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 Preliminary Amendment
This Office Action is responsive to the amendment filed on 01 May 2026. As directed by the amendment: claims 1, 5, 7, 9-10, and 20 have been amended, no claims have been canceled, and no claims have been added. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Claim Objections
Applicant's arguments filed 01 May 2026 have been fully considered but they are not persuasive.
Claims 9 and 10 are substantial duplicates, as explained below. Neither claim 9 nor claim 10 was canceled in the amendment filed 01 May 2026. Therefore, the objection to claim 10 is maintained.
New objections are also made below.
Rejections Under 35 U.S.C. § 112(b)
Applicant’s arguments, see Remarks, filed 01 May 2026, with respect to the rejections of claims 7 and 9-13 under 35 U.S.C. 112(b) have been fully considered and are persuasive in light of the claim amendments. The rejections of claims 7 and 9-13 under 35 U.S.C. 112(b) have been withdrawn.
Rejections under 35 U.S.C. § 103(a) over Barkley, in view of Bucher
Applicant’s arguments, see Remarks, filed 01 May 2026, with respect to the rejection of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Vaisnys et al. (US 7,495,413, hereinafter Vaisnys) and Manicka (US 2020/0038649), as explained in further detail below.
No specific arguments were made regarding dependent claims 2-20 and the previously cited prior art references. Therefore, dependent claims 2-20 are also rejected below.
Specification
The disclosure is objected to because of the following informalities: the first paragraph should list all parent applications found in the ADS filed on 29 Aug 2025 and their current status.
Appropriate correction is required.
Claim Objections
Claims 6-7, 12 and 17 are objected to because of the following informalities:
Claim 6: “the microcontroller” in line 1 should read “the microcontroller control unit” in alignment with the term established in parent claim 1.
Claim 7: “the microcontroller” in lines 1-2 should read “the microcontroller control unit” in alignment with the term established in parent claim 1.
Claim 12: “the microcontroller control unit further configured” in lines 2-3 should read “the microcontroller control unit is further configured”
Claim 17: “further” in line 1 should read “wherein”
Appropriate correction is required.
Claim 10 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 9. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
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.
Claims 1-5, 8-10, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Barkley et al. (US 5868794, previously cited) (hereinafter Barkley) in view of Bucher (US 2006/0111748, previously cited), Vaisnys et al. (US 7,495,413, hereinafter Vaisnys) and Manicka (US 2020/0038649).
Regarding claim 1, Barkley discloses a defibrillation assembly energizable through case opening (Fig. 1-3; Col. 3-4, ll. 65-38; Col. 5, ll. 6-16), comprising:
a magnetically-activated reed switch (lid switch 25; Col. 3, ll. 15-17);
an energy storage element that supplies power to the magnetically-activated reed switch (battery pack 16);
circuitry configured to generate one or more defibrillation waveforms, wherein flow of the power to the circuitry from the energy storage element is dependent on a position of the magnetically-activated reed switch (Col. 3-4, ll. 65-38; Col. 5, ll. 6-16); and
a case within which at least a portion of the circuitry is located (plastic case 12), the case comprising a cover (lid 27) and an electrode enclosure within which electrode pads for delivery of the defibrillation waveforms are stored (electrode compartment 26), and wherein an opening of the case that comprises a removal of the cover causes a change in the position of the magnetically-activated reed switch and the power to flow to the circuitry (Fig. 2 depicts device with lid open; Col. 3, ll. 15-17; Col. 5, ll. 6-16).
Barkley does not disclose a magnet is one of positioned on the cover and embedded within the cover.
Bucher, however, teaches a defibrillator (Abstract) wherein a sensor device is advantageously provided, by which the defibrillator 1 is switched on as soon as the lid-like cover 3 is removed from the housing 2. For example, the sensor device has a magnetically or opto-electrically or electro-mechanically functioning switching device, wherein a sensor element 8.1, for example a permanent magnet or optically acting element or mechanical triggering element, arranged on the cover 3 acts together with a sensor element 8.2, for example a magnetic field sensor element, a photo-electrically reacting sensor element or a mechanically activable switch or key, arranged on a corresponding housing location, as shown in FIGS. 3 and 4C. Thus, a separate on/off switch can be omitted and the device is ready for triggering the defibrillation pulse after the electrodes are correctly placed (para. 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Barkley such that a magnet is one of positioned on the cover and embedded within the cover. Making this modification would be useful such that a separate on/off switch can be omitted and the device is ready for triggering the defibrillation pulse after the electrodes are correctly placed, as taught by Bucher.
Neither Barkley nor Bucher explicitly discloses that the microcontroller control unit is electrically unbiased when the power is not flowing to the circuitry.
However, Vaisnys teaches a Semi-Automatic External Defibrillator ("AED") (Fig. 1A, column 2, lines 6-7). An energy storage element 410 supplies power to an electromechanical switch 510, such that defibrillation circuitry 505 (i.e., “circuitry configured to generate a defibrillation waveform”) is isolated from the energy storage element by the electromechanical switch 510 being in an open position when the circuitry is not in use (Col. 3, lines 13-21 and Col. 4, lines 3-30).
Vaisnys does not disclose a microcontroller control element as being part of circuitry 505, but instead discloses the use of a DSP 562.
However, it is well known within the medical arts that a DSP is an equivalent structure to a microcontroller. Attention is directed to Manicka, which discloses a defibrillator, and thus is analogous art to Vaisnys (see abstract). Manicka further discloses that a DSP is functionally equivalent to a microcontroller for implementing functionality and/or processing instructions within the defibrillator (par. 0138).
Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Vaisnys to utilize a microcontroller in place of the DSP as Manicka teaches such a replacement would be a functional equivalent. In doing so, the circuitry 505 of Vaisnys would include a microcontroller that is electrically unbiased when the power is not flowing from the energy storage element 410, as described above.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Barkley with the teachings of Vaisnys so that the microcontroller control unit is electrically unbiased when the power is not flowing to the circuitry, because doing so prevents the energy storage element from being drained when the AED is powered off (Vaisnys, Col. 3, lines 19-21).
Regarding claim 2, Barkley discloses the cover has a rectangular shape (Fig. 2 depicts rectangular shape of lid 27).
Regarding claim 3, Barkley discloses the cover comprises one or more of rigid plastic, flexible plastic (Col. 2, ll. 48 discloses the case 12 is made of plastic, which would be either rigid or flexible by definition).
Regarding claim 4, Barkley discloses the electrode enclosure comprises a rectangular shape (Fig. 2 depicts rectangular shape of electrode compartment 26).
Regarding claim 5, Barkley discloses a microcontroller control unit configured to receive the power upon the opening of the case (Col. 3, ll. 31-40) and to analyze a time during which the flow of the power continues (Col. 5, ll. 17-40).
Regarding claim 8, Barkley discloses the microcontroller control unit further configured to conduct a power-on self-test after the receipt of the power (Col. 5, ll. 17-40).
Regarding claims 9-10, Barkley discloses the microcontroller control unit further configured to determine a state of the electrode pads following a successful completion of the power-on self-test (Col. 5, ll. 17-20 discloses checking the interconnection and operability of electrodes 50).
Regarding claim 17, Barkley discloses the cover is removably affixed to one or more walls comprises in the case (Fig. 1-3 depict how lid 27 is removably affixed to walls of electrode enclosure 26).
Regarding claim 18, Barkley discloses the walls form the electrode enclosure (Fig. 2, walls defined by electrode enclosure 26).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over modified Barkley in view of Axness (US 10238881, previously cited).
Regarding claims 6-7, modified Barkley does not teach the microcontroller further configured to determine the opening of the case accidental based on the analyzed time, the microcontroller further configured to cause a discharge and powering down of the circuitry upon the determination that the opening of the case was accidental.
Axness, however, teaches a defibrillator (Abstract) wherein in operation, the automatic power on circuit senses a case opening, and sends an activation signal to controller 206. Controller 206 in turn retrieves data of previous activation events from memory 230. If the previous events combined with the present activation indicate that the activation is the latest in a pattern of events that indicates a repeated inadvertent activation, then controller 206 disables the automatic power on circuit and returns the defibrillator to a standby condition. Return to standby may occur after the timeout period has passed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Barkley such that the microcontroller further configured to determine the opening of the case accidental based on the analyzed time, the microcontroller further configured to cause a discharge and powering down of the circuitry upon the determination that the opening of the case was accidental. Making this modification would be useful for conserving power if the device was activated inadvertently, as taught by Axness.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over modified Barkley in view of Picardo et al. (US 7016726, previously cited) (hereinafter Picardo).
Regarding claims 11-12, modified Barkley does not teach upon the determination that the state of the electrode pads is that the pads have been applied to a patient, the microcontroller control unit is configured to determine whether a shockable rhythm is present in the patient, wherein upon the determination that the shockable rhythm is present, the microcontroller control unit further configured to control the generation of one or more of the defibrillation waveforms for delivery through the electrode pads.
Picardo, however, teaches a defibrillator (Fig. 3), wherein a defibrillator system is also provided. The defibrillator system comprises: at least one electrode pad having an electrode pad type operable to contact a patient; a medical electrode connector, connected to the defibrillator electrode pad on one end and the defibrillator on the other end, operable to identify the electrode pad type to the defibrillator; a front-end circuit operation to be coupled to the electrode pad and to receive identification information from the electrode pad; a shock delivery circuit coupled to the electrode pad; and a processor coupled to the front-end and shock delivery circuits and operable to determine whether the patient is experiencing a shockable heart condition and to enable the shock-delivery circuit to deliver a shock to the patient via the electrode pads if the processor determines that the patient is experiencing a shockable heart condition (Col. 2, ll. 22-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Barkley such that upon the determination that the state of the electrode pads is that the pads have been applied to a patient, the microcontroller control unit is configured to determine whether a shockable rhythm is present in the patient, wherein upon the determination that the shockable rhythm is present, the microcontroller control unit further configured to control the generation of one or more of the defibrillation waveforms for delivery through the electrode pads. Making this modification would be useful for treating a shockable heart condition, as taught by Picardo.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over modified Barkley in view of Picardo, further in view of Sullivan et al. (US 2022/0193405, previously cited) (hereinafter Sullivan).
Regarding claim 13, modified Barkley in view of Picardo does not teach a user interface through which a warning is delivered prior to the delivery of the one or more defibrillation waveforms.
Sullivan, however, teaches a defibrillator 200 may include a user interface (UI) 280 for a user 282 (para. 41). The user interface 280 may further include input devices for receiving inputs from users. Such users can be the patient 82, perhaps a local trained caregiver or a bystander, and so on. Such input devices may include various controls, such as pushbuttons, keyboards, touchscreens, one or more microphones, and so on. An input device can be a cancel switch, which is sometimes called an “I am alive” switch or “live man” switch. In some embodiments, actuating the cancel switch can prevent the impending delivery of a shock, or of pacing pulses. In particular, in some embodiments the speaker is configured to output a warning prompt prior to an impending or planned defibrillation shock or a pacing sequence of pacing pulses being caused to be delivered, and the cancel switch is configured to be actuated by the ambulatory patient 82 in response the warning prompt being output (para. 43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Barkley in view of Picardo such to include a user interface through which a warning is delivered prior to the delivery of the one or more defibrillation waveforms. Making this modification would be useful for facilitating a cancellation of the impending defibrillation shock, as taught by Sullivan.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over modified Barkley in view of SDM Magnetics (“What Are Permanent Ferrite Magnets”, https://www.youtube.com/watch?v=sEMuTMV59o0&t=1s, previously cited).
Regarding claims 14-15, modified Barkley does not teach the magnet is a ceramic magnet, wherein the magnet comprises ferrite. Examiner notes that ferrite is an example of a ceramic magnetic material, see Wikipedia article for “Ferrite (magnet)”.
SDM Magnetics, however, teaches that permanent ferrite magnets are the least expensive class of permanent magnet materials (0:08), have high resistance to corrosion and wider temperature range (0:15), and are available in different shapes according to need (0:26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Barkley such that the magnet is a ceramic magnet, wherein the magnet comprises ferrite. Making this modification would be useful for providing a magnetic material which is low cost, has high resistance to corrosion, wider temperature range, and available in different shapes according to need, as taught by SDM Magnetics.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over modified Barkley in view of Satsu et al. (US 7914695, previously cited) (hereinafter Satsu).
Regarding claim 16, modified Barkley does not teach the magnet comprises a binding agent and a magnetic material. Satsu, however, teaches the object of the present invention is to both reduce costs and improve magnetic characteristics of rare-earth bond magnets in which magnetic material is bound with a binding agent. In order to achieve this object, magnetic characteristics of a magnet are improved by performing cold forming on rare-earth magnetic powder by itself with no resin added. Then, in order to provide strength for the magnet, a low-viscosity SiO.sub.2 precursor is infiltrated and thermoset in the magnet shaped body. As a result, it is possible to obtain a rare-earth bond magnet in which magnetic characteristics are improved and costs are reduced (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Barkley such that the magnet comprises a binding agent and a magnetic material. Making this modification would be useful for providing a rare-earth bond magnet in which magnetic characteristics are improved and costs are reduced, as taught by Satsu.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over modified Barkley in view of Locke et al. (US 2003/0208237, previously cited) (hereinafter Locke).
Regarding claim 19, modified Barkley does not teach the flow of the power is interrupted upon a closing of the case.
Locke, however, teaches an AED (Abstract) wherein referring additionally to FIG. 3, the fully automatic external defibrillator 60 includes an on/off circuit 71 including a sensor switch 72 that is configured and arranged to sense the position of the lid 64 as opened or closed. The switch 72 is actuated when the lid is opened or closed, to thereby complete the on/off circuit 71, which in turn, under the control of the controller 22, activates or deactivates the fully automatic external defibrillator 60 based on the detected position of the lid 64. For example, in one embodiment, the on/off circuit 71 is configured to activate the fully automatic external defibrillator 60 when the switch 72 detects the lid 64 is opened, and to deactivate the defibrillator 60 when the switch 72 detects the lid 64 is closed. Sample lid switches suitable for use in the present embodiment include a relay switch such as a magnetic reed relay switch, a Hall-effect sensor switch, and any other electro/mechanical-type, magnet/mechanical-type, semiconductor-type, or optical-type switches known in the art (para. 40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Barkley such that the flow of the power is interrupted upon a closing of the case. Making this modification would be useful for deactivating the AED when the lid is closed, as taught by Locke.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over modified Barkley in view of Walker et al. (US 2004/0111124, previously cited) (hereinafter Walker).
Regarding claim 20, modified Barkley teaches a microcontroller control unit (see rejection of claim 5 above). Modified Barkley does not teach the control unit is configured to obtain patient impedance and to adjust one or more parameters of one or more of the defibrillation waveforms based on the patient impedance.
Walker, however, teaches selecting electrotherapy dosage (Abstract) wherein FIG. 4 is a graph illustrating example functions that describe relationships between voltage level adjustment and transthoracic impedance. The functions illustrated may be used by processor 26 of defibrillator 10 to adjust a nominal voltage level based on a measured transthoracic impedance of patient 12. Curves 60 and 62 are graphical depictions of equations that describe voltage level adjustment as a function of transthoracic impedance (para. 54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Barkley such that the control unit is configured to obtain patient impedance and to adjust one or more parameters of one or more of the defibrillation waveforms based on the patient impedance. Making this modification would be useful for adjusting voltage level of a defibrillator based on transthoracic impedance of a patient, as taught by Walker.
Conclusion
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 CHRISTINE SISON whose telephone number is (703)756-4661. The examiner can normally be reached 8 am - 5 pm PT, Mon - Fri.
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, 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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/CHRISTINE SISON/Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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