DETAILED ACTION
Response to Amendment
This is a final office action in response to a communication filed on October 20, 2025. Claims 1 and 3-20 are pending in the application.
Status of Objections and Rejections
All objections and rejections from the previous office action are withdrawn in view of Applicant’s amendment.
The rejection of claim 2 is obviated by Applicant’s cancellation.
New grounds of rejection under 35 U.S.C. §103 are necessitated by the amendments.
Claim Interpretation
Based on Applicant’s response and claim amendments, the claimed inventions are represented, as exemplified in Fig. 5c, that the working electrode is a three-dimensional electrode with a top surface, side surfaces, and the bottom surface. The membrane material deposited directly on the three-dimensional conductive surface of the working electrode, and the three-dimensional conductive surface as recited in claim 1 includes the top surface and the side surfaces of the working electrode. Since the membrane covers the three-dimensional conductive surface, it must be a three-dimensional membrane layer. Thus, for claim 1, the claimed “contours of the three-dimensional conductive surface” is the entire surface of the top surface and the side surfaces. For claim 8, the claimed “plurality of surfaces” includes the top surface and the side surfaces. The three-dimensional conductive surface or the plurality of surfaces is not in contact with the substrate because there is a passivation layer between the bottom surface of the working electrode and the substrate (e.g., Fig. 5c).
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-5, 7-9, 11, 13-14, and 16-19 is/are rejected under 35 U.S.C. 102 as being anticipated by Occhipinti (GB 2539224A).
Regarding claim 1, Occhipinti teaches a sensor (Fig. 1: 100) comprising:
a substrate (Fig. 1; p. 15, para. 2: substrate 1);
a patterned three-dimensional working electrode deposited on the substrate (Fig. 1; p. 15, para. 2: each of the conductive areas 2, 3, 4, 5), said patterned three-dimensional working electrode having a three-dimensional conductive surface (Fig. 1: each of the conductive areas 2, 3, 4, 5 has a three-dimensional conductive surface including its top surface and side surfaces); and
a membrane material (e.g., p. 18, para 2: the sensing layer 6 is composed by a thin layer of paralene C; p. 19, para. 6: coating the surface of the electrodes with a given functional membrane material containing the specific enzyme to govern the reaction to take place at the corresponding working electrode; thus, the sensing layer containing the specific enzyme is a membrane material) deposited directly on the three-dimensional working surface of the patterned three-dimensional working electrode (Fig. 1b, Fig. 2b; p. 15, para. 2: sensitive layers 6, 7, 8, and 9 on the conductive areas 2, 3, 4, 5) and not on the planar substrate (Fig. 1b; p. 15, para. 4: a thin adhesive layer interposed between said metallic layer, i.e., the patterned conductive areas 2, 3, 4, 5, and the substrate), wherein said membrane material follows the contours of the three-dimensional conductive surface to form a three-dimensional membrane layer that covers the three-dimensional conductive surface of the patterned three-dimensional working electrode (Fig. 2b: indicating the membrane, e.g., the pH sensing layer, is a three-dimensional membrane layer that covers the three-dimensional conductive surface including the top surface and the side surfaces of the pH working electrode).
Regarding claim 3, Occhipinti teaches wherein the membrane material (p. 19, para. 6: coating the surface of the electrodes with a given functional membrane material containing the specific enzyme to govern the reaction to take place at the corresponding working electrode; thus, the sensing layer containing the specific enzyme is a membrane material) is comprised of an analyte-selective membrane material (Fig. 9; p. 24, para. 4: the current signal generated by assessing amperometrically the hydrogen ions produced through the pH sensing layer 6; thus the pH sensing layer 6 is an analyte-selective material, i.e., selective to hydrogen ions).
Regarding claim 4, Occhipinti teaches wherein the membrane material is comprised of an ion-selective membrane material (Fig. 9; p. 24, para. 4: the current signal generated by assessing amperometrically the hydrogen ions produced through the pH sensing layer 6; thus the pH sensing layer 6 is an analyte-selective material, i.e., selective to hydrogen ions).
Regarding claim 5, Occhipinti teaches wherein the substrate is patterned, and the patterned three-dimensional working electrode is deposited in the patterned area of the substrate, forming a three-dimensional working electrode having one conductive surface (Fig. 2: indicating the working electrode having one conductive surface including the top and side surfaces on the patterned substrate; bridge para. between pp. 15-16: these patterned conductive areas can be formed by photolithographic technique; a layer of Platinum or gold is deposited on the substrate).
Regarding claim 7, Occhipinti teaches wherein the membrane material is biocompatible (p. 18, para. 2: the sensing layer 6 is composed by a pH sensitive biocompatible material).
Regarding claim 8, Occhipinti teaches a sensor (Fig. 2: 101), comprising:
a substrate (Fig. 2: substrate 1);
a first patterned, three-dimensional working electrode deposited on the substrate (Fig. 2b; p. 18, para. 2: electrodes 2, 3, 4; here the electrode 2 reads on a first patterned, three-dimensional working electrode), the three-dimensional working electrode having a plurality of surfaces (Fig. 2b: indicating the electrode 2 having a plurality surfaces, e.g., top surface and side surfaces), wherein said plurality of surfaces are not in contact with the substrate (Fig. 1b; p. 15, para. 4: a thin adhesive layer interposed between said metallic layer, i.e., the patterned conductive areas 2, 3, 4, 5, and the substrate);
a reference electrode deposited on the substrate (Fig. 2b; p. 21, para. 2: the reference electrode composed by the layer 9 on conductive electrode 5); and
a first membrane layer (Fig. 2b; p. 18, para. 2: the sensing layer 6; p. 19, para. 6: coating the surface of the electrodes with a given functional membrane material containing the specific enzyme to govern the reaction to take place at the corresponding working electrode; thus, the sensing layer containing the specific enzyme is a membrane layer), wherein said membrane layer is deposited directly on the plurality of surfaces of the first three-dimensional working electrode and not on the substrate (Fig. 2b; p. 18, para. 2: the sensing layer is directly deposited on the electrode 2 covering its top and the side surfaces; since there is a thin adhesive layer interposed between said metallic layer, e.g., the patterned conductive area 2, and the substrate, the membrane layer is not on the substrate).
Regarding claim 9, Occhipinti teaches wherein the membrane layer is not deposited on the reference electrode (Fig. 2b: indicating the membrane layer, i.e., the pH sensing layer 6 is not on the electrode 5; p. 21, para. 2: the layer 9 is composed by a silver electrode on top of a conductive electrode layer 5).
Regarding claim 11, Occhipinti teaches the sensor further comprising:
a second patterned, three-dimensional working electrode deposited on the substrate (Fig. 2b: e.g., electrode 4), the second three-dimensional working electrode having a second plurality of surfaces (Fig. 2b: electrode 4 having a top surface and side surfaces), wherein said second plurality of surfaces are not in contact with the substrate (Fig. 2b; p. 15, para. 4: a thin adhesive layer interposed between said metallic layer and the substrate); and
a second membrane layer (Fig. 2b: e.g., either pH sensing layer 6 or enzymatic membrane layer 8), wherein said second membrane layer is deposited on the plurality of surfaces of the second three-dimensional working electrode (Fig. 2b: indicating pH sensing layer 6 and enzymatic membrane layer 8 covering the surfaces of the electrode 4).
Regarding claim 13, Occhipinti teaches wherein the first membrane layer and the second membrane layer are selective for the same target (Fig. 2b: the pH sensing layer 6 on electrodes 2 and 4 are selective for the same target, i.e., hydrogen ions).
Regarding claim 14, Occhipinti teaches wherein the first membrane layer and the second membrane layer are selective for different targets (Fig. 2b; p. 23: the pH sensing layer 6 on electrode 2 and enzymatic membrane layer 8 on electrode 4 are selective for different targets, i.e., hydrogen ions and lactate).
Regarding claim 16, Occhipinti teaches a method of causing two-dimensional or three-dimensional transport (or increasing transport) of an ion through a membrane to a sensor surface (p. 11, para. 4: a method to read a signal corresponding to the concentration of the given substances, e.g., pH), the method comprising the steps of:
providing a sensor as described in claim 8 (as described in claim 8); and
exposing the membrane to a solution comprising the ion (p. 9, para. 2: able to detect the pH level of a solution; p. 10, para. 2: in order to limit the diffusion in the solution of protons to working electrode 2, a semipermeable membrane can be adopted; thus, the membrane is exposed to the solution for detecting pH level).
Regarding claim 17, Occhipinti teaches a method of determination an ion in a solution comprising the ion (p. 11, para. 4: a method to read a signal corresponding to the concentration of the given substances, e.g., pH), the method comprising the steps of:
providing a sensor as described in claim 8 (as described in claim 8);
exposing the membrane to the solution comprising the ion (p. 9, para. 2: able to detect the pH level of a solution; p. 10, para. 2: in order to limit the diffusion in the solution of protons to working electrode 2, a semipermeable membrane can be adopted; thus, the membrane is exposed to the solution for detecting pH level); and
electrochemically (p. 9, para. 2: an electrochemical sensor) determining a property of the ion, thereby determining the ion in the solution (p. 9, para. 2: to detect the pH level of a solution; here, the pH level is based on the concentration of the hydrogen ions).
Regarding claim 18, Occhipinti teaches wherein the determined property is the concentration of the ion in the solution (the pH level is based on the concentration of the hydrogen ions).
Regarding claim 19, Occhipinti teaches a method of determination an ion in a solution comprising the ion (p. 11, para. 4: a method to read a signal corresponding to the concentration of the given substances, e.g., pH), the method comprising the steps of:
providing a sensor as described in claim 1 (as described in claim 1);
exposing the membrane to the solution comprising the ion (p. 9, para. 2: able to detect the pH level of a solution; p. 10, para. 2: in order to limit the diffusion in the solution of protons to working electrode 2, a semipermeable membrane can be adopted; thus, the membrane is exposed to the solution for detecting pH level); and
electrochemically (p. 9, para. 2: an electrochemical sensor) determining a property of the ion, thereby determining the ion in the solution (p. 9, para. 2: to detect the pH level of a solution; here, the pH level is based on the concentration of the hydrogen ions).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Occhipinti in view of Morgan (US 2020/0268292).
Regarding claim 6, Occhipinti discloses all limitations of claim 1, but fails to teach wherein the patterned electrode comprises an interdigitated electrode structure.
However, Morgan teaches a pH sensor ([Abstract]) with various different types of electrode lay-out, e.g., disks, rings and interdigitated electrodes (¶82).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Occhipinti by substituting its electrode lay-out with the interdigitated one as taught by Morgan because interdigitated electrode provides a suitable electrode lay-out for pH sensors and the substitution of one known element for another would yield nothing more than predictable results. MPEP 2141(III)(B).
Claim(s) 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Occhipinti in view of Pepin (US 2016/0310050).
Regarding claim 10, Occhipinti discloses all limitations of claim 8, but fails to teach wherein the working electrode and the reference electrode are interdigitated.
However, Pepin teaches an eye-mountable device ([Abstract]), for example, in the form of a contact lens that includes a sensor configured to detect the at least one analyte (e.g., glucose) (¶2). The sensor can be an amperometric electrochemical sensor (¶38), and may take the form of a working electrode and a reference electrode in an interdigitated arrangement (¶78).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Occhipinti by substituting its working electrode and reference electrode with those in an interdigitated arrangement as taught by Pepin because interdigitated electrodes (WE and RE) are suitable for the electrode configuration of an electrochemical sensor. Here, the substitution of one known element for another would yield nothing more than predictable results. MPEP 2141(III)(B).
Regarding claim 12, Occhipinti discloses all limitations of claim 11, but fails to teach wherein the first, second, and reference electrodes are interdigitated.
However, Pepin teaches an eye-mountable device ([Abstract]), for example, in the form of a contact lens that includes a sensor configured to detect the at least one analyte (e.g., glucose) (¶2). The sensor can be an amperometric electrochemical sensor (¶38), and may take the form of a working electrode and a reference electrode in an interdigitated arrangement (¶78).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Occhipinti by substituting the first and second working electrodes and reference electrode with those in an interdigitated arrangement as taught by Pepin because interdigitated electrodes (WE1, WE2, and RE) are suitable for the electrode configuration of an electrochemical sensor. Here, the substitution of one known element for another would yield nothing more than predictable results. MPEP 2141(III)(B).
Claim(s) 15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Occhipinti in view of Petisee (US 2013/0199944).
Regarding claim 15, Occhipinti teaches a sensor (Fig. 1: 100), comprising:
a substrate having a first side and a second side (Fig. 1; p. 15, para. 2: substrate 1 having the top and the bottom sides);
a first patterned, three-dimensional working electrode deposited on the first side of the substrate (Fig. 1; p. 15, para. 2: each of the conductive areas 2, 3, 4, 5 on the top side of the substrate 1; here electrode 2 reads on a first patterned, three-dimensional working electrode), the three-dimensional working electrode having a plurality of surfaces (Fig. 1: each of the conductive areas 2, 3, 4, 5 has a top surface and side surfaces), wherein said plurality of surfaces are not in contact with the substrate (Fig. 1b; p. 15, para. 4: a thin adhesive layer interposed between said metallic layer, i.e., the patterned conductive areas 2, 3, 4, 5, and the substrate);
a first membrane layer (e.g., p. 18, para 2: the sensing layer 6 is composed by a thin layer of paralene C; p. 19, para. 6: coating the surface of the electrodes with a given functional membrane material containing the specific enzyme to govern the reaction to take place at the corresponding working electrode; thus, the sensing layer containing the specific enzyme is a membrane layer), said first membrane layer being deposited directly on the plurality of surfaces of the first three-dimensional working electrode and not on the substrate (Fig. 1: indicating each sensitive layer is three-dimensional and covers the top surfaces of each conductive area; p. 15, para. 2: sensitive layers 6, 7, 8, and 9 on top of conductive areas 2, 3, 4, 5; p. 15, para. 4: a thin adhesive layer interposed between said metallic layer and the substrate);
a second patterned, three-dimensional working electrode deposited on the substrate (Fig. 2b: electrode 4 on the top side of the substrate 1), the second three-dimensional working electrode having a second plurality of surfaces (Fig. 2b: electrode 4 having a top surface and side surfaces), wherein said second plurality of surfaces are not in contact with the substrate (Fig. 1b; p. 15, para. 4: a thin adhesive layer interposed between said metallic layer and the substrate);
a second membrane layer, said second membrane layer being deposited on the plurality of surfaces of the second three-dimensional working electrode (Fig. 2b: enzymatic membrane layer 8 covering the electrode 4);
and a reference electrode (Fig. 2b; p. 21, para. 2: the reference electrode composed by the layer 9 on conductive electrode 5), said reference electrode not being in contact with the first or second membrane layer (Fig. 2b: electrode 5 is not in contact with the pH sensing layer 6 or the enzymatic membrane layer 8).
Occhipinti does not disclose the sensor is double-sided and the second patterned, three-dimensional working electrode deposited on the second side of the substrate.
However, Petisee teaches a double-sided sensor (Fig. 3C), in which working electrode 12 and pH sensor 14 are disposed on opposite surfaces of the substrate 45 (Fig. 3C; ¶139).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Occhipinti by arranging the pH sensor and the working electrode on opposite sides of the substrate as taught by Petisee because the working electrode may be disposed on one surface of substrate while pH sensor is disposed on the opposing surface or pH sensor is disposed on the same surface of substrate 45 as working electrode (¶140). Thus, it would be prima facie obvious to substitute one known electrode configuration for another would yield nothing more than predictable results. MPEP 2141(III)(B). Further, the pH sensor would be disposed on the same or the opposite surfaces of the substrate as taught by Petisee (¶140), and choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is prima facie obvious. MPEP 2141(III)(E).
Regarding claim 20, Occhipinti teaches a method of determination an ion in a solution comprising the ion (p. 11, para. 4: a method to read a signal corresponding to the concentration of the given substances, e.g., pH), the method comprising the steps of:
providing a sensor as described in claim 15 (as described in claim 15);
exposing the membrane to the solution comprising the ion (p. 9, para. 2: able to detect the pH level of a solution; p. 10, para. 2: in order to limit the diffusion in the solution of protons to working electrode 2, a semipermeable membrane can be adopted; thus, the membrane is exposed to the solution for detecting pH level); and
electrochemically (p. 9, para. 2: an electrochemical sensor) determining a property of the ion, thereby determining the ion in the solution (p. 9, para. 2: to detect the pH level of a solution; here, the pH level is based on the concentration of the hydrogen ions).
Response to Arguments
Applicant’s arguments have been considered but are unpersuasive.
Applicant argues the sensitive layers 6, 7, 8, and 9 are not membrane layers and do not follow the contours of a three-dimensional electrode (Response, p. 7, last para.). This argument is unpersuasive because Occhipinti teaches coating the surface of the electrodes with a given functional membrane material containing the specific enzyme to govern the reaction to take place at the corresponding working electrode (p. 19, para. 6), for example, the sensing layer 6 is composed by a thin layer of paralene C (p. 18, para 2), and thus the sensing layer containing the specific enzyme is a membrane layer made of membrane material. Further, Fig. 2b explicitly indicates these sensing layers, i.e., membrane layers, covering both the top and side surfaces.
Applicant argues the membrane layer, at least its outer layers, of Occhipinti make contact with the substrate 1 at their edges (p. 8, para. 2). This argument is unpersuasive. Occhipinti also teaches a thin adhesive layer interposed between said metallic layer (e.g., Titanium or Chromium), i.e., the patterned conductive areas 2, 3, 4, 5 (e.g., Platinum or Gold), and the substrate (Fig. 1b; p. 15, para. 4). The substrate surface is cleaned and activated by oxygen plasma treatment before deposition of a thin adhesive layer, which is followed by a deposition of a subsequent layer of the patterned conductive areas (p. 16, para. 1, ll. 1-3). Thus, the adhesive layer covers the entire substrate surface, and the sensing layer, i.e., the membrane layer, coated on the patterned conductive areas, i.e., electrodes, would not in contact with the substrate.
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 extension fee 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.
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/C. SUN/Primary Examiner, Art Unit 1795