CTNF 17/755,211 CTNF 100547 Detailed Action Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-06 AIA 15-10-15 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. Continued Examination Under 37 CFR 1.114 07-42-04 AIA A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 March 2026 has been entered. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 16-17, 21, 29, 33, and 38-43 rejected under 35 U.S.C. 103 as being unpatentable over Wang et. al.’879 (WO Publication Number 2013058879 – previously cited) in view of Oja et. al.’005 (U.S. Publication Number 20190004005 – previously cited), further in view of Zhang et. al.’2007 (Coimmobilization of Dehydrogenases and Their Cofactors in Electrochemical Biosensors ), and further in view of Gonnelli’838 (U.S. Patent Publication 20060030838) . Regarding Claim 16, Wang et. al.’879 discloses an electrochemical transducer used to detect biomarkers (Paragraph [0070] - electrochemical transducer that can detect patterns of biomarker changes), comprising: a substrate (Paragraph [0008] - a device includes a substrate that includes a microneedle); plurality of microneedle electrodes coupled to a substrate operable to penetrate skin in order for the microneedle electrodes to be in contact with the interstitial fluid (Paragraph [0070] - extract the physiological information of an analyte from a biological fluid (e.g., such as transdermal fluid)), wherein each microneedle structure includes an exterior wall spanning outward from a base surface of the microneedle structure and forming an apex at a terminus point of the exterior wall, and the electrode structure is configured within a hollow interior region of the microneedle structure or on at least a portion of the exterior wall of the microneedle structure (Paragraph [0065] - includes an exterior wall spanning outward from a base surface of the microneedle structure and forming an apex at a terminus point of the exterior wall, and the electrode structure is configured within a hollow interior region of the microneedle structure or on at least a portion of the exterior wall of the microneedle structure; Figures 1C and 1G); an enzymatic functionalization layer coupled to an electrode structure of a first microneedle electrode of a plurality of microneedle electrodes (Paragraph [0062] - an example of blood glucose monitoring, the microneedles can be functionalized with glucose oxidase enzyme (a biocatalyst) that is entrapped within a conducting polymer, e.g., in which the electrode component is conductive and functionalized (e.g., coated) to include the biocatalyst); and wherein a plurality of microneedle electrodes includes a counter electrode or a reference electrode, or both, configured to apply or detect an electrical signal between the counter electrode or reference electrode and the first microneedle electrode (Paragraph [0077] - metal electrodes, e.g., four working electrodes 202 and one counter electrode 207 and one or more reference electrode(s) 206, can be sputter deposited on the surface over the openings; Paragraph [00117] – used to establish a three-electrode electrochemical system). It is noted by the examiner that Wang et. al.’879 recites the ability for embodiments to include other elements within different embodiments (Paragraphs [0083, 00109, 00133, and 00148] - This embodiment can comprise the same embodiment(s) like those previously described, and can therefore implement the entirety of functionalities of the individual embodiments on a single embodiment). Wang et. al.’879 fails to disclose an enzymatic functionalization layer coupled to an electrode structure of a first microneedle electrode of a plurality of microneedle electrodes operable to detect Beta-hydroxybutyrate (HB) in the interstitial fluid through a continuous amperometric electrochemically-mediated enzymatic reaction, wherein the enzymatic functionalization layer is immobilized to the electrode structure of the first microneedle electrode and comprises a Beta-hydroxybutyrate dehydrogenase (HBD) enzyme and HBD-cofactor. Oja et. al.’005 teaches an enzymatic functionalization layer that is immobilized to an electrode structure and comprises a Beta-hydroxybutyrate dehydrogenase (HBD) enzyme and HBD-cofactor to detect Beta-hydroxybutyrate (HB) through a continuous amperometric electrically-mediated enzymatic reaction (Paragraph [0005] - amperometry has proven viable for measuring analytes such as glucose, which is present at relatively high physiological concentrations (at or above 5 millimolar (mM)); Paragraph [0068] - As used herein, an “electrochemical sensor” is a device configured to detect the presence and/or measure the level of an analyte in a sample via electrochemical oxidation and reduction reactions on the sensor. These reactions are transduced to an electrical signal that may be correlated to an amount, concentration, or level of an analyte in the sample; Paragraph [0087] - As shown, the amperometric current is not dependent on accumulation time and remains constant; Paragraph - [0091] - As shown in FIG. 5, both the amperometry (left graph) and the accumulation mode measurements (middle and right graphs) give a linear response to analyte concentration. As expected, using amperometry (left graph of FIG. 5), the sensitivity of the sensor is independent of the accumulation time…Furthermore, it is noted that a set period of time greater than 10 minutes for accumulation of charge using the accumulation mode sensing with continuously monitoring sensors may cause negative effects on the time resolution of the sensor; Paragraph [0128] - In some embodiments of the present disclosure, an analyte-specific enzyme is provided (e.g., immobilized) onto the working electrode in order to catalyze the oxidation of the analyte to be measured...In some embodiments, the analyte-specific enzyme is NAD-3-hydroxybutyrate dehydrogenase for oxidizing 3-hydroxy butyrate). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified a functionalization layer of Wang et. al.’879 to include beta-hydroxybutyrate dehydrogenase (HBD) and HBD-cofactor NAD in order to detect Beta-hydroxybutyrate (HB) as seen in Oja et. al.’005. Additionally, it is noted by the examiner that both Wang et. al.’879 and Oja et. al.’005 disclose using amperometric reactions to detect analytes. Oja et. al.’005 teaches that continuous amperometric reactions produce viable analyte measurements that are present at relatively high physiological concentrations (at or above 5 millimolar (mM)) (Paragraph [0005]) and operates at a consistent sensitivity that is independent of accumulated time applied (Paragraph [0091]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have used a system of Wang et. al.’879 in view of Oja et. al.’005 as a continuous amperometric device. Zhang et. al.’2007 teaches an unbound cofactor (Page 2446 Paragraph 2 - However, dehydrogenase-based biosensors are not yet a success story. This can be attributed to some restrictions in the use of dehydrogenases for the development of reagentless electrochemical biosensors. The primary limitation is that, in contrast to oxidases, which have redox cofactors tightly bound within their molecules, the cofactors are not bound to dehydrogenase molecules. Therefore, unlike the case of oxidase-based biosensors, dehydrogenase-based systems cannot be readily incorporated into reagentless devices. The latter systems require that both a dehydrogenase and its cofactor are immobilized in such a way that a cofactor has easy access to an enzyme; Page 2447 Paragraph 1 - The present paper describes the immobilization of glucose dehydrogenase (GDH) and its cofactor NAD+ on the scaffolds of a biopolymer chitosan (CHIT). The novelty of this approach is that the dehydrogenase and the cofactor are covalently attached to polymeric chains on the surface of the electrode and still have enough freedom of movement to react with each other and provide a sustainable amount of current in the presence of glucose in a solution). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Wang et. al.’879 in view of Oja et. al.’005 to include a substrate comprising crosslinked enzymes while enabling the HBD-cofactor to remain unbound in order to allow the cofactor more mobilization to access an enzyme of interest while simultaneously being immobilized to a substrate layer as seen in Zhang et. al.’2007. Wang et. al.’879 further discloses a hollow electrode needle comprising an opening from an exterior surface of the electrode to an interior portion of the electrode with sensing elements (Paragraph [0064] - The microneedle array 100 includes an array of hollowed microscale-sized needles 101, in which 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 a probe 102 formed inside the exterior wall to interact 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)), but fails to disclose wherein the enzymatic functionalization layer includes a crosslinked network including HBD enzyme and the HBD-cofactor extending within pores of the electrode structure, wherein the crosslinked network is configured such that the HBD enzyme and the HBD-cofactor are confined within the pores of the electrode structure. Oja et. al.’005 teaches crosslinking analyte specific enzymes on a substrate as a form of immobilization (Paragraph [0073] - As used herein, components are “immobilized” within a sensor, for example, when the components are entrapped on or covalently, ionically, or coordinatively bound to constituents of the sensor and/or are entrapped in a polymeric or sol-gel matrix or membrane which precludes mobility; Paragraph [0078] - In some embodiments, the sensing element includes an analyte specific enzyme, an electron transfer agent, and a crosslinker; Paragraph [0118] - In some embodiments, the electron transfer agent and analyte-specific enzyme are co-immobilized onto the working electrode with any suitable crosslinker). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Wang et. al.’879 to include crosslinking analyte-specific enzymes in order to immobilize those enzymes within a sensor device and create a more stable structure via lack of mobility as seen in Oja et. al.’005. Furthermore, Gonnelli’838 teaches binding enzymes within a needle interior (Paragraph [0105] - In an application for sensing based on binding to a substrate or reaction mediated by an enzyme, the substrate or enzyme can be immobilized in the needle interior, which would be especially useful in a porous needle to create an integral needle/sensor). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Wang et. al.’879 in view of Oja et. al.’005 and further in view of Zhang et. al.’2007 to include the analyte-specific substrates taught by Oja et. al.’005 and Zhang et. al.’2007 within the hollow portions of the electrode needles disclosed in Wang et. al.’879 in order to immobilize the sensing substrate within the device while creating an integral needle and sensor system as seen in Gonnelli’838. Wang et. al.’879 further fails to disclose a redox mediator coupled to the electrode structure of the first microneedle electrode to facilitate electron transfer in the electrochemically-mediated enzymatic reaction. Oja et. al.’005 teaches a redox mediator coupled to the electrode structure (Paragraph [0084] - an electron transfer agent (e.g., a redox mediator). The area of the working electrode that is modified with the analyte-specific enzyme and the redox mediator may be referred to as the sensing element or sensing layer of the working electrode). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified an electrode of Wang et. al.’879 to include a redox mediator as seen in Oja et. al.’005 in order to supply an electrode with a direct electron transfer agent. Oja et. al.’005 recites this can help the redox reaction to continue (Paragraph [0084] - the charge from the redox reaction will continue to accumulate). Regarding Claim 17, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the device outlined in Claim 16 above, but fails to disclose wherein the redox mediator is integrated in a material of the electrode structure of the first microneedle electrode. Oja et. al.’005 teaches a redox mediator would be integrated in a sensing material of an electrode (Paragraph [0077] - The sensing layer may include constituents such as an electron transfer agent (e.g., a redox mediator or a redox polymer), a catalyst (e.g., an analyte- specific enzyme) which catalyzes a reaction of the analyte to produce a response at the working electrode). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 to include in an electrode structure of Wang et. al.’879 a redox mediator in order to enable a response at a response from an analyte as seen in Oja et. al.’005. Regarding Claim 21, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the device outlined in Claim 16 above, as well as Oja et. al’005 teaches that the HBD-cofactor includes nicotinamide adenine dinucleotide (NAD+) in Paragraph [0129]. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 to include NAD as an HBD-cofactor in order to oxidize its corresponding analyte substrate as seen in Oja et. al.’005. Regarding Claim 29, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the sensor device outlined in Claim 16. Wang et. al.’879 further discloses a glucose-sensing enzymatic functionalization layer entrapped to an electrode structure that comprises a glucose oxidase (GOx) enzyme (Paragraph [0062]) while Paragraph [0084] of Oja et. al.’005 teaches that the redox mediator is on an electrode to facilitate electron transfer in a redox reaction. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified a functionalization layer of Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 to include a layer comprised of glucose oxidase and a mediator in order to detect glucose as seen in Oja et. al.’005. Regarding Claim 33, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the sensor device outlined in Claim 16. Wang et. al.’879 further discloses a lactate-sensing enzymatic functionalization layer on an electrode structure that comprises a lactate oxidase (LOx) enzyme (Paragraph [00148] - the disclosed microneedle electrode arrays included low-potential detection of hydrogen peroxide at rhodium-dispersed carbon paste microneedles in vitro and lactate biosensing by the inclusion of lactate oxidase in the metallized carbon paste matrix) while Paragraph [0084] of Oja et. al.’005 teaches that the redox mediator is on an electrode to facilitate electron transfer in a redox reaction. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified a functionalization layer of Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 to include a layer comprised of lactate oxidase and a mediator in order to detect lactate as seen in Oja et. al.’005. Regarding Claim 38, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the device outlined in Claim 16 above. Wang et. al.’879 further discloses an electrode structure of the first microneedle electrode is configured as a coating on at least a portion of a microneedle electrode (Paragraph [0087] - The solid microneedle constituent can be coated with a conductive material to form a working electrode). Regarding Claim 39, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the device outlined in Claim 16 above. Wang et. al.’879 further discloses at a portion of an exterior wall of the first microneedle electrode, a microneedle structure of a first microneedle electrode has an opening leading in to a hollow interior region of a microneedle structure of the first microneedle electrode that is defined by an interior wall, wherein an electrode structure of the first microneedle electrode is at least partially contained within a hollow region of the microneedle structure of the first microneedle electrode (Paragraph [0008] - the microneedle includes a wall with an opening to the hollowed interior, an electrode including a probe, in which the probe is disposed inside the hollowed interior, and a wire that is connected to the probe, in which the electrode is functionalized by a coating over the probe to interact with an analyte to produce an electrical signal). Regarding Claim 40, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the device outlined in Claim 16 above. Wang et. al.’879 further discloses wherein a microneedle structure of a plurality of microneedle electrodes includes a pyramidal geometry, a conical geometry, or a combination thereof (Paragraph [0095] - The hollow needles were pyramidal in shape with a triangular base). Regarding Claim 41, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the device outlined in Claim 16 above. Wang et. al.’879 further discloses a plurality of electrical conduits, each coupled to an electrode structure of microneedle electrodes and disposed on or within a substrate, wherein each electrical conduit terminates at an interface portion of an electrical conduit (Paragraph [0065] - 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). Regarding Claim 42, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the device outlined in Claim 41 above. Wang et. al.’879 further discloses an electrical circuit electrically connected to a plurality of electrical conduits to process an electrical signal as a processed signal (Paragraph [0008] - The device can further include a processing unit in communication with the wire that receives the electrical signal and uses the electrical signal as data. The processing unit can compare the data to a threshold value to determines…). Regarding Claim 43, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the device outlined in Claim 43 above. Wang et. al.’879 further discloses a wireless transmitter in communication with an electrical circuit to transmit a processed signal (Paragraph [0065] - 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; Paragraph [0072] - the biosensor-actuator device 180 can include a wireless transmitter/receiver on or remotely tethered (e.g., using wires) to the substrate facilitating the sensor-actuator microneedle arrays) . 07-21-aia AIA Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et. al.’879 (WO Publication Number 2013058879 – previously cited) in view of Oja et. al.’005 (U.S. Publication Number 20190004005 – previously cited), further in view of Zhang et. al.’2007 (Coimmobilization of Dehydrogenases and Their Cofactors in Electrochemical Biosensors ), and further in view of Gonnelli’838 (U.S. Patent Publication 20060030838), as applied in Claim 16, further in view of Carney et. al.’166 (U.S. Publication Number 20070255166 – previously cited) . Regarding Claim 18, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the sensor device outlined in Claim 16. Wang et. al.’879 further discloses an electrode structure of a microneedle electrode includes a carbon paste transducer (Paragraph [00133] - a minimally-invasive multi- component microneedle device with carbon paste electrodes within a hollow microneedle array for electrochemical monitoring and biosensing). Wang et. al.’879 in view of Oja et. al.’005 fails to disclose a carbon paste transducer comprising (i) one or more of graphite, carbon nanotubes, or graphene and (ii) a pasting liquid comprising one or more of ionic liquid (IL) or mineral oil. Carney et. al.’166 teaches a carbon paste transducer comprising (i) one or more of graphite, carbon nanotubes, or graphene and (ii) a pasting liquid comprising one or more of ionic liquid (IL) or mineral oil (Paragraph [0021] - electrically conductive paste, polymer gel or adhesive. Examples include pastes containing carbon-graphite or silver powder, conductive gaskets, conductive polymers such as polypyrrole, polyacetylene and polyaniline, conductive carbon or metal nanoparticle filled oil or polymer with a glass transition temperature lower than room temperature, and liquid metals). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 comprising a carbon paste transducer of Wang et. al.’879 to include carbon-graphite and liquid metals as seen in Carney et. al.’166. Carney et. al.’166 recites that this kind of paste is good to use for longevity without interfering with electrical connection (Paragraph [0022] - Eliminating the hard conductor interconnection between the transducer and the conductors allows the conductive pad 116 and the conductor 118 to move relative to each other without interfering with their electrical connection. Such a flexible system is ideal for an environment in which the transducer 108 will undergo repeated stresses over a long period of time) . 07-21-aia AIA Claim s 19 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et. al.’879 (WO Publication Number 2013058879 – previously cited) in view of Oja et. al.’005 (U.S. Publication Number 20190004005 – previously cited), further in view of Zhang et. al.’2007 (Coimmobilization of Dehydrogenases and Their Cofactors in Electrochemical Biosensors ), and further in view of Gonnelli’838 (U.S. Patent Publication 20060030838), as applied in Claim 16, further in view of Bandodkar et. al.’189 (WO Publication Number 2016090189 – previously cited) . Regarding Claim 19, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the sensor device outlined in Claim 16. Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 fails to disclose an electrode structure of a microneedle electrode includes a printable conductive ink, wherein an enzymatic functionalization layer coupled to an electrode structure of a first microneedle electrode includes a printable ink material entrapping an HBD enzyme and an HBD-cofactor within a printable ink material, and wherein a redox mediator is entrapped within one or both of a printable conductive ink and a printable ink material. Bandodkar et. al.’189 teaches printing conductive ink material onto an electrode that can include entrapping enzymes onto the electrode (Paragraph [00227] - inkjet printing the ion-selective membrane on the anterior surface of the electrode… entrapping the catalyst). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified a functionalization layer of Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 to be applied with a printable ink as seen in Bandodkar et. al.’189 in order to assist in the process that Bandodkar et. al.’189 recites will “facilitate the require electrochemical response” (Paragraph [00231]). Regarding Claim 37, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the sensor device outlined in Claim 16. Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 fails to disclose a counter electrode and/or a reference electrode includes carbon paste (CP) or an electrically conducive wire. Bandodkar et. al.’189 teaches a counter electrode and/or a reference electrode includes an electrically conducive wire (Paragraph [0006] - and an electrode interface assembly comprising independent electrically conductive conduits formed on the substrate and electrically coupled to each of the working, counter/reference, and reverse iontophoretic electrodes). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 comprising a reference electrode of Wang et. al.’879 to include an electrically conductive wire as seen in Bandodkar et. al.’189. Bandodkar et. al. recites that the conductivity will allow the electrodes to detect analytes whenever circuits are coupled or connected (Paragraph [0006] - when attached to the skin and electrically coupled to one or more electrical circuits via the electrode interface assembly, the device is operable to detect the analyte) . 07-21-aia AIA Claim s 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et. al.’879 (WO Publication Number 2013058879 – previously cited) in view of Oja et. al.’005 (U.S. Publication Number 20190004005 – previously cited), further in view of Zhang et. al.’2007 (Coimmobilization of Dehydrogenases and Their Cofactors in Electrochemical Biosensors ), and further in view of Gonnelli’838 (U.S. Patent Publication 20060030838), as applied in Claim 16, further in view of Mujeeb-U-Rahman et. al.’301 (WO Publication Number – previously cited) . Regarding Claims 27 and 28, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the sensor device outlined in Claim 16. Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 fails to disclose an enzymatic functionalization layer is immobilized to an electrode structure of a first microneedle electrode by a cross-linking agent wherein the cross-linking agent comprises glutaraldehyde. Mujeeb-U-Rahman et. al.’301 teaches an enzymatic functionalization layer with a cross-linking agent glutaraldehyde (Paragraph [00136] – the enzyme is immobilized on the sensing element… this can be done through immobilization of the enzyme such as GOx in a hydrogel created by proteinaceous material with glutaraldehyde as the crosslinking agent). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified a functionalization layer of Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 to include a cross-linking element such as glutaraldehyde in order to immobilize an element onto an electrode or sensing element as seen in Mujeeb-U-Rahman et. al.’301 . 07-21-aia AIA Claim s 20 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et. al.’879 (WO Publication Number 2013058879 – previously cited) in view of Oja et. al.’005 (U.S. Publication Number 20190004005 – previously cited), further in view of Zhang et. al.’2007 (Coimmobilization of Dehydrogenases and Their Cofactors in Electrochemical Biosensors ), and further in view of Gonnelli’838 (U.S. Patent Publication 20060030838), as applied in Claim 16, further in view of Ayyub et. al.’310 (U.S. Publication Number 20160231310 – previously cited) . Regarding Claim 20, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the sensor device outlined in Claim 16. Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 fails to disclose an enzymatic functionalization layer that includes a hydrogel coating that entraps an HBD enzyme, an HBD-cofactor, and a redox mediator within a hydrogel material. Ayyub et. al.’310 teaches a hydrogel coating that entraps enzymes within a hydrogel material (Paragraph [0164] - wherein the biosensor comprises a metabolic enzyme covalently bound or immobilized within the coating, wherein the coating comprises a composition comprising a hydrogel matrix). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified a functionalization layer of Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 to include a hydrogel coating as seen in Ayyub et. al.’310 as a way to immobilize or trap an enzyme as recited by Ayyub et. al.’310 (Paragraph [0015] - Hydrogel formulations are used to entrap one or more enzymes). Regarding Claim 25, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the sensor device outlined in Claim 16. Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 fails to disclose the sensor device further comprising an outer layer including at least one polymeric layer. Ayyub et. al.’310 teaches a sensor device comprising a layer including at least one polymeric layer (Paragraph [0160] - The hydrogel may be a cross-linked polymeric material that swells in water but does not dissolve). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified an electrode of a sensor device of Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 to include a polymeric layer as seen in Ayyub et. al.’310 to ensure the chosen material can take in water to gather readings but will not dissolve . 07-21-aia AIA Claim s 31 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et. al.’879 (WO Publication Number 2013058879 – previously cited) in view of Oja et. al.’005 (U.S. Publication Number 20190004005 – previously cited), further in view of Zhang et. al.’2007 (Coimmobilization of Dehydrogenases and Their Cofactors in Electrochemical Biosensors ), and further in view of Gonnelli’838 (U.S. Patent Publication 20060030838), as applied in Claims 29 and 33 respectively, further in view of Bommakanti et. al.’994 (U.S. Publication Number 20110124994 – previously cited) . Regarding Claim 31, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the sensor device outlined in Claim 29. Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 fails to disclose glucose-sensing enzymatic functionalization layer further includes a permeable polymer film that immobilizes GOx and a mediator to an electrode structure of a second microneedle electrode. Bommakanti et. al.’994 teaches enzymatic functionalization layer that senses glucose and includes a permeable membrane acting as a polymer film (Paragraph [0119] - The sensing layer may be covered by one or more layers, e.g., a membrane that is selectively permeable to glucose. Once the glucose passes through the membrane, it is oxidized by the enzyme). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified a functionalization layer of Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 to include a permeable membrane as seen in Bommakanti et. al.’994 in order to be selective about what analytes are being analyzed. Regarding Claim 35, Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 discloses the sensor device outlined in Claim 33. Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 fails to disclose a lactate-sensing enzymatic functionalization layer further includes a permeable polymer film that immobilizes LOx and a mediator to an electrode structure of a third microneedle electrode. Bommakanti et. al.’994 teaches an enzymatic functionalization layer that senses lactate and includes a permeable membrane acting as a polymer film (Paragraph [0119] - The sensing layer may be covered by one or more layers, e.g., a membrane that is selectively permeable to glucose. Once the glucose passes through the membrane, it is oxidized by the enzyme; Paragraph [0104] – A sensing layer that...facilitates the electrooxidation of the glucose, lactate, or oxygen, respectively; Paragraph [0112] – The sensing layer…a lactate oxidase or lactate dehydrogenase may be used when the analyte of interest is lactate). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified a functionalization layer of Wang et. al.’879 in view of Oja et. al.’005 further in view of Zhang et. al.’2007 and further in view of Gonnelli’838 include a permeable membrane as seen in Bommakanti et. al.’994 in order to be selective about what substrates are being analyzed. Response to Amendment Applicant's arguments filed 30 March 2026 have been fully considered and they are not entirely persuasive. Applicant’s amendments have overcome the prior claim objections. Claims 16-21, 25, 27-29, 31, 33, 35 and 37-43 are rejected under 35 U.S.C. 103 with additional references cited as necessitated by amendments, as discussed in Paragraphs 4-9 above. It is believed that the previous prior art of record in combination with the new prior art recited in the above paragraphs, teach the amended limitations. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SARAH ANN WESTFALL/Examiner, Art Unit 3791 /AURELIE H TU/Primary Examiner, Art Unit 3791 Application/Control Number: 17/755,211 Page 2 Art Unit: 3791 Application/Control Number: 17/755,211 Page 3 Art Unit: 3791 Application/Control Number: 17/755,211 Page 4 Art Unit: 3791 Application/Control Number: 17/755,211 Page 5 Art Unit: 3791 Application/Control Number: 17/755,211 Page 6 Art Unit: 3791 Application/Control Number: 17/755,211 Page 7 Art Unit: 3791 Application/Control Number: 17/755,211 Page 8 Art Unit: 3791 Application/Control Number: 17/755,211 Page 9 Art Unit: 3791 Application/Control Number: 17/755,211 Page 10 Art Unit: 3791 Application/Control Number: 17/755,211 Page 11 Art Unit: 3791 Application/Control Number: 17/755,211 Page 12 Art Unit: 3791 Application/Control Number: 17/755,211 Page 13 Art Unit: 3791 Application/Control Number: 17/755,211 Page 14 Art Unit: 3791 Application/Control Number: 17/755,211 Page 15 Art Unit: 3791 Application/Control Number: 17/755,211 Page 16 Art Unit: 3791 Application/Control Number: 17/755,211 Page 17 Art Unit: 3791 Application/Control Number: 17/755,211 Page 18 Art Unit: 3791 Application/Control Number: 17/755,211 Page 19 Art Unit: 3791 Application/Control Number: 17/755,211 Page 20 Art Unit: 3791 Application/Control Number: 17/755,211 Page 21 Art Unit: 3791
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