C.R. Bard, Inc.v.Medical Components, Inc.

Patent Trial and Appeal Board

Feb 9, 2016

12143377 (P.T.A.B. Feb. 9, 2016)

Trials@uspto.gov Paper No. 9
571.272.7822 Entered: February 9, 2016

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

C.R. BARD, INC.,
Petitioner,

v.

MEDICAL COMPONENTS, INC.,
Patent Owner.
____________

Case IPR2015-01660
Patent 8,257,325 B2
____________

Before LYNNE E. PETTIGREW, DANIEL N. FISHMAN, and
KERRY BEGLEY, Administrative Patent Judges.

BEGLEY, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

C.R. Bard, Inc. (“Petitioner”) filed a Petition requesting inter partes
review of claims 1, 2, 5–13, 15–19, 21, and 22 (collectively, “the challenged
claims”) of U.S. Patent No. 8,257,325 B2 (Ex. 1001, “the ’325 patent”).
Paper 1 (“Pet.”). Medical Components, Inc. (“Patent Owner”) filed a
Preliminary Response to the Petition. Paper 7 (“Prelim. Resp.”).
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Pursuant to 35 U.S.C. § 314(a), an inter partes review may not be
instituted unless “the information presented in the petition . . . and any
response . . . shows that there is a reasonable likelihood that the petitioner
would prevail with respect to at least 1 of the claims challenged in the
petition.” Having considered the Petition and the Preliminary Response, we
determine that the information presented does not show that there is a
reasonable likelihood that Petitioner would prevail in establishing that any of
the challenged claims of the ’325 patent are unpatentable. Therefore, we
deny institution of inter partes review.
I. BACKGROUND
A. THE ’325 PATENT
The ’325 patent discloses a venous access port assembly with a
marking that identifies a characteristic of the port and is visible by X-ray
examination when the port is implanted in a patient. Ex. 1001, [57], 1:40–
44. For example, the port may include the letters “CT,” for “computed
tomography” or “contrast enhanced computed tomography,” to indicate
“power injectable capability,” i.e., that the port is rated for power injection
of a contrast fluid. Id. at 1:59–2:1.
Embodiments of the venous access port disclosed in the ’325 patent
include a housing and a septum. Id. at 2:5–6. One embodiment of the
housing is depicted in Figure 13 and a portion of Figure 11, reproduced
below:
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Figure 11

Figure 13
Figure 11 shows a top view and Figure 13 shows an isometric view of an
embodiment with housing base 28, including well 30 having bottom floor 32
and side walls 34. Id. at 3:24–33, 4:44–57. Housing base 28 also includes
flange 36, which features integrally molded “CT” markings alongside suture
openings 40. Id. at 4:44–57. The “CT” markings are voids in the flange, “as
if cut or punched out of” the flange material. Id. at 4:54–57. If base 28 or
flange 36 is comprised of a metal material, the letters “CT” will be visible by
X-ray examination. Id. at 4:65–5:3. If base 28 is made of a plastic material,
a radiopaque agent or fluid can be applied to the letters “CT,” flange 36, or
base 28 to allow the applied area to be visible by X-ray examination. Id.
at 4:61–65.
B. ILLUSTRATIVE CLAIM
Claims 1, 12, and 17 of the ’325 patent are independent claims. See
id. at 5:11–8:2. Claim 1, reproduced below, is illustrative of the recited
subject matter:
1. A venous access port assembly for implantation into a
patient, comprising:
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a housing comprising a base defining a bottom wall of at
least one reservoir, a discharge port extending from the at
least one reservoir, and a flange adjacent to the at least
one reservoir, the flange comprising a height extending
from a top surface of the flange to a bottom surface of the
flange, the flange further comprising X-ray discernable
indicia configured to indicate, under X-ray examination,
that the port assembly is rated for power injection, the X-
ray discernable indicia located in the flange and
extending through the height of the flange from the top
surface of the flange to the bottom surface of the flange
so that the X-ray discernable indicia are visually
discernable to a naked eye from both the top surface of
the flange and the bottom surface of the flange prior to
implantation of the port assembly; and
a needle-penetrable septum communicating with the
housing.
Id. at 5:12–30.
C. ASSERTED PRIOR ART
The Petition relies upon the following references, as well as the
supporting Declaration of Steven J. Tallarida (Ex. 1009):
U.S. Patent No. 6,826,257 B2 (issued Nov. 30, 2004) (Ex. 1007,
“Sayre”);
U.S. Patent No. 7,785,302 B2 (filed Mar. 6, 2006) (issued Aug. 31, 2010)
(Ex. 1003, “Powers”);
French Patent No. 1,509,165 (issued Dec. 4, 1967) (published Jan. 12,
1968) (Ex. 1005, “Meyer”);1
BARD ACCESS SYSTEMS, HICKMAN® SUBCUTANEOUS PORTS &
HICKMAN®/BROVIAC® CATHETERS (1992) (Ex. 1017, “Hickman”);

1 Petitioner submitted the original version of Meyer, a French patent, as
Exhibit 1005 and, as required under 37 C.F.R. § 42.63(b), a certified English
translation of the patent as Exhibit 1006. For purposes of this decision, our
citations to Meyer are to the certified English translation.
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BARD ACCESS SYSTEMS, PORTS (2003) (EX. 1002, “PORTS”); and
BARD ACCESS SYSTEMS, POWERPORT: GUIDELINES FOR CT
TECHNOLOGISTS (2007) (Ex. 1004, “PowerPort”).
D. ASSERTED GROUNDS OF UNPATENTABILITY
Petitioner asserts the following grounds of unpatentability. Pet. 3.
Challenged Claims Basis References
1, 2, 5–13, 15–19,
21, and 22
§ 1032 PORTS, Powers, PowerPort,
and Hickman
1, 2, 5–13, 15–19,
21, and 22
§ 103 PORTS, Powers, Sayre, and
Hickman
1, 2, 5–13, 15–19,
21, and 22
§ 103 PORTS, Powers, Meyer, and
Hickman

II. ANALYSIS
A. CLAIM INTERPRETATION
We interpret claims in an unexpired patent using the “broadest
reasonable construction in light of the specification of the patent in which
[they] appear[].” 37 C.F.R. § 42.100(b). Here, Petitioner proffers claim
terms for construction and argues that all claim terms, including those
proposed for construction, “should be afforded their ordinary and customary
meanings.” Pet. 4–6. In response, Patent Owner “reserves the right to
challenge Petitioner’s asserted claim constructions” but does not proffer a
construction of any term. Prelim. Resp. 7. For purposes of this decision, we
determine that none of the claim terms requires an express construction to
resolve the issues currently presented by the patentability challenges. See
Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir.

2 The Leahy Smith America Invents Act (“AIA”), Pub. L. No. 112–29, 125
Stat. 284 (2011), revised 35 U.S.C. § 103, effective March 16, 2013.
Because the ’325 patent has an effective filing date before March 16, 2013,
our references to § 103 are to its pre-AIA version.
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1999) (holding that only claim terms that “are in controversy” need to be
construed and “only to the extent necessary to resolve the controversy”).
B. OBVIOUSNESS OVER PORTS, POWERS, POWERPORT, AND HICKMAN
We turn to Petitioner’s assertion that the challenged claims would
have been obvious over the combination of PORTS, Powers, PowerPort, and
Hickman. Pet. 27–50.
1. PORTS
PORTS is a Bard Access Systems brochure that discloses several
implanted ports, including a Titanium Implanted Port. Ex. 1002, 10, 16.
The following figure from page 10 of PORTS illustrates the Titanium
Implanted Port:

Id. at 10. As shown in the figure above, the Titanium Implanted Port
includes a “silicone-encapsulated base” and a “[s]ilicone septum.” Id. The
base includes a flange with “[s]uture slots and orientation holes [that]
simplify implantation and promote port securement.” Id.
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2. Powers
Powers describes an access port with a feature structured to identify
the port as being rated for power injection after subcutaneous implantation.
Ex. 1003, [57], 1:66–2:2, 3:60–64, 11:55–12:2. Figures 52A and 52B of
Powers illustrate a top and bottom perspective view of an embodiment of an
access port with an alphanumeric message in the bottom:

See id. at 3:17–21. The port shown in Figures 52A and 52B includes the
letters “CT” etched in disk or plate 120 in the bottom of the port to identify
the port as power injectable. Id. at 3:48–52, 4:8–10, 11:55–61. Powers
explains that the plate may be metal such that the alphanumeric message
would be visible on an X-ray. Id. at 11:55–58; see id. at 11:66–12:2.
3. PowerPort
PowerPort is a one-page sheet with guidelines for computed
tomography (“CT”) technologists using Bard Access Systems’ PowerPort
implanted port, which is “indicated for power injection of contrast media”
when used with another product. Ex. 1004. One of the ports disclosed in
PowerPort is the PowerPort - M.R.I. Device, shown in the following image:
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Id. The image above appears to show the PowerPort - M.R.I. Device under
X-ray examination, with the characters “C” and “T” formed as voids. See
id.
4. Hickman
Hickman is a Bard Access Systems chart providing information about
various subcutaneous ports and catheters. Ex. 1017. A portion of a figure
from Hickman depicting a Hickman® subcutaneous port is reproduced
below:

Id. at 1, 4. The image above illustrates a cutaway of a Hickman®
subcutaneous port. Id.
5. Discussion
i. Independent Claim 1
Beginning with independent claim 1 of the ’325 patent, Petitioner
contends that the combination of PORTS and Powers teaches all of the
recited limitations. Pet. 27–34. Petitioner cites to the additional asserted
prior art references, PowerPort and Hickman, only for emphasis or
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confirmation of particular aspects of the proposed combination. Id. at 28,
32–33. Specifically, Petitioner cites to Hickman to “confirm[] that the
Titanium Implanted Port disclosed in PORTS has a base defining a
reservoir,” as claim 1 requires. Id. at 27–28. Likewise, Petitioner refers to
PowerPort to “emphasize[] the obviousness” of the limitation reciting “the
flange further comprising X-ray discernable indicia configured to indicate,
under X-ray examination, that the port assembly is rated for power
injection.” Id. at 27, 33.
Patent Owner disputes Petitioner’s showing regarding “the flange
further comprising X-ray discernable indicia configured to indicate, under
X-ray examination, that the port assembly is rated for power injection,” as
recited in claim 1. Prelim. Resp. 7–30, 38. For this limitation, Petitioner
asserts that the flange of the Titanium Implanted Port of PORTS is
composed of titanium, an X-ray discernable material, and includes suture
slots and orientation holes. Pet. 28, 30–33; see Ex. 1009 ¶¶ 59–60, 68–69.
In addition, Petitioner cites Powers for its disclosure of a power injectable
port with an alphanumeric message that, under X-ray examination, indicates
that the port is rated for power injection. Pet. 29. Petitioner also alleges that
Powers discloses that suture apertures may be positioned so as to identify the
port after subcutaneous implantation. Id. Moreover, Petitioner cites
PowerPort for disclosing the PowerPort - M.R.I. Device with the characters
“C” and “T” formed as voids to identify the port as rated for power injection
under X-ray examination. Id. at 29–30. Notably, Petitioner does not
contend that either Powers or PowerPort discloses X-ray discernable indicia
in a flange, as claim 1 requires. See id. at 28–33.
Petitioner proceeds to argue that it would have been obvious to
combine these teachings to reach the venous access port assembly of
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claim 1. See id. at 31–34. Acknowledging that the Titanium Implanted Port
of PORTS is not power injectable and does not have indicia indicating “the
[port] assembly is rated for power injection,” as claim 1 requires, Petitioner
argues that a person of ordinary skill in the art at the time of the invention
would have known that the Titanium Implanted Port of PORTS “could be
constructed to handle power injection.” Id. at 31. Specifically, according to
Petitioner, “the Titanium Implanted Port would be modified in view of
Powers to handle the higher pressure and flow rates associated with power
injection for injecting contrast media.” Id. (citing Ex. 1009 ¶¶ 147–48).
Then, according to Petitioner, it would have been obvious to provide
the Titanium Implanted Port, modified to handle power injection, with X-ray
discernable indicia to indicate, under X-ray examination, that the assembly
is rated for power injection, particularly in view of the ports disclosed in
Powers and PowerPort with X-ray discernable alphanumeric messages
indicating that they are rated for power injection. Id. at 31–33. Next,
Petitioner contends that it would have been obvious to form such X-ray
discernable indicia as voids extending through the flange of the Titanium
Implanted Port of PORTS because the flange of the Titanium Implanted Port
already includes suture slots and orientation holes that function as indicia of
orientation under X-ray examination. Id. Petitioner submits that the
obviousness of including X-ray discernable indicia in the form of voids in
the flange of the Titanium Implanted Port of PORTS is “emphasized” by
PowerPort’s disclosure of X-ray discernable alphanumeric characters in the
form of voids indicating that a port is power injectable. Id. at 33.
Patent Owner’s primary contention in its Preliminary Response is that
the Petition fails to provide adequate reasoning for combining the references
in the manner asserted in the Petition. See Prelim. Resp. 7–31, 38. Having
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reviewed both parties’ arguments and evidence, we agree with Patent Owner
that Petitioner has not articulated sufficient rationale with support in the
record for modifying the Titanium Implanted Port of PORTS as proposed in
the Petition. In particular, we are persuaded by the following arguments
presented by Patent Owner.
First, we agree with Patent Owner that the Petition does not provide
adequate reasoning with rational underpinning for why it would have been
obvious in view of Powers to modify the Titanium Implanted Port of
PORTS—which Petitioner does not allege is indicated for power injection—
to be rated for power injection. See id. at 8–11; Pet. 24–25, 31. Although
claim 1 does not require the recited port assembly to be rated for power
injection, modifying the Titanium Implanted Port to handle power injection
is an important first step in Petitioner’s obviousness analysis. See Pet. 31.
Specifically, as noted above, Petitioner contends that a person of ordinary
skill in the art would have known that the Titanium Implanted Port “could be
constructed to handle power injection” by modifying it “in view of Powers
to handle the higher pressures and flow rates associated with power
injection.” Id. (citing Ex. 1009 ¶¶ 147–48).
This assertion, however, is conclusory, and relies exclusively on
Mr. Tallarida’s declaration testimony, which merely repeats the conclusory
statements in the Petition without citation to the asserted prior art references
or any other evidence. See id.; Ex. 1009 ¶ 148. Accordingly, his testimony
has little, if any, probative value. See 37 C.F.R. § 42.65(a) (“Expert
testimony that does not disclose the underlying facts or data on which the
opinion is based is entitled to little or no weight.”); see Rohm & Haas Co. v.
Brotech Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997) (“Nothing in the
[federal] rules [of evidence] or in our jurisprudence requires the fact finder
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to credit the unsupported assertions of an expert witness.”). The Petition and
Mr. Tallarida’s cited testimony do not explain how the Titanium Implanted
Port of PORTS would have been modified so as to be rated for power
injection, nor do they point to any disclosure in Powers that would have
suggested how such a modification would have been made. See Pet. 31;
Ex. 1009 ¶ 148.
Second, we also find persuasive certain aspects of Patent Owner’s
argument that the Petition fails to explain sufficiently why it would have
been obvious to modify the flange of the Titanium Implanted Port of PORTS
to have X-ray discernable indicia in the form of voids configured to indicate
that the port assembly is rated for power injection, as alleged in the Petition.
See Prelim. Resp. 14–30. In particular, Patent Owner finds fault with
Petitioner’s assertion that the flange of the Titanium Implanted Port has
suture slots and orientation holes that function as indicia of orientation under
X-ray examination, a linchpin of Petitioner’s obviousness analysis. Id.
at 15–16. As Patent Owner points out, PORTS discloses that the function of
the suture slots and orientation holes of the Titanium Implanted Port is to
“simplify implantation and promote port securement.” Ex. 1002, 10; see
Prelim. Resp. 16. Thus, according to Patent Owner, PORTS indicates that
the orientation holes are used to secure orientation of the port, not to provide
X-ray discernable indicia of orientation after implantation. Prelim.
Resp. 15–16.
We agree with Patent Owner that Petitioner has not shown sufficiently
that the suture slots and orientation holes in the flange of the Titanium
Implanted Port of PORTS function as X-ray discernable indicia. Petitioner
does not direct us to any specific disclosure in PORTS describing the suture
slots or orientation holes as X-ray discernable after implantation. See
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Pet. 18–19, 31–32, 36. Furthermore, Mr. Tallarida’s testimony that the
flange of the Titanium Implanted Port is known as a location for X-ray
discernable indicia is conclusory and lacks adequate explanation and
support. See, e.g., Ex. 1009 ¶¶ 64–65, 150, 157, 159, 163, 183. The only
supporting citation Mr. Tallarida provides for this testimony is to the entirety
of PORTS, a seventeen-page exhibit. E.g., id. ¶¶ 65, 157 (citing Ex. 1002).
Consequently, his testimony on this point is entitled to little or no weight.
See 37 C.F.R. § 42.65(a).
In addition, we agree with Patent Owner that Petitioner has not
provided adequate reasoning based on Powers and PowerPort for modifying
the Titanium Implanted Port of PORTS to include X-ray discernable indicia
of power injection capability in the flange. See Prelim. Resp. 23–29.
Powers discloses an alphanumeric message, indicating power injection
capability under X-ray examination, etched in a disk or plate in the bottom
of a port. Ex. 1003, 11:55–61. The alphanumeric message disclosed in
Powers, however, is not in a flange or in the form of voids. Id. at 11:56–61,
Figs. 52A–B. Petitioner also refers to suture apertures in Powers that may
be positioned so as to identify the access port after implantation. Pet. 29, 32
(citing Ex. 1003, 10:16–18, Fig. 20). Yet Petitioner does not contend that
these apertures are in a flange or are indicia of power injection capability.
See id. Accordingly, we are not persuaded that Petitioner has shown
sufficiently that a person of ordinary skill, in view of Powers, would have
modified the flange of the Titanium Implanted Port to include X-ray
discernable indicia in the form of voids indicating that the port is rated for
power injection, as Petitioner proposes.
Turning to PowerPort, we likewise agree with Patent Owner that
Petitioner has not shown sufficiently that PowerPort provides adequate
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reasoning to modify the flange of the Titanium Implanted Port to include
such indicia. See Prelim. Resp. 26–29. Petitioner does not assert that
PowerPort’s X-ray discernable indicia of power injection capability are
located in a flange. See Ex. 1004; Pet. 20–21, 29–33. Therefore, we are not
persuaded by Petitioner’s argument that PowerPort “emphasize[s]” the
obviousness of including X-ray discernable indicia in the form of voids in
the flange of the Titanium Implanted Port. See Pet. 30–31.
For at least these reasons, Petitioner has not provided adequate
reasoning with rational underpinning for combining the asserted references
to reach the venous access port assembly recited in claim 1. See In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006), quoted with approval in KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007) (holding that the “legal conclusion of
obviousness” must be supported by “some articulated reasoning with some
rational underpinning”).
ii. Independent Claims 12 and 17
Similar to claim 1, independent claim 12 recites a venous access port
assembly that requires a “flange comprising: X-ray discernable material”
and “one or more cutouts comprising one or more voids in the X-ray
discernable material, the one or more cutouts configured to indicate, under
X-ray examination, that the port assembly is rated for power injection.”
Ex. 1001, 5:56–6:5. Likewise, independent claim 17 recites a venous access
port assembly, including a “flange comprising . . . one or more X-ray
discernable indicia configured to indicate, under X-ray examination, that the
port assembly is rated for power injection.” Id. at 6:28–43. Petitioner
contends that the asserted prior art references teach or suggest these
limitations and would have been obvious to combine for largely the same
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reasons presented with respect to the corresponding limitations of claim 1.
See Pet. 39–43, 45–46.
For the reasons discussed above with respect to claim 1, we also
determine that Petitioner has not articulated a sufficient rationale for
combining the references to arrive at the port assembly recited in
independent claims 12 and 17, with a flange configured to indicate, under
X-ray examination, that the assembly is rated for power injection.
Claim 17’s limitations regarding the recited “X-ray discernable indicia” are
nearly identical to those in claim 1. Moreover, claim 12’s requirement of
“one or more cutouts comprising one or more voids in the X-ray discernable
material,” as opposed to the “X-ray discernable indicia” recited in claim 1,
does not alter Petitioner’s proffered analysis in a manner that impacts our
determination that Petitioner has failed to provide adequate reasoning to
combine the references, outlined above for claim 1. See id. at 39–43.
iii. Conclusion
For the foregoing reasons, based on our review of the parties’
arguments and evidence, we conclude that Petitioner has not established a
reasonable likelihood that it would prevail in showing that any of the
challenged claims—independent claims 1, 12, and 17 as well as claims 2, 5–
11, 13, 15, 16, 18, 19, 21, and 22, which depend from these claims—would
have been obvious in view of PORTS, Powers, PowerPort, and Hickman.3

3 Because we conclude Petitioner has not provided sufficient reasoning for
combining the asserted prior art references, we need not address Patent
Owner’s other arguments disputing the sufficiency of Petitioner’s showing
regarding specific claim limitations and evidence that certain references
qualify as printed publications. See Prelim. Resp. 38–54.
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C. OBVIOUSNESS OVER PORTS, POWERS, SAYRE, AND HICKMAN
Petitioner also argues that the combination of PORTS, Powers, Sayre,
and Hickman renders the challenged claims obvious. Pet. 50–54.
1. Sayre
Sayre discloses a marking device for defining the margins and
orientation of radiography specimens removed from a patient’s body.
Ex. 1007, [57]. A distinctively shaped marker composed of radiopaque
material, with indicia “photoetched from the radiopaque material,” is
attached to a specimen to indicate the orientation of the specimen prior to
removal from a patient. Id. at 4:6–10, Figs. 1, 2A–C. Indicia also may be
formed in radiopaque markers “by stamping, laser cutting, or by other
means.” Id. at 4:24–26.
2. Discussion
Petitioner argues that the challenged claims would have been obvious
over PORTS, Powers, Sayre, and Hickman “for the same reasons these
claims would have been obvious” over PORTS, Powers, PowerPort, and
Hickman, “because Sayre, like PowerPort, teaches indicia in the form of
alphanumeric character cutouts (voids).” Pet. 50. In its analysis, Petitioner
replaces PowerPort with Sayre, arguing that “[t]he obviousness of including
X-ray discernable indicia in the form of cutouts (voids) in the flange of the
Titanium Implanted Port” of PORTS “is emphasized by Sayre’s disclosure
of X-ray discernable indicia, such as alphanumeric characters, defined by
apertures (voids) in radiopaque material that can also aid in indicating
orientation and receive sutures.” Id. at 52.
For substantially the same reasons discussed above with respect to the
asserted ground relying on PORTS, Powers, PowerPort, and Hickman,
Petitioner has not provided adequate reasoning based on rational
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underpinnings for combining the references to arrive at the claimed
invention. With regard to Sayre, we agree with Patent Owner that Petitioner
has not shown that Sayre cures the deficiencies of PORTS and Powers. See
Prelim. Resp. 31–34. In particular, Sayre’s radiopaque indicia are not in a
flange, much less in a flange of a venous access port. See Ex. 1007, [57],
Figs. 2A–C. Therefore, we are not persuaded by Petitioner’s argument that
Sayre “emphasize[s]” the obviousness of including X-ray discernable indicia
in the form of cutouts or voids in the flange of the Titanium Implanted Port
of PORTS. See Pet. 50–52.
Thus, we determine the Petition does not show a reasonable likelihood
that Petitioner would prevail in showing that any of the challenged claims
would have been obvious over PORTS, Powers, Sayre, and Hickman.
D. OBVIOUSNESS OVER PORTS, POWERS, MEYER, AND HICKMAN
In addition, Petitioner asserts that the challenged claims would have
been obvious over PORTS, Powers, Meyer, and Hickman. Id. at 54–59.
1. Meyer
Meyer discloses a plastic collar for a container with characters used
for identification or inspection purposes. Ex. 1006, 2 (col. 1–2), 3 (col. 1).
In one embodiment, characters “are formed by cutouts in the body of the
collar.” Id. at 3 (col. 1).
2. Discussion
Petitioner argues that the challenged claims would have been obvious
over PORTS, Powers, Meyer, and Hickman “for the same reasons that these
claims would have been obvious” over PORTS, Powers, PowerPort, and
Hickman as well as over PORTS, Powers, Sayre, and Hickman, because
“Meyer, like PowerPort and Sayre, teaches indicia in the form of
alphanumeric characters (voids).” Pet. 55. Similar to the ground based in
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part on Sayre, Petitioner essentially replaces PowerPort with Meyer in its
analysis, arguing that the obviousness of including X-ray discernable indicia
in the form of voids in the flange of the Titanium Implanted Port is
“emphasized by Meyer in its disclosure of indicia in the form of
alphanumeric cutouts (voids) in a flange adjacent to a container.” Id. at 57.
For substantially the same reasons discussed above with respect to the
asserted ground based on PORTS, Powers, PowerPort, and Hickman,
Petitioner has not provided adequate reasoning with rational underpinning
for combining PORTS, Powers, Meyer, and Hickman to arrive at the
invention recited in the challenged claims. We agree with Patent Owner that
Petitioner has not shown that Meyer cures the deficiencies of PORTS and
Powers. See Prelim. Resp. 35–37. Petitioner alleges that the alphanumeric
cutouts in the plastic collar of Meyer would be visible under X-ray
examination, yet neither Meyer nor the cited paragraphs from
Mr. Tallarida’s declaration testimony sufficiently support this assertion,
particularly in light of contradictory evidence in the record. See Pet. 55
(citing Ex. 1006; Ex. 1009 ¶¶ 278–84); see also Ex. 1009 ¶ 193 (opining that
silicone is radiotransparent); Ex. 1001, [57], 2:13–17, 4:61–5:3 (explaining
that radiopaque agent can be applied to plastic material, such as silicone
elastomer, to allow indicia to appear under X-ray examination). Moreover,
even if the collar in Meyer can be considered a flange,4 it is not a flange of
anything resembling a venous access port. Petitioner also has not shown
adequately that Meyer, which discloses collars for containers, is “from the
same field of endeavor” or “reasonably pertinent to the particular problem”

4 We note that Meyer’s collar does not meet Petitioner’s proffered
construction of the term “flange,” “a rim extending outwardly from the base
for attachment of the port to a patient.” Pet. 5; see Prelim. Resp. 36.
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addressed by the inventors of the ’325 patent in developing the venous
access ports recited in the challenged claims, as required to be prior art
under 35 U.S.C. § 103. Innovention Toys, LLC v. MGA Entm’t, Inc., 637
F.3d 1314, 1321 (Fed. Cir. 2011) (quoting In re Bigio, 381 F.3d 1320, 1325
(Fed. Cir. 2004)); see Ex. 1006, 3 (Summary); Prelim. Resp. 35. Therefore,
we are not persuaded by Petitioner’s argument that Meyer “emphasize[s]”
the obviousness of including X-ray discernable indicia in the form of cutouts
or voids in the flange of the Titanium Implanted Port of PORTS. See
Pet. 57.
Accordingly, we determine that the Petition does not show a
reasonable likelihood that Petitioner would prevail in showing that any of
the challenged claims would have been obvious over PORTS, Powers,
Meyer, and Hickman.
E. REAL PARTY-IN-INTEREST
Patent Owner argues in its Preliminary Response that the Petition
should have named Bard Access Systems, Inc. as a real party-in-interest in
addition to C.R. Bard, Inc. Prelim. Resp. 54–59. In view of our
determination that Petitioner has not made a sufficient showing that it would
prevail in establishing that any of the challenged claims are unpatentable, we
do not reach this issue.
III. CONCLUSION
For the reasons given, we determine that the information presented in
the Petition and Preliminary Response does not establish that there is a
reasonable likelihood that Petitioner would prevail in showing that any of
the challenged claims, claims 1, 2, 5–13, 15–19, 21, and 22 of the
’325 patent, are unpatentable. Therefore, we do not institute inter partes
review of any of the challenged claims on any of the asserted grounds.
IPR2015-01660
Patent 8,257,325 B2
20

IV. ORDER
Accordingly, it is:
ORDERED that pursuant to 35 U.S.C. § 314(a), the Petition is denied.
IPR2015-01660
Patent 8,257,325 B2
21

PETITIONER:
Michael J. Fink
Arnold Turk
GREENBLUM & BERNSTEIN, P.L.C.
1950 Roland Clarke Place
Reston, VA 20191
mfink@gbpatent.com
aturk@gbpatent.com

PATENT OWNER:
Alfred W. Zaher
Jonathan R. Bowser
Roger H. Lee
Shawn Li
BUCHANAN INGERSOLL & ROONEY PC
Two Liberty Place 50 S. 16th Street, Suite 3200
Philadelphia, PA 19102-2555
Alfred.Zaher@bipc.com
Jon.Bowser@bipc.com
Roger.Lee@bipc.com
Shawn.Li@bipc.com