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 .
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, and 6-15 are rejected under 35 U.S.C. 103 as being unpatentable over Veronesi et al (US20220317294A1; hereinafter referred to as Veronesi) in view of Matsumara et al (US20240024037A1; hereinafter referred to as Matsumara)
Regarding Claim 1, Veronesi discloses an ultrasound imaging system comprising a console configured to be operably associated with an imaging device, wherein the console comprises a hardware processor coupled to non- transitory, computer-readable memory containing instructions executable by the processor ("An ultrasound imaging system includes a probe for obtaining a 3D image dataset on a structure to be imaged, a processor operably connected to the probe and configured to generate a 3D volume and at least one 2D image from the 3D image dataset and a display operably connected to the processor to present the 3D volume and the at least one 2D image on the display, wherein the processor is configured to register a 3D anatomical model to the 3D volume and to display the 3D anatomical model in alignment with the at least one 2D image.” [0009]) to cause the console to:
receive three-dimensional (3D) image data from an ultrasound imaging device ("the ultrasound imaging system 100 is operated to image an anatomical structure 200 of a patient, such as the heart 202 when obtained in an echocardiographic procedure, the probe 106 obtains a 3D image dataset that is transmitted to the processor 116 for image generation." [0030]);
and dynamically reconstruct multiple images from the 3D image data, the multiple images comprising at least one 3D image providing a 3D view of an anatomical region of interest and one or more separate corresponding two-dimensional (2D) images providing 2D views of the anatomical region of interest and spatially related to the 3D view, wherein the one or more corresponding 2d images is digitally reconstructed from a selected portion of the region of interest depicted in the 3D view ("In doing so, the processor 116 creates a reconstructed 3D volume/image or rendering 204 of the structure 200. In addition, using the process of multi-planar reconstruction (MPR), the processor 116 generates one or more 2D planar views 206 of predetermined and/or selected slices though the 3D volume/image 204. The 2D planar images 206 are presented on the display 118 in conjunction with the 3D volume/image 204," [0030]).
and augment at least the 3D view with one or more annotations so as to highlight a specific portion of the anatomical region of interest reconstructed in the 2D view to thereby provide a visual indication of a spatial relationship between the 3D image and the 2D image (“if a particular anatomical feature 224 of the structure 200 is desired to be highlighted in the images 204,206 (e.g., left atrial appendage, mitral valve center, right ventricle, etc.), that feature 224 can be selected in the model 208. Because the 3D anatomical model 208 is registered to the 3D volume/image 204 and the 2D planar images 206, the area 226 of the image 204,206 corresponding to the selected feature 224 of the model 208 can be highlighted, such as by providing an outline 228 in the image 204,206 representing the location of the selected feature 224 and the alignment of the feature 224. Alternatively, or in combination with an outline 228, the labeling can be performed using color coding (not shown), e.g., illustrating the left ventricle in red, right ventricle in blue, etc. within the 3D model 208 and/or as readable text (not shown) located within the associated 2D planar images 206.” [0041]).
Veronesi does not specifically disclose that the one or more corresponding 2D images provides one or more of a reconstructed phased array visualization and a reconstructed circumferential radial visualization of the anatomical region of interest.
However, in a similar field of endeavor, Matsumara teaches Systems and methods for providing image guidance during interventional medical procedures are disclosed [Abstract].
Matsumara also teaches that the one or more corresponding 2D images provides one or more of a reconstructed phased array visualization and a reconstructed circumferential radial visualization of the anatomical region of interest ("A variety of transducer arrays may be used, e.g., linear arrays, curved arrays, or phased arrays. The transducer array 114, for example, can include a two dimensional array (as shown) of transducer elements capable of scanning in both elevation and azimuth dimensions for 2D and/or 3D imaging." [0030], “the signals produced by the signal processor 134 may be coupled to a scan converter 142 and/or a multiplanar reformatter 144. The scan converter 142 may be configured to arrange the echo signals into the intended geometric format. For instance, data collected by a linear array transducer would represent a rectangle or a trapezoid, whereas the same for a sector probe would represent a sector of a circle.” [0041]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Veronesi as outlined above with the one or more corresponding 2D images provides one or more of a reconstructed phased array visualization and a reconstructed circumferential radial visualization of the anatomical region of interest as taught by Matsumara, because new ultrasound systems configured to improve the accuracy and consistency of interventional procedures in a computationally efficient manner are needed [0002].
Regarding Claim 2, Veronesi discloses that each of the multiple images comprises at least one of a slice- based image and a volume-based image ("the image data/dataset is a three dimensional (3D) image dataset that can be rendered into a 3D volume that is utilized to generate images of multiple planes of the imaged structure that are presented to the user of the ultrasound imaging system. The process for producing these planar images involves multi-planar reconstruction (MPR) and allows effective display of 3D image dataset by providing multiple planes, which are typically three (3) orthogonal 2D planes, in association with the 3D volume. The 3D volume 1000 is sliced at different locations and with different orientation to form the 2D planar views or images 1002 that are presented with the 3D volume 1000 in the MPR display 1004, as shown in FIG. 1." [0003]).
Regarding Claim 6, Veronesi discloses all limitations noted above except that the one or more 2D images provide multiple phased array views of the anatomical region of interest.
However, in a similar field of endeavor, Matsumara teaches that the one or more 2D images provide multiple phased array views of the anatomical region of interest ("A variety of transducer arrays may be used, e.g., linear arrays, curved arrays, or phased arrays. The transducer array 114, for example, can include a two dimensional array (as shown) of transducer elements capable of scanning in both elevation and azimuth dimensions for 2D and/or 3D imaging." [0030], “the signals produced by the signal processor 134 may be coupled to a scan converter 142 and/or a multiplanar reformatter 144. The scan converter 142 may be configured to arrange the echo signals into the intended geometric format. For instance, data collected by a linear array transducer would represent a rectangle or a trapezoid, whereas the same for a sector probe would represent a sector of a circle.” [0041]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Veronesi as outlined above with the one or more 2D images provide multiple phased array views of the anatomical region of interest as taught by Matsumara, because new ultrasound systems configured to improve the accuracy and consistency of interventional procedures in a computationally efficient manner are needed [0002].
Regarding Claim 7, Veronesi discloses that each of the multiple images comprises one or more annotations providing a visual indication of a spatial relationship of one of the multiple images relative to another one of the multiple images (“if a particular anatomical feature 224 of the structure 200 is desired to be highlighted in the images 204,206 (e.g., left atrial appendage, mitral valve center, right ventricle, etc.), that feature 224 can be selected in the model 208. Because the 3D anatomical model 208 is registered to the 3D volume/image 204 and the 2D planar images 206, the area 226 of the image 204,206 corresponding to the selected feature 224 of the model 208 can be highlighted, such as by providing an outline 228 in the image 204,206 representing the location of the selected feature 224 and the alignment of the feature 224. Alternatively, or in combination with an outline 228, the labeling can be performed using color coding (not shown), e.g., illustrating the left ventricle in red, right ventricle in blue, etc. within the 3D model 208 and/or as readable text (not shown) located within the associated 2D planar images 206.” [0041]).
Regarding Claim 8, Veronesi discloses that the multiple images comprise a 3D image and two or more 2D images spatially related to the 3D image ("In doing so, the processor 116 creates a reconstructed 3D volume/image or rendering 204 of the structure 200. In addition, using the process of multi-planar reconstruction (MPR), the processor 116 generates one or more 2D planar views 206 of predetermined and/or selected slices though the 3D volume/image 204. The 2D planar images 206 are presented on the display 118 in conjunction with the 3D volume/image 204," [0030]).
Regarding Claim 9, Veronesi discloses that the 3D image comprises annotations separately associated with each of the two or more 2D images, wherein each annotation provides a visual indication of a position of the anatomical region of interest from within the 3D view that is associated with a 2D view of a respective 2D image (“if a particular anatomical feature 224 of the structure 200 is desired to be highlighted in the images 204,206 (e.g., left atrial appendage, mitral valve center, right ventricle, etc.), that feature 224 can be selected in the model 208. Because the 3D anatomical model 208 is registered to the 3D volume/image 204 and the 2D planar images 206, the area 226 of the image 204,206 corresponding to the selected feature 224 of the model 208 can be highlighted, such as by providing an outline 228 in the image 204,206 representing the location of the selected feature 224 and the alignment of the feature 224. Alternatively, or in combination with an outline 228, the labeling can be performed using color coding (not shown), e.g., illustrating the left ventricle in red, right ventricle in blue, etc. within the 3D model 208 and/or as readable text (not shown) located within the associated 2D planar images 206.” [0041]).
Regarding Claim 10, Veronesi discloses that each of the 2D images comprises an annotation associated with one another (“if a particular anatomical feature 224 of the structure 200 is desired to be highlighted in the images 204,206 (e.g., left atrial appendage, mitral valve center, right ventricle, etc.), that feature 224 can be selected in the model 208. Because the 3D anatomical model 208 is registered to the 3D volume/image 204 and the 2D planar images 206, the area 226 of the image 204,206 corresponding to the selected feature 224 of the model 208 can be highlighted, such as by providing an outline 228 in the image 204,206 representing the location of the selected feature 224 and the alignment of the feature 224. Alternatively, or in combination with an outline 228, the labeling can be performed using color coding (not shown), e.g., illustrating the left ventricle in red, right ventricle in blue, etc. within the 3D model 208 and/or as readable text (not shown) located within the associated 2D planar images 206.” [0041]).
Regarding Claim 11, Veronesi discloses that an annotation in a first one of the 2D images provides a visual indication of a position of the anatomical region of interest from within the 2D view of the first one of the 2D images that is associated with the 2D view of a second one of the 2D images (“if a particular anatomical feature 224 of the structure 200 is desired to be highlighted in the images 204,206 (e.g., left atrial appendage, mitral valve center, right ventricle, etc.), that feature 224 can be selected in the model 208. Because the 3D anatomical model 208 is registered to the 3D volume/image 204 and the 2D planar images 206, the area 226 of the image 204,206 corresponding to the selected feature 224 of the model 208 can be highlighted, such as by providing an outline 228 in the image 204,206 representing the location of the selected feature 224 and the alignment of the feature 224. Alternatively, or in combination with an outline 228, the labeling can be performed using color coding (not shown), e.g., illustrating the left ventricle in red, right ventricle in blue, etc. within the 3D model 208 and/or as readable text (not shown) located within the associated 2D planar images 206.” [0041]).
Regarding Claim 12, Veronesi discloses that an annotation in a second one of the 2D images provides a visual indication of a position of the anatomical region of interest from within the 2D view of the second one of the 2D images that is associated with the 2D view of the first one of the 2D images (“if a particular anatomical feature 224 of the structure 200 is desired to be highlighted in the images 204,206 (e.g., left atrial appendage, mitral valve center, right ventricle, etc.), that feature 224 can be selected in the model 208. Because the 3D anatomical model 208 is registered to the 3D volume/image 204 and the 2D planar images 206, the area 226 of the image 204,206 corresponding to the selected feature 224 of the model 208 can be highlighted, such as by providing an outline 228 in the image 204,206 representing the location of the selected feature 224 and the alignment of the feature 224. Alternatively, or in combination with an outline 228, the labeling can be performed using color coding (not shown), e.g., illustrating the left ventricle in red, right ventricle in blue, etc. within the 3D model 208 and/or as readable text (not shown) located within the associated 2D planar images 206.” [0041]).
Regarding Claim 13, Veronesi discloses that the one or more annotations comprises a highlighted marking, wherein the highlighted marking comprises a shade or color having a contrasting appearance relative to surrounding portion of a respective image upon which the annotation is applied (“if a particular anatomical feature 224 of the structure 200 is desired to be highlighted in the images 204,206 (e.g., left atrial appendage, mitral valve center, right ventricle, etc.), that feature 224 can be selected in the model 208. Because the 3D anatomical model 208 is registered to the 3D volume/image 204 and the 2D planar images 206, the area 226 of the image 204,206 corresponding to the selected feature 224 of the model 208 can be highlighted, such as by providing an outline 228 in the image 204,206 representing the location of the selected feature 224 and the alignment of the feature 224. Alternatively, or in combination with an outline 228, the labeling can be performed using color coding (not shown), e.g., illustrating the left ventricle in red, right ventricle in blue, etc. within the 3D model 208 and/or as readable text (not shown) located within the associated 2D planar images 206.” [0041]).
Regarding Claim 14, Veronesi discloses that the console is configured to augment the multiple images with the one or more annotations based, at least in part, on user input with the system (“if a particular anatomical feature 224 of the structure 200 is desired to be highlighted in the images 204,206 (e.g., left atrial appendage, mitral valve center, right ventricle, etc.), that feature 224 can be selected in the model 208. Because the 3D anatomical model 208 is registered to the 3D volume/image 204 and the 2D planar images 206, the area 226 of the image 204,206 corresponding to the selected feature 224 of the model 208 can be highlighted, such as by providing an outline 228 in the image 204,206 representing the location of the selected feature 224 and the alignment of the feature 224. Alternatively, or in combination with an outline 228, the labeling can be performed using color coding (not shown), e.g., illustrating the left ventricle in red, right ventricle in blue, etc. within the 3D model 208 and/or as readable text (not shown) located within the associated 2D planar images 206.” [0041]).
Regarding Claim 15, Veronesi discloses that the console is configured to receive the full circumferential, 3D image data in real-time or near real-time and the console is configured to reconstruct the multiple images in real-time or near real-time, based, at least in part, on one or more of user input and predefined protocols ("The processor 116 is adapted to perform one or more processing operations according to a plurality of selectable ultrasound modalities on the data. The data may be processed in real-time during a scanning session as the echo signals are received. " [0026]).
Claims 3, & 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Veronesi in view of Matsumara as applied to Claim 1 above, and further in view of Hennersperger et al (US20210085287A1; hereinafter referred to as Hennersperger)
Regarding Claim 3, Veronesi in view of Matsumara teaches all limitations noted above except that the at least one 3D image provides a full circumferential, 360- degree visualization of the anatomical region of interest.
However, in a similar field of endeavor, Hennersperger teaches systems and methods for visualization and characterization of human tissue using three-dimensional ultrasound monitoring.
Hennersperger teaches that the at least one 3D image provides a full circumferential, 360- degree visualization of the anatomical region of interest ("The disclosed system is able to acquire a 360-degree volumetric image of the vasculature and surrounding tissue or a subsection thereof." [0080]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Veronesi in view of Matsumara as outlined above with at least one 3D image provides a full circumferential, 360- degree visualization of the anatomical region of interest as taught by Hennersperger, because it is capable of determining accurate depth and contiguity/permanency monitoring of ablations [0030].
Regarding Claim 16, Veronesi in view of Matsumara discloses all limitations noted above except that the ultrasound imaging device comprises a catheter-based ultrasound imaging device comprising a catheter including a rotatable ultrasound transducer array provided thereon configured to transmit ultrasound pulses to, and receive echoes of the ultrasound pulses from, one or more of intravascular and intracardiac tissue, wherein the image data is in the form of reflected signal data based on received echoes of the ultrasound pulses from the one or more of intravascular and intracardiac tissue.
However, in a similar field of endeavor, Hennersperger teaches that the ultrasound imaging device comprises a catheter-based ultrasound imaging device comprising a catheter including a rotatable ultrasound transducer array provided thereon configured to transmit ultrasound pulses to, and receive echoes of the ultrasound pulses from, one or more of intravascular and intracardiac tissue, wherein the image data is in the form of reflected signal data based on received echoes of the ultrasound pulses from the one or more of intravascular and intracardiac tissue ("A method for ultrasound imaging using an imaging system including (i) a catheter comprising a proximal end and a distal end, the distal end of the catheter comprising a catheter tip, the catheter tip comprising an ultrasound transducer array enclosed within an acoustic housing and extending along a longitudinal axis of the catheter, wherein the distal end of the catheter is configured to be inserted into and guided to a site of a procedure in a medium, and wherein the ultrasound transducer array is rotatable within the acoustic housing while transmitting ultrasound pulses and receiving ultrasound echoes from the surrounding medium" [0026], "catheter-based ultrasound imaging system (UIS) that provides a full circumferential 360-degree view around an intra-vascular/intra-cardiac imaging-catheter-head" [0062]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Veronesi in view of Matsumara as outlined above with the ultrasound imaging device comprises a catheter-based ultrasound imaging device comprising a catheter including a rotatable ultrasound transducer array provided thereon configured to transmit ultrasound pulses to, and receive echoes of the ultrasound pulses from, one or more of intravascular and intracardiac tissue, wherein the image data is in the form of reflected signal data based on received echoes of the ultrasound pulses from the one or more of intravascular and intracardiac tissue as taught by Hennersperger, because it is capable of determining accurate depth and contiguity/permanency monitoring of ablations [0030].
Regarding Claim 17, Veronesi in view of Matsumara discloses all limitations noted above except that the console is further configured to:process the reflected signal data using at least one of a functional imaging algorithm and an anatomical imaging algorithm to extract associated functional and anatomical parameter data of the anatomical region of interest and reconstruct the multiple images from the extracted functional and anatomical parameter data; and output, via a display, the reconstructed multiple images to an operator depicting visualization of the anatomical region of interest
However, in a similar field of endeavor, Hennersperger teaches that the console is further configured to:process the reflected signal data using at least one of a functional imaging algorithm and an anatomical imaging algorithm to extract associated functional and anatomical parameter data of the anatomical region of interest and reconstruct the multiple images from the extracted functional and anatomical parameter data; and output, via a display, the reconstructed multiple images to an operator depicting visualization of the anatomical region of interest ("The disclosed imaging protocols and algorithms are used to reconstruct the functional tissue parameters of an organ of interest." [0074], "The imaging protocols and algorithms can generate a two-dimensional image of a selected region, a sub-volumetric three-dimensional image or a full three-dimensional volumetric image around the catheter." [0075], "The tissue state mapping or functional imaging is performed by integration of the tissue data with the appropriate imaging protocols and reconstruction algorithms, as described above. These individual protocols and algorithms are integrated to evaluate and extract information from the data on, for example, stiffness, micro-vasculature, elasticity, perfusion, flow, shear wave speed, and other information that indicates the tissue state." [0080], "The display work station also includes the display module and graphical user interface (GUI) 408E needed for generating two and three dimensional display and providing an interactive display manipulation capability to the user interacting with the display of the result." [0089]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Veronesi in view of Matsumara as outlined above with the console is further configured to:process the reflected signal data using at least one of a functional imaging algorithm and an anatomical imaging algorithm to extract associated functional and anatomical parameter data of the anatomical region of interest and reconstruct the multiple images from the extracted functional and anatomical parameter data; and output, via a display, the reconstructed multiple images to an operator depicting visualization of the anatomical region of interest as taught by Hennersperger, because it is capable of determining accurate depth and contiguity/permanency monitoring of ablations [0030].
Regarding Claim 18, Veronesi in view of Matsumara discloses all limitations noted above except that the functional parameter data comprises at least one of tissue perfusion, tissue motion, tissue stiffness or elasticity, tissue strain, tissue anisotropy, tissue coherence, specific statistic tissue parameters modeled by statistical distributions, textural parameters of the tissue, and spectral and frequency-based parameters of the tissue, and blood flow, wherein the functional parameter data is indicative of a characterization of tissue at the anatomical region of interest and the anatomical parameter data comprises at least one of spatial and geometrical relationship of tissue at the anatomical region of interest, and the tissue characterization comprises at least one of tissue type, tissue health, tissue depth, lesion formation in the tissue as a result of an ablation procedure, and lesion depth in the tissue.
However, in a similar field of endeavor, Hennersperger teaches that the functional parameter data comprises at least one of tissue perfusion, tissue motion, tissue stiffness or elasticity, tissue strain, tissue anisotropy, tissue coherence, specific statistic tissue parameters modeled by statistical distributions, textural parameters of the tissue, and spectral and frequency-based parameters of the tissue, and blood flow, wherein the functional parameter data is indicative of a characterization of tissue at the anatomical region of interest and the anatomical parameter data comprises at least one of spatial and geometrical relationship of tissue at the anatomical region of interest, and the tissue characterization comprises at least one of tissue type, tissue health, tissue depth, lesion formation in the tissue as a result of an ablation procedure, and lesion depth in the tissue ("The tissue state mapping or functional imaging is performed by integration of the tissue data with the appropriate imaging protocols and reconstruction algorithms, as described above. These individual protocols and algorithms are integrated to evaluate and extract information from the data on, for example, stiffness, micro-vasculature, elasticity, perfusion, flow, shear wave speed, and other information that indicates the tissue state." [0080] " both anatomical and functional imaging of tissue can be retrieved in real-time from the target anatomy." [0063], " Anatomical imaging may relate to specific data generated by imaging protocols and processing methods that primarily aim at depicting the spatial/geometrical relationship of tissue." [0065], "imaging catheters may be utilized for lesion map reconstruction by imaging an area before and after a procedure, comparing the results and identifying differences." [0147]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Veronesi in view of Matsumara as outlined above with the functional parameter data comprises at least one of tissue perfusion, tissue motion, tissue stiffness or elasticity, tissue strain, tissue anisotropy, tissue coherence, specific statistic tissue parameters modeled by statistical distributions, textural parameters of the tissue, and spectral and frequency-based parameters of the tissue, and blood flow, wherein the functional parameter data is indicative of a characterization of tissue at the anatomical region of interest and the anatomical parameter data comprises at least one of spatial and geometrical relationship of tissue at the anatomical region of interest, and the tissue characterization comprises at least one of tissue type, tissue health, tissue depth, lesion formation in the tissue as a result of an ablation procedure, and lesion depth in the tissue as taught by Hennersperger, because it is capable of determining accurate depth and contiguity/permanency monitoring of ablations [0030].
Regarding Claim 19, Veronesi discloses that the console is configured to output, via the display, the reconstructed multiple images in response to user input with a user interface operably associated with the console ("A user interface 115 may be used to control operation of the ultrasound imaging system 100, including controlling the input of patient data, changing a scanning or display parameter, and the like. The user interface 115 may include a graphical user interface configured for display on a display device 118. " [0024]).
Regarding Claim 20, Veronesi discloses that the console is configured to output, via the display, the reconstructed multiple images based, at least in part, on running an algorithm determining one or more suggested views to displayed to the user based on the anatomical region of interest (“In addition, using the process of multi-planar reconstruction (MPR), the processor 116 generates one or more 2D planar views 206 of predetermined and/or selected slices though the 3D volume/image 204. The 2D planar images 206 are presented on the display 118 in conjunction with the 3D volume/image 204, which in the exemplary embodiment of FIG. 3 shows three (3) 2D planar views 206 in association with the 3D volume/image 204, each disposed in separated windows or frames 218 of the display 118 and identified to indicate the particular view represented by the 2D planar view 206 being displayed, which can be standardized views and/or user-selected views, or combinations thereof.” [0030]).
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
Regarding the U.S.C. 103 rejection of claim 1 the applicant argues the following:
The Office Action points to a two-sentence disclosure in paragraph [0030] and a two-sentence disclosure in paragraph [0041] of the entire disclosure of Matsumara to conclude that Matsumara teaches the 2D images are one or more a reconstructed phased array visualization and a reconstructed circumferential radial visualization of the anatomical region of interest. Office Action, page 5. Accordingly, the Office Action states that "[i]t would have been obvious to an ordinary skilled person in the art before the effective filing date of the claimed invention to modify the system of Veronesi. . .with the one or more corresponding 2D images ... of a reconstructed phased array visualization and a reconstructed circumferential radial visualization of the anatomical region of interest as taught by Matsumara, because new ultrasound systems configured to improve the accuracy and consistency of interventional procedures in a computationally efficient manner are needed" (citing Matsumara, [0002].
Applicant disagrees. Such a conclusory finding indicates either that: (1) the Office is using improper hindsight reasoning based on the Applicant's disclosure, (2) the Office has taken official notice of an undisputed fact without citing the appropriate documentary evidence; or (3) the Office has not performed or provided the required articulated rationale under 35 USC § 103 to provide a primafacie case of obviousness.
Applicant submits that nowhere in its disclosure does Matsumara teach or suggest digital reconstruction of 2D images in one or more a reconstructed phased array visualization and a reconstructed circumferential radial visualization of the anatomical region of interest, as recited in amended claim 1.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
It is first noted, that under the broadest reasonable interpretation of Claim 1 all that is required a system which 1) reconstructs a 3D image from an ultrasound transducer data set, 2) reconstructs 2D images from the 3D image set at desired regions of interest, and 3) the 2D images comprise a phased array visualization or a circumferential radial visualization
Veronesi teaches 1) reconstructing a 3D image from an ultrasound transducer data set and 2) reconstructs 2D images from the 3D image set at desired regions of interest ("the ultrasound imaging system 100 is operated to image an anatomical structure 200 of a patient, such as the heart 202 when obtained in an echocardiographic procedure, the probe 106 obtains a 3D image dataset that is transmitted to the processor 116 for image generation… In doing so, the processor 116 creates a reconstructed 3D volume/image or rendering 204 of the structure 200. In addition, using the process of multi-planar reconstruction (MPR), the processor 116 generates one or more 2D planar views 206 of predetermined and/or selected slices though the 3D volume/image 204. The 2D planar images 206 are presented on the display 118 in conjunction with the 3D volume/image 204," [0030]).
It is also noted that Veronesi specifically discloses that any transducer with any geometry could be used in the system (“The ultrasound imaging system 100 includes a transmit beamformer 101 and a transmitter 102 that drive transducer elements 104 within a probe 106 to emit pulsed ultrasonic signals into a body (not shown). A variety of geometries of probes and transducer elements may be used.” [0023])
Matsumura teaches a system for reconstructing 2D/3D ultrasound images by acquiring volumetric image data of a region of interest, and automatically reconstructing specific views of one or more regions of interest based on the identified anatomical landmarks. The reconstructed views can then be used to guide a clinician performing an interventional medical procedure [0003-0004].
Matsumura also teaches using both phased array transducers and sector (radial) probes which inherently acquire their respective volumetric data in phased array geometries and radial geometries (“A variety of transducer arrays may be used, e.g., linear arrays, curved arrays, or phased arrays.” [0030], “For instance, data collected by a linear array transducer would represent a rectangle or a trapezoid, whereas the same for a sector probe would represent a sector of a circle.” [0041]).
When combined, Veronesi and Matsumara teach a clear progression of using a phased array or sector probe which acquires volumetric data with its respective phased or radial geometry. The acquired volumetric data is then reconstructed into a 3D image which would inherently have to maintain the same geometry and visualization as the acquired volumetric data. Finally, the 2D image is reconstructed at specifically desired points from the 3D image data set and would also once again inherently require the same geometry and visualization.
The combination would be proper since both inventions are 1) in the same field of endeavor dealing with multiplanar reconstructed cardiac ultrasound images, and 2) does not unintuitively combine the inventions (Veronesi specifically mentions the capability for multiple different types of probe and transducer geometries)
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN MALDONADO whose telephone number is 703-756-1421. The examiner can normally be reached 8:00 am-4:00 pm PST M-Th 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
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/Steven Maldonado/
Patent Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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