What statements are required when amending a “Sequence Listing XML”?

When amending a “Sequence Listing XML”, three key statements are required:

1. A statement identifying the location of all changes
2. A statement identifying the basis for all changes
3. A statement that no new matter is introduced

As specified in MPEP 2414.03:

• A statement that identifies the location of all additions, deletions, or replacements of sequence information relative to the replaced “Sequence Listing XML” (37 CFR 1.835(b)(3))
• A statement identifying the basis for the additions, deletions, or replacements of the sequence information in the application as originally filed for all amended sequence data in the replacement “Sequence Listing XML,” which would include, e.g., pages of specification where a sequence is disclosed or drawing sheets identifying the sequence which is part of the replacement “Sequence Listing XML” (37 CFR 1.835(b)(4))
• A statement that no new matter is introduced by the content of the XML file containing the replacement “Sequence Listing XML” (37 CFR 1.835(b)(5))

These statements ensure transparency in the amendment process and compliance with patent regulations.

To learn more:

• Sequence Listing XML
• Patent Amendment
• USPTO Requirements
• Biotechnology Patents