Latex Allergen Reduction, LLC v. Dynarex Corporation

Filing 68

MEMORANDUM Opinion and Order Signed by the Honorable Elaine E. Bucklo on 4/21/2011:Mailed notice(mpj, )

IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION

LATEX ALLERGEN REDUCTION, LLC,
Plaintiff/Counter-Defendant,
v.
DYNAREX CORPORATION,
Defendant/Counter-Plaintiff.

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No. 10 C 129

MEMORANDUM OPINION AND ORDER
Plaintiff Latex Allergen Reduction, LLC (“LAR”) has brought
this suit against defendant Dynarex Corporation (“Dynarex”) for
patent infringement of LAR’s U.S. Patent 5,777,004 (the “‘004
Patent”).

The ‘004 Patent is directed to a method of neutralizing

protein allergens found in natural rubber latex. ‘004 Patent, Col.
2, lines 24-25.

The proteins in natural rubber latex that cause

allergic reactions are made of chemical chains called “peptides,”
which are themselves chemical chains of amino acids.

The patented

invention relies on a protease enzyme and a peptidase enzyme to
break down or degrade the protein allergens in the natural rubber
latex so that the remaining particles are “too small to elicit an
allergic reaction in humans.”

Id. at Col. 4, lines 1-3.

The

preferred method of the ‘004 Patent involves a two-step process for
treating natural rubber latex.
line 46.

Id. at Col. 5, line 29 - Col. 6,

In the first treatment step, a protease enzyme solution

is applied to the latex.

In a second step, a peptidase enzyme

solution is introduced to continue the process of breaking down the
proteins.

Id. at Col. 6, lines 12-13.

The patent explains that

“[w]hen the protease treatment and the peptidase treatment yield
the preferred [degree of chemical break down] the allergenicity of
the latex is reduced below detectable levels.”
lines 41-46.

Id. at Col. 6,

The ‘004 Patent also states that the solutions of

protease and peptidase enzymes can be simultaneously added in a
single step.

Id. at Col. 6, lines 49-54.

Because the parties disagree as to the meaning of certain
terms and phrases used in the ‘004 Patent, this opinion construes
those

terms

and

phrases

pursuant

to

Markman

v.

Westview

Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995).
I.
“[T]he interpretation and construction of patent claims, which
define the scope of the patentee’s rights under the patent, is a
matter of law exclusively for the court.”
71.

Markman, 52 F.3d at 970-

Claim terms “are generally given their ordinary and customary

meaning,” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582
(Fed. Cir. 1996), which is to say the meaning those words would
have to a person of ordinary skill in the art at the time of the
patent’s effective filing date.
1303, 1313 (Fed. Cir. 2005).

Phillips v. AWH Corp., 415 F.3d

The so-called “intrinsic evidence,”

i.e., the claim language itself, the patent’s specification, and

2

its prosecution history, is of paramount significance in construing
disputed terms. While “extrinsic evidence,” i.e., everything else,
may be helpful to understand the meaning of technical or scientific
terms, such evidence is considerably less reliable than intrinsic
evidence for determining “the legally operative meaning of claim
language,” id. at 1317.
Analysis of the intrinsic evidence always begins with the
language of the claims.

Vitronics, 90 F.3d at 1582.

Next comes

the patent specification, which “‘is always highly relevant to the
claim construction analysis.’” Phillips, 415 F.3d at 1314 (quoting
Vitronics, 90 F.3d at 1582).

Nevertheless, “limitations from the

specification are not to be read into the claims.”

Golight, Inc.

v. Wal-Mart Stores, Inc., 355 F.3d 1327, 1331 (Fed. Cir. 2004)
(citations omitted).

While a patentee is free to be his or her own

lexicographer and ascribe a special definition to a given term,
“any special definition given to a word must be clearly defined in
the

specification.”

Markman,

52

F.3d

at

980.

Like

the

specification, the prosecution history is considered reliable
evidence

of

the

meaning

of

claim

terms,

but

it

too

“cannot

‘enlarge, diminish, or vary’” the limitations in the claims.

Id.

(quoting Goodyear Dental Vulcanite Co. v. Davis, 102 U.S. 222, 227
(1880)).
With these general principles in mind, I turn to the claim
terms in dispute.

3

II.
A. “non-allergenic to humans”
1.

All Protein Allergens vs. Two or More Protein Allergens

Claim 1 states:
A method of neutralizing protein allergens in natural
rubber latex comprising treating the natural rubber latex
with a protease enzyme and a peptidase enzyme such that
the protein allergens contained within the natural rubber
latex are degraded to polypeptide fragments and amino
acids which are non-allergenic to humans.
‘004 Patent, Col. 11, lines 40-45 (emphasis added).

LAR begins by

proposing that “non-allergenic to humans” means that only the
protein allergens that are actually degraded are incapable of
producing an allergic reaction in most humans.

To get to this

articulation, LAR first argues that I should look to the preamble1
of Claim 1 to understand the antecedent basis for the phrase “the
protein allergens.”

According to LAR, the use of the phrase

“protein allergens” in the preamble2 to Claim 1 means that the
invention requires only that two or more protein molecules be
“degraded,” and that the latex itself need not be made non or less
allergenic

so

long

as

two

or

more

protein

molecules

are

1

Both parties have agreed that the phrases used in the
preamble have no patentable weight.
2

The pertinent section in the preamble states: “Disclosed is
a method of treating natural rubber latex with protease and
peptidase enzymes, whereby protein allergens contained within the
latex are degraded so as to be rendered non-allergenic to humans.
The protein allergen-free natural rubber latex produced by the
method and articles fabricated from the protein allergen-free
product are also disclosed.” ‘004 Patent Preamble.
4

neutralized. LAR then uses this proposed understanding of “protein
allergens” in the preamble to argue that “the protein allergens
contained within the natural rubber latex” in Claim 1 is limited to
two or more protein molecules.

LAR goes on to explain that the

clause “which are non-allergenic to humans” is plural and must
modify “polypeptide fragments and amino acids” and not the singular
noun, “latex.” LAR suggests that “the prepositional phrase ‘within
the natural rubber latex’ simply mirrors the language of the
preamble and states where the protein allergens that are degraded
are located.”

LAR Resp. at 15.

LAR goes on to state that “the

clear meaning of claim 1 is that those protein allergens that are
degraded are degraded to polypeptide fragments and amino acids
which are non-allergenic to humans.”

Id. (emphasis in original).

According to Dynarex, the claim language clearly “identifies
which proteins need to be degraded: the protein allergens contained
within the natural rubber latex.”
does

not

say

“some

protein

Dynarex Mem. at 10.

allergens”

or

contain

The claim
any

other

qualifier. Further, LAR’s proposed construction should be rejected
because it would deprive the invention of utility and render the
claim invalid.

According to Dynarex, “[d]egrading a small or

limited quantity of the proteins contained with[in] the latex would
clearly have no substantive effect on the allergenicity of the
latex, and, thus, provide no utility.”

5

Id.

A preliminary issue I must address is whether Claim 1 requires
that all the protein allergens contained within the natural rubber
latex be degraded to a certain level (as advanced by Dynarex) or
whether only two or more protein molecules must be degraded (as
advanced by LAR).

I conclude that the plain language of Claim 1

indicates that all the protein allergens contained within the latex
must be degraded.

The language of claim 1 expressly describes

which protein allergens (“the” protein allergens contained within
the natural rubber latex) must be degraded.

Because I do not see

any ambiguity in this language, I reject LAR’s suggestion that I
look to the preamble as an antecedent basis for the phrase “the
protein allergens.”

See The United States Patent and Trademark

Office Manual of Patent Examining Procedure 2173.05(e)(explaining
that an antecedent basis is required in drafting a claim when the
term is so vague or general that it would otherwise be invalid for
indefiniteness); see also Pitney Bowes, Inc. v. Hewlett-Packard
Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999) (“If the body of a claim
fully

and

intrinsically

sets

forth

the

complete

invention,

including all of its limitations, and the preamble offers no
distinct definition of any of the claimed invention’s limitations,
but rather merely states, for example, the purpose or intended use
of the invention, then the preamble is of no significance to claim
construction[.]”).

6

The teachings of the specification support this conclusion.
Z4 Technologies, Inc. v. Microsoft Corp., 507 F.3d 1340, 1348 (Fed.
Cir. 2007) (fundamental rule of claim construction is that a claim
should

be

construed

specification).

consistent

The

with

specification

the

makes

teachings
clear

that

of

the

“[t]he

invention is a method for neutralizing protein allergens in natural
rubber latex, thereby rendering the latex and articles formed from
the latex non-allergenic to humans.”
8.

The

invention

achieves

its

‘004 Patent Col. 1, lines 6utility

by

applying

enzyme

treatments to the natural rubber latex “such that the protein
allergens contained therein are degraded.”
32-35.

Id. at Col. 2, lines

The patent also references “non-protein allergenic natural

rubber latex” and the “non-protein allergenicity of the latex.”
Id. at Col. 8, lines 1-15.

All of these references, in addition to

the plain language of the claim, support my conclusion.

Dynarex

maintains that LAR’s construction would make no sense in light of
the purpose of the invention, as under LAR’s construction the
claimed

method

need

only

degrade

some

undefined

quantity

of

allergenic proteins contained in the natural rubber latex to a nonallergenic
substantial

level,

even

quantities

if
of

the

latex

non-degraded

allergenic to humans. I agree.

7

continues

to

contain

proteins

that

remain

2.
In

“Non-Allergenic to Humans”
its

response,

LAR’s

proposed

construction

of

“non-

allergenic to humans” presupposes that I have agreed with its
suggestion to limit Claim 1 to only those protein allergens that
are actually degraded.

Because I have rejected that argument, it

is difficult to figure out exactly what LAR intends to argue with
respect to the phrase “non-allergenic to humans.”

It is clear,

however, that LAR argues that “non-allergenic” cannot mean that the
invention completely eliminates the allergenicity of latex for all
humans.

According to LAR, that would be impossible.

Instead, LAR

proposes that it means some level of reduced allergenicity, and, in
support, it points to portions of the specifications explaining
that the protein allergens were “greatly reduced” or became “far
less allergenic.” LAR Resp. at 11-12. However, LAR never expressly
asks the court to construe “non-allergenic” as “greatly reduced”
allergenicity. In addition, LAR argues that the phrase “to humans”
should be defined to mean “most humans.”

LAR asserts a person of

ordinary skill in the art would understand the phrase “to humans”
to mean “to most humans.”
Dynarex stresses the “heavy presumption” courts must apply in
favor of the ordinary meaning of a claim term, “unless the patentee
unequivocally imparted a novel meaning” to the term.

Omega Eng’g,

Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003).
Dynarex proposes that the claim term “non-allergenic to humans” be

8

given its plain and ordinary meaning that “the protein allergens
contained within the natural rubber latex are degraded such that
the natural rubber latex is incapable of producing an allergic
reaction in any human.”

Dynarex Br. at 8.

In its reply, it

suggests that the following might be added to the end of that
suggested phrasing: “as demonstrated by having non-detectable
levels of protein allergens.”

Dynarex Rep. at 12.

Dynarex points

out that the specification makes clear that the invention is
directed towards the problem of protein allergens in natural rubber
latex causing an allergic reaction in humans.

The specification

further states that the method of the invention treats the latex
with protease and peptidase enzymes in order “to degrade proteins
found within the rubber latex to a molecular weight which renders
the protein too small to elicit an allergic reaction in humans.”
‘004 Patent, Col. 4, lines 1-3.
total

elimination

of

all

Dynarex counters LAR’s claim that

protein

allergens

is

impossible

by

asserting:
Dynarex never argues that every last molecule of protein
allergen needs to be eliminated. Dynarex simply contends
that the protein allergens contained within the latex
have to be degraded sufficiently such that the latex does
not cause an allergic reaction in humans – just what the
claim language says.
Dynarex Rep. at 8.

Finally, Dynarex argues that construing “non-

allergenic” to mean “greatly reduced” allergenicity and construing
“to humans” to mean “to most humans” would be too indefinite, and
would not “particularly point out and distinctly claim the subject
9

matter the patent applicant considers to be the invention.”
Dynarex Rep. at 9.
I start with the plain language of the phrase, “non-allergenic
to humans.”

The phrase, as stated, clearly means that the treated

latex does not produce an allergic reaction in any humans. It does
not mean, however, that the treated latex is completely devoid of
protein allergens, just that those allergens remaining are “too
small to elicit an allergic reaction in humans.” ‘004 Patent, Col.
4, lines 1-3.

In an attempt to deviate from this plain meaning,

LAR points to sections of the specification which describe the
protein allergens as “greatly reduced” or “far less allergenic”
than those found in untreated latex.

Dynarex argues that these

types of terms are far too vague and indefinite to provide an
adequate construction of the term “non-allergenic.”
I conclude that the term “non-allergenic to humans” means that
“the protein allergens contained within the natural rubber latex
are degraded such that the natural rubber latex is incapable of
producing an allergic reaction in any human as demonstrated by
having non-detectable levels of protein allergens.”
points

to

conclusion.

examples

in

the

specification

which

Even LAR

support

this

See ‘004 Patent, Col. 6, lines 40-45 (“When the

protease treatment and the peptidase treatment yield the preferred
[degree of chemical break down] the allergenicity of the latex is
reduced below detectable levels”)(emphasis added); Col. 9, lines

10

44-46 (noting that the allergen content of the “Treated” sample was
below the detection limit of the test). This conclusion is further
supported by other parts of the specification, wherein the treated
latex is described as “effectively protein non-allergenic” and
“extremely protein allergen-free.”
66; Col. 2, lines 57-60.
LAR

has

failed

to

‘004 Patent, Col. 7, lines 65-

With respect to the phrase “to humans,”

point

to

language

in

the

claim,

the

specification, or the prosecution history which would convince me
that the phrase should be given something other than its plain
meaning.
Nor am I convinced that LAR’s position is supported by the two
cases cited by LAR.

In Microthin.com, Inc. v. Siliconezone USA,

LLC, 377 Fed. Appx. 8 (Fed. Cir. 2010), the court gave “non-slip”
its ordinary meaning of “reduces or prevents smooth sliding action”
and held that the patent at issue in that case did not distinguish
between sticky and non-sticky characteristics.

The real issue

before the court was whether the product had “to reduce or prevent
smooth

sliding

motion

without

being

sticky

to

the

Microthin.com, 377 Fed. Appx. at 11 (emphasis added).

touch.”
Therefore,

the parties were not fighting over, and the court did not address,
whether “non-slip” means the reduction or prevention of smooth
sliding action (which would be more akin to the issue in this
case), but rather whether or not the claim could be read to address
whether the absence of stickiness was also required.

11

In light of

this, I do not find this case to be helpful in deciding the issue
currently before me.
LAR’s second case, Koninklijke Philips Electronics N.V. v.
Cinram Int’l, Inc., et al., 709 F. Supp. 2d 259 (S.D.N.Y. 2010),
supports

my

construction

of

“non-allergenic

to

humans.”

In

Koninklijke, the patent in suit involved a “non-transmissive”
optical structure.

709 F. Supp. 2d at 262. The defendants urged

the court to conclude that “non-transmissive” meant that the
optical structure “does not transmit radiation such as light,”
while the plaintiff argued that the term should be understood as
characterizing the method by which a disk is read.
court

reviewed

both

intrinsic

and

ultimately side with defendants.

extrinsic

The district

evidence,

to

The court credited defendants’

expert who averred that,
[O]ne of ordinary skill in the art in 1972 would have
read the ‘846 Patent and the prosecution history to
unequivocally state that the optical structure does not
transmit light.
Schlesinger Decl. ¶ 6.
More
specifically, Dr. Schlesinger testified that the
hypothetical person skilled in the art in 1972 would have
understood that the optical structure should be made “as
non-transmissive as possible and practical and that while
theoretically and even actually some photons may pass
this is irrelevant as they are not seen or detected on
the other side of the structure.
Id. at 267.

Based on all the evidence, the court construed the

term “non-transmissive” to mean “an optical structure that reduces
the

transmission

of

radiant

light

to

the

greatest

practicable consistent with the intended purpose.”

12

degree

Id. at 268.

The construction I have reached with respect to “non-allergic
to humans” is consistent with Koninklijke, in that I have construed
“non-allergenic” in light of the intended purpose of the invention
to conclude that “the protein allergens contained within the
natural rubber latex are degraded such that the natural rubber
latex is incapable of producing an allergic reaction in any human
as

demonstrated

allergens.”

by

having

non-detectable

levels

of

protein

The optical structure in Koninklijke was deemed “non-

transmissive” even if a non-detectable level of photons actually
passed through it.

Likewise here, I have concluded that “non-

allergic to humans” allows for some of the protein allergens to
remain, so long as they are below detectable levels.
B.

“A Protease Enzyme and a Peptidase Enzyme”
Claim 1 claims a method of “treating the natural rubber latex

with a protease enzyme and a peptidase enzyme.”

Dynarex argues

that this plainly refers to treating natural rubber latex with two
distinct enzymes: a “protease” enzyme and a “peptidase enzyme.”
Specifically, Dynarex asks me to construe this phrase as “both
separate and distinct enzymes, wherein one enzyme is a protease
enzyme and the other enzyme is a peptidase enzyme, and that the two
enzymes are not the same.”
In

contrast,

LAR

asserts

that

Dynarex

seeks

to

impose

limitations on this phrase that do not appear in the claim.

LAR

proposes that the phrase “a protease enzyme and a peptidase enzyme”

13

be construed to mean “both two separate and distinct enzymes,
wherein one enzyme is a protease enzyme and the other enzyme is a
peptidase enzyme, as well as a single enzyme having both protease
activity and peptidase activity.”

LAR Resp. at 19.

According to

LAR, “a protease enzyme and a peptidase enzyme” does not exclude
the possibility that the protease and peptidase enzyme are the
same, single enzyme having both protease and peptidase activity.
Both

parties

agree

that

the

patent

includes

numerous

references to treating the natural rubber latex with proteases and
peptidases.

See, e.g., ‘004 Patent Abstract (“Disclosed is a

method of treating natural rubber latex with protease and peptidase
enzymes.”); id. at Col. 2, lines 25-29 (“The method includes the
step of treating natural rubber latex with at least one enzyme
having protease activity and at least one enzyme having peptidase
activity.”);

id.

at

Col.

2,

lines

40-45

(“Then,

in

a

first

treatment step, treating the natural rubber latex with a protease
enzyme in a vapor-tight vessel . . . . Then, in a second treatment
step, treating the natural rubber latex with a peptidase enzyme in
a vapor-tight vessel.”); id. at Col. 4, lines 53-56 (“In short, any
combination of one or more enzymes having protease activity and one
or more enzymes having peptidase activity which, in combination or
in sequence, will successfully cleave the proteins. . . .”); id. at
Col. 6, lines 48-50 (“The present invention also includes a one

14

step hydrolysis wherein solutions of proteases and peptidases are
simultaneously added[.]”).
LAR argues, however, that the patent’s description of a single
step where a protease enzyme and a peptidase enzyme are added
simultaneously encompasses a single enzyme with both protease and
peptidase

properties.

LAR

points

to

two

sections

of

the

specification to support its argument that “a protease and a
peptidase enzyme” could also include one enzyme with both protease
and peptidase properties.

The portion of the specification LAR

relies on provides,
The method functions successfully using any now known or
henceforth discovered enzyme having protease and/or
peptidase activity.
Such proteases and peptidases
include, but are not limited to, enzymes isolated from
animal, microbial, and plant sources. From a present
cost perspective, enzymes derived from microbial sources
are most economical due to their wide commercial
availability. However, the preferred enzymes for use in
the invention are enzymes having protease and/or
peptidase activity which are isolated from mammalian
sources or which are manufactured via recombinant
genetics (or wholly synthetic methods) using mammalian
gene-coding sequences.
‘004 Patent, Col. 4, lines 4-15 (emphasis added).

LAR points to

the use of “and/or” in the above passage to argue that the
specification

contemplates

one

enzyme

with

both

protease

tends

to

support

part

above,

and

peptidase activities.
The

intrinsic

construction.
contains

over

As
20

evidence
detailed

mentions

in
of

protease
15

the

enzymes

Dynarex’s

specification
and

peptidase

enzymes, and discusses them as separate enzymes.

Moreover, the

specification, in discussing the single-step option (wherein the
protease

and

the

peptidase

enzymes

are

added

to

the

latex

simultaneously), states that the “protease and peptidase treatments
may

be

combined

selected.3

into

a

single

step

if

suitable

enzymes

are

‘004 Patent, Col. 4, lines 66-67 - Col. 5, line 1

(emphasis added).

The use of the plural “enzymes” supports a

construction that the protease and the peptidase enzymes are
separate and distinct enzymes.

Likewise, the following statement

in the specification also supports Dynarex’s position that even in
the one-step treatment two distinct enzymes are required:

“The

present invention also includes a one step hydrolysis wherein
solutions of proteases and peptidases are simultaneously added to
the natural rubber latex.”
added).

Id., at Col. 6, lines 49-51 (emphasis

Finally, the specification states that, “[i]n short, any

combination of one or more enzymes having protease activity and one
or more enzymes having peptidase activity . . . may be utilized in
the present method.”

Id. at Col. 4, lines 53-55 (emphasis added).

As Dynarex points out, “[i]f the limitation ‘a protease enzyme and
a

peptidase

enzyme’

were

interpreted

3

to

encompass

a

method

I reject LAR’s contention that Dynarex’s construction
excludes a preferred embodiment. Dynarex does not dispute that the
‘004 Patent, in addition to a two-step treatment, contemplates a
one-step treatment during which the protease and peptidase enzymes
are simultaneously added. The question is whether or not that onestep treatment can be achieved with a single enzyme.
16

involving only one enzyme, there would be no ‘combination’ of
anything.”

Dynarex Mem. at 13.

Because this issue of two enzymes versus one enzyme is not as
clear cut as the “non-allergenic to humans” construction, I will
also consider the expert testimony I heard at the evidentiary
hearing in this matter.

See, e.g., Phillips, 415 F.3d at 1317-19

(stating that a district court may, in its discretion, consider
expert testimony to determine how one of ordinary skill in the art
would understand the patent).

Each side presented expert opinion

in an attempt to support their proposed constructions. As detailed
below, I credit the testimony of Dynarex’s expert over that of
LAR’s, and conclude that the extrinsic evidence support Dynarex’s
construction.
Dynarex’s expert, Dr. Louis DeFilippi4, testified that a
person of ordinary skill in the art would understand the ‘004
Patent to require the use of two separate enzymes:
enzyme and a peptidase enzyme.

a protease

He testified that an enzyme is “a

4

Dr. DeFilippi received a B.A. in chemistry with honors from
Queens College in the City University of New York and received his
Ph.D. in biological chemistry from the University of Michigan in
Ann Arbor, Michigan. He did post doctorate work at the University
of Michigan and Cornell University in Ithaca, New York. All of his
academic study and research involved enzymes. His professional
experience, which included working at UOP Research Center, Allied
Signal Research and his own consulting practice, also involved
enzymes. He testified that 50 to 75 percent of his 40+ years of
experience has been dedicated to research and application of
enzymes in industry. Dr. DeFilippi testified that he, as a person
who had a degree in biochemistry and has studied enzymology, is a
person of ordinary skill in the art. 4/11/11 Tr. at 17-18.
17

biological molecule that’s a catalyst.

It speeds up a reaction.

Enzymes are very, very precisely defined and have very, very
precise activities.” 4/11/11 Tr. at 12. He further explained that
the enzymes used in the ‘004 Patent are those which break down
proteins.

Id. at 13.

By way of background, Dr. DeFilippi described in detail the
differences between protease enzymes and peptidase enzymes.

He

stated that every protein is made up of amino acids, and those
amino acids are always found in the exact same sequence for a
particular protein. These individual amino acids are held together
by bonds called amide linkages. Turning first to protease enzymes,
Dr. DeFilippi explained that a protease enzyme has “endo activity,”
which means that it cleaves the bond between two very specific
amino acids, and does not cleave the bond between any of the other
amino acids.

This process of cleaving bonds results in smaller

chains of amino acids, called peptides.

In contrast, a peptidase

enzyme, with “exo activity,” starts at one end or the other of a
peptide, and cleaves off one amino acid at a time from the end of
the peptide.

A peptidase will continue to cleave off one amino

acid, from the end of the peptide, until only mono and dipeptides
are remaining (or until it hits a particular kind of amino acid
which can act as a blocker).
Dr. DeFilippi explained that, due to the distinct functions of
each type of enzyme, a protease enzyme cannot do what a peptidase

18

enzyme does.
acid

(or

a

A protease enzyme looks for a very specific amino
few

amino

acids)

within

in

the

protein

chain.5

According to Dr. DeFilippi, enzymes, which are “highly specific,”
“will perform certain catalytic actions and no other.” 4/11/11 Tr.
at 27.

In light of this, Dr. DeFilippi testified that a person of

ordinary skill in the art would understand the ‘004 Patent to “need
two distinct and different enzymes, one is the protease and the
second is the peptidase, where the protease is the one that has the
endo activity and creates a family of peptides, and then the
peptidase by its name you can tell already is the enzyme that
attacks the peptides and breaks them down to smaller units, amino
acids and then some smaller peptides.”

Id. at 28.6

5

Dr. DeFilippi explained that you might fortuitously have
one of the target amino acids at the end of the chain, and the
protease might therefore cleave off an amino acid at the end of the
chain, “but that’s the exception, not the rule.” 4/11/11 Tr. at
23.
6

On cross examination, Dr. DeFilippi acknowledged that one
could purchase a bottle of enzymes, either a “preparation” or an
impure batch of enzymes, which could have both protease and
peptidase activities. However, in both the case of a preparation
and the case of an impure batch of enzymes, any potential
combination of protease and peptidase activities would be the
result of a mixture of different enzymes, and not the result of one
enzyme.
19

Conversely, LAR’s expert, Dr. Katrina Cornish7, testified that
one enzyme could have both protease and peptidase properties.

Dr.

Cornish explained that the term, “enzyme,” can either be a very
precise term or it can be used “much more imprecisely.” 4/1/11 Tr.
at 53.

As an example, Dr. Cornish explained that it is very

difficult to purify an enzyme, such that only one homogeneous
enzyme is present.

She went on to state that if she were to

purchase a bottle of a commercially-available enzyme, that bottle
could contain both protease and peptidase activities.

Because the

source for the product comes from a biological system, “you would
tend to get some of the other things that are in that biological
system as well, and unless you purify it extremely rigorously, you

7

Dr. Cornish received a first class honors in biological
sciences with a minor in biochemistry from the University of
Birmingham, England.
She received her Ph.D. from the same
institution in plant biology, and has several post doctorate awards
working for the United States Department of Agriculture (“USDA”).
Since completing her academic studies, she has been employed by
Yulex Corporation, the USDA, and Arizona State University. She is
currently employed by the Ohio State University, as an Ohio
Research Scholar and Endowed Chair in bioemergent materials
specializing in biowaste materials with bio-based fillers and
fibers, and also bio-based versions of synthetic polymers. Her
work has focused on the guayule, which is a source of
hypoallergenic latex which comes from a desert shrub. She has won
numerous awards, published articles on latex, and holds at least
four patents related to latex in the United States, and about 53
patents related to latex issued in other countries. Since 1987,
Dr. Cornish’s work has involved latex. Since 1990-1991, her work
has also included studying the allergenicity of latex. According
to Dr. Cornish, a person of ordinary skill in the art would be a
scientist, an immunochemist, a biochemist, a product development
person or an immunologist. Dr. Cornish testified that she is such
a person.
20

know, really ad infinitum, you will get some contamination from the
original system.”

Id. at 55.

Again, by way of example, Dr.

Cornish testified that if she were to purchase a bottle labeled as
a “protease,” assuming it was relatively inexpensive, “I would
expect it to primarily be the one that the name said and that there
would be a bunch of other things in it that probably aren’t even
listed.”

Id.

Taking a somewhat different tack, Dr. Cornish also testified
that one’s characterization of a particular enzyme is “really a
matter of definition.”

4/11/11 Tr. at 57.

are exopeptidases and endopeptidases.

She stated that there

An exopeptidase can cleave

the first or second bond in a peptide. An endopeptidase can cleave
in the middle of the peptide.

She explained that the difference

between a protease (which cleaves in the middle of a peptide) and
an endopeptidase (which also cleaves in the middle of a peptide)
“is a matter of degree, semantics.”

Id.

An enzyme could be called

a protease when it first starts to chop a large protein into large
peptides, and it might be considered an endopeptidase as the
peptides chains get smaller.

She testified that she, as a person

of ordinary skill in the art, would practice the invention of the
‘004 Patent by “buy[ing] one bottle of one broad specificity
protease, as broad specificity as I could find, and see if that one
would do all of that without having to pay for another one.”

Id.

at 69, 70 (“Q. So your testimony is reading this patent and the

21

claim language that says it’s a treatment involving a protease and
a peptidase, that what you would do is you would just go out and
buy a protease?

A. Exactly that is what I would do.”).

She

explained that if one were to use a broad specificity protease,
which cleaves bonds in multiple locations, “you may well end up in
effect with exactly where you would be if you added one that was a
specific peptidase to get down to those tiny, tiny fragments.

But

if I had this broad peptidase and found a lot of stuff, say 10,000
molecular

weight

protein

–

peptidase

as

well,

I’d

go

throw

peptidase in there and chop those peptides into much smaller ones
again.”

Id. at 73-74.

I reject Dr. Cornish’s testimony, and rely instead on Dr.
DeFilippi’s conclusion that the ‘004 Patent refers to two distinct
enzymes, for a number of reasons. First, Dr. Cornish’s theory that
the patent contemplates that a person attempting to practice the
patent would use an inexpensive, impure bottle of protease enzymes
which might (or might not) contain separate peptidase enzymes has
no

support

inexpensive,

in

the

impure

patent.
bottle

As
of

both

protease

experts

testified,

enzymes

would

an

contain

proteases (i.e., what the labels says it contains), but would also
contain any number of other enzymes.

Therefore, in this scenario,

such a bottle may or may not contain peptidases.

There is nothing

in the patent or specifications which contemplates testing a bottle
of impure proteases to determine if that bottle has sufficient

22

peptidases

to

perform

the

necessary

peptidase

activity.

Ultimately, this theory is unsupported by the ‘004 Patent.
I likewise reject Dr. Cornish’s second theory, which is that
one skilled in the art would simply buy a broad specificity
protease, add it to the natural rubber latex and hope that it,
acting alone, would sufficiently break down the protein allergens
small enough to fall below detectable levels (and would only add in
a specific peptidase enzyme if the degradation was insufficient).
This is clearly not what the ‘004 Patent contemplates.

See

Phillips, 415 F.3d at 1318 (“[A] court should discount any expert
testimony that is clearly at odds with the claim construction
mandated by . . . the written record of the patent.”).

The patent

says nothing about using a broad specificity protease, checking the
peptides to determine whether the peptides have been sufficiently
broken down, and then, if not, adding in a peptidase enzyme to
finish off the process.

Therefore, Dr. Cornish’s theory that a

protease enzyme could do the job itself is incompatible with the
‘004 Patent.
In

light

of

the

language

of

the

‘004

Patent,

the

specifications and the compelling testimony of Dr. DeFilippi, I
conclude that “a protease enzyme and a peptidase enzyme” means
“both separate and distinct enzymes, wherein one enzyme is a
protease enzyme and the other enzyme is a peptidase enzyme, and
that the two enzymes are not the same.”

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ENTER ORDER:

____________________________
Elaine E. Bucklo
United States District Judge
Dated: April 21, 2011

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