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 .
Examiner’s Note
The following is a second Non-Final Rejection in light of Applicant’s identification of errors from the previous Examiner.
Response to Amendment
The amendment filed September 24, 2025 has been entered.
Claims 1-8, 10-30 are pending. Claim 9 has been cancelled.
Claims 3 and 13-20 are withdrawn from examination.
Claims 21-30 are new.
Claims 1, 2, 4-8, 10-12, and 21-30 are presently examined.
In light of further examination, new grounds of rejection have been presented under 35 U.S.C. 112(a), 112(b), and 103.
Response to Argument
Applicant’s arguments regarding the previous rejections under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Re. Claim 4: Claim 4 recites the limitation “regenerating the target molecule.” The mechanism of regeneration appears to be described for a template molecule (Paragraphs 0055. 0057), but not target molecule [emphasis added].
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.
Claim 4 is 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.
Re. Claim 4: It is unclear how the claimed sensor module performs the action of detecting a target molecule by performing the step of electro-deposition. As best understood, this is a step of a method of manufacturing prior to the formation of the compound sensor molecule; furthermore, such a limitation makes the statutory category of the claim unclear. Examiner recommends presenting separate claims directed to methods of manufacturing and actions carried out by the sensing module.
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, 5-8, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over:
Wang et al. (US 20200337641 A1) (hereinafter – Wang) in view of
Heikenfeld et al. (US 20190254579 A1) (disclosed by Applicant) (hereinafter -- Heikenfeld).
Re. Claim 1: Wang teaches a biosensor patch (Figs. 1A, 1B).
Wang does not teach the invention further comprising an iontophoresis module configured to stimulate production of a biofluid sample.
Heikenfeld teaches analogous art in the technology of patch-type biosensor devices (Paragraph 0058). Heikenfeld further teaches the invention further comprising an iontophoresis module configured to stimulate production of a biofluid sample (Fig. 5, as described at Paragraph 0067: “The device includes a biofluid sample collector 570 which in some embodiments is… an iontophoresis electrode and hydrogel with a carbachol sweat stimulant for collecting sweat, or other suitable means to provide biofluid access”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Wang to include the iontophoresis module and accompanying elements thereof as taught by Heikenfeld, the motivation being that doing so allows for the stimulation of sweat production (Heikenfeld, Paragraph 0067: a variety of sweat stimulating methods may be used) without requiring the user to perform, e.g., exercise to allow for sampling of sweat as described in Paragraph 0116 of Wang.
Wang as modified by Heikenfeld further teaches the invention further comprising:
a microfluidic collection and sampling module configured to collect and sample the biofluid sample stimulated by the iontophoresis module (Figs. 1A, 1B: see microfluidic channels in layers 130, 120, 125); and
an electrochemical analyte sensor module configured with recognition elements to bind to and detect target molecules present in the biofluid sample stimulated by the iontophoresis module and collected in the microfluidic collection and sampling module (Paragraph 0004: “Sensors based on electrochemical processes can be used to detect a chemical substance or a biological substance (e.g., an organism) by using a transducing element to convert a detection event into a signal for processing and/or display. Biosensors can use biological materials as the biologically sensitive component, e.g., such as biomolecules including enzymes, antibodies, nucleic acids, etc., as well as living cells;” Fig. 4A; Fig. 6: molecularly-oriented enzyme; Fig. 8B: sodium and potassium sensing using exchange membranes; Paragraph 0068: “Afterwards, screen-printing is performed over current collectors with silver (Ag)/silver chloride (AgCl) (Ag/AgCl layer 141) and Prussian Blue (PB layer 145). Finally, a catalyst or reactant layer 146 (e.g., enzyme layer) is drop-casted over working electrode surface.”).
Re. Claim 5: Wang as modified by Heikenfeld teaches the invention according to claim 1. Wang further teaches the invention wherein the microfluidic collection and sampling module comprises:
inlets, each inlet providing a channel for the inflow of the biofluid sample (Figs. 1B, 1B: inlets 124A, 124B, 124C (as described in Paragraph 0046)); and
a reservoir connected to the inlets such that refreshed biofluid samples accumulate in the reservoir (Fig. 1A: reservoir 123 and outlet 125, as described at Paragraph 0049: particularly, “… thereby enabling freshly secreted fluid to enter”); and
an outlet providing a channel for the outflow of the biofluid sample (Fig. 1A: outlet 125 and channels connected thereto).
Re. Claim 6: Wang as modified by Heikenfeld teaches the invention according to claim 5. Wang further teaches the invention comprising a multi-inlet configuration wherein the inlets are positioned relative to the reservoir at a selected angular span and wherein the inlet channels follow a selected orientation relative to the reservoir (Figs. 1A, 1B: inlets positioned at radial spans from reservoir 123).
Re. Claim 7: Wang as modified by Heikenfeld teaches the invention according to claim 6. While Wang states six inlets were chosen to reach a plateau of roughly eight minutes in order to fill the device (Paragraph 0100), Examiner notes that the roughly eight minute fill time is an approximation, and Fig. 2A shows a small level of improvement in fill time beyond having six inlets.
Thus, It would have been obvious to one having skill in the art before the effective filing date to have modified Wang as modified by Heikenfeld to utilize, e.g., seven inlets, to provide a slight improvement in fill time for the device, since doing so provides a further improvement in fill time in scenarios where such a short fill time is required.
Regarding claim requirement of the angular span of inlets being about 180 degrees, Wang teaches a measurement arrangement having inlets arranged within a particular angular span and also further contemplates incorporation of greater than four inlets (see discussion above). Examiner notes that Applicant’s disclosure does not detail any criticality or unexpected results regarding requiring inlets spanning specifically about 180 degrees. As such, without a showing of criticality or unexpected results it would have been within the skill level of the art before the effective filing date of the claimed invention to determine an optimized span given a number of inlets, since it has generally been held to be within the skill level of the art to perform routine experimentation to determine optimal operation parameters.
Re. Claim 8: Wang as modified by Heikenfeld teaches the invention according to claim 1. Wang further teaches the invention wherein the biosensor patch further comprises:
an accumulation layer comprising accumulation wells and adhesive, wherein the accumulation layer is affixed to a skin area with the adhesive and wherein biofluid accumulating on the skin surface is collected in the accumulation wells (Fig. 1A: adhesion layer 130 comprising holes (i.e., accumulation wells) and adhesive as described at Paragraph 0091: “The example device was applied to the skin using a medical-grade double-sided adhesive layer (e.g., adhesive layer 130)…”);
an inlet layer affixed to the accumulation layer, the inlet layer comprising inlets wherein biofluid flows from the accumulation wells into the inlets (Figs. 1B, 1B: inlets 124A, 124B, 124C (as described in Paragraph 0046) located on layer above holes 131, i.e., accumulation wells; Examiner notes that the portion of layer 120 comprising a vertical inlet (e.g., Fig. 1B: inlet 124C) may be considered an inlet layer with a thickness of the height of the vertical inlet);
a channel layer affixed to the inlet layer, the channel layer comprising a plurality of channels wherein the biofluid sample flows from the inlets into the channels (Fig. 1A: layer 120 contains microfluidic channels flowing from inlets 124; Paragraph 0046: “… the inlets 124 can be connected to the channel 121 by tributary channels that span off of the channel 121 to the inlets 124;” Fig. 1B: Examiner notes that the channels which connect to channel 121 are above a portion of layer 120 containing vertical portions of inlets);
a reservoir layer affixed to the channel layer, the reservoir layer comprising a reservoir and a first outlet and wherein the biofluid sample flows from the channels into the reservoir and, after sampling of the biofluid, the biofluid sample exits through the first outlet (Fig. 1A: reservoir 123 can be considered a layer affixed to the layer 120 comprising channels; Fig. 1A: see portion of channel 125 attached to reservoir 123, which can be considered a first outlet, i.e., an exit from the reservoir 123); and
a flexible plastic electrode layer affixed to the reservoir layer configured with a second outlet providing for the exit of the biofluid sample (Fig. 1B: see electrodes located on layer 110 and interacting with channel 125, whereby the combination forms a second outlet “enabling freshly secreted fluid to enter” as described at Paragraph 0049; Paragraph 0050: “In some embodiments, the flexible layer 110, flexible layer 120, and the adhesion layer 130 are flexible and electrically insulating material. Non-limiting examples of flexible and electrically insulating materials of the first layer 110, second layer 120 and/or adhesion layer 130 include polydimethylsiloxane (PDMS), thiolenes, elastomers, liquid metals, and tegarderms”).
Re. Claim 11: Wang as modified by Heikenfeld teaches the invention according to claim 1. Wang further teaches the invention further comprising an in situ signal processing and wireless communication module (Paragraph 0057: “In another embodiment, the electronic unit of the device includes a signal conditioning circuit to amplify signals detected by the electrochemical sensor, a data processing unit including a processor and memory to process data based on the measured signals, and a wireless communications unit to wirelessly transmit the processed signals to an external device. In some embodiments, the wireless communications unit includes a Bluetooth Low-Energy (BLE) chipset”).
Re. Claim 12: Wang as modified by Heikenfeld teaches the invention according to claim 1. Wang further teaches the invention further comprising adhesive backing for direct application to skin (Fig. 1A: adhesion layer 130).
Claims 2, 21-24, and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over:
Wang et al. (US 20200337641 A1) (hereinafter – Wang) in view of
Heikenfeld et al. (US 20190254579 A1) (disclosed by Applicant) (hereinafter -- Heikenfeld) in further view of
Vital et al. (US 11065164 B1) (hereinafter – Vital).
Re. Claim 2: Wang as modified by Heikenfeld teaches the invention according to claim 1, but does not teach the invention wherein the analyte detection module comprises a molecularly imprinted polymer (MIP) organic compound sensor module, wherein the MIP is imprinted to match binding sites of the target molecules to detect the target molecules present in the biofluid sample collected in the microfluidic collection and sampling module.
Vital teaches analogous art in the technology of wearable body fluid sensors (Abstract). Vital further teaches that detection of biomarkers may include using electrodes having molecular imprint polymers as a capture species (Col. 10, lines 56-62: “The electrode 211 may be configured for selective entrapment and identification of biomarkers using molecularity imprinted polymers (MIPs) in the sensor electrode for selective entrapment of one or more biomarkers (e.g., uric acid) for impedance measurements”).
It would have been obvious to one having skill in the art before the effective filing date to have modified the sensors of Wang as modified by Heikenfeld to include MIPs as taught by Vital, the motivation being that MIPs are chemically and physically stable under a wide range of temperatures, cost-effective since they are not biologically derived, and can be engineered to have high selectivity to reduce cross-reactivity with non-target analytes, and further allows for sensing of additional biomarkers such as e.g., uric acid.
Re. Claim 21: Wang teaches a biosensor patch (Figs. 1A, 1B).
Wang does not teach the invention further comprising an iontophoresis module configured to stimulate production of a biofluid sample.
Heikenfeld teaches analogous art in the technology of patch-type biosensor devices (Paragraph 0058). Heikenfeld further teaches the invention further comprising an iontophoresis module configured to stimulate production of a biofluid sample (Fig. 5, as described at Paragraph 0067: “The device includes a biofluid sample collector 570 which in some embodiments is… an iontophoresis electrode and hydrogel with a carbachol sweat stimulant for collecting sweat, or other suitable means to provide biofluid access”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Wang to include the iontophoresis module and accompanying elements thereof as taught by Heikenfeld, the motivation being that doing so allows for the stimulation of sweat production (Heikenfeld, Paragraph 0067: a variety of sweat stimulating methods may be used) without requiring the user to perform, e.g., exercise to allow for sampling of sweat as described in Paragraph 0116 of Wang.
Wang as modified by Heikenfeld further teaches the invention comprising:
a microfluidic collection and sampling module, comprising:
an accumulation layer comprising accumulation wells and an adhesive configured to affix the accumulation layer to the skin and collect sweat pooling on the skin (Fig. 1A: adhesion layer 130 comprising holes (i.e., accumulation wells) and adhesive as described at Paragraph 0091: “The example device was applied to the skin using a medical-grade double-sided adhesive layer (e.g., adhesive layer 130)…”);
an inlet layer affixed to the accumulation layer and comprising a plurality of inlets fluidly coupled to the accumulation wells (Figs. 1B, 1B: inlets 124A, 124B, 124C (as described in Paragraph 0046) located on layer above holes 131, i.e., accumulation wells; Examiner notes that the portion of layer 120 comprising a vertical inlet (e.g., Fig. 1B: inlet 124C) may be considered an inlet layer with a thickness of the height of the vertical inlet);
a channel layer affixed to the inlet layer and defining a plurality of channels fluidly coupled to the inlets (Fig. 1A: layer 120 contains microfluidic channels flowing from inlets 124; Paragraph 0046: “… the inlets 124 can be connected to the channel 121 by tributary channels that span off of the channel 121 to the inlets 124;” Fig. 1B: Examiner notes that the channels which connect to channel 121 are above a portion of layer 120 containing vertical portions of inlets);
a reservoir fluidly coupled to the plurality of channels and an outlet, the reservoir being configured such that refreshed sweat sampled accumulate in the reservoir and, after sampling, are directed toward the outlet (Fig. 1A: reservoir 123 can be considered a layer affixed to the layer 120 comprising channels; Fig. 1A: see portion of channel 125 attached to reservoir 123, which can be considered a first outlet, i.e., an exit from the reservoir 123); and
an electrochemical analyte sensor module positioned to contact sweat downstream of the reservoir and (Paragraph 0004: “Sensors based on electrochemical processes can be used to detect a chemical substance or a biological substance (e.g., an organism) by using a transducing element to convert a detection event into a signal for processing and/or display. Biosensors can use biological materials as the biologically sensitive component, e.g., such as biomolecules including enzymes, antibodies, nucleic acids, etc., as well as living cells;” Fig. 4A; Fig. 6: molecularly-oriented enzyme; Fig. 8B: sodium and potassium sensing using exchange membranes; Paragraph 0068: “Afterwards, screen-printing is performed over current collectors with silver (Ag)/silver chloride (AgCl) (Ag/AgCl layer 141) and Prussian Blue (PB layer 145). Finally, a catalyst or reactant layer 146 (e.g., enzyme layer) is drop-casted over working electrode surface”).
Wang as modified by Heikenfeld does not teach the invention comprising electrodes with molecularly imprinted polymer (MIP) recognition elements configured to selectively bind target molecules present in the sweat and to generate an electrochemical signal indicate of a concentration of the target molecules.
Vital teaches analogous art in the technology of wearable body fluid sensors (Abstract). Vital further teaches that detection of biomarkers may include using electrodes having molecular imprint polymers as a capture species (Col. 10, lines 56-62: “The electrode 211 may be configured for selective entrapment and identification of biomarkers using molecularity imprinted polymers (MIPs) in the sensor electrode for selective entrapment of one or more biomarkers (e.g., uric acid) for impedance measurements”).
It would have been obvious to one having skill in the art before the effective filing date to have modified the sensors of Wang as modified by Heikenfeld to include MIPs as taught by Vital, the motivation being that MIPs are chemically and physically stable under a wide range of temperatures, cost-effective since they are not biologically derived, and can be engineered to have high selectivity to reduce cross-reactivity with non-target analytes, and further allows for sensing of additional biomarkers such as e.g., uric acid.
Re. Claim 22: Wang as modified by Heikenfeld and Vital teaches the invention according to claim 21. Heikenfeld further teaches the invention wherein the iontophoresis module further comprises a hydrogel sweat-stimulating agent positioned adjacent the electrodes, the hydrogel comprising carbachol gel (Fig. 5, as described at Paragraph 0067: “The device includes a biofluid sample collector 570 which in some embodiments is… an iontophoresis electrode and hydrogel with a carbachol sweat stimulant for collecting sweat, or other suitable means to provide biofluid access”).
Re. Claim 23: Wang as modified by Heikenfeld and Vital teaches the invention according to claim 21. Regarding arrangement and number of inlets, see rejection of claim 7.
Re. Claim 24: Wang as modified by Heikenfeld and Vital teaches the invention according to claim 21. Wang further teaches the invention wherein the accumulation, inlet, channel, and reservoir layers comprise patterned medical adhesive laminates (Fig. 1A: each layer comprises portions having patterns (e.g., holes or channels) and is in contact with at least one adhesive; Paragraph 0064: “Photolithography was then used to pattern the microfluidic channels;” see also Paragraphs 0127-0136 regarding fabrication process involving at adhesion steps),
comprising a bottom double- sided adhesive layer defining the accumulation wells (Paragraph 0091: “The example device was applied to the skin using a medical-grade double-sided adhesive layer (e.g., adhesive layer 130);” Figs. 1A, 1B: holes 131 defined in layer 130).
Re. Claim 27: Wang as modified by Heikenfeld and Vital teaches the invention according to claim 21. Wang further teaches the invention further comprising a temperature sensor and an electrolyte sensor (Paragraph 0054: “In some implementations, the device 100 is operable to detect one or more biomarkers. Non-limiting examples of biomarkers include electrolytes, glucose, lactate, pro-inflammatory cytokines, anti-inflammatory cytokines, catecholamines, neuropeptides, and/or proteins. In some implementations, the device 100 is operable to detect two or more electrolytes secreted from the sweat of the user. Non-limiting examples of electrolytes include sodium, potassium, chloride, bicarbonate, calcium, phosphate, magnesium, copper, zinc, iron, manganese, molybdenum, copper, and chromium”).
Re. Claim 28: Wang as modified by Heikenfeld and Vital teaches the invention according to claim 21. Wang further teaches the invention further comprising an in situ signal processing and wireless communication module configured to transmit analyte measurements to a mobile device via Bluetooth or Wi-Fi (Paragraph 0057: “In another embodiment, the electronic unit of the device includes a signal conditioning circuit to amplify signals detected by the electrochemical sensor, a data processing unit including a processor and memory to process data based on the measured signals, and a wireless communications unit to wirelessly transmit the processed signals to an external device. In some embodiments, the wireless communications unit includes a Bluetooth Low-Energy (BLE) chipset”).
Re. Claim 29: Wang as modified by Heikenfeld and Vital teaches the invention according to claim 21. Wang further teaches the invention further comprising a power source selected from the group consisting of
a lightweight battery (Paragraph 0138: “The PCB was powered by a lithium (Li) ion rechargeable battery”),
a biofluid-powered system (Paragraph 0057: “In some embodiments, the electronics unit is configured to supply electrical energy to the electrochemical sensor. In some embodiments, the device 100 further comprises a biofuel cell, wherein the device 100 includes the electronics unit electrically coupled to the electrochemical sensor via electrical interconnects and the biofuel cell”),
a solar cell, and
a motion-powered energy harvester.
Re. Claim 22: Wang as modified by Heikenfeld and Vital teaches the invention according to claim 21. Wang further teaches the invention wherein the microfluidic collection and sampling module further comprises a flexible plastic electrode layer affixed to the reservoir layer and defining a second outlet through which sampled sweat exits (Fig. 1B: see electrodes located on layer 110 and interacting with channel 125, whereby the combination forms a second outlet “enabling freshly secreted fluid to enter” as described at Paragraph 0049; Paragraph 0050: “In some embodiments, the flexible layer 110, flexible layer 120, and the adhesion layer 130 are flexible and electrically insulating material. Non-limiting examples of flexible and electrically insulating materials of the first layer 110, second layer 120 and/or adhesion layer 130 include polydimethylsiloxane (PDMS), thiolenes, elastomers, liquid metals, and tegarderms”).
Claims 4, 10, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over:
Wang et al. (US 20200337641 A1) (hereinafter – Wang) in view of
Heikenfeld et al. (US 20190254579 A1) (disclosed by Applicant) (hereinafter -- Heikenfeld) in further view of
Vital et al. (US 11065164 B1) (hereinafter – Vital) in further view of
Lu, Zhiwei, et al. "Novel flexible bifunctional amperometric biosensor based on laser engraved porous graphene array electrodes: Highly sensitive electrochemical determination of hydrogen peroxide and glucose." Journal of hazardous materials 402 (2021): 123774. (hereinafter – Lu).
Re. Claim 10 (presented first for clarity of claim ordering): Wang as modified by Heikenfeld and Vital teaches the invention according to claim 2, but does not teach the invention wherein the analyte sensor module is fabricated using laser-engraved graphene technology (LEG).
Lu teaches analogous art in the technology of graphene-based biosensors (Title; Abstract). Lu further teaches the invention wherein the analyte sensor module is fabricated using laser-engraved graphene technology (LEG) (Page 9: “The direct laser engraving on flexible PI film is a low cost and high-efficiency methodology to fabricate porous network graphene. This unique structure of LEPG was successfully functionalized with Pt NPs by CV electrodeposition to form Pt-LEPG, exhibiting good conductivity and excellent sensitivity for H2O2 sensing. As a result, it can be immobilized glucose oxidase (GOD) and effectively electro-catalyze glucose oxidation in near-neutral pH conditions. Response in the concentration range from 0.01 mM to 31.5 mM is linear, with an ultralow LOD of 0.3 μM (S/N =3). Due to its excellent performance, LEPG materials have great potentials in the application of flexible energy storage and sensing electronic devices.”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Wang as modified by Heikenfeld and Vital to include formation of an analyte sensor as taught by Lu, the motivation being that doing so provides a biosensor for both glucose and peroxide with a wide range and linear high sensitivity (Abstract).
Re. Claim 4: Wang as modified by Heikenfeld, Vital, and Lu teaches the invention according to claim 10. Lu, in teaching further detail regarding the incorporated subject matter, further teaches the invention wherein the MIP organic compound sensor module is configured to detect the target molecule by:
performing electro-deposition of a redox-active nanoreporter (RAR) layer onto the LEG (Page 3: “The synthesis of Pt NPs modification LEPG was performed via the in-situ electrochemical deposition method.”);
regenerating the target molecule (as best understood a template molecule is regenerated as indicated at page 6: “…the modified electrodes exhibited a pair of well-distinct redox characteristic peaks;” Examiner notes that the nanoparticles of the sensor are not consumed across redox reactions and may be used in subsequent detection cycles);
recognizing the target molecule (Page 3: “The glucose molecules are oxidized by GOD (flavin adenine dinucleotide, FAD) to gluconolactone, the active center of enzyme (FAD) is reduced to FADH2 at the same time (Scheme 1e). However, FADH2 can reduce oxygen to H2O2 and itself is oxidized to FAD. Combined with Pt NPs catalytic oxidation of H2O2 and voltammetric response, a highly sensitive electrochemical glucose sensing was established on GOD/Pt-LEPG.”);
measuring a decrease in oxidation peak at the RAR layer (Page 7: “Mean while, for Pt-LEPG, the oxidation peak current is +184.12 μA at +0.5 V while reduction peak current is -400.28 μA at -0.5 V, which is 7.37 times for anodic current response than of LEPG (24.98 μA) and 2.64 times for cathode current response than of LEPG (-151.30 μA), respectively.”); and
detecting the concentration of the target molecules based indirectly on a measured decreased oxidation peak (see previous citation).
Re. Claim 25: Wang as modified by Heikenfeld and Vital teaches the invention according to claim 21, but does not teach the invention wherein the electrodes of the electrochemical analyte sensor module are fabricated using laser-engraved graphene (LEG) technology.
Lu teaches analogous art in the technology of graphene-based biosensors (Title; Abstract). Lu further teaches the invention wherein electrodes are formed via laser-engraved graphene technology. See rejection of claim 10.
Thus, Wang as modified by Heikenfeld, Vital, and Lu teaches the invention according to claim 25.
Re. Claim 26: Wang as modified by Heikenfeld, Vital, and Lu teaches the invention according to claim 25. Lu teaches that fabrication of an electrode via electrodeposition of platinum nanoparticles on an laser-engraved graphene layer (Page 3: “The synthesis of Pt NPs modification LEPG was performed via the in-situ electrochemical deposition method”). Incorporating the MIP of vital requires surface modification of the LEG electrode taught by Lu. The resultant electrode performs detects a concentration of target molecule via changes in oxidation peaks with an altered capture species. Thus, Wang as modified by Heikenfeld, Vital, and Lu still teaches the invention according to claim 26, wherein a redox-active nanoreporter (RAR) layer is electro-deposited between the LEG electrodes and the MIP recognition elements, and the analyte sensor module is configured to detect the concentration of the target molecules indirectly based on a decrease in an oxidation peak at the RAR layer.
Conclusion
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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