`571.272.7822
`
`
`
`
`
`
` Paper No. 6
`
` Entered: June 7, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ZIMMER BIOMET HOLDINGS, INC., ZIMMER INC., and
`BIOMET INC.,
`Petitioners,
`
`v.
`
`
`
`ADVANCED ORTHOPAEDIC SOLUTIONS, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00311
`Patent 8,092,454 B2
`____________
`
`
`Before LORA M. GREEN, SCOTT A. DANIELS, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`
`INTRODUCTION
`
`Zimmer Biomet Holdings, Inc., Zimmer Inc., and Biomet Inc.
`(collectively “Petitioner”) filed a Petition requesting an inter partes review
`of claims 6–11, 13–15, 19, and 20 of U.S. Patent No. 8,092,454 B2 (Ex.
`1004, “the ’454 patent”). Paper 1 (“Pet.”). Advanced Orthopaedic
`Solutions, Inc. (“Patent Owner”) filed a Preliminary Response to the
`Petition. Paper 5 (“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 considering the Petition and the
`Preliminary Response, we determine that Petitioner has failed to
`demonstrate a reasonable likelihood that it would prevail in showing the
`unpatentability of any of the challenged claims. Accordingly, we decline to
`institute an inter partes review.
`Related Proceedings
`A.
`Petitioner notes that “[t]he ’454 Patent is the subject of the civil action
`Advanced Orthopaedic Solutions, Inc. v. Biomet Inc. et al., Case No. 2:14-
`cv-06354 ODW-(MANx), filed on August 13, 2014 in the U.S. District
`Court for the Central District of California.” Pet. 1.
`We note further that Petitioner filed a second IPR, IPR2016-00236,
`which challenges related U.S. Pat. No. 8,702,707 B2. Trial was instituted in
`IPR2016-00236 on May 31, 2016. IPR2016-00236, Paper 6.
`The ’454 Patent (Ex. 1004)
`B.
`The ’454 patent issued on January 10, 2012, with Gary W. Sohngen as
`the listed inventor. Ex. 1004.
`
`2
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`The ’454 patent is drawn to “a fixation instrument for treating bone
`
`fractures,” and “[m]ore specifically, a nail and bone screw combination used
`to treat a fracture of the femur.” Id. at 1:12–14. “The bone nail extends
`within the shaft portion of a bone such as a femur,” and an “opening in the
`head or proximal end of the nail receives a bone screw that, in the case of a
`femoral neck fracture, extends into the femoral head.” Id. at 1:49–52. “[A]
`locking insert disposed within the nail engages the bone screw and prevents
`rotation thereof.” Id. at 1:53–55.
`
`3
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`
`
`Figure 1 of the ’454 patent is reproduced below:
`
`
`Figure 1 “is a diagrammatic front view of a fixation instrument . . . shown
`implanted within a femur.” Id. at 1:65–67. As can be seen in Figure 1, the
`
`4
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`fixation instrument includes nail member 22 that has distal end 18 and
`proximal end 24. Id. at 2:45–47.
`
`Figure 2 of the ’454 patent is reproduced below:
`
`
`
`Figure 2 “is an enlarged front view of the proximal end of the fixation
`instrument according to the present invention with portions removed for
`clarity and illustration.” Id. at 2:1–3.
`
`As shown in Figure 2, passageway 28 extends through the nail
`longitudinally between the proximal and distal ends. Id. at 2:52–54. The
`
`5
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`passageway may receive a guide wire that may be used to position the nail
`member 22 into the bone 10. Id. at 2:54–57.
`
`The bone screw 32, which is received in nail 22, includes a plurality
`of longitudinally extending grooves 56, which are “of a size and shape that
`are complementary to the locking projections 54 located on the lower
`surface 52 of the insert 36.” Id. at 3:25–29 (emphasis omitted). “Once
`properly aligned, the insert 36 is driven further within or into the chamber 42
`until the lower surface 52 of the insert 36 engages the outer surface 58 of the
`bone screw 32 and the locking projections 54 of the insert 36 extend into the
`grooves 56 of the bone screw 32.” Id. at 3:37–42 (emphasis omitted).
`
`The ’454 patent notes that “[i]t should be understood that the detailed
`description and specific examples, while indicating the preferred
`embodiment of the invention, are intended for purposes of illustration only
`and are not intended to limit the scope of the invention.” Id. at 1:57–61.
`Illustrative Claim
`C.
`Petitioner challenges claims 6–11, 13–15, 19, and 20 of the ’454
`patent. Claims 6, 13, and 19 are independent. Claim 6 is illustrative of the
`challenged claims, and is reproduced below (emphasis added):
`6.
`A fixation instrument for treating a bone fracture
`comprising:
`
` a
`
` nail member, said nail member having a longitudinal axis, a
`distal end and a proximal end, said proximal end having an
`aperture extending therethrough and said nail member having a
`chamber located in said proximal end;
`
`an insert adapted to be positioned within said chamber and
`having a lower surface, said lower surface operative to contact a
`bone screw extending through said aperture;
`
`
`6
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`
`a locking ring received in said chamber and engaging said insert,
`said locking ring operative to secure said insert within said
`chamber;
`
` a
`
` locking projection located on said lower surface of said insert;
`and
`
`said bone screw having a longitudinally axis and having a
`plurality of longitudinal extending grooves, said grooves
`extending substantially parallel to said longitudinal axis of said
`bone screw on an outer surface of said bone screw wherein said
`locking projection is located in one of said grooves when said
`lower surface contacts said bone screw.
`Relative to the claim language shown in italics above, claim 13
`
`requires that the “lower surface [of an insert]. . . engaging said bone screw
`when said bone screw extends through said aperture.” Finally, claim 19
`recites “said lower surface [of an insert] operative to engage a bone screw
`extending through said aperture.”
`D. The Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 6–11, 13–15, 19, and
`20 of the ’454 patent on the following grounds (Pet. 4–5):
`References
`Basis
`Claims Challenged
`Shavit1
`§ 102
`6, 7, 9, 10, and 13
`Shavit and Kilpela2
`§ 103(a)
`8
`Shavit and Kilpela
`§ 103(a)
`14, 15, 19, and 20
`
`
`1 Shavit et al., WO 03/061495 A2, published Jul. 31, 2003 (Ex. 1005)
`(“Shavit”).
`2 Kilpela et al., US Patent No. 6,123,708, issued Sep. 26, 2000 (Ex. 1006)
`(“Kilpela”).
`
`7
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`
`References
`Shavit, Kilpela, and Bramlet3
`Shavit and Bramlet
`
`Petitioner relies also on the Declaration of Richard F. Kyle, M.D.
`Ex. 1001.
`
`Basis
`§ 103(a)
`§ 103(a)
`
`Claims Challenged
`14, 15, 19, and 20
`11
`
`
`
`ANALYSIS
`Claim Construction
`A.
`In an inter partes review, claim terms in an unexpired patent are
`interpreted according to their broadest reasonable constructions in light of
`the Specification of the patent in which they appear. See 37 C.F.R.
`§42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278–79 (Fed.
`Cir. 2015) (“Congress implicitly approved the broadest reasonable
`interpretation standard in enacting the AIA,” and “the standard was properly
`adopted by PTO regulation.”), cert. granted sub nom. Cuozzo Speed Techs.,
`LLC v. Lee, 136 S. Ct. 890 (2016) (mem.) (No. 15-446). Under the broadest
`reasonable construction standard, claim terms are presumed to have 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).
`We determine that, for purposes of this Decision, none of the terms in
`the challenged claims require express construction at this time. See, e.g.
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir.
`
`
`3 Bramlet et al., US Patent No. 6,443,954 B1, issued Sep. 3, 2002 (Ex. 1007)
`(“Bramlet”).
`
`8
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`1999) (noting that only claim terms that are in controversy need to be
`construed, and then only to the extent necessary to resolve the controversy).
`Anticipation by Shavit (Ex. 1005)
`B.
`Petitioner contends that claims 6, 7, 9, 10, and 13 are anticipated by
`Shavit. Pet. 14–27. Patent Owner disagrees. Prelim. Resp. 12–20.
`Overview of Shavit (Ex. 1005)
`i.
`Shavit “relates to the field of surgical nails used to repair bone
`fractures, in particular intramedullary nails used for fractures of the proximal
`femur.” Ex. 1005, 1:3–4. In particular, Shavit discloses “a nail with two
`screws going through it, one screw closer to the proximal end of the nail
`than the other screw, and a locking mechanism, accessible from the proximal
`end, which locks the screw that is further from the proximal end.” Id. at
`2:6–9. The locking mechanism may be an integral part of the nail, such that
`it cannot be removed by mistake. Id. at 2:14–16.
`
`9
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`
`Figures 1A and 1B of Shavit are reproduced below:
`
`
`Figure 1A shows a perspective view, and Figure 1B shows a cross-sectional
`view, of the proximal portion of a nail with holes for inserting two screws,
`with one screw being shown inserted into the nail. Id. at 7:13–15.
`
`As shown in Figures 1A and 1B, nail 12 has holes 14 and 16 for
`inserting two screws. Id. at 7:29–30. Shavit refers to the larger screw as a
`hip peg, and the smaller screw as a hip pin. Id. at 7:33–8:1. The nail has a
`
`10
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`locking mechanism 22 (not labeled), which is accessible from the proximal
`end of the nail and locks in place larger screw 10 without interfering with
`the smaller screw, which is closer to the proximal end. Id. at 7:30–33.
`Shavit teaches that the “[l]ocking mechanism 22 comprises a linear adapter
`24 and a stem 26.” Id. at 9:1–2.
`
`As shown in Figure 1B, hip peg 10 “has a slot 18, and there is a tab
`20, at the end of locking mechanism 22, which fits into slot 18, preventing
`hip peg 10 from coming out of hole 16.” Id. at 8:7–9. Specifically,
`according to Shavit:
`If slot 18 is 20 mm longer, for example, than tab 20, in a direction
`along the axis of the hip peg, then the hip peg is able to move
`back and forth along its axis a distance of 20 mm, even when it
`is locked. Optionally, slot 18 is also wider azimuthally than tab
`20, so that the hip peg is free to rotate by a limited angle when
`tab 20 is inserted into slot 18, in addition to being free to move a
`limited distance along its axis. . . . . Optionally, there is a second
`slot in hip peg 10, shorter than slot 18, so that hip peg 10 would
`not be free to move at all when tab 20 is inserted into the second
`slot. Then hip peg 10 can either be locked completely, or
`partially locked with freedom to move a limited amount.
`Optionally, the second slot is inside slot 18. Alternatively, the
`second slot is separate from slot 18.
`Id. at 8:10–20.
`
`11
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`
`
`Figure 4 of Shavit is reproduced below:
`
`
`
`Figure 4 is drawn to a different embodiment than Figure 1, “showing locking
`mechanisms for two screws.” Id. at 7:21–22.
`As shown in Figure 4, the “locking mechanism for the hip pin
`comprises a lag screw 62 which is inserted into a hole 64 going along the
`axis of locking mechanism 22.” Id. at 13:30–32. Hole 64 extends all the
`way through adapter 24, up to hole 32 in stem 26. Id. at 13:32–33. There
`are threads 66 in part of hole 64 that match the threads of lag screw 62. Id.
`at 13:33–14:1. “When the lag screw is screwed down all the way, it extends
`a short distance into hole 32, and hits the hip pin.” Id. at 14:1–2.
`ii.
`Analysis
`Independent Claims 6 and 13
`a.
`In order for a prior art reference to serve as an anticipatory reference,
`it must disclose every limitation of the claimed invention, either explicitly or
`inherently. In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). We must
`analyze prior art references as a skilled artisan would. See Scripps Clinic &
`
`12
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`Res. Found. v. Genentech, Inc., 927 F.2d 1565, 1576 (Fed. Cir. 1991)
`(stating that to anticipate, “[t]here must be no difference between the
`claimed invention and the reference disclosure, as viewed by a person of
`ordinary skill in the field of the invention”), overruled on other grounds by
`Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282 (Fed. Cir. 2009).
`After careful consideration of all of Petitioner’s evidence and
`contentions as independent challenged claim 6, we determine that Petitioner
`has not sufficiently demonstrated that Shavit teaches “an insert adapted to be
`positioned within said chamber and having a lower surface, said lower
`surface operative to contact a bone screw extending through said aperture”
`(emphasis added). Moreover, similar to claim 6, we determine that
`Petitioner has not sufficiently demonstrated that Shavit teaches a “lower
`surface [of an insert]. . . engaging said bone screw when said bone screw
`extends through said aperture,” as required by independent claim 13. We,
`thus, focus our analysis on those limitations.
`
`Petitioner contends that “Shavit discloses ‘an insert adapted to be
`positioned within said chamber and having a lower surface, said lower
`surface operative to contact a bone screw extending through said aperture.’”
`Pet. 16. Specifically, Petitioner notes that Shavit teaches a locking
`mechanism 22 that comprises a linear adaptor 24, which Petitioner equates
`to the locking ring required by claim 13, and a stem 26, which Petitioner
`equates to the insert required by claim 13. Id. (citing Ex. 1005, 9:1–2).
`
`13
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`
`Petitioner provides the following annotated versions of Figures 1B
`and 4 of Shavit (id. at 17):
`
`
`
`Figure 1B shows a cross-sectional view of the proximal portion of a nail
`with holes for inserting two screws, with one screw being shown inserted
`into the nail, (Ex. 1005, 7:13–15) and Figure 4 shows a locking mechanisms
`for two screws (id. at 7:21–22).
`
`According to Petitioner, as shown in the figures, the “insert is
`positioned within the chamber and includes a lower surface.” Pet. 16.
`Petitioner contends that “Figure 1B also shows that the lower surface of the
`insert is operative to contact the bone screw extending through the aperture.”
`Id. (citing Ex. 1001 ¶¶ 54–55).
`
`Patent Owner responds that Shavit does not disclose that the lower
`surface of the insert is operative to contact a bone screw. Prelim Resp. 15.
`According to Patent Owner:
`Shavit expressly discloses the purpose of the tab 20 fitting in slot
`18 allows the hip peg 10 to move in the aperture 16. Nothing in
`Shavit cites or refers to a lower surface of stem 26 contacting the
`hip peg 10.
`Id. at 16.
`
`14
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`Patent Owner provides the following annotated versions of Figures
`
`3A and 3B of Shavit (id. at 17):
`
`
`
`Figures 3A and 3B of Shavit “show side cross-sectional views of the nail
`seen from two different directions, according to the same embodiment as
`Figs. 1A and 1B, showing the details of the locking mechanism, valve and
`channels.” Ex. 1005, 7:18–20.
`
`Patent Owner contends that as seen in the above annotated figures,
`“no portion of the stem 26, other than the tab 20, extends past the inner
`circumferential or peripheral surface, illustrated by the red line, defining the
`outer boundary of the hole 16.” Prelim. Resp. 17. Patent Owner notes in
`particular that “Shavit discloses the locking mechanism 22 and tab 20
`cooperating with the slot 18 in the hip peg 10 to whereby the hip peg 10
`moves back and forth in the direction of its longitudinal axis.” Id. at 18. If
`the lower surface of stem 26 were to contact hip peg 10, Patent Owner
`contends, it would prevent movement of hip peg 10. Id.
`
`15
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`As to Petitioner’s reliance on the testimony of Dr. Kyle, Patent Owner
`
`argues that “Dr. Kyle provides no specific explanation or identifies evidence
`supporting his opinion.” Id. at 16 (citing 37 C.F.R. § 42.65(a) (“Expert
`testimony that does not disclose the underlying facts or data on which the
`opinion is based is entitled to little or no weight”)).
`
`We agree with Patent Owner that Petitioner has not sufficiently
`established that Shavit discloses an insert having a lower surface that is
`operative to contact a bone screw. Petitioner relies primarily on Figures 1B
`and 4 of Shavit to establish that the insert contacts the bone screw. As noted
`by Patent Owner (Prelim. Resp. 16), “[i]t is well established that patent
`drawings do not define the precise proportions of the elements and may not
`be relied on to show particular sizes if the specification is completely silent
`on the issue.” Hockerson-Halberstadt, Inc. v. Avia Group Int’l Inc., 222
`F.3d 951, 956 (Fed. Cir. 2000). “Ordinarily drawings which accompany an
`application for a patent are merely illustrative of the principles embodied in
`the alleged invention claimed therein and do not define the precise
`proportions of elements relied upon to endow the claims with patentability.”
`In re Olson, 212 F.2d 590, 592 (CCPA 1954).
`
`We have considered the testimony of Dr. Kyle relied upon by
`Petitioner, but it does not convince us otherwise. Dr. Kyle opines, relying
`on annotated Figures 1b and 4 of Shavit:
`Figure 1B shows a cross section of the bone screw, nail member,
`and insert. The bone screw, labeled 10, extends through the
`aperture, labeled 16. In this position, the lower surface contacts
`the bone screw extending through the aperture.
`Ex. 1001 ¶ 55. Dr. Kyle, however, does not point to any disclosure of
`Shavit, or any other evidence, to support his interpretation of the Figures of
`Shavit.
`
`16
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`We acknowledge that Patent Owner also relies on annotated Figures
`
`3A and 3B of Shavit to rebut Petitioner’s contention that Shavit discloses an
`insert having a lower surface that is operative to contact a bone screw. See
`Prelim. Resp. 17–18. The annotation of Figures 3A and 3B by Patent
`Owner, however, is supported by the disclosure of Shavit. Specifically,
`Shavit teaches that hip peg retains a limited ability to move, even when
`locked in place by tab 20. Ex. 1005, 8:10–12. As noted by Patent Owner
`(Prelim. Resp. 18), if the lower surface of the insert were to contact the hip
`peg, the hip peg would lose that ability to move while locked in place by tab
`20. Notably, neither Petitioner nor its expert address how the hip peg retains
`this mobility where Shavitz’s insert allegedly contacts the hip peg. Nor does
`Petitioner provide any evidence that the ordinary artisan would read such
`contact between the hip peg and the lower surface of the insert to continue to
`allow for such movement. Petitioner, therefore, has failed to establish a
`reasonable likelihood that independent claim 6 is anticipated by Shavit
`
`As to independent claim 13, Petitioner contends that, as discussed
`with respect to claim 6, “Shavit discloses an insert adapted to be positioned
`within said chamber, with a lower surface that engages the bone screw when
`the bone screw extends through the aperture.” Pet. 25. We determine,
`therefore, for the reasons discussed above with respect to independent claim
`6, that Petitioner has failed to establish a reasonable likelihood that
`independent claim 13 is anticipated by Shavit.
`Remaining Claims
`b.
`Claims 7, 9, and 10 each depend, either directly, or indirectly from
`claim 6. In addressing these claims, Petitioner does not point us to any
`additional teaching of Shavit that addresses the deficiency discussed above.
`
`17
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`Thus, for the reasons set forth above, Petitioner has also failed to sufficiently
`demonstrate that dependent claims 7, 9, and 10 are anticipated by Shavit.
`iii. Conclusion
`For the reasons set forth above, we determine that Petitioner has not
`established a reasonable likelihood that claims 6, 7, 9, 10, and 13 are
`anticipated by Shavit.
`
`Remaining Grounds
`C.
`Petitioner contends that the remaining independent claim, claim 19, is
`rendered obvious by the combination of Shavit and Kilpela, or by the
`combination of Shavit, Kilpela, and Bramlet. Pet. 34–39, 45–46.
`In challenging claim 19 over the combination of Shavit and Kilpela,
`as to the limitation that “said lower surface [of an insert] operative to engage
`a bone screw extending through said aperture,” Petitioner states that for the
`reasons discussed as to claim 8, Shavit in view of Kilpela renders that
`limitation obvious. Pet. 37 (emphasis added). Petitioner relies on that same
`analysis as to the challenge of claim 19 over the combination of Shavit,
`Kilpela, and Bramlet. Id. at 46.
`In its discussion of claim 8 as being obvious over the combination of
`Shavit and Kilpela, Petitioner relies on Kilpela for a reason to have a
`longitudinal passageway through the insert. Id. at 28. As to the remaining
`limitations of claim 8, which depends from claim 6, Petitioner relies on its
`discussion of claim 6 as being anticipated by Shavit. Id. Petitioner,
`therefore, does not rely on either Kilpela or Bramlet to make up the
`deficiency of Shavit as discussed above as to the anticipation challenge of
`independent claim 6. Thus, for the reasons discussed above in Section
`II.B.ii.a, we determine that Petitioner has not sufficiently established that
`
`18
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`claim 19 is rendered by the combination of Shavit and Kilpela, or the
`combination of Shavit, Kilpela, and Bramlet.
`Similarly, Petitioner relies on its discussion of independent claims 6,
`13, and 19 in contending that claim 8 is rendered obvious by the
`combination of Shavit and Kilpela (Pet. 28), that claims 14, 15, and 20 are
`rendered obvious by the combination of Shavit and Kilpela (Pet. 31–33, 39–
`40) or by the combination of Shavit, Kilpela, and Bramlet (Pet. 40–45, 47),
`and that claim 11 is rendered obvious by the combination of Shavit and
`Bramlet (Pet. 47–48). As Petitioner again does not rely on either Kilpela or
`Bramlet to remedy the above discussed deficiency of Shavit, we determine
`also that Petitioner has not sufficiently established that claims 8, 11, 14, 15,
`and 20 are rendered by the Shavit in combination with Kilpela and/or
`Bramlet.
`
` CONCLUSION
`For the foregoing reasons, we are not persuaded that the Petition
`establishes a reasonable likelihood that Petitioner would prevail in any of its
`challenges of claims 6–11, 13–15, 19, and 20.
` ORDER
`In consideration of the foregoing, it is hereby ordered that the Petition
`is denied.
`
`
`
`19
`
`
`
`
`
`IPR2016-00311
`Patent 8,092,454 B2
`
`PETITIONER:
`Eric Hayes
`Xun (Michael) Liu
`eric.hayes@kirkland.com
`michael.liu@kirkland.com
`
`PATENT OWNER:
`Joseph Burgess
`jburgess@burgessiplaw.com
`
`
`20