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 .
DETAILED ACTION
This office action is in response to application filed on May 15, 2025. Claims 1-15 are currently pending in the application.
Drawings
The drawings filed on 05/15/2025 are acknowledged and are acceptable.
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 3, 5, and 10-15 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 pre-AIA the applicant regards as the invention.
Claim 3 recites the limitation "the alert" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the predetermined lactate data limit" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the continuous lactate data" in line 6. There is insufficient antecedent basis for this limitation in the claim. It is presumed to recite "the continuous lactate monitor".
Claims 11-15 are rejected under 35 USC 112(b) due to their dependency on claim 10.
Additionally:
Claim 11 recites the limitations "the analyte data" in lines 2 and 4, and "the data" in line 2. There is insufficient antecedent basis for these limitations in the claim. They are presumed to recite "the lactate data".
Claim 13 recites the limitation "the predetermined lactate data limit" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the analyte data" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is presumed to recite "the lactate data".
Appropriate correction or clarification is requested.
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 of this title, 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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Mensinger et al. (U.S. Publication No. 2014/0184422 A1; hereinafter as, “Mensinger”) in view of Belliveau et al. (U.S. Publication No. 2021/0142912 A1, hereinafter as, “Belliveau”).
As per claim 1, Mensinger discloses a continuous lactate monitoring system (see e.g. Fig. 2A), comprising:
a continuous lactate monitor (e.g., Fig. 2A: sensor with continuous analyte sensor 10 for measuring glucose or lactate, see e.g., para. [0079]: the continuous analyte sensor is configured to continuously detect and/or measure analytes; para. [0080]: describes the sensor as a continuous sensor (including transcutaneous, subcutaneous, implantable, etc.); para. [0081]: the continuous analyte sensor may comprise other types of analyte sensors as well, and other analytes may be used instead or as well including lactate), the continuous lactate monitor (10, 12) configured to generate lactate data based on measured lactate levels (see e.g., para. [0079]-[0081]: the continuous analyte sensor configured to measure lactate necessarily generates lactate measurement data based on measured lactate levels), the continuous lactate monitor (10, 12) having a transmitter (see e.g., Fig. 2A: sensor electronics 12 comprising telemetry module 232, which operates using e.g. Bluetooth, see e.g., par. [0088]) configured to transmit the lactate data (see e.g., para. [0076], [0085] & [0088]: the sensor electronics module includes telemetry for wirelessly transmitting analyte data);
an external transmitter (receiver 102) that is configured to receive the lactate data from the transmitter (12, 232) by wireless transmission (see e.g., para. [0043], [0052], [0072] & [0088]: receiver 102 receiving sensor data wirelessly and gateway 104 receiving data from the receiver); and
a computing device connected to the continuous lactate monitor through the external transmitter (see e.g., para. [0034], [0043]-[0044] & [0072]-[0073]: the gateway (smartphone) communicates with the receiver, which communicates with the sensor), wherein the computing device comprises memory that contains instructions (see e.g., para. [0034], [0036] & [0046]: smartphones executing software applications stored in memory) that cause the computing device to:
receive lactate data from the continuous lactate monitor using the external transmitter (see e.g., para. [0034], [0052] & [0072]-[0073]: receiving analyte/sensor data through the receiver/gateway);
analyze the lactate data to compare the lactate data to a predetermined lactate data condition stored in the memory (see e.g., para. [0035], [0045] & [0053]-[0056]: comparing received glucose/analyte values with predetermined thresholds); and
transmit a notification based on the analysis of the lactate data and the predetermined lactate data condition to a group of recipients, the group of recipients based at least in part on a patient's health status or a patient's physical location (see e.g., para. [0031], [0035]-[0036], [0038], [0040], [0044]-[0045], [0051], [0054]-[0056] & [0059]-[0060]: transmitting notifications when thresholds are exceeded to multiple remote monitors/caretakers).
Mensinger discloses activating the remote monitor application or gateway/receiver application (e.g., para. [0048]-[0049], [0060], [0062] & [0065]) but does not explicitly disclose: wherein at least one of the external transmitter and the computing device are configured to activate the continuous lactate monitor prior to transmission of the lactate data.
However, in the same field of endeavor, Belliveau teaches: wherein at least one of the external transmitter and the computing device are configured to activate the continuous lactate monitor prior to transmission of the lactate data (see e.g., para. [0017]: “The method may further include transmitting the stored glucose concentration values from the transmitter to the HCP device upon receipt of or triggering by an interrogation signal. The interrogation signal may be received by the transmitter from a near field communications device or a Bluetooth low-energy device coupled to the HCP device”; para. [0025]: “The device may be configured to receive a first signal activates the transmitter using an interrogation signal. Following activation, the circuit may extract stored glucose concentration data from the transmitter.”; also see para. [0219]-[0220]).
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 Mensinger to incorporate the teachings of Belliveau to configure the gateway or receiver to activate or wake the sensor communication interface prior to transmission of analyte data in order to conserve battery power, as recognized by Belliveau (para. [0219]).
As per claim 2, claim 1 is incorporated and Mensinger discloses: wherein the instructions further cause the computing device to transmit the notification and/or an alert to a second computing device when the predetermined lactate data condition is triggered (see e.g., para. [0035]-[0036], [0044]-[0045] & [0053]-[0061]: discloses transmitting notifications to a remote monitor (a second computing device) when a threshold condition is met).
As per claim 3, claim 1 is incorporated and Mensinger discloses: wherein the alert is an audible and/or visual alert (see e.g., para. [0060], [0067]-[0068] & [0077]: discloses both visual and audible alerts).
As per claim 4, claim 1 is incorporated and Mensinger discloses: wherein the notification is transmitted by email, text message, or internal message (see e.g., para. [0035]: notification such as a text message; para. [0059]: notification may use email, SMS, tweets, push notification, etc.).
As per claim 5, claim 1 is incorporated and Mensinger discloses: wherein the memory includes a user preference associated with a user of the computing device, optionally wherein the user preference is related to the predetermined lactate data limit (see e.g., para. [0036], [0051] & [0055]: teaches configurable notification rules and thresholds; Although Mensinger does not expressly state “memory includes a user preference”, every configurable smartphone application necessarily stores these settings, and thus would have been obvious).
As per claim 6, claim 5 is incorporated and Mensinger discloses: wherein the user preference is also stored on a remote server such that the user preference can be retrieved by the computing device, optionally wherein the user preference is retrieved using a data network (see e.g., para. [0051] & [0063]-[0065]: teaches server-side configuration).
As per claim 7, claim 1 is incorporated and Mensinger discloses: wherein the memory includes further instructions that cause the processor to transmit the lactate data to a remote server, optionally using a data network (see e.g., para. [0034] & [0052]: receiver sends analyte data and gateway forwards the sensor data to secure server; also see para. [0038]: health monitoring systems transmit health-related data to servers).
As per claim 8, claim 7 is incorporated and Mensinger discloses: the system further comprising a second computing device configured to receive the lactate data from the remote server (see e.g., para. [0031], [0035]-[0036], [0038], [0044] & [0063]-[0066]: remote monitor receives data from secure server; remote monitor retrieves historical and current analyte data).
As per claim 9, claim 1 is incorporated and Mensinger in view of Belliveau discloses: wherein the external transmitter is configured to activate the continuous lactate monitor (see Belliveau, e.g., para. [0017]: “The method may further include transmitting the stored glucose concentration values from the transmitter to the HCP device upon receipt of or triggering by an interrogation signal. The interrogation signal may be received by the transmitter from a near field communications device or a Bluetooth low-energy device coupled to the HCP device”; para. [0025]: “The device may be configured to receive a first signal activates the transmitter using an interrogation signal. Following activation, the circuit may extract stored glucose concentration data from the transmitter.”; also see para. [0219]-[0220]).
Method claims 10-15 are directed to the use of the corresponding system/apparatus recited in claims 1, 2, and 5-7. Therefore, method claims 10-15 are likewise rejected for the same reasons of obviousness discussed above in connection with system claims 1, 2, and 5-7.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Refer to PTO-892, Notice of References Cited for a listing of analogous art.
Karlsson et al. (U.S. Publication No. 2013/0041242 A1) discloses a medical monitoring system for continuous monitoring of the glucose level and the lactate level of a patient.
Headen et al. (U.S. Publication No. 2021/0196206 A1) discloses a system and method for identifying a risk of sepsis based on the lactate concentration levels.
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/ADNAN AZIZ/Primary Examiner, Art Unit 2685 adnan.aziz@uspto.gov
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