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 .
Status of Claims
This action is in response to Applicant’s amendments and remarks filed July 6, 2026.
Claims 7-16 and 19-20 remain withdrawn.
Claims 1 and 6 have been amended.
Claims 1-6 and 17-18 are currently under examination.
Response to Arguments
Applicant's arguments filed July 6, 2026 have been fully considered but they are not persuasive.
Applicant argues that Smeys does not disclose co-location of the reservoir(s), fluid delivery mechanism, sensing mechanism, and controller in a single housing because the CGM component is a separate functional module. This argument is not persuasive.
Smeys discloses an integrated wearable pod 102 that includes a reservoir 104, pumping unit 106, microcontroller unit (MCU) 108, insulin delivery needle 110, glucose monitoring components 112 including a CGM, a sensor and needle (percutaneously inserted into the patient, and battery and power controller 114 as part of a single autonomous unit. (see figs. 1, 6, and 7; para [0025]). All components cited above are associated with pod 102 and appear inside of pod 102.
Applicant argues that Windmiller is a stand-alone analyte-monitoring-only device whose signal processing architecture is inseparable from that context and cannot be combined with Smeys without hindsight. Applicant further contends that Smeys uses a self-contained CGM module that delivers pre-processed data, providing no interface for Windmiller’s raw-signal chain. These arguments are not persuasive.
In view of the amendment adding the signal processing limitations, the previous §102(a)(1) rejection of claim 1 over Smeys alone is withdrawn. However, the combination of Smeys and Windmiller renders the claimed subject matter obvious under §103.
Smeys discloses the base device with a controller (MCU 108) that analyzes glucose data for closed-loop control (para [0024]). Windmiller teaches the signal processing chain – an amplifier, multiplexer, and analog-to-digital (ADC) converter – for handling raw electrochemical signals from sensing elements in a body-worn, wearable device (analog front-end description).
The claims do not recite or require collection of only pre-processed data versus raw signals from the sensing mechanism. It would have been obvious to incorporate Windmiller’s signal processing chain into Smeys’ pod and controller in order to enable direct, accurate acquisition and digitization of low-level electrochemical signals from the sensing mechanism, allowing the existing MCU to perform algorithmic analysis for improved closed-loop dosing in a compact wearable single-package system (Smeys, para [0025 - 0030].; Windmiller background on continuous monitoring and fault detection). One of ordinary skill would have had a reasonable expectation of success because analog front-end circuitry is a routine, modular component in wearable medical devices, and both references address similar electrochemical sensing needs in diabetes management systems. This is not a fundamental redesign or hindsight – the combination flows naturally from the desire for a fully integrated single package AID system.
Applicant argues that the proposed combination would require a fundamental redesign of Smeys’ core sensing architecture, change its principle of operation, and that a skilled artisan would have had no reasonable expectation of success. Applicant further contends that the Examiner’s stated motivation relies on impermissible hindsight. These arguments are not persuasive.
The motivation to combine is not hindsight but is grounded in the references themselves and the problem they both address: providing accurate analyte sensing for automated drug delivery in a wearable device. Smeys explicitly seeks closed-loop control using glucose data (para [0025 – 0030]). Windmiller provides a proven, low-power signal processing solution for electrochemical sensing in body-worn devices. Combining them to enable direct signal processing with Smeys’ integrated pod is a predictable improvement that maintains the principle of operation (closed-loop AID) while enhancing signal fidelity.
One of ordinary skill in the art – familiar with wearable medical device design – would have had a reasonable expectation of success because analog front-end integration is routine, modular electronics work, and both references operate in the same field of diabetes management devices. No fundamental redesign is required; the combination is a straightforward application of known techniques to a known device for predictable results.
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.
Claims 1 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Smeys (US Publication No. 2022/0409051), hereinafter, Smeys, in view of Windmiller (US Publication No. 20220370011), hereinafter, Windmiller.
Regarding claim 1, Smeys discloses a device (Smeys; infusion system 100 in fig. 1) comprising: a housing (Smeys; device or pod 102 in fig. 1; para [0024], fully autonomous and integrated wearable unit for diabetes management);
one or more reservoirs (Smeys; reservoir 104 in fig. 1) disposed in the housing (Smeys; para [0025], device 102 includes reservoir 104);
a fluid delivery mechanism for delivering a fluid (Smeys; pumping unit or element 106 with its valves, actuators, sensors, pumping chamber, fluid channels shown in fig. 2A, and insulin needle 110 that enters the body in fig. 1) from the one or more reservoirs to a user (Smeys; para [0027], pump fluidly communicates with reservoir 104 and insulin needle 110 for insulin delivery);
a sensing mechanism (Smeys; glucose monitoring components 112 in fig. 1) for sensing an analyte level of the user (Smeys; para [0025], a sensor and needle track patient glucose levels);
a controller for analyzing the sensed analyte levels (Smeys; microcontroller unit (MCU) 108 and battery power controller 114), determining a quantity and timing of delivery of the fluid and controlling the delivery mechanism to deliver the fluid to the user (Smeys; para [0025], a sensor and needle tracks patient glucose levels and permits those levels to be used in algorithms that control flow rate of insulin delivery);
wherein the one or more reservoirs, the fluid delivery mechanism, the sensing mechanism, and the controller are co-located in the housing (Smeys; integrated wearable pod 102 that includes a reservoir 104, pumping unit 106, microcontroller unit (MCU) 108, insulin delivery needle 110, glucose monitoring components 112 including a CGM, a sensor and needle (percutaneously inserted into the patient, and battery and power controller 114 as part of a single autonomous unit in figs. 1, 6, and 7; para [0025]).
Smeys fails, however, to disclose an amplifier for amplifying signals from the sensing mechanism;
a multiplexer for multiplexing the signals from the sensing mechanism;
an analog-to-digital converter for converting the analog signals from the sensing mechanism to digital signals.
Windmiller teaches an amplifier for amplifying signals from the sensing mechanism (Windmiller; para [0132], a differential amplifier, a transimpedance amplifier, or a finite gain amplifier may be incorporated);
a multiplexer for multiplexing the signals from the sensing mechanism (Windmiller; para [0104-0106], analog front end may include a multi-channel potentiostat to multiplex sensor input and handle multiple signal channels);
an analog-to-digital converter for converting the analog signals from the sensing mechanism to digital signals (Windmiller; fig. 2A; para [0040], electronic system 120 arranged in housing 112 includes various electronic components, such as sensor circuitry 124 configured to convert analog signals from the electrochemical sensors to digital signals).
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 of Smeys to include the amplifier, multiplexer, and analog-to-digital converter, as taught by Windmiller, in order to accurately acquire low-level electrochemical signals from the sensing mechanism, support multiple sensing channels, and enable existing controller to perform algorithmic analysis of digitized signals for improved closed-loop dosing.
Regarding claim 4, modified Smeys discloses the device of claim 1 that comprises a sensing mechanism (Smeys; glucose monitoring components 112 in fig. 1), but Smeys fails to disclose that the sensing mechanism uses one or more electrochemical cells.
Windmiller teaches a sensing mechanism that uses one or more electrochemical cells (Windmiller; electrochemical cell 1010 with working electrode 1110 and counter electrode 1120 in figs. 10-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the sensing mechanism of modified Smeys with one or more electrochemical cells, as taught by Windmiller, in order to provide reliable, miniaturizable, and low-power continuous analyte monitoring while also offering high sensitivity in interstitial fluid with relatively fast response times suitable for wearable insulin delivery systems.
Regarding claim 5, modified Smeys discloses the device of claim 4, but fails to disclose that the electrochemical cells are in the form of one or more microneedle arrays.
Windmiller teaches that the electrochemical cells are in the form of one or more microneedle arrays (Windmiller; para [0036], analyte monitoring device 110 may include a microneedle array comprising at least one electrochemical sensor; para [0047], microneedle array 300 for use in sensing one or more analytes may include one or more microneedles 310 in figs. 3A-3B; para [0042] microneedle array 140 is worn by user and extends into the skin of the user such that electrodes rest in the dermis).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the electrochemical cells of modified Smeys in the form of one or more microneedle arrays, as taught by Windmiller, in order to reduce insertion pain, minimize tissue trauma, improve user comfort and compliance, and enable shallow, localized sensing in the dermal or subdermal compartment while utilizing a compact platform that integrates well with electrochemical continuous glucose monitoring systems.
Regarding claim 6, modified Smeys discloses the device of claim 4, wherein the amplifier amplifies signals (Windmiller; para [0132], a differential amplifier, a transimpedance amplifier, or a finite gain amplifier may be incorporated) from the one or more electrochemical cells (Windmiller; electrochemical cell 1010 with working electrode 1110 and counter electrode 1120 in figs. 10-11);
the multiplexer multiplexes the signals (Windmiller; para [0106], analog front end may include a multi-channel potentiostat to multiplex sensor input and handle multiple signal channels) from the one or more electrochemical cells (Windmiller; electrochemical cell 1010 with working electrode 1110 and counter electrode 1120 in figs. 10-11); and
the analog-to-digital converter converts the analog signals from the one or more electrochemical cells to digital signals (Windmiller; fig. 2A; para [0040], electronic system 120 arranged in housing 112 includes various electronic components, such as sensor circuitry 124 configured to convert analog signals from the electrochemical sensors to digital signals);
wherein software executing on the controller analyzes the digital signals to determine the analyte level (Windmiller; microcontroller 122 in fig. 2A; para [0108], electronic system 120 may include microcontroller 122 which, itself, may also include a processor to execute a programmed routine in firmware to interpret the signals and perform any relevant analysis).
Claims 2-3 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Smeys in view of Windmiller, as applied to claim 1 above, and further in view of Yodfat (US Publication No. 2008/0214916), hereinafter, Yodfat.
Regarding claim 2, Smeys discloses the device of claim 1, the fluid delivery mechanism (Smeys; needle 110 that enters the body in fig. 1), but Smeys fails to disclose that the fluid delivery mechanism is a cannula subcutaneously inserted into the user.
Yodfat teaches a fluid delivery mechanism that is a cannula subcutaneously inserted into the user (Yodfat; first cannula 6 and second cannula 66 in fig. 4; para [0052], dispensing apparatus delivers insulin by one cannula 6 and senses glucose by a subcutaneously located sensing element provided at another cannula 66).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the fluid delivery mechanism of Smeys as a subcutaneously inserted cannula, as taught by Yodfat, in order to provide a standard, comfortable subcutaneous infusion set and to reduce user discomfort and complexity.
Regarding claim 3, Smeys discloses the device of claim 1, but fails to disclose the device of claim 1 further comprising: a cannula configured with a 2-electrode sensor comprising a working electrode and a combination counter/reference electrode.
Yodfat teaches the device of claim 1 further comprising: a cannula configured with a 2-electrode sensor comprising a working electrode and a combination counter/reference electrode (Yodfat; two or more electrodes 120 and 122; para [0055], electrodes can reside within a portion of the cannula 6 that protrudes beneath the skin 5 when the device is worn by a user; optionally a reference electrode can be used to determine a voltage associated with the electrochemical reaction occurring at the working electrode).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the fluid delivery mechanism of modified Smeys with an electrochemical sensing arrangement having either (i) a two-electrode sensor comprising a working electrode and a combination counter/reference electrode, or (ii) a three-electrode sensor comprising one or more working electrodes, a reference electrode, and a counter electrode, as taught by Yodfat, in order to allow the sensors to directly contact interstitial fluid in the same tissue compartment where insulin is delivered which enables more representative and timely glucose measurements.
Regarding claim 17, modified Smeys discloses the device of claim 2 wherein the cannula (Yodfat; first cannula 6 and second cannula 66 in fig. 4; para [0052], dispensing apparatus delivers insulin by one cannula 6 and senses glucose by a subcutaneously located sensing element provided at another cannula 66) is also used as the fluid delivery mechanism (Smeys; pumping unit or element 106 with its valves, actuators, sensors, pumping chamber, fluid channels shown in fig. 2A, and insulin needle 110 that enters the body in fig. 1).
Regarding claim 18, modified Smeys discloses the device of claim 2 that comprises a fluid delivery mechanism (Smeys; pumping unit or element 106 with its valves, actuators, sensors, pumping chamber, fluid channels shown in fig. 2A, and insulin needle 110 that enters the body in fig. 1), but Smeys fails to disclose that the fluid delivery system comprises a second cannula subcutaneously inserted into the user.
Yodfat teaches that the fluid delivery mechanism comprises a second cannula subcutaneously inserted into the user (Yodfat; first cannula 6 and second cannula 66 in fig. 4; para [0052], dispensing apparatus delivers insulin by one cannula 6 and senses glucose by a subcutaneously located sensing element provided at another cannula 66).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the fluid delivery mechanism of Smeys with a second subcutaneously inserted cannula as a fluid delivery mechanism, as taught by Yodfat, in order to provide optimal anatomical placement of each cannula for accurate measurement of glucose that does not interfere with analyte sensing, while still providing a comfortable user experience.
Conclusion
THIS ACTION IS MADE FINAL. 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 ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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