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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/23/25 has been entered.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bjaerum et al. (US 2017/0090571; hereinafter Bjaerum) in view of Keshet et al. (US 2020/0107818; hereinafter Keshet).
Bjaerum shows an ultrasonic diagnosis apparatus (abstract) comprising a processor, the processor configured to: receive an operation to select one type of Doppler mode from among a plurality of types of Doppler mode, including at least one of a pulsed wave (PW) or a continuous wave (CW) ([0029], [0046], [0058]); generate an ultrasonic image representing a cross-section of a subject based on reflected-wave data that is obtained by performing an ultrasound scan on the subject ([0036], Fig. 2); determine a measurement item to be executed in the selected one type of Doppler mode based on at least one of the cross-section represented by the ultrasonic image or the waveform representing the velocity of blood flow (knowing the parameters under which a protocol is being carried out including ultrasound type improves the accuracy of placing and utilizing analytical tools, [0017]; if a Doppler cursor is selected, the system may automatically enter Doppler mode with the sample volume at the selected position; alternatively, if a color flow ROI is selected, the system may automatically enter color flow mode with the color ROI centered at the selected position; automatically place measurement calipers, ROIs, Doppler sample volumes, [0052]; certain tools may be ultrasound mode dependent, [0063]); display the measurement item on a touch screen based on a result of the determination thereof (Fig. 2).
Bjaerum also shows wherein the processor automatically executes the at least one executable measurement item ([0017], [0023], [0052], [0058], [0063]); wherein the processor displays, on a display device, an operation button with which an instruction is made to execute the at least one executable measurement item ([0016], [0052]); the ultrasonic image represents a B-mode image; and when the selected one type of Doppler mode represents the PW, the processing circuitry is configured to determine the measurement item based on cursor position information indicating a position of a Doppler cursor on the B-mode image ([0052]); wherein the processor determines the at least one executable measurement item based on cursor position information indicating a position of a Doppler cursor ([0052]); wherein the processor determines the at least one executable measurement item based on a B-mode image that is used for the ultrasonic transmission/reception in the Doppler mode ([0018], [0058]).
Bjaerum fails to show generate a waveform representing a velocity of blood flow of the subject based on the reflected-wave data. Bjaerum also fails to show wherein the plurality of measurement items include at least two of an E/A ratio, wherein E is an early diastolic filling wave and A is an atrial filling wave, an early diastolic wave of mitral annular motion e', a left ventricular outflow tract (LVOT), a right ventricular outflow tract (RVOT), a tricuspid regurgitation (TR), and an aortic valve (AV), and the processing circuitry is further configured to identify which of a continuous wave (CW), a pulsed wave (PW), and a tissue Doppler imaging-pulsed wave (TDI-PW) the selected one type of Doppler mode represents, and based on a result of the identification thereof, extract the measurement item from among the plurality of measurement items; wherein when the selected one type of Doppler mode represents a continuous wave (CW), the processing circuitry is further configured to identify a type of cross-section obtained by the ultrasound scan in a B mode on the subject, and based on a result of identification thereof, extract at least one of the measurement item representing a tricuspid regurgitation (TR), and the measurement item representing an aortic valve (AV) from among the plurality of measurement items; wherein the processing circuitry is further configured to: when the type of cross-section represents the TR, display the measurement item representing the TR on the touch screen, and accept the execution of the measurement item; and when the type of cross-section represents the AV, display the measurement item representing the AV on the touch screen, and accept the execution of the measurement item; wherein when the one type of Doppler mode represents a pulsed wave (PW), the processing circuitry is further configured to identify a waveform related to the Doppler data, and based on a result of identification thereof, extract at least one of the measurement item representing an E/A ratio, wherein E is an early diastolic filling wave and A is an atrial filling wave, the measurement item representing a left ventricular outflow tract (LVOT), and the measurement item representing a right ventricular outflow tract (RVOT) from among the plurality of measurement items; wherein when the waveform related to the Doppler data corresponds to the E/A ratio, the processing circuitry is further configured to display the measurement item representing the E/A ratio on the touch screen, and accept the execution of the measurement item; wherein the waveform related to the Doppler data does not correspond to the E/A ratio, the processing circuitry is further configured to: identify a cursor position in a Doppler image related to the Doppler data; when the cursor position is at the LVOT, display the measurement item representing the LOVT and accept the execution of the measurement item; and when the cursor position is at the RVOT, display the measurement item representing the ROVT and accept the execution of the measurement item; wherein when the one type of Doppler mode represents a tissue Doppler imaging-pulsed wave (TDI-PW), the processing circuitry is further configured to display the measurement item representing an early diastolic wave of mitral annular motion, and accept the execution of the measurement item; wherein the ultrasonic image representing the cross-section of the subject is a B-mode image and the processing circuitry is further configured to recognize the cross-section of the subject represented by the B-mode image based on a trained model that has been trained with a teacher B-mode image labelled with a cross-section, and determine the at least one measurement item based on the recognized cross-section; wherein the processing circuitry is further configured to: generate, from the reflected-wave data, a Doppler image according to the selected one type of Doppler mode, and determine the at least one measurement item corresponding to the Doppler image based on a trained model that has been trained with a teacher Doppler image labelled with a measurement item.
Keshet discloses ultrasound cardiac Doppler study automation. Keshet teaches generate a waveform representing a velocity of blood flow of the subject based on the reflected-wave data ([0070]-[0071]). Keshet also teaches wherein the plurality of measurement items include at least two of an E/A ratio, wherein E is an early diastolic filling wave and A is an atrial filling wave, an early diastolic wave of mitral annular motion e', a left ventricular outflow tract (LVOT), a right ventricular outflow tract (RVOT), a tricuspid regurgitation (TR), and an aortic valve (AV), and the processing circuitry is further configured to identify which of a continuous wave (CW), a pulsed wave (PW), and a tissue Doppler imaging-pulsed wave (TDI-PW) the selected one type of Doppler mode represents, and based on a result of the identification thereof, extract the measurement item from among the plurality of measurement items ([0089], [0097]-[0098], [0102]); wherein when the selected one type of Doppler mode represents a continuous wave (CW), the processing circuitry is further configured to identify a type of cross-section obtained by the ultrasound scan in a B mode on the subject, and based on a result of identification thereof, extract at least one of the measurement item representing a tricuspid regurgitation (TR), and the measurement item representing an aortic valve (AV) from among the plurality of measurement items ([0069], [0094]); wherein the processing circuitry is further configured to: when the type of cross-section represents the TR, display the measurement item representing the TR on the touch screen, and accept the execution of the measurement item; and when the type of cross-section represents the AV, display the measurement item representing the AV on the touch screen, and accept the execution of the measurement item ([0069], [0097]);
wherein when the one type of Doppler mode represents a pulsed wave (PW), the processing circuitry is further configured to identify a waveform related to the Doppler data, and based on a result of identification thereof, extract at least one of the measurement item representing an E/A ratio, wherein E is an early diastolic filling wave and A is an atrial filling wave, the measurement item representing a left ventricular outflow tract (LVOT), and the measurement item representing a right ventricular outflow tract (RVOT) from among the plurality of measurement items ([0069], [0094], [0098]);
wherein when the waveform related to the Doppler data corresponds to the E/A ratio, the processing circuitry is further configured to display the measurement item representing the E/A ratio on the touch screen, and accept the execution of the measurement item ([0098]); wherein the waveform related to the Doppler data does not correspond to the E/A ratio, the processing circuitry is further configured to: identify a cursor position in a Doppler image related to the Doppler data; when the cursor position is at the LVOT, display the measurement item representing the LOVT and accept the execution of the measurement item; and when the cursor position is at the RVOT, display the measurement item representing the ROVT and accept the execution of the measurement item ([0069], [0094], [0098]);wherein when the one type of Doppler mode represents a tissue Doppler imaging-pulsed wave (TDI-PW), the processing circuitry is further configured to display the measurement item representing an early diastolic wave of mitral annular motion, and accept the execution of the measurement item ([0069], [0097]-[0098], [0133]); wherein the ultrasonic image representing the cross-section of the subject is a B-mode image and the processing circuitry is further configured to recognize the cross-section of the subject represented by the B-mode image based on a trained model that has been trained with a teacher B-mode image labelled with a cross-section, and determine the at least one measurement item based on the recognized cross-section ([0031]-[0033], [0041], [0080]-[0085]);wherein the processing circuitry is further configured to: generate, from the reflected-wave data, a Doppler image according to the selected one type of Doppler mode, and determine the at least one measurement item corresponding to the Doppler image based on a trained model that has been trained with a teacher Doppler image labelled with a measurement item ([0031]-[0033], [0041], [0080]-[0085]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Bjaerum to generate a waveform as taught by Keshet, in order to further automate the analysis of cardiac function, thereby providing an improved diagnostic result according to the type of Doppler ultrasound study performed, as described by Keshet ([0069]-[0071], [0097], [0100], [0102]).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797