UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`SURGALIGN SPINE TECHNOLOGIES, INC. (f/k/a RTI SURGICAL, INC.),
`Petitioner
`
`v.
`
`LIFENET HEALTH,
`Patent Owner
`______________
`
`Case IPR2019-00570
`Patent No. 8,182,532
`_____________
`
`SURGALIGN SPINE TECHNOLOGIES, INC.’S NOTICE OF APPEAL
`TO THE U.S. COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`
`
`Via PTAB E2E
`Patent Trial and Appeal Board
`
`Via Hand Delivery
`Director of the U.S. Patent & Trademark Office
`c/o Office of the General Counsel, 10B20
`Madison Building East
`600 Dulany Street
`Alexandria, VA 22314
`
`Via CM/ECF
`United States Court of Appeals for the Federal Circuit
`
`
`
`_____________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`SURGALIGN SPINE TECHNOLOGIES, INC. (f/k/a RTI SURGICAL, INC.),
`Petitioner
`
`v.
`
`LIFENET HEALTH,
`Patent Owner
`______________
`
`Case IPR2019-00570
`Patent No. 8,182,532
`_____________
`
`SURGALIGN SPINE TECHNOLOGIES, INC.’S NOTICE OF APPEAL
`TO THE U.S. COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`
`
`Via PTAB E2E
`Patent Trial and Appeal Board
`
`Via Hand Delivery
`Director of the U.S. Patent & Trademark Office
`c/o Office of the General Counsel, 10B20
`Madison Building East
`600 Dulany Street
`Alexandria, VA 22314
`
`Via CM/ECF
`United States Court of Appeals for the Federal Circuit
`
`
`
`
`Case IPR2019-00570
`U.S. Patent 8,182,532
`
`Pursuant to 35 U.S.C. §§ 141, 142, and 319, 37 C.F.R. §§ 90.2, 90.3, and
`
`104.2, and Rule 15 of the Federal Circuit Rules, Petitioner Surgalign Spine
`
`Technologies, Inc. hereby appeals to the United States Court of Appeals for the
`
`Federal Circuit from the Final Written Decision (Paper 71) entered by the Patent
`
`Trial and Appeal Board on August 26, 2020. Please note that the Final Written
`
`Decision in this matter has been sealed to the public, and currently only the Parties
`
`and the Board have access to it. The redacted version (Paper 74) of the Decision is
`
`attached to this Notice.
`
`In accordance with 37 C.F.R. § 90.2(a)(3)(ii), Petitioner identifies at least the
`
`following issues for appeal:
`
`
`
`The Board’s judgment that Claims 4 and 6-11 of Patent No. 8,182,532
`
`are not unpatentable and any finding or determination supporting or
`
`related to that judgment;
`
`
`
`
`
`The Board’s claim constructions, including but not limited to its
`
`construction of “plate-like”; and
`
`Any Board finding, determination, judgment, or order supporting or
`
`related to the Final Written Decision and decided adversely to
`
`Petitioner.
`
`- 2 -
`
`
`
`Case IPR2019-00570
`U.S. Patent 8,182,532
`
`Petitioner is concurrently filing true and correct copies of this Notice of
`
`Appeal, along with the required fees, with the United States Court of Appeals for the
`
`Federal Circuit, and with the USPTO Patent Trial and Appeal Board.
`
`
`
`
`
`
`
`
`
`
`
`
`
`Dated: October 27, 2020
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`/David D. Headrick/
`David D. Headrick
`Registration No. 40,642
`MCANDREWS HELD & MALLOY
`500 West Madison, 34th Floor
`Chicago, IL 60661
`Telephone: (312) 775-8000
`Facsimile: (312) 775-8100
`
`- 3 -
`
`
`
`Case IPR2019-00570
`U.S. Patent 8,182,532
`
`
`CERTIFICATE OF FILING
`
`The undersigned hereby certifies that, in addition to being electronically filed
`
`through PTAB E2E, a true and correct copy of the above-captioned SURGALIGN
`
`SPINE TECHNOLOGIES, INC.’S NOTICE OF APPEAL is being served by
`
`hand delivery to the Director of the United States Patent and Trademark Office, on
`
`October 27, 2020, at the following address:
`
`Director of the U.S. Patent & Trademark Office
`c/o Office of the General Counsel, 10B20
`Madison Building East
`600 Dulany Street
`Alexandria, VA 22314
`
`The undersigned also herby certifies that a true and correct copy of the above-
`
`
`
`captioned SURGALIGN SPINE TECHNOLOGIES, INC.’S NOTICE OF
`
`APPEAL and the filing fee is being filed via CM/ECF with the Clerk’s Office of
`
`the United States Court of Appeals for the Federal Circuit on October 27, 2020.
`
`
`Dated: October 27, 2020
`
`
`
`
`
`
`
`
`
`/David D. Headrick/
`David D. Headrick
`(Registration No. 40,642)
`Counsel for Petitioner
`Surgalign Spine Technologies, Inc.
`
`
`
`
`
`Case IPR2019-00570
`U.S. Patent 8,182,532
`
`
`CERTIFICATE OF SERVICE
`The undersigned hereby certify that the foregoing SURGALIGN SPINE
`
`
`
`
`
`TECHNOLOGIES INC.’S NOTICE OF APPEAL was filed through the PTAB’s
`
`E2E Processing System as well as served electronically via e-mail on October 27,
`
`2020 in its entirety on the following:
`
`
`
`
`
`Dated: October 27, 2020
`
`
`
`
`
`Michael H. Jacobs
`mjacobs@crowell.com
`
`Deborah H. Yellin
`dyellin@crowell.com
`
`Vincent J. Galluzzo
`vgalluzzo@crowell.com
`
`LifeNet-RTI@crowell.com
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/David D. Headrick/
`David D. Headrick
`Registration No. 40,642
`
`
`
`
`
`
`MCANDREWS HELD & MALLOY
`500 West Madison, 34th Floor
`Chicago, IL 60661
`Telephone: (312) 775-8000
`Facsimile: (312) 775-8100
`
`
`
`
`Trials@uspto.gov
`571-272-7822
`
`Paper 71
`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.
`
`IPR2019-00570
`Patent 8,182,532 B2
`
`
`
`
`
`
`
`
`
`Before GEORGE R. HOSKINS, TIMOTHY J. GOODSON, and
`CHRISTOPHER C. KENNEDY, Administrative Patent Judges.
`GOODSON, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining Some Challenged Claims Unpatentable
`Granting 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 70.
`
`
`
`
`
`IPR2019-00570
`Patent 8,182,532 B2
`
`
`
`2
`
`INTRODUCTION
`I.
`A. Background and Summary
`Petitioner filed a Petition (Paper 2, “Pet.”) requesting inter partes
`review of claims 4 and 6–21 of U.S. Patent No. 8,182,532 B2 (Ex. 1001,
`“the ’532 patent”). Patent Owner filed a Preliminary Response. Paper 11
`(“Prelim. Resp.”). We instituted an inter partes review on all claims and all
`grounds asserted in the Petition. See Paper 16 (“Dec. on Inst.”).
`After institution of trial, Patent Owner filed a Patent Owner Response.
`Paper 28 (“PO Resp.”).2 Petitioner filed a Reply. Paper 39 (“Pet. Reply”).
`Patent Owner filed a Sur-Reply. Paper 54 (“Sur-Reply”). We held a hearing
`on June 2, 2020, a transcript of which is included in the record. See Paper
`68 (“Tr.”).
`The parties have also filed motions to exclude, which we address
`below in Section III. For the reasons discussed therein, we grant Petitioner’s
`motion to exclude and deny Patent Owner’s motion to exclude.
`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
`shown by a preponderance of the evidence that claims 12–21 of the ’532
`
`2 A public, redacted version of the Patent Owner Response was filed as
`Paper 29.
`
`
`
`
`
`
`
`IPR2019-00570
`Patent 8,182,532 B2
`
`
`patent are unpatentable, but Petitioner has not shown by a preponderance of
`the evidence that claims 4 and 6–11 are unpatentable.
`B. Real Parties in Interest
`The parties list only themselves as real parties in interest. See Pet. 2;
`Paper 5, 1.
`C. Related Matters
`Patent Owner is asserting the ’532 patent against Petitioner in LifeNet
`Health v. RTI Surgical, Inc., No. 1:18-cv-00146-MW-GRJ (N.D. Fla.). See
`Pet. 2; Paper 5, 1. The parties also list another proceeding at the Board as a
`related matter: Case IPR2019-00569, which challenges U.S. Patent No.
`6,458,158 (“the ‘158 patent”). See Pet. 2; Paper 5, 1.
`D. The ’532 Patent
`The ’532 patent relates to a composite bone graft for spinal fusion.
`Ex. 1001, 1:15–16. 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 ’532 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. 1001, code (57) (Abstract),
`
`
`3
`
`
`
`
`
`IPR2019-00570
`Patent 8,182,532 B2
`
`
`1:18–24, 2:30–33. In the “Background of the Invention,” the ’532 patent
`explains that the limited size of cortical bone grafts sometimes prevented
`their use for spinal fusions:
`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 1:52–58. The ’532 patent also states that “[b]one grafts for spinal
`applications 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 1:66–2:2.
`The ’532 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
`1:33–37, 2:5–11. Figure 6 of the ’532 patent is reproduced below:
`
`
`Figure 6 is a perspective view of a composite
`bone graft. Id. at 8:55–56.
`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
`
`
`4
`
`
`
`
`
`IPR2019-00570
`Patent 8,182,532 B2
`
`
`bone portion 3 disposed between them. Id. at 19:40–42. Cortical bone pins
`7 hold the bone portions together. Id. at 19:42–43. The graft also includes
`textured surfaces 14a and 14b. Id.
`E. Illustrative Claims
`Petitioner challenges claims 4 and 6–21. Of the challenged claims,
`claims 4 and 12 are independent claims. Claims 4 and 12 are reproduced
`below with italics added to emphasize the language of greatest significance
`to the analysis herein.
`4. A composite spinal bone graft comprising:
`a graft unit having one or more through-holes configured to
`accommodate one or more pins, said graft unit comprising:
`a first plate-like cortical bone portion configured to contact a
`portion of the host bone;
`a second plate-like cortical bone portion configured to contact
`a portion of the host bone;
`a plate-like cancellous bone portion disposed between said first
`plate-like cortical bone portion and said second plate-like
`cortical bone portion and configured to contact a portion of the
`host bone to form said graft unit; and
`one or more cortical bone pins connecting bone portions of said
`bone graft unit, said composite spinal bone graft having a shape
`selected from the group consisting of a parallelepiped, a
`parallel block, a square block, a trapezoid wedge, a cylinder, a
`flattened curved block, a tapered cylinder, and a polyhedron,
`wherein said composite spinal bone graft comprises one or
`more textured surfaces comprising a plurality of closely spaced
`continuous protrusions in a linear arrangement and said spinal
`bone graft is configured for implantation into the anterior spinal
`column of the host.
`Ex. 1001, 46:48–47:3 (emphasis added).
`
`
`
`5
`
`
`
`
`
`IPR2019-00570
`
`Patent 8,182,532 B2
`
`12. A load-bearing composite spinal bone graft for implantation
`into a host, the load-bearing composite graft comprising:
`
`a first cortical bone portion comprising one or more textured
`surfaces configured to contact a portion of the host bone;
`
`a second cortical bone portion comprising one or more textured
`surfaces configured to contact a portion of the host bone;
`
`one or more osteoconductive substances disposed between said
`first cortical bone portion and said second cortical bone portion
`and configured to contact a portion of the host bone to form a
`graft unit;
`
`one or more non-adhesive mechanical connectors for holding
`together said load-bearing spinal bone graft unit, said spinal
`bone graft being configured for implantation into the anterior
`spinal column of the host.
`
`Id. at 47:51—67 (emphasis added).
`
`F. Prior Art References and Testimonial Evidence
`
`Petitioner relies on the following references for its challenges:
`
`--—m
`US. Patent App. Pub. No.
`Sept. 26,
`3
`2002/0138143 A1
`2002
`
`1003 McIntyre US. Patent No. 4,950,296
`
`A3931,
`
`1005
`
`3 Petitioner asserts that Grooms claims priority, as a continuation-in-part, to
`US. patent application 08/920,630 (“the ’630 application”), filed August 30,
`1997. Pet. 16. Petitioner further asserts that Grooms qualifies as prior art
`under 35 U.S.C. § 102(c) 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 in
`the Petition. Prelim. Resp. 13—14; PO Resp. 26 n.5.
`
`
`
`IPR2019-00570
`
`Patent 8,182,532 B2
`
`Date
`
`US. Patent No. 6,258,125 B1
`
`US. Patent No. 5,989,289
`
`July 10,
`2001
`
`Nov. 23,
`1999
`
`
`
` Description
` 166—75 (1987).
`
`Wolter et 3]., “Bone Transplantation in the
`Area of the Vertebral Column,” Accident
`Medicine: Scientific and Clinical Aspects
`ofBone Transplantation, vol. 185, pp.
`
`1987
`
`
`
`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:
`
`4 Petitioner contends that Paul claims priority to US. provisional application
`60/095,209 (“the ’209 application”), filed August 3, 1998. Pet. 19.
`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. 27—28.
`5 Petitioner asserts that Coates is prior art under 35 U.S-C- § 102(6) because
`the patent issued from an application filed October 9, 1997. Pet. 5. Patent
`Owner does not contest that Coates qualifies as prior art. See generally PO
`Resp.
`6 Exhibit 1009 is the original, foreign language version of Wolter. Citations
`to Wolter in this decision refer to the English translation in Exhibit 1010.
`
`
`
`IPR2019-00570
`
`Patent 8,182,532 B2
`
`Witness
`
`Role
`
`Exhibits
`
`Michael C.
`Sherman
`
`Petitioner’s
`-
`techmcal expert
`
`7
`
`Jeffrey S.
`-
`Flschgrund,
`MD
`
`Petitioner’s
`-
`techmcal expert
`
`s
`
`
`
`John R.
`.
`-
`Bland“
`
`Petitioner’s fact
`'
`9
`Witness
`
`Mark E.
`Shaffiey»
`M.D.
`
`Patent Owner’s
`ted‘mcal
`expert10
`
`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)
`
`Ex. 2001 (declaration of June 6, 2019)
`Ex. 2028 (declaration of Nov. 26,2019)
`_
`_
`_
`Ex. 1037 (transcript of deposrtlon of Feb.
`5, 2020)
`
`
`
`7 See Ex. 1015 1] l (“I have been retained as an expert witness to offer
`technical opinions on behalf of RTI Surgical, Inc- .
`. .”).
`8 See Ex. 1016 1] 1 (“I have been retained as an expert witness to offer
`technical opinions on behalf of RTI Surgical, Inc. .
`. .”).
`9 See, e.g., Ex. 1025 1] 1 (“I continued working for RTI until 2006.”); id. 1] 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”).
`10 See Ex. 2001 1] l (“I have been retained by Patent Owner LifeNet Health
`(“LifeNet”) as an expert. .
`. .”).
`
`
`
`IPR2019-00570
`
`Patent 8,182,532 B2
`
`Ex. 1038 (transcript of deposition of Jan.
`31, 2020)
`
`Jan. 29, 2020)
`
`
`
`
`
`
`
`Ex. 2002 (declaration of June 6, 2019)
`Patent Owner’s
`Kaplan,
`technical
`Ex. 2029 (declaration of Nov. 25, 2019)
`
`expertll
`PhD-
`
`
`
`
`Gaskins
`
`Patent Owner’s
`fact witness12
`
`Ex. 2030 (declaration of Nov. 26, 2019)
`
`Ex. 1039l3 (transcript of deposition of
`
`
`
`G. Asserted Grounds
`
`Petitioner asserts that claims 4 and 6—21 are unpatentable on the
`
`following grounds:
`
`35 U.S.C. §
`
`Reference(s)/Basis
`
`Claims Challenged
`12—21
`
`4, 6—11
`
`13—19
`
`4, 6—9, 11
`
`12, 20
`
`
`
`103(a)
`
`102(e) or
`
`103(a)
`
`102(b)
`
`Grooms
`
`Grooms in View of McIntyre
`
`Paul in View of Coates
`
`2:11;: v1ew ofMcIntyre and
`
`Wolter
`
`1‘ See Ex. 2002 1] l (“I have been retained as an expert witness on behalf of
`LifeNet Health. .
`. .”).
`‘2 See Ex. 2030 1] l (“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).
`‘3 A public, redacted version of the Mr. Gaskins’ deposition was filed as
`Ex. 1044.
`
`14 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 ’532 patent was filed before March 16, 2013, we apply the
`pre-AIA version of § 103.
`
`
`
`IPR2019-00570
`
`Patent 8,182,532 B2
`
`Claims Challenged
`
`35 U.S.C. §
`
`Reference(s)/Basis
`
`
`
`12, 20
`
`4, 6—11
`
`4, 6—9, 11
`
`103(3)
`
`gig: 1n View of Grooms, Paul, or
`
`Wolter in View of Grooms
`
`103(a)
`
`Wolter in View of Paul and Coates
`
`See Pet. 4—5.
`
`II. 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 ’532 patent
`
`would have had the following education and experience:
`
`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—5 years of experience; or
`would be a practicing orthopedic surgeon with at least five years
`of experience.
`
`Dec. on Inst. 6 (quoting Pet. 13—14).
`
`Patent Owner proposes that an ordinarily skilled artisan
`
`would have at least a BS. 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, machining, and clinically
`using bone grafts.
`
`PO Resp. 12 (citing Ex. 2028 11‘“ 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 12—13. At the oral hearing, however,
`
`Petitioner confirmed that it agrees that an ordinarily skilled artisan must
`
`10
`
`
`
`IPR2019-00570
`Patent 8,182,532 B2
`
`11
`
`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 ’532 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 ’532 patent. See Daiichi Sankyo Co. v. Apotex, Inc., 501
`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 ’532 patent ascribes to a person of
`ordinary skill in the art, including the ability to select and employ methods
`for demineralizing bone (Ex. 1001, 13:1–5, 18:18–20), the ability to select
`appropriate dimensions for depressions or protrusions to provide an
`interlocking fit of bone portions (id. at 13:55–60), the ability to employ
`suitable methods for processing bone tissue for use in the graft (id. at 16:17–
`20), the ability to select appropriate dimensions for the graft based on the
`particular application and site of implantation in a patient (id. at 17:6–9), and
`the ability to produce pins from cortical bone and to select the appropriate
`number, orientation, and dimensions of pins (id. at 17:46–49, 27:19–25).
`
`Accordingly, we generally adopt Petitioner’s proposed level of
`ordinary skill in the art but modified to reflect that experience with bone
`
`
`
`
`
`
`
`
`IPR2019-00570
`Patent 8,182,532 B2
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`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
`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.
`III. MOTIONS TO EXCLUDE
`A. Petitioner’s Motion to Exclude
`Petitioner moves to exclude Exhibits 2085 and 2086, which are two
`claim charts that Patent Owner relies on to support its assertions of nexus
`and copying. See Paper 57. Petitioner argues that Exhibits 2085 and 2086
`are irrelevant attorney argument under Federal Rules of Evidence 401 and
`402, and that Patent Owner improperly attempts to incorporate by reference
`these arguments in violation of 37 C.F.R. § 42.6(a)(3). Paper 57, 5–7; Paper
`65, 2–4. Petitioner further argues that each row of the claim charts contain
`inadmissible hearsay under Federal Rules of Evidence 801 and 802. Paper
`57, 7–9; Paper 65, 4–5.
`Patent Owner opposes the motion, arguing that the claim charts
`include only factual information reproduced from authenticated evidence of
`record properly before the Board. Paper 64, 2–6. Patent Owner further
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`13
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`argues that certain statements in Exhibit 2086 are statements by a party
`opponent. Id. at 7.
`We agree with Petitioner that Exhibits 2085 and 2086 should be
`excluded because they represent argument that Patent Owner attempts to
`incorporate by reference in violation of 37 C.F.R. § 42.6(a)(3). Under 37
`C.F.R. § 42.6(a)(3), “[a]rguments must not be incorporated by reference
`from one document into another document.” The Federal Circuit recently
`upheld the Board’s application of § 42.6(a)(3) to exclude claim charts
`through which a patent owner attempted to incorporate objective indicia
`arguments by reference. See Boston Scientific Neuromodulation Corp. v.
`Nevro Corp., __ F. App’x. __, 2020 WL 2787715, at *7–8 (Fed. Cir. May
`29, 2020). The same result should obtain here.
`The claim charts do not represent the testimony of any witness.
`Patent Owner relies exclusively on Dr. Shaffrey’s testimony to tie the
`commercial products to the claims. Tr. 98:8–99:19. But Dr. Shaffrey only
`testifies that “the grafts in the LifeNet patents track and are consistent with
`the VG2 grafts.” Ex. 2028 ¶ 51. Dr. Shaffrey’s declaration does not even
`mention Exhibits 2085 or 2086. See id. ¶¶ 46–51. Patent Owner does not
`point to any testimony of Dr. Shaffrey, or any other witness, stating that the
`claim charts at issue reflect the witness’s analysis of how the claim
`limitations line up with the commercial products. See generally Paper 64.
`Because the claim charts do not represent testimonial evidence from a
`witness, they are simply a compilation of how Patent Owner correlates claim
`limitations to the features of certain products. That is argument. The claim
`charts contain: (1) claim language from the ’158 patent and the ’532 patent
`reproduced in the left column, and (2) product information and testimony in
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`the right column. See Paper 64, 2. That the constituent parts of the claim
`charts are admissible individually does not establish that the charts
`themselves are permissible. The entire purpose of the charts is to present
`argument that various products have the claimed features. As such, the
`claim charts constitute argument, to which we give no weight to the extent
`those arguments are not set forth independently in the Patent Owner
`Response.
`For the foregoing reasons, we grant Petitioner’s motion to exclude.
`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.
`Exhibits 1015 and 1026
`1.
`Patent Owner moves to exclude Exhibits 1015 and 1026, which are
`declarations of Michael C. Sherman. See Paper 58. Patent Owner urges the
`exclusion of Mr. Sherman’s testimony pursuant to Federal Rule of Evidence
`702. Id. at 1; Paper 66, 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
`facts. Paper 58, 4–12; Paper 66, 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 58, 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 62, 7–14.
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`Patent 8,182,532 B2
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`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 testifies that 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). He also testifies that his experience included
`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 § II.
`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
`1360, 1372–73 (Fed. Cir. 2010); see also Patent Trial and Appeal Board
`Consolidated Trial Practice Guide November 201915 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
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`15 Available at www.uspto.gov/sites/default/files/documents/tpgnov.pdf.
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`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 58,
`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.
`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 ’532 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
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`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.
`Exhibits 1016 and 1028
`2.
`Patent Owner moves to exclude Exhibits 1016 and 1028, which are
`declarations of Jeffrey S. Fischgrund, M.D. See Paper 58. 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 66, 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).
`
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`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
`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.
`
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`IPR2019-00570
`Patent 8,182,532 B2
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`IV. CLAIM CONSTRUCTION
`“In an inter partes review proceeding, a claim of a patent . . . shall be
`construed using the same claim construction
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