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4.6 Micro-organism Deposits


One potentially problematical area relating to sufficiency has been in relation to inventions relating to microorganisms in cases where the microbe being claimed or that is required to be used is not generally available to the public. Provision in the specification of full details as to how to obtain the organism in question from natural sources may suffice to meet the requirements of 35 USC § 112 even without a deposit. [67] In re Argoudelis [68] it was held that a microorganism needed for the performance of a patented invention must be permanently available to the public once the patent had issued and that the microorganism must have been deposited in a culture collection before filing the patent application. It has, however, been held that in cases where deposit of a microorganism is necessary in order to meet the sufficiency requirement, the depository in which the deposit is made need not be independent. [69] The court further held that in this case one could add to the specification information relating to the details of a deposit with an independent depository after filing the application. For foreign applicants, it is common to rely on the provisions of the Budapest Treaty to meet the deposit requirements. However, care should be taken in doing this.

In Ex parte Hildebrand [70], the Board of Appeals was confronted with the question of whether a "simple" Budapest deposit complied with the requirement that in cases where an invention involves the use of a microorganism which is not generally available or which cannot be adequately described in an application, the applicant must provide an assurance that upon grant of any patent samples of a culture of that microorganism shall be freely available. The Board concluded that it did not. It reached this conclusion notwithstanding the provision in the rules attached to the Budapest Treaty that in respect of patents granted and published by any industrial property office, that office may from time to time communicate to the international depositary where the microorganism is on deposit a list of accession numbers given by that authority to deposits referred to in granted patents. The Treaty itself requires that once such notification has been given, the depositary has to release the organism to anyone who requests it. The majority of the Board concluded that this rule did not impose a positive obligation relating to granted patents on international depositaries and, thus, there was no assurance that microorganisms would be released once the U.S. patent was granted.

It, therefore, seems that it would behoove applicants who are relying on deposits of microorganisms under the Budapest Treaty to comply with U.S. enablement requirements to take some positive steps to ensure that microorganisms will be released to the general public once a patent has been issued. One way to do this might be to insert into the declaration at the time of the original deposit a statement that samples should be released to anyone who can show that the deposit number was referred to in a granted United States patent.




[67] Thus, in In re Wands it was held:

No deposit is necessary if the biological organisms can be obtained from readily available sources or derived from readily available starting materials through routine screening that does not require undue experimentation.

See also Ex parte Rinehart, 10 USPQ2d 1719 (Bd of Apps 1989).
[68] 434 F.2d 1390 168 USPQ 99.
[69] In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985).
[70] 15 USPQ2d 1662 (Bd of Apps 1990).


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© Copyright 2002 John Richards - Posted July 2002
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