By Mark Chael —

In an
opinion by Circuit Judges Prost and Dyk handed down on December 29, 2006, the
U.S. Court of Appeals for the Federal Circuit held that the U.S.
District Court for the District of Arizona had incorrectly construed the claim term "dispensing" in U.S. Patent No. 6,352,861 (the '861 patent) as requiring "direct dispensing."  The CAFC, therefore, vacated the lower
court's judgment of non-infringement and remanded the case.  In dissent was Circuit Judge Lourie, who
agreed with the lower court's claim construction.

The '861 patent at issue in
this case claims
methods and related devices for performing various biological assays on
laboratory slides, including immunostaining, using bar code readers to identify
reagents and slides, as well as computers to coordinate the procedures.  On February 11, 2003, Ventana brought suit
against BioGenex alleging infringement of claims 1-3, 5, 6, and 8 of the '861 patent.  Following a Markman hearing
(Ventana Med. Sys., Inc. v. BioGenex Labs., Inc., No. 03-CV-92 (D. Ariz. 2005)), in which the District Court construed the claim term "dispensing"
to mean "direct dispensing," Ventana stipulated to non-infringement, reserving
its right to appeal the District Court's claim construction.

All of the
asserted claims of the '861 patent contain the term "dispensing" and the sole issue on appeal was the District Court's construction of that term to require "direct dispensing."  As construed by the District Court, "direct dispensing" means that a reagent is dispensed directly from a reagent container onto a
slide containing a specimen, without using an intermediate transport system to "sip" reagent from a reagent bottle and "spit" the reagent onto the slide.  According
to the District Court, the context of the term in the claims led to the narrow
interpretation, since the claims state that a reagent "in" a reagent container
is dispensed "onto" a slide.  The District Court also determined that a narrower construction was warranted in view of the written description and figures of the '861 patent, which disclose
embodiments in which reagents are dispensed from the bottom of reagent containers onto the
slides.  BioGenex also alleged that the
inventors had disclaimed indirect dispensing during the prosecution of related
patent applications.

The CAFC
reviewed the claim construction issue de novo (see Cybor Corp. v FAS Techs.,
Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc)) and determined that the ordinary
and customary meaning (see Phillips v. AWH Corp., 415 F.3d
1303 (Fed. Cir. 2005) (en banc)) of the claim term "dispensing" would not be limited to "direct
dispensing" by a person of ordinary skill in the art.  The CAFC disagreed with the District Court's reliance on the words "in" and "onto" in support of the narrowing interpretation to require "direct dispensing," stating that there is
nothing in the language of the claims to limit the term "dispensing."  The CAFC also did not agree with
BioGenex that certain general statements distinguishing the invention from the
prior art in the Background section of the '861 patent constituted a disavowal
of claim coverage by the inventors (see e.g., Honeywell Int'l., Inc. v. ITT Indus.,
Inc., 452 F.3d 1312 (Fed. Cir. 2006) and SciMed Life Sys., Inc. v. Advanced
Cardiovascular Sys., Inc., 242 F.3d 1337 (Fed. Cir. 2001).  In addition, the CAFC dismissed BioGenex's
allegation that since the disclosure only showed direct dispensing, the claims
should be so limited.  The CAFC has "repeatedly warned against confining the claims to [the specific] embodiments
[described in the specification]" (see Phillips, 415 F.3d at 1323).  Also, the CAFC noted that "each claim does not necessarily cover every
feature disclosed in the specification" and "[w]hen the claim addresses only
some of the features disclosed in the specification, it is improper to limit
the claim to other, unclaimed features."  Ventana, slip op. at 11, citing
Phillips at 1327; Golight, Inc. v. Wal-Mart Stores, Inc., 355 F.3d 1327, 1331
(Fed. Cir. 2004); and E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1370
(Fed. Cir. 2003).  Finally, the CAFC
dismissed BioGenex's allegations of prosecution history disclaimer because it was based on statements made in a
related application, stating that the doctrine "generally does not apply when the
claim term in the descendant patent uses different language."  Ventana, slip op. at 12, citing Invitrogen
Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1078 (Fed. Cir. 2005);
ResQNet.com, Inc. v. Lansa, Inc., 346 F.3d 1374, 1383 (Fed. Cir. 2003); and
Advanced Cardiovascular Sys., 265 F.3d at 1305-06.  Because the CAFC determined that the related applications upon which BioGenex relied in alleging prosecution history disclaimer used different claim language than the claims at issue, Ventana's statements during prosecution of its related application were not applicable
to the present case.

The case was remanded to the District Court for further proceedings in light of the CAFC's claim construction.

Additional Disclaimer:  MBHB was involved in the prosecution of the '861 patent.  To the extent that this case summary contains any opinions,
the opinions would be of Dr. Chael and not Ventana Medical Systems, Inc. or MBHB.