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 .
Status of Claims
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Claims 1-10 and 14 have been amended.
Claims 1-15 are currently pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite or similarly recite:
segment the anatomical structure in the region of interest based on both the first ultrasound imaging data and second ultrasound imaging data.
This claim limitation, as drafted and under its broadest reasonable interpretation, recites a mathematical concept. (MPEP 2106.04(a)(2)) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). For example, segmenting ultrasound data involves computations (e.g., thresholding, filtering, optimization), which are mathematical calculations that fall within the mathematical concept grouping.
This judicial exception is not integrated into a practical application. Additional elements to consider include:
(1) obtain first ultrasound imaging data representative of a region of interest including the anatomical structure, wherein the first ultrasound imaging data is acquired, by a beamforming unit, at a first resolution;
(2) obtain second ultrasound imaging data representative of an extended field-of-view, wherein the second ultrasound imaging data is acquired, by the beamforming unit, at a second, lower resolution, and the extended field-of-view comprises at least one region adjacent to the region of interest;
(3) a processing system;
(4) a transducer array;
(5) a beamforming unit configured to activate the transducer array.
These additional elements do not integrate the judicial exception into a practical application. Elements (1) and (2) are merely data gathering steps that also correspond to insignificant extra-solution activities (i.e., pre-solution activities) that do not impose any meaningfully limits on the claim. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(g)). (see, e.g., In re Bilski, 545 F.3d 943, 963 (Fed. Cir. 2008) (en banc), aff’d, 561 U.S. 593 (2010) (characterizing data gathering steps as insignificant extra-solution activity). Elements (3), (4), and (5) are recited at a very high level of generality and does not limit the claims in any meaningful way.
Moreover, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. (MPEP 2106.05). The additional elements include pre-solution activities that gather data for the subsequent mathematical calculations. Moreover, these additional elements are well-understood, routine, and conventional elements in image-processing. (see, e.g., the Section 103 rejection based on CLOUTIER and KLINDLE discussed below).
Accordingly, claim 1 (and claim 14) are directed to an abstract idea without significantly more.
Claim 2 recites that the processing system is further configured to obtain a definition of the region of interest and define the extended field-of-view based on the received definition of the region of interest. Obtaining the definition of the ROI is also an insignificant data gathering step. MPEP 2106.05(g). Defining the FOV based on the ROI definition is an abstract idea. Specifically, it recites a mathematical concept and/or mental process as it involves performing geometrical calculations and information analysis. (MPEP 2106.04(a))
Claim 3 recites that the processing system is further configured to acquire first ultrasound imaging data representative of the region of interest at the first resolution; and acquire second ultrasound imaging data representative of the extended field-of-view at the second, lower resolution. Again, acquiring ultrasound is an insignificant data gathering step. MPEP 2106.05(g). Moreover, controlling a beamforming unit merely indicates a field of use or technological environment for the judicial exception. (MPEP 2106.05(h)).
With respect to claim 4, control the beamforming units to acquire the first and second ultrasound imaging data merely indicates a field of use or technological environment for the judicial exception, (MPEP 2106.05(h)), that is also merely a data gathering step. (MPEP 2106.05(g)). Moreover, generating an image based on ultrasound data recites a mathematical concept. (MPEP 2106.04(a)(2)). Outputting the image to a user interface is insignificant extra-solution activity. (MPEP 2106.04(d)(I).
With respect to claims 5 and 6, control the beamforming units to acquire the first and second ultrasound imaging data merely indicates a field of use or technological environment for the judicial exception, (MPEP 2106.05(h)), that is also merely a data gathering step. (MPEP 2106.05(g)). Processing the data to determine one or more time-dependent anatomical characteristics and determining a time at which to acquire the second ultrasound imaging data based on the determined one or more time-dependent anatomical characteristics recite mathematical concepts. (MPEP 2106.04(a)(2)).
With respect to claim 6, obtaining, from one or more sensors, sensor data representative of the anatomical structure data merely indicates a field of use or technological environment for the judicial exception, (MPEP 2106.05(h)), that is also merely a data gathering step. (MPEP 2106.05(g)).
With respect to claims 7 and 8, generating images (combined image, first image, or second image) and segmenting the anatomical structure based on the combined images recites a mathematical concept. (MPEP 2106.04(a)(2)).
With respect to claim 9, redefining the extended field-of-view based on the segmentation recites a mathematical concept and/or mental process as it uses computed results to update an image. (MPEP 2106.04(a)(2)).
With respect to claim 10, the beamforming unit merely indicates a field of use or technological environment for the judicial exception, (MPEP 2106.05(h)), and it is also well-understood, routine, and conventional. (see, e.g., WAECHTER-STEHLE). Acquiring the first ultrasound imaging data by transmitting a first plurality of transmit pulses to the region of interest and acquiring the second ultrasound imaging data by transmitting a second plurality of transmit pulses to the extended field-of-view recite data gathering steps. (MPEP 2106.05(g)).
With respect to claims 11-13, the claim limitations regarding transmit pulses or transmit beams recite known ways for operating an ultrasound transducer and do not meaningfully limit the claims. (MPEP 2106.05(d)) (see, e.g., cited art for Section 103 rejections of claims 11-13).
With respect to claim 14, the computer program product merely indicates a field of use or technological environment for the judicial exception, (MPEP 2106.05(h)), and it is also well-understood, routine, and conventional. (see, e.g., WAECHTER-STEHLE).
Accordingly, claims 1-15 are directed to an abstract idea without significantly more and are not patent eligible.
RESPONSE TO APPLICANT’S ARGUMENTS:
Applicant alleges that claim 1 constitutes patentable subject matter per the streamlined analysis of Alice/Mayo and relies, in part, on the system including hardware limitations. (p.8 of Response). Examiner disagrees that the “eligibility of the claim is self-evident….” (MPEP 2106.06). The hardware limitations relied upon by Applicant are not recited with any specificity. While the claims are limited to ultrasound imaging technology, the claims are not limited to any particular workflow or type(s) of examination. Ultrasound has very broad applications with respect to medical imaging and segmentation is a common technique. Claim 1’s eligibility is not self-evident as further evidenced by the discussion below.
Applicant also alleges that claim 1 does not recite a judicial exception (specifically a mathematical concept) and, instead, merely describes the relationship between the data received and obtained via technological means (i.e., ultrasound transducer technology). (p.9 of the Response). Examiner disagrees. (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). In this case, mathematical concepts are necessarily required. For example, Applicant’s disclosure describes several “algorithms” and other mathematical concepts, such as boundary identification, model-based mesh fitting, voxel-based classification, image fusion, and Gaussian smoothing, and gradient reduction. (see, e.g., [0122]). In fact, Applicant’s disclosure explicitly describes the segmentation being performed by a “segmentation algorithm.” (e.g., [0013] and [0016]).
Applicant also argues that claim 1 requires “much more…than mathematical algorithms” (p.9 of the Response) and refers again to the hardware limitations. Again, these limitations are not recited with any specificity such that the claims are essentially reciting the words “apply it” and/or generally linking the use of the judicial exception to a particular technological environment or field of use.
Applicant alleges that claim 1 contains multiple limitations that integrate the judicial exception into a practical application. Again, Applicant emphasizes the hardware limitations and also emphasizes the different beamformed imaging data using the different resolutions and focal zones. (p.10 of the Response). As discussed above, the hardware limitations are recited without any specificity such that the claims are essentially reciting the words “apply it” and/or generally linking the use of the judicial exception to a particular technological environment or field of use. (MPEP 2106.04(d)). While the claims recite imaging data having high and low resolutions and different focal zones there is no further limitation as to the meaning of high, low, or different.
Finally, Applicant argues that the claims recite significantly more than the judicial exception. Examiner disagrees. Each of the hardware limitations and the claim limitations with respect to the processing are well-understood, routine, or conventional (see, e.g., discussion below with respect to claim 1).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0060660 A1 (hereinafter “WAECHTER-STEHLE”) and U.S. Patent Appl. Publ. No. 2016/0287214 A1 (hereinafter “RALOVICH”) and U.S. Patent No. 7,925,064 B2 (hereinafter “CLOUTIER”).
WAECHTER-STEHLE teaches an ultrasound system for imaging a volumetric region comprising a region of interest (ROI). (Abstract). WAECHTER-STEHLE notes that ultrasound systems may be deployed with “so-called anatomical intelligence, which facilitates the automated detection of the ROI using an appropriate anatomical model, such as for example a heart model in case of ICE [intra-cardiac echography] procedures.” ([0004]). These models may have “one or more segmentation algorithms” that evaluate the ultrasound data and “identify the anatomical feature” within the data.” ([0004]). The ultrasound system includes an “ultrasound wave transmission” that is configurable by a plurality of “use cases” in which each use case is associated with a particular imaging procedure. (Abstract). “Such an ultrasound system may be
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(semi-)automatically configured in accordance with settings that are specific to a particular imaging procedure….” (Abstract).
With respect to claim 1, WAECHTER-STEHLE teaches an ultrasound system for segmenting an anatomical structure in ultrasound imaging data (Abstract; see also [0069] describing that the ultrasound system 100 may be programmed with “use cases” that each have an “anatomical model” that may include “one or more segmentation algorithms to facilitate automated detection of the ROI...”). The system comprising:
a transducer array. (“an ultrasound system for imaging a volumetric region comprising a region of interest comprising a probe having an ultrasound transducer array; an ultrasound wave controlling unit to the array and adapted to control ultrasound wave transmission….” ([0007]).
a beamforming unit (“the ultrasound wave controlling unit comprises a beamformer arranged to control ultrasound beam steering of the transmitted ultrasound wave.” ([0009])) configured to activate the transducer array in one or both of receive beamforming and transmit beamforming (Id. and [0018]: “In this embodiment increasing of the beam frequency transmitted over the region of interest allows the beamformer receiving the higher frequency echo signals originating from the ROI….”), the beamforming unit operable to vary a beamforming focal zone;
for segmenting an anatomical structure in ultrasound imaging data (Id, see also [0069] describing that the ultrasound system 100 may be programmed with “use cases” that each have an “anatomical model” that may include “one or more segmentation algorithms to facilitate automated detection of the ROI...”). WAECHTER-STEHLE also teaches that
a processing system (“image processor 68” see, e.g., [0042] and [0043]) configured to:
obtain first ultrasound imaging data representative of a region of interest including the anatomical structure, wherein the first ultrasound imaging data is acquired, by a beamforming unit, at a first resolution having a first focal zone. “[T]he beamformer provides the ultrasound image data having…[a] relatively high spatial resolution within the region of interest.” ([0017]).
obtain second ultrasound imaging data representative of an extended field-of-view, wherein the second ultrasound imaging data is acquired, by the beamforming unit, at a second, lower resolution having a second focal zone. “[T]he beamformer provides the ultrasound image data having a relatively low spatial resolution within the volumetric region….” ([0017]). As shown in Figure 5, the extended-field-view is taught by the volumetric region 131, which is larger than the ROI 132. “The probe 10 is used to acquire ultrasound images of the volumetric field of view 131. The transducer frequency controller 62 is responsive to the region of interest identifier 72 sets a relatively low frequency of the ultrasound beams steered within the volumetric field of view 131 and a relatively high frequency of the ultrasound beams steered within the volumetric region 132 surrounding the identified ROI 82′.” ([0074]). WAECHTER-STEHLE also teaches that the extended field-of-view comprises at least one region adjacent to the region of interest. Compare volumetric region 131 to ROI 132 that is within the volumetric region. The portions of the volumetric region 131 that surround the ROI 132 teach “at least one region adjacent to the region of interest.”
However, WAECHTER-STEHLE does not explicitly teach that the beamforming unit is operable to vary a beamforming focal zone and the step of acquiring, by the beamforming unit, the first and second ultrasound imaging data at first and second resolutions, respectively, having first and second focal zones, respectively. Nonetheless, WAECHTER-STEHLE teaches that the beamformer is capable of controlling ultrasound beam steering. ([0009]) and that the frequency controller is capable of adjusting a resonance frequency of each transducer in the array. ([0042]). WAECHTER-STEHLE further teaches “[i]n a particular embodiment, in which the operating frequency of the array 14 is adjustable, the transducer frequency controller 62 together with the beamformer adjusts the frequency of the beams steered within the volumetric region 132 surrounding the identified ROI in the volumetric field of view 131.”
However, in the same field of endeavor, RALOVICH teaches an ultrasound system for imaging a 3D volume of interest. In particular, RALOVICH teaches scanning a region within a larger volume. (Abstract). “The ultrasound beams sample the anatomy sparsely with a full-volume acquisition to locate the object. This location controls the image acquisition process. The ultrasound system automatically recognizes certain structures and optimizes the field-of-view and other imaging parameters. A series of spatially smaller volume of interest acquisitions are performed for the targeted area.” ([0015]). “The volume of interest defined by the scan region is used to generate images with a greater temporal and/or spatial resolution than scanning of the entire original volume.” (Abstract). “The volume of interest box is automatically determined from the whole field-of-view three-dimensional image, and subsequently only the focused volume of interest is scanned.” ([0014]). “Since the full volume is less frequently scanned, the temporal resolution of the volume of interest is relatively higher. Since the volume of interest is smaller, less time is needed to complete each scan. As a result, even greater temporal resolution may be provided.” ([0067]).
RALOVICH teaches acquiring, by the beamforming unit, the first and second ultrasound imaging data at first and second resolutions, respectively, having first and second focal zones, respectively. “The volume is scanned with scan settings having the different values than for the volume of interest. Any one or more (e.g., two or more) parameters have different values. For example, the line density, transmit power, frame-rate, line (scan) orientation, scan format, and/or transmit focus are different for the volume of interest scan than for the volume scan.” ([0069]). “The transmit beamformer 12 is configured to generate waveforms for a plurality of channels with different or relative amplitudes, delays, and/or phasing to focus a resulting beam at one or more depths. The waveforms are generated and applied to a transducer array with any timing or pulse repetition frequency. For example, the transmit beamformer 12 generates a sequence of pulses for different lateral and/or range regions. The pulses have a center frequency.” ([0090]).
It would have been obvious to one having ordinary skill in the art to modify the WAECHTER-STEHLE system to have a beamforming unit that is operable to vary the focal zone and to acquire, by the beamforming unit, the first and second ultrasound imaging data at first and second resolutions, respectively, having first and second focal zones, respectively. One having ordinary skill in the art would have been motivated to acquire the image data at different focal zones in order to acquire the full volume at a lower resolution, thereby being able to determine the general location of the object, and acquire the smaller volume of interest at the higher resolution, thereby providing greater detail to the pertinent anatomical structures. (see, e.g., [0015] and [0017] of RALOVICH). There would have been a reasonable expectation of success as RALOVICH teaches that the ultrasound system can successfully use different focal zones with different resolutions.
While WAECHTER-STEHLE teaches that the anatomical models may include segmentation algorithms (see, e.g., [0069]), WAECHTER-STEHLE does not explicitly teach that the processing system is configured to segment the anatomical structure in the region of interest based on both the first ultrasound imaging data and second ultrasound imaging data.
In the same field of endeavor, CLOUTIER is concerned with “Automatic Multi-dimensional Intravascular Ultrasound Image Segmentation Method.” (Title). CLOUTIER teaches a segmentation process that involves “an exploration method from a wide propagating area at low resolution to a reduced propagating area at high resolution….” (emphasis added) (Col. 6, lines 45-47). With respect to Figures 14A-14D, CLOUTIER teaches using lower resolution images to initialize segmentation. More specifically, CLOUTIER teaches “using a multi-scale segmentation approach to initialize a higher resolution data set with low resolution segmentation results of the same [imaging session].” (emphasis added) (Col. 19, lines 24-26). In one example, “lower resolution images are obtained by undersampling the original IVUS image.” (Col. 20, lines 35-38). “The segmentation results of a lower resolution representation of the IVUS data are mapped into the next level of resolution….” (Col. 20, lines 42-45). “These segmentation-mapped results are used to initialize the interface propagation at this higher resolution level (Operation 193 of FIG. 20). At a low-resolution level, a fast coarse exploration of a wide propagating area is performed to bring the propagating interfaces 132,134 closer to the desired boundaries 138 (Operation 201 of FIG. 21).” (Col. 20, lines 52-57). CLOUTIER notes that this “multiresolution and multiscale fast marching segmentation methods of FIGS. 20 and 21 generally allows to iteratively improve the accuracy of the detected boundaries without increasing the computation time.” (Col. 21, lines 13-16).
Although the above example is with respect to generated images, CLOUTIER also describes using the segmentation process with ultrasound image data. (see, e.g., “a digitizer in communication with the transducer for digitizing the image data…, a processor in communication with the memory and the calculator for simultaneously estimating the boundaries of the layers of the digitized image data by using a fast marching model based on the estimated probability functions.” (Col. 4, lines 49-57)).
It would have been obvious to one having ordinary skill in the art to modify the WAECHTER-STEHLE system to segment the anatomical structure in the region of interest based on both the first ultrasound imaging data and second ultrasound imaging data. One having ordinary skill in the art would have been motivated to configure the system to segment the two ultrasound image data sets that have already been acquired using an initial low-resolution to high-resolution segmentation process taught in CLOUTIER. The WAECHTER-STEHLE system incorporates automatic segmentation methods to automatically identify or help the user identify an ROI. Adding CLOUTIER’s process would provide a quicker more accurate method of segmentation, particularly for the embodiment in which the user first identifies the ROI prior to imaging the larger volumetric region. (see, e.g., [0087] of WAECHTER-STEHLE and [0017] of RALOVICH). There would have been a reasonable expectation of success as CLOUTIER teaches that the process can successfully use lower resolution image data that surrounds a ROI to facilitate segmenting higher resolution image data within the ROI.
With respect to claim 2, WAECHTER-STEHLE teaches wherein the processing system is further configured to: obtain a definition of the region of interest and define the extended field-of-view based on the received definition of the region of interest. “In the present embodiment the user identified parameters are exchanged between the ROI identifier and the image processer 68, wherein the image processor computes coordinates of the ROI 82′ [i.e., the image processor defines the ROI] and a volumetric region 132 (illustrated in FIG. 5) surrounding the identified ROI in the volumetric field of view 131 based on the generated identification data provided by the ROI identifier [i.e., the image processor defines the volumetric region based on the definition of the ROI].” ([0043]).
With respect to claim 3, WAECHTER-STEHLE teaches wherein the processing system is further configured to control the beamforming unit to: acquire first ultrasound imaging data representative of the region of interest at the first resolution; and acquire second ultrasound imaging data representative of the extended field-of-view at the second, lower resolution. “FIG. 5 illustrates the scanning of the volumetric region with a relatively low frequency of the ultrasound beams steered within the volumetric region outside of the region of interest and a relatively high frequency of the ultrasound beams steered within the region of interest;” ([0033]). NOTE: The beamforming system is at least partially responsible for steering the ultrasound beam. (see, e.g., [0065]; see also [0079]: “In the phased array case the beamforming is performed such that for each line that constitutes the image, an appropriate frequency for all the transducers is chosen such that a high frequency detail view 132′ image is imbedded in the wide view 80 image containing lower frequency lines.”).
With respect to claim 4 (depending from claim 3), WAECHTER-STEHLE teaches wherein the processing system is configured to: control the beamforming unit to acquire the first ultrasound imaging data. “In another embodiment an image of a volume of interest can be acquired initially with relatively high frequency beams, this volume of interest can be identified by the user as the ROI.” ([0087]). WAECHTER-STEHLE teaches wherein the processing system is configured to: generate an image of the region of interest based on the first ultrasound imaging data; output the generated image of the region of interest to a user interface. “Similar to previous embodiments these fields of view may be displayed either next to each other or in the spatial registration.” ([0087]). WAECHTER-STEHLE teaches wherein the processing system is configured to: control the beamforming unit to acquire the second ultrasound imaging data in response to receiving a user input. “Further, the user via the user interface can decrease the imaging frequency, relative to what was used for the ROI, in order to obtain a wide view image with higher penetration depth, wherein the wide view image comprises the ROI.” ([0089]).
With respect to claim 8, WAECHTER-STEHLE teaches generating a first image based on the first ultrasound imaging data and generating a second image based on the second ultrasound imaging data. “Both fields of view may be displayed to a user either next to each other as separate ultrasound images or in a spatial registration as one ultrasound image.” ([0022]) (see also [0079]: “An embedded real time high frequency detail view 132′ image is generated simultaneous to a real time low frequency wide view 80 image.”).
However, WAECHTER-STEHLE does not explicitly teach that the processing system is configured to segment the anatomical structure in the region of interest by: segmenting the anatomical structure based on the first and second images.
As discussed above, CLOUTIER teaches using lower resolution images to initialize segmentation of higher resolution images. “The segmentation results of a lower resolution representation of the IVUS data are mapped into the next level of resolution….” (Col. 20, lines 42-45). In one embodiment, the lower resolution images are previously generated images that have been undersampled. (see, e.g., Figure 14). CLOUTIER notes that this “multiresolution and multiscale fast marching segmentation methods of FIGS. 20 and 21 generally allows to iteratively improve the accuracy of the detected boundaries without increasing the computation time.” (Col. 21, lines 13-16).
It would have been obvious to one having ordinary skill in the art to modify the WAECHTER-STEHLE system to segment the two ultrasound images that have already been acquired using an initial low-resolution to high-resolution segmentation process taught in CLOUTIER. The WAECHTER-STEHLE system incorporates automatic segmentation methods to automatically identify or help the user identify an ROI. Adding CLOUTIER’s process would provide a quicker more accurate method of segmentation, particularly for the embodiment in which the user first identifies the ROI prior to imaging the larger volumetric region. (see, e.g., [0087] of WAECHTER-STEHLE). There would have been a reasonable expectation of success as CLOUTIER teaches that the process can successfully use lower resolution image data that surrounds a ROI to facilitate segmenting higher resolution image data within the ROI.
With respect to claim 10, WAECHTER-STEHLE teaches an ultrasound system (“ultrasound system 100”; see Figure 1 and [0041]) comprising: the processing system of claim 1; and a beamforming unit (“a beamformer 64” see Figure 1 and [0041]), configured to: acquire the first ultrasound imaging data by transmitting a first plurality of transmit pulses to the region of interest; and acquire the second ultrasound imaging data by transmitting a second plurality of transmit pulses to the extended field-of-view. “[T]he system comprising the phased array can continually acquire first all lines of the volumetric field of view 131 volume at low frequency and then all lines the volumetric region 132 surrounding the identified ROI 82 with higher frequency.” ([0079]).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0060660 A1 (hereinafter “WAECHTER-STEHLE”) and U.S. Patent Appl. Publ. No. 2016/0287214 A1 (hereinafter “RALOVICH”) and U.S. Patent No. 7,925,064 B2 (hereinafter “CLOUTIER”) as applied to claim 3 above, and further in view of U.S. Patent Appl. Publ. No. 2005/0177044 A1 (hereinafter “RUBIN”).
With respect to claim 5 (depending from claim 3), WAECHTER-STEHLE teaches wherein the processing system is configured to: control the beamforming unit to acquire the first ultrasound imaging data. “In another embodiment an image of a volume of interest can be acquired initially with relatively high frequency beams, this volume of interest can be identified by the user as the ROI.” ([0087]). WAECHTER-STEHLE teaches wherein the processing system is configured to: determine a time at which to acquire the second ultrasound imaging data based on the determined one or more time-dependent anatomical characteristics; “For example, the ultrasound system 100 may be adapted to apply an appropriate anatomical model to the ultrasound imaging data, such as for example a heart model that can identify the structure of a patient's heart in the ultrasound imaging data and follow changes in the heart's geometry, e.g. to extract functional cardiac parameters such as ejection volume or the like from a sequence of ultrasound images visualizing the cardiac cycle.” ([0059]). WAECHTER-STEHLE teaches wherein the processing system is configured to: control the beamforming unit to acquire the second ultrasound imaging data at the determined time. “[T]he detail view 132′ of the ROI 82 and the wide view 80 can be displayed next to each other. In cardiology application during heart imaging the display and acquisition of the ultrasound images may be synchronized with heart cycle….” ([0077]).
However, WAECHTER-STEHLE does not explicitly teach wherein the processing system is configured to process the first ultrasound imaging data to determine one or more time-dependent anatomical characteristics.
RUBIN teaches ultrasonic gating of cardiac CT scans. (Title). In particular, RUBIN teaches “a method and system for gating the acquisition of image data from a moving subject such that all views of the subject are acquired at substantially the same subject location.” (emphasis added) ([0011]). More specifically, RUBIN teaches that “[u]ltrasound is repeatedly directed at the object, and a cross-correlation is performed on received echo signals to objectively measure relative location of the object. A high cross-correlation between two echo signals indicates the object is in substantially the same location when the two echo signals are produced. In the case of cardiac gating the cross-correlation of echo signals is employed to determine a window of time during each cardiac cycle when the object of interest (e.g., a coronary artery) is relatively stationary at the same location.” RUBIN notes that the invention can be applied in a number of ways. ([0012]).
It would have been obvious to modify the WAECHTER-STEHLE system to process the first ultrasound imaging data to determine one or more time-dependent anatomical characteristics as taught in RUBIN. As stated in WAECHTER-STEHLE, it is desirable to synchronize display and acquisition of ultrasound data. ([0077]). RUBIN teaches various methods to achieve this gating of the image data. One would be motivated to use RUBIN’s teachings to address the design need noted by WAECHTER-STEHLE because there are a finite number of gating strategies, one of which includes using ultrasound data for gating. (MPEP 2144.05, II: “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.”)
With respect to claim 6 (depending from claim 3), WAECHTER-STEHLE does not teach most of the claim limitations. However, WAECHTER-STEHLE does teach that, after determining the time to acquire the second ultrasound signal, control the beamforming unit to acquire the second ultrasound imaging data at the determined time. “[T]he detail view 132′ of the ROI 82 and the wide view 80 can be displayed next to each other. In cardiology application during heart imaging the display and acquisition of the ultrasound images may be synchronized with heart cycle by an ECG gating.” ([0077]).
WAECHTER-STEHLE does explicitly teach wherein the processing system is configured to: wherein the processing system is configured to: obtain, from one or more sensors, sensor data representative of the anatomical structure; process the sensor data to determine one or more time-dependent anatomical characteristics; determine a time at which to acquire the second ultrasound imaging data based on the determined one or more time-dependent anatomical characteristics.
RUBIN teaches ultrasonic gating of cardiac CT scans. (Title). RUBIN notes that ECG gating is often used to determine the cardiac cycle. However, “ECG gating has an inherent, intrinsic problem, which is that ECG gating is based on the heart's changing electrical potential, whereas the activity being gated is the heart's physical motion.” ([0009]). To address this problem, RUBIN teaches “a method and system for gating the acquisition of image data from a moving subject such that all views of the subject are acquired at substantially the same subject location.” (emphasis added) ([0011]).
Nonetheless, RUBIN teaches that ECG signals can be simultaneously obtained to detect the start of the heart cycle. ([0033], [0034]). “For all of the scanning sequences, simultaneous ECG data is also obtained using two leads: one connected to the right anterior chest at approximately the 4th intercostal space in the mid-clavicular line and the other connected to the left anterior chest at approximately the 6th intercostal space mid-axillary line.” ([0033]). “The ECG R-wave is used to select the start of each cardiac cycle.” ([0034]). “As indicated at process block 200, when the ECG trigger signal is produced indicating the start of a cardiac cycle, an echo signal is acquired as described above and indicated by process block 202.” ([0036]).
It would have been obvious to one skilled in the art to modify the WAECHTER-STEHLE system to obtain ECG signal representing the start of the cardiac cycle and to use those signals to trigger ultrasound acquisition. One would be motivated to use RUBIN’s teachings to address the design need noted by WAECHTER-STEHLE because there are a finite number of gating strategies, one of which includes using ultrasound data with a trigger signal provided by the ECG signal. (MPEP 2144.05, II: “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.”)
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0060660 A1 (hereinafter “WAECHTER-STEHLE”) and U.S. Patent Appl. Publ. No. 2016/0287214 A1 (hereinafter “RALOVICH”) and U.S. Patent No. 7,925,064 B2 (hereinafter “CLOUTIER”) as applied to claim 3 above, and further in view of U.S. Patent Appl. Publ. No. 2016/0310090 A1 (hereinafter “KLINDER”).
With respect to claim 7, WAECHTER-STEHLE and CLOUTIER teach, as discussed above, wherein the processing system is configured to: segment the anatomical structure in the region of interest by: segmenting the anatomical structure from images or imaging data. Although neither WAECHTER-STEHLE nor CLOUTIER explicitly teach segmenting a combined image, WAECHTER-STEHLE does teach generating images of the region of interest and the extended field-of-view based on the first ultrasound imaging data and the second ultrasound imaging data. “An embedded real time high frequency detail view 132′ image is generated simultaneous to a real time low frequency wide view 80 image…the detail view 132′ of the ROI 82 and the wide view 80 are updated in real time, the system comprising the phased array can continually acquire first all lines of the volumetric field of view 131 volume at low frequency and then all lines the volumetric region 132 surrounding the identified ROI 82 with higher frequency. The acquired view can by further interleaved or interpolated into one ultrasound image.” (emphasis added) ([0079]).
KLINDER teaches “a method includes combining 3D pre-scan image data with volumetric image data from a volume scan. The 3D pre-scan image data was used to plan the volume scan, generating combined image data. The method further includes segmenting tissue of interest from the volumetric image data based on the combined image data.” ([0011]).
Like WAECHTER-STEHLE, KLINDER describes having a larger field of view that surrounds the ROI to provide additional context. “[T]he field of view of the volumetric scan image data [i.e., the ROI] is a sub-set of the field of view of the 3D pre-scan image data.” (emphasis added) ([0044]). “Because the scanned field of view is greater for the pre-scan image data relative to the volumetric image data, the registration transform between the two sets of 3D pre-scan image data, using the registration transform determined by the pre-scan registerer 122, generally, may result in an improved initialization and/or more accurate registration of the two sets of the volumetric image data relative to a configuration in which the volume registerer 126 registers the two sets of the volumetric image data without using this registration transform.” ([0045]).
Notably, KLINDER combines two images together to form a combined image and then that combined image is segmented. “A combiner 127 combines 3D pre-scan and volumetric image data, generating combined data. A segmentor 128 segment tissue of interest based on the combined data. As described in greater detail below, in one instance, the combined data, relative to the volumetric image data alone, may provide an image data set with additional context for the organ of interest, e.g., where only a sub-portion of the organ of interest is represented in the volume scan and/or one or more organs neighboring the organ of interest is not represented in the volume scan.” ([0047]). In one variation of KLINDER, each of the 3D pre-scan image and the volumetric image can be displayed and the combined image can be displayed as well. (see, e.g., [0108]). While KLINDER is particularly concerned with CT data, KLINDER does teach that the method can be amenable to other imaging modalities. ([0001]; see also [0061]).
It would have been obvious to one having ordinary skill in the art to modify the WAECHTER-STEHLE system, as modified by CLOUTIER, to segment a combined image of the ROI and the extended field-of-view. WAECHTER-STEHLE and CLOUTIER already teach generating a combined image of the ROI and the extended field-of-view, ([0079]), and segmenting the anatomical structure using either two generated images or two sets of image data. KLINDER confirms that it is also possible to segment a combined image formed from two generated images. One would have been motivated to segment the combined image for the particular embodiments of WAECHTER-STEHLE that already generate and display the combined image. There would have been a reasonable expectation of success because CLOUTIER already teaches that two separate images and two different image data sets can be segmented, and KLINDER confirms that it is also possible to segment a combined image formed from two generated images.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0060660 A1 (hereinafter “WAECHTER-STEHLE”) and U.S. Patent Appl. Publ. No. 2016/0287214 A1 (hereinafter “RALOVICH”) and U.S. Patent No. 7,925,064 B2 (hereinafter “CLOUTIER”) as applied to claim 1 above, and further in view of Xu et al. “Deep mouse: an end-to-end auto-context refinement framework for brain ventricle & body segmentation in embryonic mice ultrasound volumes.” 2020 IEEE 17th International Symposium on Biomedical Imaging (ISBI). IEEE, 2020. (hereinafter “XU”).
With respect to claim 9, WAECHTER-STEHLE does not explicitly teach wherein the processing system is further configured to redefine the extended field-of-view based on the segmentation.
XU teaches a segmentation process that includes “a novel deep learning based end-to-end auto-context refinement framework.” (Abstract). The process includes two stages. The first stage produces a first resolution segmentation of the brain ventricle and the body simultaneously. “The resulting probability map for each object (BV or body) is then used to crop a region of interest (ROI) around the target object in both the original image and the probability map to provide context to the refinement segmentation network.” (Id). The proposed method significantly reduced the inference time. (Id). The segmentation process is automatically initiated.
It would have been obvious to one skilled in the art to modify the WAECHTER-STEHLE system to include a follow-up segmentation process that, in response to a first segmented structure, crops the surrounding field of view to improve a subsequent segmentation process. One would have been motivated to add this feature in order to provide a better segmented structure. There would have been a reasonable expectation of success as both CLOUTIER and XU teach iterative segmentation processes.
Claims 11, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0060660 A1 (hereinafter “WAECHTER-STEHLE”) and U.S. Patent Appl. Publ. No. 2016/0287214 A1 (hereinafter “RALOVICH”) and U.S. Patent No. 7,925,064 B2 (hereinafter “CLOUTIER”) as applied to claim 10 above, and further in view of U.S. Patent Appl. Publ. No. 2014/0140600 A1 (hereinafter “DAIGLE”).
With respect to claim 11 (depending from claim 10), WAECHTER-STEHLE does not explicitly teach wherein the first plurality of transmit pulses is a plurality of overlapping transmit pulses and the second plurality of transmit pulses is a plurality of non-overlapping transmit pulses.
DAIGLE, however, teaches a method and related system for improving resolution and frame rate of ultrasound images that includes specifying individual element transmit characteristics for each transmit beam in a set of transmit beams. (Abstract). Regarding resolution, DAIGLE teaches that “signals from multiple overlapping transmit beams [can be combined] in the image formation process to improve image resolution.” ([0043]). “[I]mage formation using multiple overlapping transmit beam regions can provide enhanced spatial resolution.” ([0048]). Regarding frame rate, DAIGLE teachings permit “designing a set of transmit beams that cover the desired image field of interest with only a few partially or fully overlapping transmit beams, rather than the large number of beams required when only the beam axis is reconstructed. The use of fewer than 64 beams allows reduced acquisition times and higher frame rates.” (emphasis added) ([0047]).
Accordingly, DAIGLE teaches that various parameters can be modified depending upon one’s objective. “One can have very high frame rates (greater than 100 frames per second), using only a few transmit beams per frame, yet still obtain reasonable image quality, or typical frame rates (around 30 frames per second) with larger numbers of beams, providing the best image spatial and contrast resolution.” ([0071]).
It would have been obvious to one having ordinary skill in the art to modify WAECHTER-STEHLE so that the first plurality of transmit pulses is a plurality of overlapping transmit pulses (to provide higher resolution ultrasound data) and the second plurality of transmit pulses is a plurality of non-overlapping transmit pulses (to provide lower resolution ultrasound data). WAECHTER-STEHLE already teaches the desire to have a low resolution volumetric region that surrounds a high resolution ROI. Accordingly, one skilled in the art would select parameters to achieve those objectives. There would have been a reasonable expectation of success as DAIGLE teaches that parameters may be reconfigured to achieve better resolution or to achieve higher frame rates.
With respect to claim 14, WAECHTER-STEHLE teaches a method that is performed by a processing system in which the method includes: obtaining first ultrasound imaging data representative of a region of interest including the anatomical structure, wherein the first ultrasound imaging data is acquired, by a beamforming unit, at a first resolution. “[T]he beamformer provides the ultrasound image data having…[a] relatively high spatial resolution within the region of interest.” ([0017]).
WAECHTER-STEHLE also teaches that the method includes obtaining second ultrasound imaging data representative of an extended field-of-view, wherein the second ultrasound imaging data is acquired, by the beamforming unit, at a second, lower resolution. “[T]he beamformer provides the ultrasound image data having a relatively low spatial resolution within the volumetric region….” ([0017]). As shown in Figure 5, the extended-field-view is taught by the volumetric region 131, which is larger than the ROI 132. “The probe 10 is used to acquire ultrasound images of the volumetric field of view 131. The transducer frequency controller 62 is responsive to the region of interest identifier 72 sets a relatively low frequency of the ultrasound beams steered within the volumetric field of view 131 and a relatively high frequency of the ultrasound beams steered within the volumetric region 132 surrounding the identified ROI 82′.” ([0074]). WAECHTER-STEHLE also teaches that the extended field-of-view comprises at least one region adjacent to the region of interest. Compare volumetric region 131 to ROI 132 that is within the volumetric region. The portions of the volumetric region 131 that surround the ROI 132 teach “at least one region adjacent to the region of interest.”
However, WAECHTER-STEHLE does not explicitly teach acquiring, by the beamforming unit, the first and second ultrasound imaging data at first and second resolutions, respectively, having first and second focal zones, respectively. Nonetheless, WAECHTER-STEHLE teaches that the beamformer is capable of controlling ultrasound beam steering. ([0009]) and that the frequency controller is capable of adjusting a resonance frequency of each transducer in the array. ([0042]). WAECHTER-STEHLE further teaches “[i]n a particular embodiment, in which the operating frequency of the array 14 is adjustable, the transducer frequency controller 62 together with the beamformer adjusts the frequency of the beams steered within the volumetric region 132 surrounding the identified ROI in the volumetric field of view 131.”
However, in the same field of endeavor, RALOVICH teaches an ultrasound system for imaging a 3D volume of interest. In particular, RALOVICH teaches scanning a region within a larger volume. (Abstract). “The ultrasound beams sample the anatomy sparsely with a full-volume acquisition to locate the object. This location controls the image acquisition process. The ultrasound system automatically recognizes certain structures and optimizes the field-of-view and other imaging parameters. A series of spatially smaller volume of interest acquisitions are performed for the targeted area.” ([0015]). “The volume of interest defined by the scan region is used to generate images with a greater temporal and/or spatial resolution than scanning of the entire original volume.” (Abstract). “The volume of interest box is automatically determined from the whole field-of-view three-dimensional image, and subsequently only the focused volume of interest is scanned.” ([0014]). “Since the full volume is less frequently scanned, the temporal resolution of the volume of interest is relatively higher. Since the volume of interest is smaller, less time is needed to complete each scan. As a result, even greater temporal resolution may be provided.” ([0067]).
RALOVICH teaches acquiring, by the beamforming unit, the first and second ultrasound imaging data at first and second resolutions, respectively, having first and second focal zones, respectively. “The volume is scanned with scan settings having the different values than for the volume of interest. Any one or more (e.g., two or more) parameters have different values. For example, the line density, transmit power, frame-rate, line (scan) orientation, scan format, and/or transmit focus are different for the volume of interest scan than for the volume scan.” ([0069]). “The transmit beamformer 12 is configured to generate waveforms for a plurality of channels with different or relative amplitudes, delays, and/or phasing to focus a resulting beam at one or more depths. The waveforms are generated and applied to a transducer array with any timing or pulse repetition frequency. For example, the transmit beamformer 12 generates a sequence of pulses for different lateral and/or range regions. The pulses have a center frequency.” ([0090]).
It would have been obvious to one having ordinary skill in the art to modify the WAECHTER-STEHLE system to acquire, by the beamforming unit, the first and second ultrasound imaging data at first and second resolutions, respectively, having first and second focal zones, respectively. One having ordinary skill in the art would have been motivated to acquire the image data at different focal zones in order to acquire the full volume at a lower resolution, thereby being able to determine the general location of the object, and acquire the smaller volume of interest at the higher resolution, thereby providing greater detail to the pertinent anatomical structures. (see, e.g., [0015] and [0017] of RALOVICH). There would have been a reasonable expectation of success as RALOVICH teaches that the ultrasound system can successfully use different focal zones with different resolutions.
While WAECHTER-STEHLE teaches that the anatomical models may include segmentation algorithms (see, e.g., [0069]), WAECHTER-STEHLE does not explicitly teach that the method includes segmenting the anatomical structure in the region of interest based on both of the first ultrasound imaging data and second ultrasound imaging data.
In the same field of endeavor, CLOUTIER is concerned with “Automatic Multi-dimensional Intravascular Ultrasound Image Segmentation Method.” (Title). CLOUTIER teaches a segmentation process that involves “an exploration method from a wide propagating area at low resolution to a reduced propagating area at high resolution….” (emphasis added) (Col. 6, lines 45-47). With respect to Figures 14A-14D, CLOUTIER teaches using lower resolution images to initialize segmentation. More specifically, CLOUTIER teaches “using a multi-scale segmentation approach to initialize a higher resolution data set with low resolution segmentation results of the same [imaging session].” (emphasis added) (Col. 19, lines 24-26). In one example, “lower resolution images are obtained by undersampling the original IVUS image.” (Col. 20, lines 35-38). “The segmentation results of a lower resolution representation of the IVUS data are mapped into the next level of resolution….” (Col. 20, lines 42-45). “These segmentation-mapped results are used to initialize the interface propagation at this higher resolution level (Operation 193 of FIG. 20). At a low-resolution level, a fast coarse exploration of a wide propagating area is performed to bring the propagating interfaces 132,134 closer to the desired boundaries 138 (Operation 201 of FIG. 21).” (Col. 20, lines 52-57). CLOUTIER notes that this “multiresolution and multiscale fast marching segmentation methods of FIGS. 20 and 21 generally allows to iteratively improve the accuracy of the detected boundaries without increasing the computation time.” (Col. 21, lines 13-16).
Although the above example is with respect to generated images, CLOUTIER also describes using the segmentation process with ultrasound image data. (see, e.g., “a digitizer in communication with the transducer for digitizing the image data…, a processor in communication with the memory and the calculator for simultaneously estimating the boundaries of the layers of the digitized image data by using a fast marching model based on the estimated probability functions.” (Col. 4, lines 49-57)).
It would have been obvious to one having ordinary skill in the art to modify the WAECHTER-STEHLE system to segment the anatomical structure in the region of interest based on both the first ultrasound imaging data and second ultrasound imaging data. One having ordinary skill in the art would have been motivated to configure the system to segment the two ultrasound image data sets that have already been acquired using an initial low-resolution to high-resolution segmentation process taught in CLOUTIER. The WAECHTER-STEHLE system incorporates automatic segmentation methods to automatically identify or help the user identify an ROI. Adding CLOUTIER’s process would provide a quicker more accurate method of segmentation, particularly for the embodiment in which the user first identifies the ROI prior to imaging the larger volumetric region. (see, e.g., [0087] of WAECHTER-STEHLE and [0017] of RALOVICH). There would have been a reasonable expectation of success as CLOUTIER teaches that the process can successfully use lower resolution image data that surrounds a ROI to facilitate segmenting higher resolution image data within the ROI.
Neither WAECHTER-STEHLE nor CLOUTIER explicitly teaches that the method is a computer-implemented method. However, WAECHTER-STEHLE does teach a processing system, (“image processor 68” see, e.g., [0042] and [0043]), and one skilled in the art would understand that the processing system carries out a computer-implemented method.
In the same field of endeavor, DAIGLE teaches a system architecture for implementing ultrasound processes. (Figure 9). DAIGLE’ teachings “can be implemented in a computing system that utilizes a software-based method and system architecture in accordance with one embodiment of the present disclosure. The system implements all real-time processing functions in software.” ([0072]; see also [0077]).
It would have been obvious to one having ordinary skill in the art to modify the method of WAECHTER-STEHLE as modified by CLOUTIER to be implemented as a computer-implemented method. One would be motivated to program a method that could be implemented by computers because computers can make a large number of computations, thereby simplifying and increasing accuracy of the process. Moreover, combining a known method with a conventional computer to automate steps of the method would yield predictable results. (MPEP 2143(A)).
With respect to claim 15, WAECHTER-STEHLE teaches a computer program product comprising computer program code means which, when executed on a computer device having a processing system, cause the processing system to perform all of the steps of the method according to claim 14. (see, e.g., [0094]-[0095], [0069], [0070], Figures 1, 9-12).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0060660 A1 (hereinafter “WAECHTER-STEHLE”) and U.S. Patent Appl. Publ. No. 2016/0287214 A1 (hereinafter “RALOVICH”) and U.S. Patent No. 7,925,064 B2 (hereinafter “CLOUTIER”) as applied to claim 10 above, and further in view of Papadacci et al. High-contrast ultrafast imaging of the heart. IEEE transactions on ultrasonics, ferroelectrics, and frequency control. 2014 Jan 27;61(2):288-301 (hereinafter “PAPADACCI”).
With respect to claim 12 (depending from claim 10), WAECHTER-STEHLE does not explicitly teach wherein a diverging transmit beam focal distance for each of the second plurality of transmit pulses is smaller than a focal distance for each of the first plurality of transmit pulses. However, WAECHTER-STEHLE may control the array to transmit a divergent ultrasound wave. ([0043]).
In the same field of endeavor, PAPADACCI teaches a method for “ultrafast imaging of the heart with adapted sector size by using diverging waves emitted from a classical transthoracic cardiac phased array probe.” (Abstract). In PAPADACCI, “ultrafast imaging was performed using diverging waves transmitted by a conventional phased-array probe over a large imaging sector. The method proposed here allows improvement of the contrast and resolution for an ultrafast acquisition at very high frame rate (more than 1000 images/s).” (p.11, IV. Discussion, first paragraph). A standard phased array probe was used for both the diverging beams and more conventional B-mode transmit. (p.8, III. Experiments). “The technique of coherent diverging waves compounding was implemented in real-time on an ultrafast scanner… The number of emitted diverging waves was varied from 1 to 20 diverging waves, providing a frame rate between 4600 and 250 frames/s, respectively. A sequence with conventional focusing in transmit (160 focused transmits at 60 mm) was also used for comparison.” (p.8, III. Experiments, first paragraph). Coherent compounding enables “a strong improvement of imaging quality…with a small number of transmitted diverging waves and a high frame rate.” (Abstract). “Diverging waves with small angular apertures would enable to regain the entire field of view of the image.” (p.12, last paragraph before Conclusion).
Accordingly, PAPADACCI teaches wherein a diverging transmit beam focal distance for each of the second plurality of transmit pulses is smaller than a focal distance for each of the first plurality of transmit pulse. To be clear, the focal distance of the first plurality of transmit pulses would have focused beams (i.e., like B-mode) which has a focal distance greater than the focal distance for diverging beams.
It would have been obvious to one skilled in the art to operate a phased array probe as taught in PAPADACCI that would enable a high resolution ROI with a low resolution extended field of view as taught in WAECHTER-STEHLE. WAECHTER-STEHLE teaches the desire to have a higher resolution ROI within a larger (lower resolution) volumetric region. PAPADACCI teaches one method for achieving this outcome. One would be motivated to use the diverging beam method taught in PAPADACCI because it provides an extended field of view while also permitting focused beams for the ROI. The PAPADACCI also enables higher frame rates. There would be a reasonable expectation of success as PAPADACCI teaches that diverging beams and focused beams can be achieved while using a conventional phased array probe.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0060660 A1 (hereinafter “WAECHTER-STEHLE”) and U.S. Patent Appl. Publ. No. 2016/0287214 A1 (hereinafter “RALOVICH”) and U.S. Patent No. 7,925,064 B2 (hereinafter “CLOUTIER”) as applied to claim 10 above, and further in view of Kremkau, Frederick W. “Temporal resolution.” Journal of Diagnostic Medical Sonography 7.6 (1991): 354-356 (hereinafter “KREMKAU”).
With respect to claim 13 (depending from claim 10), WAECHTER-STEHLE does not explicitly teach wherein a time interval between two consecutive transmit pulses of the second plurality of transmit pulses is greater than a time interval between two consecutive transmit pulses of the first plurality of transmit pulses. However, WAECHTER-STEHLE does discuss changing various parameters depending upon the circumstances. For example, WAECHTER-STEHLE teaches a scenario where adjusting the pulse repetition frequency (PRF) or pulse repetition interval (PRI) is necessary or desirable. For example, in one embodiment “[a]n embedded real time high frequency detail view 132′ image is generated simultaneous to a real time low frequency wide view 80 image. This has the advantage that the surrounding context is still imaged (albeit at lower resolution) in real time with relatively higher depth to allow for example orientation and navigation of tools that occur in the periphery of the ROI.” ([0079]; see also [0020]). WAECHTER-STEHLE also teaches “[i]t may be beneficial for the user to have reduced the density of the ultrasound beams steered outside of the ROI, thereby providing an increased frame rate of acquired ultrasound data from the volumetric region. This increase of the overall frame rate might result in the reduced resolution of the anatomy features located within the volumetric region but outside of the ROI.” ([0044]).
Notably, WAECHTER-STEHLE emphasizes how the system may be used in real-time. ([0079]). For ultrasound signals that penetrate deeper, the window of time for receiving echoes increases. In other words, the PRI increases.
KREMKAU is a “physics refresher” on “temporal resolution.” (Title) KREMKAU teaches that the processing system can be configured to control a time interval (i.e., pulse repetition interval or PRI) between two consecutive transmit pulses of the second plurality of transmit pulses (i.e., low resolution, wide field of view) is greater than a time interval between two consecutive transmit pulses of the first plurality of transmit pulses (i.e., ROI with high resolution, smaller field of view).
More specifically, KREMKAU teaches that “[e]ach scan line in a gray-scale image requires a pulse to be emitted by the transducer. The system must wait until all echoes have returned from one pulse before emitting the next one. Therefore, the pulse repetition frequency (PRF) must be lower for deeper imaging and can be higher for more superficial imaging.” (p.354, left column, bottom paragraph that extends into top paragraph in right column).
It would have been obvious to one having ordinary skill in the art to modify the WAECHTER-STEHLE system such that a time interval between two consecutive transmit pulses of the second plurality of transmit pulses is greater than a time interval between two consecutive transmit pulses of the first plurality of transmit pulse. As discussed above, there are various scenarios in which one skilled in the art would desire increasing the time interval for the second plurality of transmit pulses. To use one example, WAECHTER-STEHLE emphasizes real-time capabilities but also teaches having a greater penetration depth. As taught by KREMKAU, one well-known method for addressing this issue is to increase the time interval. (MPEP 2144.05, II: “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.”). There would be a reasonable expectation of success as KREMKAU teaches that the PRF can be changed. PRF is the inverse of PRI or the time interval.
RESPONSE TO APPLICANT’S ARGUMENTS:
Applicant alleges that WAECHTER-STEHLE is not prior art under 35 U.S.C. 102(b)(2)(C) and, as such, the Section 103 rejection should be withdrawn. However, this exception applies to 102(a)(2) prior art. WAECHTER-STEHLE qualifies as prior art under 102(a)(1).
While there are exceptions to 102(a)(1) prior art, none are applicable here. WAECHTER-STEHLE was published on February 27, 2020. The earliest effective filing date of the pending application is September 30, 2021. WAECHTER-STEHLE was published more than one year before the earliest effective filing date. As such, WAECHTER-STEHLE is available as prior art under Section 102(a)(1). (See MPEP 717.02(b), II: “The 35 U.S.C. 102(b)(2)(C) exception does not apply to a disclosure that qualifies as prior art under 35 U.S.C. 102(a)(1) (disclosures publicly made before the effective filing date of the claimed invention). In other words, the prior art exception under 35 U.S.C. 102(b)(2)(C) only disqualifies the disclosure as prior art under 35 U.S.C. 102(a)(2).”).
Applicant did not provide any additional arguments with respect to the Section 103 rejection of claim 1 nor any arguments with respect to any other claims.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-20160262720-A1 teaches an ultrasound system configured to enhance the imaging of a sub-volume. “An entire volume is scanned. A sub-volume is separately scanned with different settings for beamforming parameters, allowing greater image quality for the sub-volume while providing context from the volume.” (Abstract).
Conclusion
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/JASON P GROSS/Examiner, Art Unit 3797 /SERKAN AKAR/Primary Examiner, Art Unit 3797
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