`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`GLOBUS MEDICAL, INC.,
`
`
`Plaintiff,
`
`
`
`v.
`
`
`LIFE SPINE, INC.,
`
`
`
`
`
`
`C.A. No. 21-1445 (JPM)
`
`
`
`)))))))))
`
`
`
`Defendant.
`
`
`DEFENDANT LIFE SPINE, INC.’S OPENING CLAIM CONSTRUCTION BRIEF
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`Jack B. Blumenfeld (#1014)
`Jennifer Ying (#5550)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`jying@morrisnichols.com
`
`Attorneys for Defendant
`
`
`
`
`OF COUNSEL:
`
`Brianne M. Straka
`Dave A. Nelson
`Rajat Khanna
`Jonathon Studer
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`191 North Wacker Drive, Suite 2700
`Chicago, IL 60606
`(312) 705-7400
`
`Isabel Peraza
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`1300 I Street NW
`Suite 900
`Washington, D.C. 20005
`(202) 538-8000
`
`November 10, 2022
`
`
`
`
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`Case 1:21-cv-01445-JPM Document 80 Filed 11/10/22 Page 2 of 16 PageID #: 1871
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`TABLE OF CONTENTS
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`Page
`
`INTRODUCTION ...............................................................................................................1
`BACKGROUND OF THE PURPORTED INVENTIONS .................................................1
`LEGAL PRINCIPLES .........................................................................................................4
`THE PROPER CONSTRUCTION OF “ELONGATE FIN”...............................................5
`A.
`Intrinsic Evidence ....................................................................................................5
`B.
`Extrinsic Evidence ...................................................................................................8
`C.
`Globus’s Overbroad Position ...................................................................................9
`CONCLUSION ....................................................................................................................9
`
`
`
`I.
`II.
`III.
`IV.
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`V.
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`i
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`Case 1:21-cv-01445-JPM Document 80 Filed 11/10/22 Page 3 of 16 PageID #: 1872
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`TABLE OF AUTHORITIES
`
`Cases
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`Page
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`Hon Hai Precision Indus. Co. v. PSC Computer Prod., Inc.,
`2003 WL 25902414 (C.D. Cal. Aug. 6, 2003) ...........................................................................9
`
`Markman v. Westview Instruments, Inc.,
`517 U.S. 370 (1996) ...................................................................................................................4
`
`O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., Ltd.,
`521 F.3d 1351 (Fed. Cir. 2008)..................................................................................................4
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005)..............................................................................................4, 5
`
`
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`ii
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`Case 1:21-cv-01445-JPM Document 80 Filed 11/10/22 Page 4 of 16 PageID #: 1873
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`TABLE OF EXHIBITS
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`No.
`1
`2
`3
`4
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`5
`6
`7
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`8
`9
`10
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`Description
`U.S. Patent No. 11,065,128 to Zappacosta et al.
`Certified Translation of Korean Patent No. 20-0290058 to Chung
`U.S. Patent No. 5,306,308 to Gross et al.
`Virk et al., “History of Spinal Fusion: Where We Came from and Where We Are
`Going,” (2020) HSS Journal, 16:137-142
`U.S. Publication No. 2011/0230971 to Donner et al.
`U.S. Publication No. 2013/0150968 to Dinville at al.
`U.S. Patent Application No. 15/962,174, November 30, 2020 Applicant
`Arguments Made in Amendment
`Excerpts from New Oxford Dictionary (3d ed. 2010)
`Excerpts from Cambridge Advanced Learner’s Dictionary (4th ed. 2013)
`Excerpts from Chambers Dictionary (12th ed. 2011)
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`
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`iii
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`Case 1:21-cv-01445-JPM Document 80 Filed 11/10/22 Page 5 of 16 PageID #: 1874
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`Claim Term
`“the actuator assembly
`comprises”
`“expansion portion”
`
`TABLE OF AGREED CONSTRUCTIONS
`
`Patent(s)
`U.S. 8,845,731
`
`Agreed Construction
`“the actuator member comprises”
`
`U.S. 10,925,752 “a portion with an angled surface that facilitates
`expansion”1
`
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`TABLE OF DISPUTED TERMS AND PROPOSED CONSTRUCTIONS
`
`Claim Term
`“elongate fin”
`
`Patent(s)
`U.S. 11,065,128
`
`
`
`
`Life Spine’s Construction Globus’s Construction
`“a protrusion extending
`“a generally flat protrusion
`from the elongate
`extending from the elongate
`shank”
`shank”
`
`
`1 Life Spine agreed to this construction based, in part, on Globus’s representation that it does not
`interpret “angled surface” differently from “ramped surface.”
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`
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`iv
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`Case 1:21-cv-01445-JPM Document 80 Filed 11/10/22 Page 6 of 16 PageID #: 1875
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`
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`I.
`
`INTRODUCTION
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`The eight asserted patents in this case are all directed to narrow claims in the crowded
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`field of intervertebral implants. The parties have identified a claim construction dispute as to a
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`single claim term in U.S. Patent 11,065,128 (the “’128 patent”), which involves a curved bone
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`anchor with an “elongate fin.” Life Spine’s proposed construction is clear from the intrinsic
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`evidence and the plain meaning of “elongate” and “fin.” On the other hand, Globus offers a
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`construction that is divorced from the intrinsic and extrinsic evidence. Life Spine respectfully
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`asks the Court to adopt its proposed construction.
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`II.
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`BACKGROUND OF THE PURPORTED INVENTIONS
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`The asserted patents, including the ’128 patent, relate to intervertebral (spinal) fusion
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`implants. The human spine comprises bones called “vertebrae,” which are generally not fused
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`together. Ex. 2 at 3. These vertebrae are separated by soft, cushion-like structures known as
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`“intervertebral discs” that act like shock absorbers. Because intervertebral discs are under
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`constant pressure from the vertebrae around them, they can become herniated or torn, causing
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`extreme pain and other health issues. Spinal implants are used to treat these conditions by
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`restoring the spacing between vertebrae, ’128 patent at 1:27-30, and have been well-known since
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`at least the 1980s. Ex. 3; Ex. 4.
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`Spinal fusion implants, which are the subject of the asserted patents, are used in common
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`medical procedures for treating pain associated with intervertebral discs that have degenerated
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`due to trauma or aging. Intervertebral fusion implants are used to fuse one or more adjacent
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`vertebral bodies. ’128 patent at 1:21-25. Typically, to fuse the adjacent vertebral bodies, an
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`intervertebral disc is first partially or fully removed. Id. at 1:25-27. An intervertebral spacer or
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`fusion device is then inserted between neighboring vertebrae to maintain normal disc spacing
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`and restore spinal stability, thereby facilitating an intervertebral fusion. Id. at 1:27-30.
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`1
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`Case 1:21-cv-01445-JPM Document 80 Filed 11/10/22 Page 7 of 16 PageID #: 1876
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`
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`The ’128 patent claims are directed to intervertebral spacer systems comprising an
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`intervertebral spacer with bores and a curved bone anchor. The spacer is placed between
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`vertebra. The curved bone anchor is inserted through the spacer’s bores into bone to secure the
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`spacer to a vertebra. ’128 patent at 5:57-61. The curved bone anchor has an “elongate fin,” much
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`like a shark fin, or the fins on a surfboard or airplane, but elongated to stretch across the bone
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`anchor. Figure 33 from the ’128 patent depicts this “elongate fin” (labeled 310 and shaded teal):
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`’128 patent, Fig. 33 (annotated). As can be seen in the figure above, the claimed structure is a
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`
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`generally flat protrusion (like a shark’s fin or a ship’s sail), extending out from and elongated to
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`run along the length of the “elongate shank” 308.
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`Representative claim 1 is reproduced below with the term “elongate fin” emphasized:
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`1. An intervertebral spacer system, comprising:
`
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`an intervertebral spacer comprising a spacer portion and a plate
`portion, the plate portion including at least one bore configured
`and dimensioned to receive a vertebral anchor;
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`
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`the vertebral anchor comprising:
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`a head portion that is at least partially spherical;
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`2
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`Case 1:21-cv-01445-JPM Document 80 Filed 11/10/22 Page 8 of 16 PageID #: 1877
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`
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`an elongate shank extending from the head portion; and
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`an elongate fin extending from the head portion and along
`a surface of the elongate shank, the elongate shank and the
`elongate fin disposed generally perpendicular to each
`other,
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`wherein the elongate shank is curvilinear,
`
`wherein the elongate fin extends from the head portion to
`an apex of the elongate shank, the apex being defined as the
`most distal point of the vertebral anchor such that the most
`distal point of both the elongate fin and the elongate shank
`meet at the apex, wherein the apex is configured to be a
`point that first impacts bone by the vertebral anchor.
`
`
`’128 patent, claim 1 (emphasis added).
`
`Spacers with curved (curvilinear) anchors, such as those discussed in the ’128 patent,
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`were well-known and described in the art. Ex. 5; Ex. 6. These curved anchors allow for
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`“insertion into irregular or curved portions of the spine,” such as “at the most caudal or most
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`cephalad cervical disc spaces or caudal lumbar levels.” Ex. 1 at 1:43-45. To prevent movement
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`by implant devices, bone anchors have been long used to “solidly attach[] the implant to the
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`adjacent vertebrae between which it is implanted.” Ex. 6 at [0002]. However, the curvature of
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`the spine can obstruct the passageway or placement of “linear line-of-approach” anchors, such as
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`a straight screw. Ex. 5 at [0003]. Curved anchors are designed to be used in such situations. Id.
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`at [0003]-[0004].
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`What is allegedly novel about the ’128 patent is that the “elongate fin” extends all the
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`way to the anchor’s apex, i.e., the point which first impacts bone. In an attempt to avoid the
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`prior art, Globus amended its claims to recite that the elongate fin stretched along the very apex
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`of the vertebral anchor:
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`3
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`Case 1:21-cv-01445-JPM Document 80 Filed 11/10/22 Page 9 of 16 PageID #: 1878
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`Ex. 7 at 7. Globus illustrated this concept, distinguishing the prior art as shown below:
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`Id. at 8.
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`III. LEGAL PRINCIPLES
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`“[T]he claims of a patent define the invention to which the patentee is entitled the right to
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`exclude.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005). Courts, as a matter of
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`law, must construe the claims of a patent in order to ascertain precisely what it is that is patented.
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`Id.; see also Markman v. Westview Instruments, Inc., 517 U.S. 370, 387 (1996). “When the
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`parties raise an actual dispute regarding the proper scope of these claims, the court, not the jury,
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`must resolve that dispute.” O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., Ltd., 521 F.3d
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`1351, 1360 (Fed. Cir. 2008).
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`
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`4
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`Case 1:21-cv-01445-JPM Document 80 Filed 11/10/22 Page 10 of 16 PageID #: 1879
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`
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`“[T]he words of a claim are generally given their ordinary and customary meaning,”
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`which “is the meaning that the term would have to a person of ordinary skill in the art in question
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`at the time of the invention,” when read “in the context of the entire patent.” Phillips, 415 F.3d
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`at 1312-13. When construing claims, courts should first look to the intrinsic evidence: the
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`claims, specification, and prosecution history. Phillips, 415 F.3d 1314-16. The specification is
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`“the single best guide to the meaning of a disputed term” and may “reveal a special definition
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`given to a claim term by the patentee that differs from the meaning it would otherwise possess.”
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`Phillips, 415 F.3d at 1315-16. The prosecution history also “can often inform the meaning of the
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`claim language by demonstrating how the inventor understood the invention and whether the
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`inventor limited the invention in the course of prosecution.” Id. at 1317. Extrinsic evidence,
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`such as dictionaries and expert testimony, may also be considered for purposes of claim
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`construction, although it is generally “less reliable than the patent and its prosecution history.”
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`Id. at 1318.
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`IV.
`
`THE PROPER CONSTRUCTION OF “ELONGATE FIN”
`
`Life Spine’s Construction
`“a generally flat protrusion
`extending from the elongate shank”
`
`Globus’s Construction
`“a protrusion extending from the
`elongate shank”
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`As explained below, the intrinsic and extrinsic evidence provide that an “elongate fin” is
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`
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`a generally flat (or flattened) protrusion extending from the elongate shank.
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`A.
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`Intrinsic Evidence
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`Without exception, the ’128 patent specification describes the claimed “elongate fin” as a
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`generally flat protrusion extending from the “elongate shank.” Importantly, all of the patent’s
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`references to “elongate fin” point to either item 310 of the anchor depicted in Figures 29-36 or
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`the “elongate fin” of the anchor depicted in Figures 37-40. See ’128 patent at 7:62-8:3, 12:21-
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`28, 13:53-65, 14:4-13. For example, consider the “elongate fin” of the vertebral anchor
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`5
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`Case 1:21-cv-01445-JPM Document 80 Filed 11/10/22 Page 11 of 16 PageID #: 1880
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`
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`represented in Figures 29-36.2 Figure 33, in particular, provides a clear view showing that the
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`“elongate fin” (310) (shaded teal) extends from and along the “elongate shank” (308) and is
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`generally flat or flattened as shown by the red arrows.
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`
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`’128 patent, Fig 33 (annotated). Depictions of the other embodiment of a vertebral anchor, in
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`Figures 37-403, illustrate the same defining characteristics. The “elongate fin” (shaded teal) is
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`generally flat or flattened—as shown by the red arrows—and extends from the “elongate shank”
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`(408).
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`2 Figures 30-36 are different perspectives of the anchor in Figure 29. See ’128 patent at 2:26-42.
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`3 Figures 37-40 are identified as various views of “another exemplary vertebral anchor in
`accordance with an example of the present disclosure.” ’128 patent at 2:43-45.
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`6
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`Case 1:21-cv-01445-JPM Document 80 Filed 11/10/22 Page 12 of 16 PageID #: 1881
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`
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`’128 patent, Figs. 37-38 (annotated).
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`This is only further confirmed by the prosecution history. In response to the Examiner’s
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`rejection, Globus distinguished prior art during prosecution on the basis that the prior art did not
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`include a fin that ran all the way to the apex of the anchor or shank:
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`7
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`Case 1:21-cv-01445-JPM Document 80 Filed 11/10/22 Page 13 of 16 PageID #: 1882
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`
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`Ex. 7 at 8. Put another way, throughout the intrinsic record, the claimed “elongate fin” is always
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`a generally flat protrusion extending out from the anchor shank and elongated to run along the
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`shank to its apex.4
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`B.
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`Extrinsic Evidence
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`Contemporaneous dictionaries confirm that the term “elongate fin” means a generally flat
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`protrusion extending from the elongate shank (or body) of the anchor.
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`The term “fin” is well-understood in the context of fish, planes, surfboards, radiators, and
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`the like. In those contexts, “fin,” even standing alone, connotes a generally flat, flattened, or thin
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`protrusion extending from a body. See, e.g., Ex. 8 (a “fin” is a “flattened appendage on various
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`parts of the body of many aquatic vertebrates” or “a small flattened projecting surface or
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`attachment on an aircraft, rocket, or automobile . . . .” or “a flattened projection on a device”)
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`(emphasis added); Ex. 9 (a “fin” is “a thin vertical part sticking out of the body of especially a
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`fish or an aircraft which helps balance and movement”) (emphasis added); Ex. 10 (a “fin” is “an
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`organ by which an aquatic animal steers, balances or swims; a swimmer’s flipper; a fixed vertical
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`surface on the tail of an aeroplane; a portion of a mechanism like a fish’s fin in shape or purpose;
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`a thin projecting edge or plate; a hand or arm”) (emphasis added).
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`The presence of “elongate” before fin further emphasizes the flattened nature of a fin, i.e.,
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`the length of the fin is extenuated relative to its width. See Ex. 8 (“elongate” means “make
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`something longer, esp. unusually so in relation to its width” and “elongated” means “unusually
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`long in relation to its width”); Ex. 9 (“elongate” means “to become or make something become
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`longer, and often thinner” and “elongated” means “longer and thinner than usual”); Ex. 10
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`(“elongate” means “adj long and narrow”).
`
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`4 The requirement that the “elongate fin” run to the apex is explicit in the independent claims.
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`8
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`Case 1:21-cv-01445-JPM Document 80 Filed 11/10/22 Page 14 of 16 PageID #: 1883
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`
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`In sum, these dictionaries confirm that a “fin” is a generally flat or flattened protrusion
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`from a body or device and that “elongate” emphasizes the fin’s length compared to its width.
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`Because this teaching is consistent with the intrinsic evidence, particularly the ’128 patent’s
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`illustrations of “elongate fins” as generally flat or flattened protrusions, Life Spine’s proposed
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`construction should be adopted. Cf. Hon Hai Precision Indus. Co. v. PSC Computer Prod., Inc.,
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`2003 WL 25902414, at *7 (C.D. Cal. Aug. 6, 2003) (in context of heat sinks, defining “fins” as
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`“flattened projections used to increase heat transfer from an object”).
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`C.
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`Globus’s Overbroad Position
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`While initially Globus declined to take any position on what “elongate fin” means, it has
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`since made it clear that, in its view, “elongate fin” means any protrusion of any shape extending
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`from the “elongate shank.” But as explained above, that is plainly contrary to the intrinsic
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`record, which only discloses a generally flat protrusion extending along the anchor shank.
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`Indeed, the prosecution history shows what Globus believed to be its invention when it sought to
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`avoid the prior art—fins (flat protrusions) extending out from and to the very tip of the vertebral
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`anchor. Nor is Globus’s position tenable based on the well-understood meaning of “fin,” which
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`is a well-known structure and shape. Globus’s overbroad construction should thus be rejected, as
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`it is neither supported by the intrinsic record nor consistent with the plain meaning of “fin.”
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`V.
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`CONCLUSION
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`For the foregoing reasons, Life Spine’s proposed construction should be adopted.
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`9
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`Case 1:21-cv-01445-JPM Document 80 Filed 11/10/22 Page 15 of 16 PageID #: 1884
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Jennifer Ying
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Jennifer Ying (#5550)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`jying@morrisnichols.com
`
`Attorneys for Defendant
`
`
`
`
`
`
`OF COUNSEL:
`
`Brianne M. Straka
`Dave A. Nelson
`Rajat Khanna
`Jonathon Studer
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`191 North Wacker Drive, Suite 2700
`Chicago, IL 60606
`(312) 705-7400
`
`Isabel Peraza
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`1300 I Street NW
`Suite 900
`Washington, D.C. 20005
`(202) 538-8000
`
`November 10, 2022
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`10
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`Case 1:21-cv-01445-JPM Document 80 Filed 11/10/22 Page 16 of 16 PageID #: 1885
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`CERTIFICATE OF SERVICE
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`I hereby certify that on November 10, 2022, I caused the foregoing to be electronically
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`filed with the Clerk of the Court using CM/ECF, which will send notification of such filing to all
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`registered participants.
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`I further certify that I caused copies of the foregoing document to be served on
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`November 10, 2022, upon the following in the manner indicated:
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`Jeffrey S. Cianciulli, Esquire
`WEIR GREENBLATT PIERCE LLP
`824 Market Street Mall, Suite 800
`Wilmington, DE 19801
`Attorneys for Plaintiff
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`Arun S. Subramanian, Esquire
`Jacob Buchdahl, Esquire
`Mark Hatch-Miller, Esquire
`Geng Chen, Esquire
`SUSMAN GODFREY L.L.P.
`1301 Avenue of the Americas, 32nd Floor
`New York, NY 10019
`Attorneys for Plaintiff
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`John P. Lahad, Esquire
`SUSMAN GODFREY L.L.P.
`1000 Louisiana Street, Suite 5100
`Houston, TX 77002-5096
`Attorneys for Plaintiff
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`VIA ELECTRONIC MAIL
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`VIA ELECTRONIC MAIL
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`VIA ELECTRONIC MAIL
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`/s/ Jennifer Ying
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`Jennifer Ying (#5550)
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