DETAILED CORRESPONDENCE
Summary
This is the initial Office Action based on the Campbell, et al. application filed with the Office on 1 October 2025.
Claims 175-204 are currently pending and have been fully considered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application is a continuation application in a series of patent applications (18/630,936; 18/086,543; PCT/US2021/043786), which ultimately claim priority to a US Provisional Patent Application, 63/058,275, filed on 29 July 2020. Thus, 29 July 2020 is the effective filing date for the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted regarding the present application filed on 30 October 2025, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: electrode 142, mentioned in [0116] of the specification as filed. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: element 930, shown in Figures 9 and 10; element 1800, shown in Figures 18A and 18B; element 2010, shown in Figure 20; elements 2702 and 2704, shown in Figure 27A; elements 2715a and 2715b, shown in Figure 27C; element 2730, shown in Figure 27D; and element 3110, show in Figures 31A & B. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 175-204 are 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.
Independent claim 175 recites, “… wherein the working electrode comprising a first electrode material comprising a roughened surface …” Independent claim 184 recites, “… wherein the first working electrode comprising a first electrode material comprising a roughened surface …” Independent claim 191 recites, “… the working electrode comprising a first electrode material comprising a roughened surface …” Independent claim 199 recites, “… wherein the first working electrode comprising a first electrode material comprising a roughened surface …” However, the instant specification only supports the working electrode having an electrochemically roughened surface, i.e., recitation at [0150] of the specification as filed: “In some variations, the working electrode surface may be electrochemically roughened …” Thus, as the broadest reasonable interpretation of “electrode material comprising a roughened surface” would include all types of roughening techniques, each of claims 175, 184, 191 and 199 do not comply with the written description requirement. That the interpretation includes all types of roughening techniques are include in each of the independent claims, is that each claim directly following each independent claim further limits the roughening to electrochemically roughened surfaces (see claims 176, 185, 192 and 200). As all the dependent claims ultimately depend from one of the rejected independent claims, they are likewise rejected for failing to comply with the written description requirement of 35 USC 112(a).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 175, 177-184, 186-191, 193-199 and 201-204 are rejected under 35 U.S.C. 103 as being unpatentable over a US Patent Application Publication to Wang, et al. (US 2022/0361776 A1; hereinafter, “Wang”) in view of a US Patent Application Publication to Fleming, et al. (US 2003/0135161 A1; hereinafter, “Fleming”).
Regarding claim 175, Wang discloses a microneedle array for use in sensing an analyte (Abstract: “… an array of hollowed needles, each hollowed needle having a protruded needle structure including multiple layers forming a hollow interior, at least one hollowed needle including a working electrode to interact with one or more chemical or biological substances that come in contact with the protruded needle structure …”), comprising:
a first microneedle comprising a working electrode ([0031]: “… working electrode (WE) …”),
wherein the working electrode comprises a first electrode material ([0031]: “… packed with graphite powder (GP)/ionic liquid (IL)/phenanthroline dione (PD)” …”)
a second microneedle comprising a counter electrode, wherein the counter electrode comprises a second electrode material ([0031]: “… another GP/MO packed microneedle acting as counter electrode (CE).”); and
a third microneedle comprising a reference electrode, wherein the reference electrode comprises a third electrode material and a redox-couple layer ([0031]: “An Ag/AgCl wire (500 μm)-integrated microneedle acts as a reference electrode (RE).”),
wherein a redox reaction occurs between the working electrode on the first microneedle and the counter electrode on the second microneedle ([00031]: “… the dual-analyte amperometric detection mechanism on multilayer modified sensors for HB (left) …”).
Wang does not teach a working electrode with a roughened surface.
However, Fleming discloses microneedle devices (Title), wherein is taught roughened microneedles ([0072]: “… the various features of the microneedle devices may have surfaces that are not smooth, e.g., the surfaces may be roughened …”).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have adapted the roughened microneedle surface, taught by Fleming, to the device disclosed by Wang, as it would enhance fluid flow over the surface (Fleming, [0072]).
Regarding claim 177, Wang teaches
β
-hydroxybutyrate dehydrogenase (HBD), NAD+ (nicotinamide adenine dinucleotide, oxidized form), or glutaraldehyde (GA). The HBD, NAD+, and/or GA can be configured in a layer partially or fully attached to the WE base layer, e.g. the IL-CP-PD electrode structure or layer ([0035]).
Regarding claims 178 and 179, Wang teaches the counter electrode is a GP/MO packed microneedle ([0031]).
Wang does not teach the surface of the second electrode material is a roughened surface.
However, Fleming discloses microneedle devices (Title), wherein is taught roughened microneedles ([0072]: “… the various features of the microneedle devices may have surfaces that are not smooth, e.g., the surfaces may be roughened …”).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have adapted the roughened microneedle surface, taught by Fleming, to the device disclosed by Wang, as it would enhance fluid flow over the surface (Fleming, [0072]).
Regarding claim 180, Wang does not teach the third electrode material comprises a roughened surface.
However, Fleming discloses microneedle devices (Title), wherein is taught roughened microneedles ([0072]: “… the various features of the microneedle devices may have surfaces that are not smooth, e.g., the surfaces may be roughened …”).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have adapted the roughened microneedle surface, taught by Fleming, to the device disclosed by Wang, as it would enhance fluid flow over the surface (Fleming, [0072]).
Regarding claims 181 and 182, Wang teaches both the working electrode and counter electrode comprise graphite powder (GP), a type of carbon ([0031]).
Regarding claim 183, Wang teaches the counter electrode comprises graphite powder (GP) ([0031]).
Regarding claim 184, Wang discloses a microneedle array for use in sensing an analyte (Abstract: “… an array of hollowed needles, each hollowed needle having a protruded needle structure including multiple layers forming a hollow interior, at least one hollowed needle including a working electrode to interact with one or more chemical or biological substances that come in contact with the protruded needle structure …”), comprising:
a first microneedle comprising a first working electrode,
wherein the first working electrode comprises a first electrode material
a second microneedle comprising a second working electrode, wherein the second working electrode comprises a second electrode material
a third microneedle comprising a counter electrode, wherein the counter electrode comprises a third electrode material 9[0031]: “… another GP/MO packed microneedle acting as counter electrode (CE).”),
wherein a first redox reaction occurs between the first working electrode on the first microneedle and the counter electrode on the third microneedle, and a second redox reaction occurs between the second working electrode on the second microneedle and the counter electrode on the third microneedle ([0031]: “… the schematic illustration of the dual-analyte amperometric detection mechanism on multilayer modified sensors for HB (left) and GL (right).”).
Wang does not teach the surface of the second electrode material is a roughened surface.
However, Fleming discloses microneedle devices (Title), wherein is taught roughened microneedles ([0072]: “… the various features of the microneedle devices may have surfaces that are not smooth, e.g., the surfaces may be roughened …”).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have adapted the roughened microneedle surface, taught by Fleming, to the device disclosed by Wang, as it would enhance fluid flow over the surface (Fleming, [0072]).
Regarding claim 186, Wang teaches
β
-hydroxybutyrate dehydrogenase (HBD), NAD+ (nicotinamide adenine dinucleotide, oxidized form), or glutaraldehyde (GA). The HBD, NAD+, and/or GA can be configured in a layer partially or fully attached to the WE base layer, e.g. the IL-CP-PD electrode structure or layer ([0035]).
Regarding claim 187, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04 VI B).
Regarding claim 188, Wang teaches a fifth microneedle comprising a reference electrode, wherein the reference electrode comprises a fifth electrode material and a redox-couple layer ([0031]: “An Ag/AgCl wire (500 μm)-integrated microneedle acts as a reference electrode (RE).”).
Regarding claim 189, Wang teaches both working electrodes comprise graphite powder (GP) ([0031]).
Regarding claim 190, Wang teaches both working electrodes and the counter electrode comprise graphite powder (GP) ([0031]).
Regarding claim 191, the shared limitations with instant claim 175 are taught by Wang in view of Fleming, as outlined above.
Wang teaches applying a bias potential and measuring a current value proportional to the concentration of the analyte by performing amperometric detection ([0031]).
Regarding claim 193, Wang teaches
β
-hydroxybutyrate dehydrogenase (HBD), NAD+ (nicotinamide adenine dinucleotide, oxidized form), or glutaraldehyde (GA). The HBD, NAD+, and/or GA can be configured in a layer partially or fully attached to the WE base layer, e.g. the IL-CP-PD electrode structure or layer ([0035]).
Regarding claims 194 and195, Wang teaches the counter electrode is a GP/MO packed microneedle ([0031]).
Wang does not teach the surface of the second electrode material is a roughened surface.
However, Fleming discloses microneedle devices (Title), wherein is taught roughened microneedles ([0072]: “… the various features of the microneedle devices may have surfaces that are not smooth, e.g., the surfaces may be roughened …”).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have adapted the roughened microneedle surface, taught by Fleming, to the device disclosed by Wang, as it would enhance fluid flow over the surface (Fleming, [0072]).
Regarding claim 196, Wang teaches the second working electrode ([0031]).
Wang does not teach the surface of the second electrode material is a roughened surface.
However, Fleming discloses microneedle devices (Title), wherein is taught roughened microneedles ([0072]: “… the various features of the microneedle devices may have surfaces that are not smooth, e.g., the surfaces may be roughened …”).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have adapted the roughened microneedle surface, taught by Fleming, to the device disclosed by Wang, as it would enhance fluid flow over the surface (Fleming, [0072]).
Regarding claim 197, Wang teaches both working electrodes and the counter electrode comprise graphite powder (GP) ([0031]).
Regarding claim 198, Wang teaches the counter electrode comprises graphite powder (GP) ([0031]).
Regarding claim 199, Wang in view of Fleming teaches the shared limitations with instant claim 184. Further, Wang teaches applying bias potentials and measuring current values proportional to analyte concentration by performing amperometric detection ([0031]).
Regarding claim 201, Wang teaches
β
-hydroxybutyrate dehydrogenase (HBD), NAD+ (nicotinamide adenine dinucleotide, oxidized form), or glutaraldehyde (GA). The HBD, NAD+, and/or GA can be configured in a layer partially or fully attached to the WE base layer, e.g. the IL-CP-PD electrode structure or layer ([0035]).
Regarding claims 202 and 203, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04 VI B).
Regarding claim 204, Wang teaches the working electrodes and counter electrode are fabricated using graphite powder (GP) ([0031]).
Claims 176, 185, 192 and 200 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Fleming as applied to claims 175, 184, 191, and 199 above, and further in view of a published paper by G. Cui, et al. (“Effect of pre-treatment on the surface and electrochemical properties of screen-printed carbon paste electrodes”, Analyst, 126(8): p. 1399-1403, July 2001; hereinafter, “Cui”).
Regarding claim 176, 185, 192 and 200, Wang in view of Fleming teaches the limitations of instant claims 175, 184, 191, and 199, as outlined above.
Wang nor Fleming teach electrochemical roughening of electrodes.
However Cui discloses the effect of various electrochemical pre-treatment methods on the surface and electrochemical properties of screen-printed carbon paste electrodes (SPCE) (Abstract), wherein is taught short pre-anodization (30 s–3 min in the +1.5 to +2.0 V range) of SPCE based on two different commercial carbon inks in phosphate buffer solution (0.05 M) appeared to increase their surface functionalities and roughness or remove surface contaminants in a manner analogous to activation of other carbon electrodes (2nd ¶, Introduction, p. 1399).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have utilized the pre-anodization regiment taught by Cui as the roughening process disclosed in the combination of Wang and Fleming as the pre-anodization results in enhanced electrochemical activity for a variety of irreversible and quasi-reversible redox systems (Cui, 2nd ¶, Introduction, p. 1399).
Interview with the Examiner
If at any point during the prosecution it is believe an interview with the Examiner would further the prosecution of an application, please consider this option.
The Automated Interview Request form (AIR) is available to request an interview to be scheduled with the Examiner. First, an authorization for internet communications regarding the case should be filed prior or with an AIR online request.
The internet communication authorization form (SB/0439), which authorizes or withdraws authorization for internet-based communication (e.g., video conferencing, email, etc.) for the application must be signed by the applicant or the attorney/agent for applicant. The form can be found at:
https://www.uspto.gov/sites/default/files/documents/sb0439.pdf
The AIR form can be filled out online, and is automatically forwarded to the Examiner, who will call to confirm a requested time and date, or set up a mutually convenient time for the interview. The form can be found at:
https://www.uspto.gov/patent/uspto-automated-interview-request-air-form.html
The Examiner encourages, but does not require, interviews by the USPTO Microsoft Teams video conferencing. This system allows for file-sharing along audio conferencing. Microsoft Teams can be used as an internet browser add-on in Microsoft IE, Google Chrome, or Mozilla Foxfire, or as a temporary Java-based application on these browsers. Steps for joining an Examiner setup Microsoft Teams can be found at the USPTO website:
https://www.uspto.gov/patents/laws/interview-practice#step3
Additionally, a blank email to the Examiner at the time of a telephonic interview can be used for a reply to easily allow for Microsoft Teams communication. Please note, policy guidelines regarding Internet communications are detailed at MPEP §500-502.3, and office policy regarding interviews are detailed at MPEP §713.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN C BALL whose telephone number is (571)270-5119. The examiner can normally be reached M - F, 9 am - 5:30 pm.
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/J. Christopher Ball/ Primary Examiner, Art Unit 1795