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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 05, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on January 21, 2025 are accepted.
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 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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khanal et al. (US 2022/0400986 A1) (“Khanal”).
Regarding claim 1, Khanal discloses A system comprising (Abstract and entire document):
an analyte measurement system configured to measure an analyte of a patient, the analyte measurement system comprising an analyte sensor (FIG. 1-2, analyte monitoring system 100, sensor 104);
a remote device in communication with the analyte measurement system, wherein the remote device is configured to receive or retrieve sensor data from the analyte sensor (FIG. 1-2, [0087], reader device 120, computer system 170); and
a processor in communication with the remote device, wherein the processor is coupled to a memory storing instructions that when executed cause the processor to (FIG. 1-2, [0087], reader device 120, computer system 170, [0089], processor, memory):
receive and store an order for analyte assessment associated with an electronic medical record (EMR) account of the patient ([0008], [0211] – 0214]);
generate or retrieve a unique identifier associated with the order and the EMR account ([0214 – 0216] and [0228]);
transfer the unique identifier to the remote device ([0210 – 0228]);
activate the analyte measurement system with the remote device and store the unique identifier on the analyte sensor ([0210 – 0228]);
retrieve and store sensor data and the associated unique identifier from the analyte sensor ([0210 – 0228]);
generate a report based on the sensor data ([0210 – 0228]); and
upload the report to the EMR account associated with the unique identifier ([0210 – 0228]).
Regarding claim 2, Khanal discloses The system of claim 1, wherein the processor is configured to activate a professional blinded mode based on the unique identifier such that sensor data is not displayed to the patient ([0240 – 0242]).
Regarding claim 3, Khanal discloses The system of claim 1, wherein communication between the analyte measurement system and the remote device comprises near-field communication (NFC) ([0087]).
Regarding claim 4, Khanal discloses The system of claim 1, wherein the unique identifier comprises a globally unique identifier (GUID), a universally unique identifier (UUID), a unique text string, an analyte sensor serial number, patient information, an identification sticker, a quick-response (QR) code, a two- dimensional (2D) barcode, or a combination thereof ([0210 – 0228], [0228] barcode, [0211], user ID, name, address, etc.).
Regarding claim 5, Khanal discloses The system of claim 4, wherein the unique identifier is coupled to a container configured to return the analyte sensor and/or the remote device to a location of the processor ([0228]).
Regarding claim 6, Khanal discloses The system of claim 4, wherein the unique identifier is coupled to the analyte sensor and/or to a container storing the analyte sensor prior to use ([0228]).
Regarding claim 7, Khanal discloses The system of claim 1, wherein the processor is located at a laboratory test facility ([0212]).
Regarding claim 8, Khanal discloses The system of claim 7, wherein the processor is in communication with: an order interface configured to receive the order from a third party; and a result interface configured to provide the report to the third party ([0212 - 0214]).
Regarding claim 9, Khanal discloses The system of claim 1, wherein the remote device is configured to activate the analyte measurement system based on the unique identifier ([0210 – 0228]).
Regarding claim 10, Khanal discloses The system of claim 9, wherein the analyte measurement system is configured to store the unique identifier ([0210 – 0228]).
Regarding claim 11, Khanal discloses The system of claim 1, wherein the remote device is configured to retrieve the order based on patient information ([0212 - 0214]).
Regarding claim 12, Khanal discloses The system of claim 11, wherein the remote device is configured to: send patient information to the processor, and receive the unique identifier based on a match between the order and the patient information ([0210 – 0228]).
Regarding claim 13, Khanal discloses The system of claim 1, wherein the remote device comprises a second processor configured to monitor a functionality of the analyte measurement system ([0092 - 0093] and [0080).
Regarding claim 14, Khanal discloses The system of claim 13, wherein the second processor is configured to provide a notification to the patient to indicate measurement of the sensor data is complete ([0092 - 0093] and [0080).
Regarding claim 15, Khanal discloses The system of claim 1, wherein the remote device comprises a sensor management device configured to be reusable and/or disposable (FIG. 1-2).
Regarding claim 16, Khanal discloses The system of claim 1, wherein the order is received from a clinic or a health care professional (HCP) ([0212 - 0214]).
Regarding claim 17, Khanal discloses The system of claim 1, wherein the processor is in communication with a database configured to store the order ([0212 - 0214]).
Regarding claim 18, Khanal discloses The system of claim 1, wherein the processor is in communication with a data server configured to store the report ([0212 - 0214]).
Regarding claim 19, Khanal discloses The system of claim 1, wherein the analyte comprises glucose ([0003]).
Regarding claim 20, Khanal discloses The system of claim 1, wherein the analyte comprises multiple analytes ([0003]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH A TOMBERS/ Examiner, Art Unit 3791
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