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
Claims 1, 5, 8, 9, 10, 11, 15, 18, 19, 23, 34, 40, 46, 47, and 130 are pending.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 1, 5, 10-11, 15, 18-19, 23, 34, 40, 46, 47, and 130 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Feinberg et al (WO2005028634 A1; Published 3/31/2005),
Feinberg teaches a fusion polypeptide comprising an amino acid sequence of instantly claimed SEQ ID NO: 359. [see sequence alignments below], Feinberg teaches that the full-length of the fusion polypeptide comprises polypeptide segments encoded by HIV-1 genes Pol and Env, is at least 335 amino acids and up to 970 amino acids, wherein the fusion polypeptide is capable of inducing, promoting or stimulating proliferation and/or activation of one or more cell types selected from monocyte-derived dendritic cells (DCs), CD8+ T cells, and CD4+ T-cells. [pg 8, lines 16-19, claim 29; pg 40 lines 16-25-pg 41] Regarding claim 5, Feinberg teaches that the fusion polypeptide does not comprise an HIV-1 Pol polypeptide segment comprising amino acid sequence YMDD (SEQ ID NO: 462) or YVDD (SEQ ID NO: 463). Regarding claim 10, Feinberg teaches a polynucleotide encoding one or more fusion polypeptides of claim 1
Regarding claim 11, Feinberg teaches that the polynucleotide comprises cDNA or MRNA. [pg 16, lines 21-25 – pg 17 lines 1-10; pg 31] Regarding claim 15, Feinberg teaches an expression cassette comprising a polynucleotide of claim 10 operably linked to one or more regulatory sequences. [pg 28, lines 4-10] Regarding claims 18 and 19, Feinberg teaches a vector comprising one or more polynucleotides of claim 10, wherein the vector is a plasmid vector, a bacterial vector or a viral vector. Regarding claim 23, Feinberg Viral vector is from a virus from the family of poxvirdiae. [pg 43] Regarding claim 34, Feinberg teaches a host cell comprising one or more polynucleotides. Regarding claim 40, Feinberg teaches an immunogenic composition comprising one or more of the fusion polypeptides and a pharmaceutically acceptable carrier (40) Regarding claim 46, Feinberg teaches A pharmaceutical composition comprising one or more fusion polypeptides of claim 1 and a carrier. [pg 14, lines 1-14; pg 50] Regarding claim 130, Feinberg teaches that the fusion polypeptide comprises an amino acid sequence of instantly claimed SEQ ID NO: 364. [see sequence alignment below]
SEQUENCE ALIGNMENT:
SEQ ID NO: 359
RESULT 7
ADY99929
ID ADY99929 standard; protein; 2602 AA.
XX
AC ADY99929;
XX
DT 16-JUN-2005 (first entry)
XX
DE Human codon-optmized HIV B Gag-Pol-Env-Nef fusion protein.
XX
KW gag; pol; env; nef; fusion protein; viral replication; recombinant DNA;
KW vector; vaccine; cancer; infectious disease; HIV; hepatitis;
KW variola virus infection; immune stimulation; antimicrobial; virucide;
KW anti-HIV; cytostatic; antiinflammatory; hepatotropic; immunogenicity.
XX
OS Homo sapiens.
OS Human immunodeficiency virus 1.
XX
CC PN WO2005028634-A2.
XX
CC PD 31-MAR-2005.
XX
CC PF 20-SEP-2004; 2004WO-US030849.
XX
PR 18-SEP-2003; 2003US-0504030P.
XX
CC PA (UYEM-) UNIV EMORY.
XX
CC PI Feinberg MMD, Garber D;
XX
DR WPI; 2005-254126/26.
DR N-PSDB; ADY99928.
XX
CC PT New recombinant modified vaccinia Ankara virus comprising first null
CC PT mutation in vaccinia gene, useful for treating or preventing viral
CC PT infection (e.g. HIV, hepatitis and smallpox), and cancer.
XX
CC PS Claim 69; SEQ ID NO 57; 324pp; English.
XX
CC This invention relates to a novel recombinant modified vaccinia Ankara
CC virus (rMVA). Specifically, it refers to the use of rMVA vectors in the
CC development of vaccines to protect against cancer or infectious viral
CC diseases such as HIV, hepatitis and smallpox. The present invention
CC describes introducing a null mutation (preferably a deletion) into a
CC vaccinia gene that is necessary for replication of the rMVA, in
CC particular an exemplary gene is the vaccinia uracil DNA glycosylase gene.
CC Additional vaccinia genes that can contain null mutations include, but
CC are not limited to, IL1 beta receptor, A46R, IL-18BP, A41L and E3L.
CC Accordingly, it provides a system for producing an appropriate vaccine
CC that involves an immortalized, non-transformed avian fibroblast cell
CC infected with the rMVA, where the cell is from a complementing cell line
CC that is engineered to express the gene necessary for viral replication,
CC such that the virus is able to propagate. Furthermore, the rMVA may
CC include a heterologous nucleic acid sequence encoding an antigen or a
CC fragment thereof derived from viral, animal or plant polynucleotides, for
CC example this may include an antigen from the HIV virus, measles virus,
CC SARS virus, influenza virus, malaria plasmodium, tuberculosis Bacillus,
CC yellow fever virus, dengue flavivirus or the river blindness nematode.
CC The rMVA also comprises a second heterologous nucleic acid sequence
CC encoding a pro-apoptotic, anti-apoptotic or an immunomodulator operably
CC linked to an early stage viral promoter. As such, the developed vaccine
CC can be administered in a sufficient amount to effect an immune response
CC in a host and exhibits antimicrobial, virucide, anti-HIV, cytostatic,
CC antiinflammatory and hepatotropic activities. This polypeptide sequence
CC is a human codon-optimized HIV-1 consensus fusion protein sequence,
CC encoded by an antigenic sequence of an MVA-based vector given in an
CC exemplification of the invention.
XX
SQ Sequence 2602 AA;
Query Match 60.2%; Score 1524; Length 2602;
Best Local Similarity 27.1%;
Matches 404; Conservative 1; Mismatches 0; Indels 1086; Gaps 3;
Qy 1 GTVLVGPTPVNIIGRNLLTQIGCTLNFPISPIETVPVKLKPGMDGPKVKQWPLTEEKIKA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 636 GTVLVGPTPVNIIGRNLLTQIGCTLNFPISPIETVPVKLKPGMDGPKVKQWPLTEEKIKA 695
Qy 61 LVEICTEMEKEGKISKIGPENPYNTPVFAIKKKDSTKWRKLVDFRELNKRTQDFWEVQLG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 696 LVEICTEMEKEGKISKIGPENPYNTPVFAIKKKDSTKWRKLVDFRELNKRTQDFWEVQLG 755
Qy 121 IPHPAGLKKKKSVTVLDVGDAYFSVPLDKDFRKYTAFTIPSINNETPGIRYQYNVLPQGW 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 756 IPHPAGLKKKKSVTVLDVGDAYFSVPLDKDFRKYTAFTIPSINNETPGIRYQYNVLPQGW 815
Qy 181 KGSPAIFQSSM------------------------------------------------- 191
|||||||||||
Db 816 KGSPAIFQSSMTKILEPFRKQNPDIVIYQYMNDLYVGSDLEIGQHRTKIEELRQHLLRWG 875
Qy 192 ------------------------------------------------------------ 191
Db 876 FTTPDKKHQKEPPFLWMGYELHPDKWTVQPIVLPEKDSWTVNDIQKLVGKLNWASQIYAG 935
Qy 192 ------------------------------------------------------------ 191
Db 936 IKVKQLCKLLRGTKALTEVIPLTEEAELELAENREILKEPVHGVYYDPSKDLIAEIQKQG 995
Qy 192 ------------------------------------------------------------ 191
Db 996 QGQWTYQIYQEPFKNLKTGKYARMRGAHTNDVKQLTEAVQKIATESIVIWGKTPKFKLPI 1055
Qy 192 ------------------------------------------------------------ 191
Db 1056 QKETWETWWTEYWQATWIPEWEFVNTPPLVKLWYQLEKEPIVGAETFYVDGAANRETKLG 1115
Qy 192 ------------------------------------------------------------ 191
Db 1116 KAGYVTDRGRQKVVSLTDTTNQKTELQAIHLALQDSGLEVNIVTDSQYALGIIQAQPDKS 1175
Qy 192 ------------------------------------------------------------ 191
Db 1176 ESELVSQIIEQLIKKEKVYLAWVPAHKGIGGNEQVDKLVSAGIRKVLFLDGIDKAQEEHE 1235
Qy 192 ------------------------------------------------------------ 191
Db 1236 KYHSNWRAMASDFNLPPVVAKEIVASCDKCQLKGEAMHGQVDCSPGIWQLDCTHLEGKII 1295
Qy 192 --------------------------------------------------TTVKAACWWA 201
||||||||||
Db 1296 LVAVHVASGYIEAEVIPAETGQETAYFLLKLAGRWPVKTIHTDNGSNFTSTTVKAACWWA 1355
Qy 202 GIKQEFGIPYNPQSQGVVESMNKELKKIIGQVRDQAEHLKTAVQMAVFIHNFKRKGGIGG 261
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1356 GIKQEFGIPYNPQSQGVVESMNKELKKIIGQVRDQAEHLKTAVQMAVFIHNFKRKGGIGG 1415
Qy 262 YSAGERIVDII------------------------------------------------- 272
|||||||||||
Db 1416 YSAGERIVDIIATDIQTKELQKQITKIQNFRVYYRDSRDPLWKGPAKLLWKGEGAVVIQD 1475
Qy 273 ------------------------------------------------------------ 272
Db 1476 NSDIKVVPRRKAKIIRDYGKQMAGDDCVASRQDEDQLLNFDLLKLAGDVESNPGPGWATM 1535
Qy 273 ------------------------------------------------------------ 272
Db 1536 RVKGIRKNYQHLWRWGTMLLGMLMICSAAEQLWVTVYYGVPVWKEATTTLFCASDAKAYD 1595
Qy 273 ------------------------------------------------------------ 272
Db 1596 TEVHNVWATHACVPTDPNPQEVVLENVTENFNMWKNNMVEQMHEDIISLWDQSLKPCVKL 1655
Qy 273 ------------------------------------------------------------ 272
Db 1656 TPLCVTLNCTDLRNATNTTSSSWETMEKGEIKNCSFNITTSIRDKVQKEYALFYNLDVVP 1715
Qy 273 -------------------------------------------------------NVSTV 277
|||||
Db 1716 IDNASYRLISCNTSVITQACPKVSFEPIPIHYCAPAGFAILKCNDKKFNGTGPCTNVSTV 1775
Qy 278 QCTHGIRPVVSTQLLLNGSLAEE------------------------------------- 300
|||||||||||||||||||||||
Db 1776 QCTHGIRPVVSTQLLLNGSLAEEEVVIRSENFTDNAKTIIVQLNESVEINCTRPNNNTRK 1835
Qy 301 ------------------------------------------------------------ 300
Db 1836 SINIGPGRALYTTGEIIGDIRQAHCNISRAKWNNTLKQIVIKLREQFGNKTIVFNQSSGG 1895
Qy 301 ------------------------------------------------------------ 300
Db 1896 DPEIVMHSFNCGGEFFYCNSTQLFTWNDTRKLNNTGRNITLPCRIKQIINMWQEVGKAMY 1955
Qy 301 ------------------------------------------------------------ 300
Db 1956 APPIRGQIRCSSNITGLLLTRDGGKDTNGTEIFRPGGGDMRDNWRSELYKYKVVKIEPLG 2015
Qy 301 ------KRRVVQREKRAVGIGAMFLGFLGAAGSTMGAASITLTVQARQLLSGIVQQQNNL 354
|||||||||||||||||||||||||||||||||:||||||||||||||||||||
Db 2016 VAPTKAKRRVVQREKRAVGIGAMFLGFLGAAGSTMGAASMTLTVQARQLLSGIVQQQNNL 2075
Qy 355 LRAIEAQQHLLQLTVWGIKQLQARVLAVERYLKDQQLLGIWGCSGKLICTT 405
|||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2076 LRAIEAQQHLLQLTVWGIKQLQARVLAVERYLKDQQLLGIWGCSGKLICTT 2126
SEQ ID NO: 364
RESULT 21
ADY99901
ID ADY99901 standard; protein; 1005 AA.
XX
AC ADY99901;
XX
DT 16-JUN-2005 (first entry)
XX
DE Human codon-optmized HIV B Pol protein.
XX
KW pol; viral replication; recombinant DNA; vector; vaccine; cancer;
KW infectious disease; HIV; hepatitis; variola virus infection;
KW immune stimulation; antimicrobial; virucide; anti-HIV; cytostatic;
KW antiinflammatory; hepatotropic; immunogenicity.
XX
OS Homo sapiens.
OS Human immunodeficiency virus 1.
XX
CC PN WO2005028634-A2.
XX
CC PD 31-MAR-2005.
XX
CC PF 20-SEP-2004; 2004WO-US030849.
XX
PR 18-SEP-2003; 2003US-0504030P.
XX
CC PA (UYEM-) UNIV EMORY.
XX
CC PI Feinberg MMD, Garber D;
XX
DR WPI; 2005-254126/26.
DR N-PSDB; ADY99900.
XX
CC PT New recombinant modified vaccinia Ankara virus comprising first null
CC PT mutation in vaccinia gene, useful for treating or preventing viral
CC PT infection (e.g. HIV, hepatitis and smallpox), and cancer.
XX
CC PS Claim 69; SEQ ID NO 29; 324pp; English.
XX
CC This invention relates to a novel recombinant modified vaccinia Ankara
CC virus (rMVA). Specifically, it refers to the use of rMVA vectors in the
CC development of vaccines to protect against cancer or infectious viral
CC diseases such as HIV, hepatitis and smallpox. The present invention
CC describes introducing a null mutation (preferably a deletion) into a
CC vaccinia gene that is necessary for replication of the rMVA, in
CC particular an exemplary gene is the vaccinia uracil DNA glycosylase gene.
CC Additional vaccinia genes that can contain null mutations include, but
CC are not limited to, IL1 beta receptor, A46R, IL-18BP, A41L and E3L.
CC Accordingly, it provides a system for producing an appropriate vaccine
CC that involves an immortalized, non-transformed avian fibroblast cell
CC infected with the rMVA, where the cell is from a complementing cell line
CC that is engineered to express the gene necessary for viral replication,
CC such that the virus is able to propagate. Furthermore, the rMVA may
CC include a heterologous nucleic acid sequence encoding an antigen or a
CC fragment thereof derived from viral, animal or plant polynucleotides, for
CC example this may include an antigen from the HIV virus, measles virus,
CC SARS virus, influenza virus, malaria plasmodium, tuberculosis Bacillus,
CC yellow fever virus, dengue flavivirus or the river blindness nematode.
CC The rMVA also comprises a second heterologous nucleic acid sequence
CC encoding a pro-apoptotic, anti-apoptotic or an immunomodulator operably
CC linked to an early stage viral promoter. As such, the developed vaccine
CC can be administered in a sufficient amount to effect an immune response
CC in a host and exhibits antimicrobial, virucide, anti-HIV, cytostatic,
CC antiinflammatory and hepatotropic activities. This polypeptide sequence
CC is a human codon-optimized HIV-1 consensus protein sequence, encoded by
CC an antigenic sequence of an MVA-based vector given in an exemplification
CC of the invention.
XX
SQ Sequence 1005 AA;
Query Match 37.5%; Score 1757.5; Length 1005;
Best Local Similarity 45.7%;
Matches 424; Conservative 63; Mismatches 136; Indels 305; Gaps 28;
Qy 14 LCGAVFVSARGTVLVGPTPVNIIGRNLLTQIGCTLNFPISPIETVPVKLKPGMDGPKVKQ 73
:|| | ||||||||||||||||||||||||||||||||||||||||||||||||||
Db 124 ICGH---KAIGTVLVGPTPVNIIGRNLLTQIGCTLNFPISPIETVPVKLKPGMDGPKVKQ 180
Qy 74 WPLTEEKIKALVEICTEMEKEGKISKIGPENPYNTPVFAIKKKDSTKWRKLVDFRELNKR 133
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 WPLTEEKIKALVEICTEMEKEGKISKIGPENPYNTPVFAIKKKDSTKWRKLVDFRELNKR 240
Qy 134 TQDFWEVQLGIPHPAGLKKKKSVTVLDVGDAYFSVPLDKDFRKYTAFTIPSINNETPGIR 193
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 TQDFWEVQLGIPHPAGLKKKKSVTVLDVGDAYFSVPLDKDFRKYTAFTIPSINNETPGIR 300
Qy 194 YQYNVLPQGWKGSPAIFQSSMTTVKAACWWAGIKQEFGIPYNPQSQGVV--ESMN----- 246
|||||||||||||||||||||| : |: |: :| : ||
Db 301 YQYNVLPQGWKGSPAIFQSSMTKILE-------------PFRKQNPDIVIYQYMNDLYVG 347
Qy 247 KELKKIIGQVRDQAEHL--------------------------------KTAVQMAVF-- 272
:|: ||| | : | | | || |
Db 348 SDLE--IGQHRTKIEELRQHLLRWGFTTPDKKHQKEPPFLWMGYELHPDKWTVQPIVLPE 405
Qy 273 -----IHNFKRKGG--------------------IGGYSAGERIV--------------- 292
::: :: | : | | ::
Db 406 KDSWTVNDIQKLVGKLNWASQIYAGIKVKQLCKLLRGTKALTEVIPLTEEAELELAENRE 465
Qy 293 ---------------DII---------------------NVST--------------VQC 302
|:| |: | |
Db 466 ILKEPVHGVYYDPSKDLIAEIQKQGQGQWTYQIYQEPFKNLKTGKYARMRGAHTNDVKQL 525
Qy 303 THGIRPVVSTQLLLNGSLAEEKRRV---------------------------------VQ 329
| :: : : ::: | : | : |
Db 526 TEAVQKIATESIVIWGKTPKFKLPIQKETWETWWTEYWQATWIPEWEFVNTPPLVKLWYQ 585
Qy 330 REKRAVGIGAMFLGFLGAAG--STMGAA-------------------------SITLTVQ 362
|| : :|| ||| : :| | :| | :|
Db 586 LEKEPI-VGAETFYVDGAANRETKLGKAGYVTDRGRQKVVSLTDTTNQKTELQAIHLALQ 644
Qy 363 ARQLLSGIVQQQNNLLRAIEAQQHLLQLTVWGIKQLQARVLAVERYLKDQQLLGIW---- 418
| || | |:|| : :| ::: :|: :| ::: |
Db 645 DSGLEVNIVTDSQYALGIIQAQPDKSE------SELVSQI--IEQLIKKEKVYLAWVPAH 696
Qy 419 -GCSG-----KLICT------------------------------------TVAKEIVAS 436
| | ||: ||||||||
Db 697 KGIGGNEQVDKLVSAGIRKVLFLDGIDKAQEEHEKYHSNWRAMASDFNLPPVVAKEIVAS 756
Qy 437 CDKCQLKGEAMHGQVDCSPGIWQLDCTHLEGKIILVAVHVASGYIEAEVIPAETGQETAY 496
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 757 CDKCQLKGEAMHGQVDCSPGIWQLDCTHLEGKIILVAVHVASGYIEAEVIPAETGQETAY 816
Qy 497 FLLKLAGRWPVKTL------------------WVTV--YYGVPVWKEAAFPQITLWQRPL 536
|||||||||||||: | : :|:| : : : : |
Db 817 FLLKLAGRWPVKTIHTDNGSNFTSTTVKAACWWAGIKQEFGIP-YNPQSQGVVESMNKEL 875
Qy 537 VTIKIGGQLKEAL--LDTGADDTVLEEMNLPGRWKPKMIGGIGGFIKVRQYDQAAAAHNV 594
|| ||::: | | | :| | |||||: :| :
Db 876 K--KIIGQVRDQAEHLKTAVQMAVFIH-----NFKRK--GGIGGY---------SAGERI 917
Qy 595 WATHACVPTDPNPQEAITKIQNFRVYYRDSRDPLWKGPAKLLWKGEGAVVIQDNSDIKVV 654
| |: ||||||||||||||||||||||||||||||||||||||||||||
Db 918 VDIIATDIQTKELQKQITKIQNFRVYYRDSRDPLWKGPAKLLWKGEGAVVIQDNSDIKVV 977
Qy 655 PRRKAKIIRDYGKQMAGDDCVASRQDED 682
||||||||||||||||||||||||||||
Db 978 PRRKAKIIRDYGKQMAGDDCVASRQDED 1005
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.
Claim(s) 1, 5, 8, 9, 10-11, 15, 18-19, 23, 34, 40, 46, 47 and 130 are rejected under 35 U.S.C. 103 as being unpatentable over Feinberg et al (WO2005028634 A1; Published 3/31/2005), in view of Chappell et al (US11254712 B2, Priority to: 03/301/2017).
The teachings of Feinberg are recited above. However, Feinberg does not explicitly teach that the fusion polypeptide comprises an N-terminal signal peptide or leader sequence as recited in claims 8 and 9.
Chappell teaches a HIV fusion protein or polypeptide as a vaccine. Chappell teaches the use of a leader sequence and/or an N-terminal signal peptide. Chappell teaches the use of colony stimulating factor 2 (CSF-2) and CD74. Chappell teaches the use of a leader sequence for targeting to the secretory pathway in a selected host cell.
It is noted that claims 8 and 9 require that the fusion polypeptide comprises an N-terminal signal peptide or leader sequence. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to attach an N-terminal signal peptide or leader sequence to the fusion polypeptide of Feinberg. One would have been motivated to, and have a reasonable expectation of success, because: (1) Feinberg and Chappell teaches expressing HIV fusion polypeptide as an immunogenic composition, and (2) Chappell teaches the routine use of a leader sequence and/or N-terminal signal peptide.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A ALSOMAIRY whose telephone number is (571)272-0027. The examiner can normally be reached Monday-Friday 7:30 AM to 5:30 PM.
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/SARAH A ALSOMAIRY/Examiner, Art Unit 1646
/Zachariah Lucas/Supervisory Patent Examiner, Art Unit 1600
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