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 .
Status of Amendment
The amendment filed on 25 June 2026 fails to place the application in condition for allowance.
Claims 1, 2, 4-20 are currently pending and under examination.
Status of Rejections
The rejections of claims 1, 2, and 4-20 under 35 U.S.C. 112(b) are herein withdrawn due to Applicant’s amendment filed 25 June 2026.
All other rejections are herein maintained in light of previously cited art teachings.
Note: The Non-Final Rejection included a rejection of Feng in view of Xie and Arcadia, see pgs. 7-8. The Acadia reference was inadvertently not included in the title of the rejection. The teachings cited are relevant and maintained here. All claims are properly finally rejected under 35 U.S.C. 112(a) as necessitated by the amendment and 35 U.S.C. 102/103 under the Waugh primary reference.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, and 4-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to the limitation “such that the membrane has a voltage value greater than a predetermined threshold voltage” in independent claims 1, 8, 11, and 18 is deemed new matter because the phrase is not found within the instant specification. The instant specification does not recite “the membrane has a voltage…”. The voltages claimed are drawn towards the applied voltage and a monitored voltage, which may be related to the membrane but are not voltages of the membrane.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Waugh et al (Waugh, M., Briggs, K., Gunn, D. et al. Solid-state nanopore fabrication by automated controlled breakdown. Nat Protoc 15, 122–143 (2020). https://doi.org/10.1038/s41596-019-0255-2).
As to claim 1, Waugh discloses a pore forming method (Title) comprising:
disposing a membrane between a first electrolyte solution and a second electrolyte solution (Fig. 1 overview Fig. 1A showing the SiNx membrane between two solutions, pg. 136 chip mounting and membrane wetting procedures);
bringing a first electrode into contact with the first electrolyte solution and a second electrode into contact with the second electrolyte solution (Shown schematically in Fig. 1 and pg. 136 membrane wetting section step 43 “insert an electrode into the central well on either side of each chip;
outputting a first voltage from a voltage source to a circuit configured by disposing the voltage source ( pg. 140 step 58). To a circuit configured by disposing the voltage source and a resistor in a wiring connecting the first electrode and the second electrode. (Fig. 2c AND supplementary information S20 circuit diagram with 1 MΩ resistor attached via the “Applied voltage monitored” line which satisfied instant claim 6 value of the resistor being less than 100 GΩ)
measuring a second voltage between the first electrode and the second electrode; detecting a significant change in the second voltage; and stopping output of the first voltage in response to detecting the significant change in the second voltage (Fig. 5 panel B showing the monitored voltage and threshold line thus necessary detecting the significant change pg. 129 “the rapid drop of the applied voltage to zero”).
As to claim 2 and the recitation of “wherein the change in the second voltage comprises a change rate of the second voltage that exceeds a predetermined change rate threshold such that the membrane has a voltage value greater than a predetermined threshold voltage” in instant claim 1, the type of change, i.e. an arbitrary predetermined voltage threshold and a change rate, are inherently satisfied through the continued monitoring of the voltage described in Waugh because the changes described necessarily happen during the breakdown event as the pore is formed (See [0028] and Fig. 8), upon which the voltage is stopped in Waugh. Waugh further shows the voltage exceeding the threshold voltage up[on formation of the nanopore (Fig. 5b far right side of the graph).
As to claims 4 and 5, Waugh discloses the thickness of the SiNx membranes at approximately 10 nm (pg. 132 “Critical” identification) with a breakdown voltage of approximately 10 V (pg. 137 step 58) which amounts to the voltage/thickness to be approximately 1 V/nm which falls within the instantly claimed range.
As to claim 7, Waugh discloses wherein the predetermined voltage threshold is more than 0 V and less than or equal to the first voltage - 10 mV. (Fig. 5b where the voltage threshold is shown below the voltage line and less than 10 V).
As to claim 8, Waugh discloses a pore forming apparatus (Fig. 2) comprising:
a membrane (Fig. 2 “chip”) disposed between a first electrolyte solution and a second electrolyte solution (Fig. 2 “flow channel” on each side of the chip that connects to the hole in the gasket);
a first electrode disposed to be in contact with the first electrolyte solution and a second electrode disposed to be in contact with the second electrolyte solution (Fig. 2 “electrode”);
a wiring connecting the first electrode and the second electrode (Circuit diagram which necessarily required wiring in order to connect the electrical circuit);
a voltage source that is disposed in the wiring and outputs a first voltage (Fig. 5 “voltage source” and Fig. 2 “applied voltage” which necessarily requires a source to apply the voltage)
a resistor disposed in the wiring (Fig. 2 resistor on “applied voltage monitored” line);
a voltmeter that measures a second voltage between the first electrode and the second electrode (in order to monitor the voltage a voltmeter is necessarily required pg. 133 “The fabrication electronic circuit is simple and consists of a dedicated, low-bandwidth (4-kHz) transimpedance current amplifier circuit for each chip mounted, each with three independent sections. The first section doubles the input command voltage controlled by the DAQ card (maximum analog output (AO) of ±10 V), allowing voltages up to ±20 V to be applied, provided that sufficient power is supplied to the op-amps. The second section amplifies the resulting current and converts it to a voltage signal before filtering at 4 kHz using an analog 4-pole low-pass Bessel filter. The third section divides the applied voltage by 10 to bring it back to within the dynamic range of the analog inputs (AIs) of the NI DAQ (±10 V) such that it can be recorded and compared with the
desired applied voltage.”); and
a control unit that detects a significant change in the second voltage and stops output of the first voltage in response to detecting the significant change in the second voltage (the “DAQ” above coupled to the software on the computer in the citation above, “e DAQ card is turned on and connected to the computer, and press the dropdown arrow for each of the three fields, Voltage-Out (voltage applied), Voltage-In (voltage read), and Current-In (current read), i to select the correct AOs and AIs connected to the Circuit” pg. 134., carrying out the method above Fig. 5 panel B showing the monitored voltage and threshold line thus necessary detecting the significant change pg. 129 “the rapid drop of the applied voltage to zero”).
As to the recitation of “wherein the change in the second voltage comprises a change rate of the second voltage that exceeds a predetermined change rate threshold such that the membrane has a voltage value greater than a predetermined threshold voltage” in instant claim 1, the type of change, i.e. an arbitrary predetermined voltage threshold and a change rate, are inherently satisfied through the continued monitoring of the voltage described in Waugh because the changes described necessarily happen during the breakdown event as the pore is formed (See [0028] and Fig. 8), upon which the voltage is stopped in Waugh. Waugh further shows the voltage exceeding the threshold voltage up[on formation of the nanopore (Fig. 5b far right side of the graph).
As to claims 9 and 10, the type of change, i.e. an arbitrary predetermined voltage threshold and a change rate, are inherently satisfied through the continued monitoring of the voltage described in Waugh because the changes described necessarily happen during the breakdown event as the pore is formed (See [0028] and Fig. 8), upon which the voltage is stopped in Waugh.
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 11-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Waugh et al (Waugh, M., Briggs, K., Gunn, D. et al. Solid-state nanopore fabrication by automated controlled breakdown. Nat Protoc 15, 122–143 (2020). https://doi.org/10.1038/s41596-019-0255-2) in view of Feng et al (US 2018/0073161 A1).
As to claim 11, Waugh discloses a pore forming method (Title) comprising:
disposing a membrane between a first electrolyte solution and a second electrolyte solution (Fig. 1 overview Fig. 1A showing the SiNx membrane between two solutions, pg. 136 chip mounting and membrane wetting procedures);
bringing a first electrode into contact with the first electrolyte solution and a second electrode into contact with the second electrolyte solution (Shown schematically in Fig. 1 and pg. 136 membrane wetting section step 43 “insert an electrode into the central well on either side of each chip;
outputting a first voltage from a voltage source to a circuit configured by disposing the voltage source ( pg. 140 step 58) to a circuit configured by disposing the voltage source, a capacitor in a wiring connecting the first electrode and the second electrode. (Fig. 2c AND supplementary information S20 circuit diagram with 47µF capacitor)
measuring a second voltage between the first electrode and the second electrode; detecting a significant change in the second voltage; and stopping output of the first voltage in response to detecting the significant change in the second voltage (Fig. 5 panel B showing the monitored voltage and threshold line thus necessary detecting the significant change pg. 129 “the rapid drop of the applied voltage to zero”).
Waugh fails to explicitly disclose a switch.
Feng discloses using a switch to turn of the pore forming voltage one a voltage exceeds a threshold value ([0088]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have used a switch as taught by Feng in the circuit of Waugh because it allows for the switching off the voltage once the pore has been formed (Feng [0088]).
As to claim 12, 13 and the recitation of “wherein the change in the second voltage comprises a change rate of the second voltage that exceeds a predetermined change rate threshold such that the membrane has a voltage value greater than a predetermined threshold voltage” in instant claim 1, the type of change, i.e. an arbitrary predetermined voltage threshold and a change rate, are inherently satisfied through the continued monitoring of the voltage described in Waugh because the changes described necessarily happen during the breakdown event as the pore is formed (See [0028] and Fig. 8), upon which the voltage is stopped in Waugh. Waugh further shows the voltage exceeding the threshold voltage up[on formation of the nanopore (Fig. 5b far right side of the graph).
As to claims 14 and 15, Waugh discloses the thickness of the SiNx membranes at approximately 10 nm (pg. 132 “Critical” identification) with a breakdown voltage of approximately 10 V (pg. 137 step 58) which amounts to the voltage/thickness to be approximately 1 V/nm which falls within the instantly claimed range.
As to claim 16, the phrase “wherein the predetermined voltage threshold is 0 V or more and {the first voltage x a capacitance of the capacitor/(a capacitance between the first and second electrodes across the membrane + the capacitance of the capacitor) - 10 mV} or less.” Does not further limit the instant claimed voltage because said recitation is merely a mathematical representation of the threshold voltage without particular explicit application of calculation step integrated into the method as claimed. Thus, the phrase is deemed to be descriptive of the voltage while not limiting as to the value of the voltage.
As to claim 17, Waugh discloses wherein the predetermined voltage threshold is more than 0 V and less than or equal to the first voltage - 10 mV. (Fig. 5b where the voltage threshold is shown below the voltage line and less than 10 V).
As to claim 18, Waugh discloses a pore forming apparatus (Fig. 2) comprising:
a membrane (Fig. 2 “chip”) disposed between a first electrolyte solution and a second electrolyte solution (Fig. 2 “flow channel” on each side of the chip that connects to the hole in the gasket);
a first electrode disposed to be in contact with the first electrolyte solution and a second electrode disposed to be in contact with the second electrolyte solution (Fig. 2 “electrode”);
a wiring connecting the first electrode and the second electrode (Circuit diagram which necessarily required wiring in order to connect the electrical circuit);
a voltage source that is disposed in the wiring and outputs a first voltage (Fig. 5 “voltage source” and Fig. 2 “applied voltage” which necessarily requires a source to apply the voltage)
a capacitor disposed in the wiring (Fig. 2c AND supplementary information S20 circuit diagram with 47µF capacitor);
a voltmeter that measures a second voltage between the first electrode and the second electrode (in order to monitor the voltage a voltmeter is necessarily required pg. 133 “The fabrication electronic circuit is simple and consists of a dedicated, low-bandwidth (4-kHz) transimpedance current amplifier circuit for each chip mounted, each with three independent sections. The first section doubles the input command voltage controlled by the DAQ card (maximum analog output (AO) of ±10 V), allowing voltages up to ±20 V to be applied, provided that sufficient power is supplied to the op-amps. The second section amplifies the resulting current and converts it to a voltage signal before filtering at 4 kHz using an analog 4-pole low-pass Bessel filter. The third section divides the applied voltage by 10 to bring it back to within the dynamic range of the analog inputs (AIs) of the NI DAQ (±10 V) such that it can be recorded and compared with the
desired applied voltage.”); and
a control unit that detects a significant change in the second voltage and stops output of the first voltage in response to detecting the significant change in the second voltage (the “DAQ” above coupled to the software on the computer in the citation above, “e DAQ card is turned on and connected to the computer, and press the dropdown arrow for each of the three fields, Voltage-Out (voltage applied), Voltage-In (voltage read), and Current-In (current read), i to select the correct AOs and AIs connected to the Circuit” pg. 134., carrying out the method above Fig. 5 panel B showing the monitored voltage and threshold line thus necessary detecting the significant change pg. 129 “the rapid drop of the applied voltage to zero”).
Waugh fails to explicitly disclose a switch.
Feng discloses using a switch to turn of the pore forming voltage one a voltage exceeds a threshold value ([0088]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have used a switch as taught by Feng in the circuit of Waugh because it allows for the switching off the voltage once the pore has been formed (Feng [0088]).
As to claim 19, 20 and the recitation of “wherein the change in the second voltage comprises a change rate of the second voltage that exceeds a predetermined change rate threshold such that the membrane has a voltage value greater than a predetermined threshold voltage” in instant claim 1, the type of change, i.e. an arbitrary predetermined voltage threshold and a change rate, are inherently satisfied through the continued monitoring of the voltage described in Waugh because the changes described necessarily happen during the breakdown event as the pore is formed (See [0028] and Fig. 8), upon which the voltage is stopped in Waugh. Waugh further shows the voltage exceeding the threshold voltage up[on formation of the nanopore (Fig. 5b far right side of the graph).
Claims 1-3 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Feng et al (US 2018/0073161 A1) in view of Xie et al (US 2018/0141007 A1) and Arcadia et al (Arcadia, Christopher E., Carlos C. Reyes, and Jacob K. Rosenstein. "In situ nanopore fabrication and single-molecule sensing with microscale liquid contacts." ACS nano 11.5 (2017): 4907-4915.).
As to claims 1-3, 6, and 7, Feng discloses a pore forming method (Title) comprising:
disposing a membrane (Fig. 10D # 402) between a first electrolyte solution (Fig. 10D # 408) and a second electrolyte solution (Fig. 10D # 410);
bringing a first electrode into contact with the first electrolyte solution (Fig. 10D # 412) and a second electrode into contact with the second electrolyte solution (Fig. 10D # 414);
outputting a first voltage from a voltage source to a circuit configured by disposing the voltage source.( [0157]-[01058]).
Feng fails to explicitly disclose a resistor in a wiring connecting the first electrode and the second electrode.
Xi discloses forming nanopores in a dielectric membrane via dielectric breakdown (Title) which includes a current limiting resistor in a wiring connecting the first electrode and the second electrode. (#46 Fig. 13 [0075]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have used a current limiting resistor as taught by Xi in the electrical circuit of Feng because it acts to reduce the voltage acting across the electrodes in proportion with the current flowing between them (Xi [0175]) which slows the rate of growth of the aperture and thus a great control over the diameter of the aperture than simply comparing a measured current flow (Xi [0076]). Feng further discloses wherein the resistor has a resistance value larger than a resistance of the first electrolyte solution and a resistance of the second electrolyte solution and less than or equal to 100 GΩ (as required by instant claim 6 [0075]).
Feng, as modified by Xi, fails to explicitly disclose measuring a second voltage between the first electrode and the second electrode; detecting a significant change in the second voltage; and stopping output of the first voltage in response to detecting the significant change in the second voltage.
Arcadia discloses forming a nanopore through application of a breakdown voltage (Abstract pg. 4909 “Nanopore fabrication” section) which determines that a nanopore is formed via measuring a second voltage between the first electrode and the second electrode; detecting a significant change in the second voltage; and stopping output of the first voltage in response to detecting the significant change in the second voltage. (See Fig. 4A “After the initial charging period, we observe a gradual increase in voltage (less than 300 mV/s), which we attribute to the slower accumulation of charge into traps or defects in the dielectric material. Eventually, some of these traps align to form a dominant localized path of lower resistance for leakage current. Presumably, the resulting joule heating causes the membrane to fail forming a nanoscale pore. This abruptly increases the conductance of the membrane, which causes a rapid drop in voltage (>100 V/s). Figure 4a shows a representative breakdown event.”).
Arcadia further discloses the following dependent claim limitations:
Instant claim 2: the change is below a predetermined voltage (Fig. 4 once it starts to drop thus showing an inherent threshold)
Instant claim 1: the change exceeds a rate threshold (pg. 4910 col. 1 “rapid drop in voltage”)
Instant claim 7: wherein the predetermined voltage threshold is more than 0 V and less than or equal to the first voltage - 10 mV. (Fig. 4 where the first voltage is the breakdown voltage applied).
Thus, it would have been obvious to one of ordinary skill in the art to have measures a second voltage, detecting a change, and stopping output as taught by Arcadia in the method of Fend, as modified by Xi, because such a measurement is self limiting because one the nanopore forms, the electric field automatically reduces which reduces formation time and limiting the risk of runaway growth (Arcadia pg. 4909 col. 2 last 2 paragraphs).
As to claims 8-10, Feng discloses a pore forming apparatus (Title) comprising:
a membrane (Fig. 10D # 402) disposed between a first electrolyte solution (Fig. 10D #408) and a second electrolyte solution (Fig. 10D # 410);
a first electrode disposed to be in contact with the first electrolyte solution (Fig. 10D # 412);
a second electrode disposed to be in contact with the second electrolyte solution (Fig. 10D # 414);3
a wiring connecting the first electrode and the second electrode (Fig. 10D # 420 wiring connections between 420 and 412/414);
a voltage source that is disposed in the wiring and outputs a first voltage (Fig. 10D # 420);
Feng fails to explicitly disclose a resistor in a wiring connecting the first electrode and the second electrode.
Xi discloses forming nanopores in a dielectric membrane via dielectric breakdown (Title) which includes a current limiting resistor in a wiring connecting the first electrode and the second electrode. (#46 Fig. 13 [0075]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have used a current limiting resistor as taught by Xi in the electrical circuit of Feng because it acts to reduce the voltage acting across the electrodes in proportion with the current flowing between them (Xi [0175]) which slows the rate of growth of the aperture and thus a great control over the diameter of the aperture than simply comparing a measured current flow (Xi [0076]). Feng further discloses wherein the resistor has a resistance value larger than a resistance of the first electrolyte solution and a resistance of the second electrolyte solution and less than or equal to 100 GΩ (as required by instant claim 6 [0075]).
Feng, as modified by Xi, fails to explicitly disclose a voltmeter that measures a second voltage between the first electrode and the second electrode; and a control unit that detects a significant change in the second voltage and stops output of the first voltage in response to detecting the significant change in the second voltage.
Arcadia discloses forming a nanopore through application of a breakdown voltage (Abstract pg. 4909 “Nanopore fabrication” section) which determines that a nanopore is formed via measuring a second voltage between the first electrode and the second electrode; detecting a significant change in the second voltage; and stopping output of the first voltage in response to detecting the significant change in the second voltage. (See Fig. 4A “After the initial charging period, we observe a gradual increase in voltage (less than 300 mV/s), which we attribute to the slower accumulation of charge into traps or defects in the dielectric material. Eventually, some of these traps align to form a dominant localized path of lower resistance for leakage current. Presumably, the resulting joule heating causes the membrane to fail forming a nanoscale pore. This abruptly increases the conductance of the membrane, which causes a rapid drop in voltage (>100 V/s). Figure 4a shows a representative breakdown event.”).
Arcadia further discloses the following dependent claim limitations:
Instant claim 9: the change is below a predetermined voltage (Fig. 4 once it starts to drop thus showing an inherent threshold0
Instant claim 10: the change exceeds a rate threshold (pg. 4910 col. 1 “rapid drop in voltage”)
Thus, it would have been obvious to one of ordinary skill in the art to have measures a second voltage, detecting a change, and stopping output as taught by Arcadia in the method of Fend, as modified by Xi, because such a measurement is self-limiting because one the nanopore forms, the electric field automatically reduces which reduces formation time and limiting the risk of runaway growth (Arcadia pg. 4909 col. 2 last 2 paragraphs).
Response to Arguments
Applicant's arguments filed 25 June 2026 have been fully considered but they are not persuasive.
Applicant's arguments are not persuasive because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. Applicant's arguments amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LOUIS J RUFO whose telephone number is (571)270-7716. The examiner can normally be reached Monday to Friday, 9 am to 5 pm.
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/LOUIS J RUFO/Primary Examiner, Art Unit 1795
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