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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 16, 2026 has been entered.
Status of the Claims
Claims 11-12, 14, 19, and 24-25 have been amended; claims 1 and 9-10 have been withdrawn; and claims 2-8 have been cancelled. Claims 11-27 are examined herein.
Status of the Rejection
All 35 U.S.C. § 102 and 103 rejections from the previous office action are withdrawn in view of the Applicant’s amendment.
New grounds of rejection under 35 U.S.C. § 102 and 35 U.S.C. § 103 are necessitated by the amendment as outlined below.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11-12, 15-20, 23-25, and 27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Choy (US20230103446A1).
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Annotated Fig.2 in Choy
Regarding claim 11, Choy teaches a sensor assembly (a sensor assembly as shown in Figs. 2 and 6) comprising:
a substrate (see “substrate” in annotated Fig.2 in Choy; the substrate for the discrete electrolyte chambers 120 [para. 0023] is deemed as the substrate) having a first side (top side in contact with the “sensing element”), a second side (bottom side in contact with the “separator”) opposite the first side, and a plurality of holes (discrete electrolyte chambers 120 in Figs. 2 and 6 [para.0016]) extending from the first side to the second side (see Fig.2);
a sensing element (see “sensing element” having nanopore openings 130 in annotated Fig.2 in Choy [para. 0016]) having a sample side (the lower side facing the electrolyte chambers 120) and a buffer side (the upper side facing the common electrolyte chamber 110 in Fig.2 ) opposite the sample side, the sample side of the sensing element mounted to the first side of the substrate (see Fig.2), wherein the sensing element comprises a plurality of nanopores (nanopores 130 in Fig.2 [para. 0016]) through the sensing element and a plurality of cavities (see “cavity” in annotated Fig.2 in Choy; there is a cavity above each nanopore 130 thus there is a plurality of cavities as shown in Fig.2) on the buffer side (as shown in Fig.2, the cavities are on the buffer side of the common electrolyte chamber 110); and
a working electrode (working electrode 140B in Fig.2 [para. 0016]) disposed on the second side of the substrate (see Fig.2), the working electrode disposed at least partially about a hole of the plurality of holes (as shown in Fig.2, each working electrode 140B is disposed in a discrete electrolyte chamber 120).
Regarding claim 12, Choy teaches the sensor assembly of Claim 11, wherein the sample side of the sensing element is configured to contact a test sample (the biological sample can pass through the nanopore opening from the discrete electrolyte chamber to the common electrolyte chamber [para. 0047]; thus the sample side of the sensing element is configured to contact a test biological sample), and the buffer side is configured to contact a control material (the buffer side is configured to contact electrolyte of the common electrolyte chamber 110 [para. 0010]).
Regarding claim 15, Choy teaches the sensor assembly of Claim 11, wherein the sensing element includes no electrical interconnect (Fig.2 shows the sensing element includes no electrical interconnect).
Regarding claim 16, Choy teaches the sensor assembly of Claim 11, further comprising an electrical component mounted on the substrate (Fig.2 shows electrodes 140B [para. 0038] mounted on the substrate of the electrolyte chamber 120).
Regarding claim 17, Choy teaches the sensor assembly of Claim 11, wherein the substrate is a flexible substrate (the discrete electrolyte chamber can be recessed in a substrate, and the substrate can include a material of polydimethylsiloxane [para. 0023]; polydimethylsiloxane is PDMS and is a flexible substrate).
Regarding claim 18, Choy teaches the sensor assembly of Claim 11, wherein the sensing element comprises silicon (An “inorganic membrane” can refer to a solid-state nanopore formed in a membrane of an inorganic material. For example, a solid-state nanopore can be formed in silicon [para. 0027]).
Regarding claim 19, Choy teaches a sample testing device (a sample testing device as shown in Figs. 2 and 6) comprising:
a first compartment (see “first compartment” in annotated Fig.2, and the first compartment is the compartment for the discrete electrolyte chambers 120) configured to receive a test sample (the inlet channel 150 and outlet channel 170 can be arranged to fluidly couple with multiple discrete electrolyte chambers [para. 0032]; Fig.6 shows loading electrolytic fluid 610 into a discrete electrolyte chamber 120 [para. 0045]; note that the discrete electrolyte chambers is configured to load the sample electrolyte since the biological sample can pass through the nanopore opening from the discrete electrolyte chamber to the common electrolyte chamber [para. 0047 ]; thus, the first compartment is configured to receive a test sample); and
a second compartment (see “second compartment” in annotated Fig.2 in Choy) configured to receive the test sample from the first compartment (the biological sample can pass through the nanopore opening from the discrete electrolyte chamber to the common electrolyte chamber [para. 0047 ], thus the second compartment is configured to receive the test sample from the first compartment through the nanopore openings);
wherein the sensor assembly of Claim 11 is disposed in the second compartment (annotated Fig.2 in Choy shows the sensor assembly of claim 11 is disposed in the second compartment).
Regarding claim 20, Choy teaches the sample testing device of Claim 19, further comprising a separator (see “separator” in annotated Fig.2 in Choy) disposed between and separating the first compartment and the second compartment (see Fig.2 in annotated Fig.2 in Choy), wherein the separator opens to transfer the test sample from the first compartment to the second compartment (Fig.6 shows loading electrolytic fluid 610 into a discrete electrolyte chamber 120. The loading can occur by loading the electrolytic fluid through an inlet channel 150 and into the discrete electrolyte chamber via an inlet port 160 [para. 0045]. Thus the separator opens to transfer the test sample from the first compartment to the second compartment through the inlet ports 160).
Regarding claim 23, Choy teaches the sample testing device of Claim 19, wherein the sensing element comprises a silicon sensing element (An “inorganic membrane” can refer to a solid-state nanopore formed in a membrane of an inorganic material. For example, a solid-state nanopore can be formed in silicon [para. 0027]).
Regarding claim 24, Choy teaches the sample testing device of Claim 19, wherein the sample side has a plurality of electrodes exposed to the second compartment (a plurality of electrodes 140B as shown in Fig.2 exposed to the second compartment).
Regarding claim 25, Choy teaches the sample testing device of Claim 24, wherein the plurality of electrodes are disposed about the plurality of nanopores (Fig.2 shows the plurality of electrodes 140B are disposed about the plurality of nanopores [nanopore openings 130]).
Regarding claim 27, Choy teaches the sample testing device of Claim 19, further comprising an air vent channel (outlet ports 180 in Fig.2 [para. 0015]) in communication with the second compartment (see Fig.2), wherein the air vent channel is configured to vent out air in the second compartment as the test sample flows into the second compartment (An example flow path 185 is shown that can be bi-directional or unidirectional. The discrete electrolyte chambers can be loaded, evacuated, vented, filled, or the like, along this flow path [para. 0016]. The channel access openings can work in combination with the waste outlets that can be opened to release air, electrolytic fluid, and/or a non-polar fluid from the inlet channel and/or the outlet channel [para. 0034]. Thus, the air vent channel is configured to vent out air in the second compartment as the test sample flows into the second compartment).
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 13 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Choy, as applied to claims 12 and 25 above, and further in view of Diamond (US 20200326325 A1).
Regarding claim 13, Choy teaches the sensor assembly of Claim 12, and is silent to wherein each of the plurality of nanopores comprises a functionalized layer.
Diamond teaches wherein each of the plurality of nanopores in the sensing element of Fig.9 of the sensor assembly (nanosensor chip 100 in Fig.1) comprises a functionalized layer (the nanopores are functionalized with a layer of probe molecules 520 in Fig. 5A and 5B [0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to functionalize each of the plurality of nanopores in Choy with a layer of probe molecules, as taught by Diamond, since it would allow to bond target molecules flowing through the nanopores and create an aggregated ionic current change that is measurable by current sensor [para. 0041 in Diamond].
Regarding claim 26, Choy teaches the sample testing device of Claim 25, and is silent to wherein the plurality of nanopores of the sensing element includes a functionalized layer.
Diamond teaches wherein each of the plurality of nanopores in the sensing element of Fig.9 of the sensor assembly (nanosensor chip 100 in Fig.1) comprises a functionalized layer (the nanopores are functionalized with a layer of probe molecules 520 in Fig. 5A and 5B [0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to functionalize each of the plurality of nanopores in Choy with a layer of probe molecules, as taught by Diamond, since it would allow to bond target molecules flowing through the nanopores and create an aggregated ionic current change that is measurable by current sensor [para. 0041 in Diamond].
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Choy, as applied to claim 11 above, and further in view of Yanagi et al. (Multichannel detection of ionic currents through two nanopores fabricated on integrated Si3N4 membranes, Lab on a chip, 2016, 16, 3340).
Regarding claim 14, Choy teaches the sensor assembly of Claim 11, and further teaches wherein the sensing element comprises solid-state nanopores formed in a membrane of an inorganic material [para. 0027].
Choy is silent to further comprising an adhesion layer disposed between the substrate and the sensing element, wherein a plurality of holes in the adhesion layer, the plurality of holes in the substrate, and the plurality of nanopores are aligned with each other such that the plurality of nanopores are exposed to a sample reservoir through the plurality of holes in the adhesion laver and the plurality of holes in the substrate.
Yanagi teaches a sensor assembly as shown in Fig.1 comprising an adhesion layer (top SiN layer and the Poly-Si layer in Fig.1) disposed between the substrate (substrate of the flow cell) and the sensing element (the SiN layer beneath the Poly-Si layer and the Si Sub in Fig.1), wherein a plurality of holes in the adhesion layer (see holes in the top SiN and Poly-Si layer), the plurality of holes in the substrate, the plurality of nanopores (nanopore in the SiN layer between the Poly-Si and Si Sub layer), and the plurality of holes in the substrate (holes in the flow cell) are aligned with each other such that the plurality of nanopores are exposed to the plurality of holes in the substrate through the plurality of holes in the adhesion layer (see Fig.1).
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 solid-state nanopore sensing element of Choy to a solid-state nanopore sensing element comprising an adhesion layer disposed between the substrate and the sensing element, wherein a plurality of holes in the adhesion layer, the plurality of holes in the substrate, and the plurality of nanopores are aligned with each other such that the plurality of nanopores are exposed to the plurality of holes in the substrate through the plurality of holes in the adhesion layer, as taught by Yanagi, which teaches the suitable configuration of the solid-state nanopore sensing element as shown in Fig.1.
With the modified sensing element, the plurality of holes in the adhesion layer, the plurality of holes in the substrate, and the plurality of nanopores are aligned with each other such that the plurality of nanopores are exposed to a sample reservoir (a common electrolyte chamber 110 in Fig.2 of Choy) through the plurality of holes in the adhesion layer and the plurality of holes in the substrate.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Choy, as applied to claim 20 above, and further in view of Sundvor et al. (US 20180188239 A1).
Regarding claim 21, Choy teaches the sample testing device of Claim 20, and is silent to further comprising a mechanical lock structure configured to lock and unlock a movement of the separator, wherein when the mechanical lock structure is unlocked, the separator opens to transfer the test sample from the first compartment to the second compartment.
Sundvor teaches a sample testing device (the test container in Fig. 2A detects a target substance [0019, 0022]) comprising a first compartment (first chamber 110 and second chamber 130 connected via opening 132 in Fig. 2A [0019, 0040]); a second compartment (analysis chamber 140 is connected to second chamber 130 via outlet port 136 in Figs. 2A and 6A [0019, 0037]); and wherein a sensor assembly is disposed in the second compartment (detection substrate 150 is disposed in analysis chamber 140 in Fig. 2A [0019]). The device also includes a first compartment housing that at least partially defines the first compartment in an activated position via a plunging function (driving element 120 defines the closed first compartment during sample loading by sliding driving element 120 between openings 112 and 114 in Fig. 2A [0028-0029]). Sundvor further teaches that having two compartments separated by an outlet port enables on-device sample preparation and delivery of a controlled sample volume to the sensor assembly [0019, 0042, 0044], and comprising a mechanical lock structure (controllable spring actuated valve 138 [para. 0045]) configured to lock and unlock a movement of the separator, wherein when the mechanical lock structure is unlocked, the separator opens to transfer the test sample from the first compartment to the second compartment (the spring-actuated valve 138 is controllably actuated to open [i.e., unlock] and close [i.e., lock] the rod that separates the two compartments to allow sample to flow [para. 0045]).
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 sensing device in Choy by providing a mechanical lock structure (spring-actuated valve) configured to lock and unlock a movement of the separator (open or close the inlet port 160 in Fig.2 of Choy), wherein when the mechanical lock structure is unlocked, the separator opens to transfer the test sample from the first compartment to the second compartment, as taught by Sundvor, since it would allow automatically control the sample flow by a controller [para. 0045 in Sundvor].
Allowable Subject Matter
Claim 22 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 22, the prior art does not teach and/or suggest wherein the mechanical lock structure comprises a locking clip that locks a first compartment housing that at least partially defines the first compartment in position.
Response to Arguments
Applicant's arguments, see Remarks Pgs. 5-10, filed 6/16/2026, with respect to the 35 U.S.C. § 102 and 103 rejections have been fully considered, and all rejections from the previous office action are withdrawn in response to the amendment to claims.
Applicant’s Argument #1:
Regarding the 102 rejections, Applicant argues at pages 5-8 that the prior art does not teach the amended features: the substrate having a plurality of holes extending from the first side to the second side, wherein the sensing element comprising a plurality of nanopores through the sensing element and a plurality of cavity on the buffer side.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejection for the amended claim 11 above.
Applicant’s Argument #2:
Regarding the 103 rejections, Applicant argues at pages 8-9 that the dependent claims depend from claim 11, thus are allowable for the same reason for the amended claim 11 above.
Examiner’s Response #2:
As outlined in the new grounds of rejection for claim 11 above, claim 11 is still unpatentable over the new prior art of Choy.
Examiner suggests applicant to incorporate the limitations of claims 20-22 into claim 11.
Conclusion
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/Primary Examiner, Art Unit 1795
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