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 .
Election/Restrictions
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/12/2025.
Applicant’s election without traverse of claims 1-14 in the reply filed on 11/12/2025 is acknowledged.
Claims 1-14 are hereby under examination.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed 9/22/2023 and 02/21/2024 have been considered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 106, 1500, and 1508. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 1106, 1116, 1118, 1122, and 1514. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because reference characters 1510 and 1512 in the drawings do not match up to their corresponding description in the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 11 is objected to because of the following informalities: "second component signal" should read "the second component signal" for claim language consistency. Appropriate correction is required.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts, including performing, using a blood pressure (BP) cuff of a BP cuff system, a blood pressure measurement of a subject to obtain one or more blood pressure values corresponding to the subject. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of analyzing the sound waveform signal to identify characteristics of the heart of the subject sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 fails to recite any additional elements that integrate the identified characteristics of the heart of the subject into a practical application. The identification of characteristics of the heart alone do not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the displayed SVR value, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of performing, using a blood pressure (BP) cuff of a BP cuff system, a blood pressure measurement of a subject to obtain one or more blood pressure values corresponding to the subject; inflating, based on the one or more blood pressure values corresponding to the subject, the BP cuff to a subject specific pressure value; capturing, using the BP cuff system, while the BP cuff is inflated to the subject specific pressure value, a pulse pressure waveform signal associated with an artery of the subject; and obtaining a sound waveform signal associated with a heart valve of the subject by filtering the pulse pressure waveform signal to extract sound components associated with an opening or closing of the heart valve. Performing a blood pressure measurement using a BP cuff and then inflating the BP cuff to a supra systolic value is well-understood, routine and conventional activity for those in the field of medical diagnostics to capture different forms of cardiac/blood pressure signals. The steps of capturing a pulse pressure waveform signal associated with an artery of the subject and obtaining a sound waveform signal associated with a heart valve of the subject by filtering the pulse pressure waveform signal to extract sound components associated with an opening or closing of the heart valve are merely pre-solution data gathering and processing activity. Further, the performing, inflating, capturing and obtaining steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and processing. The comparing and calculating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims. Dependent claims 2-3 further limit the blood pressure values and define the particular anatomy that is of interest. Dependent claims 4-8 further define the processing of the sound waveform and pulse pressure signals. Dependent claims 9-14 add limitations regarding which sound waveform signals are analyzed to determine a metric of interest.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ogura (US Patent Pub. No. 20040064056).
Regarding Claim 1, Ogura discloses a method for noninvasively performing cardiac auscultation (The present invention relates to an apparatus and a method for detecting a heart sound of a living subject, at a position distant from a chest of the subject. [0002]), comprising:
performing, using a blood pressure (BP) cuff (cuff 12 [0029]) of a BP cuff system (a physical-information obtaining apparatus 10 [0028]), a blood pressure measurement of a subject to obtain one or more blood pressure values corresponding to the subject (As shown in FIG. 2, the cuff 12 includes a belt-like cover bag 16 which is formed of a non-stretchable and considerably rigid cloth and has substantially the same length as that of a common inflatable cuff which is used to measure a blood pressure of an upper arm of a patient. [0029]; In the cover bag 16, there are provided a large cuff 18 and the small cuff 20 each [0030]; Examiner notes cuff 12 includes large cuff 18 and small cuff 20 as seen in fig 2);
inflating, based on the one or more blood pressure values corresponding to the subject, the BP cuff to a subject specific pressure value (In FIG. 8, first, at Step S1 (hereinafter, "Step" is omitted) corresponding to the small-cuff-pressure control means 94, the control device 46 starts the air pump 56 and operates the pressure control valve 54, so that the pressing pressure P.sub.K2 of the small cuff 20 is kept at a considerably low pressure of, e.g., 40 mmHg. [0049]; The target pressure PM.sub.2 is prescribed at such a value which assures that the press surface 30 which is provided on the inner surface of the cuff 12 and to which the pressure-pulse-wave sensors 28 are fixed, is pressed against the upper arm 14, but does not occlude the flow of blood through a brachial artery 98 of the upper arm 14. [0041]);
capturing, using the BP cuff system, while the BP cuff is inflated to the subject specific pressure value, a pulse pressure waveform signal associated with an artery of the subject (Then, at S4, the control device 46 reads in the pressure-pulse-wave signal SM supplied from the multiplexer 60. [0050]; fig 8);
obtaining a sound waveform signal associated with a heart valve of the subject by filtering the pulse pressure waveform signal to extract sound components associated with an opening or closing of the heart valve (A main component of the pressure-pulse-wave signal SM is the pressure pulse wave BAP produced from the brachial artery 98. However, heart sounds which are produced when the valves of the heart are opened and closed, propagate through the blood vessels. Therefore, the pressure-pulse-wave signal SM contains the heart-sound component. Thus, the heart sounds can be detected at the upper arm 14 by extracting, from the pressure-pulse-wave signal SM, a signal having frequencies in the frequency band generally had by heart sounds. [0043]; More specifically described, at S8, the control device 46 subjects the pressure-pulse-wave signal SM detected by the optimum element A selected at S7, to a digital filter, so as to extract a component having frequencies of above 30 to 600 Hz. Thus, the heart-sound component is extracted from the pressure-pulse-wave signal SM. [0053]; fig 8);
and analyzing the sound waveform signal to identify characteristics of the heart of the subject (At S9, the control device 46 processes a waveform of the heart-sound component extracted at S8, so as to determine a prescribed periodic point on the waveform as one of two reference points to determine a pulse-wave propagation time DT. [0054]; fig 9).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ogura (US Patent Pub. No. 20040064056) as applied to claim 1 above in view of Lowe (US Patent Pub. No. 20160345840).
Regarding Claim 2, Ogura discloses the invention as discussed above in claim 1. Ogura further discloses the one or more blood pressure values comprise a systolic blood pressure (SBP) of the subject (The blood-pressure determining means 92 determines, based on the change of the cuff-pulse-wave signal SW obtained during the slow deflation of the pressing pressure of the large cuff 18 by the large-cuff-pressure control means 90, a systolic blood pressure BP(SYS), a mean blood pressure BP(MEAN), and a diastolic blood pressure BP (DIS) of the patient [0040]). Ogura fails to disclose the subject specific pressure value comprises a supra systolic blood pressure (sSBP) greater than the SBP.
However, Lowe teaches a method of obtaining a pulse pressure waveform signal of a subject (Various cardiovascular medical parameters which are determined by the method and apparatus of the present invention are set forth and illustrated in FIG. 3. [0121]; Aortic incident pulse pressure, α. [0129]) in which BP cuffs are inflated to a supra systolic blood pressure of the subject (First both cuffs are inflated to a suprasystolic pressure. The intra-arterial pressure waves within the brachial artery thus first impinge on the proximal cuff. Recordings of proximal cuff pressure oscillations and heart activity is made. The proximal cuff is then deflated to a subdiastolic pressure, allowing the intra-arterial pressure waves to impinge on the distal cuff. Measurements of the distal cuff pressure oscillations and heart activity are made. [0099]).
Lowe is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Ogura such that the BP cuff is inflated to a supra systolic blood pressure of the subject, rather than the target pressure PM.sub.2, to capture a pulse pressure waveform signal associated with an artery of the subject, as taught by Lowe because both steps can be used to obtain a pulse pressure waveform signal. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding Claim 3, Ogura in view of Lowe teaches the invention as discussed above in claim 2. Ogura further discloses the BP cuff is a brachial cuff, the artery is a brachial artery of the subject, and the heart valve is an aortic valve of the subject (Therefore, it is desirable that one of the pressure-sensing elements 32 that is located right above, or in the vicinity of, the brachial artery 98 be selected as the optimum element A that can detect, with the highest sensitivity, the pressure pulse wave. [0042]; The sensor 28 has a press surface 30 which is defined by a semiconductor chip such as monocrystalline silicon and has a length of about 13 mm in a lengthwise direction of the cuff 12… each pressure-pulse-wave sensor 28 has fifteen pressure sensing elements 32 [0032]; fig 3).
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ogura (US Patent Pub. No. 20040064056) as applied to claim 1 above, and further in view of Selvaraj (US Patent Pub. No. 20180303434).
Regarding Claim 4, Ogura discloses the invention as discussed above in claim 1. Ogura fails to disclose prior to analyzing the sound waveform signal, indexing the sound waveform signal to identify cardiac cycle events of the subject.
However, Selvaraj teaches prior to analyzing a sound waveform signal (The time series of morphological events and calculated signal features may be input to the block 416, where potential artifacts including presence of arrhythmia, motion, anomalies, and outliers may be detected and rejected from the time series of signal features.; fig 4), indexing the sound waveform signal to identify cardiac cycle events of a subject (In block 414, morphological events are detected in the PCG signal, including peaks of S1 and S2 sounds in each cardiac cycle that help to determine cardiac timing signal features such as the PEP and left ventricular ejection time (LVET). [0045]; fig 4).
Selvaraj is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Ogura such that prior to analyzing the sound waveform signal, the sound waveform signal is indexed to identify cardiac cycle events of the subject, as taught by Selvaraj, because cardiac cycle events occur due to the opening and closing of valves and the sound waveform signal corresponds to the cardiac cycle events. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Regarding Claim 5, Ogura in view of Selvaraj teaches the invention as discussed above in claim 4. Ogura in view of Selvaraj fails to teach indexing the sound waveform signal comprises indexing, based on the pulse pressure waveform signal, the sound waveform signal to identify the cardiac cycle events.
However, Selvaraj teaches indexing a sound waveform signal comprises indexing, based on a PPG signal, the sound waveform signal to identify cardiac cycle events. (In block 412, one or more morphological events may be extracted from the PPG signal, including the onset and peak of the PPG pulse, from which the first derivative of the PPG pulse (the maximal slope of the upstroke PPG pulse) may be determined. The PPG signal and/or derivative thereof allow determination (e.g., calculation) of PPG-derived signal features and cardiac timing features such as the PAT and/or the PTT by combining other features from the ECG and/or PCG signals. [0045]; FIG. 5 illustrates a combination of waveforms 500 from which a method may be performed to calculate cardiac timing signal features according to one or more embodiments. In particular, FIG. 5 shows a few cardiac cycles of simultaneously recorded ECG, PPG, and PCG signals using sensor device 100, and the detected morphological events such as R wave peaks of ECG, onset trough of PPG, and peaks of S1 and S2 sounds in PCG. The onset of the PPG pulse may be used to determine the time delays from an R peak of ECG and a peak of S1 sound of PCG. [0049]; figs 4 & 5).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Ogura in view of Selvaraj such that indexing the sound waveform signal comprises indexing, based on the pulse pressure waveform signal, the sound waveform signal to identify the cardiac cycle events, because Selvaraj teaches PPG signals can be used to determine sound components of sound waveform signals and PPG signals have a pulse pressure component. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Regarding Claim 6, Ogura in view of Selvaraj teaches the invention as discussed above in claim 4. Ogura in view of Selvaraj fails to teach the method further comprises: capturing, concurrently to the BP cuff system capturing the pulse pressure waveform signal, an electrocardiogram (ECG) of the subject; and indexing the sound waveform signal comprises indexing, based on the ECG, the sound waveform signal to identify the cardiac cycle events.
However, Selvaraj teaches capturing, concurrently to a PPG signal, an electrocardiogram (ECG) of a subject (involves simultaneous measurement of single or multiple lead ECG signals, single or multiwavelength PPG signals, and/or PCG signals, and extraction of multivariate signal features including magnitudes and timing intervals within or between the detected physiological signals [0028]);
and indexing a sound waveform signal comprises indexing, based on the ECG, the sound waveform signal to identify cardiac cycle events (In method 400, a suite of morphological detection algorithms may be utilized to detect various fiduciary points or events in ECG, PPG, and PCG signals….The PPG signal and/or derivative thereof allow determination (e.g., calculation) of PPG-derived signal features and cardiac timing features such as the PAT and/or the PTT by combining other features from the ECG and/or PCG signals. In block 414, morphological events are detected in the PCG signal, including peaks of S1 and S2 sounds in each cardiac cycle that help to determine cardiac timing signal features such as the PEP and left ventricular ejection time (LVET). [0045]; the PEP may be calculated as a time delay between an R peak of ECG and a peak of S2 sound measured from PCG [0049]; figs 4 & 5).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Ogura in view of Selvaraj such that the method further comprises: capturing, concurrently to the BP cuff system capturing the pulse pressure waveform signal, an electrocardiogram (ECG) of the subject; and indexing the sound waveform signal comprises indexing, based on the ECG, the sound waveform signal to identify the cardiac cycle events, as taught by Selvaraj, because capturing an ECG would provide more information relating to cardiac cycle events and there is a correlation between ECG and heart sounds. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ogura (US Patent Pub. No. 20040064056).
Regarding Claim 7, Ogura discloses the invention as discussed above in claim 1. Ogura further discloses filtering the pulse pressure waveform signal to extract sound components associated with the opening or closing of the heart valve comprises filtering the pulse pressure waveform signal to exclude signal components having a frequency below about 18 Hz (Thus, the heart sounds can be detected at the upper arm 14 by extracting, from the pressure-pulse-wave signal SM, a signal having frequencies in the frequency band generally had by heart sounds. [0043]) because as evidenced by Debbal (Analysis of the Four Heart Sounds…) and Oktivasari et al. (A Real-Time Heart Rate Signal Detection…), “cardiac sounds S1 and S2... are located in the low-frequency range, approximately between 10 Hz and 300 Hz” (pg. 2, Introduction, para. 5, Debbal) and “normal heart sounds have a frequency range between 20 Hz to 200 Hz” (pg. 1, Introduction, para. 1, Oktivasari). Therefore, Ogura discloses filtering the pulse pressure waveform signal to exclude signal components having a frequency below about 18 Hz because the lower end of the frequency band generally had by heart sounds is between 10 Hz and 20 Hz.
In the alternative, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Ogura, through routine optimization, such that filtering the pulse pressure waveform signal to extract sound components associated with the opening or closing of the heart valve comprises filtering the pulse pressure waveform signal to exclude signal components having a frequency below about 18 Hz, because the lower end of the frequency band generally had by heart sounds is between 10 Hz and 20 Hz. "[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." See MPEP 2144.05 and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 8, Ogura discloses the invention as discussed above in claim 7. filtering the pulse pressure waveform signal to extract sound components associated with the opening or closing of the heart valve further comprises filtering the pulse pressure waveform signal to exclude signal components having a frequency above about 250 Hz (Thus, the heart sounds can be detected at the upper arm 14 by extracting, from the pressure-pulse-wave signal SM, a signal having frequencies in the frequency band generally had by heart sounds. [0043]) because as evidenced by Debbal (Analysis of the Four Heart Sounds…) and Oktivasari et al. (A Real-Time Heart Rate Signal Detection…), “cardiac sounds S1 and S2... are located in the low-frequency range, approximately between 10 Hz and 300 Hz” (pg. 2, Introduction, para. 5, Debbal) and “normal heart sounds have a frequency range between 20 Hz to 200 Hz” (pg. 1, Introduction, para. 1, Oktivasari). Therefore, Ogura discloses filtering the pulse pressure waveform signal to exclude signal components having a frequency above about 250 Hz because the higher end of the frequency band generally had by heart sounds is between 200 Hz and 300 Hz.
In the alternative, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Ogura, through routine optimization, such that filtering the pulse pressure waveform signal to extract sound components associated with the opening or closing of the heart valve comprises filtering the pulse pressure waveform signal to exclude signal components having a frequency above about 200 Hz, because the higher end of the frequency band generally had by heart sounds is between 200 Hz and 300 Hz. "[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." See MPEP 2144.05 and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ogura (US Patent Pub. No. 20040064056) as applied to claim 1 above, and further in view of An et al. (US Patent Pub. 20200289057) hereinafter An.
Regarding Claim 9, Ogura discloses the invention as discussed above in claim 1. Ogura fails to disclose analyzing the sound waveform signal to identify characteristics of the heart comprises: analyzing a first component of the sound waveform signal associated with opening of the heart valve; or analyzing a second component of the sound waveform signal associated with closing of the heart valve.
However, An teaches analyzing ta sound waveform signal to identify characteristics of a heart comprises: analyzing a first component of the sound waveform signal associated with opening of the heart valve (The HS metric circuit 222 may compute an ensemble average of the filtered HS signal over multiple cardiac cycles, or over a specified time period, and detect one or more HS components, including a first (S1) heart sound, a second (S2) heart sound, a third (S3) heart sound, or a fourth (S4) heart sound using respective time windows. [0067]; The S1 intensity 331 may include a first component corresponding to mitral valve closure and a second component corresponding to tricuspid valve closure. [0072]; fig 3; Examiner notes mitral valve closure coincides with the aortic valve opening);
or analyzing a second component of the sound waveform signal associated with closing of the heart valve (The HS metric circuit 222 may compute an ensemble average of the filtered HS signal over multiple cardiac cycles, or over a specified time period, and detect one or more HS components, including a first (S1) heart sound, a second (S2) heart sound, a third (S3) heart sound, or a fourth (S4) heart sound using respective time windows. [0067]; S2 is produced by closure of the aortic and pulmonary valves, and marks the beginning of diastole. [0042]).
An is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Ogura such that analyzing the sound waveform signal to identify characteristics of the heart comprises: analyzing a first component of the sound waveform signal associated with opening of the heart valve; or analyzing a second component of the sound waveform signal associated with closing of the heart valve, as taught by An, because S1-S2 are well-understood, routine, and conventional sound components associated with the opening and closing of valves in the art.
Regarding Claim 10, Ogura in view of An teaches the invention as discussed above in claim 9. Ogura in view of An fails to teach analyzing the sound waveform signal to identify characteristics of the heart comprises measuring a stiffness of the heart valve based on an amplitude of the first component or the second component of the sound waveform signal during one or more cardiac cycles.
However, An teaches analyzing a sound waveform signal to identify characteristics of a heart comprises measuring a stiffness of the heart valve based on an amplitude of a first component or a second component of the sound waveform signal during one or more cardiac cycles (The valvular disease risk stratifier circuit 524 can identify patients at risk of valvular heart disease (e.g., aortic stenosis), using the HS metrics generated by the HS metric circuit 522. In an example, the valvular disease risk stratifier circuit 524 can generate a risk indicator of elevated valvular disease risk if the S2 intensity does not satisfy a condition relative to a reference S2 intensity. In another example, a risk indicator of elevated valvular disease risk may be generated in response to an S1 intensity falling below a threshold. [0079]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Ogura in view of An such that analyzing the sound waveform signal to identify characteristics of the heart comprises: measuring a stiffness of the heart valve based on an amplitude of the first component or the second component of the sound waveform signal during one or more cardiac cycles, as taught by An, because it provides information relating to heart health to the subject. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Regarding Claim 11, Ogura in view of An teaches the invention as discussed above in claim 9. Ogura in view of An fails to disclose analyzing the sound waveform signal to identify characteristics of the heart comprises measuring a stiffness of the heart valve based on a presence or absence of the first component or second component of the sound waveform signal during one or more cardiac cycles.
However, An teaches analyzing a sound waveform signal to identify characteristics of a heart comprises measuring a stiffness of the heart valve based on a presence or absence of a first component or a second component of the sound waveform signal during one or more cardiac cycles (The valvular disease risk stratifier circuit 524 can identify patients at risk of valvular heart disease (e.g., aortic stenosis), using the HS metrics generated by the HS metric circuit 522. In an example, the valvular disease risk stratifier circuit 524 can generate a risk indicator of elevated valvular disease risk if the S2 intensity does not satisfy a condition relative to a reference S2 intensity. In another example, a risk indicator of elevated valvular disease risk may be generated in response to an S1 intensity falling below a threshold. [0079]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Ogura in view of An such that analyzing the sound waveform signal to identify characteristics of the heart comprises: measuring a stiffness of the heart valve based on a presence or absence of the first component or the second component of the sound waveform signal during one or more cardiac cycles, as taught by An, because it provides information relating to heart health to the subject. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Regarding Claim 12, Ogura in view of An teaches the invention as discussed above in claim 9. Ogura in view of An fails to teach analyzing the sound waveform signal to identify characteristics of the heart comprises measuring a contraction strength of the heart based on one or more parameters of the first component of the sound waveform signal associated with opening of the heart valve.
However, An teaches analyzing a sound waveform signal to identify characteristics of a heart comprises measuring a contraction strength of the heart based on one or more parameters of a first component of the sound waveform signal associated with opening of the heart valve (An increase in S1 intensity indicates an increase in contractility, and a decrease in left ventricular end-diastolic pressure (LVEDP). [0072]; The valvular disease risk stratifier circuit 524 can identify patients at risk of valvular heart disease (e.g., aortic stenosis), using the HS metrics generated by the HS metric circuit 522. In an example, the valvular disease risk stratifier circuit 524 can generate a risk indicator of elevated valvular disease risk if the S2 intensity does not satisfy a condition relative to a reference S2 intensity. In another example, a risk indicator of elevated valvular disease risk may be generated in response to an S1 intensity falling below a threshold. [0079]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Ogura in view of An such that analyzing the sound waveform signal to identify characteristics of the heart comprises measuring a contraction strength of the heart based on one or more parameters of the first component of the sound waveform signal associated with opening of the heart valve, as taught by An, , because it provides information relating to heart health to the subject. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Regarding Claim 13, Ogura in view of An teaches the invention as discussed above in claim 9. Ogura in view of An fails to teach analyzing the sound waveform signal to identify characteristics of the heart comprises measuring a relaxation strength of the heart based on one or more parameters of the second component of the sound waveform signal associated with closing of the heart valve.
However, An teaches analyzing a sound waveform signal to identify characteristics of a heart comprises measuring a relaxation strength of the heart based on one or more parameters of a second component of the sound waveform signal associated with closing of the heart valve (An increase in S1 intensity indicates an increase in contractility, and a decrease in left ventricular end-diastolic pressure (LVEDP). [0072]; The valvular disease risk stratifier circuit 524 can identify patients at risk of valvular heart disease (e.g., aortic stenosis), using the HS metrics generated by the HS metric circuit 522. In an example, the valvular disease risk stratifier circuit 524 can generate a risk indicator of elevated valvular disease risk if the S2 intensity does not satisfy a condition relative to a reference S2 intensity. In another example, a risk indicator of elevated valvular disease risk may be generated in response to an S1 intensity falling below a threshold. [0079]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Ogura in view of An such that analyzing the sound waveform signal to identify characteristics of the heart comprises measuring a relaxation strength of the heart based on one or more parameters of the second component of the sound waveform signal associated with closing of the heart valve, as taught by An, because it provides information relating to heart health to the subject. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ogura (US Patent Pub. No. 20040064056) as applied to claim 1 above, and further in view of Dargam et al. (US Patent Pub. No. 20210251598) hereinafter Dargam.
Regarding Claim 14, Ogura discloses the invention as discussed above in claim 1. Ogura fails to disclose analyzing the sound waveform signal to identify characteristics of the heart comprises: generating, based on one or more features of the sound waveform signal, using a trained machine learning model, a prediction output indicating whether or not the sound waveform signal is associated with a heart condition.
However, Dargam teaches analyzing ta sound waveform signal to identify characteristics of a heart comprises: generating, based on one or more features of the sound waveform signal, using a trained machine learning model, a prediction output indicating whether or not the sound waveform signal is associated with a heart condition (the methods and devices employ machine learning using artificial neural networks to analyze and quantify sound characteristics [0072]; performing an unsupervised machine learning process to group the at least one heart sound according to a disease stage [0005]; Software was developed that uses machine learning to analyze heart sounds recorded from a commercially available stethoscope and provides an aortic valve health diagnostic. [0084]).
Dargam is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Ogura such that analyzing ta sound waveform signal to identify characteristics of a heart comprises: generating, based on one or more features of the sound waveform signal, using a trained machine learning model, a prediction output indicating whether or not the sound waveform signal is associated with a heart condition, as taught by Dargam, because using machine learning to create prediction models that indicate the presence of an illness from a physiological signal is well-understood, routine, and conventional activity in the art. Furthermore, it would improve the method of Ogura by providing information relating to heart health to the subject. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Stahmann et al. (US Patent Pub. No. 20200008685) discloses a system that analyzes heart sounds and PPG signals to determine an indication of pulse pressure. Song et al. (US Patent Pub. No. 20130289430) discloses a medical device with a treatment delivery device that administers electrical signals when the device detects poor electrical mechanical synchronization. Robinson et al. (US Patent Pub. No. 20170079533) discloses a method that uses blood pressure measurements to assess arterial stiffness. Archdeacon (US Patent No. 10786161) discloses a method in which different cardiac waveforms are analyzed to measure cardiovascular time delay, and the cardiovascular time delay is used to derive at least one of: a cardiovascular health, a cardiovascular fitness level, an arterial compliance, an arterial distensibility, an arterial elasticity, an arterial stiffness, a cardiovascular risk, risk of morbidity, and a risk of mortality.
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/JANKI M BAVA/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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