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 .
Claims 1, 3-14 and 31-33 are pending and being acted upon in this Office Action.
Priority
Applicant’ claim priority to provisional application 63/327,725, filed April 5, 2022, is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 3, 2026 has been considered by the examiner and an initialed copy of the IDS is included with this Office Action.
Specification
The erroneous substitute specification filed September 16, 2025 will not be entered because of new matter. In particular, the specification is related to a different subject matter, not anti-transferrin receptor antibody-PMO conjugates for inducing DMD exon 44 skipping. A continuation application should have same specification as the 18/130,757 application.
Applicants should amend the first line of the specification to update the relationship between the instant application and U.S. Application No. 19/234,136, filed June 10, 2025, now U.S. Patent No. 12,648,998.
Objection and Rejection Withdrawn
The objection to claims 1, 8, 9 and 25 is withdrawn in view of the claim amendment.
The written description rejection of claims 1-13, 15-27, 29 and 30 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn in view of the amendment to claim 1.
The rejection of claims 15 and 17-26 under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Levin et al (US20180369400, published December 27, 2018; PTO 892) is withdrawn in view of the claims have been canceled.
The rejection of claims 15 and 27-29 under 35 U.S.C. 103 as being unpatentable over Levin et al (US20180369400, published December 27, 2018; PTO 892) in view of US patent No. 10,913,800 (issued February 9, 2021; PTO 892) is withdrawn in view of the claims have been canceled.
The rejection of claims 16 and 23 under 35 U.S.C. 103 as being unpatentable over Levin et al (US20180369400, published December 27, 2018; PTO 892) in view of US patent No. 10,913,800 (issued February 9, 2021; PTO 892) as applied to claims 15 and 27-29 above and further in view of WO2019060775 publication (published March 28, 2019; PTO 892) is withdrawn in view of the claims have been canceled.
The rejection of claims 1, 3-4 and 6-12 under 35 U.S.C. 103 as being unpatentable over Levin et al (US20180369400, published December 27, 2018; PTO 892) in view of Alley et al (US20090010945, published January 8, 2009; PTO 892), Hanson et al (US20120065169, published March 15, 2012; PTO 892) and Scheer (US20110287009, published November 24, 2011; PTO 892) is withdrawn in view of the claim amendment. In particular, the references above do not teach the PMO consists of SEQ ID NO: 118.
The rejection of claims 2 and 5 under 35 U.S.C. 103 as being unpatentable over Levin et al (US20180369400, published December 27, 2018; PTO 892) in view of Hanson et al (US20120065169, published March 15, 2012; PTO 892) and Scheer (US20110287009, published November 24, 2011; PTO 892) as applied to claims 1, 3-4 and 6-12 and further in view of WO2019060775 publication (published March 28, 2019; PTO 892) is withdrawn in view of the amendment to claim 1. The addition of WO2019060775 publication does not cure the deficiency of Levin, Hanson and Scheer.
The rejection of claims 13-14 and 30 under 35 U.S.C. 103 as being unpatentable over Levin et al (US20180369400, published December 27, 2018; PTO 892) in view of Hanson et al (US20120065169, published March 15, 2012; PTO 892) and Scheer (US20110287009, published November 24, 2011; PTO 892) as applied to claims 1, 3-4 and 6-12 and further in view of US patent No. 10,913,800 (issued February 9, 2021; PTO 892) is withdrawn in view of the amendment to claim 1. The addition of the ‘800 patent does not cure the deficiency of Levin, Hanson and Scheer.
The rejection of claims 1-30 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of US Patent No. 12648998 (Application No. 19/234,136) is withdrawn in view of the terminal disclaimer filed on September 3, 2026.
The rejection of claims 1-30 on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,359,202 is withdrawn in view of the terminal disclaimer filed on September 3, 2026.
The rejection of claims 1-30 on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,071,621 is withdrawn in view of the terminal disclaimer filed on September 3, 2026.
New ground of rejection necessitated by the amendment filed September 3, 2026
Claim rejections under - 35 U.S.C. 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 32 is rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention. This is New Matter.
The structure
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134
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has no written support in the specification and the claims as originally filed. This is new matter.
Amending claim 32 to recite “…wherein the linker comprises 4-(N-maleimidomethyl) cyclohexane-1-amidate (SMCC)” would obviate this rejection. See specification para. [0187].
Conclusion
Claims 1, 3-14, 31 and 33 are allowed.
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 PHUONG HUYNH whose telephone number is (571)272-0846. The examiner can normally be reached on 9:00 a.m. to 6:30 p.m. The examiner can also be reached on alternate alternative Friday from 9:00 a.m. to 5:30 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Misook Yu, can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-272-0839.
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/PHUONG HUYNH/ Primary Examiner, Art Unit 1641
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