What is the significance of a Budapest Treaty deposit for biological materials in patent applications?
A Budapest Treaty deposit can be significant for biological materials in patent applications, but it doesn’t automatically ensure that the material is considered known and readily available. According to MPEP 2404.01: “Even a deposit made under the Budapest Treaty and referenced in a United States or foreign patent document would not necessarily meet the test…
Read MoreWhat is considered biological material capable of self-replication?
Biological material capable of self-replication includes material that can reproduce either directly or indirectly. According to MPEP 2403.01: “Biological material includes material that is capable of self-replication either directly or indirectly. Direct self-replication includes those situations where the biological material reproduces by itself.” Examples of directly self-replicating materials are provided in the rule. Indirect self-replication…
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…
Read MoreIs an actual reduction to practice required before filing a patent application for biological material?
No, an actual reduction to practice is not a prerequisite for filing a patent application, even for biological materials. The MPEP 2406.02 clearly states: “[T]here is no requirement in the patent law that an actual reduction to practice occur as a condition precedent to filing a patent application.” This means that inventors can file patent…
Read MoreIs it possible to satisfy 35 U.S.C. 112 description requirements if the biological material didn’t exist at the filing date?
While it’s extremely rare, the MPEP 2406.02 does not completely rule out the possibility of satisfying the description requirements of 35 U.S.C. 112 even if the biological material didn’t exist at the filing date. The MPEP states: “While few, if any, situations can be imagined where the description requirement of 35 U.S.C. 112 can be…
Read MoreWhen must a reference to deposited biological material be furnished in a PCT application?
The timing for furnishing a reference to deposited biological material depends on several factors: If not included in the original application, indications can be furnished to the International Bureau within 16 months after the priority date. Some national laws may require earlier submission, as noted in PCT Rule 13bis.4(b). If the applicant requests early publication,…
Read MoreWhat information must be included in a reference to deposited biological material?
According to PCT Rule 13bis.3(a), a reference to deposited biological material must include: The name and address of the depositary institution The date of deposit of the biological material The accession number given to the deposit by the institution Any additional matter notified to the International Bureau, if applicable For U.S. requirements, additional information may…
Read MoreHow are references to deposited biological material handled for different designated states in a PCT application?
The handling of references to deposited biological material for different designated states in a PCT application is addressed in PCT Rule 13bis.5: A reference is considered to be made for all designated states unless expressly made for certain states only. Different deposits of biological material may be made for different designated states. Designated offices may…
Read MoreWhat is a “reference to deposited biological material” in a PCT application?
According to PCT Rule 13bis.1, a “reference to deposited biological material” means “particulars given in an international application with respect to the deposit of a biological material with a depositary institution or to the biological material so deposited.” This reference is typically included when it’s necessary for disclosing the invention in a manner sufficient for…
Read MoreWhat are the rules regarding the furnishing of samples of deposited biological material in PCT applications?
The furnishing of samples of deposited biological material in PCT applications is governed by PCT Rule 13bis.6 and national laws. Key points include: Furnishing of samples is generally delayed until the start of the national phase. This delay ends when the applicant takes steps to enter the national phase or when international publication has effects…
Read More