Office Action 1: Non-Final Rejection (2022-07-08)
Rejection types: 102 - Lack of Novelty, 112 - Written Description/Enablement

CLAIMS:
WHAT IS CLAIMED IS:

1\. 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.
2\. The system of claim 1, wherein the cardiac event is a heart failure event.
3\. The system of claim 1, wherein the indication of the cardiac event comprises an indication of a risk of the cardiac event.
4\. 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.
5\. The system of claim 1, wherein the plurality of physiological parameters comprise a measurement of an S1 heart sound.
6\. The system of claim 1, wherein the plurality of physiological parameters comprise a measurement of an S3 heart sound.
7\. 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.
8\. The system of claim 1, wherein the plurality of physiological parameters comprise a morphological measurement of an S1 heart sound.
9\. The system of claim 1, wherein the plurality of physiological parameters comprise a presence/frequency of an S3 heart sound.
10\. 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.
11\. 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.
12\. 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.
13\. 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.
14\. 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.
15\. The system of claim 1, wherein the housing defines an elongated rectangular prism comprising a rounded distal end and a rounded proximal end.
16\. 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.
17\. The system of claim 1, wherein a volume of the ICM is less than 1.5 cubic centimeters.
18\. 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.
19\. The non-transitory computer-readable storage medium of claim 18, wherein the cardiac event is a heart failure event.
20\. 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.
21\. The non-transitory computer-readable storage medium of claim 18, wherein the plurality of physiological parameters comprise a measurement of an S1 heart sound.
22\. The non-transitory computer-readable storage medium of claim 18, wherein the plurality of physiological parameters comprise a measurement of an S3 heart sound.
23\. 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.
24\. 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.
25\. 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.
26\. 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.
27\. 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.
28\. 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.
29\. 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.
30\. The system of claim 29, 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. 1 2 3 4 5 6

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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA  35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.  The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph:
(A)	the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B)	the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C)	the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Such claim limitations are in claim 29 as “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.” The examiner interprets these as a processor.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.  Such claim limitation(s) is/are: “processing circuitry configured to” in claims 1 and 27. The Examiner interprets this as any generic processor.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, applicant may:  (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b)  CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-30 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA  35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, 18, 27, and 29, it is unclear if the processing circuitry of the at least one of the insertable cardiac monitor or the remote computing device is located interior or exterior of the patient. Further clarification is needed.
Independent claims 1, 18, 27, and 29 are rejected under USC 112, therefore respective dependent claims 2-17, 19-26, 28, and 30 are also rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA  35 U.S.C. 102 and 103 (or as subject to pre-AIA  35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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 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).
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).
Regarding claim 17, Stahmann discloses a volume of the ICM is less than 1.5 cubic centimeters (eg. Para. 266)
Conclusion


NEXT 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

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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