Ex Parte Kleiner

Patent Trial and Appeal Board

Jan 7, 2016

12422783 (P.T.A.B. Jan. 7, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/422,783 04/13/2009
44955 7590 01/11/2016
SQUIRE PB (SFR Office)
275 BATTERY STREET, SUITE 2600
SAN FRANCISCO, CA 94111-3356
FIRST NAMED INVENTOR
Lothar W. Kleiner
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
062571.00366 7359
EXAMINER
MATHEW, SEEMA
ART UNIT PAPER NUMBER
3738
NOTIFICATION DATE DELIVERY MODE
01111/2016 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
sfripdocket@squirepb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LOTHAR W. KLEINER
Appeal2013-004175
Application 12/422,783 1
Technology Center 3700
Before MICHAEL L. HOELTER, THOMAS F. SMEGAL, and
MICHAEL L. WOODS, Administrative Patent Judges.
SMEGAL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Lother W. Kleiner (Appellant) seeks our review under 35 U.S.C.
§ 134 of the Examiner's Non-Final Rejection under 35 U.S.C. § 103(a) of
claims 21-25 as unpatentable over Zachariades (US 4,944,97 4, iss. July 31,
1990) and Huang (US 2007/0179219 Al, pub. Aug. 2, 2007). 2 We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 According to Appellant, the real party in interest is Abbott Cardiovascular
Systems Inc. Appeal Br. 2.
2 Claims 1-20 were canceled.
Appeal2013-004175
Application 12/422,783
CLAIMED SUBJECT MATTER
Sole independent claim 21 is reproduced below and is representative
of the claimed subject matter.
21. A stent comprising a scaffolding including a
plurality of structural elements comprising:
an abluminal layer and a luminal layer;
wherein one of the layers is an ultra high molecular
weight (UHMW) layer made from a UHMW bioabsorbable
polymer having a weight average molecular weight greater than
1 million g/mole, and
wherein the other layer is a low molecular weight
(LMW) layer made from a low LMW bioabsorbable polymer
having a weight average molecular weight of between 50,000-
300,000 g/mole.
OPINION
We are persuaded by Appellant's arguments that the Examiner failed
to establish a prima facie showing of obviousness in rejecting claims 21-25
over Zachariades and Huang. See Appeal Br. 4---6; Reply Br. 2-5.
The Examiner finds that
Zachariades discloses a stent in Figures 4--6, wherein the stent
comprises an abluminal layer and luminal layer 20, 22 wherein
the [layers are comprised] of a ultra-high molecular weight
polymer and a lower molecular weight polymer, wherein the
polymer is selected from poly (1-lactide ), wherein the molecular
weight can be as low as 60,000 to 300,000.
Ans. 4--5 (citing Zachariades col. 1, 11. 35-55, col. 3, 11. 1-30, col. 4, 11. 7-
25, and col. 5, 11. 15--45).
The Examiner also finds that Huang
teaches a stent #200 in Figure 2, wherein the stent can be a
woven structure [citing Huang i-fi-1 4, 35] comprising a stent
body for supporting a vascular lumen [citing Haung i1 4]
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Appeal2013-004175
Application 12/422,783
wherein the stent body is formed of a bioabsorbable polymer
such as poly (L-lactide) [citing Huang i-fi-1 30, 37] and a
therapeutic agent mixed or dispersed in the bioabsorbable
polymer for the purpose of providing therapeutic relief to the
implanted site [citing Huang i-fi-15, 35, 38, 53, and] discloses the
bioabsorbable polymer to be an ultrahigh molecular weight
polymer having a molecular weight greater than about 1 million
g/mole and polymers that have molecular weight of 50,000-
300,000 g/mole.
Id. at 5 (also citing Huang i-f42). From the foregoing, the Examiner reasons
"it would have been obvious . . . to modify Zachariades' s stent to further
include an ultra-high molecular weight polymer having a molecular weight
greater than about 1 million g/mole for the purpose of increasing the
mechanical strength and modulus of the stent layer." Id.
However, Appellant points out that "the composite structures of FI Gs.
4 and 5 [of Zachariades] are made up of sheets and knitted structures, both
of which are made ofUHMWPE (ultra high molecular weight
polyethylene);" and neither of these structures "includes a sheet or k_nitted
structure that is made up of a lower molecular weight polymer with a
molecular weight that can be as low as 60,000 to 300,000." Appeal Br. 4.
While acknowledging that Zachariades does disclose at column 3, lines 1-
30, that "a lower molecular weight polymer can be as low as 60,000 to
300,000," Appellant explains that "[t]he disclosure at col. 3, lines 6-17 [of
Zachariades] relating to low weight average molecular weight polyethylene
[] is provided only to compare the properties of UHMWPE with the lower
molecular weight polyethylene." Id. at 5---6.
In response, the Examiner appears to change the rejection, for the first
time reasoning that "Zachariades teaches a composite prepared by using a
matrix of polyethylene having a weight average molecular weight of 60,000
3
Appeal2013-004175
Application 12/422,783
and a reinforcing fiber component of ultra-high molecular weight
polyethylene having a molecular weight greater than 3 million (column 2,
lines 45---67 and column 3, lines 10-20)." Ans. 6. Based on the foregoing
Id.
the examiner interprets [that] the pre-formed composite (prior
to becoming a single phase composite) includes an abluminal
sheet and a luminal sheet, wherein [one] sheet comprises a low-
molecular weight polymer having [a molecular weight of]
60,000 to 300,000 and another sheet comprises a ultra-high
molecular weight of greater than 1 million.
Appellant first points out that "[Huang] does not disclose that UHMW
polymers to be polymers greater than 100,000 or that have molecular weight
of 50,000-300,000." Reply Br. 3. Appellant also submits that "[t]he
Examiner is [now] interpreting a pre-formed composite (prior to becoming a
single phase composite) as 'a stent comprising a scaffolding including a
plurality of structural elements comprising: an abluminal layer and a luminal
layer;"' even though "[ t ]he sheets [of Zachariades] at best are a precursor to
a stent," and explains that "[t]he forming method disclosed (column 3, lines
6-8) is melt crystallizing the matrix on the reinforcing fibers," and "[even]
if a well-defined melt-layer is present at some time before the melt mixes
with the fibers, it is not reasonable to interpret a polymer melt over a fiber
layer as a stent." Id. at 4.
We agree with Appellant that the Examiner's finding that Zachariades
discloses "an abluminal sheet and a luminal sheet, wherein [one] sheet
comprises a low molecular weight polymer ... and another sheet comprises
a ultra-high molecular weight" is not supported by the Record. Id.; see Ans.
6. We also find that the Examiner has not articulated adequately an apparent
reason why a person of ordinary skill in the art would have been prompted,
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Appeal2013-004175
Application 12/422,783
by the disclosure in Zachariades of a pre-formed composite, to form a stent
of structural elements from separate layers of bioabsorbable polymers
having weight average molecular weights, as recited by claim 21. As
explained by our reviewing court, "rejections on obviousness grounds
cannot be sustained by mere conclusory statements; instead, there must be
some articulated reasoning with some rational underpinning to support the
legal conclusion of obviousness." In re Kahn, 441 F.3d 977, 988 (Fed. Cir.
2006) (citation omitted) (quoted with approval in KSR Int 'l Co. v. Teleflex
Inc., 550 U.S. 398, 418 (2007)).
For the foregoing reasons, we do not sustain the Examiner's decision
rejecting claims 21-25 over Zachariades and Huang.
DECISION
We REVERSE the Examiner's rejection.
REVERSED
msc
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