Court Opinion

ID: 4585172
Source: CourtListenerOpinion
Date Created: 2020-11-10 16:01:42.556032+00
Date Added: 2024-06-11T08:48:19.796120
License: Public Domain

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
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 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.
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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
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 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.
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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
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 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).
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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
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 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
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 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.
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 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.
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 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.
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 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.
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 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
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 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).
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 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
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 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
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 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.
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 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
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 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
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 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.