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
The amendment filed 11/13/25 is acknowledged. Claims 1-3, 7, 11-15, 26, 32-33, 38, 46, 57, 60, 71, 75, and 82-83 remain pending. No claims have been amended.
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.
Claims 1-3, 7,11-15, 26, 32,33, 38, 46, and 57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kendall et al. (WO2021062475A1; hereinafter known as “Kendall”). Regarding claim 1 and 32, Kendall teaches a microneedle array (See Kendall Figure 5) for use in sensing cortisol (See Kendall [0350], a small molecule from the group consisting of cortisol), comprising: a plurality of solid microneedles (See Kendall [0225] [0227] Figure 7B), wherein at least one microneedle of the plurality of solid microneedles comprises: a tapered distal portion having an insulated distal apex (See Kendall [0058] Figure 7B [0505], insulating layer 512.1); and an annular working electrode located on a surface of the tapered distal portion that is proximal to the insulated distal apex (See Kendall Figure 7B part 512.3), wherein the working electrode is configured to generate a sensor signal that is indicative of a concentration of cortisol in the dermal interstitial fluid when contacting the dermal interstitial fluid (See Kendall [0505], the electrical signal is communicated midway along the structure). Regarding claim 2, Kendall teaches wherein the working electrode comprises an electrode material (See Kendall Figure 7B part 512.3) and a biorecognition layer arranged at least partially over the electrode material, wherein the biorecognition layer comprises an aptamer that selectively and reversibly binds to cortisol (See Kendall [0019], aptamer coating the microstructure). Regarding claim 3, Kendall teaches wherein the aptamer is tethered directly or indirectly to the electrode material via a linker (See Kendall [0323], aptamer attached via linker ). Regarding claim 7 and 38, Kendall teaches the microneedle array of claim 2, wherein: the electrode material comprises gold (See Kendall [0341], gold coated electrodes), and the aptamer is tethered to the electrode material via a thiol link (See Kendall [0029] [0030]). Regarding claim 11, Kendall teaches that the biorecognition layer comprises a conductive polymer layer arranged at least partially over the electrode material (See Kendall [0047]); and the aptamer is tethered to the conductive polymer layer (See Kendall [0323], the aptamer comprises a moiety for attaching via linker such as a polymer; [0268], [0569]). Regarding claim 12, Kendall teaches that the aptamer is tethered to the conductive polymer layer via an amide linker (See Kendall [0267][00321-0323][0327-0329], the aptamer is attached via a polymer, which can be made from various materials, [0268], [0569]). Regarding claim 13, Kendall teaches the electrode material comprises a silicon; and the aptamer is tethered to the electrode material via a silane linker (See Kendall [0047][0269][0391], the microstructures include at least one of silicone) . Regarding claim 14, Kendall teaches the electrode material comprises carbon and the aptamer is tethered to the electrode material via an amide (See Kendall [0267][00321-0323][0327-0329], the aptamer is attached via a polymer, which can be made from various materials). Regarding claim 15 and 46, Kendall the aptamer is covalently bound to a redox-active molecule at the 3' end or the 5' end of the aptamer such that selective binding of the cortisol to the aptamer and a resulting conformational change of the aptamer changes the proximity between the redox-active molecule and a surface of the electrode material to modulate electron transfer between the redox-active molecule and the electrode material, thereby generating the sensor signal (See Kendall [0024-0025][0309][0314] also see [0328], the redox moiety may be attached at any suitable point on the aptamer provided that the conformational change ). Regarding claim 26 and 57, Kendall teaches the annular working electrode is an annular electrode comprises a proximal edge and a distal edge (See Kendall [0056]), and the distal edge of the annular working electrode is proximate a proximal edge of the insulated distal apex (See Kendall [0058] Figure 7B [0505], insulating layer 512.1).
Regarding claim 33, Kendall teaches the working electrode comprises an electrode material (See Kendall Figure 7B part 512.3) and a biorecognition layer arranged at least partially over the electrode material (See Kendall [0019], aptamer coating the microstructure), wherein the biorecognition layer comprises an aptamer that selectively and reversibly binds to cortisol (See Kendall [0020], the aptamer selectively binds [0350] [, the analyte may be cortisol).
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 60, 71, 75, 82 and 83 are rejected under 35 U.S.C. 103 as being unpatentable over Kendall in view of Utter et al. (US20150186609A1; hereinafter known as “Utter”). Regarding claim 60, Kendall teaches a cortisol monitoring device comprising: a wearable housing comprising a user interface (See Kendall [0429]); and the microneedle array of claim 1, extending outwardly from the wearable housing (See Kendall [0040][0103]). Kendall is silent to wherein the user interface comprises one or more indicator lights, each other one or more indicator lights configured to be selectively illuminated responsive to the signal.Utter teaches a wearable device to determine a user’s status and further teaches the user interface comprises one or more indicator lights, each other one or more indicator lights configured to be selectively illuminated responsive to the signal (See Utter [0096, device has a user interface with lights that determine user’s mood dependent on user’s mood). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Kendall with one or more indicator lights, each other one or more indicator lights configured to be selectively illuminated responsive to the signal as taught by Utter to inform user of their psychological state (See Utter [0100-0101]). Regarding claim 71, Kendall teaches the cortisol monitoring device is a skin adhered patch (See Kendall [0086], adhesive patch) Regarding claim 75, Kendall teaches determining a user status based on the signal (See Kendall [0429]). Kendall is silent to and selectively illuminating one or more indicator, lights based on the user status. Utter teaches selectively illuminating one or more indicator, lights based on the user status (See Utter [0096, device has a user interface with lights that determine user’s mood dependent on user’s mood). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Kendall with selectively illuminating one or more indicator, lights based on the user status as taught by Utter to inform user of their psychological state. Regarding claim 82, Kendall teaches the user status (See Kendall [0429]). Kendall is silent to is a psychological state of the user. Utter teach a psychological state of user (See Utter [0096, device has a user interface with lights that determine user’s mood dependent on user’s mood). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Kendall a psychological state of user as taught by Utter to inform user of their psychological state (See Utter [0100-0101]).
Regarding claim 83, Kendall is silent to the psychological state is a degree of stress of the user. Utter teach a psychological state is a degree of stress of the user (See Utter [0096][0100-0101], device has a user interface with lights that determine user’s mood dependent on user’s mood). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Kendall the psychological state is a degree of stress of the user. Utter teach a psychological state is a degree of stress of the user as taught by Utter to further monitor the psychological state of user (See Utter [0100-0101]).
Response to Arguments
Applicant’s arguments have been fully considered. Applicant argues that Kendall fails to teach annular electrodes and further fails to teach electrodes on the tapered surface. Examiner disagrees. Paragraphs 0502-0507 clearly note that electrodes can be annular and any other configuration. Further, paragraph 0505 notes that there can be ports within the insulating layer – which imply the electrode to be on the tapered portion. The rejection is maintained.
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 JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
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