DETAILED ACTION
Applicant’s amendment and remarks filed March 9, 2026 are acknowledged. Claims 22-27, 29, 30, 32 and new claim 33, and elected species gH, SEQ ID NO: 62, ferritin, SEQ ID NO: 14, and SEQ ID NO: 146, are under examination. Any prior objection or rejection that is not repeated or addressed below is either moot or withdrawn in view of Applicant’s amendment.
Claims Summary
Claims 22 and 23 directed to a nucleic acid molecule encoding a recombinant protein, wherein the protein comprises at least 100 contiguous amino acids from a monomeric subunit protein that is capable of self-assembling to form a nanoparticle, ferritin, joined to at least one immunogenic portion from EBV E protein, gH (elected species). Claim 33 is directed to an embodiment wherein the protein comprises ferritin. The monomeric subunit protein comprises an amino acid sequence that is at least about 80% identical to SEQ ID NO: 14 (claim 24). SEQ ID NO: 14 is 172 amino acids in length and represents an E. coli-ferritin/bullfrog-ferritin fusion protein (see Table 2 of the specification). The immunogenic portion comprises an amino acid sequence that is at least 80% identical to SEQ ID NO: 62 (claim 25 (elected species)), or comprises SEQ ID NO: 62 (claim 26). SEQ ID NO: 62 is 706 amino acids in length and represents EBV E gH protein (see Table 2 of the specification). In another embodiment, the immunogenic portion from EBV gH is a heterodimer or a heterotrimer (claim 27). The encoded recombinant protein comprises an amino acid sequence at least 80% identical to SEQ ID NO: 146 (claim 29 (elected species)). SEQ ID NO: 146 is 864 amino acids in length and represents a ferritin-gH fusion protein having SGGG linker (see Table 2 of the specification). Also claimed is a kit comprising the nucleic acid molecule (claim 30). Claim 32 is directed to a method of producing a composition that induces an immune response against EBV, comprising expressing in a cell the nucleic acid molecule.
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 22, 23, 25-27 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Carter et al. (US 7,097,841 B2, cited in the IDS filed 5/9/2024, “Carter”) in view of Johannsen et al. (PNAS, 2004, 101(46):16286-16291, “Johannsen”), and evidenced by UniProt Accession P03231 for GH_EBVB9 (1986). The claims are summarized above and correlated with the teachings of the prior art in bold font.
Carter discloses ferritin monomeric proteins, such as the L chain (which is at least 100 contiguous amino acids in length), that are fused with other proteins and self-assemble into particles (see Example 1, SEQ ID NO: 4, and col. 17, lines 50-59) (claims 22, 23 and 33). Although Carter does not characterize the particles as “nanoparticles”, the size of the assembled particles is expected to fall within the definition of “nanoparticle” given that the particles are produced in bacteria (see Example 1). The ferritin proteins are fused with viral envelope proteins for vaccination purposes (see col. 3, lines 32-35). They are produced from nucleic acid coding sequences that are transformed into cells (see Example 1) (claims 22, 23 and 32).
Carter does not specifically name EBV envelope protein gH as an antigen to be fused with ferritin, however, it would have been obvious to have selected any viral envelope for the purpose of making a vaccine, as taught by Carter (see col. 3, lines 32-35). Johannsen discloses an EBV envelope gH sequence that is 100% identical to Applicant’s SEQ ID NO: 62 (see Table 1, BXLF2, and UniProt Accession P03231) (claims 22, 23, 25 and 26). Given that EBV is a human pathogen of interest one would have been motivated to select Johannsen’s gH envelope polypeptide for Carter’s fusion protein vaccine with a reasonable expectation of success. Although Johannsen does not comment on whether gH forms heterodimers or heterotrimers, such is expected as an inherent property of gH, based on claim 27’s recitation of gH forming heterodimers or heterotrimers (claim 27). Therefore, the claimed embodiments would have been obvious to one of ordinary skill in the art before the effective filing date of the invention.
Applicant’s arguments filed March 9, 2026 have been carefully considered but fail to persuade. Applicant argues that Carter does not provide particular teachings as to how any arbitrary antigen could be joined with ferritin, given the challenges that would need to be addressed in doing so. Applicant points to col. 6, lines 1-26, where Carter discusses factors such as the size of the fusion construct and spacers for proper presentation to the immune system. Applicant also argues that Johannsen does not provide any teachings regarding the EBV E gH protein in terms of its being incorporated into a construct with ferritin with a reasonable expectation of success.
In response to these arguments, Carter’s teachings at col. 6, lines 1-26 provide guidance for the construction of fusion products comprising ferritin and other proteins and peptides, such as viral envelope proteins (see col. 3, lines 32-35). Given that Carter provides a solution to the problem of proper presentation based on size of the constructs (i.e., the use of spacers), one would have had a reasonable expectation of success. Johannsen is cited only to provide the gH protein and is not relied upon for teaching the whole invention as claimed. Carter provides the necessary teaching about making constructs of ferritin and antigens.
Applicant also argues that Johannsen does not comment on the formation of gH heterodimers or heterotrimers.
In response to this argument, the Office is not relying on Carter nor Johannsen to teach the formation of heterodimers/trimers. The Office is relying on the fact that gH naturally forms heterodimers/trimers based on claim 27, which states that gH forms heterodimers/trimers. Since Johannsen discloses the same gH protein used by Applicant (SEQ ID NO: 62), it is expected that the properties observed by Applicant about gH will also be present in that of Johannsen’s gH since they are the same protein. Therefore, the rejection is maintained for reasons of record.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Carter et al. (US 7,097,841 B2, cited in the IDS filed 5/9/2024, “Carter”) in view of Johannsen et al. (PNAS, 2004, 101(46):16286-16291, “Johannsen”), evidenced by UniProt Accession P03231 for GH_EBVB9 (1986) as applied to claim 22 above, and further in view of Daftarian et al. (WO 2010/115046 A2, cited in the IDS filed 5/9/2024, “Daftarian”). Claim 30 is directed to a kit comprising the nucleic acid.
The teachings of Carter and Johannsen are outlined above, neither of which disclose kits comprising the nucleic acid encoding the fusion proteins. However, it would have been obvious to have made kits comprising the nucleic acid with a reasonable expectation of success. One would have been motivated to produce kits for the purpose of marketing/selling a product, as in Daftarian, which discloses kits comprising nanoparticle-based vaccines (see abstract). Therefore, the claimed embodiment would have been obvious to one of ordinary skill in the art before the effective filing date of the invention. Applicant’s arguments filed March 6, 2026 have been addressed above.
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 22, 23, 27, 32 and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 44-47 of copending Application No. 19/073,654 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are directed to a species (a particular ferritin molecule) of the instantly claimed genus (any ferritin molecule). A species anticipates a genus. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In the remarks filed March 9, 2026, Applicant notes that the claim amendments render the claims nonobvious over the copending claims. In response, the instant claims and the copending claims remain directed to the same subject matter: nucleic acid encoding ferritin and EBV E gH. Therefore, the provisional rejection is maintained.
Claim 30 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 44-47 of copending Application No. 19/073,654 (reference application) as applied to claim 22 above, and further in view of Daftarian et al. (WO 2010/115046 A2, cited in the IDS filed 5/9/2024, “Daftarian”). Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 30 is directed to a kit comprising the nucleic acid.
The patented claims are not directed to a kit, however, it would have been obvious to have claimed a kit with a reasonable expectation of success. One would have been motivated to produce kits for the purpose of marketing/selling a product, as in Daftarian, which discloses kits comprising nanoparticle-based vaccines (see abstract). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Applicant’s arguments filed March 9, 2026 have been addressed above.
Conclusion
No claim is allowed.
Claims 24 and 29 are objected to for being dependent on a rejected claim would but otherwise be allowable if rewritten in independent form.
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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
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