How does the MPEP define standard amino acids?
While the MPEP doesn’t directly define standard amino acids, it indirectly provides this information by referencing WIPO Standard ST.26. According to MPEP 2412.03(c): WIPO Standard ST.26, paragraph 3(e), identifies “modified amino acid” to mean any amino acid as described in the definition of “amino acid”, other than L-alanine, L-arginine, L-asparagine, L-aspartic acid, L-cysteine, L-glutamine, L-glutamic…
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 MoreWhen did the new rules for “modified amino acids” in patent applications come into effect?
The new rules regarding “modified amino acids” in patent applications came into effect on July 1, 2022. This is clearly stated in the MPEP 2412.03(c): [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).]…
Read MoreWhat is considered a “modified amino acid” according to the MPEP?
According to MPEP 2412.03(c), a “modified amino acid” is defined as follows: “Modified amino acid” includes any amino acid as described in paragraph 3(e) of WIPO Standard ST.26. This definition is further elaborated in WIPO Standard ST.26, which states that a modified amino acid is any amino acid other than the 22 standard amino acids…
Read MoreWhat is the requirement for exclusive conformance in sequence disclosures?
The requirement for exclusive conformance in sequence disclosures is outlined in 37 CFR 1.821(b), which states that all applications disclosing nucleic acid and/or amino acid sequences falling within the definition set forth in 37 CFR 1.821(a) must conform exclusively to the requirements of 37 CFR 1.821 through 37 CFR 1.825. This requirement applies to the…
Read MoreWhat does “enumeration of its residues” mean in patent applications?
“Enumeration of its residues” refers to the disclosure of a nucleotide or amino acid sequence in a patent application. According to MPEP 2412.02(a), it means: “disclosure of a nucleotide or amino acid sequence in a patent application by listing, in order, each residue of the sequence, where the residues are represented in the manner as…
Read MoreWhy are all sequences, claimed or not, required in patent applications?
All sequences, whether claimed or only disclosed, are required in patent applications for several important reasons. According to MPEP 2421.02: “All such sequences are relevant for the purposes of building a comprehensive database and properly assessing prior art. It is therefore essential that all sequences, whether only disclosed or also claimed, be included in the…
Read MoreWhat regulation governs the requirements for patent applications with nucleotide and/or amino acid sequence disclosures?
The requirements for patent applications with nucleotide and/or amino acid sequence disclosures are governed by 37 CFR 1.831. This is referenced in MPEP 2412.03(c): 37 CFR 1.831 Requirements for patent applications filed on or after July 1, 2022, having nucleotide and/or amino acid sequence disclosures. This regulation sets forth the specific requirements that patent applicants…
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