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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/26/2026 has been entered.
Acknowledgement of Amendment
The following office action is in response to the applicant’s amendment filed on 01/26/2026. Claims 1-13 and 16-18 are pending. Claims 14-15 were previously cancelled. Claims 1 and 17 are amended. Claims 1-13 and 16-18 are rejected under 35 U.S.C. 103 for the reasons stated in the Response to Arguments and 35 U.S.C. 103 sections below.
Response to Arguments
Applicant’s arguments, see Remarks page 7-9, filed 01/26/2026, with respect to the rejection of the claims under 35 U.S.C. 103 have been fully considered and are persuasive.
Regarding claims 1 and 17, the Applicant has amended the claims to recite: “wherein the holding device is moveable along a substantially straight line in physical space, the substantially straight line defining a spatial axis in physical space […] move the ultrasound transducer in a second pass along the spatial axis to acquire a second series of images at the respective series of positions along the spatial axis” (Claim 1) and “controlling the actuation subsystem and the ultrasound transducer to move the ultrasound transducer in a first pass along a substantially straight line in physical space, the substantially straight ling defining a spatial axis in physical space […] controlling the actuation subsystem and the ultrasound transducer to mode the ultrasound transducer in a second pass along the spatial axis and to acquire a second series of images at the respective series of positions along the spatial axis” (Claim 17).
The examiner acknowledges that these amendments are supported by the Applicant’s specification, specifically [Page 4, Lines 6-8].
At the outset, the Applicant sincerely appreciates the Examiner’s helpful comments and observations regarding the claim language that was employed in the previous responsive amendment. The amendments 1 and 17 are submitted to address a discrepancy between the literal claim wording and the inventive concept as consistently described in he application and as already understood by the Examiner in the context of the Applicant’s prior arguments. In particular, the clarification that the spatial axis is defined as a substantially straight line in physical space makes explicit that the claimed first and second passes are performed along one and the same scanline, rather than along multiple laterally displaced scan rows.
As clarified, the claims require that the ultrasound transducer is moved in a first pass and in a second pass along the same substantially straight line in physical space, acquiring images at the same series of positions along that line, while assuming different tilt angles before each pass. This clarification does not introduce a new technical limitation, but rather expresses more clearly the inventive concept already underlying the previous arguments regarding novelty and unobviousness advanced in the Applicant’s amendment data 09/23/2025.
As already explained in the Applicant’s remarks accompanying the previous amendment, Kelly performs successive scan rows that are laterally displaced from one another, with repositioning of the probe between passes. Each scan row in Kelly therefore corresponds to a different line in physical space. Even if movement during each scan row occurs in a direction referred to as an x-axis, the successive passes in Kelly are not performed along the same substantially straight line in physical space and do not acquire images at the same series of positions along such a line.
As a consequence, Kelly also fails to disclose or suggest acquiring multiple series of images at different tilt angles along the same scanline and at the same series of positions, as required by the pending claims herein. The amendments therefore reinforce, rather than alter, the previously presented arguments pertaining to patentability of the subject application, which remain fully applicable to the claims as amended.
The applicant therefore respectfully submits that the rejections advanced under 35 U.S.C. 103 have been fully traversed, and withdrawal of such rejections against the pending claims herein is respectfully requested.
The examiner respectfully acknowledges that the Applicant’s amendment clarifies that the spatial axis is defined by a substantially straight line in physical space (i.e. for example, along the tissue of a patient), which makes explicit that the claimed first and second passes are performed along one and the same scanline, rather than along multiple laterally displaced scan rows.
Furthermore, the examiner respectfully agrees that the prior art reference of Kelly performs imaging along multiple scan rows that are laterally displaced from one another (i.e. repositioning of the probe between passes, see [0040]). Thus, each scan row in Kelly corresponds to a different line in physical space (i.e. along the patient’s tissue). The examiner acknowledges that even if movement during each scan row occurs in a direction referred to as an x-axis, the successive passes in Kelly are not performed along the same substantially straight line in physical space and do not acquire images at the same series of positions along such a line.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Aaron et al. JP 2000500679 A “Aaron” as discussed in the 35 U.S.C. 103 section below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4, 7, 13, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al. US 2007/0073149 A1 “Kelly” and further in view of Lazebnik US 2011/0125022 A1 “Lazebnik” and Aaron et al. JP 2000500679 A “Aaron”.
Regarding claim 1, Kelly teaches “An ultrasound measurement system comprising:” (“As shown in FIG. 1, a preferred embodiment is comprised of a patient platform 2 to steady the patient and provide a base for the support member 4, the probe carrier 5 connected with the support member 4 that is capable of translation movement to guide the probe across the tissue to be scanned […] an associated probe 8, a remote control device 10 that operates the probe carrier [5]” [0031]; “The measurement system can be any means or convention and may consist of any or all of X, Y, Z-axes and/or the probe angular position” [0038]. Therefore, FIG. 1 shows an ultrasound measurement system.);
“an ultrasound transducer, […] for imaging a part of an anatomical structure” (“In order to obtain substantially parallel and contiguous images, a mechanical device holding the ultrasound probe 8 propels the probe across the tissue to be scanned at a uniform rate. In a preferred embodiment shown in FIG. 3, the probe carrier is mounted to a patient platform 16 that steadies the patient during the exam and acts as a base for the mechanical probe carrier” [0033]. This ultrasound probe 8 is shown in FIG. 1. In this case FIGS. 2 and 3 show support structures which support the ultrasound probe 8. Therefore, the ultrasound measurement system comprises an ultrasound transducer for imaging a part of an anatomical structure.);
“a support structure for being placed on or near a human or animal body which comprises the anatomical structure, wherein the support structure comprises a holding device for the ultrasound transducer, […] wherein the holding device is oriented so that a short axis of the ultrasound transducer is orthogonal to the spatial axis, and wherein the holding device is tiltable about the short axis of the ultrasound transducer” (“FIG. 2 depicts a plan view of a patient platform and probe carrier” [0016]; “FIG. 3 depicts a side view of a patient platform and probe carrier” [0017]; “In a preferred embodiment shown in FIG. 3, the probe carrier is mounted to a patient platform 16 that steadies the patient during the exam and acts as a base for the mechanical probe carrier. The carrier carriage 18 shown in FIGS. 2 and 3 is comprised of two parallel vertical members attached to rails 20 beneath the platform and a horizontal member that is attached to the top of the two vertical members, as shown in FIG. 4. The rails 20 allow the carriage 18 to move along the length of the platform, or the x-axis, as shown in FIGS. 2 and 3. Attached to the horizontal member between the two vertical members is another vertical member, called the carrier arm 22, with the carrier 24 holding an ultrasound probe 8 at its lower end. […] The carrier 24 itself is articulated to hold the probe at any desired angle relative to the patient by rotating about the x and y axes. The carrier 24 holds the probe 8 at a fixed angle during scanning. In another embodiment, the carrier 24 dynamically angles the probe 8 during the scanning process to keep it perpendicular to the patient's skin (or any other preferred orientation).” [0033]. Therefore, the patient platform 16 represents a support structure for being placed on or near a human or animal body which comprises the anatomical structure, wherein the support structure comprises a holding device (i.e. carrier carriage 18 in combination with the carrier arm 22 and the carrier 24, see FIGS. 2 and 3) for the ultrasound transducer (i.e. ultrasound probe 8), wherein the holding device is movable along a spatial axis in physical space (i.e. x-axis, shown in FIGS. 2 and 3), wherein the holding device is oriented so that a short axis (i.e. corresponding to the z-axis) of the ultrasound transducer is orthogonal to the spatial axis (i.e. x-axis, see FIGS. 2 and 3), and wherein the holding device is tiltable about the short axis of the ultrasound transducer (i.e. the carrier 24 holds the probe at any desired angle relative to the patient/dynamically angles the probe 8 to keep it perpendicular to the patient’s skin).);
“an actuation subsystem for moving the holding device and thereby the ultrasound transducer […] and for tilting the holding device and thereby the ultrasound transducer” (“In a preferred embodiment, the carriage 18 is propelled along the x-axis of the platform 16 during scanning by one or more motors that are controlled by a microprocessor. The carrier arm 22 is also moved along its two axes during scanning by one or more motors controlled by one or more microprocessors” [0034]; “The carrier 24 can be articulated to change the angular position of the probe 8 prior to or during scanning either manually, or by one or more motors controlled by one or more microprocessors” [0037]. Therefore, since the carriage 18 is propelled along the x-axis of the platform 16 by one or more motors, the carrier arm 22 is moved along two axes by one or more motors and the carrier 24 is articulated to change the angular position of the probe by one or more motors, the system includes an actuation subsystem for moving the holding device (i.e. carriage 18 in combination with the carrier arm 22 and the carrier 24) and thereby the ultrasound transducer along the spatial axis (i.e. x-axis, see FIGS. 2 and 3) and for tilting the holding device and thereby the ultrasound transducer.);
“a processing subsystem configured to, using the actuation subsystem and the ultrasound transducer:” (See “microprocessor” in [0034] and [0037] above.);
“move the ultrasound transducer in a first pass […] to acquire a first series of images at a respective series of positions […]” (“The speed of the carrier 24 holding the probe 8 is precisely controlled by a microprocessor, and the speed is correlated with the capture rate of the ultrasonic scanning device 6. The uniform speed of the carrier 24 results in images that are uniformly spaced, which allows the viewing program (discussed below) to calculate the position of a selected point on any image. […] The ultrasound scanning device 6 acts as a controller in communication with the probe 8 to sequentially activate the probe 8 as it moves across the tissue” [0039]. Therefore, the carrier 24 is controlled by the microprocessor (i.e. processing subsystem) to move the ultrasound transducer in a first pass (i.e. x-axis, see FIGS. 2 and 3) to acquire a first series of images at a respective series of positions, using the actuation subsystem (i.e. one or more motors) and the ultrasound transducer (i.e. ultrasound probe 8).);
“move the ultrasound transducer in a second pass along […] to acquire a second series of images at the respective series of positions […]” (“In current practice, the width of the tissue scanned by the ultrasound probe is generally too small to capture an image of an entire organ, such as the breast. As a result, several adjacent passes are performed to provide complete coverage. Each pass (called a scan row) will have some overlap with the preceding pass, to achieve full coverage and eliminate the potential for missing features at the fringes of the scan. Prior to each successive pass, the carrier arm 22 lifts away from the patient, moves along the y-axis across the breast and along the x-axis to the top of the breast to position itself for the next scan row, then lowers itself along the z-axis onto the patient“ [0040] and “A scan row contains a plurality of individual images or frames, typically about 200 to 300 for a breast” [0041]. Therefore, the microprocessor (i.e. processing subsystem) is configured to, using the actuation subsystem (i.e. one or more motors) and the ultrasound transducer (i.e. ultrasound probe 8), move the ultrasound transducer in a second pass (i.e. of the several adjacent passes/scan rows) along the respective spatial axis (i.e. x-axis, see FIGS. 2 and 3) to acquire a second series of images at the series of positions.); and
“before each pass, tilt the holding device to have the ultrasound transducer assume a first tilt angle during the first pass and a second tilt angle during the second pass” (See [0037], [0040] above and “The carrier 24 itself is articulated to hold the probe at any desired angle relative to the patient by rotating about the x and y axes. The carrier 24 holds the probe 8 at a fixed angle during scanning” [0033]. In this case, each scan row corresponds to a distinct pass of the ultrasound transducer along the patient. Since the carrier 24 can be articulated to change the angular position of the probe prior to scanning (i.e. see [0037]) along a scan row, and holds the probe at fixed angle during scanning along the scan row, the microprocessor (i.e. processing subsystem) is configured to, before each pass, tilt the holding device (i.e. specifically, the carrier 24 of the device including the carriage 18, carrier arm 22 and carrier 24) to have the ultrasound transducer assume a first tilt angle during the first pass and a second tilt angle during the second pass.).;
“generate a visualization of the part of the anatomical structure based on the first series of images and the second series of images” (“Rows appear in the image file in the order they are acquired, not necessarily the order in which they will ultimately be displayed by the viewer. Any number of scan rows may be included in an image file and there is no limit to the size of an image file. The data in an image file are laid out in such a manner that frames within a row are advanced in the order in which they will be displayed. This enables the viewer to do efficient read-ahead buffering during display for optimal viewing smoothness” [0066]; “Scan row frame elements stored in an image file are written in a format optimized for rapid rendering during display” [0067]; “After acquiring, converting, and storing the scan data, the second major task of the viewer is to display the scan images. The viewer opens a previously created image file and renders sequential scan row frames within its interface in a "movie-like" manner. […] The viewer arranges all scan rows such that they are displayed beginning with right lateral scan rows (arranged such that subsequent right lateral rows are progressively more lateral), and then proceeding to right medial scan rows (arranged such that subsequent rows are progressively more medial)” [0075]. Each of the scan rows corresponds to a different pass of the ultrasound probe 8 along the patient along the x-axis and contains a plurality of images (i.e. 200-300, see [0041]). Since the images in the image file are advanced in the order in which they will be displayed through read-ahead buffering and rapid rendering and the viewer displays the scan images by arranging the scan row frames in a movie-like manner, the processing subsystem is configured to generate a visualization of the part of the anatomical structure based on the first series of images and the second series of images.).
Kelly does not explicitly teach “wherein the ultrasound transducer is a B-mode ultrasound transducer”.
Lazebnik is within the same field of endeavor as the claimed invention because it involves a multi-dimensional ultrasound scanning device (see [Abstract]).
Lazebnik teaches “wherein the ultrasound transducer is a B-mode ultrasound transducer” (“The scanning may be for B-mode, color flow mode, tissue harmonic mode, contrast agent mode or other now known or later developed ultrasound imaging modes. Combinations of modes may be used, such as scanning for B-mode and Doppler mode data” [0075]. In order to perform B-mode scanning, the ultrasound transducer must be a B-mode ultrasound transducer.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound transducer of Kelly such that it is a B-mode ultrasound transducer as disclosed in Lazebnik in order to obtain B-mode images of the subject being examined. Performing B-mode imaging is one of a finite number of techniques which can be used to perform imaging such that the subject can be assessed with a reasonable expectation of success. Therefore, modifying the ultrasound transducer of Kelly such that it is a B-mode ultrasound transducer as disclosed in Lazebnik would yield the predictable result of obtaining B-mode images of the subject being examined.
Kelly in view of Lazebnik does not teach “wherein the holding device is movable along a substantially straight line in physical space, the substantially straight line defining a spatial axis in physical space”, or to move the ultrasound transducer in a first and second pass “along the spatial axis”.
Aaron is within the same field of endeavor as the claimed invention because it involves a holder which moves an ultrasonic probe (see FIG. 3).
Aaron teaches “wherein the holding device is movable along a substantially straight line in physical space, the substantially straight line defining a spatial axis in physical space” and moving the ultrasound transducer “along the spatial axis” (“The holder 22h moves the ultrasonic probe 24 at a fixed ratio along the linear scanning path Z. […] The ultrasonic probe 24 moves along the linear scanning path Z. It then emits an ultrasonic signal that strikes the target volume at a special, predetermined interval” [Page 3, Line 56-Page 4, Line 2]; “The computer 32 activates the probe activation assembly 22 to operate the ultrasonic probe. Control to sweep probe 24 along a linear scan path Z as desired” [Page 4, Lines 31-32]; “The ultrasonic probe 24 is swept along the linear path Z, and the ultrasonic probe 24 Is at an angle α with respect to an axis perpendicular to the longitudinal axis of the linear scan path Z, The ultrasound image acquired by the sonic machine has an angle α (see FIG. 3b)” [Page 4, Lines 34-36]. This linear scanning path Z is shown in FIG. 3. As shown in FIG. 3, the ultrasonic probe 24 moves along the linear scanning path Z, wherein the tip of the ultrasonic probe 24 moves along the layer of binding gel 22k attached to the patient. Therefore, Aaron discloses that the holding device (i.e. holder 22h) is movable along a substantially straight line in physical space (i.e. linear scanning path Z), the substantially straight line defining a spatial axis in physical space (i.e. along the patient, P). Furthermore, the ultrasound transducer is moved along the spatial axis (i.e. linear scanning path Z along the patient P).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound measurement system of Kelly in view of Lazebnik and Aaron such that the holding device is movable along a substantially straight line in physical space, the substantially straight line defining a spatial axis in physical space and moving the ultrasound transducer along the spatial axis, (i.e. in the first and second passes), as disclosed in Aaron in order to enable multiple images to be obtained for use in assessing a patient. Performing multiple scans along one substantially straight line in physical space (i.e. defining a spatial axis in physical space) is one of a finite number of techniques which can be used to enable a user to obtain images with which to assess a patient with a reasonable expectation of success. Thus, modifying the ultrasound measurement system of Kelly in view of Lazebnik and Aaron such that the holding device is movable along a substantially straight line in physical space, the substantially straight line defining a spatial axis in physical space and moving the ultrasound transducer along the spatial axis as disclosed in Aaron would yield the predictable result of enabling multiple images to be obtained for use in assessing a patient.
Regarding claim 4, Kelly in view of Lazebnik and Aaron discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kelly further teaches “wherein the processing subsystem is configured to acquire three or more series of images in three or more passes using three or more different tilt angles” (“A scan row contains a plurality of individual images or frames, typically about 200 to 300 for a breast. FIG. 5 depicts how the frames 28 in scan rows 30 are aligned on a typical breast scan, but for clarity, no overlap is shown. A scan row 30 can be thought of as a stack of photographic slides, each slide representing an individual frame 28. The frames 28 are evenly spaced. This may be accomplished by uniform motion of the probe 8 and uniform timing of the scans. The frames are most conveniently substantially parallel to each other” [0041]; “In a preferred embodiment, the viewer creates (and subsequently displays) proprietary image files, the format of which consists of a file header 72, a patient information block 74, and zero or more blocks of scan row frames 76, as shown in FIG. 8” [0064]. As shown in FIG. 5, there are three scan rows 30 (i.e. row 0, row 1, row 2), each including a plurality of evenly spaced frames 28 and FIG. 8 includes those rows and more (i.e. up to row N). Therefore, the processing subsystem is configured to acquire three or more series of images in three or more passes.
Additionally, since the carrier 24 can be articulated to change the angular position of the probe 8 prior to scanning (see [0037]) each of the passes/scan rows (see [0040]), the processing subsystem is configured to use three or more different tilt angles to acquire three or more series of images in three or more passes.).
Regarding claim 7, Kelly in view of Lazebnik and Aaron discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kelly further discloses “wherein the processing subsystem is configured to move the ultrasound transducer in consecutive passes […]” (“As a result, several adjacent passes are performed to provide complete coverage. Each pass (called a scan row) will have some overlap with the preceding pass, to achieve full coverage and eliminate the potential for missing features at the fringes of the scan” [0040]. Therefore, the processing subsystem is configured to move the ultrasound transducer in consecutive passes (i.e. several adjacent passes).);
Lazebnik further teaches that consecutive passes are performed “in alternating direction along the spatial axis” (“The array is translated along a plane or curved plane and/or rotated. Due to motor operation and/or the device, the array may be moved back and forth between two limits, wobbling the array, within the probe housing” [0023]. Therefore, since the array is moved back and forth between two limits, the array (i.e. transducers 12, 16, see FIG. 1), the array moves in alternating directions along the spatial axis.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kelly such that the processing subsystem is configured to move the ultrasound transducer in consecutive passes in alternating directions along the spatial axis (i.e. back and forth) as disclosed in Lazebnik in order to obtain multiple images in different directions for use in assessing and/or diagnosing an anatomical structure. Moving an ultrasound probe back and forth in consecutive passes is one of a finite number of techniques which can be used to obtain images from an anatomical structure with a reasonable expectation of success. Thus, modifying the system of Kelly such that the processing subsystem is configured to move the ultrasound transducer in consecutive passes in alternating directions along the spatial axis (i.e. back and forth) as disclosed in Lazebnik would yield the predictable result of obtaining multiple images in different directions for use in assessing and/or diagnosing an anatomical structure.
Regarding claim 13, Kelly in view of Lazebnik and Aaron discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kelly further teaches “wherein the part of the anatomical structure is a tissue part” (“When used for breast tissue scanning, the operator will determine the amount of area of the breast for scanning” [0040]. Therefore, the part of the anatomical structure is a tissue part (i.e. breast tissue).).
Regarding claim 17, Kelly in view of Lazebnik and Aaron discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kelly further teaches “A computer-implemented method of ultrasound imaging for use with the ultrasound measurement system according to claim 1, comprising, at the processing subsystem of the ultrasound measurement system:” (“The above-described devices, the probe, scanner, carrier, and viewing program, can be combined to provide a method to scan for anomalies in cellular tissue, such as cancers. The tissue is scanned, and the user views the images on a computer, rapidly scanning through the images in a "movie-like" fashion” [0099]. Therefore, Kelly provides a computer-implemented method of ultrasound imaging for use with the ultrasound measurement system according to claim 1, comprising, the processing subsystem of the ultrasound measurement system (see [0031], [0038] and FIG. 1 as discussed in claim 1 above).);
“controlling the actuation subsystem and the ultrasound transducer to move the ultrasound transducer in a first pass […] in physical space and to acquire a first series of images at a respective series of positions […]” (See [0034], [0037] and [0039] as discussed with respect to claim 1 above. Therefore, the method carried out by the system involves controlling the actuation subsystem (i.e. one or more motors) and the ultrasound transducer to move the ultrasound transducer in a first pass along a spatial axis (i.e. x-axis) in physical space and to acquire a first series of images (i.e. plurality of frames, see [0039]) at a respective series of positions along the spatial axis.);
“controlling the actuation subsystem and the ultrasound transducer to move the ultrasound transducer in a second pass […] and to acquire a second series of images at the respective series of positions […]” (See [0037]; [0040], [0041] and [0033] as discussed with respect to claim 1 above. Therefore, the method carried out by the system involves controlling the actuation subsystem and the ultrasound transducer to move the ultrasound transducer in a second pass (i.e. several adjacent passes, see [0040]) along the spatial axis (i.e. x-axis, see FIGS. 2 and 3) and to acquire a second series of images at the series of positions along the spatial axis.);
“controlling the actuation subsystem to, before each pass, tilt the holding device to have the ultrasound transducer assume a first tilt angle during the first pass and a second tilt angle during the second pass” (See [0037], [0040] and [0033] as discussed with respect to claim 1 above. Therefore, the method carried out by the system involves controlling the actuation subsystem to, before each pass, tilt the holding device to have the ultrasound transducer assume a first tilt angle (i.e. change the angular position of the probe 8) during the first pass and a second tilt angle during the second pass.); and
“generating a visualization of the part of the anatomical structure based on the first series of images and the second series of images” (See [0066], [0067] and [0075] as discussed with respect to claim 1 above. Therefore, the method carried out by the system involves generating a visualization of the part of the anatomical structure based on the first series of images and the second series of images (i.e. corresponding to the scan rows).).
Kelly in view of Lazebnik does not teach moving the ultrasound transducer in a first pass and a second pass “along a substantially straight line in physical space, the substantially straight line defining a spatial axis in physical space”.
Aaron is within the same field of endeavor as the claimed invention because it involves a holder which moves an ultrasonic probe (see FIG. 3).
Aaron teaches moving the ultrasound transducer in a first pass and a second pass “along a substantially straight line in physical space, the substantially straight line defining a spatial axis in physical space” (“The holder 22h moves the ultrasonic probe 24 at a fixed ratio along the linear scanning path Z. […] The ultrasonic probe 24 moves along the linear scanning path Z. It then emits an ultrasonic signal that strikes the target volume at a special, predetermined interval” [Page 3, Line 56-Page 4, Line 2]; “The computer 32 activates the probe activation assembly 22 to operate the ultrasonic probe. Control to sweep probe 24 along a linear scan path Z as desired” [Page 4, Lines 31-32]; “The ultrasonic probe 24 is swept along the linear path Z, and the ultrasonic probe 24 Is at an angle α with respect to an axis perpendicular to the longitudinal axis of the linear scan path Z, The ultrasound image acquired by the sonic machine has an angle α (see FIG. 3b)” [Page 4, Lines 34-36]. This linear scanning path Z is shown in FIG. 3. As shown in FIG. 3, the ultrasonic probe 24 moves along the linear scanning path Z, wherein the tip of the ultrasonic probe 24 moves along the layer of binding gel 22k attached to the patient. Therefore, Aaron discloses that the holding device (i.e. holder 22h) is movable along a substantially straight line in physical space (i.e. linear scanning path Z), the substantially straight line defining a spatial axis in physical space (i.e. along the patient, P). Furthermore, the ultrasound transducer is moved along the spatial axis (i.e. linear scanning path Z along the patient P).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computer-implemented method of Kelly in view of Lazebnik and Aaron such that the ultrasound transducer is moved in first and second passes along a substantially straight line in physical space, the substantially straight line defining a spatial axis in physical space as disclosed in Aaron in order to enable multiple images to be obtained for use in assessing a patient. Performing multiple scans along one substantially straight line in physical space (i.e. defining a spatial axis in physical space) is one of a finite number of techniques which can be used to enable a user to obtain images with which to assess a patient with a reasonable expectation of success. Thus, modifying computer-implemented method of Kelly in view of Lazebnik and Aaron such that the ultrasound transducer is moved in first and second passes along a substantially straight line in physical space, the substantially straight line defining a spatial axis in physical space as disclosed in Aaron would yield the predictable result of enabling multiple images to be obtained for use in assessing a patient.
Regarding claim 18, Kelly in view of Lazebnik and Aaron discloses all features of the claimed invention as discussed with respect to claim 1 above, and Kelly further teaches “A non-transitory computer-readable medium comprising data representing a computer program, the computer program comprising instructions for causing a processor system to perform the method according to claim 17” (“The microprocessor(s) can be separate from the computer that operates the viewing program (described below), or the computer can be used for this purpose” [0034]. In this case, the computer that operates the viewing program represents a transitory or non-transitory computer-readable medium comprising data representing a computer program, the computer program comprising instructions for causing a processor system to perform the method according to claim 17 (see above).).
Claim(s) 2-3, 5-6, and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al. US 2007/0073149 A1 “Kelly”, Lazebnik US 2011/0125022 A1 “Lazebnik” and Aaron et al. JP 2000500679 A “Aaron” as applied to claim 1 above, and further in view of Ebata US 2024/0122576 A1 “Ebata”.
Regarding claims 2 and 3, Kelly in view of Lazebnik and Aaron discloses all features of the claimed invention as discussed with respect to claim 1 above. Although Kelly discloses “The carrier 24 itself is articulated to hold the probe at any desired angle relative to the patient by rotating about the x and y axes. The carrier 24 holds the probe 8 at a fixed angle during scanning” [0033] and the “carrier 24 can be articulated to change the angular position of the probe 8 prior to scanning” [0037], Kelly in view of Lazebnik and Aaron does not explicitly teach “wherein the first tilt angle and the second tilt angle differ in sign with respect to a neutral tilt angle” (Claim 2) or “wherein the first tilt angle and the second tilt angle are substantially identical in magnitude” (Claim 3).
Ebata is within the same field of endeavor as the claimed invention because it involves generating three-dimensional ultrasound images by from two-dimensional ultrasound images acquired while shifting an angle or a position of a scanning plane using a transducer array (see [Abstract]).
Ebata teaches “wherein the first tilt angle and the second tilt angle differ in sign with respect to a neutral tilt angle” (Claim 2) and “wherein the first tilt angle and the second tilt angle are substantially identical in magnitude” (Claim 3) (“In a case where the angle of the scanning plane is shifted using the two-dimensional transducer array 11, data of a transducer group extending in the azimuth direction of the two-dimensional transducer array 11 is delayed in the elevation direction, the scanning plane is sequentially steered by a predetermined angle, and the transmission and reception of the ultrasound beams is sequentially performed while the angle of the scanning plane is sequentially shifted in the elevation direction (for example, refer to FIG. 7A). As a result, the plurality of two-dimensional ultrasound images with different angles of the scanning plane are generated” [0090]; “For example, it is assumed that the parameter is set such that a steering angle is shifted in 31 steps from +15 degrees to −15 degrees in 1-degree increment in a case of a first mode, and a steering angle is shifted in 61 steps from +15 degrees to −15 degrees in 0.5-degree increments in a case of a second mode. In this manner, in the case of the second mode, the change amount of the angle or position of the scanning plane is extremely small” [0126]. As shown in FIG. 7A, the ultrasound probe 1 is shifted to obtain ultrasound images at different scan angles. Since the steering angle is shifted from +15 degrees to -15 degrees (i.e. first and second tilt angles at either 1-degree or 0.5 degree increments), the first tilt angle and the second tilt angle of the ultrasound probe 1 differs in sign with respect to a neural tilt angle (i.e. 0 degrees between +15° and -15° and the first tilt angle and the second tilt angle are substantially identical in magnitude.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kelly in view of Lazebnik and Aaron such that the first tilt angle and the second tilt angle differ in sign with respect to a neural tilt angle and are substantially identical in magnitude as disclosed in Ebata in order to scan a specific region of the anatomical structure being examined. Scanning an anatomical structure with an ultrasonic probe which shifts between +15° and -15° is one of a finite number of techniques which can be used to obtain multiple views for performing assessment and diagnosis thereof with a reasonable expectation of success. Thus, modifying the system of Kelly in view of Lazebnik and Aaron such that the first tilt angle and the second tilt angle differ in sign with respect to a neural tilt angle and are substantially identical in magnitude as disclosed in Ebata would yield the predictable result of scan a specific region of the anatomical structure such that multiple views are obtained for performing assessment and diagnosis.
Regarding claims 5 and 6, Kelly in view of Lazebnik and Aaron discloses all features of the claimed invention as discussed with respect to claim 4 above, however, the combination does not teach “wherein the three or more different tilt angles include a neutral tilt angle” (Claim 5) or “wherein each respective tilt angle is selected within a range of -20 to 20 degrees, preferably within a range of -15 to 15 degrees” (Claim 6).
Ebata teaches “wherein the three or more different tilt angles include a neutral tilt angle” (Claim 5) and “wherein each respective tilt angle is selected within a range of -20 to 20 degrees, preferably within a range of -15 to 15 degrees” (Claim 6) (See [0090] and [0126] as discussed with respect to claims 2 and 3 above. In this case, since the ultrasound probe angle is tilted between +15° and -15° in 1 or 0.5 degree increments to obtain multiple scan planes (see FIG. 7A), the three or more different tilt angles includes a neutral tilt angle (i.e. 0 degrees).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kelly in view of Lazebnik and Aaron such that the three or more different tilt angles include a neutral tilt angle (i.e. 0° between +15° and -15°) and each respective tilt angle is selected within a range of -20 to 20 degrees, preferably within a range of -15 to 15 degrees as disclosed in Ebata in order to scan a specific region of the anatomical structure being examined. Scanning an anatomical structure with an ultrasonic probe which shifts between +15° and -15° is one of a finite number of techniques which can be used to obtain multiple views for performing assessment and diagnosis thereof with a reasonable expectation of success. Thus, modifying the system of Kelly in view of Lazebnik such that the three or more different tilt angles include a neutral tilt angle (i.e. 0° between +15° and -15°) and each respective tilt angle is selected within a range of -20 to 20 degrees, preferably within a range of -15 to 15 degrees as disclosed in Ebata would yield the predictable result of scan a specific region of the anatomical structure such that multiple views are obtained for performing assessment and diagnosis.
Regarding claim 8, Kelly in view of Lazebnik and Aaron discloses all features of the claimed invention as discussed with respect to claim 1 above, however, the combination does not teach “wherein the processing subsystem is configured to generate the visualization by: reconstructing a 3D volume showing the imaged part of the anatomical structure based on the first series of images and the second series of images” or “visualizing the 3D volume, for example by generating 2D images representing intersections of the 3D volume along sagittal, coronal, and transversal planes and by visualizing the 2D images”.
Ebata teaches “wherein the processing subsystem is configured to generate the visualization by: reconstructing a 3D volume showing the imaged part of the anatomical structure based on the first series of images and the second series of images” (“In a case where the three-dimensional ultrasound image is generated, first, under the control of the apparatus control unit 36, the plurality of two-dimensional ultrasound images with different angles or positions of the scanning plane are generated by the two-dimensional image generation unit 31 from the reception signals obtained by sequentially performing the transmission and reception of the ultrasound beams while shifting the angle or position of the scanning plane using the transducer array 11 in a state where the ultrasound probe 1 is fixed by being in contact with the examination location of the subject (Step S11)” [0087]; “Then, by the three-dimensional image generation unit 43, the two-dimensional ultrasound images for which the motion of the ultrasound probe 1 is determined to be within the reference value by the motion determination unit 42 are extracted from among the plurality of two-dimensional ultrasound images, and the three-dimensional ultrasound image is generated (Step S13)” [0096]. Therefore, three-dimensional ultrasound images are generated from the plurality of two-dimensional ultrasound images. Therefore, the processing subsystem is configured to generate the visualization by reconstructing a 3D volume showing the images part of the anatomical structure based on the first series of images and the second series of images (i.e. obtained by the ultrasound probe of Kelly).); and
“visualizing the 3D volume, for example by generating 2D images representing intersections of the 3D volume along sagittal, coronal, and transversal planes and by visualizing the 2D images” (“Next, by the display control unit 33, under the control of the apparatus control unit 36, the predetermined processing is performed on the three-dimensional ultrasound image generated by the three-dimensional image generation unit 43, and the processed three-dimensional ultrasound image (static image) is displayed on the monitor 34 (Step S14)” [0097]. Therefore, the method carried out by the system involves visualizing the 3D volume, for example by generating 2D images representing intersections of the 3D volume along sagittal, coronal, and transversal planes and by visualizing the 2D images.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kelly in view of Lazebnik and Aaron such that the processing subsystem is configured to generate the visualization by reconstructing a 3D volume showing the imaged part of the anatomical structure, visualizing the 3D volume as disclosed in Ebata in order to better assess the scanned anatomical structure. Reconstructing a 3D volume from a series of two-dimensional images and displaying the 3D volume is one of a finite number of techniques which can be used to assess an anatomical structure with a reasonable expectation of success. Thus, modifying the system of Kelly in view of Lazebnik and Aaron such that the processing subsystem is configured to generate the visualization by reconstructing a 3D volume showing the imaged part of the anatomical structure, visualizing the 3D volume as disclosed in Ebata would yield the predictable result of forming 3D images for use in assessing the scanned anatomical structure.
Regarding claim 9, Kelly in view of Lazebnik, Aaron and Ebata discloses all features of the claimed invention as discussed with respect to claim 8 above, and Ebata further teaches “wherein the processing subsystem is configured to generate the 3D volume using a 3D reconstruction technique and using the respective tilt angles of the ultrasound transducer as parameters in the 3D reconstruction technique” (See [0087] and [0096] as discussed in claim 8 above. Therefore, the processing subsystem is configured to generate the 3D volume using a 3D reconstruction techniques (i.e. carried out by the three-dimensional image generation unit 43, see [0096]) and using the respective tilt angles (i.e. two-dimensional ultrasound images with different angles or positions, see [0087]) of the ultrasound transducer as parameters in the 3D reconstruction technique.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kelly in view of Lazebnik and Aaron such that the processing subsystem is configured to generate the 3D volume using a 3D reconstruction technique and using the respective tilt angles (see FIG. 7A, for example) of the ultrasound transducer as parameters in the 3D reconstruction technique as disclosed in Ebata in order to better assess the scanned anatomical structure. Reconstructing a 3D volume from a series of two-dimensional images and displaying the 3D volume is one of a finite number of techniques which can be used to assess an anatomical structure with a reasonable expectation of success. Thus, modifying the system of Kelly in view of Lazebnik and Aaron such that the processing subsystem is configured to generate the 3D volume using a 3D reconstruction technique and using the respective tilt angles (see FIG. 7A, for example) of the ultrasound transducer as parameters in the 3D reconstruction technique as disclosed in Ebata would yield the predictable result of forming 3D images for use in assessing the scanned anatomical structure.
Regarding claim 10, Kelly in view of Lazebnik, Aaron and Ebata discloses all features of the claimed invention as discussed with respect to claim 9 above, and Ebata teaches “wherein in the 3D reconstruction technique, reconstructed intensities from different series of images are assigned to different colour components of the 3D volume” (“The image processing unit 17 performs various kinds of image processing such as brightness correction, gradation correction, sharpness correction, image size correction, refresh rate correction, scanning frequency correction, and color correction according to a display format of the monitor 34, on the image signal input from the DSC 18 to generate the two-dimensional ultrasound image, and then outputs the two-dimensional ultrasound image on which the image processing has been performed, to the image memory 32 and the display control unit 33” [0057]. Therefore, since the image processing unit 17 performs various kinds of image processing including brightness correction and color correction to output two-dimensional ultrasound images which the three-dimensional image generation unit uses to generate the three-dimensional ultrasound image, in the 3D reconstruction technique, reconstructed intensities from different series of images are assigned to different color components of the 3D volume.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kelly in view of Lazebnik and Aaron such that the processing subsystem is configured to generate the 3D volume using a 3D reconstruction technique, wherein in the 3D reconstruction technique, reconstructed intensities from different series of images are assigned to different colour components of the 3D volume as disclosed in Ebata in order to better assess the scanned anatomical structure. Reconstructing a 3D volume from a series of two-dimensional images using a 3D reconstruction technique, reconstructed intensities from different series of images are assigned to different colour components (i.e. through brightness and colour correction, see Ebata: [0057]) and displaying the 3D volume is one of a finite number of techniques which can be used to assess an anatomical structure with a reasonable expectation of success. Thus, modifying the system of Kelly in view of Lazebnik and Aaron such that the processing subsystem is configured to generate the 3D volume using a 3D reconstruction technique and using the respective tilt angles (see FIG. 7A, for example) of the ultrasound transducer as parameters in the 3D reconstruction technique as disclosed in Ebata would yield the predictable result of forming 3D images for use in assessing the scanned anatomical structure.
Claim(s) 11-12, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al. US 2007/0073149 A1 “Kelly”, Lazebnik US 2011/0125022 A1 “Lazebnik” and Aaron et al. JP 2000500679 A “Aaron” as applied to claim 1 above, and further in view of Annangi et al. US 2022/0319006 A1 “Annangi”.
Regarding claim 11, Kelly in view of Lazebnik and Aaron discloses all features of the claimed invention as discussed with respect to claim 1 above, however, the combination does not teach “wherein the processing subsystem is further configured to: extract features pertaining to the part of the anatomical structure from corresponding parts of the first series of images and the second series of images” or “classify and/or segment the part of the anatomical structure using said extracted features”.
Annangi is within the same field of endeavor as the claimed invention because it involves using a deep neural network to process ultrasound video (see [0044]).
Annangi teaches “wherein the processing subsystem is further configured to: extract features pertaining to the part of the anatomical structure from corresponding parts of the first series of images and the second series of images” (“Method 500 begins at 505. At 505, method 500 identifies a region of interest in each frame of the ultrasound video acquired at 405. As discussed hereinabove, the region of interest in each frame may comprise the region of each ultrasound image frame depicting an aortic valve. Method 500 may therefore, identify the aortic valve in each frame of the ultrasound video. Further, at 510, method 500 extracts the identified region of interest in each frame. […] In order to identify, extract, and align or register the regions of interest throughout the ultrasound video, the ultrasound video may be processed by a deep neural network configured to perform aortic valve localization, such as a mask R-CNN of the ROI model module 212” [0044]. Therefore, the method carried out by the system involves extracting features (i.e. region of interest, aortic valve) pertaining to the part of the anatomical structure (i.e. the heart) from corresponding parts of the first series of images and the second series of images (i.e. obtained by the ultrasound probe of Kelly).); and
“classify and/or segment the part of the anatomical structure using said extracted features” (“FIG. 2 shows a block diagram illustrating an example system 200 including an image processing system 202 configured to classify an anatomical structure in ultrasound image frames, according to an embodiment” [0025]; “FIG. 4 shows a high-level flow chart illustrating an example method 400 for classifying an anatomical structure in ultrasound video, according to an embodiment. In particular, method 400 related to analyzing ultrasound video to classify a cardiac structure depicted in the ultrasound video as a bicuspid valve or a tricuspid valve” [0036]; “At 415, method 400 classifies a cardiac structure in the identified frames as a bicuspid valve or a tricuspid valve. Method 400 may classify the aortic valve as bicuspid or tricuspid, for example, by inputting each identified frame into a generative model and measuring a reconstruction error based on the output of the generative model. […] The generative models may be trained on images of tricuspid valves at the respective cardiac phases, such that the reconstruction error may be low when the cardiac structure depicted in the identified frames comprises a tricuspid valve but relatively high when the cardiac structure depicted in the identified frames comprises a bicuspid valve. Method 400 may thus classify the cardiac structure in each identified frame as a bicuspid valve or a tricuspid valve based on whether the reconstruction error is above or below an error threshold, respectively” [0039]. Therefore, the method carried out by the system involves classifying and/or segmenting the part of the anatomical structure (i.e. bicuspid or tricuspid valve) using said extracted features (i.e. the identified frame).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kelly in view of Lazebnik and Aaron such that the processing subsystem is further configured to extract features pertaining to the part of the anatomical structure and classify and/or segment the part of the anatomical structure using said extracted features as disclosed in Annangi in order to effectively identify features of the ultrasound images. Utilizing a deep neural network to extract features and classify them is one of a finite number of techniques which can be used to assess an anatomical structure with a reasonable expectation of success. Thus, modifying the system of Kelly in view of Lazebnik and Aaron such that the processing subsystem is further configured to extract features pertaining to the part of the anatomical structure and classify and/or segment the part of the anatomical structure using said extracted features as disclosed in Annangi would yield the predictable result of processing ultrasound images such that anatomical structures can be effectively assessed.
Regarding claim 12, Kelly in view of Lazebnik, Aaron and Annangi discloses all features of the claimed invention as discussed with respect to claim 11 above, and Annangi further teaches “wherein the processing subsystem is configured to classify and/or segment the part of the anatomical structure by using the extracted features as input to a machine learned model” (See [0044] as discussed in claim 11 above and “The ROI model module 212 may comprise a deep learning model (e.g., a deep learning neural network) and instructions for implementing the deep learning model to identify a desired ROI within an ultrasound image” [0027]. Therefore, the processing subsystem is configured to classify and/or segment the part of the anatomical structure (i.e. aortic valve, for example), by using the extracted features (i.e. in the identified frames, see [0039]) as input to a machine learned model.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kelly in view of Lazebnik and Aaron such that the processing subsystem is further configured to extract features pertaining to the part of the anatomical structure and classify and/or segment the part of the anatomical structure using said extracted features as input to a machine learned model as disclosed in Annangi in order to effectively identify features of the ultrasound images. Utilizing a deep neural network to extract features and classify them is one of a finite number of techniques which can be used to assess an anatomical structure with a reasonable expectation of success. Thus, modifying the system of Kelly in view of Lazebnik and Aaron such that the processing subsystem is further configured to extract features pertaining to the part of the anatomical structure and classify and/or segment the part of the anatomical structure using said extracted features as disclosed in Annangi would yield the predictable result of processing ultrasound images such that anatomical structures can be effectively assessed.
Regarding claim 16, Kelly in view of Lazebnik, Aaron and Annangi discloses all features of the claimed invention as discussed with respect to claim 12 above, and Annangi further teaches “wherein the machine learned model is one of a deep neural network, a rule-based classifier, a decision tree, a random forest or a gradient boosting machine” (See [0044] as discussed in claim 11 above and [0027] as discussed in claim 12 above. Therefore, the machine learned model it a deep neural network.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kelly in view of Lazebnik and Aaron such that the processing subsystem is further configured to extract features pertaining to the part of the anatomical structure and classify and/or segment the part of the anatomical structure using said extracted features as input to a machine learned model, the machine learned model being a deep neural network as disclosed in Annangi in order to effectively identify features of the ultrasound images. Utilizing a deep neural network to extract features and classify them is one of a finite number of techniques which can be used to assess an anatomical structure with a reasonable expectation of success. Thus, modifying the system of Kelly in view of Lazebnik such that the processing subsystem is further configured to extract features pertaining to the part of the anatomical structure and classify and/or segment the part of the anatomical structure using said extracted features with a deep neural network as disclosed in Annangi would yield the predictable result of processing ultrasound images such that anatomical structures can be effectively assessed.
Conclusion
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797