Special receptacle or package – Combined or convertible – Packaged assemblage or kit
Reexamination Certificate
2002-08-20
2004-08-24
Luong, Shian T. (Department: 3728)
Special receptacle or package
Combined or convertible
Packaged assemblage or kit
C206S570000, C206S459500
Reexamination Certificate
active
06779665
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The subject invention is directed to a kit for collecting and maintaining biological material from an individual, such as material containing genetic information, as well as ancillary information about the individual.
2. Background of the Related Art
It is well known that genetic information is contained in a wide variety of biological tissues. DNA, the carrier of genetic information, is contained in nearly every cell of every living organism. This genetic information may be found in hair follicles, nails, teeth, skin cells, white blood cells, semen, and components of saliva. Urine, while not itself a carrier of genetic information, routinely includes components such as epithelial cells which contain ample genetic material for most purposes.
Genetic information collected from such biological samples may be utilized for a number of purposes. Among the many uses of genetic information collected from biological samples are identification of individuals; genetic testing and screening for hereditary conditions, diseases and disorders; and paternity and familial testing. In one illustrative use, parents may collect and safely store biological materials containing genetic information from their children. In the unfortunate event that a child subsequently goes missing, the parents can use the saved genetic material to aide in investigations concerning their missing child. Crime scene investigators can compare traces of biological materials left at a particular crime scene with the materials previously collected by the parents to help determine whether the child was previously at the crime scene in question.
As a further example, victims of rape may undergo physical examination after the crime has been committed in order to gather evidence. During this examination, reference samples of the victim's blood, saliva and/or hair may be collected, as well as any biological artifacts of the assailant which may be found on the victim's person. Genetic information of criminal assailants may be found in: saliva from bite marks; blood or skin cells from fingernail scrapings; semen or skin cells from inside or outside surface of condoms; semen, sweat, hair or saliva from blankets, pillow cases, sheets or other bed linens; hair, semen, blood or sweat from garments worn during or after an assault; and saliva from cigarette butts.
Genetic material may be collected from a variety of sources in a number of different manners. For example, living cells may scraped from soft tissue such as the basal mucosa (the lining of the mouth) using hard scrapers designed for such purposes. Alternatively, bodily fluids or cells may be collected using cotton swabs or similar devices, as disclosed, for example, in U.S. Pat. No. 6,291,171 to Ricciardi et al. which describes a kit for collection of basal mucosa cells utilizing cotton swabs. Additionally, bodily fluids may be collected using eyedroppers, pipettes or similar mechanisms designed for the uptake and dispensation of fluids. Similarly, fluids such as blood may be drawn directly from individuals by means of syringes generally utilized for such purpose. In many cases, it is normal practice to air dry specimens containing genetic material prior to storage.
Prior to acquisition of biological materials, it is important to ensure that the items to be used for sample collection and storage are free from contaminants such as biological materials originating from sources other than the intended source. Once cleaned of such foreign matter, the items must be maintained in such a manner so that they are not contaminated prior to their use. Individuals who are to collect and store the genetic material should be quickly able to ascertain whether the collection and storage articles have been maintained in a manner consistent with the goal of preventing contamination, or, conversely, if such protection against contamination has been compromised.
After being acquired, biological materials must be adequately stored until such time that analysis is to be undertaken. During storage, it is important that the collected samples be protected from contamination, degradation, and loss, among other detriments. To this end, it is desirable to store samples in sealable, protective containers. Suitable containers may include, among other types, sealable satchels such as zipper-sealable plastic or Tyvek brand bags, sealable paper or Glassine brand envelopes, and screw-cap enclosed glass or plastic vials. For example, U.S. Pat. No. 5,101,970 to Turner discloses a DNA collection kit which utilizes sealable plastic bags for storing collected materials.
During storage, it is important that samples be identifiable for such attributes as source, date of collection, location of collection and other pertinent information. To this end, one or more of a variety of labeling mechanisms may be employed, including markeable adhesive labels, string tags and markeable sleeves, among others. The labeling mechanisms should be capable of substantially permanent marking and should be resistant to alteration once marked.
In addition to genetic materials, individuals may wish to record and/or store ancillary information to augment genetic information. Such information may include dental records of individuals, which are often used to identify decomposed human remains; fingerprints, which are often used to identify individuals who had been present at crime scenes; and vital statistics such as name, eye color, hair color, birth date, height, weight, distinguishing marks, native language, mother's and father's names, guardian or next-of-kin contact information, blood type, medical conditions, necessary medications, and gender, among others. Photographs of individuals may also be stored to augment collected genetic information. When such information is collected and stored for children, it is advisable to update the information on a regular basis to ensure the information remains accurate as the child grows.
It is desirable, therefore, to provide a kit providing individuals with all the requirements for proper collection and storage of biological samples containing genetic information. It is also desirable to include in the aforementioned kit additional means to record and store ancillary information with which to augment the biological samples containing genetic information.
SUMMARY OF THE INVENTION
The subject invention is directed to a new and useful genealogy storage kit and more particularly to a biological sample collection and storage kit. The kit includes a plurality of biological sample storage devices, a plurality of biological sample collection devices configured to collect biological samples for placement into the biological sample storage devices, a plurality of biological sample identification devices for identifying the contents of the sample storage devices. The kit further includes a housing having a base portion and a lid portion hinged together to form an interior cavity for accommodating the plurality of biological sample storage devices, the plurality of biological sample collection devices and the plurality of biological sample identification devices.
In one embodiment of the invention, a preformed insert is disposed within the base portion of the housing which has a plurality of recesses dimensioned and configured to retain the plurality of biological sample storage devices. In another embodiment, the housing includes a latch for maintaining the lid portion and the base portion in a closed position.
Preferably, the plurality of biological sample storage devices include closable storage vials, and more particularly, a plurality of glass storage vials and plastic storage vials of varying capacity. Other types of sample storage devices may also be included, such as sealable bags, pouches and the like. The plurality of biological sample collection devices are selected from the group consisting of scrapers, swabs, syringes and pipettes. Other type of sample collection devices may also be included, such as tweezers or the like
Edwards & Angell LLP
Luong Shian T.
Wofsy Scott D.
LandOfFree
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