United States Court of Appeals
for the Federal Circuit
______________________
ST. JUDE MEDICAL, INC., AND ST. JUDE MEDICAL
PUERTO RICO, LLC,
Plaintiffs-Appellees,
v.
ACCESS CLOSURE, INC.,
Defendant-Appellant.
______________________
2012-1452
______________________
Appeal from the United States District Court for the
Western District of Arkansas in No. 08-CV-4101, Senior
Judge Harry F. Barnes.
______________________
Decided: September 11, 2013
______________________
ANDREI IANCU, Irell & Manella, LLP, of Los Angeles,
California, argued for plaintiffs-appellees. With him on
the brief were MORGAN CHU, ALAN J. HEINRICH, KEITH A.
ORSO, C. MACLAIN WELLS, ERIC B. HANSON and LAURA
EVANS.
JOSEPH R. RE, Knobbe, Martens Olson & Bear, LLP, of
Irvine, California, argued for defendant-appellant. With
him on the brief was TANYA MAZUR. Of counsel on the
brief were CHARLES K. VERHOEVEN, DAVID EISEMAN and
2 ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC.
MATTHEW D. CANNON, Quinn Emanuel Urquhart & Sulli-
van, LLP, of San Francisco, California.
______________________
Before LOURIE, PLAGER, and WALLACH, Circuit Judges.
Opinion for the court filed by Circuit Judge PLAGER.
Concurring opinion filed by Circuit Judge LOURIE.
PLAGER, Circuit Judge.
This is a patent case. Access Closure, Inc. (ACI), the
defendant at trial, appeals from several rulings made by
the United States District Court for the Western District
of Arkansas in favor of St. Jude Medical, Inc. and St. Jude
Medical Puerto Rico, LLC (collectively “St. Jude”), plain-
tiffs patentees. The rulings relate to three patents that
St. Jude asserted against ACI: U.S. Patent No. 7,008,439
to Janzen et al. (the Janzen patent or ’439 patent); and
U.S. Patent No. 5,275,616 to Fowler (the ’616 patent) and
U.S. Patent No. 5,716,375 to Fowler (the ’375 patent)—we
refer to the ’616 and ’375 patents collectively as the
“Fowler patents.”
ACI appeals three of the district court’s rulings: (1)
that the safe-harbor provision of 35 U.S.C. § 121 protects
the Janzen patent from invalidity due to double-
patenting; (2) the construction of key terms in the Janzen
patent; and (3) that ACI was not entitled to JMOL that
the Fowler patents are invalid for obviousness. For the
reasons that follow, we (1) reverse the district court’s safe
harbor ruling regarding the Janzen patent; (2) in light of
our safe harbor ruling, determine that the district court’s
rulings regarding the claim constructions in the Janzen
patent are moot; and (3) affirm the district court’s ruling
that the Fowler patents are nonobvious and not shown to
be invalid.
ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC. 3
I. BACKGROUND
The patents in this appeal relate to methods and de-
vices for sealing a ‘vascular puncture.’ A vascular punc-
ture occurs when a medical procedure requires a medical
professional to puncture through the skin and into a vein
or artery to insert a medical device, such as a catheter,
into a patient’s vasculature. After such a procedure
concludes, the medical professional typically removes the
medical device from the vasculature.
Prior to the development of the technology at issue in
this case, the medical professional was then required to
apply external pressure to the puncture site until clotting
occurred. Due to a variety of factors, the medical profes-
sional often had to apply pressure to the puncture site for
an extended period of time. This caused discomfort to the
patient and increased the recovery time. The Janzen and
Fowler patents disclose a variety of methods and devices
for sealing a vascular puncture with the objective of
improving patient recovery.
A. The Janzen Patent
There are four patents of importance in the Janzen
family. The following chart illustrates the relationship
between these patents.
Grandparent
Patent
Divisional
Parent
Patent
Continuation Continuation
Janzen Sibling
Patent Patent
4 ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC.
The Janzen patent discloses a medical device that in-
serts a plug into a vascular puncture to seal the puncture
and prevent bleeding. Janzen patent, col.2 ll.29–33. The
disclosed device has a sheath and a piston or plug pusher
that pushes a plug through the sheath and ejects it into
the skin at the puncture site. Id. col.5 ll.31–42. The plug
may be composed of collagen or some other material that
can be absorbed by the body. Id. col.2 ll.22–24. Figure 10
of the Janzen patent, reproduced below, depicts a repre-
sentative embodiment of the Janzen device.
The Janzen patent has three claims at issue in this
appeal, dependent claim 7, independent claim 8, and
independent claim 9. Independent claim 8, which is
generally representative, includes “an elongated mem-
ber,” “[a] plug member . . . disposed in said elongated
member,” and “an ejecting mechanism for ejecting said
plug member from [a] distal end of said elongated mem-
ber so as to place said plug member in blocking relation
with said puncture, so as to seal said puncture.” Id.
col.10 l.56 – col.11 l.2.
The Janzen patent is a descendant from U.S. Patent
Application No. 07/746,339, filed on August 16, 1991 (the
grandparent application). In response to the grandparent
application, the examiner issued an Examiner’s Action
ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC. 5
that stated that the claims in the application included at
least two patentably distinct inventions, one drawn to a
device, the other drawn to a method, denominated here as
Groups I and II:
[Group] I. Claims . . . drawn to a device for use in
sealing a puncture in a wall of a blood
vessel.
[Group] II. Claims . . . drawn to a method of seal-
ing a puncture in a wall of a blood ves-
sel.
J.A. 18,557. The Examiner’s Action required restriction of
the application under 35 U.S.C. § 121 to one of the two
inventions/groups. Id.
In addition to the device/method restriction, the ex-
aminer stated that the claims included patentably distinct
Species A, B, and C (as described below), and the Exam-
iner’s Action required that the applicant elect one of these
Species in addition to electing Group I or Group II.1
Species A: Claims relating to the apparatus
comprising a solid tissue dilator;
Species B: Claims relating to the apparatus
comprising a hollow dilator and
guidewire;
Species C: Claims relating to the apparatus
comprising a guidewire and no dilator.
J.A. 18,558. The applicant responded to the restriction
and elected Group I, Species B, that is, the application
would now include only claims relating to a de-
vice/apparatus comprising a dilator and guidewire. The
1 The examiner also required election of subspecies
not at issue in this appeal.
6 ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC.
grandparent application as thus restricted ultimately
issued as U.S. Patent No. 5,391,183, the grandparent
patent.
On October 5, 1994, the applicant filed U.S. Patent
Application No. 08/318,380 (the parent application) as a
“divisional” of the grandparent application. During
examination of the parent application, the examiner again
imposed a restriction requirement and an election of
species that were substantially identical to the re-
strictions imposed on the grandparent application. In
response, the applicant again elected the same group and
species, Group I, Species B.2 The parent application
ultimately issued as U.S. Patent No. 5,830,130, the parent
patent.
Before the parent patent issued, the applicant filed
U.S. Patent Application No. 08/399,535, the Janzen
application, as a continuation of the parent application.
However, in the Janzen application, the applicant can-
celed the original claims and copied both device and
method claims from a different patent to provoke an
interference proceeding. The Janzen application ulti-
mately prevailed in the interference, and issued with both
device and method claims as the ’439 patent, i.e., the
Janzen patent.
The applicant also pursued another continuation
based on the parent application. This sibling to the Jan-
2 ACI contends that the parent application was not
a true divisional since it elected the same invention as the
grandparent. ACI relied on this fact to support one of its
arguments that the Janzen patent does not qualify for
safe harbor protection. Since we hold that the Janzen
patent does not qualify for safe harbor protection on other
grounds (see infra), we need not address this issue.
ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC. 7
zen application ultimately issued as U.S. Patent
5,725,498, the sibling patent or ’498 patent. The sibling
patent issued earlier than the Janzen patent due to the
Janzen patent’s interference proceeding.
B. The Fowler Patents
Like the Janzen patent, the Fowler patents disclose
devices and methods for closing a vascular puncture with
a plug, but the Fowler patents also disclose a balloon
catheter with a balloon configured to position the plug.
’616 patent, col.4 l.46 – col.5 l.6.3 A user inserts the
balloon catheter in the puncture tract until the balloon is
positioned in the vessel, and the user inflates the balloon.
Id. The user then inserts a plug such that the plug con-
tacts the inflated balloon; the inflated balloon prevents
the plug from extending into the vessel. Id. After the
plug is positioned, the user removes the balloon catheter,
leaving the plug in the puncture to promote healing. Id.
col.5 ll.6–9. This arrangement is seen in Figure 3 of the
Fowler patents, reproduced below.
3 The Fowler patents share a common written de-
scription; therefore, we only refer to the written descrip-
tion of the ’616 patent.
8 ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC.
Two claims from the Fowler patents, dependent claim
14 of the ’616 patent and independent claim 21 of the ’375
patent, are involved in this appeal. Claim 21 is generally
representative and recites, “a vessel plug” and “at least a
portion of [a] positioning member [that] is expandable . . .
to position said vessel plug in the incision proximally of
the blood vessel such that said vessel plug obstructs the
flow of blood through the incision without extending into
the blood vessel.” ’375 patent, col.10 ll.12–22.
C. Procedural History
St. Jude filed its complaint in the United States Dis-
trict Court for the Western District of Arkansas on Octo-
ber 22, 2008, alleging that ACI infringed several of its
patents, including the Janzen patent and the Fowler
patents. During the litigation, the district court issued a
Markman order in which it construed various claim terms
found in the Janzen patent, including “means for ejecting”
and “ejecting mechanism.” See St. Jude Med., Inc. v.
Access Closure, Inc., 4:08-CV-04101-HFB, 2010 WL
2868507 (W.D. Ark. July 19, 2010). The parties proceeded
to trial before a jury.
The jury rendered a verdict that ACI had infringed
claims 7 and 8 of the Janzen patent, but that claims 7, 8,
and 9 of the Janzen patent were invalid for double patent-
ing in light of the sibling ’498 patent. Implicit in the
jury’s double patenting finding was the jury’s conclusion
that claims 7, 8, and 9 of the Janzen patent were not
patentably distinct from claim 7 of the sibling patent.
The district court termed the jury’s double patenting
finding an “advisory opinion” since the court had withheld
from the jury the question of whether the safe harbor
provision in 35 U.S.C. § 121 prevented the claims from
being invalidated. St. Jude Med., Inc. v. Access Closure,
Inc., 08-CV-4101, 2011 WL 5374424, at *1 (W.D. Ark.
Nov. 8, 2011). The district court then held a bench trial to
determine whether the safe harbor provision applied to
ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC. 9
the Janzen claims. The court concluded that the safe
harbor did apply, thus overturning the jury’s invalidity
finding, and upholding the validity of the claims. Id.
With regard to the Fowler patents, the jury found that
ACI had infringed claim 14 of the Fowler ’616 patent, and
claim 21 of the Fowler ’375 patent. The jury also found
that ACI willfully infringed the Fowler claims. Regarding
validity, the jury found that the Fowler claims were not
obvious and thus valid.
After the jury rendered its verdict, ACI filed a re-
newed JMOL motion on various issues. The district court
denied ACI’s motion. J.A. 119–20.
ACI now appeals the district court’s application of the
safe harbor provision to the Janzen patent, the court’s
construction of the claim terms “means for ejecting” and
“ejecting mechanism” from the Janzen patent (see Janzen
patent col.10 l.21 and col.10 l.66, respectively), and the
court’s denial of ACI’s renewed motion for JMOL that the
Fowler claims are invalid for obviousness.4
4 In the trial court proceedings, ACI raised the
question of whether the safe harbor provision in § 121
applied at all since the Janzen patent and the sibling
patent are continuation patents, not divisional patents.
The trial court rejected that argument, concluding that,
though they are continuations, they descended from a
divisional application filed as a result of the restriction
requirement, citing prior Federal Circuit cases. St. Jude
Med., Inc. v. Access Closure, Inc., 08-CV-4101, 2011 WL
5374424, at *4 (W.D. Ark. Nov. 8, 2011). We agree with
the trial court, and with Judge Lourie (see Concurrence at
2), that on these facts the safe harbor provision as a
general proposition is an available defense to a double-
patenting charge; because we hold the defense fails on
10 ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC.
We have jurisdiction over this appeal under
28 U.S.C. § 1295(a)(1).
II. DISCUSSION
A. The Janzen Patent and The Safe Harbor Provision
1.
We first address the district court’s application of the
safe harbor provision to the Janzen patent. The safe
harbor provision arose from difficulties created by re-
striction requirements imposed by the U.S. Patent and
Trademark Office (PTO) during examination, followed by
double patenting challenges in the courts. A restriction
requirement arises during examination at the PTO when
an applicant pursues what are determined to be multiple
patentably distinct inventions in the same application (see
35 U.S.C. § 121). Subsequently, a double patenting
challenge may arise when, in an infringement suit, the
patentee is charged with having pursued the same or
obviously similar inventions in multiple applications, one
or more of which later issued as the patent in suit (see In
re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985)). A successful
double patenting defense invalidates the offending claims
in the patent.
Prior to the 1952 Patent Act, when § 121 was enacted,
patentees could be faced with a situation in which the
PTO and courts caused these two doctrines to collide. To
illustrate, assume the PTO imposes a restriction require-
ment on a patent application because the PTO concludes
that the application claims invention A and invention B
which are deemed to be patentably distinct inventions.
The applicant then removes claims to invention B from
other grounds, however, we need not further address or
decide this aspect of the safe harbor issue.
ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC. 11
the restricted application and files those claims in a
subsequent application. The restricted application and
the subsequent application later issue as patents.
In a later court challenge, a court concludes that in-
vention A and invention B are not patentably distinct,
and thus the claims in the patent resulting from the
subsequent application are invalid for double patenting of
the same invention. See Remington Rand Bus. Serv. v.
Acme Card Sys. Co., 71 F.2d 628, 633–34 (4th Cir. 1934);
see also In re Kauffman, 152 F.2d 991, 993 (C.C.P.A.
1946). This conflicting result was recognized as inherent-
ly unfair, and the safe harbor was created to preclude it.
Studiengesellschaft Kohle mbH v. N. Petrochemical Co.,
784 F.2d 351, 358 (Fed. Cir. 1986) (Newman, J., concur-
ring).
The safe harbor provision states:
A patent issuing on an application with respect to
which a requirement for restriction under this
section has been made, or on an application filed
as a result of such a requirement, shall not be
used as a reference either in the Patent and
Trademark Office or in the courts against a divi-
sional application or against the original applica-
tion or any patent issued on either of them if the
divisional application is filed before the issuance
of the patent on the other application.
35 U.S.C. § 121.
The safe harbor provision, not a model of clarity, is at
the center of the parties’ dispute over the validity of the
Janzen patent.
2.
ACI contends that the Janzen patent violates conso-
nance. The judicially-created consonance concept derives
from the safe harbor’s “as a result of” requirement and
12 ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC.
specifies that the “line of demarcation between the ‘inde-
pendent and distinct inventions’ that prompted the re-
striction requirement be maintained.” Gerber Garment
Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 688 (Fed. Cir.
1990). An applicant’s pursuit of two or more non-elected
inventions in the same subsequent application does not by
itself violate the line of demarcation. See Boehringer
Ingelheim Int’l GmbH v. Barr Labs, Inc., 592 F.3d 1340,
1350 (Fed. Cir. 2010) (“The safe harbor is provided to
protect an applicant from losing rights when an applica-
tion is divided. The safe harbor of § 121 is not lost if an
applicant does not file separate divisional applications for
every invention or when independent and distinct inven-
tions are prosecuted together.”). However, in Gerber, we
concluded that “[p]lain common sense dictates that a
divisional application filed as a result of a restriction
requirement may not contain claims drawn to the inven-
tion set forth in the claims elected and prosecuted to
patent in the parent application.” Gerber, 916 F.2d
at 687.
The requirement for consonance applies to both the
patent challenged for double patenting (the challenged
patent) and the patent being used as a reference against
the challenged patent (the reference patent). Boehringer,
592 F.3d at 1352 (“We have repeatedly held that the ‘as a
result of’ requirement applies to the challenged patent as
well as the reference patent.”). Consonance in a case like
this requires that the challenged patent, the reference
patent, and the patent in which the restriction require-
ment was imposed (the restricted patent) do not claim any
of the same inventions identified by the examiner.
Looking first at the restricted patent—in this case the
grandparent—defendant ACI argues that the Examiner’s
Action in the grandparent application defined two inven-
tions: the device of Group I and the method of Group II.
And, as earlier noted, the grandparent patent that issued
included only claims to the device of Group I. According
ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC. 13
to ACI, the restriction requirement into two Groups set
the line of demarcation, and the election of species had no
effect on that line. Consequently, the Janzen patent
crossed the line of demarcation since it contained claims
to both a device (Group I) and a method (Group II), and
thus violated consonance.
St. Jude argues that the election of species in the
grandparent application did affect the line of demarca-
tion. According to St. Jude, the Examiner’s Action im-
posed a multi-level restriction: the device/method
restriction at a first level and the election of species at a
second level. Thus, the Examiner’s Action demarcated
not two, but six different inventions: Group I, Species A;
Group I, Species B; Group I, Species C; Group II, Species
A; Group II, Species B; and Group II, Species C. St. Jude
asserts that the claims of the Janzen patent maintained
consonance since the Janzen patent included claims to
Group I, Species C and Group II, Species C, which did not
overlap with the inventions, Group I, Species B, pursued
in the grandparent patent.
The parties’ dispute turns in large measure on the na-
ture and effect of the examiner-imposed election of spe-
cies. An election of species is similar to a restriction and
again is explained best by example. An applicant may file
an application containing claims to a generic invention,
such as a widget. The application may also include claims
to several patentably distinct species of the generic inven-
tion, such as the widget + X, the widget + Y, and the
widget + Z.
After reviewing the application, the examiner may
impose an election of species that requires the applicant
to choose one of the species for examination. The election
of species, like a typical restriction, helps the examiner to
focus the examination process. The applicant typically
elects a species (e.g., widget + X), focuses on prosecuting
the generic claims to the widget and any claims to the
14 ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC.
widget + X species, and withdraws the claims to the non-
elected species, widget + Y and widget + Z. If the generic
claim to the widget is allowed, the applicant may obtain
claim coverage on all of the species. If the generic claim is
not allowed, the application is restricted.
The PTO regulation that formally sets forth the
framework for an election of species is 37 C.F.R. § 1.146:
In the first action on an application containing a
generic claim to a generic invention (genus) and
claims to more than one patentably distinct spe-
cies embraced thereby, the examiner may require
the applicant in the reply to that action to elect a
species of his or her invention to which his or her
claim will be restricted if no claim to the genus is
found to be allowable.
Thus, § 1.146 states that if no generic claim is found
allowable, then the election of species will create a re-
striction under 35 U.S.C. § 121. 37 C.F.R. § 1.146 (“his or
her claim will be restricted if no claim to the genus is
found to be allowable”) (emphasis added).5
Returning to the parties’ arguments, ACI agrees that
the method/device restriction in the grandparent applica-
tion affected the line of demarcation, but argues that the
election of species did not affect the line because an elec-
tion of species is inherently different from a restriction
requirement.
This argument overlooks a critical point in this case:
the grandparent application lacked a generic claim. The
Examiner’s Action that included the restriction require-
ment and election of species in the grandparent applica-
5 Section 1.146 cites to 35 U.S.C. § 121 as statutory
authority.
ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC. 15
tion stated that “no claims are generic.” J.A. 18,558. The
allowed and issued claims likewise lacked a generic claim.
The Examiner’s Action stated the consequences if the
claims of the application were held allowable without a
generic claim: “Applicant is required under
35 U.S.C. § 121 to elect a single disclosed species for
prosecution on the merits to which the claims shall be
restricted if no generic claim is finally held allowable.”
J.A. 18,558 (emphasis added). Since no generic claim was
applied for, and no such claim was finally held allowable,
that is what occurred: the election of species in the grand-
parent created a restriction.6 Thus, there were two re-
striction requirements imposed on the grandparent
application: the original device/method restriction, and
the second restriction that resulted from the election of
species.
It makes logical sense that the election of species af-
fected the line of demarcation when no claim was generic.
If the election of species did not affect the line, double
patenting would have prevented the Janzen applicant
from obtaining valid claims directed to non-elected spe-
cies. This result would be unfair since it was the examin-
er, not the applicant, who created the further division of
the application with the election of species, and the exam-
6 We note that § 1.146 contemplates imposing an
election of species in an application having a generic
claim. 37 C.F.R. § 1.146 (“In the first action on an appli-
cation containing a generic claim to a generic inven-
tion . . . .”) (emphasis added). Since the parties do not
concern themselves with the issue of whether an examin-
er can impose an election of species when no generic claim
is in the application, we assume for purposes of this case
that the Examiner had authority to do so. See 35 U.S.C
§ 121.
16 ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC.
iner already stated on the record that the non-elected
species were patentably distinct from the elected species.
The unfairness of the result would violate the purpose of
the safe harbor.
For these reasons, we hold that the restriction result-
ing from the election of species affected the line of demar-
cation. In particular, the first restriction separated Group
I from Group II, and the second restriction operated on
top of the first restriction to separate the Species.
3.
With the line of demarcation settled, we must deter-
mine whether that line was honored—that is, whether
any of the same restricted inventions are claimed in the
challenged patent (the Janzen patent), the reference
patent (the sibling patent), or the restricted patent (the
grandparent patent). We review whether the require-
ments of § 121 have been satisfied as a question of law
and without deference. Bristol-Myers Squibb Co. v.
Pharmachemie B.V., 361 F.3d 1343, n.1 (Fed. Cir. 2004).
As noted above, the two restrictions placed upon the
grandparent application together carved out Species A, B,
and C. The Janzen application pursued Group I, Species
C and Group II, Species C, which were different than the
invention pursued in the grandparent application, Group
I, Species B. Therefore, the line of demarcation was
maintained in this respect.
However, turning to the sibling patent, we conclude
that consonance was not maintained. The sibling patent’s
independent claim 1 is drawn to a method of sealing a
puncture in a wall of a blood vessel involving neither a
guidewire nor a dilator (i.e., a claim directed to Group II,
but not limited to any of Species A, B, or C). Thus the
sibling application was not filed “as a result” of the re-
striction since it pursued a claim generic to all of the
ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC. 17
Species in Group II, and therefore overlapped Group II,
Species C found in the Janzen patent.
The jury found that claims 7, 8, and 9 of the Janzen
patent are not patentably distinct from claims of the
sibling patent. The trial court saved invalidity under this
finding based on double patenting rules by applying the
safe harbor provision. Since we conclude that the Janzen
patent and the sibling patent did not maintain conso-
nance, and therefore the safe harbor provision cannot
apply, we hold that claims 7, 8, and 9 of the Janzen pa-
tent are invalid. The trial court’s ruling to the contrary is
reversed.
B. The Janzen Patent and Claim Construction
ACI also appeals the district court’s construction of
“means for ejecting” and “ejecting mechanism” from
claims 7 and 8 of the Janzen patent. Because we hold
that these claims are invalid for double patenting, the
claim construction issue is now moot.
C. The Fowler Patents and Obviousness
We last turn to ACI’s argument that the Fowler pa-
tents are invalid for obviousness. To argue obviousness,
ACI relies on a 1988 article by Kenichi Takayasu, M.D., et
al., that describes a method and device for sealing a
puncture in a liver vein with a compressed “gelfoam
stick.” Takayasu et al., “A New Hemostatic Procedure for
Percutaneous Transhepatic Portal Vein Catheterization,”
Jpn. J. Clin. Oncol. 18:227-30 (1988) (“Takayasu”). ACI
also argues obviousness based on a 1971 article by Karl
Smiley that describes a technique for blocking bleeding
from a vessel using a balloon catheter. Smiley and Perry,
“Balloon Catheter Tamponade of Major Vascular
Wounds,” Am. J. of Surgery, 326-27 (1971) (“Smiley”).
According to ACI, Takayasu and Smiley establish that
there was a known problem in the art—achieving hemo-
stasis in punctured or damaged blood vessels—and the
18 ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC.
prior art references both disclosed methods of solving that
problem. ACI argues that a person of ordinary skill in the
art would have reasonably expected to permanently stop
bleeding in blood vessels by combining the techniques
described in Takayasu and Smiley in the manner claimed
by the Fowler patents. For these reasons, ACI argues
that claim 14 of the Fowler ’616 patent, and claim 21 of
the Fowler ’375 patent are invalid for obviousness under
35 U.S.C. § 103.
In response, St. Jude contends that both prior art ref-
erences fail to disclose the Fowler patent’s claimed feature
of a balloon configured to operate as a positioning device
to prevent a plug from entering a blood vessel. In particu-
lar, St. Jude argues that the references lack “an elongate
positioning member . . . to position said vessel plug . . .
without extending into the blood vessel” from claim 21 of
the ’375 patent and “inflating a member on an insertion
member to identify the location of the blood vessel adja-
cent to the incision” and “positioning the vessel plug in
the incision such that the distal end of the vessel plug is
located proximally of the blood vessel” from the combina-
tion of independent claim 9 and its dependent claim 14 of
the ’616 patent.
We review the jury’s conclusions on obviousness with-
out deference and the underlying findings of fact for
substantial evidence. The Johns Hopkins Univ. v. Data-
scope Corp., 543 F.3d 1342, 1345 (Fed. Cir. 2008). We see
no error in the district court’s legal conclusion of non-
obviousness. Neither Takayasu nor Smiley discloses a
balloon configured to operate as a positioning device to
prevent a plug from entering a blood vessel as claimed in
the Fowler patents. Takayasu discloses no balloon at all,
and Smiley discloses a balloon that is used to control the
bleeding of a gunshot wound or an abdominal aneurism.
Moreover, we are not persuaded by ACI’s arguments
to combine the teachings of Takayasu and Smiley. ACI
ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC. 19
points to Takayasu and Smiley, arguing that achieving
hemostasis in blood vessels was a known problem in the
art. But we note that Takayasu and Smiley both teach
the same thing to overcome this problem: inserting an
object into a wound to help achieve hemostasis. Takayasu
teaches inserting a gelfoam stick, and Smiley teaches
inserting a balloon. One of ordinary skill in the art at the
time of the invention would have viewed the balloon and
the gelfoam stick as substitutes to achieve the same
hemostasis objective, not as complementary devices to
achieve the positioning benefit of St. Jude’s claimed
invention.
ACI also notes that Takayasu discloses visualizing the
placement of the gelfoam stick with x-ray and ultrasound
imaging. Presumably, ACI is suggesting that since x-ray
and ultrasound were used to place a gelfoam stick, it
would have been obvious to one of skill in the art at the
time of the invention to use a balloon to prevent a plug
from entering a blood vessel. But ACI fails to explain why
it would have been obvious to do so. Certainly the balloon
in Smiley is not used to position a plug as claimed, and
ACI provides no evidence that a balloon had ever been so
used. Nor does ACI explain why common sense would
lead one of ordinary skill in the art to abandon the non-
invasive x-ray and ultrasound technology in favor of an
invasive, inflatable balloon.
Therefore, while Takayasu does disclose using x-ray
and ultrasound to help place a gelfoam stick, between this
disclosure and the claimed invention lies a logical
chasm—a chasm not bridged by the prior art, common
sense, or ACI’s statements that the claimed invention was
obvious. Even under our “expansive and flexible” obvi-
ousness analysis (see KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 415, (2007)), we must guard against “hindsight
bias” and “ex post reasoning” (id. at 421). Doing so here
compels us to reject ACI’s argument.
20 ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC.
ACI further contends that, because St. Jude’s expert
Dr. Kovacs allegedly provided only conclusory testimony,
the district court erred by rejecting ACI’s proposed combi-
nation. Dr. Kovacs testified that the proposed combina-
tion of Takayasu and Smiley was “very, very far out and it
makes no sense to me whatsoever” and “[c]ombining two
references which are independently farfetched is
farfetched times farfetched, it’s farfetched squared.” J.A.
10634–35.
Even if Dr. Kovacs provided conclusory testimony,
ACI did not carry its burden of proving invalidity. We
have held that “[s]ince we must presume a patent valid,
the patent challenger bears the burden of proving the
factual elements of invalidity by clear and convincing
evidence.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1359
(Fed. Cir. 2007). This burden of proof never shifts to the
patentee. Id. ACI failed to carry its burden of proof.
Therefore, ACI’s arguments about Dr. Kovacs are imma-
terial.
We find each of ACI’s obviousness arguments without
merit and affirm the district court’s refusal to grant ACI’s
renewed motion for JMOL.
III. CONCLUSION
For the foregoing reasons, we conclude that the dis-
trict court should be affirmed-in-part and reversed-in-
part.7
AFFIRMED-IN-PART; REVERSED-IN-PART
7 We do not rule on any decision issued by the dis-
trict court to enhance damages relating to the jury’s
finding of willfulness.
United States Court of Appeals
for the Federal Circuit
______________________
ST. JUDE MEDICAL, INC., AND ST. JUDE MEDICAL
PUERTO RICO, LLC,
Plaintiffs-Appellees,
v.
ACCESS CLOSURE, INC.,
Defendant-Appellant.
______________________
2012-1452
______________________
Appeal from the United States District Court for the
Western District of Arkansas in No. 08-CV-4101 Senior
Judge Harry F. Barnes.
______________________
LOURIE, Circuit Judge, concurring.
I agree with the results of the majority opinion in all
respects, but I would arrive at the conclusion of invalidity
of the ’439 Janzen patent by a different route.
In a nutshell, this case is resolved by the failure of
the granted Janzen and ’498 (sibling) patents to maintain
consonance with the original restriction requirement. The
accompanying requirement for election of species, which
perhaps raises an issue of first impression, is a complica-
tion that should not come into play in deciding the appeal.
That is where I differ with the majority opinion and the
district court.
2 ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC.
Under § 121, “[a] patent issuing on an application
with respect to which a requirement for restriction under
this section has been made, or on an application filed as a
result of such a requirement, shall not be used as a refer-
ence . . . against a divisional application or against the
original application or any patent issued on either of
them, if the divisional application is filed before the
issuance of the patent on the other application.” 35
U.S.C. § 121.
First, it is worthy of note that this provision contem-
plates that it is divisional applications that are filed
pursuant to a restriction, and the Janzen patent issued on
a continuation, not a divisional application. The very title
of § 121 is “Divisional applications.” It refers to divisional
applications three times, twice in relation to the immuni-
ty from double patenting issue. However, we have held
that the protections of § 121 are not vitiated by the pres-
ence of a continuation application in a chain of applica-
tions, even though the statute refers only to divisionals.
Amgen Inc. v. Hoffmann-La Roche Ltd., 580 F.3d 1340,
1354 (Fed. Cir. 2009). Thus, I agree that the ’498 sibling
patent would fall within the § 121 safe harbor, as it issued
on a continuation application and, being limited to meth-
ods, maintains consonance with the original restriction
requirement between devices and methods.
However, regarding the Janzen patent, our case law
has held that a subsequent divisional application claiming
immunity under §121 must claim subject matter “conso-
nant” with the restriction requirement. Geneva Pharm.,
Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1381 (Fed.
Cir. 2003); Gerber Garment Tech., Inc. v. Lectra Sys., Inc.,
916 F.2d 683, 688 (Fed. Cir. 1990). That did not occur
here with Janzen. The restriction requirement required
dividing claims to devices from claims to methods, and the
Janzen patent contains both device and method claims. It
is the opposite of consonant. The district court referred to
the consonance issue as the “most challenging issue” in
ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC. 3
the case, and I believe it is dispositive of the result, alt-
hough not as the district court decided it.
The application that led to the ’183 (grandparent) pa-
tent was subjected to a restriction requirement, distin-
guishing between claims 1-38, drawn to devices, and
claims 39-94, drawn to methods. While the applicants
elected to prosecute the claims to devices, they then acted
contrary to that election, filing another divisional applica-
tion, still containing claims to both devices and methods.
They received the same restriction requirement. They
then filed continuation applications that issued as the
Janzen patent and the ’498 sibling patent. The Janzen
patent thus claimed both devices and methods, contrary
to the applicants’ previous elections and not consonant
with their election to prosecute the device claims in the
earlier application and hence the method claims else-
where.
In the parent application that preceded both the Jan-
zen patent and the ’498 sibling patent, the patent exam-
iner, beyond making a restriction requirement, also
required an election of species from what were referred to
as patentably distinct species A, B, and C, stating “the
claims shall be restricted if no generic claim is finally held
to be allowable. Currently no claims are generic.” Such a
requirement for election of species is not the same as a
restriction requirement. It is tentative and its conse-
quences are avoidable by the applicant obtaining the
allowability of a generic claim encompassing the various
species or by filing separate applications to pursue the
nonelected subject matter. In my view, the district court
and the majority err in even considering the effect of the
requirement for election of species in this case.
The district court analyzed claim 7 of the ’498 sibling
patent and concluded that the consonance issue was
contingent upon whether claim 7 describes a dilator and
guidewire—species B—whereas the claims of the Janzen
4 ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC.
patent elected species C, limited to a guidewire alone.
The court concluded that claim 7 of the ’498 sibling patent
was directed to species B, and the claims of the Janzen
patent to species C, so, in its view, there was no conso-
nance problem.
I agree with the majority that the district court erred
in failing to recognize that the Janzen patent contains
both claims to methods (9-10) and claims to devices (1-8).
Thus, the Janzen claims are not consonant with the
restriction requirement in the grandparent and parent
patents. As such, whether filed as a divisional or a con-
tinuation, the Janzen patent does not receive the benefit
of § 121’s immunity from double patenting. As indicated,
and contrary to the reasoning of the majority, it is not the
distinction between species that is the issue, because they
arose from a requirement to elect species pending the
allowability of a generic claim, but to the distinction
between the method and device inventions that were
actually the subject of the original restriction require-
ment.
Thus, I disagree with the majority’s commingling of
the restriction requirement and requirement for an elec-
tion of species. The election of species requirement was
not a restriction requirement. It was not final, but was
contingent on the absence of an allowable generic claim.
If there was no generic claim, as appears to be the case,
then the applicant could have argued that the species
were not independent and distinct inventions. Alterna-
tively, a separate application could have been filed on
non-elected species.
It is true that 37 C.F.R. § 1.146, dealing with election
of species, states that the “claim will be restricted if no
claim to the genus is found to be allowable.” But the
appearance of the word “restriction” in the rule relating to
election of species does not make it another requirement
ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC. 5
for restriction piled onto the § 121 requirement for re-
striction.
The Boehringer case, cited in the majority opinion on-
ly for a lesser point, does not change this analysis. It does
not deal with an election of species, just a requirement for
restriction.
I therefore believe that the majority opinion overcom-
plicates the analysis of this appeal and improperly com-
mingles restriction practice with election of species
practice. But I nonetheless agree with its conclusions.