Office Action 5: Final Rejection (2024-04-29)
Rejection types: 103 - Obviousness

CLAIMS:
Listing of Claims:

AMENDMENTS TO THE CLAIMSThis listing of claims will replace all prior versions and listings of claims in the application.

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, wherein the first physiological parameter comprises a frequency of occurrence of an S3 heart sound;
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, wherein to perform the analysis of the trends the processing circuitry is configured to:determine a first variation value of at least one physiological parameter of the plurality of physiological parameters for a first period and a second variation value of the at least one of the physiological parameter for a second period preceding the first period; and
determine whether a comparison of the first variation value and the second variation value satisfies a criterion.

Claim 2. (Canceled).

Claim 3. (Previously Presented): 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. (Previously Presented): 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. (Canceled).

Claim 7. (Previously Presented): The system of claim 1, 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 S4 heart sound.

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

Claim 9. (Canceled).

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. (Previously Presented): 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. (Canceled).

Claim 13. (Previously Presented): 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 first physiological parameter comprises a frequency of occurrence of an S3 heart sound, 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, wherein to perform the analysis of the trends the instructions cause the processing circuitry to:determine a first variation value of at least one physiological parameter of the plurality of physiological parameters for a first period and a second variation value of the at least one of the physiological parameter for a second period preceding the first period;
and

determine whether a comparison of the first variation value and the second variation value satisfies a criterion.

Claim 19. (Canceled).

Claim 20. (Previously Presented): 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 Si heart sound.

Claim 22. (Canceled).

Claim 23. (Previously Presented): 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 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. (Canceled).

Claim 26. (Previously Presented): 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 wherein non-transitory computer-readable storage medium further comprising instructions that, when executed by the processing circuitry, cause the processing circuitry to periodically determine 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 first physiological parameter comprises a frequency of occurrence of an S3 heart sound, 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, wherein to perform the analysis of the trends the processing circuitry is configured to:determine a first variation value of at least one physiological parameter of the plurality of physiological parameters for a first period and a second variation

value of the at least one of the physiological parameter for a second period preceding the first period; anddetermine whether a comparison of the first variation value and the second variation value satisfies a criterion.

Claim 28. (Previously Presented): The insertable cardiac monitor (ICM) of claim 27, wherein the plurality of physiological parameters comprises a measurement of an S1 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, wherein the first physiological parameter comprises a frequency of occurrence of an S3 heart sound;
means for outputting trends of the periodically determined values of the physiological parameters at the remote computing device; andmeans 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, wherein to perform the analysis of the trends the means for determining comprises:means for determining a first variation value of at least one physiological parameter of the plurality of physiological parameters for a first period and a second variation value of the at least one of the physiological parameter for a second period preceding the first period; and
means for determining whether a comparison of the first variation value and the second variation value satisfies a criterion.

Claim 30. (Previously Presented): The system of claim 29, wherein the plurality of physiological parameters comprises a measurement of an S1 heart sound.

Claim 31. (Previously Presented): 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. (Previously Presented): 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.

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 Pgs 10-13, filed 1/18/2024, with respect to the rejection(s) of claim(s) 1, 3-5, 7-8, 10-11 and 13-16,18, 20-21, 23-24, and 26-32 under USC 103 have been fully considered and are persuasive.  For example, on Pages 10-12, the Applicant argued that the current prior art does not disclose the amended claim element: “to perform the analysis of the trends the processing circuitry is configured to: determine a first variation value of at least one physiological parameter of the plurality of physiological parameters for a first period and a second variation value of the at least one of the physiological parameter for a second period preceding the first period; and determine whether a comparison of the first variation value and the second variation value satisfies a criterion.”, support can be found in Specification para. 152. 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), further in view of Gheeraert (US 2016/0045166 A1).
Claim 12 has been cancelled.
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 (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 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, 10-11, 13-16, 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) 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) as cited previously, further in view of Gheeraert (US 2016/0045166 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).
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).
While Stahmann discloses a housing (eg. Fig. 4A 401 housing), Stahmann does not disclose multiple electrodes on the housing.
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.
Stahmann as modified by McCabe teaches the limitations above, but does not disclose determining a heart failure deterioration based on trends and parameters based on heart sounds and ECG.
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.
The combined invention of Stahmann modified by McCabe and Zhang discloses the elements above, but does not disclose the first physiological parameter comprises a frequency of occurrence of an S3 heart sound.
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).
The combined invention of Stahmann modified by McCabe, Zhang, and Siejko discloses the above elements, but does not disclose to perform the analysis of the trends the processing circuitry is configured to: determine a first variation value of at least one physiological parameter of the plurality of physiological parameters for a first period and a second variation value of the at least one of the physiological parameter for a second period preceding the first period; and determine whether a comparison of the first variation value and the second variation value satisfies a criterion.
Gheeraert teaches an ECG analysis system that takes ECG data and compares it to a previous sequence of consecutive data for a patient based on different conditions in the form of difference vectors and provides a signal representative of a risk of a myocardial infarction (eg. Abstract, Para. 31-32, 86, 172-176).
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 invention of Stahmann, McCabe, Zhang, and Siejko with the difference vector analysis as taught by Gheeraert to improve assessment with low sensitivity to false positives (eg. Gheeraert, Para. 18-30). While Gheeraert does not disclose these difference metrics with regards to heart sounds, the claim is written such that a first physiological parameter of a plurality of parameters is a frequency of S3 heart sounds, but is interpreted to be merely a non-limiting example for the amended limitation stating “at least one physiological parameter of the plurality of physiological parameter”, which can be either the ECG based or heart sound based parameters.
Regarding claim 3 and 20, the combined invention of Stahmann, McCabe, Zhang, Siejko, and Gheeraert discloses the indication of the cardiac event comprises an indication of a risk of the cardiac event (eg. Stahmann, Para. 1409-1410).
Regarding claim 4, the combined invention of Stahmann, McCabe, Zhang, Siejko, and Gheeraert 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, Siejko, and Gheeraert 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, Siejko, and Gheeraert 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. Stahmann. Para. 1520).
Regarding claim 8 and 24, the combined invention of Stahmann, McCabe, Zhang, Siejko, and Gheeraert discloses the plurality of physiological parameters comprise a morphological measurement of an S1 heart sound (eg. Stahmann, Para. 1520).
Regarding claim 10 and 26, the combined invention of Stahmann, McCabe, Zhang, Siejko, and Gheeraert 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. Stahmann, Para. 219).
Regarding claim 11, the combined invention of Stahmann, McCabe, Zhang, Siejko, and Gheeraert 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 13, the combined invention of Stahmann, McCabe, Zhang, Siejko, and Gheeraert 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, Siejko, and Gheeraert 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, Siejko, and Gheeraert 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, Siejko, and Gheeraert 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, Siejko, and Gheeraert 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 Gheeraert (US 2016/0045166 A1), further in view of Lee (US 2012/0283705 A1) (cited previously).
Regarding claim 17, the combined invention of Stahmann, McCabe, Zhang, Siejko, and Gheeraert 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 Stahmann, McCabe, Zhang, Siejko, and Gheeraert 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 communication is responsive to the Final Office Action dated April 29, 2024.
Applicant has amended claims 1, 18, 27, and 29. Claims 1, 3-5, 7, 8, 10, 11, 13-18, 20, 21, 23, 24, and 26-32 remain pending.
Applicant respectfully requests entry of the claim amendments after issuance of the Final Office Action. The claim amendments are clerical, and require no further search or consideration.
Claim Re
j
ection Under 35 U.S.C.
&
The Office Action rejected claims 1, 3-5, 7, 8, 10, 11, 13-18, 20, 21, 23, 24, and 26-32 under 35 U.S.C. § 103 as follows:
" Claims 1, 3-5, 7, 8, 10, 11, 13-16, 18, 20, 21, 23, 24, and 26-32 were rejected as
allegedly being unpatentable over U.S. Patent Application Publication No. 2005/0115561
Al by Stahmann et al. (hereinafter, "Stahmann") in view of U.S. Patent Application
Publication No. 2010/0121399 Al by McCabe et al. (hereinafter, "McCabe"), further in
view of U.S. Patent Application Publication No. 2005/0148896 Al by Siejko et al.
(hereinafter, "Siejko"), further in view of U.S. Patent Application Publication No.
2011/0009760 Al by Zhang et al. (hereinafter, "Zhang"), and further in view of U.S.
Patent Application Publication No. 2016/0045166 Al by Gheeraert et al. (hereinafter,
"Gheeraert"); and
" Claim 17 was rejected as allegedly being unpatentable over Stahmann in view of McCabe
in view of Zhang, further in view of Siejko, further in view of Zhang, further in view of Gheeraert, and further in view of U.S. Patent Application Publication No. 2012/0283705
Al by Lee et al. (hereinafter, "Lee").
Applicant respectfully traverses the rejections. The applied references, alone or in any combination, fail to disclose or suggest the features defined by Applicant's 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 a system comprising
"processing circuitry of at least one of [an] insertable cardiac monitor or [a] 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 [] 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, wherein to perform the analysis of the trends the processing circuitry is configured to:
determine a first variation value of at least one physiological parameter of the plurality of physiolo
g
ical parameters for a first period and a second variation value of the at least one physiolo
g
ical parameter for a second period preceding the first period
;
and determine whether a comparison of the first variation value and the second variation value satisfies a criterion,"
as recited by amended independent claim 1, or the similar recitations of amended independent claims 18, 27, and 29.
The Office Action acknowledged that "Stahmann modified by McCabe, Zhang, and
Siejko ... does not disclose .. processing circuitry is configured to: determine a first variation value of at least one physiological parameter of the plurality of physiological parameters for a first period and a second variation value of the at least one of the physiological parameter for a second period preceding the first period; and determine whether a comparison of the first variation value and the second variation value satisfies a criterion."2 The Office Action asserted "Gheeraert teaches an ECG analysis system that takes ECG data and compares it to a previous sequence of consecutive data for a patient based on different conditions in the form of difference vectors and provides a signal representative of a risk of myocardial infarction (eg. Abstract, Para. 31-32, 86, 172-176)."3 The Office Action argued "[i]t would have been obvious ... to have combined the invention of Stahmann, McCabe, Zhang, and Siejko with the difference vector analysis as taught by Gheeraert to improve assessment with low sensitivity to false positives (eg. Gheeraert, Para. 18-30)."4
Applicant respectfully disagrees. Gheeraert describes "calculating a difference vector of the three ST levels with respect to a reference vector . .. obtained by calculating an average of a
1 Emphasis added.
2 Final Office Action dated April 29, 2024, pg. 5.
3 Final Office Action dated April 29, 2024, pp. 5-6.
4 Final Office Action dated April 29, 2024, pg. 6.
plurality of dipole measurements ... [and] generating a signal taking into account this comparison, for example a signal representative of a risk of myocardial infarction occurring in the body of the user."5 However, neither the difference vector, nor the reference vector, is a variation value for a period. Instead, per Gheeraert, the vectors are three-dimensional coordinate representations of three ST levels from three dipoles.6 Consequentially, any comparison of these vectors, e.g., a vector difference, is not comparison of a first variation value and a second variation value, per Applicant's claims.
Furthermore, as acknowledged in the Office Action,7 Gheeraert describes techniques for determining a risk of myocardial infarction,8 and does not appear to suggest that its techniques would be useful for determining whether to present an indication of a heart failure event. As such, even if a person of ordinary skill in the art considered the techniques described by Gheeraert to provide low sensitivity to false positives as suggested in the Office Action, the Office Action does not establish that such a person would have considered it obvious to utilize these techniques to whether to determine whether to "present an indication of a heart failure event," as recited in Applicant's claims.
For at least these reasons, the Office has failed to establish aprimafacie case for non- patentability of Applicant's claims under 35 U.S.C. § 103. Applicant therefore respectfully requests reconsideration and withdrawal of this rejection.
s Gheeraert,    [0172] and [0173].
6 See, e.g., Gheeraert,   [0172].
7 Final Office Action dated April 29, 2024, pg. 6.
8 See, e.g., Gheeraert,   [0173].
CONCLUSION

NEXT 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 7-18, filed 11/27/2024, with respect to claims 1, 3-5, 7-8, 10-11. 13-18, 20-21. 23-24, 26-32 have been fully considered and are persuasive.  The rejection of 1, 3-5, 7-8, 10-11. 13-18, 20-21. 23-24, 26-32 has been withdrawn.
Allowable Subject Matter
Claims 1, 3-5, 7-8, 10-11. 13-18, 20-21. 23-24, 26-32 are allowed.
The following is an examiner’s statement of reasons for allowance: Claims 1, 3-5, 7-8, 10-11. 13-18, 20-21. 23-24, 26-32 are allowable over the cited prior art because the Examiner found that none of the cited prior art discloses 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 heart sounds or 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, wherein to perform the analysis of the trends the processing circuitry is configured to: determine a first variation value of at least one physiological parameter of the plurality of physiological parameters for a first period and a second variation value of the at least one physiological parameter for a second period preceding the first period; and determine whether a comparison of the first variation value and the second variation value satisfies a criterion.
Examiner found closest prior art was the most recent combination as shown in the previous office action ( Stahmann, McCabe, Siejko, Zhang, and Gheeraert) which discloses using a vector of dipole differences, but is not a variation for a period.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion

CITED REFERENCE SUMMARIES: Ref US20120029587A1: Claims:
An implantable medical device for delivering cardiac therapy comprising: monitoring apparatus configured to monitor physiological parameters of a patient, wherein the monitoring apparatus comprises at least two electrodes configured to monitor electrical activity of the patient's vagus nerve; a sensing module operably coupled to the monitoring apparatus and configured to receive the monitored physiological parameters; a therapy delivery module configured to deliver cardiac therapy to the patient; control module operably coupled to the sensing module and to the therapy delivery module and configured to: differentiate between efferent activity and afferent activity of the monitored electrical activity of the patient's vagus nerve, analyze the monitored physiological parameters by at least determining whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced over time, and initiate or adjust cardiac therapy to the patient if the efferent activity of the electrical activity of the patient's vagus nerve is reduced.
monitoring apparatus configured to monitor physiological parameters of a patient, wherein the monitoring apparatus comprises at least two electrodes configured to monitor electrical activity of the patient's vagus nerve;
a sensing module operably coupled to the monitoring apparatus and configured to receive the monitored physiological parameters;
a therapy delivery module configured to deliver cardiac therapy to the patient;
control module operably coupled to the sensing module and to the therapy delivery module and configured to:
differentiate between efferent activity and afferent activity of the monitored electrical activity of the patient's vagus nerve,
analyze the monitored physiological parameters by at least determining whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced over time, and
initiate or adjust cardiac therapy to the patient if the efferent activity of the electrical activity of the patient's vagus nerve is reduced.
The device of claim 1 , wherein the control module is configured to determine whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced by at least comparing the pulses per second of the efferent activity to a selected value.
The device of claim 1 , wherein the control module is configured to determine whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced by at least comparing the pulses per second of presently-monitored efferent activity to the pulses per second of previously-monitored efferent activity.
The device of claim 1 , wherein the control module is further configured to: determine whether the monitored electrical activity of the patient's vagus nerve comprises afferent activity, and determine whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced by at least comparing the efferent activity to the afferent activity.
determine whether the monitored electrical activity of the patient's vagus nerve comprises afferent activity, and
determine whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced by at least comparing the efferent activity to the afferent activity.
The device of claim 1 , wherein the control module is configured to determine whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced by at least comparing the average amplitude of a selected frequency range of the efferent activity to a selected value.
The device of claim 1 , wherein the control module is configured to determine whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced by at least comparing the average amplitude of a selected frequency range of the presently-monitored efferent activity to the average amplitude of the selected frequency range of previously-monitored efferent activity.
The device of claim 1 , wherein the control module is configured to determine whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced by at least comparing the average power of a selected frequency range of the efferent activity to a selected value.
The device of claim 1 , wherein the control module is configured to determine whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced by at least comparing the average power of a selected frequency range of the presently-monitored efferent activity to the average power of the selected frequency range of previously-monitored efferent activity.
The device of claim 1 , wherein the cardiac therapy comprises electrical stimulation to the patient's vagus nerve, and wherein the control module is further configured to deliver electrical stimulation to the patient's vagus nerve after a burst of efferent activity of the electrical activity of the patient's vagus nerve ceases.
The device of claim 1 , wherein the physiological parameters further comprise electrical activity of the patient's heart, and wherein the control module is further configured to: provide a function relating the status of the patient's vagus nerve to the electrical activity of the patient's heart for use in therapy, assess a status of the patient's vagus nerve using the monitored electrical activity of the patient's heart using the function, and initiate or adjust cardiac therapy to the patient based on the assessed status of the patient's vagus nerve.
provide a function relating the status of the patient's vagus nerve to the electrical activity of the patient's heart for use in therapy,
assess a status of the patient's vagus nerve using the monitored electrical activity of the patient's heart using the function, and
initiate or adjust cardiac therapy to the patient based on the assessed status of the patient's vagus nerve.
A method of delivering therapy, wherein the method comprises: monitoring physiological parameters of a patient, wherein the physiological parameters comprise electrical activity of the patient's vagus nerve; determining whether the monitored electrical activity of the patient's vagus nerve comprises efferent activity; analyzing the monitored physiological parameters, wherein analyzing the monitored physiological parameters comprises determining whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced over time; and initiating or adjusting cardiac therapy if the efferent activity of the electrical activity of the patient's vagus nerve is reduced.
monitoring physiological parameters of a patient, wherein the physiological parameters comprise electrical activity of the patient's vagus nerve;
determining whether the monitored electrical activity of the patient's vagus nerve comprises efferent activity;
analyzing the monitored physiological parameters, wherein analyzing the monitored physiological parameters comprises determining whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced over time; and
initiating or adjusting cardiac therapy if the efferent activity of the electrical activity of the patient's vagus nerve is reduced.
The method of claim 11 , wherein determining whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced comprises comparing the pulses per second of the efferent activity to a selected value.
The method of claim 11 , wherein determining whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced comprises comparing the pulses per second of presently-monitored efferent activity to the pulses per second of previously-monitored efferent activity.
The method of claim 11 , wherein the method further comprises determining whether the monitored electrical activity of the patient's vagus nerve comprises afferent activity, and wherein determining whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced comprises comparing the efferent activity to the afferent activity.
The method of claim 11 , wherein determining whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced comprises comparing the average amplitude of a selected frequency range of the efferent activity to a selected value.
The method of claim 11 , wherein determining whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced comprises comparing the average amplitude of a selected frequency range of the presently-monitored efferent activity to the average amplitude of the selected frequency range of previously-monitored efferent activity.
The method of claim 11 , wherein determining whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced comprises comparing the average power of a selected frequency range of the efferent activity to a selected value.
The method of claim 11 , wherein determining whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced comprises comparing the average power of a selected frequency range of the presently-monitored efferent activity to the average power of the selected frequency range of previously-monitored efferent activity.
The method of claim 11 , wherein delivering cardiac therapy comprises delivering electrical stimulation to the patient's vagus nerve, and wherein the method further comprises delivering the electrical stimulation to the patient's vagus nerve for a selected period of time after a burst of efferent activity of the electrical activity of the patient's vagus nerve ceases.
The method of claim 11 , wherein the physiological parameters further comprise electrical activity of the patient's heart, and wherein the method further comprises: providing a function relating the status of the patient's vagus nerve to the electrical activity of the patient's heart for use in therapy, assessing a status of the patient's vagus nerve using the monitored electrical activity of the patient's heart using the function, and initiating or adjusting cardiac therapy to the patient based on the assessed status of the patient's vagus nerve.
providing a function relating the status of the patient's vagus nerve to the electrical activity of the patient's heart for use in therapy,
assessing a status of the patient's vagus nerve using the monitored electrical activity of the patient's heart using the function, and
initiating or adjusting cardiac therapy to the patient based on the assessed status of the patient's vagus nerve.
A method of delivering cardiac therapy comprising: providing a first lead having a first electrode and a second electrode on a distal portion; placing the distal portion of the first lead proximate a vagus nerve such that the first electrode is proximate a central end and the second electrode is proximate a peripheral end; providing a second lead having a first electrode and a second electrode on a distal portion; placing the second lead proximate one of a SA node and an AV node; monitoring electrical activity of the patient's vagus nerve through the first lead; determining whether the monitored electrical activity comprises efferent activity; determining whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced over time; and initiating or adjusting cardiac therapy through the second lead if the efferent activity of the electrical activity of the patient's vagus nerve is reduced.
providing a first lead having a first electrode and a second electrode on a distal portion;
placing the distal portion of the first lead proximate a vagus nerve such that the first electrode is proximate a central end and the second electrode is proximate a peripheral end;
providing a second lead having a first electrode and a second electrode on a distal portion;
placing the second lead proximate one of a SA node and an AV node;
monitoring electrical activity of the patient's vagus nerve through the first lead;
determining whether the monitored electrical activity comprises efferent activity;
determining whether the efferent activity of the electrical activity of the patient's vagus nerve is reduced over time; and
initiating or adjusting cardiac therapy through the second lead if the efferent activity of the electrical activity of the patient's vagus nerve is reduced.
An implantable medical device for delivering therapy for a heart failure patient comprising: monitoring apparatus configured to monitor physiological parameters of a patient, wherein the monitoring apparatus comprises at least two electrodes configured to monitor electrical activity of the patient's phrenic nerve; a sensing module operably coupled to the monitoring apparatus and configured to receive the monitored physiological parameters; a therapy delivery module configured to deliver cardiac therapy to the patient; control module operably coupled to the sensing module and to the therapy delivery module and configured to: differentiate between efferent activity and afferent activity of the monitored electrical activity of the patient's phrenic nerve, analyze the monitored physiological parameters by at least determining whether the efferent activity of the electrical activity of the patient's phrenic nerve is reduced over time, and initiate or adjust electrical stimulation if the efferent activity of the electrical activity of the patient's phrenic nerve is reduced.
monitoring apparatus configured to monitor physiological parameters of a patient, wherein the monitoring apparatus comprises at least two electrodes configured to monitor electrical activity of the patient's phrenic nerve;
differentiate between efferent activity and afferent activity of the monitored electrical activity of the patient's phrenic nerve,
analyze the monitored physiological parameters by at least determining whether the efferent activity of the electrical activity of the patient's phrenic nerve is reduced over time, and
initiate or adjust electrical stimulation if the efferent activity of the electrical activity of the patient's phrenic nerve is reduced.
The device of claim 22 , wherein the control module is configured to determine whether the efferent activity of the electrical activity of the patient's phrenic nerve is reduced by at least comparing the pulses per second of the efferent activity to a selected value.
The device of claim 22 , wherein the control module is configured to determine whether the efferent activity of the electrical activity of the patient's phrenic nerve is reduced by at least comparing the pulses per second of presently-monitored efferent activity to the pulses per second of previously-monitored efferent activity.
The device of claim 22 , wherein the control module is further configured to: determine whether the monitored electrical activity of the patient's phrenic nerve comprises afferent activity, and determine whether the efferent activity of the electrical activity of the patient's phrenic nerve is reduced by at least comparing the efferent activity to the afferent activity.
determine whether the monitored electrical activity of the patient's phrenic nerve comprises afferent activity, and
determine whether the efferent activity of the electrical activity of the patient's phrenic nerve is reduced by at least comparing the efferent activity to the afferent activity.
The device of claim 22 , wherein the control module is configured to determine whether the efferent activity of the electrical activity of the patient's phrenic nerve is reduced by at least comparing the average amplitude of a selected frequency range of the efferent activity to a selected value.
The device of claim 22 , wherein the control module is configured to determine whether the efferent activity of the electrical activity of the patient's phrenic nerve is reduced by at least comparing the average amplitude of a selected frequency range of the presently-monitored efferent activity to the average amplitude of the selected frequency range of previously-monitored efferent activity.
The device of claim 22 , wherein the control module is configured to determine whether the efferent activity of the electrical activity of the patient's phrenic nerve is reduced by at least comparing the average power of a selected frequency range of the efferent activity to a selected value.
The device of claim 22 , wherein the control module is configured to determine whether the efferent activity of the electrical activity of the patient's phrenic nerve is reduced by at least comparing the average power of a selected frequency range of the presently-monitored efferent activity to the average power of the selected frequency range of previously-monitored efferent activity.
The device of claim 22 , wherein the cardiac therapy comprises electrical stimulation to the patient's phrenic nerve, and wherein the control module is further configured to deliver electrical stimulation to the patient's phrenic nerve after a burst of efferent activity of the electrical activity of the patient's phrenic nerve ceases.
The device of claim 22 , wherein the physiological parameters further comprise electrical activity of the patient's heart, and wherein the control module is further configured to: provide a function relating the status of the patient's phrenic nerve to the electrical activity of the patient's heart for use in therapy, assess a status of the patient's phrenic nerve using the monitored electrical activity of the patient's heart using the function, and initiate or adjust cardiac therapy to the patient based on the assessed status of the patient's phrenic nerve.
provide a function relating the status of the patient's phrenic nerve to the electrical activity of the patient's heart for use in therapy,
assess a status of the patient's phrenic nerve using the monitored electrical activity of the patient's heart using the function, and
initiate or adjust cardiac therapy to the patient based on the assessed status of the patient's phrenic nerve.
A method of delivering therapy comprising: monitoring physiological parameters of a patient, wherein the physiological parameters comprise electrical activity of the patient's phrenic nerve; determining whether the monitored electrical activity of the patient's phrenic nerve comprises efferent activity; analyzing the monitored physiological parameters, wherein analyzing the monitored physiological parameters comprises determining whether the efferent activity of the electrical activity of the patient's phrenic nerve is reduced over time; and initiating or adjusting cardiac therapy if the efferent activity of the electrical activity of the patient's phrenic nerve is reduced.
monitoring physiological parameters of a patient, wherein the physiological parameters comprise electrical activity of the patient's phrenic nerve;
determining whether the monitored electrical activity of the patient's phrenic nerve comprises efferent activity;
analyzing the monitored physiological parameters, wherein analyzing the monitored physiological parameters comprises determining whether the efferent activity of the electrical activity of the patient's phrenic nerve is reduced over time; and
initiating or adjusting cardiac therapy if the efferent activity of the electrical activity of the patient's phrenic nerve is reduced.
The method of claim 32 , wherein determining whether the efferent activity of the electrical activity of the patient's phrenic nerve is reduced comprises comparing the pulses per second of the efferent activity to a selected value.
The method of claim 32 , wherein determining whether the efferent activity of the electrical activity of the patient's phrenic nerve is reduced comprises comparing the pulses per second of presently-monitored effer
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