Case: 19-1756 Document: 72 Page: 1 Filed: 11/10/2020
`United States Court of Appeals
`for the Federal Circuit
`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-
` DANIELLE VINCENTI TULLY, Cadwalader, Wickersham
`& Taft LLP, New York, NY, argued for defendant-appellee.
`Also represented by JACLYN HALL, CHRISTOPHER A.


`Case: 19-1756 Document: 72 Page: 2 Filed: 11/10/2020
`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.
`A. The Technology, Patents, and Accused Products
`The appellants, C. R. Bard Inc. and Bard Peripheral
`Vascular, Inc. (collectively, “Bard”), and the appellee, An-
`gioDynamics, Inc., are manufacturers of vascular access
`ports, which are devices implanted underneath a patient’s
`skin that allow medical providers to inject fluid into the pa-
`tient’s veins on a regular basis without needing to start an
`intravenous line each time. Vascular access ports were tra-
`ditionally used to administer injections at a low pressure
`and flow rate. However, certain procedures, like computed
`tomography (“CT”) imaging, required injection of fluids
`into patients at a high pressure and high flow rate. This
`type of injection is referred to as “power injection.” As of
`2005, vascular access ports were not specifically approved
`by the FDA for use with power injection. Nonetheless, cer-
`tain medical providers were using existing ports for power
`injection, and in some cases, the pressure of the injection
`ruptured the port, seriously injuring the patient. In light


`Case: 19-1756 Document: 72 Page: 3 Filed: 11/10/2020
`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
`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-


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


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


`Case: 19-1756 Document: 72 Page: 6 Filed: 11/10/2020
`Not long after Bard obtained FDA approval for its Pow-
`erPort product, AngioDynamics sought and obtained FDA
`approval to market its own vascular access port products
`as suitable for power injection. While its initial power in-
`jection product did not include any features intrinsic to the
`device that identified its functionality, the company added
`identifiers such as a scalloped shape and a radiographic
`“CT” marker to its later products for easier identification.
`These new products were sold under the brand names
`Smart Port CP, Smart Port LP, Smart Port mini, Xcela,
`Xcela Plus, and BioFlo.
`B. Procedural History
`Bard sued AngioDynamics in the District of Delaware,
`asserting that AngioDynamics’s power injectable vascular
`access port products infringed the ’417, ’460, and ’478 pa-
`tent claims. AngioDynamics moved to dismiss the com-
`plaint on the ground that all claims of the patents-in-suit
`were ineligible under § 101. The district court denied the
`motion as premature. C. R. Bard, Inc. v. Angiodynamics,
`Inc., 156 F. Supp. 3d 540, 554 (D. Del. 2016). The parties
`later cross-moved for summary judgment on the questions
`of patent eligibility, novelty, and enablement. Judge Ba-
`taillon concluded that factual disputes remained on all is-
`sues and denied the motions without prejudice. C R Bard,
`Inc. v. AngioDynamics Inc., No. 1:15CV218, 2018
`WL 3130622, at *12–13 (D. Del. June 26, 2018)
`In advance of trial, the court requested a report and
`recommendation from Magistrate Judge Fallon on certain
`remaining claim construction issues, including whether
`the “radiographic letters” and “visually perceptible infor-
`mation” limitations were entitled to patentable weight


`Case: 19-1756 Document: 72 Page: 7 Filed: 11/10/2020
`under the printed matter doctrine.1 Judge Fallon deter-
`mined that these limitations were not entitled to patenta-
`ble weight because they were directed to the content of
`information that was not “functionally or structurally re-
`lated” to the claimed ports. Bard Peripheral Vascular, Inc.
`v. AngioDynamics, Inc., No. CV 15-218-JFB-SRF, 2019
`WL 1996022, at *3–6 (D. Del. Feb. 11, 2019). The district
`court adopted the recommendation.
`The parties proceeded to trial. Bard presented its case
`on infringement, willfulness, and damages through live
`testimony from a named inventor, infringement expert
`Timothy Clark, M.D., and a damages expert, along with
`deposition testimony from AngioDynamics employees. At
`the close of Bard’s case-in-chief, AngioDynamics moved for
`judgment as a matter of law (“JMOL”) of non-infringement
`and no willfulness. In asserting non-infringement, An-
`gioDynamics argued that (1) Dr. Clark’s testimony could
`not create triable issues of fact because he had improperly
`interpreted the claims to require that the vascular access
`port be “intended” for use with power injection, contrary to
`the court’s claim construction; (2) Bard had not conducted
`any testing to establish that AngioDynamics’s Xcela prod-
`uct met the flow rate and pressure requirements of the as-
`serted claims; and (3) there was no direct evidence that a
`single entity directly infringed the ’478 patent’s method
`claims. AngioDynamics also argued there was insufficient
`evidence of willful infringement because AngioDynamics
`had obtained invalidity opinions from counsel regarding
`1 This followed our decision in Praxair that the ques-
`tions of whether certain claim elements are directed to
`printed matter and whether such printed matter is func-
`tionally related to other claim elements may properly be
`resolved during claim construction. Praxair Distrib., Inc.
`v. Mallinckrodt Hosp. Prods. IP Ltd., 890 F.3d 1024, 1033
`(Fed. Cir. 2018).


`Case: 19-1756 Document: 72 Page: 8 Filed: 11/10/2020
`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).
`We first address the court’s judgments on infringement
`and invalidity. Applying the law of the regional circuit—
`here, the Third Circuit—we review the district court’s
`grant of JMOL and summary judgment de novo. See Ac-
`umed v. Adv. Surgical Servs., 561 F.3d 199, 211 (3d Cir.
`2009); Facenda v. NFL Films, Inc., 542 F.3d 1007, 1013
`(3d Cir. 2008). A court may grant JMOL during a jury trial
`only when (1) a party has been fully heard on an issue and
`(2) the court finds that a reasonable jury would not have a


`Case: 19-1756 Document: 72 Page: 9 Filed: 11/10/2020
`legally sufficient evidentiary basis to find for the party on
`that issue. FED. R. CIV. P. 50. A court will grant summary
`judgment on a claim or defense when there is no genuine
`dispute as to any material fact and a party is entitled to
`judgment as a matter of law. FED. R. CIV. P. 56.
`A. Infringement
`The district court granted JMOL of non-infringement
`on each of the three grounds raised by AngioDynamics:
`(1) that Dr. Clark failed to apply the court’s claim construc-
`tion for the terms “vascular access port” and “access port”
`in rendering his opinion; (2) that Bard had not shown that
`the accused Xcela product met the flow rate requirements
`of the asserted claims because Bard had not tested the
`product and relied only on AngioDynamics’s statements to
`the FDA regarding the product’s capabilities; and (3) that
`Bard’s evidence had not shown that a single entity per-
`formed all claim steps of the asserted method claims of the
`’478 patent. Bard, 382 F. Supp. 3d at 336–37. Bard chal-
`lenges each of these grounds.
`We agree with Bard that the district court erred in
`granting JMOL. First, although Dr. Clark testified during
`cross-examination that he believed there was an intent re-
`quirement “implied” in the court’s construction of the “ac-
`cess port” terms as “structured for power injection,” this
`mistake did not undermine the factual basis of his infringe-
`ment opinion. J.A. 25565–67. There is no indication from
`the record that Dr. Clark relied on the intent aspect of his
`claim interpretation in reaching his infringement opinion.
`During his direct testimony, he testified that each of the
`accused ports were suitable for power injection based on
`evidence that they were structurally capable of withstand-
`ing the pressures and flow rates used during such injec-
`tions. This testimony did not rest on any conclusion that
`the devices were intended for such use.
`The court erroneously relied on our statement in Wie-
`ner v. NEC Electronics, Inc. that an expert’s infringement


`Case: 19-1756 Document: 72 Page: 10 Filed: 11/10/2020
`testimony did not “create a factual dispute” where his opin-
`ion “rest[ed] on an
`incorrect claim
`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.


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


`Case: 19-1756 Document: 72 Page: 12 Filed: 11/10/2020
`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
`Bard introduced evidence at trial that AngioDynamics’s
`Director of Intellectual Property was aware of the applica-
`tions that issued as the patents-in-suit prior to their issu-
`ance. J.A. 25505, 25550, 25496. Bard also introduced
`evidence that AngioDynamics intentionally copied Bard’s
`CT radiographic marker based on market demand. Appel-
`lants’ Br. 37–38. This is sufficient evidence to support a
`jury verdict of willfulness. See Eko Brands, LLC v. Adrian
`Rivera Maynez Enters., Inc., 946 F.3d 1367, 1377–79
`(Fed. Cir. 2020) (discussing list of facts a jury can properly
`consider in assessing willfulness); Polara Eng’g Inc. v.
`Campbell Co., 894 F.3d 1339, 1353–54 (Fed. Cir. 2018) (dis-
`cussing evidence of intentional copying of a competing
`product as sufficient to support a verdict of willful infringe-
`ment). While the existence of an invalidity opinion is a rel-
`evant factor in determining willfulness, it was not
`dispositive, and the question of whether AngioDynamics
`reasonably believed that the asserted claims were invalid
`was a question of fact for the jury. See Eko Brands,
`946 F.3d at 1379.
`2 While the district court stated that AngioDynamics
`had obtained both invalidity and non-infringement opin-
`ions, only invalidity opinions were presented at trial.


`Case: 19-1756 Document: 72 Page: 13 Filed: 11/10/2020
`C. Printed Matter and Invalidity
`We first clarify procedural aspects of the district court’s
`judgment before addressing the merits of validity. In its
`final order, the district court granted both summary judg-
`ment and JMOL that the patents were invalid and patent
`ineligible, without specifying the statutory grounds for in-
`validity. J.A. 1–4. At the time the motions were granted,
`however, AngioDynamics had not yet presented its invalid-
`ity case at trial and Bard had not had the opportunity to
`defend the validity of its asserted claims. The district
`court’s JMOL of invalidity was thus procedurally improper
`because Rule 50 provides that JMOL against a party is only
`appropriate once the party “has been fully heard on an is-
`sue.” FED. R. CIV. P. 50.
`For that reason, we consider the merits of the district
`court’s invalidity judgment only as to the grounds on which
`AngioDynamics moved for summary judgment, and only to
`the extent we can reasonably read the district court’s deci-
`sion as bearing on those grounds. In addressing the merits
`of those grounds, we consider the entirety of the evidence
`presented during summary judgment, not merely the facts
`presented at trial. Here, AngioDynamics moved for sum-
`mary judgment of invalidity based on subject matter ineli-
`gibility, anticipation, and non-enablement.
` Because
`nothing in the district court’s decision references or dis-
`cusses enablement, we review the court’s validity judgment
`only as to eligibility and anticipation, both of which impli-
`cate the printed matter doctrine.
`We conclude that although the asserted claims contain
`printed matter that is not functionally related to the re-
`maining elements of the claims, each claim as a whole is
`patent eligible because none are solely directed to the
`printed matter. We also conclude that when we assign no
`patentable weight to the claimed printed matter, material
`disputes of fact remain as to whether other elements of the
`claim are novel over the prior art.


`Case: 19-1756 Document: 72 Page: 14 Filed: 11/10/2020
`1. Printed Matter
`This court and its predecessor have long recognized that
`certain “printed matter” falls outside the scope of patenta-
`ble subject matter under U.S. patent law. See AstraZeneca
`LP v. Apotex, Inc., 633 F.3d 1042, 1064 (Fed. Cir. 2010)
`(“This court has generally found printed matter to fall out-
`side the scope of § 101.”); In re Chatfield, 545 F.2d 152, 157
`(CCPA 1976) (“Some inventions, however meritorious, do
`not constitute patentable subject matter, e.g., printed mat-
`ter.”). While historically “printed matter” referred to claim
`elements that literally encompassed “printed” material,
`the doctrine has evolved over time to guard against at-
`tempts to monopolize the conveyance of information using
`any medium. See Praxair Distrib., Inc. v. Mallinckrodt
`Hosp. Prods. IP Ltd., 890 F.3d 1024, 1032 (Fed. Cir. 2018);
`In re Distefano, 808 F.3d 845, 849 (Fed. Cir. 2015). Today,
`printed matter encompasses any information claimed for
`its communicative content, and the doctrine prohibits pa-
`tenting such printed matter unless it is “functionally re-
`lated” to its “substrate,” which encompasses the structural
`elements of the claimed invention. Praxair, 890 F.3d at
`1032; DiStefano, 808 F.3d at 848–49.
`In evaluating the existence of a functional relationship,
`we have considered whether the printed matter merely in-
`forms people of the claimed information, or whether it in-
`stead interacts with the other elements of the claim to
`create a new functionality in a claimed device or to cause a
`specific action in a claimed process. Thus, we held in In re
`Marco Guldenaar Holding B.V., that the markings on dice
`had no functional relationship to the dice themselves be-
`cause the markings did not cause the dice to become a
`“manufacture with new functionality.” 911 F.3d 1157,
`1161 (Fed. Cir. 2018). We distinguished the dice markings


`Case: 19-1756 Document: 72 Page: 15 Filed: 11/10/2020
`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).


`Case: 19-1756 Document: 72 Page: 16 Filed: 11/10/2020
`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-
`2. Subject Matter Eligibility
`To determine whether claimed subject matter is patent
`eligible, we apply the two-step framework set forth in Alice
`Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014).
`First, at step one, we “determine whether the claims at is-
`sue are directed to a patent-ineligible concept,” such as an
`abstract idea. Id. at 218. To determine if the claim’s


`Case: 19-1756 Document: 72 Page: 17 Filed: 11/10/2020
`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

This document is available on Docket Alarm but you must sign up to view it.

Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.


A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.

Access Government Site

We are redirecting you
to a mobile optimized page.

Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket