Bonutti Skeletal Innovations v. DePuy Mitek, Inc.

Filing 74

Judge Richard G. Stearns: ORDER entered. MEMORANDUM AND ORDER on claim construction. "The claim terms at issue will be construed for the jury and any other purpose in this litigation in a manner consistent with the above rulings of the court." (RGS, int2)

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
CIVIL ACTION NO. 12-11667-RGS
BONUTTI SKELETAL INNOVATIONS
v.
DEPUY MITEK LLC, et al.
MEMORANDUM AND ORDER ON CLAIM CONSTRUCTION
May 02, 2014
STEARNS, D.J.
In this intellectual property dispute, plaintiff Bonutti Skeletal Innovations (BSI)
accuses defendants DePuy Mitek LLC, DePuy Institute LLC, DePuy Inc., and DePuy
Orthopaedics, Inc. (collectively DePuy) of infringing U.S. Patents Nos. 5,527,343 (the
’343 patent), 5,718,717 (the ’717 patent), 5,980,559 (the ’559 patent), 7,087,073 (the
’073 patent), 6,702,821 (the ’821 patent), 7,806,896 (the ’896 patent), and 8,133,229
(the ’229 patent). DePuy counterclaims for declarative judgment of invalidity and noninfringement of the seven asserted patents. Before the court are the parties’ briefs on
claim construction. The court heard argument, pursuant to Markman v. Westview
Instruments, Inc., 517 U.S. 370 (1996), on May 1, 2014.
BACKGROUND
The seven asserted patents name Dr. Peter Bonutti, an orthopedic surgeon, as

their inventor, and fall into two categories. The ’821,’896, and ’229 patents disclose
methods relating to knee-replacement (arthroplasty) surgery, and the ’343, ’717, ’559,
and ’073 patents disclose suture anchors and suturing methods. BSI avers that it is the
owner, by assignment, of the asserted patents.
The Knee-Replacement Surgery Patents1
The ’896 and ’229 patents are both entitled “Knee Arthroplasty Method,” and
were respectively issued on October 5, 2010, and March 13, 2012. The two patents
share largely the same specification, and disclose improved methods for less invasive
knee-replacement surgery.
With known techniques, the patella is commonly everted from its normal
position. When the patella is everted, the inner side of the patella is
exposed and faces outward away from end portions of the femur and tibia.
The outer side of the everted patella faces inward toward the end portions
of the femur and the tibia. Moving the everted patella to one side of end
portions of the femur and tibia tends to increase the size of the incision
which must be made in the knee portion of the patient’s leg.
’229 patent, col. 2, ll. 19-27. The ’229 patent claims methods for performing kneereplacement surgery that offsets, rather than everts, the patella, and therefore may
decrease the size of the incision necessary in the patient’s leg.

Claim 18 is

representative:
1

The ’821 patent is entitled “Instrumentation for Minimally Invasive Joint
Replacement and Methods for Using Same,” and was issued on March 9, 2004. The
parties do not dispute the construction of any claim terms in the ’821 patent.
2

18. A method of performing a joint arthroplasty surgery on a leg
of a patient through an incision in a knee portion of the leg, comprising:
displacing a patella in the knee portion of the leg from a normal
position to an offset position with an articulating surface of the
patella facing the femur;
positioning a guide assembly proximally to the patella, the guide
assembly including a pair of substantially parallel arms and a
slot having a guide surface configured for receiving a patella
cutting tool;
cutting the inner side of the patella, using the guide assembly, in
the knee portion of the leg, prior to resecting the femur or the
tibia, while the articulating surface of the patella faces towards
a posterior portion of the knee portion of the leg, and includes
removing at least a portion of the articulating surface of the
patella; and
connecting at least one patella implant to the cut articulating
surface of the patella,
wherein the cut articulating surface of the patella faces towards a
posterior portion of the knee portion of the leg when the at least
one patella implant is connected.
(emphases added to highlight disputed claim term).
The ’896 patent claims methods for using guides to direct bone cutting. Claim
13 is representative:
13. A method of replacing at least a portion of a joint in a patient,
the method comprising the steps of:
obtaining a customized cutting guide fabricated for the patient
based on preoperative information, the cutting guide
3

positionable in a pre-determined position on a bone of the joint
using references derived independently from an intramedullary
device;
making an incision adjacent to the joint in the patient;
positioning the cutting guide in the pre-determined position by
passing the cutting guide through the incision and on a surface
of an end portion of an unresected bone of the joint;
moving a cutting tool through the incision into engagement with a
guide surface on the positioned cutting guide;
cutting the unresected bone of the joint for the first time, by
moving the cutting tool along the guide surface;
attaching a replacement portion of the knee to the cut surface, the
replacement portion having a transverse dimension that is larger
than a transverse dimension of the guide surface; and
disposing of the cutting guide, as it is no longer safely usable the
bone for which it was custom fabricated having been cut and
therefore changed.
(emphasis added).
The Suture Anchor Patents2
The ’559 patent is entitled “Suture Anchor” and was issued on November 9,
1999. The ’559 patent discloses a suture anchor that is at least partly formed from a
material that absorbs body liquid and expands while in the body, thereby helping to
2

The ’343 and ’717 patents are both entitled “Suture Anchor,” and were
respectively issued on June 18, 1996, and February 17, 1998. The parties do not
dispute the construction of any claim terms in these two patents.
4

retain the suture anchor within the patient’s body. Claims 24 and 34 are representative.
24. An apparatus which is at least partially received in body tissue,
said apparatus comprising suture means for transmitting tension forces,
and suture anchor means connected with said suture means for retaining
at least a portion of said suture means against movement relative to body
tissue under the influence of tension in said suture means, said suture
anchor means being at least partially formed of a material which absorbs
body liquid and expands while said suture anchor means is disposed in
body tissue, said suture anchor means includes a side portion which
extends between opposite end portions of said suture anchor means, said
suture anchor means includes means for defining a passage having first
and second openings in said side portion of said suture anchor means, said
suture means being partially disposed in said passage between said first
an [sic] second openings.
34. An apparatus which is at least partially received in body tissue,
said apparatus comprising suture means for transmitting tension forces,
and suture anchor means connected with said suture means for retaining
at least a portion of said suture means against movement relative to body
tissue under the influence of tension in said suture means, said suture
anchor means being at least partially formed of a material which absorbs
body liquid and expands while said suture anchor means is disposed in
body tissue, said suture anchor means includes surface means for piercing
an imperforate surface area on body tissue.
(emphases added).
The ’073 patent is entitled “Method of Securing Body Tissue,” and was issued
on August 8, 2006. The ’073 patent discloses methods for securing two body tissues
by placing suture anchors within one body tissue, tensioning and connecting the
sutures, and transmitting the tension through the suture to another body tissue. Claim
35 is representative:
5

35. A method of securing first body tissue with second body
tissue, said method comprising the steps of moving a first anchor along a
first path into the second body tissue with a first suture portion extending
from the first anchor, moving a second anchor along the second path into
the second body tissue with a second suture portion extending from the
second anchor, tensioning the first and second suture portions,
determining when a predetermined tension is present in the first and
second suture portions during performance of said step of tensioning the
first and second suture portions, interconnecting the first and second
suture portions after determining that the predetermined tension is present
in the first and second suture portions, and transmitting force through the
suture to the first body tissue.
(emphases added).
DISCUSSION
Claim construction is a question of law for the determination of the court. See
Markman, 517 U.S. at 388-389. Claim terms are generally given their ordinary and
customary meaning 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, 1312-1313 (Fed. Cir. 2005) (en
banc) (citations omitted). “The person of ordinary skill in the art is deemed to read the
claim term . . . in the context of the entire patent, including the specification.” Id. at
1313.
The patent 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.” Id. at 1315, quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d

6

1576, 1582 (Fed. Cir. 1996). Because the purpose of the specification is to “teach and
enable those of skill in the art to make and use the invention and to provide the best
mode for doing so,” Phillips, 415 F.3d at 1323, it is “entirely appropriate for a court,
when conducting claim construction, to rely heavily on the written description for
guidance as to the meaning of the claims.” Id. at 1317.
In addition to the patent’s specification, the prosecution history “can often
inform the meaning of the claim language by demonstrating how the inventor
understood the invention and whether the inventor limited the invention in the course
of prosecution, making the claim scope narrower than it would otherwise be.” Id.
Although not as reliable as the patent and its prosecution history, the court may also
consider extrinsic evidence “if the court deems it helpful in determining the true
meaning of language used in the patent claims.” Id. at 1318. Ultimately, “[t]he
construction that stays true to the claim language and most naturally aligns with the
patent’s description of the invention [in the specification] will be, in the end, the correct
construction.” Id. at 1316.
1. ’229 patent – “articulating surface of the patella”
BSI proposes that “articulating surface of the patella” should be given its
ordinary meaning because that is how the phrase is used in the patent. DePuy contends
that the “articulating surface of the patella” must be in its “native uncut state” because
7

where the claims of ’229 patent refer to the surface after it has been cut, the term is
qualified by “cut.” See, e.g., ’229 patent, claim 18. BSI objects to the insertion of an
extraneous limitation into this claim term, and the court agrees. The claims refer to the
“cut articulating surface of the patella” only after specifying a cutting step. See id.
Nothing in the patent or the prosecution history would mandate that the “articulating
surface of the patella” must be in a “native uncut state” (or any particular state) prior
to the specified cutting step. Indeed, as BSI points out, inserting the “native uncut”
requirement would exclude surgical procedures on previously operated-upon patellas,
an exclusion nowhere supported by the intrinsic evidence.
Defendants have, since their opening brief, withdrawn their proposal that the
“articulating surface of the patella” be construed as the “inner surface of the patella.”
As the term is not one of common parlance, defendants’ original instinct that it would
be helpful to the jury to have the “articulating surface of the patella” defined, however,
is sound. The court largely agrees with defendants’ original position – the “articulating
surface of the patella” is the “inner side of the patella.”
In describing the procedures for everting and not everting the patella during
knee-replacement surgery, the ’229 patent uses the terms “inner side” and “outer side”
to describe the two sides of the patella:
[a]fter the incision 114 has been elastically expanded, a patella 120 and
8

tissue on the lateral side of the incision may be everted in a manner
illustrated in FIG. 7. Thus, the patella 120 is moved from the normal
orientation of FIG. 6 to the everted or flipped orientation of FIG. 7,
preferably while the leg 70 of the patient is in the extended orientation
of FIG. 7. At this time, the inner side 122 of the patella 120 is facing
outward away from other bones in the knee portion 76. The outer side
of the everted patella 120 is facing inward toward other bones in the
knee portion 76. This enables the inner side 122 of the patella 120 to be
examined.
...
If desired, the foregoing step of inverting the patella 120 may be omitted.
The patella 120 may be left in orientations in which the inner side 122
of the patella faces inward throughout the operation. If this is done, the
inner side 122 of the patella 120 may be inspected by tilting the patella
from its normal orientation and/or using viewing devices, such as an
endoscope. Regardless of how the inner side 122 of the patella 120 is
inspected, moving the patella to the offset position of FIG. 8, with the
inner side 122 facing inward, facilitates utilization of an incision 114
having a limited length.
’229 patent, col. 15, l. 60 - col. 16, l. 27 (emphases added). Later, in describing the
eversion procedure and referring to the same numbered element in the figures, the
patent uses the terms “inner side” and “articular surface” interchangeably: “[t]he inner
side or articular surface 122 of the patella 120 faces outward and is exposed.” Id. col.
29, ll. 55-57 (emphasis added).
BSI contends that because claim 18 of the ’229 patent recites both the
“articulating surface of the patella” and the “inner side of the patella”, the two terms
must be distinct. Although ordinarily it is true that the use of two different terms in the
same claim refers to two different elements, see Ethicon Endo-Surgery, Inc. v. U.S.
9

Surgical Corp., 93 F.3d 1572, 1579 (Fed. Cir. 1996), claim 18 is only logically sound
if the two terms are one and the same, as reflected in the specification. The claim
recites “displacing a patella . . . with an articulating surface of the patella facing the
femur,” then specifies “cutting the inner side of the patella,” and later refers to “the cut
articulating surface of the patella.” Without understanding the “inner side of the
patella” to refer to the “articulating surface of the patella,” the “cut articulating surface
of the patella” would have no rational antecedent. See Philips, 415 F.3d at 1327
(“[C]laims should be construed, if possible, as to sustain their validity.”).
BSI also relies on the declaration of its expert witness for the arthroplasty
patents, Dr. Scott Schoifet, for the proposition that the “articulating surface of the
patella” is not the “inner side of the patella.” However, where the intrinsic record is
clear, as it is here, it is unnecessary for the court to turn to extrinsic evidence. See
Victronics, 90 F.3d at 1584 (“Only if there were still some genuine ambiguity in the
claims, after consideration of all available intrinsic evidence, should the trial court have
resorted to extrinsic evidence, such as expert testimony, in order to construe claim 1.
Moreover, even if the judge permissibly decided to hear all the possible evidence
before construing the claim, the expert testimony, which was inconsistent with the
specification and file history, should have been accorded no weight.”). Finally, Dr.
Schoifet’s opinion is contradicted by the established medical dictionary definition.
10

Consistent with the use in the ’229 patent, the “articular surface of the patella” is
defined as “the posterior surface of the patella.” Stedman’s Medical Dictionary (27th
ed. 2000). Thus, the court construes the “articulating surface of the patella” as
referring to the “inner side of the patella.”3
2. ’896 patent – “customized cutting guide fabricated for the patient”
BSI also proposes that “customized cutting guide fabricated for the patient” be
given its ordinary meaning because the phrase is given its common meaning in the
patent. DePuy contends, based on the dictionary definition of “customize,” that a
“customized cutting guide fabricated for the patient” is “a cutting guide made or altered
in any way for a specific patient.” BSI objects because the phrase “altered in any way”
suggests that any minor adjustment made to a cutting guide would suffice, which
contradicts the meaning of the word “fabricate” in the claim term. BSI also points out
that during prosecution, the patentee argued to the PTO that “‘custom fabricated’ is
clearly distinct from ‘adjusted,’”4 Pl. Ex. 3, Response to Final Office Action,
November 25, 2003, at 11, thereby excluding the mere adjustment to a cutting guide
3

The court will accept, as the parties proposed during oral argument, an agreedupon definition of the term “articulating” as used in the context of the ’229 patent.
4

The court does not consult the prosecution history to establish prosecution
history disclaimer, that is, to “limit the meaning of a claim term that would otherwise
be read broadly,” but to confirm the ordinary meaning of the claim term. See 800
Adept, Inc. v. Murex Sec., Ltd., 539 F.3d 1354, 1364 (Fed. Cir. 2008).
11

from the scope of this claim term.
The court agrees with BSI that DePuy’s proposed “altered in any way”
construction unjustifiably broadens the common understanding of the word “fabricate.”
Nothing in the patent suggests that “fabricate” is used in any but its ordinary sense.
Without “an express intent to impart a novel meaning,” the words of this claim term,
being unspecialized and non-technical, should be given their ordinary meaning in the
English language. Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed.
Cir. 2002). Thus, the court construes “customized cutting guide fabricated for the
patient” as having its ordinary meaning – “a cutting guide constructed or manufactured
for a specific patient.”
3. ’559 patent – “suture anchor means”
DePuy contends, and BSI disagrees, that “suture anchor means” is a means-plusfunction claim term subject to analysis under 35 U.S.C. § 112(f). Subsection (f)
provides that
[a]n element in a claim for a combination may be expressed as a means
or step for performing a specified function without the recital of structure,
material, or acts in support thereof, and such claim shall be construed to
cover the corresponding structure, material, or acts described in the
specification and equivalents thereof.
The application of subsection (f) “operates to restrict claim limitations drafted in such
functional language to those structures, materials, or acts disclosed in the specification
12

(and their equivalents) that perform the claimed function.” Personalized Media
Commc’ns, LLC v. Int’l Trade Comm’n, 161 F.3d 696, 703 (Fed. Cir. 1998).
As DePuy points out, “[a] claim limitation that actually uses the word ‘means’
will invoke a rebuttable presumption that § 112[(f)] applies.” CCS Fitness, Inc. v.
Brunswick Corp., 288 F.3d 1359, 1369 (Fed. Cir. 2002). However, the means-plusfunction presumption may be overcome if the claim “goes on to elaborate sufficient
structure, material, or acts within the claim itself to perform entirely the recited
function.” Personalized Media, 161 F.3d at 704, citing Sage Prods. v. Devon Indus.,
Inc., 126 F.3d 1420, 1427-1428 (Fed. Cir. 1997). To determine whether subsection (f)
is invoked “involves an analysis of the patent and the prosecution history, and
consulting a dictionary definition of [the disputed claim term] to understand if one of
skill in the art would understand this term to connote structure.” Personalized Media,
161 F.3d at 704. Ultimately, “[i]n deciding whether either presumption has been
rebutted, the focus remains on whether the claim as properly construed recites
sufficiently definite structure to avoid the ambit of [subsection (f)].” Id.
BSI argues, and the court agrees, that the recitation of “suture anchor” provides
sufficient structure to overcome the means-plus-function presumption. The ’559 patent
is entitled “Suture Anchor” and its specification discusses the material and structures
of various suture anchors already known in the art. See, e.g., ’559 patent, col. 2, ll. 3913

48 (“Suture anchors have previously been utilized to retain sutures in either hard or soft
tissue in a human patient’s body. The suture anchors have previously been formed of
metal, biodegradable materials, and other materials. These known suture anchors
have been retained in the patient’s body by changing the orientation of the anchor
relative to the patient’s body once it has been inserted into the patient’s body.
Alternatively, known anchors have been retained in the patient’s body by a
mechanical interlock formed with the material of the patient’s body by barbs or other
projections.”) (emphasis added).
The claims of the ’559 patent disclose additional structural elements to “suture
anchor means.”

For example, claim 24 describes the “suture anchor means” as

“connected with said suture means . . . being at least partially formed of a material
which absorbs body liquid and expands while said suture anchor means is disposed in
body tissue, said suture anchor means includes a side portion which extends between
opposite end portions of said suture anchor means . . . [and] includes means for
defining a passage . . . .” The parties agree that if “suture anchor means” were to be
a means-plus-function claim term, its function would be “retaining at least a portion of
a suture against movement relative to body tissue under the influence of tension in the
suture.” It is clear that “material which absorbs body liquid and expands while said
suture anchor means is disposed in body tissue” performs this function. See
14

Personalized Media, 161 F.3d at 704.
Professor Stephen Belkoff, BSI’s expert witness for the suture anchor patents,
opines that “one of ordinary skill in the art would have understood [] that ‘suture
anchor’ is a commonly used term that refers to any number of different structures.” Pl.
Ex. 9 ¶ 21. The opinion is supported by the use of “suture anchor” independent of
“means,” without challenge from DePuy, in the claims of the asserted ’073 patent,
another patent implicating the same art. Because “suture anchor means” recites
sufficient structure – “suture anchor” – as would be understood by a person of ordinary
skill in the art, it is not subject to 35 U.S.C. § 112(f). The court construes “suture
anchor means” as “suture anchor.”5
4. ’559 patent – “means for defining a passage having first and second
opening in said side portion of said suture anchor means”
The parties agree that “means for defining a passage having first and second
opening in said side portion of said suture anchor means” is a means-plus-function
element subject to analysis under 35 U.S.C. § 112(f). The parties further agree that the
function of the claim term is “defining a passage.” BSI contends that the structure of

5

Like some of her colleagues, the drafter of the ’559 patent was evidently
“enamored of the word ‘means.’” Cole v. Kimberly-Clark Corp., 102 F.3d 524, 531
(Fed. Cir. 1996).

15

this claim term is “all suture anchor structures disclosed in the specification that have
first and second opening in a side portion of the suture anchor and structural
equivalents.” DePuy contends that the structure is “tunnel in suture anchor, in the
shapes disclosed in figure 9 and col. 11:7-10, and structural equivalents of the
foregoing.” In essence, the parties agree that the structure 30d disclosed in figure 9 of
the ’559 patent is within the ambit of this claim term, but dispute whether structure 30e
of figure 10 is. Both figures are reproduced below:

DePuy is right that structure 30e does not correspond with a “means for defining
a passage having first and second opening in said side portion of said suture anchor
means.” The “side portion” of the “suture anchor means” “extends between opposite
end portions of said suture anchor means,” and “the means for defining a passage [has]
first and second openings in said side portion of said suture anchor means.” ’559
patent, claim 24. The openings of passage 30e are not in a side portion of the suture

16

anchor that “extends between opposite end portions,” rather “passage 30e is formed
in a projection 164 which extends axially outward from the end wall 162.” Id., col. 12,
ll. 10-12.
BSI argues that passage 30e should be included in the construction of “means
for defining a passage . . .” because it is a structural equivalent of passage 30d. Under
35 U.S.C. § 112(f), “the claim shall be construed to cover the corresponding structure,
material, or acts described in the specification and equivalents thereof.” (emphasis
added). While BSI may be right that passage 30e is structurally equivalent6 to passage
30d, this is not an inquiry for the court during claim construction. The determination
of equivalence for analysis of infringement is a task for the jury (or the court at the
summary judgment stage if there are no genuine disputes of material facts). See
Warner-Jenkinson Co., Inc. v. Hilton Davis Chem. Co., 520 U.S. 17, 38 (1997). Thus,
the court will not expand its role at claim construction and identify potential equivalents
of structure 30d. The court construes “means for defining a passage having first and
second opening in said side portion of said suture anchor means” as “a passage having
first and second opening in a side portion of the suture anchor, in the shapes disclosed

6

The statutory equivalence analysis under §112(f) is narrower than the general
doctrine of equivalence in that it requires functional identity before engaging in an
analysis of whether there are insubstantial differences in the “way” and the “result.”
Odetics, Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1267 (Fed. Cir. 1999).
17

in figure 9, and col. 11:7-10, and structural equivalents thereof.”
5. ’559 patent – “surface means for piercing an imperforate surface area
on body tissue”
The parties also dispute whether “surface means for piercing an imperforate
surface area on body tissue” is subject to analysis under 35 U.S.C. § 112(f). As with
“suture anchor means,” DePuy argues that the use of “means” in this term triggers the
means-plus-function presumption, which cannot be overcome because the claim term
does not primarily recite structure. BSI contends, and the court agrees, that the
recitation of “surface” provides sufficient structure to this claim term.
In Cole, the Court of Appeals for the Federal Circuit agreed that “perforation
means” was not a means-plus-function claim element because “perforation” is
commonly understood as a structural element, namely “a hole, or one of a number of
holes, bored or punched through something, as those between individual postage
stamps of a sheet to facilitate separation.” Cole, 102 F.3d at 531, quoting Webster’s
Encyclopedic Unabridged Dictionary (1989). As in Cole, the parties here do not
contend that “surface” is used in any way other than its ordinary meaning. The
dictionary defines “surface” as “the outer face, outside, or exterior boundary of a thing;
outermost or uppermost layer or area.” Random House Unabridged Dictionary (2d
ed. 1993). “Surface” clearly “connote[s] structure,” Personalized Media, 161 F.3d at

18

704, and read in the context of the claims, “surface means” refers to the surface of the
suture anchor.7 The court construes “surface means for piercing an imperforate surface
area on body tissue” as “surface for piercing an imperforate surface area on body
tissue.”
6. ’073 patent – “predetermined tension”
BSI proposes that “predetermined tension” should be given its ordinary meaning
because the phrase is used in its common sense in the patent. DePuy contends that a
“predetermined tension” is “a specific tension measurement that is determined prior to
tensioning the suture portions.” For support, DePuy first points to the claim language,
which requires “tensioning the first and second suture portions” and then “determining
when a predetermined tension is present . . . during performance of said step of
tensioning . . . .” ’073 patent, claim 35. Logically, DePuy argues, a practitioner of the
method must have a specific tension measurement in mind before tensioning. DePuy
also relies on passages in the specification that describe how to measure the
“predetermined tension force” using a load cell or other transducer. See, e.g., id. col.
8, ll. 45-47; col. 29, ll. 42-44. The ’073 patent also discloses a force application
assembly wherein the tension measurement device is associated with the suture

7

DePuy does not challenge that the other use of surface in the same claim term
– “an imperforate surface area on body tissue” – connotes structure.
19

insertion device, so that the tension may be measured as the suture is inserted into the
patient. Id. col. 36, ll. 48-54; col. 37, ll. 5-12.
BSI objects, and the court agrees, that the ’073 patent does not require that the
“predetermined tension” be a specific measurement. Although DePuy is correct that
the claim language specifying “determining when a predetermined tension is present”
requires that the “predetermined tension” be known in advance, it does not imply that
the tension is necessarily a specific measurement. BSI suggests that a range is also
conceivable – and nothing in the patent rules out that possibility. It is similarly true that
the specification of the ’073 describes several embodiments where the tension is
measured, or where a predetermined amount of tension is applied to the suture portions
by a force application assembly. However, “it is improper to read limitations from a
preferred embodiment described in the specification – even if it is the only embodiment
– into the claims absent a clear indication in the intrinsic record that the patentee
intended the claims to be so limited.” Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d
898, 913 (Fed. Cir. 2004).
BSI also argues that “a specific tension measurement” is too narrow a
construction because the ’073 patent describes that tensioning may be accomplished
manually, and DePuy has no proposal for how to achieve a specific tension
measurement manually. “The two leg portions of the suture would be tensioned after
20

the anchors 18e and 20e had moved into the body tissue 14e. This could be
accomplished manually or by the use of a force application assembly. . . .” ’073
patent, col. 41, ll. 12-14 (emphasis added). Based on this passage, BSI contends that
a predetermined tension may be achieved manually based on a surgeon’s experience,
such as a person may use tactile feedback to tie her shoelaces.
The court disagrees. DePuy correctly points out that the ’073 patent claims both
tensioning sutures generally (e.g., claim 6) and also tensioning sutures to a
“predetermined tension,” and that the former is a broader limitation than the latter. In
describing the former, the patent describes tensioning the sutures when “the surgeon
pulls on the free end of the legs portions 50 and 52 and moves the retainer 54 toward
the body tissue 12.” Id. col. 27, ll. 49-51. However, only specialized equipment is
described when obtaining a “predetermined tension.” In the passage that follows the
reference to manual tensioning, “predetermined tension” is established using a force
application assembly and not manually:
[t]he two leg portions of the suture would be tensioned after the anchors
18e and 20e had moved into the body tissue 14e. This could be
accomplished manually or by the use of a force application assembly,
corresponding to the force application assembly 60 of FIG. 10. In this
situation, a force application member, corresponding to the force
application member 66 of FIG. 10 may be utilized to press the retainer
against the body tissue. While the suture 24e is being tensioned with a
predetermined force and while the retainer is being pressed against the
body tissue with a predetermined force, force application members,
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corresponding to force application members 76 and 78 of FIG. 10,
would be utilized to effect deformation of the retainer.
Id. col. 41, ll. 12-24, (emphasis added).
Although tensioning may certainly be performed manually, there is no support
in the patent for tensioning to a “predetermined tension” based on tactile feedback
while tensioning. In the court’s experience, a person will know when a shoe is
comfortably laced to the right tension when she gets there, but will not know in
advance what that tension is until she gets there. The critical understanding then, is that
the “predetermined tension” must be known in advance. Thus, the court construes
“predetermined tension” as having its ordinary meaning – “a tension that is determined
in advance of (and not during) tensioning the suture portions.”
CONCLUSION
The claim terms at issue will be construed for the jury and any other purpose in
this litigation in a manner consistent with the above rulings of the court.
SO ORDERED.
/s/ Richard G. Stearns
_______________________________
UNITED STATES DISTRICT JUDGE

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