Registers – Systems controlled by data bearing records
Reexamination Certificate
2000-03-07
2003-12-09
Lee, Michael G. (Department: 2876)
Registers
Systems controlled by data bearing records
C235S385000, C235S462010, C235S462150, C235S449000
Reexamination Certificate
active
06659338
ABSTRACT:
DESCRIPTION
1. Field of the Invention
Very different requirements are made with respect to the withdrawal and handling of biological specimens. These relate to quantity, purity, reliability and in several cases, in fact, the speed at which they are taken. New, rapid analytical methods make necessary the simplification of sampling, in order to achieve a decrease in the total analysis cost. High requirements are placed also on the logistics of such a process, due to the withdrawal of large numbers of samples
Large numbers of biological analyses are of importance in medicine, research, breeding [cultivation], quality-control and environmental technology. In all these fields, the following parameters determine the requirements that are placed on a sampling system.
1) The number of samples to be taken.
2) The degree of centralizing of the analyses, i.e., whether samples taken at several points in large quantity are processed at one site, where the sorting process for the analytical process must occur efficiently. Another requirement, the labeling of samples, is derived from such a situation, as [also] in the case of a decentralized analysis of the same number of samples.
3) The quantity of data to be processed for the analysis.
4) The degree of training of the personnel who withdraw the samples.
5) The price that an analysis costs and the price that the analysis should cost, measured according to the value of the organism to be investigated.
6) The tolerance of the sampling and the analytical system to errors.
7) The time required for the individual samples to be removed.
8) The quantity and uniformity of the sample volume which must be withdrawn or filled per sampling.
Depending on the application, several of the above-named items have greater or lesser importance. The invention concerns a method that serves to overcome the logistics problems in sampling, recording and processing huge quantities of samples.
Ersatzblatt (Regel 26)=Substitution page (Regulation 26)—written at the bottom of each page—Translator's note.
2. Prior Art and Objectives in Human Medicine
The prior art in the withdrawing of medical samples varies greatly, depending on the application. In principle, biopsies can be differentiated from simple blood, urine or saliva samples.
Various designs of biopsy needles, even automated designs (Burbank et al. U.S. Pat. No. 5,526,822) are known, but all of these are constructed for the withdrawal of small specimens under difficult surgical conditions. These devices require a considerable degree of training. In addition, these devices must be sterilized after use and the samples must be individually packed and labeled.
Consequently, all biopsy devices according to the prior art are constructed for applications other than the method according to the invention and do not fulfill the requirements that are placed on it.
In the withdrawing of saliva, mucus or pus, there are also variants in which the actual sample remover, which is often, e.g., absorbent cotton or folded fabric, is attached directly in the cover of the future specimen container (Holzhäuser et al. DE 3,247,719 A1). The specimen is taken, the cover with the empty container is screwed on or otherwise engaged, so that the cotton wad or folded fabric comes to lie inside the container. These containers are usually provided with a self-adhering barcode.
3. Prior Art in Cattle Breeding
In the case of cattle breeding, for genetic engineering investigation, which has been conducted as yet only to a small extent, the tissue sample is removed by introducing several hair roots of the animal into a sample container. The sample container is sealed and manually inscribed with a numerical code or concrete data. This method does not represent a satisfactory solution, since in the case of large livestock, much time is required due to the many operating steps. It is shown in practice that if the person who withdraws the samples is not directly familiar with specimen analysis or has not been specially trained, irregularities may occur with respect to the quantity of the sample, impurities of the sample or even test capsules without content or with falsified content. Milk cows and the cattle raised for meat production are subject to very different regulations, which prescribe repeated standard investigations. In these cases, among other things, blood samples are withdrawn by a veterinarian. Several special investigations presently do not require blood samples and could theoretically be replaced without problem by a very small tissue sample. Animal breeders and fatteners could save considerable veterinary costs by a method for withdrawing tissue that is simple to manipulate.
Throughout Europe, the registration of cattle has been undertaken starting from Jan. 1, 1998, so that each calf is provided with two ear marks within the first month of life—one in each ear. The country of origin (e.g., DE for Germany, GB for England, etc.) of the animal and a registration number composed of several digits is recorded on both marks. In many cases also, a barcode is used in addition to the number. The only security from loss and misuse is that an animal bears two ear marks with an identical data set. Based on the size of the ear marks, these are very frequently torn off, so that only one mark remains on the animal. A new mark with a corresponding code must be requested from the cattle raising association. In the case of spotted cattle, a drawing replaces the labeling of the respective animal. This drawing is later replaced by a Polaroid picture of the calf. However, since Brown cattle are primarily used for meat production, this additional control is omitted in essential cases. Numbers of ear marks and markings are established in the handbook of the association of the respective country. Tests have also been conducted with subcutaneously implanted transponders. However, these devices can migrate into the body of the animal over the course of its life, so that they can no longer be found during slaughtering and can end up in sausage.
4. Prior art in Plant Cultivation
The diagnosis of infectious diseases in agriculturally important plants would be evaluated as a primary application.
Presently there is no system, which is able to efficiently conduct the withdrawing and clear labeling of the millions of samples and their centralized processing. At the present time, all samples are taken manually, at most with the help of “forceps” and placed in a labeled vessel with tweezers or by hand. The quantities of the removed tissue are not constant, so that each step of the further processing of the samples requires manual intervention, which can lead to errors. Since a presymptomatic procedure often seems troublesome, there is the danger that deliberately false samples will be taken, if the result is not directly utilized. A farmer in fact could fear loss due to the ordered destruction of an entire harvest. In this way, circumstances are provided for intentional fraud. Nevertheless, if a presymptomatic system is to be introduced, certain controls are necessary. The cheaper such a method is, then the greater the need for conducting such controls by automated techniques.
Huge quantities of samplings are necessary for cultivation efforts. In the case of cultivation, the plants must be characterized and one must be able to accurately trace the sample back to its origin, but these methods require an enormous organizational expenditure. Since these methods are still usually conducted manually at the present time, cultivation efforts require considerable expenditure of personnel. This is the primary cost factor in the cultivation of new varieties.
The development of genetically manipulated plants is an enormous investment for the grower. Of course, every grower wants the results of his efforts to be secured legally against unpermitted copying. In theory, the legal basis is given for this. Nevertheless, reliable protection is based on controls. The trade of seed material is global. It is conceivable that huge quantities of random sampl
Dittmann Thomas Claus
Gut Ivo Glynne
Heuermann Arno Svend
Olek Alexander
Biopsytec GmbH
Kim Ahshik
Kreigsman & Kriegsman
Lee Michael G.
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