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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/27/2026 has been entered.
Response to Arguments
Regarding 35 U.S.C. 112
New 112(b) rejections necessitated by amendment.
Examiner notes that a majority of the previously set forth 112(b) rejections are withdrawn in view of the amendments to the claims, however, claim 14 remains rejected under 112(b) for recitation of the plurality of sets of adjustments without any arguments/amendments with respect thereto.
Regarding prior art
Applicant’s arguments with respect to claims 1, 4, 7, 13, 18, and 20 have been considered but are moot in view of the new grounds of rejection necessitated by amendment. Specifically Patwardhan is now relied upon for teaching the features of the independent claim(s).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 14-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 4 recites the limitation “simultaneously display the rendered volumetric ultrasound image and the secondary rendered volumetric ultrasound image”. It is unclear if the simultaneous displaying of the images is the same as the display operation of claim 1 or if this is a different “display” operation. In other words, it is unclear if the claim is attempting to further define the display operation of claim 1 to be or include simultaneously displaying the images or if the claim is attempting to set forth display of different information via the display operation and the simultaneous display. For examination purposes, it has been interpreted that they may be the same or different, however, clarification is required.
Claim 14 recites the limitation “the plurality of sets of adjustments”. There is insufficient antecedent basis for the limitation in the claim. It is unclear what plurality of sets of adjustments the limitation is attempting to refer to by reciting plurality of sets of adjustments. It is therefore unclear if the limitation intends to refer to the adjustment of the rendered volumetric image and the adjustment of the second rendered volumetric image or if these are a different plurality of sets of adjustments. Furthermore, it is unclear what “sets” refers to. For examination purposes, it has been interpreted to mean the adjustments to the rendered volumetric image and the adjustment of the second rendered volumetric image, however, clarification is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6-11, 16, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patwardhan et al. (US 20150164605 A1), hereinafter Patwardhan.
Regarding claims 1, 7, and 18,
Patwardhan discloses a system (at least fig. 1 (100) and corresponding disclosure in at least [0026]) comprising:
A probe (at least fig. 1 (108) and corresponding disclosure in at least [0028]), configured to receive volumetric ultrasound data about a tissue to be imaged ([0028] which discloses imaging subsystem 108 is configured to acquire a series of three-dimensional and/or four-dimensional ultrasound images corresponding to the subject).;
A memory storing instructions ([0049] which discloses embodiments of the exemplary method may be described in a general context of computer executable instructions on a computing system or a processor. Generally, computer executable instructions may include routines, programs, objects, components, data structures, procedures, modules, functions, and the like that perform particular functions or implement particular abstract data types and [0051] which discloses the blocks (i.e. of method 2 (200)) represent computer instructions that, when executed by one or more processing subsystems, perform the recited operations);
A processor (at least fig. 1 (120 and 128) and corresponding disclosure in at least [0031]. See also [0049]-[0051] disclosing aspects of the method 200 are performed by one or more processing subsystems and [0052] which discloses the exemplary method will be described with reference to the elements of fig. 1 as well as [0037] which discloses the system 100 may further include a video processor 128 that may be configured to perform one or more functions of the processing unit 120. For example, the video processor 128 may be configured to digitize the received echoes and output a resulting digital video stream on the display device 126), configured to execute the instructions to:
Acquire the volumetric ultrasound data obtained from the tissue (at least fig. 2 (202) and corresponding disclosure in at least [0054] and [0031] which discloses the processing unit 120 may be configured to receive and process the acquired image data, for example, the RF signals according to a plurality of selectable ultrasound imaging modes in near real-time and/or offline mode);
Process the volumetric ultrasound data to generate a volumetric ultrasound image, the volumetric ultrasound image comprising a plurality of image frames ([0035] which discloses processing unit 120 may be configured to process the RF signal data to generate the requested image-derived information based on user input. Particularly, the processing unit 120 may be configured to process the RF signal data to generate 2D, 3D, and/or four-dimensional (4D) datasets based on specific scanning and/or user-defined requirements. Additionally, in certain embodiments, the processing unit 120 may be configured to process the RF signal data to generate the volumetric images in real-time while scanning the target region and receiving corresponding echo signals. Examiner notes that generation of volumetric images in real-time constitutes a volumetric image comprising a plurality of frames);
Identify an anatomical feature of interest (at least fig. 2 (204) and corresponding disclosure in at least [0055] and [0040] which discloses the video processor 128 may be configured to identify one or more anatomical structures of interest form each volumetric image) and a plane on which the anatomical feature of is located ([0056] which discloses the labeled volumetric images may then be used to train the supervised learning method to identify the originally acquired view of the anatomical structures in incoming volumetric images and [0057] which discloses identifying the originally acquired view of the anatomical structures may also entail determining positions and orientations of the detected anatomical structures. In one embodiment, the positions and orientations of the anatomical structures in the originally acquired view may be determined, for example, based on segmentation or an HOG-based analysis); and
Determine a target orientation of the plane (at least fig. 2 (206) and corresponding disclosure in ate last [0058] and the optimal view may define a clinically useful spatial configuration of the anatomical structures in the volumetric image. The clinically useful spatial configuration may define a desired position and/or a desired orientation of the anatomical structures in the volumetric image that may be advantageously used to perform the desired imaging task. [0039] which discloses The desired FOV may correspond to an imaging plane that satisfies one or more statutory, clinical, application-specific, and/or user-defined specifications, thereby allowing for real-time tracking of the interventional device 130, accurate measurements of the patient anatomy, and/or efficient evaluation of the target structure 10); and
Automatically adjust, in the plurality of image frames, an orientation of the rendered volumetric ultrasound image, such the plane is adjusted to align with the target orientation (at least fig. 2 (208 and 210) and corresponding disclosure in at least [0045] and [0061]-[0063] as well as [0040] which discloses the video processor 128 may be configured to process the acquired volumetric image to automatically reposition and/or reorient the volumetric image to allow for optimal visualization of the target structure 102, [0043] which discloses the video processor 128 may rotate and/or reorient the volumetric image such that the anatomical structure such as the pulmonary vein may be positioned and/or oriented on the display device 126 to allow for real-time tracking and/or guidance for movement of the interventional device 130 within one or more cardiac chambers of the heart. See also [0022] which discloses for automatic customization of one or more imaging and/or viewing parameters that may be used to display the optimal view of the target structure. The specific imaging and/or viewing parameters to be customized may be determined based on the interventional procedure being performed. In one example, the imaging parameters may include a desired pulse sequence, a desired spatial location, a depth of acquisition, and/or a desired FOV of the target structure. Further, the viewing parameters may include viewing orientation, clipping planes, image contrast, and/or spatial resolution.); and
A display, configured to receive a signal from the processor and performing a display operation (at least fig. 2 (212) and corresponding disclosure in at least [0065])
Examiner notes that the system of Patwardhan would perform the method of claim 7 and comprise the non-transitory computer-readable medium of claim 18 each having corresponding method/execution steps to the system of claim 1.
Regarding claims 2 and 9,
Patwardhan further discloses further teaches wherein the processor is configured to execute the instructions to identify at least one additional anatomical feature of interest by identifying the anatomical feature of interest in the volumetric ultrasound data (at least fig. 2 (204) and corresponding disclosure in at least [0055] “one or more anatomical structures of interest”)
Regarding claims 3, 10-11, and 19,
Patwardhan further discloses wherein the adjusting the volumetric ultrasound image comprises: at least partially removing an anatomical feature obscuring the anatomical feature of interest in a viewing direction (adjusting a volumetric image includes at least partially removing an anatomical feature obscuring the anatomical feature of interest in a viewing direction (see at least fig. 2 (210) and corresponding disclosure in at least [0051] and [0044] which discloses Specifically, the video processor 128 may remove the obstructing regions in the volumetric image to render an optimal view that brings a relevant portion of the heart including the pulmonary vein into greater focus. See also [0063] disclosing obstructing structures in the volumetric image that occlude a view of one or more anatomical structures of interest)) and
maintaining the anatomical feature of interest always at a fixed location in the plurality of image frames ([0043] which discloses the video processor 128 may rotate and/or reorient the volumetric image such that the anatomical structure such as the pulmonary vein may be positioned and/or oriented on the display device 126 to allow for real-time tracking and/or guidance for movement of the interventional device 130 within one or more cardiac chambers of the heart. A suitable position and/or orientation of the pulmonary vein for use in providing relevant information for real-time tracking and/or guidance may be predetermined based on expert knowledge, user input, and/or historical medical information. See also [0059] which discloses In certain embodiments, the optimal view may define a clinically useful spatial configuration of the anatomical structures in the volumetric image. The clinically useful spatial configuration may define a desired position and/or a desired orientation of the anatomical structures in the volumetric image that may be advantageously used to perform the desired imaging task. The optimal view including the anatomical structures in the clinically useful spatial configuration may also allow for accurate measurement of biometric parameters and/or for an efficient assessment of a pathological condition of the subject and 212 where it is noted that the display displays the selected volumetric image including the optimal view in real-time, thus the at least one anatomical feature of interest is always at a fixed location (i.e. the desired position and/or desired orientation))
Regarding claims 6 and 16,
Patwardhan further discloses wherein the processor is further configured to calculate a difference between an orientation of the plane and the target orientation of each of an X-axis, a Y-axis, and a Z-axis, wherein the adjusting the orientation of the rendered volumetric ultrasound image comprises adjusting the orientation of the rendered volumetric ultrasound image based on the calculated differences ([0068] which discloses the selected volumetric image may undergo one or more processing steps such as image reorientation and removal of extraneous structures to minimize or reduce a difference between the determined position and/or orientation of the anatomical structures and the desired position and/or orientation of the of the anatomical structures defined in the optimal view. Certain examples of automated post-processing the volumetric images to generate an optimal view of the anatomical structures and/or to minimize the difference between the determined position and/or orientation and the desired position and/or orientation of the anatomical structures were previously described with reference to FIG. 2. Examiner notes that a person having ordinary skill in the art would have recognized determining a difference between the determined and desired position and/or orientation would require calculation between an orientation of the plane and the target orientation of each of an X-axis, a Y-axis, and a Z-axis accordingly. Furthermore, determining a difference in orientation is consistent with applicant’s own specification in at least [0050] and [0054]).
Regarding claim 8,
Patwardhan further discloses wherein the volumetric ultrasound data comes from at least one of a real-time ultrasonic scan and data in a memory ([0031] which discloses The processing unit 120 may be configured to receive and process the acquired image data, for example, the RF signals according to a plurality of selectable ultrasound imaging modes in near real-time and/or offline mode)
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.
Claims 4-5, 13-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Patwardhan in view of Lee et al. (US 20140003693 A1), hereinafter Lee.
Regarding claims 4, 13, and 20,
Patwardhan teaches the elements of claims 1, 7, and 18 as previously stated. Patwardhan further teaches identifying a secondary anatomical feature of interest;
Patwardhan fails to explicitly teach wherein the processor is configured to execute the instructions to identify a secondary plane on which the secondary anatomical feature is located, automatically adjust, in the plurality of image frames, an orientation of a secondary rendered volumetric ultrasound image such that the secondary plane is adjusted to align with a secondary target orientation; and simultaneously display the rendered volumetric ultrasound image and the secondary rendered volumetric ultrasound image corresponding to a same image frame from the plurality of image frames.
Lee, in a similar field of endeavor involving 3D ultrasound imaging, teaches wherein a processor is configured to execute instructions to identify a secondary plane on which a secondary anatomical feature is located ([0043] which discloses the diagnosis imaging apparatus may detect a first point and a second point on the heart wall of a valve of interest in the 3D volume data of the heart of a subject (Operation S110) and [0033] which discloses The image processing apparatus 110 rotates the 3D volume data 300 to make the virtual line 13 connecting the first point 11 and the second points 12 be parallel with the datum plane. Examiner notes that such rotation requires identifying a secondary plane on which a secondary anatomical feature is located),
automatically adjust an orientation of a secondary rendered volumetric ultrasound image such that a secondary plane is adjusted to align with a secondary target orientation ([0039] which discloses The image processing apparatus 110 may acquire a 3D standard view 3000S of the valve of interest by rotating the 3D image 3000 in a specific direction by a specific angle. The specific direction and the specific angle may be determined depending on the type of the valve of interest. For example, if the valve of interest is the mitral valve, the 3D image 3000 may be rotated around the X-axis by 90 degrees, and then be rotated counterclockwise by 90 degrees so that the 3D standard view 3000S of the mitral valve may be acquired);
And simultaneously displaying a first rendered volumetric ultrasound image (i.e. 3000S for aortic valve shown in fig. 4) and the secondary rendered volumetric ultrasound image (i.e. 3000S for mitral valve, pulmonary valve, or Tricuspid valve shown in fig. 4) corresponding to a same frame (see at least fig. 4).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Patwardhan to include adjusting an orientation of a secondary rendered volumetric ultrasound image such that the secondary plane is adjusted to align with a secondary target orientation and simultaneously displaying the secondary rendered volumetric ultrasound image as taught by Patwardhan in order to provide a desired field of view for other features of interest (e.g. valves) found in the 4D image data set. Such a modification would allow a physician to view multiple features of interest at the same time for the patient with an ideal field of view for each feature of interest thereby providing for enhanced overall diagnostics. Furthermore, such a modification amounts to merely duplication of parts (i.e. processing steps) related to additional features of interest, where a person having ordinary skill in the art would have recognized the motivation of doing so would provide for viewing of multiple features of interest at corresponding desired fields of view.
Regarding claims 5 and 14-15,
Patwardhan, as modified teaches the elements of claims 4 and 13 as previously stated. Patwardhan, as modified, further teaches wherein adjusting the rendered volumetric ultrasound image and the secondary rendered volumetric ultrasound image comprises adjusting target orientations (See [0040] of Patwardhan as well as fig. 4 of Lee ) and configuring different adjustment parameters for the plurality of sets of adjustments according to differences between the plurality of anatomical features of interest (see fig. 4 of Lee).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Patwardhan in view of Perrey et al. (US 20170238904 A1), hereinafter Perrey.
Regarding claim 12,
Patwardhan fails to explicitly teach storing an adjustment record for each image frame in the 4D ultrasound image.
Perrey, in a similar field of endeavor involving ultrasound imaging, teaches storing an adjustment record for an image frame ([0021] which discloses once the orientation of the volume is determined the volume may be automatically adjusted until it reaches the standard alignment, at which point it may be saved)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Patwardhan to include storing an adjustment record as taught by Perrey for each image frame in the volumetric ultrasound image of Weber in order to save the adjusted volume data for future processing and/or displaying diagnostically relevant slices/images in the future (Perrey [0021]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Patwardhan in view of Foreign Fujii (JP 2010068956 A), hereinafter Fujii. Examiner notes that citations to Fujii are with respect to the translated copy provided herein.
Regarding claim 17,
Weber teaches the elements of claim 7 as previously stated. Weber fails to explicitly teach in response to an adjusted volumetric ultrasound image being selected, displaying said image in an enlarged manner.
Fujii, in a similar field of endeavor involving ultrasound imaging, teaches
Wherein a plurality of adjusted volumetric ultrasound images are displayed simultaneously (see at least fig. 8 and corresponding disclosure in at least pg. 9 disclosing six ultrasonic images (all 3D displays) related to the fetus divided and displayed as moving images thus volumetric ultrasound images)
In response to an adjusted volumetric ultrasound image being selected, displaying said image in an enlarged manner (pg. 9 which discloses For example, the selected required ultrasound image can be enlarged and displayed).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Weber to include displaying a plurality of adjusted volumetric ultrasound images and displaying an image in an enlarged manner as taught by Fujii in order to selectively display only image data that is most efficient for examination from a plurality of viewing direction at the same time Fujii pg. 9).
Conclusion
Lee (KR 20150103956 A) teaches the image processing unit 110 can detect the plane of interest by searching a two-dimensional plane in which the anatomical organ is detected while moving the position of the two-dimensional plane in the three-dimensional brain image. For example, the image processing unit 110 can detect the cross section of interest while moving a two-dimensional plane to be photographed while photographing a three-dimensional brain image in real time. As another example, the image processing unit 110 may detect the cross section of interest by moving a two-dimensional plane in a stored three-dimensional brain image. The image processing unit 110 may store the detected cross section of interest in a predetermined storage unit by a user operation or automatically.
Li (US 11450003 B2) teaches identifying an anatomical feature of interest and a plane on which the anatomical feature is located (Col. 6 line 61-Col. 7 line 2 the structure extraction unit 230 includes a plane selection unit 231, a structure detection unit 232, and a structure determination unit 233. The plane selection unit 231 selects a plurality of planes from image data 240 such as volume data or time-series 2D continuous data. The structure detection unit 232 detects (identifies) the presence or absence of a region of a target structure in the plane by applying the learning model read by the model introduction unit 270 to the plane selected by the plane selection unit 231. The output unit 120 outputs the detected cross section of interest)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 5712700552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
Prosecution Insights