DePuy Orthopaedics, Inc.v.Orthopaedic Hospital

Patent Trial and Appeal Board

Jul 16, 2015

11805867 (P.T.A.B. Jul. 16, 2015)

Trials@uspto.gov Paper No. 17
571.272.7822 Entered: July 16, 2015

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

DEPUY ORTHOPAEDICS, INC.,
Petitioner,

v.

ORTHOPAEDIC HOSPITAL,
Patent Owner.
____________

Case IPR2015-00510
Patent 8,658,710 B2
____________

Before GRACE KARAFFA OBERMANN, JO-ANNE M. KOKOSKI, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

PAULRAJ, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

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INTRODUCTION I.
DePuy Orthopaedics, Inc. (“Petitioner”) filed a Petition requesting an
inter partes review of claims 1–16 of U.S. Patent No. 8,658,710 B2
(Ex. 1001, “the ’710 patent”). Paper 1 (“Pet.”). Orthopaedic Hospital
(“Patent Owner”) filed a Preliminary Response to the Petition. Paper 12
(“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). Upon considering
the Petition and the Preliminary Response, we determine that Petitioner has
not established a reasonable likelihood of prevailing with respect to any of
the challenged claims of the ’710 patent. Accordingly, we deny the Petition,
and do not institute inter partes review.
A. Related Proceedings
The parties identify related district court litigation matters, which have
been consolidated into Orthopaedic Hospital v. DePuy Orthopaedics, Inc.,
Civil Action No. 3:12-cv-00299-CAN. Pet. 2; Paper 5. Additionally, in
IPR2015-00512, Petitioner seeks inter partes review of a related patent,
U.S. Patent No. 8,796,347. Pet. 2; Paper 5.
B. The ’710 Patent (Ex. 1001)
The ’710 patent issued from an application filed on May 24, 2007, and
claims the benefit as the continuation of an application filed on April 27,
2001 and a provisional application filed on April 27, 2000. Ex. 1001, [22],
[63], [60], 1:6–16.
The ’710 patent relates to the use of cross-linked, oxidation-resistant
polyethylenes for making medical implants, such as artificial joint
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components. Id. at 1:21–27. “Ultrahigh molecular weight polyethylene
[UHMWPE] . . . is commonly used to make prosthetic joints such as
artificial hip joints.” Id. at 1:31–33. However, “[i]n recent years, it has
become increasingly apparent that wear of acetabular cups of UHMWPE in
artificial hip joints introduces many microscopic wear particles into the
surrounding tissues.” Id. at 1:41–44. The ’710 patent explains that this
increased wear may be due, in part, to the gamma irradiation used during the
sterilization process: “[g]amma radiation initiates an ongoing process of
chain scission, crosslinking, and oxidation or peroxidation involving the free
radicals formed by the irradiation,” and “spontaneous, post-fabrication
increase in crystallinity and other physical changes . . . occur even in stored
(non-implanted) prostheses after sterilization with gamma radiation.” Id. at
1:55–62, 65–67. “The industrial standard for the gamma sterilization dose is
between 2.5 Mrad to 4 Mrad,” and “[t]ypically, 3 to 3.5 Mrad is used.” Id.
at 1:62–64.
The ’710 patent indicates that a polyethylene implant with high
resistance to oxidation and improved wear resistance may be produced “by
increasing its level of crosslinking above that generated by the dose of
radiation typically used to conventionally sterilize an implant.” Id. at 6:55–
62. The ’710 patent explains that the polyethylene can be formed in a
manner that renders it highly resistant to oxidation, despite the presence of
free radicals, and “there is no need to thermally treat the polyethylene during
or after radiation crosslinking (e.g., by annealing or remelting) in order to
extinguish the residual free radicals, and thus simplifying the manufacturing
process.” Id. at 7:15–21. As such, “it is possible to use direct molded
polyethylene components such as implants, which is not possible if
remelting or annealing of the UHMWPE are required, since this may cause
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excessive distortion of an implant.” Id. at 7:22–25. This provides “the
advantage of allowing for the use of gamma or electron beam to sterilize the
component, rather than gas plasma or ethylene oxide that are currently used
to avoid the free radicals generated by irradiation sterilization.” Id. at 7:28–
31.
C. Illustrative Claim
Petitioner challenges claims 1–16 of the ’710 patent. Claim 1, the
sole independent claim, is illustrative and is reproduced below:
1. A method for producing a wear-resistant and oxidation-
resistant medical implant of a joint prosthesis, said method
comprising the steps of:
(I) providing an oxidation-resistant medical implant of a joint
prosthesis comprising a polyethylene component;
and
(II) irradiating the oxidation-resistant medical implant at a
radiation dose of above 5 Mrad to about 25 Mrad so as to
crosslink the implant thereby improving its wear resistance,
without thermally treating the implant to extinguish free
radicals in the irradiated and crosslinked implant during or
subsequent to irradiating the oxidation-resistant implant;
wherein the oxidation-resistant implant contains an antioxidant
rendering it resistant to oxidation caused by free radicals
generated by the irradiation of step (II); and the irradiated
oxidation-resistant implant possesses the characteristics of: a
degree of swelling of between about 1.7 to about 3.6; a
molecular weight between crosslinks of between about 400 to
about 3,500 g/mol; and a gel content of between about 95% to
about 99%.

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D. Prior Art Relied Upon
Petitioner relies upon the following prior art references:
Reference Patent/Printed
Publication No.
Date Exhibit
Tomita JP 11–239611 A Sept. 7, 1999 1003/10041
Li US 6,794,423 B1 Sept. 21, 2004 1005
Shen WO 98/01085 A1 Jan. 15, 1998 1006
Lidgren WO 00/49079 A1 Aug. 24, 2000 1007

E. The Asserted Grounds of Unpatentability
Petitioner challenges the patentability of the claims of the ’710 patent
on the following grounds (Pet. 11):
References Basis Claims Challenged
Tomita, Li, and Shen § 103 1–16
Lidgren, Li, and Shen § 103 1–16

DISCUSSION II.
A. Claim Construction
In an inter partes review, the Board interprets claim terms in an
unexpired patent according to the broadest reasonable construction 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, 778 F.3d 1271, 1279–81 (Fed.
Cir. 2015). Under that standard, and absent any special definitions, we give
claim terms their ordinary and customary meaning, as would be understood

1 We refer to the certified English translation (Ex. 1004) of the Japanese
language document (Ex. 1003) in our Decision.
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by one of ordinary skill in the art at the time of the invention. See In re
Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special
definitions for claim terms must be set forth with reasonable clarity,
deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480
(Fed. Cir. 1994).
The Board, however, may not “construe claims during IPR so broadly
that its constructions are unreasonable under general claim construction
principles. . . . [T]he protocol of giving claims their broadest reasonable
interpretation . . . does not include giving claims a legally incorrect
interpretation.” Microsoft Corp. v. Proxyconn, Inc., No. 2014-1542,-1543,
slip. op. at 6 (Fed. Cir. June 16, 2015) (citation omitted). Rather, “claims
should always be read in light of the specification and teachings in the
underlying patent,” and “[t]he PTO should also consult the patent’s
prosecution history in proceedings in which the patent has been brought
back to the agency for a second review.” Id. at 7 (citation omitted).
1. “thermally treating”
Independent claim 1 recites a negative limitation requiring that
irradiation of the polyethylene implant at a dose of above 5 Mrad to about 25
Mrad be conducted “without thermally treating the implant . . . during or
subsequent to irradiating the oxidation-resistant implant.” Ex. 1001, 16:47–
53. Although the parties do not propose a construction for the term
“thermally treating,” we determine that its construction is necessary to reach
our Decision.
The Specification states that “there is no need to thermally treat the
polyethylene during or after radiation crosslinking (e.g., by annealing or
remelting) in order to extinguish the residual free radicals.” Ex. 1001, 7:17–
20. The Specification further teaches that the use of direct molded
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polyethylene components “is not possible if remelting or annealing of the
UHMWPE are required, since this may cause excessive distortion of the
implant.” Id. at 7:22–25. Accordingly, both “annealing” and “remelting” of
the implant are obviated by the invention described in the ’710 patent. In
view of this teaching in the Specification, we construe the negative
limitation of “without thermally treating the implant . . .” to preclude either
annealing or remelting, both during and after irradiation.
2. Other Claim Terms
We determine that, for purposes of this Decision, none of the other
terms in the challenged claims requires express construction.
B. Obviousness Based on Tomita, Li, and Shen
Petitioner contends that claims 1–16 would have been obvious under
35 U.S.C. § 103(a) over the combination of Tomita, Li, and Shen. Pet. 16–
37. As support, Petitioner submits the testimony of Dr. Stephen
Spiegelberg. Ex. 1009 ¶¶ 40–82.
1. Overview of Tomita
Tomita describes a “sliding member for artificial joints [that] is
molded from a polyethylene composition that contains polyethylene and
vitamin E group, [which] excels in oxidation resistance and hardly ever
causes oxidative degradation.” Ex. 1004 ¶ 26. Tomita teaches that it is
preferable to use a radiation sterilization method, such as gamma irradiation,
to sterilize the sliding member for medical purposes. Id. ¶¶ 20–21. “There
is no particular limitation on dose of irradiation so long as sterilization can
be done, but it is preferable that the irradiation dose be enough to cause
sufficient crosslinking reactions in the polyethylene.” Id. ¶ 21. Tomita
further teaches that, “since irradiation of 0.1 Mrad or greater can sterilize
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and cause polyethylene to be cross-linked, it is preferable that an irradiation
dose is 0.1 Mrad or greater, and more preferably 0.5 to 5 Mrad.” Id.
Tomita recognizes, however, that “irradiation with gamma rays
produces free radicals within polyethylene,” and resulting “oxidation
reduces wear resistance and fatigue resistance of polyethylene.” Id. ¶ 4.
Tomita teaches that, “as a method to prevent oxidation by eliminating free
radicals in a short period of time, gamma ray irradiation is proposed, but
since oxidation during gamma ray irradiation cannot be suppressed, the
effectiveness of this also is unreliable.” Id. ¶ 5.
2. Overview of Li
Li describes wear resistant polyethylene, specifically UHMWPE, used
for artificial joints that are prepared by irradiation crosslinking. Ex. 1005,
Abstract. Li teaches crosslinking UHMWPE at doses above 2.5–4 Mrad in
order to improve wear resistance. Id. at 4:4–6. Li teaches that, while higher
irradiation at higher doses can adversely affect other properties, such as
fracture toughness, “even at an irradiation dose of 10 Mrads, the decrease in
fracture toughness is substantial.” Id. at 4:17–19. Consequently, Li teaches
“irradiation at a dose higher than 4 Mrads, preferably 5 Mrads, and most
preferably less than 10 Mrads.” Id. at 3:19–20.
Li further teaches:
Heating the irradiated material to the melting point of
UHMWPE is not desirable and can cause deleterious effects
such as causing the modulus of the irradiated material to rise
above 800 MPa. Therefore, the irradiated material should not
be heated above its melting point at any time. According to the
present invention, no heating after irradiation is required.
Id. at 5:60–67.
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3. Overview of Shen
Shen teaches “a method whereby a polymer is irradiated, preferably
with gamma irradiation, then thermally treated, such as by remelting or
annealing.” Ex. 1006, Abstract. “The resulting polymer composition is
wear-resistant and may be fabricated into an in vivo implant.” Id. Shen
teaches that, “[i]n the preferred method, the crosslinked polymer is subject to
thermal treatment such as by remelting (i.e., heated above the melting
temperature of the crosslinked polymer) or annealing (i.e., heated at or
below the melting temperature of the crosslinked polymer) to produce the
preformed polymeric composition.” Id. at 7:52–8:22. Shen further teaches
that “annealing may be used in place of remelting as a means for reducing
the free radicals remaining in the polymer after irradiation crosslinking, in
order to maintain these physical properties within limits required by the
user.” Id. at 14:50–15:1.
Shen also teaches that the following preferred ranges of physical
parameters for acetetabular cups made from UHMWPE have reduced or
non-detectable wear: “a degree of swelling of between 1.7 to about 5.3;
molecular weight between crosslinks of between about 400 to about 8400
g/mol; and a gel content of between about 95% to about 99%.” Id. at 15:41–
47.
4. Analysis
Petitioner shows sufficiently that the prior art references suggest the
irradiation of an oxidation-resistant medical implant made of polyethylene:
wherein the oxidation-resistant implant contains an antioxidant
rendering it resistant to oxidation caused by free radicals
generated by the irradiation of step (II); and the irradiated
oxidation-resistant implant possesses the characteristics of: a
degree of swelling of between about 1.7 to about 3.6; a
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molecular weight between crosslinks of between about 400 to
about 3,500 g/mol; and a gel content of between about 95% to
about 99%.
Ex. 1001, 16:53–61; Pet. 18–20. On this record, the dispositive issue
presented is whether the combination of references suggests a step of
“irradiating the oxidation-resistant medical implant at a radiation dose of
above 5 Mrad to about 25 Mrad . . . without thermally treating the implant to
extinguish free radicals in the irradiated and crosslinked implant during or
subsequent to irradiating the oxidation-resistant implant.” Ex. 1001, 16:47–
53 (emphases added).
Petitioner argues that “Tomita does not disclose or describe any
thermal treatment during or after the irradiation step,” and “[i]n fact teaches
that “gamma ray irradiation followed by annealing . . . also is unreliable.”
Pet. 23 (citing Ex. 1004 ¶ 5). Petitioner argues that Tomita’s silence
regarding any thermal treatment is sufficient to disclose the negative
limitation in the claim. Id. at 24. Petitioner further argues that “Li teaches a
process in which ‘no heating after irradiation is required,’ and that such
heating can cause deleterious effects.” Id. at 23 (citing Ex. 1005, 5:60–67).
As such, Petitioner argues that a person of ordinary skill in the art, “looking
to improve the wear characteristics or increase the amount of crosslinking in
Tomita by increasing the radiation dose would have known from Li that it
was unnecessary to add a thermal treatment step following the radiation.”
Id.
Patent Owner responds that Tomita does not explicitly disclose the
claimed radiation dose, nor does it disclose the absence of any thermal
treatment either during or after irradiation. Prelim. Resp. 23–25. Patent
Owner asserts that Petitioner has not provided any evidence that a person of
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ordinary skill in the art “would read Tomita’s silence with respect to thermal
treatment at a sterilization dose to mean thermal treatment at a higher
irradiation dose, above 5 Mrad, is not required.” Id. at 25. With respect to
Li, Patent Owner contends that the reference only discloses that “no heating
after irradiation is required” and that “the irradiated material should not be
heated above its melting point at any time.” Id. at 22 (citing Ex. 1005, 5:64–
65).
Based on the record before us, we determine that Petitioner has not
demonstrated a reasonable likelihood of prevailing with respect to this
challenge. In particular, we determine that Petitioner has not established that
a person of ordinary skill in the art would have had a sufficient reason, at the
time of the invention, to irradiate the polyethylene implant material taught in
the prior art at a radiation dose above 5 Mrad without also thermally treating
the implant during or after the irradiation step.
As an initial matter, we disagree with Petitioner’s assertion that
Tomita’s silence regarding thermal treatment necessarily teaches or
otherwise suggests the negative limitation recited in the claims. The cases
relied upon Petitioner do not support the proposition that silence in the prior
art always reads on a negative limitation. Cf. Sud-Chemie, Inc. v. Multisorb
Technologies, Inc., 554 F.3d 1001, 1004–05 (Fed. Cir. 2009) (finding claim
requiring “uncoated” film satisfied where prior art “plainly teaches that
containers can be made of films that are heat sealed without the use of
adhesives, and thus without coatings” and where patent owner “has not
offered any evidence that a reference to a microporous or laminate film
would be understood by one of skill in the art as contemplating a film with
an adhesive coating attached”); Upsher-Smith Labs., Inc. v. Pamlab, L.L.C.,
412 F.3d 1319, 1322 (Fed. Cir. 2005) (prior art’s teaching of “‘optional
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inclusion’ of antioxidants teaches vitamin supplement compositions that
both do and do not contain antioxidants,” and therefore read on claim
requiring composition to be “essentially free of antioxidants”) (citations
omitted). Rather, we view the prior art’s silence from the perspective of
whether a person of ordinary skill in the art would have nonetheless
expected the limitation at issue to have been practiced in the prior art. See
Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1361 n.3 (Fed.
Cir. 2008) (“What a prior art reference discloses or teaches is determined
from the perspective of one of ordinary skill in the art.”); see also Unigene
Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1361 (Fed. Cir. 2011) (“A person
of ordinary skill at the time of the invention interprets the prior art using
common sense and appropriate perspective.”).
Tomita does not affirmatively indicate that thermal treatment is
merely an optional step during or after irradiation, and we do not discern any
other suggestion based on the process disclosed by Tomita that a thermal
treatment step can be omitted when irradiating an artificial joint made of
polyethylene. Specifically, we do not find Tomita’s statement that “gamma
ray irradiation followed by annealing is proposed, but since oxidation during
gamma ray irradiation cannot be suppressed, the effectiveness of this also is
unreliable” to indicate that the annealing step should be eliminated
altogether. Ex. 1004 ¶ 5. When read in context, the statement at most
suggests that additional steps, such as the inclusion of an antioxidant, may
be required to provide sufficient wear resistance because annealing by itself
may not be fully effective to prevent or suppress oxidation. Id. ¶ 7 (“[I]n
order to solve the drawbacks of polyethylene sliding members of the prior
art and to improve their wear resistance . . . [the inventors in Tomita]
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discovered that fatigue resistance can be dramatically improved by using
vitamin E group, as an oxidation inhibitor . . . .”).
Even if we accept that Tomita would have been understood as
suggesting that annealing may be not be required in all circumstances, there
is no suggestion of irradiating the polyethylene implant at a dose between
5 Mrad and 25 Mrad without thermally treating the implant during or after
the irradiation, as specifically required by the claims. While the reference
teaches that “[t]here is no particular limitation on dose of irradiation so long
as sterilization can be done,” it further states that the irradiation dose is
“more preferably 0.5 to 5 Mrad,” and does not provide any indication about
whether or not thermal treatment is necessary at higher doses. Id. ¶ 21. We
cannot draw any inference from Tomita’s silence on this point, given the
reference’s more general teaching that thermal treatment was conducted in
the prior art. Ex. 1004 ¶ 5.
The teachings of Li do not make up for this deficiency in Tomita.
Although Li teaches not to heat the irradiated UHMWPE material to or
above its melting point (Ex. 1005, 5:60–66), the claims of the ’710 patent
require irradiation “without thermally treating the implant.” Ex. 1001, 16:50
(Claim 1). As discussed above, we have construed this limitation to
preclude either annealing or remelting during and after irradiation.
Petitioner’s own expert acknowledges that annealing and remelting are two
different “generally accepted methods to thermally treat polyethylene.” Ex.
1009 ¶ 27. Petitioner does not direct us to any evidence indicating that a
skilled artisan would have understood Li’s teaching that it is deleterious to
heat UHMWPE to or above its melting point, to have also suggested the
undesirability of heating to lower (annealing) temperatures.
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Moreover, even if the general statement in Li that “no heating after
irradiation is required” is understood to encompass both annealing and
remelting (Ex. 1005, 5:66–67), the claims also preclude thermal treatment
“during” the irradiation of the implant. We find nothing in Li to dissuade a
person of ordinary skill in the art from thermally treating the implant during,
as opposed to after, the irradiation step. As noted by Patent Owner (Prelim.
Resp. 10), other prior art of record taught advantages associated with heating
during irradiation compared to heating after irradiation. See Ex. 1011, 2:55–
64 (teaching an improved method for creating UHMWPE implants that
requires “preheating the implant, without irradiation, to a predetermined
temperature, followed by irradiation of the preheated implant with a
predetermined quantity of electromagnetic radiation while the implant is
maintained within a predetermined temperature range,” followed by
controlled cooling of the irradiated and heated implant).
Petitioner does not rely upon Shen’s teachings for suggesting the
“without thermally treating” limitation of claim 1. Indeed, as noted above,
Shen specifically teaches that remelting or annealing following irradiation is
preferred, and that there are certain advantages of annealing over remelting.
Ex. 1006, 7:52–8:22, 14:50–15:1. Because this limitation is a requirement
for all the claims of the ’710 patent, we conclude that Petitioner has not
demonstrated a reasonable likelihood of establishing the obviousness of any
of the challenged claims based on the combination of Tomita, Li, and Shen.
C. Obviousness Based on Lidgren, Li, and Shen
Petitioner also contends that claims 1–16 would have been obvious
under 35 U.S.C. § 103(a) over the combination of Lidgren, Li, and Shen.
Pet. 37–56. As support, Petitioner submits the testimony of Dr. Stephen
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Spiegelberg. Ex. 1009 ¶¶ 83–121. The disclosures of Li and Shen are
discussed above.
1. Overview of Lidgren
Lidgren teaches the preparation of UHMWPE doped with an
antioxidant, preferably vitamin E, for use as an implant material. Ex. 1007,
Abstract. Lidgren states that “[t]he implant of the invention has excellent
wear resistance and a decreased degradation before and after implantation in
the body.” Id. at 6:28–30. “The purpose of adding an antioxidant to
UHMWPE is to reduce oxidation of the polymer during sterilization and
post sterilization and thereby decrease the wear of the implant in the body.”
Id. at 6:32–35. In Example 2 of Lidgren, samples of UHMWPE doped with
vitamin E were prepared into 3x3x10 mm rods and “subjected to γ-
irradiation at doses 0-200 kGy [20 Mrad].” Id. at 12:5–10.
Lidgren teaches:
In order to further improve the wear resistance of
UHMWPE or the implants, the antioxidant doped UHMWPE
material may be subjected to γ- or β-radiation at a dose above 2
Mrad, preferably above 9 Mrad, followed by annealing
(remelting), i e subjecting the UHMWPE particles or the
implant to an elevated temperature, preferably above 80 C when
vitamin E is used. This procedure results in an increased
crosslinking of the polymer, thereby enhancing the wear
resistance thereof. This radiation/remelting treatment can be
carried out at any stage in the manufacturing process; from
powder to implant.
Id. at 10:18–28. Lidgren was cited by the Examiner during prosecution, and
formed the basis of anticipation and obviousness rejections that were
subsequently withdrawn. Ex. 1002, 416 (July 17, 2012 Office Action).
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2. Analysis
As with the obviousness challenge based on Tomita discussed above,
the dispositive issue is whether the combination of Lidgren, Li, and Shen
suggests a process of irradiating polyethylene “without thermally treating the
implant . . . during or subsequent to irradiating the oxidation-resistant
implant.” Ex. 1001, 16:50–53 (Claim 1). Petitioner asserts that this
negative limitation is satisfied by the fact that Lidgren’s claims recite a
method wherein antioxidant-doped UHMWPE material is γ-irradiated at a
dose of at least 2 Mrad and, more particularly, at least 9 Mrad without
reciting any thermal treatment step. Pet. 39–40 (citing Ex. 1007, 15:19–23
(Claims 16–17)). Petitioner further relies upon Example 2 of Lidgren, which
specifies that sample rods were subjected to irradiation at doses up to 20
Mrad, without indicating that thermal treatment was also performed. Id. at
39 (citing Ex. 1007, 14:5–10).
Petitioner does not show sufficiently that the cited portions of Lidgren
suggest that a thermal treatment step can or should be omitted. Although “it
is true . . . that a claim is part of the disclosure” of a prior art patent
publication, see In re Benno, 768 F.2d 1340, 1346 (Fed. Cir. 1985)
(quotations and citation omitted), the claims of Lidgren relied upon by
Petitioner are open ended and do not preclude additional steps, such as
annealing or remelting during or after irradiation. We also do not find
Lidgren’s Example 2, which is an experiment designed to measure vitamin E
and free radical concentrations in 3x3x10 mm samples of UHMWPE at
different radiation doses, to suggest that thermal treatment can be omitted
when actually manufacturing a medical implant. Ex. 1007, 14:5–10. And
significantly, Lidgren is not silent as to thermal treatment. To the contrary,
Lidgren specifically teaches that annealing/remelting, i.e., subjecting the
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implant to an elevated temperature following irradiation above 2 Mrad, is
used to further improve the wear resistance of the material. Ex. 1007,
10:18–28.
Petitioner additionally relies upon the same teachings of Li and Shen
as it did with respect to its challenge based on the combination of Tomita,
Li, and Shen. Pet. 40–41. For the reasons discussed above, we find that Li
and Shen do not make up for the deficiency in Lidgren. Accordingly, we
conclude that Petitioner has not demonstrated a reasonable likelihood of
establishing the obviousness of any of the challenged claims based on the
combination of Lidgren, Li, and Shen.

CONCLUSION III.
For the foregoing reasons, we are not persuaded that the Petition
establishes a reasonable likelihood that Petitioner would prevail in showing
that any of claims 1–16 of the ’710 patent are unpatentable under 35 U.S.C.
§ 103(a).2
ORDER IV.
In consideration of the foregoing, it is hereby:
ORDERED that the Petition is denied as to all of the challenged
claims of the ’710 patent.

2 Given our disposition of the Petition, we need not address Patent Owner’s
licensee/judicial estoppel arguments concerning alleged inconsistent
positions taken by Petitioner before the PTO during the prosecution of the
application for the ’710 patent. Prelim. Resp. 28–38.
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For PETITIONER:
Calvin P. Griffith
Michael S. Weinstein
Patrick Norton
JONES DAY
cpgriffith@jonesday.com
msweinstein@jonesday.com
pjnorton@jonesday.com

For PATENT OWNER:
Alexander MacKinnon
Eugene Goryunov
Luke Dauchot
KIRKLAND & ELLIS LLP
alexander.mackinnon@kirkland.com
eugene.goryunov@kirkland.com
luke.dauchot@kirkland.com
OHIPRService@kirkland.com