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 .
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 1-20 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 1 recites the limitation "the gate" in line 6. There is insufficient antecedent basis for this limitation in the claim. Note that there is a plurality of gates (“the plurality of detection units comprises a gate; . . . .”), so it is not clear which of these gates is “the gate”;
b) claim 5 requires “. . . ., wherein the gate, the source, and the drain are disposed on a same layer and made of a same material. [italicizing by the Examiner]” It is not clear how to interpret the additional limitation of this claim. Does it mean -- . . . ., wherein the biosensor further comprises a layer, and the gate, the source, and the drain are made of the same material and are all disposed on the layer…?
c) claim 6 requires “. . . ., wherein each of the plurality of detection units further comprises an insulative layer on a side, facing away from the base substrate, of the source and the drain, wherein the insulative layer is configured to wrap the source and the drain, . . . . [italicizing by the Examiner]” The additional limitation of claim 6 seems internally inconsistent as it is not clear how an insulative layer on a side of the source and the drain may also be configured to wrap (presumably substantially enclose) the source and the drain;
d) claim 12 recites the limitation "the gate" in line 8. There is insufficient antecedent basis for this limitation in the claim. Note that there is a plurality of gates (“the plurality of detection units comprises a gate; . . . .”), so it is not clear which of these gates is “the gate”;
e) claim 13 recites the limitation "the gate" in line 4. There is insufficient antecedent basis for this limitation in the claim. Note that there is a plurality of gates (“the plurality of detection units comprises a gate; . . . .”), so it is not clear which of these gates is “the gate”;
f) claim 19 requires “. . . ., wherein the gate, the source, and the drain are disposed on a same layer and made of a same material. [italicizing by the Examiner]” It is not clear how to interpret the additional limitation of this claim. Does it mean -- . . . ., wherein the biosensor further comprises a layer, and the gate, the source, and the drain are made of the same material and are all disposed on the layer…?
g) claim 20 requires “. . . ., wherein each of the plurality of detection units further comprises an insulative layer on a side, facing away from the base substrate, of the source and the drain, wherein the insulative layer is configured to wrap the source and the drain, . . . . [italicizing by the Examiner]” The additional limitation of claim 20 seems internally inconsistent as it is not clear how an insulative layer on a side of the source and the drain may also be configured to wrap (presumably substantially enclose) the source and the drain.
Allowable Subject Matter
Claims 1, 12, and 13 would be allowable if rewritten or amended to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 2-11 and 14-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
a) the combination of limitations in claim 1 requires the following underlined features
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Applicant’s as-filed specification paragraph [0062] discloses
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a)(i) the International Search Report for international application no. PCT/CN2023/072711 cites WO 2021240440 A1 and an article by Zou et al. as each being an “X” document against claims 1-15 of the international application. The corresponding Written Opinion, based on an English language translation obtained by the U.S. Examiner, deems claims 1-15 to have novelty, but lack an inventive step over the aforementioned “X” documents, which are referred to as D1 and D2, respectively. The rejection of claim 1 in the Written Opinion turns to D2, particularly its Figures 1 and 2, for “a plurality of recesses for accommodating a plurality of detection units”. However, in D2 the there is nothing to indicate that a separate recess would be provided for each detection unit in a Multi FET embodiment (Figure 4) and to do so is not possible for the Dual FET embodiment (Figure 4). Presumably the width and/or length of the recess in Figure 2(b) would be increased in order to accommodate a Multi FET (multi detection unit) sensor array chip, that is, a single chip on which there is an array of FET sensors. Additionally, the recess for the detection unit(s) is not in the cover plate, but in the base substrate. See Figure 2 and the brief description of Figure 2(b) on page 8. The designation cover plate and base substrate are not arbitrary here as sample (102) is loaded into an opening in the cover plate and the sensor is meant to be inserted into the meter (103) with the cover plate as the top plate. See Figures 1 and 2, the fourth full paragraph on page 12 (“The system provided . . . .”), and the third and fourth full paragraphs on page 13:
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a)(ii) Zantl et al. US 2010/0081189 A1 (hereafter “Zantl”) discloses a biosensor (see the title and paragraph [0001]), comprising:
a base substrate (bottom plate 107 (207)1; see paragraphs [0068] and [0074]);
a plurality of detection units (measurement electrodes 104 (204); see paragraphs [0067] and [0074]) disposed on a side of the base substrate (Figures 1 and 2);
a first drive signal line (conductor paths 103 (203); see paragraphs [0066] and [0074]) disposed on the side of the base substrate and electrically connected to the detection unit (Figures 1 and 2); and
a cover plate (106 (206); see paragraphs [0068] and [0074]) fixedly connected to the side of the base substrate (Figure 1 and the last sentence in paragraph [0071]), wherein a recess (109 (214); see paragraphs [0068] and [0074]) is defined in a side, proximal to the base substrate, of the cover plate (Figures 1 and 2).
Zantl, though, does not disclose “wherein each of the plurality of detection units comprises a gate; . . . .” and so does not also disclose “a first drive signal line disposed on the side of the base substrate and electrically connected to the gate; . . . . [italicizing by the Examiner]”
Even if it would be obvious to substitute several of measurement electrodes of Zantl with FET sensors as taught by Takatsuji et al.
JP 60251873 A, based on a J-Plat Pat machine-generated English language translation (hereafter “Takatsuji”) (see Figures 2 and 3, and Examples of the Invention on pages 3-4) or Khan et al., “An Integrated Microfluidic Platform for Selective and Real-Time Detection of Thrombin Biomarkers Using a Graphene FET†”, Analyst. 2020 July 07; 145(13): 4494–4503 (hereafter “Khan”) (see the title and Graphical Abstract) or add several FET sensors as taught by Takatsuji in aligned with the measurement electrodes, they would still only be a single recess defined in a side, proximal to the base substrate, of the cover plate.
b) claims 2-11 depend directly or indirectly form allowable claim 1.
c) the combination of limitations in independent claim 12 requires the following highlighted features
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See the discussion above regarding the allowability of claim 1.
d) the combination of limitations in independent claim 13 requires the following underlined features
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See the discussion above regarding the allowability of claim 1.
d) claims 14-20 depend directly or indirectly form allowable independent
claim 13.
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/ALEXANDER S NOGUEROLA/ Primary Examiner, Art Unit 1795
1 “[0074] FIG. 2 shows an exploded view of the exemplary sample chamber of FIG. 1.”
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