Because we agree with Merial that the district court
erred in its construction of two disputed claim terms, we
reverse the district court’s claim construction, vacate the
judgment of noninfringement, and remand for a finding of
whether the accused device infringes under the claim
construction articulated herein. Additionally, because we
agree with Merial that the district court misapplied the
law of prosecution history estoppel, we instruct the dis-
trict court to consider on remand arguments related to
literal infringement and to infringement under the doc-
trine of equivalents, consistent with the analysis herein.
There was a species-genus issue:
It is clear enough to us, however, that the patent
states that the five deposited strains and listed sequences
are “representative of” a “type of porcine circovirus,” and
thus do not constitute the entire scope of the invention.
’601 patent col.1 ll.60-61 (emphases added). Sequences
are representative of the scope of broader genus claims if
they indicate that the patentee has invented species
sufficient to constitute the genera. Enzo Biochem, Inc. v.
Gen-Probe, Inc., 323 F.3d 956, 967 (Fed. Cir. 2002); In re
Smythe, 480 F.2d 1376, 1383 (C.C.P.A. 1973). Here, the
deposited strains are representative species of the larger
“type II” genus, where the genus is identified and claimed
as the invention.
Claims properly directed to a genus may be ade-
quately supported by the patent disclosure if a sufficient
number of species is disclosed so as to properly identify
the scope of the genus. Id. Here, the patentee has dis-
closed five species of PCV-2, provided the full sequences
for four, and identified the potential coding portions of the
sequences. The patentee also provided a counterexample,
PCV-1, that by definition lies outside the scope of the
claimed genus, as well as a representative species of the
counterexample, its sequence, and potential coding por-
tions for the representative.
There was a doctrine of equivalents issue:
The district court found that prosecution history es-
toppel precluded Merial from invoking the doctrine of
equivalents. Merial was thus estopped from arguing that
the accused PCV strain was equivalent to the claimed
“porcine circovirus type II,” as that term was construed by
the district court.5 The district court erred, however, in
applying controlling Federal Circuit and Supreme Court
law to the prosecution history of the ’601 patent. As a
result, the scope of the district court’s bar on Merial’s
ability to invoke the doctrine of equivalents was overly broad.
Whether prosecution history estoppel applies to a par-
ticular argument, and thus whether the doctrine of
equivalents is available for a particular claim limitation,
is a question of law. Bai v. L & L Wings, Inc., 160 F.3d
1350, 1354 (Fed. Cir. 1998); Cybor Corp. v. FAS Techs.,
Inc., 138 F.3d 1448, 1460 (Fed. Cir. 1998) (en banc).
Where an amendment narrows the scope of the claims,
and that amendment is adopted for a substantial reason
related to patentability, the amendment gives rise to a
presumption of surrender for all equivalents that reside
in “the territory between the original claim and the
amended claim.” Festo Corp. v Shoketsu Kinzoku Kogyo
Kabushiki Co., 535 U.S. 722, 740 (2002) (Festo VIII). This
presumption can be overcome by showing that “at the
time of the amendment one skilled in the art could not
reasonably be expected to have drafted a claim that would
have literally encompassed the alleged equivalent.” Id. at
741. One way to make this showing is to demonstrate
that “the rationale underlying the narrowing amendment
bore no more than a tangential relation to the equivalent
in question.” Festo Corp. v. Shoketsu Kinzoku Kogyo
Kabushiki Co., 344 F.3d 1359, 1368 (Fed. Cir. 2003) (en
banc) (Festo IX). Although there is no hard-and-fast test
for what is and what is not a tangential relation, it is
clear that an amendment made to avoid prior art that
contains the equivalent in question is not tangential. See
Pioneer Magnetics, Inc. v. Micro Linear Corp., 330 F.3d
1352, 1357 (Fed. Cir. 2003).
The district court created an estoppel too large:
Such a draconian preclusion would be
beyond a fair interpretation of what was surrendered. Cf.
Festo VIII, 535 U.S. at 737-38. The rationale for the
amendment was to narrow the claimed universe of ORFs
down to those of PCV-2, and bore only a tangential rela-
tion to the question of which DNA sequences are and are
not properly characterized as PCV-2. Cf. Festo IX, 344
F.3d at 1369.
Within the dissent:
The question is whether the isolated DNA molecule,
separate from any applications associated with the iso-
lated nucleotide sequence (for example, the production of
a vaccine) is patentable subject matter. Neither the
Supreme Court nor this court has directly decided the
issue of the patentability of isolated DNA molecules.
Although we have upheld the validity of several gene
patents, see, e.g., In re Deuel, 51 F.3d 1552 (Fed. Cir.
1995); In re Bell, 991 F.2d 781 (Fed. Cir. 1993); Amgen,
Inc. v. Chugai Pharm. Co., Ltd., 927 F.3d 1200 (Fed. Cir.
1991), none of our cases directly addresses the question of
whether such patents encompass patentable subject
matter under 35 U.S.C. § 101.