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.
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) 1-3, 5, 7-9, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jain et al. (US 2014/0046189; hereinafter Jain) in view of Baba et al. (US 2009/014759; hereinafter Baba).
Jain shows an ultrasonic diagnostic apparatus and method (abstract, [0024]) comprising: a display unit configured to display the Doppler waveform, the measurement area, and the measurement index (display waveforms, [0026], [0029]; additionally display stress information, [0033]; Figs 2A-2B, 3); a control unit configured to analyze a shape of a Doppler waveform based on a Doppler signal, determine a type of the Doppler signal, determine at least one area of the Doppler waveform, calculate a similarity with respect to the at least one area, determine a measurement area based on the similarity (suitable signal analysis techniques such as curve shape analysis and shape approximations; compare velocity waveform shapes such as triangle, compare area of waveform shapes; [0046]), and calculate a measurement index related to cardiac function of the object based on the measurement area (determine stress level of subject based on calculated amplitudes/peaks of velocity waveforms, [0049]);
Jain also shows wherein the control unit is further configured to determine Doppler signal information with respect to the determined Doppler signal, and determine the at least one area of the Doppler waveform, based on the determined Doppler signal information ([0046]); wherein the control unit is further configured to: determine a first Doppler signal when the shape of the Doppler waveform is “M” or “reversed M”; and determine a second Doppler signal when the shape of the Doppler waveform is "V" or “reversed V" (heartbeat signals include M, reversed M, V, reversed V shapes; [0036], Figs. 2A-2B); wherein the first Doppler signal is a Doppler signal of blood flowing into the heart of an object, and the second Doppler signal is Doppler signal of blood flowing out of the heart of the object (heartbeat signals correspond with systolic and diastolic diagnostic information points, [0036]); wherein the Doppler signal information comprises first Doppler signal information about the first Doppler signal and second Doppler signal information about the second Doppler signal ([0045]); wherein the control unit is further configured to calculate the similarity by comparing the Doppler signal with a pre-learned Doppler signal for the at least one area (compare shape to velocity waveform obtained at other time, [0046]); wherein the control unit is further configured to calculate the similarity for the at least one area, based on a period of the Doppler waveform generated based on the Doppler signal, a cardiac cycle of an object, and a strength of the Doppler signal ([0026], [0030], [0036], [0046]); wherein the measurement area comprises a first measurement area and a second measurement area, the first measurement area is an area based on the first Doppler signal, and the second measurement area is an area based on the second Doppler signal (each Doppler signal measurement is considered to correspond with a measurement area); wherein the measurement index comprises at least one parameter related to a function of the heart (stress index); wherein the at least one area comprises a period of the Doppler waveform generated based on the Doppler signal ([0046]).
Jain fails to show obtaining a first Doppler signal and a second Doppler signal corresponding to inflow or outflow of blood flow in a heart of an object; determine the first Doppler signal as a Doppler signal of blood flowing into the heart of the object and the second Doppler signal as a Doppler signal of blood flowing out of the heart of the object, based on shapes of Doppler waveforms of the first and second Doppler signals respectively; display, through a display unit, a first Doppler waveform as a inflow Doppler waveform indicating blood flowing into the heart, and a second Doppler waveform as an outflow Doppler waveform indicating blood flowing out of the heart, wherein the second Doppler waveform is aligned with the first Doppler waveform based on the measurement area.
Baba discloses an ultrasonic diagnostic imaging apparatus and method. Baba teaches obtaining a first Doppler signal and a second Doppler signal corresponding to inflow or outflow of blood flow in a heart of an object ([0006], [0062], [0079]); determine the first Doppler signal as a Doppler signal of blood flowing into the heart of the object and the second Doppler signal as a Doppler signal of blood flowing out of the heart of the object, based on shapes of Doppler waveforms of the first and second Doppler signals respectively (display controller causes the trace waveform of the left ventricular blood outflow and the trace waveform of the left ventricular blood inflow to be displayed [0116]; Fig. 9, 11); display, through a display unit, a first Doppler waveform as a inflow Doppler waveform indicating blood flowing into the heart, and a second Doppler waveform as an outflow Doppler waveform indicating blood flowing out of the heart, wherein the second Doppler waveform is aligned with the first Doppler waveform based on the measurement area (display in one Doppler spectrum image both the left ventricular outflow and left ventricular inflow waveforms; [0123]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the invention of Jain to measure and display inflow and outflow Doppler waveforms as taught by Baba, in order to provide the user with a display which allows the operator to comprehend values of the inflow and outflow by observing only one image as described by Baba ([0123]), and in order to enable easier calculation of cardiac indices as described by Baba ([0123]).
Claim(s) 6 and 10-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jain et al. (US 2014/0046189; hereinafter Jain) in view of Baba et al. (US 2009/014759; hereinafter Baba) as applied to claims 1, 5, and 9 above, and further in view of Jackson et al. (US 2007/0055158; hereinafter Jackson) and Quattrone-Brown et al. (US 2022/0192627; hereinafter Quattrone).
Jain fails to show wherein the first Doppler signal information comprises an opening time of a tricuspid valve, a closing time of the tricuspid valve, and a location of a synchronization signal, and the second Doppler signal information comprises an opening time of a pulmonary valve, a closing time of the pulmonary valve, and the location of the synchronization signal; wherein the control unit is further configured to: determine one measurement area by matching a synchronization signal of the first measurement area to a synchronization signal of the second measurement area; wherein the at least one parameter comprises a tricuspid valve closing time (TST), a pulmonary valve opening time (ET), a cardiac systolic time (ICT), a cardiac diastolic time (IRT), and a myocardial performance index (MPI); wherein the display unit further displays the at least one parameter; wherein the display unit comprises a first main display area, a second main display area, and a sub display area, the first main display area displays a first Doppler ultrasonic image based on the first Doppler signal, and the second main display area displays a second Doppler ultrasonic image based on the second Doppler signal; wherein the sub display area displays at least one first Doppler ultrasonic image or at least one second Doppler ultrasonic image; wherein, when the first main display area displays the first Doppler ultrasonic image, the sub display area displays the at least one second Doppler ultrasonic image, and wherein, when the second main display area displays the second Doppler ultrasonic image, the sub display area displays the at least one first Doppler ultrasonic image.
Jackson discloses techniques for automated detection of cardiac events with medical ultrasound. Jackson teaches wherein the first Doppler signal information comprises an opening time of a valve, a closing time of the valve, and the second Doppler signal information comprises an opening time of a valve, a closing time of the valve ([0015], [0019], [0024]; Fig. 4). Jackson also teaches wherein the at least one parameter comprises a tricuspid valve closing time (TST), a pulmonary valve opening time (ET), a cardiac systolic time (ICT), a cardiac diastolic time (IRT), and a myocardial performance index (MPI) ([0015], [0019], [0024]; Fig. 4); wherein the display unit further displays the at least one parameter (Fig. 4); wherein the display unit comprises a first main display area, a second main display area, and a sub display area, the first main display area displays a first Doppler ultrasonic image based on the first Doppler signal, and the second main display area displays a second Doppler ultrasonic image based on the second Doppler signal (combined invention of Jain Fig. 2A-2B teaching display of first and second waveforms, 3 and Jackson Fig. 4 [0033] teaching display of additional health parameter); wherein the sub display area displays at least one first Doppler ultrasonic image or at least one second Doppler ultrasonic image (combined invention of Jain Fig. 2A-2B teaching display of first and second waveforms, 3 and Jackson Fig. 4 [0033] teaching display of additional health parameter); wherein, when the first main display area displays the first Doppler ultrasonic image, the sub display area displays the at least one second Doppler ultrasonic image, and wherein, when the second main display area displays the second Doppler ultrasonic image, the sub display area displays the at least one first Doppler ultrasonic image (combined invention of Jain Fig. 2A-2B teaching display of first and second waveforms, 3 and Jackson Fig. 4 [0033] teaching display of additional health parameter).
Quattrone discloses a stress echocardiogram imaging comparison tool. Quattrone teaches wherein the Doppler signal a location of a synchronization signal (myocardial image analysis module aligns the ultrasound image of the patient’s heart at rest and the image of the patient’s heart at stress by using delineated contours, ECG signal to synchronize on the R-wave, and/or speckle tracking; [0035]). Quattrone teaches wherein the control unit is further configured to: determine one measurement area by matching a synchronization signal of the first measurement area to a synchronization signal of the second measurement area ([0035]).
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 combined invention of Jain and Baba to analyze and display opening/closing times of the valves of the patient’s heart as taught by Jackson, as Jackson teaches that the valve opening/closing timings have a diagnostic significance and the automated extraction of these timings provides more efficient examination and diagnosis ([0015]).
It would have been obvious to have modified the combined invention of Jain and Jackson to further utilize a synchronization signal as taught by Quattrone, as Quattrone teaches that use of a synchronization signal is a known expedient to align the images taken at different times (0035]).
Furthermore, while Jackson does not specifically mention the tricuspid valve or the pulmonary valve, it would be within the level of one of ordinary skill in the art, to have modified the combined invention of Jain and Jackson to analyze any known heart valves deemed to be of significance to the user depending on the user’s preference or the patient’s specific disease condition.
Furthermore, a variety of different graphical user interface designs/styles/layout are known to one of ordinary skill in the art, and it would be an obvious design choice to utilize any GUI layout desired by the user including by displaying different waveform images of the valves in the same or in different sub-windows in the user interface and/or displaying different types of health parameters desired to be tracked by the user, in order provide a user friendly interface.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jain et al. (US 2014/0046189; hereinafter Jain) in view of Baba et al. (US 2009/014759; hereinafter Baba), Jackson et al. (US 2007/0055158; hereinafter Jackson) and Quattrone-Brown et al. (US 2022/0192627; hereinafter Quattrone) as applied to claim 14 above, and further in view of Mo et al. (US 6450959; hereinafter Mo).
Jain fails to show wherein the display unit displays a first sample volume gate and a second sample volume gate, and according to a location of the first sample volume gate or the second sample volume gate, the first main display area displays the first Doppler ultrasonic image and the second main display area displays the second Doppler ultrasonic image; when one of the first sample volume gate and the second sample volume gate is located in correspondence to a tricuspid valve, the first main display area displays the first Doppler ultrasonic image, and when one of the first sample volume gate and the second sample volume gate is located in correspondence to a pulmonary valve, the second main display area displays the second Doppler ultrasonic image.
Mo discloses ultrasound B-mode and Doppler flow imaging. Mo teaches wherein the display unit displays a first sample volume gate and a second sample volume gate, and according to a location of the first sample volume gate or the second sample volume gate, the first main display area displays the first Doppler ultrasonic image and the second main display area displays the second Doppler ultrasonic image (multi-gate spectral Doppler displays, Figs. 5 and 7; additional display formats in different sub-windows, Fig. 6).
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 combined invention of Jain, Baba, Jackson, and Quattrone to utilize additional display formats corresponding with different gates as taught by Mo, in order to provide the user with additional diagnostic information in an easily viewed format, in order to more efficiently diagnose the patient.
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797