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 .
Election/Restrictions
Claims 9-10, 12, 13-24, 32, and 34-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/14/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/20/2024 and 05/12/2025 is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Fig. 1, element 100. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The use of the term Bluetooth, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 contains the trademark Bluetooth. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark is used to describe radio. For examination purposes, the examiner will interpret the claim to refer to wireless communication between a first transceiver and a second transceiver.
Claim 51 recites the limitation "data" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 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.
Claim 1-2, 4, 7-8, 25-27, 29, 31, and 43-47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pflugh et al. (US 20170332942 A1), hereinafter Pflugh.
Regarding claim 1, Pflugh teaches an implantable medical device (IMD) (Fig. 4A, element 400 – monitoring device, para. 0032 (400 may be implanted to the patient)) comprising:
a first transceiver (para. 0023 (wireless communication interface 210 that may transmit wireless communication signals), 0063 (424 may be operated as the wireless communication interface 210 of FIG. 1))
configured to operate in a first advertising mode, whereby the first transceiver transmits a first advertising signal (para. 0020 (announcement messages may Include some identification information of the device), 0025 (device 200 operates to determine dynamically when or how often one or more announcing or advertising messages, data packets, or other signals are to be transmitted))
at a first rate (Fig. 2, element 302, para. 0028 (announcement timing control module 222 may set an initial frequency for transmission of announcement messages, data packets, or other signals), 0129 (FIG. 6 is a list of example announcement frequency modes 600 or states that the announcement timing control module 222 of FIGS. 1, 4A, and/or 4B may provide based on the announcement frequency factors 500));
one or more sensors (Fig. 4A, element 108 – physiologic sensors) configured to sense first data (para. 0058 (physiological sensor 108 may be an optical sensor), 0042 (optical sensor may be used to determine a person's heart activity));
a memory storing instructions (Fig. 4A, element 494 – memory); and
a microcontroller circuit (Fig. 4A, element 460 – program microcontroller) operatively coupled to the first transceiver (Fig. 4A), the microcontroller circuit being configured, in response to executing the instructions stored in the memory (para. 0065 (microcontroller 460 may perform the functions of the wireless communication control module 220, and/or other functions described herein by executing instructions stored in the memory 494)),
to selectively cause the first transceiver to begin operating in the first advertising mode based on the first data (para. 0094 (announcement frequency factors 500 that may influence operation of the announcement timing control module 222 of FIGS. 1, 4A and 4B. Examples may include a current detected heart activity 504), 0129 (FIG. 6 is a list of example announcement frequency modes 600 or states that the announcement timing control module 222 of FIGS. 1, 4A, and/or 4B may provide based on the announcement frequency factors 500)).
Regarding claim 2, Pflugh teaches the IMD of claim 1, wherein the microcontroller circuit (Fig. 4A, element 460 – program microcontroller) is configured to selectively cause the first transceiver (para. 0023 (wireless communication interface 210 that may transmit wireless communication signals), 0063 (424 may be operated as the wireless communication interface 210 of FIG. 1)) to operate:
in the first advertising mode (para. 0129 (fast frequency mode 602 may result in an announcement message, data packet, or other signal being transmitted via the telemetry circuit 424 once every 30 seconds)); or
in a second advertising mode, whereby the first transceiver does not transmit an advertising signal or transmits the first advertising signal at a second rate less than the first rate (para. 0129 (the slow frequency mode 604 may result in an announcement frequency of three minutes… off mode 606 (during which no announcement messages, data packets, or other signals are transmitted))).
Regarding claim 4, Pflugh teaches a medical system, comprising: the IMD of claim 1; and
an external device (Fig. 4A, element 230 – external device) comprising a second transceiver configured to operate in a first searching mode, whereby the second transceiver searches for an advertising signal, wherein the IMD and the external device are configured to establish a communication channel between the IMD and the external device in response to the second transceiver receiving the first advertising signal and transmitting a reply signal to the first transceiver (para. 0023 (electronic device 200 includes a wireless communication interface 210 that may transmit wireless communication signals to, and/or receive wireless communication signals from, an external device 230, such as by way of an established wireless communication connection 250)).
Regarding claim 7, Pflugh teaches the medical system of claim 4, wherein the first transceiver comprises a first Bluetooth radio, and the external device comprises a second Bluetooth radio (para. 0023 (wireless communication interface 210 may Include wireless signal transmitters, wireless signal receivers, and/or other circuitry for providing functionality. In one example, the wireless signals conform to a wireless communication standard, such as Bluetooth®… that employs presence announcing or advertising to enable communication between at least two devices, such as by way of establishing a wireless communication connection between the electronic device 200 and the external device 23)).
Regarding claim 8, Pflugh teaches the IMD of claim 1, wherein the first data comprises physiological data (para. 0094 (announcement frequency factors 500 that may influence operation of the announcement timing control module 222 of FIGS. 1, 4A and 4B. Examples may include a current detected heart activity 504)), and
the microcontroller circuit (Fig. 4A, element 460 – program microcontroller) is configured to selectively cause the first transceiver to begin operating in the first advertising mode (para. 0129 (fast frequency mode 602 may result in an announcement message, data packet, or other signal being transmitted via the telemetry circuit 424 once every 30 seconds))
in response to determining, based on the physiological data, that a physiological condition has occurred or is present (para. 0106 (announcement timing control module 222 may base the announcement frequency at least in part on a current detected event 512 [which] may be determined by… one or more physiologic sensors 108.. upon detection of a life-threatening event, such as an acute myocardial infarction or a stroke, the electronic device 200 increases the announcement frequency via the announcement timing control module 222 in response to such an episode)).
Regarding claim 25, Pflugh teaches the IMD of claim 1, comprising a clock configured to determine a time of day (para. 0096 (announcement timing control module 222 may base the announcement frequency at least in part on the current time of day 502)),
wherein the microcontroller circuit (Fig. 4A, element 460 – program microcontroller) is configured to selectively cause the first transceiver (para. 0023 (wireless communication interface 210 that may transmit wireless communication signals), 0063 (424 may be operated as the wireless communication interface 210 of FIG. 1)) to operate in the first advertising mode (para. 0129 (fast frequency mode 602 may result in an announcement message, data packet, or other signal being transmitted via the telemetry circuit 424 once every 30 seconds)) or
in a second advertising mode, whereby the first transceiver does not transmit an advertising signal or transmits the first advertising signal at a second rate less than the first rate (para. 0129 (the slow frequency mode 604 may result in an announcement frequency of three minutes… off mode 606 (during which no announcement messages, data packets, or other signals are transmitted))), and
wherein the microcontroller circuit (Fig. 4A, element 460 – program microcontroller) is configured to collect second data about time(s) of day (Fig. 6, element 502 – current time of day; announcement frequency factor) when the first transceiver is operated in the first advertising mode, and to selectively cause the first transceiver to begin operating in the first advertising mode based on the time of day and the second data (para. 0116 (announcement timing control module 222 may determine one or more times during the day that the patient is typically more active, as well as times during the day that the patient is more likely to experience a clinical episode, and increase the announcement frequency during at least some of those times of day, as indicated by the current time of day 502), 0096 (The particular times of day and their associated announcement frequencies may be configured by way of the telemetry circuit 424)).
Regarding claim 26, Pflugh teaches an implantable medical device (IMD) (Fig. 4A, element 400 – monitoring device, para. 0032 (400 may be implanted to the patient)), comprising:
a first transceiver (para. 0023 (wireless communication interface 210 that may transmit wireless communication signals), 0063 (424 may be operated as the wireless communication interface 210 of FIG. 1)) configured to operate in a high-power connectable mode and in a low-power mode (para. 0129 (FIG. 6 is a list of example announcement frequency modes 600 or states that the announcement timing control module 222 of FIGS. 1, 4A, and/or 4B may provide based on the announcement frequency factors 500));
a memory storing instructions (Fig. 4A, element 494 – memory); and
a microcontroller circuit (Fig. 4A, element 460 – program microcontroller) operatively coupled to the first transceiver, the microcontroller circuit being configured, in response to executing the instructions stored in the memory (para. 0065 (microcontroller 460 may perform the functions of the wireless communication control module 220, and/or other functions described herein by executing instructions stored in the memory 494)), to selectively cause the first transceiver to operate in the high-power connectable mode or in the low-power mode (para. 0025 (device 200 operates to determine dynamically when or how often one or more announcing or advertising messages, data packets, or other signals are to be transmitted), Fig. 6).
Regarding claim 27, Pflugh teaches the IMD of claim 26, wherein the first transceiver is configured, when operating in the high-power connectable mode, to transmit a first advertising signal at a first rate (para. 0129 (fast frequency mode 602 may result in an announcement message, data packet, or other signal being transmitted via the telemetry circuit 424 once every 30 seconds)), and
wherein the first transceiver is configured, when operating in the low-power mode, to not transmit an advertising signal or to transmit the first advertising signal at a second rate less than the first rate (para. 0129 (the slow frequency mode 604 may result in an announcement frequency of three minutes… off mode 606 (during which no announcement messages, data packets, or other signals are transmitted))).
Regarding claim 29, Pflugh teaches IMD of claim 26, wherein the microcontroller circuit (Fig. 4A, element 460 – program microcontroller) is configured to cause the IMD to perform one or more core operations while the first transceiver operates in the low-power mode (para. 0129 (the slow frequency mode 604 may result in an announcement frequency of three minutes… off mode 606 (during which no announcement messages, data packets, or other signals are transmitted))), the one or more core operations comprising at least one of providing stimulation, sensing physiological data, or discharging a medical substance (para. 0125 (microcontroller 460 or 60 monitors the physiologic sensor 108 (e.g., accelerometer) for any significant measurement drop), 0094 (announcement frequency factors 500 that may influence operation of the announcement timing control module 222 of FIGS. 1, 4A and 4B. Examples may include a current detected heart activity 504), 0129 (FIG. 6 is a list of example announcement frequency modes 600 or states that the announcement timing control module 222 of FIGS. 1, 4A, and/or 4B may provide based on the announcement frequency factors 500)).
Regarding claim 31, Pflugh teaches the IMD of claim 26, comprising one or more sensors (Fig. 4A, element 108 – physiologic sensors), wherein the microcontroller circuit (Fig. 4A, element 460 – program microcontroller) is configured to cause the first transceiver (para. 0023 (wireless communication interface 210 that may transmit wireless communication signals), 0063 (424 may be operated as the wireless communication interface 210 of FIG. 1)) to transition from operating in the low-power mode to operating in the high-power connectable mode in response to determining, based on physiological data sensed by the one or more sensors, that a physiological condition has occurred or is present (para. 0106 (announcement timing control module 222 may base the announcement frequency at least in part on a current detected event 512 [which] may be determined by… one or more physiologic sensors 108… upon detection of a life-threatening event, such as an acute myocardial infarction or a stroke, the electronic device 200 increases the announcement frequency via the announcement timing control module 222 in response to such an episode)).
Regarding claim 43, Pflugh teaches the IMD of claim 26, comprising a clock configured to determine a time of day (para. 0096 (announcement timing control module 222 may base the announcement frequency at least in part on the current time of day 502)),
wherein the microcontroller circuit (Fig. 4A, element 460 – program microcontroller) is configured to selectively cause the first transceiver (para. 0023 (wireless communication interface 210 that may transmit wireless communication signals), 0063 (424 may be operated as the wireless communication interface 210 of FIG. 1)) to operate in the high-power connectable mode based on the time of day (para. 0129 (fast frequency mode 602 may result in an announcement message, data packet, or other signal being transmitted via the telemetry circuit 424 once every 30 seconds)).
Regarding claim 44, Pflugh teaches the IMD of claim 43, wherein the microcontroller circuit (Fig. 4A, element 460 – program microcontroller) is configured to collect second data about what time(s) of day (Fig. 6, element 502 – current time of day; announcement frequency factor) the first transceiver is operated in the high-power connectable mode, and to selectively cause the first transceiver to operate in the high-power connectable mode based on the second data (para. 0116 (announcement timing control module 222 may determine one or more times during the day that the patient is typically more active, as well as times during the day that the patient is more likely to experience a clinical episode, and increase the announcement frequency during at least some of those times of day, as indicated by the current time of day 502), 0096 (The particular times of day and their associated announcement frequencies may be configured by way of the telemetry circuit 424)).
Regarding claim 45, Pflugh teaches the IMD of claim 44, comprising one or more sensors (Fig. 4A, element 108 – physiologic sensors) wherein the microcontroller circuit (Fig. 4A, element 460 – program microcontroller) is configured to selectively cause the first transceiver to operate in the high-power connectable mode (para. 0129 (fast frequency mode 602 may result in an announcement message, data packet, or other signal being transmitted via the telemetry circuit 424 once every 30 seconds)) in response to at least one of:
determining a physiological condition based on physiological data sensed by the one or more sensors (para. 0106 (announcement timing control module 222 may base the announcement frequency at least in part on a current detected event 512 [which] may be determined by… one or more physiologic sensors 108.. upon detection of a life-threatening event, such as an acute myocardial infarction or a stroke, the electronic device 200 increases the announcement frequency via the announcement timing control module 222 in response to such an episode));
identifying a wake-up signal in data sensed by the one or more sensors (para. 0097 (announcement timing control module 222 may use current detected body position… to confirm or corroborate a determination of announcement frequency based on current time of day. For example, a physiological sensor 108 may detect a patient's posture… if a patient is lying down, this may corroborate that a lower frequency may be used based on a current time of day… If the patient is, however, not lying down, the announcement timing control module 222 may determine that a higher frequency of announcement should be used)); or
determining that a set change has occurred in a position of a patient’s body that the IMD is implanted in (Fig. 5, element 508 – current detected patient physical activity level, para. 0094 (current detected patient body position and/or physical activity level 508), 0104 (patient physical activity level 508 (which may include positional data) may be determined by one or more factors sensed via one or more physiological sensors 108)).
Regarding claim 46, Pflugh teaches a medical system, comprising: the IMD of claim 26;
and an external device (Fig. 4A, element 230 – external device) comprising a second transceiver configured to establish a communication channel with the first transceiver (para. 0023 (electronic device 200 includes a wireless communication interface 210 that may transmit wireless communication signals to, and/or receive wireless communication signals from, an external device 230, such as by way of an established wireless communication connection 250)) when the first transceiver operates in the high-power connectable mode (para. 0129 (the fast frequency mode 602 may result in an announcement message, data packet, or other signal being transmitted via the telemetry circuit 424 once every 30 seconds)).
Regarding claim 47, Pflugh teaches the medical system of claim 46, wherein the first and second transceivers are not configured to establish the communication channel when the first transceiver operates in the low-power mode (para. 0129 (off mode 606 (during which no announcement messages, data packets, or other signals are transmitted))).
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 3 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Pflugh.
Regarding claim 3, Pflugh teaches the IMD of claim 2, comprising:
an implantable pulse generator (IPG) comprising the first transceiver (para. 0066 (In certain embodiments, an electronic device 200, e.g., monitoring device 400 (FIG. 4A) or Implantable stimulation device 100 (FIG. 4B), may include a neuromodulation implantable pulse generator)), the microcontroller circuit (Fig. 4A, element 460 – program microcontroller), the memory (Fig. 4A, element 494 – memory), and a driver configured to generate an electrical current (para. 0074 (atrial pulse generator 70 and the ventricular pulse generator 72 may be generally controlled by the microcontroller 60 via appropriate control signals 76 and 98, respectively, to trigger or inhibit the stimulation pulses));
a lead electrically coupled to the IPG (Fig. 3B, element 20 – lead); and
a stimulation electrode on the lead (Fig. 3B, element 22 – right atrial tip electrode) and electrically coupled to the driver through the lead (para. 0037 (lead 20 may also include a right atrial ring electrode to allow bipolar stimulation or sensing in combination with the atrial tip electrode 22), 0070 (in order to achieve right atrial sensing and stimulation, the connector may include at least one right atrial tip terminal 42 adapted for connection to the atrial tip electrode 22), Fig. 4B),
wherein the microcontroller circuit (Fig. 4B, element 60 – program microcontroller) is operatively coupled to the driver (Fig. 4B) and is configured to cause the driver to generate the electrical current while the first transceiver (para. 0088 (microcontroller 60 may also include a wireless communication control module 220, which may operate as the wireless communication control module 220 of FIG. 1)) operates in the second advertising mode (para. 0083 (sensors 109 may be mounted on or within stimulation device 100 or otherwise in communication with stimulation device 100, in order to permit a user to trigger a wireless communication connection 250 between stimulation device 100 and an external device), 0129 (the slow frequency mode 604 may result in an announcement frequency of three minutes)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pflugh’s IMD to incorporate an IPG with a lead, stimulation electrode, and driver, as Pflugh states that the IMD may include an IPG (para. 0066).
Regarding claim 30, Pflugh teaches IMD of claim 26, wherein IMD comprises:
an implantable pulse generator (IPG) comprising the first transceiver (para. 0066 (In certain embodiments, an electronic device 200, e.g., monitoring device 400 (FIG. 4A) or Implantable stimulation device 100 (FIG. 4B), may include a neuromodulation implantable pulse generator)),
the microcontroller circuit (Fig. 4B, element 60 – microcontroller),
the memory (Fig. 4A, element 94 – memory), and a driver configured to generate an electrical current (para. 0074 (atrial pulse generator 70 and the ventricular pulse generator 72 may be generally controlled by the microcontroller 60 via appropriate control signals 76 and 98, respectively, to trigger or inhibit the stimulation pulses));
a lead electrically coupled to the IPG (Fig. 3B, element 20 – lead); and
a stimulation electrode on the lead (Fig. 3B, element 22 – right atrial tip electrode) and electrically coupled to the driver through the lead (para. 0037 (lead 20 may also include a right atrial ring electrode to allow bipolar stimulation or sensing in combination with the atrial tip electrode 22), 0070 (in order to achieve right atrial sensing and stimulation, the connector may include at least one right atrial tip terminal (A.sub.R TIP) 42 adapted for connection to the atrial tip electrode 22), Fig. 4B).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pflugh’s IMD to incorporate an IPG with a lead, stimulation electrode, and driver, as Pflugh states that the IMD may include an IPG (para. 0066).
Claims 5-6, 28, and 48-53 are rejected under 35 U.S.C. 103 as being unpatentable over Pflugh and in view of Wu et al. (US 20100023085 A1), hereinafter Wu.
Regarding claim 5, Pflugh teaches the medical system of claim 4, wherein the medical system is configured to switch between operating in:
an IMD peripheral mode, whereby the first transceiver operates in the first advertising mode (para. 0020 (announcement messages may Include some identification information of the device), 0025 (device 200 operates to determine dynamically when or how often one or more announcing or advertising messages, data packets, or other signals are to be transmitted)) and the second transceiver operates in the first searching mode (para. 0023 (electronic device 200 includes a wireless communication interface 210 that may transmit wireless communication signals to, and/or receive wireless communication signals from, an external device 230, such as by way of an established wireless communication connection 250)).
Pflugh does not teach an IMD central mode, whereby the first transceiver operates in a second searching mode and the second transceiver operates in a second advertising mode, wherein the first transceiver is configured to search for an advertising signal when operating in the second searching mode, and wherein the second transceiver is configured to transmit second advertising signals when operating in the second advertising mode.
Wu teaches an IMD (Fig. 1, element 102 – IMD) central mode, whereby the first transceiver (Fig. 3, element 304, para. 0037 (FIG. 3 illustrates several sample components of an embodiment of a device 300 (e.g., communication components of the implanted device 102)))
operates in a second searching mode (para. 0039 (implanted device 102 may wakeup on a repeated basis to determine whether the external device 104 is transmitting signals in an attempt to establish a communication session)) and
the second transceiver operates in a second advertising mode (para. 0040 (external device 104 selects a particular channel on which to transmit its request messages)),
wherein the first transceiver is configured to search for an advertising signal when operating in the second searching mode (para. 0039 (implanted device 102 may wakeup on a repeated basis to determine whether the external device 104 is transmitting signals in an attempt to establish a communication session)), and
wherein the second transceiver is configured to transmit second advertising signals when operating in the second advertising mode (para. 0040 (external device 104 initially attempts to establish a communication session with the implanted device 102, the external device 104 selects a particular channel on which to transmit its request messages. Consequently, during the low power sniff operation, the receiver 302 may be configured to scan each of the channels of the designated communication band (e.g., separately or in one or more groups) to determine whether the external device 104 is currently sending messages over any of the channels)).
Pflugh and Wu are considered to be analogous to the claimed invention because they are in the same field of establishing communication channels between an IMD and an external device. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pflugh to incorporate the teachings of Wu and provide the IMD to search for advertising signals and for the external device to transmit advertising signals. Doing so enhances the system by allowing the external device to transmit the advertising signal, in the case that the IMD is unable to properly establish the secure connection between the devices.
Regarding claim 6, Pflugh (in view of Wu) teaches the medical system of claim 5, wherein the first data comprises physiological data (para. 0094 (announcement frequency factors 500 that may influence operation of the announcement timing control module 222 of FIGS. 1, 4A and 4B. Examples may include a current detected heart activity 504)), and
wherein the microcontroller circuit (Fig. 4A, element 460 – program microcontroller) is configured, to cause the first transceiver (para. 0023 (wireless communication interface 210 that may transmit wireless communication signals), 0063 (424 may be operated as the wireless communication interface 210 of FIG. 1)) to operate based on the physiological data, that a physiological condition has occurred or is present (para. 0106 (announcement timing control module 222 may base the announcement frequency at least in part on a current detected event 512 [which] may be determined by… one or more physiologic sensors 108.. upon detection of a life-threatening event, such as an acute myocardial infarction or a stroke, the electronic device 200 increases the announcement frequency via the announcement timing control module 222 in response to such an episode)).
Pflugh does not teach the first transceiver operating in the second searching mode, to cause the first transceiver to search for the advertising signal.
Wu teaches first transceiver operating in the second searching mode, to cause the first transceiver to search for the advertising signal (para. 0039 (implanted device 102 may wakeup on a repeated basis to determine whether the external device 104 is transmitting signals in an attempt to establish a communication session)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pflugh’s first transceiver to incorporate the teachings of Wu listed above and provide the first transceiver to operate in the second search mode, to search for the advertising signal. Doing so would allow the IMD to search for the advertising signal of the external device, to support faster creation of a wireless communication connection between the IMD and the external device during the periods when there is a higher chance of a life-threatening event, so that the external device can be used immediately.
Regarding claim 28, Pflugh teaches the IMD of claim 26, wherein the first transceiver (para. 0023 (wireless communication interface 210 that may transmit wireless communication signals), 0063 (424 may be operated as the wireless communication interface 210 of FIG. 1))
is configured, to operate in the high-power connectable mode (para. 0129 (the fast frequency mode 602 may result in an announcement message, data packet, or other signal being transmitted via the telemetry circuit 424 once every 30 seconds)) and
to use energy at a first rate (para. 0115 (the announcement timing control module 222 may base the announcement frequency at least in part on the current charge level 520 of the battery 110 of the monitoring device 400 or implantable stimulation device 100 in some implementations. For example, relatively or extremely low charge levels of the battery 110 may cause the announcement timing control module 222 to reduce the frequency of the announcement messages, possibly to zero, for at least some period of time to conserve battery charge), low levels of battery causes the frequency of the announcement of the messages to be reduced (low-power mode), thus it's rendered obvious that the high-power connectable mode uses energy at a higher rate than the low-power mode), and
wherein the first transceiver is configured, when operating in the low-power mode (para. 0129 (the slow frequency mode 604 may result in an announcement frequency of three minutes… off mode 606 (during which no announcement messages, data packets, or other signals are transmitted))) and using energy at a second rate less than the first rate (para. 0115 (relatively or extremely low charge levels of the battery 110 may cause the announcement timing control module 222 to reduce the frequency of the announcement messages, possibly to zero, for at least some period of time to conserve battery charge)).
Pflugh does not teach when the first transceiver operates in the high-power connectable mode, to search for advertising signals and wherein the first transceiver is configured, when operating in the low-power mode, to not search for advertising signals or to search for advertising signals while using energy at a second rate less than the first rate.
Wu teaches an implantable medical device (IMD) (Fig. 1, element 102) comprising a first transceiver (Fig. 3, element 304 – transceiver, Fig. 3 shows the communication components of the IMD), wherein the first transceiver is configured, when operating in the high-power connectable mode, to search for advertising signals (Fig. 2, element 212, para. 0044 (device 300 may wakeup from the low power mode to perform a more comprehensive scan on one or more designated channels for signals from the external device 104), 0045 (the higher-power, fully awakened mode may be invoked by enabling (e.g., powering on) all or substantially all of the communication components of the device 300)) and
wherein the first transceiver is configured, when operating in the low-power mode, to not search for advertising signals or to search for advertising signals while using energy at a second rate less than the first rate (Fig. 2, element 202, para. 0039 (transceiver 304 may be intermittently activated (e.g., powered on according to a defined scan interval) to scan for signals within a given RF frequency band), 0041 (receiver 302 may sense for a short period of time and utilize a low power signal detector 306 to detect a signal)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pflugh’s first transceiver to incorporate the teachings of Wu listed above and provide a first transceiver operating in the high-power connectable mode, to search for advertising signals. Doing so would allow the IMD to search for the advertising signal of the external device, to support faster creation of a wireless communication connection between the IMD and the external device.
It also would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pflugh’s first transceiver to incorporate the teachings of Wu listed above and provide a first transceiver operating in the low-power mode, to not search for advertising signals or to search for advertising signals while using energy at a second rate less than the first rate. Doing so conserves the power source of the IMD when communication to the external device is not needed.
Regarding claim 48, Pflugh teaches a method (Fig. 2) for operating an implantable medical device (IMD) comprising a first transceiver, the method comprising:
operating the first transceiver in a low-power mode (Fig. 2, element 302, para. (para. 0028 (announcement timing control module 222 may set an initial frequency for transmission of announcement messages, data packets, or other signals (operation 302). In some examples, the frequency may be once every so many… minutes, or may be zero (e.g., no announcement messages)));
determining that a communication threshold condition has occurred or is present (Fig. 2, element 304 – announcement frequency factors); and
in response to determining that the communication threshold condition has occurred or is present, operating the first transceiver in a high-power connectable mode (Fig. 2, element 308, Fig. 6, element 602), whereby the first transceiver transmits advertising signals at a first rate (para. 0129 (the fast frequency mode 602 may result in an announcement message, data packet, or other signal being transmitted via the telemetry circuit 424 once every 30 seconds)),
the first transceiver uses energy at a higher rate when operating in the high-power connectable mode than when operating in the low-power mode (para. 0115 (the announcement timing control module 222 may base the announcement frequency at least in part on the current charge level 520 of the battery 110 of the monitoring device 400 or implantable stimulation device 100 in some implementations. For example, relatively or extremely low charge levels of the battery 110 may cause the announcement timing control module 222 to reduce the frequency of the announcement messages, possibly to zero, for at least some period of time to conserve battery charge)).
Pflugh does not teach operating the first transceiver in a high-power connectable mode whereby the first searches for advertising signals.
Wu teaches operating the first transceiver (Fig. 3, element 304, para. 0037 (FIG. 3 illustrates several sample components of an embodiment of a device 300 (e.g., communication components of the implanted device 102))) in a high-power connectable mode whereby the first searches for advertising signals (para. 0039 (implanted device 102 may wakeup on a repeated basis to determine whether the external device 104 is transmitting signals in an attempt to establish a communication session)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pflugh’s first transceiver to incorporate the teachings of Wu listed above and provide a first transceiver operating in the high-power connectable mode, to search for advertising signals. Doing so would allow the IMD to search for the advertising signal of the external device, to support faster creation of a wireless communication connection between the IMD and the external device.
Regarding claim 49, Pflugh (in view of Wu) teaches the method of claim 48, wherein, when the first transceiver operates in the low-power mode, the first transceiver does not transmit advertising signals and does not search for advertising signals (para. 0028 (announcement timing control module 222 may set an initial frequency for transmission of announcement messages, data packets, or other signals (operation 302). In some examples, the frequency may be once every so many… minutes, or may be zero (e.g., no announcement messages))).
Regarding claim 50, Pflugh (in view of Wu) teaches the method of claim 48, wherein the determining that the communication threshold condition has occurred or is present (Fig. 2, element 304 – announcement frequency factors) comprises determining that a physiological condition has occurred or is present (Fig. 5, element 512 – current detected event, para. 0094 (a current detected event 512 (e.g., myocardial Infarction, stroke, cardiac ischemia, angina, neuropathic pain))).
Regarding claim 51, Pflugh (in view of Wu) teaches the method of claim 48, wherein the determining that the communication threshold condition has occurred or is present (Fig. 2, element 304 – announcement frequency factors) comprises identifying a wake-up signal in data sensed by the IMD (para. 0099 (announcement timing control module 222 keeps a log of the time of day 502 at which a user attempts to initiate a connection between the electronic device 200 and external device 230. Announcement timing control module 222 may use the log to determine trend information regarding the time of day that a user typically attempts to initiate such a connection. The announcement frequency may then be adjusted based on the trend data.))
Regarding claim 52, Pflugh (in view of Wu) teaches the method of claim 48, wherein the determining that the communication threshold condition has occurred or is present (Fig. 2, element 304 – announcement frequency factors) comprises determining that a set change has occurred in a position of a patient’s body that the IMD is implanted in (Fig. 5, element 508 – current detected patient physical activity level, para. 0094 (current detected patient body position and/or physical activity level 508), 0104 (patient physical activity level 508 (which may include positional data) may be determined by one or more factors sensed via one or more physiological sensors 108)).
Regarding claim 53, Pflugh (in view of Wu) teaches the method of claim 48, wherein the determining that the communication threshold condition has occurred or is present (Fig. 2, element 304 – announcement frequency factors) comprises determining that the time of day is within a set range (Fig. 5, element 502 – current time od day, para. 0096 (an expected time of sleep (e.g., 10 PM to 6 AM) and an expected time of wakefulness (e.g., 6:01 AM to 9:59 PM) may be programmed parameters entered by a user using an external device 230 and telemetry circuit 424)).
Claims 11 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Pflugh and in view of LeBoeuf et al. (US 20080146892 A1), hereinafter Leboeuf.
Regarding claim 11, Pflugh teaches the IMD of claim 8 and the physiological condition (para. 0106 (an acute myocardial infarction or a stroke)).
Pflugh does not teach wherein the physiological condition comprises a seizure.
Leboeuf teaches a medical device (Fig. 4, element 40 – earpiece module) comprising one or more sensors (para. 0157 (person's body motion and head position can be monitored by integrating a motion sensor into an earpiece module)) configured to sense physiological data to determine that a seizure has occurred or is present (para. 0157 (when the head is moved, a motion sensor detects the displaced motion from the origin. A head position monitor can be used to sense convulsions or seizures and relay this information wirelessly to a recording device)).
Pflugh and Leboeuf are considered to be analogous to the claimed invention because they are in the same field of monitoring a patient’s physiological conditions and wirelessly transmitting the data to an external device. Pflugh teaches sensors that are electrically coupled to an IMD, that can be motion sensors and accelerometers to sense physiological data (para. 0082). Leboeuf teaches a motion sensor and an accelerometer that senses a patient’s head movement to sense if the patient is experiencing a seizure, and sending the data to an external device (para. 0157). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pflugh’s sensors to incorporate the teachings of Leboeuf to monitor a physiological condition comprising a seizure. Doing so would have yielded predictable results of a motion sensor and an accelerometer to determine that a seizure is present, based on the physiological data.
Regarding claim 33, Pflugh teaches the IMD device of claim 31 and the physiological condition (para. 0106 (an acute myocardial infarction or a stroke)).
Pflugh does not teach wherein the physiological condition comprises at least one of a seizure or an apneic event.
Leboeuf teaches a medical device (Fig. 4, element 40 – earpiece module) comprising one or more sensors (para. 0157 (person's body motion and head position can be monitored by integrating a motion sensor into an earpiece module)) configured to sense physiological data to determine that a seizure has occurred or is present (para. 0157 (when the head is moved, a motion sensor detects the displaced motion from the origin. A head position monitor can be used to sense convulsions or seizures and relay this information wirelessly to a recording device)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pflugh’s sensors to incorporate the teachings of Leboeuf to monitor a physiological condition comprising a seizure. Doing so would have yielded predictable results of a motion sensor and an accelerometer to determine that a seizure is present, based on the physiological data.
Conclusion
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/EILEEN ROBLES/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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