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 .
Office Action: Notice
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/3/2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on July 29, 2025 is acknowledged. Claims 1-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group 1, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/29/2025. Thus, claims 14-25 are under examination (6/3/2026).
Claim Status
Claims 1-13 have been withdrawn (11/10/2025). Claims 5-7, 10 and 13 were cancelled (6/3/2026). Claims 1-2, 4, 9, 12, 14 and 16-18 have been amended (6/3/2026). Claims 21-25 are new (6/3/2026). No new matter was added. Claims 14-25 are under examination (6/3/2026).
Priority
Claims 14-25 receive a priority date of 4/24/2019, the effective filing date of PCT/JP2019/017336.
Rejections Withdrawn
Claim Rejections - 35 USC § 102
The rejection of claims 14-19 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Huff et al., (WO 2017/004463 A1, published 1/5/2017) is withdrawn in view of Applicant’s amendments of independent claim 14, as well as the Applicant’s arguments (6/3/2026) because the amendments recite structural and functional limitations, including the claimed EWOD electrode configuration and electrically insulated independent droplets (i.e. a plurality of first electrodes embedded in a substrate constituting part of the first liquid tank, electrically insulated independent droplets formed by a water-repellent liquid, and ionic communication through the insulating thin film), that are not expressly or inherently disclosed by Huff. Accordingly, Huff does not teach every limitation of the pending claims as required for anticipation.
New Rejections
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 14-25 are rejected under 35 U.S.C. 103 as being unpatentable over Huff et al., (WO 2017/004463 A1, published 1/5/2017), in view of Lin et al. (“Formation of Droplets Interface Bilayer by Coplanar EWOD Device”, Proceedings of the 2011 6th IEEE International Conference on Nano/Micro Engineered and Molecular Systems, Taiwan, published 2/23/2011).
Regarding claim 14, Huff teaches methods, devices, and systems for analyte analysis using a nanopore via a first and a second binding member that each specifically bind to an analyte in a biological sample and further includes detecting and/or counting a cleavable tag attached to the second binding member and correlating the presence and/or the number of tags to presence and/or concentration of the analyte (Abstract). Further, Huff teaches that the previously described electrochemical method includes a technique where detection electrodes are formed by sputter deposition, where an ion beam bombards a block of metal and vaporizes metal atoms, which are then deposited on a wafer material in the form of a thin film (Paragraph 296, lines 1-3). Further, Huff teaches that a microfluidics device used in conjunction with a nanopore device is depicted (Figures 1A-1B) incorporates fluid droplets which can be analyzed in the nanopore device and includes a tag (i.e., a cleaved tag or an aptamer) that is to be counted using the nanopore device separated by a first chamber or tank and a second chamber or tank (Paragraph 333, lines 1-5), where one or both droplets may be droplets containing analyte to be detected or counted (or cleaved tag or dissociated aptamer) or conductive or electrolytic solution (i.e., buffer not containing an analyte) for analysis via the nanopore (Paragraph 341, lines 1-2). Huff also teaches that upon contact with the capillary channel, the droplets move into the capillary channel via any suitable means, such as, capillary action and can be facilitated by the capillary channel via diffusion, Brownian motion, convection, pumping, applied pressure, gravity-driven flow, density gradients, temperature gradients, chemical gradients, pressure gradients (positive or negative), pneumatic pressure, gas-producing chemical reactions, centrifugal flow, capillary pressure, wicking, electric field-mediated, electrode-mediated, electrophoresis, dielectrophoresis, magnetophoresis, magnetic fields, magnetically driven flow, optical force, chemotaxis, phototaxis, surface tension gradient driven flow, Marangoni stresses, thermo-capillary convection, surface energy gradients, acoustophoresis, surface acoustic waves, electroosmotic flow, thermophoresis, electrowetting, opto-electrowetting, or combinations thereof (Paragraph 340, lines 1-5).
Regarding claims 15-16, Huff teaches that the previously described methods may include one or more (or alternately two or more) specific binding members or electrodes to detect one or more (or alternately two or more) target analytes in the sample in a multiplexing assay where each of the one or more (or alternately two or more) specific binding members binds to a different target analyte and each specific binding member is labeled with a different tag and/or aptamer (Paragraph 252, lines 1-5). Huff teaches that the previously described electrochemical method includes application of an electric field, such as a voltage across the nanopore- enabled layer leads to the eventual formation of a nanopore, which can be readily detected, i.e., as a dielectric breakdown in a current trace (Figure 40; Paragraph 403, lines 15-20).
Regarding claim 17, Huff teaches that the previously described method includes an array of electrodes where a series of individually controllable electrodes where the single electrode may serve as a reference or a grounding electrode, while the array of electrodes may be individually controllable (for example, the array of electrodes may be actuation electrodes that can be actuated independently) (Figure 2F; Paragraph 342, lines 1-15). Further, Huff teaches that
when a nanopore is to be created in the membrane, a voltage is applied to the salt solution in the cis and trans chamber or tank and conductance through the membrane measured and prior to the creation of a nanopore, there is no or minimal current measured across the membrane and following creation of a nanopore, the current measured across the membrane increases dependent on sufficient time allotments (Paragraph 302, lines 1-10). Huff also teaches that various types of nanopores may be used for analyzing the tags/aptamer, including, among others, biological nanopores that employ a biological pore or channel embedded in a membrane or, the nanopore is a solid state nanopore produced using controlled dielectric breakdown (Paragraph 278, lines 1-5). Huff also teaches that upon contact with the capillary channel, the droplets move into the capillary channel via any suitable means, such as, capillary action and can be facilitated by the capillary channel via diffusion, Brownian motion, convection, pumping, applied pressure, gravity-driven flow, density gradients, temperature gradients, chemical gradients, pressure gradients (positive or negative), pneumatic pressure, gas-producing chemical reactions, centrifugal flow, capillary pressure, wicking, electric field-mediated, electrode-mediated, electrophoresis, dielectrophoresis, magnetophoresis, magnetic fields, magnetically driven flow, optical force, chemotaxis, phototaxis, surface tension gradient driven flow, Marangoni stresses, thermo-capillary convection, surface energy gradients, acoustophoresis, surface acoustic waves, electroosmotic flow, thermophoresis, electrowetting (EWOD), opto-electrowetting, or combinations thereof (Paragraph 340, lines 1-5).
Regarding claim 18, Huff teaches methods, devices, and systems for analyte analysis using a nanopore via a first and a second binding member that each specifically bind to an analyte in a biological sample and further includes detecting and/or counting a cleavable tag attached to the second binding member and correlating the presence and/or the number of tags to presence and/or concentration of the analyte (Abstract). Further, Huff teaches that the previously described electrochemical method includes a technique where detection electrodes are formed by sputter deposition, where an ion beam bombards a block of metal and vaporizes metal atoms, which are then deposited on a wafer material in the form of a thin film (Paragraph 296, lines 1-3). Further, Huff teaches that a microfluidics device used in conjunction with a nanopore device is depicted (Figures 1A-1B) incorporates fluid droplets which can be analyzed in the nanopore device and includes a tag (i.e., a cleaved tag or an aptamer) that is to be counted using the nanopore device separated by a first chamber or tank and a second chamber or tank (Paragraph 333, lines 1-5), where one or both droplets may be droplets containing analyte to be detected or counted (or cleaved tag or dissociated aptamer) or conductive or electrolytic solution (i.e., buffer not containing an analyte) for analysis via the nanopore (Paragraph 341, lines 1-2).
Regarding claim 19, Huff teaches that the previously described electrochemical method includes a proximal portion and a distal portion where the nanopore layer is disposed in the distal portion and the array of electrodes in the proximal portion is configured to generate a droplet, where the array is configured to position the droplet across the nanopore layer such that the droplet is split by the nanopore layer into a first portion and a second portion, wherein at least two electrodes of the array of electrodes are positioned across the nanopore layer, where the two electrodes form an anode and a cathode and operate to drive current through a nanopore in the nanopore layer when a liquid droplet is positioned across the nanopore layer (Paragraph 9, lines 5-15).
Regarding claims 20-25, Huff teaches that the previously described electrochemical method includes application of an electric field, such as a voltage across the nanopore- enabled layer leads to the eventual formation of a nanopore, which can be readily detected, i.e., as a dielectric breakdown in a current trace (Figure 40; Paragraph 403, lines 15-20). Further, Huff teaches that when a nanopore is to be created in the membrane, a voltage is applied to the salt solution in the cis and trans chamber or tank and conductance through the membrane measured and prior to the creation of a nanopore, there is no or minimal current measured across the membrane and following creation of a nanopore, the current measured across the membrane increases dependent on sufficient time allotments (Paragraph 302, lines 1-10). Huff also teaches that various types of nanopores may be used for analyzing the tags/aptamer, including, among others, biological nanopores that employ a biological pore or channel embedded in a membrane or, the nanopore is a solid state nanopore produced using controlled dielectric breakdown (Paragraph 278, lines 1-5).
Huff does not teach or suggest using a water-repellent liquid to electrically insulate a plurality of droplets from adjacent droplets, thereby forming a plurality of independent individual solution tanks. Huff also does not teach the claimed arrangement, at specific voltage ranges (10 to 50 volts) in which each electrically isolated droplet maintains ionic communication with an electrolyte solution in the second liquid tank through insulating thin film at a thickness at 1A to 200 nm.
Lin teaches an EWOD microfluidic device for individually manipulating encapsulated aqueous droplets (Abstract) using Ag/AgCl electrodes and patch-clamp circuitry measure ionic current through the membrane/ion channels (DIB Formation, Ion Channel Incorporation; Figures 4-5). Further, Lin teaches coplanar EWOD electrodes patterned on top and bottom glass plates, with a dielectric layer and a hydrophobic Teflon layer, and teaches transporting encapsulated droplets comprising an aqueous KCl core surrounded by a lipid/decane oil shell using the EWOD electrodes (Figure 1; “Coplanar EWOD Device for Encapsulated Droplet”). Lin further teaches independently driving two encapsulated droplets toward an aperture and forming a lipid bilayer between the droplets, thereby providing an isolated droplet environment, with ionic current measured across the resulting membrane structure (Abstract, DIB Formation and Ion Channel Incorporation; Figures 1, 3-5). Lin also teaches the application of electrical signals to coplanar electrodes changes the contact angle and moves the encapsulated droplet toward the powered electrode pair (Figure 1a; Principle). Specifically, Lin teaches that patterned EWOD electrodes, 500 nm thick SiO2 dielectric layer, and 55 nm thick Teflon hydrophobic layer (Coplanar EWOD Device for Encapsulated Droplet; Figure 1) and droplets comprise a KCl aqueous core and decane oil shell (Experiment: Materials and Coplanar EWOD Device for Encapsulated Droplet).
Regarding claims 20-25, Lin teaches controlling droplet movement by applying voltage to EWOD electrodes to alter droplet contact angle (Principle). Although Lin does not expressly teach the claimed 10-50 V range, optimization of the applied voltage to achieve effective EWOD droplet movement would have been a matter of routine optimization of a result-effective variable. Lin further teaches aqueous droplets encapsulated by a water-repellent decane oil shell (Materials and Coplanar EWOD Device for Encapsulated Droplet), where selection of another known water repellant oil, such as silicone, fluorine-based, or mineral oil, would have been an obvious selection of a known alternative having the same predictable function. Lin expressly teaches a 500 nm SiO2 dielectric layer, thereby teaching silicon oxide as a dielectric material (Coplanar EWOD Device for Encapsulated Droplet).
Further, regarding claim 23, although Lin teaches a 500-nm SiO2 dielectric layer rather than the claimed 1A-200 nm range, optimization of dielectric-layer thickness would have been an obvious matter of routine optimization where thickness affects EWOD performance (Coplanar EWOD Device for Encapsulated Droplet).
Regarding claim 24, Lin teaches individually manipulating multiple encapsulated droplets using independently controlled EWOD electrodes (Principle and Experiment). It would have been obvious to one of ordinary skill in the art to provide different sample types in the individually controlled droplets and measure the samples simultaneously, thereby permitting multiplexed analysis and increasing analytical efficiency and throughput.
Specifically, regarding claim 25, Lin teaches droplets having approximately 1.5 uL and 3 uL KCl cores, thereby teaching droplet volumes within the claimed microliter-to-nanoliter range (Coplanar EWOD Device for Encapsulated Droplet and DIB Formation).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Huff, as modified by Lin, to provide different sample types in the individually controlled droplets and simultaneously measure the different sample types. One of ordinary skill in the art would have been motivated to make such a modification to permit multiplexed analysis of different samples and thereby increase analytical efficiency and throughput. One of ordinary skill would have had a reasonable expectation of success because Lin teaches the individual manipulation and control of multiple encapsulated droplets using EWOD electrodes, such that different samples could predictably be maintained and manipulated in respective droplets, while Huff teaches electrical analysis of samples using nanopores.
Applicant’s Response: The Applicant argues that the primary reference, Huff, does not disclose the claimed EWOD architecture, particularly a water-repellent liquid that electrically insulates multiple droplets to dorm independent individual solution tanks while permitting ionic communication through the insulating thin film. Applicant further argues that Huff’s disclosed droplet manipulation, electrode arrangement, and applied voltages relate to a fundamentally different configuration and therefore do not anticipate the amended claims.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered and are found to be partially persuasive, as discussed below.
The new USC 103 rejection, as written above, addresses the Applicant’s remarks, as well as amended independent claim 14 and new claims 20-25. Specifically, as showcased above, Huff has not been shown to expressly or inherently disclose the claimed water-repellent liquid electrically insulating the plurality of droplets from adjacent droplets to form independent individual solution tanks while providing the recited ionic communication through the insulating thin film; accordingly, the anticipation rejection is withdrawn.
However, the arguments do not render the amended claims patentable because a new rejection under 35 USC 103 has been made over Huff in view of Lin, wherein Lin teaches an EWOD configuration employing individually manipulated, oil-encapsulated aqueous droplets and an isolated droplet environment, and the combination would have predictably provided the claimed droplet isolation and manipulation, as discussed above. See MPEP 2141 and 2143. Specifically, the combination of Huff and Lin renders the presently claimed subject matter obvious because Huff teaches contemplating electrowetting for droplet manipulation, while Lin teaches a known EWOD implementation employing individually manipulated aqueous droplets encapsulated by a water-repellent oil phase. It would have been obvious to one of ordinary skill in the art to employ Lin’s EWOD droplet configuration in Huff’s nanopore system to provide controlled and independent manipulation of aqueous droplets while preventing unintended contact and electrical communication between adjacent droplets, thereby providing isolated individual solution volumes. One of ordinary skill would have had a reasonable expectation of success because both references employ electrically controlled microfluidic droplets and membrane-based electrical analysis, and Lin demonstrates successful EWOD manipulation of isolated electrolyte-containing droplets. Thus, the combination represents the predictable use of a known EWOD technique according to its established function. See MPEP 2141 and 2143.
To overcome the rejection, Applicant may amend the claims to recite additional structural or functional limitations that patentably distinguish the claimed device from the combined teaches of Huff and Lin. For example, Applicant may further define the particular spatial or structural relationship among the independent droplets, water-repellent liquid, insulating thin film, nanopores, and/or first and second liquid tanks.
Rejections Maintained
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Application No. 16/463,502
Claims 14-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 8 of co-pending Application No. 16/463,502 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons that follow. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending claim 1 recites “A nanopore forming method that is a method of applying a voltage to a thin film to form a nanopore, comprising: applying a first modulation voltage to a thin film; comparing an amount of a change in a phase of a current carried through the thin film with respect to a phase of the first modulation voltage with a threshold; and upon detecting that the amount of the change in the phase exceeds the threshold, stopping application of the first modulation voltage.”
Co-pending claim 2 recites “The nanopore forming method according to claim 1, wherein a parameter of the first modulation voltage is determined corresponding to an impedance of the thin film.”.
Co-pending claim 3 recites “The nanopore forming method according to claim 2, wherein before application of the first modulation voltage, the impedance of the thin film is measured.”
Co-pending claim 8 recites “The nanopore forming method according to claim 1, wherein: a plurality of the thin films is provided such that the thin films are isolated from each other by a wall, and the first modulation voltage is applied to each of the plurality of thin films; an amount of a change in a phase of a current carried through each of the thin films with respect to the phase of the first modulation voltage is individually compared with the threshold; and application of the first modulation voltage is stopped on a thin film on which the amount of the change in the phase exceeds the threshold is detected.”
The difference between the present application and 17/604,881 is claims 14-16 of 17/604,881 recites a biopolymer analysis method that includes preparing an analysis device with liquid tanks, introducing droplets, conveying droplets by electrowetting, introducing an electrolyte solution, and analyzing biopolymers based on current values when the biopolymer passes through the nanopore. Claims 1-3 and 8 of the present application, 16/463,502 recite a nanopore forming method comprises applying voltage to a thin film, comparing phase changes in current with a threshold, and stopping voltage application when the threshold is exceeded. Thus, it would be obvious to one of ordinary skill in the art that the nanopore forming method of claims 1-3 and 8 of the present application, 16/463, 502, could be incorporated into a biopolymer analysis device as recited in claims 14-16 of 17/604,881. The addition of biopolymer analysis steps to the disclosed nanopore formation method would be a natural and obvious extension of the technology for its intended purpose. Thus, the subject matter of claims 1-3 and 8 of the present application, 16/463,502 would be obvious to one of ordinary skill in the art in view of the disclosure of claims 14-16 of 17/604,881.
Application No. 18/018,084
Claims 14-16 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 12 of co-pending Application No. 18/018,084 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons that follow. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending claim 1 recites “A biomolecule analysis method comprising: preparing a biomolecule analysis device including a thin film, a first liquid tank and a second liquid tank separated by the thin film, a first electrode disposed in the first liquid tank, and a second electrode disposed in the second liquid tank; and forming a nanopore in the thin film by applying a first voltage between the first electrode and the second electrode in a state where a nanopore forming solution is enclosed in the first liquid tank and the second liquid tank, wherein the nanopore forming solution contains ammonium ions and sulfate ions.”
Co-pending claim 2 recites “A biomolecule analysis method comprising: preparing a biomolecule analysis device including a thin film having a nanopore, a first liquid tank and a second liquid tank separated by the thin film, a first electrode disposed in the first liquid tank, and a second electrode disposed in the second liquid tank; and measuring a current flowing between the first electrode and the second electrode by applying a voltage between the first electrode and the second electrode in a state where a measurement solution is enclosed in the first liquid tank and the second liquid tank, wherein the measurement solution contains ammonium ions and sulfate ions.”
Co-pending claim 3 recites “The biomolecule analysis method according to claim 1, further comprising measuring a current flowing between the first electrode and the second electrode by applying a second voltage between the first electrode and the second electrode in a state where a measurement solution is enclosed in the first liquid tank and the second liquid tank after formation of the nanopore, wherein the measurement solution contains the ammonium ions and the sulfate ions.”
Co-pending claim 12 recites “The biomolecule analysis method according to claim 2, further comprising: introducing a biomolecule into the measurement solution when measuring the current; and analyzing the biomolecule based on a measurement result of the current.”
The difference between the present application and 17/604,881 is claims 14-16 and 18 of 17/604,881 recites a biopolymer analysis method that includes preparing an analysis device with liquid tanks, introducing droplets, conveying droplets by electrowetting, introducing an electrolyte solution, and analyzing biopolymers based on current values when the biopolymer passes through the nanopore. Claims 1-3 and 12 of the present application, 18/018,084 recite a biomolecule analysis method comprising applying voltage to thin film, comparing phase changes in current with a threshold, and stopping voltage application when the threshold is exceeded, wherein the nanopore forming solution and measurement solution contain ammonium ions and sulfate ions. Thus, it would be obvious to one of ordinary skill in the art that the nanopore forming method of claims 1-3 and 12 of the present application, 18/018,084, could be incorporated into a biopolymer analysis device with electrowetting droplet manipulations recited in claims 14-16 and 18 of 17/604,881. The addition of electrowetting-based droplet handling to the disclosed nanopore-based biomolecule analysis method would be a natural and obvious combination for improving the analytical capabilities of the device. Thus, the subject matter of claims 1-3 and 12 of the present application, 18/018,084 would be obvious to one of ordinary skill in the art in view of the disclosure of claims 14-16 and 18 of 17/604,881.
Applicant’s Response: The Applicant requests withdrawal of the non-statutory obviousness-type double patenting rejection because neither the present claims nor the claims of the copending Application have been patented.
Examiner’s Response to Traversal: Applicant’s arguments regarding the provisional nonstatuatory obviousness type double patenting rejection have been considered, but are not persuasive. Applicant argues that the rejection is premature because neither the present claims nor the claims of the copending application have issued a patent. However, a provisional nonstatuatory double patenting rejection is appropriate where patentably indistinct claims are presented in copending applications, notwithstanding that neither application has yet issued. See MPEP 804 and 1490. Accordingly, because the presently claimed subject matter remains not patentably distinct from the claims of the identified copending applications, the provisional nonstatuatory obviousness-type double patenting rejection is maintained.
Conclusions
No claim is allowed.
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/ELIZABETH ROSE LAFAVE/
Examiner, Art Unit 1684
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684
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