incorportion : CAFC Alert

Incorporation by reference by its entirety without further relevant citation to specific contents is insufficient to provide intrinsic record to trump the disclaimer in the specification

| September 4, 2013

SkinMedica, Inc. v. Histogen Inc. et al.

August 23, 2013

Panel:  Rader, Clevenger, Prost.  Opinion by Prost.  Dissent by Rader.


SkinMedica owns the ’494 patent.  It filed a patent infringement suit against Histogen.  During the prosecution, the inventors limited their claimed inventions to pharmaceutical compositions comprising cell culture medium conditioned by animal cells cultured in three-dimensions.  The issue is whether the claimed term, “culturing … cells in three-dimensions,” covers the use of beads.  The ordinary meaning of the claimed term, “culturing … cells in three-dimensions” would cover the use of beads.  The court found that the inventors expressly defined the use of beads as culturing in two-dimensions.  Also, the inventors avoided anticipatory prior art during prosecution by asserting that the conditioned medium produced by two-dimensional cultures was inferior and chemically distinct from the conditioned medium produced by three dimensional cultures. SkinMedica also argued that the ’494 specification incorporates Doyle by reference, which explains the use of beads.  However, the court rejected this argument since specific reference to the relevant discussion is not made in the intrinsic record, which does not trump the disclaimer in the specification.

SkinMedica は494特許を所有しており、Histogen社を特許侵害で訴えた。494特許の審査段階において、出願人はクレーム発明を補正し、3次元培養に限定し た。争点は、クレーム発明がビーズの使用を含むかどうかである。クレーム用語である「細胞を3次元で培養する」の通常の意味は、ビーズの使用を含む。しか しながら、裁判所は、内部証拠から判断して、発明者が、ビーズの使用は2次元培養であることを明確に定義したと判断した。また、発明者は審査段階において 新規性拒絶をクリアするために2次元培養で製造した調整媒体は劣っており、3次元媒体で製造した調整媒体と化学的に区別できることを主張した、と判断し た。また、494特許は、ビーズの使用を説明した文献(Doyle)を明細書に引用していたが(incorporation by reference)、関連箇所を示す説明が何もないとして、SkinMedicaの主張を退けた。

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