IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________
`
`EDWARDS LIFESCIENCES CORPORATION,
`
`Petitioner,
`
`v.
`
`ENDOHEART AG
`
`Patent Owner.
`
`__________________
`
`IPR2016-00299
`
`U.S. Patent No. 8,182,530
`
`__________________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`
`
`

`
`
`
`
`
`
`
`III.
`
`TABLE OF CONTENTS
`I.
`Introduction ............................................................................................... 1
`II.
`Technological Background ........................................................................ 1
` Antegrade And Retrograde .................................................................... 1
`Aortic Stenosis ...................................................................................... 2
`
`Seldinger, 1952: Introduction Of A "Lead" Into The Circulatory
`System ................................................................................................... 3
`The '530 Patent .......................................................................................... 5
` Overview ............................................................................................... 5
`Claims .................................................................................................... 6
`
`Specification Teaches A Practical Distinction Between Guidewires
`With Two Distinct Performances .......................................................... 7
`Prosecution History Shows the Differences Between The ‘530 Patent
`And Lattouf .........................................................................................10
`Claim Construction ..................................................................................12
`"Configured To Conform To A Direction Of Blood Flow" (Claims 1
`And 6) ..................................................................................................12
`Petitioner’s Implicit Construction Is Flawed Because It Incorrectly
`Reads The Term Out Of The Claims ..................................................12
`Patent Owner’s Proposed Construction Is Correct .............................13
`
` Other Claim Terms In The Petition Are Not Material At This Time .15
`The Petition Should Be Denied Under § 325(D) ....................................16
`The Examiner Considered Both Bergheim and Lattouf In The Same
`Office Action .......................................................................................16
`Bergheim And Lattouf Are Factually Redundant As They Have
`Already Been Considered By The Office ...........................................17
`Bergheim is not prior art because it describes Huber’s Own Work ........17
`Bergheim is not prior art because it is Antedated ...................................27
`Petitioner’s Arguments Against The Huber Declaration Lack Merit .28
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IV.
`
`V.
`
`VI.
`VII.
`
`
`
`i
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`

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`
`
`
`
`
`
`Additional Evidence Confirms That Bergheim Was Properly
`Antedated .............................................................................................30
`Ground 1 fails to demonstrate a reasonable likelihood of
`VIII.
`unpatentability .........................................................................................................39
`Petitioner Has Not Addressed How The Prior Art Meets Elements 1c
`
`And 6c Beyond Merely Disclosing An Antegrade Approach ............39
`Elements 1c And 6c Are Not Necessarily Present In The Prior Art To
`Meet The High Standard For Inherency ..............................................46
`Real Party-In-Interest ..............................................................................51
`Conclusion ...............................................................................................54
`
`IX.
`X.
`
`
`
`ii
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`

`
`
`
`Preliminary Response to Petition for Inter Partes Review
`
`of U.S. Patent No. 8,182,530
`
`LIST OF EXHIBITS
`
`Exhibit
`No.
`2001 Seldinger, Sven, I. "Catheter Replacement of the Needle in
`Percutaneous Arteriography." Acta Radiologica, 39(5): 368-
`376 (1952) ("Seldinger").
`2002 Pitta, Sridevi, R. "Complications Associated with Left
`Ventricular Puncture." Catheterization and Cardiovascular
`Interventions, 76:993–997 (2010) ("Pita")
`2003 Levy, Morris, J. and Lillehei, C. Walton " Percutaneous
`Direct Cardiac Catheterization — A New Method, with
`Results in 122 Patients." N Engl J Med, 271.6: 273-280
`(Aug, 1964) ("Levy and Lillehei").
`2004 Defendant Edwards Lifesciences Corporation’s Opening
`Claim Construction Brief in Endoheart AG, v. Edwards
`Lifesciences Corporation, Case No. 1:14-cv-1473 LPS-CJB
`in the United States District Court for the District of
`Delaware.
`2005 Excerpt from Deposition Transcript of Christoph H. Huber
`(January 27, 2016) in the US District Court for the District
`of Delaware (“1/27/16 Huber Dep. Tr.”)
`Instructions For Use - Edwards SAPIEN Transcatheter
`Heart Valve With The Ascendra Balloon Catheter
`2007 Emilio R. Giuliani et al., Cardiology: Fundamentals and
`Practice 1516-1517 (2d ed., Mosby-Year Book, Inc., St.
`Louis Missouri 1991) (“Giuliani”)
`2008 Assignment of U.S. Patent Application No. 10831770 From
`Bergheim to 3F Therapeutics Inc. (November 1, 2004).
`2009 Assignment of U.S. Patent Application No. 10831770 from
`3F Therapeutics Inc. to Medtronic 3F Therapeutics Inc.
`(March 26, 2012)
`2010 Definition of “Configured”, Collins English Dictionary -
`Complete & Unabridged 2012 Digital Edition
`
`2006
`
`
`
`iii
`
`

`
`
`
`2011 Notice regarding the serve of subpoenas to Rodolfo C.
`Quijano in the United States District Court for the District
`of Delaware
`2012 Letter from Dr. Rodolfo C. Quijano to William O'Hare,
`Snell & Wilmer.
`2013 E-mail from Dr. Rodolfo C. Quijano to Christoph Huber
`(October 6, 2006)
`2014 E-mail from Dr. Rodolfo C. Quijano to Christoph Huber
`(April 19, 2006)
`2015 Presentation of the Lecture “New Tools for New Goals” in
`Scottsdale, Arizona at the ISCS Convention (February
`2004)
`2016 Excerpt from Deposition Transcript of Christoph H. Huber
`(January 29, 2016) in the US District Court for the District
`of Delaware (“1/29/16 Huber Dep. Tr.”)
`2017 Cardima Inc., Notice of Annual Shareholders Meeting (May
`19, 2005)
`2018 Excerpt from the History File of Bergheim U.S. Patent
`Application Publication No. 2005/0240200.
`2019 Press Release – Percutaneous Valve Technologies, Inc. was
`acquired by Edwards Lifesciences Inc.
`2020 List of Assignments From Percutaneous Valve
`Technologies, Inc. To Edwards Lifesciences PVT, Inc.
`2021 List of U.S. Patents That Names Alain Cribier As An
`Inventor Or Co-Inventor
`2022 List Of Entities Wholly Owned By Edwards Lifesciences
`Corporation
`2023 Lists of Patents owned by Edwards Lifesciences
`Corporation and Edwards Lifesciences LLC
`2024 Edwards Lifesciences’ Answer And Counterclaims in the
`United States District Court for the District of Delaware.
`2025 French Catheter Scale – Wikipedia Website
`2026 Needle Gauge Comparison Chart - Wikipedia Website
`2027
`Jamieson, W.R.E., et. al. “Antegrade Placement of the
`Aortic Valve Stent: Transventricular Delivery With the
`ENTRATA™ System.” Euro Intervention Supplements
`1(A): 14A-18A (2006) (“Jamieson”)
`2028 Cribier, Alain, et al. “Early Experience With Percutaneous
`Transcatheter Implantation of Heart Valve Prosthesis for the
`iv
`
`
`
`

`
`
`
`2029
`
`
`
`
`
`Treatment of End-Stage Inoperable Patients With Calcific
`Aortic Stenosis.” JACC, 43(4):698-703 (2004) (“Cribier
`2004”).
`Press Release – “Edwards Lifesciences Delays
`Percutaneous Aortic Heart Valve Clinical Trials to
`Incorporate New Delivery System” (June, 2005)
`2030 Vassiliades, Thomas, A., et al. “The Clinical Development
`of Percutaneous Heart Valve Technology, A Position
`Statement of the Society of Thoracic Surgeons (STS), the
`American Association for Thoracic Surgery (AATS), and
`the Society for Cardiovascular Angiography and
`Interventions (SCAI) Endorsed by the American College
`of Cardiology Foundation (ACCF)” JACC, 45(9):1554-
`1560 (May, 2005) (“Vassiliades”).
`2031 Walther, Thomas, et al. “Trans Catheter Aortic Valve
`Implantation: Surgical Perspective.” Archives of
`Cardiovascular Diseases, 105(3):174-180 (2012)
`(“Walther”)
`2032 Press Release - Edwards Unveils Ascendra Aortic Heart
`Valve Replacement System
`2033 Walther, Thomas & Mohr Frriedrich W., “Editorial, Aortic
`Valve Surgery: Time to be Open-Minded and to Rethink"
`European Journal of Cardio-thoracic Surgery, 31: 4-6
`(2007) (“Walther & Mohr”)
`2034 Walther, Thomas, et al. “Minimally Invasive Transapical
`Beating Heart Aortic Valve Implantation — Proof of
`Concept”, European Journal of Cardio-thoracic Surgery,
`31: 9-15 (2007) (“Walther et. al.”)
`2035 Huber, Christoph, H. "Direct-Access Valve Replacement: A
`Novel Approach For Off-Pump Valve Implantation Using
`Valved Stents." JACC, 46.2: 366-370 (2005). (“Huber”)
`2036 Dewey, Todd, M., et al. "Transapical aortic valve
`implantation: an animal feasibility study." Ann Thorac.
`Surg, 82.1: 110-116 (2006). (“Dewey”)
`2037 Boudjemline, Younes, & Bonhoeffer, Philipp. "Steps toward
`percutaneous aortic valve replacement." Circulation 105.6:
`775-778 (2002). (“Boudjemline & Bonhoeffer”)
`
`
`
`v
`
`

`
`
`
`2038 Cribier, Alain. “Valve Prosthesis For Implantation In Body
`Channels”.” U.S. Patent Application Publication No.
`2005/0251251 (“Cribier 2005”).
`2039 Cribier, Alain. “Valve Prosthesis For Implantation In Body
`Channels”.” U.S. Patent Application Publication No.
`2003/0014104 (“Cribier 2003”).
`2040 A Redline Comparison Between U.S. Patent Application
`Publication No. 2003/0014104 ,Cribier 2003 and U.S.
`Patent Application Publication No. 2005/0251251, Cribier
`2005.
`
`
`
`
`
`vi
`
`

`
`I.
`
`INTRODUCTION
`
`
`
`Endoheart AG (“Patent Owner”) submits this Preliminary Response to the
`
`Petition filed by Edwards Lifesciences Corporation (“Edwards Corporation” or
`
`“Petitioner”). Patent Owner demonstrates below that Petitioner has incorrectly
`
`construed claims, relied upon redundant references, improperly relied upon a
`
`reference that was derived from Dr. Huber, inventor of the ‘530 Patent, improperly
`
`relied upon an antedated reference and failed to state grounds that show or suggest
`
`all the elements of the properly construed claims and upon which a trial can be
`
`instituted under 37 C.F.R. § 42.108. For at least the foregoing reasons, which are
`
`set forth below after a brief discussion of technical background and the ‘530
`
`Patent, the Petition should be denied.
`
`II. TECHNOLOGICAL BACKGROUND
`
` Antegrade And
`Retrograde
`
`"Antegrade" and "retrograde"
`
`are directions that are defined
`
`relative to a direction of blood flow.
`
`The directions are shown for the
`
`aortic and mitral annuli in
`
`Schematic A, rendered by Patent
`
`Owner, at right. Valve leaflets,
`
`
`
`1
`
`

`
`
`
`which would be present in the different valve annuli, for the purpose of simplicity,
`
`are not shown. In nature, the left ventricular valves alternate opening, so that only
`
`the mitral valve is open during filling ("diastole") and only the aortic valve is open
`
`during ejection ("systole"), which is driven be contraction of the ventricles.
`
`In an antegrade valve delivery, the valve is delivered in the direction of the
`
`blood flow. In a retrograde valve delivery, the valve is delivered opposite the
`
`direction of the blood flow. A long instrument, such as a guide wire, that travels
`
`along numerous blood vessels, may have antegrade portions and retrograde
`
`portions.
`
` Aortic Stenosis
`
`In aortic stenosis, the aortic valve leaflets become calcified. The maximum
`
`valve opening is reduced, as shown here in
`
`Schematic B, rendered by Patent Owner. This can
`
`interfere with ejection of blood from the left
`
`ventricle and thus cause left ventricular systolic
`
`pressure to increase significantly. The shape and
`
`location of the orifice of a stenosed aortic valve can be irregular. This often makes
`
`navigation and through-passage of rigid instrumentation difficult and dangerous.
`
`
`
`2
`
`

`
`
`
`Mitral valve pathologies generally interfere with ventricular filling during
`
`diastole and blood retention during systole. Mitral valve pathologies can therefore
`
`lead to decreased left ventricular systolic pressure.
`
`
`
`Seldinger, 1952: Introduction Of A "Lead" Into The Circulatory
`System
`
`Schematic C, at left, is a rendering by the Patent Owner that schematically
`
`shows Seldinger's approach for introduction of contrast agent—at a distance from
`
`the vascular access point—in internal organs by
`
`insertion of a catheter into an artery at the access point.
`
`This enabled Seldinger to advance the catheter "up" (and
`
`therefore against the flow—"retrograde") to various
`
`internal organs for delivery of the contrast agent for
`
`radiography. Ex. 2001, Seldinger; see esp. id. at 371
`
`("catheter is usually pushed 'up' the vessel without
`
`difficulty…").
`
`Ninety-five percent of Seldinger's reported
`
`procedures can be inferred to be retrograde. (Id. at 373 (reporting 40 arterial
`
`catheterizations that included 35 aortographies via the femoral artery, 3 subclavian
`
`arteriographies by means of puncture of the brachial artery in the antecubital fossa,
`
`and 2 catheterizations of the femoral artery in a distal direction).)
`
`Seldinger taught, in relevant part, that:
`3
`
`
`
`

`
`
`
`1. The tip of a flexible round-end "metal leader" with increased flexibility of its
`
`distal 3 cm is inserted "a very short distance into the lumen of the artery through
`
`the needle." (Id. at 370.);
`
`2. The needle is removed, leaving the leader in place; pressure should be
`
`placed proximal the puncture site to control bleeding, because the puncture is
`
`wider than the leader (Id. at 371.);
`
`3. The catheter is threaded onto the leader;
`
`4. The catheter and the leader are pushed just far enough to ensure that the tip
`
`of the catheter is in the lumen of the vessel;
`
`5. The leader is removed and the catheter is "directed" to the level required.
`
`The unsupported catheter is "usually pushed up the vessel without difficulty…"
`
`(Id.) (emphasis added). Thus, the Seldinger technique was originally reported
`
`mainly for retrograde entry into blood vessels, but Seldinger himself reported using
`
`it in the antegrade or "distal" direction. (Id. at 373)
`
`
`
`4
`
`

`
`
`
`III. THE '530 PATENT
`
` Overview
`
`The '530 Patent (Ex. 1001) discloses apparatus and methods for providing
`
`replacement heart valves, particularly replacement aortic valves. Figure 14 of the
`
`'530 patent, at right (Ex.
`
`1001 at 11), shows
`
`compressed heart valve 140
`
`being delivered to aortic
`
`valve rim 141 through left
`
`ventricle 26 by valve
`
`delivery device 142. Valve
`
`delivery device 142 runs
`
`along catheter 66, which
`
`extends through aortic valve rim 141 into the aorta. Elements 90, 92, and 94 are
`
`embolic protection devices. Element 60 is an access device. (Ex. 1001, 14:48-61.)
`
`Guidewire 66, which is a stiff guidewire for supporting the introduction of valve
`
`140 is emplaced through a guidewire exchange that is initiated by the introduction
`
`of a thin and flexible guidewire. (Id., 9:10-20.) As will be discussed below, the
`
`use of the thin and flexible guidewire in the left ventricle is patentable over the use
`
`of prior stiff guidewires.
`
`
`
`5
`
`

`
`
`
` Claims
`
`Petitioner challenges claims 1 and 6.
`
`Claim 1 recites, with elements enumerated as set forth by Petitioner:
`
`(a)
`
`(b)
`
`A method for implanting a heart valve comprising:
`
`accessing a patient's heart by piercing a myocardium with a
`
`cannulated needle having a sharp end;
`
`(c)
`
`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;
`
`(d)
`
`(e)
`
`installing an access device in a wall of the heart,
`
`the access device having means for preventing bleeding through the
`
`access device;
`
`(f)
`
`(g)
`
`inserting a valve delivery device through the access device; and
`
`installing the heart valve.
`
`Claim 6 recites, with elements enumerated as set forth by Petitioner:
`
`(a)
`
`(b)
`
`A method of operating on a patient comprising:
`
`accessing the patient's heart by piercing a myocardium at a ventricular
`
`apex of the heart with a cannulated needle having a sharp end;
`
`
`
`6
`
`

`
`
`
`(c)
`
`feeding through the cannulated needle an elongated wire having a
`
`length along which the wire is configured to conform to a direction of blood flow,
`
`the feeding directed by the blood flow such that the wire follows the blood flow,
`
`the feeding continuing until the length extends at least from the ventricular apex to
`
`an aorta;
`
`(d)
`
`(e)
`
`installing an access device in a wall of the heart,
`
`the access device having means for preventing bleeding through the
`
`access device; and
`
`(f)
`
`performing a surgical procedure of implanting a heart valve.
`
`Patent Owner sets forth below reasons that petitioner's ground 1 fails to
`
`demonstrate a reasonable likelihood that claims 1 and 6 are unpatentable. Patent
`
`Owner focuses on Elements 1c and 6c, above, and reserves the right if necessary to
`
`provide reasons based on other Elements that petitioner's ground 1 fails to
`
`demonstrate a reasonable likelihood that claims 1 and 6 are unpatentable.
`
`
`
`Specification Teaches A Practical Distinction Between Guidewires
`With Two Distinct Performances
`
`Huber FIGS. 4-6 (Ex. 1001 at 5-6), reproduced below, illustrate exchange of
`
`guidewire 44 with guidewire 66.
`
`Guidewire 44 is advanced from the apex into the aorta following the direction
`
`of blood flow. (Id., 9: 1-2.) Huber teaches that guidewire 44 may be further
`
`advanced into the arteries. Huber teaches that a wire with a snare loop may be
`7
`
`
`
`

`
`
`
`advanced retrograde to capture guidewire
`
`44. Neither the further advancement,
`
`antegrade, of guidewire 44 through the
`
`arteries, nor the advancement, retrograde,
`
`of the snaring wire is an advancement that
`
`"follows" the blood flow. (Id., 9: 3-9.)
`
`What is common between the further advancement of guidewire 44 and the
`
`advancement of the snaring wire is that their trajectory—whether antegrade or
`
`retrograde—is that both are advancements following the lumen in which they
`
`travel. Only the advancement across the ventricle is an advancement "following
`
`the blood flow."
`
`Guidewire 44 is then replaced with guidewire 66 by placing catheter 50 over
`
`guidewire 44, removing guidewire 44 from catheter, and inserting guidewire 66.
`
`
`
`8
`
`

`
`
`
`Guidewire 44 is not sturdy enough to support the transportation of surgical
`
`tools. (Id., 9: 10-13 ("Guidewire 44 may be a relatively thin and flexible
`
`guidewire.").) Guidewire 66 is capable of bearing the tools. (Id., 9:10-13 (" In
`
`order to provide sturdier support for the exchange of surgical tools, it may be
`
`desirable to replace guidewire 44 with a stiffer guidewire."); FIG. 6, id. at 6
`
`(showing access device 60 having been slided along guidewire 66); Id.,9: 51-52
`
`("Next, a dilator (not shown) may be advanced over stiffer guidewire 66 (FIG. 6));
`
`12: 18-22 ("Additionally, some embodiments of the present invention may include
`
`the use of a percutaneously placed small caliber 20 blood pump containing an
`
`impellor (e.g., a VAD (Ventricular Assist Device)). The VAD may be inserted in a
`
`retrograde or in an antegrade direction over guidewire 66."); 14:59-60 ("Coaxial
`
`catheters 111 and 112 can be advanced over guidewire 66 and passed through
`
`valve 63 of access device 60."); and 12:51-53 ("Valve delivery device 142 is
`
`advanced along guidewire 66.").)
`
`Because guidewire 44 is relatively "thin and flexible" and follows the blood
`
`flow, and guidewire 66 is sturdier and is not specified to follow the blood flow,
`
`Huber illustrates the distinction between a wire that is configured to conform to the
`
`blood flow and a wire that is not.
`
`
`
`9
`
`

`
`
`
`
`
`Prosecution History Shows the Differences Between The ‘530
`Patent And Lattouf
`
`New claims including the term "configured to conform to a direction of blood
`
`flow" on June 3, 2011 (Reply to Office Action, Ex. 1002 at 112) were added after
`
`the Examiner issued rejections over Seguin in combination with Lattouf (Id. at
`
`133). The Examiner sustained the rejections in a June 27, 2011, Office action (Id.
`
`at 60). At a September 16, 2011, interview with Examiners Mashack and Woo,
`
`amendments of the claims were agreed upon that led to the allowance of the
`
`claims. Issued claims 1 and 6 correspond to prosecuted claims 7 and 1,
`
`respectively.
`
`1.
`
`Claims 1 and 6 distinguish, in terms of use, between
`Huber's guidewire and Lattouf's guidewire
`
`As required by the Examiner (Ex. 1002 at 44), a distinction between the
`
`claimed guidewire and the Lattouf guidewire was expressed, after amendment, in
`
`terms of "method claim phraseology." The amendment thus required that the wire
`
`be fed in a way that produced an outcome that reflected the physical properties,
`
`viz., "such that the wire follows the blood flow." Prior to the amendment,
`
`however, the distinction was not, for the Examiner, at least, articulated sufficiently
`
`in a method claim phraseology. That perceived insufficiency was remedied by
`
`adding the qualification of the feeding: "such that the wire follows the blood flow."
`
`
`
`10
`
`

`
`
`
`2.
`
`The Examiner recognized the distinction—and deemed its
`role in the claimed methods to be nonobvious
`
`Applicant first amended claims 1 and 6 to include feeding through a needle
`
`wire "configured to conform" to a direction of blood flow in a June 3, 2011
`
`amendment. Ex 1002 at 87. The Examiner stated that Lattouf teaches advancing a
`
`guide wire and that "A guide wire is known to be floppy and would be capable of
`
`conforming to blood flow." Id. at 63. Applicant requested an interview to argue
`
`that Seguin and Lattouf do not render obvious the claimed "feeding of a length of
`
`flow-conforming wire from a ventricular apex to an aorta…" Id. at 58. At the
`
`interview, the Examiner "proposed amending the claims to express allowable
`
`subject matter in method claim phraseology." Id. at 44. The interview led to an
`
`amendment that qualified the claimed feeding "such that the wire follows the blood
`
`flow." Id. at 36-37. The claimed feeding was thus amended to become a feeding
`
`in which the wire follows the blood flow.
`
`Post-interview amendments elucidated the distinction between the performance
`
`of the claimed guide wire and the performance of the Lattouf guidewire. Id. at 45,
`
`e.g. (stating that the claim previously required feeding wire "configured to
`
`conform" to a direction of blood flow and that the Lattouf guidewire is configured
`
`for advancement "against" the direction of blood flow).
`
`Based on the Examiner's requirement to express the non-obvious claim feature
`
`as a method (as opposed to an apparatus qualifier), the applicant amended the
`11
`
`
`
`

`
`
`
`claims—in the very language that the Examiner recorded in the Examiner's
`
`interview summary (Id. at 33)—to qualify the feeding, as a feeding "such that the
`
`wire follows the blood flow." The amendment thus expressed the wire
`
`performance in terms of an outcome of feeding the guidewire—an outcome that
`
`Lattouf's teachings contradicted. Id. at 45. The Examiner then allowed claims.
`
`IV. CLAIM CONSTRUCTION
`
`
`
`"Configured To Conform To A Direction Of Blood Flow" (Claims
`1 And 6)
`
`The only term that warrants construction at this time is “configured to conform
`
`to a direction of blood flow,” which appears in both Claims 1 and 6. Petitioner did
`
`not offer an explicit construction of this term but did implicitly construe the term in
`
`its claim charts (Pet. 50, 54) and expert declaration (Ex. 1026, ¶ 79). However, as
`
`explained below, Petitioner’s implicit construction is incorrect. The proper
`
`construction of the term that the Board should adopt is “having the property or
`
`structure for adapting to the direction of blood flow.”
`
`
`
`Petitioner’s Implicit Construction Is Flawed Because It
`Incorrectly Reads The Term Out Of The Claims
`
`In its claim charts and declaration, Petitioner improperly equates the term
`
`“configured to conform to a direction of blood flow” with “antegrade direction.”
`
`In its ’300 Petition claim charts, Petitioner literally equates (using “i.e.” = “that is”)
`
`“guidewires conforming configured to a direction of blood flow” with “antegrade
`
`
`
`12
`
`

`
`
`
`direction.” IPR2016-00300, Paper 2 at 42, 45 (Dec. 9, 2015). This portion of the
`
`claim chart in the ‘300 Petition refers to paragraph 76 of the Garrett Declaration,
`
`which posits that “the guidewire must necessarily conform to the direction of
`
`blood flow” merely because “access [is] being made from the apex of the left
`
`ventricle to the aortic annulus.” IPR2016-00300, Ex. 1026, ¶ 76 (Dec. 9, 2016)
`
`(emphasis added).
`
`Petitioner’s implicit construction is incorrect, however, because it ignores and
`
`gives no effect to the language “configured to conform.” A rigid, inflexible stick
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`could be advanced in the “antegrade direction” but the stick is not “configured to
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`conform” to a direction of blood flow. Moreover, other language in Claims 1 and
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`6 already requires the wire to extend “from a ventricular apex of the heart through
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`an aortic valve of the heart,” which is an antegrade direction. This other language
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`in the claim would be superfluous if, under Petitioner’s implied construction,
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`“configured to conform to a direction of blood flow” simply means an “antegrade
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`direction.”
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`Patent Owner’s Proposed Construction Is Correct
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`Patent Owner’s proposed construction is correct because it is consistent with
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`the plain and ordinary language of the words in the claims, as confirmed by the
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`specification and prosecution history. The ordinary meaning of “configured” is
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`having a property or structure for achieving something. The ordinary meaning of
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`“conform to” is adapting to.
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`
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`The specification explains that guidewire 44 is “relatively thin and flexible,”
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`which is an example of a property and structure that enables the wire to adapt to
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`the direction of blood flow, i.e., “following the direction of blood flow”. Ex. 1001,
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`8:67-9:2; 9:10-11. Guidewire 44, however, is not sturdy enough to support the
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`transportation of surgical tools. By contrast, guidewire 66 is “stiffer” and
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`“sturdier” and thus capable of bearing surgical tools. Id., 9:10-13 (“In order to
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`provide sturdier support for the exchange of surgical tools, it may be desirable to
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`replace guidewire 44 with a stiffer guidewire.”); 9: 51-52 (“Next, a dilator (not
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`shown) may be advanced over stiffer guidewire 66 (FIG. 6)”); 12: 51-53 (“Valve
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`delivery device 142 is advanced along guidewire 66.”).
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`The prosecution history likewise confirms that this phrase means having the
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`property or structure for adapting to the direction of blood flow. As the Examiner
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`recognized in the June 27, 2011 Office Action in rejecting the claims over the prior
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`art: “A guide wire is known to be floppy and would be capable of conforming to
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`blood flow.” Ex. 1002 at 63. Consistent with the Examiner’s statement, Dr. Huber
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`demonstrated at the October 12, 2011 Interview that a soft guidewire is configured
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`to conform to the direction of blood flow, in contrast to a stiff guidewire, which
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`does not conform to the direction of blood flow. Dr. Huber showed the Examiners
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`a video of the behavior of both types of guidewires when placed in a fluid stream.
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`(Ex. 1002 at 44) The soft guidewire adapted to the direction of the flow by
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`bending in the direction of the flow, whereas the stiff guidewire did not. Dr. Huber
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`also showed the Examiners a second video in which a soft guidewire followed the
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`blood flow in the heart from the left ventricle into the aorta. After seeing these
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`videos, the Examiners noted that the claims of the ‘530 patent would be patentable
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`over the prior art if limitations were added concerning “the wire follows the blood
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`flow.” Ex. 1002 at 33. The Examiners’ proposed language was added to Claim 1
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`and to Claim 6 (id. at 36-37), and those claim were allowed. Id. at 14.
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`The dictionary definition of “configured” confirms that Patent Owner’s
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`construction is correct: “To design or adapt to form a specific configuration or for
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`some specific purpose” (Ex. 2010; emphasis supplied). Here, the wire becomes
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`shaped by the blood flow to achieve the anatomical curvature (a specific
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`configuration) necessary to accomplish the goal of entering the aorta (a specific
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`purpose). That goal requires a material shaping of the wire by the blood flow.
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` Other Claim Terms In The Petition Are Not Material At This
`Time
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`Because Petitioner’s proposed grounds of rejection fail even under Petitioner’s
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`proposed constructions set forth in the Petition, Patent Owner does not find it
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`necessary at this time to comment on Petitioner's proposed constructions and
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`reserves the right to do so if necessitated at a later date.
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`V. THE PETITION SHOULD BE DENIED UNDER § 325(D)
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` The Examiner Considered Both Bergheim and Lattouf In The
`Same Office Action
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`During prosecution of the application that issued as the ’530 patent, the
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`Examiner cited both Bergheim and Lattouf in the same Office action rejecting all
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`pending claims. Ex. 1002 at 206-207. The Examiner cited Bergheim as an
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`anticipatory reference under 35 U.S.C. § 102(e), (id. at 206), and cited Lattouf as
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`“disclosing related limitations of the applicant’s claimed and disclosed invention.”
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`Id. at 207. In response to that rejection, applicant filed the Huber Declaration
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`under Rule 1.131 establishing a prior conception date and diligence. Id. at 198-
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`199. Applicant also amended independent claim 1. Id. at 184. Thereafter, the
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`Office never again raised Bergheim in a rejection.
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`Regarding the Examiner’s removal of Bergheim as a reference, the Petition
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`states: “This is a puzzling result considering that the declaration did not include
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`any corroborating or supporting evidence.” Pet. 28. However, Office policy
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`governing Rule 1.131 declarations states that “averments made in a 37 CFR
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`1.131(a) affidavit or declaration do not require corroboration; an applicant may
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`stand on his or her own affidavit or declaration if he or she so elects.” MPEP
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`§ 715.07 (citing Ex parte Hook, 102 USPQ 130 (Bd. App. 1953)) (emphasis
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`added). Accordingly, Patent Owner’s traversal of the Bergheim rejection, in which
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`Lattouf was also cited, fit entirely within Office policy, without presenting
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`evidence to contradict the declaration that was submitted during prosecution.
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`
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`Bergheim And Lattouf Are Factually Redundant As They Have
`Already Been Considered By The Office
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`Petitioner relies on the “same prior art” as the Examiner affirmatively relied
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`upon in a non-final rejection, and offers no new evidence or binding legal authority
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`that contradicts the Huber Declaration or Office policy that Rule 1.131 declarations
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`submitted during prosecution do not require corroboration. Therefore, the Board
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`should deny the petition under 35 U.S.C. § 325(d). Otherwise, the Board would
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`encourage a flood of IPR petitions by anyone who simply wishes to disagree with
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`an Examiner’s reliance on that Office policy.
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`VI. BERGHEIM IS NOT PRIOR ART BECAUSE IT DESCRIBES
`HUBER’S OWN WORK
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`Petitioner asserts Bergheim as prior art only under pre-AIA § 102(e). See Pet.
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`24. Pre-AIA § 102(e) “explicitly states that the reference at issue must be ‘by
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`another.’” Riverwood Int’l Corp. v. R. A. Jones & Co., 324 F.3d 1346, 1355 (Fed.
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`Cir. 2003) (quoting 35 U.S.C. § 102(e)). “The fact that an application has named a
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`different inventive entity than a patent does not necessarily make that patent prior
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`art.” Applied Materials, Inc. v. Gemini Res. Corp., 835 F.2d 279, 281 (Fed. Cir.
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`1987).) “An applicant may … overcome a reference by showing that the relevant
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`disclosure is a description of the applicant’s own work.” In re Costello, 717 F.2d
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`1346, 1349 (Fed. Cir. 1983) (emphasis added). For example, “[w]hen the 102(e)
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`reference patentee got knowledge of the applicant’s invention from him, as by
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`being associated with him, . . . and thereafter describes it, he necessarily files the
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`application after the applicant’s invention date and the patent as a ‘reference’ does
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`not evidence that the invention, when made, was alre