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

i

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

III. 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

IV. 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

V. 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

VI. Bergheim is not prior art because it describes Huber’s Own Work ........17

VII. Bergheim is not prior art because it is Antedated ...................................27

Petitioner’s Arguments Against The Huber Declaration Lack Merit .28

ii

Additional Evidence Confirms That Bergheim Was Properly Antedated .............................................................................................30

VIII. Ground 1 fails to demonstrate a reasonable likelihood of 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

IX. Real Party-In-Interest ..............................................................................51

X. Conclusion ...............................................................................................54

iii

Preliminary Response to Petition for Inter Partes Review

of U.S. Patent No. 8,182,530

LIST OF EXHIBITS

No. Exhibit 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.”)

2006 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

iv

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

v

Treatment of End-Stage Inoperable Patients With Calcific Aortic Stenosis.” JACC, 43(4):698-703 (2004) (“Cribier 2004”).

2029 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”)

vi

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.

1

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,

2

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.

3

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:

4

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)

5

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.

6

Claims

Petitioner challenges claims 1 and 6.

Claim 1 recites, with elements enumerated as set forth by Petitioner:

(a) A method for implanting a heart valve comprising:

(b) 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) installing an access device in a wall of the heart,

(e) the access device having means for preventing bleeding through the

access device;

(f) inserting a valve delivery device through the access device; and

(g) installing the heart valve.

Claim 6 recites, with elements enumerated as set forth by Petitioner:

(a) A method of operating on a patient comprising:

(b) accessing the patient's heart by piercing a myocardium at a ventricular

apex of the heart with a cannulated needle having a sharp end;

7

(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) installing an access device in a wall of the heart,

(e) 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

8

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.

9

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.

10

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."

11

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

12

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

13

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

could be advanced in the “antegrade direction” but the stick is not “configured to

conform” to a direction of blood flow. Moreover, other language in Claims 1 and

6 already requires the wire to extend “from a ventricular apex of the heart through

an aortic valve of the heart,” which is an antegrade direction. This other language

in the claim would be superfluous if, under Petitioner’s implied construction,

“configured to conform to a direction of blood flow” simply means an “antegrade

direction.”

Patent Owner’s Proposed Construction Is Correct

Patent Owner’s proposed construction is correct because it is consistent with

the plain and ordinary language of the words in the claims, as confirmed by the

specification and prosecution history. The ordinary meaning of “configured” is

having a property or structure for achieving something. The ordinary meaning of

14

“conform to” is adapting to.

The specification explains that guidewire 44 is “relatively thin and flexible,”

which is an example of a property and structure that enables the wire to adapt to

the direction of blood flow, i.e., “following the direction of blood flow”. Ex. 1001,

8:67-9:2; 9:10-11. Guidewire 44, however, is not sturdy enough to support the

transportation of surgical tools. By contrast, guidewire 66 is “stiffer” and

“sturdier” and thus capable of bearing surgical 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.”); 9: 51-52 (“Next, a dilator (not

shown) may be advanced over stiffer guidewire 66 (FIG. 6)”); 12: 51-53 (“Valve

delivery device 142 is advanced along guidewire 66.”).

The prosecution history likewise confirms that this phrase means having the

property or structure for adapting to the direction of blood flow. As the Examiner

recognized in the June 27, 2011 Office Action in rejecting the claims over the prior

art: “A guide wire is known to be floppy and would be capable of conforming to

blood flow.” Ex. 1002 at 63. Consistent with the Examiner’s statement, Dr. Huber

demonstrated at the October 12, 2011 Interview that a soft guidewire is configured

to conform to the direction of blood flow, in contrast to a stiff guidewire, which

does not conform to the direction of blood flow. Dr. Huber showed the Examiners

a video of the behavior of both types of guidewires when placed in a fluid stream.

15

(Ex. 1002 at 44) The soft guidewire adapted to the direction of the flow by

bending in the direction of the flow, whereas the stiff guidewire did not. Dr. Huber

also showed the Examiners a second video in which a soft guidewire followed the

blood flow in the heart from the left ventricle into the aorta. After seeing these

videos, the Examiners noted that the claims of the ‘530 patent would be patentable

over the prior art if limitations were added concerning “the wire follows the blood

flow.” Ex. 1002 at 33. The Examiners’ proposed language was added to Claim 1

and to Claim 6 (id. at 36-37), and those claim were allowed. Id. at 14.

The dictionary definition of “configured” confirms that Patent Owner’s

construction is correct: “To design or adapt to form a specific configuration or for

some specific purpose” (Ex. 2010; emphasis supplied). Here, the wire becomes

shaped by the blood flow to achieve the anatomical curvature (a specific

configuration) necessary to accomplish the goal of entering the aorta (a specific

purpose). That goal requires a material shaping of the wire by the blood flow.

Other Claim Terms In The Petition Are Not Material At This Time

Because Petitioner’s proposed grounds of rejection fail even under Petitioner’s

proposed constructions set forth in the Petition, Patent Owner does not find it

necessary at this time to comment on Petitioner's proposed constructions and

reserves the right to do so if necessitated at a later date.

16

V. THE PETITION SHOULD BE DENIED UNDER § 325(D)

The Examiner Considered Both Bergheim and Lattouf In The Same Office Action

During prosecution of the application that issued as the ’530 patent, the

Examiner cited both Bergheim and Lattouf in the same Office action rejecting all

pending claims. Ex. 1002 at 206-207. The Examiner cited Bergheim as an

anticipatory reference under 35 U.S.C. § 102(e), (id. at 206), and cited Lattouf as

“disclosing related limitations of the applicant’s claimed and disclosed invention.”

Id. at 207. In response to that rejection, applicant filed the Huber Declaration

under Rule 1.131 establishing a prior conception date and diligence. Id. at 198-

199. Applicant also amended independent claim 1. Id. at 184. Thereafter, the

Office never again raised Bergheim in a rejection.

Regarding the Examiner’s removal of Bergheim as a reference, the Petition

states: “This is a puzzling result considering that the declaration did not include

any corroborating or supporting evidence.” Pet. 28. However, Office policy

governing Rule 1.131 declarations states that “averments made in a 37 CFR

1.131(a) affidavit or declaration do not require corroboration; an applicant may

stand on his or her own affidavit or declaration if he or she so elects.” MPEP

§ 715.07 (citing Ex parte Hook, 102 USPQ 130 (Bd. App. 1953)) (emphasis

added). Accordingly, Patent Owner’s traversal of the Bergheim rejection, in which

Lattouf was also cited, fit entirely within Office policy, without presenting

17

evidence to contradict the declaration that was submitted during prosecution.

Bergheim And Lattouf Are Factually Redundant As They Have Already Been Considered By The Office

Petitioner relies on the “same prior art” as the Examiner affirmatively relied

upon in a non-final rejection, and offers no new evidence or binding legal authority

that contradicts the Huber Declaration or Office policy that Rule 1.131 declarations

submitted during prosecution do not require corroboration. Therefore, the Board

should deny the petition under 35 U.S.C. § 325(d). Otherwise, the Board would

encourage a flood of IPR petitions by anyone who simply wishes to disagree with

an Examiner’s reliance on that Office policy.

VI. BERGHEIM IS NOT PRIOR ART BECAUSE IT DESCRIBES HUBER’S OWN WORK

Petitioner asserts Bergheim as prior art only under pre-AIA § 102(e). See Pet.

24. Pre-AIA § 102(e) “explicitly states that the reference at issue must be ‘by

another.’” Riverwood Int’l Corp. v. R. A. Jones & Co., 324 F.3d 1346, 1355 (Fed.

Cir. 2003) (quoting 35 U.S.C. § 102(e)). “The fact that an application has named a

different inventive entity than a patent does not necessarily make that patent prior

art.” Applied Materials, Inc. v. Gemini Res. Corp., 835 F.2d 279, 281 (Fed. Cir.

1987).) “An applicant may … overcome a reference by showing that the relevant

disclosure is a description of the applicant’s own work.” In re Costello, 717 F.2d

1346, 1349 (Fed. Cir. 1983) (emphasis added). For example, “[w]hen the 102(e)

18

reference patentee got knowledge of the applicant’s invention from him, as by

being associated with him, . . . and thereafter describes it, he necessarily files the

application after the applicant’s invention date and the patent as a ‘reference’ does

not evidence that the invention, when made, was already known to others.” In re

Land, 368 F.2d 866, 879 (CCPA 1966)) (emphases added).1

First, evidence submitted with this Preliminary Response demonstrates that the

named inventor of the Bergheim application, Mr. Bjarne Bergheim, learned of Dr.

Huber’s invention from Dr. Huber and thereafter filed the Bergheim application.

This evidence includes information related to a company called 3F Therapeutics,

Inc, (hereinafter, “3F”) the first assignee of the Bergheim Patent Application. Ex.

1004. Bergheim, who was the son of 3F Chairman of the Board Olav Bergheim,

assigned the Bergheim Patent Application to 3F on November 1, 20042 (Ex. 2008).

Specifically, the evidence includes a series of e-mails authored by Dr. Rodolfo C.

Quijano. Dr. Quijano was the founder of 3F and was also the Chief Technical

1 While these cases refer to an “applicant” before the PTO, “the same principle

applies to the use of a reference in a post-issuance validity challenge.” Riverwood,

324 F.3d at 1356.

2 On March 26, 2012 3F Therapeutics Inc. further assigned the Bergheim

Patent Application to Medtronic 3F Therapeutics Inc. (Ex. 2009)

19

Officer (“CTO”) of 3F during the relevant time period – i.e., from 1998-2005. Ex.

2017 at 5 (stating, in 2005, that “Dr. Quijano . . . has been Chief Technical Officer

of 3F Therapeutics, Inc. since 1998”). Quijano remained a consultant to 3F

thereafter until 2010. See Quijano letter to William O’Hare, Ex. 2012 at 1.

In October 2006, when Quijano was still working as a consultant for 3F,

Quijano wrote the following to Dr. Huber regarding Bergheim and the Bergheim

patent:

I think slowly (ti be desired (sic)) they will figure out that your

ideas and Ludwigs were stolen by Bjarne [Bergheim]. I did tell them

that when Bjarne asked me how to do a percutaneous/transluminal

valve with system <80 cm as we were granted by PVT /Anderson

patent, I told him, three routes: subclavian like you guys had done

before, infrarenal aorta as is possible surgicallym (sic) and lastly I said,

do it like Huber has been doing since 2002 with valves we donated,

but the idea was yours. Then two months later in Jan 2004 he declared

he had an idea for patent trans-apical trans-ventricular to Walter, Olav

his father and chairman of board of 3F. A lot of engineers left after

that because they knew they had made the valves for your use for over

2 years, and this guy claimed he invented it. Please keep this

confidential to protect me. Until they realize that he has really

nothing.

Ex. 2013 at 1 (emphasis added).

20

Prior to the above-quoted e-mail, Quijano had already indicated his interest in

Huber’s invention as early as April 2006, stating, in another e-mail to Huber, “I

really wanted to talk to you about what I consider your technology and wondered

if you had tried to patent it.” Ex. 2014 at 1 (emphasis added).

Quijano was in the best position, as CTO of 3F in 2004, to know whether

Bergheim invented anything or had merely taken the ideas in his patent application

from Huber’s research. The above-quoted passages, from two different Quijano-

to-Huber e-mails in 2006, illuminate the fact that Quijano believed that the ideas

included in Bergheim’s patent were derived from Huber’s ideas. In addition, the

fact that Quijano’s 2006 e-mails were against the interest of his then-current

employer, 3F, heightens the probative value of these e-mails.

In addition, Petitioner’s recent actions have shown that Petitioner values

Quijano’s testimony regarding the Huber Patent. Specifically, Petitioner recently

subpoenaed Quijano’s documents regarding the 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 and, also, subpoenaed Quijano to testify

in a deposition on January 12, 2016 regarding this matter. Ex. 2011.

Quijano rebuffed Petitioner, stating, “[d]uring the last 2 years, every few

months, the internal counsel at Edwards has asked me to help in the invalidation of

the patent issued to Dr. Huber, thinking that I have in my possession materials that

21

would cause that to happen” See, e.g., Ex. 2012 at 1. Quijano enclosed two

documents in his letter, one the Huber “New Tools for New Goals” presentation,

Ex. 2015, and the other a presentation from two years after the filing of the Huber

patent, Ex. 2027, both of which, on their face could not invalidate the patent, and

stated, “[s]hould I have on hand materials to invalidate the Huber patent, I would

produce immediately . . .”. (Emphasis added) Id. Regarding the deposition for

which Quijano was subpoenaed, Quijano likewise stated “This is also what will

result from the deposition for which I have been summoned.” Id. at 2.

In a futile effort to discredit Quijano’s testimony, Petitioner’s counsel even

insinuated that Quijano had sold his testimony to Huber, but Quijano denied this

allegation, stating, “I was not trying to sell testimony as [Petitioner’s] counsel

suggested.” Id. Following Quijano’s letter to William O’Hare, Petitioner did not,

to Patent Owner’s knowledge, go forward with the Quijano deposition on

January 12, 2016, nor, has Petitioner, to Patent Owner’s knowledge, rescheduled

Quijano’s deposition.

Second, as shown in the chart below, Dr. Huber, at the time of his presentation

in Scottsdale, Arizona in February 2004, Ex. 2015, possessed as much of the claimed

invention as Petitioner asserts is disclosed in the Bergheim application (filed April

2004). Cf. In re Spiller, 500 F.2d 1170, 1179 (CCPA 1974) (reversing obviousness

rejection over “Lichtenberger in combination with other references” based on

22

possession of elements disclosed in Lichtenberger alone); In re Mathews, 408 F.2d

1393 (CCPA 1969) (reversing § 102(e) rejection after applicant successfully

demonstrated prior invention of Dewey’s “gating means 19”, rather than everything

in Dewey).)

Bergheim disclosures cited in Petitioner’s

Claim Chart that relate to the ‘530 Patent

Evidence of Earlier Possession by Dr. Huber

‘530 Patent Claim Element 1.a -------------- Bergheim discloses a method for implanting a prosthetic heart valve. Ex. 1004, Abstract. Pet. 49.

Ex. 2015. New Tools for New Goals”, February 2004, at 17, reproduced, in part, below.

‘530 Patent Claim Element 1.b --------------Bergheim discloses a “valve replacement system compris[ing] a trocar or other suitable device to penetrate the heart at or near the apex of the heart . . .” (Ex. 1004, Abstract) Bergheim’s trocar “typically comprise[s] a hollow lumen and a first and second ends. The first end comprises a means for penetrating the heart tissue . . .” (Ex. 1004, ¶ [0040]) Figure 2 of Bergheim

“Off-pump Aortic Valved Stent Implantation – delivery device insertion, Through the LV (left ventricle) apex”, (Ex. 2015, “New Tools for New Goals” at 19);

Id. at 14 stating (“[a]ccess through a left sided

23

Bergheim disclosures cited in Petitioner’s

Claim Chart that relate to the ‘530 Patent

Evidence of Earlier Possession by Dr. Huber

illustrates that the myocardium of the apex 18 of the heart is penetrated by the tip of the trocar 31 having a sharp end. Pet. 49.

thoracotomy for exposure of the left ventricular apex.”) See also, id. at 4, showing delivery device loaded :

‘530 Patent Claim Element 1.c -------------- Bergheim teaches “[a]n inner element (59) [of the delivery member] . . . may be used for inserting a guidewire for controlling tip deflection or a fluid infusion conduit for balloon inflation.” (Ex. 1004, ¶ [0046]) The “balloon (41) [is] positioned in the aorta (22) and within the aortic valve (23) and aortic valve annulus (25).” (Id.)

“Off-pump Aortic Valved Stent Implantation – delivery device insertion.” (Ex. 2015, “New tools for New Goals” at 19 above); Neither claim 1 nor claim 6 recite “inserting a guidewire for controlling tip deflection or a fluid infusion conduit for balloon inflation.” This is discussed in more detail in § VIII.A.2. See also, (Ex. 2015, “New tools for New Goals” at 17).

24

Bergheim disclosures cited in Petitioner’s

Claim Chart that relate to the ‘530 Patent

Evidence of Earlier Possession by Dr. Huber

Bergheim further teaches “insertion of the delivery member (40) having a balloon expansion member (41) . . . [and] [a] collapsed replacement prosthetic valve (51) . . . into the port (32) of the trocar (31).” (Ex. 1004, ¶ [0047]) Pet. 49-50.

And see, Huber’s sworn Deposition Transcript: Q.· But the concept of following the blood flow or using the blood flow or having something directed by the blood flow was not disclosed in Scottsdale; correct? A.· I don't think the presentation was videotaped.· If it was, we could try to get access to that one.· But so, in order to be sure about the nature of the words I used of being excited in giving one of my first · international talks, it would be difficult to exactly tell you what I used as words. But I know that I certainly used the· word, a floppy guide wire.· I certainly used the word, antegrade.· I certainly used the word that we go with the blood flow, and that makes, that facilitates the procedure. (Ex. 2005, 1/27/16 Huber Dep. Tr., 75:5-20) (emphasis added).

‘530 Patent Claim Element 1.d --------------Figure 2 of Bergheim illustrates a trocar 31, which is a type of access device, installed in the wall of the left ventricle of the heart. (Ex. 1004, FIG. 2; Ex. 1026, ¶¶ 64-65)

“Off-pump Aortic Valved Stent Implantation – delivery device insertion, Through the LV (left ventricle) apex” (Ex. 2015, “New Tools for New Goals” at 19) (above) See also, id. at 4, with reference to 1.b.

25

Bergheim disclosures cited in Petitioner’s

Claim Chart that relate to the ‘530 Patent

Evidence of Earlier Possession by Dr. Huber

Pet. 50. ‘530 Patent Claim Element 1.e -------------- Bergheim discloses the trocar includes “a valve disposed within the lumen. The valve is designed to reduce significant backflow of blood out of the heart after the trocar is inserted into the beating heart . . .” (Ex. 1004, ¶ [0041]) Similarly, Lattouf discloses “[t]he valve component 35 . . . is a duck billed valve component formed of polymeric material which allow the passage of instruments for deployment or treatment but prevent or at least minimize loss of blood through the heart wall.” (Ex. 1005, ¶ [0055]) Pet. 51-52.

“Off-pump Aortic Valved Stent Implantation – delivery device insertion” (Ex. 2015, “New Tools for new Goals” at 19)(above); See, also, id. at 4, with reference to 1.b. Neither claim 1 nor claim 6 requires a valve that is designed to reduce significant backflow of blood out of the heart after the trocar is inserted into the beating heart. Nevertheless, Dr. Huber testified in his deposition as follows:

Q. Now, is that what's described there, the iris diaphragm, was that something that you used in the pig studies at CHUV? . . . A. I don't know what the mechanism was in the pig study used device.· It had a hemostatic, as we call, it valve. (Ex. 2016 1/29/16 Huber Dep. Tr., 245:8-246:6.)

‘530 Patent Claim Element 1.f -------------- Bergheim discloses “[t]he delivery member of the valve replacement system is adapted to deliver the prosthetic valve to the site of implantation, through

“Off-pump Aortic Valved Stent Implantation – delivery device insertion”) (Ex. 2015, “New Tools for New Goals” at 19 above). See also, id. at 4, with reference to Element 1.b. Neither claim 1 nor claim 6 recite “a balloon expansion member.”

26

Bergheim disclosures cited in Petitioner’s

Claim Chart that relate to the ‘530 Patent

Evidence of Earlier Possession by Dr. Huber

the apical area of the heart.” (Ex. 1004, ¶ [0042]) FIG. 7 of Bergheim depicts “insertion of the delivery member (40) having a balloon expansion member (41) . . . [and] [a] collapsed replacement prosthetic valve (51) . . . into the port (32) of the trocar (31).” (Id., ¶ [0047]) Pet. 52. ‘530 Patent Claim Element 1.g -------------- FIGs. 8 and 9 of Bergheim illustrate that “[t]he replacement valve (51) . . . as being positioned within the aortic valve (23). In particular, “FIG. 9 depicts the radial expansion (52) of the balloon (41) causing the replacement valve (51) to press against the aortic valve leaflets (24) of the aortic valve (23) against the annulus (25).” (Ex. 1004, ¶ [0048]) Bergheim discloses the installation of a heart valve via a same transapical approach as Lattouf. (Ex. 1004, Abstract, ¶¶ [0045] –

“Off-pump Aortic Valved Stent Implantation – delivery device insertion” (Ex. 2015, “New Tools for New Goals” at 19 above). See, also, id. at 4; id. at 14 (stating “[a]ccess through a left sided thoracotomy for exposure of the left ventricular apex”); and id. at 17 (stating, “Off-pump implantation of a self-expanding Valved Stent in the Orthotopic aorta over the native leaflets.”). Bergheim does not discuss the installation of a heart valve via a same transapical approach as Lattouf.

27

Bergheim disclosures cited in Petitioner’s

Claim Chart that relate to the ‘530 Patent

Evidence of Earlier Possession by Dr. Huber

[0048]) Pet. 52-53.

All the portions of Bergheim cited in Petitioner’s claim chart with respect to

claim 6 were included in Petitioner’s claim chart with respect to claim 1. Pet. 53-

56. Therefore, the same citations to Dr. Huber’s work above are equally applicable

with respect to claim 6.

Third, because the evidence discussed above demonstrates that all the cited

portions of Bergheim describe Dr. Huber’s own work, Bergheim is removed as a

§ 102(e) reference, even in the absence of a showing of “diligence and/or reduction

to practice.” In re DeBaun, 687 F.2d 459, 463 (CCPA 1982) (reversing obviousness

rejection where reference described “appellant’s own invention,” despite applicant’s

“fail[ure] to allege facts showing the necessary diligence and/or reduction to practice

of the invention”). Therefore, Bergheim is not prior art under § 102(e), even

ignoring the Huber Declaration and evidence of diligence and reduction to practice,

discussed below.

VII. BERGHEIM IS NOT PRIOR ART BECAUSE IT IS ANTEDATED

Separately, Bergheim is not prior art under § 102(e) because Dr. Huber

conceived of the invention before Bergheim’s filing date and was diligent in

28

reducing the invention to practice. For two independent reasons discussed below,

Bergheim is antedated.

Petitioner’s Arguments Against The Huber Declaration Lack Merit

During prosecution, the Examiner agreed that the Huber Declaration was

sufficient to antedate Bergheim. Petitioner’s three attorney arguments against the

Huber Declaration lack merit. And, having failed to submit any new evidence on

this antedating issue whatsoever in its petition, Petitioner has not met its burden for

instituting inter partes review.

Petitioner’s first attorney argument is that “the Huber Declaration … provides

no corroborating evidence to show conception of the invention or diligence in

reducing the invention to practice.” Pet. 42 (emphasis added). But, unlike in

interferences or litigation, “averments made in a 37 CFR 1.131(a) affidavit or

declaration do not require corroboration; an applicant may stand on his or her

own affidavit or declaration if he or she so elects.” MPEP § 715.07 (citing Ex

parte Hook, 102 USPQ 130 (Bd. App. 1953)) (emphasis added). Countless

applicants have relied on this MPEP statement over the years when filing Rule

1.131 declarations. See Hyatt v. Dudas, 492 F.3d 1365, 1369 (Fed. Cir. 2007)

(“Although the MPEP does not have the force of law, the MPEP is made available

to the public and describes procedures on which the public can rely.”) (citations

and alterations omitted). Petitioner cites no binding authority for a requirement

29

that “corroborating evidence” is needed as part of a Rule 1.131 declaration

submitted during original prosecution (unlike antedating attempts made in

litigation or interference).

Petitioner’s second argument, which differs little from its first argument, is that

“no evidence of conception has been provided” as to each of the challenged

claims. Pet. 42. But again, the Huber Declaration is itself “evidence,” and in it Dr.

Huber specifically avers, “I conceived the present invention prior to April 23,

2004.” Ex. 1002 at 198, ¶ 5. To require more “evidence” beyond the affidavit or

declaration itself, such as lab notebooks or eye witnesses, would contradict the

MPEP’s instruction that “averments made in a 37 CFR 1.131(a) affidavit or

declaration do not require corroboration.” MPEP § 715.07 (emphasis added).

Petitioner’s third argument is that the provisional application is not a

“constructive reduction to practice” because it “does not meet the written

description requirement.” Pet. at 42-43. But even assuming this were true,

Petitioner’s focus on the provisional application ignores the fact that the regular

application was filed shortly thereafter—indeed, less than 3 months after the

provisional. Moreover, the Huber Declaration’s averments regarding diligence do

not stop at the filing of the provisional application; Dr. Huber states, “I diligently

pursued the constructive reduction to practice of this invention by filing the

Provisional Application and later on by contacting a US representative who

30

prepared and filed the present application.” Ex. 1002 at 198 (emphasis added).

Dr. Huber’s averments encompass the entire 3-month gap. Petitioner does not

argue that a 3-month gap between a provisional and regular application filed by an

inventor’s attorney constitutes insufficient diligence on the part of an inventor

(particularly in light of the 12-month statutory period to file a non-provisional

application after a provisional application filing). What is more, Petitioner has

made no argument whatsoever that any period of diligence in the Huber

Declaration contains any unexplained gaps or is otherwise inadequate. Having

failed to make any argument against the Huber Declaration’s diligence showing,

Petitioner has waived that argument.

In sum, Petitioner has made no meritorious argument, and has presented no

evidence whatsoever, to show that the Examiner was wrong to accept the Huber

Declaration during original prosecution as Office policy permits. The petition

should be denied for this reason alone.

Additional Evidence Confirms That Bergheim Was Properly Antedated

Even if the Board were to set aside the Office’s longstanding policy in the

MPEP that “averments made in a 37 CFR 1.131(a) affidavit or declaration do not

require corroboration” as set forth in MPEP § 715.07; nevertheless, the Huber

Declaration is corroborated by additional evidence submitted with this Preliminary

Response. The Board must consider this evidence at institution. See 35 U.SC.

31

§ 314(a) (requiring institution to be based on “information presented in the petition

… and any response filed under section 313”). The following evidence comes

from the co-pending litigation in the United States District Court for the District of

Delaware Case No. 1:14-cv-01473, and thus does not constitute impermissible

“new testimonial evidence” under 37 C.F.R. § 42.107(c).

1. Prior conception

The following evidence corroborates that Dr. Huber conceived of the

inventions described in claims 1 and 6 of the ’530 patent, prior to Bergheim’s

filing date of April 23, 2004. In a sworn deposition dated January 27, 2016, Dr.

Huber testified to the following:

Q.So, turning to the second point you had about size of the opening

in the pig versus the human, can you explain to me how your invention

solves that problem that you've identified?

A. So, as I mentioned with pigs, there is no heart, no animal model

that allows you to accurately simulate aortic valve stenosis, for

example, pigs.· So, I was left with one issue.· The pig animals were

presented and seemed to work very fine, but I didn't know what

happened if you had aortic valve stenosis to cope with.

And this was one of my reflections and issues I had to solve to

get that procedure successful; because, ultimately, it was supposed to

save the patients' lives, and that's what I wanted, that's what I was

trained for, that's what my aim is and profession is, to help patients and

save patients lives.

32

While I didn't have the solution while doing those animal

experiments, and while I was on my way from Switzerland from

Lausanne with my wife, pregnant with twins, on my way from Geneva

to Boston, I stood at Geneva airport, and while I was quite stressed we

might miss the plane, even though we got there in time, and we couldn't

move as fast as we wanted to, but we were standing there watching

people trying to push through the gates.· And there was quite a large

crowd outside the gates, and obviously there was very little, only one

by one, like a drop by drop going through the gate.

And this interesting concept suddenly made me aware that the

solution was right in front of my eyes; that the gate was the stenosis,

and all the people trying to get through the gate were, was the blood in

the left ventricle.· And they tried to push through, and people in the

middle were principally dragged nearly through that gate.

And that's where I said, well, yes, that's the trick, that's the

invention; that if we can, if this works, then that's the solution to the

problem.

Q.And did you -- so, okay.

You saw the people going through the gate, and you thought

about this drag.· How did that then translate into the next thought, how

did that lead to, oh, it's a soft guide wire, or whatever your next

realization was?

A. Well, it was pure deduction, I said, if people, this is a flexible

mass of people, if I put anything into that stream that is soft enough to

help by the stream to go to the gate, go through the aortic valve, that

will be most likely the solution.·

33

I didn't have proof of concept, but for me that was the key

element to my· · invention that bonded and joined all different steps

that are found in claim 1 to make the whole claim 1 work; that was

to take a wire that was configure, or configured, you call it soft, to

allow it to go through the narrow passageway, the gate or the aortic

valve, and aided or helped by the blood flow to do so.

Ex. 2005, 1/27/16 Huber Dep. Tr., 17:18-20:13. See also, id. at 51:16-52:7; 80:2-

5.

Dr. Huber further testified that the facts set forth above occurred on

December 28, 2003:

Q.Going back to, you said you were at the airport, and you saw the

people, and that's what led to this idea that you had. When was that?

A. That was the day I left Lausanne to go to Boston; that's

December 28, 2003.

Id., 48:4-9.

Moreover, the claim chart in section VI, above, shows that Dr. Huber

conceived as much of the claimed invention as Bergheim is alleged to disclose.

See In re Spiller, 500 F.2d at 1170, 1179.

2. Diligence

The following evidence corroborates that Dr. Huber (a busy individual inventor

working alone) was diligent in constructively reducing his invention to practice,

from just before Bergheim’s filing date of April 23, 2004, through the filing of Dr.

Huber’s own patent applications on October 2, 2004 and December 28, 2004.

34

Regarding Dr. Huber’s diligence from December 28, 2003 through the filing of

Dr. Huber’s own patent applications on October 2, 2004 and December 28, 2004,

Dr. Huber testified:

Q. So, you get to the U.S.·You settle down; right?· The stress

of the travel is over. What is the next thing you did, if anything, relating

to this invention, did you,·again, I'm looking for, did you write stuff

down, did you talk to people, did you do more experiments, you know,

what if anything happened next and when?

A. So, first of all, you asked, you said, travel is over, you

settled down.· The settling down is not as fast and easy as one can

imagine, you certainly know how difficult it is to settle in a country, so.

But, no, during that period, I was fully focused to get my future

family safely in the harbor there in Boston.· And we had to move

around.· We came to the Lennox Hotel first and stayed there until

somehow after new year.· And I remember having seen the new year

fireworks.·

And then we went to a colleague and stayed at their house. And

then we had to leave that house very, very unexpectedly, let's say, and

we had to find a place to live and find furniture.

·· · I went to IKEA in New York on the day of, what was it, it

was any kind of, not Superbowl but the match before the Superbowl

with the Boston, what's the name of the Boston, Patriots?

Q.· Patriots, yep.

A.· Patriots.· And I remember that day we had to leave that

gentleman, he was chief of cardiology at Mass Gen Hospital, and we

35

had to leave because he didn't want to have us there anymore, because

we asked what I thought was an appropriate, but an inappropriate

political question.

Anyway, the morning he opened up and said, Christoph, I would

like you to leave today.· And, well, I didn't have any furniture, nothing,

my wife was pregnant. I rushed down, bought a U-Haul, went to IKEA,

the IKEA store was closed in New York.

This was kind of a nightmare. I bumped a lawyer's car, a very

nice black lady, she had a child in the back seat, everybody was in a

rush to get and see that game.· I had my huge U-Haul, and I just dented

that car very slightly, it was no big deal.· But I said, oh, my God, now

I'm screwed, I will never get out of the U.K.

I was really, I'm laughing now, but it really were.· Just to

illustrate that landing there was not like (indicating), okay, it's all done,

but probably you would know, as well.

And afterwards, well, the next step was starting to work at

Brigham and Women's Hospital, and that was the next cold shower,

really because, first of all, the new language, I was able to speak English

but not at that extent.· But then I had to start doing surgery at a higher

level than I had expected, really, even though I joined as a junior

Fellow for three months.· But there were 120 hours, there was no 80-

hour work relations at that time.

So, I started from, let's say, a controlled work environment in a

so abrupt, this was like a trauma, 120 hours workweek environment in

ICU, I didn't work in ICU before, and had to get used to all that.

36

So, all this really has a dynamic ·that did, really, didn't put in the

my priority list to get the idea yet tackled, the invention from 28

December 2003 tackled.

This was always in the back of my head.· And I, also, while I

started having my twins, having relocated, etcetera, I already had some

talks that were organized from before, for example, the ISCS talk in

Scottsdale, Arizona in February 2004.

So, all that was in parallel. I had to prepare my presentation.·

There were really, really many things.· And I hope this gives you kind

of an impression how, how the workload was, and how diversified, how

versatile the workload was, diverse the workload was.

And, yes, this gives you a glimpse on how the start was. We were

very nicely ·welcomed in the U.S., and it was a great time we spent in

the U.S., but the start was difficult.

Q.So, back to the question of what did·you do next, and when

with respect to the idea ·you had that you said on December 28th,

2003?

A. So, what happened next, really, was a discussion with an

employee of St. Jude Medical, and he happened to be a long-standing

person I trusted.· He also happened to be the CEO of St. Jude Medical

USA.· And we had, I don't know if you can call this regularly, but we

had several contacts by phone for a lot of topics, and we had been --

and I called him to ask what, what I should do.

I invented this procedure, I invented this step that we discussed

extensively now, that is, to use a wire that is configured to conform to

a direction of blood flow, and what should I do with that?

37

To be honest, I didn't really have an understanding about IP.· I

was just starting to be trained to be a doctor, and doctors don't get taught

on business, on IP, or nothing like that.· There's enough to learn already

as a doctor, and even more so to become a cardiac surgeon.

And he said, well, yeah, that's interesting. You have to set up,

first you have to have a patent, and you have to set up a company. And

after you have set up those ·two entities, you get back to me and we

discuss it.

· I said, George, but the cost, etcetera, I don't have the money, and

can you help, is that something you're interested in? And he said, yes,

we can help you.

So that's how things started. And now I am initiation process to

the patent.

Maybe I'll get you back to asking me questions.

Q.You mentioned his name was George. What's his last name?

A. Fazio.· Still is.

Q.When did you first contact Mr. Fazio?

A. Well, the very first contact we ever had or...

Q.About your invention.

A. This was, oh, somewhat, somewhere the first half of 2004.

Q.Can you be any more specific on the date or you just don't

know, it was some time ·during the first half?

A. No.· Because we also had, I think, a conversation with him about

finding a flat. I mean, there were other things. I don't know when

exactly I spoke with him to discuss the patent or the invention issue,

but I would ·really restrict it to the first half of 2004.

38

Q.When did you first start drafting the provisional patent

application?

A. That was after he discussed and recommended that I have to

make a patent.· And I said, well, how do you make a patent?· He said,

it's very easy, just have to send a provisional patent to the U.S. Patent

& Trademark Office.· You pay, I think it was, a hundred twenty bucks

at the time, and that's it, and that's what I did here.· I think that's the

product of that.

Q.So, you think it was sometime in the first half of 2004, do you

think it was the second half of 2004 that you sent a draft? I mean, it was

filed in October, if that's helpful.

A. I know.

Q.I'm trying to figure out when you ·started working on it?

A. Well, I started to work three months as a junior fellow, I was

really, really busy.· Then I was moved a little early actually to become

a senior fellow, and became really busy again with new functions and

responsibilities.

And it must have only happened at a time I started to feel more

comfortable with the process at the hospital. And then the twins also

were born in May, 4th of May 2004.

I think this drafting of the patent was rather, I can't be really

accurate, but summer, maybe that I start thinking of how to do it, or

maybe later.

(Ex. 2005, 1/27/16 Huber Dep. Tr., 58:2-65:16).

Thus, Dr. Huber was “reasonably diligent” throughout this period, taking into

account “the reasonable everyday problems and limitations encountered by an

39

inventor.” Griffith v. Kanamaru, 816 F.2d 624, 626 (Fed. Cir. 1987) (citing Reed

v. Tornqvist, 436 F.2d 501 (CCPA 1971) (concluding it is not unreasonable for

inventor to delay completing a patent application until after returning from a three

week vacation in Sweden, extended by illness of inventor’s father); Keizer v.

Bradley, 270 F.2d 396 (CCPA 1959) (delay excused where inventor, after

producing a component for a color television, delayed filing to produce an

appropriate receiver for testing the component); Courson v. O'Connor, 227 F. 890,

894 (7th Cir. 1915) (“exercise of reasonable diligence … does not require an

inventor to devote his entire time thereto, or to abandon his ordinary means of

livelihood”)).

VIII. GROUND 1 FAILS TO DEMONSTRATE A REASONABLE LIKELIHOOD OF UNPATENTABILITY

Petitioner Has Not Addressed How The Prior Art Meets Elements 1c And 6c Beyond Merely Disclosing An Antegrade Approach

Petitioner has failed to articulate how the limitation “configured to conform to

a direction of blood flow” in Elements 1c and 6c, properly construed, is present in

the prior art, beyond merely disclosing an antegrade approach. As explained above

regarding the construction of this term, Petitioner incorrectly equates this term with

“antegrade.” Instead, the correct construction requires the wire to possess a

40

property or structure for adapting to the direction of blood flow, which neither

Bergheim nor Lattouf disclose, either expressly or inherently3.

3 Petitioner cites, repeatedly, to Patent Owner’s Markman brief for a purported

admission regarding what the prior art discloses. Those statements are confusingly

taken out of context. The issue of what the prior art discloses, including Lattouf,

goes to the second step of an anticipation or obviousness analysis—after the

claims are first properly construed. The second step was not at issue in the

Markman briefing, and Patent Owner made clear that "nothing was said [during

prosecution] about the structure of the [Lattouf] guidewire itself.” Ex. 1027 at

6. In any event, Patent Owner’s proposed claim construction of “configured to

conform” in the Markman briefing is the same as in this IPR proceeding.

41

Bergheim and Lattouf (Petitioner's interpretation) are rendered by Patent

Owner schematically, in Schematics D and E, below.

Neither Bergheim nor Lattouf, alone or in combination, teach or suggest “a

wire configured to conform to a direction of blood flow,” as recited in elements 1c

and 6c of claims 1 and 6, respectively. Pet. 49-50. Neither Bergheim nor Lattouf

contribute to the Petitioner's combination a wire that is configured to conform the

blood flow. Absent this element, Petitioner cannot demonstrate a reasonable

likelihood that claims 1 and 6 would have been obvious.

1. Lattouf does not expressly disclose elements 1c and 6c

Petitioner’s claim chart alleges that “Lattouf discloses piercing the heart wall at

or near the apex and advancing a guidewire 'through the inner lumen of the needle

42

into the heart chamber and further advanced through the valve to be treated.'" Pet

at 50 (citing Ex. 1005, ¶ 10).

The relevant portion of Lattouf, FIG. 10 (Ex. 1005 at 5)

is shown at left. Guidewire 53 extends from the apex into

left ventricle 12 and passes mitral valve leaflets 14 and 15

into left atrium 11. Grasping device 40, which includes

elongated shaft 41 and jaws 42, is slidably advanced over

the guide wire through the valve 30 and into the left atrium

through mitral valve 13. (Ex. 1005, ¶ 57.)

Petitioner argues that Lattouf "explicitly discloses that

one of the areas of the heart that can be treated with this procedure is the aorta,

including 'aortic stenting for aortic dissections and aneurysm therapy.'". Pet. 50

(citing Ex. 1005, ¶ 8). This mention of the aorta is the only mention of aorta in the

entire Lattouf document.

Petitioner alleged merely that Lattouf discloses piercing the heart wall at or

near the apex and advancing a guidewire 'through the inner lumen of the needle

into the heart chamber and further advanced through the valve to be treated.'". Pet.

49 (citing Ex. 1005, ¶ 10).

43

As set forth above, Lattouf teaches a guidewire that can lead from the apex to

the mitral valve opposite the direction of blood flow. Lattouf does not teach a

separate and different guidewire in connection with the single sentence in Lattouf

that touches on aortic procedures. Ex. 1005, ¶ 8 ("Other procedures which may be

performed include…aortic stenting

for aortic dissections and

aneurysm therapy…".) Schematic

F is a rendering by Patent Owner

showing the Petitioner's proposed

application of Lattouf to the

claims. "Lattouf (Following

Lattouf figs)", which describes

retrograde, shows a guidewire

leading from the apex to the mitral valve. The guidewire must be able to overcome

the oncoming blood flow from the mitral valve. "Lattouf (Following Petitioner’s

Position)", which describes antegrade, shows the guidewire disposed in the aortic

valve. Nothing about "Lattouf (Following Petitioner’s Position)" speaks of a wire

that is "configured to conform to a direction of blood flow," even though the wire

is aligned with the blood flow. Petitioner also recognized this: "In summary,

Lattouf describes a method for treating the aorta with stent devices and repairing

44

heart valves via access from the apex of the heart, from both the antegrade and

retrograde directions." Pet. 53. That is, the procedure of Lattouf can be performed

in one direction or the other—using the same apparatus — which logically must be

a rigid guidewire if it is to be used retrograde. Thus, nothing in Lattouf expressly

discloses a loose or floppy guidewire used in aortic procedures in the antegrade

direction or that otherwise conforms to the direction of blood flow.

2. Bergheim does not expressly disclose elements 1c and 6c

Bergheim FIG. 3 (Ex. 1004 at 4) is

reproduced at right.

Delivery member 40, carrying balloon 41,

enters apex 18 and traverses left ventricle 21

toward native aortic valve 23 during a

valvuloplasty procedure. Id., ¶ 44.

FIG. 9 (Id. at 10), below, shows that balloon 41 may be used to expand

replacement valve 51 in aortic valve annulus 25.

Id., ¶ 48. Balloon 41 may include inner element 59,

as shown in FIG. 6 (Id.at 7), below. Id., ¶ 46.

45

Petitioner’s claim chart cites paragraph 46 of

Bergheim, which states: “An inner element (59) may

also be used for inserting a guidewire for controlling

tip deflection . . . .” Id., ¶ 46 (emphasis added); Pet.

49. That is the sole mention of “inner element (59)” in

the specification. Bergheim’s claims 24-26 add further

color to this “inner element,” explaining that “the inner element is used for

inserting a guide wire or a pulling wire for controlling the tip deflection,” and “the

inner element is a fluid infusion conduit for the expansion and contracting

member.” Ex. 1004, cl. 24-26. There is no other mention of a guidewire in

Bergheim.

Bergheim FIG. 4 (Id.at 5), at right, shows tip 42.

The guidewire of claim 25 for controlling tip

deflection would require sufficient stiffness to change

the deflection of tip 42, presumably relative to more

proximal portions of the Bergheim apparatus.

Overcoming the resistance of the apparatus would require stiffness far greater than

the resistance of blood. The claim 25 pulling wire for controlling tip deflection

would require maintaining the pulling wire in an eccentric lumen in opposition to

delivery member 40 so that tension in the pulling wire deflects tip 42 relative to

46

more proximal portions of the Bergheim apparatus. Stiffness of delivery member

40 would be used to counter-deflect tip 42 and would prevent the pulling wire from

conforming to blood flow.

Thus, Bergheim does not expressly disclose a guidewire that is configured to

conform to the direction of blood flow.

Elements 1c And 6c Are Not Necessarily Present In The Prior Art To Meet The High Standard For Inherency

Petitioner appears to rely on the doctrine of inherency to meet the limitation

“configured to conform to a direction of blood flow” in Elements 1c and 6c. See

Pet. 47-48 ("the guidewires disclosed by Bergheim and Lattouf would necessarily

have been designed to conform to a direction of blood flow); id. 50, 54 (asserting

for Elements 1c and 6c that the "techniques employed by Bergheim and Lattouf

were known to result in the guidewires conforming to a direction of blood flow")

(emphases added). However, Petitioner has not met the “high standard” that is

required “in order to rely on inherency to establish the existence of a claim

limitation in the prior art in an obviousness analysis.” Par Pharm., Inc. v. TWi

Pharms., Inc., 773 F.3d 1186, 1195-1196 (Fed. Cir. 2014). As the Federal Circuit

has explained, “the limitation at issue necessarily must be present, or the natural

result of the combination of elements explicitly disclosed by the prior art.” Id.

(emphases added). As explained below, Petitioner’s own cited references show

that the prior art guidewires on which Petitioner relies would not necessarily have

47

conformed to a direction of blood flow.

1. Semple and Seldinger contradict the principles that Dr. Garrett attempts to extract from them

In support of its assertion that the “Bergheim and Lattouf” techniques were

“known to result” in guidewires conforming to a direction of blood flow, Petitioner

cites to the 1968 article by Semple (Ex. 1024). Pet. 50. Notably, Petitioner does

not suggest modifying Bergheim and Lattouf’s techniques by substituting any one

of their guidewires for Semple’s guidewire. Rather, Petitioner cites Semple as

evidence to prove that the “techniques employed by Bergheim and Lattouf were

known to result” in the guidewires being controlled by the blood flow. Id.

However, this assertion is merely attorney argument because, as will be discussed

below, nowhere in Petitioner’s expert declaration is Semple even mentioned, much

less discussed with any specificity.

Semple performed pressure measurements based on modifications of the

teachings of Levy and Lillihei (1964) (Ex. 2003). Ex. 1024 at 402. Semple

replaced the Levy and Lillihei needle with a narrower needle, over which a soft

teflon catheter was snugly fit. Id. The catheter, with needle acting as trocar, was

inserted through the ventricular wall. Id. Upon detection of blood pressure

through the needle, the catheter was advanced beyond the needle and the needle

was withdrawn, leaving the teflon catheter alone in the left ventricle. Id. As the

Petitioner stated, quoting Semple, “In most cases, further gentle advancement of

48

the soft teflon catheter takes it into the aorta along with the blood flow.” Pet. 50,

54 (quoting Ex. 1024 at 402) 4. Semple stated that the catheter was a “completely

flexible teflon catheter.” Ex. 1024 at 405. The teflon catheter was so soft that it

was necessary to advance the Teflon catheter an inch or two into the ventricle

before withdrawing the needle to “prevent the soft catheter from entering the

pericardium and looping outside the heart as happened in two of our early

patients.” Id.

In some cases, as Semple implies, the completely flexible teflon catheter did

not go along with the blood. In those cases, as the Petitioner stated, further quoting

Semple, “a Seldinger guide wire is introduced and this usually passes easily into

the aorta, the teflon catheter following.” Pet. 50, 54 (quoting Ex. 1024 at 402)

(emphasis added). Thus, Lattouf’s stiff wire is used to rescue the stranded teflon

catheter by being inserted into the catheter. The wire itself is not configured to

conform to the direction of blood flow.

As set forth above, Seldinger taught primarily a retrograde procedure—one in

4 In its Claim Construction 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, Petitioner suggested that configured to conform

means “along with.” Ex. 2004 at 8.

49

which the wire is advanced against blood flow. This is consistent with Semple's

application of Seldinger, because Semple teaches that “left atrial catheterization

may be attempted through the mitral valve”—a retrograde approach using the soft

catheter and the “Seldinger guidewire,” which would have to have been stiff

enough for the retrograde procedure. Ex. 1024 at 402. Thus, although Petitioner

analogizes from Seldinger to Bergheim and Lattouf to show that both Bergheim

and Lattouf would have been known to conform to the blood flow, the opposite is

true of the Semple/Seldinger approach: the Semple/Seldinger wire was configured

to not conform to the blood flow.

2. Dr. Garrett improperly derived from Seldinger that Lattouf necessarily conforms to the direction of blood flow

Petitioner’s expert, Dr. Garrett, reasons that merely because Lattouf

implements the Seldinger technique, the Lattouf guidewire “must necessarily”

conform to the direction of blood flow. Ex. 1026, ¶ 77. Seldinger advanced a wire

against the blood flow. And Semple demonstrated that, like Lattouf, a stiff wire is

required to traverse the mitral valve in the retrograde direction. Dr. Garrett thus

fails to explain why implementing the Seldinger technique means that a guidewire

“must necessarily” conform to the blood flow.

Further compounding Dr. Garrett’s lack of explanatory rigor above, Dr. Garrett

does not even cite to an actual Seldinger reference to support the declaration’s

reliance on the “renowned Seldinger technique.” Ex. 1026, ¶ 79. Instead, Dr.

50

Garrett cites to a single slide in an undated slide presentation by an individual

named Sarbesh Tiwari, PGT. Ex. 1026, ¶ 72 n.66 (citing Tiwari, Ex. 1041).

Without a publication date, this presentation has not been shown to be prior art and

thus cannot be used as evidence in support of obviousness.

3. Petitioner’s reliance on Semple is mere attorney argument

Petitioner argues that “the guidewires disclosed by Bergheim and Lattouf

would necessarily have been designed to conform to a direction of blood flow."

Pet. 48 (emphasis added). Petitioner attempts to support this statement with

citations to Semple (Ex. 1024 at 402) and the declaration of its expert Dr. Garret

(Ex. 1026, ¶ 79). But nowhere in Dr. Garrett’s declaration is Semple even

mentioned, much less explained in any detail. Therefore, Petitioner's position that

Semple somehow confirms that the guidewires of Bergheim and Lattouf "would

necessarily have been designed to conform to a direction of blood flow” is merely

attorney argument. That argument is also conclusory, because it does not explain

how the Semple guidewire is in any way related to, or is the same as, the

guidewires of Bergheim and Lattouf (which, as Patent Owner has explained above,

were relatively stiff wires used in retrograde techniques). See In re Geisler, 116

F.3d 1465, 1470 (Fed. Cir. 1997) (attorney arguments and conclusory statements

that are unsupported by factual evidence are entitled to little probative value).

Therefore, Petitioner has not met and cannot meet the “high standard” required

51

“in order to rely on inherency to establish the existence of a claim limitation”

(here, a wire configured to conform to a direction of blood flow) “in the prior art in

an obviousness analysis.” Par, 773 F.3d at 1195-96.

IX. REAL PARTY-IN-INTEREST

In this preliminary response, Patent Owner identifies evidence to satisfy its

“burden of production” that Petitioner has “failed to identify all real parties-in-

interest in its petition.” Atlanta Gas Light Co. v. Bennett Regulator Guards, Inc.,

IPR2013-00453, Paper 91 at 6 (PTAB Feb. 23, 2015). Specifically, evidence

accompanying this response and described below is probative that a subsidiary of

Petitioner—Edwards Lifesciences PVT, Inc. (“Edwards PVT”)—is an unnamed

real party-in-interest, sufficient to question Petitioner’s burden of persuasion on the

issue. Id. (“[T]he burden of persuasion or proof that the petitioner has named all

real parties-in-interest remains with the petitioner.”). While Petitioner selectively

named another of its subsidiaries as a real party-in-interest— Edwards

Lifesciences LLC (“Edwards LLC”)—Petitioner did not name Edwards PVT.

First, each and every ground of unpatentability in Petitioner’s two petitions

relies on an alleged prior art patent application or related publication that is owned

by or licensed to Edwards PVT, viz., Bergheim (Ex. 1004); Cribier (Ex. 1009); and

Spenser (Ex. 1010). Bergheim was originally owned by 3F Therapeutics (now

Medtronic 3F Therapeutics) (Ex. 2008), which granted a “non-transferable” license

52

to Edwards PVT for the purpose of practicing Bergheim’s technology in 2005 (Ex.

2018). Cribier is a 2002 journal article whose first author is Alain Cribier and

which acknowledges “support in the research program and development of the

device” by a company called “Percutaneous Valve Technologies, Inc.” Ex. 1009 at

3006, 3008. Percutaneous Valve Technologies, Inc. was acquired by Petitioner in

2004. Ex. 2019. Upon acquisition in 2004, Percutaneous Valve Technologies

recorded assignments of U.S. patents and applications to Edwards PVT, rather than

to any other Edwards entity. Ex. 2020. Moreover, every single U.S. patent that

names Alain Cribier as an inventor or co-inventor and which issued on or after

2004 (U.S. Patent Nos. 6,908,481; 7,585,321; 7,846,203; 7,846,204; 8,002,825;

8,057,540; 8,591,575; 9,095,432) names Edwards PVT as the assignee. Ex. 2021.

Spenser is one of the patent applications that Percutaneous Valve Technologies

assigned to Edwards PVT in 2004. Ex. 2020 at 12.

Second, Edwards PVT appears to be a practicing entity rather than merely a

holding company within Petitioner’s family of companies. Ex.2022. Indeed,

unlike the U.S. patents and applications owned by Edwards PVT and asserted as

prior art in this proceeding, Edwards Corporation and Edwards LLC themselves

own other U.S. patents and applications that are not asserted here as prior art. Ex.

2023. Moreover, the fact that 3F Technologies licensed the Bergheim application

to Edwards PVT under a “non-transferrable” license except for “affiliates” that

53

Edwards PVT itself “controls” (Ex. 2018), suggests that Edwards PVT is the

entity that actually uses the technology and would stand to directly benefit from a

cancellation of Patent Owner’s patent in the instant proceeding, rather than

Edwards LLC, for example. The two named parties here, Edwards Corporation

and Edwards LLC, thus appear to be merely “proxies” for Edwards PVT in this

proceeding.

Third, PVT’s office in Irvine, California is also the same address of Edwards

Corporation and Edwards LLC, as confirmed in the disclosure statements filed by

PVT as a plaintiff in infringement litigation against Medtronic CoreValve LLC (8-

11-cv-00961 C.D. Cal.; 1-12-cv-00023 D. Del.). Ex. 2024, ¶ 4. Thus, substantial

“blurring” of corporate lines is occurring between these Edwards entities. Indeed,

beyond mere “blurring,” it appears that Edwards Corporation has filed these inter

partes review petitions “at the behest of” Edwards PVT—in the same way that

Edwards Corporation is the named “correspondent” on all of Edwards PVT’s

patent assignments (including assignments from Edwards LLC to Edwards PVT).

Ex. 2020.

Based on the forgoing, there is sufficient evidence to raise doubt whether

Petitioner has met its burden in naming all real parties-in-interest. It is Petitioner’s

ultimate burden to prove, by a preponderance of evidence, that Edwards PVT is not

a real party-in-interest in this proceeding.

54

X. CONCLUSION

For the foregoing reasons, Patent Owners respectfully request that the Board

deny the Petition for Inter Partes Review of the ‘530 Patent.

Date: March 15, 2016 Respectfully submitted, /s/ Edward M. Arons Edward M. Arons (PTO No. 44,511) Lead Counsel for Patent Owner

CERTIFICATE OF SERVICE

The undersigned hereby certifies that a copy of the PATENT OWNER’S

PRELIMINARY RESPONSE was served on March 15, 2016, via FEDEX

EXPRESS® directed to counsel of record for petitioner:

W. Todd Baker (Reg. No. 45,265) Oblon, McClelland, Maier and Neustadt, L.L.P.

1940 Duke Street Alexandria, Virginia 22314 Telephone: 703-412-6383 Facsimile: 703-413-2220

/s/ Edward M. Arons Edward M. Arons