Can an examiner require the submission of a Sequence Listing XML?
Yes, an examiner can require the submission of a Sequence Listing XML under certain circumstances. MPEP 2414 states: “Additionally, the examiner can require the filing of an added initial ‘Sequence Listing XML’ if the ‘Sequence Listing XML’ or a replacement ‘Sequence Listing XML’ if an application fails to comply with 37 CFR 1.831 – 1.834.”…
Read MoreWhich patent applications are subject to the new Sequence Listing XML requirements?
The new Sequence Listing XML requirements apply to specific patent applications, as stated in the MPEP: “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 means that any patent application filed on or after July…
Read MoreWhat types of patent applications require a Sequence Listing XML?
According to MPEP 2415, the Sequence Listing XML requirement applies to “Patent applications that contain disclosures of nucleotide and/or amino acid sequences.” This means any patent application filed on or after July 1, 2022, that includes biological sequence data as defined in 37 CFR 1.831(b) must submit this data in the Sequence Listing XML format…
Read MoreWhat are the requirements for the “organism” qualifier in a “Sequence Listing XML”?
The “organism” qualifier in a “Sequence Listing XML” is used to disclose the source or origin of the sequence. According to MPEP 2413.01(g): “The organism qualifier, i.e., ‘organism’ for nucleotide sequences and ‘organism’ for amino acid sequences must disclose the source, i.e., a single organism or origin, of the sequence. Organism designations should be selected…
Read MoreWhat is the optional ‘id’ attribute for language-dependent qualifiers in a Sequence Listing XML?
For language-dependent qualifiers in a Sequence Listing XML, an optional ‘id’ attribute can be included in the INSDQualifier element. This attribute has specific formatting requirements: The value must be in the format “q” followed by a positive integer (e.g., “q23”). The attribute value must be unique to one INSDQualifier element within the Sequence Listing XML…
Read MoreWhat is considered a “nucleotide” in a Sequence Listing XML?
According to MPEP 2412.03(d), a “nucleotide” in a Sequence Listing XML includes: Any nucleotide Nucleotide analogs Modified nucleotides The MPEP, citing WIPO Standard ST.26, specifies that a nucleotide must contain: A backbone moiety (e.g., 2′ deoxyribose 5′ monophosphate or an analogue) Either a nucleobase (including modified or synthetic purines or pyrimidines) or an “AP site”…
Read MoreCan I provide multiple InventionTitle elements in different languages?
Yes, you can provide multiple InventionTitle elements in different languages for your patent application. The MPEP 2413.01(i) states: “It is possible for an applicant to provide more than one InventionTitle element of the general information part in more than one language.” However, it’s important to note that for international applications where the USPTO is the…
Read MoreWhen is the MPEP 2412.05(c) guidance on sequence variants applicable?
The guidance provided in MPEP 2412.05(c) is applicable under specific conditions: “[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 means that the requirements for representing sequence variants in the “Sequence Listing XML”…
Read MoreWhat happens if a required “Sequence Listing XML” is missing or non-compliant in a patent application?
If a required “Sequence Listing XML” is missing or non-compliant in a patent application, the following process typically occurs: During pre-examination or initial review, USPTO staff or the examiner identifies that a “Sequence Listing XML” is required but missing or not compliant with 37 CFR 1.831-1.834. A notice indicating the deficiencies will be issued to…
Read MoreWhat are the mandatory qualifiers for the “source” feature key in a Sequence Listing XML?
The “source” feature key is mandatory for all nucleotide and amino acid sequences in a Sequence Listing XML, except for intentionally skipped sequences. According to MPEP 2413.01(g), there are two mandatory qualifiers for the “source” feature key: “organism” “mol_type” The “organism” qualifier must disclose the source or origin of the sequence, while the “mol_type” qualifier…
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