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 preliminary amendment filed on March 28, 2024 is acknowledged. Claims 1-28 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on June 29, 2023, August 25, 2025, March 14, 2025 and February 5, 2025 have 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 therefor, subject to the conditions and requirements of this title.
Claims 1-10, 12-20 and 27-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. 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 1-5, 10-15 and 21-28 are directed to A G11.4 norovirus virus-like particle or active fragment thereof for inducing an immune response to multiple genotypes of noroviruses in an animal, wherein the G11.4 norovirus virus-like particle or active fragment thereof comprises or is composed of one amino acid sequence selected from a group consisting of: (1) an amino acid sequence shown as SEQ ID NO: 4; (2) an amino acid sequence having an identity of at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or more to the amino acid sequence shown as SEQ ID NO: 4; (3) an amino acid sequence having an amino acid substitution, deletion or insertion at one or more sites in the amino acid sequence shown as SEQ ID NO: 4; and (4) a segment of consecutive amino acids from position X to position 480 in the amino acid sequence shown as SEQ ID NO: 4, wherein X is an integer between 2 and 39.
Claims 6-9, 16-20 and drawn to A composition for inducing an immune response to a norovirus, comprising GIL. 2, GIL. 4, GIL. 6 and GIL. 17 noroviruses virus-like particles or active fragments thereof.
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.
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.
Claims 11 and 21-26 are not rejected because they require the presence of an adjuvant in addition to the naturally occurring norovirus particle. Claims 11 and 21-26 recite significantly more than the judicial exception.
Since claims 1-10, 12-20 and 27-28 recite the judicial exception they are rejected as directed to non-statutory subject matter.
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 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.
Claims 9, 16 and 18 are directed to A G11.4 norovirus virus-like particle or active fragment thereof for inducing an immune response to multiple genotypes of noroviruses in an animal, wherein the G11.4 norovirus virus-like particle or active fragment thereof comprises or is composed of one amino acid sequence selected from a group consisting of: (1) an amino acid sequence shown as SEQ ID NO: 4; (2) an amino acid sequence having an identity of at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or more to the amino acid sequence shown as SEQ ID NO: 4; (3) an amino acid sequence having an amino acid substitution, deletion or insertion at one or more sites in the amino acid sequence shown as SEQ ID NO: 4; and (4) a segment of consecutive amino acids from position X to position 480 in the amino acid sequence shown as SEQ ID NO: 4, wherein X is an integer between 2 and 39.
Examiner notes that position X is not found in present SEQ ID NO: 4. It is not clear whether Applicant intends to claim an insertion within SEQ ID NO: 4 or a substitution of amino acids into SEQ ID NO: 4. The metes and bounds of the segment of consecutive amino acids from position X to position 480 in the amino acid sequence shown as SEQ ID NO: 4, wherein X is an integer between 2 and 39 cannot be determined.
Clarification and/or correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected 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.
Claim 9 is drawn to the composition according to any one of claims 6 to 8 claim 6, wherein the norovirus is one or more selected from a group consisting of GI. 1, GII. 2, GII. 4, GII. 6, GII. 7, GII. 12 and GII. 17 noroviruses.
Claim 9 fails to further limit claim 6, because it recites additional strains of norovirus, such as GI. 1, GII.7 and GII.12, that are not recited in the independent claim 6, without reciting that the additional norovirus strains are further comprised in the composition.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Correction is required.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-28 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims are directed to A G11.4 norovirus virus-like particle or active fragment thereof for inducing an immune response to multiple genotypes of noroviruses in an animal, wherein the G11.4 norovirus virus-like particle or active fragment thereof comprises or is composed of one amino acid sequence selected from a group consisting of: (1) an amino acid sequence shown as SEQ ID NO: 4; (2) an amino acid sequence having an identity of at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or more to the amino acid sequence shown as SEQ ID NO: 4; (3) an amino acid sequence having an amino acid substitution, deletion or insertion at one or more sites in the amino acid sequence shown as SEQ ID NO: 4; and (4) a segment of consecutive amino acids from position X to position 480 in the amino acid sequence shown as SEQ ID NO: 4, wherein X is an integer between 2 and 39.
Claims are rejected because of lack of an adequate structure and function correlation between 1) active fragments of norovirus virus-like particle, 2) partial structure having at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% of SEQ ID NO: 4, 3) an amino acid sequence having an amino acid substitution, deletion or insertion and 4) amino acids from position X to position 480 in the amino acid sequence shown as SEQ ID NO: 4, wherein X is an integer between 2 and 39 and the required function of the claimed composition of inducing an immune response to the norovirus. The present claims recite a partial structure
Applicant’s specification provides working examples showing immunization of animals with norovirus VLP proteins comprising SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8 or 12 (Examples 1 and 2) and detection of antibody immune responses (Examples 3 and 4).
Applicant’s specification fails to provide working examples showing generation of protective immune responses due to immunization of animals with norovirus particles 1) active fragments of norovirus virus-like particle, 2) partial structure having at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% of SEQ ID NO: 4, 3) an amino acid sequence having an amino acid substitution, deletion or insertion and 4) amino acids from position X to position 480 in the amino acid sequence shown as SEQ ID NO: 4, wherein X is an integer between 2 and 39 and the required function of inducing an immune response to the norovirus.
Thus, because of lack of structure and function correlation between the claimed fragments and the function of generating an immune response, the present claims are rejected for lack of written description.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-24 and 26-28 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rauch et al., (US Patent 11,141,474).
Regarding present claims 1-10, 12-20 and 27-28. 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 11 and 21-26. Rauch discloses aluminum hydroxide, TLR9, CPG, and Saponin, QS21 adjuvants (see column 14, lines 1-39, columns 119, 120 and 124-125).
Thus, by this disclosure Rauch anticipate the present claims.
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 6-9, 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rauch et al., (US Patent 11,141,474).
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.
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 Rauch teaches all GIL. 2, GIL. 4, GIL. 6 and GIL. 17.
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) 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.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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