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 II, claims 9-12 and 21 in the reply filed on December 11, 2025 is acknowledged.
Claims 9-12 and 21 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 3, 2023, June 3, 2025, July 28, 2025 and have been considered by the examiner.
Claim Rejections - 35 USC § 102
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.
Claims 9-12 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mogler et al. (WO 2019/121513 in IDS on 4/3/2023).
Mogler et al. disclose an RNA replicon particle comprising a nucleic acid construct comprising a first sequence, a second sequence, and a third nucleic acid sequence encoding a first, a second and a third neuraminidase (NA) antigen, respectively, of a Swine influenza A virus (IAV-S), wherein the first NA antigen is of the A/swine/Scotland/410440/1994-like H1huN2 (Scot/94) lineage, the second NA antigen is of the A/swine/Gent/1/1984-like H3N2 (Gent/84) lineage, and the third NA antigen is selected from the A(H1N1)pdm09 (pdm09) lineage or the Eurasian avian- like HlavN1 (EA) lineage (see pages 10-15, Materials and Methods on pages 40-55 Including Examples 1-5 and claims 1-26).
Regarding present claims 10-12. Mogler et al. disclose RNA replicon particle of claim 10, which is a Venezuelan Equine Encephalitis Virus (VEEV) alphavirus RNA replicon particle (see page 16, first paragraph).
Regarding present claim 21. Mogler et al. disclose a method of immunizing a porcine against a swine influenza A virus, comprising administering to the porcine an immunologically effective amount of the vaccine (see page 31, first paragraph, Examples 1-5 and claim 26).
Thus, by this disclosure Mogler et al. anticipate the present 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 §§ 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.
Claims 9-12 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No.12,290,556. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to an RNA replicon particle comprising a nucleic acid construct comprising a first sequence, a second sequence, and a third nucleic acid sequence encoding a first, a second and a third neuraminidase (NA) antigen, respectively, of a Swine influenza A virus (IAV-S), wherein the first NA antigen is of the A/swine/Scotland/410440/1994-like H1huN2 (Scot/94) lineage, the second NA antigen is of the A/swine/Gent/1/1984-like H3N2 (Gent/84) lineage, and the third NA antigen is selected from the A(H1N1)pdm09 (pdm09) lineage or the Eurasian avian- like HlavN1 (EA) lineage .
The claims of the U.S. Patent No.12,290,556 are drawn to a vaccine for administration to a porcine comprising a first alphavirus RNA replicon particle that encodes a first swine influenza A virus (IAV-S) neuraminidase (NA) or an antigenic fragment thereof and a second alphavirus RNA replicon particle that encodes a second IAV-S NA or an antigenic fragment thereof, and a pharmaceutically acceptable carrier; with the proviso that the vaccine neither comprises an IAV-S hemagglutinin (HA) or an antigenic fragment thereof, nor a nucleotide sequence that encodes the IAV-S HA or the antigenic fragment thereof; and wherein the first NA and the second NA comprise amino acid sequences that have 98% identity or less. The specification of U.S. Patent No.12,290,556 discloses the presently claimed IAV-S strains (see Example 6).
The present claims are obvious in view of the claims of the U.S. Patent No.12,290,556 and the Specification reciting the same Swine influenza A virus (IAV-S) strains as those recited in the present claims.
Claims 9-12 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/702,577.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to an RNA replicon particle comprising a nucleic acid construct comprising a first sequence, a second sequence, and a third nucleic acid sequence encoding a first, a second and a third neuraminidase (NA) antigen, respectively, of a Swine influenza A virus (IAV-S), wherein the first NA antigen is of the A/swine/Scotland/410440/1994-like H1huN2 (Scot/94) lineage, the second NA antigen is of the A/swine/Gent/1/1984-like H3N2 (Gent/84) lineage, and the third NA antigen is selected from the A(H1N1)pdm09 (pdm09) lineage or the Eurasian avian- like HlavN1 (EA) lineage .
The claims of the copending application are drawn to a method to protect a piglet against a pathogenic infection with swine influenza A virus (IAV-S) comprising passive immunization of the piglet through ingestion of colostrum or milk from a female pig actively immunized with a vaccine comprising an immunogen and a pharmaceutically acceptable carrier, wherein the immunogen is an alphavirus RNA replicon particle (aRP) vector encoding an antigen of an IAV-S. vector encode HA antigens of IAV-S strains of the lineages Scot/94 H1N2 and EurAsianAvian H1N1 and the second aRP vector encodes HA antigens of IAV-S strains of the lineages Gent1984 H3N2 and pandemic2009 H1N1.
The present RNA replicon particle comprising a nucleic encoding Swine influenza A virus (IAV-S) are obvious over the methods of using the claimed composition of the copending Application No. 18/702,577.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 9-12 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5, 7-14, 18-20, and 22-24 of copending Application No. 18/010,418.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to an RNA replicon particle comprising a nucleic acid construct comprising a first sequence, a second sequence, and a third nucleic acid sequence encoding a first, a second and a third neuraminidase (NA) antigen, respectively, of a Swine influenza A virus (IAV-S), wherein the first NA antigen is of the A/swine/Scotland/410440/1994-like H1huN2 (Scot/94) lineage, the second NA antigen is of the A/swine/Gent/1/1984-like H3N2 (Gent/84) lineage, and the third NA antigen is selected from the A(H1N1)pdm09 (pdm09) lineage or the Eurasian avian- like HlavN1 (EA) lineage.
The claims of the copending Application No. 18/010,418 are drawn to A nucleic acid construct comprising, in the order from 5' to 3' of its nucleic acid sequence:a first nucleic acid sequence encoding a first HA antigen of a Swine influenza A virus (IAV-S) of the A/swine/Scotland/410440/1994-like H1huN2 (Scot/94) lineage, and a second nucleic acid sequence encoding a second HA antigen of IAV-S of the Eurasian avian-like HlavN1 (EA) lineage and a nucleic acid construct comprising, in the order from 5' to 3' of its nucleic acid sequence:a first nucleic acid sequence encoding a first HA antigen of IAV-S of the A/swine/Gent/1/1984-like H3N2 (Gent/84) lineage, and a second nucleic acid sequence encoding a second HA antigen of IAV-S of the A(H1N1)pdm09 (pdm09) lineage.
The presently claimed RNA replicon particle comprising a nucleic encoding Swine influenza A virus (IAV-S) is obvious over the composition comprising the nucleic acid construct comprising, in the order from 5' to 3' of its nucleic acid sequence:a first nucleic acid sequence encoding a first HA antigen of a Swine influenza A virus (IAV-S) of the A/swine/Scotland/410440/1994-like H1huN2 (Scot/94) lineage of the copending Application No. 18/010,418.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 9-12 and 21 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19, 23-31 and 33-39 of copending Application No. 18/010,412.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to an RNA replicon particle comprising a nucleic acid construct comprising a first sequence, a second sequence, and a third nucleic acid sequence encoding a first, a second and a third neuraminidase (NA) antigen, respectively, of a Swine influenza A virus (IAV-S), wherein the first NA antigen is of the A/swine/Scotland/410440/1994-like H1huN2 (Scot/94) lineage, the second NA antigen is of the A/swine/Gent/1/1984-like H3N2 (Gent/84) lineage, and the third NA antigen is selected from the A(H1N1)pdm09 (pdm09) lineage or the Eurasian avian- like HlavN1 (EA) lineage .
The claims of the copending Application No. 18/010,412 are drawn to An immunogenic composition comprising a first and a second RNA replicon particle, wherein the first RNA replicon particle is an alphavirus RNA replicon particle and comprises a nucleic acid construct comprising a first nucleic acid sequence encoding a first hemagglutinin (HA) antigen of a Swine influenza A virus (IAV-S) and a second nucleic acid sequence encoding a second HA antigen of a IAV-S, wherein the first HA antigen is of the A/swine/Gent/1/1984-like H3N2 (Gent/84) lineage, and the second HA antigen is of the A(H1N1)pdm09 (pdm09) lineage, wherein the second RNA replicon particle is an alphavirus RNA replicon particle and comprises a nucleic acid construct comprising a third nucleic acid sequence encoding a third HA antigen of IAV-S and a fourth nucleic acid sequence encoding a fourth HA antigen of IAV-S, wherein the third HA antigen is of the A/swine/Scotland/410440/1994-like H1huN2 (Scot/94) lineage, and the fourth HA antigen is of the Eurasian avian-like HlavN1 (EA) lineage.
The presently claimed RNA replicon particle comprising a nucleic encoding Swine influenza A virus (IAV-S) is obvious over the composition comprising the nucleic acid construct comprising, in the order from 5' to 3' of its nucleic acid sequence:a first nucleic acid sequence encoding a first HA antigen of a Swine influenza A virus (IAV-S) of the A/swine/Scotland/410440/1994-like H1huN2 (Scot/94) lineage of the copending Application No. 18/010,412.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648