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 Objections
Claim 9-10 are objected to because of the following informalities: Claim 9 recites “Rescaled signal []” which should be changed to all lower-case letters.
Claim 10 recites “Gain []” which should be changed to all lower-case letters.
Appropriate correction is required.
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 4-5, 19-20 are 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 4 recites the limitation "apply a gain". It is unclear and indefinite what “gain” is being applied. Is it the gains calculated in claim 1 or another? There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "apply a gain". It is unclear and indefinite what “gain” is being applied. Is it the gains calculated in claim 1 or another? There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "applying a gain". It is unclear and indefinite what “gain” is being applied. Is it the gains calculated in claim 1 or another? There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "applying a gain". It is unclear and indefinite what “gain” is being applied. Is it the gains calculated in claim 1 or another? There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-6, 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over single reference US20210259611A1 to Dawoud et al (hereinafter “Dawoud”).
Regarding Claims 1, 14-15. (Previously Presented): Dawoud discloses a system for processing a sensed electrocardiogram (ECG) signal to change a visualization of the sensed ECG signal (para 0145, fig. 6), the system comprising: a memory configured to store the sensed ECG signal (para 0145); and processing circuitry communicatively coupled to the memory, the processing circuitry (para 0145-0146) being configured to: receive the sensed ECG signal (para 0165-0166); at least one of normalize at least one R-wave of the sensed ECG signal or amplify at least one P-wave of the sensed ECG signal to generate a processed ECG signal, wherein to normalize the at least one R-wave, the processing circuitry is configured to apply a first amplitude gain to the sensed ECG signal, the first amplitude gain based on an R-wave amplitude deviation, wherein the R-wave amplitude deviation comprises a difference between a largest and a smallest signal envelope deviation of a first signal envelope, and wherein to amplify the at least one P-wave, the processing circuitry is configured to apply a second amplitude gain to the sensed ECG signal, the second amplitude gain based on a sensed ECG signal deviation amplitude (para 0171); and output the processed ECG signal for visualization by a clinician for diagnosis of a cardiac episode (para 0142-0143, 0155, etc. fig 6).
Regarding Claim 2 and 17. (Original): Dawoud 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 the at least one of normalizing the at least one R-wave of the sensed ECG signal or amplifying the at least one P-wave of the sensed ECG signal to generate a processed ECG signal is based on the one or more visualization criterion associated with the sensed ECG signal being met (para 0171).
Regarding Claims 3 and 18. (Original): Dawoud discloses the system of claim 2, wherein the one or more visualization criterion comprise at least one of an R-wave amplitude deviation level meeting a threshold or an amplitude of a P-wave meeting a threshold (para 0171).
Regarding Claims 4 and 19. (Currently Amended): Dawoud discloses the system of claim 1, wherein the processing circuitry is configured to normalize at least one R-wave and as part of normalizing the at least one R-wave, the processing circuitry is configured to: remove an ECG signal mean or median from the sensed ECG signal; determine the first signal envelope of the sensed ECG signal and determine an R-wave amplitude deviation; determine that the R-wave amplitude deviation meets a threshold; determine a plurality of signal envelopes using moving windows; determine a respective R-wave amplitude deviation for each moving window; determine a smallest R-wave amplitude deviation of the respective R-wave amplitude deviations and set a maximum R-wave amplitude deviation of the processed ECG signal to be equal to a multiple of the smallest R-wave amplitude deviation; determine that the respective R-wave amplitude deviation is less than the maximum R- wave amplitude deviation; set an R-wave amplitude deviation of the processed ECG signal to equal the respective R- wave amplitude deviation; and apply a gain to the processed ECG signal (para 0369-0267, fig 9E).
Regarding Claims 5 and 20. (Currently Amended): Dawoud discloses the system of claim 1, wherein the processing circuitry is configured to normalize at least one R-wave and as part of normalizing the at least one R-wave, the processing circuitry is configured to: remove an ECG signal mean or median from the sensed ECG signal; determine a first signal envelope of the sensed ECG signal and determine an R-wave amplitude deviation, the determined R-wave amplitude deviation comprising a difference between a largest and a smallest signal envelope deviations; determine that the R-wave amplitude deviation meets a threshold; determine a plurality of signal envelopes using moving windows; determine a respective R-wave amplitude deviation for each moving window; determine a smallest R-wave amplitude deviation of the respective R-wave amplitude deviations and set a maximum R-wave amplitude deviation of the processed ECG signal to be equal to a multiple of the smallest R-wave amplitude deviation; determine that a respective R-wave amplitude deviation is not less than the maximum R- wave amplitude deviation; cap an R-wave amplitude deviation of the processed ECG signal to the maximum R-wave amplitude deviation; and apply a gain to the processed ECG signal (para 0369-0267, fig 9E).
Regarding Claim 6. (Currently Amended): Dawoud discloses the system of claim 4, wherein as part of determining the first signal envelope of the sensed ECG signal, the processing circuitry is configured to apply a moving window to the sensed ECG signal, the moving window having an 8 second length and a 1 second movement (para 0260).
Regarding Claim 11. (Currently Amended): Dawoud discloses the system of claim 1, wherein the processing circuitry is further configured to receive an indication of a type of device-detected cardiac episode, and wherein as part of generating the processed ECG signal, the processing circuitry is configured to process at least one of low frequency noise or high frequency noise in the sensed ECG signal based, at least in part, on the indication (para 0204).
Regarding Claim 12. (Original): Dawoud discloses the system of claim 11, wherein the processing circuitry is further configured: determine that the indication is of a device-detected atrial fibrillation (AF) episode, pause, bradycardia, tachycardia, or atrial tachycardia; and based on the indication being of a device-detected atrial fibrillation (AF) episode, pause, bradycardia, tachycardia, or atrial tachycardia, normalize the at least one R-wave (para 0198).
Regarding Claim 13. (Currently Amended): Dawoud 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; and receive clinician visualization ratings for one or more of the plurality of processed ECG signals, wherein the at least one of normalizing of the at least one R-wave or amplifying the at least one P-wave in the sensed ECG signal is based, at least in part, on the clinician visualization ratings (para 0251, 0253).
Regarding Claim 16. (New): Dawoud discloses the system of claim 1, wherein the sensed ECG signal is sensed by an insertable cardiac monitor via a plurality of subcutaneous electrodes (para 0014, 0077).
Claim(s) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dawoud as applied to claims above, and further in view of US 20220133168A1 to Reisfeld et al. (hereinafter “Reisfeld”)
Regarding Claim 7. (Currently Amended): Dawoud discloses the system of claim 1, Dawoud discloses R-wave amplification (para 0259-0267) but fails to disclose wherein the processing circuitry is configured to amplify at least one P-wave of the sensed ECG signal and as part of amplifying the at least one P-wave, the processing circuitry is configured to: remove an ECG signal mean or median from the sensed ECG signal; rescale the sensed ECG signal to a predetermined range; determine a second signal envelope; determine the sensed ECG signal deviation amplitude; determine a rescaled signal deviation amplitude; determine a gain based on the rescaled signal deviation amplitude; and multiply the sensed ECG signal by the determined gain.
Reisfeld, from a similar field of endeavor teaches processing the P-wave signal (para 0058-0059). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Dawoud with the teachings of Reisfeld, because doing so would provide the predictable result of allowing for processing the P-wave signal.
Regarding Claim 8. (Original): Dawoud as modified by Reisfeld renders obvious the system of claim 7, wherein as part of determining the second signal envelope of the sensed ECG signal, the processing circuitry is configured to apply a moving window to the sensed ECG signal, the moving window having a 62.5ms length and a 62.5ms movement (see rejection of claim 7, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claim 9. (Currently Amended): Dawoud as modified by Reisfeld renders obvious the system of claim 7, wherein as part of determining the rescaled signal deviation amplitude, the processing circuitry is configured to apply: Rescaled signal deviation amplitude = A + (K-A)/(C+Qe-B*(original signal deviation))1/v where A=0, K=1, C=1, B=10, Q=0.5, and v=0.1 (see rejection of claim 7, Reisfeld para 0029, 0058-0059).
Regarding Claim 10. (Currently Amended): Dawoud discloses the system of claim 1, but fails to disclose wherein as part of determining the gain, the processing circuitry is configured to apply: Gain = 0.8/(0.8 + rescaled signal deviation amplitude).
Reisfeld, from a similar field of endeavor teaches calculating a gain factor (para 0058-0059). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Dawoud with the teachings of Reisfeld, because doing so would provide the predictable result of calculating and applying the gain factor to the ECG signal for displaying the ECG.
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796
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