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 .
Drawings
The replacement drawing was received on April 23, 2024. This drawing is accepted.
Claim Objections
Claim 68 is objected to because of the following informality: in line 5 “and” should be moved to the end of line 8.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Note that dependent claims will have the deficiencies of base and intervening claims.
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.
Claims 7, 11, 12, 14, 15, 18, 19, 22, 57, and 74 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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:
a) claim 7 recites the limitation "the plurality of vias" in line 3. There is insufficient antecedent basis for this limitation in the claim;
b) claim 11 recites the limitation "the plurality of electrical traces" in line 1. There is insufficient antecedent basis for this limitation in the claim;
c) claim 12 recites the limitation "the plurality of electrical traces" in line 1. There is insufficient antecedent basis for this limitation in the claim;
d) claim 14 recites the limitation "the circle" in line 2. There is insufficient antecedent basis for this limitation in the claim;
e) claim 15 recites the limitation "the circle" in line 2. There is insufficient antecedent basis for this limitation in the claim;
f) claim 18 recites the limitation "the first insulating layer" in line 1. There is insufficient antecedent basis for this limitation in the claim;
g) claim 19 recites the limitation "the first insulating layer" in line 1. There is insufficient antecedent basis for this limitation in the claim;
h) claim 22 requires “. . . ., wherein the electrode contact grouping is arranged in an orientation neutral pattern. [italicizing by the Examiner]” Although Applicant’s Figures 42A-I and 43A-43D are said to illustrate an orientation neutral pattern1 it is not clear what the scope of this term (“orientation neutral”) is, especially as the electrode patterns appear to be oriented radially , which is not clearly neutral. If Applicant is being his own lexicographer, please heed MPEP 2173.05(a);
i) claim 57 recites the limitation " the auxiliary electrode and the supplementary electrode [italicizing by the Examiner]" in lines 7-8. There is insufficient antecedent basis for this limitation in the claim (note “at least one auxiliary electrode” and “at least one supplementary electrode” earlier in the claim);
j) claim 74 requires “a plurality of zigzag auxiliary electrode contacts arranged in auxiliary electrode contact columns on the bottom surface; [italicizing by the Examiner]” The scope of the phrase “contact columns” is indefinite. Although examples of such columns are said to be shown by 5273 in Figure 52F (see Applicant's pre-grant application publication (US 20240272116 A1) paragraphs [0464] and [0467]), it is not clear what the 5273 “columns” feature are supposed to be. As this phrase is unique to Applicant, if Applicant is being his own lexicographer, please heed MPEP2173.05(a); and
k) claim 74 requires “a plurality of working electrode contacts arranged in punctuated working electrode columns on the top surface; . . . . italicizing by the Examiner]” The scope of the phrase “ punctuated working electrode columns” is indefinite. Although examples of such columns are said to be shown by 5274 in Figure 52F (see Applicant's pre-grant application publication (US 20240272116 A1) paragraphs [0464] and [0465]), it is not clear what makes 5274 “punctuated” nor what the “columns” aspect are. As this phrase is unique to Applicant, if Applicant is being his own lexicographer, please heed MPEP2173.05(a).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 5, 8, 17, 18, 20, 21, and 68 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Xing Yang US 2005/0196776 A1 (hereafter “Yang”).
Addressing claim 1, Yang discloses a multi-well assay plate (10; see the title, Abstract, Figures 1A and 1B, and paragraph [0025]) including:
a top plate (substrate 12 in Figure 1A; paragraph [0025](“ The well plate 12, alternatively referred to as a top plate . . . .“)) having top plate opening defining wells of the multi-well assay plate arranged in a well pattern (see Figure 1A and paragraph [0025]), each well being defined by a well area (this feature inferred from Figure 1A, noting therein the circular zones 24);
a base plate (20) including a substrate having a top surface (the visible surface in Figure 1A upon which the zones 24 are indicated) and a bottom surface (the underside surface of 20 in Figure 1A), the top surface being mated to the top plate (this feature may be inferred from Figure 1B, which shows the layers of Figure 1A stacked together. Also, see the top portion of Figure 4, which shows 12 directly upon 20, and note the following in paragraph [0025], “ The well plate 12, alternatively referred to as a top plate or multi-well plate, can be attached to a substrate 20 using an adhesive layer 14.”); and
a plurality of well electrode structures (210a and 210b in Figure 2A; paragraph [0033]), each of the plurality of well electrode structures including:
an electrode grouping patterned on the top surface and having an auxiliary electrode (counter electrodes 240a and 240b; paragraphs [0034] and [0035]), a supplementary electrode2 (reference electrodes 230a and 230b; paragraphs [0034] and [0035]), and a plurality of working electrodes (working electrodes 220a-223a and 220b-223b; paragraphs [0034] and [0035]) electrically isolated from the auxiliary electrode, the supplementary electrode, and a remainder of the plurality of working electrodes (Figures 2A, 3C, and 4. Note that there is nothing to indicate that any of the working electrodes is connected to an auxiliary electrode or a supplementary electrode, nor would this typically be considered desirable in an electrochemical sensor); and
an electrode contact grouping (all contact pads 402 in Figure 4 taken together; paragraphs [0060] and [0061]) patterned on the bottom surface corresponding to the electrode grouping and including a plurality of electrode contacts (402) including a plurality of working electrode contacts electrically connected to corresponding working electrodes, an auxiliary electrode contact electrically connected to the auxiliary electrode
(Figure 4 and [0060]-[0063]) , and
a supplementary electrode contact electrically connected to the supplementary electrode (Figure 4 and [0060]-[0063]).
Addressing claim 2, for the additional limitation of this claim note the following, “[0065] In one embodiment, the analyzer 430 controls the multiplexer 420 to apply a potential across a particular working electrode and counter electrode pair on the sample array 10. Then, the analyzer 430 performs, for example, coulometry or amperometry to determine if the sample in the sample well hybridized with a polymer probe captured on the working electrode. [italicizing by the Examiner]” Also, see boxes 632 and 640 in Figure 6).
Addressing claim 4, the additional limitation of this claim is implied by the following,
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Addressing claim 5, for the additional limitation of this claim see Yang Figure 1A noting adhesive layer 14. See also the first sentence of paragraph [0090].
Addressing claim 8, the additional limitation of this claim may be inferred from Figures 3A-C, which show the auxiliary electrodes (counter electrodes) and the supplementary electrodes (reference electrodes) are each connected to a different multiplexer. See also Yang paragraphs [0049]-[0057]. Moreover, one of ordinary skill in the art would not connect a counter electrode to a reference electrode unless explicitly required to do so as the “reference” function of the reference electrode would be compromised.
Addressing claim 17, for the additional limitation of this claim see Yang Figure 1A noting adhesive layer 14. See also the first sentence of paragraph [0090].
Addressing claim 18, for the additional limitation of this claim see Yang Figure 1A noting adhesive layer 14. The Examiner is construing each circular opening as “a single exposure”. See also the first sentence of paragraph [0090].
Addressing claim 20, for the additional limitation of this claim see Yang paragraph [0131] (“The sample array 10 is shown configured with the dimensions of a standard 96 well plate. However, the sample array 10 need not be a 96 well plate, but can be an array of sample wells in a standard plate configuration, or a non-standard, custom array configuration. For example, the well plate 12 can include 16 wells, 24 wells, 48 wells, 96 wells, 384 wells, 1536 wells, or some other number of wells.”)
Addressing claim 21, for the additional limitation of this claim see Yang paragraph [0131] (“The sample array 10 is shown configured with the dimensions of a standard 96 well plate.”)
Addressing claim 68, Yang discloses a multi-well assay plate (10; see the title, Abstract, Figures 1A and 1B, and paragraph [0025]) including:
a top plate (substrate 12 in Figure 1A; paragraph [0025](“ The well plate 12, alternatively referred to as a top plate . . . .“)) having top plate opening defining wells of the multi-well assay plate arranged in a well pattern (see Figure 1A and paragraph [0025]), each well being defined by a well area (this feature inferred from Figure 1A, noting therein the circular zones 24);
a base plate (20) including a substrate having a top surface (the visible surface in Figure 1A upon which the zones 24 are indicated) and a bottom surface (the underside surface of 20 in Figure 1A), the top surface being mated to the top plate (this feature may be inferred from Figure 1B, which shows the layers of Figure 1A stacked together. Also, see the top portion of Figure 4, which shows 12 directly upon 20, and note the following in paragraph [0025], “ The well plate 12, alternatively referred to as a top plate or multi-well plate, can be attached to a substrate 20 using an adhesive layer 14.”); and
a plurality of well electrode structures (210a and 210b in Figure 2A; paragraph [0033]), each of the plurality of well electrode structures including: an electrode grouping patterned on the top surface and having at least one auxiliary electrode (counter electrodes 240a and 240b; paragraphs [0034] and [0035]) and at least one working electrode (working electrodes 220a-223a and 220b-223b; paragraphs [0034] and [0035]);
a plurality of working electrode contacts electrically connected to working electrodes and an auxiliary electrode contact electrically connected to the auxiliary electrode (Figure 4 and [0060]-[0063]).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Hee-Jin Yee US 5,672,256 (hereafter “Yee”).
Addressing claim 3, as a first matter Yang discloses all of the limitations of underlying claim 1. See the rejection of claim 1 under 35 U.S.C. 102(a)(2) above. Although Yang does not appear to disclose “. . . ., wherein multiple working electrodes of a selected electrode grouping are configured to be separately electrically energized…”, Yang does disclose working electrode multiplexer (322) and controller that together can be used to select any working electrode desired to be energized. See paragraph [0051]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have the working electrode multiplexer (322) and controller be able to have multiple working electrodes of a selected electrode grouping be configured to be separately electrically energized because then these multiple working electrodes may be used to increase the accuracy of a particular analyte measurement by providing replicate measurements that will be averaged to reduce statistical variations in the measurements. See, for example, Yee the title, Abstract, Figure 3, and col. 2:43 – col. 3:4.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Glezer et al. US 2007/0202538 A1 (hereafter “Glezer”).
Addressing claim 6, as a first matter Yang discloses all of the limitations of underlying claim 1. See the rejection of claim 1 under 35 U.S.C. 102(a)(2) above.
Yang further discloses that the electrode grouping is disposed within the well area and the electrode contact grouping is disposed outside of the well area (see
Figure 4). As for the claim 6 limitation, “. . . ., and wherein each of the plurality of well electrode structure further includes: a via grouping including a plurality of vias electrically connected to the plurality of electrode contacts and passing through the substrate…” the Examiner believes that this may be reasonably inferred from the top portion of Figure 4 as it shows the electrodes 210a being located on the top surface of base plate 20, and their respective contact pads 402 on the underside surface of the base plate. In any event, Glezer discloses a multi-well assay plate (see the Abstract, 700 in Figure 7, and paragraph [0099]) including:
a top plate (730 in Figure 7b; paragraph [0095], first sentence) having top plate opening defining wells of the multi-well assay plate arranged in a well pattern (Figure 7a and 7b, and paragraph [0099], noting assay wells 710; also see Figure 6 embodiment, noting the well array in plate top 610.), each well being defined by a well area (see Figure 6 and paragraph [0095], first sentence; and Figures 7a and 7b, and paragraph [0099], noting especially assay wells 710);
a base plate including a substrate (740 in Figures 7a and 7b; paragraph [0101]) having a top surface (in Figure 7b the surface exposed to the wells 710 and on which electrodes 714 and 718 are located) and a bottom surface (the surface side facing sealing layer 790), the top surface being mated to the top plate (this feature may be inferred from Figure 7b viewed alongside 7c, and from “[0101] FIG. 7b also shows plate bottom 740 which seals against plate top 730 and defines the bottom of assay wells 710. [italicizing by the Examiner]”); and
a plurality of well electrode structures (714 and 718; paragraph [0099]), each of the plurality of well electrode structures including:
an electrode grouping patterned on the top surface (this feature may be inferred from Figure 7b, with the electrode grouping being, as an example, those electrodes associated with the left well (710)) and having an auxiliary electrode (the Examine is construing counter electrode 718 (paragraph [0099]) as an auxiliary electrode), and a plurality of working electrodes (714) electrically isolated from the auxiliary electrode, and a remainder of the plurality of working electrodes (Figure 7b); and
an electrode contact grouping patterned on the bottom surface corresponding to the electrode grouping and including a plurality of electrode contacts (this electrode contact grouping may be inferred from Figure 7b, noting electrode contacts 780 and 785 (paragraph [0101]) including a plurality of working electrode contacts (780) electrically connected to corresponding working electrodes, an auxiliary electrode contact (785) electrically connected to the auxiliary electrode (Figure 7b and paragraph [0101]).
Glezer further discloses that the electrode grouping is disposed within the well area and the electrode contact grouping is disposed outside of the well area, and wherein each of the plurality of well electrode structure further includes: a via grouping including a plurality of vias electrically connected to the plurality of electrode contacts and passing through the substrate. See Glezer Figure 7b.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have the plurality of well electrode structure of Yang further include: a via grouping including a plurality of vias electrically connected to the plurality of electrode contacts and passing through the substrate, as taught by Glezer, because it is prima facie obvious as simple substitution of one known element (means for connecting electrodes on the top surface of a substrate to respective contact pads on the underside of the substrate) for another (whatever connecting means is contemplated by Yang) to obtain predictable results.
Claims 7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Fuller et al. US 2006/0216203 A1 (hereafter “Fuller”).
Addressing claim 7, as a first matter Yang discloses all of the limitations of underlying claim 1. See the rejection of claim 1 under 35 U.S.C. 102(a)(2) above.
Yang does not disclose whether “each of the plurality of well electrode structure further includes an electrical trace grouping including a plurality of electrical traces patterned on the top surface and electrically connecting the plurality of vias to the electrode grouping. “
Fuller discloses a multiwell sample plate with integrated electrodes and a connection scheme. This connection scheme comprises each of a plurality of well electrode structure including an electrical trace grouping including a plurality of electrical traces patterned on the top surface of a substrate and electrically connecting a plurality of vias to the electrode grouping. See in Fuller the title, Figures 1-3 and 5-7, and paragraphs [0039], [0044], and [0045].
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide an electrical trace grouping as taught by Fuller in the plate of Yang because this is prima facie obvious as simple substitution of one known element (way of connecting electrodes on a top surface of a substrate of a multi-well assay plate to electrical contacts on the underside of the substrate) for another to obtain predictable results, especially as Yang does not provide any details on how the electrodes on the top surface of the substrate are to be connected to their respective electrical contacts on the underside of the substrate. See MPEP 2143(I)(B). Moreover, Fuller discloses the following benefits,
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Addressing claim 11, as a first matter Yang discloses all of the limitations of underlying claim 1. See the rejection of claim 1 under 35 U.S.C. 102(a)(2) above. Also, there is no antecedent basis for “the plurality of electrical traces”.
Yang does not disclose whether “the plurality of electrical traces provide electrical connection between the electrode contact grouping arranged outside of the well area to the electrode grouping arranged inside of the well area.”
Fuller discloses a multiwell sample plate with integrated electrodes and a connection scheme. This connection scheme comprises a plurality of electrical traces providing electrical connection between an electrode contact grouping arranged outside of the well area to an electrode grouping arranged inside of ta well area. See in Fuller the title, Figures 1-3 and 5-7, and paragraphs [0039], [0044], and [0045].
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide a plurality of electrical traces as taught by Fuller in the plate of Yang because this is prima facie obvious as simple substitution of one known element (way of connecting electrodes on a top surface of a substrate of a multi-well assay plate to electrical contacts on the underside of the substrate) for another to obtain predictable results, especially as Yang does not provide any details on how the electrodes on the top surface of eh substrate are to be connected to their respective electrical contacts on the underside of the substrate. See MPEP 2143(I)(B). Moreover, Fuller discloses the following benefits,
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Claims 9, 10, 13-15, 22-24, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Yang.
Addressing claim 9, as a first matter Yang discloses all of the limitations of underlying claim 1. See the rejection of claim 1 under 35 U.S.C. 102(a)(2) above.
Yang does not disclose :. . . ., wherein the supplementary electrode [reference electrode] is configured to partially surround the auxiliary electrode [counter electrode].” However, Yang Figure 2D shows the auxiliary electrode (290) in the form of a ring. Furthermore, although not shown in this figure, Yang discloses that it may also comprise a reference electrode (supplementary electrode)3. See Yang paragraph [0047], last three sentences. Barring evidence to the contrary, such as unexpected results, to have the reference electrode be in the form of an arc partially surrounding the auxiliary electrode in Yang Figure 2D, conforming to the curvature of the auxiliary electrode, is prima facie obvious as a change in shape of the reference electrode with no material effect on the operation of the reference electrode. See MPEP 2144.04(IV)(B).
Addressing claim 10, as a first matter Yang discloses all of the limitations of underlying claim 1. See the rejection of claim 1 under 35 U.S.C. 102(a)(2) above.
Yang does not disclose :. . . ., wherein the supplementary electrode [reference electrode] is configured with a border edge equidistant to a border edge of the auxiliary electrode [counter electrode].” However, Yang Figure 2D shows the auxiliary electrode (290) in the form of a ring. Furthermore, although not shown in this figure, Yang discloses that it may also comprise a reference electrode (supplementary electrode)4. See Yang paragraph [0047], last three sentences. Barring evidence to the contrary, such as unexpected results, to have the reference electrode be in the form of a concentric ring (so sharing the same center) inside or outside the auxiliary electrode in Yang Figure 2D, so having a border edge (its inner or outer circumference)(see annotated Yang Figure 2D below, at the end of this claim rejection), equidistant to a border edge of the auxiliary electrode , is prima facie obvious as a change in shape of the reference electrode with no material effect on the operation of the reference electrode. See MPEP 2144.04(IV)(B).
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Addressing claim 13, as a first matter Yang discloses all of the limitations of underlying claim 1. See the rejection of claim 1 under 35 U.S.C. 102(a)(2) above.
Although Yang does disclose wherein the auxiliary electrode is disposed at an approximate center of the well area (this may be inferred for Yang Figure 2A, noting the location of auxiliary electrode 240a), Yang does not disclose “the supplementary electrode is disposed to at least partially surround the auxiliary electrode, and the working electrodes are arranged in a circle approximately equidistant from the auxiliary electrode. However, to have the supplementary electrode (230a) be disposed as claimed is prima facie obvious as a change in shape with no material effect on the operation of this electrode (see annotated Yang Figure 2A at the end of this claim rejection), and to have the working electrodes (220a, 221a, 222a, 223a) be arranged as claimed is prima facie obvious as a rearrangement of parts with no material effect on the operation of these electrodes (see annotated Yang Figure 2A at the end of this claim rejection).
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Addressing claim 14, as a first matter Yang discloses all of the limitations of underlying claim 1. See the rejection of claim 1 under 35 U.S.C. 102(a)(2) above. Also, there is no antecedent basis for “the circle”.
Although Yang does not disclose that “the working electrodes are separated from each other in the circle by a plurality of working electrode spacings and at least one of the plurality of working electrode spacings is sized to permit the disposition therein of an auxiliary electrical trace of the plurality of electrical traces connecting the auxiliary electrode to the auxiliary electrode contact…”, to have the electrodes so configured is prima facie obvious as rearrangement of parts (the working electrodes (220a, 221a, 222a, 223a) ) with no material effect on the operation of these electrodes (see annotated Yang Figure 2A at the end of this claim rejection).
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Addressing claim 15, as a first matter Yang discloses all of the limitations of underlying claim 1. See the rejection of claim 1 under 35 U.S.C. 102(a)(2) above. Also, there is no antecedent basis for “the circle”.
Although Yang does not disclose that “the working electrodes are separated from each other in the circle by a plurality of working electrode spacings and at least one of the plurality of working electrode spacings is sized to permit the disposition therein of an supplementary electrical trace of the plurality of electrical traces connecting the supplementary electrode to the supplementary electrode contact…”, to have the electrodes so configured is prima facie obvious as rearrangement of parts (the supplementary electrode (230a) and the working electrodes (220a, 221a, 222a, 223a) ) with no material effect on the operation of these electrodes (see annotated Yang Figure 2A at the end of this claim rejection).
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Addressing claim 22, as a first matter Yang discloses all of the limitations of underlying claim 1. See the rejection of claim 1 under 35 U.S.C. 102(a)(2) above. Also, the scope of the term “neutral orientation” is not clear.
As the cope of “neutral orientation” is uncertain, the Examiner cannot determine whether Yang actually discloses this orientation for the electrode contact grouping. So, it will be assumed that Yang does not disclose the claimed neutral orientation. However, to have the electrode contact grouping be arranged in an orientation neutral pattern is prima facie obvious as rearrangement of parts with no material effect on the operation of the electrode contact grouping. See MPEP 2144.04(VI)(C) (Note: “In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice)”).
Addressing claim 23, as a first matter Yang discloses all of the limitations of underlying claim 1. See the rejection of claim 1 under 35 U.S.C. 102(a)(2) above. Although Yang does not explicitly disclose having the supplementary (reference) electrode be electrically connected to a second supplementary electrode in a neighboring well electrode structure, nevertheless, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have the supplementary electrode be electrically connected to a second supplementary electrode in a neighboring well electrode structure over Yang alone, as Yang does disclose, in one embodiment, coupling together electrodes from different well electrode structures, such as having a working electrode be electrically connected to a second working electrode in a neighboring well electrode structure in order to reduce the number of electrical connections at the connection interface. See Yang paragraph [0043]. As there is no supplementary electrode in the well electrode structures in this embodiment, one of ordinary skill in the art would recognize that if a supplementary electrode were to also included in the well electrode structures (see Yang paragraph [0039]), than having the supplementary (reference) electrode be electrically connected to a second supplementary electrode in a neighboring well electrode structure will also contribute to reducing the number of electrical connections at the connection interface.
.
Addressing claim 24, as a first matter Yang discloses all of the limitations of underlying claim 1. See the rejection of claim 1 under 35 U.S.C. 102(a)(2) above. Although Yang does not explicitly disclose having the auxiliary (counter) electrode be electrically connected to a second auxiliary electrode in a neighboring well electrode structure, nevertheless, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have the auxiliary electrode be electrically connected to an auxiliary supplementary electrode in a neighboring well electrode structure over Yang alone, as Yang does disclose, in one embodiment, coupling together electrodes from different well electrode structures, such as having a working electrode be electrically connected to a second working electrode in a neighboring well electrode structure in order to reduce the number of electrical connections at the connection interface. See Yang paragraph [0043]. One of ordinary skill in the art would recognize that electrically connecting the auxiliary electrode connected to a second auxiliary electrode in a neighboring well electrode structure will also contribute to reducing the number of electrical connections at the connection interface.
Addressing claim 26, Yang discloses a multi-well assay plate (10; see the title, Abstract, Figures 1A and 1B, and paragraph [0025]) including:
a plurality of wells (8; Figure 1A and paragraph [0025) arranged in a well pattern (Figure 1A);
a plurality of well electrode structures(210a and 210b in Figure 2A; paragraph [0033]) , each corresponding to a well of the plurality of wells (paragraph [0033], second and third sentences (“The electrode configuration can be implemented in the substrate 20 of FIGS. 1A-1B. A first set of electrodes 210a can be positioned in a zone, for example 8, on the substrate 20 within a first sample well. Similarly, a second set of electrodes 210b can be positioned on the substrate within a second zone aligned with a second sample well. [italicizing by the Examiner]“), each of the plurality of well electrode structures including: an electrode grouping patterned at a bottom of the well (this feature may be inferred form Figure 1A noting that the zones 24, which each contain an electrode grouping, is on substate 20, which is at the bottom of the layers to be assembled in a stack) and having an auxiliary electrode(counter electrodes 240a and 240b; paragraphs [0034] and [0035]) , a supplementary electrode a supplementary electrode5 (reference electrodes 230a and 230b; paragraphs [0034] and [0035]), and a plurality of working electrodes (working electrodes 220a-223a and 220b-223b; paragraphs [0034] and [0035]) electrically isolated from the auxiliary electrode and the supplementary electrode and a remainder of the plurality of working electrodes (Figures 2A, 3C, and 4. Note that there is nothing to indicate that any of the working electrodes is connected to an auxiliary electrode or a supplementary electrode, nor would this typically be considered desirable in an electrochemical sensor).
As for claim 26 limitation “the method including: generating a voltage potential between a selected working electrode and at least one of a selected auxiliary electrode and selected supplementary electrode associated with a selected well electrode structure; . . . .”, see paragraph [0068]].
As for the claim 26 limitation “the method including: . . . .; maintaining substantial electrical isolation of unenergized working electrodes of the selected well electrode structure; . . . .”, this step is implied by Yang paragraphs [0068] and [0070]:
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As for the claim 26 limitation “the method including: . . . .; and measuring a response to the voltage potential…”, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to perform this step because one of ordinary skill in the art would understand that this is the function of Analyzer 430 in Figure 4 and Electrochem Analyzer 540 in Figure 5. For example,
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Claims 19, 25, and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Glezer et al. US 2005/0142033 A1 (hereafter “Glezer II”).
Addressing claim 19, as a first matter Yang discloses all of the limitations of underlying claim 1. See the rejection of claim 1 under 35 U.S.C. 102(a)(2) above.
In Yang the first insulating layer (14) is configured to provide a single exposure that exposes the auxiliary electrode and the supplementary electrode. See the rejection of claim 18 under 35 U.S.C. 102(a)(2) above.
Glezer II disclose several embodiments of multi-well assay plates. These plates include a top plate (for example, 1302 in Figure 13a, 1402 in Figure 14a) having top plate opening defining wells (1309, 1403) of the multi-well assay plate arranged in a well pattern (Figures 13A and 14A), each well being defined by a well area (defined by 1310 in Figure 13a and by the holes in 1404 of Figure 14A. Also note “Well Area” in Figure 14A(B)); a base plate (1308, 1410) including a substrate having a top surface and a bottom surface (this may be inferred form Figures 13A and 14A), the top surface being mated to the top plate (this may be inferred from paragraph [0368], which states, “In use, components 502, 504, 506 and 508 of plate 500 should be sealed against adjoining layers so as to prevent the leakage of fluids contained within the wells of plate 500. Sealing may be accomplished by physically holding the components together under pressure through the use of fasteners and/or clamps. Such fasteners and/or clamps may be integrated into plate 500 and/or they may be comprised in an external fixture. Alternatively, Sealing may be accomplished through the use of adhesive coatings on the surface of the components. [italicizing by the Examiner]” One of ordinary skill in the art would assume the layers in Figure 13A and 14A and similarly to be held together.); and a plurality of well electrode structures , each of the plurality of well electrode structures including: an electrode grouping patterned on the top surface (note shown in Figure 13A, but implied as paragraph [0474] states, “FIG. 13A shows multiwall assay plate 1300, a plate analogous to multi-well assay plate 500 (as shown in FIG. 5) except that the pattern of holes 1312 through dielectric layer 1306 has been modified to define a plurality of fluid containment regions over the working electrode surface (i.e., first conductive layer 1308). [italicizing by the Examiner]” Presumably these electrodes could be patterned as shown in Figures 2A-D, 3A-C, and 4A-E. See paragraph [0150]. Likewise for electrode surface 1422 in Figure 14A. Also, note the following in paragraph [0193], “The assay modules of the present invention may use dielectric inks, films or other electrically insulating materials (hereinafter referred to as dielectrics). Dielectrics in the present invention may be used to prevent electrical connectivity between electrodes, to define patterned regions, to adhere materials together (i.e., as adhesives), to Support materials, to define assay domains, as masks, . . . .” [italicizing by the Examiner] ). See the title, Figures 13A and 14A, and paragraphs [0193] and [0474].
In light of Glezer II Figures 13A and 14A as just discussed, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide in the multi-well assay plate of Yang one or more dielectric layers as taught by Glezer II above the electrodes as appropriate to selectively expose the auxiliary electrode and the supplementary electrode by providing a first exposure that exposes the auxiliary electrode and a second exposure that exposes the supplementary electrode, and wherein the first exposure and the second exposure do not intersect, in order to “. . . .prevent electrical connectivity between electrodes, to define patterned regions, to adhere materials together (i.e., as adhesives), to support materials, [and] to define assay domains, as masks, . . . “, which are functions suggested by Glezer II for these dielectric layers. See Glezer II paragraph [0193].
Addressing claim 25, as a first matter Yang discloses all of the limitations of underlying claim 1. See the rejection of claim 1 under 35 U.S.C. 102(a)(2) above.
Yang does not disclose, “. . . ., wherein the multi-well assay plate is configured for use in an electrochemiluminescence (ECL) assay.” However, Yang does disclose the multi-well assay plate is configured for use in an electrochemical assay. See Yang the Abstract and paragraph [0003].
Glezer II disclose seal embodiments of multi-well assay plates. These plates include a top plate (for example, 1302 in Figure 13a, 1402 in Figure 14a) having top plate opening defining wells (1309, 1403) of the multi-well assay plate arranged in a well pattern (Figures 13A and 14A), each well being defined by a well area (defined by 1310 in Figure 13a and by the holes in 1404 of Figure 14A. Also note “Well Area” in Figure 14A(B)); a base plate (1308, 1410) including a substrate having a top surface and a bottom surface (this may be inferred form Figures 13A and 14A), the top surface being mated to the top plate (this may be inferred from paragraph [0368], which states, “In use, components 502, 504, 506 and 508 of plate 500 should be sealed against adjoining layers so as to prevent the leakage of fluids contained within the wells of plate 500. Sealing may be accomplished by physically holding the components together under pressure through the use of fasteners and/or clamps. Such fasteners and/or clamps may be integrated into plate 500 and/or they may be comprised in an external fixture. Alternatively, Sealing may be accomplished through the use of adhesive coatings on the surface of the components. [italicizing by the Examiner]” One of ordinary skill in the art would assume the layers in Figure 13A and 14A and similarly to be held together.); and a plurality of well electrode structures , each of the plurality of well electrode structures including: an electrode grouping patterned on the top surface (note shown in Figure 13A, but implied as paragraph [0474] states, “FIG. 13A shows multiwall assay plate 1300, a plate analogous to multi-well assay plate 500 (as shown in FIG. 5) except that the pattern of holes 1312 through dielectric layer 1306 has been modified to define a plurality of fluid containment regions over the working electrode surface (i.e., first conductive layer 1308). [italicizing by the Examiner]”
Glezer II further discloses that the multi-well assay plate is configured for use in an electrochemiluminescence (ECL) assay. See the Abstract and paragraphs [0006] and [0015]-[0019].
Drawing upon Glezer II, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to configure the multi-well assay plate of Yang for use in an electrochemiluminescence (ECL) assay because
(1) it would not require any significant change to the basic structural design of the multi-well assay plate of Yang (compare Yang Figure 1A with Glezer II Figure 5), only substitution, perhaps, of different materials or compositions for certain components in order to enable luminescence detection, for which Glezer II provides guidance (see, for example Glezer II paragraph [0136]);
(2) the electrochemical assay ability of the multi-well plate of Yang already provides the foundation for ECL assay (see Glezer II paragraph [0015], [0016], and [0102]); and
(3) Glezer II discloses, in paragraph [0007], “Commercially available ECL instruments have demonstrated exceptional performance. They have become
widely used for reasons including their excellent sensitivity, dynamic range, precision, and tolerance of complex sample matrices. [italicizing by the Examiner]”
Addressing claim 57, Yang discloses an electrochemical cell for performing electrochemical analysis (each of the wells 8 in Figure 1A form an electrochemical cell when the layers in Figure 1A are assembled. See the title and Abstract, and Figure 3C and 5 ) ,
the electrochemical cell including:
a plurality of working electrode zones disposed, and defining a pattern, on a surface of the cell (the Examine is construing, for example, each of working electrode 220a, 221a, 222a, and 223a along with the unlabeled working electrodes (open circles)6 in 210a of Figure 2A as forming the claimed plurality of working electrode zones );
at least one auxiliary electrode disposed on the surface (counter electrode 240a; paragraph [0034]); and
at least one supplementary electrode7 disposed on the surface (reference electrode 230a; paragraph [0034]), wherein each of the plurality of working electrode zones are electrically isolated from one another and from the auxiliary electrode and the supplementary electrode (this feature is implied by Yang paragraphs [0068] and [0070]:
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Although, the Examiner views Yang as disclosing “. . ., wherein each of the plurality of working electrode zones are electrically isolated from one another and from the auxiliary electrode and the supplementary electrode…”, alternatively, Glezer II disclose several embodiments of multi-well assay plates. These plates include a top plate (for example, 1302 in Figure 13a, 1402 in Figure 14a) having top plate opening defining wells (1309, 1403) of the multi-well assay plate arranged in a well pattern (Figures 13A and 14A), each well being defined by a well area (defined by 1310 in Figure 13a and by the holes in 1404 of Figure 14A. Also note “Well Area” in Figure 14A(B)); a base plate (1308, 1410) including a substrate having a top surface and a bottom surface (this may be inferred form Figures 13A and 14A), the top surface being mated to the top plate (this may be inferred from paragraph [0368], which states, “In use, components 502, 504, 506 and 508 of plate 500 should be sealed against adjoining layers so as to prevent the leakage of fluids contained within the wells of plate 500. Sealing may be accomplished by physically holding the components together under pressure through the use of fasteners and/or clamps. Such fasteners and/or clamps may be integrated into plate 500 and/or they may be comprised in an external fixture. Alternatively, Sealing may be accomplished through the use of adhesive coatings on the surface of the components. [italicizing by the Examiner]” One of ordinary skill in the art would assume the layers in Figure 13A and 14A and similarly to be held together.); and a plurality of well electrode structures , each of the plurality of well electrode structures including: an electrode grouping patterned on the top surface (note shown in Figure 13A, but implied as paragraph [0474] states, “FIG. 13A shows multiwall assay plate 1300, a plate analogous to multi-well assay plate 500 (as shown in FIG. 5) except that the pattern of holes 1312 through dielectric layer 1306 has been modified to define a plurality of fluid containment regions over the working electrode surface (i.e., first conductive layer 1308). [italicizing by the Examiner]” Presumably these electrodes could be patterned as shown in Figures 2A-D, 3A-C, and 4A-E. See paragraph [0150]. Likewise for electrode surface 1422 in Figure 14A. Also, note the following in paragraph [0193], “The assay modules of the present invention may use dielectric inks, films or other electrically insulating materials (hereinafter referred to as dielectrics). Dielectrics in the present invention may be used to prevent electrical connectivity between electrodes, to define patterned regions, to adhere materials together (i.e., as adhesives), to Support materials, to define assay domains, as masks, . . . .” [italicizing by the Examiner] ). See the title, Figures 13A and 14A, and paragraphs [0193] and [0474].
In light of Glezer II Figures 13A and 14A as just discussed, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide in the multi-well assay plate of Yang one or more dielectric layers as taught by Glezer II above the electrodes as appropriate to selectively expose the auxiliary electrode and the supplementary electrode, in order to “. . . .prevent electrical connectivity between electrodes, to define patterned regions, to adhere materials together (i.e., as adhesives), to support materials, [and] to define assay domains, as masks, . . . “, which are functions suggested by Glezer II for these dielectric layers. See Glezer II paragraph [0193].
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Fuller and Glezer II.
Addressing claim 45, Yang discloses a multi-well assay plate (10; see the title, Abstract, Figures 1A and 1B, and paragraph [0025]) including:
a top plate (substrate 12 in Figure 1A; paragraph [0025](“ The well plate 12, alternatively referred to as a top plate . . . .“)) having top plate opening defining wells of the multi-well assay plate arranged in a well pattern (see Figure 1A and paragraph [0025]), each well being defined by a well area (this feature inferred from Figure 1A, noting therein the circular zones 24);
a base plate (20) including a substrate having a top surface (the visible surface in Figure 1A upon which the zones 24 are indicated) and a bottom surface (the underside surface of 20 in Figure 1A), the top surface being mated to the top plate (this feature may be inferred from Figure 1B, which shows the layers of Figure 1A stacked together. Also, see the top portion of Figure 4, which shows 12 directly upon 20, and note the following in paragraph [0025], “ The well plate 12, alternatively referred to as a top plate or multi-well plate, can be attached to a substrate 20 using an adhesive layer 14.”); and
a plurality of well electrode structures (210a and 210b in Figure 2A; paragraph [0033]), each of the plurality of well electrode structures including:
an electrode grouping patterned on the top surface and having an auxiliary electrode (counter electrodes 240a and 240b; paragraphs [0034] and [0035]), a supplementary electrode8 (reference electrodes 230a and 230b; paragraphs [0034] and [0035]), and a plurality of working electrodes (working electrodes 220a-223a and 220b-223b; paragraphs [0034] and [0035]) electrically isolated from the auxiliary electrode, the supplementary electrode, and a remainder of the plurality of working electrodes (Figures 2A, 3C, and 4. Note that there is nothing to indicate that any of the working electrodes is connected to an auxiliary electrode or a supplementary electrode, nor would t