Porcine circovirus and paravovirus vaccine

Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Combination of antigens from multiple viral species

Reexamination Certificate

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C424S201100, C424S264100, C424S257100, C424S229100, C424S220100, C424S209100, C424S199100, C424S815000, C514S04400A, C435S235100, C435S810000

Reexamination Certificate

active

06217883

ABSTRACT:

This application claims priority from French application No. 98 08777, filed Jul. 6, 1998. Reference is also made to U.S. application Ser. No. 09/161,092, filed Sep. 25, 1998 as a continuation-in-part of U.S. application Ser. No. 09/082,558, filed May 21, 1998, claiming priority from French applications Nos. 97 12382, 98 00873 and 98 03707, filed Oct. 3, 1997, Jan. 22, 1998 and Mar. 20, 1998, respectively. Reference is further made to the U.S. applications of Audonnet et al. and Bublot et al., Ser. Nos. 60/138,352 and 60/138,478, respectively, both filed Jun. 10, 1999 (“DNA VACCINE-PCV”, and “PORCINE CIRCOVIRUS RECOMBINANT POXVIRUS VACCINE”, respectively; attorney dockets 454313-2335 and TH-015, respectively). Reference is additionally made to each of the documents cited in the text and in the record or prosecution of each of the aforementioned U.S. and French applications, including without limitation WO 98/03658, published Jan. 29, 1998 from PCT/FR97/01313, filed Jul. 15, 1997 and designating the U.S. and claiming priority from French application 96 09338, filed Jul. 19, 1996 (the U.S. continuation-in-part of PCT/FR97/01313 being U.S. application Ser. No. 09/232,468, filed Jan. 15, 1999). Each of the aforementioned U.S., PCT and French applications (including parenthetically), and each document cited in the text and the record or prosecution of each of the aforementioned U.S., PCT and French applications (including parenthetically), is hereby incorporated herein by reference; and, technology in each of the aforementioned U.S., PCT and French applications (including parenthetically), and each document cited in the text and the record or prosecution of each of the aforementioned U.S., PCT and French applications (including parenthetically) can be used in the practice of this invention.
Furthermore, with respect to equivalent sequences capable of hybridizing under high stringency conditions or having a high homology with nucleic acid molecules employed in the invention, “hybridizing under high stringency conditions” can be synonymous with “stringent hybridization conditions”, a term which is well known in the art; see, for example, Sambrook, “Molecular Cloning, A Laboratory Manual” second ed., CSH Press, Cold Spring Harbor, 1989; “Nucleic Acid Hybridisation, A Practical Approach”, Hames and Higgins eds., IRL Press, Oxford, 1985; both incorporated herein by reference. With respect to nucleic acid molecules and polypeptides which can be used in the practice of the invention, the nucleic acid molecules and polypeptides advantageously have at least about 84 to 85% or greater homology or identity, such as at least about 85% or about 86% or about 87% or about 88% or about 89% homology or identity, for instance at least about 90% or homology or identity or greater, such as at least about 91%, or about 92%, or about 93%, or about 94% identity or homology, more advantageously at least about 95% to 99% homology or identity or greater, such as at least about 95% homology or identity or greater e.g., at least about 96%, or about 97%, or about 98%, or about 99%, or even about 100% identity or homology, or from about 84 to about 100% or from about 90 to about 99 or about 100% or from about 95 to about 99 or about 100% identity or homology, with respect to sequences disclosed or described herein and fragments thereof herein disclosed or described (including subsequences discussed below); and thus, the invention comprehends a vector encoding an epitope or epitopic region of a PCV isolate or a composition comprising such an epitope, compositions comprising an epitope or epitopic region of a PCV isolate, and methods for making and using such vectors and compositions, e.g., the invention also comprehends that these nucleic acid molecules and polypeptides can be used in the same fashion as the herein mentioned nucleic acid molecules, fragments thereof and polypeptides. In this regard, it is noted that homology between PCV1 and PCV2 is about 84% to about 85% and that within the PCV2 group homology is from about 95% to about 99%.
Nucleotide sequence homology can be determined using the “Align” program of Myers and Miller, (“Optimal Alignments in Linear Space”, CABIOS 4, 11-17, 1988, incorporated herein by reference) and available at NCBI. Alternatively or additionally, the term “homology” or “identity”, for instance, with respect to a nucleotide or amino acid sequence, can indicate a quantitative measure of homology between two sequences. The percent sequence homology can be calculated as (N
ref
−N
dif
)* 100/N
ref
, wherein N
dif
is the total number of non-identical residues in the two sequences when aligned and wherein N
ref
is the number of residues in one of the sequences. Hence, the DNA sequence AGTCAGTC will have a sequence similarity of 75% with the sequence AATCAATC (N
ref
=8; N
dif
=2).
Alternatively or additionally, “homology” or “identity” with respect to sequences can refer to the number of positions with identical nucleotides or amino acids divided by the number of nucleotides or amino acids in the shorter of the two sequences wherein alignment of the two sequences can be determined in accordance with the Wilbur and Lipman algorithm (Wilbur and Lipman, 1983 PNAS USA 80:726, incorporated herein by reference), for instance, using a window size of 20 nucleotides, a word length of 4 nucleotides, and a gap penalty of 4, and computer-assisted analysis and interpretation of the sequence data including alignment can be conveniently performed using commercially available programs (e.g., Intelligenetics™ Suite, Intelligenetics Inc. Calif.). When RNA sequences are said to be similar, or have a degree of sequence identity or homology with DNA sequences, thymidine (T) in the DNA sequence is considered equal to uracil (U) in the RNA sequence (see also alignment used in Figures and in Appendix I). RNA sequences within the scope of the invention can be derived from DNA sequences, by thymidine (T) in the DNA sequence being considered equal to uracil (U) in RNA sequences.
Additionally or alternatively, amino acid sequence similarity or identity or homology can be determined using the BlastP program (Altschul et al., Nucl. Acids Res. 25, 3389-3402, incorporated herein by reference) and available at NCBI (used in determining sequence homology, as shown in Appendix I; see also the Examples). The following references (each incorporated herein by reference) also provide algorithms for comparing the relative identity or homology of amino acid residues of two proteins, and additionally or alternatively with respect to the foregoing, the teachings in these references can be used for determining percent homology or identity: Needleman S B and Wunsch C D, “A general method applicable to the search for similarities in the amino acid sequences of two proteins,”
J. Mol. Biol.
48:444-453 (1970); Smith T F and Waterman M S, “Comparison of Bio-sequences,”
Advances in Applied Mathematics
2:482-489 (1981); Smith T F, Waterman M S and Sadler J R, “Statistical characterization of nucleic acid sequence functional domains,”
Nucleic Acids Res.,
11:2205-2220 (1983); Feng D F and Dolittle R F, “Progressive sequence alignment as a prerequisite to correct phylogenetic trees,”
J. of Molec. Evol.,
25:351-360 (1987); Higgins D G and Sharp P M, “Fast and sensitive multiple sequence alignment on a microcomputer,”
CABIOS,
5:151-153 (1989); Thompson J D, Higgins D G and Gibson T J, “ClusterW: improving the sensitivity of progressive multiple sequence alignment through sequence weighing, positions-specific gap penalties and weight matrix choice,
Nucleic Acid Res.,
22:4673-480 (1994); and, Devereux J, Haeberlie P and Smithies O, “A comprehensive set of sequence analysis program for the VAX,”
Nucl. Acids Res.,
12: 387-395 (1984).
The disclosed nucleic acid sequences or portions or fragments thereof, e.g., subsequences comprising at least about 12 nucleotides in length, for instance, at least about 15, about 18, about 21, about 24 or about 27 nucleotides in length, such as at least about 30, about 33, abo

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