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.
`______________________
`
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`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.
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`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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`C R BARD INC. v. ANGIODYNAMICS, INC.
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`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.
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`5
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`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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`C R BARD INC. v. ANGIODYNAMICS, INC.
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`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.
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`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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`C R BARD INC. v. ANGIODYNAMICS, INC.
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`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.
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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 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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`C R BARD INC. v. ANGIODYNAMICS, INC.
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`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.
`is similarly distinguishable.
`Boston Scientific Corp.
`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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`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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`C R BARD INC. v. ANGIODYNAMICS, INC.
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`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. 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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`C R BARD INC. v. ANGIODYNAMICS, INC.
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`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.
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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 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
`
`In re Gulack, 703 F.2d 1381, 1382–83 (Fed. Cir.
`
`In re Miller, 418 F.2d 1392, 1393 (CCPA 1969).
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`3
`1983).
`4
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`C R BARD INC. v. ANGIODYNAMICS, INC.
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`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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`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 m