Office Action 3: Final Rejection (2023-03-21)
Rejection types: 103 - Obviousness

CLAIMS:
AMENDMENTS TO THE CLAIMS

This listing of claims will replace all prior versions and listings of claims in the application.

Listing of Claims:

Claim 1 (Currently Amended): A system comprising:
an insertable cardiac monitor (ICM) comprising:
a housing configured for subcutaneous implantation within a patient, the housing having a length extending from a proximal end of the housing to a distal end of the housing, a width, and a depth, wherein the length is greater than the width and the width is greater than the depth, and
wherein the length is within a range from 40 millimeters (mm) to 60 mm;
a heart sound sensor, wherein the ICM is configured to sense heart sounds of the patient via the heart sound sensor; and
a plurality of electrodes on the housing, wherein the ICM is configured to sense an electrocardiogram (ECG) of the patient via the plurality of electrodes;
a remote computing device; and
processing circuitry of at least one of the insertable cardiac monitor or the remote computing device, the processing circuitry configured to:
periodically determine a respective value for each of a plurality of physiological parameters based on one or more of the heart sounds or the ECG, wherein at least a first physiological parameter of the plurality of physiological parameters is determined based on the heart sounds and at least a second physiological parameter of the plurality of physiological parameters is determined based on the ECG;
output trends of the periodically determined values of the physiological parameters at the remote computing device; and
determine whether to present an indication of a heart failure event based on an analysis of the trends of the periodically determined values of the physiological parameters.

Claim 2 (Canceled).
Claim 3 (Currently Amended): The system of claim 1, wherein the indication of the heart failure event comprises an indication of a risk of the heart failure event.
Claim 4 (Currently Amended): The system of claim 1, wherein to determine whether to present the indication of the heart failure event based on an analysis of the trends of the periodically determined values of the physiological parameters, the processing circuitry is configured to apply respective weights to each of the plurality of physiological parameters.

Claim 5 (Original): The system of claim 1, wherein the plurality of physiological parameters comprise a measurement of an SI heart sound.

Claim 6 (Original): The system of claim 1, wherein the plurality of physiological parameters comprise a measurement of an S3 heart sound.

Claim 7 (Original): The system of claim 1, wherein the plurality of physiological parameters comprise one or more of: a morphological measurement of an S I and/or S2 heart sound, or a presence/frequency of an S3 and/or S4 heart sound.

Claim 8 (Original): The system of claim 1, wherein the plurality of physiological parameters comprise a morphological measurement of an S1 heart sound.

Claim 9 (Original): The system of claim 1, wherein the plurality of physiological parameters comprise a presence/frequency of an S3 heart sound.

Claim 10 (Original): The system of claim 1, wherein the ICM comprises a patient activity sensor configured to sense activity/posture of the patient, and the processing circuitry is configured to periodically determine values of at least one physiological parameter of the plurality of physiological parameters based on the sensed activity/posture.

Claim 11 (Currently Amended): The system of claim 1, wherein the ICM comprises one or more accelerometers , and the processing circuitry is configured to periodically determine values of at least one physiological parameter of the plurality of physiological parameters based on a signal from the one or more accelerometers.

Claim 12 (Currently Amended): The system of claim 1, wherein the processing circuitry is configured to determine whether a change of at least one of the physiological parameters in a period is significantly greater than a variation in the physiological parameter during prior periods, and determine whether to present the indication of the heart failure event based on the determination of whether the change in the period is significantly greater than the variation during the prior periods.

Claim 13 (Currently Amended): The system of claim 1, wherein the processing circuitry is configured to determine whether to present the indication of the heart failure event based on a comparison of a physiological parameter value for a current period to a threshold determined based on physiological parameter values for previous periods.

Claim 14 (Original): The system of claim 1, wherein the plurality of physiological parameters comprises at least one of a heart rate variability parameter or a night heart rate parameter.

Claim 15 (Original): The system of claim 1, wherein the housing defines an elongated rectangular prism comprising a rounded distal end and a rounded proximal end.

Claim 16 (Original): The system of claim 1, wherein the plurality of electrodes comprises a first electrode that is substantially flat and a second electrode that comprises a three-dimensional, curved configuration.

Claim 17 (Original): The system of claim 1, wherein a volume of the ICM is less than 1.5 cubic centimeters.

Claim 18 (Currently Amended): A non-transitory computer-readable storage medium comprising program instructions that, when executed by processing circuitry, cause the processing circuitry to:
periodically determine a respective value for each of a plurality of physiological parameters based on one or more of heart sounds or an electrocardiogram (ECG) sensed by an insertable cardiac monitor (ICM), wherein at least a first physiological parameter of the plurality of physiological parameters is determined based on the heart sounds and at least a second physiological parameter of the plurality of physiological parameters is determined based on the ECG, wherein the ICM comprises:
a housing configured for subcutaneous implantation within a patient, the housing having a length extending from a proximal end of the housing to a distal end of the housing, a width, and a depth, wherein the length is greater than the width and the width is greater than the depth, and
wherein the length is within a range from 40 millimeters (mm) to 60 mm;
a heart sound sensor, wherein the ICM is configured to sense the heart sounds via the heart sound sensor; and
a plurality of electrodes on the housing, wherein the ICM is configured to sense the ECG via the plurality of electrodes;
output trends of the periodically determined values of the physiological parameters at a remote computing device; and
determine whether to present an indication of a heart failure event based on an analysis of the trends of the periodically determined values of the physiological parameters.

Claim 19 (Canceled).

Claim 20 (Currently Amended): The non-transitory computer-readable storage medium of claim 18, wherein the indication of the heart failure event comprises an indication of a risk of the heart failure event.

Claim 21 (Original): The non-transitory computer-readable storage medium of claim 18, wherein the plurality of physiological parameters comprise a measurement of an S1 heart sound.

Claim 22 (Original): The non-transitory computer-readable storage medium of claim 18, wherein the plurality of physiological parameters comprise a measurement of an S3 heart sound.

Claim 23 (Original): The non-transitory computer-readable storage medium of claim 18, wherein the plurality of physiological parameters comprise one or more of: a morphological measurement of an S1 and/or S2 heart sound, or a presence/frequency of an S3 and/or S4 heart sound.

Claim 24 (Original): The non-transitory computer-readable storage medium of claim 18, wherein the plurality of physiological parameters comprise a morphological measurement of an S1 heart sound.

Claim 25 (Original): The non-transitory computer-readable storage medium of claim 18, wherein the plurality of physiological parameters comprise a presence/frequency of an S3 heart sound.

Claim 26 (Original): The non-transitory computer-readable storage medium of claim 18, wherein the ICM comprises a patient activity sensor configured to sense activity/posture of the patient, the method further comprising periodically determining values of at least one physiological parameter of the plurality of physiological parameters based on the sensed activity/posture.

Claim 27 (Currently Amended): An insertable cardiac monitor (ICM) comprising:
a housing configured for subcutaneous implantation within a patient, the housing having a length extending from a proximal end of the housing to a distal end of the housing, a width, and a depth, wherein the length is greater than the width and the width is greater than the depth, wherein the length is within a range from 40 millimeters (mm) to 60 mm;
a heart sound sensor, wherein the ICM is configured to sense heart sounds of the patient via the heart sounds sensor;
a plurality of electrodes on the housing, wherein the ICM is configured to sense an electrocardiogram (ECG) of the patient via the plurality of electrodes; and
communication circuitry within the housing; and
processing circuitry within the housing, the processing circuitry configured to:
cause the communication circuitry to establish one or more telemetry communication sessions with a remote computing device; and
cause the communication circuitry to, during the one or more telemetry communication sessions, communicate values of a plurality of physiological parameters periodically determined based at least in part on one or more of the heart sounds or the ECG to the remote computing device, wherein at least a first physiological parameter of the plurality of physiological parameters is determined based on the heart sounds and at least a second physiological parameter of the plurality of physiological parameters is determined based on the ECG, wherein the remote computing device is configured to output trends of the periodically determined values of the physiological parameters and is further configured to determine whether to present an indication of a heart failure event based on an analysis of the trends of the periodically determined values of the physiological parameters.

Claim 28 (Original): The insertable cardiac monitor (ICM) of claim 27, wherein the plurality of physiological parameters comprise at least one of a measurement of an S1 heart sound or a measurement of an S3 heart sound.

Claim 29 (Currently Amended): A system comprising:
an insertable cardiac monitor (ICM) comprising:
a housing configured for subcutaneous implantation within a patient, the housing having a length extending from a proximal end of the housing to a distal end of the housing, a width, and a depth, wherein the length is greater than the width and the width is greater than the depth, and
wherein the length is within a range from 40 millimeters (mm) to 60 mm;
a heart sound sensor, wherein the ICM is configured to sense heart sounds of the patient via the heart sound sensor; and
a plurality of electrodes on the housing, wherein the ICM is configured to sense an electrocardiogram (ECG) of the patient via the plurality of electrodes;
means for periodically determining a respective value for each of a plurality of physiological parameters based on one or more of the heart sounds or the ECG, wherein at least a first physiological parameter of the plurality of physiological parameters is determined based on the heart sounds and at least a second physiological parameter of the plurality of physiological parameters is determined based on the ECG;
means for outputting trends of the periodically determined values of the physiological parameters at the remote computing device; and
means for determining whether to present an indication of a heart failure event based on an analysis of the trends of the periodically determined values of the physiological parameters.

Claim 30 (Original): The system of claim 29, wherein the plurality of physiological parameters comprise at least one of a measurement of an Si heart sound or a measurement of an S3 heart sound.

Claim 31 (New): The system of claim 1, wherein the ICM is configured to sense the ECG via a proximal electrode of the plurality of electrodes at the proximal end and a distal electrode of the plurality of electrodes at the distal end.
Claim 32 (New): The ICM of claim 27, wherein the ICM is configured to sense the ECG via a proximal electrode of the plurality of electrodes at the proximal end and a distal electrode of the plurality of electrodes at the distal end.
2 3 4 5 6 7 8 9

OFFICE ACTION:
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 .
Response to Arguments
Applicant’s arguments, see Pages 10-13, filed 2/14/2023, with respect to the rejection(s) of claim(s) 1, 3-18, and 20-30 under USC 103 have been fully considered and are persuasive.  Therefore, the rejection has been withdrawn.  However, upon further consideration, a new ground(s) of rejection is made in view of Stahmann (US 2005/0115561 A1) in view of McCabe (US 2010/0121399 A1).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-16, 18, and 20-32 are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann (US 2005/0115561 A1) (cited previously) in view of McCabe (US 2010/0121399 A1), further in view of Zhang (US 2011/009760 A1).
Regarding claim 1, 18, 27, and 29, Stahmann discloses a system comprising: an insertable cardiac monitor (ICM) (eg. Fig 4A, 400) comprising: a housing configured for subcutaneous implantation within a patient (eg. Fig. 4A, housing 401), the housing having a length, a width, and a depth, wherein the length is greater than the width and the width is greater than the depth, and wherein the length is within a range from 40 millimeters (mm) to 60 mm (eg. Para. 266); a heart sound sensor (eg. Para. 219, 231, 1486), wherein (in multiple embodiments) the ICM is configured to sense heart sounds of the patient via the heart sound sensor (eg. Para. 219, 231, 1486); wherein the ICM is configured to sense an electrocardiogram (ECG) of the patient via the plurality of electrodes (eg. Para. 217, 376); a remote computing device (eg. Para. 24, 177); and processing circuitry of at least one of the insertable cardiac monitor or the remote computing device (eg. Para. 24), the processing circuitry configured to: periodically determine a respective value for each of a plurality of physiological parameters based on one or more of the heart sounds or the ECG (eg. Para. 231, 261); output trends of the periodically determined values of the physiological parameters at the remote computing device; and determine whether to present an indication of a cardiac event based on an analysis of the trends of the periodically determined values of the physiological parameters (eg. Para. 199, 972, 1520). While Stahmann discloses a housing (eg. Fig. 4A 401 housing), but does not disclose multiple electrodes on the housing and determining a heart failure deterioration based on trends and parameters based on heart sounds and ECG.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the embodiments of Stahmann to incorporate heart sound sensors to better improve the diagnoses of diseases by providing additional parameters for analysis (eg. Para. 1486 and 1516-1522).
McCabe teaches an implantable medical device that has a housing (eg. Fig. 17, 1788) with leadless ECG electrodes on the housing of the device (eg. Fig. 17, 1790).
It would have been obvious to before the effective filing date of the claimed invention to have modified the implant as disclosed by Stahmann (eg. Fig. 4A) to have leadless ECG electrodes as taught by McCabe (eg. Fig. 17, electrodes 1790) for the expected outcome of making the implant more compact for ease of use and implantation.
Zhang teaches a medical monitoring device (eg. Para. 34) that detects deterioration in a patient’s heart failure status by comparing changes in heart sounds (eg. Para. 126) and ecg data (eg. Para. 47 and 127) past a certain threshold (eg. Para. 61).
It would have been obvious before the effective filing date of the claimed invention to combine the invention of Stahmann and McCabe with the deterioration thresholds for physiological parameters as taught by Zhang for the expected outcome of improving detection of heart failure and deterioration associated with it during a period of time.
Regarding claim 3 and 20, the combined invention of Stahmann, McCabe, and Zhang discloses the indication of the cardiac event comprises an indication of a risk of the cardiac event (eg. Para. 1409-1410).
Regarding claim 4, the combined invention of Stahmann, McCabe, and Zhang discloses to determine whether to present the indication of the cardiac event based on an analysis of the trends of the periodically-determined values of the 1PATENT CO00013179US02CON / 1111-511US03 physiological parameters, the processing circuitry is configured to apply respective weights to each of the plurality of physiological parameters (eg. Para. 411-412, 559-562).
Regarding claim 5 and 21, the combined invention of Stahmann, McCabe, and Zhang discloses the plurality of physiological parameters comprise a measurement of an S1 heart sound (eg. Para. 219, 1520).
Regarding claim 6 and 22, the combined invention of Stahmann, McCabe, and Zhang discloses the plurality of physiological parameters comprise a measurement of an S3 heart sound (eg. Para. 1273, 1502, 1520).
Regarding claim 7, 23, 28, and 30, the combined invention of Stahmann, McCabe, and Zhang discloses the plurality of physiological parameters comprise one or more of a morphological measurement of an S1 and/or S2 heart sound, or a presence/frequency of an S3 and/or S4 heart sound (eg. Para. 1520).
Regarding claim 8 and 24, the combined invention of Stahmann, McCabe, and Zhang discloses the plurality of physiological parameters comprise a morphological measurement of an S1 heart sound (eg. Para. 1520).
Regarding claim 9 and 25, the combined invention of Stahmann, McCabe, and Zhang discloses the plurality of physiological parameters comprise a presence/frequency of an S3 heart sound (eg. Para. 1520).
Regarding claim 10 and 26, the combined invention of Stahmann, McCabe, and Zhang discloses the ICM comprises a patient activity sensor configured to sense activity/posture of the patient, and the processing circuitry is configured to periodically determine values of at least one physiological parameter of the plurality of physiological parameters based on the sensed activity/posture (Eg. Para. 219).
Regarding claim 11, the combined invention of Stahmann, McCabe, and Zhang discloses the ICM comprises one or more accelerometers configured to generate, and the processing circuitry is configured to periodically determine values of at least one physiological parameter of the plurality of physiological parameters based on a signal from the one or more accelerometers (eg. Para. 219).
Regarding claim 12, the combined invention of Stahmann, McCabe, and Zhang discloses the processing circuitry is configured to determine whether a change of at least one of the physiological parameters in a period is significantly 2PATENTgreater than a variation in the physiological parameter during prior periods, and determine whether to present the indication of the cardiac event based on the determination (eg. Para. 109, Fig. 62A-N, Para. 221,Table 2, 288, 295) of whether the change in the period is significantly greater than the variation during the prior periods (eg. Zhang, Para. 61, at least a threshold level of deterioration, if there is no significance, then the threshold is not crossed).
Regarding claim 13, the combined invention of Stahmann, McCabe, and Zhang discloses the processing circuitry is configured to determine whether to present the indication of the cardiac event based on a comparison of a physiological parameter value for a current period to a threshold determined based on physiological parameter values for previous periods (Eg. Para. 677 and 693).
Regarding claim 14, the combined invention of Stahmann, McCabe, and Zhang discloses the plurality of physiological parameters comprises at least one of a heart rate variability parameter or a night heart rate parameter (eg. Table 2-3, Para. 1497).
Regarding claim 15, the combined invention of Stahmann, McCabe, and Zhang discloses the housing defines an elongated rectangular prism comprising a rounded distal end and a rounded proximal end (eg. Fig. 4A rounded edges on each side).
Regarding claim 16, the combined invention of Stahmann, McCabe, and Zhang discloses plurality of electrodes comprises a first electrode that is substantially flat and a second electrode that comprises a three-dimensional, curved configuration (eg. Para. 235-239).
Regarding claims 31 and 32, the combined invention of Stahmann, McCabe, and Zhang discloses a proximal electrode of the plurality of electrodes at the proximal end and a distal exlectrode of the plurality of electrodes at the distal end (eg. McCabe, Fig. 17, electrodes 1790 electrodes on opposite ends of the device).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Stahmann (US 2005/0115561 A1) in view of McCabe (US 2010/0121399 A1), further in view of Zhang (US 2011/009760 A1), further in view of Lee (US 2012/0283705 A1) (cited previously).
Regarding claim 17, the combined invention of Stahmann, McCabe, and Zhang discloses the invention of claim 1, but does not disclose a volume of the ICM is less than 1.5 cubic centimeters.
Lee discloses an IMD that utilizes sensors for detecting heart sounds with a housing that has a volume with dimensions of 25 mm x 1 mm x 3 mm, which is about 0.075 cubic cm (eg. Para. 57 and 117).
It would have been obvious to have modified the invention of Stahman to scale down the size of the device as taught by Lee to allow for easier implantation and less tissue displacement (eg. Lee, Para. 57).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action.  Accordingly, THIS ACTION IS MADE FINAL.  See MPEP § 706.07(a).  Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action.  In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action.  In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.

APPLICANT REBUTTAL: REMARKS
This Amendment is responsive to the Office Action dated March 21, 2023. Applicant has amended claims 1, 7, 18, 23, and 26-30, and canceled claims 6, 9, 22, and 25. Claims 1, 3-5, 7, 8, 10-18, 20, 21, 23, 24, and 26-32 are pending upon entry of this Amendment.
Claim Re
j
ection Under 35 U.S.C.
&
The Office Action rejected the previously pending claims under 35 U.S.C. § 103 as follows:
" Claims 1, 3-6, 18, and 20-32 were rejected as allegedly being unpatentable over U.S.
Publication No. 2005/0115561 Al by Stahmann et al. (hereinafter, "Stahmann") in view
of U.S. Publication No. 2010/0121399 Al by McCabe et al. (hereinafter, "McCabe"), further in view of U.S. Publication No. 2011/009760 Al by Zhang et al. (hereinafter,
"Zhang"); and
" Claim 17 was rejected as allegedly being unpatentable over Stahmann in view of MCabe,
further in view of Zhang, further in view of U.S. Patent Application Publication No.
2012/0283705 Al by Lee et al. (hereinafter, "Lee").
Applicant respectfully traverses the rejections to the extent the rejections may be
considered applicable to the claims as amended. The applied references, alone or in any proper combination, fail to disclose or suggest the features defined by Applicant's amended claims, and there would have been no apparent reason that would have caused one of ordinary skill in the art to modify the applied references to arrive at the claimed features.
For example, the applied references fail to disclose or suggest "processing circuitry
configured to: periodically determine a respective value for each of a plurality of physiological parameters based on one or more of [] heart sounds or [an] ECG, wherein at least a first physiological parameter of the plurality of physiological parameters is determined based on the heart sounds and at least a second physiological parameter of the plurality of physiological parameters is determined based on the ECG, wherein the first physiological parameter comprises a frequency of occurrence of an S3 heart sound; ... and determine whether to present an indication of a heart failure event based on an analysis of the trends of the periodically determined values of the physiological parameters," as recited by amended independent claim 1, or the similar recitations of the other amended independent claims.
In rejecting previously pending claims that recited an S3 heart sound (e.g., claims 6, 7, 9, 22, 23, 25, 28, and 30), the Office Action cited paragraphs [1273], [1502], and [1520] of Stahmann. The paragraphs of Stahmann cited in the Office Action do not even relate to heart sounds, much less an S3 heart sound. Paragraph [1265] of Stahmann mentions S3 heart sounds in a listing of "[a] representative set of symptoms and/or physiological changes associated with non-rhythm pulmonary diseases ... ." Paragraph [1494] of Stahmann discloses S3 in a list of "[e]xamples of data acquired during non-sleep that may aid in nocturnal therapy and diagnosis. . ." Paragraph [1512] of Stahmann discusses the S3 heart sound, and states "[a]fter age 40, it almost always indicates the failing heart in congestive heart failure."
However, none of this description from Stahmann discloses or suggests "processing circuitry configured to: periodically determine a respective value for each of a plurality of physiological parameters based on one or more of the heart sounds or the ECG, wherein at least a first physiological parameter of the plurality of physiological parameters is determined based on the heart sounds and at least a second physiological parameter of the plurality of physiological parameters is determined based on the ECG, wherein the first physiological parameter comprises a frequency of occurrence of an S3 heart sound; ... and determine whether to present an indication of a heart failure event based on an analysis of the trends of the periodically determined values of the physiological parameters," as recited by amended independent claim 1, or the similar recitations of the other amended independent claims. Nor do the other cited references disclose or suggest these features of the amended independent claims. For at least this reason, independent claims 1, 18, 27, and 29 are patentable over the cited references. The dependent claims incorporate the requirements of the respective independent claims.1 Accordingly, the dependent claims are likewise patentable.
For at least these reasons, the Office has failed to establish aprimafacie case for non- patentability of Applicant's claims 1, 3-5, 7, 8, 10-18, 20, 21, 23, 24, and 26-32 under 35 U.S.C. § 103. Applicant therefore respectfully requests reconsideration and withdrawal of this rejection.
1 35 U.S.C. § 112(d).
CONCLUSION

NEXT OFFICE ACTION: The Corrected Office Action Supercedes the previous one
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 5/17/2023 has been entered.
Response to Arguments
Applicant’s arguments, see Pages 10-12, filed 5/17/2023, with respect to the rejection(s) of claim(s) 1, 3-5, 7-8, 10-18, 20-21, 23-24, 26-32 under USC 103 have been fully considered and are persuasive.  Therefore, the rejection has been withdrawn.  However, upon further consideration, a new ground(s) of rejection is made in view of Stahmann (US 2005/0115561 A1), in view of McCabe (US 2010/0121399 A1), further in view of Zhang (US 2011/009760 A1), further in view of Siejko (US 2005/0148896 A1).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-5, 7-8, 10-16, 18, 20-21, and 23-24, 26-32 are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann (US 2005/0115561 A1) (cited previously) in view of McCabe (US 2010/0121399 A1), further in view of Siejko (US 2005/0148896 A1) further in view of Zhang (US 2011/009760 A1).
Regarding claim 1, 18, 27, and 29, Stahmann discloses a system comprising: an insertable cardiac monitor (ICM) (eg. Fig 4A, 400) comprising: a housing configured for subcutaneous implantation within a patient (eg. Fig. 4A, housing 401), the housing having a length, a width, and a depth, wherein the length is greater than the width and the width is greater than the depth, and wherein the length is within a range from 40 millimeters (mm) to 60 mm (eg. Para. 266); a heart sound sensor (eg. Para. 219, 231, 1486), wherein (in multiple embodiments) the ICM is configured to sense heart sounds of the patient via the heart sound sensor (eg. Para. 219, 231, 1486); wherein the ICM is configured to sense an electrocardiogram (ECG) of the patient via the plurality of electrodes (eg. Para. 217, 376); a remote computing device (eg. Para. 24, 177); and processing circuitry of at least one of the insertable cardiac monitor or the remote computing device (eg. Para. 24), the processing circuitry configured to: periodically determine a respective value for each of a plurality of physiological parameters based on one or more of the heart sounds or the ECG (eg. Para. 231, 261); output trends of the periodically determined values of the physiological parameters at the remote computing device (eg. Para. 199 stored in separate device for storage and further processing/trending/etc.); and determine whether to present an indication of a cardiac event based on an analysis of the trends of the periodically determined values of the physiological parameters (eg. Para. 199, 972, 1520). While Stahmann discloses a housing (eg. Fig. 4A 401 housing), but does not disclose multiple electrodes on the housing and determining a heart failure deterioration based on trends and parameters based on heart sounds and ECG and the firs physiological parameter comprises a frequency of occurrence of an S3 heart sound.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the embodiments of Stahmann to incorporate heart sound sensors to better improve the diagnoses of diseases by providing additional parameters for analysis (eg. Para. 1486 and 1516-1522).
McCabe teaches an implantable medical device that has a housing (eg. Fig. 17, 1788) with leadless ECG electrodes on the housing of the device (eg. Fig. 17, 1790).
It would have been obvious to before the effective filing date of the claimed invention to have modified the implant as disclosed by Stahmann (eg. Fig. 4A) to have leadless ECG electrodes as taught by McCabe (eg. Fig. 17, electrodes 1790) for the expected outcome of making the implant more compact for ease of use and implantation.
Zhang teaches a medical monitoring device (eg. Para. 34) that detects deterioration in a patient’s heart failure status by comparing changes in heart sounds (eg. Para. 126) and ecg data (eg. Para. 47 and 127) past a certain threshold (eg. Para. 61).
It would have been obvious before the effective filing date of the claimed invention to combine the invention of Stahmann and McCabe with the deterioration thresholds for physiological parameters as taught by Zhang for the expected outcome of improving detection of heart failure and deterioration associated with it during a period of time.
Siejko teaches a cardiac rhythm management system that includes a heart sound detector for the detection of S3 heart sounds where the an S3 index is produced by counting the number of S3 beats to determine to the total number of heart beats and presented as a percentage (eg. Abstract, Para. 5 and 49, Fig. 4, step 440).
It would have been obvious before the effective filing date of the claimed invention to combine the invention of Stahmann, McCabe, and Zhang to use S3 heart sound trends/indices as taught by Siejko as an additional indication of heart failure since S3 is related to ventricular stiffness and degree of strictive filling which indicate abnormal cardiac conditions (eg. Siejko, Para. 5).
Regarding claim 3 and 20, the combined invention of Stahmann, McCabe, Zhang, and Siejko discloses the indication of the cardiac event comprises an indication of a risk of the cardiac event (eg. Para. 1409-1410).
Regarding claim 4, the combined invention of Stahmann, McCabe, Zhang, and Siejko discloses to determine whether to present the indication of the cardiac event based on an analysis of the trends of the periodically-determined values of the  CO00013179US02CON / 1111-511US03 physiological parameters, the processing circuitry is configured to apply respective weights to each of the plurality of physiological parameters (eg. Stahmann, Para. 411-412, 559-562).
Regarding claim 5 and 21, the combined invention of Stahmann, McCabe, Zhang, and Siejko discloses the plurality of physiological parameters comprise a measurement of an S1 heart sound (eg. Stahmann, Para. 219, 1520).
Regarding claim 7, 23, 28, and 30, the combined invention of Stahmann, McCabe, Zhang, and Siejko discloses the plurality of physiological parameters comprise one or more of a morphological measurement of an S1 and/or S2 heart sound, or a presence/frequency of an S3 and/or S4 heart sound (eg. Para. 1520).
Regarding claim 8 and 24, the combined invention of Stahmann, McCabe, Zhang, and Siejko discloses the plurality of physiological parameters comprise a morphological measurement of an S1 heart sound (eg. Para. 1520).
Regarding claim 10 and 26, the combined invention of Stahmann, McCabe, Zhang, and Siejko discloses the ICM comprises a patient activity sensor configured to sense activity/posture of the patient, and the processing circuitry is configured to periodically determine values of at least one physiological parameter of the plurality of physiological parameters based on the sensed activity/posture (Eg. Para. 219).
Regarding claim 11, the combined invention of Stahmann, McCabe, Zhang, and Siejko discloses the ICM comprises one or more accelerometers configured to generate, and the processing circuitry is configured to periodically determine values of at least one physiological parameter of the plurality of physiological parameters based on a signal from the one or more accelerometers (eg. Stahmann, Para. 219).
Regarding claim 12, the combined invention of Stahmann, McCabe, Zhang, and Siejko discloses the processing circuitry is configured to determine whether a change of at least one of the physiological parameters in a period is significantly 2PATENTgreater than a variation in the physiological parameter during prior periods, and determine whether to present the indication of the cardiac event based on the determination (eg. Stahmann, Para. 109, Fig. 62A-N, Para. 221, Table 2, 288, 295) of whether the change in the period is significantly greater than the variation during the prior periods (eg. Zhang, Para. 61, at least a threshold level of deterioration, if there is no significance, then the threshold is not crossed).
Regarding claim 13, the combined invention of Stahmann, McCabe, Zhang, and Siejko discloses the processing circuitry is configured to determine whether to present the indication of the cardiac event based on a comparison of a physiological parameter value for a current period to a threshold determined based on physiological parameter values for previous periods (eg. Stahmann, Para. 677 and 693).
Regarding claim 14, the combined invention of Stahmann, McCabe, Zhang, and Siejko discloses the plurality of physiological parameters comprises at least one of a heart rate variability parameter or a night heart rate parameter (eg. Stahmann, Table 2-3, Para. 1497).
Regarding claim 15, the combined invention of Stahmann, McCabe, Zhang, and Siejko discloses the housing defines an elongated rectangular prism comprising a rounded distal end and a rounded proximal end (eg. Stahmann, Fig. 4A rounded edges on each side).
Regarding claim 16, the combined invention of Stahmann, McCabe, Zhang, and Siejko discloses plurality of electrodes comprises a first electrode that is substantially flat and a second electrode that comprises a three-dimensional, curved configuration (eg. Stahmann, Para. 235-239).
Regarding claims 31 and 32, the combined invention of Stahmann, McCabe, Zhang, and Siejko discloses a proximal electrode of the plurality of electrodes at the proximal end and a distal electrode of the plurality of electrodes at the distal end (eg. McCabe, Fig. 17, electrodes 1790 electrodes on opposite ends of the device).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Stahmann (US 2005/0115561 A1) in view of McCabe (US 2010/0121399 A1), further in view of Zhang (US 2011/009760 A1), further in view of Siejko (US 2005/0148896 A1), further in view of Lee (US 2012/0283705 A1) (cited previously).
Regarding claim 17, the combined invention of Stahmann, McCabe, Zhang, and Siejko discloses the invention of claim 1, but does not disclose a volume of the ICM is less than 1.5 cubic centimeters.
Lee discloses an IMD that utilizes sensors for detecting heart sounds with a housing that has a volume with dimensions of 25 mm x 1 mm x 3 mm, which is about 0.075 cubic cm (eg. Para. 57 and 117).
It would have been obvious to have modified the invention of Stahman to scale down the size of the device as taught by Lee to allow for easier implantation and less tissue displacement (eg. Lee, Para. 57).
Conclusion

CITED REFERENCE SUMMARIES: Ref US20050148896A1: Claims:
A heart sound detection system, comprising: a cardiac signal input to receive a cardiac signal indicative of ventricular events; an acoustic signal input to receive an acoustic signal indicative of at least second heart sounds (S 2 ) and third heart sounds (S 3 ); and a heart sound detector coupled to the cardiac signal input and the acoustic signal input, the heart sound detector including: an S 2 window generator to generate an S 2 window after a first predetermined delay starting with each of the ventricular events; an S 2 detector to detect S 2 during the S 2 windows; an S 3 window generator, coupled to the S 2 detector, to generate an S 3 window after a second predetermined delay starting with each of the detected S 2 ; and an S 3 detector to detect S 3 during the S 3 windows.
a cardiac signal input to receive a cardiac signal indicative of ventricular events;
an acoustic signal input to receive an acoustic signal indicative of at least second heart sounds (S 2 ) and third heart sounds (S 3 ); and
a heart sound detector coupled to the cardiac signal input and the acoustic signal input, the heart sound detector including: an S 2 window generator to generate an S 2 window after a first predetermined delay starting with each of the ventricular events; an S 2 detector to detect S 2 during the S 2 windows; an S 3 window generator, coupled to the S 2 detector, to generate an S 3 window after a second predetermined delay starting with each of the detected S 2 ; and an S 3 detector to detect S 3 during the S 3 windows.
an S 2 window generator to generate an S 2 window after a first predetermined delay starting with each of the ventricular events;
an S 2 detector to detect S 2 during the S 2 windows;
an S 3 window generator, coupled to the S 2 detector, to generate an S 3 window after a second predetermined delay starting with each of the detected S 2 ; and
an S 3 detector to detect S 3 during the S 3 windows.
The system of claim 1 , further comprising an envelope detector coupled between the acoustic signal input and the heart sound detector, the envelope detector including a rectifier and a low-pass filter coupled to the rectifier.
The system of claim 2 , further comprising an averaging circuit to improve a signal-to-noise ratio of the acoustic signal by ensemble averaging.
The system of claim 3 , wherein the averaging circuit is adapted to align segments of the acoustic signal using the ventricular events.
The system of claim 3 , wherein the averaging circuit is adapted to align segments of the acoustic signal using occurrences of the S 2 detection.
The system of claim 1 , further comprising an S 1 detector to detect first heart sounds (S 1 ).
The system of claim 6 , further comprising a measurement module, coupled to the heart sound detector, to produce parameters related to one or more of S 1 , S 2 , and S 3 .
The system of claim 7 , wherein the measurement module comprises an amplitude detector to detect one or more of an S 1 amplitude, an S 2 amplitude, and an S 3 amplitude.
The system of claim 8 , wherein the S 2 detector comprises an S 2 comparator to compare the acoustic signal to a predetermined S 2 threshold.
The system of claim 9 , wherein the S 2 detector further comprises an S 2 threshold generator coupled to the S 2 comparator, the S 2 threshold generator adapted to determine the S 2 threshold based on the detected S 1 and S 2 amplitudes.
The system of claim 9 , wherein the S 3 detector comprises an S 3 comparator to compare the acoustic signal to a predetermined S 3 threshold.
The system of claim 11 , wherein the S 3 detector further comprises an S 3 threshold generator coupled to the S 3 comparator, the S 3 threshold generator adapted to dynamically adjust the S 3 threshold based on at least one of the detected S 1 and S 2 amplitudes and a percentage of the detected S 2 amplitude.
The system of claim 11 , wherein the measurement module further comprises an energy detector to detect one or more of an energy associated with S 1 , an energy associated with S 2 , an energy associated with S 3 , a total acoustic energy during an cardiac cycle, and a total acoustic energy during systole of the cardiac cycle.
The system of claim 13 , wherein the S 3 detector further comprises an S 3 threshold generator coupled to the S 3 comparator, the S 3 threshold generator adapted to dynamically adjust the S 3 threshold based on at least one of: the total acoustic energy during cardiac cycle; a mean and a standard deviation of the total acoustic energy during cardiac cycle; the total acoustic energy during systole of the cardiac cycle; a mean and a standard deviation of the total acoustic energy during systole of the cardiac cycle; and a temporal average of one or more of the S 1 amplitude, the S 2 amplitude, the total acoustic energy in one cardiac cycle.
the total acoustic energy during cardiac cycle;
a mean and a standard deviation of the total acoustic energy during cardiac cycle;
the total acoustic energy during systole of the cardiac cycle;
a mean and a standard deviation of the total acoustic energy during systole of the cardiac cycle; and
a temporal average of one or more of the S 1 amplitude, the S 2 amplitude, the total acoustic energy in one cardiac cycle.
The system of claim 11 , wherein the S 3 detector further comprises an S 3 threshold generator coupled to the S 3 comparator, the S 3 threshold generator adapted to dynamically adjust the S 3 threshold based on an estimated background sound level (Î¼ B ) measured during a predetermined period between an occurrence of S 1 and an adjacent occurrence of S 2 .
The system of claim 15 , wherein the S 3 threshold generator comprises an S 3 threshold calculator to calculate the S 3 threshold as Î¼ B *K, where K is an adjustable multiplier.
The system of claim 16 , further comprising a heart rate detector, couple to the cardiac signal input, to detect a heart rate, and wherein the S 3 threshold generator comprises a scaling module to scale the predetermined period between the occurrence of S 1 and the adjacent occurrence of S 2 for the heart rate.
A heart sound detection method, comprising: receiving a cardiac signal indicative of ventricular events; receiving an acoustic signal indicative of at least second heart sounds (S 2 ) and third heart sounds (S 3 ); detecting S 2 by comparing the acoustic signal to an S 2 threshold; generating an S 3 window after a first predetermined delay starting with each of the detected S 2 ; and detecting S 3 during the S 3 windows by comparing the acoustic signal to a dynamically adjustable S 3 threshold.
receiving a cardiac signal indicative of ventricular events;
receiving an acoustic signal indicative of at least second heart sounds (S 2 ) and third heart sounds (S 3 );
detecting S 2 by comparing the acoustic signal to an S 2 threshold;
generating an S 3 window after a first predetermined delay starting with each of the detected S 2 ; and
detecting S 3 during the S 3 windows by comparing the acoustic signal to a dynamically adjustable S 3 threshold.
The method of claim 18 , wherein detecting S 2 comprises: detecting ventricular events from the cardiac signal; generating an S 2 window after a second predetermined delay upon each detection of the ventricular events; and detecting S 2 during the S 2 windows by comparing the acoustic signal to the S 2 threshold.
detecting ventricular events from the cardiac signal;
generating an S 2 window after a second predetermined delay upon each detection of the ventricular events; and
detecting S 2 during the S 2 windows by comparing the acoustic signal to the S 2 threshold.
The method of claim 19 , further comprising improving a signal-to-noise ratio of the acoustic signal by ensemble averaging.
The method of claim 20 , wherein the ensemble averaging comprises aligning segments of the acoustic signal using the ventricular events.
The method of claim 20 , wherein the ensemble averaging comprises aligning segments of the acoustic signal using occurrences of the S 2 detection.
The method of claim 18 , further comprising detecting S 1 by comparing the acoustic signal to an S 1 threshold.
The method of claim 23 , further comprising detecting one or more of an S 1 amplitude, an S 2 amplitude, and an S 3 amplitude.
The method of claim 24 , further comprising determining the S 3 threshold based on one or more of the S 1 amplitude and the S 2 amplitude.
The method of claim 25 , further comprising determining the S 3 threshold as a percentage of the S 2 amplitude.
The method of claim 24 , further comprising determining one or more of an energy associated with S 1 , an energy associated with S 2 , an energy associated with S 3 , a total acoustic energy during a cardiac cycle, and a total acoustic energy during systole of the cardiac cycle.
The method of claim 27 , further comprising determining the S 3 threshold based on the total acoustic energy during the cardiac cycle.
The method of claim 28 , further comprising determining the S 3 threshold based on at least a mean and a standard deviation of the total acoustic energy in the cardiac cycle.
The method of claim 27 , further comprising determining the S 3 threshold based on the total acoustic energy during the systole of the cardiac cycle.
The method of claim 30 , further comprising determining the S 3 threshold based on at least a mean and a standard deviation of the total acoustic energy during the systole of the cardiac cycle.
The method of claim 27 , further comprising determining the S 3 threshold based on an temporal average of one or more of the S 1 amplitude, the S 2 amplitude, and the total acoustic energy in one cardiac cycle.
The method of claim 18 , further comprising: estimating a background sound level (Î¼ B ) measured during a predetermined period between an occurrence of S 1 and an adjacent occurrence of S 2 ; and calculating the S 3 threshold by multiplying Î¼ B by K, where K is an adjustable multiplier.
estimating a background sound level (Î¼ B ) measured during a predetermined period between an occurrence of S 1 and an adjacent occurrence of S 2 ; and
calculating the S 3 threshold by multiplying Î¼ B by K, where K is an adjustable multiplier.
The method of claim 33 , further comprising: detecting a heart rate from the cardiac signal; and scaling the predetermined period between the occurrence of S 1 and the adjacent occurrence of S 2 for the detected heart rate.
detecting a heart rate from the cardiac signal; and
scaling the predetermined period between the occurrence of S 1 and the adjacent occurrence of S 2 for the detected heart rate.
A system, comprising: an implantable lead to sense a cardiac signal indicative of ventricular events; an implantable acoustic sensor to sense an acoustic signal indicative of at least second heart sounds (S 2 ) and third heart sounds (S 3 ); and an implantable medical device including: a cardiac signal input to receive the cardiac signal; an acoustic signal input to receive the acoustic signal; and a heart sound detector coupled to the cardiac signal input and the acoustic signal input, the heart sound detector including: an S 2 window generator to generate an S 2 window after a first predetermined delay starting with each of the ventricular events; an S 2 detector to detect S 2 during the S 2 windows; an S 3 window generator, coupled to the S 2 detector, to generate an S 3 window after a second predetermined delay starting with each of the detected S 2 ; and an S 3 detector to detect S 3 during the S 3 windows.
an implantable lead to sense a cardiac signal indicative of ventricular events;
an implantable acoustic sensor to sense an acoustic signal indicative of at least second heart sounds (S 2 ) and third heart sounds (S 3 ); and
an implantable medical device including: a cardiac signal input to receive the cardiac signal; an acoustic signal input to receive the acoustic signal; and a heart sound detector coupled to the cardiac signal input and the acoustic signal input, the heart sound detector including: an S 2 window generator to generate an S 2 window after a first predetermined delay starting with each of the ventricular events; an S 2 detector to detect S 2 during the S 2 windows; an S 3 window generator, coupled to the S 2 detector, to generate an S 3 window after a second predetermined delay starting with each of the detected S 2 ; and an S 3 detector to detect S 3 during the S 3 windows.
a cardiac signal input to receive the cardiac signal;
an acoustic signal input to receive the acoustic signal; and
The system of claim 35 , wherein the implantable acoustic sensor comprises an accelerometer.
The system of claim 35 , wherein the implantable acoustic sensor comprises a microphone.
The system of claim 35 , wherein the implantable medical device further comprises an envelope detector coupled between the acoustic signal input and the heart sound detector, the envelope detector including a rectifier and a low-pass filter coupled to the rectifier.
The system of claim 38 , wherein the implantable medical device further comprises an averaging circuit to improve a signal-to-noise ratio of the acoustic signal by ensemble averaging.
The system of claim 39 , wherein the averaging circuit is adapted to align segments of the acoustic signal using the ventricular events.
The system of claim 39 , wherein the averaging circuit is adapted to align segments of the acoustic signal using occurrences of the S 2 detection.
The system of claim 35 , wherein the implantable medical device further comprises an S 1 detector to detect first heart sounds (S 1 ).
The system of claim 42 , wherein the implantable medical device further comprises a measurement module, coupled to the heart sound detector, to produce parameters related to one or more of S 1 , S 2 , and S 3 .
The system of claim 43 , wherein the measurement module comprises an amplitude detector to detect one or more of an S 1 amplitude, an S 2 amplitude, and an S 3 amplitude.
The system of claim 44 , wherein the S 2 detector comprises an S 2 comparator to compare the acoustic signal to a predetermined S 2 threshold.
The system of claim 45 , wherein the S 2 detector further comprises an S 2 threshold generator coupled to the S 2 comparator, the S 2 threshold generator adapted to determine the S 2 threshold based on the detected S 1 and S 2 amplitudes.
The system of claim 45 , wherein the S 3 detector comprises an S 3 comparator to compare the acoustic signal to a predetermined S 3 threshold.
The system of claim 47 , wherein the S 3 detector further comprises an S 3 threshold generator coupled to the S 3 comparator, the S 3 threshold generator adapted to dynamically adjust the S 3 threshold based on at least one of the detected S 1 and S 2 amplitudes and a percentage of the detected S 2 amplitude.
The system of claim 47 , wherein the measurement module further comprises an energy detector to detect one or more of an energy associated with S 1 , an energy associated with S 2 , an energy associated with S 3 , a total acoustic energy during an cardiac cycle, and a total acoustic energy during systole of the cardiac cycle.
The system of claim 49 , wherein the S 3 detector further comprises an S 3 threshold generator coupled to the S 3 comparator, the S 3 threshold generator adapted to dynamically adjust the S 3 threshold based on at least one of: the total acoustic energy during cardiac cycle; a mean and a standard deviation of the total acoustic energy during cardiac cycle; the total acoustic energy during systole of the cardiac cycle; a mean and a standard deviation of the total acoustic energy during systole of the cardiac cycle; and a temporal average of one or more of the S 1 amplitude, the S 2 amplitude, the total acoustic energy in one cardiac cycle.
The system of claim 47 , wherein the S 3 detector further comprises an S 3 threshold generator coupled to the S 3 comparator, the S 3 threshold generator adapted to dynamically adjust the S 3 threshold based on an estimated background sound level (Î¼ B ) measured during a predetermined period between an occurrence of S 1 and an adjacent occurrence of S 2 .
The system of claim 51 , wherein the S 3 threshold generator comprises an S 3 threshold calculator to calculate the S 3 threshold as Î¼ B *K, where K is an adjustable multiplier.
The system of claim 52 , wherein the implantable medical device further comprises a heart rate detector, couple to the cardiac signal input, to detect a heart rate, and wherein the S 3 threshold generator comprises a scaling module to scale the predetermined period between the occurrence of S 1 and the adjacent occurrence of S 2 for the heart rate.
Ref US20050149136A1: Claims:
A heart sound processing system, comprising: a cardiac signal input to receive a cardiac signal indicative of heart beats; a beat counter, coupled to the cardiac signal input, to count the heart beats; an acoustic signal input to receive an acoustic signal indicative of at least third heart sounds (S3); a heart sound detector, coupled to the acoustic signal input, to detect S3; a heart sound counter, coupled to the heart sound detector, to count S3 beats each being a heart beat during which one of S3 is detected; and a heart sound analyzer coupled to the beat counter and the heart sound counter, the heart sound analyzer including a ratio calculator to calculate an S3 index being a ratio of a number of the S3 beats counted during a predetermined time period to the number of the heart beats counted during the predetermined time period.
a cardiac signal input to receive a cardiac signal indicative of heart beats;
a beat counter, coupled to the cardiac signal input, to count the heart beats;
an acoustic signal input to receive an acoustic signal indicative of at least third heart sounds (S3);
a heart sound detector, coupled to the acoustic signal input, to detect S3;
a heart sound counter, coupled to the heart sound detector, to count S3 beats each being a heart beat during which one of S3 is detected; and
a heart sound analyzer coupled to the beat counter and the heart sound counter, the heart sound analyzer including a ratio calculator to calculate an S3 index being a ratio of a number of the S3 beats counted during a predetermined time period to the number of the heart beats counted during the predetermined time period.
The system of claim 1 , further comprising a measurement timer to time predetermined measurement sessions and predetermined measurement periods each including a plurality of the predetermined measurement sessions.
The system of claim 2 , wherein the measurement timer comprises a measurement session clock to time a predetermined time interval as each of the predetermined measurement sessions.
The system of claim 2 , wherein the measurement timer comprises a measurement session counter to count a predetermined number of heart beats as each of the predetermined measurement sessions.
The system of claim 2 , wherein the measurement timer comprises a measurement period clock to time predetermined time intervals as each of the predetermined measurement periods.
The system of claim 2 , wherein the measurement timer comprises a measurement period counter to count a predetermined number of the predetermined measurement sessions as each of the predetermined measurement period.
The system of claim 2 , wherein the ratio calculator calculates an S3 session ratio being a ratio of a number of the S3 beats counted during one of the predetermined measurement sessions to the number of the heart beats counted during that one of the predetermined measurement sessions, and the heart sound analyzer further comprises an averaging module calculating an average of the S3 session ratios for one of the predetermined measurement periods.
The system of claim 7 , wherein the heart sound analyzer further comprises a trend generator to generate a trend of the S3 index as a moving average of the S3 sess
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