DETAILED ACTION
1. This office action is in response to the communicated dated 25 June 2026 concerning application number 18/723,136 effectively filed on 21 June 2024.
Notice of Pre-AIA or AIA Status
2. 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 (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.
Status of Claims
3. Claims 1-24 are pending, of which claims 1, 9, 20, and 23-24 have been amended; and claims 1-24 are under consideration for patentability.
Response to Arguments
4. Applicant’s arguments dated 25 June 2026, referred to herein as “the Arguments”, have been fully considered, but they are not persuasive in view of the new grounds of rejection necessitated by Applicant’s amendments to the claims.
Applicant argues that Beyer does not explicitly teach the amended limitation that recites the energy storage system located as part of the pad. Specifically, Applicant emphasized that modifying the defibrillator in Beyer to relocate the energy storage component into the pads would require substantial redesign of the system and would not be a routine modification (pages 7-9 of the Arguments). The Examiner has introduced a secondary reference by Poore to address the amended limitation. However, the Examiner respectfully disagrees with Applicant’s argument which states that any modification to Beyer will cause a substantial redesign of the system. Specifically, Beyer illustrates a discharge circuit on figure 12 which indicates the defibrillation pads 1216a and 1216b being electrically coupled to the energy storage capacitors 1209a and 1209b [0125, FIG. 12]. The Examiner respectfully submits that Beyer teaches the discharge circuit to be part of the defibrillator unit ([0006, 0125]). In this case, the energy storage capacitors 1209a-1209b of the discharge circuit are located within the defibrillation unit and are electrically coupled with the defibrillation pads 1216a and 1216b ([0006, 0125, FIG. 12]). Thus, any further modification to Beyer to integrate the energy storage capacitors 1209a-1209b directly into the defibrillation pads 1216a-1216b would not require a substantial redesign of the system, as Beyer’s energy storage capacitors 1209a-1209b of the discharge circuitry are located within the defibrillation unit (see the explanation above). As stated previously above, the Examiner has introduced a secondary reference by Poore to modify Beyer’s energy storage system (e.g., energy storage capacitors) to be located as part of the pad.
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1-4, 7, 9-20, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Beyer et al. (US 2021/0093877 A1) in view of Poore et al. (US 2014/0277226 A1).
Regarding claim 1, Beyer teaches an automated external defibrillator (AED) comprising two pads for placement on a patient (the portable defibrillation unit 110 comprises a defibrillator controller 202 that is coupled to defibrillator pads 1216a and 1216b [abstract, 0039, 0084, 0125, FIG. 12]), each pad comprising an energy storage system (the defibrillation pads 1216a and 1216b comprises energy storage capacitors 1209a and 1209b that coupled to the defibrillator controller 202 [0084, 0119, 0124-0125, FIG. 12]);
the energy storage system comprising at least two energy storage blocks (the energy storage capacitors 1209a and 1209b are configured to store energy [0119, 0124-0125, 0186, FIG. 12]), a switching circuit and a shock generation circuit connected to the two pads (the switches 1223a-1223d and the discharge circuit are connected to defibrillator pads 1216a-1216b to deliver the defibrillation shock [0124-0126]), and a controller connected to the switching circuit and the shock generation circuit (the defibrillator controller 202 is connected to the switches 1223a-1223d and the discharge circuit [0124-0126]), the controller configured to perform an electrical switching operation to provide a defibrillation shock in two phases ([0125-0126]), such that the voltage and a peak current in each of the two phases is substantially the same (each phase may have approximately the same energy level and the waveforms have same current magnitude ([0122, 0125-0126, 0128]).
Beyer does not explicitly teach the energy storage system located as part of the pad.
The prior art by Poore is analogous to Beyer, as they both teach an external defibrillator comprising pads ([0047]).
Poore teaches the energy storage system located as part of the pad (the defibrillator 10 comprises the first pad 16 and the second pad 18 [0047]. Specifically, the first pad 16 may include an electrode 30 operatively connected to one or more energy storage capacitors 32 [0054, 0056]. The Examiner respectfully submits that the one or more energy storage capacitors 32 may be contained within the housing 24 of the first pad 16 [0054, 0056, FIG. 1, FIG. 2]. Furthermore, the second pad 18 may include an electrode 36 connected to one or more energy storage capacitors 38 [0055]. The Examiner further submits that the one or more energy storage capacitors 38 may be contained within the housing 24 of the second pad 18 [0055-0056, FIG. 1, FIG. 2]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Beyer’s energy storage system to be located as part of the pad, as taught by Poore. This modification is beneficial, as the housing of the pads may be easily accessed for maintenance and replacement of electrical parts, such as the energy storage capacitors or batteries (see paragraphs [0054-0056, 0069]).
Regarding claim 2, Beyer teaches wherein the at least two energy storage blocks are independent of each other for each of the two phases of the defibrillation shock (the capacitors 1209a and 1209b are electrically isolated from one another which allows the capacitors to be discharged separately during the two phases of the defibrillation shock [0124-0126, FIG. 12]).
Regarding claim 3, Beyer teaches wherein the at least two energy storage blocks are connected in parallel, each energy storage block comprising at least one capacitor (the controller 202 is coupled to the capacitors 1209a and 1209 having energy storage components that are connected or charged in parallel [0120, 0124, 0218]) and at least one of the energy storage blocks comprising two or more capacitors in series (the controller 202 may include additional capacitors that are connected in series and/or parallel [0123, 0218]).
Regarding claim 4, Beyer teaches wherein the series and parallel arrangement of the capacitors are the same during both charging of the energy storage blocks and discharging of the energy storage blocks to provide a defibrillation shock (the capacitors may be connected in series and/or parrel during charging and discharging to provide the defibrillation shock [0120, 0123-0124, 0218]).
Regarding claim 7, Beyer teaches the controller is further configured to generate a predetermined dosage of current for defibrillation shock at a predetermined dosage of power ([0060, 0086]).
Regarding claim 9, Beyer teaches wherein the controller is further configured to produce a fully tilted waveform for each of the two phases (figure 11A illustrates each of the phases having a tilted waveform [0122 FIG. 11A]).
Regarding claim 10, Beyer teaches wherein the switching circuit is configured to perform electrical switching operation such that one of the energy storage blocks is configured to charge, store and discharge to provide energy for one of the two phases (the controller 202 comprises a switch 1223a that is configured to operate the capacitor 1209a to charge, store, and discharge energy during one of the two phases [0125-0126, FIG. 12]), and the other of the energy storage blocks is configured to charge, store and discharge to provide energy for the other of the two phases of the defibrillation shock (the controller 202 comprises a switch 1223b that is configured to operate the capacitor 1209b to charge, store, and discharge energy during one of the two phases [0125-0126, FIG. 12]).
Regarding claim 11, Beyer teaches wherein the switching circuit is configured to perform electrical switching operation such that the direction of the current flow is maintained during each of the two phases during the defibrillation shock (the switches 1223a and 1223b may maintain the current in the same direction during each of the phases [0049, 0125-0126]. For example, the switches 1223a-1223b are coupled to the controller 202 which includes diodes 243 to prevent the current from flowing in the reverse direction during the phases [0049, 0125-0126, FIG. 12]).
Regarding claim 12, Beyer teaches wherein each of the capacitors of at least one of the energy storage blocks have the same or substantially the same nominal capacitance and working voltage (the capacitors may utilize the same amount of energy and/or voltage during the phase of the defibrillator shock [0121-0122, 0128]).
Regarding claim 13, Beyer teaches wherein each energy storage block further comprises any one or more of a balancing resistor ([0055]) or a diode ([0049]).
Regarding claim 14, Beyer teaches wherein the AED further comprises an electrical switch, wherein the electrical switch is configured to be operable in a low voltage or a low power mode (the controller 202 is coupled to an electrical switch (e.g., relay switch 229) which may operate in a low voltage mode for safety reasons [0109]).
Regarding claim 15, Beyer teaches wherein the shock generation circuit comprises a charging circuit and/or a discharging circuit configured to charge and/or discharge the one or more capacitors of the energy storage blocks ([0084, 0124-0126]).
Regarding claim 16, Beyer teaches wherein the controller is configured to operate the shock generation and switching circuit to automatically perform electrical measurement and stimulation of the patient's heart switching between the two phases (the controller 202 is configured to control the state of relay 229 and to switch the various components of the defibrillator between the ECG reading and discharge states [0047, 0107]. Furthermore, the controller 202 is configured to switch between the first phase and the second phase of the defibrillation shock [0011, 0047, 0122, 0125-0126]).
Regarding claim 17, Beyer teaches wherein each of the two pads comprises one or more electrodes, and wherein the at least one electrode of each pad is configured to carry out at least one of an electrical measurement and stimulation of the patient's heart (the controller 202 is coupled to electrode pads which provide ECG sensing and stimulation to the patient’s heart [0041, 0047]).
Regarding claim 18, Beyer in view of Poore suggests the AED of claim 1. Beyer teaches wherein one of the energy storage blocks is configured to charge, store and discharge to provide energy for the first of the two phases (the controller 202 comprises a switch 1223a that is configured to operate the capacitor 1209a to charge, store, and discharge energy during one of the two phases [0125-0126, FIG. 12]), and the other of the energy storage blocks is configured to charge, store and discharge to provide energy for the second of the two phases of the defibrillation shock (the controller 202 comprises a switch 1223b that is configured to operate the capacitor 1209b to charge, store, and discharge energy during one of the two phases [0125-0126, FIG. 12]).
However, Beyer does not explicitly teach wherein the energy storage system comprises at least six energy storage blocks, and wherein four energy storage blocks are configured to charge, store and discharge to provide energy for the first of the two phases of the defibrillation shock, and wherein the other two energy storage blocks are configured to charge, store and discharge to provide energy for the second of the two phases of the defibrillation shock.
The Examiner respectfully submits that Beyer teaches the use of energy storage blocks that are configured to charge, store, and discharge to provide energy during the two phases ([see Beyers teachings above]). Thus, configuring the exact number of energy storage blocks that are used during each of the two phases would be a matter of duplicating the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 19, Beyer teaches wherein the at least two energy storage blocks are connected are connected in parallel, each energy storage block comprising at least one capacitor ([0120, 0124, 0218]).
Regarding claim 20, Beyer teaches a method of operating an AED having two pads for placement on a patient ([0047]), each pad comprising an energy storage system (the defibrillation pads 1216a and 1216b comprises energy storage capacitors 1209a and 1209b that coupled to the defibrillator controller 202 [0084, 0119, 0124-0125, FIG. 12]), the AED further comprising a switching circuit and a shock generation circuit connected to the two pads (the switches 1223a-1223d and the discharge circuit are connected to defibrillator pads 1216a-1216b to deliver the defibrillation shock [0124-0126]), and a controller connected to the switching circuit and the shock generation circuit (the defibrillator controller 202 is connected to the switches 1223a-1223d and the discharge circuit [0124-0126]), the method comprising:
performing multiple functions of electrical measurement and stimulation of the patient's heart ([0047]), and
operating the controller to perform an electrical switching operation to provide a defibrillation shock in two phases ([0122, 0125-0126, 0128]), wherein a voltage and a peak current in each of the two phases is substantially the same (each phase may have approximately the same energy level and the waveforms have same current magnitude ([0122, 0125-0126, 0128]).
Beyer does not explicitly teach the energy storage system located as part of the pad.
The prior art by Poore is analogous to Beyer, as they both teach an external defibrillator comprising pads ([0047]).
Poore teaches the energy storage system located as part of the pad (the defibrillator 10 comprises the first pad 16 and the second pad 18 [0047]. Specifically, the first pad 16 may include an electrode 30 operatively connected to one or more energy storage capacitors 32 [0054, 0056]. The Examiner respectfully submits that the one or more energy storage capacitors 32 may be contained within the housing 24 of the first pad 16 [0054, 0056, FIG. 1, FIG. 2]. Furthermore, the second pad 18 may include an electrode 36 connected to one or more energy storage capacitors 38 [0055]. The Examiner further submits that the one or more energy storage capacitors 38 may be contained within the housing 24 of the second pad 18 [0055-0056, FIG. 1, FIG. 2]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Beyer’s energy storage system to be located as part of the pad, as taught by Poore. This modification is beneficial, as the housing of the pads may be easily accessed for maintenance and replacement of electrical parts, such as the energy storage capacitors or batteries (see paragraphs [0054-0056, 0069]).
Regarding claim 23, Beyer teaches wherein the multiple functions of electrical measurement and stimulation of the patient's heart performed by the one or more electrodes in multiple directions ([0047, 0107]) comprise:
measuring cardiac electrical signals to detect locations of the two pads ([0047, 0107, 0185-0186]);
measuring ECG signals to detect shockable cardiac rhythms ([0047, 0107, 0185-0186]); and
delivering doses of defibrillation shocks by the two pads based on their detected locations when shockable cardiac rhythms are detected ([0047, 0107, 0185-0186]).
Regarding claim 24, Beyer teaches wherein the measured cardiac electrical signals used to detect locations of the two pads comprise impedance ([0128, 0185]).
7. Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Beyer et al. in view of Poore et al., further in view of Savage et al. (US 2019/0192867 A1).
Regarding claim 5, Beyer in view of Poore suggests the AED of claim 1. Beyer and Poore do not explicitly teach wherein each pad has a volume of about 100 cm3 to 200 cm3, and a surface area of about 50 cm2 to 100 cm2.
The prior art by Savage is analogous to Beyer, as they both teach the use of defibrillator.
Savage teaches wherein each pad has a volume of less than 550 cm3 ([0062]).
Savage does not explicitly teach wherein each pad has a volume of about 100 cm3 to 200 cm3, and a surface area of about 50 cm2 to 100 cm2.
However, the Examiner respectfully submits that Savage teaches that the overall size of the pads may be configured to be less than 550 cm3. Therefore, a person having ordinary skill in the art would have found it obvious to configure each pad to have a volume of about 100 cm3 to 200 cm3, and a surface area of about 50 cm2 to 100 cm2. The advantage of such modification may improve the delivery of the shocks through the defibrillator (see paragraph [0062]) by Savage). The Examiner further submits that the skilled artisan could arrive at the claimed ranges via routine experimentation (MPEP 2144.05).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the pads suggested by Beyer in view of Poore to have a volume of about 100 cm3 to 200 cm3 and a surface area of about 50 cm2 to 100 cm2, as suggested by Savage. The advantage of such modification may improve the delivery of the shocks through the defibrillator (see paragraph [0062]) by Savage).
Regarding claim 6, Beyer in view of Poore suggests the AED of claim 1. Beyer and Poore do not explicitly teach wherein the controller is further configured to produce an equal leading edge waveform for each of the two phases.
However, Savage teaches wherein the controller is further configured to produce an equal leading edge waveform for each of the two phases (the magnitude of the positive and negative phases of the waveform are equal in starting amplitude [0124, FIG. 17B]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the controller suggested by Beyer in view of Poore to comprise produce an equal leading edge waveform for each of the two phases, as taught by Savage. The advantage of such modification may improve the effectiveness of the defibrillation shock treatment (see paragraph [0124] by Savage).
8. Claims 8 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Beyer et al. in view of Poore et al., further in view of Shao (US 2012/0158073 A1).
Regarding claim 8, Beyer in view of Poore suggests the AED of claim 1. Beyer and Poore do not explicitly teach wherein the controller is further configured to maintain peak current in each phase such that the polarization effect is observed in the first phase and a depolarization effect is achieved in the second phase.
The prior art by Shao is analogous to Beyer, as they both teach the use of a defibrillator that delivers biphasic pulses to the patient ([abstract, 0016]).
Shao teaches wherein the controller is further configured to maintain peak current in each phase such that the polarization effect is observed in the first phase and a depolarization effect is achieved in the second phase ([0013, 0017, 0028]).
Therefore, it would have been obvious to a person having ordinary skill in the art to modify the controller suggested by Beyer in view of Poore to maintain a peak current in each phase such that the polarization effect is observed in the first phase and a depolarization effect is achieved in the second phase, as taught by Shao. The advantage of such modification will enhance the defibrillation treatment to the heart (see paragraphs [0013, 0017, 0028] by Shao).
Regarding claim 21, Beyer in view of Poore suggests the method of claim 20. Beyer and Poore do not explicitly teach wherein the peak current and voltage in the first of the two phases of the defibrillation shock are maintained until a first time interval in which a polarization effect is observed in the patient
The prior art by Shao is analogous to Beyer, as they both teach the use of a defibrillator that delivers biphasic pulses to the patient ([abstract, 0016]).
Shao teaches wherein the peak current and voltage in the first of the two phases of the defibrillation shock are maintained until a first time interval in which a polarization effect is observed in the patient ([0013, 0016-0017]).
Therefore, it would have been obvious to a person having ordinary skill in the art to modify the controller suggested by Beyer in view of Poore to maintain a peak current in each phase such that the polarization effect is observed in the first phase and a depolarization effect is achieved in the second phase, as taught by Shao. The advantage of such modification will enhance the defibrillation treatment to the heart (see paragraphs [0013, 0017, 0028] by Shao).
Regarding claim 22, Beyer in view of Poore and Shao suggests the method of claim 21. Shao teaches wherein the first time interval is the time taken for the defibrillation shock to reach all cells of myocardium of the patient (the Examiner respectfully submits that the “polarization effect” is a known process which affect the cells of myocardium when the heart is shocked [0013, 0017]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the defibrillator suggested by Beyer in view of Poore and Shao to deliver a shock within the first time interval that reaches all cells of the myocardium, as further taught by Shao. The advantage of such modification will allow for providing first phase pulse that causes a polarization effect to the heart cells and a second phase pulse that depolarizes the heart cells to provide a better treatment (see paragraphs [0013, 0017] by Shao).
Conclusion
9. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The prior art by Kumar (US 2017/0056682 A1) is pertinent to Applicant’s disclosure, as Kumar teaches an external defibrillator comprising a first and second pad ([abstract]).
10. 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 JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
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