202
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
Applicants’ election without traverse of Group I, claims 3-5, 7-9, 15, 18, 20, 21, 29, 31, 32, 36 and 37 in the reply filed on September 3, 2026 is acknowledged. Claims 39, 57, 65 and 66 are withdrawn as being drawn to non-elected invention.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 29, 2024 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3-5, 7-9, 15, 18, 20, 29, 31, 32, 36 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Baumhof et al. (WO 2018/078053) in view of Charlston et al (US Patent 9,243,230).
Baumhof et al. teach immunogenic compositions comprising mRNA comprising an open reading frame encoding mRNA compound comprising an mRNA sequence encoding at least one antigenic viral peptide or protein, wherein the mRNA compound is encapsulated in or associated with said lipid nanoparticle identical with present Compound 2 in claim 36 (see claims 1-81, and Table on page 251, III-I, Examples 1-26).
Regarding present claim 4, Baumhof teaches wherein the precursor polyprotein comprises two or more capsid proteins and has a cleavage site specific for a viral protease between the two or more capsid proteins (see page 91).
Bauhof does not teach picornavirus 3C protease, or a capsid protein comprising viral P1 precursor protein.
Regarding present claims 5, 7-9, 15, 18, 20, 29, 31, 32, 36 and 37. Charleston et al. teaches constructs comprising picornavirus 3C protease, or a capsid protein comprising viral P1 precursor protein (see claims 1-11).
Regarding present claims 5, 7-9, 15, 18, 20, 29, 31, 32, 36 and 37. Charleston teaches that proteolytic processing of the precursor P1 into VP0 (VP2 plus VP4), VP3 and VP1 occur by means of the viral protease 3C or its precursor 3CD (see columns 8-10).
Regarding present claims 5, 7-9, 15, 18, 20, 29, 31, 32, 36 and 37. Charleston teaches wherein the HRV species is HRV-A16 or HRV-B14 or the 3CD is specific to an Enterovirus species, optionally wherein the Enterovirus species is genotype EV-D68 or EV-A71 (see column 10).
Charleston teaches wherein mRNA comprising the ORF encoding the viral P1 precursor polyprotein and the mRNA comprising the ORF encoding the picornavirus 3C protease (P1:3CD)
It would have been prima facie obvious to provide the composition of Baumhof comprising Charleston’s constructs of picornavirus 3C protease, or a capsid protein comprising viral P1 precursor protein because Charlson teaches picornavirus particles comprising the structural proteins of FMDV being non-replicative and non-infectious (see columns 6-7).
It would have been prima facie obvious to optimize Charleston’s mRNA comprising the ORF encoding the viral P1 precursor polyprotein and the mRNA comprising the ORF encoding the picornavirus 3C protease (P1:3CD) are present in one of the following ratios: 20:1, 10:1, 7:1, 5:1, 4:1, 3:1, 2:1, 1:1.
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Baumhof et al. (WO 2018/078053) in view of Charlston et al. (US Patent 9,243,230), and further in view of Liggett et al. (US Patent Application Publication US 2010/0233677) and Kalnin et al. (US Patent Application Publication US 2011/0091501).
Baumhof et al. and Charlston et al. teach the claimed invention as discussed above.
They do not teach present SEQ ID NO: 8 or SEQ ID NO: 11.
Liggett et al. teach a picornavirus 3C protease identical with present SEQ ID NO: 8 (see sequence alignment below).
Present SEQ ID NO: 8 and SEQ ID NO: 2153 in Liggett.
Query Match 99.9%; Score 3390; Length 2153;
Best Local Similarity 100.0%;
Matches 643; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 2 GPEEEFGMSIIKNNTCVVTTTNGKFTGLGIYDRILILPTHADPGSEIQVNGIHTKVLDSY 61
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1511 GPEEEFGMSIIKNNTCVVTTTNGKFTGLGIYDRILILPTHADPGSEIQVNGIHTKVLDSY 1570
Qy 62 DLFNKEGVKLEITVLKLDRNEKFRDIRKYIPESEDDYPECNLALVANQTEPTIIKVGDVV 121
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1571 DLFNKEGVKLEITVLKLDRNEKFRDIRKYIPESEDDYPECNLALVANQTEPTIIKVGDVV 1630
Qy 122 SYGNILLSGTQTARMLKYNYPTKSGYCGGVLYKIGQILGIHVGGNGRDGFSSMLLRSYFT 181
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1631 SYGNILLSGTQTARMLKYNYPTKSGYCGGVLYKIGQILGIHVGGNGRDGFSSMLLRSYFT 1690
Qy 182 EQQGQIQISKHVKDVGLPSIHTPTKTKLQPSVFYDIFPGSKEPAVLTEKDPRLKVDFDSA 241
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1691 EQQGQIQISKHVKDVGLPSIHTPTKTKLQPSVFYDIFPGSKEPAVLTEKDPRLKVDFDSA 1750
Qy 242 LFSKYKGNTECSLNEHIQVAVAHYSAQLATLDIDPQPIAMEDSVFGMDGLEALDLNTSAG 301
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1751 LFSKYKGNTECSLNEHIQVAVAHYSAQLATLDIDPQPIAMEDSVFGMDGLEALDLNTSAG 1810
Qy 302 YPYVTLGIKKKDLINNKTKDISKLKLALDKYDVDLPMITFLKDELRKKDKIAAGKTRVIE 361
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1811 YPYVTLGIKKKDLINNKTKDISKLKLALDKYDVDLPMITFLKDELRKKDKIAAGKTRVIE 1870
Qy 362 ASSINDTILFRTVYGNLFSKFHLNPGVVTGCAVGCDPETFWSKIPLMLDGDCIMAFDYTN 421
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1871 ASSINDTILFRTVYGNLFSKFHLNPGVVTGCAVGCDPETFWSKIPLMLDGDCIMAFDYTN 1930
Qy 422 YDGSIHPIWFKALGMVLDNLSFNPTLINRLCNSKHIFKSTYYEVEGGVPSGCSGTSIFNS 481
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1931 YDGSIHPIWFKALGMVLDNLSFNPTLINRLCNSKHIFKSTYYEVEGGVPSGCSGTSIFNS 1990
Qy 482 MINNIIIRTLVLDAYKHIDLDKLKIIAYGDDVIFSYKYKLDMEAIA KEGQKYGLTITPAD 541
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1991 MINNIIIRTLVLDAYKHIDLDKLKIIAYGDDVIFSYKYKLDMEAIA KEGQKYGLTITPAD 2050
Qy 542 KSSEFKELDYGNVTFLKRGFRQDDKYKFLIHPTFPVEEIYESIRWTKKPSQMQEHVLSLC 601
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2051 KSSEFKELDYGNVTFLKRGFRQDDKYKFLIHPTFPVEEIYESIRWTKKPSQMQEHVLSLC 2110
Qy 602 HLMWHNGPEIYKDFETKIRSVSAGRALYIPPYELLRHEWYEKF 644
|||||||||||||||||||||||||||||||||||||||||||
Db 2111 HLMWHNGPEIYKDFETKIRSVSAGRALYIPPYELLRHEWYEKF 2153
Kalnin teaches a picornavirus capsid protein identical with present SEQ ID NO: 11 (see sequence alignment below and SEQ ID NO: 30 in Kalnin).
Present SEQ ID NO: 11 and SEQ ID NO: 30 in Kalnin
Query Match 100.0%; Score 4524; Length 2179;
Best Local Similarity 100.0%;
Matches 856; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MGAQVSTQKSGSHENQNILTNGSNQTFTVINYYKDAASTSSAGQSLSMDPSKFTEPVKDL 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MGAQVSTQKSGSHENQNILTNGSNQTFTVINYYKDAASTSSAGQSLSMDPSKFTEPVKDL 60
Qy 61 MLKGAPALNSPNVEACGYSDRVQQITLGNSTITTQEAANAVVCYAEWPEYLPDVDASDVN 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 MLKGAPALNSPNVEACGYSDRVQQITLGNSTITTQEAANAVVCYAEWPEYLPDVDASDVN 120
Qy 121 KTSKPDTSVCRFYTLDSKTWTTGSKGWCWKLPDALKDMGVFGQNMFFHSLGRSGYTVHVQ 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 KTSKPDTSVCRFYTLDSKTWTTGSKGWCWKLPDALKDMGVFGQNMFFHSLGRSGYTVHVQ 180
Qy 181 CNATKFHSGCLLVVVIPEHQLASHEGGNVSVKYTFTHPGERGIDLSSANEVGGPVKDVIY 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 CNATKFHSGCLLVVVIPEHQLASHEGGNVSVKYTFTHPGERGIDLSSANEVGGPVKDVIY 240
Qy 241 NMNGTLLGNLLIFPHQFINLRTNNTATIVIPYINSVPIDSMTRHNNVSLMVIPIAPLTVP 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 NMNGTLLGNLLIFPHQFINLRTNNTATIVIPYINSVPIDSMTRHNNVSLMVIPIAPLTVP 300
Qy 301 TGATPSLPITVTIAPMCTEFSGIRSKSIVPQGLPTTTLPGSGQFLTTDDRQSPSALPNYE 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 TGATPSLPITVTIAPMCTEFSGIRSKSIVPQGLPTTTLPGSGQFLTTDDRQSPSALPNYE 360
Qy 361 PTPRIHIPGKVHNLLEIIQVDTLIPMNNTHTKDEVNSYLIPLNANRQNEQVFGTNLFIGD 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 PTPRIHIPGKVHNLLEIIQVDTLIPMNNTHTKDEVNSYLIPLNANRQNEQVFGTNLFIGD 420
Qy 421 GVFKTTLLGEIVQYYTHWSGSLRFSLMYTGPALSSAKLILAYTPPGARGPQDRREAMLGT 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 GVFKTTLLGEIVQYYTHWSGSLRFSLMYTGPALSSAKLILAYTPPGARGPQDRREAMLGT 480
Qy 481 HVVWDIGLQSTIVMTIPWTSGVQFRYTDPDTYTSAGFLSCWYQTSLILPPETTGQVYLLS 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 HVVWDIGLQSTIVMTIPWTSGVQFRYTDPDTYTSAGFLSCWYQTSLILPPETTGQVYLLS 540
Qy 541 FISACPDFKLRLMKDTQTISQTVALTEGLGDELEEVIVEKTKQTVASISSGPKHTQKVPI 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 FISACPDFKLRLMKDTQTISQTVALTEGLGDELEEVIVEKTKQTVASISSGPKHTQKVPI 600
Qy 601 LTANETGATMPVLPSDSIETRTTYMHFNGSETDVECFLGRAACVHVTEIQNKDATGIDNH 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 LTANETGATMPVLPSDSIETRTTYMHFNGSETDVECFLGRAACVHVTEIQNKDATGIDNH 660
Qy 661 REAKLFNDWKINLSSLVQLRKKLELFTYVRFDSEYTILATASQPDSANYSSNLVVQAMYV 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 REAKLFNDWKINLSSLVQLRKKLELFTYVRFDSEYTILATASQPDSANYSSNLVVQAMYV 720
Qy 721 PPGAPNPKEWDDYTWQSASNPSVFFKVGDTSRFSVPYVGLASAYNCFYDGYSHDDAETQY 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 PPGAPNPKEWDDYTWQSASNPSVFFKVGDTSRFSVPYVGLASAYNCFYDGYSHDDAETQY 780
Qy 781 GITVLNHMGSMAFRIVNEHDEHKTLVKIRVYHRAKHVEAWIPRAPRALPYTSIGRTNYPK 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 GITVLNHMGSMAFRIVNEHDEHKTLVKIRVYHRAKHVEAWIPRAPRALPYTSIGRTNYPK 840
Qy 841 NTEPVIKKRKGDIKSY 856
||||||||||||||||
Db 841 NTEPVIKKRKGDIKSY 856
It would have been prima facie obvious to provide the composition of Baumhof comprising Charleston’s constructs of picornavirus 3C protease, or a capsid protein comprising viral P1 precursor protein and further comprising present picornavirus protease of SEQ ID NO: 8 and picornavirus capsid polyprotein of SEQ ID NO: 11 because those proteins have been known in the prior art as evidenced by Liggett and Kalnin.
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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