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
This Office Action is responsive to the claims filed on 07/01/2026. Claims 1, 4, 6, 11, and 16 have been amended. Claims 1-20 are presently 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.
Claims 1-3, 5, 6, 9-13, 15, 16, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Altmann (US 20090148012) in view of Moll (US 20070156123 A1) and Harlev (US 20170330487 A1).
Regarding claim 1, Altmann teaches a system (Paragraph [0016]; systems for modeling a three-dimensional (3-D) anatomical structure, Fig. 1), comprising:
a display (Paragraph [0073]; display #34, Fig. 1), which is configured to display multiple pixels (Paragraphs [0072]; reconstruct a 3-D ultrasound image in a 3-D space, comprising a set of voxels (i.e., 3-D pixels); displays 3-D objects, Fig. 4B) of an image (Paragraphs [0072], [0073], and [0081]; 3-D ultrasound image, Fig. 4B) of an organ having a cavity (Paragraph [0067]; body cavity, heart; Fig. 4A) and tissue surrounding the cavity (Paragraphs [0067], [0079], and [0081]; tissue, inner surface of the wall); and
a processor (Paragraphs [0071]-[0074]; processors #30 and 32, Fig. 1), which is configured to:
receive an ultrasound (US) signal (Paragraph [0072]; Image processor #32 typically receives the ultrasound-related signals) of at least the cavity and the tissue (Paragraph [0081]; physician manipulates catheter #24 to acquire ultrasound image data… corresponding to at least three anatomical structures: a chamber of a heart… a wall, typically having distinct inner and outer surfaces… and, an external volume) and one or more position signals (Paragraph [0078]; Position sensor #42… used by positioning processor #30 to derive the coordinates of the ultrasound sensor #44) in the organ indicative of one or more positions of one or more catheters (Paragraph [0075]; The catheter comprises a position sensor #42, Fig. 2), respectively;
and based on the one or more position signals, and the US signal:
(i) identify in the image a given pixel at a given position (Paragraph [0110]; each contour surface point may be highlighted according to the value of the corresponding voxel … after registering coordinates of these images with the contour using image registration methods known in the art), and
(ii) display the given pixel (Paragraph [0094] and [0105]; display image data (i.e., voxels); 2-D slices of the ultrasound image) as:
(a) a first pixel indicative of the cavity (Paragraphs [0095] and [0115]; voxels corresponding to unobstructed body cavities appear transparent) responsively to identifying that the given position corresponds to the one or more positions (Paragraphs [0103] and [0115]; an edge detection algorithm is implemented to detect a contour corresponding to the inner wall surface… Contour points are detected when the detection rays intersect sets of voxels with intensity variations that match a threshold, Fig. 4E; Examiner notes the process of detecting the voxel within a set of rays around a seed point is considered to read on the claimed limitation of identifying that the given position corresponds to the one or more positions in its broadest reasonable interpretation), or
(b) a second pixel indicative of the tissue (Paragraphs [0095] and [0115]; voxels corresponding to tissues or other obstructions appear relatively dark and opaque).
Examiner notes that Altmann teaches the position sensor #42 is located adjacent to electrode #48 and to ultrasound sensor #44 with a position offset (Paragraph [0078]); and using the position offset for identifying and displaying the given pixel (Paragraph [0078]; used by positioning processor #30 to derive the coordinates of the ultrasound sensor #44).
It is unclear if Altmann teaches the catheter has a known geometry, wherein the known geometry comprises physical dimensions accessible to the processor prior to use of the one or more catheters;
and using the known geometry for identifying the given pixel and displaying the given pixel;
and further classify the given pixel as physically reachable or unreachable by a distal end of the one or more catheters based on geometric constraints of the one or more catheters within the cavity, wherein a given pixel corresponding to a position visited by the distal end is classified as the first pixel indicative of the cavity.
Moll, however, teaches the catheter has a known geometry, wherein the known geometry comprises physical dimensions accessible to the processor prior to use of the one or more catheters (Paragraph [0057]; a model may be created without a localization sensor utilizing another mode of position determination, such as the kinematics and mechanics of the known instrument system; Paragraph [0063]; Knowledge of the kinematics and mechanics of the instrument system; paragraph [0068]; a first kinematic model may be passed to, or triggered from memory within, the localization system… while the instrument is in such first space may comprise merely tip position information);
and using the known geometry for identifying the given pixel and displaying the given pixel (Paragraph [0070]; a relative position of a sheath instrument in a body, and known kinematic relationships of the instrument system, in certain embodiments it is desirable to run software algorhythms to determine a "reachability" of potential destination points of interest to the system operator. By way of example, using a triangular heart mesh model, the system may analyze the reachability of the vertex point of every triangle on the model.; Paragraph [0072]; if a collision is required for the instrument to reach a desired endpoint given the analysis of the segments, the location of such desired endpoint may be assigned a color designated to have a certain meaning to the operator);
and further classify the given pixel as physically reachable or unreachable (Paragraph [0070]; it is desirable to run software algorhythms to determine a "reachability" of potential destination points of interest to the system operator… analyze the reachability of the vertex point of every triangle on the model… with location zones having a green/yellow/red coloring scheme applied on a display to indicate the degree of reachability of each zone) by a distal end of the one or more catheters (Paragraph [0071]; reachability analysis may be utilized to determine, for example, whether the body of the instrument proximal to the distal tip may become hung up into tissue or some other nearby structure) based on geometric constraints of the one or more catheters within the cavity (Paragraph [0071]; instrument will get hung up… analyzed as a series of segments, with collision detection algorithms being run for each discrete portion of the instrument body (as positioned by the desired tip location and kinematics/mechanics) and the tissue structure mesh).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Altmann to have known the catheter geometry, wherein the known geometry comprises physical dimensions accessible to the processor prior to use of the one or more catheters; and further use the known geometry for identifying the given pixel and displaying the given pixel; and further classify the given pixel as physically reachable or unreachable by a distal end of the one or more catheters based on geometric constraints of the one or more catheters within the cavity as taught by Moll. By having a known the catheter geometry, would have been able to model the location of the catheter without the need of a localization sensor by using the kinematics and the mechanics of the instrument and further use the movement of the distal tip of the instrument, and detection of contact with surrounding tissues utilizing for inner surface mapping (Paragraph [0057]). Furthermore, classifying the given pixel as physically reachable or unreachable would have allowed optimally guiding an instrument to a portion of anatomy for performing a surgical operation (Paragraph [0064]) and further improve the safety in navigation by detecting where a collision can occur or is required (Paragraph [0072]).
Together Altmann and Moll does not teach a given pixel corresponding to a position visited by the distal end is classified as the first pixel indicative of the cavity.
Harlev, however, teaches a system (Paragraph [0004]; systems, and methods of controlling the construction of a three-dimensional model of a cardiac chamber) comprising:
a processor (Paragraph [0039]; include a processing unit 109 (e.g., one or more processors); Fig. 1), which is configured to: based on the one or more position signals (Paragraph [0040]; and the processing unit 109 can receive a plurality of location signals of the catheter 104 in the cardiac chamber), the known geometry (Paragraph [0047]; Accordingly, because the tip section 124 is coupled to the distal portion 128 of the shaft 122 in a known, fixed relationship to the magnetic position sensor 130, the magnetic position sensor 130 also provides the location of the tip section 124.):
identify in the image a given pixel at a given position (Paragraph [0053]-[0054]; it may be desirable to project both the three-dimensional data structure 134 and the continuous surface 136 onto the viewing window 138 during the build phase to facilitate editing the three-dimensional data structure 134 and, thus, facilitate editing of the continuous surface 136 according to any one or more of the various different methods described herein; Each voxel 135 can be a discrete element of volume corresponding to an analogous volume in the cardiac chamber… each voxel 135 of the three-dimensional data structure indicated as “visited” can have one or more indications of chronological order associated with it.), wherein a given pixel corresponding to a position visited by the distal end (Paragraph [0054]; Thus, as a tip section of a catheter (e.g., the tip section 124 of the catheter 104 in FIGS. 2 and 3) visits a location in the cardiac chamber) is classified as the first pixel indicative of the cavity (Paragraph [0054]; the corresponding one of the voxels 135 can be flagged or otherwise indicated as “visited.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Altmann and Moll such that a given pixel corresponding to a position visited by the distal end is classified as the first pixel indicative of the cavity as taught by Harlev because it would have better allowed mapping a continuous surface of the cardiac chamber based on a chronological order of the visited locations of the catheter in the cardiac chamber and thus improve the representation of the locations in the cardiac chamber (Paragraphs [0011] and [0040]). Furthermore, it would be useful for forming representations of the cardiac chamber during diagnosis or treatment (Paragraph [0053]).
Regarding claim 2, together Altmann, Moll, and Harlev teach all of the limitations of claim 1 as noted above. Altmann further teaches the multiple pixels, the given pixel, and the first and second pixels comprise volumetric pixels (voxels) (Paragraph [0072]; reconstruct a 3-D ultrasound image in a 3-D space, comprising a set of voxels (i.e., 3-D pixels)).
Regarding claim 3, together Altmann, Moll, and Harlev teach all of the limitations of claim 1 as noted above. Altmann further teaches the processor is configured to assign a first color to the first pixel (Paragraphs [0093], [0095], and [0115]; voxels corresponding to unobstructed body cavities appear transparent; Highlighting may be indicated by various means, such as coloring or shading) and a second color to the second pixel, different from the first color (Paragraphs [0093], [0095], and [0115]; voxels corresponding to tissues or other obstructions appear relatively dark and opaque; Highlighting may be indicated by various means, such as coloring or shading).
Examiner considers the transparent and dark/opaque shading to be two different colors. If the colors are not different, it would have been obvious to have modified the shadings such that the colors are different as it would allow indicating the difference between the two types of pixels (Altmann, Paragraph [0093]).
Regarding claim 5, together Altmann, Moll, and Harlev teach all of the limitations of claim 1 as noted above. Altmann further teaches the one or more catheters comprise one or both of: (i) a mapping catheter configured to sense electrical signals in the tissue (Paragraph [0068]; catheter #24 is a position-sensing, ultrasound probe, which is configured to perform functions that include anatomical mapping and ultrasound imaging), and
(ii) an ablation catheter configured to apply ablation signals to the tissue (Paragraph [0116]; The 3-D model may also be used in conjunction with other diagnostic or surgical tools, such as ablation catheters).
Regarding claim 6, together Altmann, Moll, and Harlev teach all of the limitations of claim 1 as noted above. Altmann further teaches at least a catheter among the catheters (Paragraph [0075]; catheter #24, Fig. 2) comprising a distal end (Paragraph [0075]; shows the distal end of catheter #24, Fig. 2) having the known geometry and comprising ultrasound transducers (UT) configured to apply US waves to the organ and to produce the US signal (Paragraphs [0071] and [0075]; The catheter comprises an ultrasonic sensor #44; an ultrasound sensor that generates ultrasound energy and receives reflected ultrasound echoes; the ultrasound sensor transmits ultrasound-related signals to an image processor #32, Fig. 2) at a respective position of the distal end (Paragraphs [0071] and [0072]; the ultrasound-related signals from multiple positions and orientations of the ultrasound sensor).
Regarding claim 9, together Altmann, Moll, and Harlev teach all of the limitations of claim 6 as noted above. Altmann further teaches when the distal end is moved within the cavity between a first position and a second position (Paragraphs [0080]-[0083] and [0096]-[0098]; The anatomical map data may be acquired by contact mapping, such as electro-anatomical mapping, in which the catheter is brought into contact with multiple points on the inner surface of the wall, Fig. 3; Examiner notes the process #50 is repeated iteratively for multiple points), different from the first position, the processor is configured to receive: (i) first and second position signals indicative of the first and second positions (Paragraphs [0083] and [0096]-[0098]; The image processor automatically generates from the anatomical map one or more seed points. A seed point may be a particular point comprised in the map, or may be determined by interpolation and/or extrapolation from several measured points, Fig. 3), respectively, and (ii) first and second US signals indicative of the cavity at the first and second positions (Paragraphs [0080]-[0083] and [0096]-[0098]; the physician manipulates catheter #24 to acquire ultrasound image data and anatomical map data of a target structure… corresponding to an internal volume such as a chamber, Fig. 3; Examiner notes process #50 is repeated iteratively, thus at least one US signal is acquired for each point), respectively, and, based on the first and second position signals and US signals, to present on the display at least first and second US images of the first and second positions, respectively (Paragraphs [0087]-[0094] and [0096]-[0098]; The output of step #56 is… one or more contours that segment the original ultrasound 3-D image; the contour may be applied in subsequent steps of visualizing the ultrasound image; Each point of the contour surface may be highlighted according to the value of the voxel at the corresponding coordinates in the 3-D image; Fig. 3; Examiner notes the process #50 is repeated iteratively, resulting in an image for each point).
Regarding claim 10, together Altmann, Moll, and Harlev teach all of the limitations of claim 9 as noted above. Altmann further teaches the first and second US images comprise first and second three-dimensional (3D) US images, respectively (Paragraphs [0092]-[0098]; The picture is generally displayed as a 3-D image using 3-D visualization methods, including projection of 3-D data onto the 2-D plane of the console display, Figs. 3 and 6-8).
Regarding claim 11, Altmann teaches a method (Paragraph [0016]; methods for modeling a three-dimensional (3-D) anatomical structure, Fig. 1), comprising:
displaying multiple pixels (Paragraphs [0072]; reconstruct a 3-D ultrasound image in a 3-D space, comprising a set of voxels (i.e., 3-D pixels); displays 3-D objects, Fig. 4B) of an image (Paragraphs [0072], [0073], and [0081]; 3-D ultrasound image, Fig. 4B) of an organ having a cavity (Paragraph [0067]; body cavity, heart; Fig. 4A) and tissue surrounding the cavity (Paragraphs [0067], [0079], and [0081]; tissue, inner surface of the wall);
receiving an ultrasound (US) signal (Paragraph [0072]; Image processor #32 typically receives the ultrasound-related signals) of at least the cavity and the tissue (Paragraph [0081]; physician manipulates catheter #24 to acquire ultrasound image data… corresponding to at least three anatomical structures: a chamber of a heart… a wall, typically having distinct inner and outer surfaces… and, an external volume) and one or more position signals (Paragraph [0078]; Position sensor #42… used by positioning processor #30 to derive the coordinates of the ultrasound sensor #44) in the organ indicative of one or more positions of one or more catheters (Paragraph [0075]; The catheter comprises a position sensor #42, Fig. 2), respectively; and
based on the one or more position signals, and the US signal:
(i) identifying in the image a given pixel at a given position (Paragraph [0110]; each contour surface point may be highlighted according to the value of the corresponding voxel … after registering coordinates of these images with the contour using image registration methods known in the art),
and (ii) displaying the given pixel (Paragraph [0094] and [0105]; display image data (i.e., voxels); 2-D slices of the ultrasound image) as:
(a) a first pixel indicative of the cavity (Paragraphs [0095] and [0115]; voxels corresponding to unobstructed body cavities appear transparent) responsively to identifying that the given position corresponds to the one or more positions (Paragraphs [0103] and [0115]; an edge detection algorithm is implemented to detect a contour corresponding to the inner wall surface… Contour points are detected when the detection rays intersect sets of voxels with intensity variations that match a threshold, Fig. 4E; Examiner notes the process of detecting the voxel within a set of rays around a seed point is considered to read on the claimed limitation of identifying that the given position corresponds to the one or more positions in its broadest reasonable interpretation), or
(b) a second pixel indicative of the tissue (Paragraphs [0095] and [0115]; voxels corresponding to tissues or other obstructions appear relatively dark and opaque).
Examiner notes that Altmann teaches the position sensor #42 is located adjacent to electrode #48 and to ultrasound sensor #44 with a position offset (Paragraph [0078]); and using the position offset for identifying and displaying the given pixel (Paragraph [0078]; used by positioning processor #30 to derive the coordinates of the ultrasound sensor #44).
It is unclear if Altmann teaches the catheter has a known geometry, wherein the known geometry comprises physical dimensions accessible to the processor prior to use of the one or more catheters;
and using the known geometry for identifying the given pixel and displaying the given pixel;
and further classify the given pixel as physically reachable or unreachable by a distal end of the one or more catheters based on geometric constraints of the one or more catheters within the cavity, wherein a given pixel corresponding to a position visited by the distal end is classified as the first pixel indicative of the cavity.
Moll, however, teaches the catheter has a known geometry, wherein the known geometry comprises physical dimensions accessible to the processor prior to use of the one or more catheters (Paragraph [0057]; a model may be created without a localization sensor utilizing another mode of position determination, such as the kinematics and mechanics of the known instrument system; Paragraph [0063]; Knowledge of the kinematics and mechanics of the instrument system; paragraph [0068]; a first kinematic model may be passed to, or triggered from memory within, the localization system… while the instrument is in such first space may comprise merely tip position information);
and using the known geometry for identifying the given pixel and displaying the given pixel (Paragraph [0070]; a relative position of a sheath instrument in a body, and known kinematic relationships of the instrument system, in certain embodiments it is desirable to run software algorhythms to determine a "reachability" of potential destination points of interest to the system operator. By way of example, using a triangular heart mesh model, the system may analyze the reachability of the vertex point of every triangle on the model.; Paragraph [0072]; if a collision is required for the instrument to reach a desired endpoint given the analysis of the segments, the location of such desired endpoint may be assigned a color designated to have a certain meaning to the operator);
and further classify the given pixel as physically reachable or unreachable (Paragraph [0070]; it is desirable to run software algorhythms to determine a "reachability" of potential destination points of interest to the system operator… analyze the reachability of the vertex point of every triangle on the model… with location zones having a green/yellow/red coloring scheme applied on a display to indicate the degree of reachability of each zone) by a distal end of the one or more catheters (Paragraph [0071]; reachability analysis may be utilized to determine, for example, whether the body of the instrument proximal to the distal tip may become hung up into tissue or some other nearby structure) based on geometric constraints of the one or more catheters within the cavity (Paragraph [0071]; instrument will get hung up… analyzed as a series of segments, with collision detection algorithms being run for each discrete portion of the instrument body (as positioned by the desired tip location and kinematics/mechanics) and the tissue structure mesh).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Altmann to have known the catheter geometry, wherein the known geometry comprises physical dimensions accessible to the processor prior to use of the one or more catheters; and further use the known geometry for identifying the given pixel and displaying the given pixel; and further classify the given pixel as physically reachable or unreachable by a distal end of the one or more catheters based on geometric constraints of the one or more catheters within the cavity as taught by Moll. By having a known the catheter geometry, would have been able to model the location of the catheter without the need of a localization sensor by using the kinematics and the mechanics of the instrument and further use the movement of the distal tip of the instrument, and detection of contact with surrounding tissues utilizing for inner surface mapping (Paragraph [0057]). Furthermore, classifying the given pixel as physically reachable or unreachable would have allowed optimally guiding an instrument to a portion of anatomy for performing a surgical operation (Paragraph [0064]) and further improve the safety in navigation by detecting where a collision can occur or is required (Paragraph [0072]).
Together Altmann and Moll does not teach a given pixel corresponding to a position visited by the distal end is classified as the first pixel indicative of the cavity.
Harlev, however, teaches a method (Paragraph [0004]; systems, and methods of controlling the construction of a three-dimensional model of a cardiac chamber) comprising:
based on the one or more position signals (Paragraph [0040]; and the processing unit 109 can receive a plurality of location signals of the catheter 104 in the cardiac chamber), the known geometry (Paragraph [0047]; Accordingly, because the tip section 124 is coupled to the distal portion 128 of the shaft 122 in a known, fixed relationship to the magnetic position sensor 130, the magnetic position sensor 130 also provides the location of the tip section 124.):
identifying in the image a given pixel at a given position (Paragraph [0053]-[0054]; it may be desirable to project both the three-dimensional data structure 134 and the continuous surface 136 onto the viewing window 138 during the build phase to facilitate editing the three-dimensional data structure 134 and, thus, facilitate editing of the continuous surface 136 according to any one or more of the various different methods described herein; Each voxel 135 can be a discrete element of volume corresponding to an analogous volume in the cardiac chamber… each voxel 135 of the three-dimensional data structure indicated as “visited” can have one or more indications of chronological order associated with it.), wherein a given pixel corresponding to a position visited by the distal end (Paragraph [0054]; Thus, as a tip section of a catheter (e.g., the tip section 124 of the catheter 104 in FIGS. 2 and 3) visits a location in the cardiac chamber) is classified as the first pixel indicative of the cavity (Paragraph [0054]; the corresponding one of the voxels 135 can be flagged or otherwise indicated as “visited.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Altmann and Moll such that a given pixel corresponding to a position visited by the distal end is classified as the first pixel indicative of the cavity as taught by Harlev because it would have better allowed mapping a continuous surface of the cardiac chamber based on a chronological order of the visited locations of the catheter in the cardiac chamber and thus improve the representation of the locations in the cardiac chamber (Paragraphs [0011] and [0040]). Furthermore, it would be useful for forming representations of the cardiac chamber during diagnosis or treatment (Paragraph [0053]).
Regarding claim 12, together Altmann, Moll, and Harlev teach all of the limitations of claim 11 as noted above. Altmann further teaches the multiple pixels, the given pixel, and the first and second pixels comprise volumetric pixels (voxels) (Paragraph [0072]; reconstruct a 3-D ultrasound image in a 3-D space, comprising a set of voxels (i.e., 3-D pixels)).
Regarding claim 13, together Altmann, Moll, and Harlev teach all of the limitations of claim 11 as noted above. Altmann further teaches displaying the image comprises assigning a first color to the first pixel (Paragraphs [0093], [0095], and [0115]; voxels corresponding to unobstructed body cavities appear transparent; Highlighting may be indicated by various means, such as coloring or shading) and a second color to the second pixel, different from the first color (Paragraphs [0093], [0095], and [0115]; voxels corresponding to tissues or other obstructions appear relatively dark and opaque; Highlighting may be indicated by various means, such as coloring or shading).
Examiner considers the transparent and dark/opaque shading to be two different colors. If the colors are not different, it would have been obvious to have modified the shadings such that the colors are different as it would allow indicating the difference between the two types of pixels (Altmann, Paragraph [0093]).
Regarding claim 15, together Altmann, Moll, and Harlev teach all of the limitations of claim 11 as noted above. Altmann further teaches the one or more catheters comprise one or both of: (i) a mapping catheter configured to sense electrical signals in the tissue (Paragraph [0068]; catheter #24 is a position-sensing, ultrasound probe, which is configured to perform functions that include anatomical mapping and ultrasound imaging), and
(ii) a ablation catheter configured to apply ablation signals to the tissue (Paragraph [0116]; The 3-D model may also be used in conjunction with other diagnostic or surgical tools, such as ablation catheters).
Regarding claim 16, together Altmann, Moll, and Harlev teach all of the limitations of claim 11 as noted above. Altmann further teaches at least a catheter among the catheters (Paragraph [0075]; catheter #24, Fig. 2) comprising a distal end (Paragraph [0075]; shows the distal end of catheter #24, Fig. 2) having the known geometry and comprising ultrasound transducers (UT) for applying US waves to the organ and producing the US signal (Paragraphs [0071] and [0075]; The catheter comprises an ultrasonic sensor #44; an ultrasound sensor that generates ultrasound energy and receives reflected ultrasound echoes; the ultrasound sensor transmits ultrasound-related signals to an image processor #32, Fig. 2) at a respective position of the distal end (Paragraphs [0071] and [0072]; the ultrasound-related signals from multiple positions and orientations of the ultrasound sensor).
Regarding claim 19, together Altmann, Moll, and Harlev teach all of the limitations of claim 16 as noted above. Altmann further teaches when the distal end is moved within the cavity between a first position and a second position (Paragraphs [0080]-[0083] and [0096]-[0098]; The anatomical map data may be acquired by contact mapping, such as electro-anatomical mapping, in which the catheter is brought into contact with multiple points on the inner surface of the wall, Fig. 3; Examiner notes the process #50 is repeated iteratively for multiple points), different from the first position, receiving: (i) first and second position signals indicative of the first and second positions (Paragraphs [0083] and [0096]-[0098]; The image processor automatically generates from the anatomical map one or more seed points. A seed point may be a particular point comprised in the map, or may be determined by interpolation and/or extrapolation from several measured points, Fig. 3), respectively, and (ii) first and second US signals indicative of the cavity at the first and second positions (Paragraphs [0080]-[0083] and [0096]-[0098]; the physician manipulates catheter #24 to acquire ultrasound image data and anatomical map data of a target structure… corresponding to an internal volume such as a chamber, Fig. 3; Examiner notes process #50 is repeated iteratively, thus at least one US signal is acquired for each point), respectively, and, based on the first and second position signals and US signals, presenting on the display at least first and second US images of the first and second positions, respectively (Paragraphs [0087]-[0094] and [0096]-[0098]; The output of step #56 is… one or more contours that segment the original ultrasound 3-D image; the contour may be applied in subsequent steps of visualizing the ultrasound image; Each point of the contour surface may be highlighted according to the value of the voxel at the corresponding coordinates in the 3-D image; Fig. 3; Examiner notes the process #50 is repeated iteratively, resulting in an image for each point).
Regarding claim 20, together Altmann, Moll, and Harlev teach all of the limitations of claim 19 as noted above. Altmann further teaches the first and second US images comprise first and second three-dimensional (3D) US images, respectively (Paragraphs [0092]-[0098]; The picture is generally displayed as a 3-D image using 3-D visualization methods, including projection of 3-D data onto the 2-D plane of the console display, Figs. 3 and 6-8).
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Altmann in view of Moll and Harlev as applied to claim 3 and 13 above, respectively, and further in view of Fabro (US 20100185172).
Regarding claim 4, together Altmann, Moll, and Harlev teach all of the limitations of claim 3 as noted above.
The system of Altmann in view of Moll and Harlev does not explicitly teach that in response to identifying that a distal end of one of the catheters fails to reach an additional position, the processor is configured to identify an additional pixel, which corresponds to the additional position, and to assign the second color to the additional pixel.
Fabro, however, teaches a system (Paragraph [0009]; Described here are devices and kits that involve assessing the accessibility and/or geometry of a subvalvular space of a heart) comprising a catheter (Paragraph [0146]; diagnostic catheter, Fig. 3 #300) wherein in response to identifying that a distal end of one of the catheters (Paragraphs [0010]-[0012] and [0146]-[0151]; the distal portion of a catheter to visualize the subannular groove) fails to reach an additional position (Paragraphs [0022], [0023], [0119], and [0187]; In some cases in which the subvalvular space is deemed inaccessible), the processor is configured to identify an additional pixel (Paragraphs [0137] and [0181]-[0183]; As shown there, this illustrative method comprises verifying the accessibility of a subannular groove region; Examiner notes the region of the subannular grove region comprises at least an additional pixel, Figs. 2B, 7 and 8), which corresponds to the additional position, and to assign the second color to the additional pixel (Paragraphs [0186]-[0188]; Then, the distribution pattern or patterns may be used to visualize a location and/or orientation of an implant (e.g., an anchor) relative to the subannular groove region; that portion of the implant may be located in a region that is inaccessible by the streak (e.g., embedded into a ventricular wall or located outside of the subannular groove). Any suitable implant or combination of implants having sufficient radiopacity may be viewed in this way).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Altmann in view of Moll and Harlev to further, when in response to identifying that a distal end of one of the catheters fails to reach an additional position, configure the processor to identify an additional pixel, which corresponds to the additional position, and to assign the second color to the additional pixel. This would have allowed an operator to determine if a region is accessible for a larger catheter and if can be made accessible by cutting the chords during an operation (Fabro, Paragraphs [0022], [0023], and [0119]).
Regarding claim 14, together Altmann, Moll, and Harlev teach all of the limitations of claim 13 as noted above.
The method of Altmann in view of Moll and Harlev does not explicitly teach that in response to identifying that the distal end fails to reach an additional position, the processor is configured to identify an additional pixel, which corresponds to the additional position, and to assign the second color to the additional pixel.
Fabro, however, teaches a method (Paragraph [0009]; Described here are methods that involve assessing the accessibility and/or geometry of a subvalvular space of a heart) wherein in response to identifying that the distal end (Paragraphs [0010]-[0012] and [0146]-[0151]; the distal portion of a catheter to visualize the subannular groove) fails to reach an additional position (Paragraphs [0022], [0023], [0119], and [0187]; In some cases in which the subvalvular space is deemed inaccessible), the processor is configured to identify an additional pixel (Paragraphs [0137] and [0181]-[0183]; As shown there, this illustrative method comprises verifying the accessibility of a subannular groove region; Examiner notes the region of the subannular grove region comprises at least an additional pixel, Figs. 2B, 7 and 8), which corresponds to the additional position, and to assign the second color to the additional pixel (Paragraphs [0186]-[0188]; Then, the distribution pattern or patterns may be used to visualize a location and/or orientation of an implant (e.g., an anchor) relative to the subannular groove region; that portion of the implant may be located in a region that is inaccessible by the streak (e.g., embedded into a ventricular wall or located outside of the subannular groove). Any suitable implant or combination of implants having sufficient radiopacity may be viewed in this way).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Altmann in view of Moll and Harlev to further, when in response to identifying that a distal end of one of the catheters fails to reach an additional position, configure the processor to identify an additional pixel, which corresponds to the additional position, and to assign the second color to the additional pixel. This would have allowed an operator to determine if a region is accessible for a larger catheter and if can be made accessible by cutting the chords during an operation (Fabro, Paragraphs [0022], [0023], and [0119]).
Claims 7, 8, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Altmann in view of Moll and Harlev as applied to claims 6 and 16 above, respectively, and further in view of Barbagli (US 20080119727).
Regarding claim 7, together Altmann, Moll, and Harlev teach all of the limitations of claim 6 as noted above. Altmann further teaches the position sensor is coupled to the distal end at a known location relative to the 2D array (Paragraphs [0070], [0071], and [0075]; FIG. 2 is a schematic, pictorial illustration that shows the distal end of catheter #24; Examiner notes the position sensor #42 is distal to the ultrasonic sensor #44 as shown in Fig. 2).
The system of Altmann in view of Moll and Harlev does not teach the catheter comprises a four-dimensional (4D) ultrasound catheter, wherein the UT are arranged in a two-dimensional (2D) array at the distal end.
Barbagli, however, teaches a system (Paragraph [0002] and [0004]; systems for producing three-dimensional maps or models of body cavities) comprising a catheter (Paragraphs [0043]-[0053]; catheter, guide instrument, Fig. 4H #412) wherein the catheter comprises a four-dimensional (4D) ultrasound catheter (Paragraph [0051]; data may be acquired throughout a given sampling period of time for later analysis versus time to produce two or three dimensional images versus time, somewhat like a movie (sometimes referred to as "4-D" ultrasound imaging--or 3-D ultrasound versus time)), wherein the UT are arranged in a two-dimensional (2D) array at the distal end (Paragraph [0047]; two-dimensional matrix configuration, Fig. 4H #420), and where the position sensor is coupled to the distal end at a known location relative to the 2D array (Paragraph [0044]; locational sensor #422; Localization sensors #433 are configured to provide three-dimensional location data (i.e., X, Y, Z coordinates)… for the sensor location as coupled to the pertinent instrument (e.g., #410, #412). Tt is desirable in one embodiment to also have a localization device #422 coupled to the ultrasound catheter, Fig. 4H).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Altmann in view of Moll and Harlev such that the catheter comprises a four-dimensional (4D) ultrasound catheter, wherein the UT are arranged in a two-dimensional (2D) array at the distal end as this would allow acquisition of real-time images which allows the operator to avoid certain nerve bundles or other structures when navigating near critical structures (Barbagli, Paragraph [0112]).
Regarding claim 8, together Altmann, Moll, Harlev and Barbagli teach all of the limitations of claim 7 as noted above. Together Altmann and Barbagli further teach the processor is configured to calibrate between a first coordinate system of the 2D array and a second coordinate system of the position sensor (Altmann, Paragraph [0078]; Typically, positional and orientational offsets between position sensor #42, electrode #48, and ultrasound sensor #44 are constant and are used by positioning processor #30 to derive the coordinates of the ultrasound sensor #44 and of electrode #48. In some embodiments, the offsets are pre-calibrated and stored in positioning processor #30. Alternatively, the offsets may be stored in a memory device coupled to catheter #24; Barbagli, Paragraphs [0044], [0192], and claim 22), and to identify the given pixel in the image based on the calibrated first and second coordinate systems (Altmann, Paragraphs [0092] and [0110]; a picture of the enhanced map, including coordinates of the extracted contour points, is displayed. Physiological parameters may be estimated for the added contour points by interpolating and/or extrapolating parameter values from the original map data; Barbagli, Paragraphs [0174]-[0180]).
Moll further teaches teach the processor is configured to calibrate between a first coordinate system of the 2D array and a second coordinate system of the position sensor (Paragraph [0079]-[0084]; relative positions of the reference transducers and therefore to establish a three-dimensional coordinate system; Paragraph [0074]; establish a three-dimensional coordinate system within a patient's heart. The system allows the positions of one or more additional catheters 12, 14, 16, to be represented graphically on a graphical user interface 124 relative to a coordinate system; extrapolate catheter position from the coordinates of the transducer locations based on models of the various catheters pre-programmed into the system… their distal tips, their electrodes or ablation sections, if any, or other sections which may be of interest; The translation of a coordinates from the model to the coordinate system established by the ultrasound system is considered to read on the claimed limitation of calibrate between a first coordinate system of the 2D array and a second coordinate system of the position sensor as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Altmann in view of Moll, Harlev, and Barbagli to calibrate between a first coordinate system of the 2D array and a second coordinate system because it would have allowed identification of the locations of anatomical landmarks (such as the septal wall) relative to the coordinate system based on both the ultrasound measurements and from other references (Moll, Paragraph [0183]) and ensured contours are transformed in the 3-D coordinate space to align with the points in the electro-anatomical map (Altmann, Paragraph [0089]).
Regarding claim 17, together Altmann, Moll, and Harlev teach all of the limitations of claim 16 as noted above. Altmann further teaches the position sensor is coupled to the distal end at a known location relative to the 2D array (Paragraphs [0070], [0071], and [0075]; FIG. 2 is a schematic, pictorial illustration that shows the distal end of catheter #24; Examiner notes the position sensor #42 is distal to the ultrasonic sensor #44 as shown in Fig. 2).
The method of Altmann in view of Moll and Harlev does not teach the catheter comprises a four-dimensional (4D) ultrasound catheter, wherein the UT are arranged in a two-dimensional (2D) array at the distal end.
Barbagli, however, teaches a method (Paragraphs [0002] and [0004]; methods for producing three-dimensional maps or models of body cavities) comprising a catheter (Paragraphs [0043]-[0053]; catheter, guide instrument, Fig. 4H #412) wherein the catheter comprises a four-dimensional (4D) ultrasound catheter (Paragraph [0051]; data may be acquired throughout a given sampling period of time for later analysis versus time to produce two or three dimensional images versus time, somewhat like a movie (sometimes referred to as "4-D" ultrasound imaging--or 3-D ultrasound versus time)), wherein the UT are arranged in a two-dimensional (2D) array at the distal end (Paragraph [0047]; two-dimensional matrix configuration, Fig. 4H #420), and where the position sensor is coupled to the distal end at a known location relative to the 2D array (Paragraph [0044]; locational sensor #422; Localization sensors #433 are configured to provide three-dimensional location data (i.e., X, Y, Z coordinates)… for the sensor location as coupled to the pertinent instrument (e.g., #410, #412). Tt is desirable in one embodiment to also have a localization device #422 coupled to the ultrasound catheter, Fig. 4H).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Altmann in view of Moll and Harlev such that the catheter comprises a four-dimensional (4D) ultrasound catheter, wherein the UT are arranged in a two-dimensional (2D) array at the distal end as this would allow acquisition of real-time images which allows the operator to avoid certain nerve bundles or other structures when navigating near critical structures (Barbagli, Paragraph [0112]).
Regarding claim 18, together Altmann, Moll, Harlev, and Barbagli teach all of the limitations of claim 17 as noted above. Together Altmann and Barbagli further teach calibrating between a first coordinate system of the 2D array and a second coordinate system of the position sensor (Altmann, Paragraph [0078]; Typically, positional and orientational offsets between position sensor #42, electrode #48, and ultrasound sensor #44 are constant and are used by positioning processor #30 to derive the coordinates of the ultrasound sensor #44 and of electrode #48. In some embodiments, the offsets are pre-calibrated and stored in positioning processor #30. Alternatively, the offsets may be stored in a memory device coupled to catheter #24; Barbagli, Paragraphs [0044], [0192], and claim 22), and
identifying the given pixel in the image based on the calibrated first and second coordinate systems (Altmann, Paragraphs [0092] and [0110]; a picture of the enhanced map, including coordinates of the extracted contour points, is displayed. Physiological parameters may be estimated for the added contour points by interpolating and/or extrapolating parameter values from the original map data; Barbagli, Paragraphs [0174]-[0180]).
Moll further teaches teach the processor is configured to calibrate between a first coordinate system of the 2D array and a second coordinate system of the position sensor (Paragraph [0079]-[0084]; relative positions of the reference transducers and therefore to establish a three-dimensional coordinate system; Paragraph [0074]; establish a three-dimensional coordinate system within a patient's heart. The system allows the positions of one or more additional catheters 12, 14, 16, to be represented graphically on a graphical user interface 124 relative to a coordinate system; extrapolate catheter position from the coordinates of the transducer locations based on models of the various catheters pre-programmed into the system… their distal tips, their electrodes or ablation sections, if any, or other sections which may be of interest; The translation of a coordinates from the model to the coordinate system established by the ultrasound system is considered to read on the claimed limitation of calibrate between a first coordinate system of the 2D array and a second coordinate system of the position sensor as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Altmann in view of Moll, Harlev, and Barbagli to calibrate between a first coordinate system of the 2D array and a second coordinate system because it would have allowed identification of the locations of anatomical landmarks (such as the septal wall) relative to the coordinate system based on both the ultrasound measurements and from other references (Moll, Paragraph [0183]) and ensured contours are transformed in the 3-D coordinate space to align with the points in the electro-anatomical map (Altmann, Paragraph [0089]).
Response to Arguments
Claim Rejections under – 35 U.S.C. § 112(b)
Examiner acknowledges the amendments to claims 4, 6, and 16 and withdraws all previous rejections under 35 USC 112(b).
Claim Rejections under – 35 U.S.C. § 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
08/23/26
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