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 .
The preliminary amendment filed June 29, 2026, canceling claims 3, 6-8, 11, 17, 22 and amending claims 1-2, 16, 20, 25-26 is acknowledged and has been entered. Claims 1-2, 4-5, 9-10, 12-16, 18-21, 23-27 are pending and will be examined.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-2, 4-5, 7-10, 12-16 and 18-21 in the reply filed on June 29, 2026 is acknowledged.
Claims 23-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 June 29, 2026.
Claims 1-2, 4-5, 7-10, 12-16 and 18-21 are pending and will be examined.
Specification – embedded hyperlink
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
See paragraphs 141, 187 and 468 where embedded hyperlinks are included.
Correction is required.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 11, 2023, January 8, 2025 and May 7, 2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(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) 1-2, 4-5, 7-10, 12-16 and 18-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stranges et al. (PNAS, 2016, 113(44):E6749-E6756).
With regard to claim 1, Stranges teaches a system for characterizing a target analyte, comprising:
a nanopore;
and a polymer strand comprising a tether site and a reaction section, wherein the polymer strand is tethered via the tether site so that the polymer strand cannot pass through the nanopore, and wherein the reaction section comprises at least one sensing module which can interact with a single molecule of the target analyte (Abstract, Fig 3, especially Fig 3D, where a polymerase-template is attached to, or tethered to the pore).
With regard to claim 2, Stranges teaches a system according to claim 1, wherein the reaction section comprises two or more sensing modules which can interact with two or more different target analytes, and wherein each sensing module consists of one, two or more sensing moieties and each sensing moiety can interact with one or two or more binding sites of a single molecule of the target analyte (Abstract, Fig 3, especially Fig 3D, where a polymerase-template is attached to, or tethered to the pore).
With regard to claim 4, Stranges teaches a system according to claim 2, wherein the sensing moiety is selected from the group consisting of base of any nucleotide, any amino acid, 1,2,3-trizole, phenylboronic acid (PBA) or any combination thereof (Abstract, Fig 3, especially Fig 3D, where a polymerase-template is attached to, or tethered to the pore).
With regard to claim 5, Stranges teaches a system according to claim 1, wherein at least one of the sensing modules consists of two neighbouring purines selected from the group consisting of guanine and adenine (Abstract, Fig 3, especially Fig 3D, where a polymerase-template is attached to, or tethered to the pore).
With regard to claim 9, Stranges teaches a system according to claim 1, wherein the polymer strand is tethered to a stopper molecule or the nanopore protein (Abstract, Fig 3, especially Fig 3D, where a polymerase-template is attached to, or tethered to the pore).
With regard to claim 10, Stranges teaches a system according to claim 9, wherein the stopper molecule is a protein which can specifically bind a small molecule compound, the tether site comprises the small molecule compound, and the polymer strand is tethered to the stopper molecule through the specific binding of the small molecule compound to the protein; or the stopper molecule is streptavidin or an antibody of a hapten and the small molecule compound is biotin or the hapten (Abstract, Fig 3, especially Fig 3D, where a polymerase-template is attached to, or tethered to the pore).
With regard to claim 12, Stranges teaches a system according to claim 9, wherein the tether site comprises a small molecule that can react with a natural amino acid on the surface of the stopper molecule or the nanopore protein, and the polymer strand is tethered to the stopper molecule through the reaction between the small molecule compound and the natural amino acid (Abstract, Fig 3, especially Fig 3D, where a polymerase-template is attached to, or tethered to the pore).
With regard to claim 13, Stranges teaches a system according to claim 9, wherein a first reactive handle is introduced to the surface of the stopper molecule or the nanopore protein, the tether site comprises a second reactive handle, and the polymer strand is tethered to the stopper molecule through the reaction between the first reactive handle and the second reactive handle (Abstract, Fig 3, especially Fig 3D, where a polymerase-template is attached to, or tethered to the pore).
With regard to claim 14, Stranges teaches a system according to claim 1, wherein the polymer strand further comprises an extension section and the extension section is configured to enable the reaction section to be located in a region suitable for measurement of a blockage (Abstract, Fig 3, especially Fig 3D, where a polymerase-template is attached to, or tethered to the pore).
With regard to claim 15, Stranges teaches a system according to claim 1, wherein the polymer strand further comprises a traction section and the traction section is configured to hold the reaction section in a region suitable for measurement of a blockage (Abstract, Fig 3, especially Fig 3D, where a polymerase-template is attached to, or tethered to the pore).
With regard to claim 16, Stranges teaches a system according to claim 15, wherein the traction section comprises any one of the following: a. a polymer chain which tend to pass through the nanopore channel in the electric field applied to the nanopore; b. a coupling site which can react with a natural amino acid on the surface of the channel of the nanopore; c. a second reactive handle which can react with a first reactive handle introduced to the surface of the channel of the nanopore; or d. a polymer chain that can pass through the channel of the nanopore and form a three- dimension structure outside the nanopore which has a size larger than the exit opening of the nanopore (Abstract, Fig 3, especially Fig 3D, where a polymerase-template is attached to, or tethered to the pore).
With regard to claim 18, Stranges teaches a system according to claim 1, wherein the polymer strand is based on nucleic acid, nucleic acid analog, polypeptide, polysaccharide, a homopolymer, a copolymer, or any combination thereof (Abstract, Fig 3, especially Fig 3D, where a polymerase-template is attached to, or tethered to the pore).
With regard to claim 19, Stranges teaches a system according to claim 1, wherein the target analyte is selected from the group consisting of: ion comprising metal element; monosaccharide; oligosaccharide; polysaccharide; glucoside; polyphenol; catecholamine; catecholamine derivative; polyol; protonated or deprotonated forms of a compound; a compound containing a ribose moiety; hydrogen peroxide; oligopeptide or cyclopeptide; buffer reagent; smaller molecular drug; neurotransmitter; compound with a specific chirality; chemical intermediate; or any combination thereof (Abstract, Fig 3, especially Fig 3D, where a polymerase-template is attached to, or tethered to the pore).
With regard to claim 20, Stranges teaches a system according to claim 1, wherein the nanopore is a biological protein nanopore, a solid nanopore or a DNA nanopore (Abstract, Fig 3, especially Fig 3D, where a polymerase-template is attached to, or tethered to the pore).
With regard to claim 21, Stranges teaches a system according to claim 20, wherein the protein nanopore is MspA, a-HL, Aerolysin, ClyA, FhuA, FraC, PlyA/B, CsgG Phi 29 connector or a homolog or variant thereof (Abstract, Fig 3, especially Fig 3D, where a polymerase-template is attached to, or tethered to the pore).
Conclusion
No claims are allowed. All claims stand rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE KANE MUMMERT whose telephone number is (571)272-8503. The examiner can normally be reached M-F 9:00-5:30.
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/STEPHANIE K MUMMERT/Primary Examiner, Art Unit 1681
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