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 .
Application Status – Continued Examination Under 37 CFR 1.114
Claims 1 and 29-80 were previously pending.
A final rejection office action was mailed on 19 March 2026.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 18 June 2026 has been entered.
In their request for continued examination, Applicant has amended claims 34, 38, 54, 57-58, and 76 and did not cancel or add claims.
Therefore, claims 1 and 29-80 remain pending and are under examination.
Priority
Acknowledgment is made for the following priority:
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Terminal Disclaimer
The terminal disclaimer filed on 18 June 2026 filed for the following patents has been reviewed and accepted:
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The terminal disclaimer has been recorded.
Information Disclosure Statement (IDS)
The IDS (1) filed on 18 June 2026 has been considered by the examiner. A signed copy is enclosed.
Withdrawn Claim Objections/Rejections
I. Claims 38 and 76 were previously objected to.
II. Claim 34 was previously rejected under 35 USC 112(b).
Applicant’s amendments to the claims were sufficient to overcome all previous claim objections/rejections of record and the aforementioned objections/rejections are hereby withdrawn.
New Claim Rejections
Claim Rejections - 35 USC § 112(b)
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 and 29-80 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “…and wherein the oligonucleotide induces dystrophin (DMD) exon skipping.” DMD a common abbreviation for Duchenne Muscular Dystrophy, not dystrophin. Dystrophin is a protein encoded by the DMD gene and is central to other conditions such as Becker Muscular Dystrophy (BMD).
Therefore, it is unclear whether claim 1 is directed to dystrophin as pertaining to DMD, dystrophin generally, or the DMD gene encoding dystrophin. If directed to the DMD gene specifically, a mandatory claim limitation cannot be contained within parenthesis. One of ordinary skill could not reasonably ascertain whether the parenthetical expression “DMD” constitution a required limitation of the claimed invention or merely provides a non-limiting limitation. Claims 29-80 are included in this rejection for depending on, requiring all the limitations of, and failing to cure the defect recited in instant claim 1.
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.
Co-pending application 19/679,948
Claims 1 and 66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, 22, 23, 26, and 27 of copending Application No. 19/679,948 (‘948) in view of Nowak (“Duchenne muscular dystrophy and dystrophin: pathogenesis and opportunities for treatment,” published 01 September 2004). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are drawn to a complex comprising an identical anti-transferrin receptor (TfR) antibody covalently linked to an oligonucleotide.
Claims 1, 2, 10, 26, and 27 of ‘948 read on claim 1 of the instant application. Specifically, the aforementioned claims of ‘948 are directed to an anti-TfR antibody covalently linked to an oligonucleotide. The antibody of ‘948, as claimed by a VH of SEQ ID NO: 76 and a VL of SEQ ID NO: 75, is identical to the antibody of instant claim 1 as depicted in a comparison below:
SEQ ID NO: 75 of both the instant application and ‘948:
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SEQ ID NO: 76 of both the instant application and ‘948:
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The co-pending claim recites a broader genus of an oligonucleotide configured to modulate the expression or activity of a muscle disease gene wherein the muscle disease is selected from Duchenne Muscular Dystrophy (DMD) (‘948 claim 27).
In addition, claims 22 and 23 of ‘948 read on claim 66 of the instant application. Specifically, the aforementioned claims of ‘948 are directed to the cleavable linker comprising a valine-citrulline sequence.
The presently examined claims differ from ‘948 in that instant claim 1 recites the oligonucleotide induces dystrophin gene exon skipping. The dystrophin gene constitutes a muscle disease gene, as recited in ‘948, because pathogenic alterations in the dystrophin gene cause DMD. Inducing exon skipping in the dystrophin gene constitutes modulation of dystrophin gene expression, as recited in ‘948, because exon skipping alters processing of the dystrophin transcript and therefore modifies production of the encoded dystrophin protein.
Nowak evidences that, before the effective filing date of the claimed invention, the dystrophin gene was a recognized muscle disease gene whereby mutations in the gene cause Duchenne Muscular Dystrophy (abstract). Nowak further teaches that exon skipping of mutations induced using oligonucleotides is a known gene therapy (abstract). It would have been obvious to a person of ordinary skill to selected the dystrophin gene as the muscle disease gene recited in claim 1 of ‘948 and configure the oligonucleotide to induce exon skipping with a reasonable expectation of success in modulating dystrophin expression. The presently claimed oligonucleotide is therefore an obvious species of the broader oligonucleotide claimed in ‘948.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1 and 29-80 are rejected. No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A. Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-Th 7:30-5:30 (MST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571)272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights