What is the viability requirement for biological material deposits in patent applications?
According to MPEP 2409, the viability requirement for biological material deposits is essentially a requirement that the deposited material is capable of reproduction. This is outlined in 37 CFR 1.807(a), which states:
“A deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit.”
It’s important to note that there is no requirement to provide evidence that the deposited material can perform any specific function described in the patent application. However, if the examiner has reason to question the statements made in the application, applicants may be required to demonstrate that the deposited material will perform as described.
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