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
Claims 1 and 11 comprising a module were analyzed for invoking 112f; however claimed module comprises a transceiver configured to communicate and a transceiver is not a generic placeholder (prong A fails). Furthermore, claims comprise processors and memories which are structures that can and perform claimed functionality (prong C fails). Therefore claims do not invoke 112f.
Allowable Subject Matter
Claims 8-9 and 18-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 1-4 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2019/0070423 to Kivi et al. (“Kivi”) in view of U.S. Patent Publication No. 2014/0086125 to Polo et al. (“Polo”).
As to claim 1, Kivi discloses a medical device (Kivi: fig 2 ... implantable device 104 (medical device)) comprising:
one or more processors; one or more sensors configured to generate signals corresponding to one or more physiological signals detected in a body of a user (Kivi: fig 1-10, [0014-142]: fig 2 ... implantable device 104 (medical device) memory 224 processor 222 (one or more processors) transmitter/receiver 216 communication component 200 other implantable device circuitry/software 220 ... electrical components can vary depending on the particular features and functionality of the implantable device 104 (medical device) and these electrical component can include, but are not limited to, one or more processors, memories, transmitters, receivers, transceivers, sensors (one or more sensors), sensing circuitry, therapy circuitry, antennas and other components [0044] ... implantable device 104 (medical device) may include no leads, as in the case of an intracardiac pacemaker or a leadless pressure sensor (one or more sensors ...) ... intracardiac pacemaker for sensing cardiac electrogram signals and/or delivering pacing pulses (... configured to generate signals corresponding to one or more physiological signals detected in a body of a user) [0049]);
a communication module comprising a transceiver configured to communicate wirelessly with first and second receiving devices using a communication protocol that utilizes multiple physical layers (Kivi: fig 1-10, [0014-142]: fig 2 ... implantable device 104 (medical device) transmitter/receiver 216 (a communication module comprising a transceiver configured to communicate ...) ... for example, communication devices such as implantable device 104 and external device 116 have to agree on many physical layer (multiple physical layers) and link layer aspects of the data to be exchanged ( ... configured to communicate ... with first and second receiving devices using a communication protocol that utilizes multiple physical layers) before a successful connection can be established and rules defining how to establish a connection and perform telemetry communications are referred to in wireless communication technology as "protocols" (... configured to communicate wirelessly with first and second receiving devices using a communication protocol that utilizes multiple physical layers) ... "non-proprietary telemetry communication technology or protocol" refers to any standardized telemetry communication technology or protocol ... using various non-proprietary telemetry protocols including but not limited to, BLUETOOTH, BLUETOOTH low energy (BLE), near field communication (NFC), Wireless Fidelity (Wi-Fi) protocol, Zigbee, RF4CE, WirelessHART, 6LoWPAN, Z-Wave,ANT, and the like (... configured to communicate wirelessly with first and second receiving devices using a communication protocol that utilizes multiple physical layers) [0030] ... the implantable device 104 and the external device 116 to communicate ... devices can establish a telemetry connection using a telemetry link and a "link" refers to a communications channel that connects two or more communicating devices and this link may be an actual physical link or it may be a logical link that uses one or more actual physical links. ... (see with fig 2 & [0030] above - a communication module comprising a transceiver configured to communicate wirelessly with first and second receiving devices using a communication protocol that utilizes multiple physical layers) [0031]).
Kivi did not explicitly disclose the transceiver configured with first and second physical layers (PHYs) for wireless communication.
Polo discloses the transceiver configured with first and second physical layers (PHYs) for wireless communication (Polo: fig 1-9, [0006-112]: fig 9 ... schematic block diagram of a wireless communication portion 100 of a wireless device ... wireless communication portion 900 includes a transmitter (TX) 901, a receiver (RX) 902, a local oscillator (LO) 907 and a baseband module 905. Baseband (a communication module comprising a transceiver configured to communicate wirelessly ...) [0087-88] ... fig 3 example of a BLE transceiver 300 ... BLE transceiver 300 includes a BLE module 310 ... operable to receive BLE signals (first physical layers (PHYs)) and/or BLE2 signals (second physical layers (PHYs)) and BLE module 310 may be enabled to decode and demodulate the received BLE/BLE2 signals and enabled to modulate and encode outbound BLE/BLE2 signals (transceiver configured with first and second physical layers (PHYs) for wireless communication) [0043-45]).
Kivi and Polo are analogous art because they are from the same field of endeavor with respect to wireless communication.
Before the effective filing date, for AIA , it would have been obvious to a person of ordinary skill in the art to incorporate the strategies by Polo into the device by Kivi. The suggestion/motivation would have been to provide Bluetooth modules implementing a BLE standard are often integrated into various types of mobile devices that are battery powered and managing power consumption associated with the Bluetooth modules as it pertains to battery life concerns in mobile devices (Polo: [0003]) and provide communication devices such as implantable device 104 and external device 116 have to agree on many physical layer and link layer aspects of the data to be exchanged (Kivi: [0030]).
Kivi and Polo further disclose one or more memories communicatively coupled with the one or more processors, the one or more sensors, and the communication module (Kivi: fig 1-10, [0014-142]: fig 2 ... implantable device 104 (medical device) memory 224 (one or more memories communicatively coupled with ...) processor 222 (one or more processors) transmitter/receiver 216 communication component 200 (communication module) ... other implantable device circuitry/software 220 ... electrical components can vary depending on the particular features and functionality of the implantable device 104 (medical device) and these electrical component can include, but are not limited to, one or more processors, memories, transmitters, receivers, transceivers, sensors (one or more sensors), sensing circuitry, therapy circuitry, antennas and other components [0044]), wherein the one or more memories comprise instructions to cause the one or more processors to:
determine one of the first and second PHYs to be utilized for at least one of data transmission or reception during the communication session with the one of the first and second receiving devices (Kivi: fig 1-10, [0014-142]: ... for example, communication devices such as implantable device 104 and external device 116 (... the one of the first and second receiving devices) have to agree on many physical layer (determine one of the first and second PHYs ...) and link layer aspects of the data to be exchanged ( ... to be utilized for at least one of data transmission or reception during the communication session with the one of the first and second receiving devices) before a successful connection can be established and rules defining how to establish a connection and perform telemetry communications are referred to in wireless communication technology as "protocols" [0030]);
initialize the communication session with one of the first and second receiving devices (Kivi: fig 1-10, [0014-142]: ...respective devices first establish a telemetry "connection" in order to communicate [0031] ... the connection request can specify or indicate a specific type of telemetry session to be performed between the implantable device 104 and the external device [0032]); and
manage the transceiver to utilize, during the communications session, the one of the first and second PHYs determined (Kivi: fig 1-10, [0014-142]: for example, communication devices such as implantable device 104 and external device 116 have to agree on many physical layer (... the one of the first and second PHYs determined) and link layer aspects of the data to be exchanged ( ... to utilize, during the communications session, the one of the first and second PHYs determined) before a successful connection can be established and rules defining how to establish a connection and perform telemetry communications are referred to in wireless communication technology as "protocols" [0030];
Polo: fig 1-9, [0006-112]: fig 9 ... schematic block diagram of a wireless communication portion 100 of a wireless device ... wireless communication portion 900 includes a transmitter (TX) 901, a receiver (RX) 902, a local oscillator (LO) 907 and a baseband module 905. Baseband (manage the transceiver to utilize..) [0087-88] ... fig 3 example of a BLE transceiver 300 ... BLE transceiver 300 includes a BLE module 310 ... operable to receive BLE signals (first physical layers (PHYs)) and/or BLE2 signals (second physical layers (PHYs)) and BLE module 310 may be enabled to decode and demodulate the received BLE/BLE2 signals and enabled to modulate and encode outbound BLE/BLE2 signals (... during the communications session, the one of the first and second PHYs determined) [0043-45]), wherein at least one of:
i) the medical device is an implantable medical device configured to be implantable subcutaneously (Kivi: fig 1-10, [0014-142]: ... medical device telemetry system 100 includes an implantable device 104 implanted within a body 102, and an external device 116 [0024]) or
ii) the one or more sensors comprise an analyte sensor configured a) to be at least partially implantable to collect an analyte generated by the body and b) to generate the signals corresponding to levels of the analyte in the body.
Same motivation applies as mentioned above to make the proposed modification.
As to claim 2, Kivi and Polo disclose determine one of the first and second receiving devices to maintain a communications session with based on at least one of i) a measure of signal or link quality, ii) a measure of priority of communications or iii) which PHY are supported by the first and second receiving devices (Kivi: fig 1-10, [0014-142]: fig 2 ... the telemetry session management component 204 can also include prediction component 214 to facilitate predicting stall events based on the monitored uplink throughput information (a measure of signal or link quality) ... a threshold of change in uplink throughput that corresponds to a sharp drop can be defined and defined characteristics can include a pattern in the monitored uplink throughput data that indicates the onset of degradation in quality of the telemetry session (a measure of signal or link quality) [0072] ... the communication component 200 can access information stored in memory 224 that identifies a priority classification associated with different types of data and transmit data having a higher priority classification before transmission of data having a lower priority classification (a measure of priority of communications) [0074] ... for example, communication devices such as implantable device 104 and external device 116 have to agree on many physical layer (which PHY are supported by the first and second receiving devices) and link layer aspects of the data to be exchanged before a successful connection can be established and rules defining how to establish a connection and perform telemetry communications are referred to in wireless communication technology as "protocols" (which PHY are supported by the first and second receiving devices) [0030];
Polo: fig 1-9, [0006-112]: ... BLE transceiver 300 is configured to switch between BLE and BLE2 connections ... initiator and/or the scanner devices may be ... multi-mode devices e.g., support both BLE and BLE2 activities ... [0053] ... BLE transceiver 300 is configured to switch from a first Bluetooth wireless communication mode ( e.g., legacy BLE) to a second Bluetooth wireless communication mode e.g., BLE2 based on the modulation type " (which PHY are supported by the first and second receiving devices) and the second Bluetooth wireless communication mode may be associated with a data rate ( e.g., 2 Mbps) that is greater than the data rate (e.g., 1 Mbps) associated with the first Bluetooth wireless communication mode [0054]).
For motivation, see rejection of claim 1.
As to claim 3, Kivi and Polo disclose wherein the one of the first and second PHYs is determined based on a need of a given communication session or communication environment (Polo: fig 1-9, [0006-112]: ... devices that need to form a connection to another device listen for connectable advertising packets are referred to as initiators ( ... based on a need of a given communication session or communication environment) and upon receipt of advertising packets from advertisers e.g., advertiser 220 the initiator 240 may be enabled to determine specific advertisers to which a connection request (CONNECT_REQ) packet may be transmitted ... initiator 240 may be configured to process advertising packets from advertisers in the white list that may include a list recorded with device class bits for preferred BLE2 devices and/or legacy BLE devices (wherein the one of the first and second PHYs is determined based on a need of a given communication session or communication environment) [0034] ... the BLE transceiver 300 is configured to switch between BLE and BLE2 connections (see with [0034] above - wherein the one of the first and second PHYs is determined ...) ... initiator and/or the scanner devices may be ... multi-mode devices e.g., support both BLE and BLE2 activities ... [0053] ... BLE transceiver 300 is configured to switch from a first Bluetooth wireless communication mode ( e.g., legacy BLE) to a second Bluetooth wireless communication mode ( e.g., BLE2) based on the modulation type " (see with [0034] above ... based on a need of a given communication session or communication environment) and the second Bluetooth wireless communication mode may be associated with a data rate ( e.g., 2 Mbps) that is greater than the data rate (e.g., 1 Mbps) associated with the first Bluetooth wireless communication mode [0054]).
For motivation, see rejection of claim 1.
As to claim 4, see similar rejection to claims 2-3 where the device is taught by the device.
As to claims 11-14 , see similar rejection to claims 1-4, respectively where the method is taught by the device.
Claims 5-7, 10, 15-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2019/0070423 to Kivi et al. (“Kivi”) in view of U.S. Patent Publication No. 2014/0086125 to Polo et al. (“Polo”) and further in view of U.S. Patent Publication No. 2012/0016305 to Jollota et al. (“Jollota”).
As to claim 5, Kivi and Polo disclose the device of claim 1.
For motivation, see rejection of claim 1.
Kivi did not explicitly disclose wherein the one of the first and second receiving devices is determined based on the measure of priority of communications, the measure of priority of communications representing a prioritization of connecting and sending an alarm message to the first receiving device which is in a specific subset of receiving devices
Jollota discloses wherein the one of the first and second receiving devices is determined based on the measure of priority of communications (Jollota: fig 1-42, [0011-296]: ... wireless telemetry router 1500 may receive a first wireless communication signal from a first sensor transmitter 1502a, receive a second wireless communication signal from a second sensor transmitter 1502b, obtain or extract the two respective sensor identifiers (which should be different), and process the sensor data conveyed in the two wireless communication signals in a synchronized manner that is determined, governed, or dictated by the sensor identifiers and this enables wireless telemetry router 1500 to prioritize the receipt, processing, storage, and/or transmission of sensor data depending upon the originating source (wherein the one of the first and second receiving devices is determined based on the measure of priority of communications) [0192] ... wireless telemetry router 1500 may, for example, maintain or access a lookup table that contains the different sensor identifiers and a corresponding list of destination network identifiers for each sensor identifier and lookup table may also include corresponding processing instructions for each sensor identifier [0193] ... for example, a particular wireless data communication mode may be selected in response to: (1) a priority associated with data to be transferred between the devices ... a reliable link mode can be selected for data marked with a relatively high priority, while unreliable link mode can be selected for data marked with a relatively low priority [0263]),
the measure of priority of communications representing a prioritization of connecting and sending an alarm message to the first receiving device which is in a specific subset of receiving devices (Jollota: fig 1-42, [0011-296]: ... If the devices are currently operating in the reliable link mode, then an appropriate alarm is generated (task 2514) (see with [0193;263] above - the measure of priority of communications representing a prioritization of connecting and sending an alarm message to the first receiving device ...) [0265] ... it may be desirable for a device to communicate with only a subset of the devices within the network and fig 31 is a diagram that depicts two subnetworks of wireless medical devices in a medical device network, in this simplified example, subnetwork one includes monitor/controller 2202, physiological sensor transmitter 2204, and bedside monitor 2206, and subnetwork two includes monitor/controller 2202 and BG meter 2208 and each device may be associated with one or more codes or suitably formatted subnetwork indicators that identify the different subnetworks to which that device belongs (see with [0193;263;265] above - ... the first receiving device which is in a specific subset of receiving devices) and, in this example, monitor/controller 2202 would have two different subnetwork identifiers [0237]).
Kivi, Polo and Jollota are analogous art because they are from the same field of endeavor with respect to wireless communication.
Before the effective filing date, for AIA , it would have been obvious to a person of ordinary skill in the art to incorporate the strategies by Jollota into the device by Kivi and Polo. The suggestion/motivation would have been to provide wireless data communication features suitable for use in a medical device network environment (Jollota: [0002]).
As to claim 6, Kivi, Polo and Jollota disclose herein the first PHY is more power efficient or supports a longer range than the second PHY, the one of the first and second receiving devices determined based on which of the first and second PHYs are supported by the first and second receiving devices (Polo: fig 1-9, [0006-112]: ... BLE transceiver 300 is configured to switch from a first Bluetooth wireless communication mode e.g., legacy BLE to a second Bluetooth wireless communication mode e.g., BLE2 based on the modulation type (the one of the first and second receiving devices determined based on which of the first and second PHYs are supported by the first and second receiving devices) and the second Bluetooth wireless communication mode may be associated with a data rate e.g., 2 Mbps (the first PHY is more power efficient since faster data rate) that is greater than the data rate e.g., 1 Mbps associated with the first Bluetooth wireless communication mode [0054] ... to support link layer control of BLE2 activities, link layer control protocol data units (PDU) may have a vendor specific format and, in this regard, messages may be kept in the vendor specific format to provide for interoperation with legacy BLE systems and the messages are utilized to detect and switch from BLE to BLE2 and vice-versa (the one of the first and second receiving devices determined based on which of the first and second PHYs are supported by the first and second receiving devices) [0055]).
For motivation, see rejection of claim 5.
As to claim 7, Kivi, Polo and Jollota disclose wherein the transceiver is configured to establish one or more simultaneous communications sessions with the first and second receiving devices (Jollota: fig 1-42, [0011-296]: ... it may be possible for a wireless medical device (wherein the transceiver is configured to ...) to perform a broadcast transmission of data packets for potential reception by a plurality of destination devices (... establish one or more simultaneous communications sessions with the first and second receiving devices) in the network [0239];
Polo: fig 1-9, [0006-112]: ... physical link may be used as a transport for one or more logical links that support (wherein the transceiver is configured to ...) unicast synchronous, asynchronous and isochronous traffic, and broadcast traffic (... establish one or more simultaneous communications sessions with the first and second receiving devices) [0064]).
For motivation, see rejection of claim 5.
As to claim 10, Kivi, Polo and Jollota disclose enter a dormant state, preserving battery, during which the one or more sensors do not detect signals corresponding to one or more physiological signals (Jollota: fig 1-42, [0011-296]: ... one example of a dynamically switchable wireless link is the wireless link between an infusion pump and a bedside monitor for the pump and although this link may be a reliable link while the patient is asleep and in close proximity to the bedside monitor, during the day the link could switch to a best effort link (enter a dormant state, preserving battery) to accommodate periods of time when the patient might be outside of the reliable range of the bedside monitor (during which the one or more sensors do not detect signals corresponding to one or more physiological signals) and when the patient (and the infusion pump) [0262]);
in response to receiving an activation command, transition to an active state and begin detection of the signals corresponding to one or more physiological signals (Jollota: fig 1-42, [0011-296]: ... and when the patient (and the infusion pump) returns within range of the bedside monitor (in response to receiving an activation command ...) the link can switch back to a reliable link (transition to an active state) and accumulated patient data can be transferred in a batch mode (and begin detection of the signals corresponding to one or more physiological signals) [0262]).
For motivation, see rejection of claim 5.
As to claims 15-17 and 20 , see similar rejection to claims 5-7 and 10, respectively where the method is taught by the device.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
A) US 20240022636 Kanteti
Techniques and protocols for enhancing wireless communications between an analyte sensor system and one or more other devices are described. Such techniques may include, for example, dynamic adjustment of transmission power when transmitting invitations, transmitting invitations with alternate (or different) payloads during different invitation periods, a reduction of handshake messages (e.g., client characteristic configuration descriptor (CCCD) messaging), etc. The various enhancements described herein may relate to various aspects of wireless communication protocols, including, for example, authentication, connection protocols, invitation message structure and content, device pairing, data transmission, etc.
B) US 20240207622 – Huegerich
A communication system for establishing an intra-body communication comprises a multiplicity of implantable medical devices, each of the multiplicity of implantable medical devices comprising communication circuitry for communicating with another of the multiplicity of implantable medical devices using a first signaling technique. At least one external device comprises first communication circuitry for communicating with the multiplicity of implantable medical devices using said first signaling technique and second communication circuitry for communicating with a remote system using a second signaling technique different than the first signaling technique.
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/JUNE SISON/Primary Examiner, Art Unit 2455