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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/27/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 03/27/2026. As directed by the amendment: Claims 1 and 15 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-,10, and 12-15 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see pages 8-9, filed 03/27/2026, with respect to the rejection(s) of claim(s) 1-15 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. Amendments obviate the rejection of record However, upon further consideration, a new ground(s) of rejection is made in view of Karst et al. (US 20130325081) (IDS) (Hereinafter Karst) in view of Bornzin et al. (US 20130138006)(Hereinafter Bornzin), and McClure (US 6862471)(Hereinafter McClure).
Claim Objections
Claims 1 and 15 are objected to because of the following informalities: the phrase “far-filed activity” in line 17 should be amended to recite “far-field activity”. 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 1-10 and 12-14 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 1 recites the limitation "the second processing signal event" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-10 and 12-14 are rejected for being dependent on claim 1.
Claim Interpretation
Regarding claim 1 and 15, although only the second processing signal is blanked, the blanking window is specified to be done to the second processing channel. This does not exclude that the first processing channel can also be blanked at the same time because the claim is silent to what the first processing channel is doing. Therefore, Examiner interprets a blanking that can occur in both channels simultaneously.
Claim Rejections - 35 USC § 103
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) 1-10 and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karst et al. (US 20130325081) (IDS) (Hereinafter Karst) in view of Bornzin et al. (US 20130138006)(Hereinafter Bornzin), and McClure (US 6862471)(Hereinafter McClure).
Regarding claims 1 and 15, Karst teaches A leadless pacemaker device/Method configured to provide for an intra- cardiac pacing (Abstract “A leadless intra-cardiac medical device senses cardiac activity from multiple chambers and applies cardiac stimulation”), the leadless pacemaker device comprising:
a housing (Fig. 1(104));
an electrode arrangement arranged on the housing and configured to receive electrical signals ([0044] “The LIMD 102 also uses the electrodes 106 and 108 for sensing cardiac activity. For example, in some implementations, the electrode 106 is used for acquiring near-field signals while the electrode 108 is used for acquiring far-field signals.”); and
a processing circuitry enclosed in the housing and operatively connected to the electrode arrangement (Fig. 7 (702, 704, 706) Fig. 1(110)), wherein the processing circuitry comprises a first processing channel having a first gain for processing a first processing signal derived from electrical signals received via the electrode arrangement ([0128] “The sensing circuits 1344 and 1346, in turn, receive control signals over signal lines 1348 and 1350, respectively, from the microcontroller 1320 for purposes of controlling the gain” Examiner asserts that the ventricular sensing circuit 1346 has its own gain for the near-field signal, and does not need to be increased in gain as the implantable device in implanted in the ventricle. This can be seen in [0080] where the high amplitude R wave of the near-field signal is contrasted with the increased gain of the far-field signal.) and a second processing channel having a second gain for processing a second processing signal derived from electrical signals received via the electrode arrangement, the second gain being higher than the first gain ([0080] “In contrast, the far-field P wave will have an amplitude that does not exceed an upper threshold, since it is recorded as a far-field signal. The gain of the sensing circuitry [using sensing circuitry 1344 may be increased to resolve signals having lower amplitude, with the R wave allowed to go out of range.” [0128] “The sensing circuits 1344 and 1346, in turn, receive control signals over signal lines 1348 and 1350, respectively, from the microcontroller 1320 for purposes of controlling the gain” [0075] “As an example of the latter scenario, the circuitry used for sensing for the P wave may be set to high gain to enable the relatively small P wave to be detected from the far-field signals.” Examiner asserts that the ventricular sensing circuit 1346 has its own gain for the near-field signal, and does not need to be increased in gain as the implantable device in implanted in the ventricle, thereby having a higher gain for the far-field signal compared to the near-field signal. This can be seen in [0080] where the high amplitude R wave of the near-field signal is contrasted with the increased gain of the far-field signal.)
wherein the second processing channel comprises a processing stage configured to, apply to the second processing signal, a blanking window (Tblank) ([0122] “Microcontroller 1320 [processing stage] further includes … keep track of the timing of refractory periods, blanking intervals, noise detection windows, evoked response windows, alert intervals, marker channel timing, etc., as known in the art.”);
wherein the second processing channel comprises an amplification stage for amplifying the second processing signal, wherein the amplification stage is switched off during said blanking window ([0087] “The sensing circuits 842 and 844 define the NF and FF channels, respectively. The sensing circuits 842 and 844 are activated and deactivate by the control signals 848 and 846, from the controller 820. The sensing circuits 842 and 844 are activated during sensing windows by the controller 820 based on timing parameters that may be programmed by a physician and/or by a device manufacturer.”).
Karst further teaches an amplification stage ([0127]) for each processing channel. However, Karst does not teach second processing channel comprises a processing stage configured to apply, only to the second processing signal, a blanking window (Tblank) for excluding only a portion of the second processing signal event from further processing. Bornzin, in the same field of endeavor, teaches a leadless intra-cardiac medical device with near-field and far-field channels for collecting NF and FF signals (Abstract), similar to the device of Karst, and further teaches wherein the second processing channel comprises a processing stage configured to apply, only to the second processing signal, a blanking window (Tblank) for excluding only a portion of the second processing signal event from further processing ([0074] “During the AV blanking interval of segment 648, the sensing circuits are deactivated which corresponds to the time period of propagation of activity from the atrium to the ventricle (e.g. the AV delay). The segment 648 corresponds to the PR timer set at 528 in FIG. 5A.” AV blanking periods blank both the FF and NF channels, specifically the R peaks of the FF signal. As noted in the claim interpretation section, the claim does not mention not blanking the NF channel.); wherein the second processing channel comprises an amplification stage for amplifying the second processing signal, wherein the amplification stage is switched off during said blanking window ([0074] “During the AV blanking interval of segment 648, the sensing circuits are deactivated which corresponds to the time period of propagation of activity from the atrium to the ventricle (e.g. the AV delay). The segment 648 corresponds to the PR timer set at 528 in FIG. 5A.” AV blanking periods blank both the FF and NF channels, specifically the R peaks of the FF signal. As noted in the claim interpretation section, the claim does not mention not blanking the NF channel.) to collect signal information from the desired output ([0075]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Karst, with the second processing channel comprises a processing stage configured to apply, only to the second processing signal, a blanking window (Tblank) for excluding only a portion of the second processing signal event from further processing of Bornzin, because such a modification would allow to collect signal information from the desired output.
However, Karst does not teach the portion comprising QRS waves and T waves, so as to permit passage through the second processing channel, and further processing, of signals representative of far-filed activity. McClure, in the same field of endeavor, teaches the blanking interval for near-field and far-field signals. Although McClure is directed to a combipolar sensing system and not two separate NF and FF channels, Karst and McClure strengthen the detection of signals for better viewing (Col. 2 lines 28-42). McClure further teaches the portion comprising QRS waves and T waves, so as to permit passage through the second processing channel, and further processing, of signals representative of far-filed activity (Col. 3 lines 66-67 “blanking schemes may be used to blank T-waves from the atrial channel to prevent such T-waves from being falsely sensed as P-waves.” See Fig. 5 with PVAB (QRS blanking) and T wave blanking.) to derive a more accurate atrial rate (Col. 5 lines 1-2). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Karst, with the portion comprising QRS waves and T waves, so as to permit passage through the second processing channel, and further processing, of signals representative of far-filed activity of McClure, because such a modification would allow to derive a more accurate atrial rate.
Regarding claim 2, Karst teaches wherein the housing comprises a tip , the electrode arrangement comprising a first electrode placed on the tip - for engaging with intra-cardiac tissue ([0070] “a microprocessor of the processing circuit 706 may be configured to acquire intra-cardiac electrogram data” [0118] “a right ventricular tip terminal (V.sub.R TIP) and a right ventricular ring terminal (V.sub.R RING) are adapted for connection to a right ventricular tip electrode 1312 and a right ventricular ring electrode 1314, respectively.”).
Regarding claim 3, Karst teaches wherein the electrode arrangement comprises a second electrode formed by an electrode ring circumferentially extending about the housing and being placed at a distance from said tip ([0118] “a right ventricular tip terminal (V.sub.R TIP) and a right ventricular ring terminal (V.sub.R RING) are adapted for connection to a right ventricular tip electrode 1312 and a right ventricular ring electrode 1314, respectively.” See Fig. 2 where ring electrodes are at a distance from tip electrodes).
Regarding claim 4, Karst teaches wherein the processing circuitry is configured to process, as said first and/or second processing signal, a first and/or second signal sensed between the first electrode and the second electrode ([0044] “the electrode 106 is used for acquiring near-field signals while the electrode 108 is used for acquiring far-field signals.”).
Regarding claim 5, Karst teaches wherein the housing comprises a far end opposite the tip, the electrode arrangement comprising a third electrode arranged in the vicinity of the far end ([0107] “To facilitate far-field sensing, an electrode spacing of approximately 1 centimeter may be employed between the second electrode and a third electrode.” Fig. 2 and 4’s very left side is the far end of the housing.).
Regarding claim 6, Karst teaches wherein the processing circuitry is configured to process, as said first and/or second processing signal, a first and/or second signal sensed between the first electrode and the third electrode ([0107] “sensing via the first set of electrodes may primarily detect the near-field signals (e.g., the sensed far-field signals may be very small). In addition, sensing via the second set of electrodes may detect both the near field signals and the far-field signals (e.g., separated by an atrial-ventricular delay period)”).
Regarding claim 7, Karst teaches wherein the processing circuitry is configured to process the first processing signal to detect a ventricular activity and the second processing signal to detect an atrial activity ([0106] “sensing via the two electrodes may detect both near-field signals and far-field signals (e.g., separated by an atrial-ventricular delay period).” [0103] “atrial events are identified based on the sensed near-field signals.” [0104] “ventricular events are identified based on the sensed far-field signals.”).
Regarding claim 8, Karst teaches wherein the processing stage is further configured to differentiate one wave portion from another wave portion in the second processing signal ([0130] “Timing intervals between sensed events [differentiating different wave portions from one another] (e.g., P-waves, R-waves, and depolarization signals associated with fibrillation) may be classified by the arrhythmia detector 1334 of the microcontroller 1320 by comparing them to a predefined rate zone limit (e.g., bradycardia, normal, low rate VT, high rate VT, and fibrillation rate zones) and various other characteristics (e.g., sudden onset, stability, physiologic sensors, and morphology, etc.)” and [0081]).
Regarding claim 9, Karst teaches wherein the processing stage is further configured to apply, to the second processing signal, at least one of a bandpass filtering, a moving average filtering, a finite difference filtering, and a rectification ([0127] “Each sensing circuit 1344 and 1346 preferably employs one or more low power, precision amplifiers with programmable gain, automatic gain control, bandpass filtering, a threshold detection circuit, or some combination of these components, to selectively sense the cardiac signal of interest.”).
Regarding claim 10, Karst teaches wherein the first processing channel comprises a first detection stage for detecting at least one near-field event in the first processing signal, wherein the processing stage of the second processing channel is configured to determine at least one limit of the blanking window (Tblank) for excluding a portion of the second processing signal from further processing based on at least one near-field event detected by said first detection stage ([0081] “timing window filtering is used to exclude the T wave. Whenever an R wave is identified or a ventricular pulse is delivered, any activity following it is assumed to be the effect of ventricular repolarization. As an example, consider a leadless pacemaker set to pace the RV at a rate of 60 bpm. The window size for searching for a P wave may be set to an interval of 300-1000 ms after the prior R wave or V pacing pulse. If a P wave is detected in that window, the leadless pacemaker waits for the programmed AV interval to find an intrinsic R wave, before timing out and delivering a V pacing pulse. If a P wave does not occur in that window, the leadless pacemaker assumes that a P wave will not happen, and delivers a V pacing pulse at 1000 milliseconds.” [0127] “Each sensing circuit 1344 and 1346 preferably employs one or more low power, precision amplifiers with programmable gain, automatic gain control, bandpass filtering, a threshold detection circuit, or some combination of these components, to selectively sense the cardiac signal of interest.” Examiner notes that the time between 0-300 ms is excluded).
Regarding claim 12, Karst teaches wherein the second processing channel comprises a second detection stage for detecting at least one far-field event in the second processing signal ([0104] “ventricular events are identified based on the sensed far-field signals.” [0126] “ventricular sensing circuits 1346”).
Regarding claim 13, Karst teaches wherein the second detection stage is configured to detect said at least one far-field event by at least one of
- comparing the second processing signal to a threshold, and evaluating at least one morphological feature of the second processing signal, wherein the evaluating of at least one morphological feature includes at least one of determining an amplitude value from the second processing signal,
- determining a duration of a wave portion of the second processing signal ([0078] “an R wave and/or a P wave was detected within a defined window of time. In particular, stimulation is delivered to the ventricle if an R wave does not occur within a window of time after a P wave.”),
- determining a number of threshold crossings or zero crossings in the second processing signal, and
- determining a location of a wave portion in a detection window ([0130] “Timing intervals between sensed events (e.g., P-waves, R-waves, and depolarization signals associated with fibrillation) may be classified by the arrhythmia detector 1334 of the microcontroller 1320 by comparing them to a predefined rate zone limit (e.g., bradycardia, normal, low rate VT, high rate VT, and fibrillation rate zones) and various other characteristics (e.g., sudden onset, stability, physiologic sensors, and morphology, etc.)”).
Regarding claim 14, Karst teaches wherein the processing circuitry is configured to trigger a pacing signal based on at least one detected far-field event ([0121] “ventricular pulse generator 1324 that generate pacing stimulation pulses for delivery by the right atrial electrodes, the right ventricular electrode” [0135] “the microcontroller 1320 responds by adjusting the various pacing parameters (such as rate, A-V Delay, V-V Delay, etc.) at which the atrial and ventricular pulse generators 1322 and 1324 generate stimulation pulses.”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
McClure (US 6862471) teaches a PVARP blanking period for removing far-field R and T waves (Col.3 lines 52-65 and Fig. 1) but fails to teach that the atrial amplifier is turned off during PVARP blanking period.
Nappholz (US 5312445) is extracting far-field P waves from the near-field channel as the blanking is being done to the ventricular channel, which is near-field, which is different than what is being claimed since the blanking is occurring only in the far-field channel
Florio (US 6477416) teaches an atrial near-field signal where the far-field ventricular signals are interference signals that are blanked out.
Lybarger (US 11786739) teaches a PAVB that blanks far-field atrial signal interference for the near-field channel’s near-field signal.
Hoberman (US 7437190) teaches multiple PVAB intervals for blanking far-field ventricular signal for obtaining the near-field atrial signal of the near-field channel.
McClure (US 6650931) teaches the identifying of near-field R and T waves on the ventricular (near-field) channel and identify far-field atrial waves for blanking, including R and T waves.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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