Trials@uspto.gov
`571-272-7822
`
`
` Paper 57
` Entered: July 8, 2020
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ALPHATEC HOLDINGS, INC. and ALPHATEC SPINE, INC.,
`Petitioner,
`
`v.
`
`NUVASIVE, INC.,
`Patent Owner.
`____________
`
`IPR2019-00362
`Patent 8,361,156 B2
`____________
`
`
`Before DENISE M. POTHIER, HYUN J. JUNG, and
`SHEILA F. McSHANE, Administrative Patent Judges.
`
`POTHIER, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`Denying Patent Owner’s Motion to Exclude
`35 U.S.C. § 318(a)
`
`
`
`
`
`
`
`571-272-7822
`
`
` Paper 57
` Entered: July 8, 2020
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ALPHATEC HOLDINGS, INC. and ALPHATEC SPINE, INC.,
`Petitioner,
`
`v.
`
`NUVASIVE, INC.,
`Patent Owner.
`____________
`
`IPR2019-00362
`Patent 8,361,156 B2
`____________
`
`
`Before DENISE M. POTHIER, HYUN J. JUNG, and
`SHEILA F. McSHANE, Administrative Patent Judges.
`
`POTHIER, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`Denying Patent Owner’s Motion to Exclude
`35 U.S.C. § 318(a)
`
`
`
`
`
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`
`I. INTRODUCTION
`A. Background and Summary
`Alphatec Holdings, Inc. and Alphatec Spine, Inc. (collectively,
`“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting inter partes review
`of claims 1–3, 5, 9, 10, 12–21, 23, 24, and 27 (“the challenged claims”) of
`U.S. Patent No. 8,361,156 B2 (Ex. 1001, “the ’156 patent”). NuVasive Inc.
`(“Patent Owner”) filed a Preliminary Response (Paper 11, “Prelim. Resp.”).
`Pursuant to 35 U.S.C. § 314, we granted the request and instituted inter
`partes review on July 9, 2019, as to the challenged claims on all grounds.
`Paper 18 (“Dec. Inst.”).
`Following institution, Patent Owner filed a Response (Paper 27, “PO
`Resp.”), Petitioner filed a Reply (Paper 34, “Reply”), and Patent Owner filed
`a Sur-Reply (Paper 40,“Sur-reply”). Patent Owner objected to evidence
`submitted by Petitioner in its Petition and future filings (Papers 23, 35).
`With prior authorization (Paper 37), Patent Owner submitted a Supplemental
`Sur-Reply (Paper 41, “Supp. Sur-reply”) related to the its objections and
`Petitioner submitted a Supplemental Sur-sur-reply (Paper 42, “Supp. Sur-
`sur-reply”). Patent Owner also filed a Motion to Exclude (Paper 38, “Mot.
`Excl.”), Petitioner filed an Opposition to the Motion to Exclude (Paper 44,
`“Opp.”), and Patent Owner filed a Reply to support the Motion to Exclude
`(Paper 48, “Mot. Reply”).
`A hearing was held on April 3, 2020, and a transcript of the hearing
`has been made part of the record. Paper 54; Ex. 1066.
`We have jurisdiction under 35 U.S.C. § 6(c). This Final Written
`Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`
`
`
`2
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`For the reasons discussed below, we conclude that Petitioner has not shown
`by a preponderance of the evidence that the challenged claims of the ’156
`patent are unpatentable. We also deny Patent Owner’s Motion to Exclude.
`B. Related Matters
`The parties indicate that the ’156 patent has been asserted in
`NuVasive, Inc. v. Alphatec Holdings, Inc., Case No. 3:18-cv-00347-CAB-
`MDD (S.D. Cal.) and Warsaw Orthopedic, Inc. v. NuVasive, Inc., Case No.
`3:12-cv-02738-CAB-MDD (S.D. Cal.). Pet. 76–77; Paper 4, 2. Petitioner
`indicates the latter litigation was settled on July 27, 2016. Pet. 77.
`The parties also note that the ’156 patent was previously challenged in
`Cases IPR2013-00504, IPR2013-00506, and IPR2014-00487. Pet. 16, 21;
`Paper 4, 2 (citing In re NuVasive, Inc., 842 F.3d 1376 (Fed. Cir. 2016)). The
`panel denied institution in IPR2013-00504 and IPR2014-00487. IPR2013-
`00504, Paper 8 (PTAB February 13, 2014); IPR2014-00487, Paper 8 (PTAB
`September 11, 2014). In IPR2013-00506, the Board determined that claims
`1–14, 19, 20, and 23–27 of the ’156 patent were unpatentable. IPR2013-
`00506, Paper 47, 24 (PTAB February 11, 2015). The Federal Circuit
`vacated the decision in IPR2013-00506 and remanded for additional findings
`and explanation. In re NuVasive, 842 F.3d 1376, 1384 (Fed. Cir. 2016). On
`remand, the parties indicated that they had entered into a settlement
`agreement, and the panel granted a joint motion to terminate the proceeding.
`IPR2013-00506, Paper 57 (PTAB May 9, 2017).
`The parties also state that a related patent, U.S. Patent 8,187,334, is
`challenged in Cases IPR2019-00361 and IPR2019-00546. Pet. 77; Paper 4,
`2 (further citing Cases IPR2013-00507 and IPR2013-00508 and In re
`NuVasive, Inc., 841 F.3d 966 (Fed. Cir. 2016)); Paper 7, 2.
`
`
`
`3
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`
`C. The ’156 Patent (Ex. 1001)
`The ’156 patent issued January 29, 2013, from an application filed
`April 6, 2012, which is a continuation of an application filed on April 5,
`2012, which is a continuation of an application filed on April 4, 2011, which
`is a continuation of an application filed on March 29, 2005, and claims
`priority to a provisional application filed on March 29, 2004. Ex. 1001,
`codes (22), (45), (60), (63), 1:6–15.
`The ’156 patent relates to “a system and method for spinal fusion
`comprising a spinal fusion implant of non-bone construction . . . to introduce
`the spinal fusion implant into any of a variety of spinal target sites.” Id. at
`1:21–25. Figure 2 of the ’156 patent is reproduced below.
`
`
`Figure 2, above, shows a perspective view of a lumbar fusion implant.
`Id. at 3:36. The spinal fusion implant is introduced into a lumbar disc space
`through a lateral, a posterior, an anterior, an antero-lateral, or a postero-
`lateral approach to the spine. Id. at 5:29–35. The implant is made from a
`
`
`
`4
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`radiolucent material, such as poly-ether-ether-ketone (PEEK). Id. at
`5:10–15.
`Common attributes of the various embodiments of spinal fusion
`implant 10 include top surface 31, bottom surface 33, lateral sides 14,
`proximal side 22, and distal side 16. Id. at 6:6–9, Figs. 2–3. By way of
`example, spinal fusion implant 10 for lumbar fusion may have “a width
`ranging between 9 and 18 mm, a height ranging between 8 and 16 mm, and a
`length ranging between 25 and 45 mm.” Id. at 5:15–19; see id. at 2:17–21.
`Spinal fusion implant 10 also preferably includes anti-migration
`features, such as ridges 6 and spike elements 7–9, designed to increase
`friction between spinal fusion implant 10 and adjacent contacting surfaces of
`vertebral bodies. Id. at 6:21–32, Figs. 2–3. Spike elements 7–9 are
`preferably made from materials having radiopaque characteristics that are
`“observable under X-ray and fluoroscopy[,] such that a surgeon may track
`the progress of the implant 10 during implantation and/or the placement of
`the implant 10 after implantation.” Id. at 6:35–38.
`Spinal fusion implant 10 has fusion apertures 2, separated by medial
`support 50, extending through top surface 31 and bottom surface 33. Id. at
`6:57–59, Figs. 2–3. “[F]usion apertures 2 function primarily as an avenue
`for bony fusion between adjacent vertebrae.” Id. at 6:59–61.
`D. Illustrative Claim
`The ’156 patent has 27 claims. Ex. 1001, 12:32–14:43. Petitioner
`challenges claims 1–3, 5, 9, 10, 12–21, 23, 24, and 27. Claim 1 is the only
`independent claim and is reproduced below.
`1. A spinal fusion
`implant of non-bone construction
`positionable within an interbody space between a first vertebra
`and a second vertebra, said implant comprising:
`
`
`
`5
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`
`an upper surface including anti-migration elements to
`contact said first vertebra when said implant is positioned within
`the interbody space, a lower surface including anti-migration
`elements to contact said second vertebra when said implant is
`positioned within the interbody space, a distal wall, a proximal
`wall, a first sidewall, and a second sidewall generally opposite
`from the first sidewall, wherein said distal wall, proximal wall,
`first sidewall, and second sidewall comprise a radiolucent
`material;
`wherein said implant has a longitudinal length extending
`from a proximal end of said proximal wall to a distal end of said
`distal wall, said implant has a maximum lateral width extending
`from said first sidewall to said second sidewall along a medial
`plane that is generally perpendicular to said longitudinal length,
`and said longitudinal length is greater than said maximum lateral
`width;
`at least a first fusion aperture extending through said upper
`surface and lower surface and configured to permit bone growth
`between the first vertebra and the second vertebra when said
`implant is positioned within the interbody space, said first fusion
`aperture having: a longitudinal aperture length extending
`generally parallel to the longitudinal length of said implant, and
`a lateral aperture width extending between said first sidewall to
`said second sidewall, wherein the longitudinal aperture length is
`greater than the lateral aperture width; and
`at least first and second radiopaque markers oriented
`generally parallel to a height of the implant, wherein said first
`radiopaque marker extends into said first sidewall at a position
`proximate to said medial plane, and said second radiopaque
`marker extends into said second sidewall at a position proximate
`to said medial plane.
`
`Id. at 12:32–67 (emphasis added).
`E. Prior Art and Asserted Grounds
`Petitioner asserted the following grounds of unpatentability in the
`Petition:
`
`
`
`6
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`
`Claim(s)
`Challenged
`1–3, 5, 9, 10,
`12–21, 23, 24, 27
`9
`
`35 U.S.C. §1
`
`§ 103
`
`§ 103
`
`References/Basis
`
`Brantigan2, Baccelli3, Berry4
`
`Brantigan, Baccelli, Berry,
`Michelson ’9735
`
`
`Pet. 21–22, 28–75.
`In support of its challenges, Petitioner provides a Declaration of
`Charles L. Branch, Jr., M.D. (Ex. 1002). See Pet. 21–22, 26–28.
`To support its position, Patent Owner provides a Declaration of Jim
`A. Youssef, M.D. (Exs. 2013, 2055) and Carl R. McMillin, Ph.D. (Ex.
`2057).
`F. Real Parties in Interest
`Petitioner identifies Alphatec Holdings, Inc. and Alphatec Spine, Inc.
`as the real parties in interest. Pet. 76. Patent Owner identifies NuVasive,
`Inc. as the real party in interest. Paper 4, 2.
`
`
`
`1 The Leahy-Smith America Invents Act (“AIA”) amended 35 U.S.C. § 103.
`See Pub. L. No. 112-29, 125 Stat. 284, 285–88 (2011). As the application
`that issued as the ’156 patent was filed before the effective date of the
`relevant amendments, the pre-AIA version of § 103 applies.
`2 Brantigan, U.S. Patent No. 5,192,327, issued March 9, 1993 (Ex. 1007,
`“Brantigan”).
`3 Baccelli et al., U.S. Patent Application Publication No. US 2003/0028249
`A1, published February 6, 2003 (Ex. 1008, “Baccelli”).
`4 James L. Berry et al., A Morphometric Study of Human Lumbar and
`Selected Thoracic Vertebrae, 12 SPINE 362–67 (1987) (Ex. 1022, “Berry”).
`5 Michelson, U.S. Patent No. 5,860,973, issued January 19, 1999 (Ex. 1032,
`“Michelson ’973”).
`
`
`
`7
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`
`II. ANALYSIS
`
`A. Estoppel Challenge
`Petitioner states “Patent Owner’s prior positions on Brantigan, Berry,
`and Michelson ’973 are relevant and binding” in this proceeding and implies
`Patent Owner should be estopped from taking contrary positions in this
`proceeding. Pet. 25 (citing Cardpool, Inc. v. Plastic Jungle, Inc., 817 F.3d
`1316, 1323 (Fed. Cir. 2016); Trustees in Bankr. of N. Am. Rubber Thread
`Co. v. United States, 593 F.3d 1346, 1354–56 (Fed. Cir. 2010)).
`Specifically, Petitioner contends Patent Owner relied upon Brantigan and
`Berry in its Petitions for IPR2013-00206 and IPR2013-00208 (Exs. 1014–
`1015) concerning U.S. Patent 8,521,997 (Ex. 1021 or “Michelson ’997”),
`which is a parent of Michelson ’973 (Ex. 1032). Id. at 22. Petitioner quotes
`from statements in the Petition of IPR2013-00206 related to Brantigan (id. at
`23–24) and states “[u]sing the understanding that as it pertains to spinal
`fusion implants, length is measured laterally, ‘consistent with the direction
`of the insertion, from the “insertion end” to the “trailing end,”’ the Federal
`Circuit affirmed.” Id. at 24 (citing Ex. 1019, 5, 7, 9–10). Petitioner also
`contends Patent Owner told the Federal Circuit that several references,
`including Brantigan, disclose lateral insertion. Id. at 24–25 (citing Ex. 1035,
`15). Petitioner asserts that Patent Owner presented evidence of “Berry
`showing [the] state of art.” Id. at 24 (citing Ex. 1016, 15; Ex. 1047, 14–15);
`see id. at 25 (citing Ex. 1035, 43; Ex. 1022, 3646). Petitioner further states
`Patent Owner appealed a jury verdict of no invalidity of Michelson ’997
`
`
`6 We refer to the actual pagination of the underlying document.
`
`
`
`8
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`under a higher standard of review. Id. at 24 (citing Ex. 1035, 14, 27; Ex.
`1046, 2, 5–7).
`Patent Owner contends judicial estoppel does not apply in this
`proceeding. PO Resp. 44. Patent Owner argues that the issues are different.
`Id. Patent Owner asserts the Federal Circuit found that (1) the claims in
`Michelson ’997 do not require Brantigan’s implants to extend to the
`apophyseal ring or beyond a vertebral body’s central region (id. (citing Ex.
`1019, 6–7)); and (2) they need not determine whether Brantigan discloses a
`lateral approach (id. (citing Ex. 1019, 9). Patent Owner further argues its
`position is consistent with that taken in the prior proceeding, which included
`that laterally-inserted implants in Brantigan should occupy substantially—
`not entirely—the transverse width of a vertebra so as to fit within the
`annulus fibrosis. Id. at 45–46 (reproducing annotated Figure 10 of Brantigan
`found in Ex. 1015, 29) (citing Ex. 1019, 197; Ex. 1007, 2:26–28, 2:63–64,
`6:25–32, 6:61, Fig. 11; Ex. 2055 ¶¶ 51–53; Ex. 2057 ¶¶ 21–26). Citing to
`Trustees in Bankr. of N. Am. Rubber Thread Co., Patent Owner argues
`Petitioner has not shown Patent Owner “succeeded in maintaining a position
`that is contrary to its positions herein, that any alleged change in position is
`premised only on an alleged changed interests, or that Petitioners qualify as
`a party that ‘acquiesced in the position formerly taken.’” Id. at 44.
`Having considered the parties’ arguments and cited evidence, we
`agree with Patent Owner (see PO Resp. 44) that the issues in the proceedings
`noted by Petitioner are not relevant to the instant proceeding. For example,
`this proceeding concerns the ’156 patent, whereas IPR2013-00206 and
`
`
`7 We located the figure in Exhibit 1015, 29.
`
`
`
`9
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`IPR2013-00208 (Exs. 1014–1015) concern U.S. Patent 8,521,997 (Ex. 1021)
`or Michelson ’997. Also, the ’156 patent’s claims and specification differ
`from those in Michelson ’997. Compare Ex. 1001, with Ex. 1021.
`Thus, we are not persuaded that Patent Owner’s statements made
`concerning Michelson ’997 and its claims in IPR2013-00206 and IPR2013-
`00208 (Exs. 1014–1015, 1047) or in its briefing to the Federal Circuit (Ex.
`1035) or the Federal Circuit decision (Ex. 1019) related to IPR2013-00206
`and IPR2013-00208 should be binding on Patent Owner in this proceeding
`concerning the ’156 patent. Similarly, cited Exhibit 1046 (Pet. 24) is a
`Federal Circuit opinion concerning patents (e.g., Michelson ’973) other than
`the ’156 patent. Granted, the Federal Circuit discusses Brantigan (Ex. 1007)
`in the opinion. See Ex. 1046, 6–7. But, the record’s evidence differs from
`this proceeding, and Petitioner has not identified any pertinent binding
`statements made by Patent Owner in the opinion related to Brantigan or the
`’156 patent. See Pet. 24 (stating only “Patent Owner unsuccessfully
`appealed a jury verdict of no invalidity of Michelson ’973 under a higher
`clear error standard”) (citing Ex. 1046, 2, 5–7).
`Also, Petitioner has not persuasively shown that Patent Owner’s
`position in this proceeding is clearly inconsistent with a position taken in the
`noted proceedings or that Patent Owner succeeded in maintaining such a
`position. See Trustees in Bankr. of N. Am. Rubber Thread Co., 593 F.3d at
`1353–54. For example, Petitioner asserts that Patent Owner has taken a
`position asserting the “length is measured laterally” and “consistent with the
`direction of insertion, from the ‘insertion end’ to the ‘trailing end.’” Pet. 24.
`However, the Federal Circuit decision arrived at their understanding of
`“length” based on Michelson ’997’s claim 1 itself. Ex. 1019, 5 (citing Ex.
`
`
`
`10
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`1021, 23:24–26 (claim 1). Moreover, the quoted passage from the Federal
`Circuit opinion (Pet. 24) concerns Warsaw’s, not Patent Owner’s, argument
`related to Brantigan. See id. (citing Ex. 1019, 9) (stating “the record belies
`Warsaw’s argument that the Brantigan implants were not designed for lateral
`implantation) (emphasis added).
`Additionally, Patent Owner in this proceeding discusses inserting
`Brantigan’s implant laterally. See PO Resp. 24 (stating “laterally-inserted
`Brantigan implant.”) We thus agree with Patent Owner that any purported
`discussion to the Federal Circuit concerning “several references . . . disclose
`lateral insertion” (Pet. 24 (quoting Ex. 1035, 15)) is consistent with Patent
`Owner’s present position. See PO Resp. 45.
`As for Berry, Petitioner does not explain sufficiently what prior
`position taken by Patent Owner concerning this reference is “relevant and
`binding.” Pet. 25; see id. at 22–25. At best, Patent Owner cites Exhibit
`1016, stating “Berry show[s the] state of art in 1995.” Id. at 24 (citing Ex.
`1016, 15). Although Exhibit 1016 is a document submitted by Patent Owner
`in IPR2013-00206, the cited portion does not appear to discuss Berry and
`only states “sequential dilation was already well known before 1995.” Ex.
`1016, 15.
`Based on the record, Petitioner has not established Patent Owner is
`estopped from taking any specific position in this proceeding.
`B. Level of Ordinary Skill in the Art
`Petitioner asserts that one of ordinary skill in the art “‘would have a
`medical degree with two to three years’ experience performing procedures
`using interbody spinal fusion implants’” or “would have a mechanical or
`biomechanical engineering degree with at least two years’ experience
`
`
`
`11
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`working in developing implant devices and associated instruments with
`significant access to orthopedic surgeons or neurosurgeons.’” Pet. 28
`(quoting Ex. 1002 ¶ 18). Patent Owner does not assert different
`qualifications for a person of ordinary skill in the art (“POSA”). See PO
`Resp. 9. However, Patent Owner contends “a POSA would not be familiar
`with developments in the art that came after the relevant time, such as
`XLIF.”8 Id.
`Our analysis below does not hinge on whether a POSA would be
`familiar with XLIF technology or developments in the art that would have
`come after the relevant time. As such, we adopt Petitioner’s unchallenged
`assessment of the qualifications as the level of ordinary skill in the art.
`Dr. Branch, Petitioner’s expert, has completed residencies and a
`fellowship in neurosurgery departments between 1985–1987, has taught
`spinal surgery since 1987, focusing his practice and research on spinal
`diseases and injuries (e.g., minimally invasive lumbar interbody fusion
`techniques), and has obtained various patents related to spinal surgery,
`spinal implants, and spinal surgical instrumentation. Ex. 1002 ¶¶ 5–13; Ex.
`1003. Dr. Branch’s qualifications are sufficient as a person of skill in the art
`for purposes of this proceeding.
`Dr. Youssef, Patent Owner’s expert, is an orthopedic surgeon, has
`been a practicing spine surgeon for over two decades, including treating
`spinal injuries and performing spine surgery, is a member or fellow of
`various organizations related to surgery, orthopedics, and the spine, has
`written articles related to the spine, treatments, and surgery, and is a named
`
`
`8 eXtreme Lateral Interbody Fusion (XLIF) technology. Ex. 2013 ¶ 1.
`
`
`
`12
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`inventor on patents related to spine implants and fixations systems. Ex.
`2055 ¶¶ 1–12; Ex. 2056. Dr. McMillin, another of Patent Owner’s experts,
`has a B.S. in mechanical engineering and Ph.D. in Macromolecular Science,
`has experience in the field of biomedical engineering beginning in 1974,
`including designing orthopedic products for the spine, and has served on
`various committees or advisory boards in the biomedical industry. Ex. 2057
`¶¶ 1–7; Ex. 2058. Both, Dr. Branch’s and Dr. McMillin’s qualifications are
`sufficient as persons of skill in the art for purposes of this proceeding.
`C. Claim Construction
`On October 11, 2018, the Office revised its rules to harmonize the
`Board’s claim construction standard with that used in federal district court.
`Changes to the Claim Construction Standard for Interpreting Claims in Trial
`Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340
`(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)). This Petition was
`filed after the effective date of the rule change, November 13, 2018, so we
`apply Phillips-type9 claim construction here. Id.; see Pet. 26 (stating that the
`“Board applies ‘the standard used in federal courts . . . ’” (quoting 83 Fed.
`Reg. at 51,343)); Paper 5, 1 (according filing date of December 13, 2018 to
`the Petition).
`Petitioner stated in the Petition that each term “should be given its
`plain and ordinary meaning” and that “no express construction is needed to
`resolve the issues in this Petition.” Pet. 26. Patent Owner presented a claim
`construction for the phrases “longitudinal length,” “medial plane,” and
`
`
`9 Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005).
`
`
`
`13
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`“position proximate to said medial plane.” Prelim. 8–10. We preliminarily
`construed each of these terms in the Decision to Institute based on the record
`then before us. Dec. Inst. 13–14. In its Response and Sur-reply, Patent
`Owner contends Petitioner relies on “unconventional meanings” (PO Resp.
`4) for the phrases “longitudinal length” and “medial plane” that ignore their
`plain meanings. Id. at 3–9; see Sur-reply 2–3. Petitioner responds,
`reiterating what was stated regarding the phrases “longitudinal length” and
`“medial plane” in the Decision to Institute. Reply 5–6 (citing Dec. Inst. 13–
`14).
`
`1. “Longitudinal Length”
`Claim 1 recites “said implant has a longitudinal length extending from
`a proximal end of said proximal wall to a distal end of said distal wall.” Ex.
`1001, 12:45–47.
`In the Decision to Institute (“Dec. Inst.”), we determined
`no express construction is required for [“longitudinal length”]
`other than that required under the express language of claim 1,
`which is: “a longitudinal length” “extend[s] from a proximal
`end of said proximal wall to a distal end of said distal wall”
`where “said longitudinal length is greater than said maximum
`lateral width.” Ex. 1001, 12:45–47, 50–51.
`
`Dec. Inst. 13.
`
`In its Response, Patent Owner contends that “longitudinal length”
`means “the longest dimension.” PO Resp. 5; see id. at 4–8 (citing Ex. 1001,
`2:17–21, Fig. 2; Ex. 1007, 4:15–22, Fig. 1; Ex. 1040 ¶¶ 147, 159, Figs. 55,
`63; Ex. 2022, 51:11–17, 76:7–12, 88:5–13, 89:15–22 (Branch Deposition);
`Ex. 2055 ¶¶ 31–34; Ex. 2023, 120410; Exs. 2009, 2024–2027).
`
`
`10 We refer to the original pagination here.
`
`
`
`14
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`As discussed in the Decision to Institute (Dec. Inst. 13), claim 1
`
`requires that the “longitudinal length is greater than said maximum lateral
`width.” See Ex. 1001, 12:50–51. The requirement that the longitudinal
`length is greater than the width is consistent with the plain and ordinary
`meaning of the term. Considering the entire record, the evidence amply
`supports the plain and ordinary understanding for “longitudinal length” as a
`dimension that is the longer dimension of an object.
`First, although the ’156 patent does not use the term “longitudinal”
`other than in the claims, it describes an implant having a width between 9
`and 18 mm and a length ranging between 25 and 45 mm. Ex. 1001, 2:17–
`21. Figures 2 and 3 of the ’156 patent also show an implant having one
`dimension longer (e.g., from left to right in Figure 3) than another dimension
`(e.g., from bottom to top in Figure 3). See id., Figs. 2–3. Second, as Dr.
`Youssef testifies, other patents use the term “longitudinal” in the context of
`an implant’s length or longer dimension. See Ex. 2055 ¶¶ 33–34 (citing Ex.
`1007, 4:15–16, Fig. 1 (describing “ridges 12 are formed longitudinally
`across the end faces 11c”); Ex. 1040 ¶¶ 147 (describing “implant 1000 has
`an axis C extending through its center longitudinally”), 159, Fig. 55). Third,
`one definition of “longitudinal” includes “[p]arallel to the long axis of the
`body or part” (Ex. 202311, 1204), and one definition of “length” includes
`“the longer or longest dimension of an object.”12 Other provided medical
`dictionaries further support that “longitudinal” means “pertaining to a
`
`
`11 Longitudinal, Taber’s Cyclopedic Medical Dictionary (2001).
`12 Length, The Merriam-Webster Online Dictionary, available at
`https://www.merriam-webster.com/dictionary/length (def. 1a) (last visited
`June 1, 2020).
`
`
`
`15
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`measurement in the direction of the long axis of an object, body, or organ”
`(Ex. 202413, 1020; see also Exs. 2026–2027) or “[r]unning lengthwise” (Ex.
`202514, 995; see also Exs. 2009, 2026–2027). Fourth, Patent Owner’s
`expert, Dr. Youssef, testifies “that the plain and ordinary meaning of the
`term longitudinal length is the longest dimension of the object. For the
`implant, the longitudinal length is the longest dimension of the implant.”
`Ex. 2055 ¶ 32 (citing Ex. 1001, 12:44–64); see id. ¶¶ 33–34.
`
`In contrast, Petitioner’s expert, Dr. Branch, appears to use a
`“‘convention’ [that] is inconsistent with the plain meaning” (PO Resp. 6–7)
`of longitudinal length. See id. at 4–7 (citing Ex. 2022, 51:11–17, 52:5–56:9,
`76:7–12, 88:5–13, 89:15–22, 114:3–19, 116:4–15, 117:3–4); see also Sur-
`reply 2–3 (citing Ex. 2022, 52:5–56:9, 114:3–19, 116:4–14, 117:2). Only as
`part of his testimony in support of obviousness does Dr. Branch testify that a
`person of ordinary skill in the art would have understood Brantigan’s
`implants to “have a longitudinal length that is measured relative to the
`direction in which it is inserted from the proximal end that contains the tool
`receiving recess or mechanism to the distal end opposite the insertion end.”
`Ex. 1002 ¶ 122 (emphasis added). Similarly, Dr. Branch had the following
`dialogue related to his convention:
`Q. And in this case, the 22 millimeter depth refers to the longest
`length of the implant, correct?
`A. Correct.
`
`
`
`13 Longitudinal, Mosby’s Medical, Nursing, & Allied Health Dictionary
`(2002). We refer to the original pagination.
`14 Longitudinal, PDR® Medical Dictionary (1995). We refer to the original
`pagination.
`
`
`
`16
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`
`Q. And you are saying that that longest length of the implant is
`the longitudinal length of the implant?
`A. If we -- if we used the convention, which is proximal end is
`where the inserter is and the distal end is the leading end or the
`end that is furthest away from the inserter, then this term depth
`is equivalent to longitudinal length.
`
`Q. If the -- if the inserter for this implant was positioned in the
`middle of its longest dimension, is it your opinion that the
`longitudinal length of the implant would be the 8 millimeter
`width?
`A. By convention, the length is from the -- where the inserter
`attaches to the device. So if this device actually had an insertion
`or configuration that the inserter handle came in perpendicular
`to the -- what we see here is the longitudinal -- and came in
`perpendicular to this, attach and inserted it that way, then by
`convention the length would be this shorter distance and the
`width would be the longer distance.
`
`Q. And the shorter distance would be what you would call the
`longitudinal length?
`A. Correct.
`
`
`Ex. 2022, 53:22–54:24.
`Dr. Branch’s interpretation of “longitudinal length” is inconsistent
`with the claim language and has no support in the Specification. The record
`also has inadequate support for Dr. Branch’s interpretation. See Ex. 1002
`¶ 122; 37 C.F.R. § 42.65(a). On the other hand, Dr. Youssef’s testimony, as
`discussed above, (1) provides support for and explanation why the plain and
`ordinary meaning of the term should be used (see Ex. 2055 ¶¶ 31–34) and
`(2) is consistent with (a) the claim language itself, (b) the Specification, (c)
`other references in the same field of art, and (d) an ordinarily skilled
`artisan’s understanding.
`
`
`
`17
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`
`Based on the entire record, we determine “longitudinal length” means
`an object’s longer dimension. In the context of claim 1, we further
`determine “a longitudinal length” is the implant’s longer dimension
`“extending from a proximal end of said proximal wall to a distal end of the
`said distal wall” and “is greater than said [implant’s] maximum lateral
`width.” Ex. 1001, 12:45–47, 12:50–51.
`2. “Medial Plane” and “Proximate to Said Medial Plane”
`Claim 1 also recites “a medial plane that is generally perpendicular to
`said longitudinal length” and “a position proximate to said medial plane.”
`Ex. 1001, 12:49–50, 12:65, 12:67.
`In the Decision to Institute, we preliminarily determined “in the
`context of claim 1, the ‘medial plane’ is located approximately at the
`midpoint of the longitudinal length.” See Ex. 1033, 8; see Ex. 2010, 215[];
`see Prelim. Resp. 9 (citing Ex. 1033; Ex. 2010).” Dec. Inst. 14 (omitting
`footnote 5 referring to NuVasive, Inc. v. Alphatec Holdings, Inc., Case No.
`3:18-cv-00347-CABMDD (S.D. Cal.), App’x B1, Joint Claim Construction
`Worksheet).
`In its Response, Patent Owner agrees with our construction. PO Resp.
`8 (citing Dec. Inst. 14). Dr. Youssef also states “it is my opinion that the
`plain and ordinary meaning of term ‘medial’ refers to the middle or midpoint
`of an object” “[b]ased on [his] knowledge and years of experience as a spine
`surgeon.” Ex. 2022 ¶ 35. Petitioner reiterates our determination in the
`Decision to Institute. Reply 5–6. Upon review of the entire record, we
`determine that the “medial plane” in the context of claim 1 is located
`approximately at the midpoint of the longitudinal length consistent with our
`understanding of “longitudinal length” discussed in Section II.C.1.
`
`
`
`18
`
`
`
`IPR2019-00362
`Patent 8,361,156 B2
`
`
`In the Decision to Institute, we further determined the term
`“proximate” within the phrase “a position proximate said medial plane”
`means “near.” Dec. Inst. 14 (citing Prelim. Resp. 10; Ex. 2009, 6).
`Other than quoting from the Decision to Institute determining that the
`“‘medial plane’ is located approximately at the midpoint of the longitudinal
`length” (PO Resp. 9 (quoting Dec. Inst. 14)), Patent Owner provides no
`arguments related to the term “proximate” and our construction. See id. at
`8–9. Petitioner reiterates our determination in the Decision to Institute.
`Reply 5–6. Upon review of the entire record, we determine that the term
`“proximate” means “near” and that the phrase “proximate to said medial
`plane” means near or approximately at the midpoint of the longitudinal
`length consistent with our understanding of “longitudinal length” discussed
`in Section II.C.1.
`3. Other Terms
`Although Patent Owner proposes the construction of additional claim
`terms (PO Resp. 4–9), we determine that it is not necessary to provide an
`express interpretation of any other term of the claims because it is not
`necessary to resolve any issue or dispute. Vivid Techs., Inc. v. Am. Sci. &
`Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (construing explicitly only
`those claim terms in controversy and only 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).
`D. Legal Standards
`A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
`differences between the c
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
