Filed on behalf of Patent Owner
`By:
`
`Alfred W. Zaher, Esq.
`Shawn S. Li, Esq.
`BUCHANAN INGERSOLL & ROONEY PC
`Two Liberty Place
`50 S. 16th Street, Suite 3200
`Philadelphia, PA 19102-2555
`Telephone: (215) 665-8700
`Facsimile: (215) 665-8760
`alfred.zaher@bipc.com
`shawn.li@bipc.com
`
`Roger H. Lee, Esq.
`Jonathan R. Bowser, Esq.
`BUCHANAN INGERSOLL & ROONEY PC
`1737 King Street, Suite 500
`Alexandria, VA 22314-2727
`Telephone (703) 836-6620
`Facsimile (703) 836-2021
`roger.lee@bipc.com
`jon.bowser@bipc.com
`
`
`
`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 No. IPR2015-01660
`Patent 8,257,325
`____________________
`
`PATENT OWNER’S PRELIMINARY RESPONSE TO THE PETITION
`FOR INTER PARTES REVIEW FOR U.S. PATENT NO. 8,257,325
`PURSUANT TO 35 U.S.C. § 313 AND 37 C.F.R. § 42.107
`
`
`
`
`
`

`
`TABLE OF CONTENTS
`
`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
`
`
`
`Page
`
`I.
`
`
`II.
`
`
`INTRODUCTION ........................................................................................... 1
`
`BACKGROUND OF THE ‘325 PATENT ..................................................... 3
`
`A.
`
`
`B.
`
`
`Background of the ‘325 Patent .............................................................. 3
`
`The ‘325 Patent Provides a Port Assembly Having X-Ray
`Discernable Indicia or Cutouts in the Flange Configured to Indicate
`that the Assembly is Rated for Power Injection .................................... 4
`
`
`
` CLAIM CONSTRUCTION ............................................................................ 6 III.
`
`
`
` ARGUMENT ................................................................................................... 7 IV.
`
`A.
`
`
`The Petition Fails to Provide Adequate Reasoning for Combining
`the Alleged Prior Art ............................................................................. 7
`
`1.
`
`It Would Not Have Been Obvious to Modify Titanium
`Implanted Port of PORTS to Be Rated for Power Injection ....... 8
`
` Mr. Tallarida Provides No Underlying Facts or Data a.
`
`
`to Support His Conclusions .............................................. 8
`
`b.
`
`
`PowerPort Provides Evidence that It Would Not Have
`Been Obvious to Modify Titanium Implanted Port to
`Be Rated for Power Injection .........................................11
`
`2.
`
`It Would Not Have Been Obvious to Modify the Flange of
`PORTS to Have X-ray Discernable Indicia or Cutouts
`Configured to Indicate that the Assembly is Rated for Power
`Injection ....................................................................................14
`
`a.
`
`
`b.
`
`
`The Orientation Holes of PORTS Are for Securing the
`Orientation of the Port, Not for Providing Indicia of
`Orientation under X-ray Examination ............................15
`
`Petitioner Admitted that the Use of Indicia in the
`Form of Voids Would Compromise the Structural
`Integrity of the Port .........................................................19
`
`i
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`

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`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
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`c.
`
`
`d.
`
`
`It Would Not Have Been Obvious to Add Alphanumeric
`Voids to the Flange in Light of the Suture Slots and
`Orientation Holes Already Present in the Flange ...........21
`
`The Indicia for Indicating that the Port is Rated for
`Power Injection Taught by Powers Are Not Voids or
`Cutouts in the Flange ......................................................23
`
`3.
`
`PowerPort, Meyer, Sayre, and Hickman Do Not Cure the
`Above-described Deficiencies of PORTS and Powers .............26
`
`a.
`
`
`PowerPort Does Not Provide Adequate Reasoning for
`Modifying the Flange of PORTS to Have X-ray
`Discernable Indicia or Cutouts .......................................26
`
`i.
`
`
`ii.
`
`
`iii.
`
`
`Contrary to Mr. Tallarida’s Testimony,
`PowerPort Does Not Disclose that the Voids
`Are Formed in Titanium .......................................26
`
`The “CT” Indicia of PowerPort Is Not in the
`Flange Even under Petitioner’s Construction ......27
`
`PowerPort Teaches Using Palpation Bumps
`and a Triangular Port Housing as Means for
`Determining Whether an Implanted Port is
`Power Rated, Not X-ray Discernable Voids or
`Cutouts in the Flange ............................................30
`
`b.
`
`
`Sayre Does Not Provide Adequate Reasoning for
`Modifying the Flange of PORTS to Have X-ray
`Discernable Indicia or Cutouts .......................................31
`
`i.
`
`
`ii.
`
`
`The Indicia Disclosed by Sayre Is Not in a
`Flange Even Under Petitioner’s Construction .....31
`
`Petitioner Provides No Reason with Rational
`Underpinnings for Modifying PORTS in View
`of Sayre .................................................................33
`
` Meyer Does Not Provide Adequate Reasoning for c.
`
`
`Modifying the Flange of PORTS to Have X-ray
`Discernable Indicia .........................................................35
`
`ii
`
`

`
`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
`
`i.
`
`
`ii.
`
`
`iii.
`
`
`Petitioner Has Not Established that the Plastic
`Collar of Meyer is Radiopaque ............................35
`
`The Collar Disclosed by Meyer is Not a Flange
`Even Under Petitioner’s Construction .................36
`
`Petitioner’s Modification Would Defeat Meyer’s
`Stated Purpose of the Plastic Collar Which Is to
`Avoid the Use of Metal ........................................37
`
`d.
`
`
`Hickman Does Not Cure the Above-described
`Deficiencies of the Other Alleged Prior Art ...................38
`
`B.
`
`
`The Petition Fails to Address All of the Elements of the Challenged
`Claims of the ‘325 Patent ....................................................................38
`
`1.
`
`2.
`
`3.
`
`The Petition Fails to Specify Where PORTS Discloses a
`Flange “comprising…X-ray discernable indicia” and a
`“flange comprising…X-ray discernable material” ...................39
`
`The Petition Fails to Specify Where PORTS Discloses a
`“flange…comprised of a metal material” .................................41
`
`The Petition Fails to Specify Where the Alleged Prior Art
`Discloses that “the indicia are located within predetermined
`suture openings” ........................................................................42
`
`C.
`
`
`Petitioner’s Alleged Evidence Does Not Establish that PORTS,
`PowerPort, and Hickman Are Prior Art ..............................................43
`
`1.
`
`Petitioner’s Alleged Evidence Does Not Establish that PORTS
`Is a Printed Publication .............................................................44
`
` Mr. Blaber’s Unsupported Testimony Concerning the a.
`
`
`Alleged Distribution of PORTS Should Be Given No
`Weight .............................................................................45
`
` Mr. Blaber’s Unsupported Testimony Concerning the b.
`
`
`Alleged Availability of PORTS on the Bard Website
`Should Be Given No Weight ..........................................46
`
`iii
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`

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`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
`
` Mr. Blaber’s Unsupported Testimony Concerning the c.
`
`
`Alleged Standard Practices at Bard Should Be Given
`No Weight .......................................................................48
`
`2.
`
`Petitioner’s Alleged Evidence Does Not Establish that
`PowerPort Is a Printed Publication ...........................................49
`
` Ms. Boswell’s Unsupported Testimony Concerning the a.
`
`
`Alleged Distribution of PowerPort Should Be Given
`No Weight .......................................................................49
`
` Ms. Boswell’s Unsupported Testimony Concerning the b.
`
`
`Alleged Standard Practices at Bard Should Be Given
`No Weight .......................................................................51
`
`3.
`
`Petitioner’s Alleged Evidence Does Not Establish that
`Hickman Is a Printed Publication .............................................53
`
`D.
`
`
`The Petition Does Not Name All Real Parties-In-Interest ..................54
`
`1.
`
`2.
`
`3.
`
`Applicable Standards for Determining RPI ..............................54
`
`Bard Access Systems, Inc. is an RPI ........................................56
`
`The Petition Is Deficient Because It Fails to Name Bard
`Access Systems, Inc. as an RPI ................................................59
`
`V.
`
`
`CONCLUSION ..............................................................................................60
`
`APPENDIX A - LIST OF EXHIBITS
`
`
`
`
`
`iv
`
`

`
`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Page(s)
`
`ActiveVideo Networks, Inc. v. Verizon Commc’n, Inc.,
`694 F.3d 1312 (Fed. Cir. 2012) ..................................................................... 10
`
`Air Liquide Large Industries U.S. LP v. Praxair Technology, Inc.,
`IPR2015-01074, Paper 11 (P.T.A.B. Oct. 26, 2015) ............................... 46, 51
`
`Apple v. Virnetx,
`IPR2014-00237, Paper 24 (P.T.A.B. June 30, 2014) .................................... 38
`
`Atlanta Gas Light Company v. Bennett Regulator Guards, Inc.,
`IPR2013-00453, Paper 88 (P.T.A.B. Jan. 6, 2015) ................................. 55, 59
`
`Bruckelmyer v. Ground Heaters, Inc.,
`445 F.3d 1374 (Fed. Cir. 2006) ..................................................................... 43
`
`Google, Inc. v. ART+COM Innovationpool GMBH,
`IPR2015-00789, Paper 8 (P.T.A.B. Sept. 2, 2015) ................................. 43, 44
`
`International Securities Exchange v. Chicago Board Options Exchange,
`IPR2014-00097, Paper 12 (P.T.A.B. May 22, 2014) .................................... 39
`
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) ......................................................................... 8
`
`Kinetic Technologies, Inc. v. Skyworks Solutions, Inc.,
`IPR2014-00529, Paper 8 (P.T.A.B. Sept. 23, 2014) ..................................... 10
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007)..................................................................................... 7, 8
`
`Kyocera Wireless Corp. v. Int’l Trade Comm’n,
`545 F.3d 1340 (Fed. Cir. 2008) ..................................................................... 43
`
`Lantz Medical, Inc. v. Bonutti Research, Inc.
`IPR2015-00995, Paper 11 (P.T.A.B. Oct. 21, 2015) ..................................... 11
`
`In re Lister,
`583 F.3d 1307 (Fed. Cir. 2009) ......................................................... 49, 52, 53
`
`v
`
`

`
`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
`
`Reflectix, Inc. v. Promethean Insulation Tech. LLC,
`IPR2015-00039, Paper 18 (P.T.A.B. April 24, 2015) ................................... 55
`
`Rohm and Haas Co. v. Brotech Corp.,
`127 F.3d 1089 (Fed. Cir. 1997) ..................................................................... 44
`
`Taylor v. Sturgell,
`533 U.S. 880 (2008)................................................................................. 54, 55
`
`In re Wyer,
`655 F.2d 211 (C.C.P.A. 1981) ....................................................................... 43
`
`Zoll Lifecor Corp. v. Philips Elec. N. Am. Corp.,
`IPR2013-00606, Paper 13 (P.T.A.B. Mar. 20, 2014) .................................... 55
`
`
`
`Statutes
`
`35 U.S.C. § 102 .......................................................................................................... 2
`
`35 U.S.C. § 103(a) ..................................................................................................... 7
`
`35 U.S.C. § 311(b) ................................................................................................... 43
`
`35 U.S.C. § 312(a)(2) ............................................................................................... 59
`
`35 U.S.C. § 313 .......................................................................................................... 1
`
`35 U.S.C. § 316(e) ..................................................................................................... 7
`
`
`
`Rules
`
`37 C.F.R. § 42.1(d) .................................................................................................... 7
`
`37 C.F.R. § 42.65(a) ..........................................................................................passim
`
`37 C.F.R. § 42.100(b) ................................................................................................ 7
`
`37 C.F.R. § 42.104(b)(4) .............................................................................. 38, 41, 43
`
`37 C.F.R. § 42.104(b)(5) .......................................................................................... 47
`
`vi
`
`

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`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
`
`37 C.F.R. § 42.107 ..................................................................................................... 1
`
`Fed. R. Evid. § 602 .................................................................................................. 44
`
`Office Patent Trial Practice Guide,
`77 Fed. Reg. 48756 (Aug. 14, 2012) ................................................. 54, 55, 58
`
`
`
`vii
`
`

`
`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
`
`I.
`
`
`INTRODUCTION
`
`Patent Owner, Medical Components, Inc. (“MedComp” or “Patent Owner”),
`
`submits the instant Preliminary Response to the Petition for Inter Partes Review
`
`(“Petition” or “Pet.”) filed by C.R. Bard, Inc. (“Bard” or “Petitioner”) on July 31,
`
`2015, against U.S. Patent No. 8,257,325 (Ex. 1001, “the ‘325 Patent”). The
`
`Preliminary Response is timely filed under 35 U.S.C. § 313 and 37 C.F.R.
`
`§ 42.107.
`
`The Petition is deficient for several reasons. Petitioner cites six alleged prior
`
`art documents (i.e., PORTS (Ex. 1002), Powers, (Ex. 1003), PowerPort (Ex. 1004),
`
`Meyer (Exs. 1005, 1006), Sayre (Ex. 1007), and Hickman (Ex. 1017)) in support of
`
`three grounds of unpatentability. However, Petitioner has not adequately
`
`explained why it would have been obvious to modify the non-power rated port of
`
`PORTS to be rated for power injection. In addition, Petitioner’s rationale for
`
`modifying the flange of the port of PORTS to have X-ray discernable indicia or
`
`cutouts extending through the height of the flange and configured to indicate,
`
`under X-ray examination, that the assembly is rated for power injection, is based
`
`on a misapprehension of the alleged prior art. In a separate proceeding, Petitioner
`
`itself admitted to reasons why it would not have been obvious to employ
`
`alphanumeric voids or cutouts in a structural component of a port.
`
`1
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`

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`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
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`
`
`Second, the Petition fails to specify where each claim limitation is found in
`
`the applied documents and fails to map the teaching of the alleged prior art to the
`
`construed claims. For instance, the Petition fails to specify where the applied
`
`documents disclose a flange comprising X-ray discernable indicia or X-ray
`
`discernable material, as recited in claim 1, 12, and 17 of the ‘325 Patent. In
`
`addition, the Petition fails to specify where the applied documents disclose a flange
`
`comprised of a metal material, as recited in claim 5 of the ‘325 Patent. Further, the
`
`Petition fails to specify where the applied documents disclose that “the indicia are
`
`located within predetermined suture openings,” as recited in claim 7 of the ‘325
`
`Patent.
`
`Third, Petitioner has not satisfied its burden of demonstrating that PORTS,
`
`PowerPort, and Hickman constitute prior art. The unsupported testimonies of Ms.
`
`Annemarie Boswell (Ex. 1018) and Mr. David P. Blaber (Ex. 1019) fail to
`
`establish that PORTS, PowerPort, and Hickman constitute printed publications
`
`under 35 U.S.C. § 102.
`
`Fourth, the Petition does not name all real parties-in-interest and thus should
`
`be denied. The Petition identifies C. R. Bard, Inc. as the only real party-in-interest.
`
`Evidence submitted by Petitioner, however, demonstrates that Bard Access
`
`Systems, Inc. is an interested party that desires review of the ‘325 Patent and that
`
`2
`
`

`
`Bard Access Systems, Inc. has exercised control, or could have exercised control,
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`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
`
`over this IPR proceeding.
`
` BACKGROUND OF THE ‘325 PATENT II.
`
`
` Background of the ‘325 Patent A.
`
`
`Venous access ports provide for infusion and/or withdrawal of fluids from a
`
`patient. Ex. 1001 at 1:19-20. Such ports are implanted under the skin and provide
`
`an access site for multiple needle sticks through the covering skin tissue of the
`
`patient, without the need to continuously search for new access sites. Ex. 1001 at
`
`1:23-30. Injection of fluid into a venous access port may be conducted manually
`
`or by a power injector system. Ex. 1001 at 1:59-61; Ex. 1003 at 3:42-59. Some
`
`ports are specifically designed to accommodate power injection (i.e., rated for
`
`power injection), whereas other ports are not designed for such application (i.e.,
`
`not rated for power injection). Id. For example, the port depicted in Fig. 52B of
`
`Powers (Ex. 1003) is rated for power injection, whereas Titanium Implanted Port
`
`of PORTS (Ex. 1002 at 10) is not rated for power injection.
`
`Once a port is implanted, it can be difficult to determine whether the
`
`implanted port is rated for power injection. Ex. 1001 at 1:43-45 (“These
`
`characteristics might otherwise be unknown once the port is implanted under the
`
`skin of the patient.”). To address this issue, Bard Access Systems, Inc. utilizes a
`
`3
`
`

`
`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
`
`triangle port housing and palpation points on the septum as means for identifying
`
`its PowerPort devices as a port rated for power injection. Ex. 1004.
`
`B.
`
`
`The ‘325 Patent Provides a Port Assembly Having X-Ray
`Discernable Indicia or Cutouts in the Flange Configured to
`Indicate that the Assembly is Rated for Power Injection
`
`An exemplary venous access port assembly of the ‘325 Patent is depicted
`
`below in Fig. 1 (isometric view) and Fig. 4 (cross-sectional view):
`
`
`Figs. 1 and 4 of the ‘325 Patent (Ex. 1001)
`
`
`
`The venous access port assembly 10 includes a housing 12, a needle-penetrable
`
`septum 14, and a discharge port 16 extending from a distal end 18 of the port
`
`assembly 10 to be attached securely and sealingly to the proximal end of a catheter.
`
`Ex. 1001 at 3:11-15. The housing 12 includes a base 28 defining at least one
`
`reservoir 22, and a flange 36 adjacent to the at least one reservoir 22 and extending
`
`outwardly from the at least one reservoir 22. Ex. 1001 at 3:26-32. The housing
`
`base 28 includes a well 30 having a bottom floor 32 and side walls 34 that define
`
`4
`
`

`
`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
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`the reservoir 22 beneath the septum 14. Id. The flange 36 includes openings that
`
`serve to enable suturing of the port 10 to a patient upon subcutaneous placement of
`
`the port 10 into the patient. Ex. 1001 at 3:33-35.
`
`As shown in Fig. 4, a skirt 42 is overmolded about the base 28 and may be
`
`of silicone elastomer. Ex. 1001 at 3:36-37. The skirt 42 may fill suture holes 38,
`
`40 in the flange 36, but since the material of the skirt 42 can be of silicone
`
`elastomer, suturing is possible since the suturing needle can be inserted through the
`
`material of the skirt 42. Ex. 1001 at 3:36-45.
`
`To provide means for determining whether the port is rated for power
`
`injection after implantation, the venous access port includes voids or cutouts
`
`extending through the X-ray discernable material of the flange 36 from the top
`
`surface of the flange 36 to the bottom surface of the flange 36. Ex. 1001 at 4:44-
`
`57, 2:48-62. The X-ray discernable indicia or cutouts extending through the height
`
`of the flange are configured to indicate, under X-ray examination, that the venous
`
`port assembly 10 is rated for power injection. Ex. 1001 at 1:59-2:4, 2:48-62, 4:44-
`
`57. Exemplary X-ray discernable indicia or cutouts in the flange are depicted
`
`below:
`
`5
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`U.S. Patent No. 8,257,325
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`
`
`
`
`Figs. 11 to 13 of the ‘325 Patent (Ex. 1001)
`
`As seen in Figs. 11-13, the flange of the port assembly 10 includes X-ray
`
`discernible indicia or cutouts (“CT”) configured to indicate, under X-ray
`
`examination, that the port assembly 10 is rated for power injection. Ex. 1001 at
`
`1:59-2:4, 4:44-57, Figs. 11-13.
`
` CLAIM CONSTRUCTION III.
`
`
`In an IPR, “[a] claim in an unexpired patent shall be given its broadest
`
`reasonable construction in light of the specification of the patent in which it
`
`6
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`U.S. Patent No. 8,257,325
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`appears.” 37 C.F.R. § 42.100(b). Patent Owner does not necessarily agree with
`
`any of the proposed claim constructions offered in the Petition and reserves the
`
`right to challenge Petitioner’s asserted claim constructions.
`
` ARGUMENT IV.
`
`
`The Petition fails to establish a reasonable likelihood that claims 1, 2, 5-13,
`
`15-19, and 21-22 of the ‘325 Patent are obvious over the three grounds of
`
`unpatentability set forth in the Petition, i.e., PORTS in view of Powers and in
`
`further view of PowerPort and Hickman (Ground 1, Pet. at 27-49), PORTS in view
`
`of Powers and in further view of Sayre and Hickman (Ground 2, Pet. at 50-53), and
`
`PORTS in view of Powers and in further view of Meyer and Hickman (Ground 3,
`
`Pet. at 54-58). The deficiencies of the Petition are discussed below.
`
`
` The Petition Fails to Provide Adequate Reasoning for Combining A.
`the Alleged Prior Art
`
`To prevail in its challenges to the patentability of the claims, Petitioner must
`
`establish facts supporting its challenges by a preponderance of the evidence. 35
`
`U.S.C. § 316(e); 37 C.F.R. § 42.1(d). In order to establish obviousness of a
`
`claimed invention under 35 U.S.C. § 103(a), Petitioner must establish that the
`
`differences between the subject matter sought to be patented and the prior art are
`
`such that the subject matter as a whole would have been obvious at the time the
`
`invention was made to a person having ordinary skill in the art to which the subject
`
`matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). A patent
`7
`
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`
`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
`
`claim composed of several elements is not proved obvious merely by
`
`demonstrating that each of its elements was known, independently, in the prior art.
`
`See KSR, 550 U.S. at 418. “[R]ejections on obviousness grounds cannot be
`
`sustained by mere conclusory statements; instead, there must be some articulated
`
`reasoning with some rational underpinning to support the legal conclusion of
`
`obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006); see also KSR, 550
`
`U.S. at 418.
`
`The Petition does not provide adequate reasoning based on rational
`
`underpinnings for why one of ordinary skill in the art would have modified the
`
`alleged prior art to arrive at the features of the claims.
`
`1.
`
`It Would Not Have Been Obvious to Modify Titanium
`Implanted Port of PORTS to Be Rated for Power Injection
`
`The Petition does not provide adequate reasoning with rational
`
`underpinnings as to why it would have been obvious to modify Titanium
`
`Implanted Port of PORTS in view of Powers to be rated for power injection.
`
` Mr. Tallarida Provides No Underlying Facts or Data a.
`
`
`to Support His Conclusions
`
`Petitioner admits that “PORTS does not disclose that Titanium Implanted
`
`Port is a power injectable port.” Pet. at 24-25; Id. at 31. Petitioner alleges that it
`
`would have been obvious to modify Titanium Implanted Port of PORTS in view of
`
`8
`
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`
`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
`
`Powers to be rated for power injection. Id. at 29. Petitioner’s rationale is
`
`reproduced below:
`
`A POSA would have known that the Titanium Implanted Port in view
`of Powers could be constructed to handle power injection.
`Specifically, Titanium Implanted Port would be modified in view of
`Powers to handle the higher pressures and flow rates associated with
`power injection for injecting contrast media, e.g., for a CT scan. Ex.
`1009, ¶¶ 147-148.
`
`Id. at 31; Id. at 51, 56. The only evidence cited by Petitioner in support of its
`
`rationale for modifying PORTS to be rated for power injection is the testimony of
`
`its expert witness, Mr. Tallarida, set forth below:
`
`147. A person of ordinary skill in the art at the time of the invention
`would have understood that PORTS, as evidence by Hickman,
`discloses all of the elements of claim 1 other than that the Titanium
`Implanted Port was power injectable and the indicia indicating “that
`the assembly is rated for power injection.”
`
` 148. A person of ordinary skill in the art would have known that the
`Titanium Implanted Port in view of Powers could be constructed to
`handle power injection. Specifically, Titanium Implanted Port would
`be modified in view of Powers to handle the higher pressures and flow
`rates associated with power injection for injecting contrast media, e.g.,
`for a CT scan.
`
`Ex. 1009 at ¶¶ 147-48. Paragraph 147 merely admits deficiencies of PORTS.
`
`Paragraph 148 merely repeats the conclusory statements set forth in the Petition.
`
`Mr. Tallarida does not explain what modifications would be made to Titanium
`
`Implanted Port of PORTS in view of Powers to render Titanium Implanted Port
`
`rated for power injection. Nor does Mr. Tallarida explain how the modifications
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`U.S. Patent No. 8,257,325
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`would have been made. Mr. Tallarida cites to no underlying facts or data to
`
`support his conclusions. “Expert testimony that does not disclose the underlying
`
`facts or data on which the opinion is based is entitled to little or no weight.” 37
`
`C.F.R. § 42.65(a). See also ActiveVideo Networks, Inc. v. Verizon Commc’n, Inc.,
`
`694 F.3d 1312, 1327 (Fed. Cir. 2012); Kinetic Technologies, Inc. v. Skyworks
`
`Solutions, Inc., IPR2014-00529, Paper 8 at 15 (P.T.A.B. Sept. 23, 2014) (“The
`
`Declaration does not explain the ‘how,’ ‘what,’ and ‘why’ of the proposed
`
`combination of references…. Accordingly, we give [the] Declaration no probative
`
`weight.”).
`
`Second, Mr. Tallarida’s testimony merely restates the argument set forth in
`
`the Petition without providing any additional facts or data in support of the
`
`argument. Pet. at 31; Ex. 1009 at ¶¶ 147-48. Such testimony provides no
`
`enhanced probative value. Id. (“Merely repeating an argument from the Petition in
`
`the declaration of a proposed expert does not give that argument enhanced
`
`probative value.”).
`
`In view of the above, Mr. Tallarida’s testimony concerning the alleged
`
`modification of PORTS to be rated for power injection should be given no weight.
`
`“Providing broad notice of Petitioner’s allegations with virtually no
`
`supporting evidence or explanation is generally not sufficient to institute trial in an
`
`inter partes review proceedings as it leaves both the Board and Patent Owner in
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`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
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`the untenable position of either evaluating or responding to incompletely formed
`
`arguments and arguably ambiguous assertions.” Lantz Medical, Inc. v. Bonutti
`
`Research, Inc. IPR2015-00995, Paper 11 at 7 (P.T.A.B. Oct. 21, 2015) (emphasis
`
`added). The Petition in this proceeding is similarly deficient.
`
`b.
`
`
`PowerPort Provides Evidence that It Would Not Have
`Been Obvious to Modify Titanium Implanted Port to
`Be Rated for Power Injection
`
`Petitioner’s own evidence, PowerPort, provides guidelines for operating
`
`Bard’s “PowerPort” devices. Ex. 1004. PowerPort discloses that a technologist
`
`can determine whether an implanted port is a “PowerPort” device (i.e., a port rated
`
`for power injection) by “Palpat[ing] the sides of the port to identify triangular port
`
`housing.” Ex. 1004 (emphasis in original). Such “triangle shape feel” test for
`
`discerning the triangular housing of the “PowerPort” device is depicted below:
`
`
`
`“Triangle Shape Feel” Test of
`Triangular Housing of the
`PowerPort (Ex. 1004)
`“PowerPort” Device (Ex. 1004)
`Further, PowerPort discloses that the “PowerPort” device (i.e., the port rated for
`
`power injection) has a triangular housing, whereas a comparative port having a
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`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
`circular housing is not a “PowerPort” device, and thus is not rated for power
`
`injection:
`
`
`Circular Housing Indicating that the
`Port Is Not Rated for Power Injection
`(Ex. 1004)
`
`
`Triangular Housing Indicating that
`the Port Is Rated for Power Injection
`(Ex. 1004)
`
`Petitioner alleges that it would have been obvious to modify Titanium
`
`Implanted Port of PORTS in view of Powers to be rated for power injection. Pet.
`
`at 29. However, Titanium Implanted Port of PORTS has a circular housing, not a
`
`triangular housing. Ex. 1002 at 10. The circular housing of Titanium Implanted
`
`Port of PORTS and the triangular housing of PowerPort are shown below:
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`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
`
`
`Triangular Housing of PowerPort
`(Ex. 1004)
`
`
`Circular Housing of Titanium
`Implanted Port of PORTS
`(Ex. 1002 at 10)
`
`
`Due to its circular shape, the modified port would fail PowerPort’s “triangle shape
`
`feel” test and cause confusion as to whether the modified port is in fact rated for
`
`power injection. Petitioner’s own evidence, PowerPort, demonstrates that it
`
`would not have been obvious to modify Titanium Implanted Port to be power
`
`rated.
`
`For the above reasons, the Petition fails to provide reasoning with rational
`
`underpinnings that it would have been obvious to modify Titanium Implanted Port
`
`of PORTS in view of Powers to be rated for power injection. Absent such
`
`modification, it also would not have been obvious to modify Titanium Implanted
`
`Port to have X-ray discernable indicia or cutouts configured to indicate, under X-
`
`ray examination, that the port assembly is rated for power injection, as recited in
`
`independent claims 1, 12, and 17. Ex. 1001 at 5:19-24, 5:66-6:5, 6:37-43. This is
`
`because a person of ordinary skill in the art would not have modified a port not
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`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
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`rated for power injection (i.e., Titanium Implanted Port) to include indicia or
`
`cutouts indicating that such port is rated for power injection.
`
`2.
`
`It Would Not Have Been Obvious to Modify the Flange of
`PORTS to Have X-ray Discernable Indicia or Cutouts
`Configured to Indicate that the Assembly is Rated for
`Power Injection
`
`According to independent claims 1 and 17, the flange comprises “X-ray
`
`discernable indicia configured to indicate, under X-ray examination, that the port
`
`assembly is rated for power injection.” Ex. 1001 at 5:19-21, 6:40-43. Independent
`
`claims 1 and 17 further recite that the X-ray discernable indicia is located or
`
`formed in the flange and “extend[s] through the height of the flange from the top
`
`surface of the flange to the bottom surface of the flange.” Ex. 1001 at 5:21:24,
`
`6:37-40.
`
`According to independent claim 12, the flange comprises “one or more
`
`cutouts configured to indicate, under X-ray examination, that the port assembly is
`
`rated for power injection.” Ex. 1001 at 6:3-5. Independent claim 12 further recites
`
`that the “cutouts extend[] entirely through the height of the flange from the top
`
`surface of the flange to the bottom surface of the flange.” Ex. 1001 at 5:66-6:3.
`
`Thus, claims 1, 12, and 17 require the flange to have X-ray discernable indicia or
`
`cutouts extending through the height of the flange and configured to indicate,
`
`under X-ray examination, that the assembly is rated for power injection.
`
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`
`Exemplary ports having such structure in the flange are depicted in Figs. 11-13 of
`
`the ‘325 patent, reproduced below:
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`Case No. IPR2015-01660
`U.S. Patent No. 8,257,325
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`
`
`
`
`Figs. 11 to 13 of the ‘325 Patent (Ex. 1001)
`
`Petitioner admits that PORTS fails to disclose voids or indicia configured to
`
`indicate that the assembly is rated for power injection. Pet. at 24-25, 31. As
`
`discussed below, Petitioner’s attempt to cure such deficiencies of PORTS is based
`
`on a misapprehension of the teachings of the alleged prior art.
`
`a.
`
`
`The Orientation Holes of PORTS Are for Securing
`the Orientation of the Port, Not for Providing Indicia
`of Orientation under X-ray Examination
`
`Petitioner alleges that it would have been obvious to modify Titanium
`
`Implanted Port of PORTS “to include X-ray discernable indicia comprising
`
`alphanumeric characters in the form of voids extending through the height of the
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`flange.” Pet. at 33. In support of this allegation, Petitioner alleges that “Titanium
`
`Implanted Port includes holes (voids) in the flange which, under X-