UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`DEPUY SYNTHES SALES, INC. and
`
`DEPUY SYNTHES PRODUCTS, INC.,
`
`Petitioners
`
`v.
`
`Patent Owner of
`U.S. Patent No. 6,099,531 to Bonutti
`Appl. No. 09/137,443 filed Aug. 20, 1998
`Issued Aug. 8, 2000
`
`IPR Trial No. TBD
`
`
`
`PETITION FOR INTER PARTES
`REVIEW OF U.S. PATENT NO. 6,099,531
`PURSUANT TO 35 U.S.C. § 312 AND 37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`
`TABLE OF CONTENTS
`
`I.
`
`
`
`Introduction ..............................................................................................1
`
`II.
`
` Mandatory Notices (37 C.F.R. § 42.8) ........................................................2
`
`A.
`
`
`
`B.
`
`
`
`C.
`
`
`
`D.
`
`
`
`Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) ..................................2
`
`Related Matters (37 C.F.R. § 42.8(b)(2))...........................................2
`
`Lead and Back-up Counsel (37 C.F.R. § 42.8(b)(3)) ..........................4
`
`Service Information (37 C.F.R. § 42.8(b)(4)) ....................................4
`
`III.
`
`
`
`Fee Payment Authorization (37 C.F.R. § 42.103) ........................................5
`
`IV.
`
` Grounds for Standing (37 C.F.R. § 42.104(a)) ............................................5
`
`V.
`
`
`
`Identification of Challenge (37 C.F.R. § 42.104(b)) ....................................5
`
`A.
`
`
`
`B.
`
`
`
`Effective Filing Date of the ‘531 Patent ............................................5
`
`Prior Art and Statutory Grounds for the Challenge (37 C.F.R. §
`42.104(b)) .......................................................................................6
`
`1.
`
`
`
`2.
`
`
`
`3.
`
`
`
`4.
`
`
`
`5.
`
`
`
`6.
`
`
`
`U.S. Patent No. 6,008,433 to Stone et al. (“Stone”) (Ex. 1005) .6
`
`U.S. Patent No. 5,298,254 to Prewett et al. (“Prewett”) (Ex.
`1006) .....................................................................................6
`
`U.S. Patent No. 6,066,175 to Henderson et al. (“Henderson”)
`(Ex. 1007)..............................................................................7
`
`U.S. Pat. No. 5,766,251 to Koshino (“Koshino”) (Ex. 1008) ....7
`
`French Patent Application No. FR 2,747,034 to Benezech et al.
`(“Benezech”) (Ex. 1009) ........................................................7
`
`French Patent Application No. FR 2,703,580 to Gilles
`(“Gilles”) (Ex. 1011) ..............................................................8
`
`VI.
`
` Summary of the ‘531 Patent..................................................................... 10
`
`A.
`
`
`
`B.
`
`
`
`C.
`
`
`
`D.
`
`
`
`Summary of the Patent ................................................................... 10
`
`Prosecution History of the ‘531 Patent ............................................ 12
`
`Level of Ordinary Skill in the Art ................................................... 12
`
`Claim Construction (37 C.F.R. § 42.104(b)(3)) ............................... 13
`
`1.
`
`
`
`“movable into the joint between first and second bones” ........ 14
`
`VII.
`
` Detailed Explanation (37 CFR 42.104(b)(4)-(5))....................................... 15
`
`
`
`i
`
`

`
`A.
`
` General State of the Art.................................................................. 15
`
`B.
`
`
`
`Ground 1 – The Challenged Claim Is Anticipated by Stone or,
`Alternatively, Obvious over Stone in View of Prewett, Henderson
`and/or Koshino .............................................................................. 18
`
`C.
`
` Ground 2 – The Challenged Claim is Obvious over Benezech in View
`of Gilles ........................................................................................ 32
`
`D.
`
` Any Secondary Considerations of Nonobviousness Fail to Overcome
`the Strong Prima Facie Showing of Obviousness ............................ 41
`
`VIII.
`
` Conclusion .............................................................................................. 41
`
`
`
`
`
`
`
`
`
`ii
`
`

`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Page(s)
`
`Biomet Inc. v. Bonutti Skeletal Innovations LLC,
`No. 13-176-JVB (N.D. In.) ............................................................................. 2
`
`Bonutti Skeletal Innovations, LLC v. DePuy Synthes Sales, Inc. and
`DePuy Synthes Products, Inc.,
`No. 14-14680-IT (D. Mass.) ........................................................................... 2
`
`Bonutti Skeletal Innovations LLC v. Globus Medical Inc.,
`No. 14-6650-WB (E.D. Pa.)............................................................................ 2
`
`In re ICON Health & Fitness, Inc.,
`496 F.3d 1374 (Fed. Cir. 2007) ..................................................................... 13
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) .................................................................... 21, 29, 37, 38
`
`Nautilus, Inc. v. Bioig Instruments, Inc.,
`134 S.Ct. 2120 (2014) .................................................................................. 13
`
`Ohio Willow Wood Co. v. Alps S., LLC,
`735 F.3d 1333 (Fed. Cir. 2013) ..................................................................... 41
`
`Pitney Bowes, Inc. v. Hewlett-Packard Co.,
`182 F.3d 1298 (Fed. Cir. 1999) ............................................................... 18, 32
`
`Q.I. Press Controls, B.V. v. Lee,
`752 F.3d 1371 (Fed. Cir. 2014) ..................................................................... 41
`
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) ..................................................................... 15
`
`Superior Indus., Inc. v. Masaba, Inc.,
`553 F. App’x 986 (Fed. Cir. 2014) (Rader, concurring).................................. 14
`
`Statutes
`
`35 U.S.C. § 102 et seq ..............................................................................1, 6, 7, 8
`
`
`
`iii
`
`

`
`35 U.S.C. § 103 .......................................................................................... 1, 8, 9
`
`35 U.S.C. § 311 et seq. ........................................................................................ 1
`
`35 U.S.C. § 314 .................................................................................................. 1
`
`Other Authorities
`
`37 C.F.R. § 42.1 et seq. ....................................................................................... 1
`
`37 C.F.R. § 42.8 et seq .................................................................................... 2, 4
`
`37 C.F.R. § 42.10(b) ........................................................................................... 4
`
`37 C.F.R. § 42.15(a)............................................................................................ 5
`
`37 C.F.R. §§ 42.22(a)(1) and 42.104(b)(1)-(2)...................................................... 5
`
`37 C.F.R. § 42.100(b)........................................................................................ 13
`
`37 C.F.R. § 42.103 .............................................................................................. 5
`
`37 C.F.R. § 42.104 et seq ..........................................................................5, 6, 13
`
`37 C.F.R. § 42.108 .............................................................................................. 1
`
`37 C.F.R. §§ 42.104(B)(4)-(5) ........................................................................... 15
`
`M.P.E.P. § 2111.02 ..................................................................................... 18, 32
`
`M.P.E.P § 2114(II)...................................................................................... 14, 15
`
`
`
`iv
`
`
`
`
`
`

`
`Exhibit No.
`
`Description
`
`Short Reference
`
`EXHIBIT LIST
`
`U.S. Patent No. 6,099,531
`
`the ‘531 patent
`
`Declaration of Dr. Carl McMillin
`
`McMillin Decl.
`
`Curriculum Vitae of Dr. Carl McMillin McMillin CV
`
`List of Prior Art and Other Materials
`Considered by Dr. Carl McMillin
`
`McMillin Materials
`Considered
`
`U.S. Patent No. 6,008,433
`
`U.S. Patent No. 5,298,254
`
`U.S. Patent No. 6,066,175
`
`U.S. Patent No. 5,766,251
`
`French Patent Application No. FR
`2,747,034
`
`Certified translation of French Patent
`Application No. FR 2,747,034 to
`Benezech et al.
`
`Stone
`
`Prewett
`
`Henderson
`
`Koshino
`
`Benezech
`
`Benezech Translation
`
`French Patent Application No. FR
`2,703,580
`
`Gilles
`
`Gilles Translation
`
`
`
`
`
`
`
`
`
`
`
`
`
`Certified translation of French Patent
`Application No. FR 2,703,580 to Gilles
`et al.
`
`U.S. Patent Application No. 09/137,443
`
`Office Action, dated August 20, 1999
`
`Amendment, dated October 28, 1999
`
`Notice of Allowability, dated February
`3, 2000
`
`Decision Denying Institution of Inter
`Partes Review, IPR2015-01346
`
`Decision Instituting Inter Partes
`Review, IPR2015-01339
`
`
`
`v
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`
`
`
`
`

`
`FIGURES AND TABLES
`
`Figure No.
`
`Description
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`Figure 2 of the ‘531 Patent
`
`Figure 9 of the ‘531 Patent
`
`Curvature of the Spine
`
`Wedge-shaped intervertebral implant with two passages (annotated)
`
`Figure 3C of Stone and Figure 2 of ‘531 Patent
`
`Figure 6 of Prewett
`
`Figure 1A of Stone (annotated)
`
`Figure 1A of Stone
`
`Illustration of Stone disclosure of plurality of passages
`
`Figure 10 of the ‘531 Patent
`
`Figure 1 of Koshino
`
`Figure 2 of Benezech (annotated)
`
`Figure 1 of Gilles (annotated)
`
`Figure 1 of Gilles (annotated)
`
`Figure 2 of Benezech
`
`Figure 1 of Gilles
`
`Table No.
`
`Description
`
`1
`
`2
`
`3
`
`Grounds for Inter Partes Review
`
`Ground 1 – The Challenged Claim Is Anticipated by Stone or,
`Alternatively, Obvious Over Stone in View of Prewett, Henderson
`and/or Koshino
`
`Ground 2 – The Challenged Claim Is Obvious Over Benezech in
`View of Gilles
`
`vi
`
`
`
`
`
`
`
`

`
`I.
`
`
`
`INTRODUCTION
`
`Pursuant to 35 U.S.C. § 311 et seq. and 37 C.F.R. § 42.1 et seq., DePuy
`
`Synthes Sales, Inc. and DePuy Synthes Products, Inc. (“Petitioners”), hereby
`
`submit this petition for inter partes review (“Petition”) of U.S. Patent
`
`No. 6,099,531 (“the ‘531 patent”), attached hereto as Ex. 1001. Petitioners
`
`respectfully submit that Independent Claim 105 (the “Challenged Claim”) is
`
`unpatentable under 35 U.S.C. § 102 and/or § 103 in view of the prior art discussed
`
`herein.
`
`The Challenged Claim is directed to a wedge for use in a patient’s
`
`body. There was nothing novel about the Challenged Claim as of August 20, 1998,
`
`the earliest effective filing date of the ‘531 patent. The wedge is one of the six
`
`simple machines used since the dawn of civilization and, as the prior art presented
`
`in this Petition demonstrates, orthopedic and spine surgeons had been using
`
`wedge-shaped implants for decades. The only additional element of the
`
`Challenged Claim are openings in the wedge to enable bone to grow through the
`
`wedge. This was standard practice in the orthopedic and spinal implant art as of
`
`1998.
`
`Accordingly, Petitioners respectfully request that the Board institute an inter
`
`partes review of the ‘531 patent pursuant to 35 U.S.C. § 314 and
`
`37 C.F.R. § 42.108.
`
`
`
`1
`
`

`
`II.
`
` MANDATORY NOTICES (37 C.F.R. § 42.8)
`
`A.
`
` Real Party-In-Interest (37 C.F.R. § 42.8(b)(1))
`
`Petitioners are the real party-in-interest. The following corporations are
`
`related to Petitioners: Johnson & Johnson; Johnson & Johnson International;
`
`DePuy Synthes, Inc.; Synthes, Inc.; DePuy Orthopaedics, Inc.; Codman &
`
`Shurtleff, Inc.; DePuy Products, Inc.; Synthes USA, LLC; DePuy Spine, LLC.
`
`
`
` Related Matters (37 C.F.R. § 42.8(b)(2)) B.
`
`The following litigation matter would affect or be affected by a decision in
`
`this proceeding: Bonutti Skeletal Innovations, LLC v. DePuy Synthes Sales, Inc.
`
`and DePuy Synthes Products, Inc., No. 14-14680-IT (D. Mass.) (“the Pending
`
`Litigation”). The litigation involves six patents: the ‘531 patent, U.S. Patent
`
`No. 6,423,063 (“the ‘063 patent”), U.S. Patent No. 7,001,385 (“the ‘385 patent”),
`
`U.S. Patent No. 8,486,066 (“the ‘066 patent”), U.S. Patent No. 8,690,944, and U.S.
`
`Patent No. 8,795,363 (“the ‘363 patent”). Certain claims of the ‘531 patent are the
`
`subject of this Petition. Petitioners are a party to the Pending Litigation.
`
`The following litigation matters would also affect or be affected by a
`
`decision in this proceeding: Bonutti Skeletal Innovations LLC v. Globus Medical
`
`Inc., No. 14-6650-WB (E.D. Pa.) and Biomet Inc. v. Bonutti Skeletal Innovations
`
`LLC, No. 13-176-JVB (N.D. In.). Both litigation matters involve the ‘531 patent.
`
`Petitioners are concurrently filing four additional petitions for inter partes
`
`
`
`2
`
`

`
`review that will address (i) certain claims of the ‘063 patent, (ii) certain claims of
`
`the ‘385 patent, (iii) certain claims of the ‘066 patent and (iv) certain claims of the
`
`‘363 patent. The ‘063 patent and the ‘385 patent are related to the ‘531 patent
`
`through continuation practice. Petitioners understand that all five patents are
`
`owned by Bonutti Skeletal Innovations LLC.
`
`On December 16, 2105, the Patent Trial and Appeal Board (“the Board”)
`
`denied institution of IPR2015-01346, which included the Challenged Claim of the
`
`‘531 patent. The petitioner asserted Stone in combination with Prewett, and the
`
`Board held that Stone’s disclosure of porous surfaces is not a disclosure of “a
`
`plurality of passages which extend between said first and second major side
`
`surfaces for enabling bone to grow through said wedge member.” As discussed
`
`below, however, the petitioner and Patent Owner both failed to point the Board to
`
`the relevant portions of the Stone specification that contain explicit disclosures of
`
`passages that extend between the surfaces and enable the bone to grow through the
`
`wedge.
`
`Furthermore, as Dr. McMillin explains and as discussed below, the Board’s
`
`reasoning that bone graft inserted inside the wedge of Stone would effectively
`
`block the wedge’s passages (Ex. 1017, p. 16) is incorrect because such passages,
`
`like the passages of the ‘531 patent, are designed to promote bone fusion through
`
`the wedge, and the inclusion of bone graft in the passages would have been the
`
`
`
`3
`
`

`
`preferred and obvious design choice to the person of ordinary skill. Moreover, the
`
`Challenged Claim is an apparatus claim and therefore, even under the Board’s
`
`reasoning, Stone’s instruction to use its wedge by filling it with bone graft does not
`
`negate that the wedge itself is hollow and has unobstructed passages.
`
`
`
` Lead and Back-up Counsel (37 C.F.R. § 42.8(b)(3)) C.
`
`Petitioners designate the following as lead and back-up counsel, all with
`
`Axinn, Veltrop & Harkrider LLP:
`
`Lead Counsel
`
`Back-up Counsel
`
`Jeremy Lowe, Reg. No. 48,085
`90 State House Square, 9th Floor
`Hartford, CT 06103
`Tel: 860-275-8100
`Fax: 860-275-8101
`jlowe@axinn.com
`Matthew J. Becker, Reg. No. 40,507
`90 State House Square, 9th Floor
`Hartford, CT 06103
`Tel: 860-275-8100
`Fax: 860-275-8101
`mbecker@axinn.com
`
`Dan Feng Mei, Reg. No. 71,518
`114 West 47th Street, 22nd Floor
`New York, NY 10036
`Tel: 212-728-2200
`Fax: 212-728-2201
`dmei@axinn.com
`David K. Ludwig, Reg. No. 69,377
`90 State House Square, 9th Floor
`Hartford, CT 06103
`Tel: 860-275-8100
`Fax: 860-275-8101
`dludwig@axinn.com
`
` A
`
` power of attorney is submitted herewith pursuant to 37 C.F.R. § 42.10(b).
`
`
`D.
`
`Service Information (37 C.F.R. § 42.8(b)(4))
`
`Service of any documents via hand-delivery may be made at the postal
`
`mailing addresses of lead and back-up counsel identified above with courtesy
`
`copies to the following email addresses: jlowe@axinn.com, mbecker@axinn.com,
`
`dmei@axinn.com and dludwig@axinn.com. Petitioners consent to electronic
`
`
`
`4
`
`

`
`service at these same email addresses.
`
`III.
`
` FEE PAYMENT AUTHORIZATION (37 C.F.R. § 42.103)
`
`In accordance with 37 C.F.R. § 42.103(a), Petitioner authorizes the Patent
`
`Office to charge Deposit Account No. 013050 for the fees set forth in 37 C.F.R.
`
`§ 42.15(a). If payment of additional fees is due during this proceeding, the Patent
`
`Office is authorized to charge such fees to Deposit Account No. 013050, and credit
`
`any overpayment to the same account.
`
`IV.
`
` GROUNDS FOR STANDING (37 C.F.R. § 42.104(a))
`
`Pursuant to 37 C.F.R. § 42.104(a), Petitioners certify that the ‘531 patent is
`
`eligible for inter partes review and that Petitioners are not barred or estopped from
`
`requesting such review.
`
`V.
`
`
`
`IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(b))
`
`Pursuant to 37 C.F.R. §§ 42.22(a)(1) and 42.104(b)(1)-(2), Petitioners
`
`respectfully request inter partes review of the Challenged Claims and request that
`
`the challenged claims be cancelled.
`
`A.
`
` Effective Filing Date of the ‘531 Patent
`
`The ‘531 patent was filed as Appl. No. 09/137,443 on August 20, 1998, and
`
`did not claim priority to any earlier-filed application. For purposes of the Petition
`
`only, the earliest effective filing date of the Challenged Claims is August 20, 1998.
`
`The ‘531 patent issued on August 8, 2000.
`
`
`
`5
`
`

`
`
`B.
`
`Prior Art and Statutory Grounds
`for the Challenge (37 C.F.R. § 42.104(b))
`
`
`1.
`
`U.S. Patent No. 6,008,433 to Stone et al. (“Stone”) (Ex. 1005)
`
`
`
`U.S. Patent No. 6,008,433 (“Stone”) (Ex. 1005) entitled “Osteotomy Wedge
`
`Device, Kit and Methods for Realignment of a Varus Angulated Knee” was filed
`
`on April 23, 1998. Stone is prior art to the ‘531 patent under 35 U.S.C. § 102(e)
`
`because it was filed before the effective filing date (August 20, 1998) of the
`
`‘531 patent but issued after the ‘531 patent. A detailed description of Stone is set
`
`forth in Dr. McMillin’s declaration. (Ex. 1002 at ¶ 49.) Stone was not disclosed
`
`by Applicants nor cited or applied by the Examiner during prosecution of the
`
`‘531 patent.
`
`
`2.
`
`U.S. Patent No. 5,298,254 to
`Prewett et al. (“Prewett”) (Ex. 1006)
`
`
`
`U.S. Patent No. 5,298,254 to Prewett at al. (“Prewett”) (Ex. 1006), entitled
`
`“Shaped, Swollen Demineralized Bone and Its Use in Bone Repair,” issued on
`
`March 29, 1994 and is prior art to the ‘531 patent under 35 U.S.C. § 102(b)
`
`because it issued or published more than one year before the earliest effective
`
`filing date (August 20, 1998) of the ‘531 patent. A detailed description of Prewett
`
`is set forth in Dr. McMillin’s declaration. (Ex. 1002 at ¶ 54.) Prewett was not
`
`disclosed by Applicants nor cited or applied by the Examiner during prosecution of
`
`the ‘531 patent.
`
`
`
`6
`
`

`
`
`3.
`
`U.S. Patent No. 6,066,175 to
`Henderson et al. (“Henderson”) (Ex. 1007)
`
`
`
`U.S. Patent No. 6,066,175 to Henderson et al. (“Henderson”) (Ex. 1007),
`
`entitled “Fusion Stabilization Chamber,” was filed on June 9, 1998. Henderson is
`
`prior art to the ‘531 patent under 35 U.S.C. § 102(e) because it was filed before the
`
`effective filing date (August 20, 1998) of the ‘531 patent but issued after the
`
`‘531 patent. A detailed description of Henderson is set forth in Dr. McMillin’s
`
`declaration. (Ex. 1002 at ¶ 50.) Henderson was not disclosed by Applicants nor
`
`cited or applied by the Examiner during prosecution of the ‘531 patent.
`
`
`4.
`
`U.S. Pat. No. 5,766,251 to Koshino (“Koshino”) (Ex. 1008)
`
`
`
`U.S. Pat. No. 5,766,251 to Koshino (“Koshino”) (Ex. 1008), entitled
`
`“Wedge-Shaped Spacer for Correction of Deformed Extremities,” issued on June
`
`16, 1998. Koshino is prior art under 35 U.S.C. § 102(a) because it issued before
`
`the effective filing date (August 20, 1998) of the ‘531 patent. A detailed
`
`description of Koshino is set forth in Dr. McMillin’s declaration. (Ex. 1002 at
`
`¶ 51.) Koshino was disclosed by Applicants during prosecution of the ‘531 patent.
`
`
`5.
`
`French Patent Application No.
`FR 2,747,034 to Benezech et al. (“Benezech”) (Ex. 1009)1
`
`French Patent Application No. FR 2,747,034 to Benezech et al.
`
`(“Benezech”) (Ex. 1013), entitled “Intersomatic Setting and Fusion System,”
`
`
`1 A certified English translation of Benezech is attached as Ex. 1010.
`
`
`
`7
`
`

`
`published October 10, 1997. Benezech is prior art to the ‘531 patent under
`
`35 U.S.C. § 102(a) because it is a printed publication in the U.S. or a foreign
`
`country before the effective filing date (August 20, 1998) of the ‘531 patent. A
`
`detailed description of Benezech is set forth in Dr. McMillin’s declaration.
`
`(Ex. 1002 at ¶ 52.) Benezech was not disclosed by Applicants nor cited or applied
`
`by the Examiner during prosecution of the ‘531 patent.
`
`
`6.
`
`French Patent Application
`No. FR 2,703,580 to Gilles (“Gilles”) (Ex. 1011)2
`
`French Patent Application No. FR 2,703,580 to Gilles (“Gilles”) (Ex. 1015),
`
`entitled “Cervical Intersomatic Cage”, published on October 14, 1994. Gilles is
`
`prior art to the ‘531 patent under U.S.C. § 102(b) because it is a printed publication
`
`in the U.S. or a foreign country more than one year before the effective filing date
`
`(August 20, 1998) of the ‘531 patent. A detailed description of Gilles is set forth
`
`in Dr. McMillin’s declaration. (Ex. 1002 at ¶ 53.) Gilles was not disclosed by
`
`Applicants nor cited or applied by the Examiner during prosecution of the
`
`‘531 patent.
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`Table 1. Grounds for Inter Partes Review
`
`Ground Claim
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`Statutory Basis and Prior Art
`
`1
`
`105
`
`Anticipation under 35 U.S.C. § 102 over Stone or
`obviousness under 35 U.S.C. § 103 over Stone in view of
`
`
`2 A certified English translation of Gilles is attached as Ex. 1012.
`
`
`
`8
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`Prewett, Henderson and/or Koshino
`
`2
`
`105
`
`Obviousness under 35 U.S.C. § 103 over Benezech in view of
`Gilles
`
`
`These grounds are described in detail in Section VII below, and are supported by
`
`the declaration of Carl McMillin, Ph.D. (Ex. 1002).
`
`
`
`Dr. McMillin received a B.A. in Mechanical Engineering in 1969 from the
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`General Motors Institute of Technology and a Ph.D. from Case Western Reserve
`
`University in macromolecular science and operations research in 1974. From 1983
`
`to 1989, Dr. McMillin was an Associate Professor in the Department of
`
`Biomedical Engineering and Director of the Cardiovascular Laboratory in the
`
`Institute for Biomedical Engineering Research at the University of Akron. From
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`1989 to 1997, he was Senior Scientist, Director of Polymer Laboratory and
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`Director of R&D at AcroMed Corporation, developing orthopedic implant
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`products, primarily for spinal applications. Since 1999, Dr. McMillan has been a
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`member of the adjunct faculty at Cleveland State University teaching courses
`
`including Biomaterials, Artificial Organs and Medical Devices, and Cardiovascular
`
`Complications of Diabetes in the doctoral Applied Biomedical Engineering
`
`Program. He is the recipient of the 2015 C. William Hall lifetime achievement
`
`award from the Society for Biomaterials. As a skilled practitioner in the relevant
`
`field since before 1998, Dr. McMillin is qualified to provide an opinion as to what
`
`a person of ordinary skill in the art would have understood, known or concluded as
`
`
`
`9
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`of August 20, 1998, the earliest-effective filing date of the ‘531 patent.
`
`Accordingly, he is competent to testify in this proceeding.
`
`VI.
`
` SUMMARY OF THE ‘531 PATENT
`
`A.
`
`
`
`Summary of the Patent
`
`The ‘531 patent specification provides a method and apparatus for changing
`
`a spatial relationship between adjacent bones by inserting a wedge member into the
`
`joint between the bones. (Ex. 1001 at 1:48-50.) As depicted below in Figure 1
`
`(which is Figure 2 of the ‘531 patent), the wedge member applies a force to the
`
`adjacent bones as it is moved into the joint, thus changing the spatial relationship
`
`between the bones. (Id. at 1:52-56; 2:42-45; Fig. 2.)
`
`Figure 1: Wedge member inserted into joint
`
`The ‘531 patent specification describes various implantable wedge members.
`
`
`
`
`
`10
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`

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`For example, the wedge member may be porous and/or have passages extending
`
`between the upper and lower surfaces in order to allow bone to grow through it.
`
`(Id. at 10:1-8; Fig. 9.) This can be seen in Figure 2 (which is Figure 9 of the
`
`‘531 patent).
`
`Figure 2: Porous wedge member
`
`
`The ‘531 patent specification further describes that the wedge member may
`
`
`
`be fixedly connected to the bones with screws. (Id. at 7:41-63; Fig. 9.) Once the
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`wedge member is inserted into the joint, it is immediately capable of transmitting
`
`force between the bones. (Id. at 7:36-40.)
`
`The ‘531 patent issued with 129 claims of which independent claim 105 is
`
`the only claim at issue in this Petition.
`
`
`
`11
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`
`B.
`
`Prosecution History of the ‘531 Patent
`
`The application that issued as the ‘531 patent was originally filed with
`
`51 claims. (Ex. 1013 at 54-69.) On August 20, 1999, the Examiner rejected each
`
`of claims as either obvious in view of U.S. Patent No. 5,690,635 (“Michelson”),
`
`obvious over U.S. Patent No. 5, 906, 616 (“Pavlov”) or obvious over Michelson in
`
`view of U.S. Patent No. 5,258,031 (“Salib”). (Ex. 1014 at 2-4.)3
`
`On October 28, 1999, Applicant cancelled claims 1-32 and 40-51 and added
`
`claims 52-173. (Ex. 1015 at 1-38.) Regarding claim 149, which issued as
`
`independent claim 105 (the Challenged Claim), Applicant argued that it was
`
`patentable over the prior art because it required the wedge member to have first
`
`and second major side surfaces (e.g., the top and bottom surfaces of the wedge
`
`member) which intersect to form an edge at a thin end portion and a minor side
`
`surface that extends between the first and second major side surfaces and extends
`
`from the thick end portion to the thin end portion. (Id. at 74.) On February 3,
`
`2000, the Examiner issued a Notice of Allowability. (Ex. 1016 at 1.) The Notice
`
`did not provide the Examiner’s reasons for allowance. (Id.)
`
` Level of Ordinary Skill in the Art
`C.
`
`A person of ordinary skill in the with respect to the ‘531 patent would have a
`
`
`3 Dr. McMillin describes Michelson, Pavlov and Salib in his declaration. (Ex.
`
`1002 at ¶¶ 37, 38 and 48.)
`
`12
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`Bachelor’s or equivalent degree in Mechanical Engineering or a related discipline
`
`(e.g. biomechanics or biomedical engineering), and at least five years of
`
`experience, or a Ph.D. and at least two years of experience. (Ex. 1002 at ¶ 56.)
`
`The experience would consist of a) designing, developing, evaluating and/or using
`
`prosthetic devices, b) anatomy, physiology and biology of soft and calcified tissues
`
`including bone healing and fusion, and c) biomechanical and functional loading of
`
`orthopedic implants. (Id.) Alternatively, a person of ordinary skill would be a
`
`Doctor of Medicine who has completed an accredited residency program in
`
`orthopedic surgery followed by at least two years in active practice specializing in
`
`orthopedic surgery. (Id. at ¶ 55.)
`
`
`
` Claim Construction (37 C.F.R. § 42.104(b)(3)) D.
`
`Petitioners do not concede that the scope of the terms construed or other
`
`terms in the claims are reasonably certain to one of ordinary skill in the art. See
`
`generally Nautilus, Inc. v. Bioig Instruments, Inc., 134 S.Ct. 2120 (2014). Rather,
`
`Petitioners believe that many of the terms are indefinite and reserve all rights to
`
`argue indefiniteness in the related litigation.
`
`A patent claim term in inter partes review is to be given the “broadest
`
`reasonable construction in light of the specification” as commonly understood by
`
`those of ordinary skill in the art. 37 C.F.R. § 42.100(b). The terms are given a
`
`broad interpretation except where defined otherwise in the specification. In re
`
`
`
`13
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`

`
`ICON Health & Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007). Consistent
`
`with this standard, and without conceding that these terms should be construed the
`
`same way in a district court proceeding, Petitioners provide proposed constructions
`
`of certain claim terms below for the purpose of this Petition only.
`
`
`1.
`
`“movable into the joint between first and second bones”
`
`
`
`The Challenged Claim is directed to an apparatus comprising a wedge
`
`member. The body of the claim contains the recitation that the wedge member is
`
`“movable into the joint between the first and second bones.” In its December 16,
`
`2015 Decision Instituting Inter Partes Review of IPR2015-01339, the Board held
`
`that the similar term “configured and dimensioned for insertion into [a/the] joint”
`
`in apparatus claims 1 and 14 of the related ‘385 patent “are intended-use
`
`limitations or functional limitations that are not material to patentability because
`
`they do not structurally distinguish the claimed apparatus from Stone.” (Ex. 1018
`
`at 15-16.) The term “movable into a joint between first and second bones” is
`
`likewise an intended-use or functional limitation that is not material to patentability
`
`over prior art that discloses the structural limitations of the claim.
`
`
`
`It is black-letter patent law that “apparatus claims cover what a device is, not
`
`what a device does.” M.P.E.P § 2114(II) (quoting Hewlett-Packard Co.v.Bausch
`
`& Lomb Inc., 909 F.2d 1464, 1469 (Fed. Cir. 1990).) See also Superior Indus.,
`
`Inc. v. Masaba, Inc., 553 F. App’x 986, 991 (Fed. Cir. 2014) (Rader, concurring).
`
`
`
`14
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`

`
`Therefore, “[a] claim containing a ‘recitation with respect to the manner in which a
`
`claimed apparatus is intended to be employed does not differentiate the claimed
`
`apparatus from a prior art apparatus’ if the prior art apparatus teaches all the
`
`structural limitations of the claim.” M.P.E.P § 2114(II) (quoting Ex parte Masham,
`
`2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).) See also In re Schreiber, 128 F.3d
`
`1473, 1477 (Fed. Cir. 1997) (“[T]he recitation of a new intended use for an old
`
`product does not make a claim to that old product patentable.”) Thus, the
`
`recitations of intended use or function in the Challenged Claim does not render it
`
`patentably distinct over a prior art apparatus that discloses all of the structural
`
`limitations of the claim.
`
`VII.
`
` DETAILED EXPLANATION (37 C.F.R. §§ 42.104(B)(4)-(5))
`
`A.
`
` General State of the Art
`
`The ‘531 patent is generally directed to an implantable wedge-shaped device
`
`used for changing the spatial relationship between bones in the human body.
`
`(Ex. 1002 at ¶ 24.) A person of ordinary skill in the art would have understood that
`
`the field of such devices would include at least devices used in osteotomy and
`
`spinal fusion procedures. (Id.)
`
`Osteotomy is the surgical practice in which a bone is cut to shorten,
`
`lengthen, or to change its alignment (e.g. to correct the shape of deformed bones).
`
`(Ex. 1002 at ¶ 25.) To change the alignment, the surgeon can either cut out and
`
`
`
`15
`
`

`
`remove a wedged piece of bone and close the opening (a closing wedge osteotomy)
`
`or can insert a wedge shaped piece of bone or implant into the opening (an opening
`
`wedge osteotomy). (Id.) In a closing wedge osteotomy, the resulting site has bone
`
`on bone contact and can fuse directly. (Id.) In an opening wedge osteotomy, the
`
`wedge shaped implant can be filled with bone marrow, bone chips or other bone
`
`inducing materials to promote bone formation and fusion. (Id.) This procedure
`
`was well-known to a person of ordinary skill in the art as of August 20, 1998.
`
`(Id.)
`
`A common form of spinal fusion involves the fusion of two adjacent
`
`vertebra, a procedure that is often done to restore the normal curvature of the spine.
`
`(Id. at ¶ 30.)
`
`Figure 3: Curvature of the spine
`
`The normal curvature of the spine consists of lordosis (segments creating a
`
`
`
`
`
`16
`
`

`
`backward-leaning curve) in the cervical region, kyphosis (segments creating a
`
`forward-leaning curve) in the thoracic region and lordosis again in the lumbar
`
`region and is generated by both wedge-shaped vertebral bodies and wedge-shaped
`
`spinal discs. (Id. at ¶ 27.)
`
`As of August 20, 1998, the use of wedge-shaped spinal implants to stabilize
`
`and fuse vertebrae was common practice. (Id. at ¶ 32.) As early as the 1950s,
`
`decompression – the removal of the intervertebral disc located between adjacent
`
`vertebrae – together with the implantation of a bone graft in the resulting space had
`
`been established as a standard method of accomplishing stabilization and fusion.
`
`(Id.) Between 1990 and 1998, over one million spinal fusions were performed in
`
`hospitals throughout the U.S. (Id. at ¶ 33.) At this time, spinal implants designed
`
`to fuse two vertebrae typically contained one or more passages for insertion of
`
`bone graft material through which bone growth could occur. (Id. at ¶ 36.) The
`
`illustration below shows a wedge-shaped vertical ring implant with two openings
`
`for bone