MARICAL INC et al v. COOKE AQUACULTURE INC et al

Filing 175

ORDER adopting in part 154 Report and Recommendations. By JUDGE JON D. LEVY. (akr)

UNITED STATES DISTRICT COURT
DISTRICT OF MAINE
MARICAL INC., et al.,
Plaintiffs,
v.
COOKE AQUACULTURE INC.,
et al.,
Defendants.

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1:14-cv-00366-JDL

ORDER ADOPTING IN PART THE RECOMMENDED DECISION ON
CLAIM CONSTRUCTION
The plaintiffs in this case, Marical Inc., Europharma AS, and Europharma Inc.
(Canada) (the “Plaintiffs”), have filed patent infringement claims against the
defendants, Cooke Aquaculture Inc., Cooke Aquaculture USA Inc., True North
Salmon Co. Ltd., True North Salmon US Inc., True North Sales US, Inc., and
Salmones Cupquelan S.A. (the “Defendants”).1 ECF No. 154 at 1. All parties are
engaged in the farming of salmon, which is a type of anadromous fish.2 Id. at 2.
The Plaintiffs allege that the Defendants produce and import salmon raised by
methods that infringe four patents: United States Patent No. 6,463,883 (Patent ‘883);
United States Patent No. 6,475,792 (Patent ‘792); United States Patent No. 6,481,379
(Patent ‘379); and United States Patent No. 6,564,747 (Patent ‘747). ECF No. 1 at 12.
1

The Defendants have filed a counterclaim for declaratory judgment of invalidity and non-infringement (ECF No.
16) that is not at issue in this order.
2

“Anadromous” means, in its zoological context, “[a]scending to rivers to spawn.” Oxford English Dictionary,
http://www.oed.com/view/Entry/6938?redirectedFrom=anadromous#eid.

The claim construction portion of the case was referred to the United States
Magistrate Judge, who filed a Recommended Decision (ECF No. 154) with the court
on July 6, 2016, pursuant to 28 U.S.C. § 636(b)(1)(B) and Federal Rule of Civil
Procedure 72(b). The Plaintiffs and the Defendants each filed an Objection to the
Recommended Decision on July 25, 2016 (ECF Nos. 163 and 164). The Defendants
filed their Response to Plaintiffs’ Objection (ECF No. 167) and the Plaintiffs filed
their Response to the Defendants’ Objection (ECF No. 168) on August 9. A hearing
on the parties’ objections to the Recommended Decision was held on August 11, 2016.
ECF No. 169.
I have reviewed and considered the Magistrate Judge’s Recommended
Decision, together with the entire record, and have made a de novo determination of
all matters adjudicated by it. I adopt the claim constructions recommended by the
Magistrate Judge, with the exception of the constructions discussed below.
I. BACKGROUND
As noted in the Recommended Decision, the grant of a patent is a grant of a
monopoly, in exchange for which the inventor is required to teach to others skilled in
the art, in clear and precise language, how to make, construct, and use the patented
invention. ECF No. 154 at 3 (citing 35 U.S.C. § 112; Gen. Elec. Co. v. Wabash
Appliance Corp., 304 U.S. 364, 368-69 (1938)). The requirement that the patentee
teach the invention in clear terms is known as the “definiteness requirement,”
Nautilus, Inc. v. Biosig Instr., Inc., 134 S.Ct. 2120, 2128 (2014), and provides notice
of the scope of the patent, Dow Chem. Co. v. Nova Chem. Corp. (Canada), 803 F.3d
620, 630 (Fed. Cir. 2015).
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Every patent must “conclude with one or more claims particularly pointing out
and distinctly claiming the subject matter which the inventor or a joint inventor
regards as the invention.”

35 U.S.C.A. § 112(b) (2016).

To be definite, terms

contained in the patent claim “must be precise enough to afford clear notice of what
is claimed, thereby apprising the public of what is still open to them.” Nautilus, 134
S.Ct. at 2129 (citation and quotation marks omitted).
II. CLAIM CONSTRUCTION
The initial stage in a patent infringement action—and the current stage of this
litigation—involves construction of the patent claim. Wavetronix LLC v. EIS Elec.
Integrated Sys., 573 F.3d 1343, 1354 (Fed. Cir. 2009).

“The purpose of claim

construction is to determine the meaning and scope of the patent claims asserted to
be infringed.” O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1360
(Fed. Cir. 2008) (citation and quotation marks omitted). The construction of patent
claims is a matter of law, though the construction of a claim term can have
“evidentiary underpinnings” that require subsidiary fact-finding. Teva Pharm. USA,
Inc. v. Sandoz, Inc., 135 S.Ct. 831, 835 (2015).
When construing claim terms, the court looks first to intrinsic evidence, which
is “the most significant source of the legally operative meaning of the disputed claim
language[,]” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996),
and which includes the patent claims themselves, the patent specification, and the
patent prosecution history, id. at 1582-83. The patent specification, in particular, has
been described by the Federal Circuit as “the single best guide to the meaning of a

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disputed term[,]” “[u]sually . . . dispositive,” and “always highly relevant[.]” Id. at
1582.
After considering intrinsic evidence, “a court may also seek guidance from
extrinsic evidence such as expert testimony, dictionaries, and treatises.” Suffolk
Techs., LLC v. AOL, Inc., 752 F.3d 1358, 1362 (Fed. Cir. 2014). However, extrinsic
evidence carries less weight in determining the operative language of claim language.
Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005).
A.

“Freshwater”
The Recommended Decision construes the term “freshwater” in Patents ‘379

and ‘792 to include specified ranges of calcium and magnesium in part 2 of the
definition. ECF No. 154 at 46 (“Water described in [part 1] to which has been added
calcium and/or magnesium to achieve concentrations in the range of between 2mM
and 10 mM calcium and between 0.5 mM and 10.0 mM magnesium.”).
The Defendants object to these ranges of calcium and magnesium, which were
not proposed by either party and do not appear in the specifications of Patents ‘379
and ‘792. Instead, the specifications state that freshwater has “less than about 2mM
of magnesium, calcium and NaCl[,]” and water “to which magnesium and calcium
have been added, as described herein.” ECF No. 1-4 at 4, col. 6, ll. 32-38 (Patent ‘792);
ECF No. 1-6 at 2, col. 5, ll. 52-58 (Patent ‘379).
The Recommended Decision’s construction of “freshwater” in Patents ‘883 and
‘747, on the other hand, contains no such specified ranges of calcium and/or
magnesium. ECF No. 154 at 46 (“Water described in [part 1] to which has been added
a PVCR modulator or more than one PVCR modulator.”). Adopting this construction
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for all four patents would more accurately reflect the patent specifications and would
resolve the Defendants’ objection.
For this reason, the definition of “freshwater” is construed for all four patents
as follows:
(1) Water from a freshwater source, such as water sourced from a stream,
river, pond, or another non-marine source, having, for example, the
following ionic composition: less than about 2 mM of magnesium,
calcium, and NaCl; and
(2) Water described in (1) to which has been added a PVCR modulator or
more than one PVCR modulator.
B.

“At least one PVCR modulator . . . in an amount”
The Recommended Decision construes this term, in pertinent part, to mean

“for example, additions of calcium and/or magnesium at the molar concentration
described in the specifications[.]” ECF No. 154 at 47.
The Defendants object to the Recommended Decision’s construction of this
term, arguing that it lacks reasonable certainty because the PVCR modulators listed
(i.e., “calcium and/or magnesium”) are examples only. ECF No. 164 at 14-15.

The

Defendants argue that the construction must disclose all PVCR modulators. Id.
As the Plaintiffs acknowledged at the hearing, the PVCR modulators and their
relevant amounts for purposes of the patents are identified in the patent
specifications. Therefore, deleting the words “for example” from the Recommended
Decision’s construction of the claim term provides greater certainty as to what PVCR
modulators are within the scope of the claim.
I therefore construe the term “At least one PVCR modulator . . . in an amount”
to mean the following:
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Additions of “at least one PVCR modulator … in an amount” means
additions of calcium and/or magnesium at the molar concentration
described in the specifications, as well as additions of other polycations
and amino acids in the concentrations indicated in the specifications.
The Defendants’ objection is denied in all other respects.
C.

“Significantly increased level”
The Recommended Decision construes the term “significantly increased level”

to be, in pertinent part, “a term of approximation, which term refers to the increase
in the PVCR modulator level in serum taught to result from the presence of NaCl in
fish feed in the [specified] amount. . . .” ECF No. 154 at 48.
The Defendants object to this construction because they claim that it fails to
identify the level of increase necessary to qualify as “significant.” ECF No. 164 at 16.
The Defendants made a substantially similar argument in their brief before the
Magistrate Judge.3 ECF No. 78 at 28.
The Plaintiffs argued to the Magistrate Judge that the term “significantly” is
not indefinite when read in light of the patents’ specifications, and that a person of
ordinary skill in the art would understand that “significance” is a statistical term
meaning p<0.05.

ECF No. 87 at 23-24 (“The disclosures in the patents-in-suit

unambiguously show that patentees selected a p-value of less than 0.05 as an
indicator of a ‘significant’ change in a measured level, including a significant increase
in the level of calcium in the serum of fish.”).

The Defendants also argue that the patents, more generally, are indefinite because “they give no
insight on what statistical analysis to perform,” ECF No. 78 at 30-31, and that “results can vary with
different types of statistical analyses[,]” id. at 32. While I acknowledge this argument, I make no
ruling on it because this order is limited to the issue of claim construction.
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I agree with the Defendants insofar as the term “significantly increased level”
should identify a standard by which to measure a “significant” level of increase in
PVCR modulator in the serum of fish. I agree with the Plaintiffs that this standard
is adequately identified by defining the term “significant” to mean having a p-value
of less than 0.05. Both the intrinsic and extrinsic evidence support this construction.
The supporting intrinsic evidence consists of the patent specifications, which
indicate that “significant” increases in serum calcium concentrations were those with
a p-value of less than 0.05. ECF No. 1-2 at 21, col. 39, ll. 26-28 (Patent ‘883); ECF
No. 1-4 at 21, col. 39, ll. 37-39 (Patent ‘792); ECF No. 1-6 at 16, col. 34, ll. 30-32
(Patent ‘379); ECF No. 1-8 at 32, col. 49, ll. 12-14 (Patent ‘747). The specifications for
Patent ‘747 also discuss “significant increases in enzyme activity” in the fish, with
“significant” defined as “p<0.05.” ECF No. 1-8 at 45, col. 76, ll. 57-58.
The extrinsic evidence supporting this construction includes the deposition of
the Defendants’ expert witness, Dr. Terence M. Bradley, Ph.D., who testified that use
of a p-value of less than 0.05 to denote statistical significance is common and that he
“typically” uses this standard himself. ECF No. 73-10 at 63. The extrinsic evidence
also includes the declaration of the Plaintiffs’ expert witness, Dr. Steven H. Jury,
Ph.D., which states that “[i]n the context of the patents, ‘significance’ refers to a
statistically significant increase, indicated by a p-value that is generally less than
0.05[.]” ECF No. 72 at 6, ¶ 18.
For the reasons discussed above, I construe the term “significantly increased
level” to mean the following:

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A statistically significant increase, indicated by a p-value that is less
than 0.05, in the concentration of calcium and/or magnesium in the
serum of pre-adult anadromous fish.
D.

“Person of Ordinary Skill in the Art”
The Recommended Decision construes the term “person of ordinary skill in the

art” to be one who, among other things, “has sufficient skill to conduct one or more
tests to measure PVCR expression in the tissue of fish and one or more tests to
measure PVCR modulator concentrations in fish blood.” ECF No. 154 at 45.
The Defendants object to this construction, arguing that a person of
ordinary skill in the art could not have conducted tests to measure PVCR sensitivity
at the time of the invention was patented because no such tests were available. ECF
No. 164 at 20. The Plaintiffs respond that the “hypothetical ‘person of ordinary skill
in the art’ is presumed to be familiar with tests used to measure gene expression and
receptor sensitivity, as such tests were known in the relevant art and described in
the patents.” ECF No. 168 at 10.
Both parties acknowledged at the August 11 hearing that a person of ordinary
skill in the art need not be able to actually conduct the test or tests, but rather, must
be able to understand the results of such tests. Given this acknowledgment, I adopt
the following construction of the term “person of ordinary skill in the art,” with the
italicized language being the only portion that differs from the Recommended
Decision’s construction:
The person of ordinary skill in the art is a person with, minimally, a
bachelor’s degree in the biological sciences, whose educational
background has been developed by managerial responsibility at a fish
hatchery that raises anadromous fish for transfer to seawater, who
understands the growth cycle of anadromous fish and the biological and
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chemical factors that produce osmotic stress in anadromous fish
following transfer to seawater, and who has familiarity with the
molecular techniques described in the patents.
III. CONCLUSION
It is therefore ORDERED that the Recommended Decision of the Magistrate
Judge (ECF No. 154) is hereby ADOPTED IN PART.

The recommended

constructions that are not adopted are construed in this order, as explained above.
SO ORDERED.
Dated this 2nd day of September 2016.
/s/ Jon D. Levy
U.S. DISTRICT JUDGE

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