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 .
Response to Amendment
Acknowledgment is made that applicant's Amendment, filed on July 15th, 2026, has been entered.
Upon entrance of the Amendment, claims 1, 6, 7, 14, and 16 were amended, claims 21-25 were added, claims 3, 8, 11, 19, and 20 were cancelled. Claims 1, 2, 4-7, 9, 10, 12-18, and 21-25 are currently pending.
The rejection of claims 12 and 14 under 35 U.S.C. § 112(b) have been withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim 1have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1-2, 4, 6-7, 9-10, 12-13, 15-16, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu (U.S. Patent No. 9,377,432) in view of Bedell et al. (U.S. Patent No. 8,828,138).
Regarding to claim 1, Zhu teaches nanopore sensing device, comprising:
a nanopore having a first orifice (Fig. 3, element 108) and second orifice (Fig. 3, hole 118), and a length running from the first to the second orifice (Fig. 3); and
two or more sensors for sensing an electric feature in the nanopore (Fig. 3, elements 110A, 110B… 110N);
wherein the nanopore sensing device comprises a plurality of sensing layers arranged along the length, wherein each sensing layer is part of one of the sensors (Fig. 3, column 3, lines 41-44), wherein each adjacent pair of sensing layers is separated by a respective isolating insulating layer (Fig. 3, elements 112A, 112B…).
Zhu does not disclose at least one of the sensors is a field-effect transistor.
Bedell discloses at least one of the sensors is a field-effect transistor (Fig. 7, one FET of the FET STACK 205). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zhu in view of Bedell to configure at least one of the sensors to be a field-effect transistor in order to detect various types of biomolecules without requiring a sensing surface covered with a biological coating to bind the biomolecules (Bedell, column 3, lines 9-11).
Regarding to claim 2, Bedell discloses the field-effect transistor has a subthreshold swing at room temperature that is less than or equal to 150 mV/dec (column 7, lines 1-2).
Regarding to claim 4, Bedell discloses the field-effect transistor is at least one of a nanopore field-effect transistor or an extended-gate field-effect transistor (Fig. 7).
Regarding to claim 6, Zhu discloses at least one of the sensors is a conductive sensor that has a sensing layer that comprises a conductor layer configured such that a resistance of the conductor layer is modulated by the contents of the electric feature in the nanopore (Fig. 3; column 6, lines 40-44).
Regarding to claim 7, Zhu discloses the insulating layers have respective thicknesses between 2 nm and 100 nm (column 5, lines 11-13).
Regarding to claim 9, Zhu discloses the nanopore has a section defined between an uppermost sensing layer and a lowermost sensing layer of the sensing layers, wherein the section has a substantially constant width and substantially uniform sidewalls (Fig. 3).
Regarding to claim 10, Zhu discloses the nanopore has a width above the uppermost sensing layer or below the lowermost sensing layer that is increased relative to the width of the nanopore between the uppermost sensing layer and the lowermost sensing layer (Fig. 3).
Regarding to claim 12, Zhu as modified is silent about the sensitivity of the device. However, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to configure a signal-to-noise ratio of at least 0 dB up to at least 100 kHz in order to increase sensitivity, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Regarding to claim 13, Zhu discloses a system comprising: the nanopore sensing device of claim 1 and a microfluidic system coupled to the nanopore of the sensing device (column 1, lines 23-27).
Regarding to claim 15, Zhu discloses the nanopore has a section defined between an uppermost sensing layer and a lowermost sensing layer of the sensing layers of the nanopore sensing device, wherein the section has a substantially constant width and substantially uniform sidewalls (Fig. 3).
Regarding to claim 16, Zhu discloses the nanopore has a width above the uppermost sensing layer or below the lowermost sensing layer that is increased relative to the width of the nanopore between the uppermost sensing layer and the lowermost sensing layer (Fig. 3, please look up-side down).
Regarding to claim 23, Zhu discloses at least one of the sensors is a conductive sensor that has a sensing layer that comprises a conductor layer configured such that a resistance of the conductor layer is modulated by the contents of the electric feature in the nanopore (Fig. 3; column 6, lines 40-44).
Regarding to claim 24, Zhu as modified discloses an oxide that lines the nanopore such that (i) the oxide separates, from contents of the nanopore, a sensing layer of at least one of the sensors that is a field-effect transistor and (ii) the oxide does not separate, from contents of the nanopore, the conductor layer of the conductive sensor (Bedell, Fig. 5, element 502).
Regarding to claim 25, Zhu as modified discloses an oxide that lines the nanopore such that (i) the oxide separates, from contents of the nanopore, a sensing layer of at least one of the sensors that is a field-effect transistor and (ii) the oxide does not separate, from contents of the nanopore, the conductor layer of the conductive sensor (Bedell, Fig. 5, element 502).
Allowable Subject Matter
Claims 5, 14, 17-18, and 21-22 are 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. The following is a statement of reasons for the indication of allowable subject matter:
Regarding to claim 5, the prior art fails to anticipate or render obvious the claimed limitations including “at least two of the sensing layers have one or two contacts in common” in combination with the limitation recited in claim 1.
Regarding to claim 14, the prior art fails to anticipate or render obvious the claimed limitations including “the microfluidic system comprises a cis reservoir and a trans reservoir; and wherein the system further comprises a cis electrode and a trans electrode that are configured to generate a potential difference between the cis reservoir and the trans reservoir to translocate an analyte through the nanopore” in combination with the limitation recited in claim 1 and claim 13.
Regarding to claim 17, the prior art fails to anticipate or render obvious the claimed limitations including “A method for sensing an analyte, comprising: providing an analyte in the nanopore sensing device of claim 1; translocating the analyte through the nanopore of the nanopore sensing device; and sensing an electric feature of the nanopore as the analyte translocates therethrough” in combination with the limitation recited in claim 1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/VU A VU/Primary Examiner, Art Unit 2897
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