United States Court of Appeals for the Federal Circuit
02-1203, -1257
ABBOTT LABORATORIES,
Plaintiff-Appellant,
v.
SYNTRON BIORESEARCH, INC.,
Defendant-Cross
Appellant.
Lee Carl
Bromberg, Bromberg & Sustein LLP, of Boston, Massachusetts, argued for
plaintiff-appellant. With him on the
brief were Joel R. Leeman and Eric Paul Belt. Of counsel on the brief were George C.
Lombardi, Winston & Strawn, of Chicago, Illinois; and Regina M.
Anderson, Office of the General Counsel, Abbott Laboratories, of Abbott
Park, Illinois.
David C.
Doyle, Morrison & Foerster LLP, of San Diego, California, argued for
defendant-cross appellant. With him on
the brief were Jill D. Neiman and Steven E. Comer. Of counsel was Peng Chen.
Appealed from: United
States District Court for the Southern District of California
Chief Judge Marilyn L. Huff
United States Court of Appeals for the Federal Circuit
02-1203, -1257
ABBOTT LABORATORIES,
Plaintiff-Appellant,
v.
SYNTRON BIORESEARCH, INC.,
Defendant-Cross Appellant.
___________________________
DECIDED: July 10, 2003
___________________________
Before
MAYER, Chief Judge, MICHEL and DYK, Circuit Judges.
DYK,
Circuit Judge.
Abbott Laboratories (“Abbott” or
“appellant”) appeals from the judgment of the United States District Court for
the Southern District of California that Syntron Bioresearch, Inc. (“Syntron”
or “appellee”) did not infringe the asserted claims of United States Patent
Nos. 5,073,484 (“the ‘484 patent”) and 5,654,162 (“the ‘162 patent”). Abbott Labs. v. Syntron Bioresearch, Inc.,
No 98-CV-2359 (S.D. Cal. Oct. 12, 2001) (“Judgment”). Syntron cross-appeals from the judgment that
the asserted claims are not invalid.
We affirm the judgment of
noninfringement as to claim 26 of the ‘484 patent and claims 1, 22, 29, and 30
of the ‘162 patent. We reverse the
judgment of non- infringement as to claims 22 and 23 of the ‘484 patent, and
remand as to those claims. We affirm the
judgment that the asserted claims are not invalid.
BACKGROUND
I
Abbott
is the exclusive licensee of the ‘484 and ‘162 patents (collectively “the
patents-in-suit), respectively entitled “Quantitative Analysis Apparatus and
Method” and “Chemical Analysis Apparatus and Method.” The written descriptions of the ‘484 and ‘162
patents are substantially identical, being generally directed to devices and
methods for performing chemical analysis.
The Field of the Invention sections of both patents described the
technical field disclosed in the patents as follows:
The invention
is in the field of quantitative chemical analysis, and is particularly useful
in the detection and analysis of small amounts of chemical substance in such
biological fluids as milk, blood, urine, etc.
‘484 patent, col. 1, ll. 10-13.[1]
The technology at issue involves
the reaction of three chemical constituents:
a substance to be detected (called an analyte, ligand, or antigen), a
substance that is complementary to and binds to the substance to be detected
(called a reactant or antibody), and an indicator (called a detector), which
also binds to the substance to be detected.
The patents are particularly directed to chemical analysis related to
the immune system and its reactions.
Proteins produced by the immune system bind to particular foreign
substances as a natural defense mechanism.
The technology at issue here exploits the ability of the immune system
to create proteins (antibodies or reactants) that bind with particularity to a substance
to be detected (ligand or analyte). The
indicator and the reactant bind to the analyte.
The reactant immobilizes the analyte, and the indicator provides an
indication of the presence of the analyte.
The indication can be one of two types, a qualitative indication or a
quantitative indication. Qualitative
analysis provides an indication of the presence or absence of the analyte in
the sample. A quantitative indication
provides information about the quantity of the analyte present in the test
sample. In the disclosed invention
quantitative analysis is performed using a device that includes a number of
analyte detection zones, wherein the number of zones in which analyte is
detected is directly proportional to the amount of analyte in the sample.
An exemplary embodiment of a test
device as shown in figure 5 of the ‘484 patent is reproduced below. The test device includes a test medium
comprised of a filter paper strip (40) that permits a liquid test sample to
flow downward therethrough. The test
medium contains reaction zones (40.1), which include therein reactant, bound to
the medium within the reaction zones. As
the test solution flows through the reaction zone, the reactant bound therein
reacts by binding with the analyte (if any) present within the test
sample. An indicator also reacts with
the analyte (e.g., by binding therewith), thus providing a “moiety
derived from [the] analyte, and desirably . . . a tagged or labeled form of the
analyte” called an “analyte derivative” that functions as an indication of the
presence of the analyte.
In operation, the liquid sample
is applied to the test strip and flows downward. The labeled or tagged analyte in the liquid
sample is trapped by the reactant in the test zones. The label or tag associated with the analyte
provides an indication of the analyte.
The number of zones within which analyte is indicated provides a
measurement of the concentration of the analyte within the liquid sample.
II
On December 30, 1998, Abbott
filed a complaint for patent infringement against Syntron alleging infringement
of both patents-in-suit and seeking damages and a permanent injunction. At trial the allegations of infringement were
narrowed to claims 22, 23, and 26 of the ‘484 patent (of which claims 22 and 26
are independent) and claims 1, 22, 29, and 30 of the ‘162 patent (of which
claims 1 and 22 are independent). Claim
22 of the ‘484 patent is exemplary of the asserted claims of that patent, and
provides:
A method for the analysis of an analyte which is a member of
a ligand-antiligand binding pair in a test solution comprising the steps of:
(a) providing a non-diffusively immobilized reactant in each
of one or more reaction zones spaced successively along a flow path defined by
a liquid permeable medium, wherein said reactant is the other member of said
binding pair and is capable of binding with the analyte to form a predetermined
product;
(b) flowing said solution along the medium and sequentially
through the reaction zone(s); and
(c) detecting the presence of analyte, said reactant or said
predetermined product in the reaction zone(s), wherein the number of zones in
which detection occurs is related to the persence of analyte in the solution.
Claim 1 of the ‘162 patent is
exemplary of the asserted claims of that patent, and provides:
A
device generating a signal indicative of the presence of an analyte in a liquid
solution suspected of containing said analyte, said device comprising:
(a)
a liquid permeable solid medium comprising a solution contact portion and one
or more spaced reactive zones separated from said contact portion;
(b)
a solution suspected of containing said analyte and having traversed said
medium, including said reactive zone(s);
(c)
a reactant non-diffusively bound to said medium only at said reactive zone(s),
said reactant being specific for and bound to said analyte or a reaction
product comprising said analyte and a chemical moiety; and
(d) a labeled antibody specific for and bound to said
analyte or said reaction product in said reactive zone(s); wherein said device
provides a detectable signal in said reactive zone(s) as an indication of the
presence or absence of said analyte in said solution.
On January 4, 2001, the district
court issued an order resolving disputed issues of claim construction. Abbott Labs. v. Syntron Bioresearch Inc.,
No. 98-CV-2359 (S.D. Cal. Jan. 4, 2001) (“Claim Construction Order”). On September 25, 2001, the district court
issued an order adopting supplemental claim constructions. Abbott Labs. v. Syntron Bioresearch Inc.,
No. 98-CV-2359 (S.D. Cal. Sept. 25, 2001) (“Supplemental Claim Construction
Order”). The constructions provided
in the supplemental order were used as the basis for the jury instructions as
to the claim terms “non-diffusively immobilized”; “non-diffusively bound”;
“specific for”; “predetermined amount”; and “analyte.”
On October 4, 2001, the jury
returned a special verdict form finding the asserted claims of the
patents-in-suit valid but not infringed.
Abbott Labs. v. Syntron Bioresearch Inc., No. 98-CV-2359 (S.D.
Cal. Oct. 4, 2001) (“Special Verdict”).
The jury found with respect to all of the asserted claims that Abbott
failed to prove that the accused products included a “non-diffusively
immobilized” or “non-diffusively bound” reactant. Id. at 1-3. The jury found that Abbott failed to prove
that the accused products included “a reactant bound [to the reaction zone]
which is specific for . . . the analyte” as recited claims 1, 22, 29, and 30 of
the ‘162 patent. Id. at 3. With respect to claim 26 of the ‘484 patent
and claims 22, 29, and 30 of the ‘162 patent, the jury found that Abbott failed
to prove that the accused products included “a predetermined amount of
reactant” in the reaction zone. Id.
at 2-3. The jury also found with respect
to claim 26 of the ‘484 patent that Abbott failed to prove that “detection
occurs . . . only if analyte is present in the test solution in a predetermined
amount.” Id. at 2. As to validity and enforceability, the jury
returned verdicts that Syntron failed to prove by clear and convincing evidence
that the claims were anticipated, obvious, invalid due to inventorship error,
lacked enablement or written description support, or were unenforceable due to
inequitable conduct. Id. at
4-7.
On October 12, 2001, the district
court entered judgment in favor of Syntron as to infringement and in favor of
Abbott as to validity and unenforceability in accordance with the special
verdict. Abbott Labs. v. Syntron
Bioresearch Inc., No. 98-CV-2359 (S.D. Cal. Oct. 12, 2001) (“Judgment”). Following judgment, Abbott and Syntron filed
motions for JMOL and a new trial, which were denied. Abbott Labs. v. Syntron Bioresearch Inc.,
No. 98-CV-2359 (S.D. Cal. Jan. 10, 2002) (“Order Denying JMOL”). Abbott filed a timely appeal of the final
judgment. Syntron filed a timely
cross-appeal. We have jurisdiction over
the appeal and the cross-appeal under 28 U.S.C. § 1295(a)(1).
DISCUSSION
We review the jury’s factual
determinations for substantial evidence.
Union Carbide Chems. & Plastics Tech. Corp. v. Shell Oil Co.,
308 F.3d 1167, 1177, 64 USPQ2d 1545, 1551 (Fed. Cir. 2002). This court reviews issues of claim
construction and the propriety of jury instructions without deference. Cybor Corp. v. FAS Techs., Inc., 138
F.3d 1448, 1456, 46 USPQ2d 1169, 1174 (Fed. Cir. 1998) (en banc). We review “[the] jury's conclusions on obviousness, a question of law,
without deference, and the underlying findings of fact, whether explicit or implicit
within the verdict, for substantial evidence.”
LNP Engineering Plastics, Inc. v. Miller Waste Mills, Inc., 275
F.3d 1347, 1353, 61 USPQ2d 1193, 1197 (Fed. Cir. 2001).
I.
Abbott requests review of the
jury findings as to four claim recitations:
“non-diffusively bound”; “non-diffusively immobilized”; “specific for”;
and “predetermined amount.” Abbott
argues that under the proper claim construction the judgment of noninfringement
cannot stand and that judgment of infringement should be entered in its favor
or, alternatively, a new trial should be granted.
We must sustain the judgment of
noninfringement as to an asserted claim if any one of the noninfringement
findings as to that claim is based on proper jury instructions and is supported
by substantial evidence. See Teleflex,
Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1328, 63 USPQ2d 1374, 1383
(Fed. Cir. 2002). Thus, in order to
prevail as to a particular claim, Abbott must establish as to each ground of
noninfringement that either (1) the jury instruction as to that element was
erroneous and prejudicial, Ecolab Inc. v. Paraclipse, Inc., 285 F.3d
1362, 1373, 62 USPQ2d 1349, 1356 (Fed. Cir. 2002), or (2) the jury verdict was
not supported by substantial evidence, Cybor, 138 F.3d at 1454, 46
USPQ2d at 1172.
A. Non-Diffusively Bound and Non-Diffusively
Immobilized
Abbott argues that the jury’s
finding of noninfringement based on the failure to satisfy the claim terms
“non-diffusively bound” and “non-diffusively immobilized” is not sustainable
because of error in the jury instruction.
All of the asserted claims
require a reactant that is either “non-diffusively bound” or “non-diffusively
immobilized.” The parties agree that
these recitations as properly construed have the same meaning. The district court adopted, and instructed
the jury using the following definition of “non-diffusively bound”:
Nondiffusively
bound means a reactant immobilized in the reaction zone so as to provide a
detectable signal indicating the presence or absence of analyte in the
solution, and the reactant is not capable of detaching from the medium,
spreading out, and moving along the test strip . . . . [A] reactant is
nondiffusively bound only if it is found in such a manner that a sufficient
and reproducible amount of reactant remains bound in the reactive zone or zones
to conduct both quantitative and qualitative assays.
(Tr. at X-132.) Abbott objected to the district court’s
construction, urging instead that the disputed recitations “require only that
the reactant be immobilized sufficiently to permit detection of the analyte in
the reaction zone.” (Appellant’s Br. at
25.).
On appeal Abbott urges that the
adoption of an instruction including the underscored language was error because
it interpreted the claim to require quantitative analysis. Syntron urges that the inclusion of the
“quantitative” language in the jury instruction was proper.
The first step in the analysis is
to determine the ordinary meaning of the claim terms. Tex. Digital Sys. v. Telegenix, Inc.,
308 F.3d 1193, 1202, 64 USPQ2d 1812, 1817 (Fed. Cir. 2002); see also
Inverness Med. Switz. GmbH v. Warner Lambert Co., 309 F.3d 1373, 1378,
64 USPQ2d 1933, 1936 (Fed. Cir. 2002); Vitronics Corp. v. Conceptronic, Inc.,
90 F.3d 1576, 1582, 39 USPQ2d 1573, 1576 (Fed. Cir. 1996). Dictionary definitions provide evidence of a
claim term’s “ordinary meaning.” Inverness,
309 F.3d at 1378, 64 USPQ2d at 1936. The
parties have conceded that the recitations “non-diffusively bound” and
“non-diffusively immobilized” are to be construed consistently. Starting with the words themselves,
“non-diffusively” is an adverb defining the verbs “immobilized” and
“bound.” Webster’s defines “bound” as
“held in chemical or physical combination : COMBINED.” Webster’s Third International Dictionary
260 (1968) (“Webster’s”).
Webster’s defines “immobilize” as “to make immobile : fix in place or
position : render incapable of movement.”
Id. at 1130. The plain
meaning of “immobilized” requires that the reactant not move relative to the
medium, and the recitation “bound” further defines how that immobilization is
provided, by requiring that the reactant be chemically or physically combined
with the medium so as to be immobilized.
“Diffusively” defines the degree
or character of the recitations “bound” and “immobilized.” “Diffusive”, the adverb form of which is
“diffusively”, means “having the quality of diffusing: tending to diffuse:
characterized by diffusion.” Id.
at 631. Webster’s defines diffusion as
“the process whereby particles (as molecules and ions) of liquids, gases, or
solids intermingle as the result of their spontaneous movement caused by
thermal agitation and in dissolved substances move from a region of higher
concentration to one of lower concentration.” Id. at 631 (emphasis added). Thus, a dissolved substance that moves
diffusively moves from a region of high concentration to one of lower
concentration within the liquid, i.e., disperses within the liquid.
Taking the words together, the
plain meaning of “non-diffusively bound” and “non-diffusively immobilized” is –
a chemical or physical combination of the reagent and the medium, such that the
reagent does not dissolve and move within the liquid from a region of high
concentration to a region of low concentration.
This definition closely mirrors the first portion of the construction
adopted by the district court – the reactant is not capable of detaching from
the medium, spreading out, and moving along the test strip – but bears no
resemblance to the underscored portion of the instruction. None of the pertinent dictionary definitions
supports the underscored portion. The
plain meaning of the claim recitation, therefore, does not support the district
court’s narrowing construction.
The usage of the disputed claim
terms in the context of the claims as a whole also informs the proper
construction of the terms. See RF
Del., Inc. v. Pac. Keystone Techs., Inc., 326 F.3d 1255, 1263-64, 66 USPQ2d
1593, 1598 (Fed. Cir. 2003). Here, the
language of the asserted claims suggests that quantitative analysis should not
be read as a requirement of the recitations “non-diffusively bound” or
“non-diffusively immobilized.” In claim
22 of the ‘484 patent, for example, element (c) requires “detecting the
presence of analyte.” Similar language
is found in each of the asserted claims. This language is broad enough to encompass
both qualitative and quantitative analysis, and therefore, militates against
the narrow definition used to instruct the jury. Syntron
appears not to argue to the contrary on appeal.
Rather, Syntron urges that the underscored language, in fact, broadens
rather than narrows the construction of “non-diffusively bound.” (Appellee’s Br. at 20.) According to Syntron, the jury instruction
did not require “quantitative analysis,” but rather defined the quality of binding
between the reactant and the test strip.
We cannot agree, as the language “sufficient and reproducible amount of
reactant remains . . . to conduct both quantitative and qualitative assays” is
an additional requirement beyond the ordinary meaning of the claim language.[2]
Thus, the construction adopted by
the district court and used to instruct the jury was erroneous insofar as it
included the underscored language requiring a sufficient amount to conduct
quantitative assays. Because we have
found that the jury was improperly instructed, and Syntron does not argue that
the instruction was harmless error, we cannot affirm the judgment of
noninfringement on the basis of the accused products’ not incorporating a
“non-diffusively bound” and “non-diffusively immobilized” reactant. Abbott urges that we enter JMOL in its favor
instead of ordering a new trial.
However, we think the issue of whether JMOL or a new trial should be
granted is an issue best addressed in the first instance by the district
court. Moreover, we must determine
whether the judgment of noninfringement as to any of the claims can be
sustained on other grounds.
B. Specific
For
The jury also found
noninfringement of claims 1, 22, 29, 30 of the ‘162 patent because it concluded
that the accused device did not meet the “specific for” claim recitation. Abbott urges that the district court’s construction
of “specific for” was in error, and that JMOL of infringement in its favor as
to those elements should have been entered or a new trial granted. Abbott urges that the jury instruction
included two errors, the inclusion of the language “particular to” in the
instruction and the failure to instruct the jury that the claim language “does
not mean that the reactant must bind only one analyte.” (Appellant’s Br. at 50-52.)
As to the first assigned error,
the inclusion of the language “particular to,” Abbott waived this argument by
agreeing to that portion of the adopted construction. The jury instruction for “specific for”
stated that the term meant “particular to and capable of binding with the
analyte or chemical moiety of interest.”
(Tr. at X-133.) The district
court further stated that “[p]articular to means capable of preferentially
reacting or binding with the analyte or chemical moiety from among the
thousands of molecules potentially in the test sample.” Id.
The disputed phrase was present in the proposed jury instructions
submitted by Abbott.[3] (J.A. at 8006.) Abbott also stated during trial “the Court
has defined [specific to] to mean particular to and capable of binding with the
analyte of interest, [a]nd the Plaintiff believes that that . . .
claim term is properly defined.” (Tr. at
VIII-212.) Abbott cannot wait until
after the jury returns a verdict against it and then on JMOL request a
different construction by attempting to have the district court delete a
portion of the construction that Abbott itself agreed to. See Interactive Gift Express, Inc.
v. Compuserve Inc., 256 F.3d 1323, 1345-46, 59 USPQ2d 1401, 1418 (Fed. Cir.
2001) (holding that the presentation of the adopted construction to the
district court constituted a waiver, precluding the party from proposing a new
construction either on JMOL or on appeal).
Abbott, therefore, cannot assign error to the district court’s use of a
definition including the language “particular to.” The jury in reaching its verdict was bound by
the district court’s instruction construing the claims. The jury was not charged with the task of
reaching a new claim construction through review of the sources used in
interpreting the claims such as dictionaries, the specification, or the
prosecution history.
Regarding the second error urged
by Abbott – the failure to instruct the jury that “‘particular to’ does not
mean that the reactant must bind only one analyte” – the instruction adopted by
the district court implicitly incorporated this portion of the proposed
instruction. Specifically, the jury
instruction stated that “[p]articular to means capable of preferentially
reacting or binding with.” (Tr. at
X-133) (emphasis added). The jury
instruction did not require that the reaction occur solely with the analyte,
but rather that the reaction with the analyte be the preferred reaction. Thus, the additional language urged by Abbott
was redundant of language that it also proposed and which the court used to
instruct the jury. There was no error,
therefore, in failing to instruct the jury that “‘particular to’ does not mean
that the reactant must bind only one analyte.”
In addition to errors in the jury
instruction, Abbott also argues that substantial evidence does not support the
jury verdict and that judgment of infringement is required under the district
court’s instruction. Even where a party
proposes the adopted instruction, that party is not estopped from arguing that
the jury failed to properly apply that instruction. Moba, B.V. v. Diamond Automation, Inc.,
325 F.3d 1306, 1314, 66 USPQ2d 1429, 1434 (Fed. Cir. 2003). In Moba the district court refused to
grant JMOL based on the jury’s implicit interpretation of the agreed-upon claim
construction. Id. On appeal, Moba argued that because Diamond
had agreed to the construction used to instruct the jury, it was estopped from
contesting the verdict. Id. This court reversed, holding that Diamond was
not so estopped because it was simply arguing that there was a lack of
substantial evidence to support the verdict under the district court’s own
instructions. Id. As the court explained, “Diamond [did] not
wish to alter the district court’s claim construction on appeal, but [sought]
enforcement of the trial court’s claim construction.” Id.
Here, under the district court’s
claim construction, the jury found that the accused devices did not include “a
reactant . . . which is specific for . . . the analyte.” The undisputed evidence showed that the
reactant employed in the accused devices binds identically to the analyte
(human chorionic gonadotropin - “hCG”) and to another protein called
luteinizing hormone (“LH”) that possesses an identical protein binding site to
that of hCG. Order Denying JMOL
at 23. The agreed upon claim
construction, however, required the reagent to be “capable of preferentially
reacting or binding with the analyte . . . from among the thousands
of molecules potentially in the test sample.” (Tr. at X-133.) The undisputed fact, as admitted by Abbott’s
own witness, is that the reactant employed by Syntron in the accused devices
binds identically with the analyte (hCG) and another substance
(LH). (Tr. at III-116). Thus, the jury could have reasonably
concluded that the reagent did not preferentially bind with the analyte
from among the thousands of molecules.
The issue here is solely whether the jury could have reasonably
concluded that the reagent did not meet the recitation as construed by the
district court in the instructions. We
conclude that it could have. On this
ground, therefore, we affirm the judgment of noninfringement as to claims 1,
22, 29, 30 of the ‘162 patent.
C. Predetermined Amount[4]
The jury found noninfringement of
claim 26 of the ‘484 patent, concluding that the accused device did not meet
the “predetermined amount” claim recitation.
The district court defined “predetermined amount” as “an amount
determined beforehand” and instructed the jury accordingly. (Tr. at X-133.) Abbott does not challenge the instruction as
such (having agreed to the instruction at trial), but for purposes of JMOL
seeks to interpret the claim language more broadly, i.e., “[t]he amount
of analyte or bound reactant need not be precisely known or reproducible.” (Appellant’s Br. at 37.) As we have discussed above, Abbott cannot
seek to modify an agreed claim construction on appeal. See Interactive Gift Express,
256 F.3d at 1345-46, 59 USPQ2d at 1418.
The jury found that the accused
devices did not include an “an amount determined beforehand” as required under
the construction adopted for this recitation.
Special Verdict at 2-3.
The district court refused to grant JMOL that Syntron infringed this
limitation. Order Denying JMOL at
28. As stated by the district court:
The record
suggests that the amount of bound antibody [in the accused devices] is unknown
and variable from test to test. . . .
Syntron’s manufacturing process merely involves placing the 1001 capture
antibody solution on the test strip, and “eyeballing” it to make sure that the
solution is on it.
Id. at 29. Based on this evidence the district court
concluded that a reasonable jury could have found that the amount of reactant
was not determined beforehand.[5] Id.
We agree with the district court that a reasonable jury could have found
that the amount of reagent was not determined beforehand. Thus, we affirm the judgment of
noninfringement as to claim 26 of the ‘484 patent.
D. Analyte
Syntron seeks to alternatively
support the judgment of noninfringement as to claims 22 and 23 of the ‘484
patent based on the argument that the district court’s construction of the
claim term “analyte” in those claims was erroneous, and that under the proper
claim construction no reasonable jury could have found that the limitation was
satisfied.
The district court construed
“analyte” to mean “the substance of interest, i.e., the substance that
the test is designed to detect if present in the liquid being tested.” Syntron objected to this construction before
the district court and urges on appeal that the district court should have instructed
the jury that the “analyte” limitation required quantitative analysis. Syntron does not argue that the plain meaning
of the word “analyte” requires quantitative measurement. Nor could it.
Although the word “analyte” is not defined in general dictionaries of
the English language, the term is used in specific fields of technology
including analytical chemistry, and within that field is defined as the
component of a sample that is to be determined.
See, e.g., Douglas A. Skoog et al., Fundamentals of
Analytical Chemistry 1 (7th ed. 1996) (“The components of a sample that are
to be determined are often referred to as analytes.”). This definition corresponds closely to the
definition adopted by the district court, that is, “the substance that the test
is designed to detect if present in the liquid being tested.”
The law is clear, however, that a
patentee may be his own lexicographer (see Renishaw PLC v. Marposs
Societa' per Azioni, 158 F.3d 1243, 1249, 48 USPQ2d 1117, 1121 (Fed. Cir.
1998)), and Syntron argues that Abbott did so here, defining analyte to require
quantitative analysis because the patentee explicitly defined the term in the
specification as “any chemical moiety which is to be measured
quantitatively.” (Appellee’s Br. at
40.). However, “[t]he patentee's
lexicography must, of course, appear ‘with reasonable clarity,
deliberateness, and precision’ before it can affect the claim.” Id. (emphasis added) (quoting In re
Paulsen, 30 F.3d 1475, 1480, 31 USPQ2d 1671, 1674 (Fed. Cir. 1994)). Thus, the issue is whether the patentee here
defined “analyte” with reasonable clarity, deliberateness, and precession. The definition cited by Syntron is provided
in the Summary of the Invention section of the patents-in-suit, and provides in
its entirety:
As used
herein, "analyte" refers not only to the particular chemical moiety
for which analysis is desired, but also to chemical moieties that are reaction
products of the moiety to be determined with another chemical moiety. For example, a biological fluid containing an
unknown amount of a chemical moiety may be reacted in solution or otherwise
with another chemical moiety to provide a product, the concentration of which
is related to the initial concentration of the chemical moiety to be
measured. The resulting product, then,
may become the "analyte" for use in the apparatus and method of the
invention. Accordingly,
"analyte" refers to any chemical moiety which is to be measured
quantitatively.
‘484 patent, col. 3, ll.
18-31.
We hold that the passage cited by
Syntron, taken in context, does not provide reasonable clarity, deliberateness,
and precision sufficient to narrow the definition of the claim term in the
manner urged. The first portion of the
cited passage defines the word “analyte” in terms of the “moiety for which
analysis is desired” and “reaction products of the moiety.” Id. at col. 3, ll. 18-22. This portion of the definition comports with
the district court’s definition of the word as the substance of interest. The last sentence provides a different
definition. Because the specification
provides two alternative definitions for the term at issue, the specification
does not define the claim term in the manner required under Renishaw. As correctly construed, therefore, the
ordinary meaning of “analyte” as used to instruct the jury is the proper
construction, and there is no basis for setting aside the verdict of
noninfringement of claims 22 and 23 of the ‘484 patent on this ground.
E. Doctrine of Equivalents
On August 20, 2002, Abbott filed
its reply brief on appeal, arguing for the first time that a new trial should
be granted on the issue of infringement under the doctrine of equivalents. Abbott bases this argument on the issuance of
the Supreme Court’s decision in Festo Corp. v. Shoketsu Kinzoku Kogyo
Kabushiki Co., 535 U.S. 722 (2002), rejecting the complete bar approach to
prosecution history estoppel adopted by our earlier decision in Festo Corp.
v. Shoketsu Kinzoku Kogyo Kabushiki Co., 234 F.3d 558, 56 USPQ2d 1865 (Fed.
Cir. 2000) (en banc). (Appellant’s Reply Br. at 17-19.) Abbott argues that it could not have addressed
this issue any earlier than May 28, 2002, the date of the Supreme Court’s
decision. Abbott was on notice that our
decision in Festo might be reversed by the Supreme Court, and was
obligated to present the issue if it wanted to have the benefit of the Supreme
Court’s decision.[6] Abbott has waived the doctrine of equivalents
argument by failing to raise it in its opening brief. Amhil Enters. Ltd. v. Wawa, Inc., 81
F.3d 1554, 1563, 38 USPQ2d 1471, 1477 (Fed. Cir. 1996) (stating that a reply
brief should “reply to the brief of the appellee” and “is not the appropriate
place to raise, for the first time, an issue for appellate review”) (internal
citation omitted).[7]
In summary, we affirm the
judgment of noninfringement as to claims 1, 22, 29, and 30 of the ‘162 and as
to claim 26 of the ‘484 patent. However,
remand is necessary as to claims 22 and 23 of the ‘484 patent on the issue of
infringement because of the erroneous claim construction.
II.
Syntron also cross appeals the
judgment that claims 22, 29, and 30 of the ‘162 patent are not invalid for lack
of written description, and that the asserted claims of the ‘484 patent are not
anticipated or rendered obvious by U.S. Patent No. 4,094,647 to Deutsch et al.
(“Deutsch”) issued June 13, 1978.[8] Even though we have sustained the judgment of
noninfringement as to some of these claims, we must nevertheless address the
issues of validity raised by the counterclaims in view of the Supreme Court’s
decision in Cardinal Chemical Co. v. Morton International, 508 U.S. 83,
93-94 (1993) (requiring a counterclaim of invalidity to be addressed without
regard to a determination of noninfringement).
At trial the burden was on
Syntron to prove by clear and convincing evidence that the written description
requirement of 35 U.S.C. § 112, ¶ 1, was not met. Compliance with the written description
requirement is a question of fact, which is reviewed for substantial
evidence. SunTiger, Inc. v.
Scientific Research Funding Group, 189 F.3d 1327, 1334, 51 USPQ2d 1811,
1815 (Fed. Cir. 1999). The dispute here
centers upon whether the disclosure, as originally filed, provided support for
the later added claim limitation “diffusively bound.” The district court construed this recitation
to mean “bound to the solid medium in such a way that the labeled antibody is
capable of detaching from the medium, spreading out, and moving along the test
strip.” (Tr. at X-131.) Abbott cites the following text from the ‘162
specification as providing the necessary written description support:
In a preferred
embodiment, only a single pass through the apparatus of a single liquid
material is required. An analyte may be mixed with an analyte derivative,
chromogen or other material and flowed through the apparatus to yield an
appropriate test result. In a further preferred embodiment, the apparatus is
chemically complete in that it includes all reactants and other chemicals
necessary or desirable for the quantitative analysis of an analyte; that is,
all that is required is that the analyte in a liquid carrier be flowed through
the apparatus. Elements of the apparatus that, if combined, would undergo
reaction in the absence of the analyte may be maintained in different zones.
For example, the bottom-most layer (20.2) of the strip of FIG. 2 may contain a
reactant physically separated from reactants in the adjacent reaction zone. When
the analyte in a carrier liquid is flowed through the layer (20.2), the
reactant in this layer together with the analyte and carrier liquid is flowed
into the first reaction zone. If desired, a reactant may be provided in the
form of a solid and may merely be placed upon the upper layer (18.4) of the
column of FIG. 1, the reactant being dissolved by and carried with the liquid
carrier and analyte into the column.
‘162 patent, col. 12, l. 62 -
col. 13, l. 15. Thus, the cited passage
teaches placing solid reactant on the upper layer of the test device to be
dissolved by the liquid carrier. An
expert witness for Abbott testified that in his opinion the claims of both
patents were properly fully supported.
(Tr. at II-156-57.) That
testimony, while brief, did provide substantial evidence supporting the jury
verdict. See Union Oil Co. v.
Atl. Richfield Co., 208 F.3d 989, 999, 54 USPQ2d 1227, 1234 (Fed. Cir.
2000). Moreover, all issued claims are
presumed valid. 35 U.S.C. § 282
(2000). The evidentiary burden,
therefore, was on Syntron and not Abbott.
Syntron failed to prove that, in light of the presumption of validity,
no reasonable jury could have decided that Syntron failed to prove by clear and
convincing evidence that the claims are invalid for failure to meet the written
description requirement.
Finally, as to the question of
the validity of the asserted claims of the ‘484 patent over Deutsch, that
reference was of record during the prosecution of both patents in suit. The presumption of validity remains the same
whether or not the art relied upon at trial was before the examiner. SIBIA Neurosciences, Inc. v. Cadus Pharm.
Corp., 225 F.3d 1349, 1355-56, 55 USPQ2d 1927, 1931 (Fed. Cir. 2000). However, the fact that a skilled examiner
passed upon that very reference during prosecution may be a factor in
determining whether the challenger has met the clear and convincing evidence
burden. Id.; Alco Standard
Corp. v. Tenn. Valley Auth., 808 F.2d 1490, 1497, 1 USPQ2d 1337, 1342 (Fed.
Cir. 1986).
With respect to anticipation
under 35 U.S.C. § 102, the dispute concerns whether Deutsch teaches “flowing
said solution along the medium” as required by the asserted claims. As described by Syntron, Deutsch teaches using
a “developing fluid” in addition to the sample solution to cause the solution
to flow. (Appellee’s Br. at 47.) The issue, therefore, is whether the
combination of developing fluid and test sample in Deutsch meets the claim
language “flowing said solution along the medium.”
The disputed claim language was
not separately addressed by the district court, nor did the parties request a
jury instruction concerning this language.
The jury instructions stated that the jury “should give any terms not
defined by [the court] their ordinary meaning.”
(Tr. at X-135.) Since Syntron did
not urge a particular claim construction of the disputed language before the
district court, it has waived the right to do so on appeal. We agree with Abbott that the jury could have
reasonably interpreted the language of the claims standing alone as requiring
that the solution itself provide the required flow. (Appellant’s Reply Br. at 23.) The burden having been on Syntron to prove by
clear and convincing evidence that the claims were anticipated, we cannot
conclude that the jury verdict on anticipation was not supported by substantial
evidence.
Syntron further argues that even
if the claims required that the solution itself provide the recited flow, the
claims as interpreted would be rendered obvious by Deutsch under 35 U.S.C. §
103. Syntron cites a statement by an
expert for Abbott that the use of the fluid sample to drive the flow was known
in the prior art. (Appellee’s Br. at
51.) Knowledge in the prior art of every
element of a patent claim, however, is not of itself sufficient to render claim
obvious. Graham v. John Deere Co.,
383 U.S. 1, 17-18 (1966); Teleflex, 299 F.3d at 1333-34, 63 USPQ2d at
1386. The issue is whether substantial
evidence supports the judgment (under the clear and convincing evidence
standard) that a person having ordinary skill in the art would not have been
motivated to replace the developing fluid/sample solution combination of
Deutsch with flow provided solely by sample fluid. Upon review of the evidence presented on the
issue of obviousness in view of Deutsch, and in view of the burden of proof, we
sustain the judgment of non-obviousness.
CONCLUSION
Thus, we affirm the judgment of
noninfringement as to claim 26 of the ‘484 patent and claims 1, 22, 29, and 30
of the ‘162 patent. We also affirm the
judgment on validity of all the asserted claims. Finally, we reverse the judgment of
noninfringement as to claims 22 and 23, and remand for further proceedings
consistent with this opinion.
AFFIRMED IN PART AND REVERSED AND
REMANDED IN PART
COSTS
No costs.