Office Action Predictor
Application No. 18/062,966

NANOELECTRIC DEVICES AND USE THEREOF

Final Rejection §102§103§112
Filed
Dec 07, 2022
Examiner
KIM, YOUNG J
Art Unit
1681
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Twist Bioscience Corporation
OA Round
2 (Final)
65%
Grant Probability
Moderate
3-4
OA Rounds
3y 4m
To Grant
77%
With Interview

Examiner Intelligence

65%
Career Allow Rate
708 granted / 1095 resolved
Without
With
+12.5%
Interview Lift
avg trend
3y 4m
Avg Prosecution
60 pending
1155
Total Applications
career history

Statute-Specific Performance

§101
5.0%
-35.0% vs TC avg
§103
32.5%
-7.5% vs TC avg
§102
16.5%
-23.5% vs TC avg
§112
33.7%
-6.3% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§102 §103 §112
DETAILED ACTION The present Office Action is responsive to the Amendment received on November 11, 2025. Preliminary Remark Claims 3, 4, 8-10, 13-45, 47, 49, 53, 54, 57-62, 65-84, and 86-213 are canceled. Claims 215 and 216 are new. Claim Objections The objection to claim 1 for reasons discussed in the Office Action mailed on July 8, 2025 is withdrawn in view of the Amendment received on November 10, 2025. Claim Rejections - 35 USC § 112 The rejection of claims 12, 50, 55, 56, and 85 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter, made in the Office Action mailed on July 8, 2025 is withdrawn in view of the Amendment received on November 10, 2025. Claim Rejections - 35 USC § 102 The rejection of claims 1, 2, 5-7, and 11-13 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Jin et al. (WO 2021/134070 A1, published July 2021, priority December 2019), made in the Office Action mailed on July 8, 2025 is withdrawn in view of the Amendment received on November 10, 2025. Claim Rejections - 35 USC § 103 The rejection of claims 46 and 48-50 under 35 U.S.C. 103 as being unpatentable over Jin et al. (WO 2021/134070 A1, published July 2021, priority December 2019) in view of Premanode et al. (Sensors and Actuators B, 2007, vol. 120, pages 732-735), made in the Office Action mailed on July 8, 2025 is withdrawn in view of the Amendment received on November 10, 2025. The rejection of claim 54 under 35 U.S.C. 103 as being unpatentable over Hoffman et al. (US 2017/0018626 A1, published January 19, 2017) in view of Merriman et al. (US 2020/0277645 A1, published September 2020, priority April 2017), made in the Office Action mailed on July 8, 2025 is withdrawn in view of the Amendment received on November 10, 2025, by its cellation. Rejection - Maintained 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 rejection of claims 51 and 56 under 35 U.S.C. 103 as being unpatentable over Hoffman et al. (US 2017/0018626 A1, published January 19, 2017) in view of Merriman et al. (US 2020/0277645 A1, published September 2020, priority April 2017), made in the Office Action mailed on July 8, 2025 is maintained for the reasons of record. Applicants’ amendment/arguments presented in the Amendment received on November 10, 2025 have been carefully considered but they have not been found persuasive for the reasons discussed on the, “Response to Arguments” section. The Rejection: With regard to claim 51, Hoffman et al. teach the below reproduced device (from Fig. 5E): PNG media_image1.png 347 885 media_image1.png Greyscale As seen, the disclosed device comprises a solid support (i.e., substrate), wherein the solid support comprises a plurality of loci (see each reaction area), wherein each loci comprises: a) a graphene layer (see graphene layer on top, see also Fig. 5D where a layer of graphene exists above the SiO2 substrate); a source electrode and a drain electrode (see Fig. 5D); and at least one insulating layer, where the insulating layer is located between the gain electrode and the drain electrode (“a source electrode and a drain electrode together forming a gate … the FET may also include an insulating barrier separating the gate from the channel”, section [0015]), wherein the loci have a pitch of 50-100 nanometers (“length of the channel from the source to the drain ranges is less than 1 micron, such as less than 500 nm, including less than 50 nm … may be 20 nm or less”, section [0198]). With regard to claim 56, the graphene layer is about one atom thick (“graphene FET”, section [0031]1) Hoffman et al. also teach that their sensor is employed to “facilitate DNA hybridization and/or sequencing techniques, such as based on monitoring changes … binding events associated with chemical processes (e.g., relating to DNA synthesis), such as within a gated reaction chamber or wells of the gFET based sensor”, section [0032]). Hoffman et al. do not explicitly teach that their sensor comprises a gate electrode and a drain electrode is provided, wherein an insulating layer is located between the gate and the drain electrode. While Hoffman et al. explicitly teach that for gFET sensors, CMOS structure is provided and at least a first insulating layer is configured so as to one or more of necessary structures therein (section [0033]), the artisans do not explicitly teach that their sensor comprise at least one buried gate (claim 54). Merriman et al. teach a FET sensor which comprises a structure similar to that of Hoffman et al., wherein a pair of electrodes are separated by a gap, with an embodiment directed having a graphene layer (see Fig. 1, also, “a molecular sensor comprising an enzyme-based molecular circuit … having a polymerase enzyme is usable to sense sequence information from the DNA template processed by the polymerase”, section [0006]; “the at least one arm molecule may be selected from … a graphene-like nanoribbon”, section [0010]; “such arms may comprise … graphene nanoribbons”, section [0064]). Merriman et al. also teach a well-known means of employing gate electrodes as well as source/drain electrodes, and buried gate in an electrochemical sensor: “a molecular circuit comprises: a positive electrode; a negative electrode spaced apart from the positive electrode; and an enzyme connected to both the positive and negative electrodes to form a conductive pathway between the positive and negative electrodes … this circuit further comprises a gate electrode” (sections [0025] and [0026]) “A pair of spaced apart electrodes herein may comprise a source and drain electrode pair … a binding probe-based molecular circuit may further comprise a gate electrode. When present, a gate electrode is used to apply a voltage … A gate electrode will be electrically isolated [i.e., insulated] from the primary conduction path of the circuit by some form of insulating layer or material” (section [0052]) “the molecular sensor circuit comprises more than two arums … Such arm may connect to additional electrodes in the system comprising more than two electrodes, including the case of a system with a gate electrode, such as a buried gate electrode …”, section [0070]) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Hoffman et al. with the teachings of Merriman et al., thereby arriving at the invention as claimed for the following reasons. In KSR, the Supreme Court particularly emphasized “the need for caution in granting a patent based on the combination of elements found in the prior art,” Id. at 415, 82 USPQ2d at 1395, and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 415-16, 82 USPQ2d at 1395. The Supreme Court stated that there are “[t]hree cases decided after Graham [that] illustrate this doctrine.” Id. at 416, 82 USPQ2d at 1395. (1) “In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” As discussed above, both Hoffman et al. and Merriman et al. teach a sensor comprising a plurality of pairs of electrodes which are separated with graphene layer, wherein the sensor is used for detection purposes. While Hoffman et al. did not explicitly list all possible types of configurations that can be employed, such as having a gate electrode, and buried electrode, as evidenced by Hoffman et al. such configurations were known in the art, yielding the same predictable outcome of providing a detectable signal of the sensor. Therefore, combining features of the prior art which yielded the same predictable outcome would have been well-within the purview of the ordinarily skilled artisan, and obvious to one of ordinary skill in the art. In addition, the specification of instant application does not provide any specific advantages of having such a configuration, also evidencing that the configuration does not amount to any advantage or improvement other than incorporating features that yield the same predictable outcome. Therefore, the invention as claimed is deemed prima facie obvious over the cited references. Response to Arguments: Applicants state that claims 1 and 51 have been amended and that claim 51 now recites a solid support comprising a graphene layer, where the graphene layer is configured to be removably attached to a ternary complex such that the ternary complex can be removed from the graphene layer (page 9, Response). This argument had been found persuasive for claim 1, but not for claim 51. Claim 51 does not even actively require the presence of a ternary complex. Rather, the graphene layer is configured to be removably attached to the ternary complex. Since the graphene layer of Hoffman et al. can be reversibly bound to nucleic acids in general (released via pH change, wash buffer, heating, etc.) since the claim does not actively require the ternary complex formed among the biomolecule, primer and the molecular sensor, the graphene layer is configured as such. Therefore, the rejection is maintained. The rejection of claims 52 and 55 under 35 U.S.C. 103 as being unpatentable over Hoffman et al. (US 2017/0018626 A1, published January 19, 2017) in view of Merriman et al. (US 2020/0277645 A1, published September 2020, priority April 2017), as applied to claims 51, 54, and 56 above, and further in view of Hebert et al. (U.S. Patent No. 6,107,160, issued August 2000),made in the Office Action mailed on July 8, 2025 is maintained for the reasons of record. Applicants do not present any arguments for the instant rejection in the Amendment received on November 10, 2025, but rely solely on their argument presented for the rejection over claims 51 and 56, which have not been found persuasive for the reasons discussed above. The rejection is maintained for the reasons of record therefore. The rejection: The teachings of Hoffman et al. and Merriman et al. have already been discussed above. Hoffman et al. and Merriman et al. do not explicitly teach that their sensor comprises at least one ground shield which permits electrical communication between the graphene layer and the at least one buried gate. Hebert et al. the use of buried shield plate between a gate and drain of a field effect transistor that can reduce gate to drain capacitance and maximizes frequency response of any FET-type device (column 1, bottom paragraph to column 2, 1st paragraph). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Hoffman et al. and Merriman et al. with the teachings of Hebert et al., thereby arriving at the invention as claimed because one of ordinary skill in the art would have recognized the many benefits in reducing gate to drain capacitance of an FET sensor, one of which would be the enhance signal integrity. Given that Hebert et al. explicitly stated that shield plate (also knowns as ground shield) can be applicable to most FET sensors, one of ordinary skill in the art would have had a reasonable expectation of success at applying the teachings of Hebert et al. to the FET sensor of Hoffman et al. Therefore, the invention as claimed is deemed prima facie obvious over the cited references. Rejection – New Grounds, Necessitated by Amendment Claim 216 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffman et al. (US 2017/0018626 A1, published January 19, 2017) in view of Merriman et al. (US 2020/0277645 A1, published September 2020, priority April 2017). Claim 216 depends from claim 51. The present rejection relies on the discussion relating to claim 51 above. As it regards to claim 216, Hoffman et al. already teach that their device’s sensor function is based on an amount of current that passes through from the gate electrode to the drain electrode (“the computer component of the FET, e.g., CMOS … performance of one or more reactions involving a biological or chemical material so as to obtain reaction results … based on detecting and/or measuring changes in voltage (V) potential, current (I) … on the chemically sensitive field effective transistor.” (section [0045]) Whether the current is detected from the property of the “ternary complex” is not relevant to the product claim herein as the claimed device does not contain a ternary complex, and the device is already configured to detect based on current changes. Based on this teaching of Hoffman et al., the rationale of obvious is adopted from the rationale already discussed above. Conclusion Claims 1, 2, 5-7, 11, 12, 46, 48, 50, 63, 64, 85, 214, and 215 are allowable. Claims 51, 52, 55, 56, and 216 are rejected. 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. Inquiries Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7:30 a.m. to 4:00 p.m (M-F). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782. Papers related to this application may be submitted to Art Unit 1681 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /YOUNG J KIM/Primary Examiner Art Unit 1637 February 9, 2026 /YJK/ 1 Jin et al. (of record) already demonstrates that graphene based later is one atom thick, “It should be noted that the monolayers of TMD materials are not just one atom thick as graphene”, section [0015].
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Prosecution Timeline

Dec 07, 2022
Application Filed
Jul 01, 2025
Examiner Interview (Telephonic)
Jul 04, 2025
Non-Final Rejection — §102, §103, §112
Nov 10, 2025
Response Filed
Feb 09, 2026
Final Rejection — §102, §103, §112
Apr 03, 2026
Response after Non-Final Action

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Prosecution Projections

3-4
Expected OA Rounds
65%
Grant Probability
77%
With Interview (+12.5%)
3y 4m
Median Time to Grant
Moderate
PTA Risk
Based on 1095 resolved cases by this examiner