Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 1-22 are currently pending in the instant application, filed October 12, 2026.
Response to Election/Restriction
Applicant's election of Group I without traverse, claims 1-17 directed to a method of analyzing a polynucleotide; and Applicant’s election of Species with traverse as follows:
Species (A): wherein the polynucleotide comprises DNA, RNA, PNA, or a combination thereof (claim 2),
Species (B): wherein the first charged moiety of the end domain is a charged acid or basic residue forming a cation (claim 3),
Species (C): wherein the nanopore is a solid-state nanopore, protein nanopore, a hybrid solid state-protein nanopore, etc. (claim 6),
Species (D): wherein the protein nanopore is alpha-hemolysin or Mycobacterium smegmatis porin A (claim 7), and
Species (E): wherein the characteristic of the polynucleotide is the identity of at least one nucleotide subunit of the analyte domain (claim 15), in the reply filed August 25, 2026 is acknowledged.
Claims 18-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 4, 5, 8-12, 14 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim.
The restriction requirement is still deemed proper and is therefore made FINAL.
Please Note: in the reply filed August 25, 2026, Applicant elected Species (D), claim 7, such that claim 9 is withdrawn from consideration because it depends from withdrawn claim 8. Additionally, for Species (A), Applicant elected claim 2, such that claim 10 is withdrawn from consideration because it depends from withdrawn claim 10.
The claims will be examined insofar as they read on the elected species.
Therefore, claims 1-3, 6, 7, 13, 15 and 16 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed October 12, 2023 is a CON of US Patent Application 14419217, filed February 2, 2015 (now US10858700), which is a 35 U.S.C. 371 national stage filing of International Application PCT/US2013/053476, filed on August 2, 2013, which claims the benefit of the US Provisional Patent Application 61679623, filed August 3, 2012.
Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application 61/679,623, filed August 3, 2012, fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. The specific method steps recited in independent claim 1 does not have support for: an analyte domain, an end domain with a net positive charge, a net charge that is less than the average charge density of the analyte domain, thereby providing the end domain with a charge that is opposite of the analyte domain, or a net charge that is less than the average charge density of the analyte domain, wherein the difference in the ion current from a threshold amount in the current pattern indicates a characteristic of the polynucleotide, and/or an opening or vestibule with a net positive charge. Therefore, the priority date for the presently claimed invention is August 2, 2013, the filing date of PCT/US2013/053476.
Applicants are invited to specifically indicate the location of the cited phrase pertinent to claim 1 of the instant application.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on October 12, 2023 and June 5, 2024 have been considered. Initialed copies of the IDSs accompany this Office Action.
Claim Objections/Rejections
Claim Objections
Claim 13 is objected to because of the following informalities: Claim 13 recites the terms “m V” and “V” where an abbreviation should be spelled out in the first encounter of the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112, 2nd paragraph
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 6, 7, 13, 15 and 16 are rejected under 35 U.S.C. 112, 2nd paragraph as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 is indefinite for the recitation of the term “the average charge density” such as recited in claim 1, line 9. There is insufficient antecedent basis for the term “the average charge density” in the claim.
Claim 3 is indefinite for the recitation of the term “charged amino acid” such as recited in claim 3, lines 1-2 because claim 3 depends from instant claim 1, wherein claim 1 does not recite a polynucleotide and/or a hybrid polynucleotide comprising amino acid residues. Moreover, the as-filed Specification does not recite that a polynucleotide in the nanopore comprises an amino acid, a peptide, an oligonucleotide, etc. and, thus, the metes and bounds of the claim cannot be determined.
Claim 7 is indefinite for the recitation of the term is “a homolog thereof” such as recited in claim 7, line 2 because it is unclear what protein nanopores are encompassed by being homologs of a-hemolysin or Mycobacterium smegmatis porin A, and whether term includes all proteins that form b-barrel pores, all pore-forming toxins produced by S. aureus, all pore-forming toxins of any bacterial species, all sequence homologs of Mycobacterium smegmatis porin A, all proteins that form octameric b-barrel pores, MspB, MspC, MspD, etc. and, thus, the metes and bounds of the claim cannot be determined.
Claim 16 is indefinite for the recitation of the term “the current” such as recited in claim 16, line 1. There is insufficient antecedent basis for the term “the current” in the claim because claim 1, line 5 recites the term “an ion current”. Moreover, claim 16 depends from instant claim 1, wherein claim 1 does not recite the presence of an analyte, a reference current, current blockades, measuring a difference, known current patterns, a known analyte, etc. and, thus, the metes and bounds of the claim cannot be determined.
Claim 16 is indefinite for the recitation of the term “one or more blockades” such as recited in claim 16, line 4. There is insufficient antecedent basis for the term “one or more blockades” in the claim because claim 16, line 2 recites the term “a blockade”.
Claims 2, 6, 13 and 15 are indefinite insofar as they ultimately depend from instant claim 1.
Claim Rejections - 35 USC § 112, 4th paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 16 are rejected under 35 U.S.C. 112, 4th paragraph as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 recites (in part): “wherein the first charged moiety is a charged amino acid or basic residue forming a cation” in lines 1-2 because the claim 3 depends from instant claim 1, wherein claim 1 does not recite a polynucleotide comprising amino acids, charged amino acid residues, peptides, oligonucleotides, etc. Thus, claim 3 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 16 recites (in part): “wherein a difference in the current from a reference current defines a blockade in the current pattern…using a known polynucleotide analyte” in lines 1-5 because the claim 16 depends from instant claim 1, wherein claim 1 does not recite the presence of an analyte, a reference current, current blockades, measuring a difference, known current patterns, a known analyte, etc. Thus, claim 16 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-3, 6, 7, 13, 15 and 16 are rejected under 35 U.S.C. 102(b) as being anticipated by Maglia et al. (hereinafter “Maglia”) (US Patent Application Publication No. 20110311965, published December 22, 2011).
Regarding claim 1, Maglia teaches enhancing translocation of a charged analyte through a transmembrane protein pore, wherein translocation is enhanced by increasing the net opposing charge of the barrel or channel and/or entrance of the pore (Abstract). Maglia teaches determining presence or absence of an analyte in a sample, comprising: (a) contacting the sample with a transmembrane protein pore of the invention under conditions that allow the analyte, if present, to translocate through and interact with the pore; and (b) measuring the current passing through the pore during the interaction and thereby determining the presence or absence of the analyte; and a method of sequencing a target nucleic acid sequence, comprising: (a) pushing or pulling the target sequence through a transmembrane protein pore of the invention so that a proportion of the nucleotides in the target sequence interact with the pore; and (b) measuring the current passing through the pore during each interaction and thereby determining the sequence of the target sequence (interpreted as applying an electric field; measuring ion current using a nanopore; and the difference in ion current indicates a characteristic of the polynucleotide, claim 1) (paragraphs [0015]-[0020]). Maglia teaches that a distinctive current flows through the pore whenever the analyte interacts with the pore, wherein this allows the analyte to be detected using stochastic sensing, such that the method can enhance the translocation of the analyte in any way including: (1) increases the frequency of translocation of the analyte through the pore, (2) decreases the threshold voltage for translocation of the analyte through the pore, (3) decreases the speed of translocation of the analyte through the pore, or (4) decreases the number of non-translocation interactions between the analyte and the pore (interpreted as a difference in ion current from a threshold amount, claim 1) (paragraphs [0055], lines 7-10 and [0056], lines 1-8). Maglia teaches that the apparatus comprises a chamber comprising an aqueous solution and a barrier that separates the chamber into two sections, wherein the barrier has an aperture in which the membrane containing the pore is formed, such that the analyte can be contacted with the pore by introducing the analyte into the chamber, wherein the method involves measuring the current passing through the pore during interaction with the analyte, such that the apparatus also comprises an electrical circuit capable of applying a potential and measuring an electrical signal across the membrane and pore (interpreted as a nanopore; a first conductive medium and a second conductive medium; applying an electric field; measuring an ion current; and an opening or vestibule, claim 1) (paragraphs [0151] and [0153]). Maglia teaches a polynucleotide sequence that encodes a transmembrane protein pore having an increased net opposing charge in its barrel or channel and/or entrance, wherein an increased net positive charge enhances translocation of a negatively charged analyte through the pore; and an increased negative charge enhances translocation of a positively charged analyte through the pore, such that the pore can be enhanced using any method described herein (interpreted as a polynucleotide comprising an analyte domain (sequence) and an end domain (nucleotide) comprising a first charged moiety with a net positive charge, claim 1) (paragraph [0127]). Maglia teaches that if the analyte is negatively charged and the method involves increasing the net positive charge of the barrel or channel and/or entrance of the pore, wherein the net positive charge can be increased by introducing one or more positively charged amino acids into the barrel or channel and/or entrance of the pore, including by addition or by substitution, wherein a positively charged amino acid is an amino acid with a net positive charge, which can be naturally-occurring or non-naturally-occurring, synthetic or it can be a modified amino acid that is specifically designed for use in the invention (interpreted as an end domain with a net positive charge; and opposite the analyte domain, claim 1) (paragraphs [0099]-[0100]). Maglia teaches that an analyte can be a polymer such as a nucleic acid sequence, or an analyte can be an individual nucleotide or a single nucleotide, wherein an individual nucleotide is one which is not bound to another polynucleotide by a nucleotide bond, such that the nucleotide bond involves one of the phosphate groups of a nucleotide being bound to the sugar group of another nucleotide, wherein nucleotides are negatively charged (paragraphs [0062], lines 1-3 and [0068]). Maglia teaches that by enhancing translocation of the analyte through the pore, the method of the invention provides an improved pore for stochastic sensing of the analyte, and it results in a more sensitive system that: (1) allows the detection of the analyte at both high and low concentrations; (2) allows the detection of the analyte even amongst impurities; (3) allows more rapid detection of the analyte; (4) reduces the background noise produced by non-translocation interactions; and (5) allows the detection of the analyte at a lower voltage, such that an enhanced translocation including an enhanced frequency of translocation, results in a reduced deadtime between reads of the consecutive nucleotides in the sequence, which allows nucleic acids to be sequenced more quickly (paragraph [0058]).
Regarding claim 2, Maglia teaches that the nucleic acid can be single-stranded or double-stranded including cDNA, RNA, or DNA (interpreting the polynucleotide to comprise DNA, RNA, etc., claim 2) (paragraph [0064]).
Regarding claim 3, Maglia teaches that naturally-occurring positively charged amino acids include, but are not limited to, histidine (H), lysine (K), and arginine (R), wherein any number and combination of H, K and/or R can be introduced into the barrel or channel and/or entrance of the pore (interpreted as a charged amino acid or basic residue forming a cation, claim 3) (paragraph [0101]).
Regarding claims 6 and 7, Maglia teaches that Figure 1 shows sections through an
a-hemolysin nanopore (interpreted as a protein nanopore; and an a-hemolysin nanopore, claims 6 and 7) (paragraph [0022], lines 1-3; and Figure 1). Maglia teaches that pores for use in accordance with the invention can be b-barrel pores or a-helix bundle pores, wherein b-barrel pores comprise a barrel or channel that is formed from b-sheets, such as a-hemolysin and leucocidins, and outer membrane proteins/porins of bacteria such as Mycobacterium smegmatis porin A (MspA), outer membrane porin F (OmpF), outer membrane porin G (OmpG), outer membrane phospholipase A, and Neisseria autotransporter lipoprotein (NalP) (interpreted as MspA, etc., claims 6 and 7) (paragraph [0075]).
Regarding claim 13, Maglia teaches that the voltage applied across the membrane and pore is from -400 mV to +400 mV (interpreted to encompass 40 mV to 1V, claim 13) (paragraph [0158], lines 5-7).
Regarding claim 15, Maglia teaches measuring the current passing through the pore during each interaction and thereby determining the sequence of the target sequence (interpreting the characteristic of the polynucleotide; and the identity of at least one nucleotide subunit, and the identity of the sequence, claim 15) (paragraph [0020]). Maglia teaches that differences between single nucleotide are measured by changes in conductance of the nanopore generated by the translocation of DNA (interpreted to be the identity of at least one nucleotide subunit, and the identity of the sequence, claim 15) (paragraph [0036], lines 11-13).
Regarding claim 16, Maglia teaches that a distinctive current flows through the pore whenever the analyte interacts with the pore, wherein this allows the analyte to be detected using stochastic sensing (interpreted as a difference in current for at least one subunit identifies at least one nucleotide, claim 16) (paragraph [0055], lines 7-10). Maglia teaches that results from carrying out the method on a test sample can be compared with those derived from a control experiment in order to identify a particular analyte in the sample, or to determine if a particular analyte is present in the sample (interpreted as comparing the analyte to a reference, or known analyte, claim 16) (paragraph [0150]). Maglia teaches that the analyte is present in any suitable sample, wherein the invention is typically carried out on a sample that is known to contain or suspected to contain the analyte, or it can be carried out on a sample that contains one or more analytes whose identity is unknown; alternatively, the invention can be carried out on a sample to confirm the identity of one or more analytes whose presence in the sample is known or expected (interpreted as comparing current patterns to a reference; and a known polynucleotide analyte, claim 16) (paragraph [0154]).
Maglia meets all the limitations of the claims and, therefore, anticipates the claimed invention.
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 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-3, 6, 7, 13, 15 and 16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Maglia et al. (hereinafter “Maglia”) (US Patent Application Publication No. 20110311965, published December 22, 2011) in view of Manrao et al. (hereinafter “Manrao”) (Nature Biotechnology, 2012, 30(4), 349-354).
The teachings of Maglia as applied to claims 1-3, 6, 7, 13, 15 and 16 are described supra.
Maglia does not specifically exemplify a biologically adapted solid-state nanopore (claim 6, in part).
Regarding claim 6 (in part), Manrao teaches resolving changes in current that correspond to a known DNA sequence by combining the high sensitivity of a mutated form of the protein pore Mycobacterium smegmatis porin A (MspA) with phi29 DNA polymerase (DNAP)4, which controls the of DNA translocation through the pore, such that as phi29 DNAP synthesizes DNA and functions like a motor to pull a single-stranded template through MspA, well-resolved and reproducible ionic current levels with median durations of ~28 ms and ionic current differences of up to 40 pA were observed; and using six different DNA sequences with readable regions 42-53 nucleotides long, current traces were recorded that map to the known DNA sequences with single-nucleotide resolution and DNA translocation control (Abstract). Manrao teaches that 24 positively charged residues in the vestibule and entrance, which enhanced the rate of entry of DNA into the pore were added, wherein this mutant, previously called M2-NNN MspA, is used in the present study and is here designated MspA, such that when DNA was held statically in the constriction of a mutant MspA by a conjugated NeutrAvidin molecule, different homopolymer strands resulted in conductance differences of as much as ~0.23 ns, nearly ten times more separation than that observed with the widely used α-hemolysin nanopore (~0.028 ns) (pg. 349, col 2, first partial paragraph, lines 7-14). Manrao teaches that phi29 DNAP is bound to a DNA template and a ‘blocking oligomer’ that prevents extension and excision primer annealed at the templates 3’ end, wherein the single-stranded end of this phi29 DNAP-DNA complex is drawn into the pore until the DNAP rests on the pore’s entrance, such that the previously engineered MspA nanopore was combined with the phi29 DNAP blocking oligomer technique to read well-resolved and distinguishable current levels as DNA is drawn through the pore (interpreting the engineered MspA as a biologically adapted solid-state nanopore, claim 6) (pg. 350, col 1, first partial paragraph, lines 1-3; and first full paragraph, lines 1-3). Manrao teaches that translocation events were recorded with current patterns consistent with force-activated unzipping of the blocking oligomer (interpreted as current patterns, claim 1) (pg. 350, col 1, last partial paragraph, lines 9-10). Manrao teaches that the patterns of current levels can be related to a known DNA sequence, and that automatic sequence extraction algorithms must be developed to sequence unknown DNA (interpreted as current patterns, claim 1) (pg. 350, col 1, last partial paragraph, lines 9-10).
It is prima facie obvious to combine prior art elements according to known methods to yield predictable results; the court held that, "…a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950)”. Therefore, in view of the benefits of reading DNA at single-nucleotide resolution as exemplified by Manrao, it would have been prima facie obvious for one of ordinary skill in the art at the time the invention was made to modify the method of enhancing the translocation of charged analytes through a nanopore by increasing the net opposing charge of the barrel, channel and/or entrance of a nanopore as disclosed by Maglia to include methods of controlling DNA translocation through a nanopore such as by combining an engineered MspA, a phi29 DNAP blocking oligomer, and/or adding positively charged residues in the vestibule as taught by Manrao with a reasonable expectation of success in enhancing translocation through a nanopore, such that the nanopore generates conductance differences sufficient for single nucleotide resolution of nucleic acid sequences; and/or in enhancing the translocation of nucleic acids through a nanopore, such that polynucleotide sequences can be identified by comparing any obtained patterns of current levels to the patterns of known nucleic acid sequences.
Thus, in view of the foregoing, the claimed invention, as a whole, would have been obvious to one of ordinary skill in the art at the time the invention was made. Therefore, the claims are properly
rejected under 35 USC §103(a) as obvious over the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 6, 7, 13, 15 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 1-17 of copending US Patent No. 10858700.
Claims 1-41 of copending US Patent No. 8673550.
US10858700 recites (in part): A method of analyzing a nucleic acid polymer comprising an end domain and an analyte domain, the method comprising: applying an electric field across a nanopore disposed between a first conductive liquid medium and a second conductive liquid medium…measuring an ion current to provide a current pattern as the analyte domain of the nucleic acid polymer passes through the nanopore, wherein the measured current pattern indicates a characteristic of the nucleic acid polymer analyte domain (claim 1).
US8673550 recites (in part): A method for detecting the presence of an analyte comprising: applying an electric field sufficient to translocate an analyte from a first conductive liquid medium to a second conductive liquid medium in liquid communication through a Msp having a vestibule…indicates the presence of the analyte in the first medium (claim 1).
Although the claims at issue are not identical, they are not patentably distinct from each other because: the instant claims, and the claims of U.S. Patent Nos. 10858700 and 8673550 teach a method of analyzing a polynucleotide using a nanopore comprising applying an electric field, measuring an ion current to provide a current pattern, an end domain comprising a first charged moiety with a net positive charge, wherein the current pattern indicates a characteristic of the polynucleotide.
Conclusion
Claims 1-3, 6, 7, 13, 15 and 16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M BUNKER whose telephone number is (313) 446-4833. The examiner can normally be reached on Monday-Friday (6am-2:30pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571) 272-2876. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/AMY M BUNKER/Primary Examiner, Art Unit 1684
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