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 argument with respect to the definiteness of the terms “wide” and “narrow” have been considered and are persuasive. The 35 USC rejections of the claims have been withdrawn.
Applicant's amendment and arguments filed 4/17/2026 have been fully considered but they are not persuasive. Applicant amended claim 1 to include the use of dV/dt as an artifact characteristic used to identify an artifact. This limitation had been previously addressed by the combination of Nallathambi et al. (2022/0001184) in view of Grievous et al. (5,127,401). Applicant has not provided any arguments specific to the teachings of Grievous and the use of derivatives to determine artifacts. The rejection is maintained and the rejection previously applied to claim 4 has been incorporated into the rejection of Claim 1.
Regarding Applicant’s argument that Nallathambi’s “flat line of constant values…does not ‘extend between’ the first and second data points of the cardiac signal. Instead, it merely holds a fixed value regardless of the actual signal values at the boundary points” have been considered and are not persuasive. The claim requires “replacing the removed pacing artifact in the cardiac signal with replacement data points disposed along a straight line that extends between the first data point and the second data point of the cardiac signal”. Nallathambi discloses replacing the pacing artifact with multiple data points (a k-2, k-1 and k+1 sample) which could be a held value from the k-2 point to zeroed out values (par. [0043]). Nallathambi also discloses a linear interpolation of points between the boundaries can also be made (par. [0044]). Either option shows a “straight line” of points for the replaced artifact, see Fig. 9C and 10C. The rejection is maintained.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 4, 6-8, 11, 12, 16-18, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Nallathambi et al. (2022/0001184) in view of Grievous et al. (5,127,401).
Regarding Claims 1, 11, 12 and 20, Nallathambi discloses a sensing apparatus 200 configured to monitor cardiac electrical activity (ECG) of a patient (Fig. 1, step 10; Fig. 2); a computing apparatus comprising one or more processors (par. [0032, 0051, 0054]; see also PSEEP in Fig. 2) and operatively coupled to the sensing apparatus, the computing apparatus configured to monitor cardiac electrical activity using the sensing apparatus (ECG signals 241 on M sensing channels, par. [0038]); detect a pacing artifact in the cardiac signal (via direct select logic 244 or indirect select logic 245, see par. [0039-0040]); determine to account for the pacing artifact (by actually detecting the pacing artifact) based on at least one pacing artifact characteristic (the pacing artifact is selected based on sample values, e.g. characteristics, of the signal, see par. [0039-0040] and the pacing artifact is accounted for when it is found to exist); accounting for the pacing artifact by removing the artifact from the cardiac signal between a first data point at time T1 and a second data point at time T2; and replacing the removed pacing artifact with replacement data points disposed along a straight line that extends between the first data point and the second data point to provide an optimized signal (once the artifact is identified, a fixed rejection algorithm 262 is executed that removes the artifact between a first point (a k-1 point, which equates to Applicant’s T1) and a second point (a k+ 1 point, which equates to Applicant’s T2) and replaces the artifact with a series of three “fixed” values, such as zero, which would create a straight line, see par. [0043]). While Nallathambi discloses identifying a pacing artifact based on a difference of successive samples of an ECG signal (which implies a change over time, see par. [0039-0040]), Nallathambi fails to go so far as state the artifact is based on a rate of change of the samples. However, Grievous discloses utilizing a derivative of the ECG signal to more accurately determine a pacing artifact (col. 4, lines 1-7). Therefore, 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 device in the Nallathambi reference to include determining a derivative as the comparison threshold for an artifact, as taught and suggested by Grevious, for the purpose of more accurately identifying the pacing artifact.
In regard to Claims 2 and 21, Nallathambi discloses utilizing a bandpass filter prior to detecting the pacing artifact (par. [0032, 0040]).
With regard to Claims 4 and 14, while the Nallathambi and Grievous combination discloses utilizing a derivative, the combination of reference fails to disclose the exact range of 0.1 V/sec to 1000 V/sec. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a derivative threshold of 0.1 V/sec to 1000 V/sec, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Ultimately, a pacing artifact is a spik and the teaching of Grievous discloses identifying a spike based on a rapid rate of change. Identifying the exact magnitude of that derivative would only require routine skill in the art.
With regard to Claims 6, 7, 16 and 17, Nallathambi discloses identifying and replacing the artifact in the signal, thus indicating the position of the artifact is marked and removed from the signal (par. [0043]).
Regarding Claims 8 and 18, Nallathambi discloses sampling the signal at 125Hz which means a sample is taken every 8 ms (1/125). Therefore a time between a first sample (k-1) and a sample two points later (k+1) would be 16 ms, which is within the claimed range.
Claim(s) 3 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nallathambi et al. (2022/0001184) in view of Grievous et al. (5,127,401), further in view of Rowlandson (PGPUB 2023/0346293). Nallathambi discloses utilizing a bandpass filter but fails to disclose the bandwidth of the filter. In the same field of endeavor of cardiac monitoring, Rowlandson discloses utilizing a bandpass filter having a bandwidth between 250 Hz and 15kHz for the purpose of isolating a pacing signal originating from an implantable pacemaker (par. [0050]). Therefore 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 device in the Nallathambi and Grievous combination to include a bandwidth of 250 Hz to 15 kHz for the bandpass filter, as taught and suggested by Rowlandson, for the purpose of isolating a pacing signal originating from an implantable pacemaker.
Furthermore, while the combination of Nallathambi, Grievous and Rowlandson disclose a bandwidth of 250 Hz to 15 kHz and not a smaller range of 400 Hz to 2 kHz, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a range of 400 Hz to 2 kHz, since it has been held that where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 191 USPQ 90.
Claim(s) 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nallathambi et al. (2022/0001184) in view of Grievous et al. (5,127,401), further in view of Babaeizadeh (2022/0000435). Nallathambi and Grievous disclose all of the claimed invention except for sampling the optimized signal with a narrow bandpass filter. However, Babaeizadeh, in the same field of endeavor of ECG signal generation, discloses sampling the ECG signal at the output end with a narrow bandpass filter for the purpose of generating an evenly sampled signal (par. [0078]). Therefore 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 device in the Nallathambi and Grievous combination to include a narrow bandpass filter, as taught and suggested by Babaeizadeh, for the purpose of generating an evenly sampled signal.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Nallathambi et al. (2022/0001184) in view of Grievous et al. (5,127,401), further in view of An et al. (2020/0188677). Nallathambi discloses detecting ECG signals using electrodes of a pacing system but fails to disclose using a housing electrode as one of the sensing electrodes. An shows that ECG sensing from a can electrode is an equivalent structure to lead electrodes that is known in the art (see par. [0060]). Therefore, because lead and can electrode placement for ECG detection were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute the can electrode for the lead electrode in ECG sensing.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Nallathambi et al. (2022/0001184) in view of Grievous et al. (5,127,401), further in view of Engman et al. (2021/0052227). Nallathambi and Grievous disclose all of the claimed invention except for alerting a user to a pacing artifact, which is a corruption or distortion of the signal. However, Engman in the same field of endeavor of cardiac monitoring discloses alerting a user to low quality signals corrupted by artifacts for the purpose of reducing error due to low signal quality and allowing a clinician or user to correct any device errors (par. [0077]). Therefore 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 device in the Nallathambi and Grievous combination to include an alert to a corrupted ECG signal, such as caused by a pacing artifact, as taught and suggested by Engman, for the purpose of reducing error due to low signal quality and allowing a clinician or user to correct any device errors.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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