What is WIPO ST.25 and how does it relate to patent applications?
WIPO ST.25 is a standard for the presentation of nucleotide and amino acid sequence listings in patent applications. It was used for applications filed before July 1, 2022. The MPEP notes: “This section is not applicable to applications filed on or after July 1, 2022, having disclosures of nucleotide and/or amino acid sequences as defined…
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 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 viability requirement for biological material deposits in patent applications?
According to MPEP 2409, the viability requirement for biological material deposits is essentially a requirement that the deposited material is capable of reproduction. This is outlined in 37 CFR 1.807(a), which states: “A deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and…
Read MoreWhat are the submission options for ASCII plain text sequence listings to the USPTO?
According to MPEP 2422.03(a), there are several options for submitting ASCII plain text sequence listings to the USPTO: Via EFS-Web (now Patent Center) as a text file. On a compact disc (CD) or Digital Video Disc (DVD). As part of a patent application filing via EFS-Web. The MPEP states: “ASCII plain text files are permitted…
Read MoreHow do the Sequence Rules relate to WIPO Standard ST.26?
The USPTO Sequence Rules are closely aligned with the World Intellectual Property Organization (WIPO) Standard ST.26. MPEP 2412.01 states that the XML file of the sequence information must conform to requirements that “specify requirements of particular paragraphs of WIPO Standard ST.26.” WIPO Standard ST.26 is an international standard for the presentation of nucleotide and amino…
Read MoreWhen did the USPTO start requiring Sequence Listing XML for patent applications?
The USPTO began requiring Sequence Listing XML for certain patent applications on July 1, 2022. As stated in MPEP 2419: “[Editor Note: This section is applicable to all applications filed on or after July 1, 2022, having disclosures of nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b).]” This requirement applies to patent…
Read MoreHow should the <213> numeric identifier be used in a sequence listing?
The numeric identifier in a sequence listing has a specific use according to the Manual of Patent Examining Procedure (MPEP). As stated in MPEP 2424.02: “ is used for the name of the organism from which the sequence was obtained” This means that when providing a sequence listing, you should use the identifier to specify…
Read MoreWhat constitutes ‘undue experimentation’ in the context of biological material deposits?
‘Undue experimentation’ in the context of biological material deposits refers to procedures that require excessive effort or resources beyond what is considered routine in the field. According to MPEP 2404.02: “Deposits may be required to support the claims if an isolation procedure requires undue experimentation to obtain the desired biological material.” This means that if…
Read MoreHow does one make a timely election to proceed under pre-AIA 35 U.S.C. 103(b)?
Making a timely election to proceed under pre-AIA 35 U.S.C. 103(b) is crucial for applicants seeking to benefit from this provision. The MPEP provides guidance on what is considered timely: An election will normally be considered timely if it is made no later than the earlier of either the payment of the issue fee or…
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