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. 6,423,063 to Bonutti
`Appl. No. 09/569,020 filed May 11, 2000
`Issued October July 23, 2002
`
`IPR Trial No.
`
`TBD
`
`PETITION FOR INTER PARTES
`REVIEW OF U.S. PATENT NO. 6,423,063
`PURSUANT TO 35 U.S.C. § 312 AND 37 C.F.R. § 42.108
`
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`
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`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)) ..........................3
`
`Service Information (37 C.F.R. § 42.8(b)(4)) ....................................4
`
`III.
`
`
`
`Fee Payment Authorization (37 C.F.R. § 42.103) ........................................4
`
`IV.
`
` Grounds for Standing (37 C.F.R. § 42.104(a)) ............................................4
`
`V.
`
`
`
`Identification of Challenge (37 C.F.R. § 42.104(b)) ....................................4
`
`A.
`
`
`
`B.
`
`
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`Effective Filing Date of the ‘063 Patent ............................................5
`
`Prior Art and Statutory Grounds for the Challenge (37 C.F.R.
`§ 42.104(b)).....................................................................................5
`
`1.
`
`
`
`2.
`
`
`
`3.
`
`
`
`4.
`
`
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`5.
`
`
`
`Tan S.B. et al., “A Modified Technique of Anterior Lumbar
`Fusion with Femoral Cortical Allograft,” J. Orthopaedic
`Surgical Techniques, 5(3): 83-93 (1990) (“Tan”) (Ex. 1009) ....5
`
`U.S. Patent No. 6,511,509 to Ford et al. (“Ford”) (Ex. 1005)....6
`
`U.S. Patent No. 5,298,254 to Prewett et al. (“Prewett”) (Ex.
`1006) .....................................................................................7
`
`U.S. Patent No. 5,725,531 to Shapiro (“Shapiro”) (Ex. 1007) ...7
`
`U.S. Patent No. 6,066,175 to Henderson et al. (“Henderson”)
`(Ex. 1008)..............................................................................8
`
`VI.
`
` Summary of the ‘063 Patent.......................................................................9
`
`A.
`
`
`
`B.
`
`
`
`C.
`
`
`
`D.
`
`
`
`Summary of the Patent .....................................................................9
`
`Prosecution History of the Challenged Claim .................................. 12
`
`Level of Ordinary Skill in the Art ................................................... 13
`
`Claim Construction (37 C.F.R. § 42.104(b)(3)) ............................... 14
`
`1.
`
`
`
`“changing a spatial relationship between first and second bones
`which are interconnected at a joint in a patient’s body” .......... 14
`
`2.
`
`
`
`“abrading” ........................................................................... 16
`
`
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`i
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`

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`
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`3.
`
`
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`“biodegradable material” ...................................................... 16
`
`VII.
`
` Detailed Explanation (37 CFR 42.104(b)(4)-(5))....................................... 17
`
`A.
`
` General State of the Art.................................................................. 17
`
`B.
`
`
`
`Ground 1 – The Challenged Claim is Anticipated by Tan ................ 21
`
`C.
`
` Ground 2 – The Challenged Claim is Obvious over Ford in View of
`Tan and/or Shapiro ........................................................................ 28
`
`D.
`
` Ground 3 – The Challenged Claim is Obvious over Prewett in View of
`Tan and/or Shapiro ........................................................................ 37
`
`E.
`
`
`
`F.
`
`
`
`Ground 4 – The Challenged Claim is Obvious over Henderson in
`View of Tan and/or Shapiro ........................................................... 43
`
`Secondary Considerations of Nonobviousness Cannot Overcome the
`Strong Prima Facie Showing of Obviousness ................................. 52
`
`VIII.
`
` Conclusion .............................................................................................. 53
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`
`
`
`
`ii
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`

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`
`
`Cases
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Biomet Inc. v. Bonutti Skeletal Innovations LLC,
`No. 13-176-JVB (N.D. In.) ....................................................................... 2, 16
`
`Bonutti Skeletal Innovations, LLC v.
`DePuy Synthes Sales, Inc. and DePuy Synthes Products, LLC,
`No. 14-14680-IT (D. Mass.) ................................................................2, 15, 17
`
`Bonutti Skeletal Innovations LLC v. Globus Medical Inc.,
`No. 14-6650-WB (E.D. Pa.)............................................................................ 2
`
`DyStar Textilfarben GmbH &
`Co. Deutschland KG v. C.H. Patrick Co.,
`464 F.3d 1356 (Fed. Cir. 2006) .......................................................... 33, 40, 48
`
`In re ICON Health & Fitness, Inc.,
`496 F.3d 1374 (Fed. Cir. 2007) ..................................................................... 14
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) .......................................................................... 33, 40, 48
`
`Nautilus, Inc. v. Bioig Instruments, Inc.,
`134 S.Ct. 2120 (2014) .................................................................................. 14
`
`Ohio Willow Wood Co. v. Alps S., LLC,
`735 F.3d 1333 (Fed. Cir. 2013) ..................................................................... 52
`
`Q.I. Press Controls, B.V. v. Lee,
`752 F.3d 1371 (Fed. Cir. 2014) ..................................................................... 52
`
`Statutes
`
`35 U.S.C. § 102 et seq ................................................................................. 6, 7, 8
`
`35 U.S.C. § 103 .............................................................................................. 1, 8
`
`35 U.S.C. § 120 .................................................................................................. 5
`
`
`
`iii
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`

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`
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`35 U.S.C. § 311 et seq. ........................................................................................ 1
`
`35 U.S.C. § 314 .................................................................................................. 1
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`Other Authorities
`
`37 C.F.R. § 42.1 et seq. ....................................................................................... 1
`
`37 C.F.R. § 42.8 et seq ................................................................................ 2, 3, 4
`
`37 C.F.R. § 42.10(b) ........................................................................................... 4
`
`37 C.F.R. § 42.15(a)............................................................................................ 4
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`37 C.F.R. §§ 42.22(a)(1) and 42.104(b)(1)-(2)...................................................... 4
`
`37 C.F.R. § 42.100(b)........................................................................................ 14
`
`37 C.F.R. § 42.103 .............................................................................................. 4
`
`37 C.F.R. § 42.104 et seq ...........................................................................4, 5, 14
`
`37 C.F.R. § 42.108 .............................................................................................. 1
`
`37 CFR 42.104(b)(4)-(5) ................................................................................... 17
`
`
`
`iv
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`

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`
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`EXHIBIT LIST
`
`Exhibit No.
`
`Description
`
`Short Reference
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
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`1011
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`1012
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`1013
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`1014
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`1015
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`1016
`
`1017
`
`1018
`
`1019
`
`
`
`U.S. Patent No. 6,423,063
`
`the ‘063 patent
`
`Declaration of Dr. Allen L. Carl
`
`Carl Decl.
`
`Curriculum Vitae of Dr. Allen L. Carl
`
`Carl CV
`
`List of Prior Art and Materials
`Considered by Dr. Allen L. Carl
`
`Materials Considered
`
`U.S. Patent No. 6,511,509
`
`U.S. Patent No. 5,298,254
`
`U.S. Patent No. 5,725,531
`
`U.S. Patent No. 6,066,175
`
`Tan S.B. et al., “A Modified Technique
`of Anterior Lumbar Fusion with
`Femoral Cortical Allograft,” J.
`Orthopaedic Surgical Techniques, 5(3):
`83-93 (1990)
`
`U.S. Patent Application No. 09/569,020
`
`Preliminary Amendment, dated May
`10, 2000
`
`Office Action, dated Sept. 13, 2000
`
`Amendment, dated Feb. 9, 2001
`
`Office Action, dated June 18, 2001
`
`Supplemental Amendment, dated
`December 13, 2001
`
`Appeal Brief, dated Feb. 12, 2002
`
`Notice of Allowability, dated Mar. 13,
`2002
`
`Petition for Inter Partes Review of U.S.
`Patent No. 6,423,063, IPR2015-01345
`
`Bonutti Skeletal Innovations LLC’s
`Patent Owner Preliminary Response,
`IPR2015-01345
`
`v
`
`Ford
`
`Prewett
`
`Shapiro
`
`Henderson
`
`Tan
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`
`
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`
`

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`
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`Bonutti Skeletal’s Preliminary
`Disclosure of Asserted Claims and
`Infringement Contentions, Exhibit B-1
`
`Infringement Contentions
`
`MERRIAM WEBSTER’S MEDICAL DESK
`DICTIONARY (1996)
`
`WEBSTER’S
`
`Biomet, Inc. v. Bionutti Skeletal
`Innovations LLC, No. 3:13-cv-176
`(D.I. 69) (N.D. Ind. 2014)
`
`
`
`Declaration of Martha Fishel
`
`Fishel Decl.
`
`Declaration of Dr. Hassan Serhan
`
`Serhan Decl.
`
`FIGURES AND TABLES
`
`Figure No.
`
`Description
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
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`11
`
`12
`
`13
`
`14
`
`Figure 2 of the ‘063 patent
`
`Figure 12 of the ‘063 patent
`
`Curvature of the spine
`
`Wedge-shaped intervertebral implant (annotated)
`
`Illustration of cross section of disc and vertebrae
`
`Figure 5 of Tan
`
`Figure 6 of Tan
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`Wedge-shaped allograph of Tan
`
`Portion of Fig. 8 of Tan
`
`Figure 1A of Ford
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`Figure 10 of Shapiro
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`Figure 6 of Prewett
`
`Figure 8 of Henderson
`
`Figure 15 of Henderson
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`Table No.
`
`Description
`
`1
`
`2
`
`Grounds for Inter Partes Review
`
`Ground 1 – The Challenged Claim is Anticipated by Tan
`
`vi
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`

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`
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`3
`
`4
`
`5
`
`Ground 2 – The Challenged Claim is Obvious Over Ford in View
`of Tan and/or Shapiro
`
`Ground 3 – The Challenged Claim is Obvious Over Prewett in
`View of Tan and/or Shapiro
`
`Ground 4 – The Challenged Claim is Obvious Over Henderson in
`View of Tan and/or Shapiro
`
`vii
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`

`
`
`
`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. 6,423,063 (“the ‘063 patent”), attached hereto as Ex. 1001. Petitioners
`
`respectfully submit that Independent Claim 34 (the “Challenged Claim”) is
`
`unpatentable as obvious under 35 U.S.C. § 103 in view of the prior art discussed
`
`herein.
`
`The Challenged Claim is directed to a method of using a wedge in a
`
`patient’s body to move one bone relative to another. There was nothing novel
`
`about the Challenged Claim as of August 20, 1998, the earliest effective filing date
`
`of the ‘063 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,
`
`spine surgeons had been using wedge-shaped implants for decades to fuse adjacent
`
`vertebral bones and restore lordosis in patients. The only additional elements of
`
`the Challenged Claim are that the wedge be made of a biodegradable material and
`
`that the bone surfaces be abraded before inserting the wedge. These elements were
`
`standard practice in the spinal implant art as of 1998.
`
`Accordingly, Petitioners respectfully request that the Board institute an inter
`
`partes review of the ‘063 patent pursuant to 35 U.S.C. § 314 and 37 C.F.R. §
`
`
`
`1
`
`

`
`
`
`42.108.
`
`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, LLC, No. 14-14680-IT (D. Mass.) (“the Pending
`
`Litigation”). The litigation involves six patents: the ‘063 patent, U.S. Patent No.
`
`6,099,531 (“the ‘531 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”). Claim 34 of the ‘063 patent is 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 ‘063 patent.
`
`
`
`2
`
`

`
`
`
`Petitioners are concurrently filing four additional petitions for inter partes
`
`review that will address (i) certain claims of the ‘531 patent, (ii) certain claims of
`
`the ‘385 patent, (iii) certain claims of the ‘066 patent, and (iv) certain claims of the
`
`‘363 patent. The ‘531 patent and the ‘385 patent are related to the ‘063 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 IPR2015-01344, which included the Challenged Claim 34 of
`
`the ‘063 patent. None of the prior art provided in this Petition was presented to the
`
`Board in IPR2015-01344.
`
`
`
` Lead and Back-up Counsel (37 C.F.R. § 42.8(b)(3)) C.
`
`Petitioner designates 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
`
`
`
`3
`
`

`
`
`
` 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
`
`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 ‘063 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 Claim and request that
`
`
`
`4
`
`

`
`
`
`the Challenged Claim be cancelled.
`
`A.
`
` Effective Filing Date of the ‘063 Patent
`
`The ‘063 patent was filed as Appl. No. 09/569,020 (“the ‘020 application”)
`
`on May 11, 2000. It is a continuation of Appl. No. 09/137,433, (“the
`
`‘433 application”) filed on August 20, 1998, now U.S. Patent No. 6,099,531. The
`
`Patent Office never determined that the ‘020 application is entitled to the priority
`
`benefit, under 35 U.S.C. § 120, to the earlier-filed ‘433 application. For purposes
`
`of the petition only, the earliest effective filing date of the Challenged Claim is
`
`August 20, 1998.
`
`
`B.
`
`Prior Art and Statutory Grounds
`for the Challenge (37 C.F.R. § 42.104(b))
`
`
`1.
`
`Tan S.B. et al., “A Modified Technique of Anterior Lumbar
`Fusion with Femoral Cortical Allograft,” J. Orthopaedic
`Surgical Techniques, 5(3): 83-93 (1990) (“Tan”) (Ex. 1009)
`
`
`
`Tan S.B. et al., “A Modified Technique of Anterior Lumbar Fusion with
`
`Femoral Cortical Allograft,” J. Orthopaedic Surgical Techniques, 5(3): 83-93
`
`(1990) (“Tan”) (Ex. 1009) was published in The Journal of Orthopaedic Surgical
`
`Techniques, Vol. 5, No. 3, in 1990. As demonstrated by the certification of Martha
`
`Fishel of the National Library of Medicine in Bethesda, Maryland, Tan is an
`
`ancient and authentic document under Rules 803(16) and 901(b)(8) of the Federal
`
`Rules of Evidence, and its 1990 publication date and April 16, 1991 date stamp
`
`from the National Library of Medicine are therefore not hearsay. (Ex. 1023.)
`
`
`
`5
`
`

`
`
`
`Furthermore, Ms. Fishel’s declaration demonstrates that the National Library of
`
`Medicine received Tan on or about April 16, 1991. (Id.) As further demonstrated
`
`by the declaration of Dr. Hassan Serhan, Tan was distributed to individual and
`
`institutional subscribers (libraries, universities, etc.) of the Journal of Orthopaedic
`
`Surgical Techniques all over the world shortly after it published in 1990. (Ex.
`
`1024.) Within a few weeks or months of its publication in 1990, Tan was also
`
`findable and available to interested members of the public as well as persons with a
`
`professional interest in the subject matter in many libraries in the United States and
`
`the rest of the world, including the National Library of Medicine. (Id.) Tan is
`
`therefore prior art to the ‘063 patent under 35 U.S.C. § 102(b) because it is a
`
`printed publication more than one year before the earliest effective filing date
`
`(August 20, 1998) of the ‘063 patent. A detailed description of Tan is set forth in
`
`Dr. Carl’s declaration. (Ex. 1002 at ¶¶ 41-44.) Tan was not disclosed by
`
`Applicants nor cited or applied by the Examiner during prosecution of the
`
`‘063 patent.
`
`
`2.
`
`U.S. Patent No. 6,511,509 to Ford et al. (“Ford”) (Ex. 1005)
`
`
`
`U.S. Patent No. 6,511,509 to Ford et al. (“Ford”) (Ex. 1005), entitled
`
`“Textured Bone Allograft, Method of Making and Using Same,” was filed on
`
`May 7, 1998 and originates from provisional application No. 60/062,823, filed on
`
`October 20, 1997. Ford is prior art to the ‘063 patent under 35 U.S.C. § 102(e)
`
`
`
`6
`
`

`
`
`
`because it was filed before the effective filing date (August 20, 1998) of the
`
`‘063 patent but issued after the ‘063 patent. A detailed description of Ford is set
`
`forth in Dr. Carl’s declaration. (Ex. 1002 at ¶¶ 45-48.) Ford was not disclosed by
`
`Applicants nor cited or applied by the Examiner during prosecution of the
`
`‘063 patent.
`
`
`3.
`
`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 ‘063 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 ‘063 patent. A detailed description of Prewett
`
`is set forth in Dr. Carl’s declaration. (Ex. 1002 at ¶¶ 49-50.) Prewett was not
`
`disclosed by Applicants nor cited or applied by the Examiner during prosecution of
`
`the ‘063 patent.
`
`
`4.
`
`U.S. Patent No. 5,725,531 to Shapiro (“Shapiro”) (Ex. 1007)
`
`
`
`U.S. Patent No. 5,725,531 to Shapiro (“Shapiro”) (Ex. 1007), entitled
`
`“Reaming Device,” issued on March 10, 1998. Shapiro is prior art under
`
`35 U.S.C. § 102(a) because it issued before the earliest effective filing date
`
`(August 20, 1998) of the ‘063 patent. A detailed description of Shapiro is set forth
`
`in Dr. Carl’s declaration. (Ex. 1002 at ¶¶ 51-53.) Shapiro was not disclosed by
`
`
`
`7
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`

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`
`
`Applicants nor cited or applied by the Examiner during prosecution of the
`
`‘063 patent.
`
`
`5.
`
`U.S. Patent No. 6,066,175 to
`Henderson et al. (“Henderson”) (Ex. 1008)
`
`
`
`U.S. Patent No. 6,066,175 to Henderson et al. (“Henderson”) (Ex. 1008),
`
`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
`
`earliest 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. Carl’s
`
`declaration. (Ex. 1002 at ¶¶ 54-57.) Henderson was applied by the Examiner
`
`during prosecution of the ‘063 patent.
`
`
`
`The challenged claim is unpatentable based upon the following grounds:
`
`Table 1. Grounds for Inter Partes Review
`
`Ground Claim
`
`Statutory Basis and Prior Art
`
`1
`
`2
`
`3
`
`4
`
`34
`
`34
`
`34
`
`34
`
`Anticipation under 35 U.S.C. § 102 over Tan.
`
`Obviousness under 35 U.S.C. § 103 over Ford in view of Tan
`and/or Shapiro.
`
`Obviousness under 35 U.S.C. § 103 over Prewitt in view of
`Tan and/or Shapiro.
`
`Obviousness under 35 U.S.C. § 103 over Henderson in view of
`Tan and/or Shapiro.
`
`
`These grounds are described in detail in Section VII below, and are supported by
`
`the declaration of Allen L. Carl, M.D. (Ex. 1002).
`
`
`
`8
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`

`
`
`
`
`
`Dr. Carl is a Professor of Orthopedic Surgery at Albany Medical College
`
`and was appointed to this position in 1997. Dr. Carl has been Vice-Chairman of
`
`Orthopedic Surgery since 1993 at Albany Medical College and was a Resident of
`
`Orthopedic Surgery at State University of New York at Stony Brook from 1980 to
`
`1981 and Orthopedic Surgery at University Medical Center at Bellevue Hospital
`
`from 1981 to 1985. As a skilled practitioner in the relevant field since before
`
`1998, Dr. Carl is qualified to provide an opinion as to what a person of
`
`ordinary skill in the art would have understood, known or concluded as of
`
`August 20, 1998—the earliest effective filing date of the ‘063 patent. Accordingly,
`
`he is competent to testify in this proceeding.
`
`VI.
`
` SUMMARY OF THE ‘063 PATENT
`
`A.
`
`
`
`Summary of the Patent
`
`The ‘063 patent specification provides a method for changing a spatial
`
`relationship between adjacent bones by inserting a wedge member into the joint
`
`between the bones. (Ex. 1001 at 1:53-59.) As depicted below in Figure 1 (which
`
`is Figure 2 of the ‘063 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 1:59-61; 2:46-49; Fig. 2.)
`
`
`
`9
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`

`
`
`
`Figure 1: Wedge member inserted into joint
`
`
`The ‘063 patent specification describes various implantable wedge members.
`
`For example, the wedge member may have a sharp leading edge as above or, a
`
`blunt thin end as depicted below in Figure 2 (which is Figure 12 of the
`
`‘063 patent). (Id. at 13:60-66; Fig. 12.) The specification further describes that
`
`“the wedge member may be formed of human or animal bone, stainless steel,
`
`tantalum, a porous ceramic, or a polymeric material. If desired, the wedge member
`
`may be formed of a biodegradable material.” (Id. at 7:35-39.)
`
`
`
`10
`
`

`
`
`
`Figure 2: Example of a blunt wedge member
`
`
`The ‘063 patent specification also states that “under certain circumstances []
`
`it may be necessary to abrade or otherwise cut . . . the outer layers of hard cortical
`
`bone to prepare the joint for insertion of the wedge member.” (Id. at 8:50-54.)
`
`The ‘063 patent issued with 35 claims. The Challenged Claim is directed to
`
`“[a] method comprising the steps of changing a spatial relationship between first
`
`and second bones which are interconnected at a joint in a patient’s body, said step
`
`of changing the spatial relationship between the first and second bones includes
`
`abrading a portion of the first bone at the joint between the first and second bones,
`
`abrading a portion of the second bone at the joint between the first and second
`
`bones, providing a wedge member which is at least partially formed of
`
`biodegradable material, and moving the wedge member which is at least partially
`
`formed of biodegradable material into the joint between the first and second bones,
`
`
`
`11
`
`

`
`
`
`said step of moving the wedge member which is at least partially formed of
`
`biodegradable material into the joint between the first and second bones includes
`
`engaging the abraded portion of the first bone with the wedge member and
`
`engaging the abraded portion of the second bone with the wedge member.” (Id. at
`
`claim 34.)
`
`
`B.
`
`Prosecution History of the Challenged Claim
`
`
`
`The application that issued as the ‘063 patent was originally filed with
`
`51 claims. (Ex. 1010 at 54-69.) Applicant cancelled claims 2-51 in a preliminary
`
`amendment and added new claims 52-62. (Ex. 1011 at 2-5.)
`
`
`
`On September 13, 2000, the Examiner rejected all pending claims as being
`
`obvious over U.S. Pat. No. 5,116,374 (“Stone”), stating that “Stone disclose a
`
`biodegradable wedge . . . .“ (Ex. 1012 at 2-3.) On February 9, 2001, Applicant
`
`cancelled all pending claims and added new claims 63-112. (Ex. 1013 at 1-17.)
`
`
`
`On June 18, 2001, the Examiner rejected a number of claims, including
`
`claim 111 which later issued as the Challenged Claim, as obvious over Henderson.
`
`(Ex. 1014 at 4-6.) As a result of a previous telephone examiner interview with
`
`Applicant, the Examiner withdrew claims 65, 67, 77, 81, 88, 89, 106-110 and 112
`
`from consideration as being drawn to a non-elected invention. (Id. at 3.) The
`
`Examiner allowed claims 90-98. (Id. at 1.) The Examiner also identified nine
`
`patently distinct species and required Applicant to elect a single disclosed species
`
`
`
`12
`
`

`
`
`
`for prosecution on the merits. (Id. at 2-3.)
`
`
`
`On December 13, 2001, Applicant filed a supplemental amendment, arguing
`
`that each of the pending claims were patentable. (Ex. 1015 at 1-12.) Regarding
`
`claim 111, Applicant argued that Henderson “does not disclose abrading a portion
`
`of a bone in the manner set forth in claim 111.” (Id. at 11.)
`
`
`
`On February 12, 2002, Applicant filed an appeal brief, arguing with respect
`
`to claim 111 that Henderson does not disclose either changing the spatial
`
`relationship between first and second bones or abrading first and second bones
`
`before moving a wedge member into a joint. (Ex. 1016 at 22-23.)
`
`
`
`On March 13, 2002, the Examiner issued a Notice of Allowability for claims
`
`63-74, 76-87, 90-98, 111 and 112. (Ex. 1017 at 1-2.) 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 art with respect to the ‘063 patent 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. A person having ordinary skill in the art would be familiar
`
`with orthopedic implant systems, specifically spinal fusion systems, and the
`
`surgical methods used to implant such systems in patients.
`
`
`
`13
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`

`
`
`
`
`
` 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
`
`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.
`
`
`1.
`
`“changing a spatial relationship between first and second
`bones which are interconnected at a joint in a patient’s
`body”
`
`Under the broadest reasonable construction, the Challenged Claim is not
`
`limited to any specific means of changing the spatial relationship between first and
`
`second bones. None of the sub-parts of the recited “step of changing the spatial
`
`relationship between first and second bones” include such a means. Furthermore,
`
`
`
`14
`
`

`
`
`
`the terms “comprising” and “including” are inclusive and open-ended and do not
`
`exclude additional, unrecited elements or method steps. Thus, for the purposes of
`
`this Petition, the method of the Challenged Claim includes common surgical
`
`techniques to move adjacent bones apart prior to moving the wedge member into
`
`the joint.
`
`The broadest reasonable construction of this term also includes restoration of
`
`a desired anatomical relationship between vertebrae such as the restoration of
`
`lordosis. This is evidenced by the Patent Owner’s allegation in the Pending
`
`Litigation that the accused ACF Spinal Spacer product meets the limitation
`
`because it is designed to “restore lordosis” and “help restore anatomic alignment.”
`
`(Ex. 1020 at 14-16.) Furthermore, in the related inter partes review of the
`
`‘063 patent, IPR2015-01345, the Patent Owner did not dispute that a spinal
`
`implant device that “restores a desired anatomical relationship from a degenerated
`
`condition[] between first and second bones (i.e., vertebrae) at an intervertebral
`
`joint in a patient’s body” constitutes “changing a spatial relationship.” (Compare
`
`Ex. 1018 at 12 (petitioner asserting above-quoted construction) with Ex. 1019 at 6-
`
`8 (Patent Owner’s response not disputing quoted construction).) Accordingly,
`
`under the broadest reasonable construction standard and for the purposes of this
`
`Petition only, restoration of a desired anatomical relationship from between
`
`vertebrae such as the restoration of lordosis constitutes “changing a spatial
`
`
`
`15
`
`

`
`
`
`relationship between first and second bones which are interconnected at a joint in a
`
`patient’s body.”
`
`
`2.
`
`“abrading”
`
`The broadest reasonable construction of “abrading” includes “irritat[ing] or
`
`roughen[ing] by rubbing.” MERRIAM WEBSTER’S MEDICAL DESK DICTIONARY
`
`(1996) (Ex. 1021 at 3). This is supported by the ‘063 patent specification, which
`
`states that “it may be necessary to abrade or otherwise cut the outer side surfaces
`
`88 and 90 of the outer layers 76 and 78 of hard cortical bone to prepare the joint 34
`
`for insertion of the wedge member 44.” (Ex. 1001 at 8:50-54.) Nothing in the
`
`prosecution history of the ‘063 patent suggest a departure from this ordinary
`
`meaning.
`
`
`3.
`
`“biodegradable material”
`
`In the related litigation Biomet Inc. v. Bonutti Skeletal Innovations, the
`
`Patent Owner stipulated that “biodegradable” in claim 34 of the ‘ 063 patent means
`
`“a substance that can be chemically degraded or decomposed by the body.”
`
`(Ex. 1022 at 57.) For the purpose of this Petition, the Patent Owner’s construction
`
`should be considered the broadest reasonable construction.
`
`The specification of the ‘063 patent is compatible with the broadest
`
`reasonable construction. It states that “[t]he wedge member 44 may be formed of
`
`any one of many different known materials which are compatible with a 35
`
`
`
`16
`
`

`
`
`
`patient’s body. . . . If desired, the wedge member may be formed of a
`
`biodegradable material.” (Ex. 1001 at 7:34-39.) Nothing in the prosecution
`
`history of the ‘063 patent suggest a different meaning.
`
`Bone allografts, i.e., bones taken from one person (typically a cadaver) and
`
`implanted in another person, degrade over time in the body. (Ex. 1002 at ¶ 22.)
`
`Thus, bone allografts are biodegradable material for the purpose