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 Rejections - 35 USC § 102
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.
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 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nikolski et al. (U.S. Patent Application Publication 2017/0157412).
Regarding claim 1, Nikolski et al. disclose a defibrillator comprising:
a generator device comprising:
a processing circuitry (“processor,” see [0045], [0059], [0060]-[0061], [0078] and figures 5 and 7),and
a shock generation circuitry (“HV charging circuit 240 and a HV charge storage and output module 202 of HV therapy module 83,” see [0078] and figure 7, and alternate/equivalent counterparts in other embodiments), and
at least one lead (“lead 16,” and/or “lead body 18,” see [0025], [0026] and figures 1A-4, and alternate/equivalent counterparts in other embodiments) comprising a shock electrode (one of the “defibrillation electrodes 24A and 24B, collectively 24,” see [0027] and figures 1A-4, and alternate/equivalent counterparts in other embodiments) for emitting electrical shock pulses externally to a patient's heart (“heart 26 of the patient 12,” see [0031] and figures 1A-4),
wherein said processing circuitry is configured to identify a sensed ventricular contraction event (see the incorporation in its entirety of Marshall et al. (2016/0158567) [0040] and [0066] for example) in a sensed electrocardiogram signal or said processing circuitry is configured to control said shock generation circuitry (see [0110]) to generate at least one conditioning pulse (either of pulses “652, 654,” see [0121]-[0129] and figure 12) for emission by said shock electrode to cause an induced ventricular contraction event (see [0005] and [0033] for example),
wherein said processing circuitry is further configured to control said shock generation circuitry to generate a fibrillation pulse for emission by said shock electrode at a delay time () after said sensed or induced ventricular contraction event in order to induce a cardiac fibrillation state(see [0105]).
Regarding claim 2, Nikolski et al. disclose the claimed invention including sensing arrangement (“pace/sense electrodes 28A, 28B,” see [0027] and figures 1A-5) for sensing said electrocardiogram signal.
Regarding claim 3, Nikolski et al. disclose the claimed invention including at least one electrode pole of said sensing arrangement is on said lead (see figures 1A-4).
Regarding claim 4, Nikolski et al. disclose the claimed invention including at least one electrode pole of said sensing arrangement is formed by a housing of said generator device (see figure 5).
Regarding claim 5, Nikolski et al. disclose the claimed invention including the sensing arrangement includes at least three electrode poles (the pair of “pace/sense electrodes 28A and 28B,” and one or more of the “defibrillation electrodes 24A and 24B, collectively 24,” see [0027] and figures 1A-4), the processing circuitry being
configured to sense electrocardiogram signals using different pairs of electrode poles of
said at least three electrode poles.
Regarding claim 6, Nikolski et al. disclose the claimed invention including the processing circuitry is configured to identify at least two subsequent ventricular
contraction events (see [0064], [0105]-[0107] and figure 10) in an electrocardiogram signal, to determine a first interval based on the at least two subsequent ventricular contraction events (see [0064], [0105]-[0107] and figure 10).
Regarding claim 7, Nikolski et al. disclose the claimed invention including the processing circuitry is configured to identify a ventricular contraction event and a subsequent T wave (see [0041]) an electrocardiogram signal, to determine a second
interval based on the ventricular contraction event and the subsequent T wave, and to set said delay time based on the second interval ([see [0041], [0069], [0073]-[0074], and [0110] for example).
Regarding claim 8, Nikolski et al. disclose the claimed invention including the processing circuitry is configured to set said delay time to correspond to a value in a range between 50% and 120% of the second interval (see [0072]-[0073] and [0110]).
Regarding claim 9, Nikolski et al. disclose the claimed invention including the conditioning pulses (see pulses 652 and 654, [0120]-[0123] and figure 12).
Regarding claim 10, Nikolski et al. disclose the claimed invention including the processing circuitry is configured to set said delay time to correspond to a value in a range between 50% and 120% of the conditioning interval (see [0072]-[0073], [0110], and [0120]-[0123]).
Regarding claim 11, Nikolski et al. disclose the claimed invention including the processing circuitry is configured to set said conditioning interval based on a cardiac cycle interval time (so that it will coincide the heat beat of the patient, (see (see [0041], [0069], [0072]-[0073], [0110], and [0120]-[0123]figures 6, and 12).
Regarding claim 12, Nikolski et al. disclose the claimed invention including the
shock generation circuitry comprises a multiplicity of energy storage devices (see the plurality of charge storing branches: 1) a first is the branch from switch 212a to switch 214a for electrode 24a, and 2) a second is the branch from switch 212b to switch 214b for electrode 24b, see [0079]-[0081] and figure 7) and at least one switching device (see switches 206, 212a-212b, and 214a-214b), wherein the processing circuitry is configured to control the at least one switching device to supply energy for generating said fibrillation pulse using all of said multiplicity of energy storage devices or a combination of some of said multiplicity of energy storage devices.
Regarding claim 13, Nikolski et al. disclose the claimed invention including the processing circuitry is configures to control the at least one switching device to supply energy for generating said fibrillation pulse using a first combination of said multiplicity of energy storage devices and to supply energy for generating said at least one
conditioning pulse using a second combination of said multiplicity of energy storage devices different than said first combination (see [0079]-[0087]).
Regarding claim 14, Nikolski et al. disclose the claimed invention including the processing circuitry is configures to control the shock generation circuitry to generate said at least one conditioning pulse using a pulse width modulation (see [0068], [0073], and [0103]).
Regarding claim 15, Nikolski et al. disclose method for operating a non-transvenous implantable cardioverter defibrillator device, said non-transvenous implantable cardioverter defibrillator device comprising a generator device (comprising: A) a processing circuitry (“processor,” see [0045], [0059], [0060]-[0061], [0078] and figures 5 and 7),and B) a shock generation circuitry (“HV charging circuit 240 and a HV charge storage and output module 202 of HV therapy module 83,” see [0078] and figure 7, and alternate/equivalent counterparts in other embodiments) and at least one lead (“lead 16,” and/or “lead body 18,” see [0025], [0026] and figures 1A-4, and alternate/equivalent counterparts in other embodiments) comprising a shock electrode (one of the “defibrillation electrodes 24A and 24B, collectively 24,” see [0027] and figures 1A-4, and alternate/equivalent counterparts in other embodiments) for emitting electrical shock pulses externally to a patient's heart, the method comprising:
identifying, using a processing circuitry of the generator device-sensed ventricular contraction event (see [0064], and [0105]) in a sensed electrocardiogram signal or controlling, using said processing circuitry of the generator device, a shock generation circuitry of the generator device to generate at least one conditioning pulse (see pulse 652 or 654 in figure 12, and/or pulses 502 and 504 in figure 10) for emission by said shock electrode to cause an induced ventricular contraction event , and
controlling, using said processing circuitry, said shock generation circuitry (figure 7) to generate a fibrillation pulse for emission by said shock electrode a delay time after said sensed or induced ventricular contraction event () in order to induce a cardiac fibrillation state (see [0105]-[0106] and figure 10).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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/AARON F ROANE/Primary Examiner, Art Unit 3792