Ex Parte 6818020 et al

Patent Trial and Appeal Board

Apr 30, 2014

95000428 (P.T.A.B. Apr. 30, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
95/000,428 01/22/2009 6818020 OSTEONICS
3.5-095DIDCCCCC
5713
530 7590 04/30/2014
LERNER, DAVID, LITTENBERG,
KRUMHOLZ & MENTLIK
600 SOUTH AVENUE WEST
WESTFIELD, NJ 07090
EXAMINER
JASTRZAB, KRISANNE MARIE
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
04/30/2014 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
1

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE PATENT TRIAL AND APPEAL BOARD
____________

SMITH & NEPHEW, INC. AND ZIMMER, INC.
Requester

v.

HOWMEDICA OSTEONICS CORP.
Patent Owner and Appellant
____________

Appeal 2013-007710
Reexamination Control 95/000,428
Patent 6,818,020 B2
Technology Center 3900
____________

Before MARK NAGUMO, RICHARD M. LEBOVITZ, and
RAE LYNN P. GUEST, Administrative Patent Judges.

GUEST, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal by the Patent Owner from the Patent
Examiner’s decision to reject pending claims in an inter partes
reexamination of U.S. Patent 6,818,020 B2 (hereinafter, “the ’020 patent”),
which issued November 16, 2004 to Deh-Chuan Sun et al. The Board’s
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2

jurisdiction for this appeal is under 35 U.S.C. §§ 6(b), 134, and 315. We
AFFIRM-IN-PART.

I. BACKGROUND
A request for inter partes reexamination under 35 U.S.C. §§ 311-318
and 37 C.F.R. §§ 1.902-1.997 for the ’020 patent was filed January 22, 2009
by joint Third-Party Requesters, Smith and Nephew, Inc. and Zimmer, Inc.
(hereinafter jointly referred to as “Requester”). Request for Inter Partes
Reexamination; Requester’s Respondent Brief 1, dated October 15, 2012
(hereinafter “Req. Res. Br.”). The Patent Owner is Howmedica Osteonics
Corp. Patent Owner Appeal Br. 1, dated May 18, 2012 (hereinafter “App.
Br.”). Claims 1-12 are pending and stand rejected. An oral hearing was
held October 30, 2013. A transcript of the hearing was entered into the
record.
The ’020 patent is the subject of a pending litigation in the District of
New Jersey styled Howmedica Osteonics Corp. v. Zimmer, Inc., et al., No.
2:05-cv-00897-WHW. This litigation is stayed pending the outcome of this
reexamination proceeding. App. Br. 1; Req. Res. Br. 1.
The ’020 patent issued from U.S. Application No. 10/461,636 on
November 16, 2004. The ’020 patent claims priority through a chain of
continuation and divisional applications to U.S. Application No. 08/070,074
filed June 1, 1993, now U.S. Patent 5,414,049. The ’020 patent thus expired
June 1, 2013, 20 years from the earliest filed application date.
The’020 patent is directed to an ultra-high molecular weight
polyethylene (UHMWPE) medical implant with good oxidation resistance
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upon irradiation. ’020 patent, col. 1, ll. 20-24; col. 3, ll. 35-37. Upon
application of sterilizing radiation to the implant, free radicals are formed
(arising from C-C chain scission or C-H scission (id. at col. 2, l. 5)), which
cause UHMWPE to become activated for chemical reactions and physical
changes, making the resulting implant susceptible to oxidation. Id., col. 3, ll.
45-51. Although some polymer free radicals may recombine soon after
irradiation, others may persist, resulting in degradation of polymer properties
over time. Id. at col. 3, ll. 1-11. The’020 patent describes a process in
which a UHMWPE is irradiated under inert conditions and subsequently
annealed to cross-link all the free radicals without employing “stabilizers,
oxidants, or any other chemical compounds which may have potential
adverse effects in biomedical or orthopedic applications.” Id. col. 3,
ll. 54-47. As a result, the UHMWPE is said to become cross-linked and to
have an oxidation resistance “similar to that of the unirradiated virgin
polymer.” Id. at col. 3, l. 65-col. 4, l. 7.
The claims of the ’020 patent are directed to a medical implant
comprising an irradiated UHMWPE, having a weight average molecular
weight greater than 400,000,
1
which has at least one of the following
additional properties:
a) a solubility of less than 80.9% in trichlorobenzene (claims 1, 7,
and 11), more particularly 1,2,4-trichlorobenzene (claim 5);
b) the level of free radicals in the polyethylene is 1x1017/gram or less
(claims 2, 6, and 10);

1
This is a special definition. A polyethylene is generally considered a
UHMWPE when it has a molecular weight exceeding 1.7-2.5 million. See
Lue, p. 16; Li Supp. Decl. ¶ 50; Pruitt Supp. Decl. ¶ 40.
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c) a FTIR (Fourier Transform Infra-red Spectroscopy2) oxidation
index which does not increase with oven aging in air at 80° C for
up to 11 days (claims 3, 6, 7, 10, 11, and 12) or up to 23 days
(claims 4 and 8);
d) FTIR oxidation index of 0.01 (claim 11) or less (claim 12).
App. Br., Claim App’x.
Patent Owner appeals the Examiner’s decision to reject the claims
under 35 U.S.C. § 102 and § 103. The grounds of rejection are discussed
separately below as necessary.
II. Claims 1-6
ANTICIPATION BY LUE
Claims 1-6 stand rejected as anticipated under 35 U.S.C. § 102(b)
over Lue
3
as evidenced by the Clough Declaration
4
and the Wang
references.
5
RAN 3.

2
Patent Owner’s recitation of the claims states that FTIR means “Fourier
Transform Below-red Spectroscopy” (App. Br., Claim App’x)(emphasis
added), but the original claims of the ’020 patent, which were not amended
during this reexamination proceeding, states that FTIR means “Fourier
Transform Infra-red Spectroscopy”. ’020 patent, col. 12, ll. 9-10.
3
Ching-Tai Lue, “Effects of Gamma Irradiation and Post Heat Treatments
on the Structure and Mechanical Properties of Ultra High Molecular Weight
Polyethylene (UHMW-PE),” Masters Thesis, University of Lowell, 1979
(hereinafter referred to as “Lue”).
4
First Declaration of Roger L. Clough, dated January 16, 2009, and made of
record as Appendix B to the Request on January 22, 2009 (hereinafter
“Clough Declaration” or “Clough Decl.”). The Clough Declaration is
further supported by additional testimony of Dr. Clough in the Second
Clough Declaration, dated July 9, 2009, and made of record on the same
date with Requester’s Comments (hereinafter “2
nd
Clough Declaration” or
“2
nd
Clough Decl.”), and in the Third Clough Declaration, dated January 1,
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Independent claim 1 states “A medical implant comprising an
irradiated ultra-high molecular weight polyethylene having a weight average
molecular weight greater than 400,000 and a solubility of less than 80.9% in
trichlorobenzene.” Claims 1-5 depend from claim 1.
Independent claim 6 states “A medical implant comprising an
irradiated ultra-high molecular weight polyethylene having a weight average
molecular weight greater than 400,000 wherein the level of free radicals is
1x10
17
/gram or less and an oxidation index which does not increase during
oven aging in air at 80° C for 11 days.”
While many of the arguments presented in this case are directed to the
solubility property recited in claim 1, Patent Owner separately argues that
the prior art does not teach the additional properties recited in dependent
claims 2-4 and 6. App. Br. 15-17. We consider how the evidence of record
affects each of the recited properties of claims 1-6 separately, but discuss the
evidence of record with respect to each of the properties together for brevity.

2011, and made of record on January 5, 2011 with Requester’s Comments
(hereinafter “3
rd
Clough Declaration” or “3
rd
Clough Decl.”).
5
Wang A, et al., “Effects of Sterilization Methods on the Wear of Ultra-
High Molecular Weight Polyethylene Acetabular Cups,” 5th World
Biomaterials Congress, Abstract No. 275, May 28-June 2, 1996, Toronto,
Canada (hereinafter referred to as “Wang I”). Wang et al., “Effects of
Sterilization Methods on the Wear of Ultra-High Molecular Weight
Polyethylene Acetabular Cups,” 5th World Biomaterials Congress, Toronto,
Canada (1996) (hereinafter referred to as “Wang II”). Sun et al.,
“Development of Stabilized UHMWPE Implants with Improved Oxidation
Resistance via Crosslinking,” 63rd Annual Meeting of the AAOS, Feb. 22-
26, 1996, Atlanta, Georgia (hereinafter referred to as “Wang III”). Wang I,
Wang II, and Wang III are collectively referred to as the “Wang references.”
We note that the inventors of the ’020 patent, Deh Chuan Sun and Casper F.
Stark, are also authors on each of the Wang references.
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It is undisputed that Lue describes UHMWPE that has been irradiated
in an inert atmosphere and heat treated at 150°C for one hour. RAN 3; Lue,
p. 56. Lue does not teach all the properties recited in the claims. For
example, the Examiner finds that Lue describes the solubility range in
xylene for UHMWPE irradiated in air and in nitrogen, but not in
trichlorobenzene. RAN 4; Lue, p. 58-60 and 78, Table IX.
A claim may be anticipated if an element, although not explicitly
described, is inherent in a prior art disclosure. In re Robertson, 169 F.3d
743, 745 (Fed. Cir. 1999). “Inherency ... may not be established by
probabilities or possibilities.” In re Oelrich, 666 F.2d 578, 581 (CCPA
1981).
In a case such as this where patentability rests upon a property of the
claimed material not disclosed within the art, the PTO has no reasonable
method of determining whether there is, in fact, a patentable difference
between the prior art materials and the claimed material. Therefore, where
the claimed and prior art products are identical or substantially identical, or
are produced by identical or substantially identical processes, the PTO can
require an applicant to prove that the prior art products do not necessarily
possess the characteristics of his claimed product. In re Spada, 911 F.2d
705, 708 (Fed. Cir. 1990); In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
When the Examiner relies upon a theory of inherency, the Patent
Office must show a “reason to believe” that a property “asserted to be
critical for establishing novelty in the claimed subject matter may, in fact, be
an inherent characteristic of the prior art.” In re Swinehart, 439 F.2d 210,
212-13 (Fed. Cir. 1971); Best, 562 F.2d at 1254-1255.
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The Requester puts forth three rationales for finding that Lue
inherently teaches an irradiated UHMWPE having the solubility, oxidation
index, and free radical properties recited in the claims. Patent Owner
contends that Lue does not teach a UHMWPE having the solubility, free
radical or oxidation index properties recited in the claims and that none of
the Requester’s three inherency positions is sufficient for a finding that the
recited claim properties are anticipated. App. Br. 6-17. For the reasons that
follow, we find only the third rationale persuasive.

Rationale #1:“general rule”
The first rationale proposed by Requester is that, because Lue
discloses the same materials, the same irradiation process, and an annealing
process that provides equivalent heat, the properties of the UHMWPE of
Lue are inherently the same as those described in the ’020 patent. Req. Res.
Br. 3-5.
Requester argues that Lue’s annealing step of 150°C for 1 hour would
produce equivalent heat to the annealing step described in the ’020 patent of
50°C for 144 hours. Id. at 5. Requester contends that it is a general rule that
“for every 10°C increase (or decrease) in temperature, the time required for
equivalent heating is cut in half (or doubled), respectively.” Req. Res. Br. 4,
n. 3.
6

The ’020 patent teaches that free radicals are eliminated by annealing,
giving rising to an oxidation index meeting the requirement recited in some

6
According to Requester, this “general rule” was first put forth by Patent
Owner in a concurrent litigation. Id. at 4.
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of the dependent claims (col. 5, ll. 25-35). Based on experiments using an
annealing step at 50°C for 144 hours, the ’020 patent demonstrated oxidation
index and solubility meeting limits recited in the claims (col. 7, l. 51-col. 10,
l. 35, Examples 1 and 3). However, the claims are not limited to an
annealing step taking place precisely at this temperature and length of time.
The ’020 patent describes that
Compared to room temperature, an elevated temperature
. . . helps free radicals . . . to migrate in the plastic matrix to
meet other neighboring free radicals for cross linking reactions.
In general, the desired elevated temperature is between the
room temperature and the melting point of the polymer. For
UHMWPE, this temperature range is between about 25° C. and
about 140 °C. However, the preferred annealing temperature
range is from about 37° C. to about 135° C. The preferred time
and temperature is 130° C. for 20 hours with the minimum
annealing time being about 4 hours (requiring a temperature at
the high end of the range). It is to be noted that the higher the
temperature used, the shorter the time period needed to combine
free radicals.
’020 patent, col. 5, ll. 38-51 (emphasis added).
7

Nonetheless, the ’020 patent does state a minimum annealing time of
4 hours at the high end of the temperature range, and only describes
solubility and non-increasing oxidation index properties for examples that
were annealed at 50° C for 144 hours. Id., col. 7, l. 20 to col. 10, l. 35
(particular Examples 1 and 3). Based on the ’020 patent, the claimed
solubility and oxidation index would not have been considered inherent in a

7
See also ’020 patent, col. 6, ll. 36-47 (“In general, if a higher temperature
is used, a shorter time period is required to achieve a prescribed level of
oxidation resistance and cross-linking.”).

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prior art reference teaching an annealing step at a time less than 4 hours or at
a time and temperature that was not substantially identical to 50 °C for 144
hours. Thus, annealing at 150 °C for 1 hour taught by Lue is insufficient
evidence to presume that claimed solubility and oxidation index would
necessarily be as recited in any of the claims without additional evidence.
The Examiner does not appear to have adopted this rationale (RAN 5-
6 and 27-38), and we do not find this rationale to be persuasive. Requester
has not directed us to any factual support for the validity of application of
the “general rule” to irradiated UHMWPE, and has not shown that providing
“equivalent heating” would necessarily result in a UHMWPE implant having
the recited properties.
8

Rationale #2: The Wang references
The second rationale proposed by Requester and adopted by the
Examiner is that the Wang references provide evidence that Lue inherently
teaches the recited solubility in trichlorobenzene. RAN 3-5 and 30-31.
9

Wang I describes processes in which (a) UHMWPE was irradiated in
air and (b) UHMWPE was irradiated in nitrogen and stabilized at 50°C for
six days (144 hours) (“inert radiation”). Wang I, p. 2, col. 1, 2
nd
¶. Wang I
states that the percentage of insolubles (gel content) was measured in
trichlorobenzene at 170°C and in xylene at 140°C. Id., col. 2, 2
nd
¶.

8
For example, Requester has not addressed the fact that UHMWPE has a
melting point of about 140°C. Accordingly, the application of the “general
rule” may not, in fact, produce equivalent heat above 140°C.
9
The Wang references are not prior art under 35 U.S.C. § 102 and are only
relied upon as evidence of what is inherently taught by Lue and Streicher.
See Request 30, n. 5.
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Wang II describes a process in which UHMWPE is irradiated in air.
Wang II, p. 198, col. 1, 2
nd
¶. Wang II states that the percentage of
insolubles (gel content) was determined by “a high temperature solvent
extraction method” and cites to U.S. Patent 5,414,049.
10
Id., 3
rd
¶ and n. 4.
However, Wang II does not describe the solvent used and we cannot
presume the solvent described is trichlorobenzene as described in the ’049
patent. Further, Wang II does not describe a process in which UHMWPE is
irradiated in an inert environment or describe heat-stabilization of irradiated
UHMWPE.
Wang III describes processes in which (a) UHMWPE was irradiated
in air and (b) UHMWPE was irradiated in inert gas under vacuum and
stabilized by the method described in U.S. Patent 5,414,049 (which is
substantially the same disclosure as the ’020 patent). Wang III, p. 2, col. 1,
1
st
and 2
nd
¶¶. Wang III describes measuring the percentage of insolubles
(gel content) in trichlorobenzene. Id., col. 2, 2
nd
¶.
The solubilities
11
reported in the Wang references are charted below:
Wang I
TCB
12
and xylene
Wang II
solvent not
disclosed
Wang III
TCB
Air irradiation 40-55% 40-55% 54%
Inert irradiation 5-25% 25%

10
U.S. Patent 5,414,049 and the ’020 patent have substantially similar
disclosures describing measuring solubility of irradiated and annealed
UHMWPE in hot 1,2,4-trichlorobenzene. See col. 9, l. 59-col. 10, l. 64.
11
We calculate the solubility as the reverse of the reported percentage of
insolubles (gel content). App. Br. 14, n. 3; 3
rd
Clough Decl. ¶ 21. Thus,
Wang II reports a gel content of 45-60% for air irradiated UHMWPE and
75-95% for inert radiated and stabilized UHMWPE.

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and stabilized
Because the insolubles were within the same reported ranges, the
Examiner determined that the solubility of UHMWPE in xylene at 140°C
and in trichlorobenzene at 170°C are equivalent, and, thus, the solubility
measurement reported by Lue for irradiated UHMWPE in xylene at 135°C
would have been substantially the same for trichlorobenzene at 170°C.
RAN 30-31.
We disagree with the Examiner that the Wang references provide
sufficient evidence that the solubility of UHMWPE in xylene at 140°C and
in trichlorobenzene at 170°C are equivalent in order to properly to shift the
burden to Patent Owner to demonstrate otherwise. For example, Wang I, the
only one of the Wang references that states that gel content was measured in
both xylene and trichlorobenzene, provides a range of solubility of 40-55%
(air-irradiated) and 5-25% (irradiated under nitrogen and stabilized). Wang I
does not state where within this range particular data for xylene and
particular data for trichlorobenzene fall. Nor does Wang I state that the
results for the two solvents differ or are the same. Since Wang III reports
solubility for trichlorobenzene only at the higher end of the range of Wang I,
namely 54% and 25%, respectively, one might also conclude that the lower
end of Wang I reflects solubility in xylene while the higher end reflects
solubility in trichlorobenzene. The fact that Wang II reports a similar range
of solubility to that of Wang I of 40-55% but is silent as to the solvent
used,
13
and, thus, fails to clarify the range reported in Wang I. Thus, from

13
As noted above, the citation to the ’049 patent may suggest the solvent
used was trichlorobenzene. However, without a discussion in the reference
of the solvent such a conclusion is speculative. If the solvent were
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the Wang references alone, there is insufficient evidence of xylene and
trichlorobenzene equivalency, as the data may alternatively demonstrate a
difference in solubility of up to 15%. Nor are we persuaded that the Wang
references demonstrate any particular correlation between solubility in
xylene and solubility in trichlorobenzene.
Further, it is undisputed that Wang I and Wang III, the references that
describe a “stabilizing” step in addition to irradiation, describe a process
similar to that of the ’020 patent, which differs from the teachings of Lue
regarding times and temperatures for annealing. Accordingly, the Wang
references have not been shown to speak to the results of the process
described in Lue.
Notwithstanding this determination, we are not persuaded by Patent
Owner’s argument that the Wang references, in fact, reported only the
solubility measurements for xylene. App. Br. 7-11. In support of this
argument, Patent Owner relies on Wang IV,
14
the Wang Declaration,
15
and
the First Li Declaration and Supplemental Li Declaration.
16
Id.

trichlorobenzene then the source of the variability between Wang II and III
is not explained.
14
V. Krishna Polineni, et al., “Effect of Gamma-Radiation Induced
Oxidation and Crosslinking on the Wear Performance of Ultra-High
Molecular Weight Polyethylene (UHMWPE) Acetabular Cups,” Reprint
from Standard Technical Publication 1307, Am. Soc. For Testing and
Materials, pp. 95-108 (1998) (hereinafter “Wang IV”).
15
Declaration of Dr. Aiguo Wang, dated December 1, 2010, and entered into
the record on December 6, 2010, with Patent Owner’s Response (hereinafter
“Wang Declaration” or “Wang Decl.”).
16
Declaration of Dr. Stephen Li, dated June 9, 2009 and entered into the
record the same date with Patent Owner’s response (hereinafter “First Li
Declaration” or “1
st
Li Decl.”) and Declaration of Dr. Stephen Li, dated
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Wang IV describes processes in which (a) UHMWPE was irradiated
in air and (b) UHMWPE was irradiated in nitrogen and stabilized at 50°C
for 144 hours. Wang IV, p. 97-98. Wang IV reports that the percentage of
insolubles (gel content) were determined in xylene at 140°C for 24 hours
according to an ASTM test (D 2765-90).
17
Id., p. 98, last ¶. Wang IV (para.
bridging 101-102) reports an air irradiated UHMWPE solubility of 55% in
xylene and a stabilized UHMWPE solubility of 25% in xylene, which is
substantially identical with the gel contents for trichlorobenzene reported in
Wang III and thus supports, rather than contradicts, the Examiner’s position
regarding equivalency.
18

Dr. Wang is one of the authors of the Wang references and Wang IV.
Wang Decl. ¶ 6 and 9. Dr. Wang is currently an employee of the Patent
Owner and was at time of the publication of the Wang references and Wang
IV. Id. ¶ 2. Dr. Wang testifies that he has “no actual recollection as to
whether the solubility data reported in the three 1996 Wang references was
obtained using the trichlorobenzene test method disclosed in the ’020
patent.” Id. ¶ 7. Dr. Wang “doubt[s]” that the tests of the Wang references
were in trichlorobenzene because (a) Howmedica at the time used only

December 6, 2010, and entered into the record on the same date with Patent
Owner’s Response (hereinafter “Supplemental Li Declaration” or “Li Supp.
Decl.”).
17
This particular standard method for testing solubility uses xylene as a
solvent. See Request for Inter Partes Reexamination 17 and Exhibit 7.
18
We note that neither the Examiner nor the Requester rely on Wang IV in
rejecting the claims as being anticipated. Nonetheless, since Wang IV
reports xylene gel content at the lower end of the range described in Wang
II, Wang IV also further confuses rather than clarifies the range reported in
Wang II.
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xylene for in-house testing, and “we would typically have reported solubility
results determined by in-house testing” (b) “Wang IV discloses virtually the
same solubility test results as in Wang I-III for UHMWPE materials
processed in the same way,” and (c) trichlorobenzene is a relatively more
aggressive solvent for UHMWPE and solubility in trichlorobenzene will
differ from solubility in xylene. Wang Decl. ¶¶ 7-10.
Dr. Wang’s testimony is not persuasive as it is conclusory and lacking
in evidentiary support. Dr. Wang’s lack of recollection and report of
“typical” practice are not probative of what the Wang references teach to
persons skilled in the art; nor are they probative of the range of options
available to researchers at Howmedica during the periods relevant to this
appeal. In this regard, we find the testimony of Mark Jordi, that Howmedica
outsourced TCB solubility testing during the relevant period undercuts Dr.
Wang’s credibility. We note the unexplained absence of supporting
documentation regarding a critical issue in the case in light of the report in
the ’020 patent that solubility tests were conducted in TCB.
In the absence of further information from the inventors and authors,
it was reasonable for the Examiner to conclude that the reports of the Wang
references may be accepted at face value, though not conclusive as to
equivalency of the solvents as discussed above.
Finally, neither the Requestor nor the Patent Owner has directed our
attention to a direct comparison of the solubility of TCB and xylene on the
same sample of UHMWPE. Dr. Wang’s testimony that TCB is a relatively
more aggressive solvent than xylene is not supported by direct evidence, and
we have not been provided with a reasoned explanation of what a person
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having ordinary skill in the art would have expected the magnitude of the
differences in solubility, if any, to be.
Dr. Li testifies that he has extensive experience in using UHMWPE as
a material in medical devices included joint replacement. 1
st
Li Decl. ¶¶ 3-7
and 10. He has consulted for over 10 years with companies in the research,
development and testing of material, including UHMWPE used as bearing
surfaces in joint replacement. Id. ¶ 5. We find Dr. Li qualified to testify as
to research and development involved in using UHMWPE in joint
replacement.
Dr. Li testifies that the results of the Wang reference do not accurately
reflect solubility of measurements in trichlorobenzene but are consistent
with measurements taken in xylene. 1
st
Li Decl. ¶ 63-64. In support of this
position, Dr. Li relies on the discrepancy between the results reported in the
’020 patent for trichlorobenzene and in Wang IV for xylene. 1
st
Li Decl. ¶
64. Dr. Li also relies on personally conducted testing of GUR 1050
UHMWPE that was irradiated in air and nitrogen in accordance with the
solubility test method of the ’020 patent in trichlorobenzene. Li Supp. Decl.
¶¶ 6-15. Dr. Li reported solubility of greater than 100% in each case, with
one test result of 95.8% being the exception. Id. Dr. Li then compared this
solubility testing with the results reported in the ’020 patent, Wang IV, and
solubility testing data from “several years ago” for UHMWPE in xylene. Id.
at 16-24. Dr. Li reports the data as follows. Id. ¶ 21. The following table is
reproduced from page 5 of Dr. Li’s supplemental declaration (dated Dec. 6,
2010):
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Dr. Li concludes that “the solubility of UHMWPE materials in TCB
and xylene can vary from 1% to 92.2%.” Id. ¶¶ 20-21.
We do not find Dr. Li’s data to be persuasive. The distinctions
between Dr. Li’s solubility results and those of Wang IV and the ’020 patent
raise questions as to the whether the testing was of identically irradiated
UHMWPE and subsequently identically treated samples in xylene and
trichlorobenzene so as to demonstrate a distinction in the results. Similarly,
Dr. Li’s results for air-irradiated, but not annealed, UHMWPE in xylene is
not consistent with Wang IV’s results which may reflect variability between
the UHMWPE samples tested or other unexplained variables. Moreover, Dr.
Li does not provide xylene solubility testing data for any samples irradiated
in an inert environment for consistent comparison with his results in TCB.
Dr. Li further testifies that the “two solvents differ in strength for
dissolving UHMWPE.” Li Supp. Decl. ¶ 22; see also 1
st
Li Decl. ¶¶ 24-27.
Similar testimony by Dr. Wang, supra, is further supported by the testimony
of Dr. Pruitt.
19
Pruitt Supp. Decl. ¶ 20 (“[P]ersons of ordinary skill cannot

19
Declaration of Dr. Lisa Pruitt, dated June 9, 2009 and entered into the
record the same date with Patent Owner’s response (hereinafter “1
st
Pruitt
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accurately correlate or predict solubility in TCB from a known solubility in
xylene.”) (commenting on Dr. Li’s solubility Table (Li ¶ 21); see also 1
st

Pruitt Decl. ¶ 29-32 (substantially identical testimony to 1
st
Li Decl. ¶¶ 24-
27). Dr. Pruitt has 16 years of teaching experience in material science,
including conducting specific research on the effects of sterilization, aging,
and crosslinking of UHMWPE. 1
st
Pruitt Decl. ¶¶ 14-15. We find Dr. Pruitt
qualified to testify as to the effects of sterilization, aging and crosslinking of
UHMWPE.
We find this general testimony that there is in fact a difference in the
two solvents to be persuasive by preponderance of the evidence based on the
technical expertise of Dr. Li and Dr. Pruitt and the inconsistencies between
the Wang publications, suggesting that xylene and trichlorobenzene have
different solubility for UHMWPE.

Rationale #3: The Clough Declaration
The third rationale supporting Lue’s anticipation by inherency is that
the Clough Declaration shows that the procedure used in Lue does, by the
preponderance of the evidence, have the solubility, oxidation index and free
radical properties recited in the claims. RAN 3-4; Req. Res. Br. 6-8.
Dr. Clough testifies to having 30 years of experience studying the
radiation effects of polymers on oxidation and stability. Clough Decl. ¶ 3.
Dr. Clough testifies that he obtained two different resin types of UHMWPE,

Declaration” or “1
st
Pruitt Decl.”) and Supplemental Declaration of Dr. Lisa
Pruitt, dated December 6, 2010 and entered into the record on the same date
with Patent Owner’s Response (hereinafter “Supplemental Pruitt
Declaration” or “Pruitt Supp. Decl.”).
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GUR 4030 and GUR 4130, in three different manufacturing lots. Id., ¶ 22.
Dr. Clough testifies further that he prepared a detailed protocol for
reproducing the irradiation and heating procedures set forth in Lue on GUR
4030 and GUR 4130 UHMWPE samples. Id., ¶¶ 21-34 and Exhibit 2. Dr.
Clough testifies further that he set up protocols to measure the treated
UHMWPE for solubility and FTIR oxidation index at 80°C after 11 days.
Id., ¶¶ 29-30. Dr. Clough also ordered the testing of the level of free
radicals in the resulting UHMWPE samples. Id., ¶¶ 34. Dr. Clough testifies
that the protocols were followed for twelve samples from each lot, and that
the resulting solubility, FTIR oxidation index at 80°C after 11 days, and
level of free radicals all fall within the ranges recited in the claims. Id., ¶¶
29, 33, and 34. We have reviewed the protocols as well as the specific
results for each of the twelve samples from each lot and find them to be the
most detailed data presented in the record. Id. Exhibits 2-12.
Patent Owner argues that because Lue does not describe surgical
grade UHMWPE, that Lue does not teach “a medical implant” as recited in
the claims. App. Br. 17. Patent Owner’s argument is not persuasive. Lue
describes using UHMWPE in orthopedic devices and thus teaches a medical
implant. See Lue, Abstract and p. 52. We disagree that the recitation in the
preamble of a “medical implant” structurally defines the UHMWPE
otherwise recited in the claims. “[A] claim preamble has the import that the
claim as a whole suggests for it.” Bell Communications Research, Inc. v.
Vitalink Communications Corp., 55 F.3d 615, 620 (Fed. Cir. 1995); Rowe v.
Dror, 112 F.3d 473, 478 (Fed. Cir. 1997) (“[W]here a patentee defines a
structurally complete invention in the claim body and uses the preamble only
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to state a purpose or intended use for the invention, the preamble is not a
claim limitation.”). On the present record, the term “medical implant” only
imports that a UHMWPE is suitable as a medical implant if it has the
properties claimed.
Patent Owner also argues that, since Lue did not disclose a type or
grade of UHMWPE, and the GUR 4030 and GUR 4130 UHMWPE used by
Dr. Clough may not have been the same UHMWPE samples taught by Lue.
App. Br. 11-13. Patent Owner argues that Dr. Clough could have copied
the testing procedures of Lue to demonstrate similarity of material, but did
not. Id. Patent Owner further argues that inherency can only be established
on evidence that is “substantially identical” to the asserted prior art and that
the evidence is insufficient if it fills in gaps in the disclosure with mere
guesses. Id.; Req. Res. Br. 7-10.
We disagree with Patent Owner that Dr. Clough’s use of GUR 4030
and GUR 4130 UHMWPE discredits the results he provides. Lue was silent
as to the type or grade of UHMWPE treated according to the process that he
discloses. We find that Dr. Clough took reasonable steps to find similar
UHMWPE to that available at the time of Lue. Clough Decl. ¶¶ 23-26.
Accordingly, we find that the materials used by Dr. Clough to be sufficiently
similar to those used at the time of Lue to shift the burden to Patent Owner
to show that such differences are significant. Patent Owner has directed us
to no persuasive evidence to show that particular resins or grade used by Dr.
Clough would have created a significant difference in Dr. Clough’s results.
Patent Owner further argues that Dr. Cough did not perform a proper
“hot filtered” solubility test for trichlorobenzene as recited in the ’020
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patent. App. Br. 13-15; Req. Res. Br. 10-13. In this case, Patent Owner
relies on the testimony of Dr. Li, Dr. Pruitt, and Dr. Jordi as evidence that
one of ordinary skill in the art would have understood the term “hot filtered”
in the ’020 patent to require both a hot filter and a hot filtrate. App. Br. 13.
Dr. Clough testifies that hot filtration was accomplished using a high
temperature 400-mesh wire filter 0.001” thick (weighing about 0.8 g), placed
between two glass funnels, with the upper glass funnel preheated to 170°C.
The trichlorobenzene solution (150 ml), which was also at 170°C, was then
filtered. Dr. Clough testifies that the filter was not separately heated.
Second Clough Declaration ¶¶ 5-6, dated July 9, 2009, and Third Clough
Declaration ¶¶ 6, 8, and 9, dated January 1, 2011. The mass of the
undissolved polymer remaining on the filter was determined by subtracting
the mass of the filter from the mass of the filter and the mass of the
undissolved polymer following washing with methylene chloride and drying
according to the protocol (Exhibit 3) for each of twelve samples in two lots
(Exhibits 5 and 6). The solubility results range from 0.7% (sample 11A)
to 2.8% (sample 4A), with an average of 1.6% (Exhibit 5), and from 1.6%
(sample 9D) to 5.0% (Examples 6 and 11D), with an average of 2.7%
(Exhibit 6.)
Dr. Li reports conducting solubility testing of similarly irradiated
UHMWPE in trichlorobenzene with (a) a “Hot Filter, Hot Filtrate” and (b) a
“Hot Filter, Cooled Filtrate” and (c) a “Cold Filter, Cooled Filtrate”. Li
Supp. Decl. ¶ 28, Table. The particular materials used are not identified by
source and lot number, nor is the testing protocol (what was measured under
what conditions, how the reported solubility was calculated) presented in
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detail. Dr. Li does state that the “cooled/cold filtrate was obtained by
allowing the filtrate to stand at room temperature for about 10-15 minutes
before it was filtered.” Id., ¶ 28.
Dr. Li has not directed our attention to any indications that the data
presented by Dr. Clough for the twelve samples reported in each test reflect
the effect of systematic cooling. As Dr. Clough points out,
If Drs. Li and Pruitt's assumption that the sample solutions
were cooling down while waiting to be filtered was accurate,
then one would expect a downward trend in solubility data
between one filtration to the next (because under their theory,
as time passed and the samples cooled, each sample would
show lower solubility due to the precipitation of the solute.)
Third Clough Declaration, ¶ 9. No such trend, however, is evident in
Clough’s data. See Clough Decl., Exhibits 5 and 6.
We do not find Dr. Li’s evidence persuasive that Dr. Clough’s use of
a cold filter made a substantial difference to the outcome of his solubility
results. Dr. Li’s data did not show that the temperature of the filter was the
critical factor, for example, by comparing using hot and cold filters with
high temperature filtrate.
Further, Dr. Li’s described protocol suggests that his “Cooled Filtrate”
was identical to Dr. Clough’s “Cooled Filtrate,” which is not supported by
Dr. Clough’s testimony that the filtrate was not cooled, but was still 170°C.
See Third Clough Declaration ¶ 9 (“We did not allow the solutions to cool,
and the samples were filtered at approximately 170°C.”).
20

20
Dr. Clough testifies that the samples were kept in insulating heating
mantles (Third Clough Declaration ¶ 8), not left at room temperature per Dr.
Li’s “Cooled/cold filtrate” protocol. Li Supp. Decl. ¶ 28.
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Dr. Li testifies that solubilized UHMWPE would precipitate out of
solution when the temperature falls below 140°C (Li Supp. Decl. ¶ 27, but
Dr. Clough testifies that his solution was filtered at 170°C and Dr. Li directs
us to no evidence to indicate that Dr. Clough’s solution fell below 140°C.
Accordingly, Patent Owner has not persuasively shown that the
solubility test performed by Dr. Clough was substantially different such that
we could not consider his data as probative of the inherent solubility of
Lue’s treated UHMWPE.
Patent Owner has not presented any persuasive evidence disputing the
results obtained by Dr. Clough regarding level of free radicals or FTIR
oxidation index.
For these reasons, we find that Dr. Clough’s data provides a basis in
fact and/or technical reasoning to reasonably support the determination that
the properties recited in the claims necessarily were present in the
UHMWPE samples treated as described in Lue. Accordingly, a finding of
inherency is reasonable, and the burden shifts to Patent Owner to show
otherwise. Patent Owner presented no persuasive evidence that UHMWPE
treated according to Lue’s irradiation and annealing procedure does not have
the properties recited in the claims.
We affirm the Examiner’s rejection of claims 1-6 as being anticipated
by Lue.

ADDITIONAL REJECTIONS OF CLAIMS 1-6
In affirming the rejection of claims 1-6 as anticipated by Lue, it is
unnecessary to address the additional rejections maintained by the Examiner
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for claims 1-6. See In re Gleave, 560 F.3d 1331, 1338 (Fed. Cir. 2009)
(holding that obviousness rejections need not be reached upon affirming a
rejection of all claims as anticipated).

II. Claims 7-12
Independent claim 7 recites “A medical implant comprising an ultra-
high molecular weight polyethylene having a weight average molecular
weight greater than 400,000 irradiated and annealed at temperature greater
than 25 C. for a sufficient time to have a solubility of less than 80.9% in
trichlorobenzene and a non-increasing FTIR oxidation index during oven
aging in air at 80° C for up to 11 days.”
Patent Owner does not separately argue any of the claims 7-12. App.
Br. 30-31 and 33-35. We consider how the evidence of record affects each
of the recited properties of claims 7-12 separately, but discuss the evidence
of record with respect to each of the properties together for brevity.
Claims 7-12 include the further limitation that the UHMWPE is
“annealed at a temperature greater than 25° C.” The ’020 patent has expired
and may no longer be amended.
While claims are generally given their broadest possible scope
during prosecution, In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir.
2000), the Board's review of the claims of an expired patent is
similar to that of a district court's review, Ex parte Papst-
Motoren, 1 U.S.P.Q.2d 1655, 1655-56 (B.P.A.I. Dec. 23, 1986);
see also MPEP § 2258.I.G. (directing Examiners to construe
claims pursuant to Phillips v. AWH Corp., 415 F.3d 1303 (Fed.
Cir. 2005) (en banc), during reexamination of an expired patent).
In re Rambus Inc., 694 F.3d 42, 46 (Fed. Cir. 2012). We have held:
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[I]n reexamination proceedings in which the PTO is
considering the patentability of claims of an expired patent
which are not subject to amendment, a policy of liberal claim
construction may properly and should be applied. Such a policy
favors a construction of a patent claim that will render it valid,
i.e., a narrow construction, over a broad construction that would
render it invalid.
Papst-Motoren, 1 USPQ2d at 1656. “In determining the meaning of the
disputed claim limitation, we look principally to the intrinsic evidence of
record, examining the claim language itself, the written description, and the
prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic Sofamor
Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips v. AWH
Corp., 415 F3d. 1303, 1312-17 (Fed. Cir. 2005)). Importantly, it is “error ...
to use the possible invalidity of those claims, if broadly construed, as a basis
for construing them narrowly.” The Saunders Group, Inc. v. ComforTrac,
Inc., 492 F.3d 1326, 1335 (Fed. Cir. 2007); Phillips, 415 F.3d at 1327
(“[W]e have certainly not endorsed a regime in which validity analysis is a
regular component of claim construction.”).
The Examiner interpreted the language of claims 7-12 consistent with
the District Court of New Jersey to mean “annealed at a temperature of
greater than 25°C and less than the melting point of that material,
approximately 140°C.” RAN 9. Because the claims use the word anneal,
the District Court found that the ’020 patent limited an “annealing” process
to a “temperature range [that] is between about 25° C. and about 140° C.”
Howmedica Osteonics Corp. v. Zimmer, Inc., et al., No. 2:05-cv-00897-
WHW, Markman Order 28-29, dated April 23, 2007 (Request, Exhibit 2);
see’020 patent, col. 5, ll. 44-45 and col. 6, ll. 48-51.
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While Requester argues that the District Court’s interpretation is not
the broadest reasonable interpretation (Req. Res. Br. 13, n. 10), Requester
has not explained why a different interpretation of the term “annealed”
should be used in this proceeding or that we should apply a substantively
broader interpretation considering the fact that the ’020 patent is expired.
We find that the Examiner’s interpretation is consistent with the
Specification which states that “the temperature should not exceed the
distortion temperature of either the packaging material or the plastic
components. For UHMWPE, the temperature range is between about 25° C.
and about 140° C.” ’020 patent, col. 6, ll. 48-51. Accordingly, we
determine that it was reasonable for the Examiner to apply an interpretation
of claims 7-12 that requires UHMWPE that is “annealed at a temperature of
greater than 25°C and less than the melting point of that material,
approximately 140°C.”

OBVIOUSNESS OVER LUE AND LAWTON
Lue discloses annealing at 150°C and not at a temperature below
140°C. RAN 9; Req. Res. Br. 13. However, the Examiner finds that
Lawton discloses “annealing irradiated HD polyethylenes below the melting
point thereof in order to render the polyethylene products amorphous
without allowing the products to lose shape” and determines that “[i]t would
have been obvious to one of ordinary skill in the art to utilize temperatures
below the melting point in the heating step in Lue in order to minimize
oxidative degradation of the product while maintaining the product shape.”
RAN 9.
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Patent Owner argues, inter alia, that even the combined teachings of
Lue and Lawton fail to disclose the claimed solubility, oxidation index, and
level of free radicals and that “it is unrealistic that incorporating the heating
of Lawton ’897 into Lue would result in the claimed properties.” App. Br.
34-35.
Lawton discloses annealing HDPE post irradiation “at from about 90°
C. (i.e., 85-95° C.) to just below its melting point so as to render it
substantially amorphous without allowing the irradiated product to lose its
shape” (Lawton, col. 7, ll. 63-67) and specifically heats at 130 °C for 6
minutes. Id., col. 3, ll. 44-47.
As we discussed, supra, the Clough declaration provided a basis in
fact and/or technical reasoning to reasonably support the determination that
annealing at 150° C for 1 hour in the process of Lue necessarily produced
the claimed properties and shifted the burden to Patent Owner to show
otherwise. However, neither the Examiner nor the Requester has provided a
basis in fact and/or technical reasoning to reasonably support the
determination that annealing at a lower temperature at a time less than 4
hours necessarily produces the claimed properties or, alternatively, that the
claimed properties would have been obvious otherwise.
The Requester and the Examiner point out that Lue further describes
“slow cooling” after annealing for 5 hours to room temperature. RAN 36;
Req. Res. Br. 14. However, the mere reliance on 5 hours of cooling,
presumably with lower and lower temperatures as it cools, is not sufficient to
support a finding that the claimed properties are inherent or persuasive that
the claimed properties are otherwise obvious to the skilled artisan.
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Accordingly, the Examiner erred in determining that a UHMWPE
having the claimed properties would have been obvious to one of ordinary
skill in the art based on the teachings of Lue and Lawton.

ADDITIONAL REJECTIONS OF CLAIMS 7-12
The additional rejections of claims 7-12 maintained by the Examiner
include the rejection based on Dole ’83 in view of De Boer and Lawton and
the rejection based on Oonishi, Masuda, Dole ’83, Dole ’79 and Lawton.
These rejections fail for the same reasons discussed above with
respect to applying a lower temperature to the teachings of Lue. Neither the
Requester nor the Examiner has provided a basis in fact and/or technical
reasoning to reasonably support the determination that annealing at a lower
temperature at a time less than 4 hours necessarily produces the claimed
properties or, alternatively, that the claimed properties would have been
obvious otherwise.
While the prior art as a whole suggests that the objectives within the
art were the reduction of free radical due to crosslinking, low solubility and
no post-irradiation and annealing oxidation, it is not clear from the teachings
of the prior art that the skilled artisan would have had a reasonable
expectation of achieving the particular recited properties without the
hindsight reliance on the annealing times and temperature described in the
’020 patent. Further, while the prior art teaches a number of annealing times
and temperatures, the Examiner and the Requester have not shown that,
more likely than not, the skilled artisan would have recognized that the
particular required properties could be achieved at temperatures below
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140°C by optimizing these parameters, namely by increasing the annealing
time to at least 4 hours.

Lawton was discussed above. Oonishi does not disclose annealing at
all and thus was combined with Dole ’83 and Dole ’79. RAN 11 and 13.
De Boer describes annealing at 140° C for 2 hours and Dole ’79 discloses
annealing at 140° C and does not disclose an annealing time. De Boer, p.
310, 3
rd
full ¶; Dole ’79, p. 714, 2
nd
and 3
rd
full ¶. Although Dole ’79 and
De Boer describe the elimination of free radicals as observed by ESR and/or
a lack of post-annealing oxidation, the Requester and Examiner have
presented no persuasive evidence that the skilled artisan would have
expected the materials treated in this manner, but at temperatures below
140° C, to display the same elimination of free radicals and lack of post-
annealing oxidation reported in Dole ’79 and De Boer or the claimed
solubility in trichlorobenzene. Finally, Dole ’83 reports that annealing after
irradiation was known in the art but is silent as to annealing times and
temperatures. Dole ’83, p. 17, 3
rd
¶. However, there is no art of record has
been identified which suggests annealing times greater than 4 hours to
establish that the claimed properties or the times and temperatures described
in the ’020 patent are inherent or otherwise obvious to the skilled artisan as
discussed above.
The Examiner found that “[a]ll of the documentation applied in the
rejections clearly shows a direct correlation between solubility, oxidation
and the presence of free radicals, thus it naturally follows that with the
solubility met, the claimed oxidation index and level of free radicals are also
met.” RAN 37. While the evidence suggest some correlation exists between
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the reduction of free radicals and reduced oxidation,
21
the evidence does not
support finding a clear correlation of one property in the prior art to a
reasonable determination that the specific ranges for the properties recited in
the claims would have been predictable or obvious to one of ordinary skill in
the art. For example, we found persuasive that the skilled artisan would not
have been capable of predicting solubility in trichlorobenzene based only on
solubility in xylene. Likewise, there is insufficient evidence of record to
predict solubility in trichlorobenzene based on a low free radical
concentration or evidence of no post-annealing oxidation or vice versa.

SECONDARY CONSIDERATIONS
In reversing the Examiner’s position on obviousness for the reasons
discussed above, we find it unnecessary to discuss the secondary
consideration arguments of Patent Owner in detail.

SUMMARY
We affirm the Examiner’s rejection of claims 1-6 under 35 U.S.C. §
102(b) as anticipated by Lue, as evidenced by the Clough Declaration. We
decline to reach the remaining rejections of claims 1-6. We reverse each of
the rejections of claims 7-12 maintained by the Examiner.

21
See 1
st
Clough Decl. ¶ 11 (testifying that Dole made a correlation be the
elimination of all free radicals and no post-annealing oxidation, but Dr.
Clough does not opine regarding a correlation with solubility in
trichlorobenzene); see also the various properties tested in the prior art
references.
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TIME PERIOD FOR RESPONSE
In accordance with 37 C.F.R. § 41.79(a)(1), the “[p]arties to the
appeal may file a request for rehearing of the decision within one month of
the date of: . . . [t]he original decision of the Board under § 41.77(a).” A
request for rehearing must be in compliance with 37 C.F.R. § 41.79(b).
Comments in opposition to the request and additional requests for rehearing
must be in accordance with 37 C.F.R. § 41.79(c) & (d), respectively. Under
37 C.F.R. § 41.79(e), the times for requesting rehearing under paragraph (a)
of this section, for requesting further rehearing under paragraph (d) of this
section, and for submitting comments under paragraph (c) of this section
may not be extended.
An appeal to the United States Court of Appeals for the Federal
Circuit under 35 U.S.C. §§ 141-144 and 315 and 37 C.F.R. § 1.983 for an
inter partes reexamination proceeding “commenced” on or after November
2, 2002 may not be taken “until all parties’ rights to request rehearing have
been exhausted, at which time the decision of the Board is final and
appealable by any party to the appeal to the Board.” 37 C.F.R. § 41.81. See
also MPEP § 2682 (8th ed., Rev. 7, July 2008).
In the event neither party files a request for rehearing within the time
provided in 37 C.F.R. § 41.79, and this decision becomes final and
appealable under 37 C.F.R. § 41.81, a party seeking judicial review must
timely serve notice on the Director of the United States Patent and
Trademark Office. See 37 C.F.R. §§ 90.1 and 1.983.

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AFFIRMED-IN-PART

alw

PATENT OWNER:
LERNER, DAVID, LITTENBERG,
KRUMHOLZ & MENTLIK
600 SOUTH AVENUE WEST
WESTFIELD, NJ 07090

THIRD-PARTY REQUESTER:

JEFF B. VOCKRODT, ESQ.
HUNTON & WILLIAMS LLP
1900 K. STREET NW, SUITE 1200
WASHINGTON, DC 20006-1109

BRYAN RUTSCH, ESQ.
KIRKLAND & ELLIS LLP
300 NORTH LaSALLE
CHICAGO, IL 60654