DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 10/29/2025 has been entered. Claims 1-2, 4 - 11, and 13-19 remain pending in the application.
Claim Objections
Claims 18 and 19 are objected to because of the following informalities:
In claim 18, line 3, “the length direction” should read “a length direction”.
In claim 19, line 13, “the probe” should read “a probe”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4, 10-11, 13, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over De Craene et al (US 20240260934), hereinafter De Craene, in view of Attia et al (US 20200015785), hereinafter Attia.
Regarding claim 1, De Craene teaches an ultrasound imaging system (10) (Abstract; “an ultrasound imaging method” [0049]; Fig. 1), comprising:
a probe (12) (“echocardiography” [0026]; “"The 3D Ultrasound imaging probe 12 provides continuous capture of ultrasound volumes and hence operates in a live mode." [0079]);
a display apparatus (18);
a processor (16) configured to:
control the probe to obtain an ultrasonic echo signal from a tissue to be imaged (“the echocardiographic exam” [0026]);
process the ultrasonic echo signal, in real time, to generate a volumetric ultrasound image of the tissue to be imaged (“[0050] acquiring real-time 3D images of a field of view volume with a 3D ultrasound imaging probe manually positioned by a user”; "The 3D Ultrasound imaging probe 12 provides continuous capture of ultrasound volumes and hence operates in a live mode." [0079] “The image data is provided to a controller 16 which performs real-time image analysis of the 3D images." [0080]);
identify, in the volumetric ultrasound image, a tissue to be subjected to intervention (“anatomical structure” [0052]; “a region of interest of the target anatomical structure” [0053]) (“[0049] The invention also provides an ultrasound imaging method, comprising: [0050] acquiring real-time 3D images of a field of view volume with a 3D ultrasound imaging probe manually positioned by a user; [0051] performing a real-time image analysis of the 3D images to: [0052] identify anatomical structure and landmarks in the 3D images; [0053] based on the identified anatomical structure and landmarks, determine if a region of interest of the target anatomical structure is present”); and
generate a movement guide for the probe on the basis of image information of the identified tissue to be subjected to intervention (“[0018] determine a relative position between the reference anatomical plane and a position and orientation of the 3D ultrasound imaging probe; and [0019] provide ultrasound guidance information based on the determined relative position.”; “[0025] Thus, the invention in this example provides an approach by which anatomical intelligence can capture 3D positions of anatomical structure (e.g. based on landmarks) and anatomical planes, as well providing indications about how to optimally place a probe to the user.”; “[0061] providing warnings or guidance to indicate required correction of the probe position to enable acquisition of a desired reference anatomical plane.”), and displaying the same (“the guidance is manual guidance advice to assist in capturing one of the reference anatomical planes i.e. reference views. The guidance then advises of the required corrections to be made in terms of probe motion (translation and/or rotation) to achieve the nearest reference view. The recommendations can be … implemented as voice over commands or graphical output.” [0089]) having a rotational guide and a translational guide (“translation and/or rotation” [0089]) that substantially center the tissue to be subject to intervention within the volumetric image (“centered on anatomical landmarks” [0028]; “the guidance may include translation instructions and tilting instructions." [0035]; “the guidance is manual guidance advice to assist in capturing one of the reference anatomical planes i.e. reference views. The guidance then advises of the required corrections to be made in terms of probe motion (translation and/or rotation) to achieve the nearest reference view.” [0089]. “The probe is then moved to the position shown in the right image in FIG. 2 with the axes 20,22 aligned. When the ultrasound and LV long axes align well, a confirmation is for example displayed (either graphically or with a message).” [0097]) and determine a length direction of the tissue (“along the long axis of the heart” [0036]) to be subject to intervention (“The aim is to assist imaging through a reference point (such as the apex of the heart) and a with a particular orientation (such as along the long axis of the heart and pointing to the mitral valve).” [0036]);
based on movement of the probe, updating, in real time, the movement guide (“[0025] providing indications about how to optimally place a probe to the user.”; “[0061] providing warnings or guidance to indicate required correction of the probe position to enable acquisition of a desired reference anatomical plane.”) to substantially center the tissue to be subject to intervention within the volumetric image (“centered on anatomical landmarks” [0028]); and
control the display apparatus to display the movement guide (“the guidance is manual guidance advice to assist in capturing one of the reference anatomical planes i.e. reference views. The guidance then advises of the required corrections to be made in terms of probe motion (translation and/or rotation) to achieve the nearest reference view. The recommendations can be … implemented as … graphical output.” [0089]).
De Craene does not explicitly teach the length direction being a direction of the greatest length of the tissue to be subject to intervention and aligning the length direction substantially parallel to a lateral plane of the volumetric image.
However, in the ultrasound imaging field of endeavor, Attia discloses volume rendered ultrasound imaging, which is analogous art. Attia teaches the length direction being a direction of the greatest length of the tissue to be subject to intervention (“determine the length of the 3-D path, … providing an accurate measurement of the dimension, e.g. length, of this anatomical feature” [0015]) and aligning the length direction substantially parallel to a lateral plane of the volumetric image (“the processing operation based on the defined 3-D path comprises at least one of a measurement of a length of the 3-D path; a reorientation of the rendered volumetric ultrasound image." [0014]; “the 3-D path may be used to reorient the rendered volumetric ultrasound image such that the 3-D path is aligned with the viewing angle or perpendicular to the viewing angle along the rendered volumetric ultrasound image, thereby providing the user with an option to reorient the volumetric ultrasound image inner intuitive manner, e.g. to obtain a view of an anatomical feature of interest identified of the user-specified points on which the 3-D path is based.” [0015]. A lateral plane is perpendicular to the viewing angle).
Therefore, based on Attia’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of De Craene to have the length direction being a direction of the greatest length of the tissue to be subject to intervention and align the length direction substantially parallel to a lateral plane of the volumetric image, as taught by Attia, in order to improve ultrasonic imaging of subject’s tissue.
Regarding claim 2, De Craene modified by Attia teaches the system according to claim 1, wherein De Craene teaches that the image information of the tissue to be subjected to intervention comprises:
size information of the tissue to be subjected to intervention, and/or orientation information of the tissue to be subjected to intervention in the volumetric ultrasound image (“[0021] The invention makes use of 3D anatomical intelligence to detect the anatomy of a target of interest (e.g. an organ, part of an organ, a valve) and the relative position/orientation between a reference anatomical plane (which is a desired plane to be imaged) of the target of interest (organ) and the ultrasound probe.”; “[0056] determine a relative position between the reference anatomical plane and a position and orientation of the 3D ultrasound imaging probe”).
Regarding claim 4, De Craene modified by Attia teaches the system according to claim 1, wherein De Craene teaches that the movement guide comprises at least one of a rotational guide for the probe, a translational guide for the probe along a surface of the tissue to be imaged (“translation and/or rotation” [0089]), and an indication of whether the probe has reached a predetermined movement position (“a confirmation” [0097]) (“the guidance may include translation instructions and tilting instructions." [0035]; “the guidance is manual guidance advice to assist in capturing one of the reference anatomical planes i.e. reference views. The guidance then advises of the required corrections to be made in terms of probe motion (translation and/or rotation) to achieve the nearest reference view.” [0089]. “The probe is then moved to the position shown in the right image in FIG. 2 with the axes 20,22 aligned. When the ultrasound and LV long axes align well, a confirmation is for example displayed (either graphically or with a message).” [0097]).
Regarding claim 10, De Craene teaches an ultrasound imaging method to support guiding an interventional object (Abstract; “an ultrasound imaging method” [0049]; “a region of interest of the target anatomical structure” [0053]. Because the method generates volumetric images including a region of interest, it can be used to support guiding an interventional object), comprising:
receiving, by using a probe (12), an ultrasonic echo signal from a tissue to be imaged (“echocardiography” [0026]);
processing the ultrasonic echo signal to generate a volumetric ultrasound image of the tissue to be imaged (“[0050] acquiring real-time 3D images of a field of view volume with a 3D ultrasound imaging probe manually positioned by a user”);
identifying a tissue to be subjected to intervention (“anatomical structure” [0052]; “a region of interest of the target anatomical structure” [0053]) (“[0049] The invention also provides an ultrasound imaging method, comprising: [0050] acquiring real-time 3D images of a field of view volume with a 3D ultrasound imaging probe manually positioned by a user; [0051] performing a real-time image analysis of the 3D images to: [0052] identify anatomical structure and landmarks in the 3D images; [0053] based on the identified anatomical structure and landmarks, determine if a region of interest of the target anatomical structure is present”);
generating and displaying a movement guide for the probe on the basis of image information of the identified tissue to be subjected to intervention (“[0018] determine a relative position between the reference anatomical plane and a position and orientation of the 3D ultrasound imaging probe; and [0019] provide ultrasound guidance information based on the determined relative position.”; “[0025] Thus, the invention in this example provides an approach by which anatomical intelligence can capture 3D positions of anatomical structure (e.g. based on landmarks) and anatomical planes, as well providing indications about how to optimally place a probe to the user.”; “[0061] providing warnings or guidance to indicate required correction of the probe position to enable acquisition of a desired reference anatomical plane.”; “the guidance is manual guidance advice to assist in capturing one of the reference anatomical planes i.e. reference views. The guidance then advises of the required corrections to be made in terms of probe motion (translation and/or rotation) to achieve the nearest reference view. The recommendations can be … implemented as voice over commands or graphical output.” [0089]) having a rotational guide and a translational guide (“translation and/or rotation” [0089]) that substantially center the tissue to be subject to intervention within the volumetric image (“centered on anatomical landmarks” [0028]; “the guidance may include translation instructions and tilting instructions." [0035]; “the guidance is manual guidance advice to assist in capturing one of the reference anatomical planes i.e. reference views. The guidance then advises of the required corrections to be made in terms of probe motion (translation and/or rotation) to achieve the nearest reference view.” [0089]. “The probe is then moved to the position shown in the right image in FIG. 2 with the axes 20,22 aligned. When the ultrasound and LV long axes align well, a confirmation is for example displayed (either graphically or with a message).” [0097]) and determining a length direction of the tissue (“along the long axis of the heart” [0036]) to be subject to intervention (“The aim is to assist imaging through a reference point (such as the apex of the heart) and a with a particular orientation (such as along the long axis of the heart and pointing to the mitral valve).” [0036]);
generating and displaying a movement guide for the probe (“[0018] determine a relative position between the reference anatomical plane and a position and orientation of the 3D ultrasound imaging probe; and [0019] provide ultrasound guidance information based on the determined relative position.”; “[0025] Thus, the invention in this example provides an approach by which anatomical intelligence can capture 3D positions of anatomical structure (e.g. based on landmarks) and anatomical planes, as well providing indications about how to optimally place a probe to the user.”; “[0061] providing warnings or guidance to indicate required correction of the probe position to enable acquisition of a desired reference anatomical plane.”) (“the guidance is manual guidance advice to assist in capturing one of the reference anatomical planes i.e. reference views. The guidance then advises of the required corrections to be made in terms of probe motion (translation and/or rotation) to achieve the nearest reference view. The recommendations can be … implemented as voice over commands or graphical output.” [0089]) having a rotational guide and a translational guide (“translation and/or rotation” [0089]) that substantially center the tissue to be subject to intervention within the volumetric image (“centered on anatomical landmarks” [0028]; “the guidance may include translation instructions and tilting instructions." [0035]; “the guidance is manual guidance advice to assist in capturing one of the reference anatomical planes i.e. reference views. The guidance then advises of the required corrections to be made in terms of probe motion (translation and/or rotation) to achieve the nearest reference view.” [0089]. “The probe is then moved to the position shown in the right image in FIG. 2 with the axes 20,22 aligned. When the ultrasound and LV long axes align well, a confirmation is for example displayed (either graphically or with a message).” [0097]) and determine a length direction of the tissue (“along the long axis of the heart” [0036]) to be subject to intervention (“The aim is to assist imaging through a reference point (such as the apex of the heart) and a with a particular orientation (such as along the long axis of the heart and pointing to the mitral valve).” [0036]); and
based on movement of the probe, updating, in real time, the movement guide (“[0025] providing indications about how to optimally place a probe to the user.”; “[0061] providing warnings or guidance to indicate required correction of the probe position to enable acquisition of a desired reference anatomical plane.”) to substantially center the tissue to be subject to intervention within the volumetric image (“centered on anatomical landmarks” [0028]).
De Craene does not explicitly teach the length direction being a direction of the greatest length of the tissue to be subject to intervention and aligning the length direction substantially parallel to a lateral plane of the volumetric image.
However, in the ultrasound imaging field of endeavor, Attia discloses volume rendered ultrasound imaging, which is analogous art. Attia teaches the length direction being a direction of the greatest length of the tissue to be subject to intervention (“determine the length of the 3-D path, … providing an accurate measurement of the dimension, e.g. length, of this anatomical feature” [0015]) and aligning the length direction substantially parallel to a lateral plane of the volumetric image (“the processing operation based on the defined 3-D path comprises at least one of a measurement of a length of the 3-D path; a reorientation of the rendered volumetric ultrasound image." [0014]; “the 3-D path may be used to reorient the rendered volumetric ultrasound image such that the 3-D path is aligned with the viewing angle or perpendicular to the viewing angle along the rendered volumetric ultrasound image, thereby providing the user with an option to reorient the volumetric ultrasound image inner intuitive manner, e.g. to obtain a view of an anatomical feature of interest identified of the user-specified points on which the 3-D path is based.” [0015]. A lateral plane is perpendicular to the viewing angle).
Therefore, based on Attia’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of De Craene to have the length direction being a direction of the greatest length of the tissue to be subject to intervention and align the length direction substantially parallel to a lateral plane of the volumetric image, as taught by Attia, in order to improve ultrasonic imaging of subject’s tissue.
Regarding claim 11, De Craene modified by Attia teaches the method according to claim 10, wherein De Craene teaches that the image information of the tissue to be subjected to intervention comprises:
size information of the tissue to be subjected to intervention, and/or orientation information of the tissue to be subjected to intervention in the volumetric ultrasound image (“[0021] The invention makes use of 3D anatomical intelligence to detect the anatomy of a target of interest (e.g. an organ, part of an organ, a valve) and the relative position/orientation between a reference anatomical plane (which is a desired plane to be imaged) of the target of interest (organ) and the ultrasound probe.”; “[0056] determine a relative position between the reference anatomical plane and a position and orientation of the 3D ultrasound imaging probe”).
Regarding claim 13, De Craene modified by Attia teaches the method according to claim 10, wherein De Craene teaches that the movement guide comprises an indication of whether the probe has reached a predetermined movement position (“a confirmation” [0097]) (“the guidance may include translation instructions and tilting instructions." [0035]; “the guidance is manual guidance advice to assist in capturing one of the reference anatomical planes i.e. reference views. The guidance then advises of the required corrections to be made in terms of probe motion (translation and/or rotation) to achieve the nearest reference view.” [0089]. “The probe is then moved to the position shown in the right image in FIG. 2 with the axes 20,22 aligned. When the ultrasound and LV long axes align well, a confirmation is for example displayed (either graphically or with a message).” [0097]).
Regarding claim 19, De Craene modified by Attia teaches a non-transitory computer-readable medium, the non-transitory computer-readable medium having a computer program stored thereon, the computer program having at least one code segment, and the at least one code segment being executable by a machine (“The invention also provides a computer program comprising computer program code means which is adapted, when said program is run on a computer, to implement the method defined above." [0067]) to enable the machine to execute the steps of:
obtaining an ultrasonic echo signal from a tissue to be imaged (“echocardiography” [0026]);
processing the ultrasonic echo signal to generate a volumetric ultrasound image of the tissue to be imaged (“[0050] acquiring real-time 3D images of a field of view volume with a 3D ultrasound imaging probe manually positioned by a user”);
identifying a tissue to be subjected to intervention (“anatomical structure” [0052]; “a region of interest of the target anatomical structure” [0053]) in the volumetric ultrasound image (“[0049] The invention also provides an ultrasound imaging method, comprising: [0050] acquiring real-time 3D images of a field of view volume with a 3D ultrasound imaging probe manually positioned by a user; [0051] performing a real-time image analysis of the 3D images to: [0052] identify anatomical structure and landmarks in the 3D images; [0053] based on the identified anatomical structure and landmarks, determine if a region of interest of the target anatomical structure is present”); and
generating and displaying a movement guide for the probe (“[0018] determine a relative position between the reference anatomical plane and a position and orientation of the 3D ultrasound imaging probe; and [0019] provide ultrasound guidance information based on the determined relative position.”; “[0025] Thus, the invention in this example provides an approach by which anatomical intelligence can capture 3D positions of anatomical structure (e.g. based on landmarks) and anatomical planes, as well providing indications about how to optimally place a probe to the user.”; “[0061] providing warnings or guidance to indicate required correction of the probe position to enable acquisition of a desired reference anatomical plane.”) (“the guidance is manual guidance advice to assist in capturing one of the reference anatomical planes i.e. reference views. The guidance then advises of the required corrections to be made in terms of probe motion (translation and/or rotation) to achieve the nearest reference view. The recommendations can be … implemented as voice over commands or graphical output.” [0089]) having a rotational guide and a translational guide (“translation and/or rotation” [0089]) that substantially center the tissue to be subject to intervention within the volumetric image (“centered on anatomical landmarks” [0028]; “the guidance may include translation instructions and tilting instructions." [0035]; “the guidance is manual guidance advice to assist in capturing one of the reference anatomical planes i.e. reference views. The guidance then advises of the required corrections to be made in terms of probe motion (translation and/or rotation) to achieve the nearest reference view.” [0089]. “The probe is then moved to the position shown in the right image in FIG. 2 with the axes 20,22 aligned. When the ultrasound and LV long axes align well, a confirmation is for example displayed (either graphically or with a message).” [0097]) and determine a length direction of the tissue (“along the long axis of the heart” [0036]) to be subject to intervention (“The aim is to assist imaging through a reference point (such as the apex of the heart) and a with a particular orientation (such as along the long axis of the heart and pointing to the mitral valve).” [0036]); and
based on movement of the probe, updating, in real time, the movement guide (“[0025] providing indications about how to optimally place a probe to the user.”; “[0061] providing warnings or guidance to indicate required correction of the probe position to enable acquisition of a desired reference anatomical plane.”) to substantially center the tissue to be subject to intervention within the volumetric image (“centered on anatomical landmarks” [0028]).
De Craene does not explicitly teach the length direction being a direction of the greatest length of the tissue to be subject to intervention and aligning the length direction substantially parallel to a lateral plane of the volumetric image.
However, in the ultrasound imaging field of endeavor, Attia discloses volume rendered ultrasound imaging, which is analogous art. Attia teaches the length direction being a direction of the greatest length of the tissue to be subject to intervention (“determine the length of the 3-D path, … providing an accurate measurement of the dimension, e.g. length, of this anatomical feature” [0015]) and aligning the length direction substantially parallel to a lateral plane of the volumetric image (“the processing operation based on the defined 3-D path comprises at least one of a measurement of a length of the 3-D path; a reorientation of the rendered volumetric ultrasound image." [0014]; “the 3-D path may be used to reorient the rendered volumetric ultrasound image such that the 3-D path is aligned with the viewing angle or perpendicular to the viewing angle along the rendered volumetric ultrasound image, thereby providing the user with an option to reorient the volumetric ultrasound image inner intuitive manner, e.g. to obtain a view of an anatomical feature of interest identified of the user-specified points on which the 3-D path is based.” [0015]. A lateral plane is perpendicular to the viewing angle).
Therefore, based on Attia’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of De Craene to have the length direction being a direction of the greatest length of the tissue to be subject to intervention and align the length direction substantially parallel to a lateral plane of the volumetric image, as taught by Attia, in order to improve ultrasonic imaging of subject’s tissue.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over De Craene and Attia as applied to claim 1, and further in view of Yeh et al (US 20100113929), hereinafter, Yeh.
Regarding claim 5, De Craene modified by Attia teaches the system according to claim 1, wherein De Craene teaches that the processor is further configured to:
perform real-time volumetric imaging on the tissue to be imaged (“[0050] acquiring real-time 3D images of a field of view volume with a 3D ultrasound imaging probe manually positioned by a user”); and
generate and display, in real time, the movement guide for the probe during movement of the probe (“The controller connects to a display 18 which functions as a user interface and provides ultrasound guidance information, for example to assist the user in repositioning the ultrasound probe to enable the desired image to be taken.” [0081]. “The recommendation system may then calculate and indicate the ultrasonic probe motion necessary to correct the current probe position and achieve the nearest reference view. The required corrective probe motion is schematically displayed to guide the sonographer, for example as displayed probe movement instructions.” [0096] The ultrasound guidance information has to be displayed in real time to assist in repositioning the ultrasound probe).
De Craene modified by Attia does not explicitly teach performing, during movement of the probe, real-time volumetric imaging on the tissue to be imaged.
However, in the ultrasound diagnostic systems field of endeavor, Yeh discloses high-frequency ultrasonic imaging system and method, which is analogous art. Yeh teaches performing, during movement of the probe, real-time imaging on the tissue to be imaged (“Referring to FIG. 3, the first object 102 is located in the second object 104. The ultrasonic transducer 110 can be moved along the scanning route 112 parallel to the contour of the first object 102 during scanning, because the ultrasonic transducer 110 can be simultaneously moved horizontally in the Y axis and vertically in Z axis by the driving device 120. These scanning and imaging steps are named as a "skin scanning method". According to the skin scanning method for the high-frequency ultrasonic imaging system 100 of the present invention, the ultrasonic transducer 110 transmits ultrasonic pulses and receives echoes during the movement of the ultrasonic transducer 110 so as to perform the ultrasonic image in real time.” [0025]).
Therefore, based on Yeh’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of De Craene and Attia to have the step of performing, during movement of the probe, real-time imaging on the tissue to be imaged, as taught by Yeh, in order to facilitate probe movement along the scanning route. In invention of De Craene and Yeh, real-time imaging is volumetric imaging.
Claims 6 – 8 are rejected under 35 U.S.C. 103 as being unpatentable over De Craene and Attia as applied to claim 1, and further in view of Vertikov (US 20190142528), hereinafter, Vertikov.
Regarding claim 6, De Craene modified by Attia teaches the system according to claim 1, wherein De Craene teaches that the processor is further configured to:
perform two-dimensional ultrasound imaging by using the probe, to generate a two-dimensional ultrasound image (“The user interface may include output buttons for the selection of standard 2D planar acquisitions (possibly batched) such as the 2-, 3- and 4-Chambers views. These buttons allow to automatically switch to one or several planes of reference.” [0098]).
De Craene modified by Attia does not explicitly teach identifying an interventional object and the tissue to be subjected to intervention in the two-dimensional ultrasound image.
However, in the ultrasound diagnostic systems field of endeavor, Vertikov discloses a method and system for image-guided procedures, which is analogous art. Vertikov teaches identifying an interventional object and the tissue to be subjected to intervention in the two-dimensional ultrasound image (“acquiring image data of at least a portion of tissue in proximity to the target and/or the medical tool. The method also includes determining position and orientation of the medical tool relative to the target by processing the image data acquired by the imaging probe using any of the following: processing Doppler shifts in .., 2D, and … sub-sets of the image data; processing speckles in the …, 2D, and … sub-sets of the image data; comparing the …, 2D, and … sub-sets of the image data with reference image data pre-acquired and stored in data processing memory of the imaging console; comparing tissue identifiers pre-computed from the reference image data pre-acquired and stored in data processing memory of the imaging console with tissue parameters determined from the image data;” [0016]).
Therefore, based on Vertikov’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of De Craene and Attia to have the step of identifying an interventional object and the tissue to be subjected to intervention in the two-dimensional ultrasound image, as taught by Vertikov, in order to facilitate positioning of an interventional object.
Regarding claim 7, De Craene modified by Attia and Vertikov teaches the system according to claim 6, wherein De Craene modified by Attia teaches that the processor is further configured to:
identify at least one anatomical feature in the two-dimensional ultrasound image (“The user interface may include output buttons for the selection of standard 2D planar acquisitions (possibly batched) such as the 2-, 3- and 4-Chambers views. These buttons allow to automatically switch to one or several planes of reference.” [0098]).
De Craene modified by Attia does not explicitly teach the interventional object comprising an anesthetic needle; determining a target intervention position of the anesthetic needle based on relative positions of the at least one anatomical feature and the tissue to be subjected to intervention; and
providing an intervention guide for the anesthetic needle based on a current position of the anesthetic needle and the target intervention position.
However, in the ultrasound diagnostic systems field of endeavor, Vertikov discloses a method and system for image-guided procedures, which is analogous art. Vertikov teaches the interventional object comprising an anesthetic needle (“an injection needle that delivers therapeutic agents,” [0003]);
determining a target intervention position of the anesthetic needle based on relative positions of the at least one anatomical feature and the tissue to be subjected to intervention (“image guidance is aimed at identifying and localizing a specific target within a patient body to allow for accurately placing a medical instrument or tool in this target to perform a medical procedure with the tool while avoiding anatomical risk structures. Many medical tools exist with specific intended uses for specific medical procedures such as, for example: an injection needle that delivers therapeutic agents; a biopsy instrument that takes tissue samples, such as an aspiration needle,” [0003]); and
providing an intervention guide for the anesthetic needle based on a current position of the anesthetic needle and the target intervention position (“a method of guiding a medical tool to a target in a tissue using a system having an imaging probe and an imaging console is provided. The method includes advancing a distal end of the medical tool towards the target, …and acquiring image data of at least a portion of tissue in proximity to the target and/or the medical tool. The method also includes determining position and orientation of the medical tool relative to the target by processing the image data acquired by the imaging probe using any of the following: processing Doppler shifts in .., 2D, and … sub-sets of the image data; processing speckles in the …, 2D, and … sub-sets of the image data; comparing the …, 2D, and … sub-sets of the image data with reference image data pre-acquired and stored in data processing memory of the imaging console; comparing tissue identifiers pre-computed from the reference image data pre-acquired and stored in data processing memory of the imaging console with tissue parameters determined from the image data;” [0016]).
Therefore, based on Vertikov’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of De Craene and Attia to employ the interventional object comprising an anesthetic needle; and the steps of determining a target intervention position of the anesthetic needle based on relative positions of the at least one anatomical feature and the tissue to be subjected to intervention; and providing an intervention guide for the anesthetic needle based on a current position of the anesthetic needle and the target intervention position, as taught by Vertikov, in order to facilitate positioning of the anesthetic needle in a target tissue.
Regarding claim 8, De Craene modified by Attia and Vertikov teaches the system according to claim 6.
De Craene modified by Attia does not explicitly teach that the interventional object comprises a sampling needle, and determining, based on the relative positions of the sampling needle and the tissue to be subjected to intervention, whether the sampling needle has reached a target intervention position, to provide an intervention guide for the sampling needle.
However, in the ultrasound diagnostic systems field of endeavor, Vertikov discloses a method and system for image-guided procedures, which is analogous art. Vertikov teaches the interventional object comprising a sampling needle (“a biopsy instrument that takes tissue samples, such as an aspiration needle,” [0003]); and
determining, based on the relative positions of the sampling needle and the tissue to be subjected to intervention, whether the sampling needle has reached a target intervention position, to provide an intervention guide for the sampling needle (“image guidance is aimed at identifying and localizing a specific target within a patient body to allow for accurately placing a medical instrument or tool in this target to perform a medical procedure with the tool while avoiding anatomical risk structures. Many medical tools exist with specific intended uses for specific medical procedures such as, for example: …a biopsy instrument that takes tissue samples, such as an aspiration needle,” [0003]; “a method of guiding a medical tool to a target in a tissue using a system having an imaging probe and an imaging console is provided. The method includes advancing a distal end of the medical tool towards the target, …and acquiring image data of at least a portion of tissue in proximity to the target and/or the medical tool. The method also includes determining position and orientation of the medical tool relative to the target by processing the image data acquired by the imaging probe using any of the following: processing Doppler shifts in .., 2D, and … sub-sets of the image data; processing speckles in the …, 2D, and … sub-sets of the image data; comparing the …, 2D, and … sub-sets of the image data with reference image data pre-acquired and stored in data processing memory of the imaging console; comparing tissue identifiers pre-computed from the reference image data pre-acquired and stored in data processing memory of the imaging console with tissue parameters determined from the image data;” [0016]).
Therefore, based on Vertikov’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of De Craene and Attia to employ the interventional object that comprises a sampling needle, and the processor further configured to determine, based on the relative positions of the sampling needle and the tissue to be subjected to intervention, whether the sampling needle has reached a target intervention position, to provide an intervention guide for the sampling needle, as taught by Vertikov, in order to facilitate positioning of the sampling needle in a target tissue.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over De Craene, Attia, and Vertikov as applied to claim 6, and further in view of Rothgang (US 20130245427), hereinafter, Rothgang.
Regarding claim 9, De Craene modified by Attia and Vertikov teaches the system according to claim 6, wherein De Craene modified by Attia teaches the two-dimensional ultrasound image comprises a first image and a second image (“The user interface may include output buttons for the selection of standard 2D planar acquisitions (possibly batched) such as the 2-, 3- and 4-Chambers views. These buttons allow to automatically switch to one or several planes of reference.” [0098]).
De Craene modified by Attia does not explicitly teach that the interventional object comprises a sampling needle.
However, in the ultrasound diagnostic systems field of endeavor, Vertikov discloses a method and system for image-guided procedures, which is analogous art. Vertikov teaches the interventional object comprising a sampling needle (“a biopsy instrument that takes tissue samples, such as an aspiration needle,” [0003]).
Therefore, based on Vertikov’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of De Craene and Attia to employ the interventional object that comprises a sampling needle, as taught by Vertikov, in order to facilitate providing biopsy.
De Craene modified by Attia and Vertikov does not teach that a length direction of the sampling needle passing through the plane in which the first image is located and being perpendicular to the plane in which the second image is located.
However, in the medical systems field of endeavor, Rothgang discloses a method and magnetic resonance system to automatically determine imaging planes, which is analogous art. Rothgang teaches that a length direction of the sampling needle (“a needle” [0021]) passing through the plane in which the first image is located (41) (“the first and second imaging plane” [0021]. “The first MR plane 41 is therefore determined such that it includes the trajectory {right arrow over (d)}.sub.p, [0088]; Figs. 2-3) and being perpendicular to the plane in which the second image is located (“the third imaging plane” [0021]).
Therefore, based on Rothgang’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of De Craene, Attia, and Vertikov to have a length direction of the sampling needle passing through the plane in which the first image is located and being perpendicular to the plane in which the second image is located, as taught by Rothgang, in order to facilitate position adjustments of the sampling needle.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over De Craene and Attia as applied to claim 10, and further in view of Yeh et al (US 20100113929), hereinafter, Yeh.
Regarding claim 14, De Craene modified by Attia teaches the method according to claim 10, De Craene teaches further comprising:
performing real-time volumetric imaging on the tissue to be imaged (“[0050] acquiring real-time 3D images of a field of view volume with a 3D ultrasound imaging probe manually positioned by a user”); and
generating and displaying, in real time, the movement guide for the probe during movement of the probe (“The controller connects to a display 18 which functions as a user interface and provides ultrasound guidance information, for example to assist the user in repositioning the ultrasound probe to enable the desired image to be taken.” [0081]. “The recommendation system may then calculate and indicate the ultrasonic probe motion necessary to correct the current probe position and achieve the nearest reference view. The required corrective probe motion is schematically displayed to guide the sonographer, for example as displayed probe movement instructions.” [0096] The ultrasound guidance information has to be displayed in real time to assist in repositioning the ultrasound probe).
De Craene modified by Attia does not explicitly teach performing, during movement of the probe, real-time volumetric imaging on the tissue to be imaged.
However, in the ultrasound diagnostic systems field of endeavor, Yeh discloses high-frequency ultrasonic imaging system and method, which is analogous art. Yeh teaches performing, during movement of the probe, real-time imaging on the tissue to be imaged (“Referring to FIG. 3, the first object 102 is located in the second object 104. The ultrasonic transducer 110 can be moved along the scanning route 112 parallel to the contour of the first object 102 during scanning, because the ultrasonic transducer 110 can be simultaneously moved horizontally in the Y axis and vertically in Z axis by the driving device 120. These scanning and imaging steps are named as a "skin scanning method". According to the skin scanning method for the high-frequency ultrasonic imaging system 100 of the present invention, the ultrasonic transducer 110 transmits ultrasonic pulses and receives echoes during the movement of the ultrasonic transducer 110 so as to perform the ultrasonic image in real time.” [0025]).
Therefore, based on Yeh’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of De Craene and Attia to have the step of performing, during movement of the probe, real-time imaging on the tissue to be imaged, as taught by Yeh, in order to facilitate probe movement along the scanning route. In invention of De Craene, Attia, and Yeh, real-time imaging is volumetric imaging.
Claims 15 – 17 are rejected under 35 U.S.C. 103 as being unpatentable over De Craen and Attia as applied to claim 10, and further in view of Vertikov (US 20190142528), hereinafter, Vertikov.
Regarding claim 15, De Craene modified by Attia teaches the method according to claim 10, further comprising:
performing two-dimensional ultrasound imaging by using the probe, to generate a two-dimensional ultrasound image (“The user interface may include output buttons for the selection of standard 2D planar acquisitions (possibly batched) such as the 2-, 3- and 4-Chambers views. These buttons allow to automatically switch to one or several planes of reference.” [0098]).
De Craene does not explicitly teach identifying an interventional object and the tissue to be subjected to intervention in the two-dimensional ultrasound image.
However, in the ultrasound diagnostic systems field of endeavor, Vertikov discloses a method and system for image-guided procedures, which is analogous art. Vertikov teaches identifying an interventional object and the tissue to be subjected to intervention in the two-dimensional ultrasound image (“acquiring image data of at least a portion of tissue in proximity to the target and/or the medical tool. The method also includes determining position and orientation of the medical tool relative to the target by processing the image data acquired by the imaging probe using any of the following: processing Doppler shifts in .., 2D, and … sub-sets of the image data; processing speckles in the …, 2D, and … sub-sets of the image data; comparing the …, 2D, and … sub-sets of the image data with reference image data pre-acquired and stored in data processing memory of the imaging console; comparing tissue identifiers pre-computed from the reference image data pre-acquired and stored in data processing memory of the imaging console with tissue parameters determined from the image data;” [0016]).
Therefore, based on Vertikov’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of De Craene and Attia to have the step of identifying an interventional object and the tissue to be subjected to intervention in the two-dimensional ultrasound image, as taught by Vertikov, in order to facilitate positioning of an interventional object.
Regarding claim 16, De Craene modified by Attia and Vertikov teaches the method according to claim 15, wherein De Craene teaches that the method further comprises:
identifying at least one anatomical feature in the two-dimensional ultrasound image (“The user interface may include output buttons for the selection of standard 2D planar acquisitions (possibly batched) such as the 2-, 3- and 4-Chambers views. These buttons allow to automatically switch to one or several planes of reference.” [0098]).
De Craene modified by Attia does not explicitly teach the interventional object comprising an anesthetic needle; determining a target intervention position of the anesthetic needle based on the relative positions of the at least one anatomical feature and the tissue to be subjected to intervention; and
providing an intervention guide for the anesthetic needle based on a current position of the anesthetic needle and the target intervention position.
However, in the ultrasound diagnostic systems field of endeavor, Vertikov discloses a method and system for image-guided procedures, which is analogous art. Vertikov teaches the interventional object comprising an anesthetic needle (“an injection needle that delivers therapeutic agents,” [0003]);
determining a target intervention position of the anesthetic needle based on the relative positions of the at least one anatomical feature and the tissue to be subjected to intervention (“image guidance is aimed at identifying and localizing a specific target within a patient body to allow for accurately placing a medical instrument or tool in this target to perform a medical procedure with the tool while avoiding anatomical risk structures. Many medical tools exist with specific intended uses for specific medical procedures such as, for example: an injection needle that delivers therapeutic agents; a biopsy instrument that takes tissue samples, such as an aspiration needle,” [0003]); and
providing an intervention guide for the anesthetic needle based on a current position of the anesthetic needle and the target intervention position (“a method of guiding a medical tool to a target in a tissue using a system having an imaging probe and an imaging console is provided. The method includes advancing a distal end of the medical tool towards the target, …and acquiring image data of at least a portion of tissue in proximity to the target and/or the medical tool. The method also includes determining position and orientation of the medical tool relative to the target by processing the image data acquired by the imaging probe using any of the following: processing Doppler shifts in .., 2D, and … sub-sets of the image data; processing speckles in the …, 2D, and … sub-sets of the image data; comparing the …, 2D, and … sub-sets of the image data with reference image data pre-acquired and stored in data processing memory of the imaging console; comparing tissue identifiers pre-computed from the reference image data pre-acquired and stored in data processing memory of the imaging console with tissue parameters determined from the image data;” [0016]).
Therefore, based on Vertikov’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of De Craene and Attia to employ the interventional object comprising an anesthetic needle; and the steps of determining a target intervention position of the anesthetic needle based on the relative positions of the at least one anatomical feature and the tissue to be subjected to intervention; and providing an intervention guide for the anesthetic needle based on a current position of the anesthetic needle and the target intervention position, as taught by Vertikov, in order to facilitate positioning of the anesthetic needle in a target tissue.
Regarding claim 17, De Craene modified by Attia and Vertikov teaches the method according to claim 15.
De Craene modified by Attia does not explicitly teach that the interventional object comprises a sampling needle, and the method further comprises: determining, based on relative positions of the sampling needle and the tissue to be subjected to intervention, whether the sampling needle has reached a target intervention position, to provide an intervention guide for the sampling needle.
However, in the ultrasound diagnostic systems field of endeavor, Vertikov discloses a method and system for image-guided procedures, which is analogous art. Vertikov teaches the interventional object comprising an sampling needle (“a biopsy instrument that takes tissue samples, such as an aspiration needle,” [0003]);
determining, based on relative positions of the sampling needle and the tissue to be subjected to intervention, whether the sampling needle has reached a target intervention position, to provide an intervention guide for the sampling needle (“image guidance is aimed at identifying and localizing a specific target within a patient body to allow for accurately placing a medical instrument or tool in this target to perform a medical procedure with the tool while avoiding anatomical risk structures. Many medical tools exist with specific intended uses for specific medical procedures such as, for example: …a biopsy instrument that takes tissue samples, such as an aspiration needle,” [0003]; “a method of guiding a medical tool to a target in a tissue using a system having an imaging probe and an imaging console is provided. The method includes advancing a distal end of the medical tool towards the target, …and acquiring image data of at least a portion of tissue in proximity to the target and/or the medical tool. The method also includes determining position and orientation of the medical tool relative to the target by processing the image data acquired by the imaging probe using any of the following: processing Doppler shifts in .., 2D, and … sub-sets of the image data; processing speckles in the …, 2D, and … sub-sets of the image data; comparing the …, 2D, and … sub-sets of the image data with reference image data pre-acquired and stored in data processing memory of the imaging console; comparing tissue identifiers pre-computed from the reference image data pre-acquired and stored in data processing memory of the imaging console with tissue parameters determined from the image data;” [0016]).
Therefore, based on Vertikov’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of De Craene and Attia to employ the interventional object that comprises a sampling needle, and the method that further comprises: determining, based on relative positions of the sampling needle and the tissue to be subjected to intervention, whether the sampling needle has reached a target intervention position, to provide an intervention guide for the sampling needle, as taught by Vertikov, in order to facilitate positioning of the sampling needle in a target tissue.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over De Craene, Attia, and Vertikov as applied to claim 15, and further in view of Rothgang (US 20130245427), hereinafter, Rothgang.
Regarding claim 18, De Craene modified by Attia and Vertikov teaches the method according to claim 15, wherein De Craene teaches the two-dimensional ultrasound image comprises a first image and a second image (“The user interface may include output buttons for the selection of standard 2D planar acquisitions (possibly batched) such as the 2-, 3- and 4-Chambers views. These buttons allow to automatically switch to one or several planes of reference.” [0098]).
De Craene modified by Attia does not explicitly teach that the interventional object comprises a sampling needle.
However, in the ultrasound diagnostic systems field of endeavor, Vertikov discloses a method and system for image-guided procedures, which is analogous art. Vertikov teaches the interventional object comprising a sampling needle (“a biopsy instrument that takes tissue samples, such as an aspiration needle,” [0003]).
Therefore, based on Vertikov’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of De Craene and Attia to employ the interventional object that comprises a sampling needle, as taught by Vertikov, in order to facilitate providing biopsy.
De Craene modified by Attia and Vertikov does not teach that the length direction of the sampling needle passing through the plane in which the first image is located and being perpendicular to the plane in which the second image is located.
However, in the medical systems field of endeavor, Rothgang discloses a method and magnetic resonance system to automatically determine imaging planes, which is analogous art. Rothgang teaches that the length direction of the sampling needle (“a needle” [0021]) passing through the plane in which the first image is located (41) (“the first and second imaging plane” [0021]. “The first MR plane 41 is therefore determined such that it includes the trajectory {right arrow over (d)}.sub.p, [0088]; Figs. 2-3) and being perpendicular to the plane in which the second image is located (“the third imaging plane” [0021]).
Therefore, based on Rothgang’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of De Craene, Attia, and Vertikov to have the length direction of the sampling needle passing through the plane in which the first image is located and being perpendicular to the plane in which the second image is located, as taught by Rothgang, in order to facilitate position adjustments of the sampling needle.
Response to Arguments
Applicant's arguments filed 10/29/2025 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over De Craene in view of Attia.
Response to the 35 U.S.C. §101 rejection arguments on pages 9-11 of the REMARKS.
Claims 1-2, 4 - 11, and 13-19
The Applicant argues that “The claims do not merely "apply" an abstract idea or mathematical concept on a generic computer. Instead, they improve the functioning of an ultrasound imaging system by enabling real-time, lesion-centric probe guidance.” (Page 11). The Examiner agrees and therefore the rejection has been withdrawn.
Response to the 35 U.S.C. §102 and §103 rejection arguments on pages 11-14 of the REMARKS.
Claims 1-2, 4 - 11, and 13-19
The Applicant argues that “As discussed in the Examiner Interview Section, the Examiner agreed that the amended independent claims overcame the prior art rejection and therefore are patentable over the cited prior art references… Applicant respectfully requests reconsideration and withdrawal of the rejections.” (Page 12). The Examiner agrees and therefore the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over De Craene in view of Attia.The dependent claims are not allowable because the independent claims are not allowable and because additional secondary references meet additional limitations of the dependent claims.
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 extension fee 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 ALEXEI BYKHOVSKI whose telephone number is (571)270-1556. The examiner can normally be reached on Monday-Friday: 8:30am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798