DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. According to the Amendment, filed 05 June 2026, the status of the claims is as follows:
Claims 27, 30, and 39 are currently amended;
Claims 31, 33, 41, 42, 48 are previously presented;
Claims 28, 29, 32, 34-38, 40, and 43-47 are as originally filed; and
Claims 1-26 are cancelled.
Response to Arguments
3. Applicant’s arguments, see Remarks, p. 7, filed 05 June 2026, with respect to the rejection of claims 27-40 and 43-48 under 35 U.S.C. 102(a)(1) as being anticipated by Pushpala et al., U.S. Patent Application Publication No. 2021/0321942 A1, have been fully considered, and are persuasive in view of the Amendment, filed 05 June 2026. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection, which was necessitated by amendment, is discussed below.
Claim Rejections - 35 USC § 102
4. 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.
5. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
6. Claims 27-40 and 43-48 are rejected under 35 U.S.C. 103 as being unpatentable over Pushpala et al., U.S. Patent Application Publication No. 2021/0321942 A1 (“Pushpala”), in view of Jiang et al., C.N. 110974251 A (“Jiang”).
As to Claim 27, Pushpala teaches the following:
A system for measurement of an analyte level (see “Systems, devices, and methods for biomonitoring are disclosed herein.” in Abstract), comprising:
a flexible sensor control device (“pod”) 204 … and configured to house one or more sensor electronics (“electronics assembly”) 212 (see “The pod 204 can be a capsule, module, or other durable structure that couples to the patch 202 in order to assemble the device 200. The pod 204 can be mechanically coupled to the patch 202 using any suitable temporary or permanent attachment method, such as interference fit, snap fit, threading, fasteners, bonding, adhesives, and/or suitable combinations thereof. The pod 204 can include a casing or housing that encloses an electronics assembly 212 (also referred to herein as an “electronics subsystem”) of the device 200. The electronics assembly 212 can include one or more electronic components configured to perform the various operations described herein, such as a processor 214, memory 216, power source 218, and communication unit 220.” in para. [0062]);
an array of analyte sensors (“microneedles”) 208 disposed along a distal-facing surface of the sensor control device 204 (see “The patch 202 can include a substrate 206 configured to couple to the user's body (e.g., to the surface of the skin) via adhesives or other suitable temporary attachment techniques. The base portion also includes at least one array of microneedles 208 coupled to and/or supported by the substrate 206.” in para. [0059]), … and wherein each analyte sensor (“microneedle”) 700a in the array of analyte sensors 208 (see “Referring first to FIG. 7A, the microneedle 700a includes a substrate 702 having a base 704, and a needle body 706 extending from the base 704.” in para. [0143], and see fig. 7A) comprises a distal portion (“needle body”) 706 configured to be positioned under a skin surface of a user (see “The needle body 706 can terminate in a tip 708 configured to penetrate into the skin.” in para. [0144]); and
an applicator (“applicator”) 400 configured to apply the sensor control device onto the skin surface of the user (see “Referring first to FIGS. 4A (top perspective view of the applicator 400), 4B (bottom perspective view), and 4C (cross-sectional view) together, the applicator 400 can be manually operated by a user to apply a biosensor device (e.g., the device 300 of FIGS. 3A-3R) to the user's skin.” in para. [0116]), wherein the applicator comprises a dispenser (“actuation mechanism”) 404 (see “Referring next to FIG. 4C, the upper and lower housings 402a-b can collectively enclose an actuation mechanism 404 for loading a biosensor and applying the biosensor to the user's skin (also referred to herein as “firing” the biosensor).” in para. [0117]).
Pushapala does not teach the following:
a flexible sensor control device comprising one or more flexible portions …
wherein at least one analyte sensor of the array of analyte sensors is disposed along a flexible portion of the one or more flexible portions, …
However, Jiang teaches the following:
a flexible sensor control device (“pressing micro-needle sensor piece”, not labeled, includes “sensor element 1” and “hardware interface circuit 2”) (see “As shown in FIG. 1, needle type electrochemical sensor based on mobile phone platform comprises a pressing micro-needle sensor piece has reverse iontophoresis function and three-electrode electrochemical detection function 1 and a mobile phone hardware interface circuit for Bluetooth data exchange 2, the hardware interface circuit 2 and the sensor element 1 is connected, a hardware interface circuit 2 comprises a microcontroller 21, electro-osmosis module 22, detection module 23, and power source 24.” in para. [0018]) comprising one or more flexible portions (“flexible circuit board”, not labeled, including “elastomer 12”, “hydrogel 13”, and “hydrogel 14”) 12/13/15 (see “the specific structure of the pressure micro-needle sensor component 1 shown in FIG. 2, comprising a micro-needle array 11, elastomer 12, hydrogel 13. The flexible circuit board containing biological recognition molecule 14, the hydrogel 14 surrounding periphery of anti-seepage ring 15 …” in para. [0019]);
wherein at least one analyte sensor (“micro-needle sensor”, not labeled) of an array of analyte sensors (“micro-needle array”) 11 is disposed along a flexible portion (“hydrogel”) 14 of the one or more flexible portions 12/13/14 (see “the specific structure of the pressure micro-needle sensor component 1 shown in FIG. 2, comprising a micro-needle array 11, elastomer 12, hydrogel 13. The flexible circuit board containing biological recognition molecule 14, the hydrogel 14 surrounding periphery of anti-seepage ring 15 …” in para. [0019], and see fig. 2).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Pushpala’s flexible sensor control device (“pod 204”) to include Jiang’s flexible portion (“hydrogel 14”), wherein Pushpala’s array of analyte sensors (“microneedles 208”) is disposed along Jiang’s flexible portion (“hydrogel 14”) in order to the following advantage (see Jiang, para. [0014]):
puncturing the skin micro-needle array leaving a micro-channel, which can improve the efficiency of biomolecule reverse iontophoresis, so as to improve the sensitivity of detection. biorecognition molecules modified at the surface of the micro-needle array, in the puncture process to large acreage fallen off because of the action of the friction force, and the biomolecule to extract by reverse electro-osmosis hydrogel containing a bio-recognition molecules can avoid such a situation.
As to Claim 28, Pushpala teaches the following:
wherein the sensor control device 204 is partially or entirely flexible, and wherein the sensor control device 204 is configured to contour to a body of the user (see “Additionally, the mounting substrate 310 itself can be a flexible component configured to conform the user's body to further improve adhesion and user comfort.” in para. [0082]).
As to Claim 29, Pushpala teaches the following:
wherein the sensor control device 204 comprises a structurally rigid portion (“upper pod housing 352a” and “lower pod housing 352b”) 352a-b (see “The pod 304 can include an upper pod housing 352a (“upper housing 352a”) and a lower pod housing 352b (“lower housing 352b”) that connect to each other to enclose and protect the electronics assembly 350. The upper and lower housings 352a-b can each be made of a durable, rigid, and/or watertight material (e.g., plastic), which can be advantageous for limiting fluid ingress into the pod 304, prolonging the usable lifespan of the pod 304, avoiding inadvertent damage during use, and/or facilitating cleaning.” in para. [0090], and see fig. 3J), a first flexible portion (“first leaflet”) 398a (see “Although FIG. 3R depicts the sealing element 396 as having multiple sections or leaflets, (e.g., first and second leaflets 398a-b), …” in para. [0111], and fig. 3R), and a second flexible portion (“second leaflet”) 398b (see “Additionally, the mounting substrate 310 itself can be a flexible component configured to conform the user's body to further improve adhesion and user comfort.” in para. [0082]), and wherein the structurally rigid portion 352a-b houses the one or more sensor electronics 212 (see “For example, as best seen in FIG. 3J, the lower housing 352b can include a plurality of stakes or posts 353 so that the upper housing 352a, lower housing 352b, and electronics assembly 350 can be permanently affixed to each other by heat staking.” in para. [0090, and see fig. 3J]).
As to Claim 30, Pushpala teaches the following:
wherein the sensor control device 204 further comprises a structurally rigid portion (“upper pod housing 352a” and “lower pod housing 352b”) 352a-b (see “The pod 304 can include an upper pod housing 352a (“upper housing 352a”) and a lower pod housing 352b (“lower housing 352b”) that connect to each other to enclose and protect the electronics assembly 350. The upper and lower housings 352a-b can each be made of a durable, rigid, and/or watertight material (e.g., plastic), which can be advantageous for limiting fluid ingress into the pod 304, prolonging the usable lifespan of the pod 304, avoiding inadvertent damage during use, and/or facilitating cleaning.” in para. [0090], and see fig. 3J), wherein the one or more sensor electronics 212 are housed within the structurally rigid portion 352a-b and the one or more flexible portions (see “For example, as best seen in FIG. 3J, the lower housing 352b can include a plurality of stakes or posts 353 so that the upper housing 352a, lower housing 352b, and electronics assembly 350 can be permanently affixed to each other by heat staking.” in para. [0090, and see fig. 3J]).
As to Claim 31, Pushpala teaches the following:
wherein the distal portion 706 of each analyte sensor 700a in the array of analyte sensors 208 is a shortened sensor tail distal portion (“needle body”) 706 comprising a sharpened tip portion (“tip”) 708, wherein the shortened distal portion is between 0.8 millimeters and three millimeters in length (see “The needle body 706 can have any suitable cross-sectional shape or profile, such as square, rectangular, triangular, circular, oval, polygonal, non-polygonal, etc. The needle body 706 can terminate in a tip 708 configured to penetrate into the skin. As shown in FIG. 7A, the tip 708 can be a sharpened structure having a multi-faceted (e.g., pyramidal) or other suitable shape. The needle body 706 and tip 708 can collectively have a length less than or equal to 500 μm, 475 μm, 450 μm, 425 μm, 400 μm, 350 μm, 300 μm, 250 μm, 200 μm, 150 μm, 100 μm or 50 μm (or any other suitable length).” in para. [0144]).
As to Claim 32, Pushpala teaches the following:
an adhesive (“substrate”) 206 positioned on an underside of the sensor control device 204, wherein the adhesive 206 is configured to secure and maintain the sensor control device 204 in position on the user's skin surface (see “The patch 202 can include a substrate 206 configured to couple to the user's body (e.g., to the surface of the skin) via adhesives or other suitable temporary attachment techniques.” in para. [0059]).
As to Claim 33, Pushpala teaches the following:
an adhesive (“adhesive region”) 318, wherein the adhesive 318 comprises a plurality of openings configured to absorb moisture and liquid released from the sensor control device 204 (see “The adhesive region 318 can be made of any suitable material suitable for coupling to the skin for an extended time period (e.g., at least 12 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, etc.). The material of the adhesive region 318 can also be biocompatible, breathable, and/or water-resistant, e.g., to reduce discomfort and/or avoid premature detachment.” in para. [0082]).
As to Claim 34, Pushpala teaches the following:
a superabsorbent layer (“adhesive region”) 318 configured to absorb moisture and liquid absorbed by the plurality of openings (see “The adhesive region 318 can be made of any suitable material suitable for coupling to the skin for an extended time period (e.g., at least 12 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, etc.). The material of the adhesive region 318 can also be biocompatible, breathable, and/or water-resistant, e.g., to reduce discomfort and/or avoid premature detachment.” in para. [0082]).
As to Claim 35, Pushpala teaches the following:
a backing layer (“sealing element”) 396 configured on a top exterior surface of the sensor control device 204, wherein the backing layer 396 is further configured to inhibit the superabsorbent layer 318 from absorbing moisture and liquid from an external environment (see “Before use, the sealing element 396 and cover 397 can be temporarily attached to the patch 302 to protect the device components at the lower surface of the patch 302. For example, the sealing element 396 can be a film, sheet, tape, etc., that partially or fully covers the adhesive region 318 (obscured in FIGS. 3Q and 3R). ” in para. [0111]).
As to Claim 36, Pushpala teaches the following:
wherein the one or more sensor electronics 212 comprises one or more printed batteries (“power source”) 218, wherein each of the one or more printed batteries 218 are configured to be flexible (see “The power source 218 can be any component suitable for powering the operations of the device 200, such as a rechargeable battery, non-rechargeable battery, or suitable combinations thereof. The power source 218 can output power to the array of microneedles 208, processor 214, memory 216, communication unit 220, sensor(s) 222, and/or any other electronic components on the patch 202 or pod 204.” in para. [0065]).
As to Claim 37, Pushpala teaches the following:
wherein the one or more sensor electronics 218 comprises a stack of multiple layers of printed batteries (see para. [0065]).
As to Claim 38, Pushpala teaches the following:
wherein the sensor control device 204 comprises a structurally rigid portion (“upper pod housing 352a” and “lower pod housing 352b”) 352a-b (see “The pod 304 can include an upper pod housing 352a (“upper housing 352a”) and a lower pod housing 352b (“lower housing 352b”) that connect to each other to enclose and protect the electronics assembly 350. The upper and lower housings 352a-b can each be made of a durable, rigid, and/or watertight material (e.g., plastic), which can be advantageous for limiting fluid ingress into the pod 304, prolonging the usable lifespan of the pod 304, avoiding inadvertent damage during use, and/or facilitating cleaning.” in para. [0090], and see fig. 3J), a first flexible portion (“first leaflet”) 398a (see “Although FIG. 3R depicts the sealing element 396 as having multiple sections or leaflets, (e.g., first and second leaflets 398a-b), …” in para. [0111], and fig. 3R), and a second flexible portion (“second leaflet”) 398b (see “Additionally, the mounting substrate 310 itself can be a flexible component configured to conform the user's body to further improve adhesion and user comfort.” in para. [0082]), wherein the structurally rigid portion 352a-b is disposed between the first flexible portion 398a and the second flexible portion 398b (see fig. 3R).
As to Claim 39, Pushpala teaches the following:
wherein the sensor control device 204 comprises a structurally rigid portion (“upper pod housing 352a” and “lower pod housing 352b”) 352a-b (see “The pod 304 can include an upper pod housing 352a (“upper housing 352a”) and a lower pod housing 352b (“lower housing 352b”) that connect to each other to enclose and protect the electronics assembly 350. The upper and lower housings 352a-b can each be made of a durable, rigid, and/or watertight material (e.g., plastic), which can be advantageous for limiting fluid ingress into the pod 304, prolonging the usable lifespan of the pod 304, avoiding inadvertent damage during use, and/or facilitating cleaning.” in para. [0090], and see fig. 3J), wherein the structurally rigid portion 352a-b comprises a thickness that is greater than a thickness of the one or more flexible portions (see fig. 3R).
As to Claim 40, Pushpala teaches the following:
wherein the sensor control device 212 is a flexible strip with rounded edges (see “electronics assembly 350” in fig. 3J).
As to Claim 43, Pushpala teaches the following:
wherein the applicator 400 comprises a handle (“hammer”) 408 and a dispenser receiving portion (“set of latches”) 410 configured to receive the dispenser 404 (see “In the illustrated embodiment, for example, the actuation mechanism 404 includes: a suction element 406 for temporarily coupling to the biosensor; a hammer 408 carrying the suction element 406 and movable between resting, loaded, and firing configurations; a set of latches 410 for temporarily securing the hammer 408 in the loaded configuration, a trigger 412 for releasing the hammer 408 from the loaded configuration, and a spring 414 for firing the hammer 408 and suction element 406 towards the user's skin.” in para. [0117], and fig. 4C).
As to Claim 44, Pushpala teaches the following:
wherein the dispenser 404 is configured to hold one or more sensor control devices 204 (see figs. 4C and 5F).
As to Claim 45, Pushpala teaches the following:
wherein the dispenser 404 comprises a shell (“upper housing”) 402a (see “The upper housing 402a can be a rounded, dome-like shell or structure having an interior cavity.” in para. [0116]) and an inner ring (“lower housing”) 402b, wherein the sensor control device 204 is arranged along the inner ring (see “The lower housing 402b can be a hollow, barrel- or tube-like structure that fits at least partially within the upper housing 402a.” in para. [0116]).
As to Claim 46, Pushpala teaches the following:
wherein the dispenser 404 can store one or more sensor control devices 204 (see figs. 4C and 5F), wherein the dispenser 404 comprises a shell (“upper housing”) 402a (see “The upper housing 402a can be a rounded, dome-like shell or structure having an interior cavity.” in para. [0116]) and an inner ring (“lower housing”) 402b, wherein the shell 402a is configured to partially enclose the inner ring 402b (see “The lower housing 402b can be a hollow, barrel- or tube-like structure that fits at least partially within the upper housing 402a.” in para. [0116]), and wherein the shell 402a can form a protective cover for the stored one or more sensor control devices 204 (see para. [0116]).
As to Claim 47, Pushpala teaches the following:
wherein the applicator 400 is configured to provide an audible or tactile feedback to indicate that the sensor control device has been successfully applied to the user's skin surface (see “The station 600 can include at least one indicator configured to output signals representing the operational status of the pod 304. For example, the station 600 can include one or more light sources (e.g., LEDS—not shown) that may convey status information to the user by turning on or off, displaying different colors, flashing or blinking, etc.” in para. [0138]).
As to Claim 48, Pushpala teaches the following:
wherein each analyte sensor 700a in the array of analyte sensors 208 comprises a distal portion 706 extending distally from the underside of the sensor control device 204 (see figs. 2 and 7A).
7. Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Pushpala in view of Jiang, as applied to claim 27 above, and further in view of Headen et al., U.S. Patent Application Publication No. 2024/0090802 A1 (“Headen”).
As to Claim 41, Pushpala in view of Jiang teaches the subject matter of claim 27 above. Pushpala in view of Jiang does not teach the following:
wherein the sensor tail distal portion of each of the plurality analyte sensor in the array of analyte sensors is coated with dexamethasone, wherein the dexamethasone is configured to inhibit signal loss and utilizes a control release mechanism.
However, Headen teaches the following:
a sensor tail distal portion of each of the plurality analyte sensor in the array of analyte sensors is coated with dexamethasone, wherein the dexamethasone is configured to inhibit signal loss and utilizes a control release mechanism (see “Accordingly, a sensor as discussed in examples herein may include a drug releasing membrane at least partially functioning as or in combination with a biointerface membrane. The drug releasing membrane may include, for example, materials including a hard-soft segment polymer with hydrophilic and optionally hydrophobic domains, all of which are described in more detail elsewhere herein, can be employed to improve sensor function in the long term (e.g., after tissue ingrowth). In one example, the materials including a hard-soft segment polymer with hydrophilic and optionally hydrophobic domains are configured to release a combination of a derivative form of dexamethasone or dexamethasone acetate with dexamethasone such that one or more different rates of release of the anti-inflammatory is achieved and the useful life of the sensor is extended.” in para. [0205]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Pushpala’s sensor tail distal portion (“needle body”) 706 to be coated with dexamethasone, as taught by Headen, because “… one or more different rates of release of the anti-inflammatory is achieved and the useful life of the sensor is extended”. Furthermore, Headen is analogous art to Pushpala as both teachings are directed to continuous analyte sensor devices (see Headen, para. [0002]; and see Pushpala, Abstract).
Allowable Subject Matter
8. Claim 42 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
9. The following is a statement of reasons for the indication of allowable subject matter:
As to Claim 42, neither Pushpala, Jiang, Headen nor the prior art of record teaches the system of base claim 27, including the following, in combination with all other limitations of the base claim:
wherein the sensor tail distal portion of each of the plurality analyte sensor in the array of analyte sensors comprises an enteric coating configured to dissolve after insertion of the sensor tail.
Conclusion
10. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 08/31/2026
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