2404 Need or Opportunity to Make a Deposit
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The deposit may be referenced in the specification even if the deposit is not required to satisfy the requirements of 35 U.S.C. 112.
A deposit may not be necessary if the biological material is known and readily available to the public (both requirements must be met – known and readily available).
- The precise geographic location of the biological material will generally satisfy the known and readily available requirement
- Commercial availability will be accepted as known and readily available when the evidence is clear and convincing that the public has access to the material
A deposit may not be necessary if the biological materials required to make and use the invention can be made or isolated without undue experimentation.
