Federal Circuit Remands to USPTO to Clarify Analysis of Jepson-Format and Means-Plus-Function Claims in the Field of Biotechnology

February 3, 2024

On January 23, 2024, the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) issued its decision granting the USPTO’s request to remand Xencor’s appeal of the rejection of U.S. Patent App.

The claims at issue in the ’690 patent application cover use of anti-C5 antibodies with an Fc domain.  The claims were drafted in both the “Jepson” and means-plus-function format (claims 8 and 9, respectively):

  1. In a method of treating a patient by administering an anti-C5 antibody with an Fc domain, the improvement comprising said Fc domain comprising amino acid substitution M428L/N434S as compared to a human Fc polypeptide, wherein numbering is according to the EU index of Kabat, wherein said anti-C5 antibody with said amino acid substitution has increased in vivo half-life as compared to said antibody without said substitutions.
  2. A method of treating a patient by administering an anti-C5 antibody comprising: a) means for binding human C5 protein; and b) an Fc domain comprising amino acid substitution M428L/N434S as compared to a human Fc polypeptide, wherein numbering is according to the EU index of Kabat, wherein said anti-C5 antibody with said amino acid substitution has increased in vivo half-life as compared to said antibody without said substitutions.

The examiner had rejected the claims as unpatentable (a) for failing to comply with the written description requirement, and (b) under the obviousness-type double patenting doctrine.  Xencor appealed the rejection to the Patent Trial and Appeal Board (“PTAB”), after which the examiner withdrew the written description rejection.

Related Articles

How Different Funds Approach Hurdle Rate Calculations

How Different Funds Approach Hurdle Rate Calculations

In a recent piece in this series, our colleagues showed that funds set hurdle rates differently depending on the asset class. Funds also use different approaches for calculating hurdle rates. Funds typically use one of three main approaches to calculate the hurdle:...