Retractable Techs. v. Becton, Dickinson and Co.

United States Court of Appeals
for the Federal Circuit
__________________________

RETRACTABLE TECHNOLOGIES, INC. AND
THOMAS J. SHAW,
Plaintiffs-Appellees,
v.
BECTON, DICKINSON AND COMPANY,
Defendant-Appellant.
__________________________

2010-1402
__________________________

Appeal from the United States District Court for the
Eastern District of Texas in Case No. 07-CV-0250, Chief
Judge David J. Folsom.
____________________________

Decided: July 8, 2011
____________________________

ROY W. HARDIN, Lock, Lord, Bissell & Liddell, LLP, of
Dallas, Texas, argued for plaintiffs-appellees. With him
on the brief were CYNTHIA KEELY TIMMS and MARK R.
BACKOFEN.

WILLIAM F. LEE, Wilmer, Cutler, Pickering, Hale, and
Dorr, LLP, of Boston, Massachusetts, argued for defen-
dant-appellant. With him on the brief were LISA J.
PIROZZOLO; and WILLIAM G. MCELWAIN and HEATH A.
BROOKS, of Washington, DC.
RETRACTABLE TECH v. BECTON DICKINSON 2

__________________________

Before RADER, Chief Judge, and PLAGER and LOURIE,
Circuit Judges.
Opinion for the court filed by Circuit Judge LOURIE.
Concurring opinion filed by Circuit Judge PLAGER. Dis-
senting-in-part opinion filed by Chief Judge RADER.
LOURIE, Circuit Judge.
Becton, Dickinson and Company (“BD”) appeals from
the final judgment of the United States District Court for
the Eastern District of Texas in favor of Thomas J. Shaw
and Retractable Technologies, Inc. (collectively, “RTI”).
See Retractable Techs., Inc. v. Becton, Dickinson & Co.,
No. 2:07-CV-250, Final Judgment and Permanent Injunc-
tion (ECF No. 366) (E.D. Tex. May 19, 2010) (“Final
Judgment”). The judgment follows a trial where a jury
found infringement of certain claims of RTI’s U.S. Patents
5,632,733 (“the ’733 patent”), 6,090,077 (“the ’077 pat-
ent”), and 7,351,224 (“the ’224 patent”). The jury also
found that the asserted patents were not invalid for
anticipation or obviousness. The district court subse-
quently denied BD’s post-trial motions for judgment as a
matter of law (“JMOL”) or for a new trial on the issues of
infringement and invalidity of the asserted patents.
Retractable Techs., Inc. v. Becton, Dickinson & Co., Case.
2:07-CV-250, Order (ECF No. 365) (E.D. Tex. May 19,
2010) (“JMOL Order”).
On appeal, BD challenges the district court’s denial of
its post-trial motions as well as the district court’s claim
constructions, Retractable Techs., Inc. v. Becton, Dickin-
son & Co., Case 2:07-CV-250, Claim Construction Order
(ECF No. 122) (E.D. Tex. Jan. 20, 2009) (“Claim Construc-
tion Opinion”); Retractable Techs., Inc. v. Becton, Dickin-
son & Co., Case 2:07-CV-250, Order (ECF No. 239) (E.D.
3 RETRACTABLE TECH v. BECTON DICKINSON

Tex. Sept. 21, 2009) (“Modified Claim Construction Opin-
ion”), and the district court’s exclusion of RTI’s discovery
responses from evidence, Retractable Techs., Inc. v. Bec-
ton, Dickinson & Co., Case 2:07-CV-250, Order (ECF No.
262) (E.D. Tex. Oct. 8, 2009) (“Motion in Limine Order”);
Retractable Techs., Inc. v. Becton, Dickinson & Co., Case
2:07-CV-250, Order (ECF No. 276) (E.D. Tex. Oct. 28,
2009) (“Motion to Strike Order”). Because the district
court erred in its construction of the claim term “body”
but did not otherwise err, we affirm in part and reverse in
part.
BACKGROUND
This patent infringement case relates to retractable
syringes, which are medical syringes that feature a needle
that retracts into the syringe body after the syringe is
used. The retraction of the needle reduces the risk asso-
ciated with contaminated needles because the used nee-
dle, which resides in the syringe body after retraction, is
less likely to accidently stick a user. RTI and BD both
design and sell retractable syringes.
The parties agree that retractable syringes generally
existed by the early 1990s, and, as an invalidity defense
at trial, BD relied on prior art retractable syringe patents
filed in 1990 and 1991, specifically U.S. Patent 5,053,010
(“McGary”) and U.S. Patent 5,211,629 (“Pressly”). Fig-
ures 1 and 2 of McGary, reproduced below, generally show
how a retractable syringe operates, with Figure 1 depict-
ing a syringe prior to retraction of the needle (labeled 30)
and Figure 2 depicting the syringe after retraction:
RETRACTABLE TECH v. BECTON DICKINSON 4

As disclosed in McGary, prior to retraction, the front
end of the syringe contains a compressed spring (labeled
24) that is pushed against a retainer (labeled 32).
McGary, col.5 l.6–18. The plunger contains a cutting tip
(labeled 42), and after the plunger is fully extended into
the syringe barrel, additional force on the plunger causes
the cutting tip to penetrate through the retainer, which
allows the spring to decompress and retract the needle
into the syringe body. Id. col.5 ll.50–61.
In 1995, Thomas Shaw filed a patent application for a
“Tamperproof Retractable Syringe.” Shaw subsequently
filed a series of continuation and continuation-in-part
applications from the parent application, and these appli-
cations issued as the ’733, ’077, and ’224 patents. The
patents contain a detailed structural disclosure of a
particular retractable syringe assembly. See Claim
Construction Opinion, at 2–3. While multiple claims are
at issue on appeal, claim 43 of the ’224 patent, reproduced
below, is generally representative of the asserted claims,
reciting a syringe assembly that contains a “body” and a
5 RETRACTABLE TECH v. BECTON DICKINSON

“retraction mechanism” in the front end portion of the
“body,” where the “retraction mechanism” contains a
“needle holder” and a “retainer member” that surrounds
the inner head of the “needle holder”:
43. A syringe assembly having a retractable nee-
dle that is rendered unusable after a single
injection of fluid into a patient, the assembly
comprising:
a hollow syringe body comprising a barrel and
having a front end portion and a back end
portion, the back end portion further com-
prising at least one radially extending mem-
ber providing finger grips for the syringe
body;
a retraction mechanism disposed in the front end
portion, the retraction mechanism further
comprising a needle holder having a head
portion, an elongated needle holding portion,
and a longitudinally extending fluid pas-
sageway through the head portion and the
elongated needle holding portion, the head
portion further comprising an inner head, a
continuous retainer member surrounding the
inner head, and a bridging portion disposed
between the continuous retainer member and
the inner head, wherein said bridging portion
couples the continuous retainer member and
the inner head to form a fluid seal between
the fluid passageway and the barrel prior to
retraction, and a compressed retraction
spring surrounding at least part of the elon-
gated needle holding portion and biasing the
inner head toward the back end portion prior
to retraction;
RETRACTABLE TECH v. BECTON DICKINSON 6

a retractable needle extending into the front end
portion of the body through an opening in the
front end portion of the body, the retractable
needle being held in fixed relation to the
elongated needle holding portion of the nee-
dle holder and in fluid communication with
the longitudinally extending fluid passage-
way through the head portion and the needle
holding portion;
a plunger reciprocally disposed inside the barrel
and forming a variable chamber between the
plunger and the needle holder prior to and
during injection, the plunger being receivable
into the barrel through the back end portion
of the body and comprising an outer wall, a
retraction cavity disposed inwardly of the
outer wall, a plunger seal element providing
sliding, sealed engagement between the
plunger and the barrel and preventing fluid
leakage between the plunger and the barrel,
the plunger seal element being restrained
from sliding longitudinally along the outer
wall of the plunger, and a back end with an
end cap having an outer periphery; and
a barrier disposed in the front end portion of the
body that limits forward motion of the needle
holding portion and the retractable needle
relative to the body as the plunger is de-
pressed inside the barrel during injection and
retraction;
wherein the continuous retainer member is re-
leasable from the inner head of the needle
holder when the plunger is further depressed
inside the barrel following injection.
7 RETRACTABLE TECH v. BECTON DICKINSON

’224 patent, col.22 l.35–col.23 l.19 (emphases added).
Generally, the retraction mechanism contains a needle
holder and spring combination. ’733 patent, col.2 l.58–
col.3 l.7. 1 The needle holder contains a circular head, and
a clamping or frictional force on the head holds the needle
holder in position. Id. col.3 l.7–24. When the plunger is
depressed to a “retraction position,” this force causes the
retraction mechanism to activate and release the needle
holder. Id.
Important for the purposes of this appeal, the patents
disclose what RTI refers to as the “bridge” embodiment.
In this embodiment, the head of the needle holder con-
tains two parts, an inner head and a retainer member
that surrounds the inner head. Id. col.3 l.25–46. The
retainer member and the inner head of the needle holder
are connected by a weld that creates a bridge portion. Id.
col. 3 ll.39–46, col.9 ll.7–17. Figure 8, reproduced below,
depicts the “bridge” embodiment, with the inner head of
the needle holder (labeled 72a) connected to the retainer
member (labeled 66a) by a “bridge” that is created by
welding the raised portion of the inner head (labeled 73)
to the retainer member:

1 Because the ’077, ’733, and ’224 patents contain a
common disclosure for the issues presented in this appeal,
we will cite the ’733 patent for simplicity.
RETRACTABLE TECH v. BECTON DICKINSON 8

In this embodiment, when the plunger is fully ex-
tended into the barrel, additional force on the plunger
causes the bridging portion to be “ruptured, fractured or
otherwise separated” so the weld no longer holds the
needle holder in place. Id. col.8 ll.18–56. This allows the
compressed spring (labeled 24) to expand and thereby
retract the needle (labeled 28) and the needle holder
(labeled 22a). Id.
In 2007, RTI sued BD in the Eastern District of
Texas, alleging that BD’s 1 mL and 3 mL IntegraTM
syringes infringe various claims of the ’733, ’077, and ’224
patents. Excluding the plunger, the 3 mL syringe con-
tains two pieces, a syringe body and a needle assembly
that screws into the body. The needle assembly contains
an inner hub and an outer hub that are connected to each
other. The outer hub contains the threads that screw into
the syringe body. The inner hub contains the needle and
a spring compressed against the surface of the inner hub.
9 RETRACTABLE TECH v. BECTON DICKINSON

The plunger in the 3 mL Integra contains a cutter.
When the needle assembly is screwed in and the plunger
is fully extended in the barrel, additional force on the
plunger causes the cutter to cut a portion of the inner hub
of the needle assembly, allowing the spring to expand and
retract the needle into the syringe body.
The 1 mL Integra operates in a similar manner. In
addition to the plunger, the 1 mL Integra contains a one-
piece syringe that includes the needle assembly. Instead
of a cutter located at the end of the plunger, the cutter in
the 1 mL syringe is located within the needle assembly.
The 1 mL Integra syringe retracts the needle when the
plunger applies pressure on the outer edge of the needle
assembly, causing the cutter to cut a portion of the needle
assembly, which allows the spring to expand and retract
the needle.
In the course of the litigation, the district court con-
strued the claims and denied the parties’ dispositive
motions. The court construed the term “retainer member”
as “a non-retractable part of the retraction mechanism
that uses some clamping or frictional force to keep the
needle in the projecting position until that clamping or
frictional force is released.” Claim Construction Opinion,
at 14–16; Modified Claim Construction Opinion, at 6–7.
The district court also concluded that the claimed “re-
tainer member” and “needle holder” need not be two
separate parts. Claim Construction Opinion, at 14. The
district court construed “body” as “a hollow outer struc-
ture that houses the syringe’s components,” and con-
cluded that the term “body” was not limited to a one-piece
structure. Id. at 6–7. Finally, the district court concluded
that the patents did not disclaim the use of “cutting,”
Modified Claim Construction Order, at 8, and concluded
that whether the accused devices’ use of “cutting” fell
RETRACTABLE TECH v. BECTON DICKINSON 10

within the scope of the claims was a question of fact, not a
matter of claim construction, Motion to Strike Order, at 8.
Prior to trial, the district court concluded that it
would exclude from evidence RTI’s discovery responses.
Id. at 7. In particular, RTI refused to produce the results
of a test that detailed the force required to activate retrac-
tion in a retractable syringe made by a third-party that
RTI sued in 2002. Id. at 2. In its response, RTI stated
that “[a]s there presently is no allegation that the infring-
ing products in this case operate by the release of a fric-
tional holding mechanism, the requested document is
irrelevant and not likely to lead to the discovery of admis-
sible evidence.” Id. According to BD, RTI reiterated this
position in a letter to the district court. The district court
excluded these documents on the basis that any presenta-
tion of RTI’s discovery responses “would inextricably
raise” RTI’s prior litigation. Id. at 7.
The parties then tried the case to a jury. Before the
district court submitted the case to the jury, BD moved for
JMOL on numerous issues, and the court denied BD’s
motions. See JMOL Order, at 1–2. The jury subsequently
found that BD infringed multiple claims of the asserted
patents and found that BD failed to prove that any of the
asserted claims were invalid. Id. at 2. After trial, BD
moved for JMOL of noninfringement and invalidity. Id.
at 3–5. BD also moved, in the alternative, for a new trial
on infringement and invalidity. Id. The district court
denied BD’s motions, id. at 5–6, and entered judgment
against BD, Final Judgment, at 1–3.
BD timely appealed. We have jurisdiction pursuant
to 28 U.S.C. § 1295(a)(1).
11 RETRACTABLE TECH v. BECTON DICKINSON

DISCUSSION
BD raises numerous issues on appeal. First, BD chal-
lenges the district court’s construction of the terms “re-
tainer member” and “body.” Second, BD challenges the
district court’s conclusion that, as a matter of law, re-
tractable syringes that operate by “cutting” are not ex-
cluded from the scope of the claims of the asserted
patents. Third, BD argues that the jury’s infringement
finding must be set aside because it is not supported by
substantial evidence. Fourth, BD challenges the district
court’s exclusion from evidence of RTI’s discovery re-
sponses and letter to the district court. Finally, BD
argues that claim 25 was anticipated or obvious as a
matter of law. We address each of these issues below.
A. Standards of Review
In reviewing evidentiary rulings and denials of mo-
tions for JMOL, we apply the law of the regional circuit,
in this case, the Fifth Circuit. Finisar Corp. v. DirecTV
Group, Inc., 523 F.3d 1323, 1328 (Fed. Cir. 2008). Under
Fifth Circuit law, we review denials of JMOL de novo.
Cambridge Toxicology Grp., Inc. v. Exnicios, 495 F.3d 169,
179 (5th Cir. 2007). JMOL is appropriate only if the court
finds that a “reasonable jury would not have a legally
sufficient evidentiary basis to find for the party on that
issue.” FED. R. CIV. P. 50(a)(1); see Cambridge Toxicology,
495 F.3d at 179.
The Fifth Circuit reviews a district court’s evidentiary
rulings for abuse of discretion. Jowers v. Lincoln Elec.
Co., 617 F.3d 346, 355 (5th Cir. 2010). Any error in the
admission or exclusion of evidence “should not be the
basis for setting aside the judgment” unless “the substan-
tial rights of the parties were affected.” EEOC v. Man-
ville Sales Corp., 27 F.3d 1089, 1093 (5th Cir. 1994).
Moreover, where the trial judge “has conducted, on the
RETRACTABLE TECH v. BECTON DICKINSON 12

record, a carefully detailed analysis of the evidentiary
issues and the court's own ruling, appellate courts are
chary about finding an abuse of discretion.” Kelly v.
Boeing Petroleum Servs., Inc., 61 F.3d 350, 356 (5th Cir.
1995).
The proper construction of a patent’s claims is an is-
sue of Federal Circuit law, and we review a district court’s
claim construction de novo. Cybor Corp. v. FAS Techs.,
Inc., 138 F.3d 1448, 1454–55 (Fed. Cir. 1998) (en banc).
To ascertain the scope and meaning of the asserted
claims, we look to the words of the claims themselves, the
specification, the prosecution history, and any relevant
extrinsic evidence. Phillips v. AWH Corp., 415 F.3d 1303,
1315–17 (Fed. Cir. 2005) (en banc).
B. Claim Construction
BD challenges the district court’s construction of “re-
tainer member” and “body” as well as the district court’s
conclusion that the asserted claims do not exclude as a
matter of law devices that operate by “cutting.” We
address each of BD’s challenges below.
1. Retainer Member
BD argues that the district court erred when it con-
cluded that the claimed “retainer member” and “needle
holder” limitations need not be two separate parts. BD
argues that the elements must be separate pieces because
the asserted claims list the “retainer member” and “nee-
dle holder” as separate claim limitations and the specifi-
cations only describe a retainer member that is a separate
part from the needle holder. BD argues that connecting
two pieces via a tack weld, as disclosed in the “bridge”
embodiment, is different from forming the elements as a
single piece. To support that argument, BD points to the
prosecution history, where the inventor allegedly repre-
13 RETRACTABLE TECH v. BECTON DICKINSON

sented to the U.S. Patent and Trademark Office (“PTO”)
that the use of a tack weld to connect two pieces does not
result in a one-piece structure.
We disagree. The claims and the specifications indi-
cate that the “needle holder” and “retainer member” need
not be separately molded pieces. Claim 24 of the ’733
patent, for example, claims a “needle holder,” where the
head of the “needle holder” has a “retainer member which
can be separated from the head of the needle holder.”
Similarly, claim 43 of the ’224 patent claims a “needle
holder having a head portion” where the head portion of
the needle holder “further comprises an inner head, a
continuous retainer member surrounding the inner head,
and a bridging portion disposed between the continuous
retainer member and the inner head.” These claims allow
the “needle holder” and “retainer member” to structurally
overlap prior to separation and indicate that the two
limitations need not be separate pieces.
The specifications also indicate that the “needle
holder” and the “retainer member” need not be separately
molded pieces. The specifications state that the retainer
member and the inner head of the needle holder can be
connected by a weld, and retraction occurs when the weld
is “ruptured or separated.” ’733 patent, col.9 ll.7–13
(disclosing a “tack weld”); id. col.10 l.4 (stating that
“[s]onic welding could also be employed”). As part of this
disclosure, the specifications disclose forming a “bridging
portion” that connects the retainer member and the
needle holder head by welding the elements together to
form the bridging portion, and retraction occurs when the
weld at the bridging portion is “ruptured, fractured or
otherwise separated.” Id. col.9 ll.38–41, col.9 ll.51–56.
The specifications further disclose a method to couple
the two structures by “expos[ing] them to a temperature
RETRACTABLE TECH v. BECTON DICKINSON 14

of about 120°C for twenty minutes or so to allow some
diffusion or incipient melting to occur where they touch.”
Id. col.9 l.65–col.10 l.1. This passage suggests that the
needle holder, retainer member, and bridging portion
could be formed as an integral structure in the first
instance. Thus, the specifications and the claims indicate
that the “retainer member” and the “needle holder” need
not be two separate pieces. See Linear Tech. Corp. v. Int’l
Trade Comm’n, 566 F.3d 1049, 1055 (Fed. Cir. 2009)
(declining to construe “second circuit” and “third circuit”
to require “entirely separate and distinct circuits” where
“nothing in the claim language or specification” supported
that construction and the specification disclosed that the
circuits could share common circuit elements).
The prosecution history does not compel a contrary
result. During prosecution of the application that issued
as the ’224 patent, the inventor argued, among other
things, that the outer wall of the needle assembly dis-
closed in Pressly was not part of a syringe “made of” a
one-piece barrel because the outer wall was fixed to the
barrel “by ultrasonic welding means or other permanent
attachment means following the installation of the retrac-
tion components as described in relation to FIGS. 11–13
[of Pressly].” July 17, 2000 Response and Amendment in
Application Serial Number 09/617,868, at 43 (internal
citations omitted).
This statement by itself, however, is not sufficient to
detract from the claim language and the written disclo-
sure. The inventor’s arguments relate to whether a
“barrel” is “made of” one piece. The arguments do not
address whether the needle assembly and retainer mem-
ber, which are different syringe components that serve
different purposes, can cover distinct structural portions
of an integral structure. In addition, the asserted claims
lack language that limits the needle holder or the retainer
15 RETRACTABLE TECH v. BECTON DICKINSON

member to elements that are “made of” one piece. Ulti-
mately, the inventor’s statement, on its own, lacks the
clarity required to exclude from the scope of the claims a
needle holder and a retainer member that form distinct
portions of a single structure. See Lazare Kaplan Int’l,
Inc. v. Photoscribe Techs., Inc., 628 F.3d 1359, 1369–70
(Fed. Cir. 2010); Phillips, 415 F.3d at 1317. Accordingly,
the district court did not err in its construction of “re-
tainer member.”
2. Body
BD argues that the district court erred when it con-
cluded that the claimed “body” is not limited to a one-
piece structure. BD argues that the specifications de-
scribe “the invention” as including a one-piece body while
criticizing prior art syringes that contain a two-piece
body. BD also argues that claim differentiation does not
apply in light of the written description’s limiting state-
ments.
RTI responds that the ordinary meaning of the term
“body” is not limited to a one-piece body. RTI points to
the different usage of the term “body” in the claims, where
some claims recite a “body” and other claims recite a “one
piece body.” RTI also argues that while the preferred
embodiments disclose a syringe with a one-piece body,
that disclosure is directed to manufacturing benefits, not
the other patentable aspects of the invention.
We agree with BD that the claimed “body” is limited
to a one-piece structure in light of the specifications.
While the patents contain an independent claim that
recites a “body,” ’224 Patent, claim 25, with a dependent
claim that limits the “body” to a “one-piece body,” ’224
Patent, claim 31, none of the claims expressly recite a
body that contains multiple pieces. Thus, while the
RETRACTABLE TECH v. BECTON DICKINSON 16

claims can be read to imply that a “body” is not limited to
a one-piece structure, that implication is not a strong one.
It is axiomatic that the claim construction process en-
tails more than viewing the claim language in isolation.
Claim language must always be read in view of the writ-
ten description, Phillips, 415 F.3d at 1315, and any pre-
sumption created by the doctrine of claim differentiation
“will be overcome by a contrary construction dictated by
the written description or prosecution history,” Seachange
Int’l, Inc. v. C-COR, Inc., 413 F.3d 1361, 1369 (Fed. Cir.
2005). Thus, it is necessary to review the specifications to
determine if the proper construction of the term “body” is
limited to a one-piece body.
The specifications indicate that the claimed “body” re-
fers to a one-piece body. In distinguishing prior art
syringes comprised of multiple pieces, the specifications
state that the prior art had failed to recognize a retract-
able syringe that “can be molded as one piece outer body.”
’733 patent, col.2 ll.26–31. Consistent with this charac-
terization of the prior art, the Summary of the Invention
states that “[t]he invention is a retractable tamperproof
syringe,” and that this syringe “features a one piece
hollow body.” Id. col.2 ll.45–47.
Similarly, the specifications, in describing the inven-
tion, expressly state that each syringe embodiment con-
tains a one-piece body. Id. col.5 l.54–56 (describing a first
syringe embodiment that “has a one piece hollow outer
body”); id. col.10 l.8–9 (disclosing an “alternate syringe”
that has “a one piece hollow outer syringe body”). In
addition, each figure that depicts a syringe body shows a
one-piece body. In contrast, the specifications do not
disclose a body that consists of multiple pieces or indicate
that the body is anything other than a one-piece body.
17 RETRACTABLE TECH v. BECTON DICKINSON

There is a fine line between construing the claims in
light of the specification and improperly importing a
limitation from the specification into the claims. See
Phillips, 415 F.3d at 1323. In reviewing the intrinsic
record to construe the claims, we strive to capture the
scope of the actual invention, rather than strictly limit the
scope of claims to disclosed embodiments or allow the
claim language to become divorced from what the specifi-
cation conveys is the invention. Id. at 1323–24.
In this case, while the claims leave open the possibil-
ity that the recited “body” may encompass a syringe body
composed of more than one piece, the specifications tell us
otherwise. They expressly recite that “the invention” has
a body constructed as a single structure, expressly distin-
guish the invention from the prior art based on this
feature, and only disclose embodiments that are expressly
limited to having a body that is a single piece. Thus, a
construction of “body” that limits the term to a one-piece
body is required to tether the claims to what the specifica-
tions indicate the inventor actually invented. Accord-
ingly, the district court erred when it construed “body” as
encompassing bodies composed of multiple pieces.
3. Exclusion of Devices that Operate by “Cutting”
BD also appeals the district court’s conclusion that
the asserted claims, as a matter of law, do not exclude
retractable syringes that operate by “cutting.” As an
initial matter, RTI argues that BD waived this claim
construction argument because BD first raised the argu-
ment on appeal.
We disagree. On at least two occasions, BD presented
this argument in substance to the district court. See
Claim Construction Opinion, at 14; Modified Claim
Construction Opinion, at 8. Thus, BD’s argument is
properly before this court. See Interactive Gift Express,
RETRACTABLE TECH v. BECTON DICKINSON 18

Inc. v. Compuserve, Inc., 256 F.3d 1323, 1346–47 (Fed.
Cir. 2001).
Turning to the merits, BD argues that the specifica-
tions expressly criticize and distinguish prior art devices
that operate by methods other than friction. BD asserts
that these statements disclaim devices that operate by
“cutting,” and the claims should be construed accordingly.
We disagree. Nothing in the claim language indicates
that the claims exclude “cutting” as a matter of law. To
disavow claim scope, the specification must contain “ex-
pressions of manifest exclusion or restriction, represent-
ing a clear disavowal of claim scope.” Epistar Corp. v.
Int’l Trade Comm’n, 566 F.3d 1321, 1335 (Fed. Cir. 2009).
In general, statements about the difficulties and failures
in the prior art, without more, do not act to disclaim claim
scope. See Spine Solutions, Inc. v. Medtronic Sofamor
Danek USA, Inc., 620 F.3d 1305, 1315 (Fed. Cir. 2010)
(concluding that statement that a prior art two-piece
implant was “particularly difficult” to achieve did not
disclaim two-piece implants).
As described above, the specifications disclose a
“bridge” embodiment where the retainer member and
needle holder are welded together and connected by a
bridge. ’733 patent, col.9 ll.7–56. In this embodiment, the
needle retracts when the weld at the bridge portion is
“ruptured, fractured or otherwise separated,” allowing the
spring force to cause the needle to retract into the syringe
body. Id. col. 9 ll.51–56. Broadly, this disclosure indi-
cates that at least some forms of “cutting” fall within the
scope of the invention.
In addition to including the bridge embodiment, the
specifications do not clearly exclude “cutting” from the
scope of the claims. The specifications note that a prob-
lem with prior art retractable syringes is their “depend-
19 RETRACTABLE TECH v. BECTON DICKINSON

ence on flexing or breaking of internal parts by the
plunger in order to release the retraction mechanism and
use of a diaphragm at the end of the plunger which must
be penetrated by a needle holding member and spring.”
Id. col.1 ll.48–52. The background section also notes that
“[t]he prior art has not recognized a retraction mechanism
with separable parts that relies entirely on clamping force
or friction . . . .” Id. col.2 ll.18–26. Ultimately, these
statements discuss particular problems with the prior art,
and absent from these statements is a manifest exclusion
of all “cutting” from the scope of the claims. Thus, we
conclude that the district court did not err in concluding
that the asserted patents, as a matter of law, do not
disclaim devices that operate by “cutting.”
C. Infringement
BD appeals the district court’s denial of BD’s motion
for JMOL that the accused 3 mL and 1 mL Integra sy-
ringes do not infringe the asserted patents. We address
each accused syringe in turn.
1. 3 mL Integra
BD raises numerous arguments on appeal as to why
the jury’s verdict of infringement was not supported by
substantial evidence. Because we conclude that no rea-
sonable jury could find that the 3 mL Integra meets the
“body” limitation, as revised herein, literally or under the
doctrine of equivalents, we decline to address BD’s re-
maining arguments.
It is undisputed that under a construction that limits
the “body” to a one-piece structure, the 3 mL Integra does
not literally infringe any of the asserted claims. The issue
that remains is whether RTI may pursue an infringement
theory based on the doctrine of equivalents. BD argues
that because the specifications criticize prior art syringes
RETRACTABLE TECH v. BECTON DICKINSON 20

that contain multiple bodies, RTI is precluded from as-
serting infringement under the doctrine of equivalents.
RTI argues that it is entitled to litigate on remand the
fact issue of whether the 3 mL Integra infringes under the
doctrine of equivalents.
We agree with BD. While infringement under the
doctrine of equivalents is a question of fact, Graver Tank
& Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 609–10
(1950), whether statements in the specification limit the
scope of equivalents is a question of law, J & M Corp. v.
Harley-Davidson, Inc., 269 F.3d 1360, 1366 (Fed. Cir.
2001). It is well settled that “when a specification ex-
cludes certain prior art alternatives from the literal scope
of the claims and criticizes those prior art alternatives,
the patentee cannot then use the doctrine of equivalents
to capture those alternatives.” L.B. Plastics, Inc. v.
Amerimax Home Prods., Inc., 499 F.3d 1303, 1309 (Fed.
Cir. 2007) (collecting cases).
Here, statements in the specifications preclude RTI
from asserting that a body constructed of two pieces
infringes the asserted claims under the doctrine of equiva-
lents. As described above, the specifications expressly
recite that “the invention” has a body constructed as a
single piece and expressly distinguish the invention from
the prior art based on this feature. With these distin-
guishing statements in the specifications, RTI cannot use
the doctrine of equivalents to claim subject matter that
the specifications expressly state fall outside the inven-
tion. Accordingly, we reverse the district court’s denial of
BD’s motion for JMOL and render judgment that the 3
mL Integra syringes do not infringe any of the asserted
claims as a matter of law.
21 RETRACTABLE TECH v. BECTON DICKINSON

2. 1 mL Integra
BD argues that the 1 mL Integra does not, as a mat-
ter of law, infringe the asserted claims under BD’s con-
struction of “retainer member” and under BD’s argument
that the patents exclude “cutting” from the scope of the
claims. Having rejected these arguments, we affirm the
district court’s denial of JMOL of noninfringement for the
1 mL Integra syringes.
D. Exclusion of RTI’s Discovery Responses and Letter to
the District Court
BD also appeals the district court’s denial of BD’s mo-
tion for a new trial on infringement based on the district
court’s exclusion from evidence of RTI’s discovery re-
sponses and letter to the district court. BD argues that
the district court abused its discretion by erroneously
applying the balancing test in Federal Rule of Evidence
403. BD asserts that the exclusion of these documents
affected its substantial rights because the documents
would have exposed RTI’s contradictory infringement
positions and constituted evidence that BD could have
used to impeach RTI’s expert at trial.
We disagree. The district court, in granting BD’s mo-
tion in limine, excluded from evidence references to RTI’s
prior patent litigation pursuant to Federal Rules of Evi-
dence 403, 404, and 408. Motion in Limine Order, at 3.
Subsequently, the district court assessed RTI’s discovery
responses and concluded that allowing BD to introduce
the document would inevitably raise the previously-
excluded issue of RTI’s prior litigation. Motion to Strike
Order, at 7. This conclusion was not arbitrary or clearly
erroneous because RTI’s statements were in response to
BD’s request that RTI produce documents related to RTI’s
prior litigation against a third party. Thus, we conclude
that the district court did not abuse its discretion by
RETRACTABLE TECH v. BECTON DICKINSON 22

excluding RTI’s discovery responses and RTI’s letter to
the district court regarding those responses. Accordingly,
we affirm the district court’s denial of BD’s motion for a
new trial on the issue of infringement.
E. Invalidity of Claim 25 of the ‘077 Patent
Finally, BD argues that the district court erred when
it denied BD’s motion for JMOL that claim 25 of the ‘077
patent was anticipated by McGary or Pressly or rendered
obvious in light of these references in view of UK Patent
Application GB 2197792A (“Power”). As an initial matter,
RTI argues that BD waived these invalidity arguments by
failing to advance the arguments in a pre-verdict motion
for JMOL. See FED. R. CIV. P. 50(a). We disagree.
Rule 50(a)(2) requires the moving party, before the
case is submitted to the jury, to “specify the judgment
sought and the law and the facts that entitle the movant
to the judgment.” The Fifth Circuit has construed this
rule liberally, concluding that oral motions that succinctly
state the basis for the motion are sufficient under Rule 50
to preserve the issue. Tharling v. City of Port Lavaca, 329
F.3d 422, 426 n.4 (5th Cir. 2003); see also Blackboard v.
Desire2Learn, Inc., 574 F.3d 1371, 1379–80 (Fed. Cir.
2009) (collecting cases from the Fifth Circuit).
BD’s pre-verdict motion is sufficient under Rule 50.
At the close of the evidence, BD presented an oral motion
to the district court that sought JMOL that claim 25 of
the ‘077 patent was “anticipated by McGary and/or
Pressly and/or obvious in light of the combination of
McGary, Pressly, and Power.” JMOL Order, at 6 n.1. The
motion identified both the legal grounds for the motion as
well as the underlying references for each ground, thus
alerting the district court to and putting RTI on notice of
BD’s specific anticipation and obviousness positions. See
23 RETRACTABLE TECH v. BECTON DICKINSON

id. No more was necessary to satisfy the requirements of
Rule 50(a). See Blackboard, 574 F.3d at 1380.
Because BD did not waive its invalidity arguments,
we address each of BD’s arguments below.
1. Anticipation
BD argues that it is entitled to JMOL that McGary
and/or Pressly anticipate claim 25 of the ’077 patent. The
parties agree that McGary and Pressly each disclose every
limitation of claim 25 with one exception. Claim 25
requires “a plunger having a retraction position obtained
by pressing the thumb cap to move the plunger forward
beyond the tactile first position and thereby operating the
retraction mechanism and simultaneously lodging the
thumb cap in the open back of the barrel thereby render-
ing the thumb cap inaccessible for grasping.” In particu-
lar, the parties dispute whether McGary and Pressly
disclose “lodging the thumb cap in the open back of the
barrel thereby rendering the thumb cap inaccessible from
grasping.”
BD argues that both McGary and Pressly disclose the
“lodging” limitation and points to Figure 13 of McGary
and Figure 2 of Pressly. Reproduced below are the por-
tions of these figures that BD claims depict the open back
of the syringe barrel and the thumb cap lodged into the
open back of the barrel:
RETRACTABLE TECH v. BECTON DICKINSON 24

McGary, Fig. 13 Pressly, Fig. 2

In response, RTI points to testimony by its technical
expert that both McGary and Pressly, which the PTO
considered during prosecution, do not meet the “lodging”
limitation because those references require the end of the
syringe body to be spread apart in order for the thumb
cap to fit in the body and lock the thumb cap in place.
We agree with RTI. For a prior art reference to an-
ticipate a patent claim, the reference, as read by one of
ordinary skill in the art, must disclose each claim limita-
tion. Dayco Prods., Inc. v. Total Containment, Inc., 329
F.3d 1358, 1368–69 (Fed. Cir. 2003). Whether a prior art
reference anticipates a claim is a question of fact that we
review for substantial evidence when the issue is tried to
a jury. Orion IP, LLC v. Hyundai Motor Am., 605 F.3d
967, 974 (Fed. Cir. 2010).
In this case, RTI presented expert testimony that the
McGary and Pressly references disclose “locking” the
thumb cap and that one of ordinary skill in the art would
conclude that this disclosure does not meet the “lodging
25 RETRACTABLE TECH v. BECTON DICKINSON

the thumb cap” limitation. J.A. 2608. While BD pre-
sented contrary expert testimony, the jury was free to
credit or discredit that testimony in rendering a verdict.
In addition, during prosecution of the application that
issued as the ’077 patent, inventor Shaw argued that
Pressly, instead of disclosing a thumb cap that lodges into
the back end of the open barrel, “requires locking of the
plunger in accordance with the conventional wisdom of
the syringe art.” September 28, 1998 Response and
Amendment in Application Serial Number 09/843,050, at
9–11. Thus, substantial evidence supports the jury’s
verdict that Pressly and McGary do not anticipate claim
25 of the ’077 patent.
2. Obviousness
We reach a similar conclusion on BD’s appeal of the
district court’s denial of its motion for JMOL that claim
25 would have been obvious as a matter of law in light of
Pressly and/or McGary in view of Power. BD primarily
relies on Figures 3 and 4 from Power, and reproduced
below are portions of those figures that show the open end
of the barrel and the thumb cap:

Power, Fig. 3 Power, Fig. 4
BD argues that Figure 3 discloses the “lodging” limi-
tation and that Power, by also disclosing a “locking”
embodiment in Figure 4, shows that it would have been
RETRACTABLE TECH v. BECTON DICKINSON 26

obvious to replace the “locking” embodiment in McGary or
Pressly with the “lodging” embodiment in Power.
We disagree. Under the Patent Act, “[a] patent may
not be obtained . . . if the differences between the subject
matter sought to be patented and the prior art are such
that the subject matter as a whole would have been
obvious at the time the invention was made to a person
having ordinary skill in the art to which said subject
matter pertains.” 35 U.S.C. § 103(a). Although the
ultimate determination of obviousness under § 103 is a
question of law, it is based on several underlying factual
findings, including (1) the scope and content of the prior
art; (2) the level of ordinary skill in the pertinent art; (3)
the differences between the claimed invention and the
prior art; and (4) evidence of secondary factors, such as
commercial success, long-felt need, and the failure of
others. Graham v. John Deere Co., 383 U.S. 1, 17–18
(1966). When a party appeals a jury verdict of nonobvi-
ousness, we first review the jury’s underlying factual
findings for substantial evidence. See Duro-Last, Inc. v.
Custom Seal, Inc., 321 F.3d 1098, 1108 (Fed. Cir. 2003).
After conducting this review, we independently review the
district court’s legal conclusion on obviousness. See id.
In this case, substantial evidence supports the jury’s
presumed findings on the factual issues that underlie the
conclusion of nonobviousness. RTI presented expert
testimony that, at the time Shaw filed his parent patent
application in 1995, artisans of ordinary skill would not
have been motivated to replace the “locking” mechanism
disclosed in McGary and Pressly with the “lodging”
mechanism for a conventional syringe disclosed in Power.
J.A. 2608–10. RTI also presented expert testimony,
including testimony regarding BD’s internal studies from
the 1990s on the impracticability of retractable syringes,
that supports the jury’s presumed factual findings related
27 RETRACTABLE TECH v. BECTON DICKINSON

to secondary considerations of nonobviousness. Id. at
2604–10.
Having concluded that substantial evidence supported
the jury’s factual findings, there only remains the ulti-
mate legal conclusion of obviousness. Although the
figures from these references, on their face, tend to show
that Power’s “lodging” mechanism is interchangeable with
the “locking” mechanism disclosed in McGary or Pressly,
we cannot, in light of the jury’s underlying factual deter-
minations, conclude that claim 25 of the ’077 patent
would have been obvious in 1995 to one of ordinary skill
in the art. Thus, we affirm the district court’s denial of
BD’s motion for JMOL that claim 25 of the ’077 patent
was obvious.
CONCLUSION
For the foregoing reasons, we reverse the district
court’s judgment that the 3 mL Integra infringed claims
43, 55, 60, and 61 of the ’224 patent and claim 25 of the
’077 patent, affirm the court’s judgment that the 1 mL
Integra infringes claims 43, 55, and 60 of the ’244 patent
and claims 1 and 24 of the ‘733 patent, and affirm the
district court’s judgment that claim 25 of the ’077 patent
is not invalid for anticipation or obviousness.
REVERSED IN PART AND AFFIRMED IN PART
COSTS
No costs.
 United States Court of Appeals
for the Federal Circuit
__________________________

RETRACTABLE TECHNOLOGIES, INC. AND
THOMAS J. SHAW,
Plaintiffs-Appellees,
v.
BECTON, DICKINSON AND COMPANY,
Defendant-Appellant.
__________________________

2010-1402
__________________________

Appeal from the United States District Court for the
Eastern District of Texas in Case No. 07-CV-0250, Chief
Judge David J. Folsom.
__________________________

PLAGER, Circuit Judge, concurring.
I join the thorough and well-reasoned opinion of
Judge Lourie. I write because, in the welter of all the
claims in this case (both patent and litigation), the multi-
ple patents at issue, the number of issues the parties have
chosen to argue about (including the important claim
construction issue), it would be easy to lose sight of a
fundamental point so well made in the majority opinion:
“In reviewing the intrinsic record to construe the claims,
we strive to capture the scope of the actual invention,
rather than . . . allow the claim language to become di-
vorced from what the specification conveys is the inven-
tion.” Majority Op. at 17. Judge Lourie articulated that
RETRACTABLE TECH v. BECTON DICKINSON 2

idea more fully in his excellent concurring/dissenting
opinion in Arlington Industries, Inc. v. Bridgeport Fit-
tings, Inc, where he said: “[T]he basic mandate is for
claims to be interpreted in light of the specification of
which they are a part because the specification describes
what the inventors invented. The specification is the
heart of the patent. In colloquial terms, ‘you should get
what you disclose.’” 632 F.3d 1246, 1252 (Fed. Cir. 2011)
(citations omitted).
However much desired by the claim drafters, who
want claims that serve as business weapons and litigation
threats (see Arlington Industries at 1248; Enzo Biochem,
Inc. v. Applera Corp., 599 F.3d 1325, 1342 (Fed. Cir.
2010)), the claims cannot go beyond the actual invention
that entitles the inventor to a patent. For that we look to
the written description. 1 See 35 U.S.C. § 112. I have
written elsewhere about the curse of indefinite and am-
biguous claims, divorced from the written description,
that we regularly are asked to construe, and the need for
more stringent rules to control the curse. See Enzo Bio-
chem, Inc. v. Applera Corp., 605 F.3d 1347, 1348-1349
(Fed. Cir. 2010) reh’g denied (Plager, dissenting).
I understand how a perfectly competent trial judge
can be persuaded by the siren song of litigation counsel to
give the jury wide scope regarding what is claimed. But it
is a song to which courts should turn a deaf ear if patents
are to serve the purposes for which they exist, including
the obligation to make full disclosure of what is actually
invented, and to claim that and nothing more.

1 The term “specification” is sometimes used in
briefs and opinions when, depending on the context, the
narrower term “written description” may be appropriate.
See 35 U.S.C. § 112 (“The specification shall contain a
written description of the invention, and . . . shall con-
clude with one or more claims.”).
 United States Court of Appeals
for the Federal Circuit
__________________________

RETRACTABLE TECHNOLOGIES, INC. AND
THOMAS J. SHAW,
Plaintiffs-Appellees,
v.
BECTON, DICKINSON, AND COMPANY,
Defendant-Appellant.
__________________________

2010-1402
__________________________

Appeal from the United States District Court for the
Eastern District of Texas in Case No. 07-CV-0250, Chief
Judge David J. Folsom.
__________________________

RADER, Chief Judge, dissenting in part.
This court construes “body,” as used in the ’224 patent
and the ’077 patent, to require a one-piece structure.
Because the language of the claims make clear that
“body” does not contain such a limitation, and it is im-
proper to import limitations from the specification into
the claims, I respectfully dissent.
I
In Phillips v. AWH Corp., this court recognized as “a
bedrock principle of patent law” that the claims them-
selves, not the written description portion of the specifica-
tion, define the patented invention. 415 F.3d 1303, 1312
RETRACTABLE TECH v. BECTON DICKINSON 2

(Fed. Cir. 2005). Claim language is to be given its ordi-
nary and customary meaning, as understood by a person
of ordinary skill in the art at the time of the invention.
Id. at 1312-13. In this case, neither party contends that
“body” has a special, technical meaning in the field of art,
and thus claim construction requires “little more than the
application of the widely accepted meaning of commonly
understood words.” Id. at 1314. The ordinary and cus-
tomary meaning of “body” does not inherently contain a
one-piece structural limitation. Moreover, neither the
claim language nor the written description evinces intent
by the patentee to limit the scope of “body” to one-piece
bodies.
To the contrary, the language in the claims makes
clear that “body” is not limited to a one-piece structure.
In order for dependent claims 14 and 57 in the ’224 patent
to have claim scope different from independent claims 1
and 43, respectively, “body” cannot be limited to a one-
piece structure. Claim 1 of the ’224 patent claims “[a]
syringe comprising a hollow body” with various additional
limitations. ’224 patent col.18 l.38. Claim 14 claims
“[t]he syringe of claim 1 comprising a one-piece barrel.”
Id. col.19 l.47. Similarly, claim 43 of the ’224 patent
claims a syringe assembly comprising “a hollow syringe
body” and other components, id. col.22 l.38, while claim
57 claims “[t]he syringe assembly of claim 43 wherein the
body comprises a one-piece barrel,” id. col.24 ll.23-24.
Under the doctrine of claim differentiation, “the presence
of a dependent claim that adds a particular limitation
gives rise to a presumption that the limitation in question
is not present in the independent claim.” Phillips, 415
F.3d at 1315. This presumption is “especially strong
when the limitation in dispute is the only meaningful
difference between an independent and dependent claim,
and one party is urging that the limitation in the depend-
3 RETRACTABLE TECH v. BECTON DICKINSON

ent claim should be read into the independent claim.”
SunRace Roots Enter. Co., Ltd. v. SRAM Corp., 336 F.3d
1298, 1303 (Fed. Cir. 2003). That is precisely the situa-
tion in this case. The only difference between independ-
ent claims 1 and 43 and dependent claims 14 and 57,
respectively, is the addition of the “one-piece” limitation
in the dependent claims, and appellants seek to read this
“one-piece” limitation from the dependent claims into the
independent claims. Such a reading would render the
dependent claims completely superfluous.
Certainly, the claims do not stand alone and must be
read in light of the specifications. Phillips, 415 F.3d at
1315. Nothing in the specifications, however, rebuts the
strong presumption created by the claim language that
“body” does not contain a one-piece structural limitation.
The specifications do not reveal a special definition given
by the inventor to the word “body.” Nor do the specifica-
tions contain an intentional disclaimer or disavowal of
claim scope by the inventor.
Although the specifications state that “[o]ne of the
problems of the prior art of retractable syringes is the
sheer number and complexity of parts which must be
formed and assembled,” ’224 patent col.1 ll.55-57, reduc-
ing the number of parts required to make the syringe is
only one of numerous objectives disclosed by the ’224 and
’077 patents. For example, other objectives include creat-
ing a retractable syringe that does not require breaking of
internal parts, is not temperature sensitive, will not
prematurely retract, requires relatively low thumb pres-
sure to activate, has a high blowout pressure, and pre-
vents reuse. See ’244 col.1 l.57-col.3 l.5. “[T]he fact that a
patent asserts that an invention achieves several objec-
tives does not require that each of the claims be construed
as limited to structures that are capable of achieving all of
the objectives.” Phillips, 415 F.3d at 1327 (internal
RETRACTABLE TECH v. BECTON DICKINSON 4

quotations omitted). Accordingly, the fact that a one-
piece body would achieve one of the objectives of the
patented invention does not mean that such a limitation
should be read into every claim. This is particularly true
given the fact that a one-piece barrel is explicitly required
in some of the dependent claims in the ’224 patent.
The fact that the embodiments described in the speci-
fications have one-piece bodies is also an insufficient basis
for construing “body” to have a one-piece structural limi-
tation. It is improper to import limitations from the
specification into the claims, and this court has expressly
and repeatedly warned against confining claims to spe-
cific embodiments of the invention set forth in the specifi-
cation. See Phillips, 415 F.3d at 1323.
While portions of the specifications reference a “one
piece hollow outer body,” see, e.g., ’224 patent col.3 ll.16-
17, these references do not rise to the level of an expres-
sion of manifest exclusion or an express disclaimer of
claim scope. See Gillette Co. v. Energizer Holdings, Inc.,
405 F.3d 1367, 1374 (Fed. Cir. 2005) (“words or expres-
sions of manifest exclusion or explicit disclaimers in the
specification are necessary to disavow claim scope”). In
fact, the inventor’s consistent use of the modifier “one
piece” (or “one-piece”) both in the claims and in the writ-
ten description when he intended to describe a syringe
with a one-piece body strongly implies that “body,” stand-
ing alone, does not inherently contain a one-piece struc-
tural limitation. See Phillips, 415 F.3d at 1314 (use of the
term “steel baffles” “strongly implies that the term ‘baf-
fles’ does not inherently mean objects made of steel”).
When the inventor intended to impose a one-piece struc-
tural limitation, he did so explicitly, as shown by depend-
ent claims 14 and 57 in the ’224 patent. Consequently,
this court should not impose such a structural limitation
on claims that merely use the term “body” without a “one-
5 RETRACTABLE TECH v. BECTON DICKINSON

piece” modifier. Such a construction is contrary to the
ordinary and customary meaning of the word “body,”
violates the doctrine of claim differentiation, and lacks
support in the patents at issue.
II
Based on a construction of “body” that contains a one-
piece limitation, this court reverses the district court’s
denial of BD’s renewed motion for judgment as a matter
of law and finds non-infringement of the asserted claims
as a matter of law. Because I find that “body” does not
contain a one-piece limitation and also find that the trial
record contains substantial evidence supporting the jury’s
finding of infringement, I would affirm the district court’s
judgment that the 3mL Integra infringed claims 43, 55,
60, and 61 of the ’224 patent and claim 25 of the ’077
patent.