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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 9/17/2025 is acknowledged.
Claims 220, 221, and 223-242 are pending.
Claims 240-242 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/17/2025.
Claims 220, 221, and 223-239 are examined.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 220, 221 and 223-239 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khvorova et al (US20050255487) in view of McSwiggen et al (US9181551) and Bettencourt et al (US9133461).
Khvorova et al have taught SEQ ID NO:62516 which corresponds to SEQ ID NO:382. SEQ ID NO:62516 is taught to be a target sequence for siRNA design. One in the art would clearly have known to make siRNA compounds comprising SEQ ID NO:62516 since the prior art clearly suggested to do so. Khvorova et al have also taught to make siRNA compounds of various sizes including 20mers. It has also been taught to utilize conjugates for cell delivery as well as various chemical modifications to provide for more effective administration to cells and for stability of the oligonucleotides. Buffers have also been taught. While the entire reference is relied upon and relevant, applicant is directed to paragraphs 79, 108, 127-129, 135, 137, 412, 416, 439, 444, and 445. Khvorova et al do not specifically teach N-acetylgalactosamine as a conjugate.
Both McSwiggen et al and Bettencourt et al have taught N-acetylgalactosamine as conjugates for siRNA delivery. It has also been taught, pharmaceutically acceptable carriers as well as modifications and size ranges of the instant invention. While both references are relied on as a whole, applicant is directed to the claims of the patents.
One in the art would clearly have been motivated to make siRNA compounds comprising N-acetylgalactosamine conjugates since the prior art has clearly taught that such conjugates aid in cellular delivery, for example. It is noted that while to compounds of the prior art are ultimately utilized as double stranded compounds, one in the art would clearly make single stranded complements in the construction of the double stranded compounds of the prior art.
The invention as a whole would have been prima facie obvious to one in the art at the time the application was effectively filed.
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 220, 221, and 223-239 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 9,670,492. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim antisense compounds based on SEQ IDS:571-575. The claims anticipate and render each other obvious. See claim 18 of the patent and claim 1 of the application, for example.
Claims 220, 221, and 223-239 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,613,752. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim antisense compounds based on SEQ ID: 1117. The claims anticipate and render each other obvious. See claim 1 of the patent and claim 1 of the application, for example.
Claims 220, 221, and 223-239 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,100,310. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim antisense compounds based on SEQ IDS:571-575. The claim 234 of the application anticipates claim 1 of the patent since at least SEQ ID:129 of the application targets within the recited target sequence and it would have been obvious to make SEQ ID NO:129 based on the teachings of the claims of the patent.
Claims 220, 221, and 223-239 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,053,500. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim antisense compounds based on SEQ IDS:334, 495, 587, 598, 635, 1349, 1352, 1389, 1516, 1544, 1548, 1569, 1617, 1804, 1881, and 2019. The claims anticipate and render each other obvious. See claim 18 of the patent and claim 1 of the application, for example.
Claims 220, 221, and 223-239 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 61-90 of copending Application No. 18/489,316 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the applications are drawn to the same antisense oligonucleotides. Both appllications are drawn to antisense compounds targeting the same gene. Claim 1 of the instant application claims antisense compounds that are based on SEQ ID NOS:642 and 645. The reference application claims antisense compounds based on SEQ ID NOS:643 and 644. SEQ ID NO: 642 comprises at least 8 nucleotides of SEQ ID NO:643 and both share 100% complementary to SEQ ID NO:10 (target nucleotide sequence). SEQ ID NO: 645 comprises at least 8 nucleotides of SEQ ID NO:644 and both share 100% complementary to SEQ ID NO:10 (target nucleotide sequence). SEQ ID NOS: 643 comprises at least 18 nucleotides of SEQ ID NO:642 and both share 100% complementary to SEQ ID NO:10 (target nucleotide sequence). SEQ ID NOS: 644 comprises at least 18 nucleotides of SEQ ID NO:644 and both share 100% complementary to SEQ ID NO:10 (target nucleotide sequence). The claims of the application anticipate and render each other obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN MCGARRY whose telephone number is (571)272-0761. The examiner can normally be reached M-Th/F 9:00-7:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ram Shukla can be reached at 571 272 1600. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN MCGARRY/Primary Examiner, Art Unit 1635