DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/5/2025 has been entered.
Response to Amendment
The amendment filed on 12/5/2025 has been entered. Claims 1 and 9-11 remain pending the application.
Response to Arguments
Applicant's arguments filed on 12/5/2025 have been fully considered but they are moot or not persuasive.
Applicant argues on page 6 that the 112b rejection has been overcome due to the amendments. The Examiner respectfully disagrees, antecedent basis issues still remain as the previously set forth two-dimensional ultrasound data has not been described as having been rearranged. The Examiner recommends amending the claim to recite “wherein the two-dimensional ultrasound image data of the target is rearranged by time phase”. Accordingly, this argument is not persuasive.
Applicant argues on pages 7-8 that the recited limitations are not a mental process because of the limitations related to converting 2D data to 3D and acquiring ultrasound images. The Examiner respectfully disagrees. As discussed below these are merely details related to the extra-solution activity of outputting data or to the extra-solution activity of data gathering. See MPEP 2106.05(g). Therefore, they do not integrate the judicial exception into a practical application or amount to significantly more. The Examiner is not asserting that they can be performed in the mind, only that they do not integrate the judicial exception into a practical application or amount to significantly more.
Applicant argues on pages 8-9 that the recited limitations related to converting 2D data to 3D and acquiring ultrasound images integrate the judicial exception into a practical application. The Examiner respectfully disagrees. As discussed below these are merely details related to the extra-solution activity of outputting data or to the extra-solution activity of data gathering. See MPEP 2106.05(g). Therefore, they do not integrate the judicial exception into a practical application or amount to significantly more. Data gathering and outputting data are listed as examples of extra-solution activity in previously cited MPEP 2106.05(g).
The Applicant argues on pages 9-10 that the Examiner has not countered legal citations to case law but the Examiner follows guidance provided by the MPEP and leaves interpretation of case law to other employees as the USPTO. The Examiner is not ignoring Applicants arguments, the Examiner has addressed the Applicant’s arguments by categorizing the limitations as an extra-solution activity of outputting data and gathering data as recited in MPEP 2106.05(g). Applicant argues that the Examiner did not look to the claim as a whole, the Examiner respectfully disagrees. Each and every limitation in the claims have been addressed. Accordingly, this argument is not persuasive.
Applicant argues on pages 10-14 that the previously cited art does not disclose newly added limitations to the claims. This argument is moot in view of the new grounds of rejection necessitated by amendment which relies on newly cited sections of Kang and Auvray to disclose these limitations in the claims. Kang determines blood flow at different sections of the target, which reads on the broadest reasonable interpretation of “a certain point” as each section could be considered a certain point in the target. Accordingly, this argument is moot and not persuasive.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 9-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 11, the claims recite the limitation " the two-dimensional ultrasound image data of the target, which has been rearranged by time phase in the cycle of the pulse of blood flow in the target". There is insufficient antecedent basis for this limitation in the claim. Although the claims set forth two-dimensional ultrasound image data of the target, they do not set forth that they have been rearranged by time phase in the cycle of the pulse of blood flow in the target. For examination purposes, this limitation will be interpreted as simply referring to the previously set forth two-dimensional ultrasound data.
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 and 9-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract without significantly more.
Regarding claim 1 and 11, the claims recite the claims recites rearranging acquired ultrasound images based on the phase of a pulse of blood flow at a certain point which is merely an abstract idea in the form of a mental process of recognizing and categorizing images based on phase data.
This judicial exception is not integrated into a practical application because the limitations related to processing circuitry are merely instructions to implement the abstract idea on a computer or merely uses a computer as tool to perform an abstract idea. See MPEP 2106.05(f). The limitations related to generating and displaying 3D images of the motion of the heart are merely an insignificant extra-solution of outputting data. See MPEP 2106.05(g). The limitations related to acquiring 2D ultrasound data and performing Fourier analysis on Doppler signals of the target merely recite details related to an insignificant extra-solution of data gathering. See MPEP 2106.05(g).
The claims does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the limitations related to processing circuitry are merely instructions to implement the abstract idea on a computer or merely uses a computer as tool to perform an abstract idea. See MPEP 2106.05(f). The limitations related to generating and displaying 3D images of the motion of the heart are merely an insignificant extra-solution of outputting data. See MPEP 2106.05(g). The limitations related to acquiring 2D ultrasound data and performing Fourier analysis on Doppler signals of the target merely recite details related to an insignificant extra-solution of data gathering. See MPEP 2106.05(g).
Regarding claim 9, the limitations in claim 9 do not integrate the judicial exception into a practical application because the limitations merely recite details related to an insignificant extra-solution of data gathering. See MPEP 2106.05(g). Additionally, the limitations in claim 9 do not amount to significantly more because the limitations merely recite details related to an insignificant extra-solution of data gathering. See MPEP 2106.05(g).
Regarding claim 10, the limitations in claim 10 do not integrate the judicial exception into a practical application because the limitations merely recite additional details related to an insignificant extra-solution of outputting data. See MPEP 2106.05(g). Additionally, the limitations in claim 10 do not amount to significantly more because the limitations merely recite details related to an insignificant extra-solution of outputting data. See MPEP 2106.05(g).
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 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 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. (US20190209134, hereafter Kang), Fernando et al. (US20050065439, hereafter Fernando), Auvray et al. (US20210390698, hereafter Auvray), and Hsu et al. (US20180310914, hereafter Hsu).
Regarding claims 1 and 11, Kang discloses in Figures 1-4 an apparatus comprising processing circuitry configured to and non-transitory computer read-able medium having computer-readable codes that, when executed by a computer (Kang, Para 2; “One or more embodiments relate to an ultrasound imaging apparatus and a method of controlling the same”) (Kang, Para 43; “The controller 120 may include a memory for storing a program or data to perform functions of the ultrasound diagnosis apparatus 100 and a processor for processing the program or data. For example, the controller 120 may control the operation of the ultrasound diagnosis apparatus 100 by receiving a control signal from the input interface 170 or an external apparatus”), cause the computer to:
processing circuitry configured to perform an ultrasonic scan on a target being at least one of an umbilical cord and a placenta (Kang, Para 62; “For example, when the object is set to a fetus and the ROI is set to a region including fetal umbilical vessels made of twisted arteries and veins, the ROI may be divided as follows. The processor 310 may automatically recognize the fetal umbilical vessels in the set ROI. The processor 310 may divide the set ROI into a plurality of sections by automatically determining at least one or a combination of the number of the plurality of sections, a size of each of the plurality of sections, and a shape of each of the plurality of sections based on shapes and sizes of the recognized fetal umbilical vessels. For example, the processor 310 may define the plurality sections so that a region corresponding to each artery of the umbilical vessels and a region corresponding to each vein of the umbilical vessels are divided as different sections”);
sequentially acquire two-dimensional ultrasound image data including a time sequence of images of the target based on a result of the ultrasound scan (Kang, Para 94; "even when an object is moving, the ultrasound imaging apparatus 300 may generate spectral Doppler images of a plurality of sections of an ROI in real time") (Kang, Figures 5A-6B; showing 3D images) (Kang, Para 24; “FIGS. 5A, 5B, and 5C are views illustrating an example where the ultrasound imaging apparatus sets a region of interest (ROI) in an ultrasound image of an object and divides the ROI into a plurality of sections, according to an embodiment”) (Kang, Para 66; “The processor 310 may generate a plurality of spectral Doppler images respectively corresponding to the plurality of sections of the ROI based on the obtained blood flow data. The spectral Doppler images refer to images in which a velocity of blood flow with time is represented as a waveform.”); and
identify a cycle of a pulse of blood flow at a certain spatial point in a blood vessel of the at least one of the umbilical cord and the placenta (at least one of a plurality of sections) on blood flow data of the target represented by the sequentially acquired two-dimensional ultrasound image data (Kang, Para 64; “The processor 310 may obtain blood flow data corresponding to each of the plurality of sections. The blood flow data may include at least one or a combination of a velocity, a cycle, and a pattern of blood flow”) (Kang, Para 66; “The processor 310 may generate a plurality of spectral Doppler images respectively corresponding to the plurality of sections of the ROI based on the obtained blood flow data. The spectral Doppler images refer to images in which a velocity of blood flow with time is represented as a waveform”) (Kang, Para 8; “generate a plurality of spectral Doppler images respectively corresponding to the plurality of sections, and determine, based on a peak velocity value of blood flow”) (Kang, Para 62; “For example, when the object is set to a fetus and the ROI is set to a region including fetal umbilical vessels made of twisted arteries and veins, the ROI may be divided as follows. The processor 310 may automatically recognize the fetal umbilical vessels in the set ROI. The processor 310 may divide the set ROI into a plurality of sections by automatically determining at least one or a combination of the number of the plurality of sections, a size of each of the plurality of sections, and a shape of each of the plurality of sections based on shapes and sizes of the recognized fetal umbilical vessels. For example, the processor 310 may define the plurality sections so that a region corresponding to each artery of the umbilical vessels and a region corresponding to each vein of the umbilical vessels are divided as different sections”), based on the information of the blood flow, which is a power component of a color Doppler signal (Hamada, Para 21; “A color doppler mode processing circuit 5 extracts the echo components of blood flows, tissues, and contrast medium by the Doppler effect, and generates so-called color flow mapping data (blood flow image data) that expresses the spatial distributions of average velocity, variance, power, and the like in color”) (Hamada, Para 3; “A ultrasonic diagnosis apparatus which equips a color doppler mode displays the two-dimensional distributions of velocity, power, and variance based on a doppler signal concerning a moving target such as a blood flow”).
Kang does not clearly and explicitly disclose performing Fourier analysis of a power component of Doppler signals corresponding to the certain spatial point in time to acquire blood flow data; generating, three-dimensional image of the target corresponding to each time phase of the cycle of the pulse of blood flow in the target, based on the two-dimensional ultrasound image data of the target, which has been rearranged by time phase in the identified cycle of the pulse of blood flow at the certain spatial point in the target being the at least one of the umbilical cord and the placenta; and controlling a display to display the generated three-dimensional image data.
In an analogous umbilical blood flow analysis field of endeavor Fernando discloses performing Fourier analysis of a power component of Doppler signals to acquire blood flow data (Fernando, Para 50; “An example of the estimated spectrum of a portion of a Doppler signal recorded from the umbilical artery of an 18 week old fetus and the corresponding integrated spectrum are depicted in FIGS. 3 and 4 respectively. The power spectrum was estimated as the periodogram of a Hann-windowed 512-sample segment of data. The FFT size was 1024 samples.”) (Fernando, Para 67-72; “Reconstruction of Mean Blood Velocity Waveforms. Generally, the power spectrum has been estimated using a fast Fourier transform (FFT) algorithm. Once the spectrum is estimated, a threshold level is chosen manually such that it is larger than the noise level. The lowest and the highest frequency values at which the spectral powers equal the threshold level are selected as the minimum and the maximum signal frequencies. A method which may be superior to using an FFT is the Pisarenko harmonic decomposition algorithm (PHD), wherein the single frequency approximation for a narrowband lowpass signal embedded in white noise using PHD is approximately the power-weighted mean frequency of the signal. In preliminary analysis, only signals whose bandwidth and maximum frequency were much smaller than the sampling frequency of thee digitized signal were used. However, experimental results show that the approximation is valid for signals up to one-fourth of the sampling frequency.”) (Fernando, Para 105-113 discussing this in greater detail”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kang to include performing Fourier analysis of a power component of Doppler signals corresponding to the certain spatial point in time to acquire blood flow data as taught by Fernando in order to use a well understood and reliable method of determining blood flow data from Doppler ultrasound data.
Kang as modified by Fernando above is interpreted as disclosing performing Fourier analysis of a power component of Doppler signals corresponding to the certain spatial point in time to acquire blood flow data because Kang acquires blood flow data at specific sections of the target and is modified by Fernando to do so by performing Fourier analysis of the Doppler signals as cited above.
In an analogous cardiovascular ultrasound imaging field of endeavor Auvray discloses generating images of a target corresponding to each time phase of the cycle of a pulse of blood flow in the target, which has been rearranged by time phase in the identified cycle of the pulse of blood flow, and controlling a display to display the images (Auvray, Para 61; “As explained in more detail above, in order to recreate an undistorted 3-D image of a region of interest 1 of the cardiovascular system of a patient from a temporal sequence 15 of IVUS images 150, it is necessary to spatially reorder the temporal sequence 15 of IVUS images 150”) (Auvray, Para 65; “the processor arrangement 16 is adapted to gate the sequence 15 of IVUS images 150 into a plurality of groups or volumes of IVUS images 150, wherein within each group or volume the IVUS images 150 correspond to the same phase of different cardiac cycles”) (Auvray, Para 11; “The present invention seeks to provide an image processing apparatus adapted to convert a temporal sequence of intravascular ultrasound (IVUS) images corresponding to different phases of at least one cardiac cycle into a spatially ordered sequence of these images.”) (Auvray, Para 14 and 61-71; discussing how the images are initially grouped by phase then rearranged based on temporal order before generation of the 3D image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hamada to generating, image of the target corresponding to each time phase of the cycle of the pulse of blood flow in the target, which has been rearranged by time phase in the identified cycle of the pulse of blood flow, and controlling a display to display the generated image data in order to reduce distortion in the image as taught by Auvray (Auvray, Para 61).
Kang as modified by Fernando above is interpreted as disclosing generating, three-dimensional image of the target corresponding to each time phase of the cycle of the pulse of blood flow in the target, based on the two-dimensional ultrasound image data of the target, which has been rearranged by time phase in the identified cycle of the pulse of blood flow at the certain spatial point in the target being the at least one of the umbilical cord and the placenta because Kang acquires blood flow data at specific sections of the target and is modified by Auvray rearrange images based on phase as cited above.
Hamada does not clearly and explicitly disclose generating 3D ultrasound image data of the target using based on the 2D ultrasound image data of the target.
In an analogous 3D ultrasound imaging field of endeavor Hsu discloses using a plurality of 2D images to generate a 3D image (Hsu, Para 7; “continuously scan two-dimensional (2D) images that can be used to generate a three-dimensional (3D) image”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hamada to generating 3D ultrasound image data of the target using based on the 2D ultrasound image data of the target in order to allow for a low cost 3D imaging probe as taught by Hsu (Hsu, Para 5).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kang, Fernando, Auvray, and Hsu as applied to claim 1 above, and further in view of Takeshi (WO2014021402A1, hereafter citing to a machine translation of WO2014021402A1).
Regarding claim 9, Kang as modified by Fernando, Auvray, and Hsu above discloses all of the limitations of claim 1 as discussed above.
Kang does not clearly and explicitly disclose wherein the processing circuitry is further configured to perform the ultrasound scan by obtaining a received signal with respect to each of scan lines in the target by applying averaging to a plurality of received signals of the scan lines obtained by transmitting and receiving ultrasound waves a plurality of times with respect to each of the scan lines, or by performing low-pass filtering similar to the averaging, and performing high-pass filtering on the received signal in a frame direction.
In an analogous ultrasound imaging field of endeavor Takeshi discloses
performing low-pass filtering similar to averaging (Takeshi, claim 3; “performs an averaging process on a plurality of received signals of each scanning line obtained by performing ultrasonic transmission / reception a plurality of times for each scanning line, or a low pass similar to the adding average process”), and
performing high-pass filtering on the received signal in a frame direction to acquire information on motion of a part (Takeshi, Pg 10, Para 7; “the control unit 18 performs high-pass filter processing (for example, IIR filter processing) on the reception signals (reflected wave data) acquired by each of the plurality of scanning lines forming the first scanning range in the frame direction to move the moving body”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kang to include performing low-pass filtering similar to the averaging, and performing high-pass filtering on the received signal in a frame direction to acquire information on the heartbeats of the fetus in order to improve image quality as taught by Takeshi (Takeshi, Pg 3, Para 6).
Kang as modified by Fernando, Auvray, Hsu, and Takeshi above is interpreted as disclosing these limitations in the claims because Kang discloses tracking a target including a placenta or umbilical cord and is modified by Takeshi to use filtering to imaging a moving part. A person having ordinary skill in the art would understand a placenta or umbilical cord move due to blood flow so Takeshi would be applicable.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kang, Fernando, Auvray and Hsu as applied to claim 1 above, and further in view of Wischmann et al. (US20080226149, hereafter Wischmann).
Regarding claim 10, Kang as modified by Fernando, Auvray, and Hsu above discloses all of the limitations of claim 1 as discussed above.
Kang does not clearly and explicitly disclose wherein the processing circuitry configured to generate the three-dimensional image data in the cycle by using, among the sequentially acquired two-dimensional ultrasound image data, images of different places in the target acquired at a same time phase in the cycle.
In an analogous imaging of cyclic targets in a patient field of endeavor Wischmann discloses generate a plurality of images in the cycle (Wischmann, Para 8; “A plurality of heart images are generated in each of a plurality of respiratory and cardiac phases with a first imaging modality”) by using a plurality of images of different places of a part acquired at a same time phase in the cycle (Wischmann, Para 8-9; “The images with a common cardiac phase and the selected respiratory phase are combined into a series of respiratory compensated images at the plurality of cardiac phases […] The images are translated in accordance with the respiratory movement vector and are further adjusted in accordance with a heart shape and motion model. The translated and adjusted images are then combined”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kang wherein the processing circuitry configured to generate the three-dimensional image data in the cycle by using, among the sequentially acquired two-dimensional ultrasound image data, images of different places in the target acquired at a same time phase in the cycle in order to create a combined image which compensates for motion as taught by Wischmann (Wischmann, Para 6-8).
Kang as modified by Fernando, Auvray, Hsu, and Wischmann above is interpreted as disclosing wherein the processing circuitry configured to generate the three-dimensional image data in the cycle by using, among the sequentially acquired two-dimensional ultrasound image data, images of different places in the periodically moving part acquired at a same time phase in the cycle because Kang as modified by Auvray, and Hsu above discloses generating a 3D image using 2D images as discussed above and Wischmann modifies Kang to use images at different locations from the same phase of a cycle to generate a combined image.
Conclusion
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/JOHN D LI/Primary Examiner, Art Unit 3798