Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-19-01756/USCOURTS-ca13-19-01756-0/pdf.json

Parties Involved:
AngioDynamics, Inc.
Appellee
Bard Peripheral Vascular, Inc.
Appellant
C R Bard Inc.
Appellant

Document Text:

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, Washington, DC, argued for plaintiffs-appellants. Also represented 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.

______________________

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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 summary judgment as to anticipation. Thus, we reverse-inpart 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, AngioDynamics, 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 patient’s veins on a regular basis without needing to start an 

intravenous line each time. Vascular access ports were traditionally 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, certain 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 

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of these reported cases, the FDA cautioned medical providers in 2004 and 2005 that they should not use vascular access 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 injection, 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 implanted. 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” typically performed at the start of a CT procedure. Other identifiers 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 patient or kept in the patient’s medical records (i.e. a keychain, 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 strategies for identifying a power injectable port. These applications 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 radiographic marker identifying the claimed port as power injectable. 

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The ’417 and ’460 patents claim “assemblies” and “systems” 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 access port perceivable following subcutaneous implantation 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 implantation of the access port, the second feature 

identifying the access port as suitable for accommodating 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 subcutaneously implanted access port, the third feature 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

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or other symbols, patterns, or characters, and that the extrinsic 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 access 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 procedure, comprising:

providing an access port including a cannula-impenetrable housing and a radiographic feature indicating 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 second 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 concerning the radiographic feature and external features that 

are analogous to those in the asserted dependent claims of 

the ’417 and ’460 patents.

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Not long after Bard obtained FDA approval for its PowerPort product, AngioDynamics sought and obtained FDA 

approval to market its own vascular access port products

as suitable for power injection. While its initial power injection 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 patent claims. AngioDynamics moved to dismiss the complaint 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 Bataillon concluded that factual disputes remained on all issues 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 information” limitations were entitled to patentable weight 

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under the printed matter doctrine.1 Judge Fallon determined that these limitations were not entitled to patentable weight because they were directed to the content of 

information that was not “functionally or structurally related” 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, AngioDynamics 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 product met the flow rate and pressure requirements of the asserted 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 questions of whether certain claim elements are directed to 

printed matter and whether such printed matter is functionally 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).

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the patents-in-suit and Bard had not shown that the opinions 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 decision. 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 AngioDynamics’s motion for JMOL of non-infringement and no willful 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 “sustain[ing] AngioDynamics’s oral motion for Judgment as a 

Matter of Law, as well as its motions for summary judgment under Federal Rule of Civil Procedure 56, on the 

grounds that the claims of the Asserted Patents are invalid, not patent-eligible, not infringed and not willfully infringed.” 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 Acumed 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 

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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 construction 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 performed all claim steps of the asserted method claims of the 

’478 patent. Bard, 382 F. Supp. 3d at 336–37. Bard challenges 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 requirement “implied” in the court’s construction of the “access port” terms as “structured for power injection,” this 

mistake did not undermine the factual basis of his infringement 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 withstanding the pressures and flow rates used during such injections. This testimony did not rest on any conclusion that 

the devices were intended for such use. 

The court erroneously relied on our statement in Wiener v. NEC Electronics, Inc. that an expert’s infringement 

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testimony did not “create a factual dispute” where his opinion “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 requirement, as construed on appeal, that certain claimed “columns” be located on the data matrix of the claimed memory 

chip. Id. Without an analysis of that essential requirement, 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 disregarded an infringement expert’s testimony that relied on 

an incorrect understanding of the claim construction because the expert’s erroneously broad interpretation ignored 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 suggests that this caused him to disregard the requirements of 

the asserted claims under the correct construction. Although 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. AngioDynamics’s statements regarding the capabilities of its 

own product constituted substantial evidence of those capabilities. See FED. R. EVID. 801(d)(2). The weight assigned to that evidence was a question for the jury. 

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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 circumstantial evidence in the record to support AngioDynamics’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 infringing way and instructs users to use the product in an infringing 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 required by the asserted method claims, were generally performed 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 perform each step of the claimed methods. J.A. 25540; 26660–

71, 26783–90, 26803–08, 26820–25. This constituted substantial 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. 

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B. Willful Infringement

The district court granted judgment of no willful infringement 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 patents-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 applications that issued as the patents-in-suit prior to their issuance. J.A. 25505, 25550, 25496. Bard also introduced 

evidence that AngioDynamics intentionally copied Bard’s 

CT radiographic marker based on market demand. Appellants’ 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) (discussing evidence of intentional copying of a competing 

product as sufficient to support a verdict of willful infringement). While the existence of an invalidity opinion is a relevant 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 opinions, only invalidity opinions were presented at trial. 

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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 judgment and JMOL that the patents were invalid and patent 

ineligible, without specifying the statutory grounds for invalidity. J.A. 1–4. At the time the motions were granted, 

however, AngioDynamics had not yet presented its invalidity 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 issue.” 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 decision 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 summary judgment of invalidity based on subject matter ineligibility, anticipation, and non-enablement. Because 

nothing in the district court’s decision references or discusses enablement, we review the court’s validity judgment 

only as to eligibility and anticipation, both of which implicate the printed matter doctrine. 

We conclude that although the asserted claims contain 

printed matter that is not functionally related to the remaining 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. 

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1. Printed Matter

This court and its predecessor have long recognized that 

certain “printed matter” falls outside the scope of patentable 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 outside 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 matter.”). While historically “printed matter” referred to claim

elements that literally encompassed “printed” material, 

the doctrine has evolved over time to guard against attempts 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 patenting such printed matter unless it is “functionally related” 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 informs people of the claimed information, or whether it instead 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 because 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 

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from the digits printed on a circular band in Gulack3—

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 Miller4—where the indicia made the cup useful for 

measuring partial recipes. Id. Based on analogous reasoning, we held in Praxair that there was a functional relationship 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 discontinuation 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 accommodating a pressure within the cavity of at least 35 psi,” or 

both. These elements are directed to the content of the information conveyed. 

The parties disagree, however, over whether this 

printed matter is functionally related to the power injectable 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 conclusion 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).

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functionality is sufficient to constitute new functionality 

for purposes of the printed matter doctrine would eviscerate our established case law that “simply adding new instructions 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 information 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 functionally 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 anticipated. 

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 issue are directed to a patent-ineligible concept,” such as an 

abstract idea. Id. at 218. To determine if the claim’s 

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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 “examine 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 application. Alice, 573 U.S. at 221 (quoting Mayo Collaborative 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 concept’ 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 matter doctrine lies in the requirements of subject matter eligibility 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 HuaiHung Kao, 639 F.3d 1057, 1072–74 (Fed. Cir. 2011)). Notably, 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 matter 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 

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

evaluated whether the printed matter elements were entitled 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 alleged 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-eligible 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 analyzing information of a specified content, then displaying the 

results, and not any particular assertedly inventive technology for performing those functions” are directed to an 

abstract idea); Digitech Image Techs., LLC v. Elecs. for Imaging, 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.

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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 injectable 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 information conveyed, but also on the means by which that 

information is conveyed. In particular, the claimed invention 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 because the marker allows the implanted device to be readily 

and reliably identified via x-ray, as used during CT imaging. 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 identified 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 radiographic marker, in the “ordered combination” of elements 

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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 AngioDynamics demonstrated that it would have been obvious to combine radiographic marking with the other claim 

elements, that evidence does not establish that radiographic marking was routine and conventional under Alice

step two. 

In concluding that the method claims were patent ineligible, 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 access 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 imaging 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 patent ineligible under § 101 because the claims in their entireties 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 nonfunctional printed matter in the claims, which in this case 

is the information that the claimed access ports are suitable for injection at the claimed pressure and flow rate. 

Here, Bard presented largely undisputed evidence that certain prior art ports, and the use of those ports, satisfied 

most of the remaining elements of the asserted claims, including 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 

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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 distinguish or identify the device or its functionality. Appellee’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 invalidity based on anticipation under § 102. 

CONCLUSION

Because there remained triable issues of fact as to the 

infringement and validity of the asserted claims, the district 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 judgment 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.

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