UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

DEPUY SYNTHES SALES, INC. and

DEPUY SYNTHES PRODUCTS, INC.,

Petitioners

v.

Patent Owner of U.S. Patent No. 6,099,531 to Bonutti

Appl. No. 09/137,443 filed Aug. 20, 1998 Issued Aug. 8, 2000

IPR Trial No. TBD

PETITION FOR INTER PARTES

REVIEW OF U.S. PATENT NO. 6,099,531 PURSUANT TO 35 U.S.C. § 312 AND 37 C.F.R. § 42.108

i

TABLE OF CONTENTS

Introduction ..............................................................................................1 I.

Mandatory Notices (37 C.F.R. § 42.8) ........................................................2 II.

Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) ..................................2 A.

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

Lead and Back-up Counsel (37 C.F.R. § 42.8(b)(3)) ..........................4 C.

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

Fee Payment Authorization (37 C.F.R. § 42.103) ........................................5 III.

Grounds for Standing (37 C.F.R. § 42.104(a)) ............................................5 IV.

Identification of Challenge (37 C.F.R. § 42.104(b)) ....................................5 V.

Effective Filing Date of the ‘531 Patent ............................................5 A.

Prior Art and Statutory Grounds for the Challenge (37 C.F.R. § B.

42.104(b)) .......................................................................................6

U.S. Patent No. 6,008,433 to Stone et al. (“Stone”) (Ex. 1005) .6 1.

U.S. Patent No. 5,298,254 to Prewett et al. (“Prewett”) (Ex. 2.1006) .....................................................................................6

U.S. Patent No. 6,066,175 to Henderson et al. (“Henderson”) 3.

(Ex. 1007)..............................................................................7

U.S. Pat. No. 5,766,251 to Koshino (“Koshino”) (Ex. 1008) ....7 4.

French Patent Application No. FR 2,747,034 to Benezech et al. 5.(“Benezech”) (Ex. 1009) ........................................................7

French Patent Application No. FR 2,703,580 to Gilles 6.(“Gilles”) (Ex. 1011) ..............................................................8

Summary of the ‘531 Patent..................................................................... 10 VI.

Summary of the Patent ................................................................... 10 A.

Prosecution History of the ‘531 Patent ............................................ 12 B.

Level of Ordinary Skill in the Art ................................................... 12 C.

Claim Construction (37 C.F.R. § 42.104(b)(3)) ............................... 13 D.

“movable into the joint between first and second bones” ........ 14 1.

Detailed Explanation (37 CFR 42.104(b)(4)-(5))....................................... 15 VII.

ii

General State of the Art.................................................................. 15 A.

Ground 1 – The Challenged Claim Is Anticipated by Stone or, B.

Alternatively, Obvious over Stone in View of Prewett, Henderson and/or Koshino .............................................................................. 18

Ground 2 – The Challenged Claim is Obvious over Benezech in View C.of Gilles ........................................................................................ 32

Any Secondary Considerations of Nonobviousness Fail to Overcome D.the Strong Prima Facie Showing of Obviousness ............................ 41

Conclusion .............................................................................................. 41 VIII.

iii

TABLE OF AUTHORITIES

Cases Page(s)

Biomet Inc. v. Bonutti Skeletal Innovations LLC,

No. 13-176-JVB (N.D. In.) ............................................................................. 2

Bonutti Skeletal Innovations, LLC v. DePuy Synthes Sales, Inc. and

DePuy Synthes Products, Inc., No. 14-14680-IT (D. Mass.) ........................................................................... 2

Bonutti Skeletal Innovations LLC v. Globus Medical Inc., No. 14-6650-WB (E.D. Pa.)............................................................................ 2

In re ICON Health & Fitness, Inc., 496 F.3d 1374 (Fed. Cir. 2007) ..................................................................... 13

KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007) .................................................................... 21, 29, 37, 38

Nautilus, Inc. v. Bioig Instruments, Inc., 134 S.Ct. 2120 (2014) .................................................................................. 13

Ohio Willow Wood Co. v. Alps S., LLC,

735 F.3d 1333 (Fed. Cir. 2013) ..................................................................... 41

Pitney Bowes, Inc. v. Hewlett-Packard Co.,

182 F.3d 1298 (Fed. Cir. 1999) ............................................................... 18, 32

Q.I. Press Controls, B.V. v. Lee,

752 F.3d 1371 (Fed. Cir. 2014) ..................................................................... 41

In re Schreiber,

128 F.3d 1473 (Fed. Cir. 1997) ..................................................................... 15

Superior Indus., Inc. v. Masaba, Inc.,

553 F. App’x 986 (Fed. Cir. 2014) (Rader, concurring) .................................. 14

Statutes

35 U.S.C. § 102 et seq ..............................................................................1, 6, 7, 8

iv

35 U.S.C. § 103 .......................................................................................... 1, 8, 9

35 U.S.C. § 311 et seq. ........................................................................................ 1

35 U.S.C. § 314 .................................................................................................. 1

Other Authorities

37 C.F.R. § 42.1 et seq. ....................................................................................... 1

37 C.F.R. § 42.8 et seq .................................................................................... 2, 4

37 C.F.R. § 42.10(b) ........................................................................................... 4

37 C.F.R. § 42.15(a)............................................................................................ 5

37 C.F.R. §§ 42.22(a)(1) and 42.104(b)(1)-(2)...................................................... 5

37 C.F.R. § 42.100(b)........................................................................................ 13

37 C.F.R. § 42.103 .............................................................................................. 5

37 C.F.R. § 42.104 et seq ..........................................................................5, 6, 13

37 C.F.R. § 42.108 .............................................................................................. 1

37 C.F.R. §§ 42.104(B)(4)-(5) ........................................................................... 15

M.P.E.P. § 2111.02 ..................................................................................... 18, 32

M.P.E.P § 2114(II)...................................................................................... 14, 15

v

EXHIBIT LIST

Exhibit No. Description Short Reference

1001 U.S. Patent No. 6,099,531 the ‘531 patent

1002 Declaration of Dr. Carl McMillin McMillin Decl.

1003 Curriculum Vitae of Dr. Carl McMillin McMillin CV

1004 List of Prior Art and Other Materials

Considered by Dr. Carl McMillin

McMillin Materials

Considered

1005 U.S. Patent No. 6,008,433 Stone

1006 U.S. Patent No. 5,298,254 Prewett

1007 U.S. Patent No. 6,066,175 Henderson

1008 U.S. Patent No. 5,766,251 Koshino

1009 French Patent Application No. FR

2,747,034

Benezech

1010 Certified translation of French Patent Application No. FR 2,747,034 to

Benezech et al.

Benezech Translation

1011 French Patent Application No. FR

2,703,580

Gilles

1012 Certified translation of French Patent Application No. FR 2,703,580 to Gilles

et al.

Gilles Translation

1013 U.S. Patent Application No. 09/137,443

1014 Office Action, dated August 20, 1999

1015 Amendment, dated October 28, 1999

1016 Notice of Allowability, dated February

3, 2000

1017 Decision Denying Institution of Inter

Partes Review, IPR2015-01346

1018 Decision Instituting Inter Partes Review, IPR2015-01339

vi

FIGURES AND TABLES

Figure No. Description

1 Figure 2 of the ‘531 Patent

2 Figure 9 of the ‘531 Patent

3 Curvature of the Spine

4 Wedge-shaped intervertebral implant with two passages (annotated)

5 Figure 3C of Stone and Figure 2 of ‘531 Patent

6 Figure 6 of Prewett

7 Figure 1A of Stone (annotated)

8 Figure 1A of Stone

9 Illustration of Stone disclosure of plurality of passages

10 Figure 10 of the ‘531 Patent

11 Figure 1 of Koshino

12 Figure 2 of Benezech (annotated)

13 Figure 1 of Gilles (annotated)

14 Figure 1 of Gilles (annotated)

15 Figure 2 of Benezech

16 Figure 1 of Gilles

Table No. Description

1 Grounds for Inter Partes Review

2 Ground 1 – The Challenged Claim Is Anticipated by Stone or, Alternatively, Obvious Over Stone in View of Prewett, Henderson

and/or Koshino

3 Ground 2 – The Challenged Claim Is Obvious Over Benezech in View of Gilles

1

INTRODUCTION I.

Pursuant to 35 U.S.C. § 311 et seq. and 37 C.F.R. § 42.1 et seq., DePuy

Synthes Sales, Inc. and DePuy Synthes Products, Inc. (“Petitioners”), hereby

submit this petition for inter partes review (“Petition”) of U.S. Patent

No. 6,099,531 (“the ‘531 patent”), attached hereto as Ex. 1001. Petitioners

respectfully submit that Independent Claim 105 (the “Challenged Claim”) is

unpatentable under 35 U.S.C. § 102 and/or § 103 in view of the prior art discussed

herein.

The Challenged Claim is directed to a wedge for use in a patient’s

body. There was nothing novel about the Challenged Claim as of August 20, 1998,

the earliest effective filing date of the ‘531 patent. The wedge is one of the six

simple machines used since the dawn of civilization and, as the prior art presented

in this Petition demonstrates, orthopedic and spine surgeons had been using

wedge-shaped implants for decades. The only additional element of the

Challenged Claim are openings in the wedge to enable bone to grow through the

wedge. This was standard practice in the orthopedic and spinal implant art as of

1998.

Accordingly, Petitioners respectfully request that the Board institute an inter

partes review of the ‘531 patent pursuant to 35 U.S.C. § 314 and

37 C.F.R. § 42.108.

2

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

Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) A.

Petitioners are the real party-in-interest. The following corporations are

related to Petitioners: Johnson & Johnson; Johnson & Johnson International;

DePuy Synthes, Inc.; Synthes, Inc.; DePuy Orthopaedics, Inc.; Codman &

Shurtleff, Inc.; DePuy Products, Inc.; Synthes USA, LLC; DePuy Spine, LLC.

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

The following litigation matter would affect or be affected by a decision in

this proceeding: Bonutti Skeletal Innovations, LLC v. DePuy Synthes Sales, Inc.

and DePuy Synthes Products, Inc., No. 14-14680-IT (D. Mass.) (“the Pending

Litigation”). The litigation involves six patents: the ‘531 patent, U.S. Patent

No. 6,423,063 (“the ‘063 patent”), U.S. Patent No. 7,001,385 (“the ‘385 patent”),

U.S. Patent No. 8,486,066 (“the ‘066 patent”), U.S. Patent No. 8,690,944, and U.S.

Patent No. 8,795,363 (“the ‘363 patent”). Certain claims of the ‘531 patent are the

subject of this Petition. Petitioners are a party to the Pending Litigation.

The following litigation matters would also affect or be affected by a

decision in this proceeding: Bonutti Skeletal Innovations LLC v. Globus Medical

Inc., No. 14-6650-WB (E.D. Pa.) and Biomet Inc. v. Bonutti Skeletal Innovations

LLC, No. 13-176-JVB (N.D. In.). Both litigation matters involve the ‘531 patent.

Petitioners are concurrently filing four additional petitions for inter partes

3

review that will address (i) certain claims of the ‘063 patent, (ii) certain claims of

the ‘385 patent, (iii) certain claims of the ‘066 patent and (iv) certain claims of the

‘363 patent. The ‘063 patent and the ‘385 patent are related to the ‘531 patent

through continuation practice. Petitioners understand that all five patents are

owned by Bonutti Skeletal Innovations LLC.

On December 16, 2105, the Patent Trial and Appeal Board (“the Board”)

denied institution of IPR2015-01346, which included the Challenged Claim of the

‘531 patent. The petitioner asserted Stone in combination with Prewett, and the

Board held that Stone’s disclosure of porous surfaces is not a disclosure of “a

plurality of passages which extend between said first and second major side

surfaces for enabling bone to grow through said wedge member.” As discussed

below, however, the petitioner and Patent Owner both failed to point the Board to

the relevant portions of the Stone specification that contain explicit disclosures of

passages that extend between the surfaces and enable the bone to grow through the

wedge.

Furthermore, as Dr. McMillin explains and as discussed below, the Board’s

reasoning that bone graft inserted inside the wedge of Stone would effectively

block the wedge’s passages (Ex. 1017, p. 16) is incorrect because such passages,

like the passages of the ‘531 patent, are designed to promote bone fusion through

the wedge, and the inclusion of bone graft in the passages would have been the

4

preferred and obvious design choice to the person of ordinary skill. Moreover, the

Challenged Claim is an apparatus claim and therefore, even under the Board’s

reasoning, Stone’s instruction to use its wedge by filling it with bone graft does not

negate that the wedge itself is hollow and has unobstructed passages.

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

Petitioners designate the following as lead and back-up counsel, all with

Axinn, Veltrop & Harkrider LLP:

Lead Counsel Back-up Counsel

Jeremy Lowe, Reg. No. 48,085 90 State House Square, 9

th Floor

Hartford, CT 06103 Tel: 860-275-8100

Fax: 860-275-8101 jlowe@axinn.com

Dan Feng Mei, Reg. No. 71,518 114 West 47

th Street, 22

nd Floor

New York, NY 10036 Tel: 212-728-2200

Fax: 212-728-2201 dmei@axinn.com

Matthew J. Becker, Reg. No. 40,507

90 State House Square, 9th

Floor Hartford, CT 06103

Tel: 860-275-8100 Fax: 860-275-8101

mbecker@axinn.com

David K. Ludwig, Reg. No. 69,377

90 State House Square, 9th

Floor Hartford, CT 06103

Tel: 860-275-8100 Fax: 860-275-8101

dludwig@axinn.com

A power of attorney is submitted herewith pursuant to 37 C.F.R. § 42.10(b).

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

Service of any documents via hand-delivery may be made at the postal

mailing addresses of lead and back-up counsel identified above with courtesy

copies to the following email addresses: jlowe@axinn.com, mbecker@axinn.com,

dmei@axinn.com and dludwig@axinn.com. Petitioners consent to electronic

5

service at these same email addresses.

FEE PAYMENT AUTHORIZATION (37 C.F.R. § 42.103) III.

In accordance with 37 C.F.R. § 42.103(a), Petitioner authorizes the Patent

Office to charge Deposit Account No. 013050 for the fees set forth in 37 C.F.R.

§ 42.15(a). If payment of additional fees is due during this proceeding, the Patent

Office is authorized to charge such fees to Deposit Account No. 013050, and credit

any overpayment to the same account.

GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)) IV.

Pursuant to 37 C.F.R. § 42.104(a), Petitioners certify that the ‘531 patent is

eligible for inter partes review and that Petitioners are not barred or estopped from

requesting such review.

IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(b)) V.

Pursuant to 37 C.F.R. §§ 42.22(a)(1) and 42.104(b)(1)-(2), Petitioners

respectfully request inter partes review of the Challenged Claims and request that

the challenged claims be cancelled.

Effective Filing Date of the ‘531 Patent A.

The ‘531 patent was filed as Appl. No. 09/137,443 on August 20, 1998, and

did not claim priority to any earlier-filed application. For purposes of the Petition

only, the earliest effective filing date of the Challenged Claims is August 20, 1998.

The ‘531 patent issued on August 8, 2000.

6

Prior Art and Statutory Grounds B.for the Challenge (37 C.F.R. § 42.104(b))

U.S. Patent No. 6,008,433 to Stone et al. (“Stone”) (Ex. 1005) 1.

U.S. Patent No. 6,008,433 (“Stone”) (Ex. 1005) entitled “Osteotomy Wedge

Device, Kit and Methods for Realignment of a Varus Angulated Knee” was filed

on April 23, 1998. Stone is prior art to the ‘531 patent under 35 U.S.C. § 102(e)

because it was filed before the effective filing date (August 20, 1998) of the

‘531 patent but issued after the ‘531 patent. A detailed description of Stone is set

forth in Dr. McMillin’s declaration. (Ex. 1002 at ¶ 49.) Stone was not disclosed

by Applicants nor cited or applied by the Examiner during prosecution of the

‘531 patent.

U.S. Patent No. 5,298,254 to 2.Prewett et al. (“Prewett”) (Ex. 1006)

U.S. Patent No. 5,298,254 to Prewett at al. (“Prewett”) (Ex. 1006), entitled

“Shaped, Swollen Demineralized Bone and Its Use in Bone Repair,” issued on

March 29, 1994 and is prior art to the ‘531 patent under 35 U.S.C. § 102(b)

because it issued or published more than one year before the earliest effective

filing date (August 20, 1998) of the ‘531 patent. A detailed description of Prewett

is set forth in Dr. McMillin’s declaration. (Ex. 1002 at ¶ 54.) Prewett was not

disclosed by Applicants nor cited or applied by the Examiner during prosecution of

the ‘531 patent.

7

U.S. Patent No. 6,066,175 to 3.Henderson et al. (“Henderson”) (Ex. 1007)

U.S. Patent No. 6,066,175 to Henderson et al. (“Henderson”) (Ex. 1007),

entitled “Fusion Stabilization Chamber,” was filed on June 9, 1998. Henderson is

prior art to the ‘531 patent under 35 U.S.C. § 102(e) because it was filed before the

effective filing date (August 20, 1998) of the ‘531 patent but issued after the

‘531 patent. A detailed description of Henderson is set forth in Dr. McMillin’s

declaration. (Ex. 1002 at ¶ 50.) Henderson was not disclosed by Applicants nor

cited or applied by the Examiner during prosecution of the ‘531 patent.

U.S. Pat. No. 5,766,251 to Koshino (“Koshino”) (Ex. 1008) 4.

U.S. Pat. No. 5,766,251 to Koshino (“Koshino”) (Ex. 1008), entitled

“Wedge-Shaped Spacer for Correction of Deformed Extremities,” issued on June

16, 1998. Koshino is prior art under 35 U.S.C. § 102(a) because it issued before

the effective filing date (August 20, 1998) of the ‘531 patent. A detailed

description of Koshino is set forth in Dr. McMillin’s declaration. (Ex. 1002 at

¶ 51.) Koshino was disclosed by Applicants during prosecution of the ‘531 patent.

French Patent Application No. 5.

FR 2,747,034 to Benezech et al. (“Benezech”) (Ex. 1009)1

French Patent Application No. FR 2,747,034 to Benezech et al.

(“Benezech”) (Ex. 1013), entitled “Intersomatic Setting and Fusion System,”

1 A certified English translation of Benezech is attached as Ex. 1010.

8

published October 10, 1997. Benezech is prior art to the ‘531 patent under

35 U.S.C. § 102(a) because it is a printed publication in the U.S. or a foreign

country before the effective filing date (August 20, 1998) of the ‘531 patent. A

detailed description of Benezech is set forth in Dr. McMillin’s declaration.

(Ex. 1002 at ¶ 52.) Benezech was not disclosed by Applicants nor cited or applied

by the Examiner during prosecution of the ‘531 patent.

French Patent Application 6.No. FR 2,703,580 to Gilles (“Gilles”) (Ex. 1011)

2

French Patent Application No. FR 2,703,580 to Gilles (“Gilles”) (Ex. 1015),

entitled “Cervical Intersomatic Cage”, published on October 14, 1994. Gilles is

prior art to the ‘531 patent under U.S.C. § 102(b) because it is a printed publication

in the U.S. or a foreign country more than one year before the effective filing date

(August 20, 1998) of the ‘531 patent. A detailed description of Gilles is set forth

in Dr. McMillin’s declaration. (Ex. 1002 at ¶ 53.) Gilles was not disclosed by

Applicants nor cited or applied by the Examiner during prosecution of the

‘531 patent.

Table 1. Grounds for Inter Partes Review

Ground Claim Statutory Basis and Prior Art

1 105 Anticipation under 35 U.S.C. § 102 over Stone or obviousness under 35 U.S.C. § 103 over Stone in view of

2 A certified English translation of Gilles is attached as Ex. 1012.

9

Prewett, Henderson and/or Koshino

2 105 Obviousness under 35 U.S.C. § 103 over Benezech in view of

Gilles

These grounds are described in detail in Section VII below, and are supported by

the declaration of Carl McMillin, Ph.D. (Ex. 1002).

Dr. McMillin received a B.A. in Mechanical Engineering in 1969 from the

General Motors Institute of Technology and a Ph.D. from Case Western Reserve

University in macromolecular science and operations research in 1974. From 1983

to 1989, Dr. McMillin was an Associate Professor in the Department of

Biomedical Engineering and Director of the Cardiovascular Laboratory in the

Institute for Biomedical Engineering Research at the University of Akron. From

1989 to 1997, he was Senior Scientist, Director of Polymer Laboratory and

Director of R&D at AcroMed Corporation, developing orthopedic implant

products, primarily for spinal applications. Since 1999, Dr. McMillan has been a

member of the adjunct faculty at Cleveland State University teaching courses

including Biomaterials, Artificial Organs and Medical Devices, and Cardiovascular

Complications of Diabetes in the doctoral Applied Biomedical Engineering

Program. He is the recipient of the 2015 C. William Hall lifetime achievement

award from the Society for Biomaterials. As a skilled practitioner in the relevant

field since before 1998, Dr. McMillin is qualified to provide an opinion as to what

a person of ordinary skill in the art would have understood, known or concluded as

10

of August 20, 1998, the earliest-effective filing date of the ‘531 patent.

Accordingly, he is competent to testify in this proceeding.

SUMMARY OF THE ‘531 PATENT VI.

Summary of the Patent A.

The ‘531 patent specification provides a method and apparatus for changing

a spatial relationship between adjacent bones by inserting a wedge member into the

joint between the bones. (Ex. 1001 at 1:48-50.) As depicted below in Figure 1

(which is Figure 2 of the ‘531 patent), the wedge member applies a force to the

adjacent bones as it is moved into the joint, thus changing the spatial relationship

between the bones. (Id. at 1:52-56; 2:42-45; Fig. 2.)

Figure 1: Wedge member inserted into joint

The ‘531 patent specification describes various implantable wedge members.

11

For example, the wedge member may be porous and/or have passages extending

between the upper and lower surfaces in order to allow bone to grow through it.

(Id. at 10:1-8; Fig. 9.) This can be seen in Figure 2 (which is Figure 9 of the

‘531 patent).

Figure 2: Porous wedge member

The ‘531 patent specification further describes that the wedge member may

be fixedly connected to the bones with screws. (Id. at 7:41-63; Fig. 9.) Once the

wedge member is inserted into the joint, it is immediately capable of transmitting

force between the bones. (Id. at 7:36-40.)

The ‘531 patent issued with 129 claims of which independent claim 105 is

the only claim at issue in this Petition.

12

Prosecution History of the ‘531 Patent B.

The application that issued as the ‘531 patent was originally filed with

51 claims. (Ex. 1013 at 54-69.) On August 20, 1999, the Examiner rejected each

of claims as either obvious in view of U.S. Patent No. 5,690,635 (“Michelson”),

obvious over U.S. Patent No. 5, 906, 616 (“Pavlov”) or obvious over Michelson in

view of U.S. Patent No. 5,258,031 (“Salib”). (Ex. 1014 at 2-4.)3

On October 28, 1999, Applicant cancelled claims 1-32 and 40-51 and added

claims 52-173. (Ex. 1015 at 1-38.) Regarding claim 149, which issued as

independent claim 105 (the Challenged Claim), Applicant argued that it was

patentable over the prior art because it required the wedge member to have first

and second major side surfaces (e.g., the top and bottom surfaces of the wedge

member) which intersect to form an edge at a thin end portion and a minor side

surface that extends between the first and second major side surfaces and extends

from the thick end portion to the thin end portion. (Id. at 74.) On February 3,

2000, the Examiner issued a Notice of Allowability. (Ex. 1016 at 1.) The Notice

did not provide the Examiner’s reasons for allowance. (Id.)

Level of Ordinary Skill in the Art C.

A person of ordinary skill in the with respect to the ‘531 patent would have a

3 Dr. McMillin describes Michelson, Pavlov and Salib in his declaration. (Ex.

1002 at ¶¶ 37, 38 and 48.)

13

Bachelor’s or equivalent degree in Mechanical Engineering or a related discipline

(e.g. biomechanics or biomedical engineering), and at least five years of

experience, or a Ph.D. and at least two years of experience. (Ex. 1002 at ¶ 56.)

The experience would consist of a) designing, developing, evaluating and/or using

prosthetic devices, b) anatomy, physiology and biology of soft and calcified tissues

including bone healing and fusion, and c) biomechanical and functional loading of

orthopedic implants. (Id.) Alternatively, a person of ordinary skill would be a

Doctor of Medicine who has completed an accredited residency program in

orthopedic surgery followed by at least two years in active practice specializing in

orthopedic surgery. (Id. at ¶ 55.)

Claim Construction (37 C.F.R. § 42.104(b)(3)) D.

Petitioners do not concede that the scope of the terms construed or other

terms in the claims are reasonably certain to one of ordinary skill in the art. See

generally Nautilus, Inc. v. Bioig Instruments, Inc., 134 S.Ct. 2120 (2014). Rather,

Petitioners believe that many of the terms are indefinite and reserve all rights to

argue indefiniteness in the related litigation.

A patent claim term in inter partes review is to be given the “broadest

reasonable construction in light of the specification” as commonly understood by

those of ordinary skill in the art. 37 C.F.R. § 42.100(b). The terms are given a

broad interpretation except where defined otherwise in the specification. In re

14

ICON Health & Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007). Consistent

with this standard, and without conceding that these terms should be construed the

same way in a district court proceeding, Petitioners provide proposed constructions

of certain claim terms below for the purpose of this Petition only.

“movable into the joint between first and second bones” 1.

The Challenged Claim is directed to an apparatus comprising a wedge

member. The body of the claim contains the recitation that the wedge member is

“movable into the joint between the first and second bones.” In its December 16,

2015 Decision Instituting Inter Partes Review of IPR2015-01339, the Board held

that the similar term “configured and dimensioned for insertion into [a/the] joint”

in apparatus claims 1 and 14 of the related ‘385 patent “are intended-use

limitations or functional limitations that are not material to patentability because

they do not structurally distinguish the claimed apparatus from Stone.” (Ex. 1018

at 15-16.) The term “movable into a joint between first and second bones” is

likewise an intended-use or functional limitation that is not material to patentability

over prior art that discloses the structural limitations of the claim.

It is black-letter patent law that “apparatus claims cover what a device is, not

what a device does.” M.P.E.P § 2114(II) (quoting Hewlett-Packard Co.v.Bausch

& Lomb Inc., 909 F.2d 1464, 1469 (Fed. Cir. 1990).) See also Superior Indus.,

Inc. v. Masaba, Inc., 553 F. App’x 986, 991 (Fed. Cir. 2014) (Rader, concurring).

15

Therefore, “[a] claim containing a ‘recitation with respect to the manner in which a

claimed apparatus is intended to be employed does not differentiate the claimed

apparatus from a prior art apparatus’ if the prior art apparatus teaches all the

structural limitations of the claim.” M.P.E.P § 2114(II) (quoting Ex parte Masham,

2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).) See also In re Schreiber, 128 F.3d

1473, 1477 (Fed. Cir. 1997) (“[T]he recitation of a new intended use for an old

product does not make a claim to that old product patentable.”) Thus, the

recitations of intended use or function in the Challenged Claim does not render it

patentably distinct over a prior art apparatus that discloses all of the structural

limitations of the claim.

DETAILED EXPLANATION (37 C.F.R. §§ 42.104(B)(4)-(5)) VII.

General State of the Art A.

The ‘531 patent is generally directed to an implantable wedge-shaped device

used for changing the spatial relationship between bones in the human body.

(Ex. 1002 at ¶ 24.) A person of ordinary skill in the art would have understood that

the field of such devices would include at least devices used in osteotomy and

spinal fusion procedures. (Id.)

Osteotomy is the surgical practice in which a bone is cut to shorten,

lengthen, or to change its alignment (e.g. to correct the shape of deformed bones).

(Ex. 1002 at ¶ 25.) To change the alignment, the surgeon can either cut out and

16

remove a wedged piece of bone and close the opening (a closing wedge osteotomy)

or can insert a wedge shaped piece of bone or implant into the opening (an opening

wedge osteotomy). (Id.) In a closing wedge osteotomy, the resulting site has bone

on bone contact and can fuse directly. (Id.) In an opening wedge osteotomy, the

wedge shaped implant can be filled with bone marrow, bone chips or other bone

inducing materials to promote bone formation and fusion. (Id.) This procedure

was well-known to a person of ordinary skill in the art as of August 20, 1998.

(Id.)

A common form of spinal fusion involves the fusion of two adjacent

vertebra, a procedure that is often done to restore the normal curvature of the spine.

(Id. at ¶ 30.)

Figure 3: Curvature of the spine

The normal curvature of the spine consists of lordosis (segments creating a

17

backward-leaning curve) in the cervical region, kyphosis (segments creating a

forward-leaning curve) in the thoracic region and lordosis again in the lumbar

region and is generated by both wedge-shaped vertebral bodies and wedge-shaped

spinal discs. (Id. at ¶ 27.)

As of August 20, 1998, the use of wedge-shaped spinal implants to stabilize

and fuse vertebrae was common practice. (Id. at ¶ 32.) As early as the 1950s,

decompression – the removal of the intervertebral disc located between adjacent

vertebrae – together with the implantation of a bone graft in the resulting space had

been established as a standard method of accomplishing stabilization and fusion.

(Id.) Between 1990 and 1998, over one million spinal fusions were performed in

hospitals throughout the U.S. (Id. at ¶ 33.) At this time, spinal implants designed

to fuse two vertebrae typically contained one or more passages for insertion of

bone graft material through which bone growth could occur. (Id. at ¶ 36.) The

illustration below shows a wedge-shaped vertical ring implant with two openings

for bone graft material that was in use in the early 1990s. (Id.)

18

Figure 4: Wedge-shaped intervertebral implant with two passages (annotated)

Ground 1 – The Challenged Claim Is Anticipated by Stone or, B.

Alternatively, Obvious over Stone in View of Prewett, Henderson and/or Koshino

The features of Challenged Claim are recited in the headings of sub-

paragraphs (1) though (4) below. The Challenged Claim is directed to “[a]n

apparatus”:

“for use in changing the spatial relationship between first 1.and second bones which are interconnected at a joint in a

patient’s body”

The preamble of Challenged Claim 105 is not limiting as it merely states the

intended use of the claimed apparatus. Pitney Bowes, Inc. v. Hewlett-Packard Co.,

182 F.3d 1298, 1305 (Fed. Cir. 1999); M.P.E.P. § 2111.02. To the extent that the

preamble does limit the Challenged Claim, however, Stone discloses “a device . . .

for the correction of varus angulated knees including the genu varus and genus

valgus conditions.” (Ex. 1005 at 1:6-9; see also Figs 3A-C.) A person of ordinary

skill in the art would thus understand that Stone discloses an implantable device for

19

use in changing the spatial relationship between bones that are interconnected at a

joint. (Ex. 1002 at ¶ 58.)

a wedge member which is movable into the joint between 2.the first and second bones

As discussed in the Claim Construction section above, the recitation that the

wedge member be “movable into the joint between the first and second bones”

does not render the claim patentably distinct over a prior art device if that device is

capable of being moved into a joint. (Supra at 14-15.) Here, as illustrated by

Figure 5 below, and as explained by Dr. McMillin, the wedge of Stone is

indistinguishable from the wedge embodiments of the ‘531 patent and is thus

capable of being inserted into a joint between two bones. (Ex. 1002 at ¶ 59.)

Figure 5: Fig. 2 of ‘531 Patent and Fig. 3C of Stone

Even if the term “movable into the joint between the first and second bones”

were material to patentability, it would have been obvious to a person of skill in

20

the art that the wedge of Stone could be inserted into an intervertebral joint in view

of Prewett. (Ex. 1002 at ¶ 60.) Prewett discloses a demineralized bone cut into

“wedges [that] can be used as in[ter]vertebral support blocks.” (Ex. 1006 at 6:66-

7:3.) Figure 6 below (which is Figure 6 of Prewitt), “illustrate[s] one of the

wedges being inserted between adjacent vertebrae in a spinal column in place of an

in[ter]vertebral disk that has been removed.” (Id. at 7:2-6.)

Figure 6: Teaching of Prewett to insert wedge into vertebral joint

The person of ordinary skill in the art would have understood that Prewett,

like Stone, discloses an implantable spacer that is shaped like a wedge. (Ex. 1002

at ¶ 60.) In view of Prewett’s teaching that a wedge-shaped implant is suitable for

insertion into a vertebral joint, the person of skill would have understood that the

21

wedge-shaped implant of Stone would be equally suitable. (Id.) The person of

skill would have further understood that using the wedge of Stone in this way

would not have altered the principle of operation of the wedge, and doing so would

have predictably yielded the same effect as the wedge of Prewett. (Id.) It was

therefore obvious to the person of skill to insert the wedge of Stone into a joint in

view of Prewett. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007).

“said wedge member having a thin end portion, a thick end 3.portion a first major side surface which extends from said

thin end portion to said thick end portion, a second major side surface which intersects said first major side surface to form an edge at said thin end portion and extends from said

thin end portion to said thick end portion a minor side surface which extends between said first and second major

side surfaces and tapers from said thick end portion to said thin end portion”

Stone discloses “osteotomy devices and kits . . . [that] involve substantially

wedge-shaped bodies having . . . principal surfaces adapted to engage

mechanically [sic] surfaces such as bone . . . .” (Ex. 1005 at 2:62-65.)

22

Figure 7: The wedge member of Stone (annotations added)

(Id. at Fig. 1A.)

As seen in Figure 7 (which is Figure 1A of Stone), Stone discloses a wedge

member having (1) a thin end portion, (2) a thick end portion, (3) a first major side

surface which extends from said thin end portion to said thick end portion, (4) a

second major side surface which intersects said first major side surface to form (5)

an edge at said thin end portion and extends from said thin end portion to said thick

end portion, and (6) a minor side surface which extends between said first and

second major side surfaces and tapers from said thick end portion to said thin end

portion. (Ex. 1002 at ¶ 61.) Thus, Stone discloses a wedge member having each

of the above limitations. (Id.)

23

“said wedge member having a plurality of passages which 4.extend between said first and second major side surfaces for

enabling bone to grow through said wedge member.”

Stone discloses that the body of its wedges “can be hollow.” (Ex. 1005 at

7:8-9.) Stone further discloses that “such a body include[s] a plurality of holes on

the principal surface. . . .” (Id. at 7:12-14.) Stone identifies the top and bottom

surfaces of the body as the “intersecting principal surfaces 112, 114,” as illustrated

in Figure 8 below:

Figure 8: Principle Surfaces of Stone (112, 114)

(Id. at 5:29-30; Fig. 1A.) Stone further discloses that “the diameters of [the] holes

can range from about 2 mm to about 10 mm,” and that the length of the body can

range from “about 20 mm to about 100 mm. . . .” (Id. at 5:54-57; 7:52-54.)

Therefore, as Dr. McMillin explains, the person of ordinary skill in the art would

understand that Stone discloses a wedge with multiple openings on the top and

24

bottom surfaces that are connected through the hollow body. (Ex. 1002 at ¶ 62.)

Figure 9 below illustrates this disclosure:

Figure 9: Illustration of Stone disclosure of plurality of passages

(Id.)

Stone further discloses that the hollow body can be packed with ground

cancellous bone before insertion into a patient. (Ex. 1005 at 7:8-9.) As Dr.

McMillin explains, the person of ordinary skill would understand that the purpose

of the ground cancellous bone is to stimulate the growth of the patient’s own bone

(osteogenesis) and thereby facilitate fusion. (Ex. 1002 at ¶ 63.) The ground

cancellous bone can only serve this purpose if it receives a blood supply from the

patient’s own bone. (Id.) Absent access to the blood vessels on the surfaces of the

25

patient’s bone, the cancellous bone in the body of the wedge would become useless

fibrous material that would do nothing to encourage bone growth. (Id.) Therefore,

as the person of ordinary skill would understand, the hollow embodiment of Stone

is only operational with openings in the top and bottom surfaces through which

bone can grow. (Id.) Stone therefore discloses a wedge member having a plurality

of passages which extend between said first and second major side surfaces for

enabling bone to grow through said wedge member. (Id.)

In denying institution of IPR2015-01346, the Board agreed with the Patent

Owner that Stone’s disclosure of “porous material on the principal surfaces(s) of

the device” does not disclose a plurality of passages extending between the major

sides of the device. (Ex. 1017, at 16.) As explained above, however, Stone

explicitly teaches a plurality of passages and the hollow wedge of Stone would not

be operational absent such a plurality of passages.

Furthermore, the board’s interpretation of “a plurality of passages” in the

Challenge Claim is contrary to the disclosure in the ‘531 patent that the wedge

member can be hollow, filled with bone growth inducing material and have a

plurality of passages extending between the major side surfaces. (Ex. 1002 at

¶ 64.) Discussing the embodiment of Figure 10 below (Figure 10 of the ‘531

patent) where “the wedge member [] is hollow” and filled with bone growth

inducing material, the specification states that “the wedge member 44b is formed

26

of a porous material which enable[s] bone to grow through the wedge member. . . .

However, it should be understood that the wedge member 44b could be formed of

a solid material with passages drilled or cast in the wedge member.” (Ex. 1001 at

11:50-59; Fig. 10.)

Figure 10: Embodiment of ‘531 patent with hollow wedge member filled with bone growth inducing material and including passages

Thus, according to the ‘531 patent, the fact that a wedge member is hollow and

filled with a material does not preclude the wedge member from having “a

plurality of passages which extend between said first and second major side

surfaces for enabling bone to grow through said wedge member.” (Ex. 1002 at

¶ 64.)

Moreover, as Dr. McMillin explains, the “porous material” on the surfaces

of the device of Stone is distinct from the “plurality of holes” on the surfaces.

(Ex. 1002 at ¶ 65.) This is demonstrated by Stone’s disclosures of the difference in

27

sizes of the pores and the holes. (Id.) Whereas the “pores can range in size from

about 50 micrometers to about 500 micrometers,” (Ex. 1005 at 6:36-68), “the

diameters of [the] holes can range from about 2 mm to about 10 mm.” (Id. at 7:52-

54.) Thus, as Dr. McMillin concludes, the pores and the holes are different

structural features of Stone’s device. (Ex. 1002 at ¶ 65.) Therefore, even if the

person of skill would not have understood Stone’s disclosure of a hollow body and

porous surfaces to disclose a plurality of passages, Stone’s disclosure of a hollow

body and a plurality of “holes” on the top and bottom surfaces does disclose a

plurality of passages. Dr. McMillin therefore concludes that the Board erred in

finding that the person of ordinary skill would not read Stone as disclosing a

plurality of passages extending between the major sides of the device. (Id.)4

4 The Board also stated that “it is unclear how having the body 110 ‘packed’ with

cancellous bone would even allow for the existence of passages within it and

extending between the holes on principle surfaces.” (Ex. 1017, at 16.) As Dr.

McMillin explains, however, the cancellous bone is only inserted in the wedge at

the time of the operation. (Ex. 1002 at ¶ 63.) Thus, even if Stone instructs users of

the wedge to block the passages with cancellous bone, Stone still teaches a

plurality of passages because the passages are present and unobstructed until the

wedge is used.

28

Alternatively, Dr. McMillin explains that it would have been obvious to the

person of ordinary skill in the art to add such plurality of passages to the wedge of

Stone. (Id. at ¶ 66.) Such passages were well-known in both the spinal and

osteotomy art at the time and were used to allow bone material placed in the body

of an implant to have access to the blood supply on the surfaces of the patient’s

bones so that osteogenesis and fusion could occur. (Id.) For example, Henderson

discloses a hollow fusion stabilization chamber with “walls having openings which

permit bone growth from the adjacent vertebrae, through the interior of the

chamber.” (Ex. 1007 at 3:25; 5:55-57.) Henderson teaches that the chamber may

be filled with “cancellous bone.” (Id. at 7:17-19.) Similarly, Koshino discloses a

wedge-shaped osteotomy device with “1 to 6 holes 5 through which the upper

surface 2 and lower surfaces 3 are connected to each other.” (Ex. 1008 at 5:22-31.)

Figure 11: Fig. 1 of Koshino

Koshino teaches that the holes are used for insertion of the small bone chips, and

that “the growth of bone is accelerated” by the bone chips. (Id. at 5:32-36.)

29

As Dr. McMillin explains, the person of ordinary skill would have been

motivated to add a plurality of passages extending between the major surfaces to

the wedge of Stone to enable bone to grow through the wedge. (Ex. 1002 at ¶ 67.)

It was well-known to the person of ordinary skill that, as taught by Koshino, the

addition of bone fragments in openings in an implant accelerates bone growth and

thus fusion. (Id.) It would have been routine for the person of skill to add such

passages as taught by Henderson and Koshino, and the person of skill would have

reasonably expected to succeed in doing so. (Id.) It would therefore have been

obvious to the person of ordinary skill in the art to add a plurality of passages

extending between the major side surfaces for enabling bone to grow through the

wedge of Stone. (Id.) See KSR, 550 U.S. at 416.

Thus, as further illustrated in Table 2 below, Stone, or Stone in view of

Prewett, Henderson and/or Koshino, disclose all the elements of the Challenged

Claim and anticipate it or render it obvious.

30

Table 2. Ground 1 – the Challenged Claim is Anticipated by Stone or Obvious Over Stone in View of Prewett, Henderson and/or Koshino

Challenged Claim 105 Stone (Ex. 1005), Prewett (Ex. 1006)

Henderson (Ex. 1007), Koshino (Ex. 1008)

An apparatus for use in changing the spatial relationship between

first and second bones which are interconnected at a joint in a

patient’s body, said apparatus comprising

Not material to patentability.

“The present invention relates to a device, a kit and methods for tibial realignment, and in

particular, to a device, kit and methods for the correction of varus angulated knees including

the genu varus and genus valgus conditions.” (Stone Ex. 1005 at 1:6-9.)

a wedge member which is movable into the joint between

the first and second bones,

Not material to patentability.

“For example, FIGS. 5 and 6 illustrate one of the wedges 8 being inserted between adjacent

vertebrae 9 and 10 in a spinal column 11 in place of an intervertebral disk that has been

removed. More specifically, FIG. 6 illustrates insertion of the wedge 8 in the direction of

arrow A by forceps 12” (Prewett Ex. 1006 at 7:2-8; Fig. 6.)

Figure 6: Fig. 6 of Prewett

31

said wedge member having a thin end portion, a thick end portion, a first major side surface

which extends from said thin end portion to said thick end portion,

a second major side surface which intersects said first major

side surface to form an edge at said thin end portion and extends

from said thin end portion to said thick end portion, and a minor

side surface which extends between said first and second

major side surfaces and tapers from said thick end portion to

said thin end portion,

Figure 8: Fig. 1A of Stone

said wedge member having a

plurality of passages which extend between said first and

second major side surfaces for enabling bone to grow through

said wedge member.

“In yet another embodiment, the body 110 of

the osteotomy device of the present invention can be hollow. Accordingly, materials such as

ground cancellous bone can be packed within the body 110. Further, such a body 110 include

a plurality of holes on the principal surface which can facilitate packing of material within

the body 110.” (Stone Ex. 1005 at 7:12-14.)

“The fusion stabilization chamber of the present invention includes a pair of hollow members, both of which may have a

rectangular or slightly trapezoidal cross-section.” (Henderson Ex. 1007 at 3:25-28.)

“One prefers walls having openings which permit bone growth from the adjacent

vertebrae, through the interior of the chamber.” (Id. at 5:55-57.)

“Also, the wedge-shaped spacer 1 of the

present invention usable for . . . osteotomies . . . is provided with at least one, preferably 1 to 6

holes 5 through which the upper surface 2 and

32

lower surfaces 3 are connected to each other. The holes 5 are used for insertion of the small bonechips of the patient thereinto which are

able to be obtained around the osteotomy site. When a wedge-shaped spacer 1 having the

small bonechips inserted into the holes 5 is inserted into the osteotomized portion, the

growth of bone is accelerated within a relatively short period so that the new bone

formation of the inserted bonechips and the bone tissue located above and below the

wedge-shaped spacer 1 are accelerated and these bones are united easily with each other.”

(Koshino Ex. 1008 at 5:22-40.)

Ground 2 – The Challenged Claim is C.

Obvious over Benezech in View of Gilles

The features of Challenged Claim are recited in the headings of sub-

paragraphs (1) though (4) below. The Challenged Claim is directed to “[a]n

apparatus”:

“for use in changing the spatial relationship between first 1.and second bones which are interconnected at a joint in a

patient’s body”

The preamble of Challenged Claim 105 is not limiting as it merely states the

intended use of the claimed apparatus. See Pitney Bowes, 182 F.3d at 1305;

M.P.E.P. § 2111.02.

“a wedge member which is movable into the joint between 2.the first and second bones”

As discussed in the Claim Construction section above, the recitation that the

33

wedge member be “movable into the joint between the first and second bones”

does not render the claim patentably distinct over a prior art device if that device is

capable of being moved into a joint. (Supra at 14-15.) Here, Benezech discloses

“an intersomatic vertebrae setting and fusion system . . . intended to be interposed

between two vertebrae.” (Ex. 1010 at 1:6-8.) It is this thus capable of being

moved into a joint between two bones. (Ex. 1002 at ¶ 70.)

“said wedge member having a thin end portion, a thick end 3.portion a first major side surface which extends from said

thin end portion to said thick end portion, a second major side surface which intersects said first major side surface to form an edge at said thin end portion and extends from said

thin end portion to said thick end portion a minor side surface which extends between said first and second major

side surfaces and tapers from said thick end portion to said thin end portion”

Figure 12 below demonstrates that Benezech discloses a wedge member

having each of these limitations except a minor side surface that tapers from the

thick end portion to the thin end portion:

34

Figure 12: Wedge member of Benezech (annotations added)

(Ex 1010 at Fig. 2; Ex 1002 at ¶ 71.) As can be seen, Benezech discloses a wedge

shaped intervertebral implant having: (1) a thin end portion, (2) a thick end

portion, (3) a first major side surface which extends from said thin end portion to

said thick end portion, (4) a second major side surface which intersects said first

major side surface to form (5) an edge at said thin end portion and extends from

said thin end portion to said thick end portion. (Ex. 1002 at ¶ 71.)

It would have been obvious to modify Benezech to provide a minor side

surface that tapers from the thick end portion to the thin end portion in view of

Gilles. Gilles discloses a “[c]ervical intersomatic cage” for “fusion of vertebrae

during discectomy. . . .” (Ex. 1012, cover page.) As the title suggests, the cage of

35

Gilles is intended for fusion of vertebrae located in the cervical region of the spine.

(Id. at 1:7-8; 2:25; Ex. 1002 at ¶ 72.) The cage is shaped as a wedge with a minor

side surface having a height that lowers over its entire length from the thick end

portion to the thin end portion:

Figure 13: Cage of Gilles (annotated)

Gilles teaches that “[t]he height of the posterior face (6) is sufficient to enable the

preservation of a normal cervical height [and that] [t]he height of the anterior face

(5) is slightly greater to make it possible to obtain the appropriate degree of

lordosis.” (Id. at 2:25:27.) Moreover, the cage is designed “to ensure the

preservation of an intervertebral space and a normal lordosis.” (Id. at 1:32-34.)

In denying institution of IPR2015-01346, the Board held that it would not

have been obvious to modify the shape of the cage in Benezech because of the

statement in Benezech that “the shape and particular profile of the cage 1A

according to the example of figure 2 allow for a perfect adaptation to the

36

intervertebral space.” (Ex. 1017 at p. 8 (citing Ex. 1010 at 5:4-6).) As Dr.

McMillin explains, however, Benezech’s general reference to “the intervertebral

space” would not have suggested to the person of ordinary skill that the specific

profile of Figure 2 would be ideal for every intervertebral space of every patient.

(Ex. 1002 at ¶ 74.) On the contrary, the person of ordinary skill would know that

every patient presents a different spinal anatomy and that the intervertebral spaces

have significant geometries depending upon the patient’s condition and the specific

area of the spine requiring intervention. (Id.) Thus, Benezech itself teaches that

the cage “can have different dimensions in terms of height, width and depth. It can

also have . . . a preferred anatomical shape.” (Ex. 1010 at 4:9-12.)

Furthermore, there is no disclosure in Benezech that its “intersomatic

vertebrae setting and fusion system” is intended for use in a specific region of the

spine. (Ex. 1002 at ¶ 75.) As Dr. McMillin explains, a person of ordinary skill in

the art would therefore have understood that Benezech could be favorably

modified for specific areas of the spine. (Id.) To provide a cervical setting and

fusion system, the person of ordinary skill would therefore have been motivated to

look to the teaching in Gilles of a cage directed specifically at the cervical area.

(Id.) Adding the tapered minor side surface of Gilles to Benezech would a have

been routine to the person of ordinary skill in the art, and produced the predictable

result of providing an intervertebral fusion system adapted for the cervical area.

37

(Id.) Combining the teachings of Benezech and Gilles thus represents nothing

more than an obvious combination of one known spinal implant design with

another known spinal implant design to achieve predictable results. KSR, 550 U.S.

at 418.

“said wedge member having a plurality of passages which 4.extend between said first and second major side surfaces for

enabling bone to grow through said wedge member.”

As discussed above, Gilles discloses a wedge-shaped “intersomatic cage”

intended for fusion of vertebrae located in the cervical region of the spine. (Supra

at 34-35.) The cage has “a median partition (2) serving as reinforcement,”

(Ex. 1012 at 2:21), as seen in Figure 14 below:

Figure 14: Cage of Gilles (annotated)

Gilles further teaches that “[b]y confining the cancellous bone, the cage

favors permanent bone fusion.” (Id. at 2:16.) Gilles thus discloses a wedge

member with a plurality of passages which extends between first and second major

38

side surface for enabling bone to grow through said wedge member. (Ex. 1002 at

¶ 77.)

As discussed above, the person of ordinary skill seeking to provide an

intersomatic fusion cage specifically for the cervical region of the spine would

have been motivated to modify Benezech with the teachings of Gilles. (Supra at

34-37.) As Dr. McMillin explains, the person of ordinary skill in the art would

have known that adding the median partition of Gilles to Benezech would not only

serve to reinforce the cage and increase its structural integrity, but also decrease

the likelihood that the cage would subside into the bottom vertebra over time by

increasing the surface area of the cage. (Id. at ¶ 78.) It would have been routine

for the person of ordinary skill to add the median partition of Gilles to Benezech,

and doing so would have had the predictable result of providing an intersomatic

fusion system suited for the cervical area of the spine. (Id.) Combining the

teachings of Benezech and Gilles thus represents nothing more than an obvious

combination of one known spinal implant design with another known spinal

implant design to achieve predictable results. KSR, 550 U.S. at 418.

Thus, as further illustrated in Table 3 below, Benezech in view of Gilles

disclose all the elements of the Challenged Claim and render it obvious.

39

Table 3. Ground 2 –

The Challenged Claim is Obvious Over Benezech in View of Gilles

Challenged Claim 105 Benezech (Ex. 1010) and Gilles (Ex. 1012)

An apparatus for use in changing the spatial

relationship between first and second bones which are

interconnected at a joint in a patient’s body, said apparatus

comprising

Not material to patentability.

“[A]n intersomatic vertebrae setting and fusion system . . . intended to be interposed between two

vertebrae.” (Benezech Ex. 1010 at 1:6-8.)

a wedge member which is movable into the joint between the first and second bones,

Not material to patentability. “[A]n intersomatic vertebrae setting and fusion

system . . . intended to be interposed between two vertebrae.” (Benezech Ex. 1010 at 1:6-8.)

40

said wedge member having a thin end portion, a thick end portion, a first major side

surface which extends from said thin end portion to said

thick end portion, a second major side surface which

intersects said first major side surface to form an edge at said

thin end portion and extends from said thin end portion to

said thick end portion, and a minor side surface which

extends between said first and second major side surfaces

and tapers from said thick end portion to said thin end portion,

Figure 15: Fig. 2 of Benezech

“Its anterior face (5) and posterior face (6) have heights that are determined to ensure the

preservation of an intervertebral space and a normal lordosis.” (Gilles Ex. 1012 at 1:33-34.)

Figure 16: Fig. 1 of Gilles

said wedge member having a plurality of passages which

extend between said first and second major side surfaces for

enabling bone to grow through said wedge member.

“By confining the cancellous bone, the cage favors permanent bone fusion.” (Gilles Ex. 1012

at 2:1, 16.)

Figure 16: Fig. 1 of Gilles

41

Any Secondary Considerations of Nonobviousness Fail to D.

Overcome the Strong Prima Facie Showing of Obviousness

Petitioners are not aware of any evidence of secondary considerations of

nonobviousness such as unexpected results, commercial success, long-felt but

unsolved needs or failure of others to achieve the claimed apparatus. Even if the

Patent Owner could somehow present a secondary consideration of

nonobviousness, however, it could not render the Challenged Claim non-obvious

in view of the strength of the prima facie obviousness case demonstrated by the

prior art discussed in this Petition. See, e.g., Q.I. Press Controls, B.V. v. Lee, 752

F.3d 1371, 1380 (Fed. Cir. 2014) (finding relevant secondary considerations not

outweighing the prima facie case of obviousness); Ohio Willow Wood Co. v. Alps

S., LLC, 735 F.3d 1333, 1344 (Fed. Cir. 2013) (“[W]here a claimed invention

represents no more than the predictable use of prior art elements according to

established functions, as here, evidence of secondary indicia are frequently deemed

inadequate to establish non-obviousness.”)

CONCLUSION VIII.

Petitioners submit that issues have been presented that demonstrate a

reasonable likelihood that the Challenged Claim of the ‘531 patent is unpatentable

as obvious. Petitioners therefore request that the Board grant inter partes review to

cancel this claim.

42

Respectfully submitted,

AXINN, VELTROP & HARKRIDER, LLP

Dated: December 28, 2015

By: /Jeremy Lowe/ Jeremy Lowe, Registration No. 48,085

Matthew J. Becker, Registration No. 40,507 David K. Ludwig, Reg. No. 69,377

Axinn, Veltrop & Harkrider, LLP 90 State House Square

Hartford, CT 06103 Tel: (860) 275-8100

Dan Feng Mei, Registration No. 71,518

Axinn, Veltrop & Harkrider, LLP 114 West 47 Street New York, NY 10036

Tel: (212) 728-2210

Customer No. 067272

Attorneys for Petitioners DePuy Synthes Sales, Inc. and DePuy Synthes

Products, Inc.

1

CERTIFICATE OF SERVICE

I hereby certify that a true and correct coy of PETITION FOR INTER

PARTES REVIEW OF U.S. PATENT No. 6,099,531 PURSUANT TO

35 U.S.C. § 312 and 37 C.F.R § 42.108 was served on December 28, 2015via

FedEx Priority Overnight service to the corresponding address for the subject

patent pursuant to 37 C.F.R § 42.105:

Peter M. Bonutti

1303 W. Evergreen Plz Effingham, IL 62401

Cheryl Willeford

500 Newport Center Drive, 7th

Floor

Newport Beach, CA 92660

In addition, a courtesy copy of the above was sent to opposing counsel in the

litigation at issue via email/[FedEx Priority Overnight] addressed as follow:

Kevin Gannon (BBO# 640931)

kgannon@hayesmessina.com Hayes Messina Gilman & Hayes, LLC

200 State Street 6th Floor Boston, MA 02109

(617) 345-6900

John M. Desmarais

jdesmarais@desmaraisllp.com Laurie Stempler

lstempler@desmaraisllp.com DESMARAIS LLP 230 Park Avenue

New York, NY 10169 Telephone: (212)-351-3400

Facsimile: (212)-351-3401

Dated: December 28,

2015

By: /Jeremy Lowe/

Jeremy Lowe Registration No. 48,085

jlowe@axinn.com

2

Axinn, Veltrop & Harkrider, LLP 90 State House Square

Hartford, CT 06103 Tel: (860) 275-8100

Customer No. 067272

Attorney for Petitioners

DePuy Synthes Sales, Inc. and DePuy Synthes Products, Inc.