Ex Parte Durcan et al

Patent Trial and Appeal Board

Oct 31, 2012

11057022 (P.T.A.B. Oct. 31, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JONATHAN P. DURCAN and KERRY J. WILLIAMS
__________

Appeal 2011-006871
Application 11/057,022
Technology Center 3700
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Before JAMESON LEE, RAE LYNN P. GUEST, and
RAMA G. ELLURU, Administrative Patent Judges.

ELLURU, Administrative Patent Judge.

DECISION ON APPEAL

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Appellants appeal under 35 U.S.C. § 134(a) from the Final Rejection
of claims 1, 2, 4, 6-9, and 11-21, all the pending claims in the application.
The real party in interest is Abbott Cardiovascular Systems, Inc. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
The Applied Prior Art
Shin US 6,063,092 May 16, 2000
Huang US 2003/0032999 A1 Feb. 13, 2003
Igaki US 2003/0033001 A1 Feb. 13, 2003
Shalaby US 2003/0199964 A1 Oct. 23, 2003

The Rejection on Appeal
Claims 1, 2, 4, 6-9, and 11-21 were finally rejected under 35 U.S.C. §
103(a) as obvious over Huang, Igaki, Shalaby, and Shin. (Ans. 4-8).
The Invention
The claimed invention relates to catheters, and particularly
intravascular catheters for use in the delivery of stents. (Spec. § [0001]).
For example, in one embodiment, a stent mounted on the balloon catheter is
embedded in an outer surface of an elastomeric sleeve on the catheter
balloon in order for the stent to form an imprint in the outer surface of the
sleeve. (Id. at § [0005]). The stent is securely mounted on the balloon
because of the interference with the imprinted sleeve. (Id.)

Claim 1 is reproduced below:
1. A stent delivery balloon catheter, comprising
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a) an elongated shaft having an inflation lumen and a guidewire
lumen;

b) an inflatable balloon on a distal shaft section, having an interior
in fluid communication with the inflation lumen, said balloon having
a folded configuration with wings wrapped around its circumference;

c) an elastomeric sleeve on an outer surface of the balloon, and the
sleeve has a proximal end section and a distal end section
longitudinally adjacent to an expandable section of the sleeve, and at
least one of the proximal and distal end sections are bonded to an
outer surface of the catheter shaft or balloon, and the expandable
section of the sleeve is not bonded to the balloon, said sleeve having a
circular cross-section; and

d) an expandable stent which has struts, which is not adhesively
bonded to the sleeve, which has a therapeutic agent, and which is
releaseably mounted on an outer surface of the sleeve, with an imprint
of the stent in an outer surface of the sleeve in a noninflated
configuration, an inflated configuration, and a deflated configuration
after the inflated balloon is deflated to radially collapse the balloon
and sleeve away from the expanded stent, such that portions of the
sleeve protrude between adjacent struts of the stent mounted on the
sleeve and partially encapsulate side surfaces of the stent, and the
sleeve has a scalloped shape when viewed in a transverse cross
section with the stent mounted thereon which is formed by protruding
portion spaced from and between two adjacent struts rising to a
maximum outer diameter at about a midpoint between the two
adjacent struts.

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DISCUSSION
35 U.S.C. § 103(a): Rejection of Claims 1, 2, 4, 6-9, and 11-21 over Huang,
Igaki, Shalaby, and Shin
The Examiner finds that Huang teaches a stent delivery catheter
comprising an inflatable balloon (21), and an elastomeric sleeve (22)
positioned on the outer surface of the balloon. (Ans. 4 (citing Huang Fig.
1)). The Examiner also finds that Huang does not specifically disclose the
inflatable balloon as comprising a folded configuration. (Id. at 4).
The Examiner, however, finds that Shin teaches a balloon mounted on
a stent delivery catheter, wherein the balloon is folded over in a well-known
S-fold configuration that creates wings wrapped around the catheter in order
to provide a low profile. (Id. at 5 (citing Shin (col. 2, ll-56-57; col. 2, ll. 57-
60)). The Examiner concludes that it would have been obvious for the
Huang balloon to be folded as modified by the Shin folding technique
because folding a balloon is both beneficial and well-known as taught by
Shin. (Id.). The Examiner explains that folding Huang’s balloon, according
to Shin, comprises two variations. (Id.) According to the first variation,
both Huang’s balloon (21) and sleeve (22) are folded together, wherein the
folded sleeve would comprise a circular cross section. (Id. a 5-6).
According to the second variation, only Huang’s balloon (21) is folded, and
thus, the sleeve (22) retains the same shape and maintains a circular cross
section as originally disclosed by Huang. (Id. at 6 (citing Huang Fig. 3)).
The Examiner concludes that it would have been obvious to only fold
Huang’s balloon (21) because Huang teaches the balloon (21) and sleeve
(22) are two separate components and entities and Shin teaches folding of an
inner balloon. (Id. at 6). Specifically, the Examiner finds that Huang
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teaches the balloon (21) and sleeve (22) comprise different materials, and
concludes that because the outer sleeve (22) functions to just maintain the
stent on the inner balloon (21), it would have been obvious to fold only the
inner balloon. (Id. at 6 (citing Huang §§ [0020]-[0026])).
Appellants first argue that Huang’s outer layer cannot be fairly
characterized as a sleeve on the balloon. (App. Br. 7; Reply Br. 2).
According to Appellants, Huang considers the outer layer (22) to comprise
the balloon, or at least the outermost layer of the balloon, because Huang
describes the balloon as comprising “‘at least one non-tacky outer layer 22
and at least one inner layer 21.’” (Id. at 7-8 (citing Huang § [0022])).
Appellants maintain that because layer 22 is the outer layer of Huang’s
balloon, an elastomeric sleeve, as claimed, must be present on top of layer
22. (Id. at 8). We disagree.
As the Examiner correctly explains, even though Huang uses different
terms for the claimed members, the outer and inner layers of Huang’s
balloon teach the claimed sleeve and balloon. (Ans. 9). The Examiner
reasonably equates only Huang member (21) with the claimed balloon, and
member (22) with the claimed sleeve. (Id.). The Examiner further correctly
finds that Huang teaches an outer sleeve layer (22) over inner layer balloon
layer (21) and the layers 21 and 22 are comprised of different materials with
different properties so that that the two layers are separate components. (Id.
(citing Huang Fig. 2; § [0026])).
Appellants next argue that Huang’s outer layer does not satisfy the
claimed “the expandable section of the sleeve is not bonded to the balloon”
because Huang’s outer layer is bonded to the inner layer of the balloon.
(App. Br. 9; Reply Br. 2-3). We disagree.
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As the Examiner correctly explains, Huang teaches that the inner and
outer layers “may comprise” a laminate so that Huang in not limited to a
laminate, i.e., it is only one embodiment. (Ans. 9). The Examiner further
notes that Huang is modified by Igaki which teaches having a separate
sleeve (12) extending past the distal and proximal edges of the balloon (5).
(Id. at 9-10 (citing Igaki Figs. 4, 6, and 8)). The Igaki bonding clears the
balloon and advantageously does not obstruct the dilation of the balloon.
(Ans. 10 (citing Igaki § [0070])). The Examiner reasonably concludes that,
therefore, it would have been obvious for Huang’s outer sleeve layer (22) to
also extend past the balloon and only be bonded to the catheter. (Ans. 10).
Indeed, Huang teaches that outer layer (22) may cover varying proportions
of the inner layer (21), which includes the entire inner layer. (Id. (citing
Huang § [0022])). The Examiner further reasonably concludes that because
Igaki teaches a known method to attach an outer sleeve layer to a balloon
catheter, modifying the Huang device with Igaki involves the simple
substitution of one known element for another to obtain predictable results
of a balloon and stent expansion. (Ans. 10).
Lastly, Appellants argue that folding Huang’s balloon as modified by
Shin would not render Huang’s outer layer circular. (App. Br. 10; Reply Br.
3-4). According to Appellants, the claim limitation that the sleeve has a
circular cross-section is redefined to include Shin’s folded configuration, but
Shin’s “s-fold” configuration is not “‘circular in shape,’” as claimed. (Id. at
10). Specifically, Appellants maintain that because Huang’s balloon 20 has
joined inner and outer layers, the balloon’s inner layer cannot be folded
while the outer layer remains circular. (Id.). Thus, Appellants contend that
the balloon is folded in Shin’s s-fold configuration, in which case all of its
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layers assume a folded shape which is not circular in shape, or its outer layer
is circular, in which case all layers bonded thereto are circular and thus
cannot include the s-fold configuration. (Id.). We are not persuaded by
Appellants’ argument.
As discussed above, we agree with the Examiner’s finding that Huang
teaches the balloon as comprising two layers (21 and 22), each of which is
comprised of a different material with different properties. (Ans. 10).
Further, Huang only teaches that the inner layer (21) may comprise varying
configurations. (Id. citing (Huang § [0022])). Because Huang teaches two
distinct layers wherein only the inner layer can be modified, we agree that it
would have been obvious for only Huang’s inner layer to be modified
according to Shin’s well-known s-fold configuration. (Ans. 10-11 (citing
Shin col. 2, ll. 56-60, col. 5, ll. 13-15)). Thus, we agree that folding Huang’s
inner layer (21) as modified by Shin would allow Huang’s outer layer (22) to
have a circular cross-section, as claimed.
In sum, we conclude, as discussed above, that the rejection of claim 1
as being obvious over Huang, Igaki, Shalaby, and Shin is supported by a
preponderance of evidence. Appellants do not argue separate patentability
for independent claims 11 and 12, and all claims depending from claims 1,
11, and 12. Thus, for the same reasons discussed above, we conclude that
the rejection of claims 2, 4, 6-9, and 11-21 as being obvious over Huang,
Igaki, Shalaby, and Shin is supported by a preponderance of evidence.
Additional Arguments Raised by Appellants
We have considered only the arguments presented by Appellants in
the opening Appeal Brief. In their Reply Brief, Appellants argue that: (1)
there is no motivation to combine or apply the teachings of Shin to the
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Huang reference (Reply Brief 3), and (2) Shin teaches away from the present
invention because Shin teaches an intermediate step wherein a circular
sheath is temporarily positioned about the folded balloon and then
subsequently removed (id. at 3-4). We dismiss these arguments because
they are not entitled to consideration as they are newly presented in the
Reply Brief. See Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010)
(“informative” 1) (“[T]he reply brief [is not] an opportunity to make
arguments that could have been made in the principal brief on appeal to
rebut the Examiner's rejections, but were not.”).
In the alternative, we note that the Examiner identifies the motivation
to modify Huang’s inner layer (21) according to Shin (see Reply Br. 3) as
lowering the overall profile for the Huang delivery device and involving
only the use of a known technique to improve the Huang device. (Ans. 11).
Thus, we conclude the Examiner has provided an articulated reasoning with
rational underpinnings to support the conclusion of obviousness. KSR Int'l
Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007). We further conclude that
Shin does not teach away from the present invention because it only
expresses a preference for temporarily positioning a circular sheath about the
folded balloon and removing it prior to the crimping of a stent onto the
balloon. A reference does not teach away if it merely expresses a general
preference for an alternative invention from amongst options available to the
ordinarily skilled artisan, and the reference does not discredit or discourage
investigation into the invention claimed. In re Fulton, 391 F.3d 1195, 1201
(Fed. Cir. 2004). Appellants have not pointed to any teaching in Shin, and

1 The “informative” status of this opinion is noted at the following Board
website: http://www.uspto.gov/ip/boards/bpai/decisions/inform/index.jsp.
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we have found none, that indicates leaving the sheath about the folded
balloon would be ineffective or should not be attempted.

CONCLUSION
The rejection of claims 1, 2, 4, 6-9, and 11-21 under 35 U.S.C. §
103(a) as obvious over Huang, Igaki, Shalaby, and Shin is affirmed.
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