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 .
DETAILED ACTION
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 8-15 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Kruecker et al (U.S. Pub. No: 2017/0304644 A1).
Regarding claim 1, Kruecker discloses a prostate puncture support device comprising: a processor, wherein the processor is configured to: acquire a reference volume image that is obtained before surgery and includes a prostate and a region of interest in the prostate, a surgical field image that is acquired by a camera positioned outside a body and includes at least a puncture needle image marker attached to a puncture needle, and an ultrasound image that is acquired by an ultrasound probe (see abstract, also page 6, paragraphs, [0056-0060] the process may acquire a “3D reference image” dataset of a volume-of-interest (VOI). The 3D reference image dataset may include a plurality of 2D image slices of the VOI in which a desired object-of-interest (OOI) such as a “prostate” of a patient may be located. Accordingly, the reference dataset may include N image slices of the desired OOI such as the prostate. These N image slices may be taken in one or more image planes. For example, in accordance with some embodiments, the image slices may be in the sagittal plane while in other embodiments the image slices may be in the transverse or other plane or planes. The reference dataset may be acquired using any suitable “ultrasound imaging” apparatus such as a TRUS probe or the like. However, in yet other embodiments other types of imaging devices are also envisioned and may be used with and/or substituted for the TRUS probe. During acquisition of the reference dataset, the imaging apparatus (e.g., the TRUS probe) may be tracked (e.g., by sensors of the system) so that a position and/or orientation of the TRUS probe may be determined and associated with each corresponding 2D image slice acquired. These image slices may then be stacked to form a 3D reference dataset. In accordance with some embodiments, it is envisioned that the “3D (volume), reference” dataset and/or portions thereof may be acquired using one or more imaging methods such as MRI, CT, MR, positron-emission tomography (PET), and/or ultrasound imaging methods. The acquired image information that may be obtained from multiple image acquisition sources may be registered to form all and/or a portion of the 3D the reference dataset, if desired. However, for the sake of clarity, it will be assumed that the 3D reference dataset is acquired using the TRUS probe described herein. For example, embodiments of the present system may translate functional information in real-time to provide a real-time guidance, if desired. The TRUS probe may be located in a desired position and/or orientation relative to the patient. For example, FIG. 2A shows a setup of the TRUS probe relative to the prostate of the patient so that it may acquire a reference dataset. The TRUS probe may be tracked during the acquisition of the reference dataset so that position and/or orientation of the TRUS probe during acquisition of each 2D slice may be associated with the corresponding 2D slice of the 3D reference image dataset as location information. More particularly, the process may track the position and/or orientation of the TRUS probe, form corresponding location information, and associate this location information with corresponding 2D image slices of the reference dataset such as that shown in FIG. 5 which shows a flow diagram 500 of a process performed in accordance with embodiments of the present system. FIG. 5 shows a three-dimensional (3D) reference dataset that may include a pre-acquired 3D image dataset having a plurality of two-dimensional (2D) image slices (e.g., 2D slices) taken of a VOI which may include the OOI, acquired prior to catheter insertion into the patient and stored in a memory for retrieval and referral during acquisition of further images using a catheter inserted into the patient.
Also page 12, paragraphs, [0114-0115], as discussed above, as “needles are inserted” into the prostate, the prostate may change its shape and the process may update deformation vectors to take this change of shape into account. The process may calculate “registration” constraints which take into account the deformation of the prostate and update the deformation vectors according to the registration constraints. Then, the process may update the selected CBS in accordance with these updated deformation vectors so as to form a current CBS which may act as a modification contour which, as discussed above, may estimate the deformed boundaries of the prostate. After completing act 421, the process may continue to act. During act 423, the process may determine whether there is a significant change in the estimated boundaries of the prostate due to insertion one or more of the catheters into the prostate. Accordingly, if it is determined that there is a significant change in the estimated boundaries of the prostate, the process may continue to act 425. However, if it is determined that there is no significant change in the estimated boundaries of the prostate, the process may continue to act 426. The process may determine that there is a significant change in the estimated boundaries of the prostate using any suitable method such as by comparing corresponding points of the updated selected CBS (which may be a most recent CBS) with the selected CBS before the (corresponding) modification and calculating an absolute value (CAV) of a difference between these points. Accordingly, if it is determined that the CAV is greater than a threshold distance value, the process may determine that there is a significant change in the estimated boundaries of the prostate.
Finally, page 15, paragraphs, [0138-0139] the present system may provide a user interface (UI) such as a graphical user interface (GUI) which may render a visualization of current as well as predicted catheter positions (e.g., as may be measured at the tracked tip of the catheter). The visualization may further include a representation of intersection points such as actual intersection points and/or estimated intersection points, planned trajectory, estimated trajectory, which may be superposed upon current live ultrasound imaging plane(s), arbitrary image planes, and/or pre-acquired reference image frames. In accordance with embodiments of the present system, spatial tracking of an ultrasound probe may be used to determine a position of a live ultrasound image in tracking space, the latter of which may be used to determine an intersection of predicted and/or actual catheter trajectory with live and/or “reference images”. Further, in accordance with some embodiments, in live transverse image planes, an intersection with the catheter trajectory (e.g., estimated) can be visualized by rendering a “marker” whose characteristics such as color, shape, size, intensity may be selected to indicate whether a tip of a corresponding catheter is in front of, at, or behind a current image plane (as shown in FIG. 8x));
And output puncture support information on the puncture needle to the ultrasound image on the basis of position/posture information of the puncture needle obtained by analyzing the puncture needle image marker (see above, also page 12, paragraphs, [0111-0115] a catheters and/or other objects are “inserted into the prostate”, the prostate may change its shape. Accordingly, the process may form or otherwise update deformation vectors in accordance with registration constraints so as to take into account the deformation of the prostate. If desired, the process may obtain information related to location and/or orientation of one or more catheters and/or portions thereof (e.g., distal ends) from sensors of the system such as may be location information. After completing act 419, the process may continue to act 421. As discussed above, as “needles are inserted into the prostate”, the prostate may change its shape (e.g., deform) and the process may update deformation vectors to take this change of shape into account. The process may calculate registration constraints which take into account the deformation of the prostate and update the deformation vectors according to the registration constraints. Then, the process may update the selected CBS in accordance with these updated deformation vectors so as to form a current CBS which may act as a modification contour which, as discussed above, may estimate the deformed boundaries of the prostate. After completing act 421, the process may continue to act 423. During act 423, the process may determine whether there is a significant change in the estimated boundaries of the prostate due to insertion one or more of the catheters into the prostate. Accordingly, if it is determined that there is a significant change in the estimated boundaries of the prostate, the process may continue to act 425.
Finally, page 15, paragraphs, [0138-0139] the present system may provide a user interface (UI) such as a graphical user interface (GUI) which may render a visualization of current as well as predicted catheter positions (e.g., as may be measured at the tracked tip of the catheter). The visualization may further include a representation of intersection points such as actual intersection points and/or estimated intersection points, planned trajectory, estimated trajectory, which may be superposed upon current live ultrasound imaging plane(s), arbitrary image planes, and/or pre-acquired reference image frames. In accordance with embodiments of the present system, spatial tracking of an ultrasound probe may be used to determine a position of a live ultrasound image in tracking space, the latter of which may be used to determine an intersection of predicted and/or actual catheter trajectory with live and/or “reference images”.
[0139] Further, in accordance with some embodiments, in live transverse image planes, an intersection with the catheter trajectory (e.g., estimated) can be visualized by rendering a “marker” whose characteristics such as color, shape, size, intensity may be selected to indicate whether a tip of a corresponding catheter is in front of, at, or behind a current image plane (as shown in FIG. 8x).
Regarding claim 2, Kruecker discloses the prostate puncture support device according to The prostate puncture support device according to wherein the processor is configured to perform registration between the reference volume image and the ultrasound image on the basis of position/posture information of the ultrasound probe (see claim 1, also pages 3 and 6, paragraphs, [0034] and [0058], it is envisioned that the 3D imaging (reference image), portion may include any suitable 3D imaging portion or portions such as an ultrasound imaging system, a magnetic resonance (MR) imaging (MRI) imaging portion, and/or a computed tomography (CT) imaging system. In accordance with yet other embodiments, image information obtained from one or more imaging sources, such as a TRUS probe and/or an MRI, may be “registered” so as to provide a composite image, if desired. In accordance with some embodiments, it is envisioned that the 3D reference dataset and/or portions thereof may be acquired using one or more imaging methods such as MRI, CT, MR, positron-emission tomography (PET), and/or ultrasound imaging methods. The acquired image information that may be obtained from multiple image acquisition sources may be registered to form all and/or a portion of the 3D the reference dataset, if desired. However, for the sake of clarity, it will be assumed that the 3D reference dataset is acquired using the TRUS probe described herein. For example, embodiments of the present system may translate functional information in real-time to provide a real-time guidance, if desired.
Also page 9, paragraphs, [0083] and [0096], the process may initialize an “image registration” process. Accordingly, the process may select at least one image slice (e.g., 2D image slice) of the reference dataset which is determined to be a best fit (e.g., a closest fit) to the current image. In other words, the process may estimate at least one of the (2D) image slice(s) (e.g., in the corresponding axial or sagittal planes) from the reference dataset, that best matches the current image in accordance with the location information. In accordance with some embodiments, the process may perform an image registration process to register the selected image slice from the reference dataset onto the current image (e.g., a live image). This image registration process may be performed using any suitable image registration method such as an automated registration algorithm).
Regarding claim 3, Kruecker discloses the prostate puncture support device according to The prostate puncture support device according to wherein the surgical field image further includes a probe image marker attached to the ultrasound probe, and the processor is configured to acquire the position/posture information of the ultrasound probe by analyzing the probe image marker included in the surgical field image (see claim 1, also page 15, paragraphs, [0138-0139] the present system may provide a user interface (UI) such as a graphical user interface (GUI) which may render a visualization of current as well as predicted catheter positions (e.g., as may be measured at the tracked tip of the catheter). The visualization may further include a representation of intersection points such as actual intersection points and/or estimated intersection points, planned trajectory, estimated trajectory, which may be superposed upon current live ultrasound imaging plane(s), arbitrary image planes, and/or pre-acquired reference image frames. In accordance with embodiments of the present system, spatial tracking of an ultrasound probe may be used to determine a position of a live ultrasound image in tracking space, the latter of which may be used to determine an intersection of predicted and/or actual catheter trajectory with live and/or “reference images”. Further, in accordance with some embodiments, in live transverse image planes, an intersection with the catheter trajectory (e.g., estimated) can be visualized by rendering a “marker” whose characteristics such as color, shape, size, intensity may be selected to indicate whether a tip of a corresponding catheter is in front of, at, or behind a current image plane (as shown in FIG. 8x)).
Regarding claim 4, Kruecker discloses the prostate puncture support device according to The prostate puncture support device according to wherein the surgical field image further includes a magnetic field generator image marker attached to a magnetic field generator, the ultrasound probe includes a magnetic sensor (see claim 1, also page 3, paragraphs, [0034-0036] the 3D imaging portion may include any suitable 3D imaging portion or portions such as an “ultrasound imaging system”, a magnetic resonance (MR) imaging (MRI) imaging portion, and/or a computed tomography (CT) imaging system. In accordance with yet other embodiments, image information obtained from one or more imaging sources, such as a TRUS probe and/or an MRI, may be registered so as to provide a composite image, if desired.
The sensors may include one or more sensors which may detect a position and/or orientation of one or more desired portions of the system such as positions of image capture devices (e.g., the TRUS probe or other image sensor(s)), a grid template, catheters, (e.g., implant catheters or portions thereof such as distal ends), the patient (or portions of the patient), etc. relative a desired reference frame and/or coordinate system. The sensors may then form corresponding sensor information and provide this sensor information to the controller for further processing. For example, the sensors and/or controller may determine a “position and/or orientation” of the TRUS probe as it acquires an image using any suitable method or methods such as an “electro-magnetic” (EM) and/or optical tracking methods (e.g., optical shape sampling). In accordance with some embodiments, the determined position and/or orientation of the TRUS probe may then be associated with the corresponding image information. For example, a position and/or orientation of the TRUS probe may be obtained using an electro-magnetic (EM) field generator an EM reference sensor or sensors which may form corresponding information indicative of a location of the TRUS probe 114.
Also page 15, paragraphs, [0138-0139] as well as predicted catheter positions (e.g., as may be measured at the tracked tip of the catheter). The visualization may further include a representation of intersection points such as actual intersection points and/or estimated intersection points, planned trajectory, estimated trajectory, which may be superposed upon current live ultrasound imaging plane. In accordance with embodiments of the present system, spatial tracking of an ultrasound probe may be used to determine a position of a live ultrasound image in tracking space, the latter of which may be used to determine an intersection of predicted and/or actual catheter trajectory with live and/or reference images. Further, in accordance with some embodiments, in live transverse image planes, an intersection with the catheter trajectory (e.g., estimated) can be visualized by rendering a marker whose characteristics such as color, shape, size, intensity may be selected to indicate whether a tip of a corresponding catheter is in front of, at, or behind a current image plane (as shown in FIG. 8x).
and the processor is configured to calculate the position/posture information of the ultrasound probe on the basis of position/posture information obtained by the magnetic sensor of the ultrasound probe and position/posture information of the magnetic field generator image marker attached to the magnetic field generator (see above, also page 7, paragraphs, [0065-0066] The PCIP may generally define points that correspond with a position where a portion of a catheter such as a distal end (e.g., a tracked distal end) of one or more of the catheters is estimated (e.g., expected or calculated) to intersect with an image plane of a 2D image slice and may extend only a threshold extension value (as may be defined by the system and/or user) beyond the image plane. The process may perform this act using any suitable placement method or methods. In accordance with some embodiments, the process may determine catheter range which may generally be a difference between of an actual location of a catheter (as may be measured at the tip of the catheter) and a current image plane or PCIP and provide a representation (e.g., alpha/numerical and/or graphical representation) of the result of the comparison for the convenience of the user).
Regarding claim 8, Kruecker discloses the prostate puncture support device according to The prostate puncture support device according to wherein the puncture support information for the puncture needle is a puncture guideline (see claim 1, also page 16, paragraphs, [0146-0147] embodiments of the present system may provide clinicians with quantitative knowledge of organ boundaries (e.g., of the prostate) during tool insertion in interventional therapy procedures (e.g., high-dose-rate (HDR) brachytherapy, cryotherapy, hyperthermia catheter insertion and the like). Accordingly, embodiments of the present system may be operative to decrease uncertainty associated with determining the organ boundaries and provide robust real-time image “guidance” during tool-insertion procedures. This may enhance accuracy of tool insertion. Embodiments of the present system may also reduce or eliminate the need for repeat tool insertion which may shorten clinical procedure time. Embodiments of the present system may provide a system and method which may provide a user interface (UI) with which a user may interact and which may render segmented images of an organ such as a prostate during catheter implantation in real time. Accordingly, embodiments, of the present system may generate and render a user interface (UI) which may include a visualization of a desired organ such as the prostate and its boundaries by slice to provide real-time guidance to a user such as a clinician during an interventional procedure in which one or more catheters may be inserted into the desired organ).
Regarding claim 9, Kruecker discloses the prostate puncture support device according to The prostate puncture support device according to wherein the processor is configured to superimpose the puncture support information, which includes a region of interest in the reference volume image and the puncture guideline, on the ultrasound image (see claim 1, also page 14, paragraphs, [0125-0126] form one or more composite images such as a current segmented live 2D TRUS image which may, for example, include the most current modified selected CBS “superimposed” upon the current image to form a composite image. For example, with reference to FIG. 5, the process may obtain the current image such as the image and superimpose the modification contour upon the current image to form a current segmented live 2D TRUS image. In accordance with some embodiments, the process may further superpose or superimpose information related to one or more of the PCIPs, estimated and/or actual trajectories, and/or parameters (e.g., catheter range, catheter settings, catheter trajectory, estimated and/or planned trajectories, etc.) of at least one of the catheters upon the current image (e.g., the live 2D TRUS image) or another representation of the current image, as may be desired by the system and/or user).
Regarding claim 10, Kruecker discloses the prostate puncture support device according to The prostate puncture support device according to wherein a region of interest in the acquired reference volume image is an entire image or a specific region, such as a target organ or a peripheral region (see abstract, an interventional therapy system may include at least one catheter configured for insertion within an object of interest (OOI); and at least one controller which: obtains a reference image dataset comprising a plurality of image slices which form a three-dimensional image of the OOI, defines restricted areas (RAs) within the reference image dataset, determines location constraints for the at least one catheter in accordance with at least one of planned catheter intersection points, a peripheral boundary of the OOI and the RAs defined in the reference dataset, determines at least one of a position and an orientation of the distal end of the at least one catheter, and/or determines a planned trajectory for the at least one catheter in accordance with the determined at least one position and orientation for the at least one catheter and the location constraints.
Also pages 6 and 9, paragraphs, [0056] and [0079], during act, the process may acquire a 3D reference image dataset of a volume-of-interest (VOI). The 3D reference image dataset (hereinafter reference dataset) may include a plurality of 2D image slices of the VOI in which a desired object-of-interest (OOI) such as a prostate of a patient may be located. Accordingly, the reference dataset may include N image slices of the desired OOI such as the prostate. These N image slices may be taken in one or more image planes. With other embodiments, it is envisioned that the current image (e.g., live or intra-procedural image) may be captured as 3D image information using a 3D probe. Accordingly, the 3D image information may then be processed similarly to the 2D image: It may be displayed, with surface or volume rendering, or using one or more 2D cross-sections through the 3D volume. Further, it is also envisioned that the segmented reference dataset may be used to initialize a segmentation in the current image, enabling real-time segmentation and visualization of the intra-procedural organ boundaries, and/or of any RAs, if desired).
Regarding claim 11, Kruecker discloses the prostate puncture support device according to The prostate puncture support device according to wherein the processor is configured to superimpose the puncture support information, which includes the ultrasound image, a region of interest in the reference volume image, and the puncture guideline, on the surgical field image (see claim 1, also page 14, paragraphs, [0125-0126] form one or more composite images such as a current segmented live 2D TRUS image which may, for example, include the most current modified selected CBS “superimposed” upon the current image to form a composite image. For example, with reference to FIG. 5, the process may obtain the current image such as the image and superimpose the modification contour upon the current image to form a current segmented live 2D TRUS image. In accordance with some embodiments, the process may further superpose or superimpose information related to one or more of the PCIPs, estimated and/or actual trajectories, and/or parameters (e.g., catheter range, catheter settings, catheter trajectory, estimated and/or planned trajectories, etc.) of at least one of the catheters upon the current image (e.g., the live 2D TRUS image) or another representation of the current image, as may be desired by the system and/or user).
Regarding claim 12, Kruecker discloses the prostate puncture support device according to The prostate puncture support device according to wherein the ultrasound image is a 3D ultrasound image, and the processor is configured to acquire position/posture information of a 2D ultrasound image using the probe image marker attached to the ultrasound probe and generate the 3D ultrasound image on the basis of the acquired position/posture information (see claim 1, also page 6, paragraphs, [0056-0058] the process may acquire a “3D reference image” dataset of a volume-of-interest (VOI). The 3D reference image dataset may include a plurality of 2D image slices of the VOI in which a desired object-of-interest (OOI) such as a “prostate” of a patient may be located. Accordingly, the reference dataset may include N image slices of the desired OOI such as the prostate. These N image slices may be taken in one or more image planes. For example, in accordance with some embodiments, the image slices may be in the sagittal plane while in other embodiments the image slices may be in the transverse or other plane or planes. The reference dataset may be acquired using any suitable “ultrasound imaging” apparatus such as a TRUS probe or the like. However, in yet other embodiments other types of imaging devices are also envisioned and may be used with and/or substituted for the TRUS probe. During acquisition of the reference dataset, the imaging apparatus (e.g., the TRUS probe) may be tracked (e.g., by sensors of the system) so that a position and/or orientation of the TRUS probe may be determined and associated with each corresponding 2D image slice acquired. These image slices may then be stacked to form a 3D reference dataset. In accordance with some embodiments, it is envisioned that the “3D (volume), reference” dataset and/or portions thereof may be acquired using one or more imaging methods such as MRI, CT, MR, positron-emission tomography (PET), and/or ultrasound imaging methods. The acquired image information that may be obtained from multiple image acquisition sources may be registered to form all and/or a portion of the 3D the reference dataset, if desired. However, for the sake of clarity, it will be assumed that the 3D reference dataset is acquired using the TRUS probe described herein. For example, embodiments of the present system may translate functional information in real-time to provide a real-time guidance, if desired.
Also page 12, paragraphs, [0114-0115], As discussed above, as “needles are inserted” into the prostate, the prostate may change its shape and the process may update deformation vectors to take this change of shape into account. The process may calculate registration constraints which take into account the deformation of the prostate and update the deformation vectors according to the registration constraints. Then, the process may update the selected CBS in accordance with these updated deformation vectors so as to form a current CBS which may act as a modification contour which, as discussed above, may estimate the deformed boundaries of the prostate. After completing act 421, the process may continue to act 423. During act 423, the process may determine whether there is a significant change in the estimated boundaries of the prostate due to insertion one or more of the catheters into the prostate. Accordingly, if it is determined that there is a significant change in the estimated boundaries of the prostate, the process may continue to act 425. However, if it is determined that there is no significant change in the estimated boundaries of the prostate, the process may continue to act 426. The process may determine that there is a significant change in the estimated boundaries of the prostate using any suitable method such as by comparing corresponding points of the updated selected CBS (which may be a most recent CBS) with the selected CBS before the (corresponding) modification and calculating an absolute value (CAV) of a difference between these points. Accordingly, if it is determined that the CAV is greater than a threshold distance value, the process may determine that there is a significant change in the estimated boundaries of the prostate.
Finally, page 15, paragraphs, [0138-0139] the present system may provide a user interface (UI) such as a graphical user interface (GUI) which may render a visualization of current as well as predicted catheter positions (e.g., as may be measured at the tracked tip of the catheter). The visualization may further include a representation of intersection points such as actual intersection points and/or estimated intersection points, planned trajectory, estimated trajectory, which may be superposed upon current live ultrasound imaging plane(s), arbitrary image planes, and/or pre-acquired reference image frames. In accordance with embodiments of the present system, spatial tracking of an ultrasound probe may be used to determine a position of a live ultrasound image in tracking space, the latter of which may be used to determine an intersection of predicted and/or actual catheter trajectory with live and/or “reference images”. Further, in accordance with some embodiments, in live transverse image planes, an intersection with the catheter trajectory (e.g., estimated) can be visualized by rendering a “marker” whose characteristics such as color, shape, size, intensity may be selected to indicate whether a tip of a corresponding catheter is in front of, at, or behind a current image plane (as shown in FIG. 8x)).
With regard to claims 13-15 the arguments analogous to those presented above for claims 1, 2, 3, 4, 8, 9, 10, 11 and 12, are respectively applicable to claims 13-15.
Allowable Subject Matter
Claims 5, 6 and 7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Seyed Azarian whose telephone number is (571) 272-7443. The examiner can normally be reached on Monday through Thursday from 6:00 a.m. to 7:30 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Matthew Bella, can be reached at (571) 272-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEYED H AZARIAN/Primary Examiner, Art Unit 2667
November 12, 2025
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