DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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.
Information Disclosure Statement
2. The Information Disclosure Statement filed on 21 June 2024 has been considered by the Examiner.
Claim Rejections - 35 USC § 102
3. 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.
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.
4. Claims 1-4, 7, 9-17, 19-20, and 23 are rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by Beyer et al. (US 2021/0093877 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 ([0124-0126]), and a controller connected to the switching circuit and the shock generation 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]) .
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 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]), the method comprising:
performing multiple functions of electrical measurement and stimulation of the patient's heart ([0047]), and operating a 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 ([0122, 0128]).
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]).
Claim Rejections - 35 USC § 103
5. 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.
6. Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Beyer et al. in view of Savage et al. (US 20190192867 A1).
Regarding claim 5, Beyer teaches the AED of claim 1. Beyer 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.
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 Beyer’s pads 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, 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]).
7. Claims 8 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Beyer et al. in view of Shao (US 2012/0158073 A1).
Regarding claim 8, Byer teaches the AED of claim 1. Beyer does 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 Beyer’s controller 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]).
Regarding claim 21, Beyer teaches the method of claim 20. Beyer does 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 Beyer’s controller 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]).
Regarding claim 22, 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]).
8. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Beyer et al.
Regarding claim 18, Beyer teaches the AED of claim 1, 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).
Statement on Communication via Internet
9. Communications via Internet email are at the discretion of the applicant. All Internet communications between USPTO employees and applicants must be made using USPTO tools.
Without a written authorization by applicant in place, the USPTO will not respond via Internet email to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. A paper copy of such correspondence and response will be placed in the appropriate patent application. Except for correspondence that only sets up an interview time, all correspondence between the Office and the applicant including applicant's representative must be placed in the appropriate patent application. If an email contains any information beyond scheduling an interview such as an interview agenda or authorization, it must be placed in the application.
For those applications where applicant wishes to communicate with the examiner via Internet communications, e.g., email or video conferencing tools, 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
10. 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.
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 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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/J.B.S./Examiner, Art Unit 3792
/ANKIT D TEJANI/Primary Examiner, Art Unit 3796