DETAILED ACTION
Response to Arguments
Applicant’s arguments filed 9/24/2026 and associated amendments with respect to the drawing objections, claim objections, and rejections under 35 U.S.C. 112 have been fully considered and are persuasive and withdrawn.
The amendments to the specification and the drawings filed 98/24/2026 are acknowledged and entered.
Applicant’s arguments filed 9/24/2026 with respect to the rejection of the claims as being obvious over Estes in view of Heller have been fully considered but they are not persuasive.
Applicant argues that Estes’ y and x are only variables defining a mathematical relationship, and that Estes does not disclose first and second parameter value pre-stored as a pair-data set. Examiner disagrees and submits that Estes stores the sensitivity profile as a look-up table in the computer-readable memory, accessed by the processor ([0253]). With the sensitivity and baseline determined at any given time, Estes forms a conversion function that associates each sensor signal value with an estimated glucose concentration ([0261]). The stored information therefore defines a predetermined association of first parameter values (sensor signal) with second parameter values (estimated glucose concentration), which is a predetermined pair data set.
Applicant argues that Estes assumes a linear relationship whereas the present invention does not assume linearity. Examiner disagrees and submits that the argument is not commensurate in scope with the claimed invention, claim 1 does not exclude a linear association.
Applicant argues that Estes only stores sensitivity values in a lookup table and does not disclose a par-data set of first and second parameter values or a second parameter value associated with in vivo analyte parameter information. Examiner disagrees and submits that Estes’ stored sensitivity information is what associates the sensor signal with the estimated glucose concentration ([0241], [0261]). The estimated glucose concentration comes from a continuous implanted sensor ([0236], [0241]), so the second parameter value is associated with in vivo parameter information.
Applicant argues that the calibration equation contains no time parameters and Estes does not disclose a calibration function based on time parameters. Examiner disagrees and submits that Estes discloses a predetermined sensitivity function that uses time as input ([0013]). The function is stored in memory as an algorithm function or look-up table ([0253]) and estimates sensitivity over the life of the sensor ([0261]), which is a calibration function based on time parameters.
Applicant argues that Estes’ sensitivity-versus-time data points are used only to generate or update a sensitivity profile, and that Estes does not use one parameter value as an index to obtain the second parameter value. Examiner disagrees and submits that Estes’ process accesses the stored look-up table ([0253]) and converts the sensor signal into an estimated glucose concentration ([0261]), which is obtaining the second parameter value based on the first parameter value by an index.
Applicant argues that Estes adjusts the sensitivity profile or its function, not the pair-data itself. Examiner disagrees and submits that Estes forms the conversion function from the sensitivity determined “at any given time during the life of a sensor” ([0261]), and the conversion functions differ over the sensor session ([0248], FIG. 1B). The association between sensor signal and estimated glucose concentration is therefore adjusted by the time-based calibration function.
Applicant argues that Estes does not disclose reusing the adjusted pair data set in a next detection, nor the claimed sequence of retrieving by index, adjusting, and reusing. Examiner disagrees and submits that Estes calibrates iteratively throughout a substantially entire sensor session ([0007]) and continuously adjusts, regenerates, or updates the sensitivity profile during the session ([0267]), meaning each subsequent detection therefore uses the adjusted association, which meets the claimed sequence.
Applicant’s arguments with respect to claim(s) 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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) 1-7, 9-11 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 3,575,796 to Estes et al. (hereinafter, Estes) in view of US 20100094110 A1 to Heller et al. (hereinafter, Heller).
Regarding Claims 1 and 17, Estes discloses an analyte detection device and method, comprising inter alia:
a shell ([0238] “… the sensor extends through a housing, which maintains the sensor on the skin and provides for electrical connection of the sensor to sensor electronics.”);
a sensor comprising an internal part used to penetrate into a subcutaneous skin to obtain a first parameter value ([0236] “The continuous analyte sensor can be a subcutaneous…”) ([0210] “… a working electrode measures hydrogen peroxide (H 2O2) creating a measurable electronic current.”) and an external part ([0236] “…the continuous analyte sensor system may be comprised of a combination of a subcutaneous device and a transdermal device, a combination of a subcutaneous device and an intravascular device…”);
a memory ([0033] “… the plurality of different sensitivity values are stored in a lookup table in computer memory.”) in which at least a predetermined pair-data set composed of the first parameter value (e.g., measurable electronic current detected by the working electrode in [0210]) ([0241] “… y represents the sensor signal (counts)…”) and a second parameter value ([0241] “… x represents the estimated glucose concentration (mg/dl)…”) and a predetermined calibration function based on time parameters are pre stored ([0241] “… calibration of the sensor is obtained by solving the equation: y = mx + b…”), wherein the second parameter value is associated with an in vivo analyte parameter information ([0241] “… x represents the estimated glucose concentration (mg/dl)…”);
a processor programmed to call the predetermined pair-data set ([0253] “The algorithm function or look-up table can be stored in a computer-readable memory, for example, and accessed by a computer processor.”) and the predetermined calibration function from the memory ([0013] “… the a priori information is associated with a predetermined sensitivity function that uses time as input.”), to obtain the second parameter value based on the first parameter value by an index ([0253] “… the sensor sensitivity profile can be transformed into an estimative algorithm function or alternatively into a lookup table. The algorithm function or look-up table can be stored in a computer-readable memory, for example, and accessed by a computer processor.”) ([0261] “…a sensor signal is converted into an estimated glucose concentration.”), predetermined pair-data set is adjusted by predetermined calibration function ([0267] “… the sensor sensitivity profile can be continuously adjusted, regenerated, or updated to account for parameters that may affect sensor sensitivity or provide additional information about sensor sensitivity during the sensor session.”), wherein the predetermined pair-data set is callable by the processor in a next detection ([0007] “… calibrating the sensor data is performed iteratively throughout a substantially entire sensor session.”);
a transmitter used to transmit the first parameter value and/or the second parameter value to a remote equipment ([287] “The transmitter may be used to transmit the first and second signals to a receiver, where additional data analysis and/or calibration of analyte concentration can be processed.”).
Estes discloses the claimed invention except for expressly disclosing a battery, which is used to provide electric energy. While Estes discloses that power is supplied in [0217], Estes does not expressly disclose what the source of power is. However, Heller teaches a blood glucose monitoring unit (Abstract) that is powered by a batter ([0008]). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the power that is supplied in Estes to be supplied by the battery of Heller, because Heller states that the batter would be suitable for operating the device ([0216]). Furthermore, a skilled artisan would have recognized that using a battery as the power supply would have notoriously obvious in the art, because batteries are well known power supplies in wearable glucose monitoring devices to allow for portability.
Regarding Claim 2, Estes in view of Heller teach wherein the first parameter value is a current value or a voltage value (Estes [0219] “…the raw data stream is digital data in counts converted by an AID converter from an analog signal (for example, voltage or amps) representative of an analyte concentration.”).
Regarding Claim 3, Estes in view of Heller teach wherein the second parameter value comprises a blood glucose concentration value (Estes [0241] “… x represents the estimated glucose concentration (mg/dl)…”).
Regarding Claim 4, Estes in view of Heller teach wherein the predetermined pair-data set is at least partially derived from in vivo tests (Estes [0251] “The estimative algorithm function may be generated by testing a sample set (comprising one or more sensors) from a sensor lot under in vivo and/or in vitro conditions.”).
Regarding Claim 5, Estes in view of Heller teach wherein the predetermined pair-data set is at least partially derived from in vitro tests (Estes [0251] “The estimative algorithm function may be generated by testing a sample set (comprising one or more sensors) from a sensor lot under in vivo and/or in vitro conditions.”).
Regarding Claim 6, Estes in view of Heller teach wherein at least some of pair-data in the predetermined pair-data set is adjustable based on a physical characteristics of the sensor (Estes [0016] “In an embodiment of the first aspect or any other embodiment thereof, the sensitivity value of the continuous analyte sensor is also a function of at least one other parameter.”) (Estes [0017] “In an embodiment of the first aspect or any other embodiment thereof, the at least one other parameter is selected from the group consisting of: temperature, pH, level or duration of hydration, curing condition, an analyte concentration of a fluid surrounding the continuous analyte sensor during startup of the sensor, and combinations thereof.”).
Regarding Claim 7, Estes in view of Heller teach wherein the physical characteristics of the sensor comprise at least one of a membrane thickness, an active enzyme area, an active enzyme volume or a resistance of an electrode (Estes [0242] “… parameters can affect sensor sensitivity or provide additional information about sensor sensitivity prior to the sensor session, such as parameters associated with the sensor fabrication (e.g., materials used to fabricate sensor membrane, the thickness of the sensor membrane…”).
Regarding Claim 9, Estes in view of Heller teach wherein an adjustment of the at least some of the of pair-data is changed in a linear manner (Estes [0406] Laboratory experiments showed that there is an inverse relationship between the changes in sensor sensitivity (drift) and the changes in impedance. Based on the measured impedance, the sensor sensitivity drift could be compensated using either linear or non-linear sensor sensitivity-impedance correlation.)
Regarding Claim 10, Estes in view of Heller teach wherein the first parameter value or the second parameter value is set with at least one threshold, wherein when the first parameter value or the second parameter value exceeds the threshold, the remote equipment sends an alert indication (Estes [0342] “Then, at decision step 2110, the calculated impedance is compared to a predetermined threshold. Should it be determined that the impedance exceeds the threshold, then a sensor reuse routine is initiated at step 2112. If it is determined in decision step 2110 that the impedance does not exceed the threshold, then the process 2100 ends at step 2114” Where the reuse routine is the alert indication.)
Regarding Claim 11, Estes in view of Heller teach wherein the threshold is set by a user or a non-user (Estes [0326] describes a “predetermined threshold amount”).
Regarding Claim 13, Estes in view of Heller teach wherein the first parameter value in the first predetermined pair-data set or the second predetermined pair-data set is a continuous range interval (Estes [0219] “…the raw data stream is digital data in counts converted by an AID converter from an analog signal (for example, voltage or amps) representative of an analyte concentration…”), wherein the second parameter value is obtained by judging the range interval in which the first parameter value falls with indexing (Estes [0253] “…the sensor sensitivity profile can be transformed into an estimative algorithm function or alternatively into a lookup table. The algorithm function or look-up table can be stored in a computer-readable memory, for example, and accessed by a computer processor.”) (Estes [0261] “…a sensor signal is converted into an estimated glucose concentration.” e.g., indexing a continuous sensor signal value into a lookup table entails determining the range/interval into which the value falls and returning the paired second parameter value (estimated glucose concentration) associated with that interval.).
Regarding Claim 15, Estes in view of Heller teach wherein the transmitter, the sensor and the battery are located in the shell, and the memory and/or the processor are located in the remote equipment (Estes [0238] "...the sensor extends through a housing, which maintains the sensor on the skin and provides for electrical connection of the sensor to sensor electronics.") (Estes [0287] "The transmitter may be used to transmit the first and second signals to a receiver...") (Heller [0008], [0216] teaching the battery relied upon in claim 1. Where the sensor, transmitter, and battery are located together in the on-body shell to power the wearable device, for the reasons set forth above. ), and the memory and/or the processor are located in the remote equipment (Estes [0287] "The transmitter may be used to transmit the first and second signals to a receiver, where additional data analysis and/or calibration of analyte concentration can be processed." Where the receiver is the remote equipment and the processor performing the data analysis/calibration is located therein.).
Regarding Claim 16, Estes in view of Heller teach wherein at least two of the transmitter, the processor and the memory are integrated (all elements of the device of Estes are, especially as broadly claimed, “integrated”, because they are of the same device).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Estes in view of Heller, and further in view of US 20150068926 A1 to Ainger et al. (hereinafter, Ainger).
Estes in view of Heller teach claim 1, but do not expressly disclose where the first parameter value in the first predetermined pair-data set or the second predetermined pair-data set is a continuous range interval, wherein the second parameter value is obtained by judging the range interval in which the first parameter value falls with indexing.
However, Ainger teaches where the first parameter value (stored reference current values) in a first pre-determined pair-data set (Look-Up Table (LUT)) is a continuous range interval, where a second parameter value (blood plasma glucose value BGraw) is obtained by judging the range interval in which the first parameter value falls with indexing ([0160] compare respective contemporaneously measured current (decaying) values… with stored reference current values, to identify the closest match… and to retrieve an associated blood plasma glucose value "BG.sub.raw" from the LUT associated with that match”, e.g., identifying the closest stored reference current determines the continuous interval, bounded by the midpoints between adjacent stored reference currents, in which the measured current falls).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the pair-data set of Estes in view of Heller with the closest-match look-up of Ainger, so that the processor retrieves the glucose value for any measured sensor current directly from stored reference data measured at known glucose concentrations (Ainger, [0158] “from which a future blood plasma glucose measurement may be made by reference”).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
