Designation
`
`‘381 claim element or limitation
`
`[1.P]
`
`[1.1]
`[1.2]
`[1.3]
`[1.4]
`[1.5]
`
`[1.6]
`
`[1.7]
`[1.8]
`
`[1.9]
`
`[1.10]
`
`1. A container system for releasably storing a substance,
`comprising:
`a) a vial comprising
` a first open end for receiving a sample,
` a second end comprising a sample storage chamber and
` a piercing member,
`wherein said piercing member comprises a side
`wall, a first cutting edge extending from a first
`pointed corner to a second corner that defines the
`intersection between said cutting edge and said side
`wall; and
`b) a lid configured to removable engage said vial, said lid
`comprising
` a reservoir for holding the substance, and
` a pierceable membrane sealing the substance within said
`reservoir,
`wherein, when said system is closed by removable engagement of
`said vial with said lid, said vial and said lid are movable
`to a piercing position in which the piercing member
`disrupts the pierceable membrane to allow fluid
`communication between said reservoir and said chamber,
`wherein the chamber is sealed against leakage to the outside of the
`container system in the piercing position.
`
`ANCESTRY EX. 1019
`
`1
`
`
`
`‘381 claim element or limitation
`
`[1.P]
`
`[1.1]
`[1.2]
`[1.3]
`[1.4]
`[1.5]
`
`[1.6]
`
`[1.7]
`[1.8]
`
`[1.9]
`
`[1.10]
`
`1. A container system for releasably storing a substance,
`comprising:
`a) a vial comprising
` a first open end for receiving a sample,
` a second end comprising a sample storage chamber and
` a piercing member,
`wherein said piercing member comprises a side
`wall, a first cutting edge extending from a first
`pointed corner to a second corner that defines the
`intersection between said cutting edge and said side
`wall; and
`b) a lid configured to removable engage said vial, said lid
`comprising
` a reservoir for holding the substance, and
` a pierceable membrane sealing the substance within said
`reservoir,
`wherein, when said system is closed by removable engagement of
`said vial with said lid, said vial and said lid are movable
`to a piercing position in which the piercing member
`disrupts the pierceable membrane to allow fluid
`communication between said reservoir and said chamber,
`wherein the chamber is sealed against leakage to the outside of the
`container system in the piercing position.
`
`ANCESTRY EX. 1019
`
`1
`
`
`
`Designation
`
`‘381 claim element or limitation
`
`[2.1]
`
`[3.1]
`
`[4.1]
`
`[5.1]
`
`[6.1]
`
`[7.1]
`
`[8.1]
`
`[9.1]
`
`[10.1]
`
`[11.1]
`
`[12.1]
`
`[13.1]
`
`2. The container system of claim 1,
`wherein said lid comprises a wall defining all or a portion of the
`perimeter of said reservoir, said wall having a sealing surface for
`sealingly attaching said pierceable membrane.
`3. The container system of claim 1,
`wherein said reservoir is configured to retain about 1 ml to about 4
`ml of said substance.
`4. The container system of claim 1,
`wherein said pierceable membrane is inert.
`5. The container system of claim 1,
`wherein said pierceable membrane remains intact and pierceable at
`temperatures of from about -80ºC. to about 70ºC.
`6. The container system of claim 1,
`wherein said pierceable membrane is sealingly attached to said
`sealing surface by an adhesive, a heat-sealing treatment, a fastener,
`or any combinations thereof.
`7. The container system of claim 1,
`wherein the width of said first end is equivalent to the width of
`said second end.
`8. The container system of claim 1,
`wherein said first end is generally wider than said second end.
`9. The container system of claim 1,
`wherein said chamber is configured to receive about 1 ml to about
`16 ml of said sample.
`10. The container system of claim 9,
`wherein said chamber is configured to receive about 1 ml to about
`4 ml of said sample.
`11. The container system of claim 1,
`wherein the said piercing member extends from a base surface of
`said chamber.
`12. The container system of claim 11,
`wherein said piercing member extends approximately
`perpendicularly from said base.
`13. The container system of claim 11,
`wherein said piercing member is angled inwardly or outwardly
`toward said first open end of said vial.
`
`2
`
`
`
`Designation
`
`‘381 claim element or limitation
`
`[14.1]
`
`[15.1]
`
`[16.1]
`
`[17.1]
`
`[18.1]
`
`[19.1]
`
`[20.1]
`
`[39.1]
`
`[40.1]
`
`[41.P]
`
`[41.1]
`[41.2]
`[41.3]
`
`[41.4]
`
`[43.1]
`
`[44.1]
`
`14. The container system of claim 1,
`wherein said side wall further includes a second cutting edge.
`15. The container system of claim 1,
`wherein said vial comprises a plurality of piercing members.
`16. The container system of claim 15,
`wherein said vial comprises three piercing members.
`17. The container system of claim 15,
`wherein said vial comprises two piercing members.
`18. The container system of claim 1,
`wherein said system comprises sealing means for sealing said
`chamber against leakage to the outside of said container system
`following movement of said container system to said piercing
`position.
`19. The container system of claim 18,
`wherein said sealing means comprises a sealing wall about the
`interior circumference of said lid that sealingly engages a surface
`of said vial when the system is in said piercing position.
`20. The container system of claim 1,
`wherein said vial and said lid are sized for shipping in both an
`unattached state and an attached state.
`39. The container system of claim 1 or 21, wherein said substance
`is a composition for the stabilization and recovery of a nucleic acid
`from a biological sample.
`40. The container system of claim 39, wherein said nucleic acid is
`DNA or RNA.
`41. A method of combining a substance with a biological sample,
`comprising:
`(a) providing the container system of claim 1;
`(b) providing the sample to the chamber in the vial; and
`(c) closing said container system by removably attaching said lid
`to said vial; and
`(d) piercing said membrane to release said substance into said
`chamber by moving said lid and said vial to said piercing position.
`43. The method of claim 41 or 42, wherein the substance is a
`nucleic acid preserving substance.
`44. The method of claim 41 or 42, wherein the sample is a
`
`3
`
`
`
`
`Designation
`
`
`[45.1]
`[46.P]
`[46.1]
`[46.2]
`[47.1]
`
`[49.1]
`
`
`
`
`‘381 claim element or limitation
`
`biological sample.
`45. The method of claim 41 or 42, for archiving the sample.
`46. A kit for sample collection and storage, comprising:
`a) a container system of claim 1 or 21; and
`b) instructions for the use thereof.
`47. The container system of claim 1, wherein the substance is a
`liquid.
`49. The container system of claim 1, additionally comprising a
`solid or semi-solid material within said vial and maintained
`separate from the substance in the reservoir of said lid until said
`pierceable membrane is disrupted.
`
`4
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