`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
`____________
`Cases IPR2014-00110
`IPR2014-00111
`IPR2014-00395
`Patent 6,482,228
`PETITIONER’S DEMONSTRATIVE
`EXHIBITS
`
`
`
`Overview of Instituted Grounds
`
` IPR2014-00110
` Claims 16-19 are anticipated by 6,440,164 to DiMatteo
` Claims 16-18 are anticipated by 4,030,142 to Wolfe
` IPR2014-00111
` Claims 20-24 are anticipated by.6,454,799 to Schreck
` Claims 22 and 23 are obvious over 6,454,799 to Schreck in view of 6,139,575 to Shu
` IPR2014-00395
` Claims 16 and 19-24 are anticipated by 5,957,949 to Leonhardt
` Claims 16 and 19-24 are anticipated by 6,458,153 to Bailey
`
`1
`
`
`
`Background on the ‘228 Patent
`
`2
`
`
`
`The ‘228 Patent is directed to a
`“Percutaneous Aortic Valve Replacement”
`
`3
`
`U.S. 6,482,228 (Ex. 1001), 1:6-9, Fig. 4
`
`
`
`The ‘228 Patent discloses four valve embodiments
`
`Umbrella Valve
`(4:5-52)
`
`Cadaver/Porcine
`Valve (5:63-6:8)
`
`Conical Valve
`(4:53-5:32)
`
`Trihedral Valve
`(5:33-62)
`
`4
`
`‘228 Patent, Figs. 6, 12, 16, & 18
`
`
`
`Claim Construction Issue:
`“ring member”
`(Independent claims 16 and 20)
`
`5
`
`
`
`“ring member” not limited to “pliable material”
`
`Patent Owner’s Proposed Construction:
`•
`“The term ‘ring member,’ as used in claims 16-19, means a ring made of
`a pliable, biocompatible material that seals against the aorta to reduce
`peri-valvular leaks.” ‘110, Paper 9 (Preliminary Response) at 14; see
`Paper 15 (Response) at 32-33. See also, ‘395, Paper 11 at 16-17;
`Paper 18 at 7-8.
`
`Board’s Construction in its Decision Instituting IPR2014-00110:
`•
`“Dr. Norred construes ‘ring member’ to mean a ring made of a pliable,
`biocompatible material that seals against the aorta to reduce perivalvular
`leaks. Id. … [W]e have no basis to conclude that the words of the claims
`should not be given their ordinary meaning. We therefore give those
`terms their ordinary meaning: a ring having a circumference that is part
`of a larger structure. We decline to require the ring to be made of any
`particular material.” ‘110, Paper 10 at 7-8.
`
`6
`
`See ‘110, Paper 25 (Reply) at 12-13; see also ‘395, Paper 22 15 1, 14; Hill Decl., ¶¶38-42
`
`
`
`Petitioner’s Expert (Alex Hill, PhD) agrees with Board
`
`“39. While Dr. Catchings’ declaration seems to state that the term ‘ring
`member’ as used in claims 16 and 20 means a ring made of ‘pliable’
`biocompatible material, I do not agree for several reasons.”
`
`“40. First, I do not find any express requirement of pliability in the claims, and I
`see nothing in the claims that would otherwise impose that requirement.”
`
`“41. Second, … while pliability could be a factor relating to a sealing function,
`heart valve seals are often created with relatively rigid ring structures. This can
`be easily achieved because the aorta itself is pliable and will conform to the
`shape of a relatively rigid heart valve ring member. In addition, besides
`pliability, several other factors relate to a sealing function with the aorta, such
`as the surface area of the ring and amount of contact with the aorta.”
`
`“42. Third, the term ‘pliable’ is a relative term, and it alone does not inform one
`of ordinary skill in the art as to its meaning. If anything, the addition of the term
`‘pliable’ makes the claim less understandable because the range of material
`hardness that can be used is vast.”
`
`7
`
`Hill Decl., ¶¶40-42; see ‘110, Paper 25 at 12, 14; ‘395, Paper 22 at 1, 14
`
`
`
`Claim Construction Issue:
`“means for mounting” and “moving” the membrane
`(Independent Claim 16)
`
`8
`
`
`
`Claim 16 recites
`a “means for mounting” and “moving” the membrane
`
`9
`
`‘228 Patent, 7:59-8:12 (8:7-12); see also ‘110, Paper 4 at 9-10, Paper 25 at 1-4, Paper 26 at 1-5; ‘395, Paper 6
`at 13, Paper 22 at 3-6, Paper 25 at 2-5
`
`
`
`“means for mounting” and “moving” the membrane
`in conical valve embodiment of Figs. 10-13
`
`“The fingers 68 … are hingedly secured together by ring 72 extending
`through the base 74 of each finger 68 and interconnected by … fabric 75
`membrane secured to the inside surfaces 69 of the fingers.” ‘228 Patent,
`4:56-61.
`“The fingers 68 extend generally radially inwardly and away from the
`base 70.” Id., 4:61-63.
`
`10
`
`‘228 Patent, Figs. 10-11, 4:53-5:14; see also ‘110, Paper 4 at 9-10, Paper 25 at 1-4, Paper 26 at 1-5; ‘395,
`Paper 6 at 13, Paper 22 at 3-6, Paper 25 at 2-5
`
`
`
`conical valve embodiment of Figs. 10-13
`Closed: “In the closed position (FIGS. 10-11), the tops 76 of the fingers contact
`each adjacent fingertip 76 to prevent regurgitation.” ‘228 Patent, 4:65-67.
`
`Open: During systole, “[f]ingers 68 pivot on ring 72 and tips 76 separate to allow
`blood to flow through the center of valve 66. …” Id., 5:9-14.
`
`11
`
`‘228 Patent, Figs. 10-13, 4:53-5:14; see also ‘110, Paper 4 at 9-10, Paper 25 at 1-4, Paper 26 at 1-5;
`‘395, Paper 6 at 13, Paper 22 at 3-6, Paper 25 at 2-5
`
`
`
`“means for mounting” and “moving” the membrane
`in trihedral valve embodiment of Figs. 14-17
`The “[a]rms 84 are hingedly attached to ring 86 of base 88 and extend
`upwardly and radially inwardly from base 88 to generally form a trihedron
`or cone.” ‘228 Patent, 5:35-39.
`
`“Each rod 84 has a crescent-shaped pad 90 at its free end.” Id., 5:39-40.
`
`“A cone-shaped membrane 92 … is secured to each arm 84 and base
`88.” Id., 5:40-42.
`
`12
`
`‘228 Patent, Figs. 14-15, 5:43-47; see also ‘110, Paper 4 at 9-10, Paper 25 at 1-4, Paper 26 at 1-5;
`‘395, Paper 6 at 13, Paper 22 at 3-6, Paper 25 at 2-5
`
`
`
`trihedral valve embodiment of Figs. 14-17
`Closed: “During diastole, back flow of blood from the aorta to the left ventricle
`causes valve 82 to close preventing regurgitation (FIGS. 14-15).” ‘228 Patent,
`5:43-45.
`
`Open: “During systole, blood is ejected from the left ventricle to force valve 82
`open and allow blood to flow into the ascending aorta through the center of valve
`82.” Id., 5:45-47.
`
`13
`
`‘228 Patent, Figs. 14-17, 5:43-47; see also ‘110, Paper 4 at 9-10, Paper 25 at 1-4, Paper 26 at 1-5;
`‘395, Paper 6 at 13, Paper 22 at 3-6, Paper 25 at 2-5
`
`
`
`Petitioner’s Construction of
`“Means for Mounting” and “Moving” the Membrane
`
` “fingers or arms hingedly attached or hingedly secured to the ring
`member and a free end spaced therefrom” and equivalents.
`
` Consistent with conical valve embodiment disclosure of fingers 68 having
`a first end hingedly secured to the ring 72 and a free second end spaced
`therefrom. ‘228 Patent, 4:54-5:14.
`
` Consistent with trihedral valve embodiment disclosure of arms 84 having
`a first end hingedly attached to the ring 86 and a free second end spaced
`therefrom. Id., 5:33-47.
`
` Consistent with claim 17 which states the “mounting means comprises at
`least one arm having a first end hingedly secured to said ring member
`and a free second spaced therefrom.” Id., 8:13-20.
`
`14
`
`‘228 Patent; see also ‘110, Paper 4 at 9-10, Paper 25 at 1-4, Paper 26 at 1-5;
`‘395, Paper 6 at 13, Paper 22 at 3-6, Paper 25 at 2-5
`
`
`
`Under Beckson Marine,
`the “means for mounting” and “moving” the membrane
`should not be construed using only functional language
`
`
`
`
`
`
`
`
`
`
`
`15
`
`In its Decision to Institute Trial, the Board adopted, as “reasonable at this stage of the
`proceeding,” a construction of the “means for mounting” and “moving” the membrane in
`terms of the membrane being “hingedly secured” or “hingedly attached” about the ring
`aperture. ‘110, Paper 10 at 10.
`That construction is incomplete under Beckson Marine because while it expresses a
`function (“hingedly secured” or “hingedly attached”), it lacks any structure for performing
`the function. Beckson Marine, Inc. v. NFM, Inc., 144 Fed. Appx. 862 (Fed. Cir. 2005).
`The Federal Circuit held that “means hingedly connecting said window pane to said
`mounting flange” must be interpreted under §112, ¶6 because “[t]he language ‘hingedly
`connecting’ recites a function, not a particular defined structure.” Id. at 864-865.
`The phrase “does not recite limited and definable structure performing the function of
`‘hingedly connecting.’” Id. at 866.
`“In light of this disclosure, the district court properly construed the limitation ‘means
`hingedly connecting’ to require ‘a windowpane connected to a mounting flange using
`hinge lugs pivotally secured to cooperable lugs b[y] means of a hinge pin, thus allowing
`the window to open and shut by pivoting about a hinge,” and equivalents. Id.
`
`See ‘110, Paper 25 at 1-4, Paper 26 at 1-5; ‘395, Paper 22 at 3-6, Paper 25 at 2-5
`
`
`
`Independent Claim 16 Does Not Cover the
`Umbrella Valve Embodiment of Figs. 6-9
`• Claim 16 recites: a “ring member…including an aperture for blood flow
`therethrough”
`
`•
`
`In the embodiment of Figs. 6-9 (umbrella valve) the blood flows
`“around valve 30” and not through a “ring including an aperture for
`blood flow therethrough.”
`
`16
`
`‘228 Patent, Fig. 6; 4:28-36; see ‘110, Paper 25 at 3, Paper 26 at 1-2; ‘395, Paper 22 at 5, Paper 25 at 2-3
`
`
`
`Independent Claim 16 Does Not Cover the
`Tissue Valve Embodiment of Figs. 18-19
`• Claim 16 recites that the “membrane” has a “first open end … and
`a second open end displaced therefrom”
`
`• The embodiment of Figs. 18-19 (tissue valve) does not show a
`“first open end … and a second open end displaced therefrom”
`
`Entire Description of Tissue Valve Embodiment
`
`17
`
`‘228 Patent, Fig. 18; 5:63 -6:8; see ‘110, Paper 25 at 3, Paper 26 at 1-2; ‘395, Paper 22 at 5, Paper 25 at 2-3
`
`
`
`Claim Construction Issue:
`“means for maintaining”
`(Independent Claim 20, and
`Dependent Claim 19)
`
`18
`
`
`
`Claims 19 and 20 recite a
`“means for maintaining said ring member in
`said [“seated position” or “seat”] about the aortic wall”
`
`19
`
`‘228 Patent, Claims 19-20; see ‘111, Paper 25 at 2-5, Paper 26 at 2-3; ‘395, Paper 22 at 8-10, Paper 25 at 5-6
`
`
`
`The ‘228 Patent discloses two types of “rods”
`
`Rods that are part of the stent system 28
`
`Connecting Rods 104 that are part of the valve 100
`
`20
`
`‘228 Patent, 2:61-63, 6:4-6; see ‘111, Paper 10 at 6-9, Paper 25 at 2-5, Paper 26 at 2-3;
`‘395, Paper 22 at 8-10, Paper 25 at 5-6
`
`
`
`Board’s Construction in its
`Decision Instituting IPR2014-00111
`“Patent Owner asserts that the ‘means for maintaining’ is the stent system 28 or an
`equivalent structure. Prelim. Resp. 16 [citations omitted].” ‘111, Paper 10 at 6.
`
`“Two types of ‘rods’ are disclosed: rods that are part of the stent; and rods that are
`part of the valve. The stent system 28 is made up of a small slotted stainless steel
`tube or series of interconnected rods, which form an expandable cylindrical lattice or
`scaffolding. Ex, 1001, col. 2, ll. 61-63. There also are rods that are part of the valve.”
`In the context of the embodiment disclosed in Figures 18 and 19, the Specification
`states that valve 100 (not ring 102) is anchored with rods 104 connected to stents
`28. Id. at col. 6, ll. 4-6; [other citations omitted].” ‘111, Paper 10 at 8.
`
`“Thus, based on the Specification, in the context of the tissue valve disclosed in
`Figures 18 and 19, it is the combination of rods 104 interacting with stent 28 that
`anchor valve 100 and seat ring member 102. In that regard, it is rods 104 interacting
`with stent 28 that are the structure corresponding to the ‘means for maintaining’
`called for in claim 20. This corresponding structure, and equivalents thereof, is the
`broadest reasonable construction of the ‘means for maintaining’ the ring member in
`seated position at this stage of the proceeding, and we therefore adopt it for
`purposes of this Decision.” ‘111, Paper 10 at 9.
`21
`
`‘111, Paper 10 at 6-9; see also, ‘111, Paper 25 at 2-5, Paper 26 at 2-3; ‘395, Paper 22 at 8-10, Paper 25 at 5-6
`
`
`
`Conception
`Independent Claims 16 and 20
`“Ring Member”
`
`22
`
`
`
`Norred’s December 21, 1998 sketch
`
`23
`
`Ex. 2003 (‘110), Ex. 2103 (‘111), Ex. 2203 (‘395)
`
`
`
`Norred does not explain how reference in the sketch to “one
`example sutured bioprosthetic valve” at the same location as the
`native “aortic valve” meets the “ring member” element
`
`Original Sketch
`
`24
`
`‘110, Paper 15 at 9; Norred Decl., ¶7 (claim 16); see also ‘111, Paper 15 at 11; Norred Decl., ¶7 (claim 20); see
`also ‘395, Paper 18 at 15
`
`
`
`Figulla’s Fig. 4 shows deployment of an aortal
`bioprosthesis or artificial aortal valve with a self-
`expanding stent
`
`25
`
`‘110, Ex. 1013, Fig. 4. See also, ‘110, Paper 25 at 5-6; ‘111, Paper 25 at 4; ‘395, Paper 22 at 9
`
`
`
`Norred stated that Fig. 4 of Figulla “does not have a
`membrane outside of that stent system like a ring member”
`
`26
`
`Norred. Dep. Tr., 89:6-13 (discussing Fig. 4 of Figulla). See also, ‘110, Paper 25 at 5-6; ‘111, Paper 25 at 4; ‘395,
`Paper 22 at 9
`
`
`
`How can Norred’s sketch disclose a “ring member”
`as claimed if Fig. 4 of Figulla does not?
`
`27
`
`See ‘110, Norred Decl., ¶7; Paper 15 at 8; Norred. Dep. Tr., 88:23-89:13; Ex. 1013, Fig. 4
`See also ‘111, Paper 15 at 7-12 (11), Paper 25 at 4; ‘395, Paper 18 at 12-20 (15), Paper 22 at 9
`
`
`
`Conception
`Independent Claim 16
`“a membrane having first and second
`spaced-apart open ends”
`
`28
`
`
`
`Norred does not explain how pointing to the upper end of the aorta
`illustrates a “second spaced-apart open end[s]” of a membrane (1)
`“displaced” from a “first open end” of the membrane, (2) that is moved
`“between a first open position to allow a blood flow therethrough and a
`second closed position to preclude a blood flow therethrough.” (Cl. 16)
`
`29
`
`‘110, Paper 15 at 10; Norred Decl., ¶7; ‘395, Paper 18 at 16
`See also ‘110, Paper 25 at 6, ‘395 Paper 22 at 7-8
`
`
`
`Conception
`Independent Claim 16
`“means for mounting… [and] moving”
`
`30
`
`
`
`“means for mounting” and “moving”: Sketch does not
`disclose the “sutured bioprosthetic valve” being “hingedly
`secured” or “hingedly attached” to a ring member
`
`31
`
`‘110, Paper 15 at 11; Norred Decl., ¶7; ‘395, Paper 18 at 17
`See also ‘110, Paper 25 at 6; ‘395 Paper 22 at 8
`
`
`
`“means for mounting” and “moving”: Sketch does not
`disclose “fingers or arms hingedly attached or hingedly
`secured” to a ring member
`
`32
`
`‘110, Paper 15 at 11; Norred Decl., ¶7; ‘395, Paper 18 at 17
`See also ‘110, Paper 25 at 6; ‘395 Paper 22 at 8
`
`
`
`Conception
`Independent Claim 20, and
`Dependent Claim 19
`“means for maintaining”
`
`33
`
`
`
`“means for maintaining”: Norred points to central portion of
`“nitinol self-expanding stent” and not to rods of valve
`interconnecting with stent per Board’s Claim Construction (see
`slide 21)
`
`34
`
`‘110, Paper 15 at 12, Norred Decl., ¶7; ‘395 Paper 18 at 18 (Red Box Added) (claim 19)
`See also ‘111, Paper 15 at 11, Paper 25 at 2-5, Norred Decl., ¶7 (claim 20); ‘395, Paper 22 at 8-10
`
`
`
`Diligence by Norred
`
`35
`
`
`
`Relevant Dates
`
`Dec. 21, 1998: Norred’s claimed conception date
` Oct. 21, 1999: DiMatteo’s effective date
` Dec. 31, 1999: Bailey’s effective date
` Apr. 6, 2000: Schreck’s effective date
`Nov. 14, 2000: ‘228 Patent filing date (constructive reduction
`to practice)
`
`36
`
`See ‘110, Paper 25 at 4-12; ‘111, Paper 25 at 1-10; ‘395 Paper 22 at 6-14; DiMatteo, Ex. 1003 (‘110);
`Bailey, Ex. 1006 (‘395); Schreck, Ex. 1009 (‘111)
`
`
`
`
`
`
`
`Burden to Show Diligence
`Reasonable Diligence for Entire Critical Period:
` A party must demonstrate reasonable diligence toward reduction to practice from
`date just prior to the other party’s invention date. Mahurkar v. C.R. Bard, Inc., 79
`F.3d 1572, 1578 (Fed. Cir. 1996)
`“[A] party alleging diligence must account for the entire critical period.” Id. at 6-7.
`Iron Dome LLC v. E-Watch, Inc., IPR2014-00439, Paper 16 at 6 (Aug. 4, 2014).
`“Even a short period of unexplained inactivity is sufficient to defeat a claim of
`diligence.” Id. at 7 (examples of lack of reasonable diligence found based on
`insufficient activity for 2-day and 13-day period).
`Specific as to Facts & Dates:
`“[A] party alleging diligence must provide corroboration with evidence that is
`
`specific both as to facts and dates.” Id.
`“Merely stating that there were no weeks or months that he ‘did not work on the
`laser’ is not enough, absent supporting facts showing specifically what that ‘work’
`consisted of and when it was performed.” Gould v. Schawlow, 363 F.2d 908, 918
`(C.C.P.A. 1966).
`
`
`
`37
`
`See ‘110, Paper 25 at 4-12; ‘111, Paper 25 at 1-10; ‘395 Paper 22 at 6-14
`
`
`
`Norred does not identify specific dates for work
`done with Dr. Hsieh
`
`38
`
`Norred Decl., ¶¶37 & 40
`See ‘110, Paper 25 at 7-12 (8-9); ‘111, Paper 25 at 6-10 (7-8); ‘395, Paper 22 at 10-14 (10-11)
`
`
`
`Norred does not identify specific dates for work
`done with Dr. Lombardo
`
`39
`
`Norred Decl., ¶42
`See ‘110, Paper 25 at 7-12 (8-9); ‘111, Paper 25 at 6-10 (7-8); ‘395, Paper 22 at 10-14 (10-11)
`
`
`
`Dr. Lombardo’s testimony does not provide specific
`dates for work done for Norred
`
`40
`
`Lombardo Decl., ¶6-7
`See ‘110, Paper 25 at 7-12 (8-9); ‘111, Paper 25 at 6-10 (7-8); ‘395, Paper 22 at 10-14 (10-11)
`
`
`
`Norred does not identify specific dates he worked
`on his “fellowship project” related to his invention
`
`41
`
`Norred Decl., ¶¶45-47
`See ‘110, Paper 25 at 7-12 (9); ‘111, Paper 25 at 6-10 (6-7); ‘395, Paper 22 at 10-14 (11-12)
`
`
`
`Diligence by Patent Attorney, James Kernell
`
`42
`
`
`
`To prove diligence, attorney's records should show exact
`days when activity specific to patentee's application
`occurred
`
` In re Enhanced Sec. Research, LLC, 739 F.3d 1347, 1358-59 (Fed.
`Cir. 2014) (quoting Bey, 806 F.2d at 1028) (Federal Circuit “emphasized
`that the attorney's records should ‘show the exact days when activity specific
`to [the patentee's] application occurred.’ [citation omitted].”)
`
`43
`
`See ‘110, Paper 25 at 7-12 (10); ‘111, Paper 25 at 6-10 (8-9); ‘395, Paper 22 at 10-14 (12-13)
`
`
`
`According to Mr. Kernell, the ‘228 Application took
`approximately 80 hours to prepare spread out over six
`months from May 3, 2000 to Nov. 14, 2000
`
`“3. …[T]he application for the ‘228 patent took approximately 80 hours to
`prepare.”
`
`“5. On May 11, 2000, I received a retainer check from Dr. Norred and
`formal authorization to begin preparing the patent application.”
`
`“13. During the weeks of June 12 and 19, 2000, … I began preparing the
`Norred application.”
`
`“32. On November 14, 2000, I filed the patent application for Dr. Norred’s
`U.S. patent, Patent No. 6,482,228.”
`
`44
`
`Kernell Decl., ¶¶ 3, 5, 13, 32
`See ‘110, Paper 25 at 10-12; ‘111, Paper 25 at 8-10; ‘395, Paper 22 at 12-14
`
`
`
`Mr. Kernell has no records to show exactly when he
`worked on the ‘228 application, or any other application
`during, this 6-month period
`
`45
`
`Kernell Tr., 17:25-18:1, 40:16-21
`See ‘110, Paper 25 at 10-12; ‘111, Paper 25 at 8-10; ‘395, Paper 22 at 12-14
`
`
`
`To prove diligence, attorney's records should show patent
`application at issue and unrelated cases are taken up in
`chronological order
`
` Bey v. Kollonitsch, 806 F.2d 1024, 1027-28 (Fed. Cir. 1986) (quoting,
`Rines v. Morgan, 250 F.2d 365, 369 (C.C.P.A. 1957)).
` “[I]f the attorney has a reasonable backlog of work which he takes up in
`chronological order and carries out expeditiously, that is sufficient.” Id. at
`1028.
` However, “[g]enerally, the patent attorney must show that unrelated cases
`are taken up in chronological order, thus, the attorney has the burden of
`keeping good records of the dates when cases are docketed as well as
`the dates when specific work is done on the applications.” Id.
`
`46
`
`See ‘110, Paper 25 at 10-12; ‘111, Paper 25 at 8-10; ‘395, Paper 22 at 12-14
`
`
`
`Mr. Kernell does not know when other matters that he
`worked on during this 6 month period came into his firm
`
`47
`
`Kernell Tr., 48:1-19
`See ‘110, Paper 25 at 10-12; ‘111, Paper 25 at 8-10; ‘395, Paper 22 at 12-14
`
`
`
`Mr. Kernell has no records to show he took up other
`matters in chronological order during this 6-month period
`
`48
`
`Kernell Tr., 48:19-49:2, 51:20-22
`See ‘110, Paper 25 at 10-12; ‘111, Paper 25 at 8-10; ‘395, Paper 22 at 12-14
`
`
`
`Mr. Kernell’s handling of the ‘228 Application over a 6-
`month period was inconsistent with his typical practice
`
`49
`
`Kernell Tr., 47:11-25
`See ‘110, Paper 25 at 10-12; ‘111, Paper 25 at 8-10; ‘395, Paper 22 at 12-14
`
`
`
`Mr. Kernell’s handling of the ‘228 Application was
`inconsistent with his typical practice (con’t)
`
`50
`
`Kernell Tr., 51:5-22
`See ‘110, Paper 25 at 10-12; ‘111, Paper 25 at 8-10; ‘395, Paper 22 at 12-14
`
`
`
`Mr. Kernell’s handling of the ‘228 Application was
`inconsistent with his typical practice (con’t)
`
`51
`
`Kernell Tr., 51:23-52:9
`See ‘110, Paper 25 at 10-12; ‘111, Paper 25 at 8-10; ‘395, Paper 22 at 12-14
`
`
`
`Patentability/Unpatentability Over Prior Art
`
`52
`
`
`
`Petitioner’s Response to Norred’s Argument that the Prior
`Art References Fail to Disclose a Pliable “Ring Member”
`
` Norred argues that DiMatteo, Wolfe, Leonhardt, and Bailey all fail to
`disclose pliable “ring members.”
` DiMatteo: Norred argues that “the liner 82/trellis 24 combination —
`is not and cannot be pliable.” ‘110, Response to Petition, Paper 15
`at 35.
` Wolfe: With respect to valve seat assembly 14 and annular ring 56,
`Norred argues that “neither of these ring members is pliable” and
`“these ring members are not pliable.” Id. at 38.
` Leonhardt: Norred argues that “the liner 82/trellis 24 combination
`[structures not disclosed in Leonhardt] — is not and cannot be
`pliable.” ‘395, Response, Paper 18 at 8.
` Bailey: Norred argues that “Stent 12 is not and cannot be pliable.”
`Id. at 34.
`
`53
`
`See ‘110, Paper 25 at 12-14; ‘395, Paper 22 at 1, 14.
`
`
`
`A “Ring Member” Need Not Be Pliable
`
` The Board previously rejected Norred’s argument that “ring member”
`should be construed to mean “a ring made of a pliable, biocompatible
`material.” ‘110, Decision, Paper 10 at 7-8; see ‘395, Decision, Paper
`13 at 7.
` The Board “decline[d] to require the ring to be made of any particular
`material.” Id.
` The Board “therefore [gave] those terms their ordinary meaning: a ring
`having a circumference that is part of a larger structure.” Id.
` Petitioner’s expert (Alex Hill, PhD) agrees that a ring member need not
`be pliable. (“[W]hile pliability could be a factor relating to a sealing
`function, heart valve seals are often created with relatively rigid ring
`structures. This can be easily achieved because the aorta itself is
`pliable and will conform to the shape of a relatively rigid heart valve
`ring member.”) Hill Decl, ¶41 (see Slide 7).
`
`54
`
`See also, ‘110, Paper 25 at 12-14; ‘395, Paper 22 at 1, 14.
`
`
`
`The “Ring Members” of DiMatteo, Leonhardt, and Bailey
`are Pliable
`
` Norred’s expert, Dr. Catchings, testified that “super elastic material
`is pliable.” Catchings Tr.,195:8-10.
` DiMatteo, Leonhardt, and Bailey all disclose “ring members” made
`with “super elastic materials”:
` DiMatteo discloses that “[s]haped memory alloys having
`superelastic properties…are among the preferred trellis [24]
`materials.” ‘110, Ex. 1003, 8:60-67, 15:66-16:2.
` Leonhardt ‘s stent 26 is formed of “super elastic wire.” ‘395, Ex.
`1004, 3:48-56, 4:27-29, 4:63-5:2.
` Bailey’s stent 12 is “made from shape memory or super-elastic
`materials.” ‘395, Ex. 1006, 1:28-38; 5:34-43, 61-6:9; 7:58-8:19,
`33-37.
`
`55
`
`See also, ‘110, Paper 25 at 12-14; ’395, Paper 22 at 1, 14.
`
`
`
`Wolfe Also Discloses a Pliable Ring Member
`
`Wolfe discloses that “valve seat
`assembly 14 includes a soft seating
`ring 16….” ‘110, Ex. 1006, 3:51-53).
`
`Wolfe further discloses that “fixation
`cover 20, which is a Dacron mesh
`cloth or other suitable material.” Id.,
`3:61-64.
`
`‘110, Ex. 1006, Fig. 2B.
`
`56
`
`See ‘110, Paper 4 at Appendix-13, Paper 25 at 14
`
`
`
`Petitioner’s Response to Norred’s Argument that the
`“means for maintaining” in the Prior Art Does Not Extend
`into the “Ascending Aorta”
`
`Norred argues that Schreck and Leonhardt fail to disclose a
`“means for maintaining” that extends into the “ascending aorta”:
` Schreck: Norred argues that “[t]ubular member 140 does not
`extend into the ascending aorta.” ‘111, Response, Paper 15 at
`26; ‘111, Pet. Reply, Paper 25 at 11-12.
` Leonhardt: Norred argues that “[t] he stent disclosed in
`Leonhardt … cannot extend into the ascending aorta without
`blocking the coronary artery.” ‘395, Response, Paper 18 at 10-
`11; ‘395, Pet. Reply, Paper 22 at 1-2.
`
`57
`
`
`
`Claims 19 and 20 Do Not Have Any Limitations Regarding
`the location of the “means for maintaining”
`Claims 19 and 20:
`• have no limitations re (1) location of “means for maintaining” or (2) “ascending aorta”.
`•
`require only that ring member (not means for maintaining) be adapted to seat about an
`aortic wall (not the “ascending aorta”):
`
`16. … a ring member having a
`circumference adapted to seat about an
`aortic wall surrounding an aortic channel, ….
`19. The aortic valve as claimed in claim 16
`further comprising means for maintaining
`said ring member in said seat about the
`aortic wall.
`
`20. … ring member having an outer
`circumference adapted to seat said ring
`member about an aortic wall surrounding an
`aortic channel;
`means for maintaining said ring member in
`said seated position about the aortic wall, …
`
`The Board: “Dr. Norred’s contention rests upon the presumption that the ‘means for
`maintaining’ imposes specific requirements on the location at which a valve is positioned
`within the aorta. We disagree because the ‘means for maintaining’ refers to specific
`structures of the claimed aortic valve that maintain the ring member seated ‘about the aortic
`wall,’ rather than a specific location within the aorta relative to coronary arteries.” ‘395,
`Decision, Paper 13 at 15.
`
`58
`
`See ‘111, Paper 25 at 11-12; ‘395, Paper 22 at 1-2.
`
`
`
`The “ring member” in Schreck is Seated Against the
`Aortic Wall
`
`The Board found “that skirt 110 is the outer
`circumference of Schreck’s ring member
`because it is skirt 110 that seats against the
`aortic wall.” ‘111, Decision, Paper 10 at 13.
`
`59
`
`See ‘111, Paper 10 at 14-15; Paper 25 at 11-13
`
`
`
`Leonhardt’s Valve Stent is in the Ascending Aorta
`
`In Leonhardt, the valve stent
`is in the “ascending aorta”
`because Leonhardt
`discloses the “valve stent
`fully deployed within the
`aorta above the aortic
`valve.”
`Ex. 1004, 3:59-60, Fig. 3;
`see ‘395, Paper 22 at 1-2.
`
`Ex. 1019, Page 2, Fig. 1; Hill Decl., ‘111, Ex. 1026, ¶33.
`
`60
`
`
`
`Petitioner’s Response to Norred’s Argument that there
`are Problems with Prior Art Designs
`
`Example: Norred’s Arguments Regarding Schreck:
`
` Norred argues that the high pressures within the aorta will
`cause posts 146 and 148 of the Schreck valve to cantilever and
`that “[t]his will pull the tissue-engaging base 104 and fabric skirt
`110 away from the aortic wall, causing misalignment of the
`leaflets 32, perivalvular leaks, and ultimately dislodgment and
`failure of the device.” ‘111, Response to Petition, Paper 15 at
`26; see ‘111, Pet. Reply, Paper 25 at 13-14.
`
`61
`
`
`
`
`
`Petitioner’s Expert Testimony Regarding Schreck
`“Dr. Catchings’ declaration seems to indicate that the Schreck valve does not
`
`extend into the aorta. This is incorrect.” Hill Decl., ¶66.
`“Dr. Catchings’ testimony also seems to indicate that not a large portion of the
`valve goes supravalvular (meaning above the valve, i.e., into the ascending
`aorta), and as a result the device would undergo substantial stress. I disagree,
`as many heart valves used in practice today do not extend deeply into the
`ascending aorta have been found to work perfectly well.” Id. at ¶67.
`“Dr. Catchings’ deposition testimony speaks about the cantilevering effect of
`the posts 146/148 and has the belief that such effect will cause regurgitation. I
`disagree.” Id. at ¶69.
`“Dr. Catchings’ deposition testimony further presents various hypothetical
`drawings … of the Schreck valve, and also presents testimony of what ‘could
`happen’ with various manners of implantation. None of this testimony or
`drawings find a basis or foundation in Schreck. I find nothing credible about this
`testimony, as one of ordinary skill in the art would not design or implant the
`Schreck valve in the manner suggested or hypothesized by Dr. Catchings’
`testimony.” Id. at ¶70.
`
`
`
`
`
`62
`
`See ‘111, Paper 25 at 13-14; ‘395, Paper 22 at 2-3, 15
`
`
`
`
`
`Petitioner’s Expert Testimony Regarding DiMatteo
`“Dr. Catchings’ declaration refers to tissue ingrowth in DiMatteo as somehow
`
`being required for the valve therein to seal. There is no such teaching or
`disclosure in DiMatteo. … .” Hill Decl., ¶57.
`“Dr. Catchings’ declaration also states that the pressures and blood flow in the
`aorta are too great for tissue growth to occur. This is incorrect. In fact, tissue
`ingrowth almost always occurs in the aorta with any device or foreign object
`that is in contact with the aorta. This is the natural response of the human
`anatomy and physiology of the body.” Hill Decl., ¶58.
`“Dr. Catchings’ deposition testimony further presents various hypothetical
`drawings … of the DiMatteo valve, and also presents testimony of what ‘could
`happen’ with various manners of implantation. None of this testimony or
`drawings find a basis or foundation in DiMatteo. I find nothing credible about
`this testimony, as one of ordinary skill in the art would not design or implant the
`DiMatteo valve in the manner suggested or hypothesized by Dr. Catchings’
`testimony.” Hill Decl., ¶59.
`
`
`
`63
`
`See ‘110, Paper 25 at 13
`
`
`
`Petitioner’s Response to Norred’s Argument that DiMatteo
`Valve is not a Replacement for an Aortic Valve
` Norred argues in his declaration that DiMatteo’s valve may work in
`venous applications, but cannot work in the aorta. Norred Decl., ¶70
` This argument is absent from Norred’s Response to the Petition. See
`‘110, Response, Paper 15; ‘110, Pet. Reply, Paper 25 at 13. It
`therefore should not be considered. Fidelity Nat'l Info. Servs., Inc. v.
`DataTreasury Corp., IPR2014-00489, Paper 9 at 9 (Aug. 13, 2014);
`see also 37 C.F.R. §§42.22(a)(2) & 42.6(a)(3) (prohibits a party from
`incorporating by reference information and arguments in supporting
`documents that are not also discussed in the brief.)
` In any event, DiMatteo explicitly states that “the present invention
`relates to implantable … aortic … valves.” ‘110, Ex. 1003, 1:4-7.
` DiMatteo also discloses embodiments of “a prosthetic bicuspid valve
`210 … as a replacement aortic valve.” Id. at 14:50-58.
`
`64
`
`See ‘110, Paper 25 at 13
`
`
`
`Petitioner’s Response to Norred’s Argument that Wolfe
`Valve is not a Replacement for an Aortic Valve
` Norred’s expert, Dr. Catchings, states in his declaration that the
`embodiment shown in Figure 1 of Wolfe, “is supposed to be a mitral valve,
`not an aortic valve.” Catchings Tr., 261:17-23.
` This argument is absent from Norred’s Response to the Petition. See
`‘110, Response, Paper 15; ‘110, Pet. Reply, Paper 25 at 15. It therefore
`should not be considered. Fidelity Nat'l Info. Servs., Inc. v. DataTreasury
`Corp., IPR2014-00489, Paper 9 at 9 (Aug. 13, 2014); see also 37 C.F.R.
`§§42.22(a)(2) & 42.6(a)(3).
`In any event, Wolfe teaches that “the valve assemblies of this invention
`can also be adapted to replace … aortic valves.” ‘110, Ex. 1006, 1:49-51;
`see also Hill Decl., ‘110, Ex. 1026, ¶63 (“Dr. Catching’s testimony that
`Wolfe only relates to mitral valves “is incorrect, as Wolfe expressly
`explains that the disclosed valve can be used to replace aortic valves.”)
`“It is also well known that the valve of the type shown and described with
`respect to Wolfe could be used as an aortic valve.” Id., ¶63.
`
`
`
`
`
`65
`
`See ‘110, Paper 25 at 15
`
`
`
`Petitioner’s Response to Norred’s Argument that Wolfe’s
`Cuspid 38 not a “membrane”
`
`Norred argues:
`•
`“Cuspid 38 is molded of a rigid, plastic material.”
`•
`“T]he rigid nature of cuspid 38 is evident from the description of
`the preferred embodiments as well as Figs. 1, 2A, and 2B.”
`“Because cuspid 38 is a rigid structure, a person of ordinary skill
`in the art would not understand it to constitute a ‘membrane.’”
`
`•
`
`66
`
`See ‘110, Paper 15 at 37-40
`See also ‘110, Paper 25 at 14
`
`
`
`Description of Wolfe’s Cuspid 38
`
`‘110, Ex. 1006, Fig. 2C.
`
`‘110, Ex. 1006, Fig. 2B.
`
`“The cuspids are connected to the upstream annular section through
`flexible stems and are movable radially with respect to each other … the
`cuspids of the occluder are formed of a plastic material, such as
`polypropylene, which is light in weight, and easily formable into the desired
`configuration.” ‘110, Ex. 1006, 1:60-2:4
`67
`
`See ‘110, Paper 4 at Appendix-13; Paper 25 at 14.
`
`
`
`The Board Rejected Norred’s Argument that Wolfe’s
`Cuspid 38 is not a “membrane”
`
`•
`
`In its Decision to Institute, the Board acknowledged that Norred
`“contends that Wolfe does not teach a membrane movable
`between a first open position and a second closed position as
`claimed.” ‘110, Decision, Paper 10 at 14-15.
`• However, the Board rejected Norred’s argument, holding that “[w]e
`are not persua