Are there any exceptions to the requirement for incorporating the “Sequence Listing XML” by reference?

Yes, there is an exception to the requirement for incorporating the “Sequence Listing XML” by reference. According to MPEP 2413.04 and 37 CFR 1.834(c)(2):

“If the ‘Sequence Listing XML’ required by § 1.831(a) is submitted in XML file format via the USPTO patent electronic filing system or on a read-only optical disc (in compliance with § 1.52(e)) for an international application during the international stage, then an incorporation by reference statement of the material in the XML file is not required.”

This means that for international applications during the international phase, where the “Sequence Listing XML” is submitted electronically or on a read-only optical disc, no incorporation by reference statement is needed.

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Topics: MPEP 2400 - Biotechnology, MPEP 2413.04 - Requirements Regarding Incorporation By Reference Of The "Sequence Listing Xml", Patent Law, Patent Procedure
Tags: exceptions, incorporation by reference, international applications, sequence listing xml