Filed: February 28, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
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`SMITH & NEPHEW, INC.,
`Petitioner,
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`v.
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`CONFORMIS, INC.,
`Patent Owner.
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`Case No. TBD
`U.S. Patent No. 8,657,827
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`PETITION FOR INTER PARTES REVIEW
`OF CLAIMS 1-25, 28, 29, AND 32-46 OF U.S. PATENT NO. 8,657,827
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`By:
`
`Filed on behalf of:
`Smith & Nephew, Inc.
`Joseph R. Re
`Christy G. Lea
`Colin B. Heideman
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`Email: BoxSMNPHL.168LP6@knobbe.com
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`SMITH & NEPHEW, INC.,
`Petitioner,
`
`v.
`
`CONFORMIS, INC.,
`Patent Owner.
`
`
`
`
`
`
`
`
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`Case No. TBD
`U.S. Patent No. 8,657,827
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`PETITION FOR INTER PARTES REVIEW
`OF CLAIMS 1-25, 28, 29, AND 32-46 OF U.S. PATENT NO. 8,657,827
`
`
`
`By:
`
`Filed on behalf of:
`Smith & Nephew, Inc.
`Joseph R. Re
`Christy G. Lea
`Colin B. Heideman
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`Email: BoxSMNPHL.168LP6@knobbe.com
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`Page No.
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`TABLE OF CONTENTS
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`MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1) ........................ 1
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) .......................... 1
`
`Related Matters Under 37 C.F.R. § 42.8(b)(2) ................................... 1
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`Lead and Back-up Counsel Under 37 C.F.R. § 42.8(b)(3) .................. 2
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`Service Information Under 37 C.F.R. § 42.8(b)(4) ............................. 2
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`Grounds for Standing Under 37 C.F.R. § 42.104(a) ........................... 3
`
`SUMMARY OF ISSUES PRESENTED...................................................... 3
`
`INTRODUCTION & STATE OF THE ART ............................................... 6
`
`A. Knee Joint Anatomy .......................................................................... 6
`
`B.
`
`C.
`
`Knee Replacement Procedures ........................................................... 8
`
`Using Imaging to Create Patient-Specific Guides .............................. 9
`
`Using Imaging to Create Patient-Specific Instruments With
`1.
`Tool Guides Was Well-Known .......................................................... 9
`
`Using Imaging to Determine the Contour of Joint Surfaces Was
`2.
`Well-Known .....................................................................................10
`
`I.
`
`II.
`
`III.
`
`IV. THE ’827 PATENT ....................................................................................13
`
`A. Overview ..........................................................................................13
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`B.
`
`C.
`
`D.
`
`Prosecution History...........................................................................15
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`Priority ..............................................................................................16
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`Level of Ordinary Skill in the Art .....................................................16
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`V.
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`CLAIM CONSTRUCTION ........................................................................17
`
`i
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`Page No.
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`TABLE OF CONTENTS
`(cont’d.)
`
`A.
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`“References the Osteophyte” ............................................................17
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`VI. STATEMENT OF PRECISE RELIEF REQUESTED ................................18
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`A.
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`Status of References as Prior Art ......................................................19
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`VII. SPECIFIC PROPOSED GROUNDS FOR REJECTION ............................20
`
`A. Ground 1: Claims 1-13, 32, 33, 38, and 44-46 Are Unpatentable
`Under § 103(a) Over Radermacher in Combination With Alexander ..........20
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`1.
`
`Claim 1 ...................................................................................20
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`Patient-Specific Surgical Instrument Having a Patient-
`a.
`Specific Surface ......................................................................20
`
`The Patient-Specific Surface Includes Cartilage
`b.
`Information .............................................................................22
`
`i.
`
`ii.
`
`Radermacher .......................................................23
`
`The Knowledge of a POSITA .............................24
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`iii. Alexander ...........................................................26
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`The Corresponding Portion of the Diseased or Damaged
`c.
`Joint Includes an Osteophyte...................................................29
`
`d.
`
`
`The Patient-Specific Surface References the Osteophyte
`29
`
`i.
`
`ii.
`
`Radermacher .......................................................29
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`The Knowledge of a POSITA .............................30
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`iii. Alexander ...........................................................31
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`e.
`
`Guide to Accommodate a Surgical Tool .......................31
`
`ii
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`Page No.
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`TABLE OF CONTENTS
`(cont’d.)
`
`Claims 2 and 3 ........................................................................33
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`Claims 4 and 5 ........................................................................35
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`Claims 6-13, 32, 33, 38, and 44-46 .........................................36
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`2.
`
`3.
`
`4.
`
`Ground 2: Claims 14-19, 22-25, 28, 29, 34-37, and 39-43 Are
`B.
`Unpatentable As Obvious Over Radermacher in Combination with
`Alexander and Woolson ..............................................................................49
`
`1.
`
`2.
`
`3.
`
`4.
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`5.
`
`6.
`
`7.
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`Claims 14-18 and 41-42 ..........................................................49
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`Claims 19 and 43 ....................................................................53
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`Claim 22 .................................................................................55
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`Claims 39 and 40 ....................................................................59
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`Claim 23 .................................................................................60
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`Claims 24, 25, 28, and 29 ........................................................61
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`Claims 34-37 ..........................................................................63
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`Ground 3: Claims 20 and 21 Are Unpatentable As Obvious Over
`C.
`Radermacher in Combination With Alexander, Woolson, and Hofmann. ...78
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`D. Ground 4: Claims 1-13, 32, 33, 38, and 44-46 Are Unpatentable As
`Obvious Over Radermacher in Combination With Fell. ..............................81
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`E.
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`Grounds 5-6 ......................................................................................85
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`VIII. SECONDARY CONSIDERATIONS OF NONOBVIOUSNESS ...............85
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`IX. CONCLUSION ..........................................................................................86
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`
`
`iii
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`Page No(s).
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`
`
`TABLE OF AUTHORITIES
`
`
`In re Am. Acad. of Sci. Tech Ctr.,
`367 F.3d 1359 (Fed. Cir. 2004) ........................................................................ 17
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) ..................................................................................... 17
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ................................................................................... 25, 35
`
`Leapfrog Enters. Inc. v. Fisher-Price, Inc.,
`485 F.3d 1157 (Fed. Cir. 2007) ........................................................................ 85
`
`Newell Cos. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988) .......................................................................... 85
`
`OTHER AUTHORITIES
`
`35 U.S.C. § 102 .............................................................................................. 16, 19
`
`35 U.S.C. § 103 .................................................................................................... 20
`
`35 U.S.C. §§ 311-319 ............................................................................................. 1
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`37 C.F.R. § 42.8 .................................................................................................. 1, 2
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`37 C.F.R. § 42.100 ............................................................................................ 1, 17
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`37 C.F.R. § 42.104 .................................................................................................. 3
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`MPEP § 2111 ........................................................................................................ 17
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`
`
`iv
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`EXHIBIT LIST
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`Exhibit No.
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`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`U.S. Patent No. 8,657,827 (“the ’827 patent”)
`
`Declaration of Jay D. Mabrey, M.D.
`
`PCT Publication No. WO 93/25157 (“Radermacher”)
`
`PCT Publication No. WO 00/35346 (“Alexander”)
`
`PCT Publication No. WO 00/59411 (“Fell”)
`
`U.S. Patent No. 6,712,856 (“Carignan”)
`
`PCT Publication No. WO 95/28688 (“Swaelens”)
`
`U.S. Patent No. 6,510,334 ( “Schuster II”)
`
`U.S. Patent No. 5,098,383 (“Hemmy”)
`
`European Patent No. EP 0 908 836 (“Vomlehn”)
`
`U.S. Patent No. 4,502,483 (“Lacey”)
`
`U.S. Patent No. 6,575,980 (“Robie”)
`
`U.S. Patent No. 5,735,277 (“Schuster ’277”)
`
`U.S. Patent No. 5,320,102 (“Paul”)
`
`J.B. Antoine Maintz & Max A. Viergever, A Survey of Medical
`Image Registration, 2 Med. Image Analysis 1 (1998) (“Maintz”)
`
`PCT Publication No. WO 02/22014 (“WO ’014”)
`
`Excerpts of the ’827 Patent Prosecution History
`
`Exhibit List, Page 1
`
`
`
`
`
`Exhibit No.
`
`Description
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`Exhibit Number Not Used
`
`CV of Jay D. Mabrey, M.D.
`
`Exhibit Number Not Used
`
`U.S. Provisional Patent Application No. 60/293488 (filed May 25,
`2001) (“the ’488 application”)
`
`U.S. Provisional Patent Application No. 60/363527 (filed March
`12, 2002) (“the ’527 application”)
`
`1023
`
`Exhibit Number Not Used
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`Excerpts from ConforMIS, Inc.’s Preliminary Invalidity and
`Noninfringement Disclosures in ConforMIS, Inc. v. Smith &
`Nephew, Inc., Civil Action No. 1:16-cv-10420-IT (D. Mass.)
`
`U.S. Provisional Patent Application No. 60/380692 (filed May 14,
`2002) (“the ’692 application”)
`
`U.S. Provisional Patent Application No. 60/380695 (filed May 14,
`2002) (“the ’695 application”)
`
`U.S. Patent Application No. 10/160667 (filed May 28, 2002) (“the
`’667 application”)
`
`U.S. Patent No. 7,468,075 (“the ’075 patent”)
`
`U.S. Patent No. 7,618,451 (“the ’451 patent”)
`
`Exhibit Number Not Used
`
`U.S. Patent No. 4,841,975 (“Woolson”)
`
`U.S. Patent No. 4,646,729 (“Kenna”)
`
`Exhibit List, Page 2
`
`
`
`
`
`Exhibit No.
`
`Description
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`Klaus Radermacher et al., Computer Assisted Orthopaedic Surgery
`with Image Based Individual Templates, 354 Clinical
`Orthopaedics and Related Research 28 (1998) (“CAOS”)
`
`International Publication No. WO 01/66021 (“Pinczewski”)
`
`Exhibit Number Not Used
`
`U.S. Patent No. 4,759,350 (“Dunn”)
`
`Excerpts from Surgery of the Knee (John N. Insall et al., eds., 2d
`ed. 1993) (“Insall”)
`
`1038-1040 Exhibit Numbers Not Used
`
`1041
`
`1042
`
`Smith & Nephew Richards, Genesis® Total Knee System Primary
`Surgical Technique (1993) (“Genesis Technique Guide”)
`
`Excerpts from Dror Paley, Principles of Deformity Correction
`(2002) (“Principles of Deformity Correction”)
`
`1043
`
`U.S. Patent No. 5,107,824 (“Rogers”)
`
`1044-1065 Exhibit Numbers Not Used
`
`1066
`
`1067
`
`1068
`
`1069
`
`Felix Fernandez-Madrid et al., MR Features of Osteoarthritis of
`the Knee, 12 Magnetic Resonance Imaging 703-09 (1994)
`(“Fernandez-Madrid”)
`
`C-J. Menkes et al., Are Osteophytes Good or Bad?, 12
`OsteoArthritis and Cartilage S53-S54 (2004) (“Menkes”)
`
`C. G. Peterfy et al., Whole-Organ Magnetic Resonance Imaging
`Score (WORMS) of the Knee in Osteoarthritis, 12 OsteoArthritis
`and Cartilage 177-90 (2004) (“Peterfy”)
`
`Excerpts from Jarrold H. Mink et al., Magnetic Resonance
`Imaging of the Knee (1987)
`
`Exhibit List, Page 3
`
`
`
`
`
`Exhibit No.
`
`Description
`
`1070
`
`1071
`
`1072
`
`1073
`
`1074
`
`1075
`
`1076
`
`1077
`
`1078
`
`1079
`
`1080
`
`U.S. Provisional Patent Application No. 60/416601 (Filed on
`October 7, 2002) (“the ’601 application”)
`
`U.S. Publication 2004/0133276 (“Lang”)
`
`U.S. Patent No. 7,534,263 (“Burdulis Jr.”)
`
`U.S. Patent No. 7,634,119 (“Tsougarakis”)
`
`U.S. Provisional Patent Application No. 60/894744 (Filed
`February 6, 2007) (“the ’744 application”)
`
`U.S. Provisional Patent Application No. 60/975028 (Filed on
`March 14, 2007) (“the ’028 application”)
`
`U.S. Provisional Patent Application No. 60/765592 (Filed on
`February 6, 2006) (“the ’592 application”)
`
`U.S. Provisional Patent Application No. 60/785168 (Filed on
`March 2006) (“the ’168 application”)
`
`U.S. Provisional Patent Application No. 60/788339 (Filed on
`March 31, 2006) (“the ’339 application”)
`
`U.S. Provisional Patent Application No. 60/431176 (The
`December 4, 2002) (“the ’176 application”)
`
`U.S. Provisional Patent Application No. 60/467686 (Filed on May
`2, 2003) (“the ’686 application”)
`
`1081-1089 Exhibit Numbers Not Used
`
`1090
`
`Aaron A. Hofmann et al., Effect of the Tibial Cut on Subsidence
`Following Total Knee Arthroplasty, 269 Clinical Orthopaedics and
`Related Research 63 (1991) (“Hofmann”)
`
`1091-1095 Exhibit Numbers Not Used
`
`Exhibit List, Page 4
`
`
`
`
`
`Exhibit No.
`
`Description
`
`1096
`
`Excerpts from ConforMIS, Inc.’s Opening Claim Construction
`Brief in ConforMIS, Inc. v. Smith & Nephew, Inc., Civil Action
`No. 1:16-cv-10420-IT (D. Mass.)
`
`Exhibit List, Page 5
`
`
`
`Smith & Nephew, Inc.
`IPR of U.S. Pat. 8,657,827
`
`
`Petitioner Smith & Nephew, Inc. (“Petitioner” or “Smith & Nephew”)
`
`hereby requests inter partes review in accordance with 35 U.S.C. §§ 311-319 and
`
`37 C.F.R. § 42.100 et seq. of Claims 1-25, 28-29, and 32-46 of U.S. Pat. No.
`
`8,657,827 (“the ’827 patent”), which issued on February 25, 2014, and is
`
`purportedly owned by ConforMIS, Inc. (“ConforMIS”).
`
`
`
`I. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1)
`
`A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1)
`
`Smith & Nephew is the real party-in-interest. Smith & Nephew is a wholly
`
`owned subsidiary of Smith & Nephew plc, which is publicly traded on the London
`
`Stock Exchange.
`
`B. Related Matters Under 37 C.F.R. § 42.8(b)(2)
`
`ConforMIS asserted the ’827 patent (Ex. 1001) against Smith & Nephew in
`
`co-pending litigation captioned ConforMIS, Inc. v. Smith & Nephew, Inc., No.
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`1:16-cv-10420-IT (D. Mass. filed February 29, 2016 and served March 1, 2016).
`
`Petitioner filed petitions requesting inter partes review of related ConforMIS
`
`patents: U.S. Patent Nos. 9,055,953 (IPR2016-01874); 9,216,025 (IPR2017-00115
`
`and 2017-00307); 8,377,129 (IPR2017-00372); 8,551,169 (IPR2017-00373);
`
`9,295,482 (IPR2017-00487 and -00488); 7,981,158 (IPR2017-00510 and -00511);
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`7,534,263 (IPR2017-00544 and -00545); and 8,062,302 (IPR2017-00778, -00779,
`
`1
`
`
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`Smith & Nephew, Inc.
`IPR of U.S. Pat. 8,657,827
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`and -00780). Petitioner is filing a petition challenging Claims 50-64 of the ’827
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`patent concurrently herewith.
`
`C. Lead and Back-up Counsel Under 37 C.F.R. § 42.8(b)(3)
`
`Smith & Nephew provides the following designation of counsel, all of
`
`whom are included in Customer No. 20,995 identified in Smith & Nephew’s
`
`Power of Attorney:
`
`
`
`
`
`Lead Counsel
`Christy G. Lea (Reg. No. 51,754)
`2cgl@knobbe.com
`Postal and Hand-Delivery Address:
`Knobbe, Martens, Olson & Bear, LLP
`2040 Main St., 14th Fl.
`Irvine, CA 92614
`Telephone: (949) 760-0404
`Facsimile: (949) 760-9502
`
`Backup Counsel
`Joseph Re (Reg. No. 31,291)
`2jrr@knobbe.com
`Postal and Hand-Delivery Address:
`Knobbe, Martens, Olson & Bear, LLP
`2040 Main Street, 14th Fl.
`Irvine, CA 92614
`Telephone: (949) 760-0404
`Facsimile: (949) 760-9502
`
`Colin B. Heideman (Reg. No. 61,513)
`2cbh@knobbe.com
`Postal and Hand-Delivery Address:
`Knobbe, Martens, Olson & Bear, LLP
`925 Fourth Ave., Suite 2500
`Seattle, WA 98104
`Telephone: (206) 405-2000
`Facsimile: (206) 405-2001
`
`D.
`
`Service Information Under 37 C.F.R. § 42.8(b)(4)
`
`Please address all correspondence to lead and back-up counsel at the address
`
`shown above. Smith & Nephew also consents to electronic service by email to
`
`BoxSMNPHL.168LP6@knobbe.com.
`
`2
`
`
`
`Smith & Nephew, Inc.
`IPR of U.S. Pat. 8,657,827
`
`
`E. Grounds for Standing Under 37 C.F.R. § 42.104(a)
`
`Petitioner certifies that the ’827 patent is available for inter partes review
`
`and that Petitioner is not barred or estopped from requesting an inter partes review
`
`challenging the patent claims on the grounds identified in this petition. This
`
`Petition is being filed within one year of service of the original complaint against
`
`Petitioner in the district court litigation.
`
`II. SUMMARY OF ISSUES PRESENTED
`
`Claims 1-25, 28, 29, and 32-461 of the ’827 patent recite a simple surgical
`
`instrument for preparing a bone (e.g., the femur or tibia in knee replacement
`
`surgery) to receive an implant. The claimed instrument has two basic features: (a)
`
`a patient-specific surface that includes cartilage information and “references” an
`
`osteophyte (e.g., bone spur) of a patient’s joint; and (b) a guide for surgical tools.
`
`According to ConforMIS, Figures 32 and 33 (below)2 show the purported
`
`invention, i.e., a surgical instrument (green) having a patient-specific surface
`
`(yellow) that matches a surface of the patient’s joint, references (e.g., engages or
`
`avoids) an osteophyte, and guides a saw (not shown) to make cuts (shown as dotted
`
`lines) in the bone (blue).
`
`
`1 Claim 1 is the only independent claim.
`2 For clarity, diagrams are colored and annotated.
`
`3
`
`
`
`Smith & Nephew, Inc.
`IPR of U.S. Pat. 8,657,827
`
`
`
`
`There was nothing inventive about such an instrument at the time the ’827
`
`patent was filed. By the 1990s, instruments having patient-specific surfaces were
`
`widely-known and described in numerous prior art references. For example, in
`
`1993, Radermacher disclosed an instrument (“individual template 4”) having
`
`guides (cutting guides defining planes 20a-d and a drill guide about axis 8), as well
`
`as a patient-specific surface (“contact faces 1”) that was customized based on CT
`
`and/or MRI data to match the natural surface of a patient’s knee joint:
`
`4
`
`
`
`Smith & Nephew, Inc.
`IPR of U.S. Pat. 8,657,827
`
`
`
`
`Numerous other references similarly disclosed instruments containing patient-
`
`specific surfaces and tool guides.
`
`The primary difference between the ’827 patent and Radermacher is that the
`
`’827 patent expressly requires the patient-specific surface to “reference” (e.g.,
`
`engage or avoid) an osteophyte. But osteophytes were commonly known and
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`naturally occurring. It was widely-known that osteophytes (and other deformities)
`
`would be reflected in preoperative imaging and should be accounted for when
`
`planning surgery.
`
`In view of the prior art, the challenged claims of the ’827 patent should have
`
`never issued. The claims slipped through the Patent Office with minimal
`
`5
`
`
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`Smith & Nephew, Inc.
`IPR of U.S. Pat. 8,657,827
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`substantive examination despite
`
`invalidating—prior art.
`
`the vast array of highly relevant—and
`
`III.
`
`INTRODUCTION & STATE OF THE ART
`
`A. Knee Joint Anatomy
`
`The knee joint includes the femur (thigh bone), the tibia (shin bone), and the
`
`patella (knee cap):
`
`
`
`Ex. 1002 ¶36. In a healthy knee, the lower end of the femur and the upper end of
`
`the tibia are covered by articular cartilage, which provides a low-friction surface
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`that facilitates rotation and absorbs shock. Id. In unhealthy knees, osteophytes,
`
`which are bony outgrowths or deformities, can occur on the articular surface of the
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`femur and tibia. Id. ¶¶36-38.
`
`6
`
`
`
`Smith & Nephew, Inc.
`IPR of U.S. Pat. 8,657,827
`
`
`A patient’s femur and tibia define a “mechanical axis,” which is the axis that
`
`extends from the center of the femoral head at the hip, through the center of the
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`knee, and through the ankle joint, as shown below. Id. ¶¶39-40; Ex. 1036, Fig. 1.
`
`The femur and tibia also each define an “anatomic axis” which, as shown
`
`above, represents the axis that extends along the center of the bone. Ex. 1002
`
`
`
`¶¶39-40.
`
`7
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`
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`Smith & Nephew, Inc.
`IPR of U.S. Pat. 8,657,827
`
`
`B. Knee Replacement Procedures
`
`When articular cartilage has been damaged by disease such as osteoarthritis,
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`a surgeon can replace portions of the knee with artificial components. Id. ¶41.
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`Such surgery, which is referred to as “knee arthroplasty,” was known for decades
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`before the ’827 patent. Id. ¶¶34-35.
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`During knee arthroplasty, a surgeon prepares a patient’s bone to receive an
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`implant by removing a portion of the bone and shaping it to receive the implant.
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`Id. ¶42. The image below shows the end of a femur that has been prepared in a
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`typical manner, with flat bone surfaces for seating an implant and holes for
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`receiving pegs on the implant. Id.
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`Ex. 1011, Fig. 17.
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`To help ensure that the cuts and drill holes are made accurately—and thus
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`the implant component is implanted in the proper orientation—a surgeon typically
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`uses cutting guides with holes, slots, or surfaces that guide the surgeon’s tools as
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`the surgeon cuts (resects) the bone or drills holes into bone. Ex. 1002 ¶43.
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`C. Using Imaging to Create Patient-Specific Guides
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`1.
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`Using Imaging to Create Patient-Specific Instruments With
`Tool Guides Was Well-Known
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`In the 1990s, it was known that patient-specific instruments (sometimes
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`referred to as “blocks” or “cutting guides”) with tool guides could be created based
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`on MRI and/or CT data of a patient’s joint. Ex. 1002 ¶55. For example,
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`Radermacher (1993) described using MRI and/or CT data to create an “individual
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`template” for guiding surgical tools during surgery. The individual template
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`included a surface that is a “copy” or “negative” of the “natural (i.e. not pre-
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`treated) surface” of a patient’s joint. Ex. 1003 at 10, 12. In Radermacher, an
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`individual template 4 having patient-specific contact faces 1 could be set on a bone
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`17 of a patient’s knee joint, a bore axis 8 drilled, and cuts made along cutting
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`planes 20a-d, resulting in a resected bone (Fig. 13b) for seating an implant (Fig.
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`13d):
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`Id. at 30, Fig. 13b.
`2.
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`Using Imaging to Determine the Contour of Joint Surfaces
`Was Well-Known
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`It was well-known for years prior to 2006 (and 2001) that the contour of a
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`patient’s cartilage surface could be determined through MRI and CT images. Ex.
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`1002 ¶¶46-47. Indeed, the ’827 patent admits that “imaging techniques suitable for
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`measuring thickness and/or curvature (e.g., of cartilage and/or bone) or size of
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`areas of diseased cartilage or cartilage loss” were known in the art, and included
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`MRI and CT. Ex. 1001, 32:1-14. The ’827 patent admits that MRI and CT could
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`be used to image “other anatomical structures,” which would include osteophytes.
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`Id., 65:58-66:28; 73:25-50; 83:65-84:7. The patent further admits that the
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`invention employs “conventional” methods of x-ray, ultrasound, CT, and MRI that
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`are “within the skill of the art” and are “explained fully in the literature.” Id.,
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`30:34-52.
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`The prior art confirms that various imaging techniques could be used to
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`determine shape of articular cartilage. For example, Alexander (2000) recognized
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`that “a number of internal imaging techniques known in the art are useful for
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`electronically generating a cartilage image[,]” including MRI and CT. Ex. 1004,
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`14:16-21. Alexander disclosed using MRI to create three-dimensional models of a
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`patient’s knee joint, including both bone and cartilage surfaces:
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`Id., Fig. 18C (cropped). Moreover, Alexander disclosed virtually the same
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`“cartilage image” as in the ’827 patent:
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`’827 Patent (Ex. 1001, Fig. 2)
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`Alexander (Ex. 1004, Fig. 19)
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`In fact, the ’827 patent relies on Alexander’s prior art method of determining the
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`shape of the bone and/or cartilage surfaces to generate the claimed patient-specific
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`instrument. Ex. 1001, 32:1-33:3 (citing WO 02/22014 (Ex. 1016), which is a later
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`publication of Ex. 1004).
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`Many other prior art references also described using MRI to image the
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`cartilage surface. Ex. 1013, 2:8-17 (MRI “makes possible an especially sharp
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`definition of the joint contour by representing the cartilaginous tissue and other
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`soft parts of the damaged knee joints”); see generally Ex. 1014 (articular cartilage
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`shape and thickness can be determined using MRI); Ex. 1005, 22:6-9 (MRI
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`provides contour plots of articular cartilage).
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`The prior art also confirmed that MRI or CT scans could be used to obtain
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`information about osteophytes. Ex. 1004, 39:22-24 (bone may be imaged similar
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`to cartilage), Figs. 10A-C, 12A-B; Ex. 1006, 9:1-6 (CT scan provides three-
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`dimensional contour of bone); Ex. 1067 at S53 (MRI “can provide interesting
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`information with regard to the evolution of osteophytes”); Ex. 1066 at 703, 705-
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`706, Fig. 1; Ex. 1068 at 183-86 (“Osteophytes are also well delineated with
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`MRI[.]”); Ex. 1069 at 123-24. Petitioner’s expert confirms that it was known that
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`MRI and/or CT data provided information about a patient’s cartilage and any
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`osteophytes. Ex. 1002 ¶¶46-49.
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`IV. THE ’827 PATENT
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`A. Overview
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`The ’827 patent describes obtaining images of the joint that “define the
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`articular and/or bone surface and shape” (Ex. 1001, 70:33-35), but admits that
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`those images may be “conventional” x-rays, MRI, CT scans, ultrasound, or other
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`technologies, which were “explained fully in the literature.” Id., 30:34-52, 32:1-
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`33:3.
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`The patent describes using the images to create a cutting guide having a
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`patient-specific surface that is a “mirror image” of the patient’s joint surface, e.g.,
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`the surface of the device “match[es] all or portions of the articular cartilage,
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`subchondral bone and/or other bone surface and shape.” Id., 70:40-43, 70:35-40,
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`96:41-43, 96:46-48, 8:63-67, 97:6-9, 118:31-38.
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`
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`The patent also states that the patient-specific surface may engage an
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`osteophyte (Fig. 33), or include a recess to avoid the osteophyte (Fig. 32). Id.,
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`83:45-84:7, 73:25-50.
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`The patent also explains that the bone may be resected (e.g., along line
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`1958) “perpendicular to the mechanical axis 1910.” Id., 69:23-33.
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`Id., Fig. 21B. The patent admits that it was well-known that a patient’s anatomical
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`and mechanical axes could be determined using conventional imaging (x-ray, MRI,
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`CT). Id., 34:42-39:45.
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`The instrument can include apertures, slots and/or holes to accommodate
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`surgical tools such as drills or saws. Id., 70:43-46.
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`B.
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`Prosecution History
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`During prosecution, the Examiner rejected most of the claims as anticipated
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`by U.S. Patent No. 6,712,856 to Carignan or as obvious over Carignan in view of
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`other references. Ex. 1017 at 122-26. ConforMIS amended the independent
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`claims to recite that the patient-specific surface references the osteophyte and the
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`claims were allowed. Id. at 16, 48.
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`Although the references relied on herein (Radermacher, Alexander, Fell, and
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`Woolson) were submitted during prosecution (id. at 153, 155, 163-64), they were
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`among over 600 patent references and over 170 non-patent references submitted to
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`the Examiner. Ex. 1001 at 1-9. These references were never applied by the
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`Examiner.
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`C.
`
`Priority
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`The ’827 patent was filed on November 22, 2011. The ’827 patent cannot
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`have an effective priority date earlier than March 23, 2006, which is the date of the
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`first disclosure of osteophytes in the context of patient-specific instruments.3 Ex.
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`1002 ¶74. Accordingly, all references relied on herein are prior art under § 102(b)
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`because each reference published more than a year before March 23, 2006. Even if
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`the ’827 patent were entitled to an earlier priority date, which it is not, each of the
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`references relied on herein would still be prior art under §§ 102(a), (b) or (e).
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`D. Level of Ordinary Skill in the Art
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`A person of ordinary skill in the art (“POSITA”) would be: (a) an orthopedic
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`surgeon having at least three years of experience in knee arthroplasty surgery; or
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`(b) an engineer having a bachelor’s degree in biomedical engineering (or closely
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`related discipline) who works with surgeons in designing cutting guides and who
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`3 Petitioner does not concede that the ’827 patent is entitled to this priority date.
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`has at least three years of experience learning from these doctors about the use of
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`such devices in joint replacement surgeries. Ex. 1002 ¶¶29-32.
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`V. CLAIM CONSTRUCTION
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`For purposes of this review, the claims are given their broadest reasonable
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`interpretation in light of the specification. Cuozzo Speed Techs., LLC v. Lee, 136
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`S. Ct. 2131, 2142 (2016); 37 C.F.R. § 42.100(b). Because the claim construction
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`standard at the Patent Office is different than that used during a U.S. District Court
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`litigation, see In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364, 1369 (Fed.
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`Cir. 2004), MPEP § 2111, Petitioner reserves the right to argue a different claim
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`construction in litigation.
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`A.
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`“References the Osteophyte”
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`The claims of the ’827 patent recite that the patient-specific surface
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`“references the osteophyte.” The specification does not define the term
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`“reference.” However, the specification describes a patient-specific surface that
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`engages or avoids an osteophyte. Ex. 1001, 73:30-55; 83:50-84:13; Figs. 32-33.
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`During co-pending litigation, ConforMIS has asserted that “references the
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`osteophyte” means “takes the osteophyte into account.” Ex. 1096 at 27-30.
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`ConforMIS contends that, under this construction, a surface “references an
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`osteophyte” if it “conforms to,” “accommodates,” or “avoids” the osteophyte. Id.
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`The broadest reasonable interpretation must include the construction advanced by
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`ConforMIS in litigation, where a narrower claim construction standard applies.
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`Thus, for this proceeding, the phrase “references the osteophyte” includes at least a
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`patient-specific surface that engages or avoids an osteophyte. Ex. 1002 ¶76.
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`VI. STATEMENT OF PRECISE RELIEF REQUESTED
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`Petitioner requests that the Board cancel Claims 1-25, 28, 29, and 32-46 of
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`the ’827 patent as unpatenable under 35 U.S.C. §103 for the following reasons:
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`Ground 1. Claims 1-13, 32, 33, 38, and 44-46 are unpatentable as obvious
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`over Radermacher in combination with Alexander.
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`Ground 2. Claims 14-19, 22-25, 28, 29, 34-37, and 39-43 are unpatentable
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`as obvious over Radermacher in combination with Alexander and Woolson.
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`Ground 3. Claims 20 and 21are unpatentable as obvious over Radermacher
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`in combination with Alexander, Woolson, and Hofmann.
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`Ground 4. Claims 1-13, 32, 33, 38, and 44-46 are unpatentable as obvious
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`over Radermacher in combination with Fell.
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`Ground 5. Claims 14-19, 22-25, 28, 29, 34-37, and 39-43 are unpatentable
`
`as obvious over Radermacher in combination with Fell and Woolson.
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`Ground 6. Claims 20 and 21 are unpatentable as obvious over Radermacher
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`in combination with Fell, Woolson, and Hofmann.
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`Collectively, Grounds 1-3 (collectively) address all challenged claims, as do
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`Grounds 4-6 (collectively). Grounds 4-6 are not redundant of Grounds 1-3 because
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`Grounds 4-6 rely on a different secondary reference (Fell), involving a different
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`but related technology and providing a different motivation to combine. Ex. 1002
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`¶¶193-96.
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`This Petition is supported by the Declaration of Jay D. Mabrey, M.D. Ex.
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`1002. Dr. Mabrey is the Chief of the Department of Orthopaedics at Baylor
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`University Medical Center in Dallas, Texas, and is also a Professor of Surgery at
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`Texas A&M Health Science Center College of Medicine. Id. ¶8.
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`A.
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`Status of References as Prior Art
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`All the references relied on are prior art under 35 U.S.C. § 102(b) because
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`they published more than one year before the earliest possible priority date:
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` Radermacher published on December 23, 1993.
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` Alexander published on June 22, 2000.
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` Fell published on October 12, 2000.
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` Woolson published on June 27, 1989.
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`VII. SPECIFIC PROPOSED GROUNDS FOR REJECTION
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`A. Ground 1: Claims 1-13, 32, 33, 38, and 44-46 Are Unpatentable
`Under § 103(a) Over Radermacher in Combination With
`Alexander
`1.
`Claim 1 recites a patient-specific surgical ins
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