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 .
Applicant’s amendment of claims 31, in the paper of 5/8/2026, is acknowledged. Applicants' argument filed on 5/8/2026, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. Claims 31-33, 57-64 are still at issue and are present for examination.
Election/Restriction
Applicant’s election of Group 3, claims 31, 32, 33 and 49, drawn to a method of controlling movement of a polynucleotide, in the paper of 1/17/2025, is acknowledged.
Claim Rejections - 35 USC § 112
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 31-33, 57-64 are 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 pre-AIA the applicant regards as the invention.
The rejection of claim 31 (claims 32-33, 57-64 dependent on) as indefinite in the recitation “an amino acid that increases interaction of the Dda helicase with the phosphate backbone of the single stranded polynucleotide;” is withdrawn based upon applicants amendment and arguments filed in the paper of 5/8/2026.
The rejection of claim 31 (claims 32-33, 57-64 dependent on) as indefinite in the recitation “a motif selected from: motif Ia, motif Ic, motif III, motif IV, motif V, and motif Vb” is withdrawn based upon applicants arguments filed in the paper of 12/19/2025 and the supporting Declaration under 37 CFR 1.132 by Rebecca Bowen.
The rejection of claim 31 (claims 32-33, 57-64 dependent on) was indefinite in the newly added recitation “wherein the positions are numbered by alignment of the amino acid sequence of the Dda helicase to the amino acid sequence set forth in SEQ ID NO: 8” is withdrawn based upon applicants amendment and arguments filed in the paper of 5/8/2026.
Claim 31 (claims 32-33, 57-64 dependent on) is indefinite in the recitation in part (ii) “wherein the at least one amino acid that interacts with one or more nucleotides in a single stranded polynucleotide” and the recitation in part (ii) “between the at least one amino acid of the Dda helicase” in that it is unclear as to the antecedent basis for each of the above references to “the at least one amino acid that interacts with one or more nucleotides in a single stranded polynucleotide” and “the at least one amino acid of the Dda helicase”. There is a lack of literal antecedent basis for each of the recitations.
With regard to the first recitation, “the at least one amino acid that interacts with one or more nucleotides in a single stranded polynucleotide” it is assumed that applicants intend that they mean “the at least one substitution of an amino acid that interacts with one or more nucleotides in a single stranded polynucleotide”.
With regard to the second recitation “the at least one amino acid of the Dda helicase” it is unclear and confusing as to the antecedent basis for the at least one amino acid of the Dda helicase.
Claim 31 (claims 32-33, 57-64 dependent on) is further indefinite in the recitation in part (ii) “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” in that it is unclear how “an amino acid (that is a substitution) can increase electrostatic interactions, hydrogen bonding, and/or cation-pi interactions between the at least one amino acid of the Dda helicase” (see also above rejection based upon lack of antecedent basis).
Appropriate amendment and/or comment is requested.
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(s) 31-33 and 57-64 are rejected under 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
Claim 31 (claims 32-33, 57-64 dependent on) remains rejected under this statute because the newly added recitation “in a motif selected from: motif Ia, motif Ic, motif IV, motif V, and motif Vb” is not supported by applicants specification at the time of filing and is thus considered new matter.
Applicants traverse this rejection on the basis that applicants amendment filed December 19, 2025 included arguments regarding possession of the recited motifs (pages 11-12, citing the Bowen Declaration and Exhibit A) and applicants submit that claim 31 has been amended to delete “motif III” from the list of motifs. Applicants further submit that one of ordinary skill would have recognized that the inventors were in possession of the claimed invention at the time of filing at least because the application as filed specifically identifies and contemplates substitution of amino acids located within motif Ia, motif Ic, motif IV, motif V and motif Vb of a Dda helicase as recited in claim 31, for use in the claimed method.
Applicants amendment of the claims and applicants complete argument is acknowledged and has been carefully considered, however, is not found persuasive for the reasons previously made of record and for those reasons repeated herein.
In response to applicants submission that one of ordinary skill would have recognized that the inventors were in possession of the claimed invention at the time of filing at least because the application as filed specifically identifies and contemplates substitution of amino acids located within motif Ia, motif Ic, motif IV, motif V and motif Vb of a Dda helicase as recited in claim 31, for use in the claimed method, this is not found persuasive on the basis that the substitution of amino acids located within a motif with a specified functional result does not support the substitution of additional amino acids within the same motif as having a similar functional result.
The previous rejection of claim 31 (claims 32-33, 57-64 dependent on) under this statute because the newly added recitation “an amino acid that increases interaction of the Dda helicase with the phosphate backbone of the single stranded polynucleotide” is not supported by applicants specification at the time of filing and is thus considered new matter is withdrawn based upon applicants amendment deleting this recitation.
Claim(s) 31-33 and 57-64 are rejected under 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
This rejection was stated in the previous office action as it applied to previous claims 31-33 and 57-64. In response applicants have amended the claims and argue the rejection as it applies to the newly amended claims.
Newly amended claim(s) 31-33 and 57-64 are directed to all possible methods 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 in the amino acid sequence set forth in SEQ ID NO: 8; and (ii) wherein the at 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 (see also above rejection under 35 U.S.C. 112(b) and 35 U.S.C. 112 (pre-AIA ), second paragraph).
Applicants Response
In response to the above previous rejection, applicants note that they have amended the claims and continue to traverse the rejection as it applies to the newly amended claims. Applicants further submit that the skilled artisan would have recognized that the inventors were in possession of the claimed invention at the time of filing at least because the application as filed specifically identifies and contemplates substitution of amino acids located within motif Ia, motif Ic, motif IV, motif V, and motif Vb of a Dda helicase as recited in amended claim 31, for use in the claimed method.
Applicants submit that the application as filed teaches that Dda helicases having certain modifications "have an improved ability to control movement of a polynucleotide through a pore", making them suitable for the claimed method. These modifications include, for example, substituting amino acids that interact with nucleotides of single-stranded polynucleotides for amino acids having larger R groups and/or amino acids that increase interactions with phosphate groups thereof (e.g., via increasing electrostatic interactions, hydrogen bonding, and/or cation-pi interactions), e.g., as described at pages 19-22 of the application as filed.
Applicants submit that the application as filed also identifies specific amino acid positions within Dda helicases as being particularly suited for such modifications, including amino acid positions within motif Ia, motif Ic, motif IV, motif V, and motif Vb. Applicants submit that the as explained previously, these motifs are well- characterized structures that are highly conserved across Dda helicases and recognized as having polynucleotide-binding functions (e.g., motif Ia, motif Ic, motif IV, motif V, and motif Vb). Auxiliary Table 2 of Exhibit A, filed on December 19, 2025 summarizes the amino acid positions of these art-recognized motifs, and is reproduced in applicants response at page 10 (applicants response of 5/8/2026):
Applicants submit that while the application as filed may not explicitly recite the names of the art-recognized polynucleotide-binding motifs of Dda helicases, at least a partial structure of such motifs is disclosed in the recitation of positions comprised therein, including: H64, corresponding to motif Ia; T80, H82 and S83, corresponding to motif Ic; F240, N242, and K243, corresponding to motif IV; H396, T394, and K397, corresponding to motif V; and Y415, corresponding to motif Vb. T Applicants submit that the application as filed also explicitly identifies these positions as "interact[ing] with the sugar and/or base of one or more nucleotides in ssDNA" and "interact[ing] with one or more phosphates in one more nucleotides in ssDNA" and as suitable for modifications discussed therein, e.g., for the claimed method. Thus, one of ordinary skill in the art would recognize that the Inventors had possession of Dda helicases comprising at least one substitution of an amino acid that interacts with one or more nucleotides in a single stranded polynucleotide, 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, as recited in claim 31.
Applicants further submit that the specification also describes the genus of methods using variant Dda helicases with the claimed substitutions encompassed by the amended claims. Applicants submit that the specification discloses 16 Dda helicase sequences (SEQ ID NOs: 8-23), detailed alignment tables showing corresponding positions across all homologues (Tables 2 and 3), specific amino acid positions that interact with nucleotides and phosphate groups, specific preferred substitutions for each position, and working examples demonstrating the claimed methods. Applicants submit that the Bowen Declaration filed on December 19, 2025 also establishes that the structure-function correlation of the recited polynucleotide-binding motifs is conserved across Dda helicases and that one of ordinary skill in the art would predict that substitutions at the recited positions would have similar effects across Dda helicases. Accordingly, one of ordinary skill in the art would also have recognized that the inventors had possession of the genus of methods encompassed by the instant claims at the time of filing.
Applicants amendment of the claims and applicants complete argument is acknowledged and has been carefully considered, however, is found non-persuasive for the reasons previously stated and for those reasons repeated herein.
In response to applicants submission that the skilled artisan would have recognized that the inventors were in possession of the claimed invention at the time of filing at least because the application as filed specifically identifies and contemplates substitution of amino acids located within motif Ia, motif Ic, motif IV, motif V, and motif Vb of a Dda helicase as recited in amended claim 31, this is not found persuasive for the reasons previously made of record and for those reasons repeated herein.
In response to applicants submission that the application as filed teaches that Dda helicases having certain modifications "have an improved ability to control movement of a polynucleotide through a pore", making them suitable for the claimed method, while this may be true that the application teaches that specified modifications result in improved ability to control movement of a polynucleotide through a pore, the application does not teach or support all of the modifications encompassed by applicants current claims (i.e. each amino acid located within motif Ia, motif Ic, motif IV, motif V, and motif Vb of a Dda helicase) have similar results.
While applicants describe modifications which include, substituting amino acids that interact with nucleotides of single-stranded polynucleotides for amino acids having larger R groups and/or amino acids that increase interactions with phosphate groups thereof (e.g., via increasing electrostatic interactions, hydrogen bonding, and/or cation-pi interactions), these do not help applicants description of those modifications outside the actual specified positions taught.
While applicants may identify specific amino acid positions within Dda helicases as being particularly suited for such modifications, including amino acid positions within motif Ia, motif Ic, motif IV, motif V, and motif Vb, applicants make no association of the specific amino acid positions with any domain or motif including motif Ia, motif Ic, motif IV, motif V, and motif Vb.
Applicants submission that while the application as filed may not explicitly recite the names of the art-recognized polynucleotide-binding motifs of Dda helicases, at least a partial structure of such motifs is disclosed in the recitation of positions comprised therein, including: H64, corresponding to motif Ia; T80, H82 and S83, corresponding to motif Ic; F240, N242, and K243, corresponding to motif IV; H396, T394, and K397, corresponding to motif V; and Y415, corresponding to motif Vb. T, is acknowledged, however, is not found persuasive for the same reasons as stated previously and above, as the reference to one or two amino acid positions within an asserted domain does not adequately the describe the entire asserted domain.
In response to applicants submission that the specification also describes the genus of methods using variant Dda helicases with the claimed substitutions encompassed by the amended claims and the specification discloses 16 Dda helicase sequences (SEQ ID NOs: 8-23), detailed alignment tables showing corresponding positions across all homologues (Tables 2 and 3), specific amino acid positions that interact with nucleotides and phosphate groups, specific preferred substitutions for each position, and working examples demonstrating the claimed methods is acknowledged, however, is not found persuasive for the same reasons as stated previously and above, as the reference to one or two amino acid positions within an asserted domain does not adequately the describe the entire asserted domain.
In response to applicants submission that the Bowen Declaration filed on December 19, 2025 also establishes that the structure-function correlation of the recited polynucleotide-binding motifs is conserved across Dda helicases and that one of ordinary skill in the art would predict that substitutions at the recited positions would have similar effects across Dda helicases is acknowledged, however, is not found persuasive for the same reasons as stated previously and above, as the reference to one or two amino acid positions within an asserted domain does not adequately the describe the entire asserted domain.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Claim Rejections - 35 USC § 102
The rejection of claim(s) 31-33 and 49 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Heron et al. (WO 2014/135838) is withdrawn based upon applicants amendment of the claims in the paper of 7/25/2025.
The rejection of claim(s) 31-33 and 49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jayasinghe et al (WO 2010/004265 published Jan. 14, 2010) is withdrawn based upon applicants amendment of the claims in the paper of 7/25/2025.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 31-33 and 57-64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of US 11,965,183. Although the claims at issue are not identical, they are not patentably distinct from each other claims 1-22 of US 11,965,183 are drawn to a method of characterizing 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 characterizing 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. anticipate and make obvious instant claims 31-33 and 57-64 drawn to a method of controlling the 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 the movement of a polynucleotide; thereby controlling the movement of the polynucleotide.
Applicants request for reconsideration of the above rejections based upon claim amendments presented herein is acknowledged, however, is not found persuasive in overcoming the rejection for the reasons stated above.
Claims 31-33 and 57-64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of US 10,724,018. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5 of US 10,724,018 are drawn to method of controlling the movement of a polynucleotide with respect to a transmembrane pore, comprising contacting the polynucleotide with a DNA-dependent ATPase (Dda) helicase modified to comprise a first cysteine residue and/or a first non-natural amino acid that has been introduced into (i) the tower domain, (ii) the pin domain, or (iii) the 1A (RecA-like motor) domain, wherein the first cysteine residue and/or the first non-natural amino acid is connected to a second cysteine residue and/or second non-natural amino acid that has been introduced into (i) the tower domain, (ii) the pin domain, or (iii) the 1A (RecA-like motor) domain and wherein the helicase retains its ability to control the movement of a polynucleotide with respect to the transmembrane pore, and thereby controlling the movement of the polynucleotide, in order to form a complex; and contacting a transmembrane pore with the complex anticipate and make obvious instant claims 31-33 and 57-64 drawn to a method of controlling the 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
Applicants request for reconsideration of the above rejections based upon claim amendments presented herein is acknowledged, however, is not found persuasive in overcoming the rejection for the reasons stated above.
Claims 31-33 and 57-64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US 10,443,097. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-10 of US 10,443,097 are drawn to 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 anticipate and make obvious instant claims 31-33 and 57-64 drawn to a method of use or a method of controlling the 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 acid that improves interaction of the Dda helicase with the phosphate backbone of the single stranded polynucleotide; and (b)
Applicants request for reconsideration of the above rejections based upon claim amendments presented herein is acknowledged, however, is not found persuasive in overcoming the rejection for the reasons stated above.
Claims 31-33 and 57-64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of US 10,724,087. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-13 of US 10,724,087 are drawn to method of characterizing a target polynucleotide, comprising: (a) contacting the target polynucleotide with a transmembrane pore, wherein a first helicase is bound to the target polynucleotide such that the first helicase controls the movement of the target polynucleotide through the pore; (b) further contacting the target polynucleotide with a second helicase as the first helicase controls the movement of the target polynucleotide through the transmembrane pore, wherein the second helicase binds to an internal polynucleotide of the target polynucleotide at a location on the polynucleotide different than where the first helicase is bound without concurrent binding to a terminal nucleotide of the target polynucleotide, and wherein the second helicase controls movement of the target polynucleotide through the pore after the first helicase disengages from the target polynucleotide; and (c) measuring one or more characteristics of the target polynucleotide during one or more interactions as the target polynucleotide moves through the transmembrane pore, wherein the one or more interactions are measured along a length of the target polynucleotide that comprises at least 500 nucleotides and exceeds processivity of the first helicase, thereby characterizing the target polynucleotide anticipate and make obvious instant claims 31-33 and 57-64 drawn to a method of controlling the 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 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 are numbered by alignment of the amino acid sequence of the Dda helicase to the amino acid sequence set forth in SEQ ID NO: 8; wherein the helicase is configured to control the movement of a polynucleotide; thereby controlling the movement of the polynucleotide.
Applicants request for reconsideration of the above rejections based upon claim amendments presented herein is acknowledged, however, is not found persuasive in overcoming the rejection for the reasons stated above.
Claims 31-33 and 57-64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of US 10,221,450. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-12 of US 10,221,450 are drawn to method comprising: (a) providing a complex comprising one or more helicases bound, in an active mode, to a polynucleotide, wherein the polynucleotide comprises one or more spacers that are configured such that movement of the one or more helicases relative to the polynucleotide is stalled: (b) contacting a transmembrane pore, which is present in a membrane, with the complex, wherein the transmembrane pore comprises an opening that permits passage of the polynucleotide, but not the one or more helicases, across the membrane; and (c) applying a potential difference across the membrane such that the polynucleotide moves through the transmembrane pore and such that the one or more helicases pass across the one or more spacers of the polynucleotide anticipate and make obvious instant claims 31-33 and 57-64 drawn to a method of controlling the 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
Applicants request for reconsideration of the above rejections based upon claim amendments presented herein is acknowledged, however, is not found persuasive in overcoming the rejection for the reasons stated above.
The office has made a reasonable attempt at identifying all issued patents and applications subject to a double patenting rejection. Applicants are asked to identify any additional issued patents or applications that the office should be aware of for consideration of double patenting.
Remarks
No claim is allowed.
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 RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached on 6-3 EST Mon-Fri.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
6/24/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652