Ex Parte Jagger et al

Patent Trial and Appeal Board

Oct 23, 2012

11496249 (P.T.A.B. Oct. 23, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte KARL JAGGER, TRACEE EIDENSCHINK,
DEREK SUTERMEISTER, DANIEL GREGORICH,
YOUSEF ALKHATIB, MATT HEIDNER, ADAM JENNINGS,
RICHARD C. GUNDERSON, JOHN BLIX, TIMOTHY J. MICKLEY,
RICHARD OLSON, JAN WEBER, and DOMINICK GODIN
__________

Appeal 2011-006284
Application 11/496,249
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC GRIMES, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
catheter including a stent retaining device comprising an electroactive
polymer. The Examiner has rejected claim 1 as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.

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STATEMENT OF THE CASE
The Specification discloses a catheter system comprising a catheter, a
stent, and a retaining device including an electroactive polymer (Spec. 3).
Figures 11a and 11b show an embodiment:

Figure 11a depicts a side view of a catheter with a sheath (30) disposed
about the length of a stent (10), while Figure 11b shows a side view of a
catheter with a sheath retracted from about the stent (id. at 4). As shown
above, sheath (30) having an electroactive polymer (EAP) portion (34) is
disposed about the length of stent (10) in an inactivated state (Figure 11a),
and rolls off the stent when activated (Figure 11b) (Spec. 20). Electrical
activation of the EAP sheath results in the sheath curling back and allowing
the stent to deploy (id.).
Claim 1 is the only claim on appeal and reads as follows:
1. A catheter comprising:
a medical device receiving region;
a stent disposed about the medical device receiving region in a
reduced state for delivery; and
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a stent retaining device which is activatable to release the stent,
wherein the retaining device comprises an electroactive
polymer, the retaining device having different first and second shapes
corresponding to activated and inactivated states of the electroactive
polymer, and the retaining device configured to effect release of the
stent as a result of a shape change in said portion induced by
activation or inactivation of the electroactive polymer therein;
wherein the retaining device is at least one sheath having a first
portion and a second portion;
wherein, in the inactivated state, the first portion of the at least
one sheath is disposed about a length of the stent and, in the activated
state, the first portion of the at least one sheath is curled back such
that the first portion of the at least one sheath is disposed about the
second portion of the at least one sheath.
Claim 1 stands rejected under 35 U.S.C. § 103(a) as obvious over
Mattison (U.S. Pat. Appl. Publ. No. 2005/0102017 A1, published May 12,
2005) in view of Wang et al. (U.S. Pat. No. 6,478,814 B2, issued Nov. 12,
2002).
Analysis
Claim 1 recites a catheter comprising a retaining device comprising an
electroactive polymer. The retaining device has “different first and second
shapes corresponding to activated and inactivated states of the electroactive
polymer,” and in the activated state, a first portion of a sheath “is curled
back such that the first portion of the [] sheath is disposed about the second
portion of the [] sheath.”
The Examiner acknowledges that Mattison does not teach a sheath
that “changes shape by rolling back over itself” (Ans. 4). The Examiner
asserts that Wang teaches this feature, and that it “would have been obvious
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to one of ordinary skill in the art to modify the device of Mattison „017 with
a retaining sleeve that rolls back, as taught by Wang „814, in order to make it
easier to release the stent” (id., see also id. at 5 (stating it would have been
obvious to configure the EAP sleeves in Mattison “to cause the claimed
shape change in order to provide the advantages taught by Wang „814”).
Like the Examiner, we find that Mattison discloses a delivery sheath,
i.e., a retaining device, comprising an electroactive polymer (EAP), where
the retaining device has different shapes corresponding to activated and
inactivated states of the EAP (Ans. 4; Mattison [0022], [0028]).
Specifically, Mattison teaches that the EAP in the retaining device expands
and contracts to tighten and relax the device‟s hold on the stent (Mattison
[0028], [0031], [0043], [0044]). Mattison does not disclose or suggest
curling back a retaining device, or that EAP could facilitate a curl back (Ans.
4). We agree with the Examiner that Wang discloses end sleeves, i.e.,
retaining devices, that “roll back upon themselves” (Wang, col. 6, ll. 53-60,
col. 7, ll. 31-57; see also Figures 3, 4, 8, 9) (Ans. 4).
Notably, however, the “roll back” feature disclosed in Wang relies on
the properties of polytetrafluoroethylene (PTFE), a thermoplastic polymer,
present in Wang‟s retaining device (Wang, col. 2, ll. 48-56; col. 4, ll. 16-18;
col. 6, ll. 53-60; col. 7, ll. 51-57). In relation to this polymer, Wang teaches
that a sleeve having PTFE “will have inner and outer surface characteristics
which will attract one another,” and as a result, sleeves “tend to roll back
upon themselves when the balloon 12 is placed in the inflated state” (id. at
col. 6, ll. 53-60). Similarly, Wang states that “[a]s a result of the physical
characteristics of the inside and outside hydrophobic coatings, sleeves 16, 18
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will tend to roll back upon themselves when the inflatable portion 12 is in
the inflated state” (id. at col. 7, ll. 53-57). Thus, it is the properties of the
particular polymer used in Wang that cause the retaining device to curl back
in an activated state.
As noted by Appellants, the Examiner does not establish that Mattison
or Wang, alone or in combination, teach or suggest that a retaining device
“comprised of an electroactive polymer can curl back over itself when the
electroactive polymer is activated” (App. Br. 10). For example, the
Examiner does not suggest, or cite to evidence indicating, that an EAP has
relevant characteristics similar to those of PTFE. In addition, Mattison
discloses examples of EAP (Mattison [0023]) and Wang discloses
“examples of suitable hydrophilic materials which may be utilized to coat
the sleeve surfaces” (Wang, col. 6, ll. 47-52), but the two references do not
list overlapping material.
Here, Examiner has not established by a preponderance of the
evidence that it would have been obvious to an ordinary artisan “to
configure the electroactive polymer portions in the sleeve [of Mattison] to
cause the claimed shape change in order to provide the advantages taught by
Wang „814” (Ans. 5). Merely citing to “advantages taught by Wang” (Ans.
5, 4) is insufficient to show obviousness absent additional information or
evidence, such as that indicating how one would have, or could have,
configured the retaining device comprising EAP in Mattison accordingly.
A rejection on the ground of obviousness must include “articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). “[T]his
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analysis should be made explicit” and it “can be important to identify a
reason that would have prompted a person of ordinary skill in the relevant
field to combine the elements in the way the claimed new invention does.”
KSR Int’l Co., v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Because the Examiner does not explain or suggest how the cited
references would have prompted one to modify a retaining device
comprising EAP so that it curled back, rather than simply expand and
contract as taught in Mattison (Mattison [0043]), the Examiner fails to
present a prima facie case.
SUMMARY
We reverse the rejection of claim 1 as obvious under over Mattison in
view of Wang.

REVERSED

cdc