DETAILED ACTION
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 4-10, 12-13, and 16-21 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.
As to claims 4, 5, 8, 9, 10, 12, 18, 19 and 21, these claims recite “data indicative of the measurements” whereas the claims they depend upon recite “data associated with the measurements” and thus lack antecedent basis.
Claims 5 and 19 recites “other indicia of blood glucose levels” apart from analyte measurement trends and blood glucose measurements themselves. It’s not clear what the scope of “other indicia of blood glucose levels” comprises.
Claims 6 and 11 recites the limitation "the analyte". There is insufficient antecedent basis for this limitation in the claim. It is noted that claims 2 and 16 recite “analyte levels” but not “an analyte”.
Claim 16 recites “a display device” in both the first and last steps. It is not clear whether this is the same display device or separate and distinct devices.
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.
Claim(s) 2-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 2016/0183854) in view of Sloan (US 2015/0341438).
As to claims 2 and 16, Lee teaches an analyte monitoring system and corresponding method (100), comprising: a sensor (104) configured to acquire measurements indicative of analyte levels of a user ([0054]), wherein the sensor is factory calibrated without interaction with the user ([0126]); sensor electronics circuitry (251) communicatively coupled to the factory calibrated sensor (Fig. 2B), the sensor electronics circuitry configured to: receive the measurements indicative of analyte levels from the factory calibrated sensor ([0069]); and periodically communicate data associated with the measurements indicative of analyte levels to the display device via Bluetooth Low Energy (BLE) ([0072]).
Lee fails to expressly teach that the sensor electronics is configured to receive, from a display device, a transmission to start a sensor session via a near field communication (NFC) protocol; wherein the sensor electronics circuitry is configured to start the measurements via the factory calibrated sensor and periodically communicate the data after a predetermined time delay after the transmission via the NFC protocol, the predetermined time delay being set by the analyte monitoring system.
Sloan teaches said limitations. Sloan discloses that the reader device can start up or activate a sensor control device, then pair with it ([0032]) using an NFC protocol ([0008]), with an activation time in which the device is initialized, including a predetermined “warm-up” period ([0057-0058]) in which the glucose values are withheld until its expiration ([0058]). It would have been obvious to modify Lee with Sloan to utilize a known communications protocol to initiate a sensor session for obtaining measurements and to communicate data after a delay to prevent the use of data during a time period in which the data may not be accurate.
As to claims 3 and 17, Sloan teaches the predetermined time delay comprises a warm up period during which the factory calibrated sensor begins initialization after the sensor electronics circuitry wakes up from a low power mode ([0058]).
As to claims 4 and 18, Lee teaches wherein the sensor electronics circuitry is configured to perform signal processing on the measurements periodically between the periodic communications of data indicative of the measurements ([0069-72]).
As to claims 5 and 19, Lee teaches the signal processing performed by the sensor electronics circuitry includes data aggregation where the measurements taken since the last communication of data indicative of the measurements are compiled and processed to determine analyte measurements trends, blood glucose measurements, and/or other indicia of blood glucose levels ([0069], [0162]).
As to claim 6, Lee teaches the analyte is glucose ([0021]), and the signal processing performed by the sensor electronics circuitry includes using a conversion function to convert measured data into estimated glucose values (Lee incorporates by reference US 2011/0213225 in [0052] which teaches that the sensor device obtains raw current signals in [0183] and uses them to provide data associated with the glucose level in [0240]).
As to claim 7, Lee teaches the signal processing performed by the sensor electronics circuitry includes determining a medical state of the user and initiating an alarm or notification. (Lee incorporates by reference US 2011/0213225, which teaches that the body electronics (110) detects an alarm condition ([0104] – such as hyper or hypoglycemia), it generates output indications ([0104]).
As to claim 8, Lee teaches the display device is configured to calculate estimated analyte values based on the data indicative of the measurements received from the sensor electronics circuit (as noted for claim 6 above, Lee teaches the use of an amperometric device by incorporation of the ‘225 reference, which measures current. Accordingly, the results obtained in glucose values are estimates based on the sensor raw data).
As to claim 9, Lee teaches the display device is further configured for alarming based on the data indicative of the measurements received from the sensor electronics circuitry (Lee incorporates by reference US 2011/0213225, which teaches that the display device 120 can output alarm and other output indications visually or audibly ([0190]).
As to claims 10 and 21, Lee teaches a time period between consecutive communications of data indicative of the measurements via Bluetooth Low Energy (BLE) is 5 minutes or less ([0072]).
As to claim 11, Lee teaches the analyte is glucose ([0021]), and the factory calibrated sensor is a transcutaneous glucose sensor ([0044], [0053]).
As to claim 12, Lee teaches the display device is configured to send a command using NFC to the sensor electronics circuitry to cause the sensor electronics circuitry to send data indicative of the measurements to the display device via NFC, and the sensor electronics circuitry is further configured to send the data indicative of the measurements to the display device via NFC in response to the command ([0073-74],[0093] – reader sends a transmission prompting sensor control device to communicate its data, including by NFC).
As to claim 13, Lee teaches the display device is further configured to create a RF field via NFC to transfer energy wirelessly from the display device to the sensor electronics circuitry, and the sensor electronics circuitry is further configured to transmit the data indicative of the measurements using NFC by using the energy transferred wirelessly from the display device (Lee incorporates by reference US 2011/0213225, which teaches that the body electronics includes an inductive power loop antenna 1360 for power transmission ([0164]) via use of RFID ([0243]; the examiner notes that while this ‘225 publication does not mention NFC directly, the 13.56 MHz RFID antenna it mentions in [0243] and elsewhere is the exact center frequency of NFC, which is a type of RFID, and Lee also teaches NFC directly in [0049]).
As to claim 14, Sloan teaches the predetermined time delay is set by the sensor electronics circuitry ([0058]).
As to claim 15, Sloan teaches the predetermined time delay is set by the display device ([0077] – the reader tracks the time it exits the initialization period).
As to claim 20, Lee teaches that the calibration parameters are stored in the sensor control device ([0126]) and that the reader scans the sensor control device over NFC ([0073]) and Sloan teaches an NFC reader in the display device [0051]). Accordingly, the combination teaches reading, via an NFC reader in the display device, calibration information from a passive NFC tag incorporated into the sensor electronics circuitry.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Love (US 2016/0331232) teaches a sensor system in which a sensor session is initiated by an NFC transmission and followed by a predetermined delay before obtaining measurements. Bailey et al. (“The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System”) discusses the use of the FreeStyle Libre glucose sensor system, which is factory-calibrated (p791) and reader scanning (p793).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 10/1/26
