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. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/21/2026 has been entered.
3. Claims 53-56, 61-63, 66 and 73-82 are pending.
Claims 53-56, 61-63 and 66 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Inventions, there being no allowable generic or linking claim.
Claims 73-82 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)(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 73-82 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wesselhoeft et al. (US 20240042015).
Instant claim 73 is recited as follows:
An immunogenic composition comprising a circular polyribonucleotide comprising from 5' to 3':
(i) a first spacer,
(ii) a first IRES;
(iii) a first sequence encoding a first herpes simplex virus (HSV) antigen;
(iv) a second IRES;
(v) a second sequence encoding a second HSV antigen; and
(vi) a second spacer.
Wesselhoeft teaches a circular RNA molecule comprising:
a first spacer sequence,
a first IRES,
a first expression sequence,
a second IRES,
a second expression sequence, and
a second spacer sequence (e.g. [0234]-[0236]).
The circular RNA constitutes a vaccine (e.g. [0044]), i.e. an immunogenic composition, in particular a multivalent vaccine (e.g. [0046]), wherein the first expression sequence encodes a first viral antigenic polypeptide and the second expression sequence encodes a second viral antigenic polypeptide (e.g. [0047]), such as Herpes simplex type 1 polypeptide or Herpes simplex type 2 polypeptide (e.g. [0044]). These teachings anticipate instant claims 73 and 75.
The vaccine comprises one or more circular RNA polynucleotides encoding three or four antigens (e.g. [0370]). In particular embodiments, the vaccine comprises at least two circular RNA polynucleotides each encoding a viral antigen (e.g. [0056]). These teachings anticipate instant claims 76-81.
In particular embodiments, the vaccine comprises a lipid nanoparticle (e.g. [0034]) and/or an adjuvant (e.g. [0052]). These teachings anticipate instant claims 74 and 82.
Additional teachings of the subject matter exemplified above are found in claims 1-5, 50, 69-74, 82-90, and 141-144, and paragraphs [0006]-[0010], [0039]-[0041], [0051], [0135]-[0137], [0140], [0150], [0185], [0188], [0220]-[0228], [0250]-[0253], [0259], [0265]-[0267], [0301]-[0304], [0462]-[0463], and [0591]-[0594].
Accordingly, Wesselhoeft teaches all of the limitations of claims 73-82, and as such anticipates these claims.
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 73-82 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of each of U.S. Patents No. 10953033 and 11058706 (both of record) in view of Wesselhoeft et al. (US 20240042015).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the claims of each of the above-listed patents in view of Wesselhoeft.
US ‘033 recites a circular polyribonucleotide comprising an expression sequence encoding a polypeptide and an IRES (claim 1), wherein the expression sequence encodes a viral antigen (claims 11-13), wherein the circular polyribonucleotide is formulated with a lipid nanoparticle (claim 24), wherein the circular polyribonucleotide further comprises a second expression sequence encoding a second polypeptide (claim 36).
US ‘706 recites a circular polyribonucleotide comprising an expression sequence encoding a polypeptide and an IRES (claim 1), wherein the circular polyribonucleotide further comprises a second expression sequence encoding a second polypeptide (claim 10), wherein the circular polyribonucleotide is formulated with a lipid nanoparticle (claim 17), wherein the polypeptide is a viral antigen (claims 20-22).
Before the effective filing date of the claimed invention, a person of ordinary skill in the art would have been aware that in the absence of a typical RNA cap structure, translation of an open reading frame from a circular RNA molecule requires an IRES to attract eukaryotic ribosomal translation initiation complex, as mentioned e.g. by Wesselhoeft at [0185] and [0225]. Therefore, it would be clear to a skilled artisan that circular RNA comprising two expression sequences would require an IRES element 5’ of each expression sequence. It was also routine in the art to use spacer sequences to separate structural or functional elements of expression constructs. Therefore, the structural features of the circular polyribonucleotide recited in instant claim 73 would be at once envisaged by, or at least obvious to, a person of ordinary skill in the art in view of the claims of each of US ‘033 and US ‘706.
Since each of US ‘033 and US ‘706 recites viral antigens expressed from circular RMA molecules, it would be clear to a skilled artisan that the molecule would function as a vaccine, i.e. an immunogenic composition. While the above patents do not specifically recite HSV antigens, it would have been obvious to a person of ordinary skilled in the art to include them in the vaccine recited in the claims of each of the patents, because HSV is a widespread common pathogen known to be preventable by vaccination, and further in view of Wesselhoeft’s teachings exemplifying such vaccines, as pointed out in section 5 above.
The limitations of instant claims 76-81 would have been obvious to a person of ordinary skill in the art in view of the claims of each of the patents based on art-recognized advantages of polyvalent vaccines, and further in view of Wesselhoeft’s teachings exemplifying such vaccines, as pointed out in section 5 above.
The limitations of instant claim 82 would have been obvious to a person of ordinary skill in the art in view of the claims of each of the patents, because the use of adjuvants in vaccine compositions was routine in the art before the effective filing date of the claimed invention, and further in view of Wesselhoeft’s teachings pointed out in section 5 above.
8. Claims 73-82 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of the following copending applications (all of record) in view of Wesselhoeft et al. (US 20240042015):
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 obvious over the claims of each of the copending applications in view of Wesselhoeft. Each of the copending applications recites circular polyribonucleotides encoding polypeptide antigens, which make instant claims obvious for the same reasons as articulated in section 8 above.
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, which teach various aspects of the claimed invention, are cited of record but not presently relied upon:
US Pat. Pub. No. 20230136960, and
US Pat. Pub. No. 20160317647.
10. Conclusion: no claim is allowed.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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