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 without traverse of Group I, claims 1-9 in the reply filed on 11/11/2025 is acknowledged.
Status of the Application
This is a Track 1 application. Claims 1-23 are pending. Claims 1-9 are currently under examination. Claims 10-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-9 and sequences having SEQ ID Nos. 281, 283, 284, 286-288, 76 and 6 have been examined and are free of the prior art in the context of the claims as explained below.
Information Disclosure Statement
The submission of the Information Disclosure Statements on 07/29/2025 and 11/11/2025 is in compliance with 37 CFR 1.97. The information disclosure statements have been considered by the examiner and signed copies have been placed in the file.
Drawings
The drawings submitted on 07/11/2025 are not acceptable because: the text for the x axis in Figure(s) 7-9, 11A-B and 13-15 is in small font and not legible, thus is not electronically reproducible. See 37 CFR 1.84(I). Replacement drawing sheets in compliance with 37 CFR 1.84 and 1.121(d) containing figures that are of sufficient quality to be electronically reproduced are required.
MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of Patent No. 12,486,328 (Patent ‘328). Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims and Patent ‘328 are drawn to a conjugate comprising an anti-transferrin antibody, an siRNA and a linker wherein the antibody has a VH region and a VL region. Both the siRNA of the instant claims and Patent ‘328 target region 61-79 of NM_001306068 (see Table page 118 of Patent ‘328) and thus the claims overlap in scope and are not patentably distinct from each other because it would have been obvious to use each of the siRNA to target the same region.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of Patent Application No. 18,866,147 (App ‘147). Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1-17 and 20-24 and App ‘147 are drawn to a conjugate comprising an anti-transferrin antibody, an siRNA and a linker wherein the antibody has a VH region and a VL region having the same sequences and the siRNA can comprise an antisense strand having SEQ ID No. 76.
Regarding claims 18-19 and 25-33 of App ‘147 drawn to methods of modulating human DUX4 using the claimed conjugate, it would have been obvious to use in the conjugate of the instant claims in the methods of App ‘147 given the conjugate is described in each of the specifications as targeting the DUX4 gene between nucleotides 61-79. The Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001 at page 1008 (March 2008), indicated that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application.
Closest prior art
The siRNA sequences having SEQ ID No. 76 and 6 are free of the prior art in the context of the claim. The prior art reference of Harper et al. (US Patent No. 10,301,649) teach a single stranded oligonucleotide identical to instantly claimed SEQ ID No. 76 having SEQ ID No. 1949 (see alignment below):
; Publication No. US20170029849A1
; APPLICANT: Harper, et al.
; SEQ ID NO 1949
; LENGTH: 19
; TYPE: RNA
; ORGANISM: Homo sapiens
US-15-295-591-1949
Query Match 100.0%; Score 19; DB 67; Length 19;
Best Local Similarity 78.9%;
Matches 15; Conservative 4; Mismatches 0; Indels 0; Gaps 0;
SEQ 76 1 TCCAAACGAGTCTCCGTCG 19
:|||||||||:|:|||:||
SEQ 1949 1 UCCAAACGAGUCUCCGUCG 19
Harper et al. teach this single stranded nucleotide is a miRNA antisense guide strand that targets DUX4 but does not teach a reason to use this sequence to make a siRNA for use in the claimed conjugate along with an anti-transferrin antibody with the claimed variable heavy and light chains as claimed. Harper et al. does not identify a problem to be solved such that one of skill in the art would try and make an siRNA from this sequence given these miRNA guide strands were shown to efficiently inhibit expression of the DUX4 gene (see Example 3).
Sugo et al. (J. Controlled Release 237 (2016) 1-13) teach development of an antibody-siRNA conjugate that was capable of efficiently targeted muscle cells (see Abstract) wherein the antibody is an anti-transferrin antibody. Sugo et al. do not teach an anti-transferrin antibody comprising a variable heavy chain and a variable light chain with the claimed sequences and the prior art does teach these sequences with the motivation to combine with an anti-transferrin antibody and siRNA having SEQ ID Nos. 76 and 6 for the purpose of targeting a DUX4 gene. Further the prior art does not teach these variable heavy chain and variable light chain sequences with the mutations as in claims 7 and 8.
Thus while inhibitory and siRNA sequences are known and anti-transferrin antibodies are known for use with siRNA, it would not have been obvious to one of ordinary skill in the art to make the anti-transferrin antibody with the variable heavy chain and light chain sequences as claimed. The prior art does not identify a design need or market pressure to solve a problem with an anti-transferrin antibody and does not identify the claimed variable heavy chain and light chain sequences as having any benefit for use with the anti-transferrin antibody. Therefore a person of ordinary skill would not have a good reason to identify these heavy and light chain sequences, from any other heavy and light chain sequences and modify the anti-transferrin antibody for use in an siRNA conjugate to target a DUX4 gene.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Chong at (571)272-3111. The examiner can normally be reached Monday thru Friday between M-F 8:00am-4:30pm.
If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public. For more information about the PAIR system, see http://pair-direct.uspto.gov.
For all other customer support, please call the USPTO Call Center (UCC) at 800-786-9199.
/KIMBERLY CHONG/
Primary Examiner Art Unit 1636