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 the required species in the reply filed on 5/27/26 is acknowledged.
The elected species are a SARS-CoV-2 spike protein as the viral antigen and the APC-targeting ligand is ICAM1.
Claims 3 and 11 are withdrawn from consideration since they are drawn to non-elected species.
Claims 1, 2, 4-10 and 12-15 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/25/23, 6/11/25 and 3/31/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 6 is objected to because of the following informalities: the recitation of “SARS-COV2” is not consistent with the name recited in claim 5. It is suggested that the claim be amended to “SARS-CoV-2”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1, 4, 9 and 12 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of sources antigens is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the claimed viral antigen, bacterial antigen and tumor antigen are distinct antigen sources with unique functions and structures. In addition, the viruses of claim 4 represent several distinct viruses, each of which have distinct tropisms, replication pathways and structures.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Leonard et al. (WO/19/199941) and Seow et al. (US PGPub 20130053426).
.
The claimed invention is drawn to a vaccine composition comprising a first polynucleotide encoding or a viral antigen and a second polynucleotide encoding a fusion protein comprising an a ICAM1 and an exosomal or lysosomal transmembrane protein.
The first and second polynucleotide are present in a single plasmid and the claimed invention requires administering the vaccine composition to a subject via transfecting skin cells of the subject.
The claimed invention also requires a vaccine composition comprising an extracellular vesicle (EV) comprising a viral antigen and a plasmid or oligonucleotide encoding a viral antigen, wherein the EV is decorated on the surface with ICAM1.
Leonard et al. teach extracellular vesicles (EVs) with ICAM-1 on surface-(paragraphs 17 and 137; delivery of therapeutic biomolecules (paragraphs 43, 135 and figure 3) cargo-RNA, protein or RNA-protein complexes (paragraph 58), EV comprising novel proteins, polypeptides, peptides (see paragraph 60), delivery of polynucleotides, vectors, DNA plasmids (see paragraph 87), use of TM to link/present heterologous protein on surface (see paragraph 90, 94, claims 1, 5, 6). Leonard et al. also teach the polynucleotides that encode the ICAM-1 transmembrane fusion protein in the transfection of HEK cells in order to produce extracellular vesicles that possess an EV with ICAM-1 on the surface. [see paragraph 137]
However, Leonard et al. do not teach a polynucleotide encoding or comprising viral antigen or an EV with a viral antigen and a plasmid comprising the polynucleotide sequence or the expression of the first and second polynucleotide on a single plasmid or the administration of the vaccine composition to a subject during a vaccination method.
Seow et al. teach nucleic acid can also be used for example in immunization (which meets the claim requirements of vaccination since an obvious variant of the active steps are taught) to express one or more antigens against which it is desired to produce an immune response. Thus, the nucleic acid to be loaded into the exosome can encode one or more antigens against which is desired to produce an immune response, including but not limited to antigens from viral pathogens. [see paragraph 34] Seow et al. also teach that exosomes can possess a targeting moiety on the surface of the exosome by using an exosomal transmembrane protein, wherein the targeting moiety is ICAM-1. [see paragraph 46] Seow et al. also teach that the exosomes can be use to delivery nucleic acids, such as plasmids for the purpose of inducing an immune response. [see paragraph 6 and claims 1, 3 and 6]
It would have been obvious to one of ordinary skill in the art to modify the compositions and methods taught by Leonard et al. in order to provide a polynucleotide encoding or comprising viral antigen with a polynucleotide encoding a ICAM-1 fused to a transmembrane protein of an exosome or an EV with a viral antigen and a plasmid comprising the polynucleotide sequence or the presence of the first and second polynucleotide on a single plasmid or the administration of the vaccine composition to a subject during a vaccination method. One would have been motivated to do so, given the suggestion by Leonard et al. that the EVs with ICAM-1 on their surface can be generation to facility targeting of therapeutic proteins, nucleic acid sequences or a combination and the use of a nucleic acid sequence of an ICAM-1 with a transmembrane protein used to generation EVs possesses the ICAM-1 on the surface. There would have been a reasonable expectation of success, given the knowledge that viral proteins can be expressed by nucleic acid sequences, including in plasmids, which can be in an exosome, as taught by Seow et al. Furthermore, with Seow et al. teach that exosomes being loaded with genetic material, which are to encode immunogens and that the exosomes also possess a targeting moiety expressed on its surface, one of ordinary skill in the art would be motivated to include a plasmid that contains a nucleic acid sequence encoding a viral antigen and a nucleic acid sequence encoding an ICAM-1 fused to exosome transmembrane domain. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim(s) 4-6 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Leonard et al. and Seow et al. as applied to claims 1, 2 and 7-10 above, and further in view of Gould et al. (US PGPub 2023/0142621).
The claimed invention also requires that the vaccine compositions comprises a polynucleotide encoding a viral antigen and a viral antigen itself, wherein the viral antigen is a coronavirus antigen, such as the spike protein from SARS-CoV-2. The claims also require that a subject be vaccinated with this SARS-CoV-2 vaccine composition.
The teachings of Leonard et al. and Seow et al. are summarized above, however, they do not teach that the viral antigen is that of a spike protein from SARS-CoV-2.
Gould et al. teach the generation of exosomes (extracellular vesicles-EVs) that possess nucleic acid sequences encoding the spike protein from a SARS-CoV-2 virus and a method of immunizing against a subject by using the EVs. [see abstract and paragraphs 43 and 62-66]
It would have been obvious to one of ordinary skill in the art to further modify the compositions and methods taught by Leonard et al. and Seow et al. in order to employ a polynucleotide sequence encoding a SARS-CoV-2 spike protein and/or the protein itself as part of the EV composition or the nucleic acid vaccine composition. One would have been motivated to do so, given the suggestion by Leonard et al. that the EVs with ICAM-1 on their surface can be generation to facility targeting of therapeutic proteins, nucleic acid sequences or a combination and the use of a nucleic acid sequence of an ICAM-1 with a transmembrane protein used to generation EVs possesses the ICAM-1 on the surface. There would have been a reasonable expectation of success, given the knowledge that viral proteins can be expressed by nucleic acid sequences, including in plasmids, which can be in an exosome, as taught by Seow et al. Furthermore, with Seow et al. teach that exosomes being loaded with genetic material, which are to encode immunogens and that the exosomes also possess a targeting moiety expressed on its surface, one of ordinary skill in the art would be motivated to include a plasmid that contains a nucleic acid sequence encoding a viral antigen and a nucleic acid sequence encoding an ICAM-1 fused to exosome transmembrane domain. There would have been additional reasonable expectations of success, given the knowledge that SARS-CoV-2 spike proteins can be expressed by nucleic acid sequences, including in plasmids, which can be in an exosome, as taught by Gould et al. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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