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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
Acknowledgement is made of applicant’s amendment which was received by the office on November 13, 2025. Claims 1-3, 5-7, 9-15 are currently pending and are under examination.
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 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 15 is directed to “a method” which describe one of the four statutory categories of patentable subject matter, i.e., a process (Step 1, Yes).
The claim limitations within claim 15 that set forth or describe the abstract idea is/are: “evaluation of atrial events in the atrial electric signal detected by the first detection unit and/or ventricular events in the ventricular electric signal detected by the second detection unit for recognizing a condition of the implantable medical device in which atrial events in the atrial electric signal are detected only insufficiently, wherein the evaluation is carried out on the basis of following criteria: (A): i) stability of the detected atrial events, and ii) absence of atrial events over a first period of time or absence of atrial events during detection of ventricular events at the same time; and (B) at least one of: i) morphology of the detected atrial electric signal, ii) detection of an amplitude of the detected atrial electric signal being lower than a predefined threshold value, iii) comparison of atrial events sensed with a first sensing profile of the first detection unit and atrial events sensed with a second sensing profile of the first detection unit, the second sensing profile being more sensitive than the first sensing profile.” The reasons that the limitations is/are considered an abstract idea is/are the following: The limitations of “evaluation” is a process that under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “by the second detection unit” and “by the first detection unit” nothing in the claim precludes the steps from practically being performed in the mind. For example the “evaluation” language in the context of the claim encompasses the user, with the aid or pen and paper, being provided the detected atrial and/or ventricular electric signal and evaluating the signals using morphology of the detected atrial electric signal, stability of atrial events, absence of atrial events over a first period of time, an amplitude of the detected atrial electric signal being lower than a predefined threshold value, absence of atrial events during detection of ventricular events at the same time and/or comparison of atrial events sensed with a first sensing profile of the first detection unit and atrial events sensed with a second sensing profile of the first detection unit. There is nothing to suggest an undue level of complexity in the steps of evaluation. If a claim limitations, under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls with the “Mental Processes” grouping of abstract ideas. Accordingly the claims recite an abstract idea. Although not drawn to the same subject matter, the claimed limitation(s) is/are similar to the concepts that have been identified as abstract by the courts, such as: collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016), selecting certain information, analyzing it using mathematical techniques, and reporting or displaying the results of the analysis in SAP America Inc. v. Anestric, LLC, 890 F.3d 1016, 126 USPQ2d 1638 (Fed Cir. 2018). Thus, the claim(s) are directed to a judicial exception and fall squarely within the realm of "abstract ideas," which is a patent-ineligible concept (Step 2A: Prong One YES).
Analyzing the claim as whole for an inventive concept, the claims do not include additional elements/steps that integrate the judicial exception into a practical application. Claim 15 does not include additional elements that integrate the mental process into a practical application. The additionally recited element(s) appended to the abstract idea include: “a processor”, “a memory unit, “a first detection unit configured to detect an atrial electric signal of a human or animal heart”, “a second detection unit configured to detect a ventricular electric signal of the same heart” and “a stimulation unit configured to stimulation a cardiac region of the same heart”. The additional elements merely: add insignificant extra-solution activity, reciting “a first detection unit configured to detect an atrial electric signal of a human or animal heart”, and “a second detection unit configured to detect a ventricular electric signal of the same heart” is recited at a high level of generality (i.e. as a general means of gathering ECG signals) and is merely nominally, insignificantly or tangentially related to the performance of the steps, i.e. amounts to mere data gathering, which is a form of insignificant extra-solution activity (pre-solution activity). All uses of the recited judicial exception require the pre-solution activity of data gathering. The additional elements merely: add insignificant extra-solution activity, reciting “a stimulation unit configured to stimulation a cardiac region of the same heart” is recited at a high level of generality (i.e. insignificant application) and is merely nominally, insignificantly or tangentially related to the performance of the steps, i.e. amounts insignificant application, which is a form of insignificant extra-solution activity (post-solution activity), see MPEP 2106.05(g). As discussed above, the additional element of a “processor” and “a memory unit” amount to no more than mere instruction to apply the exception using generic computer components. The “processor” and “a memory unit” are purely general-purpose computer components recited as carrying out the general-purpose computer functions of processing data and displaying to enable the abstract process. As such, this/these recitation(s) is/are nothing more than nominal recitation(s) of a computer covering an abstract concept. See Bancorp Servs. v. Sun Life Assurance Co., 687 F.3d 1266, 103 USPQ2d 1425 (Fed. Circ. 2012). See also Mayo Collaborative Services v. Prometheus Laboratories Inc., 101 USPQé2d 1961 (U.S. 2012), which establishes that a claim cannot simply state the abstract idea and add the words "apply it’, see MPEP 2106.05(f). Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea (Step 2A, Prong Two, NO).
Claim 15 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. e.g., all elements being directed to insignificant extra- solution activity including pre-solution activity carried out using well- understood routine, conventional activities previously known to the industry and amount to elements that have been recognized as well-understood, routine and conventional activity in particular fields e.g. receiving data over a network, Symantec, see MPEP 2106.05(d)(II) or purely general-purpose computer components recited as carrying out the general-purpose computer functions of processing data to enable the abstract process, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Further, utilizing a detecting unit for detecting atrial and/or ventricular electrical signals of heart was well- understood routine and a stimulation unit configured to stimulation a cardiac region of the same heart, are conventional activities previously known to the industry and amount to elements that have been recognized as well-understood, routine and conventional activity in particular fields as evidence by US 2003/0069611 to Levine et al. (leads 20,24 and 30, Fig. 1; a stimulation unit configured to stimulation a cardiac region of the same heart, Figs. 6A-6B). Similarly, when considered as an ordered combination, the additional components/steps of the claim(s) add nothing that is not already present when the steps are considered separately (Step 2B: NO). The claims are not patent eligible.
The instantly rejected claim(s) are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. In the interest of advancing prosecution, the examiner suggests: providing evidence, for example, delineating how the abstract idea and/or additional elements appended to the abstract idea results in an improvement to the technology/technical field, which can show eligibility and/or adding a practical application of the claimed method outside of the computer (e.g. treating a patient). See MPEP § 716.01(c) for examples of providing evidence supported by an appropriate affidavit or declaration. For additional guidance, applicant is directed generally to MPEP § 2106.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 5-7, 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0069611 to Levine et al. (Levine) in view of US Patent No. 8,583,221 to Patel et al. (Patel) (both previously cited) and US 2016/0129262 to Sheldon et al. (Sheldon).
In reference to at least claim 1
Levine discloses an implantable medical device (e.g. stimulation device 10), comprising a processor (e.g. micro-controller 60), a memory unit (e.g. memory 94) , a first detection unit (e.g. right atrial lead 20 that includes electrodes 22 and 23 is the “first detection unit”) configured to detect an atrial electric signal of a human or animal heart (e.g. atrial sensing, para. [0043]), and a second detection unit (e.g. right ventricular lead 30 that includes electrodes 32 and 34 is the “second detection unit”) configured to detect a ventricular electric signal of the same heart (e.g. ventricular sensing, para. [0043]), in the memory unit comprises a computer-readable program that causes the processor to perform the following step when executed on the processor (e.g. program code stored in memory, para. [0039]): evaluation of atrial events in the atrial electric signal detected by the first detection unit and/or ventricular events in the ventricular electric signal detected by the second detection unit for recognizing a condition of the implantable medical device (e.g. loss of capture, para. [0019]) in which atrial events in the atrial electric signal are detected only insufficiently (e.g. atrial under sensing determination, Figs. 4 and 6B) wherein the evaluation is carried out on the basis of at least one of the following criteria: A) i) stability of the detected atrial events (e.g. 635, Fig. 6B, para. [0100]) and ii) absence of atrial events over a first period of time (e.g. ventricular sensing of R-wave without atrial sensing of a preceding P-wave, claim 13) determine that atrial events in the atrial electric signal are detected only insufficiently when there is a lack of stability, when there is an absence of atrial events over the first time period or an absence of atrial events during detection of ventricular events at the same time (e.g. looking at stability of the atrial events 635, Fig. 6B, para. [0100]); switching when it is determined that atrial events in the atrial electric signals are detected only insufficiently, the implantable medical device from a multi-chamber detection logic to a one-chamber detection logic (e.g. automatic mode switching including from a multi-chamber detection logic to a single-chamber detection logic, Figs. 6A-6B).
Levine does not explicitly disclose using (B) at least one of: i) morphology of the detected atrial electric signal ii) detection of an amplitude of the detected atrial electric signal being lower than a predefined threshold value, iii) comparison of atrial events sensed with a first sensing profile of the first detection unit and atrial events sensed with a second sensing profile of the first detection unit, the second sensing profile being more sensitive than the first sensing profile and the switching including based on the evaluation when it is determined that atrial events in the atrial electric signal are detected only insufficiently the implantable medical device from a multi-chamber detection logic, which uses both the atrial electric signal and the ventricular electric signal, to a one-chamber detection logic, which uses only the ventricular electric signal.
Patel discloses an implantable medical device (e.g. implantable medical device 10), comprising a processor (e.g. processor 160), a memory unit (e.g. memory 108) , a first detection unit (e.g. lead 20 that includes electrodes 28 and 29) configured to detect an atrial electric signal of a human or animal heart (e.g. cardiac electrical signals from a particular chamber of the heart, Col. 4, ll. 6-9), and a second detection unit (e.g. lead 20 that includes electrodes 22 and 24) configured to detect a ventricular electric signal of the same heart (e.g. cardiac electrical signals from a particular chamber of the heart, Col. 4, ll. 6-9), in the memory unit comprises a computer-readable program that causes the processor to perform the following step when executed on the processor (e.g. computer-readable instructions…executed by the processor, Col. 3, ll. 24-34): evaluation of atrial events in the atrial electric signal detected by the first detection unit and/or ventricular events in the ventricular electric signal detected by the second detection unit for recognizing a condition of the implantable medical device, in which atrial events in the atrial electric signal are detected only insufficiently (e.g. atrial under sensing, Col. 9, ll. 52-55) wherein the evaluation is carried out on the basis of at least one of the following criteria: i) morphology of the detected atrial electric signal (e.g. ““In some embodiments, a search for possible undersensing may include an EGM signal morphology analysis at block 410. If a P-wave morphology is present during an event interval found to be longer than an undersensing threshold interval, undersensing is detected. In this case, an undersensing threshold interval may be defined as a fixed amount or a percentage greater than a median atrial event interval computed from a number of previous event intervals.”, Col. 9, l. 52 – Col. 10, l. 16), ii) absence of atrial events over a first period of time (e.g. sensed events not present in the recorded episode, Col. 9, ll. 55-62; ventricular events without atrial events, Fig. 6, Col. 11, ll. 16-21). Patel further discloses criteria of under sensing including a minimum number of sensed events based on a total time interval and provides an example of a recorded episode of 10 seconds need a minimum of 9 sensed events (e.g. Col. 9, ll. 55-62) and that correctly identifying over-or-under-sensing can allow correct event identification markers to aid in identifying arrhythmias (e.g. “Corrected event identification markers can include event markers added due to the detection of undersensing and event markers that are removed due to the detection of oversensing.”, Col. 6, ll. 18-21) allowing accurate identification of patterns and rhythms without careful manual analysis of the cardiac signal itself (e.g. Col. 1, ll. 47-55).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Levine to include further using a morphology of the atrial electrical signals to determine undersensing, as taught by Patel, to correctly identify undersensing allowing correct event identification markers and accurate identification of patterns and rhythms without careful manual analysis of the cardiac signal itself (e.g. 221, Col. 1, ll. 47-55).
Regarding, the switching, Sheldon discloses mode switching by a pacing device which discloses switching from an atrio-synchronous ventricular pacing mode to an asynchronous ventricular pacing mode when an atrial undersensing event is detected (e.g. “In some examples, the processing module controls the LPD to switch from the atrio-synchronous ventricular pacing mode to the asynchronous ventricular pacing mode in response to detecting an atrial undersensing event.”, para. [0036], [0041], [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Levine modified by Patel to include based on the atrial undersensing, switching from a multi-chamber detection logic, which uses both the atrial electric signal and the ventricular electric signal, to a one-chamber detection logic, which uses only the ventricular electric signal, as taught by Sheldon, in order to maintain adequate pacing support to the heart.
In reference to at least claim 2
Levine modified by Patel and Sheldon renders obvious a device according to claim 1. Levine further discloses absence of atrial events over a first period of time (e.g. ventricular sensing of R-wave without atrial sensing of a preceding P-wave, claim 13).
Patel discloses an implantable medical device (e.g. implantable medical device 10), comprising a processor (e.g. processor 160), a memory unit (e.g. memory 108) , a first detection unit (e.g. lead 20 that includes electrodes 28 and 29) configured to detect an atrial electric signal of a human or animal heart (e.g. cardiac electrical signals from a particular chamber of the heart, Col. 4, ll. 6-9), and a second detection unit (e.g. lead 20 that includes electrodes 22 and 24) configured to detect a ventricular electric signal of the same heart (e.g. cardiac electrical signals from a particular chamber of the heart, Col. 4, ll. 6-9), in the memory unit comprises a computer-readable program that causes the processor to perform the following step when executed on the processor (e.g. computer-readable instructions…executed by the processor, Col. 3, ll. 24-34): evaluation of atrial events in the atrial electric signal detected by the first detection unit and/or ventricular events in the ventricular electric signal detected by the second detection unit for recognizing a condition of the implantable medical device, in which atrial events in the atrial electric signal are detected only insufficiently (e.g. atrial under sensing, Col. 9, ll. 52-55) wherein the evaluation is carried out on the basis of at least one of the following criteria: i) morphology of the detected atrial electric signal (e.g. signal morphology analysis, Col. 9, l. 52 – Col. 10, l. 16), ii) lacking stability of atrial events, iii) absence of atrial events over a first period of time (e.g. sensed events not present in the recorded episode, Col. 9, ll. 55-62; ventricular events without atrial events, Fig. 6, Col. 11, ll. 16-21). Patel further discloses criteria of under sensing including a minimum number of sensed events based on a total time interval and provides an example of a recorded episode of 10 seconds need a minimum of 9 sensed events (e.g. Col. 9, ll. 55-62).
Since Levine discloses absence of atrial events over a first period of time, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Levine to include a minimum number of sensed events based on a total time interval, as taught by Patel, in order to provide accurate event rate and patterns (e.g. ‘221, Col. 1, ll. 53-55). Further, it would have been well within the level of ordinary skill in the art to select a total time interval as 5 seconds and determining the number of events that must be present within that 5 second interval. Additionally, it would have been an obvious matter of design choice to further modify Levine modified by Patel, to have the first period of time being a time between 1 and 5 seconds, since applicant has not disclosed that having the first period of time being a time between 1 and 5 seconds solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality that the first period of time is a time between 1 and 5 seconds, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04.
In reference to at least claim 3
Levine modified by Patel and Sheldon renders obvious a device according to claim 1. However, Levine does not explicitly teach wherein at least one criterion in evaluation step (A) comprises an absence of atrial events over a period of time in which 2 to 5 ventricular events are detected.
Patel discloses an implantable medical device (e.g. implantable medical device 10), comprising a processor (e.g. processor 160), a memory unit (e.g. memory 108) , a first detection unit (e.g. lead 20 that includes electrodes 28 and 29) configured to detect an atrial electric signal of a human or animal heart (e.g. cardiac electrical signals from a particular chamber of the heart, Col. 4, ll. 6-9), and a second detection unit (e.g. lead 20 that includes electrodes 22 and 24) configured to detect a ventricular electric signal of the same heart (e.g. cardiac electrical signals from a particular chamber of the heart, Col. 4, ll. 6-9), in the memory unit comprises a computer-readable program that causes the processor to perform the following step when executed on the processor (e.g. computer-readable instructions…executed by the processor, Col. 3, ll. 24-34): evaluation of atrial events in the atrial electric signal detected by the first detection unit and/or ventricular events in the ventricular electric signal detected by the second detection unit for recognizing a condition of the implantable medical device, in which atrial events in the atrial electric signal are detected only insufficiently (e.g. atrial under sensing, Col. 9, ll. 52-55) wherein the evaluation is carried out on the basis of at least one of the following criteria: I) morphology of the detected atrial electric signal (e.g. signal morphology analysis, Col. 9, l. 52 – Col. 10, l. 16), ii) lacking stability of atrial events, iii) absence of atrial events over a first period of time (e.g. sensed events not present in the recorded episode, Col. 9, ll. 55-62; ventricular events without atrial events, Fig. 6, Col. 11, ll. 16-21). Patel further discloses at least one criterion comprises an absence of atrial events over a period of time in which 2 to 5 ventricular events are detected (e.g. under sensing detected at 510 and 512 after 2 ventricular events without an atrial sense, Fig. 6, Col. 11, ll. 16-21).
Since Levine discloses using an absence of atrial events to determine atrial under sensing, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Levine to include detecting an absence of atrial events over a period of time in which 2 to 5 ventricular events are detected, as taught by Patel, in order to provide accurate event rate and patterns to improve the ability to efficiently and accurately identify patterns and rhythms (e.g. ‘221, Col. 1, ll. 53-55).
In reference to at least claim 5
Levine modified by Patel and Sheldon renders obvious a device according to claim 1. Levine further discloses wherein the evaluation in evaluation step (B) is carried out on the basis of the following criteria: I) no detected atrial event while at least 3 ventricular events are detected and lacking stability of atrial events, or ii) no detected P wave during the first period of time (e.g. ventricular sensing of an R-wave without atrial sensing of a preceding P-wave during the time period, para. [0071], claim 13).
In reference to at least claim 6
Levine modified by Patel and Sheldon renders obvious a device according to claim 1. Levine further discloses absence of atrial events over a first period of time (e.g. ventricular sensing of R-wave without atrial sensing of a preceding P-wave, claim 13).
Patel discloses evaluation of atrial events in the atrial electric signal detected by the first detection unit and/or ventricular events in the ventricular electric signal detected by the second detection unit for recognizing a condition of the implantable medical device, in which atrial events in the atrial electric signal are detected only insufficiently (e.g. atrial under sensing, Col. 9, ll. 52-55) wherein the evaluation is carried out on the basis of at least one of the following criteria: i) morphology of the detected atrial electric signal (e.g. signal morphology analysis, Col. 9, l. 52 – Col. 10, l. 16), ii) lacking stability of atrial events, iii) absence of atrial events over a first period of time (e.g. sensed events not present in the recorded episode, Col. 9, ll. 55-62; ventricular events without atrial events, Fig. 6, Col. 11, ll. 16-21). Patel further discloses criteria in which no atrial events are detected while at least 2 ventricular events are detected (e.g. under sensing detected at 510 and 512 after 2 ventricular events without an atrial sense, Fig. 6, Col. 11, ll. 16-21).
Since Levine discloses absence of atrial events over a first period of time, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Levine to include no atrial events are detected while at least 2 ventricular events are detected, as taught by Patel, in order to provide accurate event rate and patterns (e.g. ‘221, Col. 1, ll. 53-55). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that if 2 sensed ventricular events without a sensed atrial event indicate atrial under sensing then a larger number of sensed ventricular events such as at least 3 ventricular events without a sensed atrial event would also indicate atrial under sensing. Additionally, it would have been an obvious matter of design choice to modify the Patel reference, to have the evaluation carried out based on no detected atrial event while at least 3 ventricular events are detected, since applicant has not disclosed that having the evaluation carried out based on no detected atrial event while at least 3 ventricular events are detected solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality that the evaluation be carried out based on no detected atrial event while at least 3 ventricular events are detected, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04.
In reference to at least claim 7
Levine modified by Patel and Sheldon renders obvious a device according to claim 1. Levine further discloses the evaluation being based on absence of atrial events over a first period of time (e.g. ventricular sensing of R-wave without atrial sensing of a preceding P-wave, claim 13). However, Levine does not explicitly teach sending a signal to a home monitoring service center that serves for monitoring a health status of a patient carrying the implantable device.
Patel further discloses the processor sending a signal to a home monitoring service center that serves for monitoring a health status of a patient carrying the implantable device (e.g. transmitted to external device..external device may be a computer, home monitor, or hand-held device, Col. 3, ll. 9-17).
Since Levine discloses using an implantable medical device, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Levine to include sending a signal to a home monitoring service center that serves for monitoring a health status of a patient carrying the implantable device, as taught by Patel, in order to provide remote patient monitoring and device programming enabling a clinician to review the EGM signal data (e.g. ‘221, Col. 5, ll. 44-51).
In reference to at least claim 9
Levine modified by Patel and Sheldon renders obvious a device according to claim 1. Levine further discloses the processor to perform the following step when executed on the processor: automatically adjusting at least one detection parameter of the first detection unit (e.g. adjusting atrial sensitivity 632, para. [0100]).
In reference to at least claim 10
Levine modified by Patel and Sheldon renders obvious a device according to claim 1. Levine further discloses the processor to perform the following step when executed on the processor: automatically switching from a first sensing profile of the first detection unit to a second sensing profile of the first detection unit, the second sensing profile being more sensitive than the first sensing profile (e.g. increase atrial sensitivity 632, para. [0100]).
In reference to at least claim 11
Levine modified by Patel and Sheldon renders obvious a device according to claim 1. Levine further discloses the evaluation being based on absence of atrial events over a first period of time (e.g. ventricular sensing of R-wave without atrial sensing of a preceding P-wave, claim 13). However, Levine does not explicitly teach electronically adding an atrial event to the detected atrial electric signals if a P wave is extracted in course of a morphological evaluation of a far-field potential detected by the first detection unit.
Patel discloses evaluation of atrial events in the atrial electric signal detected by the first detection unit and/or ventricular events in the ventricular electric signal detected by the second detection unit for recognizing a condition of the implantable medical device, in which atrial events in the atrial electric signal are detected only insufficiently (e.g. atrial under sensing, Col. 9, ll. 52-55) wherein the evaluation is carried out on the basis of at least one of the following criteria: I) morphology of the detected atrial electric signal (e.g. signal morphology analysis, Col. 9, l. 52 – Col. 10, l. 16), ii) lacking stability of atrial events, iii) absence of atrial events over a first period of time (e.g. sensed events not present in the recorded episode, Col. 9, ll. 55-62; ventricular events without atrial events, Fig. 6, Col. 11, ll. 16-21). Patel further discloses electronically adding an atrial event to the detected atrial electric signals if a P wave is extracted in course of a morphological evaluation of a far-field potential detected by the first detection unit (e.g. Col. 5, ll. 52-55, Col. 10, ll. 24-41).
Since Levine discloses using an absence of atrial events to determine atrial under sensing, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Levine to include electronically adding an atrial event to the detected atrial electric signals if a P wave is extracted in course of a morphological evaluation of a far-field potential detected by the first detection unit, as taught by Patel, in order to provide accurate event rate and patterns to improve the ability to efficiently and accurately identify patterns and rhythms (e.g. ‘221, Col. 1, ll. 53-55).
In reference to at least claim 12
Levine modified by Patel and Sheldon renders obvious a device according to claim 1. Levine further discloses the processor to perform the following step when executed on the processor: automatically switching back from an operational mode adopted by the implantable medical device after having recognized an insufficient detection of atrial electric signal to a regular operational mode if a tachycardic rhythm has been terminated or if no insufficient detection of atrial electric signals has been recognized over a second period of time (e.g. mode from blanking period under sensing mode 420 back to a normal operating mode 300, Fig. 3, para. [0081], [0090]).
In reference to at least claim 13
Levine modified by Patel and Sheldon render obvious an implantable medical device according to claim 1 (see rejection of claim 1 above). Levine further discloses in which a condition in an atrial electric signals are detected only insufficiently (e.g. atrial under sensing, abstract, Figs. 4 and 6B), the method comprising the following steps: evaluating atrial events in the atrial electric signal detected by the first detection unit (e.g. atrial sensing, para. [0043]), and/or ventricular events in the ventricular electric signal detected by the second detection unit (e.g. ventricular sensing, para. [0043]), for recognizing a condition of the implantable medical device (e.g. loss of capture, para. [0019]) in which atrial events in the atrial electric signal are detected only insufficiently (e.g. atrial under sensing determination, Figs. 4 and 6B), wherein the evaluation is carried out on the basis of at least one of the following criteria: A) i) stability of the detected atrial events (e.g. 635, Fig. 6B, para. [0100]) and ii) absence of atrial events over a first period of time (e.g. ventricular sensing of R-wave without atrial sensing of a preceding P-wave, claim 13) determine that atrial events in the atrial electric signal are detected only insufficiently when there is a lack of stability, when there is an absence of atrial events over the first time period or an absence of atrial events during detection of ventricular events at the same time (e.g. looking at stability of the atrial events 635, Fig. 6B, para. [0100]); switching when it is determined that atrial events in the atrial electric signals are detected only insufficiently, the implantable medical device from a multi-chamber detection logic to a one-chamber detection logic (e.g. automatic mode switching including from a multi-chamber detection logic to a single-chamber detection logic, Figs. 6A-6B).
Levine does not explicitly disclose using (B) at least one of: i) morphology of the detected atrial electric signal ii) detection of an amplitude of the detected atrial electric signal being lower than a predefined threshold value, iii) comparison of atrial events sensed with a first sensing profile of the first detection unit and atrial events sensed with a second sensing profile of the first detection unit, the second sensing profile being more sensitive than the first sensing profile and the switching including based on the evaluation when it is determined that atrial events in the atrial electric signal are detected only insufficiently the implantable medical device from a multi-chamber detection logic, which uses both the atrial electric signal and the ventricular electric signal, to a one-chamber detection logic, which uses only the ventricular electric signal.
Patel discloses an implantable medical device (e.g. implantable medical device 10), comprising a processor (e.g. processor 160), a memory unit (e.g. memory 108) , a first detection unit (e.g. lead 20 that includes electrodes 28 and 29) configured to detect an atrial electric signal of a human or animal heart (e.g. cardiac electrical signals from a particular chamber of the heart, Col. 4, ll. 6-9), and a second detection unit (e.g. lead 20 that includes electrodes 22 and 24) configured to detect a ventricular electric signal of the same heart (e.g. cardiac electrical signals from a particular chamber of the heart, Col. 4, ll. 6-9), in the memory unit comprises a computer-readable program that causes the processor to perform the following step when executed on the processor (e.g. computer-readable instructions…executed by the processor, Col. 3, ll. 24-34): evaluation of atrial events in the atrial electric signal detected by the first detection unit and/or ventricular events in the ventricular electric signal detected by the second detection unit for recognizing a condition of the implantable medical device, in which atrial events in the atrial electric signal are detected only insufficiently (e.g. atrial under sensing, Col. 9, ll. 52-55) wherein the evaluation is carried out on the basis of at least one of the following criteria: i) morphology of the detected atrial electric signal (e.g. ““In some embodiments, a search for possible undersensing may include an EGM signal morphology analysis at block 410. If a P-wave morphology is present during an event interval found to be longer than an undersensing threshold interval, undersensing is detected. In this case, an undersensing threshold interval may be defined as a fixed amount or a percentage greater than a median atrial event interval computed from a number of previous event intervals.”, Col. 9, l. 52 – Col. 10, l. 16), ii) absence of atrial events over a first period of time (e.g. sensed events not present in the recorded episode, Col. 9, ll. 55-62; ventricular events without atrial events, Fig. 6, Col. 11, ll. 16-21). Patel further discloses criteria of under sensing including a minimum number of sensed events based on a total time interval and provides an example of a recorded episode of 10 seconds need a minimum of 9 sensed events (e.g. Col. 9, ll. 55-62) and that correctly identifying over-or-under-sensing can allow correct event identification markers to aid in identifying arrhythmias (e.g. “Corrected event identification markers can include event markers added due to the detection of undersensing and event markers that are removed due to the detection of oversensing.”, Col. 6, ll. 18-21) allowing accurate identification of patterns and rhythms without careful manual analysis of the cardiac signal itself (e.g. Col. 1, ll. 47-55).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Levine to include further using a morphology of the atrial electrical signals to determine undersensing, as taught by Patel, to correctly identify undersensing allowing correct event identification markers and accurate identification of patterns and rhythms without careful manual analysis of the cardiac signal itself (e.g. 221, Col. 1, ll. 47-55).
Regarding, the switching, Sheldon discloses mode switching by a pacing device which discloses switching from an atrio-synchronous ventricular pacing mode to an asynchronous ventricular pacing mode when an atrial undersensing event is detected (e.g. “In some examples, the processing module controls the LPD to switch from the atrio-synchronous ventricular pacing mode to the asynchronous ventricular pacing mode in response to detecting an atrial undersensing event.”, para. [0036], [0041], [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Levine modified by Patel to include based on the atrial undersensing, switching from a multi-chamber detection logic, which uses both the atrial electric signal and the ventricular electric signal, to a one-chamber detection logic, which uses only the ventricular electric signal, as taught by Sheldon, in order to maintain adequate pacing support to the heart.
In reference to at least claim 14
Levine discloses a computer program product comprising computer-readable code that causes the processor to perform the following step when executed on the processor (e.g. program code stored in memory, para. [0039]): evaluation of atrial events in the atrial electric signal detected by a first detection unit (e.g. atrial sensing, para. [0043]), and/or ventricular events in the ventricular electric signal detected by a second detection unit (e.g. atrial sensing, para. [0043]), for recognizing a condition of the implantable medical device (e.g. loss of capture, para. [0019]) in which atrial events in the atrial electric signal are detected only insufficiently (e.g. atrial under sensing determination, Figs. 4 and 6B), wherein the evaluation is carried out on the basis of at least one of the following criteria: A) i) stability of the detected atrial events (e.g. 635, Fig. 6B, para. [0100]) and ii) absence of atrial events over a first period of time (e.g. ventricular sensing of R-wave without atrial sensing of a preceding P-wave, claim 13) determine that atrial events in the atrial electric signal are detected only insufficiently when there is a lack of stability, when there is an absence of atrial events over the first time period or an absence of atrial events during detection of ventricular events at the same time (e.g. looking at stability of the atrial events 635, Fig. 6B, para. [0100]); switching when it is determined that atrial events in the atrial electric signals are detected only insufficiently, the implantable medical device from a multi-chamber detection logic to a one-chamber detection logic (e.g. automatic mode switching including from a multi-chamber detection logic to a single-chamber detection logic, Figs. 6A-6B).
Levine does not explicitly disclose using (B) at least one of: i) morphology of the detected atrial electric signal ii) detection of an amplitude of the detected atrial electric signal being lower than a predefined threshold value, iii) comparison of atrial events sensed with a first sensing profile of the first detection unit and atrial events sensed with a second sensing profile of the first detection unit, the second sensing profile being more sensitive than the first sensing profile and the switching including based on the evaluation when it is determined that atrial events in the atrial electric signal are detected only insufficiently the implantable medical device from a multi-chamber detection logic, which uses both the atrial electric signal and the ventricular electric signal, to a one-chamber detection logic, which uses only the ventricular electric signal.
Patel discloses an implantable medical device (e.g. implantable medical device 10), comprising a processor (e.g. processor 160), a memory unit (e.g. memory 108) , a first detection unit (e.g. lead 20 that includes electrodes 28 and 29) configured to detect an atrial electric signal of a human or animal heart (e.g. cardiac electrical signals from a particular chamber of the heart, Col. 4, ll. 6-9), and a second detection unit (e.g. lead 20 that includes electrodes 22 and 24) configured to detect a ventricular electric signal of the same heart (e.g. cardiac electrical signals from a particular chamber of the heart, Col. 4, ll. 6-9), in the memory unit comprises a computer-readable program that causes the processor to perform the following step when executed on the processor (e.g. computer-readable instructions…executed by the processor, Col. 3, ll. 24-34): evaluation of atrial events in the atrial electric signal detected by the first detection unit and/or ventricular events in the ventricular electric signal detected by the second detection unit for recognizing a condition of the implantable medical device, in which atrial events in the atrial electric signal are detected only insufficiently (e.g. atrial under sensing, Col. 9, ll. 52-55) wherein the evaluation is carried out on the basis of at least one of the following criteria: i) morphology of the detected atrial electric signal (e.g. ““In some embodiments, a search for possible undersensing may include an EGM signal morphology analysis at block 410. If a P-wave morphology is present during an event interval found to be longer than an undersensing threshold interval, undersensing is detected. In this case, an undersensing threshold interval may be defined as a fixed amount or a percentage greater than a median atrial event interval computed from a number of previous event intervals.”, Col. 9, l. 52 – Col. 10, l. 16), ii) absence of atrial events over a first period of time (e.g. sensed events not present in the recorded episode, Col. 9, ll. 55-62; ventricular events without atrial events, Fig. 6, Col. 11, ll. 16-21). Patel further discloses criteria of under sensing including a minimum number of sensed events based on a total time interval and provides an example of a recorded episode of 10 seconds need a minimum of 9 sensed events (e.g. Col. 9, ll. 55-62) and that correctly identifying over-or-under-sensing can allow correct event identification markers to aid in identifying arrhythmias (e.g. “Corrected event identification markers can include event markers added due to the detection of undersensing and event markers that are removed due to the detection of oversensing.”, Col. 6, ll. 18-21) allowing accurate identification of patterns and rhythms without careful manual analysis of the cardiac signal itself (e.g. Col. 1, ll. 47-55).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Levine to include further using a morphology of the atrial electrical signals to determine undersensing, as taught by Patel, to correctly identify undersensing allowing correct event identification markers and accurate identification of patterns and rhythms without careful manual analysis of the cardiac signal itself (e.g. 221, Col. 1, ll. 47-55).
Regarding, the switching, Sheldon discloses mode switching by a pacing device which discloses switching from an atrio-synchronous ventricular pacing mode to an asynchronous ventricular pacing mode when an atrial undersensing event is detected (e.g. “In some examples, the processing module controls the LPD to switch from the atrio-synchronous ventricular pacing mode to the asynchronous ventricular pacing mode in response to detecting an atrial undersensing event.”, para. [0036], [0041], [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Levine modified by Patel to include based on the atrial undersensing, switching from a multi-chamber detection logic, which uses both the atrial electric signal and the ventricular electric signal, to a one-chamber detection logic, which uses only the ventricular electric signal, as taught by Sheldon, in order to maintain adequate pacing support to the heart.
In reference to at least claim 15
Levine discloses a method of treatment of a human or animal patient in need of such treatment by means of an implantable medical device (e.g. treating fast and slow arrhythmias, para. [0035]), wherein the implantable medical device (e.g. stimulation device 10) comprises a processor (e.g. micro-controller 60), a memory unit (e.g. memory 94) , a first detection unit (e.g. right atrial lead 20 that includes electrodes 22 and 23) configured to detect an atrial electric signal of a human or animal heart (e.g. atrial sensing, para. [0043]), and a second detection unit (e.g. right ventricular lead 30 that includes electrodes 32 and 34) configured to detect a ventricular electric signal of the same heart (e.g. ventricular sensing, para. [0043]), and a stimulation unit configured to stimulation a cardiac region of the same heart (e.g. pulse generators 70 and 72 and shocking circuit 116), the method comprising the following steps: evaluation of atrial events in the atrial electric signal detected by the first detection unit and/or ventricular events in the ventricular electric signal detected by the second detection unit for recognizing a condition of the implantable medical device (e.g. loss of capture, para. [0019]) in which atrial events in the atrial electric signal are detected only insufficiently (e.g. atrial under sensing determination, Figs. 4 and 6B) wherein the evaluation is carried out on the basis of the following criteria: A) i) stability of the detected atrial events (e.g. 635, Fig. 6B, para. [0100]) and ii) absence of atrial events over a first period of time (e.g. ventricular sensing of R-wave without atrial sensing of a preceding P-wave, claim 13) determine that atrial events in the atrial electric signal are detected only insufficiently when there is a lack of stability, when there is an absence of atrial events over the first time period or an absence of atrial events during detection of ventricular events at the same time (e.g. looking at stability of the atrial events 635, Fig. 6B, para. [0100]); automatically adjusting a detection mode of the first detection unit if a condition of the implantable medical device has been recognized in which atrial events are only insufficiently detected (e.g. adjusting atrial sensitivity 632, para. [0100]), and stimulating a cardiac region of the human or animal heart by applying a stimulation pulse with the stimulation unit upon an evaluation of a cardiac rhythm of the human or animal heart in the adjusted detection mode (e.g. providing stimulation therapy based on absence or presence of cardiac activity, para. [0045]).
Levine does not explicitly disclose using (B) at least one of: i) morphology of the detected atrial electric signal ii) detection of an amplitude of the detected atrial electric signal being lower than a predefined threshold value, iii) comparison of atrial events sensed with a first sensing profile of the first detection unit and atrial events sensed with a second sensing profile of the first detection unit, the second sensing profile being more sensitive than the first sensing profile and the switching including based on the evaluation when it is determined that atrial events in the atrial electric signal are detected only insufficiently the implantable medical device from a multi-chamber detection logic, which uses both the atrial electric signal and the ventricular electric signal, to a one-chamber detection logic, which uses only the ventricular electric signal.
Patel discloses an implantable medical device (e.g. implantable medical device 10), comprising a processor (e.g. processor 160), a memory unit (e.g. memory 108) , a first detection unit (e.g. lead 20 that includes electrodes 28 and 29) configured to detect an atrial electric signal of a human or animal heart (e.g. cardiac electrical signals from a particular chamber of the heart, Col. 4, ll. 6-9), and a second detection unit (e.g. lead 20 that includes electrodes 22 and 24) configured to detect a ventricular electric signal of the same heart (e.g. cardiac electrical signals from a particular chamber of the heart, Col. 4, ll. 6-9), in the memory unit comprises a computer-readable program that causes the processor to perform the following step when executed on the processor (e.g. computer-readable instructions…executed by the processor, Col. 3, ll. 24-34): evaluation of atrial events in the atrial electric signal detected by the first detection unit and/or ventricular events in the ventricular electric signal detected by the second detection unit for recognizing a condition of the implantable medical device, in which atrial events in the atrial electric signal are detected only insufficiently (e.g. atrial under sensing, Col. 9, ll. 52-55) wherein the evaluation is carried out on the basis of at least one of the following criteria: i) morphology of the detected atrial electric signal (e.g. ““In some embodiments, a search for possible undersensing may include an EGM signal morphology analysis at block 410. If a P-wave morphology is present during an event interval found to be longer than an undersensing threshold interval, undersensing is detected. In this case, an undersensing threshold interval may be defined as a fixed amount or a percentage greater than a median atrial event interval computed from a number of previous event intervals.”, Col. 9, l. 52 – Col. 10, l. 16), ii) absence of atrial events over a first period of time (e.g. sensed events not present in the recorded episode, Col. 9, ll. 55-62; ventricular events without atrial events, Fig. 6, Col. 11, ll. 16-21). Patel further discloses criteria of under sensing including a minimum number of sensed events based on a total time interval and provides an example of a recorded episode of 10 seconds need a minimum of 9 sensed events (e.g. Col. 9, ll. 55-62) and that correctly identifying over-or-under-sensing can allow correct event identification markers to aid in identifying arrhythmias (e.g. “Corrected event identification markers can include event markers added due to the detection of undersensing and event markers that are removed due to the detection of oversensing.”, Col. 6, ll. 18-21) allowing accurate identification of patterns and rhythms without careful manual analysis of the cardiac signal itself (e.g. Col. 1, ll. 47-55).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Levine to include further using a morphology of the atrial electrical signals to determine undersensing, as taught by Patel, to correctly identify undersensing allowing correct event identification markers and accurate identification of patterns and rhythms without careful manual analysis of the cardiac signal itself (e.g. 221, Col. 1, ll. 47-55).
Regarding, the switching, Sheldon discloses mode switching by a pacing device which discloses switching from an atrio-synchronous ventricular pacing mode to an asynchronous ventricular pacing mode when an atrial undersensing event is detected (e.g. “In some examples, the processing module controls the LPD to switch from the atrio-synchronous ventricular pacing mode to the asynchronous ventricular pacing mode in response to detecting an atrial undersensing event.”, para. [0036], [0041], [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Levine modified by Patel to include based on the atrial undersensing, switching from a multi-chamber detection logic, which uses both the atrial electric signal and the ventricular electric signal, to a one-chamber detection logic, which uses only the ventricular electric signal, as taught by Sheldon, in order to maintain adequate pacing support to the heart.
Response to Arguments
Claim Rejections – 35 USC §101 (pgs. 11 of response filed 11/13/2025)
Applicant argues that claim 15 has been amended as suggested by the PTO, however no suggestions have been provided on pg. 16 of the office action mailed 7/15/2025 so it is unclear which suggestions applicant is referring to. As previously stated, claim 15 includes contingent limitations regarding “automatically adjusting” and “stimulation” since the automatically adjusting a detection mode only occurs when a condition of the implanted device has been recognized in which atrial events are only insufficiently detected and the stimulation is provided within the adjusted detection mode, see MPEP 2111.04 (II).
Claim Rejections – 35 USC §102/103 (pgs. 11-16 of response filed 11/13/2025)
Applicant’s arguments, see 11-16, filed 11/13/2025, with respect to the rejection(s) of claim(s) 1,14 and 15 under 35 USC 102 using Levine have been fully considered and are persuasive in view of the claim amendments. Therefore, the rejection of claim(s) 1,14 and 15 under 35 USC 102 using Levine has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Patel and Sheldon, see 103 rejection above. Applicant states that the limitations are also not taught by Patel, see pg. 15 of response filed 11/13/2025, but those arguments amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the Patel reference.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JG/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796