Trials@uspto.gov
`Tel: 571-272-7822
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`
`
`
`Paper 7
`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 IPR2014-01434
`Patent 7,153,307 B2
`_______________
`
`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 7
`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 IPR2014-01434
`Patent 7,153,307 B2
`_______________
`
`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
`
`
`
`
`
`
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`IPR2014-01434
`Patent 7,153,307 B2
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`
`I. INTRODUCTION
`
`Stryker Corporation (“Petitioner”) filed a Petition (Paper 1, “Pet.”)
`requesting an inter partes review of claims 1–18 of U.S. Patent
`No. 7,153,307 B2 (Ex. 1001, “the ’307 Patent”). Orthophoenix, LLC
`(“Patent Owner”) filed a Preliminary Response (Paper 6, “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 1–18 of the ’307 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
`’307 Patent (Orthophoenix, LLC. v. Stryker Corporation, Case No. 13-1628-
`LPS (D. Del.)). Pet. 1; Paper 5, 2. Petitioner also has filed a petition
`seeking an inter partes review with respect to U.S. Patent No. 6,241,734 B1,
`to which the ‘307 Patent claims priority. Pet. 1; Paper 5, 2; see Case
`IPR2014-01433, Paper 6.
`
`B. The ’307 Patent
`
`The ’307 Patent relates to an instrument for tamping material into
`bone through a subcutaneous path. Ex. 1001, 1:63–64. In one embodiment,
`a cannula is used to establish the subcutaneous path, and material is
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`introduced into bone through the cannula. Id. at 2:6–8. A nozzle instrument
`may be advanced through the cannula and used, in conjunction with a
`delivery device such as a syringe, to convey material through the cannula
`into bone. Id. at 2:11–14, 19–27. Also, a tamping instrument that is capable
`of advancement through the cannula may be used to urge material residing
`in the cannula into bone. Id. at 2:28–33. A cavity forming instrument may
`be deployed through the cannula to compress cancellous bone and to form a
`cavity. Id. at 3:24–26.
`The Specification discloses stylet 182, which is sized to pass through
`the interior bore of nozzle 180. Id. at 18:31–33. “The presence of the
`stylet 182 inside the nozzle 180 closes the interior nozzle bore.” Id. at
`18:38–39. When inserted as a nested unit into cannula instrument 184,
`nozzle 180 and stylet 182 form a tamping instrument that may be advanced
`through the cannula instrument to displace residual material from the
`cannula instrument. Id. at 18:54–57.
`
`C. Illustrative Claim
`
`Claims 1 and 14 are independent. Claim 1 is illustrative and is
`reproduced below:
`A system comprising
`1.
`an access tool sized and configured to
`establish an access path through soft tissue to bone
`having an interior volume occupied, at least in
`part, by cancellous bone,
`a void forming tool sized and configured to
`be introduced through the access path to form a
`void in cancellous bone,
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`a nozzle sized and configured to pass
`through the access path and including an interior
`bore defining a fixed interior volume to receive
`and deliver a measured volume of filling material
`into the void, and
`an auxiliary tool sized and configured to be
`advanced through the interior bore and urge filling
`material from the nozzle.
`
`
`Id. at 20:7–20.
`
`D. The Asserted References
`
`Petitioner relies upon the following references (Pet. 3):
`
`
`Ex. 1006
`July 8, 1975
`Hofsess
`US 3,893,445
`Mar. 18, 1986 Ex. 1005
`US 4,576,152
`Müller
`Apr. 28, 1992
`Ex. 1003
`Reiley ’404 US 5,108,404
`Aug. 29, 1995 Ex. 1008
`Kuslich ’639 US 5,445,639
`Reiley II
`WO 96/39970 A1 Dec. 19, 1996 Ex. 1004
`Grosse
`July 3, 1997
`Ex. 1007
`WO 97/23174
`
`E. The Asserted Grounds
`
`Petitioner challenges claims 1–21 of the ’307 Patent on the following
`grounds (Pet. 3–4):
`
` Reference(s)
`
` Basis
`
`Claims Challenged
`1–7, 10, 13–15, and
`18
`8, 9, 11, 12, and
`14–18
`
`§ 102(b)
`
`§ 103(a)
`
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`Reiley II
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`Reiley II
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` Reference(s)
`
`Reiley ’404 and Müller
`Hofsess
`Hofsess
`Grosse
`Kuslich ’639 and Grosse
`
`
`
` Basis
`§ 103(a)
`§ 102(b)
`§ 103(a)
`§ 102(b)
`§ 103(a)
`
`Claims Challenged
`
`1–18
`1–3, 7, and 10–17
`8 and 9
`1–3, 7, 10, and 13
`1–3 and 5–18
`
`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. “Sized and configured”
`
`Patent Owner contends that the claim term “sized and configured”
`
`means having a specified size, set up for operation in a particular way.
`Prelim. Resp. 16. Petitioner does not propose an express claim construction
`for this claim term. Below, we interpret the claim term “an access tool sized
`and configured to establish an access path through soft tissue to bone
`(emphasis added).” We determine that the included term “sized and
`configured” does not need to be interpreted at this time.
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`2. “An access tool sized and configured to establish
`an access path through soft tissue to bone”
`Neither party proposes an express claim construction for the claim
`
`term “an access tool sized and configured to establish an access path through
`soft tissue to bone.” Patent Owner argues, however, that the “access tool”
`recited in claim 1 must remain in place to establish the required path through
`soft tissue to bone:
`in Grosse, the drilling jig 20 is retracted before the instrument
`40 (which is used to insert the implant) is placed. Ex. 1007,
`pg. 10. In contrast, in the ‘307 patent, the cannula must remain
`in place in order “to establish a path through the soft tissue to
`bone.”
`
`Prelim. Resp. 45 (quoting Ex. 1001, 20:5–13). We largely agree with Patent
`Owner’s implied claim construction. The Specification describes several
`instruments, in addition to cannula instrument 30, that function to establish a
`path through soft tissue to bone. Ex. 1001, 6:6–7:16. Each of the
`instruments, once in place, is used to guide one or more following
`instruments. Id. The Specification explains, for example, that spinal needle
`assembly 20, which comprises stylet 22, “establishes the initial subcutaneous
`path leading to the targeted treatment site;” and guide pin instrument 26,
`which “serves to guide the establishment of the main operative pathway to
`the targeted treatment site,” is deployed through this path, by exchange with
`needle stylet 22.” Id. at 6:14–28.
`
`We determine that that the broadest reasonable interpretation
`consistent with the Specification of the claim term “an access tool sized and
`configured to establish an access path through soft tissue to bone” is an
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`access tool that is capable of defining an access path through soft tissue to
`bone and guiding another instrument along that path.
`
`3. “Nozzle”
`
`Claims 1 and 14 recite “a nozzle.” Petitioner does not propose any
`
`express construction for that term. Patent Owner contends that a “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. 17 (citing Ex. 1001, 2:19–25,
`11:12–14). We are not persuaded, however, that any of the exemplary
`embodiments from the Specification should be read into our interpretation
`“nozzle” as Patent Owner contends. 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” is a device with an opening through which fluid can be expelled.
`See, e.g., Ex. 1001, 16:20–22, 36–39, Fig. 27.
`
`4. “Void forming tool” and “nozzle”
`
`Patent Owner argues that “void forming tool” and “nozzle” are “two
`separate elements,” and the bone cutting assembly of Hofsess “cannot serve
`to meet both elements.” Prelim. Resp. 42 (citing In re Robertson, 169 F.3d
`743 (Fed. Cir. 1999); other citations omitted). Petitioner has not expressed a
`position on the claim interpretation/application issue raised by Patent
`Owner’s argument. While we agree that “void forming tool” and “nozzle”
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`are distinct features of claims 1 and 14, we determine at this stage of the
`proceeding that the broadest reasonable construction consistent with the
`Specification of these limitations does not require two devices that are
`completely separate or independent from one another. As discussed below,
`we are persuaded at this stage of the proceeding that different, but
`overlapping aspects of Hofsess’s bone cutting assembly satisfy the two
`limitations.
`None of our determinations regarding Petitioner’s proposed grounds
`of unpatentability requires us to construe any other claim term expressly.
`
`B. Asserted Anticipation
`
`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 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). With
`these standards in mind, we address each challenge below.
`
`1. Claims 1–7, 10, 13–15, and 18 as Anticipated by Reiley II
`
`Petitioner challenges claims 1–7, 10, 13–15, and 18 as anticipated by
`Reiley II. Pet. 14–20. As discussed below, we are not persuaded that
`Reiley II anticipates the challenged claims.
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`Petitioner argues that “Reiley II discloses a typical balloon‐assisted
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`Claims 14 pertinently requires: (1) a “nozzle” that is sized and
`configured to pass through a “cannula;” and (2) an “auxiliary tool” that is
`sized and configured to be advanced through an interior bore of the nozzle.
`Claim 1 is similar, but requires the nozzle to be sized and configured to pass
`through an “access path” established by an access tool.
`
`vertebroplasty system, i.e., using a cannula (cannula 26) to establish an
`access path through soft tissue to bone; creating a cavity in the bone with a
`balloon (10, 21) that is sized to be advanced through the cannula; and then
`delivering bone cement into the cavity via the access cannula.” Id. at 15
`(citing Ex. 1004, 24:30–25:23,1 Fig. 8). Petitioner further argues that
`“Reiley II also discloses how to manually deliver materials into a vertebral
`cavity via the cannula by using a ‘long pin’ to push materials down ‘a tube’
`that has a diameter that is narrower than the cannula.” Id. (emphasis
`added) (citing Ex. 1004, 40:32–41:3).
`
`Petitioner relies on the following passage of Reiley II:
`To insert materials which do not flow into the balloon-made
`cavity, like hydroxyapatite granules or bone mineral matrix, the
`surgeon can push them down a tube [nozzle] with a long pin
`[auxiliary tool] whose diameter is slightly more narrow than the
`inner diameter of the canula through procedures which the
`minimally-invasive procedure is taking place.
`
`
`
`1 We cite to the page numbers of the printed reference, rather than the page
`numbers of Petitioner’s exhibit.
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`Id. (quoting Ex. 1004, 40:32–41:3 (emphasis by Petitioner; bracketed
`additions by Petitioner)). In asserting that the quoted passage discloses
`using a long pin (asserted “auxiliary tool”) to push materials down a tube
`(asserted “nozzle”) that has a diameter that is narrower than the cannula,
`Petitioner appears to read the phrase “whose diameter is slightly more
`narrow than the inner diameter of the cannula” to modify “a tube” (rather
`than “a long pin”). Id. (citing Ex. 1004, 40:32–41:3).
`Patent Owner disagrees with Petitioner’s analysis of Reiley II and
`argues, persuasively, that “it is not clear from [the passage of Reiley II on
`which Petitioner relies] that the ‘tube’ corresponds to the nozzle element as
`required by the ‘307 [patent]. Rather, the ‘tube’ more likely corresponds to
`the cannula element in the ‘307 patent.” Prelim. Resp. 27. Patent Owner
`reads the phrase “whose diameter is slightly more narrow than the inner
`diameter of the cannula” to modify “a long pin” (not “a tube”) in arguing:
`[T]he diameter of the “pin” is supposed to be slightly
`smaller than that of the “cannula” — and not of that of the
`“tube.” If the “tube” were a separate element in the sense of a
`nozzle, then the “pin” would have to have a slightly smaller
`diameter than the “tube.”
`
`Prelim. Resp. 27.
`We determine that the passage of Reiley II on which Petitioner relies
`for disclosure of an “auxiliary tool” is not clear and, therefore, cannot be
`used to support Petitioner’s anticipation challenge. See In re Turlay,
`304 F.2d 893, 899 (CCPA 1962) (“It is well established that an anticipation
`rejection cannot be predicated on an ambiguous reference.”). In particular,
`the passage does not disclose clearly that the “tube” is distinct from the
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`“cannula” and sized and configured to pass through the cannula, and that the
`“long pin” is sized and configured to be advanced through the tube, as
`required by claims 1 and 14. See Ex. 1004, 40:32–41:3. Accordingly, we
`are not persuaded that Petitioner is reasonably likely to show that Reiley II
`anticipates claims 1 and 14, or their dependent claims 2–7, 10, 13, 15,
`and 18.
`
`2. Claims 1–3, 7, and 10–17 as Anticipated by Hofsess
`
`Petitioner asserts that Hofsess anticipates claims 1–3, 7, and 10–17.
`Pet. 38–44. At this stage of the proceeding, we agree.
`a. Overview of Hofsess
`Figure 1 of Hofsess is reproduced below, with annotations identifying
`certain of the numbered elements.2
`
`
`2 The panel added annotations to Figure 1 to identify numbered elements
`based on their descriptions in the Specification. See Ex. 1006, 4:17–20, 41–
`44, 49–50).
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`Patennt 7,153,3007 B2
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`of a bone
`onal view cross-sectios a partial c of Hofsesss provides
`
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`Figure 1
`
`7, 3:17–188.
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`marrrow biopsyy apparatuss (alignmennt needle 55). Ex. 10006, 2:36–3
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`Cannulaa body 10 oof alignmennt needle 55 is used too penetratee soft tissuee
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`and tto access bbone. Ex. 1006, 3:199–21. Bonee cutting ccannula 35
`includes
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`bonee cutting pooint 38 andd lumen 399 and is cappable of mmoving axiaally in
`
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`lumeen 12 of caannula boddy 5. Id. at 3:43–44, 449–50. Thhe embodimment
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`showwn in Figurre 1 includdes “an optional featuure in condduit 48 whiich passes
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`throuugh shank 40 and hanndle 45 to link with llumen 39 tthereby givving
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`continuous passsage traveersing the eentire bonee cutting coomponent 447.” Id. att
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`3:666–4:2. Hoffsess disclooses that “cconduit 48
`
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`provides aa means off passing a
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`styleet to clear oout bone chhips whichh accumulaate in lumeen 39 durinng use.”
`
`Id. aat 4:4–6.
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`b. Analysis
`Petitioner asserts that Hofsess discloses all of the recited features of
`claims 1–3, 7, and 10–17 and sets forth the evidence from Hofsess to support
`its contentions in detailed claim charts and the Declaration of its Declarant,
`Mary E. Jensen, M.D. Pet. 38–45; Ex. 1002 ¶¶ 118–130. For example,
`Petitioner asserts that bone cutting assembly 47, which includes bone cutting
`cannula 35 and cutting point 38, satisfies the “void forming tool” limitation;
`and that “optional conduit 48 and lumen 39 that traverses the bone cutting
`component” satisfy the “nozzle” limitation. Pet. 40 (claim chart).
`In response, Patent Owner argues that “[t]he bone cutting assembly
`cannot serve to meet both elements, namely, the ‘void forming tool’ and
`‘nozzle’ as these are two separate elements required by the ‘307 patent.”
`Prelim. Resp. 42 (citations omitted). As discussed above, however, the
`broadest reasonable interpretation consistent with the Specification of these
`limitations does not require two devices that are completely separate or
`independent from one another. See section II.A.4 supra. At this stage of the
`proceeding, we are persuaded that the different, but overlapping aspects of
`the bone cutting assembly identified by Petitioner satisfy the “void forming
`tool” and “nozzle” limitations.
`Patent Owner also argues that Hofsess’s stylet does not satisfy the
`“auxiliary tool” limitation because “the stylet is only used after the bone
`cutting cannula 35 is withdrawn from the patient and only used in the
`instance when the biopsy apparatus is optionally configured to be
`nondisposable.” Id. Patent Owner further argues that “[h]ow such a stylet
`equates to an auxiliary tool which is used to urge material, such as flowable
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`cement and fully occupies the interior bore of the nozzle is unclear.” Id.
`at 42–43. At this stage of the proceeding, however, we are persuaded that
`Hoffsess’s stylet is capable of performing the functions recited in the claims.
`Further, on this record, we are persuaded that a person of ordinary skill in
`the art would understand that the stylet “substantially fully” occupies the
`entire lumen as required by claim 14. See Ex. 1002 ¶ 128 (claim chart).
`Accordingly, we determine that Petitioner has demonstrated a
`reasonable likelihood of prevailing with respect to its challenge that Hofsess
`anticipates claims 1–3, 7, and 10–17.
`3. Claims 1–3, 7, 10, and 13 as Anticipated by Grosse
`
`Petitioner asserts that Grosse anticipates claims 1–3, 7, 10, and 13.
`Pet. 46–44. As discussed below, we are not persuaded that Grosse
`anticipates the challenged claims.
` Claim 1 requires “an access tool sized and configured to establish an
`access path through soft tissue to bone” and “a nozzle sized and configured
`to pass through the access path.” As discussed above, the broadest
`reasonable interpretation consistent with the Specification of the claim term
`“an access tool sized and configured to establish an access path through soft
`tissue to bone” is an access tool that is capable of defining an access path
`through soft tissue to bone and guiding another instrument along that path.
`See section II.A.2 supra.
`Petitioner asserts that Grosse’s drilling jig 20 corresponds to the
`“access tool” limitation and that Grosse’s tubular body 41 corresponds to the
`“nozzle” limitation. Pet. 47 (claim chart). We are not persuaded, however,
`
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`that Grosse’s tubular body 41 is “sized and configured to pass through the
`access path,” i.e., the access path established by drilling jig 20, as claim 1
`requires. Rather, we are persuaded, as Patent Owner argues, that drilling
`jig 20 is retracted before tubular body 41 of instrument 40 is deployed and
`that tubular body 41 is not sized and configured to pass through drilling
`jig 20. See Prelim. Resp. 45 (citing Ex. 1007, 10).
`Accordingly, we are not persuaded that Petitioner is reasonably likely
`to show that Grosse anticipates claim 1 or dependent claims 2, 3, 7, 10,
`and 13.
`
`C. Asserted Obviousness
`
`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 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
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`patent can provide a reason for combining the elements in the manner
`claimed.” Id. at 420. With these standards in mind, we address each
`challenge below.
`
`1. Claims 8, 9, 11, 12, and 14–18 as Obvious over Reiley II
`
`Petitioner asserts that claims 8, 9, 11, 12, and 14–18 would have been
`obvious over Reiley II in view of the knowledge of a person of ordinary skill
`in the art. Pet. 20–27. Petitioner does not contend, however, that the
`knowledge of a person of ordinary skill in the art would have remedied the
`deficiency in Reiley II discussed in section II.B.1 supra. Accordingly, we
`are not persuaded that Petitioner is reasonably likely to show that claims 8,
`9, 11, 12, and 14–18 would have been obvious over Reiley II in view of the
`knowledge of a person of ordinary skill in the art.
`
`2. Claims 1–18 as Obvious over Reiley ’404 and Müller
`
`Petitioner asserts that claims 1–18 would have been obvious over
`Reiley ’404 and Müller in view of the knowledge of a person of ordinary
`skill in the art. Pet. 28–38; see Ex. 1002 ¶¶ 28–38.
`Petitioner asserts that Reiley ’404 “teaches performing balloon-
`assisted vertebroplasty by using an access cannula to create an access path
`into the bone, creating a void in the bone with an expandable balloon, and
`thereafter delivering bone cement into the cavity using an injection gun with
`a nozzle.” Id. at 28. Petitioner contends that Reiley ’404 “discloses every
`element of independent claims 1 and 14 of the ‘307 patent except for the
`‘auxiliary tool.’” Pet. 30 (citing Ex. 1002 ¶¶ 92–94). Petitioner relies on the
`knowledge of a person of ordinary skill in the art and Müller to remedy this
`
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`IPR2014-01434
`Patent 7,153,307 B2
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`acknowledged deficiency in Reiley ’404. Pet. 30–32. With respect to the
`knowledge of a person of ordinary skill in the art, Dr. Jensen testifies as
`follows:
`[A]n auxiliary tool sized and configured to be advanced through
`the interior bore and urge filling material from the nozzle, and
`that can be manipulated independently of the nozzle and
`substantially fully occupies the entire interior bore of the
`nozzle, was known to (sic) person of ordinary skill in the art at
`the time of the invention and was a known alternative to using
`an injection gun for cement delivery. Indeed, as evidenced by
`numerous prior art references, it was well known in the art at
`the time of the invention that a physician could deliver filling
`
`material to a vertebral body using hand‐actuation of “an
`
`auxiliary tool” (e.g., manually pushing material with a tool such
`as a pin through a tube rather than using an injection gun).
`
`Ex. 1002 ¶ 94 (citations omitted). As to Müller, Petitioner and Dr. Jensen
`assert that it “teaches using an auxiliary tool to urge filling material such as
`bone cement out of a nozzle.” Pet. 31; Ex. 1002 ¶ 95.
`
`In response, Patent Owner contends that “Muller does not disclose an
`auxiliary tool that is sized and configured to be advanced through the
`interior bore of the nozzle and when fully advanced, substantially fully
`occupying the entire interior bore of the nozzle.” Prelim. Resp. 38. Patent
`Owner argues that “Muller’s ram 10 cannot be advanced through the nozzle
`of Reiley ’404.” Id. This argument misapprehends the law of obviousness
`and is unpersuasive. It is not necessary that references be physically
`combinable in order to render obvious the invention under review. See In re
`Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983). Patent Owner further argues
`that Müller’s ram 10 cannot fully occupy the entire interior bore of
`
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`IPR2014-01434
`Patent 7,153,307 B2
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`Reiley ’404’s nozzle because of its cross-shaped profile and dish-type
`bearing plate at its upper end. Id. This argument is unpersuasive because it
`does not address Dr. Jensen’s testimony with respect to the knowledge of a
`person of ordinary skill in the art, specifically, that an auxiliary tool
`“substantially fully occupying the entire interior bore of the nozzle,” as
`required by claim 14, was a known alternative to using an injection gun for
`cement delivery. See Ex. 1002 ¶ 94 (citations omitted).
`
`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 and 14 as obvious over Reiley ’404
`and Müller in view of the knowledge of a person of ordinary skill in the art.
`
`For the reasons discussed below, we also determine that Petitioner has
`established a reasonable likelihood of prevailing on its challenge to
`dependent claims 2–13 and 15–18 as obvious over Reiley ’404 and Müller in
`view of the knowledge of a person of ordinary skill in the art. We are
`persuaded on the current record as follows.
`
`Reiley ’404 discloses an access tool comprising a “cannula” as recited
`in claim 2. See Ex. 1002 ¶ 105 (claim chart).
`
`Reiley ’404 discloses the “void forming tool” limitations of claims 3–
`6 and 18. See Ex. 1002 ¶¶ 106–108 (claim chart).
`
`Reiley ’404 discloses the “filling material” limitations of claims 13
`and 15. See Ex. 1002 ¶ 110 (claim chart).
`Müller discloses the “elongate tube” requirement of claim 7. See
`
`Ex. 1002 ¶ 112 (claim chart).
`
`
`18
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`IPR2014-01434
`Patent 7,153,307 B2
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`Müller discloses the “receptacle” and “connector” limitations of
`
`claim 8. See Ex. 1002 ¶ 113 (claim chart).
`Adding the “markings” required by claim 9 would have been obvious
`based on evidence that it was known generally 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
`¶¶ 75–78, 114; 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 “elongate body” requirement of claim 10 would have been
`obvious in view of Müller and the knowledge of one of ordinary skill in the
`art. See Ex. 1002 ¶ 115 (claim chart).
`The “general rigid” and “generally flexible” requirements of claims
`11, 12, 16, and 17 would have been obvious in view of Müller and the
`knowledge of one of ordinary skill in the art. See Ex. 1002 ¶ 116 (claim
`chart); 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)).
`
`3. Claims 8 and 9 as Obvious over Hofsess
`
`Petitioner asserts that claims 8 and 9 would have been obvious over
`Hofsess in view of the knowledge of a person of ordinary skill in the art.
`Pet. 44–45. It is not apparent, however, that Patent Owner’s obviousness
`rationale for claim 8 (using a receptacle to deliver filling material to a nozzle
`
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`IPR2014-01434
`Patent 7,153,307 B2
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`and coupling the receptacle to the nozzle with a connector to prevent
`leakage) is consistent with its argument in connection with claim 1 that
`Hofsess’s optional conduit 48 and lumen 39 satisfy the “nozzle” limitation.
`It also is not apparent that one of ordinary skill in the art would have known,
`as Petitioner contends with respect to claim 9, to provide “conventional
`calibration markings” on the bone cutting assembly or nozzle of Hofsess’s
`bone marrow biopsy apparatus to gauge the insertion depth. See Pet. 45
`(citing Ex. 1002 ¶ 134). In any event, however, we do not institute a trial on
`Petitioner’s asserted obviousness ground based on Hofsess in view of our
`determination, discussed supra, that claims 8 and 9 would have been
`obvious over Reiley ’404 and Müller in view of the knowledge of a person
`of ordinary skill in the art. 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.”).
`4. Claims 1–3 and 5–18 as Obvious over
`Kuslich ’639 and Grosse
`Petitioner asserts that claims 1–3 and 5–18 would have been
`obvious over Kuslich ’639 and Grosse in view of the knowledge of a
`person of ordinary skill in the art. Pet. 50–57; see Ex. 1002 ¶¶ 144–
`166. With respect to claims 1 and 14, Petitioner asserts that “Kuslich
`teaches using an ‘access tool,’ which is a ‘cannula’ (locating
`cylinder 104), to establish an access path through soft tissue to a
`vertebral body” (id. at 51 (citing Ex. 1008, 8:25–40, Fig. 16)), and
`introducing a void forming tool (shaft 22) through the cannula to form
`a void in cancellous bone (id. at 52 (citing Ex. 1008, 8:4–8, 40–46,
`
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`Patent 7,153,307 B2
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`9:44–51, Figs. 16–20)). Petitioner does not assert, however, that
`
`Kuslich ’639 teaches a nozzle sized and configured to pass through
`the access path established by cylinder 104, and it is not apparent why
`a person of ordinary skill in the art would have been “motivated to
`select an access cannula (cylinder 104) of Kuslich such that it could
`appropriately receive the nozzle 41 of Grosse,” as Petitioner contends.
`See id. at 53 (citing Ex. 1002 ¶ 154). In any event, however, we do
`not institute a trial on Petitioner’s asserted obviousness ground based
`on Kuslich ’639 and Grosse in view of our determination, discussed
`supra, that claims 1–3 and 5–18 would have been obvious over
`Reiley ’404 and Müller in view of the knowledge of a person of
`ordinary skill in the art. See 37 C.F.R. § 42.208(a).
`
`III. CONCLUSION
`
`For the foregoing reasons, we determine that Petitioner has
`established a reasonable likelihood of prevailing on its challenges to:
`claims 1–3, 7, and 10–17 under 35 U.S.C. § 102(b) as anticipated by
`Hofsess; and claims 1–18 under 35 U.S.C. § 103(a) as obvious over
`Reiley ’404 and Müller 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:
`
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`IPR2014-01434
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`ORDERED that an inter partes review of claims 1–18 of the
`’307 Patent is granted;
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), an inter
`partes review of the ’307 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 1–3, 7, and 10–17 under 35 U.S.C. § 102(b) as anticipated
`by Hofsess; and claims 1–18 u
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