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 on Feb. 27, 2026 has been entered. Claims 1 and 3-10 remain pending in the application. Applicant’s amendments to the 112(f), 112(b), and 101 rejections previously set forth in the Non-Final Office Action mailed Nov. 10, 2025 have overcome each and every rejection.
Response to Arguments
35 U.S.C. § 112(f)
Applicant amended claim 1 to provide the lacking structure from originally filed claim 1. This successfully overcomes the previous claim interpretation under 35 U.S.C. 112(f).
35 U.S.C. § 112(b)
Applicant amended claim 1 to eliminate indefinite language from originally filed claim 1. This successfully overcomes the previous rejection under 35 U.S.C. 112(b) and the rejection is withdrawn.
35 U.S.C. § 101
Applicant amended claim 1 to incorporate limitations from originally filed dependent claim 2. The argument regarding the millisecond timescale creates the grounds for this withdrawal. This successfully overcomes the previous rejection under 35 U.S.C. 101 and the rejection is withdrawn.
35 U.S.C. § 103
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. It is further noted that in the previous Office action dated Nov. 10, 2025, claim 8, which was clearly included in the body of the rejection on p9, was inadvertently omitted from the rejection heading in item 10 on p8.
Double Patenting
Applicant’s response that claim 6 of the copending Application No. 18/538,322 will be canceled has been fully considered. Since currently claim 6 in co-pending Application No. 18/538,322 is still pending, the double patenting rejection has been maintained.
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, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et. al (US 20140350621 A1, published 11/27/2014, hereinafter known as Gunderson), in view of Sakamoto (WO 2021251088, published 12/16/2021), further in view of Bhatt (What happens during electrical cardioversion?, Harvard Health Publishing, https://www.health.harvard.edu/heart-health/what-happens-during-electrical-cardioversion#:~:text=After%20you%27re%20sedated,%20the,on%20your%20risk%20of%20stroke, published 08/01/2022), and further in view of Fischell (US 4295474 A, published 10/20/1981). For Sakamoto reference, US 20230181917 A1 has been used as an equivalent document for WO 2021251088.
Regarding claim 1, Gunderson discloses a defibrillation control device, comprising: a processor (“controller may be embodied as a processor” [0046]), a memory storing instructions that (“memory may store computer-readable instructions” [0048]), when executed by the processor, cause the processor to perform operations (“when executed by controller, cause IMD (implantable medical device) to perform various functions” [0048]) comprising: detecting an earliest abnormal waveform (“the EGM (or ECG) signal, is acquired and analyzed at block in real time to detect an abnormality”, if an abnormality were detected, this can be considered the earliest abnormal waveform considering that no other abnormal waveform was previously detected, [0113]) by using a plurality of electrocardiographic waveforms (“an electrocardiogram (ECG) signal may be acquired” [0088]) measured by a plurality of electrodes (“the medical electrical lead includes a plurality of electrodes” [0009]), wherein the detecting the earliest abnormal waveform comprises: detecting an earliest waveform having an earliest start timing at which an amplitude is equal to or greater than a first threshold value (“the SC detection threshold is set to differentiate the SC signal event from true R-waves based on amplitude…if the peak amplitude of the sensed signal is greater than the SC detection threshold, the signal is detected as an SC event” [0059], [0065]), among the plurality of electrocardiographic waveforms; determining whether the earliest waveform is normal or abnormal using the earliest waveform (“acquire the first cardiac signal when the lead monitoring condition is met, analyze the first cardiac signal to detect an abnormality of the first cardiac signal” [0009]); and detecting the earliest abnormal waveform when the earliest waveform is determined to be abnormal (“the EGM (or ECG) signal, is acquired and analyzed at block in real time to detect an abnormality”, if an abnormality were detected, this can be considered the earliest abnormal waveform considering that no other abnormal waveform was previously detected, [0113]).
Gunderson does not disclose a power source unit that supplies electrical energy to an electrode catheter; detecting the earliest abnormal waveform on a millisecond timescale by using a plurality of waveforms measured by the plurality of electrodes of the electrode catheter.
However, Sakamoto teaches a defibrillating electrical apparatus (Abstract). The apparatus contains a power source unit configured to generate applied voltage [0089] for the catheter having…a plurality of electrodes provided at a distal portion [0108]. An enabling signal is preferably generated within 60 milliseconds after the first time interval T.sub.1 exceeds the first predetermined time period [0084]. The respective electrodes measure local potential even during defibrillation [0111]. The defibrillating electrical apparatus and the defibrillation signal generation method allow a T wave included in a detected R wave to be reliably excluded from a voltage application target. Furthermore, the defibrillating electrical apparatus and the defibrillation signal generation method facilitate selection of an appropriate R wave as a voltage application target, from R waves having a narrow interval therebetween, and enable voltage application for defibrillation [0056].
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 power source, plurality of electrodes in an electrode catheter that can make measurements, and millisecond time interval of Sakamoto with the defibrillation control device of Gunderson in order to enable effective voltage application for defibrillation timely.
While Gunderson’s device is for delivering cardioversion and defibrillation shocks [0029], Gunderson in view of Sakamoto still does not disclose the detection of the earliest abnormal waveform after supplying the electrical energy.
However, Bhatt teaches that electrical cardioversion is a procedure to convert a rapid or irregular heartbeat back to a normal rhythm, in which the heart is shocked with electricity (p2). Although electrical cardioversion is not exactly the same as defibrillation, both treatments are for treating abnormal heart rhythms. After electrical cardioversion, the patient will be monitored for a few hours afterward, as the heart may revert to an abnormal rhythm (pp3-4).
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 measurement of electrocardiographic waveforms of Bhatt with the modified defibrillation apparatus of Gunderson because this ensures that the shock to the heart was successful and the heart is beating in a normal rhythm (p4 of Bhatt).
Gunderson in view of Sakamoto and Harvard Health Publishing still do not disclose issuing an alert upon detecting the earliest abnormal waveform.
However, Fischell teaches a system and apparatus, adapted for use with an automatic implantable defibrillator (Abstract). Wherein an alert occurs after the patient has undergone a defibrillation sequence and is being alerted to visit his/her physician immediately (Col. 16, lines 6-9). Gunderson and Fischell are considered to be analogous to the claimed invention because both are in the same field of defibrillation devices.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to make a simple addition of the warning unit of Fischell with the modified defibrillation apparatus of Gunderson because it is well known in the art that after defibrillation occurs, it is vital that the patient is confirmed to be in a healthy state, and that any remaining cardiac problems are addressed and diagnosed (Fischell, Col. 1, lines 38-40).
Regarding claim 8, in the modified device of Gunderson as described in claim 1, Gunderson does not disclose a display unit that displays information indicating which of the plurality of electrodes is an electrode from which the earliest abnormal waveform is acquired.
However, Sakamoto teaches a display unit configured to display an electrocardiographic waveform [0114]. A display will display the relevant information sent to it by a processor, essentially, what it is configured to display. It is noted that the current wording of claim 8 merely requires that Sakamoto teach a display that is capable of performing the recited limitations, and Sakamoto teaches such a display.
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 display unit of Sakamoto with the modified defibrillation apparatus of Gunderson because it allows for the user of the device to more easily monitor and assess the situation using the displayed information.
Regarding claim 10, Gunderson discloses a defibrillation control device, comprising: a processor (“controller may be embodied as a processor” [0046]), a memory storing instructions that (“memory may store computer-readable instructions” [0048]), when executed by the processor, cause the processor to perform operations (“when executed by controller, cause IMD (implantable medical device) to perform various functions” [0048]) comprising: detecting an earliest abnormal waveform (“the EGM (or ECG) signal, is acquired and analyzed at block in real time to detect an abnormality”, if an abnormality were detected, this can be considered the earliest abnormal waveform considering that no other abnormal waveform was previously detected, [0113]) by using a plurality of electrocardiographic waveforms (“an electrocardiogram (ECG) signal may be acquired” [0088]) measured by a plurality of electrodes (“the medical electrical lead includes a plurality of electrodes” [0009]), and ending the detecting the earliest abnormal waveform when the earliest abnormal waveform is detected or when neither the earliest abnormal waveform nor cardiac arrest is detected within 10 seconds (“an epoch of data (e.g., 10 sec) could be stored at regular intervals in the memory or triggered storage based on a detected event”, by storing data in the memory in intervals of 10 seconds each, the measurements will have to stop and subsequently restart after every 10 second interval, only a measured event will trigger memory storage sooner than the 10 second interval, [0039]).
Gunderson does not disclose a power source unit that supplies electrical energy to an electrode catheter; detecting the earliest abnormal waveform on a millisecond timescale by using a plurality of waveforms measured by the plurality of electrodes of the electrode catheter.
However, Sakamoto teaches a defibrillating electrical apparatus (Abstract). The apparatus contains a power source unit configured to generate applied voltage [0089] for the catheter having…a plurality of electrodes provided at a distal portion [0108]. An enabling signal is preferably generated within 60 milliseconds after the first time interval T.sub.1 exceeds the first predetermined time period [0084]. The respective electrodes measure local potential even during defibrillation [0111].
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 power source, plurality of electrodes in an electrode catheter that can make measurements, and millisecond time interval of Sakamoto with the defibrillation control device of Gunderson because it satisfies the recent uptick in demands for development of a defibrillation apparatus including an enabling signal generator mechanism (Sakamoto, [0006]).
Gunderson in view of Sakamoto still does not disclose the detection of the earliest abnormal waveform after supplying the electrical energy and ending the detecting the earliest abnormal waveform after the completion of the supply of electrical energy.
However, Bhatt teaches that electrical cardioversion is a procedure to convert a rapid or irregular heartbeat back to a normal rhythm, in which the heart is shocked with electricity as set forth above.
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 measurement of electrocardiographic waveforms of Harvard Health Publishing with the modified defibrillation apparatus of Gunderson because this ensures that the shock to the heart was successful and the heart is beating in a normal rhythm (p4 of Bhatt).
Gunderson in view of Sakamoto and Harvard Health Publishing still do not disclose issuing an alert upon detecting the earliest abnormal waveform.
However, Fischell teaches a system and apparatus, adapted for use with an automatic implantable defibrillator (Abstract). Wherein an alert occurs after the patient has undergone a defibrillation sequence and is being alerted to visit his/her physician immediately (Col. 16, lines 6-9). Gunderson and Fischell are considered to be analogous to the claimed invention because both are in the same field of defibrillation devices.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to make a simple addition of the warning unit of Fischell with the modified defibrillation apparatus of Gunderson because it is well known in the art that after defibrillation occurs, it is vital that the patient is confirmed to be in a healthy state, and that any remaining cardiac problems are addressed and diagnosed (Fischell, Col. 1, lines 38-40).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying online/eterminal-disclaimer.
Claim 1 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of co-pending Application No. 18/538,322 in view of Fischell.
This is a provisional nonstatutory double patenting rejection.
Claim 6 of Application No. 18/538,322 discloses a defibrillation control device comprising: a power source unit that supplies electrical energy to an electrode catheter; and a processor that detects an earliest abnormal waveform by using a plurality of electrocardiographic waveforms measured by a plurality of electrodes of the electrode catheter after supplying the electrical energy. The power source unit as referenced, can be referred to as the waveform providing unit in the co-pending application.
Regarding the warning unit, Fischell teaches wherein an alert occurs after the patient has undergone a defibrillation sequence and is being alerted to visit his/her physician immediately (Col. 16, lines 6-9).
Kojima and Fischell are considered to be analogous to the claimed invention because both are in the same field of defibrillation devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to make a simple addition of the warning unit of Fischell with the defibrillation apparatus of Kojima because it is well known in the art that after defibrillation occurs, it is vital that the patient is confirmed to be in a healthy state, and that any remaining cardiac problems are addressed and diagnosed (Fischell, Col. 1 lines 38-40).
Conclusion
Applicant’s amendment necessitated the new grounds 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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/F.M.K./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792