Trials@uspto.gov
`Tel: 571-272-7822
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`
`
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`Paper 11
`Entered: February 12, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`STRYKER CORPORATION,
`Petitioner,
`
`v.
`
`ORTHOPHOENIX, LLC,
`Patent Owner.
`_______________
`
`Case IPR2014-01433
`Patent 6,241,734 B1
`_______________
`
`Before JOSIAH C. COCKS, RICHARD E. RICE, and
`SCOTT A. DANIELS, Administrative Patent Judges.
`
`
`RICE, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`
`Paper 11
`Entered: February 12, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`STRYKER CORPORATION,
`Petitioner,
`
`v.
`
`ORTHOPHOENIX, LLC,
`Patent Owner.
`_______________
`
`Case IPR2014-01433
`Patent 6,241,734 B1
`_______________
`
`Before JOSIAH C. COCKS, RICHARD E. RICE, and
`SCOTT A. DANIELS, Administrative Patent Judges.
`
`
`RICE, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`IPR2014-01433
`Patent 6,241,734 B1
`
`
`I. INTRODUCTION
`
`Stryker Corporation (“Petitioner”) filed a Corrected Petition (Paper 4,
`“Pet.”) requesting an inter partes review of claims 1–21 of U.S. Patent
`No. 6,241,734 B1 (Ex. 1001, “the ’734 Patent”). Orthophoenix, LLC
`(“Patent Owner”) filed a Preliminary Response (Paper 10, “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.” 35 U.S.C. § 314(a). We determine that
`Petitioner has shown a reasonable likelihood that it would prevail with
`respect to all of challenged claims 1–21 of the ’734 Patent. Accordingly, we
`institute an inter partes review with respect to the challenged claims.
`
`A. Related Proceedings
`
`Petitioner is named in a federal district court case involving the
`’734 Patent (Orthophoenix, LLC. v. Stryker Corporation, Case No. 13-1628-
`LPS (D. Del.)). Pet. 1; Paper 6, 2. Petitioner also has filed a petition
`seeking an inter partes review with respect to U.S. Patent No. 7,153,307 B2,
`which claims priority from the ‘734 Patent. Pet. 1; Paper 6, 2; see Case
`IPR2014-01434, Paper 1.
`
`B. The ’734 Patent
`
`The ’734 Patent relates to an apparatus for introducing material into
`bone through a subcutaneous cannula. Ex. 1001, 2:3–5. The apparatus
`includes a delivery device to convey the material at “a low delivery
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`IPR22014-01433
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`Patennt 6,241,7334 B1
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`presssure,” whicch is definned as “equuivalent to
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`the pressurre at whichh liquid is
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`exprressed fromm [a] 1 cc ssyringe by the applicaation of mooderate forrce to the
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`syrinnge piston,, which ammounts to a pressure thhat is no ggreater thann about 3600
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`psi.”” Id. at 2:55–10. A caavity formiing instrumment may bbe deploye
`d through
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`form a cavvity. Id. att 3:17–19.
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`
`
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`the ccannula to compress ccancellouss bone and
`Figures
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`25 and 26 of the ’7344 Patent arre reproducced below..
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`Figuure 25 is a pperspectivee view of cconventionnal syringe
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` 104 beingg joined to
`e
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`injecction nozzlle 106, andd Figure 266 is a persppective vieww showingg the nozzl
`a
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`being deployedd through ccannula insstrument 3
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`0 such thaat the nozzlle extends
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`end of the seleccted distannce beyondd the distal cannula innstrument
`and into
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`cavitty 168 of vvertebral boody 148. IId. at 4:41––47, 10:322–33, 16:1––9.
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`As descrribed in thee Specificaation, tampping instrumment 108 iis used to
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`displlace residuual materiaal that remaains in the
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`cannula innstrument aafter the
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`nozzzle has been withdrawwn. Id. at
`16:42–59;
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`Fig. 30.
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`IPR2014-01433
`Patent 6,241,734 B1
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`C. Illustrative Claim
`
`Claims 1, 12, and 15 are independent. Claim 1 is illustrative and is
`reproduced below:
`Apparatus for introducing material
`1.
`into bone through a subcutaneous cannula, the
`apparatus including a subcutaneous cannula, a
`delivery device to convey the material at a delivery
`pressure of no greater than about 360 psi, a nozzle
`instrument capable of advancement
`into
`the
`subcutaneous cannula and comprising a proximal
`fitting to couple the nozzle instrument to the
`delivery device and a nozzle terminus through
`which the material conveyed by the delivery
`device enters bone at the delivery pressure, and a
`tamping instrument capable of advancement into
`the subcutaneous cannula and having a tamping
`terminus which, during the advancement, urges
`material residing in the subcutaneous cannula into
`bone.
`
`Id. at 19:63–20:8.
`
`
`
`D. The Asserted References
`
`Petitioner relies upon the following references (Pet. 3):
`
`US 4,801,263
`Clark
`US 4,576,152
`Müller
`Reiley ’404
`US 5,108,404
`Reiley II
`WO 96/39970 A1
`Baumgartner CA 2,121,001 A1
`Kuslich
`US 5,549,679
`
`
`
`Jan. 31, 1989
`Mar. 18, 1986
`Apr. 28, 1992
`Dec. 19, 1996
`Oct. 22, 1994
`Aug. 27, 1996
`
`Ex. 1004
`Ex. 1005
`Ex. 1006
`Ex. 1007
`Ex. 1008
`Ex. 1009
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`IPR2014-01433
`Patent 6,241,734 B1
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`Deramond Hervé Deramond et al.,
`Percutaneous
`Vertebroplasty, 1:2
`Seminars in
`Musculoskeletal
`Radiology, 285–95
`(June 1997)
`
`E. The Asserted Grounds
`
`June 1997
`
`Ex. 1003
`
`Petitioner challenges claims 1–21 of the ’734 Patent on the following
`grounds (Pet. 3):
`
` Reference(s)
`
`Claims Challenged
`
`15, 16, 19, and 20
`1–21
`1, 3, and 15
`2, 4, 5, 7, 8, 16, 17,
`and 19
`15, 16, and 19
`1–21
`1–21
`1–21
`12
`
` Basis
`§ 102(b)
`§ 103(a)
`§ 102(b)
`
`§ 103(a)
`
`§ 102(b)
`§ 103(a)
`§ 103(a)
`§ 103(a)
`§ 103(a)
`
` 5
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`
`
`Deramond
`Deramond
`Clark
`
`Clark
`
`Müller
`Müller and Reiley ’404
`Müller and Reiley II
`Müller and Baumgartner
`Kuslich
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`
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`IPR2014-01433
`Patent 6,241,734 B1
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`II. ANALYSIS
`
`We turn now to Petitioner’s asserted grounds of unpatentability to
`
`determine whether Petitioner has met the threshold standard of 35 U.S.C.
`§ 314(a) for instituting review.
`
`A. Claim Construction
`
`The Board gives claim terms in an unexpired patent their broadest
`reasonable construction in light of the specification of the patent in which
`they appear. 37 C.F.R. § 42.100(b).
`1. “Subcutaneous cannula”
`Claims 1 and 12 each recite “[a]pparatus for introducing material into
`
`bone through a subcutaneous cannula, the apparatus including a
`subcutaneous cannula . . . .” Claim 15 contains nearly identical language.
`Patent Owner contends that “the cannula is a device that establishes a
`subcutaneous path through soft tissue into bone. The cannula has an interior
`lumen running throughout its entire length.” Prelim. Resp. 14.
`
`Petitioner’s Declarant, Mary E. Jensen, M.D., uses “subcutaneous” to
`“refer to access below the skin.” Ex. 1002, 15 n.1. Petitioner otherwise
`does not propose an express claim construction for “subcutaneous cannula.”
`
`We are persuaded that the Specification largely supports Patent
`Owner’s proposed claim construction. See, e.g., Ex. 1001, Abstract: 1–3,
`6:1–3, 11–13, 42–44. We note, moreover, that the prosecution history also
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`Patent 6,241,734 B1
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`lends support to that construction. To traverse a rejection by the Examiner
`over two prior art references, Coutts1 and Yao2, Patent Owner argued:
`
`Coutts is directed to the fixation of a rod implanted in a
`long bone (i.e., the femur). The distal end of the implanted rod
`is anchored to the distal end of the bone by introducing cement
`through a bore in the rod. Coutts does not teach or suggest
`apparatus for
`introducing material
`into bone
`through a
`subcutaneous cannula (i.e., a cannula that extends through soft
`tissue into bone). Coutts deploys a rod implanted directly into
`exposed bone (i.e., in an open procedure) (see, e.g., column 19,
`lines 58 to 60). In Coutts, there is no subcutaneous cannula.
`
`Sept. 18, 2000 Amendment 3, Ex. 1027, 83. During prosecution, therefore,
`Patent Owner confirmed that a “subcutaneous cannula” must be capable of
`being extended through soft tissue into bone. See Phillips v. AWH Corp.,
`415 F.3d 1303, 1317 (Fed. Cir. 2005) (“[T]he prosecution history can often
`inform the meaning of the claim language by demonstrating how the
`inventor understood the invention and whether the inventor limited the
`invention in the course of prosecution, making the claim scope narrower
`than it would otherwise be.”) (citations omitted).
`
`The broadest reasonable interpretation consistent with the
`Specification of “subcutaneous cannula” is a cannula that has an interior
`lumen running throughout its entire length and that is capable of being
`extended through soft tissue into bone.
`
` 7
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`1 US 5,514,137.
`2 US 5,989,260.
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`Patent 6,241,734 B1
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`2. “Nozzle instrument”
`Claims 1 and 12 recite “a nozzle instrument.” Petitioner does not
`
`propose any express construction for that term. Patent Owner contends that
`“the nozzle instrument is a device capable of advancement through the
`cannula into bone,” that “[t]he nozzle can be coupled to a delivery device to
`convey material through the nozzle terminus into bone,” and that “[i]n use,
`the distal end of the nozzle extends beyond the distal end of the cannula into
`the cavity formed in the cancellous bone.” Prelim. Resp. 16 (citing
`Ex. 1001, 10:52–67, 11:1–5). We are not persuaded, however, that any of
`the exemplary embodiments from the Specification should be read into our
`interpretation of the claim term “nozzle instrument.” See Superguide Corp.
`v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). We
`determine that the broadest reasonable interpretation consistent with the
`Specification of a “nozzle instrument” is a device with an opening through
`which fluid can be expelled. See, e.g., Ex. 1001, 16:14–16, 30–33, Fig. 27.
`At this stage of the proceeding, none of our determinations regarding
`Petitioner’s proposed grounds of unpatentability requires us to construe any
`other claim term expressly.
`
`B. Asserted Anticipation of Claims 15, 16, 19, and 20 by Deramond
`
`Petitioner challenges claims 15, 16, 19, and 20 as anticipated by
`Deramond. Pet. 11–17. To anticipate a patent claim under 35 U.S.C. § 102,
`“a single prior art reference must expressly or inherently disclose each claim
`limitation.” Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1334
`(Fed. Cir. 2008). Under the principles of inherency, if the prior art
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`IPR2014-01433
`Patent 6,241,734 B1
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`necessarily functions in accordance with, or includes, the claimed
`limitations, it anticipates, even though artisans of ordinary skill may not
`have recognized the inherent characteristics or functioning of the prior art.
`MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365
`(Fed.Cir.1999) (citation omitted); In re Cruciferous Sprout Litig.,
`301 F.3d 1343, 1349–50 (Fed.Cir.2002). As discussed below, we are
`persuaded on the current record that Deramond anticipates the challenged
`claims.
`Petitioner and its Declarant, Mary E. Jensen, M.D., assert that
`Deramond discloses all of the recited features of claims 15, 16, 19, and 20.
`Pet. 16–17; Ex. 1002 ¶¶ 65–68. Petitioner relies on Dr. Jensen’s testimony
`to explain the manner in which Deramond discloses an “[a]pparatus for
`introducing material into bone . . . comprising . . . a delivery device to
`convey the material at a delivery pressure of no greater than about 360 psi
`(emphasis added),” as recited in independent claim 15. Id. at 13–14, n. 5,
`n. 6 (citing Ex. 1002 ¶¶ 40, 61; Ex. 1003, 285; Ex. 1011,3 379; Ex. 1012,4
`E1118). Petitioner asserts that Deramond expressly discloses 2- and 3-cc
`luer-lock syringes and that those syringes are capable of conveying bone-
`filling material into a subcutaneous cannula at a delivery pressure of no
`greater than about 360 psi. Id.; Ex. 1002 ¶¶ 39–40, 61, 65 (claim chart).
`
`3 W.A.P. Hayward et al., Pressure generated by syringes: implications for
`hydrodissection and injection of dense connective tissue lesions, 40 Scand. J.
`Rheumatol. 379–82 (2011) (hereinafter “Hayward”).
`4 Jörg Krebs et al., Clinical Measurements of Cement Injection Pressure
`During Vertebroplasty, 30:5 Spine E118–22 (2005) (hereinafter “Krebs”).
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`IPR2014-01433
`Patent 6,241,734 B1
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`Petitioner also asserts that the Specification of the ’734 Patent “expressly
`identifies a ‘conventional syringe’ as the delivery device” and “notes that
`‘the pressure at which liquid is expressed from a 1 cc syringe by the
`application of moderate force . . . amounts to a pressure that is no greater
`than about 360 psi.’” Id. at 13–14 (citing Ex. 1001, 2:7–11, 10:33–39).
`In response, Patent Owner argues that Petitioner and Dr. Jensen have
`not shown that Deramond discloses the “no greater than about 360 psi”
`limitation. Prelim. Resp. 24–28. Patent Owner asserts that Petitioner
`improperly relies on extrinsic evidence, in the form of Dr. Jensen’s
`Declaration, to fill the gap in Deramond’s disclosure. Id. at 25. Patent
`Owner also asserts that Dr. Jensen, in turn, mistakenly relies in her
`Declaration on two references—Hayward and Krebs. Id. at 25–27. Patent
`Owner argues that Hayward is not prior art to the challenged claims, and that
`the data in Krebs is unreliable. Id.
`Upon review of the record at this preliminary stage of the proceeding,
`we are persuaded that the syringes disclosed in Deramond necessarily
`function in accordance with the “no greater than about 360 psi” limitation
`and, therefore, inherently disclose that limitation. See In re Cruciferous
`Sprout Litig., 301 F.3d at 1349 (“It is well settled that a prior art reference
`may anticipate when the claim limitations not expressly found in that
`reference are nonetheless inherent in it.”). We also are persuaded that
`Petitioner and Dr. Jensen do not rely on Hayward as prior art, but rather as
`evidence that the prior art syringes disclosed in Deramond necessarily
`function in accordance with the limitation on delivery pressure.
`
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`IPR2014-01433
`Patent 6,241,734 B1
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`We appreciate, as Patent Owner asserts (Prelim. Resp. 10–11, 26–27),
`that the Patent Office previously reexamined the ’734 Patent and determined
`that: (1) “none of the alleged anticipatory references cited by the third party
`requester, including . . . Deramond, disclose delivery pressure and any
`limitation to delivery pressure;” and (2) “the additionally cited prior art
`references fail to provide sufficient extrinsic evidence to support an
`argument that the characteristic ‘at a delivery pressure of no greater than
`about 360 psi’ is inherent in any of the alleged anticipatory references.”
`Aug. 24, 2006 Notice of Intent to Issue a Reexamination Certificate 2,
`Ex. 2006, 1. The current record, however, is different from the
`reexamination record, and contains persuasive evidence that the limitation
`on delivery pressure is inherent in Deramond.
`Accordingly, we determine that Petitioner has demonstrated a
`reasonable likelihood of prevailing with respect to its challenge that
`Deramond anticipates claims 15, 16, 19, and 20.
`
`C. Asserted Obviousness of Claims 1–21 over Deramond
`
`Petitioner challenges claims 1–21 as obvious over Deramond in view
`of the knowledge of an ordinarily skilled artisan. Pet. 17–27. A claim is
`unpatentable for obviousness under 35 U.S.C. § 103(a) if the differences
`between the subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which the
`subject matter pertains. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). A patent claim composed of several elements, however, is not
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`IPR2014-01433
`Patent 6,241,734 B1
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`proved obvious merely by demonstrating that each of its elements was
`known, independently, in the prior art. Id. at 418. In analyzing the
`obviousness of a combination of prior art elements, it can be important to
`identify a reason that would have prompted one of skill in the art to combine
`the elements in the way the claimed invention does. Id. A precise teaching
`directed to the specific subject matter of a challenged claim is not necessary
`to establish obviousness. Id. Rather, “any need or problem known in the
`field of endeavor at the time of invention and addressed by the patent can
`provide a reason for combining the elements in the manner claimed.” Id.
`at 420.
`Here, Petitioner and its Declarant, Dr. Jensen, assert that Deramond
`renders obvious each of claims 1–21 in view of the knowledge of a person of
`ordinary skill in the art. Pet. 17–27; Ex. 1002 ¶¶ 13 (providing testimony on
`the level of skill in the art), 69–93.
`With respect to claim 1, for example, Petitioner asserts that Deramond
`discloses or suggests the following: a conventional luer-lock syringe (alleged
`“delivery device”) capable of conveying material at a delivery pressure of no
`greater than about 360 psi; 10- and 15-gauge needles, the 15-gauge needle
`(alleged “nozzle instrument”) being capable of advancement into the 10-
`gauge needle (alleged “subcutaneous cannula”); a “proximal fitting” to
`couple the 15-gauge needle to the syringe; a “nozzle terminus” through
`which material conveyed by the syringe enters bone; and a mandrel or stylet
`(alleged “tamping instrument” having a “tamping terminus”) capable of
`advancement into the 10-gauge needle and urging residual material into
`bone. Pet. 18–19; see Ex. 1002 ¶¶ 70–71.
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`Patent 6,241,734 B1
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`With respect to the independent claims, Patent Owner responds that
`“Deramond lacks any indication of a specific limitation on the delivery
`pressure.” Prelim. Resp. 28. As discussed above, however, we are
`persuaded on the record at this preliminary stage of the proceeding that
`Deramond inherently discloses that limitation. Moreover, we are persuaded
`on this record that a person of ordinary skill in the art would have known
`that a conventional syringe is capable of conveying material at a delivery
`pressure of no greater than about 360 psi. See Pet. 13–14; Ex. 1002, 39–40;
`see also Ex. 1001, 11:9–11 (disclosing that conventional syringe 104 ejects
`material in a “low pressure stream”), 16:65–17:2 (describing the “low
`pressure” applied by conventional syringe 104 and tamping device 108 as
`“no greater than 360 psi”).
`Patent Owner also argues that “Deramond lacks a cannula and a
`nozzle” and “there is no indication that [Deramond’s 15-gauge] biopsy
`needle is even suitable or could have been adapted for the purposes
`envisioned by the ’734 patent.” Id. at 30. That argument, however, fails to
`address Dr. Jensen’s testimony that: Deramond “explains that material can
`be delivered through a 15-gauge needle;” and “a person of ordinary skill in
`the art would have understood that material could be delivered (as well as
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`removed) with the coaxial embodiment with the 15‐gauge needle serving as
`
`a nozzle in that context.” Ex. 1002 ¶ 71 (citing Ex. 1003, Fig. 1).
`Patent Owner’s argument that “Deramond also lacks a ‘tamping
`instrument’” (Prelim. Resp. 30) does not address Dr. Jensen’s testimony
`
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`with respect to claim 1 (or similarly with respect to claim 15) that
`Deramond’s mandrel or stylet satisfies that requirement:
`The Deramond Article describes the use of a mandrel (stylet) as
`a tamping instrument, i.e., after cement is delivered through the
`cannula, the mandrel is inserted into the needle urging residual
`material in the cannula into the vertebral body: “Once the
`cement injection is achieved, the needle is slowly pulled back to
`the cortical bone while pushing the mandred [sic, mandrel] into
`the needle.” (p. 287.) The mandrel is a tamping instrument and
`the end of the mandrel is the tamping terminus. An example of
`a mandrel/stylet in the cannula is shown in Figure 4A, p. 288.
`Moreover, a photograph after tamping is shown in Figure 4F, p.
`290 as discussed above.
`
`Ex. 1002 ¶¶ 65 (claim 15 analysis), 71 (incorporating claim 15 analysis).
`
`Patent Owner also does not address Dr. Jensen’s testimony with
`respect to claim 12. Claim 12 contains limitations similar to claims 1
`and 15, but also recites a “nozzle bore,” a “stylet capable of advancement
`into the nozzle bore . . . to close the nozzle bore,” and a “tamping
`instrument” (formed by combining the nozzle instrument with the stylet) to
`urge residual material from the subcutaneous cannula. Ex. 1001, 20:48–55.
`With respect to those limitations, Dr. Jensen testifies:
`
`Deramond discloses a coaxial embodiment where a 15‐gauge
`needle is inserted into a 10‐gauge needle with a stylet shown
`within the 15‐gauge needle. (See Figure 4A.) The article
`separately explains that material can be delivered through a 15‐
`with the 15‐gauge needle serving as a nozzle in that context.
`
`gauge needle (Fig. 1). . . . [I]t would have been obvious to a
`person of ordinary skill in the art that material could be
`delivered (as well as removed) with the coaxial embodiment
`
`Likewise, a person of ordinary skill in the art would have
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`understood that the stylet within the 15‐gauge needle (shown in
`Fig. 4A) could be nested with the 15‐gauge needle to form a
`tamping instrument for the 10‐gauge cannula.
`
`
`Ex. 1002 ¶ 72. Upon review of the record at this preliminary stage of the
`proceeding, we determine that Petitioner has established a reasonable
`likelihood of prevailing on its challenge to claims 1, 12, and 15 as obvious
`over Deramond.
`
`For the reasons discussed below, we also determine that Petitioner has
`established a reasonable likelihood of prevailing on its challenge to
`dependent claims 2–11, 13–14, and 16–19 as obvious over Deramond in
`view of the knowledge of a person of ordinary skill in the art. We are
`persuaded on the current record as follows.
`Deramond discloses a “syringe” as recited in claims 4, 14, and 16.
`See Ex. 1002 ¶ 78.
`Deramond discloses the “generally rigid” limitations of claims 3, 7,
`and 19. See id. ¶¶ 76, 86.
`A nozzle instrument that is “generally flexible” as recited in claim 2
`would have been an obvious design choice/substitution based on evidence
`that “[n]ozzles made of both flexible and rigid materials were . . .
`
`conventional, off‐the‐shelf options available to the ordinary skilled artisan
`
`by August 1998.” Id. ¶ 75; see KSR, 550 U.S. at 416 (“[W]hen a patent
`claims a structure already known in the prior art that is altered by the mere
`substitution of one element for another known in the field, the combination
`must do more than yield a predictable result.”) (citing United States v.
`Adams, 383 U.S. 39, 50–51 (1966)).
`
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`Adding the “markings” required by claims 5 and 17 (as well as claims
`8 and 13) would have been obvious based on evidence that it was known in
`the art to include graduated markings on instruments to gauge visually the
`advancement of one instrument within another instrument such as a cannula.
`See Ex. 1002 ¶¶ 80, 87; see also KSR, 550 U.S. at 417 (“If a person of
`ordinary skill can implement a predictable variation, § 103 likely bars its
`patentability.”).
`The needles and stylets disclosed in Deramond are made of metal and
`thus satisfy the “radiopaque marker” requirement of claims 6, 9, and 18. See
`Ex. 1002 ¶ 82.
`Deramond discloses the “cavity forming instrument” of claims 10 and
`20. See id. ¶ 90.
`A cavity forming instrument that includes “expandable structures” as
`required by claims 11 and 21 would have been obvious based on evidence
`
`that “at the time of the invention (August 1998), balloon‐assisted
`
`vertebroplasty (or kyphoplasty) was known in the art.” Id. ¶ 91; see also
`KSR, 550 U.S. at 417 (stating that a predictable variation likely would have
`been obvious to a person of ordinary skill in the art).
`
`D. Asserted Anticipation or Obviousness Based on Clark
`
`Petitioner challenges claims 1, 3, and 15 as anticipated by Clark and
`claims 2, 4, 5, 7, 8, 16, 17, and 19 as obvious over Clark in view of the
`knowledge of a person of ordinary skill in the art. Pet. 27–34. Clark
`discloses “an osseous implant syringe having a cross-sectional diameter that
`fits easily into graft sites through very small incisions.” Ex. 1004, 2:12–15;
`
`
`16
`
`
`
`
`
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`IPR2014-01433
`Patent 6,241,734 B1
`
`see Pet. 38 (claim chart); Ex. 1002 ¶ 97 (claim chart). Petitioner has not
`persuaded us that Clark’s nozzle member is a “subcutaneous cannula” as
`required by the challenged claims, i.e., a cannula that is capable of being
`extended through soft tissue into bone. See section II.A.1 supra. In
`particular, Petitioner has not explained why the graft sites and small
`incisions disclosed in Clark necessitate extension of Clark’s device through
`soft tissue into bone, as opposed to being inserted directly into exposed bone
`(i.e., in an open procedure). We determine that Petitioner has not
`established a reasonable likelihood of prevailing on its challenge to claims 1,
`3, and 15 as anticipated by Clark and claims 2, 4, 5, 7, 8, 16, 17, and 19 as
`obvious over Clark.
`
`E. Asserted Anticipation of Claims 15, 16, and 19 by Müller
`
`Petitioner challenges claims 15, 16, and 19 as anticipated by Müller.
`Pet. 35–39. Müller relates to “an injector for injecting expandable bone
`cement into a surgically prepared bone cavity.” Ex. 1005, 1:5–7. For
`reasons similar to those discussed above with respect to Clark, Petitioner has
`not persuaded us that Müller discloses a “subcutaneous cannula.” See Pet.
`28–29 (claim chart); Ex. 1002 ¶ 110 (claim chart). We determine that
`Petitioner has not established a reasonable likelihood of prevailing on its
`challenge to claims 15, 16, and 19 as anticipated by Müller.
`
`F. Asserted Obviousness Based in Part on Müller
`
`Petitioner challenges claims 1–21 as obvious over the combinations
`of: Reiley ’404 and Müller; Reiley II and Müller; and Baumgartner and
`Müller. Pet. 39–56. Petitioner and Dr. Jensen assert that Müller discloses a
`
`17
`
`
`
`
`
`
`IPR2014-01433
`Patent 6,241,734 B1
`
`delivery device, i.e., syringe-like cylinder tube 1, capable of conveying
`material at a delivery pressure of no greater than about 360 psi with nozzle
`element 6 attached. E.g., Pet. 36–37, 41, 49, 53; Ex. 1002 ¶ 110 (claim
`chart). Dr. Jensen provides the opinion that, because nozzle tube 7 (of
`nozzle element 6) has a volume of a few cubic centimeters, cylinder tube 1
`necessarily would convey material at a lower delivery pressure than a
`conventional 1 cc syringe. Ex. 1002 ¶ 110 (claim chart). It is not apparent
`to us, however, that Dr. Jensen’s opinion accounts for the size of cylinder
`tube 1, i.e., about 125 cubic centimeters (Ex. 1004, 2:51–54), or Müller’s
`disclosure that shank 14 of ram 10 “functions as a piston within the nozzle
`tube 7 during a ‘high pressure’ injection” (id., 3:25–29). We note Dr.
`Jensen’s alternative opinion that: “In any event, it would be understood that
`an appropriately sized syringe would be selected for the procedures as was
`known in the art.” Ex. 1002 ¶ 120 (claim chart). Dr. Jensen does not
`explain why a person of ordinary skill in the art would have selected such an
`“appropriately sized syringe” instead of using the syringe-like device
`disclosed in Müller.
`For the reasons discussed above, it is not apparent to us that Müller
`discloses or suggests the delivery pressure limitation of “no greater than
`about 360 psi.” In any event, however, we do not institute a trial on any of
`Petitioner’s asserted obviousness grounds that are based in part on Müller in
`view of our determination on the current record that claims 1–21 would have
`been obvious over Deramond. See 37 C.F.R. § 42.208(a) (providing us with
`discretion to authorize review “to proceed on all or some of the grounds of
`unpatentability asserted for each claim.”).
`
`18
`
`
`
`
`
`
`IPR2014-01433
`Patent 6,241,734 B1
`
`G. Asserted Obviousness of Claim 12 over Kuslich
`
`Petitioner challenges claim 12 as obvious over Kuslich in view of the
`knowledge of a person of ordinary skill in the art. Pet. 56–60. Petitioner
`asserts that Kuslich discloses gun-like device 90, which pushes stylet 96
`through a nozzle. Id. at 56; see Ex. 1002 ¶ 160. While noting that Kuslich
`does not specify any particular delivery pressure for device 90, Petitioner
`argues that a pressure less than 360 psi would have been an obvious design
`option, relying on Dr. Jensen’s Declaration. Pet. 57–58 (citing Ex. 1002
`¶¶ 164, 166). In her Declaration, Dr. Jensen testifies that a person of
`ordinary skill in the art would have been “motivated to select a low pressure
`(e.g., under 360 psi), a known preferred option, so that delivery could be
`controlled.” Ex. 1002 ¶ 164 (claim chart).
`Patent Owner argues, inter alia, that no weight should be given to
`Dr. Jensen’s Declaration testimony with respect to Kuslich because it relies
`on “two additional references that are not found in the formal presentation of
`the Petition, Draenert (Ex. 1013)[5] and Huebsch (Ex. 1014).[6]” Prelim.
`Resp. 54–55. Patent Owner further argues:
`By not raising these references in the body of the original
`Petition, the Petitioner has failed to present a reasonable
`likelihood that the claim is obvious over these references.
`Accordingly, the Petition is fatally deficient (37 CFR §42.104)
`and request for Inter Partes review of the present petition based
`on these references should be denied.
`
`
`
`5 US 4,671,263.
`6 US 4,892,550.
`
`
`19
`
`
`
`
`
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`IPR2014-01433
`Patent 6,241,734 B1
`
`Id. at 55. We note, however, that the Petition contains a discussion of the
`asserted relevance of both of those references:
`As discussed above, it was known in the art that a sufficient
`pressure for delivery of bone cement is less than 360 psi. For
`example, as Dr. Jensen explains, one patent discloses a gun-like
`device injecting bone cement at pressures less than 360 psi:
`“[t]he pressure exerted on the bone cement can be precisely
`adjusted and controlled, so that pressures of from 2 bar [29 psi]
`to about 20 bar [290 psi] can build up.” (Jensen Decl. at ¶ 165;
`Ex. 1013 at 5:3-6; see also claim 2.) Another patent discloses a
`device for delivering “suitable rigidly settable material such as
`epoxy or plaster” at “a desired pressure, such as 350 psi or any
`other superatmospheric value chosen by the surgeon as
`desirable. Pressures between 200 and 450 psi are suitable but a
`lower pressure may be selected.” (Ex. 1014 at 7:48-52; see also
`Ex. 1015 at 5:15-23. Thus, a pressure less than 360 psi would
`have been a desirable, “sufficient pressure,” and obvious design
`option. (Jensen Decl. at ¶¶ 164, 166.)
`
`
`Pet. 58 (citations omitted).
`
`Patent Owner further argues that Draenert “specifically criticizes the
`use of syringes with nozzles.” Prelim. Resp. 55 (citing Ex. 1013, 2:20–38).
`That argument, however, does not address Dr. Jensen’s testimony that a
`person of ordinary skill in the art would have been motivated to select a low-
`pressure delivery (less than 360 psi) for Kuslich’s gun-like device 90. See
`Ex. 1002 ¶ 164 (claim chart).
`Upon review of the record at this preliminary stage of the
`proceeding, we determine that Petitioner has established a reasonable
`likelihood of prevailing on its challenge to claim 12 as obvious over
`
`
`20
`
`
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`IPR2014-01433
`Patent 6,241,734 B1
`
`Kuslich in view of the knowledge of a person of ordinary skill in the
`art.
`
`III. CONCLUSION
`
`For the foregoing reasons, we determine that Petitioner has
`established a reasonable likelihood of prevailing on its challenges to:
`claims 15, 16, 19, and 20 under 35 U.S.C. § 102(b) as anticipated by
`Deramond; claims 1–21 under 35 U.S.C. § 103(a) as obvious over
`Deramond in view of the knowledge of a person of ordinary skill in
`the art; and claim 12 under 35 U.S.C. § 103(a) as obvious over
`Kuslich in view of the knowledge of a person of ordinary skill in the
`art. The Board has not made a final determination concerning
`patentability of any of the challenged claims.
`
`IV. ORDER
`
`In consideration of the foregoing, it is hereby:
`ORDERED that an inter partes review of claims 1–21 of the
`’734 Patent is granted;
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), an inter
`partes review of the ’734 Patent is hereby instituted commencing on the
`entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R.
`§ 42.4, notice is hereby given of the institution of a trial; and
`FURTHER ORDERED that the trial is limited to the following
`grounds: claims 15, 16, 1
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