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
This Office Action is responsive to the amendment filed on 08 Jul 2026. As directed by the amendment: claim 1 has been amended, no claims have been canceled, and no claims have been added. Thus, claims 1-25 are presently pending in this application.
The amendments to the drawings and specification are acknowledged.
Response to Arguments
Claim Rejections-35 U.S.C. § 102
Applicant's arguments filed 08 Jul 2026 have been fully considered but they are not persuasive.
Applicant argues that the previously cited Gunderson ‘733 reference “does not disclose signal processing circuitry configured to ‘process the cardiac electrical signal according to the at least one operating parameter setting [selected based on the determined medical lead type] for determining a need for an electrical stimulation therapy’ (emphasis added), as originally recited in claim 1” (Remarks, page 14) because “Gunderson does not disclose or suggest that any operating parameter for processing a cardiac electrical signal for determining a need for electrical stimulation therapy is selected based on a detected lead type” (Remarks, page 15). Examiner respectfully disagrees.
Examiner agrees with Applicant’s argument that “A lead impedance measured to detect a lead-related condition is clearly not a ‘cardiac electrical signal’ processed ‘for determining a need for an electrical stimulation therapy’” (Remarks, page 15). Although during the interview on 20 June 2026 it was agreed that the lead impedance in Gunderson ‘733 is not a cardiac electrical signal, upon further consideration, Gunderson ‘733 does disclose a cardiac electrical signal, which is signals from the electrodes (paragraph [0039], “Electrodes 324 and 326 correspond to electrodes 24 and 26, and are used for sensing and pacing in the ventricle. Electrodes 317 and 321 correspond to electrodes 19 and 21 and are used for pacing and sensing in the atrium”; paragraph [0042], “Signals from the electrodes selected for coupling to bandpass amplifier 210 are provided to multiplexer 220, and thereafter converted to multi-bit digital signals by A/D converter 222, for storage in random access memory 226 under control of direct memory access circuit 228. Microprocessor 224 may employ digital signal analysis techniques to characterize the digitized signals stored in random access memory 226 to recognize and classify the patient's heart rhythm employing any of the numerous signal processing methodologies known to the art”).
These cardiac electrical signals are used in oversensing detection (paragraphs [0056]-[0059] disclose using measured RR-intervals to determine whether oversensing is likely occurring), which is a method of processing the cardiac electrical signal.
Oversensing detection is a step in determining a need for electrical stimulation therapy (paragraph [0053], “If oversensing is likely occurring, the delivery of therapy, such as shock therapy, for example, is withheld, Block 346. On the other hand, if oversensing is not likely occurring, normal delivery of the therapy takes place, Block 344”).
The at least one operating parameter setting in Gunderson ‘733 is whether oversensing detection is performed. Whether oversensing detection is performed is dependent on whether a lead-related condition is detected, which is dependent on the medical lead type (Fig. 3, paragraph [0053], “once the presence of a lead-related condition is detected, determining whether oversensing is likely taking place, Block 342”; paragraph [0055], "If it is determined that more than one of the criteria have been met, such as both of the oversensing criteria or at least one of the oversensing criteria and the impedance criteria, the likelihood of a lead-related condition is satisfied, and a determination as to whether oversensing is likely occurring is initiated, Block 717"). In other words, Gunderson ‘733 selects whether to perform oversensing detection based on the lead-related condition, which is dependent on the medical lead type.
Therefore, Gunderson ‘733 discloses “process[ing] the cardiac electrical signal according to the at least one operating parameter setting to determine a need for an electrical stimulation therapy”, as recited in claim 1.
Therefore, the rejection of claim 1 under 35 U.S.C. 102 is maintained. The rejections of claims 13 and 25 are also maintained for similar reasons.
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, 3-6, 10, 12-13, 15-18, 22, and 24-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gunderson (US 20060116733 A1, previously cited), hereinafter Gunderson '733.
Regarding claim 1, Gunderson '733 discloses a medical device (Fig. 1, paragraph [0033], pacemaker/cardioverter/defibrillator 10), comprising:
a connector bore (Fig. 1, paragraph [0036], connector block 12) configured to receive a proximal portion of a medical lead (Fig. 1, paragraph [0036], connector assemblies 13 and 14), the connector bore comprising at least a first electrical contact and a second electrical contact (paragraphs [0033]-[0034], bifurcated connectors 13 and 14 each carry three electrical connectors);
an impedance measurement circuit (Fig. 2, paragraph [0072], impedance measurement circuit 204) configured to obtain an impedance measurement (paragraph [0069]) between a first electrical terminal corresponding to the first electrical contact of the connector bore and a second electrode terminal corresponding to the second electrical contact of the connector bore (paragraph [0069], "For the configuration shown in FIG. 1, a preferred set of lead impedance measurements includes a low voltage pacing impedance measured across tip electrode 26 and ring electrode 24 and high voltage impedances measured across: 1) ring electrode 24 and can 11, 2) ring electrode 24 and coil electrode 20, 3) tip electrode 26 and coil electrode 20, and 4) tip electrode 26 and can 11"); and
a control circuit (Fig. 2, paragraph [0072], microprocessor 224) configured to:
determine a medical lead type of the medical lead received by the connector bore based on the impedance measurement (Fig. 3, paragraph [0093], "supplementary analyses preferably include tests that will exclude types of leads that would not be subject to the particular type of lead-related condition being investigated"), wherein the medical lead type is determined (paragraphs [0099]-[0101]) to be one of an integrated bipolar lead (paragraph [0069], tip electrode 26 and coil electrode 20)or a true bipolar lead (paragraph [0069], tip electrode 26 and ring electrode 24); and
select at least one operating parameter setting based on the determined medical lead type (Fig. 3, paragraph [0053], “once the presence of a lead-related condition is detected, determining whether oversensing is likely taking place, Block 342”; paragraph [0055], "If it is determined that more than one of the criteria have been met, such as both of the oversensing criteria or at least one of the oversensing criteria and the impedance criteria, the likelihood of a lead-related condition is satisfied, and a determination as to whether oversensing is likely occurring is initiated, Block 717"; paragraph [0084], "Diagnostic criteria set for detecting a lead-related condition based on comparisons between a periodic impedance measurement and short-term and long-term impedance parameters may be tailored to a particular lead type. For example, the difference between a periodic lead measurement and an impedance parameter trend and the number of periodic measurements deviating significantly from an impedance parameter trend may be uniquely defined depending on the type of lead being monitored"); and
signal processing circuitry (Fig. 2, paragraph [0042], microprocessor 224) configured to:
receive a cardiac electrical signal (paragraph [0042], "Signals from the electrodes selected for coupling to bandpass amplifier 210 are provided to multiplexer 220, and thereafter converted to multi-bit digital signals by A/D converter 222, for storage in random access memory 226 under control of direct memory access circuit 228. Microprocessor 224 may employ digital signal analysis techniques to characterize the digitized signals stored in random access memory 226 to recognize and classify the patient's heart rhythm employing any of the numerous signal processing methodologies known to the art"); and
process the cardiac electrical signal according to the at least one operating parameter setting to determine a need for an electrical stimulation therapy (paragraphs [0056]-[0059] disclose using measured RR-intervals to determine whether oversensing is likely occurring; paragraph [0053], “If oversensing is likely occurring, the delivery of therapy, such as shock therapy, for example, is withheld, Block 346. On the other hand, if oversensing is not likely occurring, normal delivery of the therapy takes place, Block 344”); and
a therapy delivery circuit (Fig. 2, paragraph [0052], cardioversion/defibrillation control circuitry 230) configured to deliver the electrical stimulation therapy in response to the signal processing circuitry determining the need for the electrical stimulation therapy (paragraph [0053], "if oversensing is not likely occurring, normal delivery of the therapy takes place"; paragraphs [0113], [0121], "therapy is delivered as determined necessary").
Regarding claim 3, Gunderson '733 discloses the medical device of claim 1, as explained above. Gunderson '733 further discloses that:
the signal processing circuitry is configured to detect cardiac event oversensing (paragraph [0053], "determining whether oversensing is likely taking place"); and
the control circuit is further configured to select the at least one operating parameter setting by:
enabling detecting the cardiac event oversensing by the signal processing circuitry in response to determining the medical lead type as being the integrated bipolar lead (paragraph [0055], "If it is determined that more than one of the criteria have been met, such as both of the oversensing criteria or at least one of the oversensing criteria and the impedance criteria, the likelihood of a lead-related condition is satisfied, and a determination as to whether oversensing is likely occurring is initiated, Block 717").
Regarding claim 4, Gunderson '733 discloses the medical device of claim 3, as explained above. Gunderson '733 further discloses that the signal processing circuitry is further configured to detect the cardiac event oversensing by detecting P-wave oversensing (paragraph [0048], "The value of the count present in the escape interval counters when reset by sensed R-waves and P-waves may be used to measure the durations of R-R intervals; P-P intervals, PR intervals and R-P intervals, which measurements are stored in memory 226 and are used in conjunction with the present invention to determine oversensing and in conjunction with tachyarrhythmia detection functions.")
Regarding claim 5, Gunderson '733 discloses the medical device of claim 1, as explained above. Gunderson '733 further discloses that:
the signal processing circuitry is configured to detect cardiac event oversensing by:
sensing a plurality of cardiac event signals from the cardiac electrical signal (Fig. 7, paragraph [0067], block 760);
determining at least one signal feature from each of the plurality of cardiac event signals (paragraph [0065], non-sustained VT events); and
determining an alternating pattern of the determined signal features based on at least one threshold applied to the determined signal features (paragraph [0068]); and
the control circuit is further configured to select the at least one operating parameter setting by one of:
selecting a first value of the threshold in response to determining the medical lead type being the integrated bipolar lead; or selecting a second value of the threshold different than the first value in response to determining the medical lead type being the true bipolar lead (paragraph [0071], "An acceptable range may be a predefined range of impedances known to be normal for a particular lead type").
Regarding claim 6, Gunderson '733 discloses the medical device of claim 1, as explained above. Gunderson '733 further discloses that:
the signal processing circuitry is configured to detect cardiac event oversensing by:
sensing a plurality of cardiac event signals from the cardiac electrical signal (Fig. 7, paragraph [0067], block 760);
determining at least one signal feature from each of the plurality of cardiac event signals (paragraph [0067], non-sustained VT events); and
determining an alternating pattern of the determined signal features based on at least one threshold applied to the determined signal features (paragraph [0068]); and
the control circuit is further configured to select the at least one operating parameter setting by one of:
selecting a first signal feature to be determined by the signal processing circuitry from each of the plurality of cardiac event signals in response to determining the medical lead type being the integrated bipolar lead; or selecting a second signal feature to be determined by the signal processing circuitry from each of the plurality of cardiac event signals in response to determining the medical lead type being the true bipolar lead, the second signal feature being different than the first signal feature (paragraph [0083], "Diagnostic criteria set for detecting a lead-related condition based on comparisons between a periodic impedance measurement and short-term and long-term impedance parameters may be tailored to a particular lead type. For example, the difference between a periodic lead measurement and an impedance parameter trend and the number of periodic measurements deviating significantly from an impedance parameter trend may be uniquely defined depending on the type of lead being monitored.").
Regarding claim 10, Gunderson '733 discloses the medical device of claim 1, as explained above. Gunderson '733 further discloses that:
the impedance circuit is further configured to determine a bipolar lead impedance measurement (paragraph [0069], "For the configuration shown in FIG. 1, a preferred set of lead impedance measurements includes a low voltage pacing impedance measured across tip electrode 26 and ring electrode 24 and high voltage impedances measured across: 1) ring electrode 24 and can 11, 2) ring electrode 24 and coil electrode 20, 3) tip electrode 26 and coil electrode 20, and 4) tip electrode 26 and can 11"); and
the control circuit is further configured to:
select the at least one operating parameter setting by one of:
selecting a first range of a normal bipolar lead impedance range in response to determining the medical lead type being the integrated bipolar lead; or
selecting a second range of the normal bipolar lead impedance range in response to determining the medical lead type being the true bipolar lead, where the second range is different than the first range (paragraph [0071], "As a safety check in case of a sudden lead failure, a most recent lead impedance measurement may be compared to an acceptable range at decision Block 380. An acceptable range may be a predefined range of impedances known to be normal for a particular lead type"; paragraph [0100]);
determine that the bipolar lead impedance measurement is outside the selected one of the first range or the second range of the normal bipolar lead impedance range (paragraph [0071], "If a single measurement is out of the acceptable range, a lead-related condition is diagnosed at Block 385"); and
generate an output in response to determining that the bipolar lead impedance measurement is outside the normal bipolar lead impedance range (paragraph [0070], "At optional Block 390, patient notification signal may be generated so that the patient is aware of a potential problem and seeks medical attention"); and
the memory being configured to store the bipolar lead impedance measurement with the output generated by the control circuit (paragraph [0070], "The diagnosed condition and supporting data may be stored in memory 226 at Block 387 so that a clinician may upload this information to an external device for review").
Regarding claim 12, Gunderson '733 discloses the medical device of claim 1, as explained above. Gunderson '733 further discloses that the control circuit is further configured to determine the medical lead type by:
comparing the impedance measurement to a threshold impedance (paragraph [0100], range is analogous to threshold); and
responsive to the impedance measurement being less than the threshold impedance, determining the medical lead type as being the integrated bipolar lead (paragraph [0100], "The ring-coil impedances measured in an integrated bipolar lead will be considerably lower than the ring-coil impedances measured in a true bipolar lead. ... If this maximum remains in a lower range, typical of an integrated bipolar lead, then the lead is known to be an integrated bipolar lead") having a first elongated coil electrode of the integrated bipolar lead electrically coupled to the first electrode terminal and electrically coupled to the second electrode terminal (paragraph [0033], elongated coil electrode 20; paragraph [0069], tip electrode 26 and coil electrode 20); or
responsive to the impedance measurement being greater than the threshold impedance, determining the medical lead type as being the true bipolar lead (paragraph [0100], "if the maximum long-term ring-coil impedance remains in a higher range, associated with a true bipolar lead, then the lead is known to be a true bipolar lead") having a second elongated coil electrode of the true bipolar lead electrically coupled to the first electrode terminal and a ring electrode of the true bipolar lead electrically coupled to the second electrode terminal (paragraph [0069], ring electrode 24 and coil electrode 20).
Regarding claim 13, Gunderson '733 discloses a non-transitory, computer readable medium storing a set of instructions (paragraph [0126]) that, when executed by a control circuit (Fig. 2, paragraph [0072], microprocessor 224) of a medical device (Fig. 1, paragraph [0033], pacemaker/cardioverter/defibrillator 10), cause the medical device to:
obtain an impedance measurement between a first electrode terminal corresponding to a first electrical contact of a connector bore (Fig. 1, paragraph [0036], connector block 12) of the medical device and a second electrode terminal corresponding to a second electrical contact of the connector bore (paragraph [0069], "For the configuration shown in FIG. 1, a preferred set of lead impedance measurements includes a low voltage pacing impedance measured across tip electrode 26 and ring electrode 24 and high voltage impedances measured across: 1) ring electrode 24 and can 11, 2) ring electrode 24 and coil electrode 20, 3) tip electrode 26 and coil electrode 20, and 4) tip electrode 26 and can 11"), the connector bore being configured to receive a proximal portion of a medical lead (Fig. 1, paragraph [0036], connector assemblies 13 and 14);
based on the impedance measurement, determine a medical lead type of the medical lead received by the connector bore (Fig. 3, paragraph [0093], "supplementary analyses preferably include tests that will exclude types of leads that would not be subject to the particular type of lead-related condition being investigated"), wherein the medical lead type is determined to be one of an integrated bipolar lead or a true bipolar lead (paragraphs [0099]-[0101]);
select at least one operating parameter setting based on the determined medical lead type (Fig. 3, paragraph [0053], “once the presence of a lead-related condition is detected, determining whether oversensing is likely taking place, Block 342”; paragraph [0055], "If it is determined that more than one of the criteria have been met, such as both of the oversensing criteria or at least one of the oversensing criteria and the impedance criteria, the likelihood of a lead-related condition is satisfied, and a determination as to whether oversensing is likely occurring is initiated, Block 717"; paragraph [0084], "Diagnostic criteria set for detecting a lead-related condition based on comparisons between a periodic impedance measurement and short-term and long-term impedance parameters may be tailored to a particular lead type. For example, the difference between a periodic lead measurement and an impedance parameter trend and the number of periodic measurements deviating significantly from an impedance parameter trend may be uniquely defined depending on the type of lead being monitored"); and
process a cardiac electrical signal according to the at least one operating parameter setting for determining a need for an electrical stimulation therapy (paragraphs [0056]-[0059] disclose using measured RR-intervals to determine whether oversensing is likely occurring; paragraph [0053], “If oversensing is likely occurring, the delivery of therapy, such as shock therapy, for example, is withheld, Block 346. On the other hand, if oversensing is not likely occurring, normal delivery of the therapy takes place, Block 344”); and
deliver the electrical stimulation therapy in response to determining the need for the electrical stimulation therapy (paragraph [0053], "if oversensing is not likely occurring, normal delivery of the therapy takes place"; paragraphs [0113], [0121], "therapy is delivered as determined necessary").
Regarding claim 15, Gunderson '733 discloses the non-transitory computer readable medium of claim 13, as explained above. Gunderson '733 further discloses instructions that cause the medical device to:
process the cardiac electrical signal to detect cardiac event oversensing (paragraph [0053], "determining whether oversensing is likely taking place"); and
select the at least one operating parameter setting by:
enabling detecting the cardiac event oversensing by the signal processing circuitry in response to determining the medical lead type as being the integrated bipolar lead or (paragraph [0055], "If it is determined that more than one of the criteria have been met, such as both of the oversensing criteria or at least one of the oversensing criteria and the impedance criteria, the likelihood of a lead-related condition is satisfied, and a determination as to whether oversensing is likely occurring is initiated, Block 717").
Regarding claim 16, Gunderson '733 discloses the non-transitory computer readable medium of claim 15, as explained above. Gunderson '733 further discloses instructions that cause the medical device to detect the cardiac event oversensing by detecting P-wave oversensing (paragraph [0048], "The value of the count present in the escape interval counters when reset by sensed R-waves and P-waves may be used to measure the durations of R-R intervals; P-P intervals, PR intervals and R-P intervals, which measurements are stored in memory 226 and are used in conjunction with the present invention to determine oversensing and in conjunction with tachyarrhythmia detection functions.").
Regarding claim 17, Gunderson '733 discloses the non-transitory computer readable medium of claim 13, as explained above. Gunderson '733 further discloses instructions that cause the medical device to:
process the cardiac electrical signal to detect cardiac event oversensing by:
sensing a plurality of cardiac event signals from the cardiac electrical signal (Fig. 7, paragraph [0067], block 760);
determining at least one signal feature from each of the plurality of cardiac event signals (paragraph [0065], non-sustained VT events); and
determining an alternating pattern of the determined signal features based on at least one threshold applied to the determined signal features (paragraph [0068]); and
select that at least one operating parameter setting by one of:
selecting a first value of the threshold in response to determining the medical lead type being the integrated bipolar lead; or selecting a second value of the threshold different than the first value in response to determining the medical lead type being the true bipolar lead (paragraph [0071], "An acceptable range may be a predefined range of impedances known to be normal for a particular lead type").
Regarding claim 18, Gunderson '733 discloses the non-transitory computer readable medium of claim 13, as explained above. Gunderson '733 further discloses instructions that cause the medical device to:
process the cardiac electrical signal to detect cardiac event oversensing by:
sensing a plurality of cardiac event signals from the cardiac electrical signal (Fig. 7, paragraph [0067], block 760);
determining at least one signal feature from each of the plurality of cardiac event signals (paragraph [0067], non-sustained VT events); and
determining an alternating pattern of the determined signal features based on at least one threshold applied to the determined signal features (paragraph [0068]); and
select the at least one operating parameter setting by one of:
selecting a first signal feature to be determined by the signal processing circuitry from each of the plurality of cardiac event signals in response to determining the medical lead type being the integrated bipolar lead; or selecting a second signal feature to be determined by the signal processing circuitry from each of the plurality of cardiac event signals in response to determining the medical lead type being the true bipolar lead, the second signal feature being different than the first signal feature (paragraph [0083], "Diagnostic criteria set for detecting a lead-related condition based on comparisons between a periodic impedance measurement and short-term and long-term impedance parameters may be tailored to a particular lead type. For example, the difference between a periodic lead measurement and an impedance parameter trend and the number of periodic measurements deviating significantly from an impedance parameter trend may be uniquely defined depending on the type of lead being monitored.").
Regarding claim 22, Gunderson '733 discloses the non-transitory computer readable medium of claim 13, as explained above. Gunderson '733 further discloses instructions that cause the medical device to:
determine a bipolar lead impedance measurement (paragraph [0069], "For the configuration shown in FIG. 1, a preferred set of lead impedance measurements includes a low voltage pacing impedance measured across tip electrode 26 and ring electrode 24 and high voltage impedances measured across: 1) ring electrode 24 and can 11, 2) ring electrode 24 and coil electrode 20, 3) tip electrode 26 and coil electrode 20, and 4) tip electrode 26 and can 11"); and
select the at least one operating parameter setting by one of:
selecting a first range of a normal bipolar lead impedance range in response to determining the medical lead type being the integrated bipolar lead; or
selecting a second range of the normal bipolar lead impedance range in response to determining the medical lead type being the true bipolar lead, where the second range is different than the first range (paragraph [0071], "As a safety check in case of a sudden lead failure, a most recent lead impedance measurement may be compared to an acceptable range at decision Block 380. An acceptable range may be a predefined range of impedances known to be normal for a particular lead type"; paragraph [0100]);
determine that the bipolar lead impedance measurement is outside the selected one of the first range or the second range of the normal bipolar lead impedance range (paragraph [0071], "If a single measurement is out of the acceptable range, a lead-related condition is diagnosed at Block 385"); and
generate an output in response to determining that the bipolar lead impedance measurement is outside the normal bipolar lead impedance range (paragraph [0070], "At optional Block 390, patient notification signal may be generated so that the patient is aware of a potential problem and seeks medical attention"); and
store the bipolar lead impedance measurement with the output (paragraph [0070], "The diagnosed condition and supporting data may be stored in memory 226 at Block 387 so that a clinician may upload this information to an external device for review").
Regarding claim 24, Gunderson '733 discloses the non-transitory computer readable medium of claim 13, as explained above. Gunderson '73 further discloses instructions that cause the medical device to:
compare the impedance measurement to a threshold impedance (paragraph [0100], range is analogous to threshold); and
responsive to the impedance measurement being less than the threshold impedance, determine the medical lead type as being the integrated bipolar lead (paragraph [0100], "The ring-coil impedances measured in an integrated bipolar lead will be considerably lower than the ring-coil impedances measured in a true bipolar lead. ... If this maximum remains in a lower range, typical of an integrated bipolar lead, then the lead is known to be an integrated bipolar lead") having a first elongated coil electrode of the integrated bipolar lead electrically coupled to the first electrode terminal and electrically coupled to the second electrode terminal (paragraph [0033], elongated coil electrode 20; paragraph [0069], tip electrode 26 and coil electrode 20); or
responsive to the impedance measurement being greater than the threshold impedance, determine the medical lead type as being the true bipolar lead (paragraph [0100], "if the maximum long-term ring-coil impedance remains in a higher range, associated with a true bipolar lead, then the lead is known to be a true bipolar lead") having a second elongated coil electrode of the true bipolar lead electrically coupled to the first electrode terminal and a ring electrode of the true bipolar lead electrically coupled to the second electrode terminal (paragraph [0069], ring electrode 24 and coil electrode 20).
Regarding claim 25, Gunderson '733 discloses a method comprising:
obtaining an impedance measurement between a first electrode terminal corresponding to a first electrical contact of a connector bore (Fig. 1, paragraph [0036], connector block 12) of a medical device (Fig. 1, paragraph [0033], pacemaker/cardioverter/defibrillator 10) and a second electrode terminal corresponding to a second electrical contact of the connector bore (paragraph [0069], "For the configuration shown in FIG. 1, a preferred set of lead impedance measurements includes a low voltage pacing impedance measured across tip electrode 26 and ring electrode 24 and high voltage impedances measured across: 1) ring electrode 24 and can 11, 2) ring electrode 24 and coil electrode 20, 3) tip electrode 26 and coil electrode 20, and 4) tip electrode 26 and can 11"), the connector bore being configured to receive a proximal portion of a medical lead (Fig. 1, paragraph [0036], connector assemblies 13 and 14);
based on the impedance measurement, determine a medical lead type of the medical lead received by the connector bore (Fig. 3, paragraph [0093], "supplementary analyses preferably include tests that will exclude types of leads that would not be subject to the particular type of lead-related condition being investigated"), wherein the medical lead type is determined to be one of an integrated bipolar lead or a true bipolar lead (paragraphs [0099]-[0101]);
select at least one operating parameter setting based on the determined medical lead type (paragraph [0084], "the difference between a periodic lead measurement and an impedance parameter trend and the number of periodic measurements deviating significantly from an impedance parameter trend may be uniquely defined depending on the type of lead being monitored"); and
receiving a cardiac electrical signal sensed via the first electrode terminal and the second electrode terminal (paragraph [0042]);
processing the cardiac electrical signal according to the at least one operating parameter setting for determining a need for an electrical stimulation therapy (paragraphs [0056]-[0059] disclose using measured RR-intervals to determine whether oversensing is likely occurring; paragraph [0053], “If oversensing is likely occurring, the delivery of therapy, such as shock therapy, for example, is withheld, Block 346. On the other hand, if oversensing is not likely occurring, normal delivery of the therapy takes place, Block 344”); and
delivering the electrical stimulation therapy in response to determining the need for the electrical stimulation therapy (paragraph [0053], "if oversensing is not likely occurring, normal delivery of the therapy takes place"; paragraphs [0113], [0121], "therapy is delivered as determined necessary").
Claim Rejections - 35 USC § 103
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson (US 20060116733 A1, previously cited), hereinafter Gunderson '733, in view of Andersen et al. (US 20220117560 A1, previously cited), hereinafter Andersen.
Regarding claim 2, Gunderson '733 discloses the medical device of claim 1, as explained above. Gunderson '733 does not explicitly disclose that the signal processing circuitry includes a notch filter; and the control circuit is further configured to select the at least one operating parameter setting by enabling the notch filter in response to determining the medical lead type as being the integrated bipolar lead.
However, Andersen teaches methods and systems for filtering noise of an implantable medical device (paragraph [0001]) wherein:
the signal processing circuitry includes a notch filter (paragraph [0038], notch filter; paragraph [0046], band-stop filter 235); and
the control circuit is further configured to select the at least one operating parameter setting by enabling the notch filter in response to determining the medical lead type as being the integrated bipolar lead (paragraph [0038]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson '733 with the teachings of Andersen so that the signal processing circuitry includes a notch filter; and the control circuit is further configured to select the at least one operating parameter setting by enabling the notch filter in response to determining the medical lead type as being the integrated bipolar lead, because doing so blocks frequency components associated with environmental noise (Andersen, paragraph [0038]).
Regarding claim 14, Gunderson '733 discloses the non-transitory computer readable medium of claim 13, as explained above. Gunderson '733 does not explicitly disclose instructions that cause the medical device to select the at least one operating parameter setting by enabling a notch filter in response to determining the medical lead type as being the integrated bipolar lead.
However, Andersen teaches methods and systems for filtering noise of an implantable medical device (paragraph [0001]) wherein: the signal processing circuitry includes a notch filter (paragraph [0038], notch filter; paragraph [0046], band-stop filter 235); and the control circuit is further configured to select the at least one operating parameter setting by enabling the notch filter in response to determining the medical lead type as being the integrated bipolar lead (paragraph [0038]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson '733 with the teachings of to include instructions that cause the medical device to select the at least one operating parameter setting by enabling a notch filter in response to determining the medical lead type as being the integrated bipolar lead, because doing so blocks frequency components associated with environmental noise (Andersen, paragraph [0038]).
Claims 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson (US 20060116733 A1, previously cited), hereinafter Gunderson '733, in view of Gunderson (US 20040015197 A1, previously cited), hereinafter Gunderson '197.
Regarding claim 7, Gunderson '733 discloses the medical device of claim 1, as explained above. Gunderson '733 does not explicitly disclose that the signal processing circuitry is further configured to detect non-cardiac noise signals in the cardiac electrical signal; and the control circuit is further configured to select the at least one operating parameter setting by enabling detecting non-cardiac noise signals in the cardiac electrical signal by the signal processing circuitry in response to determining the medical lead type being the integrated bipolar lead.
However, Gunderson '197 teaches a method and apparatus for automatically identifying various types of cardiac and non-cardiac oversensing (Abstract) wherein:
the signal processing circuitry is further configured to detect non-cardiac noise signals in the cardiac electrical signal (paragraphs [0009]-[0010], [0052], [0096]); and
the control circuit is further configured to select the at least one operating parameter setting by enabling detecting non-cardiac noise signals in the cardiac electrical signal by the signal processing circuitry in response to determining the medical lead type being the integrated bipolar lead (paragraph [0107], "Possible corrective actions for oversensing caused by a non-cardiac origin, e.g., myopotentials or EMI, include increasing a sensitivity value of a sensing electrode to decrease the sensitivity, reconfiguring the electrode configuration from tip-to-ring (true bipolar) to tip-to-coil (integrated bipolar), increasing a decay constant of the electrode, or increasing the maximum auto-adjusting sensitivity threshold").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson '733 with the teachings of Gunderson '197 so that the signal processing circuitry is further configured to detect non-cardiac noise signals in the cardiac electrical signal; and the control circuit is further configured to select the at least one operating parameter setting by enabling detecting non-cardiac noise signals in the cardiac electrical signal by the signal processing circuitry in response to determining the medical lead type being the integrated bipolar lead, because doing so reduces the likelihood of oversensing (Gunderson '197, paragraph [0107]).
Regarding claim 19, Gunderson '733 discloses the non-transitory computer readable medium of claim 13, as explained above. Gunderson '733 does not explicitly disclose instructions that cause the medical device to: process the cardiac electrical signal to detect non-cardiac noise signals in the cardiac electrical signal; and select the at least one operating parameter setting by enabling detecting non-cardiac noise signals in the cardiac electrical signal in response to determining the medical lead type being the integrated bipolar lead.
However, Gunderson '197 teaches a method and apparatus for automatically identifying various types of cardiac and non-cardiac oversensing (Abstract) wherein:
the signal processing circuitry is further configured to detect non-cardiac noise signals in the cardiac electrical signal (paragraphs [0009]-[0010], [0052], [0096]); and
the control circuit is further configured to select the at least one operating parameter setting by enabling detecting non-cardiac noise signals in the cardiac electrical signal by the signal processing circuitry in response to determining the medical lead type being the integrated bipolar lead (paragraph [0107], "Possible corrective actions for oversensing caused by a non-cardiac origin, e.g., myopotentials or EMI, include increasing a sensitivity value of a sensing electrode to decrease the sensitivity, reconfiguring the electrode configuration from tip-to-ring (true bipolar) to tip-to-coil (integrated bipolar), increasing a decay constant of the electrode, or increasing the maximum auto-adjusting sensitivity threshold").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson '733 with the teachings of Gunderson '197 to include instructions that cause the medical device to: process the cardiac electrical signal to detect non-cardiac noise signals in the cardiac electrical signal; and select the at least one operating parameter setting by enabling detecting non-cardiac noise signals in the cardiac electrical signal in response to determining the medical lead type being the integrated bipolar lead, because doing so reduces the likelihood of oversensing (Gunderson '197, paragraph [0107]).
Claims 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson (US 20060116733 A1, previously cited), hereinafter Gunderson '733, in view of Patel et al. (US 20130079651 A1, previously cited), hereinafter Patel.
Regarding claim 8, Gunderson '733 discloses the medical device of claim 1, as explained above. Gunderson '733 does not explicitly disclose that the signal processing circuitry is further configured to: determine a morphology matching score between a previously established morphology template corresponding to a cardiac event signal and an unknown event signal in the cardiac electrical signal; and compare the morphology matching score to a morphology match threshold for determining when the unknown event signal is the cardiac event signal; and the control circuit is further configured to select the at least one operating parameter setting by one of: selecting a first value of the morphology match threshold in response to determining the medical lead type being the integrated bipolar lead; or selecting a second value of the morphology match threshold different than the first value in response to determining the medical lead type being the true bipolar lead.
However, Patel teaches an algorithm for classifying cardiac episodes detected by an implantable medical device (paragraph [0001]), wherein:
the signal processing circuitry (Fig. 2, paragraph [0054], processor 70) is configured to:
determine a morphology matching score between a previously established morphology template corresponding to a cardiac event signal and an unknown event signal in the cardiac electrical signal (paragraph [0035], "The sinus template may be used by a post-processing algorithm to determine whether the morphology of the beats within an episode corresponds to the sinus template"); and
compare the morphology matching score to a morphology match threshold for determining when the unknown event signal is the cardiac event signal (paragraph [0095], "A determination is then made as to whether the correlation between the morphologies of the two intervals is greater than a predetermined correlation threshold"); and
the control circuit (Fig. 2, paragraph [0054], processor 70) is configured to select the at least one operating parameter setting by:
selecting a first value of the morphology match threshold in response to determining the medical lead type being the integrated bipolar lead; or selecting a second value of the morphology match threshold different than the first value in response to determining the medical lead type being the true bipolar lead (paragraph [0031], "A post-processing classification algorithm using both a NF EGM channel and A FF EGM channel may be different in certain respects for each channel. For example, different thresholds may be used on the NF and FF channel").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson '733 with the teachings of Patel so that the signal processing circuitry is further configured to: determine a morphology matching score between a previously established morphology template corresponding to a cardiac event signal and an unknown event signal in the cardiac electrical signal; and compare the morphology matching score to a morphology match threshold for determining when the unknown event signal is the cardiac event signal; and the control circuit is further configured to select the at least one operating parameter setting by one of: selecting a first value of the morphology match threshold in response to determining the medical lead type being the integrated bipolar lead; or selecting a second value of the morphology match threshold different than the first value in response to determining the medical lead type being the true bipolar lead, because doing so can reduce the number of EGM episodes that cannot be classified confidently (Patel, paragraph [0030]).
Regarding claim 20, Gunderson '733 discloses the non-transitory computer readable medium of claim 13, as explained above. Gunderson '733 does not explicitly disclose instructions that cause the medical device to: process the cardiac electrical signal to determine a morphology matching score between a previously established morphology template corresponding to a cardiac event signal and an unknown event signal in the cardiac electrical signal; compare the morphology matching score to a morphology match threshold for determining when the unknown event signal is the cardiac event signal; and select the at least one operating parameter setting by one of: selecting a first value of the morphology match threshold in response to determining the medical lead type being the integrated bipolar lead; or selecting a second value of the morphology match threshold different than the first value in response to determining the medical lead type being the true bipolar lead.
However, Patel teaches an algorithm for classifying cardiac episodes detected by an implantable medical device (paragraph [0001]), comprising instructions to:
process the cardiac electrical signal to determine a morphology matching score between a previously established morphology template corresponding to a cardiac event signal and an unknown event signal in the cardiac electrical signal (paragraph [0035], "The sinus template may be used by a post-processing algorithm to determine whether the morphology of the beats within an episode corresponds to the sinus template"); and
compare the morphology matching score to a morphology match threshold for determining when the unknown event signal is the cardiac event signal (paragraph [0095], "A determination is then made as to whether the correlation between the morphologies of the two intervals is greater than a predetermined correlation threshold"); and
select the at least one operating parameter setting by one of:
selecting a first value of the morphology match threshold in response to determining the medical lead type being the integrated bipolar lead; or selecting a second value of the morphology match threshold different than the first value in response to determining the medical lead type being the true bipolar lead (paragraph [0031], "A post-processing classification algorithm using both a NF EGM channel and A FF EGM channel may be different in certain respects for each channel. For example, different thresholds may be used on the NF and FF channel").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson '733 with the teachings of Patel to include instructions that cause the medical device to: process the cardiac electrical signal to determine a morphology matching score between a previously established morphology template corresponding to a cardiac event signal and an unknown event signal in the cardiac electrical signal; compare the morphology matching score to a morphology match threshold for determining when the unknown event signal is the cardiac event signal; and select the at least one operating parameter setting by one of: selecting a first value of the morphology match threshold in response to determining the medical lead type being the integrated bipolar lead; or selecting a second value of the morphology match threshold different than the first value in response to determining the medical lead type being the true bipolar lead, because doing so can reduce the number of EGM episodes that cannot be classified confidently (Patel, paragraph [0030]).
Claims 9 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson (US 20060116733 A1, previously cited), hereinafter Gunderson '733, in view of Chen et al. (US 20230190169 A1, previously cited), hereinafter Chen.
Regarding claim 9, Gunderson '733 discloses the medical device of claim 1, as explained above. Gunderson '733 does not explicitly disclose that the signal processing circuitry is further configured to: determining a morphology matching score between a previously established morphology template corresponding to a cardiac event signal and an unknown event signal in the cardiac electrical signal; and compare the morphology matching score to a morphology match threshold for determining when the unknown event signal is the cardiac event signal; and the control circuit is further configured to select the at least one operating parameter setting by: determining that the medical lead type is different than a previously determined medical lead type; and re-establishing the morphology template from the cardiac electrical signal in response to determining that the medical lead type is different than the previously determined medical lead type.
However, Chen teaches an apparatus and method for detecting a pace pulse signal (Abstract) wherein:
the signal processing circuitry (Fig. 1, paragraph [0023], processor(s) 3) is configured to:
determine a morphology matching score between a previously established morphology template corresponding to a cardiac event signal and an unknown event signal in the cardiac electrical signal (paragraph [0044], "the morphology of the waveform of the candidate may be analyzed"; paragraph [0045], "a sample signal generated from a single ECG lead may be compared with a template stored in the physiological monitoring device"); and
compare the morphology matching score to a morphology match threshold for determining when the unknown event signal is the cardiac event signal (paragraphs [0062]-[0063]); and
the control circuit (Fig. 1, paragraph [0023], processor(s) 3) is configured to select the at least one operating parameter setting by:
determining that the medical lead type is different than a previously determined medical lead type (paragraph [0067], "during lead cross-check 602, when two pace pulse signals generated from independent ECG leads are found to be matched, they may be validated"); and
re-establishing the morphology template from the cardiac electrical signal in response to determining that the medical lead type is different than the previously determined medical lead type (paragraph [0048], "[the validated signal] may be integrated with previously-stored template to create an updated template or substitute an old template").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson '733 with the teachings of Chen so that the signal processing circuitry is further configured to: determining a morphology matching score between a previously established morphology template corresponding to a cardiac event signal and an unknown event signal in the cardiac electrical signal; and compare the morphology matching score to a morphology match threshold for determining when the unknown event signal is the cardiac event signal; and the control circuit is further configured to select the at least one operating parameter setting by: determining that the medical lead type is different than a previously determined medical lead type; and re-establishing the morphology template from the cardiac electrical signal in response to determining that the medical lead type is different than the previously determined medical lead type, because doing so improves detection of pace pulses from pacemakers with reduced false-negative rate and/or capability of rejecting false pulse signals with reduced false-positive rate (Chen, paragraph [0005]).
Regarding claim 21, Gunderson '733 discloses the non-transitory computer readable medium of claim 13, as explained above. Gunderson '733 does not explicitly disclose instructions that cause the medical device to: process the cardiac electrical signal to determine a morphology matching score between a previously established morphology template corresponding to a cardiac event signal and an unknown event signal in the cardiac electrical signal; compare the morphology matching score to a morphology match threshold for determining when the unknown event signal is the cardiac event signal; and select the at least one operating parameter setting by: determining that the medical lead type is different than a previously determined medical lead type; and re-establishing the morphology template from the cardiac electrical signal in response to determining that the medical lead type is different than the previously determined medical lead type.
However, Chen teaches an apparatus and method for detecting a pace pulse signal (Abstract) comprising instructions to:
process the cardiac electrical signal to determine a morphology matching score between a previously established morphology template corresponding to a cardiac event signal and an unknown event signal in the cardiac electrical signal (paragraph [0044], "the morphology of the waveform of the candidate may be analyzed"; paragraph [0045], "a sample signal generated from a single ECG lead may be compared with a template stored in the physiological monitoring device"); and
compare the morphology matching score to a morphology match threshold for determining when the unknown event signal is the cardiac event signal (paragraphs [0062]-[0063]); and
select the at least one operating parameter setting by:
determining that the medical lead type is different than a previously determined medical lead type (paragraph [0067], "during lead cross-check 602, when two pace pulse signals generated from independent ECG leads are found to be matched, they may be validated"); and
re-establishing the morphology template from the cardiac electrical signal in response to determining that the medical lead type is different than the previously determined medical lead type (paragraph [0048], "[the validated signal] may be integrated with previously-stored template to create an updated template or substitute an old template").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson '733 with the teachings of Chen to include instructions that cause the medical device to: process the cardiac electrical signal to determine a morphology matching score between a previously established morphology template corresponding to a cardiac event signal and an unknown event signal in the cardiac electrical signal; compare the morphology matching score to a morphology match threshold for determining when the unknown event signal is the cardiac event signal; and select the at least one operating parameter setting by: determining that the medical lead type is different than a previously determined medical lead type; and re-establishing the morphology template from the cardiac electrical signal in response to determining that the medical lead type is different than the previously determined medical lead type, because doing so improves detection of pace pulses from pacemakers with reduced false-negative rate and/or capability of rejecting false pulse signals with reduced false-positive rate (Chen, paragraph [0005]).
Claims 11 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson (US 20060116733 A1, previously cited), hereinafter Gunderson '733, in view of Gunderson et al. (US 8521269 B1, previously cited), hereinafter Gunderson '269.
Regarding claim 11, Gunderson '733 discloses the medical device of claim 1, as explained above. Gunderson '733 further discloses a telemetry circuit configured to transmit data signals (paragraph [0043], telemetry circuit 330), but does not explicitly disclose that the control circuit is further configured to set at least one report parameter based on the determined lead type; and the telemetry circuit is configured to transmit the report parameter to another medical device for use in generating a display of a graphical user interface.
However, Gunderson '269 teaches a system and method for selecting tachyarrhythmia detection parameters used by a medical device (Abstract) comprising a telemetry circuit (Fig. 2, column 3, line 58) configured to transmit data signals (column 5, lines 12-14), wherein:
the control circuit is further configured to set at least one report parameter based on the determined lead type (column 13, lines 38-42); and
the telemetry circuit is configured to transmit the report parameter to another medical device for use in generating a display of a graphical user interface (Fig. 2, column 5, lines 54-57, user interface 136).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson '733 with the teachings of Gunderson '269 so that the control circuit is further configured to set at least one report parameter based on the determined lead type; and the telemetry circuit is configured to transmit the report parameter to another medical device for use in generating a display of a graphical user interface, because doing so allows the user to make an informed decision in specifying a required sensitivity that may result in a trade-off of lower specificity (Gunderson '269, column 12, lines 7-8).
Regarding claim 23, Gunderson '733 discloses the non-transitory computer readable medium of claim 13, as explained above. Gunderson '733 does not explicitly disclose instructions that cause the medical device to: set at least one report parameter based on the determined lead type; and transmit a report comprising the report parameter to another medical device for use in generating a display of a graphical user interface.
However, Gunderson '269 teaches a system and method for selecting tachyarrhythmia detection parameters used by a medical device (Abstract) comprising a telemetry circuit (Fig. 2, column 3, line 58) configured to transmit data signals (column 5, lines 12-14), wherein:
the control circuit is further configured to set at least one report parameter based on the determined lead type (column 13, lines 38-42); and
the telemetry circuit is configured to transmit the report parameter to another medical device for use in generating a display of a graphical user interface (Fig. 2, column 5, lines 54-57, user interface 136).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gunderson '733 with the teachings of Gunderson '269 to include instructions that cause the medical device to: set at least one report parameter based on the determined lead type; and transmit a report comprising the report parameter to another medical device for use in generating a display of a graphical user interface, because doing so allows the user to make an informed decision in specifying a required sensitivity that may result in a trade-off of lower specificity (Gunderson '269, column 12, lines 7-8).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/CHRISTINE SISON/Examiner, Art Unit 3796
/PAMELA M. BAYS/Primary Examiner, Art Unit 3796
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