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 .
Election/Restrictions
Applicant’s election without traverse of group I comprising claims 1 – 14 in the reply filed on 1/20/2026 is acknowledged.
Claims 15 – 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/20/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the each of the recited features of the claimed system must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 6 is objected to because of the following informalities: Claim 6 should read “a single protease nanopore” for a single nanopore, instead of nanopores. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Claim 13 should read “a single protease nanopore” for a single nanopore, instead of nanopores. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 – 5 and 8 – 12 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Rosenstein et al. (WO 2012/116161 A1; hereinafter “Rosenstein”).
Regarding claim 1, Rosenstein teaches a system apparatus structure (pages 14 and 15; figures 18 and 19) comprising:
a cavity (the top volume connecting the two V-shaped well structures each comprising a nanopore at their respective bottom);
a plurality of nanopores (two nanopores at the bottom of each of the two V-shaped well structures) separated by the cavity; and
a plurality of electrolyte reservoirs (the two V-shaped well structures each comprising a nanopore at their respective bottom, and capable of holding an electrolyte), each of the reservoirs being provided (i) on a side of a respective one of the nanopores, and (ii) within the cavity.
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Regarding claim 2, Rosenstein teaches the system of claim 1, wherein at least one of the nanopores is fabricated with two-dimensional materials (e.g., a silicon nitride membrane; pages 14 – 16).
Regarding claim 3, Rosenstein teaches the system of claim 1, wherein at least one of the nanopores is fabricated in a silicon nitride membrane (e.g., a silicon nitride membrane; pages 14 – 16).
Regarding claim 4, Rosenstein teaches the system of claim 1, wherein the particular ones of the reservoirs provided on the sides nanopores are denoted as a cis chamber and a trans chamber, respectively (figure 19; see also figure 5A).
Regarding claim 5, Rosenstein teaches the system of claim 1, further comprising a nanowell positioned at one of entrances of at least one of the nanopores (the two V-shaped well structures each comprising a nanopore at their respective bottom; figure 19).
Regarding claim 8, Rosenstein teaches a complementary metal-oxide-semiconductor (CMOS) integrated circuit, comprising:
a plurality of systems for detecting a molecular size and a molecular charge, at least one of the systems comprising:
a cavity (the top volume connecting the two V-shaped well structures each comprising a nanopore at their respective bottom),
a plurality of nanopores separated by the cavity (two nanopores at the bottom of each of the two V-shaped well structures), and
a plurality of electrolyte reservoirs, each of the reservoirs being provided (i) on a side of a respective one of the nanopores, and (ii) within the cavity (the two V-shaped well structures each comprising a nanopore at their respective bottom, and capable of holding an electrolyte), wherein the systems are integrated onto a surface of the circuit (page 8); and
a plurality of transimpedance amplifiers (page 2) configured to measure a conductance through the nanopores.
Regarding claim 9, Rosenstein teaches the CMOS integrated circuit of claim 8, wherein at least one of the nanopores is fabricated with two-dimensional materials (e.g., a silicon nitride membrane; pages 14 – 16).
Regarding claim 10, Rosenstein teaches the CMOS integrated circuit of claim 8, wherein at least one of the nanopores is fabricated in a silicon nitride membrane (e.g., a silicon nitride membrane; pages 14 – 16).
Regarding claim 11, Rosenstein teaches the CMOS integrated circuit of claim 8, wherein the particular ones of the reservoirs provided on the sides nanopores are denoted as a cis chamber and a trans chamber, respectively (figure 19; see also figure 5A).
Regarding claim 12, Rosenstein teaches the CMOS integrated circuit of claim 8, wherein the at least one of the systems comprises a nanowell positioned at one of entrances of at least one of the nanopores (the two V-shaped well structures each comprising a nanopore at their respective bottom; figure 19).
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.
Claim(s) 6, 7, 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenstein et al. (WO 2012/116161 A1; hereinafter “Rosenstein”) in view of Guan et al. (US 2015/0259724 A1; hereinafter “Guan”).
Regarding claim 6, Rosenstein does not specifically teach the system of claim 1, further comprising a single protease nanopore.
However, Guan teaches a sensing apparatus comprising a single protease nanopore for sensing (e.g., paragraphs 9 – 11). The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a single protease nanopore for the disclosed apparatus.
Regarding claim 7, Rosenstein does not specifically teach the system of claim 1, further comprising a plurality of proteases positioned in a well.
However, Guan teaches a sensing apparatus comprising a plurality of proteases positioned in a well for sensing (e.g., paragraphs 9 – 11). The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a plurality of proteases positioned in a well for the disclosed apparatus.
Regarding claim 13, Rosenstein teaches the CMOS integrated circuit of claim 8, wherein the at least one of the systems comprises a single protease nanopore.
However, Guan teaches a sensing apparatus comprising a single protease nanopore for sensing (e.g., paragraphs 9 – 11). The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a single protease nanopore for the disclosed apparatus.
Regarding claim 14, Rosenstein teaches the CMOS integrated circuit of claim 8, wherein the at least one of the systems comprises a plurality of proteases positioned in a well.
However, Guan teaches a sensing apparatus comprising a plurality of proteases positioned in a well for sensing (e.g., paragraphs 9 – 11). The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a plurality of proteases positioned in a well for the disclosed apparatus.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth A Robinson can be reached at (571) 272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796