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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________________
`
`
`
`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
`
`and MEDTRONIC COREVALVE, LLC
`
`Petitioner
`
`
`
`v.
`
`
`
`TROY R. NORRED, M.D.
`
`Patent Owner
`
`______________________
`
`
`
`Case IPR2014-00110
`
`Patent 6,482,228
`
`______________________
`
`
`
`PATENT OWNER RESPONSE
`
`PURSUANT TO 37 C.F.R. § 42.120
`
`
`
`
`
`
`
`

`

`
`
`TABLE OF CONTENTS
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`
`
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`I. BACKGROUND ..........................................................................................1
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`II. ARGUMENT ................................................................................................4
`
`A. Legal Standards ..........................................................................................4
`
`B. DiMatteo does not Anticipate Claims 16-19 of the ‘228 Patent ................6
`
`1. Norred Conceived his Invention Prior to DiMatteo and
`
`Exercised Reasonable Diligence in Constructively Reducing
`
`it to Practice..........................................................................................6
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`a. Conception ......................................................................................6
`
`b. Constructive Reduction to Practice .............................................. 14
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`c. Norred’s Inventive Process ........................................................... 16
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`d. Norred’s Efforts During the Critical Period ................................. 27
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`2. DiMatteo does not Disclose all of the Prior Art
`
`Elements as Arranged in Claims 16-19 of the ‘228 Patent .................. 30
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`a. Claim Construction....................................................................... 30
`
`b. DiMatteo does not Disclose a Ring Member ................................ 34
`
`3. Claims 16 and 18 of the ‘228 Patent are
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`not Anticipated by Wolfe ................................................................... 36
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`a. Claim Construction....................................................................... 37
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`b. Wolfe does not Disclose all Prior Art Elements as
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`Arranged in Claims 16 through 18 ................................................ 37
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`III. CONCLUSION .......................................................................................... 40
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`-ii-
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`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Advanced Display Sys., Inc. v. Kent State Univ.,
`
`212 F.3d 1272 (Fed. Cir. 2000) ............................................................................4
`
`Applied Med. Res. Cor. v. United States Surgical Corp.,
`
`147 F.3d 1374 (Fed. Cir. 1998) ............................................................................5
`
`Brown v. Barbacid,
`
`436 F.3d 1376 (Fed. Cir. 2006) .......................................................................... 14
`
`Burroughs Wellcome Co. v. Barr Labs., Inc.,
`
`40 F.3d 1223 (Fed. Cir. 1994) ..............................................................................6
`
`Connell v. Sears, Roebuck & Co.,
`
`722 F.2d 1542 (Fed. Cir. 1983) ................................................................ 4, 31, 34
`
`E.I. du Pont de Nemours & Co. v. Phillips Petroleum Co.,
`
`849 F.2d 1430 (Fed. Cir. 1988) .......................................................................... 27
`
`Frazier v. Schlegel,
`
`498 F.3d 1283 (Fed. Cir. 2007) .......................................................................... 14
`
`In re Mathews,
`
`408 F.2d 1393 (1969) ...........................................................................................5
`
`In re Spiller,
`
`500 F.2d 1170 (C.C.P.A. 1974) ...........................................................................6
`
`In re Tanczyn,
`
`347 F.2d 830 (C.C.P.A. 1965) ....................................................................... 6, 13
`
`In re Translogic Tech., Inc..,
`
`504 F.3d 1249 (Fed. Cir. 2007) .......................................................................... 27
`
`Jones v. Evans,
`
`46 F.2d 197 (C.C.P.A. 1931) ............................................................................. 26
`
`
`-iii-
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`

`

`
`
`K & K Jump Start/Chargers, Inc. v. Schumacher Elec. Corp., 8
`
`2 F. Supp.2d 1012 (W.D. Mo. 2000) ................................................................. 14
`
`Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co.,
`
`730 F.2d 1452 (Fed. Cir. 1984) ............................................................................4
`
`Mahurkar v. C.R. Bard, Inc.,
`
`79 F.3d 1572 (Fed. Cir. 1996) ............................................................................ 13
`
`Monsanto Co. v. Mycogen Plant Science, Inc.,
`
`261 F.3d 1356 (Fed. Cir. 2001) .......................................................................... 25
`
`Monsanto Co. v. Mycogen Plant Science, Inc.,
`
`61 F. Supp.2d 133 (D. Del. 1999) ...................................................................... 13
`
`Net Moneyin, Inc. v. Verisign, Inc.,
`
`545 F.3d 1359 (Fed. Cir. 2008) ................................................. 4, 5, 26, 31, 32, 35
`
`Renishaw PLC v. Marposs Societa’ per Azioni,
`
`158 F.3d 1243 (Fed. Cir. 1998) .......................................................................... 27
`
`Singh v. Brake,
`
`317 F.3d 1334 (Fed. Cir. 2003) ............................................................................6
`
`Stamicabon BV v. Sepracor, Inc., No. Civ.A. 97-8-GMS,
`
`2001 WL 253118 (D. Del. March 12, 2001) ...................................................... 13
`
`Statutes
`
`35 U.S.C. § 102 ............................................................................................ 4, 5, 42
`
`35 U.S.C. § 102(b) ..................................................................................................4
`
`35 U.S.C. § 102(e) ............................................................................ 4, 6, 29, 30, 34
`
`35 U.S.C. § 42.107 ..................................................................................................3
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`37 C.F.R. § 42.100(b) ........................................................................................... 30
`
`37 C.F.R. § 42.120 ..................................................................................................4
`
`
`-iv-
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`

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`
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`Other Authorities
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`Office Patent Trial Practice Guide, 77 Fed. Reg. 48756 (Aug. 14, 2012) ............. 33
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`-v-
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`

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`I.
`
`BACKGROUND
`
`On October 31, 2013, Medtronic, Inc., Medtronic Vascular, Inc. and
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`Medtronic CoreValve, LLC (collectively, “Medtronic” or “Petitioner”) filed a
`
`Petition requesting inter partes review of U.S. Patent No. 6,482,228 (the “‘228
`
`Patent”). In its Petition, Medtronic challenged the patentability of claims 16-19
`
`of the ‘228 Patent on the ground that these claims were anticipated by prior art.
`
`Claims 16-19 are reproduced below:
`
`16. An aortic valve for regulating a blood flow through an
`
`aortic channel surrounded by an aortic wall upon placement
`
`therein, said valve comprising:
`
`a ring member having a circumference adapted to seat about
`
`an aortic wall surrounding an aortic channel, said ring
`
`including an aperture for blood flow therethrough;
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`a membrane having first and second spaced-apart open ends,
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`said membrane made of a material resistant to a fluid flow
`
`therethrough; and
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`means for mounting said first open end of said membrane
`
`about said ring aperture with said second open end
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`-1-
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`displaced therefrom, said means moving said membrane
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`second end between a first open position to allow a blood
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`flow therethrough and a second closed position to
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`preclude a blood flow therethrough.
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`17. The aortic valve as claimed in claim 16 wherein said
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`mounting means comprises at least one arm having a first end
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`hingedly secured to said ring member and a free end spaced
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`therefrom, said first end of said at least one arm secured to said first
`
`end of said membrane, said free end of said at least one arm secured
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`to said second end of said membrane, said at least one arm
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`responsive to a blood flow within the channel for movement with
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`said membrane between said first open and second closed positions.
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`18. The aortic valve as claimed in claim 17 wherein said at
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`least one arm extends generally along a path of said blood flow at
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`said first open position, and generally traverses a blood flow path
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`when at said second closed position.
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`-2-
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`

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`19. The aortic valve as claimed in claim 16 further
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`comprising means for maintaining said ring member in said seat
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`about the aortic wall.
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`Medtronic presented four prior art references for consideration by
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`the Patent Trial and Appeal Board (the “Board”). These references were
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`DiMatteo, US 6,440,164 B1, published August 27, 2002, Exhibit 1003; Kischer,
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`US 3,548,417, published December 22, 1970, Exhibit 1004; Shaolian,
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`US 6,299,637, published October 9, 2001, Exhibit 1005; and Wolfe,
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`US 4,030,142, published June 21, 1977, Exhibit 1006.
`
`On February 6, 2014, Patent Owner Troy R. Norred, M.D.
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`(“Norred”) filed a preliminary response to the Petition under 35 U.S.C. § 42.107
`
`presenting arguments why an inter partes review should not be instituted.
`
`Norred argued his invention predated two of the prior art references relied upon
`
`by Medtronic, and that neither these two references nor the remaining
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`references contained all the elements of claims 16-19 of the ‘228 Patent.
`
`On April 25, 2014, the Board issued a decision instituting an inter
`
`partes review of the ‘228 Patent based on the followed grounds:
`
`
`
`Claims 16-19 under 35 U.S.C. § 102(e) over DiMatteo; and
`
`
`-3-
`
`

`

`
`
`
`
`Claims 16-18 under 35 U.S.C. § 102(b) over Wolfe.
`
`The Board denied Petitioner’s remaining grounds as redundant.
`
`The following Response is submitted pursuant to 37 C.F.R.
`
`§ 42.120, which authorizes the patent owner to file a response to a petition
`
`addressing any ground for unpatentability not already denied.
`
`II. ARGUMENT
`
`A.
`
`Legal Standards
`
`A patent may be found invalid as anticipated if “the invention was
`
`described in . . . a patent granted on an application for patent by another filed in
`
`the United States before the invention thereof by the applicant for patent.” See
`
`35 U.S.C. § 102(e). A claim is anticipated when “the four corners of a single,
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`prior art document describe every element of the claimed invention, either
`
`expressly or inherently, such that a person of ordinary skill in the art could
`
`practice the invention without undue experimentation.” Advanced Display Sys.,
`
`Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000).
`
`“Because the hallmark of anticipation is prior invention, the prior
`
`art reference—in order to anticipate under 35 U.S.C. § 102—must not only
`
`disclose all elements of the claim within the four corners of the document, but
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`
`-4-
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`
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`must also disclose those elements ‘arranged as in the claim.’” Net Moneyin, Inc.
`
`v. Verisign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (citing Connell v. Sears,
`
`Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). The requirement that the
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`prior art elements be “arranged as in the claim” means that claims cannot be
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`“treated ... as mere catalogs of separate parts, in disregard of the part-to-part
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`relationships set forth in the claims and that give the claims their meaning.”
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`Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452,
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`1459 (Fed. Cir. 1984). A prior art device does not anticipate “simply by
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`possessing identically named parts, unless these parts also have the same
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`structure or otherwise satisfy the claim limitations.” Applied Med. Res. Cor. v.
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`United States Surgical Corp., 147 F.3d 1374, 1380 (Fed. Cir. 1998). “[U]nless a
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`reference discloses within the four corners of the document not only all of the
`
`limitations claimed but also all of the limitations arranged or combined in the
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`same way as recited in the claim, it cannot be said to prove prior invention of
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`the thing claimed and, thus, cannot anticipate under 35 U.S.C. § 102.” Net
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`MoneyIN, 545 F.3d at 1371. Finally, a reference patent anticipates an invention
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`only if the reference patent’s effective filing date is before the date of the
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`invention. See In re Mathews, 408 F.2d 1393 (1969).
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`-5-
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`B. DiMatteo does not Anticipate Claims 16-19 of the ‘228 Patent
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`DiMatteo was filed on October 21, 1999 and is alleged to anticipate
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`claims 16-19 of the ‘228 Patent under 35 U.S.C. § 102(e). This allegation is
`
`without merit. DiMatteo does not anticipate claims 16-19 of the ‘228 Patent
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`because Norred conceived his invention prior to DiMatteo, and exercised
`
`reasonable diligence in constructively reducing it to practice. Further, DiMatteo
`
`does not disclose all of the prior art elements as arranged in claims 16-19.
`
`1. Norred Conceived his Invention Prior to DiMatteo and
`
`Exercised Reasonable Diligence in Constructively Reducing it to
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`Practice
`
`a.
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`Conception
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`“Conception is the formation in the mind of the inventor of a
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`definite and permanent idea of the complete and operative invention, as it is
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`therefore to be applied in practice.” Singh v. Brake, 317 F.3d 1334, 1340
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`(Fed. Cir. 2003). An idea is sufficiently definite for conception “when the
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`inventor has a specific, settled idea, a particular solution to the problem at hand,
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`not just a general goal or research plan he hopes to pursue.” Burroughs Wellcome
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`Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994). A finding of
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`-6-
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`

`
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`conception does not require perfection; conception is complete when “the idea is
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`so clearly defined in the inventor’s mind that only ordinary skill would be
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`necessary to reduce the invention to practice, without extensive research or
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`experimentation.” Id.; see also In re Spiller, 500 F.2d 1170, 1178 (C.C.P.A. 1974)
`
`(discussing requirements of a Rule 131 affidavit); In re Tanczyn, 347 F.2d 830
`
`(C.C.P.A. 1965) (same).
`
`Norred conceived of his invention no later than December 21, 1998.
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`Declaration of Troy R. Norred, M.D. (“Norred Decl.”), ¶ 27, filed as Exhibit 2093.
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`This is shown by the drawing identified as Exhibit 2003. See Burroughs, 40 F.3d
`
`at 1228 (conception is shown “when the inventor has a specific, settled idea, a
`
`particular solution to the problem at hand”). This drawing is signed and
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`notarized and bears a date of “12/21/98.” Exhibit 2003. It depicts each
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`limitation set forth in claims 16 and 19 of the ‘228 Patent as follows (the
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`handwritten notes were part of the original drawing while the typewritten
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`annotations were added for this filing):
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`-7-
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`-8-
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`16. An aortic valve for regulating a
`blood flow through an aortic channel
`surrounded by an aortic wall upon
`placement therein
`
`

`

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`-9-
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`16(a) a ring member
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`16(a)(1) a circumference adapted to
`seat about an aortic wall
`surrounding an aortic channel
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`16(a)(2) an aperture for blood flow
`therethrough
`
`

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`-10-
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`16(b)(2) second space-apart open
`end[s]
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`16(b)(1) first [open end]
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`16(b)(3) made of a
`material resistant to a
`fluid flow therethrough
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`16(b) a membrane
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`-11-
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`16(c) means for mounting said first
`open end of said membrane about
`said ring aperture with said second
`open end displaced therefrom
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`16(c)(1) a first open position to allow
`a blood flow therethrough
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`16(c)(2) a second closed position to
`preclude a blood flow therethrough
`
`

`

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`-12-
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`19. The aortic valve as claimed in
`claim 16 further comprising means
`for maintaining said ring member in
`said seat about the aortic wall.
`
`

`

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`
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`This drawing served as the basis for Figures 4 and 18 of the ‘228
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`Patent. Norred Decl. ¶ 8. Figure 4 generally depicts the stent system 28 as
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`deployed in the aortic channel. Id. Figure 18 depicts in detail how the stent
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`system can be attached to the ring member 102 through connecting rods 104. Id.
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`This drawing combines these structures, showing the stent system as deployed in
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`the aorta, attached through connecting rods to the ring member. Id.
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`
`-13-
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`19. The aortic valve as claimed in
`claim 16 further comprising means
`for maintaining said ring member in
`said seat about the aortic wall.
`
`

`

`
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`Based on this drawing, there can be no question that Norred was in
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`possession of his invention by December 21, 1998. Claims 16-19 clearly read on
`
`this design. This is sufficient for December 21, 1998 to serve as the date of
`
`conception. Cf. Tanczyn, 347 F.2d at 833 (Rule 131 declaration is sufficient if it
`
`establishes possession of the whole invention or something falling with a claim).
`
`
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`b. Constructive Reduction to Practice
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`“Where a party is the first to conceive the invention but reduces it
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`to practice after another party’s reduction to practice, the party that was the first
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`to conceive the invention will be the first inventor if he can show reasonable
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`diligence during the time from a date just prior to the conception date of the
`
`other party until the party that was the first to conceive the invention reduces it
`
`to practice.” Monsanto Co. v. Mycogen Plant Science, Inc., 61 F. Supp.2d 133, 180
`
`(D. Del. 1999) (citing Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577-79 (Fed.
`
`Cir. 1996)). “The Federal Circuit defines diligence as reasonably continuous
`
`activity toward reduction to practice so that the invention’s conception and
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`reduction to practice are substantially one continuous act.” Id. (citing Mahurkar,
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`79 F.3d at 1577). “Diligence must be considered in light of all the circumstances
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`and the question to answer is whether the inventor was pursing his goal in
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`
`-14-
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`reasonably continuous fashion.” Id. In answering this question, the Board may
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`take
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`into account the reasonable, everyday problems and
`
`limitations
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`encountered by the inventor. Stamicabon BV v. Sepracor, Inc., No. Civ.A. 97-8-
`
`GMS, 2001 WL 253118, at *6 (D. Del. March 12, 2001). “[T]he law only
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`requires reasonable (and not heroic) diligence” and “an inventor need not
`
`abandon his or her means of livelihood in order to be ‘diligent.’” K & K Jump
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`Start/Chargers, Inc. v. Schumacher Elec. Corp., 82 F. Supp.2d 1012, 1022 (W.D.
`
`Mo. 2000).
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`Norred’s sworn testimony, corroborated by documentary evidence,
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`demonstrates Norred exercised reasonable diligence during the time period
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`beginning before just before October 21, 1999 (when the DiMatteo patent
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`application was filed) and ending on November 20, 2000 (when his own patent
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`application was filed). See Frazier v. Schlegel, 498 F.3d 1283, 1288 (Fed. Cir. 2007)
`
`(“The filing of a patent application is a constructive reduction to practice of the
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`invention disclosed therein”); Brown v. Barbacid, 436 F.3d 1376, 1380-81 (Fed.
`
`Cir. 2006) (“The basic inquiry is whether, on all of the evidence, there was
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`reasonably continuing activity to reduce the invention to practice”).
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`-15-
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`c. Norred’s Inventive Process
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`At the time Norred conceived his invention, he was in the
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`fellowship program at the University Hospital of the University of Missouri.
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`Norred Decl. ¶ 21. He was on duty five to seven nights per week, from 5:00 a.m.
`
`until midnight each day, for an average workweek of 110 hours. Norred Decl.
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`¶ 22. In addition, in order to support his wife and children, he supplemented his
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`fellowship salary by moonlighting as an emergency room physician at the VA
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`Hospital in Columbia, Missouri, and later at St. Mary’s Hospital in St. Louis,
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`Missouri. Norred Decl. ¶¶ 23, 24.
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`Norred’s fellowship duties, coupled with his moonlighting work as
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`an emergency room physician, left him with little time to refine or test his
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`hypotheses for a new aortic valve design. Norred Decl. ¶¶ 25, 26. Nonetheless,
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`he made judicious use of whatever time was available to keep pressing forward.
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`By way of example, he created the drawing referenced as Exhibit 2003 while he
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`was home on winter break. Norred Decl. ¶ 27.
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`Because of the nature of his fellowship, Norred was around
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`interventional cardiologists every day during this time period. Norred Decl. ¶ 28.
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`He witnessed firsthand the therapies they were administering to patients and the
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`-16-
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`types of tools they had available, such as catheters and stents. Norred Decl. ¶ 28.
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`As these tools were discarded, he took them home and deconstructed them to
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`attempt to determine how they might work with a prosthetic aortic valve.
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`Norred Decl. ¶ 28.
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`Norred ordered a plastic model of the aorta and coronary arteries
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`through the VA, so he could better visualize and understand how a prosthetic
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`aortic valve might be placed percutaneously. Norred Decl. ¶ 29. He explored
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`ways of testing his concepts to determine whether they were sound. Norred
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`Decl. ¶ 29.
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`As a proof of concept, for his second-year fellowship project,
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`Norred proposed to place an enclosed stent within a porcine aorta, pressurize
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`the tube, and then experimentally derive the amount of surface area needed to
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`contain particular amounts of pressure. Norred Decl. ¶¶ 30, 31. His goals, as
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`stated in the proposal, were “to prove through surface adherence alone a stent
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`could seat an aortic valve and withstand arterial force,” and to “experimentally
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`derive the surface area needed.” Norred Decl. ¶ 31. Exhibit 2004 is a copy of the
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`proposal.
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`-17-
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`Norred submitted his proposal to Dr. Richard Davis, an Associate
`
`Professor of Cardiology at the University of Missouri School of Medicine, on
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`May 26, 1999. Norred Decl. ¶ 32. Dr. Davis inquired about the cost of the
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`project Norred proposed. Norred Decl. ¶ 33. Norred made several calls to
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`determine the price of the raw materials. Norred Decl. ¶ 33. It took Norred
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`until early June 1999 to obtain this information, and he submitted it to
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`Dr. Davis immediately thereafter. Norred Decl. ¶ 34. His notes from these calls
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`are Exhibit 2082. Norred Decl. ¶ 33. Approximately a month passed before
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`Norred heard back from Dr. Davis. Dr. Davis rejected the proposal. Norred
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`Decl. ¶ 34. He said, without elaboration, that he did not like Norred’s idea.
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`Norred Decl. ¶ 34.
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`During roughly this same time period, Norred became aware that
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`the Department of Veterinary Medicine had received a grant for a project that
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`involved placing stents in the coronary arteries of pigs. Norred Decl. ¶ 35. As
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`part of the project, there was a need for trained surgeons who could perform pig
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`catheterizations. Norred Decl. ¶ 35. Norred volunteered, believing this would
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`help him learn more about pig anatomy, with the ultimate goal of using live pigs
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`to test his stent concept. Norred Decl. ¶ 35. Norred spent four hours per week
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`-18-
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`on this project, from summer 1999 through fall 1999. This project was overseen
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`by Drs. Michael Sturek and H.K. Reddy. Norred Decl. ¶ 35.
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`Also during this time period, Norred explored whether it would be
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`possible to mathematically model an aortic stent, to determine whether the stent
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`could withstand the pressures within the aorta and, if so, the amount of surface
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`area required. Norred Decl. ¶ 36. Norred believed this would provide the
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`foundation for live animal testing. Norred Decl. ¶ 36. It would help him
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`convince others of the appropriateness of the tests, and inform him how large
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`the test stents should be. Norred Decl. ¶ 36.
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`Norred made contact with Dr. Fu-Hung Hsieh, a Professor of
`
`Biological Engineering at the University of Missouri. Norred Decl. ¶ 36.
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`Dr. Hsieh expressed a willingness to help, but had no experience working with
`
`the human anatomy. Norred Decl. ¶ 36. As a result, Norred had to teach
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`Dr. Hsieh about the biology of the human heart and related anatomical
`
`structures so that he could give Norred the help he required. Norred Decl. ¶ 36.
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`This took considerable time, in part because Dr. Hsieh spoke limited English.
`
`Norred Decl. ¶ 36.
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`-19-
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`Norred met with Dr. Hsieh on a regular basis from September 1999
`
`through March 2000 as often as their schedules would allow. Norred Decl. ¶ 37.
`
`The meetings lasted hours. Norred Decl. ¶ 37. Norred shared with Dr. Hsieh
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`Norred’s detailed knowledge about how the heart functioned, and Dr. Hsieh
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`shared with Norred his engineering ideas. Norred Decl. ¶ 37. Dr. Hsieh also
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`introduced Norred to personnel in the physical plant at the University of
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`Missouri. Norred Decl. ¶ 37. The physical plant built whatever the Department
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`of Engineering required. Norred Decl. ¶ 37.
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`Norred convinced personnel in the physical plant to assist him with
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`creating a rough prototype of his invention. Norred Decl. ¶ 38. Norred
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`purchased pig hearts from a local slaughterhouse, froze them with liquid
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`nitrogen, and injected them with epoxy. Norred Decl. ¶ 38. Once the epoxy
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`hardened, he removed it. Norred Decl. ¶ 38. He then took a cast of the epoxy
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`using cement. Norred Decl. ¶ 38. This gave him a cement model of the aorta and
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`the aortic valve contained therein. Norred Decl. ¶ 38. He heated a slotted
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`Nitinol tube and pressed it over the aortic valve cast to create a Nitinol stent.
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`Norred Decl. ¶ 38.
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`Dr. Greg Flaker, the Interim Director of the Division of Cardiology
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`at the University of Missouri, praised Norred for developing this prototype.
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`Norred Decl. ¶ 39. Exhibit 2083 is a letter from Dr. Flaker to Norred
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`memorializing a prior, in-person meeting between the two of them regarding
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`this work and the status of Norred’s fellowship. Norred Decl. ¶ 39.
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`Ultimately, Dr. Hsieh was unable to develop the mathematical
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`model Norred needed for a proof of concept. Norred Decl. ¶ 40. He referred
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`Norred to Dr. Stephen J. Lombardo for further guidance. Norred Decl. ¶ 40.
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`Dr. Lombardo was an Assistant Professor in the Department of Chemical
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`Engineering at the University of Missouri. Norred Decl. ¶ 41. Norred spoke
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`with Dr. Lombardo by phone in March 2000 and explained to him what he
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`(Norred) was trying to accomplish. Norred Decl. ¶ 41. Dr. Lombardo agreed to
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`help, picking up where Dr. Hsieh had left off. Norred Decl. ¶ 41.
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`For the next few months, from April 2000 until June 2000, Norred
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`worked with Dr. Lombardo on the project. Norred Decl. ¶ 42. They spoke two
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`or three times per month, with Norred giving Dr. Lombardo the same sort of
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`information he had given to Dr. Hsieh. Norred Decl. ¶ 42. Norred also reviewed
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`scores of peer-reviewed articles on treatments for aortic stenosis, hoping to gain
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`information regarding such things as the size of stents used in existing
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`treatments, the size of angioplasty balloons used in existing treatments, and the
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`pressure utilized in such balloons in order to open aortic passageways. Norred
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`Decl. ¶ 42. Norred spent 10 to 15 hours per week pouring over these articles,
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`believing
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`this
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`information
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`could help
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`augment
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`and/or
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`accelerate
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`Dr. Lombardo’s work. Norred Decl. ¶ 42. Norred efforts are illustrated by
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`Exhibit 2032, an order for certain of the articles Norred sought to review.
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`Norred Decl. ¶ 42.
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`On May 5, 2000, Norred met with James J. Kernell, a patent
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`attorney with the law firm then known as Chase & Yakimo, L.C. Norred Decl.
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`¶ 43. By this point, Norred had devoted countless hours to his idea for a
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`percutaneously-placed, prosthetic aortic valve. Norred Decl. ¶ 43. Norred
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`believed, based on comments he received from Drs. Hsieh and Lombardo as well
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`as his own research and experimentation, his idea was viable and would
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`revolutionize the treatment of aortic stenosis. Norred Decl. ¶ 43. Norred wanted
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`to protect his idea, and so he retained Mr. Kernell to prepare and file a patent
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`application on his behalf. Norred Decl. ¶ 43.
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`Norred provided Mr. Kernell with sketches of the new valve and
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`background information on how the valve would work. Norred Decl. ¶ 43.
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`These materials are collected as Exhibit 2050.
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` Norred subsequently
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`commissioned and provided Mr. Kernell with a computer animation showing
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`the prosthetic valve being placed in the aorta, and how the valve opened and
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`closed in response to blood being pumped by the heart. Norred Decl. ¶ 43. Later,
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`Norred provided Mr. Kernell with computer animations of select embodiments
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`of the invention. Norred Decl. ¶ 43.
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`Mr. Kernell used these materials and the information he received
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`from Norred to complete the patent application. Declaration of James J. Kernell,
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`Kernell Decl. ¶ 4, filed as Exhibit 2094. Because of the complexity of the
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`invention and Mr. Kernell’s unfamiliarity with the anatomical structures and
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`concepts involved, this was a labor- and time-intensive process. Kernell Decl. ¶ 5.
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`Mr. Kernell spent in excess of 80 hours on this project from the time he first met
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`with Norred to the time he provided Norred with a draft patent application.
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`Kernell Decl. ¶ 4. During this time period, Mr. Kernell also worked on several
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`other matters. Kernell Decl. ¶¶ 6-31. He worked on these matters in
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`chronological order, except to the extent applicable filing deadlines necessitated
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`affording particular matters a different priority. Kernell Decl. ¶ 6.
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`As Mr. Kernell continued to work on the patent application,
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`Dr. Lombardo completed his work on the mathematical model. Norred Decl.
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`¶ 44. Through mathematical derivation, Dr. Lombardo was able to develop a
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`load-bearing equation confirming that a prosthetic aortic valve could be held in
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`place by a stent that was well within the size range tolerated by the adult human
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`anatomy. Norred Decl. ¶ 44. Dr. Lombardo provided Norred with the initial
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`draft of this equation on July 7, 2000, as reflected in Exhibit 2084. See also
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`Declarations of Dr. Stephen J. Lombardo, filed as Exhibit 2096, and Dr. Carl T.
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`Rutledge, filed as Exhibit 2097.
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`From early summer through early fall 2000—spurred on by earlier
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`encouragement from Dr. Flaker—Norred devoted substantial time to preparing
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`a proposal for his fellowship project that would enable him to test his invention.
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`Norred Decl. ¶ 45. Norred hoped to demonstrate the feasibility of a
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`percutaneously-placed aortic valve using 10 live pigs as models. Norred Decl.
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`¶ 45. Norred worked on the proposal on a daily basis, and it went through
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`numerous iterations. Norred Decl. ¶ 46. The earliest drafts were somewhat
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`-24-
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`rudimentary, and provided little background on the need for or utility of the
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`invention. Norred Decl. ¶ 46. These drafts are typified by Exhibit 2037.
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`Over time, Norred incorporated more and more background
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`information, hoping to bolster the likelihood that his proposal would be
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`accepted. Norred Decl. ¶ 47. Exhibits 2041, 2042 and 2051 show the progression
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`of his work. These drafts include an extensive discussion of the aortic valve
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`anatomy as well as the risks and complications of surgical therapy. Norred Decl.
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`¶ 47.
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`Exhibit 2085 is the final version of Norred’s proposal. Norred Decl.
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`¶ 48. With revisions, it took over 150 hours to complete. Norred Decl. ¶ 48. It
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`details the costs associated with the project and the people he intended to enlist
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`for help, including Drs. Hsieh and Lombardo. Norred Decl. ¶ 48.
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`As Norred was working on his proposal, he reached out to medical
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`device manufacturers such as Guidant Corporation, Boston Scientific and
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`Medtronic to gauge their interest in participating in the project. Norred Decl.
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`¶ 49. Exhibit 2017 is a mutual confidentiality agreement he faxed to a Guidant
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`representative on July 28, 2000 to facilitate communications regarding Norred’s
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`invention. Exhibits 2078 and 2079 are copies of the business cards of some of
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`the other manufacturer representatives with whom Norred spoke. Norred Decl.
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`¶ 49.
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`In fall 2000, Norred submitted his proposal to Dr. Flaker. Norred
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`Decl. ¶ 50. Dr. Flaker said he would approve the project if Norred first could
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`secure approval from Dr. Sturek in the Department of Veterinary Medicine.
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`Norred Decl. ¶ 50. Dr. Flaker directed Norred to Dr. Sturek because Dr. Sturek
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`already had experience placing stents in live pigs. Norred Decl. ¶ 50.
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`Despite persistent efforts, Norred was unable to obtain Dr. Sturek’s
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`approval for the project. Norred Decl. ¶ 51. Norred could not convince
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`Dr. Sturek that a stent could be used to anchor a prosthetic valve in the aorta.
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`Norred Decl. ¶ 51. This lef