Filed on behalf of Petitioners Jason M. Honeyman WOLF ...Filed on behalf of Petitioners . By: Michael N. Rader Paper No. __ Jason M. Honeyman . Richard F. Giunta . Jennifer J. Wang

Filed on behalf of Petitioners By: Michael N. Rader Paper No. __ Jason M. Honeyman Richard F. Giunta Jennifer J. Wang WOLF, GREENFIELD & SACKS, P.C. 600 Atlantic Avenue Boston, MA 02210 Tel: (617) 646-8000 Fax: (617) 646-8646 [email protected]

UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD

_____________

SMITH & NEPHEW, INC. & ARTHROCARE CORPORATION

Petitioners

v.

ARTHREX, INC. Patent Owner

_____________

Case No. TBD Patent No. 6,511,499

_____________

PETITION FOR INTER PARTES REVIEW UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.1 et seq.

- i -

TABLE OF CONTENTS I. INTRODUCTION ............................................................................................. 1

II. MANDATORY NOTICES ............................................................................... 5

A. Real Parties-In-Interest (37 C.F.R. § 42.8(b)(1)) ........................................ 5

B. Related Matters (37 C.F.R. § 42.8(b)(2)) .................................................... 5

C. Counsel and Service Information (37 C.F.R. § 42.8(b)(3)-(4)) .................. 6

III. NOTICE OF FEES PAID .................................................................................. 6

IV. CERTIFICATION OF GROUNDS FOR STANDING .................................... 6

V. IDENTIFICATION OF CHALLENGE AND RELIEF REQUESTED ........... 7

A. Technology Background ............................................................................. 7

B. Overview of the Challenged Claims ........................................................... 9

1. Screw Features ...................................................................................... 9

2. Suture Anchor Features .......................................................................10

C. Prosecution History ...................................................................................11

1. The ’162 (Grandparent) and ’031 (Parent) Patents .............................11

2. The ’499 Patent (Containing the Challenged Claims) ........................12

D. Prior Art .....................................................................................................13

1. Schmieding ..........................................................................................13

2. Rosenberg ’463 File ............................................................................14

3. Stone and Goble ..................................................................................15

4. Nazre ....................................................................................................16

5. Huebner ...............................................................................................16

E. Level of Ordinary Skill in the Art .............................................................17

F. Statutory Grounds for Challenge ...............................................................17

VI. CLAIM INTERPRETATION .........................................................................18

A. Preambles (All Independent Claims) ........................................................19

B. Outer and Inner Thread Diameter (All Independent Claims) ...................20

VII. APPLICABLE PRIORITY DATE ..................................................................24

- ii -

VIII. THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW ...............28

IX. CLAIM-BY-CLAIM EXPLANATION OF GROUNDS FOR UNPATENTABILITY OF CLAIMS 1-4 AND 8-16 .....................................28

A. Ground 1: Schmieding Anticipates Claims 1-4 and 8-16 .........................28

B. Grounds 2A and 2B: Rosenberg ’463 File Renders Claims 1-4 and 8-16 Unpatentable......................................................................................34

1. Rosenberg ’463 File Discloses All Screw Features ............................34

2. Ground 2A: Rosenberg ’463 File Anticipates Claims 1, 4, 8, 11, 12, 13, and 16 ......................................................................................39

a. Claims 1, 8, and 12 ...................................................................... 39

b. Claim 13 ...................................................................................... 43

c. Claims 4, 11, and 16 .................................................................... 44

3. Ground 2B: Rosenberg ’463 File in View of Stone Renders Claims 1-4 and 8-16 Obvious ..............................................................44

a. Claims 1, 4, 8, 11-13, and 16 ...................................................... 44

b. Claims 2, 9, and 14 ...................................................................... 46

c. Claims 3, 10, and 15 .................................................................... 48

C. Ground 3: Nazre in View of a POSA’s Knowledge Renders Claims 8-12 and 14-16 Obvious ............................................................................49

1. Independent Claims 8 and 12 ..............................................................50

2. Dependent Claims 9-11 and 14-16 ......................................................57

D. Ground 4: Nazre in View of Huebner and the Knowledge of a POSA Renders Claims 1-4 and 13 Obvious ..............................................58

X. CONCLUSION ................................................................................................60

- iii -

TABLE OF AUTHORITIES CASES

Abbott Labs. v. Baxter Pharma. Prods., Inc., 471 F.3d 1363 (Fed. Cir. 2006) ......................................................... 19, 22, 36, 50

AFG Inds. v. Cardinal IG Co., 239 F.3d 1239 (Fed. Cir. 2001) ..................................................................... 40, 54

Am. Med. Sys., Inc. v. Biolitec, Inc., 618 F.3d 1354 (Fed. Cir. 2010) ............................................................................20

Atas Int’l v. Centria, IPR2013-00259, slip op. (Sept. 24, 2013) ............................................................38

Bruckelmyer v. Ground Heaters, 445 F.3d 1374 (Fed. Cir. 2006) ............................................................................14

Chester v. Miller, 906 F.2d 1574 (Fed. Cir. 1990) ............................................................................30

Eiselstein v. Frank, 52 F.3d 1035 (Fed. Cir. 1995) ..............................................................................26

Eli Lilly & Co. v. L.A. Biomedical Research Institute, IPR2014-00693, 2014 WL 5462679 (PTAB Oct. 23, 2014) ...............................26

EMI Group N. Am., Inc. v. Intel Corp., 157 F.3d 887 (Fed. Cir. 1998) ..............................................................................19

Ex Parte Deacon, Appeal 2003-1272, 2005 WL 4755435 (BPAI June 2, 2005) ..............................25

Ex parte Delaite, Appeal No. 2009-004953, 2010 WL 1607501 (BPAI Apr. 19, 2010) .................27

Ex parte Denis, Appeal 2011-011705, 2013 WL 5400168 (PTAB Jan. 22, 2013) ......................38

Ex parte Farnworth, Appeal No. 2006-2181, 2006 WL 2230047 (BPAI) ............................................27

- iv -

Ex parte George, 230 USPQ 575 (BPAI 1984) ................................................................................25

Ex parte Hoang, Appeal 2013-007488, 2015 WL 4940443 (PTAB Aug. 17, 2015) ......................37

Ex Parte Lemay, Appeal 2008-0786, 2008 WL 4371689 (BPAI Sept. 24, 2008) ...........................35

Ex parte Mauler, Appeal 2012-008098, 2013 WL 4397015 (PTAB Aug. 14, 2013) ......................37

Ex parte Sato, 2014 WL 1154010 (PTAB Mar. 20, 2014) ..........................................................37

Ex parte Scott, Appeal No. 1997-1498, 2001 WL 863732 (BPAI) .............................................26

Ex Parte Stephenson, Appeal 2009-014158, 2011 WL 2693003 (BPAI July 8, 2011) .........................35

Ex parte Tosaka, Appeal No. 2008-3927, 2008 WL 5192432 (BPAI Dec. 10, 2008) ....................26

Ex parte Wang, Appeal 2009-005165, 2009 WL 3497077 (BPAI Oct. 28, 2009) .......................38

Ex parte Woo, Appeal 2012-004629, 2014 WL 5511419 (PTAB Oct. 30, 2014) .......................40

Hormone Research Foundation, Inc. v. Genentech, Inc., 904 F.2d 1558 (Fed. Cir. 1990) ............................................................................41

In re Aslanian, 590 F.2d 911 (CCPA 1979) ..................................................................................34

In re Blaser, 556 F.2d 534 (CCPA 1977) ........................................................................... 25, 27

In re Huang, 100 F.3d 135 (Fed. Cir. 1996) ..............................................................................18

- v -

In re Lukach, 442 F.2d 967 (CCPA 1971) ..............................................................................2, 30

In re Mraz, 455 F.2d 1069 (CCPA 1972) ......................................................................... 37, 51

In re Wertheim, 541 F.2d 257 (CCPA 1976) ..................................................................................27

Lee v. Dayton-Hudson, 838 F.2d 1186 (Fed. Cir. 1988) ............................................................................38

Lockwood v. Am. Airlines, Inc., 107 F.3d 1565 (Fed. Cir. 1997) ............................................................................24

Purdue Pharma L.P. v. Faudling Inc., 230 F.3d 1320 (Fed. Cir. 2000) ............................................................................26

Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F. 2d 1570 (Fed. Cir. 1985) ...........................................................................25

Rolls-Royce v. United States, 339 F.2d 654 (CCPA 1964) ..................................................................................13

SAP America, Inc. v. Arunachalam, IPR2014-00414, 2015 WL 4941753 (PTAB Aug. 17, 2015) ..............................24

Summit 6, LLC v. Samsung Elecs. Co., 802 F.3d 1283 (Fed. Cir. 2015) ..................................................................... 19, 20

Volkswagen Group of Am., Inc. v. Signal IP, Inc., 2015 WL 6690118 (PTAB Oct. 29, 2015) ...........................................................19

STATUTES

35 U.S.C § 102(e) ....................................................................................................16

35 U.S.C. § 102(b) ...................................................................................... 13, 15, 17

35 U.S.C. § 103(a) ...................................................................................................17

35 U.S.C. § 112 ................................................................................................. 24, 30

35 U.S.C. § 314(a) ...................................................................................................28

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35 U.S.C. §§ 311–19 .................................................................................................. 1

37 C.F.R. § 1.14(a)(2) ..............................................................................................13

37 C.F.R. § 1.152 .....................................................................................................39

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

37 C.F.R. § 42.100(b) ..............................................................................................18

37 C.F.R. § 42.104(a) ................................................................................................. 6

37 C.F.R. § 42.8(b)(1) ................................................................................................ 5

37 C.F.R. § 42.8(b)(2) ................................................................................................ 5

37 C.F.R. § 42.8(b)(3)-(4) .......................................................................................... 6

OTHER AUTHORITIES

MPEP § 1503.02 ......................................................................................................39

MPEP § 714.01(e) ....................................................................................................25

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PETITIONERS’ EXHIBITS Exhibit Description

1001 U.S. Patent No. 6,214,031 (“the ’031 patent”)



1004 File History of U.S. Provisional Application No. 60/023,011

1005 File History of U.S. Patent Application No. 08/905,393

1006 File History of U.S. Patent 6,117,162

1007 File History of U.S. Patent No. 6,214,031






1013 U.S. Patent No. 5,851,219 (“Goble”)

1014 U.S. Patent Application No. 08/393,553

1015 U.S. Patent No. D331,463

1016 File History of U.S. Patent No. D331,463 (“Rosenberg ’463 File”)

1017 U.S. Patent Application No. 08/954,206 (“Schmieding”)

1018 U.S. Patent No. 6,027,523

1019 U.S. Patent No. 5,100,417 (“Cerier”)

1020 U.S. Patent No. 5,120,171 (“Lasner”)

1021 U.S. Patent No. 5,139,520 (“Rosenberg”)

1022 U.S. Patent No. 5,370,662 (“Stone”)

1023 U.S. Patent No. 5,456,685 (“Huebner”)

1024 U.S. Patent No. 5,573,548 (“Nazre”)

- viii -

Exhibit Description

1025 U.S. Patent No. 4,569,338 (“Edwards”)

1026 U.S. Patent No. 5,697,950 (“Fucci”)

1027 U.S. Patent No. 4,250,674 (“Feist”)

1028 Barber et al., “Suture Anchor Failure Strength – An In Vivo Study,” Arthroscopy: The Journal of Arthroscopic and Related Surgery 9(6):647-652 (1993) (“Barber 1993”)

1029 Barber et al., “The Ultimate Strength of Suture Anchors,” Arthroscopy: The Journal of Arthroscopic and Related Surgery 11(1):21-28 (Feb. 1995) (“Barber 1995”)

1030 Barber et al., “Internal Fixation Strength of Suture Anchors – Update 1997,” Arthroscopy: The Journal of Arthroscopic and Related Surgery 13(3):355-362 (June 1997) (“Barber 1997”)

1031 Chapman et al., “Factors Affecting the Pullout Strength of Cancellous Bone Screws,” Journal of Biomechanical Engineering 118:391-398 (August 1996)

1032 DeCoster et al., “Optimizing Bone Screw Pullout Force,” Journal of Orthopaedic Trauma 4(2):169-174 (1990)

1033 Hayes, “Biomechanics of Cortical and Trabecular Bone: Implications For Assessment of Fracture Risk,” Basic Orthopaedic Biomechanics, pp. 93-142 (1991)

1034 Perren et al., “Technical and biomechanical aspects of screws used for bone surgery,” International Journal of Orthopaedic Trauma 2(1):31-48 (1992)

1035 Tencer et al., “Biomechanics of Cannulated and Noncannulated Screws,” Cannulated Screw Fixation, pp. 15-40 (1996)

1036 Uhl, “The Biomechanics of Screws,” Orthopaedic Review 18(12):1302-1307 (December 1989)

1037 Excerpts, Academic Press Dictionary of Science and Technology (1992)

1038 Excerpts, Random House Unabridged Dictionary, Second Edition (1993)

- ix -

Exhibit Description

1039

Oberg et al., “Screw Threads,” Machinery’s Handbook: A Reference Book for the Mechanical Engineer, Manufacturing Engineer, Draftsman, Toolmaker, and Machinist, p.1633, Industrial Press Inc., New York, NY (1996)

1040 Exhibit 5 to Appendix B of Patent Owner’s 9/23/15 Infringement Contentions



1043 U.S. Patent No. 5,492,442

1044 Corrected Brief for Defendant-Cross Appellant Arthrex, Inc. in Mitek Surgical Products, Inc. v. Arthrex, Inc. (U.S. Court of Appeals for the Federal Circuit, Nos. 99-1004, 1034)

1045 Corkscrew Product Sheet from Arthrex Catalog 1998-1999 (“Catalog”)

1046 Asnis et al., “Cancellous Bone Screw Design and Holding Power,” 62nd Annual Meeting of American Academy of Orthopaedic Surgeons, pp. 465-466 (February 1995)

1047 U.S. Patent No. 74,489 (“Bidwell”)

1048 U.S. Patent No. 2,787,186 (“Brogiotti”)

1049 United States Court of Appeals for the Federal Circuit, Rules of Practice (March 4, 1999)

1050 U.S. Patent No. 4,601,625 (“Ernst”)

1051 U.S. Patent No. 4,892,429 (“Giannuzzi”)

1052 U.S. Patent No. 4,988,351 (“Paulos”)

1053 U.S. Patent No. 5,059,077 (“Schmid”)

1054 U.S. Patent No. 5,792,142 (“Galitzer”)

1055 U.S. Patent No. 4,693,654 (“Bettini”)

1056 U.S. Patent No. 6,117,162

- x -

Exhibit Description

1057 Declaration of Alexander Slocum, Ph.D.

1058 Curriculum vitae of Alexander Slocum, Ph.D.

1059 Declaration of Joseph Sklar, M.D.

1060 Curriculum vitae of Joseph Sklar, M.D.

1061 Mitek Surgical Products, Inc. v. Arthrex, Inc., 21 F. Supp. 2d 1309 (D. Utah 1998)

1062 Mitek Surgical Products, et al. v. Arthrex Inc. Civ No. 96-CV-87 (D. Utah) (Case Docket)

1063 Federal Rules of Appellate Procedure (effective Dec. 1, 1998)

1064 Chapter 1500 Design Patents, Manual of Patent Examining Procedure, Rev. 4 (Oct. 1986)

1065 Subpart A— General Provisions , Manual of Patent Examining Procedure, Rev. 1 (Feb. 2000)

- 1 -

Pursuant to 35 U.S.C. §§ 311–19 and 37 C.F.R. § 42.1 et seq., Smith &

Nephew, Inc. and ArthroCare Corporation (“Petitioners”) request inter partes

review of claims 1-4 and 8-16 of U.S. Patent No. 6,511,499 (“the ’499 patent”).

I. INTRODUCTION

The ’499 patent (Ex. 1002) is directed to a screw-based “suture anchor” for

affixing suture to bone. Screw-based suture anchors were known in the prior art

years before the ’499 patent’s alleged priority date of August 5, 1996.

According to the ’499 patent, prior art suture anchors “may have …

inadequate ‘pull-out’ strength,” especially when used in soft (“cancellous”) bone.

(Ex. 1002 at 1:43-48). The ’499 patent alleges a need for a suture anchor that has

“exceptional pull-out strength, especially in soft bone” and can be “secured easily

and effectively” while “displac[ing] a minimum amount of bone upon insertion”

and being “averse to ‘backing out’ of the insertion site.” (1:60-67).

The ’499 patent addresses this ostensible problem by disclosing a suture

anchor with a tapered central body and a thread that spirals around the central body

and incorporates various purportedly novel features. (2:3-59). However, many of

these features—for example, thread pitch and “surface features” (2:38-59)—are

not included in any of the challenged claims. The features that do appear in the

challenged claims—related to thread depth and thickness—were known in the

prior art to improve holding power in cancellous bone.

- 2 -

Nevertheless, the ’499 patent purports to distinguish “known suture anchors”

on the ground that the invention “provide[s] an increased percentage of thread

surface area for each turn of the screw.” (2:28-35). In particular, it describes

“increasing the ratio of the outer diameter of the threads to the inner diameter,”

with a preferred ratio of “between 2.25 and 2.75.” (2:35-36.) All of the examples

described in the specification have ratios within this range.

However, the challenged claims all require a different and broader range,

i.e., “the outer diameter of the thread” is “at least twice the inner diameter of the

thread along a portion of the thread.” This broader range (i.e., “2.0 or higher”)

finds no support in any of the ’499 patent’s priority documents. The priority

documents only disclose a range of “between 2.25 and 2.75.”

Accordingly, the challenged claims are not entitled to any priority date

before the ’499 patent’s actual filing date of April 3, 2001. Therefore, Schmieding

(Ex. 1017)—one of the applications to which the ’499 patent claims priority—

constitutes § 102(b) prior art and anticipates all of the challenged claims.

Disclosing an outer-to-inner diameter ratio of “between 2.25 and 2.75” plainly

anticipates a ratio of “at least twice” even though it fails to demonstrate that the

inventors possessed the broader claimed range. In re Lukach, 442 F.2d 967, 968

(CCPA 1971) (disclosure of ratio of “2.6” anticipated claims to ratio of “2.0-3.0”

even though it was insufficient as a “claim-supporting disclosure”).

- 3 -

The challenged claims would also be unpatentable even if the Board found

that they were entitled to their earliest possible priority date of August 5, 1996.

There was nothing inventive about increasing thread surface area to improve

pullout strength. It was well known in the prior art that deeper threads increased

the holding power of screws in soft (cancellous) bone. Indeed, deep thread was

synonymous with “cancellous thread.” It was also known that increasing the

thickness of the outer edge of the thread toward the proximal end improved a

screw’s holding power and minimized damage to tissue.

Rosenberg ’463 File (Ex. 1016), which was not considered by the Examiner

during prosecution of the ’499 patent, discloses a screw-based suture anchor that

satisfies all of the screw-related limitations of the challenged claims—including

the outer-to-inner thread diameter ratio and proximally increasing thread thickness.

Rosenberg also discloses the remaining elements of claims 1, 4, 8, 11-13, and 16

and therefore anticipates these claims. These other limitations concern the eyelet

and drive head incorporated into the screw to make it a functional suture anchor.

Claims 2-3, 9-10, and 14-15 recite additional suture anchor features,

including (1) “channels for suture” on the drive head, and (2) “two lengths” of

suture attached to the anchor. These features were common in prior art anchors,

and a person of ordinary skill in the art (“POSA”) would have integrated them

when making and using a suture anchor as disclosed in Rosenberg ’463 File.

- 4 -

Nazre (Ex. 1024) discloses all of the limitations of the challenged claims

aside from the outer-to-inner diameter ratio and proximally increasing thread

thickness. Nazre emphasizes the value of having deep threads toward the distal

end of the suture anchor. A POSA would have optimized Nazre’s design such that

the outer thread diameter is “at least twice” the inner diameter along a portion of

the thread. Thread depth was a known, result-effective variable, and numerous

references not of record during prosecution disclosed outer-to-inner diameter ratios

of 2.0 or greater. Moreover, there is no evidence that any particular ratio was

critical or yielded results that were different in kind from prior art suture anchors.

A POSA also would have optimized Nazre’s design by increasing the

thickness of the thread toward the proximal end of the central body. This design

choice was known in the prior art and expressly disclosed in Huebner (Ex. 1023) as

well as Rosenberg ’463 File. Moreover, nothing in the ’499 patent suggests any

link between thread thickness and any other claim limitation. (Indeed, the only

two sentences mentioning thread thickness, see Ex. 1002 at 2:52-54, 4:13-16, were

added during prosecution to conform the specification to Figure 1.) These

disconnected disclosures fit the overall pattern of the ’499 patent, which recites a

litany of well-known screw and suture anchor features without any indication that

the combination was inventive and/or achieved any synergy beyond the predictable

results (e.g., increased holding strength) already documented in the prior art.

- 5 -

II. MANDATORY NOTICES

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

Smith & Nephew, Inc. and ArthroCare Corp. are the real parties-in-interest.

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

A decision in this proceeding could affect or be affected by the following:

(1) Petitioners are simultaneously filing petitions for inter partes review

of: claims 5-7 of the ’499 patent (which are similar to claims 1-4 and 8-16, but

include additional limitations directed to a driver for driving the anchor into bone),

as well as certain claims of U.S. Patent Nos. 6,214,031 (from which the ’499 patent

is a continuation) and 7,195,634 (which is a continuation of the ’499 patent). For

the sake of efficiency and consistency, Petitioners request that the Board assign a

single panel to address the five inter partes review petitions. The relevant issues

and prior art references are substantially similar across all five petitions.

(2) Patent Owner is presently asserting the ’031, ’499, and ’634 patents

against Petitioners (E.D. Tex. Case No. 2:15-cv-01047).

(3) Other issued patents and pending applications claiming the same

effective filing date as the ’499 patent include U.S. Patent Nos. 6,117,162 and

6,916,333, the ’031 patent, the ’634 patent, and Application Nos. 11/707,067

(subject of pending Appeal No. 2013-008985) and 12/963,102 (subject of pending

Appeal No. 2014-003693).

- 6 -

C. Counsel and Service Information (37 C.F.R. § 42.8(b)(3)-(4))

Lead Counsel Michael N. Rader (Registration No. 52,146)

Backup Counsel Jason M. Honeyman (Registration No. 31,624) Richard F. Giunta (Registration No. 36,149) Jennifer J. Wang (Registration No. 68,598)

Service Information E-mail: [email protected] [email protected] [email protected] [email protected] Post and hand delivery: Wolf, Greenfield & Sacks, P.C. 600 Atlantic Avenue Boston, MA 02210-2206 Telephone: 617-646-8000 Facsimile: 617-646-8646

Powers of attorney are submitted with this petition. Counsel for Petitioners

consents to service of all documents via electronic mail.

III. NOTICE OF FEES PAID

Fees are submitted herewith. If more fees are due during this proceeding,

the undersigned authorizes the office to charge Deposit Account No. 23/2825.

IV. CERTIFICATION OF GROUNDS FOR STANDING

Petitioners certify, pursuant to 37 C.F.R. § 42.104(a), that the ’499 patent is

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

from requesting inter partes review as to the claims identified herein.

- 7 -

V. IDENTIFICATION OF CHALLENGE AND RELIEF REQUESTED

A. Technology Background

Orthopedic surgeons sometimes need to affix suture to bone in order to re-

attach soft tissue to the bone or otherwise secure devices to the bone during

surgery. The ’499 patent (Ex. 1002) concerns a “threaded suture anchor” for

“anchoring surgical suture in bone,” particularly “cancellous bone.” (1:14-17).

Cancellous bone has a “lattice-like, or spongy” structure. (1:47-48).

As discussed in the declarations of Petitioners’ experts Dr. Joseph Sklar

(Ex. 1059) and Professor Alexander Slocum (Ex. 1057), screw-based anchors were

known in the prior art for affixing suture to cancellous bone. The ’499 patent

acknowledges such prior art anchors, but asserts that they “may have ... inadequate

‘pull-out’ strength,” especially in cancellous bone. (Ex. 1002 at 1:43-46).

As Dr. Sklar explains in his declaration, pull-out strength (i.e., the force

required to dislodge the anchor from the bone following insertion) was a well-

known performance criterion for suture anchors. (Sklar ¶¶ 45-46). For example, a

1995 article reviewed a series of screw-based anchors and tested pull-out strength

in cancellous bone. Certain suture anchors (e.g., the “Revo”) exhibited

consistently high pull-out strength. (Ex. 1029 at 27). In the vast majority (80%) of

cases, the Revo eventually failed because the suture “cut out” from the anchor

eyelet, not because the anchor pulled out of the bone. (Id. at 23).

- 8 -

The ’499 patent claims to provide a suture anchor with “increased pull-out

strength” by “increasing the ratio of the outer diameter of the threads to the inner

diameter of the threads.” (Ex. 1002 at 2:28-35).

However, it was known that screws with deeper threads have greater holding

power in cancellous bone as well as analogous materials such as foam and soft

wood. (Slocum ¶¶ 78-80; Sklar ¶¶ 116-120, 126). For example, the “deep threads”

of ordinary wood screws were known to be useful in either “wood or cancellous

bone.” (Ex. 1036 at 1304). One reason why is that deep threads “compress[] the

surrounding” material, increasing its “density” and thus its “holding strength.” Id.

It was also known that screws for insertion in foam should have even deeper

threads than conventional wood screws. (Ex. 1027 at 5:34-44). This design

maximized the amount of material “left between these deep thread courses,” thus

ensuring “secure holding of the screw.” (Id. at 9:44-47). Foam was a known

proxy for cancellous bone and was used to test suture anchors and other implants.

(Ex. 1031 at 392-94 ; Ex. 1033 at 98; Ex. 1035 at 23; Sklar ¶ 52).

The relationship between thread depth and the holding power of screws in

cancellous bone was so well known that deep threads were commonly known as

“cancellous threads.” (Ex. 1025 at 4:18-58 (touting “wide surface of contact with

the cancellous bone”); Ex. 1034 at 34-35 (“The screws with “deep thread” (for

cancellous bone Figure 8b) have a relatively (1:2) small core diameter.”)).

- 9 -

None of these references were considered during prosecution of the ’499

patent. The ’499 patent wrongly characterizes the relationship between screw

thread depth and holding power in cancellous bone as a new discovery that

distinguished the invention from the prior art. The ’499 patent also fails to suggest

any unexpected results associated with the preferred (but unclaimed) outer-to-inner

diameter ratio of “between 2.25 and 2.75.” Instead, the limited data provided in

the patent (4:57-5:15) and the provisional application (Ex. 1004 at 20-21) indicates

that the invention had less holding power than prior art screw-based anchors of

similar size. (Ex. 1029 at 25-26; Sklar ¶¶ 132-140; Slocum ¶¶ 173, 177-79).

B. Overview of the Challenged Claims

Claims 1-4 and 8-16 of the ’499 patent cover screw-based suture anchors

and incorporate two sets of claim limitations. One set (the “Screw Features”)

concerns attributes of the screw. The second set (the “Suture Anchor Features”)

concerns structures (e.g., a drive head and an eyelet) incorporated into the screw to

make it useful for anchoring suture.

1. Screw Features

Certain Screw Features appear in each of independent claims 1, 8, and 12.

All of the independent claims require (1) a central core that is threaded and

tapered; (2) a “tip” or “tip portion”; and (3) an outer thread diameter that is “at

least twice the inner diameter of the thread along a portion of the thread.”

- 10 -

Other Screw Features appear only in certain claims:

Proximally Increasing Thread Thickness. Claim 1 requires that “the outer

edge” of the thread have “a thickness” that increases “proximally along a portion

of the thread.” The specification refers to Figure 1 as illustrating this feature. (Ex.

1002 at 4:13-16). Dependent claim 13 includes a similar limitation, but concerns

the thickness of the thread generally rather than requiring that thickness increase

along the “outer edge.” The specification includes a second sentence that refers to

proximally increasing thread thickness generically and implies that it improves

pull-out strength. (Ex. 1002 at 2:52-54). As with increasing thread depth,

however, the correlation between proximally increasing thread thickness and pull-

out strength was known in the prior art.

Separately-Tapered Tip Portion. Claim 8 requires that the “tip portion” has

a conical shape” and “a taper that is greater than the taper of the major portion of

the central body.” The ’499 patent does not disclose any purpose for this feature.

However, it was known to facilitate screw insertion. (Slocum ¶ 70).

2. Suture Anchor Features

Independent claims 1, 8, and 12 specify that the drive head is “formed on the

proximal end of the central body.” Claims 1 and 8 use this same phrase to specify

eyelet location. Claim 12 requires that the eyelet be “formed on the drive head.”

These drive head and eyelet configurations were common in prior art anchors.

- 11 -

Various dependent claims recite additional Suture Anchor Features also

known in the prior art, such as “channels for suture” (claims 2, 9, and 14), “two

lengths of suture … attached to the suture anchor” (claims 3, 10, and 15), and a

“hexagonal” drive head (claims 4, 11, and 16).

C. Prosecution History

The ’499 patent is a continuation of the ’031 patent, which is a continuation

of the ’162 patent.

1. The ’162 (Grandparent) and ’031 (Parent) Patents

As originally filed, the ’162 patent specification did not refer to proximally-

increasing thread thickness. Patent Owner sought to amend the specification to

include the two sentences mentioned in Section V.B.1 above, but the Examiner

initially objected to the amendment as introducing new matter. (Ex. 1006 at 50).

The Examiner later entered the amendment after Patent Owner cited the “relative”

proportions in Figure 1 as constituting an “unambiguous disclosure of the

proximally increasing thickness of the thread.” (Id. at 64-65).

Patent Owner also amended the ’162 claims during prosecution. The claims

as filed required that “the ratio of the outer diameter of the thread to the inner

diameter of the thread” be “between about 2.25 and 2.75.” (Id. at 15-17). Patent

Owner later added the phrase “along a portion of the thread” without explaining

the meaning of the phrase, which never appears in the specification. (Id. at 81-83).

- 12 -

The Examiner rejected the claims because “[a] change in size is generally

recognized as being within the level of ordinary skill in the art.” (Id. at 97). In

response, Patent Owner narrowed the claims to require that the tip portion have a

“concave” surface, but broadened the outer-to-inner diameter ratio requirement.

(Id. at 101-104). Specfically, Patent Owner replaced the closed range of “between

about 2.25 and 2.75 along a portion of the thread” with the open-ended

requirement that the outer diameter of the thread be “at least twice” the inner

diameter “along a portion of the thread.” (Id).

The Examiner later allowed the ’162 patent claims with the concavity

requirement, which is absent from the’499 patent claims. (Id. at 115).

The ’031 patent issued without any substantive prosecution other than a

double-patenting rejection over the ’162 patent, followed by a terminal disclaimer.

2. The ’499 Patent (Containing the Challenged Claims)

The ’499 patent issued without any substantive prosecution other than a

double-patenting rejection over the ’162 and ’031 patents followed by terminal

disclaimers. (Ex. 1008 at 57-62). Patent Owner also amended the specification to

add the same two sentences regarding proximally-increasing thread thickness that

the Examiner had entered during prosecution of the ’162 patent after Patent Owner

cited the relative proportions of the threads illustrated in Figure 1. (Id. at 35).

- 13 -

D. Prior Art

1. Schmieding

Application No. 08/954,206 to Schmieding et al. (“Schmieding,” Ex. 1017)

became public on February 22, 2000 because it is incorporated by reference in U.S.

Patent No. 6,027,523, which issued that day. (Ex. 1018 at 1:36-39). At the time,

37 C.F.R. § 1.14(a)(2) provided that “[c]opies of an application-as-filed may be

provided to any person, upon written request accompanied by the fee set forth in §

1.19(b)(1), without notice to the applicant, if the application is incorporated by

reference in a U.S. patent.” (Ex. 1065). See also Rolls-Royce v. United States,

339 F.2d 654, 659 (CCPA 1964) (“[T]he contents of an abandoned application are

‘described in’ the referencing patent by virtue of a cross-reference.”).

Schmieding is prior art under pre-AIA 35 U.S.C. § 102(b)1 because claims

1-4 and 8-16 are not entitled to a priority date earlier than the actual April 3, 2001

filing date of the ’499 patent. See infra Section VII.

Schmieding issued as the ’162 patent (i.e., the ’499 patent’s grandparent)

and is virtually identical to the ’499 patent aside from the two sentences describing

proximally increasing thread thickness. As noted in Section V.C.1, though, Patent

Owner admits that Figure 1 provides an “unambiguous” depiction of “the relative

thickness between the proximal and distal flights of the thread.” (Ex. 1006 at 64).

1 All statutory citations are to pre-AIA versions, which apply here.

- 14 -

2. Rosenberg ’463 File

Rosenberg ’463 File (Ex. 1016) is the file history for U.S. Patent No.

D331,463, which issued on December 1, 1992 (Ex. 1015). Rosenberg ’463 File

thus became publicly available on December 1, 1992 and is § 102(b) prior art to

the ’499 patent. E.g., Bruckelmyer v. Ground Heaters, 445 F.3d 1374, 1379-80

(Fed. Cir. 2006) (Canadian file history constituted invalidating prior art).

As detailed in Section IX.B below, Rosenberg ’463 File includes drawings

that disclose a suture anchor with all of the Screw Features recited in all challenged

claims, and all of the Suture Anchor Features recited in all independent claims.

The applicant’s accompanying explanation in the file history confirms the accuracy

of the drawings. (Ex. 1016 at 16). The history also explains that the suture anchor

may be used “temporarily” during ACL reconstruction. (Id. at 15). This tracks the

’499 patent’s discussion of “procedures that require removal” of suture anchors.

(Ex. 1002 at 1:58-59). Rosenberg ’463 File’s anchor was also known to be useful

to secure soft tissue to bone. (Ex. 1024 at 1:9-58).

The entire file history, including the applicants’ statements, became prior art

on December 1, 1992, when the ’463 patent (Ex. 1015) issued. A POSA would

understand that applicants’ statements (Ex. 1016 at 15-16) and figures (id. at 33)

constitute a single disclosure; the statements concerned Examiner’s request for an

“explanation of the claimed design invention” (id. at 13).

- 15 -

3. Stone and Goble

U.S. Patent No. 5,370,662 to Stone (“Stone,” Ex. 1022) issued on December

6, 1994 and is § 102(b) prior art to the ’499 patent.

U.S. Patent No. 5,851,219 to Goble (“Goble,” Ex. 1013) is a file wrapper

continuation of Serial No. 08/393,553, which was filed on February 23, 1995.

Goble is therefore § 102(e) prior art even under the ’499 patent’s earliest possible

priority date of August 5, 1996. The February 1995 application (Ex. 1014) is

identical to Goble’s specification.

Stone and Goble each disclose threaded suture anchors incorporating all of

the Suture Anchor Features recited in the challenged ’499 patent claims, in a

fashion identical to the ’499 patent’s preferred embodiment, with the drive head

containing an internal eyelet as well as channels:

(Sklar ¶ 222; Slocum ¶¶ 50, 52, 190). Stone and Goble also both disclose using

two or more strands of suture. (Ex. 1022 at 2:8-19; Ex. 1013 at 3:19-20).

- 16 -

4. Nazre

U.S. Patent No. 5,573,548 to Nazre (“Nazre,” Ex. 1024) was filed on June 9,

1994 and is § 102(e) prior art to the ’499 patent. Nazre discloses a screw-based

suture anchor with a tapered central core, a tip portion having a greater taper, and a

thread having a constant outer diameter. As such, the threads are deepest toward

the distal end of the central core. Nazre teaches that this arrangement “increase[s]

the purchase of the threads distally … to increase attachment strength.” (2:35-43).

Nazre also discloses essentially all of the Suture Anchor Features recited in the

challenged claims of the ’499 patent.

5. Huebner

U.S. Patent No. 5,456,685 (“Huebner,” Ex. 1023) was filed on February 14,

1994 and is § 102(e) prior art to the ’499 patent. Huebner is directed to an

“orthopedic fixation screw” (Abstract) with a thread having an outer edge 39 that

increases in thickness toward the proximal end of the screw, such that every turn

“cuts a wider groove into wall 58 than the proceeding turn.” (3:61-63).

This proximally increasing thread thickness “further reduc[es] the possibility of

screw 12 coming loose.” (3:66-67).

- 17 -

E. Level of Ordinary Skill in the Art

A POSA related to the ’499 patent would have (a) at least a master’s degree

in mechanical engineering or equivalent, or a bachelor’s degree in such field and at

least two years of experience designing suture anchors; or (b) a medical degree and

at least two years of work performing surgeries that involve suture anchors and/or

advising engineers on suture anchor design. A POSA would be able to understand

and apply the prior art discussed herein. (Slocum ¶ 28; Sklar ¶ 36).

F. Statutory Grounds for Challenge

Petitioners request cancellation of claims 1-4 and 8-16 of the ’499 patent

based on the following grounds.

GROUND REFERENCE(S) CLAIMS BASIS

1 Schmieding 1-4, 8-16 § 102(b)

2A Rosenberg ’463 File 1, 4, 8, 11-13, 16 § 102(b)

2B Rosenberg ’463 File, Stone 1-4, 8-16 § 103(a)

3 Nazre 8-12, 14-16 § 103(a)

4 Nazre, Huebner 1-4, 13 § 103(a)

The grounds are not redundant of one another.

Ground 1 is based on Schmieding, which anticipates all challenged claims

and is prior art under the ’499 patent’s actual filing date of April 3, 2001. See infra

Section VII. However, Ground 1 would not apply under the purported (erroneous)

priority date of August 5, 1996.

- 18 -

Grounds 2A and 2B are based on Rosenberg ’463 File, which discloses all of

the Screw Features. Rosenberg anticipates many claims (per Ground 2A) while

rendering the remaining claims obvious in view of Stone, which discloses the

remaining Suture Anchor Features (per Ground 2B).

Unlike Grounds 2A and 2B, Grounds 3 through 4 do not require measuring

dimensions of prior art drawings to assess relative proportions of screw thread

diameters.2 Instead, Grounds 3 and 4 are based on Nazre coupled with a POSA’s

knowledge concerning the relationship between thread depth and a screw’s holding

power in bone, given the settled law that identifying preferred values for a result-

effective variable like the ratio of outer thread diameter to inner thread diameter is

presumptively obvious, absent evidence that the claimed values are critical and

yield properties different in kind—not degree—from the prior art. E.g., In re

Huang, 100 F.3d 135, 139 (Fed. Cir. 1996).

VI. CLAIM INTERPRETATION

In this proceeding, claim terms should be given their broadest reasonable

interpretation (“BRI”) consistent with the specification. 37 C.F.R. § 42.100(b).

That interpretation may be different from the proper construction in district court. 2 Grounds 2A and 2B rely on basic measurements, consistent with (1) controlling

law regarding design patent drawings and (2) Patent Owner’s own reliance on

relative proportions when prosecuting the ’162 patent. See supra Section V.C.1.

- 19 -

The Board need not provide complete constructions of all claim terms when

it is clear that the cited prior art satisfies a claim limitation under any reasonable

interpretation. Abbott Labs. v. Baxter Pharma. Prods., Inc., 471 F.3d 1363, 1368

(Fed. Cir. 2006) (holding it was unnecessary to construe a phrase “with numerical

exactitude,” as claims were anticipated under “any definition … that the claims

might reasonably bear”); EMI Grp. N. Am., Inc. v. Intel Corp., 157 F.3d 887, 895

(Fed. Cir. 1998) (“[I]t is irrelevant whether the district court achieved a

technologically perfect definition, because there is no dispute that the

corresponding step of the Intel process is within the literal scope of [limitation].”);

Volkswagen Grp. of Am., Inc. v. Signal IP, Inc., IPR2015-01088, 2015 WL

6690118 (PTAB Oct. 29, 2015) (“Only those terms which are in controversy need

to be construed, and only to the extent necessary to resolve the controversy.”).

A. Preambles (All Independent Claims)

Independent claims 1 and 8 include preambles reciting “[a] suture anchor for

securing suture to soft bone.” Independent claim 12 includes a preamble reciting

“[a] suture anchor for securing tissue to soft bone.”

These preambles do not limit the claim, as Patent Owner has acknowledged

in co-pending litigation. (Ex. 1041 at 1, 10, 19). Instead, the preambles merely

state an “intended use” for the claimed suture anchors and anchor assemblies.

Summit 6, LLC v. Samsung Elecs. Co., 802 F.3d 1283, 1292 (Fed. Cir. 2015).

- 20 -

Preambles are “[g]enerally… not limiting,” id., especially when the claim bodies

define a “structurally complete invention.” Am. Med. Sys., Inc. v. Biolitec, Inc.,

618 F.3d 1354 (Fed. Cir. 2010) (holding that preamble did not limit claims).

B. Outer and Inner Thread Diameter (All Independent Claims)

All challenged claims require that the suture anchor include a “central body”

with a “continuous thread disposed in a spiral around the central body.” The

thread’s outer diameter must be “at least twice” its inner diameter “along a portion

of the thread.”

Given the antecedent basis for “the thread,” this ratio necessarily involves

diameters taken along the “central body” rather than the “tip” portion, which the

’499 patent distinguishes from the central body. (Ex. 1002 at 3:56-58). The ’499

patent does not define a categorical way to distinguish between the “central body”

and the “tip,” but does disclose an embodiment in which a central body 4 and a tip

8 have different tapers. A POSA would have understood “central body” to refer, at

least, to a portion with one taper, separate from a pointed tip portion with a greater

taper. (Slocum ¶¶ 93-94).

The specification does not explain what constitutes a “portion” of the

“thread … around the central body” for identifying outer and inner diameters from

which to calculate the ratio. The inventors added “along a portion” for the first

time in the claims of the grandparent ’162 patent. See supra Section V.C.1.

- 21 -

Given that the central body tapers distally (as required by all of the claims)

and the inner diameter of the thread therefore decreases distally, a POSA would

appreciate that the longer the “portion” of thread one considers, the more likely it

is that the outer diameter at one end of the portion will be “at least twice” the inner

diameter at the other end of the portion. (Slocum ¶ 131).

Necessarily, the shortest “portion” of thread around such a central body

over which one could measure both an outer diameter and an inner diameter is a

portion that encompasses a half revolution of thread and a corresponding root

adjacent to the half revolution of thread. (Slocum ¶ 132).

- 22 -

Thus, the ratio limitation must at least cover a thread, around a “central

body” that is identifiable as described above,3 in which the diameter from crest to

crest in the half revolution (i.e., the “outer” or “major” diameter) is at least twice

the diameter of the adjacent root (i.e., the adjacent “inner” or “minor” diameter).

(Slocum ¶ 133). Because there can be no dispute that such a thread would fall

within the scope of the ratio limitation, it is referred to as the “Incontestable Claim

Scope.” (Slocum ¶ 134). Measuring the inner diameter adjacent to the outer

diameter is the standard approach in the prior art. See Slocum ¶¶ 132-34. This

interpretation is also consistent with the specification’s emphasis (reiterating the

prior art) that “increasing the ratio” serves to “provide an increased percentage of

thread surface area for each turn of the screw … thus providing increased pull-out

strength.” (Ex. 1002 at 2:28-32).

All three of the primary references relied upon in this Petition—Schmieding

(Ex. 1017), Rosenberg ’463 File (Ex. 1016), and Nazre (Ex. 1024)—anticipate or

render obvious a suture anchor satisfying “the outer diameter of the thread

[is/being] at least twice the inner diameter of the thread” requirement under the

Incontestable Claim Scope. See infra Section IX; Slocum ¶ 135. Therefore, the

Board need not consider the reach (if any) of this claim limitation beyond the

Incontestable Claim Scope. Abbott., 471 F.3d at 1368. 3 I.e., a portion with a taper, separate from a tip portion with a greater taper.

- 23 -

However, should the Board conclude that cancellation of the challenged

claims is inappropriate under the Incontestable Claim Scope, Petitioners request

that the Board consider a broader interpretation taken by Patent Owner in co-

pending litigation and adopted by an Examiner in the currently-pending appeal of

the ’067 application, which is a descendent of the ’499 patent. Under this broader

approach (“Patent Owner’s Proposed Claim Scope”), the “inner diameter” need not

be measured adjacent to the “outer diameter”:

Ex. 1041 at 8 (Excerpt from Patent Owner’s Infringement Contentions)

Ex. 1011 at 360 (Excerpt From Examiner’s Answer, Appeal No. 2013-008985)

However, Petitioners deny that Patent Owner’s Proposed Claim Scope would be

proper in district court.4 4 All of Petitioners’ claim constructions (including the Incontestable Claim Scope

for the outer-to-inner diameter ratio requirement) would be proper in district court.

- 24 -

VII. APPLICABLE PRIORITY DATE

Claims 1-4 and 8-16 of the ’499 patent are not entitled to priority based on

any application filed before the ’499 patent’s own April 3, 2001 filing. SAP Am.,

Inc. v. Arunachalam, IPR2014-00414, 2015 WL 4941753, *13 (PTAB Aug. 17,

2015) (holding that purported “divisional” application was only entitled to the

“actual filing date of the application that led to issuance” because “[i]n order to

rely on an earlier filing date, the subject matter for which the earlier filing date is

relied upon must be shown to be in the earlier disclosure.”).

The ’499 patent asserts priority through Serial Nos. 09/588,065, filed on

June 5, 2000 (Ex. 1007 at 5-20); 08/954,206, filed on Oct. 20, 1997 (Ex. 1017);

08/905,393, filed on Aug. 4, 1997 (Ex. 1005 at 4-20); and 60/023,011, filed on

Aug. 5, 1996 (Ex. 1004 at 5-21) (“the Alleged Priority Documents”).

For the ’499 patent claims to benefit from an earlier date, “each application

in the chain leading back to the earlier application must comply with the written

description requirement of 35 U.S.C. § 112.” Lockwood v. Am. Airlines, 107 F.3d

1565, 1572 (Fed. Cir. 1997); see also SAP, 2015 WL 4941753 at *13 (assessing

priority claim in IPR).

However, none of the Alleged Priority Documents permit a POSA to

“clearly conclude that the inventor invented the claimed invention as of the filing

date sought.” Lockwood, 107 F.3d at 1572.

- 25 -

The Alleged Priority Documents only disclose a thread diameter ratio of

“between 2.25 and 2.75” and never mention, as required by all of the ’499 patent

claims, an “outer diameter of the thread … at least twice the inner diameter of the

thread along a portion of the thread.” 5

To support that requirement, the Alleged Priority Documents would have to

support both the lower limit (“twice”) and the open-ended reach (“at least”). E.g.,

Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570 (Fed. Cir. 1985) (parent

application failed to support claims reciting moisture content of “at least about

20%”); In re Blaser, 556 F.2d 534, 538 (CCPA 1977) (denying priority for claim

requiring “water in said mixture being from 0.6 to 1.6 mols” because description

failed to support lower limit). The Alleged Priority Documents fail to support

either the lower limit or the open-ended upper limit. 5 A preliminary amendment file during prosecution of the parent ’065 application

(Ex. 1007 at 26-31) was not part of the original disclosure because it lacked an

accompanying inventor declaration. Ex parte George, 230 USPQ 575 (BPAI

1984); Ex Parte Deacon, Appeal 2003-1272, 2005 WL 4755435, *7 (BPAI June 2,

2005) (preliminary amendment not referenced in declaration “does not enjoy status

as part of the original disclosure”); MPEP § 714.01(e) (“For applications filed

before September 21, 2004,” status of preliminary amendment depends on whether

“amendment was referred to in the first executed oath or declaration”).

- 26 -

First, there is no disclosure that the inventors considered an outer diameter

“twice” the inner diameter to define the lower limit for their invention. E.g.,

Purdue Pharma L.P. v. Faudling Inc., 230 F.3d 1320, 1326-27 (Fed. Cir. 2000)

(affirming that specification failed to support claims because it did not direct a

“skilled artisan to the Cmax/C24 ratio or what value that ratio should exceed.”).

Instead, 2.0 is an “arbitrary value” that Patent Owner inserted after filing. Ex parte

Tosaka, Appeal 2008-3927, 2008 WL 5192432, *5 (BPAI Dec. 10, 2008).

As a matter of law, the Alleged Priority Documents’ disclosure of “between

2.25 and 2.75” fails to support “at least twice.” Eiselstein v. Frank, 52 F.3d 1035

(Fed. Cir. 1995) (“Since the grandparent application only disclosed a nickel range

of 45–55%, it can hardly be said to have disclosed 50–60%.”); Ex parte Scott,

Appeal 1997-1498, 2001 WL 863732, *2-3 (BPAI) (disclosures of 32%, 34%,

66%, and 100% did not support claims to “greater than about 30%”).

Nor do the Alleged Priority Documents permit a POSA to “derive” a ratio of

2.0 as a lower boundary of the invention. E.g., Eli Lilly & Co. v. L.A. Biomedical

Research Institute, IPR2014-00693, 2014 WL 5462679, *4-5 (PTAB Oct. 23,

2014) (holding that application failed to support dosage limitation of “up to 1.5

mg/kg/day”). If disclosing “between 2.25 and 2.75” could support 2.0, it could just

as easily support 1.9, or 1.8, or any other value outside the range.

- 27 -

Likewise, the closed-end preferred embodiment fails to support the open-

ended upper limit. E.g., In re Wertheim, 541 F.2d 257 (CCPA 1976) (claims

requiring “at least 35%” were not supported by a disclosure of 25-60%); Ex parte

Farnworth, Appeal 2006-2181, 2006 WL 2230047, *2 (BPAI) (ratios of 10:1 and

15:1 provided “absolutely no descriptive support for the broad claimed ranges of

‘at least 10:1’ and ‘at least 15:1,’ which have no upper limit”).

While the Alleged Priority Documents include a table from which one could

potentially derive certain specific ratios greater than 2.75:1, such isolated values

likewise fail to support the “recited open-ended ranges.” Ex parte Delaite, Appeal

2009-004953, 2010 WL 1607501, *2 (BPAI Apr. 19, 2010) (particular value in

table failed to support “recited open-ended ranges”).

Further, it is immaterial that the Alleged Priority Documents refer generally

to “increasing pull-out strength” by increasing the outer-to-inner diameter ratio.

This correlation—already known to a POSA—does nothing to indicate what the

inventors considered to be their invention, as distinguished from the prior art.

The predictability of the technology is also irrelevant. In re Blaser, 556 F.2d

at 538 (while deriving claim limitation would have been “simple … enablement

and obviousness are not the issues; description of the invention is.”).

For the above reasons, claims 1-4 and 8-16 of the ’499 patent are not entitled

to a priority date earlier than the April 3, 2001 filing date of the ’499 patent itself.

- 28 -

VIII. THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW

This Petition and the supporting evidence demonstrate “a reasonable

likelihood that petitioner would prevail” as “to at least one of the claims challenged

in the petition.” 35 U.S.C. § 314(a). Claims 1-4 and 8-16 are anticipated and/or

obvious over the prior art references relied upon in this Petition, as explained in

detail by Dr. Slocum (Ex. 1057), a Professor of Mechanical Engineering at MIT,

and Dr. Sklar (Ex. 1059), an orthopedic surgeon with suture anchor experience.

IX. CLAIM-BY-CLAIM EXPLANATION OF GROUNDS FOR

UNPATENTABILITY OF CLAIMS 1-4 AND 8-16

A. Ground 1: Schmieding Anticipates Claims 1-4 and 8-16

Schmieding (Ex. 1017) is described generally in Section V.D.1 above. As

shown in the claim charts below, Schmieding discloses every limitation of claims

1-4 and 8-16 under the BRI and therefore anticipates claims 1-4 and 8-16. Indeed,

Schmieding (i.e., the application corresponding to the ’162 patent, the grandparent

of the ’499 patent) is identical to the ’499 patent specification as filed.

There are only two minor differences between Schmieding (on which the

claim charts rely) and the ’499 specification as issued. First, Schmieding does not

include the two sentences discussing the Screw Feature of proximally increasing

thread thickness. Second, Schmieding describes the drive head as including “slots”

for suture rather than “channels” for suture. Patent Owner amended the ’499

patent during prosecution to make these changes. (Ex. 1008 at 41-42).

- 29 -

Patent Owner previously made these exact same changes when prosecuting

the ’162 patent (i.e., corresponding to Schimieding itself). The amendments are

implicit in Schmieding, as the Examiner necessarily determined when entering the

amendments rather than rejecting them as new matter under 35 U.S.C. § 132.

Increasing Thread Thickness. As explained in Section V.C.1 above, Patent

Owner represented that Figure 1 of Schmieding provides an “unambiguous

disclosure of a suture anchor in which the thickness of the outer edge of the thread

increases proximally along a portion of the thread. (Ex. 1006 at 64-65). A POSA

studying Figure 1 would reach the same conclusion. (Slocum ¶¶ 257-59; Sklar ¶

64). The Examiner then allowed amendment of the specification to refer to the

proximally increasing thread thickness illustrated in Figure 1.

Channels in the drive head. Schmieding teaches that “slots 14, also shown

in Fig. 2, are formed along either side of the drive head 10 to accommodate the

suture.” (Ex. 1017 at 7:2-3). Patent Owner later filed a preliminary amendment

changing “slots” to “channels.” (Ex. 1006 at 70). The terms are thus equivalent.

A POSA would understand a slot, defined as a “long, narrow opening” (Exs. 1037

& 1038), to constitute a channel. (Sklar ¶ 63; Slocum ¶ 221).

Sufficiency of Schmieding’s Disclosures for Anticipation, but not Priority.

As the application corresponding to the ’162 patent, Schmieding is one of

the Alleged Priority Documents that, as detailed in Section VII above, fail to

- 30 -

support the ’499 patent claims for failure to indicate that the inventors had

developed a suture anchor with a thread with an outer diameter “at least twice the

inner diameter along a portion of the thread.” Yet Schmieding does disclose

examples of anchors having ratios in the claimed range. (Ex. 1017 at 4:9-14).

Such examples anticipate the claims even though they do not establish priority

under § 112. In re Lukach, 442 F.2d at 969-70 (disclosure in grandparent

application of ratio of 2.6 failed to support claims to a range of ratios between 2.0-

3.0, but intervening published application anticipated the claims because it

disclosed the 2.6 ratio). Simply put, “differences exist between the requirements

for claim-anticipating disclosures and for claim-supporting disclosures.” Chester

v. Miller, 906 F.2d 1574, 1577 (Fed. Cir. 1990) (citing Lukach).

Per the claim charts below, Schmieding anticipates claims 1-4 and 8-16:

’499 PATENT CLAIM 1 SCHMIEDING (EX. 1017)

1[pr.] A suture anchor for securing suture to soft bone, comprising:

1:11-14 (“[T]he present invention relates to arthroscopic apparatus and methods for anchoring suture to cancellous bone using a suture anchor….”)

1[A1] a central body having a central axis, a distal end and a proximal end,

3:13-14 (“The…suture anchor has a central body, a distal end, and a proximal end.”)

1[A2] the central body tapering in diameter along a major portion thereof from a maximum diameter near the proximal end to a minimum diameter toward the distal end;

3:14-16 (“The central body preferably tapers from the proximal end to terminate in a point at the distal end.”)

- 31 -

1[B] a drive head formed on the proximal end of the central body;

3:21-23 (“The proximal end of the corkscrew suture anchor body has a hex drive head incorporating a slotted suture eye for receiving one or more pieces of suture.”)

1[C] an eyelet for receiving at least one strand of suture formed on the proximal end of the central body;

1[D] a tip formed on the distal end of the central body; and

3:14-16 (“The central body preferably tapers from the proximal end to terminate in a point at the distal end.”)

1[E1] a continuous thread disposed in a spiral around the central body, the thread having an outer edge having a thickness,

3:9-12 (“The suture anchor….ha[s] preferably a single thread spiraling helically around a central body.”); 6:23-26 (“Referring to Fig. 1, the suture anchor of the present invention includes a body….A continuous thread wrap around body 4 in a clockwise direction, as shown.”)

1[E2] the thickness of the outer edge of the thread increasing proximally along a portion of the thread;

See Figure 1; see also Ex. 1006 at 64 (“Applicants explained … that the relative thicknesses between the proximal and distal flights of the thread are shown unambiguously in Fig. 1….[T]he drawing…shows the thread flight thickness increasing proximally..”)

1[E3] wherein the continuous thread extends at least along the major portion of the central body; and

3:9-16 (“The suture anchor….ha[s] … a single thread spiraling helically around a central body….The central body … tapers from the proximal end to terminate in a point at the distal end.”)

1[E4] wherein the outer diameter of the thread is at least twice the inner diameter of the thread along a portion of the thread

4:9-14 (“The increase in the surface area… is achieved in part by increasing the ratio of the outer diameter of the threads to the inner diameter of the threads. Preferably, the ratio is between 2.25 and 2.75...”).

2. The suture anchor of claim 1, further comprising channels for suture on the drive head.

7:2-5 (“Slots 14, also shown in Fig. 2, are formed along either side of the drive head 10 to accommodate the suture ….”)

- 32 -

3. The suture anchor of claim 1, further comprising two lengths of suture attached to the suture anchor.

6:29-7:1 (“[S]uture eye 12 preferably is…an oval aperture in the drive head for holding … preferably two … pieces of … suture.”)

4. The suture anchor of claim 1, wherein the drive head is hexagonal.

6:27-28 (“Suture anchor 2 is provided…with hexagonal drive head 10.”)


See claim 1[pr.] above.

8[A] a central body having a central axis, a distal end and a proximal end,

See 1[A1] above.


See 1[A2] above.

8[B1] a tip portion formed on the distal end of the central body

7:6-7 (“Tip 18 terminates in ... point 20… approached by a … conically tapered surface 22 [which] features an angle of taper deeper than the taper of body 4.”)

8[B2] the tip portion having a conical shape and tapering from the minimum diameter to a point, the tip portion having a taper that is greater than the taper of the major portion of the central body; 8[C] a drive head formed on the proximal end of the central body;

See 1[B] above.

8[D] an eyelet for receiving at least one strand of suture formed on the proximal end of the central body; and

See 1[C] above.

8[E1] a continuous thread disposed in a spiral around the central body;

See 1[E1] above.


See 1[E3] above.

8[E3] wherein the outer diameter of the thread is at least twice the inner diameter of the thread along a portion of the thread.

See 1[E4] above.

- 33 -


See claim 2 above.


See claim 3 above.


See claim 4 above.

12[pr.] A suture anchor for securing tissue to soft bone, comprising:

See 1[pr] above.


See 1[A1] above.

12[A2] the central body tapering in diameter along a portion thereof from a maximum diameter near the proximal end to a minimum diameter in a direction toward the distal end;

See 1[A2] above.

12[B] a tip portion formed on the distal end of the central body, the tip portion terminating in a point;

See 5[D] above.

12[C] a drive head formed on the proximal end of the central body;

See 1[B] above.

12[D] an eyelet for receiving at least one strand of suture formed on the drive head; and

See 1[C] above.

12[E1] a continuous thread disposed in a spiral around the central body, said continuous thread extending at least along the tapered portion of the central body, said continuous thread having an inner diameter and an outer diameter;

See 1[E1] and [E3] above.

12[E2] wherein the outer diameter of the thread is at least twice the inner diameter along a portion of the thread.

See 1[E4] above.

13. The suture anchor of claim 12, wherein the continuous thread has a thickness, the thickness of the thread increasing proximally along a portion of the thread.

See 1[E2] above.

- 34 -


See claim 2 above.


See claim 3 above.


See claim 4 above.

B. Grounds 2A and 2B: Rosenberg ’463 File

Renders Claims 1-4 and 8-16 Unpatentable

Rosenberg ’463 File (Ex. 1016) is described in Section V.D.2. above.

Rosenberg discloses a suture anchor, also known as a suture anchor “peg” (Sklar

¶¶ 68-69) that is preferably used “temporarily” during ACL reconstruction. (Ex.

1016 at 15). This tracks the ’499 patent’s discussion of “procedures that require

removal or relocation of suture anchors.” (Ex. 1002 at 1:58-59). Rosenberg’s

anchor was also useful to secure soft tissue to bone. (Ex. 1024 at 1:9-58).

1. Rosenberg ’463 File Discloses All Screw Features

Rosenberg ’463 File’s drawings depict a suture anchor that satisfies all of

the Screw Features in claims 1-4 and 8-16 under the BRI. Design patent drawings

can invalidate utility claims. In re Aslanian, 590 F.2d 911, 914 (CCPA 1979)

(“[T]he specific disclosure of structure in a design patent application may

inherently teach functional features.”). Rosenberg’s drawings depict a central

body with a central axis, a distal end, and a proximal end:

- 35 -

(Slocum ¶¶ 90-91). A POSA would also understand the drawings to disclose that

substantially the entire central body is tapered, with a conical tip portion formed on

the central body and having a greater taper, leading to a point:

(Slocum ¶¶ 95-98). See also Ex Parte Stephenson, Appeal 2009-014158, 2011 WL

2693003, *2 (BPAI July 8, 2011) (“[W]e agree with the Examiner that Ogawa’s

drawings consistently show the openings to be tapered and thus may be used to

demonstrate the presence of a tapered opening.”); Ex Parte Lemay, Appeal 2008-

0786, 2008 WL 4371689, at *5 (BPAI Sept. 24, 2008) (“Figure 47…discloses and

suggests to a [POSA] that the leading end…tapers.”). Indeed, the two tapers

illustrated in Rosenberg mirror the ’499 patent’s depiction of the tip “having an

angle of taper deeper than the taper of body 4.” (Ex. 1002 at 3:59-60).

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In addition, a POSA would understand Figures 4 and 5 in Rosenberg ’463

File to depict a continuous thread disposed in a spiral around the central body, the

thread having an outer edge having a thickness:

(Slocum ¶ 107). Moreover, a POSA would understand from Figure 4 that the taper

and thread of the central body extend along substantially the entire central body (as

in the preferred embodiment illustrated in the ’499 patent specification), thus

constituting a “major portion” of the central body under any conceivable

definition. (Slocum ¶ 108). Accordingly, for purposes of this petition, “major

portion” need not be construed “with numerical exactitude.” Abbott, 471 F.3d at

1368.

Figure 4 also conveys that the thickness of the outer edge of the thread

increases toward the proximal end of the suture anchor’s central body:

- 37 -

(Slocum ¶ 109). Moreover, Rosenberg ’463 File expressly discloses that the “first

few thread courses on the peg are relatively sharp in order to help screw the peg

into the bone and retain it in place,” while the “remaining courses of threads are

flat or rounded” to avoid damaging tissue. (Ex. 1016 at 16).

Finally, a POSA would understand from Figure 4 that the outer diameter of

the thread is at least twice the inner diameter along a portion of the thread under

the Incontestable Claim Scope and under the broader Patent Owner’s Proposed

Claim Scope. See supra Section VI.B. These proportions are readily evident:

Incontestable Claim Scope

Patent Owner’s Proposed Claim Scope

(Slocum ¶¶ 141-43). See, e.g., In re Mraz, 455 F.2d 1069, 1072 (CCPA 1972)

(relying on drawings depicting a feature “well within the range recited in” claims);

Ex parte Hoang, Appeal 2013-007488, 2015 WL 4940443, at *4-6 (PTAB Aug.

17, 2015) (affirming anticipation rejection because “radius of curvature that is at

least five times the respective diameter” was “readily evident” in figure); Ex parte

Sato, 2014 WL 1154010, at *2-3 (PTAB Mar. 20, 2014) (determining that

drawings had sufficient detail “for showing generalized proportions”); Ex parte

Mauler, Appeal 2012-008098, 2013 WL 4397015, at *2 (PTAB Aug. 14, 2013)

- 38 -

(holding that drawing suggested “an L/W ratio within the claimed range of ‘at least

2:1’” even though reference did not “explicitly describe any length, width, or L/W

ratio”); Ex parte Denis, Appeal 2011-011705, 2013 WL 5400168, at *3 (PTAB

Jan. 22, 2013) (affirming rejection: “[I]t would appear that the relative dimension

[in the prior art reference] would have yielded at least a 1:3 ratio.”); Ex parte

Wang, Appeal 2009-005165, 2009 WL 3497077, *5-6 (BPAI Oct. 28, 2009)

(affirming anticipation rejection because figure in prior art reference depicted “an

aspect ratio greater than one”).

Further, a POSA would have studied the specific outer and inner diameters

illustrated in Rosenberg ’463 File given the known link between outer-to-inner

diameter ratio and pullout strength. (Slocum ¶ 145; Ex. 1032 at 173).

A POSA would also have carefully considered the drawing proportions for

the separate reason that they are part of the design patent’s ornamental

characteristics. Lee v. Dayton-Hudson, 838 F.2d 1186, 1188 (Fed. Cir. 1988)

(“[T]he district court correctly viewed the…proportions …and all other ornamental

characteristics, considered to the extent that they would be considered by ‘the eye

of an ordinary observer.’”); ATAS Int’l v. Centria, IPR2013-00259, slip op. at 8

(Sept. 24, 2013) (“[T]o the extent that proportions and shape of a design contribute

to the overall visual effect, they must be taken into consideration.”)

- 39 -

Moreover, design patent drawings must provide “a complete disclosure of

the appearance of the design.” 37 C.F.R. § 1.152. The Patent Office stresses that:

The necessity for good drawings in a design patent application cannot

be overemphasized. As the drawing constitutes the whole disclosure

of the design, it is of utmost importance that it be so well executed

both as to clarity of showing and completeness that nothing regarding

the design sought to be patented is left to conjecture.

MPEP § 1503.02. Given these standards—in place when the Rosenberg ’463 File

application was filed (Ex. 1064)—a POSA would have relied on the relative outer

and inner thread diameter dimensions therein. (Slocum ¶ 141).

2. Ground 2A: Rosenberg ’463 File Anticipates Claims 1, 4, 8, 11, 12, 13, and 16

Rosenberg ’463 File anticipates Claims 1, 4, 8, 11, 12, 13, and 16.

a. Claims 1, 8, and 12

Independent claims 1, 8, and 12 largely recite particular Screw Features, all

of which Rosenberg discloses for the reasons explained in Section IX.B.1 above.

The only other limitations concern the positioning of the drive head and the

associated eyelet. Rosenberg ’463 File discloses these Suture Anchor Features.

Figure 4 illustrates a drive head “formed on the proximal end of the central body”

(as required by claims 1, 8, and 12). (Sklar ¶ 157; Slocum ¶ 191). Indeed, Figure 4

of Rosenberg is identical to Figure 1 of the ’499 patent in relevant respect; both

illustrate a drive head formed directly on a threaded central body.

- 40 -

Figure 4 also illustrates an eyelet “formed on the proximal end of the central

body” (as required by independent claims 1 and 8). (Sklar ¶ 163; Slocum ¶¶ 192-

93). The eyelet is incorporated directly into the drive head, which is at the

proximal end of the central body.

(Sklar ¶¶ 163, 169-172; Slocum ¶ 193). The result would be the same even if one

interpreted the tab containing the eyelet as separate from the drive head. AFG

Inds. V. Cardinal IG Co., 239 F.3d 1239, 1251 (Fed. Cir. 2001) (holding that

“formed on” allowed for “interlayers between layers” and was not limited to

“directly in contact with”); Ex parte Woo, Appeal 2012-004629, 2014 WL

5511419, at *6 (PTAB Oct. 30, 2014) (“‘Formed on, by itself, does not denote

‘formed directly on.’”). Indeed, the ’499 patent refers generically to the eye[let]

being “at” or “on” the “proximal end of the suture anchor.” (Abstract; 3:14-15).

There is no suggestion that the exact placement was material to the invention.

For these same reasons, the eyelet is “formed on the drive head” (as required

by claim 12). (Sklar ¶¶ 180-181; Slocum ¶ 195). The minor variance in language

relative to claims 1 and 8 is immaterial. E.g., Hormone Research Foundation, Inc.

- 41 -

v. Genentech, Inc., 904 F.2d 1558, 1567 n.15 (Fed. Cir. 1990) (“It is not unusual

that separate claims may define the invention using different terminology,

especially where (as here) independent claims are involved.”)

These and other disclosures in Rosenberg ’463 File are summarized below.

’499 PATENT CLAIM 1 ROSENBERG ’463 FILE (EX. 1016) 1[pr.] A suture anchor for securing suture to soft bone, comprising:

p. 15 (“The claimed design invention is a ‘peg’ used in medical surgery to attach a suture to a bone or tissue….”).


p. 33 (showing Fig. 4).



1[B] a drive head formed on the proximal end of the central body;

p. 33 (showing Fig. 4); p. 15(“[A] suture attached to the eyelet at the rear end of the key is used with an isometer to test the graft location”).

1[C] an eyelet for receiving at least one strand of suture formed on the proximal end of the central body; 1[D] a tip formed on the distal end of the central body; and


1[E1] a continuous thread disposed in a spiral around the central body, the thread having an outer edge having a thickness,

p. 16 (“The first few thread courses on the peg are relatively sharp in order to help screw the peg into the bone and retain it in place. The remaining courses of threads are flat or rounded so that they will not cause damage to the posterior cruciate ligament or other parts in the knee joint.”); p. 33 (showing Figs. 4 and 5).

1[E2] the thickness of the outer edge of the thread increasing proximally along a portion of the thread; 1[E3] wherein the continuous thread extends at least along the major portion of the central body; and

- 42 -

1[E4] wherein the outer diameter of the thread is at least twice the inner diameter of the thread along a portion of the thread



See claim 1[pr.] above.

8[A] a central body having a central axis, a distal end and a proximal end,

See 1[A1] above.


See 1[A2] above.


See 1[D] above.

8[B2] the tip portion having a conical shape and tapering from the minimum diameter to a point, the tip portion having a taper that is greater than the taper of the major portion of the central body;

p. 33 (showing Fig. 4,); p. 5 (“FIGURE 1 is a perspective view of a Suture Anchor Peg....”).


See 1[B] above.


See 1[C] above.


See 1[E1] above.


See 1[E3] above.


See 1[E4] above.


See Section VI.A above.


See 1[A1] above.

- 43 -


See 1[A2] above.


See 8[B1] and [B2] above.


See 1[B] above.


See 1[C] above.


See 1[E1] and [E3] above.


See 1[E4] above.

For these reasons, independent claims 1, 8, and 12 are unpatentable because the

claimed subject matter was anticipated by Rosenberg ’463 File.

b. Claim 13

Claim 13 depends from claim 12 and requires proximally increasing thread

thickness. Rosenberg discloses proximally increasing thread thickness as detailed

in Section IX.B.2.a. In fact, claim 13 is broader than claim 1 with respect to this

limitation, and does not require that thickness increase along the “outer edge” of

the thread. Claim13 is unpatentable because the claimed subject matter was

anticipated by Rosenberg ’463 File.

- 44 -

c. Claims 4, 11, and 16

Claims 4, 11, and 16 depend from claims 1, 8, and 12, requiring that the

drive head be “hexagonal.” A POSA would understand Figure 3 in Rosenberg to

disclose a hexagonal drive head. (Slocum ¶ 205; Sklar ¶ 196-98). For these

reasons and those detailed in Section IX.B.2.a, claims 4, 11, and 16 are

unpatentable because the claimed subject matter was anticipated by Rosenberg

’463 File.

3. Ground 2B: Rosenberg ’463 File in View of Stone Renders Claims 1-4 and 8-16 Obvious

Stone is described generally in Section V.D.3 above. Rosenberg ’463 File in

view of Stone renders claims 1-4 and 8-16 invalid as obvious.

a. Claims 1, 4, 8, 11-13, and 16

Rosenberg ’463 File anticipates claims 1, 4, 8, 11-13, and 16 for the reasons

explained in Section IX.B.2 (Ground 2A), based on the plain meaning, under the

BRI standard, of the claim limitations concerning the position of the eyelet.

Further, Claims 1, 4, 8, 11-13, and 16 would be unpatentable even if the

claim limitations concerning the position of the eyelet were construed to be limited

to the ’499 patent’s preferred embodiment of an eyelet placed directly in the center

of a drive head that is formed directly on the proximal end of the central body, as

illustrated in Figure 1. See 3:49-51 (“The suture eye 12 preferably is in the form of

an oval aperture in the drive head.”)

- 45 -

Stone and Goble make clear that there is nothing inventive about the drive

head and eyelet placement in the ’499 patent’s preferred embodiment. For

example, Figure 10A in Stone and Figure 1 in Goble disclose the very same

configuration shown in Figure 1 of the ’499 patent. See supra Section V.D.3.

Consistent with Figure 10A, Stone teaches that both the “eyelet” and the drive

head (i.e., “suture/drive portion”) are each positioned at the same “end” of the

suture anchor, adjacent the central body. (Ex. 1022 at 2:17-22).

Likewise, Goble describes the eyelet (i.e., “bore 36”) as being “centered

on…sides 28 of the connector portion 14,” adjacent the central body (i.e., head

portion 12). (Ex. 1013 at 4:37-40, 5:26-30). These disclosures necessarily teach

“an eyelet…formed on the proximal end of the central body” (as required by

claims 1 and 8) and “an eyelet…formed on the drive head” (as required by claim

12). (Sklar ¶¶ 173, 180-182; Slocum ¶ 190).

Moreover, a POSA would have had reason to modify the suture anchor

disclosed in Rosenberg ’463 File to mirror Stone’s eyelet configuration. It was

known that Rosenberg’s “extending tab” (containing the eyelet) worked well in

certain scenarios, but could “be overly weak and break under tension” in other

situations (e.g., “in very small anchors and especially where delicate materials are

used”). It was also known that the tab required driving the anchor “more deeply

into the bone than a suture anchor without such a tab.” (Ex. 1024 at 1:57-2:27).

- 46 -

For these reasons, a POSA would have had reason to eliminate the extending tab

and select an alternative location for the eyelet. Stone’s disclosure of an eyelet

contained in the center of the drive head was one such alternative and would have

been a natural choice given that it was widely known elsewhere in the prior art,

including in Goble. (Sklar ¶¶ 173-177).

Thus, even under a narrow construction of the claim limitations concerning

eyelet position, claims 1, 4, 8, 11-13, and 16 would have been obvious over

Rosenberg ’463 File in view of Stone.

b. Claims 2, 9, and 14

Claims 2, 9, and 14 depend from the independent claims (addressed in

Section IX.B.3.a) and require “channels” on the drive head. Rosenberg ’463 File

discloses a drive head (shown in Figure 3) and teaches that the suture anchor

(“with a suture attached to the eyelet at the rear”) is screwed “by a hand-held driver

instrument.” (Ex. 1016 at 15). Incorporating channels into the drive head of a

suture anchor was a well-known technique to keep the suture from interfering with

the driver and the drive head. (Ex. 1013 at 2:64-3:3 (suggesting use of

“channels…adapted to receive…suture…so that the suture will not interfere with

the connector portion”); Ex. 1024 at 4:15-21 (describing use of “groove” in drive

head to align with groove in cannulated driver and “form an enclosed passageway

for conducting the suture…when the [driver] engages the driven portion”)).

- 47 -

Stone discloses drive heads with such channels, which are formed as a “pair

of grooves.” (Ex. 1022 at 2:55-62; Sklar ¶ 221). Indeed, Figure 10A in Stone

(discussed above) features the same configuration disclosed in Figure 1 of the ’499

patent. See supra Section V.D.3; Sklar ¶ 222.

Given (1) Rosenberg ’463 File’s disclosure of securing the suture anchor

using a “driver” and (2) the recognized design need to prevent sutures from

interfering with the driver, a POSA would have had reason to modify Rosenberg

’463 File based on Stone. In particular, a POSA would have had reason to

substitute Stone’s integrated drive head and eyelet design (including the associated

channels) in place of the configuration disclosed in Figure 4 of Rosenberg ’463

File. (Sklar ¶ 225). Moreover, a POSA would have had a reasonable expectation

of success given that including suture channels in the drive head was a known

design choice for improving engagement with the driver. (Id.).

Separately, a POSA modifying Rosenberg to replicate the eyelet position

taught in Stone and other prior art for the reasons discussed in Section IX.B.3.a

would have had reason to incorporate all of Stone’s drive head, including the

channels. (Sklar ¶ 226). Stone’s drive head design was documented elsewhere

(e.g., Ex. 1013 at Fig. 1; see also Section V.D.3), and a POSA would have desired

a well-known design to maximize acceptance. (Sklar ¶ 226).

- 48 -


eyelet position, claims 2, 9, and 14 would have been obvious over Rosenberg ’463

File in view of Stone.

c. Claims 3, 10, and 15

Claims 3, 10, and 15 depend from the independent claims (addressed in

Section IX.B.3.a) and require “two lengths” of suture attached to the suture anchor.

Stone discloses the benefits of “multiple suture fixation” to attach soft tissue to

bone. (Ex. 1022 at 2:10). Further, it was known that the anchor disclosed in

Rosenberg ’463 File could be used to attach soft tissue to bone. (Sklar ¶¶ 70-71;

Ex. 1024 at 1:9-58). Given the known need for multiple suture fixation, a POSA

would have had reason to pass two lengths of suture through the suture eyelet of

Rosenberg ’463 File’s anchor. A POSA would have had a reasonable expectation

of success given the predictability of the field and the success reported by Stone.

(Sklar ¶¶ 236-237, 240).

During prosecution of the ’102 continuation application (see supra Section

II.B), the Examiner rejected analogous claims because using two sutures “would

have been an obvious design choice.” (Ex. 1012 at 137-38, 141). Patent Owner

did not dispute this finding in response (id. at 156-164) or on appeal (id. at 178-

188).

- 49 -

Moreover, a POSA would have appreciated that Rosenberg’s eyelet could

accommodate multiple sutures or, alternatively, could be readily modified to

incorporate multiple sutures as taught in Stone. (Sklar ¶ 240).


eyelet position, claims 2, 9, and 14 would have been obvious over Rosenberg ’463

File in view of Stone.

C. Ground 3: Nazre in View of a POSA’s Knowledge

Renders Claims 8-12 and 14-16 Obvious

Nazre, described in Section V.D.4, expressly discloses all Screw Features of

claims 8-12 and 14-16 other than the numerical requirement that the outer thread

diameter of the thread be “at least twice the inner diameter” along a “portion of the

thread.” Nazre does not quantify actual thread diameters, but emphasizes that

“increas[ing] the positive engagement of the threads into the bone…increase[s]

attachment strength.” (Ex. 1024 at 2:35-43). A POSA would naturally have

selected the claimed 2:1 ratio, as increasing a screw’s outer-to-inner diameter ratio

was known to increase the screw’s holding power (e.g., Ex. 1032 at 173).

Nazre also discloses all Suture Anchor Features of claims 8-12 and 14-16

other than those of dependent claims 10 and 15. Claims 10 and 15 require “two

lengths of suture” connected to the anchor. Using two lengths of suture was an

“obvious design choice” when implementing Nazre—a fact that the Examiner

emphasized and Patent Owner does not dispute in the pending ’102 continuation.

- 50 -

1. Independent Claims 8 and 12

Screw Features. Nazre (Ex. 1024) describes a central body (i.e., the “shaft

2”) having a central (“longitudinal”) axis, a “proximal end 3,” and a “distal end 4.”

(3:12-14). A “continuous” “screw thread…spirals around” the central body “from

the proximal end 3 to the distal end 4.” (3:14-18). The central body “tapers…from

a larger diameter near the proximal end 3 to a smaller diameter near the distal end

4.” (3:39-41). The taper and thread extend along substantially the entire central

body (as in the ’499 patent’s preferred embodiment), thus satisfying claim 8’s

requirement that the taper and thread extend along at least a “major portion” of the

central body. Accordingly, “major portion” need not be construed in this

proceeding with numerical exactitude.” Abbott, 471 F.3d at 1368.

Nazre also discloses a tip portion at the distal end having a conical shape and

tapering from the minimum diameter to a point, with the tip portion having a taper

greater than the taper of the central body. A POSA would immediately understand

this from Nazre’s figures, which mirror the ’499 patent’s illustration of the tip

having “an angle of taper deeper than the taper of body 4.” (3:59-60).

- 51 -

(Slocum ¶¶ 100, 102). Indeed, during prosecution of the ’102 continuation

application (see Section II.B), the Examiner determined, and Patent Owner did not

dispute, that Figure 4 in Nazre discloses a distal tip portion with a taper “more

pronounced than the taper of the central body.” (Ex. 1012 at 69).

Nazre does not expressly disclose the outer and inner diameters of the thread

However, Nazre describes a suture anchor central body with a constant outer

thread diameter and a tapered central core, such that the inner diameter decreases

toward the distal end. (3:57). This “increase[s] the purchase of the threads distally

to increase the positive engagement of the threads into the bone distally to increase

attachment strength.” (3:58-59). This teaching tracks Nazre’s figures, which a

POSA would immediately understand to disclose a substantial thread depth toward

the distal end of the central body. (Slocum ¶ 147). These visual disclosures cannot

be “disregarded.” In re Mraz, 455 F.2d 1069, 1072 (CCPA 1972).

The ratio of outer to inner thread diameter was a recognized “thread

parameter,” with higher ratios known to correlate with higher pullout strength.

(Ex. 1032 at 173; Ex. 1046 at 465; Slocum ¶¶ 148-54). Increasing thread depth

distributes pullout forces more widely and increases the “density” of cancellous

bone, thus improving “its holding strength.” (Ex.1036 at 1304; Slocum ¶¶ 60-61,

79). This relationship underlies Nazre’s own teaching that greater thread depth

increased “purchase” and improved “attachment strength.” (Slocum ¶¶ 147-48).

- 52 -

Given this knowledge, a POSA implementing Nazre would selected the

claimed thread diameter ratio in the routine course of “optimization.” (Slocum ¶¶

158-62; Sklar ¶¶ 122-125). See also In re Huang, 100 F.3d at139 (affirming

rejection because a POSA “would have experimented with various thicknesses to

obtain an optimum range”). Indeed, ratios of 2.0 or greater were known in the

prior art and known as “cancellous threads.” (Ex. 1034 at 34-35; Ex. 1052 at 3:18-

21; Slocum ¶¶ 80, 150-53; Sklar ¶ 119-121). In re Aller, 220 F.2d 454, 456

(CCPA 1955) (if “general conditions” are known, “it is not inventive to discover

the optimum or workable ranges by routine experimentation”).

It was also known that screws having a tapered central core and an outer-to-

inner diameter ratio of between 2.0 and 3.0 exhibited excellent holding strength in

foam plastic blocks. (Ex. 1027 at 5:34-44; Slocum ¶¶ 71, 163-69). This teaching

would have commended itself to a POSA implementing Nazre, as foam was an

established proxy for cancellous bone when testing suture anchors and other

implantable devices. (Slocum ¶ 64; Sklar ¶ 52, 126-128).

There is no evidence to suggest anything critical about a ratio of 2.0 or

greater (i.e., the outer diameter being “at least twice the inner diameter”). Per

Section VII, the Alleged Priority Documents fail even to convey that the inventors

appreciated a ratio of 2.0 (as opposed to ratios between 2.25-2.75, which are not

reflected in the claims) as part of the invention, as distinguished from the prior art.

- 53 -

There is also no evidence that selecting a ratio of 2.0 or greater yielded a

“new and unexpected result which is different in kind and not merely in degree

from the results of the prior art.” In re Huang, 100 F.3d at 139 (quoting Aller and

holding that a POSA “would have experimented with various thicknesses to obtain

an optimum range”). Under these circumstances, a ratio of 2.0 is obvious. Id. See

also K-Swiss Inc. v. Glide N Lock GmnH, 567 Fed. App’x 906, 913-914 (Fed. Cir.

2014) (reversing Board and holding that claims to “percentages” were obvious).

The ’499 patent provides no data comparing the purported invention to the

prior art. The provisional application includes two charts (Ex. 1004 at 20-21), but

does not associate any of the prior art suture anchors with particular outer-to-inner

diameter ratios. Moreover, the charts rely on a 1995 article but misleadingly omit

multiple prior art anchors in that article that had demonstrated greater pull-out

strength than the purported commercial embodiments of the invention. (Sklar ¶¶

133-139; Slocum ¶¶ 177-79). For example, the charts omit the prior art anchor

found in the article to have the highest pullout strength in cancellous bone—more

than twice the strength reported of Patent Owner’s commercial embodiment. (Ex.

1029 at 25; see also Sklar ¶¶ 133-135). In short, there is nothing in the ’499 patent

suggesting that a ratio of “2.0 or greater” is non-obvious.

For these reasons, Nazre renders obvious a screw-based suture anchor

featuring all of the Screw Features of claims 8-12 and 14-16, including an outer

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thread diameter of “at least twice the inner diameter of the thread along a portion

of the thread,” consistent with the Indisputable Claim Scope (see Section VI.B).

Suture Anchor Features. Nazre discloses a drive head (“driven portion 7”)

that is “formed on” the proximal end of the central body, per independent claims 8

and 12. (Ex. 1024 at 3:15-22; Sklar ¶¶ 75, 158; Slocum ¶ 198).

Nazre also discloses that the eyelet is “near the proximal end” of the central

body (i.e., “shaft”) (2:19-22), such that a POSA would understand the eyelet to be

“formed on the proximal end of the central body” and “formed on the drive head”

per the plain meaning of these phrases in independent claims 8 and 12. (Sklar ¶

178; Slocum ¶ 199). See also AFG Indus., 239 F.3d at 1251 (“formed on” not

limited to “directly in contact with”).

Even if the Board interpreted the “formed on” phrases as limited to the

preferred embodiment shown in Figure 1 of the ’499 patent, a POSA would have

had reason to modify Nazre and construct a suture anchor with an eyelet “formed

on the proximal end of the central body” and “formed on the drive head” within

this construction. The eyelet and drive head configuration of ’499 patent Figure

1was known in the prior art, including in Stone (Ex. 1022) and Goble (Ex. 1013).

See supra Section V.D.3. A POSA would have had reason to adopt this

configuration to satisfy physicians familiar with the prior art designs. (Sklar ¶¶

179-182, 186-189). A POSA would also have had reason to adopt the

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configuration to reduce manufacturing costs and facilitate the use of deeper

threads, as disclosed in Goble. (Ex. 1013 at 2:18-20, 4:58-5:8; Slocum ¶¶ 200-01).

These and other disclosures in Nazre are summarized below. For these

reasons, claims 8 and 12 are unpatentable because they would have been obvious

over Nazre in view of the knowledge of a POSA.

’499 PATENT CLAIM 8 NAZRE (EX. 1024) 8[pr.] A suture anchor for securing suture to soft bone, comprising:

E.g., 1:5-7 (“The present invention relates generally to anchors for securing sutures to bone….”); see also Section VI.A above.


E.g., 3:11-13 (“Referring to FIGS. 1-7, a suture anchor 1 includes a shaft 2 having a longitudinal axis and a proximal end 3 and a distal end 4.”)


E.g., 2:35-38 (“The strength of the suture anchor and the attachment of the suture anchor to the bone are further optimized by tapering the shaft from a larger diameter proximally to a smaller diameter distally.”); 3:39-41.


Figures 1 and 3-4.

8[B2] the tip portion having a conical shape and tapering from the minimum diameter to a point, the tip portion having a taper that is greater than the taper of the major portion of the central body;

Figures 1 and 3-4.


E.g., 2:44-46 (“driven portion adjacent the proximal end”); 3:18-22 (“A driven portion 7 is formed near the proximal end 3….”)

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E.g., 2:20-22 (“A cross-hole is formed through the shaft and the screw thread near the proximal end.”)


E.g., 2:19-20 (“A screw thread extends from the shaft and spirals from the proximal to the distal end.”); 3:35-38.



See discussion above; see also 3:58-61 (“Maintaining a constant major diameter S while tapering the shaft distally, increases the purchase or depth of engagement toward the distal end….”); Figs. 1 & 3-4.


See 8[pr].


See 8[A1] above.


See 8[A2].


Figures 1 and 3-4.


See 8[C]


See 8[D]


See 8[E1-E2].


See 8[E3].

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2. Dependent Claims 9-11 and 14-16

Claims 9 and 14 depend from claims 8 and 12 and require “channels for

suture on the drive head.” Nazre discloses such channels in the form of “grooves”

(12, as shown in Figures 5 and 6), for “conducting suture as the suture traverses the

[drive head].” (Ex. 1024 at 2:48-55; Slocum ¶ 209; Sklar ¶ 75-77, 213-214).

Claims 11 and 16 depend from claims 8 and 12 and require a “hexagonal”

drive head. Nazre discloses a hexagonal drive head. (3:26; Slocum ¶ 207).

Claims 10 and 15 depend from claims 8 and 12 and require “two lengths of

suture attached to the suture anchor.” It was known that “multiple suture fixation”

was desirable because “multiple sutures are often required for soft tissue repair.”

(Ex. 1022 at 2:5-10). Thus, a POSA would have had reason to attach two or more

strands of suture when using Nazre’s suture anchor. (Sklar ¶ 239). Indeed, during

prosecution of the ’102 continuation (see supra Section II.B), the Examiner

rejected analogous claims as obvious over Nazre because “it would have been an

obvious design choice…at the time of the invention to attach two sutures to the

suture anchor instead of one.” (Ex. 1012 at 137-38, 141). Patent Owner did not

dispute this finding in response or on appeal.

For these reasons, dependent claims 9-11 and 14-16 are unpatentable

because they would have been obvious to a POSA, at the time of the invention,

over Nazre in view of the POSA’s knowledge.

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D. Ground 4: Nazre in View of Huebner and the

Knowledge of a POSA Renders Claims 1-4 and 13 Obvious

Independent claim 1 and related dependent claims 2-4 are essentially

identical to independent claim 12 and dependent claims 14-16 aside from requiring

proximally increasing thread thickness (i.e., the thickness of the outer edge of the

thread increasing proximally along a portion of the thread”) rather than a tip

portion having a separate taper. As explained in Section IX.C (concerning Ground

3), claims 12 and 14-16 are unpatentable because the claimed subject matter would

have been obvious over Nazre in view of the knowledge of a POSA.

Claim 13 depends from claim 12 and, like claims 1-4, also requires

proximally increasing thread thickness, although it is broader than claim 1 in the

sense of referring generally to the “thickness of the thread” –not the “thickness of

the outer edge.”

Nazre does not disclose proximally increasing thread thickness. However,

Huebner (described in Section V.D.5 above) discloses an “orthopedic fixation

screw” (designed to hold a ligament in a bone hole) with a thread having an outer

edge with a thickness that increases toward the proximal end of the screw. In

particular, “outer surface 39 increases in width toward the back of screw 12,” such

that “[e]ach turn of crest 38 cuts a wider groove into wall 58 than the proceeding

turn,” thus ensuring that each turn of the thread is “held firmly” in the bone mass,

“reducing the possibility of screw 12 coming loose.” (Ex. 1023 at 3:61-67).

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Nazre and Huebner are from the same field of endeavor in that both

references describe screws for use in orthopedic surgery and in particular for

securing soft tissue (e.g., ligaments) to bone. (Ex. 1024 at 1:5-13; Ex. 1023 at 1:7-

10; Sklar ¶ 150). Huebner also qualifies as relevant prior art for the separate

reason that it is reasonably pertinent to the problem of developing suture anchors

that had high pullout strength. As detailed in Section V.A, pullout strength was

widely used as a metric to compare various commercially available suture anchors.

To this end, Nazre discloses a thread design to improve “strength and bone

engagement.” (Ex. 1024 at 3:61-65). Huebner would have logically commended

itself to this problem given Huebner’s teaching that proximally increasing thread

thickness improves the purchase of the screw in bone. (Ex. 1023 at 3:61-67).

Given the recognized goal to maximize pullout strength, a POSA would

have had reason to modify the suture anchor disclosed in Nazre by increasing the

depth of the threads (as detailed in Section IX.C) and also by increasing the

thickness of the outer edge of the thread toward the proximal end, as taught in

Huebner. A POSA would have appreciated that increasing outer edge thread

thickness toward the proximal end of Nazre’s screw would serve the same function

reported for this thread characteristic in Huebner: ensuring that each successive

crest “cuts a wider groove” into bone, “reducing the possibility” of the screw

“coming loose.” (Ex. 1023 at 3:61-67; Slocum ¶ 121; Sklar ¶ 151).

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Moreover, a POSA would have had a reasonable expectation that modifying

Nazre in view of Huebner would be successful given Huebner’s teaching as well as

other disclosures in the prior art teaching the relationship between proximally

increasing thread thickness and greater pullout strength in bone and analogous

materials. (Ex. 1020 at 5:9-21; Ex. 1054 at 5:66-6:31; Slocum ¶ 122; Sklar ¶¶ 147,

152). The resultant suture anchor would embody all of the Screw Features and all

of the Suture Anchor Features. (Slocum ¶¶ 158, 460).

For these reasons and the corresponding discussion in Section IX.C, claims

1-4 and 13 are unpatentable because the subject matter would have been obvious to

a POSA at the time of the invention over Nazre in view of Huebner and the

knowledge of a POSA. (Slocum ¶¶ 457-60).

X. CONCLUSION

Inter partes review of claims 1-4 and 8-16 of the ’499 patent is requested.

Respectfully submitted, Smith & Nephew, Inc. and ArthroCare Corp.

Dated: January 22, 2016

By: __________________________ Michael N. Rader, Reg. No. 52,146 Jason M. Honeyman, Reg. No. 31,624 Richard F. Giunta, Reg. No. 36,149 Jennifer J. Wang, Reg. No. 68,598 WOLF GREENFIELD & SACKS, P.C. 600 Atlantic Ave. Boston, MA 02210-2206 Tel: 617-646-8000 / Fax: 617-646-8646

CERTIFICATE OF SERVICE UNDER 37 C.F.R. § 42.6(e)(4)

I certify that on January 22, 2016, I will cause a copy of the foregoing

document, including any exhibits or appendices referred to therein, to be served via

Express Mail upon the attorney of record for the patent at the following address:

DICKSTEIN SHAPIRO LLP 1825 EYE STREET NW

WASHINGTON DC 20006-5403

Date: January 22, 2016 /s/ Michael N. Rader Michael N. Rader, Reg. No. 52,146