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 .
Claims Accounting
Applicant' s arguments, filed 02/26/2026, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 02/26/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-2, 4-9, 11, 13, and 23-24 have been amended.
Claims 10 and 12 have been canceled.
Claims 1-9, 11, 13, and 23-25 are the current claims hereby under examination.
Information Disclosure Statements
The information disclosure statements (IDS) submitted on 3/31/2026 have been considered by the examiner.
Foreign patent document #5 (AU 2012326664) of an IDS filed on 3/31/2026 was not considered as the corresponding document was not provided.
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 5-6 and 8 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 claims 5-6, claims 5 and 6 recite the phrase “the working electrode” in lines 3 and 3, respectively. Claim 1 recites “wherein at least one of the micropillar electrodes of the array further comprises at least one sensing layer… and is configured as a working electrode”. Therefore, claim 1 includes at least one working electrode. Therefore, it is unclear which of the at least one working, “the working electrode” refers to. Clarification is requested.
For the purposes of examination, the recitations of “the working electrode” are interpreted as “the at least one working electrode”.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
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 1, 3, 4, 7, 11, 13, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2014/0336487 by Wang et al. – previously cited, hereinafter “Wang” in view of Non Patent Literature Conducting Polymer 3D Microelectrodes (2010) by Sasso et al., hereinafter “Sasso”, in view of US Patent Publication 2008/0161654 by Teller et al., hereinafter “Teller”, as evidenced by US Patent Publication 2008/0288026 by Cross et al. – previously cited, hereinafter “Cross”.
Regarding claim 1, Fig. 1 of Wang teaches a wearable medical device for simultaneous and continuous monitoring of target analytes ([0009]; an adhesive patch for placement on skin to detect the analyte residing in transdermal fluid; [0065-0066], Abstract; the device comprises a microneedle array 100 with individually addressable probes 102 for sensing, and so is capable of simultaneous and continuous monitoring of a plurality of analytes), comprising: a microneedle array sensor unit (Fig. 1A-D; [0065-0066]; microneedle array 100 includes an array of hollowed microscale-sized needles 101 with sensing probes 102)), comprising: an array of microneedles (microneedle array 100), each comprising an exterior wall forming a protruding needle structure converging at an apex point (Figs. 1A-D show the three exterior walls of the needle structure coming to an apex point), wherein each microneedle includes a hollow interior defined by an interior wall, and an opening disposed on the exterior wall leading to the hollow interior (Figs. 1A-D, [0065]; “each needle 101 comprises a protruded needle structure having an exterior wall forming a hollow interior and an opening at the terminal end of the protruded needle structure to expose the hollow interior”) and the apex point configured to penetrate skin of a user to access a bodily fluid containing the target analytes ([0063]; the microneedles can be included in a patch that can be applied to penetrate the skin so that extracellular fluid can diffuse into the microneedle), and an array of micropillar electrodes (Fig. 1A; array of probes 102 comprising sensing electrodes, wherein the array of probes 102 is shown comprising pillars located within the microneedles 101, and thus comprise micropillars), each disposed within the hollow interior of a respective protruding needle structure (Fig. 1A; probes 102 are disposed within the hollow interior); an electronics unit in electrical communication with the array of micropillar electrodes (Fig. 1C, [0066, 0073]; each wire of the array of wires 103 is electrically conductive to transmit the probe sensing signal produced by a respective probe to a sensor circuit, in which the probe sensing signals are processed; a processing unit 175 to process the sensed analyte information), the electronics unit comprising a power source ([0073]; the processing unit 175 comprises a power supply), a signal processing circuit ([0073]; “a processing unit 175 to process the sensed analyte information as data”; the processing unit also comprises a processor and memory), and a wireless transmitter ([0073]; “The processing unit 175 can include an input/output (I/O) unit, coupled to the processor and memory, which can also be connected to an external interface, source of data storage, or display device. Various types of wired or wireless interfaces compatible with typical data communication standards”); a housing structure to encase the electronics unit (Fig. 1A-B and F show the housing encasing the electronics) and to encase, at least partially, the microneedle array sensor unit, such that at least the apex point and the opening of each microneedle of the array of microneedles protrude outward of the housing structure, wherein the array of microneedles is exposed from a side of the housing structure (Figs. 1A-B and 1F show the apex of the microneedles protruding and exposed from the side view of the housing structure).
Fig. 1 of Wang does not teach wherein at least one of the micropillar electrodes of the array is configured to interact with a first analyte further comprises at least one sensing layer comprising a biological or chemical substance on top of the conductive material and is configured as a working electrode to interact with the target analytes in the bodily fluid to produce an electrical signal indicative of an electrochemical reaction involving the target analytes.
Fig. 1J of Wang teaches that unique analytes can be detected at each microneedle within the sensing array by using ion-selective membranes with electrochemical measurements to impart selectivity towards the ions of interest ([0071]). Therefore, a different ion-selective membranes (i.e., biological or chemical substance configured to facilitate the electrochemical reaction with analytes) can be employed at each working electrode to enable the simultaneous monitoring of several unique analytes, which can miniaturize and integrate multiple laboratory-based tests into a single arrayed microneedle sensing platform ([0068]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of Fig. 1 of Wang such that at least one of the micropillar electrodes of the array is configured to interact with a first analyte further comprising at least one sensing layer comprising a biological or chemical substance on top of the conductive material and is configured as a working electrode to interact with the target analytes in the bodily fluid to produce an electrical signal indicative of an electrochemical reaction involving the target analytes, to miniaturize and integrate multiple laboratory-based tests into a single arrayed microneedle sensing platform, as taught by Wang ([0068]). It is noted that Wang teaches that probe 102 interacts with one or more chemical or biological substances that come in contact with the probe 102 via the opening to produce a probe signal (e.g., such as a sensing signal) ([0065-0066]), thereby generating an electrical signal indicative of an electrochemical reaction involving the target analytes.
Modified Wang does not teach the micropillar electrodes comprising a nonconductive material coated with a conductive material.
Sasso teaches a method of fabricating individually addressable conducting polymer pillar microelectrodes (Introduction, Abstract). This method, shown in Fig. 3, uses a silicon base covered with a nonconductive material (silicon nitride is an insulating material, see Page 10991, par. 1) coated with a conductive material (conductive polymer) by using a chemical oxidative reaction. This method of making micropillar electrodes provides the advantage of not requiring a metal layer or any surface catalyst to be present in areas covered by the polymer (Fabrication, Pg. 10991, par. 3). Using a conductive polymer film also has the advantage of the creation of a less polarizable surface compared to metal conductors (Introduction, Pg. 10988, par. 1).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of modified Wang such that the micropillar electrodes comprised a nonconductive material coated with a conductive material, in order to create a less polarizable surface compared to metal conductors, as taught by Sasso (Introduction, Pg. 10988, par. 1).
Wang in view of Sasso does not teach a plurality of surface-mount, spring-loaded pins that electrically couple the micropillar electrodes of the array to the signal processing circuit of the electronics unit.
Fig. 26 of Teller teaches a two-sided printed circuit board (860) with processing circuitry (processing unit 960) disposed on one side and surface mounted pogo contacts (i.e., spring-loaded pins) (32) on the other side that electrically couple to form an electrical connection with electrodes 825 ([0160]). The pogo contacts electrically couple the electrodes to a processing unit ([0164]). Cross teaches that spring-loaded pins have the advantage of providing a low impedance connection between electronics units and electrodes (Cross; [0050]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of Wang in view of Sasso to include a two-sided circuit board with a plurality of surface-mount, spring-loaded pins that electrically couple the micropillar electrodes of the array to the signal processing circuit of the electronics unit, as taught by Teller ([0160]). The spring-loaded pins have the advantage of providing a low impedance connection between electronics units and electrodes (Cross; [0050]).
It is noted that in the combination of Wang, Sasso, and Teller, the printed circuit board would house the electronics unit on a side opposite the spring-loaded pins, a configuration shown by Teller in Fig. 26. Additionally, the spring-loaded pins would contact and establish electrical connection with the electrical contacts of each electrode.
Regarding claim 3, the combination of Wang, Sasso, and Teller teaches the device of claim 1, wherein the protruding needle structure of at least some of the microneedles of the array includes one or more of (i) one exterior wall such that the protruding needle structure is of a conical shape, (ii) three exterior walls such that the protruding needle structure is of a triangular pyramid shape (Wang, Figs. 1A-D; protruding needle structure shape is a triangular pyramid shape), or (iv) four exterior walls such that the protruding needle structure is of a rectangular pyramid shape.
Regarding claim 4, the combination of Wang, Sasso, and Teller teaches the device of claim 1, wherein at least two of the micropillar electrodes is configured as one of the working electrodes and each comprises at least one of the sensing layers configured for a different one of the target analytes (See the rejection of claim 1, different ion-selective membranes are disposed on multiple electrodes to define working electrodes sensitive to different analytes, which would comprise at least two working electrodes to define electrodes sensitive to different analytes).
Regarding claim 7, the combination of Wang, Sasso, and Teller teaches the device of claim 1, but does not teach wherein the microneedles of the array of microneedles have a height ranging from 400µm-800µm.
It is noted that Applicant has failed to provide details of criticality or unexpected results in their specification with regard to the particularly claimed height of the array of microneedles. As such, it would have been obvious to one of ordinary skill in the art, through routine optimization, to have determined the optimal height of the array of microneedles. Furthermore, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 11, the combination of Wang, Sasso, and Teller teaches the device of claim 1, wherein the target analytes are selected from a group consisting of glucose, lactate, or alcohol (Wang, [0015]; “the disclosed technology can simultaneously and locally detect glucose, lactate, and pH”).
Regarding claim 13, the combination of Wang, Sasso, and Teller teaches the device of claim 1, wherein the device is configured to be a patch worn on the skin of the user (Wang, [0007]; the device can be integrated into an adhesive patch for placement on skin to detect the analyte residing in transdermal fluid).
Regarding claim 23, the combination of Wang, Sasso, and Teller teaches the device according to claim 1, which teaches all of the claimed features of claim 23, including:
an array of micropillar electrodes (Fig. 1A.; array of probes 102 comprising sensing electrodes, wherein the array of probes 102 is shown comprising pillars located within the microneedles 101, and thus comprise micropillars) comprising a nonconductive material coated with a conductive material (See the rejection of claim 1) each disposed within the hollow interior of a respective protruding needle structure (Fig. 1A; probes 102 are disposed within the hollow interior), wherein the micropillar electrodes of the array are configured to interact with an analyte that comes in contact with a sensing region of a respective micropillar electrode to produce an electrical signal indicative of an electrochemical reaction involving the analyte at the sensing region ([0065-0066]; probe 102 interacts with one or more chemical or biological substances that come in contact with the probe 102 via the opening to produce a probe signal (e.g., such as a sensing signal). The probes are configured to produce probe signals from the individually addressable microneedle sensing electrodes, therefore the regions around each microneedle sensing electrode produces a signal indicative of an electrochemical reaction involving the analyte at the sensing region).
Regarding claim 24, the combination of Wang, Sasso, and Teller teaches the device of claim 23, wherein the electronics unit includes a two-sided printed circuit board (PCB) configured to integrate electronic components including at least the signal processing circuit, the wireless transmitter, and the power source (see the rejection of claim 1 above, the components of the electronics unit are housed on one side of the two-sided PCB), wherein one side of the two-sided PCB includes the plurality of surface-mount, spring-loaded pins that electrically couple the micropillar electrodes to the signal processing circuit and/or the power source (See the rejection of claim 1 above).
Claims 2 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Sasso in view of Teller, as applied to claims 1 and 24, further in view of US Patent Publication 2016/0324442 by Zdeblick – previously cited, hereinafter “Zdeblick”.
Regarding claim 2, the combination of Wang, Sasso, and Teller teaches the device of claim 1, wherein the electronics unit includes a two-sided printed circuit board (PCB) configured to integrate electronic components including at least the signal processing circuit, the wireless transmitter, and the power source (see the rejection of claim 1 above, the components of the electronics unit are housed on one side of the two-sided PCB), wherein one side of the two-sided PCB includes the plurality of surface-mount, spring-loaded pins that electrically couple the micropillar electrodes to the signal processing circuit and/or the power source (See the rejection of claim 1 above).
The combination of Wang, Sasso, and Teller does not teach that at least one of the surface-mount, spring-loaded pins is configured to create an automatic power switch of the wearable medical device, the automatic power switch providing an electrical conduction path through the array of microneedles.
Fig. 34 of Zdeblick teaches a skin-wearable device that allows for power to be switched on in the device when contact is made by surface-mount, pogo pins connecting the circuity to the power source. Zdeblick also teaches connecting the electrodes to the circuitry through surface-mount pogo pins ([0235-0236]). When the pogo pins are not contacting the battery, no power can be supplied to the circuitry, therefore, the pogo pins define an automatic power switch.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of the combination of Wang, Sasso, and Teller to include surface-mounted, spring-loaded pins such that at least one of the surface-mount, spring-loaded pins is configured to create an automatic power switch of the wearable medical device the automatic power switch providing an electrical conduction path through the array of microneedles, as taught by Zdeblick ([0235-0236]). This combination of Wang in view of Teller and Zdeblick comprises combining prior art elements according to known methods to yield predictable results. See MPEP 2143-I-A.
It is noted that in the combination of Wang, Sasso, Teller, and Zdeblick, additional pogo pins are provided to establish electrical connection between the battery and the circuit, which in turn provides power through the circuit and the electrodes.
Regarding claim 25, the combination of Wang, Sasso, Teller, and Zdeblick teaches the device of claim 24 (see the rejection of claim 24 above), wherein the device includes an automatic power switch comprising at least one of the surface-mount, spring-loaded pins, wherein the automatic power switch providing an electrical conduction path through the array of microneedles (See the rejection of claim 2).
Claims 5-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Sasso in view of Teller, as applied to claim 4, further in view of US Patent Publication 2017/0055835 by Scherer et al. – previously cited, hereinafter “Scherer”.
Regarding claims 5 and 6, the combination of Wang, Sasso, and Teller teaches the device of claim 4, but does not teach wherein one of the micropillar electrodes is configured as a counter electrode relative to the working electrode and another of the micropillar electrodes is configured as a reference electrode relative to the working electrode.
Scherer teaches a minimally invasive sensing system using micrometer or nanometer sized needles (Abstract) that allows for the detection of multiple components in of the surrounding environment of the electrodes ([0039]). The sensing systems can have multiple working electrodes (i.e., first and second electrode probe structure) which can share same counter electrodes (i.e., third electrode probe structure) and reference electrodes (i.e., fourth electrode probe structure) ([0038]). By sharing the counter and reference electrodes, the total number of electrodes needed is decreased.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Wang, Sasso, and Teller such that one of the micropillar electrodes is configured as a counter electrode relative to the working electrode and another of the micropillar electrodes is configured as a reference electrode relative to the working electrode, thereby decreasing the total number of electrodes needed, as taught by Scherer ([0038]).
Regarding claim 8, the combination of Wang, Teller, and Scherer teaches the device of claim 5, wherein the device is configured to use an electrochemical detection selected from a group consisting of potentiometry, cyclic voltammetry (CV), fast scan cyclic voltammetry (FSCV), square wave voltammetry (SWV), or chronoamperometry (Wang, [0068]; “Potentiometric, voltammetric, amperometric, conductometric, and/or impedimetric detection methodologies can be integrated into one all-inclusive platform, e.g., in order to enable the direct biosensing of multiple analytes residing in bodily fluids (e.g., such as key biomarkers occupying the transdermal fluid)”).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Sasso in view of Teller, as applied to claim 1, in view of US Patent Publication 2017/0251958 by Pushpala et al. – previously cited, hereinafter “Pushpala”.
Regarding claim 9, the combination of Wang, Sasso, and Teller teaches the device of claim 1, but does not teach further comprising: a computer program product executable as a software application, resident on a mobile communication device in communication with the electronics unit, wherein the computer program product is configured to control one or more of (i) detection of electrochemical measurements conducted at the microneedle array sensor unit, (ii) data analysis, (iii) data transmission, or (iv) device power management.
Pushpala teaches a microsensor patch that is in communication with a mobile computing device via a linking interface ([0070, 0101]). A software module can be an application that performs data analysis, calculations, and other actions remotely from the mobile computing device. The software module can provide an analysis that can be useful in treating, maintaining, and/or improving a health condition of a user ([0099]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Wang, Sasso, and Teller to include a computer program product executable as a software application, resident on a mobile communication device in communication with the electronics unit, wherein the computer program product is configured to control one or more of (i) detection of electrochemical measurements conducted at the microneedle array sensor unit, (ii) data analysis, (iii) data transmission, or (iv) device power management, to provide analysis that includes information that can be useful in treating, maintaining, and/or improving a health condition of a user, as taught by Pushpala ([0099]).
Response to Arguments
Applicant’s arguments, filed 02/26/2026 have been fully considered.
The amendments to claims 2 and 24 overcome the objections of record.
Applicant’s arguments regarding the rejections under 35 U.S.C. 112(a) of claims 2 and 25 are found persuasive, and the rejections under 35 U.S.C. 112(a) and the corresponding rejections under 35 U.S.C. 112(b) are withdrawn.
The amendments to claims overcome the previous rejections of record under 35 U.S.C. 112(b) of claims 2, 8, 11, 13 and 24.
The amendments to the claim 13 overcome the rejection of record under 35 U.S.C. 101.
Applicant’s assertions regarding the rejection of claims 1 and 23 under 35 U.S.C. 103 is acknowledged. This assertion is moot as it is based on amendments to the claims not entered at the time of the previous Office action. The newly presented limitations are rejected on new grounds above.
Conclusion
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.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791