Is evidence required to show that a deposited biological material can perform its described function?
Generally, no specific evidence is required to show that a deposited biological material can perform its described function in a patent application. According to MPEP 2409:
“For the purpose of making a deposit under these rules, there is no requirement that evidence be provided that the deposited material is capable or has the ability to perform any function described in the patent application.”
However, it’s important to note that this doesn’t exempt the application from other patentability requirements. The MPEP further states:
“However, as with any other issue of description or enablement, if the examiner has evidence or reason to question the objective statements made in the patent application, applicants may be required to demonstrate that the deposited biological material will perform in the manner described.”
Therefore, while initial evidence isn’t required, applicants should be prepared to provide evidence if the examiner has reason to question the application’s statements about the deposited material’s functionality.
To learn more: