Medline Industries, Inc.

Patent Trials and Appeals Board

Jun 3, 2020

IPR2019-00208 (P.T.A.B. Jun. 3, 2020)

Trials@uspto.gov Paper 57
Tel: 571-272-7822 Date: June 3, 2020
UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

C.R. BARD, INC.,
Petitioner,
v.
MEDLINE INDUSTRIES, INC.,
Patent Owner.

IPR2019-00208
Patent 9,808,400 B2

Before JOSIAH C. COCKS, MITCHELL G. WEATHERLY, and
TIMOTHY J. GOODSON, Administrative Patent Judges.
WEATHERLY, Administrative Patent Judge.
JUDGMENT
Final Written Decision
Determining All Challenged Claims Unpatentable
35 U.S.C. § 318(a)
I. INTRODUCTION
A. BACKGROUND
C.R. Bard, Inc. (“Petitioner”) filed a petition (Paper 2, “Pet.”) to
institute an inter partes review of claims 13, 14, 16, and 17 (the “challenged
claims”) of U.S. Patent No. 9,808,400 B2 (Ex. 1001, “the ’400 patent”).
IPR2019-00208
Patent 9,808,400 B2
2
35 U.S.C. § 311. Medline Industries, Inc. (“Patent Owner”) timely filed a
Preliminary Response. Paper 12 (“Prelim. Resp.”). On June 6, 2019, based
on the record before us at the time, we instituted an inter partes review of all
challenged claims and all grounds advanced by Petitioner. Paper 21
(“Institution Decision” or “Dec.”). The table below lists the challenges to
the claims:
Claims Challenged 35 U.S.C. § References
13, 14, 16, 17 103 Solazzo1, Serany,2 Boedecker3
13, 14, 16, 17 103 Solazzo, Serany, Peterson4
13, 14 103 Solazzo, Disston,5 Boedecker
16, 17 103 Solazzo, Disston, Boedecker, Serany
13, 14, 16, 17 103 Solazzo, Nursing Standard6
After we instituted this review, Patent Owner filed a Patent Owner
Response in opposition to the Petition. Paper 31 (“PO Resp.”). Petitioner
filed a Reply in support of the Petition. Paper 42 (“Reply”). Patent Owner
filed a Sur-reply. Paper 48 (“Sur-reply”). With our authorization, each
party filed a brief addressing a recent decision from our reviewing court, Fox

1 U.S. Patent No. 7,278,987 B2 (Ex. 1005, “Solazzo”).
2 U.S. Patent No. 3,329,261 (Ex. 1006, “Serany”).
3 U.S. Patent No. 3,965,900 (Ex. 1034, “Boedecker”).
4 U.S. Patent No. 4,334,537 (Ex. 1036, “Peterson”).
5 U.S. Patent No. 3,166,189 (Ex. 1008, “Disston”).
6 M. Madeo and A. J. Roodhouse, Reducing the risks associated with
urinary catheters, NURSING STANDARD, March 25–31, 2009, at 47–55
(Ex. 1025, “Nursing Standard”).
IPR2019-00208
Patent 9,808,400 B2
3
Factory, Inc. v. SRAM, LLC, 944 F.3d 1366 (Fed. Cir. 2019). Papers 51, 52.
Patent Owner did not move to amend any claim of the ’400 patent.
We heard oral argument on March 5, 2020. A transcript of the
argument has been entered in the record (Paper 56, “Tr.”).
We have jurisdiction under 35 U.S.C. § 6. The evidentiary standard is
a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R.
§ 42.1(d). This Final Written Decision is issued pursuant to 35 U.S.C.
§ 318(a) and 37 C.F.R. § 42.73.
For the reasons expressed below, we conclude that Petitioner has
demonstrated by a preponderance of evidence that claims 13, 14, 16, and 17
are unpatentable.
B. RELATED PROCEEDINGS
The parties identified as a related proceeding the co-pending district
court proceeding of Medline Industries, Inc. v. C. R. Bard, Inc., Case
Number 1:17-cv-07216 (N.D. Ill.) (“Medline III Litigation”). Pet. 92;
Paper 3, 2. The parties collectively also identify as related matters petitions
for inter partes review of claims of: U.S. Patent 9,745,088 B2 (IPR2019-
00035 and IPR2019-00036); U.S. Patent 9,795,761 B2 (IPR2019-00109);
and U.S. Patent 9,808,596 B2 (IPR2019-00223). Pet. 92–93; Paper 3, 3.
Patent Owner further identifies as a related matter U.S. Patent Application
No. 15/804,520, which is a continuation-in-part of the application that issued
as the ’400 patent. Paper 3, 2. Patent Owner further identifies U.S. Patent
Application Nos. 15/703,514; 15/684,787; 15/803,383; 13/374,509;
15/640,224; 14/265,920; and 15/051,964 as related matters because these
applications “share similar disclosures and claim language” with the
’400 patent. Id.
IPR2019-00208
Patent 9,808,400 B2
4
C. THE ’400 PATENT
The ’400 patent is directed to “storage containers for medical devices,
and more particularly to a storage container for a long, flexible medical
implement, such as a catheter, and related medical devices.” Ex. 1001,
1:21–24. The Specification describes tray 100 shown in Petitioner’s
annotated and colorized version of Figure 7, which we reproduce below.

Figure 7 illustrates catheter assembly 700, two syringes 701,
702, and specimen container 703 located within single-level
tray 100. Id. at 8:7–15.
Before use, tray 100 is optionally double-wrapped to ensure that
components in the tray remain sterile up to and through their initial use with
tray 100 being wrapped in CSR wrap 1000 and then outer sterile wrap 1002.
Id. at 9:39–49, Fig. 10. Tray 100 includes three compartments 101, 102, 103
adapted to accept various items used in a catheterization procedure. Id.
IPR2019-00208
Patent 9,808,400 B2
5
at 8:19–25. First compartment 101 accommodates syringes 701, 702 (red,
green) containing sterile water or lubricants. Id. at 3:26–30, 8:21–23.
Second compartment 102 accommodates catheter assembly 700 (blue)
comprising indwelling (or Foley) catheter coupled to fluid bag 730 by
tube 720. Id. at 8:23–27. First end portion 721 of tube 720 is coupled to the
indwelling catheter and second end portion 722 of tube 720 is coupled to the
fluid bag 730 via anti-reflux device 731. Id. at 8:27–30. Third compartment
103 accommodates specimen container 703 for capturing samples taken
from the patient via catheter 700. Id. at 8:30–32. Additional objects can be
included with the tray, including one or more towels, a drape to cover the
patient, rubber gloves, hand sanitizing materials, printed instructions, and so
forth. Id. at 4:54–57.
Claim 13 is the only independent claim among the challenged claims.
Id. at 11:47–12:7. Claim 13, which is illustrative, recites:
13. A kit, comprising:
[a][i] a single level tray including a first compartment base
member and a second compartment base member,
[ii] the single level tray defining a first compartment and a
second compartment,
[iii] the first compartment base member forming a portion of
a boundary of the first compartment, the second
compartment base member forming a portion of a
boundary of the second compartment,
[iv] the single level tray including a barrier separating the first
compartment from the second compartment;
[b] a first syringe disposed within the first compartment of the
single level tray, the first syringe containing an inflation fluid;
[c] a second syringe disposed within the single level tray, the
second syringe containing a lubricant; and
IPR2019-00208
Patent 9,808,400 B2
6
[d][i] a catheter assembly including a coiled tube coupling an
indwelling catheter to a fluid receptacle, the indwelling
catheter including an inflatable portion configured to receive
the inflation fluid from the first syringe to maintain the
indwelling catheter within a patient,
[ii] the fluid receptacle including an anti-reflux device, an end
of the coiled tube coupled to the anti-reflux device,
[iii] the coiled tube and the fluid receptacle disposed within
the second compartment of the single level tray with at
least a portion of the coiled tube being outside of the fluid
receptacle and such that the fluid receptacle is between the
second compartment base member and the coiled tube.
Id. at 11:47–12:7 (with line breaks and bracketed labels added to ease
discussion).
II. ANALYSIS
A. CLAIM INTERPRETATION
“A claim in an unexpired patent that will not expire before a final
written decision is issued shall be given its broadest reasonable construction
in light of the specification of the patent in which it appears.” 37 C.F.R.
§ 42.100(b) (2018)7; see also Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct.
2131, 2144–46 (2016) (affirming that USPTO has statutory authority to
construe claims according to Rule 42.100(b)). When applying that standard,
we interpret the claim language as it would be understood by one of ordinary

7 Our recently changed version of this Rule, which requires that we interpret
claims in the same manner used in a civil action under 35 U.S.C. § 282(b),
does not apply here because the Petition was filed before the effective date
of the new Rule, November 13, 2018. See Changes to the Claim
Construction Standard for Interpreting Claims in Trial Proceedings Before
the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340, 51,344 (Oct. 11,
2018).
IPR2019-00208
Patent 9,808,400 B2
7
skill in the art in light of the specification. In re Suitco Surface, Inc., 603
F.3d 1255, 1260 (Fed. Cir. 2010). Thus, we give claim terms their ordinary
and customary meaning. See In re Translogic Tech., Inc., 504 F.3d 1249,
1257 (Fed. Cir. 2007) (“The ordinary and customary meaning ‘is the
meaning that the term would have to a person of ordinary skill in the art in
question.’”). Only terms that are in controversy need to be construed, and
then only to the extent necessary to resolve the controversy. Vivid Techs.,
Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).
Petitioner recounts interpretations of various terms that Patent Owner
proposed during district court litigation and alleges that the prior art meets
those limitations. Pet. 23–24. Patent Owner does not address any of these
proposed interpretations. See generally PO Resp. (not expressly addressing
meaning of any claim term).
Accordingly, we discern no reason to expressly interpret any term of
the ’400 patent.
B. THE PARTIES’ POST-INSTITUTION ARGUMENTS
In our Institution Decision, we concluded that the argument and
evidence adduced by Petitioner demonstrated a reasonable likelihood that
claims 13, 14, 16, and 17 were unpatentable as obvious. Dec. 19–27. We
must now determine whether Petitioner has established by a preponderance
of the evidence that the specified claims are unpatentable over the cited prior
art. 35 U.S.C. § 316(e) (2018). We previously instructed Patent Owner that
“any arguments for patentability not raised in the [Patent Owner Response]
will be deemed waived.” Paper 22, 7; see also In re Nuvasive, Inc., 842 F.3d
1376, 1381 (Fed. Cir. 2016) (holding that patent owner’s failure to proffer
argument at trial as instructed in scheduling order constitutes waiver).
IPR2019-00208
Patent 9,808,400 B2
8
Additionally, the Board’s Trial Practice Guide states that the Patent Owner
Response “should identify all the involved claims that are believed to be
patentable and state the basis for that belief.” Office Patent Trial Practice
Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012).
C. LEGAL STANDARDS
Petitioner challenges the patentability of claims 13, 14, 16, and 17 on
the grounds that the claims are obvious in light of various references
including: Solazzo, Serany, Boedecker, Peterson, Disston, and Nursing
Standard. To prevail in its challenges to the patentability of the claims,
Petitioner must establish unpatentability by a preponderance of the evidence.
35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d) (2018). “In an [inter partes review],
the petitioner has the burden from the onset to show with particularity why
the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc.,
815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3)
(requiring inter partes review petitions to identify “with particularity . . . the
evidence that supports the grounds for the challenge to each claim”)). This
burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l
Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (citing Tech. Licensing
Corp. v. Videotek, Inc., 545 F.3d 1316, 1326–27 (Fed. Cir. 2008))
(discussing the burden of proof in inter partes review).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550
U.S. 398 (2007), reaffirmed the framework for determining obviousness as
set forth in Graham v. John Deere Co., 383 U.S. 1 (1966). The KSR Court
summarized the four factual inquiries set forth in Graham that we apply in
determining whether a claim is unpatentable as obvious under 35 U.S.C.
§ 103(a) as follows: (1) determining the scope and content of the prior art,
IPR2019-00208
Patent 9,808,400 B2
9
(2) ascertaining the differences between the prior art and the claims at issue,
(3) resolving the level of ordinary skill in the pertinent art, and
(4) considering objective evidence indicating obviousness or
nonobviousness. KSR, 550 U.S. at 406 (citing Graham, 383 U.S. at 17–18).
In an inter partes review, Petitioner cannot satisfy its burden of proving
obviousness by employing “mere conclusory statements.” In re Magnum
Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Thus, to prevail
Petitioner must explain how the proposed combinations of prior art would
have rendered the challenged claims unpatentable. With these standards in
mind, we address each challenge below.
D. LEVEL OF ORDINARY SKILL IN THE ART
The parties generally agree that a person having an ordinary level of
skill in the relevant art would have a bachelor’s degree in packaging
engineering, mechanical engineering, or industrial design. Pet. 21–22 (citing
Ex. 1002 ¶ 14); PO Resp. 16 (citing Ex. 2040 ¶ 37). Alternatively, such a
person could have an engineering degree in another technical field along
with about two years of experience designing medical packaging.
Pet. 21–22 (citing Ex. 1002 ¶ 14); PO Resp. 16 (citing Ex. 2040 ¶ 37).
Neither party contends that a person of ordinary skill needs to be a medical
practitioner, but both parties agree that the person of ordinary skill would
consult with medical practitioners familiar with catheterization procedures.
Pet. 21–22; PO Resp. 16–17 (citing Ex. 2041 ¶ 78).
Although slight differences exist in the formulation of the level of
ordinary skill between the parties, we discern no meaningful differences
because none of those differences would affect the outcome of our analysis.
Accordingly, we apply the level of skill set forth in the preceding paragraph.
IPR2019-00208
Patent 9,808,400 B2
10
E. CLAIMS 13, 14, 16, 17:
OBVIOUSNESS IN VIEW OF SOLAZZO, SERANY, AND BOEDECKER
Petitioner argues that claims 13, 14, 16, and 17 are unpatentable as
obvious in view of the combined teachings of Solazzo, Serany, and
Boedecker. Pet. 25–57. Claim 13 is the only independent claim among this
group of challenged claims. Ex. 1001, 11:47–12:28. Patent Owner argues
that the combination of Solazzo, Serany, and Boedecker fails to render
independent claim 13, and thus dependent claims 14, 16, and 17,
unpatentable as obvious. PO Resp. 17–36. For the reasons expressed
below, we determine that Petitioner has demonstrated by a preponderance of
evidence that the combined teachings of Solazzo, Serany, and Boedecker
render claims 13, 14, 16, and 17 unpatentable as obvious.
1. Overview of the Prior Art
a) Solazzo
Solazzo is directed to an ergonomic, single layer
catheterization/irrigation tray 1 having multiple compartments, including
recessed area 3, compartment 27, and wells 31, 33 as shown in Figure 1,
which we reproduce below right. Ex. 1005, 4:15–25; Fig.1. Solazzo’s
Figure 1 is a perspective view of
the catheterization and irrigation
tray illustrating its major
features. Id. at 3:31–33. Divider
wall 17 is optional and, when
present, divides recessed area 3
into two compartments, with
compartment 27 being
IPR2019-00208
Patent 9,808,400 B2
11
configured to receive fluid passing over top 25 of wall 17. Id. at 4:15–20.
Recessed area 3 is trapezoidal-
shaped with a “non constant depth”
provided by a terraced bottom 11 having
low area 11A and shallow area 11B as
shown in Figure 2, reproduced at right. Id.
at 3:61–66; Fig. 5. Recessed area 3 and
compartment 27 store the medical devices
of tray kit 100, including Foley
catheter 120, urinary tract lubricant 140, surgical gloves 130, inflation
syringe 110, irrigation syringe (not shown), evacuation tubing, and antiseptic
solutions as shown in Solazzo’s Figure 8, which is a top view of kit 100 that
we reproduce below. Id. at 3:14–24, 4:1–8; Fig. 8.

IPR2019-00208
Patent 9,808,400 B2
12
Solazzo’s Figure 8 is a top view of kit 100 illustrating various
components stored in compartments of tray 1. Id. at 4:41–48.
Inflation syringe 110 is stored at low area 11A, and lubricant 140 is stored at
shallow area 11B. Id. at 4:41–45; Fig. 8.
In use, the recessed area 3 and compartment 27 fit between the legs of
a “patient requiring an urological procedure” while flange 15 and wing
supports 21, 23 rest atop the legs while the patient is seated. Id. at 1:8–12,
3:66–4:10, 4:26, 4:32–33; Fig.1. A surgeon proceeds to “evacuate the
bladder of its contents, urine and/or clots” using kit 100, e.g., by wearing the
gloves, lubricating and inserting the catheter, and inflating it with inflation
syringe 110. Id. at 4:32–33, 4:46–48.
b) Serany
Serany is directed to a
double-wrapped, sterile
package providing
catheterization components
ready for use in the order
needed. Ex. 1006, 1:8–16,
1:60–63, 3:63–4:2; Figs. 1–3,
5. Serany’s Figure 5
(reproduced at right in
pertinent part) is an exploded
view illustrating how various
compartments are positioned
within Serany’s box 10. The
package includes multi-
compartment single-layer tray 12 mounted on box 10 and enclosed with
IPR2019-00208
Patent 9,808,400 B2
13
sealed outer envelope 16 and inner wrap 14 that unfolds to provide a sterile
field work area. Id. at 1:60–72, 2:17–20; Figs. 1–5.
Prefilled syringe 45 of sterile water in depression 44, which includes
indentations 44d along the sides to accommodate the syringe’s flange. Id.
at 2:40–41, 3:6–22; Figs. 6–7. Serany’s package further includes a
waterproof underpad 20, gloves 22, fenestrated drape 24, cleansing solution
bottle 30, rayon balls 34, forceps 36, lubricating jelly pouch 40, safety
pin 41, and rubber band 42. Serany describes its package as containing “all
the essential equipment, . . . for a complete [] catheterization procedure. . . .
Everything is available in the proper order of use and in a sterile condition.”
Id. at 1:16–25.
Box 10 also includes Foley
catheter 48 that is preconnected to a
collapsible drainage bottle 46 via tube 49
and “ready for use” as shown in Serany’s
Figure 6, which is reproduced at right. Id.
at 2:22–33, 2:57–70, 3:1–5, 3:23–26,
Figs. 5–6. The collapsible drainage
“bottle 46 is made of flexible plastic
material having fold lines 46a . . . so that it
may be folded flat for storage . . . and
expanded into cube form when in use. The bottle is shown in FIG. 6
partially expanded for illustration purposes.” Id. at 3:26–31; Fig. 6.
Catheter 48 and tubing 49 are coiled in the box about bottle 46 as shown in
Figure 6. Id. at 3:33–35.
IPR2019-00208
Patent 9,808,400 B2
14
c) Boedecker
Boedecker describes an anti-reflux device for
use with a flexible collection receptacle during
urinary catheterization. Ex. 1034, 1:5–9,
Figures 1–2. The configuration of Boedecker’s
collection bag 24 is illustrated in Boedecker’s
Figure 1, which we reproduce at right. Drainage
tube 22 is connected to drainage bag 24 via drip
chamber 26. Boedecker describes that pressure exerted against the flexible
walls of such receptacles may cause urine to back up into the drainage tube,
catheter, and patient’s bladder, which may cause trauma or retrograde
bacterial movement to the bladder. Id. at 1:19–35.
To address this issue, Boedecker’s drip
chamber 26 includes valve element 34 with lip 36,
which is shown in its open position in Boedecker’s
Figure 5, reproduced at right. Id. at 2:54–3:3, 3:20–23;
Figures 1–2, 5. When pressure is exerted onto flexible
valve element 34 from inside the bag 24 (e.g., by
inadvertent squeezing, bumping, tilting of the bag),
lip 36 of flexible valve element 34 closes inlet port 30
to prevent reflux. Id. at 3:23–33.
2. Claim 13
a) Petitioner’s Argument and Evidence
Petitioner argues that the combined teachings of Solazzo, Serany, and
Boedecker render claim 13 unpatentable as obvious. Pet. 25–52. We find
Petitioner’s arguments and citations to evidence persuasive and adopt them
IPR2019-00208
Patent 9,808,400 B2
15
as our own. For example, Petitioner persuasively demonstrates that Solazzo
describes the tray and its compartments (element 13a), id. at 33–37 (citing
Ex. 1005, 2:61–63, 3:63–66, Figs. 1, 2, 8; Ex. 1002 ¶¶ 139–154), the first
and second syringes and the manner in which they are ordered within the
tray (elements 13b, 13c), id. at 37–40 (citing Ex. 1005, 3:15–24, 4:41–46,
Fig. 8; Ex. 1002 ¶¶ 153–163), and a catheter disposed in the second
compartment (aspects of element 13d.i), id. at 40–42 (citing Ex. 1005,
3:15–24, Fig. 8; Ex. 1003 ¶ 11).
We further find that Petitioner has shown that Serany describes an
indwelling catheter coupled to a drainage receptacle (aspects of element
13d.i), id. at 42–43 (citing Ex. 1006, 3:23–26, 3:33–35, Fig. 6), between a
base member of the second compartment and the coiled tube (element
13d.iii), id. at 50 (citing Ex. 1006, 3:26–35, Fig. 6).
Petitioner also persuasively demonstrates that Boedecker describes an
anti-reflux device (element 13d.ii) and suggests the use of such a device with
Foley catheter systems. Id. at 45–48 (citing Ex. 1034, 1:13–17, 1:19–35,
1:45–47, 2:48–52, 3:30–32, Figs. 1, 2; Ex. 1002 ¶¶ 180–185; Ex. 1004, 262
¶ 41).
Petitioner recognizes that Solazzo does not describe a closed-system
Foley catheter in which the catheter is pre-connected to a drainage
receptacle. Id. at 42. Petitioner persuasively argues, however, that Serany
suggests that Solazzo’s tray could hold Serany’s closed-system Foley
catheter, i.e., the claimed “catheter assembly,” because an ordinarily skilled
artisan would have been motivated to simplify Solazzo’s catheterization
procedure and reduce the risk of infection. Id. at 43–45 (citing Ex. 1006,
IPR2019-00208
Patent 9,808,400 B2
16
1:31–32, 3:23–36; Ex. 1002 ¶¶ 171–174, 390; Ex. 1003 ¶¶ 35, 41, 42;
Ex. 1004, 239 ¶ 29; Ex. 1010, 51, 52).
Petitioner also recognizes that neither Solazzo nor Serany expressly
describes using an anti-reflux device in a catheter assembly. However,
Petitioner persuasively argues that Patent Owner never contested the
Office’s finding that such devices in catheter systems were well known. Id.
at 45 (citing Ex.1004, 73–76, 106–08, 262, ¶ 41). Moreover, Petitioner
persuasively argues that it would have been obvious to replace Serany’s
expandable bottle 46 with Boedecker’s liquid collection bag 24, which
includes an anti-reflux device. Id. at 47–48 (citing Ex. 1034, 1:19–35;
Ex. 1002 ¶ 185). Petitioner also demonstrates that Boedecker expressly
suggests such a modification to reduce infection. Id. at 46–48 (citing
Ex. 1034, 1:19–35; Ex. 1002 ¶¶ 180–185).
b) Analysis of Patent Owner’s Counterarguments
Patent Owner argues that Petitioner’s challenge to claim 13 fails for a
number of reasons. Patent Owner contends that the prior art fails to describe
certain elements of independent claim 13. PO Resp. 22–24, 34–36. Patent
Owner also argues that an ordinarily skilled artisan would not have been
motivated to combine teachings of Solazzo and Serany as Petitioner posits.
Id. at 24–34. Patent Owner further argues that objective evidence of
non-obviousness strongly weighs against a conclusion that claims 13, 14, 16,
and 17 are directed to obvious subject matter. Id. at 40–67. We find that
none of Patent Owner’s arguments overcomes the persuasiveness of
Petitioner’s positions for the reasons that follow.
IPR2019-00208
Patent 9,808,400 B2
17
(1) Elements 13b and 13c
Patent Owner contends that claim 13 requires “two syringes to be
provided in one compartment that is separate from the compartment storing
the catheter assembly.” PO Resp. 22. We disagree. Claim 13 recites “a first
syringe disposed within the first compartment . . . containing an inflation
fluid” (element 13b) and “a second syringe disposed within the single level
tray . . . containing a lubricant” (element 13c). Ex. 1001, 11:57–61
(emphases added). Accordingly, it is apparent that the first syringe must be
placed in one compartment and the second syringe may be placed anywhere
“within the single level tray.” Dr. Singh, Patent Owner’s expert, agrees.
Ex. 1154, 92:20–94:1.
Based upon Patent Owner’s incorrect contention that claim 13
requires two syringes in one compartment that differs from the compartment
holding a catheter assembly, Patent Owner argues that the combined
teachings of Solazzo and Serany fail to describe all elements of claim 13.
Petitioner persuasively contends that Solazzo expressly teaches syringe 110
in one compartment and Foley catheter 120 in another compartment of its
single layer tray. Reply 2 (citing Ex. 1005, Fig. 8). Petitioner also
persuasively points out that Solazzo describes two syringes within its single
level tray, an inflation syringe and an irrigation syringe. Pet. 28; Reply 2
(both citing Ex. 1005, 3:14–24). Although Solazzo describes placing
lubricant in tube 140 rather than a syringe, Petitioner persuasively argues
that an ordinarily skilled artisan would have considered it to be obvious to
place the lubricant in a syringe as a known substitute used for a known
purpose. Pet. 39–40 (citing Ex. 1002 ¶¶ 160–162). Ms. Chiappetta, Patent
IPR2019-00208
Patent 9,808,400 B2
18
Owner’s nurse practitioner expert, testified that her “preference would be a
syringe . . . it’s easier to get the lubricant out of it.” Ex. 1073, 60:23–61:24.
For the reasons expressed above, we determine that Petitioner has
demonstrated by a preponderance of evidence that the combined teachings
of Solazzo and Serany suggest the inflation and lubrication syringes placed
in the tray as required by elements 13b and 13c.
(2) Element 13d.iii
Element 13d.iii refers to the following portion of claim 13: “the
coiled tube and the fluid receptacle disposed within the second compartment
of the single level tray with at least a portion of the coiled tube being outside
of the fluid receptacle and such that the fluid receptacle is between the
second compartment base member and the coiled tube.” Ex. 1001, 12:1–7.
Petitioner correctly notes that Solazzo describes placing its
catheter 120 in recessed area 3 (i.e., the second compartment). Pet. 49
(citing Ex. 1005, Figure 8). Petitioner relies upon Serany’s arrangement in
which “catheter 48 and drainage tubing 49 connecting it to the bottle 46 are
coiled in the box about the bottle.” Id. at 50 (quoting Ex. 1006, 3:33–35).
When stored in this manner, Serany’s bottle 46 is folded flat between the
bottom of box 10 and tube 49. Id. (citing Ex. 1006, 3:26–32). Petitioner
argues that Serany suggests arranging the closed-system Foley catheter with
the drainage receptacle under the tubing and on the bottom of the tray by
indicating that components should be arranged in their “proper order of use.”
Id. at 51 (citing Ex. 1006, 1:9–12, 1:23–25; Ex. 1002 ¶¶ 192–194).
Patent Owner argues that Serany fails to meet element 13.d.iii because
Serany’s coiled tubing is not disposed “such that the fluid receptacle is
between the second compartment base member and the coiled tube.” PO
IPR2019-00208
Patent 9,808,400 B2
19
Resp. 34–35. Patent Owner relies upon Serany’s Figure 6 and testimony
from Dr. Singh to support its position. Id. at 35 (citing Ex. 1006, Fig. 6;
Ex. 2040 ¶¶ 80–82). Based on his review of Figure 6 and Serany’s
description of the tubing as “coiled in the box about the bottle,” Dr. Singh
concludes that Serany illustrates tubing “coiled about, rather than on top of,
the drainage bottle.” See, e.g., Ex. 2040 ¶ 81. We disagree.
We have reproduced
Petitioner’s annotated and colorized
version of Serany’s Figure 6 at right,
which is a partially exploded view
of Serany’s kit illustrating the
contents of tray 12 and box 10.
Patent Owner’s argument presumes
that the claim requires that all the
tubing is positioned above the bag to
meet the requirement that “the fluid
receptacle is between the second
compartment base member and the
coiled tube.” However, we read element 13d.iii more broadly to encompass
fluid receptacles in which at least part of the receptacle is arranged between
the tubing and the second compartment base member. Claim 14, which
depends from claim 13 and is thus subsumed within that claim, confirms our
reading of claim 13 by reciting that: “the coiled tube and the fluid receptacle
are disposed within the second compartment of the single level tray with at
least a portion of the fluid receptacle being beneath the coiled tube.”
Ex. 1001, 12:8–11.
IPR2019-00208
Patent 9,808,400 B2
20
Serany’s Figure 6 does not illustrate every part of tubing 49 (blue)
extending from fitting 50 on the top of bottle 46 (orange) to catheter 48
(red). However, the figure illustrates a portion of coiled tubing 49 (blue)
near its connection to fitting 50, which establishes that at least a portion of
bottle 46 (orange) is unambiguously between coiled tubing 49 (blue) and the
bottom (i.e., base member) of box 10. Mr. Singh agreed that Serany’s
tubing 49 is connected to the top of Serany’s bottle 46 (i.e., the claimed fluid
receptacle). Ex. 1154, 152:12–17. We therefore determine that Petitioner
has shown that Serany describes element 13d.iii.
(3) Motivations to Combine Teachings of Solazzo and Serany
Patent Owner argues that an ordinarily skilled artisan would not have
been motivated to combine the teachings of Solazzo and Serany for two
reasons. As explained below, Petitioner persuasively overcomes both
arguments.
First, Patent Owner argues that “fundamental differences” between
Solazzo and Serany would counsel against modifying Solazzo to hold
Serany’s fluid receptacle for its Foley catheter. PO Resp. 24–27. Patent
Owner argues that because Solazzo’s Foley catheter 120 is an “open
design,” which is not connected to a fluid receptacle, an ordinarily skilled
artisan would not alter Solazzo’s catheter into a closed system catheter. Id.
at 24–25 (citing Ex. 2041 ¶¶ 164, 166–173). The testimony from
Ms. Chiappetta, upon which Patent Owner rests, points out that open and
closed catheter systems have different uses and that commercial open
systems may not have space to accommodate a catheter bag. Ex. 2041
¶¶ 166–173.
IPR2019-00208
Patent 9,808,400 B2
21
Petitioner argues that an ordinarily skilled artisan would have found it
obvious to substitute a closed-catheter as described by Serany for Solazzo’s
open-catheter 120 and place it in Solazzo’s recessed area 3. Id. at 43–45.
Petitioner contends that an ordinarily skilled artisan would have been
motivated to do so because modifying Solazzo to incorporate a “ready for
use” closed-catheter system would simplify Solazzo’s catheterization
procedure and reduce the risk of infection for patients. Id. (citing Ex. 1002
¶¶ 171–173, 390; Ex. 1003 ¶ 35; Ex. 1004, 239 ¶ 29; Ex. 1006, 1:20–23,
3:26; Ex. 1010, 51, 52). Petitioner also contends that including a closed-
catheter assembly in Solazzo’s kit would render Solazzo’s kit more versatile
because the modified kit could be used for both permanent catheterization
and irrigation procedures. Id. at 45 (citing Ex. 1002 ¶ 174; Ex. 1003 ¶¶ 41,
42).
Ms. Chiappetta admits that closed catheter systems are “always
better” for reducing the incidence of catheter acquired urinary tract infection
(“CAUTI”). Ex. 1073, 81:23–82:9. Accordingly, her testimony supports
Petitioner’s position that modifying Solazzo’s Foley catheter from an open
to a closed system (i.e., with the bag described by Serany) would have been
desirable to skilled artisans. Therefore, Petitioner persuades us that an
ordinarily skilled artisan would have been motivated and have considered it
obvious to incorporate the closed catheter concept from Serany into
Solazzo’s kit.
Second, Patent Owner argues that it would not have been obvious to
modify Solazzo’s Foley catheter to a closed system because doing so would
render Solazzo “inoperable for its intended purpose.” PO Resp. 27–34.
More specifically, Patent Owner contends that including a bag in Solazzo’s
IPR2019-00208
Patent 9,808,400 B2
22
kit would require enlarging Solazzo’s tray to such an extent that it could no
longer be used between a patient’s legs, the allegedly fundamental purpose
of Solazzo’s design. Id. at 28 (citing Ex. 2040 ¶¶ 97–103; Ex. 2041 ¶ 166;
Ex. 1005, 1:7–13, 3:9–11, 3:66–4:3).
Petitioner persuasively establishes that the expert testimony relied
upon by Patent Owner is inconsistent with testimony elicited on cross
examination. Reply 5–7. For example, Dr. Singh testified that Solazzo’s
tray would accommodate evacuation tubing, which would be three to five
feet long. Ex. 1074, 185:17–189:19. Mr. Plishka and Dr. Yun both testified
that Solazzo being able to accommodate such a length of tubing would
necessarily mean that Solazzo could also accommodate a closed catheter
assembly, which would include tubing of three to four feet. Ex. 1070 ¶ 8;
Ex. 1071 ¶ 35. Ms. Chiappetta testified that a tapered, open system tray,
such as Solazzo’s tray, could also accommodate a closed-system Foley
catheter. See Ex.1073, 162:1–165:5 (contradicting her declaration testimony
that a closed Foley catheter does not fit in tapered tray for use between a
patient’s legs made by Bard).
Even if we were to conclude that a primary purpose of Solazzo’s tray
were to fit between a patient’s legs, Petitioner has shown that placing a
closed Foley catheter in such a tray would not have frustrated that purpose.
Accordingly, Petitioner persuades us that an ordinarily skilled artisan would
have considered it obvious to modify Solazzo’s tray to include a drainage
bag connected to its Foley catheter (i.e., a closed system).
(4) Objective Indicia
Patent Owner argues that four types of objective indicia of non-
obviousness demonstrate that Petitioner’s challenges based on Solazzo,
IPR2019-00208
Patent 9,808,400 B2
23
Serany, and Boedecker fail. PO Resp. 40–67. Patent Owner bears the
burden of establishing that a nexus exists “between the evidence and the
patented invention.” Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373
(Fed. Cir. 2019). Patent Owner is entitled to a rebuttable presumption of
nexus “when the patentee shows that the asserted objective evidence is tied
to a specific product and that product ‘embodies the claimed features, and is
coextensive with them.’” Id. (quoting Polaris Indus., Inc. v. Arctic Cat, Inc.,
882 F.3d 1056, 1072 (Fed. Cir. 2018) (quoting Brown & Williamson
Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir.
2000))); see also Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-01129,
Paper 33 at 32 (PTAB Jan. 24, 2020) (Final Written Decision)
(precedential). “A patent claim is not coextensive with a product that
includes a ‘critical’ unclaimed feature that is claimed by a different patent
and that materially impacts the product’s functionality.” Fox Factory, 944
F.3 at 1375. Nevertheless, even if a patentee fails to demonstrate a
presumption of nexus, it may directly establish a nexus between the claimed
invention and the objective evidence of non-obviousness. Id. at 1378. The
patentee bears the burden of directly proving such a nexus. Id.
The parties addressed the issue of whether Patent Owner had proven a
nexus between the claims and the evidence in their primary briefing. See,
e.g., PO Resp.; Reply; Sur-reply. With our prior authorization, each party
filed a supplemental brief on how the principles relating to nexus set forth in
the Fox Factory decision apply to the record in this proceeding. Paper 52
(“Pet. Br.”); Paper 51 (“PO. Br.”). Based on our review of the record, we
determine that Patent Owner has not demonstrated that nexus exists between
its claims and its objective evidence of non-obviousness.
IPR2019-00208
Patent 9,808,400 B2
24
Patent Owner argues that because “the ’400 patent covers both
Medline and Bard’s products . . . nexus between Medline’s objective
evidence and the ’400 patent is presumed.” Sur-reply 4. Patent Owner
further argues that its “objective evidence is tied to the core elements of a
single layer tray and elements arranged for ease of use as claimed.” Id.
Patent Owner’s experts, upon whom Patent Owner relies, identify two
features that establish a nexus between the objective evidence and the
claims: the single-layer nature of the tray and the arrangement of items in
the tray such as syringes according to their order of use. Ex. 2040 ¶ 146;
Ex. 2041 ¶ 125; Ex. 2042 ¶¶ 8, 23. Neither feature provides a basis for a
finding that nexus exists between the claims and the objective evidence of
non-obviousness for the reasons expressed below.
The first feature allegedly demonstrating nexus, a “single level tray,”
is indisputably required by independent claim 13, and therefore all
challenged claims. Ex. 1001, 11:48. The second feature, the arrangement of
syringes in the tray according to their order of use is not required in the
challenged claims. Although claim 13 recites “a first syringe disposed
within the first compartment of the single level tray,” it does not require the
second syringe to be placed in the same compartment. Rather, the second
syringe need only be “disposed within the single level tray.” Id.
at 11:57–12:7. Therefore, the claim does not require that both syringes be
placed in the same compartment. Nor does the claim require that the first
and second syringes or any other component are arranged according to an
order of use. Accordingly, Patent Owner’s argument that nexus exists is
premised wholly upon the first feature, the single level tray.
IPR2019-00208
Patent 9,808,400 B2
25
However, single layer trays in catheterization kits were well known in
the prior art, for example, as shown by Solazzo. Ex. 1005, Figs. 1, 8. Patent
Owner cannot establish nexus by linking objective evidence of non-
obviousness to “prior art features in isolation or unclaimed features.” Fox
Factory, 944 F.3 at 1378. Accordingly, Patent Owner’s argument that it has
proven nexus exists is unpersuasive for at least this reason.
Patent Owner’s argument is also unpersuasive because it fails to link
the objective evidence to the single level tray. For example, Patent Owner
argues that its single level tray met a long felt need to reduce CAUTI.
Ms. Chiappetta testifies that because the “design of the tray guides the
clinician through the catheterization process” it “reinforces . . . aseptic
technique” to reduce the incidence of CAUTI. Ex. 2041 ¶ 125, 128. To
support her conclusion that single level trays reduce the incidence of
CAUTIs, Ms. Chiappetta cites anecdotal reports from three hospitals that
used Patent Owner’s commercial ERASE CAUTI trays and reported reduced
incidence of CAUTIs. Id. ¶¶ 131–135 (citing Ex. 2049; Ex. 2050;
Exs. 2057–2059).
Petitioner persuasively points out that the underlying evidence from
these three hospitals fails to support Patent Owner’s claims because (1) the
hospital did not report infection rates at all (Ex. 2057, 4), (2) Patent Owner
cherry-picked data in a manner that distorted the outcome (Ex. 2058, 7;
Ex. 1087, 2), and (3) the data reflected a reduction in infection rates that
mostly occurred before the hospital bought trays from Patent Owner
(Ex. 1085, 15). Reply 22–24. Petitioner also persuasively discredits
Ms. Chiappetta’s testimony that CAUTI rates declined in 2015–2016
because single level trays “had time to gain traction in the market,” Ex. 2041
IPR2019-00208
Patent 9,808,400 B2
26
¶ 73, because she was unaware that the apparent reduction in infection rates
largely reflected a change in the definition of CAUTI in 2015 to exclude
yeast infections, Ex. 1073, 209:9–22, 211:6–20; Ex. 1121. Reply 24.
Finally, Petitioner persuasively demonstrates that CAUTI rates declined
steadily before single level trays gained market share and thus decreased for
reasons unrelated to the claimed tray. Id. at 25 (citing Ex. 1122, 5; Ex. 1073,
218:7–14). Based on the entire record, we conclude that Patent Owner fails
to establish that single level trays reduced CAUTI rates rather than other
factors identified by Petitioner.
For the reasons expressed above, we determine that Patent Owner has
not established either a presumed nexus or nexus in fact between the claimed
subject matter and the objective evidence of non-obviousness. Accordingly,
we do not consider the objective evidence presented to weigh against
Petitioner’s challenges that claims 13, 14, 16, and 17 are obvious.
c) Conclusion
For the reasons expressed above, we conclude that Petitioner has
proven by a preponderance of evidence that the combined teachings of
Solazzo, Serany, and Boedecker render independent claim 13 unpatentable
as obvious.
3. Dependent Claim 14
Claim 14 depends directly from claim 13 and further recites that: “the
coiled tube and the fluid receptacle are disposed within the second
compartment of the single level tray with at least a portion of the fluid
receptacle being beneath the coiled tube.” Ex. 1001, 12:8–11. Petitioner
relies upon the same aspects of Solazzo and Serany as describing the
limitations introduced in claim 14 as it marshalled for demonstrating that the
IPR2019-00208
Patent 9,808,400 B2
27
prior art described element 13d.iii. Patent Owner does not separately
address dependent claim 14. See PO Resp. 17–36, 40–67 (addressing only
independent claim 13). For the same reasons expressed in Parts II.E.2
above, we conclude that Petitioner has demonstrated by a preponderance of
evidence that the combined teachings of Solazzo, Serany, and Boedecker
render claim 14 unpatentable as obvious.
4. Dependent Claim 16
Claim 16 depends directly from claim 13 and further recites that:
“[a] the single level tray defines a top opening through which the first
compartment and the second compartment can be accessed, [b] the kit
further comprising: a sterile wrap disposed about the single level tray
covering at least the top opening.” Ex. 1001, 12:19–24 (with labels added
for discussion purposes). Petitioner relies upon Solazzo as describing
element 16a. Pet. 52–53 (citing Ex. 1005, Fig. 1; Ex. 1002 ¶¶ 199–202).
Petitioner relies upon a combination of Solazzo and Serany and testimony by
Mr. Plishka to demonstrate that the combination describes and suggests
element 16b. Id. at 53–55 (citing Ex. 1005, 3:15–24; Ex. 1006, 1:13–16,
1:60–63, 2:1–20, Fig. 3; Ex. 1002 ¶¶ 203–213). Patent Owner does not
separately address dependent claim 14. See PO Resp. 17–36, 40–67
(addressing only independent claim 13). Based on our review of the
argument and evidence submitted by Petitioner, which we adopt as our own,
we conclude that Petitioner has demonstrated by a preponderance of
evidence that the combined teachings of Solazzo, Serany, and Boedecker
render claim 16 unpatentable as obvious.
IPR2019-00208
Patent 9,808,400 B2
28
5. Dependent Claim 17
Claim 17 depends directly from claim 16 and further recites that:
“when the sterile wrap is unwrapped from about the top opening at least the
first syringe, the second syringe, and the indwelling catheter are revealed.”
Ex. 1001, 12:25–28. Petitioner relies upon a combination of Solazzo and
Serany and testimony by Mr. Plishka to demonstrate that the combination
describes and suggests the limitations introduced in claim 17. Pet. 56–57
(cross-referencing discussion of claim 16 and citing Ex. 1002 ¶¶ 214–219).
Patent Owner does not separately address dependent claim 17. See PO
Resp. 17–36, 40–67 (addressing only independent claim 13). Based on our
review of the argument and evidence submitted by Petitioner, which we
adopt as our own, we conclude that Petitioner has demonstrated by a
preponderance of evidence that the combined teachings of Solazzo, Serany,
and Boedecker render claim 17 unpatentable as obvious.
6. Conclusion
For the reasons expressed above, we conclude that Petitioner has
demonstrated by a preponderance of evidence that the combined teachings
of Solazzo, Serany, and Boedecker render claims 13, 14, 16, and 17
unpatentable as obvious.
F. CLAIMS 13, 14, 16, AND 17:
OBVIOUSNESS IN VIEW OF SOLAZZO, SERANY, AND PETERSON
Petitioner’s challenge to claims 13, 14, 16, and 17 based on the
combined teachings of Solazzo, Serany, and Peterson rests upon
substantially the same argument and evidence as the challenge discussed in
Part II.E above. However, Petitioner relies upon Peterson rather than
Boedecker as describing the “anti-reflux device” recited in element 13d.ii
IPR2019-00208
Patent 9,808,400 B2
29
and testimony by Mr. Plishka for establishing why an ordinarily skilled
artisan would have considered it obvious to incorporate Peterson’s anti-
reflux device into a catheterization kit. Pet. 57–65 (cross-referencing
argument and evidence relating to Solazzo and Serany and citing Ex. 1036,
1:66–68, 2:46–67, 3:29–39, Figs. 1–4; Ex. 1002 ¶¶ 231–235).
Patent Owner addresses the challenge to claims 13, 14, 16, and 17
based upon Solazzo, Serany, and Peterson in the same way as it addresses
the challenge to those claims based upon Solazzo, Serany, and Boedecker.
PO Resp. 17–36, 40–67. Namely, Patent Owner argues that the combined
teachings of Solazzo and Serany are insufficient to establish obvious without
addressing whether Peterson or Boedecker describe the anti-reflux device of
element 13d.ii. See id.
For the reasons expressed in Part II.E above and for the reasons set
forth by Petitioner explaining why Peterson describes and suggests
incorporating an anti-reflux device into a catheter kit, which we adopt as our
own, we conclude that Petitioner has demonstrated by a preponderance of
evidence that the combined teachings of Solazzo, Serany, and Peterson
render claims 13, 14, 16, and 17 unpatentable as obvious.
G. CLAIMS 13 AND 14:
OBVIOUSNESS IN VIEW OF SOLAZZO, DISSTON, AND BOEDECKER
Petitioner’s challenge based on Solazzo, Disston, and Boedecker
relies upon the same portions of Solazzo and Boedecker as the challenge
analyzed in Part II.E above (“Ground 1”). Pet. 67–74 (cross-referencing
arguments for “Ground 1.”) Petitioner substitutes Disston for Serany as
describing the closed system Foley catheter (element 13d.i) and the physical
arrangement between the coiled tubing and the fluid receptacle (element
13d.iii). Id. at 68–71 (element 13d.i), 74–78 (element 13d.iii). For the
IPR2019-00208
Patent 9,808,400 B2
30
reasons that follow, we conclude that Petitioner has failed to prove by a
preponderance of evidence that the combined teachings of Solazzo, Disston,
and Boedecker describe element 13d.iii.
Disston relates to a single-level, wrapped catheterization tray package
that “provide[s] for the first time a complete, properly organized,
conveniently arranged, sterile set of equipment for catheterization, the entire
drainage system being pre-assembled.” Ex.1008, 2:59–67, Fig. 2. Disston’s
single-level tray 2 contains catheterization devices “arranged in such order
and position as to be most conveniently available when the container is
opened.” Id. at 2:15–23. Disston’s package includes “a pre-assembled
catheter-drainage tube-drip chamber-drainage bag,” id. at 1:33–34, including
a Foley catheter 7, drainage tube 8, drip chamber 9, drainage bag 10, with
“suitable adapters being interposed, if necessary, between the catheter and
tube and/or between the drip chamber and bag,” id. at 2:15–23, Fig. 1.
Based on our review of Disston, we determine that Petitioner fails to
prove by a preponderance of evidence that Disston describes element 13d.iii.
Essentially, Disston fails to describe a coiled tube “such that the fluid
receptacle is between the second compartment base member and the coiled
tube.” Petitioner relies upon Disston’s Figure 1, reproduced below, as
illustrating the claimed arrangement for element 13d.iii.
IPR2019-00208
Patent 9,808,400 B2
31

Disston’s Figure 1 is “a perspective view of the catheter-to bag
assembly, extended in condition for use with the bag temporarily
left in the tray portion of the container from which the sleeve
portion has been removed.” Ex. 1008, 1:49–52.
Figure 1 illustrates Disston’s catheter assembly “extended in condition
for use” but not as arranged before the package is opened. Id.;
Tr. 59:23–60:9. None of Disston’s other figures illustrates the contents of
Disston’s container before opening. See id. Figures 2–4 (failing to illustrate
any contents of Disston’s container). In the “condition for use” shown in
Figure 2, we are unsure of how catheter 7, drainage tube 8, and drainage
bag 10 are arranged inside the compartment of tray 2. Petitioner cites
Disston’s statement that items are “arranged in such order and position as to
be most conveniently available when the container is opened” as proving
that bag 10 is “between the second compartment base member and the coiled
IPR2019-00208
Patent 9,808,400 B2
32
tube” as recited in element 13d.iii. Pet. 75 (citing Ex. 1008, 2:15–23). This
portion of Disston fails, however, to prove by a preponderance of evidence
that Disston’s tubing is coiled as recited in element 13d.iii. Rather, Disston
merely generally states that the items are arranged “to be most conveniently
available when the container is opened.” Petitioner’s citation to
Mr. Plishka’s testimony is also unavailing because Mr. Plishka relies on the
same portion of Disston to opine that “the drainage bag of Disston is
designed to fit in the bottom of a catheter tray, and the coiled tube can be
placed on top of or wrapped around the drainage receptacle.” Id. at 76–77
(citing Ex. 1002 ¶ 278–283 (emphasis added)). Mr. Plishka opines about
how items “can be” placed in Disston’s tray, but he cites no persuasive
evidence that Disston did arrange tubing and a fluid receptacle as required in
element 13d.iii. Based on our careful review of Disston, it is simply too
ambiguous on this point to prove by a preponderance of evidence that it
describes element 13d.iii.
Without persuasive evidence that the combined teachings of Solazzo,
Disston, and Boedecker described element 13d.iii, Petitioner’s argument that
independent claim 13 is unpatentable as obvious fails.
H. CLAIMS 16 AND 17:
OBVIOUSNESS IN VIEW OF SOLAZZO, DISSTON, BOEDECKER, AND SERANY
Claims 16 and 17 depend ultimately from claim 13. Ex. 1001,
12:19–28. Although Petitioner cites Serany as part of the prior art that
renders claims 16 and 17 unpatentable as obvious, Petitioner does not rely
upon Serany as describing element 13d.iii of independent base claim 13.
Pet. 78–79. Accordingly, Petitioner’s challenge to dependent claims 16
and 17 based upon the combined teachings of Solazzo, Disston, Boedecker,
and Serany fails for the same reasons discussed in Part II.F above.
IPR2019-00208
Patent 9,808,400 B2
33
I. CLAIMS 13, 14, 16, AND 17:
OBVIOUSNESS IN VIEW OF SOLAZZO AND NURSING STANDARD
Petitioner’s challenge based on Solazzo and Nursing Standard relies
upon the same portions of Solazzo as the challenge analyzed in Part II.E
above (“Ground 1”). Pet. 81–87 (cross-referencing arguments for
“Ground 1.”) Petitioner relies upon Nursing Standard as suggesting a closed
system Foley catheter (element 13d.i), the incorporation of an anti-reflux
device in the catheter (element 13d.ii), and the physical arrangement
between the coiled tubing and the fluid receptacle (element 13d.iii). Id.
at 82–84 (element 13d.i), 84–85 (element 13d.ii), 85–87 (element 13d.iii).
For the reasons that follow, we conclude that Petitioner has failed to prove
by a preponderance of evidence that the combined teachings of Solazzo and
Nursing Standard describe or suggest element 13d.iii.
Petitioner first argues that arranging “items inside a catheter tray in
their order of use” was “well-known in the art” and references its discussion
of the grounds that we analyze in Parts II.E and II.F above. Pet. 86.
However, we find that Petitioner’s discussion of other grounds that rely on
Serany, Boedecker, and Peterson as secondary references fails to apply in
the context of Petitioner’s challenge based on Solazzo and Nursing Standard.
Accordingly, Petitioner’s cross-reference to other grounds is unpersuasive in
the context of the challenge based solely upon Solazzo and Nursing
Standard.
Petitioner also contends that “a healthcare provider would need access
to the drainage tubing before a fluid receptacle because it is attached to the
Foley catheter. (Ex.1002, ¶316.) Accordingly, it would have been obvious
to arrange a closed-system Foley catheter in the tray of Solazzo” as recited
in element 13d.iii. Id. at 86–87. The only evidence cited to support this
IPR2019-00208
Patent 9,808,400 B2
34
contention is testimony by Mr. Plishka, id. at 87 (citing Ex. 1002 ¶ 316),
who merely parrots the conclusion reached by Petitioner without citing any
objective evidence or explaining how either Solazzo or Nursing Standard
describes element 13d.iii. Ex. 1002 ¶ 316. Patent Owner correctly points
out that Nursing Standard “provides no structural disclosure for a
catheterization tray.” PO Resp. 39 (citing Ex. 2040 ¶¶ 88, 95).
Without persuasive evidence that the combined teachings of Solazzo
and Nursing Standard described or suggested element 13d.iii, Petitioner’s
argument that independent claim 13 is unpatentable as obvious fails.
Accordingly, we determine that Petitioner has failed to carry its burden of
proving that the combined teachings of Solazzo and Nursing Standard render
independent claim 13 or its dependent claims 14, 16, and 17 unpatentable as
obvious.
III. CONCLUSION8
Claims
35
U.S.C. § References
Claims
Shown
Unpatentable
Claims Not
Shown
Unpatentable
13, 14, 16,
17 103
Solazzo, Serany,
Boedecker 13, 14, 16, 17

8 Should Patent Owner wish to pursue amendment of the challenged claims
in a reissue or reexamination proceeding subsequent to the issuance of this
decision, we draw Patent Owner’s attention to the April 2019 Notice
Regarding Options for Amendments by Patent Owner Through Reissue or
Reexamination During a Pending AIA Trial Proceeding. See 84 Fed. Reg.
16,654 (Apr. 22, 2019). If Patent Owner chooses to file a reissue application
or a request for reexamination of the challenged patent, we remind Patent
Owner of its continuing obligation to notify the Board of any such related
matters in updated mandatory notices. See 37 C.F.R. §§ 42.8(a)(3), (b)(2).
IPR2019-00208
Patent 9,808,400 B2
35
Claims
35
U.S.C. § References
Claims
Shown
Unpatentable
Claims Not
Shown
Unpatentable
13, 14, 16,
17 103
Solazzo, Serany,
Peterson 13, 14, 16, 17
13, 14 103 Solazzo, Disston, Boedecker 13, 14
16, 17 103
Solazzo, Disston,
Boedecker,
Serany
16, 17
13, 14, 16,
17 103
Solazzo, Nursing
Standard 13, 14, 16, 17
Overall Outcome 13, 14, 16, 17

IV. ORDER
For the reasons given, it is:
ORDERED, Petitioner has established based on a preponderance of
evidence that claims 13, 14, 16, and 17 of U.S. Patent 9,808,400 B2 are
unpatentable as obvious under 35 U.S.C. § 103; and
FURTHER ORDERED because this is a final written decision, the
parties to this proceeding seeking judicial review of our Decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.
IPR2019-00208
Patent 9,808,400 B2
36
For PETITIONER:
Mehran Arjomand
Cong Luo
MORRISON & FOERSTER LLP
marjomand@mofo.com
cluo@mofo.com

For PATENT OWNER:

Nicholas T. Peters
Paul B. Henkelmann
Allen E. Hoover
FITCH, EVEN, TABIN & FLANNERY LLP
NtPete@fitcheven.com
PHenkelmann@fitcheven.com
AHoover@fitcheven.com

Jeffrey P. Kushan
SIDLEY AUSTIN LLP
jkushan@sidley.com