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 .
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 .
Applicants’ amendment filed on August 3, 2026 is acknowledged. Claims 3-5, 7, 11, 13, and 16-20 were canceled. Claims 1, 2, 6, 8-10, 14, 21-23 and 27-28 were amended. Claims 1, 2, 6, 8-10, 12, 14-15, and 21-28 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on August 14, 2026 has been considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Rejection of Claims 1, 2, 14, 15, under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is maintained. The claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 2, are A method for inducing an immune response to GI.1, GII.2, GII.4, GII.7 and GII.12 noroviruses in an animal, comprising administering to the animal an effective amount of a GII.4 norovirus virus-like particle, wherein the GII.4 norovirus virus-like particle comprises or is composed of an amino acid sequence as shown as SEO ID NO: 4.
Claims 14 and 15 are drawn to A method for the prophylaxis and/or treatment of a norovirus infection, comprising adminstering to a subject in need thereof a therapeutically effective amount of a GII.4 norovirus virus-like particle, wherein the GII.4 norovirus virus-like particle comprises or is composed of an amino acid sequence as shown as SEQ ID NO: 4.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite naturally occurring GII. 2, GII. 4, GII. 6 and GII. 17 norovirus virus-like particles, comprising an amino acid sequence of SEQ ID NO: 2, 4, 5 and 8, respectively and read on a naturally occurring norovirus infection.
Rauch et al., (US Patent 11,141,474) teaches naturally occurring GII. 2, GII. 4, GII. 6 and GII. 17 norovirus virus-like particles, comprising an amino acid sequence of SEQ ID NO: 2, 4, 5 and 8, respectively. Pei teaches a tetravalent norovirus vaccine comprising GII.1, GII.3, GII.4, and GII.17 (see Abstract). Pei teaches that a tetravalent norovirus vaccine comprising GII.1, GII.3, GII.4, and GII.17 is a promising candidate vaccine with broad spectrum protection against norovirus (see last paragraph in English).
Applicant is suggested to amend the claims to recite additional elements such as adjuvants or other compositions administered in the methods of treating norovirus.
Claim Rejections - 35 USC § 112
Rejection of Claims 9, 16 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 is withdrawn in view of Applicant’s amendment.
Rejection of Claim 9 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of Applicant’s amendment.
Rejection of claims 1-28 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of Applicant’s amendment.
Claim Rejections - 35 USC § 102
Rejection of Claims 1-24 and 26-28 under 35 U.S.C. 102(a)(2) as being anticipated by Rauch et al., (US Patent 11,141,474) is withdrawn in view of Applicant’s amendment.
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.
Rejection of Claims 6-9, 16-20 under 35 U.S.C. 103 as being unpatentable over Rauch et al., (US Patent 11,141,474) is modified in view of Applicant’s IDS.
Claims 1, 2, 6, 8-10, 12, 14-15, and 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Rauch et al., (US Patent 11,141,474) in view of Pei (A thesis submitted to University of Chinese Academy of Science, June 2019 in IDS on August 14, 2026).
Rauch et al. teach immunogenic compositions comprising GII.4 norovirus virus-like particle comprising an amino acid sequence identical with present SEQ ID NO: 2, (see SEQ ID NO: 2438 in Rauch and a sequence alignment below), a sequence identical with present SEQ ID NO: 4 representing the GII2 norovirus (see SEQ ID NO: 1947 and a sequence alignment below), a sequence having 99.6% identity with present SEQ ID NO: 5 representing norovirus GII.6 (see SEQ ID NO: 2428 in Rauch and a sequence alignment below), and an amino acid sequence identical with present SEQ ID NO: 8 representing GII.17 (see SEQ ID NO: 1000) and kits comprising the norovirus virus-like particles (see claims 1-16, Examples 1-7, column 159).
Rauch discloses norovirus strains GII.1, GII.2, GII.3, GII.4, GII.5, GII.6, GII.7, GII.8, GII.9, GII.10, GII.11, GII.12, GII.13, GII.14, GII.15, GII.16, GII.17, GII.18, GII.19, GII.20, GII.21, GII.22, GII.23, and/or GII.24 (see column 29, lines 38-67, column 31, lines 25-67, column 32, and column 97). However, Rauch does not expressly teach a combination of GIL. 2, GIL. 4, GIL. 6 and GIL. 17 noroviruses virus-like particles.
Pei teaches a tetravalent norovirus vaccine comprising GII.1, GII.3, GII.4, and GII.17 (see Abstract). Pei teaches that a tetravalent norovirus vaccine comprising GII.1, GII.3, GII.4, and GII.17 is a promising candidate vaccine with broad spectrum protection against norovirus (see last paragraph in English).
I would have been prima facie obvious to provide Rauch’s norovirus composition comprising GIL. 2, GIL. 4, GIL. 6 and GIL. 17 noroviruses virus-like particles, together in one composition because Pei teaches that a tetravalent norovirus vaccine comprising GII.1, GII.3, GII.4, and GII.17 is a promising candidate vaccine with broad spectrum protection against norovirus (see last paragraph in English).
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Regarding present claims 1, 2, 14, 15, 21-24, 26-28. Pei teaches a method of inducing an immune response to the norovirus GII.1, GII.3, GII.4, and GII.17 comprising administering a tetravalent norovirus vaccine comprising GII.1, GII.3, GII.4, and GII.17 is a promising candidate vaccine with broad spectrum protection against norovirus (see last paragraph in English).
Rauch et al. teach immunogenic compositions comprising GII.4 norovirus virus-like particle comprising an amino acid sequence identical with present SEQ ID NO: 2, (see SEQ ID NO: 2438 in Rauch and a sequence alignment below), a sequence identical with present SEQ ID NO: 4 representing the GII2 norovirus (see SEQ ID NO: 1947 and a sequence alignment below), a sequence having 99.6% identity with present SEQ ID NO: 5 representing norovirus GII.6 (see SEQ ID NO: 2428 in Rauch and a sequence alignment below), and an amino acid sequence identical with present SEQ ID NO: 8 representing GII.17 (see SEQ ID NO: 1000) and kits comprising the norovirus virus-like particles (see claims 1-16, Examples 1-7, column 159).
Present SEQ ID NO: 2 and SEQ ID NO: 2438 in Rauch)
Query Match 100.0%; Score 2880; Length 542;
Best Local Similarity 100.0%;
Matches 542; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKMASNDAAPSTDGAAGLVPESNNEVMALEPVAGAALAAPVTGQTNIIDPWIRANFVQAP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKMASNDAAPSTDGAAGLVPESNNEVMALEPVAGAALAAPVTGQTNIIDPWIRANFVQAP 60
Qy 61 NGEFTVSPRNAPGEVLLNLELGPELNPYLAHLARMYNGYAGGMEVQVMLAGNAFTAGKLV
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NGEFTVSPRNAPGEVLLNLELGPELNPYLAHLARMYNGYAGGMEVQVMLAGNAFTAGKLV 120
Qy 121 FAAVPPHFPVENLSPQQITMFPHVIIDVRTLEPVLLPLPDVRNNFFHYNQKDDPKMRIVA
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 FAAVPPHFPVENLSPQQITMFPHVIIDVRTLEPVLLPLPDVRNNFFHYNQKDDPKMRIVA 180
Qy 181 MLYTPLRSNGSGDDVFTVSCRVLTRPSPDFDFTYLVPPTVESKTKPFTLPILTLGELSNS
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 MLYTPLRSNGSGDDVFTVSCRVLTRPSPDFDFTYLVPPTVESKTKPFTLPILTLGELSNS 240
Qy 241 RFPVSIDQMYTSPNEIISVQCQNGRCTLDGELQGTTQLQVSGICAFKGEVTAHLHDNDHL
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 RFPVSIDQMYTSPNEIISVQCQNGRCTLDGELQGTTQLQVSGICAFKGEVTAHLHDNDHL 300
Qy 301 YNVTITNLNGSPFDPSEDIPAPLGVPDFQGRVFGIISQRDKHNSPGHNEPANRGHDAVVP
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 YNVTITNLNGSPFDPSEDIPAPLGVPDFQGRVFGIISQRDKHNSPGHNEPANRGHDAVVP 360
Qy 361 TYTAQYTPKLGQIQIGTWQTDDLTVNQPVKFTPVGLNDTEHFNQWVVPRYAGALNLNTNL
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 TYTAQYTPKLGQIQIGTWQTDDLTVNQPVKFTPVGLNDTEHFNQWVVPRYAGALNLNTNL 420
Qy 421 APSVAPVFPGERLLFFRSYIPLKGGYGNPAIDCLLPQEWVQHFYQEAAPSMSEVALVRYI
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 APSVAPVFPGERLLFFRSYIPLKGGYGNPAIDCLLPQEWVQHFYQEAAPSMSEVALVRYI 480
Qy 481 NPDTGRALFEAKLHRAGFMTVSSNTSAPVVVPANGYFRFDSWVNQFYSLAPMGTGNGRRR
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 NPDTGRALFEAKLHRAGFMTVSSNTSAPVVVPANGYFRFDSWVNQFYSLAPMGTGNGRRR 540
Qy 541 VQ 542
||
Db 541 VQ 542
Present SEQ ID NO: 4 and SEQ ID NO: 1947 in Rauch)
Query Match 100.0%; Score 2886; Length 540;
Best Local Similarity 100.0%;
Matches 540; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKMASSDANPSDGSAANLVPEVNNEVMALEPVVGAAIA APVAGQQNVIDPWIRNNFVQAP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKMASSDANPSDGSAANLVPEVNNEVMALEPVVGAAIA APVAGQQNVIDPWIRNNFVQAP 60
Qy 61 GGEFTVSPRNAPGEILWSAPLGPDLNPYLSHLARMYNGYAGGFEVQVILAGNAFTAGKVI
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GGEFTVSPRNAPGEILWSAPLGPDLNPYLSHLARMYNGYAGGFEVQVILAGNAFTAGKVI 120
Qy 121 FAAVPPNFPTEGLSPSQVTMFPHIVVDVRQLEPVLIPLPDVRNNFYHYNQSNDPTIKLIA
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 FAAVPPNFPTEGLSPSQVTMFPHIVVDVRQLEPVLIPLPDVRNNFYHYNQSNDPTIKLIA 180
Qy 181 MLYTPLRANNAGDDVFTVSCRVLTRPSPDFDFIFLVPPTVESRTKPFSVPVLTVEEMTNS
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 MLYTPLRANNAGDDVFTVSCRVLTRPSPDFDFIFLVPPTVESRTKPFSVPVLTVEEMTNS 240
Qy 241 RFPIPLEKLFTGPSSAFVVQPQNGRCTTDGVLLGTTQLSPVNICTFRGDVTHITGSRNYT
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 RFPIPLEKLFTGPSSAFVVQPQNGRCTTDGVLLGTTQLSPVNICTFRGDVTHITGSRNYT 300
Qy 301 MNLASQNWNNYDPTEEIPAPLGTPDFVGKIQGVLTQTTRTDGSTRGHKATVYTGSADFAP
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 MNLASQNWNNYDPTEEIPAPLGTPDFVGKIQGVLTQTTRTDGSTRGHKATVYTGSADFAP 360
Qy 361 KLGRVQFETDTDHDFEANQNTKFTPVGVIQDGSTTHRNEPQQWVLPSYSGRNTHNVHLAP
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 KLGRVQFETDTDHDFEANQNTKFTPVGVIQDGSTTHRNEPQQWVLPSYSGRNTHNVHLAP 420
Qy 421 AVAPTFPGEQLLFFRSTMPGCSGYPNMDLDCLLPQEWVQYFYQEAAPAQSDVALLRFVNP
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 AVAPTFPGEQLLFFRSTMPGCSGYPNMDLDCLLPQEWVQYFYQEAAPAQSDVALLRFVNP 480
Qy 481 DTGRVLFECKLHKSGYVTVAHTGQHDLVIPPNGYFRFDSWVNQFYTLAPMGNGTGRRRAV
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 DTGRVLFECKLHKSGYVTVAHTGQHDLVIPPNGYFRFDSWVNQFYTLAPMGNGTGRRRAV 540
Present SEQ ID NO: 5 and SEQ ID NO: 2428 in Rauch
Query Match 99.6%; Score 2879; Length 547;
Best Local Similarity 99.3%;
Matches 543; Conservative 3; Mismatches 1; Indels 0; Gaps 0;
Qy 1 MKMASNDAAPSNDGAANLVPEATNEVMALEPVVGASIAAPVVGQQNIIDPWIRENFVQAP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKMASNDAAPSNDGAANLVPEATNEVMALEPVVGASIAAPVVGQQNIIDPWIRENFVQAP 60
Qy 61 QGEFTVSPRNSPGEMLLNLELGPELNPYLSHLSRMYNGYAGGMQVQVVLAGNAFTAGKII
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 QGEFTVSPRNSPGEMLLNLELGPELNPYLSHLSRMYNGYAGGMQVQVVLAGNAFTAGKII 120
Qy 121 FAAVPPHFPVENISAAQITMCPHVIVDVRQLEPVLLPLPDIRNRFFHYNQENTPRMRLVA
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 FAAVPPHFPVENISAAQITMCPHVIVDVRQLEPVLLPLPDIRNRFFHYNQENTPRMRLVA 180
Qy 181 MLYTPLRANSGEDVFTVSCRVLTRPAPDFEFTFLVPPTVESKTKPFTLPILTLGELSNSR
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 MLYTPLRANSGEDVFTVSCRVLTRPAPDFEFTFLVPPTVESKTKPFTLPILTLGELSNSR 240
Qy 241 FPAPIDMLYTDPNEAIVVQPQNGRCTLDGTLQGTTQLVPTQICSFRGTLVSQTSRSADST
|||||||||||||||||||||||||||||||||||||||||||||||||:||||||||||
Db 241 FPAPIDMLYTDPNEAIVVQPQNGRCTLDGTLQGTTQLVPTQICSFRGTLISQTSRSADST 300
Qy 301 DSAPRVRSHPLHVQLKNLDGTPYDPTDEVPAVLGAIDFKGTVFGVASQRNTTGNSIGATR
||||| |:||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 DSAPRARNHPLHVQLKNLDGTPYDPTDEVPAVLGAIDFKGTVFGVASQRNTTGNSIGATR 360
Qy 361 AHEVHIDTTNPRYTPKLGSVLMYSESNDFDDGQPTRFTPIGMGADDWHQWELPEYSGHLT
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 AHEVHIDTTNPRYTPKLGSVLMYSESNDFDDGQPTRFTPIGMGADDWHQWELPEYSGHLT 420
Qy 421 LNMNLAPALAPAFPGERILFFRSVVPSAGGYGSGHIDCLIPQEWVQHFYQEAAPSQSAVA
||||||||:|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 LNMNLAPAVAPAFPGERILFFRSVVPSAGGYGSGHIDCLIPQEWVQHFYQEAAPSQSAVA 480
Qy 481 LIRYVNPDTGRNIFEAKLHREGFITVANSGNNPIVVPPNGYFRFEAWVNQFYTLTPMGTG
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 LIRYVNPDTGRNIFEAKLHREGFITVANSGNNPIVVPPNGYFRFEAWVNQFYTLTPMGTG 540
Qy 541 QGRRRVQ 547
|||||||
Db 541 QGRRRVQ 547
Present SEQ ID NO: 8 and SEQ ID NO: 1000 in Rauch
Query Match 100.0%; Score 2879; Length 540;
Best Local Similarity 100.0%;
Matches 540; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKMASNDAAPSNDGAAGLVPEGNNETLPLEPVAGAAIA APVTGQNNIIDPWIRTNFVQAP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKMASNDAAPSNDGAAGLVPEGNNETLPLEPVAGAAIA APVTGQNNIIDPWIRTNFVQAP 60
Qy 61 NGEFTVSPRNSPGEILLNLELGPDLNPYLAHLSRMYNGYAGGVEVQVLLAGNAFTAGKIL
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NGEFTVSPRNSPGEILLNLELGPDLNPYLAHLSRMYNGYAGGVEVQVLLAGNAFTAGKIL 120
Qy 121 FAAVPPNFPVEFLSPAQITMLPHLIVDVRTLEPIMIPLPDVRNTFFHYSNQPNSRMRLVA
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 FAAVPPNFPVEFLSPAQITMLPHLIVDVRTLEPIMIPLPDVRNTFFHYSNQPNSRMRLVA 180
Qy 181 MLYTPLRSNGSGDDVFTVSCRVLTRPTPDFEFTYLVPPSVESKTKPFSLPILTLSELTNS
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 MLYTPLRSNGSGDDVFTVSCRVLTRPTPDFEFTYLVPPSVESKTKPFSLPILTLSELTNS 240
Qy 241 RFPVPIDSLFTAQNNVLQVQCQNGRCTLDGELQGTTQLLPSGICAFRGRVTAQINQRDRW
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 RFPVPIDSLFTAQNNVLQVQCQNGRCTLDGELQGTTQLLPSGICAFRGRVTAQINQRDRW 300
Qy 301 HMQLQNLNGTTYDPTDDVPAPLGTPDFKGVVFGMVSQRNVGNDAPGSTRAQQAWVSTYSP
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 HMQLQNLNGTTYDPTDDVPAPLGTPDFKGVVFGMVSQRNVGNDAPGSTRAQQAWVSTYSP 360
Qy 361 QFVPKLGSVNLRISDNDDFQFQPTKFTPVGVNDDDDGHPFRQWELPNYSGELTLNMNLAP
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 QFVPKLGSVNLRISDNDDFQFQPTKFTPVGVNDDDDGHPFRQWELPNYSGELTLNMNLAP 420
Qy 421 PVAPNFPGEQLLFFRSFVPCSGGYNQGIIDCLIPQEWIQHFYQESAPSQSDVALIRYVNP
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 PVAPNFPGEQLLFFRSFVPCSGGYNQGIIDCLIPQEWIQHFYQESAPSQSDVALIRYVNP 480
Qy 481 DTGRTLFEAKLHRSGYITVAHSGDYPLVVPANGHFRFDSWVNQFYSLAPMGTGNGRRRAQ
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 DTGRTLFEAKLHRSGYITVAHSGDYPLVVPANGHFRFDSWVNQFYSLAPMGTGNGRRRAQ 540
Regarding present claims 6-9. Rauch discloses norovirus strains GII.1, GII.2, GII.3, GII.4, GII.5, GII.6, GII.7, GII.8, GII.9, GII.10, GII.11, GII.12, GII.13, GII.14, GII.15, GII.16, GII.17, GII.18, GII.19, GII.20, GII.21, GII.22, GII.23, and/or GII.24 (see column 29, lines 38-67, column 31, lines 25-67, column 32, and column 97). Since Rauch discloses all GIL. 2, GIL. 4, GIL. 6 and GIL. 17, required by present claim 6, Rauch anticipates this strain combination. However claims 6-9 are also rejected under 103 rejection below.
Regarding present claims 21-26. Rauch discloses aluminum hydroxide, TLR9, CPG, and Saponin, QS21 adjuvants (see column 14, lines 1-39, columns 119, 120 and 124-125).
I would have been prima facie obvious to provide Rauch’s norovirus composition comprising GIL. 2, GIL. 4, GIL. 6 and GIL. 17 noroviruses virus-like particles, together in one composition because Pei teaches that a tetravalent norovirus vaccine comprising GII.1, GII.3, GII.4, and GII.17 is a promising candidate vaccine with broad spectrum protection against norovirus (see last paragraph in English).
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Rauch et al., (US Patent 11,141,474) in view of Pei (A thesis submitted to University of Chinese Academy of Science, June 2019) as applied to claims 1 and 24 and further in view of Du et al. (US Patent 9,878,035).
Rauch teach the claimed invention as discussed above. Rauch does not teach CpG adjuvant of present SEQ ID NO: 9.
Du et al. teach hepatitis virus vaccine comprising a CpG adjuvant identical with present SEQ ID NO: 9 (see SEQ ID NO: 3 in Rauch and sequence alignment below).
Query Match 100.0%; Score 21; Length 21;
Best Local Similarity 100.0%;
Matches 21; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TCGTTCGTTCGTTCGTTCGTT 21
|||||||||||||||||||||
Db 1 TCGTTCGTTCGTTCGTTCGTT 21
I would have been prima facie obvious to provide Rauch’s norovirus composition comprising Du’s CpG adjuvant identical with present SEQ ID NO: 9, because Du teaches that his adjuvant contributes to generating protecting immune responses in vaccinated humans (see claims 1-9, and Examples 1-12).
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Pertinent References
Arntzen et al. (US Patent Application Publication US 2013/0095134) disclose norovirus VLPs.
Contact Information
Applicants’ amendment and IDS necessitated new ground of rejection. Accordingly,
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 extension fee 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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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
Prosecution Insights