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 arguments filed 1/6/2026 have been fully considered but they are not persuasive.
Applicant argues Carney merely detects capture by identifying an R-wave or morphology, not a determination based on one or more capture criteria comprising amplitude and/or duration threshold comparisons, as recited in amended claim 1. Further, comparison of ECG signal's amplitude to an amplitude threshold or comparison of ECG signal's duration to a duration threshold for the purpose of determining capture is distinct from using sensing thresholds to identify P-waves or R-waves. The examiner respectfully disagrees as the Applicant highlighted in the recitation of Paragraph [0099] that P-wave sense event signals and R-wave sense event signals are passed to cardiac signal analyzer 90 when the ECG signal crosses a respective P-wave sensing threshold and R-wave sensing threshold (emphasis added). Therefore the signal first has to have an amplitude sufficient to cross a respective P-wave/R-wave sensing threshold which is then passed to the cardiac signal analyzer for further analysis of capture. The examiner notes the claim uses the transitional phrase “comprising”. MPEP 2111.03 discloses the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). Therefore, the arguments are not persuasive.
Claim Interpretation
The examiner notes the 112(f) in the office action dated 10/6/2025 that “energy output device” is considered a capacitor as described in published paragraph [0005] or a system of capacitors or a ultracapacitor as disclosed in paragraph [0075].
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 22 and 24 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.
The term “about” in claim 22 and 24 renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear when the metes and bounds of the claim would fall outside the term “about 20 milliseconds” for example would 15 milliseconds be considered about 20 milliseconds? Or would 1 millisecond be considered about 20 milliseconds?
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 30 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 30 requires the processor is configured to detect presence or absence of an evoked response to determine whether the pacing pulse was captured. However, independent clam 21 identifies “determine whether the pacing pulse was captured by determining whether the ECG signal, within a window subsequent to a blanking period and a refractory period following delivery of the pacing pulse, meets one or more capture criteria, the one or more capture criteria comprising at least one of a comparison of an amplitude of the ECG signal to an amplitude threshold, and a comparison of a duration of the ECG signal to a duration threshold”. It appears that claims 30 is either changing the way that the determination of capture is occurring ( using evoked response) or broadening the independent claim to include an additional mechanism for the determination of capture. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-3, 6, and 21-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Whiting et al (US Publication 2019/0262608) in view of Sullivan et al (US Publication 2018/0184933), Levine (US Patent 6,430,441), Holstrom et al (US Publication 2010/0099994) and Carney et al (US Publication 2015/0321011).
Referring to Claim 1, Whiting et al teaches a wearable medical system, comprising: a support structure configured to be worn by a patient (e.g. Figure 1, Element 110 and Paragraph [0053]); a plurality of electrocardiogram (ECG) electrodes to sense an ECG signal of the patient (e.g. Figure 1, Elements 112 and Figure 3, Element 326 and 328); an energy interface (e.g. Figure 3, Element 302 and Paragraphs [0091] and [0094] discloses comprises coupling capacitors to the processor); a plurality of therapy electrodes engaged to the support structure and in communication with the output circuit, to deliver therapy to the patient (e.g. Figure 1, Element 114a and 114b and Figure 3, Elements 330-338); and a processor, in communication with the plurality of ECG electrodes and the output circuit, (e.g. Figure 3, processor 318) configured to: cause a pacing pulse to be delivered to the patient via the energy output device, the output circuit, and the plurality of therapy electrodes (e.g. Paragraph [0052]), determine whether the pacing pulse was captured by determining whether the ECG signal, meets one or more capture criteria (e.g. Paragraph [0175] discloses the cardiac monitor records capture information, e.g., checks to see if there is pacing pulse capture), responsive to a determination that the pacing pulse was captured, prevent an additional pacing pulse from being delivered to the patient, and responsive to a determination that the pacing pulse was not captured, cause an additional pacing pulse to be delivered to the patient. Whiting et al does not explicitly disclose the energy output interface comprises an energy output device to store electrical charge and an output circuit coupled to the energy output device; determining captured within a window subsequent to a blanking period and a refractory period following the delivery of the pacing pulse; the one or more capture criteria comprising at least one of a comparison of an amplitude of the ECG signal to an amplitude threshold, and a comparison of a duration of the ECG signal to a duration threshold; and responsive to a determination that the pacing pulse was captured, prevent an additional pacing pulse from being delivered to the patient, and responsive to a determination that the pacing pulse was not captured, cause an additional pacing pulse to be delivered to the patient. Sullivan et al teaches that it is known to use an energy storage module (250) and an output circuit (255) connected to a processor, the energy storage module, and therapy electrodes as set forth in Figure 2 and Paragraphs [0035], [0048], and [0049] to provide sufficient energy for delivery of therapy to terminate arrhythmias. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Whiting et al, with an energy storage module and an output circuit connected to a processor, the energy storage module, and therapy electrodes as taught by Sullivan et al, since such a modification would provide the predictable results of sufficient energy for delivery of therapy to terminate arrhythmias.
Levine teaches that it is known to use a capture window of 46ms after an absolute refractory period during which blanking occurs, the alert period is which evoked responses are detectable as set forth in Column 13 lines 42-55 to provide improved identification of intrinsic beats and reducing the risk of confusion that the pacing pulse is part of an intrinsic signal. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Whiting et al, with determining captured within a window subsequent to a blanking period and a refractory period following the delivery of the pacing pulse as taught by Levine, since such a modification would provide the predictable results of improved identification of intrinsic beats and reducing the risk of confusion that the pacing pulse is part of an intrinsic signal. Holmstrom et al teaches that it is known to deliver back-up pulses if a heart chamber is not captured when a pacing pulse has been delivered as set forth in Paragraph [0063] to provide additional support to the heart when necessary to stimulate a beat. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Whiting et al, with deliver back-up pulses if a heart chamber is not captured when a pacing pulse has been delivered as taught by Holmstrom et al, since such a modification would provide the predictable results of additional support to the heart when necessary to stimulate a beat.
Carney et al teaches that it is known to use one or more capture criteria comprise an ECG amplitude threshold and a duration threshold, and wherein the duration threshold is met when an ECG amplitude measured within the window is above the ECG amplitude threshold for a predetermined minimum amount of time as set forth in Paragraphs [0190]-[0191] (detecting R-wave) and Paragraph [0099] to provide improved detection if capture occurred and the heart is intrinsically beating. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Whiting et al, with the one or more capture criteria comprising at least one of a comparison of an amplitude of the ECG signal to an amplitude threshold, and a comparison of a duration of the ECG signal to a duration threshold as taught by Carney et al, since such a modification would provide the predictable results of improved detection if capture occurred and the heart is intrinsically beating.
Referring to Claims 2 and 23, the modified Whiting et al teaches the claimed invention except wherein the duration threshold is met when the amplitude of the ECG signal measured within the window is above the ECG amplitude threshold for a predetermined minimum amount of time. Carney et al teaches that it is known to use one or more capture criteria comprise an ECG amplitude threshold and a duration threshold, and wherein the duration threshold is met when an ECG amplitude measured within the window is above the ECG amplitude threshold for a predetermined minimum amount of time as set forth in Paragraphs [0190]-[0191] (detecting R-wave) and Paragraph [0099] to provide improved detection if capture occurred and the heart is intrinsically beating. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Whiting et al, with wherein the duration threshold is met when the amplitude of the ECG signal measured within the window is above the ECG amplitude threshold for a predetermined minimum amount of time as taught by Carney et al, since such a modification would provide the predictable results of improved detection if capture occurred and the heart is intrinsically beating.
Referring to Claim 3, the modified Whiting et al teaches the wearable medical system of claim 1, wherein the plurality of ECG electrodes are ECG electrodes (e.g. Paragraph [0053] discloses using various ECG electrodes). However, Whiting et al does not explicitly disclose resistive and direct current (DC)-coupled ECG electrodes.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Whiting et al, with a resistive and direct current (DC)-coupled ECG electrodes since it was known in the art that resistive and direct current (DC)-coupled ECG electrodes is used to provide the predictable results of receiving ECG data from various parts of the patient’s body.
Referring to Claims 6 and 25, the modified Whiting et al teaches the claimed invention, further comprising a user interface (e.g. Figure 2, display 220 and speaker 204, and Figure 3, Element 308) configured to alert bystanders through audio and/or visual alerts of at least one of the pacing pulse being delivered to the patient and a pacing capture status (e.g. Paragraph [0101] discloses user interface may provide an alarm indicting that the patient has experienced an arrhythmia and is being paced).
Referring to Claim 21, Whiting et al teaches a defibrillator comprising: a plurality of electrocardiogram (ECG) electrodes to sense an ECG signal of the patient (e.g. Figure 1, Elements 112 and Figure 3, Element 326 and 328); an energy interface (e.g. Figure 3, Element 302 and Paragraphs [0091] and [0094] discloses comprises coupling capacitors to the processor); a plurality of therapy electrodes to deliver therapy to the patient (e.g. Figure 1, Element 114a and 114b and Figure 3, Elements 330-338); a processor, in communication with the plurality of ECG electrodes (e.g. Figure 3, processor 318) configured to: cause a pacing pulse to be delivered to the patient via the energy output device, and the plurality of therapy electrodes (e.g. Paragraph [0052]), determine whether the pacing pulse was captured by determining whether the ECG signal, meets one or more capture criteria (e.g. Paragraph [0175] discloses the cardiac monitor records capture information, e.g., checks to see if there is pacing pulse capture), responsive to a determination that the pacing pulse was captured, prevent an additional pacing pulse from being delivered to the patient, and responsive to a determination that the pacing pulse was not captured, cause an additional pacing pulse to be delivered to the patient. Whiting et al does not explicitly disclose the energy output interface comprises an energy output device to store electrical charge; determining captured within a window subsequent to a blanking period and a refractory period following delivery of the pacing pulse; the one or more capture criteria comprising at least one of a comparison of an amplitude of the ECG signal to an amplitude threshold, and a comparison of a duration of the ECG signal to a duration threshold; and responsive to a determination that the pacing pulse was captured, prevent an additional pacing pulse from being delivered to the patient, and responsive to a determination that the pacing pulse was not captured, cause an additional pacing pulse to be delivered to the patient. Sullivan et al teaches that it is known to use an energy storage module (250) and an output circuit (255) connected to a processor, the energy storage module, and therapy electrodes as set forth in Figure 2 and Paragraphs [0035], [0048], and [0049] to provide sufficient energy for delivery of therapy to terminate arrhythmias. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Whiting et al, with an energy storage module and an output circuit connected to a processor, the energy storage module, and therapy electrodes as taught by Sullivan et al, since such a modification would provide the predictable results of sufficient energy for delivery of therapy to terminate arrhythmias.
Levine teaches that it is known to use a capture window of 46ms after an absolute refractory period during which blanking occurs, the alert period is which evoked responses are detectable as set forth in Column 13 lines 42-55 to provide improved identification of intrinsic beats and reducing the risk of confusion that the pacing pulse is part of an intrinsic signal. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Whiting et al, with determining captured within a window subsequent to a blanking period and a refractory period following the delivery of the pacing pulse as taught by Levine, since such a modification would provide the predictable results of improved identification of intrinsic beats and reducing the risk of confusion that the pacing pulse is part of an intrinsic signal. Holmstrom et al teaches that it is known to deliver back-up pulses if a heart chamber is not captured when a pacing pulse has been delivered as set forth in Paragraph [0063] to provide additional support to the heart when necessary to stimulate a beat. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Whiting et al, with deliver back-up pulses if a heart chamber is not captured when a pacing pulse has been delivered as taught by Holmstrom et al, since such a modification would provide the predictable results of additional support to the heart when necessary to stimulate a beat.
Carney et al teaches that it is known to use one or more capture criteria comprise an ECG amplitude threshold and a duration threshold, and wherein the duration threshold is met when an ECG amplitude measured within the window is above the ECG amplitude threshold for a predetermined minimum amount of time as set forth in Paragraphs [0190]-[0191] (detecting R-wave) and Paragraph [0099] to provide improved detection if capture occurred and the heart is intrinsically beating. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Whiting et al, with the one or more capture criteria comprising at least one of a comparison of an amplitude of the ECG signal to an amplitude threshold, and a comparison of a duration of the ECG signal to a duration threshold as taught by Carney et al, since such a modification would provide the predictable results of improved detection if capture occurred and the heart is intrinsically beating.
Referring to Claim 22, the modified Whiting et al teaches the defibrillator of claim 21, wherein the blanking period is about 20 milliseconds to about 80 milliseconds (e.g. Levine Column 13 lines 42-55 teaches a 14 ms absolute refractory period during which time the sense amplifier 84 is blanked from looking for evoked responses).
However, the modified Whiting et al does not explicitly disclose he blanking period is about 20 milliseconds to about 80 milliseconds. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by the modified Whiting with the blanking period is about 20 milliseconds to about 80 milliseconds, 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] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Referring to Claim 24, the modified Whiting et al teaches the defibrillator of claim 21, except wherein the amplitude threshold is set between a range from about 20uV to about 300 uV, and the duration threshold is set between a range from about 20ms to about 200ms.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by the modified Whiting et al with the amplitude threshold is set between a range from about 20uV to about 300 uV, and the duration threshold is set between a range from about 20ms to about 200ms, 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] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Referring to Claim 26, the modified Whiting et al teaches the defibrillator of claim 21, wherein the pacing pulse is delivered to the patient responsive to detecting a cardiac condition (e.g. Paragraphs [0006], [0260] and [0262] disclose capture management pacing is used to treat bradycardia).
Referring to Claim 27, the modified Whiting et al teaches the defibrillator of claim 26, wherein the cardiac condition is bradycardia or asystole (e.g. Paragraphs [0006], [0260] and [0262]).
Referring to Claim 28, the modified Whiting et al teaches the defibrillator of claim 21, wherein the additional pacing pulse is delivered with same pacing parameters as the pacing pulse (e.g. Holmstrom et al Paragraph [0063] discloses a back-up pulse).
Referring to Claim 29, the modified Whiting et al teaches the defibrillator of claim 21, wherein the additional pacing pulse is a back-up pacing pulse or an incremental pacing pulse (e.g. Holmstrom et al Paragraph [0063]).
Referring to Claim 30, the modified Whiting et al teaches the defibrillator of claim 21, wherein the processor is configured to detect presence or absence of an evoked response to determine whether the pacing pulse was captured (e.g. Paragraph [0175] or Levine Column 13 lines 42-55).
Claim(s) 4-5 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Whiting et al (US Publication 2019/0262608) in view of Sullivan et al (US Publication 2018/0184933), Levine (US Patent 6,430,441), Holstrom et al (US Publication 2010/0099994) and Carney et al (US Publication 2015/0321011), as applied to claim 1 above, and further in view of Hedberg et al (US Publication 2004/0193226).
Referring to Claims 4-5 and 31, the modified Whiting et al teaches the claimed invention, except wherein the blanking period is implemented by a finite impulse response filter; and wherein the finite impulse response filter continues filtering ECG signals during an electrical artifact period.
Hedberg et al teaches that it is known to use a pacing system with a blanking period is implemented by a finite impulse response filter; and wherein the finite impulse response filter continues filtering ECG signals during an electrical artifact period as set forth in Figures 4 and 7 to provide an improved technique for detecting evoked responses in a reliable way for pacing (e.g. Paragraph [0007]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Whiting et al, with blanking period is implemented by a finite impulse response filter; and wherein the finite impulse response filter continues filtering ECG signals during an electrical artifact period as taught by Hedberg et al, since such a modification would provide the predictable results of improved technique for detecting evoked responses in a reliable way for pacing.
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 William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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/William J Levicky/Primary Examiner, Art Unit 3796