DETAILED ACTION
This office action is responsive to original claims filed on 02/25/2025. Presently, Claims 1 - 15 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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4, 7-9 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Viggen et al (US 20180344292 A1; hereafter Viggen).
With regard to Claim 1, Viggen discloses a system (the system 100) comprising:
a computer readable memory (Viggen, Para 0019; “The RF or IQ signal data may then be provided directly to a memory 114 for storage …”) storing spectral Doppler data (Viggen, Para 0020; “the system 100 may be an ultrasound system operating in a spectral Doppler mode and used to obtain a pulse wave Doppler spectrum or continuous wave Doppler spectrum (referred to herein as a Doppler spectrum) that includes blood flow velocity data for multiple heart cycles (e.g., beats).”);
a display (Viggen, Para 0022; “Ultrasound spectrum (e.g., waveforms) and/or images may be generated from the acquired data (at the controller 116) and displayed to the operator or user on the display device 118.”); and
at least one processor (the system controller 116) configured to:
determine whether individual ones of a plurality of cardiac cycles in the spectral Doppler data are of high quality or of low quality (Viggen, Para 0028; “… in many cases it can be technically challenging to acquire robust or consistent data along the heart cycles of a pulse wave or continuous wave Doppler spectrum …”; Para 0041; “A user may focus on the different individual traced cycles of the Doppler spectrum 204 … in order to see the measurement parameters for the currently selected cycle. As a result, a user may more easily and quickly determine which cycles of the traced Doppler spectrum 204 should be kept for final analysis (and for final patient diagnosis) and which should be discarded.” These disclosures indicate that the acquired cardiac cycles are determined to be robust or consistent (to be kept), or non-robust or -consistent (to be discarded)), based at least in part on heart rate variability (Viggen, Para 0039; “As an example, and as shown in FIG. 3, the displayed average measurement parameters include … average envelope time …”; Para 0041; “… some cycles may be outliers and may not be representative of a patient's heart condition (and thus should be discarded). ” These disclosures indicate that selection of cardiac cycles can be based on determining whether an individual cycle is an outlier with regard to its “envelope time”, or variability of envelope time. Parameter “envelope time” directly estimates heart rate, as supported by the Application, Page 13, Lines 9-10: “… a range of [0.375 to 1.5] seconds which corresponds to a heart rate range of [40 to 160] beats per minute (BPM).”); and
generate display data based on the determination (Viggen, Para 0043; “… a user input approving all the remaining traced cycles …”. As a result of the determination or selection, some cycles are selected for further analysis),
wherein based on the display data, the display is configured to provide one or more of
a visual indication of cardiac cycles of the plurality of cardiac cycles determined to be of high quality (Viggen, Para 0043; “FIG. 6 shows an example display output 600 showing the trace outline 302 on the three finally selected cycles of the Doppler spectrum 204 (e.g., cycles one, two, and four)”) and
a visual indication of cardiac cycles of the plurality of cardiac cycles determined to be of low quality (note that in Viggen, not showing trace outline for the non-selected cycles can be interpreted as a visual indication).
With regard to Claim 2, Viggen discloses the system of Claim 1, wherein the display is configured to provide the spectral Doppler data as a spectrogram (Viggen, Para 0017; “Acquired Doppler data may then be used to generate the Doppler spectrum and display the Doppler spectrum via a display device of a user interface, such as the displayed Doppler spectrum of FIG. 2.” In the example of Fig. 2, the spectrogram is 204).
With regard to Claim 4, Viggen discloses the system of Claim 1, wherein the at least one processor is further configured to determine a parameter measurement based on cardiac cycles of the plurality of cardiac cycles determined to be of high quality (Viggen, Para 0044; “… a worksheet (e.g., report) 702 generated for the approved (and stored) measurement parameters of the approved cycles of the Doppler spectrum of FIG. 6. As shown in FIG. 7, the worksheet includes a measurement parameter column 704 listing the desired (e.g., user selected) measurement parameters, an average value column 706 that lists the values of the listed measurement parameters, averaged over all the approved cycles of the Doppler spectrum …”), and wherein optionally the display is further configured to provide the parameter measurement (the work sheet 702 as demonstrated in Fig. 7, wherein the average value column 706 displays values for multiple parameter measurements).
With regard to Claim 7, Viggen discloses the system of Claim 1, further comprising an ultrasound probe configured to acquire the spectral Doppler data (Viggen, Para 0019; “… a diagnostic ultrasound probe 106 (or transducer) to emit ultrasonic signals (e.g., continuous or pulsed) into a body or volume (not shown) of a subject.”).
With regard to Claim 8, Viggen discloses a method (Viggen, Para 0017; “FIGS. 9A-9B show a method for automatically analyzing the displayed Doppler spectrum (e.g., displayed in any of FIGS. 2-6 and 10-12).”) comprising:
determining whether individual ones of a plurality of cardiac cycles in spectral Doppler data are of high quality or of low quality, based at least in part on heart rate variability (Viggen, Para 0060; “The method continues from both 926 and 924 to 928 where the method includes determining whether an input selection of one or more cycles out of all cycles of the traced Doppler spectrum to include/exclude from the traced data has been received.” Para 0061; “The method at 934 includes determining whether an input approving the remaining cycles of the traced Doppler spectrum has been received.” The disclosed methods of 928 and 934 in Fig. 9B are to determine which cycles to include and which to exclude. As discussed above for Claim 1, the determination is based on heart rate variability); and
displaying the spectral Doppler data (Viggen, Para 0051; “The displayed Doppler spectrum may be displayed via a display device of a user interface of an ultrasound system …”) and a visual indication of one or more of cardiac cycles of the plurality of cardiac cycles determined to be of high quality and cardiac cycles of the plurality of cardiac cycles determined to be of low quality (Viggen, Para 0060; “For example, as shown in FIG. 5, discarding the data of the excluded cycle may also include updating the displayed trace line to only be shown on the remaining cycles and not on the rejected cycle.”).
With regard to Claim 9, Viggen discloses the method of Claim 8, further comprising:
generating a spectrogram based on the spectral Doppler data (Viggen, Para 0052; “The method begins at 902 by displaying an acquired Doppler spectrum (e.g., a Doppler spectrum generated from acquired Doppler ultrasound data) … ”; see step 902 in Fig. 9A);
extracting a spectral envelope of the spectrogram (Viggen, Para 0054; “Tracing the Doppler spectrum may also be referred to herein as outlining a boundary of the Doppler spectrum or drawing a boundary line of the Doppler spectrum.”); and
determining the plurality of cardiac cycles within at least a portion of the spectral Doppler data based, at least in part, on the spectral envelope (Viggen, Para 0054; “… the method continues to 906 to automatically trace the cycles (e.g., the envelope, or negative or positive peaks, of each heart beat or cycle) of the displayed Doppler spectrum … automatically tracing the cycles of the Doppler spectrum at 906 may additionally or alternatively include determining and displaying a set of points at detected landmarks …, such as for a mitral valve E/A velocity measurement or maximum velocity point measurements.”. Individual cycles are determined after their envelope or negative or positive peaks are traced (see Fig. 3) or a set of landmark points are detected (see Fig. 11)).
With regard to Claim 15, Viggen discloses a computer program product with instructions (Viggen, Para 0051; “Instructions for carrying out method 900 may be executed by a controller or processor (such as processor 116 shown in FIG. 1) based on instructions stored on a memory of (or coupled to) the processor …”) that when executed by at least one processor of a system, cause the system to perform the method of Claim 8.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Viggen, in view of Sulas et al (Computer Methods and Programs in Biomedicine 190 (2020) 105336; hereafter Sulas).
With regard to Claim 3, Viggen discloses the system of Claim 2, and further discloses wherein the visual indication comprises highlighting the cardiac cycles of the plurality of cardiac cycles determined to be of high quality in a first color (Viggen, Para 0043; “FIG. 6 shows an example display output 600 showing the trace outline 302 on the three finally selected cycles of the Doppler spectrum 204 (e.g., cycles one, two, and four)”).
Viggen does not explicitly and clearly disclose highlighting the cardiac cycles of the plurality of cardiac cycles determined to be of low quality in a second color different than the first color.
Sulas in the same field of endeavor discloses highlighting the cardiac cycles of the plurality of cardiac cycles determined to be of low quality in a second color different than the first color (Sulas, Fig. 4 (cited below) highlights the low-quality cycles using blue trace line only (Fig. 4b), different from both blue trace line and red/green boxes for the “complete and measurable” cycles (Fig. 4a)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Viggen, as suggested by Sulas, in order to highlight the non-selected cycles using a different color. One of ordinary skill in the art would have been motivated to make the modification for the benefit of avoiding mis-diagnosis by clearly labeling the low-quality cycles differently.
Fig. 4 of Sulas
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Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Viggen, in view of Gupta et al (US 20140358000 A1; hereafter Gupta).
With regard to Claim 5, Viggen discloses the system of Claim 1, further comprising a buffer (the memory 114) configured to store additional Doppler spectral data (Viggen, Para 0044; “… the ultrasound information may be stored temporarily in the memory 114 during an imaging session and processed in less than real-time in a live … operation.” In this disclosure of “less than real-time” processing, when some data is processed, other acquired data (corresponding to “additional” data of Application) is temporarily stored in memory), wherein the at least one processor is further configured to determine whether individual ones of a plurality of cardiac cycles in the additional spectral Doppler data are of high quality or of low quality, based, at least in part on the heart rate variability (Viggen, Para 0060; “The method continues from both 926 and 924 to 928 where the method includes determining whether an input selection of one or more cycles out of all cycles of the traced Doppler spectrum to include/exclude from the traced data has been received.” Para 0061; “The method at 934 includes determining whether an input approving the remaining cycles of the traced Doppler spectrum has been received.” The disclosed methods of 928 and 934 in Fig. 9B are to determine which cycles to include and which to exclude. As discussed above for Claim 1, the determination is based on heart rate variability).
Viggen does not clearly and explicitly disclose wherein, when all of the plurality of cardiac cycles are determined to be of low quality, additional data is used for selecting cardiac cycles.
Gupta in the same field of endeavor discloses wherein, when all of the plurality of cardiac cycles are determined to be of low quality, additional data is used for selecting cardiac cycles (Gupta, Para 0083; “If more segments 304, 306 are desired (step S438), processing branches back to step S434.” Here each of the disclosed “segments 304, 306” is a segment of spectrogram with 5 or more cycles of high quality. When more “good” segment is desired (e.g. all cycles are determined to be low quality as claimed), processing goes back to step S434, i.e. to check if there are 5 or more cycles available for quality determination (Para 0080)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Viggen, as suggested by Gupta, in order to analyze additional saved data when current data does not contain high-quality cardiac cycles. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved efficiency and consistency by saving part of acquired data in a same scan as backup so that more scan or visit of patient is not needed.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Viggen and Gupta, further in view of Kohls et al (US 20180150598 A1; hereafter Kohls).
With regard to Claim 6, Viggen and Gupta disclose the system of Claim 5, but do not explicitly and clearly disclose wherein when the buffer does not include additional spectral Doppler data, the at least one processor is configured to cause the display to prompt a user to acquire the additional spectral Doppler data.
Gupta further discloses wherein when the buffer does not include additional spectral Doppler data, the at least one processor is configured to acquire the additional spectral Doppler data (Gupta, Para 0081; “If, on the other hand, fewer than five cycles 200 are available (S434), return is made to step S404.” Here the disclosed “step S404” is “A Doppler signal is captured during a brief period of time from the received ultrasound” (Para 0071), which is performed by “user or operator, who may be a clinician, midwife, general practitioner …” (Para 0071). The cited disclosure means that if data of fewer than 5 cycles are available for analysis, new data is captured by a user or operator). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Viggen and Gupta, as further suggested by Gupta, in order to acquire additional data when such data is not available. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved efficiency by acquiring extra amount of data in a same scan as backup so that more visit of patient is less likely to be needed.
Viggen and Gupta as discussed above do not explicitly and clearly disclose prompting a user to acquire more data.
Kohls in the same field of endeavor discloses prompting a user to acquire more data (Kohls, Para 0016; “… the remote evaluation system may notify the operator of the medical diagnostic imaging system to acquire additional medical images (e.g., missing image views), re-measure the structure of interest (e.g., anatomical measurement is outside non-zero predetermined threshold) …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Viggen and Gupta, as suggested by Kohls, in order to prompt user to acquire more data. One of ordinary skill in the art would have been motivated to make the modification for the benefit of timely collecting all the needed images with high quality so that accurate diagnosis can be achieved in an efficient way.
Claim 10 and 13-14 is rejected under 35 U.S.C. 103 as being unpatentable over Viggen, in view of Palti (US 20160206287 A1; hereafter Palti).
With regard to Claim 10, Viggen discloses the method of Claim 9, and further discloses wherein determining the plurality of cardiac cycles comprises locating, based at least in part, on the average cardiac cycle duration, a plurality of local maxima and a plurality of local minima in the portion of the spectral Doppler data (E wave velocity (1106), deceleration slope end (end of 1108), A wave velocity (1104) in Fig. 11 cited below), wherein individual ones of the plurality of cardiac cycles are located between individual ones of the plurality of local maxima and local minima (Viggen, Para 0054; “… automatically tracing the cycles of the Doppler spectrum at 906 may additionally or alternatively include determining and displaying a set of points at detected landmarks that are determined from the automatically determined boundary trace of the Doppler spectrum, such as for a mitral valve E/A velocity measurement or maximum velocity point measurements.” Para 0057; “in the mitral valve E/A velocity measurement case, three points (E wave velocity, deceleration slope end, A wave velocity) may be displayed”. In the cited Fig. 11, clearly individual cardiac cycles can be located between the located points, e.g. E wave velocity 1106 located in adjacent peaks).
Fig. 11 of Viggen
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Viggen does not clearly and explicitly disclose applying an auto-correlation function to the spectral envelope, and determining an average cardiac cycle duration based, at least in part, on a first non-zero lag peak of the auto-correlation function.
Palti in the same field of endeavor discloses applying an auto-correlation function to the spectral envelope (Palti, Para 0068; “the step of identifying the cardiac cycles (i.e., S130) includes two major stages … autocorrelation of the contour of the spectrogram or the raw data.”), and determining an average cardiac cycle duration based, at least in part, on a first non-zero lag peak of the auto-correlation function (Palti, Para 0068; “The peaks of the autocorrelation are detected and the average time difference between the peaks is calculated.” In this disclosure, the “time difference between the peaks” is cardiac cycle duration). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Viggen, as suggested by Palti, in order to apply auto-correlation to the spectrum envelope to determine an averaged cardiac cycle duration. One of ordinary skill in the art would have been motivated to make the modification for the benefit of accurately identifying individual cardiac cycles by locating and analyzing characteristic features within duration of each cycle, and auto-correlation being one of the most robust methods for determining periodicity in a signal with noise.
With regard to Claim 13, Viggen and Palti disclose the method of Claim 10. Viggen further discloses comprising determining a parameter measurement based on cardiac cycles of the plurality of cardiac cycles determined to be high quality (Viggen, Para 0044; “… a worksheet (e.g., report) 702 generated for the approved (and stored) measurement parameters of the approved cycles of the Doppler spectrum of FIG. 6. As shown in FIG. 7, the worksheet includes a measurement parameter column 704 listing the desired (e.g., user selected) measurement parameters, an average value column 706 that lists the values of the listed measurement parameters, averaged over all the approved cycles of the Doppler spectrum …”) and optionally further comprising displaying the parameter measurement (the work sheet 702 as demonstrated in Fig. 7, wherein the average value column 706 displays values for multiple parameter measurements).
With regard to Claim 14, Viggen and Palti disclose the method of Claim 13. Viggen further discloses wherein the parameter comprises a resistive index, a peak systolic velocity, an end diastolic velocity, or a combination thereof (Viggen, Para 0046; “The three features include: a maximum E wave velocity, a deceleration slope, and a maximum A wave velocity. … At the end of diastole, the left atrium contracts, forcing more blood into the left ventricle. This gives a second inflow wave in the Doppler spectrum, known as the A wave.” The disclosed “maximum A wave velocity” is an end diastolic velocity).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Viggen, in view of Gilbert et al (US 20220211342 A1; hereafter Gilbert), further in view of Abe (US 20150223781 A1; hereafter Abe).
With regard to Claim 11, Viggen discloses the method of Claim 8, and further discloses wherein a cardiac cycle of the plurality of cardiac cycles is determined to be of low quality based on the heart rate variability of the cardiac cycle (Viggen, Para 0041; “A user may … in order to see the measurement parameters for the currently selected cycle. As a result, a user may more easily and quickly determine which cycles of the traced Doppler spectrum 204 should be kept for final analysis (and for final patient diagnosis) and which should be discarded. For example, some cycles may be outliers …”. The disclosed “measurement parameters” include “envelope time” (Para 0039), which directly estimates heart rate. Hence, this disclosure indicates that a cycle can be discarded from analysis if its heart rate estimate deviates much from that of other cycles, i.e. high variability).
Viggen does not explicitly and clearly disclose determining quality of a cardiac cycle based on comparison of its heart rate variability to a threshold value, or comparison of a plurality of cross-correlation coefficients for the cardiac cycle to a threshold value.
Gilbert in the same field of endeavor discloses determining quality of a cardiac cycle based on comparison of the assessment metric to a threshold value (Gilbert, Para 0036; “the selection step can be performed using a confidence metric for each cardiac cycle image 42 that provides an indication of how expected and/or “normal” the measurement result(s) is for the specific cardiac cycle, e.g., a measurement variance confidence metric. … any images/cardiac cycles falling outside of an acceptable range around the predetermined value can be discarded from the final measurement determination.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Viggen, as suggested by Gilbert, in order to compare the metric to a threshold for selection. One of ordinary skill in the art would have been motivated to make the modification for the benefit of achieving consistent outcome by using a quantitative and objective method of selection.
Viggen and Gilbert do not explicitly and clearly disclose determining quality of a cardiac cycle based on comparison of a plurality of cross-correlation coefficients for the cardiac cycle to a threshold value.
Abe in the same field of endeavor discloses determining quality of a cardiac cycle based on comparison of a plurality of cross-correlation coefficients for the cardiac cycle to a threshold value (Abe, Para 0162; “Based on the cross-correlation coefficient value between the first waveform and the second waveform, the search unit 111 determines the similarity of the two waveforms.” Para 0203; “…the search unit 111 starts the search process when similarity obtained by monitoring drops below a threshold stored in advance.” Here the disclosed “two waveforms” are “second waveform” and “first waveform”, which correspond to already acquired and stored Doppler signals and the signals “obtained sequentially in the search process” (Para 0154 and 0155)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Viggen and Gilbert, as suggested by Abe, in order to compare cross-correlation coefficients of a cardiac cycle to a threshold for quality determination. One of ordinary skill in the art would have been motivated to make the modification for the benefit of quantitatively assessing similarity between the current cycle and other cycles so that Doppler data representative of a patient’s status can be reliably collected.
With regard to Claim 12, Viggen, Gilbert and Abe disclose the method of Claim 11, but do not explicitly and clearly disclose calculating the plurality of cross-correlation coefficients by cross-correlating the cardiac cycle to other of the plurality of cardiac cycles.
Abe further discloses calculating the plurality of cross-correlation coefficients by cross-correlating the cardiac cycle to other of the plurality of cardiac cycles (Abe, Para 0162; “Based on the cross-correlation coefficient value between the first waveform and the second waveform, the search unit 111 determines the similarity of the two waveforms.” Here the disclosed “two waveforms” are “second waveform” and “first waveform”, which correspond to already acquired and stored Doppler signals and the signals “obtained sequentially in the search process” (Para 0154 and 0155)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Viggen, Gilbert and Abe, as further suggested by Abe, in order to calculate cross-correlation coefficients between different cardiac cycles. One of ordinary skill in the art would have been motivated to make the modification for the benefit of quantitatively assessing similarity between the current cycle and other cycles so that consistent Doppler data representative of a patient’s status can be reliably collected.
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