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 .
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.
Status of Claims
Claims 1-6, 8-9, 11-16, 22-24, 28 and 41-42 are pending. Claims 1-6, 8-9, 11-16, 22-24, and 41-42 are withdrawn. Claim 28 is under examination.
Election/Restrictions
Applicant’s election without traverse of Group II (claim 28) and the elected species of SEQ ID NOs: 2 and 24 in the reply filed on 05/13/2026 is acknowledged.
Claims 1-6, 8-9, 11-16, 22-24, and 41-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse.
Information Disclosure Statement
The information disclosure statement (IDS) documents submitted on 05/13/2026 and 11/07/2023 have been considered by the examiner.
Claim Objections
Claim 28 is objected to because of the following informalities: The claim interchangeably reciting “target polynucleotide” and “polynucleotide”. For consistency, it should only recite – target polynucleotide –. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 28 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that, for a claimed genus, the written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
The claim is directed to a method of characterizing a target polynucleotide comprising providing a transmembrane pore and a polynucleotide binding protein, contacting the transmembrane pore and polynucleotide binding protein with the target polynucleotide such that the protein controls the movement of the polynucleotide with respect to the transmembrane pore and
The claim as a whole cover a genus of polynucleotide binding proteins. Explicit in the claims is that such proteins control the movement of the target polynucleotide with respect to the transmembrane pore which invokes possessions of certain functional characteristics; namely, the ability to control the movement of the target polynucleotide.
Level of skill and knowledge in the art:
Carson et al. teach the parameters that one needs to control and interpret for nanopore-based DNA sequencing, it is not surprising that nanopores are among the most difficult techniques to interpret (see pg. 1, left col., para. 2). Carson teaches uncontrollable forward-reverse motion and enzyme malfunction. Married to all of the above challenges in DNA motion control is yet another layer of complication (see pg. 1, right col. para. 1). Carson also teaches that controlling DNA motion through nanopore, and readout of its sequence, are independently grand challenges that require further development (see pg. 11, left col., last para.). (Carson et al., “Challenges in DNA motion control and sequence readout using nanopore devices”, Nanotechnology, vol. 26, 2015, 074004, pages 1-14).
The disclosure:
The specification discloses a Dda helicase wherein the helicase-T4 Dda – E94C/Cl09A/C136A/A360C (SEQ ID NO: 24 with mutations E94C/Cl09A/C136A/A360C) was used to control the movement of DNA construct X or Y through a number of different MspA nanopores. All of the nanopores tested exhibited changes in current as the DNA translocated through the nanopore. The mutant nanopores tested exhibited either more consistent movement of the target polynucleotide or reduced noise associated with the movement of the target polynucleotide as it translocated through the nanopore or both (see pg. 93, lines 5-12, as filed dated 06/27/2023). The specification discloses using either T4 Dda – E94C/Cl09A/C136A/A360C or T4 Dda – E94C/Cl09A/C136A/K199L/A360C was added to the nanopore system (see pg. 102, lines 1-5, as filed). A number of different nanopores/enzyme combinations were investigated in order to determine the affect of mutations to regions of the transmembrane pore and enzyme which were thought to interact with each other. These mutation positions were identified in the molecular modeling experiment described in Example 1 (see pg. 102, lines 18-22, as filed). Table 12 shows the different pore and enzyme combinations tested (see pg. 103, lines 33-34, as filed). Meanwhile, as disclosed, Table 12 (see pg. 103) only discloses T4 Dda – E94C/Cl09A/C136A/A360C and T4 Dda – E94C/Cl09A/C136A/K199L/A360C as the enzyme (i.e., polynucleotide binding protein) to control the movement of the polynucleotide with respect to the transmembrane pore.
In other words, the specification discloses specific structures to control the movement of the polynucleotide with respect to the transmembrane pore. The instant application has not provided a sufficient description showing possession of the necessary functional characteristics that correlates between the proteins and the target polynucleotide with respect to the transmembrane pore. Because the disclosure lacks a representative number of species to control movements of polynucleotide for reliable measurements in characterizing the target polynucleotide, the skilled artisan would not be able to conclude that by using a genus of polynucleotide binding proteins would control the movement of the polynucleotide with respect to the transmembrane pore.
Given the claimed broadly class of polynucleotide binding proteins and in the absence of sufficient disclosure of relevant processes for identification, the patentee must establish “a reasonable structure-function correlation” either within the specification or by reference to the knowledge of one skilled in the art with functional claims AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014) and the specification at best describes plan for making fusion proteins encompassed by the “limitations above” and then identifying those that satisfy claim limitations, but mere “wish or plan” for obtaining claimed invention is not sufficient. Centocor Ortho Biotech Inc. v. Abbott Laboratories, 97 USPQ2d 1870 (Fed. Cir. 2011).
In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 43 USPQ2d 1398 (Fed Cir. 1997)). Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.).
The instant disclosure, including the claims fail to disclose a representative number of species falling with the scope of the claimed genuses or structural common to the members of the genuses so the one of skill in the art can visualize or recognize the member of the genus for binding.
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
Because of this lack of guidance, the extended experimentation that would be required to determine which substitutions would be acceptable to retain DNA-dependent ATPase (Dda) helicase and polynucleotide movement activity and the fact that the relationship between the sequence of a peptide and its tertiary structure (i.e. its activity) are not well understood and are not predictable (e.g., see Ngo et al. in The Protein Folding Problem and Tertiary Structure Prediction, 1994, Merz et al. (ed.), Birkhauser, Boston, MA, pp. 433 and 492-495), it would require undue experimentation for one skilled in the art to arrive at those particular DNA-dependent ATPase (Dda) helicases of the claimed genus.
In conclusion, there is nothing in the application as filed that discloses a representative of species. There is no disclosure of any particular structure to function/activity relationship in the disclosed species. The specification also fails to describe additional representative species of these mutant DNA-dependent ATPase (Dda) helicases by any identifying structural characteristics or properties, for which no predictability of structure is apparent. Given this lack of additional representative species as encompassed by the claims, Applicants have failed to sufficiently describe the claimed invention, in such full, clear, concise, and exact terms that a skilled artisan would recognize Applicants were in possession of the claimed invention. The full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first 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.
Claim 28 is rejected 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 which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 28 recites the protein controls the movement of the polynucleotide with respect to the transmembrane pore is unclear to the structure-function relationship of what is considered being controlled by the protein with respect to the transmembrane pore. Does the term “control” encompass conjugating to a moving protein? Thus, it is unclear to the metes and bounds of what is being controlled by a protein because there is a lack in structure of the protein as claimed (see above in written description). Also, the claim recites “with respect to the transmembrane pore” is unclear if whether the polynucleotide binding protein and the target polynucleotide are processing through the transmembrane pore or the movement is outside of said pore. Thus, it is unclear to what is being measured to characterize the target polynucleotide.
Additionally, the phrase “the protein controls” is unclear to whether the protein is referring to the transmembrane pore or the polynucleotide binding protein. Note that the transmembrane pore is formed by at least a protein.
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.
Claim 28 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clarke et al. (WO2012/107778A2, published 08/16/2012, IDS submitted 11/07/2023, page 8).
Clarke teaches mutants forms of Msp and relates to nucleic acid characterization using Msp (see abstract). Fig. 18 shows an example even trace for the controlled translocation of DNA, mediated by a helicase, through the MS-(B1-B1)4 mutant pore which was produced by oligomerisation of the dimer (also see pg. 6, lines 17-22). Clarke teaches the mutant monomer is chemically modified with a molecular adaptor that facilitates the interaction between a pore comprising the monomer and a target nucleotide or target nucleic acid sequence and the adaptor has an effect on the physical or chemical properties of the pore that improves its interaction with the nucleotide or nucleic acid sequence (see pg. 24, lines 11-20), which would read on a method of characterising a target polynucleotide, comprising: a) providing a transmembrane pore and a polynucleotide binding protein in which a part of the transmembrane pore which interacts with the polynucleotide binding protein and/or a part of the polynucleotide binding protein which interacts with the transmembrane pore has been modified; b) contacting the transmembrane pore and polynucleotide binding protein provided in (a) with the target polynucleotide such that the protein controls the movement of the polynucleotide with respect to the transmembrane pore; and c) taking one or more measurements as the polynucleotide moves with respect to the transmembrane pore, wherein the measurements are indicative of one or more characteristics of the polynucleotide, and thereby characterising the target polynucleotide.
Claim 28 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gundlach et al. (US2012/0055792A1, 03/08/2012, IDS submitted 05/13/2026).
Gundlach teaches mycobacterium smegmatis porin nanopores, systems that comprise these nanopores and such nanopores may be MspA (abstract and Fig. 1). Fig. 1 shows providing a transmembrane pore wherein the transmembrane pore has been modified (also see abstract, mutant MspA). Fig. 9 shows a neutravidin protein conjugated to ssDNA. Gundlach teaches contacting the transmembrane pore with the target polynucleotide and taking one or more measurements as the polynucleotide moves with respect to the transmembrane pore, wherein the measurements are indicative of one or more characteristics of the polynucleotide and thereby characterizing the target polynucleotide (see Figs. 5A-5C). Gundlach teaches the Msp porin may further comprise a molecular motor and the molecular motor may be capable of moving an analyte into or through a tunnel with a translocation velocity (see para. [0051]). Gundlach teaches the molecular motors may be helicases (see para. [0184]). Note that based on (1) the instant disclosure (see above) that only two variants of SEQ ID NO: 24 control the movement of the polynucleotide through the MspA nanopore (i.e., SEQ ID NO: 24 has not been disclosed in the Examples for controlling target polynucleotide), (2) the references recognize that the relationships between the sequence of a peptide and its tertiary structure (i.e., its activity) are not predictable, and (3) the lack in clarity of the structure of the protein to control the movement of the target polynucleotide (see above), it is not possible to conclude that SEQ ID NO: 24 in a tertiary structure would control the movement of a polynucleotide as claimed. Meanwhile, SEQ ID NO: 1 of Gundlach would read on the elected species of SEQ ID NO: 2:
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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.
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 23 of U.S. Patent No. 9751915B2 (‘915) (IDS submitted 11/07/2023, page 1). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 23 of Patent ‘915 recites a method of characterising a target nucleic acid sequence, comprising: (a) contacting the target nucleic acid sequence with a pore according to claim 14, 16 or 20 and a nucleic acid binding protein so that the nucleic acid binding protein controls the movement of the target nucleic acid sequence through the pore, wherein the nucleic acid binding protein is selected from the group consisting of nucleases, polymerases, topoisomerases, ligases, helicases, and single strand binding proteins (SSB); and (b) measuring, upon application of a potential across the pore, a current passing through the pore as the target nucleic acid sequence moves through the pore, wherein the current flow through the pore is distinctive for nucleotides of the target nucleic acid and thereby characterising the target nucleic acid sequence based on the current measurements.
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10443097B2 (‘097). Although the claims at issue are not identical, they are not patentably distinct from each other because Patent ‘097 recites a method of characterizing a target polynucleotide, comprising: a) providing a transmembrane pore and a polynucleotide binding protein in which a part of the transmembrane pore which interacts with the polynucleotide binding protein and/or a part of the polynucleotide binding protein which interacts with the transmembrane pore has been modified, wherein the modification comprises an amino acid substitution, insertion, or deletion relative to an unmodified transmembrane pore or polynucleotide binding protein; b) contacting the transmembrane pore and polynucleotide binding protein provided in (a) with the target polynucleotide such that the polynucleotide binding protein controls the movement of the polynucleotide with respect to the transmembrane pore; and c) taking one or more electrical or optical measurements as the polynucleotide moves with respect to the transmembrane pore..
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10844432B2 (‘432). Although the claims at issue are not identical, they are not patentably distinct from each other because Patent ‘432 recites a method of characterizing a target polynucleotide, comprising: (a) providing a transmembrane pore and a polynucleotide binding protein in which a part of the polynucleotide binding protein which interacts with the transmembrane pore has been modified, wherein the modification comprises an amino acid substitution, insertion, or deletion relative to an unmodified polynucleotide binding protein; (b) contacting the transmembrane pore and polynucleotide binding protein provided in (a) with the target polynucleotide such that the polynucleotide binding protein controls the movement of the polynucleotide with respect to the transmembrane pore; and (c) taking one or more electrical or optical measurements as the polynucleotide moves with respect to the transmembrane pore.
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11739377 B2 (‘377). Although the claims at issue are not identical, they are not patentably distinct from each other because Patent ‘377 recites a method of characterizing a target polynucleotide, comprising: a) providing a transmembrane MspA pore and a polynucleotide binding protein in which a part of the transmembrane MspA pore which interacts with the polynucleotide binding protein and a part of the polynucleotide binding protein which interacts with the transmembrane MspA pore has been modified, wherein the modification of the transmembrane MspA pore comprises an amino acid substitution, insertion, or deletion relative to an unmodified transmembrane MspA pore, and wherein the modification of the polynucleotide binding protein comprises an amino acid substitution, insertion, or deletion relative to an unmodified polynucleotide binding protein; b) contacting the transmembrane MspA pore and polynucleotide binding protein provided in (a) with the target polynucleotide such that the polynucleotide binding protein controls the movement of the target polynucleotide with respect to the transmembrane MspA pore; and c) taking one or more electrical or optical measurements as the target polynucleotide moves with respect to the transmembrane MspA pore.
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11965183B2 (‘183). Although the claims at issue are not identical, they are not patentably distinct from each other because Patent ‘183 recites a method of characterising a target polynucleotide, comprising: (a) contacting the target polynucleotide with a transmembrane pore and a helicase such that the helicase controls the movement of the target polynucleotide through the pore; and (b) taking one or more electrical measurements as the polynucleotide moves with respect to the pore wherein the measurements are indicative of one or more characteristics of the target polynucleotide and thereby characterising the target polynucleotide, wherein the helicase is a DNA-dependent ATPase (Dda) helicase in which: (i) the Dda helicase comprises a sequence that is at least 70% identical to the sequence set forth in SEQ ID NO: 8 and is recombinantly substituted in at least one residue corresponding to at least one of the following amino acid positions in SEQ ID NO: 8 which interacts with one or more nucleotides in single stranded DNA (ssDNA): H82, N88, P89, F98, D121, V150, P152, F240, F276, S287, H396 and/or Y415; and (ii) the part of the Dda helicase which interacts with the transmembrane pore comprises one or more modifications at one or more residues corresponding to a position in SEQ ID NO: 8 selected from the group consisting of: 3, 4, 5, 176, 177, 179, 180, 185, 193, 194, 195, 198, 199, 200, 202, 203, 204, 207, 208, 209, 210, 211, 212, 213, 216, 221, 224, 255, 318, 347, 405, 415, 434, 437, and 438. The helicase would read on the claimed polynucleotide binding protein.
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 45-46 of U.S. Patent No. 10266885 (‘885). Although the claims at issue are not identical, they are not patentably distinct from each other because Patent ‘885 recites a method for the characterization of a target polynucleotide, wherein said characterization is selected from: (i) the length of the polynucleotide, (ii) the identity of the polynucleotide, (iii) the sequence of the polynucleotide, (iv) the secondary structure of the polynucleotide, and (v) whether or not the polynucleotide is modified; said method comprising: a) contacting the polynucleotide with a pore according to claim 27 or 29, a polymerase and labelled nucleotides such that phosphate labelled species are sequentially added to the target polynucleotide by the polymerase, wherein the phosphate species contain a label specific for each nucleotide; and b) detecting the phosphate labelled species using the pore and thereby characterizing the polynucleotide. The recited polymerase would read on the polynucleotide binding protein.
Claim 28 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-33 and 57-64 of copending Application No. 18/596176 (‘176) (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 31 of the copending Application recites a method of controlling movement of a polynucleotide, comprising: contacting the polynucleotide with a DNA-dependent ATPase (Dda) helicase comprising:(a) at least one substitution of an amino acid that interacts with one or more nucleotides in a single stranded polynucleotide,(i) wherein the at least one substituted amino acid is: in a motif selected from: motif Ia, motif Ic, motif IV, motif V, and motif Vb; and/or at any one of positions 88, 89, 98, 121, 150, 152, 276, and 287;wherein the positions correspond to positions inat least one amino acid that interacts with one or more nucleotides in a single stranded polynucleotide is substituted with: an amino acid in a larger R group, and/or an amino acid that increases electrostatic interactions, hydrogen bonding, and/or cation-pi interactions between the at least one amino acid of the Dda helicase and one or more phosphate groups of the single stranded polynucleotide; and (b) one or more modifications at one or more positions selected from: 1-6, 51, 176- 181, 185, 189, 191, 193-204, 207-213, 216, 219-221, 223, 224, 226-229, 247, 254-261, 298, 300, 304, 308, 318, 319, 321, 337, 347, 350, 351, 405, 415, 422, 434, 437, and 438, wherein the positions correspond to positions in the amino acid sequence set forth in SEQ ID NO: 8; and (c) controlling the movement of the polynucleotide using the helicase. Claim 32 recites wherein the method is for controlling the movement of a polynucleotide through a transmembrane pore. Claim 33 recites characterising the polynucleotide, the characterising comprising: taking one or more measurements as the polynucleotide moves with respect to the transmembrane pore, wherein the one or more measurements are indicative of one or more characteristics of the polynucleotide; thereby characterising the polynucleotide. Thus, it would have been obvious to have used the recited claims of the copending Application to produce the method of the instant claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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