Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 11
`Entered: March 7, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`GLOBUS MEDICAL, INC.,
`Petitioner,
`
`v.
`
`FLEXUSPINE, INC.,
`Patent Owner.
`_______________
`
`Case IPR2015-01795
`Patent 8,647,386 B2
`_______________
`
`
`
`Before WILLIAM V. SAINDON, HYUN J. JUNG, and
`TIMOTHY J. GOODSON, Administrative Patent Judges.
`
`
`
`SAINDON, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`Paper 11
`Entered: March 7, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`GLOBUS MEDICAL, INC.,
`Petitioner,
`
`v.
`
`FLEXUSPINE, INC.,
`Patent Owner.
`_______________
`
`Case IPR2015-01795
`Patent 8,647,386 B2
`_______________
`
`
`
`Before WILLIAM V. SAINDON, HYUN J. JUNG, and
`TIMOTHY J. GOODSON, Administrative Patent Judges.
`
`
`
`SAINDON, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`Case IPR2015-01795
`Patent 8,647,386 B2
`
`I. INTRODUCTION
`Petitioner requests an inter partes review of claims 1–4 of U.S. Patent
`No. 8,647,386 B2 (Ex. 1001, “the ’386 patent”). Paper 1 (“Pet.”). Patent
`Owner filed a Preliminary Response to the Petition. Paper 9 (“Prelim.
`Resp.”).
`We have jurisdiction under 35 U.S.C. § 314, which provides that
`an inter partes review may not be instituted “unless . . . there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.” Upon consideration of the Petition, the
`exhibits cited therein, and Patent Owner’s Preliminary Response, we
`institute an inter partes review of all challenged claims.
`Our factual findings and conclusions at this stage of the proceeding
`are based on the evidentiary record developed thus far. This is not a final
`decision as to the patentability of claims for which inter partes review is
`instituted. Our final decision will be based on the record as fully developed
`during trial.
`
`A. Related Matters
`Petitioner represents that it has been accused of infringement of the
`’386 patent in Flexuspine, Inc. v. Globus Medical, Inc., Case 15-cv-00201-
`JRG-KNM (E.D. Tex.). Pet. 2–3; Paper 4, 2. Petitioner also represents that
`it has simultaneously requested inter partes reviews of several other patents
`owned by Patent Owner. Pet. 3.
`
`B. Illustrative Claim
`Independent claim 1 is the sole independent claim challenged by
`Petitioner and is reproduced below.
`
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`Case IPR2015-01795
`Patent 8,647,386 B2
`1. An intervertebral implant system for a human
`spine, comprising:
`a first body comprising:
`
`a first external surface configured to be disposed
`adjacent a first vertebra during use; and
`a first internal surface opposite the first external
`surface;
`a second body comprising:
`
`a second external surface configured to be
`disposed adjacent a second vertebra during use,
`and
`a second internal surface opposite the second
`external surface;
`releasably
`instrument
`an elongated
`insertion
`couplable to the first or second body during use;
`and
`a spacer linearly advanced between the first internal
`surface of the first body and the second internal
`surface of the second body during use, wherein
`the elongated insertion instrument guides at least
`a portion of the linear advancement of the spacer
`after the first and second bodies have been
`disposed substantially between the first and
`second vertebrae from a position remote to the
`first and second bodies during use, and wherein
`the linear advancement of the spacer results in
`expansion of the intervertebral implant such that
`the first external surface and the second external
`surface move away from one another to expand
`a height of the implant.
`
`
`
`C. Prior Art and Asserted Grounds
`Petitioner challenges claims 1–4 under 35 U.S.C. § 103 as
`unpatentable over U.S. Patent No. 6,595,998 B2 to Johnson, issued July 22,
`2003 (Ex. 1004, “Johnson”) and the knowledge of one of ordinary skill in
`
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`Case IPR2015-01795
`Patent 8,647,386 B2
`the art. Pet. 13–49. Petitioner also relies on the testimony of Jorge A.
`Ochoa, Ph.D., P.E. (Ex. 1005).
`
`II. ANALYSIS
`A. Claim Construction
`We interpret the claims of an unexpired patent using the broadest
`reasonable interpretation in light of the specification of the patent. 37 C.F.R.
`§ 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278 (Fed.
`Cir. 2015), cert. granted sub nom. Cuozzo Speed Techs., LLC v. Lee, 84
`U.S.L.W. 3218 (U.S. Jan. 15, 2016) (No. 15-446). Under the broadest
`reasonable interpretation standard, claim terms are given their ordinary and
`customary meaning, as would be understood by one of ordinary skill in the
`art in the context of the entire disclosure. In re Translogic Tech. Inc., 504
`F.3d 1249, 1257 (Fed. Cir. 2007). Any special definition for a claim term
`must be set forth with reasonable clarity, deliberateness, and precision. In re
`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`
`1. “first body”
`Petitioner first argues that the “first body” limitation is a “recitation[]
`of the intended use for the claimed apparatus” and “is not material to
`patentability.” Pet. 18–19. We disagree because the claim is directed to a
`structure—a body—and that body is claimed to have certain features by
`being “configured to be disposed adjacent a first vertebra during use.”
`Although broad, the “configured to” limitation precludes those structures not
`capable of being disposed adjacent a vertebra. See K-2 Corp. v. Salomon
`S.A., 191 F.3d 1356, 1363 (Fed. Cir. 1999) (“the functional language tells us
`
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`Case IPR2015-01795
`Patent 8,647,386 B2
`something about the structural requirements of the attachment between the
`bootie and the base [of an inline skate] . . . .”).
`Petitioner’s alternative argument as to why Johnson teaches this
`limitation, in the event it is given weight, sheds light on Petitioner’s
`interpretation of this limitation. Petitioner argues that a person of ordinary
`skill in the art “would have understood that . . . the wafer columns . . . would
`be supported between the bone surfaces.” Pet. 19. In other words, Petitioner
`is reading the claimed “first body” on the uppermost wafer in the stack of
`wafers depicted in Figure 37 of Johnson. The following annotated version
`of Figure 37 of Johnson illustrates Petitioner’s position:
`
`
`
`Figure 37 of Johnson depicts detachable tip wafer inserter 260,
`wherein wafers 263 are inserted to distract and support tissue, such as
`vertebrae. Ex. 1004, 4:54–65, 17:47–50, 21:26–33. Petitioner has identified
`detachable tip 260 as the claimed second body and wafer 263 as the claimed
`first body. See, e.g., Pet. 20 (noting identifications on annotated figure).
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`Case IPR2015-01795
`Patent 8,647,386 B2
`Accordingly, we understand Petitioner’s position to be that the first body of
`claim 1 is the structure of the implant that is disposed against a vertebra.
`Patent Owner argues that “Johnson is simply a different structural
`arrangement” and that, before the wafers are inserted, “there would be no
`first body having a superior surface arranged adjacent the upper vertebra.”
`Prelim. Resp. 16. Patent Owner also argues that “Petitioner is improperly
`and unreasonably interpreting the claim language by changing the identity of
`the claimed ‘spacer’ each time an additional wafer is inserted.” Id. at 17.
`Accordingly, Patent Owner’s argument appears to be that claim 1 requires
`that the first body not be the same type of structure as the claimed spacer.
`The claims do not describe the structural features of the first body and
`the spacer in detail. The first body is described as having external and
`internal surfaces, with the external surface configured to be disposed
`adjacent a vertebra. The ’386 patent’s specification describes many different
`embodiments having many different configurations. Figures 1–8, for
`example, show structures identified as upper and lower bodies. See, e.g., Ex.
`1001, 13:63–14:8 (describing upper and lower bodies configured in
`particular ways to accommodate an insert). The bodies are described
`generally as interfacing with bone (as is required by claim 1). See, e.g., id.
`at 10:40–51 (describing bodies having surfaces to “reduc[e] the possibility
`of subluxation and/or dislocation”). Figures 9A–9F depict a cage
`embodiment where an insert is pushed out past the cage. Id. at 14:35–58.
`The cage has one or two apertures that permit an insert to move out from the
`cage into contact with the vertebra. Id. The ’386 patent does not describe
`any feature in this embodiment as a “body.” See generally id. at 14:33–
`15:18. Figures 18 and 24A–24E depict a device having two bodies and a
`
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`Case IPR2015-01795
`Patent 8,647,386 B2
`spacer, wherein the spacer acts as a shim to expand the implant. Id. at
`18:27–63. The spacers are described generally as having a fixed size to
`provide a fixed separation distance between upper and lower bodies. See,
`e.g., id. at 18:52–63. The spacers “may have substantially the same shape
`and/or profile as upper body” and may be made “of the same material as an
`implant into which the spacer is to be inserted.” Id. at 18:39–41, 58–61.
`Reviewing the specification, we find little guidance as to what
`structural features are required by a body, aside from the fact that it is a
`portion of the implant designed to interface with bone, but that already is
`recited in claim 1. The bodies in the specification are described generally as
`having features on the interior side conforming to the shape of various
`inserts, e.g., Figures 1–8, but claim 1 does not include an insert and is not
`directed to these embodiments. In embodiments showing a spacer, e.g.,
`Figure 24, the discussion focuses on the spacer, not the body. See generally
`id. at 22:30–23:3. Accordingly, the specification by itself does not appear to
`shed much light on the structural features of a body. In addition, just
`because one series of embodiments has both bodies and a spacer and the
`claim has bodies and a spacer does not mean that we import limitations from
`those embodiments into the claims. Superguide Corp. v. DirecTV Enter.,
`Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (a particular embodiment appearing
`in the written description may not be read into a claim when the claim
`language is broader than the embodiment). Here, claim 1 is broader than
`those embodiments, as it generically recites features of the body and spacer,
`without the level of detail of any particular embodiment.
`We next look to evidence of how a person of ordinary skill in the art
`would understand the term “body” in view of the specification. The record
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`Case IPR2015-01795
`Patent 8,647,386 B2
`before us includes testimony of Dr. Ochoa, who testifies that the “first body”
`limitation reads on the topmost wafer in Johnson, in his opinion. Ex. 1005
`¶ 34.1 Thus, Dr. Ochoa’s testimony provides evidence that a person of
`ordinary skill in the art would understand the term as proposed by Petitioner.
`Lastly, we turn to the prosecution history that Petitioner has brought
`to our attention. Pet. 11. DePuy Spine, Inc. v. Medtronic Sofamor Danek,
`Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (“In determining the meaning of
`the disputed claim limitation, we look principally to the intrinsic evidence of
`record, examining the claim language itself, the written description, and the
`prosecution history, if in evidence.”) (citing Phillips v. AWH Corp., 415 F.3d
`1303, 1312–17 (Fed. Cir. 2005)); Microsoft Corp. v. Proxyconn, Inc., 789
`F.3d 1292, 1298 (Fed. Cir. 2015) (instructing the PTO to consider
`prosecution history in inter partes review). As we mentioned above, the
`embodiments in Figures 9A–9F are among the few that are not described as
`having a body. Notwithstanding, according to the prosecution history, this is
`the embodiment the applicant selected in response to a restriction
`requirement. Ex. 1003, 1515–1517 (applicant electing “Group 10 (Figs.
`9A–9F),” which included corresponding claim 158); id. at 16, 1507, 1740
`(showing allowed claim 158 is claim 1 of the ’386 patent).
`In view of the above and on the present record, we understand the
`term “first body” to be a structural element having the claimed features of an
`external surface configured to be adjacent a first vertebra and an internal
`surface opposite the first surface.
`
`
`1 Dr. Ochoa, however, does not provide an explicit analysis of how a person
`of ordinary skill in the art would understand the terms “body” or “spacer” in
`view of the specification.
`
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`Case IPR2015-01795
`Patent 8,647,386 B2
`2. “move away from one another”
`Claim 1 recites that “linear advancement of the spacer results in
`expansion of the intervertebral implant such that the [first and second
`bodies] move away from one another.” Petitioner asserts that this term reads
`on both (1) one body moving away from another, unmoving body and (2)
`both bodies moving away from a central reference location. Pet. 10–12. As
`support for both interpretations, Petitioner points to the embodiments in
`Figure 9 of the ’386 patent, which include one body moving up (Figs. 9B–
`9E) and two bodies moving away from a central location (Fig. 9F). Id.
`Patent Owner does not offer a construction of this term.
`We agree with Petitioner, based on embodiments shown in Figures
`9B–9F, that a person of ordinary skill in the art would understand that
`“move away from one another” includes both types of movement suggested
`by Petitioner. Accordingly, the broadest reasonable interpretation of the
`term in light of the specification only requires one body to move for the
`bodies to be moving away from one another as claimed.
`
`B. Analysis of Petitioner’s Grounds
`Petitioner asserts that the subject matter of claims 1–4 is unpatentable
`in view of Johnson and the level of ordinary skill in the art. Pet. 13–40. In
`particular, Petitioner reads the first body on the topmost wafer of Johnson
`(which is adjacent a vertebra) and the second body on distal tip 260 of wafer
`inserter 262. Id. at 16–21. Petitioner reads the elongated insertion
`instrument on the wafer inserter of Johnson (id. at 21–25) and the spacer on
`the wafer(s) inserted after the first wafer (id. at 25–30). Petitioner’s Figure
`1, reproduced below, illustrates Petitioner’s position:
`
` 9
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`Case IPR2015-01795
`Patent 8,647,386 B2
`
`
`Figure 1 depicts annotated copies of Figures 4 and 37 of Johnson showing
`how Petitioner reads the claim limitations onto Johnson’s implant.
`Patent Owner argues that “Petitioner makes no attempt to identify the
`missing elements and then explain why they would be obvious to the skilled
`artisan.” Prelim. Resp. 15; see also id. at 18 (making a similar argument).
`Patent Owner also argues that “Johnson is simply a different structural
`arrangement” from claim 1, an argument we understand to be that Johnson
`does not disclose a first body and spacers. Id. at 15–16. Patent Owner next
`argues that the claim provides for only a single spacer, whereas Johnson has
`multiple spacers. Id. Patent Owner argues that, in Johnson, “before the first
`wafer is inserted, there would also be no first body.” Id. at 16–17. Patent
`Owner does not argue the dependent claims at this time. Id. at 19, n.5.
`As to Patent Owner’s argument that the claim precludes multiple
`spacers, we note no such limiting language is found in the claims. The claim
`is in open-ended “comprising” form and claims “a spacer”; the transition
`“comprising” coupled with “a” or “an” is a form understood to permit a
`plurality of elements. Baldwin Graphic Systems, Inc. v. Siebert, Inc., 512
`F.3d 1338, 1342 (Fed. Cir. 2005) (“[t]his court has repeatedly emphasized
`that an indefinite article ‘a’ or ‘an’ in patent parlance carries the meaning of
`
`10
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`Case IPR2015-01795
`Patent 8,647,386 B2
`‘one or more’ in open-ended claims containing the transitional phrase
`‘comprising’”) (internal quotation and citations omitted). Patent Owner
`points to no passage in the claims, specification, or any other evidence in
`support of its position that “a spacer” means one and only one spacer. Cf. id.
`at 1343 (“An exception to the general rule that ‘a’ or ‘an’ means more than
`one only arises where the language of the claims themselves, the
`specification, or the prosecution history necessitate a departure from the
`rule”). Reviewing the record before us, we are not persuaded that the
`structure recited in claim 1 would preclude multiple spacers.
`Patent Owner’s argument that Johnson is a different structural
`arrangement is also not persuasive. The claimed first body is described as
`having external and internal surfaces, with the external surface configured to
`be disposed adjacent a vertebra. Under our construction of the term “first
`body,” the topmost wafer in Johnson satisfies that limitation. The topmost
`wafer 263 has the claimed surfaces and is intended to be disposed adjacent a
`vertebra. See, e.g., Ex. 1004, 13:45–47 (contemplating wafer-to-bone
`bonding), Figs. 27–28 (depicting wafers 198 adjacent a vertebra).2 As
`claimed, a spacer is described as configured such that its linear advancement
`results in expansion of the implant, i.e., movement of the bodies away from
`each other. Wafers 263 also are configured such that linear advancement
`results in a force being applied to the bone, by way of their sloped edges.
`See, e.g., id. at 17:65–66 (“wafers are inserted until the desired height or
`force is attained”). Although Petitioner is reading two limitations on the
`
`
`2 We further note that the embodiment shown in Figure 28 of Johnson has a
`specialized wafer as the first wafer, i.e., the wafer adjacent the vertebra. Ex.
`1004, 14:31–39, Fig. 28.
`
`
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`Case IPR2015-01795
`Patent 8,647,386 B2
`same type of structure (a wafer), we are not persuaded that this is
`impermissible because Petitioner is pointing to two distinct wafers, not the
`same wafer, as meeting both structural elements. The physical
`characteristics of the wafers in Johnson appear to satisfy the limitations of
`both the first body and the spacer of claim 1. Accordingly, we are not
`persuaded, under our preliminary construction and in view of the record
`before us at this time, that Johnson discloses a different structural
`arrangement from what is claimed.
`Patent Owner next argues that, under Petitioner’s reading of the
`claims on Johnson, that “before the first wafer is inserted, there would also
`be no first body.” Prelim. Resp. 16–17. According to Petitioner’s ground,
`the claimed spacer is the second wafer (and/or subsequent wafers) of
`Johnson. See, e.g., Pet. 30 (depicting Petitioner’s Figure 1, also reproduced
`above). Claim 1 requires that a spacer is something that is guided into
`location using a guide after the bodies have been disposed between the
`vertebrae. In this regard, the first inserted wafer in Johnson may not meet
`this limitation, but the second and any subsequent wafers would. At the time
`when the second wafer is to be inserted, the first wafer would have been in
`place between the vertebrae. As such, Patent Owner’s argument is not
`persuasive.
`Patent Owner’s argument that Petitioner has failed to address
`explicitly which limitations, if any, were missing in Johnson is well taken
`but not persuasive that Petitioner has failed to show a reasonable likelihood
`of success. Because Petitioner has addressed where Johnson discloses each
`claim element, we determine that Petitioner has shown a reasonable
`likelihood of success on its obviousness ground. See Cohesive Techs. Inc. v.
`
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`Case IPR2015-01795
`Patent 8,647,386 B2
`Waters Corp., 543 F.3d 1351, 1363–66 (Fed. Cir. 2008) (discussing the
`“anticipation is the epitome of obviousness” maxim and the distinctions
`between anticipation and obviousness).
`Accordingly, based on the record before us, we determine that
`Petitioner has shown a reasonable likelihood that the subject matter of claim
`1 would have been obvious in view of Johnson. Having shown “a
`reasonable likelihood that the petitioner would prevail with respect to at least
`1 of the claims challenged in the petition,” we institute review on claims 1–4
`of the ’386 patent.
`Petitioner offers a second ground of obviousness of Johnson, Pet. 40–
`49, in the event we construed the phrase in claim 1—“move away from one
`another”—in a manner to require both bodies to move. Id. at 40. We do not
`read the claim so narrowly and, thus, do not reach this alternative ground.
`
`III. ORDER
`
`
`
`In view of the foregoing, it is hereby:
`ORDERED that inter partes review is instituted on the ground of
`whether claims 1–4 would have been obvious in view of Johnson and the
`knowledge of a person of ordinary skill in the art;
`FURTHER ORDERED that, pursuant to 35 U.S.C. § 314(c) and 37
`C.F.R. § 42.4, inter partes review of the ʼ386 patent shall commence on the
`entry date of this Order, and notice is hereby given of the institution of a
`trial; and
`FURTHER ORDERED that no ground other than that specifically
`provided above is authorized.
`
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`Case IPR2015-01795
`Patent 8,647,386 B2
`PETITIONER:
`George Moustakas
`David Utykanski
`gdmoustakas@hdp.com
`dutykanski@hdp.com
`
`
`
`PATENT OWNER:
`
`Brett M. Pinkus
`FRIEDMAN, SUDER & COOKE
`pinkus@fsclaw.com
`
`Jonathan T. Suder
`(pro hac vice motion pending)
`FRIEDMAN, SUDER & COOKE
`jts@fsclaw.com
`
`Mark D. Strachan
`(pro hac vice motion pending)
`SAYLES│WERBNER, P.C.
`mstrachan@swtriallaw.com
`
`hermesch@fsclaw.com
`dunn@fsclaw.com
`
`
`
`14
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