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 24 April 2026 has been entered. Claims 1 and 15 are currently amended. Claims 3-5 are canceled. Claims 1-2 and 6-15 are pending in the application. Applicant’s amendments to claim 1 have overcome the objection previously set forth in the Non-Final Office Action mailed 28 January 2026.
Claim Objections
Claim 15 is objected to because of the following informalities: in line 22, “then” should read --than--. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “processing module” in claims 1 and 15 and all dependent claims thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The specification discloses that the processing module is formed by electronic circuitry (page 9, lines 18-19).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 6-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sawchuk (US PGPub No. 2009/0299421) in view of Felix (US PGPub No. 2021/0000418), hereinafter Felix.
Regarding claims 1, 6, 10, and 15, Sawchuk teaches 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”).
Sawchuk further teaches a housing (Fig. 7: IMD housing 60) but does not explicitly teach wherein the electrodes are aligned along a longitudinal axis, and axially displaced with respect to one another along the longitudinal axis, 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; and the housing extends along the longitudinal axis, 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 an analogous art, Felix teaches four electrode poles aligned along a longitudinal axis and disposed at first and second ends of a housing extending along the longitudinal axis with electrodes arranged between the ends of the housing, wherein each electrode pairing defines a signal reception vector pointing along the longitudinal axis (Fig. 4: electrodes 19 and 18 arranged at first and second ends of housing 15, with electrodes 23 and 22 arranged between the ends). Felix teaches that providing multiple electrodes aligned along a housing, as disclosed, provides the ability to optimize electrode configurations for acquiring an ECG signal (par. 0049: “An additional pair of ventral ECG electrodes 22, 23 are included on the housing's ventral surface. These ventral ECG electrodes 22, 23 are spaced closer together than the ventral ECG electrodes 18, 19 on the ends of the housing 15 and a physician can thus choose to pair the two inner ventral ECG electrodes 22, 23 by themselves to allow for minimal electrode-to-electrode spacing, or with the other ECG electrodes 16, 17, 18, 19 to vary electrode surface areas, shapes, and inter-electrode spacing even further to explore optimal configurations to acquire the P-wave”). 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 placing first, second, and third electrodes on either end of the housing, the housing and electrodes aligned along the same longitudinal axis, as taught by Felix, in order to provide the ability to optimize electrode configurations for acquiring an ECG signal, as taught by Felix.
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, the combination teaches the device of claim 1 as described previously. Felix further teaches wherein the arrangement contains four or more electrode poles (Fig. 4: four electrodes 18, 19, 22, 23).
Regarding claim 7, the combination teaches the device of claim 1 as described previously. Sawchuk further teaches 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, the combination teaches the device of claim 7 as described previously. Sawchuk further teaches 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 9, the combination teaches the device of claim 7 as described previously. Sawchuk 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.
Regarding claim 11, the combination teaches the device of claim 1 as described previously. Sawchuk further teaches 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, the combination teaches the device of claim 1 as described previously. Sawchuk further teaches 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, the combination teaches the device of claim 1 as described previously. Sawchuk further teaches 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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Sawchuk in view of Felix and further in view of Zaliasl et al. (US PGPub No. 2020/0069206), hereinafter Zaliasl.
Sawchuk in view of Felix teaches 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 the combined reference 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.
Response to Arguments
Applicant’s arguments, filed 24 April 2026, with respect to the rejection(s) of claim(s) 1 and 15 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claims, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Felix. As previously described, Felix teaches three or more electrodes and a housing arranged in alignment with the same longitudinal axis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mazaeva et al. (US PGPub No. 2016/0051159) teaches receiving a plurality of ECG sensing vectors in a plurality of sensing channels that are used to improve signal quality.
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 DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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/D.E.L./ Examiner, Art Unit 3794
/JOANNE M RODDEN/ Supervisory Patent Examiner, Art Unit 3794
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