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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 11524169. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and the US Patent claim the same inventive concept of charge-balanced pacing from a shock-capable capacitor via HV switching. The US Patent does claim use of the switching circuitry to couple the HV capacitor to pacing vectors and deliver charge-balanced pulses, specifying that some switches are current-latching devices that require a hold current and that you ensure at least that current flows during discharge is predictable design choice making the current application an obvious variant.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12005263. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and the US Patent claim the same inventive concept of charge-balanced pacing from a shock-capable capacitor via HV switching. The US Patent does claim use of the switching circuitry to couple the HV capacitor to pacing vectors and deliver charge-balanced pulses, specifying that some switches are current-latching devices that require a hold current and that you ensure at least that current flows during discharge is predictable design choice making the current application an obvious variant.
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.
Claim(s) 1-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson et al. (US 20170157414).
Regarding claim 1, Anderson discloses a high voltage therapy circuit (section 0019, delivering cardiac pacing pulses using high-voltage therapy circuitry and implanted, extra-cardiovascular electrodes) comprising: a capacitor chargeable to a shock voltage amplitude for delivering a cardioversion/defibrillation shock pulse (section 0059, includes high-voltage (HV) circuitry capable of delivering energy large enough to cardiovert/defibrillate a patient's heart. The HV circuitry of therapy delivery module 84 includes one or more high voltage capacitors); and an output circuit 202 comprising at least one switch 212a-c that is closed by a minimum current (Fig. 8, Section 0070, the high-voltage pacing configuration by control module 80 may include setting a variable shunt resistance for delivering at least a minimum electrical current to switches included in the HV switching circuitry of therapy delivery module 84 to maintain desired switches in an active or closed state during a pacing pulse); a control circuit 14 configured to control the high voltage therapy circuit to: charge the capacitor to a pacing voltage amplitude that is less than the shock voltage amplitude (section 0060, he HV capacitor may be charged to 40 V or less, 30 V or less, or 20 V or less for producing extra-cardiovascular pacing pulses. In most instances, the HV circuitry is generally designed for delivery of the high-voltage CV/DF shocks which are typically associated with voltages that are much higher than the 40 V, 30V, or 20V); and deliver a first pacing pulse having a first polarity, wherein delivering the first pacing pulse comprises: delivering at least the minimum current through the output circuit to hold the at least one switch closed (section 0082, To deliver a biphasic pulse using electrode 24a and housing 15, for instance, switch 212a and 214c may be closed to deliver a first phase of the biphasic pulse); and discharging the capacitor charged to the pacing voltage amplitude through the output circuit to deliver the first pacing pulse (sections 0008, 0069, 0081, configuring the switching circuitry to discharge the high voltage capacitor across the pacing load to deliver the one or more pacing pulses via the extra-cardiovascular electrodes. The HV capacitor charged to the pulse voltage amplitude 72 continues to be discharged for the remaining portion 70b of pacing pulse width 74. When control module 80 determines that delivery of an electrical stimulation pulse from HV circuitry 83 is needed, switching circuitry 204 is controlled by signals from processor and HV therapy control module 230 to electrically couple HV capacitor 210 to a therapy delivery vector to discharge capacitor 210 across the vector selected from electrodes 24a, 24b and/or housing).
Regarding claim 2, Anderson discloses control the high voltage therapy circuit to deliver a second pulse after the first pacing pulse, the second pulse having a second polarity opposite the first polarity, the second pulse balancing an electrical charge delivered during the first pacing pulse (Section 0069, 0075, Switching circuitry of therapy delivery module 84 may controlled to reverse the polarity of the delivered pulse during capacitor discharging to produce the biphasic pulse. The polarity may be reversed at a given voltage threshold in some examples. top-off charging may be enabled up to one second prior to delivering a pacing pulse, or upon anticipating a need for delivering a pacing pulse, which may be the first pacing pulse of a series of pulses delivered for capture threshold testing).
Regarding claim 3, Anderson discloses the high voltage therapy circuit is further configured to deliver at least the minimum current through the output circuit to hold the at least one switch closed to deliver the second pulse (Section 0075, 0089, top-off charging may be enabled up to one second prior to delivering a pacing pulse, or upon anticipating a need for delivering a pacing pulse, which may be the first pacing pulse of a series of pulses delivered for capture threshold testing. Switches 212a-212c and switches 214a-214c may require a minimum current flow to hold them closed (i.e., ON or enabled) for passing current as capacitor 210 is discharged).
Regarding claim 4, Anderson discloses deliver the first pacing pulse having a first leading voltage amplitude 72 corresponding to the pacing voltage amplitude; terminate the first pacing pulse, the first pacing pulse having a trailing voltage (Fig. 6 voltage portion after 70a, similar to applicants Fig. 8B disclosed in section 0113) upon the termination; and deliver the second pulse having a second leading voltage amplitude (Fig. 6 voltage portion before 70b, similar to applicants Fig. 8B disclosed in section 0113) corresponding to the trailing voltage.
Regarding claim 5, Anderson discloses the control circuit is further configured to start a pacing interval upon delivery of the first pacing pulse by the high voltage therapy circuit (section 0075, Section 0075, 0089, top-off charging may be enabled up to one second prior to delivering a pacing pulse, or upon anticipating a need for delivering a pacing pulse, which may be the first pacing pulse of a series of pulses delivered for capture threshold testing); and the high voltage therapy circuit is further configured to: deliver the first pacing pulse having a first leading voltage amplitude corresponding to the pacing voltage amplitude (section 0074, the leading edge voltage of the HV pacing pulses may not be increased above the capture threshold amplitude during pacing, but the large pulse width safety margin used in this case provides a high likelihood of successfully capturing the heart); and deliver the second pulse after the pacing interval, the second pulse having a second leading voltage amplitude corresponding to the pacing voltage amplitude (Fig. 6 voltage portion before 70b, similar to applicants Fig. 8B disclosed in section 0113).
Regarding claim 6, Anderson discloses the high voltage therapy circuit is further configured to: deliver the first pacing pulse having a first tilt (Fig. 6, shows the 70a start at 10v and drop/tilt to around 7/7.5 volts, similar to Fig. 8A of applicant specification); and deliver the second pulse having a second tilt different than the first tilt (Fig. 6 shows 70b start at -5.5/6V and drop/tilt to -5 volts, similar to Fig. 8A of applicant specification).
Regarding claim 7, Anderson discloses determine a delivered energy of the first pacing pulse (he threshold test for the high-voltage pacing configuration includes delivering pacing pulses having a minimum or default pulse width (e.g., 2 ms) at a starting pulse amplitude, which may be a minimum voltage amplitude the therapy delivery module 84 is capable of delivering e.g., 10 V in this example); and determine the second tilt based on the delivered energy of the first pacing pulse (Fig. 6 shows 70b start at -5.5/6V and drop/tilt to -5 volts, similar to Fig. 8A of applicant specification).
Regarding claim 8, Anderson discloses current shunting circuitry 250, 252, the high voltage therapy circuit being further configured to deliver at least the minimum current by shunting a portion of at least the minimum current through the current shunting circuitry (Fig. 8, section 0092, a minimum voltage charge of capacitor 210 may be set to provide the minimum current required to maintain an enabled state of selected switches of switching circuitry 204, but pacing energy may be intentionally shunted away from the pacing load including heart 26 in order to reduce the delivered pacing pulse energy).
Regarding claim 9, Anderson discloses impedance measurement circuitry 90 configured to measure a pacing load impedance (section 0065, control module 80 may use the impedance measurement to set a variable shunt resistance included in HV circuitry of therapy delivery module 84 when a pacing configuration is selected for delivering extra-cardiovascular pacing pulses to heart 26. The variable shunt resistance may be parallel to the pacing load and set to be equal to or less than the pacing load impedance to maintain electrical current through HV switching circuitry throughout the duration of a pacing pulse delivered by the therapy delivery module 84 thereby promoting an appropriate voltage signal across the pacing load for capturing the patient's heart); and the current shunting circuitry comprises a variable shunt resistance 250, 252 (section 0090, The shunt resistance 250 or 252 may be a variable resistance that is set to match a pacing electrode vector impedance so that the load across heart 26 using a selected pacing electrode vector matches the shunt resistance); and the high voltage therapy circuit being further configured to: set the variable shunt resistance based on a pacing load measured by the impedance measurement circuitry; and deliver at least the minimum current through the output circuit by shunting the portion of at least the minimum current through the variable shunt resistance (section 0065, 0091 control module 80 may use the impedance measurement to set a variable shunt resistance included in HV circuitry of therapy delivery module 84 when a pacing configuration is selected for delivering extra-cardiovascular pacing pulses to heart 26. The variable shunt resistance may be parallel to the pacing load and set to be equal to or less than the pacing load impedance to maintain electrical current through HV switching circuitry throughout the duration of a pacing pulse delivered by the therapy delivery module 84 thereby promoting an appropriate voltage signal across the pacing load for capturing the patient's heart. processor and HV therapy control module 230 may be configured to retrieve a pacing electrode vector impedance measurement from impedance measurement module 90 and set the shunt resistance 250 (or 252) to match the pacing electrode vector impedance).
Regarding claim 10, Anderson discloses a pacing load current flows through the output circuit when the capacitor is discharged for delivering the first pacing pulse (Section 0089, Switches 212a-212c and switches 214a-214c may require a minimum current flow to hold them closed (i.e., ON or enabled) for passing current as capacitor 210 is discharged); and the high voltage therapy circuit is further configured to deliver at least the minimum current to be greater than the pacing load current (section 0097, If the minimum charge voltage of capacitor 210 required to maintain a minimum electrical current applied to enable switches of switching circuitry 204 is greater than the pacing amplitude capture threshold, the variable shunt resistance 250 may be adjusted to a resistance that is less than the pacing load impedance).
Regarding claim 11, Anderson discloses charging a capacitor to a pacing voltage amplitude, the capacitor being chargeable to a shock voltage amplitude for delivering a cardioversion/defibrillation shock pulse, the pacing voltage amplitude being less than the shock voltage amplitude (section 0060, he HV capacitor may be charged to 40 V or less, 30 V or less, or 20 V or less for producing extra-cardiovascular pacing pulses. In most instances, the HV circuitry is generally designed for delivery of the high-voltage CV/DF shocks which are typically associated with voltages that are much higher than the 40 V, 30V, or 20V); and delivering a first pacing pulse having a first polarity, wherein delivering the first pacing pulse comprises: delivering at least a minimum current through an output circuit to hold at least one switch of the output circuit closed (section 0082, To deliver a biphasic pulse using electrode 24a and housing 15, for instance, switch 212a and 214c may be closed to deliver a first phase of the biphasic pulse); and discharging the capacitor charged to the pacing voltage amplitude through the output circuit to deliver the first pacing pulse (sections 0008, 0069, 0081, configuring the switching circuitry to discharge the high voltage capacitor across the pacing load to deliver the one or more pacing pulses via the extra-cardiovascular electrodes. The HV capacitor charged to the pulse voltage amplitude 72 continues to be discharged for the remaining portion 70b of pacing pulse width 74. When control module 80 determines that delivery of an electrical stimulation pulse from HV circuitry 83 is needed, switching circuitry 204 is controlled by signals from processor and HV therapy control module 230 to electrically couple HV capacitor 210 to a therapy delivery vector to discharge capacitor 210 across the vector selected from electrodes 24a, 24b and/or housing).
Regarding claim 12, Anderson discloses control the high voltage therapy circuit to deliver a second pulse after the first pacing pulse, the second pulse having a second polarity opposite the first polarity, the second pulse balancing an electrical charge delivered during the first pacing pulse (Section 0069, 0075, Switching circuitry of therapy delivery module 84 may controlled to reverse the polarity of the delivered pulse during capacitor discharging to produce the biphasic pulse. The polarity may be reversed at a given voltage threshold in some examples. top-off charging may be enabled up to one second prior to delivering a pacing pulse, or upon anticipating a need for delivering a pacing pulse, which may be the first pacing pulse of a series of pulses delivered for capture threshold testing).
Regarding claim 13, Anderson discloses the high voltage therapy circuit is further configured to deliver at least the minimum current through the output circuit to hold the at least one switch closed to deliver the second pulse (Section 0075, 0089, top-off charging may be enabled up to one second prior to delivering a pacing pulse, or upon anticipating a need for delivering a pacing pulse, which may be the first pacing pulse of a series of pulses delivered for capture threshold testing. Switches 212a-212c and switches 214a-214c may require a minimum current flow to hold them closed (i.e., ON or enabled) for passing current as capacitor 210 is discharged).
Regarding claim 14, Anderson discloses deliver the first pacing pulse having a first leading voltage amplitude 72 corresponding to the pacing voltage amplitude; terminate the first pacing pulse, the first pacing pulse having a trailing voltage (Fig. 6 voltage portion after 70a, similar to applicants Fig. 8B disclosed in section 0113) upon the termination; and deliver the second pulse having a second leading voltage amplitude (Fig. 6 voltage portion before 70b, similar to applicants Fig. 8B disclosed in section 0113) corresponding to the trailing voltage.
Regarding claim 15, Anderson discloses the control circuit is further configured to start a pacing interval upon delivery of the first pacing pulse by the high voltage therapy circuit (section 0075, Section 0075, 0089, top-off charging may be enabled up to one second prior to delivering a pacing pulse, or upon anticipating a need for delivering a pacing pulse, which may be the first pacing pulse of a series of pulses delivered for capture threshold testing); and the high voltage therapy circuit is further configured to: deliver the first pacing pulse having a first leading voltage amplitude corresponding to the pacing voltage amplitude (section 0074, the leading edge voltage of the HV pacing pulses may not be increased above the capture threshold amplitude during pacing, but the large pulse width safety margin used in this case provides a high likelihood of successfully capturing the heart); and deliver the second pulse after the pacing interval, the second pulse having a second leading voltage amplitude corresponding to the pacing voltage amplitude (Fig. 6 voltage portion before 70b, similar to applicants Fig. 8B disclosed in section 0113).
Regarding claim 16, Anderson discloses the high voltage therapy circuit is further configured to: deliver the first pacing pulse having a first tilt (Fig. 6, shows the 70a start at 10v and drop/tilt to around 7/7.5 volts, similar to Fig. 8A of applicant specification); and deliver the second pulse having a second tilt different than the first tilt (Fig. 6 shows 70b start at -5.5/6V and drop/tilt to -5 volts, similar to Fig. 8A of applicant specification).
Regarding claim 17, Anderson discloses determine a delivered energy of the first pacing pulse (he threshold test for the high-voltage pacing configuration includes delivering pacing pulses having a minimum or default pulse width (e.g., 2 ms) at a starting pulse amplitude, which may be a minimum voltage amplitude the therapy delivery module 84 is capable of delivering e.g., 10 V in this example); and determine the second tilt based on the delivered energy of the first pacing pulse (Fig. 6 shows 70b start at -5.5/6V and drop/tilt to -5 volts, similar to Fig. 8A of applicant specification).
Regarding claim 18, Anderson discloses current shunting circuitry 250, 252, the high voltage therapy circuit being further configured to deliver at least the minimum current by shunting a portion of at least the minimum current through the current shunting circuitry (Fig. 8, section 0092, a minimum voltage charge of capacitor 210 may be set to provide the minimum current required to maintain an enabled state of selected switches of switching circuitry 204, but pacing energy may be intentionally shunted away from the pacing load including heart 26 in order to reduce the delivered pacing pulse energy).
Regarding claim 19, Anderson discloses impedance measurement circuitry 90 configured to measure a pacing load impedance (section 0065, control module 80 may use the impedance measurement to set a variable shunt resistance included in HV circuitry of therapy delivery module 84 when a pacing configuration is selected for delivering extra-cardiovascular pacing pulses to heart 26. The variable shunt resistance may be parallel to the pacing load and set to be equal to or less than the pacing load impedance to maintain electrical current through HV switching circuitry throughout the duration of a pacing pulse delivered by the therapy delivery module 84 thereby promoting an appropriate voltage signal across the pacing load for capturing the patient's heart); and the current shunting circuitry comprises a variable shunt resistance 250, 252 (section 0090, The shunt resistance 250 or 252 may be a variable resistance that is set to match a pacing electrode vector impedance so that the load across heart 26 using a selected pacing electrode vector matches the shunt resistance); and the high voltage therapy circuit being further configured to: set the variable shunt resistance based on a pacing load measured by the impedance measurement circuitry; and deliver at least the minimum current through the output circuit by shunting the portion of at least the minimum current through the variable shunt resistance (section 0065, 0091 control module 80 may use the impedance measurement to set a variable shunt resistance included in HV circuitry of therapy delivery module 84 when a pacing configuration is selected for delivering extra-cardiovascular pacing pulses to heart 26. The variable shunt resistance may be parallel to the pacing load and set to be equal to or less than the pacing load impedance to maintain electrical current through HV switching circuitry throughout the duration of a pacing pulse delivered by the therapy delivery module 84 thereby promoting an appropriate voltage signal across the pacing load for capturing the patient's heart. processor and HV therapy control module 230 may be configured to retrieve a pacing electrode vector impedance measurement from impedance measurement module 90 and set the shunt resistance 250 (or 252) to match the pacing electrode vector impedance).
Regarding claim 20, Anderson discloses a pacing load current flows through the output circuit when the capacitor is discharged for delivering the first pacing pulse (Section 0089, Switches 212a-212c and switches 214a-214c may require a minimum current flow to hold them closed (i.e., ON or enabled) for passing current as capacitor 210 is discharged); and the high voltage therapy circuit is further configured to deliver at least the minimum current to be greater than the pacing load current (section 0097, If the minimum charge voltage of capacitor 210 required to maintain a minimum electrical current applied to enable switches of switching circuitry 204 is greater than the pacing amplitude capture threshold, the variable shunt resistance 250 may be adjusted to a resistance that is less than the pacing load impedance).
Regarding claim 21, Anderson discloses charge a capacitor to a pacing voltage amplitude, the capacitor being chargeable to a shock voltage amplitude for delivering a cardioversion/defibrillation shock pulse, the pacing voltage amplitude being less than the shock voltage amplitude (section 0060, he HV capacitor may be charged to 40 V or less, 30 V or less, or 20 V or less for producing extra-cardiovascular pacing pulses. In most instances, the HV circuitry is generally designed for delivery of the high-voltage CV/DF shocks which are typically associated with voltages that are much higher than the 40 V, 30V, or 20V); and deliver a pacing pulse, wherein delivering the pacing pulse comprises: delivering at least a minimum current through an output circuit of the medical device to hold at least one switch of the output circuit closed (section 0082, To deliver a biphasic pulse using electrode 24a and housing 15, for instance, switch 212a and 214c may be closed to deliver a first phase of the biphasic pulse); and discharging the capacitor charged to the pacing voltage amplitude through the output circuit to deliver the pacing pulse (sections 0008, 0069, 0081, configuring the switching circuitry to discharge the high voltage capacitor across the pacing load to deliver the one or more pacing pulses via the extra-cardiovascular electrodes. The HV capacitor charged to the pulse voltage amplitude 72 continues to be discharged for the remaining portion 70b of pacing pulse width 74. When control module 80 determines that delivery of an electrical stimulation pulse from HV circuitry 83 is needed, switching circuitry 204 is controlled by signals from processor and HV therapy control module 230 to electrically couple HV capacitor 210 to a therapy delivery vector to discharge capacitor 210 across the vector selected from electrodes 24a, 24b and/or housing).
Conclusion
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796