11, the combined references noted above teach the limitations of Claim 1, but do not teach wherein the part of the distal end effector comprises one of expandable splines and expandable arms.
Subramaniam, in a similar field of endeavor, teaches a similar concept (catheters) of wherein the part of the distal end effector comprises one of expandable splines and expandable arms (corresponding disclosure in at least Fig. 2 and at least col 5, lines 32-60). The reference goes to further state that “other shapes and/or configurations are contemplated” and various other assemblies can be used (corresponding disclosure in at least col 6, lines 1-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have any configuration at the end of a distal end effector, as taught by Subramaniam. One of ordinary skill in the art would have been motivated to take the idea of having various configurations of a distal end effector based on what is best suited for the use.
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Tuason (US 20190060003 A1), Bharat (US20170202625A1), Rohling (US20160022308A1), and Kruecker (US20170304644A1 as applied in Claim 1 and 10, and in further view of Degertekin (US20160249882A1).
Regarding Claim 4 and Claim 13, the combination noted above teach the limitations of Claims 1 and 10, but do not specify wherein the ultrasound probe is an intracardiac echography (ICE) four-dimensional (4D) ultrasound (US) catheter.
Degertekin, in a similar field of endeavor, teaches a similar concept (catheters) of wherein the device is a single intracardiac echography (ICE) 4D ultrasound (US) catheter (corresponding disclosure in at least [0013], where an ICE catheter is used for 4D imaging “Therefore the CMUT-on-CMOS approach, along with innovative on-chip beamforming and massive multiplexing, provides a unique platform for full-volume real-time 3D ICE”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a 4D ultrasound catheter during medical procedures for high resolution real-time imaging, as taught by Degertekin. One of ordinary skill in the art would have been motivated to use this system because of the inaccuracies that can be seen with current inventions and the complexities of organs (i.e. the heart), leading to inefficiency and complications.
Response to Arguments
Applicant’s arguments with respect to claim 1 has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments with respect to claims 1-18 under 35 U.S.C. 103 have been considered but are not persuasive. Regarding Claim 10, Applicant argues Bharat does not teach “selecting two or more slices of the imaged volume” and “wherein the two or more slices have different orientations”. However, [0017] of Bharat states choosing image slices, referring to multiple images, to represent the tracked tool. Or the distal end effector. Bharat further discloses in [0042] where the slices are displayed and selected according to different positions and orientations of the needle “The interpretation module 45 may be employed to interpret a tracked 3D image volume 76 to determine a position and orientation of the biopsy tool or needle 14 with respect to a current image slice or image 78. The interpretation module 45 selects image slices 78, e.g., 2D TRUS/MR image slices to display, so it contains the real-time tracked tool position(s)”).
All other claims are rejected due to their dependency to the rejected independent claims.
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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/K.E.K./Examiner, Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
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