CR Bard v. Medical Components

Filing 715

MEMORANDUM DECISION AND ORDER granting in part and denying in part 463 Defendant's Motion for Partial Summary Judgment. Signed by Judge Robert J. Shelby on 7/22/21. (dla) (Additional attachment(s) added on 7/22/2021: # 1 Errata Corrected Memorandum Decision and Order Granting in Part Defendant's Motion for Partial Summary Judgment) (dla).

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IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF UTAH
C.R. BARD, INC., a New Jersey corporation,
and BARD PERIPHERAL VASCULAR,
INC., an Arizona corporation,

MEMORANDUM DECISION AND
ORDER GRANTING IN PART
DEFENDANT’S PARTIAL MOTION
FOR SUMMARY JUDGMENT

Plaintiffs,
2:12-cv-00032-RJS-DAO
v.
Chief District Judge Robert J. Shelby
MEDICAL COMPONENTS, INC., a
Pennsylvania corporation,

Magistrate Judge Daphne A. Oberg

Defendant.
In this patent infringement action, Plaintiffs C.R. Bard, Inc. and Bard Peripheral
Vascular, Inc. (collectively, Bard) assert three patents against Defendant Medical Components,
Inc. (MedComp). All three patents are directed to systems and methods for identifying a
vascular access port as suitable for power injection following implantation of the device in the
human body. Now before the court is MedComp’s Motion for Partial Summary Judgment on the
grounds of non-infringement and invalidity as to Bard’s patents-in-suit.1 For the reasons
explained below, MedComp’s Motion is GRANTED IN PART. The court defers consideration
of MedComp’s request for summary judgment on Bard’s alleged infringement of MedComp’s
asserted patent.
BACKGROUND
Bard and MedComp are medical device manufacturers who develop, produce, and market
various vascular access devices, including subcutaneous access ports. Access ports are devices

1

Dkt. 463. In its Motion for Partial Summary Judgment, MedComp, as Counterclaimant, asserts its own U.S. Patent
No. 8,021,324, seeking summary judgment against Bard for infringement. The court will not address MedComp’s
counterclaims in this Order.

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that are implanted within the body of a patient, providing a convenient method of repeatedly
delivering infusions of medicine, blood products, or other fluids into a patient’s veins without
requiring invasive surgical procedures or the need to start a new intravenous line on each
occasion.2 Power injection machines employing high pressure are sometimes used to deliver
highly viscous fluids through access ports at specific desired rates of flow.3 Unlike regular
access ports that can fracture and cause significant bodily injury or death if subjected to power
injection, special power injectable ports are designed to withstand high pressures.4
Generally, access ports offered by different manufacturers and different models exhibit
substantially similar geometries, making it difficult to differentiate between power injectable
ports and regular access ports once they have been implanted in the body.5 Due to reported cases
of injury, “the FDA cautioned medical providers in 2004 and 2005 that they should not use
vascular access ports for power injection unless the ports were specifically and identifiably
labeled for such use.”6 Access port manufacturers thus seek methods of adding identifiers to
their ports that enable identification of power-injectability following implantation.7 The various
iterations of port identification methods comprise the heart of the patent disputes between Bard
and MedComp.
Bard asserts three patents in this case: U.S. Patent Nos. 7,785,302 (the ’302 Patent),
7,947,022 (the ’022 Patent), and 7,959,615 (the ’615 Patent).8 The ’302 Patent is the “parent”

2

See Dkt. 585-2 (Bard’s Redacted Tutorial Exhibit) at 4.

3

See id. at 15–18.

4

See id. at 20, 23–24.

5

See id. at 26–27.

6

C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372, 1375 (Fed. Cir. 2020).

See Dkt. 585-2 at 29–33; see also Dkt. 579 (Disk with MedComp’s Technology Tutorial) at 26–30 (on file with
Clerk’s Office).
7

8

Dkt. 463 at 1, ¶ 1.
2

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patent, while the ’615 Patent is a continuation and the ’022 Patent is a continuation in part of the
’302 Patent.9 All three of the asserted patents are directed to systems and methods for venous
access port identification.10 The background and summary sections of the specifications in the
’302 and ’615 Patents are substantially similar,11 and the detailed description sections of the
specifications in the ’302 and ’022 Patents are also substantially similar.12 Each of the
independent and dependent claims in the ’302 and ’022 Patents require the presence of a type of
radiopaque marker identifying the claimed port as power injectable.13 And the claim at issue in
the ’615 Patent requires the presence of a structural feature identifying the claimed port as power
injectable.14
The ’302 and ’022 Patents claim access ports wherein at least one radiopaque identifier is
included in the port assembly, identifying the port as suitable for power injection. Regarding the
’302 Patent, Bard asserts independent claims 1, 5, 8, and 10, and dependent claims 3, 4, 6, and 7,
each dependent from either claim 1 or claim 5.15 From the ’022 Patent, Bard asserts independent
claims 1 and 10, and dependent claims 3, 5, 8, 9, 12, and 14, each dependent from either claim 1
or claim 10.16 Claim 1 of the ’302 Patent is illustrative of these claims:
1. A venous access port assembly for implantation into a patient comprising:
a housing having a discharge port, a needle-penetrable septum, and a cap securable to
the housing and retaining the septum securely in the assembly, the housing having a
Dkt. 534 (Bard’s Opposition to Partial Motion for Summary Judgment) at 7, ¶ 2. MedComp disputes that the ’615
Patent is properly characterized as a continuation of the ’302 Patent. See Dkt. 604 (MedComp’s Reply). The court
need not address this issue here as it is immaterial to the analysis at hand.
9

10

See Dkt. 457-1 (Joint Appendix), JA-38 at 1:1-2; JA-101 at 1:1-2; and JA 148 at 1:1-2.

11

See id. JA-38 at 1:13–2:24; JA-148 at 1:17–2:28.

12

See id. JA-39 at 3:23–4:24; JA-101 at 2:63–3:62.

13

See id. JA-43 at 12:56–14:21; JA-108 at 15:11–16:44.

14

See id. JA-154 at 13:23–14:9.

15

Dkt. 534 at 7, ¶ 3.

16

Id.
3

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housing base defining a bottom wall of at least one reservoir, and outwardly facing
bottom surface,
the housing base including radiopaque alphanumeric characters that convey to a
practitioner that the venous access port assembly is power injectable when an X-ray
of the patient is taken after implantation.17
The ’615 Patent claims access ports wherein at least one structural feature is included in
the port assembly, identifying the port as suitable for power injection. Bard asserts independent
claim 8 of the ’615 Patent:
8. An access port for providing subcutaneous access to a patient, comprising:
a body defining a cavity accessible by inserting a needle through a septum, the body
including a plurality of side surfaces and a bottom surface bounded by a bottom
perimeter, the bottom surface on a side of the port opposite the septum, the bottom
perimeter including a concave portion, the side surfaces including a first side surface
through which an outlet stem extends; and
at least one structural feature of the access port identifying the access port as being
power injectable subsequent to subcutaneous implantation, the at least one structural
feature comprising at least one concave side surface in a second side surface different
from the first side surface, the concave side surface extending to the bottom perimeter
concave portion.18
PROCEDURAL HISTORY
On January 11, 2012, Bard filed the above-captioned action against MedComp, alleging
infringement of the ’302, ’022, and ’615 Patents.19 At the same time, Bard also filed two similar
infringement cases against AngioDynamics and Smiths Medical in this court.20 These are known
as the Port I cases. On December 17, 2012, the Port I actions were stayed and administratively
closed while the patents-in-suit underwent inter partes reexamination before the United States

17

Dkt. 457-1, JA-43 at 12:57–67.

18

Id. JA-154 at 13:23–14:7.

19

Dkt. 115 at 2–3.

Dkt. 458 (Bard’s Opening Claim Construction Brief) at 1. The case against AngioDynamics involves the same
three Bard patents at issue in this case, and the case against Smiths involves two of the three patents. See id. at n.3.
20

4

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Patent and Trademark Office (USPTO).21 The stay remained in place for approximately seven
years until it was lifted on October 4, 2019.22 In November 2020, the AngioDynamics and
Smiths Medical cases were transferred to the District of Delaware, but the instant MedComp
action remained in Utah.23
In 2015, while the Port I actions were stayed, Bard filed a separate suit against
AngioDynamics in the District of Delaware (Port II), alleging infringement of Bard’s patents
from a separate port patent family.24 The patents at issue in Port II also claim strategies for
identifying a power injectable port, specifically through the presence of radiographic markers.25
On July 7, 2017, Bard filed a second infringement action against MedComp in the District of
Utah (Port III).26 That case, now pending before Judge Howard Nielson, involves Bard’s patents
from both the Port I and Port II patent families.27
Following the lifting of the stay in the Port I actions, this case has recommenced and
progressed as follows: fact discovery commenced on March 30, 2020 and closed on February 8,
2021; the parties completed claim construction briefing on April 2, 2021; summary judgment
briefing was completed on April 16, 2021; and the parties conducted a technology tutorial for the
court on April 28, 2021.28 After reviewing the claim construction briefs and cross-motions for

21

Id. at 3–4.

22

See Dkt. 161.

23

See Dkt. 458 at 1 n.3.

24

Id.

25

See AngioDynamics, 979 F.3d at 1375.

26

See Dkt. 458 at 1 n.3.

27

Id.

28

See Dkt. 539 (Bard’s Opposition to MedComp’s Motion to Consolidate Cases) at 2–3.
5

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summary judgment, the court finds issues concerning the invalidity of Bard’s patents-in-suit ripe
for review.
LEGAL STANDARD
Summary judgment is appropriate when “there is no genuine dispute as to any material
fact and the movant is entitled to judgment as a matter of law.”29 A dispute is genuine “if the
evidence is such that a reasonable jury could return a verdict for the nonmoving party.”30 A fact
is material if, under the governing substantive law, it could “affect the outcome of the suit.”31
When applying this standard, the court “view[s] the evidence and make[s] all reasonable
inferences in the light most favorable to the nonmoving party.”32
ANALYSIS
In its opening claim construction brief, MedComp argues that several of the claim terms
in Bard’s asserted patents are directed to printed matter and are, therefore, not entitled to
patentable weight under the printed matter doctrine.33 MedComp further argues that if the court
adopts MedComp’s proposed construction of the disputed terms and agrees the printed matter
doctrine applies, the asserted Bard patent claims fail to meet the subject matter eligibility
requirements of 35 U.S.C. § 101, rendering them invalid.34 Based on these arguments, the Court
will begin by analyzing whether the printed matter doctrine applies before turning to the
discussion of subject matter eligibility and invalidity.

29

Fed. R. Civ. P. 56(a).

30

Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).

Id.; see also United States v. Simons, 129 F.3d 1386, 1388 (10th Cir. 1997) (“The substantive law of the case
determines which facts are material.”).
31

32

N. Natural Gas Co. v. Nash Oil & Gas, Inc., 526 F.3d 626, 629 (10th Cir. 2008).

33

See Dkt. 459 (MedComp’s Opening Claim Construction Brief) at 11–17.

34

See Dkt. 463 at 10–22.
6

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I.

The Printed Matter Doctrine
The Federal Circuit has long held that certain “printed matter” falls outside the scope of

patentable subject matter as set forth in 35 U.S.C. § 101.35 Although early cases employing this
doctrine applied it to claims that literally encompassed “printed” materials, “the doctrine has
evolved over time to guard against attempts to monopolize the conveyance of information using
any medium.”36 Currently, the printed matter doctrine encompasses “any information claimed
for its communicative content.”37 Thus, any “claim limitations directed to the content of
information are not entitled to patentable weight because such information is not patent eligible
subject matter” under § 101.38
Although printed matter is generally patent ineligible, there is a recognized exception to
the rule: if a limitation claims printed matter that is “functionally related” to its “associated
physical substrate,” the printed matter is given patentable weight and may serve to distinguish
the new invention from the prior art.39 “The first step in the printed matter analysis is
determining whether the limitation in question is in fact directed toward printed matter.”40 In
other words, does the limitation in question claim the content of information? If so, “the next

See, e.g., AngioDynamics, 979 F.3d at 1381 (explaining that the Federal Circuit has “long recognized that certain
‘printed matter’ falls outside the scope of patentable subject matter under U.S. patent law”); AstraZeneca LP v.
Apotex, Inc., 633 F.3d 1042, 1064 (Fed. Cir. 2010) (“This court has generally found printed matter to fall outside the
scope of § 101”)).
35

36

AngioDynamics, 979 F.3d at 1381 (citing Praxair Distribution, Inc. v. Mallinckrodt Hosp. Prod. IP Ltd., 890 F.3d
1024, 1032 (Fed. Cir. 2018) (extending the printed matter doctrine to claim limitations reciting certain mental steps
or processes physicians take when prescribing a drug and finding the limitations were not entitled to patentable
weight); In re Distefano, 808 F.3d 845, 849–50 (Fed. Cir. 2015) (citing cases developing the printed matter doctrine
and providing examples of what qualifies as printed matter)).
37

Id. (citing Praxair, 890 F.3d at 1032; Distefano, 808 F.3d at 848–49).

38

Praxair, 890 F.3d at 1032.

39

Id.; see also AstraZenaca, 633 F.3d at 1064.

40

Distefano, 808 F.3d at 848.
7

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step is to ascertain whether the printed matter is functionally related to its ‘substrate.’”41 For
example, the Federal Circuit held in In re Gulack that although a sequence of printed digits on a
wristband was printed matter, the sequence was still entitled to patentable weight42 because “the
printed matter and the circularity of the band were interrelated, so as to produce a new product
useful for educational and recreational mathematical purposes.”43 In contrast, the Federal Circuit
found that the printed matter in AstraZeneca, which merely added an FDA-required instruction
sheet to a known drug product, was not sufficient to create a functional relationship and could
not be given patentable weight.44
Here, MedComp identifies three claim limitations that it argues are printed matter: (1)
“markings” (’302 Patent, claim 10), (2) “identification feature” (’022 Patent, claims 1, 3, 5, 8, 9,
and 10), and (3) “structural feature of the access port identifying the access port as being power
injectable” (’615 Patent, claim 8).45 With respect to the “identification feature” and “markings,”
MedComp asserts that these terms fall squarely within the printed matter doctrine because they
are “information conveyors” whose only purpose is to identify the port in question as capable of
power injection.46 Similarly, MedComp contends the “structural feature” described in the ’615
Patent, which comprises at least one concave side surface of the port in question, serves the
identical purpose of solely conveying information identifying the port as power injectable.47

41

Praxair, 890 F.3d at 1032.

42

See In re Gulack, 703 F.2d 1381, 1386–87 (Fed. Cir. 1983).

43

In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004) (distinguishing Gulack from the printed matter under
consideration in Ngai).
44

AstraZeneca, 633 F.3d at 1065.

45

See Dkt. 557 (Joint Claim Construction Chart) at 3–4.

46

See Dkt. 459 at 13–14.

47

See id. at 16.
8

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In response, Bard contends that because the claims at issue in the ’022 Patent require a
“radiopaque identification feature” and the claims at issue in the ’302 Patent require “radiopaque
markings,” the proposed claim limitations should be extended to include the terms “radiopaque
markings” (’302 Patent) and “radiopaque identification feature” (’022 Patent).48 Bard further
argues that MedComp’s proposed limitations “read the term ‘radiopaque’ completely out of the
claims and therefore cannot be right.”49 If the term “radiopaque” is included, Bard maintains the
claim limitations cannot be considered printed matter because the radiopacity of the
marker/identification feature is merely a structural element, which makes the marker observable
when viewed on X-ray, and does not specify the content of information.50 Rather, the
radiographic marker element “merely claims a technological way to convey information
subcutaneously.”51
Similarly, Bard argues the claim limitation concerning the ’615 Patent—the structural
feature identifying the port as being power injectable—is also not subject to the printed matter
doctrine because the claimed structural feature is not directed to the content of information.52 It
is merely the means of conveying the information, and “[t]he fact that it eventually is used for
identification does not make it any less of a structural feature.”53
Both parties’ arguments rely heavily on the Federal Circuit’s recent decision in the Port
II action, C R Bard v. AngioDynamics.54 In that case, the Federal Circuit considered three

48

See Dkt. 458 at 15, 17.

49

See Dkt. 531 (Bard’s Responsive Construction Brief) at 10.

50

Id. at 11.

51

Id. at 13.

52

Id. at 19.

53

Id.

54

979 F.3d 1372 (Fed. Cir. 2020).
9

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similar Bard patents claiming strategies for identifying a power injectable port.55 Each of the
asserted claims at issue “require[d] the presence of a radiographic marker identifying the claimed
port as power injectable.”56 The district court had considered the claim limitations “radiographic
letters” and “visually perceptible information,”57 holding “that the asserted claims were invalid
because they were directed to printed matter as ineligible subject matter and were not
inventive.”58 On appeal, the Federal Circuit agreed that the printed matter doctrine applied.59
Because the asserted claims contained printed matter that was not functionally related to the
remaining elements of the claims, the Federal Circuit found that the printed matter was not
entitled to patentable weight.60 However, upon continuing its analysis concerning the subject
matter eligibility of the claims under § 101, the Federal Circuit found that the asserted claims
retained patent eligibility because, when viewed as a whole, none of the claims were solely
directed to the printed matter.61
Here, the parties disagree about the scope and meaning of the Federal Circuit’s printed
matter analysis in the AngioDynamics decision. Bard asserts “the Federal Circuit gave
patentable weight to the radiopaque markers while separately holding that the content of the

55

Id. at 1375.

56

Id.

57

Prior to trial, the district court requested a report and recommendation from Magistrate Judge Fallon as to whether
the terms “radiographic letters” and “visually perceptible information” were entitled to patentable weight under the
printed matter doctrine. Judge Fallon found that the limitations were directed to the content of information and were
not “functionally or structurally related” to the claimed ports, meaning the terms could not be entitled to patentable
weight as they were printed matter. See Bard Peripheral Vascular, Inc. v. AngioDynamics, Inc., No. CV 15-218JFB-SRF, 2019 WL 1996022, at *3–6 (D. Del. Feb. 11, 2019). The district court adopted this recommendation.
AngioDynamics, 979 F.3d at 1376.
58

AngioDynamics, 979 F.3d at 1378 (citing C R Bard Inc. v. AngioDynamics Inc., 382 F. Supp. 3d 332, 337–41 (D.
Del. 2019)).
59

Id. at 1381–82.

60

Id.

61

Id. at 1381, 1383–84.
10

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information the markers conveyed was printed matter.”62 Bard supports this argument by
pointing to the Federal Circuit’s language from the case stating, “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.”63
MedComp disputes Bard’s characterization of the AngioDynamics decision, arguing that
even though the Federal Circuit afforded no patentable weight to an element of the claim, it went
on to examine the claims “as a whole” in order to determine whether the claimed subject matter
was patent eligible under § 101.64 Specifically, MedComp contends that the “proper analysis
[under the printed matter doctrine] is that the element that imparts information is not entitled to
patentable weight when the claim is viewed as a whole.”65 Based on this reading of
AngioDynamics, MedComp here contends that it is not “the abstract information imparted by the
element (i.e., that the ports are power injectable) that is denied patentable weight.” Rather, it is
“the element itself” (the radiopaque identifiers or the structural feature of the port) that should be
given no patentable weight.66 The claim should then be “evaluated as a whole to determine
whether there exists any new and unobvious functional relationship between the shape or
markings and the port.”67

62

Dkt. 531 at 11.

63

Dkt. 458 at 5 (quoting AngioDynamics, 979 F.3d at 1382). Bard also identifies a later statement from the Federal
Circuit’s Anticipation analysis, where the court stated, “[W]hen 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 suitable for injection at the claimed pressure and flow rate.” See id.
(quoting AngioDynamics, 979 F.3d at 1384).
64

Dkt. 527 at 5 (quoting AngioDynamics, 979 F.3d at 1381).

65

Id. (emphasis omitted).

66

Id. at 6 (emphasis omitted).

67

Id.
11

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Before engaging the two-step printed matter analysis, the court must first address two
preliminary questions presented by the parties’ disputes. First, should the word “radiopaque” be
included in the claim language at issue in the ’302 and ’022 Patents when considering the printed
matter doctrine? And second, is printed matter restricted solely to the content of the information
conveyed, or does it also encompass the medium used to convey the information? The court will
answer the questions in turn.
A. The Term “Radiopaque” Must be Included in the Claim Limitation Language at
Issue
As an initial matter, the court reiterates the current procedural posture of this case. The
parties completed claim construction briefing on April 2, 2021. If construction of some of the
proposed terms could be dispositive of the invalidity and/or infringement issues, Local Patent
Rule 6.2 also requires the parties to submit “any motion for partial summary judgment on that
issue . . . at the same time the moving party files its Cross-Motion for Claim Construction.”
Because MedComp asserts that certain of its proposed claim constructions, if adopted by the
Court, will render some of Bard’s asserted patent claims invalid, MedComp concurrently filed
the instant Motion for Partial Summary Judgment.
“Although the determination of patent eligibility requires a full understanding of the basic
character of the claimed subject matter, claim construction is not an inviolable prerequisite to a
validity determination under § 101.”68 When the “basic character of the claimed subject matter
in dispute . . . is clearly evident to the Court . . . no further construction of the claims is
required.”69 Here, it is clearly evident to the court that all of the ’302, ’022, and ’615 Patent

Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat. Ass’n, 776 F.3d 1343, 1349 (Fed. Cir. 2014)
(citations omitted).
68

Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat. Ass’n, No. 12-2501 MAS TJB, 2013 WL
3964909, at *5 (D.N.J. July 31, 2013), aff’d, 776 F.3d 1343 (Fed. Cir. 2014).
69

12

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claims at issue encapsulate the use of a feature—either a radiopaque marking/identifier or a
structural feature including at least one concave side surface—which serves the purpose of
conveying to a medical practitioner, subsequent to implantation, that the claimed access port is
suitable for power injection. As such, the relevant claim terms at issue here, according to
MedComp, are those that relate to the specific identification feature used in the claimed port:
“markings” (’302 Patent), (2) “identification feature” (’022 Patent), and (3) “structural feature of
the access port identifying the access port as being power injectable” (’615 Patent).
The court agrees with MedComp that these are the relevant terms to be considered.
However, the court also agrees with Bard that “it cannot be right” to read the term “radiopaque”
out of the proposed claim terms in the ’302 and ’022 Patents.70 All of the asserted claims at issue
in these two patents require a type of marking or identifier indicating that the claimed port is
power injectable—but not just any type of marking or identifier. It must be “radiopaque,”
meaning that the marker/identifier is observable when viewed on X-ray after the port has been
implanted in a patient’s body. No other type of identifier is mentioned in the claims, and it
would be erroneous for the court to omit the term “radiopaque” when construing these terms.
Therefore, the court holds that the claim terms at issue for the ’302 and ’022 Patents are
“radiopaque markings” and “radiopaque identification feature.”
Because the court has not engaged in formal claim construction, “the Court must adopt a
construction of the claims ‘most favorable to the patentee[.]’”71 Here, the court adopts Bard’s

70

Dkt. 531 at 10.

71

Content Extraction, 2013 WL 3964909, at *5 (citing Utramercial, Inc. v. Hulu, LLC, 722 F.3d 1335, 1339–40
(Fed. Cir. 2013), cert. granted, judgment vacated sub nom. WildTangent, Inc. v. Ultramercial, LLC, 573 U.S. 942
(2014) (vacated on other grounds) (“At summary judgment, the district court may choose to construe the claims in
accordance with this court’s precedent, or if not it may choose to give a construction most favorable to the patentee,
and to apply the usual rules pertaining to summary judgment from there, and still require clear and convincing
evidence of ineligible subject matter.”)).
13

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proposed constructions as provided in Bard’s Opening Claim Construction Brief: (1)
“radiopaque identification feature” is “[a] feature that is opaque when viewed on an x-ray”;72 (2)
“radiopaque markings” are “[m]arkings that are opaque when viewed on an x-ray”;73 and (3)
“structural feature of the access port identifying the access port as being power injectable” is a
“[s]tructural feature of the access port identifying that the claimed access port is power
injectable.”74 However, the court makes clear that it is not adopting, at this time, Bard’s
contention that the printed matter doctrine does not apply to these terms. Such a determination
requires further analysis.
As explained below, further claim construction is not required to resolve the portion of
MedComp’s Motion for Partial Summary Judgment directed to invalidity.
B. Printed Matter Encompasses the Medium Used to Convey Information
The roots of the printed matter doctrine date back to 1869 in Ex Parte Abraham, where
the court found that coupons with various kinds of stamps and figures were not patentable
subject matter.75 The doctrine continued to evolve until the modern rule became fully developed
in the 1931 case, In re Russell.76 There, the court considered the claimed invention, which
related to “improvements in indexes particularly to the indexing of names in directories,” and
held that “[t]he mere arrangement of printed matter on a sheet or sheets of paper . . . does not
constitute any new and useful art, machine, manufacture, or composition of matter, or any new
and useful improvement thereof . . . .” 77

72

Dkt. 531 at 10.

73

Id.

74

Id. at 17.

75

See Distefano, 808 F.3d at 849 (citing Ex Parte Abraham, 1869 C.D. 59 (Comm.Pat.1869)).

76

Id. (citing In re Russell, 18 C.C.P.A. 1184, 48 F.2d 668, 669) (1931)).

77

Id. (quoting Russell, 48 F.2d at 669).
14

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Since 1931, both the Federal Circuit and its predecessor court “have consistently limited
the printed matter rule to matter claimed for its communicative content.”78 After Russell, the
following matter has been found to be printed matter: markings on meat “arranged in a certain
manner for the purpose of identifying the meat,”79 an FDA label providing the dosage
instructions for using a medical product,80 a label instructing a patient to take a drug with food,81
instructions on how to perform a DNA test,82 numbers printed on a wristband,83 markings on
dice communicating whether a player has won or lost a wager,84 and the mental step requiring a
medical provider to weigh the benefit of treating neonatal patients with inhaled nitric oxide.85
Although this is not an exhaustive list, it is clear that “[t]he common thread amongst all of these
cases is that printed matter must be matter claimed for what it communicates.”86
Here, Bard argues the Federal Circuit in AngioDynamics “made clear that the radiopaque
markers themselves, as opposed to the identification information conveyed by the markers, are

78

Id. (emphasis added).

79

In re McKee, 20 C.C.P.A. 1018, 64 F.2d 379, 379–80 (1933).

80

See AstraZeneca, 633 F.3d at 1064–65.

King Pharms., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1279 (Fed. Cir. 2010) (“Although these ‘printed matter’
cases involved the addition of printed matter, such as written instructions, to a known product, we see no principled
reason for limiting their reasoning to that specific factual context. Rather, we believe that the rationale underlying
these cases extends to the situation presented in this case, wherein an instructional limitation is added to a method,
as opposed to a product, known in the art.”).
81

82

See In re Ngai, 367 F.3d 1336, 1338–39 (Fed. Cir. 2004).

83

See In re Gulack, 703 F.2d 1381, at 1384–85 (Fed. Cir. 1983) (holding that even though the claim included
printed matter, the printed matter was still entitled to patentable weight because there was a functional relationship
between the printed matter and its underlying substrate).
In re Marco Guldenaar Holding B.V., 911 F.3d 1157, 1161 (Fed. Cir. 2018) (“The markings on Appellant’s dice,
however, constitute printed matter, as pointed out by the Board, and this court has generally found printed matter to
fall outside the scope of § 101.”).
84

Praxair, 890 F.3d at 1033–34 (“Because claim limitations directed to mental steps may attempt to capture
informational content, they may be considered printed matter lacking patentable weight . . . .”).
85

86

Distefano, 808 F.3d at 850 (emphasis added).
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not printed matter.”87 Based on the Federal Circuit’s own printed matter doctrine precedent, the
court disagrees with this reading of the AngioDynamics decision.
As previously explained, “[t]he first step in the printed matter analysis is determining
whether the limitation in question is in fact directed toward printed matter.”88 The court must
examine whether the limitation claims the content of information. However, because the parties
in AngioDynamics agreed that the asserted claims included printed matter, the Federal Circuit’s
analysis at the first step was limited.89 The Federal Circuit explained that “[e]ach claim requires
one or more markers ‘identifying’ or ‘confirming’ that the implanted access port is ‘suitable’
either ‘for flowing fluid at a rate of at least 1 milliliter per second through the access port’ or ‘for
accommodating a pressure with the cavity of at least 35 psi,’ or both.”90 The court then went on
to confirm that “[t]hese elements are directed to the content of the information conveyed.”91 It is
unclear from this statement exactly which elements the Federal Circuit was referring to, nor is it
clear which specific claim limitation was being analyzed because the parties already conceded
that the claims included printed matter.
As this court sees it, the real disagreement over printed matter in AngioDynamics
occurred at the second step of the printed matter analysis. Bard argued that the printed matter in
the claims was functionally related to the power injectable port because the information
conveyed by the markers provided new functionality by making the port “self-identifying.”92
The Federal Circuit disagreed with Bard’s argument, citing past precedent and explaining that

87

Dkt. 458 at 5.

88

Distefano, 808 F.3d at 848.

89

See AngioDynamics, 979 F.3d at 1381.

90

Id. at 1382.

91

Id.

92

Id.
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“as early as the 1930s, our predecessor court recognized that the mere marking of products, such
as meat and wooden boards, with information concerning the product, does not create a
functional relationship between the printed information and the substrate.”93 Based on this
explanation and the Federal Circuit’s reliance on previous decisions regarding the printed matter
doctrine, this court disagrees with Bard’s assertion that the AngioDynamics decision stands for
the proposition that, when applying the printed matter doctrine, the content of the information
conveyed can be divorced from the medium used to convey the information.
Indeed, the first step of the printed matter analysis explicitly requires a court to determine
whether the claim limitation in question is directed to the content of information. The claim
limitation is the “matter claimed for its communicative content” and is therefore linked to the
content of the information because it is the medium through which the information is
conveyed.94 And as the Federal Circuit in AngioDynamics further explained, the matter claimed
for its communicative content is not strictly limited to “printed” material, but instead
encompasses “the conveyance of information using any medium.”95 Based on this reasoning, the
court holds that printed matter includes not only the information being conveyed but the matter
used to convey the information.
Although there are obvious similarities between AngioDynamics and the instant case, the
facts and procedural posture are different. Unlike in AngioDynamics, where Bard agreed the
claims included printed matter, here Bard insists that the asserted claim limitations are not

Id. (citations omitted) (emphasis added). The AngioDynamics court also explained that “[a] conclusion that mere
identification of a device’s own functionality for purposes of the printed matter doctrine would eviscerate our
established case law that ‘simply adding new instructions to a known product’ does not create a functional
relationship.” Id. (citing AstraZeneca, 633 F.3d at 1065 (citing Ngai, 367 F.3d at 1339)).
93

94

Distefano, 808 F.3d at 850 (emphasis added).

95

AngioDynamics, 979 F.3d at 1381.
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printed matter at all because the structures at issue, which convey information, are distinct from
the information conveyed.96 Having found that this argument is not supported by Federal Circuit
precedent, the court will now analyze whether the printed matter doctrine applies to this case.
C. The Asserted Claim Limitations Are Printed Matter
As previously explained, the court employs a two-step process to determine whether a
claim limitation in question is printed matter. “The first step in the printed matter analysis is
determining whether the limitation in question is in fact directed toward printed matter.”97
Federal Circuit cases “establish a necessary condition for falling into the category of printed
matter: a limitation is printed matter only if it claims the content of information.”98 If this
condition is met, “the next step is to ascertain whether the printed matter is functionally related
to its ‘substrate.’”99
Here, the claim limitations in question are “radiopaque markings” (’302 Patent),
“radiopaque identification feature” (’022 Patent), and “structural feature of the access port
identifying the access port as being power injectable” (’615 Patent). Both the radiopaque
markings and radiopaque identification feature, which are observable on X-ray following
subcutaneous implantation, convey to a medical practitioner that the access port is power
injectable.100 The ’615 Patent uses a “structural feature,” which includes at least one concave
side surface, allowing a medical practitioner to identify a power-injectable port after
implantation.

Dkt. 458 at 17. (“MedComp again improperly conflates the structure conveying information with the information
conveyed to advance its printed matter argument.”).
96

97

Distefano, 808 F.3d at 848.

98

Id.

99

Praxair, 890 F.3d at 1032.

100

See, e.g., Dkt. 457-1, JA-44 at 14:17–21; JA-108 at 15:16–21.
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Bard argues the radiopaque marking and identification feature elements are structural
elements that do not specify the content of information.101 They are simply “marker[s] that [are]
observable when viewed on X-ray and can be used to convey information about an implanted
access port.”102 But this statement from Bard’s Responsive Claim Construction Brief about the
ability of the markers to convey information generally is at odds with Bard’s argument in its
Opposition to MedComp’s summary judgment motion. There, Bard clarified that “Bard’s
patents claim power injectable access ports that are identifiable as such after implantation.”103
Specifically, “the ’302 and ’022 Patent claims require power injectable access ports with a
‘radiopaque alphanumeric message’ that is opaque to radiation, so it is visible on an x-ray and
indicates that the assembly is power injectable.”104
Bard makes a similar argument regarding the structural feature claimed in the ’615
Patent. Bard contends the structural feature is not directed to the content of information because
it is merely the means used to convey information, and it is improper for the court to read a
function into the structural element.105 Yet, in its Opposition to summary judgment, Bard itself
gives a function to the structural element, explaining that “[t]he ’615 Patent claims a power
injectable port with a structural feature—at least one concave side surface—that identifies the
port as power injectable.”106

101

See Dkt. 531 at 11.

102

Id.

103

Dkt. 534 at 2.

104

Id. at 35 (citing C.R. Bard v. AngioDynamics, Inc., 748 Fed. App’x. 1009, 1012) (Fed Cir. 2018) (internal
quotation marks omitted)).
105

Dkt. 531 at 19.

106

Dkt. 534 at 36 (emphasis added).
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Examining the claim language and reviewing Bard’s own statements, it is evident that the
claim limitations in question are directed to and claim the content of the information that a
subcutaneously implanted port is suitable for power injection. The fact that the identification
features at issue are a “technological way to convey information subcutaneously”107 does not
change this conclusion. Whether or not the limitations are technological structural features of
the access ports, their sole function is to convey the information that the port is power injectable.
Accordingly, the court finds that the claim limitations in question are printed matter.
Having so found, the court must proceed to the second step in the printed matter analysis
and determine whether the printed matter should nevertheless be given patentable weight. In
doing so, the court must “read the claim as a whole, considering each and every claim
limitation.”108 Printed matter is only given patentable weight “if the matter is functionally or
structurally related to the associated physical substrate[.]”109
Bard makes no argument that the radiopaque markers/identifiers and structural feature are
functionally related to the underlying power injection port. And MedComp’s argument against a
functional relationship relies on the Federal Circuit’s holding in AngioDynamics that “mere
identification of a device’s own functionality” is not “sufficient to constitute new functionality
for purposes of the printed matter doctrine.”110
Here, the court finds there is no functional relationship between the printed matter and
the underlying power-injectable access port upon which it is printed. The printed matter does not
change how the port works once it is implanted, it does not affect whether the port is capable of

107

Dkt. 531 at 13.

108

Distefano, 808 F.3d at 848.

109

Id. at 851.

110

Dkt. 459 at 15 (citing AngioDynamics, 979 F.3d at 1382).
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power injection, and it does not interrelate with the port to produce a new and useful product. In
other words, “the printed matter in no way depends on the [port], and the [port] does not depend
on the printed matter. All that the printed matter does is [add a subcutaneous identifier to] an
existing product.”111 For this reason, the court finds that the claim limitations in question are
printed matter not entitled to patentable weight.
This means the court must address MedComp’s argument that because the claim
limitations in question are printed matter, MedComp is entitled to summary judgment of
invalidity for all the asserted claims in which the limitations appear. The term “radiopaque
identification feature” appears in asserted independent claims 1 and 10, and asserted dependent
claims 3, 5, 8, and 9 of the ’022 Patent; the term “radiopaque markings” appears in asserted
independent claim 10 of the ’302 Patent; and the term “structural feature . . .” appears in asserted
independent claim 8 of the ’615 Patent. However, rather than limit the validity analysis to only
these claims, the court will expand its analysis to include all the remaining asserted independent
and dependent claims in the ’302 and ’022 Patents. These include asserted independent claims 1,
5, and 8, and asserted dependent claims 3, 4, 6, and 7 of the ’302 Patent, and asserted dependent
claims 12 and 14 of the ’022 Patent.
The reasons for the court’s inclusion of the remaining claims are manifold. In conducting
the printed matter analysis, the court naturally reviewed the specifications and all claim language
from the asserted patents. In doing so, it became clear to the court that all the asserted claims
contained limitations similar to the claim limitations the court has already found to be printed
matter. For example, within the ’302 Patent, independent claim 1 requires “radiopaque
alphanumeric characters that convey to a practitioner that the venous access port assembly is

111

Ngai, 367 F.3d at 1339.
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power injectable when an X-ray of the patient is taken after implantation”;112 independent claim
5 requires “a radiopaque alphanumeric message observable through interaction with X-rays . . .
and the alphanumeric message indicating that the assembly is power injectable;113 and
independent claim 8 requires “a radiopaque alphanumeric message . . . identifying the venous
access port assembly as suitable for power injection.”114 The various dependent claims in both
patents incorporate the port assembly described in the independent claims, including any
radiopaque markings/messages and merely specify where or how such markings/messages are
displayed.115
It is clear from the cited claim language that the radiopaque alphanumeric
characters/messages serve the same purpose as the radiopaque markings/identification features:
to convey to a medical practitioner, through a feature that is opaque to X-rays subsequent to
implantation, that the port in question is power injectable. Having already resolved the question
whether the printed matter doctrine applied to similar claim limitations, it would be illogical and
tremendously inefficient for the court to ignore the obvious presence of printed matter in the
other asserted claims. The radiopaque alphanumeric characters/messages in the remaining
asserted claims are similarly directed to the content of information with no functional
relationship to the underlying access port and constitute printed matter.
Moreover, the court is cognizant that, due to Local Patent Rules 4.1(b) and 6.2, the
parties were artificially constrained as to what they could argue at the summary judgment stage.

112

Dkt. 457-1, JA-44 at 12:64–67.

113

Id. at 13:14–18.

114

Id. at 14:5–10.

See id. at 13:3–7, 13:19–22; JA-108 at 16:13–14, 16:18–20. Although dependent claim 14 of the ’022 Patent
does not specify how or where the radiopaque identification feature is displayed, it incorporates the port assembly of
independent claim 10, which includes a radiopaque identification feature on the bottom surface of the port.
115

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Local Rule 4.1(b) restricts parties to no more than ten terms or phrases that may be presented to
the court for claim construction. If the parties cannot agree on ten terms, as here, then five terms
are allocated to the plaintiff and five to the defendant.116 The parties must then decide how to
allocate their five terms to address the most significant arguments and issues from their
prospective. And under LPR 6.2, “[w]henever construction of a term may be dispositive of an
issue, any motion for partial summary judgment must be filed at the same time the moving party
files its Cross-Motion for Claim Construction.” On its face, LPR 6.2 contemplates summary
judgment based on the limited number of construed terms offered by the parties. Yet because the
parties do not have the benefit of the court’s construction of the proposed terms at this stage, they
are required to file their motions for summary judgment without knowing how to precisely tailor
their arguments. Here, the Local Patent Rules effectively prevented the parties from making
more complete printed matter doctrine arguments.
Although the parties have not briefed the question of printed matter in all the asserted
claims, the court finds that it is not necessary for them to do so as the arguments at issue will be
identical to those already briefed by the parties. To conserve time and judicial resources,117 the
court holds that the printed matter doctrine applies to all the asserted claims in the ’302, ’022,
and ’615 Patents and will include them all in the following invalidity analysis.
II.

Subject Matter Eligibility
The Patent Act, under 35 U.S.C. § 101, defines patent-eligible subject matter as “any new

and useful process, machine, manufacture, or composition of matter, or any new and useful

116

See LPR 4.1(b).

See I/P Engine, Inc. v. AOL Inc., 576 F. App’x 982, 996 (Fed. Cir. 2014) (Mayer, J., concurring) (“From a
practical perspective, there are clear advantages to addressing section 101’s requirements at the outset of litigation.
Patent eligibility issues can often be resolved without lengthy claim construction, and an early determination that the
subject matter of asserted claims is patent ineligible can spare both litigants and courts years of needless litigation.”).
117

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improvement thereof.” However, the Supreme Court has “long held that this provision contains
an important implicit exception: Laws of nature, natural phenomena, and abstract ideas are not
patentable.”118 The Federal Circuit has confirmed that “where printed matter, irrespective of the
material upon which it is printed, is the sole feature of alleged novelty, it does not come within
the purview of [§ 101], as it is merely an abstract idea, and, as such, not patentable.”119
Courts must “tread carefully” when considering whether a § 101 exception to
patentability applies because “[a]t some level, ‘all inventions . . . embody, use, reflect, rest upon,
or apply laws of nature, natural phenomena, or abstract ideas.’”120 Therefore, “an invention is
not rendered ineligible for patent simply because it involves an abstract concept.”121 Such
concepts remain eligible for patent protection if their application is directed “to a new and useful
end.”122 To distinguish patents that claim abstract ideas from those that claim patent-eligible
applications of those ideas, the Supreme Court has set forth a two-step framework for
determining subject matter eligibility under § 101. This is known as the Alice inquiry.123 At
Alice step one, a court must decide whether the claims at issue, in their entirety, are directed to
ineligible subject matter, such as an abstract idea.124 “If not, the inquiry ends.”125 But if the
claims are directed to an abstract idea, the court must then analyze the claims—both individually

Alice Corp. Pry. V. CLS Bank Int’l, 573 U.S. 208, 216 (2014) (quoting Ass’n for Molecular Pathology v. Myriad
Genetics, Inc., 569 U.S. 576, 589 (2013)).
118

119

See AngioDynamics, 979 F.3d at 1383 (citing In re McKee, 75 F.2d 991, 992 (C.C.P.A 1935)).

120

Alice, 573 U.S. at 217 (quoting Mayo Collaborative Servs. v. Prometheus Lab’ys, Inc., 566 U.S. 66, 71 (2012)).

121

Id.

122

Id. (internal quotation marks and citation omitted).

The framework was first established in Mayo, but it was in Alice where the Supreme Court distilled Mayo’s
analysis into a distinct two-step process. See Alice, 573 U.S. at 217 (discussing Mayo, 566 U.S. at 77–82).
123

124

See Secured Mail Sols. LLC v. Universal Wilde, Inc., 873 F.3d 905, 909 (Fed. Cir. 2017) (citing Alice, 573 U.S.
at 217).
125

Id. (citations omitted).
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and as an “ordered combination”—under Alice step two to determine whether they contain an
“inventive concept” sufficient to “transform the nature of the claim into a patent-eligible
application.”126
Although the printed matter doctrine’s “underlying rationale is in subject matter
eligibility” under § 101, courts have typically applied the doctrine “in analyzing other
patentability requirements, including novelty under 35 U.S.C. § 102 and nonobviousness under
35 U.S.C. § 103.”127 However, in AngioDynamics, the Federal Circuit confirmed that “a patent
claim as a whole can be deemed patent ineligible” when a court analyzes a claim containing
printed matter under the Alice inquiry.128 But before a court may proceed to the Alice
framework, the Federal Circuit added a preliminary inquiry for claims involving printed matter:
“a claim may be found patent ineligible under § 101 on the grounds that it is [1] directed solely
to non-functional printed matter and [2] the claim contains no additional inventive concept.”129
Following this directive, the court will now analyze the claims at issue here under what the court
will refer to as the AngioDynamics framework.
A. The Claims at Issue are Directed Solely to Non-Functional Printed Matter and
Contain No Additional Inventive Concept
The nearly identical specification language in the background section of the ’302 and
’615 Patents describes the purpose of conventional access ports—that they “provide a convenient
method to repeatedly deliver a substance to remote areas of the body without utilizing surgical
procedures”130—and their typical construction—a housing assembly, a septum, a reservoir, and

126

See Alice, 573 U.S. at 217–18.

127

Praxair, 890 F.3d at 1032 (citations omitted); see also AngioDynamics, 979 F.3d at 1383.

128

AngioDynamics, 979 F.3d at 1383.

129

Id.

130

Dkt 457-1, JA-38 at 1:13–15; JA-148 at 1:17–19.
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an outlet of the housing that communicates with a catheter which access a vein.131 The
specifications go on to explain that “once an access port is implanted, it may be difficult to
determine the model, style, or design of the access port.”132 Therefore, “it would be
advantageous to provide an access port which provides at least one identifiable characteristic that
may be sensed or otherwise determined subsequent to subcutaneous implantation of the access
port.”133 Likewise, the specification language of the ’022 Patent also “relates to an access port
having at least one perceivable or identifiable feature for identifying the access port, wherein the
identifiable feature is perceivable after the access port is implanted within a patient.”134 It is
clear from this language that the sole motivation of the patents at issue is providing some type of
identifiable feature that communicates information about the underlying access port.
Following this general language, the claim language in each of the asserted patents then
goes on the recite with specificity the exact type of identifiable feature and the exact information
being communicated about the port in question. All the claims at issue in the ’302 and ’022
Patents require a type of radiopaque identifier conveying to a medical practitioner that the
implanted port is power injectable. And the claim at issue in the ’615 Patent requires a structural
feature with at least one concave side, which also conveys that the implanted port is suitable for
power injection.
When each claim is read as a whole, the focus of the claimed advance is using the abovenamed identifying features, in conjunction with an already known and typically constructed
access port, to convey the information that the access port is power injectable. Bard disputes that

131

See id. JA-38 at 1:20–24; JA-148 at 1:24–28.

132

Id. JA-38 at 1:48–50; JA-148 at 1:52–54.

133

Id. JA-38 at 1:54–57; JA-148 at 1:58–61.

134

Id. JA-102 at 3:31–34.
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the ports described in the asserted claims are typical or use conventional features, contending
that each of the claims require a power injectable port, which was not a conventional feature as
of the priority date of Bard’s patents.135 This argument is unpersuasive.
The various asserted claim language merely describes venous access port assemblies,
including a housing or body with an outlet, a needle-penetrable septum, and a reservoir or cavity.
There is nothing in the language of any of the asserted claims to specify what about these
conventional features makes them capable of power injection. Bard’s argument attempts to shift
the focus away from the stated purpose of the asserted claims—identifying power-injectable
ports subsequent to implantation—to the purported novelty of power-injectable ports. The court
will not countenance this argument.
At the core of each of the asserted claims at issue here is the basic idea of using a specific
type of identifier to convey information that a port is capable of power injection. The addition of
merely novel yet nonfunctional printed matter identifiers does not change the fact that the focus
of the claimed advance is solely on the content of the information conveyed. Any novelty in the
implementation of this idea, through radiopaque features or concave surfaces, “is a factor to be
considered only in the second step of the Alice analysis.”136 If the court were to find otherwise, it
would undermine the rationale underlying the printed matter doctrine, which “guard[s] against

135

See Dkt. 534 at 6.

136

Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014).
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attempts to monopolize the conveyance of information using any medium.”137 Accordingly, the
court holds that the claims at issue are directed solely to non-functional printed matter. 138
At the second step of the AngioDynamics framework, the court finds that the claims at
issue contain no additional inventive concept beyond the claimed printed matter. As explained
above, all the asserted claims recite only the assembly of a typical venous access port, including
the conventional and known features described in the specification, coupled with a printed matter
identifier conveying that the port is power injectable. Beyond the printed matter, there are no
other elements that could be considered “inventive.”
Having found that the claims at issue are directed solely to non-functional printed matter
and contain no additional inventive concept, the court will proceed to the two-step Alice inquiry.
Before doing so, however, the court must address Bard’s argument that if the court were to find
the identifiers at issue are printed matter, then the court cannot consider them in its validity
analysis.139 The court disagrees. When a court finds that a claim contains printed matter, it
simply means that the printed matter is not given any patentable weight and may not be a basis
for distinguishing prior art.140 This is a concern when conducting § 102 novelty or § 103
AngioDynamics, 979 F.3d at 1381; see also King, 616 F.3d at 1279 (“The rationale behind this line of [printed
matter doctrine] cases is preventing the indefinite patenting of known products by the simple inclusion of novel, yet
functionally unrelated limitations.”); Ngai, 367 F.3d 1336, 1339 (explaining that the court will not allow a party to
continue patenting a product indefinitely simply because the party added a new instruction sheet to the already
known product).
137

138

The court recognizes that Federal Circuit decisions in the realm of patent law are binding authority, and the
AngioDynamics decision is no exception to this rule. The court is also cognizant that this holding may appear in
tension with the Federal Circuit’s holding in AngioDynamics concerning whether similar claims are directed solely
to printed matter. Crucially, the evidence and arguments before this court differ substantially from the evidence and
arguments presented in AngioDynamics. Moreover, the Federal Circuit’s decision in AngioDynamics provides this
court and these parties the benefit of a clear framework for evaluating these issues that was not available to the trial
court or the parties in AngioDynamics prior to the Federal Circuit’s decision. At least in this court’s view, the
significant differences between the records compel a different result.
139

See Dkt. 531 at 12. Bard argues that the Federal Circuit found the radiopaque markers in AngioDynamics were
not printed matter because, otherwise, “they would not be entitled to patentable weight, and the Federal Circuit
would not have considered them in its validity analysis.”
140

See Distefano, 808 F.3d at 848.
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nonobviousness analyses. But determining whether a claim is directed to patent eligible subject
matter under § 101 is a different matter. A validity analysis concerning whether a claim is
directed to statutory subject matter is a “threshold test”141 that “must precede the determination
of whether that discovery is, in fact, new or obvious.”142 As such, “[t]he novelty and
nonobviousness of the claims under §§ 102 and 103 does [sic] not bear on whether the claims are
directed to patent-eligible subject matter under § 101.”143 The court must therefore look to the
claim language in its entirety, including the printed matter, when conducting a validity
analysis.144
B. The Alice Inquiry
“The validity of asserted claims under § 101 is a ‘threshold inquiry’ for the court to
decide as a matter of law.”145 As previously explained, when determining subject matter
eligibility under § 101, courts must follow the two-step framework established by the Supreme
Court in Alice. “[A] claim falls outside § 101 where (1) it is directed to a patent-ineligible
concept, i.e., a law of nature, natural phenomena, or abstract idea, and (2), if so, the particular
elements of the claim, considered both individually and as an ordered combination, do not add
enough to transform the nature of the claim into a patent eligible application.”146 The first step
of the inquiry examines “the focus of the claims, their character as a whole,” and the second step

141

Bilski v. Kappos, 561 U.S. 593, 602 (2010) (“The § 101 patent-eligibility inquiry is only a threshold test.”).

142

Parker v. Flook, 437 U.S. 584, 593 (1978).

Two-Way Media Ltd. v. Comcast Cable Commc’ns, LLC, No. CV 14-1006-RGA, 2016 WL 4373698, at *4 (D.
Del. Aug. 15, 2016), aff’d, 874 F.3d 1329 (Fed. Cir. 2017).
143

See Two-Way Media Ltd. v. Comcast Cable Commc’ns, LLC, 874 F.3d 1329, 1337 (Fed. Cir. 2017) (“Under
Alice step one, the claims are considered in their entirety to ascertain whether their character as a whole is directed
to excluded subject matter.”) (internal quotation marks and citation omitted)).
144

145

Two-Way Media, 2016 WL 4373698, at *3.

146

Elec. Power Grp., LLC v. Alston S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (citing Alice, 573 U.S. at 217–18)
(internal quotation marks omitted).
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looks “more precisely at what the claim elements add—specifically, whether . . . they identify an
inventive concept in the application of the ineligible matter to which (by assumption at stage
two) the claim is directed.”147
1. Alice Step One
Under Alice step one, the court must “consider the claims in their entirety to ascertain
whether they are directed to patent eligible subject matter.”148 Here, all the asserted claims are
directed to using a specific identifier—either a radiopaque identifier or a structural element
including at least one concave side—to communicate information to a medical practitioner that
the access port in question is power injectable subsequent to implantation.
This case is similar to the Federal Circuit’s recent decision in Secured Mail. There, the
Court analyzed multiple patents involving “methods whereby a sender affixes an identifier, [an
Intelligent Mail Barcode, a QR code, or a Personalized URL], on the outer surface of a mail
object . . . before the mail object is sent.”149 Once the object is mailed, “[c]omputers and
networks are used to communicate the information about the mail object’s contents and its
sender after the mail object is delivered.”150 The Court observed the claims were “not directed to
an improvement in computer functionality,” nor were they “directed to a new barcode format
[or] an improved method of generating or scanning barcodes.”151 There was also “no description
of how the unique identifier was generated.”152 The Federal Circuit ultimately concluded the

147

Id. (internal quotation marks and citations omitted).

148

Secured Mail, 873 F.3d at 909.

149

Id. at 907.

150

Id.

151

Id. at 910.

152

Id.
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methods asserted in the claim language were directed solely “to the abstract process of
communicating information about a mail object using a personalized marking.”153
The same is true here. All the asserted claim language from the three patents at issue
requires an identification feature that is incorporated into the underlying access port, which then
communicates information about the port’s capability to withstand power injection. The claims
are not directed to an improvement in port technology—the port will function in exactly the
same manner whether the identifier is present or not—and there is no description in the claim
language describing how the radiopaque identifiers or concave side surfaces are generated. The
claims are also void of any discussion of the X-ray technology used to view the radiopaque
identifiers after implantation of the port, meaning the claims are not directed to determining if
certain radiopaque identifiers or their placement on the port improves their visibility when
subject to X-ray.
The specification language in the ’302 and ’615 Patents alludes to the difficulty of
determining the model of the access port once it has been implanted and states that “such
uncertainty may be undesirable, at least for replacement timing purposes, among other
reasons.”154 The specification then goes on to explain that “it would be advantageous to provide
an access port” with “at least one identifiable characteristic” that may be sensed or determined
following implantation of the port.155 But this is not enough to render the subject matter of the
asserted claims patent eligible. Not only is this problem-solving language not included in any of

153

Id. at 911.

154

See Dkt. 457-1, JA-38 at 1:48–51; JA-148 at 1:52–55.

155

Id. JA-38 at 1:54–57; JA-148 at 1:58–61.
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the asserted claims, but the Federal Circuit has also clarified that “[t]he fact that an identifier can
make a process more efficient . . . does not necessarily render an abstract idea less abstract.”156
The Federal Circuit explicitly held in Secured Mail that the process of communicating
information using a marking or identifier that does not functionally improve any aspect of the
underlying object or identification process is an abstract idea not directed to patent eligible
subject matter.157 Because each asserted claim at issue here requires the use of an identifier to
communicate information about the power injectability of the underlying port and provides no
functional improvement to the port itself or the X-ray technology used to view the radiopaque
identifiers, the court finds the claims are directed to an abstract idea.
2. Alice Step Two
At Alice step two, a court must “consider the elements of each claim both individually
and ‘as an ordered combination’ to determine whether the additional elements ‘transform the
nature of the claim’ into a patent eligible application.”158 The second step of the Alice inquiry “is
satisfied when the claim limitations involve more than performance of well-understood, routine,
and conventional activities previously known in the industry.”159 “[W]hether a claim recites
patent eligible subject matter is a question of law which may contain underlying facts.”160
Determining whether a claim element “is well-understood, routine, and conventional to a skilled

156

Secured Mail, 873 F.3d at 910.

157

Id. at 910–11.

158

Alice, 573 U.S. at 217 (quoting Mayo, 566 U.S. at 78–79); see also Electric Power, 830 F.3d at 1354 (explaining
that under Alice step two, a court must scrutinize the claim elements “microscopically” to determine whether there is
anything in the claims to render their subject matter patent eligible).
159

Berkheimer v. HP Inc., 881 F.3d 1360, 1367 (Fed. Cir. 2018) (internal quotation marks, internal alteration, and
citations omitted).
160

Id. at 1368.
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artisan in the relevant field is a question of fact.”161 “Any fact . . . that is pertinent to the
invalidity conclusion must be proven by clear and convincing evidence.”162
The court will begin the Alice step two analysis by scrutinizing the asserted claims in the
’302 and ’022 Patents before turning to the single asserted claim in the ’615 Patent.
a. The Asserted Claims in the ’302 and ’022 Patents Do Not Contain an
Inventive Concept
The specification for the ’302 Patent explains that “the instant disclosure relates to an
access port having at least one perceivable or identifiable feature for identifying the access port,
wherein the identifiable feature is perceivable after the access port is implanted within a
patient.”163 One example of the “information of interest” communicated by the identifiable
feature is that the “access port may be correlative with the access port being power injectable.”164
The specification then describes one embodiment of an access port, in which “at least one
identifiable feature may be perceived via x-ray or ultrasound imaging.”165 Likewise, the
specification for the ’022 Patent contains nearly identical language166 and also teaches an
embodiment where “at least one identifiable feature may be perceived via x-ray or ultrasound
imaging.”167
“The improvements in the specification, to the extent they are captured in the claims,
create a factual dispute regarding whether the invention describes well-understood, routine, and

161

Id.

162

Id.

163

Dkt. 457-1, JA-39 at 3:60–64.

164

Id. at 4:5–10.

165

Id. at 4:20–21.

166

See Dkt. 457-1, JA-102 at 3:31–34, 42–44.

167

Id. at 3:58–59.
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conventional activities.”168 The court must therefore analyze the asserted claims “more
microscopically”169 to determine whether they capture the stated improvements.170
Here, the parties do not dispute that the alleged improvements to port identification are
captured in the asserted claims. Indeed, it is clear from the claim language that each independent
and dependent claim at issue requires the inclusion of some type of radiopaque identifier,
perceivable via x-ray, conveying to a medical practitioner the information that the access port is
power injectable. What the parties dispute is whether use of radiopaque identifiers “on
implantable medical devices” was “well-understood, routine and conventional at the relevant
time[.]”171
MedComp provides numerous pieces of evidence supporting its argument that radiopaque
identifiers were well-understood, routine, and conventional to those skilled in the art of
implantable medical devices. To begin, MedComp contends the “conventionality of radiopaque
marking” can be found in Bard’s own representations.172 In an affidavit filed with the USPTO
during the prosecution of the ’302 Patent, a former Bard project engineer in the vascular access
product area represented “that placement of a radiopaque marking on the surface of a port
housing base was ‘obvious to a person of ordinary skill in the art’ and ‘would have only involved
ordinary creativity on behalf of the designer.’”173
Additionally, MedComp points to a 2001 news bulletin in Medical Industry Week, where
Bard promoted the availability of its self-expanding nitinol biliary stent, which included

168

Berkheimer, 881 F.3d at 1369.

169

Electric Power, 830 F.3d at 1354.

170

Berkheimer, 881 F.3d at 1369.

171

See Dkt. 463 at 15.

172

Id.

173

Id. at 15–16 (citing APP-08081 at ¶ 27).
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radiopaque marker technology to allow for better visualization following placement of the stent
within a patient.174 MedComp argues that Bard’s representations before the USPTO, along with
Bard’s statements to the press, support a finding that use of radiopaque identifiers is not an
inventive concept unique to Bard’s access port technology.175
Beyond Bard’s own representations, MedComp also cites several articles from medical
journals and industry publications discussing the use of radiographic marking on implantable
medical devices years before Bard’s asserted patents were issued. Specifically, the articles
discuss the use of radiopaque identifiers to permit identification of implantable defibrillators,
provide easy tracking and precise positioning of implantable stents, and allow for the detection
of stray surgical swabs and sponges in post-operative patients.176 According to MedComp, this
evidence is incontrovertible proof “that the use of radiographic marking on implantable medical
devices was routine and conventional at the time of the asserted Bard patents.”177
In response, Bard points to the Federal Circuit’s AngioDynamics decision in Port II to
argue that MedComp’s purported evidence “is insufficient to establish lack of inventive concept
at Alice step two.”178 In AngioDynamics, the Federal Circuit found that the claims at issue in
Port II were not solely directed to non-functional printed matter, and thus were not directed to
patent ineligible subject matter under Alice step one.179 However, the Federal Circuit explained
that even if it “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

174

Id. at 16 (citing APP-037).

175

Id.

176

See id. at 17–18.

177

Id. at 18.

178

Dkt. 534 at 38.

179

AngioDynamics, 979 F.3d at 1384.
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two, that the use of a radiographic marker, in the ‘ordered combination’ of elements claimed,
was not an inventive concept.”180
As previously explained, determining if a claim element “is well-understood, routine, and
conventional to a skilled artisan in the relevant field is a question of fact.”181 As this court reads
it, the Federal Circuit in AngioDynamics essentially reviewed and rejected, based on the record
there provided, the trial court’s factual finding that use of radiographic markings was routine and
conventional in the art at the relevant time. Both the trial court’s ruling and the Federal Circuit’s
evaluation were undoubtedly constrained by the evidence and arguments presented by the
parties. But this court does not have before it the same record AngioDynamics’s generated in
Port II. The evidence and arguments submitted here by MedComp are considerably different.
This court can only consider in the context of the arguments presented by the parties whether
MedComp’s evidence is sufficient to show that the use of radiopaque identifiers was wellunderstood, routine, and conventional at the time of the asserted Bard patents. The court
concludes the evidence establishes exactly that.
In reviewing MedComp’s evidence, it is clear that the application of radiopaque
identifiers to subcutaneous medical devices was well-understood, routine, and conventional
within the implantable medical device industry long before Bard decided to add the identifiers to
its power-injectable ports. Indeed, Bard was already utilizing the technology on its own
implantable stent products.182 And by its own admission in the Port III case pending before

180

Id.

181

Id.

182

See Dkt. 463 at 16.
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Judge Nielson in this court, “Bard did not invent radiopaque markings on subcutaneous medical
devices for identification by x-ray or other imaging.”183
When analyzing the asserted claims individually, the use of a radiopaque identifier to
convey information is not an inventive concept. Based on the evidence provided by MedComp,
radiopaque identifiers were routinely used as information conveyors throughout the implantable
medical device industry at the time of Bard’s asserted patents. And when scrutinizing the
asserted claims as an “ordered combination,” the court still cannot find an inventive concept that
transforms the claims into a patent-eligible application. Each of the claims begins with a typical
access port made up of conventional features and then incorporates a radiopaque identifier into
the port for the purpose of conveying its suitability for power injection. The addition of a nonfunctional radiopaque identifier to a known product is not an inventive concept. If the court
were to hold otherwise, any medical device manufacturer would be able to add a radiopaque
identifier to any commonly produced implantable medical product and—so long as they are the
first to the patent office—claim a monopoly over an established product. Accordingly, the court
finds that none of the asserted claims in the ’302 and ’022 Patents contain an inventive concept
under Alice step two.
b. The Asserted Claim in the ’615 Patent Does Not Contain an Inventive
Concept
Identically to the specification for the ’302 Patent, the specification for the ’615 Patent
explains that “the instant disclosure relates to an access port having at least one perceivable or
identifiable feature for identifying the access port, wherein the identifiable feature is perceivable

183

See Dkt. 593 (Memorandum Decision and Order Construing Disputed Claim Terms and Phrases) at 44, C.R.
Bard, Inc. et al. v. Medical Components, Inc., Case No. 2:17-cv-00754-HCN-DAO.
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after the access port is implanted within a patient.”184 The ’615 specification also teaches the
“information of interest” communicated by the identifiable feature is that the “access port may be
correlative with the access port being power injectable.”185 The specification then describes one
embodiment of an access port, in which “at least one identifiable feature may be perceived by
palpation (i.e., to examine by touch), by way of other physical interaction, or by visual
observation.”186 This embodiment allows a “person of interest” to “touch or feel the access port
through the skin to perceive at least one identifying characteristic thereof.”187
Similar to its argument regarding the radiopaque identifiers in the ’302 and ’022 Patents,
MedComp maintains here that the use of shape (referring to the required structural feature of one
concave side surface in the asserted claim) is routine and conventional in the medical device
field.188 Bard does not respond to this argument. Rather, Bard advances in relation to the ’615
Patent only an argument concerning Alice step one. Bard insists the focus of the claimed
advance in the ’615 Patent—a concave side that can be perceived by palpation after
implantation—is not directed solely to content of the information conveyed but also to the means
by which the information conveyed.189 Having already rejected this argument in its preliminary
inquiry to the Alice test, the court will not repeat here why that argument fails.
“When there is no genuine issue of material fact regarding whether the claim element or
claimed combination is well-understood, routine, conventional to a skilled artisan in the relevant

184

Dkt. 457-1, JA-149 at 3:62–65.

185

Id. at 4:6–12.

186

Id. at 4:17–19.

187

Id. at 4:19–22.

188

Dkt. 463 at 19.

189

Dkt. 534 at 36.
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field, this issue can be decided on summary judgment as a matter of law.”190 For the following
two reasons, the court finds that the asserted claim in the ’615 Patent does not contain an
inventive concept.
First, the Federal Circuit has explained that to save a patent at Alice step two, “an
inventive concept must be evident in the claims.”191 Here, Bard asserts only independent claim 8
of the ’615 Patent. The claim language begins by describing the conventional features
comprising the access port assembly, and then continues by requiring:
at least one structural feature of the access port identifying the access port as
being power injectable subsequent to subcutaneous implantation, the at least one
structural feature comprising at least one concave side surface in a second side
surface different from the first side surface, the concave side surface extending to
the bottom perimeter concave portion.
Although the specification of the ’615 Patent describes an embodiment of an access port
wherein an identifiable feature may be perceived by a person through touch, the asserted claim
does not recite this alleged innovation. Indeed, the claim language completely fails to describe
how a person may utilize the “one structural feature” to determine any identifying information
about the port. “The main problem that [Bard] cannot overcome is that the claim—as opposed to
something purportedly described in the specification—is missing an inventive concept.”192
Second, the evidence presented by MedComp establishing the use of shape identifiers in
the medical device field is persuasive. MedComp provides articles and charts from medical
journals dating between 1969 to 2019, describing the use of shape to differentiate between the
brand and type of implanted pacemakers.193 While the articles do not address the innovation of

190

Berkheimer, 881 F.3d at 1368.

191

Two-Way Media, 874 F.3d at 1338.

192

Id. (emphasis in original).

193

See Dkt. 463 at 19–22.
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using palpation in conjunction with the shape of the medical devices, it is clear that utilizing a
device’s shape to convey information is not a new concept. Consequently, in analyzing the
asserted claim language under Alice step two, the court finds that claim 8 of the ’615 Patent does
not contain an inventive concept.
Because the claims at issue are directed to the ineligible abstract idea of communicating
information and lack an inventive concept, the court holds that asserted claims 1, 3, 4, 5, 6, 7, 8
and 10 of the ’302 Patent, asserted claims 1, 3, 5, 8, 9, 10, 12, and 14 of the ’022 Patent, and
asserted claim 8 of the’615 Patent are invalid under § 101.
CONCLUSION
For the foregoing reasons, Defendant’s Motion for Partial Summary Judgment is
GRANTED IN PART on the grounds of invalidity.194
SO ORDERED this 22nd day of July 2021.
BY THE COURT:

________________________________________
ROBERT J. SHELBY
Chief United States District Judge

194

Dkt. 463.
40