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 & Sullivan, 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”), plaintiffs 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 doublepatenting; (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 devices for sealing a ‘vascular puncture.’ A vascular puncture 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 professional 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. 

Continuation 

Parent 

Patent 

Janzen 

Patent 

Sibling 

Patent 

Grandparent

Patent 

Divisional 

Continuation 
 4 ST. JUDE MEDICAL, INC. v. ACCESS CLOSURE, INC. 

The Janzen patent discloses a medical device that inserts 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 representative 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 member,” “[a] plug member . . . disposed in said elongated 

member,” and “an ejecting mechanism for ejecting said 

plug member from [a] distal end of said elongated member 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 sealing a puncture in a wall of a blood vessel. 

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 examiner stated that the claims included patentably distinct 

Species A, B, and C (as described below), and the Examiner’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 device/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 restrictions 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 canceled the original claims and copied both device and 

method claims from a different patent to provoke an 

interference proceeding. The Janzen application ultimately 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 contacts 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 description; therefore, we only refer to the written description 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 District Court for the Western District of Arkansas on October 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 patenting 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 renewed 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 doublepatenting 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 restriction 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 requirement 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 invention 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 inherently 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., concurring). 

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 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. 

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 consonance. 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 ‘independent and distinct inventions’ that prompted the restriction 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 application 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 inventions 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 invention 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 requirement 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 inventions: 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 demarcation. According to St. Jude, the Examiner’s Action imposed 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 nature and effect of the examiner-imposed election of species. 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 invention, 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 nonelected 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 species 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 restriction 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 application affected the line of demarcation, but argues that the 

election of species did not affect the line because an election 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 requirement 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 grandparent created a restriction.6 Thus, there were two restriction 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 affected 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 species. This result would be unfair since it was the examiner, 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 application containing a generic claim to a generic invention . . . .”) (emphasis added). Since the parties do not 

concern themselves with the issue of whether an examiner 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 resulting from the election of species affected the line of demarcation. 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 determine 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 requirements 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 restriction 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 consonance, and therefore the safe harbor provision cannot 

apply, we hold that claims 7, 8, and 9 of the Janzen patent 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 patents 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 hemostasis 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 references 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 particular, 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 adjacent 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 combination of independent claim 9 and its dependent claim 14 of 

the ’616 patent. 

We review the jury’s conclusions on obviousness without deference and the underlying findings of fact for 

substantial evidence. The Johns Hopkins Univ. v. Datascope Corp., 543 F.3d 1342, 1345 (Fed. Cir. 2008). We see 

no error in the district court’s legal conclusion of nonobviousness. 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 noninvasive 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” obviousness 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 combination. Dr. Kovacs testified that the proposed combination 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 immaterial. 

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 district court should be affirmed-in-part and reversed-inpart.7 

AFFIRMED-IN-PART; REVERSED-IN-PART 

 

7 We do not rule on any decision issued by the district 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 complication 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 reference . . . 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 contemplates 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 immunity from double patenting issue. However, we have held 

that the protections of § 121 are not vitiated by the presence of a continuation application in a chain of applications, 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 methods, 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 “consonant” 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, although not as the district court decided it. 

The application that led to the ’183 (grandparent) patent was subjected to a restriction requirement, distinguishing 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 application, 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 elsewhere. 

In the parent application that preceded both the Janzen patent and the ’498 sibling patent, the patent examiner, 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 consequences 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 consonance 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 continuation, 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 requirement.

Thus, I disagree with the majority’s commingling of 

the restriction requirement and requirement for an election 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. Alternatively, 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 restriction.

The Boehringer case, cited in the majority opinion only 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 overcomplicates the analysis of this appeal and improperly commingles restriction practice with election of species 

practice. But I nonetheless agree with its conclusions.