Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving viable micro-organism
Reexamination Certificate
2002-10-28
2004-04-20
Redding, David A. (Department: 1744)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving viable micro-organism
C435S309300, C073S864160, C422S105000
Reexamination Certificate
active
06723528
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates, in general, to inoculation storage devices and more particularly to apparatus and methods used to store and preserve the sterility of inoculation devices.
2. Description of Related Art
U.S. Pat. No. 5,330,899 to DeVaughn shows an inoculation storage assembly and method of preserving the sterility of inoculation loops and streaking needles. The DeVaughn patent discloses a storage assembly or rack having a sheet-like cover positioned across a plurality of openings to seal the cavities and to retain inoculation devices in the cavities in a sterile condition.
As the biotechnology, pharmaceutical and related industries experience unprecedented growth, laboratory research and development proportionately expands. Research precision has become increasingly important, often distinguishing a laboratory's efforts. Through research evolution, research apparatus and techniques, once thought to represent the industry standard, are continually being replaced by better, more efficient and accurate apparatus and techniques.
Typically, after a desired microorganism has been successfully incubated in a nutrient broth substance, it is necessary to colonized the micro-organism so that the particular strain can be identified, researched or be the subject of experimentation. This procedure requires extracting a predetermined quantity of the inoculant from the broth and implanting or inoculating a nutrient medium, or blood agar, so that the microorganism can be grown under more controlled conditions. Using an inoculation device having an inoculating end, which is usually either needle-shaped or a loop, an approximate quantity of the cultured broth may be withdrawn from the broth by immersing the inoculating end in the broth. Subsequently, the inoculant is spread and implanted in the nutrient rich medium (agar) by contacting the inoculating end with the nutrient. Growth is stimulated by incubating the nutrient, for example, at approximately 37 degree C. which simulates body temperature. This incubation period, depending on the rate of growth of the micro-organism which in some cases doubles every 20 minutes, is typically 24 hours. Subsequently, the colonized microorganism may be identified, studied or be the subject of experimentation.
Inoculation tools, in general, have not changed radically since the introduction of the inoculation loop and streaking needle. Earlier inoculation devices were comprised of metallic wires or needles. Often platinum or silver were used because of their high conductive resistance. Metallic inoculation devices usually require sterilization before each use so that the inoculant would not be contaminated by the growth or existence of other contaminating organisms or bacteria carried by the inoculating ends. By placing the inoculating end in an open flame, such as a Bunsen burner, until the end becomes red hot, the loop or needle could be sterilized. The research technician must then wait for the loop to air cool.
Metallic inoculating loops and needles are still in use today. One problem associated with these devices is that this technique is generally time consuming. Often, several different types of microorganism colonies are being cultured consecutively. Valuable time is expended because the inoculating end must be sterilized after contact with each different inoculant or nutrient. Thus, the technician must complete the entire sterilization cycle after each use. Furthermore, since the metallic ends are held over an open flame, the length of the inoculating device must be fairly long to prevent burning the technician. Moreover, insulated handles are often required as a precaution and for ease of handling. Storage, however, becomes problematic when the devices are too long. Finally, materials such as platinum and silver, which are used because of their high conductivity, are undesirably costly. This cost factor is particularly important if one tries to overcome the time delay problems by using multiple metallic inoculation loops or needles.
More recently, plastic inoculating devices have begun to replace metallic inoculating devices. While such plastic inoculation devices have greatly decreased manufacturing cost, sterilization has become a problem. Heat sterilization over an open flame, of course, is inappropriate because the inoculating ends would either melt or substantially deform. Therefore, the inoculation devices must be sterilized by irradiation with radio-isotopes or an electron beam, or by autoclaving before packaging. Typically, a multitude of inoculating loops and needles are sterilized and then packaged in storage BAGS, OR THROUGH ONE MANUFACTURER, Bio-Plas, Inc. of San Francisco, Calif., in a storage rack or container.
These approaches have presented their own problems. Once the bag or rack is opened, all the inoculating devices are subject to becoming contaminated with time or if they are touched. The bag or rack of inoculating devices must be used completely or there is a risk of inoculating future mediums with contaminated inoculants.
This loss of sterilization may be partially overcome by packaging the plastic inoculation devices individually and then sterilizing them. While individual packaging has been satisfactory for most uses, again, however, the loops or needles often become contaminated upon removal from the package. Moreover, removal from each individual package becomes tedious and time consuming, requiring repeated openings of individual containers. Storage also becomes problematic when these devices are amassed in bulk and individual packaging increases cost.
In U.S. Pa. No. 5,330,899 the loss of sterilization problem was overcome by packaging loops and needles in a storage rack having a frangible sheet positioned across the openings of the cavities storing the loops or needles to seal them and to retain the inoculation devices in the cavities. This technique requires the addition of the sheet-like cover to seal and retain the inoculation devices and puncturing of the cover by the inoculation gripping device for each loop or needle.
What is needed is a method and apparatus which overcomes the above and other disadvantages of known inoculation storage assemblies.
SUMMARY OF THE INVENTION
In summary, one aspect of the present invention is directed to a method of storing and dispensing an inoculation device having a sterile inoculation end and a seal carried by the inoculation device for sealing the inoculation device in a sterile cavity in a storage container or rack, comprising the steps of engaging the device, withdrawing it from the rack and optionally releasing it. The engaging step is accomplished by engaging a gripping section of the inoculation device with a handling tool to releasably couple the handling tool to the grasping section of the inoculation device. The withdrawing step is accomplished by withdrawing the inoculation device from the cavity to unseal the seal carried by the inoculation device from the cavity and withdraw the inoculation device and the seal from the cavity for use. Finally, an optional releasing step is provided by releasing the inoculation device from the handling tool by displacing the inoculation device with an extendable member carried by the handling tool until the inoculation device is released from the handling tool.
Another aspect of the present invention is directed to an inoculation kit assembly comprising at least one inoculation device, a storage container, and a handling tool. The inoculation device including an elongated member having a gripping section, an inoculation section, and a seal carried by the elongated member, the seal having a surface formed for sealed engagement against the storage container. The storage container includes at least one cavity having an opening and a seal engagement portion dimensioned to receive and seal against the seal carried by the inoculation device. The inoculation device is mounted in sealed relation with the seal engagement portion for sealing the inoculation end in a sterile conditio
DeVaughn Donald H.
Ott Wolfgang
DeVaughn Donald H.
Dorsey & Whitney LLP
Redding David A.
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