Prosecution Insights
Last updated: October 02, 2026
Application No. 18/674,617

ANALYTE MONITORING DEVICE AND CONTROLLING METHOD THEREOF

Final Rejection §102§103§112
Filed
May 24, 2024
Priority
Jun 01, 2023 — RE 10-2023-0070642
Examiner
YOON, CHANEL J
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
i-SENS Inc.
OA Round
2 (Final)
55%
Grant Probability
Moderate
3-4
OA Rounds
1y 1m
Est. Remaining
95%
With Interview

Examiner Intelligence

Grants 55% of resolved cases
55%
Career Allowance Rate
120 granted / 218 resolved
-15.0% vs TC avg
Strong +40% interview lift
Without
With
+40.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
58 currently pending
Career history
274
Total Applications
across all art units

Statute-Specific Performance

§101
17.4%
-22.6% vs TC avg
§103
36.9%
-3.1% vs TC avg
§102
14.5%
-25.5% vs TC avg
§112
28.3%
-11.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 218 resolved cases

Office Action

§102 §103 §112
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 . Amendment Entered In response to the amendment filed on June 22nd, 2026, amended claims 1-16 are entered. Response to Arguments Applicant's remarks and amendments with respect to the claim objections have been fully considered. The objections are withdrawn in view of the amendment. Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment. Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 102 and 103 have been considered but are not persuasive. The rejections have been maintained and further clarified in view of the amendments. At Pgs. 8-9 of the Reply, Applicant argues that Van Tassel fails to disclose the newly amended limitations. Examiner respectfully disagrees. Although the exact language differs, Van Tassel still reads on the current claim limitations, as clarified below. Furthermore, the Examiner notes that there are no specific requirements for the first and second “authorizations” and that the claim limitations are being interpreted as best understood, in view of the current rejections under 35 U.S.C. 112(a) and 112(b). Van Tassel discloses an analyte monitoring device (System and method for wireless communication of analyte data; Abstract; [0036]) comprising: an analyte sensor of which at least a portion is configured to be located under a skin of a user and detects an analyte signal related to a glucose concentration (With reference to FIG. 1A, in some embodiments, analyte sensor 10 includes a continuous glucose sensor, for example, a subcutaneous, transdermal (e.g., transcutaneous), or intravascular device; [0162]; Figure 1A); a communication interface including at least one communication circuit (connectivity interface 355; transceiver 360; [0233]; [0238-0239]; Figure 3B); a memory storing at least one instruction (storage 365; [0230-0233]; [0238]; Figure 3B); and at least one processor (processor 380; [0230]; [0239]; Figure 3B), wherein the at least one processor executes the at least one instruction to: periodically activate the communication interface at a predetermined first time interval (As will be further described below, there can be a process for initially establishing communication between display device 310 and the sensor electronics module, e.g., sensor electronics module 12, when the module is first used or re-activated (e.g., the battery is replaced); [0195]; [0325]; Block 1502 includes preconfiguring an analyte sensor system to periodically wake from a low-power passive monitoring mode according to a predetermined interval for waking the analyte sensor system; [0335-0336]); perform a first authentication for a wake-up signal for waking up the analyte monitoring device when the wake-up signal is received from a user terminal device through the activated communication interface (Block 1504 includes receiving a wake signal from a display device before expiration of the predetermined interval while in the low-power passive monitoring mode, thereby causing the analyte sensor system to wake before expiration of the predetermined interval. For example, analyte sensor system 1408 can receive wake signal 1412 from display device 1410 before expiration of the predetermined interval while in the low-power passive monitoring mode, thereby causing analyte sensor system 1408 to wake before expiration of the predetermined interval; [0336]); when the first authentication is successful, establish a communication channel the user terminal by: transmitting an advertising message for a pairing process in response to successful completion of the first authentication (Block 1506 includes transmitting an advertisement message in response to the wake signal. For example, analyte sensor system 1408 can be configured to exit the low-power passive monitoring mode and transmit advertisement message 1414 in response to receiving wake signal 1408; [0337]; 1506 in Figure 15A; [0337]); performing a second authentication for identification information for pairing received from the user terminal device in response to the advertising message (Block 1508 includes receiving a pairing request from the display device. For example, analyte sensor system 1408 can be configured to receive pairing request 1416 from display device 1410; [0338]); and establishing the communication channel upon successful completion of the second authentication (Block 1510 includes transmitting a pairing request acceptance message to the display device. For example, analyte sensor system 1408 can be configured to transmit pairing request acceptance message 1418 to display device 1410; [0339]); and transmit information related to the analyte signal to the user terminal device at a predetermined second time interval through the communication channel (Block 1512 includes transmitting sensor data to the display device. For example, analyte sensor system 1408 can be configured to enter a secure sensor communication session based on the above communications in which analyte sensor system 1408 can transmit data, e.g., sensor data, to display device 1410. In some embodiments, transmission of such sensor data can comprise fulfilling a backfill request for specific data from display device 1410 and/or any other data at a time before a predetermined interval for waking analyte sensor system 1408 has expired; [0340]). Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites “when the first authentication is successful, establish a communication channel with the user terminal device by: transmitting an advertising message for a pairing process in response to successful completion of the first authentication; performing a second authentication for identification information for pairing received from the user terminal device in response to the advertising message; and establishing the communication channel upon successful completion of the second authentication” in lines 12-20. However, the Applicant’s Specification does not provide sufficient support for the newly added limitations of “when the first authentication is successful, establish a communication channel with the user terminal device by: transmitting an advertising message for a pairing process in response to successful completion of the first authentication; performing a second authentication for identification information for pairing received from the user terminal device in response to the advertising message; and establishing the communication channel upon successful completion of the second authentication”. Although the Applicant’s Specification recites wherein “the analyte monitoring device 100 may enter the second mode to transmit an advertising packet to a peripheral device. The second mode may be an advertising mode. The advertising mode may refer to a mode in which the analyte monitoring device 100 periodically transmits the advertising signal to the outside for communication connection with the external device such as the user terminal device 200. In the advertising mode, the analyte monitoring device 100 may perform broadcasting to identify the user terminal device 200. The analyte monitoring device 100 may perform pairing based on the identification information received from the user terminal device 200” in [0064-0065], “the authentication for the wake-up signal succeeds (S440-Y), the analyte monitoring device 100 may operate in the advertising mode (S450). In this case, the analyte monitoring device 100 may perform the communication connection with the user terminal device 200 (S460)” in [0076], and “the authentication of the wake-up signal is successful, the first processor 123 may enter the advertising mode. The first processor 123 may perform the communication connection with the user terminal device 200 through the first communication interface 121”, there is no full recitation of “when the first authentication is successful, establish a communication channel with the user terminal device by: transmitting an advertising message for a pairing process in response to successful completion of the first authentication; performing a second authentication for identification information for pairing received from the user terminal device in response to the advertising message; and establishing the communication channel upon successful completion of the second authentication”. Specifically, there is no recitation of “transmitting an advertising message”, “performing a second authentication”, or “establishing the communication channel upon successful completion of the second authentication”. Claim 9 recites “when the first authentication is successful, establishing a communication channel with the user terminal device by: transmitting an advertising message for a pairing process in response to successful completion of the first authentication; performing a second authentication for identification information for pairing received from the user terminal device in response to the advertising message; and establishing the communication channel upon successful completion of the second authentication” in lines 9-17. However, the Applicant’s Specification does not provide sufficient support for the newly added limitations of “when the first authentication is successful, establish a communication channel with the user terminal device by: transmitting an advertising message for a pairing process in response to successful completion of the first authentication; performing a second authentication for identification information for pairing received from the user terminal device in response to the advertising message; and establishing the communication channel upon successful completion of the second authentication”. Although the Applicant’s Specification recites wherein “the analyte monitoring device 100 may enter the second mode to transmit an advertising packet to a peripheral device. The second mode may be an advertising mode. The advertising mode may refer to a mode in which the analyte monitoring device 100 periodically transmits the advertising signal to the outside for communication connection with the external device such as the user terminal device 200. In the advertising mode, the analyte monitoring device 100 may perform broadcasting to identify the user terminal device 200. The analyte monitoring device 100 may perform pairing based on the identification information received from the user terminal device 200” in [0064-0065], “the authentication for the wake-up signal succeeds (S440-Y), the analyte monitoring device 100 may operate in the advertising mode (S450). In this case, the analyte monitoring device 100 may perform the communication connection with the user terminal device 200 (S460)” in [0076], and “the authentication of the wake-up signal is successful, the first processor 123 may enter the advertising mode. The first processor 123 may perform the communication connection with the user terminal device 200 through the first communication interface 121”, there is no full recitation of “when the first authentication is successful, establish a communication channel with the user terminal device by: transmitting an advertising message for a pairing process in response to successful completion of the first authentication; performing a second authentication for identification information for pairing received from the user terminal device in response to the advertising message; and establishing the communication channel upon successful completion of the second authentication”. Specifically, there is no recitation of “transmitting an advertising message”, “performing a second authentication”, or “establishing the communication channel upon successful completion of the second authentication”. 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 1-16 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 1 recites “when the first authentication is successful, establish a communication channel” in line 12. Claim 1 later recites “establishing the communication channel upon successful completion of the second authentication” in lines 19-20. It is unclear as to when exactly the “communication channel” is established, since it is recited to established both “when the first authentication is successful” and “channel upon successful completion of the second authentication”. Claim 2 recites “first identification information” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “identification information” from Claim 1, or a separate element. Claim 2 recites “second identification information” in line 4. It is unclear as to whether this limitation is referring to the previously introduced “identification information” from Claim 1, or a separate element. Claim 9 recites “when the first authentication is successful, establish a communication channel” in line 9. Claim 9 later recites “establishing the communication channel upon successful completion of the second authentication” in lines 16-17. It is unclear as to when exactly the “communication channel” is established, since it is recited to established both “when the first authentication is successful” and “channel upon successful completion of the second authentication”. Claim 10 recites “first identification information” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “identification information” from Claim 9, or a separate element. Claim 10 recites “second identification information” in line 4. It is unclear as to whether this limitation is referring to the previously introduced “identification information” from Claim 9, or a separate element. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6 is dependent on claim 5 but fails to further limit the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. The Examiner would like to note that claim 14 was also considered under 35 U.S.C. 112(d), and it was determined that unlike claim 6, claim 14 did further limit the subject matter of the claim upon which it depended on. 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. Claims 1-2, 7, 9-10, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Tassel et al (U.S. Publication No. 2020/0375455; cited by Applicant). Regarding Claim 1, Van Tassel discloses an analyte monitoring device (System and method for wireless communication of analyte data; Abstract; [0036]) comprising: an analyte sensor of which at least a portion is configured to be located under a skin of a user and detects an analyte signal related to a glucose concentration (With reference to FIG. 1A, in some embodiments, analyte sensor 10 includes a continuous glucose sensor, for example, a subcutaneous, transdermal (e.g., transcutaneous), or intravascular device; [0162]; Figure 1A); a communication interface including at least one communication circuit (connectivity interface 355; transceiver 360; [0233]; [0238-0239]; Figure 3B); a memory storing at least one instruction (storage 365; [0230-0233]; [0238]; Figure 3B); and at least one processor (processor 380; [0230]; [0239]; Figure 3B), wherein the at least one processor executes the at least one instruction to: periodically activate the communication interface at a predetermined first time interval (As will be further described below, there can be a process for initially establishing communication between display device 310 and the sensor electronics module, e.g., sensor electronics module 12, when the module is first used or re-activated (e.g., the battery is replaced); [0195]; [0325]; Block 1502 includes preconfiguring an analyte sensor system to periodically wake from a low-power passive monitoring mode according to a predetermined interval for waking the analyte sensor system; [0335-0336]); perform a first authentication for a wake-up signal for waking up the analyte monitoring device when the wake-up signal is received from a user terminal device through the activated communication interface (Block 1504 includes receiving a wake signal from a display device before expiration of the predetermined interval while in the low-power passive monitoring mode, thereby causing the analyte sensor system to wake before expiration of the predetermined interval. For example, analyte sensor system 1408 can receive wake signal 1412 from display device 1410 before expiration of the predetermined interval while in the low-power passive monitoring mode, thereby causing analyte sensor system 1408 to wake before expiration of the predetermined interval; [0336]); when the first authentication is successful, establish a communication channel the user terminal by: transmitting an advertising message for a pairing process in response to successful completion of the first authentication (Block 1506 includes transmitting an advertisement message in response to the wake signal. For example, analyte sensor system 1408 can be configured to exit the low-power passive monitoring mode and transmit advertisement message 1414 in response to receiving wake signal 1408; [0337]; 1506 in Figure 15A; [0337]); performing a second authentication for identification information for pairing received from the user terminal device in response to the advertising message (Block 1508 includes receiving a pairing request from the display device. For example, analyte sensor system 1408 can be configured to receive pairing request 1416 from display device 1410; [0338]); and establishing the communication channel upon successful completion of the second authentication (Block 1510 includes transmitting a pairing request acceptance message to the display device. For example, analyte sensor system 1408 can be configured to transmit pairing request acceptance message 1418 to display device 1410; [0339]); and transmit information related to the analyte signal to the user terminal device at a predetermined second time interval through the communication channel (Block 1512 includes transmitting sensor data to the display device. For example, analyte sensor system 1408 can be configured to enter a secure sensor communication session based on the above communications in which analyte sensor system 1408 can transmit data, e.g., sensor data, to display device 1410. In some embodiments, transmission of such sensor data can comprise fulfilling a backfill request for specific data from display device 1410 and/or any other data at a time before a predetermined interval for waking analyte sensor system 1408 has expired; [0340]). Regarding Claim 2, Van Tassel discloses wherein the wake-up signal includes first identification information for establishing the communication channel, and wherein the performing of the second authentication comprises determining whether the first identification information matches second identification information pre-stored in the memory (The method includes receiving a transmitter ID corresponding to the analyte sensor system. The method includes comparing the received transmitter ID to a range of transmitter IDs corresponding to currently deployed analyte sensor systems. The method includes establishing a wireless connection with the analyte sensor system based on a determination that the received transmitter ID is within the range of transmitter IDs corresponding to analyte sensor systems currently deployed; [0047]; Block 1906 includes verifying the encrypted second security code. For example, display device 1810 can be configured to verify that the second security code corresponds to a predetermined, previously known or otherwise determinable security code and/or that the second security code was encrypted utilizing the first security code corresponding to and/or associated with display device 1810; [0362]). Regarding Claim 7, Van Tassel discloses wherein the at least one processor is further configured to variably set at least one of the first time interval or the second time interval based on a remaining amount of a battery included in the analyte monitoring device (analyte sensor system 308 can be configured to automatically revert to the sleep mode after the sensor calibration data is stored in the one or more locations within storage 365. Reversion to sleep mode upon storage of the sensor calibration data can minimize or at least substantially reduce power usage of analyte sensor system 308 during and after the factory calibration process, thereby extending useful battery life during subsequent use by a patient; [0232]; the design enables system startup, inter-chip communication, application task scheduling, maximization of battery life in storage as well as active modes, and utilization of control points and indications by API 450 associated with radio 425…it is contemplated that, in the storage mode, radio 425 can be configured to be in a deep sleep mode. This can advantageously extend/maximize the battery life of analyte sensor system 408. In some embodiments, upon interacting with display device 310, for example via NFC or visible light modulating and emitting protocols, analyte sensor system 408 can exit the storage mode. In some embodiments, upon detecting that sensor 405 has been inserted into the host, analyte sensor system 408 can automatically exit storage mode and enter an active mode; [0252-0255]; In active mode, a low power mode (LPM) can still be used (e.g., to extend/maximize battery life), but RTC 350 but RTC 350 can be activated/enabled. This can allow processor 420 to track time accurately and perform other clock-based functions while still allowing for power savings; [0259]; Because it is desirable to preserve battery life of analyte sensor system 308, analyte sensor system 308 can be configured to initially pair and connect with a display device, transfer data to the display device, disconnect from the display device to enter a low-power and/or sleep mode to preserve battery, and then periodically reconnect to the display device based on a predetermined connection interval (e.g., every 5 minutes); [0395]). Regarding Claim 9, Van Tassel discloses a controlling method of an analyte monitoring device (System and method for wireless communication of analyte data; Abstract; [0036]) including an analyte sensor of which at least a portion is configured to be located under a skin of a user and detects an analyte signal related to a glucose concentration (With reference to FIG. 1A, in some embodiments, analyte sensor 10 includes a continuous glucose sensor, for example, a subcutaneous, transdermal (e.g., transcutaneous), or intravascular device; [0162]; Figure 1A), the controlling method comprising: periodically activating a communication interface (connectivity interface 355; transceiver 360; [0233]; [0238-0239]; Figure 3B) included in the analyte monitoring device at a predetermined first time interval (As will be further described below, there can be a process for initially establishing communication between display device 310 and the sensor electronics module, e.g., sensor electronics module 12, when the module is first used or re-activated (e.g., the battery is replaced); [0195]; Block 1502 includes preconfiguring an analyte sensor system to periodically wake from a low-power passive monitoring mode according to a predetermined interval for waking the analyte sensor system; [0335]); performing a first authentication for a wake-up signal for waking up the analyte monitoring device when the wake-up signal is received from a user terminal device through the activated communication interface (Block 1504 includes receiving a wake signal from a display device before expiration of the predetermined interval while in the low-power passive monitoring mode, thereby causing the analyte sensor system to wake before expiration of the predetermined interval. For example, analyte sensor system 1408 can receive wake signal 1412 from display device 1410 before expiration of the predetermined interval while in the low-power passive monitoring mode, thereby causing analyte sensor system 1408 to wake before expiration of the predetermined interval; [0336]); when the first authentication is successful, establishing a communication channel with the user terminal device by: transmitting an advertising message for a pairing process in response to successful completion of the first authentication (Block 1506 includes transmitting an advertisement message in response to the wake signal. For example, analyte sensor system 1408 can be configured to exit the low-power passive monitoring mode and transmit advertisement message 1414 in response to receiving wake signal 1408; [0337]; 1506 in Figure 15A; [0337]); performing a second authentication for identification information for pairing received from the user terminal device in response to the advertising message (Block 1508 includes receiving a pairing request from the display device. For example, analyte sensor system 1408 can be configured to receive pairing request 1416 from display device 1410; [0338]); and establishing the communication channel upon successful completion of the second authentication (Block 1510 includes transmitting a pairing request acceptance message to the display device. For example, analyte sensor system 1408 can be configured to transmit pairing request acceptance message 1418 to display device 1410; [0339]); and transmit information related to the analyte signal to the user terminal device at a predetermined second time interval through the communication channel (Block 1512 includes transmitting sensor data to the display device. For example, analyte sensor system 1408 can be configured to enter a secure sensor communication session based on the above communications in which analyte sensor system 1408 can transmit data, e.g., sensor data, to display device 1410. In some embodiments, transmission of such sensor data can comprise fulfilling a backfill request for specific data from display device 1410 and/or any other data at a time before a predetermined interval for waking analyte sensor system 1408 has expired; [0340]). Regarding Claim 10, Van Tassel discloses wherein the wake-up signal includes first identification information for establishing the communication channel, and wherein the performing of the second authentication comprises determining whether the first identification information matches second identification information pre-stored in the memory (The method includes receiving a transmitter ID corresponding to the analyte sensor system. The method includes comparing the received transmitter ID to a range of transmitter IDs corresponding to currently deployed analyte sensor systems. The method includes establishing a wireless connection with the analyte sensor system based on a determination that the received transmitter ID is within the range of transmitter IDs corresponding to analyte sensor systems currently deployed; [0047]; Block 1906 includes verifying the encrypted second security code. For example, display device 1810 can be configured to verify that the second security code corresponds to a predetermined, previously known or otherwise determinable security code and/or that the second security code was encrypted utilizing the first security code corresponding to and/or associated with display device 1810; [0362]). Regarding Claim 15, Van Tassel discloses wherein at least one of the first time interval or the second time interval is variably set based on a remaining amount of a battery included in the analyte monitoring device (analyte sensor system 308 can be configured to automatically revert to the sleep mode after the sensor calibration data is stored in the one or more locations within storage 365. Reversion to sleep mode upon storage of the sensor calibration data can minimize or at least substantially reduce power usage of analyte sensor system 308 during and after the factory calibration process, thereby extending useful battery life during subsequent use by a patient; [0232]; the design enables system startup, inter-chip communication, application task scheduling, maximization of battery life in storage as well as active modes, and utilization of control points and indications by API 450 associated with radio 425…it is contemplated that, in the storage mode, radio 425 can be configured to be in a deep sleep mode. This can advantageously extend/maximize the battery life of analyte sensor system 408. In some embodiments, upon interacting with display device 310, for example via NFC or visible light modulating and emitting protocols, analyte sensor system 408 can exit the storage mode. In some embodiments, upon detecting that sensor 405 has been inserted into the host, analyte sensor system 408 can automatically exit storage mode and enter an active mode; [0252-0255]; In active mode, a low power mode (LPM) can still be used (e.g., to extend/maximize battery life), but RTC 350 but RTC 350 can be activated/enabled. This can allow processor 420 to track time accurately and perform other clock-based functions while still allowing for power savings; [0259]; Because it is desirable to preserve battery life of analyte sensor system 308, analyte sensor system 308 can be configured to initially pair and connect with a display device, transfer data to the display device, disconnect from the display device to enter a low-power and/or sleep mode to preserve battery, and then periodically reconnect to the display device based on a predetermined connection interval (e.g., every 5 minutes); [0395]). 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 11 are rejected under 35 U.S.C. 103 as being unpatentable over Van Tassel et al in view of Sahin et al (U.S. Publication No. 2022/0095228; cited by Applicant). Regarding Claim 3, Van Tassel fails to teach wherein the at least one processor demodulates a wake-up portion of the first signal to acquire a first value, the first portion modulated based on on-off keying (OOK), and determines that the first authentication is successful when the first value matches a second value pre-stored in the memory. In a similar technical field, Sahin teaches systems, methods, and instrumentalities associated with wake-up signals (Abstract), wherein the at least one processor demodulates a first portion of the wake-up signal to acquire a first value (The transceiver 120 may be configured to modulate the signals that are to be transmitted by the transmit/receive element 122 and to demodulate the signals that are received by the transmit/receive element 122; [0045]), the first portion modulated based on on-off keying (OOK), and determines that the first authentication is successful when the first value matches a second value pre-stored in the memory (A sequence of OOK symbols or a set of OOK symbols (e.g., coded or not coded) may be used for a SYNC (e.g., a SYNC field). If a set of possible OOK sequences is used for SYNC (e.g., SYNC sequences), an (e.g., each) OOK sequence may be associated with a cell ID, a WTRU group ID, or a WTRU ID, which in examples, may enable cell-wise wake-up, group wake-up, or individual wake-up, respectively; [0117-0122]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the OOK teachings of Sahin into those of Van Tassel for its easy implementation, simple receiver design, and high power efficiency. Regarding Claim 11, Van Tassel fails to teach wherein the performing of the first authentication includes: demodulating a wake-up portion of the first signal to acquire a first value, the first portion modulated based on on-off keying (OOK); and determining that the first authentication is successful when the first value matches a second value pre-stored in the memory. In a similar technical field, Sahin teaches systems, methods, and instrumentalities associated with wake-up signals (Abstract), wherein the performing of the first authentication includes: demodulating a first portion of the wake-up signal to acquire a first value (The transceiver 120 may be configured to modulate the signals that are to be transmitted by the transmit/receive element 122 and to demodulate the signals that are received by the transmit/receive element 122; [0045]), the first portion modulated based on on-off keying (OOK); and determining that the authentication is successful when the first value matches a second value pre-stored in the memory (A sequence of OOK symbols or a set of OOK symbols (e.g., coded or not coded) may be used for a SYNC (e.g., a SYNC field). If a set of possible OOK sequences is used for SYNC (e.g., SYNC sequences), an (e.g., each) OOK sequence may be associated with a cell ID, a WTRU group ID, or a WTRU ID, which in examples, may enable cell-wise wake-up, group wake-up, or individual wake-up, respectively; [0117-0122]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the OOK teachings of Sahin into those of Van Tassel for its easy implementation, simple receiver design, and high power efficiency. Claims 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Van Tassel et al in view of Dexcom (U.S. Patent No. 11,471,052; cited by Applicant). Regarding Claim 4, Van Tassel fails to teach wherein the at least one processor does not perform signal processing on the analyte signal while periodically activating the communication interface at the predetermined first time interval, and the signal processing includes at least one of an analog-to-digital conversion, a noise filtering, or a calibration. In a similar technical field, Dexcom teaches systems, methods, apparatuses, and devices, for the wireless communication of analyte data (Abstract), wherein the at least one processor does not perform signal processing on the analyte signal while periodically activating the communication interface at the predetermined first time interval, and the signal processing includes at least one of an analog-to-digital conversion, a noise filtering, or a calibration (Raw sensor data 430 can include hardware that transfers sensor data gathered by sensor 405 from AFE 410 to processor 420. Such data can be referred to herein as raw sensor data or raw analyte data. Configuration 440 can be a two-way interface between processor 420 and AFE 410. In some cases, configuration 440 can be implemented using I2C, but SPI or another interface configuration can also be used. Processor 420 and radio 425 can likewise use a SPI and/or I2C bus for communication and data transfer. In some cases, additional hardware and software can be used to create an asynchronous interface between processor 420 and radio 425 when using synchronous protocols (e.g., SPI and the like); Column 50 Lines 50-60; Block 2806 includes delaying conversion of the raw data to estimated analyte values until at least after the sensor session has concluded. For example, analyte sensor system 308 can be configured to not convert or otherwise process the raw data stored in storage 365 during the sensor session. In some embodiments, analyte sensor system 308 can be configured to convert and/or process the raw data after the sensor session has concluded. Alternatively or additionally, analyte sensor system 308 can be configured to transmit the raw data and/or a processed version of the raw data, processed by analyte sensor system 308 after conclusion of the sensor session, to another device, e.g., HCP device 150 (FIG. 26), server system 334 (FIG. 3A), or any other display device described herein, during or after the sensor session, for processing, analyzing and/or displaying after the sensor session has concluded; Column 90 Line 58 – Column 91 Line 6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the raw data teachings of Dexcom into those of Van Tassel in order to reduce the computational and operational burden on the analyte sensor system (Dexcom Column 90 Lines 28-31). Regarding Claim 12, Van Tassel fails to teach wherein signal processing is not performed on the analyte signal while periodically activating the communication interface at the predetermined first time interval, and the signal processing on the analyte signal includes at least one of an analog-to-digital conversion, a noise filtering, or a calibration. In a similar technical field, Dexcom teaches systems, methods, apparatuses, and devices, for the wireless communication of analyte data (Abstract), wherein signal processing is not performed on the analyte signal while periodically activating the communication interface at the predetermined first time interval, and the signal processing on the analyte signal includes at least one of an analog-to-digital conversion, a noise filtering, or a calibration (Raw sensor data 430 can include hardware that transfers sensor data gathered by sensor 405 from AFE 410 to processor 420. Such data can be referred to herein as raw sensor data or raw analyte data. Configuration 440 can be a two-way interface between processor 420 and AFE 410. In some cases, configuration 440 can be implemented using I2C, but SPI or another interface configuration can also be used. Processor 420 and radio 425 can likewise use a SPI and/or I2C bus for communication and data transfer. In some cases, additional hardware and software can be used to create an asynchronous interface between processor 420 and radio 425 when using synchronous protocols (e.g., SPI and the like); Column 50 Lines 50-60; Block 2806 includes delaying conversion of the raw data to estimated analyte values until at least after the sensor session has concluded. For example, analyte sensor system 308 can be configured to not convert or otherwise process the raw data stored in storage 365 during the sensor session. In some embodiments, analyte sensor system 308 can be configured to convert and/or process the raw data after the sensor session has concluded. Alternatively or additionally, analyte sensor system 308 can be configured to transmit the raw data and/or a processed version of the raw data, processed by analyte sensor system 308 after conclusion of the sensor session, to another device, e.g., HCP device 150 (FIG. 26), server system 334 (FIG. 3A), or any other display device described herein, during or after the sensor session, for processing, analyzing and/or displaying after the sensor session has concluded; Column 90 Line 58 – Column 91 Line 6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the raw data teachings of Dexcom into those of Van Tassel in order to reduce the computational and operational burden on the analyte sensor system (Dexcom Column 90 Lines 28-31). Claims 5-6 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Van Tassel et al in view of Paul et al (U.S. Publication No. 2021/0350918; cited by Applicant). Regarding Claim 5, Van Tassel fails to teach wherein, when a strength of the wake-up signal is less than a preset value, the at least one processor does not perform the first authentication for the wake-up signal, or determines that the first authentication for the wake-up signal fails. In a similar technical field, Paul teaches a secure health management system (Abstract), wherein, when a strength of the wake-up signal is less than a preset value, the at least one processor does not perform the first authentication for the wake-up signal, or determines that the first authentication for the wake-up signal fails (one of a number of proximity-based identification protocols may be used by SS 8 and display device 150. A proximity-based identification protocol helps ensure that only two devices in close proximity to each other are able to communicate and complete the identification process. For example, in certain embodiments, a proximity-based identification protocol may involve configuring a device (e.g., display device 150 and/or SS 8) to only communicate (e.g., for the purpose of identification, authentication, bonding, and/or pairing) with another device with a received signal strength indicator (RSSI) of more than a certain threshold, meaning the device (e.g., display device 150) receives signals (e.g., advertising the SIN), from the other device (e.g., SS 8), that have a signal strength, as measured by the device, that satisfy the threshold. Utilizing RSSI in a proximity-based identification protocol helps ensure that, for example, during the identification phase, display device 150 only identifies SS 8 if SS 8 has an RSSI that is higher than a minimum threshold. Therefore, any SSs with RSSIs lower than the threshold would not be included in display device 150's search. Note that it is likely that a malicious device attempting to impersonate SS 8 will not be very close to the user or at least as close to display device 150 as SS 8. As such, a malicious device with an RSSI lower than the threshold would be excluded from display device 150's search; [0111]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the signal strength teachings of Paul into those of Van Tassel in order to prevent a malicious device from attempting to impersonate the analyte sensor system (Paul [0111]). Regarding Claim 6, Van Tassel fails to teach wherein the at least one processor does not perform the first authentication when the strength of the wake-up signal is less than the preset value. In a similar technical field, Paul teaches a secure health management system (Abstract), wherein the at least one processor does not perform the first authentication when the strength of the wake-up signal is less than the preset value (one of a number of proximity-based identification protocols may be used by SS 8 and display device 150. A proximity-based identification protocol helps ensure that only two devices in close proximity to each other are able to communicate and complete the identification process. For example, in certain embodiments, a proximity-based identification protocol may involve configuring a device (e.g., display device 150 and/or SS 8) to only communicate (e.g., for the purpose of identification, authentication, bonding, and/or pairing) with another device with a received signal strength indicator (RSSI) of more than a certain threshold, meaning the device (e.g., display device 150) receives signals (e.g., advertising the SIN), from the other device (e.g., SS 8), that have a signal strength, as measured by the device, that satisfy the threshold. Utilizing RSSI in a proximity-based identification protocol helps ensure that, for example, during the identification phase, display device 150 only identifies SS 8 if SS 8 has an RSSI that is higher than a minimum threshold. Therefore, any SSs with RSSIs lower than the threshold would not be included in display device 150's search. Note that it is likely that a malicious device attempting to impersonate SS 8 will not be very close to the user or at least as close to display device 150 as SS 8. As such, a malicious device with an RSSI lower than the threshold would be excluded from display device 150's search; [0111]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the signal strength teachings of Paul into those of Van Tassel in order to prevent a malicious device from attempting to impersonate the analyte sensor system (Paul [0111]). Regarding Claim 13, Van Tassel fails to teach wherein, when a strength of the wake-up signal is less than a preset value, not performing the first authentication for the wake-up signal, or determining that the first authentication for the wake-up signal fails. In a similar technical field, Paul teaches a secure health management system (Abstract), wherein, when a strength of the wake-up signal is less than a preset value, not performing the first authentication for the wake-up signal, or determining that the first authentication for the wake-up signal fails (one of a number of proximity-based identification protocols may be used by SS 8 and display device 150. A proximity-based identification protocol helps ensure that only two devices in close proximity to each other are able to communicate and complete the identification process. For example, in certain embodiments, a proximity-based identification protocol may involve configuring a device (e.g., display device 150 and/or SS 8) to only communicate (e.g., for the purpose of identification, authentication, bonding, and/or pairing) with another device with a received signal strength indicator (RSSI) of more than a certain threshold, meaning the device (e.g., display device 150) receives signals (e.g., advertising the SIN), from the other device (e.g., SS 8), that have a signal strength, as measured by the device, that satisfy the threshold. Utilizing RSSI in a proximity-based identification protocol helps ensure that, for example, during the identification phase, display device 150 only identifies SS 8 if SS 8 has an RSSI that is higher than a minimum threshold. Therefore, any SSs with RSSIs lower than the threshold would not be included in display device 150's search. Note that it is likely that a malicious device attempting to impersonate SS 8 will not be very close to the user or at least as close to display device 150 as SS 8. As such, a malicious device with an RSSI lower than the threshold would be excluded from display device 150's search; [0111]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the signal strength teachings of Paul into those of Van Tassel in order to prevent a malicious device from attempting to impersonate the analyte sensor system (Paul [0111]). Regarding Claim 14, Van Tassel fails to teach wherein, when the strength of the wake-up signal is less than the preset value, the first authentication is not performed. In a similar technical field, Paul teaches a secure health management system (Abstract), wherein, when the strength of the wake-up signal is less than the preset value, the first authentication is not performed (one of a number of proximity-based identification protocols may be used by SS 8 and display device 150. A proximity-based identification protocol helps ensure that only two devices in close proximity to each other are able to communicate and complete the identification process. For example, in certain embodiments, a proximity-based identification protocol may involve configuring a device (e.g., display device 150 and/or SS 8) to only communicate (e.g., for the purpose of identification, authentication, bonding, and/or pairing) with another device with a received signal strength indicator (RSSI) of more than a certain threshold, meaning the device (e.g., display device 150) receives signals (e.g., advertising the SIN), from the other device (e.g., SS 8), that have a signal strength, as measured by the device, that satisfy the threshold. Utilizing RSSI in a proximity-based identification protocol helps ensure that, for example, during the identification phase, display device 150 only identifies SS 8 if SS 8 has an RSSI that is higher than a minimum threshold. Therefore, any SSs with RSSIs lower than the threshold would not be included in display device 150's search. Note that it is likely that a malicious device attempting to impersonate SS 8 will not be very close to the user or at least as close to display device 150 as SS 8. As such, a malicious device with an RSSI lower than the threshold would be excluded from display device 150's search; [0111]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the signal strength teachings of Paul into those of Van Tassel in order to prevent a malicious device from attempting to impersonate the analyte sensor system (Paul [0111]). Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CHANEL J YOON/Examiner, Art Unit 3791
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Prosecution Timeline

May 24, 2024
Application Filed
Mar 23, 2026
Non-Final Rejection mailed — §102, §103, §112
Jun 22, 2026
Response Filed
Sep 04, 2026
Final Rejection mailed — §102, §103, §112 (current)

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