Ex Parte Zhang et al

Board of Patent Appeals and Interferences

Aug 8, 2012

11326984 (B.P.A.I. Aug. 8, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ZONGTAO ZHANG, XINQING MA, JEFFREY DAVID ROTH,
T. DANNY XIAO, and JAY ALEXANDER KRAJEWSKI
__________

Appeal 2011-009624
Application 11/326,984
Technology Center 3700
__________

Before TONI R. SCHEINER, MELANIE L. McCOLLUM, and ERICA A.
FRANKLIN, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a medical
device and method. The Examiner has rejected the claims for lacking
written description and for being obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.
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Application 11/326,984

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STATEMENT OF THE CASE
Claims 1, 4-12, 17-21, 23-31, 35-38, 40, and 41 are on appeal (App.
Br. 2 & 8).
1
The claims subject to each rejection have not been argued
separately and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii).
Claim 1 is representative and reads as follows:
1. A medical device, comprising a structural member having a
surface wherein at least a portion of the surface is coated with a
nanostructured material to a thickness of at least about 25 micrometers, and
wherein the nanostructured material comprises a ceramic, ceramic
composite, ceramic metal composite, or a combination comprising at least
one of the foregoing, wherein the nanostructured material has a hardness of
1,250 kgf/mm
2
to 8,000 kgf/mm
2
measured using a Vicker‟s Test Model
M-400-G2 at 300 gram (g), 1 kilogram (kg) and 2kg loads; wherein the
nanostructured material comprises a hard phase ceramic oxide; and wherein
the medical device is an artificial implant that comprises at least a portion of
an articulating joint or a flexible hinge joint.
Claims 1, 20, and 38 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement
(Ans. 3).
Claims 1, 4-12, 17-21, 23-31, 35-38, 40, and 41
2
stand rejected under
35 U.S.C. § 103(a) as obvious over Wang et al. (US 2003/0008764 A1,
Jan. 9, 2003) in view of Davidson (US 5,037,438, Aug. 6, 1991) (Ans. 4).
WRITTEN DESCRIPTION
The Examiner finds: Claims 1, 20, and 38 “each recite „hard phase
ceramic oxide‟, which does not appear to be adequately supported in the

1
Claims 14-16, 33, 34, and 42-52 are also pending but have been withdrawn
from consideration (App. Br. 2).
2
The Examiner‟s Answer also lists claim 39 as rejected (Ans. 4). However,
claim 39 has been cancelled (App. Br. 2).
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original claim set or in the specification as filed. The examiner is unsure
whether appellant meant to claim -- hard phase metal oxide --, as previously
recited in the claims.” (Ans. 3.)
Appellants agree that the “term should be „hard phase metal oxide‟
and not „hard phase ceramic oxide‟ as presently claimed” (App. Br. 8). We
therefore affirm the written description rejection.
OBVIOUSNESS
The Examiner relies on Wang for teaching “a nanostructured multi-
component ceramic comprising a major ceramic phase comprising a ceramic
oxide composite, a ceramic oxide-additive, and a rare earth ceramic oxide
additive” and that the “ceramic composites taught by Wang may be used as
feedstocks for thermal spray coatings and show improved density, impact
strength, wear resistance, corrosion resistance, toughness, thermal shock
resistance, and increased bond strength between coatings and matrices”
(Ans. 4). The Examiner finds that “the major ceramic oxide phase, taught
by Wang . . . , meets the limitation of the ceramic comprising a hard phase
metal oxide, as claimed by appellant” (id.). The Examiner also finds that
Wang teaches “coatings ranging in thickness from 25 microns to several
millimeters” (id. at 5). In addition, the Examiner finds that “Wang
acknowledges the advantageous properties of ceramic oxide coatings in a
number of applications, including medical implants” (id.). The Examiner
also finds that Wang “teaches a hardness number of 950-1100 VHN” (id. at
6).
The Examiner acknowledges that “Wang does not explicitly teach an
artificial implant comprising at least a portion of an articulating joint or a
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flexible hinge joint, or a hardness of 1,250 kgf/mm
2
to 8000 kgf/mm
2
” (id.).
However, the Examiner finds:
Davidson teaches orthopedic implants, such as hip, elbow, or
knee joints (articulating joints), of zirconium or zirconium-
based alloy coated with zirconium oxide . . . , for the purpose of
reducing the coefficient of friction between articulating surfaces
so that less heat and torque is generated and less wear of the
mating bearing surface results.
(Id.) The Examiner also finds that Davidson teaches “a hardness value of
1700-2000 Knoop . . . , which meets the claimed limitation” (id.). The
Examiner concludes:
[I]t would have been obvious to one having ordinary skill in the
art to apply the coatings of Wang to a medical device since it is
recognized by Wang that these coatings are advantageous in the
art of medical implants, in order to provide wear, corrosion, and
thermal protection. It also would have been obvious to one
having ordinary skill in the art to modify the hardness value of
the coating taught by Wang to include a higher hardness value
such as that taught by Davidson, in order to increase wear-
resistance as desired for articulating joints.
(Id. at 10.)
Analysis
We incorporate the Examiner‟s statement of the rejection and
response to arguments as set forth in the Examiner‟s Answer. We include
the following additional comments.
Wang may not expressly disclose using its ceramic oxide composites
for coating medical implants (see Wang, ¶ [0049]). However, as noted by
the Examiner (Ans. 4), Wang does disclose that ceramic oxide coatings
“have found broad utility in a number of demanding technical applications,
such as . . . medical implants” (Wang, ¶ [0003]). In addition, Davidson
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discloses orthopedic implants coated with zirconium oxide (Davidson,
Abstract). Thus, we agree with the Examiner that it would have been
obvious to coat Davidson‟s implants with Wang‟s ceramic oxide composites
(Ans. 10). In addition, as noted by the Examiner (id. at 5), Wang discloses
the “formation of a dense coating . . . ranging in thickness from 25 microns
to several millimeters” (Wang, ¶ [0048]).
With regard to the claimed hardness, we recognize that Wang
discloses an embodiment having a “hardness of from 950 up to 1100 VHN”
(id. at ¶ [0075]). However, we conclude that the Examiner has set forth a
prima facie case that it would have been obvious to form a coating having a
hardness of 1,250 to 8,000 kgf/mm
2
(Ans. 7). Appellants argue that they
“believe that it would not be possible to modify the hardness value of the
coating by Wang to include a higher hardness value such as taught by
Davidson” (App. Br. 11-12). However, in the absence of any evidence
supporting this belief, we are unpersuaded by this argument.
Moreover, Appellants have not provided sufficient evidence that the
claimed hardness provides an unexpectedly superior result. Table 1 of the
Specification indicates that a claimed ceramic coating, which has a hardness
of 1250 kg/mm
2
, has an estimated life span of 15 to 25 years, whereas a
prior art coating, which has a hardness of 1200 kg/mm
2
, has an estimated life
span of 15 years (Spec. 17). Even assuming that an estimate of 15 to 25
years is an improvement over an estimate of 15 years, this is not a
comparison to the closest prior art. In addition, Appellants have not
provided evidence indicating that it would have been unexpected that higher
hardness would provide a longer life span.
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Conclusion
The evidence supports the Examiner‟s conclusion that the medical
device of claim 1 would have been obvious. We therefore affirm the
obviousness rejection of claim 1. Claims 4-12, 17-21, 23-31, 35-38, 40, and
41 fall with claim 1.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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