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

Shuji Yoshizaki | 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。


I.          BACKGROUND

SkinMedica owns the ’494 and ’746 patents.  In 2009, it filed a patent infringement suit against Histogen for producing dermatological products.

Original claims covered a pharmaceutical composition comprising any cell culture medium conditioned, including those cultured in either “two-dimensions” or “three-dimensions.”  The specification states the cells are cultured in monolayer, beads (i.e., two-dimensions).

During prosecution of the ’494 patent, the claims were amended into “three-dimensions.”  They did so to overcome an anticipation rejection based on prior art (the “Shipley” reference) that disclosed the use in a pharmaceutical composition of cell culture medium conditioned by animal cells grown in two-dimensions.

Claim 1 of the ’494 patent is representative:

1.         A method of making a composition comprising:

(a)        culturing fibroblast cells in three dimensions in a cell culture medium sufficient to meet the nutritional needs required to grow the cells in vitro until the cell culture medium contains a desired level of extracellular products so that a conditioned medium is formed;

(b)        removing the conditioned medium from the cultured cells; and

(c)        combining the conditioned medium with a pharmaceutically acceptable carrier to form the composition.

B.        District Court Proceedings

In May 2011, the District Court found that the inventors acted as their own lexicographers, construing the claimed phrase, “culturing…cells in three-dimensions” as excluding growing in monolayers or on microcarrier beads.

The district court stated, however, that it would have found otherwise if “the intrinsic evidence disclosed even a single reference to culturing cells in three dimensions using beads.”  To that point, SkinMedica had argued that Doyle was incorporated by reference in the written description provided such disclosure.  Doyle is a voluminous technical treatise that the written description states to be “incorporated by reference” in its “entirety,” without further relevant citation to specific contents.  The court concluded that the relevant discussion in Doyle was not identified with enough particularity to be adequately incorporated into the intrinsic record.

Following claim construction, Histogen moved for summary judgment on the infringement claims.  The district court granted Histogen’s motion.  SkinMedica filed an appeal of the district court’s grant of summary judgment.



In CAFC, SkinMedica argues that the district court’s claim construction is erroneous.  CAFC rejected SkinMedica’s arguments.  Terms are not always afforded their ordinary meaning.  In this case, the ordinary meaning of “culturing . . . cells in three-dimensions” would include the use of beads.  However, the question is whether the patentees excluded the use of beads.   To resolve this issue, CAFC analyzed the intrinsic record.  The ’494 patent refers to “beads” five times in the intrinsic record.  For example, the specification states:

Conditioned medium contains many of the original components of the medium, as well as a variety of cellular metabolites and secreted proteins, including, for example, biologically active growth factors, inflammatory mediators and other extracellular proteins. Cell lines grown as a monolayer or on beads, as opposed to cells grown in three dimensions, lack the cell-cell and cell-matrix interactions characteristic of whole tissue in vivo.

’494 patent col. 1 ll. 33–44 (emphasis added).  CAFC found that the inventors expressly defined the use of beads as culturing in two-dimensions.  The majority opinion concluded that it is clear from the intrinsic record that there was a clear implicit disclaimer of culturing with beads.

Judge Rader’s dissenting opinion, however, views that “as a monolayer or on beads” can be interpreted as a monolayer, or, as a monolayer on beads, which is not a clear disavowal of culturing …cell in three-dimensions.”

SkinMedica further argued that there was no disclaimer of using beads since Doyle is incorporated by reference.  According to SkinMedica, Doyle expressly discusses the use of beads to culture cells in three dimensions.”  CAFC disagreed.  When describing cell culturing methods, the inventors generally referred to Doyle, asserting that many methods of cell culturing were well known in the art.  CAFC sees no reason for such a non-specific reference to trump the clear disclaimer in the specification of culturing with beads.  See Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000) (discussing how a host document must “identify with detailed particularity what specific material it incorporates” to properly incorporate such material by reference).  CAFC concluded that Doyle does not define culturing with beads as “three-dimensional” and the inventors did not refer to Doyle for the purpose of defining what they meant by three-dimensional culturing.

CAFC affirmed the district court because the accused method employs beads, it cannot infringe the patent.


Take away    

If a term is used as non-ordinary meaning, the claims should recite any embodiments that Applicants do not want to disclaim.  If the claims had recited “use of beads,” the court would not have applied disclaimer for the term “three dimension.”

Full Opinion

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