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 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.
Claim 2 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.
Claim 2 recites the limitation "the one more wavelet transforms" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. Examiner believes it should read “the one or more wavelet transforms”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Serra Autonell (US 20100016747).
Regarding claim 1, Serra Autonell discloses a system for processing a sensed electrocardiogram (ECG) signal to change a visualization of the sensed ECG signal (Fig. 4a-d, section 0067), the system comprising:
a memory configured to store the sensed ECG signal (section 0051); and
processing circuitry communicatively coupled to the memory (section 0051), the processing circuitry being configured to:
receive the sensed ECG signal (Fig. 1, section 0051);
process at least one of low frequency noise or high frequency noise in the sensed ECG signal to generate a processed ECG signal in which the at least one of the low frequency noise or the high frequency noise is mitigated (section 0067),
wherein the ECG signal includes a plurality of waves, and the processing of the at least one of the low frequency noise or the high frequency noise preserves a morphology of the waves (Section 0067), and
wherein as part of processing the at least one of low frequency noise or high frequency noise in the sensed ECG signal, the processing circuitry is configured to determine one or more wavelet transforms to the ECG signal (section 0067, 0073); and
output the processed ECG signal with the at least one of the low frequency noise or the high frequency noise mitigated and the morphology of the waves preserved for visualization by a clinician for diagnosis of a cardiac episode (Fig. 4c, section 0051-0073).
Regarding claim 2, Serra Autonell discloses the system of claim 1, wherein to process the at least one of the low frequency noise or the high frequency noise comprising determining the one more wavelet transforms, the processing circuitry is configured to:
determine a wavelet transform of the ECG signal (section 0067, 0073);
process the wavelet transform (section 0069, 0073); and
determine an inverse wavelet transform of the processed wavelet transform to generate the processed ECG signal (Section 0069, 0073).
Regarding claim 3, Serra Autonell discloses the system of claim 1, wherein
the processing circuitry is further configured to determine that one or more visualization criterion associated with the sensed ECG signal are met, wherein processing the at least one of the low frequency noise or the high frequency noise in the sensed ECG signal to generate the processed ECG signal is based on the one or more visualization criterion associated with the sensed ECG signal being met (section 0087).
Regarding claim 4, Serra Autonell discloses the system of claim 3, wherein
the one or more visualization criterion comprises at least one of an amplitude of the low frequency noise meeting a threshold or an amplitude of the high frequency noise meeting a threshold (section 0087).
Regarding claim 5, Serra Autonell discloses The system of claim 1, wherein
the wavelet transform is an Nth order stationary wavelet transform, and wherein the processing circuitry is configured to process the low frequency noise, and as part of processing the low frequency noise (section 0067, 0073), the processing circuitry is configured to:
remove an ECG signal mean or median from the sensed ECG signal (section 0067, 0073); and
reduce an amplitude of Nth level approximation samples (Section 0067, 0073).
Regarding claim 6, Serra Autonell discloses the system of claim 5, wherein
the Nth order stationary wavelet transform comprises a 7th order transform using a Haar wavelet (Section 0067).
Regarding claim 7, Serra Autonell discloses the system of claim 1, wherein
the wavelet transform is an Nth order stationary wavelet transform (Sections 0067, 0073) and
wherein the processing circuitry is configured to process the high frequency noise and as part of processing the high frequency noise (section 0069, 0073), the processing circuitry is configured to:
pre-process device-determined beat markers or re-compute beat markers (Section 0076);
remove an ECG signal mean or median from the sensed ECG signal (Section 0069); and
except within a predetermined number of samples around each beat marker location, reduce an amplitude of all other first and second level detail samples (Section 0073).
Regarding claim 8, Serra Autonell discloses the system of claim 7, wherein
the Nth order stationary wavelet transform comprises a 7th order transform using a Haar wavelet (Section 0067).
Regarding claim 9, Serra Autonell discloses The system of claim 1, wherein
the processing circuitry is further configured to receive, from a clinician via a user interface, an indication of a selected level of processing of the at least one of the low frequency noise or the high frequency noise in the sensed ECG signal (section 0069, 0073), wherein
the processing the at least one of low frequency noise or high frequency noise in the sensed ECG signal is based, at least in part, on the indication (section 0069, 0073).
Regarding claim 10, Serra Autonell discloses The system of claim 1, wherein
the processing circuitry is further configured to receive an indication, and wherein the processing the at least one of low frequency noise or high frequency noise in the sensed ECG signal is based, at least in part, on the indication (section 0069, 0073).
Regarding claim 11, Serra Autonell discloses the system of claim 10, wherein
the processing circuitry is further configured to at least one of: determine whether the indication is of a device-detected atrial fibrillation (AF) episode (section 0013), wherein if the indication is of the device-detected AF episode, the processing circuitry is configured to process the high frequency noise and process the low frequency noise after processing the high frequency noise (section 0069, 0073); or
determine whether the indication is of a device-detected pause, bradycardia, tachycardia, or atrial tachycardia, wherein if the indication is of the device-detected pause, bradycardia, tachycardia, or atrial tachycardia, the processing circuitry is configured to process the low frequency noise and process the high frequency noise after processing the low frequency noise (Section 0072).
Regarding claim 12, Serra Autonell discloses The system of claim 1, wherein
the processing circuitry is further configured to: present to a clinician a set of representative processed ECG signals, the set of representative processed ECG signals comprising a plurality of processed ECG signals being processed differently (section 0067, 0073); and
receive clinician visualization ratings for one or more of the plurality of processed ECG signals, wherein the processing of the at least one of low frequency noise or high frequency noise in the sensed ECG signal is based, at least in part, on the clinician visualization ratings (abstract, section 0051).
Regarding claim 13, Serra Autonell discloses The system of claim 1, wherein the processing circuitry is further configured to:
present to a clinician a set of representative processed ECG signals, the set of representative processed ECG signals comprising a plurality of processed ECG signals of a particular patient being processed differently (section 0067, 0073); and
receive patient visualization ratings from a clinician for one or more of the plurality of processed ECG signals, wherein the processing of the at least one of low frequency noise or high frequency noise in the sensed ECG signal is based, at least in part, on the patient visualization ratings (abstract, section 0051).
Regarding claim 14, Serra Autonell discloses a method of processing a sensed electrocardiogram (ECG) signal to change a visualization of the sensed ECG signal (Figs. 4a-d, section 0067), the method comprising:
receiving the sensed ECG signal (section 0051);
processing at least one of low frequency noise or high frequency noise in the sensed ECG signal to generate a processed ECG signal in which the at least one of the low frequency noise or the high frequency noise is mitigated (section 0067),
wherein the ECG signal includes a plurality of waves, and the processing of the at least one of the low frequency noise or the high frequency noise preserves a morphology of the waves, and wherein processing the at least one of low frequency noise or high frequency noise in the sensed ECG signal comprises determining, one or more wavelet transforms to the ECG signal (section 0067, 0073) and
outputting the processed ECG signal with the at least one of the low frequency noise or the high frequency noise mitigated and the morphology of the waves preserved for visualization by a clinician for diagnosis by the clinician of a cardiac episode (Fig. 4c, Section 0051, 0073).
Regarding claim 15, Serra Autonell discloses a non-transitory computer-readable storage medium storing instructions (Fig. 4a-d, sections 0051, 0067), which when executed, cause processing circuitry to:
receive a sensed electrocardiogram (ECG) signal (section 0051);
process at least one of low frequency noise or high frequency noise in the sensed ECG signal to generate a processed ECG signal in which the at least one of the low frequency noise or the high frequency noise is mitigated (Section 0067),
wherein the ECG signal includes a plurality of waves, and the processing of the at least one of the low frequency noise or the high frequency noise preserves a morphology of the waves, and wherein as part of processing the at least one of low frequency noise or high frequency noise in the sensed ECG signal, the processing circuitry is configured to determine one or more wavelet transforms to the ECG signal (section 0067, 0073); and
output the processed ECG signal for visualization by a clinician for diagnosis of a cardiac episode (Fig. 4c, section 0051, 0073).
Regarding claim 16, Serra Autonell discloses The system of claim 1, wherein
as part of generating the processed ECG signal, the processing circuitry is configured to at least one of normalize at least one R-wave amplitude or amplify at least one P-wave amplitude (Section 0046, 0067-0069).
Regarding claim 17, Serra Autonell discloses The system of claim 1, wherein
the sensed ECG signal is sensed by an insertable cardiac monitor via a plurality of subcutaneous electrodes (Section 0010).
Regarding claim 18, Serra Autonell discloses The method of claim 14, wherein
processing the at least one of the low frequency noise or the high frequency noise (section 0067, 0073) comprises:
determining a wavelet transform of the ECG signal (section 0067, 0073);
processing the wavelet transform (section 0067, 0073); and
determining an inverse wavelet transform of the processed wavelet transform to generate the processed ECG signal (Section 0069).
Regarding claim 19, Serra Autonell discloses The method of claim 14, further comprising
determining that one or more visualization criterion associated with the sensed ECG signal are met, wherein the processing the at least one of the low frequency noise or the high frequency noise in the sensed ECG signal to generate the processed ECG signal is based on the one or more visualization criterion associated with the sensed ECG signal being met (Fig. 4c, section 0051, 0073).
Regarding claim 20, Serra Autonell discloses The method of claim 19, wherein
the one or more visualization criterion comprise at least one of an amplitude of the low frequency noise meeting a threshold or an amplitude of the high frequency noise meeting a threshold (section 0087).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796
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