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 6/13/2023 has been considered by the examiner.
Election/Restrictions
Applicant’s election of Species A claims 1-10 in the reply filed on 10/28/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
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 and 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (US 20230296582 A1), Hyde et al. (US 20150265994 A1), and Waterman et al. (US 20200266568 A1).
Regarding claim 1, Hall teaches a nanopore sensing system (nanopore array device 1 in Fig. 1 [0036]), comprising:
an application specific integrated circuit (ASIC) sensor mounted on a printed circuit board (PCB) having an electrical interface with the ASIC sensor (data processor 5 in Fig. 1 formed on a common circuit board [0085]); and
a nanopore sequencer (sensor device 3 in Figs. 1-2 [0036-0038]) including:
a redox mediator chamber (sample chamber 36 in Fig. 2 contains a redox couple associated with the common electrode [0038]) having a cis electrode positioned therein (common electrode 37 in Fig. 2 provides a common reference signal [0038]);
a cis well (sample chamber 36 in Fig. 2 contains test solution [0038]);
a plurality of trans wells (array of wells 33 in Fig. 2 [0038]), each including a trans electrode positioned therein (electrodes 31 [0037-0038]); and
a plurality of nanopores respectively fluidically connecting the cis well to each of the plurality of trans wells (nanopores 35 connect sample chamber 36 to wells 33 in Fig. 2 [0038]).
Hall is silent to the following limitations: (1) the nanopore sequencer formed on the ASIC sensor; and (2) a membrane positioned between the cis well and the redox mediator chamber, the membrane to confine a redox mediator species in the redox mediator chamber and to allow an ionic species to pass between the redox mediator chamber and the cis well.
Regarding limitation (1): Hyde teaches a nanopore sequencer, wherein an array of membranes accommodate nanopores for DNA sequencing [Abstract, 0006]. The array is formed on an ASIC/PCB to form an all-in-one flow chip apparatus (array 101 is attached on top of ASIC/PCB 105 and held in place via compression from screws 109 in Fig. 27 [0243, 0421, 0423]).
Hall and Hyde are both considered analogous to the claimed invention because they are in the same field of nanopore sensing systems. 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 nanopore sequencer in Hall by forming the nanopore sequencer on top of the ASIC sensor, as taught in Hyde, since this would form an all-in-one flow chip apparatus [0243, 0421, 0423 in Hyde]. Furthermore, Hyde teaches the claimed improvement as a known technique that is applicable to the base device in Hall. One skilled in the art could have applied the nanopore sequencer formed on top of the ASIC sensor in Hyde in the same way to the base device in Hall, yielding predictable results (MPEP 2143(I)(D)).
Additionally, the use of a one-piece, integrated construction instead of the structure disclosed or taught in the prior art would have been within the ambit of a person of ordinary skill in the art. See In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (see MPEP § 2144.04).
Regarding limitation (2): Waterman teaches a sensing array (sensing array composed of an array of wells 5 in Fig. 14 [0090]) with a redox mediator chamber having a cis electrode positioned therein (ionic solution containing a redox mediator that contacts common electrode 241 in Fig. 16 is contained in a separate channel under ion selective barrier 24 [0092]); a cis well (channel containing the test solution above barrier 24 [0092]); a membrane positioned between the cis well and the redox mediator chamber (ion selective barrier 24 in Fig. 16 [0092]), the membrane to confine a redox mediator species in the redox mediator chamber and to allow an ionic species to pass between the redox mediator chamber and the cis well (barrier 24 prevents the redox mediator from entering the test solution while allowing ions to pass [0092]). Waterman further teaches that separating the redox mediator solution from the test solution using an ion selective membrane prevents the redox mediator from interfering with components in the test solution [0092].
Modified Hall and Waterman are both considered analogous to the claimed invention because they are in the same field of sensing arrays. 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 redox mediator chamber and cis well in modified Hall by forming a separate redox mediator chamber and cis well using a membrane positioned between the cis well and the redox mediator chamber, the membrane to confine a redox mediator species in the redox mediator chamber and to allow an ionic species to pass between the redox mediator chamber and the cis well, as taught in Waterman, since this would prevent the redox mediator from interfering with components in the test solution [0092 in Waterman]. Furthermore, Waterman teaches the claimed improvement as a known technique that is applicable to the base device in modified Hall. One skilled in the art could have applied the redox mediator chamber and cis well separated by the ion permeable membrane in Waterman in the same way to the base device in modified Hall, yielding predictable results (MPEP 2143(I)(D)).
Regarding claim 4, modified Hall teaches the nanopore sensing system as defined in claim 1, and further teaches wherein the membrane is an ion exchange membrane (as stated in the rejection of claim 1 above, the membrane used to separate the redox mediator chamber and the cis well is an ion selective membrane [0092 in Waterman]).
Regarding claim 5, modified Hall teaches the nanopore sensing system as defined in claim 1, and further teaches wherein the membrane is a size selective membrane (the ion selective barrier would also inherently prevent particles of a certain size from crossing between the redox mediator chamber and the cis well [0092 in Waterman]).
Regarding claim 6, modified Hall teaches the nanopore sensing system as defined in claim 1, and further teaches wherein: the redox mediator chamber includes a first inlet and a first outlet (the channel containing the redox mediator includes inlet and outlet ports 221 and 222 in Fig. 16 of Waterman [0092]); wherein the cis well includes a second inlet (a solution containing the analyte is loaded into to the sample chamber [0007, 0053 in Hall])
Modified Hall is silent to the limitation wherein the cis well includes a second inlet and a second outlet.
Waterman teaches that an outlet in a sample chamber allows gas to vent out of the chamber as it is replaced by a sample solution flowing through an inlet [0005].
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 cis well in modified Hall by including an outlet, as taught in Waterman, such that the outlet associated with the cis well is a second outlet, since this would allow gas to vent out of the chamber [0005 in Waterman]. Furthermore, Waterman teaches the claimed improvement as a known technique that is applicable to the base device in modified Hall. One skilled in the art could have applied the sample loading outlet in Waterman in the same way to the base device in modified Hall, yielding predictable results (MPEP 2143(I)(D)).
Regarding claim 7, modified Hall teaches the nanopore sensing system as defined in claim 6, but is silent to the limitation wherein the redox mediator chamber is positioned so that fluid flow from the first inlet to the first outlet is in a first direction and the cis well is positioned so that fluid flow from the second inlet to the second outlet is in a second direction that is perpendicular to the first direction.
However, achieving the claimed invention based on modified Hall would merely constitute a rearrangement of parts (i.e., rearranging the positions of the first inlet, first outlet, second inlet, and second outlet to achieve perpendicular fluid flow directions). Rearrangement of parts where both arrangements are known equivalents is a design choice that gives predicable results. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); 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) [see MPEP 2144.04 (VI)].
Regarding claim 8, modified Hall teaches the nanopore sensing system as defined in claim 6, but is silent to the limitation wherein the redox mediator chamber is positioned so that fluid flow from the first inlet to the first outlet is in a first direction and the cis well is positioned so that fluid flow from the second inlet to the second outlet is also in the first direction.
However, achieving the claimed invention based on modified Hall would merely constitute a rearrangement of parts (i.e., rearranging the positions of the first inlet, first outlet, second inlet, and second outlet to achieve fluid flow in the same direction). Rearrangement of parts where both arrangements are known equivalents is a design choice that gives predicable results. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); 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) [see MPEP 2144.04 (VI)].
Regarding claim 9, modified Hall teaches the nanopore sensing system as defined in claim 1, and further teaches wherein the ASIC sensor is permanently mounted on the printed circuit board (the ASIC is permanently integrated onto a common circuit board [0085 in Hall]).
Regarding claim 10, modified Hall teaches the nanopore sensing system as defined in claim 1, and further teaches wherein each of the plurality of nanopores is a biological nanopore inserted into a material positioned between the cis well and each of the plurality of trans wells (nanopores 35 are nanopore channels comprising protein pores inserted into membranes 32 in Fig. 2 [0021, 0038 in Hall]), wherein the material is selected from the group consisting of a material of biological origin and a solid state material (membrane 32 is a lipid bilayer or solid-state substrate [0021, 0047-0048]).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Hall, Hyde, Waterman, and further in view of Lalonde et al. (US 20190262827 A1) and Fomina et al. (US 20180318834 A1).
Regarding claim 2, modified Hall teaches the nanopore sensing system as defined in claim 1, but is silent to the limitation wherein the ASIC sensor is removably mounted on the printed circuit board.
Lalonde teaches an ASIC sensor mounted on a PCB using pogo pin connections (ASIC 676 electrically connects to PCB 652 via pogo pin connectors 658 in Fig. 6 [0099]).
Fomina teaches that using pogo pin connections enables the removable mounting of components [0362].
Modified Hall, Lalonde, and Fomina are considered analogous to the claimed invention because they are in the same field of sensors on chips. 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 ASIC sensor in modified Hall by mounting the ASIC to the PCB using pogo pin connections, as taught in Lalonde, since this would enable the removable mounting of the ASIC sensor to the PCB [0362 in Fomina]. Furthermore, Lalonde teaches the claimed improvement as a known technique that is applicable to the base device in modified Hall. One skilled in the art could have applied the pogo pin connections in Lalonde in the same way to the base device in modified Hall, yielding predictable results (MPEP 2143(I)(D)).
Regarding claim 3, modified Hall teaches the nanopore sensing system as defined in claim 2, and further teaches wherein the electrical interface includes a connection to connect the cis electrode to a ground circuit connected to the printed circuit board (common electrode 37 connects to bias control circuit 41 in Figs. 1-2, and bias control circuit 41 is part of detection circuit 2, which is formed on the common circuit board [0083 in Hall]). Modified Hall is silent to the limitation wherein the connection is a pogo pin connection that removably connects the cis electrode to the ground circuit.
However, based on the rejection of claim 2, 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 connection between the cis electrode and the ground circuit in modified Hall by using a pogo pin connection, as taught in Lalonde, since this would facilitate the removable mounting of the ASIC sensor to the PCB [0362 in Fomina]. Furthermore, Lalonde teaches the claimed improvement as a known technique that is applicable to the base device in modified Hall. One skilled in the art could have applied the pogo pin connection in Lalonde in the same way to the base device in modified Hall, yielding predictable results (MPEP 2143(I)(D)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLEE Y TSENG whose telephone number is (703)756-5542. The examiner can normally be reached Mon - Fri 9-6 PT.
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/K.T./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795