Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 34
`Entered: March 10, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`ZIMMER BIOMET HOLDINGS, INC.,
`Petitioner,
`
`v.
`
`FOUR MILE BAY, LLC,
`Patent Owner.
`_______________
`
`Case IPR2016-00012
`Patent 8,821,582 B1
`_______________
`
`
`
`
`Before JOSIAH C. COCKS, RICHARD E. RICE, and
`MICHAEL L. WOODS, Administrative Patent Judges.
`
`
`RICE, Administrative Patent Judge.
`
`
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`ZIMMER EXHIBIT 1008
`
`Page 1 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`
`I. INTRODUCTION
`
`A. Background
`
`Zimmer Biomet Holdings, Inc. (“Petitioner”) filed a Petition (Paper 2,
`
`“Pet.”) requesting an inter partes review of claims 1–5, 7–11, 13–15, and
`
`17–20 of U.S. Patent No. 8,821,582 B1 (Ex. 1001, “the ’582 Patent”).
`
`Petitioner supported the Petition with a declaration from Timothy P.
`
`Harrigan (Ex. 1002).
`
`We instituted a trial as to all of the challenged claims, on the
`
`following grounds.
`
` Reference(s)
`
` Basis
`
`Claims Challenged
`
`Zolman1 and Rostoker2
`
`Zolman, Rostoker, and
`Sump3
`Zolman, Rostoker, and
`Averill4
`
`Zolman and Bobyn5
`
`Zolman, Bobyn, and Sump
`
`Zolman, Bobyn, and
`Averill
`
`Paper 8 (“Inst. Dec.”), 21.
`
`§ 103(a)
`
`§ 103(a)
`
`§ 103(a)
`
`§ 103(a)
`
`§ 103(a)
`
`§ 103(a)
`
`1–5, 8–11, 14, 15, and
`17–20
`
`7
`
`20
`
`1–5, 8–11, 13–15, and
`17–20
`
`7
`
`20
`
`
`1 U.S. Patent No. 5,018,285, issued May 28, 1991 (Ex. 1005, “Zolman”).
`2 U.S. Patent No. 3,906,550, issued Sept. 23, 1975 (Ex. 1006, “Rostoker”).
`3 U.S. Patent No. 4,570,271, issued Feb. 18, 1986 (Ex. 1011, “Sump”).
`4 U.S. Patent No. 5,863,295, issued Jan. 26, 1999 (Ex. 1012, “Averill”).
`5 J.D. Bobyn, et al., Characteristics of bone ingrowth and interface
`mechanics of a new porous tantalum biomaterial, 81-B:5 JOURNAL OF BONE
`AND JOINT SURGERY 907 (Sept. 1999) (Ex. 1007, “Bobyn”).
`
`
`
`2
`
`Page 2 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`
`After institution of the trial, Four Mile Bay, LLC (“Patent Owner”)
`
`filed a Patent Owner Response (Paper 17, “PO Resp.”), to which Petitioner
`
`filed a Reply (Paper 24, “Pet. Reply”). Patent Owner supported the Patent
`
`Owner Response with declarations from Michael N. Hemus (Ex. 2041) and
`
`Jay M. Vincelli (Ex. 2042).
`
`We heard oral argument on January 9, 2017. A transcript of the
`
`argument has been entered in the record. Paper 33 (“T.”).
`
`We have jurisdiction under 35 U.S.C. § 6. The evidentiary standard is
`
`a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R.
`
`§ 42.1(d). This Final Written Decision is issued pursuant to 35 U.S.C.
`
`§ 318(a) and 37 C.F.R. § 42.73.
`
`For the reasons explained below, we conclude that Petitioner has
`
`demonstrated by a preponderance of the evidence that claims 1–5, 7–11, 13–
`
`15, and 17–20 are unpatentable.
`
`B. Related Proceedings
`
`The parties identify a related federal district court case involving the
`
`’582 Patent: Four Mile Bay LLC v. Zimmer Holdings, Inc. et al., No. 3:15-
`
`cv-00063 (N.D. Ind.) (PPS)-(CAN). Pet. 2; Paper 5, 2.
`
`C. The ’582 Patent
`
`The ’582 Patent, titled “Hip Implant with Porous Body,” issued on
`
`September 2, 2014, from an application filed August 23, 2012. Ex. 1001, 1.
`
`The ’582 Patent application is a continuation-in-part of an application filed
`
`April 24, 2006, now U.S. Patent No. 8,506,642 B1 (“the ’642 Patent”),
`
`which is a continuation of an application filed May 27, 2003, now
`
`abandoned. Id.
`
`3
`
`Page 3 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`
`Figures 1 and 2 of the ’582 Patent are reproduced below.
`
`
`
`
`
`Figure 1 is a side view of hip implant embodiment 10, showing neck
`
`body 14 and bone fixation body 16; and Figure 2 is a cross-sectional view of
`
`the implant embedded in intramedullary canal 52 of femur 50. Id. at 1:49–
`
`52, 3:41–47, 4:12–14. Bone fixation body 16 has a porous structure, i.e.,
`
`“the material at and under the surface is permeated with interconnected
`
`interstitial pores that communicate with the surface.” Id. at 4:26–28. The
`
`Specification states that “[t]he porous structure of body 16 is adapted for the
`
`ingrowth of cancellous and cortical bone spicules,” and that “the size and
`
`shape of the porous structure emulates the size and shape of the porous
`
`structure of natural bone.” Id. at 4:32–36. The Specification also states that,
`
`preferably, the average pore diameter of body 16 is about 40 µm to about
`
`4
`
`Page 4 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`800 µm, the porosity is from about 45% to 65%, and the interconnections
`
`between pores can have a diameter larger than 50–60 µm. Id. at 4:37–40.
`
`The Specification states that neck body 14 can be machined from a solid
`
`piece of metal to have a size and shape shown in the figures (id. at 3:62–67),
`
`and that bone fixation body 16 is created with a sintering process (id. at
`
`4:49).
`
`The Specification describes two methods of manufacturing the bone
`
`fixation body. In a first exemplary embodiment, body 16 is fabricated using
`
`a mold having two cavities―a first cavity that is sized and shaped for
`
`fabrication of the bone fixation body, and a second cavity that is adjacent
`
`and connected to the first cavity and sized and shaped to receive the already-
`
`fabricated neck body. Id. at 4:55–60. “The neck body is positioned in the
`
`second cavity such that the distal end surface is adjacent and continuous
`
`with the first cavity.” Id. at 4:60–62. Next, the sintering material is placed
`
`in the first cavity, and the mold then is heated to perform the sintering
`
`process. Id. at 4:63–67. “During this process, as the material in the first
`
`cavity heats and sinters, the bone fixation body forms and simultaneously
`
`bonds or fuses to the distal end surface of the neck body.” Id. at 4:67–5:3.
`
`In a second exemplary embodiment, the bone fixation body and the
`
`neck body are each fabricated independently from the other and
`
`subsequently attached together:
`
`One skilled in the art though will appreciate that each of these
`bodies can be fabricated independently and subsequently
`connected together. If the bodies are made separately, then they
`may be attached or fused together using known welding or
`brazing techniques, for example.
`
`Id. at 5:17–23 (emphasis added).
`
`5
`
`Page 5 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`
`Claims 1, 8, and 14 are independent. Claims 2–5 and 7 depend
`
`directly from claim 1, claims 9–11 and 13 depend directly from claim 8, and
`
`claims 15 and 17–20 depend directly from claim 14. Claim 1, reproduced
`
`below, is illustrative of the claimed subject matter:
`
`1. A method, comprising:
`
`machining a neck body formed of solid metal
`to include a neck that receives a femoral ball and
`having a male protrusion that extends outwardly
`from the neck body;
`fabricating, separately from the neck body, a
`bone fixation body with a porous metal structure
`that extends completely throughout the bone
`fixation body with the porous metal structure
`having a size and a shape that emulate a size and a
`shape of a porous structure of natural human bone;
`and
`
`attaching, after the bone fixation body is
`separately fabricated from the neck body, the bone
`fixation body to the neck body to create a hip
`implant such that the male protrusion extends into
`and permanently attaches with the porous metal
`structure of the bone fixation body to create the hip
`implant before the hip implant is implanted,
`wherein the porous metal structure of the bone
`fixation body includes a trapezoidal shape in a
`horizontal cross-sectional view of the hip implant,
`and the male protrusion extends to a distal end of
`the hip implant.
`
`Id. at 15:51–16:4.
`
`D. Prosecution History
`
`Petitioner summarizes the prosecution history relating to the claim
`
`requirement for a bone fixation body with a porous metal structure having a
`
`size and a shape that emulate a size and a shape of a porous structure of
`
`6
`
`Page 6 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`natural human bone. Pet. 9–12. Petitioner notes that the applicant
`
`introduced this requirement by an amendment during prosecution of the
`
`related ’642 Patent application in an effort to distinguish over U.S. Patent
`
`No. 5,522,894, referred to as “Draenert II.” See id. at 10 (citing Ex. 1004,
`
`196–207). The Examiner, however, rejected the applicant’s argument that
`
`the porous structure comprising spherical particles taught in Draenert II does
`
`not have a size and a shape that emulate a size and a shape of a porous
`
`structure of natural human bone. Ex. 1004, 182–183. In the subsequent
`
`appeal, the Examiner maintained his position, arguing that “the porous
`
`structure is being claimed in a functional language recitation rather than a
`
`positive recitation setting forth the specific structural features of the porous
`
`structure.” See id. at 10–11 (citing Ex. 1004, 105). The applicant
`
`subsequently dismissed its appeal and, on continuation of prosecution, relied
`
`on other grounds to distinguish Draenert II. See id. at 11 (citing Ex. 1004,
`
`34–36, 53–64).
`
`The prosecution history of the ’582 Patent application is brief. In a
`
`first office action rejecting the claims (Ex. 1010, 34–44), the Examiner
`
`found that U.S. Patent No. 6,296,667 (“Johnson et. al.”) discloses a bone
`
`fixation body “with the porous metal structure having a size and a shape that
`
`emulate a size and a shape of a porous structure of natural human bone
`
`(abstract) to allow for a three dimensional labyrinth for bone ingrowth and
`
`vascularization (col. 7, ll. 14–16).” Ex. 1010, 37. The applicant
`
`subsequently amended the claims to overcome the Examiner’s rejections,
`
`without challenging the Examiner’s findings. Id. at 24–30.
`
`7
`
`Page 7 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`
`II. ANALYSIS
`
`A. Level of Skill in the Art
`
`Petitioner and Patent Owner agree that “[a] person of ordinary skill in
`
`the art would have had an undergraduate degree in a relevant engineering
`
`field (e.g., Mechanical Engineering, Materials Science Engineering,
`
`Biomedical Engineering) with 3–5 years of experience with hip implants or
`
`similar implants or a graduate degree in a relevant field with 1–3 years of
`
`experience with hip implants or similar implants.” Pet. 13 n.3; PO Resp. 1;
`
`see Ex. 1002 ¶ 10; Ex. 1041 ¶ 26; Ex. 1042 ¶ 22. We agree with, and adopt,
`
`the parties’ common definition of a person having ordinary skill in the art
`
`(“PHOSITA”).
`
`B. Claim Construction
`
`In an inter partes review, the Board gives claim terms in an unexpired
`
`patent their broadest reasonable interpretation in light of the specification of
`
`the patent in which they appear. 37 C.F.R. § 42.100(b); see Cuozzo Speed
`
`Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under that standard, a
`
`claim term generally is given its ordinary and customary meaning, as would
`
`be understood by one of ordinary skill in the art in the context of the entire
`
`disclosure. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`
`2007). While our claim interpretation cannot be divorced from the
`
`specification and the record evidence, see Microsoft Corp. v. Proxyconn,
`
`Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015) (quoting In re NTP, Inc., 654
`
`F.3d 1279, 1288 (Fed. Cir. 2011)), we must be careful not to import
`
`limitations from the specification that are not part of the claim language.
`
`See SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir.
`
`2004). Any special definition for a claim term must be set forth in the
`
`8
`
`Page 8 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`specification with reasonable clarity, deliberateness, and precision. See In re
`
`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`
`1. “porous”
`
`In our Institution Decision, we preliminarily determined that the claim
`
`term “porous” has the following lexicographical meaning: “By ‘porous,’ it
`
`is meant that the material at and under the surface is permeated with
`
`interconnected interstitial pores that communicate with the surface.” Inst.
`
`Dec. 7 (quoting Ex. 1001, 4:26–28). As neither party proposes any change
`
`to our interpretation, and our review of the evidence does not indicate that
`
`any change is necessary, we maintain that interpretation.
`
`2. “a porous metal structure . . . having a size and a shape
` that emulate a size and a shape of a porous structure
`of natural human bone” (claim 1)
`
` and
`
`“a porous metal structure . . . with interconnected pores
` having a geometric structure with a shape and a size
`that emulate a shape and a size of natural human
`bone” (claim 8)
`
`Claim 1 recites “a porous metal structure . . . having a size and a
`
`shape that emulate6 a size and a shape of a porous structure of natural human
`
`bone” (emphasis added). Claim 14 contains essentially the same term.
`
`Claim 8 recites “a porous metal structure . . . with interconnected pores
`
`
`6 In our Institution Decision, we preliminarily determined that the broadest
`reasonable interpretation consistent with the Specification of “emulate” is
`“imitate.” Inst. Dec. 8–9. The parties have adopted our interpretation of
`“emulate.” PO Resp. 1; Pet. Reply 5–8.
`
`9
`
`Page 9 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`having a geometric structure with a shape and a size that emulate a shape
`
`and a size of natural human bone” (emphasis added).
`
`Patent Owner does not propose an explicit claim construction of these
`
`porous-metal-structure claim terms, but nevertheless argues to distinguish
`
`over prior art (Zolman and Rostoker) that the terms require emulating the
`
`size and shape of the interconnected plates and rods that form trabecular
`
`bone. PO Resp. 25–33. Patent Owner asserts that a PHOSITA “would
`
`understand that the term ‘porous metal structure’ recited in the claims is
`
`directed to cancellous bone, which is also known as trabecular bone.”
`
`PO Resp. 26 (citing Ex. 2041 ¶ 68). Patent Owner presents evidence that
`
`“[t]he shape of the cellular structure of trabecular bone is formed of a series
`
`of straight rod-like struts that connect together to form a foam-like cellular
`
`structure” (id. at 28 (citing Ex. 2041 ¶ 72; Ex. 2042 ¶ 59)), and argues that
`
`“[o]ne of ordinary skill in the art would know that the porous structure
`
`taught in Rostoker being formed of sinusoidal kinked wires ‘has no
`
`relationship to the straight rod-like porous structure of natural human bone’”
`
`(id. at 31 (citing Ex. 2041 ¶ 73)).
`
`Petitioner responds that Patent Owner’s implicit construction is
`
`inconsistent with the Specification and overly narrow. Pet. Reply 6.
`
`Petitioner emphasizes that the purpose of emulating the size and shape of the
`
`porous structure of natural bone, as described in the Specification, is to
`
`promote bone ingrowth. Id. (citing Ex. 1001, 4:33–36). Petitioner asserts
`
`that the Specification describes exemplary ranges for average pore diameter,
`
`porosity, and interconnection diameter to achieve that purpose, but does not
`
`“limit the invention to a porous metal structure with those parameters, much
`
`less a porous structure that is the same as human bone.” Id at 7 (citing
`
`10
`
`Page 10 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`Ex. 1001, 4:37–40; Ex. 10197, 100:8–102:6). Petitioner argues that,
`
`“[i]nstead, the specification emphasizes that the purpose of the porous
`
`structure [is] to ‘encourage natural bone to migrate and grow into and
`
`throughout the entire [bone fixation body].’” Id. (citing Ex. 1001, 4:40–43).
`
`Patent Owner has not persuaded us that the porous-metal-structure
`
`claim terms require emulating the size and shape of the interconnected
`
`plates and rods that form trabecular bone. First, Patent Owner’s argument
`
`that a PHOSITA “would understand that the term ‘porous metal structure’
`
`recited in the claims is directed to . . . trabecular bone” (PO Resp. 26) is
`
`conclusory, and the cited testimony of Dr. Hemus is also conclusory. See
`
`PO Resp. 26 (citing Ex. 2041 ¶ 68). Patent Owner’s focus on trabecular
`
`bone, which is only one type of natural human bone, is inconsistent with the
`
`broader recital of “natural human bone” in the claim terms themselves.
`
`Moreover, Patent Owner’s focus on trabecular bone also is inconsistent with
`
`the Specification, which describes the bone fixation body as adapted for the
`
`ingrowth of both cancellous (trabecular) and cortical bone. Ex. 1001, 4:32–
`
`33 (“The porous structure of body 16 is adapted for the ingrowth of
`
`cancellous and cortical bone spicules.”); see id. at 15:31–34 (“The porosity
`
`of the porous structure where the hip implant contacts cortical bone can be
`
`lower than the porosity of the porous structure where the hip implant
`
`contacts cancellous bone.”).
`
`Second, the Specification does not mention the interconnected plates
`
`and rods that form trabecular bone. Rather, the Specification more generally
`
`describes an exemplary embodiment in which the size and shape of the
`
`
`7 Vincelli deposition transcript.
`
`11
`
`Page 11 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`porous structure of body 16 emulates the size and shape of the porous
`
`structure of natural bone:
`
`The porous structure of body 16 is adapted for the
`ingrowth of cancellous and cortical bone spicules. In the
`exemplary embodiment, the size and shape of the porous
`structure emulates the size and shape of the porous structure of
`natural bone.
`
`Id. at 4:32–36. The Specification indicates that the size and shape of the
`
`porous structure of natural bone can be measured by pore diameter, porosity,
`
`and intersection diameter, for which the Specification discloses preferred
`
`ranges. Id. at 4: 4:37–40. The Specification makes clear that “these ranges
`
`could be modified, and the resulting hip implant still within the scope of the
`
`invention” (id. at 4:37–48); and nothing in the Specification indicates that
`
`emulating the size and shape of the porous structure of natural bone requires
`
`emulating the size and shape of the interconnected plates and rods that form
`
`trabecular bone. As such, there is no support in the Specification for Patent
`
`Owner’s argument that the porous-metal-structure claim terms require
`
`emulating that particular structure.
`
`Third, nothing in the prosecution history supports interpreting
`
`the porous-metal-structure claim terms to require emulating the size
`
`and shape of the interconnected plates and rods that form trabecular
`
`bone. During prosecution, the applicant acquiesced in the Examiner’s
`
`interpretation that those claim terms use functional language to define
`
`the porous structure “rather than a positive recitation setting forth the
`
`specific structural features of the porous structure.” Ex. 1004, 105;
`
`see supra Section I.D.
`
`For the reasons given, we determine that the broadest reasonable
`
`interpretation consistent with the Specification of the porous-metal-structure
`
`12
`
`Page 12 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`claim terms is that they require emulating the size and shape of the porous
`
`structure of natural human bone as measured, for example, by pore diameter,
`
`porosity, and intersection diameter, but they do not require emulating the
`
`size and shape of the interconnected plates and rods that form trabecular
`
`bone.
`
`3. Attaching the Bone Fixation Body “After” Separately
`Fabricating it
`
`Claim 1 recites the step of “attaching, after the bone fixation body is
`
`separately fabricated from the neck body, the bone fixation body to the neck
`
`body.” Claims 8 and 14 contain similar recitations.8 Patent Owner argues
`
`that the “attaching” step requires attachment of the bone fixation body to the
`
`neck body “after” fabrication of the bone fixation body. Specifically, Patent
`
`Owner argues:
`
`Because claim[s] 1, 8, and 14 are method claims, one of
`ordinary skill in the art would understand the importance of the
`ordering in which these steps occur. Specifically, claim 1 states
`that the bone fixation body is attached to the neck body “after”
`the bone fixation body is separately fabricated from the neck
`body. This clearly means that the neck body is formed (step 1);
`the bone fixation body is separately fabricated from the neck
`body (step 2); and then these two bodies are attached together to
`create the hip implant after the bone fixation body is separately
`fabricated from the neck body (step 3). Claims 8 and 14 follow
`a similar three step method format.
`
`
`8 Claim 8 recites “connecting, after the bone fixation body is separately
`made from the neck body, the bone fixation body to the neck body.”
`Claim 14 recites “engaging, after the neck body and the bone fixation body
`are separately formed, the bone fixation body to the neck body such that the
`porous metal structure permanently engages to the protrusion [of the neck
`body].”
`
`13
`
`Page 13 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`PO Resp. 36. Patent Owner asserts that the “attaching” step is not directed
`
`to the first exemplary embodiment. Id. at 37; see supra Section I.C. In that
`
`embodiment, as explained by Patent Owner, “the neck body and bone
`
`fixation body are placed in adjacent cavities in a mold, and the bone fixation
`
`body forms and simultaneously bonds to the neck body during a sintering
`
`process.” Id. (citing Ex. 1001, 4:49–5:3) (emphasis added); see also
`
`Ex. 1001, 5:17–18 (“In the aforementioned sintering process, the bone
`
`fixation body simultaneously forms and attaches to the neck body.”). Patent
`
`Owner asserts that the “attaching” step is directed to the second exemplary
`
`embodiment, in which the bone fixation body and the neck body are
`
`fabricated independently from each other, and subsequently connected
`
`together. Id. (citing Ex. 1001, 5:17–23); see supra Section I.C; see also
`
`Ex. 1001, 5:19–21 (“One skilled in the art [] will appreciate that each of
`
`these bodies can be fabricated independently and subsequently connected
`
`together.”).
`
`We agree with Patent Owner that the “attaching” step in claim 1
`
`requires attachment of the bone fixation body to the neck body after
`
`fabrication of the bone fixation body and thus excludes the first exemplary
`
`embodiment. Petitioner’s opposing arguments do not address the
`
`“attaching” step, but instead focus on the “fabricating” step,9 i.e.,
`
`“fabricating, separately from the neck body, a bone fixation body.” Pet.
`
`Reply 8–10 (citing PO Resp. 18–19); see PO Resp. 16.
`
`To the extent Petitioner argues that Patent Owner’s interpretation
`
`improperly excludes the first exemplary embodiment (see Pet. 9–10), we
`
`
`9 We discuss the “fabricating” step below in Section II.B.4.
`
`14
`
`Page 14 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`disagree because Petitioner has not persuaded us that the “attaching” step
`
`can be interpreted reasonably to include that embodiment. See TIP Sys.,
`
`LLC v. Phillips & Brooks/Gladwin, Inc., 529 F.3d 1364, 1373 (Fed. Cir.
`
`2008) (holding that the mere fact the patent disclosed an alternative
`
`embodiment not encompassed by the district court’s claim construction did
`
`not outweigh the language of the claim, especially given the intrinsic
`
`evidence supporting the court’s construction). Petitioner does not dispute
`
`that under Patent Owner’s interpretation the “attaching” step reads on the
`
`second exemplary embodiment. As such, there is intrinsic evidence
`
`supporting Patent Owner’s interpretation.
`
`We determine that the broadest reasonable interpretation consistent
`
`with the Specification of the “attaching” step is that attachment of the bone
`
`fixation body to the neck body must take place subsequent to fabrication of
`
`the bone fixation body. We reach a similar conclusion with respect to the
`
`similar recitations in claims 8 and 14.
`
`4. “fabricating, separately from the neck body,
`a bone fixation body”
`
`In our Institution Decision, we adopted Petitioner’s implicit
`
`construction that the “fabricating” step in claim 1 requires fabrication of the
`
`bone fixation body independent of fabrication of the neck body. Inst.
`
`Dec. 10–11. We rejected, as overly narrow, Patent Owner’s construction
`
`that the “fabricating” step requires the bone fixation body to be physically
`
`separated, i.e., set or kept apart, from the neck body during fabrication of the
`
`bone fixation body. Inst. Dec. 10–11. We reasoned at that stage of the
`
`proceeding that Patent Owner’s construction did not encompass the first
`
`exemplary embodiment, in which neck body 14 is adjacent to the cavity in
`
`15
`
`Page 15 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`the mold in which bone fixation body 16 is fabricated, and thus interpreting
`
`“separately” in claim 1 to mean “set or kept apart” would not be the broadest
`
`reasonable construction consistent with the Specification. We determined
`
`that Petitioner’s construction is broader, and encompasses both the first and
`
`second exemplary embodiments, i.e., in both embodiments, neck body 14 is
`
`fabricated independently from fabrication of fixation body 16. Id. at 11; see
`
`supra Section I.C.
`
`In the Patent Owner Response, Patent Owner argues in support of its
`
`narrower construction that the “fabricating” step, like the “attaching” step
`
`discussed above, is directed specifically to the second exemplary
`
`embodiment “in which the two bodies (bone fixation and neck body) are
`
`fabricated independently from each other and subsequently attached”:
`
`If this “fabricated/made separately” claim language in the
`step for fabricating/making the bone fixation body separately
`from the neck body is not by itself enough to make clear that the
`claims are directed to the second and not the first embodiment at
`column 4, line 49 to column 5, line 23, a further review of the
`subsequent attaching/connecting/engaging step confirms it. In
`the subsequent attaching/connecting/engaging step, the claims
`recite that the bone fixation body is attached/connected/engaged
`to the neck body after the bone fixation body is separately
`fabricated/made/formed, which makes it absolutely clear that the
`claims are directed to the second embodiment in which the two
`bodies
`(bone
`fixation and neck body) are
`fabricated
`independently and subsequently attached, and excludes the first
`embodiment in which the bone fixation body forms and
`simultaneously bonds/fuses to the neck body that is adjacent to
`the mold cavity in which the bone fixation body is formed.
`
`Accordingly, Patent Owner respectfully requests that the
`Board give meaning to the claim terms “after” and “separately
`fabricated/made/formed” in the step 3 attaching/connecting/
`engaging step, and regardless of the interpretation of the term
`“separately” in the step 2 for fabricating/making/forming the
`
`16
`
`Page 16 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`
`bone fixation body, interpret the terms “after” and “separately
`fabricated/made/formed”
`in step 3
`to exclude
`the first
`embodiment at column 4, line 49 to column 5, line 23, require
`that the bone fixation body is not adjacent to the neck body when
`the bone fixation body is formed, and require that the two bodies
`are attached/connected/engaged only after each of the two bodies
`are separately (not adjacently) made.
`
`Id. at 18–19 (italics added).
`
`
`
`We agree with, and adopt, Patent Owner’s argument. As discussed
`
`above, the “attaching” step requires attachment of the bone fixation body to
`
`the neck body subsequent to fabrication of the bone fixation body.
`
`Accordingly, the bone fixation body and the neck body must be fabricated
`
`independently from each other, and then attached together as in the second
`
`exemplary embodiment. This means that the neck body cannot be adjacent
`
`to the cavity of the mold in which the bone fixation body is formed as in the
`
`first exemplary embodiment.
`
`We do not agree with Petitioner that Patent Owner’s narrow
`
`construction improperly imports a limitation from a disclosed embodiment.
`
`See Pet. 9. Rather, Patent Owner’s construction gives a reasonable meaning
`
`to the phrase “separately from the neck body,” is consistent with the second
`
`exemplary embodiment, and considers the context of the surrounding words
`
`of the claim (i.e., the “attaching” step). See ACTV, Inc. v. Walt Disney Co.,
`
`346 F.3d 1082, 1088 (Fed. Cir. 2003) (“While certain terms may be at the
`
`center of the claim construction debate, the context of the surrounding words
`
`of the claim also must be considered.”).
`
`We also note that Patent Owner’s construction is consistent with the
`
`“engaging” step of claim 14, which recites “engaging, after the neck body
`
`and the bone fixation body are separately formed, the bone fixation body to
`
`17
`
`Page 17 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`the neck body” (emphasis added). The most natural reading of the
`
`emphasized language in light of the Specification is that the neck body and
`
`the bone fixation body are formed independently of each other.
`
`We determine that the broadest reasonable construction consistent
`
`with the Specification of the “fabricating” step in claim 1 is that fabrication
`
`of the bone fixation body and the neck body must be performed
`
`independently from each other (and thus this step does not encompass
`
`fabricating the bone fixation body in contact with the neck body as in the
`
`first exemplary embodiment). We reach the same conclusion with respect to
`
`the phrase “separately from the neck body” in claim 8. The “connecting”
`
`step of claim 14 contains the same requirement, i.e., that the neck body and
`
`the bone fixation body must be formed independently from each other.
`
`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). 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. The question of obviousness is resolved on the
`
`basis of underlying factual determinations, including: (1) the scope and
`
`content of the prior art; (2) any differences between the claimed subject
`
`matter and the prior art; (3) the level of skill in the art; and (4) objective
`
`18
`
`Page 18 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`evidence of nonobviousness, i.e., secondary considerations, if in evidence.
`
`See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`
`1. Asserted Obviousness of Claims 1, 8, and 14
`over Zolman and Rostoker
`
`Petitioner challenges claims 1–5, 8–11, 14, 15, and 17–20 as obvious
`
`over Zolman and Rostoker. We first consider independent claims 1, 8,
`
`and 14.
`
`a. Overview of Zolman
`
`Zolman discloses a method of constructing a prosthetic implant that
`
`involves wrapping a porous pad about a prosthesis stem. Ex. 1005, 23–43.
`
`Figures 1 and 2 of Zolman are reproduced below.
`
`Figures 1 and 2 provide perspective and elevation views, respectively,
`
`of femoral component 10. Id. at 2:58–60, 31–35. Porous pad 26 encircles
`
`
`
`19
`
`Page 19 of 48
`
`

`

`IPR2016-00012
`Patent 8,821,582 B1
`
`proximal portion 24 of stem portion 20. Id. at 3:53–54. As described in
`
`Zolman, porous pad 26 preferably is formed first as a substantially flat sheet
`
`and then is wrapped or formed about stem portion 20 (for example, using a
`
`forming fixture with forming jaws) into a final shape corresponding to the
`
`shape of the stem portion. Id. at 4:29–41, 5:22–35. Zolman states that
`
`Rostoker, discussed below, discloses a suitable fiber metal material for
`
`forming porous pad 26. Id. at 4:12–14.
`
`Zolman also discloses that, instead of forming porous pad 26 about
`
`stem portion 20, porous pad 26 alternatively can be formed about a mandrel
`
`having a shape that corresponds to the portion of the implant to which the
`
`pad is to be attached. Id. at 7:1–6. The formed pad is then removed from
`
`the mandrel, placed about femoral c