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 .
Specification
The disclosure is objected to because of the following informalities:
REFERENCE TO RELATED APPLICATIONS should reference the issued U.S. Patent 11,964,160 B2 for U.S. Patent Application No. 17/370,303. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 10-15 and 21 is/are rejected under 35 U.S.C. 102(a)(1/(a)(2) as being anticipated by Hermann (US 20190201698 A1).
Re. claim 1, Hermann teaches a medical device system (abstract – “A medical system includes…”) comprising:
a pulse generator (figure 1, IMD 104),
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configured to deliver bipolar pacing pulses via a cathode electrode and an anode electrode (abstract – “…His-bundle pacing (HBP) pulses…”; paragraph 0068 – “…the electrostimulation circuit 220 may be configured to deliver bipolar HBP, where the stimulation energy is applied between two electrodes at or near the His bundle…”; paragraph 0105 – “…an extended bipolar HBP vector may consist of a first electrode (e.g., a cathode) selected from the electrodes 112A-112B associated with the first lead 106 and a second electrode (e.g., an anode) selected from the proximal electrodes 131A-131B associated with the second lead 107”);
a sensing circuit configured to sense a first unipolar cardiac electrical signal from the anode electrode (paragraph 0078 – “…the left-ventricular sensing circuit 216 may sense a unipolar LV EGM between an LV electrode…”);
and processing circuitry (figure 2, cardiac pacing system 200) configured to:
receive at least the first unipolar cardiac electrical signal sensed by the sensing circuit from the anode electrode following at least one bipolar pacing pulse delivered by the pulse generator having a first pacing pulse output (paragraph 0078 – “…the left-ventricular sensing circuit 216 may sense a unipolar LV EGM between an LV electrode…”);
detect, from the first unipolar cardiac electrical signal, anodal capture by the at least one bipolar pacing pulse having the first pacing pulse output (paragraph 0078 – “…the capture verification circuit 232 may determine the His-bundle capture status using a morphology of an LVS event. The morphology may be extracted from an LV EGM Examples of the morphological features may include a QRS width, a slope of the upstroke or down-stroke branch of the R wave, or an area under the QRS curve, among others”);
and select a bipolar bundle branch pacing pulse output in response to detecting the anodal capture (paragraph 0105 – “The HBP pulse may be generated according to one or more HBP stimulation strength parameters including, for example, a pulse amplitude, a pulse width, a pulse frequency, a pulse waveform, a duty cycle, or a stimulation duration”),
and the pulse generator being further configured to deliver bipolar pacing pulses according to the selected bundle branch pacing pulse output (paragraph 0112 – “If at 660 a His-bundle capture is indicated, then the process may continue at 620 to detect AS event and deliver triggered HBP”; paragraph 0105 – “The HBP pulse may be delivered in a unipolar, bipolar, extended polar, or tripolar configuration, among others”).
Re. claim 2, Hermann further teaches the pulse generator is further configured to deliver the bipolar pacing pulses at a plurality of pacing pulse outputs comprising the first pacing pulse output (figure 6 shows steps 630 and 670 of delivering HBP and LVP pulses, respectively which can be delivered repeatedly and with bipolar configurations; paragraph 0070 – “Bipolar LVP refers to an application of stimulation energy between two electrodes positioned at or near the LV epicardium or endocardium…”; paragraph 0105 – “The HBP pulse may be delivered in a unipolar, bipolar, extended polar, or tripolar configuration, among others”);
the processing circuitry is further configured to:
determine an anodal capture threshold based on at least the first unipolar cardiac electrical signal sensed by the sensing circuit via the anode electrode when the bipolar pacing pulses delivered by the pulse generator at the plurality of pacing pulse outputs (paragraph 0075 – “…the capture verification circuit 232 may decide that a His bundle capture (selective or non-selective) has occurred if the Hp-LV interval falls below a threshold (HV.sub.TH)…”);
and select the bundle branch pacing pulse output based on the anodal capture threshold (paragraph 0086 – “In various examples, the control circuit 230 may include a pacing threshold test circuit (not shown) configured to determine a pacing threshold representing minimal energy required to excite the His bundle”).
Re. claim 3, Hermann further teaches wherein the processing circuitry is further configured to select the bundle branch pacing pulse output based on detecting the anodal capture by selecting the bundle branch pacing pulse output to be at least the anodal capture threshold (paragraph 0086 – ““In various examples, the control circuit 230 may include a pacing threshold test circuit (not shown) configured to determine a pacing threshold representing minimal energy required to excite the His bundle…The HBP control circuit 235 may adjust one or more stimulation parameters using the determined pacing threshold”).
Re. claim 4, Hermann further teaches wherein the processing circuitry is further configured to select the bundle branch pacing pulse output based on detecting the anodal capture by selecting the bundle branch pacing pulse output to be less than the first pacing pulse output (paragraph 0086 – “The threshold test may include delivering HBP pulses (e.g., via the electrostimulation circuit 220) at or near the His bundle in accordance with a threshold test protocol that defines varying a stimulation parameter at a specified manner, such as ramping up or ramping down the pulse amplitude”).
Re. claim 5, Hermann further teaches wherein the processing circuitry is further configured to select the bundle branch pacing pulse output based on detecting the anodal capture by selecting the bundle branch pacing pulse output to be at least the first pacing pulse output (paragraph 0086 – ““In various examples, the control circuit 230 may include a pacing threshold test circuit (not shown) configured to determine a pacing threshold representing minimal energy required to excite the His bundle…The HBP control circuit 235 may adjust one or more stimulation parameters using the determined pacing threshold…The threshold test circuit may determine the pacing threshold to be the pulse amplitude…”; figure 6 also shows step 660 which re-delivers HBP pulses when HIS bundle capture is detected).
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Re. claim 11, Hermann teaches a method comprising:
delivering bipolar pacing pulses via a cathode electrode and an anode electrode (abstract – “…His-bundle pacing (HBP) pulses…”; paragraph 0068 – “…the electrostimulation circuit 220 may be configured to deliver bipolar HBP, where the stimulation energy is applied between two electrodes at or near the His bundle…”; paragraph 0105 – “…an extended bipolar HBP vector may consist of a first electrode (e.g., a cathode) selected from the electrodes 112A-112B associated with the first lead 106 and a second electrode (e.g., an anode) selected from the proximal electrodes 131A-131B associated with the second lead 107”);
sensing a first unipolar cardiac electrical signal from the anode electrode following at least one bipolar pacing pulse having a first pacing pulse output delivered via the cathode electrode and the anode electrode (paragraph 0078 – “…the left-ventricular sensing circuit 216 may sense a unipolar LV EGM between an LV electrode…”);
detecting, from the first unipolar cardiac electrical signal, anodal capture by the at least one bipolar pacing pulse having the first pacing pulse output (paragraph 0078 – “…the capture verification circuit 232 may determine the His-bundle capture status using a morphology of an LVS event. The morphology may be extracted from an LV EGM Examples of the morphological features may include a QRS width, a slope of the upstroke or down-stroke branch of the R wave, or an area under the QRS curve, among others”);
selecting a bipolar bundle branch pacing pulse output in response to detecting the anodal capture (paragraph 0105 – “The HBP pulse may be generated according to one or more HBP stimulation strength parameters including, for example, a pulse amplitude, a pulse width, a pulse frequency, a pulse waveform, a duty cycle, or a stimulation duration”);
and delivering bipolar pacing pulses according to the selected bundle branch pacing pulse output (paragraph 0112 – “If at 660 a His-bundle capture is indicated, then the process may continue at 620 to detect AS event and deliver triggered HBP”; paragraph 0105 – “The HBP pulse may be delivered in a unipolar, bipolar, extended polar, or tripolar configuration, among others”).
Re. claim 12, Hermann further teaches delivering the bipolar pacing pulses at a plurality of pacing pulse outputs comprising the first pacing pulse output (figure 6 shows steps 630 and 670 of delivering HBP and LVP pulses, respectively which can be delivered repeatedly and with bipolar configurations; paragraph 0070 – “Bipolar LVP refers to an application of stimulation energy between two electrodes positioned at or near the LV epicardium or endocardium…”; paragraph 0105 – “The HBP pulse may be delivered in a unipolar, bipolar, extended polar, or tripolar configuration, among others”);
determining an anodal capture threshold based on at least the first unipolar cardiac electrical signal sensed from the anode electrode when the bipolar pacing pulses are delivered by the pulse generator at the plurality of pacing pulse outputs (paragraph 0075 – “…the capture verification circuit 232 may decide that a His bundle capture (selective or non-selective) has occurred if the Hp-LV interval falls below a threshold (HV.sub.TH)…”);
and selecting the bundle branch pacing pulse output based on the anodal capture threshold (paragraph 0086 – “In various examples, the control circuit 230 may include a pacing threshold test circuit (not shown) configured to determine a pacing threshold representing minimal energy required to excite the His bundle”).
Re. claim 13, Hermann further teaches wherein selecting the bundle branch pacing pulse output based on detecting the anodal capture comprises selecting the bundle branch pacing pulse output to be at least the anodal capture threshold (paragraph 0086 – ““In various examples, the control circuit 230 may include a pacing threshold test circuit (not shown) configured to determine a pacing threshold representing minimal energy required to excite the His bundle…The HBP control circuit 235 may adjust one or more stimulation parameters using the determined pacing threshold”).
Re. claim 14, Hermann further teaches wherein selecting the bundle branch pacing pulse output based on detecting the anodal capture comprises selecting the bundle branch pacing pulse output to be less than the first pacing pulse output (paragraph 0086 – “The threshold test may include delivering HBP pulses (e.g., via the electrostimulation circuit 220) at or near the His bundle in accordance with a threshold test protocol that defines varying a stimulation parameter at a specified manner, such as ramping up or ramping down the pulse amplitude”).
Re. claim 15, Hermann further teaches selecting the bundle branch pacing pulse output based on detecting the anodal capture by selecting the bundle branch pacing pulse output to be at least the first pacing pulse output (paragraph 0086 – ““In various examples, the control circuit 230 may include a pacing threshold test circuit (not shown) configured to determine a pacing threshold representing minimal energy required to excite the His bundle…The HBP control circuit 235 may adjust one or more stimulation parameters using the determined pacing threshold…The threshold test circuit may determine the pacing threshold to be the pulse amplitude…”; figure 6 also shows step 660 which re-delivers HBP pulses when HIS bundle capture is detected).
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Re. claim 21, Hermann teaches a non-transitory computer readable medium storing instruction (paragraph 0054 – “The IMD 104 may include a hermetically sealed housing 116 that houses a cardiac pacing system 118 and one or more other components including a communication circuit, a battery, a memory circuit, among others”) which, when executed by processing circuitry of a medical device system, cause the device system to:
deliver bipolar pacing pulses via a cathode electrode and an anode electrode (abstract – “…His-bundle pacing (HBP) pulses…”; paragraph 0068 – “…the electrostimulation circuit 220 may be configured to deliver bipolar HBP, where the stimulation energy is applied between two electrodes at or near the His bundle…”; paragraph 0105 – “…an extended bipolar HBP vector may consist of a first electrode (e.g., a cathode) selected from the electrodes 112A-112B associated with the first lead 106 and a second electrode (e.g., an anode) selected from the proximal electrodes 131A-131B associated with the second lead 107”);
sense a unipolar cardiac electrical signal from the anode electrode following at least one bipolar pacing pulse delivered via the cathode electrode and the anode electrode (paragraph 0078 – “…the left-ventricular sensing circuit 216 may sense a unipolar LV EGM between an LV electrode…”);
detect, from the unipolar cardiac electrical signal, anodal capture by the at least one bipolar pacing pulse (paragraph 0078 – “…the capture verification circuit 232 may determine the His-bundle capture status using a morphology of an LVS event. The morphology may be extracted from an LV EGM Examples of the morphological features may include a QRS width, a slope of the upstroke or down-stroke branch of the R wave, or an area under the QRS curve, among others”);
select a bipolar bundle branch pacing pulse output in response to detecting the anodal capture (paragraph 0105 – “The HBP pulse may be generated according to one or more HBP stimulation strength parameters including, for example, a pulse amplitude, a pulse width, a pulse frequency, a pulse waveform, a duty cycle, or a stimulation duration”);
deliver bipolar pacing pulses according to the selected bundle branch pacing pulse output (paragraph 0112 – “If at 660 a His-bundle capture is indicated, then the process may continue at 620 to detect AS event and deliver triggered HBP”; paragraph 0105 – “The HBP pulse may be delivered in a unipolar, bipolar, extended polar, or tripolar configuration, among others”).
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(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hermann (US 20190201698 A1) in view of Bruhns (US 20060047319 A1 – hereinafter Bruhns).
Re. claim 10, Hermann teaches the claimed invention as stated above in claim 1, but does not explicitly teach wherein: the pulse generator is further configured to deliver the bipolar pacing pulses according to a plurality of atrioventricular delays; the processing circuitry is further configured to: determine, for each of the plurality of atrioventricular delays, a feature from at least the first unipolar signal; determine an optimal atrioventricular delay based on at least the first feature; and the pulse generator being further configured to deliver the bipolar pacing pulses according to the selected bundle branch pacing pulse output and the optimal atrioventricular delay.
Bruhns teaches a similar medical device system/method for cardiac pacing (abstract – “Techniques are provided for estimating optimal atrioventricular delay values for use in pacing the ventricles”). Bruhns further teaches pulse generator is further configured to deliver the bipolar pacing pulses according to a plurality of atrioventricular delays (paragraph 0091 – “The microcontroller 460 further includes timing control circuitry (not separately shown) used to control the timing of such stimulation pulses (e.g., pacing rate, atrioventricular delay, atrial interconduction (inter-atrial) delay… the microcontroller 460, determines the polarity of the stimulation pulses (e.g., unipolar, bipolar, combipolar, etc.)…”).
Bruhns further teaches processing circuitry further configured to determine, for each of the plurality of atrioventricular delays, a feature from at least the first unipolar signal (figure 2, step 208 determines features including peaks within the IEGM, or intracardiac electrogram, detailed in figure 4), determine an optimal atrioventricular delay based on at least the first feature (figure 2, step 210 determines atrioventricular delays based on intrinsic atrioventricular conduction delays determined in step 208), and the pulse generator being further configured to deliver the bipolar pacing pulses according to the selected bundle branch pacing pulse output and the optimal atrioventricular delay (figure 2, step 214 delivers adjusted pacing using new atrioventricular values).
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Hermann and Bruhns teach within the field of medical device systems/methods for cardiac pacing as stated above, specifically with bipolar pacing pulses. Therefore, 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 system/method of Hermann to incorporate the processing functions as taught by Bruhns as stated above, since such modification would predictably result in improved cardiac performance (Bruhns paragraph 0041).
Re. claim 20, Hermann teaches the claimed invention as stated above in claim 1, but does not explicitly teach the method further comprising: delivering the bipolar pacing pulses according to a plurality of atrioventricular delays; determining, for each of the plurality of atrioventricular delays, a feature from at least the first unipolar signal; determining an optimal atrioventricular delay based on at least the first feature; and delivering the bipolar pacing pulses according to the selected bundle branch pacing pulse output and the optimal atrioventricular delay.
Bruhns teaches a similar medical device system/method for cardiac pacing (abstract – “Techniques are provided for estimating optimal atrioventricular delay values for use in pacing the ventricles”). Bruhns further teaches pulse generator is further configured to deliver the bipolar pacing pulses according to a plurality of atrioventricular delays (paragraph 0091 – “The microcontroller 460 further includes timing control circuitry (not separately shown) used to control the timing of such stimulation pulses (e.g., pacing rate, atrioventricular delay, atrial interconduction (inter-atrial) delay… the microcontroller 460, determines the polarity of the stimulation pulses (e.g., unipolar, bipolar, combipolar, etc.)…”).
Bruhns further teaches processing circuitry further configured to determine, for each of the plurality of atrioventricular delays, a feature from at least the first unipolar signal (figure 2, step 208 determines features including peaks within the IEGM, or intracardiac electrogram, detailed in figure 4), determine an optimal atrioventricular delay based on at least the first feature (figure 2, step 210 determines atrioventricular delays based on intrinsic atrioventricular conduction delays determined in step 208), and the pulse generator being further configured to deliver the bipolar pacing pulses according to the selected bundle branch pacing pulse output and the optimal atrioventricular delay (figure 2, step 214 delivers adjusted pacing using new atrioventricular values).
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Hermann and Bruhns teach within the field of medical device systems/methods for cardiac pacing as stated above, specifically with bipolar pacing pulses. Therefore, 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 system/method of Hermann to incorporate the processing functions as taught by Bruhns as stated above, since such modification would predictably result in improved cardiac performance (Bruhns paragraph 0041).
Allowable Subject Matter
Claims 6-9 and 16-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record does not reasonably anticipate and/or render obvious to the system/method steps of: determine a first activation time difference from the first unipolar signal and the second unipolar signal sensed following at least one bipolar pacing pulse delivered at the first pacing pulse output; determine a second activation time difference from the first unipolar signal and the second unipolar signal sensed following at least one bipolar pacing pulse delivered at the second pacing pulse output; detect loss of anodal capture from the first unipolar signal sensed following at least one bipolar pacing pulse delivered at the second pacing pulse output; determine that the first activation time difference is less than the second activation time difference; and select the bipolar bundle branch pacing pulse output to be greater than the second pacing pulse output in response to detecting the anodal capture and the first activation time difference being less than the second activation time difference, as claimed in claims 6 and 16. Claims 7 and 17 are further objected due to their dependencies.
Furthermore, the prior art of record does not reasonably anticipate and/or render obvious to the system/method steps of: determine an activation time corresponding to the detected anodal capture from at least the first unipolar cardiac electrical signal; determine that the activation time is greater than the activation time threshold; and select the bundle branch pacing pulse output to be less than the first pacing pulse output in response to detecting the anodal capture associated with the first pacing pulse output and the activation time being greater than the activation time threshold, as claimed in claims 8 and 18. Claims 9 and 19 are further rejected due to their dependencies.
Conclusion
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/ANH-KHOA N DINH/Examiner, Art Unit 3796