Substitute Form PTO 1390 US. Department of Commerce Patent and Trademark Office
`
`Attorney Docket Number:
`
`TRANSMITTAL LETTER To THE UNITED STATES
`DESIGNATED/ELECTED OFFICE (DO/EO/US)
`CONCERNING A FILING UNDER 35 U.S.C. § 371
`INTERNATIONAL APPLICATION NUMBER
`INTERNATIONAL FILING DATE
`
`PCT/CA2006/002009
`
`J December 11, 2006
`
`50245/005001
`us, Application Number;
`Not Yet Assigned
`PRIORITY DATE CLAIMED
`
`December9, 2005
`
`1 CONTAINER SYSTEM FOR RELEASABLY STORING A SUBSTANCE
`TITLE OF INVENTION:
`I Muir et al.
`APPLICANTS FOR DO/EO/US:
`Applicant herewith submits to the United States Designated/Elected Office (DO/EO/US) the following items and other information:
`
`I2I This is a FIRST submission of items concerning a filing under 35 U.S.C. § 371.
`
`D This is a SECOND or SUBSEQUENT submission of items concerning a filing under 35 U.S.C. § 371.
`
`I2I This is an express request to begin national examination procedures (35 U.S.C. § 371(f)).
`I?! The U.S. has been elected.
`
`A copy of the International Application (35 U.S.C. § 371(c)(2)).
`III a. is transmitted herewith (required only if not transmitted by the International Bureau).
`D b. has been transmitted by the International Bureau.
`in C. Is not required, as the application was filed with the United States Receiving Office (R0/US).
`An English language translation of the International Application into English (35 U.S.C. § 371(c)(2)).
`E! a. is transmitted herewith.
`CI b. has been previously submitted under 35 U.S.C. 154(dx4).
`Amendments to the claims of the International Application under PCT Article 19 (35 U.S.C. § 371(c)(3)).
`D a. are transmitted herewith (required only if not transmitted by the International Bureau).
`I3 b. have been transmitted by the International Bureau.
`U c. have not been made; however, the time limit for making such amendments has NOT expired.
`IZI d. have not been made and will not be made.
`
`D An English language translation of the amendments to the claims under PCT Article 19 (35 U.S.C. § 371(c)(3)).
`
`D An oath or declaration of the inventors (35 U.S.C. § 371(c)(4)).
`
`III An English language translation of the annexes to the International Preliminary Examination Report under PCT Article
`36 (35 U.S.C. §371 (c)(5).
`
`‘
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`D An Information Disclosure Statement under 37 C.F.R. §§ 1.97 and 1.98.
`
`El An assignment for recording. A separate cover sheet in compliance with 37 C.F.R. §§ 3.28 and 3.31 is included.
`
`[21 A preliminary amendment.
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`II A substitute specification.
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`U A power of attorney and/or change of address letter.
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`In Request for Deferred Examination.
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`E Application Data Sheet.
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`IzI Other items or information: International Search Report and Written Opinion for PCT/CA2006/002009
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`1.
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`2 3 4
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`5
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`16.
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`17.
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`18.
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`ANCESTRY EX. 1002
`ANCESTRY EX. 1002
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`1
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`19.
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`izi The following fees are submitted:
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`Basic National Stage Fee: $310
`
`National Stage Search Fee
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`$310.00
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`$410-00
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`if the written opinion prepared by ISA/US or the international pre_liminary_ _
`examination report prepared by IPEA/US indicates all claims satisfy pl'OVlSlOl'lS of
`PCT Article 33(1)-(4): $0
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`Search fee (37 C.F.R. § 1.445(a)(2)) has been paid on the international
`application to the USPTO as an International Search Authority: $100
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`International Search Report prepared by an ISA other than the US and provided to
`the Office or previously communicated to the US by the IB: $410
`All other situations: $510
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`National Stage Examination Fee
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`$210.00
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`Ifthe written opinion prepared by ISA/US or the international preliminary
`examination report prepared by IPEA/US indicates all claims satisfy provisions of
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`All other situations: $210
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`Surcharge of $1 30 for furnishing any of the search fee, examination fee, or the
`oath or declaration after the date of commencement of the national stage (37
`C.F.R. § 1.492(h)).
`CLAIMS
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`NUMBER FILED
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`NUMBER EXTRA
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`RATE
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`$130.00
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`$1750.00
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`$0.00
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`$370.00
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`Total claims
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`55 — 20 =
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`Independent claims
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`2 - 3 =
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`35
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`0
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`Multiple dependent claims (if applicable)
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`X $50
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`x $210
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`+ $370
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`Application Size Fee: Additional fee for specification and drawings in paper over
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`TOTAL OF ABOVE CALCULATIONS =
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`$3180.00
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`IZI d. The Commissioner is hereby authorized to charge any additional fees which may be required, or credit any
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`NOTE: Where an appropriate time limit under 37 C.F.R. §§ 1.494 or 1.495 has not been met, a petition to revive (37 C.F.R. §
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`SEND ALL CORRESPONDENCE TO:
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`Clark & Elbing LLP
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`Facsimile: 617-428-7045
`Customer No.: 21559
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`

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`ATTORNEY DOCKET NO. 50245/005001
`
`PATENT
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant:
`
`Muir et al.
`
`Confirmation No.: Not Yet Assigned
`
`Serial No.:
`
`Not Yet Assigned
`
`Art Unit:
`
`Not Yet Assigned
`
`Filed:
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`June 9, 2008
`
`Examiner:
`
`Not Yet Assigned
`
`Customer No.2
`
`2 1 5 59
`
`Title:
`
`CONTAINER SYSTEM FOR RELEASABLY STORING A SUBSTANCE
`
`Mail Stop Amendment
`Commissioner for Patents
`
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
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`PRELIMINARY AMENDIVIENT
`
`Prior to examination of the aboVe—captioned application, kindly amend the
`
`application as follows.
`
`3
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`

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`AIVJENDMENTS TO THE SPECIFICATION
`
`On page 3 (line 3) of PCT/CA2006/002009 (W0 2007/068094 A2; copy
`
`enclosed), please amend the specification as follows:
`
`This application is the U.S. National Stage of International Application No.
`
`PCT/CAZOO6/002009, filed December 11 2006 which in turn claims the benefit of Qlhis
`
` United States Application Serial No. 60/748,977 filed on
`
`December 9, 2005, the contents of which are hereby incorporated by reference in its
`
`entirety.
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`4
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`

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`AMENDMENTS TO THE CLAIMS
`
`1. (Original) 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; and
`
`b) a lid configured to removably 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.
`
`2. (Currently amended) The container system aeeerdingete gt;claim l 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. (Currently amended) The container system%% of claim 1elaims—l
`
`5
`
`

`
`er——2, wherein said reservoir is configured to retain about 1 1nl to about 4 1nl of said
`
`substance.
`
`4. (Currently amended) The container systema of claim 1elaims—l—~
`
`3, wherein said pierceable membrane is inert.
`
`5. (Currently amended) The container system%% of claim lelaims—l-
`
`4, wherein said pierceable membrane remains intact and pierceable at temperatures of
`
`from about —80°C to about 70°C.
`
`6. (Currently amended) The container system of claim 1 elai1—ns—l—~—
`
`5, 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. (Currently amended) The container system aeeerdingte 9:claim 1, wherein the width
`
`of said first end is approximately equivalent to the width of said second end.
`
`8. (Currently amended) The container system aeeerding—te 9__f claim 1, wherein said first
`
`end is generally wider than said second end.
`
`6
`
`

`
`9. (Currently amended) The containerw of claim 1 elainas—l—-
`
`8, wherein said chamber is configured to receive about 1 ml to about 16 ml of said
`
`sample.
`
`10. (Currently amended) The container system aeeerding—te _o_f_claim 9, wherein said
`
`chamber is configured to receive about 1 ml to about 4 ml of said sample.
`
`1 1. (Currently amended) The container system%% of claim lelaiaaas—l—-
`
`4:9, wherein the said piercing member extends from a base surface of said chamber.
`
`12. (Currently amended) The container system aeeerdingte oiclaim 11, wherein said
`
`piercing member extends approximately perpendicularly from said base.
`
`13. (Currently amended) The container system aeeordingte _Q_f_claim 11, wherein said
`
`piercing member is angled inwardly or outwardly toward said first open end of said Vial.
`
`14. (Currently amended) The container system%% of claim 1 elain=rs——l—
`
`——l—?+, 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.
`
`7
`
`

`
`15. (Currently amended) The container system aeeereling-to gficlaim 14, wherein said
`
`side wall further includes a second cutting edge.
`
`16. (Currently amended) The container system%% of claim 1 e—laims—1~
`
`~15, wherein said Vial comprises a plurality of piercing members.
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`17. (Currently amended) The container system according-to gficlaim 16, wherein said
`
`Vial comprises three piercing members.
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`18. (Currently amended) The container system aeeerdingée gficlaim 16, wherein said
`
`Vial comprises two piercing members.
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`19. (Currently amended) The container systema of claim 1—elaims~1—
`
`——1—8, 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.
`
`8
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`

`
`20. (Currently amended) The container system aeeerdingto _Qf_claim 19, 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 said piercing position.
`
`21. (Currently amended) The container system%e of claim 1 elai1=ns—l
`
`~29, wherein said vial and said lid are sized for shipping in both an unattached state and
`
`an attached state.
`
`22. (Original) A container system for releasably storing a substance, comprising:
`
`a) a vial comprising a chamber for retaining a sample
`
`b) a lid comprising a reservoir for holding the substance, and a pierceable
`
`membrane sealing the substance within said reservoir; and
`
`c) a funnel comprising a first open end for receiving said sample, a piercing
`
`member and a channel extending from said first open end to a second open end and being
`
`in fluid communication with said chamber, said funnel being removably attachable to said
`
`lid at said first open end and releasably or permanently attached to said Vial at said second
`
`end,
`
`wherein, when said system is closed by removable attachment of said lid to said
`
`funnel, said system is movable to a piercing position in which the piercing member
`
`disrupts the pierceable membrane to allow fluid communication between said reservoir
`
`9
`
`

`
`and said chamber, Via said channel, wherein the chamber is sealed against leakage to the
`
`outside of the container system in the piercing position.
`
`23. (Currently amended) The container systema o_f_claim 22 wherein said lid
`
`comprises a wall defining all or a portion of the perimeter of said reservoir and including
`
`a sealing surface for sealingly attaching said pierceable membrane;
`
`24. (Currently amended) The container system%e% of claim 22elais€1s
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`2—2—er%3, wherein said reservoir is configured to retain about 1 ml to about 4 ml of said
`
`substance.
`
`25. (Currently amended) The container system%e% of claim 22—elaims
`
`22-~24, wherein said pierceable membrane is inert.
`
`26. (Currently amended) The container system%% of claim 22elai+ns
`
`—22~—2§, wherein said pierceable membrane maintains intact and pierceable at
`
`temperatures of from about -80°C to about 70°C.
`
`10
`
`10
`
`

`
`27. (Currently amended) The container system of claim 22elai1ns
`
`22———26, wherein said pierceable membrane is sealingly attached to said sealing surface by
`
`an adhesive, a heat-sealing treatment, a fastener, or any combinations thereof.
`
`28. (Currently amended) The container systema% of claim 22elaims
`
`22~—24, wherein said piercing member extends from an interior surface of said funnel.
`
`29. (Currently amended) The container system aeeordingte 9_£_claim 28, wherein said
`
`piercing member is angled inwardly or outwardly toward said first open end of said
`
`funnel.
`
`30. (Currently amended) The container system%% of claim 22elai1ns
`
`2—2-29, 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.
`
`31. (Currently amended) The container system according-to _Q_f_clai1n 30, wherein said
`
`side wall includes a second cutting edge.
`
`11
`
`11
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`

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`32. (Currently amended) The container systema of ehnns
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`2%———3l, wherein said funnel comprises a plurality of piercing members.
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`33. (Currently amended) The container system aeeerdingto _o_f_claim 32, wherein said
`
`funnel comprises three piercing members.
`
`34. (Currently amended) The container system aeeerelingte o_flclaim 33, wherein said
`
`funnel comprises two piercing members.
`
`35. (Currently amended) The container system% of claim 22elaims
`
`«l—l—-34, wherein said system comprises sealing means for sealing said chamber against
`
`leakage to the outside of said container system.
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`36. (Currently amended) The container system aeeerdingto iclaim 35, wherein said
`
`sealing means comprises a sealing wall about the interior circumference of said lid that
`
`sealingly engages a surface of said funnel when the system is in the piercing position.
`
`37. (Currently amended) The container system%% of claim 22elaims
`
`22~———36, wherein said Vial is releasably attached to said funnel and sized for attachment to
`
`a cap when released from said funnel.
`
`10
`
`12
`
`12
`
`

`
`38. (Currently amended) The container system%w of claim 22elaiH1s
`
`2-2——3%Z, wherein said vial is configured for use in standard laboratory equipment.
`
`39. (Currently amended) The container system aeeordmgto oiclaim 38, wherein said
`
`Vial has dimensions that conforms with industry-standard dimensions for a blood
`
`collection tube.
`
`40. (Currently amended) The container system aeeordingte 9_f_claim 38-95-39, wherein
`
`said vial is a T501 tube.
`
`41. (Currently amended) The container system ofclai1n 22—elaims
`
`2—2———4(i}, wherein said chamber is sized to hold about 1 ml to about 16 ml.
`
`42. (Currently amended) The container system% of claims 4-441
`
`Q, wherein said substance is a composition for the stabilization and recovery of a nucleic
`
`acid from a biological sample.
`
`43. (Currently amended) The container system aeeer~elifig—te o_f_claim 42, wherein said
`
`nucleic acid is DNA or RNA.
`
`11
`
`13
`
`13
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`

`
`44. (Currently amended) A method of combining a substance with a biological sample,
`
`comprising:
`
`(a) providing am;container system ofclai1n 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.
`
`45. (Currently amended) A method of combining a substance with a biological sample,
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`comprising:
`
`(a) providing a—tl1_e_container system of claim 22 elaims%—2——4
`
`(b) providing the sample to the chamber in the vial through said funnel; and
`
`(c) closing said container system by removably attaching said lid to said first open
`
`end of said funnel; and
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`(d) piercing said membrane to release said substance into said chamber by moving
`
`said system to said piercing position.
`
`12
`
`14
`
`14
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`

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`46. (Currently amended) The method aeeerdingte gf_claim 44 or 45, wherein the
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`substance is a nucleic acid preserving substance.
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`47. (Currently amended) The method of claim 44 —46or 45,
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`wherein the sample is a biological sample.
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`48. (Currently amended) The method of claim 44—49Z or 45, for
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`archiving the sample.
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`49. (Currently amended) A kit for sample collection and storage, comprising:
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`a) a container system%% of elaims—l—te4—3+ claim 1 or 22; and
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`b) instructions for the use thereof.
`
`50. (Cancelled)
`
`13
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`15
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`15
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`

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`REMARKS
`
`If there are any charges or any credits, please apply them to Deposit Account
`
`No. 03-2095.
`
`Respectfully submitted,
`
` Date:
` M1chae1 J.
`
`lflzg
`
`el lveau, Ph.D.
`
`Reg.
`
`. 52,608
`
`Clark & Elbing LLP
`101 Federal Street
`
`Boston, MA 02110
`
`Telephone: 617-428-0200
`Facsimile: 617-428-7045
`
`14
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`16
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`16
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`(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization In H \ ‘
`
`-'
`
`1
`
`International Bureau
`
`(43) International Publication Date HllllIlllllllllIllllllilllIIIIIIIIIHIIIlllllllllllIllllllllllllllllllllllllllllflllllllllllll
`
`(10) International Publication Number
`WO 2007/068094 A1 21 June 2007 (21.06.2007)
`
`(51) International Patent Classification:
`A6lB 5/00 (2006.01)
`B01L 3/14 (2006.01)
`A6lB 5/15 (2006.01)
`B65D 47/36 (2006.01)
`A61] 1/05 (2006.01)
`B65D 81/32 (2006.01)
`
`(21) International Application Number:
`PCT/CA2006/002009
`
`(22) International Filing Date:
`11 December 2006 (11.12.2006)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`60/748,977
`
`9 December 2005 (09.12.2005) US
`
`(71) Applicant (for all designated States except US): DNA
`GENOTEK INC. [CA/CA]; 29 Camelot Dr., Unit 200,
`Ottawa, Ontario K2G SW6 (CA).
`
`(72) Inventors; and
`(75) Inventors/Applicants (for US only): MUIR, Rod
`[CA/CA]; Box 303, 10361 Country Road 3, South Moun~
`tain, Ontario KOE 1W0 (CA). KIRKLAND, Derek
`
`(74)
`
`(81)
`
`[CA/CA]; 57 Muskoka Road, Chelsea, Quebec I9B 2E8
`(CA). CURRY, Ian [CA/CA]; 8 VV11dacre Lane, Kanata,
`Ontario KZK 1X7 (CA). SUNSTRUM, Roy [CA/CA];
`PO. Box 1181, 25 Underhill Crescent, Richmond, Ontario
`K0A 2Z0 (CA). LEM, Paul [CA/CA]; 302445 York
`Street, Ottawa, Ontario KIN 8Y3 (CA).
`
`Agents: OSLER, HOSKIN & HARCOURT LLP et a1.;
`Suite 1500, 50 O’Connor Street, Ottawa, Ontario K11’ 6L2
`(CA).
`
`Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN,
`CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI,
`GB, GD, GE, GH, GM, GT, }H\I, HR, HU, ID, IL, IN, IS,
`JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS,
`LT, LU, LV, LY, MA, ND), MG, MK, MN, MW, MX, MY,
`MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS,
`RU, SC, SD, SE, SG, SK, SL, SM, SV, SY, TJ, TM, TN,
`TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
`
`(84)
`
`Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`
`[Continued on next page]
`
`
`(54) Title: CONTAINER SYSTEM FOR RELEASABLY STORING A SUBSTANCE
`
`(57) Abstract: The present invention provides
`a container
`system for
`releasabiy storing a
`substance.
`The container system includes a
`vial having a sample storage chamber and a
`piercing member for piercing a membrane in the
`lid, which membrane seals a substance within
`a reservoir in the lid until
`the membrane is
`pierced by the piercing member. The container
`system optionally includes a funnel. There is
`also provided a method and kit for use of such a
`container system.
`
`
`
`WO2007/068094A1HllllIlllllllllIlllllllllllllllllllllllllllIllIlillllllllllllllllllllllIIIIIIIIIIIIIIHIIHIII
`
`17
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`17
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`

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`WO 2007/068094 Al
`
`IlllllIlllllliIIlllllllllllllllllllilllllIlillllllllIlllllllllllllllllllllllIlllllllllllllillll
`
`Published:
`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM,
`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), — with international search report
`European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI,
`FR, GB, GR, HU, IE, IS, IT, LT, LU, LV, MC, NL, PL, PT,
`RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA,
`GN, GQ, GVJ, NIL, MR, NE, SN, TD, TG).
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`Fortw0~letter codes and other abbreviations, refer to the "Guid-
`ance Notes on Codes andAbbreviations" appearing at the begin—
`ning of each regular issue ofthe PCT Gazette.
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`WO 2007/068094
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`PCT/CA2006/002009
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`CONTAINER SYSTEM FOR RELEASABLY STORING ACE
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`RELATED APPLICATION
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`This application claims priority to United States Application Serial No.
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`60/748,977 filed on December 9, 2005, the contents of which are hereby incorporated by
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`reference in its entirety.
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`FIELD OF THE INVENTION
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`The field of the invention generally relates to a container system for releasably
`storing a substance.
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`‘ BACKGROUND
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`It is often desirable to store a. substance, such as a liquid, solid, gas,.mixtures thereof, .
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`or the like, in a container prior to mixing the contents of the container with another material.
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`For example, it may be desirable to package and store a compound, or compounds, in a
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`container for shipping and/or safe storage and handling, prior to combining the compound(s)
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`It may be desirable to package and store a toxic compound in a
`with another material.
`container, prior to combining such a toxic compound with a detoxifying material. As well,
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`it is often desirable to keep a concentrated active ingredient separate from a diluent until
`immediately prior to use.
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`Moreover, it maybe desirable to store and/or ship diagnostic andlor nucleic acid
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`preserving compositions prior to combining such a substance with a biological sample.
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`Additionally, it may be desirable to keep a substance isolated from a donor until the
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`donor‘s biological sample has been collected. This will help to prevent the donor from
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`accidentally ingesting or spilling the substance.
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`It may also be desirable to inactivate pathogens/infectious particles in a biological
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`sample by combining it with a stored substance prior to storage and/or shipping and/or
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`handling of the sample.
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`It may also be desirable to store and/or ship diagnostic and/or nucleic acid preserving
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`compositions after combining such a substance with a biological sample.
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`There are a variety of containers for holding substances‘ separately in such a manner
`that a user may open a closure to combine the substances. Typically these containers are
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`double compartment systems in which substances are stored separately and substances are
`combined by removal of the container closures by auser.
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`International PCT application W0 2003/104251 describes a container for collecting .
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`a biological sample from a subject, and subsequently mixing the collected sample with a
`' composition intended to stabilize, preserve, or-facilitate the recovery of components of the
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`sample. This container has a first region for collecting a biological sample, a second region
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`~ containing a composition for preserving a nucleic acid, and a barrier between the first region
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`_ and the second region, which when in a closed position, maintains the sample and
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`composition separate. The exemplified barrier of WO 2003/104251 is a pivoting partition.
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`Attachment of a lid to the container forces the barrier to pivot from its original closed
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`position spanning the container and thereby separating the first region and the second
`region, to an open position in which both regions are exposed to each other and contact
`between the composition containedlin one region space and the biological sample contained
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`in the other region is allowed. A drawback of this container is that it includes multiple parts
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`(e.g.,
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`lid, vial, disk, rod, rod holder), which increases the cost of manufacture of the
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`container. Additionally, because the disk is held in place by friction fit, there must be a high
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`degree of precision for the manufticture of the components of the container.
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`There remains a need for an improved container system for releasably and reliably
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`storing a substance.
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`This background information is provided for the purpose of making known
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`information believed by the applicant to be of possible relevance to the present invention.
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`No admission is necessarily intended, nor should be construed, that any of the preceding
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`information constitutes prior art against the present invention.
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`WO 2007/068094
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`PCT/CA2006/002009
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`. 3 .
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`SUMMARY OF THE INVENTION
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`The present invention generally relates to a container system for releasably storing a
`substance.
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`In accordance with one aspect of the present invention. there is provided a container
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`system for releasably ‘storing a substance, comprising: a) a vial comprising a first open end,
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`for receiving a sample, a second end comprising a sample storage chamber and a piercing
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`member; and b) a lid configured to removably engage said vial, said lid comprising a
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`reservoir for holding the substance, and a pierccable membrane sealing the substance within-
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`said reservoir, wherein, when said system is closed by removable engagement of said vial
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`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
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`reservoir and said chamber, wherein the chamber is sealed against leakage to the outside of
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`the container system in the piercing position.
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`In ‘accordance with another aspect of the present invention, there is provided a
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`container system for releasably storing a substance, comprising: a) a vial comprising a
`chamber for retaining a sample b) a lid comprising a reservoir for holding the substance, and i
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`a picrceable membrane sealing the substance within said reservoir; and c) a funnel
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`comprising a first open end for receiving said sample, a piercing member and a channel
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`extending fiom said first open end to a second open end and being in fluid communication
`with said chamber, said funnel being removably attachable to said lid at said first open end
`and releasably or permanently attached to said vial at said second end, wherein, when said
`system is closed by removable attachmentof said lid to said funnel, said system is movable
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`to a piercing position in which the piercing member disrupts the pierceable membrane to
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`allow fluid communication between said reservoir and said chamber, via said channel,
`wherein the chamber is sealed against leakage to the outside of the container system in the
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`piercing position.
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`In accordance with another aspect of the present invention, there is provided a
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`method of combining a substance with a biological sample, comprising: {a) providing a
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`container system as described herein; (b) providing the sample to the chamber in the vial;
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`and (c) closing said container system by removable attachment of the lid to the vial or
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`funnel; and (d) piercing the membrane to release said substance into said chamber by
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`moving the system to said piercing position.
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`In accordance with another aspect of the present invention thereis provided akit for
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`releasably storing a substance comprising: a) a container system as described herein; and b)
`instructions for the use thereof.
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`BRIEF DESCRIPTION OF THE FIGURES
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`Figure 1 is a cross-sectional view of a container system in accordance with one embodiment
`of the present invention, showing the lid and vial attached;
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`Figure 2 is a perspective view of the‘ interior of the lid ‘of the container system depicted in
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`Figure 1;
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`Figure 3 is a perspective view of the interior of the vial of the container system depicted in
`‘Figure-. 1;
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`Figure 4 is a perspective View of a container system in accordance with one embodiment of
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`the present invention;
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`Iiigure 5 is a top view of the container system depicted in Figure 4;
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`Figure 6 is a side view of the container system depicted
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`Figure 4;
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`Figure 7 is a side view of the container system depicted in Figure 4;
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`Figure 8 is a bottom view ofthe container system depicted in Figure 4;
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`Figure 9 is a cross-sectional View of the container system of Figure 4 taken along line A-A
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`in Figure 5;
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`Figure 10 is a top perspective view of the container system depicted in Figure 4 showing the
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`lid and vial separated;
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`Figure 11 is a bottom perspective view of the container system depicted in Figure 4 showing
`the lid and vial separated;
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`Figure 12 is a side perspective view a container system in accordance with one embodiment
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`of the present invention;
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`Figure 13 is a top view ofthe container system depicted in Figure i2;
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`Figure 14 is a bottom View of the container system depicted in Figure 12;
`15 is a side view ofthe containersystem depicted inFigure 12;
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`Figure 16 is a cross-sectional view of the container system of Figure 12 taken along line B—B
`in Figure 15;
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`Figure 17 is a side perspective view ofthe container system depicted in Figure 12;
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`Figure 18 -is a top perspective view of the container system depicted in Figure 12, showing
`the lid and funnel separated;
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`Figure 19 is a bottom side perspective view of the container system depicted in Figure 12,
`showing the lid and funnel separated;
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`Figure 20 a side view ofthe vial and cap ofthe container system depicted in Figure 9;
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`Figure 21 is a side view of the container system depicted in Figure 12, showing the lid,
`funnel, and vial separated;
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`Figure 22 is a side perspective view a container system in accordance with one embodiment
`of the present invention;
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`Figure 23 is a top perspective view of the vial portion of the container system depicted in
`Figure 22, showing the vial; and
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`Figure 24 is a cross-sectional view of the lid of the container system depicted in Figure 22.
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`The numbers in bold face ‘type serve to identify the component parts that are
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`described and referred to in relation to the drawings depicting various embodiments of the
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`present invention. It should be noted that in describing various embodiments of the present
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`invention, the same reference numerals have been used to identify the same or similar
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`elements. Moreover, for the sake of simplicity, parts have been omitted from some figures
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`of the drawings.
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`DETAILED DESCRIPTION OF THE INVENTION
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`As will be discussed in more detail below, the present invention provides a container
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`system for releasahly storing a substance.
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`The container system of the present invention has fewer parts and, thus, is less
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`expensive and/or easier to manufacture,
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`than previous containers. Additionally,
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`the
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`manufacturing tolerances can be less precise for the container system of the present
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`invention, as compared to previous containers having separable compartments. Again, this
`reduces manufacturing cost, and makes accidental disruption of a sealed substance less
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`likely. Additionally, in one example of the present invention, the container system includes a
`removable vial which is suitable for subsequent processing of samples and/or for use in
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`robotic systems.
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`The container system of the present invention comprises a vial and a lid. Optionally,
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`the container system additionally comprises a funnel that is permanently or removably
`attached to the vial and that sealingly engages the lid.
`‘The lid is configured to store a
`substance, and subsequently release the substance fiom the l