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 October 13, 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 September 25, 2024 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 1-8 and 12-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hua et al. (US 2022/0150308 A1) (“Hua”).
Regarding claim 1, Hua discloses An analyte monitoring system comprising (Abstract and entire document):
an analyte sensor configured to monitor an analyte level, wherein at least a portion of the analyte sensor is configured to be positioned in contact with a bodily fluid of a subject (FIG. 1, analyte sensor 110),
wherein the analyte sensor comprises a communication module (FIG. 1 and [0042 – 0049] communication module);
a first receiver device wirelessly coupled to the communication module of the analyte sensor and configured to receive analyte data from the analyte sensor (FIG. 1, dedicated data receiving device 120); and
one or more second receiver devices wirelessly coupled to the communication module of the analyte sensor (FIG. 1, multi-purpose data receiving device 130);
wherein the analyte sensor is configured to be arranged in a star network topology with the first receiver device and the one or more second receiver devices, wherein the analyte sensor is at a center of the star network topology (FIG. 1 and 6B and associated paragraphs, sensor 110 is the central hub to the first receiver device and the one or more second receiver devices, see at least [0112 – 0113]).
Regarding claim 2, Hua discloses The analyte monitoring system of claim 1, wherein the analyte data comprises data corresponding to analyte levels of: glucose, ketones, lactate, oxygen, hemoglobin A1C, albumin, alcohol, alkaline phosphatase, alanine transaminase, aspartate aminotransferase, bilirubin, blood urea nitrogen, calcium, carbon dioxide, chloride, creatinine, hematocrit, lactate, magnesium, oxygen, pH, phosphorus, potassium, sodium, total protein, or uric acid ([0034]).
Regarding claim 3, Hua discloses The analyte monitoring system of claim 1, wherein the first receiver device is further configured to receive a list identifying each of the one or more second receiver devices wirelessly coupled to the communication module of the analyte sensor ([0123], “From the connection request, the sensor 110 identifies the data receiving device 125b (e.g., using a BLE handle for the data receiving device 125b included in the connection request) and a mechanism to use to initiate the connection. For example, the connection request can include a security algorithm type to be used for the connection or a communication channel or channel-hopping scheme to use to facilitate the connection. The sensor 110 can determine if the data receiving device 125b has previously initiated a connection with the sensor 110 to expedite the connection procedure. For example, the sensor 110 can store a mapping table of devices with which it has connected. The mapping table can include identifiers or handles for the devices and a locally assigned identifier (e.g., an index in the table) generated by the sensor 110 to act as a shorthand to reference the device in the future.”).
Regarding claim 4, Hua discloses The analyte monitoring system of claim 3, wherein the first receiver device is further configured to, upon receiving an indication that a new analyte sensor is activated, transmit the list to the new analyte sensor so as to facilitate wireless coupling between the new analyte sensor and the one or more second receiver devices ([0123], “If the identifier for the data receiving device 125b does not appear in the mapping table, the sensor 110 can generate a new entry for the data receiving device 125b and proceed to establish a pairing with the data receiving device 125b.”).
Regarding claim 5, Hua discloses The analyte monitoring system of claim 1, wherein at least one of the one or more second receiver devices is a fitness monitor or a fitness device ([0039]).
Regarding claim 6, Hua discloses The analyte monitoring system of claim 1, wherein at least one of the one or more second receiver devices comprises medical components for use by the subject based on the analyte data ([0039]).
Regarding claim 7, Hua discloses The analyte monitoring system of claim 1, wherein at least one of the one or more second receiver devices is a smartphone or a smartwatch ([0039]).
Regarding claim 8, Hua discloses The analyte monitoring system of claim 1, wherein at least one of the one or more second receiver devices is a server (FIG. 1, remote server 150).
Regarding claim 12, Hua discloses An analyte sensor comprising (Abstract and entire document):
a sensing hardware configured to be positioned in contact with a bodily fluid of a subject (FIG. 1, analyte sensor 110); and
a communication module configured to wirelessly couple the analyte sensor to a first receiver device and one or more second receiver devices, wherein the communication module is further configured to transmit analyte data to at least the first receiver device (FIG. 1 and [0042 – 0049] communication module; FIG. 1, dedicated data receiving device 120; multi-purpose data receiving device 130);
wherein the analyte sensor is configured to be arranged in a star network topology with the first receiver device and the one or more second receiver devices, wherein the analyte sensor is at a center of the star network topology (FIG. 1 and 6B and associated paragraphs, sensor 110 is the central hub to the first receiver device and the one or more second receiver devices, see at least [0112 – 0113]).
Regarding claim 13, Hua discloses The analyte sensor of claim 12, wherein the analyte data comprises data corresponding to analyte levels of: glucose, ketones, lactate, oxygen, hemoglobin A1C, albumin, alcohol, alkaline phosphatase, alanine transaminase, aspartate aminotransferase, bilirubin, blood urea nitrogen, calcium, carbon dioxide, chloride, creatinine, hematocrit, lactate, magnesium, oxygen, pH, phosphorus, potassium, sodium, total protein, or uric acid ([0034]).
Regarding claim 14, Hua discloses The analyte sensor of claim 12, wherein the communication module is further configured to transmit a list identifying each of the one or more second receiver devices wirelessly coupled to the communication module ([0123], “From the connection request, the sensor 110 identifies the data receiving device 125b (e.g., using a BLE handle for the data receiving device 125b included in the connection request) and a mechanism to use to initiate the connection. For example, the connection request can include a security algorithm type to be used for the connection or a communication channel or channel-hopping scheme to use to facilitate the connection. The sensor 110 can determine if the data receiving device 125b has previously initiated a connection with the sensor 110 to expedite the connection procedure. For example, the sensor 110 can store a mapping table of devices with which it has connected. The mapping table can include identifiers or handles for the devices and a locally assigned identifier (e.g., an index in the table) generated by the sensor 110 to act as a shorthand to reference the device in the future.”).
Regarding claim 15, Hua discloses The analyte sensor of claim 12, wherein the communication module is further configured to, prior to wirelessly coupling to the one or more second receiver devices, receive a list of the one or more second receiver devices to which the analyte sensor is to be wirelessly coupled to ([0123], “If the identifier for the data receiving device 125b does not appear in the mapping table, the sensor 110 can generate a new entry for the data receiving device 125b and proceed to establish a pairing with the data receiving device 125b.”).
Regarding claim 16, Hua discloses The analyte sensor of claim 12, wherein at least one of the one or more second receiver devices is a fitness monitor, a fitness device, a smartphone, a smartwatch, or a server ([0039]).
Regarding claim 17, Hua discloses The analyte sensor of claim 12, wherein at least one of the one or more second receiver devices comprises medical components for use by the subject based on the analyte data ([0039]).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 9-11 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hua in view of Lee et al. (US 2022/0240819 A1) (“Lee”).
Regarding claim 9 and 18, Hua discloses The analyte monitoring system of claim 1, Hua fails to disclose wherein the analyte sensor is further configured to determine, based on the analyte data, whether a monitored analyte level satisfies an alarm condition.
However, in the same field of endeavor, Lee teaches wherein the analyte sensor is further configured to determine, based on the analyte data, whether a monitored analyte level satisfies an alarm condition ([0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device/system as taught by Hua to include wherein the analyte sensor is further configured to determine, based on the analyte data, whether a monitored analyte level satisfies an alarm condition as taught by Lee to provide rapid access to important information ([0012]).
Regarding claims 10 and 19, Hua discloses The analyte monitoring system of claim 9, Hua as modified further discloses wherein the alarm condition is specified to the analyte sensor by a particular receiver device of the first or second receiver devices (Lee [0072]).
Regarding claims 11 and 20, Hua discloses The analyte monitoring system of claim 10, Hua as modified further discloses wherein the analyte sensor is further configured to, upon determining that the monitored analyte level satisfies the alarm condition, send a notification message to the particular receiver device (Lee [0072]).
Claims 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Hua in view of Burnette et al. (US 2017/0181628 A1) (“Burnette”) in further view of Lee.
Regarding claim 21, Hua discloses An analyte monitoring system comprising (Abstract and entire document):
a first analyte sensor configured to monitor an analyte level, wherein at least a portion of the first analyte sensor is configured to be positioned in contact with a bodily fluid of a subject (FIG. 1, analyte sensor 110),
wherein the first analyte sensor comprises a communication module (FIG. 1 and [0042 – 0049] communication module);
a first receiver device wirelessly coupled to the communication module of the first analyte sensor and configured to receive analyte data from the first analyte sensor (FIG. 1, dedicated data receiving device 120); and
one or more second receiver devices wirelessly coupled to the communication module of the first analyte sensor (FIG. 1, multi-purpose data receiving device 130);
wherein the first analyte sensor is configured to be arranged in a star network topology with the first receiver device and the one or more second receiver devices, wherein the first analyte sensor is at a center of the star network topology (FIG. 1 and 6B and associated paragraphs, sensor 110 is the central hub to the first receiver device and the one or more second receiver devices, see at least [0112 – 0113]);
wherein the first receiver device is configured to receive from the first analyte sensor data that identifies the one or more second receiver devices communicatively coupled to the communication module of the first analyte sensor, the first receiver device being configured to maintain a list of the one or more second receiver devices communicatively coupled to the communication module of the first analyte sensor ([0123], “From the connection request, the sensor 110 identifies the data receiving device 125b (e.g., using a BLE handle for the data receiving device 125b included in the connection request) and a mechanism to use to initiate the connection. For example, the connection request can include a security algorithm type to be used for the connection or a communication channel or channel-hopping scheme to use to facilitate the connection. The sensor 110 can determine if the data receiving device 125b has previously initiated a connection with the sensor 110 to expedite the connection procedure. For example, the sensor 110 can store a mapping table of devices with which it has connected. The mapping table can include identifiers or handles for the devices and a locally assigned identifier (e.g., an index in the table) generated by the sensor 110 to act as a shorthand to reference the device in the future.”);
wherein the first analyte sensor communicatively coupled to one of the second receiver devices via a server (FIG. 1, remote server 150).
Hua fails to disclose wherein the first receiver device is configured with a user interface that includes a selectable button for adding a second analyte sensor to the star network topology, which when added to the star network topology, the first receiver device is further configured to transmit the list of the one or more second receiver devices to the second analyte sensor;
wherein the first analyte sensor is configured to receive alarm conditions from one or more of the second receiver devices and further configured to monitor an analyte level based on the alarm conditions, wherein the first analyte sensor is configured to transmit notifications to one or more of the second receiver devices upon determining that the alarm conditions are satisfied;
However, in the same field of endeavor, Burnette teaches wherein the first receiver device is configured with a user interface that includes a selectable button for adding a second analyte sensor to the star network topology, which when added to the star network topology, the first receiver device is further configured to transmit the list of the one or more second receiver devices to the second analyte sensor ([0068]);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Hua to include wherein the first receiver device is configured with a user interface that includes a selectable button for adding a second analyte sensor to the star network topology, which when added to the star network topology, the first receiver device is further configured to transmit the list of the one or more second receiver devices to the second analyte sensor as taught by Burnette to improve convenience ([0028]).
Hua as modified fails to disclose wherein the first analyte sensor is configured to receive alarm conditions from one or more of the second receiver devices and further configured to monitor an analyte level based on the alarm conditions, wherein the first analyte sensor is configured to transmit notifications to one or more of the second receiver devices upon determining that the alarm conditions are satisfied;
However, in the same field of endeavor, Lee teaches wherein the first analyte sensor is configured to receive alarm conditions from one or more of the second receiver devices and further configured to monitor an analyte level based on the alarm conditions, wherein the first analyte sensor is configured to transmit notifications to one or more of the second receiver devices upon determining that the alarm conditions are satisfied ([0072]);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Hua as modified to include wherein the first analyte sensor is configured to receive alarm conditions from one or more of the second receiver devices and further configured to monitor an analyte level based on the alarm conditions, wherein the first analyte sensor is configured to transmit notifications to one or more of the second receiver devices upon determining that the alarm conditions are satisfied as taught by Lee to provide rapid access to important information ([0012]).
Regarding claim 22, Hua as modified discloses The analyte monitoring system of claim 21, Hua as modified further discloses wherein the analyte data comprises data corresponding to analyte levels of: glucose, ketones, lactate, oxygen, hemoglobin A1C, albumin, alcohol, alkaline phosphatase, alanine transaminase, aspartate aminotransferase, bilirubin, blood urea nitrogen, calcium, carbon dioxide, chloride, creatinine, hematocrit, lactate, magnesium, oxygen, pH, phosphorus, potassium, sodium, total protein, or uric acid ([0034]).
Regarding claim 23, Hua as modified discloses The analyte monitoring system of claim 21, Hua as modified further discloses wherein at least one of the one or more second receiver devices is a fitness monitor or a fitness device ([0039]).
Regarding claim 24, Hua as modified discloses The analyte monitoring system of claim 21, Hua as modified further discloses wherein at least one of the one or more second receiver devices comprises medical components for use by the subject based on the analyte data ([0039]).
Regarding claim 25, Hua as modified discloses The analyte monitoring system of claim 21, Hua as modified further discloses wherein at least one of the one or more second receiver devices is a smartphone or a smartwatch ([0039]).
Regarding claim 26, Hua as modified discloses The analyte monitoring system of claim 21, Hua as modified further discloses wherein at least one of the one or more second receiver devices is a server (FIG. 1, remote server 150).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Van Tassel et al. (US 2020/0375457 A1).
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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