DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's amendment and remarks filed on 12/01/2025 are acknowledged.
Claims 53-56, 61-63, 66 and 73-74 are pending.
3. Claims 53-56, 61-63 and 66, as presently amended, are directed to an invention that is independent or distinct from the originally claimed invention for the following reasons:
The originally presented invention is directed to an immunogenic composition comprising a circular polyribonucleotide comprising a sequence encoding an HSV antigen. The invention of claims 53-56, 61-63 and 66, as presently amended, is directed to an immunogenic composition comprising a plurality of sequences, each encoding an antigen, wherein at least one sequence encodes an HSV antigen, wherein the plurality of sequences are each separated by a stagger element. The two inventions are directed to different products, which are patentably distinct because their components, structures, physicochemical properties and/or mode of action are different, and they require non-coextensive searches in the scientific literature. Therefore, each product is patentably distinct, and examination of these Inventions together would impose an undue burden.
Since Applicant received an action on the merits for the originally presented invention, that invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 53-56, 61-63 and 66 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Claims 73 and 74 are presently under consideration.
4. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
5. Claims 73-74 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Chang et al. (US 20190345503, of record).
As addressed in section 8 of the previous office action, Chang teaches a circular polyribonucleotide comprising an IRES operably linked to a sequence encoding an immunogenic polypeptide (i.e. antigen) (claim 7), wherein the immunogenic polypeptide is derived from a virus (claim 8) such as herpesvirus, e.g. HSV-I or HSV-II (e.g. [0142], [0146]). A person of skill in the art would be aware that an IRES operably linked to a coding sequence is located 5’ of the coding sequence. The term “spacer” in claim 73 is not defined, and therefore is assumed to include any portion of the circular polyribonucleotide which is not a specifically defined element. Accordingly, claim 73 is anticipated by Chang’s teachings.
Chang further teaches that circular RNA is delivered with a lipid nanoparticle (e.g. [0014], [0027]), thereby anticipating claim 74.
6. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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/patent/patents-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 www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
7. Claims 73-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patents No. 10953033 and 11058706 (both of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by or obvious over the claims of each of the patents, which recite circular polyribonucleotides comprising IRES and encoding a viral antigen, formulated with a lipid nanoparticle (claims 1, 11-13 and 24 of US ‘033 and claims 1, 17 and 20-22 of US ‘706).
Since herpes simplex virus (HSV) infection is common and known to be prevented by vaccination, a skilled artisan would at once envisage HSV antigens as viral antigens recited in patent claims, and those skilled in the art would have been motivated to express HSV antigens as viral antigens recited in patent claims.
8. Claims 73-74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of the following copending applications (all of record):
USSN US PG Pub
18/283262 20250188505
18/723239 20250051386
18712809 20250032604
18/283257 20240263206
18/283242 20240181079
18/024542 20240009298
17/925966 20230193311
17/433639 20220143062
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by or obvious over the claims of each of the copending applications, which recite circular polyribonucleotides comprising IRES and encoding polypeptides.
Since most polypeptides are antigenic, and since expressing HSV antigens from circular RNA for immunization was known in the art, as evidenced e.g. by Chang et al. (US 20190345503) described in section 5 above, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to express HSV antigens as the polypeptides recited in the claims of the copending applications.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
9. The following prior art references, cited of record but not presently relied upon, teach most or all of the limitations of the present claims:
US 20160194368
US 20170204422
US 20210292761
US 20210371494
US 20220323480
10. Conclusion: no claim is allowed.
11. 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.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 8:30 AM – 5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached at 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644