IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________
`
`EDWARDS LIFESCIENCES CORPORATION,
`Petitioner,
`
`v.
`
`ENDOHEART AG
`Patent Owner.
`__________________
`
`Case IPR2016-00300
`U.S. Patent No. 8,182,530
`__________________
`
`
`REPLACEMENT PETITION
`FOR INTER PARTES REVIEW OF CLAIMS 1 AND 6 OF
`
`U.S. PATENT NO. 8,182,530
`
`UNDER 35 U.S.C. § 312 AND 37 C.F.R. § 42.104
`
`
`
`
`
`Edwards Exhibit 1045, pg. 1
`Edwards vs. Endoheart
`IPR2016-00300
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`

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`Petition for Inter Partes Review of U.S. Patent No. 8,182,530
`
`
`TABLE OF CONTENTS
`
` I.
`
`II.
`
`OVERVIEW OF PETITION ........................................................................... 1
`
`STATE OF THE ART IN THE 2003 TO 2004 TIME FRAME ..................... 5
`
`A. Known Valve Prosthesis Implantation Techniques Included the
`Antegrade Approach ........................................................................... 5
`
`B. Treating the Aortic Valve via a Transapical Approach
`and Crossing the Aortic Valve with a Guidewire Were
`Well Known Techniques .................................................................... 8
`
`C. Guidewires Were Well-Known, Off-the-Shelf Equipment Used
`to Guide Other Equipment/Prostheses ............................................ 15
`
`D. Installing an Access Device in the Heart Was a Known
`Step in the Transapical Approach ..................................................... 17
`
`III. MANDATORY NOTICES - 37 C.F.R. § 42.8(A)(1) ................................... 20
`
`A. Real Party-in-Interest - 37 C.F.R. § 42.8(b)(1) .................................. 20
`
`B. Related Matters - 37 C.F.R. § 42.8(b)(2) ............................................ 20
`
`C. Lead and Back-up Counsel - 37 C.F.R. § 42.8(b)(3) ......................... 21
`
`D. Service Information - 37 C.F.R. § 42.8(b)(4) ..................................... 21
`
`IV. PAYMENT OF FEES - 37 C.F.R. § 42.103 ................................................. 22
`
`V.
`
`REQUIREMENTS FOR INTER PARTES REVIEW .................................... 22
`
`A. Grounds for Standing- 37 C.F.R. § 42.104(a) .................................... 22
`
`B. Identification of Claims for Which Review Is Requested and
`Relief Is Requested– 37 C.F.R. §§ 42.104(b)(1) and
`42.22(a)(1) ........................................................................................ 22
`
`C. Prior Art Patents and Printed Publications ......................................... 22
`
`D. Statutory Grounds of Challenge – 37 C.F.R. § 42.104(b)(2) ............. 23
`
`
`
`i
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`Edwards Exhibit 1045, pg. 2
`Edwards vs. Endoheart
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`Petition for Inter Partes Review of U.S. Patent No. 8,182,530
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`VI. THE ‘530 PATENT ....................................................................................... 24
`
`A. Disclosure of the ‘530 Patent ............................................................. 24
`
`B. Prosecution History of the ‘530 Patent ............................................... 26
`
`C. Claim Construction - 37 C.F.R. § 42.104(b)(3) .................................. 31
`
`VII. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 35
`
`VIII. IDENTIFICATION OF HOW THE CHALLENGED CLAIMS
`ARE UNPATENTABLE - 37 C.F.R. §§ 42.104(B)(4)-(5) AND
`42.22(A)(2) .................................................................................................... 36
`
`A. Ground 1: Claims 1 and 6 are Obvious Over Cribier in View
`of Neish and Lattouf ......................................................................... 36
`
`B. Ground 2: Claims 1 and 6 are Obvious Over Lattouf in View
`of Spenser ......................................................................................... 47
`
`IX. CONCLUSION .............................................................................................. 60
`
`ii
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`Edwards Exhibit 1045, pg. 3
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`Petition for Inter Partes Review of U.S. Patent No. 8,182,530
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`
`LIST OF EXHIBITS
`
`
`
`
`
`No.
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`Exhibit
`U.S. Patent No. 8,182,530 (“the ‘530 patent”).
`Prosecution History for U.S. Patent Application No. 11/023,783,
`which matured into the ‘530 patent (“‘783 Patent Application”).
`U.S. Provisional Patent Application No. 60/615,009, provisional
`application to which the ‘530 patent claims priority (“‘009
`Provisional Patent Application”).
`Bergheim, Bjarne. “Method and System for Cardiac Valve
`Delivery.” U.S. Patent Application Publication No. 2005/0240200
`(filed 2004) (“Bergheim”).
`Lattouf, Omar M. “Treatment for Patient with Congestive Heart
`Failure.” U.S. Patent Application Publication No. 2003/0130571
`(2003) (“Lattouf”).
`Huber, Christoph H., et al. “Direct-Access Valve Replacement: A
`Novel Approach for Off-Pump Valve Implantation Using Valved
`Stents.” J Am Coll Cardiol, 46(2):366-370, 369 (2005).
`Andersen, Henning R., et al. “Transluminal Implantation of Artificial
`Heart Valves. Description of a New Expandable Aortic Valve and
`Initial Results with Implantation by Catheter Technique in Closed
`Chest Pigs.” Eur Heart J, 13:704-708 (1992) (“Andersen”).
`Bonhoeffer, Philipp, et al. “Percutaneous Replacement of Pulmonary
`Valve in a Right-Ventricle to Pulmonary-Artery Prosthetic Conduit
`with Valve Dysfunction.” Lancet, 356:1403-1405 (2000).
`Cribier, Alain, et al. “Percutaneous Transcatheter Implantation of an
`Aortic Valve Prosthesis for Calcific Aortic Stenosis.” Circulation,
`106:3006-3008 (2002) (“Cribier”).
`Spenser, Benjamin, et al. “Implantable Prosthetic Valve.” U.S.
`Patent Publication No. 2003/0114913 (2003) (“Spenser”).
`Zhou, Jun Qing, et al. “Self-Expandable Valved Stent of Large Size:
`Off-Bypass Implantation in Pulmonary Position.” Eur J Cardio-
`Thorac Surg, 24:212-216 (2003) (“Zhou”).
`Golding, Leonard, A. R. “New Cannulation Technique for the
`Severely Calcified Ascending Aorta.” J Thorac Cardiovasc Surg,
`90(4):626-627, 626 (Oct., 1985) (“Golding”).
`1013 Wong, C. M., et al. “Percutaneous Left Ventricular Angiography.”
`Catheter Cardio Diag, 7:425-432 (1981) (“Wong”).
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`iii
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`Edwards Exhibit 1045, pg. 4
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`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`Lurie, Paul R., et al. “An Apical Technic for Catherization of the
`Left Side of the Heart Applied to Infants and Children.” New Engl J
`Med, 264(23):1182-1187 (1961) (“Lurie”).
`Maxwell, Darryl, et al. “Balloon Dilatation of the Aortic Valve in the
`Fetus: A Report of Two Cases.” Br Heart J, 65:256-258 (1991)
`(“Maxwell”).
`Neish, Steven R., et al. “Intraoperative Balloon Valvuloplasty for
`Critical Aortic Valvular Stenosis in Neonates.” Am J Cardiol,
`68:807- 810 (1991) (“Neish”).
`Tworetzky, Wayne, et al. “Balloon Dilation of Severe Aortic
`Stenosis in the Fetus: Potential for Prevention of Hypoplastic Left
`Heart Syndrome Candidate Selection, Technique, and Results of
`Successful Intervention.” Circulation, 110:2125-2131 (2004)
`(“Tworetzky”).
`Haase, Karl, et al. “Method and Apparatus for Crossing a Heart
`Valve.” U.S. Patent Application Publication No. 2004/0153135
`(2004) (“Haase”).
`Biagtan, Emmanuel, et al. “Guide Wire with Operator Controllable
`Tip Stiffness.” U.S. Patent No. 6,146,339 (2000) (“Biagtan”).
`1020 Mortier, Todd J., et al. “Transventricular Implant Tools and
`Devices.” U.S. Patent No. 6,746,471 (filed 2001) (“Mortier”).
`Gabbay, Shlomo. “Low Invasive Implantable Cardiac Prosthesis and
`Method for Helping Improve Operation of a Heart Valve.” U.S.
`Patent Application Publication No. 2003/0199975 (2003)
`(“Gabbay”).
`Seguin, Jacques, et al. “Prosthetic Valve for Transluminal Delivery.”
`U.S. Patent Application Publication No. 2004/0093060 (filed 2003)
`(“Seguin I”).
`Seguin, Jacques, et al. “Prosthetic Valve for Transluminal Delivery.”
`U.S. Patent Application Publication No. 2004/0210304 (filed 2004)
`(“Seguin II”).
`Semple, T. “Left Heart Catherization by Direct Ventricular
`Puncture.” Brit Heart J, 30:402-406 (1968) (“Semple”).
`U.S. Provisional Patent Application No. 60/340,062, provisional
`application to which Lattouf (Ex. 1005) claims priority (“‘062
`Provisional Patent Application”).
`Declaration of Dr. John R. Garret, M.D.
`Endoheart AG’s Responsive Claim Construction Brief filed Nov. 20,
`2015 in the United States District Court for the District of Delaware,
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`1027
`
`
`
`iv
`
`Edwards Exhibit 1045, pg. 5
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`
`1028
`
`1030
`
`1031
`
`1032
`
`1033
`1034
`
`C.A. No. 14-1473.
`
`Cribier, Alain, et al. “Percutaneous Transluminal Valvuloplasty of
`Acquired Aortic Stenosis in Elderly Patients: An Alternative to
`Valve Replacement? Lancet, 1:63-67 (1986).
`1029 McKay, Raymond, G., et al. “The Mansfield Scientific Aortic
`Valvuloplasty Registry: Overview of Acute Hemodynamic Results
`and Procedural Complications.” JACC, 17(2):485-491 (1991).
`Bashore, Thomas, M., et al. “Follow-up Recatherization After
`Balloon Aortic Valvuloplasty.” JACC, 17(5):1188-1195 (1991).
`Cribier, Alain, et al. “Trans-Catheter Implantation of Balloon-
`Expandable Prosthetic Heart Valves: Early Results in an Animal
`Model.” Circulation, 104(17), II-552:2609 (2001).
`Zhou, Junqing. “Chirurgie Valvulaire Par Voie Endovasculaire.”
`Thesis (2003) (“Zhou’s Thesis”).
`Declaration of Celina (Schwartz) Candolfi
`Gott, Vincent L., et al. “Mechanical Heart Valves: 50 Years of
`Evolution.” Ann Thorac Surg, 76:S2230-2239 (2003).
`1035 McClure, Scott R., et al. “Late Outcomes for Aortic Valve
`Replacement with the Carpentier-Edwards Pericardial Bioprosthesis:
`Up to 17-Year Follow-Up in 1,000 Patients.” Ann Thorac Surg,
`89:1410-1416 (2010).
`Schneider, Peter A., ENDOVASCULAR SKILLS. GUIDEWIRE AND
`CATHETER SKILLS FOR ENDOVASCULAR SURGERY 34 (2nd ed. 2003).
`Littrell, Perry K. “Hemostasis Valve.” U.S. Patent No. 5,176,652
`(1993) (“Littrell”).
`Teitelbaum, George P. “Percutaneously-Inserted Cardiac Valve.”
`U.S. Patent No. 5,332,402 (1994) (“Teitelbaum”).
`Deem, Mark E., et al. “Method and Apparatus for Cardiac Valve
`Repair.” International Patent Application Publication No.
`WO 00/60995 (2000) (“Deem”).
`B. Braun Med., Inc. v. Abbott Labs., 124 F.3d 1419, 1424 (Fed. Cir.
`1997).
`Tiwari, Sarbesh. “Anatomy and Imaging of Coronary Artery Disease
`with Special Reference to CT Coronary Angiography.” Slide 26.
`Excerpt from http://www.slideshare.net/sarbesh1984/anatomy-and-
`imaging-of-coronary-artery-disease-with.
`Kaufman, John A., et al. VASCULAR & INTERVENTIONAL RADIOLOGY.
`THE REQUISITES. 35 (2004).
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`
`
`v
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`Petition for Inter Partes Review of U.S. Patent No. 8,182,530
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`1043 Morgan, J. M., et al. “Left Heart Catheterization by Direct
`Ventricular Puncture: Withstanding the Test of Time.” Catheter
`Cardio Diag, 16:87-90 (1989) (“Morgan”).
`Cata, Ceferino J., et al. “Technique of Apical Left Ventricular
`Puncture Revisited: A Case Report of Double-Valve Prosthesis
`Evaluation.” J Invasive Cardiol, 6(7):251- 255 (1994) (“Cata”),
`
`1044
`
`
`
`vi
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`Petition for Inter Partes Review of U.S. Patent No. 8,182,530
`
`
`I. OVERVIEW OF PETITION
`Edwards Lifesciences Corporation (“Edwards” or “Petitioner”) requests that
`
`the Patent Trial and Appeal Board (the “Board”) institute inter partes review of
`
`claims 1 and 6 of U.S. Patent No. 8,182,530 ( the “‘530 patent”, Ex.
`
`1001) in accordance with 35 U.S.C. §§ 311-319 and 37 C.F.R. § 42.100 et seq.
`
`The claims of the ‘530 patent are unpatentable for at least two reasons:
`
`(i) methods for treating the aortic valve (including aortic valve replacement) using
`
`an approach via an access point at or near the apex of the heart (i.e., transapical)
`
`were well known; and (ii) it would have been obvious during the pertinent time
`
`frame to employ a transapical approach in lieu of a transfemoral or transseptal
`
`approach for implanting an aortic valve prosthesis in the event a transfemoral or
`
`transseptal approach was contraindicated for a patient.
`
`A. Brief Overview of the ‘530 Patent
`
`The ‘530 patent is generally directed to methods of treating a heart using
`
`minimally-invasive surgical procedures. The surgical procedures include entering
`
`the heart through the heart muscle at its left or right ventricular apex (i.e., entering
`
`the heart “transapically”). (Ex. 1001, Abstract) One of these procedures involves
`
`implanting a prosthetic heart valve through an opening created via a cannulated
`
`needle in the ventricular apex.
`
`
`
`
`
`1
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`Edwards Exhibit 1045, pg. 8
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`Petition for Inter Partes Review of U.S. Patent No. 8,182,530
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`Representative claim 1 of the ‘530 patent recites:
`
`1. A method for implanting a heart valve comprising:
`
`(i) accessing a patient’s heart by piercing a myocardium with a
`cannulated needle having a sharp end;
`
`(ii) feeding through the cannulated needle an elongated wire
`configured to conform to a direction of blood flow, the feeding
`continuing such that the wire follows the blood flow until a length of
`the wire extends at least from a ventricular apex of the heart through
`an aortic valve of the heart;
`
`(iii) installing an access device in a wall of the heart, the access device
`having means for preventing bleeding through the access device;
`
`(iv) inserting a valve delivery device through the access device; and
`
`(v) installing the heart valve.
`
`FIG. 4 of the ‘530 patent, reproduced below, purports to illustrate the steps
`
`(i) and (ii) of claim 1 above (i.e., the accessing and feeding steps with the
`
`exception of the “configured to” recitation):
`
`FIG. 4 of the ‘530 Patent (Ex. 1001)
`
`
`
`
`
`2
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`Petition for Inter Partes Review of U.S. Patent No. 8,182,530
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`Specifically, the specification describes the procedure associated with FIG. 4 as
`
`follows:
`
`After accessing the heart muscle via one or more thoracotomies
`described above, an incision is made to pericardium 30 at access site
`32. Next, myocardium 40 is punctured with needle 42 or other
`suitable device to gain access to the inner heart structures (in this case,
`left ventricle 26), as illustrated in FIG. 4. Guidewire 44 is fed into left
`ventricle 26 in antegrade direction 46. Following the direction of
`blood flow, guidewire 44 is advanced through aortic valve 20 and into
`aorta 28. (Ex. 1001, 8:62-9:2)
`
`
`
`The disclosure of the ‘530 patent is fundamentally premised on the notion
`
`that Dr. Christoph Huber, the sole inventor listed on the ‘530 patent, invented a
`
`method of entering the heart through the apex (i.e., a transapical approach) for
`
`performing surgical procedures on the heart. Dr. Huber explains that, by entering
`
`through the apex of the heart, instruments may be moved with the flow of blood
`
`(i.e., advanced in an “antegrade direction” shown above by reference numeral 46)
`
`when performing certain surgical procedures. As stated in Provisional Application
`
`No. 60/615,009, to which the ‘530 patent claims priority: “[t]he invention further
`
`includes a novel access direction called antegrade, meaning going with the blood
`
`flow (downstream) starting inside any of the heart cavity and being advanced from
`
`there into the downstream vasculature like fro [sic] example into the aorta and
`
`further into the iliac of [sic] femoral arteries from the left ventricle.” (Emphasis
`
`
`
`3
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`added.) (Ex. 1003 at 25) The ‘530 patent refers to the antegrade direction as a
`
`“novel access direction”; however, it makes no mention whatsoever of the
`
`numerous others who disclosed prior to the filing of the ‘530 patent: 1) the use of a
`
`transapical approach; and 2) advancement of instruments in an antegrade direction.
`
`In fact, entering the heart through the ventricular apex and movement of
`
`instruments in the antegrade direction were well known more than 20 years before
`
`the filing date of the ‘530 patent.
`
`Thus, Dr. Huber did not invent the transapical approach for entering the
`
`heart. Nor did Dr. Huber invent a method of moving instruments in an antegrade
`
`direction (i.e., with the flow of blood). In fact, as discussed below in more detail,
`
`Dr. Huber is the lead author of an article that cites a 2002 publication by Dr. Alain
`
`Cribier and acknowledges that “Cribier et al. . . . demonstrated that the antegrade
`
`approach to aortic valved stent implantation was feasible.”1 (See Huber, Christoph
`
`H., et al. “Direct-Access Valve Replacement: A Novel Approach for Off-Pump
`
`Valve Implantation Using Valved Stents.” J Am Coll Cardiol, 46(2):366-370, 369
`
`(2005), Ex. 1006)
`
`
`1 Although it is clear that the 2002 Cribier publication is prior art and material to
`examination of the ‘530 patent, Dr. Huber failed to disclose it to the Patent Office
`during prosecution of the ‘530 patent. That being said, Petitioner understands that
`inequitable conduct is not a prescribed basis for an inter partes review challenge.
`
`
`
`4
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`Edwards Exhibit 1045, pg. 11
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`Petition for Inter Partes Review of U.S. Patent No. 8,182,530
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`II. STATE OF THE ART IN THE 2003 TO 2004 TIME FRAME
`A. Known Valve Prosthesis Implantation Techniques Included the
`Antegrade Approach
`
`In 1992, Drs. Andersen, Knudsen, and Hasenkam published an article
`
`describing transcatheter implantation of an aortic valve prosthesis. (See Andersen,
`
`Henning R., et al. “Transluminal Implantation of Artificial Heart Valves.
`
`Description of a New Expandable Aortic Valve and Initial Results with
`
`Implantation by Catheter Technique in Closed Chest Pigs.” Eur Heart J, 13:704-
`
`708 (1992) (“Andersen”), Ex. 1007) Andersen described the doctors’ successful
`
`transluminal implantation of prosthetic heart valves in pigs using a catheterization
`
`technique. (Id. at Abstract) The expandable prosthetic heart valve was mounted
`
`on a balloon catheter. (Id. at 704-705) Implantations were then performed via the
`
`abdominal aorta using a minimally invasive surgical procedure due to limitations
`
`in the diameters of peripheral blood vessels in pigs. (Id. at 706) The goal of these
`
`experiments was to demonstrate the feasibility of prosthetic heart valve
`
`implantation in humans using a catheterization technique and without the need for
`
`open-heart surgery. (Id. at 707-708)
`
`Advancing to the year 2000, a pulmonary valve prosthesis was successfully
`
`implanted in a human using a percutaneous technique and without the need for
`
`open-heart surgery. (See Bonhoeffer, Philipp, et al. “Percutaneous Replacement of
`
`Pulmonary Valve in a Right-Ventricle to Pulmonary-Artery Prosthetic Conduit
`
`
`
`5
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`Edwards Exhibit 1045, pg. 12
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`Petition for Inter Partes Review of U.S. Patent No. 8,182,530
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`with Valve Dysfunction.” Lancet, 356:1403-1405 (2000), Ex. 1008) Bonhoeffer
`
`showed that percutaneous valve replacement in the pulmonary position was
`
`possible, with the technique being applicable for valve replacements in other
`
`cardiac and non-cardiac positions. (Id. at 1403) Using a standard catheterization
`
`technique through the right femoral vein, a guidewire was delivered in the
`
`antegrade direction and positioned in the pulmonary artery. Next, a delivery
`
`system having the valved stent mounted thereon was connected to the guidewire
`
`and advanced into the pulmonary artery. Thereafter, the stent was uncovered and
`
`deployed by balloon inflation in the precise position of the obstruction. The
`
`delivery system was then removed. (Id. at 1404)
`
`Then, in 2002, Dr. Alain Cribier reported that, after performing a balloon
`
`valvuloplasty on the aortic valve, he successfully implanted an aortic valve
`
`prosthesis in a human using a catheterization technique and without requiring
`
`open-heart surgery. During the implantation procedure, the aortic valve was
`
`mounted on a balloon catheter and delivered using an antegrade approach. (See
`
`Cribier, Alain, et al. “Percutaneous Transcatheter Implantation of an Aortic Valve
`
`Prosthesis for Calcific Aortic Stenosis.” Circulation, 106:3006-3008 (2002)
`
`(“Cribier”), Ex. 1009, 3006) As noted above, even Dr. Huber, the sole inventor
`
`listed on the ‘530 patent, acknowledged Cribier’s success in implanting an aortic
`
`valve prosthesis using the antegrade approach.
`
`
`
`6
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`Edwards Exhibit 1045, pg. 13
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`Petition for Inter Partes Review of U.S. Patent No. 8,182,530
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`Likewise, in 2003, Spenser similarly described an antegrade approach for
`
`deploying an implantable prosthetic valve device at the natural aortic valve
`
`position. (See Spenser, Benjamin, et al. “Implantable Prosthetic Valve.” U.S.
`
`Patent Publication No. 2003/0114913 (2003) (“Spenser”), Ex. 1010) Approaching
`
`the aortic valve from the left ventricle after performing a transseptal puncture,
`
`using a guide wire as a guiding tool for guiding a balloon catheter through a
`
`vasculature of the patient, the valve device was mounted over one portion of the
`
`balloon catheter and deployed at the natural aortic valve position. (Id. at ¶¶ [0055]
`
`– [0065])
`
`Also in 2003, Zhou reported an off-bypass implantation of a self-expandable
`
`valved stent in the pulmonary valve position, by accessing the heart through an
`
`incision made on the anterior aspect of the right ventricle, also known as a trans-
`
`ventricular approach. (See Zhou, Jun Qing, et al. “Self-Expandable Valved Stent
`
`of Large Size: Off-Bypass Implantation in Pulmonary Position.” Eur J Cardio-
`
`Thorac Surg, 24:212-216 (2003) (“Zhou”), Ex. 1011, 213) Following an
`
`antegrade approach, a stent-graft delivery system was advanced from the right
`
`ventricle to the pulmonary valve position. (Id.)
`
`Accordingly, it is abundantly clear that delivery of a valve prosthesis, e.g.,
`
`aortic or pulmonary, on a catheter via an antegrade approach was known prior to
`
`the 2003/2004 time frame. Likewise, as will be discussed in further detail below,
`
`
`
`7
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`Edwards Exhibit 1045, pg. 14
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`Petition for Inter Partes Review of U.S. Patent No. 8,182,530
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`entry into the heart through a ventricular apex was also known prior to the
`
`2003/2004 time frame.
`
`B. Treating the Aortic Valve via a Transapical Approach and Crossing
`the Aortic Valve with a Guidewire Were Well Known Techniques
`
`An article published in the mid-1980s in the Journal of Thoracic and
`
`
`
`Cardiovascular Surgery by Dr. Leonard Golding provides an exemplary discussion
`
`of passing a cannula from the apex of the left ventricle across the aortic valve (an
`
`“antegrade” direction) into the proximal ascending aorta in order to achieve a
`
`successful cardiopulmonary bypass. (See Golding, Leonard, A. R. “New
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`Cannulation Technique for the Severely Calcified Ascending Aorta.” J Thorac
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`Cardiovasc Surg, 90(4):626-627, 626 (Oct., 1985) (“Golding”), Ex. 1012)
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`This transapical approach was chosen by Golding instead of the other
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`approaches because severe calcific atherosclerosis involving the femoral arteries,
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`ascending aorta, right subclavian artery, and aortic arch precluded standard
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`cannulation techniques. (Id. at 626) Golding illustrates two important, recurring
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`themes regarding accessing the aorta via the left ventricular apex:
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`(a) direct left ventricular puncture through the apex of the heart for
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`accessing the aorta was known to be a workable route and was commonly
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`used when other approaches (i.e., through the peripheral vasculature) were
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`not accessible; and
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`(b) the presence of severe calcific atherosclerosis in the peripheral
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`arteries had been known for decades to be one of the reasons for accessing
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`the aorta via the transapical approach (thereby avoiding the inaccessible
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`calcified peripheral vasculature).
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`Moreover, numerous other minimally invasive procedures were known to be
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`performed transapically before the earliest filing date of the ‘530 patent. These
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`prior art minimally invasive transapical procedures included (i) preoperative
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`evaluation of the aortic valve, (ii) aortic valvuloplasty using a balloon catheter, and
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`(iii) direct implantation of prosthetic valves.
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`In fact, by the early 1980s, advancing a catheter into the left ventricle by
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`way of transapical puncture was described as a standard technique. For example,
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`in 1981, Wong described a sequence of:
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`(a) accessing the left ventricular cavity by needle puncture in the left
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`ventricular apex,
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`(b) advancing a guidewire through the needle, and
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`(c) advancing an angiographic catheter over the guidewire.
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`(See Wong, C. M., et al. “Percutaneous Left Ventricular Angiography.” Catheter
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`Cardio Diag, 7:425-32 (1981) (“Wong”), Ex. 1013, 426-429) Wong characterized
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`this procedure as:
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`nothing more than a combination of standard transapical puncture
`and standard percutaneous insertion of a catheter over a guidewire.
`(Id. at 429, emphasis added.)
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`Wong explained that the transapical route was chosen when other standard routes
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`for accessing the aortic valve were not feasible for catheterization, i.e., due to
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`vessel size or other constraints. (Id. at 425, 426)
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`Similarly, an article from 1961 explores the transapical route for
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`catheterization of the left side of the heart where it was not possible to gain access
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`through a vein or via retrograde aortic catheterization. (See Lurie, Paul R., et al.
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`“An Apical Technic for Catherization of the Left Side of the Heart Applied to
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`Infants and Children.” New Engl J Med, 264(23):1182-1187 (1961) (“Lurie”), Ex
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`1014, 1182, 1184) In evaluating a suitable replacement method, Lurie mentioned
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`that such a method “must be equally easy in a patient of any size from an infant up,
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`and regardless of the relative size of the heart.” (Id. at 1182) Lurie determined
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`that the transapical route, which “was applied over a one-year period to 20
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`patients” had gratifying results. (Id.)
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`These known techniques for entering the left ventricle through the
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`ventricular apex were not only used to assess the function of the aortic valve, but
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`were also used to treat the aortic valve. For example, the same “standard
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`transapical puncture” and “standard percutaneous insertion of a catheter over a
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`guidewire” disclosed in the Wong article were known steps in balloon aortic
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`valvuloplasty. For example, a 1991 article by Maxwell, et al. described balloon
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`aortic valvuloplasty as follows:
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`The left ventricular apex was entered on the second needle placement.
`A guide wire was entered through the needle and passed easily across
`the aortic valve. After we established that the valve could be crossed
`with the guidewire the wire was withdrawn and the custom made
`balloon catheter was then inserted. It was inflated twice within the
`valve orifice.
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`(See Maxwell, Darryl, et al. “Balloon Dilatation of the Aortic Valve in the Fetus: A
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`Report of Two Cases.” Br Heart J, 65:256-258 (1991) (“Maxwell”), Ex 1015,
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`257)
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`That same year, in 1991, Neish, et al. reported another example where the
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`transapical approach was a known alternative route for performing balloon aortic
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`valvuloplasty:
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`Percutaneous balloon aortic valvuloplasty was attempted in both
`patients. It was impossible to cross the aortic valve with a guidewire
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`from the aorta into the left ventricle in either patient. Therefore,
`balloon valvuloplasty could not be performed in the usual retrograde
`manner. In 1 patient, a guidewire was advanced from the femoral
`vein across the atrial septum into the left ventricle and across the
`aortic valve.
` However, it was impossible to manipulate the
`valvuloplasty catheter across the aortic valve.
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`(See Neish, Steven R., et al. “Intraoperative Balloon Valvuloplasty for Critical
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`Aortic Valvular Stenosis in Neonates.” Am J Cardiol, 68:807- 810 (1991)
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`(“Neish”), Ex 1016, 808-809) Because the retrograde transfemoral and antegrade
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`transseptal routes were unavailable in these procedures, the transapical, antegrade
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`approach was used, as shown in Figure 3 of the Neish article, reproduced below:
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`Figure 3 of the Neish article (Ex. 1016 at 808)
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`
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`The transapical approach to balloon aortic valvuloplasty was again reported
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`in 2004 as a technique to prevent the progression of fetal aortic stenosis to
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`hypoplastic left heart syndrome. (See Tworetzky, Wayne, et al. “Balloon Dilation
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`of Severe Aortic Stenosis in the Fetus: Potential for Prevention of Hypoplastic Left
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`Heart Syndrome Candidate Selection, Technique, and Results of Successful
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`Intervention.” Circulation, 110:2125-2131 (2004) (“Tworetzky”), Ex 1017)
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`Figure 1 of Tworetzky, reproduced below, illustrates a needle extending through
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`the left ventricular apex of a fetus, and a guidewire being passed from the apex of
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`the left ventricle through the aortic valve in the antegrade direction:
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`
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`(Id. at 2127) As again made clear in Tworetzky, using a transapical approach for
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`treating a heart – an infant’s heart in this case – was a logical and obvious choice
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`because the peripheral vasculature was not accessible.
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`
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`Finally, albeit more examples exist, one of the features of Lattouf’s approach
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`is directed to “gaining access to a patient’s heart chamber through the wall of the
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`patient’s heart, such as at the apex thereof, for repairing damaged or otherwise
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`incompetent heart valves.” In addition, Lattouf discloses the use of the transapical
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`approach to perform “aortic stenting for aortic dissections and aneurysm therapy
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`. . .” (See Lattouf, Omar M. “Treatment for Patient with Congestive Heart
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`Failure.” U.S. Patent Application Publication No. 2003/0130571 (2003)
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`(“Lattouf”), Ex. 1005, ¶¶ [0007] - [0008]) The aortic stents are referred to as
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`“endostents” in the procedure graphically illustrated in Provisional Application No.
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`60/340,062, filed on December 8, 2001, to which Lattouf claims priority and
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`incorporates the entire contents by reference:
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`
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`(Ex. 1025 at 4)
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`The procedure described by Lattouf includes piercing the heart wall and
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`accessing the left ventricle at or near the apex of the patient’s heart, installing an
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`access device that prevents loss of blood through the passageway, and advancing a
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`guidewire “through the inner lumen of the needle into the heart chamber and
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`further advanced through the valve to be treated . . .” (Id. at ¶ [0010])
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`C. Guidewires Were Well-Known, Off-the-Shelf Equipment Used to
`Guide Other Equipment/Prostheses
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`By 2004, guidewire design was a highly developed field, with particular
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`tasks calling for specific design considerations. As evidenced by Haase,
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`guidewires that are adapted for passage across a heart valve have a complex
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`construction that typically includes a core wire and distal tip that have different,
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`complementary functions. (See Haase, Karl, et al. “Method and Apparatus for
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`Crossing a Heart Valve.” U.S. Patent Application Publication No. 2004/0153135
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`(2004