Prosecution Insights
Last updated: April 19, 2026
Application No. 17/755,211

SENSING DEVICES BASED ON MICRONEEDLE ARRAYS FOR SENSING APPLICATIONS INCLUDING KETONE BODIES MONITORING

Final Rejection §103
Filed
Apr 22, 2022
Examiner
WESTFALL, SARAH ANN
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
President and Fellows of Harvard College
OA Round
2 (Final)
0%
Grant Probability
At Risk
3-4
OA Rounds
3y 2m
To Grant
0%
With Interview

Examiner Intelligence

Grants only 0% of cases
0%
Career Allow Rate
0 granted / 5 resolved
-70.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
47 currently pending
Career history
52
Total Applications
across all art units

Statute-Specific Performance

§101
16.8%
-23.2% vs TC avg
§103
35.1%
-4.9% vs TC avg
§102
18.4%
-21.6% vs TC avg
§112
25.3%
-14.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 5 resolved cases

Office Action

§103
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 . 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. Claim Objections Claim 16 is objected to because of the following informalities: grammatical errors. Claim 16 recites “fluid through continuous amperometric electrochemically-mediated enzymatic reaction” whenever it should state “fluid through a continuous amperometric electrochemically-mediated enzymatic reaction”. Appropriate correction is required. 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 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). 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 that is unbound to the HBD enzyme. 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 that is unbound to an HBD enzyme 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) 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. Wang et. al.’879 also 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, per Oja et. al.’005, the redox mediator would be integrated in a material of the electrode structure of the first microneedle 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). Regarding Claim 21, Paragraph [0129] of Oja et. al.’005 teaches that the HBD-cofactor includes nicotinamide adenine dinucleotide (NAD+). Regarding Claim 29, Wang et. al.’879 in view of Oja et. al.’005 discloses the sensor device outlined in Claim 16. Additionally, Wang et. al.’879 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 to include a layer comprised of glucose oxidase and a mediator in order to detect glucose. Regarding Claim 33, Wang et. al.’879 in view of Oja et. al.’005 discloses the sensor device outlined in Claim 16. Additionally, Wang et. al.’879 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 to include a layer comprised of lactate oxidase and a mediator in order to detect lactate. Regarding Claim 38, Wang et. al.’879 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 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 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 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 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 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). 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) 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 discloses the sensor device outlined in Claim 16. Wang et. al.’879 also 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 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). Claims 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) 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 discloses the sensor device outlined in Claim 16. Wang et. al.’879 in view of Oja et. al.’005 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 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 discloses the sensor device outlined in Claim 16. Wang et. al.’879 in view of Oja et. al.’005 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 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). Claims 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) 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 discloses the sensor device outlined in Claim 16. Wang et. al.’879 in view of Oja et. al.’005 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 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. Claims 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) 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 discloses the sensor device outlined in Claim 16. Wang et. al.’879 in view of Oja et. al.’005 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 in order 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 discloses the sensor device outlined in Claim 16. Wang et. al.’879 in view of Oja et. al.’005 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 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. Claims 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) 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 discloses the sensor device outlined in Claim 29. Wang et. al.’879 in view of Oja et. al.’005 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.’189 in view of Oja et. al.’005 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 discloses the sensor device outlined in Claim 33. Wang et. al.’879 in view of Oja et. al.’005 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 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 19 September 2025 have been fully considered and they are not entirely persuasive. Applicant’s amendments have overcome the prior claim objections, but the amendments have also caused an additional objection as addressed by the examiner in Paragraph 3 above. Applicant’s amendments have overcome the prior rejections under 35 U.S.C. 112(b). 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 to be noted that the examiner considered the applicant’s arguments regarding Oja et. al.’005 “teaching away” from “a continuous amperometric electrochemically-mediated enzymatic reaction” but ultimately found these reasonings to not be persuasive. The examiner notes that Oja et. al.’005 recites using a continuous amperometric system as well as an accumulated system as addressed in Paragraph 4 above as well as in Paragraphs [0005], [0068], [0087], and [0091] of Oja et. al.’005. Furthermore, the examiner notes that Oja et. al.’005 teaches that although an accumulated system has benefits, an “accumulation mode” cannot always be used for an entire duration of measurement times whereas a continuous amperometric system does not have this issue (Paragraph [0091] - 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). Therefore, it would have been obvious for one of ordinary skill in the art at the time the invention was effectively filed to have used a system similar to Oja et. al.’005 that can use the system continuously when necessary or in an “accumulation mode” when necessary. 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. 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. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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 /ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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Prosecution Timeline

Apr 22, 2022
Application Filed
May 15, 2025
Non-Final Rejection — §103
Sep 19, 2025
Response Filed
Dec 20, 2025
Final Rejection — §103
Mar 30, 2026
Request for Continued Examination
Apr 13, 2026
Response after Non-Final Action

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Prosecution Projections

3-4
Expected OA Rounds
0%
Grant Probability
0%
With Interview (+0.0%)
3y 2m
Median Time to Grant
Moderate
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