How should sequence variants be presented in a patent application?

According to MPEP 2422.01, sequence variants in patent applications can be presented as follows:

1. Present a single, primary sequence in the specification and “Sequence Listing” by enumeration of its residues.
2. Discuss and/or claim variants of that primary sequence without presenting each variant as a separate sequence in the “Sequence Listing”.
3. Annotate the primary sequence in the “Sequence Listing” to reflect such variants.

The MPEP states: “It is generally acceptable to present a single, primary sequence in the specification and “Sequence Listing” by enumeration of its residues in accordance with the sequence rules (“primary sequence”) and to discuss and/or claim variants of that primary sequence without presenting each variant as a separate sequence in the “Sequence Listing”.“

However, if a variant sequence meets the length thresholds of 37 CFR 1.821(a) and is disclosed by enumeration of its residues anywhere in the application, it must be presented in a “Sequence Listing” in compliance with the sequence rules.

Examples:

• For “conservatively modified variants,” you can describe them as “SEQ ID NO:X and conservatively modified variants thereof.”
• For sequences with potential deletions, only the sequence without deletions needs to be included in the “Sequence Listing,” but it’s recommended to annotate the sequence to indicate possible deletions.

It’s strongly recommended to include any sequences appearing in the claims or essential to understanding the invention as separate sequences in the “Sequence Listing.”

To learn more:

• Sequence variants
• patent applications
• Sequence Listing
• primary sequence
• conservatively modified variants