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 .
The Amendment filed 12/11/25 has been received, entered into the record, and carefully considered. The following information provided in the amendment affects the instant application by:
Claims 9, 17, and 37 have been amended.
No claims have been added.
Claims 1-8, 10-11, 13, 16, 18-19, 22, 24, 26, 28, 32, 36, 38, 40-43, 45-53, and 55-81 have been canceled.
Remarks drawn to rejections of Office Action mailed 9/19/25 include:
112 2nd paragraph rejections: which have been overcome by applicant’s amendments and have been withdrawn.
112 1st paragraph rejections: which have been overcome by applicant’s amendments and have been withdrawn.
Double Patenting Rejections: which have been maintained for reasons for record.
An action on the merits of claims 9, 12, 14-15, 17, 20, 21, 23, 25, 27, 29-31, 33-35, 37, 39, 44, and 54 is contained herein below. The text of those sections of Title 35, US Code which are not included in this action can be found in a prior Office action.
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.
The provisional rejection of claims 9, 12, 14, 15, 20, 23, 25, 27, 29-31, 33-34, 37, 39, 44, and 54 on the ground of nonstatutory double patenting as being unpatentable over claim 22-24 of copending Application No. 18/572,745 (reference application) is maintained for reasons of record. Although the claims at issue are not identical, they are not patentably distinct from each other because the siRNA conjugate linkers in ‘745 would anticipate the linkers claimed herein. The linkers in ‘745 have structures such as:
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which is the same compound elected herein and claimed in claims 34 and 39 herein. Likewise, both applications are drawn to linking these compounds to R2 wherein R2 is an ANGPTL3- siRNA oligonucleotide comprising the same sense and antisense strands. A skilled artisan would find the present claims prima facia obvious in view of ‘745 and see the applications are substantially overlapping.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicants did not argue this rejection and requested it be held in abeyance until the claims are otherwise in condition for allowance.
It is noted the MPEP states that if both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application or includes a compliant terminal disclaimer in the application under37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted. 18/572,745 and the present application both have the same patent term filing date.
The provisional rejection of claims 9, 12, 14, 15, 20, 21, 25, 27, 29-31, 33-34, 37, 39, 44, and 54 on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 19/157,889 (reference application) is maintained for reasons of record. Although the claims at issue are not identical, they are not patentably distinct from each other because the siRNA conjugate linkers in ‘889 would anticipate the linkers claimed herein. The linkers in ‘745 have structures such as:
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which is the same compound elected herein and claimed in claims 34 and 39 herein. Likewise, both applications are drawn to linking these compounds to R2 wherein R2 is a PCSK9-siRNA oligonucleotide comprising the same sense and antisense strands. A skilled artisan would find the present claims prima facia obvious in view of ‘889 and see the applications are substantially overlapping.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicants did not argue this rejection and requested it be held in abeyance until the claims are otherwise in condition for allowance.
Allowable Subject Matter
Claims 17 and 35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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 TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TRAVISS C. MCINTOSH III
Primary Examiner
Art Unit 1693
/TRAVISS C MCINTOSH III/ Primary Examiner, Art Unit 1693