C.R. Bard, Inc.v.Medline Industries, Inc.

Patent Trial and Appeal Board

Jul 15, 2015

13155026 (P.T.A.B. Jul. 15, 2015)

Trials@uspto.gov Paper 11
571-272-7822 Entered: July 15, 2015

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

C.R. BARD, INC.,
Petitioner,

v.

MEDLINE INDUSTRIES, INC.,
Patent Owner.
____________

Case IPR2015-00509
Patent 8,448,786 B2
____________

Before JOSIAH C. COCKS, JENNIFER MEYER CHAGNON, and
TIMOTHY J. GOODSON, Administrative Patent Judges.

COCKS, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108
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I. INTRODUCTION
C.R. Bard, Inc. (“Petitioner”) filed a Corrected Petition (Paper 7,
“Pet.”) requesting inter partes review of claims 1 and 2 of U.S. Patent No.
8,448,786 B2 (“the ’786 patent”). Medline Industries, Inc. (“Patent Owner”)
timely filed a Preliminary Response (Paper 10, “Prelim. Resp.”) to the
Corrected Petition. We have jurisdiction under 35 U.S.C. § 314.
To institute an inter partes review, we must determine that the
information presented in the Petition shows “a reasonable likelihood that the
petitioner would prevail with respect to at least 1 of the claims challenged in
the petition.” 35 U.S.C. § 314(a). For the reasons set forth below, we
conclude that the information presented in the Petition does not establish a
reasonable likelihood that Petitioner will prevail in challenging claims 1 and
2 of the ’786 patent. We do not authorize an inter partes review to be
instituted as to claims 1 and 2.
A. Related Matters
The ’786 patent is the subject of litigation between the parties in the
U.S. District Court for the Northern District of Illinois, Medline Industries,
Inc. v. C.R. Bard, Inc., Case No. 1:14-cv-03618. See Paper 4, 2. In addition,
three other petitions for inter partes review involving the same parties and
related U.S. Patent Nos. 8,631,935 B2 and 8,678,190 B2 currently are
pending as IPR2015-00511, IPR2015-00513, and IPR2015-00514. See id. at
2–3.
B. The ’786 Patent (Ex. 1001)
The ’786 patent is titled “Catheter Tray, Packaging System,
Instruction Insert, and Associated Methods.” Ex. 1001, Title. The ’786
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patent describes tray 100 that holds catheter assembly 700 as well as other
items used in catheterization, such as syringes 701, 702 containing sterile
water and lubricating jelly. Id. at Abstract. Figure 1, reproduced below, is a
perspective view of a catheter tray according to an embodiment of the
invention. Id. at col. 2, ll. 20–22.

As shown in Figure 1 above, tray 100 has first compartment 101 for
accommodating syringes, second compartment 102 for accommodating the
catheter assembly, and third compartment 103 for accommodating a
specimen jar. Id. at col. 5, ll. 45–49. The ’786 patent explains that the stair-
stepped contour of first compartment base member 107 allows first
compartment 101 to be used as a lubricant applicator for the catheter. Id. at
col. 7, ll. 20–23. Specifically, a medical services provider dispenses
lubricating jelly along second step portion 117, which serves as a channel in
which the lubricating jelly can spread. Id. at col. 7, ll. 24–28. The provider
then passes the catheter through opening 121 between first and second
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compartments 101, 102, through the channel formed by second step portion
117, and out the top of tray 100 to the patient. Id. at col. 6, ll. 47–50; col. 7,
ll. 28–32. According to the ’786 patent, this ability to apply lubricating jelly
to the catheter while the catheter is contained within tray 100 improves on
prior art solutions in both ease of use and reduced risk of contamination. Id.
at col. 7, ll. 33–35, 56–62.
Figure 10, reproduced below, is a perspective view of a tray with a
catheter and other devices disposed therein, along with instructions and
packaging. Id. at col. 2, ll. 50–54.

As shown in Figure 10, tray 100 is sealed with Central Sterile
Reprocessing (CSR) wrap 1000, which can be unfolded and used in the
catheter insertion process, such as by providing a sterile field for tray 100 to
sit in. Id. at col. 10, ll. 13–33. The ’786 patent discloses that printed
instructions 1001, including a health services portion and a patient portion,
can be attached to tray 100. Id. at col. 9, ll. 34–38. The health services
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portion of printed instructions 1001 can provide instructions to health
services providers regarding use of the contents of tray 100. Id. at col. 9,
ll. 38–47. The patient portion of printed instructions 1001 can provide
information that is useful for a patient, and it can be detachable from the
health services portion so that the provider can detach it and discuss its
contents with the patient. Id. at col. 10, ll. 48–63.
C. Illustrative Claims
Claim 1 is independent. Claim 2 depends from claim 1. Claims 1 and
2 are reproduced below:
1. A method of using a catheter package assembly, comprising:
opening a thermally sealed bag disposed about a tray
having a catheter assembly disposed therein;
accessing an instruction manual;
unfolding one or more layers of wrap to reveal an
additional layer of wrap and the catheter assembly; and
placing one of the one or more layers of wrap or the
additional layer of wrap beneath a patient, thereby transforming
an area beneath the patient from a non-sterile field to a sterile
field.

2. The method of claim 1, wherein the instruction manual
comprises a health care services portion and a patient portion
detachably coupled thereto.
Ex. 1001, col. 26, l. 61–col. 27, l. 7.

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D. References Relied Upon
The Petition relies on the following references:
Serany US 3,329,261 July 4, 1967

Ex. 1008
Brezette US 3,978,983 Sept. 7, 1976

Ex. 1010
Franks-Farah US 6,840,379 B2 Jan. 11, 2005 Ex. 1009

EUROPEAN COMMISSION: PHARMACEUTICAL COMMITTEE,
A Guideline on the Readability of the Label and Package
Leaflet of Medicinal Products for Human Use (Sept. 29,
1998) (“1998 EC Guideline”).
Ex. 1007

E. Alleged Grounds of Unpatentability
Petitioner contends that claims 1 and 2 of the ’786 patent are
unpatentable on the following grounds under 35 U.S.C. (see Pet. 13):
References Basis Claims Challenged
Serany § 102/§ 103 1
Serany and Franks-Farah § 103 1
Serany, Franks-Farah, and Brezette § 103 1
Any of the above grounds taken with
1998 EC Guideline
§ 103 2

In support of its proposed grounds of unpatentability, Petitioner also
relies upon the Declaration testimony of Dr. Robert Kimmel (Ex. 1002) and
Ms. Susan Carrow (Ex. 1004).
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II. ANALYSIS
A. Claim Construction
In an inter partes review, claim terms in an unexpired patent are given
their broadest reasonable construction in light of the specification of the
patent in which they appear. 37 C.F.R. § 42.100(b); In re Cuozzo Speed
Techs., LLC, No. 2014–1301, ___ F.3d ___, 2015 WL 2097949, at *5–*8
(Fed. Cir. July 8, 2015). Under the broadest reasonable construction
standard, claim terms usually are given their ordinary and customary
meaning, as would be understood by one of ordinary skill in the art in the
context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249,
1257 (Fed. Cir. 2007). For purposes of this Decision, we need only make
explicit the meaning of the term “reveal.” No other terms require express
construction.
Claim 1 includes the following step: “unfolding one or more layers of
wrap to reveal an additional layer of wrap and the catheter assembly.”
Ex. 1001, col. 26, ll. 66–67 (emphasis added). Petitioner does not offer a
construction of the term “reveal.” Patent Owner proposes a construction of
the term, in the context of its use in claim 1, as “[t]o make visible or to make
(something that was hidden) able to be seen.” Prelim. Resp. 12. As noted
by Patent Owner, the term “reveal” is used throughout the Specification of
the ’786 patent. Id. at 12–13. For instance, the ’786 patent describes the
following:
The top of tray 100 could have a hinged or snap-coupled lid
that is opened or removed to reveal the compartments there
beneath. [Ex. 1001, col. 5, ll. 14–17.]
***
Using a CSR wrap as an illustrative example, in one
embodiment as indicated in FIG. 10, the CSR wrap 100 is
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folded about the tray 100 for sealing, and can be
correspondingly unfolded to reveal the tray 100.
[Id. at col. 10, ll. 25–28.]
***
Where the catheter package assembly is configured as shown in
FIG. 10, removal of the sterile wrap (1002) will reveal the
printed instructions (1001). [Id. at col. 25, ll. 13–15.]
***
At FIG. 31, a health care services provider 3101 opens the outer
bag 2902 that is disposed about the tray 100 and removes the
bag 2902 to reveal the packaged catheter assembly 2901
therein. [Id. at col. 26, ll. 5–8.]
***
Where an additional layer of wrap material 2701 is included,
this unfolding step reveals and makes accessible the additional
layer of wrap material 2701. [Id. at col. 26, ll. 13–16.]
In light of the content of the Specification of the ’786 patent,
including those portions reproduced above, Patent Owner contends that “[i]t
is clear from these disclosures that ‘reveal’ means that an object is made
visible, and particularly something that was hidden is able to be seen,” and
that such meaning constitutes the “plain meaning” of the term. Prelim.
Resp. 13. It is apparent from the ’786 patent, including those portions
reproduced above, that the term “reveal” connotes an action distinct from
making an object accessible. In reviewing the ’786 patent, we discern that,
consistent with the meaning offered by Patent Owner, an object that is
“revealed” becomes exposed visibly upon removal of another component.
We also observe that in looking to other definition sources for the term
“reveal” as it is used in the claims of the’786 patent, the meaning of the term
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is understood commonly as “to show (something) plainly or clearly : to
make (something that was hidden) able to be seen.”
1

In considering the record before us, we are satisfied that the
construction of “reveal” proffered by Patent Owner as “[t]o make visible or
to make (something that was hidden) able to be seen” (Prelim. Resp. 12) is
the customary meaning of the term.
B. Grounds of Unpatentability Based on Serany
Petitioner proposes three grounds of unpatentability for claim 1, and
one ground of unpatentability for claim 2. Pet. 13. All of the grounds apply
Serany. Furthermore, all of those grounds apply Serany as disclosing the
step in claim 1 of “unfolding one or more layers of wrap to reveal an
additional layer of wrap and the catheter assembly.” Ex. 1001, col. 26,
ll. 66–67.
Serany describes a catheterization package that “provides the
convenience of having all the components arranged in logical step-by-step
order to facilitate the nurse’s or physician’s task.” Ex. 1008, col. 1, ll. 31–
35. In that respect, Serany discloses that “box 10 having an open top with a
tray 12 mounted thereon is enclosed within a wrap 14.” Id. at col. 1, ll. 60–
62. Serany further states the following:
The wrap 14, which may be a piece of sterile absorbent
paper is folded around the box 10 in such a way that a slight tug
on the corner 18 will release the folds so that the wrap may
thereafter be readily spread out on the flat surface on which the
box rests. . . . The wrap when removed from around the box as
described above and flattened out thereunder, serves as a sterile

1
See Reveal Definition, Merriam-Webster.com, http://www.merriam-
webster.com/dictionary/reveal (last accessed July 1, 2015).
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field and work area for the remaining operations to be
described.
Id. at col. 2, ll. 1–20.
Thus, Serany describes generally that wrap 14 is positioned around
box 10 and that the wrap, when removed from the box, may serve as a sterile
field and work area for operation operations. Figure 5 of Serany is
reproduced below:

Figure 5 depicts an exploded view of box 10, after wrap 14 has been
removed, and “showing the relationship of various components included
therewith.” Id. at col. 1, ll. 54–56. Serany further sets forth the following:
Upon removal of the wrap 14, there is exposed a
waterproof underpad 20 which is folded flat and rests on top of
the tray 12 . . . Prepowdered plastic gloves 22 are arranged in a
flat condition beneath the underpad 20 and are exposed when
the latter is removed . . . A fenestrated drape 24 folded flat
beneath the gloves, is removed, unfolded, and placed in
position on the patient.
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Id. at col. 2, ll. 21–32. Thus, Serany describes that underpad 20, gloves 22,
and drape 24 lie underneath one another, respectively. It is underpad 20 that
is exposed upon removal of wrap 14, followed by the exposure of gloves 22
upon removal of underpad 20, with drape 24 residing beneath the gloves.
Figure 6 is reproduced below and depicts yet another component removal
step in which tray 12 is lifted from box 10. See id. at col. 1, ll. 57–58.

As depicted in Figure 6, tray 12 is lifted off of box 10 in which
catheter 48 is retained. Serany explains that tray 12 includes inverted groove
27 adjacent its peripheral edge, which operates to accommodate the upper
edge of box 10. Id. at col. 2, ll. 35–38. Serany also explains that the
purpose of tray 12 is to “rigidify the assembled unit,” and that it does so
through the interconnection of groove 27 with the upper edge of box 10. Id.
at col. 4, ll. 8–14.
Petitioner generally contends that Serany “discloses unfolding the
enclosing wrap to reveal contents of the catheter assembly.” Pet. 35
(emphasis removed). Even assuming, however, that unfolding of wrap 14
does cause some contents of box 10 to be revealed, or become visible, (e.g.,
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underpad 20), the claims require that the “catheter assembly” is revealed
upon unfolding of a layer of wrap. Petitioner equates Serany’s catheter 48
with the required catheter assembly. Pet. 30. Thus, to account for the
claims, it is catheter 48 that must be revealed upon unfolding wrap 14. Yet,
as discussed above, in Serany, even after wrap 14 is unfolded, tray 12 lies
above catheter 48. In that regard, grooves 27 of the tray interface with the
upper edge of box 10, such that the tray covers completely the top opening
of the box. The tray, then, must be removed for exposure of the contents
beneath it. Petitioner offers no explanation as to how the unfolding of wrap
14 amounts to an act of revealing catheter 48.
All of the grounds of unpatentability proposed for claims 1 and 2 of
the ’786 patent rely on Serany as disclosing the pertinent step of unfolding
one or more layers of wrap to reveal the catheter assembly. As discussed
above, Petitioner has not explained adequately how Serany accounts for that
step.
III. CONCLUSION
For foregoing reasons, we are not persuaded that Petitioner has
established a reasonable likelihood of prevailing in its challenges to claims 1
and 2 set forth in the Petition.
IV. ORDER
It is
ORDERED that no inter partes review will be instituted pursuant to
35 USC § 314 as to claims 1 and 2 of the ’786 patent on any grounds of
unpatentability alleged in the Petition.

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PETITIONER:

Richard Giunta
Jason Honeyman
Wolf Greenfield & Sacks, P.C.
RGiunta-PTAB@wolfgreenfield.com
JHoneyman-PTAB@wolfgreenfield.com

PATENT OWNER:

Christopher Campbell
John Mills
Cooley LLP
ccampbell@cooley.com
jmills@cooley.com