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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/10/2024 has been considered by the examiner.
Election/Restrictions
Applicant's election of Group I, claims 1-2, 5, 8-11, 14, and 17-20, without traverse in the reply filed on 10/30/2025 is acknowledged.
Claim Objection
Claims 1 and 8 are objected to because of the following informalities:
Claim 1: please amend “some of the pixels in the plurality ” to -- some of pixels --.
Claim 8: please amend “OCP” to – open circuit potential (OCP) --.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Regarding claim 10, claim 10 recites “the two-dimensional array”, which lacks antecedent basis. It is unclear if claim 10 depends from claim 9 which provides antecedent basis of the two-dimensional array. Thus, the scope of claim 10 is indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 5, 8-11, 14, and 17-20 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).
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 1, 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).
Conclusion
The prior arts made of record and not relied upon are considered pertinent to applicant's disclosure: Li (US20050252777A1) teaches a device as shown in Fig.5B comprising a CE 218 surrounded by a RE 220 and a plurality of working electrodes 216. Kavusi et al. (US20140008244A1) teaches modulation of pH or ionic concentration in a biosensor comprising an electrode array (claims 20, 28). Ebejer et al. (US20190336976A1) teaches pH control for analyte detection. Shin et al. (US20220018806A1) teaches closed-loop pH control wherein the device comprising a plural of pixels (Figs. 10-12) wherein each pixel comprises a working electrode, a sensing element for sensing pH and a counter electrode surrounding the working electrode (Fig.4E). Shin et al. (US20220268729A1) teaches closed-loop electrochemical pH modulation. Escoffier et al. (US20070034511A1) teaches a device as shown in Fig.5 comprising an annular WE surrounding an attachment zone Z, and an annular CE surrounding the WE, wherein pH in the region of the attachment zone Z is electrochemically controlled with the WE.
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.
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/SHIZHI QIAN/Examiner, Art Unit 1795