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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Eligibility Step 1 – The Four Categories of Statutory Subject Matter
Claims 1-9 and 18-20 fall within one of the four categories of statutory subject matter. Claims 1-9 are drawn to “a method” (i.e., a process) and claims 18-20 are drawn to “a system” (i.e., a machine), and thus fall within one of the four statutory categories.
Eligibility Step 2A, Prong One
Claims 1-9 and 18-20 recite an abstract idea:
Regarding independent claims 1 and 18, the limitations of “recurrently calculating … impedances,” “comparing the calculated impedances to one or more specified impedance values,” and “producing an alert … by a predetermined threshold impedance value” in independent claim 1 and the limitations of “the control circuit … recurrently initiat[ing] an impedance measurement between the housing electrode and each of the pacing electrodes of the lead,” “compar[ing] the calculated impedances to one or more specified impedance values,” and “produc[ing] an alert regarding placement of the implantable lead in response to the calculated impedance” in independent claim 18 are directed to an abstract idea. The limitations, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitation in the mind except for the recitation of “medical device” in independent claims 1 and 18. The limitations of “housing of the medical device and each of multiple pacing electrodes” are associated with calculated impedance values and these structural limitations are not performing any of the steps recited in the claims. For the limitation of the medical device, the specification discloses that the control circuit part (impedance circuit) of the medical device performs the calculation step (¶[0058]) and the control circuit may include any combination of hardware, firmware, or software (¶[0055]). Therefore, the part of the medical device performing the calculation step is nothing more than a generic computer function of processing data. That is, other than reciting that a “medical device” is performing these tasks, nothing in the claim precludes the steps from practically being performed in the human mind or being considered as methods of organizing human activity.
This claim language is identified as an abstract idea. MPEP 2106.04(a)(2)(II) states that the sub-grouping "managing personal behavior or relationships or interactions between people" include social activities, teaching, and following rules or instructions and MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea.
In the instant case, aside from the recitations of “medical device” language, the language reads on a human performing the claimed observation and analysis to provide a verbal alert. Producing an alert does not require any structure to perform the step, where a person or medical professional may provide a verbal alert, such that the claims are directed to organizing human activity. Furthermore, the claim encompasses aiding the medical professional in computing and evaluating parameters associated with cardiac function (mental process) to determine and communicate the cardiac condition of a patient (organizing human activity). The claims do not require the use of a computer beyond the recitation of a general-purpose processor to gather information about a subject, therefore they are not self-evidently patent eligible.
Eligibility Step 2A, Prong Two
Claims 1-9 and 18-20 do not recite additional elements that integrate the judicial exception into a practical application:
Regarding independent claims 1 and 18, the limitation of and “a housing” generally links the use of the mental process to a particular field and the limitation of “a medical device” generally links the use of the mental process to a particular field and merely uses a computer as a tool to perform the mental process.
Regarding independent claim 18, the limitations of “an implantable lead,” “electronic circuits,” “a sensing circuit,” “a control circuit,” and “an impedance measurement circuit” generally link the use of the mental process to a particular field and merely uses a computer as a tool to perform the mental process.
Eligibility Step 2B
Claims 1 and 18 do not amount to significantly more than the abstract ideas recited therein:
Regarding independent claim 1, the limitation of “a pacing electrode” generally links the use of the mental process to a particular field and merely uses a computer as a tool to perform the mental process. Regarding independent claims 1 and 18, the limitations of “a housing electrode,” “multiple pacing electrodes,” and “a left bundle branch pacing electrode” generally link the use of the mental process to a particular field and merely uses a computer as a tool to perform the mental process. Regarding independent claim 18, the limitation of “a therapy circuit” generally links the use of the mental process to a particular field and merely uses a computer as a tool to perform the mental process. For example, in Hauser et al. (hereinafter “Hauser”) (U.S. Pub. No. 2002/0091418 A1), cardiac stimulators for electrical stimulation are well-known, where Hauser teaches electrodes for electrical stimulation are well known in the art (¶[0003], where “Electrodes implanted in the body for electrical stimulation of muscle or body organs are well known. More specifically, electrodes implanted on or about the heart have been used to reverse certain abnormal and life-threatening arrhythmias. Electrical energy is applied to the heart via the electrodes to return the heart to normal sinus rhythm”).
Regarding dependent claims 2-9 and 19-20, the limitations of these claims further define the limitations already indicated as being directed to the abstract idea as recited in claims 1 and 18.
Dependent claims 2-9 and 19-20 further define the abstract idea.
Therefore, these additional elements do not amount to significantly more than the judicial exception and the claimed subject matter appears to be ineligible under §101.
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.
Claims 1-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Prutchi (U.S. Pub. No. 2022/0370812 A1) in view of An et al. (hereinafter “An”) (U.S. Pub. No. 2015/0351660 A1) and Mangual-Soto et al. (hereinafter “Man”) (U.S. Pub. No. 2023/0008264 A1).
Regarding claim 1, Prutchi teaches a method (Abstract, which teaches “a method of testing a lead condition in an implanted cardiac device”) comprising:
recurrently calculating (¶[0073], where “assessment of the lead condition via impedance measurements is performed periodically and/or at pre-set timing and/or at pre-set intervals, for example every 5 minutes, every 50 minutes, every 30 minutes, every hour, every 4 hours, every 12 hours, every 24 hours, every 2 days, every week, or intermediate, longer or shorter time intervals”), by a medical device (¶[0041], where “there is provided an implantable cardiac device comprising … circuitry for controlling and activating the defibrillation lead and the non-defibrillation lead and for measuring impedance”), impedances between a housing of the medical device and a pacing electrode (¶[0025], where “the invention there is provided a method of testing lead integrity in an implantable cardiac device comprising at least one lead including at least two electrodes … measuring impedance between the at least two electrodes and/or between an electrode and the device housing; and determining a condition of the lead according to the measured impedance value,” ¶[0045], where “estimate, according to a difference between a currently measured impedance level measured between the at least one electrode of the non-defibrillation lead and the coil of the defibrillation lead and one or both of the baseline impedance measurements, a current impedance between the coil of the defibrillation lead and the housing; and assess a condition of the defibrillation lead based on the estimated current impedance,” ¶[0067], where “the non-defibrillation lead comprises a pacing lead”);
comparing the calculated impedances to one or more specified impedance values (¶[0041]-¶[0042], which teaches “an implantable cardiac device comprising … circuitry for controlling and activating the defibrillation lead and the non-defibrillation lead and for measuring impedance, the circuitry configured to … apply a test pulse to measure a baseline impedance between the coil of the defibrillation lead and the housing,” ¶[0045], where the circuitry is configured to “estimate, according to a difference between a currently measured impedance level measured between the at least one electrode of the non-defibrillation lead and the coil of the defibrillation lead and one or both of the baseline impedance measurements, a current impedance between the coil of the defibrillation lead and the housing; and assess a condition of the defibrillation lead based on the estimated current impedance”); and
producing an alert regarding placement of a pacing electrode (¶[0121], where “The leads of an active implanted cardiac device are, in some cases, most prone to failure, for example as compared to other components of the device. Lead failures or defects, such as a cut-off in the lead wire or a hole in the lead insulation sheath may form due to tension on the lead, body movements, blood flow in contact with the lead, and/or other ... for maintaining a safe and functioning system it is desired to provide for quick and efficient detection of a lead condition (e.g. fracture, dislodgment, connectivity problem, insulation problem, deformation or the like), ¶[0122], where “impedance measurements may allow for detecting the condition of the lead, due to that the measured impedance value is affected by defects (such as mentioned above) and deviates from an expected or normal value or range … the fluctuations in impedance are caused as a result of a change of body posture, movement, breathing and/or heart pulsation, which may move the lead(s) and/or associated circuitry”) in response to a calculated impedance corresponding to the pacing electrode differing from the one or more specified impedance values by a predetermined threshold impedance value (¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, higher than a set threshold, lower than a set threshold, not within a desired or predefined range,” ¶[0164] - ¶[0169], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead. In an example, thresholds are set as follows: Inappropriately LOW impedance if Estimated Impedance<25 Ω, Impedance OK if 25Ω≤Estimated Impedance≤100 Ω, Inappropriately HIGH impedance if Estimated Impedance>100 Ω ... when impedance is found not to be within an expected range, an alert and/or other notification are generated”).
Although Prutchi teaches calculating, by a medical device, impedances between a housing of the medical device and a pacing electrode of a lead, where the lead includes at least two electrodes, Prutchi does not explicitly teach calculating impedances between a housing electrode included in a housing of the medical device and each of multiple pacing electrodes, wherein the multiple pacing electrodes include a left bundle branch pacing electrode configured for placement in a left bundle branch of a subject.
An teaches an apparatus and methods that may include a sensing circuit configured to generate a sensed physiological signal representative of thoracic impedance of a subject and a controller circuit (Abstract, ¶[0004]), and further teaches calculating impedances between a housing electrode included in a housing of the medical device and each of multiple pacing electrodes (¶[0026], where “The device 400 can be implantable and the sensing circuit 405 and stimulus circuit 410 can be electrically coupled to electrodes that are implantable, such as the example electrodes of FIG.1. The stimulus circuit 410 can also be used to provide electrical cardiac therapy to the heart of the subject such as electrical pacing therapy,” ¶[0031], where “sensing circuit 405 can be electrically coupled to different electrodes to determine absolute thoracic impedance using different sensing vectors … the sensing vector can include an electrode configured for placement in or near the left ventricle (LV) of the heart (e.g., any of electrodes 160 and 165 placed in a coronary vein lying epicardially on LV) and the housing electrode 111 (LVCan),” ¶[0032], where “the sensing circuit 405 can be electrically connectable to a plurality of sensing vectors useable to generate a plurality of physiological signals representative of thoracic impedance. For instance, the device 400 may include a switching circuit (not shown) to electrically couple different combinations of electrodes to the sensing circuit 405”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of An, which teaches calculating impedances between a housing electrode included in a housing of the medical device and each of multiple pacing electrodes, with the invention of Prutchi in order to allow the sensing circuit to sense physiological signals in different directions (An ¶[0032]).
Although Prutchi teaches a pacing electrode and An teaches multiple pacing electrodes configured for placement in or near the left ventricle, where Examiner notes that the left bundle branch is located within the left ventricle, neither Prutchi nor An explicitly teach that the pacing electrode includes a left bundle branch pacing electrode configured for placement in a left bundle branch of a subject.
Man teaches a method that includes obtaining impedance data indicative of an impedance along an impedance monitoring (IM) vector with a first electrode located at different depths within a septal wall (¶[0008]), and further teaches that the pacing electrode includes a left bundle branch pacing electrode configured for placement in a left bundle branch of a subject (¶[0006], where “Optionally, the target depth locates the first electrode proximate to the left bundle branch (LBB) … the one or more processors are configured to determine that the first electrode is located proximate the LBB when the impedance data decreases from a first data value above a threshold to a second data value below the threshold”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Man, which teaches that the pacing electrode includes a left bundle branch pacing electrode configured for placement in a left bundle branch of a subject, with the modified invention of Prutchi in order to monitor a region of interest within the heart's conductive pathways without penetrating the distal end wall of the corresponding chamber (Man ¶[0034]), where criteria of interest include determination of a maximum impedance measurement (Man ¶[0083]).
Regarding claim 2, Prutchi in combination with An and Man teaches all limitations of claim 1 as described in the rejection above.
Prutchi teaches recurrently calculating the impedances (¶[0073], where “assessment of the lead condition via impedance measurements is performed periodically and/or at pre-set timing and/or at pre-set intervals, for example every 5 minutes, every 50 minutes, every 30 minutes, every hour, every 4 hours, every 12 hours, every 24 hours, every 2 days, every week, or intermediate, longer or shorter time intervals”) between the housing and an electrode of an implantable lead that includes the pacing electrode (¶[0025], where “the invention there is provided a method of testing lead integrity in an implantable cardiac device comprising at least one lead including at least two electrodes … measuring impedance between the at least two electrodes and/or between an electrode and the device housing; and determining a condition of the lead according to the measured impedance value”); and
wherein producing the alert includes producing the alert regarding placement of the pacing electrode (¶[0121], where “The leads of an active implanted cardiac device are, in some cases, most prone to failure, for example as compared to other components of the device. Lead failures or defects, such as a cut-off in the lead wire or a hole in the lead insulation sheath may form due to tension on the lead, body movements, blood flow in contact with the lead, and/or other ... for maintaining a safe and functioning system it is desired to provide for quick and efficient detection of a lead condition (e.g. fracture, dislodgment, connectivity problem, insulation problem, deformation or the like), ¶[0122], where “impedance measurements may allow for detecting the condition of the lead, due to that the measured impedance value is affected by defects (such as mentioned above) and deviates from an expected or normal value or range … the fluctuations in impedance are caused as a result of a change of body posture, movement, breathing and/or heart pulsation, which may move the lead(s) and/or associated circuitry”) when the calculated impedance of the pacing electrode is greater than the one or more specified impedance values by the predetermined threshold impedance value (¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, higher than a set threshold,” ¶[0164], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead,” ¶[0165], ¶[0168]-¶[0169], where “In an example, thresholds are set as follows: … Inappropriately HIGH impedance if Estimated Impedance>100 Ω ... when impedance is found not to be within an expected range, an alert and/or other notification are generated”).
An teaches calculating the impedances between the housing electrode and each electrode of an implantable lead that includes the multiple pacing electrodes (¶[0026], where “The device 400 can be implantable and the sensing circuit 405 and stimulus circuit 410 can be electrically coupled to electrodes that are implantable, such as the example electrodes of FIG.1. The stimulus circuit 410 can also be used to provide electrical cardiac therapy to the heart of the subject such as electrical pacing therapy,” ¶[0031], where “sensing circuit 405 can be electrically coupled to different electrodes to determine absolute thoracic impedance using different sensing vectors … the sensing vector can include an electrode configured for placement in or near the left ventricle (LV) of the heart (e.g., any of electrodes 160 and 165 placed in a coronary vein lying epicardially on LV) and the housing electrode 111 (LVCan),” ¶[0032], where “the sensing circuit 405 can be electrically connectable to a plurality of sensing vectors useable to generate a plurality of physiological signals representative of thoracic impedance. For instance, the device 400 may include a switching circuit (not shown) to electrically couple different combinations of electrodes to the sensing circuit 405”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of An, which teaches calculating the impedances between the housing electrode and each electrode of an implantable lead that includes the multiple pacing electrodes, with the modified invention of Prutchi in order to allow the sensing circuit to sense physiological signals in different directions (An ¶[0032]).
Man teaches the left bundle branch pacing electrode (¶[0006], where “Optionally, the target depth locates the first electrode proximate to the left bundle branch (LBB) … the one or more processors are configured to determine that the first electrode is located proximate the LBB when the impedance data decreases from a first data value above a threshold to a second data value below the threshold”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Man, which teaches the left bundle branch pacing electrode, with the modified invention of Prutchi in order to monitor a region of interest within the heart's conductive pathways without penetrating the distal end wall of the corresponding chamber (Man ¶[0034]), where criteria of interest include determination of a maximum impedance measurement (Man ¶[0083]).
Regarding claim 3, Prutchi in combination with An and Man teaches all limitations of claim 2 as described in the rejection above.
Prutchi teaches recurrently calculating the impedances (¶[0073], where “assessment of the lead condition via impedance measurements is performed periodically and/or at pre-set timing and/or at pre-set intervals, for example every 5 minutes, every 50 minutes, every 30 minutes, every hour, every 4 hours, every 12 hours, every 24 hours, every 2 days, every week, or intermediate, longer or shorter time intervals”) between the housing and an electrode of an implantable lead that includes the pacing electrode (¶[0025], where “the invention there is provided a method of testing lead integrity in an implantable cardiac device comprising at least one lead including at least two electrodes … measuring impedance between the at least two electrodes and/or between an electrode and the device housing; and determining a condition of the lead according to the measured impedance value”) and another lead electrode configured for bipolar pacing with the pacing electrode (¶[0067], where “the non-defibrillation lead comprises a cardiac contractility modulation lead.” Examiner interprets that a cardiac contractility modulation lead is a type of bipolar pacing lead electrode.); and
wherein producing the alert includes producing the alert regarding placement of the implantable lead (¶[0121], where “The leads of an active implanted cardiac device are, in some cases, most prone to failure, for example as compared to other components of the device. Lead failures or defects, such as a cut-off in the lead wire or a hole in the lead insulation sheath may form due to tension on the lead, body movements, blood flow in contact with the lead, and/or other ... for maintaining a safe and functioning system it is desired to provide for quick and efficient detection of a lead condition (e.g. fracture, dislodgment, connectivity problem, insulation problem, deformation or the like), ¶[0122], where “impedance measurements may allow for detecting the condition of the lead, due to that the measured impedance value is affected by defects (such as mentioned above) and deviates from an expected or normal value or range … the fluctuations in impedance are caused as a result of a change of body posture, movement, breathing and/or heart pulsation, which may move the lead(s) and/or associated circuitry”) when the calculated impedance of at least one of the pacing electrode and the other lead electrode is greater than the one or more specified impedance values by the predetermined threshold impedance value (¶[0043], where the circuitry is configured to “apply a test pulse to measure a baseline impedance between the at least one electrode of the non-defibrillation lead and the coil of the defibrillation lead,” ¶[0045], where the circuitry is configured to “estimate, according to a difference between a currently measured impedance level measured between the at least one electrode of the non-defibrillation lead and the coil of the defibrillation lead and one or both of the baseline impedance measurements, a current impedance between the coil of the defibrillation lead and the housing; and assess a condition of the defibrillation lead based on the estimated current impedance,” ¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, higher than a set threshold,” ¶[0164], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead,” ¶[0165], ¶[0168]-¶[0169], where “In an example, thresholds are set as follows: … Inappropriately HIGH impedance if Estimated Impedance>100 Ω ... when impedance is found not to be within an expected range, an alert and/or other notification are generated”).
An teaches calculating the impedances between the housing electrode and another lead electrode configured for pacing (¶[0026], where “The device 400 can be implantable and the sensing circuit 405 and stimulus circuit 410 can be electrically coupled to electrodes that are implantable, such as the example electrodes of FIG.1. The stimulus circuit 410 can also be used to provide electrical cardiac therapy to the heart of the subject such as electrical pacing therapy,” ¶[0031], where “sensing circuit 405 can be electrically coupled to different electrodes to determine absolute thoracic impedance using different sensing vectors … the sensing vector can include an electrode configured for placement in or near the left ventricle (LV) of the heart (e.g., any of electrodes 160 and 165 placed in a coronary vein lying epicardially on LV) and the housing electrode 111 (LVCan),” ¶[0032], where “the sensing circuit 405 can be electrically connectable to a plurality of sensing vectors useable to generate a plurality of physiological signals representative of thoracic impedance. For instance, the device 400 may include a switching circuit (not shown) to electrically couple different combinations of electrodes to the sensing circuit 405”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of An, which teaches calculating the impedances between the housing electrode and another lead electrode configured for pacing, with the modified invention of Prutchi in order to allow the sensing circuit to sense physiological signals in different directions (An ¶[0032]).
Man teaches the left bundle branch pacing electrode (¶[0006], where “Optionally, the target depth locates the first electrode proximate to the left bundle branch (LBB) … the one or more processors are configured to determine that the first electrode is located proximate the LBB when the impedance data decreases from a first data value above a threshold to a second data value below the threshold”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Man, which teaches the left bundle branch pacing electrode, with the modified invention of Prutchi in order to monitor a region of interest within the heart's conductive pathways without penetrating the distal end wall of the corresponding chamber (Man ¶[0034]), where criteria of interest include determination of a maximum impedance measurement (Man ¶[0083]).
Regarding claim 4, Prutchi in combination with An and Man teaches all limitations of claim 3 as described in the rejection above. Furthermore, regarding claim 4, see the rejection of claim 2 above which teaches “the calculated impedance between the housing electrode and the left bundle branch pacing electrode”.
Prutchi teaches that the producing the alert includes producing the alert when the calculated impedance between the housing and the pacing electrode is less than the specified impedance by the predetermined threshold impedance value (¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, … lower than a set threshold,” ¶[0164], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead,” ¶[0165]-¶[0166], where “In an example, thresholds are set as follows: Inappropriately LOW impedance if Estimated Impedance<25 Ω,” ¶[0169], where “when impedance is found not to be within an expected range, an alert and/or other notification are generated”).
Regarding claim 5, Prutchi in combination with An and Man teaches all limitations of claim 1 as described in the rejection above.
Prutchi teaches the medical device activating the calculating of the impedances in response to the medical device determining presence of the left bundle branch pacing electrode (¶[0041], where the device comprises “circuitry for controlling and activating the defibrillation lead and the non-defibrillation lead and for measuring impedance.” Examiner interprets that the circuitry inherently activates when the pacing electrode is attached to the lead and consequently the circuitry as the device could not function to measure electrode impedances if the electrode is not a part of, or present in, the device, where the left bundle branch pacing electrode is taught by Man as stated in the rejection of claim 1.).
Regarding claim 6, Prutchi in combination with An and Man teaches all limitations of claim 5 as described in the rejection above.
Prutchi teaches the medical device activating the recurrent calculating of the impedances a specified duration of time after determining presence of the left bundle branch pacing electrode (¶[0073], where “assessment of the lead condition via impedance measurements is performed periodically and/or at pre-set timing and/or at pre-set intervals, for example every 5 minutes, every 50 minutes, every 30 minutes, every hour, every 4 hours, every 12 hours, every 24 hours, every 2 days, every week, or intermediate, longer or shorter time intervals”).
Regarding claim 9, Prutchi in combination with An and Man teaches all limitations of claim 1 as described in the rejection above.
Prutchi teaches measuring, by the medical device (¶[0041], where “there is provided an implantable cardiac device comprising … circuitry for controlling and activating the defibrillation lead and the non-defibrillation lead and for measuring impedance”), a baseline impedance value between the housing and the pacing electrode (¶[0042], where the circuitry is configured to “apply a test pulse to measure a baseline impedance between the coil of the defibrillation lead and the housing”); and
using the measured baseline impedance value as the specified impedance value for the pacing electrode (¶[0045], where the circuitry is configured to “estimate, according to a difference between a currently measured impedance level measured between the at least one electrode of the non-defibrillation lead and the coil of the defibrillation lead and one or both of the baseline impedance measurements, a current impedance between the coil of the defibrillation lead and the housing; and assess a condition of the defibrillation lead based on the estimated current impedance”).
An teaches a housing electrode (¶[0031], where “the sensing vector can include an electrode configured for placement in or near the left ventricle (LV) of the heart (e.g., any of electrodes 160 and 165 placed in a coronary vein lying epicardially on LV) and the housing electrode 111 (LVCan)”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of An, which teaches a housing electrode, with the modified invention of Prutchi in order to allow the sensing circuit to sense physiological signals in different directions by providing another sensing vector (An ¶[0032]).
Man teaches the left bundle branch pacing electrode (¶[0006], where “Optionally, the target depth locates the first electrode proximate to the left bundle branch (LBB) … the one or more processors are configured to determine that the first electrode is located proximate the LBB when the impedance data decreases from a first data value above a threshold to a second data value below the threshold”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Man, which teaches the left bundle branch pacing electrode, with the modified invention of Prutchi in order to monitor a region of interest within the heart's conductive pathways without penetrating the distal end wall of the corresponding chamber (Man ¶[0034]), where criteria of interest include determination of a maximum impedance measurement (Man ¶[0083]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Prutchi, An, and Man as applied to claim 1 above, and further in view of Sison et al. (hereinafter “Sison”) (U.S. Pub. No. 2024/0050738 A1).
Regarding claim 7, Prutchi in combination with An and Man teaches all limitations of claim 1 as described in the rejection above.
Prutchi teaches the calculated impedance differing from the specified impedance by more than the predetermined threshold impedance value (¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, higher than a set threshold,” ¶[0164], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead,” ¶[0165], ¶[0168]-¶[0169], where “In an example, thresholds are set as follows: … Inappropriately HIGH impedance if Estimated Impedance>100 Ω ... when impedance is found not to be within an expected range, an alert and/or other notification are generated”); and
producing the alert regarding placement of the pacing electrode (¶[0121], where “The leads of an active implanted cardiac device are, in some cases, most prone to failure, for example as compared to other components of the device. Lead failures or defects, such as a cut-off in the lead wire or a hole in the lead insulation sheath may form due to tension on the lead, body movements, blood flow in contact with the lead, and/or other ... for maintaining a safe and functioning system it is desired to provide for quick and efficient detection of a lead condition (e.g. fracture, dislodgment, connectivity problem, insulation problem, deformation or the like), ¶[0122], where “impedance measurements may allow for detecting the condition of the lead, due to that the measured impedance value is affected by defects (such as mentioned above) and deviates from an expected or normal value or range … the fluctuations in impedance are caused as a result of a change of body posture, movement, breathing and/or heart pulsation, which may move the lead(s) and/or associated circuitry”) includes producing the alert in response to the calculated impedance differing from the specified impedance by the predetermined threshold impedance value (¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, higher than a set threshold, lower than a set threshold, not within a desired or predefined range,” ¶[0164] - ¶[0169], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead. In an example, thresholds are set as follows: Inappropriately LOW impedance if Estimated Impedance<25 Ω, Impedance OK if 25Ω≤Estimated Impedance≤100 Ω, Inappropriately HIGH impedance if Estimated Impedance>100 Ω ... when impedance is found not to be within an expected range, an alert and/or other notification are generated”).
None of Prutchi, An, nor Man teach initiating a capture threshold test in response to the differing calculated impedance nor producing the alert in response to a detected change in the capture threshold.
Sison teaches a method for automatically operating an active implantable medical device (AIMD) (Abstract), and further teaches initiating a capture threshold test in response to the differing calculated impedance (¶[0007], where “the one or more processors are further configured to periodically check an operation of the AIMD … periodically checking operation of the AIMD includes determining a lead impedance of the AIMD or determining a pacing capture threshold communicating an alert based on a value of the lead impedance or the pacing capture threshold,” ¶[0037], where “The term “AIMD” shall mean an active implantable medical device … Non-limiting examples of AIMDs include one or more of cardiac implantable electronic devices, neurostimulator devices, implantable leadless monitoring and/or therapy devices, and/or alternative implantable medical devices. For example, the AIMD may represent a cardiac monitoring device, leaded pacemaker, cardioverter, cardiac rhythm management device, defibrillator, neurostimulator, leadless monitoring device, leadless pacemaker, and the like,” ¶[0078], where “at 714 the AIMD conducts periodic auto checks including in one example, the AIMD lead impedance, and pacing capture threshold (PCT).” Examiner interprets that a capture threshold test is in response to the differing calculated impedance since both thresholds are measured, where the measurements include subsequent measuring of the pacing capture threshold. This is because the auto checks are periodic and can pertain to either the lead impedance or pacing capture threshold such that the pacing capture threshold will be subsequent to the lead impedance measurement during said periodic auto checks.); and
producing the alert in response to a detected change in the capture threshold (¶[0007], where “the one or more processors are further configured to periodically check an operation of the AIMD … periodically checking operation of the AIMD includes determining … a pacing capture threshold communicating an alert based on a value of the … pacing capture threshold”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Sison, which teaches initiating a capture threshold test in response to the differing calculated impedance and producing the alert in response to a detected change in the capture threshold, with the modified invention of Prutchi in order to periodically check operation of the AIMD (Sison ¶[0007]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Prutchi, An, and Man as applied to claim 1 above, and further in view of Gunderson (U.S. Pat. No. 9,199,078 B1).
Regarding claim 8, Prutchi in combination with An and Man teaches all limitations of claim 1 as described in the rejection above.
Prutchi teaches the calculated impedance differing from the specified impedance by more than the predetermined threshold impedance value (¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, higher than a set threshold,” ¶[0164], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead,” ¶[0165], ¶[0168]-¶[0169], where “In an example, thresholds are set as follows: … Inappropriately HIGH impedance if Estimated Impedance>100 Ω ... when impedance is found not to be within an expected range, an alert and/or other notification are generated”); and
producing the alert regarding placement of the pacing electrode (¶[0121], where “The leads of an active implanted cardiac device are, in some cases, most prone to failure, for example as compared to other components of the device. Lead failures or defects, such as a cut-off in the lead wire or a hole in the lead insulation sheath may form due to tension on the lead, body movements, blood flow in contact with the lead, and/or other ... for maintaining a safe and functioning system it is desired to provide for quick and efficient detection of a lead condition (e.g. fracture, dislodgment, connectivity problem, insulation problem, deformation or the like), ¶[0122], where “impedance measurements may allow for detecting the condition of the lead, due to that the measured impedance value is affected by defects (such as mentioned above) and deviates from an expected or normal value or range … the fluctuations in impedance are caused as a result of a change of body posture, movement, breathing and/or heart pulsation, which may move the lead(s) and/or associated circuitry”) includes producing the alert in response to the calculated impedance differing from the specified impedance by the predetermined threshold impedance value (¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, higher than a set threshold, lower than a set threshold, not within a desired or predefined range,” ¶[0164] - ¶[0169], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead. In an example, thresholds are set as follows: Inappropriately LOW impedance if Estimated Impedance<25 Ω, Impedance OK if 25Ω≤Estimated Impedance≤100 Ω, Inappropriately HIGH impedance if Estimated Impedance>100 Ω ... when impedance is found not to be within an expected range, an alert and/or other notification are generated”).
None of Prutchi, An, nor Man teach initiating a sensing threshold test in response to the differing calculated impedance nor producing the alert in response to a detected change in the sensing threshold.
Gunderson teaches an implantable medical device capable of sensing cardiac signals and delivering cardiac electrical stimulation therapies is enabled to detect a short circuit condition on a sensing or therapy vector (Abstract), and further teaches initiating a sensing threshold test in response to the differing calculated impedance (Figure 8, where the cardiac electrical signal is measured subsequent to, or in response to, an abnormal impedance, Col. 3, lines 17-19, where “FIG. 8 is a flow diagram illustrating example operation of an IMD monitoring cardiac electrical signals and lead impedance to identify lead-related problems,” Col. , lines , where “The steps or operations performed in blocks 500, 502, 504, 506, 508, 510, 520, and 522 are the same as described above with respect to FIGS. 4, 5, and 6”); and
producing the alert in response to a detected change in the sensing threshold (Figure 8, where the cardiac electrical signal is measured subsequent to, or in response to, an abnormal impedance and generates an alert if a problem is detected, Col. 18, lines 1-5, where “When control module 60 determines that there is a significant amplitude reduction in the coincident FF cardiac event (“YES” branch of block 508), control module 60 may detect a potential lead-related problem (e.g., short-circuit of conductor of the FF sensing vector) and generate an alert (510)”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Gunderson, which teaches initiating a sensing threshold test in response to the differing calculated impedance and producing the alert in response to a detected change in the sensing threshold, with the modified invention of Prutchi in order to alert the patient or a responder that immediate medical attention is required (Gunderson Col. 8, lines 32-33).
Claims 10-14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Prutchi in view of An, Man, and Gunderson.
Regarding claim 10, Prutchi teaches an apparatus (Abstract, which teaches “an implanted cardiac device comprising a first defibrillation lead and a second non-defibrillation lead”) comprising:
a therapy circuit configured to provide electrical pacing energy when operatively connected to a pacing electrode (¶[0040], where “the non-defibrillation lead comprises a cardiac contractility modulation (cardiac contractility modulation) lead or a pacing lead,” ¶[0041], where “there is provided an implantable cardiac device comprising … a non-defibrillation lead having at least one electrode … circuitry for controlling and activating the defibrillation lead and the non-defibrillation lead”);
a housing to contain electronic circuits of the apparatus (¶[0090], where “a housing 109, which encases, for example: powering means (e.g. a battery), control circuitry configured for timing and generating the electrical pulses, sensing circuitry, communication circuitry, memory means, and/or other”);
a sensing circuit (¶[0090], where “a housing 109, which encases, for example … sensing circuitry”); and
a control circuit operatively coupled to the therapy circuit and the sensing circuit (¶[0041], where “there is provided an implantable cardiac device comprising … a non-defibrillation lead having at least one electrode … circuitry for controlling and activating the defibrillation lead and the non-defibrillation lead.” Examiner interprets that the circuitry is included in one system such that all circuits are connected to one another.), and including an impedance measurement circuit configured to measure an impedance between the housing and the pacing electrode (¶[0041], where “there is provided an implantable cardiac device comprising: … circuitry for … measuring impedance”); wherein the control circuit is configured to:
recurrently initiate an impedance measurement (¶[0073], where “assessment of the lead condition via impedance measurements is performed periodically and/or at pre-set timing and/or at pre-set intervals, for example every 5 minutes, every 50 minutes, every 30 minutes, every hour, every 4 hours, every 12 hours, every 24 hours, every 2 days, every week, or intermediate, longer or shorter time intervals”) between the housing and the pacing electrode (¶[0025], where “the invention there is provided a method of testing lead integrity in an implantable cardiac device comprising at least one lead including at least two electrodes … measuring impedance between the at least two electrodes and/or between an electrode and the device housing; and determining a condition of the lead according to the measured impedance value,” ¶[0045], where “estimate, according to a difference between a currently measured impedance level measured between the at least one electrode of the non-defibrillation lead and the coil of the defibrillation lead and one or both of the baseline impedance measurements, a current impedance between the coil of the defibrillation lead and the housing; and assess a condition of the defibrillation lead based on the estimated current impedance,” ¶[0067], where “the non-defibrillation lead comprises a pacing lead”);
compare the calculated impedances to one or more specified impedance values (¶[0041]-¶[0042], which teaches “an implantable cardiac device comprising … circuitry for controlling and activating the defibrillation lead and the non-defibrillation lead and for measuring impedance, the circuitry configured to … apply a test pulse to measure a baseline impedance between the coil of the defibrillation lead and the housing,” ¶[0045], where the circuitry is configured to “estimate, according to a difference between a currently measured impedance level measured between the at least one electrode of the non-defibrillation lead and the coil of the defibrillation lead and one or both of the baseline impedance measurements, a current impedance between the coil of the defibrillation lead and the housing; and assess a condition of the defibrillation lead based on the estimated current impedance”); and
produce an alert regarding placement of a pacing electrode (¶[0121], where “The leads of an active implanted cardiac device are, in some cases, most prone to failure, for example as compared to other components of the device. Lead failures or defects, such as a cut-off in the lead wire or a hole in the lead insulation sheath may form due to tension on the lead, body movements, blood flow in contact with the lead, and/or other ... for maintaining a safe and functioning system it is desired to provide for quick and efficient detection of a lead condition (e.g. fracture, dislodgment, connectivity problem, insulation problem, deformation or the like), ¶[0122], where “impedance measurements may allow for detecting the condition of the lead, due to that the measured impedance value is affected by defects (such as mentioned above) and deviates from an expected or normal value or range … the fluctuations in impedance are caused as a result of a change of body posture, movement, breathing and/or heart pulsation, which may move the lead(s) and/or associated circuitry”) in response to the calculated impedance corresponding to the pacing electrode differing from the one or more specified impedances by a predetermined threshold impedance value (¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, higher than a set threshold, lower than a set threshold, not within a desired or predefined range,” ¶[0164] - ¶[0169], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead. In an example, thresholds are set as follows: Inappropriately LOW impedance if Estimated Impedance<25 Ω, Impedance OK if 25Ω≤Estimated Impedance≤100 Ω, Inappropriately HIGH impedance if Estimated Impedance>100 Ω ... when impedance is found not to be within an expected range, an alert and/or other notification are generated”).
Although Prutchi teaches calculating impedances between a housing and a pacing electrode of a lead, where the lead includes at least two electrodes, Prutchi does not explicitly teach providing electrical pacing energy to a left bundle branch of a subject when operatively connected to multiple pacing electrodes including a left bundle branch pacing electrode; a housing electrode formed on the housing; sensing at least one of voltage or current of each of the pacing electrodes relative to the housing electrode; nor measuring an impedance between the housing electrode and each of the multiple pacing electrodes.
An teaches providing electrical pacing energy to multiple pacing electrodes (¶[0026], where “The device 400 can be implantable and the sensing circuit 405 and stimulus circuit 410 can be electrically coupled to electrodes that are implantable, such as the example electrodes of FIG.1. The stimulus circuit 410 can also be used to provide electrical cardiac therapy to the heart of the subject such as electrical pacing therapy”);
a housing electrode formed on the housing (¶[0031], where “sensing circuit 405 can be electrically coupled to different electrodes to determine absolute thoracic impedance using different sensing vectors … the sensing vector can include an electrode configured for placement in or near the left ventricle (LV) of the heart (e.g., any of electrodes 160 and 165 placed in a coronary vein lying epicardially on LV) and the housing electrode 111 (LVCan)”); and
measuring an impedance between the housing electrode and each of the multiple pacing electrodes (¶[0026], where “The device 400 can be implantable and the sensing circuit 405 and stimulus circuit 410 can be electrically coupled to electrodes that are implantable, such as the example electrodes of FIG.1. The stimulus circuit 410 can also be used to provide electrical cardiac therapy to the heart of the subject such as electrical pacing therapy,” ¶[0031], where “sensing circuit 405 can be electrically coupled to different electrodes to determine absolute thoracic impedance using different sensing vectors … the sensing vector can include an electrode configured for placement in or near the left ventricle (LV) of the heart (e.g., any of electrodes 160 and 165 placed in a coronary vein lying epicardially on LV) and the housing electrode 111 (LVCan),” ¶[0032], where “the sensing circuit 405 can be electrically connectable to a plurality of sensing vectors useable to generate a plurality of physiological signals representative of thoracic impedance. For instance, the device 400 may include a switching circuit (not shown) to electrically couple different combinations of electrodes to the sensing circuit 405”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of An, which teaches providing electrical pacing energy to multiple pacing electrodes; a housing electrode formed on the housing; and measuring an impedance between the housing electrode and each of the multiple pacing electrodes, with the invention of Prutchi in order to provide electrical cardiac therapy to the heart of the subject such as electrical pacing therapy (An ¶[[26]) and to allow the sensing circuit to sense physiological signals in different directions (An ¶[0032]).
Although Prutchi teaches a pacing electrode and An teaches multiple pacing electrodes configured for placement in or near the left ventricle, where Examiner notes that the left bundle branch is located within the left ventricle, neither Prutchi nor An explicitly teach providing electrical pacing energy to a left bundle branch of a subject when operatively connected to multiple pacing electrodes including a left bundle branch pacing electrode; nor sensing at least one of voltage or current of each of the pacing electrodes relative to the housing electrode.
Man teaches providing electrical pacing energy to a left bundle branch of a subject when operatively connected to a left bundle branch pacing electrode (¶[0006], where “Optionally, the target depth locates the first electrode proximate to the left bundle branch (LBB) … the one or more processors are configured to determine that the first electrode is located proximate the LBB when the impedance data decreases from a first data value above a threshold to a second data value below the threshold,” ¶[0067], where “after the lead has been advanced through a distal portion of the mid-septum wall 415 and the first electrode 428 is proximate the LBB. The third position represents the desired location of the lead 422 and first electrode 428 for providing therapy”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Man, which teaches providing electrical pacing energy to a left bundle branch of a subject when operatively connected to a left bundle branch pacing electrode, with the modified invention of Prutchi in order to monitor a region of interest within the heart's conductive pathways without penetrating the distal end wall of the corresponding chamber (Man ¶[0034]), where criteria of interest include determination of a maximum impedance measurement (Man ¶[0083]), and to provide therapy (Man ¶[0067]).
None of Prutchi, An, nor Man teaches sensing at least one of voltage or current of each of the pacing electrodes relative to the housing electrode.
Gunderson teaches sensing at least one of voltage or current of each of the pacing electrodes relative to the housing electrode (Col. 4, lines 9-21, where “Lead 18 includes electrodes 40 and 42 for sensing cardiac signals and delivering electrical stimulation therapy (e.g., pacing pulses) along the left ventricle (labeled “LV” in FIG. 1). In some examples, lead 18 may additionally carry electrodes for positioning along the left atrium for sensing and stimulation along the left atrial chamber (labeled “LA” in FIG. 1). Moreover, lead 18 may carry additional electrodes positioned along the left ventricle, e.g., four electrodes. In addition, housing or CAN electrode formed on housing 26 may be used as an active electrode in combination with electrodes 40 and/or 42 to deliver the electrical stimulation therapy and/or sense cardiac electrical signals along the left ventricle,” Col. 9, lines 58-65, Col. 10, lines 2-8, where “Control module 60 may perform an impedance measurement by controlling delivery, from LV therapy circuitry 64 or other signal generator, of a voltage pulse between first and second electrodes of the electrode vector of interest. Impedance measurement module 68 may measure a resulting current, and control module 60 may calculate a resistance based upon the voltage amplitude of the pulse and the measured amplitude of the resulting current ... impedance measurement module 68 may measure a resulting voltage, and control module 60 may calculate a resistance based upon the current amplitude of the pulse and the measured amplitude of the resulting voltage. Impedance measurement module 68 may include circuitry for measuring amplitudes of resulting currents or voltages, such as sample and hold circuitry”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Gunderson, which teaches sensing at least one of voltage or current of each of the pacing electrodes relative to the housing electrode, with the modified invention of Prutchi in order to deliver electrical stimulation therapy (Gunderson Col. 4, lines 19-20) and to calculate resistance (Gunderson Col. 9, line 63 and Col. 10, line 4).
Regarding claim 11, Prutchi in combination with An, Man, and Gunderson teaches all limitations of claim 10 as described in the rejection above.
Prutchi teaches that the control circuit is configured to: recurrently initiate an impedance measurement (¶[0073], where “assessment of the lead condition via impedance measurements is performed periodically and/or at pre-set timing and/or at pre-set intervals, for example every 5 minutes, every 50 minutes, every 30 minutes, every hour, every 4 hours, every 12 hours, every 24 hours, every 2 days, every week, or intermediate, longer or shorter time intervals”) between the housing and lead electrode of an implantable lead that includes the pacing electrode as a lead tip electrode (¶[0014], where “the defibrillation lead comprises a … tip electrode,” ¶[0025], where “the invention there is provided a method of testing lead integrity in an implantable cardiac device comprising at least one lead including at least two electrodes … measuring impedance between the at least two electrodes and/or between an electrode and the device housing; and determining a condition of the lead according to the measured impedance value”); and
produce an alert regarding placement of the implantable lead (¶[0121], where “The leads of an active implanted cardiac device are, in some cases, most prone to failure, for example as compared to other components of the device. Lead failures or defects, such as a cut-off in the lead wire or a hole in the lead insulation sheath may form due to tension on the lead, body movements, blood flow in contact with the lead, and/or other ... for maintaining a safe and functioning system it is desired to provide for quick and efficient detection of a lead condition (e.g. fracture, dislodgment, connectivity problem, insulation problem, deformation or the like), ¶[0122], where “impedance measurements may allow for detecting the condition of the lead, due to that the measured impedance value is affected by defects (such as mentioned above) and deviates from an expected or normal value or range … the fluctuations in impedance are caused as a result of a change of body posture, movement, breathing and/or heart pulsation, which may move the lead(s) and/or associated circuitry”) in response to the impedance measured for the pacing electrode being greater than the one or more specified impedance values by the predetermined threshold impedance value (¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, higher than a set threshold,” ¶[0164], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead,” ¶[0165], ¶[0168]-¶[0169], where “In an example, thresholds are set as follows: … Inappropriately HIGH impedance if Estimated Impedance>100 Ω ... when impedance is found not to be within an expected range, an alert and/or other notification are generated”).
An teaches an impedance measurement between the housing electrode and each lead electrode of an implantable lead that includes the pacing electrode (¶[0026], where “The device 400 can be implantable and the sensing circuit 405 and stimulus circuit 410 can be electrically coupled to electrodes that are implantable, such as the example electrodes of FIG.1. The stimulus circuit 410 can also be used to provide electrical cardiac therapy to the heart of the subject such as electrical pacing therapy,” ¶[0031], where “sensing circuit 405 can be electrically coupled to different electrodes to determine absolute thoracic impedance using different sensing vectors … the sensing vector can include an electrode configured for placement in or near the left ventricle (LV) of the heart (e.g., any of electrodes 160 and 165 placed in a coronary vein lying epicardially on LV) and the housing electrode 111 (LVCan),” ¶[0032], where “the sensing circuit 405 can be electrically connectable to a plurality of sensing vectors useable to generate a plurality of physiological signals representative of thoracic impedance. For instance, the device 400 may include a switching circuit (not shown) to electrically couple different combinations of electrodes to the sensing circuit 405”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of An, which teaches an impedance measurement between the housing electrode and each lead electrode of an implantable lead that includes the pacing electrode, with the modified invention of Prutchi in order to allow the sensing circuit to sense physiological signals in different directions (An ¶[0032]).
Man teaches the left bundle branch pacing electrode (¶[0006], where “Optionally, the target depth locates the first electrode proximate to the left bundle branch (LBB) … the one or more processors are configured to determine that the first electrode is located proximate the LBB when the impedance data decreases from a first data value above a threshold to a second data value below the threshold”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Man, which teaches the left bundle branch pacing electrode, with the modified invention of Prutchi in order to monitor a region of interest within the heart's conductive pathways without penetrating the distal end wall of the corresponding chamber (Man ¶[0034]), where criteria of interest include determination of a maximum impedance measurement (Man ¶[0083]).
Regarding claim 12, Prutchi in combination with An, Man, and Gunderson teaches all limitations of claim 11 as described in the rejection above.
Prutchi teaches that the control circuit is configured to: recurrently initiate an impedance measurement (¶[0073], where “assessment of the lead condition via impedance measurements is performed periodically and/or at pre-set timing and/or at pre-set intervals, for example every 5 minutes, every 50 minutes, every 30 minutes, every hour, every 4 hours, every 12 hours, every 24 hours, every 2 days, every week, or intermediate, longer or shorter time intervals”) between the housing and a ring electrode of the implantable lead configurable for bipolar pacing with the pacing electrode (¶[0014], where “the non-defibrillation electrode comprises a ring electrode,” ¶[0025], where “the invention there is provided a method of testing lead integrity in an implantable cardiac device comprising at least one lead including at least two electrodes … measuring impedance between the at least two electrodes and/or between an electrode and the device housing; and determining a condition of the lead according to the measured impedance value,” ¶[0067], where “the non-defibrillation lead comprises a cardiac contractility modulation lead.” Examiner interprets that a cardiac contractility modulation lead is a type of bipolar pacing lead electrode.); and
produce an alert regarding placement of the implantable lead (¶[0121], where “The leads of an active implanted cardiac device are, in some cases, most prone to failure, for example as compared to other components of the device. Lead failures or defects, such as a cut-off in the lead wire or a hole in the lead insulation sheath may form due to tension on the lead, body movements, blood flow in contact with the lead, and/or other ... for maintaining a safe and functioning system it is desired to provide for quick and efficient detection of a lead condition (e.g. fracture, dislodgment, connectivity problem, insulation problem, deformation or the like), ¶[0122], where “impedance measurements may allow for detecting the condition of the lead, due to that the measured impedance value is affected by defects (such as mentioned above) and deviates from an expected or normal value or range … the fluctuations in impedance are caused as a result of a change of body posture, movement, breathing and/or heart pulsation, which may move the lead(s) and/or associated circuitry”) in response to the impedance measured for at least one of the pacing electrode and the ring electrode being greater than the one or more specified impedance values by the predetermined threshold impedance value (¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, higher than a set threshold,” ¶[0164], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead,” ¶[0165], ¶[0168]-¶[0169], where “In an example, thresholds are set as follows: … Inappropriately HIGH impedance if Estimated Impedance>100 Ω ... when impedance is found not to be within an expected range, an alert and/or other notification are generated”).
An teaches an impedance measurement between the housing electrode and an electrode of the implantable lead configurable for pacing (¶[0026], where “The device 400 can be implantable and the sensing circuit 405 and stimulus circuit 410 can be electrically coupled to electrodes that are implantable, such as the example electrodes of FIG.1. The stimulus circuit 410 can also be used to provide electrical cardiac therapy to the heart of the subject such as electrical pacing therapy,” ¶[0031], where “sensing circuit 405 can be electrically coupled to different electrodes to determine absolute thoracic impedance using different sensing vectors … the sensing vector can include an electrode configured for placement in or near the left ventricle (LV) of the heart (e.g., any of electrodes 160 and 165 placed in a coronary vein lying epicardially on LV) and the housing electrode 111 (LVCan),” ¶[0032], where “the sensing circuit 405 can be electrically connectable to a plurality of sensing vectors useable to generate a plurality of physiological signals representative of thoracic impedance. For instance, the device 400 may include a switching circuit (not shown) to electrically couple different combinations of electrodes to the sensing circuit 405”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of An, which teaches an impedance measurement between the housing electrode and an electrode of the implantable lead configurable for pacing, with the modified invention of Prutchi in order to allow the sensing circuit to sense physiological signals in different directions (An ¶[0032]).
Man teaches the left bundle branch pacing electrode (¶[0006], where “Optionally, the target depth locates the first electrode proximate to the left bundle branch (LBB) … the one or more processors are configured to determine that the first electrode is located proximate the LBB when the impedance data decreases from a first data value above a threshold to a second data value below the threshold”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Man, which teaches the left bundle branch pacing electrode, with the modified invention of Prutchi in order to monitor a region of interest within the heart's conductive pathways without penetrating the distal end wall of the corresponding chamber (Man ¶[0034]), where criteria of interest include determination of a maximum impedance measurement (Man ¶[0083]).
Regarding claim 13, Prutchi in combination with An, Man, and Gunderson teaches all limitations of claim 11 as described in the rejection above. Furthermore, regarding claim 13, see the rejection of claim 11 above which teaches “the calculated impedance between the housing electrode and the left bundle branch pacing electrode”.
Prutchi teaches that the control circuit is configured to produce the alert when the calculated impedance between the housing and the pacing electrode is less than the specified impedance by the predetermined threshold impedance value (¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, … lower than a set threshold,” ¶[0164], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead,” ¶[0165]-¶[0166], where “In an example, thresholds are set as follows: Inappropriately LOW impedance if Estimated Impedance<25 Ω,” ¶[0169], where “when impedance is found not to be within an expected range, an alert and/or other notification are generated”).
Regarding claim 14, Prutchi in combination with An, Man, and Gunderson teaches all limitations of claim 11 as described in the rejection above.
Prutchi teaches that the control circuit is configured to: determine presence of the pacing electrode configured for placement in the left bundle branch (¶[0041], where the device comprises “circuitry for controlling and activating the defibrillation lead and the non-defibrillation lead and for measuring impedance.” Examiner interprets that the circuitry inherently activates when the pacing electrode is attached to the lead and consequently the circuitry as the device could not function to measure electrode impedances if the electrode is not a part of, or present in, the device, where the left bundle branch pacing electrode is taught by Man as stated in the rejection of claim 11.); and
begin recurrently initiating the impedance measurement a specified time duration after determining the pacing electrode is present (¶[0073], where “assessment of the lead condition via impedance measurements is performed periodically and/or at pre-set timing and/or at pre-set intervals, for example every 5 minutes, every 50 minutes, every 30 minutes, every hour, every 4 hours, every 12 hours, every 24 hours, every 2 days, every week, or intermediate, longer or shorter time intervals”).
Regarding claim 16, Prutchi in combination with An, Man, and Gunderson teaches all limitations of claim 10 as described in the rejection above.
Prutchi teaches the calculated impedance differing from the specified impedance by more than the predetermined threshold impedance value (¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, higher than a set threshold,” ¶[0164], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead,” ¶[0165], ¶[0168]-¶[0169], where “In an example, thresholds are set as follows: … Inappropriately HIGH impedance if Estimated Impedance>100 Ω ... when impedance is found not to be within an expected range, an alert and/or other notification are generated”); and
producing the alert in response to the calculated impedance differing from the specified impedance by the predetermined threshold impedance value (¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, higher than a set threshold, lower than a set threshold, not within a desired or predefined range,” ¶[0164] - ¶[0169], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead. In an example, thresholds are set as follows: Inappropriately LOW impedance if Estimated Impedance<25 Ω, Impedance OK if 25Ω≤Estimated Impedance≤100 Ω, Inappropriately HIGH impedance if Estimated Impedance>100 Ω ... when impedance is found not to be within an expected range, an alert and/or other notification are generated”).
Gunderson teaches that the control circuit is configured to: initiate a sensing threshold test in response to the differing calculated impedance (Figure 8, where the cardiac electrical signal is measured subsequent to, or in response to, an abnormal impedance, Col. 3, lines 17-19, where “FIG. 8 is a flow diagram illustrating example operation of an IMD monitoring cardiac electrical signals and lead impedance to identify lead-related problems,” Col. , lines , where “The steps or operations performed in blocks 500, 502, 504, 506, 508, 510, 520, and 522 are the same as described above with respect to FIGS. 4, 5, and 6”); and
producing the alert in response to a detected change in the sensing threshold (Figure 8, where the cardiac electrical signal is measured subsequent to, or in response to, an abnormal impedance and generates an alert if a problem is detected, Col. 18, lines 1-5, where “When control module 60 determines that there is a significant amplitude reduction in the coincident FF cardiac event (“YES” branch of block 508), control module 60 may detect a potential lead-related problem (e.g., short-circuit of conductor of the FF sensing vector) and generate an alert (510)”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Gunderson, which teaches that the control circuit is configured to: initiate a sensing threshold test in response to the differing calculated impedance and producing the alert in response to a detected change in the sensing threshold, with the modified invention of Prutchi in order to alert the patient or a responder that immediate medical attention is required (Gunderson Col. 8, lines 32-33).
Regarding claim 17, Prutchi in combination with An, Man, and Gunderson teaches all limitations of claim 10 as described in the rejection above.
Prutchi teaches that that the control circuit is configured to: initiate a baseline impedance measurement between the housing and the pacing electrode (¶[0042], where the circuitry is configured to “apply a test pulse to measure a baseline impedance between the coil of the defibrillation lead and the housing”); and
use the measured baseline impedance value as the specified impedance value (¶[0045], where the circuitry is configured to “estimate, according to a difference between a currently measured impedance level measured between the at least one electrode of the non-defibrillation lead and the coil of the defibrillation lead and one or both of the baseline impedance measurements, a current impedance between the coil of the defibrillation lead and the housing; and assess a condition of the defibrillation lead based on the estimated current impedance”).
An teaches a housing electrode (¶[0031], where “the sensing vector can include an electrode configured for placement in or near the left ventricle (LV) of the heart (e.g., any of electrodes 160 and 165 placed in a coronary vein lying epicardially on LV) and the housing electrode 111 (LVCan)”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of An, which teaches a housing electrode, with the modified invention of Prutchi in order to allow the sensing circuit to sense physiological signals in different directions by providing another sensing vector (An ¶[0032]).
Man teaches the left bundle branch pacing electrode (¶[0006], where “Optionally, the target depth locates the first electrode proximate to the left bundle branch (LBB) … the one or more processors are configured to determine that the first electrode is located proximate the LBB when the impedance data decreases from a first data value above a threshold to a second data value below the threshold”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Man, which teaches the left bundle branch pacing electrode, with the modified invention of Prutchi in order to monitor a region of interest within the heart's conductive pathways without penetrating the distal end wall of the corresponding chamber (Man ¶[0034]), where criteria of interest include determination of a maximum impedance measurement (Man ¶[0083]).
Regarding claim 18, see the rejection of claim 10 above, which contains substantially similar subject matter to claim 18. However, claim 18 adds “A cardiac rhythm management system, the system comprising: an implantable lead configured for placement in a right ventricle of a subject, the implantable lead having multiple pacing electrodes including a left bundle branch pacing electrode configured for placement in a left bundle branch of the subject; and a medical device for coupling to the implantable lead”.
Prutchi teaches a cardiac rhythm management system (Abstract, where “embodiments relate to a method of testing a lead condition in an implanted cardiac device,” ¶[0048], which teaches implementation of the system, ¶[0074], which teaches “an implantable ICD/cardiac contractility modulation (device comprising a defibrillation lead, a cardiac contractility modulation lead, and circuitry configured for applying a test pulse for measuring impedance between the two leads during applying of the cardiac contractility modulation signal”), the system comprising:
an implantable lead (¶[0025], where “the invention there is provided a method of testing lead integrity in an implantable cardiac device comprising at least one lead including at least two electrodes”) configured for placement in a right ventricle of a subject (¶[0068], where “at least a portion of each of the leads is implanted inside the heart, such as inside the right ventricle,” ¶[0096], where “both leads are shown in right ventricle 131 against ventricular septum 115, however, one or more stimulating leads may be in other locations, with consequently different effect circles and/or targeting different tissues”), the implantable lead having multiple pacing electrodes (¶[0025], where “an implantable cardiac device comprising at least one lead including at least two electrodes”); and
a medical device for coupling to the implantable lead (Figure 3, ¶[0025], where “an implantable cardiac device comprising at least one lead including at least two electrodes,” ¶[0083], where “an example of an ICD (implantable cardioverter defibrillator) device including a defibrillation coil 301 is shown. For assessing the integrity of lead 303 on which the coil is configured, impedance of the coil 301 may be measured by delivering a pulse, from the defibrillation capacitor 305, between coil 301 and the device enclosure 307 (“can”)”).
Man teaches the implantable lead including a left bundle branch pacing electrode configured for placement in a left bundle branch of the subject (¶[0006], where “Optionally, the target depth locates the first electrode proximate to the left bundle branch (LBB) … the one or more processors are configured to determine that the first electrode is located proximate the LBB when the impedance data decreases from a first data value above a threshold to a second data value below the threshold”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Man, which teaches the implantable lead including a left bundle branch pacing electrode configured for placement in a left bundle branch of the subject, with the modified invention of Prutchi in order to monitor a region of interest within the heart's conductive pathways without penetrating the distal end wall of the corresponding chamber (Man ¶[0034]), where criteria of interest include determination of a maximum impedance measurement (Man ¶[0083]).
Regarding claim 19, Prutchi in combination with An, Man, and Gunderson teaches all limitations of claim 18 as described in the rejection above.
Furthermore, regarding claim 19, see the rejection of claim 12 above, which contains substantially similar subject matter to claim 19. However, claim 19 adds “the implantable lead includes a ring electrode configured for pacing a right ventricle of the subject”.
Prutchi teaches that the implantable lead includes a ring electrode configured for pacing a right ventricle of the subject (¶[0014], where “the non-defibrillation electrode comprises a ring electrode,” ¶[0068], where “at least a portion of each of the leads is implanted inside the heart, such as inside the right ventricle,” ¶[0096], where “both leads are shown in right ventricle 131 against ventricular septum 115, however, one or more stimulating leads may be in other locations, with consequently different effect circles and/or targeting different tissues”).
Regarding claim 20, Prutchi in combination with An, Man, and Gunderson teaches all limitations of claim 19 as described in the rejection above.
Furthermore, regarding claim 20, see the rejection of claim 13 above, which contains substantially similar subject matter to claim 20. However, claim 20 adds “the control circuit is configured to produce the alert regarding placement of the implantable lead”.
Prutchi teaches that the control circuit is configured to produce the alert regarding placement of the implantable lead (¶[0121], where “The leads of an active implanted cardiac device are, in some cases, most prone to failure, for example as compared to other components of the device. Lead failures or defects, such as a cut-off in the lead wire or a hole in the lead insulation sheath may form due to tension on the lead, body movements, blood flow in contact with the lead, and/or other ... for maintaining a safe and functioning system it is desired to provide for quick and efficient detection of a lead condition (e.g. fracture, dislodgment, connectivity problem, insulation problem, deformation or the like), ¶[0122], where “impedance measurements may allow for detecting the condition of the lead, due to that the measured impedance value is affected by defects (such as mentioned above) and deviates from an expected or normal value or range … the fluctuations in impedance are caused as a result of a change of body posture, movement, breathing and/or heart pulsation, which may move the lead(s) and/or associated circuitry”).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Prutchi, An, Man, and Gunderson as applied to claim 10 above, and further in view of Sison.
Regarding claim 15, Prutchi in combination with An, Man, and Gunderson teaches all limitations of claim 10 as described in the rejection above.
Prutchi teaches calculated impedance differing from the specified impedance by more than the predetermined threshold impedance value (¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, higher than a set threshold,” ¶[0164], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead,” ¶[0165], ¶[0168]-¶[0169], where “In an example, thresholds are set as follows: … Inappropriately HIGH impedance if Estimated Impedance>100 Ω ... when impedance is found not to be within an expected range, an alert and/or other notification are generated”); and
producing the alert in response to the calculated impedance differing from the specified impedance by the predetermined threshold impedance value (¶[0129], where “a condition of the lead is determined based on the results of the comparison … measured impedance value indicates existence of a defect if it is, for example, higher than a set threshold, lower than a set threshold, not within a desired or predefined range,” ¶[0164] - ¶[0169], where “one or more thresholds are set for determining when the resulting estimated coil-to-can impedance indicates a normal, non-damaged condition of the defibrillation lead; and when the estimated coil-to-can impedance may indicate a defect in the integrity of the defibrillation lead. In an example, thresholds are set as follows: Inappropriately LOW impedance if Estimated Impedance<25 Ω, Impedance OK if 25Ω≤Estimated Impedance≤100 Ω, Inappropriately HIGH impedance if Estimated Impedance>100 Ω ... when impedance is found not to be within an expected range, an alert and/or other notification are generated”).
None of Prutchi, An, Man, nor Gunderson teach that the control circuit is configured to: initiate a capture threshold test in response to the differing calculated impedance nor producing the alert in response to a detected change in the capture threshold.
Sison teaches that the control circuit is configured to: initiate a capture threshold test in response to the differing calculated impedance (¶[0007], where “the one or more processors are further configured to periodically check an operation of the AIMD … periodically checking operation of the AIMD includes determining a lead impedance of the AIMD or determining a pacing capture threshold communicating an alert based on a value of the lead impedance or the pacing capture threshold,” ¶[0037], where “The term “AIMD” shall mean an active implantable medical device … Non-limiting examples of AIMDs include one or more of cardiac implantable electronic devices, neurostimulator devices, implantable leadless monitoring and/or therapy devices, and/or alternative implantable medical devices. For example, the AIMD may represent a cardiac monitoring device, leaded pacemaker, cardioverter, cardiac rhythm management device, defibrillator, neurostimulator, leadless monitoring device, leadless pacemaker, and the like,” ¶[0078], where “at 714 the AIMD conducts periodic auto checks including in one example, the AIMD lead impedance, and pacing capture threshold (PCT).” Examiner interprets that a capture threshold test is in response to the differing calculated impedance since both thresholds are measured, where the measurements include subsequent measuring of the pacing capture threshold. This is because the auto checks are periodic and can pertain to either the lead impedance or pacing capture threshold such that the pacing capture threshold will be subsequent to the lead impedance measurement during said periodic auto checks.); and
producing the alert in response to a detected change in the capture threshold (¶[0007], where “the one or more processors are further configured to periodically check an operation of the AIMD … periodically checking operation of the AIMD includes determining … a pacing capture threshold communicating an alert based on a value of the … pacing capture threshold”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Sison, which teaches that the control circuit is configured to: initiate a capture threshold test in response to the differing calculated impedance and producing the alert in response to a detected change in the capture threshold, with the modified invention of Prutchi in order to periodically check operation of the AIMD (Sison ¶[0007]).
Conclusion
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/SEFRA D. MANOS/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792