DETAILED ACTION
This office action is responsive to original claims filed on 02/10/2026. Presently, Claims 1 - 18 remain pending.
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 § 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 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
With regard to Claims 1-16 and 18:
Step 1: the claims are drawn to an apparatus/non-transitory computer readable medium, one of the four statutory categories.
Step 2A, Prong One:
The claims recite the limitations of “divide … an ultrasonic image into … regions”, “determine whether … is a vascular region”, “normalize statistical information …”, “synthesize …” in Claims 1, 16 and 18, “synthesizing …” and “generate statistical information …” in Claim 2, “generate … a statistical graph …” in Claim 3, “calculates …” in Claim 4, “calculates … a spectrum …” in Claim 5, “calculates … by Fourier analysis …” in Claim 6, “calculates … a Doppler spectrum …” in Claim 7, “normalizes the Doppler spectrum based on …” in Claim 8, “performs angular correction …” in Claim 9, “estimates the main direction of blood flow … ” in Claim 10, “performing threshold processing …” in Claim 11, “generates a plurality of pieces of … averaging the pieces of …” in Claim 12, “acquire a vascular region by morphology analysis”, “normalize statistical information …”, and “synthesize …” in Claim 14, “performs … normalization …” and “synthesizes the Doppler spectrum …” in Claim 15. The recited limitations are, under their broadest reasonable interpretation, limitations that cover performance of the limitations in the mind or by mathematical calculations. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or by mathematical calculations but for the recitation of generic computer and imaging components, then it falls within the “Mental Processes” or “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements – processing circuitry, displaying on a display, generating a blood flow image, and a computer. The recited generating blood flow image, its processing using processing circuitry, and displaying on a display are recited at a high-level of generality (i.e., as a generic procedure of acquiring, processing and displaying Doppler ultrasound images) such that it amounts no more than mere instructions to apply the exception using generic ultrasound and computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of acquiring, processing and displaying ultrasonic images amount to no more than mere instructions to apply the exception using generic ultrasound and computer components. Mere instructions to apply an exception using generic ultrasound and computer components cannot provide an inventive concept.
For the reasons set forth above, Claims 1-16 and 18 are not patent eligible.
With regard to Claim 17:
Step 1: the claim is drawn to a method, one of the four statutory categories.
Step 2A, Prong One:
The claim recites the limitations of “dividing … an ultrasonic image into … regions”, “determining whether … is a vascular region”, “normalizing statistical information …”, “synthesizing …”, which are, under their broadest reasonable interpretation, limitations that cover performance of the limitation in the mind or by mathematical calculations. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or mathematical calculations but for the recitation of generic computer components, then it falls within the “Mental Processes” or “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A, Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claim recites additional element of computer, which is recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer. Accordingly, the additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a computer amounts to no more than mere instructions to apply the exception using a generic computer. Mere instructions to apply an exception using a generic computer cannot provide an inventive concept.
For the reasons set forth above, Claim 17 is not patent eligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 7, 11, 13-14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Xie et al (US 20210145399 A1; hereafter Xie), in view of Alizad et al (US 12175662 B2; hereafter Alizad).
With regard to Claim 1, Xie discloses an ultrasonic diagnostic apparatus (Xie, Para 0030; “A system 100 for visualization and quantification of ultrasound imaging data according to embodiments of the present disclosure … a processor 120 …”) comprising processing circuitry (processor 120, as shown in Fig. 1) configured to:
divide at least a part of an ultrasonic image into a plurality of regions (Xie, Para 0033; “… the processor 120 may be configured to receive a selection of a region of interest (ROI) within the flow region …”. The disclosed selection of ROI corresponds to the claimed dividing an image into regions);
normalize statistical information about blood flow in a region determined to be a vascular region (Xie, Para 0043; “… the minimum and maximum velocity (e.g., yellow for the minimum velocity magnitude of 0 cm/s and red for the maximum velocity, in this case 60 cm/s) …” As shown in Fig. 6C, the velocity magnitude is normalized in a range of [0, 60] cm/s, and flow direction in range of [-180, +180] degrees); and
synthesize the normalized statistical information (Xie, Para 0065; “The system may identify one or more regions … based on the statistical analysis and may designate the subset of pixels associated with … as the ROI. … continue by generating and displaying graphical representations of quantitative information about the flow within the selected ROI.” The disclosed selected ROI combines a subset of pixels and possibly multiple separate regions, and after merging into one ROI, the quantitative information about the flow in the pixels or regions is combined or synthesized).
Xie does not clearly and explicitly disclose determining whether a region is a vascular region.
Alizad in the same field of endeavor discloses determining whether a region is a vascular region (Alizad, Column 7, Lines 4-5; “In step 202, the microvessel image can be converted to a binary image by setting an intensity threshold. The output binary image, IB(x, z), replaces all pixel values in the input image with luminance greater than a selected threshold with values of 1, and replaces all other pixel values with values of 0”; Column 2, Lines 2-5; “… the binary image contains pixels with first binary values and pixels with second binary values, wherein pixels with the first binary value correspond to segmented vessel.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xie, as suggested by Alizad, in order to determine if a region to be analyzed is vascular. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improving efficiency by focusing on analyzing vascular region only.
With regard to Claim 2, Xie and Alizad disclose the ultrasonic diagnostic apparatus according to Claim 1. Xie further discloses wherein the processing circuitry
generates synthetic statistical information indicating a statistical distribution of vessel count with respect to blood flow velocity (histograms of the flow direction, velocity magnitude, combinations of the two) by synthesizing the normalized statistical information (Xie, Para 0065; “The system may identify one or more regions … based on the statistical analysis and may designate the subset of pixels associated with … as the ROI. … continue by generating and displaying graphical representations of quantitative information about the flow within the selected ROI. For example, histograms of the flow direction, velocity magnitude, combinations of the two, or statistical measures of variability or combinations of the statistical measures with the velocity parameters, may be displayed in either 2D or 3D fashion, as shown in block 918”. By identifying and combining more than one regions as disclosed, quantitative information about the flow within an ROI is synthesized),
generates statistical information for display about blood flow velocity from the synthetic statistical information (Xie, Para 0065; “… histograms of the flow direction, velocity magnitude, combinations of the two, or statistical measures of variability or combinations of the statistical measures with the velocity parameters …”. All the disclosed histograms and statistical measures are about blood flow velocity and for display), and
displays the statistical information for display on a display (Xie, Para 0065; “… histograms of the flow direction, velocity magnitude, combinations of the two, or statistical measures of variability or combinations of the statistical measures with the velocity parameters, may be displayed in either 2D or 3D fashion, as shown in block 918”; Para 0033; “… the display unit 110 to display additional quantitative information 112-2 about the ROI, such as one or more histograms.”).
With regard to Claim 3, Xie and Alizad disclose the ultrasonic diagnostic apparatus according to Claim 2. Xie further discloses wherein the processing circuitry
generates, as the statistical information for display, a statistical graph indicating a statistical distribution of vessel count with respect to blood flow velocity (histograms of the flow direction, velocity magnitude, combinations of the two), and
displays the statistical graph on the display (Xie, Para 0065; “… histograms of the flow direction, velocity magnitude, combinations of the two, or statistical measures of variability or combinations of the statistical measures with the velocity parameters, may be displayed in either 2D or 3D fashion, as shown in block 918”; Para 0033; “… the display unit 110 to display additional quantitative information 112-2 about the ROI, such as one or more histograms.”. The disclosed histograms correspond to the claimed statistical graph).
With regard to Claim 4, Xie and Alizad disclose the ultrasonic diagnostic apparatus according to Claim 2. Xie further discloses wherein the processing circuitry
calculates, as the statistical information for display, at least one of average flow velocity, standard deviation, mode, median, variance, and third-order or higher moment of blood flow velocities of a plurality of vessels, and
displays the calculated at least one of average flow velocity, standard deviation, mode, median, variance, and third-order or higher moment of blood flow velocities of the vessels on the display (Xie, Para 0033; “… the system 100 may display the flow distribution in the format of a histogram of flow direction and/or speed accompanied by statistical analysis (e.g., mean, standard deviation, and/or higher order statistics).”).
With regard to Claim 7, Xie and Alizad disclose the ultrasonic diagnostic apparatus according to Claim 1. Xie further discloses wherein the processing circuitry calculates, as the statistical information, a Doppler spectrum of the region determined to be a vascular region (Xie, Para 0061; “… the Doppler processor 842 may include a Doppler estimator such as an auto-correlator, in which velocity (Doppler frequency) estimation is based on the argument of the lag-one autocorrelation function and Doppler power estimation is based on the magnitude of the lag-zero autocorrelation function.” The disclosed Doppler frequency corresponds to the claimed Doppler spectrum).
With regard to Claim 11, Xie and Alizad disclose the ultrasonic diagnostic apparatus according to Claim 1, but as discussed above do not explicitly and clearly disclose wherein the processing circuitry determines whether each of the regions is the vascular region by performing threshold processing pixel by pixel on a spatial distribution based on each of the regions.
Alizad further discloses determining whether a region is the vascular region by performing threshold processing pixel by pixel on a spatial distribution based on the region (Alizad, Column 7, Lines 4-9; “the microvessel image can be converted to a binary image by setting an intensity threshold. The output binary image, IB (x, z), replaces all pixel values in the input image with luminance greater than a selected threshold with values of 1, and replaces all other pixel values with values of 0.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xie and Alizad, as further suggested by Alizad, in order to use pixel-wise thresholding to determine vascular region. One of ordinary skill in the art would have been motivated to make the modification for the benefit of thresholding method being one of the most widely used and computationally efficient methods for image segmentation.
With regard to Claim 13, Xie and Alizad disclose the ultrasonic diagnostic apparatus according to Claim 1. Xie further discloses wherein the processing circuitry generates a blood flow image as the ultrasonic image from a plurality of pieces of reflected wave data collected along a time series by a transmit aperture synthesis method or a plane wave compound method (Xie, Para 0037; “The velocity vector estimator 210 may utilize any currently known or later developed technique to obtain the beam-angle-independent velocity data, for example … using the transverse oscillation method or synthetic aperture method …”).
With regard to Claim 14, Xie discloses an ultrasonic diagnostic apparatus (Xie, Para 0030; “A system 100 for visualization and quantification of ultrasound imaging data according to embodiments of the present disclosure … a processor 120 …”) comprising processing circuitry (processor 120, as shown in Fig. 1) configured to:
normalize statistical information about blood flow in the vascular region (Xie, Para 0043; “… the minimum and maximum velocity (e.g., yellow for the minimum velocity magnitude of 0 cm/s and red for the maximum velocity, in this case 60 cm/s) …” As shown in Fig. 6C, the velocity magnitude is normalized in a range of [0, 60] cm/s, and flow direction in range of [-180, +180] degrees), and
synthesize the normalized statistical information (Xie, Para 0065; “The system may identify one or more regions … based on the statistical analysis and may designate the subset of pixels associated with … as the ROI. … continue by generating and displaying graphical representations of quantitative information about the flow within the selected ROI.” The disclosed selected ROI combines a subset of pixels and possibly multiple separate regions, and after merging into one ROI, the quantitative information about the flow in the pixels or regions is combined or synthesized).
Alizad in the same field of endeavor discloses acquiring a vascular region by morphology analysis of a spatial distribution based on an ultrasonic image (Alizad, Column 2, Lines 32-34; “FIG. 2 is a flowchart setting forth examples of morphological filtering that can be implemented to generate vessel segment data.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xie, as suggested by Alizad, in order to use morphological analysis to segment blood vessels. One of ordinary skill in the art would have been motivated to make the modification for the benefit of enabling more robust segmentation of blood vessels than basic thresholding method or manual delineation.
With regard to Claim 16, Xie discloses an image processing apparatus comprising processing circuitry (Xie, Para 0030; “A system 100 for visualization and quantification of ultrasound imaging data according to embodiments of the present disclosure … a processor 120 …”) configured to:
divide at least a part of an ultrasonic image into a plurality of regions (Xie, Para 0033; “… the processor 120 may be configured to receive a selection of a region of interest (ROI) within the flow region …”. The disclosed selection of ROI corresponds to the claimed dividing an image into regions);
normalize statistical information about blood flow in a region determined to be a vascular region (Xie, Para 0043; “… the minimum and maximum velocity (e.g., yellow for the minimum velocity magnitude of 0 cm/s and red for the maximum velocity, in this case 60 cm/s) …” As shown in Fig. 6C, the velocity magnitude is normalized in a range of [0, 60] cm/s, and flow direction in range of [-180, +180] degrees); and
synthesize the normalized statistical information (Xie, Para 0065; “The system may identify one or more regions … based on the statistical analysis and may designate the subset of pixels associated with … as the ROI. … continue by generating and displaying graphical representations of quantitative information about the flow within the selected ROI.” The disclosed selected ROI combines a subset of pixels and possibly multiple separate regions, and after merging into one ROI, the quantitative information about the flow in the pixels or regions is combined or synthesized).
Xie does not clearly and explicitly disclose determining whether a region is a vascular region.
Alizad in the same field of endeavor discloses determining whether a region is a vascular region (Alizad, Column 7, Lines 4-5; “In step 202, the microvessel image can be converted to a binary image by setting an intensity threshold. The output binary image, IB(x, z), replaces all pixel values in the input image with luminance greater than a selected threshold with values of 1, and replaces all other pixel values with values of 0”; Column 2, Lines 2-5; “… the binary image contains pixels with first binary values and pixels with second binary values, wherein pixels with the first binary value correspond to segmented vessel.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xie, as suggested by Alizad, in order to determine if a region to be analyzed is vascular. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improving efficiency by focusing on analyzing vascular region only.
With regard to Claim 17, Xie discloses a method comprising: by a computer (Xie, Para 0030; “A system 100 for visualization and quantification of ultrasound imaging data according to embodiments of the present disclosure … a processor 120 …”),
dividing at least a part of an ultrasonic image into a plurality of regions (Xie, Para 0033; “… the processor 120 may be configured to receive a selection of a region of interest (ROI) within the flow region …”. The disclosed selection of ROI corresponds to the claimed dividing an image into regions);
normalizing statistical information about blood flow in a region determined to be a vascular region (Xie, Para 0043; “… the minimum and maximum velocity (e.g., yellow for the minimum velocity magnitude of 0 cm/s and red for the maximum velocity, in this case 60 cm/s) …” As shown in Fig. 6C, the velocity magnitude is normalized in a range of [0, 60] cm/s, and flow direction in range of [-180, +180] degrees); and
synthesizing the normalized statistical information (Xie, Para 0065; “The system may identify one or more regions … based on the statistical analysis and may designate the subset of pixels associated with … as the ROI. … continue by generating and displaying graphical representations of quantitative information about the flow within the selected ROI.” The disclosed selected ROI combines a subset of pixels and possibly multiple separate regions, and after merging into one ROI, the quantitative information about the flow in the pixels or regions is combined or synthesized).
Xie does not clearly and explicitly disclose determining whether a region is a vascular region.
Alizad in the same field of endeavor discloses determining whether a region is a vascular region (Alizad, Column 7, Lines 4-5; “In step 202, the microvessel image can be converted to a binary image by setting an intensity threshold. The output binary image, IB(x, z), replaces all pixel values in the input image with luminance greater than a selected threshold with values of 1, and replaces all other pixel values with values of 0”; Column 2, Lines 2-5; “… the binary image contains pixels with first binary values and pixels with second binary values, wherein pixels with the first binary value correspond to segmented vessel.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xie, as suggested by Alizad, in order to determine if a region to be analyzed is vascular. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improving efficiency by focusing on analyzing vascular region only.
With regard to Claim 18, Xie discloses a non-transitory computer readable medium comprising instructions (Xie, Para 0013; “Any of the methods in accordance with the present disclosure, or steps thereof, may be embodied in non-transitory computer-readable medium comprising executable instructions …”) that cause a computer (Xie, Para 0030; “A system 100 for visualization and quantification of ultrasound imaging data according to embodiments of the present disclosure … a processor 120 …”) to execute:
dividing at least a part of an ultrasonic image into a plurality of regions (Xie, Para 0033; “… the processor 120 may be configured to receive a selection of a region of interest (ROI) within the flow region …”. The disclosed selection of ROI corresponds to the claimed dividing an image into regions);
normalizing statistical information about blood flow in a region determined to be a vascular region (Xie, Para 0043; “… the minimum and maximum velocity (e.g., yellow for the minimum velocity magnitude of 0 cm/s and red for the maximum velocity, in this case 60 cm/s) …” As shown in Fig. 6C, the velocity magnitude is normalized in a range of [0, 60] cm/s, and flow direction in range of [-180, +180] degrees); and
synthesizing the normalized statistical information (Xie, Para 0065; “The system may identify one or more regions … based on the statistical analysis and may designate the subset of pixels associated with … as the ROI. … continue by generating and displaying graphical representations of quantitative information about the flow within the selected ROI.” The disclosed selected ROI combines a subset of pixels and possibly multiple separate regions, and after merging into one ROI, the quantitative information about the flow in the pixels or regions is combined or synthesized).
Xie does not clearly and explicitly disclose determining whether a region is a vascular region.
Alizad in the same field of endeavor discloses determining whether a region is a vascular region (Alizad, Column 7, Lines 4-5; “In step 202, the microvessel image can be converted to a binary image by setting an intensity threshold. The output binary image, IB(x, z), replaces all pixel values in the input image with luminance greater than a selected threshold with values of 1, and replaces all other pixel values with values of 0”; Column 2, Lines 2-5; “… the binary image contains pixels with first binary values and pixels with second binary values, wherein pixels with the first binary value correspond to segmented vessel.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xie, as suggested by Alizad, in order to determine if a region to be analyzed is vascular. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improving efficiency by focusing on analyzing vascular region only.
Claims 5 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Xie and Alizad, in view of Du (US 20190365354 A1; hereafter Du).
With regard to Claim 5, Xie and Alizad disclose the ultrasonic diagnostic apparatus according to Claim 1, including calculating as the statistical information a spectrum, but do not explicitly and clearly disclose computing an absolute velocity at a local blood vessel location using speckle tracking.
Du in the same field of endeavor discloses computing an absolute velocity at a local blood vessel location using speckle tracking (Du, Para 0066; “… the blood flow velocity vector may be calculated based on speckle tracking which utilizing the displacement of the same speckle between two adjacent image frames.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xie and Alizad, as suggested by Du, in order to calculate blood velocity using speckle tracking. One of ordinary skill in the art would have been motivated to make the modification for the benefit of obtaining blood velocity without the need of considering transmission angle in data acquisition or the need of combing data acquired at multiple transmission angles, therefore accelerating image acquisition and/or post-processing.
With regard to Claim 9, Xie and Alizad disclose the ultrasonic diagnostic apparatus according to Claim 1, including normalizing the statistical information of blood velocity, but do not explicitly and clearly disclose performing angular correction to blood velocity based on a main direction of blood flow in a region.
Du in the same field of endeavor discloses performing angular correction to blood velocity based on a main direction of blood flow in a region (Du, Para 0066; “… the blood flow velocity vector may be calculated based on speckle tracking which utilizing the displacement of the same speckle between two adjacent image frames.” Using the disclosed method, the calculated velocity value is directly the velocity value along the blood flow direction, i.e. automatically corrected for transmitting and receiving angles). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xie and Alizad, as suggested by Du, in order to correct blood velocity value based on blood flow direction. One of ordinary skill in the art would have been motivated to make the modification for the benefit of reliably measuring blood velocity by removing its potential dependence on variable transmitting angle as in conventional Doppler method (Du, Para 0093; “With the Doppler method above, according to the ultrasonic signals in different angles, the blood flow velocity values in different angular directions may be respectively obtained”).
With regard to Claim 10, Xie, Alizad and Du disclose the ultrasonic diagnostic apparatus according to Claim 9. Xie further discloses wherein the processing circuitry estimates the main direction of blood flow from a plurality of ultrasonic images adjacent in a frame direction of the region determined to be a vascular region, using a speckle tracking method or a multi-angle Doppler method (Xie, Para 0051; “… vector flow maps according to the present disclosure may be generated using pathlet-based visualization techniques …”; Para 0053; “To generate the pathlets, initially a number of frames of the vector field data are saved and pathlets are generated for each frame … For each subsequent frame, the pathlets are updated based on the velocity vector data associated with the subsequent frames.” The disclosed method for generating pathlet is a tracking method applied to a number of adjacent frames, and the resulted pathlet visualizes flow vector, thus a direction of blood flow).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Xie and Alizad, in view of Torp et al (US 20220151586 A1; hereafter Torp).
With regard to Claim 6, Xie and Alizad disclose the ultrasonic diagnostic apparatus according to Claim 1, but do not clearly and explicitly disclose calculating the statistical information by Fourier analysis in a frame direction of reflected wave data in a region.
Torp in the same field of endeavor discloses calculating the statistical information by Fourier analysis in a frame direction of reflected wave data in a region (Torp, Para 0463; “The oscillations in blood flow characteristics … may be determined from readings of the above mentioned characteristics over time by the Fourier transformation (e.g. Fast Fourier transformation) or complex demodulation of such readings.” The disclosed “time” corresponds to the claimed frame direction). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xie and Alizad, as suggested by Torp, in order to use Fourier analysis to calculate statistical information about blood flow. One of ordinary skill in the art would have been motivated to make the modification for the benefit of Fourier analysis being the most widely used method for converting signals to their frequency domain, and frequency spectrum of blood velocity often revealing physiologically significant findings (Torp, Para 0678; “Fourier transformation revealed the subject's heart beat was around 140 bpm and the presence of further significant frequency component in the arterial flow velocity trace at around 2-5 bpm.”).
Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Xie and Alizad, in view of Watanabe et al (US 20180008152 A1; hereafter Watanabe).
With regard to Claim 8, Xie and Alizad disclose the ultrasonic diagnostic apparatus according to Claim 7, but do not explicitly and clearly disclose wherein
the Doppler spectrum indicates a relationship between echo intensity and blood flow velocity, and
the processing circuitry normalizes the Doppler spectrum based on echo intensity for each region determined to be a vascular region.
Watanabe in the same field of endeavor discloses wherein
the Doppler spectrum indicates a relationship between echo intensity and blood flow velocity (Watanabe, Para 0045; “When the time-series data of such scattered light S is subjected to a fast Fourier transform, as shown in FIGS. 6A and 6B, a real-time Doppler spectrum fRT(ω) having the intensity at a frequency ω … corresponding to the velocity of the blood flow is obtained.”), and
the processing circuitry normalizes the Doppler spectrum based on echo intensity for each region determined to be a vascular region (Watanabe, Para 0071; “… calculating a normalized real-time Doppler spectrum by normalizing the real-time Doppler spectrum by using an average value of the real-time Doppler spectrum in a predetermined normalized region;” Fig. 10 demonstrates the normalizing process).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xie and Alizad, as suggested by Watanabe, in order to generate Doppler spectrum based on and normalized by signal intensity. One of ordinary skill in the art would have been motivated to make the modification for the benefit of precise quantification of blood velocity spectrum by eliminating impact from confounding factors such as noise or partial volume effect.
With regard to Claim 15, Xie and Alizad disclose the ultrasonic diagnostic apparatus according to Claim 14, including synthesizing the Doppler spectrum. Xie further discloses wherein
the statistical information is a Doppler spectrum (Xie, Para 0031; “… a Doppler processor 124 configured to generate Doppler images (e.g. … spectral Doppler …”), and
the processing circuitry performs, for each vascular region, first normalization on the Doppler spectrum based on an area of the vascular region (Xie, Fig. 6C-6D shows histogram with “frequency” (or number of voxels) as vertical axis, and Fig. 6A-6B with “frequency (%)” (with range of 0-1) as vertical axis. Therefore, normalization of histograms based on area of ROIs are performed).
Xie and Alizad do not clearly and explicitly disclose wherein
the Doppler spectrum indicates a relationship between echo intensity and blood flow velocity, and
the Doppler spectrum is normalized based on echo intensity.
Watanabe in the same field of endeavor discloses wherein
the Doppler spectrum indicates a relationship between echo intensity and blood flow velocity (Watanabe, Para 0045; “When the time-series data of such scattered light S is subjected to a fast Fourier transform, as shown in FIGS. 6A and 6B, a real-time Doppler spectrum fRT(ω) having the intensity at a frequency ω … corresponding to the velocity of the blood flow is obtained.”), and
the Doppler spectrum is normalized based on echo intensity (Watanabe, Para 0071; “… calculating a normalized real-time Doppler spectrum by normalizing the real-time Doppler spectrum by using an average value of the real-time Doppler spectrum in a predetermined normalized region;” Fig. 10 demonstrates the normalizing process).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xie and Alizad, as suggested by Watanabe, in order to generate Doppler spectrum based on and normalized by signal intensity. One of ordinary skill in the art would have been motivated to make the modification for the benefit of precise quantification of blood velocity spectrum by eliminating impact from confounding factors such as noise or partial volume effect.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Xie and Alizad, in view of Chiang et al (US 5928153 A; hereafter Chiang).
With regard to Claim 12, Xie and Alizad disclose the ultrasonic diagnostic apparatus according to Claim 2, but do not explicitly and clearly disclose wherein the processing circuitry generates a plurality of pieces of the synthetic statistical information for a predetermined period of time and generates statistical information for display about blood flow velocity from new synthetic statistical information obtained by averaging the pieces of the synthetic statistical information.
Chiang in the same field of endeavor discloses wherein the processing circuitry generates a plurality of pieces of the synthetic statistical information for a predetermined period of time and generates statistical information for display about blood flow velocity from new synthetic statistical information obtained by averaging the pieces of the synthetic statistical information (Chiang, Columns 7-8; “… three sets of Doppler spectrum data … are obtained from the same measurement point in a pulsating flow measured at different times … an averaging process is performed to average the three normalized spectra into a single spectrum. Through this averaging process, noise reduction can be achieved.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Xie and Alizad, as suggested by Chiang, in order to generate multiple spectrum data at different time points and average them. One of ordinary skill in the art would have been motivated to make the modification for the benefit of reducing noise thus improving measurement precision.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI ZHANG whose telephone number is (571)272-7172. The examiner can normally be reached Monday-Friday 8am-5pm E.T..
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/L.Z./ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
