United States Court of Appeals for the Federal Circuit
2008-1459, -1476
MARTEK BIOSCIENCES CORPORATION,
Plaintiff-Cross Appellant,
v.
NUTRINOVA, INC.,
NUTRINOVA NUTRITION SPECIALTIES AND FOOD INGREDIENTS GMBH,
and LONZA, LTD.,
Defendants-Appellants.
Gregory A. Castanias, Jones Day, of Washington, DC, argued for plaintiff-cross
appellant. With him on the brief were Gidon D. Stern, of New York, New York, and
Samuel B. Abrams, Dechert LLP, of New York, New York.
George Pazuniak, Womble Carlyle Sandridge & Rice PLLC, of Wilmington,
Delaware, argued for defendants-appellants. With him on the brief were Oleh V.
Bilynsky, and Stephen J. MacKenzie.
Appealed from: United States District Court for the District of Delaware
Chief Judge Gregory M. Sleet
United States Court of Appeals for the Federal Circuit
2008-1459, -1476
MARTEK BIOSCIENCES CORPORATION,
Plaintiff-Cross Appellant,
v.
NUTRINOVA, INC.,
NUTRINOVA NUTRITION SPECIALTIES AND FOOD INGREDIENTS GMBH,
and LONZA, LTD.,
Defendants-Appellants.
Appeals from the United States District Court for the District of Delaware
in case no. 03-CV-896, Chief Judge Gregory M. Sleet.
_________________________
DECIDED: September 3, 2009
_________________________
Before NEWMAN, LOURIE, RADER, GAJARSA, and MOORE, Circuit Judges.
Opinion for the court filed by Circuit Judge GAJARSA, in which Circuit Judges NEWMAN
and MOORE join. Opinion dissenting in part filed by Circuit Judge LOURIE, in which Circuit
Judge RADER joins.
GAJARSA, Circuit Judge.
In this patent infringement action, Nutrinova, Inc.; Nutrinova Nutrition Specialties
and Food Ingredients GmbH; and Lonza, Ltd. (collectively “Lonza”) appeal from the final
judgment of the United States District Court for the District of Delaware that Lonza
infringed certain specified claims of Martek’s U.S. Patent Nos. 5,340,594 (“the ’594
patent”) and 6,410,281 (“the ’281 patent”). See Martek Biosciences Corp. v. Nutrinova
Inc., 520 F. Supp. 2d 537 (D. Del. 2007) (“Martek I”). Specifically, Lonza appeals the
district court’s denial of its motions for judgment as a matter of law (“JMOL”) that the
’594 patent claims are invalid and that Lonza does not infringe the ’281 patent claims,
the district court’s exclusion of its prior inventorship evidence, and the district court’s
construction of the claim term “non-chloride sodium salt.” Martek Biosciences Corp.
(“Martek”) cross appeals the district court’s grant of Lonza’s motion for JMOL that the
asserted claims of Martek’s U.S. Patent No. 6,451,567 (“the ’567 patent”) are invalid
and the district court’s construction of the claim term “animal” in Martek’s U.S. Patent
No. 5,698,244 (“the ’244 patent”). As to the points of error argued by Lonza on appeal,
we affirm. As to the points of error asserted by Martek on cross appeal, we reverse.
Background
I. The Technology and Patents
Docosahexaenoic acid (“DHA”) is an essential omega-3 fatty acid that plays an
important role in the development of organs such as the heart, brain, and eyes, and is
reported to have many additional health benefits. Because the human body produces
limited quantities of DHA, it is desirable to provide supplemental DHA.
Martek and Lonza make and sell DHA products. They obtain DHA by extracting
lipids from fermented microorganisms—specifically certain microalgae. The patents at
issue relate to specified microorganisms that are useful for the commercial production of
DHA because they produce high levels of DHA. Three of the patents at issue are
directed to “heterotrophic organisms and a process for culturing them for the production
of lipids with high concentrations of omega-3 highly unsaturated fatty acids (HUFA)
suitable for human and animal consumption as food additives or for use in
2008-1459, -1476 2
pharmaceutical and industrial products.” ’594 Patent col.1 ll.25–30; ’281 Patent col.1
ll.38–43; ’567 Patent col.1 ll.47–52. The ’594 patent claims a food product that contains
omega-3 and omega-6 HUFA produced by microorganisms of the genus
Thraustochytrium, the genus Schizochytrium, or a mixture of microorganisms from both
genera. ’594 Patent col.36 l.67–col.38 l.26. The ’281 patent claims methods for
fermenting (i.e., growing) microorganisms, including those of the Thraustochytrium and
Schizochytrium genera, using a medium containing a non-chloride sodium salt, which
reduces corrosion in the fermentor during fermentation of the microorganisms. ’281
Patent col.25 l.38–col.28 l.47. The ’567 patent claims a process for producing lipids by
extracting them from euryhaline microorganisms fermented under specified conditions.
’567 Patent col.27 l.26–col.28 l.34. The ’244 patent is directed to methods for
increasing the concentration of omega-3 HUFA in animals by feeding them
microorganisms of the order Thraustochytriales, which includes the Thraustochytrium
and Schizochytrium genera, or lipids extracted from such microorganisms. ’244 Patent
col.1 ll.21–23, col.8 ll.15–17, col.9 l.44–col.10 l.58.
II. Proceedings before the District Court
Before the district court, Martek asserted that Lonza infringes the ’594, ’281,
’597, and ’244 patents. Lonza asserted defenses of invalidity under 35 U.S.C. §§ 102,
103, and 112. The district court held a Markman hearing to construe the contested
claim terms. Based on the district court’s claim constructions, Martek stipulated that
Lonza does not infringe the ’244 patent and preserved its right to appeal the court’s
construction of “animal.” A jury trial followed. At trial, Martek argued that Lonza
infringes claims 1, 3, and 7 of the ’594 patent; claims 17, 31, 41, and 47 of the ’281
2008-1459, -1476 3
patent; and claims 1, 4, 5, 7, 10, 11, and 14 of the ’567 patent. Lonza argued that the
asserted claims of the ’567 and ’594 patents are invalid—specifically arguing that the
’567 and ’594 patent claims are invalid as anticipated and the ’567 patent claims are
invalid for lack of enablement. The jury found the asserted claims infringed and not
invalid. Moreover, the jury found that Lonza’s infringement of the ’281 patent claims
was willful. 1
Both parties filed post-trial motions. Lonza moved for JMOL that it does not
infringe the ’281 patent claims and that the ’594 and ’567 patent claims are invalid, and
Martek moved for a permanent injunction. The district court granted Lonza’s motion for
JMOL that the ’567 patent claims are invalid for lack of enablement and Martek’s motion
for a permanent injunction. Martek I, 520 F. Supp. 2d at 543, 558.
The parties timely appealed to this court. The district court had jurisdiction under
28 U.S.C. § 1338(a), and this court has jurisdiction over the appeals under 28 U.S.C.
§ 1295(a)(1). 2
1
More particularly, Martek asserted that two processes performed by Lonza
infringe the ’281 patent. The jury found that Lonza’s “Process #1” literally infringes the
’281 patent and that such infringement was willful. The jury found that Lonza’s “Process
#2” does not literally infringe the ’281 patent but does infringe under the doctrine of
equivalents. After trial, on Martek’s motion, the district court held that Process #2
literally infringes the ’281 patent as a matter of law. Martek I, 520 F. Supp. 2d at 547.
2
We heard this appeal as a five-judge panel pursuant to our statutory
authority under 28 U.S.C. § 46(b), which provides that the “Federal Circuit . . . may
determine by rule the number of judges, not less than three, who constitute a panel.”
See also Fed. Cir. R. 47.2(a) (“Cases and controversies will be heard and determined
by a panel consisting of an odd number of at least three judges, two of whom may be
senior judges of the court.”).
2008-1459, -1476 4
Discussion
On appeal, Lonza asserts that the district court erred by denying its motion for
JMOL that the ’594 patent claims are invalid as anticipated, by denying its motion for
JMOL that it does not infringe the ’281 patent claims, by excluding Lonza’s evidence of
prior invention by Dr. Long, and by construing the claim term “non-chloride sodium salt”
to include sodium hydroxide (NaOH). On cross appeal, Martek argues that the district
court erred by granting Lonza’s motion for JMOL that the ’567 patent claims are invalid
for lack of enablement and by erroneously construing the claim term “animal” to exclude
humans. We first address the issues raised by Lonza’s appeal and then turn to the
issues raised by Martek’s cross appeal.
I. Validity of the ’594 Patent Claims
Lonza moved for JMOL, asserting that the ’594 patent claims are invalid as
anticipated by WO 89/00606 and that substantial evidence does not support the jury’s
determination that WO 89/00606 is not prior art against the ’594 patent. The district
court denied Lonza’s motion. Martek I, 520 F. Supp. 2d at 551–53.
Here, we exercise plenary review over the district court’s ruling on a JMOL
motion, applying the same standard as was applied by the district court. Agrizap, Inc. v.
Woodstream Corp., 520 F.3d 1337, 1341–42 (Fed. Cir. 2008) (citing Gagliardo v.
Connaught Labs., Inc., 311 F.3d 565, 568 (3d Cir. 2002)). If the evidence is such that a
reasonable jury could find in favor of the non-movant, JMOL is inappropriate. See Fed.
R. Civ. Proc. 50(a). We may not substitute our view of the evidence or our credibility
determinations for those of the jury. See Agrizap, 520 F.3d at 1342.
2008-1459, -1476 5
The ’594 patent is a member of a family of patents, each of which claims priority
to an abandoned patent application filed in 1988, U.S. Ser. No. 07/241,410 (“the 1988
application”). “In order to gain the benefit of the filing date of an earlier application
under 35 U.S.C. § 120, each application in the chain leading back to the earlier
application must comply with the written description requirement of 35 U.S.C. § 112.”
Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997). “[T]he test for
sufficiency of support in a parent application is whether the disclosure of the application
relied upon ‘reasonably conveys to the artisan that the inventor had possession at that
time of the later claimed subject matter.’” Ralston Purina Co. v. Far-Mar-Co, Inc., 772
F.2d 1570, 1575 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir.
1983)). In other words, “the earlier application need not describe the claimed subject
matter in precisely the same terms as found in the claims at issue.” Tech. Licensing
Corp. v. Videotek, Inc., 545 F.3d 1316, 1331 (Fed. Cir. 2008). Whether the written
description requirement is met is a question of fact. Wang Labs., Inc. v. Toshiba Corp.,
993 F.2d 858, 865 (Fed. Cir. 1993). Thus, we will uphold the jury’s finding that the ’594
patent claims are adequately described by the 1988 patent application so long as that
finding is supported by substantial evidence in the record. See United States v. Coyle,
63 F.3d 1239, 1243 (3d Cir. 1995) (reviewing the jury’s factual determination for
substantial evidence). 3
3
Specifically, the jury determined that Lonza failed to prove by clear and
convincing evidence that the ’594 patent claims are not entitled to the benefit of the
priority date of the 1988 patent application, which pre-dates the allegedly anticipating
prior art offered by Lonza. Because the parties framed the relevant question regarding
priority as whether the 1988 application meets the written description requirement for
the ’594 patent claims, which is a question of fact, we review the jury’s priority verdict for
substantial evidence.
2008-1459, -1476 6
Lonza argues that substantial evidence does not support the jury’s finding that
the ’594 patent claims are entitled to the priority date of the 1988 application. The
parties limit their arguments to independent claim 1 of the ’594 patent. It reads:
A food product, comprising:
a) lipids extracted from a fermentation process for growing
microorganisms selected from the group consisting of microorganisms of
the genus Thraustochytrium, microorganisms of the genus Schizochytrium
and mixtures thereof, wherein said microorganisms are capable of
effectively producing lipids containing mixtures of omega-3 and omega-6
highly unsaturated fatty acids under conditions comprising:
i) salinity levels less salinity levels found in seawater;
ii) a temperature of at least about 15° C.; and
b) food material.
’594 Patent col.36 l.67–col.37 l.13. Lonza argues that the 1988 application fails to
provide the required written description for two limitations of that claim: (1) extracting
lipids from a mixed culture of fermenting/growing Thraustochytrium and Schizochytrium
cells and (2) combining the extracted lipids with a food material to make a food product.
Because substantial evidence supports the jury’s finding that the written description
requirement is met, we hold the district court did not err in denying Lonza’s JMOL
motion.
A. The mixed culture limitation
Lonza argues that substantial evidence does not support the finding that the
1988 application discloses the process of extracting lipids from a mixed culture of
fermenting Thraustochytrium and Schizochytrium microorganisms. We disagree. Dr.
Wang, Martek’s expert, explained how a person of ordinary skill in the art would
recognize that disclosure in at least one passage in the 1988 application. That passage
reads:
2008-1459, -1476 7
The unicellular fungal strains isolated by the method described readily
flocculate and settle, and this process can be enhanced by adjusting the
pH of the culture to pH <7.0. A 6-fold concentration of the cells within 1-2
minutes can be facilitated by this process. The method can therefore be
employed to preconcentrate the cells prior to harvesting, or to concentrate
the cells to a very high density prior to nitrogen limitation. Nitrogen
limitation (to induce higher lipid production) can therefore be carried out in
a much smaller reactor, or the cells from several reactors consolidated
into one reactor.
1988 Application at 23. First, Dr. Wang explained that the 1988 application discloses
unicellular fungal strains of the Thraustochytrium and Schizochytrium genera as useful
for practicing the invention. J.A. at 7635. Although the application discloses many
strains for use in the claimed invention, Dr. Barclay, the inventor of the patents in suit,
testified that almost all of the disclosed strains are of the Thraustochytrium or
Schizochytrium genus. J.A. at 7470–71. Thus, Dr. Wang explained that the disclosed
consolidation process, which is applicable to all “unicellular fungal strains isolated by the
method described,” 1988 Application at 23, describes the use of Thraustochytrium and
Schizochytrium strains in that process. J.A. at 7637.
Second, Dr. Wang explained that the statement that “cells from several reactors
[can be] consolidated into one reactor” describes the process of mixing strains of the
Thraustochytrium and Schizochytrium genera. He explained that the quoted passage
discloses the use of unicellular fungal “strains”—as in “more than one” strain—in the
described consolidation process. Id. Moreover, Dr. Wang testified that the quoted
passage, when considered in light of the entire application, discloses a process
comprising the following steps: (1) different strains are independently grown under
conditions optimized for each strain; (2) the cells from all strains are combined into one
reactor; and (3) nitrogen limitation is employed to increase the omega-3 fatty acid
content of the cells. Id. Thus, the text of the 1988 application, in light of Dr. Wang’s
2008-1459, -1476 8
testimony, provides substantial evidence to support the finding that the application
meets the written description requirement for the mixed culture limitation.
Lonza argues that the jury could not reasonably rely on Dr. Wang’s interpretation
of the text of the 1988 application. First, Lonza notes that the 1988 application contains
no working examples that consolidate cells from different strains. However, a patent
claim is not necessarily invalid for lack of written description just because it is broader
than the specific examples disclosed. See Bilstad v. Wakalopulos, 386 F.3d 1116, 1123
(Fed. Cir. 2004) (“‘We cannot agree with the broad proposition . . . that in every case
where the description of the invention in the specification is narrower than that in the
claim there has been a failure to fulfill the description requirement in section 112.’”
(quoting In re Smythe, 480 F.2d 1376, 1382 (CCPA 1973))); In re Rasmussen, 650 F.2d
1212, 1215 (CCPA 1981) (explaining that, in the context of written description, the fact
“that a claim may be broader than the specific embodiment disclosed in a specification
is in itself of no moment”); see also Tex. Instruments, Inc. v. Int’l Trade Comm’n,
805 F.2d 1558, 1563 (Fed. Cir. 1986) (“This court has cautioned against limiting the
claimed invention to preferred embodiments or specific examples in the specification.”).
Second, Lonza criticizes Dr. Wang’s testimony as “conclusory” and unsupported
by the text of the 1988 application. Appellant’s Br. at 27. We disagree. Dr. Wang
provided more than a mere conclusion that the 1988 application discloses the claim
limitations. He relied on specific statements in the 1988 application and explained how,
in his opinion, a person of ordinary skill in the art would understand those statements.
When the jury considered whether the 1988 application provides adequate written
description support for claim 1, it was required to consider how an ordinarily skilled
2008-1459, -1476 9
artisan would understand the text of the application, see PowerOasis, Inc. v. T-Mobile
USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008); In re Wertheim, 541 F.2d 257, 262
(CCPA 1976), and the jury was entitled to credit Dr. Wang’s opinion on that matter.
Finally, Lonza argues that Dr. Wang’s testimony cannot support the jury’s finding
because the 1988 application teaches away from the requirement of claim 1 that cells of
the Thraustochytrium and Schizochytrium genera be grown together, rather than simply
mixed together after each strain is grown in a separate reactor. We disagree. Neither
Dr. Wang’s testimony nor the text of the 1988 application indicates that strains of the
Thraustochytrium genus cannot be grown with strains of the Schizochytrium genus.
The application’s disclosure that Thraustochytrium strains respond more favorably to
phosphate than Schizochytrium strains, see 1988 Application at 20, does not teach that
Thraustochytrium strains could not or should not be grown together with Schizochytrium
strains. Likewise, the fact that the working examples disclose different preferred growth
conditions for Thraustochytrium cells as compared to Schizochytrium cells, see id. at
31–34, does not teach away from growing strains of the two genera together. In fact,
the application describes growth conditions generally suitable for all disclosed strains,
rather than specifically useful for any particular strain, see id. at 19–21, thus indicating
that the disclosed strains share growth attributes and may be cultured together.
Moreover, the jury could reasonably conclude that the portion of the 1988 application
relied upon by Dr. Wang discloses a mixed culture of growing Thraustochytrium and
Schizochytrium cells because neither Dr. Wang’s testimony nor the application itself
indicates that the growth process is completed prior to consolidation of the strains. See
id. at 23; J.A. at 7637.
2008-1459, -1476 10
Because substantial evidence supports the jury’s finding that the 1988
application adequately describes the mixed culture limitation of claim 1, the district court
did not err in denying JMOL.
B. The food product limitation
Regarding the food product limitation of claim 1, we also hold that substantial
evidence supports the jury’s finding that the 1988 application adequately describes
combining extracted lipids with a food material. The application discloses that “[t]he
cells can also be broken or lysed and the lipids extracted into vegetable or other edible
oil.” 1988 Application at 24. Dr. Wang explained that vegetable and edible oils are
understood to be “food materials,” and thus, the 1988 application discloses combining
the extracted lipids with food materials, as recited in claim 1. J.A. at 7634–35.
Moreover, the 1988 application discloses “the production of lipids with high
concentrations of omega-3 highly unsaturated fatty acids suitable for human and animal
consumption as food additives.” 1988 Application at 1 (emphasis added); see also id. at
6 (discussing the use of “omega-3 highly unsaturated fatty acids as a food additive”).
Thus, the text of the 1988 application, in light of Dr. Wang’s testimony, provides
substantial evidentiary support for the jury’s finding that the 1988 application meets the
written description requirement for the claimed food product comprising extracted lipids
and food material.
For the foregoing reasons, substantial evidence supports the jury’s finding that
the ’594 patent claims are entitled to the priority date of the 1988 application. Thus, the
district court did not err when it denied Lonza’s JMOL motion.
2008-1459, -1476 11
II. Infringement of the ’281 Patent Claims
All of the ’281 patent claims recite the following functional limitation: “the culture
medium containing the non-chloride sodium salt as the primary source of sodium results
in reduced fermentor corrosion compared to the culture medium containing sodium
chloride as the primary source of sodium.” ’281 Patent col.25 l.48–col.28 l.45. The trial
court construed that limitation to mean “the culture medium causes less chemical
wearing of the vessel in which the microorganisms are grown as compared to the level
of chemical wearing away to a vessel caused by a culture medium comprising sodium
chloride as the primary source of sodium.” Order Construing the Terms of U.S. Patent
Nos. 5,340,594; 5,698,244; 6,410,567; 6,451,456; and 6,607,900 at 2, Martek
Biosciences Corp. v. Nutrinova, Inc., No. 03-896 (D. Del. Dec. 12, 2005) (“Claim
Construction Order”). Lonza moved for JMOL, asserting that Martek failed to prove
infringement as a matter of law by failing to conduct comparative testing to demonstrate
that Lonza’s culture medium causes less chemical wear as compared to a culture
medium containing sodium chloride (NaCl) as the primary source of sodium. Because
substantial evidence supports the jury’s infringement verdict, we hold the district court
did not err when it denied Lonza’s motion.
A patentee may prove infringement by “any method of analysis that is probative
of the fact of infringement,” Forest Labs. v. Abbott Labs., 239 F.3d 1305, 1312 (Fed. Cir.
2001), and circumstantial evidence may be sufficient, Liquid Dynamics Corp. v.
Vaughan Co., Inc., 449 F.3d 1209, 1219 (Fed. Cir. 2006). To demonstrate that Lonza’s
accused process meets the functional claim limitation, Martek presented testimony from
two experts, each of whom concluded that Lonza’s culture medium—which contains
2008-1459, -1476 12
NaOH as the primary sodium source—causes less corrosion as compared to the
hypothetical culture medium—which contains NaCl as the primary sodium source. Dr.
Duquette, an expert in the field of corrosion, testified that Lonza’s process uses
fermentors made of 304-type stainless steel, which is highly susceptible to corrosion.
J.A. at 7681. Second, he explained that he need not conduct actual tests in order to
conclude that Lonza’s culture medium causes less fermentor corrosion than the
hypothetical medium because “the literature is quite clear” regarding the corrosive
effects of chlorides on stainless steels. J.A. at 7680. Moreover, Dr. Duquette
explained: “And it’s just not a rule of thumb, it’s a scientific fact that if you increase the
chloride concentrations in any aqueous medium as far as stainless steel is concerned,
you will cause more corrosion . . . .” J.A. at 7688.
Dr. Wang, Martek’s fermentation science expert, also testified that Lonza’s
process causes reduced corrosion as compared to the hypothetical medium. J.A. at
7306. He reviewed Lonza’s fermentation records and testified that he had calculated
the concentration of chloride ions present in Lonza’s culture medium as compared to
the concentration of chloride ions present in the hypothetical medium. J.A. at 7305–06.
He concluded that Lonza’s culture medium contains about one-third of the chloride ions
as the hypothetical medium. J.A. at 7306. Dr. Wang then explained that decreasing the
chloride content of the medium will cause less corrosion on 304-type stainless steel and
thus concluded that Lonza’s culture medium would be less corrosive than the
hypothetical medium. Id. Based on the testimony of Drs. Duquette and Wang, the jury
could have reasonably concluded that Lonza’s culture medium causes less chemical
2008-1459, -1476 13
wear as compared to a culture medium containing NaCl as the primary source of
sodium.
Our decision in Kim v. ConAgra Foods, Inc., 465 F.3d 1312 (Fed. Cir. 2006), is
not to the contrary. In that case, this court considered whether the district court
correctly granted JMOL of noninfringement of a “consisting essentially of” product claim
when the patentee failed to present “any examinations or tests of the actual accused
products.” Kim, 465 F.3d at 1320. Although the accused products contained all
claimed ingredients in the claimed amounts, id. at 1319, we explained that because the
claim at issue is a “consisting essentially of” claim, it is not infringed as a matter of law if
the accused products contain “additional, unclaimed ingredients that materially affect
the basic and novel properties of the invention.” Id. at 1319–20 (citing PPG Indus. v.
Guardian Indus. Corp., 156 F.3d 1351, 1354 (Fed. Cir. 1998)). Kim, a food chemist who
qualified as an expert, testified that the accused products necessarily infringe because
they include the same ingredients as her patented composition. Id. at 1320. ConAgra’s
expert disagreed, testifying that the accused products do not infringe because they
contain additional ingredients that affect functionality. Id. The jury found for Kim, but
we held that Kim’s testimony was insufficient to support the infringement verdict
because it was merely “conclusory testimony that the additional ingredients would not
have materially affected the pertinent characteristics of the bread” and “did not support
this determination with any examinations or tests of the actual accused products.” Id.
Thus, we held the district court did not err by granting JMOL of noninfringement
because Kim “presented no testimony based on the accused products themselves that
supported a finding of infringement.” Id.
2008-1459, -1476 14
The present case is unlike Kim. Martek did not rely on conclusory expert
testimony to demonstrate that Lonza’s medium reduces corrosion. As detailed above,
Martek presented testimony from two experts, each of whom conceptually analyzed the
accused process and testified that it must meet the functional claim limitation based on
the composition of Lonza’s culture medium and the known effects of chloride
concentration on stainless steel corrosion. Contrary to Lonza’s reading of Kim, we did
not articulate a general rule requiring one who alleges infringement of a claim containing
functional limitations to perform actual tests or experiments on the accused product or
method. Instead, we stated only that “Kim did not prove infringement because she
presented no testimony based on the accused products themselves that supported a
finding of infringement.” Id. Here, Martek presented expert testimony based on the
accused process that supports a finding of infringement.
Because Martek presented substantial evidence supporting the jury’s
infringement verdict, the district court did not err when it denied Lonza’s JMOL motion.
III. Exclusion of Lonza’s Prior Inventorship Evidence
The Patent Act provides that “[a] person shall be entitled to a patent
unless . . . before such person’s invention thereof, the invention was made in this
country by another inventor who had not abandoned, suppressed, or concealed it.”
35 U.S.C. § 102(g)(2). Lonza argues that the district court improperly excluded its
evidence that the claimed invention is not patent eligible because it was previously
made by another inventor, Dr. Long. Because Lonza sought to introduce the testimony
of an alleged prior inventor under § 102(g) for the purpose of invalidating a patent,
Lonza was required to produce evidence corroborating Dr. Long’s testimony. See
2008-1459, -1476 15
Finnigan Corp. v. Int’l Trade Comm’n, 180 F.3d 1354, 1367 (Fed. Cir. 1999) (“‘[T]he
case law is unequivocal that an inventor’s testimony respecting [the] facts surrounding a
claim of derivation or priority of invention cannot, standing alone, rise to the level of
clear and convincing proof.’” (quoting Price v. Symsek, 988 F.2d 1187, 1194 (Fed. Cir.
1993))); see also id. at 1369 (“[C]orroboration is required of any witness whose
testimony alone is asserted to invalidate a patent, regardless of his or her level of
interest.”).
We review evidentiary rulings under regional circuit law, except to the extent that
such rulings implicate substantive patent law. ATD Corp. v. Lydall, Inc., 159 F.3d 534,
548 (Fed. Cir. 1998). Here, we review the district court’s pretrial evidentiary ruling for
abuse of discretion. See Glass v. Phila. Elec. Co., 34 F.3d 188, 191 (3d Cir. 1994). “An
abuse of discretion arises when ‘the district court’s decision rests upon a clearly
erroneous finding of fact, an errant conclusion of law[,] or an improper application of law
to fact.’” NLRB v. Frazier, 966 F.2d 812, 815 (3d Cir. 1992) (quoting Int’l Union, UAW v.
Mack Trucks, Inc., 820 F.2d 91, 95 (3d Cir. 1987)). When determining whether an
alleged inventor’s testimony is sufficiently corroborated, we apply a rule-of-reason
analysis and consider all pertinent evidence. Sandt Tech., Ltd. v. Resco Metal &
Plastics Corp., 264 F.3d 1344, 1350 (Fed. Cir. 2001). The purpose of this corroboration
requirement is to prevent fraud, namely to “provide[] an additional safeguard against
courts being deceived by inventors who may be tempted to mischaracterize the events
of the past through their testimony.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157,
1170 (Fed. Cir. 2006). We note that Lonza “faces a particularly high hurdle in
attempting to demonstrate abuse of discretion in light of the stringent standard for
2008-1459, -1476 16
corroboration.” See Tex. Digital Sys. v. Telegenix, Inc., 308 F.3d 1193, 1218 (Fed. Cir.
2002). 4
To corroborate Dr. Long’s testimony that he had reduced the claimed invention to
practice prior to Martek’s date of invention, Lonza offered: (1) Dr. Long’s 1987
abandoned patent application and (2) evidence that the examples originally disclosed in
that abandoned application were later reproduced, generating the results described in
the application. On Martek’s pretrial motion, the district court excluded Lonza’s
proffered evidence based on its determination that the evidence could not sufficiently
corroborate Dr. Long’s testimony. J.A. at 7220. We hold that was not an abuse of
discretion.
The district court did not err when it determined that the proffered abandoned
patent application was insufficient to corroborate Dr. Long’s testimony. An alleged prior
inventor “must provide independent corroborating evidence in addition to his own
statements and documents,” Hahn v. Wong, 892 F.2d 1028, 1032 (Fed. Cir. 1989), such
as “‘testimony of a witness, other than [the] inventor, to the actual reduction to practice
4
In Texas Digital, we were considering whether the district court abused its
discretion when it excluded witness testimony regarding a prior use based on its
determination that the testimony could not be sufficiently corroborated. Although the
witness testimony at issue in the present case regards prior invention, as opposed to
prior use, the principles articulated in Texas Digital and related cases remain relevant to
our analysis because the corroboration requirement applies whether the witness claims
to be a prior inventor under § 102(g) or a prior user under § 102(a) or § 102(b). See
Finnigan Corp., 180 F.3d at 1367 (“[T]he case law is unequivocal that an inventor’s
testimony respecting facts surrounding a claim of derivation or priority of invention
cannot, standing alone, rise to the level of clear and convincing proof. No principled
reason appears for applying a different rule when other subsections of § 102 are
implicated: a witness’s uncorroborated testimony is equally suspect as clear and
convincing evidence if he testifies concerning the use of the invention in public before
invention by the patentee (§ 102(a)), use of the invention in public one year before the
patentee filed his patent (§ 102(b)), or invention before the patentee (§ 102(g)).”
(internal quotation marks and citation omitted)).
2008-1459, -1476 17
or . . . evidence of surrounding facts and circumstances independent of information
received from the inventor,’” id. at 1032–33 (quoting Reese v. Hurst, 661 F.2d 1222,
1225 (CCPA 1981). “Documentary or physical evidence that is made
contemporaneously with the inventive process provides the most reliable proof that the
inventor’s testimony has been corroborated.” Sandt Tech., 264 F.3d at 1350–51. Such
contemporaneous documentary evidence could include an abandoned patent
application. However, while an abandoned patent application is evidence of conception,
it is insufficient to corroborate testimony that an alleged prior inventor reduced the
invention to practice. See Tex. Digital, 308 F.3d at 1218 (holding the district court did
not abuse its discretion when it excluded testimony of a prior public use because an
unissued patent application was the only evidence of events prior to or
contemporaneous with invention); In re Schlittler, 234 F.2d 882, 885 (CCPA 1956),
overruled on other grounds by In re Borst, 342 F.2d 851, 854 (CCPA 1965) (stating that
abandoned applications may be “evidence of conception” but “furnish no evidence that
the processes or things they describe were ever made or used anywhere” (citation
omitted)); see also Singh v. Brake, 222 F.3d 1362, 1370 (Fed. Cir. 2000) (“[T]o
corroborate a reduction to practice, [we apply] a more stringent standard than that
required to corroborate a conception. Indeed, a notebook page may well show that the
inventor conceived what he wrote on the page, whereas it may not show that the
experiments were actually performed, as required for a reduction to practice.” (citation
omitted)); In re Costello, 717 F.2d 1346, 1350 (Fed. Cir. 1983) (“[A]n abandoned
application, with which no subsequent application was copending, cannot be considered
a constructive reduction to practice. It is inoperative for any purpose, save as evidence
2008-1459, -1476 18
of conception.”). Thus, the district court correctly determined that the 1988 application
could not sufficiently corroborate Dr. Long’s testimony as a matter of law.
Nonetheless, Lonza argues that an abandoned patent application may be
sufficient to corroborate an alleged prior inventor’s testimony under the law as
articulated in Sandt Technology and Smith v. Hall, 301 U.S. 216 (1937). We disagree
with Lonza’s reading of the case law. In the cases cited, the corroborating evidence
that was found to be sufficient was far more extensive than what Lonza has offered. In
each case, an abandoned patent application was offered in addition to other evidence
from a time prior to or contemporaneous with the alleged invention. In Sandt
Technology, four pieces of evidence were offered to corroborate the alleged inventor’s
testimony, including “other contemporaneous documents [i.e., other than the
abandoned patent application] to document the inventor’s testimony,” statements from
an uninterested witness, and “a great deal of physical evidence made
contemporaneously with [the] invention.” 264 F.3d at 1351–52. In Smith, the alleged
prior user’s testimony was “abundantly corroborated by disinterested witnesses and
contemporary photographs and publications describing it.” 301 U.S. at 228. Lonza
cites to no case, and we have identified no case, in which an abandoned patent
application alone was deemed sufficient to meet the corroboration requirement. The
only additional evidence offered by Lonza is a post hoc replication of experiments cited
in the abandoned application, which does not qualify as evidence from a time prior to or
contemporaneous with the alleged prior invention. Thus, we find Lonza’s argument that
it complied with the corroboration requirement as articulated in Sandt Technology and
Smith unpersuasive.
2008-1459, -1476 19
For the foregoing reasons, we hold the district court did not abuse its discretion
when it determined that Lonza could not corroborate Dr. Long’s testimony and thus
excluded Lonza’s evidence of prior inventorship. See Tex. Digital, 308 F.3d at 1218
(holding the district court did not abuse its discretion by excluding an alleged prior user’s
testimony for lack of corroboration when the only contemporaneous corroborating
evidence offered was an unissued patent application).
IV. Claim Construction of “Non-Chloride Sodium Salt”
Finally, Lonza also argues that the district court misconstrued the claim term
“non-chloride sodium salt,” as used in the ’281 patent, by allowing that term to
encompass sodium hydroxide (NaOH). We review assertions that the district court
legally erred in construing a claim term de novo. Cybor Corp. v. FAS Techs., Inc.,
138 F.3d 1448, 1456 (Fed. Cir. 1998) (en banc).
Because the district court’s claim construction comports with the intrinsic and
extrinsic evidence of record in this case, we affirm. First, although the ’281 patent
specification does not discuss NaOH, the prosecution history explicitly states that NaOH
is a non-chloride sodium salt, J.A. at 4329—a clear indication that the applicant used
the term “non-chloride sodium salt” in a manner broad enough to encompass NaOH.
Moreover, Martek presented extrinsic evidence to support its position. Specifically,
Martek produced two treatises, each of which teaches that NaOH can be considered a
salt. See Charles W. Keenan & Jesse H. Wood, General College Chemistry 121–22
(4th ed. 1971); Wesley E. Lingren, Inorganic Nomenclature: A Programmed Approach
114 (1980). In contrast, Lonza cites no evidence that NaOH cannot be considered a
salt. Although Lonza argues in its opening brief that NaOH cannot be considered a salt
2008-1459, -1476 20
because it is a base, Appellant’s Br. at 44, Lonza concedes in its reply brief that we
need not decide whether NaOH is technically a salt. Specifically, Lonza states:
Whether NaOH is . . . technically a ‘salt’ and whether the reaction product
of sodium and water can be considered a reaction of a sodium base and a
non-chloride acid are difficult scientific questions that need not be
considered, because the intrinsic record clearly excludes NaOH from the
scope of the claims. . . . [T]he critical issue is that the prosecution history
demonstrates that NaOH was excluded from the claims.
Appellant’s Reply Br. at 23–24.
Thus, Lonza’s primary argument on appeal is that Martek disclaimed coverage of
NaOH during prosecution of the application that issued as the ’281 patent. That
argument fails. To support its assertion, Lonza cites selected statements spanning two
pages of the prosecution history. Although the selected statements arguably support
Lonza’s assertion, those statements are undercut considerably by additional statements
recited in the same two pages of prosecution history relied upon by Lonza: (1) the
applicant’s explicit statement that NaOH is a non-chloride sodium salt, and (2) the
applicant’s statements distinguishing the prior art at issue from the claimed invention on
alternative grounds unrelated to the way NaOH was used in the prior art reference.
Thus, under this court’s precedent, Martek committed no clear and unmistakable
disavowal of claim scope. See, e.g., Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d
1314, 1325–26 (Fed. Cir. 2003) (“[F]or prosecution disclaimer to attach, our precedent
requires that the alleged disavowing actions or statements made during prosecution be
both clear and unmistakable.”); Bayer AG v. Elan Pharm. Research Corp., 212 F.3d
1241, 1252 (Fed. Cir. 2000) (“In determining whether there has been a clear and
unmistakable surrender of subject matter, the prosecution history must be examined as
a whole.”).
2008-1459, -1476 21
For these reasons, we uphold the district court’s claim construction.
V. Validity of the ’567 Patent Claims
Martek appeals the district court’s grant of JMOL that all asserted claims of the
’567 patent are invalid for lack of enablement. See Martek I, 520 F. Supp. 2d at 556–
58. Martek asserts that the district court erred by considering only the limitations of
independent claim 1 and failing to specifically address the additional limitations of
dependent claims 4 and 5. Martek asserts that the evidence of record supports the
jury’s verdict that claims 4 and 5 are enabled and that JMOL was thus inappropriate as
to those claims. We agree.
Claim 1 of the ’567 patent is directed to a process for extracting lipids from
euryhaline organisms having specified properties. Claim 1 reads:
A process for producing lipids comprising: (a) growing euryhaline
microorganisms in a fermentation medium, wherein said euryhaline
microorganisms are capable of producing about 1.08 grams per liter of the
fermentation medium per day of long chain omega-3 fatty acids per 40
grams of sugar per liter of the fermentation medium at a sodium ion
concentration in the fermentation medium of 60% seawater; and (b)
extracting lipids from said euryhaline microorganisms.
’567 Patent col.27 ll.28–37. Claims 4 and 5 are dependent on claim 1, with each claim
encompassing all limitations of claim 1 plus one additional limitation. Claim 4
additionally requires that the “euryhaline microorganisms are microorganisms of the
order Thraustochytriales.” Id. at col.28 ll.7–9. Claim 5 additionally requires that the
“euryhaline microorganisms are selected from the group consisting of Thraustochytrium,
Schizochytrium, and mixtures thereof.” Id. at col.28 ll.10–12.
Each issued patent claim is presumptively valid. 35 U.S.C. § 282. Here, Lonza
had the burden to prove by clear and convincing evidence that each asserted claim of
the ’567 patent is invalid. See Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir.
2008-1459, -1476 22
1988). To meet the enablement requirement, “the specification of a patent must teach
those skilled in the art how to make and use the full scope of the claimed invention
without undue experimentation.” ln re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)
(internal quotation marks omitted). “Whether undue experimentation is needed is not a
single, simple factual determination, but rather is a conclusion reached by weighing
many factual considerations.” In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). As we
have explained:
Factors to be considered in determining whether a disclosure would
require undue experimentation . . . include (1) the quantity of
experimentation necessary, (2) the amount of direction or guidance
presented, (3) the presence or absence of working examples, (4) the
nature of the invention, (5) the state of the prior art, (6) the relative skill of
those in the art, (7) the predictability or unpredictability of the art, and (8)
the breadth of the claims.
Id. “Enablement is a matter of law that we review without deference; however, this
Court reviews the factual underpinnings of enablement for substantial evidence.” Koito
Mfg. Co. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1149 (Fed. Cir. 2004). Regarding
claims 4 and 5 of the ’567 patent, the evidence of record supports the jury’s implicit
factual findings and ultimate verdict. Thus, we reverse the district court’s grant of JMOL
as to those claims.
In overturning the jury’s enablement verdict, the district court focused exclusively
on element (a) of claim 1, which is directed to growing euryhaline organisms that have
stated characteristics. See Martek I, 520 F. Supp. 2d at 556–58. The district court
relied primarily on the testimony of Dr. Ward, Lonza’s expert, who similarly considered
only element (a) of claim 1. J.A. at 7314–16. Dr. Ward testified that claim 1 potentially
covers very many—perhaps 10,000—euryhaline organisms, while the patent discloses
only one such organism in a working example. J.A. at 7615. Dr. Ward also stated that
2008-1459, -1476 23
the technology at issue here “involves a lot of unpredictability.” J.A. at 7616. When
asked to estimate “the quantity of experimentation that would be required to find a
euryhaline microorganism that would meet the claim limitations of Claim 1,” Dr. Ward
replied, “an enormous amount of research.” J.A. at 7615. Based on Dr. Ward’s
testimony, and in light of the fact that Martek presented no contradictory testimony, the
district court granted Lonza’s motion for JMOL and held the ’567 patent claims invalid.
The district court’s grant of JMOL was inappropriate because Lonza failed to
present any evidence—much less clear and convincing evidence—that one of ordinary
skill in the art must perform undue experimentation to practice claims 4 and 5. As
Martek correctly notes, dependent claims 4 and 5 are narrower than claim 1: claim 4 is
limited to euryhaline organisms in the order Thraustochytriales; claim 5 is limited to
euryhaline organisms of the Thraustochytrium or Schizochytrium genus. Lonza
presented no evidence of undue experimentation regarding those additional limitations.
Regarding claim 4’s additional limitation, the evidence indicated only that the
Thraustochytriales order contains at least all organisms of the Thraustochytrium and
Schizochytrium genera. J.A. at 7357–58. Regarding claim 5’s additional limitation,
another expert witness for Lonza, Dr. Porter, testified that the Thraustochytrium and
Schizochytrium genera together encompass only 22 known species. J.A. at 7549.
Thus, the evidence presented to the jury supports an inference that there are relatively
few potential species that may meet the limitations of claims 4 and 5, as compared to
the large number of potential species that may meet the limitations of claim 1. Dr.
Ward’s testimony—regarding the amount of experimentation necessary to select a
qualifying species from 10,000 possibilities—is far less relevant and persuasive when
2008-1459, -1476 24
considering the selection of a qualifying species from only 22 possibilities. Thus, the
evidence supports the jury’s implicit finding that one need not perform undue
experimentation to practice claims 4 and 5, as well as the jury’s ultimate conclusion that
Lonza failed to prove invalidity of those claims by clear and convincing evidence. For
these reasons, we reverse the district court’s grant of JMOL as to claims 4 and 5 of the
’567 patent.
VI. Claim Construction of “Animal”
All asserted claims of the ’244 patent are directed to methods for achieving high
concentrations of omega-3 HUFA in an “animal.” ’244 Patent col.1 ll.21–24, col.2 ll.17–
19, col.9 l.44–col.10 l.58. The district court construed the claim term “animal” to mean
“any member of the kingdom Animalia, except humans.” Claim Construction Order at 2.
Based on the court’s construction, Martek stipulated that Lonza does not infringe the
’244 patent claims, because neither Lonza nor its customers use the claimed methods
to provide omega-3 HUFA to non-human animals. See Stipulated Order Of Non-
Infringement at 1, Martek Biosciences Corp. v. Nutrinova Inc., No. 03-896 (D. Del. Apr.
21, 2006); Cross Appellant’s Br. at 9. Martek now appeals the district court’s claim
construction, arguing it is erroneous in light of the patent’s stated definition of “animal.”
We review such issues of claim construction without deference. See Cybor Corp., 138
F.3d at 1456. For the following reasons, we agree with Martek.
When a patentee explicitly defines a claim term in the patent specification, the
patentee’s definition controls. See Phillips v. AWH Corp., 415 F.3d 1303, 1321 (Fed.
Cir. 2005) (en banc) (“[T]he specification ‘acts as a dictionary when it expressly defines
terms used in the claims . . . .’” (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d
2008-1459, -1476 25
1576, 1582 (Fed. Cir. 1996)); id. at 1316 (“[O]ur cases recognize that the specification
may reveal a special definition given to a claim term by the patentee that differs from the
meaning it would otherwise possess. In such cases, the inventor’s lexicography
governs.”); see also Honeywell Int’l, Inc. v. Universal Avionics Sys. Corp., 493 F.3d
1358, 1361 (Fed. Cir. 2007) (“When a patentee defines a claim term, the patentee’s
definition governs, even if it is contrary to the conventional meaning of the term.”); 3M
Innovative Props. Co. v. Avery Dennison Corp., 350 F.3d 1365, 1374 (Fed. Cir. 2003)
(“Because 3M expressly acted as its own lexicographer by providing a definition of
embossed in the specification, the definition in the specification controls the meaning of
embossed, regardless of any potential conflict with the term’s ordinary meaning as
reflected in technical dictionaries.”). Here, Martek explicitly defined the term “animal” in
the ’244 patent: “The term ‘animal’ means any organism belonging to the kingdom
Animalia.” ’244 Patent col.5 ll.11–12. That definition controls. Thus, because it is
undisputed that humans are members of the kingdom Animalia, 5 it was error for the
district court to limit the claim term “animal” to exclude humans.
Lonza, however, argues that when the ’244 patent specification is considered in
its entirety, it clearly limits the claim term “animal” to non-human animals. See Phillips,
415 F.3d at 1313 (“Importantly, the person of ordinary skill in the art is deemed to read
the claim term not only in the context of the particular claim in which the disputed term
5
Lonza does not dispute that humans are members of the kingdom
Animalia. Indeed, the record contains evidence detailing the full hierarchical
classification of a human as follows—Kingdom: Animalia, Phylum: Chordata,
Subphylum: Vertebrata, Superclass: Tetrapoda, Class: Mammalia, Order: Primates,
Family: Hominidae, Genus: Homo, Species: Homo sapiens. Helena Curtis & N. Sue
Barnes, Invitation to Biology 240 (4th ed. 1985); see also Neil A. Campbell et al.,
Biology 723 (8th ed. 2008) (explaining that humans are mammalian primates in the
kingdom Animalia).
2008-1459, -1476 26
appears, but in the context of the entire patent, including the specification.”). For the
following reasons, Lonza’s arguments are unpersuasive.
First, the disclosure and enumeration of preferred non-human animals does not
constitute a clear and manifest disavowal of human animals. The ’244 patent states:
The term “animal” means any organism belonging to the kingdom
Animalia. Preferred animals from which to produce a food product include
any economic food animal. More preferred animals include animals from
which eggs, milk products, poultry meat, seafood, beef, pork or lamb is
derived. Milk products include, for example, milk, cheese and butter.
’244 Patent col.5 ll.11–17. Although the patent contemplates that certain animals are
“[p]referred animals from which to produce a food product,” that statement does not
disavow human animals because it relates to preferred embodiments only; it does not
state that all animals covered by the claims must produce a food product. As we have
explained:
[P]articular embodiments appearing in the written description will not be
used to limit claim language that has broader effect. And, even where a
patent describes only a single embodiment, claims will not be read
restrictively unless the patentee has demonstrated a clear intention to limit
the claim scope using words or expressions of manifest exclusion or
restriction.
Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1117 (Fed.
Cir. 2004) (citations and internal quotation marks omitted). Here, the patentee has used
no words or expressions that manifestly exclude coverage of humans, and thus, it would
be improper to override the patentee’s express definition of “animal” to limit the scope of
the claims. Moreover, the patentee’s use of modifying language to specify “[p]referred
animals” as “economic food animal[s]” ultimately supports a broad construction of the
2008-1459, -1476 27
unmodified term “animal” that includes non-food animals, such as humans. 6 In
summary, absent a clear intention to restrict the invention to particular members of the
kingdom Animalia, we cannot limit the claims to the listed preferred embodiments. See
id.
Second, contrary to Lonza’s assertions, the ’244 patent does not otherwise
contain language that can be fairly interpreted as a clear intention to disclaim coverage
of humans. See id.; Home Diagnostics, Inc. v. LifeScan, Inc., 381 F.3d 1352, 1358
(Fed. Cir. 2004) (“Absent a clear disavowal or contrary definition in the specification or
the prosecution history, the patentee is entitled to the full scope of its claim language.”).
For example, the fact that the claims refer to “raising” and “feeding” animals does not
clearly disclaim humans. Lonza cites no persuasive reason, and we can think of no
reason, why those two generic terms do not apply to human animals. Likewise, the fact
that some dependent claims are directed to certain types of animals—such as cows,
sheep, and goats—does not limit the scope of broader claims directed more generally to
“an animal.” In fact, the patent plainly contemplates that the invention is applicable to
6
The dissent focuses on statements in the patent that allegedly distinguish
between humans and other animals. See, e.g., ’244 Patent col.7 ll.51–54 (“[T]he whole-
cell biomass can be used directly as a food additive to enhance the omega-3 highly
unsaturated fatty acid content and nutritional value of processed foods for human intake
or for animal feed.” (emphasis added)). The dissent asserts that if the term “animal”
includes human animals, “[t]here would have been no need to distinguish between what
will be eaten by humans and what will be eaten by animals.” See Dissenting Op. at 4.
However, as noted here, if the general term “animal” encompasses only non-human
food animals, there would have been no need for the patentee to describe preferred
animals as “food animal[s].” The fact that the patentee chose to distinguish food
animals from other animals indicates that the general term “animal” encompasses non-
food animals, such as humans. And certainly, the isolated statements cited by the
dissent do not rise to the level of “a clear intention to limit the claim scope using words
or expressions of manifest exclusion or restriction,” Innova/Pure Water, 381 F.3d at
1117 (internal quotation marks omitted), as would be necessary to override the
patentee’s explicit lexicography.
2008-1459, -1476 28
humans. See, e.g., ’244 Patent col.7 ll.8–11 (“The purified omega-3 highly unsaturated
fatty acids can then be used as a nutritional supplement for humans, as a food additive,
or for pharmaceutical applications.”); id. at col.7 ll.42–45 (“As discussed in detail above,
the whole-cell biomass can be used directly as a food additive to enhance the omega-3
highly unsaturated fatty acid content and nutritional value of processed foods for human
intake or for animal feed.”); id. at col.7 ll.51–54 (“A further aspect of the present
invention includes introducing omega-3 HUFAs from the foregoing sources into humans
for the treatment of various diseases.”). Thus, we are “governed by the principle that
‘[a]bsent a clear disclaimer of particular subject matter, the fact that the inventor may
have anticipated that the invention would be used in a particular way does not mean
that the scope of the invention is limited to that context.’” Liebel-Flarsheim Co. v.
Medrad, Inc., 358 F.3d 898, 909 (Fed. Cir. 2004) (quoting Northrop Grumman Corp. v.
Intel Corp., 325 F.3d 1346, 1355 (Fed. Cir. 2003)). Under our precedent, because the
patent does not clearly disclaim coverage of humans, it would be erroneous to limit the
claims to certain types of animals that the inventor anticipated would prove useful in the
invention. That is especially true in the present case because the patent expressly
defines the claim term “animal” broadly enough to encompass humans and discloses
uses of the claimed invention applicable to humans.
Finally, Lonza asserts that the extrinsic evidence of record demonstrates that the
ordinary meaning of “animal” is a non-human animal. Appellant’s Reply Br. at 57. In
this case, because the patentee explicitly defined “animal,” Lonza’s extrinsic evidence is
simply irrelevant. See, e.g., Honeywell Int’l, 493 F.3d at 1361 (“When a patentee
2008-1459, -1476 29
defines a claim term, the patentee’s definition governs, even if it is contrary to the
conventional meaning of the term.”).
For the foregoing reasons, we hold that the district court’s claim construction is
erroneous. The proper construction for the claim term “animal” is the one explicitly
provided by the patentee: “any organism belonging to the kingdom Animalia,” which
includes humans. Thus, we reverse and remand for further proceedings under the
correct construction.
We have considered the parties’ remaining arguments, and we find them
unpersuasive.
Conclusion
We affirm the denial of Lonza’s JMOL motions asserting invalidity of the ’594
patent claims and noninfringement of the ’281 patent claims, the exclusion of Lonza’s
prior inventorship evidence, and the construction of the claim term “non-chloride sodium
salt.” We reverse the grant of JMOL of invalidity of claims 4 and 5 of the ’567 patent
and the court’s construction of the claim term “animal,” and we remand for further
proceedings consistent with this opinion.
AFFIRMED-IN-PART, REVERSED-IN-PART, and REMANDED
Costs
No costs.
2008-1459, -1476 30
United States Court of Appeals for the Federal Circuit
2008-1459, -1476
MARTEK BIOSCIENCES CORPORATION,
Plaintiff-Cross Appellant,
v.
NUTRINOVA, INC.,
NUTRINOVA NUTRITION SPECIALTIES AND FOOD INGREDIENTS GMBH,
and LONZA, LTD.,
Defendants-Appellants.
Appeals from the United States District Court for the District of Delaware
in Case No. 03-CV-896, Chief Judge Gregory M. Sleet.
LOURIE, Circuit Judge, with whom Circuit Judge RADER joins, dissenting in part.
I respectfully dissent from the majority’s conclusion that the district court erred in
construing the term “animal” in U.S. Patent 5,698,244 (“the ’244 patent”). I believe that
the district court properly construed the word “animal” in claim 1 to mean “any member
of the kingdom Animalia, except humans.” Martek Biosciences Corp. v. Nutrinova Inc.,
No. 03-896 (D. Del. Dec. 12, 2005).
Our precedents make clear that a patentee is free to be his own lexicographer.
See Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). To that
end, Martek argues, and the majority agrees, that it defined “animal” in a single line in
the ’244 patent: “The term ‘animal’ means any organism belonging to the kingdom
Animalia.” ’244 patent col.5 ll.11-12. Because humans are members of the Animalia
kingdom, Martek contends that the district court’s exclusion of humans from its claim
construction was in error.
This case illustrates the unusual situation in which a purported definition of a
claim term in the written description is totally negated by the remainder of the text of the
patent. Martek’s attempt at lexicography does not conform to the way in which it
otherwise describes its invention.
It is fundamental that we must read a claim term in a manner that comports with
the written description of the patent as a whole, see Markman v. Westview Instruments,
Inc., 517 U.S. 370, 389 (1996), and not simply with a single sentence, even one
purporting to be a definition, that is inconsistent with the remainder of the specification.
We have stated many times that the specification of a patent is the “single best guide to
the meaning of a disputed term,” and that the specification is to be viewed in its totality.
Vitronics, 90 F.3d at 1582; see Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir.
2005) (en banc) (“[T]he person of ordinary skill in the art is deemed to read the claim
term not only in the context of the particular claim in which the disputed term appears,
but in the context of the entire patent, including the specification.”); id. at 1315 (“The
specification is, thus, the primary basis for construing the claims.”) (quotation marks
omitted). Thus, rather than reading in isolation the single line in the specification that
Martek argues provides a definition of “animal,” one should review the entire patent to
determine the proper construction of the term. Having done so, it is clear that humans
should be excluded from the construction of the term “animal” in the ’244 patent.
Starting with the claims, claim 1, which is the only independent claim in the ’244
patent, reads, “A method of raising an animal, comprising feeding said animal material”
2008-1459, -1476 2
that contains omega-3 highly unsaturated fatty acids “in an amount effective to increase
the content of omega-3 highly unsaturated fatty acids in said animal.” Martek argues
that this language applies to humans, since children are “raised” in the sense that they
are “reared.” But, as demonstrated by the discussion below, the specification is not
directed to raising children; it is directed to raising non-human animals.
The Field of the Invention portion of the patent reads, “[t]he present invention
concerns a method for raising an animal having [ ] high concentrations of omega-3
highly unsaturated fatty acids (HUFA) and food products derived from such animals.”
’244 patent col.1 ll.21-24 (emphasis added). We have found that the use of the words
“the present invention” can be read to limit the invention to what is described as such.
See Honeywell Int’l, Inc. v. ITT Indus., Inc., 452 F.3d 1312, 1318 (Fed. Cir. 2006)
(discussing the patentee’s use of “this invention” and “the present invention” in the
specification). Food products are not derived from humans. Thus, because “the
present invention” concerns “food products” that come from “such animals,” the ’244
patent is directed to raising only those animals from which one can derive food
products. Accordingly, the Brief Summary of the Invention states that “[a]nimals raised
by the method of the present invention include poultry, cattle, swine and seafood, which
includes fish, shrimp and shellfish. The omega-3 HUFAs are incorporated into the flesh,
eggs and milk products.” ’244 patent col.2 ll.19-23.
It is true that the specification states, in one sentence, “The term ‘animal’ means
any organism belonging to the kingdom Animalia.” Id. col.5 ll.11-12. It is also true that
humans belong to the kingdom Animalia. However, the lines in the specification directly
2008-1459, -1476 3
following that sentence list a host of non-human animals from which one derives food or
milk:
Preferred animals from which to produce a food product include any
economic food animal. More preferred animals include animals from
which eggs, milk products, poultry meat, seafood, beef, pork or lamb is
derived. Milk products include, for example, milk, cheese and butter. . . .
Preferred animals for milk product production include milk-producing
animal, in particular cows, sheep, goats, bison, buffalo, antelope, deer and
camels. More preferred animals for milk product include cows, sheep and
goats.
Id. col.5 ll.12-29 (emphasis added). Humans are not economic food animals. Although
particular embodiments of a specification are generally not to be read into the claims,
see Specialty Composites v. Cabot Corp., 845 F.2d 981, 987 (Fed. Cir. 1988), the listing
of particular “food animal[s]” here strongly supports a conclusion that the term “animal”
encompasses only those animals raised for production of food and milk products,
thereby not including humans.
The next portion of the specification discusses how to incorporate materials
containing omega-3 HUFAs into animal feed. In contrast to the addition of those
materials to animal feed, the patent goes into detail about purifying omega-3 HUFAs
from microorganisms that “can then be used as a nutritional supplement for humans, as
a food additive, or for pharmaceutical applications.” ’244 patent col.7 ll.8-11. An even
more explicit distinction between humans and animals is made later in the specification:
“As discussed in detail above, the whole-cell biomass can be used directly as a food
additive to enhance the omega-3 highly unsaturated fatty acid content and nutritional
value of processed foods for human intake or for animal feed.” Id. col.7 ll.42-45
(emphasis added). There would have been no need to distinguish between what will be
eaten by humans and what will be eaten by animals if humans were included in the term
2008-1459, -1476 4
“animal.” Furthermore, in the same paragraph, the patent discusses the treatment of
“human” diseases, such as “cardiovascular diseases, inflammatory and/or
immunological diseases and cancer.” Id. col.7 ll.59-60. Again, if humans were included
in the term “animals,” there would be no reason to specify the treatment of humans,
since non-human animals also suffer from the same diseases.
Importantly, the fact that the milk or meat products of the animals subjected to
the method of the patent can be fed to humans does not mean that humans are among
the animals that are raised, according to claim 1, to yield milk or meat with high omega-
3 HUFA content. In other words, the majority fails to make a distinction between using
omega-3 HUFAs as a nutritional supplement for humans and animals, which is clearly
contemplated in the patent, and raising humans to be the source of such a nutritional
supplement, as human milk and meat with high concentrations of omega-3 HUFAs are
not used as nutritional supplements. Although women may produce milk, they are not
“raised” for that purpose.
We are bound to read a claim term in a manner that is consistent with the
specification as a whole. Having examined the use of the term “animal” in the claims
and the specification of the ’244 patent, I believe it is clear that one of ordinary skill in
the art would conclude that, despite the purported definition in the specification, the term
“animal” in the claims cannot include humans.
For the foregoing reasons, I respectfully dissent from the majority’s reversal of
the district court’s claim construction of “animal” in the ’244 patent. I otherwise join the
majority opinion.
2008-1459, -1476 5
Martek Biosciences Corp. v. Nutrinova, Inc.
Court: Court of Appeals for the Federal Circuit
Date filed: 2009-09-03
Citations: 579 F.3d 1363
Copy Citations