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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/16/26 has been entered.
Applicant’s election without traverse of SEQ ID NO:33948 as the IRES and SEQ ID NO: 28977 as the sequence that is complementary to an 18S rRNA in the reply filed on 4/29/25 is acknowledged. It is noted that the sequences of claim 54 have been rejoined.
Claim Objections
Claims 52, 53, 58, 59, and 64-66 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.
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 42, 43, 46-49, 51, 54-56, 61-63, 67, and 70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,560,567 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US ‘567 are directed to a recombinant circular RNA molecule comprising a protein-coding nucleic acid sequence and an IRES sequence region operably linked to the protein-coding sequence, wherein the IRES sequence region comprises at least one RNA secondary structure element and a sequence that is complementary to an 18S rRNA, which are elements required by the instant claims. US ‘567 recites that the secondary structure is at the same position as instantly claimed and the claim sets recite overlapping size limitations for the IRES. The specification of US ‘567 defines the secondary structure as including stem loop structured RNA elements and the polynucleotide being comprised within a viral vector. The claims are obvious variations of each other.
The species are obvious variations of the patented genus and the species anticipates the genus covering it.
Response to Arguments
Applicant argues that claim 1 of patent ‘567requies for the IRES sequence region to have a minimum free energy of less than -18.9 kJ/mol and a melting temperature of at least 35.0 degrees C and therefore the claims are patentably distinct.
Contrary to applicant’s argument, recitation of MFE and melting temperature is not a clear structural difference between the instant compound and the compound of the conflicting patent. Both claim sets are directed to circular RNAs comprising a protein-coding sequence and an IRES sequence region (instant claim 42; claim 1 of patent ‘567), wherein the IRES sequence region is operably linked to the protein-coding sequence (instant claim 42; claim 2 of patent ‘567), wherein the IRES sequence comprises a RNA secondary structure element (instant claim 42; claim 1 of patent ‘567), wherein the RNA secondary structure element is a stem-loop formed from nucleotides at position 40 to position 60 (instant claim 42; claims 3 and 4 of patent ‘567) and at least one sequence region having complementarity to one or more active regions in 18S rRNA (instant claims 42 and 67; claims 5 and 6 of patent ‘567). Instant claim 43 requires for the IRES sequence region to have a GC content of greater than 25% (claim 8 of patent ‘567). Incorporation of lipid nanoparticles and targeting agents is obvious and a matter of design choice (instant claims 46-49 and 61-63). Instant claim 51 requires for the IRES sequence region to be about 200 to about 1000 nucleotides in length, which is anticipated by the lengths of claim 9 of patent ‘567. The sequences of instant claim 54 are disclosed in the specification of patent ‘567 as the IRES sequences of claim 1 and therefore define the recited IRES. Instant claims 55 and 56 are directed to spacers (claims 11 and 2 of patent ‘567).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amy R Hudson whose telephone number is (571)272-0755. The examiner can normally be reached M-F 8:00am-6:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY ROSE HUDSON/Primary Examiner, Art Unit 1636
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