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 .
Applicants’ preliminary amendment filed on April 18, 2024, is acknowledged. Claims 1-14 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 13, 2025 and June 1, 2026 have been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-6 and 9-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The present claims 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.
The full scope of the present invention is not enabled for the following reasons. While the present specification provides sufficient enablement for the method of protecting a piglet against swine influenza A virus (IAV-S) infection, the method comprising passive immunization of the piglet through ingestion of colostrum or milk from a female pig, actively immunized with a vaccine comprising the EUSIV-K and EUSIV-T8 VEE vectors each encoding 2 HA antigen and a pharmaceutically acceptable carrier, the specification does not provide sufficient enablement for the method wherein the immunogen is any alphavirus RNA replicon particle (aRP) vector encoding an IAV-S antigen.
Examples 2-4 of the present specification demonstrate that the induction of a protective lactogenic immune response cannot be achieved by any replicon particle vector encoding any antigen since the VEE vector encoding the PEDV spike glycoprotein gene failed to protect the piglets against PEDV-induced mortality. In view of this, the present application does not provide sufficient enabling disclosure for the entire scope of the claimed invention.
Specification [0017] The current invention results from an unexpected finding that, despite the fact that experiments show that a vaccine based on an αRP vector failed to afford passive protection in piglets against a pathogenic infection with a swine pathogen that, like IAV-S, also replicates locally in mucosal tissue, PEDV (Example 3), in contrast, the active vaccination of sows with an αRP IAV-S vector based vaccine did provide passive protection in the sows' piglets (Example 2). Paragraph [0082] αRP vectors EUSIV-K and RP EUSIV-T8 were used to determine the immunogenicity and efficacy of a multivalent IAV-S vaccine comprising the two-dual-HA RPs.
Example 3. [0110] The vaccine induced a moderate level (between 80-160) of serum PED neutralization (PED SN) titer post 3 vaccinations (FIG. 4). FFN (fluorescent focus neutralization) assay is used to determine PEDV serum neutralization titer. Piglets born from vaccinated sows had PED-maternally derived antibodies (80-640) against the PED challenge strain at the timepoint before challenge (FIG. 5).
Examples 2 and 4. [0112] Completely corresponding to example 2, this experiment evaluated the lactogenic immune protection of piglets against influenza A virus induced by multi-gene IAV-S HA RNA particles mixed with 50% (v/v) Xsolve adjuvant by vaccinating multiparity sows and demonstrating the passive protection, but against an alternative IAV-S challenge strain, viz. A/swine/Belgium/113/2013 (H3N2) at 6 WOA.
As discussed above the full scope of the present invention is not enabled in Applicant’s specification.
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)(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.
Claims 13 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mogler et al. (WO 2019/121513 in IDS on 6/13/2025).
Mogler et al. discloses a method for making an IAV-S vaccine comprising combining an alphavirus RNA replicon vector encoding an antigen of an IAV-S with a pharmaceutically acceptable carrier (see Example 1 and claims 1-26).
Thus, by this disclosure Mogler et al. anticipate the present claims.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sanbulete et al (Vaccines, January 2015, p. 22-73 ) in view of Mogler et al. (WO 2019/121513 in IDS on 6/13/2025).
Regarding claims 1-6 and 9-12. Sanbulete et al., teaches the induction of lactogenic/passive immune protection of piglets by maternal antibodies against IAV-S (see page 34, point 4). Sanbulete et al., does not mention that the maternal antibodies have been induced by vaccination of the female pig with an alphavirus replicon particle vector encoding an IAV-S antigen.
Mogler et al. teaches an immunogenic composition comprising a first alphavirus RNA replicon particle that encodes a first neuraminidase (NA) or an antigenic fragment thereof and a second alphavirus RNA replicon particle that encodes a second NA or an antigenic fragment thereof, with the proviso that the immunogenic composition neither comprises a Swine influenza A virus (IAV-S) hemagglutinin (HA) or an antigenic fragment thereof, nor a nucleotide sequence that encodes the IAV-S hemagglutinin (HA) or the antigenic fragment thereof and methods for immunizing a porcine against a swine influenza A virus comprising administering the vaccine (see claims 1-26).
Regarding claims 7, 8, 10 and 11. Mogler teaches ccording to characterized in that the vaccine comprises a first aRP vector encoding HA antigens of IAV-S strains of two of the lineages selected from the group consisting of Scot/94 H1N2, EurAsianAvian H1N1, Gent1984 H3N2 and pandemic2009 H1N1 and a second aRP vector encoding HA antigen of IAV-S strains of the two other lineages of that group and E.Coli and Clostridium perfingens antigens (see Examples 1-6, claims 15-21 and Table 7).
It would have been prima facie obvious to provide the method of Sanbulete combined with the method of Mogler and to provide passive immunization to piglets 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 and the method according to characterized in that the first aRP 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,
Passive immunization through colostrum is well known to provide protection against pathogenic viruses in animals and humans, as evidenced by Sanbulete et al.
Thus, the present invention would have been prima facie obvious at the time the invention was made.
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 1-14 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 a method to protect a piglet against a pathogenic infection with swine influenza A virus (IAV-S) [[by]] comprising passive immunization of the piglet through ingestion of colostrum or milk from a female pig actively immunized with [[the]] 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.
The claims of the US Patent 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. A method of immunizing a porcine against a swine influenza A virus comprising administering to the porcine an immunologically effective amount of the vaccine of claim 16.
The present claims are obvious over the claims of the US Patent 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. A method of immunizing a porcine against a swine influenza A virus comprising administering to the porcine an immunologically effective amount of the vaccine.
Contact Information
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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