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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18/726,966, filed on 07/05/2024.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Dascoli et al. (hereinafter “Dascoli”) (U.S. Pub. No. 2017/0252571 A1) in view of Chapman et al. (hereinafter “Chapman”) (U.S. Pub. No. 2022/0193431 A1) and Kaib et al. (hereinafter “Kaib”) (U.S. Pub. No. 2016/0328529 A1).
Regarding claim 1, Dascoli teaches an automated external defibrillator (Abstract, where “This document describes an automated external defibrillator”) configured to deliver an electric shock for defibrillation to a heart of a subject (¶[0005], where “the automated external defibrillator delivers a defibrillating shock to a patient based on the mode-specific energy configuration,” ¶[0051], where “The sensing pulse is followed by a biphasic defibrillation waveform having energy sufficient for defibrillating the patient's heart”), the automated external defibrillator comprising:
a sound generator (¶[0030], where “The AED 100 includes a speaker 140. The speaker 140 can provide auditory instructions and/or other feedback to a user during treatment,” ¶[0069], where “The user interface of the AED 100 may include a speaker 140. The speaker 140 can provide audio instructions and feedback to the user during treatment. The speaker 140 can provide audio of the instructions which are displayed on the screen so that the user does not have to read the display”) configured to output:
a timing sound expressing, by sound, a timing until the electric shock is delivered (¶[0069], where “The speaker 140 can provide audio of the instructions which are displayed on the screen so that the user does not have to read the display,” ¶[0120], where “FIG. 10A shows an example of an instruction 1000 displayed if an electric shock is recommended. The instruction can be shown on the display 120 and can include … auditory instructions … the instruction 1000 is skipped and the AED can automatically begin a countdown to electric shock.” Examiner interprets that the auditory instruction of display 120 is emitted from speaker 140 since speaker 140 provides audio of instructions displayed on the screen, which is display 120.).
Although Dascoli teaches capacitors to store charge for delivering voltage (¶[0052], where “FIG. 1C shows an illustrative embodiment of basic circuitry 102 for producing a suitable biphasic waveform. A storage capacitor 20 (e.g., a single capacitor or multiple capacitors connected in series and/or parallel) may be charged to a maximum voltage”) and a speaker that can provide auditory instructions and/or other feedback to a user during treatment
(¶[0030]), Dascoli does not explicitly teach a warning sound expressing a state in which an internal capacitor of the automated external defibrillator has been charged with high voltage; nor a sound controller configured to control the sound generator, wherein the sound controller changes the warning sound in accordance with presence or absence of output of the timing sound.
Chapman teaches defibrillators with enhanced functionality during cardiopulmonary resuscitation (CPR) periods (Abstract), and further teaches a warning sound expressing a state in which an internal capacitor of the automated external defibrillator has been charged with high voltage (¶[0036], where “the portable defibrillator 106 outputs a signal indicating that the capacitor 126 is shock charged … An audio signal indicating that the capacitor 126 is charged may also be used alone or in combination with other indicators.”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Chapman, which teaches a warning sound expressing a state in which an internal capacitor of the automated external defibrillator has been charged with high voltage, with the invention of Dascoli in order to indicate that the capacitor is charged (Chapman ¶[0036]).
Although Dascoli teaches capacitors to store charge for delivering voltage (¶[0052]) and a speaker that can provide auditory instructions and/or other feedback to a user during treatment (¶[0030]), and Chapman teaches an audio signal that can be used in combination with other indicators (¶[0036], where “An audio signal indicating that the capacitor 126 is charged may also be used alone or in combination with other indicators”), neither Dascoli nor Chapman explicitly teach a sound controller configured to control the sound generator, wherein the sound controller changes the warning sound in accordance with presence or absence of output of the timing sound.
Kaib teaches a wearable medical device controller that is applicable to a wearable defibrillator (Abstract, ¶[0062], where “a wearable defibrillator may include the wearable medical device controller 100 to provide adaptive alarm functionality”), and further teaches a sound controller configured to control the sound generator (¶[0126], where “a microphone associated with the speaker assembly 714 detects a background noise level (i.e., background sound pressure level), and, in cooperation with a processor, enables adaptation of a sound pressure level of an alarm (or other acoustic output) according to an urgency of the alarm”),
wherein the sound controller changes the warning sound in accordance with presence or absence of output of the timing sound (¶[0126], where “more urgent alarms can have greater volumes that lower priority alarms.” Examiner interprets that the countdown to an electric shock is a more urgent event such that it will be prioritized over the warning sound and consequently set to a greater volume than the warning sound when both are emitted at the same time.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Kaib, which teaches a sound controller configured to control the sound generator, wherein the sound controller changes the warning sound in accordance with presence or absence of output of the timing sound, with the modified invention of Dascoli in order to prioritize more urgent alarms (Kaib ¶[0126]).
Regarding claim 2, Dascoli in combination with Chapman and Kaib teaches all limitations of claim 1 as described in the rejection above.
Kaib teaches that the sound controller changes at least one of volume, scale, and tone of the warning sound in accordance with presence or absence of output of the timing sound (¶[0126], where “more urgent alarms can have greater volumes that lower priority alarms.” Examiner interprets that the countdown to an electric shock is a more urgent event such that it will be prioritized over the warning sound and consequently set to a greater volume than the warning sound when both are emitted at the same time.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Kaib, which teaches that the sound controller changes at least one of volume of the warning sound in accordance with presence or absence of output of the timing sound, with the modified invention of Dascoli in order to prioritize more urgent alarms (Kaib ¶[0126]).
Regarding claim 3, Dascoli in combination with Chapman and Kaib teaches all limitations of claim 2 as described in the rejection above.
Kaib teaches that the sound controller sets the volume of the warning sound during output of the timing sound to a level lower than the volume of the warning sound during non-output of the timing sound (¶[0126], where “more urgent alarms can have greater volumes that lower priority alarms.” Examiner interprets that the countdown to an electric shock is a more urgent event such that it will be prioritized over the warning sound and consequently set to a greater volume than the warning sound when both are emitted at the same time.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Kaib, which teaches that the sound controller sets the volume of the warning sound during output of the timing sound to a level lower than the volume of the warning sound during non-output of the timing sound, with the modified invention of Dascoli in order to prioritize more urgent alarms (Kaib ¶[0126]).
Regarding claim 4, Dascoli in combination with Chapman and Kaib teaches all limitations of claim 2 as described in the rejection above.
Kaib teaches that the sound controller sets the scale of the warning sound during output of the timing sound to a level lower than the scale of the warning sound during non-output of the timing sound (¶[0102], where “the alarm manager issues the audio alarms according to the frequency, amplitude and tonal settings when the audio alarms are triggered by an event,” ¶[0115], where “speaker assembly includes a speaker and an acoustic resonator that, when used in combination, is configured to alter amplitudes of an acoustic output (e.g., an adaptive alarm as described above) at selected frequencies,” ¶[0120], where “As noted above, to alter the intensity, volume, or other characteristics of an audible output such as an alarm, one or more frequencies associated with the audible output can be adapted based upon various factors … a frequency of a first instance of an audible output such as an alarm can be selected such that the acoustic resonator does not amplify the volume and intensity output, thereby resulting in the alarm being output at a first volume level. As the alarm is adapted to the second instance, the frequency can be adapted such that the acoustic resonator can amplify the volume and intensity of the alarm, thereby resulting in the alarm being output at a second volume level that is higher than the first volume level,” ¶[0126], where “a microphone associated with the speaker assembly 714 detects a background noise level (i.e., background sound pressure level), and, in cooperation with a processor, enables adaptation of a sound pressure level of an alarm (or other acoustic output) according to an urgency of the alarm … more urgent alarms can have greater volumes that lower priority alarms.” Examiner interprets that scale of a sound correlates to frequency and amplitude of the sound. Furthermore, since the volume increase correlates to the frequency and amplitude changes, where an amplitude increase will increase volume, the more urgent sound will have a larger amplitude, and consequently, scale. Additionally, the countdown to an electric shock is a more urgent event such that it will be prioritized over the warning sound and consequently set to a greater volume, and thus scale, than the warning sound when both are emitted at the same time.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Kaib, which teaches that the sound controller sets the scale of the warning sound during output of the timing sound to a level lower than the scale of the warning sound during non-output of the timing sound, with the modified invention of Dascoli in order to enable the alarms to be perceived by the intended recipients with partial hearing loss (Kaib ¶[0102]) and to prioritize more urgent alarms (Kaib ¶[0126]).
Regarding claim 5, Dascoli in combination with Chapman and Kaib teaches all limitations of claim 2 as described in the rejection above.
Kaib teaches that the sound controller makes the tone of the warning sound during output of the timing sound different from the tone of the warning sound during non-output of the timing sound (¶[0102], where “the alarm manager issues the audio alarms according to the … tonal settings when the audio alarms are triggered by an event,” ¶[0115], where “speaker assembly includes a speaker and an acoustic resonator that, when used in combination, is configured to alter amplitudes of an acoustic output (e.g., an adaptive alarm as described above) at selected frequencies,” ¶[0120], where “As noted above, to alter the intensity, volume, or other characteristics of an audible output such as an alarm, one or more frequencies associated with the audible output can be adapted based upon various factors … a frequency of a first instance of an audible output such as an alarm can be selected such that the acoustic resonator does not amplify the volume and intensity output, thereby resulting in the alarm being output at a first volume level. As the alarm is adapted to the second instance, the frequency can be adapted such that the acoustic resonator can amplify the volume and intensity of the alarm, thereby resulting in the alarm being output at a second volume level that is higher than the first volume level,” ¶[0125], where “the resonator can be design using the principles described herein to increase the amplitudes corresponding to a critical range of frequencies of a device alarm. For example, such critical range of frequencies may be frequencies associated with alarm tones,” ¶[0126], where “a microphone associated with the speaker assembly 714 detects a background noise level (i.e., background sound pressure level), and, in cooperation with a processor, enables adaptation of a sound pressure level of an alarm (or other acoustic output) according to an urgency of the alarm … more urgent alarms can have greater volumes that lower priority alarms.” Examiner interprets that tone of a sound correlates to frequency of the sound since frequency alters pitch or tone. Furthermore, since the volume increase correlates to the frequency change, where the frequency change acts to increase volume, the more urgent sound will have a different frequency, and consequently, tone. Additionally, the countdown to an electric shock is a more urgent event such that it will be prioritized over the warning sound and consequently set to a greater volume than the warning sound when both are emitted at the same time, and since the greater volume changes frequency or tone, the two sounds utilize different tones.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Kaib, which teaches that the sound controller makes the tone of the warning sound during output of the timing sound different from the tone of the warning sound during non-output of the timing sound, with the modified invention of Dascoli in order to enable the alarms to be perceived by the intended recipients with partial hearing loss (Kaib ¶[0102]) and to prioritize more urgent alarms (Kaib ¶[0126]).
Regarding claim 6, Dascoli in combination with Chapman and Kaib teaches all limitations of claim 1 as described in the rejection above.
Kaib teaches that the sound controller changes at least one of volume, scale, and tone of the timing sound in accordance with a number of times of output of the timing sound (¶[0126], where “more urgent alarms can have greater volumes that lower priority alarms.” Examiner interprets that an increased number of times of output of the timing sound relates to the countdown timer, where subsequent outputs correlate to a lower number and an imminence of a shock from the defibrillator. Additionally, a lower number in the countdown will indicate higher urgency since the shock will be imminent at the end of the countdown.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Kaib, which teaches that the sound controller changes at least one of volume of the timing sound in accordance with a number of times of output of the timing sound, with the modified invention of Dascoli in order to prioritize more urgent alarms (Kaib ¶[0126]).
Regarding claim 7, Dascoli in combination with Chapman and Kaib teaches all limitations of claim 6 as described in the rejection above.
Kaib teaches that the sound controller increases the volume of the timing sound in accordance with the number of times of output of the timing sound (¶[0126], where “more urgent alarms can have greater volumes that lower priority alarms.” Examiner interprets that an increased number of times of output of the timing sound relates to the countdown timer, where subsequent outputs correlate to a lower number and an imminence of a shock from the defibrillator. Additionally, a lower number in the countdown will indicate higher urgency since the shock will be imminent at the end of the countdown.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Kaib, which teaches that the sound controller increases the volume of the timing sound in accordance with the number of times of output of the timing sound, with the modified invention of Dascoli in order to prioritize more urgent alarms (Kaib ¶[0126]).
Regarding claim 8, Dascoli in combination with Chapman and Kaib teaches all limitations of claim 6 as described in the rejection above.
Kaib teaches that the sound controller raises the scale of the timing sound in accordance with the number of times of output of the timing sound (¶[0102], where “the alarm manager issues the audio alarms according to the frequency, amplitude and tonal settings when the audio alarms are triggered by an event,” ¶[0115], where “speaker assembly includes a speaker and an acoustic resonator that, when used in combination, is configured to alter amplitudes of an acoustic output (e.g., an adaptive alarm as described above) at selected frequencies,” ¶[0120], where “As noted above, to alter the intensity, volume, or other characteristics of an audible output such as an alarm, one or more frequencies associated with the audible output can be adapted based upon various factors … a frequency of a first instance of an audible output such as an alarm can be selected such that the acoustic resonator does not amplify the volume and intensity output, thereby resulting in the alarm being output at a first volume level. As the alarm is adapted to the second instance, the frequency can be adapted such that the acoustic resonator can amplify the volume and intensity of the alarm, thereby resulting in the alarm being output at a second volume level that is higher than the first volume level,” ¶[0126], where “a microphone associated with the speaker assembly 714 detects a background noise level (i.e., background sound pressure level), and, in cooperation with a processor, enables adaptation of a sound pressure level of an alarm (or other acoustic output) according to an urgency of the alarm … more urgent alarms can have greater volumes that lower priority alarms.” Examiner interprets that scale of a sound correlates to frequency and amplitude of the sound. Furthermore, since the volume increase correlates to the frequency and amplitude changes, where an amplitude increase will increase volume, the more urgent sound will have a larger amplitude, and consequently, scale. Additionally, the countdown to an electric shock is a more urgent event, where subsequent outputs correlate to a lower number and an imminence of a shock from the defibrillator, and a lower number in the countdown will indicate higher urgency since the shock will be imminent at the end of the countdown. Consequently, lower numbers in the countdown will be prioritized, and be set to a greater volume and thus scale.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Kaib, which teaches that the sound controller raises the scale of the timing sound in accordance with the number of times of output of the timing sound, with the modified invention of Dascoli in order to enable the alarms to be perceived by the intended recipients with partial hearing loss (Kaib ¶[0102]) and to prioritize more urgent alarms (Kaib ¶[0126]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Dascoli, Chapman, and Kaib as applied to claim 1 above, and further in view of Freeman at el. (hereinafter “Freeman”) (U.S. Pub. No. 2019/0282823 A1).
Regarding claim 9, Dascoli in combination with Chapman and Kaib teaches all limitations of claim 1 as described in the rejection above.
Although Dascoli teaches user prompts prior to application of a shock (¶[0121], where “The instruction 1000 can include textual instructions. For example, the textual instruction can advise a user to “press flashing shock button,” “press shock button,” “press shock button semi,” “press shock button fully,” or the like. The textual instruction can be delivered in auditory form”), none of Dascoli, Chapman, nor Kaib teach that at least before output of the timing sound, the sound controller outputs a guidance sound from the sound generator; and wherein the guidance sound calls attention to a rescuer so as to prompt the rescuer to move away from the subject.
Freeman teaches a medical device that provides a defibrillation shock (Abstract), and further teaches that at least before output of the timing sound, the sound controller outputs a guidance sound from the sound generator (¶[0108], where “In state 620, the one or more capacitors are fully charged and capable of delivering one or more defibrillating shocks to the body of the patient. In state 620, the portable treatment controller issues another notification to the patient and any proximate bystanders. The notification may be similar to the notification provided in state 610, but is followed by instructions to the patient and any bystanders that may be present. The instructions can include, for example, audible instructions that are communicated to the patient and any bystanders via a speaker on the portable treatment controller 120, the user interface pod … The instructions can also be configured to alert any bystanders not to provide the response and to move away from the patient because defibrillation is imminent. In response to providing the requested response, the portable treatment controller continues to monitor the ECG signals obtained from the patient and proceeds to state 630. In the event that the requested response is not provided, the portable treatment controller proceeds to state 640,” ¶[0109], where “In state 630 the portable treatment controller sets a timer that delays the administration of defibrillation to the patient for a predetermined time, based on the receipt of the requested response. In some embodiments, the predetermined time is approximately 10 seconds.” Examiner interprets that the guidance sound, which includes the instruction to move away, is given prior to the timing sound since the timer setting is subsequent the direction to move away.); and
wherein the guidance sound calls attention to a rescuer so as to prompt the rescuer to move away from the subject (¶[0108], where “The instructions can also be configured to alert any bystanders not to provide the response and to move away from the patient because defibrillation is imminent”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Freeman, which teaches that at least before output of the timing sound, the sound controller outputs a guidance sound from the sound generator; and wherein the guidance sound calls attention to a rescuer so as to prompt the rescuer to move away from the subject, with the modified invention of Dascoli in order to prompt any bystanders to move away since defibrillation is imminent (Freeman ¶[0108]) and to prevent bystanders from being shocked through contact with the patient.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Dascoli, Chapman, and Kaib as applied to claim 1 above, and further in view of Ternes at el. (hereinafter “Ternes”) (U.S. Pub. No. 2014/0236261 A1, IDS Reference No. 29 from IDS dated 10/06/2025).
Regarding claim 10, Dascoli in combination with Chapman and Kaib teaches all limitations of claim 1 as described in the rejection above.
Dascoli teaches a display (¶[0028], where “The user interface includes a graphical display 120 which can display instructions, treatment feedback, and other information to a user which may be useful for administering resuscitative therapy,” ¶[0047], where “the AED display 120 may provide instructions and feedback information which is suitable for treatment of the adult patient,” ¶[0069], where “The user interface of the AED 100 may include a speaker 140. The speaker 140 can provide audio instructions and feedback to the user during treatment. The speaker 140 can provide audio of the instructions which are displayed on the screen so that the user does not have to read the display”) configured to present:
at least one of time information regarding a time length until the electric shock is delivered (¶[0120], where “FIG. 10A shows an example of an instruction 1000 displayed if an electric shock is recommended. The instruction can be shown on the display 120 and can include pictorial, textual, and auditory instructions,” ¶[0122], where “the instructions in FIGS. 10B-10D can be shown in sequence to count down to the moment when the electric shock can occur. In some examples, the countdown can begin immediately once the computer processor determines that the electric shock is recommended. The countdown can serve as a safety measure such that the user is not accidentally shocked by the AED when handling the electrode assembly. The instructions can include large numerical digits 1020 which decrease in value in subsequent instructions. For example, the AED can countdown from three to two to one before shocking”);
an illustration regarding reception of the electric shock (¶[0123], where “once the countdown is completed the AED can administer the electric shock. In some examples, the electric shock can be applied immediately when the shock button 170 is pressed. Once the electric shock has occurred, a confirmation screen 1100 can be displayed”); and
a warning text regarding the reception of the electric shock (¶[0122], where “The instructions can include large numerical digits 1020 which decrease in value in subsequent instructions. For example, the AED can countdown from three to two to one before shocking. The numerical digits 1020 can be accompanied by the shock symbol 1175. The shock symbol 1175 can match a symbol on the shock button 170. The shock symbol can be a symbol which connotes a relationship to electricity, such as a lightning bolt”); and
a display controller configured to control the display (¶[0067], where “The display 120 can also immediately toggle between adult and pediatric instructions and images when the control 130 is toggled”).
Although Dascoli teaches that the display may have varying colors related to the instructions (¶[0120], where “The instruction can be shown on the display 120 and can include pictorial, textual, and auditory instructions. In some examples, the instruction can include a bright, vibrant color (e.g. orange, red, or similar)”), none of Dascoli, Chapman, nor Kaib teach that the display controller changes a color presented on the display in accordance with the time length until the electric shock is delivered.
Ternes teaches a defibrillator (¶[0039], where “The IMD 104 may be a stand-alone neural stimulator, or may be combined with other device such as, without limitation, myocardial stimulators. An example of a myocardial stimulator includes a cardiac pacemaker, a defibrillator, a cardiac resynchronization therapy (CRT) device, or a combination of such devices”), and further teaches that the display controller changes a color presented on the display in accordance with the time length until the electric shock is delivered (¶[0061], where “the visual indication can be configured as a countdown timer such as illustrated in FIG. 9C … the countdown timer 902 in the FIG. 9 indicates "3" which can indicate that the current state (e.g. stimulation ON) state will complete in 3 units of time such as 3 seconds or any other. The time remaining may be displayed … The display also may change the brightness or color or other representation as the countdown gets closer to the end. For example, the display may be a first color during a first portion of the count down, and then switch to another color during a second portion of the countdown (e.g. last "x" seconds)”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Ternes, which teaches that the display controller changes a color presented on the display in accordance with the time length until the electric shock is delivered, with the modified invention of Dascoli in order to represent the countdown getting closer to the end (Ternes ¶[0061]) and to more clearly display the status of the countdown to a user.
Conclusion
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/SEFRA D. MANOS/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792