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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 23, 2026 has been considered by the examiner.
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 128, 151, 152, 154, 155, and 157 remain rejected under 35 U.S.C. 103 as being unpatentable over Remarque et al. (WO2018/073340), SEQ 33 alignment with Geneseq db access no BDK47462 in WO2016201127 by Strugnell et al., SEQ 33 alignment with Geneseq db access no BEG65754 in WO2017137753 by Digard, SEQ 53 alignment with Geneseq db access no AEK61609 in WO2006098901 by Yang et al., and SEQ 53 alignment with Geneseq db access no AUY92043 in WO2008157419 by Golding et al. All references of record.
In reply to the rejection of record, applicant cites the following web addresses:
https://www.ncbi.nlm.nih.gov/protein/BDK47462 https://www.ncbi.nlm.nih.gov/protein/AEK61609 https://www.ncbi.nlm.nih.gov/protein/AUY92043
and submits that the Geneseq db access nos. BDK47462, BEG65754, AEK61609, or AUY92043 do not correspond to sequences of influenza virus hemagglutinin antigens. Applicant asserts that Geneseq db access no. BDK47462 corresponds to a PTS sorbitol transporter subunit IIB; Geneseq db access no. BEG65754 does not correspond to a Geneseq db entry; Geneseq db access no. AEK61609 corresponds to a hypothetical protein CFU_17772, and Geneseq db access no. AUY92043 corresponds to a flagellar assembly peptidoglycan hydrolase FlgJ.
Applicant’s arguments have been fully considered and are unpersuasive. The information provided within https://www.ncbi.nlm.nih.gov/protein/, accessed by applicant, does not include the Geneseq database. For applicant’s convenience, the website that appears at the https://www.ncbi.nlm.nih.gov/protein/ address is pasted below:
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In the black box, it states:
The Protein database is a collection of sequences from several sources, including translations from annotated coding regions in GenBank, RefSeq and TPA, as well as records from SwissProt, PIR, PRF, and PDB.
The Geneseq database, possessing the sequence alignments of instant SEQ ID NOs: 33 and 53 with the prior art, provided with the November 25, 2025 Office action, is not listed as a database source by the NCBI website. Nor is the Geneseq database accessible from NCBI. Public access to the Geneseq database is found at: Derwent GENESEQ Biological Sequence Database | Clarivate (image provided below for assistance):
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Geneseq database access no: BDK47462 in WO2016201127 by Strugnell et al. shares 100% sequence identity to SEQ ID NO: 33, see the alignment previously provided;
Geneseq database access no: BEG65754 in WO2017137753 by Digard shares 99.9% (rounds to 100%) sequence identity to SEQ ID NO: 33, see the alignment previously provided;
Geneseq database access no: AEK61609 in WO2006098901 by Yang et al. shares 99.6% (rounds to 100%) sequence identity to SEQ ID NO: 53, see the alignment previously provided; and Geneseq database access no: AUY92043 in WO2008157419 by Golding et al. shares 99.4% (rounds to 99%) sequence identity to SEQ ID NO: 53, see the alignment previously provided.
Applicant argues that there are no reasons provided any reason as to why the skilled artisan would combine the teachings of Remarque, which does not teach the claimed sequence identities, with the sequences of Strugnell, Digard, Yang, or Golding. Nor has the Office provided a reason that a skilled artisan would select these particular sequences.
Applicant’s arguments have been fully considered, but are found unpersuasive. It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have included the sequences of Geneseq database access no: BDK47462; Geneseq database access no: BEG65754; Geneseq database access no: AEK61609; and Geneseq database access no: AUY92043 in the vaccine composition of Remarque et al. because each of the sequences are used in influenza vaccine compositions to treat and/or prevent infection, see the description in each alignment provided. Demonstrated vaccine efficacy of the specific Geneseq database sequences would have inspired the ordinary artisan to include them in the multivalent vaccine of Remarque.
Applicant points to page 64, paragraph 2 of Remarque, noting that "broadening could not yet be measured" for a pentavalent vaccine composition. Applicant opines that combining strains to produce a polyvalent vaccine composition does not necessarily result in a targeted broadening effect.
Applicant’s arguments have been fully considered, but are found unpersuasive. The broadening effect Remarque is remarking on concerns the lack of sensitivity to detect A/California/7/2009 responses in mouse serum, though “previously observed with mini HA stem antigen constructs (lmpagliazzo et al. (2015), Science 349(6254), 101-106)”. This discussion does not contradict or discredit the rest of the data provided by Remarque, demonstrating broadening protection to influenza viruses against multivalent H1 HAs and H3 HAs that are not included in the vaccine on page 6, line 32 to line 7, line 7; page 37, lines 23-25; lines 11-34 on page 56; and Tables 1-4, bridging pages 60-62 and 64, and claims 18, 20, 22, 24, 39, and 41.
Claims 147, 149, 150, and 153 remain rejected under 35 U.S.C. 103 as being unpatentable over Remarque et al., Geneseq db access no BDK47462, Geneseq db access no BEG65754, Geneseq db access no AEK61609, and Geneseq db access no AUY92043, as applied to claims 128, 151, 152, 154, 155, and 157 above, and further in view of Alexander et al. (USPgPub 2008/0032921). All references of record.
Applicant argues that Alexander does not cure the deficiencies of Remarque or any of the aforementioned GenBank entries.
Applicant’s arguments have been fully considered, but are found unpersuasive because there are no deficiencies for Alexander to cure.
Claims 148 and 156 remain rejected under 35 U.S.C. 103 as being unpatentable over Remarque et al., Geneseq db access no BDK47462, Geneseq db access no BEG65754, Geneseq db access no AEK61609, Geneseq db access no AUY92043, and Alexander et al. as applied to claims 128, 147, 149-155, and 157 above, and further in view of Palese et al. (USPgPub 2018/0008696). All references of record.
Applicant argues that Palese does not cure the deficiencies of Remarque or any of the aforementioned GenBank entries.
Applicant’s arguments have been fully considered, but are found unpersuasive because there are no deficiencies for Palese to cure.
Claim 158 is rejected under 35 U.S.C. 103 as being unpatentable over Remarque et al., Geneseq db access no BDK47462, Geneseq db access no BEG65754, Geneseq db access no AEK61609, and Geneseq db access no AUY92043, as applied to claims 128, 151, 152, 154, 155, and 157 above, and further in view of Winter et al. (Journal of Clinical Virology. 2013; 57: 279– 281).
None of the references teach A/Wisconsin/28/2011, as recited in instant claim 158.
However, Winter et al. do, see Table 2.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have included an HA antigen from A/Wisconsin/28/2011, as taught by Winter et al., as one of the HA antigens in the vaccine composition of Remarque et al., Geneseq db access no BDK47462, Geneseq db access no BEG65754, Geneseq db access no AEK61609, Geneseq db access no AUY92043, to include A/Wisconsin/28/2011, as a prior pathogenic, circulating strain. One of ordinary skill in the art prior to the effective filing date would have had a reasonable expectation of success for including an HA antigen from A/Wisconsin/28/2011 as taught by Winter et al., as one of the HA antigens in the vaccine composition of Remarque et al., Geneseq db access no BDK47462, Geneseq db access no BEG65754, Geneseq db access no AEK61609, Geneseq db access no AUY92043, and because Remarque et al. teach incorporating previous and current circulating influenza virus strains, see page 3, lines 34-36, page 6, line 32 to page 7, line 7, page 13, lines 11-37, and page 39, lines 1-8.
Claim 159 is rejected under 35 U.S.C. 103 as being unpatentable over Remarque et al., Geneseq db access no BDK47462, Geneseq db access no BEG65754, Geneseq db access no AEK61609, and Geneseq db access no AUY92043, as applied to claims 128, 151, 152, 154, 155, and 157 above, and further in view of Levine et al. (Journal of Infectious Diseases. Published online 4 Feb 2019; 219 (12): 1904-12).
None of the references teach A/Indiana/11/2018, as recited in instant claim 159.
However, Levine et al. do, see Figure 2 within the 3C.2a1 clade bracket.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have included an HA antigen from A/Indiana/11/2018, as taught by Levine et al., as one of the HA antigens in the vaccine composition of Remarque et al., Geneseq db access no BDK47462, Geneseq db access no BEG65754, Geneseq db access no AEK61609, Geneseq db access no AUY92043, to include A/Indiana/11/2018, as a prior pathogenic, circulating strain. One of ordinary skill in the art prior to the effective filing date would have had a reasonable expectation of success for including an HA antigen from A/Indiana/11/2018 as taught by Levine et al., as one of the HA antigens in the vaccine composition of Remarque et al., Geneseq db access no BDK47462, Geneseq db access no BEG65754, Geneseq db access no AEK61609, Geneseq db access no AUY92043, and because Remarque et al. teach incorporating previous and current circulating influenza virus strains, see page 3, lines 34-36, page 6, line 32 to page 7, line 7, page 13, lines 11-37, and page 39, lines 1-8.
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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