When is a deposit of biological material not necessary for patent applications?
A deposit of biological material is not necessary for patent applications when the required biological materials can be made or isolated without undue experimentation. This is explicitly stated in MPEP 2404.02: “Applicant may show that a deposit is not necessary even though specific biological materials are required to practice the invention if those biological materials…
Read MoreWhat is the purpose of the viability statement in patent deposits?
What is the purpose of the viability statement in patent deposits? The viability statement in patent deposits serves to confirm that the deposited biological material is capable of self-replication, either directly or indirectly. According to MPEP 2409, “The term ‘viability’ is specifically defined in the regulations as ‘the capability of a biological material to self-replicate…
Read MoreHow often must viability testing be performed on deposited biological materials?
How often must viability testing be performed on deposited biological materials? According to MPEP 2409, viability testing must be performed on deposited biological materials at regular intervals. The MPEP states, “The regulations require that deposited biological material be viable at the time of deposit and at any time during the term of the patent.” However,…
Read MoreWhat happens if a deposited biological material loses viability during the patent term?
What happens if a deposited biological material loses viability during the patent term? If a deposited biological material loses viability during the patent term, it can have serious implications for the patent. According to MPEP 2409, “When the original deposit or any replacement deposit becomes nonviable, it must be replaced by the applicant, patent owner,…
Read MoreWhat is considered “biological material” for patent deposit purposes?
According to MPEP 2403, “biological material” is defined in terms of a non-exhaustive list of representative materials that can be deposited for patent purposes. The MPEP states: “For the purposes of these rules, the term ‘biological material’ is defined in terms of a non-exhaustive list of representative materials which can be deposited in accordance with…
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