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 Amendment
The amendment filed December 11, 2025 has been entered. Claims 1-5, 9, 17 have been amended. Claims 6-8, 10-16, 18 were previously withdrawn. Currently, claims 1-5, 9, 17 are pending for examination.
Response to Arguments
Applicant’s arguments, see p. 6-8, filed December 11, 2025, with respect to 35 U.S.C. 101 have been fully considered and are persuasive. The 35 U.S.C. 101 rejection of claims 1-5, 9 and 17 has been withdrawn.
Applicant’s arguments, see pages 8-10, filed December 11, 2025, with respect to the rejection(s) of claim(s) 1-5, 9 and 17 under 35 U.S.C. 102 or 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of an alternative interpretation of Gunderson et al. (2017/0128734) in view of Hareland et al. (US 2014/0379039).
Regarding the new interpretation of Gunderson et al., the claim limitation of, “determine in real time whether each individual interval is a non-physiological short interval (NPSI)” is now considered as detecting the NST episode 304 (fig. 4; [0061]) in view of the current amendments. This differs from the previous Office action, where the NST episode was regarded as meeting the claimed language of “evaluating the electrogram signal for a series of sensed events”.
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.
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.
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.
Claim(s) 1, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (2017/0128734) in view of Hareland et al. (US 2014/0379039).
Regarding claim 1, Gunderson et al. discloses an automated method of identifying a lead system condition of an implantable lead system 200 operably positioned to transmit signals from one or more chambers of the heart of a patient and operably coupled to a cardiac implantable electrical device 214 for sensing that is operably coupled to the implantable lead system (fig. 3), the automated method comprising: implanting the implantable lead system ([0021]), wherein the implantable lead system comprises at least one heart lead 212, 216, 218 placed in operable communication with the one or more chambers of the heart (fig. 3), control circuitry comprising a data interpreter 86 in operable communication with the heart via the at least one heart lead, a data store 82 in operable communication with the data interpreter, a microcontroller 80 in operable communication with the data store, and a transceiver 88 in operable communication with the microcontroller (fig. 2); providing a device 40 in operable communication with the transceiver ([0051]; fig. 1), wherein the control circuitry is configured to: sense electrogram signals from an electrode pair in which at least one electrode is on the implantable lead system ([0028]; “sensed cardiac electrical signals received from sensing circuit 86” [0060]); evaluate the electrogram signal for a series of sensed events (“cardiac events… R-wave events… P-wave events” [0060]); for each individual interval between successive sensed events (“control module 80 determines intervals between cardiac events” [0060]), determine in real time whether each individual interval is a non-physiological short interval (NPSI) 304 (fig. 4; “event intervals may be compared to a tachyarrhythmia detection interval threshold for detecting tachyarrhythmia intervals… A sensed event interval shorter than the tachyarrhythmia interval is counted as a tachyarrhythmia interval. NST detection criteria may be satisfied when a minimum number of tachyarrhythmia intervals is reached without reaching the required number of intervals to detect a sustained tachyarrhythmia episode” [0061]), and if so: determine if the NPSI is a more-specific NPSI 306, 314 (fig. 4; “In response to detecting an NST episode at block 304, control module 80 may analyze the sensed event intervals during the NST episode at block 306 to determine whether the NST is likely caused by oversensing” [0063]; “after the NST episode is detected and determined to meet the lead related oversensing criteria at block 308, further analysis of the cardiac electrical signal acquired during the NST episode is performed at block 314 to rule out the presence of non-lead related oversensing” [0068]; “the analysis performed at block 314 for identifying whether an NST is caused by non-lead related oversensing may be performed each time an NST episode is detected and the NST. In this example, blocks 314 and 316 may be performed prior to blocks 310 and 312” [0068] -contrary to applicant’s arguments in the latest response, no storage of NPSI episodes is required) on a measure of a first sensed electrogram signal of the sensed electrogram signals in a first analysis window corresponding to the sensed event that begins the NPSI, and a second sensed electrogram signal of the sensed electrogram signals in a second analysis window corresponding to the sensed event that ends the NPSI (“control module 80 may analyze the sensed event intervals during the NST episode… the sensed event intervals during the NST episode may be analyzed by determining at least one event interval metric and comparing the event interval metric(s) to an oversensing criteria” [0063] -all the event intervals determined to be in the NST episode are analyzed including the first and second sensed electrogram signals); and once a predetermined number of more-specific NPSIs have been identified within a predetermined monitoring period, generate a lead system condition alert 322 (“lead integrity alert (LIA)” [0016]; [0072]) to the device 40 that is in operable communication with the transceiver ([0031]).
Gunderson et al. does not expressly disclose the determining if the NPSI (“NST” [0061]) is a more-specific NPSI (“oversensing” [0063]; “rule out the presence of non-lead related oversensing” [0068]) is based on a measure of the frequency content of the first sensed electrogram signal and the second sensed electrogram signal. Hareland et al. teaches oversensing is generally associate with multiple oversensed events per cardiac cycle that may be intermittent or continuous and of relatively low or high frequency ([0057]), such as the frequency content of the noisy signal 50 within the electrogram signal (fig. 4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson et al. to determine if the NPSI is a more-specific NPSI through the measure of the frequency content of the first sensed electrogram signal and the second sensed electrogram signal as taught by Hareland et al. as it is a known technique to improve similar oversensing detecting cardiac devices, such a device yielding predictable results.
Regarding claim 17, Gunderson et al. discloses wherein the control circuitry is within the cardiac implantable electrical device and the sensed first and second electrogram signals are analyzed by the control circuitry in real-time once the NPSI is determined (“In response to detecting an NST episode at block 304, control module 80 may analyze the sensed event intervals during the NST episode at block 306 to determine whether the NST is likely caused by oversensing” [0063]; “after the NST episode is detected and determined to meet the lead related oversensing criteria at block 308, further analysis of the cardiac electrical signal acquired during the NST episode is performed at block 314 to rule out the presence of non-lead related oversensing” [0068]; “the analysis performed at block 314 for identifying whether an NST is caused by non-lead related oversensing may be performed each time an NST episode is detected and the NST. In this example, blocks 314 and 316 may be performed prior to blocks 310 and 312” [0068]).
Claim(s) 2-4, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (2017/0128734) in view of Hareland et al. (US 2014/0379039) and further in view of Gunderson et al. (US 2017/0042482; hereinafter “Gunderson et al. ‘482”).
Regarding claim 2, Gunderson et al. does not expressly disclose wherein the first sensed electrogram signal and/or the second sensed electrogram signal is determined to be a high-frequency electrogram signal by the control circuitry if a measure of a frequency content of the first sensed electrogram signal and/or the sensed second electrogram signal exceeds a first predetermined threshold and a low-frequency electrogram signal if a measure of a frequency content of the first sensed electrogram signal is less than a second predetermined threshold, and/or if a measure of a frequency content of the second sensed electrogram signal is less than the second predetermined threshold. Gunderson et al. ‘482 teaches oversensing of noise spikes due to a lead issue could negatively impact effective detection of cardiac signals ([0034]) and to detect medical electrical lead issues using a spike detector where event intervals of sensed electrogram signals ([0057]) are analyzed to determine if a measure of a frequency content (“spike detect signals” [0058]) are greater or less than a predetermined threshold (“threshold number of lead issue spikes” [0083], [0095]; “time interval”[0098-0100]; [0103]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson et al. to implement a spike detector for the first or second sensed electrogram signals as taught by Gunderson et al. ‘482 to provide a specific process of detecting noise-related frequency content in electrogram signals in order to more effectively determine when the electrogram indicates a medical lead issue, the results of such a modification being reasonably predictable.
Regarding claim 3, Gunderson et al. in view of Gunderson et al. ‘482 disclose the NPSI is determined by the control circuitry to be a more-specific NPSI (fig. 4; “In response to detecting an NST episode at block 304, control module 80 may analyze the sensed event intervals during the NST episode at block 306 to determine whether the NST is likely caused by oversensing” [0063]; “after the NST episode is detected and determined to meet the lead related oversensing criteria at block 308, further analysis of the cardiac electrical signal acquired during the NST episode is performed at block 314 to rule out the presence of non-lead related oversensing” [0068]; “the analysis performed at block 314 for identifying whether an NST is caused by non-lead related oversensing may be performed each time an NST episode is detected and the NST. In this example, blocks 314 and 316 may be performed prior to blocks 310 and 312” [0068]) if: at least one of the first or second sensed electrogram signals is a high-frequency electrogram (Gunderson et al. ‘482 “threshold number of lead issue spikes” [0083], [0095]; “time interval”[0098-0100]; [0103]); or both of the first and second sensed electrogram signals are not low-frequency electrograms.
Regarding claim 4, Gunderson et al. discloses a NPSI is analyzed to be a more-specific NPSI only if: further processing is performed by the control circuitry on both the first and second sensed electrogram signals with or without processing of additional electrogram signals; and this processing does not identify a cause of the NPSI unrelated to a lead system condition ([0068-0071]).
Regarding claim 9, Gunderson et al. in view of Gunderson et al. ‘482 disclose the measure of the frequency content is a direct measure of frequency content (“spike detect signals” [0058]) of the first and/or second sensed electrogram signals ([0057]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (2017/0128734) in view of Hareland et al. (US 2014/0379039) and Gunderson et al. (US 2017/0042482; hereinafter “Gunderson et al. ‘482”) and further in view of Atwater et al. (US 2020/0254248).
Regarding claim 5, the limitations directed to the “additional electrogram signals” is referencing what was introduced in claim 4. Given claim 4’s alternative recitation of “with or without processing of additional electrogram signals and related intervals”, this “additional electrogram signals” may not need to be given patentable weight. However if given patentable weight, Gunderson et al. discloses the additional electrogram signals and related intervals correspond temporally to the first and second analysis windows of the NPSI ([0068-0070]) but does not expressly disclose they are sensed from one or more electrode pairs on one or more conductors in the lead system that are different from the electrode pair that is sensing the first and second sensed electrogram signals. Atwater et al. teaches it is known in the art to use multiple electrode pairs ([0068]) when detecting EGM signals ([0077]) in case a lead issue occurs ([0056]), and for providing a more thorough depiction of EGM data ([0076-0077]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson et al. to use multiple pairs of electrodes to determine electrogram signals as taught by Atwater et al. in order to provide a more thorough depiction of EGM data and to provide alternative pairs of sensing when a lead issue occurs ([0056]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796