DETAILED ACTION
Election/Restrictions
Claims 8, 9 and 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/9/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/9/2026 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 are objected to because the drawings in the figures, including many of the lines defining the structure of the device, text, and shading of the device as generally poorly defined and pixelated. For example, the structure of the device in FIGS. 1-5c is difficult to see, and the reference numerals are pixelated and not clear, the lines and shading in FIG. 8 make the device difficult to see, the text in FIGS. 9-11, 13a-b, 17 and 18 is difficult to see. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2-7, 10, 11, 16 and 17 are objected to because of the following informalities: The better align with US Practice, claims 2-7, 10, 11, 16 and 17 should be amended to read: “The analyte device according to claim X…”.
Claim 1, line 11 should be amended from “adjusted by predetermined” to “adjusted by the predetermined”.
Appropriate correction is required.
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 1-7, 10, 11, 16 and 17 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.
Regarding Claim 1, the limitation “a processor programmed to call the predetermined pair-data set and the predetermined calibration function from the memory, obtaining the second parameter value based on the first parameter value by an index, and the predetermined pair-data set is adjusted by predetermined calibration function, wherein the predetermined pair-data set is callable by the processor in a next detection” is worded in a manner that is grammatically confusing. While it is understood that the processor is “programmed to call the predetermined pair-data set and the predetermined calibration function from the memory” the limitation “obtaining the second parameter value based on the first parameter value by an index” renders the claim indefinite (e.g., Is the “processor programmed to call the predetermined pair-data set and the predetermined calibration function from the memory” what performs the obtaining of “the second parameter value based on the first parameter value by an index”? What is meant by the second parameter being obtained based on the first parameter value?)
and the predetermined pair-data set is adjusted by predetermined calibration function, wherein the predetermined pair-data set is callable by the processor in a next detection
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, 10, 11, 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 3,575,796 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.”), obtaining 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.”), and the 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 according to the analyte detection device mentioned in claim 1, 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 according to the analyte detection device mentioned in claim 1, 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 according to the analyte detection device mentioned in claim 1, 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 according to the analyte detection device mentioned in claim 1, 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 according to the analyte detection device mentioned in claim 1, 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 according to the analyte detection device mentioned in claim 6, 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 10, Estes in view of Heller teach according to the analyte detection device mentioned in claim 1, 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 according to the analyte detection device mentioned in claim 12, wherein the threshold is set by a user or a non-user (Estes [0326] describes a “predetermined threshold amount”).
Regarding Claim 16, Estes in view of Heller teach according to the analyte detection device mentioned in claim 1, 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).
Conclusion
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
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