Paragraph 3(c) Definition of of its residues” – “enumeration Example 3(c)-1: Enumeration of amino acids by chemical structure Question 1: Does ST.26 require inclusion of the sequence(s)? YES The enumerated peptide, illustrated as a structure, contains at four specifically defined amino acids. Therefore, the sequence must be included in a sequence listing. Question 3: How should the sequence(s) be represented in the sequence listing? The sequence may be represented as: VAFXGK (SEQ ID NO: 2) wherein represents an modified amino acid: , which requires a feature “X” key together with the qualifier The qualifier provides the complete, unabbreviated name of “SITE” “NOTE”. “NOTE” the modified tryptophan in position 4 of the enumerated peptide, e.g., “6-amino-7-(1H-indol-3-yl)-5-oxoheptanoic acid”. Further, additional feature keys and qualifier are required to indicate the acetylation of the “SITE” “NOTE” terminus and the methylation of the C-terminus. Alternatively, the sequence may be represented as: VAFW (SEQ ID NO: 3) A feature key and qualifier are required to indicate modification of tryptophan in position 4 of the “SITE” “NOTE” enumerated peptide with the value: linked via a glutaraldehyde bridge to dipeptide GK”. Further, an “C-terminus additional feature key at location 1 and qualifier is required to indicate the acetylation of the “SITE” “NOTE” Relevant ST.26 paragraphs: Paragraphs 3(c), 7(b), 29, 30, and 31
Paragraph 3(c) – Definition of “enumeration of its residues” Example 3(c)-1: Enumeration of amino acids by chemical structure Question 1: Does ST.26 require inclusion of the sequence(s)? YES The enumerated peptide, illustrated as a structure, contains at four specifically defined amino acids. Therefore, the sequence must be included in a sequence listing. Question 3: How should the sequence(s) be represented in the sequence listing? The sequence may be represented as: VAFXGK (SEQ ID NO: 2) wherein “X” represents an modified amino acid: , which requires a feature key “SITE” together with the qualifier “NOTE”. The qualifier “NOTE” provides the complete, unabbreviated name of the modified tryptophan in position 4 of the enumerated peptide, e.g., “6-amino-7-(1H-indol-3-yl)-5-oxoheptanoic acid”. Further, additional feature keys “SITE” and qualifier “NOTE” are required to indicate the acetylation of the and the methylation of the C-terminus. Alternatively, the sequence may be represented as: VAFW (SEQ ID NO: 3) A feature key “SITE” and qualifier “NOTE” are required to indicate modification of tryptophan in position 4 of the enumerated peptide with the value: “C-terminus linked via a glutaraldehyde bridge to dipeptide GK”. Further, an additional feature key “SITE” at location 1 and qualifier “NOTE” is required to indicate the acetylation of the Relevant ST.26 paragraphs: Paragraphs 3(c), 7(b), 29, 30, and 31 terminus
cws_6_16-annex6.docx