by Dennis Crouch
Since I have been writing about the pending appeal in In re Xencor, I thought I would keep readers updated on the briefing. I am interested in the case because of its focus on the written description requirements for Jepson and means-plus-function claims. As covered in previous posts (here and here), the patent applicant has appealed PTAB rulings that its biotech antibody claims lack sufficient written description support. The patent applicant and amici have filed merits briefs, but most recently the USPTO asked for remand so that it could reconsider its approach just days before its merits brief deadline. The basic issues:
- The Patent Act requires means-plus-function claims to be interpreted to cover corresponding structure disclosed in the specification and “equivalents thereof.” In its decision, the PTAB held that any equivalents must have written description support in the specification — or at least that the specification must provide guidance on what counts as an equivalent. Specifically, the PTAB stated “the inquiry for compliance with section 112(a) does not end” at one disclosed structure, and that equivalents under §112(f) require adequate written description support. Compliance “with the written description requirement of section 112(a) are not coincident nor fully satisfied by complying with section 112(f) for a claim in means-plus-function format.”
- Although the preamble of a Jepson claim is normally not given patentable weight for novelty/obviousness grounds, the PTAB held that the preamble still must be supported by sufficient written description in the original specification. “Thus, when the inventors claim their invention as ‘a method of treating a patient by administering an anti-05 antibody with an Fc domain,’ they have the statutory burden under the written description requirement of section 112(a) to describe such a method, including the treating aspect of the claim recited in the claim preamble.”
The patent applicant appealed both of these written description rejections to the Federal Circuit. And, rather than filing a brief in opposition, the USPTO has requested a remand to reconsider its position.
In its newly filed reply brief on the remand issue, the agency more clearly states that the newly created “Appeals Review Panel” will hear the case on remand in an attempt to set USPTO policy. The ARP was established earlier in 2023 as a replacement of the Precedential Opinion Panel process and designed to work alongside the Director Review process for IPRs. Although the Director can decide the constitution of each panel, the default panel will include the Director, the Commissioner for Patents, and the Chief Judge of the Patent Trial and Appeal Board. The newly filed reply brief indicate that the USPTO plans to use the ARP to “clarify the USPTO’s position on the proper analysis of Jepson-format and means-plus-function claims in the field of biotechnology and particularly in the antibody art.
The brief also provides a number of example cases where the Federal Circuit has remanded cases in somewhat similar situations — recognizing essentially that it is at the discretion of the court.
An interesting note here is that the USPTO admits that it currently does not know what its position should be on the issues being litigated:
The Director has not predetermined the outcome of [the potential ARP] review and thus is not presently in a position to state the decision of that panel, and the views of the USPTO, in its brief before the Court. The Director has only determined that convening the ARP is the best path forward to ensure careful review of the issues, and clear articulation of the USPTO’s views, in this significant area of the law.
Xencore USPTO Reply Brief on Remand. From Xencor’s position, this looks like the PTO wants an opportunity to reiterate its rejections in better form.
Although the USPTO does not currently know its position on the issues, I would recommend doing some planning since their merits brief is due December 8 and the Federal Circuit has not yet granted the remand.
One important issue raised by Xencor regarding remand of the appeal has to do with Patent Term Adjustment — and a suggestion that Xencor may suffer prejudice from the remand.
If this case were remanded, Xencor could lose 653 days and counting of patent term adjustment due to “C-delay” under 35 U.S.C. § 154(b)(1)(C)(iii), which seeks to compensate a patent applicant for time that an application has been in appellate review by the PTAB or a federal court. This potential loss of patent term would irreparably harm Xencor, an innovative company that, after great investment, has commercialized the claimed technology to the benefit of thousands of patients.
Xencor’s brief explains that PTA delay from appellate review requires a decision “reversing an adverse determination of patentability.” Chudik v. Hirshfeld, 987 F.3d 1033 (Fed. Cir. 2021) (citing 35 U.S.C. § 154(b)(1)(C)(iii)). In Chudik, the court held that the patentee receives no time for situations where no decision is issued (such as a remand).
In its response, the USPTO argued that these PTA expectations are too speculative to serve as considerations. In particular, even if Xencor wins the appeal, the USPTO has the power to reopen prosecution and raise other patentability issues. And, of course, Xencor might not win the appeal.