Bottles and jars – Closures – Cap type
Reexamination Certificate
2002-09-27
2004-03-09
Ackun, Jacob K. (Department: 3712)
Bottles and jars
Closures
Cap type
C215S354000, C215S341000, C215S329000, C215S044000, C215S045000
Reexamination Certificate
active
06702134
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a substantially leak-proof closure system for storing fluids under cold storage conditions, where the closure system includes a container component and a cap component which can be fitted onto the container component.
INCORPORATION BY REFERENCE
All references referred to herein are hereby incorporated by reference in their entirety. The incorporation of these references, standing alone, should not be construed as an assertion or admission by the inventors that any portion of the contents of all of these references, or any particular reference, is considered to be essential material for satisfying any national or regional statutory disclosure requirement for patent applications. Notwithstanding, the inventors reserve the right to rely upon any of such references, where appropriate, for providing material deemed essential to the claimed invention by an examining authority or court. No reference referred to herein is admitted to be prior art to the claimed invention.
BACKGROUND OF THE INVENTION
Procedures for determining the presence or absence of specific organisms or viruses in a test sample commonly rely upon nucleic acid-based probe testing. To increase the sensitivity of these tests, an amplification step is often included to increase the number of potential nucleic acid target sequences present in the test sample. During amplification, polynucleotide chains containing the target sequence or its complement are synthesized in a template-dependent manner from ribonucleoside or deoxynucleoside triphosphates using nucleotidyltransferases known as polymerases. There are many amplification procedures in common use today, including the polymerase chain reaction (PCR), Q-beta replicase, self-sustained sequence replication (
3
SR), transcription-mediated amplification (TMA), nucleic acid sequence-based amplification (NASBA), ligase chain reaction (LCR), strand displacement amplification (SDA) and loop-mediated isothermal amplification (LAMP), each of which is well known in the art. See, e.g., Mullis, “Process for Amplifying Nucleic Acid Sequences,” U.S. Pat. No. 4,683,202; Erlich et al., “Kits for Amplifying and Detecting Nucleic Acid Sequences,” U.S. Pat. No. 6,197,563; Walker et al.,
Nucleic Acids Res.,
20:1691-1696 (1992); Fahy et al., “Self-sustained Sequence Replication (3WSR): An Isothermal Transcription-Based Amplification System Alternative to PCR,”
PCR Methods and Applications,
1:25-33 (1991); Kacian et al., “Nucleic Acid Sequence Amplification Methods,” U.S. Pat. No. 5,399,491; Davey et al., “Nucleic Acid Amplification Process,” U.S. Pat. No. 5,554,517; Birkenmeyer et al., “Amplification of Target Nucleic Acids Using Gap Filling Ligase Chain Reaction,” U.S. Pat. No. 5,427,930; Marshall et al., “Amplification of RNA Sequences Using the Ligase Chain Reaction,” U.S. Pat. No. 5,686,272; Walker, “Strand Displacement Amplification,” U.S. Pat. No. 5,712,124; Notomi et al., “Process for Synthesizing Nucleic Acid,” U.S. Pat. No. 6,410,278; Dattagupta et al., “Isothermal Strand Displacement Amplification,” U.S. Pat. No. 6,214,587; and HELEN H. LEE ET AL., NUCLEIC ACID AMPLIFICATION TECHNOLOGIES: APPLICATION TO DISEASE DIAGNOSIS (1997).
Because polymerase activity is readily lost at ambient temperature, it is common to manufacture amplification kits which include polymerase-containing enzyme reagents that have been freeze-dried in formulations containing other necessary co-factors and substrates for amplification. See, e.g., Shen et al., “Stabilized Enzyme Compositions for Nucleic Acid Amplification,” U.S. Pat. No. 5,834,254. It is also common to manufacture amplification kits which include amplification reagents containing nucleoside triphosphates and/or amplification primers in freeze-dried formulations. Alternatively, these enzyme and amplification reagents can be kept in cold storage at temperatures well below 0° C. (e.g., at about −20° C.). An advantage of cold storage is that reagents can be manufactured and shipped directly on dry ice to the end user, avoiding lengthy and expensive lyophilization procedures prior to shipping, as well as time-consuming and exact reconstitution procedures by the end-user. However, storing fluid reagents in laboratory freezers is generally disfavored because these reagents, which may contain, for example, glycerol or non-ionic detergents (non-ionic detergents can be used to sequester ionic detergents in a sample solution which may solubilize target nucleic acid or interfere with enzyme function and are often used to stabilize the enzymes), tend to remain highly viscous fluids in commonly used sub-zero freezers.
As the volume of these highly viscous fluids expands under cold storage conditions, one leak theory provides that a significant meniscus forms and rises which, if high enough, can seep through the seals of conventional storage containers. Other leak theories relate to temperature fluctuations due to the repeated opening and closing of storage freezers. According to one of these theories, it is believed that the stored fluid freezes and water is removed from the frozen fluid by sublimation which settles, inter alia, in the interstices between the cap and the container. When the storage freezer is subsequently opened, the temperature within the freezer rises and the water vapor forms a condensate which freezes as the storage freezer is restored to its normal operating temperature. As the condensate freezes, it expands in the interstices between the cap and the container, thereby weakening the seal. Another of these theories provides that the stored fluid does not freeze, but the opening and closing of the storage freezer causes temperature fluctuations which lead to the formation of a condensate in the interstices between the cap and the container. Like the sublimation theory, the freezing of this condensate as the storage freezer is restored to its normal operating temperature could result in sufficient expansion between the cap and the container to create fissures which might provide an avenue of escape for fluid stored in the container.
Besides wasting expensive reagents, seepage of reagents from their storage containers is especially problematic when the reagents have been aliquoted for use in a specified number of amplification reactions in an automated instrument. (See Ammann et al., “Automated Process for Isolating and Amplifying a Target Nucleic Acid Sequence,” U.S. Pat. No. 6,335,166, for an example of an instrument for performing automated nucleic acid amplification and detection steps.) Therefore, loss of some reagent from the container could affect amplification efficiency in one or more assays.
Consequently, it would desirable to have a closure system that provides a sealing system which prevents or severely limits seepage of a stored fluid substance under cold storage conditions, especially substances which remain at least partially fluid under those cold storage conditions. Such substances may include one or more components affecting the viscosity or surface tension of the stored fluid or which contribute to freezing point depression of the stored fluid. In particular, the desired closure system would be useful for storing enzyme and/or amplification reagents for use in a nucleic acid amplification reaction, where the reagents are stored in a conventional laboratory freezer at a temperature of about −20° C. To accommodate its use in an automated instrument, the closure system should preferably be designed so that its internal volume is maximized and so that a robotic pipettor will have access to all or nearly all of the full volume of the stored fluid reagent.
SUMMARY OF THE INVENTION
The present invention meets this need by providing a substantially leak-proof closure system for storing fluids under cold temperature conditions which includes a container and a cap. The container component, which is generally cylindrical in shape, includes a side wall having inner and outer surfaces, a closed bottom end and an open top end having an annular top rim and a be
Kacian Daniel L.
Scalese Robert F.
Ackun Jacob K.
Cappellari Charles B.
Gen-Probe Incorporated
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