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
Claims 15 – 18 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Response to Arguments
Applicant's arguments, filed 5/28/2026, have been fully considered but they are not persuasive. Regarding the rejection of claims 1 – 5 and 8 – 12 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Rosenstein et al. (WO 2012/116161 A1; hereinafter “Rosenstein”), Applicant alleges that Rosenstein does not anticipate the claimed apparatus. Examiner respectfully disagrees. Regarding claims 1 and 8, the Rosenstein teaches all of the positively recited structure of the apparatus as claimed. The term “electrolyte” associated with a reservoir in the claims merely indicates the function of the reservoir. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The recitation of a new intended use, for an old product, does not make a claim to that old product patentable. The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). See MPEP §§ 2114 and 2173.05(g). Furthermore, the claims still do not exclude the apparatus structure taught by the prior art.
Guan et al. (US 2015/0259724 A1; hereinafter “Guan”) merely incorporates the use of a single protease nanopore for sensing that is very well known in the art (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.
The objections to claims 6 and 13 have been withdrawn.
Applicant states in the Introduction section of the remarks that claims 5 and 22 have been canceled. However, in the amended set of claims filed, claim 5 is still indicated as “Original” and apparently not canceled. Also, there is no claim 22 present. There was no claim 22 present in the original set of claims filed 3/14/2023.
Applicant states in the Introduction section of the remarks that claim 16 was amended. However, in the amended set of claims filed, claim 16 is still indicated as “Withdrawn” and apparently not amended.
No drawings were received in the last response by Applicant. Therefore, this objection to the drawings is maintained.
Applicant added new dependent claims 19 and 20.
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.
Note Regarding Prior Art
Examiner cites particular sections, columns, line numbers, paragraphs and figures, in the references as applied to the claims below for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the Applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
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 reservoir structures, which are structurally equivalent to the recited electrolyte reservoirs (the two V-shaped well structures each comprising a nanopore at their respective bottom, and capable of holding an electrolyte) capable of holding an electrolyte or fluid, each of the reservoirs being provided (i) on a side of a respective one of the nanopores, and (ii) within the cavity.
The cited prior art teaches all of the positively recited structure of the claimed apparatus. The recitation of a new intended use, for an old product, does not make a claim to that old product patentable. The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). See MPEP §§ 2114 and 2173.05(g).
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 reservoir structures, which are structurally equivalent to the recited electrolyte reservoirs (the two V-shaped well structures each comprising a nanopore at their respective bottom, and capable of holding an electrolyte) capable of holding an electrolyte or fluid, 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.
The cited prior art teaches all of the positively recited structure of the claimed apparatus. The recitation of a new intended use, for an old product, does not make a claim to that old product patentable. The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). See MPEP §§ 2114 and 2173.05(g).
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.
Claim(s) 19 and 20 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 Caneva et al. (WO 2023/140732 A1; hereinafter “Caneva”).
Regarding claim 19, Rosenstein does not specifically teach the system of claim 1, further comprising a 2D material membrane enclosing the cavity.
Regarding claim 20, Rosenstein does not specifically teach the CMOS integrated circuit of claim 8, wherein the at least one of the systems further comprises a 2D material membrane enclosing the cavity.
However, Caneva teaches a measuring method and nanopore device utilizing a 2D material membrane, such as a rim defining a membrane nanopore (e.g., page 4, lines 14 – 30). Solid-state nanopore membranes offer the benefits of robustness, parallelization, mass reproducibility, and integration with on-chip optics and electronics (page 3, lines 6 – 10). Consequently, as evidenced by Caneva, the incorporation of a 2D material membrane for enclosing a reservoir or cavity structure win a nanopore sensing apparatus would have been considered to be suitable and predictable to a person of ordinary skill in the art. Furthermore, 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 further provide a 2D material membrane enclosing the cavity, as recited in claim 19, and wherein the at least one of the systems further comprises a 2D material membrane enclosing the cavity, as recited in claim 20.
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.
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, Lyle Alexander can be reached at (571) 272-1254. 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
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