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 1 is objected to because of the following informalities: in line 15, “then” should read --than--. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 6-8, and 10-13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sawchuk (US PGPub No. 2009/0299421).
Regarding claims 1, 6, 10, and 15, Sawchuk discloses an implantable medical device for sensing physiological signals (Fig. 1: IMD 16; par. 0042: “Leads 18, 20, 22 extend into the heart 12 of patient 16 to sense electrical activity of heart 12”), comprising:
an arrangement of at least a first electrode pole, a second electrode pole and a third electrode pole, said arrangement of at least the first electrode pole, the second electrode and the third electrode pole being configured to sense physiological signals (Fig. 4A, 7: electrodes 40, 42, 44, 46, 48, 50, 58, 62, 64, 66; par. 0133: “IMD 16 may sense an evoked cardiac signal using a sensing vector including electrode 50 of lead 22 and electrode 40 of lead 18, indicated by arrow 72. In still other examples, electrode 58 of IMD housing 60 may be included as an electrode in a unipolar sensing vector, e.g., unipolar sensing vectors including electrode 58 and any one of electrodes 40, 42, 44, 46, 48, 50, 62, 64, and 66”);
and a processing module for processing signals received via said arrangement of at least the first electrode pole, the second electrode pole and the third electrode pole (Figs. 4A-4B: processor 80);
wherein the processing module is configured to monitor cardiac activity based on a first signal received by a first pair of electrode poles of the arrangement of at least the first electrode pole, the second electrode and the third electrode pole, wherein said first pair of electrode poles is formed by the first electrode pole and the second electrode pole (par. 0133: “For example, IMD 16 may sense an evoked cardiac signal using a sensing vector including electrode 58 of IMD housing 60 and electrode 64 of lead 20, as indicated by arrow 73”);
and to assess a consistency of said first signal based on a second signal received by a second pair of electrode poles of the arrangement of at least the first electrode pole, the second electrode and the third electrode pole different than said first pair, wherein the processing module is configured to assess said consistency of the first signal based on a comparison of the first signal and the second signal (par. 0142: “multiple sensing vectors may be used to sense the same evoked cardiac signal. [...] IMD 16 or programmer 24 may analyze the evoked signals obtained by multiple sense vectors with respect to one another. In particular, IMD 16 or programmer 24 may compare data from different sensing vectors to determine whether sensed events are consistent across the vectors and, therefore, reliable, or whether one or more vectors has produced data that may be unreliable and indicative of a sensing or lead integrity condition for the respective vector”).
Claim 15 is rejected for the same reasons as claim 1, since it merely recites method steps for performing the configured processing steps recited in claim 1.
Regarding claim 2, Sawchuk discloses the device of claim 1 as described previously. Sawchuk further discloses wherein the arrangement contains four or more electrode poles (Figs. 4A-4B and 7: electrodes 40, 42, 44, 46, 48, 50, 58, 62, 64, 66).
Regarding claims 3-4, Sawchuk discloses the device of claim 1 as described previously. Sawchuk further discloses wherein the electrode poles are arranged aligned along a longitudinal axis (Fig. 7: electrodes 58, 64, 44, 46 aligned along longitudinal axis of lead 20) and wherein the first electrode pole and the second electrode pole define a first signal reception vector therebetween pointing along the longitudinal axis, the second electrode pole and the third electrode pole define a second signal reception vector therebetween pointing along the longitudinal axis, and the first electrode pole and the third electrode pole define a third signal reception vector therebetween pointing along the longitudinal axis (par. 0134: “a sensing vector may include electrodes of different types, e.g., a sensing vector including ring electrode 44 and helix tip electrode 46, or ring electrode 44 and elongated coil electrode 64, or can electrode 58 and coil electrode 62 or 64”).
Regarding claim 7, Sawchuk discloses the device of claim 1 as described previously. Sawchuk further discloses wherein the processing module is configured to process said first signal in a first processing channel and said second signal in a second processing channel (Figs. 4A-4B: sensing module 86 and processor 80; par. 0083: “sensing module 86 includes one or more sensing channels, each of which may comprise an amplifier, as described above. In response to the signals from processor 80, the switch module within sensing module 86 may couple the outputs from the selected electrodes to one of the sensing channels”).
Regarding claim 8, Sawchuk discloses the device of claim 7 as described previously. Sawchuk further discloses wherein the processing module is configured to perform, in said first processing channel and/or in said second processing channel, at least one of an amplification and an analog-to-digital conversion (par. 0087: “sensing module 86 includes a channel that comprises an amplifier with a relatively wider pass band than the R-wave or P-wave amplifiers. Signals from the selected sensing electrodes that are selected for coupling to this wide-band amplifier may be provided to a multiplexer, and thereafter converted to multi-bit digital signals by an analog-to-digital converter (ADC)”).
Regarding claim 11, Sawchuk discloses the device of claim 1 as described previously. Sawchuk further discloses wherein the processing module is configured, for assessing said consistency of the first signal, to assess at least one of a signal summation of said first signal and said second signal, a signal difference between said first signal and said second signal, and a signal relation of said first signal and said second signal (par. 0142: “IMD 16 or programmer 24 may compare data from different sensing vectors to determine whether sensed events are consistent across the vectors and, therefore, reliable, or whether one or more vectors has produced data that may be unreliable and indicative of a sensing or lead integrity condition for the respective vector;” examiner interprets comparing data from different sensing vectors as assessing a signal relation of first and second signals).
Regarding claim 12, Sawchuk discloses the device of claim 1 as described previously. Sawchuk further discloses wherein the processing module is configured, for assessing said consistency of the first signal, said consistency of the first signal, to evaluate said second signal for detection of at least one cardiac event in the second signal (par. 0119: “Sensing module 86 may be configured as a narrow-band sensing module or wide-band sensing module, and may be configured to sense particular portions of an evoked signal, such as evoked Q, R or S waves, or other wave characteristics of an evoked signal;” par. 0143: “The analysis of the sensed cardiac signal may include comparing one or more properties exhibited by the sensed signal to the properties expected to be exhibited by a signal sensed by one or more reliable leads”).
Regarding claim 13, Sawchuk discloses the device of claim 1 as described previously. Sawchuk further discloses wherein the processing module is configured to assess said consistency of the first signal in case a signal loss is detected in said first signal or in case an asystole or a cardiac fibrillation is detected in said first signal (par. 0143: “If the comparison indicates one or more differences between the sensed cardiac signal and the signal expected from one or more reliable leads, the determination may be made based on the analysis that the one or more implantable leads are not reliable”). Examiner notes that as the limitations of this claim are stated in the alternative, the claim is considered to be met when only one of the limitations is met.
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sawchuk in view of Cao et al. (US PGPub No. 2016/0144190), hereinafter Cao.
Sawchuk discloses the device of claim 1 as described previously. Sawchuk further teaches a housing (Fig. 7: IMD housing 60) but does not explicitly teach wherein the first electrode pole is arranged at a first end of the housing, the second electrode pole is arranged at a second end of the housing opposite the first end, and the third electrode pole and/or any further electrode pole is arranged at a location in between said first end and said second end.
However, in a related implantable cardiac device art, Cao teaches an implantable medical device with three housing-based electrodes, the first and second electrodes arranged at first and second ends of the housing, respectively, and a third electrode between the first and second ends (Fig. 3B: housing 22’, housing-based electrodes 26, 27, 28), which allows multiple sensing vectors to be evaluated without transvenous leads (par. 0004: “An intracardiac pacemaker may carry electrodes directly on the housing of the pacemaker and eliminate the need for transvenous leads;” par. 0051: “Housing 22′ may carry three electrodes 26, 27 and 28 to provide multiple sensing vectors”). 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 of Sawchuk by providing second and third electrodes on the housing, as taught by Cao, in order to provide multiple sensing vectors without using the leads, as taught by Cao.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sawchuk.
Sawchuk teaches the device of claim 7 as described previously but does not explicitly teach wherein the processing module is configured to synchronously process said first signal in said first processing channel and said second signal in said second processing channel. However, in light of Sawchuk’s own teaching that multiple signal vectors can be sensed simultaneously, as an explicitly alternative to non-simultaneous processing (par. 0166: “IMD 16 may be configured to obtain the sensed evoked signals for different sensing vectors at a regular or irregular sampling rate. Evoked signals may be sensed substantially simultaneously using different sensing vectors. Alternatively, each sensing vector may have a dedicated sampling time that is independent of other sensing vectors”), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the processor of Sawchuk to synchronously process the first and second signals in the first and second processing channels, respectively.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Sawchuk in view of Zaliasl et al. (US PGPub No. 2020/0069206), hereinafter Zaliasl.
Sawchuk discloses the device of claim 1 as described previously. Sawchuk further teaches identifying an inconsistency in a signal (par. 0132: “FIG. 7 illustrates various sensing vectors that may be utilized by IMD 16 to evaluate sensing integrity;” par. 0141: “IMD 16 or programmer 24 may evaluate the individual vectors to determine whether a lead-related condition or other sensing integrity condition may exist”) but does not explicitly teach wherein the processing module is configured, in case an inconsistency in said first signal is identified, to monitor cardiac activity based on another signal received by a pair of electrode poles of the arrangement of the first electrode pole, the second electrode and the third electrode pole other than said first pair. However, in an analogous art, Zaliasl teaches a bioelectrical monitoring system with a processing module configured to select a pair of electrodes providing a higher quality signal over a pair of electrodes providing a lower quality signal, which allows the system to continuously provide a reliable output signal (par. 0026: “when it is identified that a different pair of electrodes may provide a higher quality signal, the other multiplexer and signal processing unit may also be activated while the presently active signal processing unit continues to provide a digital representation of the selected signal. When the signal from the newly activated signal processing unit has been allowed to settle, a signal output by the system may be switched in order to continuously provide a high quality signal, while the pair of electrodes used for acquiring the signal is changed. Thereafter, the multiplexer and signal processing unit connected to a signal of low quality may be turned off. Thus, the system may be configured to continuously provide a reliable output signal to be further analyzed”). 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 of Sawchuk by configuring the processor to choose a pair of electrodes providing a higher quality signal, as taught by Zaliasl, in order to continuously provide a reliable output signal, as taught by Zaliasl.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794