UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
`and MEDTRONIC COREVALVE, LLC
`Petitioner
`
`v.
`
`TROY R. NORRED, M.D.
`Patent Owner
`
`____________
`
`Case IPR2014-00110
`Patent 6,482,228
`____________
`
`Attorney Docket No. 058888-0000014
`
`____________
`
`CORRECTED PETITION FOR INTER PARTES REVIEW
`UNDER 37 C.F.R. § 42.100
`
`
`
`

`
`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.  Related Matters Under 37 C.F.R. § 42.8(b)(2) ................................................ 1 
`C.  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) ......................................... 2 
`II.  PAYMENT OF FEES UNDER 37 C.F.R. § 42.103 ............................................ 2 
`III. SUMMARY OF THE ‘228 PATENT .................................................................. 3 
`A.  Description of the Alleged Invention of the ‘228 Patent ................................. 3 
`B.  Summary of the Prosecution History of the ‘228 Patent ................................. 6 
`IV.  REQUIREMENTS FOR INTER PARTES REVIEW UNDER 37 C.F.R. §§
`42.104 .................................................................................................................... 6 
`A.  Grounds for Standing Under 37 C.F.R. § 42.104(a) ....................................... 7 
`B.  Identification of Challenge Under 37 C.F.R. § 42.104(b) and Relief
`Requested ......................................................................................................... 7 
`C.  Claims for Which Inter Partes Review Is Requested Under 37 CFR §
`42.104(b)(1) ..................................................................................................... 7 
`D.  The Specific Art and Statutory Ground(s) on Which the Challenge Is Based
`Under 37 C.F.R. § 42.104(b)(2) ...................................................................... 8 
`E.  How the Challenged Claims Are to Be Construed Under 37 C.F.R.
`§42.104(b)(3) ................................................................................................... 8 
`1.  “membrane” ................................................................................................ 8 
`2.  “Means for mounting” ................................................................................ 9 
`3.  “Means for maintaining” .......................................................................... 10 
`F.  How the Construed Claim(s) Are Unpatentable Under 37 C.F.R. §
`42.104(b)(4) ................................................................................................... 11 
`G.  Supporting Evidence Under 37 C.F.R. § 42.104(b)(5) ................................. 11 
`V.  DETAILED EXPLANATION OF PERTINENCE AND MANNER OF
`APPLYING CITED PRIOR ART TO EVERY CLAIM FOR WHICH
`REVIEW IS REQUESTED UNDER 37 C.F.R. § 42.104(b) (4) ....................... 11 
`A.  Claims 16-19 are Anticipated Under 35 U.S.C. §102(e) by U.S. Patent No.
`6,440,164 to DiMatteo (Exh. 1003) ............................................................... 11 
`
`

`
`B.  Claims 16-18 are Anticipated Under 35 U.S.C. §102(b) by U.S. Patent No.
`3,548,417 to Kischer (Exh. 1004).................................................................. 13 
`C.  Claims 16-19 are Anticipated Under 35 U.S.C. §102(e) by U.S. Patent No.
`6,299,637 to Shaolian (Exh. 1005) ................................................................ 14 
`D.  Claims 16-18 are Anticipated Under 35 U.S.C. §102(b) by U.S. Patent No.
`4,030,142 to Wolfe (Exh. 1006) .................................................................... 15 
`VI.  CONCLUSION .............................................................................................. 16 
`
`
`ii
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`

`
`Exhibit List for Inter Partes Review of U.S. Patent No. 6,482,228
`
`Exhibit Description
`U.S. Patent No. 6,482,228 to Norred
`File History for U.S. Patent No. 6,482,228
`U.S. Patent No. 6,440,164 to DiMatteo
`U.S. Patent No. 3,548,417 to Kischer
`U.S. Patent No. 6,299,637 to Shaolian et al.
`U.S. Patent No. 4,030,142 to Wolfe
`
`Exhibit No.
`1001
`1002
`1003
`1004
`1005
`1006
`
`iii
`
`

`
`Inter partes review is respectfully requested for claims 16-19 of U.S. Patent
`
`No. 6,482,228 (“the ‘228 Patent”) (Exh. 1001).
`
`I. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1)
`The following mandatory notices are provided as part of this Petition.
`
`A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1)
`Medtronic, Inc., Medtronic Vascular, Inc., and Medtronic CoreValve, LLC1
`
`(collectively “Petitioner”) are the real parties-in-interest.
`
`B. Related Matters Under 37 C.F.R. § 42.8(b)(2)
`The ’228 Patent is presently the subject of litigation brought by the Patent
`
`Owner against Petitioner in the U.S. District Court for the District of Kansas in a
`
`case titled Troy R. Norred. M.D. v. Medtronic, Inc., et al., No. 2:13-cv-02061
`
`(Feb. 6, 2013). In addition, the ‘228 Patent is the subject of IPR2014-00111, which
`
`is concurrently filed with this petition.
`
`C. Lead and Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`Petitioner provides the following designation of counsel:
`
`
`
`
`1 On or about April 9, 2009, CoreValve, Inc. merged into Medtronic-CoreValve,
`
`Inc., which was subsequently renamed Medtronic CoreValve, LLC, and is there-
`
`fore not identified as a separate petitioner.
`
`

`
`Lead Counsel
`
`Back-Up Counsel
`
`Jack Barufka (Reg. No. 37,087)
`
`Evan Finkel (Reg. No. 49,059)
`
`PILLSBURY WINTHROP SHAW
`
`PILLSBURY WINTHROP SHAW
`
`PITTMAN LLP
`
`PITTMAN LLP
`
`Postal and Hand Delivery Address
`
`Postal and Hand Delivery Address
`
`1650 Tysons Boulevard
`
`725 S. Figueroa Street, Suite 2700
`
`McLean, Virginia 22102
`
`Los Angeles, California 90017
`
`Telephone: 703.770.7712
`
`Telephone: 213.488.7307
`
`Facsimile: 703.906.2500
`
`Facsimile: 213.226.4058
`
`Email: jack.barufka@pillsburylaw.com
`
`Email: evan.finkel@pillsburylaw.com
`
`
`
`Service Information Under 37 C.F.R. § 42.8(b)(4)
`
`D.
`Service of any documents via hand-delivery may be made at the postal mail-
`
`ing address of the respective lead or back-up counsel designated above with cour-
`
`tesy email copies to the email addresses and docket_ip@pillsburylaw.com.
`
`II.
`
`PAYMENT OF FEES UNDER 37 C.F.R. § 42.103
`
`The undersigned authorizes the Office to charge Deposit Account No.
`
`033975 for the fee set forth in 37 C.F.R. § 42.15(a), or any other applicable fees,
`
`for this Petition for inter partes review. The undersigned further authorizes pay-
`
`
`
`2
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`

`
`ment for any additional fees that might be due in connection with this Petition to be
`
`charged to the above-referenced Deposit Account.
`
`III. SUMMARY OF THE ‘228 PATENT
`A. Description of the Alleged Invention of the ‘228 Patent
`The ‘228 Patent (Exh. 1001) contains 24 claims, including four independent
`
`apparatus claims (claims 1, 12, 16, and 20). The ‘228 Patent relates to a percutane-
`
`ous aortic heart valve replacement that is placed by a catheter in the ascending aor-
`
`ta and held in place with a stent system. ‘228 Patent, 1: 6-9. Shown below is an
`
`annotated version of Figure 4 showing the placement of Replacement Aortic Valve
`
`30 and Stent System 28 in the ascending aorta.
`
`The ‘228 Patent discloses four replacement valve designs that can be secured
`
`in a stent system: an umbrella valve 30 (Figs. 1-9); a conical valve 66 (Figs. 10-
`
`
`
`
`
`3
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`

`
`13); a trihedral valve 82 (Figs. 14-17); and biological tissue, such as cadaver or
`
`porcine, valves 100 (Figs. 18-19). The ’228 patent explains what is well known in
`
`the art: that the replacement valves operate like a native aortic valve. That is, when
`
`the heart contracts (systole) the valve opens to allow blood exiting the left ventricle
`
`to flow through the valve and when the heart relaxes (diastole) the valve closes to
`
`prevent regurgitation. The ’228 discloses that each of these replacement valve de-
`
`signs, when anchored in a stent system, would be disposed against the aorta wall to
`
`reduce or eliminate peri-valvular leaks.
`
`With respect to independent claim 16 and its dependent claims 17-19, the
`
`‘228 Patent’s alleged invention is a valve (see annotated Figures 10 and 16 below)
`
`for controlling blood flow through an aortic channel. ‘228 Patent, 7:59- 8:12.
`
`
`
`Figure 10 above shows a conical valve which has a Ring-Shaped Base 70
`
`made of a pliable biocompatible material with a circumference adapted to seat
`
`about an aortic wall surrounding an aortic channel such that blood flows through a
`
`
`
`4
`
`

`
`center opening in Ring-Shaped Base 70. ‘228 Patent, 5:9-20. Fingers 68 are gener-
`
`ally wedge or bowling pin-shaped, constructed of stainless steel, plastic or other
`
`biocompatible material, and are hingedly secured to Ring-Shaped Base 70 by Ring
`
`72. ‘228 Patent, 4:57-64. A “biocompatible, durable, flexible generally conically-
`
`shaped fabric 75 membrane” is secured to the inside surfaces of Fingers 68 and is
`
`used to interconnect Fingers 68. Id. The valve is anchored along the root of the aor-
`
`tic valve with Connecting Rods 80 which are connected to an aortic stent. ‘228 Pa-
`
`tent, 5:21-23.
`
`Figure 16 above shows a trihedral valve with similar structures and opera-
`
`tion to the conical valve, including Arms/Rods 84 hingedly connected to Base 88
`
`by Ring 86 and interconnected to each other by Membrane 92. ‘228 Patent, 5:33-
`
`62. Each Arm/Rod 84 has a crescent-shaped pad 90 at its free end. Id. The trihe-
`
`dral valve is also anchored along the root of the aortic valve with connecting rods
`
`(not shown). ‘228 Patent, 5:48-51.
`
`Figure 10 above shows the conical valve in closed position with the tips 76
`
`of Fingers 68 contacting each adjacent tip to prevent regurgitation (i.e., the flow of
`
`blood from the aorta back into the left ventricle). ‘228 Patent, 4:65-67. During sys-
`
`tole the valve expands or opens to allow blood ejected from the left ventricle to
`
`flow through the center of the valve. ‘228 Patent, 5:9-14. Fingers 68 pivot on Ring
`
`72 and tips 76 separate to allow blood to flow through the center of the valve.
`
`
`
`5
`
`

`
`Membrane 75 prevents Fingers 68 from overextending to block coronary arteries
`
`38. Id. The trihedral valve operates in a similar manner and is shown in the open
`
`position in Figure 16 above. ‘228 Patent, 5:43-47.
`
`Summary of the Prosecution History of the ‘228 Patent
`
`B.
`Referring to the prosecution history of the ‘228 Patent (Exh. 1002), the ‘228
`
`Patent was filed as U.S. App. Serial No. 09/712,121 on Nov. 14, 2000 (see Exh.
`
`1002, paper 1). The ‘228 Patent does not claim priority to any earlier filed applica-
`
`tions. Although claims 16-24 (originally claims 19-27) were not addressed in the
`
`first Office Action mailed on Aug. 9, 2001 (id., paper 3, “August 2001 Office Ac-
`
`tion”), the Examiner stated in a Jan. 30, 2002 personal interview (id., paper 4) with
`
`applicant that “Claims 19-27 should have been stated as allowable in the 8/9/01 ac-
`
`tion.” In response to the August 2001 Office Action, applicant filed an amendment
`
`on Feb. 26, 2002 (id., paper 5) that, among other things, ostensibly made non-
`
`substantive grammatical amendments to improve the language of claims 16-24.
`
`The Examiner subsequently issued a Notice of Allowability on Apr. 2, 2002 (id.,
`
`paper 4) that included a few Examiner amendments to the claim language.
`
`IV. REQUIREMENTS FOR INTER PARTES REVIEW UNDER 37 C.F.R.
`§§ 42.104
`
`As set forth below and pursuant to 37 C.F.R. § 42.104, each requirement for
`
`inter partes review of the ‘228 Patent is satisfied.
`
`
`
`
`
`6
`
`

`
`
`
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)
`Petitioner hereby certifies that the ‘228 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 ‘228 Patent on the grounds identified herein.
`
`More particularly, Petitioner certifies that: (1) Petitioner is not the owner of the
`
`‘228 Patent; (2) Petitioner has not filed a civil action challenging the validity of a
`
`claim of the ‘228 Patent; (3) this Petition is filed less than one year after the date
`
`on which the Petitioner, the Petitioner’s real party-in-interest, or a privy of the Peti-
`
`tioner was served with a complaint alleging infringement of the ‘228 Patent; (4) the
`
`estoppel provisions of 35 U.S.C. § 315(e)(1) do not prohibit this inter partes re-
`
`view; and (5) this Petition is filed after the later of (a) the date that is nine months
`
`after the date of the grant of the ‘228 Patent or (b) the date of termination of any
`
`post-grant review of the ‘228 Patent.
`
`B.
`
`Identification of Challenge Under 37 C.F.R. § 42.104(b) and Relief
`Requested
`
`The precise relief requested by Petitioner is that claims 16-19 of the ‘228 Pa-
`
`tent be found unpatentable.
`
`C. Claims for Which Inter Partes Review Is Requested Under 37
`CFR § 42.104(b)(1)
`Inter partes review of claims 16-19 of the ‘228 Patent is requested.
`
`
`
`7
`
`

`
`D. The Specific Art and Statutory Ground(s) on Which the Chal-
`lenge Is Based Under 37 C.F.R. § 42.104(b)(2)
`
`Inter partes review is requested in view of the following references and spe-
`
`cific grounds for rejection under 35 U.S.C. §102:
`
`No.
`1
`2
`3
`4
`
`Grounds
`Claims 16-19 are anticipated by US 6,440,164 (“DiMatteo”)
`Claims 16-18 are anticipated by US 3,548,417 (“Kischer”)
`Claims 16-19 are anticipated by US 6,299,637 (“Shaolian”)
`Claims 16-18 are anticipated by US 4,030,142 (“Wolfe”)
`
`Each reference and grounds listed above establishes a reasonable likelihood
`
`that Petitioner will prevail on at least one claim and thus this petition for inter
`
`partes review should be granted.
`
`E. How the Challenged Claims Are to Be Construed Under 37 C.F.R.
`§42.104(b)(3)
`
`Petitioner notes that a claim is given the “broadest reasonable construction in
`
`light of the specification” in inter partes review. See 37 C.F.R. § 42.100(b). As de-
`
`scribed in Section III.A above, the ‘228 Patent is directed to artificial aortic heart
`
`valve replacements that can be anchored in place with a stent system and discloses
`
`four such replacement valve embodiments.
`
`“membrane”
`
`1.
`The term “membrane” is used in claims 16 and 17. It is expected that the
`
`Patent Owner will stretch the meaning of this term to not only refer to materials
`
`such as fabrics or polymers, but also to include “tissue.” That is therefore the way
`
`this term is applied for the purposes of inter partes review. However, it should be
`
`
`
`8
`
`

`
`noted that the ‘228 Patent draws a distinction between the terms “material” and
`
`“tissue.” The specification only refers to a “membrane” in describing the cone-
`
`shaped valve embodiments, with the first cone-shaped valve embodiment having
`
`“a biocompatible, durable, flexible generally conically-shaped fabric 75 mem-
`
`brane” and the second cone-shaped valve embodiment having “[a] cone-shaped
`
`membrane 92 of fibrous polymer.” ‘228 Patent, 4:59-62 and 5:40-41(emphasis
`
`added). In contrast, the specification’s only reference to “tissue” is in the context
`
`of describing “other valvular designs” that “include the usage biological tissue in-
`
`corporated valves, such as cadaver/porcine valves.” ‘228 Patent, 5:64-65. Thus,
`
`Petitioner submits that the term “membrane” will more appropriately be construed
`
`in litigation to include fabrics or polymers, but not tissue.
`
`“Means for mounting”
`
`2.
`Claim 16 recites a “means for mounting said first open end of said mem-
`
`brane about said ring aperture with said second open end displaced therefrom.”
`
`This limitation is a “means plus function” limitation to be construed under 35
`
`U.S.C. § 112, ¶6. The ‘228 Patent describes the “means” for performing the
`
`claimed function as follows:
`
`“The fingers 68 are generally wedge or bowling pin-shaped and are
`hingedly secured together by ring 72 extending through the base 74 of
`each finger 68 and interconnected by a biocompatible, durable, flexi-
`
`
`
`9
`
`

`
`ble generally conically-shaped fabric 75 membrane secured to the in-
`side surfaces 69 of the fingers.” (‘228 Patent, 4:56-61).
`“Arms 84 are hingedly attached to ring 86 of base 88 and extend up-
`wardly and radially inwardly from base 88 to generally form a trihe-
`dron or cone…A cone-shaped membrane 92 of fibrous polymer is se-
`cured to each arm 84 and base 88 (not shown in FIG. 14).” (‘228 Pa-
`tent, 5:36-42).
`
`Therefore, the ‘228 Patent’s specification supports an interpretation of the
`
`“means” for performing the claimed function as “fingers or arms hingedly attached
`
`to a ring” or an equivalent structure. That construction is also consistent with the
`
`structure of the “means” recited in dependent claim 17 as “at least one arm having
`
`a first end hingedly secured to said ring member”
`
`“Means for maintaining”
`
`3.
`Claim 19 recites a “means for maintaining said ring member in said seat
`
`about the aortic wall.” This limitation is to be construed as a “means plus function”
`
`limitation under 35 U.S.C. § 112, ¶6. Regarding the embodiment corresponding to
`
`claim 19, the ‘228 Patent describes the “means” for performing the claimed func-
`
`tions as follows: “Valve 66 is anchored along the root of the aortic valve with con-
`
`necting rods 80” and “Valve 82 is anchored along the aortic valve root wall with
`
`connecting rods (not shown; see connecting rods 80, Fig. 10).” ‘228 Patent, 5:21-
`
`22 & 48-49. Therefore, the ‘228 Patent’s specification supports an interpretation
`
`
`
`10
`
`

`
`of the “means” for performing the claimed function as “connecting rods” or an
`
`equivalent structure.
`
`F. How the Construed Claim(s) Are Unpatentable Under 37 C.F.R. §
`42.104(b)(4)
`
`An explanation of how construed claims 16-19 of the ‘228 Patent are un-
`
`patentable under the statutory grounds identified above, including identification of
`
`where each element of the claim is found in the prior art patents or printed publica-
`
`tions, is provided in Section V and in claim charts A-1 to A-4.
`
`Supporting Evidence Under 37 C.F.R. § 42.104(b)(5)
`
`G.
`The exhibit numbers of the supporting evidence relied upon to support the
`
`challenge and the relevance of the evidence to the challenge, including identifica-
`
`tion of specific portions of the evidence that support the challenge, are provided
`
`below in Section V and in claim charts A-1 to A-4.
`
`V. DETAILED EXPLANATION OF PERTINENCE AND MANNER OF
`APPLYING CITED PRIOR ART TO EVERY CLAIM FOR WHICH
`REVIEW IS REQUESTED UNDER 37 C.F.R. § 42.104(b) (4)
`A. Claims 16-19 are Anticipated Under 35 U.S.C. §102(e) by U.S. Pa-
`tent No. 6,440,164 to DiMatteo (Exh. 1003)
`
`U.S. Patent No. 6,440,164 to DiMatteo et al. (“DiMatteo”) was filed on Oc-
`
`tober 21, 1999 and thus qualifies as prior art under § 102(e). DiMatteo was not cit-
`
`ed during prosecution of the ‘228 Patent although it describes a prosthetic aortic
`
`valve with hinged leaflets that control blood flow through the valve. DiMatteo,
`
`1:4-6, 3:18-27. The claim chart attached as Appendix A-1 details how each ele-
`
`
`
`11
`
`

`
`ment recited in claims 16-19 is anticipated by DiMatteo. Figure 1 below shows one
`
`embodiment of the valve in a closed position where Leaf Valve Portion 14 is con-
`
`nected to Tubular Body Portion 12 at a Hinge Line 22. Figure 3 below shows the
`
`same embodiment, but with the valve in an open position and Valve Leafs 40
`
`spread to allow blood to flow through Tubular Body Portion 12. Figure 16 below
`
`shows another embodiment where Valve Leafs 40 are interconnected with Web-
`
`bing 84. DiMatteo, 11:10-15.
`
`
`
`
`
`
`
`As shown below in Figure 17, DiMatteo further teaches that the valve can be
`
`secured in place by mechanically joining the valve to a Second Scaffold 150 (e.g.,
`
`stent) via a wire 114. DiMatteo, 13:43-51.
`
`
`
`12
`
`
`
`

`
`
`
`B. Claims 16-18 are Anticipated Under 35 U.S.C. §102(b) by U.S. Pa-
`tent No. 3,548,417 to Kischer (Exh. 1004)
`
`U.S. Patent No. 3,548,417 to Kischer (“Kischer”) issued on December 22,
`
`1970 and thus qualifies as prior art under § 102(b). Kischer was not cited during
`
`prosecution of the ‘228 Patent although it describes a prosthetic aortic valve with a
`
`frusto-conical sheet material connected to ribs that rotate radially about a base ring.
`
`Kischer, 1:67-69 and 2:1-30. The claim chart attached as Appendix A-2 details
`
`how each element recited in claims 16-18 is anticipated by Kischer. Figures 6 and
`
`8 below show the valve in open and closed positions, respectively. As shown in the
`
`figures, Ribs 22 are attached to Wall 18, which is attached to annular Base 16
`
`through which blood flows. The stiffening support for the sheet material (e.g., Ribs
`
`22) induces “the material [Wall 18] to rotate in its movement between its first and
`
`second position.” Kischer, 2:14-20. The pressure differential caused by the heart as
`
`it pumps blood forces the valve to open and close with Wall 18 rotating relative to
`
`Base 16 and at least partially about the axis of the wall. Kischer, 4:37-63.
`
`
`
`13
`
`
`
`

`
`
`
`C. Claims 16-19 are Anticipated Under 35 U.S.C. §102(e) by U.S. Pa-
`tent No. 6,299,637 to Shaolian (Exh. 1005)
`
`U.S. Patent No. 6,299,637 to Shaolian et al. (“Shaolian”) was filed on Au-
`
`gust 20, 1999 and thus qualifies as prior art under § 102(e). Shaolian was not cited
`
`during prosecution of the ‘228 Patent although it describes a valve with hinged
`
`valve leaflets within a tubular support structure that may be utilized as a venous
`
`valve or elsewhere in the body. Shaolian, 4:35-41 and 9:40-67. The claim chart
`
`attached as Appendix A-3 details how each element recited in claims 16-19 is an-
`
`ticipated by Shaolian. Figure 6 below shows a valve embodiment that is referred to
`
`as the “two leaflet ‘duck bill’” which comprises Leaflets 76 and 78 that comprise
`
`“flexible wire struts, covered by a blood flow blocking membrane such as PTFE or
`
`Dacron.” Shaolian 9:44-46. Figure 4 below shows a tubular wireframe for support-
`
`ing the prosthetic valve. “Each of the leaflets 76 and 78 are rotatably connected to
`
`the inside wall of a tubular wire frame 44.” Shaolian 9:47-49. Leaflets 76 and 78
`
`control blood flow through tubular wireframe 44 by pivoting towards each other to
`
`close the valve and away from each other to open the valve. Shaolian, 9:50-59.
`
`
`
`14
`
`

`
`
`
`
`
`Shaolian further teaches that the center section 52 of the tubular wireframe
`
`44, which is connected to the valve leaflets 76 and 78, can be connected to addi-
`
`tional sections 50 and 54 by connectors 56 and 58 respectively. Shaolian, 6:60-62.
`
`D. Claims 16-18 are Anticipated Under 35 U.S.C. §102(b) by U.S. Pa-
`tent No. 4,030,142 to Wolfe (Exh. 1006)
`
`U.S. Patent No. 4,030,142 to Wolfe (“Wolfe”) issued on June 21, 1977 and
`
`thus qualifies as prior art under § 102(b). Wolfe was not cited during prosecution
`
`of the ‘228 Patent although it describes a prosthetic heart valve that can be adapted
`
`to replace an aortic valve. The claim chart attached as Appendix A-4 details how
`
`each element recited in claims 16-18 is anticipated by Wolfe. Shown below in Fig-
`
`ures 2B (closed position) and 2C (open position) is one embodiment of the heart
`
`valve taught in Wolfe. Cuspids 38, which are formed of a plastic material such as
`
`polypropylene, move radially to control the flow of blood through the valve. Wolfe,
`
`1:60-2:4. Each Cuspid 38 is connected to an Upstream Annular Section 40 through
`
`an Armature Construction 54 that is hingedly connected to Annular Ring 56.
`
`
`
`15
`
`

`
`Wolfe, 5:27-45. The valve is held in place by Valve Seat Assembly 14, which in-
`
`cludes a Fixation Cover 20 that is sutured to the heart tissue. Wolfe, 3:51-64.
`
`
`
`
`
`VI. CONCLUSION
`Based on the foregoing, it is clear that claims 16-19 of the ‘228 Patent define
`
`subject matter that is anticipated. The art cited above was never considered by the
`
`original Examiner, and if it had been claims 16-19 of the ‘228 Patent would not
`
`have issued. The art cited above establishes a reasonable likelihood that Petitioner
`
`will prevail on at least one claim. Thus, the Petitioner requests institution of an in-
`
`ter partes review to cancel those claims.
`
`
`
`16
`
`

`
`Respectfully submitted,
`
`PILLSBURY WINTHROP SHAW PITTMAN LLP
`
`/Jack Barufka/
`
`Jack S. Barufka
`Reg. No. 37,087
`Tel. No. 703.770.7712
`Fax No. 703.905.2500
`
`
`P.O. Box 10500
`McLean, VA 22102
`(703) 770-7900
`
`
`Attachments:
`
`
`
`
`Appendices A-1 – A-4 (Claim Charts)
`Exhibits 1001-1006
`
`
`
`
`17
`
`

`
`The ‘228 Patent Appendix A-1: Anticipation By US 6,440,164 to DiMatteo
`(Exh. 1003)
`To the extent that the preamble is limitation, DiMatteo dis-
`closes a prosthetic aortic valve for regulating blood flow upon
`placement in the aorta. 1:4-6 and 2:26-31.
`
`16. An aortic
`valve for regulat-
`ing a blood flow
`through an aortic
`channel surround-
`ed by an aortic
`wall upon place-
`ment therein, said
`valve comprising:
`a ring member
`having a circum-
`ference adapted to
`seat about an aor-
`tic wall surround-
`ing an aortic
`channel, said ring
`including an aper-
`ture for blood flow
`therethrough;
`
`[1] DiMatteo discloses a ring member in the form of a “tubu-
`lar body portion 12.” [2] The tubular body portion 12 (“ring
`member”) has a circumference adapted to seat about an aortic
`wall surrounding an aortic channel in that it provides “fluid-
`tight engagement with the body lumen” such as an aortic
`channel [3] to regulate the flow of blood flowing through the
`tubular body portion 12 (“ring member”). 3:29-33 and 7:38-
`49. Fig. 1 below shows tubular body portion 12 (“ring mem-
`ber”). Fig. 4 below is a top view of the valve in an open posi-
`tion showing an “aperture for blood flow therethrough” in the
`form of passageway 20.
`
`
`
`Appendix - 1
`
`

`
`The ‘228 Patent Appendix A-1: Anticipation By US 6,440,164 to DiMatteo
`(Exh. 1003)
`
`a membrane hav-
`ing first and sec-
`ond spaced-apart
`open ends, said
`membrane made
`of a material re-
`sistant to a fluid
`flow therethrough;
`and
`
`
`[1] DiMatteo discloses a membrane in the form of “valve leaf
`covers” and “webbing” attached to leaf frame 52 (“arm”). [2]
`As shown in Fig. 16, the valve leaf cover 80 and webbing 84
`(together the “membrane”) have a first open end at passage-
`way 20 (“ring aperture”) of tubular body portion 12 (“ring
`member”) and [3] a second open end at downstream opening
`50, with such ends being spaced apart as shown. [4] The valve
`leaf covers (which form part of the “membrane”) are a “fluid-
`impermeable biocompatible non-thrombogenic” material.
`2:48-50 and 10:26-41. The webbing (which forms the other
`part of the “membrane”) is made of the same material as inner
`liner 82 (not shown), which can be “polymeric” or “tissue,”
`and is resistant to fluid flow as it is intended to “provide a
`larger surface area for the body fluid to act upon when urging
`the valve leafs 40 between the open and closed configura-
`tion.” 11:10-15 and 36-55.
`
`
`
`Appendix - 2
`
`

`
`The ‘228 Patent Appendix A-1: Anticipation By US 6,440,164 to DiMatteo
`(Exh. 1003)
`
`means for mount-
`ing said first open
`end of said mem-
`brane about said
`ring aperture with
`said second open
`end displaced
`therefrom, said
`means moving
`said membrane
`second end be-
`tween a first open
`
`[1] As noted above in Section IV.E.3, the claimed “means for
`mounting” disclosed in the ‘228 Patent comprises fingers or
`arms hingedly attached to a ring. As shown above in Fig. 3,
`DiMatteo discloses a leaf frame or “arm” 52 hingedly at-
`tached to tubular body portion 12 (“ring member”). The leaf
`frame 52 (“arm”) is covered with leaf cover 80 and webbing
`84 (“membrane”) which is hingedly attached to hinge line 22
`about passageway 20 (“ring aperture”) of tubular body portion
`12 (“ring member”). 7:24-55 and 11:9-15. [2] DiMatteo dis-
`closes that leaf frame 52 (“arms”) deflects leaf cover 80 and
`webbing 84 (“membrane”) between open and closed posi-
`tions. 3:18-27 and 7:33-36. As shown in Figs. 3 and 4, valve
`
`
`
`Appendix - 3
`
`

`
`The ‘228 Patent Appendix A-1: Anticipation By US 6,440,164 to DiMatteo
`(Exh. 1003)
`leafs 40 containing leaf frames 52 (“arms”) have moved apart
`and extend generally along a path blood flow to in a first open
`position. [3] DiMatteo further discloses that these arms gener-
`ally traverse a blood flow path when at a second closed posi-
`tion. Fig. 1 show valve leafs 40 containing leaf frames 52
`(“arms”) generally traversing a blood flow path in a closed
`position. See also 2:34-38, 6:63-37, 7:7-12.
`[1] As explained above in claim 16, DiMatteo discloses a
`mounting means including “at least one arm” in the form of
`leaf frame 52. [2] As shown in Figs. 3 and 16 above, the leaf
`frame 52 (“arms”) in DiMatteo is hingedly connected at hinge
`line 22 to tubular body portion 12 (“ring member”) with a
`free downstream end that moves radially between an open and
`closed position. 7:24-55 and 11:9-15. [3] Figs. 3 and 16 fur-
`ther show that leaf cover 80 and webbing 84 (“membrane”)
`are attached to the leaf frame 52 (“arm”) at both the hinge line
`22 and second end 55. See also 2:34-38, 3:18-27, 6:63-37, and
`7:7-12, 24-55, and 11:9-15. [4] DiMatteo further discloses
`that leaf frame 52 (“arms”) move between open and closed
`positions in response to fluid pressure differentials: “the fluid
`pressure differential acts to open the valve when the fluid
`pressure upstream of the valve leaf portion is greater than the
`fluid pressure downstream of the valve leaf portion” and
`“[w]hen the pressure differential is too low, the valve closes
`to prevent back flow.” 3:18-27, 6:53-67, and 7:4-12, 33-36.
`
`position to allow a
`blood flow
`therethrough and a
`second closed po-
`sition to preclude
`a blood flow
`therethrough.
`17. The aortic
`valve as claimed
`in claim 16 where-
`in said mounting
`means comprises
`at least one arm
`having a first end
`hingedly secured
`to said ring mem-
`ber and a free end
`spaced therefrom,
`said first end of
`said at least one
`arm secured to
`said first end of
`said membrane,
`said free end of
`said at least one
`arm secured to
`said second end of
`said membrane,
`said at least one
`arm responsive to
`a blood flow with-
`in the channel for
`movement with
`said membrane
`between said first
`open and second
`closed positions.
`
`
`
`Appendix - 4
`
`

`
`18. The aortic
`valve as claimed
`in claim 17 where-
`in said at least one
`arm extends gen-
`erally along a path
`of said blood flow
`at said first open
`position, and gen-
`erally traverses a
`blood flow path
`when at said sec-
`ond closed posi-
`tion.
`19. The aortic
`valve as claimed
`in claim 16 further
`comprising means
`for maintaining
`said ring member
`in said seat about
`the aortic wall.
`
`The ‘228 Patent Appendix A-1: Anticipation By US 6,440,164 to DiMatteo
`(Exh. 1003)
`[1] As explained in claim 17 above, DiMatteo discloses “at
`least one arm” in the form of leaf frame 52. [2] DiMatteo fur-
`ther discloses that these arms extend generally along a path of
`said blood flow at a first open position. Fig. 3 shows leaf
`frame 52 (“arms”) generally along the blood flow path in an
`open position. See also 2:34-38, 3:18-27, 6:53-67, and 7:4-12,
`33-36. [3] DiMatteo further discloses that these arms general-
`ly traverse a blood flow path when at a second closed posi-
`tion. Fig. 1 shows leaf frame 52 (“arms”) generally traversing
`a blood flow path in a closed position. See also 2:34-38, 3:18-
`27, 6:53-67, and 7:4-12, 33-36.
`
`[1] As explained in claim 16 above, DiMatteo discloses “ring
`member” in the form of tubular body portion 12. [2] As noted
`above in Section IV.E.4, the claimed “means for maintaining”
`disclosed in the ‘228 Patent comprises connecting rods. Di-
`Matteo discloses a connecting rod in the form of a wire 114
`that connects the valve’s tubular body portion 12 (“ring mem-
`ber”) to a collapsible scaffold 150. See Fig. 17 below and
`13:43-51. [3] The position of the tubular body portion 12
`(“ring member”) is maintained in its seat about the aortic wall
`by being mechanically joined via wire 114 (“connecting rod”)
`to a second scaffold 150 which is designed to engage the tis-
`sue of the aorta and provide additional support to the valve.
`See also 3:29-33.
`
`
`
`Appendix - 5
`
`
`
`
`
`

`
`Appendix A-2: Anticipation By US 3,548,417 to Kischer
`(Exh. 1004)
`To the extent that the preamble is a limitation, Kischer dis-
`closes a “prosthetic heart valve suitable for the replacement
`of any of the natural heart valves” including an aortic valve.
`1:13-20 and 67-69.
`
`[1]