1. A method for facilitating the identification, authentication or quality control of packaged products, which methodology comprises:
in a first marking phase:
obtaining data representative of an analytical specification of a chemical composition for the product;
processing and recording the data on a machine readable data storage means provided in direct mechanical association with the packaged product;
and in a second authentication phase:
applying a suitable data reader to the data storage means to read the recorded data and reconstruct the recorded analytical specification;
chemically analysing a sample of the product to obtain data representative of an analytical specification of the actual chemical composition for the product;
comparing the results of the said analysis with the recorded readings within predetermined tolerance limits to determine whether the packaged product meets the recorded analytical specification so as to identify, authenticate, or achieve quality control over, the packaged product.
2. A method in accordance with claim 1 wherein the data storage means is incorporated into or onto or as a part of the packaging.
3. A method in accordance with claim 1 wherein the same analysis method is used to generate a reference analytical specification to create reference data during the marking phase and to generate a measured analytical specification during the authentication phase.
4. A method in accordance with claim 1 wherein reference data is recorded further including additional compositional data derived from standards, reference specifications, predetermined tolerance parameters and the like.
5. A method in accordance with claim 1 comprising the marking phase being performed independently of the authentication phase.
6. A method in accordance with claim 1 comprising the authentication phase being performed independently of the marking phase.
7. A method in accordance with claim 1 wherein an analytical specification is generated by an analysis method comprising a method of obtaining a spectrum representative of the chemical composition of the product, wherein intensity data varies across a range of frequencies.
8. A method in accordance with claim 7 wherein an analytical spectrum is generated by nuclear magnetic resonance.
9. A method in accordance with claim 1 wherein the analytical spectrum is obtained by batch analysis of the product to be packaged, for example during manufacture or otherwise prior to or during packaging.
10. A method in accordance with claim 9 wherein the analytical spectrum is obtained by testing of a representative sample for each product or batch of products at the time of packaging, the marking phase of the methodology thus comprising the step of analysing a sample of the product, prior to or during packaging, to obtain data representative of at least of an analytical specification of the sampled composition, and thus indicative of a predetermined desired chemical composition for the batch of product, and the step of processing and recording the data on a machine readable data storage means provided in direct mechanical association with each product or unit of the batch of packaged product.
11. A method in accordance with claim 1 wherein the analytical specification comprises a two-dimensional range map of variable intensity information referenced against a test parameter across a range of values.
12. A method in accordance with claim 11 wherein the analytical specification comprises an analytical spectrum of variable intensity information referenced across a frequency range.
13. A method in accordance with claim 12 wherein the authentication phase of the methodology is modified to comprise the step of repeating the chemical analysis of the above marking phase to obtain data representative of an analytical specification of the actual chemical composition for the product.
14. A method in accordance with claim 1 wherein the data storage means comprise optically, electronically and magnetically readable devices andor areas on or comprised as part of the packaging.
15. A method in accordance with claim 14 wherein the data is stored on data storage means comprising optically readable areas having a graduated scale such that data is stored by the position and also by the intensity, shade, tone, colour, hue or the like of an optically readable mark.
16. A method in accordance with claim 15 wherein the analytical specification comprises intensity data mapped across a measured analytical range, and is recorded such that position on the marking corresponds to the range, and in that the shading, tone, colour, hue or the like corresponds to intensity.
17. A method in accordance with claim 15 wherein the data storage means comprises an optically readable grey-scale marking.
18. A system for the identification, authentication and quality control of packaged products comprising:
a marking system comprising:
a machine readable data storage means provided in direct mechanical association with the packaged product, in particular being incorporated into or onto or as a part of such packaging; and
a marking device for processing data representative of an analytical specification of a chemical composition for the product and recording the data on the data storage means in readable form;
an authentication system comprising:
an authentication device comprising a suitable data reader to read the recorded data on the data storage means and reconstruct the analytical specification; and
a chemical analyzer to perform a subsequent analysis of a sample of the product to obtain data representative of aspects of the actual chemical composition for the product; and
a means to compare the results of the said analysis with the recorded specification within predetermined tolerance limits to determine whether the packaged product meets the recorded analytical specification so as to identify, authenticate, or achieve quality control over, the packaged product.
19. A system in accordance with claim 18 wherein the marking system is provided in association with a chemical analyzer adapted to carry out an identical analysis to that carried out by the authentication system, to analyse a sample of the product to obtain the said analytical specification prior to or during packaging, and data processing means to collect and process the data and convert to a reference mark for application by the marking system.
20. A system in accordance with claim 18 wherein the authentication system includes display means to display a result to a user.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
What is claimed:
1. A method for inducing an immune response in an animal, comprising:
(a) providing a composition comprising a polynucleotide encoding at least an immunogenic portion of a WT1 polypeptide, wherein the polynucleotide has at least 90% identity to SEQ ID NO:452, 389, 453, and 381, and
(b) administering said composition to the animal;
thereby inducing an immune response in the animal.
2. The method of claim 1, wherein said composition further comprises a component selected from the group consisting of a physiologically acceptable carrier and an adjuvant.
3. The method according to claim 1, wherein the WT1 polynucleotide is delivered by a viral based delivery system.
4. The method according to claim 3, wherein the viral based delivery system is an adenovirus.
5. The method according to claim 3, wherein the viral based delivery system is an alphavirus.
6. The method according to claim 1, wherein the WT1 polynucleotide is delivered as a naked DNA.
7. The method of claim 1, wherein the immune response induced is a CD8 cytotoxic T lymphocyte response.
9. The method of claim 1, wherein the immune response induced is both a CD4 T helper and CD8 cytotoxic T cell immune response.
10. A method for treating a malignancy associated with WT1 expression in a patient, comprising administering to the patient a composition comprising a first component selected from the group consisting of physiologically acceptable carriers and immunostimulants, and a second component comprising at least an immungenic portion of a WT1 polypeptide.
11. An isolated polypeptide comprising at least an immunogenic portion of the WT1 protein, wherein said polypeptide comprises the amino acid sequence set forth in SEQ ID NO:241.
12. The isolated polypeptide according to claim 11 wherein the polypeptide has been modified such that the ability of the polypeptide to bind to HLA-A2 is increased relative to that of the polypeptide set forth in SEQ ID NO:241.
13. The isolated polypeptide according to claim 12 wherein said polypeptide has increased immunogenicity relative to the polypeptide set forth in SEQ ID NO:241.
14. The isolated polypeptide according to claim 12 wherein said polypeptide comprises an amino acid sequence selected from the group consisting of any one of SEQ ID NOs:414-450.
15. The isolated polypeptide according to claim 11 wherein the polypeptide has been modified such that the ability of the polypeptide to bind to HLA-A2 is increased relative to that of the polypeptide set forth in SEQ ID NO:241.
16. The isolated polypeptide according to claim 15 wherein said modification comprises a substitution at position 1 (PI) of SEQ ID NO:241
17. The isolated polypeptide according to claim 15 wherein said modification comprises a substitution at position 2 (P2) of SEQ ID NO:241.
18. The isolated polypeptide according to claim 15 wherein said modification comprises a substitution at position 4 (P4) of SEQ ID NO:241.
19. The isolated polypeptide according to claim 15 wherein said modification comprises a substitution at position 6 (P6) of SEQ ID NO:241.
20. The isolated polypeptide according to claim 15 wherein said modification comprises a substitution at position 8 (P8) of SEQ ID NO:241.
21. The isolated polypeptide according to claim 15 wherein said modification comprises a substitution at position 9 (P9) of SEQ ID NO:241.
22. The isolated polypeptide according to claim 15 wherein said modification comprises a substitution at position 1 (P 1) and position 4 (P4) of SEQ ID NO:241.
23. The isolated polypeptide according to claim 15 wherein said modification comprises a substitution at position 1 (P1) and position 9 (P9) of SEQ ID NO:241.
24. The isolated polypeptide according to claim 15 wherein said modification comprises a substitution at position 1 (P1), position 4 (P4), and position 9 (P9) of SEQ ID NO:241.
25. The isolated polypeptide according to claim 15 wherein said modification comprises a substitution at position 6 (P6) and position 9 (P9) of SEQ ID NO:241.
26. An isolated polypeptide comprising at least an immunogenic portion of a WT1 polypeptide, wherein said immunogenic portion comprises an amino acid sequence selected from the group consisting of:
(i) a sequence set forth in SEQ ID NO:451; and
(ii) a polypeptide selected from the group consisting of:
(a) a sequence set forth in any one of SEQ ID NOs:414-450;
(b) a sequence having at least 70% identity to a sequence set forth in any one of SEQ ID NOs:414-450; and
(c) a sequence having at least 90% identity to a sequence set forth in any one of SEQ ID NOs:414-450;
wherein the ability of the polypeptide to bind to HLA-A2 is increased relative to that of the polypeptide set forth in SEQ ID NO:241.
27. A method for inducing an immune response in a mammal, comprising:
(a) providing a composition comprising a polynucleotide encoding the isolated polypeptide of claim 26; and
(b) administering said polynucleotide to the mammal;
thereby inducing an immune response in the mammal.
28. An expression vector comprising a polynucleotide of any one of the sequences set forth in SEQ ID NOs:452 and 453 or a polynucleotide encoding the isolated polypeptide of claim 26 operably linked to an expression control sequence.
29. A host cell transformed or transfected with an expression vector according to claim 28.
30. A method for stimulating andor expanding T cells specific for a tumor protein, comprising contacting T cells with at least one component selected from the group consisting of:
(a) a polypeptide according to claim 26;
(b) antigen-presenting cells pulsed with or that express a polypeptide according to claim 26,
under conditions and for a time sufficient to permit the stimulation andor expansion of T cells.
31. An isolated T cell population, comprising T cells prepared according to the method of claim 30.
32. A composition comprising a first component selected from the group consisting of physiologically acceptable carriers and immunostimulants, and a second component selected from the group consisting of:
(a) polypeptides according to claim 26; and
(b) T cells according to claim 31.
33. A method for stimulating an immune response in a patient, comprising administering to the patient a composition of claim 32.
34. A method for the treatment of a cancer in a patient, comprising administering to the patient a composition of claim 32.
35. An isolated polypeptide comprising an amino acid sequence of any one of SEQ ID NOs:454-455.