Ethicon Endo-Surgery, Inc. v. Covidien, Inc.

Filing 212

ORDER Resolving Motions for Summary Judgment (Docs. 184, 186, 188, 192). Signed by Judge Timothy S. Black on 5/17/19. (rrs)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF OHIO
WESTERN DIVISION
ETHICON ENDO-SURGERY, INC., et
al.,
Plaintiffs,
vs.
COVIDIEN, INC., et al.,
Defendants.

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Case No. 1:11-cv-871
Judge Timothy S. Black

ORDER RESOLVING MOTIONS FOR
SUMMARY JUDGMENT (Docs. 184, 186, 188, 192)
This civil action is before the Court on the Plaintiffs Ethicon Endo-Surgery, Inc.
and Ethicon Endo-Surgery, LLC (collectively, “Ethicon”)’s motion for summary
judgment of infringement (Doc. 186) and the parties’ responsive memoranda (Docs. 199,
210); and Defendants Covidien Sales LLC, Covidien LP, and Covidien Inc. (collectively,
“Covidien”)’s motion for summary judgment of invalidity and non-infringement of U.S.
Patent No. 9,168,055 (Doc. 188) and the parties’ responsive memoranda (Docs. 201,
208). Also before the Court are Ethicon’s motion for summary judgment of absence of
acceptable and available non-infringing alternatives (Doc. 184) and the parties’
responsive memoranda (Docs. 203, 209); and Covidien’s motion for partial summary
judgment precluding lost profits damages (Doc. 192) and the parties’ responsive
memoranda (Docs. 198, 207).

I.

BACKGROUND

The devices at issue are ultrasonic instruments used in open and laparoscopic
surgical procedures to cut and coagulate tissue and vessels, thereby helping to control
bleeding and achieve hemostasis. Ethicon manufactures a line of ultrasonic surgical
devices under the “Harmonic” brand. Ethicon’s products use blades oscillating at
extremely high speeds to make surgical procedures easier and safer, reducing damage to
surrounding tissue, causing less bleeding, and generally allowing for better surgical
outcomes than other methods of incision. Ethicon holds a portfolio of patents covering
its Harmonic line. Covidien manufactures a laparoscopic, ultrasonic dissection device
sold under the name “Sonicision.” Ethicon contends that the Sonicision device infringes
on Ethicon’s U.S. Patent No. 9,168,055 (the “‘055 Patent”)
This case has a long procedural history before this Court. Ethicon initially filed
suit against Covidien in 2011 alleging violation of several patents. Following discovery,
the Court granted summary judgment in favor of Covidien on the issues of both
noninfringement of the patents at issue and invalidity of certain patents. (See Docs. 130,
131, 132, 133, 134). On appeal, the Federal Circuit Court of Appeals reversed this
Court’s rulings in part, holding that none of the patents at issue were invalid, but
upholding the Court’s findings of noninfringement as to some of the patents. Ethicon
Endo-Surgery, Inc. v. Covidien, Inc., 796 F.3d 1312 (Fed. Cir. 2015).
Following the Federal Circuit’s ruling, Covidien filed a separate suit seeking a

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declaratory judgment of noninfringement of six of Ethicon’s patents. Ethicon filed a
counterclaim alleging infringement of seven of its patents. That action was consolidated
with the current action. Subsequently, the parties resolved and mutually agreed to
dismiss all claims from each party relating to all patents, except for the ‘055 Patent.
Ethicon contends that Covidien has infringed the ‘055 Patent. Covidien claims
that the ‘055 Patent is invalid for lack of written description, is invalid for obviousness,
that the Sonicision device does not infringe on the ‘055 Patent because the Sonicision
device exerts clamping pressure outside of the range claimed by the ‘055 Patent, and that
six asserted claims1 of the ‘055 Patent are not infringed because the Sonicision device
does not apply a predetermined force or pressure.
II.

UNDISPUTED FACTS2

A. The ‘055 Patent
The current dispute between Ethicon and Covidien relates to the validity and

1

The six claims are 1, 2, 4, 5, 8, and 14, which include the requirement that the clamping arm
exert a “predetermined” force or pressure. While Ethicon maintains that the Sonicision device
infringes on these claims, Ethicon does not base its motion for summary judgment of
infringement on these six claims. (Doc. 186 at 4).
2

Pursuant to the Standing Order of the Court, Ethicon and Covidien filed Statements of
Proposed Undisputed Facts and responses to the proposed statements for their respective
motions. The Court's statement of facts set forth here incorporates the facts undisputed by the
parties and the facts confirmed by the Court upon review of the citations to the evidentiary
record provided by the parties. (See Ethicon’s Statement of Undisputed Facts (“ESUF”): Docs.
186-1 and 201-1 at 98–185, Docs. 200 and 208-1; Covidien’s Statement of Undisputed Facts
(“CSUF”): Doc. 190, Doc. 201-1; Ethicon’s Damages Statement of Undisputed Facts
(“EDSUF”): Doc. 184-1, Doc. 2014; Covidien’s Damages Statement of Undisputed Facts
(“CDSUF”): Doc. 194, Doc. 198-1).

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infringement of the ‘055 Patent, titled “Ultrasonic Surgical Shears and Method for
Sealing a Blood Vessel Using Same.” The ‘055 patent is a direct continuation of the U.S.
Parent No. 8,460,326 (the “‘326 Patent”), which is a direct continuation of U.S. Patent
No. 8,182,501 (the “‘501 Patent”). The ‘055, ‘326, and ‘501 Patents are members of the
same patent family and have identical specifications. (ESUF at ¶ 7; CSUF at ¶¶ 8, 16).
The claims of the ‘501 and ‘055 Patents differ in several ways, including: (1) the ‘501
Patent recites a pressure range of 60 to 210 pounds per square inch (“psi”), while the ‘055
Patent claims a range of 120 to 210 psi; (2) each claim of the ‘501 Patent recites a
“predetermined force” but claims 9, 10, and 20–25 in the ‘055 Patent do not contain a
“predetermined” limitation; (3) the ‘501 Patent uses means-plus-function language to
describe the structure that limits the clamping force, while the ‘055 Patent recites a
“spring.” (ESUF at ¶ 7).
The ‘055 Patent was filed on May 17, 2013 as Application No. 13/896,380. The
‘055 Patent was issued on October 27, 2015 and has a priority date of February 27, 2004,
the filing date of U.S. Provisional Application No. 60/548,308. (ESUF at ¶ 6; CSUF at
¶¶ 6–7).
The Background of the Invention of the ‘055 Patent provides in part:
Ultrasonic surgical instruments are known which include
ultrasonic surgical shears having an ultrasonic surgical blade,
a clamping arm operable to open and close toward the blade,
a tissue pad attached to the clamping arm and including a
0.033 square-inch clamping surface area, and a device for
exerting a 1.5 pound clamping force on the clamping arm

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which creates a clamping pressure of 45 psi (pounds per
square inch) on a blood vessel which is positioned between
the clamping surface area of the tissue pad and the blade. It is
noted that the clamping surface area is the area where the
blade and the tissue pad are in close proximity when the
clamping arm is in a closed position. Exemplary devices are
described in U.S. Pat. Nos. 5,322,055 and 6,325,811, the
contents of which are incorporated herein by reference. The
result of the ultrasonically-vibrating ultrasonic surgical blade
and the clamping pressure on the blood vessel is a coaptation
of the blood vessel (a bringing together of the walls of the
blood vessel), a transection (a cutting) of the coaptated blood
vessel, and a coagulation (a sealing) of the coaptated cut ends
of the blood vessel. It is known that blood-vessel transection
times can be decreased with the application of a higher
clamping force. However, this is not done because
conventional thought is that decreasing the blood-vessel
transection time using a higher clamping force will lead to a
degradation in coagulation performance (i.e., a lowering of
the burst pressure of a sealed end of the transected blood
vessel). Conventional ultrasonic surgical shears are not used
on blood vessels larger than 3mm because the clamping force
used is inadequate for proper coaptation.
(Doc. 202-3 (“‘055 Patent”), col. 1:30-56).
The Summary of the Invention of the ‘055 Patent provides in part:
Several benefits and advantages are obtained from one or
more of the method and the embodiments of the invention.
Exerting an ultrasonic surgical shears coaptation pressure
from 60 psi to 210 psi provides for improved blood vessel
sealing with shorter transection times on 3 mm or smaller
blood vessels than conventionally is possible and provides for
blood vessel sealing with acceptable transection times and
burst pressures on blood vessels larger than 3mm, which is
not conventionally possible. Applicants experimentally found
that applying an ultrasonic surgical shears coaptation pressure
ranging from 60 psi to 210 psi (corresponding to a fullyengaged clamping surface area of 0.033 square inches and a

5

clamping force ranging from 2 to 7 pounds) on 4.5 mm to 5
mm diameter blood vessels resulted in successful bloodvessel sealing with transection times of 2 to 4 seconds and
with burst pressure of generally 500 to 700 mmHg compared
to a transaction [sic] time of over 9 seconds and a burst
pressure of generally 100 mmHg for a 45 psi clamping
pressure (corresponding to a fully-engaged clamping surface
are of 0.033 square inches and a clamping force of 1.5
pounds). Applicants also experimentally found that applying
an ultrasonic surgical shears coaptation pressure ranging from
120 psi to 180 psi (corresponding to a fully engaged clamping
surface are of 0.033 square inches and a clamping force
ranging from 4 to 6 pounds) on 5 mm to 7 mm diameter blood
vessels resulted in successful blood-vessel sealing with
transection times of 1.5 to 2.0 seconds and with burst
pressures of generally 500 mmHg compared to a transaction
[sic] time of generally 4.5 seconds and a burst pressure of
generally 30 mmHg for a 45 psi clamping pressure
(corresponding to a fully-engaged clamping surface are of
0.033 square inches and a clamping force of 1.5 pounds).
(Id., col. 2:24–55).
While Ethicon contends that the Sonicision device infringes on claims 1, 2, 4, 5, 8,
9, 10, 14, and 20–25, Ethicon’s motion is limited to claims 9, 10, and 20–25 of the ‘055
Patent. (ESUF at ¶ 40). Ethicon asserts that claims 9, 22, and 24 are representative of the
claims asserted in this motion. (Id. at ¶ 41).3
Claim 9 of the '055 Patent reads:
9. An ultrasonic surgical shears comprising:
Covidien does not dispute that “9, 22 and 24 of the ’055 patent ‘are representative of the claims
asserted in this motion,’ to the extent that claims 9, 22 and 24 do not recite “predetermined”
force or pressure claim elements, as compared to claims 1, 2, 4, 5, 8, and 14, which are not
asserted in Ethicon’s summary judgment motion. Covidien otherwise disputes the
characterization of claims 9, 22 and 24 as ‘representative’ of ’055 patent claims 9–10 and 20–
25.” (Doc. 200 at ¶ 41).
3

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a) an ultrasonic surgical blade;
b) a clamping arm operable to open and close toward
the blade;
c) a tissue pad attached to the clamping arm; and
d) a spring for limiting an average clamping force,
wherein the blade and tissue pad define a clamping
surface area and the average clamping force provides
for an average clamping pressure between and
including 120 psi and 210 psi at the clamping surface
area.
(Doc. 202-3 (‘055 Patent), col. 8:13-23).
Claim 22 of the '055 Patent provides:
22. An ultrasonic surgical shears comprising:
a) an ultrasonic surgical blade;
b) a clamping arm operable to open and close toward
the blade;
c) a tissue pad attached to the clamping arm, wherein
the blade and tissue pad define a clamping surface area
when the blade and the tissue pad are in close
proximity; and
d) a spring for limiting a clamping force, wherein the
clamping force divided by the clamping surface area is
between and including 120 psi and 210 psi on tissue
disposed on the clamping surface area.
(Id., col. 8:27–36).
Claim 24 of the '055 Patent provides:
24. An ultrasonic surgical shears comprising:
a) an ultrasonic surgical blade;
b) a clamping arm operable to open and close toward
the blade;
c) a tissue pad attached to the clamping arm; and
d) a spring for transferring a clamping force, wherein
the blade and tissue pad define a clamping surface area
and wherein the spring transfers a clamping force to

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obtain a clamping pressure between and including 120
psi and 210 psi at the clamping surface area.
(Id., col. 8:27-36.)
On March 12, 2017, the parties agreed to a construction for the claim term “is preloaded” as follows:
Claim Term
is pre-loaded (claims 21, 23, 25)

Construction
possesses a loading force before use

(ESUF at ¶ 45).
On April 10, 2017, the Court entered an Order on Claim Construction construing
two additional claim terms as follows:
Claim Term
spring (claims 1, 9, 14, 20–25)

Construction
no construction is necessary4

“predetermined average coaptation
pressure” (claim 1) / “predetermined
clamping force” (claim 14)

clamping (pressure/force) set in advance of
operating the clamping arm or clamping
(pressure/force) set by the user prior to
operating the clamping arm.

(Doc. 176).
In discussing clamping pressures, the ‘055 Patent states: “The pressures discussed
herein are pressures seen by tissue when the entire clamping surface area is in contact
with the tissue. As previously mentioned, a clamping surface area is the area where the
blade and tissue pad are in close proximity when the clamping arm is in a closed

4

The Court noted that "[t]he ordinary meaning of the term 'spring' is apparent, and the
inventor did not specifically define the term or disavow its customary meaning, either expressly
or in context." (Doc. 176 at 9).

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position.” (‘055 Patent, col. 4:23–27).
Below, Figure 2 of the ‘055 Patent depicts ultrasonic surgical shears (18), means
(28) for exerting a clamping force on the clamping arm (22), tissue pad (24), and blade:

(Id. at col. 4:33–37). In referencing Figure 2 of the ‘055 Patent, the 055 Patent
specification states: “The ultrasonic surgical shears 18 also includes means 28 for
exerting a clamping force on the clamping arm 22 creating a clamping pressure between
and including 60 psi and 210 psi on tissue disposed between the tissue pad 24 and the
blade 20.” (Id.)
Below, Figure 3 of the ‘055 Patent depicts ultrasonic surgical shears (30), means
(40) for limiting a user-applied clamping force on the clamping arm (34), tissue pad (36),
and a blade (32):

9

(Id., Fig. 3). In referencing Figure 3, the ‘055 Patent states: “The ultrasonic surgical
shears 30 also includes means 40 for limiting a user-applied clamping force on the
clamping arm 34 creating a clamping pressure between and including 60 psi and 210 psi
on tissue disposed between the tissue pad 36 and the blade 32.” (Id., col. 5:4–8).
The below Figure 4 from the ‘055 patent shows a cross-sectional view of a tissue
pad (26) and blade (20), with the maximum width of each denoted by the arrows “Wp”
(for pad width) and “Db” (for blade diameter or width), respectively:

(Id., Fig. 4; ESUF ¶¶ 131–132).

10

Figure 5 of the ‘055 Patent also includes the following cross-sectional figure of an
ultrasonic shears, which shows the blade (120), tissue pad (124), clamping surface area
(127), and clamping arm (122):

(Id., Fig. 5).
B. Sonicision Device
Covidien’s Sonicision devices at issue have the following products codes: SCD13,
SCD26, SCD391, SCD396, and SCD48. (ESUF at ¶ 20). While the different product
codes have different shaft lengths, for the purpose of these motions, these Sonicision
devices are the same in all relevant aspects. (Id. at ¶ 21). As shown below, each
Sonicision device includes a blade, a clamping arm, a wave guide within inner and outer
tubes, a handle (in the form of a “Shepherd’s hook”), a force spring, a rotation knob, and
an activation button.

11

(Id. at ¶ 18). In use, a physician operates the Sonicision device by pulling on the trigger
to open and close the clamp arm, and applies ultrasonic energy through the use of the
activation button. (Id.)

12

A cross-sectional view of Sonicision’s blade and opposing tissue pad on the clamp
arm is shown below:

(CSUF at ¶¶ 64–65).
At Covidien’s expert’s deposition, Dr. William Durfee identified what he
considered to be Sonicision’s “rounded tip” and “slanted side,” which were considered in
his calculation of clamping surface area.

(ESUF at ¶ 105).
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III.

STANDARD OF REVIEW

A motion for summary judgment should be granted if the evidence submitted to
the Court demonstrates that there is no genuine issue as to any material fact, and that the
movant is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(a); see Celotex
Corp. v. Catrett, 477 U.S. 317, 322 (1986); Anderson v. Liberty Lobby, Inc., 477 U.S.
242, 247–48 (1986). The moving party has the burden of showing the absence of
genuine disputes over facts which, under the substantive law governing the issue, might
affect the outcome of the action. Celotex, 477 U.S. at 323. All facts and inferences must
be construed in a light most favorable to the party opposing the motion. Matsushita Elec.
Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986).
A party opposing a motion for summary judgment “may not rest upon the mere
allegations or denials of his pleading, but . . . must set forth specific facts showing that
there is a genuine issue for trial.” Anderson, 477 U.S. at 248 (1986).
“When reviewing cross-motions for summary judgment, [courts] must evaluate
each motion on its own merits and view all facts and inferences in the light most
favorable to the nonmoving party.” Appoloni v. United States, 450 F.3d 185, 189 (6th
Cir. 2006). “When a district court denies summary judgment to one party on the ground
that it is granting summary judgment to another party, the denial of summary judgment is
based on a legal conclusion rather than the district court’s finding of a genuine issue of
material fact.” Westfield Ins. Co. v. Tech Dry, Inc. 336 F.3d 503, 506 (6th Cir. 2003).

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On cross-motions for summary judgment on the same issue, “if there is no genuine
dispute and one or the other party is entitled to prevail as a matter of law, the court will
render judgment.” 10A Fed. Prac. & Proc. Civ. § 2720 (4th ed.).
IV.

INFRINGEMENT AND VALIDITY ANALYSIS (Docs. 186, 188)

Before addressing Covidien’s argument that the ‘055 Patent is invalid, the Court
will analyze whether the Sonicision devices infringe on the ‘055 Patent.
A.

Infringement of the ‘055 Patent

Ethicon moves for summary judgment of infringement on claims 9, 10, and 20–25
of the ‘055 Patent. (Doc. 186). Covidien cross-moves for summary judgment of
noninfringement of all claims of the ‘055 patent on the grounds that the Sonicision exerts
clamping pressure outside of the claimed 120 to 210 psi pressure range, and additionally
moves for summary judgment of noninfringement of claims 1, 2, 4, 5, 8, and 14 on the
grounds that Sonicision does not practice the predetermined limitation recited in those
claims. (Doc. 189 at 39–45).
Determining infringement consists of two steps. The Court must (1) first interpret
the claim, and (2) then compare the properly construed claims to the alleged infringing
device. SafeTCare Mfg., Inc. v. Tele-Made, Inc., 497 F.3d 1262, 1268 (Fed. Cir. 2007).
To establish infringement of a patent, every limitation set forth in a claim must be found
in an accused product or process exactly or by a substantial equivalent. Johnston v. IVAC
Corp., 885 F.2d 1574, 1577 (Fed. Cir. 1989) (citing Corning Glass Works v. Sumitomo

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Elec. U.S.A., Inc., 868 F.2d 1251, 1259 (Fed. Cir. 1989). Thus, if the accused product
fails to meet even a single claim limitation, then there can be no literal infringement as a
matter of law. Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1247 (Fed. Cir.
2000). The motion of an accused infringer for summary judgment on the ground of noninfringement of a patent may be granted where the patentee’s proof is deficient in
meeting an essential part of the legal standard for infringement. Johnston, 885 F.2d at
1577 (citing Townsend Eng’g Co. v. HiTec Co., 829 F.2d 1086, 1089 (Fed. Cir. 1987)).
Ethicon is entitled to summary judgment of infringement if it shows that there is
no genuine dispute of material fact that every limitation in the contested claims is found
in the Sonicision device. Covidien is entitled to summary judgment of noninfringement
if Ethicon has failed to proffer evidence to support a finding that a limitation of the
asserted claim was met by the structure in the Sonicision device.
a. Infringement by Sonicision – Clamping Pressure
Ethicon contends that the ‘055 Patent represents an important advancement in the
field of ultrasonic surgical devices because the inventors of the ‘055 Patent discovered
that using higher clamping pressures in the claimed range of 120 to 210 psi, in contrast to
the 60 to 210 psi range included in the ‘501 Patent, led to fast and effective vessel
sealing, including for larger vessels. (‘055 Patent, col. 2:24–55). All of the asserted
claims of the ‘055 Patent require clamping pressure less than or equal to 210 psi at the
clamping surface area. Ethicon argues that Covidien’s Sonicision devices infringe on the

16

‘055 Patent because Sonicision exerts clamping pressures in the 120 to 210 psi pressure
range. Covidien, on the other hand, argues that the Sonicision devices exert clamping
pressure outside of the claimed 120 to 210 psi pressure range.
The parties’ experts agree that the Sonicision device includes each element of
claims 9, 10, 20–25 except for the clamping pressure limitation. (ESUF ¶ 63). There is
no dispute that clamping pressures claimed in the ‘055 Patent are calculated by dividing
clamping force by the relevant clamping area. (CSUF at ¶¶ 59–60). There is no dispute
that clamping force must be measured at the midpoint of the clamping surface area.
(CSUF ¶¶ 117–18, 122–23). Dr. Durfee, Covidien’s expert, testified that he agreed with
and used the force measurements of Karl Leinsing, Ethicon’s expert. (Doc. 186-3
(“Durfee Tr.”) at 76:15–77:3)

There is no dispute that the claimed clamping pressures

are measured when the clamping arm and blade are in a closed position. (CSUF ¶¶ 118–
19, 121, 124). The only dispute between the parties relates to the relevant clamping
surface area. (Doc 186 at 11; Doc. 189 at 35). Indeed, the parties even agree on the
length measurements of the clamping surface area (ESUF at ¶ 95); the parties’ only
disagreement is how to measure the width.
Ethicon contends that the width of the clamping surface area is measured using the
entire width of the tissue pad and includes both where the blade and tissue pad are in
direct contact and where the blade and tissue are in close proximity. (ESUF ¶ 104).
Covidien, on the other hand, contends that the width of the clamping surface area is

17

measured using the width of the rounded tip of the Sonicision device. (CSUF at ¶ 127).
The ‘055 Patent specification defines “clamping surface area” as “the area where
the blade and the tissue pad are in close proximity when the clamping arm is in a closed
position.” (‘055 Patent, col. 1:30–56). In its 2015 decision, the Federal Circuit cited the
same portion of the ‘501 Patent specification, which is identical to the ‘055 Patent, to
note that the “specification explains that this ‘clamping surface area is the area where the
blade and the tissue pad are in close proximity because the arm is in a closed position.’”
Ethicon Endo-Surgery, Inc. v. Covidien, Inc., 796 F.3d 1312, 1317 (Fed. Cir. 2015)
(quoting the ‘501 Patent).
Covidien points to the Federal Circuit language that the clamping surface area is
“defined by the tissue pad and the blade.” Id. Covidien uses this language to argue that
the teachings of the ‘055 Patent and the Federal Circuit’s decision support its position
that “the clamping surface area of the Sonicision device must be defined by the contact
area between the blade’s rounded tip and the tissue pad, when the clamping arm is in the
closed position.” (Doc. 189 at 36). However, accepting Covidien’s preferred definition
of clamping surface area would interpret the “close proximity” language out of the ‘055
Patent entirely. For that reason, the Court finds that the teachings of the ‘055 Patent and
the Federal Circuit’s decision make clear that the clamping surface area is “defined by the
tissue pad and the blade” where the blade and the tissue pad are in close proximity.

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Having found that Ethicon properly interpreted the ‘055 Patent’s teachings on how
to calculate the clamping surface area, the Court finds that there are no disputed facts that
the Sonicision devices infringe on the clamping pressure range of the ‘055 Patent. As
noted, the only disputed fact was how to measure the width of the clamping surface area.
Covidien’s expert noted that his only disagreement with Ethicon’s expert’s measurement
of the clamping surface area was the width. (Durfee Tr. at 116:9–23). At his deposition,
Dr. Durfee acknowledged that the maximum width of the Sonicision blade is wider than
the tissue pad. (Durfee Tr. at 142:21–25). Indeed, Dr. Durfee recognized that
Sonicision’s blade and tissue pad are in close proximity for the entire tissue pad, not just
the rounded tip. (See id. at 136:3–9). Thus, Dr. Durfee should have measured the
clamping surface area of the Sonicision device by using the width of the entire tissue pad.
Because Dr. Durfee’s calculation of clamping surface area was based on an improper
interpretation of the ‘055 Patent, his calculation of clamping pressure is inaccurate.
Mr. Leinsing, Ethicon’s expert, used the proper methodology to calculate
clamping surface area, defined by where the blade and the tissue pad are in close
proximity. Mr. Leinsing’s calculations of the clamping surface area of the Sonicision
device are shown in the table below
Sonicision Product
No.
SON-13-1
SON-13-2
SON-13-3
SON-26-1

Active Pad
Length (in.)
0.599
0.600
0.600
0.600

Pad Width (in.)
0.050
0.051
0.051
0.050

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Clamping Surface
Area (in2)
0.029950
0.030600
0.030600
0.030000

Sonicision Product
No.
SON-26-2
SON-26-3
SON-39-1
SON-39-2
SON-39-3
SON-48-1
SON-48-2
SON-48-3

Active Pad
Length (in.)
0.600
0.599
0.601
0.600
0.600
0.602
0.600
0.600

Pad Width (in.)
0.051
0.051
0.051
0.050
0.051
0.051
0.051
0.051

Clamping Surface
Area (in2)
0.030600
0.030549
0.030651
0.030000
0.030600
0.030702
0.030600
0.030600

(Doc. 186-7 (“Leinsing Report”) at ¶ 49)
Mr. Leinsing then used his accurate calculation of the Sonicision devices’
clamping surface area to calculate the Sonicision devices’ clamping pressure. He found
that the Sonicision devices exert clamping pressures in the 120 to 210 psi pressure range;
this range is within the clamping pressure limitation of the ‘055 Patent. The clamping
pressure calculations are shown in the table below.
Sonicision Product
No.
SON-13-1
SON-13-2
SON-13-3
SON-26-1
SON-26-2
SON-26-3
SON-39-1
SON-39-2
SON-39-3
SON-48-1
SON-48-2
SON-48-3

Clamping Pressure (calculated using the
measured clamping force) (lbs./in2, psi)
168.95
158.41
171.02
154.69
167.91
162.34
142.16
150.05
151.58
154.83
153.70
132.16

Clamping Force
(measured) (lbs.)
5.1
4.8
5.2
4.6
5.1
5.0
4.4
4.5
4.6
4.8
4.7
4.0

(Leinsing Report at ¶ 59)

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This clamping pressure range for the Sonicision device infringes on the ‘055
Patent. Accordingly, the Court finds that Ethicon has shown that there is no genuine
issue of material fact that the Sonicision devices infringe on claims 9, 10, and 20–25 of
the ‘055 Patent.
Therefore, Ethicon’s motion for summary judgment of infringement (Doc. 186) is
GRANTED and Covidien’s motion for summary judgment of noninfringement (Doc.
188) is DENIED in part to the extent that Covidien claims the Sonicision device does
not infringe on any of the ‘055 Patent’s claims because the Sonicision device exerts
clamping pressure outside of the claimed 120 to 210 psi pressure range.
b. Infringement by Sonicision – Predetermined Force (Claims 1, 2, 4,
5, 8, and 14)
Covidien moves for summary judgment of noninfringement of claims 1, 2, 4, 5, 8,
and 14 of the ‘055 Patent on the grounds that the Sonicision device does not practice the
“predetermined” limitation. Covidien notes that the Court, during the ‘501 Patent
litigation, determined that the Sonicision device did not infringe the ‘501 Patent because
the clamping force that the Sonicision device exerts is not predetermined. (Doc. 131 at
42–44). Covidien argues that because Ethicon did not appeal that noninfringement
determination (see Ethicon, 796 F.3d at 1314–15) to the Federal Circuit, the Court’s
decision regarding noninfringement due to failure to satisfy the “predetermined”
limitation is controlling. See Del Mar Avion, Inc. v. Quinton Instrument Co., 836 F.2d
1320, 1323 (Fed. Cir. 1987) (“The prior determination of certain issues, including the

21

issues of claim construction and of infringement by the type A and non-infringement by
the type C models, bars judicial redetermination of those issues as between the parties to
the prior actions.”).
To invoke issue preclusion a party must establish four preconditions: “(1) identity
of the issues in a prior proceeding; (2) actual litigation of those issues; (3) necessity of the
prior determination to the resulting judgment; and (4) full and fair opportunities to litigate
issues for the party defending against preclusion.” Sacramento Mun. Util. Dist. v. United
States, 566 F. App'x 985, 993–94 (Fed. Cir. 2014). Covidien argues that all
preconditions are met here because the same construction of the term “predetermined” is
before the Court as was during the litigation of the ‘501 Patent and the same structures of
the Sonicision devices that were accused of infringing the ‘501 Patent are accused of
infringing the ‘055 Patent. (Doc. 189 at 40).
Ethicon argues that issue preclusion does not apply because this Court’s ‘501
patent noninfringement determination was effectively overturned by the Federal Circuit.
Issue preclusion “should not be applied to foreclose full consideration of an issue when
there has been a significant change in decisional law between the first case and the
second.” Sacramento Mun. Util. Dist. V. United States, 566 Fed. App’x 985, 994 (Fed.
Cir. 2014). The Court has already rejected Ethicon’s similar argument in finding that the
Federal Circuit’s ruling did not have any impact on this Court’s previous term
construction related to the “predetermined” limitation in the Order on Claim

22

Construction. (Doc. 176 at 10–12).
The Court agrees with Covidien that all of the preconditions of collateral estoppel
are met here. Moreover, consistent with its earlier Order (Doc. 131 at 42–44), the Court
finds that the Sonicision device does not exert a “predetermined” force. In order to exert
a predetermined force, a device must be set to a value within the claimed pressure range,
independent of user control. While the minimum and maximum range of the pressure is
determined before the Sonicision device is used, (Durfee Tr. At 181:25-182:21), the
clamp force for the Sonicision device varies depending on how hard the surgeon
squeezes.
The Court finds that the Sonicision device does not practice the “predetermined”
limitation set forth in claims 1, 2, 4, 5, 8, and 14 of the ‘055 Patent. Accordingly,
Covidien’s motion for summary judgment of noninfringement (Doc. 188) is GRANTED
in part to the extent that the Sonicision device does not infringe on claims 1, 2, 4, 5, 8,
and 14 of the ‘055 Patent.
B.

Validity of ‘055 Patent

Next, Covidien moves for summary judgment of invalidity of the ‘055 Patent.
(Doc. 189 at 29–33). Significantly, the ‘055 Patent is presumed valid. 35 U.S.C § 282.
Covidien argues that the ‘055 Patent is invalid for failing to comply with the written
description requirement (35 U.S.C. § 112) and for obviousness (35 U.S.C. § 103(a)).

23

1. Written Description
The specification of a patent “shall contain a written description of the invention,
and of the manner and process of making and using it.” 35 U.S.C. § 112 ¶ 1. “A party
must prove invalidity for lack of written description by clear and convincing evidence.”
Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 682 (Fed. Cir. 2015).
“Compliance with the written description requirement is a question of fact but is
amenable to summary judgment in cases where no reasonable fact finder could return a
verdict for the nonmoving party.” PowerOasis, Inc. v. T–Mobile USA, Inc., 522 F.3d
1299, 1307 (Fed. Cir. 2008). “Thus, a moving party seeking to invalidate a patent at
summary judgment must submit such clear and convincing evidence of invalidity so that
no reasonable jury could find otherwise.” Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d
955, 962 (Fed. Cir. 2001)
“[T]he hallmark of written description is disclosure.” Ariad Pharm., Inc. v. Eli
Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). Id. The standard for satisfying the
written description requirement is whether the disclosure “allow[s] one skilled in the art
to visualize or recognize the identity of the subject matter purportedly described.” Enzo
Biochem, Inc. v. Gen–Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002). To determine
whether the written description requirement is met, the Court must consider “whether the
disclosure of the application relied upon reasonably conveys to those skilled in the art
that the inventor had possession of the claimed subject matter as of the filing date.”

24

Ariad, 598 F.3d at 1351. This test “requires an objective inquiry into the four corners of
the specification from the perspective of a person of ordinary skill in the art. Based on
that inquiry, the specification must describe an invention understandable to that skilled
artisan and show that the inventor actually invented the invention claimed.” Id.
a. The Messerly Patent is incorporated by reference in the ‘055 Patent
It is undisputed that the ‘055 Patent specification describes an ultrasonic surgical
shears that includes a spring. (ESUF at ¶ 436). However, Covidien argues that the ‘055
Patent does not disclose any spring for “limiting force” (claims 1, 2, 4, 5, 8–10, 14, 20–
23) or “transferring force” (claims 24, 25) and is therefore invalid for lack of written
description. Ethicon contends that the Messerly Patent (‘811 Patent),5 which discloses
the claimed springs for limiting a clamping force, is part of the disclosure of the ‘055
Patent and thus provides adequate written description. The Court agrees with Ethicon.
The Messerly Patent was prior art to the ‘055 Patent. (CSUF ¶¶ 74–75). The ‘055
Patent specification provides: “Exemplary devices are described in U.S. Pat. Nos.
5,322,055 and [the Messerly Patent], the contents of which are incorporated herein by
reference.” (‘055 Patent at col. 1:41–43). Covidien and Covidien’s expert have both
recognized that the Messerly Patent is incorporated into the disclosure of the ‘055 Patent
in its entirety. (ESUF ¶¶ 314–15, 326). Thus, the Court finds that it is undisputed that

Ethicon patent, U.S. Patent No. 6,325,811 to Messerly (the “Messerly Patent” or the “‘811
Patent), was filed on October 5, 1999 and is prior art to the ‘055 Patent. (CSUF ¶¶ 74–75).
5

25

the Messerly Patent was incorporated by reference in the ‘055 Patent specification. See
X2Y Attenuators, LLC v. ITC, 757 F.3d 1358, 1362–63 (Fed. Circ. 2011) (when a patent
is incorporated by reference, “[t]he incorporated patents are ‘effectively part of the host
[patents] as if [they] were explicitly contained therein.’”) (quoting Telemac Cellular
Corp. v. Topp Telecom, Inc., 247 F.3d 1316, 1329 (Fed. Cir. 2001)).
b. Spring for limiting force/transferring force
Covidien concedes that the Messerly Patent discloses a force limiting spring,
(Doc. 191-14 at col. 7:55–8:29), and a spring for transferring force. (Id. at 7:61–63).
Covidien’s expert also recognizes that the Messerly Patent includes a “force-limiting
spring” and “force-transferring spring.” (ESUF ¶¶ 354, 359). Yet Covidien argues that
the ‘055 Patent specification, on its face, does not teach one of ordinary skill to employ
the Messerly Patent as a force limiting or force transferring spring, but instead describes
Messerly in connection with a spring creating force.
Covidien cites the Federal Circuit’s decision in Tronzo v. Biomet, Inc., 156 F.3d
1154 (Fed. Cir. 1998) in arguing that Ethicon cannot properly rely on the Messerly
Patent’s incorporation by reference into the ‘055 Patent. Id. at 1160 (“the district court
properly rejected [expert’s] reliance on an incorporation by reference of a [prior art]
patent” to satisfy written description requirement). Yet the facts in Tronzo are easily
distinguished from those currently before the Court.
In Tronzo, the Federal Circuit denied a foreign patentee the priority date from its

26

parent application. Id. at 1159. The patent at issue in that case related to artificial
hip sockets including cup implants adapted for insertion into a hip bone. Id. at 1156. The
parent application had described only conical cups, while the later United States patent
application disclosed hemispherical cups. The patent holder argued that the foreign
patent application had described a number of cups, thus generically claiming
hemispherical cups. Id. The Federal Circuit rejected this argument because the parent
application emphasized that the conical shape was “extremely important,” and only
referenced non-conical cups to distinguish the conical cups as superior. Id. Because of
this, the Federal Circuit found that the foreign application contained no reference to the
later-claimed hemispherical cups and limited the earlier invention to conical cups.
Notably, in Tronzo the only mention of non-conical shaped cups was to emphasize
that conical shaped cups were superior to prior art. Here, if the Messerly Patent had
disclosed that springs for limiting / transferring clamping force would be inferior to other
springs, and then Ethicon tried to rely on that language to argue that the ‘055 Patent
disclosed springs for limiting / transferring force by incorporating the Messerly Patent,
Tronzo would be informative. However, Ethicon contends that the ‘055 Patent provides
adequate written description of a spring for limiting / transferring force because the
Messerly Patent, which was incorporated into the ‘055 Patent, clearly describes the use of
springs for limiting and transferring clamping force.
The Court finds that the Messerly Patent discloses both a spring to limit a

27

clamping force and a spring to transfer a clamping force. The Court also finds that the
Messerly Patent is broadly and unequivocally incorporated into the disclosure of the ‘055
Patent in its entirety. Accordingly, the Court finds that ‘055 Patent specification
discloses a spring that limits force and a spring that transfers force and complies with the
written description requirement of 35 U.S.C. § 112.
Moreover, in its Order on Claim Construction, the Court found that the ordinary
meaning of “the term ‘spring’ is apparent, and the inventor did not specifically define the
term or disavow its customary meaning.” Similarly, the Court finds that a reasonable
juror could find that one of ordinary skill in the art would understand that springs both
limit and transfer force.
The Court cannot find that Covidien has provided such clear and convincing
evidence of invalidity of the ‘055 Patent for lack of written description that no reasonable
juror could find otherwise. Accordingly, Covidien’s motion for summary judgment that
the ‘055 Patent is invalid for lack of written description is DENIED.
2. Obviousness
Obviousness is a question of law based on underlying facts. Kinetic Concepts,
Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1356–57 (Fed. Cir. 2012). “To prevail on
obviousness, an alleged infringer must prove by clear and convincing evidence ‘that a
skilled artisan would have been motivated to combine the teachings of the prior art
references to achieve the claimed invention, and that the skilled artisan would have had a

28

reasonable expectation of success in doing so.” Eli Lilly & Co. v. Teva Pharm. USA,
Inc., 566 F.3d 989, 994 (Fed. Cir. 2009). In conducting an obviousness analysis, a court
“must guard against ‘hindsight bias’ and ‘ex post reasoning.’” St. Jude Med., Inc. v.
Access Closure, Inc., 729 F.3d 1369, 1381 (Fed. Cir. 2013).
Secondary considerations or objective indicia of non-obviousness are important in
an obviousness analysis. Apple Inc. v. Samsung Elecs. Co., Ltd., 839 F.3d 1034, 1052
(Fed. Cir. 2016). Secondary considerations serve to guard against hindsight bias. Id.
Secondary considerations include: “commercial success enjoyed by devices practicing
the patented invention, industry praise for the patented invention, copying by others, and
the existence of a long-felt but unsatisfied need for the invention.” In Stratoflex, Inc. v.
Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir. 1983), the Federal Circuit held:
Indeed, evidence of secondary considerations may often be
the most probative and cogent evidence in the record. It may
often establish that an invention appearing to have been
obvious in light of the prior art was not. It is to be considered
as part of all the evidence, not just when the decisionmaker
remains in doubt after reviewing the art.
Id. at 1538.
Covidien contends that all claims of the ‘055 Patent are obvious because the only
claim Ethicon contends to be missing from the prior art – the higher clamping pressure of
120 to 210 psi – is insufficient to confer patentability over prior art. Where the difference
between a claimed invention and prior art is a range within the claims “the applicant must
show that the particular range is critical, generally by showing that the claimed range

29

achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d
1575, 1578 (Fed. Cir. 1990).
Covidien argues that there is no genuine issue of material fact that: (1) a person of
ordinary skill in the art would be motivated to apply higher pressures in the claimed 120
to 210 psi range with a reasonable expectation of success; (2) the 120 to 210 psi clamping
pressure range is not critical to vessel sealing with ultrasonic surgical instruments,
including on 5mm blood vessels up; and (3) the inventor’s experiments with clamping
pressures in the 120 to 210 psi range did produce not produce unexpected results as of
February 2004. (Doc 189 at 29). Contrarily, Ethicon argues that Covidien’s obviousness
analysis is tainted with improper hindsight and ignores undisputed evidence.
Ultimately, the Court finds that, while Covidien raises several issues of fact
indicating that the ‘055 Patent may be invalid for obviousness, Covidien has not shown
obviousness by clear and convincing evidence. Ethicon points to several material facts
such that a reasonable juror could find that the ‘055 Patent was non-obvious. (Doc. 201
at 16–25).
First, Ethicon provides evidence to support its contention that a person of ordinary
skill in the art at the time of the invention would not have been motivated to combine the
teachings of the cited prior art to apply a clamping pressure in the claimed range,
including: Dr. Durfee testified that it was known in February of 2004 that increasing
clamping pressure could have poor effect on vessel sealing (Durfee Tr. at 219:21–

30

220:18); and a book published in 2005 (“Feil”) includes a chapter entitled “Principles of
Ultrasonic Energy for Cutting and Coagulating” that includes the figure below that
associates “faster cutting” with “less hemostasis” and “slower cutting” with “more
hemostasis.”

(See ESUF at ¶¶ 365–66). Both of these facts cast doubt on the proposition that a person
of ordinary skill in the art would be motivated to apply higher clamping pressures with a
reasonable expectation of success. Ethicon also raises issues on whether U.S. Patent
Application No. 2003/0055417, “Surgical System for Applying Ultrasonic Energy to
Tissue” (“Truckai”), relied upon by Covidien for the proposition that “one of ordinary
skill in the art at the time of the invention would have naturally been motivated to apply
higher pressures to prior art” (Doc. 189 at 29–30), actually teaches away from pursuing
higher forces and pressures found in the ‘055 Patent. (See Doc. 201 at 18–21). Overall,

31

the Court finds that Ethicon has raised issues of material fact on whether a person of
ordinary skill in the art would be motivated to apply higher pressures in the claimed 120
to 210 psi range with a reasonable expectation of success.
Second, to dispute that the ‘055 Patent’s claimed pressure range of 120 to 210 psi
is not critical, Ethicon cites to the testimony of the inventor of the ‘055 Patent and Mr.
Leinsing that that pressure in the 120 to 210 psi range performed better than pressures in
the 60 to 119 range. (Doc. 201-12 (“Houser Tr.”) at 941:3–8; Doc. 201-13 (“Leinsing
Tr.”) at 139:10–23). This testimony indicates that there is a genuine issue of material fact
of whether the pressure range of 120 to 210 psi provides optimal performance or is
critical, which would render the ‘055 Patent non-obvious.
Third, while Covidien’s argument that 120 to 210 psi range was not critical
because it was found through “trial and error” (CSUF ¶ 220) has some merit, see KSwiss, Inc. v. Glide N Lock GmbH, 567 F. App’x 906, 913 (Fed. Cir. 2014) (“‘where the
general conditions of a claim are disclosed in prior art,’ as here, ‘it is not inventive to
discover the optimum range by routine experimentation.”) (citing In re Aller, 42 C.C.P.A.
824, 220 F.2d 454, 456 (1955)), Ethicon argues that this is impermissible hindsight. The
Federal Circuit has found that “the inventor’s own path itself never leads to a conclusion
of obviousness; that is hindsight. What matters is the path that the person of ordinary
skill in the art would have followed, as evidenced by the pertinent prior art.” Millennium
Pharms., Inc. v. Sandoz Inc., 862 F.3d 1356, 1367 (Fed. Cir. 2017). Ethicon cites the

32

testimony of the ‘055 Patent inventor to support its claim that there was no reasonable
expectation of success in increasing the clamping force of the prior art devices in order to
arrive at the claimed invention. (Houser Tr. at 59:3–20, 702:16–704:21, 724:14-726:25).
Covidien has not shown by clear and convincing evidence that the higher clamping
pressure range did not produce unexpected results.
Finally, even if Covidien has established a prima facie case of obviousness of the
‘055 Patent, the objective evidence indicates that there are genuine disputes of material
fact related to obviousness. Ethicon points to several objective indicia of nonobviousness that preclude invalidating the ‘055 Patent as obvious, including the
commercial success of Ethicon’s ultrasonic devices and praise within the industry.
Ethicon highlights that its Harmonic ACE, an ultrasonic surgical device that embodies
the claimed invention, was recognized by the Ultrasonic Industry Association as the Best
New Ultrasound Product for 2005. (ESUF ¶¶ 231, 410). See Apple Inc., 839 F.3d at
1053 (“Evidence that the industry praised a claimed invention or a product that embodies
the patent claims weighs against an assertion that the same claimed invention would have
been obvious. Industry participants, especially competitors, are not likely to praise an
obvious advance over the known art. Thus, if there is evidence of industry praise of the
claimed invention in the record, it weighs in favor of the non-obviousness of the claimed
invention”). Although Ethicon’s reply brief presents issues of whether the publication
that praised Ethicon’s device represents an independent, third-party analysis (Doc. 208 at

33

12), that is an issue of disputed fact.
The Court finds that Covidien has failed to show obviousness of the ‘055 Patent
by the clear and convincing evidence required to overcome the presumption of validity.
Therefore, Covidien’s motion for summary judgment on the grounds that the ‘055 Patent
is invalid for obviousness is DENIED.
V.

NON-INFRINGING ALTERNATIVES ANALYSIS (Docs. 184, 192)

Having found that Covidien’s Sonicision device infringes on claims 9, 10, and 20–
25 of Ethicon’s ‘055 Patent, the Court now turns to the parties’ motions relating to
damages. Ethicon moves for summary judgment on absence of acceptable and available
non-infringing alternatives. (Doc. 184). Covidien, on the other hand, moves for partial
summary judgment precluding lost profit damages because it contends that noninfringing alternatives were available. (Doc. 192).
Upon proof of infringement, 35 U.S.C. § 284 provides that a “court shall award
[the patent owner] damages adequate to compensate for the infringement but in no event
less than a reasonable royalty for the use made of the invention by the infringer.” The
phrase “damages adequate to compensate” means “full compensation for ‘any damages’
[the patent owner] suffered as a result of the infringement.” General Motors Corp. v.
Devex Corp., 461 U.S. 648, 657 (1983); Grain Processing Corp. v. American Maize–
Prods., 185 F.3d 1341, 1349 (Fed. Cir. 1999). Damage awards fall within two general
categories, to wit: (1) actual damages, e.g., lost profits, and (2) when actual damages

34

cannot be established, a reasonable royalty. An award of damages may be split among
both categories if necessary to compensate the patent owner fully. See State Indus., Inc.
v. Mor–Flo Indus., Inc., 883 F.2d 1573, 1577 (Fed. Cir. 1989).
To establish entitlement to lost profits, “the patent owner has an initial burden to
show a reasonable probability that he would have made the asserted sales ‘but for’ the
infringement.” Grain Processing, 185 F.3d at 1349. To meet this burden, a patent owner
generally must prove four factors set forth in Panduit Corp. v. Stahlin Bros. Fibre Works,
Inc., 575 F.2d 1152 (6th Cir. 1978): (1) demand for the patented products; (2) absence of
acceptable non-infringing alternatives; (3) manufacturing and marketing capability to
exploit the demand; and (4) the amount of the profit it would have made. Id. at 1156.
Here, Ethicon’s motion does not seek summary judgment with respect to lost
profits generally, but instead seeks summary judgment on the second Panduit factor,
contending that Covidien’s alleged non-infringing alternatives were neither acceptable
nor available. Covidien’s motion also focuses on the second Panduit factor, contending
that Ethicon is not entitled to recover lost profits damages because acceptable noninfringing alternatives were available.
“[A] noninfringing alternative need not be on the market during the infringement
period to factor into a lost profits analysis.” Wechsler v. Macke Intern. Trade, Inc., 486
F.3d 1286, 1298 (Fed. Cir. 2007). However, where an alleged non-infringing
alternative was not on the market during the relevant time period, “a trial court may

35

reasonably infer that it was not available as a non-infringing substitute at that time. The
accused infringer then has the burden to overcome this inference by showing that the
substitute was available.” Grain Processing, 185 F.3d at 1353 (citation omitted).
Moreover, “[t]he acceptable substitute element, though it is to be considered, must be
viewed with limited influence where infringer knowingly made and sold the patented
product for years while ignoring the substitute.” Panduit, 575 F.2d at 1162, n,9.,
Covidien does not dispute that its alleged non-infringing alternatives were not on
the market during the relevant time period. Therefore, Covidien bears the burden to
overcome the inference of non-availability. See Grain Processing, 185 F.3d at 1353.
Having “the necessary equipment, know-how, and experience” to make an
alternative product during the relevant time may render the product “available.” Id. at
1354–55. However, the “high cost of a necessary material” or a “finding that an infringer
had to design or invent around the patented technology to develop an alleged substitute
weighs against a finding of availability.” Micro Chem., Inc. v. Lextron, Inc., 318 F.3d
1119, 1123 (Fed. Cir. 2003). “‘Mere speculation or conclusory assertions will not suffice
to overcome the inference’ that posited non-infringing alternatives that were not on the
market nevertheless were available during the relevant period of alleged infringement.”
EMC Corp. v. Pure Storage, Inc., 154 F. Supp. 3d 81, 117 (quoting Grain Processing,
185 F.3d at 1353). “[T]he trial court must proceed with caution in assessing proof of the
availability of substitutes not actually sold during the period of infringement.” Grain

36

Processing, 185 F. 3d at 1353.
Here, Covidien contends that at least two non-infringing alternatives to its
infringing Sonicision device were available during the relevant time period: (1) a device
that shortens the coil spring to apply pressures outside of the 120 to 210 psi claimed
range (“shortening the force spring”); and (2) a device that replaces the coil spring with a
rigid member (“replacing the spring”). (Doc. 193 at 19).
While both parties have raised issues of material fact in dispute regarding the
acceptability of the posited non-infringing alternatives,6 the Court finds on the material,
undisputed facts that Covidien has failed to meet its burden to overcome the inference of
non-availability.
Covidien correctly relies on Grain Processing for the notion that an alternative
device need not be on the market to be available as long as the infringer has the necessary
equipment, know-how, and experience to make the alternative product at the time of the
infringement. In Grain Processing, however, a device was found to be available when “it
took only two weeks to perfect [the alternative] and begin mass producing” the product.
Grain Processing, 185 F.3d at 1346. Yet in Micro Chem, the Federal Circuit found that a
device was not available at the time of infringement when it took over four months to
convert infringing devices into non-infringing devices. Micro Chem., 318 F.3d at 1123.

For example, the Court finds that facts in the record are in dispute over whether Covidien’s
proposed alternative devices would be acceptable to consumers and comparable to the Sonicision
devices on the market, and whether clamping pressures outside the ‘055 Patent range are as
effective. (Doc. 193 at 17–20; Doc. 184 at 19–21).
6

37

The Federal Circuit held that an alleged non-infringing alternative is unavailable where
the record shows that the infringer “designed around the patented technology” after
infringement was established. Id.
The record in this case clearly shows that it would take between 46 and 62 weeks.
(EDSUF at ¶ 28). Regarding the amount of time, cost, and work that would be required
to design around the ‘055 Patent, Covidien’s expert Dr. Keith Ugone stated:
Based upon a discussion with Covidien personnel, Covidien could
have designed around the ‘055 Patent at a modest cost and within a
reasonable time period.
a. Changing the force spring. According to Mr. Jason Craig,
Covidien would need 12 weeks to design and build three to four
proto-type molds and test the tooling. This process would
require an estimated $105,000 in labor and $5,000 in tools and
materials expenses. After the testing, Covidien would need about
34 weeks to build additional tooling for large scale production;
test, validate, and qualify the tooling; and file and obtain the
appropriate approvals from a corresponding 510K submission.
This implementation step would cost $280,000. In total, it would
have taken Covidien an estimated 46 weeks and $390,000 to
design around the ‘055 Patent using this design.
b. Replacing the spring. Covidien could replace the spring with a
rigid member. Covidien would need 24 weeks to design and
build three to four proto-type molds and test the tooling. This
process would require an estimated $250,000 (i.e., $40,000 in
tools and materials expenses and $210,000 in labor costs). After
the testing, Covidien would need about 38 weeks to build
additional tooling for large scale production; test, validate, and
qualify the tooling; and file and obtain the appropriate approvals
from a corresponding 510K submission. This implementation
step would cost $425,000 (i.e., $100,000 for tools and materials
and $325,000 for manpower). In total, it would have taken

38

Covidien an estimated 62 weeks and $675,000 to design around
the ‘055 Patent using this design.
(Doc. 184-10 at ¶ 120).
Thus, it is undisputed, based on Covidien’s own estimates, that it would have
taken over 10 months to design around the ‘055 patent—well over twice the time
required to produce an alternative (which was deemed unavailable) in Micro Chem. The
Court finds that this clearly shows that Covidien’s posited non-infringing alternatives
were unavailable at the time of infringement. Covidien has not come close to overcome
the inference of non-availability, therefore the alleged non-infringing alternative devices
were not available as a matter of law.
Accordingly, Ethicon’s motion for summary judgment of absence of acceptable
and available non-infringing alternatives (Doc. 184) is GRANTED and Covidien’s
motion for summary judgment precluding lost profits damages (Doc. 192) is DENIED.
VI.

CONCLUSION

Accordingly, for the foregoing reasons:
1) Ethicon’s motion for summary judgment of infringement of claims 9, 10,
and 20–25 (Doc. 186) is GRANTED.
2) Covidien’s motion for summary judgment (Doc.188) is GRANTED in
part and DENIED in part as follows:
a. Covidien’s motion for summary judgment of invalidity is DENIED;
b. Covidien’s motion for summary judgment of noninfringement of claims
1, 2, 4, 5, 8, and 14 of the ‘055 Patent is GRANTED;

39

c. Covidien’s motion for summary judgment of noninfringement of all
other claims is DENIED.
3) Ethicon’s motion for summary judgment of absence of acceptable and
available non-infringing alternatives (Doc. 184) is GRANTED.
4) Covidien’s motion for summary judgment precluding lost profits damages
(Doc. 192) is DENIED.
IT IS SO ORDERED.
Date:

5/16/19

Timothy S. Black
United States District Judge

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