neochord, inc

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

NEOCHORD, INC.

Petitioner, v.

UNIVERSITY OF MARLY AND, BALTIMORE

Patent Owner.

Case No.: IPR2016-00208

PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 7,635,386

Petition for Inter Partes Review of U.S. Patent 7,635,386

Table of Contents

Table of Contents ....................................................................................................... i

C 'fi fS . ... ertJ 1cate o erviCe ................................................................................................ 111

List of Evidence and Exhibits Relied Upon in the Petition ..................................... iv

I. INTRODUCTION .................................................................................... 1

II. MANDATORY NOTICES UNDER37 C.P.R. §42.8(a)(1) ................... 2

A. Real Party-In-Interest Under 37 C.F.R. §42.8(b)(l) ........................... 2

B. Related Matters Under 37 C.F.R. §42.8(b)(2) ..................................... 2

c. Lead and Back-Up Counsel Under 37 C.F.R. §42.8(b)(3) .................. 2

D. Service Information Under 37 C.F.R. §42.8(b)(4) ............................... 3

III. PAYMENT OF FEES REQUIRED BY 37 CFR §42.15(a) .................... 3

IV. SUMMARY OF THE '386 PATENT.. .................................................... 3

A. Description of the Claimed Invention of the '386 Patent ................... 3

B. Summary of the Prosecution History of the '386 Patent .................... 4

v. REQUIREMENTS UNDER 37 C.F.R. §42.104 ..................................... 6

A. Grounds for Standing Pursuant to 37 C.F.R. §41.104(a) ................... 7

B. Identification of Challenged Claims and Relief Requested Pursuant to 37 C.F.R. §41.104(b)(l) ..................................................... 7

C. The Specific Art and Statutory Ground(s) on Which the Challenge Is Based Pursuant to 37 C.F.R. §41.104(b)(2) ................... 7

I


D. How the Challenged Claims Are Construed Pursuant to 37 C.F.R. §41.204(b)(3) .......................................................................... 8

1. Medical/physiological terms ...................................................... 9 2 " t" . . I . f h rt" 9 . crea mg an access m an ap1ca reg10n o . a ea ................... .. 3. "percutaneously accessing an apical region of a heart" ........... 11 4. "replacing ... chordae tendinae" .............................................. 12 5. "a suture with one or more leaflets of the heart" ..................... 13 6. "endovascularly via [an antegrade/a retrograde] approach" .... 15

VI. DETAILED EXPLANATION OF PERTINENCE AND MANNER OF APPLYING CITED PRIOR ART TO EVERY CLAIM FOR

WHICH REVIEW IS REQUESTED ..................................................... 17

A. Person of Ordinary Skill in the Art .................................................... 17

B. Applicable Law ..................................................................................... 18

C. U.S. Patent No. 8,465,500 to Speziali .................................................. 20 1. Claims 1, 3, 7-17, 19 and 22-23 are anticipated by Speziali .... 20 2. Claims 2 and 4 are obvious over Speziali ................................ 26 3. Claims 5-6, 18 and 20-21 are obvious over Speziali in

view ofBachman ...................................................................... 27

D. U.S. Patent No. 6,978,176 to Lattouf (Lattouf I) ............................... 30 1. Obviousness over Lattoufl in view of Carpentier ................... 31 2. Obviousness over Lattouf I in view of

Carpentier and Downing .......................................................... 38 3. Obviousness over Lattoufl in view of Bachman ..................... 40 4. Obviousness over Lattoufl in view of Downing ..................... 43

E. U.S. Patent No. 7,871,433 to Lattouf (Lattouf 11) .............................. 47 1. Claims 1, 3, 5-9, 11-15, 17-19 and 22-23 are anticipated by

Lattouf II ................................................................................... 48 2. Remaining dependent claims are obvious over Lattoufii in

view of Downing ...................................................................... 51

F. U.S. Patent No. 6,840,246 to Downing ................................................ 52 1. Obviousness over Downing in view of U.S. Patent No.

6,269,819 to Oz ........................................................................ 53

VII. Conclusion .............................................................................................. 60

11


Certificate of Service

I hereby certify that on November 18, 2015, a copy of this Petition and

Exhibits 1001-1011 were served by Federal Express on the following counsel of

record for the Patent Owner:

Squire PB (NV A/DC Office) 8000 Towers Crescent Drive 14th Floor Vienna, VA 22182-6212

Dated: November 18, 2015 Respectfully submitted,

Brad D. Pedersen Reg. No. 32,432

Attorney for Petitioner

l1I


List of Evidence and Exhibits Relied Upon in the Petition

Exhibit# Name

1001 U.S. Patent No. 7,635,386 (the '386 Patent)

1002 Power of Attorney for Petitioner NeoChord, Inc.

1003 Prosecution History for the '386 Patent

1004 U.S. Patent No. 6,978,176 (Lattouf I)

1005 U.S. Patent No. 6,840,246 (Downing)

1006 U.S. Patent No. 8,465,500 (Speziali)

1007 U.S. Patent No. 7,871,433 to (Lattoufll)

1008 U.S. Publ. No. 2004/0044365 (Bachman)

1009 Cardiac valve surgery - the "French Correction " by Alain Carpentier, M.D., The Journal of Thoracic and Cardiovascular Surgery, Vol. 86, No.3, September 1983 (Carpentier)

1010 U.S. Patent No. 6,269,819 (Oz)

1011 Declaration of Dr. Lishan Aklog

IV


I. INTRODUCTION

U.S. Patent No. 7,635,386 (the '386 Patent) is directed to a cardiac

procedure that creates an access in an apical region of a heart through which

instruments may be inserted to repair a cardiac valve. Ex.1 001, Abstract. The

independent claims of the '386 Patent are directed to implantation of artificial heart

valve chordae tendineae into malfunctioning valve leaflets to restore proper leaflet

function.

As of the earliest priority date ofthe '386 Patent in 2006, minimally invasive

procedures were already known for implantation of artificial chordae to repair a

heart valve through an apical access of a beating heart. The '386 Patent was

improperly allowed by the Examiner only after the independent claims were

amended to recite using sutures with the leaflet as the artificial chordae to repair

the malfunctioning valve and incorrect arguments were made as to the teachings of

the cited prior art relative to these amendments.

Not only does the cited art actually teach what was incorrectly argued by

Patent Owner as missing, other unapplied and/or uncited prior art also establishes

that Petitioner has a reasonable likelihood of prevailing on the grounds presented

in this Petition that at least one of the claims of the '386 Patent is invalid as

anticipated and/or obvious. Petitioner therefore respectfully requests that an Inter

Partes Review (IPR) of the '386 Patent be instituted.

1


II. MANDATORY NOTICES UNDER 37 C.F.R. §42.8(a)(l)

The following mandatory notices under the Rules are provided.

A. Real Party-In-Interest Under 37 C.F.R. §42.8(b)(l)

Petitioner certifies and submits that the real party-in-interest for this Petition

is NeoChord, Inc., a Minnesota corporation. Ex.l 002.

B. Related Matters Under 37 C.F.R. §42.8(b)(2)

Petitioner is unaware of any other judicial or administrative matter that

would affect, or be affected by, a decision in this proceeding.

C. Lead and Back-Up Counsel Under 37 C.F.R. §42.8(b)(3)

Petitioner designates lead and backup counsel as:

Lead Counsel Backup Counsel

Brad D. Pedersen Eric H. Chadwick, Chad J. Wickman

Reg. No. 32,432 Reg. No. 41,664, Reg. No. 58,356

Patterson Thuente Pedersen, P .A. Patterson Thuente Pedersen, P.A.

80 South 81h Street, Suite 4800 80 South 81

h Street, Suite 4800

Minneapolis, MN 55402 Minneapolis, MN 55402

Phone: 612.349.5774 Phone: 612.349.5740

Fax: 612.349.9266 [email protected],

[email protected] [email protected]

2


D. Service Information Under 37 C.F.R. §42.8(b)(4)

Papers concerning this matter should be served on lead and backup counsel

as designated in Section II( C), with a courtesy e-mail copy to: [email protected].

Petitioner hereby consents to email service of any papers in this proceeding.

III. PAYMENT OF FEES REQUIRED BY 37 CFR §42.15(a)

Payment of the fees is made concurrently with the filing of this Petition via

the USPTO EFS payment system. The Director is authorized to charge any

additional fees that might be due in connection with this Petition to Deposit

Account No. 16-0631.

IV. SUMMARY OF THE '386 PATENT

A. Description of the Claimed Invention of the '386 Patent

The two independent claims (1 and 19) of the '386 Patent are each directed

to a method of repairing heart valves. The claims recite: (i) creating an access in an

apical region of the heart through which a device is inserted, and (ii) using that

device to repair the heart valve by replacing chordae tendineae and implanting

artificial chordae tendineae that comprise a suture with one or more leaflets of the

heart. Ex.lOOl, 20:41-52,22:6-14.

The result of this method is shown in Figure 9 of the '386 Patent, which

depicts a suture (990) inserted through a leaflet (980) and anchored adjacent the

apical region (902) at the apex of the heart (900). !d., 13:60-62.

3


VA"'-990

900~

FIG. 9

B. Summary of the Prosecution History of the '386 Patent

The '386 Patent issued from U.S. Application No. 11/683,282, filed as a

non-provisional patent application on March 7, 2007, and claiming priority to U.S.

Provisional Application No. 60/780,521, filed March 7, 2006. Ex.lOOl. The '386

Patent is governed by U.S. patent laws prior to the America Invents Act (pre-AlA).

The prosecution of the '386 Patent included only a single Office Action.

Ex.1003, pp.21-26. The independent claims and some dependent claims were

initially rejected as being anticipated by U.S. Patent No. 6,978,176 (Lattouf I). The

remaining dependent claims were rejected as being obvious over Lattouf I in view

of U.S. Patent No. 6,840,246 (Downing) or U.S. Patent No. 7,291,168 to Macoviak

et al.

4


Patent Owner responded with an Amendment cancelling dependent claims 2

and 25 and amending independent claim 1 and independent claim 21 (issued as

independent claim 19). Ex.1003, pp.6-10. Language was added to the independent

claims to recite that repairing the valve comprises replacing chordae and

implanting artificial chordae that comprise a suture with leaflets of the heart. Claim

1 as amended reads:

I. (Currently Amended) A method for repairing a defective mitral or

tricuspid valve, comprising:

creating an access in anthe ap6* apical region of a heart through

which a defective cardiac valve is accessed;

introducing a device through said access; and

repairing said cardiac valve by use of said device,

wherein the repairing comprises

replacing one or more chordae tendineae, and

using said device to implant one or more artificial

chordae tendineae, and

wherein the one or more artificial chordae comprises a suture with

one or more leaflets of the heart.

!d., p.6.

Patent Owner argued that the distinguishing feature of the amended claims

over the cited art was the use of a suture with a valve leaflet:

Lattouf fails to disclose or suggest that the strand includes a suture in

the leaflets. Accordingly, Lattouf fails to disclose or suggest, at least,

"wherein the one or more artificial chordae comprises a suture with

5


one or more leaflets of the heart," as recited in independent claim I

and similarly recited in independent claim 21. In contrast, Lattouf

refers to the strand having one end secured to the clip, as discussed

above. Lattouf refers to suturing the strand with only the pledget, as

mentioned above, not the leaflets.

!d., pp.l3-I4.

With respect to the secondary reference Downing, Patent Owner cited solely

to an embodiment for repair "of a mitral valve uses staples which may be banded

together with a strip of material," and argued that Downing also did not teach the

limitations urged as missing from Lattouf. !d., pp.l6-I7. Patent Owner concluded

that, "Downing is silent as to teaching the particular features associated with the

artificial chordae of independent claims I and 21." !d., p.17.

Patent Owner did not separately argue for the patentability of any dependent

claims. Id., p.I6. A Notice of Allowance was mailed in response to the

Amendment, but no Reasons for Allowance were provided. !d., pp.l-4.

The entire basis of Patent Owner's argument for patentability that resulted in

allowance of the claims of the '386 Patent was that neither Lattouf I nor Downing

taught using a suture with the valve leaflet as an artificial chordae.

V. REQUIREMENTS UNDER 37 C.F.R. §42.104

As set forth below, Petitioner submits that each requirement for institution of

an IPR of the '386 Patent is satisfied.

6


A. Grounds for Standing Pursuant to 37 C.F.R. §41.104(a)

Petitioner certifies and submits that the '386 Patent is available for IPR, and

that Petitioner is not barred or estopped from filing this Petition. Ex.1 002.

B. Identification of Challenged Claims and Relief Requested Pursuant to 37 C.F.R. §41.104(b)(l)

The precise relief requested by Petitioner is that claims 1-23 of the '386

Patent be found unpatentable.

C. The Specific Art and Statutory Ground(s) on Which the Challenge Is Based Pursuant to 37 C.F.R. §41.104(b)(2)

Petitioner requests an IPR of the '386 Patent be instituted for any/all of the

following grounds ofunpatentability under pre-AlA 35 U.S.C. §102 (anticipation)

and pre-AlA 35 U.S.C. § 103 (obviousness):

Ground 1- U.S. Patent No. 8,465,500 (Speziali)

lA. Claims 1, 3, 7-17, 19 and 22-23 are anticipated by Speziali

lB. Claims 2 and 4 are obvious over Speziali

lC. Claims 5-6, 18 and 20-21 are obvious over Speziali in view of

U.S. Publ. No. 2004/0044365 (Bachman).

Ground 2- U.S Patent No. 6,978,176 (Lattoufl)

2A. Claims 1-9, 11-15, 17-19 and 22-23 are obvious over Lattoufl

in view of Cardiac valve surgery- the "French Correction" by

Alain Carpentier, M.D., The Journal of Thoracic and

7


Cardiovascular Surgery, Vol. 86, No. 3, September 1983

(Carpentier)

2B. Claims 10, 16 and 20-21 are obvious over Lattoufl in view of

Carpentier and further in view of US Patent No. 6,840,246

(Downing)

2C. Claims 1, 2-9, 11, 14-15 and 17-23 are obvious over Lattoufl

in view of U.S. Pub!. No. 2004/0044365 (Bachman)

2D. Claims 1-23 are obvious over Lattoufl in view of Downing

Ground 3- U.S. Patent No. 7,871,433 (Lattoufll)

3A. Claims 1, 3, 6-9, 11-15, 17-19 and 22-23 are anticipated by

Lattoufll

3B. Claims 2, 4, 10, 16 and 20-21 are obvious over Lattouf II in

view of Downing

Ground 4- U.S Patent No. 6,840,246 (Downing)

4A. Claims 1-13 and 19-23 are obvious over Downing in view of

U.S. Patent No. 6,269,819 (Oz)

4B. Claims 14-18 are obvious over Downing in view of Oz and

further in view ofLattoufi

D. How the Challenged Claims Are Construed Pursuant to 37 C.F.R. §41.204(b )(3)

A claim in IPR is given the "broadest reasonable construction in light of the

8


specification." 37 C.F.R. §41.200(b); In re Cuozzo Speed Techs., 778 F.3d 1271,

1279 (Fed. Cir. 2015). To the extent that may be necessary under this standard,

Petitioner has set forth the broadest reasonable interpretation (BRI construction) of

certain of the claim terms below. 1

1. Medical/physiological terms

Various claims of the '386 Patent recite a number of medical and

physiological terminology that Petitioner submits need no specific BRI

construction because such terms would be readily understood and given their plain

and ordinary meaning. Such terms have been defined in the Aklog Declaration for

the purpose of setting forth an understanding of the technical background of the

'386 Patent. Ex.1011, ~15-29.

2. "creating an access in an apical region of a heart"

Claim 1 of the '386 Patent recites "creating an access in an apical region of

a heart through which a defective cardiac valve is accessed." For BRI construction

an "apical region of a heart" encompasses a region of the heart near its apex, but

this terminology does specify any particular anatomical parts or features of this

region of the heart. Ex.1 011, ~~16 and 40. For BRI construction, the term "access"

in this claim limitation is used as a noun that defines an opening in the apical

1All discussions in the Petition of BRI construction are presumed to be as

understood by a person of ordinary skill in the art at the time of invention.

9


region of the heart "through which a defective cardiac valve is accessed" as

claimed later in the claim. Ex. lOll, ~17. Fig. 5 of the '386 Patent is identified as

illustrating "an access created in the apex region of the heart." Ex.1 001, 10:8-17.

As shown below, Fig. 5 depicts the "access" of claim 1 as an entry (504). The entry

(504) is described as being made by "an incision into the apical region of the

appropriate ventricle (e.g., 520) of the heart." !d.

FIG. 5

520

\~504 J:1"552 '\..550

While there are natural openmgs m the supenor regions of the heart

constituting the four heart valves and great vessels, there are no natural openings in

the apical region of the heart. Ex. lOll, ~42. Therefore, the use of the term "access"

in claim 1 must be construed consistent with the specification of the '386 Patent to

be an entry surgically created by an incision or puncture in the wall of the heart.

Ex. lOll, ~43. Accordingly, the BRI construction of "creating an access in an

10


apical region of a heart" in claim 1 is "creating an incision or puncture in a wall of

the heart in the region near the apex of the heart." Ex.1 011, ~44.

3. "percutaneously accessing an apical region of a heart"

Claim 19 of the '386 Patent recites "percutaneously accessing an apical

region of a heart with a catheter-based device." For BRI construction, the

terminology "percutaneously accessing" is used as a verb phrase that defines,

consistent with the remainder of claim 19, the process of obtaining access through

the skin to a chamber of the heart with a catheter-based device for "repairing a

cardiac valve by use of said device" as claimed later in the claim. Ex.l 011, ~45.

The '386 Patent discusses several embodiments that are referred to as

percutaneous, including a direct needle access method. Ex.1001, 6:54-7:50. There

is also a brief discussion of a "completely percutaneous" embodiment in which

"[t]hese methods may also be performed in a completely percutaneous manner; for

instance via the femoral or internal jugular veins, via the inter-atrial septum (trans

septal) and then into the left atrium, or via a retrograde approach (femoral artery,

across aortic valve)." Ex.1001, 6:27-31. This passage, and dependent claims 20

and 21, seem to describe an endovascular technique in which access is primarily

obtained by routing the catheter through the vascular system instead of by direct

needle access to the heart; however, there are no figures in the '386 Patent showing

this "completely percutaneous" embodiment. Ex.1011, ~46.

11


Unlike the construction of claim 1, there is nothing in claim 19 that requires

the accessing method to be limited to creating an incision in a wall of the heart.

There is nothing in the claim language of claim 19 that restricts the accessing

method to a particular embodiment of the method of accessing to either direct or

endovascular percutaneous accessing of the heart, let alone restricting the

accessing method to a method of direct percutaneous access through a wall of the

heart in the apical region. Ex.1 011, ~46. Accordingly, the BRI construction of

"percutaneously accessing an apical region of a heart" in claim 19 as properly

construed and understood by a person skilled in the art is "the process of obtaining

access through the skin to a region of a ventricular chamber of the heart near the

apex of the heart." Id.

4. "replacing ... chordae tendinae"

Independent claim 1 recites "replacing one or more chordae tendinae" and

independent claim 19 recites "replacing at least one chordae tendinae." The '386

Patent describes that a damaged chordae tendinae is "replaced" by inserting a

suture as a replacement chordae. Jd., 13:42-45 ("Once fully implanted, the

suture(s) acts as a neo-cord, replacing damaged and ruptured chordae tendinae and

restoring proper leaflet function.")

There is no express teaching in the '386 Patent that the "replaced" native

chordae is physically removed from the valve. Id., 10:60-67 ("[I]f one or more of

12


the chordae tendinae are ruptured, elongated or fused, they can be replaced in

accordance with the methods disclosed herein, with one or more artificial cords or

by transferring redundant cords from another leaflet section. Shrunken or fused

cords can be released or split by precisely cutting the affected cords, and even the

papillary muscles, themselves, can be shortened to correct prolapse from multiple

elongated cords."). Rather, for purposes of the BRI construction, it is not the

physical structure, but the function of the pathologic chordae that is replaced.

Ex.1 011, IJIJ47-48. Accordingly, to the extent it can be understood under the claim

construction standard used for this Petition, the BRI construction of the

terminology "replacing ... chordae tendinae" as used in the claims of the '386

Patent means "replacing the function of the native chordae tendineae with an

artificial chordae tendineae. "2 Ex.1 011, IJ49.

5. "a suture with one or more leaflets of the heart"

2Petitioner notes that claim 1 recites both "replacing one or more chordae

tendineae, and using said device to implant one or more artificial chordae

tendineae" (emphasis added). Although not at issue in this proceeding, the

presence of the word "and" presents 35 U.S.C. § 112 issues in view of the seeming

redundancy of the limitations. For purposes of this Petition, these limitations have

been construed as indicated without waiving any right to challenge the validity of

the claims on this basis in any subsequent proceeding.

13


Both independent claims 1 and 19 of the '386 Patent recite that the

implanted artificial/replacement chordae "comprises a suture with one or more

leaflets of the heart." The specification of the '3 86 Patent does not define or even

use the phrase "a suture with one or more leaflets."3 However, Patent Owner

argued extensively regarding this limitation in the one Office Action response

submitted during prosecution of the '386 Patent.

Patent Owner relied on this limitation as the only basis for patentability of

the claims during prosecution. Patent Owner distinguished this limitation from

Lattouf I by arguing that Lattouf I only taught connecting a suture to a leaflet clip

that is connected to a leaflet or to a pledget. Patent Owner further argued that

neither of these types of connections in Lattouf I meet this limitation. Ex.1 003,

pp.l3-14. Patent Owner therefore is presumed, solely for purposes of this Petition,

3 Petitioner notes that this limitation is ambiguous and unclear in that the use of

the word "with" implies that the artificial chordae comprises both the suture and

the leaflet. Although not at issue in this proceeding, the use of the word "with"

presents 35 U.S.C. § 112 issues in view of the plain reading of the limitation. For

purposes of this Petition, this limitation has been construed as indicated without

waiving any right to challenge the validity of the claims on this basis in any

subsequent proceeding.

14


to have defined "a suture with one or more leaflets" as requiring the suture to be

inserted directly through the leaflet tissue, rather than to another structure that was

connected directly to a leaflet. This interpretation is consistent with the

specification of the '386 Patent, which describes grasping a leaflet and inserting a

needle through the leaflet to implant a suture through the leaflet tissue. Ex.lOOl,

12:2-13:46 and Fig. 9.

Accordingly, the BRI construction of the phrase "a suture with one or more

leaflets of the heart" as used in the claims of the '386 Patent means "a suture

inserted directly through the tissue of a native leaflet of a heart and not indirectly

through a clip or other device that is in turn attached to the native leaflet."

Ex.1011,~50.

6. "endovascularly via [an antegrade/a retrograde] approach"

Claims 20 and 21 of the '386 Patent recite that the step of accessing in claim

19 is performed "endovascularly."4 One of ordinary skill in the art would

4 Petitioner notes that this limitation in both claims 20 and 21 may be indefinite

and/or not enabled because it is not feasible to endovascularly access the heart

through the apical region if the term "accessing" is construed consistent with the

interpretation of the term "access" in claim 1. Ex. 1011, ~51. Although not at issue

in this proceeding, the use of the word "endovascularly" presents 35 U.S.C. § 112

issues for these reasons. For purposes of this Petition, this limitation has been

15


understand "endovascular" in this context as referring to using a catheter based

device routed through a vascular access path for accessing a target within the

patient. Ex.1 011, ~23.

Claim 20 of the '386 Patent recites that the endovascular access is "via an

antegrade approach." Antegrade means along a direction of blood flow as the

catheter approaches the target anatomical structure. Ex. lOll, ~52. The tricuspid

valve can be repaired via antegrade access from the femoral vein, through the vena

cava and into the right atrium. !d. The only discussion of an antegrade approach in

the '386 Patent describes subsequent trans-septal access into the left atrium for

repair of the mitral valve. Id.; Ex. 1001, 11:43-49. Accordingly, the BRl

construction of "endovascularly via an antegrade approach" means "using a

catheter based device that approaches the valve from the atrial side." Ex.l 011, ~52.

Claim 21 of the '386 Patent recites that the endovascular access is "via a

retrograde approach." Retrograde means opposite of a direction of blood flow as

the catheter approaches the target anatomical structure. Ex.1011, ~53. The only

discussion of a retrograde approach in the '386 Patent describes an atrial access

path through the aorta and across the aortic valve to the left chambers of the heart

for repair of the mitral valve. !d.; Ex. 1001, 11:49-53. Repair of the tricuspid valve

construed as indicated without waiving any right to challenge the validity of the

claims on this basis in any subsequent proceeding.

16


via retrograde access is not performed because direct percutaneous access to the

pulmonary arterial system is not practical. Ex.1011, ~53. Accordingly, the BRI

construction of "endovascularly via a retrograde approach" means "using a

catheter based device that approaches the valve from the ventricular side." Ex.

1011, ~53.

VI. DETAILED EXPLANATION OF PERTINENCE AND MANNER OF APPLYING CITED PRIOR ART TO EVERY CLAIM FOR WHICH REVIEW IS REQUESTED

Patent Owner essentially conceded in the original prosecution of the '386

Patent that Lattoufl teaches all limitations of the independent claims except that

repairing the cardiac valve comprises replacing one or more chordae tendineae by

implanting one or more artificial chordae tendineae as a suture "with" or through

one or more leaflets of the heart. Ex. 1003, pp. 11-20. However, Patent Owner

incorrectly interpreted Lattouf I because the Lattouf references clearly and

expressly disclose that sutures can be inserted into a leaflet as artificial chordae.

Ex. lOll, ~50 and 65; Ex.1004, 3:51-62; Ex.1007, 4:5-15. In addition, Speziali,

Downing, Bachman and Carpentier discussed herein are all prior art references that

teach repairing a heart valve leaflet with an artificial chordae that comprises a

suture onto one or more leaflets of the heart. Ex. 1011, ~55, 66, 72 and 75.

A. Person of Ordinary Skill in the Art

17


Petitioner proposes that a person of ordinary skill in the art in the field of the

'386 Patent at the time of invention would be a cardiac surgeon having substantial

experience performing mitral valve repair procedures. Ex.1 011, IJ12-14.

B. Applicable Law

1. Anticipation (pre-AlA 35 U.S.C. §102)

Under pre-AlA Section 102, each and every element of a claim, as properly

construed, must be found, either explicitly or inherently in a single prior art

reference, as arranged in the claim. To anticipate a claim, the single reference also

must provide an enabling disclosure, with enough information to enable a person

having ordinary skill in the art at the time of invention to reproduce the claimed

invention without undue experimentation. Bristol-Myers Squibb Co. v. Ben Venue

Labs., Inc., 246 F.3d 1368, 1374 (Fed. Cir. 2001).

2. Obviousness (pre-AlA 35 U.S.C. §103)

A patent claim is invalid under pre-AlA 35 U.S.C. §103 if the differences

between the claimed invention and the prior art are such that the subject matter as a

whole would have been obvious at the time the invention was made to a person

having ordinary skill in the art to which the subject matter pertains.5 Graham v.

5 All discussions in the Petition of "one skilled in the art" in the context of

anticipation or obviousness are presumed to be as understood by a person of

18

Petition for Inter Partes Review ofU.S. Patent 7,635,386

John Deere, 383 U.S. 1, 17-18 (1966). The determination of obviousness is based

on the scope and content of the prior art, the differences between the prior art and

the claim, the level of ordinary skill in the art at the relevant time, and any

objective evidence (secondary indicia) of non-obviousness, to the extent such

evidence exists. !d. at 13.

"[R]ejections on obviousness grounds cannot be sustained by mere

conclusory statements; instead, there must be some articulated reasoning with

some rational underpinning to support the legal conclusion of obviousness." In re

Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). "[O]bviousness concerns whether a

skilled artisan not only could have made but would have been motivated to make

the combinations or modifications of prior art to arrive at the claimed invention."

Belden Inc. v. Berk-Tek LLC, Nos. 2014-1575, -1576. Slip. Op. at 13 (Fed. Cir.

Nov. 5, 2015) (emphasis in original). As the Supreme Court has set forth, this

articulated reasoning can include the application of routine skill by one skilled in

the art when there are a finite number of known solutions.

"When there is a design need or market pressure to solve a problem

and there are a finite number of identified, predictable solutions, a

person of ordinary skill in the art has good reason to pursue the known

ordinary skill m the art to which the subject matter pertains at the time of

invention.

19


options within his or her technical grasp. If this leads to the

anticipated success, it is likely the product not of innovation but of

ordinary skill and common sense."

KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1740-1741 (2007).

C. U.S. Patent No. 8,465,500 to Speziali

U.S. Patent No. 8,465,500 to Speziali was filed July 11, 2007, as a national

stage of PCT Application No. PCT/US06/01699 filed January 19, 2006, which

claimed priority to U.S. Provisional Application No. 60/645,677 filed January 21,

2005. Ex.l 011, ~54. Speziali qualifies as prior art to the '3 86 Patent under pre-AlA

35 U.S.C. §102(e). Ex.l003, p.33. Although the published PCT application related

to the Speziali6 reference was cited by the Patent Owner in an Information

Disclosure Statement during prosecution, it was never discussed or considered on

the record. The Examiner of the '386 Patent apparently overlooked the teachings in

this reference. Speziali explicitly teaches an essentially identical heart valve repair

technique to that claimed in the independent claims of the '386 Patent.

1. Claims 1, 3, 7-17, 19 and 22-23 are anticipated by Speziali

As discussed above, to the extent they can be understood for purposes of this

Petition, the independent claims ofthe '386 Patent essentially require only two key

aspects: (i) introducing a device into the apical region of the heart; and (ii)

repairing a heart valve with the device by inserting a suture directly through the

6 Petitioner is the exclusive licensee of Speziali.

20


tissue of a native leaflet of the heart as an artificial replacement chordae tendineae.

Speziali expressly discloses each of these limitations.

More specifically, Speziali discloses a method m which "[a] double-

pledgeted purse-string suture is placed on the apex of the left ventricle and a stab

incision is made at that location" and "[t]he surgical instrument 10 is inserted

through this incision, into the left ventricular chamber 14 of the beating heart," and

therefore expressly discloses accessing the apical region of the heart as claimed.

Ex.1 006, 5:14-18 (emphasis added). Ex. 1011, ~55.

FIG. 78

apical region of the heart

Fig. 7B of the '386 Patent (left- anterior view) and Fig. 2 of Speziali (right- superior view),

each showing introduction of an instrument through the apex of the heart

Speziali further discloses enacting a repair of the mitral valve via this access

as "the instrument 10 may be used to grasp a prolapsing segment of the mitral

21


valve 16 and an artificial charda 18 may be secured to its free edge" with a needle

that is "then retracted to pull the the (sic) looped suture 18 through the puncture

opening in the leaflet." Id., 5:19-21 and 6:61-62. Figure 9D of Speziali, for

example, clearly shows the allegedly inventive feature of the claims of the '386

Patent of"a suture (18 in Figure 9D) with one or more leaflets (16 in Figure 9D) of

the heart." Ex. 1011, ~42.

native leaflet tissue

16 \r----J suture through leaflet

162

FIG. 9D FIG. BC

Figure 8C of the '386 Patent (left) and Figure 9D ofSpeziali (right), each showing a suture through a leaflet

As set forth in detail in the charts below, Speziali anticipates independent

claims 1 and 19 ofthe '386 Patent. Ex. 1011, ~55.

1[A]. A method for repairing a defective mitral or tricuspid valve, compnsmg:

Speziali discloses that "the instrument 10 may be used to grasp a prolapsing segment of the mitral valve 16 and an artificial chorda 18 may be secured to its free edge." (5:19-21.) (see 1[C] below).

22


[B] creating an access in Speziali discloses that "[a] double-pledgeted purse-an apical region of a string suture is placed on the apex of the left ventricle heart through which a 12 and a stab incision is made at that location. The defective cardiac valve is surgical instrument 10 is inserted through this incision, accessed; introducing a into the left ventricular chamber 14 of the beating device through said heart." (5: 14-18.) access; and [C] repairing said cardiac Speziali discloses that "the instrument 10 may be used valve by use of said to grasp a prolapsing segment of the mitral valve 16 device, wherein the and an artificial chorda may be secured to its free repairing comprises edge." (5: 19-21.) replacing one or more chordae tendineae, and using said device to implant one or more artificial chordae tendineae, [D] and wherein the one Speziali discloses that "[t]he distal end of the shaft 100 or more artificial chordae also contains an artificial chorda, or suture 18, that is to comprises a suture with be deployed in the patient's heart" and that "[t]he one or more leaflets of needle 180 is then retracted to pull the the (sic) looped the heart. suture 18 through the puncture opening in the leaflet

18." (6:10-12 and 61-62.) 19[A]. A method for Speziali discloses that "the instrument 10 may be used treating a defective to grasp a prolapsing segment of the mitral valve 16 mitral or tricuspid valve, and an artificial chorda 18 may be secured to its free comprising: edge." (5:19-21.) [B] percutaneously Speziali discloses that "[a] double-pledgeted purse-accessing an apical string suture is placed on the apex of the left ventricle region of a heart with a 12 and a stab incision is made at that location. The catheter-based device; surgical instrument 10 is inserted through this incision, and into the left ventricular chamber 14 of the beating heart.

"(5:14-18.) [C] repairing a cardiac Speziali discloses that "the instrument 10 may be used valve by use of said to grasp a prolapsing segment ofthe mitral valve 16 device, wherein the and an artificial chorda may be secured to its free repairing comprises edge." (5: 19-21.) replacing at least one chordae tendineae, and [D] wherein the replaced Speziali discloses that "[t]he distal end of the shaft 100

23


chordae tendineae comprises a suture with one or more leaflets of the heart.

also contains an artificial chorda, or suture I8, that is to be deployed in the patient's heart" and that "[t]he needle I80 is then retracted to pull the the (sic) looped suture 18 through the puncture opening in the leaflet 18." (6:10-12 and 61-62.))

Speziali further anticipates at least dependent claims 3, 7-17 and 22-23.

Ex. lOll, ~56. Claims 3 recites that the device is a suturing or stapling device, and

Speziali also discloses a suturing device. Ex.1006, 6:10-12; Ex.l OII, ~56.

3. The method of claim I, wherein the device is a suturing or stapling device.

Speziali discloses that "[t]he distal end of the shaft I 00 also contains an artificial chorda, or suture I8, that is to be deployed in the patient's heart." (6:IOI2.)

Claim 7 recites that the procedure is performed on a beating heart and claim

8 recites that the procedure is minimally invasive, each of which is also disclosed

in Speziali. Ex.I006, 2:67-3:1; Ex.1011,~56.

7. The method of claim Speziali discloses "a minimally invasive thoracoscopic I, wherein the repair is repair of heart valves while the heart is beating." (2:67 performed while the -3:1.) heart is beating. 8. The method of claim Speziali discloses "a minimally invasive thoracoscopic I, wherein the method is repair of heart valves while the heart is beating." (2:67 a minimally invasive -3:1.) procedure.

Claims 9 and I 0 recite visualization techniques, endoscopy and sonography

or direct transblood visualization, respectively, that are also disclosed in Speziali.

Ex.I006, 3:11-13 (claim 9) and 5:9-II (claim 10); Ex.IOll, ~~ 19-21,56.

!9. The method of claim I Speziali discloses that "the instrument includes fiber

24


I , wherein the method optics which provide direct visual indication that the comprises the use of valve leaflet is properly grasped." (3:11-13.) endoscopy. I 0. The method of claim Speziali teaches that "[g]uidance of the intracardiac I, wherein the procedure is provided by a combination of introduction of the transesophageal or intravascular echocardiography." device is performed in (5:9-11.) conjunction with sonography or direct transblood visualization.

Claims 11-I7 and 23 each recite various aspects of anchoring and tensioning

the inserted sutures that are disclosed in Speziali. Ex. I 006, (3: 8-10 (claims Il, 15-

17, 23); 5: 4I-42 (claims 12-13); 7: 27-28 (claim I4); Ex.lOli, ~43. With respect

to claims I2 and 14 in particular, Speziali discloses anchoring to a papillary

muscle, which is internal to the heart (claim 12) and also to the outside of the heart,

which is the epicardium (claim I4). Ex.I011, ~22, 56. Claim 22 recites that the

apical region of the heart is accessed transmyocardially, i.e., through the heart wall,

which is disclosed in Speziali. Ex.1006, 3: I-3; Ex.lOII, ~26, 56.

11. The method of claim I, wherein Speziali discloses that "the suture is tied said repairing comprises: anchoring off at the apex of the heart." (3:8-9.) the one or more artificial chordae to a tissue in the apical region of the heart. 12. The method of claim 11, wherein Speziali discloses that "the chorda I8 can the apical tissue is internal to the be anchored to a papillary muscle in the heart. heart." (5:4I-42.) 13. The method of claim 11, wherein Speziali discloses that "the chorda 18 can the apical tissue is a papillary muscle, be anchored to a papillary muscle in the a papillary connective tissue or an heart." (5:41-42.) endocardial tissue in the lower ventricle. 14. The method of claim 11, wherein Speziali discloses that "[t]he suture 18 is

25


the apical tissue is the epicardium. secured to the outside of the heart apex." (7:27-28.)

15. The method of claim 11, further Speziali discloses that "the suture is tied comprising determining an optimal off at the apex of the heart after adjusting configuration7 of the one or more its tension for optimal valve operation." artificial chordae before anchoring the (3:8-10.) artificial chordae. 16. The method of claim 15, wherein Speziali discloses use of "an ultrasonic the determining comprises the use of imaging system." (3:8-10.) sonic guidance. 17. The method of claim 15, wherein Speziali discloses that "the suture is tied the artificial chordae are anchored to off at the apex of the heart after adjusting the apical tissue subsequent to said its tension for optimal valve operation with determination. an ultrasonic imaging system." (3:8-10.) 22. The method of claim 19, wherein Speziali teaches "inserting an instrument said accessing is done via direct through the subject's chest wall and access through a transmyocardial through the heart wall." (3:1-3.) approach. 23. The method of claim 19, wherein Speziali discloses that "the suture is tied the replacing comprises anchoring a off at the apex of the heart." (3:8-9.) neochord to the apical region.

2. Claims 2 and 4 are obvious over Speziali

Claims 2 and 4 recite additional procedures that can be performed such as

7 Petitioner notes that the phrase "optimal configuration" appears ambiguous in

view of the recitation of "optimal arrangement, length, placement and

configuration" in the specification. Ex.lOOl, 14:6-9. Although not at issue in this

proceeding, the use of the term "optimal configuration" presents 35 U.S.C. § 112

issues for these reasons. For purposes of this Petition and this limitation in this

ground, the term "optimal configuration" does not need to be defined as the exact

same term is used in Spezialli.

26


leaflet resection (claim 2) and annuloplasty (claim 4), each of which is discussed in

the background section of Speziali as procedures that are known in the art among a

finite number of mitral valve repair techniques. Ex.1 006, 1 : 5 8-61; Ex.1 011, ~57.

One skilled in the art would have known of these additional mitral valve repair

procedures. !d. Based on the professional judgment of one of skilled in the art as to

whether or not to employ these techniques on a given patient where there is a

reasonable expectation of success with such known techniques, it would have been

obvious to one skilled in the art to utilize either of these techniques as additional

procedures together with the method of claim 1. !d. The fact that these techniques

are favorably discussed in the background section of Speziali provides a further

rationale for why one skilled in the art would employ a combination of either of

these techniques with the various embodiments as described in the description

section of Speziali. !d.

2. The method of claim Speziali discloses that"[ v ]arious surgical techniques 1, wherein the repairing may be used to repair a diseased or damaged valve, comprises resecting one including ... quadrangular resection (narrowing the or more leaflets. valve leaflets)." (1 :58-61.) 4. The method of claim Speziali discloses that"[ v ]arious surgical techniques 1, wherein the repairing may be used to repair a diseased or damaged valve, comprises annuloplasty. including annuloplasty (contracting the valve

annulus)." (1 :58-61.)

3. Claims 5-6, 18 and 20-21 are obvious over Speziali in view of Bachman

U.S. Patent Application Publication No. 2004/0044365 to Bachman

27


("Bachman") was published March 4, 2004 and qualifies as prior art to the '386

Patent under pre-AlA 35 U.S.C. §102(b). Ex. lOll, ~58. The additional limitations

recited in dependent claims 5-6, 18 and 20-21 of the '386 Patent generally relate to

other types of valve repair procedures and surgical access approaches that can and

would often be employed with the methods disclosed in the '386 Patent that are not

expressly disclosed in Speziali. For example, claim 6 recites that "the repairing

comprises performing a bow-tie Alfieri procedure" and claim 20 recites that "said

accessing is done endovascularly." Bachman discloses each of these additional

limitations. Ex.l 008, [0006] (claim 5), [0009] (claim 6), [0042] (claim 18) and

[0046] (claims 20-21); Ex. lOll, ~59.

Bachman teaches that these repair procedures are well known in the field as

alternative and/or complimentary repair methods (claims 5 and 6), manipulation

method (claim 18), and endovascular access approaches (claims 20 and 21) are

well known and each can be accomplished with catheter-based devices such as the

device of Speziali. Ex. lOll, ~59. The underlying objective of a minimally invasive

catheter-based approach is to effectuate a repair that mimics the techniques

employed in open procedures. Ex.l 011, ~61. One skilled in the art would use

professional judgment to determine whether any of these procedures would be

suitable to utilize in the case of a given patient when there is a reasonable

expectation of success with such known technique for that patient from among the

28


finite number of valve repair options. Ex.l 011, ~~60-61. It therefore would have

been obvious to supplement the technique of Speziali to perform these known

alternative mitral valve repair procedures to more closely mimic access the heart

via an open access by incorporating these known alternative techniques together

with the method of claim 1. !d.

5. The method of claim Bachman discloses that "valvular remodeling is 1, wherein the repairing accomplished by implanting a prosthetic ring comprises stapling or ("annuloplasty ring") into the valve annulus to reduce suturing the annulus to and/or stabilize the structure of the annulus. create an annuloplasty Annuloplasty rings are typically constructed of a "effect". resilient core covered with a fabric sewing material.

Annuloplasty procedures can be performed alone, or they can be performed in conjunction with other procedures such as leaflet repair. Although annuloplasty procedures have become popular and well accepted, reshaping the surrounding annulus and traditional leaflet repairs do not always lead to optimum leaflet coaptation." (Para. [0006].)

6. The method of claim Bachman discloses that "[t]he bow-tie technique has 1 , wherein the repairing proved to be a viable alternative for treating otherwise comprises performing a incompetent heart valves" and depicts the technique bow-tie Alfieri as performed by the disclosed repair device. (Para. procedure. [0007]- [0009] and FIGS 12-13.) 18. The method of claim Bachman discloses a device with a vacuum port used 1, wherein the repairing such that "the tissue portion 72 located proximate the comprises the vacuum port 52 is grasped and retained by the application of a vacuum. vacuum force" so that a suture can be inserted

through the tissue portion (leaflet). (Para. [0042].) 20. The method of claim Bachman discloses "[t]hose skilled in the art will 19, wherein said appreciate that the mitral valve repair device 10 ofthe accessing is done present invention may approach the cusp of the mitral endovascularly via an valve from an antegrade position or from a retrograde antegrade approach. position as desired by the user. For a retrograde

approach, the user attaches the repair device 10 to the and guidewire emerging from the left femoral artery. The

29


21. The method of claim 19, wherein said accessing is done endovascularly via a retrograde approach.

device is then advanced along the guidewire to a position proximate the retrograde aspect of the mitral valve. The engagement tip 16 of the mitral valve repair device 10 may be positioned proximate the tissue portion 72 of the mitral valve. Once suitably positioned, the tip actuator 22 positioned on the handle 12 may be actuated, thereby resulting in the extendable tip 48 of the engagement tip 16 extending distally from the fastener deployment housing 46." (Para. [0042].)

D. U.S. Patent No. 6,978,176 to Lattouf (Lattouf I)

Lattouf I was first published July 10, 2003, and is therefore prior art to the

'386 Patent under pre-AlA 35 U.S.C. § 102(b). Lattouf I was the primary reference

applied against the claims of the '386 Patent during prosecution and was found by

the Examiner to teach elements lA-lC of elements lA-lD as recited in the claim

charts in this Petition. Ex.l003, p.23. During prosecution of the '386 Patent, the

Patent Owner argued that Lattouf I fails to teach element 1D of the claim of a

suture through a valve leaflet as an artificial replacement chordate. Ex.1 003, pp.12-

14. As discussed in section VI(D)(l), infra, these assertions are demonstrably

incorrect. Lattouf I does teach a strand [suture] through a valve leaflet as an

artificial replacement chordate. Ex.l004, 3:58-62; Ex.1011, ~64 and 79.

Even if the Patent Owner arguments were to be accepted,8 the prior art is

8In Section D, Petitioner presents reasons to "modify" Lattouf I in view of

the additional prior art references to provide the missing limitation as argued

30


replete with other references that teach suturing directly through a valve leaflet as

an artificial chordae tendineae. In open surgical approaches, inserting a suture

directly into one or more leaflets is the preferred approach to preventing leaflet

prolapse as compared with attached a clip to connect leaflets because a suture more

closely mimics the structure and function of the native chordae due to the

flexibility of a suture enabling it to conform to the tissue of the leaflet and allowing

the leaflet to move in a more natural manner. Ex. IOII, ~54. It would be apparent

to one skilled in the art that employing a catheter-based device such as utilized in

Lattoufl to deploy a strand [suture] into a leaflet as an artificial chordae with one

or more leaflets is a minimally invasive technique that more closely mimics the

preferred repair approach employed in open access procedures. Ex.l 0 II, ~67.

1. Obviousness over Lattouf I in view of Carpentier

Cardiac valve surgery - the "French Correction" by Alain Carpentier,

M.D., The Journal of Thoracic and Cardiovascular Surgery, Vol. 86, No. 3,

September 1983 ("Carpentier") was not cited to the Patent Office during

prosecution of the '386 Patent. Carpentier, published in I983 and is prior art to the

'386 Patent under pre-AlA 35 U.S.C. §102(b). This reference is considered a

Patent Owner's during prosecution of the '386 Patent. In Section E, infra,

Petitioner separately argues that the Lattouf family anticipates this limitation.

3I

Petition for InterPartes Review of U.S. Patent 7,635,386

landmark paper on heart valve repair and is widely known to cardiac surgeons.

Ex.l 011, '1[65.

Carpentier discusses a number of methods used to correct mitral and

tricuspid valve functioning during an open surgical approach. One of the methods

discussed for repairing a prolapsed mitral valve leaflet is to insert a suture directly

into a leaflet to suture the leaflet to a secondary chordae. Ex.1009, p.328. Another

discussed method involves resecting a portion of a leaflet and insertion of a suture

directly into the leaflet. !d., pp.327-328. Therefore, even if one were to accept the

unsupported and directly contradicted contention made by Patent Owner that

Lattouf I does not teach a suture directly through a valve leaflet as an artificial

chordae, Carpentier demonstrates this type of repair was well known in the art for

more than 20 years prior to the date of invention of the '386 Patent. Ex.1 011, '1[66.

Although Carpentier is directed to an open surgical approach, one skilled in

the art would have recognized that the minimally invasive beating heart approach

of Lattouf I could be utilized to insert a strand [suture] with the leaflet as taught in

Carpentier as such a modification would simply be a predictable and, in fact,

preferable variation of the technique in Lattouf I of attaching a strand [suture] to a

clip on a leaflet that was the focus of the Patent Owner's argument during

prosecution. Substituting a strand [suture] directly with the leaflet would be a

design change requiring no more than routine skill in the art and doing so would

32


more closely mimic the preferred repair approach used in an open access surgical

procedure. Ex.1011, ~67.

1[A]. A method for Lattoufl discloses that ""one aspect of the invention is repairing a defective directed to ... repairing damaged or otherwise mitral or tricuspid valve, incompetent heart valves." (2:10-14.) com_prising: [B] creating an access in Lattoufl discloses that "[p]referably, the passageway is an apical region of a formed through a region of the heart wall at or near the heart through which a apex of the patient's heart." (2:46-48; see also 7:63-defective cardiac valve is 8:5.) accessed; introducing a device through said access; and [C] repairing said cardiac Lattoufl discloses that "[w]hen there is cordae valve by use of said tendenae damage with the heart valve, particularly device, wherein the when there is severance of the cordae tendenae from repairing comprises the valve leaflet or the papillary muscle, repair of the replacing one or more valve leaflet, even by means of the Bow-Tie technique, chordae tendineae, and may not prevent reshaping of the ventricular using said device to architecture, which can reduce ventricular output. In implant one or more that instance, it has been found that providing an artificial chordae artificial cordae tendenae such as a strand extending tendineae, between the valve leaflets and the heart wall in

generally the same orientation as the cordae tendenae will support the connected valve leaflets in more or less a normal manner to minimize ventricular deformation (e.g. dilation) which leads to decreased output." (3:46-58; see also 3:24-35.)

[D] and wherein the one Carpentier discloses that "[t]he free edge of the or more artificial chordae prolapsed leaflet is sutured to adjacent secondary comprises a suture with chordae. This technique requires on or two thick and one or more leaflets of strong secondary chordae close to the prolapsed part of the heart. the leaflet. Two or three sutures are passed through the

chordae then through the leaflet at a corresponding level." (p.328.) See also Lattoufl 3:58-62.

19[A]. A method for Lattoufl discloses that ""one aspect of the invention is treating a defective directed to ... repairing damaged or otherwise

33


mitral or tricuspid valve, incompetent heart valves." (2: I 0-14 and 7:63-8:5.) compnsmg: [B] percutaneously Lattoufl discloses that "[p]referably, the passageway is accessing an apical formed through a region of the heart wall at or near the region of a heart with a apex of the patient's heart." (2:46--48.) catheter-based device; and [C) repairing a cardiac Lattoufl discloses that "[w]hen there is cordae valve by use of said tendenae damage with the heart valve, particularly device, wherein the when there is severance of the cordae tendenae from

• • 0

the valve leaflet or the papillary muscle, repair of the repamng compnses replacing at least one valve leaflet, even by means ofthe Bow-Tie technique, chordae tendineae, and may not prevent reshaping of the ventricular

architecture, which can reduce ventricular output. In that instance, it has been found that providing an artificial cordae tendenae such as a strand extending between the valve leaflets and the heart wall in generally the same orientation as the cordae tendenae will support the connected valve leaflets in more or less a normal manner to minimize ventricular deformation (e.g. dilation) which leads to decreased output." (3 :24-28 and 46-58.)

[D]wherein the replaced Carpentier discloses that "[t]he free edge of the chordae tendineae prolapsed leaflet is sutured to adjacent secondary comprises a suture with chordae. This technique requires on or two thick and one or more leaflets of strong secondary chordae close to the prolapsed part of the heart. the leaflet. Two or three sutures are passed through the

chordae then through the. leaflet at a corresponding level." (p.328.) See also Lattoufl 3:58-62.

In addition, at least dependent claims 3, 6-9, 11-15, 17-18 and 22-23 are also

obvious over the combination of Lattoufl in view of Carpentier as set forth for the

corresponding independent claim in light of the further teachings of Lattouf I that

describe the additional claim limitations in these dependent claims. Ex.1 011, ~68.

34


3. The method of claim Lattoufl discloses that"[ s ]uitable leaflet connecting 1, wherein the device is a elements include clips, staples, and the like." (3:15-16.) suturing or stapling device. 6. The method of claim Lattoufl discloses that "[t]he jaws ofthe grasping 1, wherein the repairing device are opened to engage the stabilized valve leaflets comprises performing a in the grasping location and then closed to grip the bow-tie Alfieri leaflets so that the free edges of the valve leaflets are procedure. placed into an operative position for the Bow-Tie

repair." (3 :31-35.) 7. The method of claim Lattoufl discloses that "[i]nstruments for such 1, wherein the repair is procedures must be long enough, have small enough performed while the profile and have sufficient flexibility for advancement heart is beating. through the patient's vasculature into the patient's heart

chamber. However, they must also be able to accurately locate the operative ends of such instruments at a desired location within the chambers of the patient's beating heart and be strong enough to perform the required functions." (1 :60-67.)

8. The method of claim Lattoufl discloses that "[t]his invention generally 1, wherein the method is relates to minimally invasive therapeutic procedures, a minimally invasive including valve repair." (2:11. 7-8.) procedure. 9. The method of claim Lattoufl discloses that "[a]s shown in FIG. 28, the 1, wherein the method pacing lead 60 can be deployed within the patient's comprises the use of chest cavity by minimally invasive techniques through endoscopy. a trocar 61 located in the intercostal space between the

patient's ribs. The placement of the pacing lead 60 can be observed by an endoscopic video 62 extending through an intercostal space." (8"64- 9:2.)

11. The method of claim Lattoufl discloses that "[o]ne end of the strand is 1, wherein said repairing secured to the connecting element securing the free comprises: anchoring the edges of the valve leaflets or to the free edges one or more artificial themselves and the other end of the strand is secured to chordae to a tissue in the a location on the heart wall, preferably on the exterior apical region of the of the heart wall. The strand should be relatively heart. inelastic or non-compliant to ensure an effective closed

position of the leaflets. In this case it is preferred that the passageway through the ventricular wall pass

35


through the apex region of the heart between the two papillary muscles in the left ventricle, so that the pull on the valve leaflets by the strand secured to the leaflets is in approximately the same angle or orientation as the natural pull by the competent cordae tendenae" (3:58-4:3.)

12. The method of claim Lattouf I discloses that "the strand is secured to a 11, wherein the apical location on the heart wall." (3:60-62.) tissue is internal to the heart. 13. The method of claim Lattoufl discloses that "the strand is secured to a 11, wherein the apical location on the heart wall." (3:60-62.) tissue is a papillary muscle, a papillary connective tissue or an endocardial tissue in the lower ventricle. 14. The method of claim Lattoufl discloses that "the strand is secured to a 11, wherein the apical location on the heart wall." (3:60-62) tissue is the epicardium. 15. The method of claim Lattoufl discloses that "the proximal end 58 of the 11 , further comprising strand 56 is pulled taut to position the leaflets 14 and 15 determining an optimal in a natural position to ensure proper closure during configuration of the one systole and then the proximal end 58 of the strand 56 is or more artificial chordae secured to the free ventricular wall32." (8:41-45.) before anchoring the artificial chordae. 1 7. The method of claim Lattoufl discloses that "the proximal end 58 of the 15, wherein the artificial strand 56 is pulled taut to position the leaflets 14 and 15 chordae are anchored to in a natural position to ensure proper closure during the apical tissue systole and then the proximal end 58 of the strand 56 is subsequent to said secured to the free ventricular wall32." (8:41-45.) determination. 18. The method of claim Lattoufl discloses "[t]he distal end of tubular member 1, wherein the repairing 71 is provided with a vacuum pod 79 to secure the comprises the application distal end to the exposed surface of the free ventricular of a vacuum. wall32." (9:27-29.) 22. The method of claim Lattoufl discloses that "[p]referably, the passageway is 19, wherein said formed through a region of the heart wall at or near the

36


accessing is done via apex of the patient's heart." (2:46-48.) direct access through a transmyocardial approach. 23. The method of claim Lattoufl discloses that "[ o ]ne end ofthe strand is 19, wherein the replacing secured to the connecting element securing the free comprises anchoring a edges of the valve leaflets or to the free edges neochord to the apical themselves and the other end of the strand is secured to regwn. a location on the heart wall, preferably on the exterior

of the heart wall. The strand should be relatively inelastic or non-compliant to ensure an effective closed position of the leaflets. In this case it is preferred that the passageway through the ventricular wall pass through the apex region of the heart between the two papillary muscles in the left ventricle, so that the pull on the valve leaflets by the strand secured to the leaflets is in approximately the same angle or orientation as the natural pull by the competent cordae tendenae." (3:58-4:3.)

At least dependent claims 2 and 4-5 of the '386 Patent are also obvious over

the combination of Lattouf I in view of Carpentier as set forth for the

corresponding independent claim in light of the further teachings of Carpentier that

describe the additional claim limitations found in these dependent claims. Claim 2

(leaflet resection), claim 4 (annuloplasty) and claim 5 (annuloplasty effect) recite

alternative and/or complementary valve repair procedures that are discussed in

Carpentier and have been !mown for decades prior to the '386 Patent as being

among a finite number of available valve repair procedures. Ex.l009, pp.327-328

and 333. It would be obvious to one skilled in the art to utilize any of these !mown

procedures with the device of Lattouf when the use of such additional and

37


complimentary procedures would be seen as desirable and routine m the

professional judgment of the cardiac surgeon. Ex.l 011, ~69.

2. The method of claim Carpentier discloses that "[p]rolapse of the mural 1, wherein the repairing leaflet, whether the result of ruptured chordae or comprises resecting one elongated chorae, is treated by extensive rectangualr or more leaflets. resection of the prolpased portion, annular plication in

the corrsponding area, and subsequent sutrue of the free edges fo the leaflets (Fig. 9). (pp.327-328.)

4. The method of claim Carpentier discloses that "[p ]rosthetic ring annuloplasty I, wherein the repairing is one of the major steps of valve reconstruction." comprises annuloplasty. (p.327.) 5. The method of claim Carpentier discloses that "Dilation and deformation of 1, wherein the repairing the tricuspid annulus can approriately be corrected by comprises stapling or suitably shaped and dized proshtetic rings. This suturing the annulus to technique has the follwing advantages over the create an annuloplasty semicircular suture or the annular plication techniques." "effect". (p.333.)

2. Obviousness over Lattouf I in view of Carpentier and Downing

Dependent claims 10, 16, 20 and 21 are obvious over the combination of

Lattouf I in view of Carpentier as described with respect to the corresponding

independent claim, and further in view of U.S. Patent No. 6,840,246 (Downing).

Downing was before the Examiner as a secondary reference in rejecting certain

dependent claims of the '386 Patent and is prior art to the '386 Patent under 35

U.S.C. § 102(b). Ex.1003, pp24-25. Each of these dependent claims relate to

various visualization methods such as sonography (claim 1 0) and sonic guidance

(claim 16) or endovascular access approaches (claims 20-21) that are disclosed in

Downing and were known in the art as of the '386 Patent for beating heart and/or

38


minimally invasive procedures. Ex.I 0 II, ~71. It would have been obvious to one

skilled in the art to modify the procedure of Lattouf I to utilize these known

visualization techniques or known alternative access approaches taught by

Downing to more closely mimic an open access procedure. Ex.I003, pp.24-25;

Ex.10I1, ~71.

10. The method of claim Downing discloses that "[t]he present invention 1, wherein the contemplates repairing a beating heart using introduction of the echocardiography or real-time CT scanning or magnetic device is performed in resonance imaging (MRI) to 'see' through the blood." conjunction with (11:34-38.) sonography or direct transblood visualization. 16. The method of claim Downing discloses that "[a] trans-esophageal echo 15, wherein the (TEE) probe, such as the OMINIPLANE device determining comprises marketed by Hewlett-Packard, will be advanced into the use of sonic position and connected to a monitor, such as the guidance. SON OS 1000 marketed Hewlett-Packard. The left

atrium will then be imaged (imaging planes chosen as described below). Under TEE guidance, the free edge of the posterior leaflet will be grasped, if needed, with an endoscopic grasper, such as a Genzyme Snowden-Pencer." (18:40-53.)

20. The method of claim Downing discloses "the apparatuses and methods are 19, wherein said compatible with several types of diagnostic and accessing is done surgical techniques, including mitral valve repair, endovascularly via an repair of atrial or ventricular septal defects, antegrade approach. endovascular aortic surgery, and electrophysiologic

studies." (3:38-42.) 21. The method of claim Downing discloses "the apparatuses and methods are 19, wherein said compatible with several types of diagnostic and accessing is done surgical techniques, including mitral valve repair, endovascularly via a repair of atrial or ventricular septal defects, retrograde approach. endovascular aortic surgery, and electrophysiologic

studies." (3:38-42.)

39


3. Obviousness over Lattouf I in view of Bachman

Bachman, discussed in Section VI(B)(3), teaches a minimally invasive

mitral valve repair device that is utilized to grasp a valve leaflet and insert a suture

through the leaflet9. Ex.l008, Figs. 10-11 and [0042]-[0043]; Ex.l 011, ~72.

48

Portion of Figure 10 of Bachman showing suture 62 through tissue 74 such as a leaflet

Bachman expressly teaches the element of the claims of the '386 Patent

argued by the Patent Owner during the prosecution history as missing from the

prior art. As set forth above, it would have been obvious to one skilled in the art to

use the method of Lattouf I to insert the suture through the valve leaflet as taught

in Bachman as doing so would require no more than routine skill in the art and

9 Bachman is not redundant of Carpentier because it teaches a minimally

invasive procedure, whereas Carpentier discusses an open surgical approach.

40


would provide a better result that more closely mimics what a surgeon would do in

an open surgical approach based on well-known knowledge of the desirability of

using a suture over a clip. Ex. lOll,~ 73. At least claims 1, 3-9, 11-15, and 17-23 10

of the '3 86 Patent are obvious over Lattouf I in view of Bachman. Ex.l 008, [0006]

(claims 4-5), [0009] (claim 6), [0042] (claim 18) and [0046] (claims 20-21 );

Ex. lOll, ~74.

1. A method for See citations to elements lA-lC in Lattoufi on pages repairing a defective 27-29, which are incorporated by reference herein mitral or tricuspid valve, comprising ...

[D]and wherein the one Bachman discloses that "[o]nce the tissue (leaflet) is or more artificial sufficiently stabilized, the fastener deployment actuator chordae comprises a 24 located on the handle 12 may be actuated to deploy a suture with one or more fastening device (suture) through the tissue portion 72." leaflets of the heart. (Para. [0042].)

4. The method of claim Bachman discloses that "[v]alvular remodeling is 1, wherein the repairing accomplished by implanting a prosthetic ring comprises annuloplasty. ("annuloplasty ring") into the valve annulus to reduce

and/or stabilize the structure of the annulus. Annuloplasty rings are typically constructed of a resilient core covered with a fabric sewing material. Annuloplasty procedures can be performed alone, or

10To avoid redundancy, this and subsequent claim charts only cite material that

has not previously been cited in an earlier claim chart. For example, this claim

chart does not cite to Lattoufi for the teachings relevant to claims 1, 3, 7-9, 11-15,

17, 19 and 22-23 because those teachings have already been presented in the claim

charts in Section VI(C)(l).

41


they can be performed in conjunction with other procedures such as leaflet repair." (Para. [0006].)

5. The method of claim Bachman discloses that "[v]alvular remodeling is 1, wherein the repairing accomplished by implanting a prosthetic ring comprises stapling or ("annuloplasty ring") into the valve annulus to reduce suturing the annulus to and/or stabilize the structure of the annulus. create an annuloplasty Annuloplasty rings are typically constructed of a "effect". resilient core covered with a fabric sewing material.

Annuloplasty procedures can be performed alone, or they can be performed in conjunction with other procedures such as leaflet repair." (Para. [0006].)

6. The method of claim Bachman discloses that "[t]he bow-tie technique has 1, wherein the repairing proved to be a viable alternative for treating otherwise comprises performing a incompetent heart valves" and depicts the technique bow-tie Alfieri as performed by the disclosed repair device. (Para. procedure. [0009] and FIGS 12-13.) 18. The method of claim Bachman discloses a device with a vacuum port used 1, wherein the repairing such that "the tissue portion 72 located proximate the comprises the vacuum port 52 is grasped and retained by the application of a vacuum. vacuum force" so that a suture can be inserted

through the tissue portion (leaflet). (Para. [0042].) 19. A method for See citations to elements 19A-19C in Lattoufl on treating a defective pages 27-29, which are incorporated by reference mitral or tricuspid valve, herein compnsmg ...

[D]wherein the replaced Bachman discloses that "[o]nce the tissue (leaflet) is chordae tendineae sufficiently stabilized, the fastener deployment actuator comprises a suture with 24 located on the handle 12 may be actuated to deploy a one or more leaflets of fastening device (suture) through the tissue portion 72." the heart. (Para. [0042].)

42


20. The method of claim 19, wherein said accessing is done endovascularly via an antegrade approach.

and

21. The method of claim 19, wherein said accessing is done endovascularly via a retrograde approach.

Bachman discloses "[t]hose skilled in the art will appreciate that the mitral valve repair device 10 of the present invention may approach the cusp of the mitral valve from an antegrade position or from a retrograde position as desired by the user. For a retrograde approach, the user attaches the repair device 10 to the guidewire emerging from the left femoral artery. The device is then advanced along the guidewire to a position proximate the retrograde aspect of the mitral valve. The engagement tip 16 of the mitral valve repair device 10 may be positioned proximate the tissue portion 72 of the mitral valve. Once suitably positioned, the tip actuator 22 positioned on the handle 12 may be actuated, thereby resulting in the extendable tip 48 of the engagement tip 16 extending distally from the fastener deployment housing 46." (Para. [0046].)

To the extent that dependent claims 2, 10, and 16 may not be obvious over

Lattouf I and Bachman, these claims are obvious further in view of the Downing

reference, because a modification of the procedure to accomplish the claimed steps

described in Downing would be obvious when, in the professional judgment of one

skilled in the art, such known limitations would enhance the treatment of the

patient, as discussed in sections VI(C)(2) and VI(C)(4). Ex.1011, ~74

4. Obviousness over Lattouf I in view of Downing

Although Downing was before the Examiner as a secondary reference, 11 it

11 This ground asserts Downing as a secondary reference similar to the

rejections made during prosecution, but is not redundant of the other grounds in

43


was apparently never reviewed on the record by the Examiner as to any teaching of

directly suturing a leaflet. Ex.l003, pp.24-25. As with Lattoufl, the arguments set

forth by the Patent Owner that Downing does not include such a teaching are

expressly contradicted by the reference itself.

Downing includes more than 40 figures and 22 columns of text discussing

numerous embodiments. Ex.1008, 7:28-38. In discussing Downing during

prosecution, Patent Owner focused only on the claimed embodiment highlighted in

the Abstract directed to a "method of repairing a mitral valve [that] uses staples

which may be banded together with a strip of material." Ex.1003, pp.16-17. This

claimed embodiment, however, is discussed at only a small portion of the Downing

specification. Ex.1008, 15:13-16:9. The other described but unclaimed

embodiments in the specification were apparently overlooked by the Examiner

because Downing expressly contradicts the statement made by Patent Owner that

the limitation "wherein the one or more artificial chordae comprises a suture with

one or more leaflets of the heart" is not taught by Downing. Downing expressly

states that "[t]he cardiac port is designed to enable several standard surgical

techniques to be performed as minimally invasive surgeries, including bow-tie

repair, chordal replacement, and annuloplasty ring replacement. Jd., 12:4-7

this Petition as this ground is presented to demonstrate that a mistake was made

during the original prosecution of the '386 Patent.

44


(emphasis added). Specifically with regard to chordal replacement, Downing states

that: "The free ends of the suture can then be brought through the edge of the

operative mitral valve leaflet." I d., 15:2-12 (emphasis added); see also 14:12-15

Downing therefore clearly and unequivocally discloses the very teaching

identified by the Patent Owner as missing from both Lattouf I and Downing -

inserting a suture directly through a leaflet. Ex.lOll, ~75. The Examiner during

prosecution of the '386 Patent has already set forth a reasoned rationale for

modifYing Lattouf I to include various procedures that are disclosed as being

capable of being performed with the system of Downing, including leaflet

resection and annuloplasty, for example, "because the methods are well known ...

and could be performed on the beating heart operation as disclosed by Lattouf."

Ex.l003, pp. 24-25. In fact, the operation described by Downing of inserting a

suture directly into a leaflet would be a preferable procedure to the embodiment of

the procedure described in Lattouf I that was discussed in Patent Owner's

Amendment of first attaching a clip to one or more leaflets and then attaching a

strand [suture] to the clip. It would therefore further have been obvious to utilize

the teachings of Downing as a substitution for the clip that would require no more

than routine skill in the art as this combination would provide a better and

predictable result that would mimic what a surgeon would do in an open surgical

approach based on well-known knowledge of the desirability of using a suture over

45


a clip. Ex.1011, ~76.

Each of claims 1-23 of the '386 Patent is obvious over the combination of

Lattouf and Downing, as Downing further discloses the limitations of at least

dependent claims 2, 4-5, 10, 16 and 20-21 in addition to expressly disclosing use of

a suture directly with a leaflet as an artificial chordae and the reasons to combine

the references are the same as given above with respect to claims 1 and 19.

Ex.1005; Ex.1011, ~77.

1. A method for See citations to elements 1A-1C in Lattoufl on page repairing a defective 27-29 which are incorporated by reference herein. mitral or tricuspid valve, compnsmg ... Downing discloses that [i]f resecurement of one of the

chordae to the papillary muscle PM of the ventricle is [D]and wherein the one needed, a curved suture placement device 61 can be or more artificial chordae inserted through the lumen of port 50 and placed across comprises a suture with the mitral valve MV, as shown in FIG. 17. The suture one or more leaflets of placement device 61 then can be fired into the papillary the heart. muscle PM. The free ends of the suture then can be

brought through the edge of the operative mitral leaflet (here, in FIG. 17, the anterior mitral leaflet, although, in reality, it is usually the posterior mitral leaflet having the tom chord), as described above in connection with FIGS. 10-14." (15:2-12.)

2. The method of claim Downing discloses that "standard mitral valve 1, wherein the repairing repair techniques involved resecting areas of comprises resecting one redundant valve leaflets and mechanically reducing or more leaflets. the valve annulus, thus improving leaflet edge

coaptation to restore valve competence." (11 :60-63.)

4. The method of claim Downing discloses that "the cardiac port is designed to 1 , wherein the repairing enable several standard surgical techniques to be comprises annuloplasty. performed as minimally invasive surgeries, including

bow-tie repair, chordal replacement, and annuloplasty

46


ring placement." (12:4-7.) 5. The method of claim Downing discloses that "if a reduction in the posterior 1, wherein the repairing mitral annulus is needed to supplement the repair, a comprises stapling or stapled annuloplasty can be performed." (15:13-15.) suturing the annulus to create an annuloplasty "effect". 19. A method for See citations to Lattoufl on pages 27-29 treating a defective mitral or tricuspid valve, comprising ... Downing discloses that [i]fresecurement of one of the

chordae to the papillary muscle PM of the ventricle is [D]wherein the replaced needed, a curved suture placement device 61 can be chordae tendineae inserted through the lumen of port 50 and placed across comprises a suture with the mitral valve MV, as shown in FIG. 17. The suture one or more leaflets of placement device 61 then can be fired into the papillary the heart. muscle PM. The free ends of the suture then can be

brought through the edge of the operative mitral leaflet (here, in FIG. 17, the anterior mitral leaflet, although, in reality, it is usually the posterior mitral leaflet having the tom chord), as described above in connection with FIGS. 10-14." (Col. 1511. 2-12.)

E. U.S. Patent No. 7,871,433 to Lattouf (Lattouf II)

Lattouf II claims priority to a continuation-in-part application of Lattouf I

that was filed December 6, 2002 and is prior art to the '386 Patent under pre-AlA

35 U.S.C. §102(b). Ex.1007. Although the related Lattoufl patent was the primary

reference applied against the claims of the '386 Patent during prosecution, the

record does not reflect that the Examiner ever appreciated the fact that Lattouf I

teaches directly suturing to a leaflet rather than to a clip on the leaflet. Ex.l003,

pp.21-26. In addition, the argument set forth by the Patent Owner during

prosecution - saying that Lattouf I does not include such a teaching - is

47


demonstrably incorrect. Lattouf II, which was issued after the '386 Patent issued,

specifically claims securing an artificial chordate tendineae directly between the

heart wall to a free edge of a valve leaflet. 12 Ex.1 007, 13:60-62.

1. Claims 1, 3, 5-9, 11-15, 17-19 and 22-23 are anticipated by Lattoufll

To obtain allowance of the claims of the '386 Patent over Lattouf I during

prosecution, Patent Owner specifically argued that "Lattouf does not disclose or

suggest that the strand includes a suture in the leaflets." Ex. 1003, p. 14. The

Lattouf patent family, however, is not so limited as the Patent Owner led the

Examiner to believe. Lattouf II, a patent in the Lattouf patent family issued after

the prosecution of the '386 Patent was completed, expressly claims securing the

opposite ends of an artificial chordate tendineae [strand] between a free edge of a

valve leaflet and the wall of the heart.

1. A method for treating a valve of a patient's heart, the valve having a

valve leaflet, comprising:

a. providing an artificial chordate tendineae having first and second

portions;

12 Lattoufll as presented in this ground is not redundant of the other grounds in

this Petition as Lattouf II is separately argued as an anticipatory reference in light

of the issued claims for a patent that was not before the Examiner during

prosecution of the '386 Patent.

48


b. advancing the artificial chordae tendineae through a passageway in

a wall of the patient's heart into a heart chamber defined in part by the

wall;

c. securing the first portion of the artificial chordae tendineae to a

free edge of the valve leaflet from within the patient's heart; and

d. securing the second portion of the artificial chordae tendenae to

the wall which defines in part the heart chamber.

26. The method of claim 1 wherein the first and second portions of

the artificial chordae tendineae are ends.

Ex.1007, 13:51-65 and 16:3-4. (emphasis added). See also Ex.1007,

4:5-15.

Lattoufll not only discloses, it expressly claims securing a strand [suture ]as

an artificial chordae directly between a free edge of a valve leaflet to the heart wall

through minimally invasive apical access. The limitation was allowed by the Patent

Office and is therefore presumed to have support in the disclosure of Lattouf II

consistent with the presumption of validity of the issued claims. As such, the

contention by Patent Owner during prosecution, and evidently accepted by the

Examiner, that Lattouf I fails to disclose "wherein the one or more artificial

chordae comprises a suture with one or more leaflets of the heart" is expressly

contradicted by the additional claims found in the subsequent Lattouf family

patents. Ex.l 011, ~79. The remaining limitations of the independent claims are

49


anticipated by Lattouf II as set forth in the Office Action and implicitly admitted

by Patent Owner. Ex.1011, ~80.

1 [A]. A method for repairing a Lattouf II discloses "[a] method for treating a defective mitral or tricuspid valve of a patient's heart." (12:52-53; see also valve, comprising: 2:15-20.)

[B]creating an access in an Lattouf II discloses "wherein the first portion of apical region of a heart through the artificial chordate tendineae is passed through which a defective cardiac valve a passageway in an apical region of the patient's is accessed; introducing a heart." (16:7-9; see also 2:50-52 and 8:65-9:8.) device through said access; and [C]repairing said cardiac valve Lattouf II discloses "providing an artificial by use of said device, wherein chordate tendineae." (13:55-56; see also 3:1. 66-the repairing comprises 4:12 and 3:45-55.) replacing one or more chordae tendineae, and using said device to implant one or more artificial chordae tendineae, [D]and wherein the one or Lattoufii discloses "securing the first portion of more artificial chordae the artificial chordae tendineae to a free edge of comprises a suture with one or the valve leaflet" and "securing the second more leaflets of the heart. portion of the artificial chordae tendenae to the

wall which defines in part the heart chamber." Lattouf II also discloses "wherein the first and second portions of the artificial chordae tendineae are ends." (13:60-62 and 16:2-4; see also 4:5-15.)

19[A]. A method for treating a Lattoufii discloses that ""one aspect of the defective mitral or tricuspid invention is directed to ... repairing damaged or valve, comprising: otherwise incompetent heart valves." (2:15-20.) [B]percutaneously accessing an Lattoufii discloses that "[p]referably, the apical region of a heart with a passageway is formedthrough a region of the catheter-based device; and heart wall at or near the apex of the patient's

heart." (2:50-52; see also 8:65-9:8.) [C]repairing a cardiac valve by Lattoufii discloses that "[w]hen there is cordae use of said device, wherein the tendenae damage with the heart valve, repairing comprises replacing particularly when there is severance of the cordae at least one chordae tendineae, tendenae from the valve leaflet or the papillary

50


and muscle, repair of the valve leaflet, even by means of the Bow-Tie technique, may not prevent reshaping of the ventricular architecture, which can reduce ventricular output. In that instance, it has been found that providing an artificial cordae tendenae such as a strand with one end secured to the secured valve Ieafletes and another end secured to the heart wall, particularly in the same orientation as the cordae tendenae, will support the connected valve leaflets in more or less a normal manner to minimize ventricular deformation (e.g. dilated cardiomyopathy) which leads to decreased output." (3 :66- 4: 12; see also 3:45-55.)

[D]wherein the replaced Lattoufll discloses that "[o]ne end of the strand chordae tendineae comprises a is secured to the connecting element securing the suture with one or more leaflets free edges of the valve leaflets or to the free of the heart. edges themselves and the other end of the strand

is secured to a location on the heart wall." (4:5-15.)

As discussed above with respect to Lattouf I, for the same reasons, at least

the limitations of dependent claims 3, 6-9, 11-15, 17-18 and 22-23 are anticipated

by the primary Lattouf II reference. Ex.1007, 2:1-5 (claim 7), 2:12-13 (claim 8),

3:22-24 (claim 3), 3: 51-55 and 14:30-32 (claim 6), 4:12-27 and 14:9-15 (claims

11-14 and 23), 9:53-57 (claims 15 and 17), 10:9-15 (claim 9) and 10:38-44 (claim

18). Ex.1011, ~81.

2. Remaining dependent claims are obvious over Lattouf II in view of Downing

To the extent that dependent claims 2, 4-5, 10, 16, 20 and 21 may not be

anticipated by Lattouf II, these claims are obvious over Lattouf in view of

51


Downing. As discussed above in sections VI(C)(2) and VI(C)(4), the limitations of

each of these claims are taught by Downing and therefore the claims are obvious

over the combination of Lattouf II and Downing, as set forth during prosecution of

the '386 Patent, "because the methods are well known ... and could be performed

on the beating heart operation as disclosed by Lattouf." Ex.l003, p.24-25;

Ex. lOll, ~81.

F. U.S. Patent No. 6,840,246 to Downing

Downing was before the Examiner during prosecution of the '386 Patent as

a secondary reference, but only as a secondary reference. Downing was never

reviewed on the record as to a teaching of the allegedly patentable limitation of

"wherein the one or more artificial chordae comprises a suture with one or more

leaflets of the heart." Ex.l003, pp.24-25. As discussed above, Downing not only

teaches this limitation, but teaches a substantially similar overall procedure to that

claimed in the '3 86 Patent. 13

13 Downing as presented in this ground is not redundant of the other grounds in

this Petition as Downing is separately argued as primary reference for obviousness

in view of a completely different secondary reference (Oz) that was not before the

Examiner during prosecution.

52


1. Obviousness over Downing in view of U.S. Patent No. 6,269,819 to Oz

Downing teaches accessing a defective cardiac valve of a beating heart with

a device that replaces one or more natural chordae tendineae with one or more

artificial chordae tendineae that are sutured through the valve leaflet. Ex.1 005,

15 :2-12; Ex.l 011, ~83. Downing primarily describes a technique that utilizes an

open surgical access approach, but notes that the procedure would be adaptable to

minimally invasive surgery "in the future with yet-to-be-developed suture

placement devices." !d., 12:16-34.

The expressly described technique of Downing differs from the claims of the

'386 Patent in that while Downing describes "[a] chamber port for insertion

through a chamber wall of a heart chamber to perform a medical procedure inside

of a beating heart," Downing describes the access point for entrance into the heart

chamber as being "positioned through the wall of the left atrium" rather than an

apical region of the heart14• Ex.l005, 3:43-45 and 7:43-46. However, Downing

14 Downing expressly teaches implanting a suture directly into a leaflet, but

from an access approach that enters the heart at the left atrium. The basis for

obviousness for Downing (obvious to apply the expressly taught technique of a

suture with a leaflet from a different surgical access approach) is therefore

53


specifically notes that access "through the apex of the left ventricle of the heart" to

access valve leaflets is known in the art. Id., 3:14-19 (citing the work of Dr.

Mehmet Oz); Ex.1 011, '1[85.

FIG.17

Fig. 17 of Downing showing atrial access for valve repair (left) and Fig. 3 of Oz showing apical access for valve repair (right)

To the extent Downing notes that access through the atrium is "preferred,"

the reasoning behind the preference is in part to enable access to the valve annulus

(located "above" the leaflets), which is not a concern in chordal replacement and

therefore unnecessary to properly effectuate the chordal replacement procedure of

Downing. See id., 7:44-47. It would therefore involve no more than routine skill in

the art to modifY the chordal replacement procedure of Downing to utilize the

known technique of accessing the valve through the apical region of the heart as

different from those discussed above (desirability of replacing a clip with a

suture).

54


discussed in Downing and as expressly taught in U.S. Patent No. 6,269,819 to the

same Dr. Oz (Oz) discussed in Downing. Ex.1005, 8:1-11; Ex. 1010; Ex.1011,

~86. Independent claims 1 and 19 are therefore obvious over Downing in view of

Oz.

1 [A]. A method for Downing discloses "the apparatuses and methods are repairing a defective compatible with several types of diagnostic and mitral or tricuspid valve, surgical techniques, including mitral valve repair." comprising: (3:38--41.) [B]creating an access in Oz teaches that "such a procedure can be undertaken an apical region of a thorascopically. The patient is intubated selectively in heart through which a order to collapse the left lung, and percutaneous ports defective cardiac valve is are inserted in to the left chest allowing visualization of accessed; introducing a the apex of the heart or left atrium. Through a separate device through said port, the device is introduced into the thoracic cavity access; and and subsequently into the left ventricle through the

apex." (8:1-7; see also 7:39-46.) [C]repairing said cardiac Downing discloses that "FIG. 17 schematically valve by use of said illustrates a curved suture placement device inserted device, wherein the through a cardiac port to replace a chordae of the mitral . . .

valve." (6:45--47.) repamng compnses replacing one or more chordae tendineae, and using said device to implant one or more artificial chordae tendineae, [D]and wherein the one Downing discloses that [i]f resecurement of one of the or more artificial chordae chordae to the papillary muscle PM of the ventricle is comprises a suture with needed, a curved suture placement device 61 can be one or more leaflets of inserted through the lumen of port 50 and placed across the heart. the mitral valve MV, as shown in FIG. 17. The suture

placement device 61 then can be fired into the papillary muscle PM. The free ends of the suture then can be brought through the edge of the operative mitral leaflet (here, in FIG. 17, the anterior mitral leaflet, although, in reality, it is usually the posterior mitral leaflet having

55


19[A]. A method for treating a defective mitral or tricuspid valve, comprising: [B )percutaneously accessing an apical region of a heart with a catheter-based device; and

[C]repairing a cardiac valve by use of said device, wherein the repairing comprises replacing at least one chordae tendineae, and [D]wherein the replaced chordae tendineae comprises a suture with one or more leaflets of the heart.

the torn chord), as described above in connection with FIGS. 10-14." (15:2-12.)

Downing discloses "the apparatuses and methods are compatible with several types of diagnostic and surgical techniques, including mitral valve repair." (3 :3 8--41.) Oz teaches that "such a procedure can be undertaken thorascopically. The patient is intubated selectively in order to collapse the left lung, and percutaneous ports are inserted in to the left chest allowing visualization of the apex of the heart or left atrium. Through a separate port, the device is introduced into the thoracic cavity and subsequently into the left ventricle through the apex." (8:1-7; see also 7:39-46.) Downing discloses that "FIG. 17 schematically illustrates a curved suture placement device inserted through a cardiac port to replace a chordea of the mitral valve." (6:45-47.)

Downing discloses that [i]fresecurement of one of the chordae to the papillary muscle PM of the ventricle is needed, a curved suture placement device 61 can be inserted through the lumen of port 50 and placed across the mitral valve MY, as shown in FIG. 17. The suture placement device 61 then can be fired into the papillary muscle PM. The free ends of the suture then can be brought through the edge of the operative mitral leaflet (here, in FIG. 17, the anterior mitral leaflet, although, in reality, it is usually the posterior mitral leaflet having the torn chord), as described above in connection with FIGS. 10-14." (15:2-12.)

At least the limitations of dependent claims 2-13, 16 and 20-23 of the '386

Patent are taught by Downing and would therefore further be obvious over

Downing in view of Oz because the limitations are expressly taught by Oz and one

56


skilled in the art would use professional judgment to determine whether such

limitations would enhance the treatment of a particular patient. Ex. lOll, ~87.

2. The method of claim Downing discloses that "standard mitral valve repair 1, wherein the repairing techniques involved resecting areas of redundant comprises resecting one valve leaflets and mechanically reducing the valve or more leaflets. annulus, thus improving leaflet edge coaptation to

restore valve competence." ( 11 :60-63.) 3. The method of claim Downing discloses that "if resecurement of one of the 1, wherein the device is chordae to the papillary muscle PM of the ventricle is a suturing or stapling needed, a curved suture placement device 61 can be device. inserted through the lumen of port 50 and placed

across the mitral valve MV, as shown in FIG. 17. The suture placement device 61 then can be fired into the papillary muscle PM. The free ends of the suture then can be brought through the edge of the operative mitral leaflet (here, in FIG. 17, the anterior mitral leaflet, although, in reality, it is usually the posterior mitral leaflet having the tom chord), as described above in connection with FIGS. 10-14." (15:2-12.)

4. The method of claim Downing discloses that "the cardiac port is designed 1, wherein the repairing to enable several standard surgical techniques to be comprises annuloplasty. performed as minimally invasive surgeries, including

bow-tie repair, chordal replacement, and annuloplasty ring placement." (12:4-7.)

5. The method of claim Downing discloses that "if a reduction in the posterior 1, wherein the repairing mitral annulus is needed to supplement the repair, a comprises stapling or stapled annuloplasty can be performed." (15:13-15.) suturing the annulus to create an annuloplasty Oz discloses that "[a] posterior suture annuloplasty "effect". (De Vega) served as control." (8:41-42.)

6. The method of claim Downing discloses that '"'[t]he Alfiori method 1, wherein the repairing involves fixing the redundant section of a leaflet to comprises performing a the opposite valve edge. This recently described bow-tie Alfieri technique has been demonstrated to be effective and procedure. is technically simple enough to apply to the beating

heart. The cardiac port of the present invention improves upon the Alfiori method by providing

57


access to the mitral valve without the use ofCPB." (11:63- 12:3.)

7. The method of claim Downing discloses that "[t]he present invention 1, wherein the repair is relates generally to an apparatuses and methods for performed while the performing minimally invasive diagnostic and heart is beating. surgical procedures inside of a beating heart." (1 :12-

14.) 8. The method of claim Downign discloses that "[t]he present invention 1, wherein the method is relates generally to an apparatuses and methods for a minimally invasive performing minimally invasive diagnostic and procedure. surgical procedures inside of a beating heart." (1: 12-

14.) 9. The method of claim Downing discloses that "[m]itral valve repair, for 1, wherein the method example, can be performed on the beating heart, comprises the use of without the use of CPB, through a combination of endoscopy. next generation imaging techniques, endoscopic

suture placement devices, and simplified valve repair techniques." (11 :39-43.)

1 0. The method of claim Downing discloses that "[t]he present invention 1 , wherein the contemplates repairing a beating heart using introduction ofthe echocardiography or real-time CT scanning or device is performed in magnetic resonance imaging (MRI) to 'see' through conjunction with the blood." (11 :34-38.) sonography or direct transblood visualization. 11. The method of claim Downing discloses that "[t]he suture placement 1, wherein said repairing device 61 then can be fired into the papillary muscle comprises: anchoring the PM. The free ends of the suture then can be brought one or more artificial through the edge of the operative mitral leaflet (here, chordae to a tissue in the in FIG. 17, the anterior mitral leaflet, although, in apical region of the reality, it is usually the posterior mitral leaflet having heart. the torn chord), as described above in connection with

FIGS. 10-14." (15:6-12.) 12. The method of claim Downing discloses that "[t]he suture placement 11, wherein the apical device 61 then can be fired into the papillary muscle tissue is internal to the PM. The free ends of the suture then can be brought heart. through the edge of the operative mitral leaflet (here,

in FIG. 17, the anterior mitral leaflet, although, in reality, it is usually the posterior mitral leaflet having

. the torn chord), as described above in connection with

58


13. The method of claim 11, wherein the apical tissue is a papillary muscle, a papillary connective tissue or an endocardial tissue in the lower ventricle.

20. The method of claim 19, wherein said accessing is done endovascularly via an antegrade approach. and 21. The method of claim 19, wherein said accessing is done endovascularly via a retrograde approach.

22. The method of claim 19, wherein said accessing is done via direct access through a transmyocardial approach. 23. The method of claim 19, wherein the replacing comprises anchoring a neochord to the apical region.

FIGS. 10-14." (15:6-12.) Downing discloses that "[t]he suture placement device 61 then can be fired into the papillary muscle PM. The free ends of the suture then can be brought through the edge of the operative mitral leaflet (here, in FIG. 17, the anterior mitral leaflet, although, in reality, it is usually the posterior mitral leaflet having the tom chord), as described above in connection with FIGS. 10-14." (15:6-12.) Downing discloses "the apparatuses and methods are compatible with several types of diagnostic and surgical techniques, including mitral valve repair, repair of atrial or ventricular septal defects, endovascular aortic surgery, and electrophysiologic studies." (3 :38--42.)

Downing Fig. 17 illustrates accessing the heart through a transmyocardial approach.

Oz discloses that "the device is introduced into the thoracic cavity and subsequently into the left ventricle through the apex." (8:5-7.) Downing discloses that "[t]he suture placement device 61 then can be fired into the papillary muscle PM. The free ends of the suture then can be brought through the edge of the operative mitral leaflet (here, in FIG. 17, the anterior mitral leaflet, although, in reality, it is usually the posterior mitral leaflet having the tom chord), as described above in connection with FIGS. 10-14." (15:6-12.)

To the extent the limitations of dependent claims 14-15 and 17-18 may not

be disclosed in Downing and Oz, the limitations of these claims are disclosed in

59

Petition for Inter Partes Review ofU.S. Patent 7,635,386

Lattouf I as cited above in section VI(C)(1) and given that the claims relate to

alternative procedures well known in the art that could be enacted with the

combination of Downing and Oz with no more than routine skill in the art, these

claims would have been obvious over Downing and Oz further in view of Lattouf

I. Ex.1011, ~87; Ex.1004, 3:60-62 (claim 14), 8:41-45 (claim 15 and 17) and 9:27-

29 (claim 18).

VII. Conclusion

Based on the foregoing, claims 1-23 of the '386 Patent are anticipated and

made obvious both by art that was before the Examiner, but mischaracterized by

Patent Owner or not discussed during prosecution, and art that was not before the

Examiner. This prior art establishes a reasonable likelihood that Petitioner will

prevail on at least one claim. Petitioner therefore requests institution of an inter

partes review to cancel the claims ofthe '386 Patent.

Dated: November 18, 2015 Respectfully submitted,

~b:

60

Brad D. Pedersen Reg. No. 32,432 Attorney for Petitioner

neochord, inc

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