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 amendment filed on March 9, 2026.
Claims 7-16 and 19-20 are withdrawn.
Claims 17-18 are amended.
Claims 1-6 and 17-18 are currently under examination.
Election/Restrictions
Applicant’s election without traverse of claims 1-6 and 17-18 (corresponding to Species 1A (cannula-based fluid delivery) and Species 2A (electrochemical sensing) in the reply filed on March 9, 2026 is acknowledged.
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 (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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smeys (US Publication No. 2022/0409051, hereinafter, Smeys).
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 tracks patient glucose levels); and
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).
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.
Claims 2-3 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Smeys 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 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.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Smeys in view of Windmiller (US Publication No. 20220370011, hereinafter, Windmiller).
Regarding claim 4, 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 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; 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).
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 claim 4 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, but fails to disclose the device of claim 4 further comprising: an amplifier for amplifying signals from the one or more electrochemical cells;
a multiplexer for multiplexing the signals from the one or more electrochemical cells; and
an analog-to-digital converter for converting the analog signals from the one or more electrochemical cells to digital signals;
wherein software executing on the controller analyzes the digital signals to determine the analyte level.
Windmiller teaches the device of claim 4 further comprising: an amplifier for amplifying 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);
a multiplexer for multiplexing 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
an analog-to-digital converter for converting 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).
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 electrochemical sensing mechanism of modified Smeys with an amplifier, a multiplexer, and an analog-to-digital converter, and to have software on the controller analyze the resulting digital signals, as taught by Windmiller, in order to accurately acquire low-level electrochemical signals from the microneedle-based cells, support multiple sensing channels, and enable the existing controller to perform algorithmic analysis of digitized signals for closed-loop dosing.
Conclusion
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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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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