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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election of claims reciting complexes that is original claims set forth in group 1 in the reply filed on 12/17/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-27 have been cancelled.
Claims 28-57 are pending
Claims 46-57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 28-45, drawn to a complex comprising an anti-transferrin receptor (TfR) antibody covalently linked to an oligonucleotide that target Double-Homeobox 4 (DUX4) RNA, are examined on merits.
In this Office action transferrin receptor and TfR are interchangeable.
Information Disclosure Statement
The information disclosure statement (s) (IDS) submitted on 4/21/2023 and 12/17/2025 are/is considered by the examiner and initialed copies/copy of the PTO-1449 are/is enclosed.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
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 (MPEP 9th Ed, Feb 2023).
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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).
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.
Over Patents:
1. Claims 28-45 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over:
claims 1-24 of U.S. Patent No. 11,638,761 (original application 17/811380), and
claims 1-24 of U.S. Patent No. 11,969,475 (original application 18/495086), in view of Subramanian et al (WO2020/028864, published Feb 2020) or its national stage US Patent No. 11,111,309 (effective filing at Aug 2, 2018, used for this rejection) as evidenced by sequence alignment.
Although the conflicting claims are not identical, they are not patentably distinct from each other because all sets of claims are drawn to a complex or a composition comprising a complex comprising the same anti-transferrin R antibody with the same VH and VL linked to an oligonucleotide.
Both reference patents are from the same family as the instant application.
The instant claims are drawn to:
A complex comprising an anti-transferrin receptor (TfR) antibody covalently linked to an oligonucleotide, wherein the antibody comprises a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 76 and a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 75, and wherein the oligonucleotide targets a Double Homeobox 4 (DUX4) RNA,
wherein the VH of the antibody comprises an N- terminal pyroglutamate,
wherein the oligonucleotide comprises a region of complementarity to the 3' UTR of a DUX4 sequence as set forth in SEQ ID NO: 158, wherein the region of complementarity is 12-25 nucleotides in length.
A composition comprising a complex comprising an anti-transferrin receptor (TfR) antibody covalently linked to an oligonucleotide, wherein the antibody comprises a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 76 and a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 75, and wherein the oligonucleotide targets a Double Homeobox 4 (DUX4) RNA,
…………..
The claims of U.S. Patent No. 11,638,761 are drawn to
A composition comprising complexes comprising an anti-transferrin receptor antibody covalently linked to at least one oligonucleotide, wherein the antibody is a Fab and comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 101 and a light chain comprising the amino acid sequence of SEQ ID NO: 90, and wherein each anti-TfR antibody of the complexes is on average covalently linked to 1 to 3 oligonucleotides, and wherein the oligonucleotide targets a DUX4 RNA,
wherein the heavy chain of the antibody comprises an N-terminal pyroglutamate,
wherein the oligonucleotide is 15-35, 20-30 nucleotides in length and complementary to sequence of SEQ ID NO: 158.
…..
A method of reducing DUX4 expression in muscle cells of a subject, the method comprising administering to the subject the composition of claim 1.
The claims of U.S. Patent No. 11,969,475 are drawn to
A complex comprising an anti-transferrin receptor (TfR) antibody covalently linked to at least one oligonucleotide, wherein the antibody comprises: (i) a heavy chain comprising a heavy chain variable region (VH) and a human IgG CH1 domain and lacking a human IgG CH2 domain and CH3 domain, wherein the heavy chain comprises the amino acid sequence of SEQ ID NO: 101, and (ii) a light chain comprising a light chain variable region (VL) and a human kappa light chain constant region, wherein the light chain comprises the amino acid sequence of SEQ ID NO: 90; wherein each oligonucleotide is covalently linked to a lysine residue of the anti-TfR antibody, and wherein the oligonucleotide targets a DUX4 RNA,
wherein the heavy chain of the antibody comprises an N-terminal pyroglutamate.
wherein the oligonucleotide is single stranded, double stranded or d an siRNA….
A method of delivering an oligonucleotide to a subject, comprising administering to the subject the complex of claim 1, wherein the subject is human having FSHD.
All sets of the claims comprise the anti-transferrin receptor (TfR) antibody comprising the same VH and VL domains linked to oligonucleotide targeting Double Homeobox 4 (DUX4). The first difference is the anti-TfR antibody in the two reference patents ‘761 and ‘475 comprising the heavy and light chains while the antibody in instant application is VH and VL domains within the heavy and light chains of the antibody as evidenced by the sequence alignments below. Thus, the claims in reference patents have defined Fc domain of the antibody which have narrower scope.
QY=SEQ ID NO: 75 (VL):
US-17-811-380-90
Patent No. 11638761
APPLICANT: Dyne Therapeutics, Inc. (en)
TITLE OF INVENTION: MUSCLE TARGETING COMPLEXES AND USES THEREOF FOR TREATING FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY (en)
CURRENT APPLICATION NUMBER: US/17/811,380
CURRENT FILING DATE: 2022-07-08
NUMBER OF SEQ ID NOS: 158
SEQ ID NO 90
US-18-495-086-90
Patent No. 11969475
APPLICANT: Dyne Therapeutics, Inc. (en)
TITLE OF INVENTION: MUSCLE TARGETING COMPLEXES AND USES THEREOF FOR TREATING FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY (en)
FILE REFERENCE: D0824.70069US05
CURRENT APPLICATION NUMBER: US/18/495,086
CURRENT FILING DATE: 2023-10-26
NUMBER OF SEQ ID NOS: 158
SEQ ID NO 90
ALIGNMENT:
Query Match 100.0%; Score 563; Length 214;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSLSASVGDRVTITCRASQDISNFLNWYQQKPGQPVKLLIYYTSRLHSGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSLSASVGDRVTITCRASQDISNFLNWYQQKPGQPVKLLIYYTSRLHSGVPS 60
Qy 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQQGHTLPYTFGQGTKLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQQGHTLPYTFGQGTKLEIK 107
QY=SEQ ID NO: 76 (VH)
US-17-811-380-101
Patent No. 11638761
GENERAL INFORMATION
APPLICANT: Dyne Therapeutics, Inc. (en)
TITLE OF INVENTION: MUSCLE TARGETING COMPLEXES AND USES THEREOF FOR TREATING FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY (en)
FILE REFERENCE: D0824.70069US01
CURRENT APPLICATION NUMBER: US/17/811,380
CURRENT FILING DATE: 2022-07-08
NUMBER OF SEQ ID NOS: 158
SEQ ID NO 101
US-18-495-086-101
Patent No. 11969475
GENERAL INFORMATION
APPLICANT: Dyne Therapeutics, Inc. (en)
TITLE OF INVENTION: MUSCLE TARGETING COMPLEXES AND USES THEREOF FOR TREATING FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY (en)
FILE REFERENCE: D0824.70069US05
CURRENT APPLICATION NUMBER: US/18/495,086
CURRENT FILING DATE: 2023-10-26
ALIGNMENT:
Query Match 100.0%; Score 640; Length 227;
Best Local Similarity 100.0%;
Matches 119; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLQESGPGLVKPSQTLSLTCTVTGYSITSGYYWNWIRQPPGKGLEWIGYITFDGANNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLQESGPGLVKPSQTLSLTCTVTGYSITSGYYWNWIRQPPGKGLEWIGYITFDGANNY 60
Qy 61 NPSLKNRVSISRDTSKNQFSLKLSSVTAEDTATYYCTRSSYDYDVLDYWGQGTTVTVSS 119
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NPSLKNRVSISRDTSKNQFSLKLSSVTAEDTATYYCTRSSYDYDVLDYWGQGTTVTVSS 119
The method of using the product claimed in the reference patents would anticipate the product claims of present invention.
The claims of reference patents ‘761 and ‘475 do not recite that the oligonucleotide complementary to 3' UTR of a DUX4 sequence of SEQ ID NO: 158 as recited in the instant claim 32.
Subramanian et al in US Patent No.11,111,309 teach a 25 oligonucleotide as single strand nucleotide that complementary to the 3' UTR of RNA of DUX4 as evidenced by sequence alignment. Subramanian et al also teach disease FaciosScapulo Humeral Muscular Dystrophy (FSHD) is due the abnormal function of DUX4 and teach TfR antibody complex to deliver the oligonucleotide and methods of inhibiting expression and activity of DUX4 with oligonucleotide for treating such disease (table 1 and page 15-16 and examples).
US-17-205-123B-45/c
Patent No. 11111309
GENERAL INFORMATION
APPLICANT: Dyne Therapeutics, Inc.
TITLE OF INVENTION: MUSCLE TARGETING COMPLEXES AND USES THEREOF FOR TREATING
TITLE OF INVENTION: FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY
CURRENT FILING DATE: 2021-03-18
PRIOR FILING DATE: 2021-02-01
PRIOR APPLICATION NUMBER: PCT/US2019/044990
PRIOR FILING DATE: 2019-08-02
PRIOR APPLICATION NUMBER: US 62/713,933
PRIOR FILING DATE: 2018-08-02
Query Match 1.5%; Score 25; Length 25;
Best Local Similarity 100.0%;
Matches 25; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1666 AGTTCAGAGATATATTAAAATGCCC 1690
|||||||||||||||||||||||||
Db 25 AGTTCAGAGATATATTAAAATGCCC 1
US-17-205-123B-46
Filing date in PALM: 2021-03-18
Sequence 46, US/17205123B
Patent No. 11111309
Query Match 1.5%; Score 25; Length 25;
Best Local Similarity 100.0%;
Matches 25; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1666 AGTTCAGAGATATATTAAAATGCCC 1690
|||||||||||||||||||||||||
Db 1 AGTTCAGAGATATATTAAAATGCCC 25
In order to obtain a composition for treating a FSHD, one skilled in the art would be motivated with reasonable expectation of success to apply the teachings including the oligonucleotide to 3’UTR of Subramanian et al to arrive at current invention, a complex comprising TfR antibody linked to the oligonucleotide, without unexpected result.
2. Claims 28-45 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over Claims 1-22 of U.S. Patent No. 11,759,525 (original application 18/063797) in view of Subramanian et al (WO 2020/028864, published Feb 2020) or its national stage US Patent No. 11,111,309 (effective filing at Aug 2, 2018, used for this rejection) as evidenced by sequence alignment.
Although the conflicting claims are not identical, they are not patentably distinct from each other because all sets of claims are drawn to a complex or a composition comprising a complex comprising the same anti-transferrin R antibody with the same VH and VL linked to an oligonucleotide.
The instant claims are drawn to:
A complex comprising an anti-transferrin receptor (TfR) antibody covalently linked to an oligonucleotide, wherein the antibody comprises a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 76 and a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 75, and wherein the oligonucleotide targets a Double Homeobox 4 (DUX4) RNA,
wherein the VH of the antibody comprises an N- terminal pyroglutamate,
wherein the oligonucleotide comprises a region of complementarity to the 3' UTR of a DUX4 sequence as set forth in SEQ ID NO: 158, wherein the region of complementarity is 12-25 nucleotides in length.
The claims of U.S. Patent No. 11,759,525 are drawn to
A composition comprising complexes comprising an anti-transferrin receptor (TfR) antibody covalently linked to at least one siRNA, wherein the antibody is a Fab and comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 101 and a light chain comprising the amino acid sequence of SEQ ID NO: 90, and wherein each anti-TfR antibody of the complexes is on average covalently linked to 1 to 3 siRNAs, and wherein the siRNA targets a DUX4 RNA,
wherein the heavy chain of the antibody comprises an N-terminal pyroglutamate,
wherein the antisense strand is 15-35 or 20-30 nucleotides in length…….
A method of reducing DUX4 expression in muscle cells of a subject, the method comprising administering to the subject the composition of claim 1.
Both sets of the claims comprising the anti-transferrin R antibody comprising the same VH and VL domain linked to oligonucleotide targeting Double Homeobox 4 (DUX4). The only difference is the anti-transferrin R antibody in the patent ‘525 comprising the heavy and light chains (SEQ ID NOs: 101 and 90) while the antibody in instant application is VH and VL domains (SEQ ID NOs: 76 and 75) within the heavy and light chain of the antibody as evidenced by the sequence alignment below.
QY=SEQ ID NO: 75 (VL):
US-18-063-797-90
Patent No. 11759525
GENERAL INFORMATION
APPLICANT: Dyne Therapeutics, Inc. (en)
TITLE OF INVENTION: MUSCLE TARGETING COMPLEXES AND USES THEREOF FOR TREATING FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY (en)
FILE REFERENCE: D0824.70069US02
CURRENT APPLICATION NUMBER: US/18/063,797
CURRENT FILING DATE: 2022-12-09
NUMBER OF SEQ ID NOS: 158
SEQ ID NO 90
ALIGNMENT:
Query Match 100.0%; Score 563; Length 214;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQMTQSPSSLSASVGDRVTITCRASQDISNFLNWYQQKPGQPVKLLIYYTSRLHSGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSLSASVGDRVTITCRASQDISNFLNWYQQKPGQPVKLLIYYTSRLHSGVPS 60
Qy 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQQGHTLPYTFGQGTKLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLQPEDFATYYCQQGHTLPYTFGQGTKLEIK 107
QY=SEQ ID NO: 76 (VH):
US-18-063-797-101
Patent No. 11759525
GENERAL INFORMATION
APPLICANT: Dyne Therapeutics, Inc. (en)
TITLE OF INVENTION: MUSCLE TARGETING COMPLEXES AND USES THEREOF FOR TREATING FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY (en)
FILE REFERENCE: D0824.70069US02
CURRENT APPLICATION NUMBER: US/18/063,797
CURRENT FILING DATE: 2022-12-09
NUMBER OF SEQ ID NOS: 158
SEQ ID NO 101
ALIGNMENT:
Query Match 100.0%; Score 640; Length 227;
Best Local Similarity 100.0%;
Matches 119; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLQESGPGLVKPSQTLSLTCTVTGYSITSGYYWNWIRQPPGKGLEWIGYITFDGANNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLQESGPGLVKPSQTLSLTCTVTGYSITSGYYWNWIRQPPGKGLEWIGYITFDGANNY 60
Qy 61 NPSLKNRVSISRDTSKNQFSLKLSSVTAEDTATYYCTRSSYDYDVLDYWGQGTTVTVSS 119
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NPSLKNRVSISRDTSKNQFSLKLSSVTAEDTATYYCTRSSYDYDVLDYWGQGTTVTVSS 119
Thus, the reference patents have defined Fc domain of the antibody which has narrower scope.
The method of using the product claimed in the present application would anticipate the presently claimed invention.
The claims of patent ‘525 are silence on the oligonucleotide that is complementary to 3' UTR of a DUX4 sequence of SEQ ID NO: 158 as recited in the instant claim 32.
Subramanian et al in US Patent No.11,111,309 teach a 25 oligonucleotide as single strand nucleotide that complementary to the 3' UTR of RNA of DUX4 as evidenced by sequence alignment as set forth above. Subramanian et al also teach disease FaciosScapulo Humeral Muscular Dystrophy (FSHD) is due the abnormal function of DUX4 and teach TfR antibody complex to deliver the oligonucleotide and methods of inhibiting expression and activity of DUX4 with oligonucleotide for treating such disease (table 1 and page 15-16 and examples).
In order to obtain a composition for treating a FSHD, one skilled in the art would be motivated with reasonable expectation of success to apply the teachings of Subramanian et al including the oligonucleotide to 3’UTR to arrive at current invention, a complex comprising TfR antibody linked to the oligonucleotide, without unexpected result.
Over Application:
Claims 28-45 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of copending Application No. 18/708,815. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are directed to the same complex comprising the same anti-TfR antibody linked to the same oligonucleotide.
The instant claims are drawn as set forth above.
The claims of application ‘815 are drawn to
(Original) A complex comprising an anti-transferrin receptor 1 (TfR1) antibody covalently linked to an oligonucleotide configured for reducing expression or activity of DUX4, wherein the anti-TfR1 antibody comprises a heavy chain complementarity determining region 1 (CDR-H1), a heavy chain complementarity determining region 2 (CDR-H2), a heavy chain complementarity determining region 3 (CDR-H3), a light chain complementarity determining region 1 (CDR-L1), a light chain complementarity determining region 2 (CDR-L2), a light chain complementarity determining region 3 (CDR-L3) of any of the anti-TfR1 antibodies listed in Tables 2-7 and wherein the oligonucleotide comprises an antisense strand comprising a region of complementarity to a DUX4 sequence as set forth in SEQ ID NO: 160 or SEQ ID NO: 365,
Wherein the anti-TfR1 antibody comprises a heavy chain variable region (VH) comprising an amino acid sequence at least 95% identical to SEQ ID NO: 76 and/or a light chain variable region (VL) comprising an amino acid sequence at least 95% identical to SEQ ID NO: 75, optionally wherein the anti-TfR1 antibody comprises a VH comprising the amino acid sequence of SEQ ID NO: 76 and a VL comprising the amino acid sequence of SEQ ID NO: 75,
wherein the Fab comprises a heavy chain comprising an amino acid sequence at least 85% identical to SEQ ID NO: 101 and/or a light chain comprising an amino acid sequence at least 85% identical to SEQ ID NO: 90, optionally wherein the Fab comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 101 and a light chain comprising the amino acid sequence of SEQ ID NO: 90,
wherein the oligonucleotide comprises a region of complementarity of at least 15 consecutive nucleotides to a DUX4 sequence as set forth in SEQ ID NO: 160 or SEQ ID NO: 365, optionally wherein the oligonucleotide comprises a region of complementarity of at least 15 consecutive nucleotides to a DUX4 sequence as set forth in any one of SEQ ID NOs: 161-168 or 213-288.
A method of treating Facioscapulohumeral muscular dystrophy (FSHD), the method comprising administering to a subject in need thereof an effective amount of the complex of claim l any one of claims 1-13, wherein the subject has aberrant production of DUX4 protein, optionally wherein the subject is human.
Both sets of the claims comprising the anti-transferrin R antibody comprising the same VH and VL domain linked to an oligonucleotide targeting Double Homeobox 4 (DUX4) and the same anti-TfR antibody comprising VH and VL domains of SEQ ID NOs: 76 and 75 within the same heavy and light chains of SEQ ID NOs: 101 and 90 as evidenced by the sequence alignment set forth above since they all have the same sequence identifiers (SEQ ID NOs).
Regarding with the oligonucleotide complementarity to 3’UTR of the nucleotides of DUX4, the QY search for an oligonucleotide within the instant SEQ ID NO: 158 (a DUX4 nucleotide sequence) results in an oligonucleotide having the sequence of SEQ ID NO: 173 that is complementary to the 3’UTR of DUX4 nucleotide sequence as evidenced by sequence alignment below. The oligonucleotide sequence of SEQ ID NO: 173 is also recited in claim 8 of the application ‘815.
US-18-708-815-173/c
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 173, US/18708815
Publication No. US20250025570A1
GENERAL INFORMATION
APPLICANT: Dyne Therapeutics, Inc. (en)
TITLE OF INVENTION: MUSCLE TARGETING COMPLEXES FOR TREATING FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY (en)
FILE REFERENCE: D0824.70074US02
SEQ ID NO 173
Query Match 1.5%; Score 25; Length 25;
Best Local Similarity 100.0%;
Matches 25; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1664 TTAGTTCAGAGATATATTAAAATGC 1688
|||||||||||||||||||||||||
Db 25 TTAGTTCAGAGATATATTAAAATGC 1
Thus, both sets of claims encompass the same complex comprising the same anti-TfR antibody with the same VH and VL within the same heavy and light chains linked to an oligonucleotide having the sequence complementary to the same DUX4 nucleotides. Therefore, they are not patentably distinct from each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lei Yao, whose telephone number is (571) 272-3112. The examiner can normally be reached on 8:00am-6:00pm Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEI YAO/Primary Examiner, Art Unit 1642