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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03-26-2026 has been entered. Claims 1-5, 9-11, and 13-20 remain pending in the current application.
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) 1-5, 9-11, 13-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fujisawa et al. (US 2021/0093303) in the view of Kruecker et al (WO 2021/099171).
Regarding claim 1, Fujisawa teaches an ultrasound diagnostic apparatus comprising (figure 1, para. 0024):
an ultrasound probe (figure 1, element 30, para. 0024; The ultrasonic diagnostic apparatus 1 includes a main body 10 as a medical image processing apparatus, an ultrasonic probe 30 as a scanner);
a position and posture sensing device configured to acquire position and posture information of the ultrasound probe (para. 0054; The type of the position sensor 40 attached to the ultrasonic probe 30 detects position data of itself, and outputs the position data to the main body 10. The position data of the position sensor 40 can also be regarded as the position data of the ultrasonic probe 30. The position data of the ultrasonic probe 30 includes a coordinate (X, Y, Z) of the ultrasonic probe 30 and a tilt angle (posture) from each axis); and
a processor configured to perform a first process including (para. 0025; The main body 10 of the ultrasonic diagnostic apparatus 1 includes a transmission/reception (T/R) circuit 11, a B-mode processing circuit 12, a Doppler processing circuit 13, an image generating circuit 14, an image memory 15, a network interface 16, processing circuitry 17, a main memory 18, an input interface 19, and a display 20.):
acquiring an ultrasound image representing a tomogram of a subject by transmitting and receiving an ultrasound beam using the ultrasound probe (paras. 0026 and 0029; The T/R circuit 11 has a transmitting circuit and a receiving circuit (not shown). Under the control of the processing circuitry 17, the T/R circuit 11 controls transmission directivity and reception directivity in transmission and reception of ultrasonic waves. Under the control of the processing circuitry 17, the B-mode processing circuit 12 receives the echo data from the receiving circuit, performs logarithmic amplification, envelope detection processing and the like, thereby generate data (two-dimensional (2D) or three-dimensional (3D) data) which signal intensity is presented by brightness of luminance.);
generating three-dimensional ultrasound image data of the subject based on the position and posture information of the ultrasound probe acquired by the position and posture sensing device and the ultrasound image (paras. 0040 and 0104; the acquiring function 171 stores the ultrasonic image data acquired in step ST1 in a three-dimensional arrangement in the 3D memory of the image memory 15 on the basis of the position data of the ultrasonic image data (step ST3). );
extracting three-dimensional structure information regarding a three-dimensional structure included in the three-dimensional ultrasound image data from the three-dimensional ultrasound image data (para. 0107; the deriving function 172 derives the organ shape of the entire target organ in the subject and the imaged organ region on the basis of the ultrasonic image data of one or multiple cross-sections arranged in the 3D memory of the image memory 15 (step ST5).);
estimating a position of an occupied region of the three-dimensional ultrasound image data of the subject by a position estimation model, trained in a position of the three-dimensional structure in the three-dimensional image data obtained by imaging the three-dimensional structure, based on the extracted three-dimensional structure information (paras. 0086 and 0107-0108; the deriving function 172 derives the organ shape of the entire target organ in the subject and the imaged organ region on the basis of the ultrasonic image data of one or multiple cross-sections arranged in the 3D memory of the image memory 15 (step ST5). The deriving function 172 inputs a large number of training data and performs learning to sequentially update the parameter data Pa. The training data is made up of a set of multiple ultrasonic image data (e.g., arbitrary cross-section data forming volume data) S1, S2, S3, . . . as training input data and organ shapes T1, T2, T3, . . . corresponding to each arbitrary cross-section data. The multiple ultrasonic image data S1, S2, S3, . . . constitutes a training input data group Ba. The organ shapes T1, T2, T3, . . . constitutes a training output data group Ca. the deriving function 172 derives the organ shape of the entire target organ in the subject and the imaged organ region on the basis of the ultrasonic image data of one or multiple cross-sections arranged in the 3D memory of the image memory 15 (step ST5). The determining function 173 determines a three-dimensional unimaged organ region on the basis of the partial organ shape included in the ultrasonic image data of one or multiple cross-sections arranged three-dimensionally in step ST3 and the entire organ shape derived in step ST5 (step ST6). The determining function 173 extracts an organ contour from ultrasonic image data of cross-sections arranged three-dimensionally, arranges the extracted organ contour in a three-dimensional manner, and collates the arranged one with a 3D model of the entire organ.),
determining whether a three-dimensional region of an observation target is comprehensively imaged based on the three-dimensional region and the estimated occupied region (paras. 0126-0129; The display control function 71 determines whether or not the ratio of the volume or contour of the unimaged organ region to the volume or contour of the entire organ shape derived in step ST15 is equal to or less than a threshold value (e.g. 20%). If it is determined as “YES” in step ST17, that is, if it is determined that the volume or contour ratio of the unimaged organ region is less than or equal to the threshold value, the display control function 71 displays on the display 20 that the data is sufficient with only a little missing data (step ST18). On the other hand, if it is determined as “NO” in step ST17, that is, if it is determined that the ratio of the volume of the unimaged organ region exceeds the threshold value, the display control function 71 displays on the display 20 information regarding the unimaged organ region for the operator, as in step ST8 shown in FIG. 9 (step ST19).); and
repeat the first process until the three-dimensional region is determined to have been comprehensively imaged (fig. 12, para.0129; the ultrasonic diagnostic apparatus 1, it is possible to present the operator the ratio of the volume or contour of the unimaged target region to the volume or contour of acquired from the entire derived target shape and with its coordinate and range in real time during imaging. As a result, it is possible to for the operator to proceed with imaging while confirming the ratio of the unimaged target region.).
However, Fujisawa fails to explicitly disclose that a three dimensional region an observation target which is input by a user.
Kruecker, in the same field of endeavor, teaches a three dimensional region an observation target which is input by a user (paras. 0048-0049 and 0083; the organ model 174 used by the screening processor 170 may be selected by a user via the user interface 124. In some examples, the organ model 174 may include data corresponding to an organ model image (e.g., 2D or 3D), a shape of the organ model (e.g., wire mesh), and/or an organ model coordinate system (e.g., origin, axes). The control panel 152 may be configured to receive user inputs (e.g., exam type, organ model, information calculated by and/or displayed from the screening processor 170). Example techniques for calculating the coverage data for generating coverage maps or other representations of the coverage data are shown in FIGS. 10A-C. In some examples, a voxel- based volumetric model of the organ may be used (e.g., voxelation method). The volume occupied by the organ model 174 may be divided into cubes (e.g., voxels) of a desired side length (e.g., 0.1 ... 20mm) and assigned “coverage values” of “0” if inside the organ model, and “-1” if outside. The dimensions of the voxels may be based on a slice thickness of the image frames in some examples. In other examples, the voxel dimensions may be based on other factors (e.g., resolution of FIG. 10A shows one slice 1000 of voxels 1002 encompassing a portion 1004 of the organ model. For ease of illustration, the cubes are shown in a single dimension. As shown in FIG. 10B, for each ultrasound image pose estimate, the intersection of the frame 1008 with the organ voxels is calculated. Each voxel 1002 inside the organ that is intersected by the frame is marked as “covered” by assigning a different “coverage value” to that voxel, e.g. “+1”. The examiner notes that the scan coverage map is determined based on images acquired by the ultrasound imaging system and the three dimensional region of a target region selected by the user (organ model).).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the three-dimensional structure region of an observation object of Fujisawa to incorporate the teaching Kruecker to include a user input selecting a three dimensional region of an observation target. Doing so will help in accurate estimation of the coverage of the scan of a desired region, where the coverage estimation will correspond to the only user selected region.
Regarding claim 2, Fujisawa teaches the ultrasound diagnostic apparatus according to claim 1, wherein the processor is configured to: extract a two-dimensional tomographic image from the three-dimensional ultrasound image data (para. 0042; in order to generate various 2D image data so as to display the volume data stored in the 3D memory on the display 20, the image generating circuit 14 performs processing for displaying the volume data on the 2D display and processing for displaying the 3D data three-dimensionally, with respect to the volume data. The image generating circuit 14 performs the processing such as volume rendering (VR) processing, surface rendering (SR) processing, MIP (Maximum Intensity Projection) processing, MPR (Multi Planer Reconstruction) processing, etc.); reconstruct the three-dimensional ultrasound image data of the subject based on the extracted two-dimensional tomographic image and the position and posture information of the ultrasound probe acquired by the position and posture sensing device (para. 0078; the deriving function 172 arranges the ultrasonic image data acquired by the acquiring function 171 in the image memory 15 as the 3D memory on the basis of the position data acquired by the position sensor 40); and extract the three-dimensional structure information from the reconstructed three-dimensional ultrasound image data (para. 0077; the deriving function 172 has a function of deriving a target shape and an imaged target region in the subject from multiple ultrasonic image data and multiple position data acquired by the acquiring function 171. For example, the deriving function 172 includes a function of deriving an organ shape and the imaged organ region in the subject from the ultrasonic image data of multiple cross-sections and their position data.).
Regarding claim 3, Fujisawa teaches the ultrasound diagnostic apparatus according to claim 1, further comprising: a monitor (figure 1, element 20, para. 0025) and wherein the processor is configured to: display a three-dimensional schema image (para. 0108; Note that the 3D model may be generated by acquiring the organ contour from volume data such as 3D-CT image data acquired in advance from the same subject (same patient), or may be a 3D model showing a general organ shape.); and display, in an emphasized manner in the three-dimensional schema image, the occupied region of the three-dimensional ultrasound image data (para. 0108; he determining function 173 extracts an organ contour from ultrasonic image data of cross-sections arranged three-dimensionally, arranges the extracted organ contour in a three-dimensional manner, and collates the arranged one with a 3D model of the entire organ. Then, the determining function 173 determines, as an unimaged organ region, a region acquired by removing the organ contour included in the already existing data area from the organ contour of the 3D model. Note that the 3D model may be generated by acquiring the organ contour from volume data such as 3D-CT image data acquired in advance from the same subject (same patient), or may be a 3D model showing a general organ shape. The examiner notes that the occupied region is emphasized by contouring the structure in the three-dimensional image and overlaying it with a 3D model).
Regarding claim 4, Fujisawa teaches the ultrasound diagnostic apparatus according to claim 2, further comprising: a monitor (figure 1, element 20, para. 0025) and wherein the processor is configured to: display a three-dimensional schema image (para. 0108; Note that the 3D model may be generated by acquiring the organ contour from volume data such as 3D-CT image data acquired in advance from the same subject (same patient), or may be a 3D model showing a general organ shape.); and display, in an emphasized manner in the three-dimensional schema image, the occupied region of the three-dimensional ultrasound image data (para. 0108; he determining function 173 extracts an organ contour from ultrasonic image data of cross-sections arranged three-dimensionally, arranges the extracted organ contour in a three-dimensional manner, and collates the arranged one with a 3D model of the entire organ. Then, the determining function 173 determines, as an unimaged organ region, a region acquired by removing the organ contour included in the already existing data area from the organ contour of the 3D model. Note that the 3D model may be generated by acquiring the organ contour from volume data such as 3D-CT image data acquired in advance from the same subject (same patient), or may be a 3D model showing a general organ shape. The examiner notes that the occupied region is emphasized by contouring the structure in the three-dimensional image and overlaying it with a 3D model).
Regarding claim 5, Fujisawa teaches the ultrasound diagnostic apparatus according to claim 3, wherein the processor is configured to sequentially synthesize the three-dimensional ultrasound image data based on the three-dimensional structure included in the three-dimensional ultrasound image data of which the position of the occupied region is estimated (para. 0108; The determining function 173 extracts an organ contour from ultrasonic image data of cross-sections arranged three-dimensionally, arranges the extracted organ contour in a three-dimensional manner, and collates the arranged one with a 3D model of the entire organ.).
Regarding claim 9, Fujisawa teaches the ultrasound diagnostic apparatus according to claim 3, wherein the processor is configured to specify a region that is not displayed in an emphasized manner and notify a user of the specified region (paras. 0108-0109; The determining function 173 extracts an organ contour from ultrasonic image data of cross-sections arranged three-dimensionally, arranges the extracted organ contour in a three-dimensional manner, and collates the arranged one with a 3D model of the entire organ. Then, the determining function 173 determines, as an unimaged organ region, a region acquired by removing the organ contour included in the already existing data area from the organ contour of the 3D model. Note that the 3D model may be generated by acquiring the organ contour from volume data such as 3D-CT image data acquired in advance from the same subject (same patient), or may be a 3D model showing a general organ shape. The determining function 173 determines whether or not there is an unimaged organ region (step ST7). If it is determined as “YES” in step ST7, that is, if it is determined that there is the unimaged organ region, the display control function 71 displays information regarding the unimaged organ region on the display 20 for the operator (step ST8). The information regarding the unimaged organ region may be the range of the ultrasonic beam determined to fill the unimaged organ region (display example (1) described below), or may include the body surface coordinate and posture (display examples (2) to (4) described later) of the ultrasonic probe 30 for imaging an unimaged organ region. Further, the display control function 71 displays the information for imaging the unimaged target region, thereby displaying the information regarding the unimaged target region, and/or three-dimensionally displays the unimaged target region.).
Regarding claim 10, Fujisawa teaches the ultrasound diagnostic apparatus according to claim 4, wherein the processor is configured to specify a region that is not displayed in an emphasized manner and notify a user of the specified region (paras. 0108-0109; The determining function 173 extracts an organ contour from ultrasonic image data of cross-sections arranged three-dimensionally, arranges the extracted organ contour in a three-dimensional manner, and collates the arranged one with a 3D model of the entire organ. Then, the determining function 173 determines, as an unimaged organ region, a region acquired by removing the organ contour included in the already existing data area from the organ contour of the 3D model. Note that the 3D model may be generated by acquiring the organ contour from volume data such as 3D-CT image data acquired in advance from the same subject (same patient), or may be a 3D model showing a general organ shape. The determining function 173 determines whether or not there is an unimaged organ region (step ST7). If it is determined as “YES” in step ST7, that is, if it is determined that there is the unimaged organ region, the display control function 71 displays information regarding the unimaged organ region on the display 20 for the operator (step ST8). The information regarding the unimaged organ region may be the range of the ultrasonic beam determined to fill the unimaged organ region (display example (1) described below), or may include the body surface coordinate and posture (display examples (2) to (4) described later) of the ultrasonic probe 30 for imaging an unimaged organ region. Further, the display control function 71 displays the information for imaging the unimaged target region, thereby displaying the information regarding the unimaged target region, and/or three-dimensionally displays the unimaged target region.).
Regarding claim 11, Fujisawa teaches the ultrasound diagnostic apparatus according to claim 5, wherein the processor is configured to specify a region that is not displayed in an emphasized manner and notify a user of the specified region (paras. 0108-0109; The determining function 173 extracts an organ contour from ultrasonic image data of cross-sections arranged three-dimensionally, arranges the extracted organ contour in a three-dimensional manner, and collates the arranged one with a 3D model of the entire organ. Then, the determining function 173 determines, as an unimaged organ region, a region acquired by removing the organ contour included in the already existing data area from the organ contour of the 3D model. Note that the 3D model may be generated by acquiring the organ contour from volume data such as 3D-CT image data acquired in advance from the same subject (same patient), or may be a 3D model showing a general organ shape. The determining function 173 determines whether or not there is an unimaged organ region (step ST7). If it is determined as “YES” in step ST7, that is, if it is determined that there is the unimaged organ region, the display control function 71 displays information regarding the unimaged organ region on the display 20 for the operator (step ST8). The information regarding the unimaged organ region may be the range of the ultrasonic beam determined to fill the unimaged organ region (display example (1) described below), or may include the body surface coordinate and posture (display examples (2) to (4) described later) of the ultrasonic probe 30 for imaging an unimaged organ region. Further, the display control function 71 displays the information for imaging the unimaged target region, thereby displaying the information regarding the unimaged target region, and/or three-dimensionally displays the unimaged target region.).
Regarding claim 13, Fujisawa teaches the ultrasound diagnostic apparatus according to claim 9, wherein the processor is configured to present a reference ultrasound image to be observed in the specified region (para. 0109; The determining function 173 determines whether or not there is an unimaged organ region (step ST7). If it is determined as “YES” in step ST7, that is, if it is determined that there is the unimaged organ region, the display control function 71 displays information regarding the unimaged organ region on the display 20 for the operator (step ST8). The information regarding the unimaged organ region may be the range of the ultrasonic beam determined to fill the unimaged organ region (display example (1) described below), or may include the body surface coordinate and posture (display examples (2) to (4) described later) of the ultrasonic probe 30 for imaging an unimaged organ region. Further, the display control function 71 displays the information for imaging the unimaged target region, thereby displaying the information regarding the unimaged target region, and/or three-dimensionally displays the unimaged target region.).
Regarding claim 14, Fujisawa teaches the ultrasound diagnostic apparatus according to claim 1, wherein the three-dimensional structure information includes a shape pattern of the three-dimensional structure (para. 0077; the deriving function 172 has a function of deriving a target shape and an imaged target region in the subject from multiple ultrasonic image data and multiple position data acquired by the acquiring function 171. For example, the deriving function 172 includes a function of deriving an organ shape and the imaged organ region in the subject from the ultrasonic image data of multiple cross-sections and their position data.).
Regarding claim 15, Fujisawa teaches the ultrasound diagnostic apparatus according to claim 2, wherein the three-dimensional structure information includes a shape pattern of the three-dimensional structure (para. 0077; the deriving function 172 has a function of deriving a target shape and an imaged target region in the subject from multiple ultrasonic image data and multiple position data acquired by the acquiring function 171. For example, the deriving function 172 includes a function of deriving an organ shape and the imaged organ region in the subject from the ultrasonic image data of multiple cross-sections and their position data.).
Regarding claim 16, Fujisawa teaches the ultrasound diagnostic apparatus according to claim 3, wherein the three-dimensional structure information includes a shape pattern of the three-dimensional structure (para. 0077; the deriving function 172 has a function of deriving a target shape and an imaged target region in the subject from multiple ultrasonic image data and multiple position data acquired by the acquiring function 171. For example, the deriving function 172 includes a function of deriving an organ shape and the imaged organ region in the subject from the ultrasonic image data of multiple cross-sections and their position data.).
Regarding claim 17, Fujisawa teaches the ultrasound diagnostic apparatus according to claim 4, wherein the three-dimensional structure information includes a shape pattern of the three-dimensional structure (para. 0077; the deriving function 172 has a function of deriving a target shape and an imaged target region in the subject from multiple ultrasonic image data and multiple position data acquired by the acquiring function 171. For example, the deriving function 172 includes a function of deriving an organ shape and the imaged organ region in the subject from the ultrasonic image data of multiple cross-sections and their position data.).
Regarding claim 19, Fujisawa teaches the ultrasound diagnostic apparatus according to claim 1, wherein the position and posture sensing device includes an inertial sensing device, a magnetic sensing device, or an optical sensing device (paras. 0054-0055; the posture of the ultrasonic probe 30 can be detected by a magnetic field transmitter (not shown) sequentially transmitting triaxial magnetic fields while the position sensor 40 sequentially receiving the magnetic fields.).
Regarding claim 20, Fujisawa teaches a control method of an ultrasound diagnostic apparatus, the control method comprising preforming a first process including:
acquiring position and posture information of an ultrasound probe (para. 0054; The type of the position sensor 40 attached to the ultrasonic probe 30 detects position data of itself, and outputs the position data to the main body 10. The position data of the position sensor 40 can also be regarded as the position data of the ultrasonic probe 30. The position data of the ultrasonic probe 30 includes a coordinate (X, Y, Z) of the ultrasonic probe 30 and a tilt angle (posture) from each axis);
acquiring an ultrasound image representing a tomogram of a subject by transmitting and receiving an ultrasound beam using the ultrasound probe (paras. 0026 and 0029; The T/R circuit 11 has a transmitting circuit and a receiving circuit (not shown). Under the control of the processing circuitry 17, the T/R circuit 11 controls transmission directivity and reception directivity in transmission and reception of ultrasonic waves. Under the control of the processing circuitry 17, the B-mode processing circuit 12 receives the echo data from the receiving circuit, performs logarithmic amplification, envelope detection processing and the like, thereby generate data (two-dimensional (2D) or three-dimensional (3D) data) which signal intensity is presented by brightness of luminance.);
generating three-dimensional ultrasound image data of the subject on the basis of the acquired position and posture information of the ultrasound probe and the acquired ultrasound image (paras. 0040 and 0104; the acquiring function 171 stores the ultrasonic image data acquired in step ST1 in a three-dimensional arrangement in the 3D memory of the image memory 15 on the basis of the position data of the ultrasonic image data (step ST3).),
extracting three-dimensional structure information regarding a three-dimensional structure included in the three-dimensional ultrasound image data from the generated three-dimensional ultrasound image data (para. 0107; the deriving function 172 derives the organ shape of the entire target organ in the subject and the imaged organ region on the basis of the ultrasonic image data of one or multiple cross-sections arranged in the 3D memory of the image memory 15 (step ST5).); and
estimating a position of a region occupied by the three-dimensional ultrasound image data of the subject by inputting the extracted three-dimensional structure information to a position estimation model trained in a position of the three-dimensional structure in the three-dimensional ultrasound image data obtained by imaging the three-dimensional structure (paras. 0086 and 0107-0108; the deriving function 172 derives the organ shape of the entire target organ in the subject and the imaged organ region on the basis of the ultrasonic image data of one or multiple cross-sections arranged in the 3D memory of the image memory 15 (step ST5). The determining function 173 determines a three-dimensional unimaged organ region on the basis of the partial organ shape included in the ultrasonic image data of one or multiple cross-sections arranged three-dimensionally in step ST3 and the entire organ shape derived in step ST5 (step ST6). he determining function 173 extracts an organ contour from ultrasonic image data of cross-sections arranged three-dimensionally, arranges the extracted organ contour in a three-dimensional manner, and collates the arranged one with a 3D model of the entire organ. The deriving function 172 inputs a large number of training data and performs learning to sequentially update the parameter data Pa. The training data is made up of a set of multiple ultrasonic image data (e.g., arbitrary cross-section data forming volume data) S1, S2, S3, . . . as training input data and organ shapes T1, T2, T3, . . . corresponding to each arbitrary cross-section data. The multiple ultrasonic image data S1, S2, S3, . . . constitutes a training input data group Ba. The organ shapes T1, T2, T3, . . . constitutes a training output data group Ca. The examiner notes that the deriving unit extracts the position and shape of structure from the three-dimensional images); and
determining whether a three-dimensional region of an observation target is comprehensively imaged based on the three-dimensional region and the estimated occupied region (paras. 0126-0129; The display control function 71 determines whether or not the ratio of the volume or contour of the unimaged organ region to the volume or contour of the entire organ shape derived in step ST15 is equal to or less than a threshold value (e.g. 20%). If it is determined as “YES” in step ST17, that is, if it is determined that the volume or contour ratio of the unimaged organ region is less than or equal to the threshold value, the display control function 71 displays on the display 20 that the data is sufficient with only a little missing data (step ST18). On the other hand, if it is determined as “NO” in step ST17, that is, if it is determined that the ratio of the volume of the unimaged organ region exceeds the threshold value, the display control function 71 displays on the display 20 information regarding the unimaged organ region for the operator, as in step ST8 shown in FIG. 9 (step ST19).); and
repeat the first process until the three-dimensional region is determined to have been comprehensively imaged (fig. 12, para.0129; the ultrasonic diagnostic apparatus 1, it is possible to present the operator the ratio of the volume or contour of the unimaged target region to the volume or contour of acquired from the entire derived target shape and with its coordinate and range in real time during imaging. As a result, it is possible to for the operator to proceed with imaging while confirming the ratio of the unimaged target region.).
However, Fujisawa fails to explicitly disclose that a three dimensional region an observation target which is input by a user.
Kruecker, in the same field of endeavor, teaches a three dimensional region an observation target which is input by a user (paras. 0048-0049 and 0083; the organ model 174 used by the screening processor 170 may be selected by a user via the user interface 124. In some examples, the organ model 174 may include data corresponding to an organ model image (e.g., 2D or 3D), a shape of the organ model (e.g., wire mesh), and/or an organ model coordinate system (e.g., origin, axes). The control panel 152 may be configured to receive user inputs (e.g., exam type, organ model, information calculated by and/or displayed from the screening processor 170). Example techniques for calculating the coverage data for generating coverage maps or other representations of the coverage data are shown in FIGS. 10A-C. In some examples, a voxel- based volumetric model of the organ may be used (e.g., voxelation method). The volume occupied by the organ model 174 may be divided into cubes (e.g., voxels) of a desired side length (e.g., 0.1 ... 20mm) and assigned “coverage values” of “0” if inside the organ model, and “-1” if outside. The dimensions of the voxels may be based on a slice thickness of the image frames in some examples. In other examples, the voxel dimensions may be based on other factors (e.g., resolution of FIG. 10A shows one slice 1000 of voxels 1002 encompassing a portion 1004 of the organ model. For ease of illustration, the cubes are shown in a single dimension. As shown in FIG. 10B, for each ultrasound image pose estimate, the intersection of the frame 1008 with the organ voxels is calculated. Each voxel 1002 inside the organ that is intersected by the frame is marked as “covered” by assigning a different “coverage value” to that voxel, e.g. “+1”. The examiner notes that the scan coverage map is determined based on images acquired by the ultrasound imaging system and the three dimensional region of a target region selected by the user (organ model).).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the three-dimensional structure region of an observation object of Fujisawa to incorporate the teaching Kruecker to include a user input selecting a three dimensional region of an observation target. Doing so will help in accurate estimation of the coverage of the scan of a desired region, where the coverage estimation will correspond to the only user selected region.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Fujisawa et al. (US 2021/0093303) in the view of Kruecker et al (WO 2021/099171) and Yang et al. (US 2020/0229796).
Regarding claim 18, Fujisawa in the view of Kruecker teaches the ultrasound diagnostic apparatus according to claim 14, however, fails to explicitly teach wherein the three-dimensional structure information includes a brightness pattern of the three-dimensional structure.
Yang, in the same field of endeavor, teaches three-dimensional structure information includes a brightness pattern of the three-dimensional structure (paras. 0023-0024; 3D ultrasound can be used to measure aorta boundaries, such as estimate the AAA diameter perpendicular to the centering as well as the AAA volume. The systems and methods may perform 3D abdominal aorta segmentation based on a 3D vascular shape model and intensity model. The intensity model can also be defined by analyzing the ultrasound image brightness inside and outside the aorta structures.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the three-dimensional structure information of Fujisawa in the view of Kruecker to incorporate the teaching Yang to include a brightness pattern. Doing so will help in accurate segmentation of the structure based on intensity model as disclosed within Yang in para. 0023.
Response to Arguments
Applicant's arguments filed 03-26-2026 have been fully considered but they are not persuasive. The applicant argues that Fujisawa fails to disclose “repeating sequential process based on the determination of the unimaged organ region”. The examiner respectfully disagrees. Fujisawa disclose in figure 12 and paras. 0109, 0120, and 0126-0129, the deriving function 172 derives the organ shape of the entire target organ in the subject and the imaged organ region from the ultrasonic image data of one or multiple cross-sections arranged in the 3D memory of the image memory 15, as in step ST5 shown in FIG. 9 (step ST15). The determining function 173 determines a three-dimensional unimaged organ region on the basis of the ultrasonic image data of one or multiple cross-sections arranged in the 3D memory of the image memory 15, as in step ST6 shown in FIG. 9 (step ST16). The display control function 71 determines whether or not the ratio of the volume or contour of the unimaged organ region to the volume or contour of the entire organ shape derived in step ST15 is equal to or less than a threshold value (e.g. 20%). If it is determined as “YES” in step ST17, that is, if it is determined that the volume or contour ratio of the unimaged organ region is less than or equal to the threshold value, the display control function 71 displays on the display 20 that the data is sufficient with only a little missing data (step ST18). On the other hand, if it is determined as “NO” in step ST17, that is, if it is determined that the ratio of the volume of the unimaged organ region exceeds the threshold value, the display control function 71 displays on the display 20 information regarding the unimaged organ region for the operator, as in step ST8 shown in FIG. 9 (step ST19). It is possible to present the operator the ratio of the volume or contour of the unimaged target region to the volume or contour of acquired from the entire derived target shape and with its coordinate and range in real time during imaging. As a result, it is possible to for the operator to proceed with imaging while confirming the ratio of the unimaged target region. Therefore, Fujisawa disclose upon determining that an unimaged region is present, the processor calculates the ratio of the unimaged region to the imaged region (coverage percent) and displays information that the data is insufficient and instruction to acquire data of the unimaged region. Then the process loops back to acquiring images, analyzing them, calculating the coverage of the scan, and ending the process once sufficient data has been acquired (comprehensive coverage).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZAINAB M ALDARRAJI whose telephone number is (571)272-8726. The examiner can normally be reached Monday-Thursday7AM-5PM EST.
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/ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797
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