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 .
Status of Claims
Claims 1-13 and 21-27 are currently pending and under consideration.
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 1-13, 21-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract idea of “determining a ventricular activation time, determining a difference between the ventricular activation time and a previously determined ventricular activation time, and determining when the difference meets a threshold difference” without significantly more.
Step 1
Claims recite a device, and therefore, it is a product and falls within the statutory category.
Step 2A, Prong 1
Claims 1 and 21 recite a limitation of determining a ventricular activation time, determining a difference between the ventricular activation time and a previously determined ventricular activation time, and determining when the difference meets a threshold difference by using a processor. The ventricular activation time determination limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of the generic processor. That is, other than reciting the processor, nothing in the claims precludes the ventricular activation time determination step from practically being performed in the human mind. For example, but for the processor language, the claims encompasses the user visually inspecting electrocardiographic waveforms to identify the ventricular activation time. This limitation is a mental process.
Step 2A, Prong 2
The claims recite additional elements: “a processor”, “obtaining one or more electrocardiogram (ECG) signals”, “a plurality of pacing pulses”, “a display unit” used to “display at least one of the one or more ECG signals”, “display at least one of the determined ventricular activation times or the determined differences” and “display a conspicuous indicator”.
The “processor” is recited at a high level of generality (i.e., a generic computer processor) and amounts to no more than pre-solution activity of data gathering by the medical device.
The “obtaining one or more electrocardiogram (ECG) signals” is recited at a high level of generality (i.e., any processor with the ability to perform data gathering) and adds insignificant extra-solution activity to the judicial exception.
The “a plurality of pacing pulses” is recited at a high level of generality (i.e., any stimulating pulse), which constitutes as extra-solution activity, and does not integrate the judicial exception into a practical application. The pacing pulses are applied as a necessary precursor to the mental analysis steps and therefore only amount to insignificant, extra-solution activity. See § MPEP 2106.04(d)(2) Example C for further information.
The “display”, which reads on a generic computer component, is recited at a high level of generality, i.e., as a generic display, performing a generic function of displaying physiological information determined from the electrocardiogram signals. This generic display limitation is no more than mere instructions to apply the exception using a generic computer component.
The steps of “displaying at least one of the one or more ECG signals”, “displaying at least one of the determined ventricular activation times or the determined differences” and “displaying a conspicuous indicator” are recited at a high level of generality, (i.e., a generic display displaying physiological data taken from the ECG signals), and it amounts to no more than post-solution activity of displaying data.
All of the additional elements mentioned above do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B
As discussed with respect to Step 2A Prong Two, the additional elements in the claims amount to no more than mere instructions to apply an exception on generic computer and output components, adding insignificant extra-solution activity to the judicial exception, and mere extra-solution activity. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on generic computer and output components, adding insignificant extra-solution activity to the judicial exception, and mere extra-solution activity cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept without significantly more in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification in paragraph [0039] does not provide any indication that the computer processor is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claims as a whole amount to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
As discussed with respect to Step 2A Prong Two, the “processor” is recited at a high level of generality (i.e., any processor able to gather and process ECG data) and it amounts to no more than pre-solution activity of data gathering by the medical device to determine the ventricular activation times.
The obtaining one or more electrocardiogram (ECG) signals and plurality of pacing pulses are recited at a high level of generality and it amounts to no more than mere pre-solution activity of data gathering and extra-solution activity. These pre-solution activities of data gathering and stimulation using a medical device with a processor is well-understood, routine, and conventional in the field of electrocardiology. All uses of the recited abstract idea require the pre-solution of data gathering and stimulation without significantly more.
The “display unit”, which reads on a generic computer component, and subsequent display steps, are recited at a high level of generality, i.e., as a generic display, displaying physiological data, and it amounts to no more than post-solution activity of providing an alert without significantly more.
Dependent claims 2-13, and 21-27 further limit the process of determining a ventricular activation time, determining a difference between the ventricular activation time and a previously determined ventricular activation time, and determining when the difference meets a threshold difference.
Dependent claims 2, 8-10 and 22 further limit the process of determining ventricular activation data to another field of use.
Dependent claims 3 and 23 further limit the process of determining ventricular activation data through generic data gathering.
Dependent claims 4, 7, 24, and 27 further limit the process of determining ventricular activation data through generic data gathering and insignificant extra solution activity.
Dependent claims 5-6, 11, and 25-26 further limit the process of determining ventricular activation data through generic data display and insignificant extra solution activity.
Dependent claim 12 further limits the process of determining ventricular activation data because although pacing is claimed, it is not based on the determined results and instead based on the previous analysis steps. The pacing pulses are applied only as a precursor to the data gathering and mental analysis steps. See § MPEP 2106.04(d)(2) Example C for further information.
Dependent claim 13 further limits the process of determining ventricular activation data through data gathering and generic computer structure of telemetry circuit.
Therefore, these claims further limit the abstract idea already indicated in independent claims 1 and 21 and they are ineligible for the same reasons provided for claims 1 and 21 above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 11-13, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ryu et. al, (US 20110137369 A1, published 06/09/2011, hereinafter known as Ryu) in view of Eddy et. al, (US 20180279897 A1, published 10/04/2018, hereinafter known as Eddy).
Regarding claim 1, Ryu discloses a medical device (“exemplary stimulation device”, 100 in Fig. 1 [0025]), comprising:
a processor (“microcontroller typically includes a microprocessor, or equivalent control circuitry” [0038]) configured to:
obtain one or more electrocardiogram (ECG) signals (“exemplary method includes acquiring far-field ventricular signal data (e.g., atrial, surface ECG, etc.)” [0071]):
for each of a plurality of pacing pulses (“atrial pulse generator and a ventricular pulse generator that generate pacing stimulation pulses for delivery” [0040]):
determine a ventricular activation time using a first ECG signal of the one or more ECG signals (“the computing device may determine…ventricular activation times and patterns” [0068]);
determine a difference between the ventricular activation time and a previously determined ventricular activation time (“where each of four electrodes is paced, three differential times can be measured and two additional differential times can be calculated (e.g., as a difference of two times)”, determining the difference between pacing times is directly incorporated into determining the difference between ventricular activation times, [0084]); and
a display unit in communication with the processor (“programmer permits a clinician or other user to program the operation of the implanted device and to retrieve and display information received from the implanted device” [0120]) and configured to:
display at least one of the one or more ECG signals (“external programmer may be configured to receive and display ECG data” [0121]);
display at least one of the determined ventricular activation times or the determined differences (“the clinician may control the external programmer to display any or all of the data retrieved from the implanted device” using broadest reasonable interpretation, all data would include the ventricular activation times and determined differences, [0109], [0137]); and
Ryu does not disclose wherein the medical device can determine when the difference meets a threshold difference and display a conspicuous indicator in response to determining that the threshold difference is met.
However, Eddy teaches methods and systems for use of the Q-wave to R-wave interval (also understood in the art as the ventricular activation time) to guide placement of a leadless cardiac pacemaker. Using the electrodes of the LCP delivery system to capture one or more cardiac cycles while the containment housing is adjacent to the portion of the myocardium to sense a ventricular activation time for the myocardium adjacent the containment housing; capturing a surface electrocardiogram for the patient and identifying a Q-wave for at least one of the one or more cardiac cycles; determining a Q-wave to ventricular activation interval and comparing it to an interval threshold [0009]. A change of more than, for example, 5% to 20%, or 10% in another example, of the Q-wave to R-wave activation interval or AV activation interval may be sufficient to cause an alert to the patient or to a physician via a remote monitoring network [0131].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the determination of whether a difference in ventricular activation times meets a threshold difference and if so, displaying an indicator, of Eddy with the medical device of Ryu because identification of when a ventricular activation time difference exceeds a threshold difference allows for proper adjustment of the stimulation parameters to ensure effective, safe treatment.
Regarding claim 11, Ryu as modified discloses the medical device of claim 1, wherein the display unit is further configured to display the conspicuous indicator by at least one of: generating a visual notification, generating an audible notification, adjusting a format of the determined ventricular activation time to be different than a previously displayed ventricular activation time, and/or adjusting a background of the determined ventricular activation time (“the clinician may control the external programmer to display any or all of the data retrieved from the implanted device…speaker is included for providing audible tones to the user, such as a warning beep” using broadest reasonable interpretation, all data would include the threshold difference [0137] & [0140]).
Regarding claim 12, Ryu as modified discloses the medical device of claim 1, further comprising a pulse generator configured to deliver the plurality of pacing pulses via a conduction system pacing electrode (“atrial pulse generator and a ventricular pulse generator that generate pacing stimulation pulses for delivery by the right atrial lead, the coronary sinus lead, and/or the right ventricular lead via an electrode configuration switch” [0040]).
Regarding claim 21, Ryu discloses non-transitory computer readable medium storing a set of instructions (“instructions to be performed by the CPU are accessed via an internal bus from a read only memory (ROM) and random access memory…additional software may be accessed from a hard drive, floppy drive, and CD ROM drive” [0123]) that, when executed by processing circuitry of a medical device system, cause the medical device system to:
obtain one or more electrocardiogram (ECG) signals (“exemplary method includes acquiring far-field ventricular signal data (e.g., atrial, surface ECG, etc.)” [0071]);
for each of a plurality of pacing pulses (“atrial pulse generator and a ventricular pulse generator that generate pacing stimulation pulses for delivery” [0040]):
determine a ventricular activation time using a first ECG signal of the one or more ECG signals (“the computing device may determine…ventricular activation times and patterns” [0068]);
determine a difference between the ventricular activation time and a previously determined ventricular activation time (“where each of four electrodes is paced, three differential times can be measured and two additional differential times can be calculated (e.g., as a difference of two times)”, determining the difference between pacing times is directly incorporated into determining the difference between ventricular activation times, [0084]);
display at least one of the one or more ECG signals (“external programmer may be configured to receive and display ECG data” [0121]);
display at least one of the determined ventricular activation times or the determined differences (“the clinician may control the external programmer to display any or all of the data retrieved from the implanted device” using broadest reasonable interpretation, all data would include the ventricular activation times and determined differences, [0137]).
Ryu does not disclose wherein the medical device can determine when the difference meets a threshold difference and display a conspicuous indicator in response to determining that the threshold difference is met.
However, Eddy teaches methods and systems for use of the Q-wave to R-wave interval (also understood in the art as the ventricular activation time) to guide placement of a leadless cardiac pacemaker. Using the electrodes of the LCP delivery system to capture one or more cardiac cycles while the containment housing is adjacent to the portion of the myocardium to sense a ventricular activation time for the myocardium adjacent the containment housing; capturing a surface electrocardiogram for the patient and identifying a Q-wave for at least one of the one or more cardiac cycles; determining a Q-wave to ventricular activation interval and comparing it to an interval threshold [0009]. A change of more than, for example, 5% to 20%, or 10% in another example, of the Q-wave to R-wave activation interval or AV activation interval may be sufficient to cause an alert to the patient or to a physician via a remote monitoring network [0131].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the determination of whether a difference in ventricular activation times meets a threshold difference and if so, displaying an indicator, of Eddy with the medical device of Ryu because identification of when a ventricular activation time difference exceeds a threshold difference allows for proper adjustment of the stimulation parameters to ensure effective, safe treatment.
Claims 2 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ryu in view of Eddy (hereinafter known as modified Ryu), and further in view of Ghosh (US 20150032173 A1, published 01/29/2015).
Regarding claims 2 and 22, modified Ryu discloses medical device as described in claim 1, wherein the processor is further configured to obtain the first ECG signal by: receiving four input signals by receiving one input signal (“microcontroller includes the ability to process or monitor input signals” leads 104, 106, 108, and 110 as shown in Fig. 1 would allow for four input signals [0038]) from four electrodes (“a right ventricular tip electrode, a right ventricular ring electrode, a right ventricular (RV) coil electrode, and an SVC coil electrode” [0031]).
Modified Ryu does not disclose receiving input signals from each of a reference electrode and three chest electrodes, the three chest electrodes including a left chest electrode and a right chest electrode; determining a central terminal signal from the four input signals; and determining a first unipolar ECG signal as a difference between the central terminal signal and the one of the four input signals that is received from the left chest electrode.
However, Ghosh teaches a method and system of cardiac pacing including a plurality of activation times determined from a plurality of body-surface electrodes (Abstract). Figure 3B of Ghosh depicts a plurality of chest electrodes, including electrodes placed on the left chest, right chest, and a reference electrode [0057]. A signal acquired or sensed from a single implanted electrode with respect to a distant electrode produces a unipolar electrogram (EGM) waveform while a signal acquired or sensed from a single surface electrode with respect to an indifferent electrode or composite reference like Wilson Central Terminal, produces a unipolar electrocardiogram (ECG) [0057].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to combine the obtaining of ECG signals through a right chest electrode, left chest electrode, and reference electrode and determination of a central terminal signal and unipolar ECG signal of Ghosh with the medical device of modified Ryu because the chest electrodes sit over the heart, this arrangement follows standard 12-lead ECG positioning, and unipolar ECG data may be used to derive a sequence of ventricular activation (Ghosh [0055]).
Claim 3 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over modified Ryu in view of Ghosh (hereinafter known as modified Ryu 2) as applied to claims 2 and 22 above, and further in view of Yarnitsky et. al, (US 20210219904 A1, published 07/22/2021, hereinafter known as Yarnitsky).
Regarding claims 3 and 23, modified Ryu 2 discloses medical device of claim 2.
Modified Ryu 2 does not disclose wherein the processor is further configured to obtain the first ECG signal by:
determining a second unipolar ECG signal from the input signals; and
determining the first ECG signal as a bipolar ECG signal by determining a difference between the first unipolar ECG signal and the second unipolar ECG signal.
However, Yarnitsky teaches a medical system that includes respective electrodes for application to a body of a subject and to output a set of respective activation signals in response to electrical activity of a heart of the subject (Abstract). If the ECG signal is a bipolar signal, it may be assumed to be generated by the difference between a unipolar signal V.sub.unipolar(t).sub.1 on one electrode and a unipolar signal V.sub.unipolar(t).sub.2 on another electrode [0090].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to combine the method of determining a second unipolar ECG signal and determining the first ECG signal as a bipolar ECG signal of Yarnitsky with the medical device of modified Ryu 2 because determining both unipolar and bipolar ECG signals results in a more accurate representation of the entire system of the heart.
Claims 5, 9-10, 13, and 25 is rejected under 35 U.S.C. 103 as being unpatentable over modified Ryu as applied to claim 1 above, and further in view of Ghosh (US 20210106245 A1, published 04/15/2021, hereinafter known as Ghosh 2).
Regarding claims 5 and 25, modified Ryu discloses the medical device of claim 1, wherein the processor and the display unit are further configured to display the plurality of ventricular activation times correspond to at least a portion of the plurality of pacing pulses (“types of information include…ventricular activation times and patterns, which may be based on data acquired as associated with delivery of stimuli to the heart (e.g., pacing stimuli), data acquired as associated with intrinsic activation of the heart or a combination of both paced and intrinsic” [0067]).
Modified Ryu does not disclose wherein the processor and the display unit are further configured to simultaneously display a plurality of cardiac cycles of at least one of the obtained ECG signal(s) and a plurality of the determined ventricular activation times.
However, Ghosh 2 teaches the computing apparatus and the remote computing device may each include display apparatus respectively, that may be configured to display and analyze data such as, e.g., electrical signals (e.g., electrocardiogram data), electrical activation times, electrical heterogeneity information, etc…for example, one cardiac cycle, or one heartbeat, of a plurality of cardiac cycles, or heartbeats…and average left ventricular or thoracic surrogate electrical activation times (LVAT)… [0032].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the display of a plurality of cardiac cycles and ventricular activation times of Ghosh 2 with the medical device of modified Ryu because this can assist a user (e.g., a physician) in the evaluation of cardiac health and/or the configuration (e.g., optimization) of cardiac therapy (Ghosh 2, [0026]).
Regarding claim 9, modified Ryu discloses the medical device of claim 1, wherein: the processor is further configured to:
for at least one of the plurality of pacing pulses, determine a QRS width using the second ECG signal (“an exemplary method includes…monitoring QRS duration/morphology changes from an ECG device”, it is well known in the art that QRS duration is equivalent to QRS width [0073]); and
Modified Ryu does not disclose wherein the processor is configured to:
obtain the one or more ECG signals by receiving a plurality of input signals from at least a right chest electrode, a left chest electrode and a reference electrode, the one or more ECG signals comprising the first ECG signal associated with the left chest electrode and a second ECG signal associated with the right chest electrode; and
the display unit is further configured to display the determined QRS width.
However, Ghosh 2 teaches obtaining electrical signal data from the electrode apparatus which contains a plurality of chest electrodes, including electrodes placed on the left chest, right chest, and a reference electrode, as shown in Figure 3B [0037] & [0058]. Ghosh further teaches a method for improved estimation of time of left ventricular pacing with respect to intrinsic right ventricular activation in cardiac resynchronization therapy, i.e., obtaining ECG signals from both the left and right ventricles, which would be associating with left and right chest electrodes [0057]. The display apparatus may include any apparatus capable of displaying information to a user, such as a graphical user interface including…QRS complexes [0036].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to combine the obtaining of ECG signals through a right chest electrode, left chest electrode, and reference electrode and display of the QRS width of Ghosh 2 with the medical device of modified Ryu because the chest electrodes sit over the heart, and this arrangement follows standard 12-lead ECG positioning.
Regarding claim 10, modified Ryu discloses the medical device of claim 1, wherein:
The processor is further configured to:
determine a peak interval between a maximum peak of the first ECG signal and the second ECG signal (“as to particular techniques to denote a time or times of an activation wavefront, an exemplary method may rely on time of onset of a peak (e.g., deviation from a baseline value), time of maximum peak” [0079]), or a QRS morphology metric (“monitoring QRS duration/morphology changes from an ECG device” [0073]); and the display unit is further configured to display at least one of the QRS area, peak interval or QRS morphology metric (“the clinician may control the external programmer to display any or all of the data retrieved from the implanted device” using broadest reasonable interpretation, all data would include the QRS area, peak interval or QRS morphology metric, [0137]).
Modified Ryu does not disclose the processor is further configured to:
obtain the one or more ECG signals by receiving a plurality of input signals from at least a right chest electrode, a left chest electrode and a reference electrode,
the one or more ECG signals comprising the first ECG signal associated with the left chest electrode and a second ECG signal associated with the right chest electrode.
However, Ghosh teaches a plurality of chest electrodes, including electrodes placed on the left chest, right chest, and a reference electrode, as shown in Figure 3 [0057]. Ghosh further teaches a method for improved estimation of time of left ventricular pacing with respect to intrinsic right ventricular activation in cardiac resynchronization therapy, i.e., obtaining ECG signals from both the left and right ventricles, which would be associating with left and right chest electrodes [0056].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to combine the obtaining of ECG signals through a right chest electrode, left chest electrode, and reference electrode of Ghosh with the medical device of modified Ryu because the chest electrodes sit over the heart, and this arrangement follows standard 12-lead ECG positioning.
Further, modified Ryu does not disclose the processor is further configured to:
for at least one of the plurality of pacing pulses, determine at least one of a QRS area using the second ECG signal.
However, Ghosh 2 teaches systems and methods are described herein for evaluation and configuration cardiac therapy (Abstract). A vectorcardiographic metric may include a three-dimensional QRS area change [0084].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to include the determination of QRS area of Ghosh 2 with modified Ryu because QRS area is a strong predictor of how well a patient is responding to the pacing therapy.
Regarding claim 13, modified Ryu discloses the medical device of claim 1, further comprising a telemetry circuit configured to receive a conduction system pacing pulse signal from an implantable medical device configured to deliver the plurality of pacing pulses as conduction system pacing pulses (“microcontroller may initiate one or more algorithms of the module in response to a signal detected by various circuitry or information received via the telemetry circuit…microcontroller may initiate one or more algorithms of the module in response to a signal detected by various circuitry or information received via the telemetry circuit” [0044]).
Modified Ryu does not disclose a telemetry circuit configured to receive a conduction system pacing pulse marker signal from an implantable medical device.
However, Ghosh 2 teaches telemetry capabilities may include the ability to transmit stored digital information, e.g.,….marker channel pulses indicating the occurrence of sensed and paced depolarizations in the atrium and ventricle [0124].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the use of marker channel pulses of Ghosh 2 with the medical device of modified Ryu because marker channels help indicate the occurrence of sensed and paced depolarizations in the atrium and ventricle, which ultimately aids in the evaluation and analysis of various ECG signals (Ghosh 2, [0124]).
Claims 6-8 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over modified Ryu in view of Donahue (US 20220167907 A1, published 06/02/2022).
Regarding claims 6 and 26, modified Ryu discloses the medical device of claim 1.
Modified Ryu does not disclose wherein the processor and the display unit are further configured to consecutively display each one of a plurality of cardiac cycles of at least one of the obtained ECG signal(s), each one of the plurality of cardiac cycles being displayed individually one at a time with a respective determined ventricular activation time, the plurality of cardiac cycles corresponding to a least a portion of the plurality of pacing pulses.
However, Donahue teaches methods for identifying ventricular tachycardia in subjects (Abstract). Figure 1 depicts one embodiment of ventricular tachycardia (VT) mapping, including example electrograms and a surface electrocardiogram (ECG) strip (top left panel), a graphical display of the activation time during VT for each catheter location (top right panel with markers showing the location of the example electrograms), and entrainment pacing from the site of earliest activation (local electrograms in the middle panel and 12-lead ECG in the bottom panel)…local electrograms are recorded from the pacing electrodes and the closest adjacent bipole…and local capture was confirmed by comparing the timing of the pacing stimulus to the adjacent electrogram [0020].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to combine the display techniques of Donahue with the medical device of modified Ryu because it gives the clinician or practitioner an easily digestible visualization of the data through the displayed cardiac cycles.
Regarding claims 7 and 27, modified Ryu discloses the medical device of claim 1.
Modified Ryu does not disclose wherein:
the processor is further configured to determine each of the ventricular activation times by:
identifying a fiducial point of the first ECG signal following a respective one of the plurality of pacing pulses; and
determining the ventricular activation time as a time interval from the respective one of the plurality of pacing pulses to the fiducial point; and
the display unit is further configured to display, with the determined ventricular activation times, the first ECG signal and a visual marker of at least one of the identified fiducial points of the first ECG signal.
However, Donahue teaches Figure 1 depicts one embodiment of ventricular tachycardia (VT) mapping…mapping process started by moving the catheter throughout the heart during VT, obtaining an electrogram and marking the catheter location at each site, and measuring the timing of each electrogram (top left panel, dashed lines) against a fiduciary point in the surface ECG, which is displayed in the display unit of Fig. 1…local electrograms are recorded from the pacing electrodes and the closest adjacent bipole… and local capture was confirmed by comparing the timing of the pacing stimulus to the adjacent electrogram [0020].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to combine the determination of ventricular activation times of Donahue with the medical device of modified Ryu because an understanding of ventricular activation times can aid in determining whether a patient has any cardiac problems.
Regarding claim 8, modified Ryu discloses medical device of claim 1, wherein:
the display unit is further configured to display each of the ventricular activation times that are determined to be greater than the threshold ventricular activation time and each of the ventricular activation times that are less than the threshold ventricular activation time (“the clinician may control the external programmer to display any or all of the data retrieved from the implanted device” using broadest reasonable interpretation, all data would include the ventricular activation times that are both greater and less than the determined threshold, [0137]).
Modified Ryu does not disclose wherein the processor is further configured to determine when a ventricular activation time of the determined ventricular activation times is greater than a threshold ventricular activation time.
However, Eddy teaches the operational circuitry may be configured to compare the QR interval (also understood in the art as the ventricular activation time) to a threshold for LCP implant acceptability, and, if the threshold is exceeded, to provide an audible or visual indication of acceptability of a position for the LCP [0016].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to include the comparison of ventricular activation times of Eddy with the medical device of modified Ryu because identification of when a ventricular activation time difference exceeds a threshold difference allows for proper adjustment of the stimulation parameters to ensure effective, safe treatment.
Further, modified Ryu does not disclose wherein the display unit is configured to display each of the ventricular activation times that are determined to be greater than the threshold ventricular activation time according to a first format and each of the ventricular activation times that are less than the threshold ventricular activation time according to a second format different than the first format.
However, Donahue teaches multiple formats of presenting data in Figure 1, for example, the middle panel, pacing bottom tracing and closest adjacent top tracing that represents the electrograms recorded from the pacing electrodes [0020].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to include the display formatting of Donahue with the medical device of modified Ryu because this makes it easier for a clinician or practitioner to interpret the data being displayed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/F.M.K./Patent Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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