DETAILED CORRESPONDENCE
Summary
This Office Action is based on the Amendment and Response filed with the Office on 25 August 2026, regarding the Abeyrathne, et al. application.
Claims 2-21 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 .
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 2, 3, 5-13, and 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over a US Patent to Pace (US 4,454,007; hereinafter, “Pace”) in view of a published paper by A. Moya, et al. (“Flexible Microfluidic Bio-Lab-on-a-Chip Multi-Sensor Platform for Electrochemical Measurements”, SENSORS, 2014 IEEE, pp. 1018-1021, 2014, hereinafter, “Moya”).
Regarding claim 2, Pace discloses ion-selective layered sensor and methods of making and using the same (Title; which reads upon the instantly claimed, "[a]n ion sensor”).
Pace teaches a substrate (1) which may be ceramic (Col. 11, lines 2-3) or polyester film (Col. 8, lines 20-22; which reads on "a substrate comprising a non-conductive material”).
Pace further teaches an indicator half cell (4) comprising an ionophoric layer (9; Col. 11, lines 32-34; reading upon "at least one ion selective electrode comprising an ion selective electrode material deposited on the substrate”).
Also, Pace teaches a reference half cell (4') comprising an ionophoric layer (9') of reference half cell is overlaid by salt bridge layer (11) and covered by a protective layer (13) which physically shields reference half cell from direct contact with analyte, wherein the salt bridge layer includes KCI (Col. 11, lines 39-42; Table 4; which reads upon the limitation, "a solid-state reference electrode, comprising: a reference electrode material deposited on the substrate; and a combination of a chloride-containing salt and a polymer deposited on the reference electrode material”).
Additionally, Pace teaches a topmost layer of the sensor is an overcoat layer, typically of silicon rubber, wherein this topmost layer covers the entire chip except for a small area which is left open to provide electrical contact between analyte solution contained in the receiving zone and the PVA/salt layer (Col. 9, lines 29-37; which reads upon "an insulating layer placed over the at least one ion selective electrode and the solid-state reference electrode …”). Pace further teaches analyte must over-lap the half cells sufficiently to establish ionic contact with both half cells. This area between the half cells constitutes a receiving zone for the analyte. Though it is not required, this zone may be given a dish-shaped or other type of configuration to define the zone and hold the liquid analyte in place more effectively. Thus, it would be obvious to one of ordinary skill in the art to have configured the receiving zone of Pace to be “at least one opening for the at least one ion selective electrode and at least one opening for the solid-state reference electrode”, as such a configuration would isolate the ion selective electrode from the solid-state reference electrode so that there would be electronic crosstalk between the electrodes.
Pace does not explicitly teach a microfluidic layer and a cover layer placed over the microfluidic layer, as required by instant claim 1.
Moya discloses a novel polymeric microfluidic multi-sensor system (Abstract), wherein is taught polyvinyl chloride (PVC) membranes were prepared for the development of H+, Na+ and K+ μISE (3rd ¶, B. Working electrodes preparation, p. 1020) which define of active area of the electrodes using PSA which defines the channel height of 180 μm and the width of 500 μm (Figure 1 c) and are housed in a PMMA holder (Figure 1d). These elements read upon the claimed "a microfluidic layer placed over the at least part of the insulating layer; and a cover layer placed over the microfluidic layer').
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 incorporated the microfluidic channel and cover taught by Moya into the sensor disclosed by Pace because it allows analyte detection of changes in real time, with rapid response, allowing measuring small volumes and fast cell metabolisms changes (Moya, Abstract).
Regarding claim 3, Moya teaches an input and output (Figure 1d).
Regarding claim 5, Pace teaches ionophores for potassium, sodium, calcium, chloride, bicarbonate, and nitrate (Col. 3, Table 1).
Regarding claims 6 and 7, Pace teaches components of an ionophoric layer (Table 4), wherein is taught as part of the layer valinomycin, a potassium ionophore (Table 4).
Regarding claim 8, Moya teaches multiple ISE sensors (Figure 3a).
Regarding claims 9 and 10, Pace teaches the reference element can itself consist of several layers such as a metal layer in contact with a soluble salt layer which, in tum, is in contact with a layer of electrolyte dissolved in a solid hydrophilic binder such as polyvinyl alcohol, agarose or deionized gelatin (Col. 2, lines 34-38).
Regarding claim 11, Pace teaches sensors compatible with whole blood (Col. 1, lines 21-25).
Regarding claim 12, Pace and Moya teach all the share limitations with instant claim 2. All taught elements would necessarily be provided.
Regarding claim 13, Moya teaches an input and output (Figure 1d).
Regarding claim 15, Pace teaches ionophores for potassium, sodium, calcium, chloride, bicarbonate, and nitrate (Col. 3, Table 1).
Regarding claims 16 and 17, Pace teaches components of an ionophoric layer (Table 4), wherein is taught as part of the layer valinomycin, a potassium ionophore (Table 4).
Regarding claim 18, Moya teaches multiple ISE sensors (Figure 3a).
Regarding claims 19 and 20, Pace teaches the reference element can itself consist of several layers such as a metal layer in contact with a soluble salt layer which, in tum, is in contact with a layer of electrolyte dissolved in a solid hydrophilic binder such as polyvinyl alcohol, agarose or deionized gelatin (Col. 2, lines 34-38).
Regarding claim 21, Pace teaches sensors compatible with whole blood (Col. 1, lines 21-25).
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Pace in view of Moya as applied to claims 2 and 12 above, and further in view of a US Patent Application Publication to Cha, et al. (US 2011/0032785 A1; hereinafter, “Cha”).
Regarding claims 4 and 14, Pace in view of Moya teaches the limitations of claims 2 and 12, as outlined above.
However, neither Pace nor Moya teach a filter material layer.
However, Cha discloses a miniaturized planar-type reference electrodes that can be used both in potentiometry, wherein is taught porous material such as cotton thread, glass fiber, cellulose nitrate, cellulose acetate, filter paper, or polymer-based porous membrane ([0001]).
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 incorporated the porous material into the sensor as it would alleviate contamination of the sensor by large entities, such as cells.
Response to Arguments
Applicant's arguments filed 25 August 2026, have been fully considered but they are not persuasive. Applicant argues that the Pace reference does not teach the separate openings for each of the ion selective electrode and solid-state reference electrode, as the now amended claims require. However, the rejection above has been modified to demonstrate Pace teaches an area between the half cells constitutes a receiving zone for the analyte, wherein this zone may be given a dish-shaped or other type of configuration to define the zone and hold the liquid analyte in place more effectively. It would be obvious to one of ordinary skill that separate openings for each of the claimed electrodes as such a configuration would be advantageous to prevent crosstalk between the electrodes and ensure more accurate measurements. Therefore, the arguments are not persuasive to allowability of the pending claims.
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
THIS ACTION IS MADE FINAL. 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 JOHN C BALL whose telephone number is (571)270-5119. The examiner can normally be reached M - F, 9 am - 5:30 pm.
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, Luan Van can be reached at (571)272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J. Christopher Ball/ Primary Examiner, Art Unit 1795
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