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 .
Applicant’s amendments to the instant specification overcomes the objection to the disclosure. An updated search in the prior art prompts new grounds of rejection necessitated by applicant’s amendments to the claims.
Information Disclosure Statement
The information disclosure statements (IDS’s) submitted on 11/4/2025 and 3/6/2026 have been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 and subsequent claims, 7-28, depend on cancelled claim 5 and are therefore incomplete. See MPEP § 608.01(n) V. No meaning can be gleaned. Claims 6-28 are withdrawn from consideration.
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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Lakotos et al. (Human Vaccines and Immunotherapeutcs. 2020; 16 (8): 1957-1968), as evidenced by Wen et al. (Vaccine. 2014; 32: 4420-4427), and further in view of Günaydın et al. (Scientific reports. 2016 Jul 21; 6 (1):30171, of record), and George et al. (USPgPub 2005/0031628, of record).
Lakotos et al. teach a trivalent immunogenic composition comprising the P2 epitope of tetanus toxoid to recombinant ΔVP8* subunit proteins derived from rotavirus strains DS-1 (P[4]), 1076 (P[6]), and Wa (P[8]), see the abstract, Introduction, and “Rotavirus antigen”. The P2 epitope of Lakotos et al. is a 14-residue amino acid universal CD4+ T cell epitope conjugated to the N-terminus of the ΔVP8* subunit, as evidenced by the paragraph above the “Materials and methods” on page 4421 and section 2.2 of Wen et al., pointed to by Lakotos et al. as reference (21) in the paragraph bridging pages 1957-1958. Therefore, the teachings of Lakotos et al., as evidenced by Wen et al., teach the instant polypeptide (i) and the at least one additional immunogenic substance (ii) of claim 1. Figures 6-8 of Lakotos et al. demonstrate immunogenicity against homologous and heterologous rotavirus antigens was enhanced by the fusion of P2-VP8*, as required by the “wherein” clause of instant claim 1.
Lakotos et al., as evidenced by Wen et al., do not teach conjugating the truncated rotavirus spike protein, P2-VP8* fusion to an immunoglobulin Fc fragment at the c-terminus of the ΔVP8* by a linker, as required in claims 1-3.
Günaydın et al. teach fusion of an Fc domain to an anti-rotavirus protein 1 (ARP1), see Figure 1.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have fused the Fc domain of Günaydın et al. to the c-terminus of the P2-ΔVP8* of Lakotos et al., as evidenced by Wen et al. because Günaydın et al. teach the Fc part of immunoglobulins are engaged in Fc-mediated neutralization of rotavirus, see the second and fourth full paragraphs on page 7, and the construct confers protection against rotavirus induced diarrhea in infant mouse model of rotavirus induced diarrhea, see Figure 5. One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have fused the Fc domain of Günaydın et al. to the c-terminus of the P2-ΔVP8* of Lakotos et al., as evidenced by Wen et al., because George et al. teach fastening of Fc to an antigen enhances target binding and presentation to antigen-presenting cells (APCs) in paragraphs [0014-0017]. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have fused the Fc domain of Günaydın et al. to the c-terminus of the ΔVP8* of Lakotos et al., as evidenced by Wen et al., because George et al. teach Fc is linked at the c-terminus of a viral antigen by a linker in Figures 1A and 1B and paragraphs [0055 and 0100] and includes rotavirus antigens in paragraphs [0072-0073].
In reply to the rejection of record, applicant argues that there is no motivation to conjugate the Fc fragment to the C-terminus of ΔVP8*, as required, because there is no direction to combine the disparate elements of the references to arrive at the construct of instant claim 1. Applicant points out that paraphs [0073-0074] of George et al. list about 150 antigens, but does not fuse the Fc domain to a rotavirus V8 protein.
Applicant’s arguments have been fully considered, but are found unpersuasive. Günaydın et al. teach fusion of Fc to an anti-rotavirus protein 1 (ARP1), see Figure 1, which confers protection against rotavirus induced diarrhea in infant mouse model of rotavirus induced diarrhea, depicted in Figure 5. Both Günaydın et al. and Lakotos et al., as evidenced by Wen et al., are focused on the same endeavor, i.e., a rotavirus vaccine. MPEP § 2144.06 recites the conclusions of In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA), “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose...[T]he idea of combining them flows logically from their having been individually taught in the prior art.”
One of ordinary skill in the art prior to the instant effective filing date would have had a more than reasonable expectation of success to have fused the Fc domain of Günaydın et al. to the c-terminus of the P2-ΔVP8* of Lakotos et al., as evidenced by Wen et al., because Günaydın et al. fuse an Fc domain to an anti-rotavirus protein 1 (ARP1) to induce protection against rotavirus in Figures 1 and 5 and George et al. teach Fc is linked at the c-terminus of a viral antigen by a linker in Figures 1A and 1B and paragraphs [0055 and 0100] and includes rotavirus antigens in paragraphs [0072-0073]. Therefore, fusing an Fc domain to enhance immunogenicity of an antigenic moiety it is conjugated to is conventional in the prior art, aa evidenced by George et al. (2005) and Günaydın et al. (2016).
Applicant points to paragraph [0481+] of the instant published disclosure, showing that the instant V8-Fc fusion from genotype P[13] induced broader and stronger neutralizing antibody responses in swine better than either antigen alone. Applicant asserts that an ordinary artisan would not have had a reasonable expectation of success for inducing an immune response against at least two rotavirus genotypes without specific guidance and the benefit of applicant's teachings.
Applicant’ arguments and a review of the data presented in the instant application has been fully considered, but are found unpersuasive. Figures 6-8 of Lakotos et al. demonstrate immunogenicity against homologous and heterologous rotavirus antigens was enhanced by the fusion of P2-ΔVP8*, as required. Günaydın et al. depict Fc-mediated neutralization of rotavirus in Figure 5, discussed in the second paragraph on page 7. Therefore, no unexpected results are instantly demonstrated beyond the reasonable expectation of the skilled artisan fusing P2-ΔVP8* of Lakotos et al., as evidenced by Wen et al., to the Fc of Günaydın et al. and George et al.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lakotos et al., as evidenced by Wen et al., and Günaydın et al. and George et al. as applied to claims 1-3 above, and further in view of Sun et al. (Journal of Virology. 2018; 92 (14): e00538-18).
See the teachings of Lakotos et al., as evidenced by Wen et al., and Günaydın et al. and George et al. above. None of the references mention porcine rotavirus A, as required.
Sun et al. examine glycan binding specificities of human and porcine P[6]/P[19] RV VP8*s (porcine rotavirus A types (RVA)) and conserved areas.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have selected a porcine/ human rotavirus type A of Sun as the ΔVP8* portion of
Lakotos et al., as evidenced by Wen et al., Günaydın et al., and George et al. because Sun et al. teach RVA are a major cause of acute gastroenteritis in humans and animals, see the paragraph bridging pages 1-2. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have selected a porcine/ human rotavirus type A of Sun et al. as the ΔVP8* portion of Lakotos et al., as evidenced by Wen et al., Günaydın et al., and George et al. because Sun et al. depict similarities between human and porcine VP8* in Figures 1-3, 6, and 7.
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 1-3 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12 and 15 of copending Application No. 17/493,269 (reference application, allowed March 13, 2026) in view of Lakotos et al. (Human Vaccines and Immunotherapeutcs. 2020; 16 (8): 1957-1968), as evidenced by Wen et al. (Vaccine. 2014; 32: 4420-4427), George et al. (USPgPub 2005/0031628, of record), and Chen et al. (Advanced Drug Delivery. 2013; 65: 1357-1369, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 12 of '269 teaches a polypeptide comprising an immunogenic fragment of a rotavirus V8 and an Fc fragment. The polynucleotide encoding the polypeptide, recited in claim 15 of '269, is also not patentably distinct from the instant claims because the polynucleotide of '269 encodes the instant polypeptide. The claims of '269 do not mention N-terminally extending the lectin-like domain of VP8 with 1-20 amino acid residues.
Lakotos et al. teach a trivalent immunogenic composition comprising the P2 epitope of tetanus toxoid to recombinant ΔVP8* subunit proteins derived from rotavirus strains DS-1 (P[4]), 1076 (P[6]), and Wa (P[8]), see the abstract, Introduction, and “Rotavirus antigen”. The P2 epitope of Lakotos et al. is a 14-residue amino acid universal CD4+ T cell epitope conjugated to the N-terminus of the ΔVP8* subunit, as evidenced by the paragraph above the “Materials and methods” on page 4421 and section 2.2 of Wen et al., pointed to by Lakotos et al. as reference (21) in the paragraph bridging pages 1957-1958. These teachings, combined with claims 12 and 15 of ‘269 satisfy the instant polypeptide (i) and the at least one additional immunogenic substance (ii) of claim 1.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have extended the VP8-Fc of ‘296 with 14 amino acid residues of P2 because it is a universal CD4+ T cell epitope, demonstrating immunogenicity against homologous and heterologous rotavirus antigens was enhanced by the fusion of P2-VP8*, as required by the “wherein” clause of instant claim 1. See Figures 6-8 of Lakotos et al.
The claims of ‘269 do not mention that the Fc portion is linked to the c-terminus of the rotavirus antigen
However, George et al. depicts Fc linked at the c-terminus of a viral antigen by a linker in Figures 1A and 1B and paragraphs [0055 and 0100] and includes rotavirus antigens in paragraphs [0072-0073]. Therefore, this configuration is established in the art as a conventional assembly of Fc-viral antigen construction.
The claims of ‘269 do not mention attaching the two portions: Fc-V8 with a linker.
George et al. teaches placement of a linker between Fc and at least one viral antigen in paragraphs [0071, 0076, and 0147] and claims 12-15.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have incorporated a linker between the Fc-V8 components of ‘269 and Lakotos, as evidenced by Wen et al., because Chen et al. teach Fc domain fusions to polypeptides extend plasma half-lives, achieve enhanced therapeutic effects, and increase stability, see Figure 1, the Introduction, and Table 3. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have incorporated a linker between the Fc-V8 components of ‘269 and Lakotos, as evidenced by Wen et al. because George et al. teaches placement of a linker between Fc and at least one viral antigen in paragraphs [0071, 0076, and 0147] and claims 12-15.
Applicant argues that instant amended claim 1 renders the claimed subject matter patentably distinct from the subject matter of ‘269.
In reply, the recited limitations of claims 12 and 15, combined with the teachings of Lakotos, as evidenced by Wen et al., George et al., and Chen et al. render the instant claims prima facie obvious.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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/Shanon A. Foley/ Primary Examiner, Art Unit 1671
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