Section 112(a) Enablement and Written Description Issues in Life Science Cases: Leveraging CCPA and Federal Circuit Decisions

Description

Life science practitioners face 112(a) issues all the time, in examiner rejections during prosecution, patentability challenges in post-grant reviews (PGRs) before the PTAB, and validity challenges before the courts. Also, 112(a) written description support is required for entitlement to the priority date, so practitioners may find themselves facing 112(a) issues in inter partes reviews (IPRs) to either defend a priority date assertion of a patent claim or attack a priority date assertion of a reference raised by a petitioner. Furthermore, in motions to amend in post-grant proceedings, 37 CFR 42.121/42.221 requires patent owners to show support for any proposed substitute claims.

Potential written description issues include:

• Result without means of achieving it (hope vs. plan);
• Broad claim with little support in the specification, e.g., a genus claim with few or no species described in the specification;
• Unsupported claim limitations;
• Attempts to cherry-pick the original disclosure to claim narrow subject matter later discovered to be valuable;
• Substantial claim amendments made during prosecution;
• Priority chain support; and
• Could a POSITA conclude with "reasonable certainty" that patentee had "possession" of claimed invention?

Potential enablement issues include:

• Are claims objectively enabled?
• Routine vs. undue experimentation;
• Proper/improper use of post-filing evidence? (can only reflect state of the art at the time of filing);
• Priority date assertions;
• Claims enabled throughout scope?
• Any incorporation by reference issues?

The CCPA developed a rich body of Sect. 112 jurisprudence, which the Federal Circuit adopted as binding precedent, providing a treasure trove of arguments for practitioners. Counsel can draw on these CCPA cases, as well as PTAB and Federal Circuit cases, for guidance in presenting evidence and arguments of written description and enablement.

Listen as our authoritative panel of U.S. patent attorneys examines the lessons from recent Federal Circuit and PTAB decisions and select CCPA decisions to avoid repeating past mistakes and to promote the progress of the useful arts and sciences as mandated by the Constitution.