Product authentication

• US 20070012784A1
• Filed: 06/20/2006
• Published: 01/18/2007
• Est. Priority Date: 06/20/2005
• Status: Active Grant

• Current Assignee: Authentiform Technologies, LLC
• Original Assignee: Authentiform Technologies, LLC
• Inventors: Mercolino, Thomas
• Granted Patent: US 7,874,489 B2
• Time in Patent Office: Days
• US Class Current: 235/491
• CPC Class Codes: G01N 2021/8427 Coatings
• CPC Class Codes: G01N 21/643 non-biological material
• CPC Class Codes: G01N 21/8422 Investigating thin films, e.g. matrix isolation method
• CPC Class Codes: G09F 13/20 with luminescent surfaces or parts luminescent compositions C09K11/00; light sources using luminescence F21K2/00
• CPC Class Codes: G09F 3/00 Labels, tag tickets, or similar identification or indication means medals or badges A44C3/00; making labels B31D1/02; sheets temporarily attached together B42F; labelling B65C; labels on record carriers G11B23/38, G11B23/40; Seals; Postage or like stamps

Abstract

The present invention provides methods, reagents, and apparatus for authenticating products. Methods of the invention are easy to implement but difficult to replicate, simulate, alter, transpose, or tamper with. In particular, the present invention relates to a product authentication code defined by a signature array of a population of entities, and its use thereof.

Claims

1. A method of marking a product for product authentication, comprising the steps of:

a) associating a population of entities with the product, wherein the population comprises at least two distinct clusters of entities having detectable counts or relative counts of entities per cluster; and

b) assigning a signature array of the population of entities to the product as a product authentication code, wherein the signature array comprises information about the counts or relative counts of entities of at least two distinct clusters of entities within the population.

2. The method of claim 1 further comprising a step of correlating the count or relative count of entities of one or more clusters that form the population of entities with a specific piece of information about the product.

3. The method of claim 2 wherein the specific piece of information about the product is selected from the amount, concentration, or presence or absence of a product component.

4. The method of claim 1, wherein each of the at least two distinct clusters of entities has one or more discretely measurable common properties that are shared by entities within said cluster, but not by entities within any other cluster.

5. The method of claim 4, wherein the one or more discretely measurable common properties are properties of one or more tags associated with the entities.

6. The method of claim 5, wherein the one or more tags associated with the entities is selected from the group consisting of:

colors, fluorescent dyes, ultraviolet radiation dyes, luminescent compositions, printed symbols, microparticles, haptens, nucleotides, polypeptides, scents, and a combination thereof.

7. The method of claim 4, wherein the one or more discretely measurable properties of the entities are the size of the entities, the style of the entities, or the shape of the entities.

8. The method of claim 1, wherein the population of entities comprises microparticles.

9. The method of claim 8, wherein the microparticles are labeled with at least two discretely measurable fluorescent dyes.

10. The method of claim 9, wherein the at least two discretely measurable fluorescent dyes are present on the same microparticle.

11. The method of claim 8, wherein the microparticles are labeled with a fluorescent dye in at least two detectable different intensity levels.

12. The method of claim 1, wherein the population of entities comprises printed symbols.

13. The method of claim 1, wherein the population of entities comprises one or more types of entities selected from the group consisting of microparticles, printed symbols, nucleic acid molecules, peptides, polypeptides, hapten, or a combination thereof.

14. The method of claim 1, wherein during the step of associating a population of entities with the product, the population is associated with the product by incorporation into the composition of the product.

15. The method of claim 1, wherein during the step of associating a population of entities with the product, the population is associated with the product by incorporation on or near the surface of the product.

16. The method of claim 1, wherein during the step of associating a population of entities with the product, the population is associated with the product by being present in the product container, packaging, labeling, other medium that is associated with the product, or a combination thereof.

17. The method of claim 1, wherein the product is a pharmaceutical product.

18. The method of claim 1, wherein the entities are non-toxic in amounts used.

19. The method of claim 17, wherein the pharmaceutical product is a liquid pharmaceutical product.

20. The method of claim 17, wherein the product is a solid pharmaceutical product.

21. A coded product comprising a product and a product authentication code wherein the product authentication code is encoded by a signature array of a population of entities associated with the product, wherein the signature array comprises information about the counts or relative counts of entities of at least two distinct clusters of entities within the population.

22. The product of claim 21 being a pharmaceutical product.

23. The product of claim 22 being a solid pharmaceutical product.

24. The product of claim 22 being a semi-solid pharmaceutical product.

25. The product of claim 22 being a liquid pharmaceutical product.

26. The product of claim 22 being an injectable pharmaceutical product.

27. The product of claim 21 being selected from the group consisting of recordings, textiles, leather goods, and automotive components.

28. The product of claim 21 further comprising an additional product authentication means.

29. The product of claim 28 wherein the additional product authentication means uses a radio frequency identification (RFID) tag, a spectroscopic ink, a hologram, a reflective paper, a laser etched paper, or a bar code

30. The product of claim 28 wherein the additional product authentication means uses a radio frequency identification tag.

31. An improvement to a product, wherein the improvement is a product authentication code that is encoded by a signature array of a population of entities associated with the product, wherein the signature array comprises information about the counts or relative counts of entities of at least two distinct clusters of entities within the population.

32. A method of determining a signature array of a population of entities, comprising the steps of:

a) classifying entities within the population into at least two distinct clusters of entities;

b) determining the counts or relative counts of entities within each of the at least two distinct clusters of entities; and

c) combining the information about the counts or relative counts of entities of the at least two distinct clusters of entities into an array.

33. The method of claim 32, further comprising a step of collecting the population of entities prior to the step of measurement.

34. The method of claim 32, wherein a flow cytometer is used.

35. The method of claim 32, wherein a microscope is used.

36. The method of claim 32, wherein a particle-counter is used.

37. The method of claim 36, wherein the particle-counter is handheld.

38. A method of authenticating a product, comprising the steps of:

a) associating a population of entities with the product, wherein the population comprises at least two distinct clusters of entities having detectable counts or relative counts of entities per cluster;

b) assigning a signature array of the population of entities to the product as a product authentication code, wherein the signature array comprises information about the counts or relative counts of entities of at least two distinct clusters of entities within the population;

wherein information about the signature array and the product authentication code is recorded;

c) analyzing the product to obtain a measured signature array of the population of entities associated with the product;

d) comparing the measured signature array with that which is expected based on the recorded information; and

e) accepting the product as authenticate when the measured signature array matches that which is expected.

39. The method of claim 38, wherein the product is a pharmaceutical product.

40. The method of claim 38, wherein during the step b) of claim 38, the information about the signature array and the product authentication code is recorded in a database.

41. A method for quality control and release of products from a manufacturing process, comprising the steps of:

a) associating a population of entities with a product during the manufacturing process, wherein the population of entities comprises at least two distinct clusters of entities having detectable counts or relative counts of entities per cluster, wherein a signature array that comprises information about the counts or relative counts of entities of the at least two distinct clusters of entities is recorded;

b) analyzing the product to obtain a measured signature array of the population of entities associated with the product;

c) comparing the measured signature array with that which is expected based on the recorded information; and

d) releasing products manufactured by the manufacturing process when the measured signature array matches that which is expected.

42. The method of claim 41, wherein the product is a pharmaceutical product.

43. The method of claim 41, wherein during the step a) of claim 41, the information about the signature array and the product authentication code is recorded in a database.

44. The method of claim 41, wherein during the step a) of claim 41, the population of entities is associated with an active ingredient of the product during the manufacturing process.

45. The method of claim 41, wherein during the step a) of claim 41, at least one cluster of the population of entities is associated with an active ingredient of the product during the manufacturing process.

46. A product manufactured by a process of manufacturing comprising the steps of:

a) incorporating a population of entities into a product during the manufacturing process, wherein the population of entities comprises at least two distinct clusters of entities having detectable counts or relative counts of entities per cluster, wherein a signature array that comprises information about the counts or relative counts of entities of the at least two distinct clusters of entities is recorded;

b) analyzing the product to obtain a measured signature array of the population of entities incorporated into the product;

c) comparing the measured signature array with that which is expected based on the recorded information; and

d) releasing products manufactured by the manufacturing process when the measured signature array matches that which is expected.

47. The product of claim 46 being a pharmaceutical product.