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 .
Status of the Claims
The Amendment filed June 29, 2026 has been entered. Claims 1, 8, and 10 have been amended; claims 46-47 are new; and claims 3-4, 6-7, 12-13, 15-16, and 21-45 have been cancelled. Claims 1-2, 5, 8-11, 14, 17-20 and 46-47 are currently pending and are examined herein.
Status of the Rejection
Applicant’s amendments to the Claims have overcome each objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed December 31, 2025.
All 35 U.S.C. § 103 rejections from the previous office action are maintained and modified only in response to the amendment as outlined below.
New grounds of rejection under 35 U.S.C. § 103 for new claims 46-47 are necessitated by the amendments as outlined below.
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.
Claims 1-2, 5, 8-11, 14, 17-20 and 46-47 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US20200363371A1).
Regarding claim 1, Johnson teaches a device (a device comprising a multi-electrode array as shown in Figs. 49 and 55 wherein each electrode set with a working, a sensing, and a counter electrode can be controlled independently for a distinctive target pH value and a temporal control scheme [para. 0185, 0388, 0398]), comprising:
a substrate comprising an integrated circuit (a substrate comprising a multi-electrode array as shown in Figs.49 and 55 [para. 0185, 0388, 0398]; a multi-electrode array with the feedback-controlling electrode sets distributed throughout the substrate [para. 0187]; see electrode set disposed on a “substrate” as shown in Fig. 54B) comprising a plurality of pixels (see Fig.49; each pixel in Fig.49 comprises a single device and Fig. 55 shows various designs such as the design of Fig.55E for each single device [para. 0398]),
wherein at least some pixels in the plurality of pixels comprise a first electrode (each pixel in Fig.49 comprises a single device and Fig. 55 shows various designs such as the design of Fig.55E for each single device; working electrode as shown in Fig.55E is deemed as the first electrode), a second electrode defining a second interior (counter electrode patterned around the working electrode as shown in Fig.55E defining a second interior [para. 0398]), and a pH sensor (sensing element in Fig.55E; the sensing element contains an electrode coated with a pH sensitive material [para. 0026]),
wherein the pH sensor is present within the second interior (Fig.55E shows the pH sensor [sensing element] is present within the second interior);
and one or more current injectors (current source 800 [para. 0376]);
and the limitation “wherein the first electrode and the second electrode of each of the at least some pixels are configured to independently receive current from the one or more current injectors” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Johnson teaches the device and methods iteratively select an amount of current and/or voltage to be applied to each working electrode, apply the selected amount of current and/or voltage to each working electrode to change pH of a solution close to the working electrode (abstract). The system is driven to apply a current from a current source 800 to increase the H+ concentration in solution 700 until the V in 830 detected by the SE 817 reaches a single OCP VTARGET value [para. 0376]. Where each electrode set with a working, a sensing, a reference, and a counter electrode can be controlled independently for a distinctive target pH value and a temporal control scheme [para. 0185]. Since a current is applied by the current source to the first electrode (which is the working electrode), the current flows between the working and counter electrodes to complete the closed electrical circuit. Thus, the first electrode (the working electrode) and the second electrode (the counter electrode) of each of the at least some pixels are configured to independently receive current from the one or more current injectors (the current source) to facilitate the change of pH [para. 0376].
Johnson does not explicitly teach wherein the first electrode (the working electrode in Fig.55E) defining a first interior, wherein the first interior is at least partially contained within the second interior.
Johnson does teach the sensing element needs physical separation from the working electrode to avoid crosstalk or shorting. If the working electrode and the sensing element need to be on the same plane, a small gap ranging from 1 nm to 100 microns can be used in between the working electrode and the sensing element, as shown in Fig.55C [para. 0398]. Fig.55C shows the working electrode and the sensing element are on the same plane, wherein the working electrode is patterned around the sensing element with a small gap between the working electrode and the sensing element.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrange the first electrode (working electrode) and the pH sensor (sensing element) on the same plane, wherein the working electrode surrounds the sensing element with a small gap between the working electrode and the sensing element, since Johnson teaches the suitable configuration of the working electrode and the sensing element to avoid crosstalk or shorting [para. 0398 and Fig.55C]. With the above modification, the first electrode defining a first interior wherein the sensing element is disposed within the first interior, and the first interior is at least partially contained within the second interior. Since the sensing element is disposed within the first interior, the sensing element (pH sensor) is present within both the first interior and the second interior.
Regarding claim 2, Johnson teaches the device of claim 1, and is silent to wherein an average pixel diameter is less than or equal to 100 micrometers.
Johnson further teaches when using an array of electrodes to locally control the microenvironment near each of the electrodes, “cross-talk” or “bleed-over” between different sites is a concern. This problem can be addressed through spacing out the individual sites [para. 0017]. Fig. 49 in Johnson shows as an average pixel diameter increases, with the same number of pixels and the same average interpixel spacing (since the interpixel spacing can’t be reduced due to the “cross-talk” problem [para. 0017]) on the device the size of the entire device increases, or with the same size of the entire device and the same average interpixel spacing the number of pixels decreases which reduces the density of the array (or the pixel density decreases). Thus, the average pixel diameter affects the size of the device and/or the pixel density of the device.
As the size and/or the pixel density of the device can be modified, among others, by adjusting an average pixel diameter, the precise average pixel diameter would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed average pixel diameter being less than or equal to 100 micrometers cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the average pixel diameter being less than or equal to 100 micrometers to provide the desired size and/or pixel density of the device to locally control the microenvironment near each of the electrodes. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 5, Johnson teaches the device of claim 1, and does not explicitly teach wherein an average interpixel spacing is less than or equal to 100 micrometers.
Johnson further teaches when using an array of electrodes to locally control the microenvironment near each of the electrodes, “cross-talk” or “bleed-over” between different sites is a concern. This problem is addressed either through spacing out the individual sites, or with a buffering reagent added to the bulk solution. The former approach results in the reduced density of the array (larger device size), and the latter requires that the rate of electrochemical reaction is high enough to overcome the buffering capacity of the bulk solution [para. 0017]. Thus, Johnson teaches the interpixel spacing affects “cross-talk” or “bleed-over” between different sites, thus is a result effective variable.
As the “cross-talk” or “bleed-over” between different sites can be modified, among others, by adjusting the average interpixel spacing through spacing out the individual sites (individual pixels), the precise average interpixel spacing would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed average interpixel spacing being less than or equal to 100 micrometers cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the average interpixel spacing being less than or equal to 100 micrometers to address the concern of “cross-talk” or “bleed-over” between different sites. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 8, Johnson teaches the device of claim 1, wherein the pH sensor is an open circuit potential (OCP) sensor (determining the pH of the solution based on the OCP of two or more electrodes in solution [para. 0310, 0327]; thus the pH sensor is an OCP sensor).
Regarding claim 9, Johnson teaches the device of claim 1, wherein the plurality of pixels is a two-dimensional array (Fig.49 shows wherein the plurality of pixels is a two-dimensional array).
Regarding claim 10, Johnson teaches the device of claim 9, and Fig. 49 shows wherein the two-dimensional array is a rectangular array instead of a square array.
However, changing from the disclosed rectangular array to the claimed square array basically changes the shape of the device from a rectangle to a square. The change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1976) (see MPEP § 2144.04). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the device from rectangle to square, and then accordingly rearrange the plurality of pixels to a square array in order to fit the square device. Rearrangement of parts where both arrangements are known equivalents is a design choice that gives predicable results [see MPEP 2144.04 (VI)].
Regarding claim 11, Johnson teaches the device of claim 1, and is silent to wherein a pixel density is greater than or equal to 100/mm2.
However, Johnson does teach when using an array of electrodes to locally control the microenvironment near each of the electrodes, “cross-talk” or “bleed-over” between different sites is a concern. This problem is addressed either through spacing out the individual sites, or with a buffering reagent added to the bulk solution. The former approach results in the reduced density of the array (larger device size), and the latter requires that the rate of electrochemical reaction is high enough to overcome the buffering capacity of the bulk solution [para. 0017]. Thus, Johnson teaches the density of the array (corresponding to the pixel density) affects the interpixel spacing, which affects “cross-talk” or “bleed-over” between different sites, thus the pixel density is a result effective variable.
As the “cross-talk” or “bleed-over” between different sites and the interpixel spacing can be modified, among others, by adjusting the pixel density, the precise pixel density would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed pixel density being greater than or equal to 100/mm2 cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the pixel density being greater than or equal to 100/mm2 to provide the desired interpixel spacing in order to address the concern of “cross-talk” or “bleed-over” between different sites. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 14, Johnson teaches the device of claim 1, and does not explicitly teach wherein a number of pixels in the plurality of pixels is greater than or equal to 200.
Johnson teaches wherein Fig.49 shows 7x14=98 pixels, and further teaches each set of electrodes can be programmed for specific pH conditions with temporal variations. The number of electrodes in an array can range from one to hundreds of millions [para. 0019].
It would have been obvious to have selected and utilized a number of pixels within the disclosed range, as taught by Johnson, including those amounts that overlap within the claimed range, since one of ordinary skill in the art would reasonably expect any value within the taught range to be suitable given that Johnson specifically teaches the range to be suitable for the number of electrodes in the array for varying pH at the different feedback-controlling electrode sets sites [para. 0241]. It has been held that obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05 (I).
Regarding claim 17, Johnson teaches the device of claim 1, wherein the first electrode is annular (Fig. 55E shows the working electrode is annular).
Regarding claim 18, Johnson teaches the device of claim 1, wherein the second electrode is annular (Fig. 55E shows the counter electrode is annular).
Regarding claim 19, Johnson teaches the device of claim 1, wherein the first electrode and the second electrode are concentric (Fig. 55E shows the working electrode and the counter electrode are concentric).
Regarding claim 20, Johnson teaches the device of claim 1, wherein a portion of the first interior is not a portion of the first electrode (As outlined in the rejection of claim 1 above, the working electrode and the sensing element are patterned on the same plane with a small gap between the working electrode and the sensing element, as shown in Fig.55C. Since the sensing element is disposed within the first interior, and the working electrode and the sensing element are separated by a small gap, a portion of the first interior is not a portion of the first electrode).
Regarding claim 46, Johnson teaches the device of claim 1, further comprising a second pH sensor (The electrical configuration can be composed of one or more working electrodes, pH sensing elements such as sensing electrodes [para. 0192]).
As outlined in the rejection of claim 1 above, Johnson teaches wherein the pH sensor is present within the first interior and the second interior.
Johnson is silent to wherein the second pH sensor is located outside of both the first interior and the second interior.
Since there are only three finite number of predictable results: (A) the second pH sensor is located inside both the first interior and the second interior; (B) the second pH sensor is located between the first interior and the second interior; and (C) the second pH sensor is located outside both the first interior and the second interior. Therefore, there is a finite number of identified, predictable solutions with a reasonable expectation of success. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try by choosing from the above finite number of identified solutions, which would lead to choose the solution (C): the second pH sensor is located outside both the first interior and the second interior. Choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 (I)(E)). Furthermore, since the pH sensor is already located inside both the first interior and the second interior to sense the pH in the region of inside both the first interior and the second interior, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the second pH sensor located outside both the first interior and the second interior to sense the pH in the region outside both the first interior and the second interior such that pH in regions of inside and outside of both the first interior and the second interior would be measured.
Regarding claim 47, Johnson teaches the device of claim 1, wherein the second interior contains a portion that is not a portion of the second electrode (Fig.55E shows the counter electrode defining the second interior, which contains a portion that contains the working electrode which is not a portion of the counter electrode).
Response to Arguments
Applicant's arguments, see Remarks Pgs. 5-8, filed 6/29/2026, with respect to the 35 U.S.C. § 103 rejections have been fully considered.
Applicant’s Argument #1:
Applicant argues at pages 5-7 that Johnson’s counter electrode is passive and shared among multiple working electrodes (see [para. 0185]), and it does not independently receive a current from a current injector or a voltage from a voltage stimulus source.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejection for claim 1 above. Johnson teaches where each electrode set with a working, a sensing, a reference, and a counter electrode can be controlled independently for a distinctive target pH value and a temporal control scheme [para. 0185]. Johnson further teaches a current source 800 configured to apply a current to the working electrode to facilitate the change of pH [para. 0376]. The applied current flows between the working and counter electrodes to complete the closed electrical circuit since the reference electrode, which provides a stable potential, draws virtually no current. Thus, the first electrode (the working electrode) and the second electrode (the counter electrode) is configured to independently receive current from the current source to facilitate the change of pH.
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 SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V Van can be reached on 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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/SHIZHI QIAN/Primary Examiner, Art Unit 1795
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