throbber
Trials@uspto.gov
`571-272-7822
`
`Paper 73
`Date: August 26, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SURGALIGN SPINE TECHNOLOGIES, INC.,
`Petitioner,1
`v.
`LIFENET HEALTH,
`Patent Owner.
`
`IPR2019-00569
`Patent 6,458,158 B1
`
`
`
`
`
`
`
`
`
`Before GEORGE R. HOSKINS, TIMOTHY J. GOODSON, and
`CHRISTOPHER C. KENNEDY, Administrative Patent Judges.
`GOODSON, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`Dismissing Petitioner’s Motion to Exclude
`Denying Patent Owner’s Motion to Exclude
`35 U.S.C. § 318(a)
`
`
`
`
`
`1 Petitioner recently filed Updated Mandatory Notices indicating that its
`name has changed from RTI Surgical, Inc. to Surgalign Spine Technologies,
`Inc. See Paper 72.
`
`
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`
`INTRODUCTION
`I.
`A. Background and Summary
`Petitioner filed a Petition (Paper 2, “Pet.”) requesting inter partes
`review of claims 1–15 of U.S. Patent No. 6,458,158 B1 (Ex. 1002, “the ’158
`patent”). Patent Owner filed a Preliminary Response. Paper 10. We
`instituted an inter partes review on all claims and all grounds asserted in the
`Petition. See Paper 15 (“Dec. on Inst.”).
`After institution of trial, Patent Owner filed a Patent Owner Response.
`Paper 31 (“PO Resp.”).2 Petitioner filed a Reply. Paper 42 (“Pet. Reply”).
`Patent Owner filed a Sur-Reply. Paper 57 (“Sur-Reply”). We held a hearing
`on June 2, 2020, a transcript of which is included in the record. See Paper
`70 (“Tr.”).
`We have authority under 35 U.S.C. § 6. Petitioner bears the burden of
`proving unpatentability of the challenged claims, and the burden of
`persuasion never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l
`Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner
`must prove unpatentability by a preponderance of the evidence. See
`35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). This Final Written Decision is
`issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`For the reasons discussed below, we determine that Petitioner has not
`shown by a preponderance of the evidence that claims 1–15 of the ’158
`patent are unpatentable.
`
`
`2 A public, redacted version of the Patent Owner Response was filed as
`Paper 30.
`
`2
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`B. Real Parties in Interest
`The parties list only themselves as real parties in interest. See Pet. 3;
`Paper 4, 1.
`C. Related Matters
`Patent Owner asserted the ’158 patent against Petitioner in LifeNet
`Health v. RTI Surgical, Inc., No. 1:18-cv-00146-MW-GRJ (N.D. Fla.), filed
`June 27, 2018. See Pet. 3; Paper 4, 1. The parties also list another
`proceeding at the Board as a related matter: Case IPR2019-00570, which
`challenges U.S. Patent No. 8,182,532. See Pet. 3; Paper 4, 1.
`D. The ’158 Patent
`The ’158 patent relates to a composite bone graft for spinal fusion.
`Ex. 1002, 1:10–16. Spinal fusion is a surgical procedure in which a patient’s
`intervertebral disc is removed and replaced with an implant to fill the void
`between adjacent vertebrae. See Ex. 2001 ¶ 21. After the implantation
`procedure, the natural healing process of bones causes the vertebrae to fuse
`together over time. Id.; Ex. 1016 ¶¶ 21–23. Implants for spinal fusion can
`be made from various materials, including bone obtained from the patient,
`which is referred to as autologous bone, or bone obtained from a human
`donor, which is allogenic bone. See Ex. 1016 ¶ 25; Ex. 2001 ¶ 26. A bone
`graft made from autologous bone is an autograft, and a graft made from
`allogenic bone is called an allograft. See Ex. 1016 ¶ 25; Ex. 2001 ¶ 26.
`The composite bone graft of the ’158 patent includes a plurality of
`bone portions layered to form a graft unit and one or more biocompatible
`connectors that hold the graft unit together. Ex. 1002, code (57) (Abstract),
`1:10–16, 2:26–28. In the “Background of the Invention,” the ’158 patent
`explains that the limited size of cortical bone grafts sometimes prevented
`their use for spinal fusions:
`
`3
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`Strong cortical bone (the outer layer) is required as a strut in the
`interbody position to prevent collapse of the disc space while
`healing occurs. For example, cortical bone obtained from a
`cadaver source fashioned into struts, is not wide enough for
`optimum load bearing. This natural limitation often excludes the
`use of a bone graft product.
`Id. at 1:48–54. The ’158 patent also states that “[b]one grafts for spinal
`application often fail because they are extruded from the implantation site
`due to shifting, rotation, and slippage of the graft, are not cellularized, or fail
`mechanically.” Id. at 1:62–65.
`The ’158 patent purports to solve these problems with a composite
`bone graft that can be sized for any application, promotes the growth of
`patient bone at the implantation site, provides added stability and mechanical
`strength, and does not shift, extrude, or rotate after implantation. Id. at
`1:26–33, 2:1–7. Figure 6 of the ’158 patent is reproduced below:
`
`
`
`Figure 6 is a perspective view of a composite
`bone graft. Id. at 8:63–65.
`As depicted in Figure 6, the composite bone graft is made up of a first
`cortical bone portion 2, a second cortical bone portion 4, and a cancellous
`bone portion 3 disposed between them. Id. at 19:61–63. Cortical bone
`pins 7 hold the bone portions together. Id. at 19:63–64. The graft also
`includes textured surfaces 14a and 14b. Id.
`
`4
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`E. Illustrative Claim
`Petitioner challenges claims 1–15, which are all of the claims in the
`’158 patent. Claims 1, 2, and 13–15 are independent claims. Claim 1 is
`illustrative of the challenged claims and is reproduced below, with additional
`line breaks to facilitate review:
`1. A composite bone graft, comprising:
`a first cortical bone portion;
`a second cortical bone portion;
`a cancellous bone portion disposed between said first cortical
`bone portion and said second cortical bone portion to form a
`graft unit; and
`one or more bone pins for holding together said graft unit,
`wherein said first cortical bone portion and said second cortical
`bone portion are not in physical contact, and
`wherein said composite bone graft does not comprise an
`adhesive and
`said bone graft is not demineralized.
`Ex. 1002, 45:1–12 (additional line breaks added).
`F. Prior Art References and Testimonial Evidence
`Petitioner relies on the following references for its challenges:
`
`Name
`
`Wolter
`
`Description
`Wolter et al., “Bone Transplantation in the
`Area of the Vertebral Column,” Accident
`Medicine: Scientific and Clinical Aspects
`of Bone Transplantation, vol. 185,
`pp. 166–75 (1987).
`
`Date Exhibit
`
`1987
`
`10103
`
`
`3 Exhibit 1009 is the original, foreign language version of Wolter. Citations
`to Wolter in this decision refer to the English translation in Exhibit 1010.
`
`5
`
`

`

`Date Exhibit
`Sept. 26,
`2002
`July 10,
`2001
`Nov. 23,
`1999
`Mar. 14,
`1995
`Sept. 26,
`2000
`
`10034
`
`10065
`
`10086
`
`1012
`
`IPR2019-00569
`Patent 6,458,158 B1
`
`Description
`Name
`Grooms U.S. Patent App. Pub. No.
`2002/0138143 A1
`
`Paul
`
`U.S. Patent No. 6,258,125 B1
`
`Coates U.S. Patent No. 5,989,289
`
`Kozak U.S. Patent No. 5,397,364
`
`Boyce U.S. Patent No. 6,123,731
`
`10117
`
`
`4 Petitioner asserts that Grooms claims priority, as a continuation-in-part, to
`U.S. Patent Application No. 08/920,630 (“the ’630 application”), filed
`August 30, 1997. Pet. 20. Petitioner further asserts that Grooms qualifies as
`prior art under 35 U.S.C. § 102(e) for its disclosure supported by the written
`description of the ’630 application. Id. Patent Owner does not contest that
`Grooms qualifies as prior art as to the disclosures cited by the Petitioner
`cited in the Petition. PO Resp. 28, 28 n.5.
`5 Petitioner contends that Paul claims priority to U.S. Provisional Patent
`Application No. 60/095,209 (“the ’209 application”), filed August 3, 1998.
`Pet. 23. Petitioner asserts that Paul is prior art under 35 U.S.C. § 102(e) as
`to the disclosure supported by the written description of the ’209 application.
`Patent Owner does not contest that Paul qualifies as prior art. See generally
`PO Resp. 29–30.
`6 Petitioner asserts that Coates is prior art under 35 U.S.C. § 102(e) because
`the patent issued from an application filed October 9, 1997. Pet. 6. Patent
`Owner does not contest that Coates qualifies as prior art. See generally PO
`Resp.
`7 Petitioner argues that Boyce qualifies as prior art under 35 U.S.C. § 102(e)
`because the patent issued from an application filed February 6, 1998. Pet.
`6–7. Patent Owner does not contest that Boyce qualifies as prior art. See
`generally PO Resp.
`
`6
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`The parties have also provided witness testimony. The table below
`lists the witnesses, their roles in this proceeding, and the exhibits in which
`their testimony is presented:
`
`Witness
`Michael C.
`Sherman
`
`Role
`Petitioner’s
`technical expert8
`
`Jeffrey S.
`Fischgrund,
`M.D.
`
`Petitioner’s
`technical expert9
`
`John R.
`Bianchi
`
`Petitioner’s fact
`witness10
`
`Exhibits
`Ex. 1015 (declaration of Feb. 18, 2019)
`Ex. 2032 (transcript of deposition of Nov.
`7, 2019)
`Ex. 1026 (declaration of Feb. 25, 2020)
`Ex. 2092 (transcript of deposition of Mar.
`19, 2020)
`
`Ex. 1016 (declaration of Feb. 18, 2019)
`Ex. 2031 (transcript of deposition of Oct.
`31, 2019)
`Ex. 1028 (declaration of Feb. 23, 2020)
`Ex. 2091 (transcript of deposition of Mar.
`16, 2020)
`
`Ex. 1025 (declaration of Jan. 24, 2020)
`Ex. 2093 (transcript of deposition of Mar.
`26, 2020)
`
`
`8 See Ex. 1015 ¶ 1 (“I have been retained as an expert witness to offer
`technical opinions on behalf of RTI Surgical, Inc. . . .”).
`9 See Ex. 1016 ¶ 1 (“I have been retained as an expert witness to offer
`technical opinions on behalf of RTI Surgical, Inc. . . .”).
`10 See, e.g., Ex. 1025 ¶ 1 (“I continued working for RTI until 2006.”); id. ¶ 4
`(“I can confirm that the [Confidential Memorandum of Understanding in Ex.
`1024] is a record kept by RTI personnel in the ordinary course of
`business.”).
`
`7
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`
`Witness
`Mark E.
`Shaffrey,
`M.D.
`
`Role
`Patent Owner’s
`technical
`expert11
`
`David L.
`Kaplan,
`Ph.D.
`
`Patent Owner’s
`technical
`expert12
`
`Barton D.
`Gaskins
`
`Patent Owner’s
`fact witness13
`
`Exhibits
`Ex. 2001 (declaration of June 6, 2019)
`Ex. 2028 (declaration of Nov. 26, 2019)
`Ex. 1037 (transcript of deposition of Feb.
`5, 2020)
`
`Ex. 2002 (declaration of June 6, 2019)
`Ex. 2029 (declaration of Nov. 25, 2019)
`Ex. 1038 (transcript of deposition of Jan.
`31, 2020)
`
`Ex. 2030 (declaration of Nov. 26, 2019)
`Ex. 103914 (transcript of deposition of
`Jan. 29, 2020)
`
`Reference(s)/Basis
`Wolter in view of Grooms
`Wolter in view of Paul
`Wolter in view of Paul and Coates
`
`G. Asserted Grounds
`Petitioner asserts that claims 1–15 are unpatentable on the following
`grounds:
`Claim(s) Challenged 35 U.S.C. §
`1–12
`103(a)15
`1, 2, 11, 12
`103(a)
`3–10
`103(a)
`
`11 See, e.g., Ex. 2001 ¶ 1 (“I have been retained by Patent Owner LifeNet
`Health (“LifeNet”) as an expert. . . .”).
`12 See Ex. 2002 ¶ 1 (“I have been retained as an expert witness on behalf of
`LifeNet Health. . . .”).
`13 See Ex. 2030 ¶ 1 (“I am currently a Senior R&D Manager for LifeNet
`Health. . . .”); see also Tr. 61:8–21 (Patent Owner confirming that Mr.
`Gaskins is a fact witness); Ex. 1022, 14:19–23 (same).
`14 A public, redacted version of the Mr. Gaskins’ deposition was filed as
`Ex. 1044.
`15 The relevant sections of the Leahy-Smith America Invents Act (“AIA”),
`Pub. L. No. 112–29, took effect on March 16, 2013. Because the application
`that issued as the ’158 patent was filed before March 16, 2013, we apply the
`pre-AIA version of § 103.
`
`8
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`Claim(s) Challenged 35 U.S.C. §
`
`13
`
`14
`
`15
`
`1, 2, 11, 12, 14
`
`103(a)
`
`103(a)
`
`103(a)
`
`103(a)
`
`Reference(s)/Basis
`Wolter in view of either (1) Grooms
`or (2) the combination of Paul and
`Kozak
`Wolter in view of either (1) Grooms
`in combination with Boyce or
`(2) Paul in combination with Boyce
`Wolter in view of either (1) Grooms
`or (2) Paul
`Boyce in view of either (1) Grooms
`or (2) Paul
`
`See Pet. 5–7.
`II. LEGAL STANDARDS FOR OBVIOUSNESS
`In Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966), the
`Supreme Court set out a framework for assessing obviousness under § 103
`that requires consideration of four factors: (1) the “level of ordinary skill in
`the pertinent art,” (2) the “scope and content of the prior art,” (3) the
`“differences between the prior art and the claims at issue,” and
`(4) “secondary considerations” of non-obviousness such as “commercial
`success, long-felt but unsolved needs, failure of others, etc.” Id. at 17–18.
`“While the sequence of these questions might be reordered in any particular
`case,” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407 (2007), the Federal
`Circuit has explained that an obviousness determination can be made only
`after consideration of all of the Graham factors. Kinetic Concepts, Inc. v.
`Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir. 2012).
`III. LEVEL OF ORDINARY SKILL IN THE ART
`In our Decision on Institution, we adopted Petitioner’s proposal that
`an ordinarily skilled artisan at the time of the invention of the ’158 patent
`would have had the following education and experience:
`
`9
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`at least a bachelor’s degree in mechanical, biomechanical, or
`biomedical engineering or a closely-related discipline, as well as
`5–10 years of experience designing and developing orthopedic
`implants and/or spinal interbody devices and/or bone graft
`substitutes. Alternatively, such a person would typically have
`had an advanced degree (master’s or doctorate) in one of the
`above-identified fields, as well as 3 to 5 years of experience; or
`would be a practicing orthopedic surgeon with at least five years
`of experience.
`Dec. on Inst. 9–10 (quoting Pet. 16–17).
`Patent Owner proposes that an ordinarily skilled artisan
`would have at least a B.S. in biology, chemistry, biochemistry,
`biomedical engineering, or related fields, and two years of
`research or work experience related to bone regeneration, bone
`grafts, or tissue processing. Such experience may include
`harvesting, processing, developing, and clinically using bone
`grafts.
`PO Resp. 16 (citing Ex. 2028 ¶¶ 19–24). Patent Owner argues that
`Petitioner’s proposed level of skill in the art is not sufficiently related to the
`relevant field, as the use of “and/or” in Petitioner’s proposal does not require
`any experience with bone grafts. Id. at 17. At the oral hearing, however,
`Petitioner confirmed that it agrees that an ordinarily skilled artisan must
`have experience with bone grafts. Tr. 12:25–14:2. Consistent with the
`parties’ agreement on this point, we determine that the level of ordinary skill
`in the art requires experience with bone grafts, given the focus on composite
`bone grafts in the ’158 patent’s claims and disclosure.
`Petitioner’s proposal requires more education or experience than
`Patent Owner’s proposal. Based on the full record developed during trial,
`we find that Petitioner’s level of education and experience is more consistent
`with the level of skill reflected in the prior art references of record and the
`disclosure of the ’158 patent. See Daiichi Sankyo Co. v. Apotex, Inc., 501
`
`10
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`F.3d 1254, 1256 (Fed. Cir. 2007) (listing the type of problems encountered
`in the art, prior art solutions to those problems, and the sophistication of the
`technology as factors that may be considered in determining the level of
`ordinary skill in the art). In particular, we are unpersuaded that persons with
`an undergraduate degree and two years of experience with tissue processing
`would have the capabilities that the ’158 patent ascribes to a person of
`ordinary skill in the art, including the ability to select and employ methods
`for demineralizing bone (Ex. 1002, 13:25–28, 18:41–43), the ability to select
`appropriate dimensions for depressions or protrusions to provide an
`interlocking fit of bone portions (id. at 14:12–17), the ability to employ
`suitable methods for processing bone tissue for use in the graft (id. at 16:40–
`43), the ability to select appropriate dimensions for the graft based on the
`particular application and site of implantation in a patient (id. at 17:27–31),
`and the ability to produce pins from cortical bone and to select the
`appropriate number, orientation, and dimensions of pins (id. at 18:1–3,
`27:42–56).
`
`Accordingly, we generally adopt Petitioner’s proposed level of
`ordinary skill in the art but modified to reflect that experience with bone
`grafts is required. Thus, we determine that the person of ordinary skill in the
`art would have had at least a bachelor’s degree in mechanical,
`biomechanical, or biomedical engineering or a closely-related discipline, as
`well as 5–10 years of experience designing and developing orthopedic
`implants and/or spinal interbody devices and/or bone graft substitutes, at
`least some of which experience includes working with bone grafts.
`Alternatively, such a person would typically have had an advanced degree
`(master’s or doctorate) in one of the above-identified fields, as well as 3 to 5
`years of experience, at least some of which includes working with bone
`
`11
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`grafts. As still another alternative, the person of ordinary skill would be a
`practicing orthopedic surgeon with at least five years of experience, at least
`some of which experience includes working with bone grafts.
`We also note that the differences between the parties’ proposed
`definition of the level of ordinary skill in the art are not determinative. In
`that regard, we agree with Patent Owner that the analysis would be
`materially the same under either party’s proposed definition. See PO Resp.
`18 (“Nevertheless, the analysis of the issues in this proceeding is the same
`regardless of the level of skill ultimately adopted by the Board”).
`IV. MOTIONS TO EXCLUDE
`A. Petitioner’s Motion to Exclude
`Petitioner moves to exclude Exhibits 2085 and 2086, which are two
`claim charts Patent Owner relies on to support its assertions of nexus and
`copying. See Paper 60. As explained below, we determine that Petitioner’s
`obviousness challenges are unpersuasive even without evidence of
`secondary considerations. Therefore, we dismiss Petitioner’s motion as
`moot.
`B. Patent Owner’s Motion to Exclude
`Patent Owner moves to exclude Exhibits 1015, 1016, 1026, and 1028.
`For the reasons below, we deny Patent Owner’s motion.
`1. Exhibits 1015 and 1026
`Patent Owner moves to exclude Exhibits 1015 and 1026, which are
`declarations of Michael C. Sherman. See Paper 61. Patent Owner urges the
`exclusion of Mr. Sherman’s testimony pursuant to Federal Rule of Evidence
`702. Id. at 1; Paper 68, 1. Specifically, Patent Owner argues that Mr.
`Sherman has insufficient experience regarding composite bone grafts for
`spinal fusion and that certain opinions he expresses are based on insufficient
`
`12
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`facts. Paper 61, 4–12; Paper 68, 2–5. Relatedly, Patent Owner argues that
`Mr. Sherman’s testimony regarding issues to be considered from the
`perspective of an ordinarily skilled artisan is speculative and therefore
`inadmissible under Federal Rule of Evidence 402. Paper 61, 4–5, 12.
`Petitioner opposes the motion, arguing that Mr. Sherman has
`extensive experience under any definition of the field of invention and
`provides testimony with a sufficient factual basis. Paper 65, 7–14.
`We are not persuaded that Mr. Sherman’s testimony should be
`excluded. Mr. Sherman holds both a B.S. and M.S. in Biomedical
`Engineering. Ex. 1015, 181. He has “over thirty years of experience in the
`medical device industry,” including “over twenty years working in
`orthopedic product development with a particular emphasis on spine
`implants and instrumentation.” Id. ¶ 5; see also id. ¶¶ 3–8 (describing
`education and experience related to spinal implants and bone grafts); Ex.
`1026 ¶¶ 14–27 (same). His experience includes developing allogenic bone
`spinal implants and cortical bone screws. Ex. 1026 ¶¶ 19–25. Mr. Sherman
`testifies that his experience most directly relevant to the design of spinal
`bone grafts occurred between 1991 and 2006. Ex. 1026 ¶ 14. Thus,
`Mr. Sherman qualifies as a person of ordinary skill in the art under the
`definition we have adopted. See supra § III.
`Moreover, complete overlap between a witness’s technical
`qualifications and the field of the invention is not necessary for the witness’s
`testimony to be admissible under Federal Rule of Evidence 702. For
`example, the Federal Circuit has upheld a district court’s admission under
`Rule 702 of the testimony of a witness who lacked experience in the design
`of the patented invention, but had experience with materials selected for use
`in the invention. See SEB S.A. v. Montgomery Ward & Co., Inc., 594 F.3d
`
`13
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`1360, 1372–73 (Fed. Cir. 2010); see also Patent Trial and Appeal Board
`Consolidated Trial Practice Guide November 201916 at 34 (“There is . . . no
`requirement of a perfect match between the expert’s experience and the
`relevant field.”). Mr. Sherman has extensive experience and expertise
`related to spinal implants, including experience related to spinal bone grafts.
`Ex. 1015 ¶¶ 3, 5–7; Ex. 1026 ¶¶ 14–27. Mr. Sherman’s lack of experience
`specific to composite spinal bone grafts may detract from the weight to be
`given his testimony on certain matters, but it does not render his testimony
`inadmissible under Rule 702 or 402.
`To support its motion, Patent Owner relies heavily on Sundance, Inc.
`v. DeMonte Fabricating Ltd., 550 F.3d 1356 (Fed. Cir. 2008). See Paper 61,
`4–11. There, the Federal Circuit reviewed the district court’s denial of a
`motion to exclude a patent lawyer having no relevant technical expertise
`from testifying in a jury trial. Sundance, 550 F.3d at 1361–62. The Federal
`Circuit held that because the patent attorney “was never offered as a
`technical expert, and in fact was not qualified as a technical expert, it was an
`abuse of discretion for the district court to permit him to testify as an expert
`on the issues of noninfringement or invalidity.” Id. at 1362. The Federal
`Circuit further explained:
`The court, in its role as gatekeeper, must exclude expert
`testimony that is not reliable and specialized, and which invades
`the province of the jury to find facts and that of the court to make
`ultimate legal conclusions. Allowing a patent law expert without
`any technical expertise to testify on the issues of infringement
`and validity amounts to nothing more than advocacy from the
`witness stand.
`
`
`16 Available at www.uspto.gov/sites/default/files/documents/tpgnov.pdf.
`
`14
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`Id. at 1364–65. Here, Mr. Sherman is offered as a technical expert, and he
`has substantial technical expertise related to the field of the ’158 patent.
`Moreover, in this proceeding, fact-finding and legal determinations are
`carried out by the same panel of administrative patent judges, which
`eliminates the concern of invading the jury’s province. These distinctions
`make Sundance inapposite as a basis for excluding Mr. Sherman’s
`testimony.
`For the foregoing reasons, we deny Patent Owner’s motion to exclude
`Exhibits 1015 and 1026.
`2. Exhibits 1016 and 1028
`Patent Owner moves to exclude Exhibits 1016 and 1028, which are
`declarations of Jeffrey S. Fischgrund, M.D. See Paper 61. Patent Owner
`asserts that Dr. Fischgrund’s testimony regarding the state of the art prior to
`January 1999 should be excluded pursuant to Federal Rules of Evidence 702
`and 402 because they are not based on sufficient facts. Id. at 5, 13–14;
`Paper 68, 5. In opposition, Petitioner counters that Dr. Fischgrund’s
`testimony is based on his personal knowledge and experience. Paper 65,
`13–14 (citing Ex. 1016 ¶ 11, 32–46; Ex. 1028 ¶ 3–4, 8–11; Ex. 2091, 110:9–
`13).
`
`We are not persuaded that Dr. Fischgrund’s testimony should be
`excluded. Dr. Fischgrund testifies that he has performed spinal fusion
`surgery since 1993, and has performed over 5,000 spinal and cervical
`fusions in his career. Ex. 1016 ¶ 11. Dr. Fischgrund states that his
`knowledge regarding the state of the art is based on the “compendium of my
`knowledge of the state-of-the-art, my practice, my partners’ practice, my
`knowledge in the field, and expertise in the field.” Ex. 2091, 110:9–13.
`Moreover, Dr. Fischgrund cites to contemporaneous publications to support
`
`15
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`his testimony regarding the state of the art throughout the 1980s and 1990s.
`Ex. 1028 ¶¶ 9–10. Patent Owner’s arguments go to the weight to be given
`Dr. Fischgrund’s testimony, not its admissibility. Accordingly, we deny
`Patent Owner’s motion to exclude Exhibits 1016 and 1028.
`V. CLAIM CONSTRUCTION
`“In an inter partes review proceeding, a claim of a patent . . . shall be
`construed using the same claim construction standard that would be used to
`construe the claim in a civil action under 35 U.S.C. 282(b).” See Changes to
`the Claim Construction Standard for Interpreting Claims in Trial
`Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340,
`51,358 (Oct. 11, 2018) (amending 37 C.F.R. § 42.100(b) effective
`November 13, 2018) (now codified at 37 C.F.R. § 42.100(b) (2019)).17 That
`standard “includ[es] construing the claim in accordance with the ordinary
`and customary meaning of such claim as understood by one of ordinary skill
`in the art and the prosecution history pertaining to the patent.” Id.; see also
`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc).
`The only term that requires express construction is “composite bone
`graft.” That phrase appears in each of the challenged claims. In the
`Decision on Institution, we preliminarily construed “composite bone graft”
`to mean “a bone graft which is made up of two or more distinct bone
`portions,” which is the definition in the ’158 patent and the construction
`proposed by Petitioner. Dec. on Inst. 11–12 (citing Ex. 1002, 12:49–51; Pet.
`17). Following institution, Patent Owner agreed with that construction. PO
`Resp. 19. Therefore, we maintain the construction of “composite bone
`
`
`17 The Petition in this case was filed February 19, 2019. See Paper 3, 1.
`
`16
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`graft” in our Decision on Institution, which construction is agreed on by both
`parties and supported by the intrinsic record.
`The parties also propose different meanings for the term
`“[cortical/cancellous] bone portion.” See PO Resp. 19 (proposing “distinct
`piece(s) of bone made solely of [cortical or cancellous] bone”); Pet. Reply 2
`(proposing “part or piece of [cortical/cancellous] bone”). We determine that
`we need not construe “[cortical/cancellous] bone portion” because even
`assuming that this limitation is taught by the references Petitioner relies
`upon, we still are not persuaded that Petitioner has demonstrated
`obviousness for the reasons discussed below. Thus, construing
`“[cortical/cancellous] bone portion” is not necessary to resolve the parties’
`dispute. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999) (claim terms need only be construed “to the extent
`necessary to resolve the controversy”); see also Nidec Motor Corp. v.
`Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
`(applying Vivid Techs. in the context of an inter partes review).
`VI. OBVIOUSNESS GROUNDS LED BY WOLTER
`Wolter is the primary reference in each of Petitioner’s first six
`grounds. Each of Petitioner’s obviousness challenges led by Wolter relies
`on a base combination of Wolter with a reference that teaches a bone pin,
`either Grooms or Paul. As discussed in greater detail below, Petitioner’s
`proposed combination involves converting Wolter from an autograft to an
`allograft and substituting a bone pin (from Grooms or Paul) for Wolter’s
`metal screw. Petitioner’s arguments regarding the motivation to modify
`Wolter in those ways are common to all of the Wolter-led grounds. See Pet.
`27–28, 42–43, 46–47, 53, 57, 62–63; Tr. 35:13–17. Likewise, Patent Owner
`presents the same arguments concerning motivation for the Wolter and
`
`17
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`Grooms combination as for the Wolter and Paul combination. See PO Resp.
`35–48. Our discussion below focuses on these disputed issues regarding the
`motivation to combine Wolter with Grooms or Paul, which issues are
`dispositive of all of the Wolter-led grounds.
`A. Summary of Wolter
`Wolter describes methods of bone transplantation in the vertebral
`column. Ex. 1010, 4. The portion of Wolter’s disclosure of greatest
`relevance to Petitioner’s challenges is its description of using a “composite
`corticospongial block,” also referred to as a “sandwich block.” Figure 1e of
`Wolter is reproduced below:
`
`
`
`Figure 1e depicts the sandwich block. Id. at 10.
`Wolter describes the sandwich block as follows:
`large
`that several
`This
`transplant
`is characterized
`in
`corticospongial bone pieces are united by 1 or 2 small-fragment
`spongiosa screws into a fixed block. The removal is carried out
`from the iliac wing. The large bone piece is sawed into 2 or 3
`parts, which can be placed against one another in a precisely-
`fitting manner. This composite corticospongial block has a high
`load resistance and is able to bridge over even large defects.
`
`18
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`Id. at 5 (citations omitted).
`In preparing the sandwich block transplant, Wolter discloses that
`“[o]nly autologous material should be used upon bone transplantation in the
`vertebral column area for the filling out of defects and for accumulations, as
`well as for intersegmental stiffening.” Id. at 9.
`B. Summary of Grooms
`Grooms relates to a bone implant for use in spinal fusion procedures.
`Ex. 1003 ¶ 3. Specifically, Grooms describes “a cortical bone intervertebral
`implant having a substantially ‘D’- or bread-loaf-shaped structure having a
`canal into which osteogenic, osteoinductive, or osteoconductive materials
`may be packed, which sustains spinal loads, and which is remodeled into the
`spine in the course of fusion.” Id. ¶ 9. Figure 8A of Grooms is reproduced
`below:
`
`
`Figure 8A shows implant 800 made of two side-
`by-side halves 801A and 801B of cortical bone.
`Id. ¶ 49.
`Grooms discloses that the implant halves can be held together by drilling
`holes through the implants and forcing pins, made of cortical bone, through
`the holes. Id. ¶¶ 48–49. Grooms discloses that the implant may be made of
`autograft or allograft bone. Id. ¶ 24.
`
`19
`
`

`

`IPR2019-00569
`Patent 6,458,158 B1
`C. Summary of Paul
`Paul discloses an allogenic intervertebral implant for spinal fusion.
`Ex. 1006, 1:9–11, 2:12–14. Figure 7 of Paul is reproduced below:
`
`
`Figure 7 shows a side view of implant 50. Id. at 3:1.
`Implant 50 includes top and bottom portions 52, 54, which are retained
`together with pins 64 passing through aligned holes 66. Id. at 4:58–60.
`“Although pin 64 can be made of any biocompatible material, pin 64 is
`preferably made of allogenic bone.” Id. at 4:60–62.
`D. Analysis of Petitioner’s Proposed Combinations Based on Wolter
`1. Claim 1
`Petitioner’s Proposed Combination
`a)
`Petitioner contends in Ground 1 that Wolter teaches each limitation of
`claim 1, except for the limitation of one or more bone pins to hold together
`portions of the graft. See Pet. 27–31, 42–45. Petitioner asserts that Grooms
`teaches the bone pin limitation, and that an ordinarily skilled artisan would
`have been motivated to incorporate that feature from Grooms into Wolter.
`Id. at 29–30. Petitioner also contends in Ground 2 that Paul teaches the bone
`pin limitation, and that an ordinarily sk

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