Office Action 2: Non-Final Rejection (2022-11-16)
Rejection types: 103 - Obviousness

CLAIMS:
LISTING OF T H NC CLAIMS This listing of claims is provided for the Examiner's convenience and is not intended to be entered to amend the claims.

Listing of Claims:

Claim 1 (Original): A system comprising:
an insertable cardiac monitor (ICM) comprising:
a housing configured for subcutaneous implantation within a patient, 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;
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, 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;
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.

Claim 2 (Original): The system of claim 1, wherein the cardiac event is a heart failure event.

Claim 3 (Original): The system of claim 1, wherein the indication of the cardiac event comprises an indication of a risk of the cardiac event.

Claim 4 (Original): The system of claim 1, wherein 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 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 S1 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 (Original): The system of claim 1, wherein 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.

Claim 12 (Original): 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 cardiac event based on the determination.

Claim 13 (Original): The system of claim 1, wherein 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.

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 (Original): 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 the ICM comprises:
a housing configured for subcutaneous implantation within a patient, 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;
a heart sound sensor, wherein the ICM is configured to sense the heart sounds via the heart sound sensor; and
a plurality of electrodes, 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 cardiac event based on an analysis of the trends of the periodically determined values of the physiological parameters.

Claim 19 (Original): The non-transitory computer-readable storage medium of claim 18, wherein the cardiac event is a heart failure event.

Claim 20 (Original): The non-transitory computer-readable storage medium of claim 18, wherein the indication of the cardiac event comprises an indication of a risk of the cardiac 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 (Original): An insertable cardiac monitor (ICM) comprising:
a housing configured for subcutaneous implantation within a patient, 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, 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, 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 that 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 cardiac 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 (Original): A system comprising:
an insertable cardiac monitor (ICM) comprising:
a housing configured for subcutaneous implantation within a patient, 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;
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, 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;
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 cardiac 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.
2 3 4 5 6 7 8

OFFICE ACTION:
The Corrected Office Action Supersedes the previous 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 9-10, filed 10/11/2022, with respect to the 112 rejections have been fully considered and are persuasive.  The 112 rejections of claims 1-30 has been withdrawn. The 102 rejection of claim 17 is also withdrawn.
Applicant's arguments filed 10/11/2022 have been fully considered but they are not persuasive.
With regards to the Applicant’s arguments to the independent claims 1, 18, 27, and 29, on the length range not being disclosed, the Stahmann reference implicitly discloses it by giving volumetric and surface area dimensions (eg. Para. 266) which can be used to solve for a length. The Examiner used a volume of a rectangular prism formula using the metrics of 20-100 cc and thickness of 0.4-2cm to get a range of 38.7-86.6 mm length range using the assumption that the surface area is a square for ease of calculation, which falls within the claimed length range.
With regards to claims 3 and 20 arguing the Stahman reference does not disclose an indication of a risk of cardiac event, the Examiner asserts that the Stahmann reference in Para. 1409-1410 implicitly recites an assessment unit using a visual/audio indication diagnostic information related to various medical disorders or diseases affecting the patient, which can further detect the presence, regression/progression, and onset/offset of a medical disorder using trending and analysis (eg. Para 1410). Stahmann discloses these medical disorders can include heart failure (eg. Para. 4, 940-941, and 1322). The Examiner interprets analyzing and displaying the progression of diagnostic information such as Cheyne-Stokes respiration (eg Para. 8) as indicating a risk of congestive heart failure (eg. Para. 357).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA  35 U.S.C. 102 and 103 (or as subject to pre-AIA  35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-16 and 18-30 are rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments of Stahmann (US 2005/0115561 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); and a plurality of electrodes (eg. Para. 217, electrodes 210), 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).
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).
Regarding claim 2 and 19, Stahmann discloses the cardiac event is a heart failure event. (eg. Para. 972).
Regarding claim 3 and 20, Stahmann discloses the indication of the cardiac event comprises an indication of a risk of the cardiac event (eg. Para. 1409-1410).
Regarding claim 4, Stahmann 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, Stahmann discloses the plurality of physiological parameters comprise a measurement of an S1 heart sound (eg. Para. 219, 1520).
Regarding claim 6 and 22, Stahmann 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, Stahmann 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, Stahmann discloses the plurality of physiological parameters comprise a morphological measurement of an S1 heart sound (eg. Para. 1520).
Regarding claim 9 and 25, Stahmann discloses the plurality of physiological parameters comprise a presence/frequency of an S3 heart sound (eg. Para. 1520).
Regarding claim 10 and 26, Stahmann 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, Stahmann 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, Stahmann discloses the processing circuitry is configured to determine whether a change of at least one of the physiological parameters in a period is significantly 2PATENT CO00013179US02CON / 1111-511US03 greater 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).
Regarding claim 13, Stahmann 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, Stahmann 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, Stahmann 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, Stahmann 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).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Stahmann (US 2005/0115561 A1) in view of Lee (US 2012/0283705 A1).
Regarding claim 17, Stahmann 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 REBUTTAL: REMARKS
This Amendment is responsive to the Office Action dated November 16, 2022.
Applicant has amended claims 1, 3, 4, 11-13, 18, 20, 27, and 29, canceled claims 2 and 19, and added new claims 31 and 32. Claims 1, 3-18, and 20-32 are pending upon entry of this Amendment.
Interview Summary
A telephonic interview was conducted on January 24, 2023, between Applicant's undersigned representative, and Examiners Michael J. Lau and Carl Layno. The parties discussed the rejection of independent claim 1 as allegedly being unpatentable over U.S. Patent Publication No. 2005/0115561 by Stahmann et al. (hereinafter, "Stahmann"). Applicant's representative proposed amendments to claim 1 similar to those presented in this Amendment. The Examiners identified additional portions of Stahmann (e.g., paragraphs [1320]-[1321] and [1516]-[1517]) that allegedly disclose subject matter of amended claim 1. No agreement was reached, and no other issues were discussed, nor items presented.
Claim Re
j
ection Under 35 U.S.C.
&
The Office Action rejected claims 1-30 under 35 U.S.C. § 103 as follows:
" Claims 1-16 and 18-30 were rejected as allegedly being unpatentable over Stahmann;
and
" Claim 17 was rejected as allegedly being unpatentable over Stahmann in view of U.S.
Publication No. 2012/0283705 by Lee et al. (hereinafter, "Lee").
Without conceding the merits of the rejections, and in the interest of advancing prosecution to an indication of allowance, Applicant has amended the claims. 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, Stahmann fails to disclose or suggest "a plurality of electrodes on [a]
housing, wherein [an] ICM is configured to sense an electrocardiogram (ECG) of [a] patient via
the plurality of electrodes," as recited by independent claim 1, or the similar recitations of amended independent claims 18, 27, and 29. The Office Action cited to electrodes 210 and paragraphs [0217] and [0376] of Stahmann as allegedly disclosing a plurality of electrodes used to sense an ECG.1 In Stahmann, reference number 210 refers to a cardiac device in FIGS. 2A and 2B, rather than electrodes. Directly contrary to a plurality of electrodes on a housing of an ICM, paragraph [0217] of Stahmann describes, inter alia, "[t]he intracardiac lead system 410 includes one or more electrodes configured to sense electrical activity of the heart . ..." Paragraph [0376] of Stahmann is completely unrelated to ECG sensing or electrodes. In FIGS. 5C-5E, Stahmann depicts housing 531 of ITCS 500, which the Office Action relied on as allegedly meeting other requirements of a housing in Applicant's claims, as having a single electrode 533, rather than a plurality of electrodes. Moreover, Stahmann does not suggest that ITCS 500 is configured to sense an ECG via a plurality electrodes on housing 531.
Stahmann also does not 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; 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," as recited by amended claim 1, or the similar recitations of amended independent claims 18, 27, and 29.
In rejecting previously presented claims 2 and 19, the Office Action alleged that
paragraph [0972] of Stahmann discloses determining whether to present an indication of a heart failure event based on an analysis of trends of periodically determined values of physiological parameters. Paragraph [0972] of Stahmann does not mention a heart failure event, much less determining whether to present an indication of a heart failure event based on an analysis of trends of values of a plurality of physiological parameters determined based on an ECG and heart sounds. During the Examiner Interview, the Examiners identified paragraphs
1 Office Action dated November 16, 2022, pg. 4.
[1320]-[1321] and [1516]-[1517] as allegedly being relevant to this claim feature. However, paragraphs [1320]-[1321] and [1516]-[1517] do not discuss heart failure, much less "processing circuitry configured to ... determine whether to present an indication of a heart failure event based on an analysis of [] trends of [] values of [] physiological parameters [periodically determined based on heart sounds and an ECG]," as recited by claim 1, or the similar recitations of independent claims 18, 27, and 29.
For at least the reasons discussed above, independent claims 1, 18, 27, and 29 are
patentable over the applied references. The dependent claims, i.e., claims 3-17, 20-26, 28, and 30, incorporate the requirements of the respective independent claims.2 Accordingly, the dependent claims are likewise patentable.
Moreover, the dependent claims include a number of features likewise not disclosed or suggested by the applied references. For example, the applied references fail to disclose or suggest "the indication of the heart failure event comprises an indication of a risk of the heart failure event," as recited by claims 3 and 20. The Office Action cited paragraphs [1409]-[1410] of Stahmann as allegedly disclosing this feature. However, paragraphs [1409]-[1410] of Stahmann do not mention risk or heart failure, and instead describe determining presence or absence of a disease or disorder. For example, paragraph [1410] describes "[i]f changes in the conditions indicative of physiological changes or symptoms caused by the disease are consistent with threshold levels, a presence of the disease or disorder may be determined."
For at least these reasons, the Office Action failed to establish a primafacie case for non- patentability of Applicant's claims 1, 3-18, and 20-30 under 35 U.S.C. § 103. Applicant therefore respectfully requests reconsideration and withdrawal of this rejection.
New Claims
Applicant has added new claims 31 and 32. The applied references fail to disclose or suggest the recitations of new claims 31 and 32. No new matter is added by way of claims 31 and 32.
2 35 U.S.C. § 112(d).
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 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.

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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