USPTO Granted Remand in Important Antibody Written Description Case

by Dennis Crouch

The Federal Circuit has remanded the Xencor appeal — allowing USPTO  leadership an opportunity to re-focus on the written description requirement for both Jepson claims and means-plus-function claims in the antibody art.  I have several prior posts about the case:

• Crouch, USPTO again Asks for Remand in Xencor to reconsider its Decisions (December 7, 2023)
• Crouch, Motion for remand in Xencor (December 4, 2023)
• Crouch, Jepson Formats and Means Limitations Under More Fire (November 29, 2023)

The core issues on appeal focus on (1) whether statutory equivalents under 35 U.S.C. 112(f) require explicit written description support beyond the disclosed structure; and (2) whether Jepson claim preambles require written description support even though they do not limit the claim scope. The PTAB sided against the patentee on both issues and held that 112(f) equivalents require written description support and Jepson preambles also require explicit written description.  Xencor appealed to the Federal Circuit.  The USPTO initially sought an extension to file its brief in opposition, and then requested remand of the case just days before the extended deadline. In particular, the USPTO  indicated that the Director planned to reconsider those conclusions by the PTAB.

In its motion for remand, the USPTO particularly noted that it wanted to convene its Appeals Review Panel (ARP) to fully consider these issues and “clarify the USPTO’s position.” Although the Director has authority to convene the ARP and set its membership, the default is for the panel to consist of the USPTO Director, Commissioner for Patents, and PTAB Chief Judge.

In its short order granting the remand, the Federal Circuit recognized that agencies generally have the right to request remand to reconsider previous positions. Although it would have been preferable to request remand prior to merits briefing, the court found no improper motive in the timing. Further, the court was convinced “that proceedings will be conducted expeditiously.”  This statement also serves as an implicit reminder to the Director that she should avoid undue delay in rehearing the case.

Xencor had noted that the remand may have an impact on its patent term adjustment, but the appellate panel found that argument “conjecture at this time and insufficient to override the benefits of remand here.”

This remand order adds to the growing procedural importance of the ARP as serving an important policy-setting role within the USPTO. It will be interesting to see whether the ARP continues focusing on biotech patents over the next couple of years. Of course, the Federal Circuit continues to give no deference to USPTO’s substantive interpretation of patentability standards at issue here.  So, if the USPTO maintains its position we’ll see another appeal with de novo review regarding the appropriate written description standard.  The next appeal may also include an APA challenge associated with using the appeal process to set USPTO policy.

On the merits, I expect that the USPTO will ultimately side with the patent applicant Xencor and loosen the written description requirement set forth in the original PTAB opinions. In any event, this will be an important case to follow that fits into broader questions about availability of patent protection for biotech innovations.

In re Xencor, 23-2048 (Fed. Cir. January 23, 2024) (remand order.)

Authored by Judge Prost and joined by Judges Lourie and Stoll.

The USPTO Application Number is 16/803,690.

Attorneys involved.

• Appellant Xencor, Inc. represented by William R. Peterson, Morgan, Lewis & Bockius LLP, et al.
• Appellee Katherine K. Vidal represented by Peter John Sawert, United States Patent and Trademark Office, et al.
• Amicus Curiae Professors represented by Jacob Sherkow, University of Illinois and Mark Lemley, Stanford University
• Amicus Curiae American Intellectual Property Law Association represented by Barbara A. Fiacco, Foley Hoag LLP, et al.
• Amicus Curiae Dana-Farber Cancer Institute, Inc. represented by Ronald E. Cahill, Barnes & Thornburg LLP, et al.