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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/16/2025 has been entered.
Status of the Claims
The status of the claims as of the response filed 10/16/2025 is as follows:
Claims 18, 20, and 26-32 are pending.
Claims 1-17 and 19, 21-25 are canceled.
Claims 26-32 are new.
Claims 18, and 27 were amended.
All claims have been considered below.
Response to amendment
Applicant Claims 18, 20, and 26-34 in the context of 35 USC 101 upon reconsideration was found eligible.
Response to Arguments
Response to Arguments 35 U.S.C. § 102 and 103 Applicant’s arguments, see page 8, filed 10/16/2025, with respect to amended Claims 18 and 27. Claims 28-34 are new. Claims 20 and 26 were previously presented. All pending claims 18, 20, and 26-34 have been fully considered and the arguments are not persuasive.
Applicant Arguments Regarding Canceled Claims
Applicant states that "Claims 1-15, 19 and 21-25 have been canceled" and submits that "the rejections to those claims are now moot."
Examiner acknowledges the cancellation of claims 1-15, 19, and 21-25. Consequently, the rejections under 35 U.S.C. 102 and 103 directed to these specific claims in the prior Office Action had been withdrawn for compact prosecution.
Applicant Arguments Regarding Pending Claims (18, 20, 26-34)
Applicant argues that "the references relied upon in the Office Action... fail to disclose all of the limitations of claim 18 as amended" and requests that "the rejections to claim 18, and all claims dependent therefrom, be withdrawn." In essence, Applicant makes a general assertion that the amendments to claim 18 overcome the prior art, and therefore all dependent claims are allowable.
Examiner respectfully disagrees that amended claim 18 and its dependent claims (20, 26-34) are allowable. Applicant's argument is a conclusory statement, as it fails to identify which specific limitations of the amended claims are allegedly missing from the prior art, and provides no evidence or reasoning to support this assertion. While the prior rejections of claims 18 and 26-27 over Fischer, Devdas, etc., were withdraw, the pending claims are rejected on new grounds. As detailed in the "New U.S.C 35 102 and 103," amended claim 18, new claim 33 (as a subset of 18), and dependent claims 20, 26-29, and 34 are rejected as anticipated by Halac. Furthermore, new claims 30-32 are rejected under 35 U.S.C 103 over Halac in view of Al-Ali. These new rejections fully map all limitations of the pending claims to the cited references. Refer to rejection 35 U.S.C 102 and 103 below for further details
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 18, 20, 26-29 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Halac, US11350857 in view of US 10841286 B1-Davidovics.
Halac teaches Claim 18:
A method of operation of a medical monitoring system, the method comprising: (Halac, Col. 2, ll. 20-35)
applying a sensor control device to a first user with an applicator, wherein application to the user automatically and non-manually activates the sensor control device by propagation of an electrical interrupt signal to an integrated circuit of the sensor control device, and wherein the sensor control device comprises a cellular radio module and a lactate sensor configured to measure levels of lactate within a bodily fluid of the first user when in contact with the bodily fluid of the user;
Halac in figure 1, 2, 5 and Col. 27, ll. 5—67, Col. 14, ll. 55-67, Col. 16, ll. 1-20, Col. 2, ll. 1-20 an electronic circuitry for processing and communicating glucose related information, describe a sensor in communication wireless WIFI and/or cellular or other wireless connectivity. In Col 4, ll. 4-46, Col. 14, 50-67, Col. 17, ll. 1-25 describe an activation detection by a signal generated, in Col 4, ll. 4-46, col. 2, ll. 45 – 67 describe detecting activation events as primary and secondary signals. In col. 4, ll. 1-25, described that primary signal could be voltage, current, count, or other signal, using in combination with analyte sensor signal. These signals could for example trigger an indication to exit to lower power state and transition into the operational state Col. 4, ll. 35-67, Col. 5, ll. 25-67, Col. 15, ll. 1-25. Halac in Col. 19, ll. 50-67 explain that analyte include biological fluid and also include lactate in Col. 20, ll. 28-35
connecting the cellular radio module of the sensor control device to one or more cellular networks; (figure 1, 2 and Col. 14, ll. 55-67, Col. 16, ll. 1-20, Col. 2, ll. 1-20)
transmitting, with the cellular radio module, first medical data indicative of levels of lactate to a medical data server of the medical monitoring system via the one or more cellular networks; (Halac, Col. 1, ll. 40-67, Col. 20, ll. 1-45, Col. 16, ll. 1-35, Col. 27, ll. 49-67, Col. 17, ll. 20-35)
Halac describes a system 100 (a medical monitoring system) that includes an analyte sensor system 8 and a server system 134 (a medical data server) configured to collect analyte data. The sensor system includes a telemetry module or transceiver 510 (a cellular radio module) for transmitting data (analyte data). Halac specifies this transmission occurs over communication media 305, which is explicitly defined as potentially using a cellular communication protocol (e.g., 4G LTE/5G and the like) (via the one or more cellular networks). Furthermore, Halac explicitly defines analytes to include... lactate, meaning the analyte data being transmitted is indicative of levels of lactate.
receiving, by the medical data server a receiving device, a ; (Halac Col. 16, ll. 1-35, Col.17, ll. 1-15, Col. 18, ll. 30-67, Col. 19, ll. 1-20, Col. 49, ll. 1-35, Col. 12, ll. 1-35, Col. 15, 30-67)
Under broadest reasonable interpretation the limitation describe a medical data server receiving any communication intended to enable or authorize operation of a data-receiving device, provided the communication includes information associating the activation with a particular user.
Halac describes including for authentication of partner devices for the purpose to exchange of analyte data, medicament data, other data, and/or control signaling. The partner devices could be for example a smart fridge or mirror, key fob, and other devices. Halac also describe the server 334a the use of communication media to the delivery of analyte data and messaging related to for example authentication and explain that it is between a display devices and/or partner devices. Therefore, Halac describe an authentication process that identify the receiver devices (partner or display devices) by the server 334a.
; (Halac Col. 16, ll. 1-35, Col. 18, ll. 30-67, Col. 19, ll. 1-20, Col. 49, ll. 1-35, Col. 12, ll. 1-35, Col. 15, 30-67)
Halac describes a system where the server system 334 (the medical data server) sends communications, such as an indication, to display device 310 (a computing device associated with the first user). The purpose of communications within this system is to securely manage data, which includes authentication and pairing user accounts (a request to authenticate).
(Halac, Col. 16, lines 22-26; Col. 18, lines 30-67; Col. 17, line 30-67)
Halac describes that the server 334a (the medical data server) may receive... information... from... display devices 310 (the computing device associated with the first user). This received information is part of a larger communication process that includes authentication and pairing user accounts to one or more analyte sensor systems.
providing, by the medical data server to the data receiving device, the first medical data associated with the first user; Col. 18, lines 1-67, Col. 16, ll. 14-39)
Halac describes the server system 334 (the medical data server) providing communications from server system 334 to display device 310 (the data receiving device). This communication includes an indication, notification, alert, or warning (the first medical data) which is user-specific, as it is based on... diagnostic feedback for the sensor pair[ed] to that specific user account (associated with the first user).
monitoring, by the medical data server, a status of the one or more cellular networks; (Halac, Col. 18, ll. 1-67, Col. 17, ll. 15-45)
Halac describe a server that has cellular communication protocol and monitoring information and processing messages related to frequency bands and timing of transmission
and sending a notification to at least one of the sensor control device, the computing device, and the data receiving device, wherein the notification is of a (Halac, Col. 18, ll. 1-67, Col. 17, ll. 15-45, Col. 55, ll. 1- 25)
Halac explicitly states the server sends notifications. Halac teaches that server 334a may process and exchange messages... related to... alarms, alerts, notifications, and so on. In addition, the actual content of the notification is non-functional descriptive language, because it does not relate to any other positively recited steps of the invention.
Halac as explained above teaches all limitations, and Halac has a server that it is communicate analyte data and messaging related for example authentication between partner and display devices. However it is not explicitly said that the partner device develop a request to being activate.
except the following: receiving, by the medical data server a receiving device, a
However Davidovics describe “… the person operating the mobile device of the patient and doctor, to make sure that it is actually the authorizing person or authorized HCPs requesting or authorizing access to the PHR data from the PHV server, using authenticated patient's or doctor's mobile device or computer.“ Col. 8 ll. 50-67 – Col. 9, 1 - 20 a PHV server receiving authorization process, and requesting or authorizing access to the PHR data for the authenticated patient’s or doctor’s mobile devices. Also here “for access to PMR data is the novel use of the existing and well known WIFI networks. As part of the configuration process, the doctor may use the hardware and software app on his mobile device to generate and send his digital fingerprint to the server, which is used later for confirmation that the same doctor is using the mobile device for access to patient's PHR. “ Col. 21, ll. 30-47, “ At Step 1, the patient or the application software on the patient mobile device 1210 informs the doctor or communicates to the doctor's mobile device 1220 with instructions to go to the SMR server, through the Internet, and request patient's access to that patient's PHR stored in the encrypted format in the SMR PHV 1280.”, “request access from the SMR Server 1250”, Col. 25, ll. 35-47, clearly explain that a doctor to access to PMR data uses his mobile to sends his digital finger print to the server it is clear that the process it is for activate the doctor device to being able to receive/view patient data.
Davidovics describe in Col. 29 ll. 55- Col. 30, ll. 1-30, explain that the doctor give token to the patient to grant access to patient data where it is received by the server see also figure 12.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to combine Halac with Davidovics, because Halac mention authentication process for pairing devices and communicate wirelessly “communicate (e.g., wirelessly) with analyte sensor system 8, including for authentication of partner device(s) 136 and/or analyte sensor system 8” in Col. 16, ll. 14-39, a PHOSITA looking for the how implement the authentication process not explicitly describe in Halac, could found Davidovics that describe the Server authentication devices process for the purpose of view/update patient data (Davidovics, abstract). A PHOSITA using the medical server in Halac would like to combine with the method of Davidovic, for the purpose to maintaining a secure and efficient distributed Internet medical patient data, Davidovics, Col. 1, ll. 20-40.
Halac in combination with Davidovics teaches Claim 20:
Halac teaches The method of claim 18, further comprising:
prior to providing the medical data associated with the first user to the data receiving device, sending, by the medical data server, an activation confirmation notification to the user device or the data receiving device. (Halac, Col. 18, ll. 1-67, Davidovics Col. 29 ll. 55- Col. 30, ll. 1-30, fig. 12)
Halac's Server 334a (the "medical data server") is explicitly taught to send various messages, including "notifications" and "authentication" messages. Under BRI, an "authentication" message is a type of "activation confirmation notification" because it confirms the device is authorized (i.e., "activated") to receive data. Also as explained above in obvious rational claim 18, Davidovics has the token communication describe prior to allow the doctor to access patient data.
Halac in combination with Davidovics teaches Claim 26.
The method of claim 18, wherein the request to activate the data receiving device comprises a first location of the data receiving device and the request to authenticate the data receiving device comprises a second location of the data receiving device. (Halac, Col. 6, ll. 1-35, Col. 51, ll. 25-67, Col. 55, ll. 5-40, Col. 54, ll. 19-55, Col. 16, ll. 1-35)
Halac describes using location and proximity data to trigger a transition from a low-power (storage) mode to an active (operational) mode. This transition is a "request to activate" that "comprises a location."
However does not describe explicitly that such process it is for authentication process. But a PHOSITA could noticed that Halac describe the using of location and proximity data and also authentication process (Halac, Col. 16, ll. 14-39). A PHOSITA looking for expand capability of proximity data could found Davidovics location authentication process describe in Col. 7, ll. 30-40, Col. 15, ll. 10-43, fig.16 transmitting and evaluating proximity information from a patient's mobile device at a Proximity Detection Server, while an HCP Mobile Device Server receives and processes the healthcare professional's device information, ultimately allowing the patient to grant secure data access based on physical presence and key authorization using physical location and the location data from the patient’s devices to confirm required proximity.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to combine Halac with Davidovics to use location authentication process to allow the system protects patients data in even if someone illegally obtains the private key of a particular patient. Thus, in order to actually gain access to the patient’s data, the system could require both the private key of the PHR data owner and the authorized mapping or location ids of the stored patient's records in the PHV. Davidovics, Col. 8, ll. 50-67
Halac in combination with Davidovics teaches Claim 27.
The method of claim 26, further comprising: prior to providing the first medical data associated with the first user to the data receiving device, determining whether to authenticate the data receiving device based on a comparison of the first location and the second location. (Davidovics location authentication process describe in Col. 7, ll. 30-40, Col. 15, ll. 10-43, fig.16)
Halac teaches Claim 28.
The method of claim 18, wherein the notification is sent to the sensor control device, the method further comprising outputting, by the sensor control device, the notification to the first user. (Halac, Col. 18, ll. 1-67)
Halac discloses that a user receives an indication, notification, alert, or warning … on display device 310 and/or through analyte sensor system 308, from server system 334.
Halac teaches claim 29.
The method of claim 28, wherein the notification is output to the first user by the sensor control device by at least one of a display, a light, a speaker, haptic feedback, and/or a shock. (Halac, Col. 18, ll. 1-67)
Halac teaches that notifications are provided “through analyte sensor system 308,” i.e., the wearable itself presents the alert to the user, and that the server processes and exchanges … alerts, notifications” among components including the analyte sensor system on a display.
Halac teaches Claim 34.
The method of claim 33, wherein the medical monitoring system operates in a hybrid blinded mode with respect to the first user. (Halac, Col. 73, ll. 1-67, Col. 74, ll. 20-67,
Halac shows that its “state machine 1430” can “disable all states except pre-count sampling” and that “threshold detection module 1422… generates a wakeup signal” when certain sensor values are reached. In plain terms, this means the system can stop normal data processing (blinded) but still wake and alert when needed (hybrid). Under MPEP §2111’s broadest reasonable interpretation rule, this operational mode in Halac clearly meets “a hybrid blinded mode” because it performs limited sensing silently while selectively alerting the user
Note: Claim 33 is rejected with Claim 18 for being very similar.
Claim(s) 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halac, US11350857 in view of US20180225960- Al - Ali
Halac teaches Claim 30.
The method of claim 18, wherein the notification of a predicted disconnection is a (Halac, Col. 54, ll. 20-50, Col. 18, ll. 1-67)
Halac teaches user-directed alerts in a cellular network system where signal-strength measurements (RSSI) are monitored and used to trigger device behavior, and where the server handles “alerts, notifications” across those communication links.
However, Halac fails to disclose that the notification is a predictive low network alert. Halac’s alerts are general system notifications, not alerts specifically generated to predict a network failure based on monitored network quality.
Al-Ali teaches the missing element, describing a system that monitors the health of a physiological monitoring system (Al-Ali, Abstract) by monitoring parameters such as network traffic congestion levels (Al-Ali, para. [0007]) and reducing a data transfer rate (Al-Ali, para. [0006]). Al-Ali further teaches generating a notification (Al-Ali, para. [0008]) to predict issues that will occur (Al-Ali, para. [0007]). A notification generated in response to network traffic congestion or a reducing a data transfer rate is a low network alert.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Halac with Al-Ali. Halac's system is a medical system (Halac, Col. 1, ll. 18-24) “transmission to wireless display devices” (Halac, Col. 1, ll. 55-67). A skill in the art in view that Halac describe cellular communication of patient data and RSSI being monitored would recognize that an unexpected loss of this network communication (Al-Ali, para. 0006) is a critical failure point that compromises the system's core function and patient safety. This would motivate the POSITA to seek a known method for monitoring the network's health, such as that taught by Al-Ali, which is in the same field and explicitly designed to monitor patient monitoring devices (Al-Ali, para. 0006) to predict issues with network traffic congestion (Al-Ali, para. 0007) and prevent... a lapse in medical care (Al-Ali, para. 0006).
Halac teaches Claim 31.
The method of claim 18, wherein the notification of a predicted disconnection (Col. 17, ll. 20-35, Col. 54, ll. 20-50)
Halac teaches a system that communicates over cellular protocol and monitor quality metric such RSSI, Channel measurements and frequency band in combination with provision of notifications, alerts or warnings, naturally will send notification of a likelihood of loss of cellular network connection by the sensor control device. However, does not specify indicates a likelihood of loss of cellular network connection.
Halac’s cellular connectivity hardware (TRX 510, Halac, Col. 81, ll. 25–67) provides the communication context in which Al-Ali’s predictive alerts about reduced data transfer rate” and “non-responsiveness (Al-Ali [0006]) indicate a likelihood of link loss. The combination would therefore cause Halac’s alert system to issue notifications when congestion or data latency signals an impending disconnection. A PHOSITA would find this integration obvious because Al-Ali explicitly teaches generating predictive warnings before a lapse in medical care (Al-Ali [0006])—precisely the type of preemptive link-loss alert useful in Halac’s remote monitoring framework.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Halac with Al-Ali. Halac's medical system (Halac, Col. 1, ll. 18-24) is critically dependent on a cellular network to provide up to date information and reduce the risk to the user (Halac, Col. 1, ll. 59-64). A POSITA would have been motivated to find a way to make this critical data transmission more reliable by anticipating failures. Al-Ali provides such a solution by teaching a system that monitors network communications (Al-Ali, para. 0006) to predict issues (Al-Ali, para. 0007) specifically to prevent or reduce the likelihood of a lapse in medical care (Al-Ali, para. 0006), thereby providing a clear reason to integrate Al-Ali's predictive logic into Halac's system.
Halac teaches, Claim 32.
The method of claim 31, further comprising
Halac discloses a comprehensive medical telemetry system (Halac, Col. 15, ll. 1–20) designed for continuous physiological monitoring using cellular and other wireless communication channels. It includes a SERVER 334a connected through COMMUNICATION MEDIA 305 (Halac, Col. 16, ll. 50–67), working with device-side modules such as CONNECTIVITY INTERFACE 505 (Halac, Col. 52, ll. 40–67) and TRX 510 (Halac, Col. 81, ll. 25–67) to collect, transmit, and process biological data (e.g., lactate or glucose levels). Halac’s system provides alerts, notifications, and status updates between the sensor device, server, and user interfaces to maintain communication integrity and ensure reliable medical data transmission (Halac, Col. 18, ll. 1–67).
However, Halac fails to teach adjusting a threshold for detecting when a notification of a predicted disconnection of the cellular network is to be sent. Halac's thresholds are related to device activation, not adaptive, predictive network alerts.
Al-Ali teaches the missing element. Al-Ali's system generates a notification by comparing... data with a baseline (Al-Ali, para. 0008). This notification is triggered if the... data deviates from the baseline by a predetermined amount (Al-Ali, para. 0008). This predetermined amount functions as the claimed threshold. The very nature of this threshold, which defines a significant deviation from a baseline that is itself generated from aggregated historical data (Al-Ali, para. [0083]), requires it to be settable or adjustable to tune the system's sensitivity. Al-Ali's own specification provides examples of this threshold as deviating by a certain percentage, deviates by a certain number, etc. (Al-Ali, para. [0086]), which explicitly describes different types of settable (and therefore adjustable) threshold logic. A POSITA would immediately understand that an administrator must be able to set or adjust this "predetermined amount" (e.g., set the percentage or number) to define what constitutes a meaningful deviation, as this is a routine requirement for any network monitoring tool.
Because both address patient-monitoring reliability in networked medical systems, a POSITA would recognize that Al-Ali’s predictive notifier is a compatible, routine enhancement to Halac’s existing alert infrastructure. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results, making the integration of Al-Ali’s predictive module into Halac’s telemetry architecture an expected, field-consistent optimization.
Halac’s server-alert system provides the communication backbone, while Al-Ali’s network monitoring adds the missing predictive logic. When combined, Al-Ali’s disclosure that “network traffic congestion levels may be monitored” and that the system “may notify the appropriate party when a deviation from baseline occurs” (Al-Ali [0007]– [0009]) directly supplies the low-network alert.
Al-Ali explicitly teaches that network issues should be “identified or predicted … before they result in a lapse in medical care,” (Al-Ali, par. 0006-0007) creating a clear design incentive to integrate predictive network alerts into any medical telemetry system, such as Halac’s.
Conclusion
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/JOSHUA DAMIAN RUIZ/Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684