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 Arguments
Applicant’s arguments, see pages 10-11, filed 08/21/2026, with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been obviated by amendments to the drawings and specification. The objections of the drawings have been withdrawn.
Applicant’s arguments, see page 11, filed 08/21/2026, with respect to 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections have been obviated by amendments to the claims. The previously-held 35 U.S.C. 112(b) rejections have been withdrawn. However, new 35 U.S.C. 112(b) rejections are now made herein that are necessitated by the amendments.
Applicant’s arguments, see page 11, filed 08/21/2026, with respect to 35 U.S.C. 101 rejections have been fully considered and are persuasive. The 35 U.S.C. 101 rejections have been obviated by amendments to the claims. The 35 U.S.C. 101 rejections have been withdrawn.
Applicant’s arguments, see pages 11-15, filed 08/21/2026, with respect to 35 U.S.C. 102 and 103 rejections have been fully considered but they are not persuasive. The Applicant argues that amended independent claims 1 and 8 particularly require a directly preceding ventricular event is temporarily suspended or disabled and the current intrinsic ventricular event is classified as non-VES ventricular event. The Applicant argues that the citations to Qiao and Buchanan for teaching the indicated claim limitations is a mischaracterization of Qiao and Buchanan. With reference to Par. [0060] of Qiao, the Applicant argues that pausing the algorithm does not translate into suspending a directly preceding event. With reference to Par. [0077] of Qiao, the Applicant argues that not utilizing the identified PVC does not translate into the current intrinsic ventricular event being classified as non-VES ventricular event. With reference to 6:67-7:17 of Buchanan, the Applicant argues that this disclosure does not translate into suspending a directly preceding event and classifying the current intrinsic ventricular event as non-VES. The Applicant argues that there is nothing in these paragraphs specifically suspending a directly preceding ventricular event and there is nothing suggesting classifying the current intrinsic ventricular event as a non-VES event.
This is not found persuasive. The Examiner first notes that the 35 U.S.C. 103 rejection in view of Buchanan and the Applicant’s arguments directed to Buchanan are now rendered moot. The Examiner notes that Buchanan was previously brought in for previous claims 4 and 10, which are now canceled. The limitation of previous claims 4 and 10 have been brought into claims 1 and 8, but have been brought in as one option in a list of three options in claims 1 and 8, therefore not requiring that this particular limitation be taught by Qiao in order for Qiao to teach the claims as a whole (i.e., as long as Qiao teaches one of the other two options). Therefore, the 35 U.S.C. 103 rejection in view of Buchanan and the use of Buchanan is currently rendered moot and not relied on in this present Office Action.
Regarding the Applicant’s arguments directed to Qiao, the Examiner disagrees and maintains the 35 U.S.C. 102 rejections over Qiao. The Examiner maintains that at least Par. [0077] of Qiao, in view of the corresponding components of Fig. 3, teaches the limitation involving “wherein application … from the directly preceding ventricular event is at least temporarily suspended or disabled and the current intrinsic ventricular event is classified … as non-VES ventricular event”. Qiao teaches that at step 322, the one or more processors determine if a determined number of the series of beats in a row are considered a PVC and if a patient has a changed posture, is exercising, etc., or if a faulty reading is causing the median to be incorrect, etc. this may be an indication that PVCs are not presented (Par. [0077]). Qiao further teaches that if the determine number is reached, then at 324 both the RRI and morphology are updated with the PVC identified RRIs and morphology (Par. [0077]). Qiao further teaches that while typically the CA signal with the identified PVC is not utilized in the RRI threshold and morphology threshold determination, after the number is reached, then each CA signal is utilized for RRI threshold and morphology threshold determinations (Par. [0077]). Qiao teaches that upon identification of the fourth straight beat, the oldest four RRI and morphology determinations are discarded, and all four of the CA signals with the identified PVCs are utilized to determine the RRI threshold and morphology threshold (Par. [0077]). The Examiner disagrees with the Applicant’s argument directed to Par. [0077] of Qiao that not utilizing the identified PVC does not translate into the current intrinsic ventricular event being classified as non-VES ventricular event. In fact, the Examiner finds this characterization of how Qiao is showing the current intrinsic ventricular event as being classified as non-VES ventricular event to be incorrect. Qiao explains at the beginning of Par. [0077] that there are reasons (e.g., changing posture, exercising, faulty readings, etc.) for why PVCs aren’t presented even though they are first detected as a PVC, and that these situations are taken care of in method step 322 of Fig. 3. So, Par. [0077] is specifically directed to the purpose of classifying the current intrinsic event as a non-VES ventricular event and then utilizing it as part of the new RRI and morphology (Step 324). The action of utilizing (i.e., not “not utilizing”, as the Applicant suggests) the detected 4 or more consecutive PVC beats as part of the new RRI and morphology is effectively classifying the current intrinsic ventricular event as non-VES ventricular event. The Examiner contends also that the application must also be at least temporarily suspended when the new RRI and morphology is updated in step 324. Therefore, the 35 U.S.C. 102 rejections over Qiao are maintained. Please see 35 U.S.C. 102 rejections hereinbelow.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation “a prematurity criterion” in line 1, whereas a prematurity criterion was already introduced in a claim that claim 2 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different prematurity criterion. Consider changing to “the prematurity criterion”.
Claim 2 recites the limitation “a pre-defined cardiac cycle prematurity duration threshold” in lines 4-5, whereas a pre-defined cardiac cycle prematurity duration threshold was already introduced in a claim that claim 2 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different pre-defined cardiac cycle prematurity duration threshold. Consider changing to “the pre-defined cardiac cycle prematurity duration threshold”.
Claim 9 recites the limitation “a pre-defined cardiac cycle prematurity duration threshold” in line 5, whereas a pre-defined cardiac cycle prematurity duration threshold was already introduced in a claim that claim 9 depends from (claim 8). It is unclear whether the Applicant intended to claim the same or a different pre-defined cardiac cycle prematurity duration threshold. Consider changing to “the pre-defined cardiac cycle prematurity duration threshold”.
*Claim 3 is rejected due to its dependency on a rejected claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 7-9, and 13-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Qiao, et al. (U.S. PGPub No. 2022/0240830).
Regarding claim 1, Qiao teaches (Figs. 1-2, # 100 – ICM (implantable cardiac monitor), i.e., intracardiac medical device; Fig. 3, # 300 – method) a method of operating an intracardiac medical device within a patient's heart (Par. [0100] – FIG. 1 illustrates an ICM 100 intended for subcutaneous implantation at a site near the heart; Par. [0059] – FIG. 3 illustrates a method 300 for identifying PVCs. In one example, one or more processors of a ICM implement the method 300.), wherein (Fig. 2, # 121 – programmable microcontroller, i.e. processing unit, 134 – arrhythmia detector, i.e. detector, 136 – ORI process, i.e. part of detector; 138 – PVC ID System, i.e. coupled to the detector) the medical device comprises a processing unit and a detector (Par. [0041] – The ICM 100 includes a programmable microcontroller 121 that controls various operations of the ICM 100, including cardiac monitoring.; Par. [0043] – Microcontroller 121 includes an arrhythmia detector 134 that is configured to analyze cardiac activity signals to identify potential arrhythmia episodes (e.g., Tachycardias, Bradycardias, Asystole, Brady pause, atrial fibrillation, etc.).; Par. [0045] – The ICM also includes a PVC identification system 138 that is coupled to the arrhythmia detector 134. In particular, the PVC identification system 138 monitors a COI of a segment of a CA signal to determine whether or not to trigger determining if a CA signal provides a PVC.), wherein the detector detects time-dependent electrical signals of the heart including ventricular events and transmits the detected electrical signals to the processing unit (Par. [0026] – non-limiting examples of cardiac activity signals include ECG signals collected by cutaneous electrodes, and EGM signals collected by subcutaneous electrodes and/or by electrodes positioned within or proximate to the heart wall and/or chambers of the heart; Par. [0043] – Microcontroller 121 includes an arrhythmia detector 134 that is configured to analyze cardiac activity signals to identify potential arrhythmia episodes (e.g., Tachycardias, Bradycardias, Asystole, Brady pause, atrial fibrillation, etc.).; Par. [0045] – the PVC identification system 138 monitors a COI of a segment of a CA signal to determine whether or not to trigger determining if a CA signal provides a PVC.), wherein (Fig. 3, # 300, 304, 306, 312, 320) the processing unit classifies a current intrinsic ventricular event of the received electrical signals as a ventricular extrasystole when a temporal distance of the current intrinsic ventricular event from a directly preceding ventricular event meets at least one pre-determined prematurity criterion and otherwise as a non-VES ventricular event (Par. [0061-0062] – then at 304, the one or more processors determine if a COI of a segment of a CA signal exceeds a COI limit. In one example the COI is a RRI of a candidate beat, and if the RRI is below a threshold related to the series of beats, the COI limit is exceeded.; Par. [0063] – If at 304 the candidate beat does not exceed the COI limit, then at 306, the one or more processors update a CA signal morphology.; Par. [0066] - To this end, if at 304, the COI limit is exceeded, then the one or more processors at 312 analyze morphology of the CA signals for the series of beats responsive to the first segment of the CA signals exceeding the COI limit.; Par. [0076] – If at 312, a determination is made that the CA signal for the series of beats includes a PVC [(PVC = premature ventricular contraction, i.e. ventricular extrasystole)], at 320 the one or more processors mark the beat as a PVC.),
wherein (Fig. 3, # 322 and 324) application of the at least one pre-determined prematurity criterion to the temporal distance of the current intrinsic ventricular event from the directly preceding ventricular event is at least temporarily suspended or disabled and the current intrinsic ventricular event is classified by the processing unit as non-VES ventricular event:
when an atrial event is detected by the processing unit from the received electrical signals after the directly preceding ventricular event and/or when the atrial event is detected in a temporal distance from the current intrinsic ventricular event shorter than a pre-defined cardiac cycle prematurity duration threshold;
at least during a time period in which a state determining module of the processing unit uses at least one pre-determined state of a plurality of states (Par. [0045] – In this manner, when events occur such as exercise, sleep, posture change, or the like, that naturally varies the RRI, such variance is considered.; Par. [0077] – At 322 … In particular, if a patient has a changed posture, is exercising, etc., or if a faulty reading is causing the median to be incorrect, etc. this may be an indication that PVCs are not presented.; The Examiner notes that “a changed posture, exercising, etc., or a faulty reading, etc.” corresponds to pre-determined states); and/or
at least during a time period in which a pre-defined VES suspension criterion is met (Par. [0077] – At 322, the one or more processors determine if a determined number of the series of beats in a row are considered a PVC. In particular, if a patient has a changed posture, is exercising, etc., or if a faulty reading is causing the median to be incorrect, etc. this may be an indication that PVCs are not presented. So, if the determined number is not reached, the one or more processors continue to monitor the CA signals. However, if the determine number is reached, then at 324 then both the RRI and morphology are updated with the PVC identified RRIs and morphology.).
Therefore, claim 1 is unpatentable over Qiao, et al.
Regarding claim 2, Qiao teaches the method of claim 1, wherein (Fig. 3, # 304 – RRI (RR-interval)<=87.5%, i.e. prematurity criterion) a prematurity criterion is met when the temporal distance of the current intrinsic ventricular event from the directly preceding ventricular event is shorter than an expected duration of one cardiac cycle and/or is equal to or less than a pre-defined cardiac cycle prematurity duration threshold (Par. [0061-0062] – In one example, the threshold for a candidate CA signal is less than 87.5% of a median of the previous three CA signals. By continuously monitoring and determining if the RRI of a most recent, candidate CA signal is below the threshold, and not moving forward with analyzing whether the CA signals present a PVC until such a threshold is exceeded, the threshold presents a buffer for preventing battery use to identify if a PVC is present when a PVC is not presented.).
Therefore, claim 2 is unpatentable over Qiao, et al.
Regarding claim 3, Qiao teaches the method of claim 2, wherein (Fig. 3, # 304) the expected duration of one cardiac cycle is a duration of a most recent cardiac cycle without any VES or is an average of durations of a pre-defined number of most recent cardiac cycles without any VES (Par. [0061] – For example, the threshold may be based on an average of the series of beats, a portion of the series of beats, etc.).
Therefore, claim 3 is unpatentable over Qiao, et al.
Regarding claim 7, Qiao teaches the method of claim 1, wherein (Fig.3, # 324 and 302) application of the at least one pre-determined prematurity criterion to the temporal distance of the current intrinsic ventricular event from the directly preceding ventricular event is re-enabled when a pre-defined VES re-enablement criterion is met (Par. [0077] – upon identification of the fourth straight beat, the oldest four RRI and morphology determinations are discarded, and all four of the CA signals with the identified PVCs are utilized to determine the RRI threshold and morphology threshold; Examiner notes that RRI and morphology rolling buffers must be met to re-enable the application (i.e., re-enablement criterion); Par. [0060] – At 302, for a candidate beat, the one or more processors determine if a noise threshold is exceeded for the beat. Specifically, to prevent inappropriate detection due to noise oversensing, the algorithm is paused when the device is in noise reversion or noise recovery; Examiner also notes that the noise threshold must also be cleared at step 302 in order to proceed with the algorithm, which could also be considered a re-enablement criterion).
Therefore, claim 7 is unpatentable over Qiao, et al.
Regarding claim 8, Qiao teaches (Figs. 1-2, # 100 – ICM (Implantable Cardiac Monitors), i.e. intracardiac medical device) an intracardiac medical device (Par. [0003]; Par. [0036]) comprising (Fig. 2, # 121 – programmable microcontroller, i.e. processing unit, 134 – arrhythmia detector, i.e. detector, 136 – ORI process, i.e. part of detector; 138 – PVC ID System, i.e. coupled to the detector) a processing unit and a detector (Par. [0041] – The ICM 100 includes a programmable microcontroller 121 that controls various operations of the ICM 100, including cardiac monitoring.; Par. [0043] – Microcontroller 121 includes an arrhythmia detector 134 that is configured to analyze cardiac activity signals to identify potential arrhythmia episodes (e.g., Tachycardias, Bradycardias, Asystole, Brady pause, atrial fibrillation, etc.).; Par. [0045] – The ICM also includes a PVC identification system 138 that is coupled to the arrhythmia detector 134. In particular, the PVC identification system 138 monitors a COI of a segment of a CA signal to determine whether or not to trigger determining if a CA signal provides a PVC.) configured to detect time-dependent electrical signals of the heart including ventricular events and to transmit the detected electrical signals to the processing unit (Par. [0026] – non-limiting examples of cardiac activity signals include ECG signals collected by cutaneous electrodes, and EGM signals collected by subcutaneous electrodes and/or by electrodes positioned within or proximate to the heart wall and/or chambers of the heart; Par. [0043] – Microcontroller 121 includes an arrhythmia detector 134 that is configured to analyze cardiac activity signals to identify potential arrhythmia episodes (e.g., Tachycardias, Bradycardias, Asystole, Brady pause, atrial fibrillation, etc.).; Par. [0045] – the PVC identification system 138 monitors a COI of a segment of a CA signal to determine whether or not to trigger determining if a CA signal provides a PVC.), wherein (Fig. 3, # 300, 304, 306, 312, 320) the processing unit is configured to classify a current intrinsic ventricular event of the received electrical signals as a ventricular extrasystole when a temporal distance of the current intrinsic ventricular event from a directly preceding ventricular event meets at least one pre-determined prematurity criterion and to classify the current intrinsic ventricular event otherwise as a non-VES ventricular event (Par. [0061-0062] – then at 304, the one or more processors determine if a COI of a segment of a CA signal exceeds a COI limit. In one example the COI is a RRI of a candidate beat, and if the RRI is below a threshold related to the series of beats, the COI limit is exceeded.; Par. [0063] – If at 304 the candidate beat does not exceed the COI limit, then at 306, the one or more processors update a CA signal morphology.; Par. [0066] - To this end, if at 304, the COI limit is exceeded, then the one or more processors at 312 analyze morphology of the CA signals for the series of beats responsive to the first segment of the CA signals exceeding the COI limit.; Par. [0076] – If at 312, a determination is made that the CA signal for the series of beats includes a PVC [(PVC = premature ventricular contraction, i.e. ventricular extrasystole)], at 320 the one or more processors mark the beat as a PVC.);
wherein (Fig. 2, # 121; Fig. 3, # 322 and 324) the processing unit is configured such that an application of the at least one pre-determined prematurity criterion to the temporal distance of the current intrinsic ventricular event from the directly preceding ventricular event is suspended and the current intrinsic ventricular event is classified as non-VES ventricular event:
when an atrial event is detected by the processing unit from the received electrical signals after the directly preceding ventricular event and/or when the atrial event is detected in a temporal distance from the current intrinsic ventricular event shorter than a pre-defined cardiac cycle prematurity duration threshold;
at least during a time period in which a state determining module of the processing unit uses at least one pre-determined state of a plurality of states (Par. [0045] – In this manner, when events occur such as exercise, sleep, posture change, or the like, that naturally varies the RRI, such variance is considered.; Par. [0077] – At 322 … In particular, if a patient has a changed posture, is exercising, etc., or if a faulty reading is causing the median to be incorrect, etc. this may be an indication that PVCs are not presented.; The Examiner notes that “a changed posture, exercising, etc., or a faulty reading, etc.” corresponds to pre-determined states); and/or
at least during a time period in which a pre-defined VES suspension criterion is met (Par. [0077] – At 322, the one or more processors determine if a determined number of the series of beats in a row are considered a PVC. In particular, if a patient has a changed posture, is exercising, etc., or if a faulty reading is causing the median to be incorrect, etc. this may be an indication that PVCs are not presented. So, if the determined number is not reached, the one or more processors continue to monitor the CA signals. However, if the determine number is reached, then at 324 then both the RRI and morphology are updated with the PVC identified RRIs and morphology.).
Therefore, claim 8 is unpatentable over Qiao, et al.
Regarding claim 9, Qiao teaches the medical device of claim 8, wherein (Fig. 3, # 304 – RRI (RR-interval)<=87.5%, i.e. prematurity criterion) the processing unit is configured such that the at least one pre-determined prematurity criterion is met when the temporal distance of the current intrinsic ventricular event from the directly preceding ventricular event is shorter than an expected duration of one cardiac cycle and/or is equal to or less than a pre-defined cardiac cycle prematurity duration threshold (Par. [0061-0062] – In one example, the threshold for a candidate CA signal is less than 87.5% of a median of the previous three CA signals. By continuously monitoring and determining if the RRI of a most recent, candidate CA signal is below the threshold, and not moving forward with analyzing whether the CA signals present a PVC until such a threshold is exceeded, the threshold presents a buffer for preventing battery use to identify if a PVC is present when a PVC is not presented.), wherein (Fig. 3, # 304) the expected duration of one cardiac cycle is the duration of the most recent cardiac cycle without any VES or is an average of the durations of a pre-defined number of most recent cardiac cycles without any VES (Par. [0061] – For example, the threshold may be based on an average of the series of beats, a portion of the series of beats, etc.).
Therefore, claim 9 is unpatentable over Qiao, et al.
Regarding claim 13, Qiao teaches the medical device of claim 8, wherein (Fig. 2, # 121; Fig. 3, # 322 and 324) the processing unit is configured such that an application of the at least one pre-determined prematurity criterion to the temporal distance of the current intrinsic ventricular event from the directly preceding ventricular event is re-enabled when a pre-defined VES re-enablement criterion is met (Par. [0077] – upon identification of the fourth straight beat, the oldest four RRI and morphology determinations are discarded, and all four of the CA signals with the identified PVCs are utilized to determine the RRI threshold and morphology threshold; Examiner notes that RRI and morphology rolling buffers must be met to re-enable the application (i.e., re-enablement criterion); Par. [0060] – At 302, for a candidate beat, the one or more processors determine if a noise threshold is exceeded for the beat. Specifically, to prevent inappropriate detection due to noise oversensing, the algorithm is paused when the device is in noise reversion or noise recovery; Examiner also notes that the noise threshold must also be cleared at step 302 in order to proceed with the algorithm, which could also be considered a re-enablement criterion).
Therefore, claim 13 is unpatentable over Qiao, et al.
Regarding claim 14, Qiao teaches (Fig. 2, # 121) a computer program product including non-volatile memory (Par. [0043] – Although not shown, the microcontroller 121 may further include other dedicated circuitry and/or firmware/software components that assist in monitoring various conditions of the patient's heart and managing pacing therapies.; Par. [0090-0091]) comprising instructions which, when executed by the processing unit, cause the processing unit to perform the steps of the method according to claim 1 (please see rejection of claim 1 hereinabove).
Therefore, claim 14 is unpatentable over Qiao, et al.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
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