UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`C.R. BARD, INC.
`Petitioner
`
`v.
`
`INNOVATIVE MEDICAL DEVICES, LLC,
`MEDICAL COMPONENTS, INC.
`Patent Owners
`____________
`
`Case IPR _____________
`U.S. Patent No. 8,257,325
`Issue Date: September 4, 2012
`
`Title: VENOUS ACCESS PORT WITH MOLDED
`AND/OR RADIOPAQUE INDICIA
`
`____________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 8,257,325 UNDER
`35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 ET SEQ.
`
`
`
`
`
`Mail Stop PATENT BOARD, PTAB
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`

`
`TABLE OF CONTENTS
`
`I.
`
`MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1) ......................... 1
`
`A.
`
`Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) ........................... 1
`
`B.
`
`C.
`
`Related Matters Under 37 C.F.R. § 42.8(b)(2) .................................... 1
`
`Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3) ................. 1
`
`D.
`
`Service Information Under 37 C.F.R. § 42.8(b)(4) .............................. 1
`
`II.
`
`PAYMENT OF FEES ................................................................................... 2
`
`III. REQUIREMENTS FOR INTER PARTES REVIEW - 37 C.F.R. § 42.104 .... 2
`
`A. Grounds For Standing Under 37 C.F.R. § 42.104(a) ........................... 2
`
`B.
`
`Identification Of Challenge Under 37 C.F.R. § 42.104(b) ................... 2
`
`1. Claims For Which Inter Partes Review Is Requested Under 37
`C.F.R. § 42.104(b)(1) .................................................................... 2
`
`2. The Specific Art And Statutory Ground(s) On Which The
`Challenge Is Based Under 37 C.F.R. § 42.104(b)(2) ..................... 2
`
`3. How The Challenged Claims Are To Be Construed Under 37
`C.F.R. § 42.104(b)(3) .................................................................... 4
`
`4. How The Construed Claims Are Unpatentable Under
`37 C.F.R. § 42.104(b)(4) ............................................................... 6
`
`5. Supporting Evidence Under 37 C.F.R. § 42.104(b)(5) .................. 6
`
`6. One Of Ordinary Skill In The Art At The Time Of Invention ....... 7
`
`IV. SUMMARY OF THE ‘325 PATENT ........................................................... 8
`
`A. Description Of The Alleged Invention Of The ‘325 Patent ................. 8
`
`B.
`
`Summary Of The Prosecution Of The ‘325 Patent ............................ 10
`
`V.
`
`STATEMENT OF MATERIAL FACTS UNDER 37 C.F.R. § 42.22(c) ..... 11
`
`
`
`i
`
`

`
`VI. THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST
`ONE CLAIM OF THE ‘325 PATENT IS UNPATENTABLE.................... 18
`
`A.
`
`Identification Of The References As Prior Art .................................. 18
`
`B.
`
`Summary Of Invalidity Arguments ................................................... 24
`
`VII. DETAILED EXPLANATION UNDER 37 C.F.R. § 42.104(b) .................. 27
`
`A. Ground 1: Claims 1-2, 5-13, 15-19 And 21-22 Are Unpatentable
`As Obvious Under 35 U.S.C. §103(a) Over PORTS In View Of
`Powers And In Further View Of PowerPort And Hickman. .............. 27
`
`1. Independent Claim 1 Is Unpatentable As Obvious .......................27
`
`2. Dependent Claim 2 Is Unpatentable As Obvious .........................34
`
`3. Dependent Claim 5 Is Unpatentable As Obvious .........................35
`
`4. Dependent Claim 6 Is Unpatentable As Obvious .........................35
`
`5. Dependent Claim 7 Is Unpatentable As Obvious .........................36
`
`6. Dependent Claim 8 Is Unpatentable As Obvious .........................37
`
`7. Dependent Claim 9 Is Unpatentable As Obvious .........................37
`
`8. Dependent Claim 10 Is Unpatentable As Obvious .......................38
`
`9. Dependent Claim 11 Is Unpatentable As Obvious .......................38
`
`10. Independent Claim 12 Is Unpatentable As Obvious .....................39
`
`11. Dependent Claim 13 Is Unpatentable As Obvious .......................43
`
`12. Dependent Claim 15 Is Unpatentable As Obvious .......................44
`
`13. Dependent Claim 16 Is Unpatentable As Obvious .......................45
`
`14. Independent Claim 17 Is Unpatentable As Obvious .....................45
`
`15. Dependent Claim 18 Is Unpatentable As Obvious .......................46
`
`16. Dependent Claim 19 Is Unpatentable As Obvious .......................48
`
`
`
`ii
`
`

`
`17. Dependent Claim 21 Is Unpatentable As Obvious .......................48
`
`18. Dependent Claim 22 Is Unpatentable As Obvious .......................49
`
`B.
`
`Ground 2: Claims 1-2, 5-13, 15-19 And 21-22 Are Unpatentable
`As Obvious Under 35 U.S.C. §103(a) Over PORTS In View Of
`Powers And In Further View Of Sayre And Hickman. ...................... 50
`
`1. Independent Claim 1 Is Unpatentable As Obvious .......................50
`
`2. Independent Claims 12 And 17 Are Unpatentable As Obvious ....53
`
`3. Dependent Claims 2, 5-11, 13, 15, 16, 18, 19 And 21-22 Are
`Also Unpatentable As Obvious ....................................................53
`
`C.
`
`Ground 3: Claims 1-2, 5-13, 15-19 And 21-22 Are Unpatentable
`As Obvious Under 35 U.S.C. §103(a) Over PORTS In View Of
`Powers And In Further View Of Meyer And Hickman. .................... 54
`
`1. Independent Claim 1 Is Unpatentable As Obvious .......................55
`
`2. Independent Claims 12 And 17 Are Unpatentable As Obvious ....58
`
`3. Dependent Claims 2, 5-11, 13, 15, 16, 18, 19 And 21-22 Are
`Also Unpatentable As Obvious ....................................................58
`
`VIII. CONCLUSION .......................................................................................... 59
`
`
`
`
`
`iii
`
`

`
`TABLE OF AUTHORITIES
`
`Statutes
`
`35 U.S.C. § 102(a) ............................................................................................ 3, 20
`
`35 U.S.C. § 102(b) ............................................................................ 3, 4, 18, 22, 23
`
`35 U.S.C. §§ 311-319 ............................................................................................ 1
`
`35 U.S.C. §102(e) .................................................................................................20
`
`35 U.S.C. §103(a) ................................................................................. 3, 27, 50, 54
`
`Regulations
`
`37 C.F.R. § 42.10(b) .............................................................................................. 1
`
`37 C.F.R. § 42.100 ................................................................................................. 1
`
`37 C.F.R. § 42.100(b) ............................................................................................ 4
`
`37 C.F.R. § 42.104 ................................................................................................. 2
`
`37 C.F.R. § 42.104(a)............................................................................................. 2
`
`37 C.F.R. § 42.104(b) ....................................................................................... 2, 27
`
`37 C.F.R. § 42.104(b)(1) ........................................................................................ 2
`
`37 C.F.R. § 42.104(b)(2) ........................................................................................ 2
`
`37 C.F.R. § 42.104(b)(3) ........................................................................................ 4
`
`37 C.F.R. § 42.104(b)(4) ........................................................................................ 6
`
`37 C.F.R. § 42.104(b)(5) ........................................................................................ 6
`
`37 C.F.R. § 42.108(c)............................................................................................60
`
`37 C.F.R. § 42.15(a)(1-4) ....................................................................................... 2
`
`37 C.F.R. § 42.22(c) .............................................................................................11
`
`37 C.F.R. § 42.63(a) .............................................................................................. 7
`
`
`
`iv
`
`

`
`37 C.F.R. § 42.8(a)(1) ............................................................................................ 1
`37CER§4Z&mU) .......................................................................................... "1
`
`37 C.F.R. § 42.8(b)(1) ............................................................................................ 1
`37cER§4z&mu) .......................................................................................... "1
`
`37 C.F.R. § 42.8(b)(2) ............................................................................................ 1
`37CER§4Z&mQ) .......................................................................................... .4
`
`37 C.F.R. § 42.8(b)(3) ............................................................................................ 1
`37CER§4Z&mG) .......................................................................................... "1
`
`37 C.F.R. § 42.8(b)(4) ............................................................................................ 1
`37CER§4Z&mM) .......................................................................................... .4
`
`
`
`
`
`v
`
`

`
`Exhibit 1001:
`
`U.S. Patent No. 8,852,160 B2
`
`EXHIBIT LIST
`
`Exhibit 1002:
`
`PORTS – Bard Access Systems, 2003 (“PORTS”)
`
`Exhibit 1003:
`
`U.S. Patent No. 7,785,302 (“Powers”)
`
`Exhibit 1004:
`
`PowerPort Guidelines for CT Technologists, February 2007
`(“PowerPort”)
`
`Exhibit 1005:
`
`FR 1,509,165 (“Meyer”)
`
`Exhibit 1006:
`
`English translation of Meyer with certification
`
`Exhibit 1007:
`
`U.S. Patent No. 6,826,257 (“Sayre”)
`
`Exhibit 1008:
`
`Affidavit of Christopher Butler
`
`Exhibit 1009:
`
`Declaration of Steven J. Tallarida
`
`Exhibit 1010:
`
`Dictionary definition of housing downloaded June 23, 2015
`from www.merriam-webster.com/dictionary/housing
`
`Exhibit 1011:
`
`Dictionary definition of base downloaded June 23, 2015 from
`www.merriam-webster.com/dictionary/base
`
`Exhibit 1012:
`
`Dictionary definition of reservoir downloaded June 23, 2015
`from www.merriam-webster.com/dictionary/reservoir
`
`Exhibit 1013:
`
`Dictionary definition of flange downloaded June 23, 2015 from
`www.merriam-webster.com/dictionary/flange
`
`Exhibit 1014:
`
`Dictionary definition of adjacent downloaded June 23, 2015
`from www.merriam-webster.com/dictionary/adjacent
`
`Exhibit 1015:
`
`Dictionary definition of void downloaded June 23, 2015 from
`www.merriam-webster.com/dictionary/void
`
`Exhibit 1016:
`
`U.S. Provisional Application No. 60/658,518, filed on March 4,
`2005.
`
`
`
`vi
`
`

`
`Exhibit 1017:
`
`Hickman® Subcutaneous Ports & Hickman®/Broviac®
`Catheters, 1992.
`
`Exhibit 1018:
`
`Declaration of Annemarie Boswell
`
`Exhibit 1019:
`
`Declaration of David P. Blaber
`
`vii
`
`
`
`
`
`

`
`On behalf of C.R. Bard, Inc. (“Bard” or “Petitioner”) and in accordance with
`
`35 U.S.C. §§ 311-319 and 37 C.F.R. § 42.100 et seq., inter partes review is
`
`respectfully requested for claims 1-2, 5-13, 15-19 and 21-22 of U.S. Patent No.
`
`8,257,325 B2 (“the ‘325 patent”).
`
`I. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1)
`
`A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1)
`
`Bard is the real party-in-interest for the instant Petition.
`
`B. Related Matters Under 37 C.F.R. § 42.8(b)(2)
`
`At present, there are no related matters relating to the ‘325 patent or its
`
`continuation, U.S. Patent No. 8,852,160; however, filed concurrently herewith is a
`
`Petition For Inter Partes Review Of U.S. Patent No. 8,852,160.
`
`C. Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`
`Petitioner’s designation of counsel: Lead counsel is Michael J. Fink (Reg.
`
`No. 31,827) and back-up counsel is Arnold Turk (Reg. No. 33,094). Per 37 C.F.R.
`
`§ 42.10(b), a Power of Attorney accompanies this Petition.
`
`D. Service Information Under 37 C.F.R. § 42.8(b)(4)
`
`Papers concerning this matter should be served on the following:
`
`
`
`
`Michael J. Fink
`Greenblum & Bernstein, P.L.C.
`1950 Roland Clarke Place
`
`Reston, VA 20191
`
`
`Tel: (703) 716-1191
`
`
`Fax: (703) 716-1180
`
`
`
`Arnold Turk
`Greenblum & Bernstein, P.L.C.
`1950 Roland Clarke Place
`Reston, VA 20191
`Tel: (703) 716-1191
`Fax: (703) 716-1180
`
`
`
`1
`
`

`
`Email: MFink@gbpatent.com
`
`
`
`Email: ATurk@gbpatent.com
`
`
`
`II.
`
`Petitioner consents to electronic service by email.
`
`PAYMENT OF FEES
`
`Payment of $24,200 for the fees set forth in 37 C.F.R. § 42.15(a)(1-4) for
`
`this Petition for Inter Partes Review accompanies this request by way of credit
`
`card payment. The undersigned authorizes payment for any additional fees due in
`
`connection with this Petition to be charged to Deposit Account No. 19-0089.
`
`III. REQUIREMENTS FOR INTER PARTES REVIEW - 37 C.F.R. § 42.104
`
`A. Grounds For Standing Under 37 C.F.R. § 42.104(a)
`
`Petitioner hereby certifies that the ‘325 patent is available for inter partes
`
`review and that the Petitioner is not barred or estopped from requesting inter partes
`
`review challenging the claims of the ‘325 patent.
`
`B. Identification Of Challenge Under 37 C.F.R. § 42.104(b)
`
`1. Claims For Which Inter Partes Review Is Requested Under 37 C.F.R.
`§ 42.104(b)(1)
`
`Petitioner requests inter partes review of claims 1-2, 5-13, 15-19 and 21-22
`
`of the ‘325 patent (“the challenged claims”).
`
`2. The Specific Art And Statutory Ground(s) On Which The Challenge
`Is Based Under 37 C.F.R. § 42.104(b)(2)
`
`Inter partes review of the ‘325 patent (Ex. 1001) is requested in view of the
`
`following prior art references: (1) PORTS – Bard Access Systems, 2003 (a
`
`
`
`2
`
`

`
`Titanium Implanted Port is disclosed at pages 10 and 16)(“PORTS”)(Ex.1002); (2)
`
`U.S. Patent No. 7,785,302 (“Powers”)(Ex.1003); (3) PowerPort Guidelines for CT
`
`Technologists, February 2007 (“PowerPort”)(Ex.1004); (4) FR 1,509,165
`
`(“Meyer”)(Exs.1005 & 1006); (5) U.S. Patent No. 6,826,257 (“Sayre”)(Ex.1007);
`
`and (6) The Hickman® Subcutaneous Ports & Hickman®/Broviac® Catheters, 1992
`
`(“Hickman”)(Ex.1017). The challenged claims are unpatentable as obvious under
`
`35 U.S.C. §103(a), and should be cancelled for at least the following reasons:
`
`Ground 1: Claims 1-2, 5-13, 15-19 and 21-22 are unpatentable as obvious
`
`under 35 U.S.C. §103(a) over PORTS in view of Powers and in further view of
`
`PowerPort and Hickman.
`
`Ground 2: Claims 1-2, 5-13, 15-19 and 21-22 are unpatentable as obvious
`
`under 35 U.S.C. §103(a) over PORTS in view of Powers and in further view of
`
`Sayre and Hickman.
`
`Ground 3: Claims 1-2, 5-13, 15-19 and 21-22 are unpatentable as obvious
`
`under 35 U.S.C. §103(a) over PORTS in view of Powers and in further view of
`
`Meyer and Hickman.
`
`The above grounds are not duplicative. PowerPort is a prior art reference
`
`under pre-AIA 35 U.S.C. § 102(a). Sayre is also a prior art reference under pre-
`
`AIA 35 U.S.C. § 102(b) and provides a general teaching of X-ray discernable
`
`indicia defined by apertures (voids) in radiopaque material. Meyer is a prior art
`
`
`
`3
`
`

`
`reference under pre-AIA 35 U.S.C. § 102(b) and provides a general teaching of
`
`using a flange with identification indicia created by cutouts (voids). PORTS in
`
`view of Powers teaches the elements of the challenged claims, including indicia in
`
`the form of cutouts (voids) on a flange and X-ray viewable indicia in the form of
`
`alphanumeric characters as a power port identifier, rendering the challenged claims
`
`of the ‘325 patent obvious. The tertiary references emphasize the obviousness of
`
`cutouts (voids) in the form of alphanumeric characters, which is taught by
`
`PowerPort (alphanumeric characters cutout in X-ray discernable material), Sayre
`
`(alphanumeric characters cutout in X-ray discernable material), and Meyer
`
`(alphanumeric characters cutout in a flange). Hickman confirms that the Titanium
`
`Implanted Port disclosed in PORTS has a base defining a reservoir, i.e., a bottom
`
`floor and side walls defining a reservoir.
`
`3. How The Challenged Claims Are To Be Construed Under 37 C.F.R.
`§ 42.104(b)(3)
`
`A claim subject to inter partes review receives the “broadest reasonable
`
`construction in light of the specification of the patent in which it appears.” 37
`
`C.F.R. § 42.100(b). Petitioner asserts the following constructions:
`
`Housing: Fig. 1 depicts “housing 12.” Ex. 1001, 3:11-12, 26-29. The term
`
`“housing” as recited in the claims should be construed as a case or enclosure.
`
`Ex.1010.
`
`
`
`4
`
`

`
`Base: Figs. 3-7 depict “housing base 28.” Ex. 1001, 3:24-26. “[H]ousing
`
`base 28 … includes a well 30 having a bottom floor 32 and side walls 34 that
`
`define the interior reservoir 22 beneath septum 14. … Housing base 28 includes a
`
`base flange 36 extending radially outwardly from the bottom of well 30, and base
`
`flange 36 includes openings 38, 40.” Ex. 1001, 3:26-33. Thus, as used in the ‘325
`
`patent, the term “base” as recited in the claims should be construed as the part on
`
`which something rests or is supported. Ex.1011.
`
`Reservoir: Figs. 3 and 4 depict reservoir 22. Ex. 1001, 3:24-29. The
`
`reservoir 22 is defined as “a well 30 having a bottom floor 32 and side walls 34.”
`
`Ex. 1001, 3:27-28. Thus, the term “reservoir” as recited in the claims should be
`
`construed as a part of an apparatus in which a liquid can be held. Ex.1012.
`
`Flange: A “base flange 36” is shown in Figs. 4 and 10 that includes
`
`openings 38, 40 that serve to enable suturing to the patient. Ex. 1001, 3:31-35, 63-
`
`64. The term “flange” as recited in the claims should be construed as a rim
`
`extending outwardly from the base for attachment of the port to a patient. Ex.1013.
`
`Adjacent: The term “adjacent” appears once in the specification (not
`
`including the claims) to describe the position of discharge port 16 to recess 56. Ex.
`
`1001, 3:64. The term “adjacent” as recited in the claims should be construed as
`
`close or near, sharing a border, wall, or point. Ex.1014
`
`
`
`5
`
`

`
`X-ray discernable material: As recited in the claims, “X-ray discernable
`
`material” should be construed as a material that is visible using X-rays. Ex. 1001,
`
`2:13-20.
`
`Void and Cutout: The ‘325 patent discloses “suture openings 38 and holes
`
`40 through base flange 36.” Ex. 1001, 3:63-64, Figs. 10, 11, 12. The ‘325 patent
`
`additionally discloses integrally molded markings within or alongside the suture
`
`openings, “where the markings are voids in the base flange 36 material, as if cut or
`
`punched out of the base flange 36 material.” Ex.1001, 2:60-62; 4:44-60. Thus, the
`
`terms “void” and “cutout’ as recited in the claims of the ‘325 patent should be
`
`construed as an empty space. Ex.1015. The “void” and “cutout” can be made in
`
`any manner as long as it constitutes an empty space that extends through the height
`
`of the flange. Ex.1001, 4:49-57.
`
`All claim terms, including the above terms, should be afforded their ordinary
`
`and customary meanings. Ex.1009, ¶¶ 37-46.
`
`4. How The Construed Claims Are Unpatentable Under 37 C.F.R. §
`42.104(b)(4)
`
`Explanations of how claims 1-2, 5-13, 15-19 and 21-22 are unpatentable
`
`under the grounds identified in Section III.B.2 are provided in Section VI and VII.
`
`5. Supporting Evidence Under 37 C.F.R. § 42.104(b)(5)
`
`The exhibit numbers of the evidence relied upon to support the challenge
`
`and the relevance of the evidence, including identification of specific portions of
`
`
`
`6
`
`

`
`the evidence that support the challenge, are provided in Sections VI and VII. The
`
`Exhibit List is set forth on pages vi-vii. Pursuant to 37 C.F.R. § 42.63(a), this
`
`Petition is supported by the expert declaration of Steven J. Tallarida (“Tallarida
`
`Dec.”) (Ex.1009), attesting to, among other issues, the invalidity of the challenged
`
`claims and supporting bases for the proposed grounds of unpatentability.
`
`6. One Of Ordinary Skill In The Art At The Time Of Invention
`
`A person of ordinary skill in the relevant art (“POSA”) would have been
`
`aware of the structures of venous access port assemblies, including those access
`
`ports comprising a housing with a base, a reservoir, a discharge port extending
`
`from the reservoir and a septum. A POSA would also have been aware of power
`
`injectable access ports and would have known that power injectable access ports
`
`could be used with CT scanning processes, where it is desirable to power inject
`
`contrast media at a higher pressure and using a greater flow rate than can be
`
`handled by conventional access ports. A POSA would also have known of the
`
`desirability to be able to identify an access port as power injectable using X-rays
`
`subsequent to subcutaneous implantation of the port, such as by alphanumeric
`
`characters on the port, such as below the reservoir or on a portion of the port
`
`spaced from a side wall of the reservoir. Moreover, a POSA would also have
`
`known of the desirability of overmolding ports with radiotransparent silicone
`
`
`
`7
`
`

`
`material to reduce ingrowth of tissue into the port to assist removal of the port as
`
`well as to reduce tissue growth into suture/orientation openings.
`
`A POSA in the subject matter claimed and disclosed in the ‘325 patent at the
`
`time of the invention would have included doctors, nurses, radiologists,
`
`practitioners, and technicians who were involved with the implantation, use,
`
`maintenance and/or removal of venous access ports, or other persons who had at
`
`least a bachelor’s degree in mechanical and/or biomedical engineering and
`
`approximately 3-5 years’ experience working with and/or designing venous access
`
`ports, and would have had experience with power injectable access ports.
`
`Ex.1009, ¶¶18-25.
`
`IV. SUMMARY OF THE ‘325 PATENT
`
`A. Description Of The Alleged Invention Of The ‘325 Patent
`
`The ‘325 patent is entitled “Venous Access Port With Molded And/Or
`
`Radiopaque Indicia.” One of the embodiments disclosed in the ‘325 patent is a
`
`venous access port assembly having a housing base with a discharge port, a septum
`
`and a cap. An interior reservoir is defined by a well in the housing base and a
`
`bottom of the septum, and a passageway extends from the reservoir through the
`
`discharge port. The housing base includes a base flange having integrally molded
`
`therein indicia identifying an attribute of the assembly. The indicia could be
`
`formed of base flange material, or could be formed by voids in the base flange
`
`
`
`8
`
`

`
`material. Ex.1001, Abstract p. 1; Ex.1009, ¶¶ 26-31. The general structures of the
`
`ports are depicted in Figs. 1-4 of the ‘325 patent, reproduced below:
`
`
`
`Figures 3 and 4 (reproduced above) show a “skirt 42 is overmolded about
`
`housing base 28 and may be of silicone elastomer. It is seen that skirt 42
`
`encapsulates the outer surfaces of the bottom wall 44 and the bottom portion of the
`
`side walls 46 of housing base 28, and is shown to fill in the suture holes 38,40.”
`
`Ex. 1001, col. 3, lines 36-40, Figs. 3, 4; Ex.1009, ¶¶ 32-33.
`
`Figure 5 (reproduced below) is an isometric view of the base of the access
`
`port of Fig. 1. Ex. 1001, 2:36-37. Ex. 1009, ¶ 34.
`
`
`
`Fig. 11
`
`
`
`
`
`9
`
`

`
`Fig. 11 (reproduced above) shows top views of two alternative embodiments
`
`of the housing base showing integrally molded “CT” markings. Ex. 1001, 2:48-51;
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`Ex.1009, ¶ 36.
`
`B. Summary Of The Prosecution Of The ‘325 Patent
`
`The application for the ‘325 patent, Application No. 12/143,377, was filed
`
`on June 20, 2008. The ‘325 patent claims the benefit of U.S. Provisional
`
`Application No. 60/936,491, filed June 20, 2007. Therefore, depending upon the
`
`claimed subject matter, the earliest possible effective date of the ‘325 patent is
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`June 20, 2007.
`
`All claims presented were repeatedly rejected for anticipation or
`
`obviousness. To obtain allowance of the claims, Applicant amended the
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`independent claims to require that “the port assembly is rated for power injection”
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`and the X-ray discernible indicia is visually “discernable to a naked eye from both
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`the top surface of the flange and the bottom surface of the flange prior to
`
`implantation of the port assembly.” Response and Amendment dated July 6, 2010.
`
`The examiner’s statement of reasons for allowance was as follows:
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`The subject matter of the independent claims 1, 14 and 19 could not
`
`be found or was not suggested in the prior art of record. The subject
`
`matter which was not found is an implantable venous access port
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`assembly comprising a flange with a height extending from a top
`
`surface of the flange to a bottom surface of the flange, the flange
`
`
`
`10
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`

`
`further comprising X-ray discernible indicia extending through the
`
`height of the flange from the top surface of the flange to the bottom
`
`surface of the flange wherein the indicia is visually discernible to the
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`naked eye from the top and bottom surfaces prior to implantation of
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`the port assembly.
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`Notice Of Allowability, July 5, 2012, p.2.
`
`V.
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`STATEMENT OF MATERIAL FACTS UNDER 37 C.F.R. § 42.22(c)
`
`Petitioner provides the following statement of material facts:
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`1. PORTS, which discloses the Titanium Implanted Port, has a copyright date
`
`of 2003. Ex. 1002; Ex. 1019 ¶¶8-10.
`
`2. PORTS is a printed publication which was publicly available no later than
`
`2003. Ex. 1002; Ex. 1019 ¶¶8-18.
`
`3. Titanium Implanted Port, disclosed at pages 10 and 16 of PORTS, is a
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`venous access port, comprising a housing, a base, a discharge port, a septum and
`
`reservoir. Ex. 1002, p. 10, see also Ex.1017.
`
`4. The base of the Titanium Implanted Port defines a reservoir and a bottom
`
`wall of a reservoir, and has a discharge port extending from the reservoir. The
`
`reservoir is located below the septum, and the septum comprises a needle-
`
`penetrable septum communicating with the reservoir. Ex. 1002, see also Ex.1017.
`
`5. The base of the Titanium Implanted Port, including the flange, comprises
`
`titanium. Ex. 1002.
`
`
`
`11
`
`

`
`6. Titanium is an X-ray discernable material.
`
`7. The flange of the Titanium Implanted Port has suture slots and orientation
`
`holes extending from the top surface of the flange to the bottom surface of the
`
`flange. The suture slots and orientation holes are X-ray discernible. Ex. 1002.
`
`8. The flange of the Titanium Implanted Port is adjacent to the reservoir, and
`
`extends radially from the housing base and outwardly from the base about a
`
`perimeter of the reservoir. Ex. 1002.
`
`9. The housing of the Titanium Implanted Port has a biocompatible silicone
`
`skirt overmolded about the flange. The silicone skirt is radiotransparent. Ex.1002.
`
`10. The housing base of the Titanium Implanted Port is substantially the same
`
`as the housing base depicted in Fig. 5 of the ‘325 patent. Both have suture slots
`
`and orientation holes in the flange. Exs.1001, 1002.
`
`11. The suture slots and orientation holes in the flange of the housing base of
`
`the Titanium Implanted Port provide indicia discernable by X-ray concerning the
`
`access port. Ex. 1002.
`
`12. The suture slots and orientation holes in the flange of the housing base of
`
`the Titanium Implanted Port are capable of receiving sutures there through. Ex.
`
`1002.
`
`13. The suture slots and orientation holes in the flange of the housing base of
`
`the Titanium Implanted Port are visually discernable to a naked eye from both the
`
`
`
`12
`
`

`
`top surface of the flange and the bottom surface of the flange prior to implantation
`
`of the port assembly. Ex. 1002.
`
`14. “Hickman ports” are of the same overall structure as Titanium Implanted
`
`Port, including the titanium flange having orientation openings and suture slots, a
`
`base defining a reservoir and a bottom wall of a reservoir, and a silicone overskirt.
`
`Titanium Implanted Port is one commercial form of “Hickman port.”
`
`15. Hickman ports have been publicly available since as early as 1991.
`
`16. Powers was filed on March 6, 2006. Ex. 1003.
`
`17. Powers claims benefit to Provisional Application No. 60/658,518 (“the
`
`‘518 provisional”), filed on March 4, 2005. Ex.1003, cover page and 1:7-9.
`
`18. Powers’ effective date as a prior art reference with respect to the claims
`
`of the ‘325 patent is March 4, 2005, which is the filing date of the ’518 provisional.
`
`19. Powers discloses power injectable ports. Ex.1003, 3:42-59; Ex.1016,
`
`p.7/65 (¶[0034]),p. 48/65 (Nos. 5-7).
`
`20. A power injectable port is adapted to withstand the higher pressures and
`
`flow rates used for injection of contrast fluid. Ex. 1003, 3:42-59; Ex.1016, p.7/65
`
`(¶[0034]).
`
`21. Powers discloses power injectable ports with X-ray discernable indicia
`
`configured to indicate, under X-ray examination, that the assembly is rated for
`
`
`
`13
`
`

`
`power injection. Ex.1003, 3:43-47, 11:41-12:2; Ex.1016, p.7/65 (¶[0034]), p.8/65
`
`(¶[0037]), p.17/65 (¶[0070]), p.48/65 (Nos. 5-7).
`
`22. Powers discloses power injectable ports with radiopaque alphanumeric
`
`characters that convey to a practitioner that the venous access port assembly is
`
`power injectable when an X-ray is taken after implantation. Ex.1003, 3:43-47,
`
`11:41-12:2; Ex.1016, p.7/65 (¶[0034]), p.8/65 (¶[0037]), p.17/65 (¶¶[0069]-
`
`[0070]), p.48/65 (Nos. 5-7).
`
`23. Powers discloses a venous access port 10 with cap 14, base 16, septum 18
`
`and reservoir (cavity) 36. Ex.1003, 4:31-49, Fig. 1B; Ex.1016, p.8/65 (¶[0038]),
`
`Fig. 1B. The base 16 forms a reservoir 36 having a bottom floor and side walls
`
`beneath septum 18. Ex.1003; Ex.1016, Fig. 1B.
`
`24. Powers discloses a needle-penetrable septum in communication with the
`
`housing and a discharge port extending from the reservoir. Ex.1003, 4:29-45, Figs.
`
`1A, 1B; Ex.1016, p.8/65 (¶[0038]), Figs. 1A, 1B.
`
`25. Powers discloses an alphanumeric message visible by X-ray examination
`
`when the port is implanted to identify the port as power-injectable. Ex.1003, 3:43-
`
`47, 11:41-12:2; Ex.1016, p.7/65 (¶[0034]), p.8/65 (¶[0037]), p.17/65 (¶¶[0069]-
`
`[0070]), p.48/65 (Nos. 5-7).
`
`
`
`14
`
`

`
`26. An access port marked with alphanumeric characters as disclosed in
`
`Powers, when viewed using X-rays after implantation, would convey to a POSA
`
`that the access port is power injectable.
`
`27. Powers discloses “a flange feature or lip feature 102 extends about at least
`
`a portion of the periphery of the access port 10.” Ex.1003, 9:18-22; Ex.1016,
`
`p.15/65 (¶[0061]). Powers further discloses that such “a feature may comprise at
`
`least one identifiable feature of an access port contemplated by the instant
`
`disclosure.” Ex.1003, 9:25-27; Ex.1016, p.15/65 (¶[0061]).
`
`28. Powers discloses that “suture apertures 66 may be positioned so as to
`
`identify the access port 10 after subcutaneous implantation.” Ex.1003, 10:16-18,
`
`Fig. 20; Ex.1016, p.16/65 (¶[0067]), Fig 20.
`
`29. PowerPort (Ex.1004) is a printed publication which was publicly available
`
`at least as early as February 2007. Ex.1018, ¶¶9-26.
`
`30. One of the ports disclosed in PowerPort is the PowerPort*- M.R.I.*
`
`Device. The PowerPort*- M.R.I.* Device is a power injectable venous access port
`
`with a radiopaque identifier. Ex.1004.
`
`31. The radiopaque identifier utilized in the PowerPort*- M.R.I.* Device under
`
`X-ray examination is shown below:
`
`
`
`15
`
`

`
`32. PowerPort discloses a power injectable port marked with the alphanumeric
`
`
`
`characters “C” and “T”.
`
`33. The radiopaque identifier utilized in the PowerPort*- M.R.I.* Device is
`
`made from an X-ray discernable material.
`
`34. The radiopaque identifier utilized in the PowerPort*- M.R.I.* Device
`
`includes one or more voids which form the alphanumeric characters “C” and “T”
`
`which extend through the top surface of the X-ray discernable material to the
`
`bottom surface of the X-ray discernable material.
`
`35. The voids in the radiopaque identifier utilized in the PowerPort*- M.R.I.*
`
`Device are X-ray discernable indicia configured to indicate, under X-ray
`
`examination, that the assembly is rated for power injection, i.e., that the assembly
`
`is adapted to withstand higher pressures and increased flow rates used for injection
`
`of contrast fluid.
`
`36. Sayre states: “Indicia 124, also photoetched from the radiopaque material,
`
`aid in indicating orientation of each marker 116.” Ex.1007, 2:41-44; 4:8-10.
`
`37. Sayre discloses indicia 124 photoetched from radiopaque material or
`
`formed in radiopaque markers 116 by stamping, laser cutting, or by other means in
`
`
`
`16
`
`

`
`which the indicia 124 are defined by one or more apertures, such as in the form of
`
`alphanumeric characters, formed through the respective marker 116 to provide
`
`unique identifying information. Ex.1007, 4:11-31, Fig. 2A, claim 6.
`
`38. The radiopaque markers and indicia defined by one or more apertures
`
`disclose