`
`
`
`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 IPR2014-00111
`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 ................................. 5 
`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) ....................................... 6 
`B.  Identification of Challenge Under 37 C.F.R. § 42.104(b) and Relief
`Requested ......................................................................................................... 6 
`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) ...................................................................... 7 
`E.  How the Challenged Claims Are to Be Construed Under 37 C.F.R. §
`42.104(b)(3) ..................................................................................................... 7 
`1.  “tissue” ........................................................................................................ 8 
`2.  “Means for maintaining” ............................................................................ 8 
`F.  How the Construed Claim(s) Are Unpatentable Under 37 C.F.R. §
`42.104(b)(4) ..................................................................................................... 9 
`G.  Supporting Evidence Under 37 C.F.R. § 42.104(b)(5) ................................... 9 
`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) ......................... 9 
`A.  Claims 20-24 are Anticipated Under 35 U.S.C. §102(a) by “A Foldable,
`Artificial Heart Valve,” March 3, 2000, Spiegel Online Article (Exhs. 1003
`& 1004) ............................................................................................................ 9 
`
`

`

`B.  Claims 20-24 are Anticipated Under 35 U.S.C. §102(b) by DE Patent
`Application No. 195 46 692 to Figulla (Exhs. 1005 & 1006) ....................... 11 
`C.  Claims 20-24 are Anticipated Under 35 U.S.C. §102(a) by DE Patent
`Application No. 198 57 887 A1 to Fraunhofer Corporation (Exhs. 1007 &
`1008) .............................................................................................................. 14 
`D.  Claims 20-24 are Anticipated Under 35 U.S.C. §102(e) by U.S. Patent No.
`6,454,799 to Schreck (Exh. 1009) ................................................................. 15 
`E.  Claims 20-24 are Anticipated Under 35 U.S.C. §102(e) by U.S. Patent No.
`6,425,916 to Garrison (Exh. 1010) ................................................................ 17 
`F.  Claims 20-24 are Anticipated Under 35 U.S.C. §102(b) by U.S. Patent No.
`3,657,744 to Ersek (Exh. 1011) ..................................................................... 18 
`G.  Claims 20-23 are Obvious Under 35 U.S.C. §103 Over Spiegel In View of
`Shu (Exhs. 1003, 1004 & 1012) .................................................................... 20 
`H.  Claims 20-23 are Obvious Under 35 U.S.C. §103 Over Figulla In View of
`Shu (Exhs. 1005, 1006 & 1012) .................................................................... 21 
`I.  Claims 20-23 are Obvious Under 35 U.S.C. §103 Over Fraunhofer In View
`of Shu (Exhs. 1007, 1008 & 1019) ................................................................ 22 
`J.  Claims 22 & 23 are Obvious Under 35 U.S.C. §103 Over Schreck In View
`of Shu (Exhs. 1009 & 1012) .......................................................................... 23 
`K.  Claims 20-23 are Obvious Under 35 U.S.C. §103 Over Garrison In View of
`Shu (Exhs. 1010 & 1012) .............................................................................. 24 
`L.  Claims 20-23 are Obvious Under 35 U.S.C. §103 Over Ersek In View of
`Shu (Exhs. 1011 & 1012) .............................................................................. 25 
`VI.  CONCLUSION .............................................................................................. 26 
`
`
`ii
`
`

`

`Exhibit List for Inter Partes Review of U.S. Patent No. 6,482,228
`
`Exhibit No.
`1001
`1002
`1003
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`1010
`1011
`1012
`1013
`
`Exhibit Description
`U.S. Patent No. 6,482,228 to Norred
`File History for U.S. Patent No. 6,482,228
`“A Foldable, Artificial Heart Valve” Spiegel Online Article
`Translation of “A Foldable, Artificial Heart Valve” Spiegel Online
`Article (with a certification from Abraham I. Holczer attesting to the
`accuracy of the translation)
`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)
`German Patent App. No. DE 198-57-887 A1 to Fraunhofer Corpora-
`tion
`Translation of German Patent App. No. DE 198-57-887 A1 to
`Fraunhofer Corporation (with a certification from Abraham I.
`Holczer attesting to the accuracy of the translation)
`U.S. Patent No. 6,454,799 to Schreck
`U.S. Patent No. 6,425,916 to Garrison et al.
`U.S. Patent No. 3,657,744 to Ersek
`U.S. Patent No. 6,139,575 to Shu et al.
`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. 1014].
`Exhibit 2: The complete prosecution history for patent DE 195-
`46-692 C1 [also attached at Exh. 1015].
`Exhibit 3: German Patent App. No. DE 195-46-692 as filed on
`December 14, 1995 [also attached at Exh. 1005, with certified
`English translation at Exh. 1006].
`Exhibit 4: German Patent App. No. DE 195-46-692 A1 as pub-
`lished on June 19, 1997 [also attached at Exh. 1016, with cer-
`
`iii
`
`

`

`Exhibit Description
`tified English translation at Exh. 1017].
`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. 1018, with certified English translation at Exh.
`1019].
`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.
`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.
`
`Exhibit No.
`
`1014
`1015
`1016
`1017
`
`1018
`
`1019
`
`1020
`
`iv
`
`

`

`Inter partes review is respectfully requested for claims 20-24 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 IPR2014-00110, 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
`
`

`

`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
`
`

`

`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 20 and its dependent claims 21-24, the
`
`‘228 Patent’s alleged invention is an exogenous, aortic tissue valve secured in a
`
`stent system (see annotated Figure 18 below) for controlling blood flow through an
`
`aortic channel. ‘228 Patent, 8:27-59. As shown in Figure 18 below, the tissue
`
`valve comprises a Cadaver/Porcine Valve 100 with an opening movable between
`
`open and closed positions, which is retained in a Base Ring 102 made of pliable
`
`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 tis-
`
`sue valve is anchored along the root of the aortic valve with Connecting Rods 104.
`
`Id.
`
`
`
`4
`
`

`

`
`
`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.
`
`
`
`5
`
`

`

`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 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 20-24 of the ‘228 Pa-
`
`tent be found unpatentable.
`
`
`
`6
`
`

`

`C. Claims for Which Inter Partes Review Is Requested Under 37
`CFR § 42.104(b)(1)
`
`Inter partes review of claims 20-24 of the ‘228 Patent is requested.
`
`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 and 103:
`
`No.
`1
`
`Grounds
`Claims 20-24 are anticipated by “A Foldable, Artificial Heart Valve,” March
`3, 2000, Spiegel Online Article (“Spiegel”)
`Claims 20-24 are anticipated by DE App. No. 195 46 692 (“Figulla”)
`2
`Claims 20-24 are anticipated by DE App. No. 198 57 887 A1 (“Fraunhofer”)
`3
`Claims 20-24 are anticipated by US 6,454,799 (“Schreck”)
`4
`Claims 20-24 are anticipated by US 6,425,916 (“Garrison”)
`5
`Claims 20-24 are anticipated by US 3,657,744 (“Ersek”)
`6
`Claims 20-23 are obvious over Spiegel in view of US 6,139,575 (“Shu”)
`7
`Claims 20-23 are obvious over Figulla in view of Shu
`8
`Claims 20-23 are obvious over Fraunhofer in view of Shu
`9
`10 Claims 22-23 are obvious over Schreck in view of Shu
`11 Claims 20-23 are obvious over Garrison in view of Shu
`12 Claims 20-23 are obvious over Ersek in view of Shu
`
`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-
`
`
`
`7
`
`

`

`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.
`
`“tissue”
`
`1.
`Petitioner submits that the term “tissue,” which appears in claims 20-23, is a
`
`“biological tissue, such as cadaver and porcine tissue.” This is a straightforward
`
`reading of the claim in the context of the specification under the broadest reasona-
`
`ble interpretation standard as the sole reference to “tissue” in the ‘228 Patent speci-
`
`fication is “biological tissue incorporated valves, such as cadaver/porcine valves.”
`
`‘228 Patent, 5:64-65.
`
`“Means for maintaining”
`
`2.
`Claim 20 recites a “means for maintaining said ring member in said seated
`
`position 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 corre-
`
`sponding to claim 20, the ‘228 Patent specification describes the means for per-
`
`forming the claimed function as follows: “Valve 100 is anchored along the root of
`
`the aortic valve with connecting rods 104.” ‘228 Patent, 6:4-5. Therefore, the ‘228
`
`Patent’s specification supports an interpretation of the “means” for performing the
`
`claimed function as “connecting rods” or an equivalent structure.
`
`
`
`
`
`8
`
`

`

`F. How the Construed Claim(s) Are Unpatentable Under 37 C.F.R. §
`42.104(b)(4)
`
`An explanation of how construed claims 20-24 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-7.
`
`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-7.
`
`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 20-24 are Anticipated Under 35 U.S.C. §102(a) by “A
`Foldable, Artificial Heart Valve,” March 3, 2000, Spiegel Online
`Article (Exhs. 1003 & 1004)
`
`As reflected at the upper left-hand corner of Exh. 1003, a German article ti-
`
`tled “A Foldable, Artificial Heart Valve,” under the classification of “Cardiology,”
`
`was published online by Spiegel Online (“Spiegel”) on March 3, 2000 at 17:07
`
`hours (i.e., 5:07 p.m.) and thus qualifies as prior art under § 102(a).2 The URL for
`
`2 See also MPEP 2128 (“An electronic publication, including an on-line database
`
`or Internet publication, is considered to be a “printed publication” within the
`
`
`
`9
`
`

`

`the
`
`article
`
`is
`
`http://www.spiegel.de/wissenschaft/mensch/kardiologie-
`
`zusammenfaltbare-kuenstliche-herzklappe-a-67568.html. Spiegel was not cited
`
`during prosecution of the ‘228 Patent although it describes an artificial aortic heart
`
`valve consisting of a pig heart valve and a stent system.
`
`
`
`The claim chart attached as Appendix A-1 details how each element recited
`
`in claims 20-24 is anticipated by Spiegel. As shown in the photograph of the proto-
`
`type device above, the pig heart valve is attached to wire ring at one end. This wire
`
`ring is also attached to several wire support structures through wire connecting
`
`rods.
`
`As explained in the accompanying Declaration of Thomas Vassiliades, Jr.,
`
`M.D. (Exh. 1020, “Vassiliades Declaration.”), it is readily apparent and inherent
`
`that the swine prosthetic heart valve disclosed by Spiegel – which Spiegel states
`
`“functioned perfectly” - moves between a closed position and an open position in
`
`
`meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to
`
`persons concerned with the art to which the document relates.”)
`
`
`
`10
`
`

`

`response to pressure changes in the aorta. Natural heart valves utilize the pressure
`
`gradient created during systole and diastole to open and close the valve. A pros-
`
`thetic heart valve, whether of a mechanical design or a tissue design as disclosed in
`
`Spiegel, must necessarily function in the same manner as the natural heart valve it
`
`replaces. Thus, prosthetic valves, including the one disclosed in Spiegel that “func-
`
`tioned perfectly,” must necessarily utilize 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 20-24 are Anticipated Under 35 U.S.C. §102(b) by DE Pa-
`tent Application No. 195 46 692 to Figulla (Exhs. 1005 & 1006)
`
`As explained in the accompanying Declaration of German Patent Attorney
`
`Felix Harbsmeier (Exh. 1013), German Patent Application No. 195 46 692 A1 to
`
`Figulla (Exhs. 1016 and 1017, “Figulla ‘692 Published Application”) was pub-
`
`lished on June 19, 1997, but was published with figures that do not match the spec-
`
`ification or the application as it was originally filed on December 14, 1995 (Exhs.
`
`1005 and 1006, “Figulla ‘692 Filed Application”). The Figulla ‘692 Published Ap-
`
`plication describes four figures numbered 1 through 4; however, it includes only
`
`two figures, neither one of which corresponds to any of the described figures. Any
`
`person reading Figulla ‘692 Published Application would notice that the two fig-
`
`ures included with the published application did not correspond to the four figures
`
`described in the specification of the published application. As such, Under Section
`
`
`
`11
`
`

`

`31 of the German Patent Act, any person noticing the incorrect published figures
`
`would have been able to inspect the file wrapper for the application that included
`
`Figulla ‘692 Filed Application and the four figures described in the specification of
`
`Figulla ‘692 Published Application. Thus, as of June 19, 1997, the Figulla ‘692
`
`Filed Application was readily available to any and all persons with an interest in
`
`heart valve prostheses. A fortiori, the Figulla ‘692 Filed Application constitutes a
`
`“printed publication” as of June 19. 1997 and, therefore, qualifies as prior art under
`
`§ 102(b). See Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1350
`
`(Fed. Cir. 2008) (a reference is publicly available if it was “disseminated or other-
`
`wise made available to the extent that persons interested and ordinarily skilled in
`
`the subject matter or art exercising reasonable diligence, can locate it.”).
`
`Figulla ‘692 Filed Application was not cited during prosecution of the ‘228
`
`Patent although it describes an aortic heart valve prosthesis made of tissue, such as
`
`porcine tissue, for use with a stent system. The claim chart attached as Appendix
`
`A-2 details how each element recited in claims 20-24 is met by Figulla ‘692 Filed
`
`Application. As shown below, Figure 2 of Figulla ‘692 Filed Application shows a
`
`“swine-heart valve” attached to “the proximal portion of the multi-component,
`
`self-expanding stent.” Figulla ‘692 Filed Application, p. 2, and Fig. 2 caption.
`
`
`
`12
`
`

`

`
`
`As explained in the accompanying Vassiliades Declaration (Exh. 1020), it is
`
`readily apparent and inherent that the swine prosthetic heart valve disclosed by the
`
`Figulla ‘692 Filed Application moves between a closed position and an open posi-
`
`tion in response to pressure changes in the aorta. Natural heart valves utilize the
`
`pressure gradient created during systole and diastole to open and close the valve. A
`
`prosthetic heart valve, whether of a mechanical design or a tissue design as dis-
`
`closed in the Figulla ‘692 Filed Application, must necessarily function in the same
`
`manner as the natural heart valve it replaces. Thus, prosthetic valves, including the
`
`one disclosed in the Figulla ‘692 Filed Application, 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.
`
`
`
`
`
`13
`
`

`

`C. Claims 20-24 are Anticipated Under 35 U.S.C. §102(a) by DE Pa-
`tent Application No. 198 57 887 A1 to Fraunhofer Corporation
`(Exhs. 1007 & 1008)
`
`German Patent Application No. 198 57 887 A1 to Fraunhofer Corporation
`
`(“Fraunhofer”) was published on July 6, 2000 and thus qualifies as prior art under
`
`§ 102(a). Fraunhofer was not cited during prosecution of the ‘228 Patent although
`
`it describes an aortic heart valve prosthesis made of biological tissue, such as por-
`
`cine tissue, for use with a stent system. The claim chart attached as Appendix A-3
`
`details how each element recited in claims 20-24 is anticipated by Fraunhofer.
`
`Referring to Figure 1 below, Fraunhofer discloses a multiple ring system
`
`where porcine tissue valve 2 is placed within “sealing and fastening ring 1” and is
`
`connected to “support rings 6” via “connecting pins 3.” Fraunhofer, p. 4:41-46.
`
`
`
`As explained in the accompanying Vassiliades Declaration (Exh. 1020), it is
`
`readily apparent and inherent that the swine (porcine) prosthetic heart valve dis-
`
`closed by Fraunhofer moves between a closed position and an open position in re-
`
`
`
`14
`
`

`

`sponse to pressure changes in the aorta. Natural heart valves utilize the pressure
`
`gradient created during systole and diastole to open and close the valve. A pros-
`
`thetic heart valve, whether of a mechanical design or a tissue design as disclosed in
`
`Fraunhofer, must necessarily function in the same manner as the natural heart
`
`valve it replaces. Thus, prosthetic valves, including the one disclosed in Fraunho-
`
`fer, must necessarily utilize the pressure gradient created during systole and diasto-
`
`le to open and close the prosthetic valve such that the blood flow controlling func-
`
`tion of the natural valve is replaced.
`
`D. Claims 20-24 are Anticipated Under 35 U.S.C. §102(e) by U.S. Pa-
`tent No. 6,454,799 to Schreck (Exh. 1009)
`
`U.S. Patent No. 6,454,799 to Schreck (“Schreck”) was filed on April 6, 2000
`
`and thus qualifies as prior art under § 102(e). Schreck was not cited during prose-
`
`cution of the ‘228 Patent although it teaches a replacement aortic valve utilizing
`
`porcine or bovine tissue in connection with a stent system. The claim chart at-
`
`tached as Appendix A-4 details how each element recited in claims 20-24 is antici-
`
`pated by Schreck. As shown in Figure 6, Schreck discloses an aortic heart valve
`
`comprising a tissue leaflet subassembly and a tissue-engaging base. Schreck, 8:64–
`
`65. Leaflet Subassembly 102 consists of an Elastic Wireform 106 that holds tissue
`
`leaflets 108 (e.g., bovine or porcine pericardium) and is wrapped with a Fabric
`
`Skirt 110. Schreck ,9:11-30. As shown in Figures 6 and 7 below, the Leaflet Sub-
`
`
`
`15
`
`

`

`assembly 102 is connected to a Tissue-Engaging Base 104 by Posts 146 and 148.
`
`Figure 7 shows the full assembled valve minus the Fabric Skirt 110.
`
`
`
`
`
`As explained in the accompanying Vassiliades Declaration (Exh. 1020), it is
`
`readily apparent and inherent that the tissue leaflets of the prosthetic heart valve
`
`disclosed by Schreck move between a closed position and an open position in re-
`
`sponse to pressure changes in the aorta. Natural heart valves utilize the pressure
`
`gradient created during systole and diastole to open and close the valve. A pros-
`
`thetic heart valve, whether of a mechanical design or a tissue design as disclosed in
`
`Schreck, must necessarily function in the same manner as the natural heart valve it
`
`replaces. Thus, prosthetic valves, including the one disclosed in Schreck, must
`
`necessarily utilize the pressure gradient created during systole and diastole to open
`
`
`
`16
`
`

`

`and close the prosthetic valve such that the blood flow controlling function of the
`
`natural valve is replaced.
`
`E. Claims 20-24 are Anticipated Under 35 U.S.C. §102(e) by U.S. Pa-
`tent No. 6,425,916 to Garrison (Exh. 1010)
`
`U.S. Patent No. 6,425,916 to Garrison (“Garrison”) was filed on February
`
`10, 1999 and thus qualifies as prior art under § 102(e). Garrison was not cited dur-
`
`ing prosecution of the ‘228 Patent although it teaches a replacement aortic valve
`
`utilizing porcine or bovine tissue in connection with a support structure. The claim
`
`chart attached as Appendix A-5 details how each element recited in claims 20-24 is
`
`anticipated by Garrison. Figure 38 shows one embodiment disclosed in Garrison
`
`where a tri-leaflet porcine valve is attached to a Circumferential Ring 111 that is in
`
`turn attached to a Valve Displacer 8D via Protrusions 34D. Garrison, 10:38-62.
`
`The Valve Displacer is expanded within the native valve to hold the native cardiac
`
`valve leaflets open and maintain the replacement valve in position.
`
`As explained in the accompanying Vassiliades Declaration (Exh. 1020), it is
`
`readily apparent and inherent that the leaflets of the swine (porcine) prosthetic
`
`heart valve disclosed by Garrison move between a closed position and an open po-
`
`sition in response to pressure changes in the aorta. Natural heart valves utilize the
`
`pressure gradient created during systole and diastole to open and close the valve. A
`
`prosthetic heart valve, whether of a mechanical design or a tissue design as dis-
`
`closed in Garrison, must necessarily function in the same manner as the natural
`
`
`
`17
`
`

`

`heart valve it replaces. Thus, prosthetic valves, including the one disclosed in Gar-
`
`rison, must necessarily utilize the pressure gradient created during systole and dias-
`
`tole to open and close the prosthetic valve such that the blood flow controlling
`
`function of the natural valve is replaced.
`
`
`F. Claims 20-24 are Anticipated Under 35 U.S.C. §102(b) by U.S. Pa-
`tent No. 3,657,744 to Ersek (Exh. 1011)
`
`U.S. Patent No. 3,657,744 to Ersek (“Ersek”) was published on April 25,
`
`1972 and thus qualifies as prior art under § 102(b). Ersek was not cited during
`
`prosecution of the ‘228 Patent although it discloses an aortic heart valve prosthesis
`
`made of a donor aorta secured to a wire mesh fixation sleeve. The claim chart at-
`
`tached as Appendix A-6 details how each element recited in claims 20-24 is antici-
`
`pated by Ersek.
`
`
`
`18
`
`

`

`
`
`
`
`Referring to Figure 4, Ersek discloses a tissue valve (i.e., transplant aortic
`
`heart valve) that is inserted in an upper expandable ring section 29 and secured to a
`
`bottom mesh ring 30 circumferentially. Ersek, Abstract, 3:1-6, 28-35, 50-55 and
`
`4:32-35. As shown in Figure 4, longitudinal wire struts 28 separate the two ex-
`
`pandable metal mesh ring sections 29 and 30. Ersek, 3:50-55.
`
`As explained in the accompanying Vassiliades Declaration (Exh. 1020), it is
`
`readily apparent and inherent that the tissue leaflets of the prosthetic heart valve
`
`disclosed by Ersek move between a closed position and an open position in re-
`
`sponse to pressure changes in the aorta. Natural heart valves utilize the pressure
`
`gradient created during systole and diastole to open and close the valve. A pros-
`
`thetic heart valve, whether of a mechanical design or a tissue design as dis