Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Applicant's amendments and remarks filed on November 12, 2025 is acknowledged. Claims 1-529 have been canceled. Claim 550 was amended. Claims 530-550 are pending and are examined on the merits herein.
Priority
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Withdrawn Objections
In view of Applicant’s amendments and response, the objection to the drawings is withdrawn.
Withdrawn Rejections
In view of Applicant’s amendments and response, the 35 U.S.C 112(a) enablement rejection is withdrawn.
Drawings
The drawings were received on November 12, 2025. These drawings are found acceptable by the examiner.
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.
Claims 530-550 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,023,861 in view of Bennett et al. (6,140,126).
The instant application claims an oligomeric compound comprising an oligonucleotide consisting of 10-30 linked nucleosides and at least one conjugate group wherein the oligonucleotide comprises at the 5’ position a moiety having one of the formulas
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and patent ‘861 claims a compound comprising an oligonucleotide consisting of 10-30 linked nucleosides and at least one conjugate group wherein the 5’-terminal nucleoside of the oligonucleotide has Formula IV:
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.
The instant application also claims a method of inhibiting protein expression in a cell comprising contacting the cell with the oligomeric compound according to claim 530.
However, patent ‘861 does not claim a method of inhibiting protein expression in a cell comprising contacting the cell with the oligomeric compound of any of claims 1-21.
Bennett et al. teaches a method of inhibiting the expression of Y-box binding protein 1 in human cells or tissues in vitro comprising contacting said cells or tissues in vitro with the antisense compound of claim 3 so that the expression of Y-box protein 1 is inhibited [claim 26]. Bennett et al. teaches that antisense oligonucleotides are able to inhibit gene expression with exquisite specificity and are often used by those of ordinary skill to elucidate the function of particular genes [column 6, first full paragraph].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to contact a cell with the oligomeric compound of patent ‘861 to inhibit protein expression in a cell as taught by Bennett et al. One would have been motivated to do so because Bennett et al. teaches that antisense oligonucleotides are able to inhibit gene expression with exquisite specificity and are often used by those of ordinary skill to elucidate the function of particular genes.
Response to Arguments
Applicant's arguments filed November 12, 2025 have been fully considered but they are not persuasive.
Applicant requests that the nonstatutory double patenting rejection be held in abeyance until the claims are otherwise allowable and will consider filing a Terminal Disclaimer at that time. Thus, the Examiner is maintaining the nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 CHRISTINA TRAN whose telephone number is (571)270-0550. The examiner can normally be reached M-F 7:30 - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.T./
Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637