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 .
Claim interpretation
The claims recite “a first multi-sensory alarm and a second multi-sensory alarm”. The specification and the application as originally presented does not provide explicit definition of what these first and second multi-sensory alarms to be. The published specification at paragraph [0041] states: “[t]he alert module 304 may activate a multi-sensory alarm. The multi-sensory alarm may consist of a visual, auditory, and tactile alert. The alert module 304 may determine when and what sequence to provide visual, auditory, and tactile feedback. The alert module 304 may initially provide discreet feedback to the user and await a response, if no response is received, the alert module 304 may escalate the alert as necessary.”. Therefore, the first multi-sensory alarm and the second multi-sensory alarm are understood to be any combination of visual, auditory, and tactile alerts that are outputted at a first and a second time.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20160328529 A1 to Kaib et al. (hereinafter “Kaib”).
Regarding claim 1. Kaib discloses a wearable cardioverter defibrillator (WCD) system (para 0006, 0009, 0044, 0062, etc., “a wearable medical device”) comprising: a support structure configured to be worn by a patient (para 0115, fig. 6); at least one communication device in communication with (para 0044, fig. 1 “a communication network interface 106”) a processor (para 0044, fig. 1 “processor 118”) wherein the at least one communication device is configured to output a plurality of multi-sensory alarms comprising at least a first multi-sensory alarm and a second multi-sensory alarm (para 0044 “alarm manager”, 0047-0050, 0120, etc.); and the processor configured to: detect an event occurring at the WCD system (para 0067, act 206, “monitor event”, para 0120); in response to the detected event, activate the first multi-sensory alarm at the at least one communication device, the first multi-sensory alarm being associated with one or more parameters (para 0068, act 208 “produces an alarm”, para 0120); and in response to the detected event, activate the second multi-sensory alarm at the at least one communication device (para 0009, 0017, “issuing a second instance of the alarm, the second instance of the alarm having the at least one adapted characteristic.”, para 0120) but fails to explicitly disclose wherein one or more parameters associated with the second multi-sensory alarm are synchronized with the one or more parameters associated with the first multi-sensory alarm.
It is noted that the claim, nor the specification, provide any details on how the one or more parameters of the first and second multi-sensory alarm are synchronized. Therefore, under BRI, any correlation between the first and second alarms is understood to be synchronizing at least certain parameters between the first and second alarm. Here, Kaib discloses a relationship between the first and second instance of the alarms (para 0080, 0120) in order to adapt the characteristics of an alarm issued by a wearable medical device to increase the efficacy of a wearable medical device while maintaining or enhancing the usage experience of patients wearing the medical device (para 0008). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to synchronize the timing, volume, etc., between the first and second instance of het alarms to provide the predictable result of increasing the efficacy.
Regarding claim 2. Kaib renders obvious the WCD system of claim 1, wherein the first multi-sensory alarm is a combination of at least two of a visual alarm, an audible alarm, and a haptic alarm (para 0024, 0041, 0080, “different sensory outputs such as optical (a display, LED, illuminated electrode, etc. . . . ), auditory (a speaker), and tactile (vibrating output) outputs”).
Regarding claim 3. Kaib renders obvious the WCD system of claim 1, wherein the one or more parameters associated with one of the first multi-sensory alarm and the second multi-sensory alarm comprise volume, pitch, tone, and/or timbre of an audible alarm (para 0082 “volume”, “intensity”).
Regarding claim 4. Kaib renders obvious the WCD system of claim 1, wherein the one or more parameters associated with one of the first multi-sensory alarm and the second multi-sensory alarm comprise a blinking light, an image, and/or text of a visual alarm (para 0080 “display, LED, illuminated electrode, etc. . . . ), auditory (a speaker), and tactile (vibrating output) output”; anything provided on the display would be in the form of image, text, etc.).
Regarding claim 5. Kaib renders obvious the WCD system of claim 1, wherein the one or more parameters associated with one of the first multi-sensory alarm and the second multi-sensory alarm comprise one or more vibrational patterns or waveforms, emitting from the at least one communication device, of a haptic alarm (para 0082).
Regarding claim 6. Kaib renders obvious the WCD system of claim 1, wherein the second multi-sensory alarm is a combination of at least two of a visual alarm, an audible alarm, and a haptic alarm (para 0024, 0041, 0080, “different sensory outputs such as optical (a display, LED, illuminated electrode, etc. . . . ), auditory (a speaker), and tactile (vibrating output) outputs”).
Regarding claim 7. Kaib renders obvious the WCD system of claim 1, wherein the event comprises one or more conditions of the WCD system or the patient (para 0024, 0089 “the event of interest is detection of a misplaced or improperly attached electrode”).
Regarding claim 8. Kaib renders obvious the WCD system of claim 1, wherein the processor is further configured to: determine a severity of the event occurring at the WCD system; and determine an urgency of an alert based at least in part on the determined severity (para 0108 “based on the severity of the event of interest”).
Regarding claim 9. Kaib renders obvious the WCD system of claim 8, wherein the one or more parameters associated with at least one of the first multi-sensory alarm and the second multi-sensory alarm vary based on the determined urgency of the alert (para 0108 “adjustments of the intensity, issuance rate or duration of an alarm based on the severity of the event of interest”).
Regarding claim 10. Kaib renders obvious the WCD system of claim 1, wherein the processor is further configured to determine a timing and sequence of the first multi-sensory alarm and the second multi-sensory alarm (para 0108 “adjustments of the intensity, issuance rate or duration of an alarm based on the severity of the event of interest”).
Claim(s) 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib (US 20160328529) in view of US 20120112903 A1 to Kaib et al. (hereinafter “Kaib ‘903”).
Regarding claim 11. Kaib discloses a wearable cardioverter defibrillator (WCD) system (para 0006, 0009, 0044, 0062, etc., “a wearable medical device”) comprising: a support structure configured to be worn by a patient (para 0115, fig. 6); at least one communication device in communication (para 0044, fig. 1 “a communication network interface 106”) with a processor (para 0044, fig. 1 “processor 118”), wherein the at least one communication device is configured to output at least one of a plurality of multi-sensory alarms (para 0044 “alarm manager”, 0047-0050, 0120, etc.), and wherein the plurality of multi-sensory alarms comprises at least a first multi-sensory alarm and a second multi-sensory alarm para 0009, 0017, “issuing a second instance of the alarm, the second instance of the alarm having the at least one adapted characteristic.”, para 0120); an alert button coupled to the support structure (para 0122 “button 708”), wherein the alert button is configured to detect an input from the patient (para 0122, fig. 7); and the processor configured to: detect an event occurring at the WCD system (para 0067, act 206, “monitor event”, para 0120); in response to the detected event, cause output of the first multi-sensory alarm by at least one of the at least one communication device, the first multi-sensory alarm being associated with one or more parameters (para 0068, act 208 “produces an alarm”, para 0120); and in response to the detected event, cause output of the second multi-sensory alarm by at least one of the at least one communication device (para 0009, 0017, “issuing a second instance of the alarm, the second instance of the alarm having the at least one adapted characteristic.”, para 0120), but fails to explicitly disclose wherein one or more parameters associated with the second multi-sensory alarm are synchronized with the one or more parameters associated with the first multi-sensory alarm.
It is noted that the claim, nor the specification, provide any details on how the one or more parameters of the first and second multi-sensory alarm are synchronized. Therefore, under BRI, any correlation between the first and second alarms is understood to be synchronizing at least certain parameters between the first and second alarm. Here, Kaib discloses a relationship between the first and second instance of the alarms (para 0080, 0120) in order to adapt the characteristics of an alarm issued by a wearable medical device to increase the efficacy of a wearable medical device while maintaining or enhancing the usage experience of patients wearing the medical device (para 0008). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to synchronize the timing, volume, etc., between the first and second instance of het alarms to provide the predictable result of increasing the efficacy.
Kaib fails to disclose wherein the alert button is configured to output at least one of the plurality of multi-sensory alarms
Kaib ‘903, from a similar field of endeavor teaches the remote response button 430 may include an audio output device, such as a loudspeaker, and audio circuitry to repeat the same alarms, voice prompts, and voice messages that would be provided by the wearable medical device (para 0049). It would have been obvious to modify the disclosure of Kaib with the known teachings of Kaib ‘903 to provide the predictable result of repeating the alarms, voice prompts, and voice messages that would be provided by the wearable medical device further prompting an alert to the patient or a bystander to a medical condition (para 0005).
Regarding claim 12. Kaib as modified by Kaib ‘903 renders obvious the WCD system of claim 11, wherein the processor is further configured to: receive the input from the patient via the alert button; and modify at least one of the plurality of multi-sensory alarms based on the received input (Kaib ‘903, para 0038, 0049).
Regarding claim 13. Kaib as modified by Kaib ‘903 renders obvious the WCD system of claim 12, wherein the at least one of the plurality of multi-sensory alarms is modified to change at least one of intensity, tempo, volume, and length of the multi-sensory alarm (Kaib, para 0108 “adjustments of the intensity, issuance rate or duration of an alarm based on the severity of the event of interest”).
Regarding claim 14. Kaib as modified by Kaib ‘903 renders obvious the WCD system of claim 11, wherein at least one of the first multi-sensory alarm and the second multi-sensory alarm is a combination of at least two of a visual alarm, audible alarm, and haptic alarm (Kaib, para 0024, 0041, 0080, “different sensory outputs such as optical (a display, LED, illuminated electrode, etc. . . . ), auditory (a speaker), and tactile (vibrating output) outputs”).
Regarding claim 15. Kaib as modified by Kaib ‘903 renders obvious the WCD system of claim 14, wherein each of the first multi-sensory alarm and the second multi-sensory alarm are output by each of the at least one communication device (para 0068, act 208 “produces an alarm”, para 0120) and the alert button (Kaib ‘903, para 0049).
Regarding claim 16. Kaib as modified by Kaib ‘903 renders obvious the WCD system of claim 15, wherein the processor is further configured to: harmonize at least two of the visual alarm, the audible alarm, and output of the haptic alarm by each of the at least one communication device and the alert button (Kaib ‘903, para 0049).
Regarding claim 17. A wearable cardioverter defibrillator (WCD) system (para 0006, 0009, 0044, 0062, etc., “a wearable medical device”) comprising: a support structure configured to be worn by a patient (para 0115, fig. 6); at least one communication device in communication (para 0044, fig. 1 “a communication network interface 106”) with a processor (para 0044, fig. 1 “processor 118”), wherein the at least one communication device is configured to output at least a first multi-sensory alarm of a plurality of multi-sensory alarms (para 0044 “alarm manager”, 0047-0050, 0120, etc.); an alert button coupled to the support structure (para 0122 “button 708”); and the processor configured to: detect an event occurring at the WCD system (para 0067, act 206, “monitor event”, para 0120); in response to the detected event, activate the first multi-sensory alarm at the at least one communication device (para 0068, act 208 “produces an alarm”, para 0120); and in response to the detected event, activate the second multi-sensory alarm (para 0009, 0017, “issuing a second instance of the alarm, the second instance of the alarm having the at least one adapted characteristic.”, para 0120), wherein the second multi-sensory alarm is synchronized with the first multi-sensory alarm at the at least one communication device.
Kaib fails to explicitly disclose wherein one or more parameters associated with the second multi-sensory alarm are synchronized with the one or more parameters associated with the first multi-sensory alarm.
It is noted that the claim, nor the specification, provide any details on how the one or more parameters of the first and second multi-sensory alarm are synchronized. Therefore, under BRI, any correlation between the first and second alarms is understood to be synchronizing at least certain parameters between the first and second alarm. Here, Kaib discloses a relationship between the first and second instance of the alarms (para 0080, 0120) in order to adapt the characteristics of an alarm issued by a wearable medical device to increase the efficacy of a wearable medical device while maintaining or enhancing the usage experience of patients wearing the medical device (para 0008). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to synchronize the timing, volume, etc., between the first and second instance of het alarms to provide the predictable result of increasing the efficacy.
Kaib fails to disclose wherein the alert button is configured to output at least one of the plurality of multi-sensory alarms
Kaib ‘903, from a similar field of endeavor teaches the remote response button 430 may include an audio output device, such as a loudspeaker, and audio circuitry to repeat the same alarms, voice prompts, and voice messages that would be provided by the wearable medical device (para 0049). It would have been obvious to modify the disclosure of Kaib with the known teachings of Kaib ‘903 to provide the predictable result of repeating the alarms, voice prompts, and voice messages that would be provided by the wearable medical device further prompting an alert to the patient or a bystander to a medical condition (para 0005).
Regarding claim 18. Kaib as modified by Kaib ‘903 renders obvious the WCD system of claim 17, wherein at least one of the first multi-sensory alarm and the second multi-sensory alarm is a combination of at least two of a visual alarm, audible alarm, and haptic alarm (Kaib, para 0024, 0041, 0080, “different sensory outputs such as optical (a display, LED, illuminated electrode, etc. . . . ), auditory (a speaker), and tactile (vibrating output) outputs”).
Regarding claim 19. Kaib as modified by Kaib ‘903 renders obvious the WCD system of claim 17, further comprising a discharge circuit configured to discharge a stored electrical charge through a body of the patient (Kaib, para 0006, 0023-0024 “therapeutic shock”).
Regarding claim 20. Kaib as modified by Kaib ‘903 renders obvious the WCD system of claim 17, wherein the processor is further configured to: determine a no urgency of the detected event; and cease at least one of the plurality of multi-sensory alarms for a predetermined length of time based on the no urgency of the detected event, wherein the predetermined length of time is determined based on a severity of the detected event (Kaib, para 0108 “adjustments of the intensity, issuance rate or duration of an alarm based on the severity of the event of interest”).
Double Patenting
Claims 1-17 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of U.S. Patent No. US12090332B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-17 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of U.S. Patent No. US11198015B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796