What is the significance of the Enzo Biochem v. Calgene case in patent enablement?
The Enzo Biochem v. Calgene case is significant in patent enablement because it illustrates how courts assess the scope of enablement in biotechnology patents. The MPEP Section 2164.06(b) summarizes the case: “The court held that two patents with claims directed to genetic antisense technology (which aims to control gene expression in a particular organism), were…
Read MoreWhat is the enablement requirement for biotechnology patents with respect to biological deposits?
The enablement requirement for biotechnology patents with respect to biological deposits is based on 35 U.S.C. 112(a). According to MPEP 2411.01: “Rejection for lack of an enabling disclosure without access to a specific biological material. This ground of rejection should be accompanied by evidence of scientific reasoning to support the conclusion that a person skilled…
Read MoreHow should coding regions be depicted in patent applications?
According to 37 CFR 1.822(c)(3), if an applicant chooses to depict coding regions, the amino acids corresponding to the codons in the coding parts of a nucleotide sequence must be listed immediately below the corresponding codons. The MPEP states: “If applicant chooses to depict coding regions, 37 CFR 1.822(c)(3) requires the amino acids corresponding to…
Read MoreHow can an applicant demonstrate that a biological material deposit is not necessary?
An applicant can demonstrate that a biological material deposit is not necessary by showing that the required biological materials can be obtained or created through routine procedures. The MPEP 2404.02 states: “No deposit is required, however, where the required biological materials can be obtained from publicly available material with only routine experimentation and a reliable…
Read MoreWhat happens if a patent is granted without an election under pre-AIA 35 U.S.C. 103(b)?
If a patent is granted on an application that was entitled to the benefit of pre-AIA 35 U.S.C. 103(b), but no election was made due to an error, there is still a remedy available. The MPEP states: However, if a patent is granted on an application entitled to the benefit of pre-AIA 35 U.S.C. 103(b)…
Read MoreWhat are the consequences of failing to comply with sequence rules in a patent application?
Failing to comply with sequence rules in a patent application can have serious consequences. According to MPEP 2412.01: “Applicants are urged to submit sequence information in computer readable form concurrently with the filing of the application. Submission at the time of filing enables the examiner to promptly begin analyzing the sequence information as part of…
Read MoreWhat is a Computer Readable Form (CRF) of the Sequence Listing?
A Computer Readable Form (CRF) of the Sequence Listing is a digital version of the sequence information that must be submitted along with the patent application. According to MPEP 2421.02, the sequence rules include “the requirement for a computer readable form (CRF) of the ‘Sequence Listing’.” Key points about the CRF: It’s a mandatory submission…
Read MoreWhat are the grounds for rejection based on deposit issues in biotechnology patent applications?
The Manual of Patent Examining Procedure (MPEP) outlines several grounds for rejection based on deposit issues in biotechnology patent applications. These include: Lack of enablement under 35 U.S.C. 112(a) Lack of written description under 35 U.S.C. 112(a) Lack of best mode under 35 U.S.C. 112(a) Indefiniteness under 35 U.S.C. 112(b) Failure to claim what the…
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…
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