DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In response to amendments, filed June 18, 2025, claims 1, 10-11, 14, and 19-20 have been amended. No claims have been cancelled. No claims have been added. Claims 1-20 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed June 18, 2025, with respect to 35 USC 112 have been fully considered and are persuasive. The rejections with respect to 35 USC 112 has been withdrawn.
Applicant's arguments with regard to the prior art rejections have been fully considered but they are not persuasive.
In response to Applicant’s argument that Wedekind fails to teach transmitting sensor context information, by the first application on the first remote device, and in response to receiving an indication through a user interface that the user wishes to switch devices, to a second application on a second remote device, Examiner respectfully disagrees.
It is noted that the features upon which applicant relies (i.e., receiving an indication through a user interface that the user wishes to switch devices) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Still, Wedekind does disclose this unclaimed limitation in [0101], “a user may want to use Display Device 20C and uses Display Device 20A to send over the pairing information.” All the previously presented and currently amended limitations of claims 1-20 are anticipated by or unpatentable over combinations of Wedekind and Sloan.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-12 and 14-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wedekind (US 20200008721 A1).
Regarding claim 1, Wedekind teaches a method of wirelessly communicating data in an analyte monitoring system ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), the method comprising:
causing, by a first application on a first remote device, activation of a sensor control device by using a first wireless communication protocol; establishing a first wireless communication link between the sensor control device and the first remote device according to a second wireless communication protocol ([0011] after the sensor electronics unit wakes, it can pair and communicate using the first communication protocol with the display device that was used to wake the sensor electronics unit. Similarly, the second communication protocol can be used to change the mode of operation of the sensor electronics unit, such as changing it to shelf mode, idle mode, low power mode, normal mode, high speed mode, and/or any mode that may be desirable for the sensor electronics unit.);
transmitting, by the sensor control device, a first set of sensor data to the first remote device via the first wireless communication link ([0012] The sensor electronics unit may communicate data indicative of analyte levels, such as analyte measurement data or estimated analyte values, to the display device using at least one of the plurality of communication protocols);
transmitting sensor context information, by the first application on the first remote device, and in response to a system-detected condition associated with a transition to the second remote device, transmitting sensor context information that enables the second remote device to resume wireless communication with the sensor control device, to a second application on a second remote device ([0101] Over Communication Channel 259, Display Devices 20A,C can utilize any communication protocol described in this disclosure… Display Devices 20A,C can transmit data [e.g., estimated blood glucose levels, pairing information, information about a Sensor Electronics Unit 6, calibration information, timing information [e.g., time synchronizations, EGV data with time stamps, etc.], raw sensor data, system status information, detected faults, alerts, clocking information, device manufacturing ID, and/or any other data and/or information described in this disclosure], commands/requests [e.g., data requests, synchronization requests, pairing requests], etc. to one another… a user may want to use Display Device 20C and uses Display Device 20A to send over the pairing information; Fig. 2B);
deactivating, by the first application on the first remote device, the first wireless communication link ([0218] FIG. 9C illustrates an example white list and bonding list being updated when Sensor Electronics Unit 6 and Display Device 20A are unpaired using the second communication protocol. Advantageously, using a second communication protocol, such as an RF field [e.g., NFC or RFID], can allow a user to remove Display Device 20A [or any other display device, such as Display Device 20C] from a white list [e.g., White List 906] dynamically and on-demand.); and
establishing a second wireless communication link between the sensor control device and the second remote device according to the second wireless communication protocol (Fig. 2A; Fig. 2B; [0099] Sensor Electronics Unit 6 is communicatively coupled to a plurality of Display Devices 20A-N using a plurality of Communication Channels 106A-N, 108A-N. [0100] Communication Channels 106A-N each can use a first communication protocol, such as a radio transmission like BLUETOOTH®, and Communication Channels 108A-N can each use a second, different communication protocol, such as an RF field like NFC or RFID).
Regarding claim 2, Wedekind teaches the method of claim 1 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), further comprising transmitting, by the sensor control device, a second set of sensor data to the second remote device via the second wireless communication link ([0091] In Block 66, the Sensor Electronics Unit 6 can connect to the one or more Display Devices 20A-N and transmit/receive communications in a transmission cycle, where Sensor Electronics Unit 6 sends relevant data [e.g., analyte data] to the one or more Display Devices 20A-N.).
Regarding claim 3, Wedekind teaches the method of claim 1 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), wherein causing activation of the sensor control device further comprises causing the sensor control device to autonomously transmit data according to the second wireless communication protocol ([0097] Communication Channel 106 can utilize RF fields, such as, without limitation, NFC or RFID. Communication Channel 108 can utilize radio transmission, such BLUETOOTH®. In the case where Communication Channel 106 is NFC or and Communication Channel 108 is BLUETOOTH®, NFC or RFID can provide some advantages over BLUETOOTH®, including, without limitation, having little interference in crowds, ease of use, automatic pairing when in proximity, lower power usage, and others. Similarly, BLUETOOTH® can have advantages over NFC or RFID such as high speed of data transmission, increased range, autonomous communications with multiple different devices, automatically scheduled transmissions and others.).
Regarding claim 4, Wedekind teaches the method of claim 3 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), wherein causing activation of the sensor control device further comprises causing the sensor control device to autonomously transmit data according at a predetermined transmission rate (Fig. 1B; [0089] In Block 62, the Sensor Electronics Unit 6 can pair with one or more Display Devices 20A-N; [0091] In Block 66, the Sensor Electronics Unit 6 can connect to the one or more Display Devices 20A-N and transmit/receive communications in a transmission cycle, where Sensor Electronics Unit 6 sends relevant data [e.g., analyte data] to the one or more Display Devices 20A-N. As an example illustration, and without limitation, the Sensor Electronics Unit 6 and the Display Devices 20A-N can be connected during the transmission cycle using the following procedures. The Sensor Electronics Unit 6 can periodically advertise at predetermined time intervals, such as every 5, 10, 15, and/or any number of minutes as desired. The advertisement window can be anywhere from 7 seconds to 22 seconds. [0066] one or more display devices are configured to query the sensor electronics unit for sensor information, where the display device requests sensor information from the sensor electronics unit in an on-demand fashion, such as, without limitation, in response to a query. In some implementations, the sensor electronics unit can be configured for periodic, systematic, regular, irregular or aperiodic transmission of sensor information to one or more display devices [e.g., every 1, 2, 5, or 10 minutes or more]).
Regarding claim 5, Wedekind teaches the method of claim 1 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), wherein transmitting sensor context information to the second remote device is performed by the first remote device ([0101] a user can pair Display Device 20A with Sensor Electronics Unit 6. Subsequently, the pairing information [e.g., timing information, encryption key, authentication information, advertising parameters, address, make/model, name, GAP, IRK, and/or any other relevant information for pairing] of Sensor Electronics Unit 6 can be sent to Display Device 20C from Display Device 20A directly; Communication Channel 259).
Regarding claim 6, Wedekind teaches the method of claim 1 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), wherein transmitting sensor context information to the second remote device is performed by the sensor control device ([0089] In Block 62, the Sensor Electronics Unit 6 can pair with one or more Display Devices 20A-N. In order to pair with display devices, the Sensor Electronics Unit 6 can first advertise [e.g., broadcasting to display devices for connection] to pair with display devices... Any Display Devices 20A-N receiving the advertisement can send a connection request to the sensor electronics device 6. The Sensor Electronics Unit 6 and the Display Devices 20A-N can then proceed with the appropriate steps to pair using the communication protocol used [e.g., authentication, connection, encryption/decryption, exchanging data, etc.]).
Regarding claim 7, Wedekind teaches the method of claim 1 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), wherein the first remote device comprises a first smartphone (Display Device 20C; [0068] a plurality of display devices [e.g., a custom analyte monitoring device, a mobile phone, a tablet, a smart watch, a reference analyte monitor, a medicament delivery device, a medical device and a personal computer] may be configured to wirelessly communicate with the sensor electronics unit).
Regarding claim 8, Wedekind teaches the method of claim 7 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), wherein the second remote device comprises a second smartphone ([0079] FIG. 2A, Continuous Analyte Monitoring System 1 can have any number of Display Devices 20A-N. [0068] a plurality of display devices [e.g., a custom analyte monitoring device, a mobile phone, a tablet, a smart watch, a reference analyte monitor, a medicament delivery device, a medical device and a personal computer] may be configured to wirelessly communicate with the sensor electronics unit).
Regarding claim 9, Wedekind teaches the method of claim 1 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), wherein the first wireless communication protocol comprises a Near Field Communication (NFC) protocol ([0008] A second communication protocol can utilize a radio frequency [“RF”] field, such as near field communication [“NFC”] or radio frequency identification [“RFID”]. NFC can be an RF field with a 13.56 MHz frequency).
Regarding claim 10, Wedekind teaches the method of claim 1 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), wherein the second wireless communication protocol comprises a standard communication protocol ([0008] a first communication protocol can utilize radio transmission, such as BLUETOOTH®, or Bluetooth Low Energy [BLE] wireless communication protocol, which uses a radio transmission frequency range 2.4 to 2.485 GHz).
Regarding claim 11, Wedekind teaches an analyte monitoring system ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), comprising:
a sensor control device (Sensor Electronics Unit 6) comprising:
first communication circuitry configured to communicate data according to a first wireless communication protocol, second communication circuitry configured to communicate data according to a second wireless communication protocol ([0107] Communicators 305 can utilize a communication protocol configured to send and/or receive data over communication channels. For example, and without limitation, such communication protocols can include BLUETOOTH®, IBEACON®, ZIGBEE®, Wi-Fi, induction wireless data transmission, radio frequencies, radio transmission, RF fields, RFID, NFC, GSM, infrared, Ethernet cables, coaxial cables, USB, firewire, data lines, wire, and/or any wired and/or wireless connection known in the art. For example, and without limitation, Communicators 305 can include an antenna, inductor, signal line, ground line, and/or any other electronics used for sending/receiving data. In the case of NFC, RFID, and/or substantially similar technologies, Communicators 305 can include readers, writers, and/or tags; Communication channels 106 and 108; Fig. 3), and
an analyte sensor at least a portion of which is configured to be in fluid contact with a bodily fluid of a subject ([0083] Continuous Analyte Sensor 8 can be, for example and without limitation, a subcutaneous, transdermal [e.g., transcutaneous], or intravascular device);
a first remote device (display device 20A, Fig. 4A), comprising:
wireless communication circuitry (communicators 405), one or more processors coupled with a memory (controller 401, memory 402), the memory storing instructions that, when executed by the one or more processors ([0116] Controller 401 can perform logical and arithmetic operations based on program instructions stored within Memory 402. Controller 401 can include one or more processors [e.g., microprocessors] and other peripherals), cause the one or more processors to:
activate the sensor control device using the first wireless communication protocol, establish a wireless communication link with the sensor control device according to a second wireless communication protocol ([0011] after the sensor electronics unit wakes, it can pair and communicate using the first communication protocol with the display device that was used to wake the sensor electronics unit. Similarly, the second communication protocol can be used to change the mode of operation of the sensor electronics unit, such as changing it to shelf mode, idle mode, low power mode, normal mode, high speed mode, and/or any mode that may be desirable for the sensor electronics unit.),
receive, from the sensor control device, and process sensor data ([0012] The sensor electronics unit may communicate data indicative of analyte levels, such as analyte measurement data or estimated analyte values, to the display device using at least one of the plurality of communication protocols; [0064] a display device is configured to display the sensor information via a downloadable program [e.g., a downloadable Java Script via the internet and/or a mobile application downloaded from an entity that created and/or owns and/or licenses the app, and/or an app store such as from APPLE, INC. or GOOGLE INC., or other companies] … can be configured to display displayable sensor information [e.g., mobile devices, smartphones, tablets, personal digital assistants, personal computers, and the like]),
in response to detecting a condition associated with transitioning to a second remote device, transmitting sensor context information from the first application to a second application on the second remote device, to facilitate resumption of wireless communication with the sensor control device, ([0101] Over Communication Channel 259, Display Devices 20A,C can utilize any communication protocol described in this disclosure. By way of illustrative example, and without limitation, Display Devices 20A,C can communicate with each other using an RF field such as NFC or RFID. For example, using NFC or RFID, Display Devices 20A,C can transmit data [e.g., estimated blood glucose levels, pairing information, information about a Sensor Electronics Unit 6, calibration information, timing information [e.g., time synchronizations, EGV data with time stamps, etc.], raw sensor data, system status information, detected faults, alerts, clocking information, device manufacturing ID, and/or any other data and/or information described in this disclosure], commands/requests [e.g., data requests, synchronization requests, pairing requests], etc. to one another… a user may want to use Display Device 20C and uses Display Device 20A to send over the pairing information.; Fig. 2B), and
deactivating the wireless communication link with the sensor control device ([0218] FIG. 9C illustrates an example white list and bonding list being updated when Sensor Electronics Unit 6 and Display Device 20A are unpaired using the second communication protocol. Advantageously, using a second communication protocol, such as an RF field [e.g., NFC or RFID], can allow a user to remove Display Device 20A [or any other display device, such as Display Device 20C] from a white list [e.g., White List 906] dynamically and on-demand.).
Regarding claim 12, Wedekind teaches the analyte monitoring system of claim 11 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), wherein the sensor context information comprises one or more of sensor activation information, public keys, private keys, and remaining sensor life information ([0101] pairing information [e.g., timing information, encryption key, authentication information, advertising parameters, address, make/model, name, GAP [Generic Access Profile], IRK [Identity Resolving Key], and/or any other relevant information for pairing]).
Regarding claim 14, Wedekind teaches the analyte monitoring system of claim 11 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), wherein the instructions further comprise transmitting the sensor context information to the second remote device according to a standard communication protocol ([0100] Communication between each of Display Devices 20A-N can also use any of the communication protocols described in this disclosure, including radio transmission [e.g., BLUETOOTH®] or RF fields [e.g., NFC or RFID]; [0101] Display Devices 20A,C can transmit data [e.g., estimated blood glucose levels, pairing information, information about a Sensor Electronics Unit 6, calibration information, timing information [e.g., time synchronizations, EGV data with time stamps, etc.], raw sensor data, system status information, detected faults, alerts, clocking information, device manufacturing ID, and/or any other data and/or information described in this disclosure], commands/requests [e.g., data requests, synchronization requests, pairing requests], etc. to one another).
Regarding claim 15, Wedekind teaches the analyte monitoring system of claim 11 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), wherein the instructions further comprise instructions to output the processed sensor data to a display of the first remote device ([0188] Display Device 20 can send Transmission 732 to Sensor Electronics Unit 6 to send recent data. Sensor Electronics Unit 6 can then return data to Display Device 20 using the second communication protocol; [0064] The sensor information [e.g., data, measurements, etc.] may comprise processed and/or transformed sensor information that does not require processing by the display device prior to display of the sensor information. However, some display devices may comprise software including display instructions [e.g., software programming comprising instructions configured to display the sensor information and optionally query the sensor electronics unit to obtain the sensor information] configured to enable display of the sensor information thereon.).
Regarding claim 16, Wedekind teaches the analyte monitoring system of claim 11 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), wherein the first remote device comprises a first smartphone (Display Device 20C; [0068] a plurality of display devices [e.g., a custom analyte monitoring device, a mobile phone, a tablet, a smart watch, a reference analyte monitor, a medicament delivery device, a medical device and a personal computer] may be configured to wirelessly communicate with the sensor electronics unit).
Regarding claim 17, Wedekind teaches the analyte monitoring system of claim 16 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), wherein the second remote device comprises a second smartphone ([0079] FIG. 2A, Continuous Analyte Monitoring System 1 can have any number of Display Devices 20A-N. [0068] a plurality of display devices [e.g., a custom analyte monitoring device, a mobile phone, a tablet, a smart watch, a reference analyte monitor, a medicament delivery device, a medical device and a personal computer] may be configured to wirelessly communicate with the sensor electronics unit).
Regarding claim 18, Wedekind teaches the analyte monitoring system of claim 11 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), wherein the first wireless communication protocol comprises a Near Field Communication (NFC) protocol (Fig. 2A; Fig. 2B; [0099] Sensor Electronics Unit 6 is communicatively coupled to a plurality of Display Devices 20A-N using a plurality of Communication Channels 106A-N, 108A-N. [0100] Communication Channels 108A-N can each use a second, different communication protocol, such as an RF field like NFC or RFID).
Regarding claim 19, Wedekind teaches the analyte monitoring system of claim 11 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), wherein the second wireless communication protocol comprises a standard communication protocol (Fig. 2A; Fig. 2B; [0099] Sensor Electronics Unit 6 is communicatively coupled to a plurality of Display Devices 20A-N using a plurality of Communication Channels 106A-N, 108A-N. [0100] Communication Channels 106A-N each can use a first communication protocol, such as a radio transmission like BLUETOOTH®).
Regarding claim 20, Wedekind teaches a method of wirelessly communicating data in an analyte monitoring system ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system), the method comprising:
establishing a first wireless communication link between a sensor control device and a first remote device (Fig. 2A; Fig. 2B; [0099] Sensor Electronics Unit 6 is communicatively coupled to a plurality of Display Devices 20A-N using a plurality of Communication Channels 106A-N, 108A-N. [0100] Communication Channels 106A-N each can use a first communication protocol, such as a radio transmission like BLUETOOTH®);
transmitting, by the sensor control device, a first set of sensor data to the first remote device via the first wireless communication link ([0091] In Block 66, the Sensor Electronics Unit 6 can connect to the one or more Display Devices 20A-N and transmit/receive communications in a transmission cycle, where Sensor Electronics Unit 6 sends relevant data [e.g., analyte data] to the one or more Display Devices 20A-N; [0100] Communication Channels 106A-N each can use a first communication protocol, such as a radio transmission like BLUETOOTH®; [0015] cause the sensor electronics unit to transmit analyte measurement data or estimated analyte values using the first communication protocol);
transmitting sensor context information to a second remote device in response to detecting a condition associated with transitioning to the second remote device, and wherein the sensor context information comprises one or more of sensor activation information, public keys, private keys, remaining sensor life information, and a user ID ([0101] a user can pair Display Device 20A with Sensor Electronics Unit 6. Subsequently, the pairing information [e.g., timing information, encryption key, authentication information, advertising parameters, address, make/model, name, GAP, IRK, and/or any other relevant information for pairing] of Sensor Electronics Unit 6 can be sent to Display Device 20C from Display Device 20A directly; Communication Channel 259… a user may want to use Display Device 20C and uses Display Device 20A to send over the pairing information; Fig. 2B);
deactivating the first wireless communication link ([0218] FIG. 9C illustrates an example white list and bonding list being updated when Sensor Electronics Unit 6 and Display Device 20A are unpaired using the second communication protocol. Advantageously, using a second communication protocol, such as an RF field [e.g., NFC or RFID], can allow a user to remove Display Device 20A [or any other display device, such as Display Device 20C] from a white list [e.g., White List 906] dynamically and on-demand.); and
establishing a second wireless communication link between the sensor control device and the second remote device (Fig. 2A; Fig. 2B; [0099] Sensor Electronics Unit 6 is communicatively coupled to a plurality of Display Devices 20A-N using a plurality of Communication Channels 106A-N, 108A-N. [0100] Communication Channels 106A-N each can use a first communication protocol, such as a radio transmission like BLUETOOTH®).
Claim Rejections - 35 USC § 103
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.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wedekind (US 20200008721 A1) in view of Sloan (US 20180007139 A1).
Regarding claim 13, Wedekind teaches the analyte monitoring system of claim 11 ([0002] systems and methods for communications between a sensor electronics unit and a display device of an analyte monitoring system). However, Wedekind fails to explicitly disclose wherein the sensor context information comprises a user ID.
Sloan teaches management of multiple devices within an analyte monitoring environment. Sloan discloses wherein the sensor context information comprises a user ID ([0073] the data collected by the reader device operator for each user is associated to that user with a user identifier, or user ID. The user identifier can be any string of characters that uniquely identifies the user.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Wedekind to include a user ID as disclosed in Sloan to collect analyte data from multiple users where each user's data is associated with a user identifier (Sloan [0074]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOLLY HALPRIN whose telephone number is (703)756-1520. The examiner can normally be reached 12PM-8PM ET.
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791