Huvepharma EOOD et al v. Associated British Foods, plc et al

Filing 66

MEMORANDUM OPINION providing claim construction for multiple terms in U.S. Patent Nos. 6,451,572, 7,026,150, 7,312,063, 7,829,318, 8,455,232, and 8,993,300. Within five days the parties shall submit a proposed order consistent with this Memorandum Opinion suitable for submission to the jury. Signed by Judge Richard G. Andrews on 6/21/2019. Associated Cases: 1:18-cv-00129-RGA, 1:18-cv-00914-RGA(nms)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
HUVEPHARMA EOOD and
HUVEPHARMA, INC.,
Plaintiff,
V.

Civil Action No. 18-129-RGA
AS SOCIATED BRITISH FOODS, PLC, AB
VISTA, INC., PGP INTERNATIONAL
CORPORATION, ABITEX
CORPORATION, AB ENZYMES, INC.,
and AB ENZYMES GMBH,
Defendants.

HUVEPHARMA EOOD and
HUVEPHARMA, INC.,
Plaintiffs,

v.

Civil Action No. 18-914-RGA

E.I. DUPONT DE NEMOURS AND
COMPANY, DUPONT INDUSTRIAL
BIOSCIENCES, USA LLC, DANISCO USA
INC., and DANISCO US INC.,
Defendants.

MEMORANDUM OPINION
Jack B. Blumenfeld and Jeremy A. Tigan, MORRIS, NICHOLS, ARSHT & TUNNELL LLP,
Wilmington; DE; Robert Maier (argued), Jennifer C. Tempesta (argued), Michael E. Knierim,
Carolyn Pirraglia, and Yi Han, BAKER BOTTS LLP, New York, NY;
Attorneys for Plaintiffs (18-129).
Stephen B. Brauerman and Sara E. Bussiere, BAYARD, P.A., Wilmington, DE; Ajit Vaidya and
Ken Sheets, KENEALY VAIDYA LLP, Washington, DC;
Attorneys for Plaintiffs (18-914).

John C. Phillips, Jr. and David A. Bilson, PHILLIPS, GOLDMAN, MCLAUGHLIN & HALL,
P.A., Wilmington, DE; Kurt A. Mathas (argued) and Claire A. Fundakowski, WINSTON &
STRAWN LLP, Chicago, IL; Noorossadat Torabi, WINSTON & STRAWN LLP, Menlo Park,
CA;
Attorneys for Defendants Associated British Foods, PLC, et al.
Beth Moskow-Schnoll, Brittany M. Giusini, and Brian S.S. Auerbach, BALLARD SPAHR LLP,
Wilmington, DE; Robert R. Baron, Jr. (argued) and Marc S. Segal, BALLARD SPAHR LLP,
Philadelphia, PA; Alan White, BALLARD SPAHR LLP, Atlanta, GA;
Attorneys for Defendants E.I. Dupont de Nemours and Company., et al.

JuneiJ, 2019

2

AND~~
Presently before the Court is the issue of claim construction of multiple terms in U.S. Patent
Nos. 6,451,572 ("the '572 patent"), 7,026,150 ("the '150 patent"), 7,312,063 ("the '063 patent),
7,829,318 ("the '318 patent"), 8,455,232 ("the '232 patent"), and 8,993,300 ("the '300 patent").
The Court has considered the Parties' Joint Claim Construction Briefs. (C.A. No. 18-129, D.I. 62;
C.A. No. 18-914, D.I. 65). 1 At the parties' request, the Markman hearings in these actions were
combined. (D.I. 55). The Court heard oral argument on June 6, 2019. (Hr'g Tr.).

I.

LEGAL STANDARD
"It is a bedrock principle of patent law that the claims of a patent define the invention to

which the patentee is entitled the right to exclude." Phillips v. AWH Corp., 415 F.3d 1303, 1312
(Fed. Cir. 2005) (en bane) (internal quotation marks omitted). '"[T]here is no magic formula or
catechism for conducting claim construction.' Instead, the court is free to attach the appropriate
weight to appropriate sources 'in light of the statutes and policies that inform patent law.'"
SoftView LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips,
415 F.3d at 1324) (alteration in original). When construing patent claims, a court considers the
literal language of the claim, the patent specification, and the prosecution history. Markman v.
Westview Instruments, Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en bane), ajf'd, 517 U.S. 370
(1996). Of these sources, "the specification is always highly relevant to the claim construction
analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term."
Phillips, 415 F.3d at 1315 (internal quotation marks omitted).
"[T]he words of a claim are generally given their ordinary and customary meaning....
[Which is] the meaning that the term would have to a person of ordinary skill in the art in question

1

Unless otherwise stated, all docket item references in this opinion will refer to Civil Action No. 18-129.

1

at the time of the invention, i.e., as of the effective filing date of the patent application." Id at
1312-13 (citations and internal quotation marks omitted). "[T]he ordinary meaning of a claim
term is its meaning to [an] ordinary artisan after reading the entire patent." Id at 1321 (internal
quotation marks omitted). "In some cases, the ordinary meaning of claim language as understood
by a person of skill in the art may be readily apparent even to lay judges, and claim construction
in such cases involves little more than the application of the widely accepted meaning of
commonly understood words." Id at 1314.
When a court relies solely upon the intrinsic evidence-the patent claims, the specification,
and the prosecution history-the court's construction is a determination oflaw. See Teva Pharm.

USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015). The court may also make factual findings
based upon consideration of extrinsic evidence, which "consists of all evidence external to the
patent and prosecution history, including expert and inventor testimony, dictionaries, and learned
treatises." Phillips, 415 F.3d at 1317-19 (internal quotation marks omitted). Extrinsic evidence
may assist the court in understanding the underlying technology, the meaning of terms to one
skilled in the art, and how the invention works. Id Extrinsic evidence, however, is less reliable
and less useful in claim construction than the patent and its prosecution history. Id.
"A claim construction is persuasive, not because it follows a certain rule, but because it
defines terms in the context of the whole patent." Renishaw PLC v. Marposs Societa 'per Azioni,
158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would exclude
the inventor's device is rarely the correct interpretation." Osram GMBH v. Int'/ Trade Comm 'n,
505 F.3d 1351, 1358 (Fed. Cir. 2007) (citation and internal quotation marks omitted).

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II.

BACKGROUND
Plaintiffs Huvephanna EOOD and Huvephanna, Inc. brought suit against Defendants

Associated British Foods, PLC, AB Vista, Inc., PGP International Corporation, ABITEC
Corporation, AB Enzymes, INC., and AB ENZYMES GmbH ("the ABF Defendants") on January
23, 2018 asserting infringement of the '572 patent, the '15 0 patent, the '063 patent, the '318 patent,
the '232 patent, and the '300 patent ("the Asserted Patents"). (D.I. 1). Plaintiffs brought suit
against Defendants E.I. Du Pont de Nemours and Company, DuPont Industrial Biosciences USA,
LLC, Danisco USA, Inc., and Danisco US Inc. ("the DuPont Defendants") on June 20, 2018
asserting the' 150 patent, the '063 patent, and the '232 patent. (C.A. 18-914, D.I. 1). The Asserted
Patents share a common specification and are related to "a method of producing phytase in yeast
by introducing a heterologous gene which encodes a protein or polypeptide with phytase/acid
phosphatase activity into a yeast strain and expressing that gene." (' 150 patent, col. 2:57-60).
The parties have three common disputed terms. (D.I. 62 at 13, 52, 69; C.A. 18-914, D.I.
65 at 13, 51, 67). Plaintiffs and the ABF Defendants dispute an additional term in claims 8-9 of
the '300 patent. (D.I. 62 at 72). Plaintiffs and the DuPont Defendants dispute an additional term
in claims 1 and 28 of the '150 patent, claim 1 of the '063 patent, and claim 1 of the '232 patent.
(C.A. 18-914, D.I. 65 at 69). Claims 1 and 2 of the '150 patent and claims 1 and 6-8 of the '300
patent are representative.
Claims 1 and 2 of the '150 patent read as follows:
1. A method of producing phytase in yeast comprising:
providing a heterologous polynucleotide from non-yeast organism which encodes a protein
or polypeptide comprising either a PhyA phytase or an AppA phytase;
expressing the protein of polypeptide in a yeast; and

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isolating the expressed protein or polypeptide, wherein said protein or polypeptide
catalyzes the release of phosphate from phytate and has increased thermostability as
compared to that of said protein or polypeptide expressed in a non-yeast host cell.
2. The method according to claim 1, wherein the heterologous polynucleotide is an isolated
appA polynucleotide.
(' 150 patent, els. 1-2) (disputed terms italicized). Claims 1 and 6-8 of the '300 patent read as
follows:
1. A method of producing a phytase in fungal cells, the method comprising:
providing a polynucleotide encoding an Escherichia coli phytase;
expressing the polynucleotide in the fungal cells; and
isolating the expressed Escherichia coli phytase wherein the Escherichia coli phytase
catalyzes the release of phosphate from phytate.
6. The method of claim 1 wherein the fungal cells are cultured in a growth medium.
7. The method of claim 6 wherein the Escherichia coli phytase is secreted from the fungal
cells into the growth medium.
8. The method of claim 7 wherein the Escherichia coli phytase is purified.from the growth
medium.
('300 patent, els. 1, 6-8) (disputed terms italicized).

III.

CONSTRUCTION OF DISPUTED TERMS

1.

"a phytase from Escherichia coli'' I "Escherichia coli phytase" ('063 patent, cl. 1; '232
patent, els. 1, 3-4; '300 patent, els. 1, 7-9, 11-12)

a.

Plaintiffs' proposed construction: "any phytase derived from Escherichia coli"

b.

ABF Defendants' proposed construction: "a phytase isolated from wild type
Escherichia coli"

c.

DuPont Defendants' proposed construction: "the phytase encoded by the appA
polynucleotide (as defined below)"

d.

Court's construction: "any phytase derived from Escherichia coli"

Plaintiffs assert that Defendants' constructions of this term are contrary to the intrinsic
evidence and improperly narrow the claim scope. (D.I. 62 at 31-42, 40-41; C.A. 18-914, D.I. 65

4

at 19-21). Defendants argue that there is both lexicography and prosecution history disclaimer
that require this term to be construed in a narrow manner. (D.I. 62 at 20-24; C.A. 18-914, D.I. 65
at 22-26). The Du.Pont Defendants assert that the prosecution history disclaims any claim scope
beyond that of an AppA phytase. (C.A. 18-914, D.I. 65 at 24-26). The ABF Defendants propose
a slightly broader construction and argue that the claim language and specification support a claim
scope that only reaches phytase isolated from "wild-type" E. coli, meaning naturally-occurring E.

coli. (D.I. 62 at 13, 19).
First, the patentee did not act as a lexicographer in defining this term. "It is not enough for
a patentee to simply disclose a single embodiment or use a word in the same manner in all
embodiments, the patentee must 'clearly express an intent' to redefine the term." Thorner v. Sony

Comput. Entertainment Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). Here, the specification
does not "clearly express an intent" to redefine the term to be limited to AppA phytase. In fact,
the specification indicates that these terms should not be interpreted the same way; several
embodiments use the term "E. coli AppA phytase," rather than "AppA phytase" or "phytase from
E. coli." ('063 patent, col. 25:6-8; 26:29-30; 28: 19-21). Similarly, the specification does not

"clearly express an intent" to redefine the term to be limited to "wild-type" E. coli.
Second, I agree with Plaintiff that there is not prosecution history disclaimer. Defendants
assert that the patentee disclaimed all phytases other than the AppA phytase during prosecution of
the '150 patent and that the disclaimer should flow to the other patents, 2 which are children of the
'150 patent. (D.I. 62 at 21-22; C.A. 18-914, D.I. 65 at 21, 48-49). Even ifthere was disclaimer in
the '150 application, that disclaimer does not "flow" to the '062, '232 and '300 patents. The
prosecution history for the '063 patent makes clear that the applicant successfully traversed the

2

This does not include the '5 72 patent, which is the parent of the ' 15 0 patent.

5

examiner's written description rejection where it argued "that the disclosure of the AppA phytase
is sufficient to support all phytases from Escherichia coli." (C.A. 18-914, D.I. 66 at 417-18). After
the patentee made this argument, the examiner's written description objection was withdrawn, and
the claims were allowed. (C.A. 18-914, D.I. 66 at 433.009). Similar exchanges occurred in the
prosecution of the '232 patent (C.A. 18-914, D.I. 67 at 512-13, 517-18, 548) and the '300 patent
(id. at 560-61, 570-71, 590, 595 ("[T]he experiments reported in the present application using
AppA are representative of E. coli phytases generally and that the host strain does not significantly
alter the biochemical characteristics of the expressed phytase.")).
Third, the language of the claims themselves supports Plaintiffs' construction. Accepting
the DuPont Defendants' construction would cause claims 1 and 2 of the '232 patent to have the
same claim scope. The doctrine of claim differentiation "is based on the common sense notion
that different words or phrases used in separate claims are presumed to indicate that the claims
have different meanings and scope." Anderson Corp. v. Fiber Composites, LLC, 474 F.3d 1361,
1369 (Fed. Cir. 2007) (internal quotations omitted). While claim differentiation "can not broaden
claims beyond their correct scope," Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473,
1480 (Fed. Cir. 1998), the specification and prosecution history indicate that the terms
"Escherichia coli phytase" and "AppA phytase" are intended to have different meanings and
scope. Therefore, the claim language, the specification, and the prosecution history support
Plaintiffs' construction.
Thus, based on the intrinsic evidence, I construe the term "a phytase from Escherichia coli"
I "Escherichia coli phytase" to mean "any phytase derived from E. coli."

6

2.

"appA polynucleotide" ('572 patent, els. 1, 4-5; 9; '150 patent, els. 2, 28, 33-34, 39;
'318 patent, els. 1, 4-5)
a.

Plaintiffs' proposed construction: "any nucleotide sequence derived from an appA
gene of Escherichia coli that encodes a protein or polypeptide with phytase
activity"

b.

ABF Defendants' proposed construction: "the gene originally defined as E. coli
periplasmic phosphohydrolase gene, which contains 129[9] nucleotides and is
identified by GenBank accession number M58708"

c.

DuPont Defendants' proposed construction: "the polynucleotide having 1,299
nucleotides and corresponding to nucleotides 188 to 1486 of the appA gene of E.
coli (GenBank accession number M58708)"

d.

Court's construction: "any nucleotide sequence derived from an appA gene of
Escherichia coli"

Defendants assert that the term "appA polynucleotide" should be construed as the
polynucleotide identified by GenBank accession number M58708 because of lexicography and
prosecution disclaimer. (D.I. 62 at 58-60; C.A. 18-914, D.I. 65 at 56-58). Plaintiffs oppose this
narrow construction and argue that the patentee did not engage in lexicography or prosecution
disclaimer. (D.I. 62 at 53-56; C.A. 18-914, D.I. 65 at 63-64). Plaintiffs also argue that Defendants'
proposed constructions would read out preferred embodiments, specifically "Example 10" of the
patent specification. (C.A. 18-914, D.I. 65 at 55, 61).
The general rule of claim construction is that "[t]he words of a claim are generally given
their ordinary and customary meaning as understood by a person of ordinary skill in the art when
read in the context of the specification and prosecution history." Thorner v. Sony Comput. Entm 't

Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). Two exceptions exist: "l) when a patentee sets
out a definition and acts as his own lexicographer, or 2) when the patentee disavows the full scope
of a claim term either in the specification or during prosecution." Id
First, the patentee has not engaged in lexicography. "To act as its own lexicographer, a
patentee must clearly set forth a definition of the disputed claim term other than its plain and

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ordinary meaning." Id (internal citations and quotations omitted). To disavow claim scope, "[t]he
patentee may demonstrate intent to deviate from the ordinary and accustomed meaning of a claim
term by including in the specification expressions of manifest exclusion or restriction, representing
a clear disavowal of claim scope." Id. at 1366 (quoting Teleflex, Inc. v. Ficosa N Am. Corp., 299
F.3d 1313, 1325 (Fed. Cir. 2002)). Defendants point to the following sentences of the specification
as lexicography: "Another preferred heterologous gene is the appA gene of E. coli. The gene,
originally defined as E. coli periplasmic phosphoanhydride phosphohydrolase (appA) gene,
contains 1,29[9] nucleotides (Gen[]Bank accession number: M58708)." (' 150 patent, col. 5:666:2). However, this language does not "clearly set forth a definition of the disputed claim term."
CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). The GenBank

accession number M58708 contains entries for various mutants and variants, all referred to as an
appA gene. (C.A. 18-914, D.I. 67 at 605-07). Thus, there is no lexicography here.
Second, the patentee has not clearly disavowed claim scope beyond the GenBank
sequence. The specification repeatedly makes clear that the claimed method may require or use
a modified gene. See' 150 patent, col. 9:1-3 ("the present invention is not restricted to any
specific type of leader sequence or signal peptide"); col. 23 :9-10 ("to construct the signal peptide
of PhyA gene with the coding region of appA gene"); col. 23:62-66 ("Transforming INVScl with
the construct of p YES2-Sphy-appA (led by the signal peptide of PhyA) produced extracellular
phytase activity in the supernatant that was 2,000-fold greater than those of the wild type or of
the transformant containing appA gene plus its own signal peptide."). The adjustments or
modifications made in the patent occur within the 1,299 nucleotide sequence. (Id. at col. 23:910, 62-66). Thus, the specification clearly contemplates the use of a gene or polynucleotide that

8

does not contain the exact 1,299 nucleotide sequence disclosed in the primary entry of Genbank
accession number M58708.
Third, Plaintiffs' construction was not disclaimed in prosecution. Defendants point to
portions of the prosecution history where the examiner rejected claims under 35 U.S.C.

~

112 for

lack of written description as contradicting Plaintiffs' construction of this term. (C.A. 18-914,
D.I. 65 at 58),- The examiner objected to the scope of claims because the specification only
provided two representative species of "a heterologous polynucleotide from a non-yeast
organism," the appA polynucleotide and the phyA polynucleotide. (C.A. 18-914, D.I. 66 at 34041 ). The examiner found that these two polynucleotide species could not support all non-yeast
organism polynucleotides encoding proteins or polypeptides with phytase activity. (Id at 37677). In response, the patentee amended the claim to specify that the protein or polypeptide
encoded by the heterologous polynucleotide was "either a phyA phytase or an AppA phytase."

(Id at 387). However, this does not equate to a disclaimer of all possible appA polynucleotides.
Rather, it is only a clear disclaimer of the broader category of any polynucleotide from a nonyeast organism. Therefore, the patentee did not disclaim the claim scope covered by Plaintiffs'
construction.
'

Finally, the Example 10 embodiment provides further support for Plaintiffs' construction.
While the parties agree that claim 1 of the '150 patent contains a "providing" step and an
"expressing" step, they disagree as to which step the various subsections of Example 10 would
fall under. Plaintiffs argue that the "providing" step of the claimed method encompasses the
following subsections of Example 10: Gene and Protein(' 150 patent, col. 22:36-61); Host and
Vector (id at col. 22:62-64); and Construction of the Expression Vector (id at col. 22:65-23:23).
Under Plaintiffs' reading of the claim and specification, only the "Expression" subsection of

9

Example 10 (Id at col. 22:24-29) would fall under the "expressing" step of the claim. Therefore,
Plaintiffs argue, the Defendants' construction of"appA polynucleotide" would read out Example
10, an embodiment of the claims. Defendants disagree. They argue that the "Host and Vector"
I

and "Construction of the Expression Vector" subsections fall under the "expressing" step of the
claim, rather than the "providing" step. Therefore, Defendants argue, their construction of
"appA polynucleotide" does not read out this embodiment.
Regardless of how Example 10 is read as to which activity is characterized as the
providing step and which is the expressing step, it indicates that the invention encompasses more
than just the 1,299 nucleotide sequence identified at Genbank accession number M58708. A
person of ordinary skill in the art thus would understand after reading the specification that
"appA polynucleotide" refers to the sequences (including mutants and variants) found at
Genbank accession number M58708 as well as other modified polynucleotides which code for
phytase activity. Therefore, I construe "appA polynucleotide" to mean "any nucleotide sequence
derived from an appA gene of Escherichia coli."

3.

"AppA phytase" / "Escherichia coli AppA phytase" / "E. coli AppA phytase" ('150
patent, cl. 1; '232 patent, cl. 2; '300 patent, cl. 2)
a.

Plaintifft' proposed construction: "any phytase derived from an appA gene of
Escherichia coli"

b.

ABF Defendants' proposed construction: "a phytase isolated from wild type
Escherichia coli encoded by the appA polynucleotide"

c.

DuPont Defendants' proposed construction: "the phytase encoded by the appA
polynucleotide (as defined above)"

d.

Court's construction: "any phytase encoded by an appA polynucleotide"

Plaintiffs argue that the specification and prosecution history do not support Defendants'
narrow constructions. (D.I. 62 at 69-70; C.A. 18-914, D.I. 65 at 67-68). Defendants assert that

10

the specification and prosecution history require a narrow construction of the term, though they
differ on the purported scope of the term. (D.I. 62 at 70-71; C.A. 18-914, D.I. 65 at 68-69).
The parties agree that an "AppA phytase" as described in the claims has a clear relationship
to an "appA polynucleotide" as used in the claims. The parties' dispute mirrors the previous term
"appA polynucleotide." (D.I. 62 at 69-71). For the reasons explained above, I do not find there
to be lexicography or disclaimer requiring or supporting Defendants' narrow constructions.
However, Plaintiffs' use of "derived from" to describe the relationship between the phytase and
the polynucleotide is not supported by the specification or claim language. The specification
repeatedly makes clear that the overexpression of the AppA phytase is the result of the coding
sequence in the appA polynucleotide. ('150 patent, col. 2:58-60; 3:12-14; 5:12-14, 51-52; 10:912, 22-23). Therefore, "encoded by" is a more accurate description of the relationship between
the phytase and the polynucleotide. Thus, I construe the term "AppA phytase" to mean "any
phytase encoded by an appA polynucleotide."
4.

"purified from the growth medium" ('300 patent, els. 8-9)

a.

Plaintiffs' original proposed construction: Plain and ordinary meanmg, e.g.,
"increasing purity of the Escherichia coli phytase"

b.

Plaintiffs' supplemental proposed construction: Plain and ordinary meaning, e.g.
"removed from the growth medium with increased purity or concentration"

c.

ABF Defendants' original proposed construction: "removed from the growth
medium at a ratio of at least 80% pure"

d.

ABF Defendants' supplemental proposed construction: 3 "separated from any other
materials in the growth medium, including other proteins and cellular materials"

c.

Court's construction: "separated from any other materials in the growth medium,
including other proteins and cellular materials"

3

Defendants propose this construction without waiving previously raised indefiniteness arguments. (D.I. 65 at 2
n.3).

11

Plaintiffs argue that this term should be given its plain and ordinary meaning. (D.I. 62 at
72). Defendants assert that the term must be construed to have a quantitative limitation to avoid
indefiniteness. (Id. at 75-76). Plaintiffs oppose Defendants' construction because it improperly
imports limitations from a preferred embodiment into the claims. (Id. at 72).
I agree with Plaintiffs. The intrinsic evidence does not support importing a purity limitation
from a preferred embodiment into the claim language. The specification states, "The protein or
polypeptide of the present invention is preferably produced in purified form (preferably at least
about 80%, more preferably 90%, pure) by conventional techniques." ('150 patent, col. 7:17..,20
(emphasis added)).

It is improper to import limitations into the claims from a preferred

embodiment. Phillips, 415 F.3d at 1323. Defendants argue that Plaintiffs' construction will cause
the claim term to be indefinite. (D.I. 62 at 75-76). I disagree. "[B]readth is not indefiniteness."
BASF Corp. v. Johnson Matthey Inc., 875 F.3d 1360, 1367 (Fed Cir. 2017).

However, Plaintiffs' original proposed construction is not a helpful construction to
understand the term. Thus, at oral argument, I asked the parties to submit supplemental claim
construction briefing. (Hr'g Tr. at 121 :8-21). Plaintiffs continue to propose a construction of plain
and ordinary meaning but have altered their expression of that meaning to "removed from the
growth medium with increased purity or concentration." (D.I. 65 at 1). Defendants have proposed
an alternative construction which they argue comports with statements that Plaintiffs made in the
claim construction briefing. (Id.). In the original claim construction briefing, Plaintiffs argued
that "a person of ordinary skill would understand [this term] to mean the act of separating the
desired protein from any unwanted materials in the growth medium, including other proteins and
cellular materials." (D.I. 62 at 72). Defendants have essentially adopted this statement to be their
construction of this term.

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I agree with Defendants' supplemental construction. The specification repeatedly uses the
term "purify" in a context that indicates the intention is to remove the phytase protein from other
proteins and cells. See '300 patent, col. 16:20-23 ("Because phytase protein was secreted into the
medium in such a high level, it should be easy to purify .... "); col. 18:14-16 ("Most importantly,
enzyme proteins produced by S. cerevisiae are easily purified, because it secretes only a few
proteins."); col. 28:56-59 ("Because the expressed protein represented almost the only visible band
in the supernatant, it would be convenient to collect the enzyme product without the need for a
tedious purification."). Thus, the specification's use of the term "purify" repeatedly indicates that
the goal of the invention is to collect phytase protein on its own, rather than in combination with
the yeast cells or the growth medium.
Therefore, I construe the term "purified from the growth medium" to mean "separated from
any other materials in the growth medium, including other proteins and cellular materials."

5.

"isolating the expressed protein or polypeptide" ('150 patent, els. 1, 28; '063 patent,
cl. 1, '232 patent, cl. 1)
a.

Plaintiffs' proposed construction: Plain and ordinary meaning, e.g., "separating the
expressed protein or polypeptide from a host or host cells"

b.

DuPont Defendants' proposed construction: "Separating the expressed protein or
polypeptide from host cells, cell debris and other proteins such that the expressed
protein or polypeptide is at least 80% pure"

c.

Court's construction: Plain and ordinary meaning, e.g., "separating the expressed
protein or polypeptide from a host or host cells"

Plaintiffs argue that the Court should construe the term "isolating the expressed protein or
polypeptide" to have its plain and ordinary meaning, "separating the expressed protein or
polypeptide from a host or host cells." (C.A. 18-914, D.I. 65 at 70). The DuPont Defendants agree
that this term captures the concept of separating the expressed protein or polypeptide but argue

13

that the specification supports both the addition that the protein must be separated from cell debris
and other proteins as well as a numerical purity limitation. (Id. at 72-73).
First, the intrinsic evidence does not support importing a purity limitation from a preferred
embodiment into the claim language. The specification states, "The protein or polypeptide of the
present invention is preferably produced in purified form (preferably at least about 80%, more

preferably 90%, pure) by conventional techniques." ('150 patent, col. 7:17-20 (emphasis added)).
It is improper to import limitations into the claims from a preferred embodiment. Phillips, 415
F.3d at 1323. The Du.Pont Defendants argue that Plaintiffs' construction will cause the claim term
to be indefinite. (C.A. 18-914, D.I. 65 at 73-74). I disagree. "[B]readth is not indefiniteness."

BASF Corp., 875 F.3d at 1367. Moreover, a person of ordinary skill in the art would be able to
understand what the claim term requires without the numerical limitation. It requires separating
the expressed protein or polypeptide from a host or host cells. This is a binary proposition; either
the POSA engages in a separation step or they do not.
Second, the intrinsic evidence does not support requiring the protein or polypeptide to be
separated from more than the host or host cells.

The specification provides two identified

alternatives for obtaining the protein or polypeptide. First, "the protein or polypeptide ... is
secreted into the growth medium ofrecombinant host cells." (' 150 patent, col. 7:21-23). Second,
"[a]lternatively, the protein or polypeptide ... is produced but not secreted into growth medium.

In such cases, to isolate the protein, the host cell carrying a recombinant plasmid is propagated,
lysed by sonication, heat, or chemical treatment, and the homogenate is centrifuged to remove cell
debris."

(Id. at col. 7:23-28).

The term "isolating the expressed protein or polypeptide"

encompasses both alternatives. (Id. at cl. 1, 6, 7, 28, 31). Therefore, to import the limitations from
the second alternative method would improperly read in limitations from a single embodiment.

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Therefore, I construe the term "isolating the expressed protein or polypeptide" to have its
plain and ordinary meaning, "separating the expressed protein or polypeptide from a host or host
cells."
IV.

CONCLUSION

Within five days the parties shall submit a proposed order consistent with this
Memorandum Opinion suitable for submission to the jury.

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