Ward v. Walgreen Company et al

Filing 132

MEMORANDUM Opinion and Order Signed by the Honorable John Z. Lee on 6/17/15Mailed notice(ca, ).

IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
PROFOOT INC.,
Plaintiff,
v.
MERCK & CO., INC.
Defendant

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11 C 9004
Judge John Z. Lee

MEMORANDUM OPINION AND ORDER
Plaintiff Eric Ward (“Ward”) has sued Defendant Merck, Inc. (“Merck”) alleging
infringement of U.S. Patent No. 6,845,568 (the “’568 Patent”).

The allegedly infringing

activities concern Dr. Scholl’s Custom Fit Orthotic Centers and Custom Fit Orthotic Inserts,
which are manufactured, marketed, and sold by Merck. 3d Am. Compl. ¶¶ 50, 51, 54; Def.’s
Resp. 3d Am. Compl. ¶ 12.

Merck has placed Dr. Scholl’s Custom Fit Orthotic Centers

throughout the United States in various retail stores, including Walgreens and Sears. Def.’s Resp.
3d Am. Compl. ¶ 15. The original complaint named only Walgreen Company (“Walgreens”)
and Sears Holdings Corporation (“Sears”) as defendants. Compl. ¶¶ 5-6. But Ward later
amended the complaint to include Merck and then voluntarily dismissed the suits against
Walgreens and Sears. 1st Am. Compl. ¶ 5; dkt. 28, 29. Subsequently, ProFoot, Inc. (“ProFoot”)
purchased the patent-in-suit from Ward, including the right to sue for past, present, and future
infringement. 3d Am. Compl. ¶ 2. The parties now ask the Court to construe six terms that
appear in the ’568 Patent.

I.

Background
The patent-in-suit relates to a method for measuring and correcting the pronation of a

person’s foot. See ’568 Patent col.1 ll.17-18, Joint Appendix (“J.A.”) 93. The method utilizes a
device called a “neutralizer” in the following manner. First, an individual places one foot on the
device while keeping another foot off of it. Id. at col.5 ll.11-13, col.6 ll.3-5, J.A. 95. Then, the
“neutralizer” is used to determine “the angle necessary to place the [right or left] ankle in a
neutral position.” Id. at col.5 ll.14-15, col.6 ll.6-7, J.A. 95. Finally, an individual is provided
with “an insert having an angle which represents the neutral state for the [right or left] ankle.” Id.
at col.6 ll.1-2, 8-9, J.A. 95.

This method enables the individual to correct any pronation by

obtaining a foot insert that may be used in “ski boots, skates, bike shoes and the like.” Id. at
col.1 ll.9-12, J.A. 93.
On September 22, 2000, Ward filed U.S. App. No. 09/667,998, the parent application of
the patent-in-suit.

It disclosed a system and a method for measuring foot pronation and

correcting it by using a foot insert. U.S. App. No. 09/667,998, J.A. 27. On May 20, 2003, the
application issued as U.S. Pat. No. 6,564,465 (the “’465 Patent”) with a claim that covered only a
system for creating a foot insert. ’465 Patent, J.A. 11. This patent is not asserted in the present
case.
On March 14, 2003, Eric Ward filed U.S. App. No. 10/389,435 as a continuation-in-part
of U.S. App. No. 09/667,998. U.S. App. No. 10/389,435, J.A. 96. This second application
claimed only a method of fitting an individual with the foot inserts. Id. at 113-14. It issued as
the ’568 Patent—the patent asserted in this case.
To furnish foot inserts to its customers, Merck developed special kiosks, called Dr.
Scholl’s Custom Fit Orthotic Centers. Def.’s Resp. 3d Am. Compl. ¶ 13. These kiosks, located

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in various retail stores in the United States including Walgreens and Sears, contain a pressuremeasuring device. Id. ¶¶ 15, 19. This device allows customers to analyze their feet, so that they
can use these measurements to choose one of the off-the-shelf Dr. Scholl’s Custom Fit Orthotic
Inserts. Id. ¶¶ 19, 22.
The following terms of the ’568 Patent are in dispute: (1) neutralizer; (2) neutral position;
(3) using the neutralizer to determine the angle necessary to place the <right or left> ankle in a
neutral position; (4) providing an insert having an angle which represents the neutral state for the
<right or left> ankle; (5) creating a <right or left> foot insert; and (6) predetermined inserts.
II.

Legal Standard
Claim construction is a question of law to be decided by a judge. Markman v. Westview

Instruments, Inc., 517 U.S. 370, 391 (1996). Words “are generally given their ordinary and
customary meaning.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
“[T]he ordinary and customary meaning of a claim term is the meaning that the term would have
to a person of ordinary skill in the art in question at the time of the invention.” Phillips v. AWH
Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005). A person of ordinary skill in the art is assumed to
read the claim term in the context of the entire patent. Id.
The Court’s analysis begins with the intrinsic evidence, which consists of the patent itself
(including claims, specification, and Abstract) and the prosecution history. Vitronics, 90 F.3d at
1582 (“in interpreting an asserted claim, the court should look first to the intrinsic evidence of
record, i.e., the patent itself, including the claims, the specification and, if in evidence, the
prosecution history”); Hill–Rom Co. v. Kinetic Concepts, Inc., 209 F.3d 1337, 1341 n.1 (Fed. Cir.
2000) (courts “have frequently looked to the abstract to determine the scope of the invention”).
The specification is usually “dispositive; it is the single best guide to the meaning of a disputed

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term.” Vitronics, 90 F.3d at 1582. Claim terms are given “the meaning and scope with which
they are used in the specification and the prosecution history.” Kinik Co. v. ITC, 362 F.3d 1359,
1365 (Fed. Cir. 2004). But a particular embodiment described in the specification should not be
read into the claim when claim language is broader than the embodiment. Superglide Corp. v.
DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). That said, a claim may be limited to
its preferred embodiment if permitting expansive claim language would undermine the public
notice requirements of 35 U.S.C. § 112. LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d
1336, 1346 (Fed. Cir. 2005).
Furthermore, the context in which a term appears in a claim is also instructive. Phillips,
415 F.3d at 1314. Likewise, other claims are “valuable sources of enlightenment as to the
meaning of a claim term.” Id. Under the doctrine of claim differentiation, “each claim in a
patent is presumptively different in scope.” RF Del., Inc. v. Pac. Keystone Techs., Inc., 326 F.3d
1255, 1263 (Fed. Cir. 2003). “That presumption is especially strong when the limitation in
dispute is the only meaningful difference between an independent and dependent claim.”
Acumed LLC v. Stryker Corp., 483 F.3d 800, 806 (Fed. Cir. 2007). Claim differentiation,
however, is a “rule of thumb” and not absolute — it does not trump “the clear import of the
specification” or the disclaimer of the subject matter in the prosecution history. See Edwards
Lifesciences LLC v. Cook, Inc., 582 F.3d 1322, 1332 (Fed. Cir. 2009); Fantasy Sports Props., Inc.
v. Sportsline.com, Inc., 287 F.3d 1108, 1116 (Fed. Cir. 2002).
In addition, “the prosecution history can often inform the meaning of the claim language.”
Phillips, 415 F.3d at 1317 (Fed. Cir. 2005). For example, it may be used “as support for the
construction already discerned from the claim language and confirmed by the written
description.” 800 Adept, Inc. v. Murex Sec., Ltd., 539 F.3d 1354, 1365 (Fed. Cir. 2008). And

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Courts can consult not only the asserted patent’s prosecution history, but also the prosecution
history of other patents from the same family. See Aventis Pharm. Inc. v. Amino Chems. Ltd.,
715 F.3d 1363, 1375 (Fed. Cir. 2013); Ormco Corp. v. Align Tech., Inc., 498 F.3d 1307, 1314
(Fed. Cir. 2007). Moreover, the prosecution history may serve to “exclude any interpretation
that was disclaimed during prosecution.” Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1384 (Fed.
Cir. 2005). However, a claim should not be narrowed “simply by pointing to the preferred
embodiment or other structures or steps disclosed in the specification or prosecution history.”
CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002).
Finally, extrinsic evidence, such as dictionaries and expert testimony, may be used if the
intrinsic evidence alone is insufficient to determine the meaning of the claim terms. Vitronics,
90 F.3d at 1583.
III.

Analysis
A.

“Neutralizer”

The parties first disagree on the meaning of the term “neutralizer” used in Claim 1 of
the ’568 Patent. Merck suggests that “neutralizer” is “a device that includes an angularly
adjustable plate and a protractor which are used to measure the angle of adjustment to achieve
the neutral position of a specific individual’s ankle.” Def.’s Reply Br. Claim Construction 1-2
(“Def.’s Reply”). ProFoot argues that this term should be given its plain and ordinary meaning
or, if the Court determines that this term needs further construction, that the term be construed as
a “balance measuring device.” Pl.’s Resp. Claim Construction 5 (“Pl.’s Br.”).
The ’568 Patent makes it clear that “neutralizer” does not measure all types of balances.
The Summary of the Invention explains that there are several types of balances and that the
invention deals only with the dynamic one:

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This is the difference between what the present invention achieves
and what many others do in this field. All other alignment
processes implement a two-footed stance to determine the position
of neutrality. . . . If a person is standing on two feet, . . . the person
may be maintaining balance equally in all six quadrants or in one
of the six quadrants and using two others to maintain a steady or
“static” balance.
If you reduce the base of support to only one foot, you have a
three-sided base which needs to articulate to maintain balance or
balance dynamically. The present invention achieves this state by
first analyzing the ankle joint to determine correct foot alignment.
’568 Patent col.2 ll.3-19, J.A. 93. Furthermore, Claim 1 itself provides that “the individual
place[s] the right foot on a neutralizer while elevating the left foot off of the neutralizer.” Id. at
col.5 ll.11-13, J.A. 95. Therefore, a “neutralizer” only deals with one-footed “dynamic” balance.
Next, “neutralizer” is not just any “balance measuring device” as ProFoot contends. It
has specific functions: to accommodate a single foot and to determine the angle necessary to
place the ankle in a neutral position. This is apparent from Claim 1, which covers a method
comprising the steps of “having the individual place the right foot on a neutralizer while
elevating the left foot off of the neutralizer” and “using the neutralizer to determine the angle
necessary to place the right ankle in a neutral position.” Id. at col.5 ll.11-15, J.A. 95 (emphasis
added). Likewise, the Abstract states that “[t]he neutralizer is adapted to accommodate a single
foot of the individual to determine the neutral angle for each foot individually.” Id. at Abstract,
J.A. 89 (emphasis added). The Description of the Preferred Embodiments also explains that in
order “[t]o determine a neutral position, one foot at a time is measured” while “the person stands
on [the] foot neutralizer.” Id. at col.4 ll.5-9, J.A. 94 (emphasis added).
Finally, the “neutralizer” accomplishes its functions by specific structural elements—a
housing, an angularly adjustable plate capable of supporting the foot, and a protractor. Thus, the
Abstract of the ’568 Patent plainly states that “[t]he neutralizer has a housing, protractor, and an
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angularly adjustable plate capable of supporting the foot.” Id. at Abstract, J.A. 89. Nothing in
the specification contradicts this definition. In fact, all embodiments of a “neutralizer” have
these structural elements. Id. at col.3, ll.1-15, J.A. 94.
Such a construction also is supported by the prosecution history of the ’568 Patent’s
parent ’465 Patent. See Biovail Corp. v. Andrx Pharms., Inc., 239 F.3d 1297, 1301 (Fed. Cir.
2001) (considering prosecution history of parent patent in claim construction).

The amended

Claim 1 of the parent application contained the term “neutralizer,” which was described as
“having a housing, protractor, an angularly adjustable plate capable of supporting a foot” and
“adapted to accommodate a single foot of the individual to determine the neutral angle for each
foot of the individual separately.” J.A. 74. This term was used consistently throughout the
prosecution history. The inventor had the opportunity to indicate that the term “neutralizer” as it
appears in the ’568 Patent was somehow different from the term as it was used in the parent
patent, but did not do so.
Of course, “the distinction between using the specification to interpret the meaning of a
claim and importing limitations from the specification into the claim can be a difficult one to
apply in practice.”

Phillips, 415 F.3d at 1323.

ProFoot argues that the ’568 Patent’s

specification supports a broader construction of a “neutralizer” and that reading the term as
having specific structural features improperly limits the claim language to the preferred
embodiment. Pl.’s Br. 8, 11. ProFoot points to the Summary of the Invention, which describes
“a device and method that measures and then corrects the pronation of the foot” and discusses
the method of analyzing the ankle joint to achieve balance. Id. 8. It also argues that the
Description of the Preferred Embodiments depicts only exemplary measuring devices as the

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introduction to the section specifies, pointing to the language in the patent that [f]uture and
present alternatives and modifications are contemplated.” Id. 9.
But claim terms should be read in the context of the entire patent. Phillips, 415 F.3d at
1313. And here, the ’568 Patent as a whole makes it clear that a “neutralizer” is not simply a
“balance measuring device.” The device deals only with dynamic balance; it can accommodate a
single foot and determine the angle necessary to place an ankle in a neutral position. ’568 Patent
col.2 ll.3-19, J.A. 93; col.5 ll.11-15, J.A. 95; Abstract, J.A. 89. Moreover, it is described as
having a housing, a protractor, and an angularly adjustable plate capable of supporting the foot
not only in the Description of the Preferred Embodiments, but also in the Abstract and in the
parent patent application. Id. at Abstract, J.A. 89; J.A. 74. In the face of such intrinsic evidence,
the boilerplate language cited by ProFoot carries little weight. See Wireless Agents LLC v. Sony
Ericsson Mobil Communs. AB¸ 189 F. App’x 965, 967 (Fed. Cir. 2006); IP Innovation, LLC v.
Ecollege.com, 156 F. App’x 317, 321-22 (Fed. Cir. 2005).
Compared to ProFoot’s proposed construction, Merck’s proposal comes closer to the
description above, but does not mention “a housing” and adds the phrase “which are used to
measure the angle of adjustment to achieve the neutral position of a specific individual’s ankle.”
Def.’s Reply 1-2 (stating that “neutralizer” is “a device that includes an angularly adjustable
plate and a protractor which are used to measure the angle of adjustment to achieve the neutral
position of a specific individual’s ankle”).

Merck admits that “the definition previously

expressed by the inventor is narrower than the definition [] proposed by Merck.” Id. 13.
However, it gives no explanation why the definition should not include “a housing,” a structural
element listed in the description of a “neutralizer” in the intrinsic evidence. ’568 Patent Abstract,
J.A. 89; J.A. 74. Next, incorporating the phrase “which are used to measure the angle of

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adjustment to achieve the neutral position of a specific individual’s ankle” in the definition
would result in repetitive language in Claim 1: “using a device that includes an angularly
adjustable plate and a protractor which are used to measure the angle of adjustment to achieve
the neutral position of a specific individual’s ankle to determine the angle necessary to place the
right ankle in a neutral position.” See ’568 Patent col.5 ll.14-15, J.A. 95. Hence, this phrase
should not be included in the definition.
For these reasons, the Court will construe “neutralizer” to mean “a device that has a
housing, a protractor, and an angularly adjustable plate capable of supporting the foot.”
B.

“Neutral position”

The Court next construes the term “neutral position.” Merck proposes that “neutral
position” used in Claim 1 means “a state or position in which the tendons by the individual’s
ankle are in a relaxed state or are working equally.” Def.’s Reply 2. ProFoot counters that the
term should be given its plain and ordinary meaning, which is “balanced position.” Pl.’s Br. 5.
ProFoot’s proposed construction suffers from several deficiencies.

First, the ’568

Patent’s Summary of the Invention reveals that there are several types of balances and balanced
positions. ’568 Patent col.2 ll.3-19, J.A. 93. But the invention concerns only a “dynamic”
balance that is achieved by standing on one foot. Id. In fact, Claim 1 itself states that “neutral
position” is determined when individual places one foot on the neutralizer and elevates another
foot off of the neutralizer. Id. at col.5 ll.11-13, col. 6 ll.3-5, J.A. 95.
Next, “neutral position” corresponds to a specific ankle position or, to be precise, to a
particular subtalar joint 1 position, i.e., the position between pronation and supination. Claim 1

1

A subtalar joint is a joint that allows a foot to move from the orientation where the big toe is over
the smaller toes (called pronation) to the orientation where the smaller toes are over the big toe (called
supination). See ’568 Patent col.1 ll.12-15, J.A. 93 (“the present invention concerns a device and method
that produces an insert or foot support that positions the ankle joint or sub taylor [sic: subtalar] joint in a

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itself states that there is a particular angle that is “necessary to place the right ankle in a neutral
position.” Id. at col.5 ll.14-15, J.A. 95 (emphasis added). Furthermore, the Background of
Invention explains that “the present invention concerns a device and method that produces an
insert or foot support that positions the ankle joint or sub taylor [sic: subtalar] joint in a relaxed
position by correcting the pronation of the foot.” Id. at col.1 ll.12-15, J.A. 93 (emphasis added).
Likewise, the Summary of the Invention discloses that “[t]his invention provides a device and
method that measures and then corrects pronation of the foot.” Id. at col.1 ll.17-18, J.A. 93
(emphasis added). It further elaborates that “[u]nderstanding the demands of skiing specifically
was the thrust behind the invention. . . . If the sub taylor [sic] joint is predisposed with
nonfunctional tension, the ability to move freely will be jeopardized.” Id. at col.1 ll.40-48, J.A.
93 (emphasis added). And, it also points out that “[t]o achieve the proper pronation of the sub
taylor [sic] joint, how the foot is designed to support weight, and walk must be understood.” Id.
at col.1 ll.52-54, J.A. 93 (emphasis added). The discussion of the “dynamic” balance in the
Summary of the Invention is also instructive: “[t]he present invention achieves this state by first
analyzing the ankle joint to determine correct foot alignment.” Id. col.2 ll.17-19, J.A. 93
(emphasis added).
Moreover, the prosecution history reveals the importance of the position of the subtalar
joint.

The ’568 Patent specification is almost identical to the specification of its parent

application, but it contains an important difference; in the ’568 Patent specification, the term
“sub taylor [sic] joint” was added to or replaced the phrase “ankle joint,” indicating that the

relaxed position by correcting the pronation of the foot”); col.4 ll.21-27, J.A. 94 (“To achieve a neutral
position, the operator visually examines the tendons by the ankle until they are in a relaxed state or are
working equally. This commonly occurs with no more than two degrees of adjustment of pronation—
with the big toe of the foot over the smaller toes . . . . However, supination, orientation with smaller toes
over the big toe, may also occur.”).

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inventor wished to describe the relevant joint with greater specificity. Compare id. at col.1 ll.14,
46, 52, J.A. 93, with U.S. Patent No. 6,564,465 col.1 ll.11, 44, 50, J.A. 9.
Merck’s proposed definition (“a state or position in which the tendons by the individual’s
ankle are in a relaxed state or are working equally”) comes from the Description of the Preferred
Embodiments, which states that “neutral position” is achieved when “the tendons by the ankle . . .
are in a relaxed state or are working equally.” ’568 Patent col.4 ll.21-23, J.A. 94. But the Patent
clarifies that “[t]his commonly occurs with no more than two degrees of adjustment of
pronation. . . . However, supination . . . may also occur.” Id. at col.4 ll.23-27, J.A. 94 (emphasis
added). The relaxed state thus comes from the lack of pronation or supination. Add to this the
Summary of the Invention, which explains the cause of the tension (i.e., the unrelaxed state) in
the system:
If the sub taylor [sic] joint is predisposed with nonfunctional
tension, the ability to move freely will be jeopardized. The fine
muscular movements of the foot and ankle dictate the degree of
success in the rest of the biomechanical chain. This is, to a large
extent, the cause of tension or an imbalanced interaction in the
chain.
Id. at col.1 ll.46-51, J.A. 93 (emphasis added). Therefore, the language in the Description of the
Preferred Embodiments that Merck uses for its construction provides further support for the
notion that the “neutral position” corresponds to a subtalar joint position that is between
pronation and supination. In contrast, Merck’s definition draws from the single description of
the embodiment and not from the totality of the intrinsic evidence.
Accordingly, the Court will construe the term “neutral position” to mean “a position in
which subtalar joint is in the relaxed position due to the lack of pronation or supination.”

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C.

“Using the neutralizer to determine the angle necessary to place the <right or
left> ankle in a neutral position”

The next phrase to be construed, “using the neutralizer to determine the angle necessary
to place the <right or left> ankle in a neutral position,” appears in Claim 1 of the ’568 Patent.
Merck asserts that the correct interpretation of the phrase is “using neutralizer by: (1) visually
examining and adjusting the individual’s <right or left> ankle to neutral position, and (2)
measuring the angular degree of pronation or supination when that ankle is in the neutral
position.” Def.’s Reply 2. ProFoot counters that this phrase should be given its plain and
ordinary meaning, that the only term at issue after accepting the construction of “neutralizer” and
“neutral position” is “angle necessary,” and that the term “angle necessary” needs no
independent construction. Pl.’s Br. 6.
Merck’s construction seeks to limit the claims to the preferred embodiment. Its definition
is based on the Description of the Preferred Embodiments, the only place in the patent where the
visual examination is mentioned.

’568 Patent col.4 ll.21-23, J.A. 94.

There is no other

indication in the patent that the use of a “neutralizer” must involve visual inspection. On the
contrary, the ’568 Patent cites U.S. Patent No. 5,979,067, which describes another method to
determine neutral position of a subtalar joint—palpation of the talus head. U.S. Patent No.
5,979,067 col.1 ll.21-28. 2 This intrinsic evidence indicates that a person of ordinary skill in the
art would recognize that visual inspection alone is not the only means to determine the neutral
position of the ankle joint. See Powell v. Home Depot U.S.A., Inc., 663 F.3d 1221, 1231 (Fed.
Cir. 2011) (stating that the prior art cited in a patent or the prosecution history constitutes
intrinsic evidence).

2

Although the parties did not include this patent in the Joint Appendix, the Court may take judicial
notice of published patents under Fed. R. Evid. 201(b) & (c). See Pepitone v. Am. Standard, Inc., No. 921284, 1992 WL 336539, at *3, n.1 (Fed. Cir. Nov. 17, 1992).

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Applying the Court’s definitions of “neutralizer” and “neutral position,” the phrase at
issue becomes “using a device that has a housing, a protractor, and an angularly adjustable plate
capable of supporting the foot to determine the angle necessary to place the <right or left> ankle
in a position in which subtalar joint is in the relaxed position due to the lack of pronation or
supination.” There is no need to define the words “angle necessary.” The two words as they
appear in the Patent are easily understood and do not require interpretation. In context, they
mean the angle measured by the protractor after the angularly adjustable plate is turned to place
the subtalar joint in the relaxed position. See, e.g.,’568 Patent, col.4 ll.21-29, 39-40, J.A. 94
(discussing adjusting the plate to achieve a “neutral position” and measuring the corresponding
angle by the protractor).
D.

“Providing an insert having an angle which represents the neutral state for
the <right or left> ankle”

Merck next suggests that the phrase “providing an insert having an angle which
represents the neutral state for the <right or left> ankle” used in Claim 1 should be interpreted as
“providing an insert that reflects the measured angular degree of pronation or supination of the
individual’s <right or left> foot that establishes the neutral position.” Def.’s Reply 2. ProFoot
replies that the phrase does not require further construction beyond its plain and ordinary
meaning. Pl.’s Br. 6.
This phrase uses the term “neutral state” instead of “neutral position.” The Description
of the Preferred Embodiments connects the two terms. It explains that the neutralizer’s plate is
angularly adjusted “to achieve a neutral position” and the corresponding angle is then transferred
to the “bed,” which is then “placed inside a piece of sports equipment such as ski boot” to hold
the foot “at the angle which is the neutral state for the ankle.” ’568 Patent col.4 ll.4-58, J.A. 94

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(emphasis added). Thus, the ankle is at the same angle on the neutralizer’s plate and on the “bed,”
and, hence, “neutral state” and “neutral position” signify the same position of the ankle.
Therefore, the Court replaces the term “neutral state” with the definition of “neutral
position,” and the phrase “providing an insert having an angle which represents the neutral state
for the <right or left> ankle” becomes “providing an insert having an angle, which represents the
position in which the subtalar joint is in the relaxed position due to the lack of pronation or
supination, for the <right or left> ankle,” which is similar to the Merck’s construction. This
phrase is easily understood. Again, the Court agrees with ProFoot that the term needs no further
construction.
E.

“Predetermined inserts”

Before construing the last disputed term of the independent Claim 1 (“creating a <right or
left> foot insert”), the Court must first examine the term “predetermined inserts” that appears in
dependent Claim 3. Merck argues that the term means “inserts that are pre-made with the
previously measured angle that establishes the neutral position for the individual’s <left or right>
foot.” Def.’s Reply 3. ProFoot again counters that the term needs no further construction
beyond its plain and ordinary meaning. Pl.’s Br. 6.
The key concept in the Merck’s construction is that the fabrication of inserts “is based on
individualized measurement of the individual’s foot and ankle.” Def.’s Reply 10. But “[t]hose
measurements can be stored and used to create an individualized insert at any time,” so
“fabrication of inserts can occur at any time.” Id. Although it is certainly imaginable that one
can save an individual’s measurements to use it later to manufacture an insert, there is nothing in
the intrinsic evidence to suggest this route. Instead, the ’568 Patent’s specification describes
inserts that are pre-made without using a particular individual’s measurements: “the inserts []

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may be pre-made with a range of predetermined angles. For example, insert [] may have an
angle that ranges from ½ a degree to 3 degrees . . . in ½ degree increments. This reduces the
turn-around time to complete the process.” ’568 Patent col.4 ll.61-65, J.A. 94. Merck’s proposed
definition thus ignores important intrinsic evidence. Furthermore, Claim 3 itself states that the
“insert is provided to a user by selecting said insert from a plurality of predetermined inserts.” Id.
at col.6 ll.12-14, J.A. 95 (emphasis added). Under Merck’s definition, the insert would have to
be chosen from the plurality of the same inserts made using individual’s measurement. This
would be a nonsensical result.
Overall, the Court agrees with ProFoot that “predetermined inserts” is an easily
understandable term and does not require further construction beyond its plain and ordinary
meaning.
F.

“Creating a <right or left> foot insert”

Finally, the term “creating a <right or left> foot insert” appears in Claim 1 of the ’568
Patent.

Merck reads this term to mean “fabricating a foot insert based on an operator’s

measurements of the individual’s <right or left> foot.” Def.’s Reply 2. ProFoot replies that the
term needs no further construction beyond its plain and ordinary meaning or, in alternative, that
“creating” should be construed as “determining a right or left insert.” Pl.’s Br. 6.
Merck’s construction hinges on the idea that the insert is made using individualized
measurements. Def.’s Reply 10. Specifically, Merck points out that in Claim 1 “the three substeps that follow the term[] . . . indicate that inserts are to be fabricated to have an angle that
represents the neutral position.” Def.’s Opening Claim Construction Br. 19. Merck further
refers to the specification, which discusses the importance of measuring each foot independently,

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evaluating pronation, and positioning the ankle in a relaxed position by correcting the pronation
of the foot. Id. 20.
As an initial matter, the Court agrees that the phrase “creating a <right or left> foot insert”
encompasses fabricating an insert based on the individual’s measurements. But that is not all
that the term encompasses. Dependent Claim 3 states that the insert can be “provided to a user
by selecting said insert from a plurality of predetermined inserts.” ’568 Patent col.6 ll.12-14, J.A.
95. This means that “creating” must also include a scenario where a “predetermined insert” is
provided to a user. This interpretation is further supported by the patent’s specification, which
describes both, making an insert using individual’s measurements and pre-making inserts “with a
range of predetermined angles.” Id. at col.4 ll.28-55, 61-64, J.A. 94.
The plain and ordinary meaning of “create” (e.g., “to cause to come into being”)
encompasses both scenarios and is consistent with the entirety of the ’568 Patent, not just the
excerpts selected by Merck. See Pl.’s Br. 18. (suggesting that “create” broadly means “to cause
to come into being”). Therefore, the Court agrees with ProFoot that the term does not require
construction.
IV.

Terms as Construed

#

Term

Definition

I

“Neutralizer”

“A device that has a housing, a protractor,
and an angularly adjustable plate capable
of supporting the foot”

II

“Neutral position”

“A position in which subtalar joint is in
the relaxed position due to the lack of
pronation or supination”

III

“Using the neutralizer to determine the No construction required once the
angle necessary to place the <right or left> definitions of the terms “neutralizer” and
ankle in a neutral position”
“neutral position” are applied.

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IV

“Providing an insert having an angle which No construction required once “neutral
represents the neutral state for the <right or state” is replaced with the definition of the
left> ankle”
“neutral position.”

V

“Predetermined inserts”

No construction required.

VI

“Creating a <right or left> foot insert”

No construction required.

For the foregoing reasons, the six disputed claim terms are construed as set forth in this
Memorandum Opinion and Order.
IT IS SO ORDERED.

ENTERED

6/17/15

_________________________
John Z. Lee
United States District Judge

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