DETAILED ACTION
This Office Action is in response to the communication dated 27 August 2026 concerning Application No. 18/510,747 filed on 16 November 2023.
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 .
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 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.
Status of Claims
Claims 34-65 are pending; claims 44-53 have been withdrawn; claims 34, 39, 44, 54, and 60 have been amended; and claims 34-43 and 54-65 are currently under consideration for patentability.
Response to Arguments
Applicant’s arguments dated 27 August 2026 have been fully considered, but they are not persuasive or 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.
Applicant has amended the independent claims to recite wherein the first pacing routine is configured to determine that a first interval has passed without detection of a heartbeat following the at least one defibrillating shock, and apply, responsive to determining that the first interval has passed without detection of a heartbeat, pacing pulses via the plurality of therapy electrodes. The Examiner has introduced the Kramm reference to address the amended limitations in the updated text of the rejection below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 34-41, 43, and 54-65 are rejected under 35 U.S.C. 103 as being unpatentable over Donnelly et al. (US 2010/0298899 A1) in view of Kroll et al. (US 7,225,020 B1) and Kramm (US 5,766,225).
Regarding claims 34, 54, and 60, Donnelly describes a wearable cardioverter defibrillator, a method of treating arrhythmia, and a non-transitory computer readable medium ([0025]) for applying defibrillating shocks followed by pacing pulses ([0029], [0078]), the wearable cardioverter defibrillator comprising
a harness wearable about a torso of a patient ([0025])
a plurality of therapy electrodes attached to the harness and configured to apply at least one defibrillating shock to the patient ([0029])
a plurality of sensing electrodes attached to the harness and configured to acquire electrocardiographic signals indicative of cardiac activity of the patient ([0032])
a therapy delivery interface and associated circuitry ([0026], [0055])
a memory storing a plurality of pacing routines ([0012])
at least one processor coupled with the memory, the plurality of sensing electrodes, the therapy delivery interface, and the plurality of therapy electrodes ([0026]) and configured to
detect an arrhythmia through the ECG signals acquired via the plurality of sensing electrodes ([0049])
control, in response to detection of the arrhythmia, application of the at least one defibrillating shock via the therapy delivery interface and the plurality of therapy electrodes ([0050], [0054])
control, via execution of the first pacing routine, application of the plurality of pacing pulses subsequent to the application of the at least one defibrillating shock ([0055] - [0056], [0078])
Regarding claims 34, 54, and 60, although Donnelly describes delivering anti-arrhythmia pacing pulses in response to detection of an arrhythmia ([0054]), Donnelly does not explicitly disclose at least one first pacing routine of the plurality of pacing routines configured to control the WCD to apply a plurality of pacing pulses at an anti-tachyarrhythmic pacing rate and at least one second pacing routine of the plurality of pacing routines configured to control the WCD to apply a plurality of pacing pulses at a rate other than the anti-tachyarrhythmic pacing rate. However, Kroll also describes a cardioverter defibrillator (col 1:28-33), including the use of at least one first pacing routine configured to control the cardioverter defibrillator to apply a plurality of pacing pulses at an anti-tachyarrhythmic pacing rate and at least one second pacing routine configured to control the cardioverter defibrillator to apply a plurality of pacing pulses at a rate other than the anti-tachyarrhythmic pacing rate (col 2:39-50, use of therapeutic overdrive pacing, which represents one type of anti-tachycardia pacing; col 10:58-11:12). As Kroll is also directed towards use of a cardioverter defibrillator and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use an anti-tachyarrhythmic pacing rate similar to that described by Kroll when using the device described by Donnelly, as doing so advantageously allows the resulting device to provide a therapy that is known to have the beneficial effect of terminating the patient’s arrhythmia.
Regarding claims 34, 54, and 60, Donnelly also does not explicitly disclose wherein the first pacing routine is configured to determine that a first interval has passed without detection of a heartbeat following the at least one defibrillating shock, and apply, responsive to determining that the first interval has passed without detection of a heartbeat, pacing pulses via the plurality of therapy electrodes. However, Kramm also describes use of a cardioverter defibrillator (col 1:7-12) including wherein the system is configured to determine that an interval has passed without detection of a heartbeat and apply, responsive to determining that the first interval has passed without detection of a heartbeat, pacing pulses via a plurality of therapy electrodes (col 5:26-36). As Kramm is also directed towards use of a cardioverter defibrillator and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a pacing routine similar to that described by Kramm when using the device described by Donnelly, as doing so advantageously allows the resulting device to confirm that a pacing pulse is necessary, for example in the event that a heartbeat is not detected.
Regarding claims 35, 55, and 61, Kroll describes wherein the anti-tachyarrhythmic pacing rate is higher than an intrinsic rate of the patient (col 2:39-49).
Regarding claim 36, although neither Donnelly nor Kroll explicitly disclose wherein the plurality of pacing pulses number between 5 and 10 pacing pulses, Kroll does describe the use of a microcontroller in order to adjust the number, frequency, and energy of the pacing pulses (col 14:9-38, 3:6-35, use of burst pacing when necessary). Based at least on this, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure the device resulting from an obvious combination of the Donnelly and Kroll references such that it delivered between 5 and 10 pacing pulses, as doing so would be a matter of optimizing the exact number of pulses through routine experimentation (please see MPEP 2144.05).
Regarding claims 37, 39, 41, 56-58, and 62-64, Kroll describes wherein to control the application of the plurality of pacing pulses comprises to control application of pacing pulses at a fixed rate or a variable rate (col 14:9-38, providing synchronous or asynchronous delivery of pulses) and at a fixed energy level or a variable energy level (col 14:9-38, using low, moderate, or high energy shocking pulses).
Regarding claim 38, although neither Donnelly nor Kroll explicitly disclose wherein the fixed rate is between 30 pulses per minute and 200 pulses per minute and each pacing pulse of the plurality of pacing pulses has a width between 0.05 milliseconds and 2 milliseconds, Kroll does describe the use of a microcontroller in order to adjust the rate and duration of the pacing pulses (col 14:9-38). Based at least on this, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure the device resulting from an obvious combination of the Donnelly and Kroll references such that it delivered pulses at rate and pulse width similar to those recited, as doing so would be a matter of optimizing the pulse parameters through routine experimentation (please see MPEP 2144.05).
Regarding claim 40, Kroll describes wherein the variable rate depends on intrinsic cardiac activity of the patient (col 1:34-2:10).
Regarding claim 43, Donnelly describes wherein The arrhythmia comprises bradycardia ([0061]).
Regarding claims 59 and 65, Donnelly describes wherein identifying a pacing routine from a plurality of pacing routines comprises identifying a pacing routine from a plurality of pacing routines stored in a memory of the WCD ([0012]).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Donnelly in view of Kroll and Kramm, further in view of Kim et al. (US 2005/0149125 A1).
Regarding claim 42, Donnelly in view of Kroll and Kramm suggests the wearable cardioverter defibrillator of claim 41, including wherein the variable rate depends on intrinsic cardiac activity of the patient (Kroll, col 1:34-2:10), but Donnelly, Kroll, and Kramm do not explicitly disclose wherein the variable energy level depends on the intrinsic cardiac activity of the patient. However, Kim also describes a cardioverter defibrillator ([0003]), including wherein a variable energy level of pulses depends on the intrinsic cardiac activity of the patient ([0027]). As Kim is also directed towards use of a cardioverter defibrillator and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to adjust the energy level of pulses based on the intrinsic cardiac activity of the patient, in a manner similar to that described by Kim, when using the device described by Donnelly, Kroll, and Kramm, as doing so advantageously allows the resulting device to tailor the therapy to the patient’s individual intrinsic cardiac properties.
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Rodenhiser et al. (US 6,847,842 B1), which describes a wearable cardioverter defibrillator configured to provide defibrillating shocks and pacing pulses (col 2:17-34), including “delivering an atrial defibrillation shock without an accompanying second ventricular pacing pulse at a specified time after the first ventricular pacing pulse but inhibiting the atrial defibrillation shock if a second R wave subsequent to the first ventricular pacing pulse occurs before the specified time” (claim 1)
Pastore et al. (US 2003/0233132 A1), which describes a cardioverter defibrillator ([0002]) including details on properly timing or gating the pacing pulses ([0040], [0042])
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 Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Niketa Patel, can be reached by telephone at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3792
