When is it appropriate to include sequences in patent drawings?
While sequences should generally be included in the Sequence Listing XML rather than duplicated in drawings, there are several situations where including sequences in patent drawings may be appropriate or necessary. According to MPEP 2412.06: “Many significant sequence characteristics may only be demonstrated by a figure. This is especially true in view of the fact…
Read MoreWhen is a replacement “Sequence Listing XML” required in a patent application?
A replacement “Sequence Listing XML” is required in a patent application under the following circumstances: When errors are identified in a previously submitted “Sequence Listing XML” When the previously submitted “Sequence Listing XML” fails to comply with 37 CFR 1.831 – 1.834 When the applicant chooses to amend a previously submitted “Sequence Listing XML” According…
Read MoreWhen might an applicant need to replace a biological deposit?
An applicant might need to replace a biological deposit when the original deposit is no longer viable. According to the MPEP, “Replacement will typically take place where the earlier deposit is no longer viable.” This could occur if the deposited material has degraded, lost its ability to replicate, or become contaminated to the point where…
Read MoreWhen 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 WIPO Sequence Validator?
The WIPO Sequence Validator is a tool developed by WIPO for use by Intellectual Property Offices (IPOs) to validate Standard ST.26 “Sequence Listing XML” files. As explained in MPEP 2418: To ensure that IPOs can validate and accept sequence listing projects from applicants generated with WIPO Sequence, WIPO is developing a Standard ST.26 “Sequence Listing…
Read MoreWhat is the WIPO Sequence Tool?
The WIPO Sequence Tool is a desktop application developed by WIPO and adopted by WIPO member states, including the US, to help patent applicants generate compliant “Sequence Listing XML” files. As stated in MPEP 2418: WIPO Sequence has two functions: An authoring function and a validation function. Patent applicants will be able to author and…
Read MoreWhat is a “Sequence Listing” in patent applications?
A “Sequence Listing” is a separate part of a patent application that contains disclosures of nucleotide and/or amino acid sequences, along with associated information, using a standardized format and symbols. According to MPEP 2421.01, it is required for applications containing disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR…
Read MoreWhy are viruses mentioned in both direct and indirect self-replication categories?
The MPEP 2403.01 mentions viruses in both direct and indirect self-replication categories to illustrate that these categories are not mutually exclusive. The MPEP states: “The list of representative examples of each type of replicating material includes viruses to demonstrate that the two lists in the rule are not intended to be mutually exclusive.” This inclusion…
Read MoreWhat information must be included in a viability statement for non-Budapest Treaty deposits?
For biological material deposits not made under the Budapest Treaty, a viability statement must be filed with the patent application. According to MPEP 2409 and 37 CFR 1.807(b), this statement must contain: The name and address of the depository The name and address of the depositor The date of deposit The identity of the deposit…
Read MoreWhat are the requirements for viability of deposited biological materials?
The viability of deposited biological materials is a crucial aspect of the deposit process. According to MPEP 2410.01, the following requirements apply: The deposit must be viable at the time it is made. The deposit must be tested for viability. The deposit must be replaced if it becomes non-viable. As stated in the MPEP: “The…
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