DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed January 8, 2026 has been entered. Claims 1, 21 have been amended. Claims 4-7, 9, 12-14, 16-17 are canceled. Claims 25-26 are withdrawn. Currently, claims 1-3, 8, 10-11, 15, 18-24 are pending for examination.
Claim 6 is indicated as canceled but presents strike-through claim text. MPEP 714 states, No claim text shall be presented for any claim in the claim listing with the status of “canceled” or “not entered.” For subsequent claim sets, claim 6 should be indicated as “(Cancelled)” with no claim text present (e.g. see claim 7).
Response to Arguments
Applicant’s arguments, see remarks directed to mapping onto a 3D model of the heart (p. 11), filed January 8, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Blake, III (US 2017/0161896).
Applicant's arguments filed January 8, 2026 with respect to Stewart et al. (US 2016/0166310) failing to disclose making any changes to the stimulation signals in response to detection of ectopic events (p. 11) have been fully considered but they are not persuasive. Contrary to the applicant’s argument of the claimed invention “making any changes to the stimulation signal”, claim 1 specifically requires the limitation, “and to stop producing the stimulation signal in response to a count of identified ectopy events increasing to a predetermined number”.
Applicant argues that since Stewart et al. discloses, “the energy generator 22 and/or control unit 14 may have an automated system, selectable by the operator, whereby ectopy, when detected may activate the ablation system to deliver ablative energy upon each detection of, for example, ectopic activity while moving the device on tissue sites and delivering pulsed stimulation to elicit ectopic responses”, the prior art suggests the stimulation continues at the same rate whether or not ectopy is detected and ablation is performed. However, this is not the Office’s interpretation of Stewart.
Paragraph [0022] sets forth the ability of Stewart et al.’s apparatus to, “deliver pulsed stimulation continuously or intermittently from the generator while reserving the ability to switch to ablation energy at any desired moment”. This statement itself suggests that the pulsed stimulation delivery is stopped when ablation energy delivery is desired, since it is “switched to ablation energy”.
The paragraph further continues, “This may give the operator the ability to either perform mapping of part or all of a heart chamber before delivering ablation energy or to perform ablation at each or selected sites of, for example, ectopy or atrioventricular (A-V) nodal response as such sites are found and before moving to new sites. Still further, the energy generator 22 and/or control unit 14 may have an automated system, selectable by the operator, whereby ectopy, when detected may activate the ablation system to deliver ablative energy upon each detection of, for example, ectopic activity while moving the device on tissue sites and delivering pulsed stimulation to elicit ectopic responses.” The section identified by the applicant is therefore directed to the apparatus’ ability to treat ectopic sites that have been detected by the stimulation with ablation energy before moving to new sites that are identified as ectopic from delivered pulsed stimulation. It does not persuasively support the applicant’s argument that stimulation continues at the same rate whether or not ectopy is detected and ablation is performed.
Applicant's arguments filed January 8, 2026 with respect to Rosenberg et al. (US 2013/0066222) for failing to disclose the claimed invention have been fully considered but they are not persuasive. Applicant argues Rosenberg et al. does not disclose the use of a stimulation signal comprising high frequency stimulation pulses to trigger ectopic events, but this is not the rejection’s reason for relying on the teachings of Rosenberg et al., as the previous Office action identifies Stewart et al. of meeting the claimed limitation of using high frequency stimulation pulses to trigger ectopic events. Instead, the Office action relies on Rosenberg et al. to teach that a plurality of detection channels each carry a respective detection signal and to distinguish between ventricular activation events and ectopy events of an atrial channel.
Applicant's arguments filed January 8, 2026 with respect to Ding et al. (US 2013/0158621) for failing to disclose the claimed invention have been fully considered but they are not persuasive. Applicant argues Ding et al. does not disclose the use of a stimulation signal comprising high frequency stimulation pulses to trigger ectopic events, but this is not the rejection’s reason for relying on the teachings of Ding et al., as the previous Office action identifies Stewart et al. of meeting the claimed limitation of using high frequency stimulation pulses to trigger ectopic events. Instead, the Office action relies on Ding et al. to teach processing a detection signal from each of a plurality of atrial detection channels and identifying an event as an ectopy event only if it is detected in the detection signal from each of the atrial channels, and determine the timing of each ectopy event on each of the atrial channels to locate a source of an ectopy event.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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, 8, 10, 18-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al. (US 2016/0166310) in view of Rosenberg et al. (US 2013/0066222), Ding et al. (US 2013/0158621) and Blake, III (US 2017/0161896).
Regarding claim 1, Stewart et al. discloses an apparatus for electrophysiological studies, the apparatus comprising: at least one probe 12; a plurality of electrodes 18 (“mapping electrodes” [0019]; “pacing and sensing may be accomplished with the same electrode” [0039]); at least one output channel connected to at least one of the electrodes ([0022]); a plurality of detection channels each connected to a respective one of the electrodes and configured to carry a respective detection signal (“electrophysiology (EP) recording system, which may be a component of the control unit 14” [0023]; “pacing and sensing may be accomplished with the same electrode” [0039]); a controller 14, wherein the at least one output channel includes a stimulation channel (“delivering pulsed stimulation” [0022]), the controller is configured to provide a stimulation signal to the stimulation channel (“delivering pulsed stimulation” [0022]), wherein the stimulation channel is configured to trigger ectopy events (“delivering pulsed stimulation to elicit ectopic responses” [0022]) and comprises a plurality of high frequency stimulation pulses (“deliver stimulation pulses… at frequencies of approximately 20 Hz to 2000 Hz” [0022]), the stimulation pulses being arranged in groups (“deliver pulsed stimulation continuously or intermittently from the generator” [0022]), and to process detection signals to identify ectopy events triggered by the stimulation signal (“The response to stimulation may be manifested… the form of premature atrial contractions (ectopic activity). Such responses may be monitored by an electrophysiology (EP) recording system, which may be a component of the control unit 14” [0023]); the controller is further configured to stop producing the stimulation signal in response to a count of detected ectopy events increasing to a predetermined number (“ectopy, when detected may activate the ablation system to deliver ablative energy upon each detection of, for example, ectopic activity” [0022]; “Areas of high ectopic activity or A-V nodal response may be desired targets for ablation in order to effectively treat atrial fibrillation and other arrhythmias.” [0023]); and the controller is configured to track the position of the at least one probe ([0025], [0033]).
Stewart et al. does not expressly disclose the detection channels include an atrial channel and at least one reference channel; the controller is configured to process the detection signal received from the at least one reference channel after each of the groups of stimulation pulses, to identify ventricular activation events, thereby to distinguish between ventricular activation events and ectopy events in the detection signal from the atrial channel. Rosenberg et al. however teaches determining ectopy events by using a plurality of detection channels such as an RA sensing channel and a P4 channel as well as a PVARP and PVARP extension channel as reference channels ([0050]); where the reference channel detection signal is used to identify ventricular activation events, thereby distinguishing between ventricular activation events and ectopy events in the detection signal from the atrial channel ([0050], [0052]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stewart et al. and implement the disclosed discrimination techniques in order to better distinguish events sensed on the atrial channel as ectopic or otherwise ([0045], [0047]).
Stewart et al. does not expressly disclose the detection channels include a plurality of atrial channels and the controller is configured to process a detection signal from each of the atrial channels and to identify an event as an ectopy event only if it is detected in the detection signal from each of the atrial channels, and wherein the controller is configured to determine the timing of an ectopy event on each of said plurality of atrial channels, and from the timings to locate a source of the ectopy event. Ding et al. teaches a plurality of detection channels 15, 35, 65 extending through the atrium (E.N. atrial channels), and a controller 112 configured to process a detection signal from each of the atrial channels ([0078]) to identify an event as an ectopy event only if it is detected in the detection signal from each of the atrial channels ([0111], “if the current ectopic event occurs substantially proximally to the preceding ectopic event, or if the current ectopic event rate is greater than the preceding ectopic event rate by at least a threshold amount, then a first electrostimulation parameter can be adjusted” [0113]), and wherein the controller is configured to determine the timing of an ectopy event on each of said plurality of atrial channels, and from the timings to locate a source of the ectopy event (“timing information received from three or more electrode pairs can be used to precisely identify a location of the ectopic event, such as using triangulation” [0078]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stewart et al. to use a plurality of detection channels and to compare detection signals against each other or to a threshold in order to identify an ectopy event, and use timings to locate a source of the ectopy event as taught by Ding et al. in order to provide multiple sources of cardiac information that would better identify ectopy events.
Stewart et al. discloses the controller tracks the three-dimensional position in space of each of the electrodes 18 ([0033]),maps part or all of the heart chamber for all the selected sites of ectopy as they are found ([0022]) and determines a 3D position of the probe within the heart ([0025]) but does not expressly disclose the controller is configured to define a 3D model of the heart and to map the source of the ectopy event onto the 3D model of the heart. Blake, III teaches it is known in the art for a device to generate 3D simulations of electrical signal propagation across heart tissue to optimize catheter-ablation targets, these 3D models of the heart used to identify optimal ablation locations in order to therefore require the fewest and smallest ablations to treat and prevent further arrhythmia ([0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stewart et al. to incorporate defining a 3D model of the heart as taught by Blake, III and to map the source of the ectopy event onto the 3D model of the heart as Blake, III teaches using these 3D models to identify optimal ablation locations, in order to help visualize the location of each ectopy event and the desired ablation location prior to delivering treatment.
Regarding claim 2, Stewart et al. in view of Rosenberg et al. discloses the controller is further configured to identify ventricular activation events in the detection signals ([0050], [0052]).
Regarding claim 3, Stewart et al. discloses wherein the controller is configured to process the detection signals to produce an outcome (“to deliver ablative energy upon each detection of, for example, ectopic activity” [0022]) and to control the stimulation signal in response to the outcome.
Regarding claim 8, Stewart et al. in view of Rosenberg et al. disclose an atrial catheter, the atrial catheter comprising at least one atrial electrode, wherein the atrial channel is connected to said at least one atrial electrode ([0030], [0034]); and a ventricular catheter, the ventricular catheter comprising at least one ventricular electrode, wherein one of the at least one reference channels is connected to said at least one ventricular electrode ([0029], [0034]).
Regarding claim 10, Stewart et al. discloses an ECG electrode set wherein one of the at least one reference channels is connected to the ECG electrode set ([0034], [0037]). Stewart et al. in view of Rosenberg also disclose an ECG electrode set wherein one of the at least one reference channels is connected to the ECG electrode set ([0003]).
Regarding claim 18, Stewart et al. discloses wherein the at least one output channel includes a pacing channel (“the ability of bipolar or unipolar pacing pulses to achieve cardiac capture” [0039], [0041]) and the controller is configured to provide a pacing signal to the pacing channel (“the ability of bipolar or unipolar pacing pulses to achieve cardiac capture” [0039], [0041]); the pacing signal comprises a pacing pulse preceding each of said groups of stimulation pulses (“the energy delivered may be timed to follow the last pacing stimulus within the desired time window and when selected criteria are met that indicate proximity of the energy delivery electrodes 18 to the target tissue” [0041]).
Regarding claim 19, Stewart et al. discloses the controller is operable in an ectopy triggering mode in which the system is arranged to produce the pacing pulses ([0039], [0041]) and the groups of stimulation pulses ([0022]), and an atrioventricular node slowing mode in which the system is arranged to produce the stimulation pulses without the pacing pulses ([0023]).
Regarding claim 20, Stewart et al. discloses the controller comprises a user interface 28 arranged to enable a user to select one of the modes and to adjust at least one parameter of the stimulation signal or the pacing signal ([0024]).
Regarding claim 21, Stewart et al. discloses the controller is configured to perform a ventricular activation test in which the pacing signal is output without the stimulation signal (“the origins of focal sites of activation may be detected by intracardiac multi-electrode arrays or body surface electrode-based maps of cardiac conduction” [0035]), and the user interface only enables a user to start the stimulation signal after the ventricular activation test has been completed ([0037], [0039]).
Regarding claim 22, Stewart et al. discloses wherein each of the stimulation pulses is a bipolar voltage pulse ([0009], [0030], [0032]).
Regarding claim 23, Stewart et al. discloses wherein the controller is arranged to define a target current and to control the stimulation signal during each of the stimulation pulses to achieve the target current ([0022]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al. (US 2016/0166310) in view of Rosenberg et al. (US 2013/0066222), Ding et al. (US 2013/0158621) and Blake, III (US 2017/0161896) and further in view of Rueter et al. (US 2004/0088019).
Regarding claim 11, Stewart et al. discloses the at least one output channel includes a pacing channel (“the ability of bipolar or unipolar pacing pulses to achieve cardiac capture” [0039], [0041]) and the controller is configured to: provide a pacing signal (“the ability of bipolar or unipolar pacing pulses to achieve cardiac capture” [0039], [0041]) to the pacing channel, but does not expressly disclose identify ventricular activation events that are caused by the pacing signal and to modify or stop the pacing signal in response to the identification of a predetermined number of ventricular activation events that are identified as caused by the pacing signal; perform a ventricular activation test in which the pacing signal is output without the stimulation signal; and enable the stimulation signal only after the ventricular activation test has passed. Rueter et al. teaches techniques for determining a ventricular sensing window based on observed ventricular senses during a pacing stimulation threshold test. A pacemaker delivers pacing signals (“test pulses”) and ventricular senses are then observed in response until a number of senses are detected within a ventricular sensing window ([0007-0009]). Rueter et al. teaches this pacing threshold test outputs these test pulses, that are different from standard stimulation signals (“pacing pulses”) and the stimulation pulses are enabled only after the pacing stimulation threshold test has been passed ([0006], [0032]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stewart et al. with the techniques taught by Rueter et al. in order to increase the accuracy of capture detection therefore assist in selecting minimum pacing amplitudes and thereby conserving battery resources ([0014]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al. (US 2016/0166310) in view of Rosenberg et al. (US 2013/0066222), Ding et al. (US 2013/0158621) and Blake, III (US 2017/0161896) and further in view of Ghosh (US 2018/0326215).
Regarding claim 15, Stewart et al. does not expressly disclose wherein the controller is configured to process the detections to identify two consecutive ventricular events, to measure a delay between said consecutive ventricular events, and to determine whether the delay exceeds a predetermined time period. Ghosh teaches it is known in the art to identify two consecutive measured ventricular activation times, determine if the activation time is greater than a predetermined time period (“predetermined reference activation time”) and to modify stimulation parameters accordingly ([0119]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stewart et al. to apply the known technique of monitoring ventricular activation times and comparing them to a threshold as taught by Ghosh to improve the device and respond accordingly with modified stimulation parameters when necessary.
Allowable Subject Matter
Claim 24 is allowed.
The following is a statement of reasons for the indication of allowable subject matter: Claim 24 is directed to an apparatus comprising at least one output channel comprising a stimulation channel; a plurality of detection channels each configured to carry a respective detection signal, the detection channels including an atrial channel and at least one reference channel; a controller configured to provide a stimulation signal to the stimulation channel, the stimulation signal is configured to trigger ectopy events and comprises a plurality of high frequency stimulation pulses arranged in groups; and the controller is configured to receive the detection signals from the atrial channel after each of the groups of stimulation pulses and to process the detection signals thereby to identify, in the detection signals, ectopy events triggered by the stimulation signal; and the controller is configured to process the detection signal received from the at least one reference channel after each of the groups of stimulation pulses, to identify ventricular activation events, thereby to distinguish between ventricular activation events and ectopy events in the detection signal from the atrial channel. The controller is further configured to stop producing the stimulation signal in response to a count of detected ectopy events increasing to a predetermined number; and wherein the stimulation signal is applied across two stimulation electrode and the controller is arranged to control the impedance between the stimulation electrodes between the stimulation pulses thereby to control and offset voltage between the electrodes. Stewart et al. (US 2016/0166310) in view of Rosenberg et al. (US 2013/0066222) disclose the claimed invention but do not disclose wherein the stimulation signal is applied across two stimulation electrode and the controller is arranged to control the impedance between the stimulation electrodes between the stimulation pulses thereby to control and offset voltage between the electrodes.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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