`
`
`
`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
`Patent Owner
`
`____________
`
`Case IPR2014-00395
`Patent 6,482,228
`____________
`
`Attorney Docket No. 058888-0000019
`____________
`
`
`CORRECTED PETITION FOR INTER PARTES REVIEW
`UNDER 37 C.F.R. § 42.100
`
`
`
`
`

`

`
`
`TABLE OF CONTENTS
`
`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 
`PAYMENT OF FEES UNDER 37 C.F.R. § 42.103 ....................................... 2 
`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 ......................................................................................... 8 
`A.  Grounds for Standing Under 37 C.F.R. § 42.104(a) ............................. 8 
`B. 
`Identification of Challenge Under 37 C.F.R. § 42.104(b) and
`Relief Requested .................................................................................... 9 
`Claims for Which Inter Partes Review Is Requested Under
`37 CFR § 42.104(b)(1) .......................................................................... 9 
`The Specific Art and Statutory Grounds on Which the Challenge
`Is Based Under 37 C.F.R. § 42.104(b)(2) ............................................. 9 
`How the Challenged Claims Are to Be Construed Under
`37 C.F.R. § 42.104(b)(3) ..................................................................... 10 
`1. 
`“Membrane” .............................................................................. 12 
`2. 
`“Means for mounting” .............................................................. 13 
`3. 
`“Tissue Valve” .......................................................................... 14 
`4. 
`“Means for maintaining” ........................................................... 14 
`How the Construed Claims Are Unpatentable Under
`37 C.F.R. § 42.104(b)(4) ..................................................................... 14 
`Supporting Evidence Under 37 C.F.R. § 42.104(b)(5) ....................... 15 
`G. 
`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) ................... 15 
`
`C. 
`
`D. 
`
`E. 
`
`F. 
`
`I. 
`
`II. 
`III. 
`
`
`
`

`

`
`
`A. 
`
`D. 
`
`Claims 16 and 19-24 are Anticipated Under 35 U.S.C. §102(b) by
`US 5,957,949 to Leonhardt et al. (Exh. 1004) .................................... 15 
`Claims 16 and 19-24 are Anticipated Under 35 U.S.C. §102(b) by
`US 5,411,552 to Andersen et al. (Exh. 1005) ..................................... 17 
`Claims 16 and 19-24 are Anticipated Under 35 U.S.C. §102(e) by
`US 6,458,153 to Bailey (Exh. 1006) ................................................... 19 
`Claims 16 and 19 are Anticipated Under 35 U.S.C. §102(b) by DE
`Patent Application No. 195 46 692 to Figulla (Exhs. 1007 & 1008) .. 22 
`Claims 16 and 19 are Anticipated Under 35 U.S.C. §102(b) by
`US 5,855,597 to Jayaraman (Exh. 1009) ............................................ 24 
`Claims 16 and 19 are Anticipated Under 35 U.S.C. §102(b) by
`US 3,657,744 to Ersek (Exh. 1010) .................................................... 26 
`VI.  CONCLUSION .............................................................................................. 27 
`
`
`B. 
`
`C. 
`
`E. 
`
`F. 
`
`ii
`
`

`

`
`
`Exhibit List for Inter Partes Review of U.S. Patent No. 6,482,228
`
`Exhibit Description
`U.S. Patent 6,482,228 to Norred
`File History for U.S. Patent 6,482,228 to Norred
`Patent Owner’s Initial Infringement Contentions
`U.S. Patent 5,957,949 to Leonhardt et al.
`U.S. Patent 5,411,552 to Andersen et al.
`U.S. Patent 6,458,153 to Bailey et al.
`German Patent App. No. DE 195-46-692 to Figulla et al. - Applica-
`tion as Filed
`Translation of German Patent App. No. DE 195-46-692 to Figulla et
`al. - Application as Filed (with a certification from Abraham I.
`Holczer attesting to the accuracy of the translation)
`U.S. Patent 5,855,597 to Jayaraman
`U.S. Patent 3,657,744 to Ersek
`Declaration of Felix Harbsmeier with attached exhibits (1-5):
`Exhibit 1: German Patent No. DE 195-46-692 C2 as granted on
`November 7, 2002 [also attached at Exh. 1012].
`Exhibit 2: The complete prosecution history for patent DE 195-
`46-692 C1 [also attached at Exh. 1013].
`Exhibit 3: German Patent App. No. DE 195-46-692 as filed on
`December 14, 1995 [also attached at Exh. 1007, with certified
`English translation at Exh. 1008].
`Exhibit 4: German Patent App. No. DE 195-46-692 A1 as pub-
`lished on June 19, 1997 [also attached at Exh. 1014, with cer-
`tified English translation at Exh. 1015].
`Exhibit 5: Sections 31 and 32 of the German Patent Act in effect
`as of June 19, 1997 through November 14, 2000 [also at-
`tached at Exh. 1016, with certified English translation at Exh.
`1017].
`German Patent No. DE 195-46-692 C2
`German Patent No. DE 195-46-692 C1 Prosecution History
`German Patent App. No. DE 195-46-692 A1 to Figulla et al.
`
`iii
`
`Exhibit No.
`1001
`1002
`1003
`1004
`1005
`1006
`1007
`
`1008
`
`1009
`1010
`1011
`
`1012
`1013
`1014
`
`

`

`
`
`Exhibit Description
`Translation of German Patent App. No. DE 195-46-692 A1 to Fig-
`ulla et al. (with a certification from Abraham I. Holczer attesting to
`the accuracy of the translation)
`Sections 31 and 32 of the German Patent Act in effect as of June 19,
`1997 through November 14, 2000
`Translation of Sections 31 and 32 of the German Patent Act in effect
`as of June 19, 1997 through November 14, 2000 (with a certification
`from Abraham I. Holczer attesting to the accuracy of the translation)
`Declaration of Thomas Vassiliades, Jr., M.D. with attached Exhibit
`1: Curriculum Vitae of Thomas Vassiliades, Jr., M.D.
`Declaration of Russell Hodge with attached Exhibit 1: Curriculum
`Vitae of Russell Hodge
`Declaration of Nicholas Mathews with attached Exhibit 1: Patent
`Owner’s Initial Infringement Contentions (also attached at Exh.
`1003)
`
`Exhibit No.
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`iv
`
`

`

`
`
`Inter partes review is respectfully requested for claims 16 and 19-24 of U.S.
`
`Patent No. 6,482,228 to Norred (“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, LLC
`
`(collectively “Petitioner”) are the real parties-in-interest. On or about April 9,
`
`2009, CoreValve, Inc. merged into Medtronic-CoreValve, Inc., which was subse-
`
`quently renamed Medtronic CoreValve, LLC, and is therefore not identified as a
`
`separate petitioner.
`
`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-
`
`ruary 6, 2013). In that matter, Petitioner’s motion to stay the district court proceed-
`
`ings pending inter partes review of the ‘228 Patent has been fully briefed and is
`
`currently before the court. In addition, the ‘228 Patent is the subject of IPR2014-
`
`00110 and IPR2014-00111, which were filed concurrently on October 31, 2013.
`
`C. Lead and Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`Petitioner provides the following designation of counsel:
`
`
`
`
`
`

`

`
`
`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 2800
`
`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-
`
`ment for any additional fees that might be due in connection with this Petition to be
`
`charged to the above-referenced Deposit Account.
`
`
`
`2
`
`

`

`
`
`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 anchored by a stent. ‘228 Patent, 1: 6-9; 2:63-3:13. Shown below is an an-
`
`notated version of Figure 4 showing the location of Replacement Aortic Valve 30
`
`and Stent 28 in a cut-away view of the ascending aorta.
`
`
`
`The ‘228 Patent discloses four replacement valve designs that can be an-
`
`chored with a stent: an umbrella valve 30 (Figs. 1-9); a conical valve 66 (Figs. 10-
`
`13); a trihedral valve 82 (Figs. 14-17); and biological tissue valves 100, such as
`
`cadaver or porcine (Figs. 18-19). The ’228 Patent explains what is well known in
`
`
`
`3
`
`

`

`
`
`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 Patent discloses that each of these replacement
`
`valve designs, when anchored by a stent, would be disposed against the aortic wall
`
`to reduce or eliminate peri-valvular leaks.
`
`With respect to claims 16 and 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
`
`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
`
`
`
`4
`
`

`

`
`
`biocompatible material, and are hingedly secured together with Ring 72, which is
`
`attached to Ring-Shaped Base 70. ‘228 Patent, 4:57-64. A “biocompatible, dura-
`
`ble, flexible generally conically-shaped fabric 75 membrane” is secured to the in-
`
`side surfaces of Fingers 68 and is used to interconnect Fingers 68. Id. The valve is
`
`anchored along the root of the aortic valve with Connecting Rods 80 which are
`
`connected to an aortic stent. ‘228 Patent, 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 Ring 86,
`
`which is attached to Base 88. ‘228 Patent, 5:33-62. Arms/Rods 84 are intercon-
`
`nected to each other by Membrane 92. Id. Each Arm/Rod 84 has a crescent-shaped
`
`pad 90 at its free end. Id. The trihedral 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.
`
`Membrane 75 prevents Fingers 68 from overextending to block coronary arteries
`
`
`
`5
`
`

`

`
`
`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.
`
`With respect to claims 20-24, the ‘228 Patent’s alleged invention is an aortic
`
`tissue valve. ‘228 Patent, 8:27-59. As shown in Figure 18 below, the tissue valve
`
`comprises a Cadaver/Porcine Valve 100 retained in a Base Ring 102 made of plia-
`
`ble biocompatible material with an outer circumference adapted to seat the Base
`
`Ring 102 about an aortic wall surrounding an aortic channel. ‘228 Patent, 6:1-8.
`
`The tissue valve is anchored along the root of the aortic valve with Connecting
`
`Rods 104. Id.
`
`
`
`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 November 14, 2000 (see
`
`Exh. 1002, paper 1). The ‘228 Patent does not claim priority to any earlier filed
`
`
`
`6
`
`

`

`
`
`applications. Although claims 16-24 (originally claims 19-27) were not addressed
`
`in the first Office Action mailed on August 9, 2001 (id., paper 3, “August 2001 Of-
`
`fice Action”), the Examiner stated in a January 30, 2002 personal interview (id.,
`
`paper 4) with applicant that “Claims 19-27 should have been stated as allowable in
`
`the 8/9/01 action.” In response to the August 2001 Office Action, applicant filed an
`
`amendment on February 26, 2002 (id., paper 5) that, among other things, ostensi-
`
`bly made non-substantive grammatical amendments to improve the language of
`
`claims 16-24. Id. at page 9 (“Applicant has also amended all the claims, including
`
`the allowed claims 19-27, to improve the language therein. No substantive changes
`
`have been made by these grammatical amendments.”) However, it should be noted
`
`that at least one of applicant’s amendments potentially broadened the scope of
`
`claim 20 (originally claim 23) beyond what was approved by the Examiner in that
`
`it deletes the “means for moving” language, as shown below:
`
`“23. (Amended) An aortic valve for controlling a blood flow through
`an aortic channel upon placement therein, said valve comprising:
`a tissue valve having an interior member [and circumference;] made
`of a tissue material and presenting an opening movable between open
`and closed positions;
`a ring member [secured to] surrounding said tissue valve, [along said
`tissue valve circumference and] said ring member having an outer cir-
`cumference adapted to seat said ring member about an aortic wall sur-
`rounding an aortic channel;
`
`
`
`7
`
`

`

`
`
`means for maintaining said ring member in said seated position about
`the aortic wall, [; and]
`[means for moving] said tissue valve interior member responsive to
`changes of conditions within the aorta for movement of said opening
`between a first closed position and a second open position.” (Id. at
`page 8).
`
`The Examiner subsequently issued a Notice of Allowability on April 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.
`
`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 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-
`
`
`
`8
`
`

`

`
`
`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 and 19-24 of the
`
`‘228 Patent 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 and 19-24 of the ‘228 Patent is requested.
`
`D. The Specific Art and Statutory Grounds on Which the Challenge
`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.
`
`Grounds
`
`1
`
`Claims 16 and 19-24 are anticipated under 35 U.S.C. §102(b) by US
`
`5,957,949 to Leonhardt et al. (“Leonhardt”)
`
`2
`
`Claims 16 and 19-24 are anticipated under 35 U.S.C. §102(b) by US
`
`5,411,552 to Andersen et al. (“Andersen”)
`
`3
`
`Claims 16 and 19-24 are anticipated under 35 U.S.C. §102(e) by US
`
`6,458,153 to Bailey (“Bailey”)
`
`
`
`9
`
`

`

`
`
`No.
`
`Grounds
`
`4
`
`Claims 16 and 19 are anticipated under 35 U.S.C. §102(b) by DE App. No.
`
`195 46 692 to Figulla (“Figulla”)
`
`5
`
`Claims 16 and 19 are under anticipated 35 U.S.C. §102(b) by US 5,855,597
`
`to Jayaraman (“Jayaraman”)
`
`6
`
`Claims 16 and 19 are under anticipated 35 U.S.C. §102(b) by US 3,657,744
`
`to Ersek (“Ersek”)
`
`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)
`
`A claim receives the “broadest reasonable construction in light of the speci-
`
`fication” in inter partes review. See 37 C.F.R. § 42.100(b). As described 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 and discloses four such replacement
`
`valve embodiments. In construing the challenged claims, Petitioner relies upon the
`
`implicit claim constructions within Patent Owner’s Initial Infringement Conten-
`
`tions (Exh. 1003), which were served as part of Patent Owner’s litigation against
`
`
`
`10
`
`

`

`
`
`Petitioner.1 There the Patent Owner contends that the claims of the ‘228 Patent
`
`cover a manufactured tissue valve sutured within a stent as shown in the following
`
`pictures.
`
`
`
`It must be noted, however, that in order to make such infringement claims,
`
`Patent Owner has stretched the meaning of the claim limitations beyond their
`
`broadest reasonable interpretation and ignored others altogether, particularly in the
`
`context of litigation. Although Petitioner disagrees with Patent Owner’s proposed
`
`1 The Initial Infringement Contentions (Ex. 1003) are also attached at Exhibit 1 to
`
`the Declaration of Nicholas Mathews (Exh. 1020), Petitioner’s counsel in Norred
`
`v. Medtronic, Inc., et al., Case No. 2:13-cv-02061 (D. Kan.). Figures from the
`
`Infringement Contentions are reproduced in the body of the Declaration of Rus-
`
`sell Hodge (Exh. 1019), Medtronic CoreValve’s Senior Program Director, for the
`
`purpose of identifying structures of Medtronic’s CoreValve that the Patent Own-
`
`er has labeled with limitations from the claims of the ‘228 Patent.
`
`
`
`11
`
`

`

`
`
`constructions, for the purposes of this inter partes review only, Petitioner accepts
`
`Patent Owner’s proposed constructions. The bottom line is this: if a tissue valve in
`
`a stent satisfies all the limitations of the claims of the ‘228 Patent as Patent Owner
`
`contends, then any one of the prior art references detailed below anticipate those
`
`same claims.
`
` “Membrane”
`
`1.
`The term “membrane” is used in claim 16. Patent Owner has construed the
`
`meaning of this term to not only refer to materials such as fabric or fibrous poly-
`
`mer, but also to include “tissue.” See Exh. 1003, p. 3; Exh. 1019, pp. 3-4. Although
`
`Petitioner disagrees with Patent Owner’s construction, that is the construction ap-
`
`plied to this term for purposes of this inter partes review. However, it should be
`
`noted that the ‘228 Patent draws a distinction between the terms “membrane” 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 of biological tissue in-
`
`corporated valves, such as cadaver/porcine valves.” ‘228 Patent, 5:64-65. Thus, the
`
`
`
`12
`
`

`

`
`
`term “membrane” in the ‘228 Patent should be more narrowly construed in the
`
`context of litigation to include fabric or fibrous polymer, but not tissue.
`
`“Means for mounting”
`
`2.
`Claim 16 recites a “means for mounting” limitation. The limitation begins, a
`
`“means for mounting said first open end of said membrane about said ring aperture
`
`with said second open end displaced therefrom.” The limitation continues, “said
`
`[mounting] means moving said membrane second end between a first open posi-
`
`tion to allow a blood flow therethrough and a second closed position to preclude a
`
`blood flow therethrough.” Thus, the claimed means performs a mounting function
`
`and a moving function. Patent Owner seems to have ignored the means plus func-
`
`tion strictures of the claim limitation and has instead broadly construed this limita-
`
`tion as being met by sutures for attaching the membrane to interior of a stent. See
`
`Exh. 1003, p. 4; Exh. 1019, pp. 4-5. It is presumed that Patent Owner intends for
`
`the sutures to be a structure that meets both the mounting and moving functions of
`
`the limitation, even though the sutures are stationary. Although Petitioner disagrees
`
`with Patent Owner’s construction, that is the construction applied to this limitation
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`for purposes of this inter partes review. It should be noted, however, that this limi-
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`tation should be more narrowly construed in the context of litigation under the
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`rules for construing a “means plus function” limitation under 35 U.S.C. § 112, ¶ 6.
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`
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`13
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`“Tissue Valve”
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`3.
`Petitioner submits that the phrase “tissue valve,” which appears in claims
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`20-23, is an “exogenous, biological tissue valve, such as cadaver and porcine tissue
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`valves.” This is a straightforward reading of the claim in the context of the specifi-
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`cation under the broadest reasonable interpretation standard as the sole reference to
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`“tissue” in the ‘228 Patent specification is “biological tissue incorporated valves,
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`such as cadaver/porcine valves.” ‘228 Patent, 5:64-65.
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`“Means for maintaining”
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`4.
`Claims 19 and 20 recite a “means for maintaining said ring member in said
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`seated position about the aortic wall.” Patent Owner seems to have ignored the
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`means plus function strictures of this claim and has instead broadly construed this
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`limitation to include a valve in a stent anchored to the aortic wall. See Exh. 1003,
`
`p. 6; Exh. 1019, p. 6-7. Although Petitioner disagrees with Patent Owner’s con-
`
`struction, that is the construction applied to this limitation for purposes of this inter
`
`partes review. It should be noted, however, that this limitation should be more nar-
`
`rowly construed in the context of litigation under the rules for construing a “means
`
`plus function” limitation under 35 U.S.C. § 112, ¶ 6.
`
`F. How the Construed Claims Are Unpatentable Under 37 C.F.R. §
`42.104(b)(4)
`
`An explanation of how construed claims 16 and 19-24 of the ‘228 Patent are
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`unpatentable under the statutory grounds identified above, including identification
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`
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`14
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`

`

`
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`of where each element of the claim is found in the prior art patents or printed pub-
`
`lications, is provided below in Section V and in claim charts A-1 to A-6.
`
`Supporting Evidence Under 37 C.F.R. § 42.104(b)(5)
`
`G.
`The exhibit numbers of the supporting evidence relied upon to support the
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`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-6.
`
`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 and 19-24 are Anticipated Under 35 U.S.C. §102(b) by
`US 5,957,949 to Leonhardt et al. (Exh. 1004)
`
`U.S. Patent No. 5,957,949 to Leonhardt et al. (“Leonhardt”) issued on Sep-
`
`tember 28, 1999 and thus qualifies as prior art under § 102(b). Although Leonhardt
`
`was considered during prosecution of the ‘228 Patent, in view of applicant’s post-
`
`allowance amendments and Patent Owner’s proposed claim constructions, Leon-
`
`hardt warrants reconsideration given that it describes an aortic heart valve prosthe-
`
`sis made of a biological tissue valve, such as porcine tissue valve, for use within a
`
`stent. The claim chart attached as Appendix A-1 details how each element recited
`
`in claims 16 and 19-24 is anticipated by Leonhardt.
`
`
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`15
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`

`
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`
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`Referring to annotated Figure 4 above, Leonhardt discloses a valve stent 20
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`for implantation in the aorta comprised of three elements: stent 26, biological
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`valve 22, and graft material 24. Leonhardt, 4:14-16. Graft material 24 is a thin-
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`walled biocompatible, flexible and expandable, low-porosity woven fabric (e.g.,
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`polyester or PTFE) that is attached to and encloses stent 26 to form a cylindrical
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`fluid passageway. Leonhardt, 3:33-45; 5:53-59. Stent 26 is a made of a nitinol
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`wire. Leonhardt, 4:66-67. The stent coerces graft material 24 to conform to the
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`tissue surface at the implant site. Leonhardt, 5:53-59. Leonhardt further discloses
`
`that the prosthesis may be completely sealed to the implant site tissue by light acti-
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`vated biocompatible tissue adhesive. Leonhardt, Abstract; 3:42-45; 4:63-65; 12:54-
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`57.
`
`Biological valve 22 is preferably a porcine valve that is attached within the
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`cylindrical fluid passageway formed by stent 26 and graft material 24 by sutures,
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`biocompatible adhesive, or a combination of the two. Leonhardt, 6:23-33. Leon-
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`
`
`16
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`

`

`
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`hardt further discloses that biological valve 22 opens and closes with pressure
`
`and/or flow changes to maintain bodily fluid flow in a single direction. Leonhardt,
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`1:11-14.
`
`As explained in the accompanying Vassiliades Declaration (Exh. 1018), it is
`
`readily apparent and inherent that the biological valve disclosed by Leonhardt
`
`moves between a closed position and an open position in response to pressure
`
`changes in the aorta. Natural heart valves utilize the pressure gradient created dur-
`
`ing systole and diastole to open and close the valve. A prosthetic heart valve,
`
`whether of a mechanical design or a tissue design as disclosed in Leonhardt, must
`
`necessarily function in the same manner as the natural heart valve it replaces. Thus,
`
`prosthetic valves, including the one disclosed in Leonhardt, must necessarily uti-
`
`lize the pressure gradient created during systole and diastole to open and close the
`
`prosthetic valve such that the blood flow controlling function of the natural valve is
`
`replaced.
`
`B. Claims 16 and 19-24 are Anticipated Under 35 U.S.C. §102(b) by
`US 5,411,552 to Andersen et al. (Exh. 1005)
`
`U.S. Patent No. 5,411,552 to Andersen et al. (“Andersen”) issued on May 2,
`
`1995 and thus qualifies as prior art under § 102(b). Although a patent related to
`
`Andersen (U.S. Patent No. 6,168,614) was considered during prosecution of the
`
`‘228 Patent, in view of applicant’s post-allowance amendments and Patent Own-
`
`er’s proposed claim constructions, Andersen warrants consideration given that it
`
`
`
`17
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`

`

`
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`describes an aortic heart valve prosthesis made of a biological tissue valve, such as
`
`porcine tissue valve, for use within a stent. The claim chart attached as Appendix
`
`A-2 details how each element recited in claims 16 and 19-24 is anticipated by An-
`
`dersen.
`
`
`
`Referring to annotated Figure 2 above, Andersen discloses valve prosthesis 9
`
`for implantation in the aorta comprising a stent made from an expandable cylinder-
`
`shaped thread structure and a biological (pig) cardiac valve 6 that is glued, welded
`
`or sutured within the stent. Andersen, Abstract; 2:35-37; 4:3-11; 5:11-14, 29-30,
`
`33-35; 7:3-12. Andersen further discloses that the stent abuts the inner wall of the
`
`aorta to ensure the securing of the valve prosthesis in the aorta. Andersen, Abstract;
`
`4:3-11; 5:9-28; 6:30-36; 7:3-12; Figs. 5-10.
`
`With regard to the function and purpose of the valve prosthesis, Andersen
`
`explains that the valve prosthesis ensures that the blood flows in one direction only
`
`and that it can be used to treat aorta insufficiency (i.e., leaking of the aortic valve
`
`
`
`18
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`

`

`
`
`that causes blood to flow in the reverse direction during ventricular diastole, from
`
`the aorta into the left ventricle). Andersen, 3: 17-19, 53-57.
`
`As explained in the accompanying Vassiliades Declaration (Exh. 1018), it is
`
`readily apparent and inherent that the biological valve disclosed by Andersen
`
`moves between a closed position and an open position in response to pressure
`
`changes in the aorta. Natural heart valves utilize the pressure gradient created dur-
`
`ing systole and diastole to open and close the valve. A prosthetic heart valve,
`
`whether of a mechanical design or a tissue design as disclosed in Andersen, must
`
`necessarily function in the same manner as the natural heart valve it replaces. Thus,
`
`prosthetic valves, including the one disclosed in Andersen, must necessarily utilize
`
`the pressure gradient created during systole and diastole to open and close the pros-
`
`thetic valve such that the blood flow controlling function of the natural valve is re-
`
`placed.
`
`C. Claims 16 and 19-24 are Anticipated Under 35 U.S.C. §102(e) by
`US 6,458,153 to Bailey (Exh. 1006)
`
`U.S. Patent No. 6,458,153 to Bailey et al. (“Bailey”) was filed on December
`
`31, 1999 and thus qualifies as prior art under § 102(e). Bailey was not cited during
`
`prosecution of the ‘228 Patent although it teaches a replacement aortic valve utiliz-
`
`ing a biological xenograft valve within a stent. The claim chart attached as Appen-
`
`dix A-3 details how each element recited in claims 16 and 19-24 is anticipated by
`
`Bailey.
`
`
`
`19
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`

`

`
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`
`
`Referring to annotated Figures 1 and 2 above, Bailey discloses a prosthetic
`
`cardiac valve comprising a stent support member 12, a graft member 11 which co-
`
`vers at least a portion the stent 12, and biological xenograft valve flaps/leaflets 28.
`
`Bailey, Abstract; 1:6-21; 1:28-38; 5:61-6:9; 7:58-8:19. Bailey further discloses that
`
`blood flow regulation is provided by the combination of the prosthetic valve flaps
`
`28 and the valve arms 24 moving between an open and closed position in response
`
`to blood pressure differentials acting upon the valve leaflets 26. Bailey, 6:10-14;
`
`9:25-47; 10:31-44. Graft member 11 can also be made of biologically-derived
`
`membranes and is coupled to lumenal surface of the stent 12 and is exverted such
`
`that the free