throbber
Trials@uspto.gov
`571.272.7822
`
`
`Paper No. 9
`
` 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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`IPR2015-01660
`Patent 8,257,325 B2
`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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`IPR2015-01660
`Patent 8,257,325 B2
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`
`
`Figure 13
`Figure 11
`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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`IPR2015-01660
`Patent 8,257,325 B2
`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
`housing.
`Id. at 5:12–30.
`
`the
`
`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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`IPR2015-01660
`Patent 8,257,325 B2
`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,
`§ 1032 PORTS, Powers, PowerPort,
`21, and 22
`and Hickman
`1, 2, 5–13, 15–19,
`§ 103 PORTS, Powers, Sayre, and
`21, and 22
`Hickman
`1, 2, 5–13, 15–19,
`§ 103 PORTS, Powers, Meyer, and
`21, and 22
`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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`IPR2015-01660
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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
`17
`
`
`
`

`
`IPR2015-01660
`Patent 8,257,325 B2
`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.
`18
`
`
`
`

`
`IPR2015-01660
`Patent 8,257,325 B2
`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.
`19
`
`
`
`

`
`IPR2015-01660
`Patent 8,257,325 B2
`
`IV. ORDER
`
`
`
`
`Accordingly, it is:
`ORDERED that pursuant to 35 U.S.C. § 314(a), the Petition is denied.
`
`
`
`20
`
`

`
`IPR2015-01660
`Patent 8,257,325 B2
`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
`
`
`
`
`
`21

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