C R Bard Inc. v. Angiodynamics, Inc.

Case: 19-1756 Document: 72 Page: 1 Filed: 11/10/2020

United States Court of Appeals
for the Federal Circuit
______________________

C R BARD INC., BARD PERIPHERAL VASCULAR,
INC.,
Plaintiffs-Appellants

v.

ANGIODYNAMICS, INC.,
Defendant-Appellee
______________________

2019-1756, 2019-1934
______________________

Appeals from the United States District Court for the
District of Delaware in No. 1:15-cv-00218-JFB-SRF, Senior
Judge Joseph F. Bataillon.
______________________

Decided: November 10, 2020
______________________

DEANNE MAYNARD, Morrison & Foerster LLP, Wash-
ington, DC, argued for plaintiffs-appellants. Also repre-
sented by SETH W. LLOYD, BRIAN ROBERT MATSUI; VINCENT
JOSEPH BELUSKO, DYLAN JAMES RAIFE, Los Angeles, CA.

DANIELLE VINCENTI TULLY, Cadwalader, Wickersham
& Taft LLP, New York, NY, argued for defendant-appellee.
Also represented by JACLYN HALL, CHRISTOPHER A.
HUGHES, JOHN MOEHRINGER, MICHAEL BRIAN POWELL.
______________________
Case: 19-1756 Document: 72 Page: 2 Filed: 11/10/2020

2 C R BARD INC. v. ANGIODYNAMICS, INC.

Before REYNA, SCHALL, and STOLL, Circuit Judges.
REYNA, Circuit Judge.
The appellants, manufacturers of implantable medical
devices for intravascular injections, sued their competitor
for patent infringement. Partway through the jury trial,
the district court granted judgment that the asserted
claims were not infringed, were not willfully infringed, and
were invalid as directed to printed matter. We hold that
there was substantial evidence in the record to support a
jury finding of infringement and willfulness. We also hold
that the asserted claims are not directed solely to printed
matter, and thus are patent eligible under 35 U.S.C. § 101,
and that a genuine dispute of material fact precludes sum-
mary judgment as to anticipation. Thus, we reverse-in-
part and vacate-in-part the district court’s judgments and
remand for further proceedings.
BACKGROUND
A. The Technology, Patents, and Accused Products
The appellants, C. R. Bard Inc. and Bard Peripheral
Vascular, Inc. (collectively, “Bard”), and the appellee, An-
gioDynamics, Inc., are manufacturers of vascular access
ports, which are devices implanted underneath a patient’s
skin that allow medical providers to inject fluid into the pa-
tient’s veins on a regular basis without needing to start an
intravenous line each time. Vascular access ports were tra-
ditionally used to administer injections at a low pressure
and flow rate. However, certain procedures, like computed
tomography (“CT”) imaging, required injection of fluids
into patients at a high pressure and high flow rate. This
type of injection is referred to as “power injection.” As of
2005, vascular access ports were not specifically approved
by the FDA for use with power injection. Nonetheless, cer-
tain medical providers were using existing ports for power
injection, and in some cases, the pressure of the injection
ruptured the port, seriously injuring the patient. In light
Case: 19-1756 Document: 72 Page: 3 Filed: 11/10/2020

C R BARD INC. v. ANGIODYNAMICS, INC. 3

of these reported cases, the FDA cautioned medical provid-
ers in 2004 and 2005 that they should not use vascular ac-
cess ports for power injection unless the ports were
specifically and identifiably labeled for such use.
J.A. 31850–51, 32089.
At the time, Bard’s commercially marketed vascular
port product was already structurally suitable for power in-
jection, although it had not been approved for such use.
Around the time of the FDA warnings, Bard confirmed the
power injection capability of its product and proceeded to
develop identifiable features that would reliably convey
that capability to medical providers after the port was im-
planted. The primary identifying feature Bard developed
was a radiographic marker in the form of the letters “CT”
etched in titanium foil on the device. This marker could be
detected during an x-ray scan such as the “scout scan” typ-
ically performed at the start of a CT procedure. Other iden-
tifiers incorporated into the device included a triangular
shape and small bumps that were palpable through the
skin. Bard also included identifiers with its product that
were separate from the device itself, such as labeling on the
device packaging and small items to be carried by the pa-
tient or kept in the patient’s medical records (i.e. a key-
chain, wristband, or sticker). Bard obtained FDA approval
for its new product and launched it under the brand name,
PowerPort, as the first vascular access port labeled for
power injection.
Bard also filed patent applications claiming its strate-
gies for identifying a power injectable port. These applica-
tions eventually issued as the patents-in-suit in this case,
U.S. Patent Nos. 8,475,417, 8,545,460, and 8,805,478. The
patents have substantially similar written descriptions,
and each of the claims require the presence of a radio-
graphic marker identifying the claimed port as power in-
jectable.
Case: 19-1756 Document: 72 Page: 4 Filed: 11/10/2020

4 C R BARD INC. v. ANGIODYNAMICS, INC.

The ’417 and ’460 patents claim “assemblies” and “sys-
tems” for identifying a vascular access port as suitable for
power injection. Bard asserted claims 5, 6, 12, and 13 of
the ’417 patent, which each depend from either claim 1 or
claim 8; and dependent claims 2 and 4 of the ’460 patent,
which depend from claim 1. Claim 1 of the ’417 patent is
illustrative of these claims:
1. An assembly for identifying a power injectable
vascular access port, comprising:
a vascular access port comprising a body defining a
cavity, a septum, and an outlet in communication
with the cavity;
a first identifiable feature incorporated into the ac-
cess port perceivable following subcutaneous im-
plantation of the access port, the first feature
identifying the access port as suitable for flowing
fluid at a fluid flow rate of at least 1 milliliter per
second through the access port;
a second identifiable feature incorporated into the
access port perceivable following subcutaneous im-
plantation of the access port, the second feature
identifying the access port as suitable for accommo-
dating a pressure within the cavity of at least 35
psi, wherein one of the first and second features is
a radiographic marker perceivable via x-ray; and
a third identifiable feature separated from the sub-
cutaneously implanted access port, the third fea-
ture confirming that the implanted access port is
both suitable for flowing fluid at a rate of at least 1
milliliter per second through the access port and for
accommodating a pressure within the cavity of at
least 35 psi.
’417 patent col. 30 l. 51–col. 31 l. 6. The asserted dependent
claims of the ’417 and ’460 patents further require that the
radiographic marker be in the form of radiographic letters
Case: 19-1756 Document: 72 Page: 5 Filed: 11/10/2020

C R BARD INC. v. ANGIODYNAMICS, INC. 5

or other symbols, patterns, or characters, and that the ex-
trinsic identifier include one or more of a key chain, a
bracelet, a wrist band, a sticker provided on a patient’s
chart, a patient ID card, or a label provided on the product
packaging.
The ’478 patent claims methods for performing a power
injection procedure that include identifying a vascular ac-
cess port suitable for power injections and performing the
power injection. Bard asserted claims 3, 5, 9, and 11 of the
’478 patent, which each depend from either claim 1 or claim
8. Claim 8 is illustrative of the method claims:
8. A method of performing a power injection pro-
cedure, comprising:
providing an access port including a cannula-im-
penetrable housing and a radiographic feature in-
dicating that the access port is suitable for flowing
fluid at a rate of at least 1 milliliter per second
through the access port;
implanting the access port in a subcutaneous
pocket formed under a patient’s skin;
taking an image of the implanted access port via
imaging technology;
identifying the access port as being suitable for
flowing fluid at a rate of at least 1 milliliter per sec-
ond through the access port via the image of the
radiographic feature of the access port; and
injecting contrast media fluid through the access
port at a rate of at least 1 milliliter per second.
’478 patent col. 31 ll. 41–56. The asserted dependent
claims of the ’478 patent contain additional limitations con-
cerning the radiographic feature and external features that
are analogous to those in the asserted dependent claims of
the ’417 and ’460 patents.
Case: 19-1756 Document: 72 Page: 6 Filed: 11/10/2020

6 C R BARD INC. v. ANGIODYNAMICS, INC.

Not long after Bard obtained FDA approval for its Pow-
erPort product, AngioDynamics sought and obtained FDA
approval to market its own vascular access port products
as suitable for power injection. While its initial power in-
jection product did not include any features intrinsic to the
device that identified its functionality, the company added
identifiers such as a scalloped shape and a radiographic
“CT” marker to its later products for easier identification.
These new products were sold under the brand names
Smart Port CP, Smart Port LP, Smart Port mini, Xcela,
Xcela Plus, and BioFlo.
B. Procedural History
Bard sued AngioDynamics in the District of Delaware,
asserting that AngioDynamics’s power injectable vascular
access port products infringed the ’417, ’460, and ’478 pa-
tent claims. AngioDynamics moved to dismiss the com-
plaint on the ground that all claims of the patents-in-suit
were ineligible under § 101. The district court denied the
motion as premature. C. R. Bard, Inc. v. Angiodynamics,
Inc., 156 F. Supp. 3d 540, 554 (D. Del. 2016). The parties
later cross-moved for summary judgment on the questions
of patent eligibility, novelty, and enablement. Judge Ba-
taillon concluded that factual disputes remained on all is-
sues and denied the motions without prejudice. C R Bard,
Inc. v. AngioDynamics Inc., No. 1:15CV218, 2018
WL 3130622, at *12–13 (D. Del. June 26, 2018)
In advance of trial, the court requested a report and
recommendation from Magistrate Judge Fallon on certain
remaining claim construction issues, including whether
the “radiographic letters” and “visually perceptible infor-
mation” limitations were entitled to patentable weight
Case: 19-1756 Document: 72 Page: 7 Filed: 11/10/2020

C R BARD INC. v. ANGIODYNAMICS, INC. 7

under the printed matter doctrine. 1 Judge Fallon deter-
mined that these limitations were not entitled to patenta-
ble weight because they were directed to the content of
information that was not “functionally or structurally re-
lated” to the claimed ports. Bard Peripheral Vascular, Inc.
v. AngioDynamics, Inc., No. CV 15-218-JFB-SRF, 2019
WL 1996022, at *3–6 (D. Del. Feb. 11, 2019). The district
court adopted the recommendation.
The parties proceeded to trial. Bard presented its case
on infringement, willfulness, and damages through live
testimony from a named inventor, infringement expert
Timothy Clark, M.D., and a damages expert, along with
deposition testimony from AngioDynamics employees. At
the close of Bard’s case-in-chief, AngioDynamics moved for
judgment as a matter of law (“JMOL”) of non-infringement
and no willfulness. In asserting non-infringement, An-
gioDynamics argued that (1) Dr. Clark’s testimony could
not create triable issues of fact because he had improperly
interpreted the claims to require that the vascular access
port be “intended” for use with power injection, contrary to
the court’s claim construction; (2) Bard had not conducted
any testing to establish that AngioDynamics’s Xcela prod-
uct met the flow rate and pressure requirements of the as-
serted claims; and (3) there was no direct evidence that a
single entity directly infringed the ’478 patent’s method
claims. AngioDynamics also argued there was insufficient
evidence of willful infringement because AngioDynamics
had obtained invalidity opinions from counsel regarding

1 This followed our decision in Praxair that the ques-
tions of whether certain claim elements are directed to
printed matter and whether such printed matter is func-
tionally related to other claim elements may properly be
resolved during claim construction. Praxair Distrib., Inc.
v. Mallinckrodt Hosp. Prods. IP Ltd., 890 F.3d 1024, 1033
(Fed. Cir. 2018).
Case: 19-1756 Document: 72 Page: 8 Filed: 11/10/2020

8 C R BARD INC. v. ANGIODYNAMICS, INC.

the patents-in-suit and Bard had not shown that the opin-
ions were deficient.
In response to AngioDynamics’s JMOL motion, the
court asked the parties, sua sponte, whether the issue of
“patent eligibility and printed matter” was also ripe for de-
cision. J.A. 25849. The parties disagreed on the question.
The court terminated the trial, indicating that it would
grant JMOL on willfulness and ineligibility.
The court issued a written opinion granting AngioDy-
namics’s motion for JMOL of non-infringement and no will-
ful infringement. C R Bard Inc. v. AngioDynamics Inc.,
382 F. Supp. 3d 332, 335 & n.5, 337, 341 (D. Del. 2019). In
the same opinion, the court stated that the asserted claims
were invalid because they were directed to printed matter
as ineligible subject matter and were not inventive. Id. at
337–41. He followed this decision with an order “sus-
tain[ing] AngioDynamics’s oral motion for Judgment as a
Matter of Law, as well as its motions for summary judg-
ment under Federal Rule of Civil Procedure 56, on the
grounds that the claims of the Asserted Patents are inva-
lid, not patent-eligible, not infringed and not willfully in-
fringed.” J.A. 2.
Bard appeals the judgments of non-infringement, no
willfulness, and invalidity, including ineligibility under
§ 101. We have jurisdiction under 28 U.S.C. § 1295(a)(1).
DISCUSSION
We first address the court’s judgments on infringement
and invalidity. Applying the law of the regional circuit—
here, the Third Circuit—we review the district court’s
grant of JMOL and summary judgment de novo. See Ac-
umed v. Adv. Surgical Servs., 561 F.3d 199, 211 (3d Cir.
2009); Facenda v. NFL Films, Inc., 542 F.3d 1007, 1013
(3d Cir. 2008). A court may grant JMOL during a jury trial
only when (1) a party has been fully heard on an issue and
(2) the court finds that a reasonable jury would not have a
Case: 19-1756 Document: 72 Page: 9 Filed: 11/10/2020

C R BARD INC. v. ANGIODYNAMICS, INC. 9

legally sufficient evidentiary basis to find for the party on
that issue. FED. R. CIV. P. 50. A court will grant summary
judgment on a claim or defense when there is no genuine
dispute as to any material fact and a party is entitled to
judgment as a matter of law. FED. R. CIV. P. 56.
A. Infringement
The district court granted JMOL of non-infringement
on each of the three grounds raised by AngioDynamics:
(1) that Dr. Clark failed to apply the court’s claim construc-
tion for the terms “vascular access port” and “access port”
in rendering his opinion; (2) that Bard had not shown that
the accused Xcela product met the flow rate requirements
of the asserted claims because Bard had not tested the
product and relied only on AngioDynamics’s statements to
the FDA regarding the product’s capabilities; and (3) that
Bard’s evidence had not shown that a single entity per-
formed all claim steps of the asserted method claims of the
’478 patent. Bard, 382 F. Supp. 3d at 336–37. Bard chal-
lenges each of these grounds.
We agree with Bard that the district court erred in
granting JMOL. First, although Dr. Clark testified during
cross-examination that he believed there was an intent re-
quirement “implied” in the court’s construction of the “ac-
cess port” terms as “structured for power injection,” this
mistake did not undermine the factual basis of his infringe-
ment opinion. J.A. 25565–67. There is no indication from
the record that Dr. Clark relied on the intent aspect of his
claim interpretation in reaching his infringement opinion.
During his direct testimony, he testified that each of the
accused ports were suitable for power injection based on
evidence that they were structurally capable of withstand-
ing the pressures and flow rates used during such injec-
tions. This testimony did not rest on any conclusion that
the devices were intended for such use.
The court erroneously relied on our statement in Wie-
ner v. NEC Electronics, Inc. that an expert’s infringement
Case: 19-1756 Document: 72 Page: 10 Filed: 11/10/2020

10 C R BARD INC. v. ANGIODYNAMICS, INC.

testimony did not “create a factual dispute” where his opin-
ion “rest[ed] on an incorrect claim interpretation.”
102 F.3d 534, 542 (Fed. Cir. 1996). In Wiener, the expert’s
doctrine-of-equivalence opinion failed to apply the require-
ment, as construed on appeal, that certain claimed “col-
umns” be located on the data matrix of the claimed memory
chip. Id. Without an analysis of that essential require-
ment, the expert’s opinion on the issue of equivalence was
merely “conclusory.” Id. Our decision in Cordis Corp. v.
Boston Scientific Corp. is similarly distinguishable.
658 F.3d 1347, 1357 (Fed. Cir. 2011). There, we disre-
garded an infringement expert’s testimony that relied on
an incorrect understanding of the claim construction be-
cause the expert’s erroneously broad interpretation ig-
nored a specific requirement of the court’s construction. Id.
Here, even if Dr. Clark assumed that the claims required
an additional intent element, nothing in the record sug-
gests that this caused him to disregard the requirements of
the asserted claims under the correct construction. Alt-
hough the mistake might undermine his credibility, it does
not make his testimony legally insufficient to support an
infringement verdict. The district court thus erred in
granting JMOL on this basis.
Second, although Bard did not conduct its own tests of
the Xcela port’s suitability for power injection, Bard was
entitled to rely on AngioDynamics’s representations to its
customers and to the FDA that the Xcela port was suitable
for power injection at the flow rate and pressure required
by the claims. See J.A. 26640–41, 25300–01. Neither the
district court nor AngioDynamics provide any reason for
why direct testing evidence is required as a matter of law
to establish infringement under these circumstances. An-
gioDynamics’s statements regarding the capabilities of its
own product constituted substantial evidence of those ca-
pabilities. See FED. R. EVID. 801(d)(2). The weight as-
signed to that evidence was a question for the jury.
Case: 19-1756 Document: 72 Page: 11 Filed: 11/10/2020

C R BARD INC. v. ANGIODYNAMICS, INC. 11

Third, even if Bard did not present direct evidence of
specific instances in which an entity performed each of the
claimed steps of the ’478 patent, there was sufficient cir-
cumstantial evidence in the record to support AngioDy-
namics’s induced infringement of the method claims. This
court held in Toshiba Corp. v. Imation Corp. that “where
an alleged infringer designs a product for use in an infring-
ing way and instructs users to use the product in an in-
fringing way, there is sufficient evidence for a jury to find
direct infringement.” 681 F.3d 1358, 1365 (Fed. Cir. 2012).
This type of circumstantial evidence is sufficient for a jury
to “reasonably conclude that, sometime during the relevant
period[,] more likely than not one [entity] somewhere in the
United States” performed each of the claim steps, even
when there is no direct evidence of a specific person doing
so. Id. at 1366 (ellipsis omitted, alterations added). Here,
Dr. Clark testified that, in his professional experience,
(1) the steps of scanning, identifying, and injecting, as re-
quired by the asserted method claims, were generally per-
formed by a single CT technician (J.A. 25554–55), and
(2) the implantation of the port, as required by claims 9 and
11, were typically performed by another medical provider
at the same hospital, who would be acting as part of the
same “entity” as the medical providers performing the
other claim steps (J.A. 25533, 25539, 25558, 25569–70).
Dr. Clark also pointed to instructional materials provided
by AngioDynamics that directed medical providers to per-
form each step of the claimed methods. J.A. 25540; 26660–
71, 26783–90, 26803–08, 26820–25. This constituted sub-
stantial evidence to support a jury verdict of infringement
as to the method claims of the ’478 patent. Id.
For these reasons, the district court erred in granting
JMOL of non-infringement as to each of the asserted
claims.
Case: 19-1756 Document: 72 Page: 12 Filed: 11/10/2020

12 C R BARD INC. v. ANGIODYNAMICS, INC.

B. Willful Infringement
The district court granted judgment of no willful in-
fringement based on its conclusion that Bard had failed to
show infringement. In the alternative, the court held that
Bard had failed to meet its burden as to willfulness because
AngioDynamics had obtained written opinions of counsel
regarding the invalidity of the asserted claims of the pa-
tents-in-suit, and Bard had failed to show that the opinions
were “drafted by a bad law firm” or put forth other evidence
of willfulness. Bard, 382 F. Supp. 3d at 335 n.5. 2 This was
error.
Bard introduced evidence at trial that AngioDynamics’s
Director of Intellectual Property was aware of the applica-
tions that issued as the patents-in-suit prior to their issu-
ance. J.A. 25505, 25550, 25496. Bard also introduced
evidence that AngioDynamics intentionally copied Bard’s
CT radiographic marker based on market demand. Appel-
lants’ Br. 37–38. This is sufficient evidence to support a
jury verdict of willfulness. See Eko Brands, LLC v. Adrian
Rivera Maynez Enters., Inc., 946 F.3d 1367, 1377–79
(Fed. Cir. 2020) (discussing list of facts a jury can properly
consider in assessing willfulness); Polara Eng’g Inc. v.
Campbell Co., 894 F.3d 1339, 1353–54 (Fed. Cir. 2018) (dis-
cussing evidence of intentional copying of a competing
product as sufficient to support a verdict of willful infringe-
ment). While the existence of an invalidity opinion is a rel-
evant factor in determining willfulness, it was not
dispositive, and the question of whether AngioDynamics
reasonably believed that the asserted claims were invalid
was a question of fact for the jury. See Eko Brands,
946 F.3d at 1379.

2 While the district court stated that AngioDynamics
had obtained both invalidity and non-infringement opin-
ions, only invalidity opinions were presented at trial.
Case: 19-1756 Document: 72 Page: 13 Filed: 11/10/2020

C R BARD INC. v. ANGIODYNAMICS, INC. 13

C. Printed Matter and Invalidity
We first clarify procedural aspects of the district court’s
judgment before addressing the merits of validity. In its
final order, the district court granted both summary judg-
ment and JMOL that the patents were invalid and patent
ineligible, without specifying the statutory grounds for in-
validity. J.A. 1–4. At the time the motions were granted,
however, AngioDynamics had not yet presented its invalid-
ity case at trial and Bard had not had the opportunity to
defend the validity of its asserted claims. The district
court’s JMOL of invalidity was thus procedurally improper
because Rule 50 provides that JMOL against a party is only
appropriate once the party “has been fully heard on an is-
sue.” FED. R. CIV. P. 50.
For that reason, we consider the merits of the district
court’s invalidity judgment only as to the grounds on which
AngioDynamics moved for summary judgment, and only to
the extent we can reasonably read the district court’s deci-
sion as bearing on those grounds. In addressing the merits
of those grounds, we consider the entirety of the evidence
presented during summary judgment, not merely the facts
presented at trial. Here, AngioDynamics moved for sum-
mary judgment of invalidity based on subject matter ineli-
gibility, anticipation, and non-enablement. Because
nothing in the district court’s decision references or dis-
cusses enablement, we review the court’s validity judgment
only as to eligibility and anticipation, both of which impli-
cate the printed matter doctrine.
We conclude that although the asserted claims contain
printed matter that is not functionally related to the re-
maining elements of the claims, each claim as a whole is
patent eligible because none are solely directed to the
printed matter. We also conclude that when we assign no
patentable weight to the claimed printed matter, material
disputes of fact remain as to whether other elements of the
claim are novel over the prior art.
Case: 19-1756 Document: 72 Page: 14 Filed: 11/10/2020

14 C R BARD INC. v. ANGIODYNAMICS, INC.

1. Printed Matter
This court and its predecessor have long recognized that
certain “printed matter” falls outside the scope of patenta-
ble subject matter under U.S. patent law. See AstraZeneca
LP v. Apotex, Inc., 633 F.3d 1042, 1064 (Fed. Cir. 2010)
(“This court has generally found printed matter to fall out-
side the scope of § 101.”); In re Chatfield, 545 F.2d 152, 157
(CCPA 1976) (“Some inventions, however meritorious, do
not constitute patentable subject matter, e.g., printed mat-
ter.”). While historically “printed matter” referred to claim
elements that literally encompassed “printed” material,
the doctrine has evolved over time to guard against at-
tempts to monopolize the conveyance of information using
any medium. See Praxair Distrib., Inc. v. Mallinckrodt
Hosp. Prods. IP Ltd., 890 F.3d 1024, 1032 (Fed. Cir. 2018);
In re Distefano, 808 F.3d 845, 849 (Fed. Cir. 2015). Today,
printed matter encompasses any information claimed for
its communicative content, and the doctrine prohibits pa-
tenting such printed matter unless it is “functionally re-
lated” to its “substrate,” which encompasses the structural
elements of the claimed invention. Praxair, 890 F.3d at
1032; DiStefano, 808 F.3d at 848–49.
In evaluating the existence of a functional relationship,
we have considered whether the printed matter merely in-
forms people of the claimed information, or whether it in-
stead interacts with the other elements of the claim to
create a new functionality in a claimed device or to cause a
specific action in a claimed process. Thus, we held in In re
Marco Guldenaar Holding B.V., that the markings on dice
had no functional relationship to the dice themselves be-
cause the markings did not cause the dice to become a
“manufacture with new functionality.” 911 F.3d 1157,
1161 (Fed. Cir. 2018). We distinguished the dice markings
Case: 19-1756 Document: 72 Page: 15 Filed: 11/10/2020

C R BARD INC. v. ANGIODYNAMICS, INC. 15

from the digits printed on a circular band in Gulack 3—
where the digits exploited the band’s endless nature and
made it useful for performing mathematical operations—
and from the volumetric indicia on the side of a measuring
cup in Miller 4—where the indicia made the cup useful for
measuring partial recipes. Id. Based on analogous reason-
ing, we held in Praxair that there was a functional rela-
tionship between a step of recommending discontinuation
of treatment and a step of actually discontinuing treatment
because the claim required that the second step be “based
on” the first. 890 F.3d at 1035. In contrast, where the dis-
continuation step was absent from other claims of the same
patent, which merely required physicians to “evaluate” the
information, we found no functional relationship between
the information in the recommendation and the other steps
of the claim. Id. at 1033–35.
Here, the parties agree that the asserted claims include
printed matter. Each claim requires one or more markers
“identifying” or “confirming” that the implanted access port
is “suitable” either “for flowing fluid at a rate of at least 1
milliliter per second through the access port” or “for accom-
modating a pressure within the cavity of at least 35 psi,” or
both. These elements are directed to the content of the in-
formation conveyed.
The parties disagree, however, over whether this
printed matter is functionally related to the power injecta-
ble port, as recited in all the asserted claims, or to the step
of performing a power injection, as recited in the method
claims. Bard contends that the information conveyed by
the markers provides new functionality to the port because
it makes the port “self-identifying.” We disagree. A con-
clusion that mere identification of a device’s own

3 In re Gulack, 703 F.2d 1381, 1382–83 (Fed. Cir.
1983).
4 In re Miller, 418 F.2d 1392, 1393 (CCPA 1969).
Case: 19-1756 Document: 72 Page: 16 Filed: 11/10/2020

16 C R BARD INC. v. ANGIODYNAMICS, INC.

functionality is sufficient to constitute new functionality
for purposes of the printed matter doctrine would eviscer-
ate our established case law that “simply adding new in-
structions to a known product” does not create a functional
relationship. AstraZeneca, 633 F.3d at 1065 (citing In re
Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)). Indeed, as
early as the 1930s, our predecessor court recognized that
the mere marking of products, such as meat and wooden
boards, with information concerning the product, does not
create a functional relationship between the printed infor-
mation and the substrate. See In re McKee, 75 F.2d 991,
992 (CCPA 1935); In re Johns, 70 F.2d 913, 915 (CCPA
1934); In re Bruce, 56 F.2d 673, 674 (CCPA 1932).
Bard also contends that the printed matter is function-
ally related to the power injection step of the method claims
because the medical provider performs the power injection
“based on” the identification of the port’s functionality. But
there is no language in the claims suggesting such a causal
relationship. Bard did not advocate for that construction
before the district court, and we see no persuasive basis for
reading that limitation into the claims. Thus, we hold that
the content of the information conveyed by the claimed
markers—i.e. that the claimed access ports are suitable for
injection at the claimed pressure and flow rate—is printed
matter not entitled to patentable weight.
We next consider whether, in light of the claimed
printed matter, the district court properly concluded that
the asserted claims were invalid as ineligible or antici-
pated.
2. Subject Matter Eligibility
To determine whether claimed subject matter is patent
eligible, we apply the two-step framework set forth in Alice
Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014).
First, at step one, we “determine whether the claims at is-
sue are directed to a patent-ineligible concept,” such as an
abstract idea. Id. at 218. To determine if the claim’s
Case: 19-1756 Document: 72 Page: 17 Filed: 11/10/2020

C R BARD INC. v. ANGIODYNAMICS, INC. 17

character as a whole is directed to excluded subject matter,
we “look at the focus of the claimed advance over the prior
art.” Chamberlain Grp., Inc. v. Techtronic Indus. Co.,
935 F.3d 1341, 1346 (Fed. Cir. 2019) (quoting Affinity Labs
of Tex., LLC v. DIRECTV, LLC, 838 F.3d 1253, 1257 (Fed.
Cir. 2016)). If we conclude that the claim is directed to a
patent-ineligible subject matter, then at step two, we “ex-
amine the elements of the claim to determine whether it
contains an ‘inventive concept’ sufficient to ‘transform’” the
claimed ineligible subject matter into a patent-eligible ap-
plication. Alice, 573 U.S. at 221 (quoting Mayo Collabora-
tive Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 72, 80
(2012)). “The ‘inventive concept’ step requires us to look
with more specificity at what the claim elements add, in
order to determine whether they identify an ‘inventive con-
cept’ in the application of the ineligible subject matter to
which the claim is directed.” Chamberlain, 935 F.3d at
1348 (quoting Affinity Labs, 838 F.3d at 1258).
Although the underlying rationale of the printed mat-
ter doctrine lies in the requirements of subject matter eli-
gibility under § 101, our case law has typically applied the
doctrine to hold that specific limitations of a claim are not
entitled to patentable weight for purposes of novelty under
§ 102 and non-obviousness under § 103. See Praxair,
890 F.3d at 1032 (citing King Pharms., Inc. v. Eon Labs,
Inc., 616 F.3d 1267, 1279 (Fed. Cir. 2010), and In re Huai-
Hung Kao, 639 F.3d 1057, 1072–74 (Fed. Cir. 2011)). No-
tably, since the Supreme Court articulated its two-step
framework in Alice, this court has not directly addressed
whether a patent claim as a whole can be deemed patent
ineligible on the grounds that it is directed to printed mat-
ter at step one and contains no additional inventive concept
at step two.
Bard suggests that the answer is no. In support, Bard
cites to our decisions in Miller and King Pharmaceuticals,
where we declined to hold that claims covering printed
matter were patent ineligible under § 101 and instead
Case: 19-1756 Document: 72 Page: 18 Filed: 11/10/2020

18 C R BARD INC. v. ANGIODYNAMICS, INC.

evaluated whether the printed matter elements were enti-
tled to patentable weight for purposes of §§ 102 and 103.
But in neither case did we foreclose the possibility that an
entire claim could be found patent ineligible when the
claim as a whole is directed to printed matter. Rather, in
Miller, we recognized that “printed matter by itself is not
patentable subject matter, because [it is] non-statutory,” 5
and in King Pharmaceuticals, 6 we determined that the case
was not the right vehicle for a § 101 analysis because the
claim was plainly anticipated once the printed matter was
set aside. Indeed, eighty years ago, our predecessor court
held that “where the printed matter, irrespective of the
material upon which it is printed, is the sole feature of al-
leged novelty, it does not come within the purview of the
statute, as it is merely an abstract idea, and, as such, not
patentable.” McKee, 75 F.2d at 992. This is consistent with
the post-Alice decisions in which we have recognized that
the mere conveyance of information that does not improve
the functioning of the claimed technology is not patent-eli-
gible subject matter under § 101. See, e.g., Two-Way Media
Ltd. v. Comcast Cable Commc’ns, LLC, 874 F.3d 1329, 1338
(Fed. Cir. 2017) (concluding that claims directed to the
sending and receiving of information were unpatentable as
abstract where the steps did not lead to any “improvement
in the functioning of the system”); Elec. Power Grp., LLC v.
Alstom S.A., 830 F.3d 1350, 1354 (Fed. Cir. 2016) (holding
that claims directed to “a process of gathering and analyz-
ing information of a specified content, then displaying the
results, and not any particular assertedly inventive tech-
nology for performing those functions” are directed to an
abstract idea); Digitech Image Techs., LLC v. Elecs. for Im-
aging, Inc., 758 F.3d 1344, 1350 (Fed. Cir. 2014) (“Data in
its ethereal, non-physical form is simply information that
does not fall under any of the categories of eligible subject

5 Miller, 418 F.2d at 1396.
6 King Pharms., 616 F.3d at 1278.
Case: 19-1756 Document: 72 Page: 19 Filed: 11/10/2020

C R BARD INC. v. ANGIODYNAMICS, INC. 19

matter under section 101.”). We therefore hold that a claim
may be found patent ineligible under § 101 on the grounds
that it is directed solely to non-functional printed matter
and the claim contains no additional inventive concept.
With that understanding, we turn to the claims at issue
here. The asserted claims recite an assembly, system, or
method for identifying a vascular access port as power in-
jectable using multiple means for conveying the device’s
functionality, including, specifically, a radiographic
marker. When each claim is read as a whole, the focus of
the claimed advance is not solely on the content of the in-
formation conveyed, but also on the means by which that
information is conveyed. In particular, the claimed inven-
tion is described in the patents as satisfying a specific need
for easy vascular access during CT imaging, and it is the
radiographic marker in the claimed invention that makes
the claimed port particularly useful for that purpose be-
cause the marker allows the implanted device to be readily
and reliably identified via x-ray, as used during CT imag-
ing. See ’417 patent col. 1 l. 7–col. 3 l. 4.
In concluding that the claims could not be directed to
the claimed means for identifying functionality, the district
court accepted AngioDynamics’s assertion that all the
claimed forms of identification, including radiographic
marking, were routine and conventional in the art, and
thus could not constitute the patentable focus of the claims.
In defense of that position, AngioDynamics relies on Bard’s
admission that the use of radiographically identifiable
markings on implantable medical devices was known in
the prior art, and points to evidence of such use in the prior
art, including one vascular port with an x-ray tag that iden-
tified the port’s flow rate. Appellee’s Br. 48–49;
J.A. 17958–62. But even if we were to conclude that the
sole focus of the claimed advance was the printed matter,
AngioDynamics’s evidence is not sufficient to establish as
a matter of law, at Alice step two, that the use of a radio-
graphic marker, in the “ordered combination” of elements
Case: 19-1756 Document: 72 Page: 20 Filed: 11/10/2020

20 C R BARD INC. v. ANGIODYNAMICS, INC.

claimed, was not an inventive concept. BASCOM Global
Internet Servs., Inc. v. AT&T Mobility LLC, 827 F.3d 1341,
1347 (Fed. Cir. 2016). Even if the prior art asserted by An-
gioDynamics demonstrated that it would have been obvi-
ous to combine radiographic marking with the other claim
elements, that evidence does not establish that radio-
graphic marking was routine and conventional under Alice
step two.
In concluding that the method claims were patent inel-
igible, the district court further relied on its conclusion that
the method claims contained no more than a recitation of
the standards of medical care required after the FDA
warned doctors about power injection through vascular ac-
cess ports. But while the FDA directed medical providers
to verify a port’s suitability for power injection before using
a port for that purpose, it did not require doing so via im-
aging of a radiographic marker. There is no evidence in the
record that such a step was routinely conducted in the prior
art.
We therefore hold that the asserted claims are not pa-
tent ineligible under § 101 because the claims in their en-
tireties are not solely directed to printed matter.
3. Anticipation
As explained in our discussion of the printed matter
doctrine, when evaluating the novelty and non-obviousness
of claims, we must assign no patentable weight to the non-
functional printed matter in the claims, which in this case
is the information that the claimed access ports are suita-
ble for injection at the claimed pressure and flow rate.
Here, Bard presented largely undisputed evidence that cer-
tain prior art ports, and the use of those ports, satisfied
most of the remaining elements of the asserted claims, in-
cluding power injectability and the presence of external
identifiers. However, there remained a factual dispute
over whether any of the prior art access ports contained a
“radiographic marker” or “radiographic feature” as
Case: 19-1756 Document: 72 Page: 21 Filed: 11/10/2020

C R BARD INC. v. ANGIODYNAMICS, INC. 21

required by the asserted claims. Although AngioDynamics
points to certain features of two prior art ports, the ATP
and Port-a-Cath, that may be detectable via x-ray, Bard
presented contrary evidence that these features were not
radiographically discernible and could not be used to dis-
tinguish or identify the device or its functionality. Appel-
lee’s Br. 34–35; J.A. 16217, 17945. This conflicting
evidence created a genuine dispute of material fact as to
the novelty of the asserted claims. Thus, the district court
erred to the extent it granted summary judgment of inva-
lidity based on anticipation under § 102.
CONCLUSION
Because there remained triable issues of fact as to the
infringement and validity of the asserted claims, the dis-
trict court erred in not permitting Bard to fully present its
case at trial. For the reasons discussed, we reverse-in-part
the district court’s judgment of invalidity as it pertains to
ineligibility under § 101, we vacate-in-part the court’s judg-
ment of invalidity as to all other grounds, we vacate the
judgment of non-infringement and no willful infringement,
and we remand the case for further proceedings consistent
with this opinion.
REVERSED-IN-PART, VACATED-IN-PART, AND
REMANDED
COSTS
Costs to Appellants.