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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 2, 2026 has been entered.
Response to Arguments
Applicant’s remarks concerning the previous § 103 rejections have been fully considered and are persuasive. However, updated grounds of rejection are made in further view of the Houlton reference which address the newly added limitations.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-3 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0066798 A1 to Albert (hereinafter “Albert”) in view of US 2011/0112421 A1 to Zanetti et al. (hereinafter “Zanetti”) in view of US 2008/0015653 A1 to Siejko et al. (hereinafter “Siejko”) in view of US 2015/0038856 A1 to Houlton et al. (hereinafter “Houlton”).
Regarding Claims 1-3 and 10-14, Albert teaches:
A method for quantifying heart failure (see e.g. “provide an early warning for potential cardiac problems and signal the need for the patient to seek treatment prior to a fatal cardiac event” in the abstract; also see e.g. “heart failure” in Paras. 5, 6, 60, 102, and 122), wherein the method comprises: 2
obtaining a plurality of segments of a signal (see e.g. Para. 28: “multiple SCG cycles may be taken during the first time period of recording an SCG”) recorded with an accelerometer placed on 3the chest of a person for measuring accelerations and vibrations of the chest wall of 4the person caused by myocardial movement (see e.g. Para. 24: “to record a seismocardiogram (SCG) from the smartphone's accelerometer by detecting vibrations on a patient's chest corresponding to heart motion for a first time period”), wherein the plurality of segments include sub-audible and audible frequency components (see e.g. Para. 96: “FIG. 6 illustrates one variation of the resulting SCG raw trace. In FIG. 6, the trace, taken from the accelerometer of the smartphone, has been marked to indicate characteristic waveforms. This trace has not been filtered or smoothed, which may result in a more regular an easily read SCG waveform”; a raw unfiltered accelerometer signal includes both sub-audible and audible frequency components, as acknowledged by Applicant on page 1 of the specification; also note the inclusion of Zanetti below, in which a similar raw accelerometer signal is bandpass filtered to obtain both sub-audible and audible frequencies, i.e. the raw signal also had both of those types of frequencies) each segment covers a cardiac 5cycle (see e.g. Para. 28: “Each "cycle" of an SCG cycle corresponds to a single, and complete, cardiac cycle for that patient”), 6
aligning the plurality of segments including both the sub-audible and audible frequency components (see e.g. Para. 36: “averaging each SCG cycle waveform after aligning them”; as noted above, Albert’s SCG cycle waveform necessarily has both sub-audible and audible frequency components), filtering the plurality of segments including both the audible and sub-audible frequency components with a 7filter (see e.g. Para. 28: “the SCG signal may be filtered, smoothed, and/or otherwise processed to enhance the signal received. High frequency filtering may be applied to remove noise”; as noted above, Albert’s SCG cycle waveform necessarily has both sub-audible and audible frequency components), and determining a mean segment based on the plurality of filtered 9segments (see e.g. Para. 28: “multiple cycles may be averaged …”), 10
determining a first temporal feature in the mean segment corresponding to the aortic valve closing (AC) and determining a second temporal feature in the mean segment corresponding to the mitral valve opening (MO) and determining a measure based on at least one of the amplitude and the location in time of both the 12first and second temporal features in the mean segment (see e.g. Para. 27: “a time point or region corresponding to: mitral valve closure, isovolumetric contraction, aortic valve opening, rapid ejection, aortic valve closure, mitral valve opening, and rapid filling. These time points may be used to measure or otherwise derive additional information about the SCG and thus cardiac health of the subject from whom the reading was taken. Characteristic regions may generally be recognized based on the overall shape of the SCG curve(s) or average SCG cycle(s)” and Para. 28: “For example, the apparatus may determine for each SCG cycle the time of mitral valve closure (MC), aortic valve opening (AO), Aortic valve closure (AC) and mitral valve opening (MO), and use these estimated times to derive values such as isovolumetric contraction time (ICT or IVCT, equal to the time from MC to AO), ejection time (ET, equal to the time from AO to AC)), and isovolumetric relaxation time (IRT or IVRT, equal to the time from AC to MO). The derived values (ICT, ET, IRT, etc.) may be averaged by SCG cycles. These values may also be used to derive one or more indexes, and the index value may be based on the average values, or a raw index value for each SCG cycle may be averaged (or both)”; and also see Para. 28: “characteristic regions of the SCG, which may be determined based on peaks in the SCG”; also see FIG. 5), 11and 13
providing output information quantifying a degree of heart failure based on the determined measure (see e.g. Para. 31: “display, transmit and store the index of cardiac function”, and Para. 38: “the index for cardiac health, or a simplified indicator of the index (red light/danger, green light/good, yellow light/caution, etc.).”, and Para. 88: “the cardiac performance monitoring system may be configured to determine one or more index of cardiac function (index of cardiac fitness). The parameters, including the index, may be displayed, stored, and/or uploaded to a remote site for patient monitoring by a physician.”; concerning heart failure specifically, see e.g. Paras. 5-6, 59-60, 102, 122).
Although Albert teaches filtering the plurality of segments as discussed above, Albert fails to specifically teach a band-pass filter having a lower cutoff frequency below 1 Hz and an upper cut-off frequency in 8the range 100-250 Hz. However, Zanetti teaches a similar invention including the collection of SCG data via an accelerometer (see e.g. abstract, Para. 2) in which the signals are filtered with a band-pass filter having a lower cutoff frequency below 1 Hz and an upper cut-off frequency in 8the range 100-250 Hz (see Para. 37: “The SCG accelerometer signals are buffered and bandpass amplified with a flat filter having corner frequencies of approximately 0.3 Hz and 170 Hz”). It would have been obvious to one of ordinary skill in the art as of Applicant’s effective filing date to modify Albert to utilize the upper and lower filter frequencies taught by Zanetti because this would merely involve choosing an already-known frequency band (i.e. known from Zanetti’s teaching) to allow subsequent processing steps to be carried out on the frequency band of interest relevant to this particular data while e.g. eliminating or significantly reducing noise. Furthermore, it would have been obvious to one of ordinary skill in the art as of Applicant’s effective filing date to engage in routine experimentation to discover the optimal upper and lower filter frequencies based upon various factors known and understood to those skilled in the art, in order to eliminate noise and highlight the frequency band of interest. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). The Examiner further notes that Zanetti’s values of 0.3 Hz and 170 Hz are sufficiently close to the claimed values of 0.2 Hz and 175 Hz (in claims 11-12) to render them prima facie obvious, particularly in view of the rationales explained above. See generally MPEP § 2144.05(I) (“Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”).
Albert further teaches that the device can include a microphone in addition to the accelerometer (see Para. 69 of Albert: “The telecommunications devices can include (or may be adapted to include) a microphone capable of receiving ultrasonic sound” and Para. 79: “a telecommunications device, such as a smartphone 301, can utilize its built-in components (e.g., microphone, audio codec, and CPU) to acquire, digitize, demodulate, and process SCG and ECG data in real-time”).
However, Albert in view of Zanetti fails to specifically teach:
identifying a plurality of heart sounds in the audio signal, wherein each heart sound relates to a single cardiac cycle, and dividing the recorded signal into the plurality of segments based on the identified plurality of heart sounds;
determining the second heart sound (S2) in the audible frequency component of each of the plurality of segments, and 4aligning the plurality of segments by the determined second heart sound (S2) of each 5segment;
determining a first point in time in the mean segment corresponding to the onset of a heart sound 4(S1 or S2), and determining the first temporal feature and/or the second temporal feature 5further comprises: determining the first temporal feature and/or the second temporal feature 6relative to the first point in time
Another reference, Siejko, teaches a related invention including collecting acoustic data from an accelerometer or microphone placed on the chest (see Para. 32: “… in one embodiment, the acoustic sensor is a microphone. In another embodiment, the acoustic sensor is an accelerometer. In one embodiment, as shown in FIG. 1, the acoustic sensor is an external sensor 130 attached on to body 101 near heart 102; the Examiner further notes that Para. 57 of Siejko explains how heart sounds recorded from one sensor can be used for e.g. aligning segments recorded with a separate sensor, as will be more appreciated when taking the additional portions cited below into context) and
identifying a plurality of heart sounds in the audio signal wherein each heart sound relates to a single cardiac cycle (see e.g. abstract: “Each acoustic sensor signal segment includes heart sounds …” and Para. 33: “includes representations or indications of detected cardiac events A and V and heart sounds S1, S2, and S3), and dividing the recorded signal into the plurality of segments based on the identified plurality of heart sounds (see Para. 57),
determining the second heart sound (S2) in the audible frequency component of each of the plurality of segments (see e.g. Para. 33: “includes representations or indications of detected cardiac events A and V and heart sounds S1, S2, and S3” and Para. 34: “the signal segments may be aligned by any of the cardiac events and heart sounds represented or indicated in the phonocardiograph image, such as any of A, V, S1, S2, and S3, for example, depending on the specific trend to be observed”; also see Para. 57; note that acoustic data can either be acquired by a microphone or an accelerometer as noted in e.g. Paras. 32, 38), and 4aligning the plurality of segments by the determined second heart sound (S2) of each 5segment (see e.g. Para. 34: “the signal segments may be aligned by any of the cardiac events and heart sounds represented or indicated in the phonocardiograph image, such as any of A, V, S1, S2, and S3, for example, depending on the specific trend to be observed”; also see all of Para. 57), and
determining a first point in time in the mean segment corresponding to the onset of a heart sound 4(S1 or S2) (see e.g. Para. 34: “times of heart sounds and/or time intervals between any two of the cardiac events and heart sounds over multiple cardiac cycles”), and determining the first temporal feature and/or the second temporal feature 5further comprises: determining the first temporal feature and/or the second temporal feature 6relative to the first point in time (see e.g. Para. 57: “points of segmenting are related to times associated with the event markers. At 840, signal alignment module 553 aligns all the acoustic sensor signal segments by the selected type of cardiac events or heart sounds. In one embodiment, this alignment facilitates observation of timing trends related to the heart sounds, especially time intervals between a selected type of the heart sounds and the selected type of cardiac events”).
Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant’s effective filing date to further modify Albert to further include the detection of various acoustic data including heart sound S2, either from the accelerometer data and/or from a microphone, and using the identified heart sounds for segmenting, aligning segments, and identifying relative points in time of various signal regions/markers, as taught by Siejko in the cited portions above, because doing so would advantageously and predictably increase the accuracy of the processed data as well as provide additional useful contextual information for the collected data, and furthermore because Siejko teaches that heart sounds are one of the multiple suitable alternatives for aligning segments of collected data that each correspond to a cardiac cycle (see e.g. Para. 34: “In other embodiments, the signal segments may be aligned by any of the cardiac events and heart sounds represented or indicated in the phonocardiograph image, such as any of A, V, S1, S2, and S3, for example, depending on the specific trend to be observed”) and Siejko also demonstrates that a microphone and an accelerometer are suitable known alternatives for acquiring the heart sound data.
Albert also fails to specifically teach determining the numerical signal value or amplitude of the first temporal feature, wherein the value/amplitude comprises a peak or extreme value of the temporal feature in the mean segment, and using that value/amplitude in the subsequent determination of outputting the information related to heart failure (rather, Albert states a bit more vaguely that the “overall shape” of the SCG curve is used, and not necessarily the actual numeric value of the amplitude at any given point(s)). To address this deficiency, attention is further directed to another reference, Houlton, which teaches a similar invention which uses SCG to assess cardiac functions (see e.g. the abstract: “assessment of cardiac contractility in a subject by recording precordial acceleration signals. This includes, but is not limited to, the method and apparatus of seismocardiography (SCG)”), including heart failure (see e.g. Paras. 2, 40 and 91-92), specifically teaches that a magnitude (i.e. amplitude) of a first temporal feature, such as the aortic valve opening or other peak/extreme values, may be used (see Para. 45 which is exclusively focused on discussing the magnitude), in addition to or instead of other measures such as the slope of the SCG curve (see e.g. Para. 19-20, 46, 59, and claims 1 and 5, all of which list magnitude among other possible measures, such as slope). Note that Houlton also teaches that SCG can be averaged over plural cardiac cycles (see e.g. Para. 68) similar to Albert, i.e. the “magnitude” referred to in e.g. Para. 45 can refer to magnitudes of the mean SCG segment. Accordingly, it would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Albert to specifically measure the amplitude/magnitude of the first temporal feature, as taught by Houlton, because Houlton demonstrates that this was among the known useful metrics/measures by which to evaluate the SCG data for various cardiac function(s), including heart failure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Cited in previous actions:
Busse ‘989: see portions cited in ISR; also see Para. 89;
Scheiner ‘005: see Para. 43;
Koivisto ‘717: see Paras. 13, 38;
Siejko ‘186: see claim 16;
Giorgis ‘875: see abstract, Paras. 17 and 38.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792