Method and system for identifying commercially distributed...

Data processing: measuring – calibrating – or testing – Measurement system in a specific environment – Biological or biochemical

Reexamination Certificate

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Details

C435S006120, C435S091100, C435S320100, C435S471000, C536S023100

Reexamination Certificate

active

06629038

ABSTRACT:

FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to a method and system for identifying commercially distributed organisms and/or offspring thereof. More particularly, the present invention relates to (i) genetically marked organisms; and (ii) a database server and a method for assigning sequences to be used to genetically mark organisms and for book keeping data pertaining to the genetically marked organisms and/or their owner, producer or source.
There are a variety of reasons to have organisms tagged with an “easy to read” code. Such reasons, include, but are not limited to, (i) recognition of source; (ii) ownership; (iii) regulation; and (iii) liability.
For example, valuable bacterial or fungal strains, crop varieties, or animal strains need be identifiable for effectively effecting intellectual property (IP) rights or proof of ownership, as well as identity preservation.
Transgenic organisms bacterial or fungal strains, crop varieties, or animal strains need by identifiable for recognition of source.
In addition, regulatory authorities and various consumer groups are demanding labeling of certain transgenic commodities. They spend vast sums typically probing for common used promoters (35S, actin enhancer) or selectable marker genes (kanamycin or hygromycin resistance) and not for the trait genes, in an effort to save. Even when transgenics are discovered by such “kits”, there is no information as to source. Thus, regulatory authorities may wish to consider simple, common recognition sequences for detecting transgenics.
Organisms which serve as biocontrol agents should be tagged for reasons of liability. It will be appreciated in this respect that the use of live organisms to control weed, bacterial, fungal, or insect pests is increasing. Many of the agents are closely related to known pathogens or pests and there have already been claims that a biocontrol organism changed its host range and attacked valuable species. In all probability, the related species was the culprit. There are few easy methods to ascertain causality with accuracy in some cases. There are also fears that biocontrol agents will mutate or introgress with other organisms, and there are needs to know whether the biocontrol agent changed host range (with consequences of liability) or whether an epidemic was due to wild strains. These issues with biocontrol agents will become more acute with transgenically-enhanced biocontrol agents.
There is thus a great need for, and it would be highly advantageous to have, a database server and a method for assigning sequences to be used to genetically mark organisms and for book keeping data pertaining to the genetically marked organisms their owner, producer or source.
SUMMARY OF THE INVENTION
According to one aspect of the present invention there is provided a method of marking individuals of commercially distributed organism or organisms and offspring thereof, the method comprising the step of genetically marking a plurality of individuals of the organism or organisms with a plurality of unique DNA sequences, each of the unique DNA sequences includes a variable region, so as to produce artificial, inherited and detectable genetic variability among the plurality of individuals of the commercially distributed organism or organisms.
According to another aspect of the present invention there is provided a method of identifying individuals belonging to a commercially distributed organism, the method comprising the steps of (a) genetically marking a plurality of individuals of the organism with a plurality of unique DNA sequences, each of the unique DNA sequences includes at least one variable region; (b) providing a database server including a lookup table associating each of the plurality of individuals with one of the plurality of unique DNA sequences; and (c) identifying whether an examined individual of the organism being one of the plurality of individuals or offspring thereof, and if so, which of the plurality of individuals or offspring thereof, by (i) determining a presence or absence, and if present, a nucleotide sequence of a unique DNA sequence of the plurality of unique DNA sequences by which the examined individual being genetically marked; and (ii) identifying the examined individual by associating the nucleotide sequence to one of the plurality of individuals via the lookup table of the database server.
According to yet another aspect of the present invention there is provided an organism having a genome, the organism being genetically marked by (a) at least one unique DNA sequence which is known in public; and (b) at least one unique DNA sequence that is unknown, at least not as a genetic mark, in public.
According to still another aspect of the present invention there is provided a system for assigning DNA sequences to serve as genetic markers of commercially distributed organisms, the system comprising a database server being designed and constructed for managing a sequences database and serving for (a) assigning at least one sequence of the sequences to an assignee upon request; and (b) book-keeping data pertaining to step (a).
According to an additional aspect of the present invention there is provided a method assigning DNA sequences to serve as genetic markers of commercially distributed organisms, the method is effected by a data processor operatively communicating with a sequences data base and comprising the steps of (a) assigning at least one sequence of the sequences to an assignee upon request; and (b) book-keeping data pertaining to step (a).
According to further features in preferred embodiments of the invention described below, the request is effected via a communications network, such as the Internet
According to still further features in the described preferred embodiments the data pertaining to step (a) includes an identity of the assignee and/or an identity of an organism.
According to still further features in the described preferred embodiments the database server further serves for debiting the assignee and the method further comprising the step of debiting the assignee.
According to still further features in the described preferred embodiments each of the sequences includes a variable region. Preferably, each of the sequences includes a pair of universal regions, one on each side of the variable region.
According to still further features in the described preferred embodiments the database server further serves for (i) receiving a sequence input from a user and comparing the sequence input to sequences of the sequences database which have already been assigned; and, if no matching sequence is found (ii) identifying the user as an assignee of the sequence input. Thus, the method further comprising the steps of (c) receiving a sequence input from a user and comparing the sequence input to sequences of the sequences database which have already been assigned; and, if no matching sequence is found; (d) identifying the user as an assignee of the sequence input.
According to still further features in the described preferred embodiments the system further comprising a DNA synthesizer being in data communication with the database server, the DNA synthesizer serving for automatically synthesizing assigned sequences. The method, thus, further comprising the step of communicating assigned sequences to a DNA synthesizer.
According to still further features in the described preferred embodiments the database server includes an application selected from the group consisting of (i) determining sequence identity; (ii) determining sequence homology and degree thereof; (iii) generating artificial sequences; (iv) combining sequences of different origins; (v) generating random sequences; (vi) evaluating a coding potential of a sequence; and (vii) scoring a coding potential of a sequence.
According to another aspect of the present invention there is provided a kit for marking individuals of commercially distributed organism or organisms and offspring thereof, the kit comprising a plurality of containers containing a plurality of DNA

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